University Medical Centre Ljubljana, Slovenia.
EuroIntervention. 2021 Aug 27;17(6):466-473. doi: 10.4244/EIJ-D-21-00348.
Despite primary PCI (PPCI), ST-elevation myocardial infarction (STEMI) can still result in large infarct size (IS). New technology with rapid intravascular cooling showed positive signals for reduction in IS in anterior STEMI.
We investigated the effectiveness and safety of rapid systemic intravascular hypothermia as an adjunct to PPCI in conscious patients, with anterior STEMI, without cardiac arrest.
Hypothermia was induced using the ZOLL® Proteus™ intravascular cooling system. After randomisation of 111 patients, 58 to hypothermia and 53 to control groups, the study was prematurely discontinued by the sponsor due to inconsistent patient logistics between the groups resulting in significantly longer total ischaemic delay in the hypothermia group (232 vs 188 minutes; p<0.001).
There were no differences in angiographic features and PPCI result between the groups. Intravascular temperature at wire crossing was 33.3+0.9°C. Infarct size/left ventricular (IS/LV) mass by cardiac magnetic resonance (CMR) at day 4-6 was 21.3% in the hypothermia group and 20.0% in the control group (p=0.540). Major adverse cardiac events at 30 days increased non-significantly in the hypothermia group (8.6% vs 1.9%; p=0.117) while cardiogenic shock (10.3% vs 0%; p=0.028) and paroxysmal atrial fibrillation (43.1% vs 3.8%; p<0.001) were significantly more frequent in the hypothermia group.
The ZOLL Proteus intravascular cooling system reduced temperature to 33.3°C before PPCI in patients with anterior STEMI. Due to inconsistent patient logistics between the groups, this hypothermia protocol resulted in a longer ischaemic delay, did not reduce IS/LV mass and was associated with increased adverse events.
尽管进行了直接经皮冠状动脉介入治疗（PPCI），ST 段抬高型心肌梗死（STEMI）仍可能导致大面积梗死（IS）。具有快速血管内冷却功能的新技术在前壁 STEMI 中显示出减少 IS 的积极信号。
我们研究了在无心脏骤停的清醒前壁 STEMI 患者中，将快速全身血管内低温作为 PPCI 的辅助手段的有效性和安全性。
使用 ZOLL®Proteus™血管内冷却系统诱导低温。在随机分配的 111 名患者中，58 名接受低温治疗，53 名接受对照组治疗后，由于两组之间的患者物流不一致，导致低温组的总缺血延迟时间明显延长（232 分钟比 188 分钟；p<0.001），因此研究由赞助商提前终止。
两组之间的血管造影特征和 PPCI 结果没有差异。导丝交叉处的血管内温度为 33.3+0.9°C。第 4-6 天行心脏磁共振（CMR）检查的梗死面积/左心室（IS/LV）质量在低温组为 21.3%，对照组为 20.0%（p=0.540）。30 天时低温组的主要不良心脏事件增加，但无统计学意义（8.6%比 1.9%；p=0.117），而心源性休克（10.3%比 0%；p=0.028）和阵发性心房颤动（43.1%比 3.8%；p<0.001）在低温组更常见。
ZOLL Proteus 血管内冷却系统在前壁 STEMI 患者中，在 PPCI 前将温度降低至 33.3°C。由于两组之间的患者物流不一致，该低温方案导致缺血时间延长，并未减少 IS/LV 质量，且与不良事件增加相关。
