Wales Heart Research Institute, Heath Park, Cardiff, CF14 4XN, UK.
Trials. 2012 Feb 20;13:20. doi: 10.1186/1745-6215-13-20.
Heart failure patients with stable angina, acute coronary syndromes and valvular heart disease may benefit from revascularisation and/or valve surgery. However, the mortality rate is increased- 5-30%. Biventricular pacing using temporary epicardial wires after surgery is a potential mechanism to improve cardiac function and clinical endpoints.
METHOD/DESIGN: A multi-centred, prospective, randomised, single-blinded, intervention-control trial of temporary biventricular pacing versus standard pacing. Patients with ischaemic cardiomyopathy, valvular heart disease or both, an ejection fraction ≤ 35% and a conventional indication for cardiac surgery will be recruited from 2 cardiac centres. Baseline investigations will include: an electrocardiogram to confirm sinus rhythm and measure QRS duration; echocardiogram to evaluate left ventricular function and markers of mechanical dyssynchrony; dobutamine echocardiogram for viability and blood tests for renal function and biomarkers of myocardial injury- troponin T and brain naturetic peptide. Blood tests will be repeated at 18, 48 and 72 hours. The principal exclusions will be subjects with permanent atrial arrhythmias, permanent pacemakers, infective endocarditis or end-stage renal disease.After surgery, temporary pacing wires will be attached to the postero-lateral wall of the left ventricle, the right atrium and right ventricle and connected to a triple chamber temporary pacemaker. Subjects will be randomised to receive either temporary biventricular pacing or standard pacing (atrial inhibited pacing or atrial-synchronous right ventricular pacing) for 48 hours.The primary endpoint will be the duration of level 3 care. In brief, this is the requirement for invasive ventilation, multi-organ support or more than one inotrope/vasoconstrictor. Haemodynamic studies will be performed at baseline, 6, 18 and 24 hours after surgery using a pulmonary arterial catheter. Measurements will be taken in the following pacing modes: atrial inhibited; right ventricular only; atrial synchronous-right ventricular; atrial synchronous-left ventricular and biventricular pacing. Optimisation of the atrioventricular and interventricular delay will be performed in the biventricular pacing group at 18 hours. The effect of biventricular pacing on myocardial injury, post operative arrhythmias and renal function will also be quantified.
ClinicalTrials.gov: NCT01027299.
患有稳定型心绞痛、急性冠脉综合征和心脏瓣膜病的心力衰竭患者可能从血运重建和/或瓣膜手术中获益。然而，死亡率增加了 5%-30%。手术后使用临时心外膜导线进行双心室起搏是改善心功能和临床终点的潜在机制。
方法/设计：这是一项多中心、前瞻性、随机、单盲、干预对照试验，比较临时双心室起搏与标准起搏。从 2 个心脏中心招募缺血性心肌病、心脏瓣膜病或两者兼有、射血分数≤35%和常规心脏手术指征的患者。基线研究包括：心电图以确认窦性节律和测量 QRS 时限；超声心动图以评估左心室功能和机械不同步的标志物；多巴酚丁胺超声心动图以评估存活能力以及肾功能和心肌损伤标志物-肌钙蛋白 T 和脑钠肽的血液检查。血液检查将在 18、48 和 72 小时重复进行。主要排除标准为患有永久性房性心律失常、永久性起搏器、感染性心内膜炎或终末期肾病的患者。手术后，将临时起搏导线连接到左心室后外侧壁、右心房和右心室，并连接到三腔临时起搏器。患者将被随机分配接受临时双心室起搏或标准起搏（心房抑制起搏或心房同步右心室起搏）48 小时。主要终点是 3 级护理的持续时间。简单来说，这是需要有创通气、多器官支持或以上一种正性肌力药/血管收缩药的要求。在手术后 6、18 和 24 小时使用肺动脉导管进行血流动力学研究。将在以下起搏模式下进行测量：心房抑制；仅右心室；心房同步-右心室；心房同步-左心室和双心室起搏。将在 18 小时时在双心室起搏组中优化房室和室间延迟。还将量化双心室起搏对心肌损伤、术后心律失常和肾功能的影响。
ClinicalTrials.gov：NCT01027299。
