Henry M. Spotnitz, MD, Santos E. Cabreriza, MBA, Daniel Y. Wang, MD, T

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Presentation transcript:

Primary Endpoints of the Biventricular Pacing After Cardiac Surgery Trial Henry M. Spotnitz, MD, Santos E. Cabreriza, MBA, Daniel Y. Wang, MD, T. Alexander Quinn, PhD, Bin Cheng, PhD, Lauren N. Bedrosian, BA, Linda Aponte-Patel, MD, Craig R. Smith, MD The Annals of Thoracic Surgery Volume 96, Issue 3, Pages 808-815 (September 2013) DOI: 10.1016/j.athoracsur.2013.04.101 Copyright © 2013 The Society of Thoracic Surgeons Terms and Conditions

Fig 1 Biventricular Pacing after Cardiac Surgery trial protocol. Pacing was optimized 1 hour after weaning from bypass (phase I), 1 hour later after chest closure (phase II), and on the day after (phase III). Patients were randomized after phase I. Optimization included 7 atrioventricular delays, 6 LV lead locations, and 9 interventricular delays. Each parameter was tested for 10 (phase I), 20 (phase II), or 30 seconds (phase III) in duplicate and random sequence. Optimization parameters: aortic flow in phase I, mean arterial pressure in phase II, and mean arterial pressure followed by cardiac index in phase III. Primary endpoint: thermal dilution cardiac index prior to phase III. (BiVP = biventricular pacing; CI = cardiac index; CO = cardiac output; CPB = cardiopulmonary bypass; ICU = intensive care unit; MAP = mean arterial pressure; SOC = standard of care; TD = tricuspid dysplasia.) The Annals of Thoracic Surgery 2013 96, 808-815DOI: (10.1016/j.athoracsur.2013.04.101) Copyright © 2013 The Society of Thoracic Surgeons Terms and Conditions

Fig 2 Biventricular Pacing after Cardiac Surgery trial epicardial temporary pacing sites. (A) Anterior view. (B) Posterior view. (Circ = circumflex; IL = inferolateral; IM = inferomedial; OM = obtuse margin; PDA = posterior descending artery; RA = right atrium; RV = right ventricle; All locations except for RA and RV are left ventricular (LV) pacing sites; black labelled LV sites are LV1 group; yellow labels identify LV2 group.) The Annals of Thoracic Surgery 2013 96, 808-815DOI: (10.1016/j.athoracsur.2013.04.101) Copyright © 2013 The Society of Thoracic Surgeons Terms and Conditions

Fig 3 Biventricular Pacing after Cardiac Surgery trial recruitment was terminated for slow accrual on February 29, 2012. (STEPS = speckle tracking echocardiography post surgery trial; UCLA = University of California at Los Angeles.) The Annals of Thoracic Surgery 2013 96, 808-815DOI: (10.1016/j.athoracsur.2013.04.101) Copyright © 2013 The Society of Thoracic Surgeons Terms and Conditions

Fig 4 Biventricular Pacing after Cardiac Surgery trial patient flow. Enrollment was 111 of 6,346 screened. Sixty-one were randomized. Primary endpoints were obtained in 47. (AVR/MVR = combined aortic and mitral valve surgery; BiVP = biventricular pacing group; SOC = standard of care group.) The Annals of Thoracic Surgery 2013 96, 808-815DOI: (10.1016/j.athoracsur.2013.04.101) Copyright © 2013 The Society of Thoracic Surgeons Terms and Conditions

Fig 5 Cardiac index endpoint is 12% higher in all BiVP patients, not statistically significant. In the AVR subgroup CI is 60% higher (p = 0.018). (ALL = all patients; AVR = aortic valve surgery; AVR/MVR = combined aortic and mitral surgery; BiVP = biventricular pacing; CABG = coronary artery bypass; CI = cardiac index; MVR = mitral valve surgery; SOC = standard of care.) The Annals of Thoracic Surgery 2013 96, 808-815DOI: (10.1016/j.athoracsur.2013.04.101) Copyright © 2013 The Society of Thoracic Surgeons Terms and Conditions

Fig 6 Combined aortic valve and aortic and mitral valve surgery subgroup. Cardiac index is 29% higher with biventricular pacing. (BiVP = biventricular pacing; SOC = standard of care.) The Annals of Thoracic Surgery 2013 96, 808-815DOI: (10.1016/j.athoracsur.2013.04.101) Copyright © 2013 The Society of Thoracic Surgeons Terms and Conditions

Fig 7 Linear effects model t test reveals mean arterial pressure increase with optimized biventricular pacing versus no pacing in all patients. (AAI = atrial pacing; BiVP = biventricular pacing; NoP = no pacing.) The Annals of Thoracic Surgery 2013 96, 808-815DOI: (10.1016/j.athoracsur.2013.04.101) Copyright © 2013 The Society of Thoracic Surgeons Terms and Conditions