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房室同步优化希氏束起搏对心力衰竭症状和运动能力的影响:希氏优化起搏评估心力衰竭(HOPE-HF)随机、双盲、交叉试验。

Effects of haemodynamically atrio-ventricular optimized His bundle pacing on heart failure symptoms and exercise capacity: the His Optimized Pacing Evaluated for Heart Failure (HOPE-HF) randomized, double-blind, cross-over trial.

机构信息

National Heart and Lung Institute, Imperial College London, London, UK.

Imperial College Healthcare NHS Trust, London, UK.

出版信息

Eur J Heart Fail. 2023 Feb;25(2):274-283. doi: 10.1002/ejhf.2736.

Abstract

AIMS

Excessive prolongation of PR interval impairs coupling of atrio-ventricular (AV) contraction, which reduces left ventricular pre-load and stroke volume, and worsens symptoms. His bundle pacing allows AV delay shortening while maintaining normal ventricular activation. HOPE-HF evaluated whether AV optimized His pacing is preferable to no-pacing, in a double-blind cross-over fashion, in patients with heart failure, left ventricular ejection fraction (LVEF) ≤40%, PR interval ≥200 ms and either QRS ≤140 ms or right bundle branch block.

METHODS AND RESULTS

Patients had atrial and His bundle leads implanted (and an implantable cardioverter-defibrillator lead if clinically indicated) and were randomized to 6 months of pacing and 6 months of no-pacing utilizing a cross-over design. The primary outcome was peak oxygen uptake during symptom-limited exercise. Quality of life, LVEF and patients' holistic symptomatic preference between arms were secondary outcomes. Overall, 167 patients were randomized: 90% men, 69 ± 10 years, QRS duration 124 ± 26 ms, PR interval 249 ± 59 ms, LVEF 33 ± 9%. Neither peak oxygen uptake (+0.25 ml/kg/min, 95% confidence interval [CI] -0.23 to +0.73, p = 0.3) nor LVEF (+0.5%, 95% CI -0.7 to 1.6, p = 0.4) changed with pacing but Minnesota Living with Heart Failure quality of life improved significantly (-3.7, 95% CI -7.1 to -0.3, p = 0.03). Seventy-six percent of patients preferred His bundle pacing-on and 24% pacing-off (p < 0.0001).

CONCLUSION

His bundle pacing did not increase peak oxygen uptake but, under double-blind conditions, significantly improved quality of life and was symptomatically preferred by the clear majority of patients. Ventricular pacing delivered via the His bundle did not adversely impact ventricular function during the 6 months.

摘要

目的

PR 间期过长会损害房室(AV)收缩的耦联,从而降低左心室前负荷和每搏输出量,并使症状恶化。希氏束起搏可缩短 AV 延迟,同时保持正常的心室激活。HOPE-HF 评估了在心力衰竭、左心室射血分数(LVEF)≤40%、PR 间期≥200ms 且 QRS 波群≤140ms 或右束支传导阻滞的患者中,以双盲交叉方式进行的 AV 优化希氏束起搏是否优于无起搏。

方法和结果

患者植入了心房和希氏束导联(如果临床需要,还植入了植入式心脏复律除颤器导联),并采用交叉设计随机分为 6 个月起搏和 6 个月无起搏。主要终点是症状限制运动时的峰值摄氧量。生活质量、LVEF 和患者在两个臂之间的整体症状偏好是次要终点。总体上,167 名患者被随机分组:90%为男性,69±10 岁,QRS 持续时间 124±26ms,PR 间期 249±59ms,LVEF 33±9%。无论是峰值摄氧量(增加 0.25ml/kg/min,95%置信区间[CI] -0.23 至 +0.73,p=0.3)还是 LVEF(增加 0.5%,95%CI -0.7 至 1.6,p=0.4)都没有因起搏而改变,但明尼苏达州心力衰竭生活质量评分显著改善(-3.7,95%CI -7.1 至 -0.3,p=0.03)。76%的患者更喜欢希氏束起搏开启,而 24%的患者更喜欢希氏束起搏关闭(p<0.0001)。

结论

希氏束起搏并未增加峰值摄氧量,但在双盲条件下,显著改善了生活质量,且绝大多数患者都明显更喜欢希氏束起搏。在 6 个月的时间内,通过希氏束传递的心室起搏不会对心室功能产生不利影响。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3f49/10946926/444773ff72ab/EJHF-25-274-g001.jpg

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