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

Gemma McCalmont, Eric Durand, Sandra Lauck, Douglas F Muir, Mark S Spence, Mariuca Vasa-Nicotera, David Wood, Francesco Saia, Nicolas Chatel, Claudia M Lüske, Jana Kurucova, Peter Bramlage, Derk Frank, Gemma McCalmont, Eric Durand, Sandra Lauck, Douglas F Muir, Mark S Spence, Mariuca Vasa-Nicotera, David Wood, Francesco Saia, Nicolas Chatel, Claudia M Lüske, Jana Kurucova, Peter Bramlage, Derk Frank

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.

Conflict of interest statement

G. M. C., E. D., S. L., D. M., M. S., M. V. N., D. W., F. S. and D. F. received Honoria for consultancy from Edwards Lifesciences and are part of the BENCHMARK Steering Committee. C. M. L. and P. B. are representatives of the sponsor IPPMed who has received funding from Edwards Lifesciences. N. C. and J. K. are employees of Edwards Lifesciences.

© 2021 The Authors. Clinical Cardiology published by Wiley Periodicals LLC.

Figures

FIGURE 1
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
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

References

    1. Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic‐valve replacement in high‐risk patients. N Engl J Med. 2011;364(23):2187‐2198.
    1. Singh K, Bhalla AS, Qutub MA, Carson K, Labinaz M. Systematic review and meta‐analysis to compare outcomes between intermediate‐ and high‐risk patients undergoing transcatheter aortic valve implantation. Eur Heart J Qual Care Clin Outcomes. 2017;3(4):289‐295.
    1. Kolte D, Vlahakes GJ, Palacios IF, et al. Transcatheter versus surgical aortic valve replacement in low‐risk patients. J Am Coll Cardiol. 2019;74(12):1532‐1540.
    1. Bekeredjian R, Szabo G, Balaban Ü, et al. Patients at low surgical risk as defined by the Society of Thoracic Surgeons Score undergoing isolated interventional or surgical aortic valve implantation: in‐hospital data and 1‐year results from the German Aortic Valve Registry (GARY). Eur Heart J. 2019;40(17):1323‐1330.
    1. Baumgartner H, Falk V, Bax JJ, et al. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017;38(36):2739‐2791.
    1. Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002;106(24):3006‐3008.
    1. Biasco L, Ferrari E, Pedrazzini G, et al. Access sites for TAVI: Patient selection criteria, technical aspects, and outcomes. Front Cardiovasc Med. 2018;5:88.
    1. Lauck SB, Wood DA, Baumbusch J, et al. Vancouver transcatheter aortic valve replacement clinical pathway: minimalist approach, standardized care, and discharge criteria to reduce length of stay. Circ Cardiovasc Qual Outcomes. 2016;9(3):312‐321.
    1. Lauck SB, Wood DA, Achtem L, et al. Risk stratification and clinical pathways to optimize length of stay after transcatheter aortic valve replacement. Can J Cardiol. 2014;30(12):1583‐1587.
    1. Puri R, Iung B, Cohen DJ, Rodés‐Cabau J. TAVI or No TAVI: Identifying patients unlikely to benefit from transcatheter aortic valve implantation. Eur Heart J. 2016;37(28):2217‐2225.
    1. Akodad M, Lefèvre T. TAVI: simplification is the ultimate sophistication. Front Cardiovasc Med. 2018;5:96.
    1. Barbanti M, Gulino S, Costa G, Tamburino C. Optimization and simplification of transcatheter aortic valve implantation therapy. Expert Rev Cardiovasc Ther. 2018;16(4):287‐296.
    1. Durand E, Borz B, Godin M, et al. Transfemoral aortic valve replacement with the Edwards SAPIEN and Edwards SAPIEN XT prosthesis using exclusively local anesthesia and fluoroscopic guidance: feasibility and 30‐day outcomes. JACC Cardiovasc Interv. 2012;5(5):461‐467.
    1. Serletis‐Bizios A, Durand E, Cellier G, et al. A prospective analysis of early discharge after transfemoral transcatheter aortic valve implantation. Am J Cardiol. 2016;118(6):866‐872.
    1. Saia F, Palmerini T, Marcelli C, et al. Routine minimalist transcatheter aortic valve implantation with local anesthesia only. J Cardiovasc Med (Hagerstown). 2020;21(10):805‐811.
    1. Spence MS, Baan J, Iacovelli F, et al. Prespecified risk criteria facilitate adequate discharge and long‐term outcomes after transfemoral transcatheter aortic valve implantation. J Am Heart Assoc. 2020;9(15):e016990.
    1. Wood DA, Lauck SB, Cairns JA, et al. The Vancouver 3M (multidisciplinary, multimodality, but minimalist) clinical pathway facilitates safe next‐day discharge home at low‐, medium‐, and high‐volume transfemoral transcatheter aortic valve replacement centers: the 3M TAVR study. JACC Cardiovasc Interv. 2019;12(5):459‐469.
    1. van Rosendael PJ, Delgado V, Bax JJ. Pacemaker implantation rate after transcatheter aortic valve implantation with early and new‐generation devices: a systematic review. Eur Heart J. 2018;39(21):2003‐2013.
    1. Lauck S, Forman J, Borregaard B, et al. Facilitating transcatheter aortic valve implantation in the era of COVID‐19: Recommendations for programmes. Eur J Cardiovasc Nurs. 2020;19(6):537‐544.
    1. Lauck S, Sathananthan J, Achtem L, Humphries K, Webb J, Wood D. Nurse‐led post‐procedure protocol to facilitate safe next‐day discharge home: Findings of the 3M TAVR study. Can J Cardiol. 2019;35(10):S204.
    1. Barbanti M, Baan J, Spence MS, et al. Feasibility and safety of early discharge after transfemoral transcatheter aortic valve implantation—rationale and design of the FAST‐TAVI registry. BMC Cardiovasc Disord. 2017;17(1):259.
    1. Barbanti M, van Mourik MS, Spence MS, et al. Optimising patient discharge management after transfemoral transcatheter aortic valve implantation: the multicentre European FAST‐TAVI trial. EuroIntervention. 2019;15(2):147‐154.
    1. Lauck SB, Arnold SV, Borregaard B, et al. Very early changes in quality of life after transcatheter aortic valve replacement: results from the 3M TAVR trial. Cardiovasc Revasc Med. 2020;21(12):1573‐1578.
    1. Sathananthan J, Webb JG, Lauck SB, et al. Impact of local anesthesia only versus procedural sedation using the vancouver clinical pathway for TAVR: insights from the 3M TAVR study. JACC Cardiovasc Interv. 2019;12(10):1000‐1001.
    1. Lauck SB, Sathananthan J, Park J, et al. Post‐procedure protocol to facilitate next‐day discharge: results of the multidisciplinary, multimodality but minimalist TAVR study. Catheter Cardiovasc Interv. 2020;96(2):450‐458.
    1. Wood DA, Sathananthan J. “Minimalist” transcatheter aortic valve implantation during the COVID‐19 pandemic: previously optional but now a necessity. EuroIntervention. 2020;16(6):e451‐e452.
    1. Kappetein AP, Head SJ, Genereux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium‐2 consensus document (VARC‐2). Eur J Cardiothorac Surg. 2012;42(5):S45‐S60.
    1. Asgar AW, Lauck S, Ko D, et al. Quality of care for transcatheter aortic valve implantation: development of canadian cardiovascular society quality indicators. Can J Cardiol. 2016;32(8):1038 e1‐4.
    1. De Ronde‐Tillmans M, Goudzwaard JA, El Faquir N, et al. TAVI Care and Cure, the Rotterdam multidisciplinary program for patients undergoing transcatheter aortic valve implantation: design and rationale. Int J Cardiol. 2020;302:36‐41.
    1. Frey N, Steeds RP, Serra A, et al. Quality of care assessment and improvement in aortic stenosis—rationale and design of a multicentre registry (IMPULSE). BMC Cardiovasc Disord. 2017;17(1):5.
    1. Rudolph TK, Messika‐Zeitoun D, Frey N, et al. Caseload management and outcome of patients with aortic stenosis in primary/secondary versus tertiary care settings‐design of the IMPULSE enhanced registry. Open Heart. 2019;6(2):e001019.

Source: PubMed

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

3
Iratkozz fel