Biventricular pacing (BiVP) reverses intraventricular conduction delay (IVCD) and left ventricular (LV) dys- function in dilated cardiomyopathy (DCM). BiVP improves LV function and cardiac index (Cl) at no energy cost. The MIRACLE trial, in patients with DCM, IVCD and LV ejection fraction <35%, demonstrated improved subjective and objective measures of exercise tolerance and cardiac function with BiVP. BiVP benefits many, but selection criteria are not fully developed, and 30% of recipients are """"""""nonresponders,"""""""" at a cost of more than $2 billion/year. Preliminary data suggest that BiVP can benefit patients with low output states after cardiac surgery. We plan to assess surgical application of BiVP while assessing mechanisms of action and optimization. We will randomize 190 cardiac surgery patients with LV dysfunction preoperatively to paced and unpaced groups. BiVP will be optimized and continued postoperatively until patients are stable. BiVP will be assessed transiently in all patients at three time points. The primary end point is a 15% improvement in thermal dilution Cl measured in the intensive care unit (ICU). Effects of heart rate, atrioventricular delay, ventricular pacing site, and W timing on Cl will be assessed using a randomized sequence of data collection. Secondary end points include incidence of arrhythmias, inotropic support, urine output, weight gain, morbidity, mortality, and ICU costs. Related studies in three groups of 14 cardiac transplant recipients will assess BiVP effects on mechanics of in situ failing hearts with DCM or ischemic myopathy with or without inotropic support. The primary end point again is an increase in Cl, but each patient will undergo a randomized sequence of data collection for a 54-point matrix of six left ventricular pacing sites and nine W timings over 14 minutes, while measurements of Cl, contractility, intraventricular and interventricular synchrony and mitral regurgitation are recorded. Results will be displayed on two-dimensional response surfaces to define the best techniques for BiVP optimization. Patients with an increase in Cl <20% will be assessed in detail to determine the etiology of failure to respond. These studies are important because of a high probability of clinical benefit. The methods employed will provide precision, breadth of measurement, and range of pacing sites superior to any other setting. The protocol will provide new and important scientific information that will benefit not only surgical patients but also the general population of BiVP recipients.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project (R01)
Project #
3R01HL080152-03S1
Application #
7820947
Study Section
Bioengineering, Technology and Surgical Sciences Study Section (BTSS)
Program Officer
Sopko, George
Project Start
2009-06-01
Project End
2010-10-31
Budget Start
2009-06-01
Budget End
2010-10-31
Support Year
3
Fiscal Year
2009
Total Cost
$68,929
Indirect Cost
Name
Columbia University (N.Y.)
Department
Surgery
Type
Schools of Medicine
DUNS #
621889815
City
New York
State
NY
Country
United States
Zip Code
10032
Brusen, Robin M; Hahn, Rebecca; Cabreriza, Santos E et al. (2015) Wall Thickness, Pulmonary Hypertension, and Diastolic Filling Abnormalities Predict Response to Postoperative Biventricular Pacing. J Cardiothorac Vasc Anesth 29:1155-61
Wang, Alice; Cabreriza, Santos E; Cheng, Bin et al. (2014) Feasibility of speckle-tracking echocardiography for assessment of left ventricular dysfunction after cardiopulmonary bypass. J Cardiothorac Vasc Anesth 28:31-35
Havalad, Vinod; Cabreriza, Santos E; Cheung, Eva W et al. (2014) Optimized multisite ventricular pacing in postoperative single-ventricle patients. Pediatr Cardiol 35:1213-9
Spotnitz, Henry M; Cabreriza, Santos E; Wang, Daniel Y et al. (2013) Primary endpoints of the biventricular pacing after cardiac surgery trial. Ann Thorac Surg 96:808-15
Wang, Alice; Cabreriza, Santos E; Quinn, T Alexander et al. (2013) Regional and global strain changes during biventricular pacing in a porcine model of acute left ventricular volume overload. J Ultrasound Med 32:675-82
Wang, Alice; Cabreriza, Santos E; Havalad, Vinod et al. (2013) Effects of biventricular pacing on left heart twist and strain in a porcine model of right heart failure. J Surg Res 185:645-52
Lu, Jiajie G; Pensiero, Anthony; Aponte-Patel, Linda et al. (2013) Short-term reduction in intrinsic heart rate during biventricular pacing after cardiac surgery: a substudy of a randomized clinical trial. J Thorac Cardiovasc Surg 146:1494-500
Nguyen, Huy V; Havalad, Vinod; Aponte-Patel, Linda et al. (2013) Temporary biventricular pacing decreases the vasoactive-inotropic score after cardiac surgery: a substudy of a randomized clinical trial. J Thorac Cardiovasc Surg 146:296-301
Rusanov, Alexander; Wang, Daniel Y; Cabreriza, Santos E et al. (2012) Effect of atrioventricular conduction prolongation on optimization of paced atrioventricular delay for biventricular pacing after cardiac surgery. J Cardiothorac Vasc Anesth 26:209-16
Rubinstein, Benjamin J; Wang, Daniel Y; Cabreriza, Santos E et al. (2012) Response of mean arterial pressure to temporary biventricular pacing after chest closure during cardiac surgery. J Thorac Cardiovasc Surg 144:1445-52

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