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

Abstract

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).

Keywords: TAVI; aortic stenosis; clinical practice; quality of care; registry; transcatheter aortic valve implantation.

FIGURE 1

Registry design (retrospective baseline evaluation phase, education phase, implementation phase and prospective effect documentation phase). The registry comprises four phases: (1) A retrospective baseline evaluation phase—this phase is the current status quo and includes documentation of treatment pathways and endpoints of “routine” patients. (2) An education phase, which phase provides education on the BENCHMARK quality of care measures and involves the self‐assessment of centers. (3) An implementation phase, which aims to improve routine hospital quality of care measures. (4) A prospective effect documentation phase—this phase documents the impact of implemented BENCHMARK quality of care measures on treatment pathways, outcomes, safety, and resource utilization. Note, each participating center should have a non‐physician TAVI coordinator in place. QoC, quality of care; TAVI, transcatheter aortic valve implantation

FIGURE 2

Education pathway (BENCHMARK QoC measures). Pathway stages 1–4: (1) center self‐assessment is performed prior to the online education seminar; (2) online center education on BENCHMARK QoC measures will be arranged by the education team (including the local steering committee member and/or the PI team and the registry management team). A minimum of 3 TAVI Team members, having been identified as a leadership team (TAVI coordinator and further staff members per site), will attend the seminar; (3) a post‐QoC education call to discuss the self‐assessment results and write a final action plan with the leadership team will be arranged 1 week after the education seminar; and (4) a follow‐up call will be arranged to review center progress on BENCHMARK QoC implementation. PI, principal investigator; QoC, quality of care