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经导管肺动脉瓣置换术(Edwards Sapien 3 瓣膜)的中期结果——德国经验。

Intermediate outcomes of transcatheter pulmonary valve replacement with the Edwards Sapien 3 valve - German experience.

机构信息

Department for Pediatric Cardiology and Intensive Care, Medical Hospital of the University of Munich, LMU Ludwig Maximilians University Munich , Munich , Germany.

Department for Pediatric Cardiology and Intensive Care, Heart Center Goettingen, Georg-August-University Goettingen , Goettingen , Germany.

出版信息

Expert Rev Med Devices. 2019 Sep;16(9):829-834. doi: 10.1080/17434440.2019.1653180. Epub 2019 Aug 30.

Abstract

: After encouraging results with the Edwards Sapien and XT valves, this study aimed to review procedural data and early outcomes for the Sapien 3 valves for transcatheter pulmonary valve replacement (TPVR). : We performed a multicenter, retrospective analysis of cases who underwent a Sapien 3 TPVR between 2015 and 2017 in 7 centers in Germany with a follow-up of up to 2 years. : 56 patients could be enrolled (weight 58,5 ± 25,0 kg; 53% Tetralogy of Fallot, 45% native RVOT). Most procedures were two-stage procedures (82,1%) with 100% prestenting. Valve sizes were 20 mm (n = 1), 23 mm (n = 15), 26 mm (n = 27), 29 mm (n = 13). Procedural success rate was 96.4%. Two patients underwent surgical valve implantation after balloon rupture during TPVR. Follow-up data were available up to 24-month post TPVR. The rate of patients with ? moderate and severe pulmonary regurgitation decreased to 0% after TPVR, peak systolic gradient decreased from 24,2 (SD±20,9) mmHg to 7,1 mmHg (SD±5,0). There were no endocarditis, severe tricuspid valve impairment or stent fractures. : With the Edwards Sapien 3 valve, the patient pool for TPVR can be substantially extended. Continued data collection is necessary to verify long-term results.

摘要

在 Edwards Sapien 和 XT 瓣膜取得令人鼓舞的结果后,本研究旨在回顾经导管肺动脉瓣置换术(TPVR)中 Sapien 3 瓣膜的手术数据和早期结果。

我们对 2015 年至 2017 年期间在德国 7 个中心进行的 56 例 Sapien 3 TPVR 患者进行了多中心回顾性分析,随访时间长达 2 年。患者体重 58.5±25.0kg,53%为法洛四联症,45%为原发性右室流出道病变。大多数手术为两阶段手术(82.1%),100%预扩张。瓣膜尺寸为 20mm(n=1)、23mm(n=15)、26mm(n=27)、29mm(n=13)。手术成功率为 96.4%。2 例患者在 TPVR 期间球囊破裂后接受了外科瓣膜植入。TPVR 后至 24 个月的随访数据可用。TPVR 后,中度和重度肺动脉瓣反流的患者比例降至 0%,收缩期峰值梯度从 24.2mmHg(SD±20.9mmHg)降至 7.1mmHg(SD±5.0mmHg)。无感染性心内膜炎、严重三尖瓣损害或支架断裂。

使用 Edwards Sapien 3 瓣膜,TPVR 的患者人群可以得到实质性扩展。需要进一步收集数据来验证长期结果。

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