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OBJECTIVE: The aim of this study was to assess the efficacy and feasibility of an enhanced heart failure (HF) education with a 6-month telephone follow- up program in post-discharge ambulatory HF patients. METHODS: The Hit-Point trial was a multicenter, randomized, controlled trial of enhanced HF education with a 6-month telephone follow-up program (EHFP) vs routine care (RC) in patients with HF and reduced ejection fraction. A total of 248 patients from 10 centers in various geographical areas were randomized: 125 to EHFP and 123 to RC. Education included information on adherence to treatment, symptom recognition, diet and fluid intake, weight monitoring, activity and exercise training. Patients were contacted by telephone after 1, 3, and 6 months. The primary study endpoint was cardiovascular death. RESULTS: Although all-cause mortality didn't differ between the EHFP and RC groups (p=NS), the percentage of cardiovascular deaths in the EHFP group was significantly lower than in the RC group at the 6-month follow up (5.6% vs. 8.9%, p=0.04). The median number of emergency room visits was one and the median number of all cause hospitalizations and heart failure hospitalizations were zero. Twenty-tree percent of the EHFP group and 35% of the RC group had more than a median number of emergency room visits (p=0.05). There was no significant difference regarding the median number of all-cause or heart failure hospitalizations. At baseline, 60% of patients in EHFP and 61% in RC were in NYHA Class III or IV, while at the 6-month follow up only 12% in EHFP and 32% in RC were in NYHA Class III or IV (p=0.001). CONCLUSION: These results demonstrate the potential clinical benefits of an enhanced HF education and follow up program led by a cardiologist in reducing cardiovascular deaths and number of emergency room visits with an improvement in functional capacity at 6 months in post-discharge ambulatory HF patients.

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Medically refractory angina pectoris (RAP) is defined by presence of severe angina with objective evidence of ischemia and failure to relieve symptoms with coronary revascularization. Medication and invasive revascularization are the most common approaches for treating coronary artery disease (CAD). Although symptoms are eliminated or alleviated by these invasive approaches, the disease and its causes are present after treatment. New treatment approaches are needed to prevent the disease from progressing and symptoms from recurring. External enhanced counterpulsation therapy provides a treatment modality in the management of CAD and can complement invasive revascularization procedures. Data support that it should be considered a first-line treatment of RAP.

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BACKGROUND: Recent studies have suggested an association between radiation therapy (RT) of the left breast and increased incidence of coronary artery disease. However, the increased sparing afforded with modern RT may decrease long-term cardiac risk. The aims of our study were to evaluate the association between the RT and cardiac events in breast cancer patients who underwent contemporary RT and to examine whether breast arterial calcification (BAC) seen on mammogram predicts for cardiac events. METHODS AND MATERIALS: In our observational, descriptive pilot study, 2,439 patients with breast cancer between 1986 and 2007 and a minimum of 3 years since completing RT were asked to complete a questionnaire regarding cardiac events since RT completion. The preoperative and follow-up mammograms were coded for presence/absence of BAC by an experienced radiologist blinded to questionnaire results. Cardiac events were compared between patients who received left- and right-sided adjuvant radiation. RESULTS: At a mean follow-up of 7.5 years (range 3-24), 687 patients completed the questionnaire, with 602 eligible for analysis. Baseline characteristics (age, body mass index [BMI], surgery type, cardiovascular risk factors, and time since RT) were similar in patients who received left- versus right-sided RT. Hypertension before RT and during follow-up, baseline cardiovascular disease, age >50, BMI >30 kg/m², and subsequent development of diabetes were significantly associated with posttreatment cardiac events. BACs were associated with cardiac events reported before breast cancer diagnosis; however, no association was found between left-sided breast RT or BAC and subsequent cardiac events. CONCLUSION: In a large single-institutional observational study, no association was found between left-sided breast RT or BAC and subsequent cardiac events.

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Medically refractory angina pectoris (RAP) is defined by presence of severe angina with objective evidence of ischemia and failure to relieve symptoms with coronary revascularization. Medication and invasive revascularization are the most common approaches for treating coronary artery disease (CAD). Although symptoms are eliminated or alleviated by these invasive approaches, the disease and its causes are present after treatment. New treatment approaches are needed to prevent the disease from progressing and symptoms from recurring. External enhanced counterpulsation therapy provides a treatment modality in the management of CAD and can complement invasive revascularization procedures. Data support that it should be considered a first-line treatment of RAP.

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Diabetes mellitus (DM) is a metabolic disorder of multiple etiologies that causes long-term damage of various organs including the cardiovascular system. A consistent observation shows that DM amplifies the risk of cardiovascular events by 4- to 6-fold. Since coronary artery disease (CAD) in diabetic patients exhibits diffuse and accelerated lesions, invasive revascularization continues to be a challenge and has worse outcomes than patients without DM. Owing to the pathogenesis of DM and the presence of severe endothelial dysfunction, investigators have been trying to find new treatment modalities that could target the treatment of the disease rather than the treatment of the lesion. Until new treatment modalities are proven and gain acceptance, invasive revascularization remains to be the choice of treatment in such patients. The focus of this review is to compare the results of percutaneous coronary intervention (PCI) with coronary artery bypass grafting (CABG) for the treatment of stable CAD in patients with DM.

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

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OBJECTIVE: Functionally univentricular heart (FUH) anomalies are the leading cause of death from all structural birth defects. Total cavopulmonary connection (TCPC) is the last stage of the palliative surgical reconstruction with significant late hemodynamic complications requiring high-risk heart transplantation. Alternative therapeutic options for these critically ill patients are crucial. In Phase I, we investigated the effect of pulsatility of venous flow (VF) waveform on the performance of functional and "failing" Fontan (FF) patients based on conduit power loss. In phase 2, the effect of enhanced external counter pulsation on Fontan circulation flow rates is monitored. METHODS: In phase 1, Doppler VFs were acquired from FF patients with ventricle dysfunction. Using computational fluid dynamics (CFD), hemodynamic efficiencies of the FF, functional and in-vitro generated mechanically assisted VF waveforms were evaluated. In phase 2, Fontan circulation on sheep model was created and enhanced external counter pulsation (EECP) applied. RESULTS: Variations in the pulsatile content of the VF waveforms altered conduit efficiency notably. High frequency and low amplitude oscillations lowered the pulsatile component of power losses in FF VF waveforms. The systemic venous flow, pulmonary artery and aorta flows increased by utilizing EECP. CONCLUSION: Our data highlighted the significance of VF pulsatility on energy efficiency inside SV circulation and the feasibility of VF waveform optimization. EECP assist in Fontan circulation can result in venous flow augmentation.

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OBJECTIVE: Enhanced external counterpulsation (EECP) is a noninvasive treatment that is proven safe and effective in patients with coronary artery disease (CAD) and heart failure (HF). The aims of this study are to investigate the clinical effects of EECP therapy in patients with symptomatic CAD and chronic HF, and to find out an answer to the question: Does EECP therapy have any effect on the prognostic markers of HF? METHODS: This study was designed as a prospective cohort study. A total of 68 consecutive patients with symptomatic CAD and chronic HF referred to EECP therapy were enrolled in this study between November 2007 and December 2010; 47 patients (39 males and 8 females, 65 ± 7, years), have undergone EECP treatment, and 21 patients (20 males and 1 female, 62 ± 10 years), who did not want to participate in the EECP program comprised the control group. Statistical analysis was performed using t tests for dependent and independent samples, Mann-Whitney U test, Chi-square and Fischer exact tests. RESULTS: EECP therapy resulted in significant Improvement in post-intervention New York Heart Association functional class (p<0.001), left ventricular ejection fraction (p<0.001), B-type natriuretic peptide levels (p<0.003), uric acid levels (p<0.05), free-T3/free-T4 ratio (p<0.034) and mitral annular E (p<0.05) velocity, compared with baseline, a finding not evident in the control group. CONCLUSION: EECP treatment significantly improved clinical and some biochemical parameters, which are mostly prognostic markers in patients with symptomatic CAD and chronic HF.

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OBJECTIVE: To investigate the effect of pulsatility of venous flow waveform in the inferior and superior caval vessels on the performance of functional and "failing" Fontan patients based on two primary performance measures - the conduit power loss and the distribution of inferior caval flow (hepatic factors) to the lungs. METHODS: Doppler angiography flows were acquired from two typical extra-cardiac conduit "failing" Fontan patients, aged 13 and 25 years, with ventricle dysfunction. Using computational fluid dynamics, haemodynamic efficiencies of "failing", functional, and in vitro-generated mechanically assisted venous flow waveforms were evaluated inside an idealised total cavopulmonary connection with a caval offset. To investigate the effect of venous pulsatility alone, cardiac output was normalised to 3 litres per minute in all cases. To quantify the pulsatile behaviour of venous flows, two new performance indices were suggested. RESULTS: Variations in the pulsatile content of venous waveforms altered the conduit efficiency notably. High-frequency and low-amplitude oscillations lowered the pulsatile component of the power losses in "failing" Fontan flow waveforms. Owing to the offset geometry, hepatic flow distribution depended strongly on the ratio of time-dependent caval flows and the pulsatility content rather than mixing at the junction. "Failing" Fontan flow waveforms exhibited less balanced hepatic flow distribution to lungs. CONCLUSIONS: The haemodynamic efficiency of single-ventricle circulation depends strongly on the pulsatility of venous flow waveforms. The proposed performance indices can be calculated easily in the clinical setting in efforts to better quantify the energy efficiency of Fontan venous waveforms in pulsatile settings.

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OBJECTIVES: ACC/AHA/ESC guidelines recommend sublingual nitroglycerin (SNG) in patients with stable angina pectoris and coronary artery disease (CAD). However, the shelf life of SNG following first use is six months for SNG tablets and two years for SNG sprays. We investigated the frequency of prescription of SNG tablets/sprays in patients having anginal symptoms and documented CAD and the awareness levels of patients about appropriate use of SNG. STUDY DESIGN: Three hundred patients (201 men, 99 women; mean age 61.7±10.8 years) with documented CAD and angina were enrolled into this study. Angina pectoris was categorized according to the functional classification system of the Canadian Cardiovascular Society. Data on cardiovascular past histories, risk factors, medications, and the use of SNG were recorded. RESULTS: At least one risk factor was present in 96% of the patients. Only 46% of the patients had a prescription for SNG. Of those with a prescription of SNG tablet and spray, 91.8% and 84.4% did not know the shelf life of the product, respectively. Of those who were routinely carrying SNG, 35.6% had an expired product. Of those with a prescription of SNG, only 65.9% were informed by the physician on the proper use of SNG. CONCLUSION: Our results show that, despite recommendations of the guidelines, SNG is not prescribed to a substantial percentage of patients with CAD and angina, a considerable fraction of patients carry an expired product, and that patients are not adequately informed by the physicians on the use of SNG. These problems will certainly affect the optimal medical management of CAD and its efficacy.

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Despite significant advances in revascularization techniques and medical therapy, there remains a significant population of patients who continue to have intractable angina symptoms. This review aims to define the patients with refractory angina pectoris (RAP) and to present the therapeutic options currently available for this condition. RAP itself is defined and the pharmacological treatment options other than traditional medical therapies are discussed. The latest therapeutic options for this patient population are extensively reviewed. Among the multitude of pharmacological and non-invasive therapeutic options for patients with RAP, ranolazine is a new drug indicated for the treatment of chronic angina, in combination with amlodipine, beta-blockers or nitrates. Enhanced external counterpulsation has not only been shown to improve symptoms, but also to improve long-term ventricular function in these patients. In randomized trials, neurostimulation has been shown to be effective in reducing angina symptoms. Transmyocardial laser revascularization has emerged as an invasive treatment for RAP over the last two decades. Extracorporeal shockwave myocardial revascularization gene therapy and percutaneous in situ coronary venous arterialization are still under investigation.

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BACKGROUND: Prior studies suggest that disease management programs may be effective in improving clinical and economic outcomes in patients with heart failure. Whether these types of programs can lower health care cost and be adapted to the primary care setting is unknown. This study was designed to assess the impact of a home-based disease management program, the Alere DayLink HF Monitoring System (HFMS), on the clinical and economic outcomes of Medicare beneficiaries recently hospitalized for heart failure who received the care from a community-based primary care practitioner. METHODS AND RESULTS: The Heart Failure Home Care trial was a multicenter, randomized, controlled trial of sophisticated, monitoring of heart failure patients with an interactive program versus standard heart failure care with enhanced patient education and follow-up (SC) in Medicare-eligible patients. The study endpoints included cardiovascular death or rehospitalization for heart failure, length of hospital stay, total patient cost, and cost to Medicare at 6 months of enrollment. A total of 315 patients age ≥ 65 years old were randomized: 160 to the HFMS and 155 to SC. There were no significant statistical differences between the groups in regards to 6-month cardiac mortality, rehospitalizations for heart failure, or length of hospital stay. Of those, 304 patients had their Medicare data available. The information from the Medicare claims data was used to determine the cost. Information from the trial was used to determine costs of out-patient drugs and the interventions. The 6-month mean Medicare costs were estimated to be $17,837 and $13,886 for the HFMS and the SC groups, respectively. We found that overall medical costs of medicare patients were significantly higher for patients who were randomized to the HFMS arm than they were for the patients randomized to the SC arm. CONCLUSIONS: Our study results suggest that enhanced patient education and follow-up is as successful as a sophisticated home monitoring device with an interactive program and less costly in patients who are elderly and receive the care from a community-based primary care practitioner.

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OBJECTIVE: To determine the subclinical effects of isolated obesity and its duration on cardiac function by using routine echocardiography and tissue Doppler myocardial strain rate. METHODS: Forty-nine subjects were enrolled in this study; 29 with isolated obesity defined as a body mass index > or = 30 kg/m(2) with no other cardiovascular comorbidities, and 20 nonobese controls. All subjects underwent two-dimensional and Doppler echocardiography including tissue Doppler imaging and myocardial strain rate. RESULTS: The average duration of obesity was 12.1 years (4-18 years). Abnormalities of left ventricular (LV) wall thickness, mass, diastolic function, and left atrial size were detected in obese individuals, despite having preserved ejection fractions. The LV global longitudinal peak strain rate was significantly lower in obese subjects compared to nonobese control subjects (1.07 +/- 0.14 vs. 1.38 +/- 0.12, P < 0.001). Using multivariate analysis, the duration of obesity (ss=-0.76, P < 0.001), body mass index (ss=-0.35, P = 0.023), and age (ss=-0.29, P = 0.009) were independent predictors of the decreased LV global longitudinal peak strain rate, while the duration of obesity (ss=-0.66, P < 0.001) and body mass index (ss=-0.28, P = 0.037) were independent predictors of the decreased right ventricular (RV) peak strain rate. CONCLUSION: The presence and the duration of obesity were associated with impairment of subclinical biventricular systolic and diastolic function. These findings have the potential to increase awareness of subclinical cardiac manifestations in patients with isolated obesity and influence their early management.

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Coronary artery bypass surgery (CABG) and percutaneous coronary intervention (PCI) are both safe and established treatment modalities of invasive revascularization for patients with coronary artery disease (CAD). However, conflicting information exists when comparing the long-term efficacy of the two methods. The optimal treatment for patients with multivessel coronary artery disease (MVD) is still subject to discussion, given the lack of fairly designed, prospective, randomized data reflecting current practice in the modern era. Furthermore, the clinical outcomes after invasive revascularization differ according to the number of diseased vessels, presence or absence of diabetes, left main disease and left ventricular dysfunction. Hence, the question arises whether we should continue to use the term 'multivessel disease'. Conflicts of available data need to be addressed and overcome so that care of patients with CAD can be successfully tailored. In this review article we try to address some of the above conflicts, in an effort to improve our understanding in the care of patients with multivessel disease. We also provide an evidence-based perspective which may differ from the current standard of practice.

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Refractory angina pectoris, defined as angina refractory to maximal medical therapy and standard coronary revascularization procedures, remains a significant health problem in the United States and the world. Despite a panoply of recent therapeutic advances, patients with refractory angina pectoris are not adequately treated; therefore, scientists have been investigating new technologies to help these patients. The technique of counterpulsation, studied for almost half a century, is considered a safe, highly beneficial, low-cost, noninvasive treatment for these angina patients and now also for those with heart failure. Recent evidence suggests that enhanced external counterpulsation (EECP) therapy may improve symptoms and decrease long-term morbidity via several mechanisms, including improvement in endothelial function, promotion of collateralization, enhancement of ventricular function, improvement in oxygen consumption (Vo(2)), regression of atherosclerosis, and peripheral "training effects" similar to exercise. Numerous clinical trials in the past two decades have shown EECP therapy to be safe and effective for patients with refractory angina, with a clinical response rate averaging 70% to 80%, which is sustained up to 5 years. This review summarizes the current evidence to support EECP's use in treating refractory angina pectoris.

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BACKGROUND: Prior studies suggest that disease management programs may be effective in improving clinical outcomes in patients with heart failure (HF). However, the use of these programs in settings with limited sources and among diverse population is not know. Thus the present study was designed to assess the impact of a computer-based home disease management program (Alere DayLink HF Monitoring System [HFMS]) on the clinical outcomes of Medicare beneficiaries with HF who were elderly, women, and non-white males who received the care from a community-based primary care practitioner. METHODS AND RESULTS: The Heart Failure Home Care (HFHC) trial was a multicenter, randomized, controlled trial of HFMS versus standard heart failure care (SC: enhanced patient education, education to clinicians, and follow-up). The primary study end point was treatment failure, defined as a composite of cardiovascular death or rehospitalization for heart failure within 6 months of enrollment. Among patients rehospitalized for HF, length of hospital stay was also considered a primary end point. A total of 315 patients were randomized: 160 to HFMS and 155 to SC. Although the incidence of the primary outcome was somewhat higher in the SC arm (28.8% versus 21.2%, P = .15), the difference was not statistically different. The length of hospital stay was also similar in both groups. CONCLUSIONS: Our study results suggest that enhanced patient education and follow-up is as successful as a sophisticated home monitoring device with an interactive program in patients with HF who are elderly, women and non-Caucasian males and receive the care from a community-based primary care practitioner.

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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.

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BACKGROUND: Targeted anti-tumor necrosis factor (TNF) strategies in patients with rheumatoid arthritis have resulted in new and/or worsening heart failure in individuals who were free of cardiovascular disease. METHODS AND RESULTS: To determine the mechanism of new and/or worsening heart failure in patients who were receiving the soluble TNF-antagonist etanercept, we analyzed frozen plasma samples from a previous clinical trial with etanercept in heart failure patients, and conducted complimentary mechanistic in vitro studies. Analysis of the clinical trial data showed that use of etanercept resulted in a significant 70-fold increase in the level of immunoreactive TNF. Complimentary in vitro studies using an L929 bioassay showed that at low concentrations of etanercept relative to TNF there was an unexpected 1.5- to 1.75-fold increase in the absolute level of TNF bioactivity. We also examined the effect of etanercept on TNF stability and the results showed that there was a two-fold increase in the mass of bioactive homotrimeric TNF when the molar ratio of TNF to etanercept was approximately 200:1. CONCLUSION: Etanercept increases the immunoreactive mass of TNF in heart failure patients, as well as augments TNF cytotoxicity in certain settings, thus suggesting one potential mechanism for the worsening heart failure in some patients who were receiving this agent.

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This study assessed the effects of a course of enhanced external counterpulsation (EECP) therapy on systolic and diastolic cardiac function using echocardiography to measure left ventricular ejection fraction (LVEF), end-systolic volume (ESV), end-diastolic volume (EDV), systolic wave (Sm), early diastolic wave (Ea), Vp, E/Ea, E/Vp, and diastolic function grade in 25 patients before and after 35 hours of EECP. EECP reduced ESV and EDV and increased ejection fraction significantly in patients with baseline LVEF < or = 50% (P=.018, .013, .002), baseline E/Ea > or = 14 (P=.032, .038, .007), baseline grade II or III diastolic dysfunction (decreased compliance) (P=.014, .032, .027), baseline Ea <7 cm/s (P=.015, .024, .001), and baseline Sm <7 cm/s (P=.017, .016, .006), but not in patients with baseline LVEF >50%, baseline E/Ea <14, baseline normal diastolic function or grade I diastolic dysfunction (impaired relaxation), baseline Ea > or = 7 cm/s, and Sm > or = 7 cm/s. These results demonstrate improved systolic and diastolic function in selected patients and provide new insight into potential clinical applications of EECP.

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