Medizinische Klinik für Kardiologie, Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin, Hindenburgdamm 30, 12203 Berlin, Germany.
Heart and Vascular Center, Semmelweis Medical University, Városmajorutca 68, 1122 Budapest, Hungary.
Europace. 2021 Nov 8;23(11):1777-1786. doi: 10.1093/europace/euab110.
Clinical effects of rate-adaptive pacing in heart failure patients with chronotropic incompetence (CI) undergoing cardiac resynchronization therapy (CRT) remain unclear. Closed loop stimulation (CLS) is a new rate-adaptive sensor in CRT devices. We evaluated the effectiveness of CLS in CRT patients with severe CI, focusing primarily on key prognostic variables assessed by cardiopulmonary exercise (CPX) testing.
In the randomized, crossover, multicentre BIO|CREATE study, 20 CRT patients with severe CI and NYHA Class II/III (60%/40%) were randomized 1:1 to the sequence DDD-40 mode to DDD-CLS mode, or the sequence DDD-CLS mode to DDD-40 mode (1 month in each mode). Patients underwent symptom-limited treadmill-based CPX test in each mode. An improvement (decrease) of the ventilatory efficiency (VE) slope of ≥5% during CLS was regarded as positive response to CLS. Seventeen patients with full data sets had a mean intra-individual VE slope change of -1.8 ± 3.0 (-4.1%) with CLS (P = 0.23). Eight patients (47%) were CLS responders, with a -6.1 ± 2.7 (-16.4%) slope change (P = 0.029). Compared to non-responders, CLS responders had a higher left ventricular (LV) ejection fraction (46 ± 3 vs. 36 ± 9%; P = 0.0070), smaller end-diastolic LV volume (121 ± 34 vs. 181 ± 41 mL; P = 0.0085), smaller end-systolic LV volume (65 ± 23 vs. 114 ± 39 mL; P = 0.0076), and were predominantly in NYHA Class II (P = 0.0498).
The data of the present pilot study are compatible with the notion that CLS activation may improve VE slope in CRT patients with severe CI and less advanced heart failure. Further research is needed to determine the long-term clinical outcomes of CLS.
在接受心脏再同步治疗（CRT）的慢性节律失能（CI）心力衰竭患者中，速率适应性起搏的临床效果仍不清楚。闭环刺激（CLS）是 CRT 设备中的一种新型速率适应性传感器。我们评估了 CLS 在严重 CI 的 CRT 患者中的有效性，主要侧重于心肺运动（CPX）测试评估的关键预后变量。
在随机、交叉、多中心的 BIO|CREATE 研究中，20 例严重 CI 且 NYHA 心功能分级 II/III（60%/40%）的 CRT 患者按 1:1 随机分为 DDD-40 模式至 DDD-CLS 模式组，或 DDD-CLS 模式至 DDD-40 模式组（每组各 1 个月）。患者在每种模式下均进行症状限制的跑步机 CPX 测试。CLS 时 VE 斜率增加（降低）≥5%被认为是对 CLS 的阳性反应。17 例具有完整数据集的患者在 CLS 时的平均个体 VE 斜率变化为-1.8±3.0（-4.1%）（P=0.23）。8 例（47%）患者为 CLS 反应者，斜率变化为-6.1±2.7（-16.4%）（P=0.029）。与非反应者相比，CLS 反应者的左心室（LV）射血分数更高（46±3%比 36±9%；P=0.0070），LV 舒张末期容积更小（121±34 比 181±41mL；P=0.0085），LV 收缩末期容积更小（65±23 比 114±39mL；P=0.0076），且主要处于 NYHA 心功能分级 II 级（P=0.0498）。
本初步研究的数据与 CLS 激活可能改善严重 CI 和心力衰竭程度较低的 CRT 患者 VE 斜率的观点一致。需要进一步研究以确定 CLS 的长期临床结局。
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