Ferrarotto Hospital, University of Catania, Catania, Italy.
J Am Coll Cardiol. 2011 Mar 1;57(9):1062-8. doi: 10.1016/j.jacc.2010.11.019.
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).
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).
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.
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).
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.
评估经瓣中瓣（ViV）技术治疗血流动力学不稳定瓣周漏（PPL）患者的发生率和临床结局。
经导管主动脉瓣置换术后因器械定位不当导致严重 PPL 并不少见。它发生在假体释放后，导致血流动力学受损。在选定的病例中，通过在错位的主假体内部植入第二个器械（ViV 技术）可以成功地进行治疗。
连续纳入在意大利 14 个中心进行经导管主动脉瓣置换术的 663 例患者（n=663），使用 18-F CoreValve ReValving 系统（美敦力公司，明尼苏达州明尼阿波利斯）。我们确定了接受 ViV 技术治疗严重 PPL 的患者，并分析了他们的临床和超声心动图结局。主要终点是 30 天和中期随访时的主要不良心脑血管事件和假体性能。
650 例患者（98.0%）获得了总体手术成功。663 例患者中，24 例（3.6%）接受了 ViV 技术治疗。标准手术组和 ViV 技术组的 30 天主要不良心脑血管事件发生率分别为 7.0%和 0%（p=0.185）；死亡率分别为 5.6%和 0%（p=0.238）。所有患者的平均跨主动脉梯度均有改善，两组之间无显著差异（从 52.1±17.1mmHg 和 45.4±14.8mmHg[分别为 p=0.060]至 10.1±4.2mmHg 和 10.5±5.2mmHg[分别为 p=0.838]）。12 个月时，标准手术组和 ViV 技术组的主要不良心脑血管事件发生率分别为 4.5%和 14.1%（p=0.158），死亡率分别为 4.5%和 13.7%（p=0.230）。
这项大型多中心注册研究提供了关于第三代 CoreValve ReValving 系统的 ViV 技术的可行性、安全性和疗效的重要信息。临床和超声心动图终点与接受标准手术的患者相比具有优势。ViV 技术为急性严重 PPL 患者提供了一种可行的治疗选择，而无需紧急手术。
