Richard J. Novick

Monitoring brain oxygen saturation during coronary bypass surgery: a randomized, prospective study.

BACKGROUND:Cerebral deoxygenation is associated with various adverse systemic outcomes. We hypothesized, by using the brain as an index organ, that interventions to improve cerebral oxygenation would have systemic benefits in cardiac surgical patients. METHODS:Two-hundred coronary artery bypass patients were randomized to either intraoperative cerebral regional oxygen saturation (rSO2) monitoring with active display and treatment intervention protocol (intervention, n = 100), or underwent blinded rSO2 monitoring (control, n = 100). Predefined clinical outcomes were assessed by a blinded observer. RESULTS:Significantly more patients in the control group demonstrated prolonged cerebral desaturation (P = 0.014) and longer duration in the intensive care unit (P = 0.029) versus intervention patients. There was no difference in overall incidence of adverse complications, but significantly more control patients had major organ morbidity or mortality (death, ventilation >48 h, stroke, myocardial infarction, return for re-exploration) versus intervention group patients (P = 0.048). Patients experiencing major organ morbidity or mortality had lower baseline and mean rSO2, more cerebral desaturations and longer lengths of stay in the intensive care unit and postoperative hospitalization, than patients without such complications. There was a significant (r2 = 0.29) inverse correlation between intraoperative rSO2 and duration of postoperative hospitalization in patients requiring ≥10 days postoperative length of stay. CONCLUSION:Monitoring cerebral rSO2 in coronary artery bypass patients avoids profound cerebral desaturation and is associated with significantly fewer incidences of major organ dysfunction.

The registry of the international society for heart and lung transplantation: eighteenth official report—2001

In this last report of the Registry’s current administration, it is appropriate to review the changes and growth of the Registry during our 7-year stewardship. The total number of thoracic transplant recipients listed in the Registry has grown from 35,972 to more than 73,000 (see Table I). In addition to the increase in sheer volume of data, the breadth and sophistication of the analyses increased, from descriptive and univariate survival analyses to complex multivariate, risk-stratified data that investigate mortality as well as morbidity end-points. In 1993, the number of slides showing thoracic transplant data offered as a service to the members of the International Society for Heart and Lung Transplantation (ISHLT) was in the mid-30s. This year’s slide set offered free as a PowerPointTM file on the ISHLT website will contain 65 data slides. The health of the Registry will continue with a smooth transition to the new directorship.

Effect of diagnosis on survival benefit of lung transplantation for end-stage lung disease

BACKGROUND Although certain forms of end-stage lung disease are debilitating, whether the associated mortality rate exceeds that of transplantation is unclear. We undertook analysis to clarify the survival benefit of lung transplantation for various types of end-stage lung disease. METHODS We analysed data for all patients listed for transplantation in the USA for emphysema, cystic fibrosis, or interstitial pulmonary fibrosis in the years 1992-94. The numbers of patients entered on the waiting list, post-transplantation, died waiting, and currently waiting were: emphysema group 1274, 843, 143, and 165; cystic fibrosis group 664, 318, 193, and 59; interstitial pulmonary fibrosis group 481, 230, 160, and 48. A time-dependent non-proportional hazard analysis was used to assess the risk of mortality after transplantation relative to that for patients on the waiting list. FINDINGS The clearest survival benefit from lung transplantation occurred in the cystic fibrosis group. The relative risks of transplantation compared with waiting were 0.87, 0.61, and 0.61 at 1 month, 6 months, and 1 year (p = 0.008), respectively. For interstitial pulmonary fibrosis, the corresponding relative risks were 2.09, 0.71, and 0.67 (p = 0.09). No survival benefit was apparent in the emphysema group. The risks of transplantation relative to waiting were 2.76, 1.12, and 1.10 at 1 month, 6 months, and 1 year, respectively, and the relative risk did not decrease to below 1.0 during 2 years of follow-up. INTERPRETATION These findings suggest that lung transplantation does not confer a survival benefit in patients with end-stage emphysema by 2 years of follow-up. Other benefits not accounted for in this analysis such as improved quality of life, however, may justify lung transplantation for these patients.

The Registry of the International Society for Heart and Lung Transplantation: Seventeenth Official Report—2000

The Registry of the International Society for Heart and Lung Transplantation has grown substantially during the past 5 years, from a little more than 43,000 registered procedures at the end of 1994 to almost 70,000 registered procedures by the end of 1999 (see Table I). The substantial increase during this 5-year period occurred despite overall annual transplant numbers that were flat or that declined. We attribute this increase to obtaining more complete data from national and multinational registries, from capturing new centers that did not previously report, and finally, from direct Internetbased data reporting by individual centers. During this same 5-year period, excluding the annual reports, the Registry has peer reviewed 23 publications, reviews, and book chapters. J Heart Lung Transplant 2000;19:909.

Does Off-pump Coronary Artery Bypass Reduce Mortality, Morbidity, and Resource Utilization When Compared with Conventional Coronary Artery Bypass? A Meta-analysis of Randomized Trials

The authors undertook a meta-analysis of 37 randomized trials (3369 patients) of off-pump coronary artery bypass surgery versus conventional coronary artery bypass surgery. No significant differences were found for 30-day mortality (odds ratio [OR], 1.02; 95% confidence interval [CI], 0.58–1.80), myocardial infarction (OR, 0.77; 95%CI, 0.48–1.26), stroke (OR, 0.68; 95%CI, 0.33–1.40), renal dysfunction, intraaortic balloon pump, wound infection, rethoracotomy, or reintervention. However, off-pump coronary artery bypass surgery significantly decreased atrial fibrillation (OR, 0.58; 95%CI, 0.44–0.77), transfusion (OR, 0.43; 95%CI, 0.29–0.65), inotrope requirements (OR, 0.48; 95%CI, 0.32–0.73), respiratory infections (OR, 0.41; 95%CI, 0.23–0.74), ventilation time (weighted mean difference, −3.4 h; 95%CI, −5.1 to −1.7 h), intensive care unit stay (weighted mean difference, −0.3 days; 95%CI −0.6 to −0.1 days), and hospital stay (weighted mean difference, −1.0 days; 95%CI −1.5 to −0.5 days). Patency and neurocognitive function results were inconclusive. In-hospital and 1-yr direct costs were generally higher for conventional coronary artery bypass surgery versus off-pump coronary artery bypass surgery. Therefore, this meta-analysis demonstrates that mortality, stroke, myocardial infarction, and renal failure were not reduced in off-pump coronary artery bypass surgery surgery; however, selected short-term and mid-term clinical and resource outcomes were improved compared with conventional coronary artery bypass surgery.

Off-Pump or On-Pump Coronary-Artery Bypass Grafting at 30 Days

BACKGROUND The relative benefits and risks of performing coronary-artery bypass grafting (CABG) with a beating-heart technique (off-pump CABG), as compared with cardiopulmonary bypass (on-pump CABG), are not clearly established. METHODS At 79 centers in 19 countries, we randomly assigned 4752 patients in whom CABG was planned to undergo the procedure off-pump or on-pump. The first coprimary outcome was a composite of death, nonfatal stroke, nonfatal myocardial infarction, or new renal failure requiring dialysis at 30 days after randomization. RESULTS There was no significant difference in the rate of the primary composite outcome between off-pump and on-pump CABG (9.8% vs. 10.3%; hazard ratio for the off-pump group, 0.95; 95% confidence interval [CI], 0.79 to 1.14; P=0.59) or in any of its individual components. The use of off-pump CABG, as compared with on-pump CABG, significantly reduced the rates of blood-product transfusion (50.7% vs. 63.3%; relative risk, 0.80; 95% CI, 0.75 to 0.85; P<0.001), reoperation for perioperative bleeding (1.4% vs. 2.4%; relative risk, 0.61; 95% CI, 0.40 to 0.93; P=0.02), acute kidney injury (28.0% vs. 32.1%; relative risk, 0.87; 95% CI, 0.80 to 0.96; P=0.01), and respiratory complications (5.9% vs. 7.5%; relative risk, 0.79; 95% CI, 0.63 to 0.98; P=0.03) but increased the rate of early repeat revascularizations (0.7% vs. 0.2%; hazard ratio, 4.01; 95% CI, 1.34 to 12.0; P=0.01). CONCLUSIONS There was no significant difference between off-pump and on-pump CABG with respect to the 30-day rate of death, myocardial infarction, stroke, or renal failure requiring dialysis. The use of off-pump CABG resulted in reduced rates of transfusion, reoperation for perioperative bleeding, respiratory complications, and acute kidney injury but also resulted in an increased risk of early revascularization. (Funded by the Canadian Institutes of Health Research; CORONARY ClinicalTrials.gov number, NCT00463294.).

Effects of Off-Pump and On-Pump Coronary-Artery Bypass Grafting at 1 Year

BACKGROUND Previously, we reported that there was no significant difference at 30 days in the rate of a primary composite outcome of death, myocardial infarction, stroke, or new renal failure requiring dialysis between patients who underwent coronary-artery bypass grafting (CABG) performed with a beating-heart technique (off-pump) and those who underwent CABG performed with cardiopulmonary bypass (on-pump). We now report results on quality of life and cognitive function and on clinical outcomes at 1 year. METHODS We enrolled 4752 patients with coronary artery disease who were scheduled to undergo CABG and randomly assigned them to undergo the procedure off-pump or on-pump. Patients were enrolled at 79 centers in 19 countries. We assessed quality of life and cognitive function at discharge, at 30 days, and at 1 year and clinical outcomes at 1 year. RESULTS At 1 year, there was no significant difference in the rate of the primary composite outcome between off-pump and on-pump CABG (12.1% and 13.3%, respectively; hazard ratio with off-pump CABG, 0.91; 95% confidence interval [CI], 0.77 to 1.07; P=0.24). The rate of the primary outcome was also similar in the two groups in the period between 31 days and 1 year (hazard ratio, 0.79; 95% CI, 0.55 to 1.13; P=0.19). The rate of repeat coronary revascularization at 1 year was 1.4% in the off-pump group and 0.8% in the on-pump group (hazard ratio, 1.66; 95% CI, 0.95 to 2.89; P=0.07). There were no significant differences between the two groups at 1 year in measures of quality of life or neurocognitive function. CONCLUSIONS At 1 year after CABG, there was no significant difference between off-pump and on-pump CABG with respect to the primary composite outcome, the rate of repeat coronary revascularization, quality of life, or neurocognitive function. (Funded by the Canadian Institutes of Health Research; CORONARY ClinicalTrials.gov number, NCT00463294.).

The Registry of the International Society for Heart and Lung Transplantation: Fifteenth Official Report—1998

Over the past 12 months, The Registry of the International Society for Heart and Lung Transplantation added 20 new transplantation programs and a total of 7073 additional thoracic organ recipients. All of the national and multinational registries are now fully integrated into our registry, and electronic data submission via the Internet will be instituted by mid 1998 for those centers not participating in larger registries. For the first time, the entire data set was used to calculate multivariate risks rather than the U.S. data set alone, and we have continued to extend the time frame for both univariate and multivariate analyses. For this report, risk factors for 5-year outcome and morbidity at 3 years are presented.

Off-pump surgery decreases postoperative complications and resource utilization in the elderly

BACKGROUND Bypass surgery in the elderly (age >70 years) has increased mortality and morbidity, which may be a consequence of cardiopulmonary bypass. We compare the outcomes of a cohort of elderly off-pump coronary artery bypass (OPCAB) patients with elderly conventional coronary artery bypass grafting (CABG) patients. METHODS Chart and provincial cardiac care registry data were reviewed for 30 consecutive elderly OPCAB patients (age 74.7 +/- 4.2 years) and 60 consecutive CABG patients (age 74.9 +/- 4.1 years, p = 0.82) with similar risk factor profiles: Parsonnet score 17.2 +/- 8.1 (OPCAB) versus 15.6 +/- 6.5 (CABG), p = 0.31; and Ontario provincial acuity index 4.5 +/- 1.9 (OPCAB) versus 4.3 +/- 2.0 (CABG), p = 0.65. RESULTS Mean hospital stay was 6.3 +/- 1.8 days for OPCAB patients and 7.7 +/- 3.9 days for CABG patients (p < 0.05). Average intensive care unit stay was 24.0 +/- 10.9 h for OPCAB patients versus 36.6 +/- 33.5 h for CABG patients (p < 0.05). Atrial fibrillation occurred in 10.0% of OPCAB patients and 28.3% of CABG patients (p < 0.05). Low output syndrome was observed in 10% of OPCAB patients and 31.7% of CABG patients (p < 0.05). Cost was reduced by

Aprotinin significantly decreases bleeding and transfusion requirements in patients receiving aspirin and undergoing cardiac operations

1,082 (Canadian) per patient in the OPCAB group. Postoperative OPCAB graft analysis showed 100% patency. CONCLUSIONS OPCAB is safe in the geriatric population and significantly reduces postoperative morbidity and cost.