Improving Outcomes

For the last 15 years, our research team has developed prognostic models for identifying patients at high risk of adverse events. Based on those models, we have developed and evaluated innovative strategies for improving outcomes in randomized trials. Our research has resulted in significant improvements in outcomes of patients with coronary artery disease, hypertension, asthma, and orthopedic surgery patients.

1.1 Cardiothoracic surgery

Perfusion is maintained in regional circulations in an individual's autoregulatory range, usually about 20 mm around their usual mean arterial pressure. Our prospective studies demonstrated that general and vascular surgery patients, whose intra-operative blood pressure dropped more than 20 mm Hg below their usual autoregulatory range, had significantly increased risk of major post-operative morbidity. This led us to develop new strategies for managing the blood pressure of patients during cardiopulmonary bypass and new methods of identifying patients at the highest risk.

Current Research

1. Network for Cardiothoracic Surgical Investigations in Cardiovascular Medicine (Co-Investigators: Mary Charlson, MD, Janey Peterson, EdD, James Hollenberg MD, Martin Wells, PhD, NIH/NHLBI, $903,652, 2007-2012)

NHLBI awarded a $23 million grant for a Data Coordinating Center to Drs. Gelijins and Parides, now based at Mt. Sinai, for a Cardiothoracic Surgery Investigations Network. This 8 site network enables research teams led by cardiac surgeons to develop and conduct multiple collaborative proof-of-concept clinical studies and interventional protocols to improve cardiovascular disease outcomes. Cornell brings expertise in trial design, trial coordination, data management, quality assurance and monitoring, statistical and analytical support. Quality of life outcomes, and the methodology and definitions of cognitive decline have been a special focus of our work. Dr. Janey Peterson and Dr. Martin Wells have worked with the Neurocognitive Committee to develop valid and reliable scales as well as a method of analysis of neurocognitive test batteries that will be used in all U01-funded trials. Dr. Hollenberg has developed a web based system to track infectious complications.

Past Research

1. Improvement of outcomes after coronary artery bypass: A randomized trial comparing intraoperative high versus low mean arterial pressure (PI: Mary Charlson, MD, James Hollenberg, MD, Janey Peterson, EdD, NHLBI, $1,400,000)

Our first trial in coronary artery bypass graft (CABG) patients compared maintaining mean arterial pressure (MAP) at the customary level of approximately 50-60 mm Hg to maintaining bypass MAP at a higher level (80-90 mm Hg) in 248 patients. The high MAP group had a significantly lower rate of cardiac and neurologic complications: 4.8% vs. 12.9% of the low MAP group (p=.026). There were no differences in cognitive or functional outcomes. We also found that TEE grade was an extraordinarily important predictor of risk of post-operative stroke; data from our first trial showed a dramatic relationship between grade V atheroma and stroke rates, with 2% of those with grade I-III but 45% of those with grade V having a major stroke. Patients with severe aortic atheromatous disease (grade V) who had higher MAPs during CPB had lower stroke rates; the strokes were major (i.e., hemiplegia, cortical blindness). In fact the stroke rate differences--20% vs. 67%--were so stark that the use of lower MAPs in grade V patients was viewed as ethically prohibited. Today all grade IV-V patients are run at higher MAPs during CPB.

2. Improvement of outcomes after coronary artery bypass II: A randomized trial comparing intra-operative high versus customized mean arterial pressure (PI: Mary Charlson, MD, James Hollenberg, MD, Janey Peterson, EdD, NHLBI)

The second trial in 412 elective CABG patients compared the rate of combined cardiac, neurologic, cognitive and quality of life outcomes between "high MAP," defined as 80 mm Hg, to "custom MAP" determined by the patient's usual pre-operative MAP; thus the second group had a customized, patient-specific MAP target. The cardiac and neurologic event rates did not differ: 11.6% for the high MAP group and 12.1% for the custom MAP group. There were no differences between the groups in cognitive or functional outcomes. Therefore, tailoring the MAP to the patients' usual MAP did not reduce the cardiac, neurologic, cognitive, and functional complications more than the use of a target of 80 mm Hg.

3. Assessing Cognitive change after surgery (NIA and AHRQ)

For the past two decades, research in the field of neurocognition following coronary artery bypass surgery has focused on predictors of neurocognitive decline following cardiopulmonary bypass and what "actual" levels of neurocognitive injury resulted from surgery. Cognitive deterioration has been reported to occur in up to 1/3 of CABG patients and is usually attributed to who had cardiopulmonary bypass. We developed a neuropsychological battery testing three domains: memory, language and psychomotor function. We defined cognitive changes as deterioration on 3 or more of the ten tests at six months after surgery. By this criteria, only 7.2% of CABG patients demonstrated cognitive deterioration at six months after surgery - identical to the deterioration rates in hip or knee replacement patients. If the usual definition of cognitive deterioration was used, then 33% of patients with hip or knee replacement would have had post-operative cognitive deterioration. These methods used to define deterioration in CABG patients, have vastly inflated the rate of cognitive complications.


1.2 Glaucoma

The theory of autoregulation of regional circulations that provided the framework for our trials in coronary artery patients has also provided the foundation for a current study funded by NEI to evaluate a new theory about the cause of visual field loss in normal tension glaucoma. Specifically, we believe that visual field loss is caused by systemic hypotension rather than elevated intraocular pressure.

Current Research

1. Autoregulation & Systemic Blood Pressure: A New View of Normal Tension Glaucoma (PI: Mary Charlson, MD, NIH/NEI, $457,402)

Among 85 patients with normal tension glaucoma, that is, patients who have visual field deficits with normal intraocular pressures {i.e., <21 mm Hg} without treatment, the principal objective of this prospective longitudinal pilot study is to determine whether patients who have nocturnal ambulatory blood pressures more than 20 mm Hg below their autoregulatory range have greater risk for visual field loss over 12 months of follow up when compared to patients whose blood pressure is maintained within the autoregulatory range. Visual field loss is assessed by longitudinal, within-patient changes in confocal laser scanning tomography optical coherence tomography, stereo optic disc photographs and visual fields performed at 6 and 12 months. This study will determine whether a larger prospective cohort study should be undertaken and help to define the optimal monitoring strategies


1.3 Coronary artery patients (post angioplasty and post MI)

Our research team has been working for over a decade to develop strategies to motivate patients with coronary artery disease to initiate and sustain healthy behaviors, including increasing physical activity, healthy eating, reducing weight, stopping smoking, and controlling blood pressure. Such behavioral and lifestyle changes in patients with coronary artery disease can significantly reduce secondary events, but such lifestyle changes are rarely achieved.

Current Research

1. Determinants of Cardiac Risk Factor Modification- Minority Faculty Development Award (PI: Carla Boutin-Foster, MD, MS, NIH/NHLBI, $606,416; 2004-2009)

Among 213 Latino adult patients who have had coronary artery angioplasty, the specific aims of the study are to determine whether patients who have more depressive symptoms at the time of angioplasty will be less physically active at two years and to determine whether lower perceived social support, lower self-efficacy for engaging in physical activity, and greater perceived stress mediate the effects of depressive symptoms on participation in physical activity. The data is currently being analyzed.

2. Depressive Symptoms in Overweight or Obese Latino Adults after myocardial infarction (K01 NHLBI -HL076567 PI: Carla Boutin Foster, MD, MS)

This study evaluated the psychosocial correlates of being overweight or obese among Latino adults. Of the 177 participants, 64% were overweight or obese and 51% experienced coexisting depressive symptoms. On univariate analyses, overweight or obese participants with depressive symptoms were more likely to be younger (OR =2.4), female (OR =2.5), rate their health as fair or poor (OR =3.8), and to report high perceived stress (OR =7.8). In multivariate analysis, coexisting depressive symptoms and excess weight was significantly associated with greater perceived stress (OR = 6.5). In this cohort of Latino adults there is a strong association between having excess weight and experiencing depressive symptoms and perceived stress.

Past Research

1. Improving Health Behavior and Outcomes after Angioplasty (PI: Mary Charlson, MD, NHLBI, R01 HL62161, 1999-2003, $2,830,387)

This NHLBI RO1-funded randomized trial evaluated two approaches to framing health-risk information (present value vs. future value) in improving outcomes among 660 patients who have just undergone angioplasty. There were no differences in two year outcomes between the groups; 37% in the future value and 32% in the present value had major cardiovascular morbidity.

2. The impact of the doctor-patient relationship on the outcomes of patients with cardiac disease (PI: Carla Boutin-Foster, MD, MIRS, NHLBI, 1999-2004, $200,000)

The goal of this study was to evaluate the impact of attributes of the doctor-patient relationship on outcomes of patients who have undergone angioplasty. This study suggested that interventions focusing on enhancing trust and improving physicians' interpersonal skills may also promote behavioral change among patients with coronary artery disease. Women had more depressive symptoms (P = .01) and lower ratings of self-efficacy (P = .001) compared to men. Lower self-efficacy and greater depressive symptoms emerged as mediators in the relationship between gender and maintenance of weight loss.

3. Improving quality of life after myocardial infarction: The impact of social support (PI: Carla Boutin-Foster, MD, MS. RWJ Minority Faculty Development Fellowship Grant, 2001-2005, $338,333)

Among patients hospitalized for a myocardial infarction, the objective of this prospective study was to determine the impact of social support on functional outcomes at two years. Interactions with family members, friends, and health professionals can provide three types of positive and negative support: emotional, informational, and instrumental (tangible). The common themes underlying these positive or helpful acts of social support included encouraging healthy behaviors, providing access to care, and facilitating adherence. The common themes underlying negative or unhelpful acts of social support included promoting a sense of loss of control and making patients feel more vulnerable.

4. Depression, Self-efficacy and Adherence in Angioplasty Patients (Co-Investigator: Godwin Ogedegbe, MD, Minority supplement award to NHLBI 1RO1 HL62161-01, 2001-2002. PI: Mary Charlson, MD)

The goal of this supplement was to determine and characterize the relationship between depressive symptoms, self-efficacy and adherence to recommended health behaviors in 182 coronary artery disease patients who recently had angioplasty. Patients who were depressed had lower self-efficacy and were less likely to make and sustain behavior changes.


CONTACT US

Division of Clinical Epidemiology and Evaluative Sciences Research
Mary E. Charlson, MD, Chief

Suzan Toro, Administrator
338 East 66th Street
Tel: 646-962-5060
Fax: 646-962-0620
ssamuel@med.cornell.edu

CLINICAL TRIALS

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