One-Year Data Published From FORWARD Study of Medtronic's CoreValve Evolut R System
December 3, 2018—Ganesh Manoharan, MD, et al published 1-year outcomes from the international FORWARD study in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2018;11:2326–2334). The investigators concluded that the FORWARD study demonstrated good safety and efficacy profiles for the next generation of Medtronic's Evolut R repositionable, self-expanding transcatheter aortic valve replacement (TAVR) system at up to 1-year follow-up, with very low mortality and adverse events in routine clinical practice. At 30 days, the study reported low incidences of mortality, disabling stroke, and significant paravalvular leak following TAVR in routine clinical practice.
As summarized in JACC: Cardiovascular Interventions, the FORWARD investigators reported the following 1-year results:
- All-cause mortality rate = 8.9%
- Cardiovascular mortality rate = 6.9%
- Incidence of disabling stroke = 2.1%
- Patients implanted with a pacemaker = 19.7%
- Incidence of > mild paravalvular leak = 1.2%
FORWARD is a prospective, single-arm, multinational, multicenter, observational study. Between January and December 2016, 1,040 patients underwent attempted implant of the CoreValve Evolut R valve at 53 sites worldwide. An independent clinical events committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions. An independent echocardiographic core laboratory evaluated all echocardiograms. The mean patient age was 81.8 ± 6.2 years, and 64.8% were women. Patients had a mean Society of Thoracic Surgeons predicted risk of mortality score of 5.5% ± 4.5% and EuroSCORE II of 5.7% ± 5.0%, advised the investigators in JACC: Cardiovascular Interventions.