TAVR Devices Keep Changing -- Is This Really Helping Patients?

CHICAGO -- Tweaks made to Medtronic's CoreValve transcatheter heart valve (THV) line in the last few years have tracked with some improved outcomes after transcatheter aortic valve replacement (TAVR), but it's still not clear that newer devices are necessarily better without firmer goalposts throughout the industry.

Technical success of TAVR stayed stable from the early days of Evolut PRO (Q1; August 2017 to June 2018) to a recent period of wider use of Evolut PRO+ (Q4; September 2020 to November 2021), according to NEOPRO and NEOPRO-2 registry data reported by Andrea Scotti, MD, of Montefiore Medical Center and Albert Einstein College of Medicine in New York City.

During this period, significant gains were made in 30-day VARC-3-defined early safety (from 67% in Q1 to 78% in Q4) and device success (from 81% to 88%). Moderate or severe paravalvular leak was reduced significantly (from 5% to 2%), and permanent pacemakers also dropped (from 15% to 12%).

Although the latter complication stayed at a double-digit rate, the overall data are encouraging, Scotti said during his presentation at the Transcatheter Valve Therapeutics (TVT) conference hosted by the Cardiovascular Research Foundation.

Permanent pacemaker implantation has been linked to more complications after TAVR, longer hospital stays, and higher societal costs -- though its association with early mortality and heart failure has been less convincing.

Notably, CoreValve's latest iteration, Evolut FX, was not captured in the present study. FX keeps the same supra-annular valve design of its predecessors and adds new gold markers to provide operators with direct visualization of depth and valve leaflet location during implant, as well as a redesigned catheter tip and more flexible delivery system. FDA approved this newcomer in August 2021.

TAVR with the not-so-new Evolut PRO and PRO+ resulted in 1-year outcomes of death in 10%, cardiovascular death in 5%, and death or cardiovascular hospitalization in 16%, according to Scotti's study.

He acknowledged that strokes and left bundle branch block were not counted due to incomplete data from participating centers.

This prompted a discussion at TVT on the challenges of conducting pragmatic research in TAVR nowadays and knowing if one device is really better than another.

"Techniques have changed, patients have changed, there's incomplete data, the definitions are different ... What is the right approach?" asked Samir Kapadia, MD, of Cleveland Clinic. He suggested this is an especially important question when comparing hemodynamics, which can make or break a device's prospects.

One suggestion is to have a big professional society come out and require study sponsors and sites to adhere to set standards of reporting. "That is the only way forward that I see," said Jeroen Bax, MD, PhD, of Leiden University Medical Center in the Netherlands.

Fellow panelist Scott Lim, MD, of the UVA Advanced Cardiac Valve Center in Charlottesville, Virginia, recalled the early promise that electronic medical records would allow the sharing of data, such as electrocardiograms from any patient in a clinical trial.

"We still haven't realized this promise," he complained. "We're trying to Band-Aid it with the TVT Registry, but we still need to do better."

For the analysis, Scotti's group relied on the NEOPRO and NEOPRO-2 registries and analyzed 1,616 people who underwent TAVR for severe aortic stenosis and received Evolut PRO and PRO+ self-expanding THVs.

These patients had an average age of 81.7 years, and 39.1% were women.

The cohort was divided into quarters according to when TAVR was performed during the study period. From Q1 to Q4, patients were less sick at baseline but procedures were increasingly complex due to more calcified anatomy.

"Evolut is a sort of ongoing journey, unlike Sapien which we basically implant the same [as previous] years," commented Ran Kornowski, MD, of Rabin Medical Center in Petah Tikva, Israel, during the discussion at TVT.

He said some trends in the present analysis were not necessarily significant but it was important to show the patient population changing.

The original CoreValve was first to be FDA approved in 2014. Several generations later, Evolut PRO was approved in March 2017 and Evolut PRO+ in September 2019.

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