Abstract:
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.
摘要:
经导管心房分流治疗,旨在通过将血液分流到右心房和中央静脉的较大储存器来动态降低左心房(LA)压力,在过去的10多年中,已被开发为心力衰竭(HF)的新型治疗方法。目前正在开发几种心房分流装置和程序,并正在进行一些关键的随机临床试验(RCT);然而,到目前为止,仅有2例假对照RCT(均使用心房分流装置[CorviaMedical]治疗EF≥40%的HF)被报道;1个月时机械RCT(n=44)显示运动LA压力降低,1个月时关键RCT(n=626)为中性,分流组和假手术组的结局或健康状况无差异.随后对完成的单个关键RCT的分析发现,峰值运动肺血管阻力<1.74WU加上没有心律管理设备,确定了一个从心房分流术植入的LA卸载中受益的响应者组。这一发现目前正在随访RCT中得到证实。在这里,我们对心房分流治疗领域进行了全面的回顾,并描述了以下内容:(1)当前的HF治疗;(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程序的设计和积累的证据;(4)该领域未解决的问题;(5)未来的考虑。心房分流代表了HF的潜在创新疗法,但最可能受益的HF的最佳设计/方法和表型尚未确定。