Setting a benchmark for resource utilization and quality of care in patients undergoing transcatheter aortic valve implantation in Europe-Rationale and design of the international BENCHMARK registry
Language English Country United States Media print-electronic
Document type Journal Article, Multicenter Study
Grant support
N/A
Edwards Lifesciences
PubMed
34499383
PubMed Central
PMC8495089
DOI
10.1002/clc.23711
Knihovny.cz E-resources
- Keywords
- TAVI, aortic stenosis, clinical practice, quality of care, registry, transcatheter aortic valve implantation,
- MeSH
- Aortic Valve surgery MeSH
- Aortic Valve Stenosis * surgery MeSH
- Benchmarking MeSH
- Time Factors MeSH
- Humans MeSH
- Prospective Studies MeSH
- Registries MeSH
- Retrospective Studies MeSH
- Transcatheter Aortic Valve Replacement * adverse effects MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Geographicals
- Europe MeSH
BACKGROUND: The use of transcatheter aortic valve implantation (TAVI) for treating aortic stenosis (AS) has increased exponentially in recent years. Despite the availability of clinical practice guidelines for the management of valvular heart disease, disparities in quality of care (QoC) for TAVI patients remain widespread across Europe. Tailored QoC measures will help to reduce resource utilization and improve patient outcomes without compromising patient safety. Using a clear set of QoC measures, the BENCHMARK registry aims to document the progress that can be achieved if such tailored QoC measures are implemented. METHODS: The BENCHMARK registry (BENCHMARK) is a non-interventional, multicenter registry in patients with severe symptomatic AS undergoing TAVI with a 1- and 12-months follow-up. BENCHMARK will be conducted at 30 centers across Europe and will enroll a total of 2400 consecutive TAVI patients. Patients suffering from severe symptomatic AS who undergo TAVI with a balloon-expandable transcatheter aortic valve will be included. The registry will comprise four phases: (1) a retrospective baseline evaluation phase; (2) an education phase; (3) an implementation phase; and (4) a prospective effect documentation phase (prospective phase). The registry's primary objectives are to reduce the length of hospital stay and accelerate the post-procedural patient recovery pathway, but without compromising safety. The study started in April 2021 and has an estimated completion date of May 2023. DISCUSSION: BENCHMARK will establish QoC measures to reduce resource utilization, intensive care unit bed occupancy, and overall length of hospitalization with uncompromised patient safety post-TAVI (ClinicalTrials.gov Identifier: NCT04579445).
Cardiology Department Frankfurt University Frankfurt Germany
Cardiology Department James Cook University Hospital Middlesbrough UK
Cardiology Department Royal Victoria Hospital Belfast UK
Department of Cardiology FHU CARNAVAL Normandie University UNIROUEN Rouen France
Department of Cardiology University of Bologna Bologna Italy
Department of Internal Medicine 3 Kiel Germany
Edwards Lifesciences Nyon Switzerland
Edwards Lifesciences Prague Czech Republic
German Center for Cardiovascular Research partner site Hamburg Kiel Lübeck Kiel Germany
Institute for Pharmacology and Preventive Medicine Cloppenburg Germany
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A streamlined pathway for transcatheter aortic valve implantation: the BENCHMARK study
ClinicalTrials.gov
NCT04579445