Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR

Официальное название

Valve Hemodynamic Optimization Based on Doppler-Echocardiography Versus Catheterization Measurements Following Valve-in-Valve TAVR: A Prospective Randomized Trial

Обзор

Data on valve performance following ViV-TAVR has usually been obtained with the use of Doppler-echocardiography. However, some reports have shown significant discordances in the evaluation of mean transvalvular gradient between echocardiography and catheterization, with an overestimation of the real gradient with echo (vs. cath) in most cases. Thus, the incidence of procedural-device failure may be lower than that reported in the ViV-TAVR literature,

Подробное описание

This is a prospective, multicenter, randomized, single-blinded design trial including patients with surgical aortic bioprosthetic dysfunction in the presence of a stented surgical bioprosthesis with a labeled size ≤25 mm. Following the Heart Team's decision to proceed with a ViV-TAVR procedure with the SAPIEN 3 ULTRA valve (or its subsequent iterations), patients will be randomized to valve hemodynamic optimization according to Doppler-echocardiography versus cardiac catheterization parameters.

Вмешательства

• Процедура Doppler-echocardiography
  The TAVR (valve-in-valve) procedure will be performed with the SAPIEN 3 Ultra valve, with valve sizing according to current manufacturer recommendations. Following valve implantation, further intervention will be based on Doppler-echocardiographic measurements. Balloon post-dilation with a non-compliant balloon will be performed in the presence of a residual mean gradient ≥20 mmHg as assessed by Doppler-echocardiography.
• Процедура Invasive hemodynamic measurements
  The TAVR (valve-in-valve) procedure will be performed with the SAPIEN 3 Ultra valve, with valve sizing according to current manufacturer recommendations. Following valve implantation, further interventions will be based on invasive hemodynamic measurements (with simultaneous aortic and ventricular pressure recording). Balloon post-dilation will be performed with a non-compliant balloon in the presence of a mean residual gradient ≥20 mmHg as assessed by hemodynamic measurements.

Первичные конечные точки

• Changes in Quality of life (Efficacy) [Срок оценки: 12 months follow-up]
• Periprocedural complications (Safety) [Срок оценки: Periprocedural]

Вторичные конечные точки (12)

• Residual transvalvular gradient [Срок оценки: 1 month and 12 months follow-up]
• Combined enpoint: Moderate or severe prothesis-patient mismatch and/or moderate or severe aortic regurgitation (valve performance) [Срок оценки: 1 month and 12 months follow-up]
• Heart failure [Срок оценки: 1 and 12 months follow-up and yearly up to 5 years]
• Exercise capacity [Срок оценки: 1 month and 12 months follow-up]
• Changes in Quality of life [Срок оценки: after 1-year follow-up (yearly up to 5 years)]
• Clinical safety endpoints [Срок оценки: 1 and 12 months follow-up and yearly up to 5 years]
• re-hospitalization [Срок оценки: 1 and 12 months follow-up and yearly up to 5 years]
• wear and tear deterioration (Structural valve degeneration) [Срок оценки: 1 and 12 months follow-up and yearly up to 5 years]
• Leaflet disruption (Structural valve degeneration) [Срок оценки: 1 and 12 months follow-up and yearly up to 5 years]
• flail leaflet (Structural valve degeneration) [Срок оценки: 1 and 12 months follow-up and yearly up to 5 years]
• leaflet fibrosis and/or calcification (Structural valve degeneration) [Срок оценки: 1 and 12 months follow-up and yearly up to 5 years]
• strut fracture or deformation (Structural valve degeneration) [Срок оценки: 1 and 12 months follow-up and yearly up to 5 years]

Критерии участия

Критерии включения

• Patients with surgical aortic bioprosthetic valve failure defined as severe aortic stenosis and/or regurgitation approved for a valve-in-valve procedure by the Heart Team
• Surgical stented bioprosthetic valve (label size ≤25 mm)
• TAVR with the SAPIEN 3 Ultra valve

Критерии исключения

• Stentless or sutureless surgical valves
• Trifecta bioprosthesis
• Hancock II bioprosthesis
• High-risk of coronary obstruction (defined either as a virtual transcatheter valve - coronary distance as evaluated by CT <4 mm or based on the criterion of the heart team responsible for the procedure).
• Impossibility to obtain written informed consent

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 6 центров

• University of California — San Francisco
• South Broward Hospital Disctrict D/B/A Memorial Healthcare System — Hollywood
• William Beaumont Hospital — Royal Oak
• Mayo Clinic — Rochester
• St-Joseph's Health INC — Syracuse
• The Christ Hospital Health Network — Cincinnati

Канада · 1 центр

• IUCPQ — Québec

Публикации

• Paradis JM, Del Trigo M, Puri R, Rodes-Cabau J. Transcatheter Valve-in-Valve and Valve-in-Ring for Treating Aortic and Mitral Surgical Prosthetic Dysfunction. J Am Coll Cardiol. 2015 Nov 3;66(18):2019-2037. doi: 10.1016/j.jacc.2015.09.015. PMID 26516006
• VARC-3 WRITING COMMITTEE:; Genereux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, Bax JJ, Leipsic JA, Blanke P, Blackstone EH, Finn MT, Kapadia S, Linke A, Mack MJ, Makkar R, Mehran R, Popma JJ, Reardon M, Rodes-Cabau J, Van Mieghem NM, Webb JG, Cohen DJ, Leon MB. Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research. J Am Coll Cardiol. 2021 Jun PMID 33888385
• Dvir D, Webb JG, Bleiziffer S, Pasic M, Waksman R, Kodali S, Barbanti M, Latib A, Schaefer U, Rodes-Cabau J, Treede H, Piazza N, Hildick-Smith D, Himbert D, Walther T, Hengstenberg C, Nissen H, Bekeredjian R, Presbitero P, Ferrari E, Segev A, de Weger A, Windecker S, Moat NE, Napodano M, Wilbring M, Cerillo AG, Brecker S, Tchetche D, Lefevre T, De Marco F, Fiorina C, Petronio AS, Teles RC, Testa L PMID 25005653
• Bleiziffer S, Simonato M, Webb JG, Rodes-Cabau J, Pibarot P, Kornowski R, Windecker S, Erlebach M, Duncan A, Seiffert M, Unbehaun A, Frerker C, Conzelmann L, Wijeysundera H, Kim WK, Montorfano M, Latib A, Tchetche D, Allali A, Abdel-Wahab M, Orvin K, Stortecky S, Nissen H, Holzamer A, Urena M, Testa L, Agrifoglio M, Whisenant B, Sathananthan J, Napodano M, Landi A, Fiorina C, Zittermann A, Veulema PMID 32592401
• de Freitas Campos Guimaraes L, Urena M, Wijeysundera HC, Munoz-Garcia A, Serra V, Benitez LM, Auffret V, Cheema AN, Amat-Santos IJ, Fisher Q, Himbert D, Garcia Del Blanco B, Dager A, Le Breton H, Paradis JM, Dumont E, Pibarot P, Rodes-Cabau J. Long-Term Outcomes After Transcatheter Aortic Valve-in-Valve Replacement. Circ Cardiovasc Interv. 2018 Sep;11(9):e007038. doi: 10.1161/CIRCINTERVENTIONS.118 PMID 30354588
• Wernly B, Zappe AK, Unbehaun A, Sinning JM, Jung C, Kim WK, Fichtlscherer S, Lichtenauer M, Hoppe UC, Alushi B, Beckhoff F, Wewetzer C, Franz M, Kretzschmar D, Navarese E, Landmesser U, Falk V, Lauten A. Transcatheter valve-in-valve implantation (VinV-TAVR) for failed surgical aortic bioprosthetic valves. Clin Res Cardiol. 2019 Jan;108(1):83-92. doi: 10.1007/s00392-018-1326-z. Epub 2018 Jul 12. PMID 30003366
• Webb JG, Murdoch DJ, Alu MC, Cheung A, Crowley A, Dvir D, Herrmann HC, Kodali SK, Leipsic J, Miller DC, Pibarot P, Suri RM, Wood D, Leon MB, Mack MJ. 3-Year Outcomes After Valve-in-Valve Transcatheter Aortic Valve Replacement for Degenerated Bioprostheses: The PARTNER 2 Registry. J Am Coll Cardiol. 2019 Jun 4;73(21):2647-2655. doi: 10.1016/j.jacc.2019.03.483. PMID 31146808
• Kaneko T, Makkar RR, Krishnaswami A, Hermiller J, Greenbaum A, Babaliaros V, Shah PB, Bailey SH, Bapat V, Kapadia S, Abbas AE. Valve-in-Surgical-Valve With SAPIEN 3 for Transcatheter Aortic Valve Replacement Based on Society of Thoracic Surgeons Predicted Risk of Mortality. Circ Cardiovasc Interv. 2021 May;14(5):e010288. doi: 10.1161/CIRCINTERVENTIONS.120.010288. Epub 2021 May 18. PMID 34003666

Идентификаторы

NCT: NCT05459233 · ECHOCATH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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