CoreValve Italian Registry Finds Valve-in-Valve Technique Viable for Treatment of Aortic Bioprosthesis Malposition

February 22, 2011—In the Journal of the American College of Cardiology, Gian Paolo Ussia, MD, et al published an analysis of incidence and 1-year clinical outcomes from the Italian CoreValve registry (2011;57:1062). The investigators sought to appraise the incidence and clinical outcomes of patients who were treated with the valve-in-valve (ViV) technique for hemodynamically destabilizing paraprosthetic leak (PPL).

As reported in Cardiac Interventions Today on January 18, 2011, the Italian CoreValve registry's findings on the incidence and predictors of early and late mortality after transcatheter aortic valve implantation (TAVI) with the CoreValve ReValving system (Medtronic, Inc., Minneapolis, MN) in 663 patients with severe aortic stenosis have been published in Circulation (2011;123:299–308). In the earlier study, the investigators concluded that the benefit of TAVI with the CoreValve ReValving system is maintained over time up to 1 year, with acceptable mortality rates at various time points.

According to the investigators, the background of the ViV analysis is that device malpositioning causing severe PPL after TAVI 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 the ViV technique: implanting a second device inside the malpositioned primary prosthesis.

As detailed in the Journal of the American College of Cardiology, consecutive patients (n = 663) who underwent TAVI with the 18-F CoreValve ReValving system at 14 centers in Italy were included in this prospective Web-based registry. The investigators identified patients treated with the ViV technique for severe PPL and analyzed their clinical and echocardiographic outcomes. Primary endpoints were major adverse cerebrovascular and cardiac events (MACCE) and prosthesis performance at 30-day and midterm follow-up.

The investigators reported that overall procedural success was obtained in 650 patients (98%). The ViV technique was used in 24 (3.6%) of 663 patients. The 30-day MACCE rates were 7% and 0% in patients undergoing the standard procedure and ViV technique, respectively (P = .185). The mortality rates were 5.6% versus 0% in patients undergoing the standard procedure and ViV technique, respectively (P = .238).

There was an improvement in the mean transaortic gradient in all patients without significant difference between the two groups (from 52.1 ± 17.1 mm Hg and 45.4 ± 14.8 mm Hg [P = .060] to 10.1 ± 4.2 mm Hg and 10.5 ± 5.2 mm Hg, respectively [P = .838]). At 12 months, the MACCE rates in the standard procedure and ViV technique groups were 4.5% and 14.1%, respectively (P = .158), and the mortality rates were 4.5% versus 13.7%, respectively (P = .23).

According to the investigators, 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 endpoints 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, concluded the investigators.