Tuesday – We drove back from Cartagena this morning before heading to surgery in the afternoon for a bypass grafting case. For the first half of the way, I sat in the back and enjoyed looking out the window. It’s amazing how dry parts of Bolivar are.
The drought has been responsible for the deaths of over 20,000 farm animals here in Colombia. The small lakes are disappearing, from my first trip to Sincelejo to my most recent visit just a few weeks later. The trees and bushes besides the roadways are completely coated with layers of dust from passing vehicles. It gets greener as we pass into Sucre, but it’s a sad reminder of the devastating effects of climate change.
After stopping for breakfast along the way, where we met up with Dr. Melano, Iris went with Dr. Melano and I stayed with Dr. Barbosa. We talked about music mostly. At one point, a former patient from several years ago called, just to say hello. The patient had recently heard that Dr. Barbosa now had a surgery program in Sucre. (The patient had previously traveled to Cartagena from a small town in Sucre for surgery.)
Once we got to Sincelejo, we headed to the hospital to see our patient before surgery and go over any last-minute questions or concerns.
(Of course) I was worried about finding vein but we easily found good quality conduit. Dr. Salgua has been very nice about helping me with the saphenectomies. The team teases me because I have a difficult time pronouncing her name. We have a kind of system: While I finish closing the leg, she moves up the table to assist the surgeon in starting the grafts. Then when I finish wrapping the leg, I stay at the back of the table with the instrumentadora, learning the Spanish names for all the instruments. Once the chest is closed, she does a layer of fascia and I close the skin incision.
It’s a little crowded sometimes with the new instrumentadora learning the essentials of cardiac surgery, but the atmosphere at the back of the table is a lot different from the climate at the top. (Dr. B is always calm, pleasant and entertaining – but Dr. Salgua is almost completely silent the whole time). I am a lot quieter than my “out of OR self” when I am across the table from the surgeon too..
Wednesday – Another coronary case, on a fragile-ish patient (multiple co-morbidities including chronic kidney disease etc). It was a long case and I was a little worried the whole time but the patient did well. (I always worry about the frail patients).
I did okay too – performing a saphenectomy with Dr. Barbosa. The patient had a vein stripping procedure previously (on one leg only) so I wanted to be sure to get a good segment of vein on the remaining vein. I think Dr. Barbosa was worried about the quality of the conduit (because he kind of hovered – and didn’t relax until we started harvesting it.)
Skip harvesting
I wish I would have more opportunities to perform a traditional saphenectomy (one very long incision). I assisted on one several years ago – and I think if I had a chance to do a couple more, I would feel more comfortable skip harvesting. Of course, a headlamp would also help. (It’s kind of dark looking down the skip ‘tunnels’). Then once I’ve mastered skip harvesting, I think it’s just another small jump to endo-harvesting with a scope. I know a lot of people never bother learn to skip harvest, but I feel more comfortable building on the principles of open procedures first. I might need them in an emergency case which is kind of why I wished I had more open saphenectomy experience.
Thursday – Saw three patients in the clinic today. However, on reviewing the patient records and an intra-office echocardiogram, one of the patients definitely doesn’t need surgery at this point. (Asymptomatic with only moderate valvular disease). We were happy to let him know he didn’t need surgery even if that means fewer cases.
Two surgeries today. The first case was a bypass case for a patient with severe coronary disease and unstable angina. Dr. Salgua and I did the harvest. I think Dr. Barbosa is a little nervous about handing over the reins to me for harvest because he keeps a pretty close eye on me while I am doing it. But then again, it might be because I am a little overly cautious and hesitant at this point. If I didn’t have Dr. Salgua to look over my shoulder and encourage me onward, I’d put clips on everything and proceed at a snail’s pace to make sure I do it right. But since it’s still my first week, maybe I shouldn’t be so hard on myself.
On the other hand, he must think my suturing is pretty good, because he just trusts me to do it correctly.
The second case was a patient from last week, who developed a large (symptomatic) pleural effusion and cardiac effusion (no tamponade or hemodynamic instability) which is a pretty common surgical complication. The case proceeded well – I placed the chest tube, with Dr. Barbosa supervising. Dr. Barbosa performed the cardiac window portion of the procedure.
Sadly, one of our patients from last week died today. It was a fragile patient to begin with, and even though surgery proceeded well, the patient could never tolerate extubation and had to be re-intubated twice after initially doing well. From there, the patient continued to deteriorate.
Friday
Today we had a beautiful aortic valve surgery. This has always been one of my favorite cardiac procedures. Somehow its elegant in the way the new valve slides down the carefully coördinated sutures. (I don’t have pictures from this case – since I was first assisting – but I will post some from a previous case – so you can see what I mean).
Dr. Salgua worked an overnight shift, so I was at the top of the table – (and yes, noticeably quieter than normal.) I was surprised at how fast it seemed to go – but maybe that’s because everything went so smoothly. Or maybe because we’ve done a lot of coronaries lately, which is a much more tedious and time-consuming process.
Iris and I are working on a patient education process – as a way to improve the continuum of care for patients (particularly after discharge). I really enjoy working with Iris because I feel like we are always on the same page when it comes to patient care.
While it’s been a tiring week for the crew – I am, as always! exhilarated and happy to be here in Sincelejo. Just knowing it’s the end of another week (and I am that much closer to going home) has me feeling a little sad. But I guess I can’t stay forever, and I sure don’t want to take advantage of all the kindnesses that have been extended to me.
That being said:
At the end of every surgery, every day and every week in Sincelejo – I am grateful. Grateful to Dr. Barbosa for being such a willing and patient teacher – grateful to the operating room crew (especially Iris Castro and Dr. Salgua) and particularly grateful to all the kind and generous patients I have met and helped take care of*.
The medical mission
This week I had another inquiry about ‘medical missions’. I know people mean well when they ask about medical missions, or when they participate in these types of activities but…
Long time readers know my philosophy on this – don’t go overseas so you can pat yourself on the back over the ‘great deeds’ you performed ‘helping the poor’. It’s patronizing to the destination country and its inhabitants – and generally not very useful anyway. An awful lot of volunteers with real skills and talents go to waste on these so-called mission trips when their skills might be better served (in less exciting or glamorous ways) in free clinics in our own country.
But it does give everyone involved a chance to brag about how selfless and noble they have been; traveling thousands of miles, sleeping somewhere without 24/7 wi-fi (and who knows what other hardships).
Instead, change your orientation – and maybe challenge that assumption that everything you’ve learned about medicine, health care and taking care of people is better and superior. Open your eyes and be willing to learn what others have to teach you instead.
* I always opt for full disclosure and transparency with the patients. I introduce myself and explain that I am a studying with Dr. Barbosa, what my credentials and experience is to give them the opportunity to ‘opt out’.
Here in Cartagena, I have been fortunate enough to have two great roommates; Iris and Ximena.
Dr. Barbosa made all the arrangements for me, and I was a little nervous about bunking down with another nurse (we can be temperamental and territorial at times) but living with Iris has been absolutely wonderful.
I was kind of worried I’d be living with some young, possibly flighty nurse who might resent having a middle-age woman in her home, cramping her style. Instead, it’s like having an instant best friend and I love it.
For starters – we have a lot in common: we are both academically and professionally inclined. Iris is the perfusionist for Dr. Barbosa’s cardiac surgery service and is extremely knowledgeable.
Part of the machinery that makes up Iriis’ professional life: the heart-lung machine
(In Colombia, Perfusion is an advanced nursing degree. Iris obtained her master’s degrees in both critical care (National University) and Perfusion at (CES.). She is widely acknowledged as one of the best perfusionists (if not the best) in all of Colombia. Her peers frequently consult her seeking advice for a variety of surgical circumstances.
She is the only nurse to collaborate (and be listed on the cover) of a comprehensive Colombian textbook on Cardiology. Her name is listed along side such esteemed Colombian physicians as Pablo Guerra, Nestor Sandoval and Sergio Franco.
She also serves as a reviewing editor of several Colombian medical journals. Research articles are sent to Iris to review the methodology/ study design and overall quality. Articles she rejects will not be accepted for publication.
In her free time, it’s not unusual to find her reading the latest journal articles on cardiac surgery or working on presentations for the latest meeting or international conference on perfusion. In fact, she recently returned from the annual Colombian conference on cardiology and cardiac surgery in Medellin. She is equally enthusiastic about all aspects of nursing and the position and rights of women (nurses) in Colombia and in medical society in general.
She is particularly outspoken against much of the machismo that dominates life here. She is the one person I have learned to expect to never ask me the unpleasantly intrusive questions that seem to pass for almost introductory conversation here such as “Why don’t you have children? Don’t you want them? What does your husband think of that? Your husband permits you to be here [in Colombia] without him?”*
Even when we don’t agree on all issues, she never judges my opinions or thoughts. She endeavors to understand my reasoning instead. It’s refreshing.
This combination of intellect, insight and experience makes for a lot of interesting and engaging discussions in the evenings as we relax and enjoy the fragrant breezes that bring daily relief to the sweltering city.
A strong woman in a culture of machismo
Iris is also extremely forthright and independent (traits that also resonate with me.) She takes no ‘guff’ from anyone and lives how she pleases in a society that has a lot of difficulty accepting that (unmarried, no kids with Ximena as a part-time roommate.)
Even my professor, as charming and intelligent as he is, defaults into this kind of ‘macho’ thinking. He tells me he worries about Iris, as “she is all alone” without a man to protect her. He worries she is missing out on true happiness and is destined to be sad, alone. Nothing could be further from the truth.
Rather, Iris has chosen to defy tradition, and live life on her terms. She has friends, family and romantic attachments like anyone else. She just maintains both her privacy and her independence despite that, sort of like Elizabeth I of England.
It is sometimes hard as an outsider to understand why this attracts some much attention – a single woman living quietly in her own apartment. But then I think back to some of the comments I get from friends, acquaintances, co-workers and even strangers regarding locums life, and I realize, that as female professionals; whether the United States or Colombia, we still have a long way to go.
It’s just that as an American, I think I have fallen for the illusion of the possibility of female equality in way that women in other countries never have. (The irony is that at this moment in my home country, women’s rights; to reproductive, financial and professional freedom are being eroded more that any other time in recent history. Hard won battles of the 60’s and 70’s are being erased with nary an outcry.)
Here ‘paternalism’ rules the day – and no one pretends any different.
But there is more to Iris that a forthright, intelligent, independent individual. She is also a nurturer, a caregiver, a nurse in the very sense of the word.
What could be more nurturing that offering up her home to an unknown stranger from another land?
“Ximena”
Iris and the other members of her apartment complex have adopted a white and orange stray cat that answers to a variety of affectionate terms. One of these is “Nena”. One my first day here, I confused “Nena” as a shortened version of Ximena, so Ximena she is.
This straggly looking, mangy little ball of fluff is adored by the residents of the small apartment building. Typical of most cats, she is “owned” by none, but owns each neighbor in turn. But it was Iris who took up donations to get Ximena surgery she needed and routine veterinary care. All the residents share in the feeding and care of the street cat – including applying a cream to her healing surgical scar, but it is Iris whom Ximena usually seeks.
While most of the residents leave their doors open during the afternoons to invite Ximena in, Ximena is most often found either inside our apartment, or bellowing outside the door (on the rare occasions that is is closed.) She wanders in with the grace and arrogance that only a cat possesses.
She carries herself with a dignity that belies her ‘homeless’ state as to say she isn’t a vagabond but a seasoned traveler as she visits each apartment in turn – but always comes back to Iris to stay all afternoon and overnight.
Some of the neighbors our jealous of Ximena’s attention, but with our weekly journeys to Sincelejo, they always have an apportunity to host ‘Nena as their favored guest.
Iris loves to cook – and does so easily, deliciously. She embraces a healthy lifestyle filled with daily exercise and fresh fruit and vegetables.
salad made of exotic fruits
We talk about my love of Colombian food – and together one day in the kitchen, we make brevas. She tells me with a smile that she has never made them, but used to watch her grandmother cook them for a sweet tweet.
Boiling brevas: Photo by Camila
We savor the sugary treat, one breva at a time over the next several days.
In addition to learning how to perform saphenectomies from Dr. Barbosa, Iris is teaching me how to crochet. My first project will be one of the small bags that is in a style typical for Colombia. I think it is ironic that it seems easier to suture that it is to crochet.
But Iris is endlessly patient with me – and slowly, slowly as I unravel my mistakes and start again, I am making progress. She has a blogspot where she showcases her latest creations. She recently received national accreditation as a ‘native artist’ to participate in festivals and art fairs that specialize in traditional Colombia crafts.
Today, as we sit on the sofa, crocheting, we talk about plans for the Semana Santa (Easter Week). The secretarial staff in Sincelejo has vacation plans and wants to keep the office closed all week so she can visit a boyfriend in Medellin – but Iris and I think it should remain open for the patients. We plan to offer to staff the office, so that patients won’t have to wait a week to be seen. We will have to navigate and negotiate carefully and diplomatically to prevent causing any hard feelings but as Iris points out, it’s the right thing to do for the patients – and the doctors, and that’s what matters. (My motives are admittedly more self-serving: more clinic = more surgery.)
*This type of questioning is fairly pervasive throughout Colombia, and is often performed as part of introductory conversation. Once a taxi driver in Bogotá directed me to the nearest fertility clinic when I responded “No” to the question about children. He wasn’t rude, on the contrary, he thought he was being helpful.
If there is such thing as a perfect day, it would have been today. The weather was still hot, humid and sticky. I still have student loans and the world continues to have accidents, disasters and wars. But for me, today was as good as it gets.
I spent the morning in the operating room while Dr. Barbosa performed a septal patch, and repair of the tricuspid valve. The case went well and the patient did beautifully. Before I left the hospital, the patient was already awake, alert and awaiting extubation. There was no hemodynamic instability or bleeding.
The local cardiologist did several cardiac catheterizations today – and we were consulted on four of them. 3 of the patients have excellent targets for bypass grafts and normal heart function. The fourth patient is a little more fragile, but is still a reasonable candidate for surgery.
Best way to see Sincelejo: On the back of a bike*
Lastly, I spent a nice, breezy hour touring the city on the back of a friend’s motorcycle. (Yes, mom – I wore my helmet – and he didn’t drive like a maniac.) We went all over Sincelejo; from the scenic overlook over the valley below, to the football stadium, past the University of the Caribbean, over to a public park with tennis courts, several pools and a small zoo. (I don’t have any pictures because I figured I’d probably drop it).
My guide was Omar, the spouse of my friend, Elena. He works in the Parks & Recreation department of the Sucre.
After returning home, I took a walk down to the Plaza to buy some local cheese. Then I spent the evening eating exotic fruits like guama, plums, uchuvas and fejoas.
Dr. Sergio Franco wrote the book on heart surgery.
It was exciting and illuminating to talk to Dr. Sergio Franco, who is one of Colombia’s most prolific writers and professors of cardiac surgery. The 50 year-old cardiac surgeon has authored multiple textbooks for surgeons and edited ten others, making him one of the nation’s definitive experts on cardiac surgery.
Dr. Franco stands near a collection of his textbooks
Currently he is the Medical Director of the Cardiopulmonary and Peripheral Vascular Center of the Fundacion San Vicente in Rio Negro, as well as Chief of Cardiothoracic Surgery at the Clinica de Medellin. For the last 12 years, he has also been the program director for post-graduate studies at the Universidad CES medical school. Between the two clinics, and the five other surgeons he works with (2 at Clinica de Medellin and 2 at Rionegro), he estimates that the cardiac programs see volumes of 700 – 750 cases per year.
For our first interview, we meet at the Clinica de Medellin to talk. He later invites me to see the hospital at Rionegro.
Education/ Training / Experience
Dr. Franco attended medical school, general surgery residency and cardiac surgery fellowship at the Universidad Pontifica Boliviarana. He finished his fellowship in 1996. As part of his fellowship, he spent nine months training in heart and lung transplantation at Loyola University Medical Center in Chicago, Il. During his heart and lung tranplantation training, he received an award as “Best Foreign Medical Fellow.” He graduated with high honors due to his exemplary grade point average.
He has additional training in thoracic and thoracoabdominal aortic surgery (Missouri Baptist, 1998), and minimally invasive valvular surgery (Cleveland Clinic).
Selected awards and special recognition
He was also the first surgeon to perform endovascular harvesting of the saphenous vein in Colombia in 1997. He received second place for a poster presentation based on this technique at the Colombian Congress of Cardiology and Cardiovascular Surgery, Cartagena, 8 to 11 February 2006.
He received the Cesar Uribe Piedrahita Medal from the Colombian Medical Federation and the Antioquia Medical College in 2003 for academic and clinical excellence, in addition to several other awards for academic achievement.
He was the chapter president of the Colombian Society of Cardiovascular Surgery and the Colombian Surgical Consensus for multiple terms. He was also the Chairman, and Medical Advisory of the first Latin American Forums on cardiovascular surgery.
He has received several awards including “The best of 2006” from Hospital General de Medellin for his assistance in the development, creation and commissioning of the cardiovascular services unit at that facility. He has also presented his work at numerous national and international conferences.
He speaks English in addition to his native Spanish.
Dr Sergio Franco
San Vicente Fundacion
Cardiovascular Surgery
Medical Director, Cardiopulmonary and Vascular Surgery
While I requested a visit to the operating room, an invitation was not forthcoming.
Selected writings of Dr. Sergio Franco
Book chapters:
1. Franco S., Restrepo G. Momento Quirúrgico óptimo en el paciente con enfermedad valvular cardiaca. Libro Tópicos selectos en enfermedades cardiovasculares 2000. Unidad cardiovascular Clínica Medellín. 1 Edición. Página. 101-112. ISBN 958-33-1541-9
2. Franco S. Endocarditis Infecciosa: Visión Quirúrgica – Indicaciones de Cirugía. Libro Tópicos selectos en enfermedades cardiovasculares 2000. Unidad cardiovascular Clínica Medellín. 1 Edición. Páginas 201-211. ISBN 958-33-1541-9
3. Franco, S. Estenosis Mitral – Tratamiento Quirúrgico. En: Franco, S. (Ed) Enfermedad valvular cardiaca. Sociedad Colombiana de Cardiología. Editorial Colina, 1 edición, Pgnas 111-116 Abril 2001. ISBN : 958-33-2244-X
4. Franco, S., Giraldo, N. , Vélez JF. Uso e Indicaciones deHomoinjertos – Cirugía de Ross. En: Franco, S (Ed) Enfermedad Valvular Cardiaca. Sociedad Colombiana de Cardiología. Editorial Colina, 1 edición, Pgnas 70 – 77, Abril 2001. ISBN : 958-33-2244-X
5. Alzate L., Franco S. Factores hemodinámicos y físicos de las válvulas cardiacas artificiales. En: Franco, S. (Ed) Enfermedad Valvular Cardiaca – Sociedad Colombiana de Cardiología. Editorial Colina, 1 edición, Pgnas 222 – 228 Abril 2001. ISBN : 958-33-2244-X
6. Franco, S., Vélez, J. Revascularización Quirúrgica del Miocardio: Estado actual. En: Tópicos selectos en terapéutica cardiaca y vascular 2001. Cardiología Clínica Medellín. P: 108 –120. Primera edición, Octubre 2001. ISBN : 958-33-2607-0
7. Vélez, JF, Franco, S., Tamayo L. Tratamiento quirúrgico de la enfermedad coronaria. En: Enfermedad Coronaria. Pineda M, Matiz H, Rozo R. (Ed), septiembre 2002. Capitulo 36, pgnas 609-630. ISBN : 958-33-3945-8
8. Franco, S.Intervencion Quirúrgica de los síndromes coronarios agudos. En: Tópicos selectos en enfermedades cardiovasculares, 2002. Pgna 177-192 (Velásquez D, Uribe W, editores) Ed. Colina, Departamento de Cardiología Clínica Medellín 2002. ISBN 958-33-3663-7
9. Franco, S.Cardiopatías Congénitas del Adulto. En: Tópicos selectos en cardiología de consultorio 2003. Pgnas 193-211. (Restrepo G., Uribe W., Velásquez D., editores). Ed. Colina, Cardiología Clínica Medellín, 2003. ISBN : 958-33-4858-9
10. Franco, S.Enfermedad Valvular Cardiaca: Indicaciones de Cirugía. En: Libro II Congreso medicina cardiovascular y torácica. . Hospital Departamental Santa Sofía de Caldas, 2003 (Jaramillo O., Editor) Editorial Tizan. Pgnas 87-104
11. Franco, S.Tratamiento Quirúrgico de la Fibrilación Atrial. En: Libro II Congreso medicina cardiovascular y torácica. Hospital Departamental Santa Sofía de Caldas, 2003. (Jaramillo O., Editor) Editorial Tizan. Pgnas 123-131
14. Franco, S., Giraldo, N. Tratamiento Quirúrgico del Paciente Valvular en Falla Cardiaca. En: Enfermedad Valvular Cardiaca. Paginas 169 – 176. (Franco, S., Editor). Editorial Colina. Primera Edición 2004. 227 paginas. ISBN 958-33-6218-2
15. Franco, S. Jiménez A. Factores Físicos y Hemodinámicos de las Prótesis Valvulares Cardiacas. En: Enfermedad Valvular Cardiaca. Pgnas 223-227. (Franco, S., Editor). Editorial Colina. Primera Edición 2004. 227 paginas. ISBN 958-33-6218-2
16. Franco, S.Guías de manejo de las valvulopatias aorticas. En: Tópicos Selectos en Guías de Manejo en Enfermedades Cardiacas y Vasculares 2004. Pgnas 143-149. (Uribe, W, Velásquez D, Restrepo G., Editores). Editorial Colina. Primera edición, 2004. 195 paginas. ISBN 958-33-6285-9
17. Franco, S.Guías de manejo de las valvulopatias mitrales. En: Tópicos Selectos en Guías de Manejo en Enfermedades Cardiacas y Vasculares 2004. Pgnas 149-155. (Uribe, W, Velásquez D, Restrepo G., Editores). Editorial Colina. Primera edición, 2004. 195 paginas. ISBN 958-33-6285-9
18. Franco, S.Tratamiento Quirúrgico de la Fibrilación Atrial. En: Falla Cardiaca, Diagnostico y manejo Actual. 2004. Pgnas 271- 287.. (Castro, H; Cubides, C. Editores) Editorial Blanecolor, Primera edición, 2004. 431 pgnas. ISBN 33-6689-7
19. Escobar, A. Franco, S. Trauma de grandes vasos torácicos. En: Tópicos Selectos en guías de manejo en enfermedades cardiacas y vasculares – 2005. (Velásquez D., Uribe W. editores) 1 Edición, editorial colina, 2005. pgnas 160- 169. 193 paginas. ISBN : 958-33-7698-1
20. Franco, S., Vélez, A. Trauma cardiaco. En: Tópicos Selectos en guías de manejo en enfermedades cardiacas y vasculares – 2005. (Velásquez D., Uribe W. editores) 1 Edición, editorial colina, 2005. pgnas 154- 159. ISBN : 958-33-7698-1
21. Franco, S., Jaramillo, J. Tumores cardiacos. En: Tópicos Selectos en guías de manejo en enfermedades cardiacas y vasculares – 2005. (Velásquez D., Uribe W. editores) 1 Edición, editorial colina, 2005. pgnas 117 – 123. 193 paginas. ISBN : 958-33-7698-1
22. Franco, S., Vélez, A. Trauma cardiaco. En: Tópicos Selectos en guías de manejo en enfermedades cardiacas y vasculares – 2005. Manual Condensado. (Velásquez D., Uribe W. editores) 1 Edición, editorial colina, 2005. pgnas 362- 366. 388 paginas. ISBN : 958-33-7698-1
23. Franco, S.Guías de manejo de las valvulopatias aorticas. En: Tópicos Selectos en Guías de Manejo en Enfermedades Cardiacas y Vasculares 2005. Manual condensado. Pgnas 177-182. (Uribe, W, Velásquez D, Restrepo G., Editores). Editorial Colina. Primera edición, 2005. 388 paginas. ISBN : 958-33-7698-1
24. Franco, S.Guías de manejo de las valvulopatias mitrales. En: Tópicos Selectos en Guías de Manejo en Enfermedades Cardiacas y Vasculares 2005. Manual condensado. Pgnas 183-188. (Uribe, W, Velásquez D, Restrepo G., Editores). Editorial Colina. Primera edición, 2005. 388 paginas. ISBN : 958-33-7698-1
25. Jaramillo, J.S., Franco, S.Implante Quirúrgico del Electrodo Epicárdico en el Ventrículo Izquierdo Mediante Cirugía. En: Duque, M., Franco, S. Editores. Tratamiento no Farmacológico de la Falla Cardiaca. Sociedad Colombiana de Cardiología y Cirugía Cardiovascular. Primera Edición, Editorial Colina, Pgnas 89-92, Abril 2006. ISBN : 958-33-8661-8
26. Franco, S.Cirugía de Remodelación Ventricular en Falla Cardiaca. En: Duque, M., Franco, S. Editores. Tratamiento no Farmacológico de la Falla Cardiaca. Sociedad Colombiana de Cardiología y Cirugía Cardiovascular. Primera Edición, Editorial Colina, Pgnas 168 – 182, Abril 2006. ISBN : 958-33-8661-8
27. Jaramillo, JS., Franco, S., Vélez, JF. Revascularización Coronaria Quirúrgica. En: Velásquez, D., Restrepo, G., Duque, M., Uribe, W., Franco, S. Editores. Tópicos Selectos En Enfermedades Cardiacas y Vasculares – 2006, Estado del Arte. Primera Ed, 2006, Editorial Colina. Pgnas 559-576. ISBN : 958-33-9493-9
28. Franco, S., Vélez, JF, Jaramillo, JS., Cirugía en Enfermedad Valvular Aortica. En: Velásquez, D., Restrepo, G., Duque, M., Uribe, W., Franco, S. Editores. Tópicos Selectos En Enfermedades Cardiacas y Vasculares – 2006, Estado del Arte. Primera Ed, 2006, Editorial Colina. Pgnas 588 – 595. ISBN : 958-33-9493-9
29. Franco, S., Vélez, JF, Jaramillo, JS., Valvulopatia Mitral. En: Velásquez, D., Restrepo, G., Duque, M., Uribe, W., Franco, S. Editores. Tópicos Selectos En Enfermedades Cardiacas y Vasculares – 2006, Estado del Arte. Primera Ed, 2006, Editorial Colina. Pgnas 596 – 603. ISBN : 958-33-9493-9
30. Franco, S., Vélez, JF, Jaramillo, JS., Cirugía en Enfermedad Valvular Pulmonar y Tricúspidea. En: Velásquez, D., Restrepo, G., Duque, M., Uribe, W., Franco, S. Editores. Tópicos Selectos En Enfermedades Cardiacas y Vasculares – 2006, Estado del Arte. Primera Ed, 2006, Editorial Colina. Pgnas 604 – 606. ISBN : 958-33-9493-9
31. Jaramillo, JS., Franco, S., Vélez, JF, Disección Aortica. En: Velásquez, D., Restrepo, G., Duque, M., Uribe, W., Franco, S. Editores. Tópicos Selectos En Enfermedades Cardiacas y Vasculares – 2006, Estado del Arte. Primera Ed, 2006, Editorial Colina. Pgnas 607 – 617. ISBN : 958-33-9493-9
32. Franco, S., Vélez, A., Trauma de Corazón y Grandes Vasos. En: Velásquez, D., Restrepo, G., Duque, M., Uribe, W., Franco, S. Editores. Tópicos Selectos En Enfermedades Cardiacas y Vasculares – 2006, Estado del Arte. Primera Ed, 2006, Editorial Colina. Pgnas 618 – 625. ISBN : 958-33-9493-9
33. Franco, S., Jaramillo, JS., Vélez, JF., Tumores Cardiacos. En: Velásquez, D., Restrepo, G., Duque, M., Uribe, W., Franco, S. Editores. Tópicos Selectos En Enfermedades Cardiacas y Vasculares – 2006, Estado del Arte. Primera Ed, 2006, Editorial Colina. Pgnas 626 – 635. ISBN : 958-33-9493-9
34. Vélez, JF, Franco, S., Jaramillo, JS., Cardiopatías Congénitas del Adulto. En: Velásquez, D., Restrepo, G., Duque, M., Uribe, W., Franco, S. Editores. Tópicos Selectos En Enfermedades Cardiacas y Vasculares – 2006, Estado del Arte. Primera Ed, 2006, Editorial Colina. Pgnas 649 – 659. ISBN : 958-33-9493-9
35. Uribe, W., Franco, S., Gil, E. Fibrilacion Auricular. En: Velásquez, D., Restrepo, G., Duque, M., Uribe, W., Franco, S. Editores. Tópicos Selectos En Enfermedades Cardiacas y Vasculares – 2006, Estado del Arte. Primera Ed, 2006, Editorial Colina. Pgnas 441 – 466. ISBN : 958-33-9493-9
36. Restrepo, G., Franco, S.Endocarditis Infecciosa. En : Texto de Cardiologia. Sociedad Colombiana de Cardiologia y Cirugia Cardiovascular. Legis, S.A. 1 Ed, 2007; Capitulo VI, pgnas 614-30. ISBN : 958-97065-7-6
37. Franco, S., Sandoval, N. Tratamiento Quirurgico de la Fibrilacion Atrial. En : Texto de Cardiologia. Sociedad Colombiana de Cardiologia y Cirugia Cardiovascular. Legis, S.A. 1 Ed, 2007; Capitulo IX, pgnas 835-842. ISBN : 958-97065-7-6
38. Franco, S., Jaramillo JS. Trauma Cardiaco. En : Texto de Cardiologia. Sociedad Colombiana de Cardiologia y Cirugia Cardiovascular. Legis, S.A. 1 Ed, 2007; Capitulo XVI, pgnas 1442-49. ISBN : 958-97065-7-6
39. Franco, S., Velez, A. Trauma Vascular Cervical. En : Guias de Manejo en Enfermedades Cardiacas y Vasculares 2007. Manual Condensado, 3 Edicion, Cardiologia Clinica Medellin; 2007. Capitulo 31, P 425 – 433. ISBN : 979-958-98111-9-1
40. Franco, S., Velez, A., Jaramillo JS. Trauma Cardiaco. En : Guias de Manejo en Enfermedades Cardiacas y Vasculares 2007. Manual Condensado, 3 Edicion, Cardiologia Clinica Medellin; 2007. Capitulo 30, P 419 – 423. ISBN : 979-958-98111-9-1
41. Franco, S.Guias de Manejo de las Valvulopatias Aorticas. En : Guias de Manejo en Enfermedades Cardiacas y Vasculares 2007. Manual Condensado, 3 Edicion, Cardiologia Clinica Medellin; 2007. Capitulo 25, P 379 – 385. ISBN 978-958-98111-9-1
42. Franco, S.Guias de Manejo de las Valvulopatias Mitrales. En : Guias de Manejo en Enfermedades Cardiacas y Vasculares 2007. Manual Condensado, 3 Edicion, Cardiologia Clinica Medellin; 2007. Capitulo 26, P 387 – 392. ISBN : 979-958-98111-9-1
43. Jaramillo, J.S., Franco, S.Guias de Manejo de la Revascularizacion Coronaria Quirurgica. En : Guias de Manejo en Enfermedades Cardiacas y Vasculares 2007. Manual Condensado, 3 Edicion, Cardiologia Clinica Medellin. Capitulo 24, P 369 – 377. ISBN : 979-958-98111-9-1
44. Franco, S.; Velez, JF.; Jaramillo,JS. Complicaciones mecanicas del infarto agudo del miocardio. En : Topicos Selectos en Enfermedad Coronaria – 2008. Velasquez, D. ed; Distribuna Ed, Cardiologia Clinica Medellin, 2008. P. 115-126. ISBN 978-958-8379-09-8
45. Jaramillo,JS.; Franco, S.; Velez, JF. Guias de manejo de la revascularizacion coronaria quirurgica. En : Topicos Selectos en Enfermedad Coronaria – 2008. Velasquez, D. ed; Distribuna Ed, Cardiologia Clinica Medellin, 2008. P. 197- 218. ISBN 978-958-8379-09-8
46. Franco, S.; Jaramillo, J.S. Guías de Manejo de la revascularización Coronaria Quirúrgica. En: Guias de manejo en enfermedades cardiacas y vasculares. Manual Condensado 2009. Velásquez, D. Ed. Editorial Distribuna, 1 edicion 2009, 503 paginas. P. 429-440. ISBN : 978-958-8379-19-7
47. Franco, S.; Jaramillo, J.S. Guias de Manejo de las valvulopatias aorticas. En: Guias de manejo en enfermedades cardiacas y vasculares. Manual Condensado 2009. Velásquez, D. Ed. Editorial Distribuna, 1 edicion 2009, 503 paginas. P. 441-448. ISBN : 978-958-8379-19-7
48. Franco, S.; Jaramillo, J.S. Guias de Manejo de las valvulopatias mitrales. En: Guias de manejo en enfermedades cardiacas y vasculares. Manual Condensado 2009. Velásquez, D. Ed. Editorial Distribuna, 1 edicion 2009, 503 paginas. P. 449-456. ISBN : 978-958-8379-19-7
49. Franco, S.; Jaramillo, J.S. Trauma Cardiaco. En: Guías de manejo en enfermedades cardiacas y vasculares. Manual Condensado 2009. Velásquez, D. Ed. Editorial Distribuna, 1 edición 2009, 503 paginas. P. 487-492. ISBN : 978-958-8379-19-7
50. Franco, S.; Jaramillo, J.S. Trauma Vascular Cervical. En: Guías de manejo en enfermedades cardiacas y vasculares. Manual Condensado 2009. Velásquez, D. Ed. Editorial Distribuna, 1 edición 2009, 503 paginas. P. 493 – 503. ISBN : 978-958-8379-19-7
51. Franco, S.; Jaramillo, J.S. Trauma Vascular Cervical. En: Guías de manejo en enfermedades cardiacas y vasculares. Manual Condensado 2010. Velásquez, D. Ed. Editorial Distribuna, 2 edición 2010, 511 paginas. P. 501 – 511. ISBN : 978-958-8379-29-6
52. Franco, S.; Jaramillo, J.S. Trauma Cardiaco. En: Guías de manejo en enfermedades cardiacas y vasculares. Manual Condensado 2010. Velásquez, D. Ed. Editorial Distribuna, 2 edicion 2010, 511 paginas. P. 495 – 500. ISBN : 978-958-8379-29-6
53. Franco, S.; Jaramillo, J.S. Guías de Manejo de las Valvulopatias Mitrales. En: Guías de manejo en enfermedades cardiacas y vasculares. Manual Condensado 2010. Velásquez, D. Ed. Editorial Distribuna, 2 edición 2010, 511 paginas. P. 457 – 463. ISBN : 978-958-8379-29-6
54. Franco, S.; Jaramillo, J.S. Guías de Manejo de las Valvulopatias Aorticas. En: Guías de manejo en enfermedades cardiacas y vasculares. Manual Condensado 2010. Velásquez, D. Ed. Editorial Distribuna, 2 edición 2010, 511 paginas. P. 449 – 456. ISBN : 978-958-8379-29-6
55. Franco, S.; Jaramillo, J.S. Guías de Manejo de la Revascularización Coronaria Quirúrgica. En: Guías de manejo en enfermedades cardiacas y vasculares. Manual Condensado 2010. Velásquez, D. Ed. Editorial Distribuna, 2 edición 2010, 511 paginas. P. 437 – 447. ISBN : 978-958-8379-29-6
56. Franco, S.; Bucheli, V. Anatomía Quirúrgica de la Válvula Mitral. En : Enfermedad Valvular Cardiaca. Franco, S. Ed., Editorial Colina, Primera Edición 2010, 440 paginas. P. 26 – 31. ISBN : 978-958-44-7706-4
57. Franco, S.; Bucheli, V. Anatomía Quirúrgica de la Válvula Aortica. En : Enfermedad Valvular Cardiaca. Franco, S. Ed., Editorial Colina, Primera Edición 2010, 440 paginas. P. 33 – 38. ISBN : 978-958-44-7706-4
58. Franco, S. Endocarditis Infecciosa. En : Enfermedad Valvular Cardiaca. Franco, S. Ed., Editorial Colina, Primera Edición 2010, 440 paginas. P. 85 – 113. ISBN : 978-958-44-7706-4
59. Franco, S. Criterios para la Selección de una Prótesis Cardiaca. En : Enfermedad Valvular Cardiaca. Franco, S. Ed., Editorial Colina, Primera Edición 2010, 440 paginas. P. 433 – 440. ISBN : 978-958-44-7706-4
60. Franco, S., Atehortua, M. Endocarditis Infecciosa. En : Estado Actual en Enfermedades Cardiacas y Vasculares 2011. Ed. Editorial Distribuna, 1 Edición 2011, 744 pnas. Pgna 153 – 184. ISBN : 978-958-8379-46-3
61. Franco, S., Atehortua, M. Valvulopatia Mitral. En : Estado Actual en Enfermedades Cardiacas y Vasculares 2011. Ed. Editorial Distribuna, 1 Edición 2011, 744 pnas. Pgna 717 – 727. ISBN : 978-958-8379-46-3
62. Franco, S., Atehortua, M. Cirugía Valvular Aortica. En : Estado Actual en Enfermedades Cardiacas y Vasculares 2011. Ed. Editorial Distribuna, 1 Edición 2011, 744 pnas. Pgna 707 – 717. ISBN : 978-958-8379-46-3
63. Atehortua, M., Franco, S. Revascularización Coronaria Quirúrgica. En : Estado Actual en Enfermedades Cardiacas y Vasculares 2011. Ed. Editorial Distribuna, 1 Edición 2011, 744 pnas. Pgna 675 – 690. ISBN : 978-958-8379-46-3
64. Atehortua, M., Franco, S. Evaluación y Momento Optimo de Intervención en el Paciente con Enfermedad Valvular Cardiaca. En : Estado Actual en Enfermedades Cardiacas y Vasculares 2011. Ed. Editorial Distribuna, 1 Edición 2011, 744 pnas. Pgna 691 – 707. ISBN : 978-958-8379-46-3
65. Atehortua, M., Franco, S. Cirugía en Enfermedad Valvular y Tricuspidea. En : Estado Actual en Enfermedades Cardiacas y Vasculares 2011. Ed. Editorial Distribuna, 1 Edición 2011, 744 pnas. Pgna 727 – 744. ISBN : 978-958-8379-46-3
66. Atehortua, M., Franco, S., Velez, L.A. Guias de Manejo de Revascularizacion Coronaria. En : Guias de Manejo en Enfermedades Cardiacas y Vasculares Estado Actual – 2012. Ed. Editorial Distribuna, 3 Edición 2012, 708 pnas. Pgna 619 – 630. ISBN : 978-958-8379-60-9
67. Velez, L.A., Franco, S., Atehortua, M. Guias de Manejo de las Valvulopatias Aorticas. En : Guias de Manejo en Enfermedades Cardiacas y Vasculares Estado Actual – 2012. Ed. Editorial Distribuna, 3 Edición 2012, 708 pnas. Pgna 631 – 642. ISBN : 978-958-8379-60-9
68. Atehortua, M., Franco, S., Velez, L.A. Guias de Manejo de las Valvulopatias Mitrales. En : Guias de Manejo en Enfermedades Cardiacas y Vasculares Estado Actual – 2012. Ed. Editorial Distribuna, 3 Edición 2012, 708 pnas. Pgna 643 – 653. ISBN : 978-958-8379-60-9
69. Velez, L.A., Atehortua, M., Franco, S. Cirugia en Enfermedad Valvular Pulmonar y Tricuspidea. En : Guias de Manejo en Enfermedades Cardiacas y Vasculares Estado Actual – 2012. Ed. Editorial Distribuna, 3 Edición 2012, 708 pnas. Pgna 655 – 661. ISBN : 978-958-8379-60-9
70. Franco, S., Bucheli, V., Atehortua, M., Velez, L.A. Guias de Manejo en Endocarditis Infecciosa En : Guias de Manejo en Enfermedades Cardiacas y Vasculares Estado Actual – 2012. Ed. Editorial Distribuna, 3 Edición 2012, 708 pnas. Pgna 671 – 690. ISBN : 978-958-8379-60-9
71. Franco, S., Bucheli, V., Atehortua, M., Velez, L.A. Guias de Manejo de los Sindromes Aorticos Agudos. En : Guias de Manejo en Enfermedades Cardiacas y Vasculares Estado Actual – 2012. Ed. Editorial Distribuna, 3 Edición 2012, 708 pnas. Pgna 691 – 702. ISBN : 978-958-8379-60-9
72. Franco, S., Atehortua, M., Velez, L.A. Trauma Cardiaco. En : Guias de Manejo en Enfermedades Cardiacas y Vasculares Estado Actual – 2012. Ed. Editorial Distribuna, 3 Edición 2012, 708 pnas. Pgna 703 – 708. ISBN : 978-958-8379-60-9
Journal articles
1. Franco Sergio, Hincapié Miriam, Mejía Olga. Estudio Epidemiológico de Teníasis. Cisticercosis, San Vicente Antioquia – Colombia, 1985-1986. En: Medicina Tropical y Parasitología Vol. 2 No 1, Ecuador, Diciembre 1985.
2. Franco Sergio, Hincapié Miriam, Mejía Olga. Estudio Epidemiológico de Epilepsia y Neurocisticercosis. En: “Revista Universidad Industrial de Santander – Medicina¨ Vol. 14 No 1, Mayo 1986, p 143- 74.
3. Botero D., Franco S., Hincapié M., Mejía O. Investigaciones Colombianas Sobre Cisticercosis. En: Acta Neurológica. Vol. 2 No 2 Septiembre 1986, p. 3-6.
4. Franco Sergio; Londoño Juan. Dermatopoliomiositis – Reporte de un caso – Revisión del Tema. En: Medicina – U.P.B. Vol. 7 No 2, Noviembre 1988. p. 115.
5. Franco Sergio; Vásquez Jesús; Ortiz Jorge. Infarto Segmentario Idiopático del Epiplón Mayor – Presentación de dos casos y revisión del tema. En: Medicina – U.P.B. Vol. 10 No 2. Octubre. 1991, p. 109.
6. Franco Sergio. Choque Hipovolémico. Medicina U.P.B., Vol. 13 No 2, Octubre, 1994. P. 139-160.
7. Montoya A., Franco S.,. Lung Transplantation for Bronchoalveolar Cell Carcinoma. First Case Report in the Word Literature. 1996 – Loyola University Chicago Annual Report Magazine.
8. Franco S. Autopsy Results in Patients Following Lung Transplantation. Department of Pathology at Loyola University Medical Center. 1996 – Loyola University Chicago Annual Report Magazine.
9. Franco S., Giraldo N., Flórez M. Tratamiento Quirúrgico de la Coartación Aórtica Seguimiento a Largo Plazo – 8 años. Revista Colombiana de Cardiología. Vol. 5 No 5, Diciembre 1996.
10. Franco S, Giraldo N. Trauma Cardíaco: Revisión del Tema. Revista Colombiana de Cardiología. Marzo de 1997.
11. Franco S., Giraldo N., Ramírez C., Vallejo C., Castro H. Revascularización Miocárdica en pacientes con fracción de eyección menor del 30%. Departamento de Cirugía Cardiovascular. Unidad Cardiovascular Clínica Medellín. XVIII Congreso Colombiano de Cardiología. Medellín, 1999. Revista Colombiana de Cardiología, 1999, Vol. 7(6): 301.
12. Franco S., Giraldo N., Fernández H., Ramírez C., Vallejo C., Castro H. Transección Aórtica Traumática: Presentación de tres casos, revisión de la literatura. Departamento de Cirugía Cardiovascular. Unidad Cardiovascular Clínica Medellín. XVIII Congreso Colombiano de Cardiología. Medellín, 1999. Revista Colombiana de Cardiología, 1999, Vol. 7(6): 330.
13. Franco S., Giraldo N., Vélez S. et al. Fístula de la arteria coronaria derecha al tracto de salida del ventrículo derecho. Reporte de un caso – revisión del tema. Departamento de Cirugía Cardiovascular. Unidad Cardiovascular Clínica Medellín. XVIII Congreso Colombiano de Cardiología. Medellín, 1999. Revista Colombiana de Cardiología, 1999, Vol. 7(6): 319.
14. Giraldo N., Franco S., Ramírez C., Vallejo C., Castro H. CIV y Banding de la arteria pulmonar en un paciente adulto. Departamento de Cirugía Cardiovascular. Unidad Cardiovascular Clínica Medellín. XVIII Congreso Colombiano de Cardiología. Medellín, 1999. Revista Colombiana de Cardiología, 1999, Vol. 7(6): 333.
15. Giraldo N., Franco S., Ramírez C., Vallejo C., Castro H. Ruptura Ventricular post implantación de válvula mitral. Departamento de Cirugía Cardiovascular. Unidad Cardiovascular Clínica Medellín. XVIII Congreso Colombiano de Cardiología. Medellín, 1999. Revista Colombiana de Cardiología, 1999, Vol. 7(6): 340.
16. Castro H., Ramírez C., Franco S., Mesa J. et al. Anestesia y técnica quirúrgica en pacientes sometidos a implantación percutánea de endoprótesis en aneurismas de la aorta abdominal. Reporte de tres casos y revisión de la literatura. Departamento de Cirugía y Anestesia Cardiovascular. Departamento de Hemodinámica. Unidad Cardiovascular Clínica Medellín. XVIII Congreso Colombiano de Cardiología. Medellín, 1999. Revista Colombiana de Cardiología, 1999, Vol. 7(6): 331.
17. Vallejo C., Castro H., Ramírez C., Franco S., Duque M. et al. Anestesia y técnica quirúrgica en pacientes sometidos a implante de cardiodesfibrilador automático. Reporte de 20 casos. Departamento de Cirugía y Anestesia Cardiovascular. Departamento de Electrofisiología y Arritmias. Unidad Cardiovascular Clínica Medellín. XVIII Congreso Colombiano de Cardiología. Medellín, 1999. Revista Colombiana de Cardiología, 1999, Vol. 7(6): 336.
18. Ramírez C., Vallejo C., Castro H., Franco S., Giraldo N. et al. Protección Miocárdica: Solución de HTK en Cirugía Cardiaca. Departamento de Cirugía y Anestesia Cardiovascular. Unidad Cardiovascular Clínica Medellín. XVIII Congreso Colombiano de Cardiología. Medellín, 1999. Revista Colombiana de Cardiología, 1999, Vol. 7(6): 336.
19. Ramírez C., Vallejo C., Castro H., Franco S., Giraldo N. et al. Protección Miocárdica: Comparación entre la Solución de HTK y la Solución de Buckberg en Cirugía Cardiaca. Departamento de Cirugía y Anestesia Cardiovascular. Unidad Cardiovascular Clínica Medellín. XVIII Congreso Colombiano de Cardiología. Medellín, 1999. Revista Colombiana de Cardiología, 1999, Vol. 7(6): 336.
20. Vallejo C., Ramírez C., Castro H., Giraldo N., Franco S. Hipotiroidismo y enfermedad cardiaca: Administración de hormona tiroidea vía oral en pacientes sometidos a cirugía cardiaca. Departamento de Cirugía y Anestesia Cardiovascular. Unidad Cardiovascular Clínica Medellín. XVIII Congreso Colombiano de Cardiología. Medellín, 1999. Revista Colombiana de Cardiología, 1999, Vol. 7(6): 334.
21. Franco, S., Giraldo, N., Fernández H., Escobar A., Ramírez, C., Vallejo, C., Castro H. Revascularización miocárdica con arteria radial: Estudio de Casos y Controles. Departamento de Cirugía Cardiotorácica, Clínica Medellín. XIX Congreso Colombiano de Cardiología. Noviembre 27 – Diciembre 1, 2001. Revista Colombiana de Cardiología, 2001, Vol. 9(2): 197.
22. Giraldo, N., Franco, S., Fernández H., Escobar A., Ramírez, C., Vallejo, C., Castro H. Revascularización miocárdica Off Pump: Requerimiento de derivados sanguíneos. Departamento de Cirugía Cardiotorácica, Clínica Medellín. XIX Congreso Colombiano de Cardiología. Noviembre 27 – Diciembre 1, 2001. Revista Colombiana de Cardiología, 2001, Vol. 9(2): 238.
23. Giraldo, N., Franco, S. Fernández H., Escobar A., Ramírez, C., Vallejo, C., Castro H. Endarterectomia Coronaria del tronco principal izquierdo. Departamento de Cirugía Cardiotorácica, Clínica Medellín. CES Medicina Vol. 16 # 1, página 39-44. Enero-Marzo 2002.
24. Franco, S., Giraldo, N., Fernández H., Escobar A., Ramírez, C., Vallejo, C., Castro H. Cierre tardío del esternón en el manejo del sangrado mediastinal post cirugía cardiaca. Departamento de Cirugía Cardiotorácica, Clínica Medellín. CES – Medicina. Vol. 16 # 1, página 27-34. Enero-Marzo 2002.
25. Franco, S., Giraldo, N., Fernández H., Escobar A., Ramírez, C., Vallejo, C., Castro H. Cambio valvular mitral con preservación total del aparato valvular: Técnica quirúrgica, resultados y seguimiento. Departamento de Cirugía Cardiotorácica, Clínica Medellín. CES Medicina. Volumen 16 # 1, página 9-18. Enero-Marzo 2002.
26. Franco S, Giraldo N, Escobar A, Fernández H, Vallejo C, Ramírez C. Cambio valvular mitral con preservación total del aparato valvular: técnica quirúrgica, resultados y seguimiento. Revista Colombiana De Cardiología. 2003. pp. 368 – 74
27. Giraldo N, Franco S, Escobar A, Fernández H, Vallejo C, Ramírez C. Cierre tardío del esternón en el manejo del sangrado mediastinal post cirugía cardiaca. Revista Colombiana De Cardiología 2003. pp. 95 – 99
28. Escobar A., Giraldo N., Franco S., Jaramillo J., Orozco A. Taquiarritmias supraventriculares postcirugia cardiaca con y sin el uso de circulación extracorpórea. En : CES Medicina Volumen 17 # 1, Enero-julio 2003, Pgnas 23-31
29. Echeverri JL, Gonzáles M, Franco S., Vélez LA. Ruptura traumática de la aorta. Reporte de dos casos y revisión de la literatura. Medicina Crítica y Cuidados Intensivos. Enero – Junio 2004, 2 (1) : 31-35
30. Franco, S. Giraldo, N., Gaviria, A. et al. Aneurismas y seudoaneurismas de injertos venosos coronarios. Revista Colombiana de cardiología, Vol. 11 # 8, Abril 2005. Pgna 401- 404.
31. Franco, S.; Uribe, W.; Velez, JF. et al. Tratamiento quirurgico curativo de la fibrilacion atrial mediante tecnica de ablacion con radiofrecuencia monopolar irrigada : resultados a corto y mediano plazo. Revista Colombiana de Cardiologia. 2007. Vol 14, # 1. Pnas 43 – 55.
32. Escobar, A., Franco,S., Giraldo,N., et al. Tecnica de perfusion selectiva cerebral via subclavia para la correccion de patologias del arco aortico. Revista Colombiana de Cardiologia Volumen 14, numero 4, agosto 2007. P 232-237
33. Franco, S.Tratamiento quirurgico de la fibrilacion atrial. Revista Colombiana de Cardiologia – Guias de Diagnostico y Tratamiento de la Fibrilacion Auricular. Vol 14, Suplemento 3, Octubre 2007. P. 133 – 143.
34. Franco, S. Velez, A., Uribe, W., Duque, M., Velez, JF, et al. Tratamiento quirurgico de la fibrilacion atrial mediante radiofrecuencia. Revista Medica Sanitas 2008, Volumen 11, Numero 1, pgnas 8 – 20. Febrero – Abril, 2008.
35. Franco,S., Herrera, AM., Atehortua, M. et al. Use of Steel bands in sternotomy closure : implications in high-risk cardiac surgical population. Interactive CardioVascular and Thoracic Surgery 8 (2009) : 200-205.
36. Franco, S.Tratamiento Quirurgico para el manejo de las arritmias ventriculares. Guias Colombianas de Cardiologia. Artitmias Ventriculares y Muerte Subita. Revista Colombiana de Cardiologia. Volumen 18, Suplemento 1. Pgnas 160 – 163. Febrero 2011.
37. Miranda, A. ; Franco, S.,; Uribe, W. et al. Tromboembolismo Pulmonar Masivo de Alto Riesgo. Medicina ( Buenos Aires), 72 : 2012; Pgnas 128-130.
38. Miranda, A., Duque, M., Franco, S., Velasquez, J. et al. Tromboembolismo Pulmonar Masivo. Indicaciones de Cirugia – Reporte de caso. Revista Colombiana de Cardiologia. Volumen 19, Suplemento 1. Marzo de 2012.
39. Franco, S.; Eusse, A.; Atehortua, M., Vélez, L., et al. Endocarditis Infecciosa : Análisis de Resultados del Manejo Quirúrgico Temprano. Revista Colombiana de Cardiologia. Volumen 19, Suplemento 1, pgna 66. Marzo de 2012.
40. Franco, S.; Bucheli, V.; Atehortua, M., Vélez, L.; Eusse, A et al. Tratamiento Quirurgico : El “Gold Estándar” en el manejo de los defectos del septum interauricular. Revista Colombiana de Cardiologia. Volumen 19, Suplemento 1. Marzo de 2012.
41. Franco, S.; Atehortua, M., Vélez, L.; Castro, H., et al. Anomalías coronarias del Adulto. Origen anómalo de la arteria coronaria izquierda de la arteria pulmonar (ALCAPA). Reporte de caso. Revista Colombiana de Cardiologia. Volumen 19, Suplemento 1, pgna 61. Marzo de 2012.
42. Franco, S.; Atehortua, M., Vélez, L.; Castro, H., et al. Metástasis cardiaca de carcinoma anaplasico de tiroides. Reporte de caso. Revista Colombiana de Cardiologia. Volumen 19, Suplemento 1, pgna 70. Marzo de 2012.
43. Franco, S.; Giraldo, N.; Atehortua, M., Vélez, L.; Castro, H., et al. Endarterectomia coronaria del tronco principal izquierdo : Seguimiento a 15 años. Reporte de caso. Revista Colombiana de Cardiologia. Volumen 19, Suplemento 1, pgna 66. Marzo de 2012.
44. Franco, S.; Atehortua, M., Vélez, L.; Castro, H., Bucheli, V.; et al. Implante de válvulas biológicas : evaluación de libertad de reoperación por deterioro valvular estructural. Revista Colombiana de Cardiologia. Volumen 19, Suplemento 1, pgna 69. Marzo de 2012.
45. Miranda, A. Franco, S. Uribe, W., Duque, M. et al. Tromboembolismo Pulmonar Masivo de Alto Riesgo Asociado a Foramen Ovale Permeable. Medicina (Buenos Aires) 72 : 128 – 130. 2012.
46. Franco, S.Criterios Para la Selección de Una Protesis Cardiaca. Rev Fed Arg Cardiol. 2012; 41(3): 156 – 160.
Special topics in Cardiac Surgery: (Monographs)
1. Franco Sergio. Manejo Básico Inicial del Paciente Con Trauma CortoPunzante En: Monografía. Hospital San Vicente de Paúl – Prado (Tolima) 1989.
2. Franco S; Montoya A. Transplante Pulmonar: Indicaciones, Criterios de Selección y rechazo, Técnica Quirúrgica, Manejo de Donante y receptor, Complicaciones. Protocolo para la realización de transplante pulmonar en nuestro medio. Comité de transplantes de corazón y pulmón. 1996. Clínica Cardiovascular Santa María, Biblioteca Médica – Facultad de Medicina, Universidad Pontificia Bolivariana
3. Giraldo N., Franco S., Estudiantes X Semestre Instituto de Ciencias de la Salud – CES. Tratamiento Quirúrgico de la Endocarditis Infecciosa. Monografía. Investigación realizada en la Clínica Cardiovascular Santa Maria. Publicación Monográfica. Enero 1997.
4. Franco S. Safenectomía Videoendoscópica. Realización de video con descripción de la técnica quirúrgica. Descripción Monográfica. Departamento de Cirugía Cardiovascular. Unidad Cardiovascular Clínica Medellín. Diciembre de 1997.
5. Franco S., Giraldo N., Fernández H. Tratamiento Quirúrgico de la Enfermedad Pulmonar Obstructiva Crónica. Cirugía de Reducción de Volumen Pulmonar. Monografía, Departamento de Cirugía Cardiovascular – Unidad Cardiovascular Clínica Medellín. Octubre 1999.
6. Franco S., Escobar A. Trauma de Tórax. Revisión del tema. Monografía. Departamento de Cirugía Cardiovascular / Unidad Cardiovascular Clínica Medellín. Octubre de 1999.
7. Franco S., Jaramillo J.C. Cirugía en el paciente con Angina. Consenso Nacional sobre el Manejo de la Angina de Pecho. Sociedad Colombiana de Cardiología. Bogota, 11-12 agosto 2000.
8. Franco, S. Fibrilación Atrial: Tratamiento Quirúrgico. I Actualización del Consenso Nacional Sobre Fibrilación Atrial. Capitulo de Electrofisiología, Sociedad Colombiana De Cardiología. Abril 2002.
9. Franco, S, Jaramillo JS, Vélez JF, Castro H. Infecciones Mediastinales. Monografía. Departamento de Cirugía Cardiovascular. Hospital Departamental Santa Sofía de Caldas, Manizales. Mayo de 2003.
10. Guias Colombianas de Cardiologia. Fibrilacion Atrial – Guias de bolsillo.
Duque, M, Marin, J, ed. Franco, S. Cirugia de fibrilacion atrial. Sociedad Colombiana de Cardiologia y Cirugia Cardiovascular. 2008.
11. Franco, S. Long-Term Effectiveness of HIFU on Atrial Fibrillation in High Risk Valvular Surgery Patients. A Clinical Interview from Epicor- Cardiac Ablation System – St Jude Medical. March 2009.
I apologize for the wordiness of this post – but much of what we discuss below is covered in the Bogotá, Cartagena and Mexicali books – the essential mechanisms of cardiac surgery; how procedures work, what is off-pump surgery, when do we use the bypass pump and other explanatory information. But since I have am not writing a full book on Medellin, I wanted to offer a bit of a primer for my new internet readers here.
Dr. Luis Meza
Cardiac surgeon, Hospital General de Medellin
After interviewing Dr. Meza and meeting many of the staff at Hospital General de Medellin, it was a pleasure to be invited to observe Dr. Meza and Dr. Urequi , the head of the cardiac surgery department in the operating room. Despite the patient’s young age, the surgery (for me as an observer) was knuckle-biting. While the surgery itself was a fast, straight-forward and uncomplicated repair of an interauricular septal defect – it was the patient’s fragile condition that had me on the edge of my seat.
Complex patients The case was typical of many of the cases they see at public hospitals. It was a young patient with newly diagnosed right-sided heart failure due to an uncorrected congenital defect. The patient had traveled from another part of Colombia (one of the poorer regions) to have surgery. The patient had initially presented to a local doctor after a syncopal event (passing out) and was found to have an enlarged heart, with a moderate sized pericardial effusion (fluid in the sac around the heart.) After arriving at HGM, the patient was also diagnosed with a serious acquired coagulopathy (bleeding disorder).
drawing courtesy of Wikipedia (Creative Commons licensing)
Since the patient had a hole between the left atrium leading into the right atrium, blood was being pushed from the left atrium (which is under higher pressure) to the low pressure right atrium. Over the course of many years, this had caused the right atrium to enlarge massively. As the right atrium was continuously being overfilled (from blood from the left side), the right side of the heart was being forced to work harder, and harder. As the atrium continued to be overstretched, and enlarged – it also caused blood to be forced back into the pulmonary arteries – causing pulmonary hypertension. While pre-surgical tests (echocardiogram, and cardiac catheterization) showed the patient to have (only) moderate pulmonary hypertension (with PA systolic pressures of 65mmHg).
Pre-operative testing is only part of the story
However, when we looked down, into the patient’s chest – it was obvious that the patient’s pulmonary vasculature was engorged and enlarged. The patient’s heart was massive, and floppy (which is a sign the heart is working way too hard). The patient also had peripheral edema which is another sign that the heart was not working well.
Potential for badness*
So even though, the surgery itself (described below) is not terribly technically challenging (‘like darning socks’ one surgeon used to say) – a lot can go wrong because the patient’s heart just doesn’t work that well to begin with.
* a not-so-scientific term to describe the likelihood of potential complications, problems or adverse outcomes. These may be unavoidable circumstances in many cases – but the term is a reminder to remain vigilant even during so-called “simple” procedures.
Nitric oxide on hand
This OR does have nitric oxide – (which we didn’t need), but was available nearby, just in case. Nitric oxide, milrinone and other medications are critical to have on hand in patients with pulmonary hypertension. Some patients will never need it – others can’t survive without it – and sadly, (in patients with severe fixed pulmonary hypertension), nothing – not even an assist device is going to make much difference. While we can try to predict which patients are going to tolerate surgery, it’s not always clear-cut. Tests (echocardiograms, right heart caths) can predict, tests can give probabilities – but sometimes tests are wrong, and patients who appear to have only ‘mild’ disease do very poorly (and visa versa). Sometimes, we just have to hold our breath as the patient comes off bypass and see.
canisters of nitric oxide in OR #1
As I mentioned in a previous post – cardiac surgery procedures can be a bit more complicated than many other surgical procedures, and while having something like nitric oxide on hand doesn’t seem like a big deal – it is. (I have worked in several facilities without these capabilities). It also speaks to the general preparedness of the staff. But despite the ‘potential for badness’ everything proceeded beautifully with Drs. Urequi and Meza. The case seemed to speed by despite the patient’s fragile health. The entire CPB (cardiopulmonary bypass run) was just 26 minutes with a total cross-clamp time of 31 minutes.)
A little bit about cardiopulmonary bypass – the “heart-lung machine”
In comparison to the congenital repair above, average CPB times for valve replacement run around 100 minutes, 60 to 90 minutes for bypass surgery. Patients have a higher risk of CPB related complications from hypo/ altered perfusion after long pump runs . As the clock begins to exceed 120 minutes, the risk of renal failure, cognitive changes and bleeding problems (as blood cells are continuous smashed/ broken / damaged within the pump) increase.
What is “Off-pump surgery”? Nowadays, lots of people get real excited about “off-pump” surgery because they think that by not using the heart-lung machine, they can avoid a lot of the problems we mentioned above. But that’s oversimplifying the entire scenario – and one that I find is often used to “sell” a particular surgeon or surgical program. Off-pump can be safer than CPB cases, for some patients. But these are usually not the patients that the surgery is sold to.. So it’s important to know what some of the terminology really means. Just because Hospital X has billboards announcing that they now perform off pump surgery – doesn’t mean that it’s something you may even need or want.
Off pump is not for everyone
Patients have to be fairly healthy to tolerate cardiac surgery without the pump. People with a lot of the problems that we thought were worsened by the pump, actually fare worse when we try to do surgery without the heart-lung machine. For example, we initially thought that Off-pump surgery would be great for people with renal insufficiency or ‘bad kidneys’ – particularly people who have kidney problems but aren’t quite sick enough to be on dialysis yet. The hope was that by avoiding the bypass pump we could avoid any damage to the kidneys from artificial flow/hypoperfusion because one of the biggest risks of cardiac surgery in patients with bad kidneys is that surgery will cause their kidneys to fail entirely, and make patients dialysis dependent. Unfortunately, the research from all of the off-pump surgeries being done hasn’t really shown the benefits that we thought it would. So like most things in medicine, it’s not quite the panacea we had hoped it was. But we did learn an incredible amount of information once surgeons started trying off pump surgeries for coronary bypass. Surprisingly, we learned that many of the complications, and conditions that we had long blamed on the CPB pump – weren’t related to the machine at all. But much of this is still being argued by cardiac surgeons every single day – each with different research studies giving different results..
More importantly, Off-pump not possible for many types of cardiac surgery
It’s technically impossible to do some types of cases without the bypass pump. Coronary bypass surgery (CABG) is very different from other types of surgery, for example. During bypass, the surgeon is only operating on the outside of the heart – attaching new conduit (arteries and veins) to arteries on the surface of the heart. So – it isn’t absolutely essential to have the pump circulating blood for him while he’s operating – in some patients – we can let their body do it for us during surgery.
But replacing diseased heart valves, or the great vessels (aortic aneurysms etc) is a completely different entity. In those surgeries – the surgeon is cutting into the heart or great vessels themselves. It’s not possible to lop off the top of the aorta, operate on the aortic valve and not have blood being re-directed mechanically during this process. Otherwise blood would just literally spill out into the chest and never oxygenate the brain and the rest of the body. (The only time we ever do this kind of procedure without a pump is during organ retrieval – for obvious reasons). It’s important to know these distinctions so people understand how the surgery actually proceeds.
For the case today – the surgeon has to make an incision through the side of the atria (wall of the heart chamber) to get to the hole on the inside wall of the heart.) The surgeon then closes the hole with suture (and a patch, in some cases). Some doctors do this in the cath lab without surgery – but that’s also controversal because the patch used in the cath procedures in the past has caused a high incidence of stroke. In a young patient like the one here – you certainly wouldn’t want to risk it – particularly since we don’t know how well those patches hold up in the long term.
Cardiac surgeons operate at Hospital General de Medellin (HGM)
Overall evaluation of today’s case:
Safety checklists, and all pre-operative procedures were completed. Patient was prepped and draped in an appropriate sterile fashion. Antibiotics were administered within the recommended window (of time). Appropriate records were maintained during the case.
Surgery proceeded normally and without incident.
Due to an underlying coagulopathy the patient did require administration of nonautologous blood products (4 units of packed red blood cells, 3 packets of platelets, and abumin) while on pump. While the facility does not have a ‘cell-saver’ for washing and re-infusing shed blood, patient did receive autologous(their own) transfusion from the CPB pump. This blood, from the CPB circuit was returned to the patient to limit the amount of blood needed after surgery. Hemoglobin at the conclusion of surgery was 9.6mg/dl, which is within acceptable parameters.
Hemostasis was obtained prior to chest closure, with only a small amount of chest tube drainage in the collection chamber at the time of transfer to the intensive care unit.
Surgical Apgars – do not apply for cardiac cases due to the nature of the case, and use of CPB. Mean pressure while on CPB was within an acceptable range. Patient’s urinary output was less than anticipated during the case (150cc) despite the use of mannitol while on pump, but the patient responded well (1000+) with volume infusion and the addition of furosemide.
The patient was hemodynamically stable during the entire case. The was a very brief transitory period of hypotension (less than 5 minutes) near the conclusion of the case, which was immediately noted by anesthesia and treated with no recurrence.
On transfer to the unit, the patient was accompanied by several members of the OR staff, including Dr. Meza, the anesthesiologist, and the perfusionist, each of which did a face-to-face “hand-off” report of the patient (and medical history) including the course of the surgical procedure (including medications given, lab values, procedural details) to the Intensivist (physician), with ICU nursing staff attending to the patient.
Transesophageal echo (TEE) was not performed during this case, but was available if needed.
Also, I am happy to report there were no smartphones or “facebooking” in sight. No one appeared engaged in anything other than the surgery at hand.
If you’ve never been to the cardiac operating room – it’s a completely different world, and not what most people expect. For starters, unlike many areas of health care (particularly in the USA), the cardiac operating room is usually very well staffed.
Just a few of the people working in the OR. (photo edited to preserve patient privacy)
For example, there were eight people working in the operating room today:
Dr. Suarez observes her patient during surgery. (photo edited to preserve patient’s privacy)
Ms. Catherine Cardona, “Jefe”/ Nurse who supervises the operating room
Ms. Diana Isobel Lopez, Perfusionist (In Colombia, all perfusionists have an undergraduate degree in nursing, before obtaining a postgraduate degree in Perfusion). The perfusionist is the person who ‘runs’ the cardiac bypass machine.
Ms. Laura Garcia, Instrumentadora (First Assist)
Angel, circulating nurse
Olga, another instrumentadora, who is training to work in the cardiac OR.
This is fairly typical for most institutions.
Secondly – it’s always a regimented, and checklist kind of place. (I wish I could say that about every operating room – but it just wouldn’t be true.) But cardiac ORs (without exception) always follow a very strict set of accounting procedures..
For starters – there are labels.. For the patient (arm bands), for the equipment (medications, blood products etc..) even the room is labeled.
Sign on operating room door (edited for patient privacy)
Then come the checklists..
Perfusionist Diana Lopez gathers information to begin her pre-operative checklist.
The general (WHO) operating room checklist. The perfusionist’s checklist.. The anesthesiologist’s checklist.. and the big white cardiac checklist.
by the end of the case, this board will be full..
The staff attempts to anticipate every possible need and have it on hand ahead of time. Whether it’s nitric oxide, blood, defibrillation equipment, or special medications – it’s already stocked and ready before the patient is ever wheeled in.
Most of these things are universal:
such as the principles of asepsis (preventing infection), patient safety and preventing intra-operative errors – no matter what hospital or country you are visiting (and when it comes to surgery – that’s the way it should be.)
Today was no exception..
In health care, we talk about “OR people” and “ER people”.. ER people are the MacGyvers of the world – people who thrive on adrenaline, excitement and the unexpected. They are at their best when a tractor-trailer skids into a gas station, ignites and sets of a five-alarm fire that decimates a kindergarden, sending screaming children racing into the streets.. And God love them for having that talent..
But the OR.. that’s my personal area of tranquility.
This orderly, prepared environments is one of the reasons I love what I do.. (I am not a screaming, “by the seat-of-your-pants”/ ‘skin of your teeth’ kind of gal). I don’t want to encounter surprises when it comes to my patient’s health – and I never ever want to be caught unprepared. That’s not to say that I can’t handle an emergent cardiac patient crashing in the cath lab – it just means I’ve considered the scenarios before, (and have a couple of tricks up my sleeve) to make sure my patient is well taken care of (and expedite the process).
That logical, critical-thinking component of my personality is one of the reasons I am able to provide valuable and objective information when visiting hospitals and surgeons like Dr. Urequi’s and Dr. Meza’s operating room at Hospital General de Medellin.
In OR #1 – cardiothoracic suite
As I mentioned in a previous post on Hospital General de Medellin, operating room suite #1 has been designated for cardiac and thoracic surgeries. This works out well since the operating room itself, is modern and spacious (which is important because of the area needed when adding specialized cardiac surgery equipment like the CPB pump (aka heart-lung machine). There are muliple monitors, which is important for the video-assisted thoracoscopy (VATS) thoracic cases but also helpful for the cardiac cases. The surgeon is able to project the case as he’s performing it on a spare monitor, which allows everyone involved to see what’s going on during the case (and anticipate what he will need next) without shouting or crowding the operating room table.
Coordinating care by watching surgery
For instance, if the circulator looks up at the monitor and sees he is finishing (the bypasses for example), she can make sure both the instrumentadora and the anesthesiologist have the paddles and cables ready to gently defibrillate the heart if it needs a little ‘jump start’ back into normal rhythm..or collect lab samples, or double check medications, blood products or whatever else is needed at specific points during the surgery.
Dr. Luis Fernando Meza Valencia, cardiac surgeon and his wife, Dra. Elaine Suarez Gomez, anesthesiologist have a terrific partnership as part of the Cardiac Surgery program at Hospital General de Medellin (HGM). (Hospital General de Medellin is one of just a few public hospitals that have heart surgery programs.)
Dr. Meza, a Cali native who trained at Fundacion Cardioinfantil under the instruction of Dr. Pablo Umana, Dr. Nestor Sandoval along with Dr. Maldonado now performs coronary bypass, valve replacement, surgery on the great vessels (such as ascending arch replacement, aortic aneurysm repair) at the Hospital General de Medellin as well as several smaller, private facilities like Clinica Las Vegas.
He has worked at HGM for 2 1/2 years since he moved from the public hospital in Manizales (in the coffee-growing region of central Colombia).
Dra. Elaine Suarez is a anesthesiologist who has specializes in cardiothoracic anesthesia. She has been practicing for five years and is fluent in English and German in addition to her native Spanish.
High risk patients
Because HGM serves the public and many of their patients are impoverished, Dr. Meza and Dra. Suarez see a large number of rheumatic heart disease and endocarditis patients. Many of these patients have had very limited preventative care or medical management of their underlying chronic health conditions. A large number of these patients have significant co-morbid conditions such as diabetes, chroic pulmonary disease, hypertension, hyperlipidemia, and nephropathies (kidney damage). This subset of patients almost always presents in the midst of a cardiac emergency.
In the Consulta Externa
Dr. Meza reports that he usually spends at least an hour with his patients during the initial consultation, gathering information, examining the patient and explaining the necessary tests and treatments.
In the Operating Room
Haven’t had an opportunity to follow Dr. Meza to the operating room yet, but we did get to see Dra. Suarez in action.
Long time readers (and former patients) will be familiar with my aspirin mantra but now Medscape has published a CME course by Dr. Desiree Lie for health care providers in primary practice, general surgery (and other areas that may not be familiar with post-cardiac patient recommendations.) As I may have mentioned before, in cardiac surgery – we routinely start aspirin in our patients prior to bypass surgery.
Know the most current recommendations for aspirin and surgery
Don’t stop Aspirin before surgery
I’ve converted the CME course, Don’t stop Aspirin before surgery into a pdf – but if you want credit – you will have to go to Medscape and log in. (For everyone else – it’s a nice read – and explains the importance of continuing aspirin in patients who are taking it for “secondary prevention” or are at high risk of cardiovascular events.
That’s because the complications of discontinuing aspirin therapy in these patients are WORSE than the minor risk of bleeding. (Bleeding issues for most patients taking aspirin are fairly minor.. Now, clopidogrel (Plavix) and prasugrel (Effient) are another story!)
Wait a second… What’s secondary prevention?
They way to think about secondary prevention is “closing the barn after the cows are loose,” as one of my colleagues explains it. This means that Aspirin has been prescribed to these patients after something has already happened – like a stroke, a heart attack, stents or cardiac surgery. So in these patients – secondary prevention can be thought of as preventing a second event or further complications from a disease process we already know about.
Now, patients that are at high risk for cardiovascular events like diabetics or people with other kinds of blockages (peripheral vascular disease, renal artery stenosis) haven’t had a heart attack yet – but we think that they are at a high risk of this happening – so they take aspirin to prevent this (primary prevention).
In people who are at low or moderate risk – low cholesterol, nonobese, normal glucose, nonsmokers: these people may take aspirin, but (probably not prescribed) and it is safe for them to discontinue aspirin before surgery.
But in the first two classes of patients (secondary prevention group/ high risk group) – stopping aspirin may actually INCREASE the risk of having a heart attack, stroke or other thrombotic event during surgery. But if you are having surgery – be sure to check with your cardiologist or cardiac surgeon before. Don’t rely on your PCP or general surgeon (it’s not their area of expertise) and they may not be up-to-date on the latest recommendations [hence the continuing education course].
As always – these posts are not medical advice – but should serve as talking points for patients when soliciting medical advice from their healthcare providers.
It looks like the rest of the medical community is finally speaking up about the overuse and safety issues of TAVI/ TAVR for aortic stenosis, but it’s still few and far between – and in specialty journals… But in the same week that Medscape, and the Heart.org reported on a newly published article in the British Medical Journal on the overuse of TAVI therapies, and the need for earlier diagnosis and treatment of Aortic Stenosis – the Interventionalists over at the Heart.org (a cardiology specialty journal) have published a series of articles promoting / pushing the procedure including an article entitled, “The TAVR Heart team roles.”
JAMA recently published a paper by Robert Bonow and Chintan Desnai, discussing the benefits, risks and expectations with TAVI. This paper discusses the very real need for clinicians to address heightened patient expectations regarding TAVI as an ‘easy’ alternative to surgery.
Here at Cartagena Surgery – we’ve been doing our own research – contacting and talking to a multitude of practicing cardiologists and cardiac surgeons to get their opinions – in addition to reviewing the latest data.
In related news, a review of the latest research on the ‘transcatheter’ valve therapies demonstrates considerable concern: including data on peri-valvular leaks as reported in the last national TAVI registries in Europe and in the US:
• The incidence of paravalvular leaks after TAVI is extremely high ( > 60%)
• It is technically challenging today to quantify these leaks.
• Most of them are quoted “mild”, but more than 15 % are estimated “moderate” and “severe”.
• In > 5% of patients, the peri-valvular or valvular regurgitation grade increased significantly over time.
• there is no significant difference between Edwards SAPIEN and Medtronic COREVALVE
As one cardiologist explained:
“Importantly, the thrombogenic potential of mild leaks was recently demonstrated by Larry Scotten ( Vivitro System Inc. Victoria, Canada). High reverse flow velocities expose glycoprotein GP Ib-IX-V platelet receptors to circulating Von Willebrand molecule with, as results, platelet aggregation and fibrin formation. The incidence of brain spots and stroke after TAVI was of great concern in the PARTNER A and B studies. Whereas, Aspirin is not mandatory in patients implanted with bioprosthetic valves, Plavix + Aspirin is recommended for all TAVI patients. The rationales of such therapy were not explained so far.”
Valve oversizing – a surgeon explains
“To reduce these peri-valvular leaks , cardiologists tentatively use large valve size, up to 29-mm. The very large majority of valve sizes used in conventional aortic valve replacement are smaller than 25-mm. Oversizing may increase the risk of late aortic aneurysms (aortic rupture has been reported) [emphasis added].
Moreover, atrio-ventricular conduction may be impaired with the need of permanent pacing. Poorer outcomes have been reported in patients when the need for permanent pacemaker occurs.
“As we like to say about clothes and shoes, you forget the price overnight but you remember the quality for ever . The price of TAVI may be cheaper but patients may experience inferior outcomes. In view of these results, using TAVI would not be appropriate for the great majority of heart valve candidates. Moreover trans-catheter delivery and sub-optimal fit are not likely to increase tissue valve durability… and everybody knows that tissue valves are not enough durable for young adults and children. TAVI is thus a suitable strategy only for the neglected population of high risk patients who are no longer candidates for surgery [emphasis added].
Worth pointing out again that there would be no need for TAVI and long-term outcomes of patients would be much better if severe aortic stenosis were correctly managed at the right time. Enclosed the recommendations of Robert Bonow (Circulation, July 25, 2012) for early valve replacement in ASYMPTOMATIC patients. A large cohort of accurate biomarkers is available today for correct timing of surgery and consequent prevention of irreversible myocardium damage. In the study of Lancellotti (enclosed) 55% of “truly asymptomatic patients” with severe aortic stenosis developed pulmonary hypertension during exercise and had poor clinical outcomes. The measurement of both mean trans-aortic pressure gradient and systolic pulmonary pressure, which are technically easy, rapid and with good reproducibility may improve the management of such patients.
These updates on the natural history of aortic stenosis illustrate the present paradoxical and intriguing focus of the industry on an experimental procedural innovation for end-stage old patients when more efficient heart valves are today feasible and could be used sooner for the benefit of all patients .
Modified from Ross J and Branwald E (Circulation 1968 (Suppl): 61-67)
• The incidence of stroke was 9% after TAVI in the 214 patients of the enclosed study published last week in the American Journal of Cardiology. The incidence of stroke with TAVI was > two times higher than with conventional surgery in the PARTNER study. Pooled proportion of postoperative stroke was 2.4% with conventional surgery in the large meta-analysis of patients > 80 years old (enclosed)
• Peri-valvular aortic insufficiency is observed in more than 60% of patients undergoing trans-catheter aortic valve replacement. Moderate or severe aortic insufficiency was seen in 17.3 % of the PARTNER inoperable and high risk cohorts at 1 year. They have been reportedly associated with dyspnea, anemia, cardiac failure and diminished survival. Most interestingly, the FDA does not accept more than 1% peri-valvular insufficiency in patients implanted with conventional prosthetic heart valves… The SJM Silzone mechanical heart valve was re-called because of peri-valvular leakage rate of… 1.5 % .
• Traditionally, aortic stenosis involving a 2-cuspid aortic valve has been a contraindication to TAVI. Of 347 octogenarians and 17 nonagenarians explanted valves , 78 (22%) and 3 ( 18%) had stenotic congenitally bicuspid aortic valve, respectively. Because the results of TAVI are less favorable in patients with stenotic congenitally bicuspid valves, proper identification of the underlying aortic valve structure is critical when considering TAVI in older patients . More than 50% of patients with aortic stenosis have bicuspid aortic valve and are not, therefore, good candidates for TAVI. Most importantly, the great majority of patients with calcified stenotic bicuspid aortic valves is young ( < 60 years old) and not candidate for tissue valve replacement.
• The French Registry of trans-catheter aortic-valve implantation in high-risk patients was published in the New England Journal of Medicine on May 3, 2012. It reports 3195 TAVI procedures during the last two years at 34 centers.
The mean age was 83 years. The incidence of stroke was 4.1%. Peri-prosthetic aortic regurgitation was 64 %. The rate of death was 24% at one year. At the same time, the meta-analysis published in the American Heart Journal reports 13,216 CONVENTIONAL AORTIC VALVE REPLACEMENT in patients > 80 years old. The rate of death was 12.4% at one year, 21.3% at 3 years and 34.6% at 5 years
Full references for works cited in text:
Bonow, R. O. (2012). Exercise hemodynamics and risk assessment in asymptomatic aortic stenosis. Circulation 2012, July 25.
Lancelloti, P., Magne, J., Donal, E., O’Connor, K., Dulgheru, R., Rosca, M., & Pierard, L. (2012). Determinants and prognostic significance of exercise pulmonary hypertension in asymptomatic severe aortic stenosis. Circulation, 2012 July 25.
Takkenberg, J. J. M., Rayamannan, N. M., Rosenhek, R., Kumar, A. S., Carapitis, J. R., & Yacoub, M. H. (2008). The need for a global perspective on heart valve disease epidemiology: The SHVG working group on epidemiology of heart disease founding statement. J. Heart Valve Dis. 17 (1); 135 – 139.
Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, Fajadet J, Leprince P, Leguerrier A, Lievre M, Prat A,Teiger E, Lefevre T, Himbert D, Tchetche D, Carrié D, Albat B, Cribier A, Rioufol G, Sudre A, Blanchard D, Collet F, Dos Santos P, Meneveau N, Tirouvanziam A, Caussin C, Guyon P, Boschat J, Le Breton H, Collart F, Houel R, Delpine S,Souteyrand G, Favereau X, Ohlmann P, Doisy V, Grollier G, Gommeaux A, Claudel JP, Bourlon F, Bertrand B, Van Belle E, Laskar M; FRANCE 2 Investigators. Collaborators (184). Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med. 2012 May 3; 366(18):1705-15 [full abstract below].
BACKGROUND:
Transcatheter aortic-valve implantation (TAVI) is an emerging intervention for the treatment of high-risk patients with severe aortic stenosis and coexisting illnesses.
We report the results of a prospective multicenter study of the French national transcatheter aortic-valve implantation registry, FRANCE 2.
METHODS:
All TAVIs performed in France, as listed in the FRANCE 2 registry, were prospectively included in the study. The primary end point was death from any cause.
RESULTS:
A total of 3195 patients were enrolled between January 2010 and October 2011 at 34 centers. The mean (±SD) age was 82.7±7.2 years; 49% of the patients were women.
All patients were highly symptomatic and were at high surgical risk for aortic-valve replacement. Edwards SAPIEN and Medtronic CoreValve devices were implanted in 66.9% and 33.1% of patients, respectively. Approaches were either transarterial (transfemoral, 74.6%; subclavian, 5.8%; and other, 1.8%) or transapical (17.8%).
The procedural success rate was 96.9%. Rates of death at 30 days and 1 year were 9.7% and 24.0%, respectively.
At 1 year, the incidence of stroke was 4.1%, and the incidence of periprosthetic aortic regurgitation was 64.5%.
In a multivariate model, a higher logistic risk score on the European System for Cardiac Operative Risk Evaluation (EuroSCORE), New York Heart Association functional class III or IV symptoms, the use of a transapical TAVI approach, and a higher amount of periprosthetic regurgitation were significantly associated with reduced survival.
CONCLUSIONS:
This prospective registry study reflected real-life TAVI experience in high-risk elderly patients with aortic stenosis, in whom TAVI appeared to be a reasonable option.
Rutger-Jan Nuis, MSc, Nicolas M. Van Mieghem, MD, Carl J. Schultz, MD, PhD, Adriaan Moelker, MD, PhD , Robert M. van der Boon, MSc, Robert Jan van Geuns, MD, PhD, Aad van der Lugt, MD, PhD, Patrick W. Serruys, MD, PhD, Josep Rodés-Cabau, MD, Ron T. van Domburg, PhD, Peter J. Koudstaal, MD, PhD, Peter P. de Jaegere, MD, PhD. Frequency and Causes of Stroke During or After Trans-catheter Aortic Valve Implantation.American Journal of Cardiology Volume 109, Issue 11 , Pages 1637-1643, 1 June 2012 [full abstract provided].
Transcatheter aortic valve implantation (TAVI) is invariably associated with the risk of clinically manifest transient or irreversible neurologic impairment. We sought to investigate the incidence and causes of clinically manifest stroke during TAVI. A total of 214 consecutive patients underwent TAVI with the Medtronic-CoreValve System from November 2005 to September 2011 at our institution. Stroke was defined according to the Valve Academic Research Consortium recommendations. Its cause was established by analyzing the point of onset of symptoms, correlating the symptoms with the computed tomography-detected defects in the brain, and analyzing the presence of potential coexisting causes of stroke, in addition to a multivariate analysis to determine the independent predictors. Stroke occurred in 19 patients (9%) and was major in 10 (5%), minor in 3 (1%), and transient (transient ischemic attack) in 6 (3%). The onset of symptoms was early (≤24 hours) in 8 patients (42%) and delayed (>24 hours) in 11 (58%). Brain computed tomography showed a cortical infarct in 8 patients (42%), a lacunar infarct in 5 (26%), hemorrhage in 1 (5%), and no abnormalities in 5 (26%). Independent determinants of stroke were new-onset atrial fibrillation after TAVI (odds ratio 4.4, 95% confidence interval 1.2 to 15.6), and baseline aortic regurgitation grade III or greater (odds ratio 3.2, 95% confidence interval 1.1 to 9.3).
In conclusion, the incidence of stroke was 9%, of which >1/2 occurred >24 hours after the procedure. New-onset atrial fibrillation was associated with a 4.4-fold increased risk of stroke. In conclusion, these findings indicate that improvements in postoperative care after TAVI are equally, if not more, important for the reduction of peri-procedural stroke than preventive measures during the procedure.
Sinning JM, Hammerstingl C, Vasa-Nicotera M, Adenauer V, Lema Cachiguango SJ, Scheer AC, Hausen S, Sedaghat A, Ghanem A, Müller C, Grube E,Nickenig G, Werner N. (2012). Aortic regurgitation index defines severity of peri-prosthetic regurgitation and predicts outcome in patients after transcatheter aortic valve implantation. J Am Coll Cardiol. 2012 Mar 27;59(13):1134-41. [full abstract provided].
OBJECTIVES:
The aim of this study was to provide a simple, reproducible, and point-of-care assessment of peri-prosthetic aortic regurgitation (periAR) during trans-catheter aortic valve implantation (TAVI) and to decipher the impact of this peri-procedural parameter on outcome.
BACKGROUND:
Because periAR after TAVI might be associated with adverse outcome, precise quantification of periAR is of paramount importance but remains technically challenging.
METHODS:
The severity of periAR was prospectively evaluated in 146 patients treated with the Medtronic CoreValve (Minneapolis, Minnesota) prosthesis by echocardiography, angiography, and measurement of the aortic regurgitation (AR) index, which is calculated as ratio of the gradient between diastolic blood pressure (DBP) and left ventricular end-diastolic pressure (LVEDP) to systolic blood pressure (SBP): [(DBP – LVEDP)/SBP] × 100.
RESULTS:
After TAVI, 53 patients (36.3%) showed no signs of periAR and 71 patients (48.6%) showed only mild periAR, whereas 18 patients (12.3%) and 4 patients (2.7%) suffered from moderate and severe periAR, respectively. The AR index decreased stepwise from 31.7 ± 10.4 in patients without periAR, to 28.0 ± 8.5 with mild periAR, 19.6 ± 7.6 with moderate periAR, and 7.6 ± 2.6 with severe periAR (p < 0.001), respectively. Patients with AR index <25 had a significantly increased 1-year mortality risk compared with patients with AR index ≥25 (46.0% vs. 16.7%; p < 0.001). The AR index provided additional prognostic information beyond the echocardiographically assessed severity of periAR and independently predicted 1-year mortality (hazard ratio: 2.9, 95% confidence interval: 1.3 to 6.4; p = 0.009).
CONCLUSIONS:
The assessment of the AR index allows a precise judgment of periAR, independently predicts 1-year mortality after TAVI, and provides additional prognostic information that is complementary to the echocardiographically assessed severity of periAR.
Gotzmann M, Lindstaedt M, Mügge A. (2012). From pressure overload to volume overload: Aortic regurgitation after transcatheter aortic valve implantation. Am Heart J. 2012 Jun;163(6):903-11. [full abstract provided].
Severe aortic valve stenosis is a common valvular heart disease that is characterized by left ventricular (LV) pressure overload. A lasting effect of pressure overload is LV remodeling, accompanied by concentric hypertrophy and increased myocardial stiffness. Transcatheter aortic valve implantation (TAVI) has emerged as an alternative to surgical aortic valve replacement for patients with severe symptomatic aortic valve stenosis and high surgical risk. Although TAVI has favorable hemodynamic performance, aortic valve regurgitation (AR) is the most frequent complication because of the specific technique used for implantation of transcatheter valves.
During implantation, the calcified native valve is pushed aside, and the prosthesis usually achieves only an incomplete prosthesis apposition. As a consequence, the reported prevalence of moderate and severe AR after TAVI is 6% to 21%, which is considerably higher than that after a surgical valve replacement. Although mild AR probably has minor hemodynamic effects, even moderate AR might result in serious consequences. In moderate and severe AR after TAVI, a normal-sized LV with increased myocardial stiffness has been exposed to volume overload. Because the noncompliant LV is unable to raise end-diastolic volume, the end-diastolic pressure increases, and the forward stroke volume decreases. In recent years, an increasing number of patients have successfully undergone TAVI. Despite encouraging overall results, a substantial number of patients receive neither symptomatic nor prognostic benefits from TAVI. Aortic valve regurgitation has been considered a potential contributor to morbidity and mortality after TAVI. Therefore, various strategies and improvements in valve designs are mandatory to reduce the prevalence of AR after TAVI.
Walther T , Thielmann M, Kempfert J, Schroefel H, Wimmer-Greinecker G, Treede H, Wahlers T, Wendler O. (2012). PREVAIL TRANSAPICAL: multicentre trial of transcatheter aortic valve implantation using the newly designed bioprosthesis (SAPIEN-XT) and delivery system (ASCENDRA-II). Eur J Cardiothorac Surg. 2012 Aug;42(2):278-83. Epub 2012 Jan 30. [full abstract provided].
OBJECTIVE
Transapical (TA- aortic valve implantation (AVI) has evolved as an alternative procedure for high-risk patients. We evaluated the second-generation SAPIEN xt ™ prosthesis in a prospective multicentre clinical trial.
METHODS
A total of 150 patients (age : 81.6; 40.7 % female) were included. Prosthetic valves (diameter :23 mm (n= 36), 26 mm (n= 57) and 29 mm (n= 57) were implanted. The ASCENDRA-II™ modified delivery system was used in the smaller sizes. Mean logistic EuroSCORE was 24.3% and mean STS score was 7.5 ± 4.4%. All patients gave written informed consent.
RESULTS:
Off-pump AVI was performed using femoral arterial and venous access as a safety net. All but two patients receivec TA-AVI, as planned. The 29-mm valve showed similar function as the values of two other diameters did. Three patients (2%) required temporary bypass support.
Postoperative complications included renal failure requiring long-term dialysis in four, bleeding requiring re-thoracotomy in four, respiratory complication requiring re-intubation in eight and septsis in four patients, respectively.
Thirty day mortality was 13 ( 8.7%) for the total cohort and 2/57 (3.5%) receiving the 29 mm valve respectively. Echocardiography at discharge showed none or trivial incompetence (AI) in 71% and mild-AI in 22% of the patients. Post-implantation AI was predominantly para-valvular and > 2+ in 7% of patients. One patient required re-operation for AI within 30 days.
CONCLUSION
The PREVAIL TA multicenter trial demonstrates good functionality and good outcomes for TA-AVI, using the SAPIEN xt ™ and its second generation ASCENDRA-II™ delivery system, as well successful introduction of the 29-mm SAPIEN XT ™ valve for the benefit of high-risk elderly patients.
Subramanian S, Rastan AJ, Holzhey D, Haensig M, Kempfert J, Borger MA, Walther T, Mohr FW. (2012). Conventional Aortic Valve Replacement in Transcatheter Aortic Valve Implantation Candidates: A 5-Year Experience. Ann Thorac Surg. July 19 2012 [full abstract provided].
BACKGROUND:
Patient selection for transcatheter aortic valve implantation (TAVI) remains highly controversial. Some screened patients subsequently undergo conventional aortic valve replacement (AVR) because they are unsuitable TAVI candidates. This study examined the indications and outcomes for these patients, thereby determining the efficacy of the screening process.
METHODS:
Between January 2006 and December 2010, 79 consecutive patients (49% men), aged older than 75 years with high surgical risk, were screened for TAVI, but subsequently underwent conventional AVR through a partial or complete sternotomy. The indications, demographics, and outcomes of this cohort were studied.
RESULTS:
Mean age was 80.4 ± 3.6 years. Mean left ventricular ejection fraction was 0.55 ± 0.16, and the mean logistic European System for Cardiac Operative Risk Evaluation was 13% ± 7%. Of the 79 patients, 6 (7.6%) had prior cardiac surgical procedures. Indications for TAVI denial after patient evaluations were a large annulus in 31 (39%), acceptable risk profile for AVR in 24 (30%), need for urgent operation in 11 (14%), and concomitant cardiovascular pathology in 5 (6%). Mean cross-clamp time was 55 ± 14 minutes, and cardiopulmonary bypass time was 81 ± 21 minutes. Concomitant procedures included a Maze in 12 patients (15%). Postoperative morbidity included permanent stroke in 2 (2.5%), respiratory failure in 9 (11%), and pacemaker implantation in 2 (2.5%). Hospital mortality was 1.3% (1 of 79). Cumulative survival at 6, 12, and 36 months was 88.5%, 87.1% and 72.7%, respectively.
CONCLUSIONS:
Our existing patient evaluation process accurately defines an acceptable risk cohort for conventional AVR. The late mortality rate reflects the advanced age and comorbidities of this cohort. The data suggest that overzealous widening of TAVI inclusion criteria may be inappropriate.
Industry fights back
Now it looks like Edwards Lifesciences, the company that manufacturers the Sapien valve is speaking out to dispute recent findings that show TAVI to have less than optimal results. Of course, the author at the site, Med Latest says it best, “Setting aside the conflict of interest stuff, which might be a red-herring, what we’re left with is a situation where evidence-based medicine, while being something all would sign up to, is not that straightforward.”
[1] Several cardiologists and cardiac surgeons contributed to this article. However, given the current politics within cardiology, none of these experts were willing to risk their reputations by publically disputing the majority opinion. This is certainly understandable in today’s medico-legal climate in wake of widespread scandals and credibility issues. However, all quotes are accurate, even if unattributable with minor formatting (such as the addition of quotations, and paragraph headings have been added for increased clarity of reading in blog format.) I apologize for the ‘anonymous nature’ of my sources in this instance – however, I can assure you that these ‘experts’ know what they are talking about.
[All commentary by Cartagena Surgery are in italics and brackets].
Thanks again to ‘Lapeyre’, who as it turns out is Dr. Didier Lapeyre, a renowned, French cardiothoracic surgeon credited with the development of the first mechanical valves.
Dr. Didier Lapeyre was gracious enough to send some additional literature to add to our ongoing discussions regarding severe aortic stenosis and TAVI/ TAVR therapies. He also commented that the best way to avoid these ‘high risk situations’ is by earlier intervention with conventional surgery – something we discussed before in the article entitled, “More patients need surgery.”
He also points out that ‘elderly’ patients actually do quite well with aortic valve replacement and offers a recently published meta-analysis of 48 studies on patients aged 80 or older.
As readers know, on June 13, 2012 – the FDA ruled in favor of expanding the eligibility criteria for this therapy. Previously, this treatment modality, due to its experimental nature and high rate of complications including stroke and serious bleeding, has been limited in the United States to patients deemed ineligible for aortic valve replacement surgery.
Now on the heels of the Partner A trial, in which researchers reported favorable results for patients receiving the Sapien device, the FDA has voted to approve expanding criteria to include patients deemed to be high risk candidates for surgery. As we have discussed on previous occasions, this opens the door to the potential for widespread abuse, misapplication of this therapy and potential patient harm.
Most notably, is the evidence of widespread abuse in Germany (page 49 of report), which has become well-known for their early adoption of this technology, and now uses TAVI for an estimated 25 – 40% of valve procedures*. Closer examination of the practices in this country show poor data reporting with incomplete information in the national registry as well as a reported mortality rate of 7.7%, which is more than double that of conventional surgery. Unsurprisingly, in Germany, TAVI is reimbursed at double the amount compared to conventional surgery**, providing sufficient incentive for hospitals and cardiologists to use TAVI even in low risk patients. (and yes, german cardiologists are often citing “patient refused surgery” as their reason, particularly when using TAVI on younger, healthy, low risk patients.)
In their examination of the data itself, Mattias et al. (2011) found significant researcher bias within the study design and interpretation of results. More alarmingly, Mattias found that one of the principle researchers in the Partner A study, Dr. Martin Leon had major financial incentives for reporting successful results. He had recently received a 6.9 million dollar payment from Edward Lifesciences, the creators of the Sapien valve for purchase of his own transcatheter valve company. He also received 1.5 million dollar bonus if the Partner A trial reached specific milestones. This fact alone, in my mind, calls into question the integrity of the entire study.
[Please note that this is just a tiny summary of the exhaustive report.]
Thank you, Dr. Lapeyre for offering your expertise for the benefit of our readers!
* Estimates on the implantation of TAVI in Germany vary widely due to a lack of consistent reporting.
** At the time of the report, TAVI was reimbursed at 36,000 euros (45,500 dollars) versus 17,500 euros (22,000 dollars) for aortic valve replacement.
For more posts on TAVI and aortic stenosis, see our TAVI archive.
As reported by heartwire, and a savvy reader, Lapeyre here at Cartagena Surgery, the FDA has gone ahead and approved TAVI/ TAVR for patients that are eligible for open surgery. [We must think alike, as I was drafting this post when I received the reader mail].
Despite the FDA’s previously cited concerns over the excessive stroke rate with the Sapien device (as discussed in the article re-posted below) – the FDA approved the use of this therapy as an alternative to surgery on June 13th.
Now we can sit back and watch as the up selling of this device to the public as news hits the US media and the television advertisements begin. Soon this device will crowd out surgery as interventionalists cite “patient refused surgery” as the criteria for implantation, no matter what the best interest of the patient really is. I wonder if they will even disclose the heightened stroke rate when they start implanting this into patients at a much higher rate. Of the 12 members of the FDA panel, only one member voted against the expansion criteria.
As reported by Shelley Wood in a follow-up Heartwire article , only Dr Valluvan Jeevanandam spoke out against expanding the criteria for use, stating, “I think this is a very good technology, and it gives us an alternative to AVR surgery, and I’m sure the device will continue to get better,” Jeevanandam, a cardiovascular surgeon, told heartwire after the meeting.
“However, at the current time, compared with standard AVR, this device has a higher stroke rate and a high rate of aortic insufficiency, did not meet the criteria for noninferiority* in males, and has a high incidence of vascular complications.”
These are all issues that need to be very clearly explained to patients as part of the informed-consent process, he stressed. Otherwise, patients who are “enamored at the idea of avoiding a sternotomy” may not fully understand these risks.”
I fully concur with Dr. Valluvan Jeevanandam except that I might re-phase the term ‘enamored of.’ Actually, I think our so-called peers need to quit coercing patients by intentionally scaring them – in order to bill more procedures out of them. [Don’t believe it? Then check out Mark Midei and our overstenting archives.]
I will continue to champion well-established therapies with strong long term data. I know this will get me labeled as ‘old-fashioned’ (or worse) but as we’ve seen in cardiology – numerous times; easy is not always the best answer..
Yes, conventional surgery hurts – it’s not glamorous, it’s not pretty. But it’s (statistically) darn safe these days, and most of the surgeons doing it have done it thousands of times.. Even the bioprosthetic valves have a long durability than previously thought – meaning not everyone has to take warfarin..
We shouldn’t exploit people’s fears of surgery to use quasi-experimental procedures, no matter how “cool” they sound..
* I hope readers remember that ‘noninferiority’ is a lesser standard that superior to, or even EQUAL to..
FDA flags strokes, trial conduct, as TAVI maker seeks expanded role for Sapien – from Heartwire.com (Shelley Wood).
Gaithersburg, MD – A higher risk of stroke and differences in how patients randomized to different procedures were actually treated and evaluated within the PARTNER A trial, which compared transcatheter aortic-valve implantation (TAVI) with surgery, are issues the US Food and Drug Administration (FDA) hopes its expert advisors can help clarify in weighing the pros and cons of expanding approval of the Sapien transcatheter valve (Edwards Lifesciences) [1,2]. Those issues and others are detailed in an FDA briefing document, posted online today, that the agency’s Circulatory System Devices Panel will consider in advance of Wednesday’s meeting.
As previously reported by heartwire, the FDA last year reviewed and subsequently approved the Sapien valve and transfemoral delivery system in patients not suited to open-valve replacement, based primarily on the PARTNER B results. Wednesday’s meeting, drawing heavily on the PARTNER A results, will help the FDA decide whether to expand approval to high-risk patients who are surgery eligible and whether to approve the transapical approach also tested in PARTNER A.
In briefing documents posted online today, the FDA directed its advisors to pay special attention to a number of issues relating to trial conduct as well as patient outcomes.
In particular, the FDA review cites the “doubling” of neurological events seen in the Sapien-treated patients in the first 30 days postprocedure, with a higher stroke rate seen among transapical as compared with the transfemoral group.
The FDA documents also query “attempt-to-treat” decisions, including the higher number of patients randomized to surgery in whom no treatment was attempted; longer delays to treatment in surgical patients; and the higher number of concomitant operations seen in the surgical aortic-valve-replacement group—all factors that could have influenced adverse-event and survival rates in this group.
FDA is also asking its expert panel to weigh in on whether both the transfemoral and transapical approaches should be approved, given the numerically higher mortality in the transapically treated patients as compared with the transfemorally treated patients in the device arm.
General questions the FDA panel will be answering Wednesday include those related to the issues above, as well as to different outcomes seen in men and women, the importance of paravalvular regurgitation seen in patients treated with TAVI, valve durability, the required anticoagulation/antiplatelet regimen, and obtaining true informed consent.
Voting questions center on whether the evidence is sufficient to demonstrate safety and efficacy and whether the benefits of the new device outweigh the risks.
Industry analysts reading the tea leaves in the FDA’s review see the agency’s briefing document as largely promising, with Wells Fargo’s Larry Biegelsen predicting a “tough day, but positive panel outcome” and JP Morgan’s Michael Weinstein stating that the FDA synopsis contained “no major surprises; positive outcome expected.”
In other cardiology news,
New guidelines recommend the discontinuation of prasugrel a full seven days before surgery to prevent catastrophic bleeding complications. (The cynical side of me expects to see a bigger push by the industry to use prasugrel now that clopidogrel is generic.) Expect to see a couple more “Ask your doctor” ads..
No – I haven’t changed the name of the blog, just reflecting the nature of my current assignment. Spending some time in Interventional Cardiology this week as part of a story I am writing about chest pain emergencies for Mexico on my mind.com. Today, I checked out the cath lab at Hispano Americano Hospital. It’s a bit crowded, but all the equipment is brand-spanking new, and practically sparkling. (Don’t worry – I have photos to prove it!)
Nurses in the cath lab at Hospital Hispano Americano
Dr. Fernando Monge was kind of enough to give me a guided tour. While we were there he (assisted by Dr. Raul Aguilera) placed a stent in a patient with recurrent angina. A doctor from the ER also stopped by to have him review a couple EKGs.. I’ll post a link when the full story is done.
Also stopped in to talk to Dr. Jose Antonio Olivares Felix, MD, a general surgeon who reports to me that he is doing single port laparoscopy – so of course, that got me interested. Hoping to set a date to go to the operating room.
I’ll be spending all of tomorrow in the company of Dr. Marnes Molina, MD to learn more about some of the other stuff he’s doing in urology (and hopefully grab a picture of that green laser!)
Note: I owe Dr. Vasquez a much more detailed article – which I am currently writing – but after our intellectually stimulating talk the other day, my mind headed off in it’s own direction..
Had a great sit down lunch and a fascinating talk with Dr. Vasquez. As per usual – our discussion was lively, (a bit more lively than usual) which really got my gears turning. Dr. Vasquez is a talented surgeon – but he could be even better with just a little ‘help’. No – I am not trying to sell him a nurse practitioner – instead I am trying to sell Mexicali, and a comprehensive cardiac surgery program to the communities on both sides of the border.. Mexicali really could be the ‘land of opportunity’ for medical care – if motivated people and corporations got involved.
During lunch, Dr. Vasquez was explaining that there is no real ‘heart hospital’ or cardiac surgery program, per se in Mexicali – he just operates where ever his patients prefer. In the past that has included Mexicali General, Issstecali (the public hospitals) as well as the tiny but more upscale private facilities such as Hospital Alamater, and Hospital de la Familia..
Not such a big deal if you are a plastic surgeon doing a nip/tuck here and there, or some outpatient procedures – okay even for general surgeons – hernia repairs and such – but less than ideal for a cardiac surgeon – who is less of a ‘lone wolf’ due to the nature and scale of cardiac surgery procedures..
Cardiac surgery differs from other specialties in its reliance on a cohesive, well-trained and experienced group – not one surgeon – but a whole team of people to look out for the patients; Before, During & After surgery.. That team approach [which includes perfusionists, cardiac anesthesiologists (more specialized than regular anesthesia), operating room personnel, cardiology interventionalists and specialty training cardiac surgery intensive care nurses] is not easily transported from facility to facility.
just a couple members of the cardiac surgery team
That’s just the people involved; it doesn’t even touch on all the specialty equipment; such as the bypass pump itself, echocardiogram equipment, Impella/ IABP (intra-aortic balloon pump), ECMO or other equipment for the critically ill – or even just the infrastructure needed to support a heart team – like a pharmacy division that knows that ‘right now’ in the cardiac OR means five minutes ago, or a blood bank with an adequate stock of platelets, FFP and a wide range of other blood products..
We haven’t even gotten into such things such as a hydrid operating rooms and 24/7 caths labs – all the things you need for urgent/ emergent cases, endovascular interventions – things a city the size of Mexicali should really have..
But all of those things take money – and commitment, and I’m just not sure that the city of Mexicali is ready to commit to supporting Dr. Vasquez (and the 20 – something cases he’s done this year..) It also takes vision..
This is where a company/ corporation could come in and really change things – not just for Dr. Vasquez – and Mexicali – but for California..
It came to me again while I was in the operating room with Dr. Vasquez – watching him do what he does best – which is sometimes when I do what I do best.. (I have some of my best ideas in the operating room – where I tend to be a bit quieter.. More thinking, less talking)..
Dr. Vasquez, doing what he does best..
As I am watching Dr. Vasquez – I starting thinking about all the different cardiac surgery programs I’ve been to: visited, worked in – trained in.. About half of these programs were small – several were tiny, single surgeon programs a lot like his.. (You only need one great surgeon.. It’s all the other niceties that make or break a program..)
All of the American programs had the advantages of all the equipment / specialty trained staff that money could buy***
[I know what you are thinking – “well – but isn’t it all of these ‘niceties’ that make everything cost so darn much?” No – actually it’s not – which is how the Cardioinfantils, and Santa Fe de Bogotas can still make a profit offering world-class services at Colombian prices…]
The cost of American programs are inflated due to the cost of defensive medicine practices (and lawyers), and the costs of medications/ equipment in the United States****
the possibilities are endless – when I spend quality time in the operating room (thinking!)
Well – there is plenty of money in Calexico, California** and not a hospital in sight – just a one room ‘urgent care center’. The closest facility is in El Centro, California – and while it boasts a daVinci robot, and a (part-time?) heart surgeon (based out of La Mesa, California – 100 + miles away)– patients usually end up being transferred to San Diego for surgery.
Of course, in addition to all of the distance – there is also all of the expense.. So what’s a hard-working, blue-collar guy from Calexico with severe CAD going to do? It seems the easiest and most logical thing – would be to walk/ drive/ head across the street to Mexicali.. (If only Kaiser Permanente or Blue Cross California would step up and spearhead this project – we could have the best of both worlds – for residents of both cities..
A fully staffed, well-funded, well-designed, cohesive heart program in ONE medium- sized Mexicali facility – without the exorbitant costs of an American program (from defensive medicine practices, and outlandish American salaries.) Not only that – but as a side benefit, there are NO drug shortages here..
How many ‘cross-border’ cases would it take to bring a profit to the investors? I don’t know – but I’m sure once word got out – people would come from all over Southern California and Arizona – as well as Mexicali, other parts of Baja, and even places in Sonora like San Luis – which is closer to Mexicali than Hermasillo.. Then Dr. Vasquez could continue to do what he does so well – operate – but on a larger scale, without worrying about resources, or having to bring a suitcase full of equipment to the OR.
The Mexican – American International Cardiac Health Initiative?
But then – this article isn’t really about the ‘Mexican- American cross-border cardiac health initiative’ –
It is about a young, kind cardiac surgeon – with a vision of his own.
That vision brought Dr. Vasquez from his home in Guadalajara (the second largest city in Mexico) to one of my favorite places, Mexicali after graduating from the Universidad Autonomica in Guadalajara, and completing much of his training in Mexico (D.F.). After finishing his training – Dr. Vasquez was more than ready to take on the world – and Mexicali as it’s first full-time cardiac surgeon.
Mexicali’s finest: Dr. Vasquez, (cardiac surgeon) Dr. Campa(anesthesia) and Dr. Ochoa (thoracic surgeon
Since arriving here almost two years ago – that’s exactly what he’s done.. Little by little, and case by case – he has begun building his practice; doing a wide range of cardiovascular procedures including coronary bypass surgery (CABG), valve replacement procedures, repair of the great vessels (aneurysm/ dissections), congenital repairs, and pulmonary thrombolectomies..
Had a great day in the operating room with Dr. Cuauhtemoc Vasquez, MD the promising young heart surgeon I told you about several months ago. I have some absolutely breathtaking photos of the case – but I want to double-check with the patient before posting anything potentially revealing in such a public forum.
Todays’ surgery was at one of the public hospitals in Mexicali – and while technology was sometimes in short supply – talent sure wasn’t. I was frankly surprised at the level of skill and finesse Dr. Vasquez displayed given the fact that he is so early in his career.
Dr. Cuauhtemoc Vasquez, Cardiac surgeon
He’s also just an all-around pleasant and charming person. I know from previous encounters that he’s well-spoken, interesting, engaging and an excellent conversationalist – We didn’t talk at length on this occasion – because honestly, I really don’t like to be distracting during cases – especially since much of the discussion was in an English-heavy Spanglish.. (He is fluent in English but we both tend to slip in and out of Spanish. I mainly slip out when I start thinking in English and come across a concept that I am not sure about explaining or asking about in Spanish.**
But don’t worry – I am planning on seeing him next week – where I can hopefully lure him to lunch/ coffee or something so we have a more lengthy discussion – so I can give you all the details in a more formal fashion in a future post.
As a crazy side note – finally got that ‘great’ picture of the good doctor.. Oh, the irony – not during a thoracic case but while he was assisting Dr. Vasquez – (the good doctor is board-certified cardiothoracic surgeon, after all..) I didn’t post it here because there are some ‘patient bits’ in the photo..
**I know this can be frustrating from my experiences with my professor – but it’s also frustrating when: a. a question gets misinterpreted as a statement (because of my poor grammar) or b. misconstrued completely – which still happens pretty frequently. Luckily, people around here are awfully nice, and tend to give me the benefit of a doubt.
Also – I need to post this photo of one of my favorite operating room nurses – Lupita. (Lupita along with Carmen and Marisol) have been an absolute delight to be around even of those very first anxious days..
Lupita, operating room nurse.. Doesn’t hurt that she’s as cute as a button, eh?
Love, Life and Surgery in Latin America is now Colombian Culture & Cuisine 