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Background: Some patients with severe symptomatic aortic stenosis (AS) do not undergo aortic valve replacement (AVR) despite demonstrated symptomatic and survival advantages and despite unequivocal guideline recommendations for surgical evaluation., Methods and Results: In 3 large tertiary care institutions (university, Veterans Affairs, and private practice) in Washtenaw County, Mich, patients were identified with unrefuted echocardiography/Doppler evidence of severe AS during calendar year 2005. Medical records were retrospectively reviewed for symptoms, referral for AVR, calculated operative risk for AVR, and rationale as to why patients did not undergo valve replacement. Of 369 patients with severe AS, 191 (52%) did not undergo AVR. Of these, 126 (66%, 34% of total) had symptoms consistent with AS. The most common reasons cited for absent intervention were comorbidities with high operative risk (61 patients [48%]), patent refusal (24 patients [19%]), and symptoms unrelated to AS (24 patients [19%]). Operated patients had a lower Society of Thoracic Surgery-calculated perioperative mortality risk than unoperated patients (1.8% [interquartile range, 1.0 to 3.0%] versus 2.7% [interquartile range, 1.6 to 5.5%], P<0.001). However, 28 (24%) of 126 unoperated symptomatic patients had a calculated perioperative risk less than the median risk for patients who underwent AVR. Only 57 (30%) of 191 unoperated patients were evaluated by a cardiac surgeon. There were similar rates of intervention across practice settings, and similar rates of unoperated patients despite symptoms and low operative risk., Conclusions: One third of patients with severe AS are symptomatic but do not undergo AVR, with similar findings in multiple practice environments. For most unoperated patients, objectively calculated operative risks did not appear prohibitive. Despite this, a minority of unoperated patients were referred for surgical consultation. Some patients with severe symptomatic AS may be inappropriately denied access to potentially life-saving therapy.

Background: Very elderly patients are increasingly referred for revascularization yet have been underrepresented in both prior percutaneous coronary intervention (PCI) and coronary bypass surgery (CABG) clinical trials. We pooled the largest PCI and CABG clinical registries in the United States to better understand revascularization procedure use, risks and outcomes in patients aged > or =75 years., Methods: Six PCI registries (n = 48,439) and 8 CABG registries (n = 180,709) voluntarily contributed all procedural data in patients aged > or =75 years from 1990 through 1999. Patient characteristics, procedural process, and inhospital mortality and morbidity outcomes were evaluated. Risk factors for mortality in elderly patients were identified and compared across registries using standardized multivariable logistic regression., Results: Between the years 1991 and 1999, the proportion of patients aged > or =75 years undergoing revascularization was on the rise (10% increase). Pooled estimates of inhospital mortality following PCI during this decade was 3.0% (range 1.5%-5.2% among databases), and following CABG was 5.9% (range 4.9%-8.4% among databases). Mortality rates declined significantly in older patients for both PCI and CABG over this decade. While process measures varied across registries, the most significant predictors of inhospital death (procedural urgency, left ventricular dysfunction, prior CABG) seemed consistent across all sites., Conclusion: Over the last decade, the use of coronary revascularization in elderly patients increased and outcomes improved. While age remains a determinant of procedural risk, this risk varies markedly among elderly patients, emphasizing the need for individualized risk assessments.

Unlabelled: Prompt myocardial reperfusion is the therapeutic goal for patients presenting with acute myocardial infarction (AMI). However, there remains a paucity of clinical data from single centers solely dedicated to a catheter-based reperfusion strategy. Therefore, we sought to identify significant predictors of in-hospital mortality, to determine the changing profile of patient demographics and to identify the mortality trend over time., Methods: Consecutive patients who underwent percutaneous coronary intervention (PCI) for an AMI between January of 1982 and December of 1999 were included in this multivariable analysis (excluding cardiogenic shock). AMI was defined as an evolving myocardial infarction within the preceding 24 hours. The primary endpoint for this analysis was in-hospital mortality., Results: There were 2,745 patients identified in this study, of which 8.3% (n = 228) were non-survivors. The significant multivariable predictors of in-hospital mortality included creatinine > 1.5 mg/dl [relative risk (RR), 5.7; 95% confidence interval (CI) 4.0 8.1], ejection fraction < 40% (RR, 6.6; 95% CI, 4.3 10.0), multivessel disease (RR, 2.8; 95% CI, 1.9 4.2), female (RR, 2.3; 95% CI, 1.6 3.1) and age > 70 years (RR, 1.6; 95% CI, 1.1 2.2). The incidence of patients with these high-risk characteristics increased in recent years; thus, the unadjusted slope of the mortality trend over 20 years was not significant. However, following adjustment for the temporal shift in high-risk variables, there was a significant reduction in the adjusted in-hospital mortality rate (RR, 0.89; 95% CI 0.8 0.98; p = 0.017). Despite the changing risk profile, the short-term mortality continues to improve for patients undergoing AMI PCI.

The Mid America Heart Institute (MAHI) is one of the first and largest hospitals developed and designed specifically for cardiovascular care. The MAHI hybrid model, which is a partnership between the not-for-profit Saint Luke's Health System, an independent academic medical center, and a private practice physician group, has been extremely successful in providing high-quality patient care as well as developing strong educational and research programs. The Heart Institute has been the leader in providing cardiovascular care in the Kansas City region since its inception in 1975. Although challenges in the future are substantial, it is felt that the MAHI is in an excellent position to deal with the serious issues in health care because of the Heart Institute, its facility, organization, administration, dedicated medical and support staff, and its unique business model of physician management. In part I, the authors described the background and infrastructure of the Heart Institute. In part II, cardiovascular research and benefits of physician management are addressed.

The Mid America Heart Institute (MAHI) is one of the first and largest hospitals developed and designed specifically for cardiovascular care. The MAHI hybrid model, which is a partnership between the not-for-profit Saint Luke's Health System, an independent academic medical center, and a private practice physician group, has been extremely successful in providing high-quality patient care as well as developing strong educational and research programs. The Heart Institute has been the leader in providing cardiovascular care in the Kansas City region since its inception in 1975. Although challenges in the future are substantial, it is felt that the MAHI is in an excellent position to deal with the serious issues in health care because of the Heart Institute, its facility, organization, administration, dedicated medical and support staff, and its unique business model of physician management. In part I, the authors describe the background and infrastructure of the Heart Institute. In part II, cardiovascular research and benefits of physician management will be addressed.

Background: Numerous studies have demonstrated that patients with diabetes have higher rates of restenosis, late myocardial infarction, and late death after percutaneous coronary interventions (PCI). However, it remains unclear whether patients with diabetes mellitus also have an increased hazard for early death after either elective or urgent PCI., Methods: Patients undergoing PCI at the Mid American Heart Institute between 1980 and 1999 were identified. The main end point was inhospital death. Patients were stratified both by diabetes status and whether they underwent elective or urgent PCI., Results: There were 17,341 nondiabetic patients and 4308 patients with diabetes who underwent elective PCI. There were 2946 nondiabetic patients and 628 patients with diabetes who underwent urgent PCI. Multivariate analysis demonstrated that diabetes was associated with increased inhospital mortality rate after any PCI (odds ratio 1.4, 95% CI 1.1-1.8, P =.003). The unadjusted inhospital mortality rates for the nondiabetic patients and patients with diabetes were 0.8% and 1.4%, respectively (P <.001), after elective PCI. The mortality rate was 6.9% for the nondiabetic patients and 12.7% for the patients with diabetes (P <.001) after urgent PCI. The inhospital mortality rates among diabetic patients appear to be decreasing over time among the elective cohort (elective PCI diabetes-time interaction, P =.007) but not in the urgent cohort (urgent PCI-diabetes-time interaction, P =.68)., Conclusions: There has been an improvement in the inhospital survival rate among patients with diabetes in the elective PCI cohort. This improved hospital survival has yet to be realized among patients with diabetes undergoing urgent PCI.

Objectives: We sought to evaluate the results of percutaneous coronary intervention (PCI) in elderly patients in contemporary practice., Background: Prior studies of PCI in the elderly population demonstrate increased in-hospital mortality, but these studies are limited by small population size., Methods: Using the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR) of 100,253 patients, the in-hospital outcomes in all 8,828 PCI procedures performed on octogenarians were evaluated. Patients underwent PCI between 1998 and 2000 at over 145 participating centers., Results: The mean age was 83.72 +/- 3.02 years, with female preponderance (53%). The PCI was considered angiographically successful in 93%, stents were placed in 75%, and the post-PCI length of stay was 3.3 +/- 5.1 days. Overall in-hospital mortality was 3.77% but was only 1.35% in PCI without recent myocardial infarction (MI) within one week (p < 0.0001). Patients having PCI within 6 h of the onset of their MI had an increase in mortality tenfold (13.79%) compared with patients without a recent MI (p < 0.0001). All groups that were defined based on time of PCI after MI onset up to seven days had increased mortality (all p < 0.0001). Older age (odds ratio [OR] of 1.03 per incremental year), depressed ejection fraction (EF) (OR 0.69 per 10 points for EF <60%), and time of PCI after MI onset (<6 h, OR 6.87; 6 to 24 h, OR 5.66; 24 h to one week, OR 2.93) were most strongly predictive of outcome by multivariate analysis. The predicted mortality from the multivariate model correlated well with the observed in-hospital mortality up to 20% mortality. A 254-point nomogram was constructed employing the logistic model using a weighted point system., Conclusions: In patients > or = 80 years old, PCI has good success and acceptable mortality. The presence of an acute or recent MI substantially increases the risk of in-hospital death.

Background: Health status data are an increasingly important component of outcomes assessment and can be used to facilitate quality assessment and improvement efforts. An enormous challenge to the use of health status data among hospitalized patients, however, is collecting baseline data at the time of treatment, an essential component for risk-adjusting subsequent outcomes. The Mid America Heart Institute of Saint Luke's Hospital (Kansas City, Mo), attempted to integrate the collection of health status assessments within the process of performing coronary revascularization., The Data Collection Strategy: The data collection strategy was developed for each admission portalelective outpatients (admissions for same-day procedures), inpatients, and emergent cases. Health status data were collected on all patients with coronary artery disease who were receiving a percutaneous coronary intervention or coronary artery bypass graft with no disruption to physician scheduling or nursing staff., Results: In general, patients were agreeable to completing the health status survey. Despite initial efforts to educate the hospital staff about the goal and purpose of health status assessment, staff members who were unaware of the uses of these data seemed to minimize their value. Providing examples of how to use these data relative to the staff member's specific occupational role facilitated buy-in for this project., Epilogue: After the pilot study, which lasted until June 1999, data were continually collected for 18 months, through August 2000, even with the cessation of external grant funding for this project. Baseline data collection finally stopped, primarily because of a failure to accommodate data collection into the routine flow of patient care by existing nursing staff.

Objectives: The goal of this study was to learn more about the risk factors and short- and long-term outcomes for primary angioplasty., Background: Primary angioplasty (direct angioplasty without antecedent thrombolytic therapy) has been an effective alternative to thrombolytic therapy for patients with acute myocardial infarction (AMI). However, most reported studies have been compromised by small sample sizes and short observation times., Methods: New York's coronary angioplasty registry was used to identify New York patients undergoing angioplasty within 6 h of AMI between January 1, 1993 and December 31, 1996. Statistical models were used to identify significant risk factors for in-patient and long-term survival and to estimate long-term survival for all patients as well as various subsets of patients undergoing primary angioplasty., Results: The in-hospital mortality rate for all primary angioplasty patients was 5.81%. When patients in preprocedural shock (who had a mortality rate of 45%) were excluded, the in-hospital mortality rate dropped to 2.60%. Mortality rates for all primary angioplasty patients at one year, two years and three years were 9.3%, 11.3% and 12.6%, respectively. Patients treated with stent placement did not have significantly lower risk-adjusted in-patient or two-year mortality rates., Conclusions: Primary angioplasty is a highly effective option for AMI.

Objectives: We sought to compare patient outcomes for coronary stent placement and balloon angioplasty., Background: Since 1994, the number of patients treated only with balloon angioplasty has decreased nationally, whereas the use of coronary stents as an alternative has grown tremendously. The objectives of this study were to compare short- and long-term survival and subsequent revascularization rates for patients undergoing single-vessel balloon angioplasty and coronary stent placement., Methods: New York's Coronary Angioplasty Registry was used to identify New York patients undergoing either balloon angioplasty or stent placement between July 1, 1994, and December 31, 1996. Statistical models were used to compare risk-adjusted short- and long-term survival and subsequent coronary artery bypass graft surgery (CABG) and percutaneous coronary interventions (PCIs)., Results: No significant differences were found in adjusted in-patient mortality, but patients who had balloon angioplasty were, on average, 1.36 times more likely to have died at any time during the two-year period after the index procedure (p = 0.003). The adjusted in-patient CABG rate was significantly higher for balloon angioplasty (2.72% vs. 1.66%, p<0.0001), and the adjusted two-year CABG rate was also significantly higher for balloon angioplasty (10.81% vs. 7.25%, p<0.001). The adjusted two-year rate for subsequent PCIs was also significantly higher for balloon angioplasty (19.6% vs. 14.3%, p<0.0001). Although measures were taken to eliminate or minimize the effect of selection bias, it should be noted that patients with stents were healthier at hospital admission than patients who had balloon angioplasty., Conclusions: Stent placement is associated with significantly lower risk-adjusted long-term mortality, CABG and subsequent PCI rates, as compared with balloon angioplasty.

Background: Single-vessel coronary artery disease is usually treated with PTCA; however, this approach when applied to the left anterior descending coronary artery (LAD) is hampered by high restenosis rates, often approaching 50%. Coronary stenting (STENT) and left internal mammary artery bypass grafting of the LAD (LIMA-LAD) are other options that have been successfully used for single-vessel LAD disease. The optimal mode of revascularization for patients with isolated single-vessel LAD disease is unclear. The purpose of the present study was to examine PTCA versus STENT versus LIMA-LAD with respect to short- and intermediate-term outcomes., Methods and Results: This was an observational retrospective cohort study comparing in-hospital and intermediate-term outcomes and functional class among patients with isolated single-vessel LAD disease revascularization. Consecutive eligible patients were grouped according to their initial revascularization procedure and systematically followed up. A total of 704 patients qualified for the study: 469 in the PTCA group, 137 in the STENT group, and 98 in the LIMA-LAD group. Follow-up data were complete for 97% of patients and averaged 27+/-13 months. In-hospital mortality for the PTCA, STENT, and LIMA-LAD groups was 1.1%, 0%, and 0% (P=0.51), respectively. Median hospital stays after the procedure for the respective treatment groups were 1, 1, and 5 days (P<0.001), and occurrences of in-hospital myocardial infarction were 0.9%, 1.5%, and 1.0% (P=NS). Repeat revascularization procedures were performed in 30%, 24%, and 5% of the PTCA, STENT, and LIMA-LAD groups (P=<0. 001 for LIMA-LAD versus other groups, P=0.11 for PTCA versus STENT). Actuarial 2-year mortality was 3.9%, 2.6%, and 1% in the PTCA, STENT, and LIMA-LAD groups (P=0.33)., Conclusions: Revascularization for isolated LAD disease using PTCA, STENT, or LIMA-LAD results in low in-hospital adverse event rates and good long-term results. Repeat procedures are required less often after LIMA-LAD than after either PTCA or STENT. Long-term mortality was not statistically different, but the trend was for the lowest mortality with LIMA-LAD, a somewhat higher mortality with STENT, and the highest mortality with PTCA.

Context: Intercessory prayer (praying for others) has been a common response to sickness for millennia, but it has received little scientific attention. The positive findings of a previous controlled trial of intercessory prayer have yet to be replicated., Objective: To determine whether remote, intercessory prayer for hospitalized, cardiac patients will reduce overall adverse events and length of stay., Design: Randomized, controlled, double-blind, prospective, parallel-group trial., Setting: Private, university-associated hospital., Patients: Nine hundred ninety consecutive patients who were newly admitted to the coronary care unit (CCU)., Intervention: At the time of admission, patients were randomized to receive remote, intercessory prayer (prayer group) or not (usual care group). The first names of patients in the prayer group were given to a team of outside intercessors who prayed for them daily for 4 weeks. Patients were unaware that they were being prayed for, and the intercessors did not know and never met the patients., Main Outcome Measures: The medical course from CCU admission to hospital discharge was summarized in a CCU course score derived from blinded, retrospective chart review., Results: Compared with the usual care group (n = 524), the prayer group (n = 466) had lower mean +/- SEM weighted (6.35 +/- 0.26 vs 7.13 +/- 0.27; P=.04) and unweighted (2.7 +/- 0.1 vs 3.0 +/- 0.1; P=.04) CCU course scores. Lengths of CCU and hospital stays were not different., Conclusions: Remote, intercessory prayer was associated with lower CCU course scores. This result suggests that prayer may be an effective adjunct to standard medical care.

Approximately 80% of all patients with diabetes die of cardiovascular disease. The traditional management of type 2 diabetes has been ineffective in altering this dismal prognosis. Insulin resistance is the fundamental defect of type 2 diabetes. Insulin resistance often leads to hyperinsulinemia, which is associated with hypertension, atherogenic dyslipidemia, left ventricular hypertrophy, impaired fibrinolysis, visceral obesity, and sedentary lifestyle. Although all these conditions are associated with atherosclerosis and adverse cardiovascular events, the therapeutic efforts in patients with diabetes have focused predominantly on normalizing glucose levels. Improved insulin sensitivity through lifestyle modifications or pharmacologic therapy (troglitazone and metformin) will lower both insulin and glucose levels as well as diminish dyslipidemia and hypertension. In contrast, sulfonylurea agents lower glucose by increasing insulin levels and may increase the risk of cardiovascular events. Therapy including aspirin, lipid agents (for example, statins), angiotensin-converting enzyme inhibitors, beta-adrenergic blockers, postmenopausal estrogen replacement, and vitamin E should be considered for patients with type 2 diabetes. In most patients with diabetes who have multivessel coronary artery disease, coronary artery bypass grafting is superior to coronary angioplasty for improving long-term cardiovascular prognosis. This superiority is mediated in part by the use of a left internal mammary graft to the left anterior descending coronary artery. Urgent coronary angioplasty or thrombolytic therapy should be considered for all patients with diabetes who have acute myocardial infarction.

Objectives: The purpose of this study was to compare 3-year risk-adjusted survival in patients undergoing coronary artery bypass graft (CABG) surgery and percutaneous transluminal coronary angioplasty., Background: Coronary artery bypass graft surgery and angioplasty are two common treatments for coronary artery disease. For referral purposes, it is important to know the relative pattern of survival after hospital discharge for these procedures and to identify patient characteristics that are related to survival., Methods: New York's CABG surgery and angioplasty registries were used to identify New York patients undergoing CABG surgery and angioplasty from January 1, 1993 to December 31, 1995. Mortality within 3 years of undergoing the procedure (adjusted for patient severity of illness) and subsequent revascularization within 3 years were captured. Three-year mortality rates were adjusted using proportional hazards methods to account for baseline differences in patients' severity of illness., Results: Patients with one-vessel disease with the one vessel not involving the left anterior descending artery (LAD) or with less than 70% LAD stenosis had a statistically significantly longer adjusted 3-year survival with angioplasty (95.3%) than with CABG surgery (92.4%). Patients with proximal LAD stenosis of at least 70% had a statistically significantly longer adjusted 3-year survival with CABG surgery than with angioplasty regardless of the number of coronary vessels diseased. Also, patients with three-vessel disease had a statistically significantly longer adjusted 3-year survival with CABG surgery regardless of proximal LAD disease. Patients with other one-vessel or two-vessel disease had no treatment-related differences in survival., Conclusions: Treatment-related survival benefit at 3-years in patients with ischemic heart disease is predicted by the anatomic extent and specific site of the disease, as well as by the treatment chosen.

Aims: Some recent studies have reported-superior outcomes for diabetic patients following coronary bypass surgery compared with coronary angioplasty. However, the available data are conflicting, are based on relatively small numbers of diabetic patients, and have limited duration of follow-up. The aims of this study were to compare risk adjusted long-term survival in diabetic patients following first-time revascularization via either coronary bypass surgery or coronary angioplasty; and, to identify variables independently associated with mortality., Methods and Results: This was a two centre database project involving 15809 patients undergoing either coronary angioplasty or coronary bypass surgery as their initial revascularization procedure. Diabetes was present in 1938 (12%). Mean follow-up was 4.6+/-2.7 years for angioplasty and 6.6+/-4.3 years surgery diabetic patients. Multivariable time-related analyses in the hazard function domain for death were performed. Overall ten-year survival for pharmacologically treated diabetics was better after coronary bypass surgery (60%) than angioplasty (46%, <0.0001). However, the risk-adjusted survival advantage conferred by bypass surgery over angioplasty was strongest for patients receiving oral agents for diabetic control (75% vs 62%) and less impressive for diet (84% vs 81%) and insulin-treated diabetics (63% vs 64%). The major factors independently associated with worse outcome after angioplasty were incomplete revascularization, and the use of a sulfonylurea agent. The use of the left internal mammary graft improved survival in surgical patients., Conclusions: In general, diabetic patients had better long-term survival after bypass surgery than angioplasty. Incomplete revascularization and sulfonylurea therapy worsened outcome after angioplasty, and use of the left internal mammary improved outcome after bypass surgery.

Background: The purpose of this study was to evaluate outcomes after coronary bypass surgery versus coronary angioplasty in 525 patients with pharmacologically treated diabetes. Diabetic patients constitute a significant portion of patients considered for coronary revascularization. Some studies have shown no difference in long-term outcome when comparing revascularization mode. Recently, the Bypass Angioplasty Revascularization Investigation reported better survival with bypass surgery over angioplasty in treated diabetic patients. However, the above studies have been limited by small cohorts of diabetic patients., Methods and Results: By using a single-institution comprehensive database, a retrospective cohort design was used to study 525 consecutive pharmacologically treated diabetic patients who underwent coronary revascularization. Patients treated with surgery (n=246) were statistically similar when comparing age, gender, angina class, and ejection fraction to patients (n=279) treated with angioplasty. Follow-up was complete in 95% of bypass patients and 99% of angioplasty patients. Mean follow-up was 55.5 months. Complete revascularization was accomplished more often in the surgery group (79%) than in the angioplasty group (42%; P<.001). During a 6-year follow-up, repeat revascularization (8% versus 64%; P=.001), cardiac events (32% versus 41%; P=.04), and death (30% versus 37%; P=.08) occurred less in the bypass patients than the angioplasty patients. Multivariable analysis identified age >70 years, ejection fraction <40%, class IV angina, and incomplete revascularization, but not mode of revascularization, as correlates of late mortality., Conclusions: For most pharmacologically treated diabetic patients, freedom from death, myocardial infarction, and subsequent revascularization during long-term follow-up is superior with bypass surgery compared with angioplasty. This worse outcome was mediated in part by the frequent occurrence of incomplete revascularization with angioplasty.

Objective: To assess the relationship between each of 2 provider volume measures (annual hospital volume and annual cardiologist volume) for percutaneous transluminal coronary angioplasty (PTCA) and 2 outcomes of PTCA (in-hospital mortality and same-stay coronary artery bypass graft [CABG] surgery)., Design: Cohort study, using data from January 1, 1991, through December 31, 1994, from the Coronary Angioplasty Reporting System of the New York State Department of Health., Setting: Thirty-one hospitals in New York State in which PTCA was performed during 1991-1994., Patients: All 62670 patients discharged after undergoing PTCA in these hospitals during 1991-1994., Main Outcome Measures: Rates of in-hospital mortality and CABG surgery during the same stay as the PTCA., Results: The overall in-hospital mortality rate for patients undergoing PTCA in New York during 1991-1994 was 0.90%, and the same-stay CABG surgery rate was 3.43%. Patients undergoing PTCA in hospitals with annual PTCA volumes less than 600 experienced a significantly higher risk-adjusted in-hospital mortality rate of 0.96% (95% confidence interval [CI], 0.91%-1.01%) and risk-adjusted same-stay CABG surgery rate of 3.92% (95% CI, 3.76%-4.08%). Patients undergoing PTCA by cardiologists with annual PTCA volumes less than 75 had mortality rates of 1.03% (95% CI, 0.91%-1.17%) and same-stay CABG surgery rates of 3.93% (95% CI, 3.65%-4.24%); both of these rates were also significantly higher than the rates for all patients. Also, same-stay CABG surgery rates for patients undergoing PTCA in hospitals with annual volumes of 600 to 999 performed by cardiologists with annual volumes of 75 to 174 (2.99%; 95% CI, 2.69%-3.31 %) and 175 or more (2.84%; 95% CI, 2.57%-3.14%) were significantly lower than the overall statewide rate (3.43%)., Conclusions: In New York State, both hospital PTCA volume and cardiologist PTCA volume are significantly inversely related to in-hospital mortality rate and same-stay CABG surgery rate for patients undergoing PTCA.

Objectives: The purpose of this study was to assess the effects of estrogen replacement therapy on long-term outcome, including restenosis, myocardial infarction, stroke and death after a first percutaneous transluminal coronary angioplasty (PTCA) procedure, in postmenopausal women., Background: Observational and epidemiologic studies, basic laboratory research and clinical trials consistently suggest that estrogen replacement therapy is associated with beneficial cardiovascular effects in women. These cardioprotective actions may be particularly relevant to women with coronary artery disease, such as those who have undergone PTCA., Methods: This was a retrospective study that included 337 women who underwent elective PTCA between 1982 and 1994. The treatment group consisted of 137 consecutive women receiving long-term estrogen therapy at the time of elective PTCA and during follow-up. The control group comprised 200 women who were computer-matched with the estrogen group. The mean follow-up period was 65 +/- 35 months., Results: Actuarial survival was superior in the estrogen group; the 7-year survival rate was 93% for the estrogen group versus 75% for the control group (p = 0.001). The cardiovascular event rate (death, nonfatal myocardial infarction or nonfatal stroke) was significantly lower in the estrogen group at 7 years (12% vs. 35% in the control group, p = 0.001). The need for subsequent revascularization during follow-up was similar in the two groups. Multivariable analysis identified diabetes, estrogen therapy (adjusted risk ratio 0.38, 95% confidence interval 0.19 to 0.79) and left ventricular ejection fraction < 40% as independent correlates of cardiovascular death or myocardial infarction during follow-up., Conclusions: Estrogen replacement therapy was associated with an improved long-term outcome after PTCA in postmenopausal women.

Objectives: We attempted to determine the relative risks and benefits of percutaneous transluminal coronary angioplasty (PTCA) and repeat coronary artery bypass grafting (re-CABG) in patients with previous coronary bypass surgery (CABG)., Background: Due to an expanding population of patients with surgically treated coronary artery disease and the natural progression of atherosclerosis, an increasing number of patients with previous CABG require repeat revascularization procedures. Although there are randomized comparative data for CABG versus medical therapy and, more recently, versus PTCA, these studies have excluded patients with previous CABG., Methods: We retrospectively analyzed data from 632 patients with previous CABG who required either elective re-CABG (n = 164) or PTCA (n = 468) at a single center during 1987 through 1988. The PTCA and re-CABG groups were similar with respect to gender (83% vs. 85% male), age > 70 years (21% vs. 23%), mean left ventricular ejection fraction (46% vs. 48%), presence of class III or IV angina (70% vs. 63%) and three-vessel coronary artery disease (77% vs. 74%)., Results: Complete revascularization was achieved in 38% of patients with PTCA and 92% of those with re-CABG (p < 0.0001). The in-hospital complication rates were significantly lower in the PTCA group: death (0.3% vs. 7.3%, p < 0.0001) and Q wave myocardial infarction (MI) (0.9% vs. 6.1%, p < 0.0001). Actuarial survival was equivalent at 1 year (PTCA 95% vs. re-CABG 91%) and 6 years (PTCA 74% vs. re-CABG 73%) of follow-up (p = 0.32). Both procedures resulted in equivalent event-free survival (freedom from dealth or Q wave MI) and relief of angina; however, the need for repeat percutaneous or surgical revascularization, or both, by 6 years was significantly higher in the PTCA group (PTCA 64% vs. re-CABG 8%, p < 0.0001). Multivariate analysis identified age > 70 years, left ventricular ejection fraction < 40%, unstable angina, number of diseased vessels and diabetes mellitus as independent correlates of mortality for the entire group., Conclusions: In this nonrandomized series of patients with previous CABG requiring revascularization, an initial stategy of either PTCA or re-CABG resulted in equivalent overall survival, event-free survival and relief of angina. PTCA offers lower procedural morbidity and mortality risks, although it is associated with less complete revascularization and a greater need for subsequent revascularization procedures.

Combination lovastatin and probucol reduced total cholesterol (27%) and low-density lipoprotein levels (30%), but did not prevent restenosis or clinical events during the first 6 months after percutaneous transluminal coronary angioplasty.

Objective: To present information about risk factor clustering and the oxidation hypothesis of atherosclerosis and attempt to synthesize these facts into a clinically relevant approach to patients with or at risk for coronary artery disease (CAD)., Material and Methods: The total cholesterol level is a relatively weak marker for the risk of CAD. The levels of both high-density lipoprotein (HDL) cholesterol and remnants of triglyceride-rich lipoproteins and the inherent susceptibility of the low-density lipoprotein (LDL) particles to oxidative modification may be as important as the total or LDL cholesterol levels. LDL cholesterol must undergo oxidative modification by means of oxygen free radical processes before it becomes atherogenic. Patients with high levels of oxidative stress include those with risk factor clustering or insulin resistance (or both). Such patients are characterized by hypertension, truncal obesity, hypertriglyceridemia, depressed HDL cholesterol levels, and increased insulin levels. They also have increased levels of triglyceride-rich remnant lipoproteins and LDL particles that are characterized by their small dense nature and pronounced predisposition to oxidative modification., Results: Biologic antioxidants seem to be promising therapy for the prevention of atherogenesis. Although long-term prospective data are not yet available, vitamin E has been shown to be effective in both animal and human models in preventing LDL oxidation, and it may have a role in the prevention of CAD. A healthy diet of fresh fruits, vegetables, and whole grains is beneficial because it improves the lipid levels and provides high levels of natural antioxidants. The atherogenic potential of hydrogenated polyunsaturated fats is approximately equivalent to that of saturated fats. Monounsaturated fat is inherently resistant to oxidation and may be protective against CAD. Niacin may be effective in patients with clustered risk factors. It has been found to convert the easily oxidized small dense LDL pattern to the large buoyant oxidation-resistant particles. Hydroxymethylglutaryl-coenzyme A reductase inhibitors are well tolerated and highly effective in decreasing LDL cholesterol, but they are expensive. Estrogen has multiple potentially beneficial effects relative to cardiovascular disease., Conclusion: Persons with or at high risk for CAD should be identified early and aggressively treated with a program that involves lifestyle changes, alterations in dietary intake, and pharmacologic therapy.

Objectives: This study compared the relative risks and benefits of coronary angioplasty and coronary artery bypass graft surgery in patients > 70 years old., Background: Few objective, comparative data exist to guide the clinician in the decision to use bypass surgery or angioplasty in elderly patients., Methods: The study was a case-control, retrospective analysis of 195 consecutive patients who underwent bypass surgery in 1987 and 1988 and were compared with a concurrent cohort of 195 coronary angioplasty-treated patients. The groups were matched for left ventricular function, age and gender mix., Results: The in-hospital morbidity and mortality rates were significantly lower in the coronary angioplasty-treated patients. Mean postprocedural hospital stay was 4.8 and 14.3 days for angioplasty and surgical group patients, respectively (p < 0.001). In-hospital death occurred in 2% of angioplasty-treated patients compared with 9% of surgically treated patients (p = 0.007). Serious in-hospital stroke occurred in no patient in the angioplasty group and in 5% of patients in the surgical group (p < 0.0001). Q wave infarction occurred in 1% of angioplasty-treated patients and 6% of bypass-treated patients (p = 0.01). The 5-year actuarial survival rate was similar in the two groups: 63% in the angioplasty group, 65% in the bypass group (p = NS). However, surgical group patients experienced less recurrent angina, required fewer repeat revascularization procedures and had fewer Q wave infarctions during follow-up compared with angioplasty group patients., Conclusions: When performed in patients > 70 years old, angioplasty and coronary bypass surgery result in similar long-term survival rates but otherwise distinctly different clinical courses.

Background: Prior studies based on autopsy data suggest that infarction of more than 40% of the left ventricle necessitates cardiogenic shock and death., Methods and Results: Technetium-99m Sestamibi tomography was used prospectively to measure infarct size at discharge in 166 patients with acute myocardial infarction. Patients with previous myocardial infarction or revascularization were excluded from the trial. Sixteen patients were identified with final infarct sizes > 40% of the left ventricle despite acute reperfusion therapy. These 16 patients (13 men) had a mean age of 63 +/- 10 years; 44% had a previous history of angina. Ten patients had emergent coronary angioplasty only (mean time to percutaneous transluminal coronary angioplasty [PTCA], 6.0 +/- 3.0 hours); 6 had thrombolysis (mean time to tissue plasminogen activator, 4.0 +/- 1.5 hours), of which 2 had rescue PTCA (5 and 3 hours from onset of pain). Of 15 patients who had angiograms after therapy, 15 had open infarct-related arteries. The left anterior descending artery was the infarct-related artery in 14 (9 proximal and 5 distal lesions). Half the patients had only single-vessel disease. Infarct size measured 50 +/- 7% of the left ventricle (range, 42% to 68%). Ejection fraction by radionuclide angiogram was 0.33 +/- 0.09 and 0.38 +/- 0.07 at discharge and 6 weeks, respectively. Hospital complications included shock (1 patient), pulmonary edema (2), angina (3), symptomatic nonsustained ventricular tachycardia (1), transient complete heart block (2), and transient bifascicular block (1). At follow-up (13 +/- 9 months), the patient with shock had died, but the remaining 15 patients were asymptomatic (1 had late PTCA for angina)., Conclusions: In the interventional and thrombolytic era, patients with large residual myocardial infarctions can survive without heart failure.

Patients with multivessel coronary artery disease and left ventricular dysfunction represent a high-risk subgroup in whom coronary artery bypass grafting has been shown to improve survival compared with that of medically treated patients. The comparative benefits and risks of coronary angioplasty and bypass surgery in this subgroup of patients are unclear. This study retrospectively analyzes 100 consecutive patients treated with bypass surgery compared with a matched, concurrent cohort of 100 treated with multivessel angioplasty. Early results favored angioplasty; a hospital stay of 12.8 days was noted in the bypass group compared with 4.3 days in the angioplasty group (p < 0.001). In-hospital mortality rates were similar in the bypass (5%) and angioplasty (3%) groups (p = NS). Stroke was observed significantly more often in the bypass group (7 vs 0%). However, late follow-up favored bypass patients; repeat revascularization procedures and late myocardial infarction occurred more frequently during follow-up in the angioplasty group. During 5-year follow-up, superior relief from disabling angina (99 vs 89%; p = 0.01) and a trend toward improved survival (76 vs 67%; p = 0.09) were observed in the bypass group as compared with the angioplasty group. Multivariate correlates of late mortality included age and incomplete revascularization, but not mode of revascularization. Thus, in patients with multivessel coronary artery disease and left ventricular dysfunction, early results favor angioplasty, whereas late follow-up favors bypass surgery. However, late survival was similar in both groups of patients who were completely revascularized.

Colchicine, an antimitogenic agent, has shown promise in preventing restenosis after coronary angioplasty in experimental animal models. A prospective trial was conducted involving 197 patients randomized in a 2:1 fashion to treatment with oral colchicine, 0.6 mg twice daily (130 patients), or placebo (67 patients) for 6 months after elective coronary angioplasty. Treatment in all patients began between 12 h before angioplasty and 24 h after angioplasty. Compliance monitoring revealed that 96% of all prescribed pills were ingested. Demographic characteristics were similar in colchicine- and placebo-treated groups. A mean of 2.7 lesions/patient were dilated. Side effects resulted in a 6.9% dropout rate in the colchicine-treated patients. Complete quantitative angiographic follow-up was obtained in 145 patients (74%) with 393 dilated lesions. Quantitative angiographic measurements were obtained in two orthogonal views at baseline before angioplasty and immediately and at 6 months after angioplasty. The quantitative mean lumen diameter stenosis before angioplasty was 67% both in the 152 lesions in the placebo-treated group and in the 241 lesions in the colchicine-treated group; this value was reduced to 24% immediately after angioplasty in the lesions in both treatment groups. At the 6-month angiogram, lesions had restenosed to 47% lumen diameter narrowing in the placebo-treated group compared with 46% in the colchicine-treated group (p = NS). Forty-one percent of colchicine-treated patients developed restenosis in at least one lesion compared with 45% of the placebo-treated group (p = NS). In conclusion, colchicine was ineffective for preventing restenosis after coronary angioplasty.

To assess the changes in myocardial function following direct coronary angioplasty, we evaluated 323 consecutive patients undergoing coronary angioplasty without antecedent thrombolytic therapy for acute myocardial infarction. Left ventricular function was evaluated using contrast ventriculography immediately preangioplasty and at the time of predismissal follow-up angiography (a mean of 7 days after infarction). The global ejection fraction increased from 52.6% to 58.9% (p less than 0.0005). Multivariate correlates of improved global left ventricular function included baseline ejection fraction less than or equal to 45%, and a patent infarct vessel at the time of predischarge follow-up angiography. Systolic function in the infarct zone improved by a mean of 30%. Logistic regression analysis identified sustained infarct vessel patency and anterior myocardial infarction as multivariate correlates of improved regional function in the infarct zone. In patients presenting with baseline ejection fractions less than or equal to 40%, the mean ejection fraction increased from 28% to 42%. Long-term survival was compromised in patients with global ejection fractions of less than or equal to 40% at the time of dismissal. Thus significant improvement in left ventricular function can be expected in the majority of patients undergoing direct infarct angioplasty. The myocardial salvage appears to be most significant in patients suffering large infarctions, and in those with sustained infarct vessel patency.

The risks and long-term outcome after 845 elective percutaneous transluminal coronary angioplasties (PTCA) in patients with left ventricular (LV) dysfunction (ejection fraction less than or equal to 40%) were examined. Procedural results were compared with 8,117 consecutive procedures in patients with ejection fractions greater than 40%. The patients with LV dysfunction were older (63 vs 60 years, p less than 0.01), had a greater incidence of prior myocardial infarction (84 vs 45%, p less than 0.001), prior bypass surgery (39 vs 21%, p less than 0.001), 3-vessel disease (62 vs 33%, p less than 0.001), and class IV angina (48 vs 41%, p less than 0.01) than the control group. Angiographic success was lower (93 vs 95%, p less than 0.01), and overall procedural mortality was increased ( 4 vs 1%, p less than 0.001) in the study group. Emergency surgery rates were identical (2%). No significant difference was found in rates of nonfatal Q-wave myocardial infarction (2 vs 1%). At mean follow-up of 33.5 months, 15% of the patients with LV dysfunction required late bypass surgery, 27% underwent repeat PTCA, and 59% were angina free. Actuarial survival at 1 and 4 years was 87 and 69%, respectively. Cox regression analysis identified 3-vessel disease, age greater than or equal to 70 years, class IV angina and incomplete revascularization as correlates of long-term mortality. These data suggest that PTCA may be an effective treatment for coronary artery disease in patients with LV dysfunction.

If coronary angioplasty can be safely performed at the time of the initial diagnostic catheterization, it may result in shorter hospitalization stays and lower overall costs. Combined coronary angiography and angioplasty was performed electively on 733 patients between January 1, 1984, and September 1, 1988. These patients were divided into three major subgroups based upon their indications for angioplasty: 444 (61%) procedures were performed for restenosis; 190 (26%) procedures were performed in patients for unstable angina; and 99 (13%) procedures were performed in patients without unstable angina or previous angioplasty. A subset of 219 patients from this study who underwent elective combined coronary angiography and angioplasty during 1986 were compared with a matched population of 191 patients from the angiography and angioplasty as separate procedures). The success and complication rates were similar for both of these groups. Patients who underwent the combined procedure were hospitalized for a mean of 4.6 days with average total charges of $11,128, compared with 8.0 days and $13,160 for patients undergoing separate procedures (p less than 0.001). Significant savings were also realized with respect to total contrast dose, fluoroscopic time, and total procedural time. Thus in informed patients with suitable coronary anatomy, the strategy of combined angiography and angioplasty may present an opportunity for decreasing hospitalization stay, reducing total charges for revascularization, and reducing radiation exposure without compromising the safety or effectiveness of the procedure.

A randomized, placebo-controlled, double-blinded trial was performed to evaluate the usefulness of empiric therapy with a calcium antagonist in patients who undergo coronary angioplasty. A total of 201 patients were randomized to placebo or to high-dose diltiazem (mean dose, 329 mg/day). Treatment began 24 hours before angioplasty. Restenosis was assessed by percent area stenosis as determined by quantitative angiographic techniques before, immediately and 1 year after angioplasty. All patients also received aspirin and dipyridamole before angioplasty. Heparin and verapamil were administered intravenously during the procedure. The 2 groups were similar with respect to age, extent of coronary artery disease, smoking history, and baseline lipid levels. Procedural complications, including death (1 vs 1), Q-wave infarction (0 vs 3), acute occlusion (5 vs 5) and focal spasm (0 vs 0), were not significantly different in the diltiazem and placebo patients, respectively. Freedom from all acute complications was noted in 85% of patients in both groups. One-year angiographic follow-up was obtained in 60% of patients. Restenosis rates were similar: 36% in the diltiazem group and 32% in the placebo group (p = 0.30). The incidence of late cardiac events (death, Q-wave myocardial infarction, recurrent angina or coronary bypass graft surgery) was similar in the 2 groups. Thus, diltiazem did not influence the overall restenosis rate or prevent late events after coronary angioplasty.

During a 6-year period ending December, 1976, 385 female patients underwent coronary artery bypass at the Mid-America Heart Institute. This group constituted 14.6% of the total experience. The operative (thirty day) mortality was 1.3%, which is not significantly greater than that experienced by male patients operated on concurrently. A total follow-up of 2,015 patient-years was obtained. The incidence of nonfatal acute myocardial infarction was 2.0 per 100 patient-years of follow-up, and the incidence of repeat coronary artery bypass was 0.8 per 100 patient-years. The actuarial survival was 90% at 5 years and 75.3% at 10 years. Of the 46 deaths (early or late), 58.7% were cardiac in nature. Although the absolute survival of women is as good as that observed in men, the female patients did not achieve the expected survival pattern of a matched (for age and sex) general population as is observed in our male patients undergoing coronary artery bypass. These results obtained with coronary artery bypass justify the use of similar criteria for the application of this therapy in men and women.

Eight men, 45 to 50 years of age, with mild stable angina pectoris, participated in a graduated exercise program. Coronary arteriography, left ventriculography, left ventricular hemodynamics at rest and during supine leg exercise, treadmill testing with electrocardiographic monitoring, and measurement of oxygen uptake were obtained before and 1 year after the exercise training program. No change was noted in the arteriographic appearance of coronary artery lesions or of collateral circulation. Left ventricular performance, assessed by qualitative left ventriculography and the hemodynamic response of the left ventricle to supine leg exercise, was unchanged after the training program. Oxygen consumption for a given repetitive work load during treadmill exercise decreased. Two patients with a pretraining exercise ECG positive for ischemia reverted to a normal response after the exercise program. All had a decrease in angina, an increase in self-esteem, and a more positive attitude toward their work and their disability.

Direct coronary angioplasty without antecedent thrombolytic therapy was performed in 500 consecutive patients with acute myocardial infarction. Anterior and inferior infarctions were noted in 217 and 283 patients, respectively. Two hundred fifteen patients (43%) had 1-vessel disease, 85 patients (17%) were greater than 70 years of age and 39 (8%) presented in cardiogenic shock. Successful angioplasty of the infarct vessel was achieved in 94% of patients. The overall in-hospital mortality was 7.2%. Cardiogenic shock, 3-vessel disease and failed angioplasty were the 3 strongest multivariate correlates of early mortality. Reocclusion of the infarct-vessel was noted in 47 (15%) of the 307 patients with angiographic follow-up before hospital discharge. Significant bleeding complications occurred in only 3% of patients; stroke or myocardial rupture was not seen. The global ejection fraction increased from 53% on the preangioplasty ventriculograms to 59% at 1 week (p less than 0.001). Significant regional wall motion improvement in the infarct segments was noted in 53% of patients. Global ejection fraction improved most dramatically in patients presenting with baseline ejection fractions less than or equal to 45% (increasing from 36 to 50%). The 1- and 5-year survival rates after hospital discharge were 95 and 84%, respectively. The 1-year reinfarction rate was 3%. Thus, direct coronary angioplasty was highly effective in reestablishing infarct-vessel patency and salvaging ischemic myocardium, resulting in low in-hospital and long-term mortality.

During a nine year period, 36 patients have been treated at the Mid-America Heart Institute for postinfarctional rupture of the interventricular septum. Twenty-two (61%) of the patients were male and the average age was 68.9 years. Coronary angiography revealed that 48% of the patients had single vessel coronary artery disease. Eight patients, under medical treatment, stabilized with congestive heart failure. One of these patients was operated upon early and six patients initially managed medically underwent delayed operation 1-6 months after septal rupture without operative mortality. Twenty-eight patients presented with or acutely developed the low cardiac output syndrome following septal rupture. None of eight such patients managed by medical treatment alone survived. The other twenty patients underwent emergency operation within seven days of occurrence of the ventricular septal rupture with seven operative deaths. In the entire surgical group, there were six late deaths and fourteen patients are currently surviving five months to six years and seven months postoperatively. It is concluded that patients who develop postinfarctional ventricular septal rupture and resultant low cardiac output syndrome should undergo prompt diagnostic studies and emergency surgical therapy. Those patients who stabilize with congestive heart failure are initially best managed medically and should undergo delayed surgical repair.

Successful percutaneous transluminal coronary angioplasty (PTCA) was performed during evolving acute myocardial infarction (AMI) in 41 patients. Catheterization was performed within 1 hour of presentation, from 1 to 12 hours (mean 3.3) following symptom onset. In 17 of 29 patients with a totally occluded coronary artery, successful thrombolytic therapy was followed by PTCA of a residual high-grade atheromatous stenosis. Successful PTCA without prior thrombolytic therapy was employed in 11 of 12 subtotal coronary stenoses producing acute infarction syndromes and in two patients having critical coronary stenoses not immediately responsible for AMI. Three patients experienced early in-hospital reocclusion with reinfarction. One death occurred in a patient presenting with cardiogenic shock. All remaining patients had prompt pain relief, subsequent stable clinical courses, and no clinical or late angiographic evidence of coronary reocclusion. Dramatic improvement of regional and global left ventricular function was evident in 22 of 27 patients undergoing late left ventricular angiography. At follow-up, 94% of patients remained free of angina although three required repeat dilatation of recurrent stenoses. We concluded that PTCA may be performed with or without thrombolytic therapy in selected patients with AMI and may reduce the likelihood of late reocclusion following successful thrombolytic therapy.