Safety and feasibility of early discharge after transcatheter aortic valve implantation with ACURATE Neo—the POLESTAR trial

Abstract

Background Transcatheter aortic valve implantation (TAVI) serves a growing range of patients with severe aortic stenosis (AS). TAVI has evolved to a streamlined procedure minimizing length of hospital stay. Aims To evaluate the safety and efficacy of an early discharge (ED) strategy after TAVI. Methods We performed an international, multi-center, prospective observational single-arm study in AS patients undergoing TAVI with the ACURATE valve platform. Eligibility for ED was assessed prior to TAVI and based on prespecified selection criteria. Discharge ≤ 48 h was defined as ED. Primary Valve Academic Research Consortium (VARC)-3-defined 30-day safety and efficacy composite endpoints were landmarked at 48 h and compared between ED and non-ED groups. Results A total of 252 patients were included. The median age was 82 [25th–75th percentile, 78–85] years and the median Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score was 2.2% [25th–75th percentile, 1.6–3.3]. ED and non-ED were achieved in 173 (69%) and 79 (31%) patients respectively. Monitoring for conduction disturbances was the principal reason for non-ED (33%). Overall, at 30 days, all-cause mortality was 1%, new permanent pacemaker rate was 4%, and valve- or procedure-related rehospitalization was 4%. There was no difference in the primary safety and efficacy endpoint between the ED and non-ED cohorts (OR 0.84 [25th–75th percentile, 0.31–2.26], p = 0.73, and OR 0.97 [25th–75th percentile, 0.46–2.06], p = 0.94). The need for rehospitalization was similarly low for ED and non-ED groups. Conclusion Early discharge after TAVI with the ACURATE valve is safe and feasible in selected patients. Rhythm monitoring and extended clinical observation protracted hospital stay. Graphical Abstract Safety and feasibility of early discharge after transcatheter aortic valve implantation with ACURATE Neo, an international multi-center, prospective observational single-arm study. OR, odds ratio (95% confidence interval); VARC, Valve Academic Research Consortium