Author + information
- Eberhard Grube1,
- Nicolas Van Mieghem2,
- Thomas Modine3,
- Sabine Bleiziffer4,
- Nikos Werner1 and
- Stephan Windecker5
The multicenter, prospective, single-arm, observational Evolut R FORWARD Study assessed 1038 patients with symptomatic aortic stenosis at increased surgical risk in a routine hospital setting. The 30-day mortality rate was 1.9% and disabling stroke was 1.8%. In anticipation of current trials evaluating TAVR in patients at lower surgical risk, we performed a post-hoc analysis in patients with an STS predicted risk of mortality <3.0%.
Patients were implanted with the self-expanding Evolut R transcatheter valve system (Medtronic, Minneapolis, MN) in routine practice at 53 centers on 4 continents after Heart Team assessment for eligibility. An independent Clinical Events Committee adjudicated safety endpoints to 30 days based on VARC-2 definitions. An independent echocardiographic core laboratory centrally analysed valve hemodynamics and the incidence of prosthetic valve regurgitation.
An STS <3% (mean 2.2±0.5%) was present in 257 patients. Baseline data included; mean age 77.9 ± 6.9 years, 53.7% women, 19.1% diabetes, 15.0% COPD, 7.8% prior CABG, 26.8% PCI, 10.6% MI, 26.3% AF. 98.0% had ≥ NYHA class II symptoms, 15.4% required assisted living and 28.6% were deemed frail. Conscious sedation was used in 52.1% of patients and iliofemoral access used in 99.2%. An Enveo R InLine sheath was used in 86.9% of patients. 1 valve was implanted in the proper anatomical position in all patients. At discharge, the mean AV gradient was 8.7±4.5 mmHg and EOA was 1.9±0.6 cm2. 30-Day outcomes are in the Table.
|No. of patients (Kaplan-Meier rates as %)||STS<3% (N=257)||STS≥3% (N=781)|
|All-cause mortality||5 (2.0)||15 (1.9)|
|Stroke||7 (2.8)||22 (2.8)|
|Disabling stroke||3 (1.2)||15 (1.9)|
|Major vascular complication||21 (7.8)||47 (6.0)|
|Stage 2 or 3 acute kidney injury||3 (1.2)||8 (1.0)|
|Life-threatening or disabling bleeding||16 (6.2)||18 (2.3)|
|Pacemaker implantation||45 (17.7)||135 (17.4)|
|NYHA classification I/II*||197 (87.2)||585 (88.4)|
*NYHA reported as no. (percentage of patients). AF; atrial fibrillation; CABG, coronary artery bypass grafting; COPD, chronic obstructive pulmonary disease; EOA, effective orifice area; LV, left ventricle; MI, myocardial infarction; NYHA, New York Heart Association; PCI, percutaneous coronary intervention; STS, Society of Thoracic Surgeons; TAVR, transcatheter aortic valve replacement.
Low-risk patients based on STS score had similar safety and efficacy results as previously shown for the entire FORWARD Study cohort.
STRUCTURAL: Valvular Disease: Aortic