Ielasi Alfonso, Caminiti Rodolfo, Giordano Arturo, Holzamer Andreas, Vetta Giampaolo, Testa Luca, Farkic Mihajlo, Stoyanov Nikolay, Gallo Francesco, Azzano Alessia, Leick Juergen, De Marco Federico, Kovacevic Mila, Tigges Eike, Protasiewicz Marcin, Immè Sebastiano, Mangieri Antonio, Tespili Maurizio
IRCCS Ospedale Galeazzi Sant'Ambrogio, Milan, Italy.
Cardiovascular Interventional Unit, Pineta Grande Hospital, Castel Volturno, Italy.
Catheter Cardiovasc Interv. 2025 Jul;106(1):511-520. doi: 10.1002/ccd.31563. Epub 2025 May 5.
THV is a standard treatment for elderly patients with severe AS, using either BE or self-expanding (SE) THVs. While the Myval BE THV has demonstrated safety and efficacy, data on its latest iteration, the Octacor, are limited.
To evaluate the clinical performance of the next-generation Myval Octacor balloon-expandable (BE) transcatheter heart valve (THV) in patients with severe, symptomatic native aortic valve stenosis (AS).
This observational, real-world, multicenter study involved patients deemed suitable for TAVR and treated with Octacor BE THV at 15 European centers. The primary endpoint was the rate of technical success (exit from procedure room) per VARC-3 criteria. Secondary endpoints included overall mortality, stroke, moderate-to-severe paravalvular leak (PVL), and need for permanent pacemaker (pPM) at 30-day and the longest available follow-up. An analysis by THV sizes (standard -20 to 29 mm vs. XL sizes -30.5 and 32 mm) was performed.
From January to December 2023, 252 patients with severe AS underwent TAVR with the Octacor THV. The average age was 80.6 ± 6.7 years, and the mean STS score was 3.45%. Bicuspid anatomy was reported in 7.1% of cases (standard group 5.4% vs. XL group 20%, p = 0.004). Technical success was achieved in 98.8% of procedures (standard group 99.1% vs. XL group 96.7%, p = 0.2). At 30 days, overall mortality was 1.2%, stroke 3.2%, moderate-to-severe PVL 0.8%, and pPM 16.3%.
The novel BE Myval Octacor THV showed high technical success and favorable early clinical outcomes. Longer follow-up and a head-to-head comparison versus other commercially available THVs are awaited.
经导管心脏瓣膜（THV）是老年重度主动脉瓣狭窄（AS）患者的标准治疗方法，可使用球囊扩张式（BE）或自膨胀式（SE）THV。虽然Myval BE THV已证明其安全性和有效性，但其最新版本Octacor的数据有限。
评估新一代Myval Octacor球囊扩张式（BE）经导管心脏瓣膜（THV）在重度、有症状的原发性主动脉瓣狭窄（AS）患者中的临床性能。
这项观察性、真实世界、多中心研究纳入了15个欧洲中心认为适合经导管主动脉瓣置换术（TAVR）并接受Octacor BE THV治疗的患者。主要终点是根据VARC-3标准的技术成功率（离开手术室）。次要终点包括30天及最长可用随访期的全因死亡率、中风、中重度瓣周漏（PVL）以及永久起搏器（pPM）植入需求。对THV尺寸进行了分析（标准尺寸20至29毫米与超大尺寸30.5和32毫米）。
2023年1月至12月，252例重度AS患者接受了Octacor THV的TAVR治疗。平均年龄为80.6±6.7岁，平均胸外科医师协会（STS）评分3.45%。7.1%的病例报告为二叶式解剖结构（标准组5.4%，超大尺寸组20%，p = 0.004）。98.8%的手术取得技术成功（标准组99.1%，超大尺寸组96.7%，p = 0.2）。30天时，全因死亡率为1.2%，中风为3.2%，中重度PVL为0.8%，pPM植入率为16.3%。
新型BE Myval Octacor THV显示出较高的技术成功率和良好的早期临床结果。有待更长时间的随访以及与其他商用THV进行直接对比。
