SAN FRANCISCO – Among high-risk and inoperable patients with aortic stenosis (AS), transcatheter aortic valve replacement (TAVR) with the Sapien 3 (Edwards Lifesciences, Irvine, CA) valve led to an overall 1-year survival of more than 85%, as well as a low rate of 30-day complications.

“The combination of the new design features of Sapien 3, procedural improvements, operator experience, and improved patient selection have all contributed to a low rate of important adverse events (including stroke) and a high rate of 1-year survival in these high-risk and inoperable patients,” Howard C. Herrmann, MD, study investigator, said at a press conference at the 2015 Transcatheter Cardiovascular Therapeutics (TCT) annual meeting in San Francisco.

Herrmann, of the University of Pennsylvania in Philadelphia, PA, presented results of the SAPIEN 3 study, which is a single-arm, nonrandomized cohort of the PARTNER II trial evaluating the Sapien 3 transcatheter valve.


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At the American College of Cardiology (ACC) Scientific Sessions in 2015, investigators reported 30-day outcomes of the study, demonstrating a very low rate of adverse events with the next-generation transcatheter valve, according to Herrmann.

For the current analysis, Dr. Herrmann and colleagues looked at 1-year outcomes with the transcatheter valve. The study included 583 high-risk or inoperable patients who received transfemoral (84%), transapical (10%) or transaortic (6%) TAVR. Patients had a mean age of 82 years and 58% were male.

At 1 year, overall survival was 85.6%—87.3% in high-risk patients and 82.3% in inoperable patients. In the transfemoral cohort, survival was 89.3% for high-risk patients and 84.3% for inoperable patients.

“There’s been about a 50% reduction in mortality since the days of PARTNER I,” Herrmann said.

In other 1-year data, disabling stroke, defined as a modified Rankin score ≥2, was 2.4%, with no differences reported between the transfemoral, transapical and transaortic cohorts, and between high-risk and inoperable patients. There were also significantly fewer patients with New York Heart Association class 3 or 4 heart failure at 1 year vs. baseline (7.7% vs. 90.1%).

Furthermore, at 30 days, no patients had severe paravalvular regurgitation (PVR) and only 2.5% had moderate PVR.

“These excellent 1-year follow-up data with Sapien 3 support the use of TAVR as the preferred therapy in high-risk and inoperable patients with AS,” Herrmann concluded, adding that the 1-year outcomes of the SAPIEN 3 study in the intermediate-risk cohort will be presented at ACC Scientific Sessions in 2016.

Disclosures: Dr. Howard C. Herrmann received honoraria from Edwards Lifesciences (Irvine, CA).

References

1. Herrmann HC et al. Late-Breaking Trials and First Report Investigations IV. Presented at: 27th Annual Transcatheter Cardiovascular Therapeutics scientific symposium; October 10-15, 2015; San Francisco.