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Data from the International Enhanced External Counterpulsation (EECP) Patient Registry were analyzed to determine which patient characteristics influence improvement in angina class with EECP treatment. Patients with severely disabling angina at baseline, men, and those without a history of smoking are more likely to improve their angina class after EECP, whereas those with diabetes mellitus, prior bypass surgery, and heart failure were less likely to benefit. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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., (© 2015 Wiley Periodicals, Inc.)

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.

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.

Background: Effectiveness of medical therapies in chronic pancreatitis has been described in small studies of selected patients., Aim: To describe frequency and perceived effectiveness of non-analgesic medical therapies in chronic pancreatitis patients evaluated at US referral centres., Methods: Using data on 516 chronic pancreatitis patients enrolled prospectively in the NAPS2 Study, we evaluated how often medical therapies [pancreatic enzyme replacement therapy (PERT), vitamins/antioxidants (AO), octreotide, coeliac plexus block (CPB)] were utilized and considered useful by physicians., Results: Oral PERT was commonly used (70%), more frequently in the presence of exocrine insufficiency (EI) (88% vs. 61%, P < 0.001) and pain (74% vs. 59%, P < 0.002). On multivariable analyses, predictors of PERT usage were EI (OR 5.14, 95% CI 2.87-9.18), constant (OR 3.42, 95% CI 1.93-6.04) or intermittent pain (OR 1.98, 95% CI 1.14-3.45). Efficacy of PERT was predicted only by EI (OR 2.16, 95% CI 1.36-3.42). AO were tried less often (14%) and were more effective in idiopathic and obstructive vs. alcoholic chronic pancreatitis (25% vs. 4%, P = 0.03). Other therapies were infrequently used (CPB - 5%, octreotide - 7%) with efficacy generally <50%., Conclusions: Pancreatic enzyme replacement therapy is commonly utilized, but is considered useful in only subsets of chronic pancreatitis patients. Other medical therapies are used infrequently and have limited efficacy., (© 2010 Blackwell Publishing Ltd.)

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.

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., (Copyright (c) 2008 Wiley Periodicals, Inc.)

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.

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.

Patients with refractory angina often suffer from erectile dysfunction. Enhanced external counterpulsation (EECP) decreases symptoms of angina, and increases nitric oxide release. This study evaluated the effect of EECP on sexual function in men with severe angina. The International Index of Erectile Function (IIEF) was used to assess erectile function of severe angina patients enroled in the International EECP Patient Registry. Their symptom status, medication use, adverse clinical events and quality of life were also recorded before and after completing a course of EECP. A cohort of 120 men (mean age 65.0+/-9.7) was enroled. The men had severe coronary disease with 69% having a prior myocardial infarction, 90% prior coronary artery bypass graft or percutaneous coronary intervention, 49% with three vessel coronary artery disease, 86% were not candidates for further revascularisation, 71% hypertensive, 83% dyslipidaemia, 42% diabetes mellitus, 75% smoking and 68% using nitrates. Functional status was low with a mean Duke Activity Status Inventory score of 16.6+/-14.8. After 35 h of EECP anginal status improved in 89%, and functional status in 63%. A comparison of the IIEF scores pre- and post-EECP therapy demonstrated a significant improvement in erectile function from 10.0+/-1.0 to 11.8+/-1.0 (p=0.003), intercourse satisfaction (4.2+/-0.5 to 5.0+/-0.5, p=0.009) and overall satisfaction (4.7+/-0.3 to 5.3+/-0.3, p=0.001). However, there were no significant changes in orgasmic function (4.2+/-0.4 to 4.6+/-0.4, p=0.19) or sexual desire (5.3+/-0.2 to 5.5+/-0.2). The findings suggest that EECP therapy is associated with improvement in erectile function in men with refractory angina.

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

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., (2007 S. Karger AG, Basel)

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.

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.

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.

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.

Objective: To examine risk factors for major paravalvular leak (PVL) events after mechanical heart valve replacement., Methods: We analyzed outcome of 807 patients randomized into the Artificial Valve Endocarditis Reduction Trial (AVERT). The mean follow-up time was 30.6 months and 21 major PVL events were reported. Three additional major PVL events associated with endocarditis were excluded from analysis. All baseline medical history variables, as well as operative parameters (including use of pledgets and suture technique) were examined using Cox regression., Results: Major PVL was reported after 11 aortic, 9 mitral, and 1 double valve replacement. 6/404 (1.5%) patients with conventional valves experienced a major PVL event versus 15/403 (3.7%) in the Silzone group. 10/172 (5.8%) patients with valve suture technique without pledgets experienced a major PVL event versus 11/635 (1.7%) patients with pledgets. Final multivariable model showed that only suture technique without pledgets (p=0.005) was an independent significant risk factor for major PVL events. Silzone cuff showed a strong trend (p=0.055)., Conclusions: Suture technique without pledgets is an independent significant risk factor for major PVL events. In this study, use of pledgets during valve replacement had a protective effect against subsequent paravalvular leak, supporting the use of buttress reinforcement for valve suture. The use of Silzone cuff, although not statistically significant, showed a strong trend as a risk factor.

Background: Enhanced external counterpulsation (EECP) is effective in treating angina in coronary artery disease patients. Whether EECP produces similar immediate and sustained benefits and freedom from adverse events (MACE) at 1 year in patients with severe systolic dysfunction versus diastolic dysfunction is unknown., Methods and Results: Data of 746 angina patients with a history of heart failure enrolled in the International EECP Registry were divided into 2 groups: left ventricular ejection fraction (LVEF) < or =35% (S) and LVEF >35% (D). Mean LVEF was 51.0 +/- 10.2% in diastolic dysfunction (n=391) versus 26.3 +/- 6.9% in systolic dysfunction (n=355). At baseline, 92.0% of diastolic dysfunction and 90.9% of systolic had Canadian Cardiovascular Society Class III/IV angina with similar number of anginal episodes and nitroglycerin use. After 32 hours of EECP, angina was reduced by > or =1 class in 71.9% of diastolic versus 72.2% of systolic with similar decreases in anginal episodes and nitroglycerin use. At 1-year 78.1% of diastolic and 75.8% of systolic have less angina than pre-EECP. MACE at 1 year was also comparable (24.4 versus 23.8%)., Conclusions: The benefits of EECP in heart failure patients were similar regardless of diastolic or systolic dysfunction. The improvement was sustained at 1 year with similar MACE.

Enhanced external counterpulsation (EECP) has been shown to reduce Canadian Cardiovascular Society angina class. This study examines the factors that affect the reduction at 1 year, especially in patients who do not demonstrate an initial response. The data of 2,007 consecutive patients enrolled in the International EECP Patient Registry were analyzed. After 36.6 +/- 4.9 h of EECP, angina was reduced by at least one class in 82.7%. At 1 year, 35.4% of initial nonresponders and 70.6% of responders remained improved by at least one angina class and free of major adverse cardiovascular events. Multivariate predictors of 1-year benefit are initial response to treatment (odds ratio 4.5, 95% CI 3.5-5.8), baseline angina class compared with class IV (odds ratios: class I 2.1, CI 0.93-4.81; class II 0.62, CI 0.43-0.87; class III 0.80, CI 0.62-1.01) and no history of congestive heart failure (odds ratio 1.41, CI 1.14-1.74)., (Copyright 2005 S. Karger AG, Basel.)

Objectives: The purpose of this study was to determine the prevalence and severity of paravalvular regurgitation (PVR) in the Artificial Valve Endocarditis Reduction Trial (AVERT) cohort., Background: The initial AVERT cohort consisted of 807 patients randomized to receive either a Silzone-coated prosthetic valve or a conventional prosthetic valve; early clinical reports showed higher rates of valve explant caused by PVR for Silzone-coated prosthetic valve., Methods: Of the 678 eligible patients, 575 (85%) underwent postoperative transthoracic echocardiograms. The presence and severity of PVR were identified by color flow Doppler. Reviewers were blinded to the type of prosthetic valve and the demographic and clinical variables., Results: Among those who underwent echocardiography (Silzone-coated prosthetic valve, n = 285 and conventional prosthetic valve, n = 290), 59% had prosthetic aortic valves, 32% prosthetic mitral valves, and 9% had both; demographic and clinical findings (i.e., prosthetic valve endocarditis, thromboembolism, bleeding, and all-cause death) were similar for the two groups. Echocardiographically determined PVR was present in 50 valves: Silzone-coated prosthetic valve, 29 of 285 (10%) and conventional prosthetic valve, 21 of 290 (7%, p = NS); the severity of PVR was similar in both groups. Kaplan-Meier analysis showed no significant differences in PVR at 24 months from valve implantation between the two groups (24-month event-free rate: 93% Silzone-coated prosthetic valve vs. 94% conventional prosthetic valve, p = NS)., Conclusions: Excluding those patients who had initial prosthetic valve explant, the two-year echocardiographic follow-up of the AVERT cohort shows no statistically significant differences in the prevalence or severity of PVR in the Silzone-coated prosthetic valve compared with the conventional prosthetic valve. Further monitoring is warranted to determine whether these clinical outcomes remain similar on long-term follow-up.

Background: Enhanced external counterpulsation (EECP) is a noninvasive device that uses three pairs of sequentially inflated pneumatic cuffs applied to the lower extremities and synchronized with the heart beat to provide diastolic augmentation, increase coronary blood pressure and flow, venous return and cardiac output, and decrease afterload., Hypothesis: This study examines the safety and effectiveness of EECP therapy in patients with significant left main coronary artery disease (LMD)., Methods: In all, 2,861 patients enrolled in the International EECP Patient Registry (IEPR) were divided into three groups, those without LMD (n = 2,377), those with LMD and prior CABG (n = 431), and those with unbypassed LMD (n = 53)., Results: Patients with LMD, with or without prior CABG, were significantly more likely to have triple-vessel disease (98.1 and 88.7%, respectively) than patients without LMD (41.9%). Post-EECP, 74% without LMD, 75% with LMD with prior CABG, and 65% with unbypassed LMD improved their Canadian Cardiovascular Society (CCS) angina by at least one class (p = NS). There were no differences in the mean decrease in weekly angina episodes (7.1 vs. 8.0 vs. 7.6) and in the mean frequency of weekly nitroglycerin use (6.6 vs. 8.1 vs. 8.9). At 6-month follow-up, the CCS class improved further in all three groups, and there was a further reduction in mean weekly angina episodes (4.7 vs. 4.6 vs. 5.3) and nitroglycerin use (6.5 vs. 6.8 vs. 8.2). Kaplan-Meier life table analysis 8 months after starting EECP demonstrated a major cardiovascular event rate of 11.2% in patients without LMD, 15.6% in LMD with CABG, and 24.3% in LMD without prior CABG. Late mortality in unbypassed LMD was 13.2% (confidence interval [CI] 3.3-23.1) versus 4.8% (CI 2.7-7.1) in LMD with CABG, and 2.8% (CI 2.1-3.5) without LMD (p = 0.0039 by log-rank test)., Conclusion: Enhanced external counterpulsation is equally effective in relieving angina in patients with or without LMD. However, the significantly increased late mortality in patients with LMD without prior CABG suggests that early revascularization should be considered in these patients.

Background: Patients with diabetes are at greater risk for coronary events, yet they are less likely to benefit from revascularization than those without diabetes. Enhanced external counterpulsation has recently emerged as a treatment option for select patients with chronic stable angina., Methods: We examined baseline characteristics, angina response, and cardiac outcomes of patients with diabetes mellitus treated with Enhanced External Counterpulsation (EECP) for chronic stable angina. Data were collected from patients enrolled in the International EECP Patient Registry (IEPR) before and after a course of EECP, and at 1 year after completion of treatment., Results: Of 1532 IEPR patients studied, 43% had diabetes mellitus at baseline. Patients with diabetes were experiencing, on average, 11 episodes of angina per week. Most had been revascularized with prior percutaneous coronary intervention or coronary artery bypass graft surgery (86%) and most were considered unsuitable for either additional procedure (87%). Treatment was completed as prescribed in 79% of patients (mean, 32 hours). Immediately after EECP, 69% of patients with diabetes demonstrated a reduction in angina of > or =1 Canadian Cardiovascular Society angina class. After 1 year, maintenance of angina reduction was reported in 72% of patients with diabetes. Quality of life was significantly improved. Despite a high-risk profile among the diabetic group in this study, 1-year mortality was similar to coronary intervention registry populations., Conclusion: This study suggests that in select patients with diabetes, EECP can be a safe, effective, well-tolerated treatment option for the relief of angina.

This study was undertaken to determine whether enhanced external counterpulsation is a safe and effective treatment for angina in octogenarians. In this prospective observational study, demographic and clinical outcome data on patients consecutively enrolled in the International EECP Patient Registry was examined. Of the 3037 patients analyzed, 249 (8%) were >/=80 years old. Octogenarians were more likely to be female and have a history of congestive heart failure (41% vs. 29%; p<0.001). They were less likely to have had previous revascularization. Fewer patients in the octogenarian group (76% vs. 84%; p<0.01) completed a course of treatment. Of those octogenarian patients who completed treatment, 76% reported a reduction in angina and quality of life improved significantly. Adverse events related to treatment were low. At 6-month follow-up, 81% reported maintenance of angina improvement. Thus, enhanced external counterpulsation is a low-risk intervention that offers octogenarians the ability to return to more normal activity and a better quality of life., (Copyright 2003 Le Jacq Communications, Inc.)

Enhanced external counterpulsation (EECP) is effective in patients with angina refractory to medical therapy or revascularization. However, as a noninvasive treatment it should perhaps be considered the first-line treatment with invasive revascularization reserved for EECP failures or high-risk patients. The International EECP Patient Registry was used to analyze a cohort of patients with prior percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) (n = 4,454) compared with a group of patients (PUMPERS) who were candidates for PCI and/or CABG and chose EECP as their initial revascularization treatment (n = 215). The PUMPERS responded to treatment with EECP with decreased anginal episodes and nitroglycerin use and with improvement in their Canadian Cardiovascular Society functional class, similarly to previously revascularized patients. Treatment with EECP resulted in sustained, and often progressive, reduction in angina over the succeeding 6 months. Given the findings of this study, it is interesting to speculate on the possibility of using EECP as the primary revascularization intervention after medical therapy proves unsatisfactory.

The International Enhanced External Counterpulsation (EECP) Patient Registry tracks acute and long-term outcome for consecutive patients treated for chronic angina. Although EECP has previously been shown to be a safe and effective treatment for angina, little information is available on its use in patients with left ventricular (LV) dysfunction. This report compares the acute outcome and 6-month follow-up for a group of patients with severe LV dysfunction and a group of patients without LV dysfunction. Of 1,402 patients in the registry recruited in 1998-1999 who had recorded values of LV ejection fraction (LVEF) at baseline, 1,090 (77.7%) had preserved LV function (LVEF >35%) and 312 (22.3%) had LV dysfunction (LVEF

Enhanced external counterpulsation (EECP) has recently emerged as a treatment option for angina in selected patients suitable for revascularization with percutaneous coronary intervention (PCI). We compared baseline characteristics and 1-year outcome in 2 cohorts of PCI candidates presenting with stable symptoms: 323 patients treated with EECP in the International EECP Patient Registry (IEPR), and 448 NHLBI Dynamic Registry patients treated with elective PCI. Compared with patients receiving PCI, IEPR patients had a higher prevalence of many risk factors including prior PCI (53.0% vs 33.3%, p <0.001), prior coronary artery bypass grafting (42.1% vs 18.6%, p <0.001), prior myocardial infarction (56.4% vs 27.8%, p <0.001), history of congestive heart failure (16.8% vs 9.2%, p <0.01), and history of diabetes (37.9% vs 23.5%, p <0.001). Left ventricular ejection fraction was lower among IEPR patients (mean 50.3% vs 59.2%, p <0.001). At 1 year, survival was comparable in the 2 cohorts (98.7% IEPR vs 96.8% PCI, p = NS), as were rates of coronary artery bypass grafting during follow-up (4.5% IEPR vs 5.7% PCI, p = NS). At 1 year, 43.7% of IEPR patients reported no anginal symptoms compared with 73.4% of Dynamic Registry patients (p <0.001). Rates of severe symptoms (Canadian Cardiovascular Society class III, IV, or unstable) at 1 year were 15.5% among IEPR patients and 9.5% in the Dynamic Registry (p = 0.02). PCI candidates suitable for and treated with EECP had 1-year major event rates comparable to patients receiving elective PCI. Although PCI was associated with substantially lower rates of 1-year symptoms, EECP may be a safe treatment option for selected patients with obstructive coronary disease.

Background: The Artificial Valve Endocarditis Reduction Trial (AVERT) was designed to compare endocarditis rates in Silzone versus conventional valves. Recruitment ended January 21, 2000, because of higher rates of paravalvular leakage in patients receiving the Silzone prosthesis. The present analysis determined late event rates that might be used in the management of approximately 36,000 patients who have received the Silzone prosthesis., Methods: A total of 807 patients in 19 centers in North America and Europe were randomized. Mean age was 61+/-11 years; 41% were women. Operations included aortic valve replacement in 59%, mitral valve replacement in 32%, and aortic and mitral valve replacements in 9%; 41% had concomitant operations (26% coronary artery bypass grafting)., Results: Major paravalvular leakage (followed by repair, explant, or mortality) occurred in 18 of 403 patients receiving Silzone valves and 4 of 404 patients without Silzone valves (2-year event-free rates: 91.1% versus 98.9% conventional, p < 0.003). Similarly, 2-year freedom from any explant was lower in the Silzone arm (19 versus 2 events; 90.1% versus 99.4%, p = 0.0002). Rates of mortality and stroke were similar during follow-up., Conclusions: Continued follow-up of AVERT supports the conclusion that the Silzone prosthesis has increased risk of paravalvular leakage requiring reoperation. Overall survival is similar in the two groups.