TAVR Valve Type Can Mean the Difference in PVR, Death Risk

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PHILADELPHIA -- Operators shouldn't expect the same results from transcatheter aortic valve replacement (TAVR) using balloon-expandable versus self-expanding devices, a French registry study suggested.

From the France-TAVI registry, 3,910 people who received self-expanding TAVR valves (CoreValve or Evolut) tended to do worse than matched peers who got balloon-expandable ones (Sapien XT or Sapien 3) in terms of:

• Paravalvular regurgitation (moderate or worse) at discharge or in-hospital mortality: 19.8% vs 11.9% (RR 1.68, 95% CI 1.46-1.91)
• Paravalvular regurgitation alone: 15.5% vs 8.3% (RR 1.90, 95% CI 1.63-2.22)
• In-hospital mortality alone: 5.6% vs 4.2% (RR 1.34, 95% CI 1.07-1.66)
• All-cause mortality at 2 years: 29.8% vs 26.6% (HR 1.17, 95% CI 1.06-1.29)

Device generation made no difference on these propensity score-matched results, reported Eric Van Belle, MD, PhD, of Lille University Hospital, in a presentation at American Heart Association meeting. The results were simultaneously published in Circulation.

The difference in mortality between valve types was observed within the first 3 months; the mortality curves remaining parallel thereafter, Van Belle's group noted.

This suggests that paravalvular leaks are not behind the mortality difference, stated Ajay Kirtane, MD, of Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation in New York City.

France-TAVI included more than 12,000 people who got TAVR from 2013 to 2015 for native aortic stenosis, and had vital status available a median 20 months after TAVR.

Van Belle emphasized the need for randomized data comparing self-expanding and balloon-expandable transcatheter heart valves head-to-head.

For now, the results confirm observations going as far back as 2010-2011 in the FRANCE-2 registry, the authors noted.

"While it seems obvious that a significant proportion of patients can probably be safely treated with either a BEV [balloon-expandable valve] or a SEV [self-expanding valve], we cannot advocate that both device types are equal and can always be used interchangeably," commented Mohamed Abdel-Wahab, MD, and Holger Thiele, MD, both of Heart Center Leipzig at University of Leipzig, Germany.

"Despite the inherent differences in expansion mode, stent frame and leaflet characteristics between both device types, which do translate into some differences in hemodynamic function, paravalvular sealing and periprocedural complications, clinical outcomes and particularly mortality have been always considered comparable," they wrote in an accompanying editorial.

Expanding TAVR to low-risk and younger patients means operators now have to consider variables like durability and the possibility of repeat interventions in their device selection, according to Abdel-Wahab and Thiele.

They agreed that there is a need for more randomized data.

It was an inherent limitation that the observational data in the France-TAVI registry study may be subject to confounding despite propensity score matching, Van Belle and colleagues acknowledged.

"It's not clear to me whether there were differences between sites, operators, and even specific patients that led to the implantation of one specific valve over the other," Kirtane, who was not involved in the study, told MedPage Today.

That the investigators relied on site-reported paravalvular leak was also problematic given that the leakage can look different between different valve designs, he added.