Division of Cardiology, Department of Pediatrics, Washington University School of Medicine, St. Louis, Missouri, USA.
Guerin Family Congenital Heart Program, The Heart Institute and Department of Pediatrics Cedars-Sinai Medical Center, Los Angeles, California, USA.
J Am Coll Cardiol. 2020 Dec 15;76(24):2847-2858. doi: 10.1016/j.jacc.2020.10.041.
There are limited published data focused on outcomes of transcatheter pulmonary valve replacement (TPVR) with either a Sapien XT or Sapien 3 (S3) valve.
This study sought to report short-term outcomes in a large cohort of patients who underwent TPVR with either a Sapien XT or S3 valve.
Data were entered retrospectively into a multicenter registry for patients who underwent attempted TPVR with a Sapien XT or S3 valve. Patient-related, procedural, and short-term outcomes data were characterized overall and according to type of right ventricular outflow tract (RVOT) anatomy.
Twenty-three centers enrolled a total of 774 patients: 397 (51%) with a native/patched RVOT; 183 (24%) with a conduit; and 194 (25%) with a bioprosthetic valve. The S3 was used in 78% of patients, and the XT was used in 22%, with most patients receiving a 29-mm (39%) or 26-mm (34%) valve. The implant was technically successful in 754 (97.4%) patients. Serious adverse events were reported in 67 patients (10%), with no difference between RVOT anatomy groups. Fourteen patients underwent urgent surgery. Nine patients had a second valve implanted. Among patients with available data, tricuspid valve injury was documented in 11 (1.7%), and 9 others (1.3%) had new moderate or severe regurgitation 2 grades higher than pre-implantation, for 20 (3.0%) total patients with tricuspid valve complications. Valve function at discharge was excellent in most patients, but 58 (8.5%) had moderate or greater pulmonary regurgitation or maximum Doppler gradients >40 mm Hg. During limited follow-up (n = 349; median: 12 months), 9 patients were diagnosed with endocarditis, and 17 additional patients underwent surgical valve replacement or valve-in-valve TPVR.
Acute outcomes after TPVR with balloon-expandable valves were generally excellent in all types of RVOT. Additional data and longer follow-up will be necessary to gain insight into these issues.
目前，有关经导管肺动脉瓣置换术（TPVR）中使用 Sapien XT 或 Sapien 3（S3）瓣膜的研究结果数据十分有限。
本研究旨在报告大量接受 Sapien XT 或 S3 瓣膜行 TPVR 治疗的患者的短期结果。
将接受 Sapien XT 或 S3 瓣膜行 TPVR 治疗的患者数据回顾性地输入多中心登记处。对患者相关、手术相关和短期结局数据进行了总体分析，并根据右心室流出道（RVOT）解剖结构的类型进行了分类。
23 家中心共纳入 774 例患者：397 例（51%）患者存在原发性/修补 RVOT；183 例（24%）患者存在RVOT 移植物；194 例（25%）患者存在生物瓣。78%的患者使用了 S3 瓣膜，22%的患者使用了 XT 瓣膜，大多数患者植入的瓣膜尺寸为 29-mm（39%）或 26-mm（34%）。754 例（97.4%）患者的植入术技术成功。67 例（10%）患者发生严重不良事件，各组 RVOT 解剖结构之间无差异。14 例患者紧急手术，9 例患者再次植入瓣膜。在有可用数据的患者中，11 例（1.7%）患者出现三尖瓣损伤，9 例（1.3%）患者的瓣中瓣植入前存在中度或重度反流，反流程度增加 2 级，总共有 20 例（3.0%）患者发生三尖瓣并发症。大多数患者出院时的瓣膜功能良好，但 58 例（8.5%）患者存在中度或重度肺动脉瓣反流或最大多普勒梯度＞40mmHg。在有限的随访期间（n=349；中位随访时间：12 个月），9 例患者被诊断为感染性心内膜炎，17 例患者再次接受了外科瓣膜置换或瓣中瓣 TPVR 治疗。
所有类型的 RVOT 行球囊扩张型瓣膜 TPVR 的急性结果通常都很好。需要进一步的随访和更长时间的随访来深入了解这些问题。
