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The aim of this collaborative analysis is to evaluate stroke rates and mortality in patients undergoing TAVI with the self-expandable MCV prosthesis compared to the balloon-expandable ES valve. In the absence of large randomized controlled trials, we will conduct a large collaborative patient-pooled meta-analysis on 30-day stroke and mortality in patients undergoing primary transfemoral TAVI with either MCV or ES valve.
The main aim of this patient-pooled analyses is to compare stroke rates and mortality in patients undergoing TAVI with the self-expandable MCV prosthesis compared to the balloon-expandable ES valve. However, this collaboration may also be used to compare various outcomes.
Studies were included if they complied with the following requirements: original prospective studies, including patients with aortic valve stenosis treated with transfemoral TAVI of native valves and reporting of 30 day stroke outcomes according to VARC criteria or other specified corresponding criteria . Moreover, to be included studies had to report both the use of self-expandable MCV prosthesis and the balloon-expandable ES valve in more than 50 patients in each arm to ensure experience in use of the valves. Studies were excluded if they only addressed patients undergoing valve-in-valve and re-do procedures or bicuspid valves or included the same study population. Principal Investigators of these studies were approached for collaboration.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcatheter aortic valve implantation | Procedure | Patients with severe aortic valve stenosis undergo transcatheter aortic valve implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Death during the first month after TAVI | 30 days |
| Stroke | Stroke during the first month after TAVI | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pacemaker implantation | Pacemaker during the first month after TAVI | 30 days |
| Bleeding | Major or life-threatening bleeding during the first month after TAVI |
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Inclusion Criteria:
Exclusion Criteria:
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patients undergoing transfemoral transcatheter aortic valve procedures
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| Name | Affiliation | Role |
|---|---|---|
| Jan Piek, Prof. | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Medical Center | Amsterdam | 1105AZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42013298 | Derived | Hemelrijk KI, van Nieuwkerk AC, Vojacek PJ, Gheorge L, Tchetche D, Brito FS Jr, Barbanti M, Kornowski R, Latib A, D'Onofrio A, Ribichini F, Bowden GY, Dumonteil N, Leite RS, Sartori S, D'Errigo P, Tarantini G, Andreaggi S, Orvin K, Pagnesi M, Asmarats L, Dangas G, Mehran R, Delewi R. Pre-Existing and New-Onset Atrial Fibrillation in Patients Undergoing Transcatheter Aortic Valve Implantation. Catheter Cardiovasc Interv. 2026 Apr 21. doi: 10.1002/ccd.70632. Online ahead of print. | |
| 39814498 |
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Collaborators are invited to participate in analyses
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| 30 days |
| New onset atrial fibrillation | New onset atrial fibrillation during the first month after TAVI | 30 days |
| Myocardial infarction | Myocardial infarction during the first month after TAVI | 30 days |
| Derived |
| Aarts HM, van Nieuwkerk AC, Hemelrijk KI, Salgado Fernandez J, Tchetche D, de Brito FS Jr, Barbanti M, Kornowski R, Latib A, D'Onofrio A, Ribichini F, Ferrer MC, Dumonteil N, Abizaid A, Sartori S, D'Errigo P, Tarantini G, Del Sole AP, Orvin K, Pagnesi M, Pinar E, Dangas G, Mehran R, Voskuil M, Delewi R. Surgical Bailout in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement: Incidence, Trends, and Clinical Outcomes. JACC Cardiovasc Interv. 2025 Jan 13;18(1):89-99. doi: 10.1016/j.jcin.2024.09.050. |
| 39190595 | Derived | van Nieuwkerk AC, Aarts HM, Hemelrijk KI, Urbano Carrillo C, Tchetche D, de Brito FS Jr, Barbanti M, Kornowski R, Latib A, D'Onofrio A, Ribichini F, Garcia-Blas S, Dumonteil N, Abizaid A, Sartori S, D'Errigo P, Tarantini G, Lunardi M, Orvin K, Pagnesi M, Navarro F, Dangas G, Mehran R, Delewi R. Cerebrovascular Events in Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation: A Pooled Patient-Level Study. J Am Heart Assoc. 2024 Sep 3;13(17):e032901. doi: 10.1161/JAHA.123.032901. Epub 2024 Aug 27. |
| 38151309 | Derived | van Nieuwkerk AC, Aarts HM, Hemelrijk KI, Canton T, Tchetche D, de Brito FS Jr, Barbanti M, Kornowski R, Latib A, D'Onofrio A, Ribichini F, Maneiro Melon N, Dumonteil N, Abizaid A, Sartori S, D'Errigo P, Tarantini G, Fabroni M, Orvin K, Pagnesi M, Vicaino Arellano M, Dangas G, Mehran R, Voskuil M, Delewi R. Bleeding in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement: Incidence, Trends, Clinical Outcomes, and Predictors. JACC Cardiovasc Interv. 2023 Dec 25;16(24):2951-2962. doi: 10.1016/j.jcin.2023.10.011. |
| 36384656 | Derived | van Nieuwkerk AC, Santos RB, Mata RB, Tchetche D, de Brito FS Jr, Barbanti M, Kornowski R, Latib A, D'Onofrio A, Ribichini F, Baan J, Oteo-Dominguez J, Dumonteil N, Abizaid A, Sartori S, D'Errigo P, Tarantini G, Lunardi M, Orvin K, Pagnesi M, Ghattas A, Amat-Santos I, Dangas G, Mehran R, Delewi R. Diabetes mellitus in transfemoral transcatheter aortic valve implantation: a propensity matched analysis. Cardiovasc Diabetol. 2022 Nov 16;21(1):246. doi: 10.1186/s12933-022-01654-x. |
| 30871358 | Derived | Vlastra W, Jimenez-Quevedo P, Tchetche D, Chandrasekhar J, de Brito FS Jr, Barbanti M, Kornowski R, Latib A, D'Onofrio A, Ribichini F, Baan J, Tijssen JGP, De la Torre Hernandez JM, Dumonteil N, Sarmento-Leite R, Sartori S, Rosato S, Tarantini G, Lunardi M, Orvin K, Pagnesi M, Hernandez-Antolin R, Modine T, Dangas G, Mehran R, Piek JJ, Delewi R. Predictors, Incidence, and Outcomes of Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation Complicated by Stroke. Circ Cardiovasc Interv. 2019 Mar;12(3):e007546. doi: 10.1161/CIRCINTERVENTIONS.118.007546. |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |
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