Department of Internal Medicine III, Cardiology, Angiology, Intensive Care Medicine, Saarland University Medical Center, Saarland University, Saarbrücken, Germany.
Chevening Scholar, Decision Modelling and Evidence Synthesis, University of Leicester, Leicester, UK.
Eur J Heart Fail. 2021 Nov;23(11):1960-1970. doi: 10.1002/ejhf.2360. Epub 2021 Nov 5.
To assess the feasibility and efficacy of interatrial shunt devices (IASD) for the treatment of chronic heart failure (CHF).
MEDLINE and the Cochrane Central Register of Controlled Trials from inception until April 2021 were searched for prospective studies investigating dedicated transcatheter IASD for the treatment of CHF. Standardised mean differences were calculated for the within-group changes before and after implantation of the IASD. The pre-defined primary outcome was change in 6-min walking distance (6MWD) from baseline to 12 months. Other outcomes were change in New York Heart Association class, health-related quality of life (HRQoL), echocardiographic and haemodynamic data, device performance and safety. Subgroup analyses were crude univariable meta-regression analyses. Six studies (five single-arm open-label studies, one sham-controlled trial) were included. In these, 226 patients underwent IASD implantation using four different devices. From baseline to 12 months, 6MWD increased by 28.1 m [95% confidence interval (CI) 10.9-45.3] with no evidence for a difference between devices (P for interaction = 0.66) and patients with left ventricular ejection fraction (LVEF) >40% or ≤40% (P for interaction = 0.21). At 12 months, HRQoL improved by 17.7 points (95% CI 10.8-24.6) and pulmonary capillary wedge pressure (PCWP) decreased by 2.0 mmHg (95% CI -3.6 to -0.4). There were no changes in LVEF or N-terminal pro brain natriuretic peptide during follow-up. Shunt patency ranged from 50% for the first-generation v-Wave to 100% for the Corvia IASD II and the second-generation v-Wave system, respectively. The summary risk of serious adverse device-related effects was 8% (95% CI 1-20) at 12 months.
Interatrial shunt device implantation in CHF is feasible and associates with improved submaximal exercise capacity (measured by 6MWD) and HRQoL, and reductions in PCWP.
评估房间隔分流装置（IASD）治疗慢性心力衰竭（CHF）的可行性和疗效。
检索 MEDLINE 和 Cochrane 对照试验中心注册库，纳入从建库至 2021 年 4 月所有前瞻性研究，评估经导管专用 IASD 治疗 CHF。计算 IASD 植入前后组内变化的标准化均数差。预先设定的主要结局为 6 分钟步行距离（6MWD）从基线到 12 个月的变化。其他结局为纽约心脏协会（NYHA）心功能分级、健康相关生活质量（HRQoL）、超声心动图和血液动力学数据、设备性能和安全性的变化。亚组分析为未校正单变量荟萃回归分析。纳入 6 项研究（5 项单臂开放标签研究，1 项假对照试验），共 226 例患者接受了 4 种不同装置的 IASD 植入。从基线到 12 个月，6MWD 增加了 28.1m[95%置信区间（CI）为 10.9-45.3]，不同装置之间无差异（P 交互=0.66），且左心室射血分数（LVEF）＞40%或≤40%的患者之间也无差异（P 交互=0.21）。12 个月时，HRQoL 改善了 17.7 分（95%CI 为 10.8-24.6），肺毛细血管楔压（PCWP）下降了 2.0mmHg（95%CI 为-3.6 至-0.4）。随访期间 LVEF 或 N 末端脑利钠肽前体无变化。第一代 v-Wave 的分流通畅率为 50%，第二代 v-Wave 系统和 Corvia IASD II 的分流通畅率分别为 100%。12 个月时严重不良设备相关不良事件的汇总风险为 8%（95%CI 为 1-20）。
在 CHF 中植入房间隔分流装置是可行的，与改善亚极量运动能力（通过 6MWD 测量）和 HRQoL 相关，并降低 PCWP。
