Conference Coverage
SAN DIEGO – Three separate reports of pivotal trial results from three different systems for performing transcatheter aortic valve replacement performed during three distinct periods highlighted the rapid advances of this intervention that have now put it on the cusp of being the preferred, default strategy for replacing stenosed aortic valves in older patients.
First SAPIEN 3 U.S. outcomes reported
The most recent technologic advance in transcatheter aortic valve replacement (TAVR), showcased in one of the three presentations at the annual meeting of the American College of Cardiology, was the SAPIEN 3 System, the lowest-profile TAVR system so far to undergo U.S. testing with a 14F delivery system for all valve sizes except the largest, 29 mm valves, which require a 16F system. SAPIEN 3 produced 30-day outcome results so good that one TAVR operator expressed shock at the dramatic, short-term success.
Mitchel L. Zoler/Frontline Medical News
Dr. Susheel K. Kodali
After 30 days follow-up, SAPIEN 3 produced a 2% mortality rate and a 2% stroke rate in 583 “high-risk” patients treated during 2013 and 2014 who were an average of 83 years old and had an average Society of Thoracic Surgeons (STS) risk score of 8.6%, Dr. Susheel K. Kodali reported at the meeting. By contrast, in the pivotal trial of the first-generation SAPIEN TAVR system, run during 2007-2009, in 348 “high-risk” patients (who averaged 84 years old and had an average STS risk score of 11.8%) the 30-day mortality ran 5% and 30-day strokes affected 6%, Dr. Kodali noted.
The new trial also enrolled 1,076 “intermediate”-risk patients, who averaged 82 years old with an average STS score of 5.3%. Their 30-day mortality rate was 1% and their total stroke rate was 3%, with a disabling stroke rate (modified Rankin scale score of 2 or more) of 1%.
Edwards Lifesciences
Sapien 3 transcatheter valve
These excellent results prompted Edwards, the company developing the SAPIEN 3 System, to apply for Food and Drug Administration approval for the device in high-risk patients, Dr. Kodali noted. In March, Edwards released a statement in which it said it expects SAPIEN 3 to receive U.S. marketing approval within a year. While Dr. Kodali said longer-term follow-up is needed for the intermediate-risk patients, the outcome results he has seen make him rethink the TAVR’s role, compared with conventional aortic valve replacement by open surgery.
“With surgery, these [intermediate-risk] patients would have a 5% mortality rate. The conversation now may need to change,” he said. “We have always said we use TAVR when surgery is not a good option, but based on the recent, 2-year findings with the CoreValve and our data, with a 1% mortality and a 1% disabling stroke rate [in intermediate-risk patients] maybe TAVR is now the preferred option, at least for 80-year-olds, said Dr. Kodali, codirector of the Heart Valve Center at NewYork-Presbyterian/Columbia University Medical Center.
Commenting on the SAPIEN 3 results as well as excellent 2-year results from the CoreValve TAVR System pivotal trial, Dr. Jeffrey J. Popma attributed the success to three factors: improved patient selection, refined and routinely used imaging methods for sizing the aortic annulus to better match the TAVR valve size to the annulus size, and improved TAVR techniques based on what is now about an 8-year clinical experience using TAVR.
Mitchel L. Zoler/Frontline Medical News
Dr. Jeffrey J. Popma
“All this now puts us in a place where the bar has been set very high for surgery. How does surgery compete?” asked Dr. Popma, professor of medicine at Harvard University and an interventional cardiologist at Beth Israel Deaconess Medical Center in Boston. “The results are so clean at 30 days, what more information do we really need” for device approval? Dr. Popma, one of the discussants for the meeting report by Dr. Kodali, asked.
“I’m shocked the SAPIEN 3 data were so good,” said Dr. Stephen Ramee, an interventional cardiologist and medical director of the Structural and Valvular Heart Center at the Ochsner Medical Center in New Orleans. “We’ll need to wait to do intermediate-risk patients routinely, but the handwriting is on the wall with these data and the CoreValve results. I think TAVR will be preferred for all high-risk patients and for intermediate-risk patients who are at least 80 years old,” Dr. Ramee said in an interview.
Commenting on whether the FDA should approve SAPIEN 3 based on 30-day outcomes in high-risk patients, Dr. Popma noted that SAPIEN 3 is “an iteration of what has been demonstrated” in long-term results with the first-generation SAPIEN device. “Do we really need a randomized clinical trail with several thousand patients after the [SAPIEN] platform was already established?” he asked.
