Surgical myocardial revascularization is a safe, effective and well accepted treatment modality for severe coronary artery disease. Only recently has the medical community begun to appreciate that major as well as relatively minor complications of the procedure may have a significant and long lasting impact on the patients functional status. The principal objective of this randomized trial is to assess the safety and efficacy of two strategies of intra-operative hemodynamic management in preventing peri-operative cardiac, cognitive and non-cognitive neurologic morbidity and mortality and post-operative deterioration in the functional status of patients undergoing elective coronary artery revascularization (CABG). The study is a prospective trial of 248 patients who will be evaluated pre-operatively, monitored intra-operatively and followed post-operatively according to a standardized surveillance protocol. Patients will be randomized to two forms of hemodynamic management during cardiopulmonary bypass: in one group, the intra-operative MAP will be maintained between 80-100 mm Hg; in the second group, the intra-operative MAP will be maintained between 50-60 mm Hg. Both are standard, safe approaches to management. There are five principal outcomes: total mortality at 6 months, cardiopulmonary morbidity (i.e., myocardial infarction, pulmonary edema, cardiogenic shock/low flow state), cognitive complications (defined by intra-patient deterioration on psychometric test of memory, psychomotor function, and linguistic function), neurologic complications (new focal deficits, such as hemiplegia, dysphasia, cranial nerve lesions) and functional status (using the MOS index) at 6 months post-operatively. Impairment or improvement in physical and mental function at 6 months will also be documented using patient-specific transition indices that document changes in the patient's ability to engage in their usual activities. Changes in the MOS, Beck Depression Inventory, and in life stress and social integration will be assessed at baseline, 6 and 12 months. The long-term objective is to improve the quality of life and functional status after CABG. This study will define the impact of post-operative complications on functional status and determine whether different approaches to intra-operative hemodynamic management can reduce post-operative morbidity and prevent post-operative dysfunction.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project (R01)
Project #
1R01HL044719-01A1
Application #
3363537
Study Section
Human Development and Aging Subcommittee 3 (HUD)
Project Start
1991-08-01
Project End
1994-07-31
Budget Start
1991-08-01
Budget End
1992-07-31
Support Year
1
Fiscal Year
1991
Total Cost
Indirect Cost
Name
Weill Medical College of Cornell University
Department
Type
Schools of Medicine
DUNS #
201373169
City
New York
State
NY
Country
United States
Zip Code
10065
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Peterson, Janey C; Charlson, Mary E; Williams-Russo, Pamela et al. (2002) New postoperative depressive symptoms and long-term cardiac outcomes after coronary artery bypass surgery. Am J Geriatr Psychiatry 10:192-8
Charlson, M; Krieger, K H; Peterson, J C et al. (1999) Predictors and outcomes of cardiac complications following elective coronary bypass grafting. Proc Assoc Am Physicians 111:622-32
Pirraglia, P A; Peterson, J C; Williams-Russo, P et al. (1999) Depressive symptomatology in coronary artery bypass graft surgery patients. Int J Geriatr Psychiatry 14:668-80
Pirraglia, P A; Peterson, J C; Hartman, G S et al. (1998) The efficacy and safety of a pharmacologic protocol for maintaining coronary artery bypass patients at a higher mean arterial pressure during cardiopulmonary bypass. J Extra Corpor Technol 30:64-72
Hollenberg, J P; Pirraglia, P A; Williams-Russo, P et al. (1997) Computerized data collection in the operating room during coronary artery bypass surgery: a comparison to the hand-written anesthesia record. J Cardiothorac Vasc Anesth 11:545-51
Hartman, G S; Peterson, J; Konstadt, S N et al. (1996) High reproducibility in the interpretation of intraoperative transesophageal echocardiographic evaluation of aortic atheromatous disease. Anesth Analg 82:539-43
Hartman, G S; Yao, F S; Bruefach 3rd, M et al. (1996) Severity of aortic atheromatous disease diagnosed by transesophageal echocardiography predicts stroke and other outcomes associated with coronary artery surgery: a prospective study. Anesth Analg 83:701-8
Gold, J P; Charlson, M E; Williams-Russo, P et al. (1995) Improvement of outcomes after coronary artery bypass. A randomized trial comparing intraoperative high versus low mean arterial pressure. J Thorac Cardiovasc Surg 110:1302-11;discussion 1311-4

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