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

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^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

2 Citations (Scopus)

45 Downloads (Pure)

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 (Figure presented.).

Original language	English
Pages (from-to)	341–349
Number of pages	9
Journal	Clinical Research in Cardiology
Volume	114
Early online date	15-Apr-2024
DOIs	https://doi.org/10.1007/s00392-024-02436-z
Publication status	Published - 2025

Keywords

Early discharge
Self-expanding valve
TAVI

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Ooms, J. F., Cornelis, K., Wijeysundera, H. C., Vandeloo, B., Van Der Heyden, J., Kovac, J., Wood, D., Chan, A., Wykyrzykowska, J., Rosseel, L., Cunnington, M., van der Kley, F., Rensing, B., Voskuil, M., Hildick-Smith, D., & Van Mieghem, N. M. (2025). Safety and feasibility of early discharge after transcatheter aortic valve implantation with ACURATE Neo—the POLESTAR trial. Clinical Research in Cardiology, 114, 341–349. https://doi.org/10.1007/s00392-024-02436-z

@article{feafef3083d54b9790e73ff43df7066f,

title = "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 (Figure presented.).",

keywords = "Early discharge, Self-expanding valve, TAVI",

author = "Ooms, \{Joris F.\} and Kristoff Cornelis and Wijeysundera, \{Harindra C.\} and Bert Vandeloo and \{Van Der Heyden\}, Jan and Jan Kovac and David Wood and Albert Chan and Joanna Wykyrzykowska and Liesbeth Rosseel and Michael Cunnington and \{van der Kley\}, Frank and Benno Rensing and Michiel Voskuil and David Hildick-Smith and \{Van Mieghem\}, \{Nicolas M.\}",

note = "Publisher Copyright: {\textcopyright} The Author(s) 2024.",

year = "2025",

doi = "10.1007/s00392-024-02436-z",

language = "English",

volume = "114",

pages = "341–349",

journal = "Clinical Research in Cardiology",

issn = "1861-0684",

publisher = "SPRINGER HEIDELBERG",

}

Ooms, JF, Cornelis, K, Wijeysundera, HC, Vandeloo, B, Van Der Heyden, J, Kovac, J, Wood, D, Chan, A, Wykyrzykowska, J, Rosseel, L, Cunnington, M, van der Kley, F, Rensing, B, Voskuil, M, Hildick-Smith, D & Van Mieghem, NM 2025, 'Safety and feasibility of early discharge after transcatheter aortic valve implantation with ACURATE Neo—the POLESTAR trial', Clinical Research in Cardiology, vol. 114, pp. 341–349. https://doi.org/10.1007/s00392-024-02436-z

TY - JOUR

T1 - Safety and feasibility of early discharge after transcatheter aortic valve implantation with ACURATE Neo—the POLESTAR trial

AU - Ooms, Joris F.

AU - Cornelis, Kristoff

AU - Wijeysundera, Harindra C.

AU - Vandeloo, Bert

AU - Van Der Heyden, Jan

AU - Kovac, Jan

AU - Wood, David

AU - Chan, Albert

AU - Wykyrzykowska, Joanna

AU - Rosseel, Liesbeth

AU - Cunnington, Michael

AU - van der Kley, Frank

AU - Rensing, Benno

AU - Voskuil, Michiel

AU - Hildick-Smith, David

AU - Van Mieghem, Nicolas M.

PY - 2025

Y1 - 2025

N2 - 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 (Figure presented.).

AB - 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 (Figure presented.).

KW - Early discharge

KW - Self-expanding valve

KW - TAVI

UR - https://www.scopus.com/pages/publications/85190387339

U2 - 10.1007/s00392-024-02436-z

DO - 10.1007/s00392-024-02436-z

M3 - Article

AN - SCOPUS:85190387339

SN - 1861-0684

VL - 114

SP - 341

EP - 349

JO - Clinical Research in Cardiology

JF - Clinical Research in Cardiology

ER -

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

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