May 2nd, 2012
Real-World Experience with TAVI: Vive la France!
Richard A. Lange, MD, MBA and L. David Hillis, MD
A study of data from FRANCE 2, a prospectively maintained, multicenter registry of the French national experience with transcatheter aortic valve implantation (TAVI), has now been published in the New England Journal of Medicine. The registry captured every TAVI performed at all 34 active centers in France and Monaco; it therefore reflects “real-life” experience with TAVI in patients with severe aortic stenosis who were not candidates for surgical aortic valve replacement (AVR) because of coexisting conditions.
The procedural success rate was 97% in the 3195 patients enrolled between January 2010 and October 2011, with approximately 2/3 of patients receiving the Edwards SAPIEN device and 1/3 receiving the Medtronic CoreValve device.
|
Outcome |
Incidence |
| 1 month | |
| Death |
9.7% |
| Stroke |
3.4% |
| Periprosthetic aortic regurgitation |
64.5% |
| 1 year | |
| Death |
24.0% |
| Stroke |
4.1% |
| Periprosthetic aortic regurgitation |
66.9% |
Survival was significantly influenced by preoperative factors (NYHA class, EuroSCORE) and the presence of periprosthetic regurgitation.
We find two things interesting about this study: the procedure and the process.
Regarding the procedure, it is gratifying that the “real-world experience” parallels the results of the randomized PARTNER B trial.
Regarding the process, more than 50,000 patients have been treated by TAVI worldwide, despite the publication of only one randomized trial comparing TAVI with medical therapy in patients in whom surgery was contraindicated (PARTNER B, in 2010) and only one trial comparing TAVI with surgical aortic valve replacement in high-risk patients (PARTNER A, in 2011).
Both the Edwards SAPIEN and the Medtronic CoreValve devices gained CE Mark (abbreviation of French: Conformité Européenne, meaning “European Conformity”) approval for European commercial sales in 2007, well ahead of the randomized trial results published in 2010. The U.S. FDA approved the Edwards SAPIEN device in November 2011, after review by the Circulatory Device Panel in July 2011 (and only for patients who cannot undergo surgical AVR, not yet for those considered eligible but at high risk for surgical AVR). At this time, the Medtronic CoreValve is not FDA-approved.
The FDA approval process typically lags behind the European one by years. Do you feel safer — or shortchanged — by our device approval process?
4 Responses to “Real-World Experience with TAVI: Vive la France!”
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And a question might also be, why are the Europeans so far ahead of us with this technology?
I think the difference in the regulatory environment between the U.S. and Europe is a large part of it.
Being European myself, I agree that this is a large part of it- but it also protects the US from issues like the breast implants that now need to be removed due to lenient EU rules- as reported earlier this year
http://www.reuters.com/article/2012/01/05/us-france-implants-idUSTRE80429Z20120105
Approving a device in Europe is not similar to an FDA American approval because the reimbursement agencies in Europe do not automatically pay for new devices. The Sapien valve Genie is out of the bottle in America despite unacceptable stroke rates of 10% or more, depending on the definition used, and despite few patients truly being “inoperable”.
The CMS national coverage decision was watered down and few pre-payment audits will be performed. A true registry will not be required. The FDA label was liberal. As result, the Sapien valve will be used off label in many cases.
Meanwhile, thousands of patients will at best have a regurgitating inadequate valve and heart block. At worst, those patients will have major arterial damage, stroke and death. Stroke could be mitigated if the approval were held off until embolic protection devices were also approved. The entire procedure and most of the adverse events would be lower if the next generation smaller devices were used.
Supporters of percutaneous or trans-thoracic aortic valves say that those complications are warranted because “death was inevitable”. As a surgeon with experience in these cases, I disagree. Famed cardiac surgeon Michael DeBakey received risky aortic dissection and valve replacement at age 97 and did well, despite most surgeons labeling him as “inoperable”.
Failure of a heart valve leads to catastrophic hypotension and death. That is why surgical heart valves have the highest regulatory hurdle requiring years of long-term safety data prior to approval. How in the world have these more complicated, less reliable, catheter or trocar-based valves been approved with mere one-year follow-up data?
http://currentmedicine.tv/2012/specialties/cardiology/cardiologyinterventional/the-only-5-minutes-of-the-edwards-sapien-adcom-you-need-to-watch/