Author Archives: K Eckland

The Chicago Tribune, Medical Tourism and Patient Safety

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The Chicago Tribune recently published an article about medical tourism  by Alexia Elejalde Ruiz that quotes Joseph Woodman pretty heavily.  He writes about medical tourism and quality but from more of a statistical and policy perspective (no medical background.)

The article was written to give tips to potential medical travelers, and mentions JCI accreditation and standards etc.  I think this shows a growing awareness among the media and consumers that there is a need to regulate this industry to protect patients from harm.

Unfortunately, this article did not go into more detail, and despite mentioning Colombia in the article subtitle, there was nothing further about Colombia in the article.

Too bad – as my long time readers know – my entire purpose and mission in writing and researching this book was to provide consumers with exactly this sort of information  – from first hand observation.

“Hospitals riskier than airplanes”

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It looks like our last post,  Reputation, Rankings and Objective Measures was more timely than I ever expected.  While I always feel urgency over patient safety issues – now the news media has joined in after the release of the latest World Health Organization report.  For more about this report – see our posting at Cartagena Surgery.  Hopefully, this media attention will help the public to understand why books such as this are needed.

In other news – the first shipment of books for transportation to Bogotá has arrived!

World Health Information & Patient Safety

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As Bogotá Surgery readers know, we were just talking about the  relevance of hospital rankings, and scorecard criteria for patient safety and optimal patient outcomes.  In particular, we were talking about the use of this criteria  (along with Core Measures) as just one of the ways surgeons, hospitals and surgical programs are evaluated for Bogotá! a hidden gem guide to surgical tourism.

Now several news outlets have picked up the story under the headline, “Hospitals riskier than airplanes.”

Reputation, Ranking and Objective Measures:

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Reputation,  Rankings and Objective measures

The top-10 heart and heart surgery hospitals (according to US News 2011) were as follows:

  1. Cleveland Clinic
  2. Mayo Clinic
  3. Johns Hopkins
  4. Texas Heart Institute at St Luke’s Episcopal
  5. Massachusetts General
  6. New York Presbyterian University
  7. Duke University Medical Center
  8. Brigham and Women’s Hospital
  9. Ronald Reagan UCLA Medical Center
  10. Hospital of the University of Pennsylvania

(US News, July 19, 2011)

The First shall be First..

Well, the latest US News hospital rankings are out – and as usual, John Hopkins is at the top of the list – as they have been for the last seventeen years.  Or are they on the top of the list because they were ranked #1 for the previous sixteen years?

How much do these or any rankings actually reflect the reality of the health care provided?  What are they really measuring?  These are important questions to consider.  While US News uses these rankings to sell magazines, other people are using these results to plan their medical care.

 So, what do these rankings or studies show[1]?  The answer depends on two things:

1.  Who you ask.  2. The measure(s) used.

Reed Miller, over at Heartwire.com reported the results of a study by Dr. Ashwini Sehgal over at Case Western Reserve examining the US News Rankings back in 2010 (and re-posted below.)  Dr. Sehgal explains that much of what the US News is measuring is not scientific, nor objective data – it’s public opinion, which as we all know, may have little basis in actual facts.  Ask any fifteen-year- old girl who is the most qualified candidate for president – now imagine Justin Bieber in the White House[2].  An extreme example, to be sure – but one that fully illustrates the pitfalls of relying on this sort of subjective data.

News versus Tabloid

This isn’t the first time that the magazine has come under scrutiny for the methodology of their ‘ranking’ practices.  Teasley (1996) exposed similar flaws in their ranking schemes almost fifteen years ago.  Green, Winfield, Krasner & Wells (1997) explained in JAMA that there
were additional limitations to US News approaches due to a lack of availability of standardized data, despite the magazine using what they considered to be a strong conceptual design.  They cite the same concerns with the weight given to reputation as a majority deficiency.

However,  these significant oversights does not prevent the media and hospitals from continuing to present their results as a legitimate measure of  performance. In fact, more people know about these rankings than they do about government data collected for the same purpose.

Core Measures

Compare this well-known ranking, with governmental attempts to quantify and compare American hospitals.  Medicare and Health and Human Services quantifies and ranks hospital  performance using a ‘score card’ scenario known as “Hospital Compare.”

While this government system is far from perfect since it relies heavily on individual physician documentation, it is an evidence-based measurement tool, making it far more objective.  The government rating system uses a series of specific criteria called Core Measures.  These core measures are used to evaluate adherence to accepted treatment strategies for different conditions such as heart failure, heart attack, and pneumonia.  This data is then published on-line for consumers.

The advantages to measurement tools such as Core Measures is that it an easily applied checklist type scoring system.

For example, the core measures used to evaluate the appropriateness of treatment for an acute myocardial infarction (heart attack) are pretty clear cut:

– Amount of time in minutes for patient to receive either cardiac cath or thrombolytic drugs “clot busters”

– How long (minutes) for patient to receive first EKG after presenting with complaints consistent with AMI

– Did patient receive aspirin on arrival?

– Did patient receive ACE/ ARB for LV dysfunction?

– Did patient receive scripts for beta blockers, ACE/ ARB, aspirin at discharge?

As you can see – all of these measurements are clear, easily defined and objective in nature.  The main problem with core measures in many institution is getting doctors to clearly document whether or not they instituted these measures.  (But that too reflects on the institution, so hospitals with multiple staff members not adhering to the national guidelines will have lower scores than other facilities.)  In fact, this is the main criticism of this measurement tool – and this criticism often comes from the very doctors that omit this data.  (In recent years – hospitals have tried to address this shortcoming by making documentation an easier, more streamlined process – and allowing other members of the health care team to participate in this documentation.)

Then this data is compared to other hospitals nationwide, with subsequent percentile ratings, and status.  Ie. a hospital may rank higher or lower than national average for death rate or re-admission for heart attack, pneumonia, post-surgical infection or several other diagnoses/ conditions.  Consumers can also use this database to compare different facilities to each other (such as several hospitals in a local area).

The accessibility and publication of this data for health care consumers is a very real and meaningful public service.  This allows people to make more informed choices about their care, without relying on third-party anecdotes, or reputation alone.

How does this tie in with surgical tourism?  (or what does this have to do with Bogotá Surgery?)

As part of my efforts to provide objective, unbiased information on the institutions, physicians and surgical procedures in Bogotá, Colombia, I applied the Core Measures criteria as part of my evaluation.  I used these measures not on an institutional level, but on an individual provider level – to each and every surgeon that participated in this project.

However, core measures (NSQIP) was not the only tool I used during my assessment.  I also used several other measurements to get a fair/ well-balanced evaluation of the providers listed in my publication.  (Other criteria used  as part of this process will be discussed more fully in a future post.)

Surgical tourism information needs to be clear, objective and meaningful to be of use to potential consumers.  Reputation alone is not sufficient when considering medical treatment either in the United States or abroad – and consumers should seek out this information to help safeguard their health.

Article Re-post from Heartwire.com

Popular best-hospital list tracks subjective reputation, but not quality measures

April 20, 2010 | Reed Miller

Cleveland, OH – US News & World Report‘s list of the top 50 hospitals
in the US reflects the subjective reputations of the institutions and not
objective measures of hospital quality, according to a new analysis [1].

The magazine’s ranking methodology includes results of a survey of 250 board-certified physicians from across the country, plus various objective data such as availability of specific medical technology, whether the hospital is a teaching institution or not, nurse-to-patient ratios, risk-adjusted mortality index based on Medicare claims, and whether the American
Nurses Credentialing Center has designated the center as a nurse magnet.

In his analysis of the US News rankings system, published April 19, 2010 in the Annals of Internal Medicine, Dr Ashwini Sehgal (Case Western Reserve University, Cleveland, OH) points out that previous investigations have compared the US News rankings with external measures and found that highly ranked cardiology hospitals had lower adjusted 30-day mortality among elderly patients with acute MI, but that many of the high-ranked centers scored poorly in providing evidence-based care for patients with MI and heart failure. Also, performance on Medicare’s core measures of MI, congestive heart failure, and community-acquired pneumonia were frequently at odds with US News rankings.

Sehgal sought to examine a broader range of measures internal to the US News system and “found little relationship between rankings and objective quality measures for most
specialties.” He concludes that “users should understand that the relative standings of US News & World Report‘s top 50 hospitals largely indicate national reputation, not objective measures of hospital quality.”

Sehgal performed multiple complementary statistical analyses of the US News & World Report 2009 rankings of the top 50 hospitals in the US, as well as the distribution of reputation scores among 100 randomly selected unranked hospitals.

He examined the association between reputation score and the total score and the connection of objective measures to reputation score. According to Sehgal’s analysis, the statistical association is strong between the total US News score and the reputation score. The association between the total US News score and total objective scores is variable, and there is minimal connection between the reputation score and objective scores.

The majority of rankings based on reputation score alone agreed with US News overall rankings. The top five heart and heart-surgery hospitals based on reputation score alone were the same as those of the US News top five heart hospitals (Cleveland Clinic, Mayo Clinic—Rochester, Johns Hopkins University, Massachusetts General Hospital, and the Texas Heart Institute), and 80% of the 20 heart and heart-surgery hospitals with the best reputation scores were also on the US News top-20 heart and heart-surgery centers.

Objective measures were relatively more influential on cardiology centers’ total scores than in some other categories, but reputation still carried a lot more weight than objective measures. Sehgal used the nonparametric Spearman rank correlation p value to assess the univariate associations among reputation score, total objective-measures score, and total US News score. The p2 value indicates the proportion of variation in ranks of one score that are accounted for by the other score.

Additional Resources and References

1.  Teasley, C. E. III (1996).  Where’s the best medicine? The hospital rating game. Eval Rev. 1996 Oct;20(5):568-79.

2. Green J,  Wintfeld  N., Krasner M.  & Wells C.  (1997).  In search of America’s best
hospitals. The promise and reality of quality assessment. JAMA. 1997 Apr 9;277(14):1152-5.

3. Sehgal, A. R. (2010). The role of reputation in U.S. News & World Report’s rankings of the top 50 American hospitals. Ann  Intern Med. 2010 Apr 20;152(8):521-5.

[1] US News may be the best known, and most widely published source, but there are multiple
studies and reports attempting to rank facilities and services nationwide.

[2] This is probably not a fair analysis given the current state of American politics.

Lifestyle Modification after Bariatric Surgery

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Lifestyle modification after bariatric surgery is one of the cornerstones for successful and sustained weight loss, and healthy living.  However, the majority of emphasis is placed on dietary changes – as a result of the surgical alterations to stomach capacity.  While dietary modification for healthy eating (energy intake) is extremely important – we are also going to talk about the other part of the equation for both weight loss and healthy living: Exercise (energy expenditure).

Exercise and physical fitness are critical for multiple reasons – beyond initial weight loss, but many people often question the ability of the morbidly obese to exercise vigorously (and safely).  A new study by Shah et. al (June 2011) in Obesity magazine examines this concept.  Shah and his team of researchers divided gastric bypass patients and gastric banding patients into two groups ;  a control group receiving standard therapy and a high intensity exercise group.  The findings confirmed that physical fitness is both possible and beneficial for these patients.

Since both the original article and several articles discussing these finds are paid/ subscription sites, I have re-posted from Medscape (which is more freely accessible for most people.)

For more articles on Bariatric Surgery, see the sidebar for our archives.

Rigorous Exercise May be Feasible after Bariatric Surgery

– Laurie Barclay (Medscape)

July 15, 2011 — Rigorous exercise may be feasible and beneficial to maintain weight after bariatric surgery, according to the results of a randomized controlled trial reported online July 7 in Obesity.

“[W]e didn’t know until now whether morbidly obese bariatric surgery patients could physically meet this goal,” said senior author Abhimanyu Garg, chief of nutrition and metabolic diseases at University of Texas Southwestern Medical Center at Dallas, in a news release. “Our study shows that most bariatric surgery patients can perform large amounts of exercise and improve their physical fitness levels. By the end of the 12 weeks, more than half the study participants were able to burn an additional 2,000 calories a week through exercise and 82 percent surpassed the 1,500-calorie mark.”

The investigators studied the tolerability and efficacy of high-volume exercise program (HVEP) in 33 obese, postbariatric-surgery patients who had undergone Roux-en-Y gastric bypass and gastric banding. Mean body mass index (BMI) was 41 ± 6 kg/m2. Participants were assigned for 12 weeks to an HVEP (n = 21) or to a control group (n = 12). All participants were advised to limit energy intake, and the HVEP group was also counseled to take part in moderate-intensity exercise resulting in energy expenditure of at least 2000 kcal/week. Repeated measures analysis allowed determination of treatment effect.

In the HVEP group, more than half (53%) of participants expended at least 2000 kcal/week during the last 4 weeks of the study, and 82% expended at least 1500 kcal/week. Compared with the control group, the HVEP group had significant improvement at 12 weeks in step count, reported time spent and energy expended during moderate physical activity, maximal oxygen consumption relative to weight, and incremental area under the postprandial blood glucose curve (group-by-week effect: P = .009 – .03).

“We found that participants in the exercise group increased their daily step count from about 4,500 to nearly 10,000 so we know that they weren’t reducing their physical activity levels at other times of the day,” Dr. Garg said. “We also found that while all participants lost an average of 10 pounds, those in the exercise group became more aerobically fit.”

Some quality-of-life scales improved significantly in both groups. The groups did not differ significantly in changes in weight, energy and macronutrient intake, resting energy expenditure, fasting lipids and glucose, and fasting and postprandial insulin concentrations.

“HVEP is feasible in about 50% of the patients and enhances physical fitness and reduces postprandial blood glucose in bariatric surgery patients,” the study authors write.

Limitations of this study include short duration, small sample size, dropout rate higher in the control group vs the HVEP group, dietary and exercise counseling provided at an individual level and not at the group level, and use of an unsealed pedometer to measure physical activity.

“Whether a HVEP helps to maintain weight loss and improvement in comorbidities in these patients remains to be evaluated in long-term studies,” the study authors conclude. “The studies also need to assess how exercise over the long-term effects factors that influence energy balance including energy intake, nonexercise activity levels, body composition, metabolic rate, and gastrointestinal hormones related to satiety and hunger.” [end of article].

Interestingly, the exercise group did not lose more weight than the control group – but as many people know – exercise and physical fitness are important for more than just weight maintainance.

Aerobic exercise, in particular is important for cardiovascular health.  Physical activity is also important for bone and muscle strength and general performance status and maintenance of activities of daily living (ADLs).  All of these contribute to the overall quality of life for individuals.

Independent Authors & Writers

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Excited to report that I have received “Book of the Day” on Independent Authors & Writers.org. You can check out their facebook site here.

I’ve also added a link to their blog, here at WordPress.

As many of my long-time readers know, it’s very difficult to get books like this published by commercial publishing houses – since it’s considered a ‘niche’ title with limited marketing potential.  Of course, I hope to prove them wrong but I am grateful to organizations like the Independent Authors for giving unknowns like myself a chance to be discovered by the reading public.

For all my Colombian readers, I am bringing copies down to Bogotá next month – they will be available at Authors Cafe – Calle 70, No. 5- 23.  (Otherwise, it’s about 30 dollars to have a copy of the book shipped from the US.)

Final drafts.

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Looks like I am getting closer to the finish line; I submitted what is (hopefully) the last and final draft last week.  After one last round of review – it will be off to the publisher.. (This is the most frustrating part of the process – it’s all formatting issues – unrelated to content.)

Otherwise – the book looks pretty darn good!

Proof copies!

Proof copies!!

 

 

Peri-operative mortality with/after TAVI for aortic stenosis

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More on TAVI: A newly published analysis of the existing/ reported data for peri-operative mortality after transcatheter aortic valve implantation looking at 12 previous studies was recently (June) published in the journal of Interventional Cardiology.  (While the study looks at the causes of death – we here at Cartagena Surgery – are going to talk about the rate of death in this study.)

Article information:

Causes of Peri-Operative Mortality After Transcatheter Aortic Valve Implantation: A Pooled Analysis of 12 Studies and 1,223 Patients.  The Journal of Invasive Cardiology 2011;23(5):180-184.

Raul Moreno, MD; Luis Calvo, MD; Pablo Salinas, MD; David Dobarro, MD; Jimenez Valero Santiago, MD; Angel Sanchez-Recalde, MD; Guillermo Galeote, MD; Luis Riera, MD; Isidro Moreno-Gomez, MD; Jose Mesa, MD; Ignacio Plaza, MD; Jose Lopez-Sendon, MD

Abstract re-posted below.

Background. In order to improve technique and to prevent serious procedural complications during transcatheter aortic valve implantation (TAVI), it is crucial to identify the causes of death of patients undergoing this procedure.
Objective. The objective of this study was to identify the causes of death during the procedure and at 1 month in patients with severe aortic stenosis undergoing TAVI.

Methods. 12 published studies with information about the causes of death in patients undergoing TAVI were selected. Overall, 1,223 patients were included in these studies, and 249 deaths were reported (119 at 1 month and 130 at > 1 month post-procedure).

Mortality during the procedure and at 1 month was 2.3% and 9.7%, respectively. The proportion of cardiac deaths was higher at < 1 month in comparison with > 1 month (56% versus 34%, respectively; p = 0.001). At 1 month, the most frequent causes of death were cardiac failure/multi-organ failure (24%), sudden death/cardiac arrest (17%), vascular and bleeding complications (17%), stroke (11%), sepsis (11%), and cardiac tamponade (10%). During the procedure, the most frequent causes of death were cardiac tamponade (39%), cardiac failure (21%), cardiac arrest (18%), and vascular and/or bleeding complications (18%).

In patients treated with the CoreValve system (Medtronic, Minneapolis, Minnesota) versus those treated with Edwards valves (Cribier-Edwards, Edwards-SAPIEN or SAPIEN XT valve, Edward Lifesciences, Irvine, California), deaths at 1 month due to vascular and bleeding complications were less frequent (3% versus 22%, respectively; p = 0.019), but those due to cardiac tamponade (26% versus 6%, respectively; p = 0.019), and because of aortic regurgitation (10% versus 0%, respectively; p = 0.03) were more frequent.

Conclusion. In this pooled analysis, mortality at 1 month after TAVI was 9.7%. The causes of death were widely variable, and of both cardiac and non-cardiac origin. There were some important differences between both devices in the cause of mortality.

How does this compare with conventional aortic valve replacement surgery (AVR)?

In cardiac surgery – surgeons use database calculators.  The most popular one is called the STS risk calculator to determine or estimate the surgical risk for specific patients.  This calculator is based on thousands and thousands of patients over decades of research to give approximate surgical risk of morbidity (post-operative complications) and mortality by looking at the planned procedure as well as patient risk factors (age, poor heart function, co-morbidities).  Other calculators include a European calculator called EUROscore, and a score used  by the VA (veteran’s hospitals.)

Well, how accurate are these calculators?

Interestingly enough – at the same time as the TAVI article, an article (Basreon et. al) discussing and comparing each of these calculators to actual results was published in the June 23 issue of the Annals of Thoracic Surgery.  (I’ve re-posted the abstract below.)

In their research – Basreon et. al. found the overall peri-operative mortality for aortic valve replacement surgery to be 5.9%  which is well under the 9.7% reported in the article by Moreno, et. al (re-posted above) for TAVI.

While the argument can be made that the higher than expected peri-operative mortality in the TAVI group may be secondary to other factors (patient condition at time of TAVI) without more information on patient demographics – it is hard to know.

I, for one, would like to know the average ages of patients in both groups – was the TAVI group made up of non-surgical fragile, 95 year-olds?  What specific factors raised their EUROscores? Was it overall heart function, or was it a specific co-morbidity?

It’s difficult to know since it’s a composite of other research data from multiple studies (and since TAVI is widely used in Europe, accounting for as many as 40% of all aortic procedures in Germany, for example) – this data may also reflect many of these patients (who are not frail elderly, for example.)

Reading through the Moreno study – there is little discussion of the actual patient population, except for one small paragraph (re-posted below). Both of these limitations are probably due to the nature of the study – where investigators were pooling the results of several different studies – which is a good strategy to get a wide overview.  However, this can make it impossible to go back and look at questions like ours, particularly if the investigators on the original, smaller studies didn’t record / report this information.

[my comments in brackets/ italics].  I have placed data within the article in bold or italics. 

“In this study, pooling the results of 12 series, mortality at 1 month in patients treated with TAVI was 9.7%, and mortality during the procedure was 2.3%. These data compare favorably with the predicted surgical mortality, since EuroSCOREs ranged from 12–28%.  [this is the risk calculator that Basreon et. al found that grossly overestimated risk in the study re-posted below.]

In the randomized PARTNER trial, a significant reduction (~20% absolute risk reduction) in the 1-year mortality was obtained for patients with severe aortic stenosis and considered not suitable for surgery due to a very high surgical risk when treated with TAVI in comparison with medical treatment. [as you know from previous discussions – medical treatment is exceedingly ineffective for this condition.  It would be more helpful if authors had better defined their ‘very high’ risk patient group since multiple studies show that cardiologists, etc. overestimate patient’s surgical risk.] 

Importantly, mortality significantly reduced through the years, from 2004 to 2010, probably reflecting not only the learning curve and the technical improvements, but also a better patient selection process. [meaning patients that are ineligible for surgery may also be ineligible for TAVI in some cases.]   This reduction in mortality over time has also been observed in single-center experiences.“

Although not statistically significant, mortality at 30 days was higher in patients treated by transapical approach in comparison with transfemoral approach. Probably, the worse clinical profile of patients undergoing transapical TAVI justifies, at least in part, these findings.[7,12]

Ann Thorac Surg. 2011 Jun 23. [Epub ahead of print] Comparison of Risk Scores to Estimate Perioperative Mortality in Aortic Valve Replacement Surgery.

Source

Division of Cardiology, Veterans Administration Medical Center and University of Minnesota, Minneapolis, Minnesota.

Abstract  (bolding/ italics from original article)

BACKGROUND:

Transaortic valve implantation has recently been introduced as an alternative to aortic valve replacement (AVR) for high-risk patients with aortic stenosis. However, accurate assessment of surgical risk is critical for appropriate patient selection. We compared the accuracy of The Society of Thoracic Surgeons (STS) risk score, the European System for Cardiac Risk Evaluation (EuroSCORE), and the Veterans Administration (VA) risk score in predicting perioperative mortality after AVR.

METHODS:

We included 537 consecutive patients who underwent AVR for severe aortic stenosis at the Minneapolis VA Medical Center between 1997 and 2008. Observed and predicted perioperative (30-day) mortality rates were compared. Hosmer-Lemeshow goodness-of-fit test and receiver operating characteristic curves were performed to assess the performance of the scores.

RESULTS:

Perioperative mortality rate was 5.9% (n = 32). Predicted mortality rates for the EuroSCORE, STS score, and VA score were 15.6%, 3.6%, and 6.7%, respectively (p = 0.001). The EuroSCORE overestimated mortality in all patients, most notably among those with ejection fraction less than 35% (49% predicted versus 9% observed). The EuroSCORE had poor calibration (goodness-of-fit test p < 0.008), whereas the STS and the VA scores were well calibrated. However, all three scores displayed good discrimination characteristics per the areas under the receiver operating characteristic curves: STS score 0.73 (95% confidence interval: 0.69 to 0.77); VA score 0.66 (95% confidence interval: 0.62 to 0.70); and EuroSCORE 0.68 (95% confidence interval: 0.64 to 0.72; p > 0.05).

CONCLUSIONS:

The EuroSCORE substantially overestimates perioperative mortality risk in AVR, particularly in patients with low ejection fraction. These data have implications when deciding the appropriate intervention (transaortic valve implantation versus AVR) for high-risk aortic stenosis patients.

In general – the majority of the literature cites peri-operative mortality for AVR at 2.0 – 5.0% (but this is an average of ALL patients, making the calculators our best estimate of predicted risk.)

So what does this mean?

Clearly, when the data from Moreno et. al shows a thirty-day (peri-operative) mortality of almost 1 in 10 patients – it’s a signal we need to proceed with caution, and continue to follow the research.

1.  Since the authors report many of these patients at very high surgical risk (presumably due to cardiac status as well as co-morbidities) and 2. we know that in most people aortic stenosis progresses slowly  – it stands to reason that we need to consider intervening earlier in the course of the disease.  (Before the heart is significantly weakened).

For people with Aortic Stenosis – I’d want to get second/ third opinions from a cardiac surgeon before proceeding with any catheter based valve procedures.  I’d bring all of my information, and studies (echocardiogram results, lab results, medication lists) to have a serious talk to the surgeon about my surgical risk – (and ask him to calculate and show my risk based on the STS calculator).  I certainly wouldn’t let anyone make any decisions about my health/ care based on my age alone.  [we’ve talked about a ‘good 80’ versus a ‘bad 80’ or even a ‘bad 50’ before.]

Then, I would weigh all of the information – and do my best to make an informed decision.

Other posts about Aortic Stenosis/ TAVI/ AVR:

1. TAVI overview

2. TAVI: a stent scenario

3. TAVI recommendations

4. Aortic Stenosis and TAVI

5. Aortic Stenosis as Heinz 57

6. Aortic stenosis and surgery

What is an Acute Care NP? a review of the literature surrounding the role, function and patient satisfaction

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One of the questions I field frequently in both practice and here at Cartagena surgery is – What is an acute care nurse practitioner (ACNP)?  This is usually bracketed by statements such as, “I didn’t know NPs could work in surgery.  I thought you only worked in [primary care] clinics.”  Sometimes it’s patients asking the questions – sometimes it’s the surgeons themselves.

This is usually followed by questions or statement about whether ACNPs belong in this role, and if we function at a ‘satisfactory level’ in acute care settings such as intensive care units, emergency departments and specialty surgery practices.

The answer lies in the research, and the overwhelming majority of the literature states that we do, in fact, function very well, in our role to augment  (not replace) physician services.  We do so well, in fact, that the most recent literature is primarily focused on surgeons in other countries and their efforts to import the NP models to their countries (Japan, the UK specifically) over the last few years.

But I don’t expect readers to take my word for it.  Hopefully by now, you’ve all become informed consumers – so I’ve posted some references with links below.  In many cases the entire article was not available [without subscription] so in those cases, particularly long articles – I’ve posted a link to the abstract.  In some cases, there is no abstract available on-line so I’ve included the citation.

Unfortunately many of the larger studies on patient satisfaction are based in the primary care setting, so I have omitted them.

Since I’ve gotten quite a bit of interest on this topic from medical providers, other nurses and readers – I’ve added a section for literature relating to nurse practitioners, which I will try to update periodically, since it is too large of a project for a single post.

Nurse Practitioners in Surgical Specialties/ Acute Care Settings: Review of the available literature

1. The role, productivity, and patient satisfaction of surgical nurse practitioners compared to medical surgeons at VA outpatient clinics.  Palmquist, D. (2010).  Graduate dissertation at Tui University.  This is actually a head to head comparison of NPs to MDs which showed greater productivity by MDs (saw more patients) but greater patient satisfaction with care by NPs. [abstract only].  This isn’t surprising in that surgeons have an enormous amount of responsibilities and demands placed on their time.

2. Patient satisfaction with a nurse practitioner in a university emergency service. Rhyee, K & Dermyer, A. (1995). Annals of Emergency Medicine, Volume 26, Issue 2 , Pages 130-132, August 1995.    Study showed no difference between patient satisfaction with care by either MD or NP. Notably, the primary author was a physician [abstract only].

3. Acute care pediatric nurse practitioner: a vital role in pediatric cardiothoracic surgery.  Okuhara CA, Faire PM, Pike NA.  J Pediatr Nurs. 2011 Apr;26(2):137-42  [abstract only].  These NPs are actually dually certified in most cases – in pediatrics and acute care.

4.  The effect of a multidisciplinary hospitalist/physician and advanced practice nurse collaboration on hospital costs.  Cowan MJ, Shapiro M, Hays RD, Afifi A, Vazirani S, Ward CR, Ettner SL.  J Nurs Adm. 2006 Feb;36(2):79-85.  Reduced length of stay, reduced patient costs, and hospital costs on teams with nurse practitioners.

5. The evolving role of the acute care nurse practitioner in critical care.  Howie-Esquivel J, Fontaine DK.  Curr Opin Crit Care. 2006 Dec;12(6):609-13. A nice article that talks about how the NP role is expanding internationally to copy American health care models.

6. The advanced practice nurse in an acute care setting. The nurse practitioner in adult cardiac surgery care.  Callahan M.  Nurs Clin North Am. 1996 Sep;31(3):487-93.  [abstract only].  This article was actually written by researchers at my alma mater, Vanderbilt.

7.  Outcomes of tube thoracostomies performed by advanced practice providers vs trauma surgeons.  Bevis LC, Berg-Copas GM, Thomas BW, Vasquez DG, Wetta-Hall R, Brake D, Lucas E, Toumeh K, Harrison P.  Am J Crit Care. 2008 Jul;17(4):357-63. [full text article].  This is a nice study that actually compares NP/ MDs performing invasive procedures – in this case, chest tube placement.

8. Effect of an outcomes-managed approach to care of neuroscience patients by acute care nurse practitioners.  Russell D, VorderBruegge M, Burns SM.  Am J Crit Care. 2002 Jul;11(4):353-62. [full text article].  This article is one of a series of articles published by researchers at UVA which led the changes in the University of Virginia policy – (the results were so compelling that UVA)  to advocate for exclusive use of nurse practitioners in all acute care areas.  It showed shorter length of stays, less infections for patients care for by NPs versus residents.

Several Japanese researchers are looking at the role of nurse practitioners, as mentioned above.

1.  Nurse practitioners in surgical services in the United States.  Okano A.  Nippon Geka Gakkai Zasshi. 2011 May;112(3):207-10. Japanese.  No abstract available.

2.  Considering the feasibility of introducing nurse practitioners into Japanese thoracic services.  Komatsu T, Coutler L, Henteleff H, Johnston M, Bethune D. Ann Thorac Cardiovasc Surg. 2010 Aug;16(4):303-4  [full text article].  An interesting article, written by Canadians, who have just started to recognize NPs in the acute care/ surgical settings.The comments from the surgeons at the Canadian facility are quite interesting as well.   I wouldn’t mind helping the thoracic surgeons in Japan get used to ACNPs..  🙂

3.   [Surgeons’ hope: expanding the professional role of co-medical staff and introducing the nurse practitioner/physician assistant and team approach to the healthcare system].  [Article in Japanese]  Maehara T, Nishida H, Watanabe T, Tominaga R, Tabayashi K. Nippon Geka Gakkai Zasshi. 2010  Jul;111(4):209-15.

Summary: The healthcare system surrounding surgeons is collapsing due to Japan’s policy of limiting health expenditure,market fundamentalism, shortage of healthcare providers, unfavorable working environment for surgeons, increasing risk of malpractice suits, and decreasing number of those who desire to pursue the surgery specialty. In the USA,
nonphysician and mid-level clinicians such as nurse practitioners (NPs) and physician assistants (PAs) have been working since the 1960s, and the team approach to medicine which benefits patients is functioning well. One strategy to avoid the collapse of the Japanese surgical healthcare system is introducing the NP/PA system. The division of labor in medicine can provide high-quality, safe healthcare and increase the confidence of the public by contributing to: reduced postoperative complications; increased patient satisfaction; decreased
length of postoperative hospital stay: and economic benefits. We have requested that the Ministry of Health, Labor and Welfare establish a Japanese NP/PA system to care for patients more efficiently perioperatively. The ministry has decided to launch a trial profession called “tokutei (specifically qualified) nurse” in February 2010. These nurses will be trained and
educated at the Master’s degree level and allowed to practice several predetermined skill sets under physician supervision. We hope that all healthcare providers will assist in transforming the tokutei nurse system into a Japanese NP/PA system.

Note: This is also ground-breaking, as other countries have been slow to implement nurse practitioners in any areas of their medical care system.  The fact that this is a surgical setting is  even more encouraging. These researchers have also published research on the introduction of NPs in other surgical specialties.

NPs and Residents: a delicate balancing act

In fact, nurse practitioners are the reason that recent changes (July 2011) in surgical/ medicine residency hours are even possible. Without the services that NPs provide, it would be impossible for large teaching institutions to implement the new mandated resident hour restrictions.

Even before the newest restrictions – nurse practitioners have been called to take up the slack (when resident hours were previously reduced both here and in Canada.)  However, it was these restrictions that gave us our greatest opportunities for larger acceptance in the acute care specialties.  (Nurse practitioners have worked in acute care since our inception but were not widely known in this acute care role.)  Fortunately, the data shows that not only have NPs made up for the lack of residents, we’ve actually improved the level of care and patient satisfaction [in comparison to care given by residents].

More information of resident hour restrictions

Next time – I’ll include several more articles, including some more looking at my own specialty – cardiothoracic surgery.

Transcatheter Valve Therapy – (TAVI) overview

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Here’s some follow-up information on the current recommendations / guidelines from the ACC (cardiologists) and STS (cardiac surgeons) on the use of TAVI or catheter-based therapies for the treatment of valvular disease.

Read it for yourself and let me know what you think, but I find it to be a nice, concisely worded document that clearly delineates and spells out the current role of TAVI therapies as a limited therapy for specific populations – at least until we have long-term outcome data.  (We can look to Europe and observe their outcomes, in part).

Not for young people, not for people who could withstand surgery (as determined by a surgeon/ sts risk calculator).  Not as part of an ‘easy fix’ mentality that winds up slapping us (and the patient) in the face a few years later.

Let’s hope that all the interventionists keep to the fundamental principles outlined here, as part of our commitment to patient care, safety and well-being.

Re-posted from Cardiosource.com

Title:         Transcatheter Valve Therapy: A Professional Society Overview From the American College of Cardiology Foundation and the Society of Thoracic Surgeons
        Date Posted:         June 27, 2011
        Authors:         Holmes DR Jr, Mack MJ.
        Citation: J Am Coll Cardiol 2011;Jun 27:[Epub ahead of print].
 Perspective:

The following are 10 points to remember about this expert consensus document on transcatheter valve therapy:

1. Transcatheter valve therapy is a transformational technology with the potential to significantly impact the clinical management of patients with valvular heart disease.

2. Although the initial experience is positive, evidence exists from only one randomized clinical trial in patients with aortic stenosis and one in patients with mitral insufficiency.

3. Adoption of these techniques to populations beyond those studied in these randomized trials, therefore, is not appropriate at the current time.

4. It will be important to establish regional centers of excellence for heart valve diseases. Criteria for centers performing interventional therapy in valvular and structural heart disease should be established, and the availability of devices and reimbursement for those procedures should be limited to those centers meeting those criteria.

5. The heart team approach should be used with formation of multidisciplinary heart teams within these centers led by primary cardiologists, cardiac surgeons, and interventional cardiologists.

6. Performance of isolated procedures without construction of a dedicated valve therapy program to encompass all aspects of care—including preprocedural assessment in common clinics, joint procedure performance, and common patient care pathways—is not recommended.

7. A national registry of valvular heart disease to perform post-market surveillance, long-term outcome measurement, and comparative effectiveness research should be established. This could be accomplished by linking the ACC’s NCDR® and STS clinical databases to the Social Security Death Master file and Centers for Medicare & Medicaid Services administrative databases in a national ‘research engine.’ This will, in effect, create a national registry of valvular heart disease.

8. Training and credentialing criteria for practitioners in this field need to be developed. Development of criteria for the formation of fellowship programs, as well as postgraduate training with appropriate experience for adequate patient care leading to guidelines for credentialing, is currently underway by multiple professional societies working together.

9. Interpretation of the current evidence by expert consensus documents and appropriate use criteria need to be developed.

10. With society leadership, multidisciplinary partnerships, and cooperation, a reasoned, balanced introduction of this new therapy can be accomplished.

Single incision laparoscopy revisited

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A new abstract published [ and re-posted below] in advance of the article – confirms what Bogotá surgeons already know –

Uniport or single incision laparoscopy is a safe, effective surgical treatment which reduces post-operative pain, length of stay and recovery time for patients while providing better cosmetic outcomes.

Surprising to me, it seems there is still hesitation among surgeons in the United States to adopt this technique for routine procedures such as appendectomy, or cholecystectomy.  In fact, during a recent multi-day tour of Duke University – I was unable to find out information/ or confirm the use of this technique by a single surgeon in the facility.  [My methods were by no means definitive or scientific – I questioned surgeons and anesthesiologists but it’s possible that surgeons using this technique were not identified.  However, the majority of people I spoke to didn’t know what SIL was, and required a description of the procedure, which adds to my suspicions that this procedure is not being performed at Duke.   I will be back at Duke later this month, and will continue to investigate.]  if true, this is a significant finding, and failure in American surgery – Duke is one of the leaders in surgical innovation and emerging therapies.

Now the abtract below talks about increased surgical time – which is true, initially as surgeons learn the technique.  However, as surgeons become more experienced in this procedure, this is no longer the case. In the cases I observed in Colombia, there was no increase in surgery time – but the surgeon has been performing this technique for several years.

Correction:  Despite what I was initially informed – Duke general surgeons do use SILS, and use the single incision laparoscopy approach as part of their living donor kidney transplantation.    I apologize for the error. 

Abstract re-posted below:

 Single incision laparoscopic cholecystectomy (SILC) versus laparoscopic cholecystectomy (LC) – a matched pair analysis

Source

Department of Surgery, Krankenhaus der Elisabethinen, Fadingerstrasse 1, 4020, Linz, Austria, odogangl@yahoo.com.

Abstract

INTRODUCTION:

The aim of our study was to compare single incision laparoscopic cholecystectomy (SILC) and laparoscopic cholecystectomy (LC) with respect to complications, operating time, postoperative pain, use of analgesics, length of stay, return to work, rate of incisional hernia, and cosmetic outcome.

METHODS:

Sixty-seven patients underwent SILC. Of a cohort of 163 LC operated in the same time period, 67 patients were chosen for a matched pair analysis. Pairs were matched for age, gender, ASA, BMI, acuity, and previous abdominal surgery. In the SILC group, patient characteristics (gender, age, BMI, comorbidities, ASA, previous abdominal surgery, symptomatic cholecystolithiasis, cholecystitis) and perioperative data (surgeon, operation time, conversion rate and cause, intraoperative complications, postoperative complications, reoperation rate, VAS at 24 h, VAS at 48 h, use of analgesics according to WHO class, and length of stay) were collected prospectively.

RESULTS:

Follow-up in the SILC and LC group was completed with a minimum of 17 and a maximum of 26 months; data acquired were recovery time the patients needed until they were able to get back into the working process, long-term incidence of postoperative hernias, and satisfaction with cosmetic outcome. Operating time was longer for SILC (median 75 min, range 39-168 vs. 63, range 23-164, p = 0.039). There were no significant differences for SILC and LC with regard to postoperative pain measured by VAS at 24 h (median 3, range 0-8 vs. 2, range 0-8, p = 0.224), at 48 h (median 2, range 0-6 vs. 2, range 0-8, p = 0.571), use of analgesics, and length of stay (median 2 days, range 1-9 vs. 2, range 1-11, p = 0.098). There was no major complication in either group. The completion rate of SILC was 85.1% (57 of 67). Although there was a trend towards an earlier return to the working process in patients of the SILC group, this was not significant. The rate of incisional hernias was 1.9% (1/53) in the SILC and 2.1% (1/48) in the LC group indicating no significant difference. Self-assessment of satisfaction with the cosmetic outcome was not judged different by patients in both groups.

CONCLUSION:

SILC is associated with longer operating time, but equals LC with respect to safety, postoperative pain, use of analgesics, length of stay, return to work, rate of incisional hernia, and cosmetic outcome.

Langenbecks Arch Surg. 2011 Jun 22. [Epub ahead of print]

Sleep Apnea in Bariatric Surgery patients: pre-operative evaluation

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A new study (re-posted below) found that more than 85% of bariatric patients who had pre-operative evaluation before bariatric surgery had significant obstructive sleep apnea.  While the study was small (less than 400 patients), the findings of this study suggest two things:

1.  An evaluation for sleep apnea should be part of routine pre-operative evaluation but ALSO –

given the very high rates of sleep apnea with increasing BMI – and the increased risks of heart attack, pulmonary hypertension and other serious,  life-threatening consequences of untreated sleep apnea –

2.  Increase screening for obstructive sleep apnea in ALL obese patients. (during routine evaluations, and as part of pre-operative evaluation before any surgery requiring general anesthesia.)  [note: #2 is my personal recommendation – not the recommendation of the researchers presenting at this conference.  But as you’ll note below – the preliminary screening questionaire can be done relatively easily, and given the value of findings – additional testing is reasonable even in patients with negative responses to the questionaire.

Due to the strong link between apnea and cardiac events – in our practice, we screened each patient using a series of questions to both the patient and the patient’s significant other (after obtaining patient permission).

To the patient:  Do you snore?  Have you ever been told you snore?  Do you wake up tired, or feel sleepy during the day?

To significant other:  Does the patient snore?  Do you ever hear long pauses between breathing / snoring while the patient is sleeping? Do you ever think that he/she has stopped breathing?

(Then depending on circumstance, in-patient / out-patient – patients were informally screened using pulse oxymetry either in the cath lab or in the intensive care unit.)  This means – we had nurses monitor the patients during sleep:

– Noting each and every time the patient’s oxygen saturation dropped below 92%

– Alterations in heart rate

– Presence of absence of apnea sleeping patterns, snoring etc.

Since our patients were already in the hospital under nursing care (in either the cath lab, or hospital room) the nurses were able to do this easily as part of routine assessment, and monitoring, and there was no extra cost to our patients.

In our case, this information was used for post-surgical management.  After extubation, patients*  were frequently placed on bipap for several hours to reduce atelectasis, and reintubation.  In our at-risk patients, bipap was instituted as part of the sleep routine during their in-patient stay, with a pulmonary medicine referral, and evaluation for home CPAP therapy.  In this way, we were able to avoid expensive/ and time-consuming tests prior to surgery, and still effectively treat our patients. to determine the predictive value of having a spouse tell us, “sometimes I can’t sleep because I am worried he won’t start breathing again” as we’ve heard on multiple occasions.

In our experience, the significant other was best able to provide important diagnostic information.  Unfortunately, we haven’t recorded these findings as part of a research study

* this therapy was used independent of apnea status

Article Re-post: Presentation of a recent abstract at the American Society of Metabolic and Bariatric Surgery in Orlando, Florida

Sleep Test Needed Before Bariatric Surgery

-Charles Bankhead, reporter

ORLANDO  —  Most candidates for bariatric surgery have obstructive sleep apnea (OSA), making a case for polysomnography as a part of the preoperative evaluation of every patient, investigators concluded.
Of 359 patients who had preoperative polysomnography, 86% had positive tests, which showed severe OSA in half of the cases.

The patients had a high prevalence of the sleep disorder across the range of body mass index (BMI) values represented by the patient population, although every patient in the highest BMI category (≥60) tested positive for OSA, as reported here at the American Society of Metabolic and Bariatric Surgery meeting.

“Some people think that only patients in the highest BMI categories should be referred for polysomnography, because they are the patients who are most likely to have obstructive sleep apnea,” Abdul S. Bangura, MD, of Staten Island University Hospital in New York, told MedPage Today.

ActivateCME
 Points to remember

  • Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
  • Explain that most candidates for bariatric surgery have obstructive sleep apnea (OSA), making a case for polysomnography as a routine part of the preoperative evaluation of every patient.
  • Note that every patient in the highest BMI category (≥60) had a polysomnographic test showing sleep apnea.

“However, our study showed a high prevalence of obstructive sleep apnea in all BMI categories. Because of that, we think polysomnography is justified during the preoperative evaluation of all bariatric surgery patients, and that is the policy at our institution.”

Obesity substantially increases the risk of OSA, and studies have documented a high prevalence of OSA and other sleep-related breathing disorders among patients evaluated for bariatric surgery. Polysomnography remains the gold standard for diagnosis and assessment of OSA, but practices vary with regard to use of the sleep test in the preoperative evaluation of candidates for weight-loss surgery, said Bangura.

Moreover, patients and physicians alike find sleep tests inconvenient, time-consuming, and expensive, he continued.

At his own center, polysomnography is a routine component of the preoperative workup. However, other centers have adopted a selective approach to use of the sleep test, relying on the level of clinical suspicion of OSA to guide decision making.

“Various scoring systems have been used to screen for sleep apnea, but all of them remain controversial,” said Bangura. “There is currently no standard protocol for screening obese patients for OSA.”

To see whether a routine or selective approach to preoperative testing for OSA is more appropriate, Bangura and colleagues retrospectively reviewed records of all patients who had bariatric surgery procedures at their center from 2005 to 2010. They identified 555 patients, including 359 (65%) who underwent polysomnographic evaluations during their preoperative workup.

Investigators used the apnea/hypopnea index (AHI) to categorize apnea severity, defining mild OSA as an AHI score of 5 to 15 events per hour; moderate as a score of 15 to 30; and severe as a score exceeding 30.

Of the 359 patients evaluated for OSA, 309 (86%) had positive tests, including some patients who had positive OSA tests prior to the preoperative evaluation for bariatric surgery. On the basis of AHI scores, 18% of the 359 patients had mild OSA, 17% had moderate OSA, and 51% had severe apnea.

Analysis of OSA prevalence by preoperative BMI showed that the following tested positive for OSA:

  • 34 of 37 (92%) patients with BMI values of 35 to 39.9
  • 178 of 218 (82%) of patients with BMI values of 40 to 49.9
  • 78 of 85 (92%) of patients with BMI values of 50 to 59.9
  • 100% of patients with BMI values of 60 or greater

“Based on these results, we consider routine polysomnography to be an essential part of the preoperative workup for all bariatric patients,” Bangura and colleagues concluded in their poster presentation.

Randomized controlled trials are required to provide evidence of guidelines on routine use of polysomnography as part of the workup for bariatric surgery patients, he said. Given the lack of a reliable prognostic system to predict OSA, the investigators urged consideration of routine polysomnography as part of the preoperative evaluation of all bariatric surgery candidates.

Aortic Stenosis and TAVI therapies: new recommendations

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Durham, North Carolina : After a recent visit to the west coast to interview a cardiac surgeon, I am back on the east coast – spending the week down here in Durham to interview the lung transplant surgeons at Duke.  I’ll be talking about it over at the thoracic surgery portal in a series of articles.

As we brushed on in a previous article, TAVI (transcutaneous aortic valve intervention) is the newest interventional therapy on the block, per se and is garnering a lot of media and medical attention.  One of the biggest concerns from a health care providers’ standpoint – is that we use this therapy appropriately – in the right patients, for maximum benefits.

One of the good side effects of all this media attention is that the undertreatment of aortic stenosis by medical doctors is now being addressed.

Another article – this one from Medpage.com talks about the potential impact of the commercial approval of TAVI in the US.  (Currently it has only been used in the United States as an investigational therapy – meaning that fairly strict criteria have been used in patient selection.)  Once it’s available commercially, physicians can use it at their own discretion, which is what the American College of Cardiology (ACC) and the Society of Thoracic Surgeons (STS) is attempting to address with these statements.  (Like any commercially available product or service, there will be some doctors who will adopt the practice sooner than others and some doctors who will offer it to patients more readily (and even in cases where appropriateness may not have been determined.)

Diabetes – a global epidemic

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New estimates on the rates of diabetes worldwide were reported in the general media this week.  As frightening as these numbers are – 36 million people in the USA, and over 348 million worldwide, I still think these numbers fall short of the mark.  This truly is a global pandemic, and as against federal ‘big brother’ regulations (and pro-personal freedoms) as I am – I do think that it has come to a critical point where the governments of these nations (ours included) need to step in.  We need to go against the big business of soft drinks, and the fast food giants to save our nation, and save ourselves from the heavy toll of obesity related disease.

Obviously, all the educational efforts and promotional campaigns to encourage healthy eating and activity are falling on deaf ears.  Much of the media attention is devoted to the plight of the poor with limited access to healthy habits such as safe areas to walk in inner cities, local grocery stores and the cost of fruits and vegetables in comparison to ‘super-value meals’  but the similarly bad (and deliberate) choices of the more privileged middle-class are ignored.

While I believe that people should take responsibility for their own actions (in all areas of life) we should no longer stand by and allow the damage that is being done to our younger generations.  Obesity among teens and children continues to rise due to poor dietary habits, and inactivity.    At this point;  ‘junk food’ should be regulated like cigarettes and alcohol.

Ten years ago – I would have rebelled as such government intrusion into American life, but ten years ago – I was still relatively new to the devastation caused by diabetes, obesity and related diseases.  These last years have been a crash course in human suffering and a primer in (potentially) avoidable disease.  It has also been eye-opening in terms of human behaviour – and amazing (to me) that serious complications such as heart attacks, strokes, and heart surgery still fail to motivate people to make even small changes in their lifestyles.

Much is made of new medications and treatments for diabetes – but we fail to grasp the essential truth; that we are eating ourselves to death and destroying mankind.  There is no pill for that.

While I generally try to remain upbeat here at Cartagena Surgery, the plague of Diabetes too large for even my sunny nature to overcome.

Bogota Surgery and the International Medical Travel Journal

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Thanks to the eagle-eyed reader who notified me that portions of one of my articles “Bogotá hospital offers hope to abdominal cancer patients” (originally published on Colombia Reports.com) was featured in the article, “Agencies promote Central and Southern American medical tourism.”

I’ve asked them to provide a link to the original article so readers can get more information on the topic.

Update: 29 June 2011: Here’s a link to the new article on Treatment Abroad (which is an International Medical Travel Journal sister site) that gives their readers the information they really need. (The name of the doctor, of course!)  It’s a summary of the original Colombia Reports.com article. They still haven’t cited the ‘borrowed’ content on the original article, or provided the name of the physician doing the treatment (Dr. Fernando Arias) but I guess it’s an improvement.

Liposuction in a Myrtle Beach apartment

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Another case of sketchy plastic surgery reported – this time in Myrtle Beach, South Carolina.   Yet again, I would like to caution readers about seeking ‘cheap’ plastic surgery on the internet.  (I’m not saying don’t look – please do!  But look smartly.)  This doesn’t only apply to plastic surgeons, but to all surgeons, physicians, and healthcare professionals.

‘The internet’ is not all the same – the grade of information can vary widely from scientific journals (highly reputable/ reliable) to fiery but heavily opinionated blogs (unreliable/ unscientific) to frankly fraudulent such as in this instance (in the story above).  People need to use caution, due diligence and common sense when researching anything, but particularly medical information on the internet.  You need to do your homework.

There are a few things to consider when researching medical information/ providers on the internet.

1.  Is the information independently verifiable?  (and by what sources?) 

As a medical writer – this is a huge portion of my job – verifying the information obtained during interviews, etc.  But when you are looking to purchase goods or services – you need to do a little investigative work yourself.  Luckily, once again – the internet makes this simple.

The first thing you should investigate is – the person making the claims/ and what their focus is.  Use this website for an example, if you like.  So take the following information (below) – that is easily available on the site..

(If this information isn’t readily available on the site – that should make you suspicious.  “Anonymous” blogs or hidden author websites are NOT reputable.  People with valid, truthful information have nothing to hide, and are not ashamed to stand by their work/ writings.)

so you’ve gathered the following information  from the site:

Author – XXXX   credentials claimed/ authority source:  Physician (MD/ DO etc.)

Product or service advertised on the site:  surgical procedure XX

Use this information to answer the following questions:

1. Who is this person?

2. How do they know this/ what special knowledge do they possess?  (for example – a hairdresser shouldn’t be giving medication advice)

3.  Can I verify this?

– Medical personnel can be verified thru state licensing boards. 

Some states make this easier than others, but ALL states have this information available to consumers.  So go to the website of the licensing board (medical board for doctors, nursing board for nurses) and look the person up.

In this example, I am currently licensed in several states – so pick one, and do an internet search for the board of nursing for that state.  (Tennessee is particularly easy since they post educational information, license violations etc. on-line).  If this licensing information isn’t easy to find on the website, call the board.**

If the website (ie. plastic surgery clinic) lists an address – use that state for your search.

In another example – as seen below – we’ve looked up a surgeon at the Colorado Medical Board.

Looking up a medical license

Looking up a medical license

– All physicians should be licensed in the state of practice (where their clinic is.)  If they aren’t licensed in that state – STOP and find another provider.  Even if the doctor claims to be from another country, he or she is STILL required to have an active license in the state they are working in.**

Here is an example of physicians sanctioned by the Texas medical board (all of this information is freely available on the internet for your safety.)


Here is another example of a surgeon with multiple medical board actions against her.

licence details

license details

Many of the state medical boards will let you read the complaints, actions and disciplinary measures against physicians licensed in that state.  However, some states allow physicians under investigation to ‘surrender’ or inactive their license to avoid having disciplinary measures recorded.

– All surgeons, or specialty doctors should also be listed with specialty boards – such as the American College of Surgeons, or the American Society of Plastic Surgery.  (While membership is not mandatory, the vast majority of specialty trained surgeons maintain memberships in their specialty organizations.)  Other things to consider while investigating credentials:

Do the credentials match the procedure?  (Is this the right kind of doctor for this procedure?)

These credentials should match the procedure or treatment you are looking for: such as Plastic surgeons advertising breast augmentation.

This may sound obvious but it isn’t always the case.  (for example:  dermatologists shouldn’t be doing eyelid lifts or plastic surgery, primary care physicians shouldn’t be giving Botox injections, general surgeons shouldn’t be performing lung surgery etc.)
If you aren’t sure what procedures the doctor should be performing, look at the specialty surgery board – it should list the procedure.  i.e plastic surgery and liposuction.

4.  After verifying this information, it is time to do a basic internet search on the individual.  To do this – perform both a Yahoo! and Google search.   This should give you at minimum, 10 to 15 results.

These results should include several non-circular results.  “Circular results” are results that return you to the original website, or affiliated websites.   For example: Using the information from above – both Google and Yahoo! return several results that link directly to this website.  These results also return links for the sister sites.  All these of these are circular results – that return you to the starting point without providing any additional outside information.

However, if you scroll down the results:  outside links should appear.  These should include articles/ publications or scholarly work.  Other search results may include more personal information, social networking sites and other newsworthy articles.  This gives you a more comprehensive picture of the provider.

One of the things we should mention, is patient testimonials.  While many providers include extensive patient testimonials, I disregard these for several reasons:

– There is usually not enough information to verify the authenticity of these patient claims.  “I love my doctor. He’s a great surgeon.” – Gina S.  doesn’t really tell you anything.  In particular, there is no way to verify if there really is a Gina S. or if she is a fictitious creation of the website author.  (There have been several cases where people working for the doctors have created ficticious accounts including before and after photos talking about procedures that they never had).  Don’t be lulled into a false sense of security with patient testimonials.

– Some people use blogs, or message boards for the same purpose, and the same caveats apply.

– Another reason that patient testimonials are not useful in my opinion, is that patients (and their families) are only able to provide subjective information.  Several of the cases in the news recently (of fraudulent individuals posing as doctors) had several “happy patients’ to recommend them.  Patients, for the most part – aren’t awake and able to judge whether the surgery proceeded in a safe, appropriate fashion.  The testimonials are merely a comment on the physician’s charisma, which may give future patients a false sense of security.

I’ve finished my search – Now what?

   Use commonsense:

– Surgical treatments should be performed in an appropriate, sterile environment like a hospital or freestanding clinic.  A reputable surgeon does not operate in the back of a motor home, a motel room or an apartment.  (All of these have been reported in the media.)  If the setting doesn’t seem right – leave.  You can also investigate the clinic.

– Bring a friend.  In fact, most surgeons will require this, if you are having liposuction or another large procedure.  Doctors don’t usually drive their patients around (as was done in several recent cases.)  The exception to this rule is medical tourism packages.  These packages often include limousine transportation services but these services are provided by a professional driver (not the doctor, or ‘his cousin’).  Your friend/ companion is not just your driver – they are also there to help feel out the situation.  If something seems amiss – do not proceed.

– if the price is too cheap – be suspicious.  If every other provider in the same location charges a thousand dollars – why is this doctor only charging a hundred dollars? Chances are, it’s not a sale – and he/ she is not a doctor.

– Use reputable sources to find providers – Craigslist is not an appropriate referral source.

– Are the claims over-the-top?  Is the provider claiming better outcomes, faster healing or an ‘easier fix’ than the competition? (We will talk more about this in a future post on  “miracle cures’ and how to evaluate these claims.

I hope these hints provide you with a good start to your search for a qualified, safe, legitimate provider.  The majority of health care providers are excellent, however the internet has given criminals and frauds with an easy avenue to lure/ and trap unsuspecting consumers.

** The majority of cases that have been recently reported have taken place in the United States (Nevada, New Jersey, Florida and South Carolina.)  Many of the people perpetrating these crimes have posed as Latin American surgeons to capitalize on the international reputation of plastic surgeons from South America.  They also used these claims to try and explain away the lack of credentials.  A legitimate doctor from Brazil,  Argentina, Colombia, Costa Rica or another country, who is practicing in the United States WILL HAVE an American license.

Additional references/ stories on fraudulent surgeons.

(Hopefully this section will not continue to grow)

More on the Myrtle Beach story

Myrtle Beach – a nice article explaining why people should see specialty surgeons

Basement surgery

Article on unlicensed clinics in Asia (medical tourists beware!)

A truly bizarre story about unlicensed dentistry in Oregon

Additional references:

American College of Surgeons – lists doctors distinguished/ recognized as “fellows” in the academic organization, and provides a brief summary of specialties.

Plastic Surgery: Breast Augmentation news

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For all of my devoted readers, who have been wondering what I have been doing since I returned from my latest trip to Bogota:

Still traveling around, still interviewing surgeons whenever I get the opportunity.  Today, I spent the day in the operating room in Fresno, California watching a very large cardiac surgery case (Aortic valve replacement/ Mitral valve replacement/ Tricuspid Repair (annuloplasty) with multi-vessel bypass) with Dr. Richard Gregory, MD, a native Fresno resident and cardiothoracic surgeon at St. Agnes Medical Center, in a Stanford affiliated surgery program.  Today’s case seems to tie in (unplanned) with our previous discussions on valve surgery last week.  It was a great – but complex case.

The facility is a private boutique specialty hospital; elegantly appointed with large, well-lit operating rooms.  The surgeon was experienced and talented.  Most importantly, the patient did beautifully.

All international/ national protocols followed with pre-operative time-out (which consists of several criteria to meet the National Surgical Quality Improvement Project (NSQIP) requirement.  (More about this and the surgical apgar scoring system is detailed in Bogota! a hidden gem guide to surgical tourism).  Sterility was maintained throughout the case – and the patient’s hemodynamic needs were promptly and properly addressed.  Continuous Anesthesia / Perfusion monitoring through out the case.

Surgical Apgar scores not applied (not appropriate for this type of case.)

In other surgery news – this time, plastics and aesthetics – the Food and Drug Administration released a new statement today cautioning consumers on the use of Silicone breast implants.  Previously, the FDA had attempted to limit the use of silicone-filled breast prostheses but had been met with significant resistance from groups of consumers who preferred silicone implants over saline filled implants.

In the article (re-posted below) the FDA states that while previous concerns regarding health complications related to the use of silicone implants such as silicone toxicity/ silicone poisoning have not been validated – the FDA cautions that over 20% of women will need to have their breast implants removed within ten years of implantation.  This data confirms information provided during previous interviews with plastic surgeons, who stressed that breast implants are NOT a lifetime device, and several surgeons who stated, “Most patients will need the implants changed within ten years.”  [notably, during these physician inteviews – the plastic surgeons were not specifically talking about silicone breast implants.]

Article Re-post: Medscape

Long-term complications likely with silicone breast implants 

Mark Crane

June 22, 2011 — Silicone gel–filled breast implants are safe and effective when used according to their labeling, but the longer a woman has the implants, the more likely she is to experience complications, the US Food and Drug Administration (FDA) said in a new report released today.

“Breast implants are not lifetime devices,” Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said during a telephone news conference. “One in 5 patients who received implants for breast augmentation will need them removed within 10 years of implantation. For patients who received implants for breast reconstruction, as many as half will require removal 10 years after implantation.”

Women with silicone breast implants will need to monitor their breasts for the rest of their lives. To screen for silent ruptures, women should undergo magnetic resonance imaging 3 years after implantation, and then every 2 years thereafter, Dr. Shuren said. Women with saline implants do not need regular imaging.

When the FDA allowed silicone breast implants back on the market in November 2006, it required manufacturers to conduct follow-up studies to learn more about the long-term performance and safety of the devices. The FDA’s report is based on preliminary safety data from these studies, as well as other safety information from recent scientific publications and adverse events reported to the agency.

The most frequently observed complications and adverse outcomes are tightening of the area around the implant (capsular contracture), additional surgeries, and implant removal. Other complications include a tear or hole in the outer shell (implant rupture), wrinkling, uneven appearance (asymmetry), scarring, pain, and infection.

Studies to date do not indicate that silicone breast implants cause breast cancer, reproductive problems, or connective tissue disease, such as rheumatoid arthritis, the FDA said. However, no study has been large enough or lasted long enough to completely rule out these and other rare complications.

“Most women report high levels of satisfaction” with their implants, Dr. Shuren said.

The FDA is working with the 2 manufacturers who make silicone breast implants, Allergan and Mentor, to address the challenges in collecting follow-up data on the women who have received these implants.

Approximately 5 to 10 million women worldwide have breast implants. In the United States, 296,203 breast augmentation procedures and 93,083 breast reconstruction procedures were performed last year, according to the American Society of Plastic Surgeons. About half the procedures used saline implants, and half used silicone implants.

Patients with either saline or silicone implants may have a very small risk for a rare cancer called anaplastic large-cell lymphoma (ALCL) adjacent to the implant. However, the risk is “profoundly small,” said Dr. Shuren. “Since 1997, there are only 34 cases in the published literature, and at most 60 cases out of the 5 to 10 million women with implants worldwide,” he said. “We don’t yet know if there is a causal link.”

When the FDA first released information about the risk in January, William Maisel, MD, MPH, chief scientist and deputy director for science in the FDA’s Center for Devices and Radiologic Health, said the evidence suggests that the kind of ALCL found in conjunction with breast implants is less aggressive and is sometimes treatable by simply removing the implant, the capsule, and the collected fluid.

“The FDA will continue to monitor and collect safety and performance information on silicone gel–filled breast implants, but it is important that women with breast implants see their healthcare providers if they experience any symptoms,” Dr. Shuren said. “Women who have enrolled in studies should continue to participate so that we may better understand the long-term performance of these implants and identify any potential problems.”

The FDA is holding an expert advisory panel in the next few months to discuss how postapproval studies on breast implants can be more effective.

The FDA will issue an update at a future date on saline implants, Dr. Maisel said.

All serious adverse effects should be reported to the breast implant manufacturer and Medwatch, the FDA’s safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

Diabetes and Soft drinks

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If I can get readers to make one significant change to improve their health today  – Stop drinking soft drinks (and juices.)  These high sugar containing drinks are more than just empty calories, and this one small change can significantly reduce your risk of developing diabetes!

(P.S.)  Substituting for diet drinks is no improvement since diet sodas etc. have been linked to an increased incidence of strokes and high blood pressure (HTN) – switch to coffee, tea or water!!)  Coffee has even been shown in several studies as reducing the risk of diabetes, pancreatic disease.

High Fructose Corn Syrup

High fructose corn syrup was a uniquely American product that was initially created as a result of a government subsidy for farmers which has since spread to the UK, Japan and several other nations.  With these government subsidies, corn syrup became a cheaper sweetening agent in comparison to cane sugar.  This led to the pervasive use of corn syrup in many American food products.   Today it is used extensively, and avoiding this additive requires considerable effort and extensive examination of product labeling.  One of the main products that uses large amounts of high fructose corn syrup are soft drinks such as Pepsi and Coca-Cola.

As the American obesity (and corresponding Diabetes) epidemics continue unchecked, multiple researchers have attempted to pinpoint causes for these phenomena.  High fructose corn syrup has emerged as a likely culprit.  (However, even this scientific research is politically charged, as mega-corporations attempt to discredit findings that hurt their bottom line, similar to tobacco manufacturers in the past[1].)

Stanhope & Havel (2010), researchers at UC Davis recently compared the effects of fructose ( high fructose corn syrup is a mixture of fructose and sucrose) to sucrose (regular table sugar.)  They found that fructose use increased visceral adiposity (fat around internal organs), dylipidemia and decreased insulin sensitivity.  Decreased insulin sensitivity is a hallmark of the development of diabetes and is one of the ways that Diabetes in Americans differs from diabetes in other countries.  This means that people need more insulin to do the same job (transport nutrients into the cells).  This is also why we see people requiring more insulin that ever before.  In the past, patients could often be managed with 5 units of insulin (per meal).  Now, more commonly, due to this insulin resistance, similar patients are requiring 50 units of insulin (per meal).

But the problem isn’t just high fructose corn syrup – it’s our overall sugar consumption in general – Americans are just consuming WAY, WAY too much sugar – in “energy’ drinks, colas,  designer coffee drinks, ‘sweet teas’ and the so-called ‘healthy fruit juice.’  [I cringe every time I see a parent give their child juice as a ‘healthy alternative.’]

This sugar is KILLING us, by causing a myriad of health problems which in turn have a domino effect causing even greater health problems..  Sugar —->  Obesity/ High cholesterol ——>diabetes , hypertension,  atherosclerosis ——-> coronary artery disease (heart attacks), renal failure, vascular disease (ischemia/ limb loss/ strokes)..  The obesity epidemic, and sugary drink consumption has also been linked to fatty liver disease.

Now Malik, et. al. (2010) over at Harvard/ Brighams performed a meta-analysis on this subject.  Now if it’s been a while since you’ve read a lot of scientific literature, then let me remind you that meta-analyses are fairly high-powered studies because they take  ALL of the existing data, compiled it, and report the findings.. This is much stronger evidence that some six person study looking at cinnamon and diabetes.  (Yet – the media blazed that study everywhere – so  now plenty of people are putting cinnamon in everything.)

Readers:

Starting today – I want you to care about your health, more than drinking that coke, pepsi or kool-aid.  Don’t try to cheat – with ‘diet’ options – because you are only cheating/ fooling yourself..

Make this one change:  switch to water, coffee (not loaded down with sugar/ cream) or UNSWEET tea.

Try it for at least thirty days..  and let’s start from there..   Just this one small change, not because I asked – but because you love yourself.  (And if you don’t love yourself – we need to work on that too!)

Additional references:

This study says diet sodas don’t cause diabetes but does link it to strokes..   It’s from MSN health which is an ‘okay’ site for consumer health information (articles are not always well written.)

Four reasons to avoid sodas – Health content from Yahoo! – it’s actually a reader’s digest article, which I typically avoid because they are usually poorly written, and not factually based.

[1] A good rule of thumb:  Whenever an industry starts advertising for their product (versus individual brands) than strong scientific evidence has probably emerged implicating the product in serious health conditions.  Think of the recent corn syrup ads, and “Beef – it’s for dinner,” and other campaigns in the past.

Bariatric Surgery: latest headines

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I am traveling all day today so just a quick post today with some new links:

Several headlines recently posted on-line.

Weight loss surgery & depression  article states that depression doesn’t prevent weight loss after surgery .   Now, what would be interesting – is whether depressed patients were more likely to dispay or revert to disordered/ sabotage behaviors such as the ‘drinking butter’ phenomena.

(Often when weight loss surgery fails – it fails because of maladaptive behaviors.  These behaviors are often similar to the behaviors that caused obesity/ overeating in the first place such as identifying “food as love,”using for as a coping mechanism for emotional pain (the so-called ‘comfort food’, which is a concept that needs to be banned from society), and other eating behaviors unrelated to physical hunger.

This is why most surgery patients are required to see a mental health specialist to identify and treat ‘food issues prior to surgery’.)  But depression (which may cause overeating for some people) is not the same as neuroses or maladaptive coping mechanisms.   This also includes post-surgery behaviors that we have alluded to in the past, such as attemping to ‘trick’ or circumvent capacity restrictions by continuous eating (sipping or eating every few minutes for several hours during the day.)

Weight loss surgery decreases migraines.

Weight loss surgery helps women with Polycystic ovary syndrome and infertility  -this article was actually written by another nurse, and talks about the effects of gastric bypass on women with PCOS.

Now, the only thing that concerns me – is having gastric bypass surgery to then boost fertility with pregnancy to follow in a short time is a lot to put a body through.  Practically, a person should probably wait a year or two after the surgery to let the person have time to adjust to the new nutritional requirements, and lifestyle changes surgery requires  before placing additional metabolic and nutritional requirements that pregnancy demands.

Also, the pathological eating that often occurs during pregnancy needs to be addressed prior t planning a pregnancy.  (The “eating for two buffet” mentality often results in pregnancy weight gains of 60, 70 or even 100 pounds which places the mom and developing fetus at risk for additional health problems as well as post-partum obesity.

But gastric bypass surgery, like any medical procedure is not all benefits and no risk – there have just been less headlines this week.  But more than half of gastric bypass patients regain the weight – often due to the behavior patterns we briefly touched on above.

Note: some of the articles linked are older (2001, etc) but I try to provide links to free articles, not paid sites (articles average about 30.00 when for purchase.)

Aortic Stenosis and TAVI: a new ‘stent’ scenario?

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I am re-posting an article published in May on the heart.org by Reed Miller regarding the use of Transcutaneous Aortic Valve Intervention (TAVI).  TAVI is when a device is implanted in the cardiac cath lab (through an artery) to treat aortic stenosis.  Right now, this therapy is still in limited use in the United States, but is used more extensively in Europe where the guidelines are less restrictive.

I was a little disappointed here because I think some of his introductory language shows significant bias – but I think this article certainly adds to some of the discussions we’ve had here at Cartagena Surgery.  Even the title reflects a cardiology bias – cardiothoracic surgeons certainly aren’t the only ones who think we should be cautious about the overimplementation of new, experimental technologies in patients who are good candidates for existing (and proven) surgical treatments.   I would think that any prudent health care provider, or consumer would be hesitant to wholeheartedly embrace this therapy given the previous and recent cardiology lessons related to both carotid and cardiac stenting.

New technology is great – when it is selectively targeted to specific populations (high-risk surgical candidates such as extreme elderly (90+) or patients with multiple high risk co-morbidities) who would otherwise be ineligible for surgical intervention.  But let’s not put our patients at unnecessary risk by selling TAVI as an ‘easy’ fix to people who we know we benefit from aortic valve replacement surgery before we have all the data.

There are still multiple issues to be addressed with transcutaneous valve therapies – we don’t even know the durability of this technology (how long with they last?)  or the long-term complications..   Also when we compare ourselves to European practices, we need to remember that ‘acceptable thresholds’ may differ significantly.  At what level of risk of stroke are YOU willing to accept?  5 % ?  10% ?  25% ?  And doesn’t that depend on whether you are eligible to have other therapies, and what the risks of those therapies are?

Lastly, it’s important to note that the study in question – which revealed a higher than expected stroke rate was funded by the corporations that manufacture and supply these valves.  We’ve seen before how this can influence the practice of cardiology and cardiology guidelines.

Article re-post below: [my comments in brackets.]

Surgeons caution against

 overenthusiasm for TAVI in light of

PARTNER A stroke data

May 10, 2011            |            Reed Miller

Philadelphia, PA – The neurological injury data from the PARTNER cohort A trial of transcatheter aortic-valve intervention (TAVI) underscore the importance of the collaboration between surgeons and interventionalists when making decisions on how to treat patients in need of a new aortic valve, surgeons here at the American Association for Thoracic Surgery (AATS) 2011 Annual Meeting agreed.

As reported by heartwire, Dr Craig Miller (Stanford University, CA) presented new details on the neurological-event data from PARTNER cohort A, which included high-risk patients eligible for either surgery or TAVI. [‘high risk’ needs to be better defined if the patients were considered acceptable surgical candidates.] 

The data showed that the risk of neurological adverse events (transient ischemic attack [TIA] and stroke) was slightly higher with TAVI than surgery in the “as-treated” patients, especially in the patients who underwent transapical TAVI because their vessels were too small to accommodate a transfemoral implant, usually because they were obstructed with arteriosclerosis. Rates of major stroke, however, were not statistically different between the two groups in the as-treated analysis.  [numbers/ percents – I need hard data..]

Because of the added neurological risk, Miller believes TAVI should not replace surgery for most patients who can withstand surgery. So he is dismayed that it has grown so rapidly in some European countries where TAVI devices are commercially available, even though the durability of these devices has not been proven. “This is not going to be cost-effective, and civilization cannot afford this if they do not last a good amount of time, and a good amount of time would mean something different to a 95-year-old who is inoperable and to somebody under 70 with a very low surgical risk who should have 10- to 20-year life expectancy. So we have to look at valve durability,” he said.  [I wholeheartedly agree. All of Dr. Miller’s concerns are valid.]

“There are many [inoperable patients like] the people in PARTNER cohort B, who gained 1.9 quality-adjusted life-years, and it only cost $55K per QALY to achieve that. So for the inoperable cohort, it is cost-effective and actually provides meaningful rehabilitation, but the jury is out for the younger patients,” he said. “But the cost economics of the not-so-sick operable patients is going to be different; they’re still beaucoup sick and old in PARTNER A, but to take this down to younger, healthier patients is a huge question mark in my mind and in the FDA‘s mind, because we already have the gold standard of low-risk, durable, surgical [aortic-valve replacement],” Miller said.

Surgeon/interventionalist collaboration is critical

Miller thinks one reason that TAVI has become “a runaway train” in Europe is that in some countries there, interventionalists are able to decide to implant a transcatheter valve without consulting a surgeon or, in some cases, even having a surgeon on site. “The German Federal Ministry of Health didn’t have the backbone to stand up and legislate appropriate use, so it’s a free-for-all. But that would be wrong, especially since we don’t have durability data,” Miller said. Miller said he learned that about a quarter of aortic-valve replacements in 2010 in Germany were TAVI procedures, but Dr John Mayer (Children’s Hospital Boston, MA) reported at the meeting that the figure is now around 40%.

A good amount of time would mean something different to a 95-year-old who is inoperable and to somebody under 70 with a very low surgical risk who should have 10- to 20-year life expectancy.

Mayer and Dr Grayson Wheatley III (Arizona Heart Institute, Phoenix) echoed Miller’s concerns about overenthusiasm for TAVI during a staged luncheon debate on whether or not expensive technologies like TAVI ought to be somehow rationed to control healthcare costs. Mayer took the position of defending rationing and Wheatley argued against it, but they both agreed that physicians and their professional societies ought to work to ensure appropriate use of TAVI.

Wheatley said, “We’re probably going to see something along the carotid-stent paradigm, where it’s FDA approved, but [the Centers for Medicare & Medicaid Services] CMS has restricted [coverage] of an FDA-approved device, based on the data and economics, to the highest-risk patients. I see a lot of parallels there.”

“The Medicare national coverage decision process is going to undoubtedly come into play,” Mayer agreed. “That’s one way to control it, and that’s probably the biggest weapon in the arsenal.” Mayer said that the CMS is already discussing a future Medicare coverage policy for TAVI with the Society of Thoracic Surgeons (STS).

“But the other way to control it is to take the combined cardiology/cardiothoracic surgery approach to be careful about how this gets rolled out,” he said. The STS and the American College of Cardiology (ACC) are currently working on a joint position paper that will call for TAVI appropriateness guidelines based on the PARTNER results, Mayer pointed out. That paper will likely be published this summer. “That’s an extremely important step, and I think the government will understand and accept a lot of the recommendations in there.”

Meanwhile, the Society for Cardiac Angiography and Interventions (SCAI) will be contributing to the STS/ACC position paper and is also developing an expert consensus document with representatives from the AATS, STS, and ACC that will outline training and facility standards for performing TAVI. That document will be published prior to the TCT 2011 conference, according to SCAI.

“The difference between how this was rolled out in Europe and how the investigators in the PARTNER trial would like to roll it out in the United States is that a heart team with a surgeon and cardiologists—and not just the interventional cardiologists, but general cardiologists—make the decisions jointly. That is the model that we think should be imposed going forward,” Mayer said. This collaboration will “be a way of us fulfilling our professional responsibility and making sure that this gets rolled out with high quality and will have the side benefit of keeping it from going nuts like it has in Europe.”

While some may be better off undergoing surgery than transfemoral TAVI, there are also some patients whose risk of neurological injury is so high due to arteriosclerotic burden that they are probably not suitable for either surgery or TAVI, Miller said. “The only thing that’s going to change that is more rigorous patient selection and just saying no,” Miller told heartwire. “That might not go over well in the US where everybody demands everything yesterday, [but] since these are patient-disease-related predictors, more rigorous patient selection is the only thing that will reduce the late hazard of neuro events [in patients with very high arteriosclerotic burden].”

What does PARTNER cohort A reveal about the cause of strokes?

STS president and PARTNER investigator Dr Michael Mack (Medical City Dallas Hospital, TX) told heartwire, “There was an initial thought for the past few years that the transapical might be more neuroprotective than the transfemoral because you don’t transverse the aortic arch with the device, and I think this puts to bed that that was not the case. In fact, the stroke rate was higher in the transapical than in transfemoral, but the presentation showed that it was clearly related to the patient substrate.” The one-year stroke rate in the transfemoral-eligible surgery patients was 1.9%, while the one-year stroke rate for the same surgical procedure in transfemoral-ineligible patients was 9.7%, Mack pointed out. “That says they’re different patients [with] a higher atherosclerotic burden.”

[Collaboration will make] sure that [TAVI] gets rolled out with high quality and will have the side benefit of keeping it from going nuts like it has in Europe.

Mack pointed out that the version of the Sapien valve (Edwards Lifesciences) tested in PARTNER was a first-generation device that did not have the nose cone that newer versions will have, “so you basically had this snowplow that could go across the aortic arch and scrape stuff off; smaller delivery devices with nose-cone protection may be expected to be of benefit,” Mack said. However, previous studies with transcranial Doppler show that the majority of the emboli come from the valve during balloon valvuloplasty and deployment of the valve and not from the aortic arch. “[This is] why you don’t see a benefit of the transapical here, because you’re still blowing up that valve [inside the native valve].”

This explanation is consistent with the study’s finding that, in the first few weeks following the procedure, a smaller valve opening area, which is usually a sign of high calcification around the opening, was associated with a higher risk of neurological events in the TAVI patients. Embolic-protection devices, such as Edwards’s Embrella, may catch some of these emboli released during the valve deployment, Mack said, but clinical experience with these devices is very limited so far.

Better devices may stop a lot of the periprocedural events, but about half of the neurological events happened after the periprocedural period. In this period, the most important risk factor—other than undergoing TAVI instead of surgery or being transfemoral ineligible—was a stroke or TIA within the previous six to 12 months. Atrial fibrillation, which was predicted by some to possibly be a risk factor for strokes, was not associated with an increased risk of neurological events in the study. Dual antiplatelet therapy was recommended for all patients in the trial, but the trial could not track how compliant patients were with that therapy.

“We have absolutely no clue if these strokes were device related or not. We don’t know if the device is thrombogenic, or if all that calcium left in the aorta hanging out eventually breaks out, or if it’s a nidus for clot formation and that breaks off. We just don’t have any insight on that,” Mack said.

PARTNER was sponsored by Edwards Lifesciences. Miller has consulting arrangements with Medtronic CardioVascular, Abbott Vascular, and MitraClip. Mack consults for Edwards Lifesciences and Medtronic.

Aortic Stenosis: More patients need surgery

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An interesting new article on the use of echocardiography (cardiac ultrasound imaging) to determine the optimal timing of aortic valve replacement is re-posted below.  This article is helpful for several reasons, but first a quick summary of Aortic Stenosis.

The timing of aortic valve replacement surgery for aortic stenosis (here after referred to as AS) has always been a complicated issue.  Not all stenotic valves need to be replaced at the time of diagnosis; in fact, most don’t since AS is usually diagnosed early (from the presence of a new heart sound on physical examination.)

Patients may not need surgery for ten or twenty years after AS is initially detected, and performing surgery at the RIGHT time is important.  Performing surgery too early has almost as many drawbacks as performing surgery too late.

Ideally, surgery is performed before the patient becomes symptomatic (fainting/ near fainting, chest pain or the development of heart failure) AND before the development of heart damage from AS.

Article re-post:  [my comments in brackets]  I have also italicized certain portions for emphasis.

Echo predicts mortality in untreated

 Aortic stenosis with normal LV

function

Article authored by Marlene Busko, Heartwire.com  (June 17th, 2011)

Montreal, QC – Researchers have identified four  echo markers that predicted mortality in elderly patients with severe aortic  stenosis but preserved LV function who did not undergo surgical valve  replacement [1].
Dr Eddy Barasch (St Francis Hospital, Roslyn, NY) presented the  study here at the American Society of Echocardiography (ASE) 2011 Scientific  Sessions.

The four echocardiographic markers that predicted poor  survival were greater left ventricle (LV) concentric remodeling, lower stroke  volume, elevated LV filling pressures, and mildly elevated pulmonary artery pressure.

“Our findings may not be generalizable, but they suggest that in [elderly, symptomatic patients with untreated aortic stenosis] with normal LV function, no other valve disease, and normal sinus rhythm, these  echocardiographic parameters may be useful for risk stratification,”
Barasch told heartwire. Being able to predict mortality with surgery vs medical therapy in patients such as these—who are typical of patients seen in clinical practice—will become even more important when  transcatheter aortic-valve implantation (TAVI) becomes available, he added.

The data suggest that “not operating on symptomatic  patients like this—with these markers—is really a death sentence,” said Dr Malissa Wood (Massachusetts General Hospital Heart Center, Boston), when asked to comment on the study.”When you are managing patients who may in  fact be good candidates for surgery, looking at their echo and figuring out if
they have these risk factors can help determine the patients’ overall risk of
mortality with surgery vs medical therapy,” she added.  [I completely agree with Dr. Woods, which is why we need to be frank in our discussions of the real risks of surgery and the risks of NOT having surgery.]

Surgery seen as “too risky”

The prevalence of aortic stenosis increases with age, and it is estimated that among 80-year-olds, as many as one in four have aortic stenosis, and about 3% to 5% have severe aortic stenosis, Barasch explained.   However, a significant proportion of patients with aortic stenosis—30% to  40%—are denied surgery for various reasons, he noted. The patients may have
multiple comorbidities, be too old and frail, or may not want to have surgery.

In some cases, a primary-care physician may not refer a patient for surgery due to perceptions that the procedure is too risky, while in others, a surgeon may decide that a referred patient is not a good candidate for surgery, Wood added.
[The wording here is deceptive – if a patient decides not to have surgery – they weren’t ‘denied surgery’.  People have the right to decide for themselves – as long as we ensure that we explain everything to them in terms they can understand.  This phrasing is concerning now that many cardiologists are performing experimental transcutaneous valve procedures – sounds like cardiologists are opening the door to doing this procedure in patients that may not otherwise be candidates under “the patient was denied surgery/ patient refused surgery” model which we’ve seen many times before with stent patients.]

[The other issue that we will talk about in a future post is the “primary care provider (PCPs)” not  referring patients that he/she doesn’t think are good candidates.  Frankly, most PCP  and cardiologists, for that matter, are not qualified to make that determination.  As you will read further into the article and see – the outcomes of untreated AS are quite grim, so the
decision on whether or not to refer a patient for evaluation, is not one to be taken likely.]

“On the other hand, if you don’t treat these patients surgically, mortality is increased twofold,” said Barasch.

Although most elderly patients with severe aortic stenosis have preserved LV function, few studies have examined how risk factors  affect survival in this patient subset. To identify echo variables associated  with mortality in these patients, the team reviewed the charts of 443
consecutive patients with severe aortic stenosis and preserved LV ejection fraction who had echo Doppler in their center from 2003 to 2010.

After patients who underwent surgical aortic-valve replacement were excluded, the study population comprised 274 patients with a mean age of 79.5 years (51% men). [this is quite a large subset of patients that didn’t/ couldn’t/ didn’t want surgery.  I’d like to know why, and who decided (other than the patients themselves). We successfully do aortic valve replacement in many patients over 80 (age itself should NEVER be a factor – as discussed in numerous previous posts.]

All but two patients had symptoms of heart failure (45%), angina (33%), syncope (5%), or multiple or other symptoms (17%).  All patients had normal sinus rhythm, and their mean LVEF was 64.5%+9.4%.

After a mean follow-up of 3.2+2.7 years, 50.5% of the patients had died.

The patients who survived were younger, had a higher body-mass index (BMI), and were less likely to have hypertension, renal insufficiency, diabetes, or heart failure, and more likely to have CAD.

Of the multiple echo-Doppler variables that were examined, only four parameters—LV concentric remodeling (increased LV wall thickness), lower stroke volume, elevated LV filling pressures, and mildly increased pulmonary artery pressure—were moderately associated with mortality,  after researchers adjusted for age, gender, and BMI.

No surgery also ups risk

“The biggest take-away message is that we are still grossly undertreating symptomatic aortic stenosis, and many patients who would benefit from surgery are not getting it,” Wood summarized.  The study helps identify the magnitude of the risk of not having surgery, among these elderly patients.  [Actually, we’ve known these statistics for at least twenty years – I had to memorize them for student rounds when I was graduate school, as standard fare for grilling by the cardiac surgeon.]
“It is a strong study—useful for risk/benefit analysis,” she concluded.

Unfortunately, much of this article seems to state that the biggest obstacle to patient care, safety and welfare seems to be the referring physicians themselves.  In my opinion, ALL patients with AS should be referred to a cardiac surgeon (not because I work for one) but because ONLY the surgeon and the patient can truly decide whether its’ time for surgery/ and if the benefits outweigh the risks.

So, if you have Aortic stenosis, symptoms or not – get your more recent echocardiogram, a list of all your medications, and as many medical records as you can get – and schedule an appointment with a cardiac surgeon for a second opinion.

I’ll be posting some additional articles and references for interested readers soon.

 

Aortic Stenosis as Heinz 57

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“Aortic Stenosis as Heinz 57”

I apologize, but the best analogy I can use – is a squeeze ketchup bottle.

okay, it's not heinz.. but you get the picture..

In normal valve functioning, the three valve leaflets open and close fully to permit and control the flood of blood from the left ventricle to the aorta, where it is then circulated throughout the body.

normal valve diameter

During diastole (the filling phase) the leaflets are shut to prevent blood from leaking backwards from the aorta into the heart.  (When leaflets don’t close properly this is called aortic regurgitation.)

During systole, the ventricle contracts like a big fist,  squeezing the ketchup bottle to shoot blood out of the heart into the aorta.  (The force of this is measured in millimeters of mercury, and is the top number on your blood pressure cuff).  When the valve is working normally, it opens fully and the blood is ejected out to the aorta, and the whole cycle begins again.

In Aortic Stenosis – the valve leaflets have become fused together, either from age or disease.
(Some people are born with only two valve leaflets and this means that they are more likely to develop aortic stenosis as they age.)  As aortic stenosis progresses, the opening for blood to pass thru becomes smaller and smaller since the leaflets can not longer open fully,  In many people – at the time of surgery – this opening is about the size of the pinhole in the ketchup bottle that squirts ketchup.      (The normal sized opening is 2 to 3 centimeters).

average valve opening in severe aortic stenosis

Now, think about how hard a person has to squeeze that ketchup bottle to get some ketchup for hamburgers, fries (and all the other foods I usually scold about in other posts).
In the heart – this pressure is magnified (and can be measured in the cath lab during cardiac catheterization).

As this pressure gets higher and higher to compensate for the narrowed opening, the delicate structures of the heart become damaged, with the heart muscle becoming thicker and less flexible (just like any other muscle with exercise.)  Except unlike biceps, a big thick heart muscle is not a good thing, and can lead to heart failure, arrhythmias and sudden cardiac death.

Eventually, as the heart pushes against the increased pressure, over and over (at least sixty times per minute) the heart gets tired from working so hard.  As the heart fatigues, it is unable to keep up with demand and patients will begin to develop symptoms.

These symptoms include:

Syncope/ near syncope (fainting or near fainting) as not enough blood is pushed into central circulation and to the brain.

Chest pain – because not enough blood is pushed out to the coronary arteries during diastole.  (In a person with aortic stenosis, nitroglycerin can cause problems – as it lowers blood pressure  (and force of contraction even further in someone who needs the extra force.)

Heart failure – the weakened and thickened heart can no
longer keep up and blood begins to back up in the left ventricle.

What these symptoms predict:

Once these symptoms develop, doctors can readily estimate the approximate longevity for patients who do not subsequently have surgery.

From the natural history of aortic stenosis (from before we had surgery to treat it) we know that 50% of people with Syncope will die within 5 years.

Fifty percent of people with chest pain die within three years.

And ultimately, fifty percent of people with heart failure die within two years.

These numbers are important, and I want you to remember them for our subsequent discussions on aortic valve replacement because they need to be factored into a patient’s decision whether or not to pursue surgery.

More gastric bypass news

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In a new story by Megan Brooks over at Medscape, “Gastric Bypass Has Advantages in Less Obese Patients” – the latest news from an Orlando conference confirms what cartagena surgery fans already know; that gastric bypass surgery is a viable and effective option in moderately obese patients (particularly patients with diabetes.)  This is encouraging in the continuing battles between patients and insurance providers.

As we’ve said before – it’s important to treat obesity definitively before patients develop serious and potentially life threatening complications such as diabetes and hypertension, and the sequelae related to this (coronary artery disease, ischemic limbs, stroke, renal failure).

In order to treat this effectively and aggressively, we shouldn’t wait until the problem is out of control.  A patient shouldn’t have to be 600 pounds for the doctors to consider bariatric surgery – we should help people before that.

I’ve re-posted the article below. [italics are mine.]

Gastric Bypass Has Advantages in Less Obese Patients

June 16, 2011 — There are benefits to performing laparoscopic Roux en Y gastric bypass (RYGB) in obese patients who have a body mass index (BMI) below 35 kg/m2, according to a study reported at the American Society for Metabolic and Bariatric Surgery 28th Annual Meeting in Orlando, Florida.

Among patients who underwent the surgery, the rates of remission of type 2 diabetes were higher in those with a BMI below 35 kg/m2 than in those with higher BMIs. The “less obese” patients also lost a greater percentage of their excess weight in the first year after surgery than their peers with higher BMIs.

“The study raises the question of whether early referral leads to better outcomes,” John Morton, MD, director of bariatric surgery at Stanford Hospital & Clinics at Stanford University in Palo Alto, California, and an investigator with the study, noted in a conference statement.

“Bariatric surgery is tremendous for weight loss, but its other big advantage is improving medical problems, in particular type 2 diabetes,” Dr. Morton noted in an interview with Medscape Medical News.

Outcomes Better at Lower BMI

Current guidelines from the National Institutes of Health recommend that gastric bypass be reserved for patients who have a BMI of 35 kg/m2 or higher and an obesity-related condition, or who have a BMI of at least 40 kg/m2.

Dr. Morton’s team took a look back at 980 patients who underwent laparoscopic RYGB at their institution between 2004 and 2010. “We ask patients to lose some weight before surgery because it’s a good way to make sure they are committed to the program, and it makes the surgery a little bit safer,” Dr. Morton said. “Therefore, we had some patients below a BMI of 35 kg/m2 at the time of surgery.”

For the analysis, the patients were grouped according to their presurgery BMI: below 35 kg/m2, 35 to 39.9 kg/m2, 40 to 49.9 kg/m2, and above 50 kg/m2.

“When we examined type 2 diabetes resolution rates, we found that those with the lowest BMI had the best resolution rates,” Dr. Morton reported. All 12 patients with a BMI below 35 kg/m2 no longer had type 2 diabetes after surgery, whereas patients with higher BMIs had remission rates of roughly 75%.

“We are looking to entertain the idea that maybe obese patients should have the option of surgical intervention for their diabetes sooner rather than later because, as the study showed, as the BMI gradient goes up, your diabetes resolution rate with surgery goes down,” Dr. Morton said.

The researchers also found that patients with a BMI below 35 kg/m2 who had the surgery had lost more of their excess weight at 3, 6, and 12 months than patients with a higher BMI.

After 1 year, the patients with BMIs below 35 kg/m2 had lost 167% of their excess weight. By comparison, those with a BMI from 35 to 39.9 kg/m2 had lost 112%, those with a BMI from 40 to 49.9 kg/m2 had lost 85%, and those with a BMI above 50 kg/m2 had lost 67% of their excess weight.

Laparoscopic RYGB also took less time in patients with the lowest BMI (170 minutes) than in those with higher BMIs (177 minutes, 182 minutes, and 194 minutes, respectively).

Reevaluation of BMI Guideline Needed

In an interview with Medscape Medical News, John David Scott, MD, a bariatric surgeon at Greenville Hospital System University Medical Center in South Carolina, who was not involved in the study, said that “the BMI level of 35 is an arbitrary standard set many years ago that certainly needs to be reevaluated.”

“Most of the evidence that has been coming out lately has shown not only a positive weight loss benefit for that particular group, but also positive overall health effects,” he added. “In particular, the resolution of diabetes is astounding. To be able to offer patients a surgical cure for their type 2 diabetes is very exciting,” Dr. Scott said.

Dr. Morgan has disclosed no relevant financial relationships. Dr. Scott reports receiving speaker fees from WL Gore & Associates and fellowship support from Ethicon Endo Surgery.

American Society for Metabolic and Bariatric Surgery (ASMBS) 28th Annual Meeting: Abstract P-54. Presented June 16, 2011.

In other news, from the same conference (Megan Brooks reporting) – patients undergoing successful bariatric surgery (with resultant weight loss) had decreased rates of heart attacks and stroke.
“Bariatric Surgery good for the Heart”

June 16, 2011 — Bariatric surgery and the significant weight loss it achieves can  significantly reduce the incidence of myocardial infarction (MI), stroke, and premature death, according to a study presented at the American Society for Metabolic and Bariatric Surgery (ASMBS) 28th Annual Meeting in Orlando, Florida.

“In addition to weight loss, bariatric surgery offers patients a whole host of health benefits, including a reduction in the risk of major cardiovascular problems,” study presenter John David Scott, MD, a bariatric surgeon at Greenville Hospital System University Medical Center in South Carolina, noted in an interview with Medscape Medical News.

“There is a long line of studies showing that bariatric surgery affects cardiovascular outcomes,” Dr. Scott noted. “The difference between our study and other studies is that we looked at major cardiovascular events (heart attack and stroke), whereas a lot of other studies have looked at risk for these events.”

The researchers reviewed data on 9140 morbidly obese individuals, 40 to 79 years of age, who had undergone bariatric surgery (n = 4747), gastrointestinal (GI) surgery (n = 3066), or orthopedic surgery (n = 1327) in South Carolina between 1996 and 2008.

The GI group (hernia or gallbladder) and the orthopedic group (joint replacement) served as control groups because of their similar health and risk profiles, the authors note.

All patients had similar a health status before surgery and no history of MI or stroke. The patients were followed to the end points of first MI, stroke, transient ischemic attack, or death.

“Life-table analysis demonstrated significantly improved event-free survival in the bariatric patients within 6 months of surgery, and it was sustained over time,” the authors note in the meeting abstract.

Five years after surgery, an estimated 85% of bariatric surgery patients were free of MI and stroke, compared with 73% of orthopedic patients and 66% of GI patients, the researchers say.

At 10 years, event-free survival was 77% in the bariatric group, 64% in the orthopedic group, and 62% in the GI group (P < .05).

After adjustment for differences in age and relevant comorbidities, bariatric surgery was an independent predictor of event-free survival. Compared with orthopedic surgery, the hazard ratio (HR) was 0.57 (95% confidence interval [CI], 0.47 to 0.69); compared with GI surgery, the HR was 0.35 (95% CI, 0.29 to 0.43).

“Important Area of Emerging Study”

In a statement from the ASMBS, Anita Courcoulas, MD, MPH, director of minimally invasive bariatric and general surgery at the University of Pittsburgh Medical Center, Pennsylvania, who was not involved in the study, said: “The impact of bariatric surgery on both cardiovascular risk factors and events is an important area of emerging study.”

The findings, she said, are “suggestive of an association between undergoing bariatric surgery and improved event-free survival. This relationship needs to be further explored with prospective clinical data, but still highlights the importance of understanding the broader impact of bariatric surgery on long-term outcomes.”

In an interview with Medscape Medical News, John Morton, MD, director of bariatric surgery at Stanford Hospitals & Clinics at Stanford University in Palo Alto, California, who was also not involved in the study, made the point that “obesity affects every single body part and if you are able to affect the weight, you’re going to help other medical problems — particularly the ones that are inflammatory-mediated.”

“Obesity is really an inflammatory-mediated disease, and stroke, cardiac risk, and even diabetes are now being recognized as inflammatory-related. With weight-loss surgery, direct markers of inflammation go down and, more importantly, these diseases get better,” Dr. Morton explained.

Studies have shown that morbidly obese patients can lose 30% to 50% of their excess weight in the first 6 months after surgery, and 77% as early as 1 year after surgery.

American Society for Metabolic and Bariatric Surgery (ASMBS) 28th Annual Meeting. Abstract PL-105. Presented June 15, 2011.

The Future is Now – HIPEC in the news again..

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Another article on the effectiveness of HIPEC (cytoreductive surgery with intraoperative hyperthermic chemotherapy) in the news.  This story comes out of India and highlights doctors there and the HIPEC procedure for treatment of abdominal cancers (intestinal and ovarian cancers.)

The Future is Now..  in an article on Medscape, dated December of 2010 and originally published in Future Oncology, Dr. Ze Lu et. al discusses the future of cancer treatment.  (The article is several pages in length – so I haven’t re-posted but reference information is provided below).  Dr. Ze Lu and his colleagues believe the future of oncology treatment is…. Intraperitoneal Hyperthermic Chemotherapy (HIPEC)..

In August, we’ll check back in with Bogotá’s resident expert on HIPEC, Dr. Fernando Arias.

Reference:

Lu, Z., Wang, J.,  Wientjes, G., & Au, J. (2010).  Intraperitoneal therapy for peritoneal cancer.  Future Oncology. 2010 (6) 10; 1625 -1641

A frank talk about Diabetes: part one

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We are going to switch gears a little bit today.  Instead of our usual discussions relating to surgery, surgical procedures and medical (surgical) tourism – we are going to spend some time talking about Diabetes in a series of posts.

In my role as a nurse practitioner, I became surprisingly familiar with diabetes.  I say surprisingly because as an acute care nurse practitioner specializing in surgery, I never expected to have to fill the role of family doctor or family practitioner.  However, the prevalence of diabetes in this country (USA) is so incredibly pervasive, particularly undiagnosed diabetes – that every health care provider should become well-versed in the treatment of diabetes, and diabetes related conditions.

Diabetes = Coronary Artery Disease!

Working in heart surgery also means that patient education is critical for diabetics, particularly newly diagnosed diabetics[1].   Now one of the things that complicates the issue significantly is providers’ hesitancy to label people as “diabetics” due to insurance implications and all sorts of other issues.  So a lot of primary care providers are dancing around the issue, soft-pedaling the news and generally ignoring or under treating this disease.   As someone who treats the complications of these decisions everyday, (heart attacks, ischemic limbs, infections, etc.) I vehemently disagree with this strategy.

 How can I get my patient to take this seriously, and treat their diabetes aggressively, if I don’t?

Some of the things we need to do to treat Diabetes effectively are:

1. To detect it (estimates place the number of undiagnosed Americans at greater than 17 million people)

The best way to detect Diabetes is to use the newer generation of tests, specifically the hemoglobin A1c.  This test looks at the average glucose levels over several months.  This helps to rule out false elevations from acute illness, injury or surgery.  It also prevents under diagnosing from the tendency to ‘ignore’ one or two abnormal glucose readings.  “Oh, his glucose was 160; we’ll check it again in three months.”  That’s three more months that the patient goes untreated.  (Despite being abnormal, many of the older guidelines ignore readings of less than 180, and require two or more readings for diagnosis.  (Normal glucose is 70 -105 or 110, depending on source.)

2.   To treat it – using SAFE and effective medications.

Many people would be surprised to know that the best drugs for treating Diabetes are the older (cheaper) medications such as metformin (Glucophage) which has been used since 1977.  It’s readily available on many $4.00 pharmacy plans.

Many of the newer, fancier drugs (Avandia is the best known) have been linked to serious complications such as myocardial infarctions (or heart attacks).  Many of the other new drugs have no side benefits[2].  A good prescriber finds the best combination of medications to have the most beneficial effects, limited negative side effects and is cost effective.  Why treat five problems with twenty drugs (expensive with multiple drug interactions) when you can do it with four medications?

3. Finally – and most importantly, lets do more to prevent it.  Let’s all stop soft pedaling, and speak frankly and truthfully with our patients.  Diabetes is a horrible disease, so let’s stop pretending it isn’t.

Instead of trying to be the good, likable provider who turns a blind eye to health destroying behaviors – we need to be direct, and address these issues.  A glucose of 200 isn’t ‘good enough’.  Testing glucose once in a while isn’t ‘good enough’.    You may not like me when I tell you to absolutely, completely stop drinking soft drinks[3] (NEVER drink another soft drink), or to get out and start walking, (or a myriad of other things we’ll talk about) but if that helps reduce your risk of diabetes, prevents diabetic complications and ultimately lengthens and improves your quality of life – then that is a trade-off I am willing to make.

[1] In my previous practice, all patients had a hemoglobin A1c as part of their pre-operative laboratory work-up.  Up to 25% of the patients having heart surgery were found to have elevated A1c levels, and were undiagnosed diabetics.

[2] Just as medications have side effects – many drugs such as metformin have side benefits.   One of the side benefits of metformin is the protective blood vessel effect – patients that take metformin have fewer amputations than patients on other anti-diabetic drugs. Metformin has also been shown to be an important tool in the treatment of certain cancers.  Several research studies show that the use of metformin has been linked to decreased tumor growth in breast cancers.

[3] I am planning for a future article to discuss this in-depth, and present the research.  Please contact me if there is other Diabetes related content you would like to see.

Interview with Sanivisit in Reston, Virginia

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This morning I met with executives from Sanivisit, a new medical tourism company based here in Reston, Virginia.  This company is affiliated with the Colsanitas corporation in Bogotá, Colombia.

I met with Mr. Alberto Ospina, a native Bogotano and President of Sanivisit and his colleague, Ms. Monica Wainbarg, Medical Tourism Advisor.  Both of them were very gracious and interested in this project.

I was surprised and pleased to see that both of these individuals have certainly done their homework.  In this past, I have had mixed experiences with medical tourism companies.  Some have been excellent, but others like the LaMontes, (interviewed for Cartagena surgery project) were blatant opportunists with little understanding or caring about the specialized needs of the medical tourist.

This was not the case with Sanivisit.  Both of the executives I met with have personally visited and met with all of the physicians involved.  They have toured and inspected travel facilities, and have arranged for VIP services for their clients.  As Mr. Ospina explained, “I’ve been in every hotel, measured the rooms, talked to the staff.  I make sure that rooms are clean, and comfortable.  I make sure that there is room for wheelchair accessibility. I talk to everyone. I make sure that everyone involved knows what we are doing.”

This includes arranging for transportation, diagnostic testing, doctors appointments, private nursing care after surgery, and even physician house calls, if needed.

Right now, they are trying to get the Colsanitas hospitals included in some of the medical tourism pilot projects (as alternatives to India) with several health insurance companies.  As readers know, several other large health insurance companies already support and encourage medical tourism excursions, and have establish separate divisions to assist medical tourism efforts.  (Unfortunately, in many cases these divisions exclusively work with Indian hospitals.  As we’ve discussed at Cartagena Surgery on multiple occasions, and published elsewhere on-line – India is a less than ideal location for American patients for several reasons.)

Since the company is in its infancy. the next year will be the trial by fire for Colombian medical tourism, Sanivisit and Colsanitas.  They seem like genuine, and caring individuals.  I wish them the best of luck.

In the future, I hope to interview some of their returning clients for readers here – to get their perspectives and experiences.

Disclosure: 

For the sake of absolute transparency and honesty, I would like to disclose that I have offered several of my articles on Medical tourism to Sanivisit for their use (with no compensation or remuneration.)

Update: October 2011

Sanivisit participates in medical tourism conference

Patient Safety & Medical Tourism

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I’ve posted a link to an article talking about patient safety, and facility/ physician oversight in foreign medical facilities for patients seeking medical tourism options.

This is the rationale and purpose behind the both the Cartagena and the upcoming Bogotá books – that as an independent, unbiased reviewer and health care professional; I am able to observe, interview and evaluate facilities, surgeons and procedures for safety issues (and adherence to accepted national and international standards / protocols.)

This eliminates the uncertainty for patients seeking medical tourism; is the facility clean?  Are the physicians licensed?  Are the procedures performed according to accepted practices?

As a reputable, practicing health care provider with no secondary gain (other than book sales), patients can find a trustworthy source for this information.   I don’t work for the surgeons, the medical tourism companies or the governments of the host countries.  I don’t make a dime from these medical procedures – and have no vested interest in where patients ultimately seek care.

But, the development of infections, post-operative complications or other problems with medical tourism is bad for business (for the providers and facilities reviewed) so these facilities had a vested interest in letting me into their hospitals and their operating rooms.  They wanted me to see what they had to offer – particularly the facilities that are doing everything right..

(The facilities that weren’t following accepted practices invited me in, as well.  I think because they assumed that an American nurse wouldn’t know any better.)  That’s their oversight, and to your benefit – because I was able to observe and report my findings to you, my readers.

I think this is going to become a more popular and frequent practice – but hopefully the reviewers are going to be people like me; people familiar with the procedures and practices, and the operating room.  This is another separate issue – that has already reared its head.  There are several medical tourism books out there, including books that have made millions of dollars, written by arm-chair MBAs who looked at published statistics (only) and used this as the basis of their reports.. As everyone knows, published statistics are only part of the story, and can certainly be manipulated.

Physically viewing the facilities, talking to the surgeons and watching the procedures are the real test of how things function on a daily basis, and what care a patient should expect.

Friday, I am heading to Reston, Virginia to interview one of the people involved with the new Colsanitas medical tourism venture that we discussed in a previous post.  I’ve already been to the hospitals in Colombia (Clinica Colombia and Reina Sofia) and I’ve interviewed the surgeons involved, so I know the quality and care provided by the facilities involved.  But do they?  What rigor has this company performed to protect potential patients (and consumers of their services)?  In this case, I know that both the hospitals and the surgeons are excellent, but do they?  And how do they know this?   I’ll try to get answers to all of these questions and post them here for readers.

Medical Tourism in my own backyard..

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New agreement with Colsanitas and a company in Northern Virginia is bringing Colombia to the author’s backyard..

Now, for more intimate details of the Bogotá Colsanitas facilities and the surgeons operating there – you’ll have to pick up a copy of Bogotá! The book is being reviewed right now, so we’re getting closer and closer to publication..

ProExport Replies to our inquiries..

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First, I would like to give my sincere thanks to Gabriel Amorocho, who sought me out to address my concerns regarding ProExport.  He then made a special effort to follow up with me and to get all of my questions answered.

Since I was unable to meet any of the ProExport representatives during my stay in Colombia – I submitted a list of questions for your information.  I am posting the questions and the official answers from ProExport here.

Questions and Answers with Erick Forero of ProExport:

1.     What do you anticipate for the future of medical tourism in
Colombia?

Thanks to the high quality level of our health services, as well as the efficiency of its administration and management, Colombia has become an international leader in the health services sector, with the United States, the Caribbean islands and Ecuador as its main
clients.  The plan moving forward is to continue strengthening the sector, as well positioning the country even more as a health destination.

In addition, Colombia is now going through an excellent moment on the subject. Colombian health institutions have reached worldwide acknowledgement thanks to its state of the art technology, qualified personnel, customized attention, excellent service-lead times and competitive pricing.

The sector is currently working very strong on accreditation activities. While the country has its own accreditation system, there are some institutions working on their accreditation from the Joint Commission International (JCI).

So far we have two accredited institutions and around 15 in the process to enter the United States’ market.

2. How is the government promoting Colombia as a medical tourism destination?

The Government chose the medical services exports sector as a world-class industry, on the basis of which the Ministry of Trade, Industry and Tourism is conducting its activities around
creating tools to facilitate and overcome certain barriers that have been identified in the health field.

The duty-free regulation arose from the fact that sufficient beds were not available. Thus, the duty-free zones will increase the capacity by over one-thousand.

Furthermore, as part of its exportation promotion activities, Proexport Colombia is working very hard on positioning the country abroad by participating in events and arranging fam-trips where we bring insurers and facilitators to display our technology, infrastructure and the clinics.

3.     What do you see as the advantages of medical tourism in Colombia for North American consumers?

There are several reasons why Colombia is a health-tourism destination: First of all, it stands out at Latin American level thanks to its research on scientific and health topics; it has
established itself as an annual host for prestigious academic events, conventions, seminars and health training sessions; in addition to being pioneers in Latin America on the creation of its own health-accreditation systems (a total of 16 institutions have national accreditation and two have JCI international accreditation).

Colombia ranks first in Latin America in overall health system performance, and 22 in the world, according to the World Health Organization (WHO).

On the other hand, significant advancements have been made in the country as contributions to the medical world, such as the creation of the pacemaker (useful for certain heart
diseases), the Hakim valve (created to treat brain diseases) and the Malaria vaccination (a tropical disease that causes serious health problems in the region), among others.

Because of this, and thanks to the firm commitment to always guarantee the highest quality standards of health services, Colombia is one of the most attractive destinations world-wide for
health tourism.

4. I know Colombia has regulations in place restricting organ transplantation in Colombia to prevent black market sales.  Can you tell me more about that?

This is not a competency of Proexport Colombia. There is a regulation in place to give priority to national patients for transplants. The entity in charge is the National Health Institute. Its web
page is www.ins.gov.co.

5. Is Colombia planning to be represented at the Medical Tourism Association Congress in Chicago this October?

Who will be representing Colombia, and what will they be presenting?

We will be at the Convention in Chicago. The Colombian representation will be led by 10 institutions from the whole country. Proexport Colombia will coordinate the entire participation, thus we will have a stand with information regarding the country and four of
the participating clinics, which are all accredited and will have a stand. The best of the best from the country is going to be present at the event. They will be presenting their services, their export offer and the progress made in matters of infrastructure and technology acquisition.

6.    Is there anything specific you would like to pass along to Americans considering coming to Colombia for surgical procedures?

The offering found in Colombia by the foreign visitors coming to the country seeking these services is varied; however, the main sectors sought after are Cardiology, Cancer treatments,
Ophthalmology, Orthopedics, Dentistry, medical check-ups and plastic surgery.

Amongst the sales channels identified by Proexport, the entity in charge of exports, investment and tourism promotion in Colombia, we have the end user, insurers, facilitators and foreign doctors.

However, the arrival of new visitors into the country seeking these services is due to the various international conferences and conventions which take place, web-page promotions, insurer and
facilitator Fam Trips.

Bogota and Medellin are the main destinations for foreigners, followed by Bucaramanga, Cali, Santa Marta, Barranquilla, Cartagena and the Coffee Triangle.

Colombian Doctors are very experienced, and the majority of them have been educated in universities abroad.

We also have state-of-the-art technology and a one of a kind diversity of climates all year round, which is great for all patients.

In addition, thanks to our economy and exchange rates, we are very favorable in terms of costs, considering that health services are very costly and slow in other countries, while the opposite
occurs in Colombia.

Furthermore, we have good air-traffic connections with the United States.

7.      Can you explain the medical visa to me? Is a medical visa needed?

This is Foreign-Affairs Ministry issue.  But Colombia does not require a medical visa. If the treatment is a very lengthy one, lasting over six months, you must request a visa.

Thanks again, Mr. Amorocho, and Thanks, ProExport Colombia.

Bogota surgeons stay ahead of the curve

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As we’ve seen several times before, Bogotá surgeons stay ahead of the curve on cutting edge treatments.  In the last several weeks, HIPEC or Hyperthermic intraperitoneal chemotherapy (Sugarbaker procedure) has been dotting the news headlines in the United States, and across the globe.

But as my readers here at Bogotá Surgery know, not only have we talked about HIPEC in the past – Dr. Arias has been performing this procedure at Fundacion Santa Fe de Bogota since 2009.  He reports he did eight cases in May alone.  (This is considered fairly high volume if you review the amount of cases being done at other centers.)

Planning to catch up with Dr. Arias and check in later this summer..

American Hospitals get into the act: Bariatric Surgery

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After recent changes in the recommendations for the treatment of obesity and diabetes supporting the use of surgery (as previously discussed here) American hospitals have begun aggressively campaigning for medical tourists.. Several hospitals in Tennessee have created Bariatric programs to steer interested patients to their clinics – and in some cases are using TennCare dollars to do so. (TennCare is the Tennessee medicare program – which has been plagued with problems since it’s inception.)

With the FDA lowering the BMI restrictions for Lap-band procedures in particular, this procedure which is often marketed as the ‘easy bariatric surgery’ has taken off in popularity.  This is concerning since much of the research shows this device to be limited in effectiveness, particularly in the treatment of diabetes.

These BMI restrictions which were reduced from a BMI of 35 (with diabetes)  down to 30 can also be viewed as a government endorsement of the Lap-Band device since similar recommendations regarding the more definitive procedures such as Roux-en-Y have not been addressed.  It looks like a double win for this private company (Allergan) as the FDA prepares to approve this device for use in teenagers as young as 14, despite criticisms from the medical community.

Now in the past, I have strongly advocated for better and more aggressive treatment recommendations for diabetes and morbid obesity – but I have also believe in following the scientific data and research findings – which just don’t seem to support Lap-Banding for permanent / effective weight loss or blood sugar reductions.  Like we’ve seen several times before, these ‘easy’ quick fix solutions to try to take short cuts around surgery don’t always work – and in the end, you end off worse off then someone who didn’t have any procedures at all.  If patients want effective solutions to real problems – we should give it to them.  But we need to stop candy coating the risks and dangers, and hard selling devices, and give patients the actual facts.

I’d also like to recommend that interested readers sign up for Medscape.com accounts – it’s free and they have an entire section devoted to obesity/ diabetes/ bariatric procedures that highlights all of the research related to different procedures, and treatments.  I try to re-post when I can but it’s difficult for lengthy articles.

In that spirit – I have re-posted the latest gastric bypass article from Heartwire below.  (Interesting commentary that heartwire has a bariatric surgery section now.) It’s another Reed Miller report dated May 2, 2011:

Gastric Bypass Does More than Reduce Weight

April 29, 2011 (New York, NY) — Gastric-bypass surgery may provide benefits to patients with type 2 diabetes beyond the benefits that can be directly attributed to weight loss, a new study finds [1].

According to Dr Blandine Laferrère (St Luke’s Roosevelt Hospital, New York, NY) and colleagues, recent studies that show a strong correlation between the concentrations of plasma branched-chain amino acids (BCAAs) and related metabolites with insulin resistance and loss of insulin sensitivity raise the possibility that the rapid remission of diabetes seen in many diabetic patients after gastric-bypass surgery may be related to the pronounced changes in BCAAs or other metabolites and not the weight loss alone.

In a study published in the April 27, 2011 issue of Science Translational Medicine, Laferrère et al found the total amino acids and BCAAs decreased in the gastric bypass surgery group but not in a similar group of patients who lost the same amount of weight (10 kg) with diet alone. Also, the metabolites derived from BCAA oxidation decreased only in the surgery group. Levels of acylcarnitines and BCAAs and their metabolites were inversely correlated with proinsulin concentrations, C-peptide response to oral glucose, and the insulin-sensitivity index after weight loss, whereas the BCAAs and their metabolites were uniquely correlated with levels of insulin resistance.

These data suggest that the enhanced decrease in circulating amino acids that follows weight loss after gastric-bypass surgery is caused by a mechanism other than weight loss and may be related to why gastric-bypass patients often show more rapid improvement in glucose homeostasis than similar patients who lose weight without surgery, Laferrère et al conclude. However, the authors caution, “Whether the decrease in these metabolites and the implied activation of fuel oxidation is a cause or consequence of the diabetes remission after gastric bypass remains to be determined. . . . Future studies will further characterize the pathways involved in these metabolic alterations and will seek to understand whether the specific metabolic signature of [gastric-bypass surgery] is related to changes in gut peptides after surgery.”

In an accompanying perspective [2], Drs Robert E Gerszten and Thomas J Wang (Harvard University, Boston, MA) agree that “further work is needed to establish whether the reduction in concentrations of circulating amino acids after weight loss is the cause or a consequence of improvements in insulin sensitivity.”

Circulating amino-acid concentrations are likely to be determined partly by genetics and partly by environmental and nutritional factors, they explain, so “dissecting these effects will require nutritional manipulation studies with a variety of amino acids to be conducted in human subjects, especially given the availability of profiling technologies that permit characterization of the molecular consequences of such interventions,” the editorialists state.”

To the multiple readers who emailed me for more bariatric surgery/ diabetes information – I usually post whenever new or interesting information gets published. If you send specific questions about procedures, indications or related matter – I will try and address it in a future post.

ProExport revisited

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Well, the book goes for final editing next week – and still no comment or response to my inquiries at ProExport Colombia.  The situation has me completely frustrated – as it’s a whole division of government supposed devoted to helping people like me – to encourage economic investment in Colombia. It’s not as if my inquires have fallen into a black hole – I’ve had numerous people contact ProExport on my behalf – so this silence isn’t an incidental bureaucratic oversight – it’s a deliberate manuever from Deisy Vargas – since she’s been contacted about this; both in phone calls and emails from my other contacts multiple, multiple times (as well as my own efforts.)

If I were President Santos, I’d investigate this department – and see what they are doing with all those federal funds.  Almost six months now trying to get a response from Deisy Vargas – and getting a lot of ringing phones (no voicemail), and unanswered emails.  Where are these people all day?  What are they doing all day since they certainly aren’t helping people like me?

First Book signing date!

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Getting ready to start the final editing process, so I can get the manuscript off to the printers.

I’ll be back in Bogotá  – at Authors Bookstore on Calle 70 No 5 -23 in August (August 18th).

I’d like to have an event here in Virginia but I am still working on the details.  I’ll post the dates and times when I have something scheduled.

New article on Yahoo!

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New article posted on Yahoo!  (associated content).  Most of you have heard me talk about the topic before – it’s usually one of the first questions I heard when interviewing surgeons down in Bogotá – but I wanted to publish something where the rest of the world could see it..  (Colombia as a destination for American medical tourists – five reasons why..)

Dr. Albert Klein

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Met with my not-so-hidden co-writer to go over our notes, and to start the editing process.  Dr. Klein has written all of the drug content (he’s a clinical pharmacist), and much of the Bogotá city chapter.  We’ll be getting together again this week to go over the book, in-depth and try to get a little closer to publication.  It’s the first time I’ve seen him since leaving Bogotá, so it was great to get together again.. Now it will be a lot coffee (and sushi – our brain food) until the book is finally complete.

Interview with Dr. Borraez, Bogota Bag: 27 years later

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One of my new articles on Dr. Borraez has been published to Yahoo! (associated content section) – it’s shared content with the site..  I’ve also written two other articles, one of original content, so I’ll let you know if they get published.  I thought it might get a little more exposure this way.  I’ve written this trio of articles for Yahoo! as a trial run, so we’ll see how it goes..

Note:  Due to recent changes at Yahoo! this article link has changed.  I have updated the link to the new article link. Please let me know if you have difficulty accessing this article.