Robert A. Clough

A regional intervention to improve the hospital mortality associated with coronary artery bypass graft surgery. The Northern New England Cardiovascular Disease Study Group.

OBJECTIVE To determine whether an organized intervention including data feedback, training in continuous quality improvement techniques, and site visits to other medical centers could improve the hospital mortality rates associated with coronary artery bypass graft (CABG) surgery. DESIGN Regional intervention study. Patient demographic and historical data, body surface area, cardiac catheterization results, priority of surgery, comorbidity, and status at hospital discharge were collected on CABG patients in Northern New England between July 1, 1987, and July 31, 1993. SETTING This study included all 23 cardiothoracic surgeons practicing in Maine, New Hampshire, and Vermont during the study period. PATIENTS Data were collected on 15,095 consecutive patients undergoing isolated CABG procedures in Maine, New Hampshire and Vermont during the study period. INTERVENTIONS A three-component intervention aimed at reducing CABG mortality was fielded in 1990 and 1991. The interventions included feedback of outcome data, training in continuous quality improvement techniques, and site visits to other medical centers. MAIN OUTCOME MEASURE A comparison of the observed and expected hospital mortality rates during the postintervention period. RESULTS During the postintervention period, we observed the outcomes for 6488 consecutive cases of CABG surgery. There were 74 fewer deaths than would have been expected. This 24% reduction in the hospital mortality rate was statistically significant (P = .001). This reduction in mortality rate was relatively consistent across patient subgroups and was temporally associated with the interventions. CONCLUSION We conclude that a multi-institutional, regional model for the continuous improvement of surgical care is feasible and effective. This model may have applications in other settings.

Survival of patients with diabetes and multivessel coronary artery disease after surgical or percutaneous coronary revascularization: results of a large regional prospective study

OBJECTIVES We sought to assess survival among patients with diabetes and multivessel coronary artery disease (MVD) after percutaneous coronary intervention (PCI) and after coronary artery bypass grafting surgery (CABG). BACKGROUND The Bypass Angioplasty Revascularization Investigation (BARI) demonstrated that diabetics with MVD survive longer after initial CABG than after initial PCI. Other randomized trials or observational databases have not conclusively reproduced this result. METHODS A large, regional database was linked to the National Death Index to assess five-year mortality. Of 7,159 consecutive patients with diabetes who underwent coronary revascularization in northern New England during 1992 to 1996, 2,766 (38.6%) were similar to those randomized in the BARI trial. Percutaneous coronary intervention was the initial revascularization strategy in 736 patients and CABG in 2,030. Cox proportional hazards regression was used to calculate risk-adjusted hazard ratios (HR) and 95% confidence intervals (CI 95%). RESULTS Patients who underwent PCI were younger, had higher ejection fractions and less extensive coronary disease. After adjusting for differences in baseline clinical characteristics, patients with diabetes treated with PCI had significantly greater mortality relative to those undergoing CABG (HR = 1.49; CI 95%: 1.02 to 2.17; p = 0.037). Mortality risk tended to increase more among 1,251 patients with 3VD (HR = 2.02; CI 95%: 1.04 to 3.91; p = 0.038) than among 1,515 patients with 2VD (HR = 1.33; CI 95%: 0.84 to 2.1; p = 0.21). CONCLUSIONS In this analysis of a large regional contemporary database of patients with diabetes selected to be similar to those enrolled in the BARI trial, five-year mortality was significantly increased after initial PCI. This supports the BARI conclusion on initial revascularization of patients with diabetes and MVD.

The association of perioperative red blood cell transfusions and decreased long-term survival after cardiac surgery.

BACKGROUND: Exposure to red blood cell (RBC) transfusions has been associated with increased mortality after cardiac surgery. We examined long-term survival for cardiac surgical patients who received one or two RBC units during index hospitalization. METHODS: Nine thousand seventy-nine consecutive patients undergoing coronary artery bypass graft, valve, or coronary artery bypass graft/valve surgery at eight centers in northern New England during 2001-2004 were examined after exclusions. A probabilistic match between the regional registry and the Social Security Administration’s Death Master File determined mortality through June 30, 2006. Cox Proportional Hazard and propensity methods were used to calculate adjusted hazard ratios. RESULTS: Thirty-six percent of patients (n = 3254) were exposed to one or two RBC units. Forty-three percent of RBCs were given intraoperatively, 56% in the postoperative period and 1% were preoperative. Patients transfused were more likely to be anemic, older, smaller, female and with more comorbid illness. Survival was significantly decreased for all patients exposed to 1 or 2 U of RBCs during hospitalization for cardiac surgery compared with those who received none (P < 0.001). After adjustment for patient and disease characteristics, patients exposed to 1 or 2 U of RBCs had a 16% higher long-term mortality risk (adjusted hazard ratios = 1.16, 95% CI: 1.01-1.34, P = 0.035). CONCLUSIONS: Exposure to 1 or 2 U of RBCs was associated with a 16% increased hazard of decreased survival after cardiac surgery.

Risks of Morbidity and Mortality in Dialysis Patients Undergoing Coronary Artery Bypass Surgery

Background—Although dialysis patients are undergoing CABG with increasing frequency, large studies specifically comparing patient characteristics and procedure-related risks in this population have not been performed. Methods and Results—We conducted a regional prospective cohort study of 15 500 consecutive patients undergoing CABG in northern New England from 1992 to 1997. We used multiple logistic regression analysis to examine associations between preoperative dialysis-dependent renal failure and postoperative events and to adjust for potentially confounding variables. The 279 dialysis-dependent renal failure patients (1.8%) were 4.4 times more likely to experience in-hospital mortality than were other CABG patients (12.2% versus 3.0%, respectively;P <0.001). Dialysis-dependent renal failure patients were older and had more comorbidities and more severe cardiac disease than did other CABG patients. After adjusting for these factors in multivariate analysis, however, dialysis-dependent renal failure patients remained 3.1 times more likely to die after CABG (adjusted odds ratio [OR] 3.1, 95% CI 2.1 to 4.7;P <0.001). Dialysis-dependent renal failure patients compared with other CABG patients also had a substantially increased risk of postoperative mediastinitis (3.6% versus 1.2%, respectively; adjusted OR 2.4, 95% CI 1.2 to 4.7;P =0.011) and postoperative stroke (4.3% versus 1.7%, respectively; adjusted OR 2.1, 95% CI 1.1 to 3.9;P =0.016), even after controlling for potentially confounding variables. Risks of reexploration for bleeding were similar for patients with and without dialysis-dependent renal failure. Conclusions—Preoperative dialysis-dependent renal failure is a strong independent risk factor for in-hospital mortality and mediastinitis after CABG.

Mediastinitis and long-term survival after coronary artery bypass graft surgery

BACKGROUND Mediastinitis is a dreaded complication of coronary artery bypass surgery (CABG). The long-term effect of mediastinitis on mortality after CABG has not been well studied. METHODS We examined the survival of 15,406 consecutive patients undergoing isolated CABG surgery from 1992 through 1996. Patient records were linked to the National Death Index. Mediastinitis was defined as occurring during the index admission and requiring reoperation. RESULTS Mediastinitis occurred in 193 patients (1.25%). Patients with mediastinitis were older and more likely to have had emergency surgery, diabetes, peripheral vascular disease, chronic obstructive pulmonary disease, and preoperative dialysis-dependent renal failure. Patients with mediastinitis were also more likely to be severely obese and had somewhat lower preoperative ejection fraction. After multivariate adjustment for these factors, the first year post-CABG survival rate was 78% with mediastinitis and 95% without, and the hazard ratio for mortality during the entire follow-up period was 3.09 (CI 95% 2.28, 4.19; p < 0.0001). CONCLUSIONS Mediastinitis is associated with a marked increase in mortality during the first year post-CABG and a threefold increase during a 4-year follow-up period.

In-hospital outcomes of off-pump versus on-pump coronary artery bypass procedures: a multicenter experience ☆

BACKGROUND Concern about the possible adverse effects of the cardiopulmonary bypass (CPB) pump and advances in retractors and operative techniques to access all coronary segments have resulted in increased interest in off-pump coronary artery bypass (OPCAB) procedures. Four of the Northern New England Cardiovascular Disease Study Group centers initiated OPCAB programs in 1998. We compared the preoperative risk profiles and in-hospital outcomes of patients done off-pump with those done by conventional coronary artery bypass (CCAB) with CPB. METHODS Between 1998 and 2000, 1,741 OPCAB and 6,126 CCAB procedures were performed at these four medical centers. Minimally invasive direct coronary artery bypass grafting procedures were excluded. Data were available for patient and disease risk factors, extent of coronary disease and adverse in-hospital outcomes. RESULTS The OPCAB and CCAB groups were somewhat different in their preoperative patient and disease characteristics. The OPCAB patients were more likely to be female and to have peripheral vascular disease. The CCAB patients were more likely to have an ejection fraction less than 0.40 and be urgent or emergent at operation. However, overall predicted risk of in-hospital mortality, based on preoperative factors, was similar in the OPCAB and CCAB groups; the mean predicted risk was 2.6% (p = 0.567). Crude rates of mortality (2.54% OPCAB versus 2.57%, CCAB), intraoperative or postoperative stroke (1.33% versus 1.82%), mediastinitis (1.10% versus 1.37%), and return to the operating room for bleeding (3.46% versus 2.93%) did not differ significantly. The OPCAB patients did have a statistically significant reduction in the need for intraoperative or postoperative intraaortic balloon pump support (2.31% versus 3.41%; p = 0.023) and in the incidence of postoperative atrial fibrillation (21.21% versus 26.31%; p < 0.001). Adjustment for preoperative risk factors and extent of coronary disease did not substantially change the crude results. Median postoperative length of stay was significantly shorter (5 days versus 6 days, p < 0.001) for OPCAB patients than for CCAB patients. CONCLUSIONS This multicenter study showed that patients having OPCAB are not exposed to a greater risk of short-term adverse outcomes. These data also provided evidence that patients having OPCAB have significantly lower need for intraoperative or postoperative intraaortic balloon pump, lower rates of postoperative atrial fibrillation, and a shorter length of stay.

Perioperative Increases in Serum Creatinine Are Predictive of Increased 90-Day Mortality After Coronary Artery Bypass Graft Surgery

Background— Impaired renal function after coronary artery bypass graft (CABG) surgery is a key risk factor for in-hospital mortality. However, perioperative increases in serum creatinine and the association with mortality has not been well-studied. We assessed the hypothesis that perioperative increases in creatinine are associated with increased 90-day mortality. Methods and Results— We studied 1391 patients in northern New England undergoing CABG in 2001 and evaluated preoperative and postoperative creatinine. Patients with preoperative dialysis were excluded. Data were linked to the National Death Index to assess 90-day survival. Kaplan-Meier and log-rank techniques were used. Patients were stratified by percent increase in creatinine from baseline: <25%, 25% to 49%, 50% to 99%, ≥100%. We assessed 90-day survival and calculated adjusted hazard ratios (HR) and 95% confidence intervals (95% CI) for creatinine groups, adjusting for age and sex. Patients with the largest creatinine increases (50% to 99% or ≥100%) had significantly higher 90-day mortality compared with patients with a smaller increase (<50%; P<0.001). Adjusted HR and 95% CI confirmed patients in the higher 2 groups had an increased risk of mortality compared with the <25% (referent); however, the 25% to 49% group was not different from the referent: 1.80 (95% CI: 0.73 to 4.44), 6.57 (95% CI, 3.03 to 14.27), and 22.10 (95% CI, 11.25 to 43.39). Conclusions— Patients with large creatinine increases (≥50%) after CABG surgery have a higher 90-day mortality compared with patients with small increases. Efforts to identify patients with impaired renal function and to preserve renal function before cardiac surgery may yield benefits for patients in the future.

Effect of Diabetes and Associated Conditions on Long-Term Survival After Coronary Artery Bypass Graft Surgery

Background—The effects of diabetes on short-term results of coronary artery bypass graft (CABG) surgery are known, but less is known about the long-term effects of diabetes and diabetic-related sequelae for patients undergoing this surgery. We studied the 10-year survival of nondiabetic and diabetic patients undergoing CABG surgery. Methods and Results—A prospective regional cohort study was conducted of 36 641 consecutive isolated CABG patients in northern New England from 1992 through 2001. Patient records were linked to the National Death Index to assess mortality. There were 154 140 person-years of follow-up and 5779 deaths. Kaplan–Meier techniques were used. Survival was stratified into three categories: no diabetes, diabetes without peripheral vascular disease and renal failure, and diabetes with peripheral vascular disease and/or renal failure. The overall annual incidence rate of death was 3.7 deaths per 100 person-years. Annual incidence rates for nondiabetic subjects and diabetic subjects were similar: 3.1 deaths per 100 person-years and 4.4 deaths per 100 person-years, respectively. The annual incidence rate for diabetic subjects with renal failure, peripheral vascular disease, or both was 9.4 deaths per 100 person-years. The log-rank test showed that the survival curves were significantly different (P<0.001). Conclusion—Patients that have diabetes without the sequelae of renal failure and/or peripheral vascular disease have long-term survival similar to but slightly less than patients without diabetes who undergo CABG surgery. Survival of CABG surgery patients with diabetes is greatly affected by associated comorbidities of peripheral vascular disease and renal failure. This knowledge may help guide the patient as well as the cardiologist and cardiac surgeon in making appropriate decisions in these critically ill patients.

Development and Validation of a Prediction Model for Strokes After Coronary Artery Bypass Grafting

BACKGROUND A prospective study of patients undergoing coronary artery bypass graft surgery (CABG) was conducted to identify patient and disease factors related to the development of a perioperative stroke. A preoperative risk prediction model was developed and validated based on regionally collected data. METHODS We performed a regional observational study of 33,062 consecutive patients undergoing isolated CABG surgery in northern New England between 1992 and 2001. The regional stroke rate was 1.61% (532 strokes). We developed a preoperative stroke risk prediction model using logistic regression analysis, and validated the model using bootstrap resampling techniques. We assessed the models fit, discrimination, and stability. RESULTS The final regression model included the following variables: age, gender, presence of diabetes, presence of vascular disease, renal failure or creatinine greater than or equal to 2 mg/dL, ejection fraction less than 40%, and urgent or emergency. The model significantly predicted (chi(2) [14 d.f.] = 258.72, p < 0.0001) the occurrence of stroke. The correlation between the observed and expected strokes was 0.99. The risk prediction model discriminated well, with an area under the relative operating characteristic curve of 0.70 (95% CI, 0.67 to 0.72). In addition, the model had acceptable internal validity and stability as seen by bootstrap techniques. CONCLUSIONS We developed a robust risk prediction model for stroke using seven readily obtainable preoperative variables. The risk prediction model performs well, and enables a clinician to estimate rapidly and accurately a CABG patients preoperative risk of stroke.

Results of a regional study of modes of death associated with coronary artery bypass grafting

BACKGROUND It is well known that surgeon-specific in-hospital mortality rates for coronary artery bypass grafting vary, but this aggregate measure does not suggest specific opportunities for improvement. METHODS We performed a regional prospective study of 8,641 consecutive patients undergoing isolated coronary artery bypass grafting by all of the 23 cardiothoracic surgeons practicing in northern New England during the study period. Mode of death was assigned by an end points committee using predetermined definitions. Surgeons were ranked according to risk-adjusted mortality rates and grouped in terciles, and cause-specific mortality rates were determined. RESULTS The mortality rate was 3.3% in the lowest surgeon mortality tercile and 5.8% in the highest tercile. Fatal heart failure accounted for 80.0% of the difference in aggregate mortality rates, ranging from 1.9% in lowest surgeon mortality tercile to 4.0% in the highest tercile (p < 0.001). Rates of other causes did not differ significantly across surgeon mortality terciles. Differences in rates of fatal heart failure could not be explained by differences in preoperative left ventricular dysfunction or other patient characteristics. CONCLUSIONS Most of the difference in observed mortality rates across surgeons is attributable to differences in rates of heart failure.