Objectives TAVR is a minimally invasive alternative to SAVR, offering a key treatment for high-risk patients with severe aortic stenosis, including those with advanced age or comorbidities. Its popularity has led to its use in lower volume institutions, where outcomes are comparable to higher volume centers. This study analyzes procedural volume and outcomes at our institution, compares them with the PARTNER III trial, and evaluates complications and patient selection criteria.

Design This was a retrospective descriptive study.

Setting This study was performed at a public, multi-institutional healthcare system featuring an acute care hospital with a Level I Adult Trauma and Burn Center.

Participants We obtained retrospective data on 37 patients who underwent TAVR in our hospital system in 2022. Data was collected on their outcomes, including mortality, readmission rates, and cardiovascular and cerebrovascular complications at 30 days and 1 year.

Interventions No interventions were performed on patients as this was a retrospective study.

Measurements and Main Results Patient outcomes were compared with PARTNER III trial results. There was no 30-day mortality (versus 1% in the PARTNER III trial), and a 1-year mortality rate of 2.7% as compared to 8.5% in the PARTNER III trial. At 30 days, 0% of patients were readmitted for valve-related issues.

Conclusions This study demonstrates that lower volume healthcare institutions can achieve outcomes comparable/similar to higher volume institutions in specialized procedures like TAVR, challenging the assumption that superior outcomes are tied to institutional size. Our findings highlight the importance of quality, teamwork, and individualized care in achieving excellent clinical outcomes, regardless of size.

Luis E. Tollinche (LET) is a grant recipient through Merck Investigator Studies Program (MISP) to fund clinical trials at MSKCC (NCT03808077). Luis E. Tollinche serves a consultancy and advisory role for Merck & Co. Pharmaceutical Company. Luis E. Tollinche serves a consultancy and advisory role for GE Healthcare. No other authors have any associated conflicts of interest to the best of our knowledge. No funding or financial support was received for this study.

This project was supported in part by the Clinical and Translational Science Collaborative (CTSC) of Cleveland which is funded by the National Institutes of Health (NIH), National Center for Advancing Translational Science (NCATS), Clinical and Translational Science Award (CTSA) grant, UL1TR002548. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

An exemption letter from the MetroHealth IRB was obtained with the study given the number: "STUDY00000533: TAVR Outcomes".

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Case Western Reserve University – MetroHealth Medical Center, Department of Anesthesiology and Perioperative Services, 2500 MetroHealth Drive Cleveland, OH 44109

Authors:

Faria Nisar – fnisarmetrohealth.org

Nicolas Mas D Alessandro – nmasdalessandrometrohealth.org

Alexander Estright – awestrightgmail.com

Samantha Pope – spope1metrohealth.org

Daniel Schiller – dschillermetrohealth.org

Luis Tollinche – ltollinchemetrohealth.org

Maninder Singh – msinghmetrohealth.org

Data for this project was procured the department and can be made available upon request.