Performance of Valve-in-Valve for Severe Para-Prosthetic Leaks due to Inadequate Transcatheter Aortic Valve Implantation Massimo Napodano, 1 * MD, Valeria Gasparetto, 1 MD, Giuseppe Tarantini, 1 MD, PHD, Chiara Fraccaro, 1 MD, Ermela Yzeiraj, 1 MD, Gino Gerosa, 2 MD, Giambattista Isabella, 1 MD, and Sabino Iliceto, 1 MD Objectives: This study reports on mid-term safety and performance of valve-in-valve implantation as rescue strategy to overcome acute PPL after TAVI. Background. Mod- erate to severe para-prosthetic leaks (PPL) after transcatheter aortic valve implantation (TAVI) have been described with both self-expandable and balloon-expandable device.- Methods: We analyzed data regarding patients who underwent valve-in-valve implanta- tion, enrolled in the ongoing single-center prospective registry of TAVI, the Padova Uni- versity REVALVing experience Registry. All procedures were performed by a totally per- cutaneous approach, using the self-expanding Medtronic CoreValve (Medtronic, Minneapolis, MN). Results: Out of 87 patients who underwent TAVI, six received valve- in-valve implantation because of persisting severe PPL, due to prosthesis malposition. In all patients, the second device was successfully deployed, with a significant reduc- tion in aortic regurgitation: PPL was no longer appreciable in two of six patients, and it decreased from severe to mild or trivial in four patients. Four patients developed atrio- ventricular block requiring pace-maker implantation. At follow-up (6–24 months) two patients died, whereas no prosthesis-related death occurred. Transprosthesis pressure gradient, effective orifice area, and aortic regurgitation did not change at serial echo- cardiograms throughout the follow-up. Conclusions: Valve-in-valve implantation using self-expandable bioprosthesis seems safe and highly effective to overcome severe PPL due to prosthesis malposition early after TAVI. Moreover, the implantation of two valves does not affect the performance of prosthesis at follow-up. V C 2011 Wiley Periodicals, Inc. Key words: aortic stenosis; bioprosthesis; para-prosthetic leak; trans-catheter aortic valve implantation INTRODUCTION Recently, the feasibility and the safety of transcatheter aortic valve implantation (TAVI) have been reported for the treatment of degenerative aortic valve stenosis. In particular, self-expandable and balloon-expandable devi- ces have been successfully implanted over the last years with different transcatheter techniques, using both retro- grade and antegrade femoral transluminal approach [1–5] or direct transapical puncture of the left ventricle [6,7]. However, despite the high rate of successful implantation, residual para-prosthetic leaks (PPL) of variable degree have been reported in many cases [1–7], primarily because of stent misdeployment in highly calcified stenotic valves, accounting for variables gaps at commissure level between the stent external surface and the inner surface of native valve [8]. In addition, device malpositioning such as ‘‘too high’’ or ‘‘too deep’’ implan- tation may also occur, leading to acute failure of biopros- thesis because of extensive leak between the aortic annu- lus and the prosthetic frames. Recently, Piazza et al. have reported on the feasibility and safety of two self-expand- ing bioprosthetic valve implantation during the same pro- cedure in a small series to treat the acute failure of TAVI 1 Division of Cardiology, Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Italy 2 Cardiac Surgery, Department of Cardiac, Thoracic and Vas- cular Sciences, University of Padova, Italy Conflict of interest: Nothing to report. *Correspondence to: Massimo Napodano, MD, Division of Cardiol- ogy, Department of Cardiac Thoracic and Vascular Sciences, Univer- sity of Padova, 2 via Giustiniani, 35100 Padova, Italy. E-mail: mas- simo.napodano@gmail.com Received 24 January 2011; Revision accepted 28 March 2011 DOI 10.1002/ccd.23181 Published online 5 October 2011 in Wiley Online Library (wileyonlinelibrary.com) V C 2011 Wiley Periodicals, Inc. Catheterization and Cardiovascular Interventions 78:996–1003 (2011)