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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (10)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Канада · 1 центр

• IUCPQ — Québec

Публикации

• 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
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• 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
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Идентификаторы

NCT: NCT06420830 · RESILIA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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