Search

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.)

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.)

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.

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.

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: 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.

Background: In 1998, the International EECP Patient Registry (IEPR) was organized to document patient characteristics, safety, and efficacy during the treatment period, and long-term outcomes. All centers with EECP facilities were invited to join the voluntary Registry. The Registry population comprises all patients starting EECP therapy for treatment of angina pectoris in participating centers., Hypothesis: The study was undertaken to determine whether EECP is a safe and effective treatment for patients with angina pectoris regardless of their suitability for revascularization by more conventional techniques., Methods: After 18 months of operation, 43 clinical centers representing over half of clinical sites using the EECP system contributed cases. The data reported here were collected before the first EECP treatment and upon completion of final treatment. EECP can be used for patients ineligible for either coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI), as well as for those who prefer noninvasive treatment to avoid or delay revascularization. In this report, patients considered to be candidates for revascularization are compared with those not considered suitable., Results: Of the 978 patients analyzed, 70% had Canadian Cardiovascular Society Classification class III or IV angina before starting treatment, and 62% used nitroglycerin. Most (81%) had been previously revascularized, and 69% were considered unsuited for either PCI or CABG at the time of starting EECP. A full treatment course (usually 35 h) was completed in 86%, of whom 81% reported improvement of at least one angina class immediately after the last treatment., Conclusion: In a broad patient population, EECP has been shown to be a safe and effective treatment.

Background: Enhanced external counterpulsation (EECP) has been demonstrated to be an effective treatment for stable angina in patients with coronary disease. The hemodynamic effects of EECP are maximized when the ratio of diastolic to systolic pressure area is in the range of 1.5 to 2.0., Hypothesis: It is hypothesized that patients undergoing EECP who are able to achieve higher diastolic augmentation (DA) ratios may derive greater clinical benefit. This study examines the relationship between the DA ratio and clinical outcomes in patients undergoing EECP., Methods: We analyzed demographic, noninvasive hemodynamic, and clinical outcome data on 1,004 patients enrolled in the International EECP Patient Registry (IEPR) for treatment of chronic angina between January 1998 and August 1999. Blood pressure waveforms were recorded from finger plethysmography. Six-month clinical outcomes were obtained by telephone interview., Results: At the end of EECP treatment, 370 (37%) patients had a higher DA ratio (defined as > or = 1.5) and 634 (63%) had a lower DA ratio (defined as < 1.5). Factors associated with a lower DA ratio included age > or =65 years (p <0.001), female gender (p < 0.001), left ventricular ejection fraction < 35% (p < 0.05), hypertension (p < 0.01), prior coronary bypass surgery (p < 0.01), noncardiac vascular disease (p < 0.001), multivessel disease (p < 0.01), congestive heart failure (p < 0.01), current smoking (p < 0.01), unsuitability for further revascularization (p < 0.001), and higher baseline angina class (p < 0.001). There were no significant differences regarding diabetes mellitus, prior coronary angioplasty, prior myocardial infarction, or antianginal medication use between patients with higher or lower DA ratios. Based on a multiple logistic regression model, independent predictors of a DA ratio < 1.5 at the end of EECP included current smoking (odds ratio 3.3; 95% confidence intervals 2.0-5.4); multivessel disease (1.7; 1.3-2.3); female gender (2.2; 1.7-3.0); no prior EECP (1.9; 1.1-3.3); noncardiac vascular disease (2.3; 1.7-2.9); age > or = 65 years (1.7; 1.4-2.2), and patients not suitable for revascularization (1.6; 1.2-2.0). By the end of therapy, there were no significant differences in myocardial infarction, revascularization rates, or nitroglycerin use with respect to higher DA ratios. At 6-month follow-up, patients with higher DA had a trend toward a greater reduction in angina class compared with those with lower DA (p = 0.069). There was a significantly higher rate of unstable angina and congestive heart failure in the group not achieving higher augmentation (p < 0.05)., Conclusions: Patients who are younger, male, nonsmoking, and without multivessel coronary or noncardiac vascular disease are most likely to have higher DA with EECP. Patients with higher DA tended to have a greater reduction in angina class at 6-month follow-up compared with those with lower DA ratios. There is evidence that higher DA ratios are associated with improved short- or long-term clinical outcomes, suggesting that clinical benefit from EECP is associated with the magnitude of DA.

Objectives: We sought to determine the in-hospital clinical outcome and angiographic results of patients prospectively entered into the National Heart, Lung, and Blood Institute/New Approaches to Coronary Intervention (NHLBI/NACI) Registry who received Gianturco-Roubin stents as an unplanned new device., Background: Between August 1990 and March 1994, nine centers implanted Gianturco-Roubin flex stents as an unplanned new device in the initial treatment of 350 patients (389 lesions) who were prospectively enrolled in the NHLBI/NACI Registry., Methods: Patients undergoing implantation of the Gianturco-Roubin flex stent were prospectively entered into the Gianturco-Roubin stent portion of the NHLBI/NACI Registry. Only subjects receiving the Gianturco-Roubin stent as a new device in an unplanned fashion are included., Results: The mean age of the patient group was 61.8 years, and the majority of the patients were men. A history of percutaneous transluminal coronary angioplasty (PTCA) was present in 35.4% of the group, and 16.9% had previous coronary artery bypass graft surgery. Unstable angina was present in 67.7%. Double- or triple-vessel coronary artery disease was present in 55.4%, and the average ejection fraction was 58%. The presence of thrombus was noted in 7.3%, and 7.2% had moderate to severe tortuosity of the lesion. The angiographic success rate was 92%. Individual clinical sites reported that 66.3% of the stents were placed after suboptimal PTCA, 20.3% for abrupt closure and 13.4% for some other technical PTCA failure. Major in-hospital events occurred in 9.7% of patients, including death in 1.7%, Q wave myocardial infarction in 3.1% and emergency bypass surgery in 6%. Abrupt closure of a stented segment occurred in 3.1% of patients at a mean of 3.9 days. Cerebrovascular accident occurred in 0.3%, and transfusion was required in 10.6%. Vascular events with surgical repair occurred in 8.6% of patients., Conclusions: Despite these complications, the use of this device for the treatment of a failed or suboptimal PTCA result remains promising given the adverse outcome of abrupt closure with conventional (nonstent) treatment.