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Compassionate Use of the PASCAL Transcatheter Valve Repair System for Severe Tricuspid Regurgitation: A Multicenter, Observational, First-in-Human Experience.
JACC: Cardiovascular Interventions ( IF 11.7 ) Pub Date : 2019-12-23 , DOI: 10.1016/j.jcin.2019.09.046 Neil P Fam 1 , Daniel Braun 2 , Ralph Stephan von Bardeleben 3 , Michael Nabauer 2 , Tobias Ruf 3 , Kim A Connelly 1 , Edwin Ho 1 , Holger Thiele 4 , Philipp Lurz 4 , Marcel Weber 5 , Georg Nickenig 5 , Akhil Narang 6 , Charles J Davidson 6 , Jörg Hausleiter 2
JACC: Cardiovascular Interventions ( IF 11.7 ) Pub Date : 2019-12-23 , DOI: 10.1016/j.jcin.2019.09.046 Neil P Fam 1 , Daniel Braun 2 , Ralph Stephan von Bardeleben 3 , Michael Nabauer 2 , Tobias Ruf 3 , Kim A Connelly 1 , Edwin Ho 1 , Holger Thiele 4 , Philipp Lurz 4 , Marcel Weber 5 , Georg Nickenig 5 , Akhil Narang 6 , Charles J Davidson 6 , Jörg Hausleiter 2
Affiliation
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OBJECTIVES
The purpose of this observational first-in-human experience was to investigate the feasibility and safety of the PASCAL transcatheter valve repair system and its impact on short-term clinical outcomes in patients with severe tricuspid regurgitation (TR).
BACKGROUND
Transcatheter repair of severe TR is a promising treatment option for patients at prohibitive surgical risk. Large leaflet coaptation gaps and tethering represent common features that challenge the application of transcatheter repair techniques.
METHODS
Twenty-eight patients with severe TR were treated with the PASCAL system in a compassionate use experience at 6 sites. All patients had heart failure due to severe TR and were deemed at high surgical risk by institutional heart teams. The primary outcome was procedural success, defined as the implantation of at least 1 device with post-procedural TR grade ≤2+, without mortality or conversion to surgery.
RESULTS
All patients (mean age 78 ± 6 years, 54% women) were at high surgical risk (mean European System for Cardiac Operative Risk Evaluation II score 6.2 ± 5.2%). TR etiology was functional in 92%, with mean tricuspid annular diameter of 49.5 ± 6 mm and mean coaptation gap of 6.9 ± 3 mm. Procedural success was 86%, with 1.4 ± 0.6 devices implanted per patient. There were no intraprocedural complications. At 30-day follow-up, mortality was 7.1%, 88% of patients were in New York Heart Association functional class I or II, with TR grade ≤2+ in 85%. There were 2 single-leaflet device attachments, which were managed conservatively. Six-min walk distance improved from 240 m (interquartile range: 172 to 337 m) to 335 m (interquartile range: 251 to 385 m) (p < 0.001).
CONCLUSIONS
This first-in-human experience evaluating transcatheter tricuspid repair with the PASCAL system demonstrated high procedural success, acceptable safety, and significant clinical improvement. Larger prospective studies with long-term follow-up are needed to confirm these initial promising results and further define the impact of PASCAL tricuspid repair on clinical outcomes.
中文翻译：
广泛使用PASCAL经导管瓣膜修复系统治疗严重三尖瓣关闭不全：多中心，观察性的，亲身的体验。
目的本人的观察性首次观察目的旨在研究PASCAL导管瓣膜修复系统的可行性和安全性及其对重度三尖瓣关闭不全（TR）患者短期临床预后的影响。背景技术对于具有高手术风险的患者，经导管修复重度TR是一种有前途的治疗选择。大的小叶接合间隙和系留代表了挑战经导管修复技术应用的共同特征。方法采用PASCAL系统在6个部位进行了富有同情心的使用经验，对28例重度TR患者进行了治疗。所有患者均因严重的TR而出现心力衰竭，并被机构心脏小组认为处于高手术风险中。主要结果是程序上的成功，定义为植入至少1台手术后TR≤2+的装置，且无死亡或无需手术。结果所有患者（平均年龄为78±6岁，女性为54％）均处于高手术风险中（欧洲心脏手术风险评估系统平均II级评分为6.2±5.2％）。TR病因学在92％的患者中起作用，三尖瓣环的平均直径为49.5±6 mm，平均接合间隙为6.9±3 mm。手术成功率为86％，每位患者植入1.4±0.6装置。没有手术中并发症。在30天的随访中，死亡率为7.1％，纽约心脏协会功能I级或II级患者为88％，TR≤2+的患者为85％。有2个单叶设备附件，这些附件是经过保守管理的。步行6分钟的距离从240 m（四分位间距：172至337 m）至335 m（四分位间距：251至385 m）（p <0.001）。结论这项使用PASCAL系统评估经导管三尖瓣修复的亲身经验表明，该方法具有很高的手术成功率，可接受的安全性和显着的临床改善。需要更大范围的前瞻性研究并进行长期随访，以确认这些最初的有希望的结果，并进一步确定PASCAL三尖瓣修复对临床结果的影响。
更新日期：2019-12-16
中文翻译：
广泛使用PASCAL经导管瓣膜修复系统治疗严重三尖瓣关闭不全：多中心，观察性的，亲身的体验。
目的本人的观察性首次观察目的旨在研究PASCAL导管瓣膜修复系统的可行性和安全性及其对重度三尖瓣关闭不全（TR）患者短期临床预后的影响。背景技术对于具有高手术风险的患者，经导管修复重度TR是一种有前途的治疗选择。大的小叶接合间隙和系留代表了挑战经导管修复技术应用的共同特征。方法采用PASCAL系统在6个部位进行了富有同情心的使用经验，对28例重度TR患者进行了治疗。所有患者均因严重的TR而出现心力衰竭，并被机构心脏小组认为处于高手术风险中。主要结果是程序上的成功，定义为植入至少1台手术后TR≤2+的装置，且无死亡或无需手术。结果所有患者（平均年龄为78±6岁，女性为54％）均处于高手术风险中（欧洲心脏手术风险评估系统平均II级评分为6.2±5.2％）。TR病因学在92％的患者中起作用，三尖瓣环的平均直径为49.5±6 mm，平均接合间隙为6.9±3 mm。手术成功率为86％，每位患者植入1.4±0.6装置。没有手术中并发症。在30天的随访中，死亡率为7.1％，纽约心脏协会功能I级或II级患者为88％，TR≤2+的患者为85％。有2个单叶设备附件，这些附件是经过保守管理的。步行6分钟的距离从240 m（四分位间距：172至337 m）至335 m（四分位间距：251至385 m）（p <0.001）。结论这项使用PASCAL系统评估经导管三尖瓣修复的亲身经验表明，该方法具有很高的手术成功率，可接受的安全性和显着的临床改善。需要更大范围的前瞻性研究并进行长期随访，以确认这些最初的有希望的结果，并进一步确定PASCAL三尖瓣修复对临床结果的影响。
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