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TAVR Holds Up At 1 Year in Low-Risk Patients

WASHINGTON — Transcatheter aortic valve replacement (TAVR) continued to be safe and effective in younger, low-risk patients at 1 year in the LRT study.

Deaths and strokes rose from none at 30 days to 3.0% and 2.1%, respectively, a year after the procedure, but that was still lower in terms of mortality than seen in the higher-risk trials, Ron Waksman, MD, of MedStar Washington Hospital Center, reported here at the Cardiovascular Research Technologies (CRT) conference.

Hemodynamics at 1 year also showed patients maintaining the reduced gradients achieved immediately after TAVR, whereas aortic valve area fell slightly from 30 days.

But as was the case with the 30-day results presented last year, subclinical leaflet thrombosis remained a concern as 14.0% of patients developed hypo-attenuated leaflet thickening in the year following TAVR. Such degeneration was seen only with balloon-expandable devices and was more common in patients who were off oral anticoagulation.

“TAVR is safe and effective in low-risk patients with low adverse event rates and excellent valve hemodynamics at 1 year,” Waksman concluded. “If the pivotal trials corroborate the LRT results then TAVR should be approved for low-risk patients.”

It is unclear what the long-term significance is of the observed 14% rate of subclinical valve thrombosis, commented Michael Mack, MD, of Baylor Scott & White The Heart Hospital – Plano, Texas, who was not involved in the study.

“In general, I think you can conclude that TAVR is safe in low-risk patients. We knew that already from the 30-day data that was presented from this nonrandomized study last year. The problem with effectiveness is that we only have 1 year data and the major effectiveness question is going to be durability in younger low-risk patients,” Mack told MedPage Today.

Faced with the choice of the transcatheter or the surgical option, Waksman said at a CRT press conference that he “would choose TAVR definitely” now without waiting 10 years for the durability data.

In 2 weeks at the American College of Cardiology meeting, 1-year data will be presented from two trials of TAVR in low-risk patients — PARTNER 3 and CoreValve Low Risk.

The LRT investigators are currently enrolling for the randomized LRT 2.0 trial that will test whether routine anticoagulation after TAVR prevents leaflet thrombosis.

The 200 TAVR patients in the LRT study all had symptomatic severe aortic stenosis. The average age was 71.7 years, and the mean STS score for surgical valve replacement was 1.7%. Among the exclusion criteria were frailty, severe coronary artery disease, and prior heart surgery.

The procedure was done with general anesthesia in a quarter of cases, with transfemoral access in all cases. Most got the balloon-expandable Sapien 3 valve (88.2%), and the rest got the self-expanding Evolut R or Pro.

New-onset atrial fibrillation and permanent pacemaker implantation occurred in 6.3% and 7.3% of patients, respectively, at 1 year. Another 1.5% came back with moderate or severe paravalvular aortic regurgitation.

This TAVR cohort is to be compared with a historical surgical valve replacement cohort in the future.

The LRT trial received no outside funding.

Waksman disclosed financial ties with Boston Scientific, Biotronik, Biosensors, AstraZeneca, Medtronic, Abbott Vascular, Symetis, Med Alliance, LifeTech, and Amgen.