One-Year REPRISE II Data Published for Boston Scientific's Lotus TAVR Device in High-Risk Patients With Severe Aortic Stenosis

February 15, 2016—Ian T. Meredith, MD, et al published the 1-year outcomes of the 120 patients enrolled in the REPRISE II study in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2016;9:376–384). REPRISE II is evaluating the fully repositionable and retrievable Lotus valve (Boston Scientific Corporation), which is designed to facilitate accurate positioning, early valve function, and hemodynamic stability during deployment, and to minimize paravalvular regurgitation in patients undergoing transcatheter aortic valve replacement.

The RERPISE II investigators concluded that at 1-year follow-up, the Lotus valve demonstrated excellent valve hemodynamics, no moderate or severe paravalvular regurgitation, and significant and sustained improvement in New York Heart Association functional class status, with good clinical outcomes.

As summarized in JACC: Cardiovascular Interventions, the REPRISE II study enrolled 120 symptomatic patients ≥ 70 years of age at 14 centers in Australia and Europe. Patients had severe calcific aortic stenosis and were deemed to be at high or extreme risk of surgery based on assessment by the heart team.

The mean age was 84.4 ± 5.3 years, 57% (68 of 120) of patients were women, and the mean Society of Thoracic Surgeons score was 7.1 ± 4.6. The mean baseline aortic valve area was 0.7 ± 0.2 cm², and the mean transvalvular pressure gradient was 46.4 ± 15 mm Hg. All patients had successful implantation of a Lotus valve, and 1-year clinical follow-up was available for 99.2% (119 of 120) of the patients.

The mean 1-year transvalvular aortic pressure gradient was 12.6 ± 5.7 mm Hg, and the mean valve area was 1.7 ± 0.5 cm². A total of 88.6% patients had no or trivial paravalvular aortic regurgitation at 1 year by independent core lab adjudication, and 97.1% of patients were New York Heart Association functional class 1 or 2. At 1 year, the all-cause mortality rate was 10.9% (13 of 119 patients), the disabling stroke rate was 3.4% (4 of 119 patients), and the disabling bleeding rate was 5.9% (7 of 119 patients), with no repeat procedures for valve-related dysfunction. A total of 31.9% (38 of 119 patients) underwent new permanent pacemaker implantation at 1 year, reported the investigators in JACC: Cardiovascular Interventions.

Prof. Meredith, who serves as Principal Investigator of the REPRISE II, first presented the 1-year data in September 2014 at the 26th annual Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC.