Self‐expanding transcatheter aortic valve infolding: Current evidence, diagnosis, and management

Background Prosthetic valve infolding is a rare but severe complication of transcatheter aortic valve implantation (TAVI) with self‐expanding valves. However, currently available clinical data are limited and fragmented. Objectives This report aims to provide a comprehensive overview of this complication focusing on predisposing factors, clinical presentation, diagnostic findings, treatment and clinical outcomes. Methods A systematic review of the literature was performed to identify cases of infolding occurring during TAVI with self‐expanding valves published until August 2020. These data were pooled with all the retrospectively identified infolding cases occurred at San Raffaele Scientific Institute between December 2014 and August 2020. Results A total of 34 cases were included. Among patients with available data, 38% received a first‐generation CoreValve, and 62% a second‐generation Evolut R (82%) or Evolut PRO (18%). Infolding occurred mostly with ≥29‐mm valves (94%). Predisposing factors included resheathing of a second‐generation valve (82%), heavy calcification of the native valve (65%), lack of predilatation (16%), Sievers type‐1 bicuspid aortic valve (11%), and improper valve loading (5%). Infolding resulted in severe PVL causing hemodynamic instability (29%) or cardiac arrest (12%). Postdilatation was the treatment strategy in 68%, while prosthesis replacement with a new device in 23% of cases. Device success rate was 82%. Death and stroke occurred in 3% and 12% of cases. Conclusions Prosthetic valve infolding is typically observed after resheathing of a large‐size self‐expanding TAVI. When infolding is timely diagnosed, prosthesis removal and replacement should be pursued. Further studies are required to precisely define predisposing factors to prevent this complication.