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.

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.

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.

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.

Importance of implant technique on risk of major paravalvular leak (PVL) after St. Jude mechanical heart valve replacement: a report from the Artificial Valve Endocarditis Reduction Trial (AVERT).

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.

Predictors of benefit in angina patients one year after completing enhanced external counterpulsation: initial responders to treatment versus nonresponders.

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).

Effectiveness of enhanced external counterpulsation in patients with left main disease and angina.

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.

Analysis of baseline factors associated with reduction in chest pain in patients with angina pectoris treated by enhanced external counterpulsation.

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.

Enhanced External Counterpulsation for the relief of angina in patients with diabetes: safety, efficacy and 1-year clinical outcomes.

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.

Comparison of patients undergoing enhanced external counterpulsation and percutaneous coronary intervention for stable angina pectoris.

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.

Paravalvular leak and other events in silzone-coated mechanical heart valves: a report from AVERT.

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.