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BACKGROUND: Cardiac contractility modulation (CCM) signals are nonexcitatory electrical signals delivered during the absolute refractory period intended to improve contraction. We previously tested the safety and efficacy of CCM in 428 NYHA functional class III/IV heart failure patients with EF <=35% and narrow QRS randomized to optimal medical treatment (OMT) plus CCM (n = 215) versus OMT alone (n = 213) and found no significant effect on ventilatory anaerobic threshold (VAT), the study's primary end point. In the present analysis, we sought to identify if there was a subgroup of patients who showed a response to CCM. METHODS AND RESULTS: The protocol specified that multiregression analysis would be used to determine if baseline EF, NYHA functional class, pVO(2), or etiology of heart failure influenced the impact of CCM on AT. Etiology and baseline pVO(2) did not affect efficacy. However, baseline NYHA functional class III and EF >=25% were significant predictors of increased efficacy. In this subgroup (comprising 97 OMT and 109 CCM patients, ~48% of the entire population) VAT increased by 0.10 ± 2.36 in CCM versus -0.54 ± 1.83 mL kg(-1) min(-1) in OMT (P = .03) and pVO(2) increased by 0.34 ± 3.11 in CCM versus -0.97 ± 2.31 (P = .001) at 24 weeks compared with baseline; 44% of CCM versus 23% of OMT subjects showed improvement of >=1 class in NYHA functional class (P = .002), and 59% of CCM versus 42% of OMT subjects showed a >=10-point reduction in Minnesota Living with Heart Failure Questionnaire (P = .01). All of these findings were similar to those seen at 50 weeks. CONCLUSIONS: The results of this retrospective hypothesis-generating analysis indicate that CCM significantly improves objective parameters of exercise tolerance in a subgroup of patients characterized by normal QRS duration, NYHA functional class III symptoms, and EF >25%. [ABSTRACT FROM AUTHOR]

The development of an implantable haemodynamic monitor (IHM) has made possible the home monitoring of a patient's central haemodynamic trends during daily living. We have evaluated the usability and transmission success of such a system over a 3.2-year period. Patients with an IHM were able to transmit the stored data every week to a Web server, where trend plots and tables of haemodynamic variables could be viewed by the health-care staff concerned. Data transfer was examined from August 2000 to November 2003. During this period, 148 patients had an IHM implanted. Over the study period, 7791 data transmissions were performed and an average of 286 downloads per month were sent to the Web server. In all, 86% of data transmissions were successful, although 10% required more than one attempt. The study demonstrated that telemonitoring of haemodynamic data from an IHM was feasible. A patient survey showed that the technology was user-friendly and that the training material provided sufficient information for patients and their families to install and use the transmission equipment at home. It also suggested that transmission success was independent of patient age or gender. [ABSTRACT FROM AUTHOR]

Background: Pulmonary hypertension is a progressive and often fatal complication of the scleroderma spectrum of disease for which no treatment has been proven effective in a randomized trial.Objective: To determine the effect of epoprostenol on pulmonary hypertension secondary to the scleroderma spectrum of disease.Design: Randomized, open-label, controlled trial.Setting: 17 pulmonary hypertension referral centers.Patients: 111 patients with moderate to severe pulmonary hypertension.Intervention: Epoprostenol plus conventional therapy or conventional therapy alone.Measurements: The primary outcome measure was exercise capacity. Other measures were cardiopulmonary hemodynamics, signs and symptoms of pulmonary hypertension and scleroderma, and survival.Results: Exercise capacity improved with epoprostenol (median distance walked in 6 minutes, 316 m at 12 weeks compared with 270 m at baseline) but decreased with conventional therapy (192 m at 12 weeks compared with 240 m at baseline). The difference between treatment groups in the median distance walked at week 12 was 108 m (95% CI, 55.2 m to 180.0 m) (P < 0.001). Hemodynamics improved at 12 weeks with epoprostenol. The changes in mean pulmonary artery pressure for the epoprostenol and conventional therapy groups were -5.0 and 0.9 mm Hg, respectively (difference, -6.0 mm Hg [CI, -9.0 to -3.0 mm Hg), and the mean changes in pulmonary vascular resistance were -4.6 and 0.9 mm Hg/L per minute, respectively (difference, -5.5 mm Hg/L per minute [CI, -7.3 to -3.7 mm Hg/L per minute). Twenty-one patients treated with epoprostenol and no patients receiving conventional therapy showed improved New York Heart Association functional class. Borg Dyspnea Scores and Dyspnea-Fatigue Ratings improved in the epoprostenol group. Trends toward greater improvement in severity of the Raynaud phenomenon and fewer new digital ulcers were seen in the epoprostenol group. Four patients in the epoprostenol group and five in the conventional therapy group died (P value not significant). Side effects of epoprostenol therapy included jaw pain, nausea, and anorexia. Adverse events related to the epoprostenol delivery system included sepsis, cellulitis, hemorrhage, and pneumothorax (4% incidence for each condition).Conclusions: Continuous epoprostenol therapy improves exercise capacity and cardiopulmonary hemodynamics in patients with pulmonary hypertension due to the scleroderma spectrum of disease. [ABSTRACT FROM AUTHOR]

An abstract of the study "Cancion Cardiac Recovery System in Severe Heart Failure: Initial U.S. Results of Acute and Sustained Hemodynamic and Clinical Impact," by B. Czerska and colleagues is presented.

Patients with ischemic heart disease and significant left ventricular dysfunction are often difficult to manage medically. Revascularization procedures may improve left ventricular function and prognosis in this population if hypocontractile yet viable myocardium (hibernating myocardium) is demonstrated. Nuclear cardiology studies (single photon and positron methods), two-dimensional echocardiography, and magnetic resonance imaging studies have been utilized to identify hibernating myocardium. If thallium-201 studies are performed, the use of reinjection of thallium and repeat imaging improves the sensitivity of these studies for the detection of viable myocardium. Dobutamine echocardiographic studies may have a higher specificity and positive predictive value for the subsequent improvement of regional systolic left ventricular function after revascularization than the nuclear techniques. However, thallium studies have an excellent negative predictive value. Positron emission tomography (PET) allows the simultaneous assessment of perfusion and metabolic activity; however, these studies are expensive and not widely available. Functional evaluation with PET is in its infancy. Functional cardiac magnetic resonance imaging (MRI), although not widely available yet, provides the most accurate evaluation of regional ventricular function. MRI spectroscopy may be utilized to assess myocardial viability. As acquisition times improve and "real-time" imaging becomes a reality, MRI and MRI spectroscopy will likely become very accurate tools for assessing functional reserve and metabolic activity. The selection of the most appropriate method for assessment of myocardial viability will include consideration of a patient's characteristics, the presence of coronary arterial tree amenable to revascularization techniques, the techniques available to the clinician to assess viability, and local revascularization experience in this population. The result of an individual patient's evaluation is relevant to the consideration of coronary revascularization, or if this is not possible, cardiac transplantation. [ABSTRACT FROM AUTHOR]

Background: Cardiac contractility modulation (CCM) delivers nonexcitatory electrical signals to the heart during the absolute refractory period intended to improve contraction., Methods: We tested CCM in 428 New York Heart Association class III or IV, narrow QRS heart failure patients with ejection fraction (EF) ≤ 35% randomized to optimal medical therapy (OMT) plus CCM (n = 215) versus OMT alone (n = 213). Efficacy was assessed by ventilatory anaerobic threshold (VAT), primary end point, peak Vo₂ (pVo₂), and Minnesota Living with Heart Failure Questionnaire (MLWFQ) at 6 months. The primary safety end point was a test of noninferiority between groups at 12 months for the composite of all-cause mortality and hospitalizations (12.5% allowable delta)., Results: The groups were comparable for age (58 ± 13 vs 59 ± 12 years), EF (26% ± 7% vs 26% ± 7%), pVo₂ (14.7 ± 2.9 vs 14.8 ± 3.2 mL kg⁻¹ min⁻¹), and other characteristics. While VAT did not improve at 6 months, CCM significantly improved pVo₂ and MLWHFQ (by 0.65 mL kg⁻¹ min⁻¹ [P = .024] and -9.7 points [P < .0001], respectively) over OMT. Forty-eight percent of OMT and 52% of CCM patients experienced a safety end point, which satisfied the noniferiority criterion (P = .03). Post hoc, hypothesis-generating analysis identified a subgroup (characterized by baseline EF ≥ 25% and New York Heart Association class III symptoms) in which all parameters were improved by CCM., Conclusions: In the overall target population, CCM did not improve VAT (the primary end point) but did improve pVo₂ and MLWHFQ. Cardiac contractility modulation did not have an adverse affect on hospitalizations or mortality within the prespecified boundaries. Further study is required to clarify the role of CCM as a treatment for medically refractory heart failure., (Copyright © 2011 Mosby, Inc. All rights reserved.)

Objectives: we sought to determine whether patients with functional mitral regurgitation (FMR) would benefit from ventricular reshaping by the Coapsys device (Myocor, Inc., Maple Grove, Minnesota)., Background: FMR occurs when ventricular remodeling impairs valve function. Coapsys is a ventricular shape change device placed without cardiopulmonary bypass to reduce FMR. It compresses the mitral annulus and reshapes the ventricle. We hypothesized that Coapsys for FMR would improve clinical outcomes compared with standard therapies., Methods: RESTOR-MV (Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve) was a randomized, prospective, multicenter study of patients with FMR and coronary disease with core laboratory analysis. After enrollment, patients were stratified to the standard indicated surgery: either coronary artery bypass graft alone or coronary artery bypass graft with mitral valve repair. In each stratum, randomization was to either control (indicated surgery) or treatment (coronary artery bypass graft with Coapsys ventricular reshaping)., Results: the study was terminated when the sponsor failed to secure ongoing funding; 165 patients were randomized. Control and Coapsys both produced decreases in left ventricular (LV) end-diastolic dimension and MR at 2 years (p < 0.001); Coapsys provided a greater decrease in LV end-diastolic dimension (p = 0.021). Control had lower MR grades during follow-up (p = 0.01). Coapsys showed a survival advantage compared with control at 2 years (87% vs. 77%) (hazard ratio: 0.421; 95% confidence interval: 0.200 to 0.886; stratified log-rank test; p = 0.038). Complication-free survival (including death, stroke, myocardial infarction, and valve reoperation) was significantly greater with Coapsys at 2 years (85% vs. 71%) (hazard ratio: 0.372; 95% confidence interval: 0.185 to 0.749; adjusted log-rank test; p = 0.019)., Conclusions: analysis of RESTOR-MV indicates that patients with FMR requiring revascularization treated with ventricular reshaping rather than standard surgery had improved survival and a significant decrease in major adverse outcomes. This trial validates the concept of the ventricular reshaping strategy in this subset of patients with heart failure. (Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve [RESTOR-MV]; NCT00120276)., (Published by Elsevier Inc. All rights reserved.)

Post-heart transplantation bradycardic syncope and arrest could be due to preferential rejection of the conduction system. We present six heart transplant patients with this presentation, two of whom died. The autopsy of one of those patients demonstrated severe rejection of the conduction system, with only mild rejection throughout the rest of the myocardium. We postulate that aggressive therapy for rejection and pacemaker placement may result in improved survival in heart transplant recipients with this clinical presentation.

Cardiac contractility modulation (CCM) signals are nonexcitatory electrical signals delivered during the cardiac absolute refractory period that enhance the strength of cardiac muscular contraction. Prior research in experimental and human heart failure has shown that CCM signals normalize phosphorylation of key proteins and expression of genes coding for proteins involved in regulation of calcium cycling and contraction. The results of prior clinical studies of CCM have supported its safety and efficacy. A large-scale clinical study, the FIX-HF-5 study, is currently underway to test the safety and efficacy of this treatment. In this article, we provide an overview of the system used to deliver CCM signals, the implant procedure, and the details and rationale of the FIX-HF-5 study design. Baseline characteristics for patients randomized in this trial are also presented.