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

Joris F Ooms; Kristoff Cornelis; Harindra C Wijeysundera; Bert Vandeloo; Jan Van Der Heyden; Jan Kovac; David Wood; Albert Chan; Joanna Wykyrzykowska; Liesbeth Rosseel; Michael Cunnington; Frank van der Kley; Benno Rensing; Michiel Voskuil; David Hildick-Smith; Nicolas M Van Mieghem

doi:10.1007/s00392-024-02436-z

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

Clin Res Cardiol. 2024 Apr 15. doi: 10.1007/s00392-024-02436-z. Online ahead of print.

Authors

Joris F Ooms¹, Kristoff Cornelis², Harindra C Wijeysundera³, Bert Vandeloo⁴, Jan Van Der Heyden⁵, Jan Kovac⁶, David Wood⁷, Albert Chan⁸, Joanna Wykyrzykowska⁹, Liesbeth Rosseel¹⁰, Michael Cunnington¹¹, Frank van der Kley¹², Benno Rensing¹³, Michiel Voskuil¹⁴, David Hildick-Smith¹⁵, Nicolas M Van Mieghem¹⁶

Affiliations

¹ Department of Interventional Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, The Netherlands.
² AZ Maria Middelares, Ghent, Belgium.
³ Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
⁴ University Hospital Brussels, Brussels, Belgium.
⁵ Sint Jan Hospital, Brugge, Belgium.
⁶ University Hospitals Leicester NHS Trust, Leicester, UK.
⁷ Centre for Heart Valve Innovation, St. Paul's Hospital, University of British Columbia, Vancouver, BC, Canada.
⁸ Royal Columbian Hospital, New Westminster, BC, Canada.
⁹ University Medical Center Groningen, Groningen, The Netherlands.
¹⁰ ASZ Aalst, Aalst, Belgium.
¹¹ Leeds Teaching Hospitals NHS Trust, Leeds, UK.
¹² Leiden University Medical Center, Leiden, The Netherlands.
¹³ Sint Antonius Hospital, Nieuwegein, The Netherlands.
¹⁴ University Medical Center Utrecht, Utrecht, The Netherlands.
¹⁵ University Hospitals Brighton and Sussex NHS Trust, Brighton, UK.
¹⁶ Department of Interventional Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, The Netherlands. n.vanmieghem@erasmusmc.nl.

PMID: 38619575
DOI: 10.1007/s00392-024-02436-z

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.

Keywords: Early discharge; Self-expanding valve; TAVI.