Division of Cardiovascular and Diabetes Research, Leeds Institute of Genetics, Health and Therapeutics, Multidisciplinary Cardiovascular Research Centre, University of Leeds, Clarendon Way, Leeds LS2 9JT, UK.
Europace. 2013 Nov;15(11):1609-14. doi: 10.1093/europace/eut148. Epub 2013 Jun 4.
Heart failure and left ventricular (LV) systolic dysfunction (LVSD) are common in patients with permanent pacemakers. The aim was to determine if cardiac resynchronization therapy (CRT) at the time of pulse generator replacement (PGR) is of benefit in patients with unavoidable RV pacing and LVSD.
Fifty patients with unavoidable RV pacing, LVSD, and mild or no symptoms of heart failure, listed for PGR were randomized 1 : 1 to either standard RV-PGR (comparator) or CRT. The primary endpoint was the difference in change in LV ejection fraction (LVEF) between RV-PGR and CRT groups from baseline to 6 months. Secondary endpoints included peak oxygen consumption, quality of life, and N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels. At 6 months there was a difference in change in median (interquartile range) LVEF [9 (6-12) vs. -1.5 (-4.5 to -0.8)%; P < 0.0001] between the CRT and RV-PGR arms. There were also improvements in exercise capacity (P = 0.007), quality of life (P = 0.03), and NT-proBNP (P = 0.007) in those randomized to CRT. After 809 (729-880) days, 17 patients had died or been hospitalized (6 in CRT group and 11 in the comparator RV-PGR group) and two patients in the RV-PGR arm had required CRT for deteriorating heart failure. Patients with standard RV-PGR had more days in hospital during follow-up than those in the CRT group [4 (2-7) vs. 11 (6-16) days; P = 0.047].
Performing CRT in pacemaker patients with unavoidable RV pacing and LVSD but without severe symptoms of heart failure, at the time of PGR, improves cardiac function, exercise capacity, quality of life, and NT-pro-BNP levels.
心力衰竭和左心室(LV)收缩功能障碍(LVSD)在永久性起搏器患者中很常见。本研究旨在确定在更换脉冲发生器(PGR)时进行心脏再同步治疗(CRT)是否对不可避免的右心室(RV)起搏和 LVSD 患者有益。
50 例不可避免的 RV 起搏、LVSD 和轻度或无心力衰竭症状的患者,因需要 PGR 而被列入研究,他们被 1:1 随机分为标准 RV-PGR(对照组)或 CRT 组。主要终点是从基线到 6 个月时 RV-PGR 和 CRT 组之间 LV 射血分数(LVEF)变化的差异。次要终点包括峰值耗氧量、生活质量和 N 末端 pro-B 型利钠肽(NT-proBNP)水平。6 个月时,CRT 组和 RV-PGR 组之间 LVEF 中位数(四分位距)的变化差异有统计学意义[9(6-12)%对-1.5(-4.5 至-0.8)%;P<0.0001]。在 CRT 组中,运动能力(P=0.007)、生活质量(P=0.03)和 NT-proBNP(P=0.007)也有改善。在 809(729-880)天的随访中,17 例患者死亡或住院(CRT 组 6 例,对照组 RV-PGR 组 11 例),2 例 RV-PGR 组患者因心力衰竭恶化需要 CRT。与 CRT 组相比,接受标准 RV-PGR 的患者在随访期间住院天数更多[4(2-7)天对 11(6-16)天;P=0.047]。
在 PGR 时对不可避免的 RV 起搏和 LVSD 但无严重心力衰竭症状的起搏器患者进行 CRT,可以改善心功能、运动能力、生活质量和 NT-pro-BNP 水平。