Integrating baseline health status data collection into the process of care.

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.

Short- and long-term mortality for patients undergoing primary angioplasty for acute myocardial infarction.

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.

A comparison of short- and long-term outcomes for balloon angioplasty and coronary stent placement.

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.

Isolated left anterior descending coronary artery disease: percutaneous transluminal coronary angioplasty versus stenting versus left internal mammary artery bypass grafting.

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.

A randomized, controlled trial of the effects of remote, intercessory prayer on outcomes in patients admitted to the coronary care unit.

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.

Improving the adverse cardiovascular prognosis of type 2 diabetes.

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.

A comparison of three-year survival after coronary artery bypass graft surgery and percutaneous transluminal coronary angioplasty.

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.

The optimal mode of coronary revascularization for diabetics. A risk-adjusted long-term study comparing coronary angioplasty and coronary bypass surgery.

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.

Bypass surgery versus coronary angioplasty for revascularization of treated diabetic patients.

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.

Coronary angioplasty volume-outcome relationships for hospitals and cardiologists.

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.

Estrogen replacement therapy after coronary angioplasty in women.

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.

Coronary angioplasty versus repeat coronary artery bypass grafting for patients with previous bypass surgery.

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.

Lovastatin plus probucol for prevention of restenosis after percutaneous transluminal coronary angioplasty.

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.

Insights into the pathogenesis and prevention of coronary artery disease.

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.

Coronary angioplasty versus bypass surgery in patients > 70 years old matched for ventricular function.

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.