基于磁共振成像的双导心脏再同步治疗：前瞻性左束支起搏研究（MADURAI LBBP 研究）。
MAgnetic resonance imaging based DUal lead cardiac Resynchronization therapy: A prospectIve Left Bundle Branch Pacing study (MADURAI LBBP study).
机构信息
Department of Cardiology, Velammal Medical College, Madurai, India.
Department of Microbiology, Velammal Medical College, Madurai, India.
出版信息
Heart Rhythm. 2023 Aug;20(8):1119-1127. doi: 10.1016/j.hrthm.2023.05.019. Epub 2023 May 20.
BACKGROUND
Cardiac resynchronization therapy (CRT) is a class I indication for left ventricular ejection fraction (LVEF) ≤35% and heart failure (HF). Left bundle branch block (LBBB)-associated nonischemic cardiomyopathy (LB-NICM) with minimal or no scar by cardiac magnetic resonance (CMR) imaging may be associated with excellent prognosis following CRT. Left bundle branch pacing (LBBP) can achieve excellent resynchronization in LBBB patients.
OBJECTIVES
The purpose of this study was to prospectively assess the feasibility and efficacy of LBBP with or without a defibrillator in patients with LB-NICM and LVEF ≤35%, risk stratified by CMR.
METHODS
Patients with LB-NICM, LVEF ≤35%, and HF were prospectively enrolled from 2019 to 2022. If the scar burden was <10% by CMR then LBBP only (group I) and if ≥10% then LBBP + implantable cardioverter-defibrillator (ICD) (group II) was performed. Primary endpoints were (1) echocardiographic response (ER) [ΔLVEF ≥15%] at 6 months; and (2) composite of time to death, heart failure hospitalization (HFH), or sustained ventricular tachycardia (VT)/ventricular fibrillation (VF). Secondary endpoints were (1) echocardiographic hyperresponse (EHR) [LVEF ≥50% or ΔLVEF ≥20%] at 6 and 12 months; and (2) indication for ICD upgrade [persistent LVEF <35% at 12 months or sustained VT/VF].
RESULTS
One hundred twenty patients were enrolled. CMR showed <10% scar burden in 109 patients (90.8%). Four patients opted for LBBP+ICD and withdrew. LBBP-optimized dual-chamber pacemaker (LOT-DDD-P) was performed in 101 patients and LOT-CRT-P in 4 patients (group I; n = 105). Eleven patients with scar burden ≥10% underwent LBBP+ICD (group II). During mean-follow-up of 21 ± 12 months, the primary endpoint of ER was observed in 80% (68/85 patients) in group I vs 27% (3/11 patients) in group II (P = .0001). Primary composite endpoint of death, HFH, or VT/VF occurred in 3.8% in group I vs 33.3% in group II (P <.0001). Secondary endpoint of EHR (LVEF≥50%) was observed in 39.5% vs 0%, 61.2% vs 9.1%, and 80% vs 33.3% at 3, 6, and 12 months in groups I and II, respectively.
CONCLUSION
CMR-guided CRT using LOT-DDD-P seems to be a safe and feasible approach in LB-NICM and has the potential to reduce health care costs.
背景
心脏再同步治疗（CRT）是左心室射血分数（LVEF）≤35%和心力衰竭（HF）的 I 类适应证。心脏磁共振（CMR）成像显示左束支传导阻滞（LBBB）相关非缺血性心肌病（LB-NICM）伴最小或无瘢痕的患者，在 CRT 后可能具有极好的预后。左束支起搏（LBBP）可在 LBBB 患者中实现极好的同步化。
目的
本研究前瞻性评估了在 LVEF≤35%、CMR 分层风险的 LB-NICM 患者中，伴或不伴除颤器的 LBBP 的可行性和疗效。
方法
2019 年至 2022 年期间，前瞻性招募了 LVEF≤35%且伴有 HF 的 LB-NICM 患者。如果 CMR 显示瘢痕负荷<10%，则仅行 LBBP（I 组），如果瘢痕负荷≥10%，则行 LBBP+植入式心脏复律除颤器（ICD）（II 组）。主要终点为（1）6 个月时超声心动图反应（ER）[LVEF 增加≥15%]；和（2）死亡、心力衰竭住院（HFH）或持续性室性心动过速（VT）/心室颤动（VF）复合终点。次要终点为（1）6 个月和 12 个月时超声心动图超反应（EHR）[LVEF≥50%或 LVEF 增加≥20%]；和（2）ICD 升级指征[12 个月时持续 LVEF<35%或持续性 VT/VF]。
结果
共纳入 120 例患者。CMR 显示 109 例（90.8%）患者瘢痕负荷<10%。4 例患者选择 LBBP+ICD 并退出。在 101 例患者中进行了 LBBP 优化的双腔起搏器（LOT-DDD-P）治疗，在 4 例患者中进行了 LOT-CRT-P 治疗（I 组；n=105）。11 例瘢痕负荷≥10%的患者接受了 LBBP+ICD（II 组）。在平均 21±12 个月的随访期间，I 组 80%（68/85 例）患者达到 ER 主要终点，而 II 组仅为 27%（3/11 例）（P=.0001）。I 组主要复合终点（死亡、HFH 或 VT/VF）发生率为 3.8%，而 II 组为 33.3%（P<.0001）。I 组和 II 组的次要终点 EHR（LVEF≥50%）分别在 3、6 和 12 个月时观察到 39.5%、61.2%和 80%和 0%、9.1%和 33.3%。
结论
CMR 指导下使用 LOT-DDD-P 的 CRT 似乎是一种安全可行的 LB-NICM 治疗方法，有降低医疗成本的潜力。
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