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February 24, 2020

Thirty-Day Data From Low-Risk TAVR Trial Published and Presented

February 24, 2020—Online in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions, Ron Waksman, MD, et al published findings from a study of transcatheter aortic valve replacement (TAVR) in low-risk patients with symptomatic severe bicuspid aortic valve stenosis. The study was presented at the 2020 CRT Congress held February 22–25 in National Harbor, Maryland.

As summarized in JACC: Cardiovascular Interventions, investigators in the Low-Risk TAVR (LRT) trial aimed to evaluate the clinical outcomes and transcatheter heart valve hemodynamics after TAVR in low-risk bicuspid aortic stenosis (AS) patients. The background of the study is that patients with bicuspid AS were excluded from the randomized cohorts of the pivotal low-risk trials that supported the approval of TAVR for low-risk patients in the United States.

The LRT trial was an investigator-initiated, prospective, multicenter study conducted under an FDA-approved investigational device exemption to evaluate the feasibility of TAVR with either balloon-expandable or self-expanding valve in low-risk bicuspid AS patients.

The primary endpoint was all-cause mortality at 30 days. Baseline and follow-up echocardiography and CT to detect leaflet thickening were analyzed in an independent core laboratory. The study was composed of 61 low-risk patients with symptomatic, severe AS and bicuspid aortic valves (78.3% Sievers type 1 morphology) who underwent TAVR at seven centers from 2016 to 2019. The mean age of the patients was 68.6 years and 42.6% were men.

The investigators reported in JACC: Cardiovascular Interventions that the 30-day findings included the following:

  • Zero instances of mortality
  • Zero cases of disabling stroke
  • A 13.1% rate of implantation of new permanent pacemakers
  • One patient had a moderate paravalvular leak
  • 10% of patients had hypoattenuated leaflet thickening

The investigators concluded that TAVR appears to be safe in bicuspid AS patients, with short hospital length of stay, zero mortality, and zero disabling strokes at 30 days. Subclinical leaflet thrombosis was observed in a minority of patients at 30 days but did not appear to be associated with clinical events, advised the investigators in JACC: Cardiovascular Interventions.

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