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2023年5月12日,香港伊利沙伯医院(QUEEN ELIZABETH HOSPITAL, QEH)由Dr. Michael Lee带领的结构心脏病团队成功应用JenaValve Trilogy为两例存在外科禁忌的症状性重度主动脉瓣反流患者完成了经导管主动脉瓣置换(TAVR),这也是JenaValve Trilogy系统在亚洲地区完成的首次植入。此次两例手术在香港的成功落地开展也预示着JenaValve Trilogy系统全球化应用进程的又一个里程碑!
手术案例简介
《2020 ACC/AHA瓣膜性心脏病患者管理指南》指出,由于主动脉瓣环和主动脉根部扩张,以及患者原生瓣叶钙化不足,采用传统TAVI器械存在瓣膜位移以及瓣周漏的风险,目前经导管主动脉瓣置换术(TAVI)治疗孤立性慢性主动脉瓣反流具有挑战性。
针对主动脉瓣狭窄设计TAVI器械的off-label应用,在临床实践中存在患者解剖的高选择性,以及对术者团队手术经验要求的严苛性,使得绝大多数这类患者未得到及时、有效治疗。如何针对主动脉瓣反流(AR)患者的解剖特点设计一款手术成功率更高、并发症更低,学习曲线更短的经股TAVI器械,成为亟待满足的临床需求。
自TAVR技术诞生及发展至今,AS目前仍是TAVR术式指南推荐的主要适应证。虽然TAVR术式的原理满足针对PAR患者进行假体植入的需要,这也催生了领域内众多off-label TAVR应用的尝试及相关经验的积累,但受制于PAR患者瓣叶无增厚及钙化、根部结构扩张等因素,瓣膜植入后存在的移位、继发反流、根部损伤等风险不容忽视。
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单纯反流解剖特点及传统TAVR挑战
此次接受手术的两位患者均被临床诊断为重度主动脉瓣反流且存在反流相关症状,患者因存在外科禁忌无法接受开胸换瓣,术前CT评估瓣叶无钙化呈现典型PAR解剖特点,经QEH结构心脏病及Peijia & JenaValve技术团队综合评估,患者适应证及解剖情况适宜并决定采用JenaValve Trilogy系统施行TAVR手术。
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Annulus 24.3 mm、LVOT-6 mm 24.6 mm、SOV:L33.3 mm × R 33.0mm × N34.3 mm、STJ 及升主动脉直径适中,根据测量结果适配Trilogy Size 25瓣膜。股髂入路血管内径及走行自然,主动脉少量钙化,弓部及瓣环水平夹角良好,升主动脉长度适宜。
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Annulus 22.0 mm、LVOT-6 mm 25.3 mm、SOV:L33.8 mm × R33.5 mm × N29.0 mm、STJ 及升主动脉直径适中,根据测量结果适配Trilogy Size 23瓣膜。股髂入路血管内径及走行自然,腹主存在偏曲,主动脉存在散在钙化,弓部及瓣环水平夹角良好,升主动脉长度适宜。
JenaValve Triology术中应用
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JenaValve Trilogy为自膨胀式经股动脉(TF)TAVR瓣膜系统,由猪心包瓣叶与镍钛合金骨架制成,区别于传统自膨胀瓣设计及释放方式,Trilogy瓣架上拥有三个锚定键(Locators),手术中锚定键会先于窦上水平展开,通过具有调轴对齐功能的输送器将锚定键对齐并下降至窦内,最终配合自膨胀瓣架展开形成主动锚定。JenaValve Trilogy特有的定位锚定及释放机制使其能够良好适应PAR解剖特点,2020年1月该系统获得 FDA 突破性器械称号,并于 2021 年 5 月 获得用于治疗主动脉瓣反流和主动脉瓣狭窄的CE认证成为全球首个获批AS+AR双适应证的TAVR瓣膜系统。
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根部造影呈现大量反流
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瓣膜输送至窦上水平锚定键展开
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调整锚定键与原生窦对齐
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造影确认—LCC
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造影确认—NCC
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造影确认—RCC
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瓣膜释放
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最终造影
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根部造影呈现大量反流
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瓣膜输送至窦上水平锚定键展开
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调整锚定键与原生窦对齐
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造影确认—LCC
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造影确认—NCC
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造影确认—RCC
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瓣膜释放
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最终造影
两例手术依据Trilogy标准手术流程进行,手术过程顺利,平均器械手术时长仅为25分钟( from sheath-in to sheath-out ),瓣膜植入即刻位置理想,仅轻度及以下瓣周漏,术后血流动力学显著改善。
小结
专家寄语
Dr. Michael Lee
Head of Cardiology, Consultant Cardiologist, Queen Elizabeth Hospital, Hong Kong SAR, China
The Trilogy Heart Valve System is a highly innovative therapeutical option licensed for both severe AR and severe AS patients. We are inspired that the Trilogy procedure is quite predictable due to its solid anchoring and the locator technology limiting the displacement, and the results of the first two cases of inoperable AR were successful and satisfying. These two AR cases are the first implantation with on-label TAVI transfemoral system in Asia. We do hope that Trilogy technique could save more patients who are suffering severe AR related disease in the future.
张一 博士
沛嘉医疗董事长兼CEO
此次与JenaValve合作,是继签署大中华区独家技术转让后,沛嘉医疗拓展商业化市场版图的重要里程碑。沛嘉医疗致力于通过前沿独特创新技术,服务更多临床中心,让更多创新治疗方案惠及结构性心脏病患者。沛嘉医疗将继续秉承至善尽心敬畏生命的宗旨,以国际化视野致力于打造本土医疗创新生态,推动瓣膜介入领域的创新器械和革命性疗法进一步落地。
John Kilcoyne
JenaValve CEO
We are clearly thrilled about the first commercial implants of the Trilogy Heart Valve System in Hong Kong SAR, China. This marked a major milestone accomplishment for the clinical use of Trilogy in Asia. We look forward to partnering with Peijia Medical and opinion leaders of Greater China to treat more severe, symptomatic aortic regurgitation patients in future.
Peter Spadaro
JenaValve CCO
The Trilogy Heart Valve offers a new option and more importantly an effective option for severe AR patients who historically had very few options for treatment. We are greatly encouraged by the first implants in Hong Kong and will be devoted to the future promotion of Trilogy in Asia. We are happy to see that the cooperation between Jenavalva and Peijia could provide operators with cutting-edge technology, which is aimed at improving the lives of our patients at the top speed.