Departments of General and Interventional Cardiology and Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany.
Departments of Cardiac Surgery and Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany.
JACC Cardiovasc Interv. 2014 Oct;7(10):1168-74. doi: 10.1016/j.jcin.2014.05.014. Epub 2014 Aug 13.
This analysis reports on the initial German multicenter experience with the JenaValve (JenaValve Technology GmbH, Munich, Germany) transcatheter heart valve for the treatment of pure aortic regurgitation.
Experience with transcatheter aortic valve implantation (TAVI) for severe aortic regurgitation is limited due to the risk of insufficient anchoring of the valve stent within the noncalcified aortic annulus.
Transapical TAVI with a JenaValve for the treatment of severe aortic regurgitation was performed in 31 patients (age 73.8 ± 9.1 years) in 9 German centers. All patients were considered high risk for surgery (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation] 23.6 ± 14.5%) according to a local heart team consensus. Procedural results and clinical outcomes up to 6 months were analyzed.
Implantation was successful in 30 of 31 cases (aortic annulus diameter 24.7 ± 1.5 mm); transcatheter heart valve dislodgement necessitated valve-in-valve implantation in 1 patient. Post-procedural aortic regurgitation was none/trace in 28 of 31 and mild in 3 of 31 patients. During follow-up, 2 patients underwent valvular reinterventions (surgical aortic valve replacement for endocarditis, valve-in-valve implantation for increasing paravalvular regurgitation). All-cause mortality was 12.9% and 19.3% at 30 days and 6 months, respectively. In the remaining patients, a significant improvement in New York Heart Association class was observed and persisted up to 6 months after TAVI.
Aortic regurgitation remains a challenging pathology for TAVI. After initial demonstration of feasibility, this multicenter study revealed the JenaValve transcatheter heart valve as a reasonable option in this subset of patients. However, a significant early noncardiac mortality related to the high-risk population emphasizes the need for careful patient selection.
本分析报告介绍了德国多中心使用 JenaValve（JenaValve Technology GmbH，慕尼黑，德国）经导管心脏瓣膜治疗单纯主动脉瓣反流的初步经验。
由于经导管主动脉瓣植入术（TAVI）治疗严重主动脉瓣反流的瓣膜支架在非钙化主动脉瓣环内锚定不足的风险，因此该领域的经验有限。
在德国 9 个中心，通过经心尖途径使用 JenaValve 对 31 例（年龄 73.8 ± 9.1 岁）严重主动脉瓣反流患者进行 TAVI。所有患者根据当地心脏团队的共识，均被认为具有手术高风险（Logistic EuroSCORE[欧洲心脏手术风险评估系统]23.6 ± 14.5%）。分析了 6 个月内的手术结果和临床结果。
31 例患者中有 30 例（主动脉瓣环直径 24.7 ± 1.5 mm）成功植入；1 例患者因经导管心脏瓣膜移位而需要植入瓣膜内瓣。31 例患者中有 28 例术后主动脉瓣反流为无/微量，3 例为轻度。随访期间，2 例患者进行了瓣膜再介入（感染性心内膜炎行外科主动脉瓣置换术，瓣中瓣植入术治疗瓣周反流增加）。30 天和 6 个月时全因死亡率分别为 12.9%和 19.3%。在其余患者中，观察到纽约心脏协会（NYHA）心功能分级显著改善，并持续至 TAVI 后 6 个月。
主动脉瓣反流仍是 TAVI 的一项具有挑战性的病理。在最初证明可行性后，这项多中心研究表明，JenaValve 经导管心脏瓣膜是该患者群体的合理选择。然而，与高危人群相关的早期非心脏死亡率较高强调了需要仔细选择患者。
