Health Technology Assessment Area-AETSA, Andalusian Public Foundation Progress and Health-FPS, Seville, Spain.
Heart Failure and Cardiomyopathy Unit, Cardiology Service Ramón y Cajal Hospital, Madrid, Spain.
ESC Heart Fail. 2023 Oct;10(5):2760-2772. doi: 10.1002/ehf2.14473. Epub 2023 Jul 31.
Baroreflex activation therapy (BAT) is a possible adjuvant treatment for patients with heart failure with reduced ejection fraction (HFrEF) who remain symptomatic despite optimal medical therapy and may be an alternative therapy in patients with contraindications or drug intolerance. Our aim was to evaluate the efficacy and safety of BAT in patients with HFrEF. The protocol for this study was registered with PROSPERO (CRD42022349175). Searches were conducted using MEDLINE, preMedLine (via PubMed), EMBASE, Cochrane Library, Web of Science, Trip Medical Database, WHO International Clinical Trials Registry, and ClinicalTrials.gov. We included randomized controlled trials that compared the effects of BAT with pharmacological treatment. We assessed the risk of bias of each study using the Cochrane RoB2 tool and the certainty of the results using the GRADE approach. We performed a meta-analysis of treatment effects using a fixed-effects or random-effects model, depending on the heterogeneity observed. Two studies were included in the meta-analysis (HOPE4HF and BeAT-HF). The results showed that BAT led to statistically significant improvements in New York Heart Association functional class (relative risk 2.13; 95% confidence interval [CI, 1.65 to 2.76]), quality of life (difference in means -16.97; 95% CI [-21.87 to -12.07]), 6 min walk test (difference in means 56.54; 95% CI [55.67 to 57.41]) and N-terminal probrain natriuretic peptide (difference in means -120.02; 95% CI [-193.58 to -46.45]). The system- and procedure-related complication event-free rate varied from 85.9% to 97%. The results show that BAT is safe and improves functional class, quality of life and congestion in selected patients with HFrEF. Further studies and long-term follow-up are needed to assess efficacy in reducing cardiovascular events and mortality.
压力感受反射激活治疗（BAT）是一种可能的辅助治疗方法，适用于射血分数降低的心力衰竭（HFrEF）患者，这些患者尽管接受了最佳的药物治疗，但仍有症状，并且可能是有禁忌症或药物不耐受的患者的替代治疗方法。我们的目的是评估 BAT 在 HFrEF 患者中的疗效和安全性。该研究的方案已在 PROSPERO（CRD42022349175）上注册。使用 MEDLINE、预 MedLine（通过 PubMed）、EMBASE、Cochrane 图书馆、Web of Science、Trip 医学数据库、世界卫生组织国际临床试验注册平台和 ClinicalTrials.gov 进行了检索。我们纳入了比较 BAT 与药物治疗效果的随机对照试验。我们使用 Cochrane RoB2 工具评估每项研究的偏倚风险，并使用 GRADE 方法评估结果的确定性。我们根据观察到的异质性，使用固定效应或随机效应模型对治疗效果进行荟萃分析。有两项研究被纳入荟萃分析（HOPE4HF 和 BeAT-HF）。结果表明，BAT 可显著改善纽约心脏协会功能分级（相对风险 2.13；95%置信区间 [CI]，1.65 至 2.76）、生活质量（平均差值 -16.97；95%CI [-21.87 至 -12.07]）、6 分钟步行测试（平均差值 56.54；95%CI [55.67 至 57.41]）和 N 端脑利钠肽前体（平均差值 -120.02；95%CI [-193.58 至 -46.45]）。系统和程序相关并发症的无事件率为 85.9%至 97%。结果表明，BAT 是安全的，可改善选定的 HFrEF 患者的功能分级、生活质量和充血。需要进一步的研究和长期随访来评估其在降低心血管事件和死亡率方面的疗效。
