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.