Safety and Performance Outcomes Published for Biotronik's Biovalve TAVR Device

October 18, 2019—In Journal of the American College of Cardiology (JACC): Cardiovascular Interventions, Ulrich Schäfer, MD, et al published findings from the first-in-human BIOVALVE I and II studies of the safety and performance of the newly introduced Biovalve transfemoral self-expanding supra-annular transcatheter heart valve (Biotronik).

BIOVALVE-I is a prospective, single-center feasibility study enrolling 13 high-risk patients with severe aortic stenosis, and BIOVALVE-II is a multicenter pilot study enrolling a further 55 patients under the same protocol. Patients’ mean age was 82.4 ± 5.3 years, 57.4% had concomitant coronary artery disease, 50% had renal insufficiency stage ≥ 3, 32.4% had diabetes mellitus, 29.4% had current anemia, 19.1% had chronic obstructive pulmonary disease, 19.1% were frail, and 17.6% had prior cerebrovascular events.

As summarized in JACC: Cardiovascular Interventions, the primary endpoint—early safety according to the Valve Academic Research Consortium-2 guidelines—was observed in 13 (19.1%) patients.

The investigators found the following at 30 and 180 days, respectively:

• Noncardiac death in one (1.5%) and four (7.8%) patients
• Disabling stroke in one (1.5%) and two (3.2%) patients
• Moderate or severe paravalvular leakage in two (3.8%) and four (9.1%) patients
• Mean effective orifice area was 2.0 ± 0.4 and 1.9 ± 0.5 cm²
• The mean gradient was 6.4 mm Hg at both intervals

Additionally, new permanent pacemakers were implanted in nine (13.4%) patients at 30 days.

The clinical outcomes with the Biovalve self-expanding transcatheter heart valve were similar to those seen in other first-in-human studies with first-generation devices for severe aortic stenosis, concluded the investigators in JACC: Cardiovascular Interventions.