Incidence, Predictors, and Mid-Term Outcomes of Percutaneous Closure Failure After Transfemoral Aortic Valve Implantation Using an Expandable Sheath (from the Optimized Transcatheter Valvular Intervention [OCEAN-TAVI] Registry)

The authors report on their findings an ongoing Japanese multicentre prospective registry. They evaluate outcomes in 478 patients undergoing transfemoral  TAVI and treated with percutaneous puncture using an expandable sheath, Edwards Sapien XTprosthesis and a Perclose ProGlide system. The primary outcome was percutaneous closure device (PCD) failure. The secondary outcome was the relation between PCD failure and the clinical outcomes (30-day and mid-term mortality rates and the length of hospital stay). PCD failures occurred in 36 patients (8%) and were not associated with the 30-day or the mid-term mortality rates. PCD failures can be predicted by the sheath-to-femoral artery ratio (SFAR). An SFAR threshold of ≥ 1.03 is the recommended cut-off point when PCD and an eSheath are used. Thus, this cut-off value may contribute to the selection of the sheath size, vascular access site, and method of approach.