Setting a Benchmark for Resource Utilization and Quality of Care in Patients Undergoing TAVI in Europe

NCT ID: NCT04579445

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2408 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-03
• Study Completion Date: 2024-08-01

Brief Summary

Non-interventional, multi-center, international registry in patients with severe aortic stenosis (sAS) undergoing transcatheter aortic valve implantation (TAVI). The BENCHMARK Registry aims to implement standardized, reproducible and scalable quality improvement measures, which will help to reduce resource requirements, intensive care unit bed occupancy and overall length of hospitalization with uncompromised patient safety.

The registry will consist of the following phases:

• Retrospective phase (purpose: capture the status quo of each site prior to any Quality of Care improvement measures): The TAVI of patients being eligible for retrospective documentation must have been performed prior to the site's enrollment into the BENCHMARK prospective phase (follow-up: 30 days, 12 months).
• Education phase: Each center will undergo an online BENCHMARK education. The contents of the education will be: Reflection on treatment pathways with the TAVI team, education on 8 defined Quality of Care improvement measures, followed by a center self-assessment (to self-assess the current alignment of hospital performance with the BENCHMARK Quality od Care measures).
• Implementation phase: After having self-assessed the current alignment of hospital performance with the following BENCHMARK Quality of care measures, each center will start to introduce the tailored Quality of Care improvement measures to their hospital routine within a time frame of 2 months.
• Prospective phase (purpose: to document the effects of defined quality of care improvement measure and to make sure patient safety is as least as good as in the retrospective phase. (8 months of recruitment, Follow-up: 30 days, 12 months)

Detailed Description

Transcatheter aortic valve implantation (TAVI) has become standard of care in patients suffering from severe, symptomatic aortic stenosis, irrespective of risk. However, despite the advances in valve technology and implantation techniques, there is still no consensus on how to effectively screen, manage and discharge patients undergoing such an intervention.

In an effort not to lose grounds because of an increasing inner-hospital competition for resources including intensive care unit (ICU) and general hospital beds, there is a need for a streamlined Quality of Care (QoC) pathway that delivers the procedure more efficient, but with at least the same patient safety. In this context, the recent FAST-TAVI (Feasibility And Safety of early discharge after Transfemoral TAVI) and North American Multidisciplinary, Multimodality, But Minimalist (3M) studies have shown that optimized risk assessment and patient management results in a more effective, as least as safe treatment pathway and a reduced length of stay (LoS).

The results gain importance especially in a situation where patients suffering from the coronavirus disease compete for hospital resources throughout Europe. Using a clear set of Quality of Care criteria, the BENCHMARK registry aims to document the progress that can be made if tailored Quality of Care improvement measures are initiated.

The hypothesis is that the implementation of standardized, reproducible and scalable Quality of Care improvement measures will help reducing resource requirements, intensive care unit bed occupancy and overall length of hospitalization with uncompromised patient safety.

There will be up to 30 centers participating across Europe (Germany, Austria, Italy, France, Spain, Czech Republic, Romania). Each center will enroll 80 patients (retrospective documentation of 30 patients, prospective enrollment of 50 patients), resulting in 2400 patients in total.

Conditions

Transcatheter Aortic Valve Implantation (TAVI)

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

TAVI patients

Consecutive, severe aortic stenosis patients undergoing transcatheter aortic valve implantation (TAVI) (there will be a retrospective part: documentation of 30 patients who underwent transfemoral TAVI; and a prospective part enrolling 50 patients undergoing transfemoral TAVI)

Education on tailored Quality Improvement measures

Intervention Type: OTHER

Centers will undergo an education on defined Quality of Care measures, with the aim to implement a standardized pathway which is reproducible, scalable and which will allow increased access. The implementation of these measures will help to reduce resource requirements, intensive care bed occupancy and overall length of hospital stay with uncompromised patient safety.

Interventions

Education on tailored Quality Improvement measures

Centers will undergo an education on defined Quality of Care measures, with the aim to implement a standardized pathway which is reproducible, scalable and which will allow increased access. The implementation of these measures will help to reduce resource requirements, intensive care bed occupancy and overall length of hospital stay with uncompromised patient safety.

Intervention Type: OTHER

Other Intervention Names

Education on Quality of Care Improvement measures

Eligibility Criteria

Inclusion Criteria

Retrospective phase:

• Consecutive, severe symptomatic aortic stenosis patients who underwent transcatheter aortic valve implantation with a balloon-expandable transcatheter aortic valve prior to the center education on BENCHMARK QoC (Quality of Care) improvement measure (prior to the first education call)).
• Patient is or was scheduled to undergo a 30 Day and 12 Months follow-up (30 Day and 12 Months follow-up: hospital visit or phone call)
• All patients irrespective of valve type or access route will be documented in an electronic Case Report Form (eCRF) based patient logbook.

Prospective phase:

• Consecutive patients with a diagnosis of severe symptomatic aortic stenosis admitted for TAVI with a balloon-expandable transcatheter heart valve after center education on BENCHMARK Quality of Care measures and after the center has passed the implementation phase.
• All patients irrespective of valve type or access route will be documented in an eCRF based patient logbook.

Exclusion Criteria

Retrospective phase:

• Patients with largely incomplete data with respect to the aims of the project.
• Patients without signed informed consent / data protection statement (according to requirements of local ethical committee).
• Pregnant women at the time of the TAVI.

Prospective phase:

• Patients without signed informed consent prior to the TAVI procedure (data protection statement included; ideally covered by hospital routine to enable consecutiveness).
• Pregnant women at the time of the TAVI.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 115 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edwards Lifesciences

INDUSTRY

Sponsor Role: collaborator

Institut für Pharmakologie und Präventive Medizin

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Derk Frank, Prof.

Role: PRINCIPAL_INVESTIGATOR

UKSH Kiel

Gemma McCalmont

Role: PRINCIPAL_INVESTIGATOR

James Cook Hospital, Middlesbrough, United Kingdom

Locations

St. Pölten University Hospital

Sankt Pölten, , Austria

KH Nord, Klinik Floridsdorf

Vienna, , Austria

IKEM Prague

Prague, , Czechia

Centre Hospitalier Universitaire de Besancon

Besançon, , France

Polyclinique Du Bois

Lille, , France

Infirmerie Protestante de Lyon

Lyon, , France

Hopital Saint Joseph

Marseille, , France

Centre Hospitalier Universitaire de Montpellier

Montpellier, , France

IMM (Institut Mutualiste Montsouris) Paris

Paris, , France

Pitie Salpetriere Hospital Paris

Paris, , France

CHU Rennes

Rennes, , France

CHRU Tours

Tours, , France

Herzzentrum Köln

Cologne, , Germany

University Medical Center Göttingen

Göttingen, , Germany

University Hospital Heidelberg

Heidelberg, , Germany

Saarland University Medical Center

Homburg, , Germany

CKMS Munich, Artemed Clinics

Munich, , Germany

Brüderkrankenhaus Trier

Trier, , Germany

L'Ospedale S.Giuseppe Moscati di Avellino

Avellino, , Italy

Careggi Hospital

Florence, , Italy

Centro Cardiologico, Monzino Hospital

Milan, , Italy

Azienda Ospedaliera Ordine Mauriziano di Torino

Torino, , Italy

Institutul de Urgenta pentru Boli Cardiolvasculaire

Bucharest, , Romania

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Hospital Bellvitge

Barcelona, , Spain

Hospital Clinico San Carlos

Madrid, , Spain

Hospital Regional Universitario de Málaga

Málaga, , Spain

Hospital Universitari Son Espases

Palma de Mallorca, , Spain

Countries

Austria; Czechia; France; Germany; Italy; Romania; Spain

References

McCalmont G, Durand E, Lauck S, Muir DF, Spence MS, Vasa-Nicotera M, Wood D, Saia F, Chatel N, Luske CM, Kurucova J, Bramlage P, Frank D. 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. Clin Cardiol. 2021 Oct;44(10):1344-1353. doi: 10.1002/clc.23711. Epub 2021 Sep 9.

Reference Type: BACKGROUND

PMID: 34499383 (View on PubMed)

Frank D, Durand E, Lauck S, Muir DF, Spence M, Vasa-Nicotera M, Wood D, Saia F, Urbano-Carrillo CA, Bouchayer D, Iliescu VA, Saint Etienne C, Leclercq F, Auffret V, Asmarats L, Di Mario C, Veugeois A, Maly J, Schober A, Nombela-Franco L, Werner N, Gomez-Hospital JA, Mascherbauer J, Musumeci G, Meneveau N, Meurice T, Mahfoud F, De Marco F, Seidler T, Leuschner F, Joly P, Collet JP, Vogt F, Di Lorenzo E, Kuhn E, Disdier VP, Hachaturyan V, Luske CM, Rakova R, Wesselink W, Kurucova J, Bramlage P, McCalmont G; BENCHMARK Investigator Group. A streamlined pathway for transcatheter aortic valve implantation: the BENCHMARK study. Eur Heart J. 2024 Jun 1;45(21):1904-1916. doi: 10.1093/eurheartj/ehae147.

Reference Type: RESULT

PMID: 38554125 (View on PubMed)

Saia F, Lauck S, Durand E, Muir DF, Spence M, Vasa-Nicotera M, Wood D, Urbano-Carrillo CA, Bouchayer D, Iliescu VA, Etienne CS, Leclercq F, Auffret V, Asmarats L, Di Mario C, Veugeois A, Maly J, Schober A, Nombela-Franco L, Werner N, Gomez-Hospital JA, Mascherbauer J, Musumeci G, Meneveau N, Meurice T, Mahfoud F, De Marco F, Seidler T, Leuschner F, Joly P, Collet JP, Vogt F, Di Lorenzo E, Kuhn E, Disdier VP, McCalmont G, Rakova R, Wesselink W, Kurucova J, Hachaturyan V, Luske CM, Bramlage P, Frank D; BENCHMARK Investigator Group. The implementation of a streamlined TAVI patient pathway across five European countries: BENCHMARK registry. Clin Res Cardiol. 2025 Apr 22. doi: 10.1007/s00392-025-02638-z. Online ahead of print.

Reference Type: DERIVED

PMID: 40261426 (View on PubMed)

Related Links

https://benchmark-registry.com

Registry webpage

Other Identifiers

BENCHMARK Registry

Identifier Type: -

Identifier Source: org_study_id