Leeds Institute of Cardiovascular and Metabolic Medicine, Multidisciplinary Cardiovascular Research Centre, University of Leeds, Leeds, United Kingdom.
Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom.
PLoS One. 2021 Dec 13;16(12):e0259450. doi: 10.1371/journal.pone.0259450. eCollection 2021.
Pacemakers are widely utilised to treat bradycardia, but right ventricular (RV) pacing is associated with heightened risk of left ventricular (LV) systolic dysfunction and heart failure. We aimed to compare personalised pacemaker reprogramming to avoid RV pacing with usual care on echocardiographic and patient-orientated outcomes.
A prospective phase II randomised, double-blind, parallel-group trial in 100 patients with a pacemaker implanted for indications other than third degree heart block for ≥2 years. Personalised pacemaker reprogramming was guided by a published protocol. Primary outcome was change in LV ejection fraction on echocardiography after 6 months. Secondary outcomes included LV remodeling, quality of life, and battery longevity.
Clinical and pacemaker variables were similar between groups. The mean age (SD) of participants was 76 (+/-9) years and 71% were male. Nine patients withdrew due to concurrent illness, leaving 91 patients in the intention-to-treat analysis. At 6 months, personalised programming compared to usual care, reduced RV pacing (-6.5±1.8% versus -0.21±1.7%; p<0.01), improved LV function (LV ejection fraction +3.09% [95% confidence interval (CI) 0.48 to 5.70%; p = 0.02]) and LV dimensions (LV end systolic volume indexed to body surface area -2.99mL/m2 [95% CI -5.69 to -0.29; p = 0.03]). Intervention also preserved battery longevity by approximately 5 months (+0.38 years [95% CI 0.14 to 0.62; p<0.01)) with no evidence of an effect on quality of life (+0.19, [95% CI -0.25 to 0.62; p = 0.402]).
Personalised programming in patients with pacemakers for bradycardia can improve LV function and size, extend battery longevity, and is safe and acceptable to patients.
ClinicalTrials.gov identifier: NCT03627585.
起搏器被广泛用于治疗心动过缓，但右心室（RV）起搏与左心室（LV）收缩功能障碍和心力衰竭的风险增加有关。我们旨在比较个性化起搏器重新编程以避免 RV 起搏与常规护理对超声心动图和患者导向结果的影响。
这是一项前瞻性的 II 期随机、双盲、平行组试验，纳入了 100 名因三度心脏阻滞以外的其他原因植入起搏器且植入时间≥2 年的患者。个性化起搏器重新编程是根据已发表的方案进行指导的。主要结局是 6 个月后超声心动图上 LV 射血分数的变化。次要结局包括 LV 重构、生活质量和电池寿命。
两组的临床和起搏器变量相似。参与者的平均年龄（SD）为 76（+/-9）岁，71%为男性。由于并发疾病，有 9 名患者退出，因此在意向治疗分析中，有 91 名患者。6 个月时，与常规护理相比，个性化编程减少了 RV 起搏（-6.5±1.8%比-0.21±1.7%；p<0.01），改善了 LV 功能（LV 射血分数增加 3.09%[95%置信区间（CI）0.48 至 5.70%；p=0.02]）和 LV 尺寸（LV 收缩末期容积指数化到体表面积减少 2.99mL/m2[95%CI-5.69 至-0.29；p=0.03]）。干预还延长了电池寿命，大约 5 个月（+0.38 年[95%CI 0.14 至 0.62；p<0.01]），并且没有证据表明对生活质量有影响（+0.19，[95%CI-0.25 至 0.62；p=0.402]）。
在患有心动过缓的起搏器患者中进行个性化编程可以改善 LV 功能和大小，延长电池寿命，并且对患者是安全且可接受的。
ClinicalTrials.gov 标识符：NCT03627585。
