Mayo Clinic study finds TAVI usage requires a lot of practice

Transcatheter aortic valve implantation has been hailed as an exciting technology able to treat acute cardiac stenosis in patients who cannot undergo open-heart surgery.

But now the Mayo Clinic has found that the procedure requires a lot of practice. And that raises the question of how widely the nascent technology will be adopted in the U.S. and whether doctors would need credentials to perform the procedure.

Heart.org reported that the Mayo study found that doctors may require as many as 30 procedures before they reach proficiency in using TAVI.The study was part of Edwards Lifesciences’ Partner Trial and was based on observing 44 patients who underwent transcatheter aortic valve replacement at the Mayo Clinic in Rochester, Minnesota between November 2008 and May 2011. Edwards Lifesciences is the first company in the U.S. to receive regulatory approval to market its transcatheter aortic valve replacement system called Sapien.

In an editorial published along with the study in the December issue of theJournal of the American College of Cardiology: Cardiovascular Interventions, editorPeter Block highlighted the complex learning curve and speculated about TAVI’s rollout.

“How all this will play out over the next year should concern every center and operator contemplating the addition of TAVI to their list of available therapies,” he wrote. “[I]t may take more than a full year for an operator to become procedure ‘proficient,’ [and] the question of maintenance of proficiency is totally unanswered at present.”

This conclusion, if widely held, may ultimately affect companies who have developed TAVI systems

While Edwards Lifesciences with its Sapien is the only company with an approved product in the U.S., Medtronic was the first to win regulatory approval for a TAVI system in Europe and other nations. Called CoreValve, the system has reported positive clinical outcomes in a study following patients in Europe and Canada. A clinical trial is currently under way in the U.S. to test the device.

On Tuesday, a Medtronic spokeswoman acknowledged that “weare aware of the learning curve and accommodate it through rigorous physician education. …”

That training includes “hands-on training featuring state of the art simulation … (and) proctored case support that is led by skilled physician proctors who have both depth and breadth of experience with the CoreValve System in countries where the CoreValve System is commercially available,” said Kathleen Janasz, a Medtronic spokeswoman.

Janasz’s comments were echoed by anEdwards spokeswoman.

“Edwards has designed a robust training program that is tailored to the needs of the Heart Teams performing TAVR [transcatheter aortic valve replacement], enabling teams to develop a high level of comfort with this new procedure,” said Sarah Huoh. “We believe the results from The Partner Trial, which include this experience from the Mayo Clinic, will drive adoption of TAVR and [we] have confidence in the plans we have in place for the U.S. introduction of this new therapy.”

CoreValve and Sapien will vie for a target population of 100,000 Americans who suffer from severe aortic stenosis.