Rationale and Design of the Project to Look for Early Discharge in Patients Undergoing TAVR With ACURATE (POLESTAR Trial)

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Symptomatic severe aortic stenosis undergoing transfemoral TAVR (n=250). Intervention: Early discharge protocol (within 48 hours post-TAVR) after transfemoral TAVR with ACURATE Neo THV vs. Non-early discharge cohort (>48 hours post-TAVR). Primary outcome: VARC-3 defined safety at 30 days and VARC-3 defined efficacy at 30 days and 1 year, alongside the proportion of patients discharged home within 48 hours.

Q: What does this research mean for the field?

The POLESTAR trial establishes an international prospective study design to evaluate the safety, feasibility, and clinical outcomes of early discharge within 48 hours in selected patients undergoing TAVR with the ACURATE Neo transcatheter heart valve. Novelty: ClaimNovelty.METHODOLOGICAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

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 Lenzen; Michael Cunnington; David Hildick‐Smith; Harindra C. Wijeysundera; Nicolas M. Van Mieghem

doi:10.1016/j.carrev.2022.06.009

June 15, 2022Cardiovascular revascularization medicineOpen Access

Rationale and Design of the Project to Look for Early Discharge in Patients Undergoing TAVR With ACURATE (POLESTAR Trial)

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Key result

POLESTAR evaluates the safety and feasibility of discharge within 48 hours after ACURATE Neo TAVR.

n=250

Why the study?

Streamlined TAVR protocols promote early hospital discharge, and selecting patients suitable for safe early discharge might improve healthcare efficiency.

Is a predetermined early home discharge protocol within 48 hours safe and feasible in selected patients undergoing transfemoral TAVR with the ACURATE Neo transcatheter heart valve?

Study Design

Type

Observational (n=250)

Multicenter

Yes

Structured PICO

Is a predetermined early home discharge protocol within 48 hours safe and feasible in selected patients undergoing transfemoral TAVR with the ACURATE Neo transcatheter heart valve?

P

Population

250 adults aged ≥18 years with symptomatic severe aortic stenosis undergoing transfemoral TAVR with the ACURATE Neo platform and eligible for early discharge within 48 hours, followed for 1 year.

E

Exposure

Predetermined early hospital discharge strategy (to the patient's home environment within 48 hours post-procedure) following streamlined transfemoral TAVR with the self-expanding supra-annular ACURATE Neo / Neo2 transcatheter heart valve

C

Comparator

Non-early discharge cohort (patients discharged >48 hours post-TAVR), compared via landmark analysis set at 48 hours post-TAVR

O

Outcome

Proportion of patients discharged to home within 48 hours after TAVR; VARC-3 defined composite safety endpoint at 30 days (all-cause death, any stroke, VARC type 2-4 bleeding, acute kidney injury stage 3-4, major vascular/access-related/cardiac structural complication, moderate or severe aortic regurgitation, new permanent pacemaker implantation, or THV-related surgery/intervention); and VARC-3 defined composite efficacy endpoint at 30 days and 1 year (all-cause death, all stroke, procedure- or valve-related rehospitalization, or KCCQ Overall Summary Score <45 or decline from baseline >10 points)composite

This study protocol establishes the design of the first prospective multicenter evaluation of a 48-hour early home discharge pathway specifically for patients undergoing transfemoral TAVR with the self-expanding ACURATE Neo valve.

Limitations

Observational single-arm study design without formal randomization
Feasibility study with no formal power calculation regarding clinical endpoints
COVID-19 pandemic and delayed national regulatory processes prolonged the study enrollment timeline
Observational non-randomized study design
COVID-19 pandemic and regulatory delays slowed study enrollment and restricted on-site follow-up visits and echocardiograms

Implication

48-hour TAVR discharge lacks supporting data; leaves open safety and feasibility with ACURATE Neo in selected patients.

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. SUMMARY: The POLESTAR trial prospectively evaluates safety and feasibility of an early discharge protocol for TAVR using the ACURATE Neo THV.

Discussion

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Cite This Study

Ooms et al. (2022) conducted an observational in Symptomatic severe aortic stenosis undergoing transfemoral TAVR (n=250). Early discharge protocol (within 48 hours post-TAVR) after transfemoral TAVR with ACURATE Neo THV vs. Non-early discharge cohort (>48 hours post-TAVR) was evaluated on VARC-3 defined safety at 30 days and VARC-3 defined efficacy at 30 days and 1 year, alongside the proportion of patients discharged home within 48 hours. The POLESTAR trial is an ongoing prospective study of 250 patients evaluating the safety and feasibility of discharge within 48 hours after ACURATE Neo TAVR, with no results reported yet.

synapsesocial.com/papers/6a777b34cb17b32ad6bd72e8 https://doi.org/10.1016/j.carrev.2022.06.009

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Rationale and Design of the Project to Look for Early Discharge in Patients Undergoing TAVR With ACURATE (POLESTAR Trial)

Study Design

Structured PICO

Limitations

Implication

Abstract

Discussion

Cite This Study

Rationale and Design of the Project to Look for Early Discharge in Patients Undergoing TAVR With ACURATE (POLESTAR Trial)

Study Design

Structured PICO

Limitations

Implication

Abstract

Discussion

Cite This Study

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