Indexed on: 01 Sep '18Published on: 01 Sep '18Published in: JACC (Journal of the American College of Cardiology)
Transcatheter aortic valve replacement (TAVR) is now standard of care for patients with symptomatic severe aortic stenosis who are extreme, high or intermediate risk for surgical aortic valve replacement (SAVR). To evaluate TAVR in a prospective multicenter trial involving low-risk patients. The Low Risk TAVR trial was the first FDA-approved Investigational Device Exemption trial to enroll in the US. This investigator-led trial was a prospective, multicenter, unblinded, comparison to historical controls from the Society of Thoracic Surgeons (STS) database. The primary endpoint was all-cause mortality at 30 days. We enrolled 200 low-risk patients with symptomatic severe aortic stenosis at 11 centers to undergo TAVR. We compared outcomes with an inverse probability weighting adjusted control cohort of 719 patients who underwent SAVR at the same institutions using the STS database. At 30 days, there was zero all-cause mortality in the TAVR group versus 1.7% mortality in the SAVR group. There was zero in-hospital stroke in the TAVR group versus 0.6% stroke in the SAVR group. Permanent pacemaker implantation rates were similar between TAVR and SAVR (5.0% versus 4.5%). The rates of new onset atrial fibrillation (3.0%) and length of stay (2.0±1.1days) were low in the TAVR group. One patient (0.5%) in the TAVR group had >mild paravalvular leak at 30 days. Fourteen percent of TAVR patients had evidence of subclinical leaflet thrombosis at 30 days. TAVR is safe in low-risk patients with symptomatic severe aortic stenosis, with low procedural complication rates, short hospital length of stay, zero mortality, and zero disabling stroke at 30 days. Subclinical leaflet thrombosis was observed in a minority of TAVR patients at 30 days. Copyright © 2018. Published by Elsevier Inc.