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Biomedical subjects

Marc A Silver

Publications and source records attributed to Marc A Silver.

At least 19 recordsLinked to original sources
PubMed2006

Enhanced external counterpulsation improves exercise tolerance in patients with chronic heart failure.

OBJECTIVES: The PEECH (Prospective Evaluation of Enhanced External Counterpulsation in Congestive Heart Failure) study assessed the benefits of enhanced external counterpulsation (EECP) in the treatment of patients with mild-to-moderate heart failure (HF). BACKGROUND: Enhanced external counterpulsation reduced angina symptoms and extended time to exercise-induced ischemia in patients with coronary artery disease, angina, and normal left ventricular function. A small pilot study and registry analysis suggested benefits in patients with HF. METHODS: We randomized 187 subjects with mild-to-moderate symptoms of HF to either EECP and protocol-defined pharmacologic therapy (PT) or PT alone. Two co-primary end points were pre-defined: the percentage of subjects with a 60 s or more increase in exercise duration and the percentage of subjects with at least 1.25 ml/min/kg increase in peak volume of oxygen uptake (VO2) at 6 months. RESULTS: By the primary intent-to-treat analysis, 35% of subjects in the EECP group and 25% of control subjects increased exercise time by at least 60 s (p = 0.016) at 6 months. However, there was no between-group difference in peak VO2 changes. New York Heart Association (NYHA) functional class improved in the active treatment group at 1 week (p < 0.01), 3months (p < 0.02), and 6 months (p < 0.01). The Minnesota Living with Heart Failure score improved significantly 1 week (p < 0.02) and 3 months after treatment (p = 0.01). CONCLUSIONS: In this randomized, single-blinded study, EECP improved exercise tolerance, quality of life, and NYHA functional classification without an accompanying increase in peak VO2.

Aged↗
PubMed2006

Utility of impedance cardiography for the identification of short-term risk of clinical decompensation in stable patients with chronic heart failure.

OBJECTIVES: This study sought to assess the potential utility of impedance cardiography (ICG) in predicting clinical deterioration in ambulatory patients with heart failure (HF). BACKGROUND: Impedance cardiography uses changes in thoracic electrical impedance to estimate hemodynamic variables, but its ability to predict clinical events has not been evaluated. METHODS: We prospectively evaluated 212 stable patients with HF and a recent episode of clinical decompensation who underwent serial clinical evaluation and blinded ICG testing every 2 weeks for 26 weeks and were followed up for the occurrence of death or worsening HF requiring hospitalization or emergent care. RESULTS: During the study, 59 patients experienced 104 episodes of decompensated HF (16 deaths, 78 hospitalizations, and 10 emergency visits). Multivariate analysis identified 6 clinical and ICG variables that independently predicted an event within 14 days of assessment. These included three clinical variables (visual analog score, New York Heart Association functional class, and systolic blood pressure) and three ICG parameters (velocity index, thoracic fluid content index, and left ventricular ejection time). The three ICG parameters combined into a composite score was a powerful predictor of an event during the next 14 days (p = 0.0002). Visits with a high-risk composite score had 2.5 times greater likelihood and those with a low-risk score had a 70% lower likelihood of a near-term event compared with visits at intermediate risk. CONCLUSIONS: These results suggest that when performed at regular intervals in stable patients with HF with a recent episode of clinical decompensation, ICG can identify patients at increased near-term risk of recurrent decompensation.

Adult↗
PubMed2006

Mechanisms and evidence for the role of enhanced external counterpulsation in heart failure management.

Balloon counterpulsation has gained widespread acceptance as a therapy for cardiogenic shock. However, over the past four decades a parallel method of noninvasive counterpulsation, enhanced external counterpulsation (EECP), has been defined and developed. Mechanisms of benefit for this technology continue to emerge and include enhanced coronary and other key target organ perfusion beds. Other mechanisms include angiogenesis and enhanced cellular metabolism. Beyond putative mechanisms there is ample evidence for improved and sustained outcomes in patients with and without left ventricular dysfunction. This evidence comes from long-term registry reports and randomized clinical trials. With respect to heart failure (HF), there is registry, pilot trial, and randomized clinical trial evidence of safety and efficacy. This paper summarizes some of the mechanisms and outcomes of EECP in HF patients and helps to elucidate the role of EECP in the management of patients with chronic HF.

Counterpulsation↗
PubMed2006

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.

Aged↗
PubMed2006

Management of aortic insufficiency with continuous flow left ventricular assist devices: bioprosthetic valve replacement.

There are several methods for surgical management of aortic insufficiency in patients with end-stage congestive heart failure who are undergoing implantation of a left ventricular assist device (LVAD). To date, little is known about the long-term outcome of bioprosthetic valves for aortic insufficiency in patients with continuous flow LVADs. We report on two patients with bioprosthetic aortic valve replacement for aortic insufficiency at the time of HeartMate II LVAD insertion.

Aged↗
PubMed2006

The natriuretic peptide system: kidney and cardiovascular effects.

PURPOSE OF REVIEW: The natriuretic peptide (NP) system is primarily an endocrine system that maintains fluid and pressure homeostasis by modulating cardiac and renal function. The physiologic functions of the NP system in healthy humans and in patients with cardiovascular disease are not fully understood. NP levels are elevated in patients with heart failure (HF) and other cardiac diseases; measurement of NPs may be used in the clinical setting to aid diagnosis and prognosis. In addition, synthetic NPs such as nesiritide are available for use in management of patients with acutely decompensated congestive HF. RECENT FINDINGS: Not only do NPs modulate volume and pressure homeostasis, but they also exert important anti-proliferative, anti-fibrotic effects in the heart. Thus, NPs may prove useful for prevention of remodeling after myocardial infarction and in advanced HF. BNP is emerging as an important biomarker in patients with HF and other cardiovascular diseases, such as pulmonary hypertension and atherosclerotic vascular disease. Elevated NP levels may serve as an early warning system to help to identify patients at high risk for cardiac events. Recombinant human ANP (carperitide) and BNP (nesiritide) are useful for management of acutely decompensated HF; these drugs are also being investigated for myocardial and renal protection in the setting of cardiac surgery and for prevention of cardiac remodeling. SUMMARY: The clinical application of NPs is expanding rapidly. Recent basic science and clinical research findings continue to improve our understanding of the NP system and guide use of ANP and BNP as biomarkers and as therapeutic agents.

Biomarkers↗
PubMed2005

ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure): developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: endorsed by the Heart Rhythm Society.

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Adult↗
PubMed2005

Impact of nonfatal myocardial infarction on outcomes in patients with advanced heart failure and the effect of bucindolol therapy.

We sought to identify the clinical characteristics and outcomes of patients who had advanced heart failure and nonfatal myocardial infarction (MI) in the beta-Blocker Evaluation of Survival Trial (BEST) and to investigate whether bucindolol alters the risk of developing nonfatal MI. Of the 2,708 patients enrolled in the study, 142 had suspected MI and 69 had confirmed MI; there were 860 deaths overall. The rate of nonfatal MI in the BEST was low over the 4.1 years of follow-up (4.8% had suspected events and 2.4% had adjudicated events) and was similar to that in high-risk populations. Cox's proportional hazard model with 23 prespecified candidate variables associated advanced age, heart failure symptoms, male gender, ischemic etiology, diabetes, and hypertension with nonfatal MI or cardiovascular death. The 2-year mortality rate was 56% for the cohort that had suspected nonfatal MI versus 30% for the cohort that did not (p = 0.01). Likewise, the risk of hospitalization for congestive heart failure was twofold greater. Beta-blocker therapy with bucindolol resulted in a 52% decrease in suspected nonfatal MI (2.9% vs 5.5%, p = 0.001). In conclusion, nonfatal MI occurs at low rates but increases the risks for mortality and hospitalization in patients who have advanced heart failure. Beta-blocker therapy with bucindolol appears to attenuate the risk of nonfatal MI in this population.

Adrenergic beta-Antagonists↗
PubMed2005

Nesiritide added to standard care favorably reduces systolic blood pressure compared with standard care alone in patients with acute decompensated heart failure.

The Prospective Randomized Outcomes study of Acutely decompensated Congestive heart failure Treated Initially as Outpatients with Nesiritide (PROACTION) trial evaluated the safety of nesiritide administration in the emergency department in patients with decompensated heart failure. Patients (N=237) were treated for at least 12 hours with standard care plus either intravenous nesiritide or placebo. Compared to placebo, nesiritide favorably decreased systolic blood pressure (SBP) in patients with elevated baseline SBP, without negatively impacting patients with lower baseline SBP (SBP, >140 mm Hg: nesiritide, -28.7 mm Hg, vs placebo, -8.4 mm Hg [P<.001]; SBP, 101-140 mm Hg: nesiritide, -12.3 mm Hg, vs placebo, -5 mm Hg [P<.017]; SBP, <101 mm Hg: nesiritide, -1.2 mm Hg vs placebo, +16.7 mm Hg [P<.03]). Both treatment groups had similar incidences of symptomatic and asymptomatic hypotension. These data demonstrate that early administration of nesiritide in the emergency department is a safe and effective treatment of heart failure.

Aged↗
PubMed2005

Angina patients with diastolic versus systolic heart failure demonstrate comparable immediate and one-year benefit from enhanced external counterpulsation.

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.

Aged↗
PubMed2005

Treating heart failure with enhanced external counterpulsation (EECP): design of the Prospective Evaluation of EECP in Heart Failure (PEECH) trial.

BACKGROUND: Enhanced external counterpulsation (EECP) treatment can improve exercise tolerance in patients with ischemic heart disease; however, the possible benefits of EECP in patients with stable heart failure (HF) and left ventricular dysfunction (LVD) are unclear. An open pilot study showed significant increases in exercise tolerance in HF patients undergoing EECP. Thus a larger, controlled study of EECP in patients with stable HF (New York Heart Association [NYHA] classes II and III) and LVD was undertaken. METHODS AND RESULTS: The PEECH trial is a controlled, randomized, single-blind, parallel-group, multicenter study of 187 patients with symptomatic but stable HF (NYHA classes II and III) and an LV ejection fraction < or =35% was designed to assess the efficiency of EECP in patients with stable HF. Medical therapy is optimized in all patients based on the recommendations of the Heart Failure Society of America ("Usual Care"), and then randomized between 2 treatment groups; UC or EECP (35 hours over 7 weeks). CONCLUSION: Efficacy measures include standard exercise tolerance tests on a treadmill (modified Naughton protocol), with measurements of peak oxygen uptake and exercise duration time; quality of life questionnaires; NYHA classification; and neurohormonal markers of HF.

Counterpulsation↗
PubMed2005

Systemic hypertension among women with uterine leiomyomata: potential final common pathways of target end-organ remodeling.

The uterus and the heart share a common structure and may remodel in a similar fashion, albeit temporally distinct. The authors investigated the prevalence of systemic hypertension in women with uterine leiomyomata (fibroids) and compared the prevalence in women undergoing hysterectomy for other reasons as well as in age-matched women from the National Health and Nutrition Examination Survey III (NHANES III). A total of 584 women, 205 with leiomyomata in 1999 (group A) and 379 who underwent hysterectomy for a variety of reasons in 2000 (group B) at Advocate Christ Medical Center were included. Presence of leiomyomata was confirmed by pathology. Hypertension was defined as blood pressure > or = 140/90 mm Hg or history of hypertension with or without medication use. The prevalence of hypertension in group A and B patients with leiomyomata compared with NHANES III overall was 48.6% vs. 24% (p<0.001), in African Americans 55.5% vs. 32.4% (p<0.001), and in Caucasians 51.1% vs. 23.3% (p<0.001). Leiomyomata were more frequent among hypertensive than normotensive women (57% vs. 27%). Caucasian and African-American women with leiomyomata were significantly younger and more likely to use hormone replacement therapy than others. Thus there appears to be an association between leiomyomata and hypertension, which needs to be explored in future prospective trials.

Adult↗
PubMed2004

Safety and feasibility of using serial infusions of nesiritide for heart failure in an outpatient setting (from the FUSION I trial).

The Follow-Up Serial Infusions of Nesiritide pilot study was designed to assess the safety and tolerability of outpatient serial infusions of nesiritide in 210 patients with decompensated heart failure who were randomly assigned to usual care only or usual care plus weekly infusions of nesiritide at dosages of 0.005 or 0.01 microg/kg/min for 12 weeks. The mean age +/- SD of the entire population was 67 +/- 13 years; 70% were men, and 80% were white. Mean baseline serum creatinine levels were 1.8 +/- 0.7 mg/dl, and mean left ventricular ejection fraction was 0.28 +/- 0.15%. Diabetes mellitus was present in 106 patients (50%), and atrial arrhythmias were present in 100 patients (48%). A totalof 1,645 nesiritide infusions was administered; 11 (< 1%) were discontinued due to an adverse event. All treatment groups had a similar frequency of adverse events and experienced improvements in quality of life. Administration of nesiritide resulted in acute decreases in aldosterone and endothelin-1 concentrations. Although there were no statistically significant differences among groups by outcome, prospectively defined higher risk subgroups demonstrated significant decreases in cardiovascular events. These results demonstrate the safety and feasibility of administering nesiritide in an outpatient setting. Additional studies are needed to determine the effect of outpatient serial infusions of nesiritide on rates of morbidity and mortality in advanced heart failure.

Aged↗
PubMed2004

Efficacy of nonsteroidal anti-inflammatory medications for prevention of atrial fibrillation following coronary artery bypass graft surgery.

This study was designed to test whether nonsteroidal anti-inflammatory medications could reduce the frequency of atrial fibrillation after coronary artery bypass graft surgery. The study was designed as an open-label, randomized trial. Patients undergoing first-time coronary artery bypass graft surgery were considered eligible. Patients with a history of atrial fibrillation, serum creatinine >2.0 mg/dL, on antiarrhythmic treatment, and those undergoing concomitant valvular surgery were excluded. The study was conducted in a single, university-affiliated community hospital. The researchers' role in the study was restricted to randomizing the patients and collecting data. The primary clinical care team made all decisions regarding patient care. One hundred patients were randomized to two groups: one received 30 mg ketorolac intravenously every 6 hours until able to take oral medications, at which point the patients were switched to 600 mg ibuprofen orally three times a day; the other group received conventional treatment. The primary end point of the study was incidence of atrial fibrillation in the immediate postoperative period. Atrial fibrillation occurred in 14 patients (28.6%) in the conventional treatment group vs. five patients (9.8%) in the ibuprofen group (p<0.017). Nonsteroidal anti-inflammatory medications were relatively safe and effective in significantly reducing the incidence of atrial fibrillation after coronary artery bypass graft surgery.

Aged↗
PubMed2004

Optimizing treatment of chronic decompensated heart failure in the outpatient setting.

Chronic decompensated heart failure (HF) is costly to manage because of frequent episodes of acute decompensation that result in hospitalization. Patients with chronic decompensated HF may have inadequate hemodynamic responses or limited tolerance of oral HF medications and therefore may require parenteral administration of vasoactive agents. Intermittent infusions of inotropic agents are no longer recommended, but preliminary data suggest that intermittent nesiritide may be a safe and effective adjunct to oral drug therapy for select patients at risk for further episodes of decompensation. In other patients, nonpharmacologic approaches used in combination with drug therapy may help improve functional status and reduce mortality.

Ambulatory Care↗