Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.

Official title

Title Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.

Overview

The issue of valve durability has become one of the most important aspects in the TAVR field in recent years since transcatheter aortic valve replacement has been progressively applied to younger patients with a low co-morbidity burden. The SAPIEN 3 Ultra RESILIA valve represents the last generation of the SAPIEN valve system and includes several important iterations (newer leaflet calcium-blocking technology targeting calcium-attracting free aldehydes, dry tissue storage, newer skirt textile design) that should translate into a favorable impact on valve durability at mid- to long- term follow-up

Detailed description

Prospective observational registry including patients with severe aortic stenosis undergoing TAVR with the SAPIEN 3 Ultra RESILIA valve. All patients who will survive the procedure will undergo a clinical and echocardiographic follow-up at 1-3 months (± 15 days), at 1-year (±30 days), 3-5 year (±30 days), 6-8 year (±30 days) and 9-10 year (±30 days) after valve implantation. Transthoracic echocardiography (TTE) exams (baseline, 1-3-month, 1 year, 3-5 years, 6-8 years, and 9-10 years post-procedure) will be evaluated in a Centralized Echocardiographic Core Lab at the Quebec Heart and Lung Institute. The measurements obtained in the Core Lab regarding transvalvular gradient, EOA, PPM and PVL at 1-3 months will determine the primary outcome of the study.

Interventions

• Procedure SAPIEN 3 Ultra RESILIA Valve
  Patients with severe aortic stenosis undergoing transarterial TAVR with the SAPIEN 3 Ultra RESILIA valve.

Primary outcome measures

• Transvalvular gradient [Time frame: 1-3 months]
• Effective orifice area (EOA) [Time frame: 1-3 months]
• Prosthesis-patient mismatch [Time frame: 1-3 months]
• Paravalvular leaks [Time frame: 1-3 months]

Secondary outcome measures (10)

• Transvalvular gradient [Time frame: 1-, 3-5-, 6-8-, and 9-10-year follow-up.]
• Effective orifice area (EOA) [Time frame: 1-, 3-5-, 6-8-, and 9-10-year follow-up.]
• Bioprosthetic valve dysfunction [Time frame: 1-, 3-5-, 6-8-, and 9-10-year follow-up.]
• Paravalvular leaks [Time frame: 1-, 3-5-, 6-8-, and 9-10-year follow-up.]
• Bioprosthetic valve dysfunction [Time frame: yearly]
• Bioprosthetic valve failure [Time frame: yearly]
• Bioprosthetic valve failure [Time frame: 1-, 3-5-, 6-8-, and 9-10-year follow-up.]
• Clinical events [Time frame: 1month and yearly up to 10-year]
• Valve thrombosis [Time frame: 1-3 months and yearly up to 10-year]
• Valve endocarditis [Time frame: 1-3 months and yearly up to 10-year]

Eligibility criteria

Inclusion criteria

• Inclusion criteria - Patients with severe aortic stenosis undergoing transarterial TAVR with the SAPIEN 3 Ultra RESILIA valve.
• Successful valve implantation of the SAPIEN 3 Ultra RESILIA valve.

VARC-3- defined technical success defined as:

• Freedom from mortality
• Successful access, delivery of the device, and retrieval of the delivery system
• Correct positioning of a single prosthetic heart valve into the proper anatomical location
• Freedom from surgery or intervention related to the device (excluding permanent pacemaker) or to a major vascular or access related, or cardiac structural complication - Absence of severe procedural or in-hospital complications (VARC-3 definitions): mortality, stroke, bleeding type 2-4, myocardial infarction, need for a second valve, valve embolization, coronary obstruction, annular rupture.

Exclusion criteria

• Age >80 years
• Severe pulmonary disease (FEV1 <50% predicted or need for home oxygen)
• Severe renal dysfunction (eGFR <30 ml/min/1.73m2)
• Frailty (Clinical Frailty Scale > 4)
• Severe coronary disease (SYNTAX score >32)
• Left ventricular ejection fraction ≤30%
• Moderate-to-severe mitral regurgitation
• Severe tricuspid regurgitation
• Pulmonary systolic pressure >60 mmHg
• STS-PROM >5%
• Any disease leading to a life expectancy <5 years

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model

Cohort

Study locations

Canada · 1 center

• IUCPQ — Québec

Publications

• Writing Committee Members; Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C; ACC/AHA Joint Committee Members; O'Gara PT, Beckman JA, Levine GN, Al-Khatib SM, Armbruster A, Birtcher KK, Ciggaroa J, Deswal A, Dixon DL, Fleisher LA, de las Fuentes L, Gentile F, Goldberger ZD, Gorenek PMID 33972115
• Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Juni P, Pierard L, Prendergast BD, Sadaba JR, Tribouilloy C, Wojakowski W; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022 Feb 12;43(7):561-632 PMID 34453165
• Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. PMID 30883058
• Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O'Hair D, Bajwa T, Heiser JC, Merhi W, Kleiman NS, Askew J, Sorajja P, Rovin J, Chetcuti SJ, Adams DH, Teirstein PS, Zorn GL 3rd, Forrest JK, Tchetche D, Resar J, Walton A, Piazza N, Ramlawi B, Robinson N, Petrossian G, Gleason TG, Oh JK, Boulware MJ, Qiao H, Mugglin AS, Reardon MJ; Evolut Low Risk Trial Investigators. Transcatheter Aortic-Valve Rep PMID 30883053
• Montarello NJ, Willemen Y, Tirado-Conte G, Travieso A, Bieliauskas G, Sondergaard L, De Backer O. Transcatheter aortic valve durability: a contemporary clinical review. Front Cardiovasc Med. 2023 May 9;10:1195397. doi: 10.3389/fcvm.2023.1195397. eCollection 2023. PMID 37229228
• Ferreira-Neto AN, Rodriguez-Gabella T, Guimaraes L, Freitas-Ferraz A, Bernier M, Figueiredo Guimaraes C, Pasian S, Paradis JM, Delarochelliere R, Dumont E, Mohammadi S, Kalavrouziotis D, Cote M, Pibarot P, Rodes-Cabau J. Multimodality evaluation of transcatheter structural valve degeneration at long-term follow-up. Rev Esp Cardiol (Engl Ed). 2021 Mar;74(3):247-256. doi: 10.1016/j.rec.2020.02.002. PMID 32278660
• Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1 PMID 20961243

Identifiers

NCT: NCT06420830 · RESILIA

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗