Third-generation balloon-expandable TAVR system linked to lower death, stroke rates

Issue: April 2015

SAN DIEGO — The third generation of a balloon-expandable transcatheter aortic valve replacement system showed favorable 30-day outcomes compared with previous generations, according to findings presented at the American College of Cardiology Scientific Sessions.

Perspective from Howard C. Herrmann, MD

In the PARTNER II S3 trials, the TAVR system (Sapien 3, Edwards Lifesciences) was associated with lower rates of death, stroke and paravalvular leak at 30 days compared with earlier-generation devices in patients at high risk for surgery, and showed encouraging results in intermediate-risk patients, Susheel Kodali, MD, director of the heart valve center at Columbia University Medical Center/New York–Presbyterian Hospital, said at a press conference.

Susheel Kodali

Kodali and colleagues enrolled 1,076 intermediate-risk patients (mean age, 81.9 years; 62% men) and 583 high-risk or inoperable patients (mean age, 82.6 years; 58% men) with symptomatic severe aortic stenosis in a nonrandomized study to assess the safety and efficacy of the Sapien 3 system.

The major advances of the Sapien 3 system are an outside cuff designed to provide a better seal to reduce paravalvular leak and the ability to be used with a sheath as small as 14F, Kodali said.

At 30 days in the high-risk cohort, the all-cause mortality rate was 2.2%, the CV mortality rate was 1.4%, the overall stroke rate was 1.5% and the disabling stroke rate was 0.9%.

At 30 days in the intermediate-risk cohort, the all-cause mortality rate was 1.1%, the CV mortality rate was 0.9%, the overall stroke rate was 2.6% and the disabling stroke rate was 1%.

Most rates were lower in patients who had the procedure via transfemoral access (all-cause mortality, 1.6%; CV mortality, 1%; overall stroke, 1.1%; disabling stroke, 0.9%) compared with transapical or transaortic access (all-cause mortality, 5.4%; CV mortality, 3.3%; overall stroke, 1.6%; disabling stroke, 0.8%). “We have seen data showing that if you avoid a thoracic approach, outcomes are better,” he said.

In comparison, 30-day all-cause mortality rates were 5.2% for all patients treated with TAVR in the PARTNER IA trial, 3.7% for those treated transfemorally in PARTNER 1A, 8.7% for those treated transapically in PARTNER 1A, 6.5% for those treated transfemorally in PARTNER 1B, 4.5% for those treated transfemorally in PARTNER IIB, 8.1% for those treated transapically in PARTNER IIB, 6.5% for those treated transaortically in PARTNER IIB and 3.5% for those treated transfemorally in PARTNER IIB XT, according to Kodali.

He added that 30-day stroke rates in the PARTNER I and PARTNER II trials ranged from 4.1% to 6.7%.

At 30 days, 55% of the PARTNER II S3 cohort had no or trace evidence of paravalvular leak, 41.3% had mild paravalvular leak, 3.7% had moderate paravalvular leak and 0.1% had severe paravalvular leak, Kodali said. The rate ranged from 11.5% to 24.2% in previous PARTNER trials, according to the researchers.

“These are patients [who] in surgery would have a 5% mortality rate,” he said. “Now the conversation needs to change. Maybe TAVR is the preferred option, at least in 80-year-olds. How much long-term data do we need before we get this device approved for this indication?” – by Erik Swain

Reference:

Kodali S. Late-Breaking Clinical Trials III. Presented at: American College of Cardiology Scientific Sessions; March 14-16, 2015; San Diego.

Disclosure: The study was funded by Edwards Lifesciences. Kodali reports receiving research/grant support from Boston Scientific, Claret Medical, Edwards Lifesciences and Medtronic; serving on steering committees for Claret Medical, Edwards Lifesciences and Meril; holding equity in Thubrikar Aortic Valve Inc.; and receiving honoraria from Claret Medical and St. Jude Medical.

Perspective

Howard C. Herrmann, MD

Overall, Sapien 3 showed an impressive outcome in terms of mortality, stroke and vascular complication rates. The results show that there has been considerable evolution in the devices for TAVR as well as in operator experience. Outcomes are continuing to improve on all fronts, based on that combination of factors. I don't think we should attribute the great outcomes only to the valve, but also to what we have learned about how to do TAVR better.

I can’t wait to see the longer-term results, as 1 year was the primary endpoint. I also can’t wait to see the comparison of the intermediate-risk group with the surgical arm and the Sapien XT arm of PARTNER IIA, which is the approval cohort study for Sapien 3 in intermediate-risk patients.

Howard C. Herrmann, MD

Cardiology Today's Intervention Editorial Board member

Director, Interventional Cardiology Program and Cardiac Catheterization Laboratories, University of Pennsylvania

Disclosures: Herrmann reports that his institution received research funding from Edwards Lifesciences for his role as an investigator in the SAPIEN 3 trial, and reports consulting for Edwards Lifesciences.