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| Name | Class |
|---|---|
| Edwards Lifesciences | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| redo-TAVI patients | Patients with severe aortic stenosis (sAS) treated with TAVI developing SVD and thus an indication for redo-TAVI procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elective redo transcatheter aortic valve implantation (redo-TAVI) | Procedure | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: VARC-3 defined device success at 30 days | Determine VARC-3 defined device success at 30 days
(Different definitions, in addition to the predefined such as the consideration of higher gradients than 20 mmHg, will be explored) These events will be adjudicated. Number and percentage of subjects with device success at 30 days as per VARC-3 definition, along with individual component of the success, will be presented. | 30 days |
| Technical success: Technical success (at exit from procedure room) | Technical success at exit from procedure room defined as:
Number and percentage of subjects with technical success at exit from procedure room, along with individual component of the success, will be presented. | end of intervention |
| Safety: VARC-3 defined early safety at 30 days | Determine VARC-3 defined early safety at 30 days:
These events will be adjudicated. Number and percentage of subjects with early safety at 30 days as per VARC-3 definition, along with individual component of the success, will be presented. | 30 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Compliance with recommendation | It will be assessed and percentages determined whether participating centers follow the published recommendation (itemized, compliance being voluntary). | 12 months |
| Impact of alterations to published recommendations |
Inclusion Criteria:
Consecutive patients fulfilling the following criteria:
Exclusion Criteria:
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.
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Patients with an indication for a redo-TAVI procedure considered eligible by the Local Heart Team and the Case Review Board for a SAPIEN family valve implantation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claudia Lüske, PhD | Contact | 044718503324 | +49 | claudia.lueske@ippmed.de |
| Daniel Greinert | Contact | 044718503328 | +49 | daniel.greinert@ippmed.de |
| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Tarantini, Prof. | University of Padua Medical School, Padua, Italy | Principal Investigator |
| Radoslaw Parma, Dr. | Medical University of Silesia, Katowice, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LKH-University Hospital and Medical University of Graz | Recruiting | Graz | 8010 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33871579 | Background | 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(19):1825-1857. doi: 10.1093/eurheartj/ehaa799. | |
| 36710143 |
| Label | URL |
|---|---|
| The ReTAVi Registry webpage provides you with general details about the trial and gives you an overview of participating trial sites. | View source |
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no individual participant data (IPD) will be shared
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|
| Procedural Outcomes (30 days) | Procedural outcomes at 30 days, defined as:
Number and percentage of subjects with above specified outcomes at 30 days , along with individual component of the success, will be presented. | 30 days |
| Durability of the second aortic THV (30 days) | Determine the durability of the second aortic THV:
Definition of transcatheter heart valve thrombosis Clinical sequelae of a thromboembolic event (e.g. stroke, TIA, retinal occlusion, other evidence of systemic thromboembolism) or worsening valve stenosis/ regurgitation (e.g. signs of heart failure, syncope) and
Number and percentage of subjects with above specified criteria at 3 months, along with individual component of the success, will be presented. | 30 days |
| Durability of the second aortic THV (3 months) | Determine the durability of the second aortic THV:
For the definition of transcatheter cardiac valve thrombosis, please refer to Outcome 5. Number and percentage of subjects with above specified criteria at 3 months, along with individual component of the success, will be presented. | 3 months |
| Durability of the second aortic THV (12 months) | Determine the durability of the second aortic THV:
For the definition of transcatheter cardiac valve thrombosis, please refer to Outcome 5. Number and percentage of subjects with above specified criteria at 12 months , along with individual component of the success, will be presented. | 12 months |
| Durability of the second aortic THV (3 years) | Determine the durability of the second aortic THV:
For the definition of transcatheter cardiac valve thrombosis, please refer to Outcome 5. | 3 years |
| Durability of the second aortic THV (5 years) | Determine the durability of the second aortic THV:
For the definition of transcatheter cardiac valve thrombosis, please refer to Outcome 5. | 5 years |
The impact of potential alterations to the protocol on the procedural outcomes will be elucidated and descriptively described.
| 12 months |
| Discretionary longer-term follow-up | Discretionary longer-term follow-up in terms of durability of the second aortic THV:
For the definition of transcatheter cardiac valve thrombosis, please refer to Outcome 5. Number and percentage of subjects with above specified criteria with up to 5 years follow-up, along with individual component of the success, will be presented. | up to 5 years |
| Exploratory objectives | Further, not predefined research questions will be explored based on the dataset such as:
| 12 months |
| Thomas Cuisset, Prof. | Centre Hospitalier Universitaire de Timone, Marseille, France | Study Chair |
| Victoria Delgado, Prof. | University Hospital Germans Trias i Pujol, Badalona, Spain | Study Chair |
| Michael Joner, Prof. | German Heart Center, Technical University of Munich, Munich, Germany | Study Chair |
| Thomas Modine, Prof. | Hopital Haut Levêque - Centre Hospitalier Universitaire de Bordeaux, France | Study Chair |
| Josep Rodés-Cabau, Prof. | nstitut Universitaire de Cardiologie et de Pneumologie de Québec, Canada | Study Chair |
| Francesco Saia, Prof. | University Hospital of Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy | Study Chair |
| Hector A. Alvarez Covarrubias, MD | Department of Cardiology, Munich Heart Center, Technical University of Munich, Germany | Study Chair |
| Ginatutas Bieliauskas, MD | Department Interventional Cardiology, The Heart Center, Rigshospitalet, University of Copenhagen, Coppenhagen, Denmark | Study Chair |
| Luca Nai Fovino, MD | Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua Medical School, Padua, Italy | Study Chair |
| Eric Van Belle, MD | Interventional Cardiology, Centre Hospitalier Universitaire de Lille, France | Study Chair |
| Rafał Wolny, MD | Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warsaw, Poland | Study Chair |
| Kepler University Clinic Linz | Recruiting | Linz | 4020 | Austria |
|
| University Hospital St. Pölten | Recruiting | Sankt Pölten | 3100 | Austria |
|
| Medical University of Vienna | Recruiting | Vienna | 1090 | Austria |
|
| McGill University Health Centre | Recruiting | Montreal | H4A 3J1 | Canada |
|
| Institut Universitaire de Cardiologie et de Pneumologie | Recruiting | Québec | QC G1V 4G5 | Canada |
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| St. Paul's Hospital, Vancouver | Recruiting | Vancouver | BC V6Z 1Y6 | Canada |
|
| Centre Hospitalier Universitaire de Bordeaux | Recruiting | Bordeaux | 33604 | France |
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| Centre Hospitalier Universitaire de Clermont-Ferrand | Recruiting | Clermont-Ferrand | 63003 | France |
|
| Centre Hospitalier Universitaire de Lille | Recruiting | Lille | 59037 | France |
|
| Hospices Civils de Lyon | Recruiting | Lyon | 69677 | France |
|
| Hôpitaux Universitaires de Marseille Timone | Recruiting | Marseille | 13005 | France |
|
| Jacques Cartier Private Hospital, Massy | Recruiting | Massy | 91300 | France |
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| Centre Hospitalier Universitaire de Nantes | Recruiting | Nantes | 44093 | France |
|
| Hôpital Européen Georges-Pompidou | Recruiting | Paris | 75015 | France |
|
| Hôpital Bichat-Claude-Bernard | Recruiting | Paris | 75018 | France |
|
| Centre hospitalier universitaire de Rennes | Recruiting | Rennes | 35033 | France |
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| Centre Hospitalier Universitaire de Rouen | Recruiting | Roubaix | 76000 | France |
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| Clinique de la Porte de Paris (CCN) | Recruiting | Saint-Denis | 93200 | France |
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| Centre Hospitalier Universitaire de Toulouse | Recruiting | Toulouse | 31059 | France |
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| University Heart Center Freiburg Bad Krozingen | Recruiting | Bad Krozingen | 79189 | Germany |
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| Kerckhoff-Klinik GmbH, UKGM GmbH | Recruiting | Bad Nauheim | 61231 | Germany |
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| Heart and Diabetes Center North Rhine-Westphalia | Recruiting | Bad Oeynhausen | 32545 | Germany |
|
| German Heart Center of Charité Berlin | Recruiting | Berlin | 13353 | Germany |
|
| BG University Hospital Bergmannsheil gGmbH | Recruiting | Bochum | 44789 | Germany |
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| University Hospital of Duesseldorf | Recruiting | Düsseldorf | 40225 | Germany |
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| Elisabeth Hospital, Essen | Recruiting | Essen | 45138 | Germany |
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| German Heart Centre Munich | Recruiting | Munich | 80636 | Germany |
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| Robert-Bosch-Hospital, Stuttgart | Recruiting | Stuttgart | 70376 | Germany |
|
| University Hospital Ulm | Recruiting | Ulm | 89070 | Germany |
|
| Tel Aviv Medical Center | Recruiting | Tel Aviv | 6423906 | Israel |
|
| AOU Ospedali Riuniti Ancona, Umberto I, G. M. Lancisi, G. Salesi | Withdrawn | Ancona | 60126 | Italy |
| IRCCS Azienda Ospedaliero Universitaria di Bologna | Recruiting | Bologna | 40138 | Italy |
|
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia | Recruiting | Brescia | 25123 | Italy |
|
| Careggi Hospital | Recruiting | Florence | 50134 | Italy |
|
| IRCCS Ospedale Galeazzi Sant'Ambrogio | Recruiting | Milan | 20157 | Italy |
|
| Azienda Ospedale-Università Padova (AOUP) | Recruiting | Padua | 35128 | Italy |
|
| Azienda Ospedaliero-Universitaria Pisana | Recruiting | Pisa | 56124 | Italy |
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| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | Roma | 00168 | Italy |
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| Policlinici universitari | Sapienza Università di Roma | Recruiting | Roma | 00185 | Italy |
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| Università degli Studi di Trieste | Recruiting | Trieste | 34149 | Italy |
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| Ospedale San Bortolo di Vicenza | Recruiting | Vicenza | 36100 | Italy |
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| St. Antonius Ziekenhuis, Nieuwegein | Recruiting | Nieuwegein | 3435 | Netherlands |
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| Medical University of Bialystok | Recruiting | Bialystok | 15-089 | Poland |
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| University Clinical Centre of Gdańsk | Withdrawn | Gdansk | 80-952 | Poland |
| Medical University of Silesia | Withdrawn | Katowice | 40-055 | Poland |
| University Hospital of Kraków | Recruiting | Krakow | 31-501 | Poland |
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| Medical University of Warsaw | Recruiting | Warsaw | 02-091 | Poland |
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| Institute of Cardiology Warsaw | Recruiting | Warsaw | 04-628 | Poland |
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| Wroclaw Medical University | Recruiting | Wroclaw | 50-368 | Poland |
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| Hospital de Santa Cruz, Carnaxide-Lisabon | Recruiting | Carnaxide | 2790-134 | Portugal |
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| Centro Hospitalar Vila Nova de Gaia / Espinho | Recruiting | Vila Nova de Gaia | 4434-502 | Portugal |
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| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | 08025 | Spain |
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| Hospital Clinic de Barcelona | Recruiting | Barcelona | 08036 | Spain |
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| Hospital University Germans Trias i Pujol | Recruiting | Barcelona | 08916 | Spain |
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| Hospital Universitario de León | Recruiting | León | 24008 | Spain |
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| Hospital Clinico Universitario San Carlos | Recruiting | Madrid | 28040 | Spain |
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| Hospital Universitario Central de Asturias | Recruiting | Oviedo | 33011 | Spain |
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| Hospital Álvaro Cunqueiro, Vigo | Recruiting | Vigo | 36312 | Spain |
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| University Hospital of Basel | Recruiting | Basel | 4031 | Switzerland |
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| Hôpitaux universitaires de Genève | Recruiting | Geneva | 1205 | Switzerland |
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| Centre hospitalier universitaire vaudois et Université de Lausanne | Recruiting | Lausanne | 1011 | Switzerland |
|
| Background |
| 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. |
| 20961243 | Background | 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):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22. |
| 21639811 | Background | 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. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5. |
| 22625197 | Background | 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. |
| 29359409 | Background | 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. |
| 28473128 | Background | 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. |
| 28521921 | Background | 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;10(10):1034-1044. doi: 10.1016/j.jcin.2017.03.018. |
| 30175405 | Background | Kopp-Schneider A, Wiesenfarth M, Witt R, Edelmann D, Witt O, Abel U. Monitoring futility and efficacy in phase II trials with Bayesian posterior distributions-A calibration approach. Biom J. 2019 May;61(3):488-502. doi: 10.1002/bimj.201700209. Epub 2018 Sep 2. |
| 42219979 | Derived | Tarantini G, Fovino LN, Alvarez Covarrubias HA, Wolny R, Fabris T, Skipirzepa JN, Eden M, Zamorano JL, Joner M, Cuisset T, Delgado V, Rodes-Cabau J, Saia F, Bieliauskas G, Van Belle E, Modine T, Rheude T, Garot P, Jung C, Rudolph TK, Leroux L, Rottbauer W, Nestelberger T, Lhermusier T, Nejjari M, Regueiro A, Meier D, Fraccaro C, Hartikainen T, Karam N, Swaans M, Rodrigues A, Dreger H, Hengstenberg C, Schmitz T, Mauler-Wittwer S, Piazza N, Combaret N, Letocart V, Auffret V, Durand E, Urena-Alcazar M, Del Valle-Fernandez R, Drago A, De Carlo M, Jimenez Diaz VA, Dabrowski M, Mascherbauer J, Sudre A, Ong P, Gonska B, Mancone M, Fabris E, Teles RC, Nombela-Franco L, Asmarats L, Vilalta V, Protasiewicz M, Webb JG, Toth-Gayor G, Zierer A, Rioufol G, Seiffert M, Adamo M, Meucci F, Ielasi A, Burzotta F, Lopez Benito M, Loewenstein I, Kralisz P, Legutko J, Huczek Z, Pavei A, Rakova R, Wesselink W, Zielinski M, Trushina N, Bramlage P, Parma R. Early outcomes of redo-TAVI with the SAPIEN 3 platform: the prospective, multicentre ReTAVI registry. EuroIntervention. 2026 Jun 1;22(11):e629-e641. doi: 10.4244/EIJ-D-25-01268. |
| ID | Term |
|---|---|
| D011475 | Prosthesis Failure |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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