Jan M Wrobel, Johannes Kirchner, Kai Friedrichs, Thorsten Gietzen, Jan Althoff, Caroline Hasse, Philipp von Stein, Jonas Wörmann, Jennifer von Stein, Jonathan Curio, Felix Rudolph, Maria Ivannikova, Christos Iliadis, Daniel Steven, Stephan Baldus, Volker Rudolph, Roman Pfister, Muhammed Gerçek, Maria I Koerber
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Patients were divided into CIED carriers and non-CIED carriers. CIED carriers were further classified into those with lead-associated TR (LTR-A) and those with TR unrelated to CIED leads (LTR-B).</p><p><strong>Results: </strong>Among the 204 patients, 41 (20%) were CIED carriers. Of these, 24% had mixed TR etiology (functional and LTR-A), while 76% had predominantly functional TR (LTR-B). Compared to non-CIED-carriers, CIED carriers were more symptomatic (NYHA-FC > II; 93% vs. 89%; p = 0.026) with comparable TR severity at baseline. Intraprocedural success according to the Tricuspid Valve Academic Research Consortium was 68% in CIED carriers and 70% in non-CIED carriers (p = 0.851). LTR-A was associated with poorer TR reduction immediately after TTVA (p = 0.022). Overall safety was comparable, with right ventricular lead dislodgement occurring in one patient. Beyond that, CIED function remained unimpaired. At 30 days, echocardiographic follow-up showed comparable TR reduction (TR ≤ II: 56% vs. 68%; p = 0.219) and NYHA-FU ≤ II (63% vs. 70%; p = 0.524) in CIED-and non-CIED carriers, respectively.</p><p><strong>Conclusions: </strong>TTVA achieves significant TR reduction, providing a safe and effective therapeutic option for TR treatment in CIED carriers. WHAT IS KNOWN?: TTVA using the Cardioband has been approved for severe, symptomatic TR patients, however data on the safety and efficacy in CIED carriers is lacking. WHAT THE STUDY ADDS?: Intraprocedural success and safety were comparable in CIED and non-CIED carriers treated with TTVA. Subgroup analyses showed a trend towards worse outcome and efficiency of TTVA in patients with LTR-A. 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Intraprocedural success according to the Tricuspid Valve Academic Research Consortium was 68% in CIED carriers and 70% in non-CIED carriers (p = 0.851). LTR-A was associated with poorer TR reduction immediately after TTVA (p = 0.022). Overall safety was comparable, with right ventricular lead dislodgement occurring in one patient. Beyond that, CIED function remained unimpaired. At 30 days, echocardiographic follow-up showed comparable TR reduction (TR ≤ II: 56% vs. 68%; p = 0.219) and NYHA-FU ≤ II (63% vs. 70%; p = 0.524) in CIED-and non-CIED carriers, respectively.</p><p><strong>Conclusions: </strong>TTVA achieves significant TR reduction, providing a safe and effective therapeutic option for TR treatment in CIED carriers. WHAT IS KNOWN?: TTVA using the Cardioband has been approved for severe, symptomatic TR patients, however data on the safety and efficacy in CIED carriers is lacking. 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引用次数: 0
摘要
背景：经三尖瓣心脏植入式电子装置（CIEDs）使三尖瓣反流（TR）的治疗复杂化。经导管三尖瓣成形术（TTVA）提供了一种很有前途的方法，因为它与小叶和经瓣cied的相互作用最小，尽管实际证据有限。方法：本双中心回顾性研究包括204例连续使用Cardioband （Edwards Lifesciences）治疗严重症状性TR的TTVA患者。患者分为CIED携带者和非CIED携带者。将CIED携带者进一步分为导联相关性TR （LTR-A）和与CIED导联无关的TR （LTR-B）。结果：204例患者中，41例（20%）为CIED携带者。其中24%为混合TR病因（功能性和LTR-A）， 76%为主要功能性TR （LTR-B）。与非CIED携带者相比，CIED携带者症状更明显(NYHA-FC > II；93% vs 89%；p = 0.026)，基线时TR严重程度可比较。根据三尖瓣学术研究联盟的数据，CIED携带者术中成功率为68%，非CIED携带者为70% （p = 0.851）。LTR-A与TTVA后较差的TR降低相关（p = 0.022）。总体安全性相当，1例患者出现右心室导联脱位。除此之外，CIED功能未受损害。在30天的超声心动图随访中显示TR降低(TR≤II: 56% vs. 68%；p = 0.219)和NYHA-FU≤II (63% vs. 70%；p = 0.524)。结论：TTVA显著降低了CIED携带者的TR，为其TR治疗提供了安全有效的治疗选择。什么是已知的?使用Cardioband的TTVA已被批准用于严重症状性TR患者，但缺乏关于CIED携带者的安全性和有效性的数据。这项研究补充了什么？TTVA治疗的CIED和非CIED携带者术中成功率和安全性相当。亚组分析显示LTR-A患者TTVA的预后和疗效更差。介入后的CIED审讯没有显示出关键的技术问题。
Background: Transtricuspid cardiac implantable electronic devices (CIEDs) complicate the management of tricuspid regurgitation (TR). Transcatheter tricuspid valve annuloplasty (TTVA) offers a promising approach due to minimal interaction with leaflets and transvalvular CIEDs, though real-world evidence is limited.
Methods: This bi-center, retrospective study includes 204 consecutive patients who underwent TTVA with the Cardioband (Edwards Lifesciences) for severe symptomatic TR. Patients were divided into CIED carriers and non-CIED carriers. CIED carriers were further classified into those with lead-associated TR (LTR-A) and those with TR unrelated to CIED leads (LTR-B).
Results: Among the 204 patients, 41 (20%) were CIED carriers. Of these, 24% had mixed TR etiology (functional and LTR-A), while 76% had predominantly functional TR (LTR-B). Compared to non-CIED-carriers, CIED carriers were more symptomatic (NYHA-FC > II; 93% vs. 89%; p = 0.026) with comparable TR severity at baseline. Intraprocedural success according to the Tricuspid Valve Academic Research Consortium was 68% in CIED carriers and 70% in non-CIED carriers (p = 0.851). LTR-A was associated with poorer TR reduction immediately after TTVA (p = 0.022). Overall safety was comparable, with right ventricular lead dislodgement occurring in one patient. Beyond that, CIED function remained unimpaired. At 30 days, echocardiographic follow-up showed comparable TR reduction (TR ≤ II: 56% vs. 68%; p = 0.219) and NYHA-FU ≤ II (63% vs. 70%; p = 0.524) in CIED-and non-CIED carriers, respectively.
Conclusions: TTVA achieves significant TR reduction, providing a safe and effective therapeutic option for TR treatment in CIED carriers. WHAT IS KNOWN?: TTVA using the Cardioband has been approved for severe, symptomatic TR patients, however data on the safety and efficacy in CIED carriers is lacking. WHAT THE STUDY ADDS?: Intraprocedural success and safety were comparable in CIED and non-CIED carriers treated with TTVA. Subgroup analyses showed a trend towards worse outcome and efficiency of TTVA in patients with LTR-A. Postinterventional CIED interrogations did not show critical technical issues.
期刊介绍：
Clinical Research in Cardiology is an international journal for clinical cardiovascular research. It provides a forum for original and review articles as well as critical perspective articles. Articles are only accepted if they meet stringent scientific standards and have undergone peer review. The journal regularly receives articles from the field of clinical cardiology, angiology, as well as heart and vascular surgery.
As the official journal of the German Cardiac Society, it gives a current and competent survey on the diagnosis and therapy of heart and vascular diseases.
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