Quality improvement program decreases mortality after cardiac surgery

ObjectiveThis study investigated the effects of a quality improvement program and goal-oriented, multidisciplinary protocols on mortality after cardiac surgery.MethodsPatients were divided into two groups: those undergoing surgery (coronary artery bypass grafting, isolated valve surgery, or coronary artery bypass grafting and valve surgery) after establishment of the multidisciplinary quality improvement program (January 2005–December 2006, n = 922) and those undergoing surgery before institution of the program (January 2002–December 2003, n = 1289). Logistic regression and propensity score analysis were used to adjust for imbalances in patients' preoperative characteristics.ResultsOperative mortality was lower in the quality improvement group (2.6% vs 5.0%, P < .01). Unadjusted odds ratio was 0.5 (95% confidence interval 0.3–0.8, P < .01); propensity score–adjusted odds ratio was 0.6 (95% confidence interval 0.4–0.99, P = .04). In multivariable analysis, diabetes (P < .01), chronic renal insufficiency (P = .05), previous cardiovascular operation (P = .04), congestive heart failure (P < .01), unstable angina (P < .01), age older than 75 years (P < .01), prolonged pump time (P < .01), and prolonged operation (P = .05) emerged as independent predictors of higher mortality after cardiac surgery, whereas quality improvement program (P < .01) and male sex (P = .03) were associated with lower mortality. Mortality decline was less pronounced in patients with than without diabetes (P = .04).ConclusionApplication of goal-directed, multidisciplinary protocols and a quality improvement program were associated with lower mortality after cardiac surgery. This decline was less prominent in patients with diabetes, and focused quality improvement protocols may be required for this subset of patients

Coagulation, fibrinolysis, and cell activation in patients and shed mediastinal blood during coronary artery bypass grafting with a new heparin-coated surface

AbstractObjectives: Heparin coating of the cardiopulmonary bypass circuit is shown to improve the biocompatibility of the surface. We have studied a new heparin surface, the Corline Heparin Surface, applied to a complete set of an extracorporeal device used during coronary artery bypass grafting in terms of activation of inflammation, coagulation, and fibrinolysis in patients and in shed mediastinal blood. Methods: Sixty patients scheduled for coronary artery bypass grafting were randomized to one of 3 groups with heparin-coated devices receiving either a standard, high, or low dose of systemic heparin or to an uncoated but otherwise identical circuit receiving a standard dose of systemic heparin. Samples were drawn before, during, and after the operation from the pericardial cavity and in shed mediastinal blood. No autotransfusion of shed mediastinal blood was performed. Results: The Corline Heparin Surface significantly reduced the activation of coagulation, fibrinolysis, platelets, and inflammation compared with that seen with the uncoated surface in combination with a standard dose of systemic heparin during cardiac surgery with cardiopulmonary bypass. Both a decrease and an increase of systemic heparin in combination with the coated heparin surface resulted in higher activation of these processes. A significantly higher expression of all studied parameters was found in the shed mediastinal blood compared with in systemic blood at the same time. Conclusions: The Corline Heparin Surface used in cardiopulmonary bypass proved to be more biocompatible than an uncoated surface when using a standard systemic heparin dose. The low dose of systemic heparin might not be sufficient to maintain the antithrombotic activity, and the high dose resulted in direct cell activation rather than a further anti-inflammatory and anticoagulatory effect.J Thorac Cardiovasc Surg 2002;124:321-3

Adverse events during reoperative cardiac surgery: Frequency, characterization, and rescue

ObjectivesTo (1) determine frequency of occurrence and risk factors for intraoperative adverse events (IAE) during reoperative cardiac surgery, (2) characterize them with respect to structure injured, timing, and use of preventive strategies, and (3) identify the impact on outcome in terms of successful and unsuccessful rescue and cost.MethodsOperative notes of 1847 patients undergoing reoperative cardiac surgery were reviewed to identify and characterize documented intraoperative adverse events. Logistic regression modeling was used to identify risk factors for intraoperative adverse events and outcomes. Expected versus observed poor outcomes (stroke, myocardial infarction, death) was used to measure rescue.ResultsAmong 127 patients, 145 (7%) intraoperative adverse events occurred. These included injuries to bypass grafts (n = 47), heart (n = 38), and great vessels (n = 28) and ischemia without graft injury (n = 22). Most occurred on opening (n = 34, 23%) and during prebypass dissection (n = 57, 39%). Risk incremented as reoperations increased. Seventy-seven patients experienced 1 or more lapses in preventive strategies. Patients with intraoperative adverse events had a greater number of poor outcomes (n = 24 [19%] vs n = 107 [6.2%]; P < .0001) and incurred higher direct technical intraoperative and postoperative costs (ratio 1.3). Twelve patients with intraoperative adverse events were predicted to have poor outcomes versus 24 who did (P < .0001), indicating 12 “failures to rescue.”ConclusionsAdverse events still occur regularly during cardiac reoperation, are related to complexity of the procedure, and occur particularly during dissection and often when preventive strategies have not been used. Compensatory rescue measures are not always successful. Adverse events lead to poor patient outcome and higher cost

Revascularization in multivessel disease: Comparison between two-year outcomes of coronary bypass surgery and stenting

AbstractObjective: The recent appreciation that stenting has improved the short- and long-term outcomes of patients treated with coronary angioplasty has made it imperative to reconsider the comparison between surgery and percutaneous interventions in patients with multivessel disease. Methods: One thousand two hundred five patients were randomly assigned to undergo bypass surgery or angioplasty with stent implantation when there was consensus between the cardiac surgeon and interventional cardiologist as to equivalent treatability. The primary clinical end point was freedom from major adverse cardiac and cerebrovascular events at 1 year. Major adverse cardiac and cerebrovascular events at 2 years constituted a secondary end point. Results: At 2 years, 89.6% of the surgical group and 89.2% of the stent group were free from death, stroke, and myocardial infarction (log-rank test P =.65). Among patients who survived without stroke or myocardial infarction, 19.7% in the stent group underwent a second revascularization, as compared with 4.8% in the surgical group (P <.001). At 2 years, 84.8% of the surgical group and 69.5% of the stent group were event-free survivors (log-rank test P <.001), and 87.2% in the surgical cohort and 79.6 % in the stent group were angina-free survivors (P =.001). In the diabetes subgroup, 82.3% of the surgical group and 56.3% of the stent group were free from any events after 2 years (log-rank test P <.001). Conclusion: The difference in outcome between surgery and stenting observed at 1 year in patients with multivessel disease remained essentially unchanged at 2 years. Stenting was associated with a greater need for repeat revascularization. In view of the relatively greater difference in outcome in patients with diabetes, surgery clearly seems to be the preferable form of treatment for these patients.J Thorac Cardiovasc Surg 2003;125:809-2

Effect of perioperative complications on excess mortality among women after coronary artery bypass: The israeli coronary artery bypass graft study (ISCAB)

AbstractBackground: Widely observed excess mortality among women after coronary artery bypass grafting is still largely unexplained, although case-mix factors have been identified. We evaluated the contribution of perioperative complications to the risk of 180-day mortality among women while adjusting for case-mix factors. Methods: This is part of a prospective, 1-year nationwide Israeli coronary artery bypass graft study of 1029 female and 3806 male patients. Deaths within 180 days were independently ascertained. Case-mix risk strata were obtained from a pooled Cox survival model (including all subjects and study variables) by using the adjusted coefficients corresponding to the case-mix factors within the model. Sex-specific mortality associated with perioperative complications was evaluated within the strata. In addition, sex-specific Cox models were constructed. Results: Higher mortality among women compared with that among men was significant within the pooled model (hazard ratio, 1.4; P =.038) and was evident early in the postoperative period. Women tended to cluster in the highest risk quartile compared with men (39.8% vs 20.9%, P <.001). However, although the incidence of perioperative complications was similar for the 2 sexes, the associated mortality for a given perioperative complication was higher among women. Sex-specific Cox models confirmed the above findings. For example, the hazard ratio for women with low postoperative hemoglobin was 6.9, whereas for men, the hazard ratio was 3.9. Conclusions: The role of perioperative factors in the excess mortality among women after coronary artery bypass grafting shifts the focus of attention from the selection of women for the operation to the in-hospital experience. Improving the outcome for women will entail efforts to prevent complications in the perioperative period.J Thorac Cardiovasc Surg 2002;123:517-2

The impact of patient–prosthesis mismatch on late outcomes after mitral valve replacement

ObjectivesThe incidence of patient–prosthesis mismatch after mitral valve replacement and its effect on late outcomes have remained unclear. This study was conducted to determine the impact of patient–prosthesis mismatch on recurrent congestive heart failure, postoperative pulmonary hypertension, and late survival after mitral valve replacement.MethodsBetween 1985 and 2005, 884 patients, with a mean age 63 ± 12 years, underwent mitral valve replacement (657 mechanical, 227 bioprosthesis) with contemporary prostheses. Mean clinical and echocardiographic follow-up was 5.1 ± 4.1 years (4344 patient-years). Patient–prosthesis mismatch was defined as an indexed effective orifice area of 1.25 cm2/m2 or less. Parametric and nonparametric analyses were used to determine predictors of outcomes.ResultsThe incidence of patient–prosthesis mismatch was 32%. Predictors of recurrent congestive heart failure included low indexed effective orifice area, low ejection fraction, elevated postoperative mean mitral gradient, and use of a bioprosthesis (P ≤ .05). Postoperative pulmonary hypertension was associated with small mitral size, elevated mean mitral gradient, low ejection fraction, and atrial fibrillation (P ≤ .05); indexed effective orifice area did not predict postoperative pulmonary hypertension (P = .89). Poor late survival was predicted by low indexed effective orifice area (≤1.25 cm2/m2), New York Heart Association class 3 or 4, elevated right ventricular pressure, stroke, older age, coronary artery disease, and bioprosthesis use (P ≤ .05). Survival for patients with patient–prosthesis mismatch versus those without patient–prosthesis mismatch at 1, 3, 5, and 10 years was 91% versus 95%, 85% versus 90%, 78% versus 86%, and 65% versus 75%, respectively (P = .05).ConclusionsPatient–prosthesis mismatch after mitral valve replacement is not uncommon; it is associated with recurrence of congestive heart failure and postoperative pulmonary hypertension and independently affected late survival. This study emphasizes the importance of implanting a sufficiently large prosthesis in adult patients undergoing mitral valve replacement

Endovascular stent grafting versus open surgical repair of descending thoracic aortic aneurysms in low-risk patients: A multicenter comparative trial

ObjectiveResults are presented from the first completed multicenter trial directed at gaining approval from the US Food and Drug Administration of endovascular versus open surgical repair of descending thoracic aortic aneurysms.MethodsBetween September 1999 and May 2001, 140 patients with descending thoracic aneurysms were enrolled at 17 sites and evaluated for a Gore TAG Thoracic Endograft. An open surgical control cohort of 94 patients was identified by enrolling historical and concurrent subjects. Patients were assessed before treatment, at treatment, and at hospital discharge and returned for follow-up visits at 1 month, 6 months, and annually thereafter.ResultsOne hundred thirty-seven of 140 patients had successful implantation of the endograft. Perioperative mortality in the endograft versus open surgical control cohort was 2.1% (n = 3) versus 11.7% (n = 11, P < .001). Thirty-day analysis revealed a statistically significant lower incidence of the following complications in the endovascular cohort versus the surgical cohort: spinal cord ischemia (3% vs 14%), respiratory failure (4% vs 20%), and renal insufficiency (1% vs 13%). The endovascular group had a higher incidence of peripheral vascular complications (14% vs 4%). The mean lengths of intensive care unit stay (2.6 ± 14.6 vs 5.2 ± 7.2 days) and hospital stay (7.4 ± 17.7 vs 14.4 ± 12.8 days) were significantly shorter in the endovascular cohort. At 1 and 2 years’ follow-up, the incidence of endoleaks was 6% and 9%, respectively. Through 2 years of follow-up, there were 3 reinterventions in the endograft cohort and none in the open surgical control cohort. Kaplan–Meier analysis revealed no difference in overall mortality at 2 years.ConclusionsIn this multicenter study early outcomes with descending aortic endovascular stent grafting were very encouraging when compared with those of a well-matched surgical cohort. However, at 2 years’ follow-up, there is an incidence of endoleaks and reinterventions associated with endovascular versus open surgical repair. Continued vigilant surveillance of patients treated with an endograft is important

Does right thoracotomy increase the risk of mitral valve reoperation?

ObjectiveThe study objective was to determine whether a right thoracotomy approach increases the risk of mitral valve reoperation.MethodsBetween January of 1993 and January of 2004, 2469 patients with mitral valve disease underwent 2570 reoperations (1508 replacements, 1062 repairs). The approach was median sternotomy in 2444 patients, right thoracotomy in 80 patients, and other in 46 patients. Multivariable logistic regression was used to identify factors associated with median sternotomy versus right thoracotomy, mitral valve repair versus replacement, hospital death, and stroke. Factors favoring median sternotomy (P < .03) included coronary artery bypass grafting (30% vs 2%), aortic valve replacement (39% vs 2%), tricuspid valve repair (27% vs 13%), fewer previous cardiac operations, more recent reoperation, and no prior left internal thoracic artery graft. These factors were used to construct a propensity score for risk-adjusting outcomes.ResultsHospital mortality was 6.7% (163/2444) for the median sternotomy approach and 6.3% (5/80) for the thoracotomy approach (P = .9). Risk factors (P < .04) included earlier surgery date, higher New York Heart Association class, emergency operation, multiple reoperations, and mitral valve replacement. Stroke occurred in 66 patients (2.7%) who underwent a median sternotomy and in 6 patients (7.5%) who underwent a thoracotomy (P = .006). Mitral valve replacement (vs repair) was more common in those receiving a thoracotomy (P < .04).ConclusionsCompared with median sternotomy, right thoracotomy is associated with a higher occurrence of stroke and less frequent mitral valve repair. Specific strategies for conducting the operation should be used to reduce the risk of stroke when right thoracotomy is used for mitral valve reoperation. In most instances, repeat median sternotomy, with its better exposure and greater latitude for concomitant procedures, is preferred

Regional cerebral saturation monitoring with near-infrared spectroscopy during selective antegrade cerebral perfusion: Diagnostic performance and relationship to postoperative stroke

ObjectiveTo investigate whether regional cerebral tissue oxygen saturation monitoring during hypothermic selective antegrade cerebral perfusion in surgery involving the aortic arch can predict neurologic sequelae and to evaluate the diagnostic performance of near-infrared spectroscopy monitoring in this setting.MethodsData from 46 consecutive patients were analyzed. Selective antegrade cerebral perfusion was established by perfusion of the right subclavian artery (with or without left carotid artery perfusion) or by separate concomitant perfusion of the innominate and the left carotid arteries. The bilateral regional cerebral tissue oxygen saturation index was monitored by using near-infrared spectroscopy equipment (INVOS 4100). Stroke was the primary clinical end point, along with the indices of diagnostic performance.ResultsSix patients died in the hospital, and 6 patients (13%) experienced a perioperative stroke. In patients with stroke, regional cerebral tissue oxygen saturation values were significantly lower during selective antegrade cerebral perfusion, and regional cerebral tissue oxygen saturation tended to be lower in the affected hemisphere. In receiver operating characteristic curve analysis, the area under the curve for relative regional cerebral tissue oxygen saturation values ranged from 0.72 to 0.87. During selective antegrade cerebral perfusion, regional cerebral tissue oxygen saturation between 76% and 86% of baseline had a sensitivity up to 83% and a specificity up to 94% in identifying individuals with stroke. The associated odds ratio for stroke was 5.6 (95% confidence interval, 0.5-144) to 21 (95% confidence interval, 1.8-566).ConclusionsMonitoring of regional cerebral tissue oxygen saturation by using near-infrared spectroscopy during selective antegrade cerebral perfusion allows detection of clinically important cerebral desaturation. It can help predict perioperative neurologic sequelae. Its performance as a diagnostic instrument is satisfying and supports its use as a noninvasive trend monitor of cerebral saturation

Vascular endothelial growth factor transgene expression in cell-transplanted hearts

AbstractObjectiveWe evaluated the effect of transplanted cell type, time, and region of the heart on transgene expression to determine the potential of combined gene and cell delivery for myocardial repair.MethodsLewis rats underwent myocardial cryoinjury 3 weeks before transplantation with heart cells (a mixed culture of cardiomyocytes, smooth muscle cells, endothelial cells and fibroblasts, n = 13), vascular endothelial growth factor–transfected heart cells (n = 13), skeletal myoblasts (n = 13), vascular endothelial growth factor–transfected skeletal myoblasts (n = 13), or medium (control, n = 12). Vascular endothelial growth factor expression in the scar, border zone, and normal myocardium was evaluated at 3 days and at 1, 2, and 4 weeks by means of quantitative polymerase chain reaction. Transplanted cells and vascular endothelial growth factor protein were identified immunohistologically on myocardial sections.ResultsVascular endothelial growth factor levels were very low in control scars but increased transiently after medium injection. Transplantation with heart cells and skeletal myoblasts significantly increased vascular endothelial growth factor expression in the scar and border zone. Transplantation of vascular endothelial growth factor–transfected heart cells and vascular endothelial growth factor–transfected skeletal myoblasts further augmented vascular endothelial growth factor expression, resulting in 4- to 5-fold greater expression of vascular endothelial growth factor in the scar at 1 week. Peak vascular endothelial growth factor expression was greater and earlier in vascular endothelial growth factor–transfected heart cells than in vascular endothelial growth factor–transfected skeletal myoblasts. Vascular endothelial growth factor was primarily expressed by the transplanted cells. Some of the transplanted heart cells and vascular endothelial growth factor–transfected heart cells were identified in the endothelial layer of blood vessels in the scar.ConclusionsTransplantation of heart cells and skeletal myoblasts induces vascular endothelial growth factor expression in myocardial scars and is greatly augmented by prior transfection with a vascular endothelial growth factor transgene. Vascular endothelial growth factor expression is limited to the scar and border zone for 4 weeks. Both heart cells and skeletal myoblasts may be excellent delivery vehicles for cell-based myocardial gene therapy