Michael J. Hearne

Survival of patients with diabetes and multivessel coronary artery disease after surgical or percutaneous coronary revascularization: results of a large regional prospective study

OBJECTIVES We sought to assess survival among patients with diabetes and multivessel coronary artery disease (MVD) after percutaneous coronary intervention (PCI) and after coronary artery bypass grafting surgery (CABG). BACKGROUND The Bypass Angioplasty Revascularization Investigation (BARI) demonstrated that diabetics with MVD survive longer after initial CABG than after initial PCI. Other randomized trials or observational databases have not conclusively reproduced this result. METHODS A large, regional database was linked to the National Death Index to assess five-year mortality. Of 7,159 consecutive patients with diabetes who underwent coronary revascularization in northern New England during 1992 to 1996, 2,766 (38.6%) were similar to those randomized in the BARI trial. Percutaneous coronary intervention was the initial revascularization strategy in 736 patients and CABG in 2,030. Cox proportional hazards regression was used to calculate risk-adjusted hazard ratios (HR) and 95% confidence intervals (CI 95%). RESULTS Patients who underwent PCI were younger, had higher ejection fractions and less extensive coronary disease. After adjusting for differences in baseline clinical characteristics, patients with diabetes treated with PCI had significantly greater mortality relative to those undergoing CABG (HR = 1.49; CI 95%: 1.02 to 2.17; p = 0.037). Mortality risk tended to increase more among 1,251 patients with 3VD (HR = 2.02; CI 95%: 1.04 to 3.91; p = 0.038) than among 1,515 patients with 2VD (HR = 1.33; CI 95%: 0.84 to 2.1; p = 0.21). CONCLUSIONS In this analysis of a large regional contemporary database of patients with diabetes selected to be similar to those enrolled in the BARI trial, five-year mortality was significantly increased after initial PCI. This supports the BARI conclusion on initial revascularization of patients with diabetes and MVD.

Predicting vascular complications in percutaneous coronary interventions

OBJECTIVES Using a large, current, regional registry of percutaneous coronary interventions (PCI), we identified risk factors for postprocedure vascular complications and developed a scoring system to estimate individual patient risk. BACKGROUND A vascular complication (access-site injury requiring treatment or bleeding requiring transfusion) is a potentially avoidable outcome of PCI. METHODS Data were collected on 18,137 consecutive patients undergoing PCI in northern New England from January 1997 to December 1999. Multivariate regression was used to identify characteristics associated with vascular complications and to develop a scoring system to predict risk. RESULTS The rate of vascular complication was 2.98% (541 cases). Variables associated with increased risk in the multivariate analysis included age >or=70, odds ratio (OR) 2.7, female sex (OR 2.4), body surface area <1.6 m(2) (OR 1.9), history of congestive heart failure (OR 1.4), chronic obstructive pulmonary disease (OR 1.5), renal failure (OR 1.9), lower extremity vascular disease (OR 1.4), bleeding disorder (OR 1.68), emergent priority (OR 2.3), myocardial infarction (OR 1.7), shock (1.86), >or=1 type B2 (OR 1.32) or type C (OR 1.7) lesions, 3-vessel PCI (OR 1.5), use of thienopyridines (OR 1.4) or use of glycoprotein IIb/IIIa receptor inhibitors (OR 1.9). The model performed well in tests for significance, discrimination, and calibration. The scoring system captured 75% of actual vascular complications in its highest quintiles of predicted risk. CONCLUSION Predicting the risk of post-PCI vascular complications is feasible. This information may be useful for clinical decision-making and institutional efforts at quality improvement.

Comparing long-term survival of patients with multivessel coronary disease after CABG or PCI: Analysis of BARI-like patients in Northern New England

Background—Randomized trials comparing coronary artery bypass graft surgery (CABG) with percutaneous coronary interventions (PCIs) for patients with multivessel coronary disease (MVD) report similar long-term survival for CABG and PCI. These studies used a highly selected population of patients and providers, and their results may not be generalizable to actual care. Our goal in this study was to compare long-term survival of MVD patients treated with CABG vs PCI in contemporary practice. Methods and Results—From our northern New England registries of consecutive coronary revascularizations, we identified 10 198 CABG and 4295 PCI patients with MVD who may have been eligible for either procedure between 1994 and 2001. Vital status was obtained by linkage to the National Death Index. Proportional-hazards regression was used to calculate hazard ratios (HRs) for survival in CABG vs PCI patients after adjustment for comorbidities and disease characteristics. CABG patients were older; had more comorbidities, more 3-vessel disease, and lower ejection fractions; and were more completely revascularized. Adjusted long-term survival for patients with 3-vessel disease was better after CABG than PCI (HR, 0.60; P<0.01) but not for patients with 2-vessel disease (HR, 0.98; P=0.77). The survival advantage of CABG for 3-vessel disease patients was present in all patient populations, including women, diabetics, and the elderly and in the era of high stent utilization. Conclusions—In contemporary practice, survival for patients with 3-vessel coronary disease is better after CABG than PCI, an observation that patients and physicians should carefully consider when deciding on a revascularization strategy.

Multivariate prediction of in-hospital mortality after percutaneous coronary interventions in 1994-1996

OBJECTIVES Using recent data, we sought to identify risk factors associated with in-hospital mortality among patients undergoing percutaneous coronary interventions. BACKGROUND The ability to accurately predict the risk of an adverse outcome is important in clinical decision making and for risk adjustment when assessing quality of care. Most clinical prediction rules for percutaneous coronary intervention (PCI) were developed using data collected before the broader use of new interventional devices. METHODS Data were collected on 15,331 consecutive hospital admissions by six clinical centers. Logistic regression analysis was used to predict the risk of in-hospital mortality. RESULTS Variables associated with an increased risk of in-hospital mortality included older age, congestive heart failure, peripheral or cerebrovascular disease, increased creatinine levels, lowered ejection fraction, treatment of cardiogenic shock, treatment of an acute myocardial infarction, urgent priority, emergent priority, preprocedure insertion of an intraaortic balloon pump and PCI of a type C lesion. The receiver operating characteristic area for the predicted probability of death was 0.88, indicating a good ability to discriminate. The rule was well calibrated, predicting accurately at all levels of risk. Bootstrapping demonstrated that the estimate was stable and performed well among different patient subsets. CONCLUSIONS In the current era of interventional cardiology, accurate calculation of the risk of in-hospital mortality after a percutaneous coronary intervention is feasible and may be useful for patient counseling and for quality improvement purposes.

Serious renal dysfunction after percutaneous coronary interventions can be predicted

BACKGROUND A prediction rule for determining the post-percutaneous coronary intervention (PCI) risk of developing contrast-induced nephropathy (> or = 25% or > or = 0.5 mg/dL increase in creatinine) has been reported. However, little work has been done on predicting pre-PCI patient-specific risk for developing more serious renal dysfunction (SRD; new dialysis, > or = 2.0 mg/dL absolute increase in creatinine, or a > or = 50% increase in creatinine). We hypothesized that preprocedural patient characteristics could be used to predict the risk of post-PCI SRD. METHODS Data were prospectively collected on a consecutive series of 11141 patients undergoing PCI without dialysis in northern New England from 2003 to 2005. Multivariate logistic regression model was used to identify the combination of patient characteristics most predictive of developing post-PCI SRD. The ability of the model to discriminate was quantified using a bootstrap validated C-Index (area under the receiver operating characteristic [ROC] curve). Its calibration was tested with a Hosmer-Lemeshow statistic. The model was validated on PCI procedures in 2006. RESULTS Serious renal dysfunction occurred in 0.74% of patients (83/11141) with an associated inhospital mortality of 19.3% versus 0.9% in those without SRD. The model discriminated well between patients who did and did not develop SRD after PCI (ROC 0.87, 95% CI 0.82-0.91). Preprocedural creatinine (37%), congestive heart failure (24%), and diabetes (15%) accounted for 76% of the predictive ability of the model. The other factors contributed 24%: urgent and emergent priority (10%), preprocedural intra-aortic balloon pump use (8%), age > or = 80 years (5%), and female sex (1%). Validation of the model was successful with ROC: 0.84 (95% CI 0.80-0.89). CONCLUSIONS Although infrequent, the occurrence of SRD after PCI is associated with a very high inhospital mortality. We developed and validated a robust clinical prediction rule to determine which patients are at high risk for SRD. Use of this model may help physicians perform targeted interventions to reduce this risk.

Percutaneous transluminal coronary angioplasty in the elderly: Epidemiology, clinical risk factors, and in-hospital outcomes☆☆☆★

Objectives To explore the relation between older age and clinical presentation, procedural success, and in-hospital outcomes among a large unselected population undergoing percutaneous transluminal coronary angioplasty (PTCA). Background Although more elderly patients are receiving PTCA, studies of post-PTCA outcomes among the elderly have been limited by small numbers and exclusive selection criteria. Methods Data were collected as a part of a prospective registry of all percutaneous coronary interventions performed in Maine, New Hampshire, and from 1 institution in Massachusetts between October 1989 and December 1993. Comparisons across 4 age groups, (<60, 60 to 69, 70 to 79, and 80 years and above) were performed using chi-square tests, the Mantel-Haenzsel test for trend, and logistic regression. Results Twelve thousand one hundred seventy-two hospitalizations for PTCA were performed with 507 of them (4%) in persons at least 80 years old. Octogenarians were more likely to be women, have multivessel disease, high-grade stenoses, and complex lesions but were less likely to have hypercholesterolemia, a history of smoking, or have undergone a previous PTCA. In the elderly, PTCAs were more often performed urgently and for unstable syndromes compared with younger age groups. Advancing age is strongly associated with in-hospital death, and among the oldest old with an increased risk of postprocedural myocardial infarction. Despite differing presentation and procedural priority, angiographic success and subsequent bypass surgery did not vary by age. Conclusions With the increasing age of the population at large as well as that segment at risk for cardiac revascularization, information about age-associated risks of the procedure, especially the substantially higher risk of death in octogenarians, will be critical for both physicians and patients considering PTCA. (Am Heart J 1999;137:639-45.)

The relationship between operator volume and outcomes after percutaneous coronary interventions in high volume hospitals in 1994–1996: The northern New England experience

OBJECTIVES The purpose of this study was to examine the relationship between annual operator volume and outcomes of percutaneous coronary interventions (PCIs) using contemporaneous data. BACKGROUND The 1997 American College of Cardiology (ACC)/American Heart Association task force based their recommendation that interventionists perform > or = 75 procedures per year to maintain competency in PCI on data collected largely in the early 1990s. The practice of interventional cardiology has since changed with the availability of new devices and drugs. METHODS Data were collected from 1994 through 1996 on 15,080 PCIs performed during 14,498 hospitalizations by 47 interventional cardiologists practicing at the five high volume (>600 procedures per hospital per year) hospitals in northern New England and one Massachusetts-based institution that support these procedures. Operators were categorized into terciles based on their annualized volume of procedures. Multivariate regression analysis was used to control for case-mix. In-hospital outcomes included death, emergency coronary artery bypass graft surgery (eCABG), non-emergency CABG (non-eCABG), myocardial infarction (MI), death and clinical success (> or = 1 attempted lesion dilated to < 50% residual stenosis and no death, CABG or MI). RESULTS Average annual procedure rates varied across terciles from low = 68, middle = 115 and high = 209. After adjusting for case-mix, clinical success rates were comparable across terciles (low, middle and high terciles: 90.9%, 88.8% and 90.7%, Ptrend = 0.237), as were all the adverse outcomes including death (low-risk patients = 0.45%, 0.41%, 0.71%, Ptrend = 0.086; high-risk patients = 5.68%, 5.99%, 7.23%, Ptrend = 0.324), eCABG (1.74%, 2.05%, 1.75%, Ptrend = 0.733) and MI (2.57%, 1.90%, 1.86%, Ptrend = 0.065). CONCLUSIONS Using current data, there is no significant relationship between operator volumes averaging > or = 68 per year and outcomes at high volume hospitals. Future efforts should be directed at determining the generalizability of these results.

Operator Volume and Outcomes in 12,988 Percutaneous Coronary Interventions

OBJECTIVES We sought to determine whether there is a relation between operator volume and outcomes for percutaneous coronary interventions (PCIs). BACKGROUND A 1993 American College of Cardiology/American Heart Association task force stated that cardiologists should perform > or = 75 procedures/year to maintain competency in PCIs; however, there were limited data available to support this statement. METHODS Data were collected from 1990 through 1993 on 12,988 PCIs (12,118 consecutive hospital admissions) performed by 31 cardiologists at two hospitals in New Hampshire and two in Maine and one hospital in Massachusetts supporting these procedures. Operators were categorized into terciles based on annualized volume of procedures. Univariate and multivariate regression analyses were used to control for case-mix. Successful outcomes included angiographic success (all lesions attempted dilated to < 50% residual stenosis) and clinical success (at least one lesion dilated to < 50% residual stenosis and no adverse outcomes). In-hospital adverse outcomes included coronary artery bypass graft surgery (CABG), myocardial infarction (MI) and death. RESULTS After adjustment for case-mix, higher angiographic (low, middle and high terciles: 84.7%, 86.1% and 90.3%, p-trend 0.006) and clinical success rates (85.8%, 88.0% and 90.7%, p-trend 0.025), with fewer referrals to CABG (4.54%, 3.75% and 2.49%, p-trend <0.001), were seen as operator volume increased. There was a trend toward higher MI rates for high volume operators (2.00%, 1.98% and 2.57%, p-trend 0.06); all terciles had similar in-hospital mortality rates (1.09%, 0.96% and 1.05%, p-trend 0.8). CONCLUSIONS There is a significant relation between operator volume and outcomes in PCIs. Efforts should be directed toward understanding why high volume operators are more successful and encounter fewer adverse outcomes.Objectives. We sought to determine whether there is a relation between operator volume and outcomes for percutaneous coronary interventions (PCIs). Background. A 1993 American College of Cardiology/American Heart Association task force stated that cardiologists should perform ≥75 procedures/year to maintain competency in PCIs; however, there were limited data available to support this statement. Methods. Data were collected from 1990 through 1993 on 12,988 PCIs (12,118 consecutive hospital admissions) performed by 31 cardiologists at two hospitals in New Hampshire and two in Maine and one hospital in Massachusetts supporting these procedures. Operators were categorized into terciles based on annualized volume of procedures. Univariate and multivariate regression analyses were used to control for case-mix. Successful outcomes included angiographic success (all lesions attempted dilated to <50% residual stenosis) and clinical success (at least one lesion dilated to <50% residual stenosis and no adverse outcomes). In-hospital adverse outcomes included coronary artery bypass graft surgery (CABG), myocardial infarction (MI) and death. Results. After adjustment for case-mix, higher angiographic (low, middle and high terciles: 84.7%, 86.1% and 90.3%, p-trend 0.006) and clinical success rates (85.8%, 88.0% and 90.7%, p-trend 0.025), with fewer referrals to CABG (4.54%, 3.75% and 2.49%, p-trend <0.001), were seen as operator volume increased. There was a trend toward higher MI rates for high volume operators (2.00%, 1.98% and 2.57%, p-trend 0.06); all terciles had similar in-hospital mortality rates (1.09%, 0.96% and 1.05%, p-trend 0.8). Conclusions. There is a significant relation between operator volume and outcomes in PCIs. Efforts should be directed toward understanding why high volume operators are more successful and encounter fewer adverse outcomes.

Changing outcomes in percutaneous coronary interventions: A study of 34,752 procedures in Northern New England, 1990 to 1997

OBJECTIVES We sought to evaluate the changing outcomes of percutaneous coronary interventions (PCIs) in recent years. BACKGROUND The field of interventional cardiology has seen considerable growth in recent years, both in the number of patients undergoing procedures and in the development of new technology. In view of recent changes, we evaluated the experience of a large, regional registry of PCIs and outcomes over time. METHODS Data were collected from 1990 to 1997 on 34,752 consecutive PCIs performed at all hospitals in Maine (two), New Hampshire (two) and Vermont (one) supporting these procedures, and one hospital in Massachusetts. Univariate and multivariate regression analyses were used to control for case mix. Clinical success was defined as at least one lesion dilated to <50% residual stenosis and no adverse outcomes. In-hospital adverse outcomes included coronary artery bypass graft surgery (CABG), myocardial infarction and mortality. RESULTS Over time, the population undergoing PCIs tended to be older with increasing comorbidity. After adjustment for case mix, clinical success continued to improve from a low of 88.2% in earlier years to a peak of 91.9% in recent years (p trend <0.001). The rate of emergency CABG after PCI fell in recent years from a peak of 2.3% to 1.3% (p trend <0.001). Mortality rates decreased slightly from 1.2% to 1.1% (p trend 0.007). CONCLUSIONS There has been a significant improvement in clinical outcomes for patients undergoing PCIs in northern New England, including a significant decline in the need for emergency CABG.

Cause of in-hospital death in 12,232 consecutive patients undergoing percutaneous transluminal coronary angioplasty ☆ ☆☆

BACKGROUND Some deaths after percutaneous coronary angioplasty (PTCA) occur in high-risk situations (eg, shock), whereas others are unexpected and related to procedural complications. To better describe the epidemiologic causes of death after PTCA, we undertook a systematic review of all in-hospital PTCA deaths in Northern New England from 1990 to 1993. METHODS The medical records of 121 patients who died during their acute hospitalization for PTCA were reviewed with a standardized data extraction tool to determine a mode of death (eg, low output failure, arrhythmia, respiratory failure) and a circumstance of death (eg, death attributable to a procedural complication, preexisting acute cardiac disease). Any death not classified as a procedural complication was reviewed by a committee and the circumstance of death assigned by a majority rule. RESULTS Low-output failure was the most common mode of death occurring in 80 (66.1%) of 121 patients. Other modes of death included ventricular arrhythmias (10.7%), stroke (4.1%), preexisting renal failure (4.1%), bleeding (2.5%), ventricular rupture (2.5%), respiratory failure (2.5%), pulmonary embolism (1.7%), and infection (1.7%). The circumstance of death was a procedural complication in 65 patients (53.7%) and a preexisting acute cardiac condition in 41 patients (33.9%). Women were more likely to die of a procedural complication than were men. CONCLUSION Procedural complications account for half of all post-PTCA deaths and are a particular problem for women. Other deaths are more directly related to patient acuity or noncardiac, comorbid conditions. Understanding why women face an increased risk of procedural complications may lead to improved outcomes for all patients.