Jagadeesan Vikrant, Gray William A, Shah Sanjiv J
West Virginia Heart and Vascular Institute, West Virginia School of Medicine, Morgantown, West Virginia.
Main Line Health System, Thomas Jefferson University, Wynnewood, Pennsylvania.
J Soc Cardiovasc Angiogr Interv. 2023 Dec 4;2(6Part B):101203. doi: 10.1016/j.jscai.2023.101203. eCollection 2023 Nov-Dec.
Transcatheter atrial shunt therapies, designed to dynamically lower left atrial (LA) pressure by shunting blood into the larger reservoir of the right atrium and central veins, have been developed as a novel treatment for heart failure (HF) over the past 10+ years. Several atrial shunt devices and procedures are currently in development with several pivotal randomized clinical trials (RCT) underway; however, only 2 sham-controlled RCT (both with the Atrial Shunt Device [Corvia Medical] in HF with EF ≥ 40%) have been reported thus far; a mechanistic RCT (n = 44) that demonstrated a reduction in exercise LA pressure at 1 month and a pivotal RCT (n = 626) that was neutral with no difference in outcomes or health status between shunt and sham groups. Subsequent analyses of the single completed pivotal RCT found that peak exercise pulmonary vascular resistance <1.74 WU plus the absence of a cardiac rhythm management device identified a responder group that benefited from LA unloading with atrial shunt implantation, a finding that is currently being confirmed in a follow-up RCT. Here we provide a comprehensive review of the field of atrial shunt therapeutics with a description of the following: (1) current HF treatment; (2) rationale and history of atrial shunt development; (3) design of and accumulated evidence for the various atrial shunt devices and procedures under investigation; (4) unanswered questions in the field; and (5) future considerations. Atrial shunts represent a potential innovative therapeutic for HF but the optimal design/approach and phenotype of HF most likely to benefit are yet to be determined.
经导管心房分流疗法旨在通过将血液分流到右心房和中心静脉这个更大的血库中，动态降低左心房（LA）压力，在过去十多年里已被开发为一种治疗心力衰竭（HF）的新方法。目前有几种心房分流装置和手术正在研发中，同时有多项关键的随机临床试验（RCT）正在进行；然而，迄今为止仅报道了2项假手术对照的RCT（均使用心房分流装置[Corvia Medical]治疗射血分数（EF）≥40%的HF）；一项机制性RCT（n = 44）显示1个月时运动时左心房压力降低，以及一项关键的RCT（n = 626），该试验结果呈中性，分流组和假手术组在结局或健康状况方面无差异。对唯一一项已完成的关键RCT的后续分析发现，运动峰值肺血管阻力<1.74伍德单位（WU）且未使用心律管理装置可确定一个受益于心房分流植入减轻左心房负荷的反应者组，这一发现目前正在一项后续RCT中得到证实。在此，我们对心房分流治疗领域进行全面综述，内容包括：（1）目前的HF治疗方法；（2）心房分流发展的原理和历史；（3）正在研究的各种心房分流装置和手术的设计及积累的证据；（4）该领域尚未解决的问题；（5）未来的考虑因素。心房分流代表了一种潜在的HF创新治疗方法，但最可能受益的HF的最佳设计/方法和表型尚未确定。
