Clinical Profile, Etiology, and Treatment of Chronic Pancreatitis in North American Women: Analysis of a Large Multicenter Cohort.

OBJECTIVE: Historically, chronic pancreatitis (CP) was considered a disease of alcoholic males, but recent data suggest its etiology to be complex. To better understand CP in women, we compared data on women and men with CP in a large, prospectively ascertained multicenter US cohort. METHODS: Patients with CP enrolled in the NAPS2 Continuation and Validation study were studied. Information on demographics, etiology, risk factors, phenotype, and treatment(s) used was obtained from detailed questionnaires completed by the patients and physicians. RESULTS: Of 521 cases, 45% were women. Women were significantly (P < 0.05) less likely to have alcohol etiology (30% vs 58.5%) and more likely to have nonalcoholic etiologies (idiopathic, 32% vs 18%; obstructive, 12% vs 2.4%; genetic, 12.8% vs 7.3%). Demographics, pain experience, morphologic findings, exocrine and endocrine insufficiency, CP-related disability, and use of medical therapies were mostly similar in both sexes. Sphincterotomy (biliary, 33% vs 24%; pancreatic, 38% vs 28%; P < 0.05) was performed more frequently in women, whereas cyst/pseudocyst operations were more common in men (6.6 vs 2.6%, P = 0.02). CONCLUSIONS: Most CP cases in women are from nonalcoholic etiologies. In contrast to many other chronic diseases, clinical phenotype of CP is determined by the disease and is independent of sex.

Enhanced External Counterpulsation Is Cost-Effective in Reducing Hospital Costs in Refractory Angina Patients.

BACKGROUND: Enhanced external counterpulsation (EECP) is effective in the treatment of refractory angina, a condition suffered by 1.7 million Americans. Declining cardiovascular mortality and appropriate use criteria may further increase this number. HYPOTHESIS: EECP is hypothesized to be cost-effective in reducing hospitalizations in refractory angina patients. METHODS: The data used in this analysis were collected in phase II of the International EECP Patient Registry (IEPR-II). Data were collected on changes in Canadian Cardiovascular Society functional class, Duke Activity Status Index, and number of hospitalizations in the 6 months prior to EECP and in the 6- and 12-month intervals following EECP. Estimates of the changes in annual cost of all-cause hospitalization before and after EECP therapy were calculated by the product of the differences in hospitalization rates in the 6-month interval before and after EECP treatment and estimated hospitalization and physician charges after subtracting the average cost of EECP. RESULTS: Data for 1015 patients were analyzed. Hospitalization occurred in 55.2% of patients, an average of 1.7 ± 1.4 hospitalizations/patient, in the 6-month period before 35 hours of EECP; and in 24.4%, an average of 1.4 ± 1.0 hospitalizations/patient, during the 6- to 12-month period after EECP. The average hospitalization and physician charge in the US was $17,995, and the average EECP cost was $4880, yielding an annual cost savings/patient of $17,074. CONCLUSIONS: Treatment of refractory angina patients with EECP resulted in improvement in angina and functional class accompanied by a sustained reduction in health care costs over 1 year of follow-up.

Spectrum of use and effectiveness of endoscopic and surgical therapies for chronic pancreatitis in the United States.

OBJECTIVE: This study aims to describe the frequency of use and reported effectiveness of endoscopic and surgical therapies in patients with chronic pancreatitis treated at US referral centers. METHODS: Five hundred fifteen patients were enrolled prospectively in the North American Pancreatitis Study 2, where patients and treating physicians reported previous therapeutic interventions and their perceived effectiveness. We evaluated the frequency and effectiveness of endoscopic (biliary or pancreatic sphincterotomy, biliary or pancreatic stent placement) and surgical (pancreatic cyst removal, pancreatic drainage procedure, pancreatic resection, surgical sphincterotomy) therapies. RESULTS: Biliary and/or pancreatic sphincterotomy (42%) were the most common endoscopic procedure (biliary stent, 14%; pancreatic stent, 36%; P < 0.001). Endoscopic procedures were equally effective (biliary sphincterotomy, 40.0%; biliary stent, 40.8%; pancreatic stent, 47.0%; P = 0.34). On multivariable analysis, the presence of abdominal pain (odds ratio, 1.82; 95% confidence interval, 1.15-2.88) predicted endoscopy, whereas exocrine insufficiency (odds ratio, 0.63; 95% confidence interval, 0.42-0.94) deterred endoscopy. Surgical therapies were attempted equally (cyst removal, 7%; drainage procedure, 10%; resection procedure, 12%) except for surgical sphincteroplasty (4%; P < 0.001). Surgical sphincteroplasty was the least effective (46%; P < 0.001) versus cyst removal (76% drainage [71%] and resection [73%]). CONCLUSIONS: Although surgical therapies were performed less frequently than endoscopic therapies, they were more often reported to be effective.

Physical and mental quality of life in chronic pancreatitis: a case-control study from the North American Pancreatitis Study 2 cohort.

OBJECTIVES: The objective of this study was to define the quality of life (QOL) in patients with chronic pancreatitis (CP). METHODS: We studied 443 well-phenotyped CP subjects and 611 control subjects prospectively enrolled from 20 US centers between 2000 and 2006 in the North American Pancreatitis Study 2. Responses to the SF-12 questionnaire were used to calculate the mental (MCS) and physical component summary scores (PCS) with norm-based scoring (normal ≥50). Quality of life in CP subjects was compared with control subjects after controlling for demographic factors, drinking history, smoking, and medical conditions. Quality of life in CP was also compared with known scores for several chronic conditions. RESULTS: Both PCS (38 [SD, 11.5] vs 52 [SD, 9.4]) and MCS (44 [SD, 11.5] vs 51 [SD, 9.2]) were significantly lower in CP compared with control subjects (P < 0.001). On multivariable analyses, compared with control subjects, a profound decrease in physical QOL (PCS 12.02 points lower) and a clinically significant decrease in mental QOL (MCS 4.24 points lower) was seen due to CP. Quality of life in CP was similar to (heart, kidney, liver, lung disease) or worse than (nonskin cancers, diabetes mellitus, hypertension, rheumatoid arthritis) other chronic conditions. CONCLUSIONS: The impact of CP on QOL appears substantial. The QOL in CP subjects appears to be worse or similar to the QOL of many other chronic conditions.

Comparison of long term clinical outcomes, event free survival rates of patients undergoing enhanced external counterpulsation for coronary artery disease in the United States and Turkey.

OBJECTIVES: This study assessed the long-term efficacy of EECP (Enhanced External Counterpulsation) in Turkish (TR) patients initially and compared these results with the United States (US) in a real world setting. STUDY DESIGN: In this study, 2072 patients were treated and followed in the US and 82 patients were treated and followed in TR. The International EECP Patient Registry Phase I and II was initiated and coordinated at the University of Pittsburgh. The aim of the "registry" was to assess the outcomes of clinical trials in a real world setting. Another unique feature of this study was to enroll patients not only from university hospitals but also from private hospitals, educational hospitals, and treatment centers. RESULTS: TR patients had less diabetes, hypertension, and hyperlipidemia than US patients (p<0.01). TR patients also had a higher proportion of diastolic augmentation (p<0.001). Both groups showed a significant reduction in the severity of angina after a 35 h EECP course (p<0.001). Major Adverse Cardiac Events (MACE) rate (death, coronary artery bypass graft, percutaneous coronary intervention, myocardial infarction) was low in both groups during treatment (2.5% vs. 2.7%). At 1 year follow up, 84% of TR and 76% of US patients had maintained the improvement of angina. CONCLUSION: Patients presenting for EECP treatment from TR had different baseline profiles from US patients. However, despite the high risk baseline characteristics, both cohorts achieved similar reduction in angina. In the long term follow-up, the MACE rate was low and the improvement after EECP was sustained in most of the patients.

Relationship of serum pancreatic enzyme testing trends with the diagnosis of acute pancreatitis.

OBJECTIVE: The reasons for increasing incidence of acute pancreatitis (AP) are not completely understood. We hypothesized that the rate of serum pancreatic enzyme (PE) testing is increasing, and it correlates with AP diagnosis. METHODS: We retrieved electronic patient data for all emergency department visits at 2 University of Pittsburgh Medical Center hospitals (UPMC Presbyterian [PUH] from 1996 to 2005, N = 422,745; UPMC St Margaret Hospital [SMH] from 1999 to 2005, N = 202,171). We evaluated the trends for serum PE testing (amylase, lipase, or both) and correlated this with the proportion of visits resulting in an inpatient discharge diagnosis of AP. RESULTS: Serum PE testing increased significantly from 4.6% (95% CI, 4.4-4.9) in 1996 to 9.5% (95% CI, 9.3-9.7) in 2005. On multivariate modeling, the rates for serum PE testing were higher at SMH (vs PUH: OR, 1.53; 95% CI, 1.50-1.57), among females (vs males: OR, 1.30 [95% CI, 1.28-1.33]), and increased with age (OR, 1.06 [95% CI, 1.05-1.06] for each 10 years). The proportion of ED visits resulting in an inpatient discharge diagnosis of AP increased significantly during the study period and correlated highly with the rate of PE testing. CONCLUSIONS: The rate of serum PE testing is increasing. Increased serum PE testing may be contributing to the increase in the incidence of AP.

The efficacy and safety of enhanced external counterpulsation in patients with peripheral arterial disease.

Peripheral arterial disease (PAD) is common in patients with severe coronary artery disease (CAD) and is considered a relative contraindication to external enhanced counterpulsation (EECP), but there are no data that define the efficacy and safety of EECP in patients with PAD. The International EECP Patient Registry (IEPR) was used to compare initial post-therapy and 2-year follow-up clinical outcomes and adverse event rates in patients with and without PAD. From January 2002 to October 2004, 2126 patients were enrolled in the IEPR, of whom 493 (23%) had a history of PAD. Immediately following EECP, the reduction in angina (> or = 1 Canadian Cardiovascular Society class) was similar in patients with and without PAD (76.6% vs 79.0%, p = 0.27) as was improvement in the Duke Activity Score Index (DASI) score (+4.7% vs +6.1%, p < 0.001). Both angina reduction and DASI score improvement were sustained at 2 years. PAD patients discontinued EECP more frequently (12.0% vs 8.5%, p < 0.05), but lower extremity ulceration did not occur more frequently in patients with PAD (3.7% vs 2.7%, p = 0.26). Rates of death (17.1% vs 8.6%, p < 0.001) and myocardial infarction (9.5% vs 5.0%, p < 0.001) were, as expected, higher in patients with PAD compared to patients without PAD at 2 years. In conclusion, while PAD patients constitute a high-risk cohort with known higher adverse event rates, EECP led to similar short- and long-term improvements in angina and quality of life for individuals with PAD compared to those without PAD.

Use of nonmedical treatments by infertility patients.

OBJECTIVE: To discover the extent to which infertility patients use alternatives to traditional medical treatment and to identify factors that may promote patients to use them. STUDY DESIGN: Women seeking treatment for infertility at a private office in the Midwest were offered a questionnaire inquiring about their use of nonmedical therapies. Participants were asked about demographic information, types of medical and nonmedical treatments used and the reasons for using them. RESULTS: Of 133 patients who completed questionnaires, 88 (62.2%) indicated use of alternative therapies. The most common were religious intervention (33.8%), changes in sexual practices (28.6%) and dietary changes (21.8%). Patients using alternative therapies were significantly younger than those who did not (33.2 vs. 35.6, p < 0.01), but there were no significant differences between the groups in 'education, parity or length of infertility. The most common reasons given for using alternative methods were "No harm in trying" (56.8%) and "To supplement traditional therapies" (46%). CONCLUSION: Alternative or complementary methods are used by a majority of infertility patients, particularly those who are younger. Patients indicate that such methods complement rather than compete with traditional medical methods.

Passive tobacco exposure may impair symptomatic improvement in patients with chronic angina undergoing enhanced external counterpulsation.

BACKGROUND: The adverse effects of tobacco abuse on cardiovascular outcomes are well-known. However, the impact of passive smoke exposure on angina status and therapeutic response is less well-established. We examined the impact of second-hand smoke (SHS) exposure on symptomatic improvement in patients with chronic ischemic coronary disease undergoing enhanced external counterpulsation (EECP). METHODS: This observational study included 1,026 non-smokers (108 exposed and 918 not-exposed to SHS) from the Second International EECP Patient Registry. We also assessed angina response in 363 current smokers. Patient demographics, symptomatic improvement and quality of life assessment were determined by self-report prior and after EECP treatment. RESULTS: Non-smoking SHS subjects had a lower prevalence of prior revascularization (85% vs 90%), and had an increased prevalence of stroke (13% vs 7%) and prior smoking (72% vs 61%; all p < 0.05) compared to non-smokers without SHS exposure. Despite comparable degrees of coronary disease, baseline angina class, medical regimens and side effects during EECP, fewer SHS non-smokers completed a full 35-hour treatment course (77% vs 85%, p = 0.020) compared to non-smokers without SHS. Compared to non-smokers without SHS, non-smoking SHS subjects had less angina relief after EECP (angina class decreased > or = 1 class: 68% vs 79%; p = 0.0082), both higher than that achieved in current smokers (66%). By multivariable logistic regression, SHS exposure was an independent predictor of failure to symptomatic improvement after EECP among non-smokers (OR 1.81, 95% confidence intervals 1.16-2.83). CONCLUSION: Non-smokers with SHS exposure had an attenuated improvement in anginal symptoms compared to those without SHS following EECP.

Enhanced external counterpulsation in the treatment of chronic refractory angina: a long-term follow-up outcome from the International Enhanced External Counterpulsation Patient Registry.

BACKGROUND: The management of patients who suffer from medically refractory angina and are unsuitable for conventional revascularization therapy is often unsatisfactory. Enhanced external counterpulsation (EECP) is a noninvasive treatment that is safe and effective immediately after a course of treatment. However, the duration of benefit is less certain. HYPOTHESIS: To evaluate the 3-year outcome of EECP treatment. METHODS: One thousand four hundred and twenty seven patients from 36 centers registered in the International EECP Patient Registry (IEPR)-Phase 1 was prospectively followed for a median of 37 months. Two hundred and twenty patients (15.4%) died, while 1,061 patients (74.4%) completed their follow-up. RESULTS: The mean age was 66+/-11 years and 72% were men. Seventy-six percent had multivessel coronary disease for 11+/-8 years. Eighty-eight percent had a prior percutaneous or surgical revascularization and 82% were unsuitable for further coronary intervention. Immediately post-EECP, the proportion of patients with severe angina (Canadian Cardiovascular Angina Classification [CCS] III/IV) were reduced from 89% to 25%, p<0.001. The CCS class was improved by at least 1 class in 78% of the patients and by at least 2 classes in 38%. This was sustained in 74% of the patients during follow-up.Thirty-six percent of the patients had CCS II or less angina, which was better than pre-EECP state without a major adverse cardiovascular event during follow-up. More severe baseline angina and a history of heart failure or diabetes were independent predictors of unfavorable outcome. CONCLUSION: An EECP improves angina and quality of life immediately after a course of treatment. For most of the patients, these beneficial effects are sustained for 3 years.

Residual high-grade angina after enhanced external counterpulsation therapy.

OBJECTIVE: We evaluated the degree of residual angina on the outcomes of enhanced external counterpulsation (EECP) therapy for chronic stable angina. BACKGROUND: Angina refractory to medical therapy is common in the pool of patients who are not completely revascularized by angioplasty or bypass surgery. METHODS: We examined 902 patients enrolled from 1998 to 2001 in the Second International Enhanced External Counterpulsation Patient Registry. Baseline and outcome variables were stratified by the last recorded Canadian Cardiovascular Society class. RESULTS: Residual Class 3 (12.1%) or 4 (2.3%) angina was uncommon among patients with severe coronary artery disease after treatment with EECP. Prevalence of diabetes, hypertension, dyslipidemia, and heart failure was similar among the anginal post-EECP anginal classes. Multivessel coronary disease was more common in those with higher-grade angina at completion. More frequent and severe angina at entry was more common in those with the higher anginal classes at EECP (P<.001). There were no differences in the rates of chronic medications utilized or prior revascularization. At 3-year follow-up, rates of death, myocardial infarction, percutaneous coronary intervention, and coronary artery bypass surgery tended to be higher across increasing residual angina classes. The composite cardiac event rates were 34%, 33%, and 44% for those with Class 0, Class 1/2, and Class 3/4 angina at EECP completion (P=.01), respectively. Multivariate analysis for the composite endpoint found residual Class 3/4 angina (OR=1.59, 95% CI=1.19-2.17, P=.002), diabetes (OR=1.57, 95% CI=1.23-2.01, P=.0003), age (per decile OR=1.17, 95% CI=1.04-1.31, P=.007), and greater EECP augmentation (OR=0.79, 95% CI=0.65-0.96, P=.02) as significant predictors. CONCLUSIONS: Residual high-grade angina after EECP occurs in those with more severe angina and multivessel disease at baseline and is associated with cardiac events over the next 3 years. These data suggest that close clinical observation and intensive management of those with high-grade angina post-EECP are warranted.

The effects of enhanced external counterpulsation on time- and frequency-domain measures of heart rate variability.

BACKGROUND AND PURPOSE: We hypothesized that symptom improvement from enhanced external counterpulsation (EECP) is related to improved heart rate variability (HRV). METHODS: This prospective, multicenter study enrolled 27 patients with angina who underwent 48-hour ambulatory electrocardiogram monitoring at baseline, immediately after 35 hours of EECP, and at 1 month. Primary end points included change in time-domain (SD of normal-to-normal intervals) and frequency-domain HRV. RESULTS: Twenty-four patients completed the full course of EECP therapy and 3 ambulatory electrocardiograms. There were no significant changes in time-domain HRV measures after EECP. Patients younger than 65 years and those with heart failure had improved SD of normal-to-normal interval after EECP (P = .02). Although frequency-domain HRV measures did not change in the overall cohort, patients with diabetes had improved daytime low-frequency power (P = .016). CONCLUSIONS: There was no significant change in the time- or frequency-domain HRV measures after EECP. In diabetic individuals, there was an increase in low-frequency HRV, which has been associated with reduced mortality.

Impact of external counterpulsation treatment on emergency department visits and hospitalizations in refractory angina patients with left ventricular dysfunction.

Patients with refractory angina and left ventricular (LV) dysfunction exert an enormous burden on health care resources primarily because of the number of recurrent emergency department (ED) visits and hospitalizations. Enhanced external counterpulsation (EECP) therapy has emerged as a treatment option for patients with angina and LV dysfunction and has been shown to improve clinical outcomes and LV function. Improvements in symptoms and laboratory assessments in these patients, however, do not necessarily correlate with a reduction in ED visits and hospitalizations. This is the first study to assess the impact of EECP therapy on ED visits and hospitalization rates at 6-month follow-up. This prospective cohort study included 450 patients with LV dysfunction (ejection fraction

Effectiveness of repeat enhanced external counterpulsation for refractory angina in patients failing to complete an initial course of therapy.

AIMS: This study examined the causes and results of retreatment of patients who failed to complete an initial 35-hour Enhanced External Counterpulsation (EECP) course. METHODS AND RESULTS: Data of 2,311 successive angina patients from the International EECP Patient Registry were analyzed, 86.5% completed their EECP course (Complete cohort). Of the 13.5% patients failing to complete the initial course (Incomplete cohort), 28.3% had repeat EECP within 1 year vs. 10.1% of the Complete group. The predictors of failure to complete the initial course of EECP were: female gender, heart failure, use of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and use of nitroglycerin. For the Complete group, 83.4% had a reduction of at least one Canadian Cardiovascular Society (CCS) class after their initial EECP course, vs. 21.7% in the Incomplete group (p < 0.001). After repeat treatment, 66.2% of the Incomplete group achieved at least one CCS class reduction vs. 69.4% of the Complete group (p = NS) undergoing retreatment. The independent predictors for those who return to successfully complete their second course were patients who stopped their first course because of clinical events, and candidacy for coronary artery bypass grafting at the time of initial treatment. CONCLUSION: The results of retreatment of those who failed to complete their initial EECP course were comparable to those who completed their initial treatment, with similar reductions of CCS angina class.

Primer: practical approach to the selection of patients for and application of EECP.

Over the past decade, the frequency of use of enhanced external counterpulsation (EECP) has increased in patients with angina, irrespective of medical therapy and coronary revascularization status. Many patients referred for EECP have one or more comorbidities that could affect this treatment's efficacy, safety, or both. By use of data from more than 8,000 patients enrolled in the International EECP Patient Registry, we provide practical guidelines for the selection and treatment of patients. We have focused on considerations for patients who have one or more of the following characteristics: age older than 75 years, diabetes, obesity, heart failure, and peripheral vascular disease. We have also reviewed outcomes and treatment recommendations for individuals with poor diastolic augmentation during treatment, for those with atrial fibrillation or pacemakers, and for those receiving anticoagulation therapy. Lastly, we examined relevant data regarding extended courses of EECP, repeat therapy, or both. While clinical studies have demonstrated the usefulness of EECP in selected patients, these guidelines permit recommendations for the extended application of this important treatment to subsets of patients excluded from clinical trials.

Time-related risk of the St. Jude Silzone heart valve.

OBJECTIVE: The St. Jude Medical Silzone heart valve had a silver-impregnated sewing ring designed to reduce the incidence of prosthetic valve endocarditis. Recruitment to the randomized AVERT study comparing Silzone valves with non-Silzone Control valves was stopped because of an increased risk of reoperation for paravalvular leak, but patient follow-up continues. Determining the time-related risk profile of the Silzone valve is important for helping physicians manage the approximately 28,000 patients currently alive with a Silzone valve. METHODS: Between 1998 and 2000, 403 Silzone and 404 Control patients were enrolled in AVERT. As of July 2005, there were 1819 Silzone and 1842 Control patient-years of follow-up (mean 4.5, median 5.1 years). Analysis emphasized the use and interpretation of hazard functions, since they are more meaningful than event-free percentages to currently surviving patients. To this end, instead of Cox regression, which estimates the hazard ratio, assuming it is constant over time, we employed primarily Aalen additive regression, which measures the hazard difference, and produces a plot of it over time. We assessed the risks of major paravalvular leak, endocarditis, bleeding and thrombo-embolism. RESULTS: The Silzone valve had a higher initial risk of major paravalvular leak than Control in the mitral (p=0.02) position, but not in the aortic (p=0.42) position. Analysis of this risk using additive regression, with all valve positions combined, showed that the initial risk due to Silzone lost statistical significance by 2 years and disappeared by 4 years after implant. In the mitral position, the Silzone valve had a higher initial risk of thrombo-embolism plus bleeding than Control; this risk also lost statistical significance by 2 years and subsided to zero by 4 years. The risks for death and endocarditis were similar for Slizone and Control valves. CONCLUSIONS: The additional risks of the Silzone valve, compared to Control, diminish over time and disappear by 4 years after implant. The minimum time after implant of the patients currently alive with Silzone is now well beyond 5 years; thus, these current patients now have a risk profile similar to that of patients with a standard St. Jude valve.

Two-year outcomes in patients with mild refractory angina treated with enhanced external counterpulsation.

BACKGROUND: In the International Enhanced External Counterpulsation Patient Registry (IEPR), approximately 85% of the patients treated are in Canadian Cardiovascular Society (CCS) class III-IV with no option for further invasive coronary revascularization procedures. HYPOTHESIS: This study sought to determine whether it is clinically important to establish whether the observed durable reduction in disabling severe angina with enhanced external counterpulsation (EECP) treatment can be extended to those with less severe CCS class II angina, who also have no option for further revascularization. METHODS: This study evaluated the immediate response, durability and clinical events over a 2-year period after EECP treatment in 112 patients with Canadian Cardiovascular Society (CCS) class II angina versus 1346 patients with class III-IV angina using data from the International EECP Patient Registry (IEPR). RESULTS: Treatment with EECP significantly (by at least one CCS class) reduced angina frequency, nitroglycerin use, and improved quality of life in both groups. At 2-year follow-up, 74% of class II and 70% of class III-IV patients remained free of major adverse cardiovascular events (MACE) and continued to demonstrate a durable CCS class improvement over baseline. CONCLUSION: The robust effectiveness of EECP as a noninvasive device, together with its relatively low start-up and recurrent costs, makes it an attractive consideration for treating patients with milder refractory angina in addition to the patient with severely disabling angina treated in current practice.

Impact of body mass index on outcomes of enhanced external counterpulsation therapy.

OBJECTIVES: We evaluated the association of baseline body mass index (BMI) on the outcomes of enhanced external counterpulsation (EECP) therapy for chronic stable angina. BACKGROUND: We are in the midst of a pandemic of obesity, which is complicating the care of patients with coronary artery disease (CAD). METHODS: We examined 2730 patients enrolled from 2002 to 2004 in the IEPR-2. Baseline and outcome variables were stratified by the entry BMI in kilograms per meter squared. RESULTS: Obesity (BMI > 30 kg/m2) was common (40.6%) among patients with severe CAD referred for EECP. Within the total cohort, 2.6% was underweight (BMI < or = 20 kg/m2) and 4.5% was morbidly obese (BMI > 40 kg/m2). Prevalence of diabetes, hypertension, dyslipidemia, and heart failure (HF) was higher in obese patients. However, the rates of baseline angina and prior revascularization were similar among the groups. The peak diastolic augmentation ratio was similar between groups during the first (0.7 +/- 0.4 for lowest and highest BMI) and last hours of treatment (0.9 +/- 0.5 and 0.8 +/- 0.5). The cumulative hours of treatment, the change in angina class, and the Duke Activity Status Index were similar for all BMI groups. There was a greater reduction in weekly anginal episodes from baseline across ascending levels of BMI (-6.3 +/- 13.6 to -9.7 +/- 15.8, P = .03). The rates of discontinuation for clinical events were highest (14.3%) with skin breakdown being the most frequent cause (10.1%) in the underweight. The rates of clinical events including myocardial infarction, HF, and death trended higher across ascending levels of BMI (P = .52). Multivariate analysis found that older age, history of stroke, history of HF, and diabetes, but not BMI, were predictors of clinical events. CONCLUSIONS: More than 40% of patients with severe CAD referred for EECP were obese. Underweight patients had higher rates of discontinuation of treatment mainly because of skin breakdown. Symptomatic benefit of EECP was similar among all BMI groups. However, despite symptomatic improvement, there was a nonsignificant trend for higher rates of myocardial infarction, HF, and death as BMI increased.

Two-year clinical outcomes after enhanced external counterpulsation (EECP) therapy in patients with refractory angina pectoris and left ventricular dysfunction (report from The International EECP Patient Registry).

Enhanced external counterpulsation (EECP) is a noninvasive circulatory assist device that has recently emerged as a treatment option for refractory angina in left ventricular (LV) dysfunction. This 2-year cohort study describes the long-term follow-up of patients who had severe LV dysfunction that was treated with EECP for angina pectoris and reports clinical outcomes, event-free survival rates, and the incidence of repeat EECP. This study included 363 patients who had refractory angina and LV ejection fraction < or =35%. Most patients reported quality of life as poor. After completion of treatment, there was a significant decrease in severity of angina class (p < 0.001), and 72% improved from severe angina to no angina or mild angina. Fifty-two percent of patients discontinued nitroglycerin use. Quality of life improved substantially. At 2 years this decrease in angina was maintained in 55% of patients. The 2-year survival rate was 83%, and the major adverse cardiovascular event-free survival rate was 70%. Forty-three percent had no reported cardiac hospitalization; 81% had no reported congestive heart failure events. Repeat EECP was performed in 20% of these patients. The only significant independent predictor of repeat EECP in a proportional hazard model was failure to complete the first EECP treatment course (hazard ratio 2.9, 95% confidence interval 1.7 to 4.9). Improvements in angina symptoms and quality of life were maintained at 2 years. In conclusion, for patients who have high-risk LV dysfunction, EECP offers an effective, durable therapeutic approach for refractory angina. Decreased angina and improvement in quality of life were maintained at 2 years, with modest repeat EECP and low major cardiovascular event rates.