Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction, GALACTIC‐HF: baseline characteristics and comparison with contemporary clinical trials

Aims: The safety and efficacy of the novel selective cardiac myosin activator, omecamtiv mecarbil, in patients with heart failure with reduced ejection fraction (HFrEF) is tested in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC‐HF) trial. Here we describe the baseline characteristics of participants in GALACTIC‐HF and how these compare with other contemporary trials. Methods and Results: Adults with established HFrEF, New York Heart Association functional class (NYHA) ≥ II, EF ≤35%, elevated natriuretic peptides and either current hospitalization for HF or history of hospitalization/ emergency department visit for HF within a year were randomized to either placebo or omecamtiv mecarbil (pharmacokinetic‐guided dosing: 25, 37.5 or 50 mg bid). 8256 patients [male (79%), non‐white (22%), mean age 65 years] were enrolled with a mean EF 27%, ischemic etiology in 54%, NYHA II 53% and III/IV 47%, and median NT‐proBNP 1971 pg/mL. HF therapies at baseline were among the most effectively employed in contemporary HF trials. GALACTIC‐HF randomized patients representative of recent HF registries and trials with substantial numbers of patients also having characteristics understudied in previous trials including more from North America (n = 1386), enrolled as inpatients (n = 2084), systolic blood pressure < 100 mmHg (n = 1127), estimated glomerular filtration rate < 30 mL/min/1.73 m2 (n = 528), and treated with sacubitril‐valsartan at baseline (n = 1594). Conclusions: GALACTIC‐HF enrolled a well‐treated, high‐risk population from both inpatient and outpatient settings, which will provide a definitive evaluation of the efficacy and safety of this novel therapy, as well as informing its potential future implementation

SIMPLE, SAFE AND EASY TECHNIQUE TO ENSURE THE CORRECT LENGTH OF ARTIFICIAL CHORDAE IN MITRAL VALVE REPAIR.

Replacement of diseased chordae with Gore-Tex sutures (W. L. Gore & Assoc, Flagstaff, AZ) in patients with degenerative mitral valve insufficiency has become a standard technique used by surgeons in mitral valve repair with good long-term results. Nevertheless, determining the correct length of the artificial chordae has remained problematic. Although various procedures have been previously published, in this article we describe our approach used to achieve an accurate chordal height adjustment

inhaled prostacyclin,nitric oxyde and nitroprusside in pulmonary hypertension after mitral valve replacement

OBJECTIVE: Pulmonary hypertension increases morbidity and mortality in patients undergoing heart surgery. Mitral valve stenosis is frequently associated with an increase in pulmonary vascular resistance (PVR). Cardiopulmonary bypass exacerbates pulmonary hypertension in patients undergoing cardiac surgery. The aim of this study was to compare the hemodynamic effects of inhaled prostacyclin and nitric oxide and the administration of i.v. nitroprusside during cardiac surgery with a clinical, pharmacodynamic dose-response, prospective, randomized, and double-blind study (Group A: inhaled prostacyclin; Group B: inhaled nitric oxide; Group C: nitroprusside). MATERIALS AND METHODS: Fifty-eight patients with mitral valve stenosis and elevated PVR (>200 dynes sec/cm5) after mitral valve surgery were studied. Inhaled prostacyclin and nitric oxide were administered at concentrations of 10 g/min and 20 ppm, respectively. Nitroprusside i.v. was administered at the dose of 5-15 g/min. RESULTS: Prostacyclin and nitric oxide produced a significant dose-related decrease of mean pulmonary arterial pressure, pulmonary vascular resistance, and transpulmonary gradient. A significant increase in cardiac output was observed in both groups. In Group C, nitroprusside administration was interrupted in 62% patients due to occurrence of systemic hypotension. CONCLUSIONS: Inhaled prostacyclin and nitric oxide are effective in the treatment of postoperative pulmonary hypertension in patients with mitral valve stenosis undergoing mitral valve surgery. Both drugs improve cardiac output and reduce mean pulmonary arterial pressure, pulmonary vascular resistance, and trans-pulmonary gradient. They may be useful in patients with acute right ventricular failure following cardiac surgery. In comparison to nitric oxide, inhaled prostacyclin is free from toxic side effects and is easier to administer

Off-pump versus on-pump myocardial revascularization in patients with ST-segment elevation myocardial infarction: a randomized trial.

OBJECTIVE: Conventional cardioplegic arrest coronary artery bypass grafting after ST-segment elevation myocardial infarction is associated with high mortality and morbidity. The benefits of off-pump surgery have been suggested. This study randomly evaluated the impact of the off-pump technique on clinical results. METHODS: Between February 2002 and October 2007, 128 patients with ST-segment elevation myocardial infarction who underwent myocardial revascularization within 48 hours from the onset of symptoms were randomly assigned to 2 groups: on-pump group (66 patients/51.5%) and off-pump group (63 patients/48.5%). The primary end point was the incidence of in-hospital death and outcomes (low cardiac output syndrome, prolonged mechanical and pharmacologic cardiac support, prolonged mechanical ventilation support, and postoperative length of stay in intensive care unit and hospital). The secondary end point was the evaluation of myocardial infarct size measured by the perioperative serum release of cardiac troponin I and the improvement of contractile cardiac function evaluated by the wall motion score index. RESULTS: Overall in-hospital mortality was 4.6%. In-hospital mortality was 7.7% (5 patients) in the on-pump group and 1.6% (1 patient) in the off-pump group (P = .04). Statistically significant differences were found between the 2 groups concerning the incidence of low cardiac output syndrome (P = .001), time of inotrope drugs support (P = .001), time of mechanical ventilation (P = .006), reoperation for bleeding (P = .04), intensive care unit stay (P = .01), and in-hospital stay (P = .02). Statistically significant differences also were found between the 2 groups concerning the incidence of in-hospital death in patients who were admitted to surgery in cardiac shock (P = .0018) and patients who underwent surgery within 6 hours from the onset of symptoms (P = .0026). The procedure in 1 patient (1.6%) in the off-pump group was converted to the on-pump beating heart technique. The serum levels of cardiac troponin I were high in the on-pump group during the first 48 hours after surgery. Myocardial function was better in the off-pump group. There were no cardiac-related late deaths, and patients had no recurrent cardiac events. CONCLUSION: Off-pump surgery reduced early mortality and morbidity in patients with ST-segment elevation myocardial infarction in respect to the conventional procedure. Off-pump surgery showed better results than on-pump surgery in patients who underwent surgery within 6 hours from the onset of symptoms and in patients with cardiogenic shoc