Findings Published From Feasibility Study of TAVR in Low-Risk Patients
August 31, 2018—Online in Journal of the American College of Cardiology (JACC), Ron Waksman, MD, et al published findings from a prospective multicenter trial assessing the safety and feasibility of transcatheter aortic valve replacement (TAVR) with commercially available devices in low-risk patients with symptomatic severe aortic stenosis.
In JACC, the investigators concluded that TAVR is safe in low-risk patients with symptomatic severe aortic stenosis, 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.
The Low-Risk TAVR 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.
As summarized in JACC, the investigators enrolled 200 low-risk patients with symptomatic severe aortic stenosis at 11 centers to undergo TAVR. The investigators compared outcomes with an inverse probability weighting adjusted control cohort of 719 patients who underwent surgical aortic valve replacement (SAVR) at the same institutions using the STS database. The investigators reported the following:
|n = 200||n = 719|
|30-Day All-Cause Mortality||0%||1.7%|
|Permanent Pacemaker Implantation||5%||4.5%|
Additionally, in the TAVR group, there were low rates of new-onset atrial fibrillation (3%) and length of stay (2.0 ± 1.1 days). One (0.5%) TAVR patient had greater-than mild paravalvular leak and 14% of patients had evidence of subclinical leaflet thrombosis at 30 days in the TAVR group, reported the investigators in JACC.
In November 2015, MedStar Heart & Vascular Institute at MedStar Washington Hospital Center in Washington, DC, announced that the FDA granted the institution the first investigational device exemption to evaluate the safety and effectiveness of TAVR in patients with severe aortic stenosis who are at low risk for surgical mortality, with Dr. Waksman of MedStar as lead investigator.
Dr. Waksman presented an interim analysis of the study at CRT 2018, the Cardiovascular Research Technologies conference held March 3–6 in Washington, DC.