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).


| INTRODUCTION
Transcatheter aortic valve implantation (TAVI) has emerged as standard of care for patients suffering from severe, symptomatic aortic stenosis (AS), irrespective of the level of surgical risk. [1][2][3][4][5] Since its introduction almost two decades ago, 6 an evolving understanding of patient and prosthesis selection, increased peri-procedural expertise, and advances in valve technology have contributed to improved outcomes and patient access to TAVI. 7 As a consequence of TAVI indications expanding to younger and lower-risk patients, there has been a clear shift in interest toward reducing healthcare resource utilization, and identifying factors likely to predict potential futility of the procedure 5,[8][9][10] For example, a minimalist approach to help reduce procedure waiting times, resource use and costs, length of hospital stay, and staff workload. 11,12 Local programs that incorporate procedural algorithms to simplify the TAVI care pathway have been developed by many centers. 8,[12][13][14][15] However, the quality of care (QoC) for TAVI patients across Europe remains highly variable, particularly in terms of effective screening and patient discharge/follow-up management. 16,17 A unified strategy is warranted to ensure that all patients receive consistent pre-, peri-and post-TAVI care and optimized outcomes. 18 To achieve standardized QoC, some centers of excellence have introduced a dedicated coordinator or TAVI nurse to ensure a streamlined care pathway for all patients. 19,20 The TAVI coordinator/nurse helps to manage the procedural program for individual patients while maintaining seamless communication with the Heart Team throughout the patient care journey, making the process more streamlined. 19 One of the TAVI coordinator's roles is to ensure that all relevant screening results (e.g., echocardiography, computed tomography [CT] imaging scans, coronary angiogram, blood tests, etc.) are distributed to all members of the Heart Team promptly to inform patient discussion and to prevent delays in Heart Team recommendations. 5 Lauck et al. 19 endorse this coordinated, streamlined approach to reduce the length of hospital stays and appropriately distribute healthcare resources. The recent multicenter European Feasibility and Safety of Early Discharge After Transfemoral TAVI (FAST-TAVI) 21,22 and Vancouver 3M (multidisciplinary, multimodality, but minimalist) transfemoral transcatheter aortic valve replacement (TAVR) studies 17,[23][24][25] have shown that adhering to a minimalist strategy, with optimized criteria for risk assessment and patient discharge management, results in a more efficient care pathway, thus reducing the length of hospital stay and enabling a safe and timely discharge for patients. Furthermore, these studies have gained added importance recently due to the unprecedented stress on healthcare resources caused by the Coronavirus disease (Covid-19) pandemic. 19,26 A consistent pre-, peri-, and post-procedural management strategy is essential to improve QoC for TAVI patients. Implementing a tailored set of QoC measures as a benchmark for best practice will further reduce resource utilization, intensive care unit (ICU) bed occupancy, and overall length of hospitalization without compromising patient safety post-TAVI. The BENCHMARK registry aims to document the progress that can be achieved in clinical practice if consistent QoC measures are initiated in TAVI centers and the rationale for this study is supported by the FAST TAVI, the French FAST TAVI 1 and Vancouver 3M TAVR studies. 13 from the Declaration of Helsinki. All participants will provide written informed consent before enrolling in the registry. The protocol and patient informed consent forms will be approved by the local Institutional Review Board (IRB)/Independent Ethics Committee (IEC) at each center prior to initiation of the registry.

| Study design
The BENCHMARK registry will document the effect of introducing tailored BENCHMARK QoC measures (Table 1) into TAVI centers using four distinct phases: Retrospective baseline evaluation phase, education phase, implementation phase, and prospective effect documentation phase ( Figure 1). For the baseline evaluation phase (retrospective phase), each center will retrospectively document 30 consecutive patients (N = 900) undergoing transfemoral TAVI with a balloon expandable transcatheter aortic valve before introducing the BENCHMARK QoC measures. The TAVI procedure and patient discharge within this phase must have been performed prior to the first educational phone call. For each patient, follow-up data after 1 and 12 months will be recorded. In the education phase, each center will identify a defined leadership team (i.e., multidisciplinary heart team) to undergo online education on the BENCHMARK QoC measures and best practices. A detailed description of the education phase is shown in Figure 2. During the Implementation Phase, consisting of a 2-month time window, each center will introduce the tailored QoC measures into their hospital routine. Follow-up calls will be arranged between the BENCHMARK education team and each center every 2 weeks to offer assistance with regard to implementation progress. Finally, each center will prospectively enroll 50 consecutive patients (N = 1500) undergoing TAVI after completing the education and implementation phases. This prospective phase is estimated to be 20 months duration overall, with up to 8 months for patient recruitment and 12 months follow-up for the last patient included.

| Patients
A total number of 2400 patients aged ≥18 years old with symptomatic AS who undergo TF TAVI with a balloon-expandable transcatheter aortic valve will be included. Approximately 900 consecutive patients will be documented in the retrospective baseline evaluation phase (30 per center) and 1500 patients in the prospective phase (50 per center). The sample size estimate is based on the ability to discriminate any changes in outcomes between the retrospective baseline evaluation phase and the prospective effect documentation phase.
All patients irrespective of transcatheter valve type or access route, will be documented in an electronic case report form (eCRF) based patient logbook. A defined core data set will be collected for all patients (mortality, stroke, time of discharge/length of hospital stay, readmission).

| Inclusion and exclusion criteria
In the baseline evaluation phase, inclusion criteria included patients of at least 18 years of age, consecutive patients with T A B L E 1 BENCHMARK QoC measures BENCHMARK QoC measures Implementation description

Education of patient and family
The patient, and if the patient is not independent, at least one family member or carer is involved in the patient-education, and discharge provision is discussed with them prior to the procedure.

Education and alignment of the internal team (medical and paramedical)
At least one joint meeting per year is organized to educate all staff involved in the diagnostics, post-procedural care and intervention of patients with severe AS.
3. Determination of an anticipated discharge date at admission based on pre-procedural risk stratification and scheduling of post-procedural diagnostics accordingly Anticipated discharge date is determined at admission, and post-procedural diagnostics are scheduled accordingly.
4. Echo-or angiographic check at the end of procedure is performed to confirm proper closing of access site and proper management of all complications is done immediately Echo-or angiographic check is performed in the hybrid room, and even minor vascular complications are treated immediately.

Early mobilization of the patient
Mobilization of the patient with the help of a nurse is done 4-6 h after the intervention in absence of complications.
6. Using a decision tree to determine the need for new pacemaker implantation without increasing hospital stay Detailed decision tree with required diagnostic work-up is in place and has been followed for each patient.

Daily visit to patient by implanter and interaction with rest of the team
At least one daily visit of the patient is being done by a TAVI implanter (team) during hospitalization from the day before the intervention up to patient discharge.

Criteria based discharge
Early discharge decision protocol (or checklist) is in place and is followed for each patient.  (Table 2).
Patients undergoing valve-in-valve procedures or repeat TAVI will not be included in the registry.

| Data collection
Clinical outcome data collected will be based on the center's standard of care for TAVI. Data will be collected according to the timetable set out in Table 3, and include physical assessments, medical history and symptoms, diagnostics, electrocardiography (ECG), echocardiography (Echo), hospitalization and procedural duration, safety parameters, QoL measures, satisfaction surveys, as well as resource utilization parameters. Data will be captured in an eCRF by either a study nurse or physician, and the registry sponsor will check all data for plausibility and completeness.

| Registry objectives
The primary objective of the BENCHMARK registry is to document the effect of introducing tailored BENCHMARK QoC measures into TAVI centers to (1) decrease length of hospital stay; and (2) reduce the need for ICU capacity. Secondary objectives will be to streamline diagnostics, minimize staff workload allowing timely delegation of  Table 4.

| Statistical analysis
Statistical analysis will be performed for the total registry population as well as for defined subgroups if applicable. Continuous variables will be presented as mean ± SD or median with interquartile range, and categorical variables (e.g., gender) will be reported as frequencies

| DISCUSSION
The BENCHMARK registry has been designed to document the effect of introducing tailored BENCHMARK QoC measures into TAVI centers. Analysis of the data gathered may provide additional insights to F I G U R E 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 further refine and improve QoC measures and best practices for the effective management of patients with severe AS. The knowledge acquired from the BENCHMARK registry dataset will help to standardize care pathways and treatment outcomes for TAVI patients across Europe.

| Studies that support the BENCHMARK registry
Results from the European FAST-TAVI study support the BENCH-MARK registry and show that the use of a pre-defined set of QoC measures can lead to reduced use of medical resources, improved QoL, and optimized patient outcomes. 21,22 FAST-TAVI is a real-world, observational, prospective trial designed to assess early discharge feasibility and safety after transfemoral TAVI (TF-TAVI). 22 Patients (N = 502) with severe AS scheduled to undergo TF-TAVI with a balloon-expandable transcatheter heart valve were enrolled from ten sites in Italy, the Netherlands, and the United Kingdom. 22 FAST-TAVI provides evidence that close monitoring, early mobilization and accelerated reconditioning, and discharge planning should be included in the TAVI program since these are important aspects of QoC. 19  The BENCHMARK registry will further support the findings from these studies, and determine potential cost savings and improvements in QoC that can be adopted as the new benchmark.

| Potential limitations
The BENCHMARK registry will be conducted in multiple centers in seven European countries, which increases the applicability of findings but might limit the generalizability of the results across wider territories. Furthermore, not all patients having TAVI will be eligible for this registry. It is important to consider that inter-and intra-country variation in healthcare systems and resources may have an unintended impact on the registry dataset. Due to the lack of central adjudication of safety events, the assessment of endpoints may be inconsistent between centers. This registry is not randomized and, as a result, there is the potential for confounding and bias in the analysis with limited ability for adjustment. In addition, we expect that length of stay will also decline in hospitals in general, but probably to a lesser extent. However, it is hoped that implementing standardized BENCHMARK QoC measures will minimize any bias owing to possible differences in healthcare systems.

| CONCLUSIONS
Practice and patient outcomes in TAVI vary widely across TAVI centers in Europe and internationally, partly because QoC benchmarks for patient selection and discharge remains unclear. Several real-world studies have already shown that streamlining care pathways, for example, appropriate early discharge home, can reduce resource utilization and improve patients' outcomes. 13,14,17 The BENCHMARK registry will enable the next steps toward standardizing benchmark QoC measures in TAVI centers across Europe and worldwide.