Early Results Presented From Low-Risk TAVR Study

March 5, 2018—Ron Waksman, MD, presented an interim analysis of a study assessing the safety and feasibility of transcatheter aortic valve replacement (TAVR) with commercially available valves in patients with symptomatic severe aortic stenosis who are at low risk (Society of Thoracic Surgeons score ≤ 3%) for surgical aortic valve replacement (SAVR). The data were presented at CRT 2018, the Cardiovascular Research Technologies conference held March 3–6 in Washington, DC.

In November 2015, MedStar Heart & Vascular Institute at MedStar Washington Hospital Center in Washington, DC, announced that the US Food and Drug Administration 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.

According to Dr. Waksman, these findings are for the first 125 patients enrolled in the study, which has a total of 221 patients; full trial results will be available later this year.

As reported by CRT, the findings from the low-risk TAVR data showed generally positive results with low-risk patients undergoing TAVR having no mortality and no disabling stroke at 30 days and low rates of major adverse events at 30 days. Additionally, subclinical leaflet thrombosis was present in low-risk patients and showed a higher incidence on antiplatelet therapy without additional anticoagulation.

Dr. Waksman noted that several low-volume centers are part of the study and still have very low event rates at 30 days including need for new permanent pacemaker.

Toby Rogers, MD, commented that the presence of low-volume centers "shows this is a real-world study of low-risk TAVR." He added, "It's not just the expert centers; it's centers that don't have the experts, and yet the results are really excellent." Dr. Rogers is also with MedStar Washington Hospital Center, which is a high-volume TAVR center.

"I agree," stated Dr. Waksman. "And even though this is considered by a feasibility/safety study, I would say that, carefully, that's what you probably are going to see in the large trials. There's no reason why it should be much different."