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| Name | Class |
|---|---|
| IRCCS Policlinico S. Donato | OTHER |
| University Hospital, Catania | OTHER |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | OTHER |
| Hospital ClÃnico Universitario de Valladolid |
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Periprocedural bleeding events are frequent during transcatheter aortic valve implantation (TAVI), mainly driven by vascular complications and are associated to a worse prognosis. Therefore, red blood cell (RBC) transfusion is often required, although it is associated with worsened outcomes.
There is no consensus on the optimal transfusion strategy after bleeding. The Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) will be a multicenter retrospective registry enrolling consecutive patients who underwent TAVI; the primary aim of the study will be to test whether RBC transfusion is a marker or an independent predictor of adverse events.
Periprocedural bleeding events are frequent during transcatheter aortic valve implantation (TAVI), mainly driven by vascular complications and are associated to a worse prognosis. Therefore, red blood cell (RBC) transfusion is often required, although it is associated with worsened outcomes.
There is no consensus on the optimal transfusion strategy after bleeding: among patients undergoing cardiac surgery, the Transfusion Requirements in Cardiac Surgery (TRICS) III trial documented that a restrictive RBC transfusion strategy (if hemoglobin level was <7.5 g/dl) was noninferior to a liberal approach (if hemoglobin level was <9.5 g/dl) with respect to the composite occurrence of death, myocardial infarction (MI), stroke, or new-onset renal failure with dialysis.
The Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) will be a multicenter retrospective registry enrolling consecutive patients who underwent TAVI; the primary aim of the study will be to test whether RBC transfusion is a marker or an independent predictor of adverse events. Patients will be stratified according to their lowest hemoglobin value (>9.5 g/dl, 7.5-9.5 g/dl and <7.5 g/dl) and to whether they received or not periprocedural RBC transfusion.
The primary endpoint will be the 30-day occurrence of major adverse cardiovascular events (MACE), as death, myocardial infarction (MI), stroke, or acute kidney injury (AKI, as absolute increase in serum creatinine ≥0.3 mg/dL [≥26.4 μmol/L] or ≥50% increase ≤72 hours).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transfusion | Patients requiring blood transfusion after transcatheter aortic valve implantation (TAVI) |
| |
| No Transfusion | Patients not requiring blood transfusion after transcatheter aortic valve implantation (TAVI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Transfusion | Procedure | Blood Transfusion in patients who underwent transcatheter aortic valve implantation (TAVI) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiovascular events (MACE) | all-cause death, myocardial infarction (MI), stroke, or acute kidney injury (AKI) | 30 days and end of follow-up (3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Death | all-cause death, cardiovascular death, non cardiovascular death | 30 days and end of follow-up (3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial infarction | Myocardial infarction | 30 days and end of follow-up (3 years) |
| acute kidney injury (AKI) | need for dialYsis or increase in serum creatinine ≥0.3 mg/dL [≥26.4 μmol/L] or ≥50% increase ≤72 hours |
Inclusion Criteria:
Exclusion Criteria:
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All-consecutive patients referring at the participants centers undergoing transcatheter aortic valve implantation (TAVI)
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| Name | Affiliation | Role |
|---|---|---|
| Marco Zimarino, MD, PhD | G. d'Annunzio University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santissima Annunziata Hospital | Chieti | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29130845 | Result | Mazer CD, Whitlock RP, Fergusson DA, Hall J, Belley-Cote E, Connolly K, Khanykin B, Gregory AJ, de Medicis E, McGuinness S, Royse A, Carrier FM, Young PJ, Villar JC, Grocott HP, Seeberger MD, Fremes S, Lellouche F, Syed S, Byrne K, Bagshaw SM, Hwang NC, Mehta C, Painter TW, Royse C, Verma S, Hare GMT, Cohen A, Thorpe KE, Juni P, Shehata N; TRICS Investigators and Perioperative Anesthesia Clinical Trials Group. Restrictive or Liberal Red-Cell Transfusion for Cardiac Surgery. N Engl J Med. 2017 Nov 30;377(22):2133-2144. doi: 10.1056/NEJMoa1711818. Epub 2017 Nov 12. | |
| 30146969 |
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Data will be shared only to other Participants Centers
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001803 | Blood Transfusion |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| OTHER |
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| 30 days |
| stroke | stroke or transient ischemic attack (TIA) | 30 days and end of follow-up (3 years) |
| Result |
| Mazer CD, Whitlock RP, Fergusson DA, Belley-Cote E, Connolly K, Khanykin B, Gregory AJ, de Medicis E, Carrier FM, McGuinness S, Young PJ, Byrne K, Villar JC, Royse A, Grocott HP, Seeberger MD, Mehta C, Lellouche F, Hare GMT, Painter TW, Fremes S, Syed S, Bagshaw SM, Hwang NC, Royse C, Hall J, Dai D, Mistry N, Thorpe K, Verma S, Juni P, Shehata N; TRICS Investigators and Perioperative Anesthesia Clinical Trials Group. Six-Month Outcomes after Restrictive or Liberal Transfusion for Cardiac Surgery. N Engl J Med. 2018 Sep 27;379(13):1224-1233. doi: 10.1056/NEJMoa1808561. Epub 2018 Aug 26. |
| 42206788 | Derived | Pelliccia F, Pasceri V, Dangas G, Mehran R, Porto I, Radico F, Biancari F, D'Ascenzo F, Saia F, Luzi G, Bedogni F, Amat Santos IJ, De Marzo V, Dimagli A, Makikallio T, Stabile E, Blasco-Turrion S, Testa L, Barbanti M, Costa G, Fabbiocchi F, Chilmeran A, Stefanini G, Conrotto F, Tamburino C, Spaccarotella C, Cao D, Macchione A, La Torre M, Bendandi F, Wanha W, Wojakowski W, Benedetto U, Indolfi C, Hildick-Smith D, Capodanno D, Miraldi F, Dobrev D, Zimarino M; TRITAVI Study Group. Antiplatelet Therapy and All-Cause Mortality After Transcatheter Aortic Valve Replacement: The TRITAVI Registry. JACC Adv. 2026 May;5(5):102772. doi: 10.1016/j.jacadv.2026.102772. |
| 39070183 | Derived | Radico F, Biancari F, D'Ascenzo F, Saia F, Luzi G, Bedogni F, Amat-Santos IJ, De Marzo V, Dimagli A, Makikallio T, Stabile E, Blasco-Turrion S, Testa L, Barbanti M, Tamburino C, Porto I, Fabiocchi F, Conrotto F, Pelliccia F, Costa G, Stefanini GG, Macchione A, La Torre M, Bendandi F, Juvonen T, Pasceri V, Wanha W, Benedetto U, Miraldi F, Dobrev D, Zimarino M. Red blood cell transfusion and mortality after transcatheter aortic valve implantation via transapical approach: A propensity-matched comparison from the TRITAVI registry. Int J Cardiol Heart Vasc. 2024 Jul 6;53:101460. doi: 10.1016/j.ijcha.2024.101460. eCollection 2024 Aug. |
| 33272037 | Derived | Zimarino M, Barbanti M, Dangas GD, Testa L, Capodanno D, Stefanini GG, Radico F, Marchioni M, Amat-Santos I, Piva T, Saia F, Reimers B, De Innocentiis C, Picchi A, Toro A, Rodriguez-Gabella T, Nicolini E, Moretti C, Gallina S, Maddestra N, Bedogni F, Tamburino C. Early Adverse Impact of Transfusion After Transcatheter Aortic Valve Replacement: A Propensity-Matched Comparison From the TRITAVI Registry. Circ Cardiovasc Interv. 2020 Dec;13(12):e009026. doi: 10.1161/CIRCINTERVENTIONS.120.009026. Epub 2020 Dec 4. |
| D014694 |
| Ventricular Outflow Obstruction |