Aortic Valve Disease
Conditions
Keywords
VinV TAVI, Trifecta valve, Epic valve
Brief summary
Non-randomized, open label, non-interventional, multicenter registry to describe risk factors, management strategies, and clinical outcomes in patients undergoing Valve in Valve (ViV) transcatheter aortic valve implantation (TAVI) in a previously implanted Trifecta or Epic valve using retrospective registry data from large volume centers
Detailed description
Anonymized pre-, intra-, and postoperative data will be collected from patients undergoing VinV TAVI in a previously implanted Trifecta™ valve, Trifecta™ GT, Epic™ or Epic™ Supra valve from the largest volume implanters of the Trifecta and Epic valve in Europe until June 2020. The data will be analyzed in order to give a comprehensive description of clinical outcomes for Trifecta VinV procedures, to identify preoperative risk factors for coronary obstruction, 30-day and 1-year mortality, and other major complications, and to analyze the effects of patient characteristics and / or protective maneuvers in order to prevent coronary obstruction. Differences of Trifecta and Epic failed patients will also be analyzed.
Interventions
OTHERno intervention
no intervention
Sponsors
Abbott
Helios Health Institute GmbH
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients who underwent a TAVI VinV procedure post-Trifecta or Epic implantation * Patients who underwent planned or unplanned concomitant percutaneous coronary intervention (PCI) during the index hospital admission will be included, as will those undergoing emergent conventional cardiac surgery.
Exclusion criteria
* 1\. TAVI VinV post-implantation of an aortic valve bioprosthesis other than the Trifecta or Epic valve * 2\. Patients undergoing combined, multiple transcatheter valve procedures in addition to TAVI VinV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| composite endpoint of 30-day all-cause mortality and/or unplanned coronary obstruction | 30 days | coronary obstruction defined as (1) coronary obstruction resulting in myocardial infarction and/or cardiogenic shock, or (2) coronary obstruction requiring emergent coronary intervention with or without pre-TAVI coronary protection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| freedom from other major Valve Academic Research Consortium 2 (VARC2) complications | day of discharge from hospital after receiving VinV TAVI or 30 days, whichever is earlier | — |
| freedom from other major VARC2 complications | 1 year | — |
| all-cause mortality | 30-days | — |
| freedom from each individual Major Adverse Cardiac Event endpoint | day of discharge from hospital after receiving VinV TAVI or 30 days, whichever is earlier | — |
| freedom from Major Adverse Cardiac Events defined as death, myocardial infarction or stroke | day of discharge from hospital after receiving VinV TAVI or 30 days, whichever is earlier | — |
| post-VinV hemodynamic performance including transvalvular gradient, effective orifice area and paravalvular leak rate | day of discharge from hospital after receiving VinV TAVI or 30 days, whichever is earlier | — |
| patients with unplanned coronary obstruction | 30-days | coronary obstruction defined as (1) coronary obstruction resulting in myocardial infarction and/or cardiogenic shock, or (2) coronary obstruction requiring emergent coronary intervention with or without pre-TAVI coronary protection. |
Countries
Belgium, Germany, Netherlands
Outcome results
None listed