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Background: Clinical trial data studies suggest superiority of prasugrel over clopidogrel in patients with diabetes. However, the use, safety and efficacy profile of prasugrel in unselected diabetic patients presenting with acute coronary syndromes (ACS) remain unclear., Methods: PROMETHEUS was a prospective multicenter observational study of 19,919 ACS PCI patients enrolled between 2010 and 2013. The primary endpoint was 90-day major adverse cardiovascular events (MACE), comprising all-cause death, myocardial infarction, stroke or unplanned revascularization. The safety endpoint was bleeding requiring hospitalization., Results: We identified 7580 (38%) subjects with and 12,329 (62%) without diabetes. Diabetic patients were older and had significantly higher rates of cardiovascular risk factors. However, they were less likely to receive prasugrel (18.2% vs. 21.7%). Use of prasugrel did not increase with the severity of clinical presentation in diabetics, whereas, among non-diabetics, prescription of prasugrel was higher in NSTEMI and STEMI compared to unstable angina. The 90-day and 1-year adjusted risk of MACE was greater in diabetics (at 1 year: 22.7% vs. 16.5%; HR 1.22 [1.14-1.33], p < 0.001). At 1 year, the risk of bleeding was also higher in diabetics (4.9% vs. 4.1%, HR 1.19 [1.01-1.39], p = 0.035). After multivariable adjustment, use of prasugrel was associated with a lower risk of death in diabetic patients both at 90 days and 1 year., Conclusions: Use of prasugrel in diabetic patients with PCI-treated ACS was lower than in non-diabetics despite their high-risk profile and the severity of their clinical presentation. In diabetics, prasugrel was associated with a lower adjusted risk of 90-day death compared with clopidogrel., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Background: Potent P2Y 12 inhibitors might offer enhanced benefit against thrombotic events in complex percutaneous coronary intervention (PCI). We examined prasugrel use and outcomes according to PCI complexity, as well as analyzing treatment effects according to thienopyridine type., Methods: PROMETHEUS was a multicentre observational study that compared clopidogrel vs prasugrel in acute coronary syndrome patients who underwent PCI (n = 19,914). Complex PCI was defined as PCI of the left main, bifurcation lesion, moderate-severely calcified lesion, or total stent length ≥ 30 mm. Major adverse cardiac events (MACE) were a composite of death, myocardial infarction, stroke, or unplanned revascularization. Outcomes were adjusted using multivariable Cox regression for effect of PCI complexity and propensity-stratified analysis for effect of thienopyridine type., Results: The study cohort included 48.9% (n = 9735) complex and 51.1% (n = 10,179) noncomplex patients. Second generation drug-eluting stents were used in 70.1% complex and 66.2% noncomplex PCI patients (P < 0.0001). Complex PCI was associated with greater adjusted risk of 1-year MACE (hazard ratio [HR], 1.29; 95% confidence interval [CI], 1.20-1.39; P < 0.001). Prasugrel was prescribed in 20.7% of complex and 20.1% of noncomplex PCI patients (P = 0.30). Compared with clopidogrel, prasugrel significantly decreased adjusted risk for 1-year MACE in complex PCI (HR, 0.79; 95% CI, 0.68-0.92) but not noncomplex PCI (HR, 0.91; 95% CI, 0.77-1.08), albeit there was no evidence of interaction (P interaction = 0.281)., Conclusions: Despite the use of contemporary techniques, acute coronary syndrome patients who undergo complex PCI had significantly higher rates of 1-year MACE. Adjusted magnitude of treatment effects with prasugrel vs clopidogrel were consistent in complex and noncomplex PCI without evidence of interaction., (Copyright © 2018. Published by Elsevier Inc.)

Objectives: This study sought to compare clinical outcomes in a contemporary acute coronary syndrome (ACS) percutaneous coronary intervention (PCI) cohort stratified by chronic kidney disease (CKD) status., Background: Patients with CKD exhibit high risks for both thrombotic and bleeding events, thus complicating decision making regarding antiplatelet therapy in the setting of ACS., Methods: The PROMETHEUS study was a multicenter observational study comparing outcomes with prasugrel versus clopidogrel in ACS PCI patients. Major adverse cardiac events (MACE) at 90 days and at 1 year were defined as a composite of death, myocardial infarction, stroke, or unplanned revascularization. Clinically significant bleeding was defined as bleeding requiring transfusion or hospitalization. Cox regression multivariable analysis was performed for adjusted associations between CKD status and clinical outcomes. Hazard ratios for prasugrel versus clopidogrel treatment were generated using propensity score stratification., Results: The total cohort included 19,832 patients, 28.3% with and 71.7% without CKD. CKD patients were older with greater comorbidities including diabetes and multivessel disease. Prasugrel was less often prescribed to CKD versus non-CKD patients (11.0% vs. 24.0%, respectively; p < 0.001). At 1 year, CKD was associated with higher adjusted risk of MACE (1.27; 95% confidence interval: 1.18 to 1.37) and bleeding (1.46; 95% confidence interval: 1.24 to 1.73). Although unadjusted rates of 1-year MACE were lower with prasugrel versus clopidogrel in both CKD (18.3% vs. 26.5%; p < 0.001) and non-CKD (10.9% vs. 17.9%; p < 0.001) patients, associations were attenuated after propensity stratification. Similarly, unadjusted differences in 1-year bleeding with prasugrel versus clopidogrel (6.0% vs. 7.4%; p = 0.18 in CKD patients; 2.6% vs. 3.5%; p = 0.008 in non-CKD patients) were not significant after propensity score adjustment., Conclusions: Although risks for 1-year MACE were significantly higher in ACS PCI patients with versus without CKD, prasugrel use was 50% lower in patients with renal impairment. Irrespective of CKD status, outcomes associated with prasugrel use were not significant after propensity adjustment. These data highlight the need for randomized studies evaluating the optimal antiplatelet therapy in CKD patients with ACS., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Novel approaches to observational studies and clinical trials could improve the cost-effectiveness and speed of translation of research. Hybrid designs that combine elements of clinical trials with observational registries or cohort studies should be considered as part of a long-term strategy to transform clinical trials and epidemiology, adapting to the opportunities of big data and the challenges of constrained budgets. Important considerations include study aims, timing, breadth and depth of the existing infrastructure that can be leveraged, participant burden, likely participation rate and available sample size in the cohort, required sample size for the trial, and investigator expertise. Community engagement and stakeholder (including study participants) support are essential for these efforts to succeed., (Copyright © 2015. Published by Elsevier Inc.)

Background and Aim: Physical activity or exercise is a proven deterrent of cardiovascular diseases. The purpose of this study was to examine whether vitamin E supplementation interfere with the potential benefits of exercise., Methods and Results: A total of 455 apparently healthy men and women were recruited, for a 2-month aerobic/cardiovascular exercise program. Subjects were randomly assigned for soft gel vitamin E or placebo (800 IU), and required to give blood at 0, 2, 4 and 8 weeks of exercise. Levels of lipid and markers of oxidative stress and inflammation were measured along with the VO2 and duration time spent on treadmill. Statistical analysis did not show significant changes in the levels of lipids and markers of oxidative stress and inflammation. Favorable trends among both of the randomization groups were observed in lipids, and some of the oxidative stress and inflammatory markers. This study also established several interesting correlations between VO2, and lipids on one hand and markers of oxidation and inflammation on the other hand. Reduction in LDL levels positively associated with increased levels of MCP-1 (P < 0.008) among placebo group, and also decreased hCRP levels strongly correlated with the increases in VO2 (P < 0.0004) among the placebo, and vitamin E subjects (P < 0.01)., Conclusions: Exercise training induces oxidative stress might be instrumental in favorable lipid reduction and markers of oxidative stress and inflammation. However interestingly, vitamin E didn't demonstrate favorable effects on the level of oxidative stress and inflammation associated with exercise., (Copyright © 2011 Elsevier B.V. All rights reserved.)

Objective: The purpose of this study was to test the hypothesis that the higher prevalence of medical comorbidities among black women accounts for their increased risk of prematurity., Study Design: A population-based regional cohort of women receiving obstetric care for singleton pregnancies at a large community hospital between 2003 and 2006 were analyzed using univariate and multivariable logistic regression., Results: Data for 18,624 consecutive births found increased odds of adverse outcomes for black compared to white women: prematurity OR = 1.6 (1.4-1.8), extreme prematurity OR = 2.5 (2.0-3.2). Logistic regression modeling identified black race, age < 20, preconception diabetes and hypertension, smoking, underweight, and gestational hypertension as the greatest risks for adverse outcomes. Controlling for these risks did not attenuate the higher risk for prematurity among blacks., Conclusion: Though there is a greater burden of health risk among black women, this did not account for the higher rates of low birthweight and prematurity.

Background: This retrospective study compared clinical outcomes and resource utilization in patients having off-pump coronary artery bypass grafting (OPCAB) versus conventional coronary artery bypass grafting (CABG). Angiographic patency was documented in the OPCAB group., Methods: From April 1997 through November 1999, OPCAB was performed in 200 consecutive patients, and the results were compared with those in a contemporaneous matched control group of 1,000 patients undergoing CABG. Patients were matched according to age, sex, preexisting disease (renal failure, diabetes, pulmonary disease, stroke, hypertension, peripheral vascular disease, previous myocardial infarction, and primary or redo status. Follow-up in the OPCAB patients was 93% and averaged 13.4 months., Results: Hospital death (1.0%), postoperative stroke (1.5%), myocardial infarction (1.0%), and re-entry for bleeding (1.5%) occurred infrequently in the OPCAB group. There were reductions in the rates of transfusion (33.0% versus 70.0%; p < 0.001) and deep sternal wound infection (0% versus 2.2%; p = 0.067) in the OPCAB group compared with the CABG group. Angiographic assessment of 421 grafted arteries was performed in 167 OPCAB patients (83.5%) prior to hospital discharge. All but five were patent (98.8%) (93.3% FitzGibbon A, 5.5% FitzGibbon B, 1.2% FitzGibbon O). All 163 internal mammary artery grafts were patent. Off-pump coronary artery bypass grafting reduced postoperative hospital stay from 5.7 +/- 5.3 days in the CABG group to 3.9 +/- 2.6 days (p < 0.001), with a decrease in hospital cost of 15.0% (p < 0.001)., Conclusions: Off-pump coronary artery bypass grafting reduces hospital cost, postoperative length of stay, and morbidity compared with CABG on cardiopulmonary bypass. Off-pump coronary bypass grafting is safe, cost effective, and associated with excellent graft patency and clinical outcomes.

Purpose: This study estimated the association between age and in-hospital postoperative complications, controlling for known or suspected risk factors, in a series of patients undergoing elective abdominal aortic reconstructive surgery (AAR)., Methods: This retrospective cohort study of outcome data with multivariate logistic regression analysis was conducted at Emory University Hospital, a tertiary care, university-affiliated hospital. All patients undergoing elective AAR between Jan 1, 1986, and Aug 1, 1996, were included (n = 856). An estimate of the odds ratio (OR) and 95% CI for the association between patient age and in-hospital major morbidity or mortality after elective AAR was made, controlling for significant risk factors., Results: Among the 856 patients, 170 had a nonfatal complication (136 with major and 34 with minor complications), and 11 patients (1.3%) died. The final logistic regression model demonstrated a mild association between increasing age and rate of major postoperative complications, including death (for each increase in age of 10 years: OR, 1.23; 95% CI, 1.00-1.52; P =.052). Other significant covariates in the final model included cardiac disease (OR, 2.84; 95% CI, 1.18-6.86; P =.020), pulmonary disease (OR, 1.96; 95% CI, 1.35-2.84; P =.0004), and renal disease (OR, 2.57; 95% CI, 1.66-3.99; P =.0001). Increasing age was associated with a moderate increase in the rate of death (for each increase in age of 10 years: OR, 2.74; 95% CI, 1.22-6.16; P =.015) in a model with cardiac disease as the only significant covariate (OR, 14.67; 95% CI, 3.46-62.16; P =.0003)., Conclusion: For patients undergoing elective AAR, increasing patient age is associated with a small increase in risk for in-hospital morbidity or mortality. However, significant cardiac, pulmonary, or renal disease is associated with a much greater risk of postoperative complications, and, therefore, advanced age should not be the sole basis of exclusion for otherwise suitable candidates for elective AAR.

Background: Outcomes and resource utilization of patients undergoing mitral valve replacement (MVR) with or without concomitant coronary artery bypass grafting (CABG) were reviewed., Methods: Data for 1,844 patients undergoing isolated primary MVR at Emory University Hospitals between 1980 and 1997 were recorded prospectively in a computerized database., Results: The four groups included patients undergoing elective MVR with (n = 360) or without CABG (n = 1332) and urgent/emergent MVR with (n = 66) or without CABG (n = 86). Length of stay was significantly higher in patients undergoing elective MVR with CABG (15 days) than in those without CABG (11 days) but was not significantly different in patients undergoing urgent/emergent MVR with CABG (17 days) than in those without CABG (19 days). In-hospital mortality was significantly higher for patients undergoing elective (14%) or urgent/emergent (41%) MVR with CABG than in those undergoing MVR without CABG (elective:6%; urgent/emergent:20%). The 19-year survival rate was 32% for patients undergoing elective MVR with CABG compared with 51% for those without CABG and 28% for patients undergoing urgent/emergent MVR with CABG compared with 46% for those without CABG. Multivariate correlates of long-term mortality included older age, concomitant CABG, and urgent/emergent status. Hospital costs were significantly higher for patients undergoing elective MVR with ($33,216) than for those without ($23,890) CABG. No significant difference in cost were noted between patients undergoing urgent/emergent MVR with ($40,535) and without ($31,981) CABG., Conclusions: The addition of CABG or urgent/emergent status to patients undergoing MVR significantly increases morbidity, mortality, and costs. Careful scrutiny of the benefits versus resource utilization is required for patients undergoing high risk MVR.

Background: There has been increasing concern in recent years about the quality and cost of heart valvular replacement procedures. The purpose of this study is to examine the profile of patients undergoing valvular operations during the past decade, and to look at trends in outcome and resource utilization over that period., Methods: Clinical and procedural data of 2,972 patients undergoing heart valve replacement at Emory University Hospitals between 1988 and 1997 were recorded prospectively on standardized forms by trained medical personnel and entered into a computerized database., Results: There were 1,802 patients undergoing aortic valve replacement (AVR), 966 undergoing mitral valve replacement (MVR), and 204 undergoing combined aortic and mitral valve procedures (AVR + MVR). No patients were excluded. There was a statistically significant trend for patients undergoing AVR, MVR, or AVR + MVR over time to be older and sicker by multiple criteria. Nonetheless, procedural outcome and inhospital mortality for patients undergoing AVR remained unchanged. Cost and length of stay increased from 1988 to 1992 when a concerted effort to decrease resource utilization began. Between 1992 and 1997 for AVR, length of stay decreased from 13.4 to 8.0 days and cost from $37,047 to $21,856. Similarly, between 1992 and 1997 for MVR, length of stay decreased from 15.6 to 8.1 days and cost from $45,072 to $21,747. The net result over the time period from 1988 to 1997 was an average decline in the cost of operation of $785 a year, adjusted for other factors., Conclusions: This study reveals that outcome of valvular replacement during the period from 1988 to 1997 has remained constant despite the patients becoming older and sicker during the same period. This constant outcome has been accomplished, but length of stay has decreased significantly. Hospital costs increased during the first years of the study period, but then decreased to levels in 1997 that were equal to or significantly less than 1988 levels.

Background: Stroke is a major complication of coronary operation, with reported rates of postoperative cerebral dysfunction ranging from 0.4% to 13.8%. In this report, the incidence, correlates, outcomes, and costs of stroke in coronary operation were evaluated at Emory University between 1988 and 1996., Methods: Data were entered prospectively into a dedicated computerized database at Emory University and analyzed retrospectively. Univariate and multivariate analyses were utilized where appropriate., Results: Data from 10,860 patients undergoing primary coronary operation between 1988 and 1996 were analyzed. There were 250 patients not entered into the database. Stroke occurred in 244 (2.2%). Univariate predictors of stroke (p<0.05) included age, female gender, hypertension, diabetes, prior stroke, prior transient ischemic attack (TIA), and carotid bruits. Multivariate correlates included age (odds ratio 1.07) previous TIA (odds ratio 2.2), and carotid bruits (odds ratio 1.9), although the area under the Receiver Operating Characteristics (ROC) curve was only 0.69, suggesting limited ability to predict stroke. One and 5 year survival rates were 64% and 44% with stroke, and 94% and 81% without stroke, respectively. Among the stroke group, 23% of the patient population died before hospital discharge. The stroke group had a significantly longer length of hospital stay, as well as higher costs., Conclusions: Stroke is a devastating complication of coronary operation, significantly increasing morbidity, mortality, and cost. Three independent variables were identified for predicting stroke, including age, previous TIA, and carotid bruits. Patients should be carefully screened for cerebrovascular disease to help prevent stroke and its associated morbidity.

Background: Diabetes mellitus is an established independent risk factor for significant morbidity and mortality after coronary artery bypass grafting., Methods: The impact of diabetes on short- and longterm follow-up after coronary artery bypass grafting was studied by comparing the outcomes between 9,920 patients without diabetes mellitus and 2,278 patients with diabetes from 1978 to 1993., Results: Compared with nondiabetic patients, the group with diabetes was older (62+/-10 years versus 60+/-10 years), comprised more women (31% versus 19%), had a greater incidence of hypertension (61% versus 44%) and previous myocardial infarction (51% versus 48%), had class III-IV angina more commonly (69% versus 63%), showed a higher incidence of congestive heart failure (11% versus 5%) or triple-vessel or left main disease (60% versus 50%), and had lower ejection fractions (0.54 versus 0.57) (all, p< or =0.05). Diabetic patients had a higher incidence of postoperative death (3.9% versus 1.6%) and stroke (2.9% versus 1.4%) (both, p< or =0.05), but not Q wave myocardial infarction (1.8% versus 2.9%). Diabetics had lower survival (5 years, 78% versus 88%; 10 years, 50% versus 71%; both, p< or =0.05) and lower freedom from percutaneous transluminal coronary angioplasty (5 years, 95% versus 96%; 10 years, 83% versus 86%; latter, p< or =0.05), but diabetics did not have lower freedom from either myocardial infarction (5-years, 92% versus 92%; 10-years, 80% versus 84%) or additional coronary artery bypass grafting (5-years, 98% versus 99%; 10-years, 90% versus 91%). Multivariate correlates of long-term mortality were diabetes, older age, reduced ejection fraction, hypertension, congestive heart failure, number of vessels diseased, and urgent or emergent operation., Conclusions: Diabetics have a worse hospital and longterm outcome after coronary artery bypass grafting. The increased risk in such patients can only partially be explained by other demographic characteristics.

Background: Cardiac valve replacement and coronary artery bypass graft surgery (CABG) are being applied with increasing frequency in patients 80 years of age and older., Methods: Six hundred one consecutive patients older than 80 years, undergoing cardiac surgery between 1976 and 1994 (CABG with saphenous vein graft, 329 [54.7%]; CABG with left internal mammary artery, 101 [16.8%]; CABG + valve, 80 [13.3%]; isolated aortic valve replacement, 71 [11.8%]; isolated mitral valve replacement, 18 [3.0%]), were studied retrospectively to assess short- and long-term survival. They were compared with 11,386 patients aged 60 to 69 years and 5,698 patients aged 70 to 79 years undergoing similar procedures during the same time interval., Results: In comparison with patients 60 to 69 years old, more octogenarians were women (44.4% versus 25.6%, p<0.0001), had class IV angina (54.1% versus 38.9%, p<0.0001), and had congestive heart failure class IV (4.9% versus 3.0%, p = 0.0001). In-hospital death rates (9.1% versus 3.4%, p<0.0001) and stroke (5.7% versus 2.6%, p<0.0001) reflected these adverse clinical risk factors. However, Q-wave infarction tended to be less frequent (1.5% versus 2.6%, p = 0.102). Interestingly, hospital mortality (9.1% versus 6.7%, p = 0.028) was only slightly increased, and stroke (5.7% versus 4.7%, p = 0.286) was not more common in octogenarians than in patients 70 to 79 years old. Late-survival curves have similar slopes for the first 5 years in all clinical subgroups. However, after 5 years there is a more rapid decline in octogenarians than in younger age groups. Median 5-year survival was 55% for patients older than 80 years, 69% for patients 70 to 79 years, and 81% for patients 60 to 69 years old., Conclusions: When appropriately applied in selected octogenarians, cardiac surgery can be performed with acceptable mortality and excellent 5-year survival.

Objective: The aim of this study was to determine the long-term survival and control of angina in patients with coronary artery disease and sequentially decreased ejection fractions (EF) after first-time coronary artery bypass grafting., Methods: Between 1981 and 1995, 156 (1.3%) patients with an EF less than 0.25 (group 1), 588 (5%) patients with an EF of 0.25 to 0.34 (group 2), 2,438 (20.6%) patients with an EF of 0.35 to 0.49 (group 3), and 8,648 (73.1%) patients with an EF equal to or greater than 0.50 (group 4) underwent coronary artery bypass grafting. The EFs were determined by uniplanar or biplanar left ventriculography. For each group, the clinical and angiographic characteristics and the operative and outcome data were compared. Survival curves were derived and compared for each group. Correlates of angina, and of early (30-day) and long-term mortality, for all groups were analyzed., Results: For all groups the mean age was approximately 60+/-10 years. Group 1 had the highest percentage of patients who were men (88%), had congestive heart failure (34%), had hypertension (53%), and had left main coronary artery disease (24%). Groups 1 through 3, compared with group 4, had a lower percentage of complete revascularization (p < 0.0001), a lower percentage of internal mammary artery grafts (p < 0.0001), and a greater use of intraaortic balloon pump (p < 0.0001), but had similar cross-clamp and cardiopulmonary bypass times, number of grafts, incidences of myocardial infarction, and stroke. Hospital mortality for groups 1, 2, 3, and 4 was 3.8% (n = 6), 3.4% (n = 20), 3% (n = 72), and 1.6% (n = 134), respectively. Groups 1 through 3, compared with group 4, had similar incidences of angina during follow-up (31% to 40% versus 33%, respectively; p < 0.06). Survival was greatest for group 4 compared with groups 1 through 3 at 1, 5, and 10 years (p < 0.0001). Patients in group 1 had 1-, 5-, and 7-year survivals of 90%, 64%, and 49%. Multivariate correlates of early mortality were advanced age, female sex, decreased EF, hypertension, diabetes, and emergency operation. Multivariate correlates of long-term mortality included severity of preoperative angina class, congestive heart failure, number of diseased vessels, and incomplete revascularization. The strongest correlates of angina at follow-up were younger age, female sex, previous myocardial infarction, lower ejection fraction, and incomplete revascularization. The absence of an internal mammary artery graft did not predict the occurrence of angina or influence long-term survival., Conclusions: In the long term there is a higher mortality in patients with sequentially decreased left ventricular function undergoing coronary artery bypass grafting, although more than 60% of patients with an EF less than 0.25 were alive and had good control of angina at 5 years despite having a higher percentage of risk factors, poorer functional status, and more complex coronary disease. Failure of symptom control and survival beyond 5 years appeared to be influenced by preexisting medical conditions and factors that affect the ability to completely revascularize the myocardium. These results suggest that in selected patients with ischemia and poor left ventricular function, coronary artery bypass grafting may preserve remaining viable myocardium, provide relief of symptoms, and offer survival greater than 60% at more than 5 years.

Background: Increasingly, patients are returning for a second, third, and even fourth coronary artery bypass graft (CABG) procedure., Methods: This report reviews the in-hospital and long-term outcomes for 102 patients undergoing a third or fourth CABG at Emory University from December 1977 to April 1994., Results: The mean interval from the first to second CABG was 5.2 +/- 3.5 years and from the second to the third CABG 6.8 +/- 4.1 years. The mean age was 6 +/- 9 years, 91% were male, 33% had hypertension, 16% diabetes, 86% class III or IV angina (Canadian Cardiovascular Society), 4.4% congestive failure (New York Heart Association), and 73% three-vessel disease. The in hospital mortality rate was 9.8%, with a perioperative myocardial infarction rate of 8.8% and a stroke rate of 1.9%., Conclusions: These perioperative mortality and myocardial infarction rates are several times higher than those reported for initial revascularizations or first-time redo CABG operations. However, the 5- and 10-year survival rates of 79% and 59%, respectively, and a myocardial infarction-free survival of 62% at 5 years, the benefits of a third-time CABG procedure are apparent for this high-risk group of patients.

Noninvasive testing is often evaluated by the sensitivity and specificity in comparison with a more invasive, but more definitive "gold" standard. However, work-up or verification bias, which occurs when the results of a noninvasive test impact the decision to perform the gold standard invasive test, increases the "observed" sensitivity and decreases the "observed" specificity of the noninvasive test. Most large clinical studies utilizing a noninvasive technique to diagnose coronary artery disease have biases, particularly work-up bias. To obtain more accurate measurements of sensitivity and specificity, we determined the observed sensitivity and specificity of stress (exercise and dipyridamole) single photon emission computed tomographic (SPECT) thallium testing for the detection of coronary artery disease by angiography, and then applied previously published equations to correct for work-up bias. From a computerized data base, reports of 4354 stress SPECT thallium studies from January 1, 1986 through December 31, 1992 were reviewed. All patients with a known history of myocardial infarction or prior coronary angiography were excluded, leaving 2688 patients. From this total, 471 patients underwent coronary angiography within 90 days following stress SPECT thallium testing. Coronary artery disease was defined as a visually assessed stenosis of a coronary artery or a major branch > 50%. Of the 2688 stress SPECT thallium studies, 1265 were normal and 1423 were abnormal. For the 471 patients who underwent catheterization within 90 days following stress SPECT thallium testing. the "observed" sensitivity and specificity were 98 and 14%, respectively. After correction for work-up bias, the corrected sensitivity and specificity were 82 +/- 6% and 59 +/- 2%, respectively. Most studies utilizing noninvasive technologies for the detection of coronary artery disease include patients with known coronary artery disease and have work-up bias as well. By knowing the thallium results of patients with and without catheterization, we were able to correct for work-up bias. These data provide better estimate of the sensitivity and specificity of stress SPECT thallium testing.

Background: Intracoronary stents are being used to treat acute and threatened closure after percutaneous transluminal coronary angioplasty and to prevent restenosis., Methods: The outcomes of 68 patients having coronary artery bypass grafting after stent placement were reviewed. The mean age was 60.5 +/- 9.7 years, and 71% were male. Thirty-seven percent had hypertension, 13% had diabetes, 62% had class III or IV angina, 60% had multivessel disease, and 40% had sustained a prior myocardial infarction. Fifty-three patients underwent emergency operation, 22 with hemodynamic collapse immediately after percutaneous transluminal coronary angioplasty, and 7 others required urgent revascularization within 24 hours of angioplasty. Seventeen underwent coronary artery bypass grafting for acute closure of the stented vessel several days after the angioplasty procedure., Results: There was no correlation between urgency of the procedure, previous infarction, or previous coronary artery bypass grafting with successful procedure. The in-hospital mortality was 4.4%, 21% had a Q-wave myocardial infarction, and 1.5% sustained a stroke. Ejection fraction was the only correlate of long-term mortality., Conclusions: Coronary artery injury for which stents are placed for acute or threatened occlusion or to prevent restenosis but then fail, thus necessitating coronary artery bypass grafting, can be treated successfully. Although the rate of Q-wave myocardial infarction is substantial and related to the initial ischemic insult, the long-term survival and event rates are excellent with prompt surgical revascularization.

Warm heart surgery has documented myocardial protection benefit, but with an added neurologic threat. It is hypothesized that moderately hypothermic aerobic heart surgery will maintain the myocardial protection and reduce neurologic risk. This study compared 493 patients undergoing coronary artery bypass graft operations with normothermic (35 degrees to 37% degrees C) continuous blood cardioplegia and normothermic perfusion to 379 coronary artery bypass grafting patients with hypothermic (33 degrees to 29 degrees C) continuous blood cardioplegia and hypothermic perfusion to test this hypothesis. There was no difference in age, sex, prior myocardial infarction, hypertension, prior neurologic event, congestive failure, or diabetes. The hypothermic group had more reoperations (24% versus 14%; p = 0.0002), class III/IV angina (83% versus 71%; p = 0.002), a trend to more triple-vessel (54% versus 47%; p = 0.10) and left main disease (18% versus 14%; p = 0.10), lower ejection fractions (0.52 +/- 0.15 versus 0.55 +/- 0.13), more grafts placed (3.6 +/- 1.1 versus 3.4 +/- 1.1; p = 0.04), but fewer internal mammary arteries (62% versus 78%; p < 0.0001). Postoperative myocardial infarction rate was 1.2% in the hypothermic group and 1.3% in the normothermic group (p = not significant). Intraaortic balloon pump requirement was 3.4% with hypothermic and 1.4% with normothermic groups (p = 0.05). The incidence of postoperative neurologic events was significantly higher in the normothermic group (4.7% versus 1.8%; p = 0.038). The multivariate correlates of stroke were older age and normothermic cardioplegia, whereas the only multivariate correlate of death was older age.(ABSTRACT TRUNCATED AT 250 WORDS)

The interaction of patient age and the presence of coronary artery disease (CAD) and its influence on survival were examined in 3,644 patients undergoing either aortic (AVR) or mitral (MVR) valve replacement with or without coronary artery bypass grafting (CABG) between 1974 and 1991. Emergency procedures were performed much more frequently in those undergoing MVR and CABG than in those undergoing AVR and CABG (18.8% and 6.7%, respectively). The adverse effect of CAD on median survival for patients of all ages undergoing either AVR or MVR was statistically significant (AVR without CAD 11.8 versus 8.7 years with CAD; MVR without CAD 12.7 versus 7.3 years with CAD; p < 0.0001). Survival in patients younger than 70 years without CABG who underwent either AVR or MVR was quite good (< 60 years: AVR, > 14 years; MVR, 15.4 years; 60 to 69 years: AVR, 10.4 years; MVR, 11.4 years). The most profound effect of CAD on patient survival after valve replacement was observed in patients 60 to 69 years of age who underwent MVR, in whom the median survival without CABG was 11.4 years versus 5.5 years with CABG (p < 0.0001). An emergency operative status was associated with a reduced early and late survival for those patients undergoing MVR, particularly those with CAD. By relating the Cox proportional hazard models for valve survival to patient survival, we found that, in those patients 70 years and older with and without CAD who underwent either AVR or MVR, the median patient survival was reduced sufficiently (5.5 versus 8.1 years) to justify use of a bioprosthetic valve.(ABSTRACT TRUNCATED AT 250 WORDS)

From March 1991 through July 1992, 1,001 patients having elective coronary artery bypass grafting were randomized to receive either continuous warm (> or = 35 degrees C) blood cardioplegia with systemic normothermia (> or = 35 degrees C) or intermittent cold (< or = 8 degrees C) oxygenated crystalloid cardioplegia and moderate systemic hypothermia (< or = 28 degrees C). Preoperative variables including age, sex, prior coronary bypass grafting, hypertension, prior myocardial infarction, diabetes, angina class, and preoperative heart failure class were similar in both groups, as were the intraoperative variables of number of coronary grafts, mammary artery use, and cardiopulmonary bypass time. Aortic cross-clamp time was significantly longer in the warm group (46 +/- 23 minutes versus 40 +/- 21 minutes). Most postoperative variables including mortality (warm, 1.0%, and cold, 1.6%), Q wave infarction (warm, 1.4%, and cold, 0.8%), and need of an intraaortic balloon pump (warm, 1.4%, and cold, 2.0%) were similar between groups. Total neurologic events (warm, 4.5%, and cold, 1.4%; p < 0.005) and perioperative strokes (warm, 3.1%, and cold, 1.0%; p < or = 0.02) were significantly higher in the warm group. Neurologic events included perioperative stroke (warm, 15 patients, and cold, 5 patients; p < 0.02), perioperative encephalopathy (warm, 2 patients, and cold, 1 patient), and delayed (> or = 3 in-hospital days) stroke (warm, 5 patients, and cold, 1 patient). All patients experiencing a stroke had a persistent neurologic deficit at the time of discharge. Encephalopathy resolved completely in all instances.(ABSTRACT TRUNCATED AT 250 WORDS)

This study was undertaken to more clearly define the operative risks and appropriate strategies for the selection of patients who might be candidates for bilateral internal mammary artery grafting. A review of the 674 patients who underwent this procedure was performed over a 10-year period from January 1982 through 1991. These patients represented 5% of the 12,824 patients who underwent bypass grafting during this period. The mean patient age was 54 +/- 9.4 years, and 92% of the patient were male. Diabetes was present in 17.5%, with 24% of this group insulin dependent. The ejection fraction was less than 0.50 in 26.7% and 14% had had previous bypass procedures. Hospital mortality was 1.9% (n = 13). Hospital morbidity included wound infection in 3.6%, reoperation for bleeding in 2.1%, and stroke in 1.6%. Postoperative intraaortic balloon pump support was necessary in 2.8%. Univariate and multivariate analysis revealed that advanced age, an emergent operative status, and the number of diseased vessels (especially left main obstruction) were predictors of hospital death. Except for wound infection (9.3% versus 2.5%) and length of hospital stay (10.8 +/- 11.8 days versus 8.8 +/- 7.6 days), the complications in diabetics were similar to those in patients without diabetes, respectively. At 5 years, freedom from death, death or infarctions, and death, myocardial infarction, or coronary reoperation was 90%, 70%, and 62%, respectively. The only significant multivariate correlates of long-term survival were diabetes and reoperative surgery.

Purpose: The purpose of this study was to retrospectively evaluate the effectiveness of screening for coronary artery disease before elective repair of abdominal aortic aneurysms (AAA) was performed., Methods: Results of a screening algorithm for coronary artery disease in 263 patients admitted to a single hospital for elective repair of AAA between January 1986 and December 1989 were analyzed. Patients with no coronary artery disease indicators proceeded to surgery without further workup. Patients with cardiac disease indicators underwent dipyridamole-thallium scintigraphy, and patients with angina were screened by use of cardiac catheterization; those with a recent coronary revascularization underwent no additional screening unless symptoms or electrocardiographic changes suggested an intervening event. Twenty-eight patients underwent no screen other than medical history and electrocardiogram., Results: Among 164 patients screened with dipyridamole-thallium scintigraphy, 44 patients had redistribution defects that required catheterization, and 11 of these underwent coronary revascularization. Cardiac catheterization was performed directly in 42 patients, which led to 11 revascularizations before AAA repair. Previous coronary artery bypass or percutaneous transluminal angioplasty obviated additional screening in 29 patients. Of the 263 scheduled AAA repairs, 15 were cancelled because of unacceptable operative risks, 13 for cardiac reasons. One patient died of a ruptured AAA after an uneventful coronary artery bypass. Among the 247 AAA repairs performed, there were three perioperative deaths (1.2%), all of which resulted from sudden cardiac events; three additional patients had nonfatal myocardial infarctions (1.2%), for a total cardiac complication rate of 2.4%., Conclusions: The low rate of cardiac complications in this experience affirms the effectiveness of preoperative screening and selective coronary revascularization before AAA repair.

Initial reoperative coronary artery bypass grafting is being performed commonly, and an increasing number of patients are being referred for subsequent reoperative coronary artery bypass grafting. From January 1980 through June 1990, 53 patients (52 male, 1 female) underwent a third or fourth coronary artery bypass operation and were retrospectively reviewed. This represented 0.3% (53/17,102) of the coronary artery bypass procedures done during that time period. The mean age was 59 +/- 8 years. The number of grafts placed ranged from one to four with an average of 2.6 per patient. Internal mammary artery grafts were used in 30 patients (57%). The mean left ventricular ejection fraction was 0.52 +/- 0.13. Intraaortic balloon pump support was necessary in 10 patients postoperatively. There were no intraoperative deaths, although 4 patients died in the postoperative hospitalization period. Perioperative myocardial infarctions were diagnosed in 6 patients, 13 patients had perioperative dysrhythmias, and 2 patients sustained a stroke. Superficial wound infections occurred in 5 patients. Late follow-up in 49 patients revealed that 2 other patients have since died, and no further myocardial infarctions have been reported in the survivors. Postoperative 3-year survival is 85%, whereas 3-year myocardial infarction-free survival is 70%. Although there is increased risk of operative complications and early death after multiple reoperative coronary artery bypass grafting, both in-hospital and long-term results suggest that it is an appropriate therapeutic strategy.

Carpentier's techniques of prosthetic ring mitral valve repair for mitral regurgitation offer the potential for immediate and long-term improvement in valve function without the necessity of replacing the native valve with a prosthesis. A consecutive, case-matched series of 65 patients with prosthetic ring mitral valve repair was compared with 65 patients undergoing mitral valve replacement for mitral regurgitation. The aortic cross-clamp time was 57 +/- 33 minutes in the repair operations and 41 +/- 25 minutes in the replacement operations (p = 0.003). The cardiopulmonary bypass time was 154 +/- 44 minutes in the repair operations and 113 +/- 41 minutes in the replacement operations (p = 0.0001). There were no myocardial infarctions in the hospital in either group. Hospital death was noted in 1.5% of repairs and 4.6% of replacements (p = not significant). Survival at 4 years was 0.84 for repairs and 0.82 for replacements (p = not significant). Freedom from reoperation to replace the mitral valve at 4 years was 62 of 65 patients in the repair group and 64 of 65 patients in the replacement group (p = not significant). In-hospital and midterm results in a closely matched population show that mitral valve repair yields results comparable with those of replacement despite a more difficult procedure. The benefits of maintaining the native valve with chordal and papillary muscle structure intact and avoidance of prosthetic valve implantation may then become apparent with longer follow-up.

The porcine bioprosthetic valve was used in 440 patients having isolated mitral valve replacement (MVR), 522 patients having isolated aortic valve replacement (AVR), and 88 patients having MVR + AVR between 1974 and 1981. Patients with associated surgical procedures were excluded. Mean follow-up was 8.3 years. At 10 years, there was no difference in patient survival between those having AVR and those having MVR. Reoperations were performed on 192 patients. Endocarditis was the reason for reoperation in 3.7% of patients who had MVR and 10.6% of those who had AVR. Structural valve degeneration was the reason for reoperation in 89.7% of MVR patients and 78.8% of AVR patients (p = 0.04). Hospital mortality among patients having valve reoperations was 4.7%. At 10 years, the freedom from valve reoperation for all causes and from structural valve degeneration was significantly better for the AVR group than the MVR group (74% +/- 3% versus 61% +/- 4%, p = 0.004; and 79% +/- 3% versus 63% +/- 4%, p = 0.0006, respectively). For patients in their 60s, the 10-year freedom from reoperation was 92% +/- 2% for AVR and 80% +/- 6% for MVR (p = not significant). At 10 years, freedom from cardiac-related death and valve reoperation was best for both MVR and AVR patients in their 60s. Patients 70 years old or older rarely had reoperation but died before valve failure occurred. The 10-year freedom from all major valve-related events (cardiac-related death, reoperation, thromboembolism, endocarditis, and anticoagulant-related bleeding) was practically the same for both MVR and AVR patients (48% +/- 3% versus 49% +/- 3%, respectively). The porcine bioprosthetic valve is the valve of choice only for patients 60 years old or older. Patients in their 70s have an extremely low rate of reoperation but a high rate of cardiac-related death and do not outlive the prostheses.