17 research outputs found

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

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    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

    Undiagnosed aberrant right subclavian artery: pitfall in aortic arch surgery

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    Selected cerebral perfusion as brain protection via right subclavian artery during aortic arch aneurysm repair adds safety, but may be jeopardized by aortic arch anomalies not readily recognized preoperatively. We describe a case of transverse aortic arch aneurysm repair where an undiagnosed aberrant right subclavian artery was cannulated for selective brain protection

    Aortic arch replacement using a four-branched aortic arch graft

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    Surgical repair for aortic arch aneurysms is associated with considerable mortality and morbidity. Adequate brain protection is essential. Experience of aortic arch repair in six patients using a four-branched arch graft is described. There were two emergency and three reoperations. One patient had ruptured aneurysm. Hypothermic cardiopulmonary bypass (18-22 degrees C) was employed. A four-branched polymer albumin-coated arch graft was used. The fourth branch of the graft was used for secondary arterial cannulation to ensure continuous brain circulation. One hospital death occurred. No permanent neurological event occurred. The four-branched arch graft facilitates fashioning arch branch anastomoses and provides better brain protection

    Endovascular repair using vein-covered stents in the carotid artery bifurcation

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    The treatment of a bleeding carotid artery pseudoaneurysm in a patient using endovascular repair is described. Vein-covered stents were successfully employed. There were no neurological complications and no recurrent bleeding during 8 months follow up and carotid artery continuity was achieved. Stents covered with saphenous vein may be considered a treatment option for endovascular repair of pseudoaneurysm of the carotid artery

    Regional extra-corporeal circulation to protect transplanted kidney and pancreas from ischemia during vascular reconstruction

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    The development of severe aorto-ilio-femoral atherosclerotic disease in a patient with a previous double transplantation, kidney and pancreas, is a major surgical challenge. The transplanted organs have to be protected from extensive ischemia during the vascular reconstructive procedure and achieve optimal revascularization. The surgical management of a complex case where regional extra-corporeal circulation was used to protect transplanted pancreas and kidney during aorto-bifemoral vascular grafting in a 39 yr old diabetic patient is described. Regional femoro-femoral extra-corporeal circulation with an oxygenator is a safe technique that allows time for the proximal revascularization, minimizes the warm organ ischemia time and results in preservation of organ function

    Impact of Double Internal Thoracic Artery Grafts on Long-Term Outcomes in Coronary Artery Bypass Grafting

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    We performed this study to determine if bilateral internal thoracic artery grafts provide greater benefit than single internal thoracic artery grafts. Six hundred ninety-four consecutive patients who received 2 coronary grafts in a single operation during 1983–1989 were given 10 years of follow-up and then analyzed retrospectively. Group 1 (n=382) received 2 internal thoracic artery grafts, Group 2 (n=139) received 1 internal thoracic artery graft and 1 saphenous vein graft, and Group 3 (n=173) received 2 saphenous vein grafts. Patient demographics, preoperative angiographic findings, and operative indications were the same. Hospital mortality rates were 2.6%, 2.2%, and 2.3%, respectively. Hemorrhage, sternal wound infection, mediastinitis, sternal dehiscence, and prolonged ventilatory support showed no group differences. Follow-up over 10 years was complete in 677 survivors. Mortality rates during follow-up were 1.8%, 2.9%, and 4.7%, respectively. Cardiac-related mortality rates were 71%, 75%, and 88%, respectively (Group 1 vs Group 3, P=0.0412). Ten-year survival was better for Group 1 than for Groups 2 and 3 (P=0.0356 and P <0.0001). Cardiac-event-free survival at 10 years was 93% in Group 1, 84% in Group 2, and 74% in Group 3 (all P <0.0001). The use of 2 internal thoracic artery grafts resulted in significantly lower risk of cardiac death and re-intervention, compared with the use of 1 internal thoracic artery, which in turn was superior to the use of vein grafts. Use of double internal thoracic arteries did not increase postoperative complications
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