I just read an interesting article in the Annals of Thoracic Surgery.
Unfortunately, the full-text article is not available for free – but I did find a nice article abstract (which I’ve posted below.) It confirms some of the previous discussions we’ve had here at Cartagena Surgery on the role of surgery in Aortic Stenosis, even in ‘elderly’ patients. [I put elderly in quotes since the definition can be fairly elastic depending on who is doing the judging.]
The article below is from Medscape.com
Aortic valve replacement in the elderly: the real life.
Langanay T; Flécher E; Fouquet O; Ruggieri VG; Tour Bde L; Félix C; Lelong B; Verhoye JP; Corbineau H; Leguerrier A Department of Cardiovascular and Thoracic Surgery, University Hospital, Rennes, France.
BACKGROUND: Aortic stenosis is of concern in the elderly. Although aortic valve replacement provides good long-term survival with functional improvement, many elderly patients are still not referred for surgery because of their age. Percutaneous aortic valve implantation offers an alternative to open-heart surgery. Concerns about the management of aortic valve stenosis in the elderly will be reviewed.
METHODS: We retrospectively analyzed 1,193 consecutive aortic valve replacements, performed in octogenarians since January 2000. A total of 657 patients (55%) had at least one associated comorbidity (eg, respiratory failure) and 381 (32%) associated coronary lesions. Valve replacement was the only procedure in 883 patients (74%), and was associated with coronary revascularization in 262 cases, or with another cardiac procedure in 48 patients.
RESULTS: Overall operative mortality was 6.9% (83 of 1,193 patients); 5.5% for single replacement and 11.5% if associated with coronary artery bypass surgery. Univariate and multivariate analyses identified 11 operative risk factors related to general status, cardiologic condition, and the procedure itself: older age (p< 0.015); respiratory failure (p <0.03); aortic regurgitation (p <0.001); emergency surgery (p <0.0029); New York Heart Association class IV (p < 0.0007); right heart failure (p < 0.03); atrial fibrillation (p < 0.04); impaired ejection fraction (p < 0.001); coronary disease (p < 0.01); redo surgery (p < 0.02); associated coronary revascularization (p < 0.008).
CONCLUSIONS: Today, valve replacement has acceptable low hospital mortality, even in the elderly. Thus, older patients should not be denied surgery due to their advanced age alone. Conventional surgery remains the gold standard treatment for aortic stenosis; the decision should be made on an individual basis. If several risk factors suggest very high-risk surgery, then percutaneous valve implantation should be considered instead.
In more disturbing news:
As predicted, the unproven ‘easy option’ of TAVI is now being pursued by more low-risk patients. These lower risk patients are people who should have been encouraged to undertake the more durable, safe and proven surgical therapy [Aortic Valve Replacement.] I guess this just shows how quickly those new recommendations [for patient protection and safety] were thrown out the window.
In this article (posted below) by Kurt Ullman at Medpage Today – German researchers discuss their preliminary findings and discuss the use in low risk patients.
The bar for transcatheter aortic valve implantation (TAVI) is dropping as more lower-risk patients are undergoing the procedure and their outcomes are favorable, a single-center study from Germany found. [Unfortunately – as we’ve seen so many times in the past, and as I am finding out while preparing this presentation on the Syntax trial – studies such as this can be quite deceiving – and LONG term data is needed. – Cartagena Surgery].
When stratified by quartiles based on enrollment date, Q1 patients had higher logistic EuroSCOREs, higher Society of Thoracic Surgeons (STS) scores, and higher median N-terminal pro-B-type natriuretic peptide levels compared with those enrolled later in Q4, noted Nicolo Piazza, MD, PhD, and colleagues from the German Heart Center in Munich.
Although there were significant decreases in 30-day and six-month mortality from Q1 to Q4 in the crude analysis, after adjustments for baseline characteristics, the significant differences disappeared (HR 0.29 for 30-day mortality and HR 0.67 for six-month mortality), according to the study published online in the Journal of the American College of Cardiology.
“These results suggest that underlying comorbidities play an important role in acute and intermediate-term survival after TAVI,” the researchers wrote.
The researchers noted anecdotal information suggesting a shift toward using TAVI in patients who are less sick than those enrolled in premarket trials. Additionally, the next wave of trials involving the CoreValve (Medtronic) and the Sapien XT (Edwards Lifesciences) devices will involve intermediate to high surgical risk patients, providing “yet another indication that TAVI is being directed at the treatment of lower and lower surgical risk patients,” Piazza and colleagues wrote. [There are significant ethical considerations here which seem to be ignored – similar to criticisms of the Syntax trial – Cartagena Surgery.]
A single-center French study of low-risk TAVI patients found the procedure to be safe in this population. The study was presented at the European Society of Cardiology meeting in Paris.
The impact on this shift in patient selection was uncertain, they said, prompting a retrospective review of 420 patients who underwent TAVI at their institution from June 2007 to June 2010.
The consensus that a patient was suitable for TAVI was derived from a team that comprised cardiologists, cardiac surgeons, and anesthesiologists. This team approach is exemplified by the recent announcement that the American College of Cardiology and the Society of Thoracic Surgeons will jointly sponsor a TAVI registry to monitor the safety and efficacy of the procedure as it rolls out in the U.S.
Patients received either the CoreValve or Sapien device, the latter of which was just approved for use in the U.S. based on the PARTNER trial. PARTNER found that TAVI was as good as surgery in high-risk patients with severe aortic stenosis. [‘as good as’ – ah.. another ‘non-inferiority’ study….. view with skepticism folks..]
Researchers divided patients into four quartiles of 105 patients each. Those in Q1 were seen earlier in the study time frame than those in Q4.
Compared with Q4, Q1 patients had higher EuroSCOREs (25.4% versus 17.8%, P<0.001), STS scores (7.1% versus 4.8%, P<0.001), and NT-proBNP levels (3,495 versus 1,730 ng/dL, P<0.046).
There were significantly less transfemoral access approaches from Q1 to Q4, with a concomitant rise in transapical approaches. There also were significantly less intubations moving from Q1 to Q4, and the use of contrast significantly decreased over time.
Researchers noted that transfemoral complications decreased by 17% from Q1 to Q4 (P=0.008), but found no significant differences in the rate of stroke or transient ischemic attack or the need for a permanent pacemaker.
However, there was a shift in the later quartiles toward the treatment of younger patients with fewer comorbidities and lower surgical risk scores, Piazza and colleagues wrote.
Univariable analysis for 30-day mortality showed it was associated with age, STS score, atrial fibrillation, previous heart surgery, and previous stroke (P<0.10).
The factors associated with six-month mortality were age, logistic EuroSCORE, STS score, left ventricular ejection fraction, atrial fibrillation, previous cardiac surgery, chronic obstructive pulmonary disease, and N-terminal pro-B type natriuretic peptide (P<0.10).
Because only baseline characteristics were included, the authors noted the possibility that procedure-, operator-, or device-related factors might influence both 30-day and six-month mortality. The study is also limited by potential unmeasured confounding.
The investigators cautioned that little is known of the long-term durability of these devices should they be routinely implanted in younger patients with a longer expected life span. [especially since the lifespan of the patients these valves were designed for was six months to one year..]
Piazza is a consultant and proctor for Medtronic and CardiAQ. Other authors revealed consultant status with Medtronic and Edwards Lifesciences, or instuctors for Medtronic