Smolka Grzegorz, Pysz Piotr, Jasiński Marek, Roleder Tomasz, Peszek-Przybyła Ewa, Ochała Andrzej, Wojakowski Wojciech
3rd Division of Cardiology, Medical University of Silesia, Katowice, Poland.
Division of Cardiology, Medical University of Silesia, Katowice, Poland.
Catheter Cardiovasc Interv. 2016 Feb 15;87(3):478-87. doi: 10.1002/ccd.25992. Epub 2015 May 11.
Transcatheter paravalvular leak closure (TPVLC) offers a viable alternative to reoperation but optimal technical strategy is still to be defined. We present a prospective TPVLC registry in which safety and efficacy of multi-plug, single-stage approach were assessed.
Patients with heart failure (HF) symptoms caused by PVL were qualified for TPVLC by Heart Team. Ante- or retrograde access was employed for mitral while retrograde only for aortic PVLs. Two to 4 AVP 3 devices were simultaneously implanted into each PVL. Endpoints were defined according to VARC-2.
From 64 referred patients 49, with either mechanical valves (n = 30) or stented bioprostheses, were eligible for TPVLC. PVL location was mitral (n = 29) or aortic (n = 20). In aortic group acute procedural success (APS) ratio was 100% and no MACCEs occurred. In mitral group, first-attempt TPVLC was successful in 22 cases (4/4 in transapical and 18/25 in transseptal access). Second-attempt transapical procedure followed transseptal failure in 5 patients. Mitral TPVLC ultimately proved efficient in 89.7% with 76.5% APS. Cumulatively, TPVLC was accomplished in 46 subjects (93.9%) with 78% APS. When successful, it led to a significant decrease of NT-proBNP concentration and HF symptoms regression. Periprocedural safety endpoints were met in three patients and included non-disabling stroke, and two access site-related complications. In device failure group two patients died (end-stage HF) and two others were rehospitalized.
TPVLC with simultaneous deployment of multiple AVP III occluders is feasible with high device success rate and no significant periprocedural complications. The clinical benefits of reduction of HF symptoms and hemolysis are evident after 30 days and persist up to 1 year without recurrence of PVL.
经导管瓣周漏封堵术（TPVLC）为再次手术提供了一种可行的替代方案，但最佳技术策略仍有待确定。我们开展了一项前瞻性TPVLC注册研究，评估了多封堵器单阶段方法的安全性和有效性。
由心脏团队确定因瓣周漏导致心力衰竭（HF）症状的患者适合进行TPVLC。二尖瓣瓣周漏采用顺行或逆行入路，而主动脉瓣周漏仅采用逆行入路。每个瓣周漏同时植入2至4个AVP 3装置。终点根据VARC-2定义。
在64例转诊患者中，49例（机械瓣膜患者30例，带支架生物瓣膜患者）符合TPVLC条件。瓣周漏位置为二尖瓣（29例）或主动脉瓣（20例）。在主动脉瓣组中，急性手术成功率（APS）为100%，未发生主要不良心血管和脑血管事件（MACCE）。在二尖瓣组中，首次尝试TPVLC成功22例（经心尖入路4/4例，经房间隔入路18/25例）。5例患者在经房间隔入路失败后进行了第二次经心尖手术。二尖瓣TPVLC最终证明有效率为89.7%，APS为76.5%。累计46例患者（93.9%）完成了TPVLC，APS为78%。成功后，NT-proBNP浓度显著降低，HF症状缓解。3例患者达到围手术期安全终点，包括非致残性卒中及2例与入路部位相关的并发症。在器械失败组中，2例患者死亡（终末期HF），另外2例再次住院。
同时部署多个AVP III封堵器进行TPVLC是可行的，器械成功率高，围手术期无明显并发症。HF症状减轻和溶血减少的临床益处30天后明显，可持续至1年，瓣周漏无复发。
