BACKGROUND There are limited published data focused on outcomes of transcatheter pulmonary valve replacement (TPVR) with either a Sapien XT or Sapien 3 (S3) valve. OBJECTIVES 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. METHODS 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. RESULTS 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. CONCLUSIONS 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.

中文翻译：

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用 Sapien 假体置换经导管肺动脉瓣

背景 发表的关于 Sapien XT 或 Sapien 3 (S3) 瓣膜经导管肺动脉瓣置换术 (TPVR) 结果的数据有限。目的 本研究旨在报告大量接受 Sapien XT 或 S3 瓣膜 TPVR 患者的短期结果。方法 对接受 Sapien XT 或 S3 瓣膜尝试 TPVR 的患者的数据进行回顾性输入多中心注册。根据右心室流出道 (RVOT) 解剖结构的类型，对患者相关、程序和短期结果数据进行了总体表征。结果 23 个中心共招募了 774 名患者：397 名 (51%) 具有天然/修补 RVOT；183 (24%) 有导管；194 (25%) 名使用生物瓣膜。78% 的患者使用了 S3，22% 的患者使用了 XT，大多数患者接受 29 毫米 (39%) 或 26 毫米 (34%) 瓣膜。该植入物在 754 (97.4%) 名患者中在技术上取得了成功。67 名患者 (10%) 报告了严重不良事件，RVOT 解剖组之间没有差异。14 名患者接受了紧急手术。九名患者植入了第二个瓣膜。在有可用数据的患者中，11 名 (1.7%) 记录了三尖瓣损伤，另外 9 名 (1.3%) 出现了比植入前高 2 级的新中度或重度反流，总共 20 名 (3.0%) 三尖瓣患者并发症。大多数患者出院时瓣膜功能良好，但 58 例 (8.5%) 有中度或以上肺动脉瓣反流或最大多普勒梯度 >40 mmHg。在有限的随访期间（n = 349；中位数：12 个月），9 名患者被诊断为心内膜炎，另有 17 名患者接受了外科瓣膜置换术或瓣中瓣 TPVR。结论 在所有类型的 RVOT 中，采用球囊扩张瓣膜的 TPVR 后的急性结果通常都非常好。需要额外的数据和更长时间的随访才能深入了解这些问题。