Clinical trial NCT04579445: Setting a Benchmark for Resource Utilization and Quality of Care in Patients Undergoing TAVI in Europe
Official title: Setting a Benchmark for Resource Utilization and Quality of Care in Patients Undergoing Transcatheter Aortic Valve Implantation in Europe - The BENCHMARK Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transcatheter Aortic Valve Implantation (TAVI)
Keywords: TAVI
Severe Aortic Stenosis
Optimizing TAVI patient outcomes
Optimizing TAVI care pathways
Lead sponsor: Institut für Pharmakologie und Präventive Medizin
Sponsor class: NETWORK
Collaborators: name: Edwards Lifesciences
First posted: 2020-10-08
Enrollment: 2408
Sex: ALL
Minimum age (years): 18
Maximum age (years): 115
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Evaluation of differences in length of stay (LoS)
timeFrame: 12 months
measure: Complication rate (AEs), TAVI related safety outcomes
timeFrame: 30 days
measure: Complication rate (AEs), TAVI related safety outcomes
timeFrame: 12 months
measure: Quality of Life assessment: Toronto Aortic Stenosis Quality of Life Questionnaire
timeFrame: 30 days
measure: Quality of Life assessment: Toronto Aortic Stenosis Quality of Life Questionnaire
timeFrame: 12 months
measure: Resource utilization - Early discharge information
timeFrame: 12 months
measure: Resource utilization - Working hours per patient
timeFrame: 12 months
measure: Resource utilization - Number of TAVI patients in each center
timeFrame: 12 months
measure: Physician and patient satisfaction
timeFrame: 30 days
measure: Physician and patient satisfaction
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: St. Pölten
country: Austria
facility: St. Pölten University Hospital
city: Vienna
country: Austria
facility: KH Nord, Klinik Floridsdorf
city: Prague
country: Czechia
facility: IKEM Prague
city: Besançon
country: France
facility: Centre Hospitalier Universitaire de Besancon
city: Lille
country: France
facility: Polyclinique Du Bois
city: Lyon
country: France
facility: Infirmerie Protestante de Lyon
city: Marseille
country: France
facility: Hopital Saint Joseph
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire de Montpellier
city: Paris
country: France
facility: IMM (Institut Mutualiste Montsouris) Paris
city: Paris
country: France
facility: Pitie Salpetriere Hospital Paris
city: Rennes
country: France
facility: CHU Rennes
city: Tours
country: France
facility: CHRU Tours
city: Cologne
country: Germany
facility: Herzzentrum Köln
city: Göttingen
country: Germany
facility: University Medical Center Göttingen
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
city: Homburg
country: Germany
facility: Saarland University Medical Center
city: Munich
country: Germany
facility: CKMS Munich, Artemed Clinics
city: Trier
country: Germany
facility: Brüderkrankenhaus Trier
city: Avellino
country: Italy
facility: L'Ospedale S.Giuseppe Moscati di Avellino
city: Florence
country: Italy
facility: Careggi Hospital
city: Milan
country: Italy
facility: Centro Cardiologico, Monzino Hospital
city: Torino
country: Italy
facility: Azienda Ospedaliera Ordine Mauriziano di Torino
city: Bucharest
country: Romania
facility: Institutul de Urgenta pentru Boli Cardiolvasculaire
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Bellvitge
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Palma De Mallorca
country: Spain
facility: Hospital Universitari Son Espases
Study officials:
affiliation: UKSH Kiel
name: Derk Frank, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: James Cook Hospital, Middlesbrough, United Kingdom
name: Gemma McCalmont
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.