The valve-in-valve technique for treatment of aortic bioprosthesis malposition an analysis of incidence and 1-year clinical outcomes from the italian CoreValve registry

Objectives We appraised the incidence and clinical outcomes of patients who were treated with the valve-in-valve (VIV) technique for hemodynamically destabilizing paraprosthetic leak (PPL). Background Device malpositioning causing severe PPL after transcatheter aortic valve implantation is not an uncommon finding. It occurs after release of the prosthesis, leading to hemodynamic compromise. It can be managed successfully in selected cases with implantation of a second device inside the malpositioned primary prosthesis (VIV technique). Methods Consecutive patients (n = 663) who underwent transcatheter aortic valve implantation with the 18-F CoreValve ReValving System (Medtronic, Inc., Minneapolis, Minnesota) at 14 centers across Italy were included in this prospective web-based registry. We identified patients treated with the ViV technique for severe PPL and analyzed their clinical and echocardiographic outcomes. Primary end points were major adverse cerebrovascular and cardiac events and prosthesis performance at the 30-day and midterm follow-up. Results Overall procedural success was obtained in 650 patients (98.0%). The ViV technique was used in 24 (3.6%) of 663 patients. The 30-day major adverse cerebrovascular and cardiac event rates were 7.0% and 0% in patients undergoing the standard procedure and ViV technique, respectively (p = 0.185); the mortality rates were 5.6% versus 0% in patients undergoing the standard procedure and ViV technique, respectively (p = 0.238). There was an improvement in the mean transaortic gradient in all patients without significant difference between the 2 groups (from 52.1 +/- 17.1 mm Hg and 45.4 +/- 14.8 mm Hg [p = 0.060] to 10.1 +/- 4.2 mm Hg and 10.5 +/- 5.2 mm Hg, respectively [p = 0.838]). At 12 months, the major adverse cerebrovascular and cardiac event rates in the standard procedure and ViV technique groups were 4.5% and 14.1%, respectively (p = 0.158), and the mortality rates were 4.5% versus 13.7%, respectively (p = 0.230). Conclusions This large, multicenter registry provides important information about the feasibility, safety, and efficacy of the ViV technique with the third-generation CoreValve ReValving System. The clinical and echocardiographic end points compare favorably with those of patients undergoing the standard procedure. The ViV technique offers a viable therapeutic option in patients with acute significant PPL without recourse to emergent surgery. (J Am Coll Cardiol 2011; 57: 1062-8)