Readers write in: TAVI


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.

In the accompanying 114 page article, “Transcatheter aortic valve implantation (TAVI): a health technology assessment update,” Belgian researchers (Mattias, Van Brabandt, Van de Sande & Deviese, 2011) looking at transcatheter valve procedures have found exactly that in their examination of the use of TAVI worldwide.

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.

References

Mattias, N., Van Brabandt, H., Van de Sande, S. & Deviese, S. (2011).  Transcatheter aortic valve implantation (TAVI): a health technology assessment .  Belgian Health Care Knowledge Centre.

Vasques, F., Messori, A., Lucenteforte, E. & Biancari, F. (2012).  Immediate and late outcome of patients aged 80 years and older undergoing isolated aortic valve replacement: a systematic review and meta-analysis of 48 studies.  Am Heart J 2012; 163: 477-85.

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Blue Cross/ Blue Shield of Mexicali & Dr. Cuauhtemoc Vasquez Jimenez


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..

Dr. Vasquez, Mexicali’s cardiac surgeon

Dr. Cuauhtemoc Vasquez Jimenez, MD

Cardiac Surgeon

Calle B No. 248 entre Obregon y Reforma

Col. Centro, Mexicali, B. C.

Email: drcvasquez@hotmail.com

Tele: (686) 553 – 4714 (appointments)

Notes:

*The Imperial Valley paper reports that Calexico makes 3 million dollars a day off of Mexicali residents who cross the border to shop.

***In all the programs I visited  – there are a couple of things that we (in the United States do well..  Heart surgery is one of those things..)

**** Yes – they charge us more in Calexico for the same exact equipment made in India and sold everywhere else in the world..