SAN FRANCISCO – The safety and efficacy of transcatheter aortic valve replacement keeps improving, with 1-year follow-up now available for two most-advanced systems on the U.S. market showing unprecedentedly low mortality and stroke rates in high-risk patients.
Continued improvements in safety and efficacy had cardiologists declaring that transcatheter aortic valve replacement (TAVR) is now the preferred strategy over surgery.
TAVR “should have a class I indication for high-risk patients as an alternative to surgery. That change needs to be made” based on the new data reported at the Transcatheter Cardiovascular Therapeutics annual meeting, said Dr. Martin B. Leon, director of the Center for Interventional Vascular Therapy of Columbia University in New York. TAVR currently has a class IIa recommendation as a “reasonable alternative” to surgery in patients at high surgical risk in the latest U.S. recommendations for treating aortic stenosis that came out in 2014.
One-year follow-up of 492 high-risk or inoperable patients who underwent TAVR with the SAPIEN 3 device system – the newest model from the SAPIEN series of TAVR systems and one of two next-generation systems now on the U.S. market – showed a 14% overall mortality rate and 2% stroke rate, Dr. Howard C. Herrmann reported at the meeting sponsored by the Cardiovascular Research Foundation. A combination of factors likely explained these strikingly low rates, including more refined patient selection, new device features, improved placement techniques, and more extensive operator experience, said Dr. Herrmann, professor and director of the cardiac catheterization laboratory at the University of Pennsylvania in Philadelphia.
The 1-year mortality rate of 14% in the SAPIEN3 (Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve) study ran roughly half the rate seen in the large-scale test of the first-generation SAPIEN TAVR system, a study that began nearly 10 years ago (N Engl J Med. 2011 Jun 9;364:2187-98). The 30-day results from this unblinded series of more than 500 patients treated with the SAPIEN 3 system, reported last Spring, led to Food and Drug Administration approval of the SAPIEN 3 system for U.S. marketing last June.“Our confidence in calling TAVR the preferred strategy just gets stronger when we have data like these,” commented Dr. Jeffrey J. Popma, professor at Harvard Medical School and director of interventional cardiology at Beth Israel Deaconess Medical Center in Boston.
“The data show that TAVR is getting better,” said Dr. Samir Kapadia, professor and head of interventional cardiology at the Cleveland Clinic in Cleveland.
Similar 1-year results, though from many fewer patients, also came out at the meeting for the other next-generation TAVR system on the U.S. market, Evolut R, also approved by the FDA last June. Those data showed a 1-year mortality rate of 7% and a disabling stroke rate of 3% among 60 patients who had been treated with the Evolut R TAVR system.
Another notable finding from the SAPIEN 3 results was a moderate paravalvular leak (PVL) rate of 3% after 30 days and 4% after 1 year. No patients had a severe PVL at either 30 days or 1 year; the mild PVL rate at 1 year was 34%, and 62% had none or trace PVL. “The PVL rates are really dramatic,” commented Dr. Popma.
An analysis that correlated PVL severity at 30 days and mortality at 1 year showed that mild PVL linked with 14% mortality, essentially identical to the 12% mortality in patients with no or trace PVL after 30 days. In contrast, the 16 patients with moderate PVL after 30 days had a substantially increased 38% 1-year mortality, highlighting a patient subset that needs additional interventions.
“We need to look at these cases carefully” and determine what issues are causing more severe PVLs, said Dr. Herrmann. “We need to have no moderate PVLs.”
SAPIEN3 was sponsored by Edwards Lifesciences. Dr. Herrmann has received honoraria and research grants from Edwards as well as research grants from several other companies. He also own equity in Microinterventional Devices. Dr. Popma has been a consultant to Abbott Laboratories, Boston Scientific, and STENTYS, and he has been a speaker for Medtronic, Abbott Laboratories, Boston Scientific, Covidien, Cook Medical, and Direct Flow. Dr. Leon has been a consultant to Edwards. Dr. Kapadia had no disclosures.
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