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

NCT04579445 | Completed DMC

• 1 other identifier: BENCHMARK Registry
• Study Type: observational
• Target: 2,408
• Locations: 7 countries
• Sites: 28

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)

Conditions

Transcatheter Aortic Valve Implantation (TAVI)

Keywords

TAVI; Severe Aortic Stenosis; Optimizing TAVI patient outcomes; Optimizing TAVI care pathways

Outcome Measures

Primary Outcomes (10)

• Evaluation of differences in length of stay (LoS)

  LoS in days

  12 months

• Complication rate (AEs), TAVI related safety outcomes

  According to Valve Academic Research Consortium-2 consensus (VARC-2) criteria

  30 days

• Complication rate (AEs), TAVI related safety outcomes

  According to Valve Academic Research Consortium-2 consensus (VARC-2) criteria

  12 months

• Quality of Life assessment: Toronto Aortic Stenosis Quality of Life Questionnaire

  Assess the Quality of Life by using the Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ). Each question has a maximum score of 7 (response options from "not very much" to "very much"), giving the complete questionnaire a maximum total score of 112 with a higher score indicating improved Quality of Life.

  30 days

• Quality of Life assessment: Toronto Aortic Stenosis Quality of Life Questionnaire

  Assess the Quality of Life by using the Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ). Each question has a maximum score of 7 (response options from "not very much" to "very much"), giving the complete questionnaire a maximum total score of 112 with a higher score indicating improved Quality of Life.

  12 months

• Resource utilization - Early discharge information

  To determine the proportion of early discharges in sAS patients undergoing TAVI

  12 months

• Resource utilization - Working hours per patient

  To determine the working hours per patient

  12 months

• Resource utilization - Number of TAVI patients in each center

  To determine the number of patients undergoing TAVI (per center)

  12 months

• Physician and patient satisfaction

  Satisfaction score, scoring from 0 (extremely dissatisfied) to 40 (extremely satisfied)

  30 days

• Physician and patient satisfaction

  Satisfaction score, scoring from 0 (extremely dissatisfied) to 40 (extremely satisfied)

  12 months

Study Arms (1)

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)

Other: Education on tailored Quality Improvement measures

Interventions

Education on tailored Quality Improvement measures 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.

Also known as: Education on Quality of Care Improvement measures

TAVI patients

Eligibility Criteria

• Age: 18 Years - 115 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prospective phase: 50 severe Aortic stenosis patients undergoing transcatheter aortic valve implantation will be recruited within the prospective part per center. Retrospective phase: Retrospective documentation of 30 severe aortic stenosis pateints per center, who underwent a transcatheter aortic valve implantation will be performed.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut für Pharmakologie und Präventive Medizin: lead
• Edwards Lifesciences: collaborator

Study Sites (28)

St. Pölten University Hospital

Sankt Pölten, 3100, Austria

Location

KH Nord, Klinik Floridsdorf

Vienna, 1210, Austria

Location

IKEM Prague

Prague, 14021, Czechia

Location

Centre Hospitalier Universitaire de Besancon

Besançon, 25030, France

Location

Polyclinique Du Bois

Lille, 59000, France

Location

Infirmerie Protestante de Lyon

Lyon, 69641, France

Location

Hopital Saint Joseph

Marseille, 13008, France

Location

Centre Hospitalier Universitaire de Montpellier

Montpellier, 34295, France

Location

IMM (Institut Mutualiste Montsouris) Paris

Paris, 74014, France

Location

Pitie Salpetriere Hospital Paris

Paris, 75013, France

Location

CHU Rennes

Rennes, 35000, France

Location

CHRU Tours

Tours, 37000, France

Location

Herzzentrum Köln

Cologne, 50670, Germany

Location

University Medical Center Göttingen

Göttingen, 37075, Germany

Location

University Hospital Heidelberg

Heidelberg, 69120, Germany

Location

Saarland University Medical Center

Homburg, 66421, Germany

Location

CKMS Munich, Artemed Clinics

Munich, 81379, Germany

Location

Brüderkrankenhaus Trier

Trier, 54292, Germany

Location

L'Ospedale S.Giuseppe Moscati di Avellino

Avellino, 83100, Italy

Location

Careggi Hospital

Florence, 50134, Italy

Location

Centro Cardiologico, Monzino Hospital

Milan, 20141, Italy

Location

Azienda Ospedaliera Ordine Mauriziano di Torino

Torino, 10128, Italy

Location

Institutul de Urgenta pentru Boli Cardiolvasculaire

Bucharest, 022322, Romania

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Hospital Bellvitge

Barcelona, 08905, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Regional Universitario de Málaga

Málaga, 29001, Spain

Location

Hospital Universitari Son Espases

Palma de Mallorca, 07020, Spain

Location

Related Publications (3)

• 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.

  PMID: 34499383 BACKGROUND

• 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.

  PMID: 38554125 RESULT

• 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.

  PMID: 40261426 DERIVED

Related Links

• Registry webpage

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Derk Frank, Prof.

  UKSH Kiel

  PRINCIPAL INVESTIGATOR

• Gemma McCalmont

  James Cook Hospital, Middlesbrough, United Kingdom

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 8, 2020
• Study Start: May 3, 2021
• Primary Completion: April 30, 2023
• Study Completion: August 1, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9); RO (1); IT (4); DE (6); AU (2); CZ (1); ES (5)