CardioExchange Archive

The FDA’s decision to release for general use the Sapien transcatheter aortic heart valve implantation (TAVI) technology ends the conflicting reports of either imminent approval or six months delay for further evaluation. This had created quite a stir.

Self-proclaimed patient advocates aver that enough vetting has occurred and decry that excessive regulatory obstruction is denying the American public the benefits of noninvasive valve replacement. They cite the safety and hemodynamic benefits reported by many European centers. And these results have accrued in very high-risk, elderly patients who MAY (my emphasis added) not have been considered as candidates for conventional open heart surgery. Moreover, they warn that the harmful effects of inordinate delay will be amplified as next generation improvements to this technology become available while USA medical practice languishes in the backwater. This point is reinforced by the recent successful implantation of a newer device that might be replaceable percutaneously. They omit to say that these three procedures were performed by American surgeons, but in Paraguay where patient consent, institutional review, and government supervision of medical standards are in essence nonexistent.

On the other side, defenders of a more measured approach defend further evaluation as necessary for patient safety. They correctly point out that TAVI is not suitable for patients with aortic insufficiency or dilated annuli or for patients needing concomitant CABG and/or other valvular repair. Accurate assessment of not just perioperative, but mid-term results, requires setting standards for patient selection, operator and institutional certification, and outcome documentation. TAVI may be noninvasive, but that does not mean it is inherently easier to perform and safer than standard valve replacement. Therefore, there is no rush to judgement.

As the antagonists hurl charge and countercharge at each other, I want to posit another lens through which to view this controversy — the present medicoeconomic state of cardiac surgery. Over the past decade, cardiac surgical volumes have diminished by at least half, primarily due to decreased surgical coronary revascularization. Concomitantly, reimbursement by insurers and government agencies has also decreased by almost the same amount (even more if adjusted for inflation). Yet, there are still over 1,000 institutions performing open heart surgery in the U.S., which has a population of  more than 300,000,000. By contrast, there are 55 centers serving the cardiac surgical needs of 85,000,000 Germans. As a consequence, only 10% of U.S. centers are “high-volume,” performing more than 450 cases per year. The 25% of “low-volume” German centers are defined as those doing fewer than 1,500 cases per year, none of which do as few as 450.

With every hospital scrambling to remain financially viable with less case load for less reimbursement, does not the potential exist for hype and marketing to supplant scientific evidence as the basis for introducing new technology? Isn’t the surgical decision-making process vulnerable to the patient desire for a procedure that is less invasive, causes no scarring and less pain, and permits faster discharge and rehabilitation? Premature release by the FDA could easily push TAVI down the slippery slope, encouraging inadequately qualified interventionists to perform procedures on patients falsely deemed at high risk due to economic concerns and the superficial attractions of the procedure.

Personally, I support a more thorough FDA review of TAVI because I am a patient advocate. Sometimes to protect the public the public must be protected from their own whims and ways.