Rationale and design of the Project to look for early discharge in patients undergoing TAVR with ACURATE (POLESTAR Trial)

Joris F. Ooms; Kristoff Cornelis; Pieter R. Stella; Benno J. Rensing; Jan van der Heyden; Albert W. Chan; Joanna J. Wykrzykowska; Liesbeth Rosseel; Bert Vandeloo; Mattie J. Lenzen; Michael S. Cunnington; David Hildick-Smith; Harindra C. Wijeysundera; Nicolas M. van Mieghem

doi:https://doi.org/10.1016/j.carrev.2022.06.009

Rationale and design of the Project to look for early discharge in patients undergoing TAVR with ACURATE (POLESTAR Trial)

Joris F. Ooms, Kristoff Cornelis, Pieter R. Stella, Benno J. Rensing, Jan van der Heyden, Albert W. Chan, Joanna J. Wykrzykowska, Liesbeth Rosseel, Bert Vandeloo, Mattie J. Lenzen, Michael S. Cunnington, David Hildick-Smith, Harindra C. Wijeysundera, Nicolas M. van Mieghem

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

Abstract

Background: Transcatheter aortic valve replacement (TAVR) is now an established treatment strategy for elderly patients with symptomatic aortic stenosis (AS) across the entire operative risk spectrum. Streamlined TAVR protocols along with reduced procedure time and expedited ambulation promote early hospital discharge. Selection of patients suitable for safe early discharge after TAVR might improve healthcare efficiency. Study design: The POLESTAR trial is an international, multi-center, prospective, observational study which aims to evaluate the safety of early discharge in selected patients who undergo TAVR with the supra-annular functioning self-expanding ACURATE Neo transcatheter heart valve (THV). A total of 250 patients will be included based on a set of baseline criteria indicating potential early discharge (within 48 h post-TAVR). Primary study endpoints include Valve Academic Research Consortium (VARC)-3 defined safety at 30 days and VARC-3 defined efficacy at 30 days and 1 year. Endpoints will be compared between early discharge and non-early discharge cohorts with a distinct landmark analysis at 48 h post-TAVR. Secondary endpoints include quality of life assessed using EQ5D-5L and Kansas City Cardiomyopathy Questionnaire (KCCQ) questionnaires and resource costs compared between discharge groups. The POLESTAR trial prospectively evaluates safety and feasibility of an early discharge protocol for TAVR using the ACURATE Neo THV.

Original language	English
Pages (from-to)	71-77
Number of pages	7
Journal	Cardiovascular Revascularization Medicine
Volume	44
Early online date	2022
DOIs	https://doi.org/10.1016/j.carrev.2022.06.009
Publication status	Published - Nov 2022
Externally published	Yes

Keywords

Aortic stenosis
Early discharge
TAVR

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Ooms, J. F., Cornelis, K., Stella, P. R., Rensing, B. J., van der Heyden, J., Chan, A. W., Wykrzykowska, J. J., Rosseel, L., Vandeloo, B., Lenzen, M. J., Cunnington, M. S., Hildick-Smith, D., Wijeysundera, H. C., & van Mieghem, N. M. (2022). Rationale and design of the Project to look for early discharge in patients undergoing TAVR with ACURATE (POLESTAR Trial). Cardiovascular Revascularization Medicine, 44, 71-77. https://doi.org/10.1016/j.carrev.2022.06.009

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title = "Rationale and design of the Project to look for early discharge in patients undergoing TAVR with ACURATE (POLESTAR Trial)",

abstract = "Background: Transcatheter aortic valve replacement (TAVR) is now an established treatment strategy for elderly patients with symptomatic aortic stenosis (AS) across the entire operative risk spectrum. Streamlined TAVR protocols along with reduced procedure time and expedited ambulation promote early hospital discharge. Selection of patients suitable for safe early discharge after TAVR might improve healthcare efficiency. Study design: The POLESTAR trial is an international, multi-center, prospective, observational study which aims to evaluate the safety of early discharge in selected patients who undergo TAVR with the supra-annular functioning self-expanding ACURATE Neo transcatheter heart valve (THV). A total of 250 patients will be included based on a set of baseline criteria indicating potential early discharge (within 48 h post-TAVR). Primary study endpoints include Valve Academic Research Consortium (VARC)-3 defined safety at 30 days and VARC-3 defined efficacy at 30 days and 1 year. Endpoints will be compared between early discharge and non-early discharge cohorts with a distinct landmark analysis at 48 h post-TAVR. Secondary endpoints include quality of life assessed using EQ5D-5L and Kansas City Cardiomyopathy Questionnaire (KCCQ) questionnaires and resource costs compared between discharge groups. The POLESTAR trial prospectively evaluates safety and feasibility of an early discharge protocol for TAVR using the ACURATE Neo THV.",

keywords = "Aortic stenosis, Early discharge, TAVR",

author = "Ooms, {Joris F.} and Kristoff Cornelis and Stella, {Pieter R.} and Rensing, {Benno J.} and {van der Heyden}, Jan and Chan, {Albert W.} and Wykrzykowska, {Joanna J.} and Liesbeth Rosseel and Bert Vandeloo and Lenzen, {Mattie J.} and Cunnington, {Michael S.} and David Hildick-Smith and Wijeysundera, {Harindra C.} and {van Mieghem}, {Nicolas M.}",

note = "Publisher Copyright: {\textcopyright} 2022 The Authors",

year = "2022",

month = nov,

doi = "https://doi.org/10.1016/j.carrev.2022.06.009",

language = "English",

volume = "44",

pages = "71--77",

journal = "Cardiovascular Revascularization Medicine",

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Ooms, JF, Cornelis, K, Stella, PR, Rensing, BJ, van der Heyden, J, Chan, AW, Wykrzykowska, JJ, Rosseel, L, Vandeloo, B, Lenzen, MJ, Cunnington, MS, Hildick-Smith, D, Wijeysundera, HC & van Mieghem, NM 2022, 'Rationale and design of the Project to look for early discharge in patients undergoing TAVR with ACURATE (POLESTAR Trial)', Cardiovascular Revascularization Medicine, vol. 44, pp. 71-77. https://doi.org/10.1016/j.carrev.2022.06.009

TY - JOUR

T1 - Rationale and design of the Project to look for early discharge in patients undergoing TAVR with ACURATE (POLESTAR Trial)

AU - Ooms, Joris F.

AU - Cornelis, Kristoff

AU - Stella, Pieter R.

AU - Rensing, Benno J.

AU - van der Heyden, Jan

AU - Chan, Albert W.

AU - Wykrzykowska, Joanna J.

AU - Rosseel, Liesbeth

AU - Vandeloo, Bert

AU - Lenzen, Mattie J.

AU - Cunnington, Michael S.

AU - Hildick-Smith, David

AU - Wijeysundera, Harindra C.

AU - van Mieghem, Nicolas M.

PY - 2022/11

Y1 - 2022/11

N2 - Background: Transcatheter aortic valve replacement (TAVR) is now an established treatment strategy for elderly patients with symptomatic aortic stenosis (AS) across the entire operative risk spectrum. Streamlined TAVR protocols along with reduced procedure time and expedited ambulation promote early hospital discharge. Selection of patients suitable for safe early discharge after TAVR might improve healthcare efficiency. Study design: The POLESTAR trial is an international, multi-center, prospective, observational study which aims to evaluate the safety of early discharge in selected patients who undergo TAVR with the supra-annular functioning self-expanding ACURATE Neo transcatheter heart valve (THV). A total of 250 patients will be included based on a set of baseline criteria indicating potential early discharge (within 48 h post-TAVR). Primary study endpoints include Valve Academic Research Consortium (VARC)-3 defined safety at 30 days and VARC-3 defined efficacy at 30 days and 1 year. Endpoints will be compared between early discharge and non-early discharge cohorts with a distinct landmark analysis at 48 h post-TAVR. Secondary endpoints include quality of life assessed using EQ5D-5L and Kansas City Cardiomyopathy Questionnaire (KCCQ) questionnaires and resource costs compared between discharge groups. The POLESTAR trial prospectively evaluates safety and feasibility of an early discharge protocol for TAVR using the ACURATE Neo THV.

AB - Background: Transcatheter aortic valve replacement (TAVR) is now an established treatment strategy for elderly patients with symptomatic aortic stenosis (AS) across the entire operative risk spectrum. Streamlined TAVR protocols along with reduced procedure time and expedited ambulation promote early hospital discharge. Selection of patients suitable for safe early discharge after TAVR might improve healthcare efficiency. Study design: The POLESTAR trial is an international, multi-center, prospective, observational study which aims to evaluate the safety of early discharge in selected patients who undergo TAVR with the supra-annular functioning self-expanding ACURATE Neo transcatheter heart valve (THV). A total of 250 patients will be included based on a set of baseline criteria indicating potential early discharge (within 48 h post-TAVR). Primary study endpoints include Valve Academic Research Consortium (VARC)-3 defined safety at 30 days and VARC-3 defined efficacy at 30 days and 1 year. Endpoints will be compared between early discharge and non-early discharge cohorts with a distinct landmark analysis at 48 h post-TAVR. Secondary endpoints include quality of life assessed using EQ5D-5L and Kansas City Cardiomyopathy Questionnaire (KCCQ) questionnaires and resource costs compared between discharge groups. The POLESTAR trial prospectively evaluates safety and feasibility of an early discharge protocol for TAVR using the ACURATE Neo THV.

KW - Aortic stenosis

KW - Early discharge

KW - TAVR

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U2 - https://doi.org/10.1016/j.carrev.2022.06.009

DO - https://doi.org/10.1016/j.carrev.2022.06.009

M3 - Article

C2 - 35739011

SN - 1553-8389

VL - 44

SP - 71

EP - 77

JO - Cardiovascular Revascularization Medicine

JF - Cardiovascular Revascularization Medicine

ER -

Rationale and design of the Project to look for early discharge in patients undergoing TAVR with ACURATE (POLESTAR Trial)

Abstract

Keywords

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