The ReTAVI Prospective Observational Registry

Официальное название

Evaluation of Clinical Outcomes of Patients Undergoing a Redo-TAVI Procedure; a Multicenter Prospective Observational Registry

Обзор

Patients with severe aortic stenosis (sAS) treated with transcatheter aortic valve implantation (TAVI) (increasingly younger \& lower risk pts) are experiencing SVD of the index THV and thus developing an indication for a redo-TAVI procedure. The evidence on redo-TAVI (where a transcatheter heart valve \[THV\] is implanted into another THV) is limited, with initial data showing acceptable safety as well efficacy in highly selected and limited populations. Aim is to evaluate short- and long-term data on patients undergoing transcatheter redo-TAVI procedures with THVs for failure of a previously implanted THV and to determine VARC-3 defined efficacy and safety at 30 days and functional outcome at 1 year, 3 years and 5 years.

Подробное описание

Between 1.4 and 2.8% of all patients undergoing transcatheter heart valve (THV) implantation require a second THV implanted into the previously implanted THV because of clinically significant aortic regurgitation \[1-3\]. 90% of THV-in-THV implants were considered successful although the mortality in the redo-TAVI group was higher at similar STS risks as in those with a successful first implant.

Redo-TAVI may also be a promising treatment strategy in degenerated THVs, but there is insufficient knowledge which strategy and valve design may result in the best outcomes \[4\]. Evidence so far reported is based on case reports and small case series, but not on a prospective, multicenter documentation.

Currently, \~ 5% of THV are implanted in degenerated surgical bioprosthetic valves. With the expanded use of THV for treatment of lower risk patients with severe aortic stenosis (sAS), it is estimated that the number of patients requiring re-treatment for THV failure is likely to rise within the next years.

Вмешательства

• Процедура Elective redo transcatheter aortic valve implantation (redo-TAVI)
  Elective redo-TAVI procedure with the intention to treat the patient with a SAPIEN family valve implantation (currently the only registered medical devices for redo-TAVI use)

Первичные конечные точки

• Efficacy: VARC-3 defined device success at 30 days [Срок оценки: 30 days]
• Technical success: Technical success (at exit from procedure room) [Срок оценки: end of intervention]
• Safety: VARC-3 defined early safety at 30 days [Срок оценки: 30 days]
• Procedural Outcomes (30 days) [Срок оценки: 30 days]
• Durability of the second aortic THV (30 days) [Срок оценки: 30 days]
• Durability of the second aortic THV (3 months) [Срок оценки: 3 months]
• Durability of the second aortic THV (12 months) [Срок оценки: 12 months]
• Durability of the second aortic THV (3 years) [Срок оценки: 3 years]
• Durability of the second aortic THV (5 years) [Срок оценки: 5 years]

Критерии участия

Критерии включения

Consecutive patients fulfilling the following criteria:

• Consenting adult patient (≥18 years)
• Procedural success of the first TAVI
• TAVI device failure of the index THV, irrespective of SVD severity
• Intention to treat the patient with a redo-TAVI procedure (SAPIEN family THV)
• The Local Heart Team and the Case Review Board consider the patient suitable and indicated for elective redo-TAVI
• Patient is scheduled to undergo a 30 Day and 12 Months follow-up (both visits taking place in the hospital)

Критерии исключения

• Patients without signed informed consent / data protection statement (according to requirements of local IRB/IEC)
• Life expectancy below 12 months
• Patients with largely incomplete data with respect to the aims of the project
• Pregnant women at the time of the redo-TAVI

Note: For all patients included a defined core data set will be collected prospectively. All patients being in accordance with above stated inclusion and exclusion criteria and receiving a balloon-expandable transcatheter aortic valve will be included in the extended documentation.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Франция · 13 центров

• Centre Hospitalier Universitaire de Bordeaux — Bordeaux
• Centre Hospitalier Universitaire de Clermont-Ferrand — Clermont-Ferrand
• Centre Hospitalier Universitaire de Lille — Lille
• Hospices Civils de Lyon — Lyon
• Hôpitaux Universitaires de Marseille Timone — Marseille
• Jacques Cartier Private Hospital, Massy — Massy
• Centre Hospitalier Universitaire de Nantes — Nantes
• Hôpital Européen Georges-Pompidou — Paris
• … и ещё 5 центров

Италия · 11 центров

• AOU Ospedali Riuniti Ancona, Umberto I, G. M. Lancisi, G. Salesi — Ancona
• IRCCS Azienda Ospedaliero Universitaria di Bologna — Bologna
• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia — Brescia
• Careggi Hospital — Florence
• IRCCS Ospedale Galeazzi Sant'Ambrogio — Milan
• Azienda Ospedale-Università Padova (AOUP) — Padua
• Azienda Ospedaliero-Universitaria Pisana — Pisa
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma
• … и ещё 3 центра

Германия · 10 центров

• University Heart Center Freiburg Bad Krozingen — Bad Krozingen
• Kerckhoff-Klinik GmbH, UKGM GmbH — Bad Nauheim
• Heart and Diabetes Center North Rhine-Westphalia — Bad Oeynhausen
• German Heart Center of Charité Berlin — Berlin
• BG University Hospital Bergmannsheil gGmbH — Bochum
• University Hospital of Duesseldorf — Düsseldorf
• Elisabeth Hospital, Essen — Essen
• German Heart Centre Munich — Munich
• … и ещё 2 центра

Польша · 7 центров

• Medical University of Bialystok — Bialystok
• University Clinical Centre of Gdańsk — Gdansk
• Medical University of Silesia — Katowice
• University Hospital of Kraków — Krakow
• Medical University of Warsaw — Warsaw
• Institute of Cardiology Warsaw — Warsaw
• Wroclaw Medical University — Wroclaw

Испания · 7 центров

• Hospital de la Santa Creu i Sant Pau — Barcelona
• Hospital Clinic de Barcelona — Barcelona
• Hospital University Germans Trias i Pujol — Barcelona
• Hospital Universitario de León — León
• Hospital Clinico Universitario San Carlos — Madrid
• Hospital Universitario Central de Asturias — Oviedo
• Hospital Álvaro Cunqueiro, Vigo — Vigo

Австрия · 4 центра

• LKH-University Hospital and Medical University of Graz — Graz
• Kepler University Clinic Linz — Linz
• University Hospital St. Pölten — Sankt Pölten
• Medical University of Vienna — Vienna

Канада · 3 центра

• McGill University Health Centre — Montreal
• Institut Universitaire de Cardiologie et de Pneumologie — Québec
• St. Paul's Hospital, Vancouver — Vancouver

Швейцария · 3 центра

• University Hospital of Basel — Basel
• Hôpitaux universitaires de Genève — Geneva
• Centre hospitalier universitaire vaudois et Université de Lausanne — Lausanne

Португалия · 2 центра

• Hospital de Santa Cruz, Carnaxide-Lisabon — Carnaxide
• Centro Hospitalar Vila Nova de Gaia / Espinho — Vila Nova de Gaia

Израиль · 1 центр

• Tel Aviv Medical Center — Tel Aviv

Нидерланды · 1 центр

• St. Antonius Ziekenhuis, Nieuwegein — Nieuwegein

Публикации

• 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. Eur Heart J. 2021 May 14;42(1 PMID 33871579
• Tarantini G, Delgado V, de Backer O, Sathananthan J, Treede H, Saia F, Blackman D, Parma R. Redo-Transcatheter Aortic Valve Implantation Using the SAPIEN 3/Ultra Transcatheter Heart Valves-Expert Consensus on Procedural Planning and Techniques. Am J Cardiol. 2023 Apr 1;192:228-244. doi: 10.1016/j.amjcard.2023.01.010. Epub 2023 Jan 27. PMID 36710143
• 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
• Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. d PMID 21639811
• Toggweiler S, Wood DA, Rodes-Cabau J, Kapadia S, Willson AB, Ye J, Cheung A, Leipsic J, Binder RK, Gurvitch R, Freeman M, Thompson CR, Svensson LG, Dumont E, Tuzcu EM, Webb JG. Transcatheter valve-in-valve implantation for failed balloon-expandable transcatheter aortic valves. JACC Cardiovasc Interv. 2012 May;5(5):571-577. doi: 10.1016/j.jcin.2012.03.008. PMID 22625197
• Kamioka N, Caughron H, Corrigan F, Block P, Babaliaros V. Supra-annular valve strategy for an early degenerated transcatheter balloon-expandable heart valve. Catheter Cardiovasc Interv. 2018 Dec 1;92(7):1458-1460. doi: 10.1002/ccd.27506. Epub 2018 Jan 23. PMID 29359409
• Webb JG, Mack MJ, White JM, Dvir D, Blanke P, Herrmann HC, Leipsic J, Kodali SK, Makkar R, Miller DC, Pibarot P, Pichard A, Satler LF, Svensson L, Alu MC, Suri RM, Leon MB. Transcatheter Aortic Valve Implantation Within Degenerated Aortic Surgical Bioprostheses: PARTNER 2 Valve-in-Valve Registry. J Am Coll Cardiol. 2017 May 9;69(18):2253-2262. doi: 10.1016/j.jacc.2017.02.057. PMID 28473128
• Deeb GM, Chetcuti SJ, Reardon MJ, Patel HJ, Grossman PM, Schreiber T, Forrest JK, Bajwa TK, O'Hair DP, Petrossian G, Robinson N, Katz S, Hartman A, Dauerman HL, Schmoker J, Khabbaz K, Watson DR, Yakubov SJ, Oh JK, Li S, Kleiman NS, Adams DH, Popma JJ. 1-Year Results in Patients Undergoing Transcatheter Aortic Valve Replacement With Failed Surgical Bioprostheses. JACC Cardiovasc Interv. 2017 May 22 PMID 28521921

Идентификаторы

NCT: NCT05601453 · ReTAVI Registry

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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