Trifecta and Epic ViV Detailed Insights Into Management Strategies and Outcomes

The International Trifecta and Epic Valve-in-Valve Registry: Detailed Insights Into Management Strategies and Outcomes

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

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.

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