双心室起搏预防高度房室传导阻滞患者心功能不全的研究

Efficacy of biventricular pacing on preventing heart failure in patients with high degree atrioventricular block （BIVPACE-AVB Trial）

目的 观察双心室（BIV）和右室心尖部（RVA）起搏对左心室射血分数（LVEF）超过35％的高度房室传导阻滞（AVB）患者心功能的长期影响.方法 采用随机、双盲、平行对照方法,对2009年5月至2012年12月间在华东6家医院就诊的118例高度AVB患者行心脏再同步化治疗（CRT）.双心室起搏1周后区组随机化1∶1程控左心室电极开闭分为BIV组和RVA组各57例,评价患者6和12个月纽约心脏协会（NYHA）心功能分级、6 min步行距离（6MWD）、明尼苏达心力衰竭生活质量评分（MLHF评分）、左心室射血分数（LVEF）、左心室舒张末期容积和内径（LVEDV和LVEDD）和N末端B型利钠肽原（NT-proBNP）等指标.结果 114例患者成功植入CRT,BIV起搏1周时较术前NYHAⅢ级患者比例[25.44％ （29/114）比9.65％ （11/114）]、MLHF评分（17.1±13.6比26.9±21.6）、6MWD[（315.4±121.8）m比（291.8±102.9）m]和NT-proBNP[157.0（70.0,639.0）比444.7（144.0,1 546.0）]均明显改善（P均＜0.05）.BIV组患者术后6个月的6MWD[（332.7±117.5）m比（314.8±142.7） m]和LVEF[（60.7±7.9）％比（56.6±10.7）％]明显高于术后1周（P均＜0.05）,术后12个月LVEDV[（116.2±39.5）ml比（131.4±49.6） ml]和LVEDD[（50.2±5.6）mm比（52.5±6.8）mm]明显低于术后1周（P均＜0.05）.RVA组患者术后6个月6MWD[（342.4±109.9）m比（310.2±105.1）m]、NT-proBNP[349.5（191.8,884.3）ng/L比127.0（70.3,336.7）ng/L]高于术后1周（P均＜0.05）;BIV组与RVA组比较,LVEDV术后12个月比术后1周缩小值更大[（-16.68±24.30）ml比（9.09±29.30）ml,P＜0.05].结论 对LVEF＞ 35％的高度AVB患者,CRT早期即可改善心功能;12个月时,BIV起搏改善心功能、缩小心脏容积等较RVA起搏更为明显,并可预防心功能恶化.临床试验注册 中国临床试验注册中心,注册号ChiCTR-TRC-10000832.

Objective To investigate the long-term effect of biventricular （BIV） and right ventricular apical （RVA） pacing on cardiac function in patients with high-degree atrioventricular block （AVB） and left ventricular ejection fraction （LVEF）over 35%.Methods A total of 118 consecutive patients with high-degree AVB in six hospitals from East China between May 2009 and December 2012 were enrolled in this randomized,double-blind and parallel controlled study.Patients were randomly assigned to BIV and RVA pacing with or without LV lead on after one-week cardiac resynchronization therapy （CRT）.Cardiac function including New York Heart Association （NYHA）,6 minute walking distance （6MWD）,Minnesota living with heart failure （MLHF） score,LVEF,left ventricular end-diastolic volumes/diameters （LVEDV/LVEDD） and other echocardiography parameters,as well as N-terminal pro-B-type natriuretic peptide （NT-proBNP）were assessed at 6 months and 12 months.Results A total of 114 patients were successfully implanted with CRT.Cardiac function was significantly improved after one-week BIV pacing （n=57） compared with pre-CRT：rate of patients with NYHA [（25.44% （29/114） vs.9.65% （11/ 114））,MLHF score （17.1 ± 13.6 vs.26.9 ±21.6）,6MWD （（315.4 ± 121.8）m vs.（291.8 ± 102.9） m） and NT-proBNP （157.0 （70.0,639.0） ng/L vs.444.7（144.0,1 546.0）ng/L,all P 〈 0.05）.In BIV group,6MWD extended from （314.8 ± 142.7） m to （332.7 ± 117.5） m at 6 months （P 〈 0.05）,LVEF increased from （60.7 ±7.9）% at 1 week to （56.6 ± 10.7）% at 6 months（P 〈0.05）,both LVEDV and LVEDD decreased at 12 months compared with at 1 week （（116.2 ± 39.5） ml vs.（131.4 ± 49.6） ml and （50.2 ±5.6）mm vs.（52.5 ±6.8）mm,P 〈0.05）.In RVA group （n =57）,6MWD increased at 6 months compared that at 1 week （（342.4 ± 109.9） m vs.（310.2 ± 105.1） m,P 〈 0.05）,NT-proBNP was higher at 12 months than that at 1 week （349.5 （191.8,884.3） ng/L vs.127.0 （70.3,336.7） ng/L,P 〈 0.05）.Compared with RVA group,BIV group had a bigger shrink in LVEDV decrease at 12 months was more significant in BIV group （（-16.68 ± 24.30） ml vs.（9.09 ± 29.30） ml,P 〈 0.05）.Conclusions Cardiac pacing could acutely improve the cardiac function in patients with high-degree AVB and LVEF over 35%.Improvements on cardiac function and remodeling are more significant after 12-month BIV pacing than that of RVA pacing.Clinical Trail Registry Chinese Clinical Trial Registry,ChiCTR-TRC-10000832.