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

Związek między stężeniem adiponektyny w surowicy i zwapnieniowym zwężeniem zastawki aortalnej

Background: Adiponectin, an adipose tissue derived cytokine, is known to have antiatherogenic and anti-inflammatory effectson endothelial cells and macrophages. Calcific aortic valve disease has a similar physiopathology to atherosclerosis.Aim: To investigate the relationship between adiponectin and calcific aortic valve disease.Methods: The study group consisted of 58 patients with calcific aortic stenosis and 24 healthy controls. Aortic stenosis patientswere divided into three groups according to their valvular areas: mild (n = 11), moderate (n = 25), and severe (n = 22).Serum adiponectin levels and other biochemical parameters were measured.Results: The aortic stenosis and control group were similar in terms of age, gender and cardiovascular risk factors. Adiponectinmedian values did not differ significantly between two groups (2.19 μg/mL [1.43–3.18], 1.79 μg/mL [1.34–3.42] aorticstenosis and control group, respectively; p = 0.7). Aortic stenosis patients were divided into three groups according to theirvalvular area as mild, moderate and severe. There were no differences when we compared adiponectin levels among thosegroups (mild: 2.10 μg/mL [1.47–3.31], moderate: 2.13 μg/mL [1.44–2.91], severe: 2.65 μg/mL [1.28–3.43]; p = 0.67). Age(r = 0.26, p = 0.045) and aspartate aminotransferase (r = 0.28, p = 0.04) had positive correlations with adiponectin; whilewhite blood cell count (r = –0.32, p = 0.015), fasting blood glucose (r = –0.29, p = 0.03), haemoglobin (r = –0.27, p = 0.04)and triglyceride levels (r = –0.41, p = 0.002) had negative correlations.Conclusions: In our study, we did not find a relationship between adiponectin levels and calcific aortic valve disease.Wstęp: Adiponektyna, cytokina produkowana przez tkankę tłuszczową, ma działanie przeciwmiażdżycowe i przeciwzapalnew stosunku do komórek śródbłonka i makrofagów. Zwapnienie zastawki aorty ma podobny patomechanizm jak miażdżyca.Cel: Celem niniejszej pracy było zbadanie zależności między stężeniem adiponektyny a stopniem zwapnieniowego zwężeniaaorty.Metody: Do badania włączono 58 chorych ze zwapnieniowym zwężeniem aorty i 24 zdrowe osoby stanowiące grupę kontrolną.Chorych ze stenozą aortalną podzielono na 3 grupy w zależności od stopnia zwężenia: osoby z łagodnym (n = 11),umiarkowanym (25) i ciężkim (n = 22) zwężeniem zastawki aortalnej. U wszystkich uczestników badania zmierzono stężenieadiponektyny w surowicy oraz inne parametry biochemiczne.Wyniki: Rozkład wieku, płci i czynników ryzyka sercowo-naczyniowego był podobny w grupie ze stenozą aortalną i w grupiekontrolnej. Porównanie mediany stężenia adiponektyny również nie wykazało istotnej różnicy między grupami [odpowiednio2,19 μg/ml (1,43–3,18); 1,79 μg/ml (1,34–3,42); p = 0,7]. Chorych ze stenozą aortalną podzielono na trzy grupy — z lekkim,umiarkowanym lub ciężkim zwężeniem — w zależności od pola powierzchni ujścia zastawki. Nie stwierdzono różnic, porównującstężenia adiponektyny w tych trzech grupach [łagodne zwężenie: 2,10 μg/ml (1,47–3,31), umiarkowane: 2,13 μg/ml(1,44–2,91), ciężkie: 2,65 μg/ml (1,28–3,43); p = 0,67]. Wiek (r = 0,26; p = 0,045) i stężenie aminotransferazy asparaginianowej(r = 0,28; p = 0,04) korelowały dodatnio ze stężeniem adiponektyny, natomiast w przypadku liczby krwinekbiałych (r = –0,32; p = 0,015), glikemii na czczo (r = –0,29; p = 0,03) oraz stężenia hemoglobiny (r = –0,27; p = 0,04)i triglicerydów (r = –0,41; p = 0,002) wykazano korelację ujemną.Wnioski: W niniejszym badaniu nie wykazano związku stężenia adiponektyny z zwapnieniowym zwężeniem aorty ani zestopniem zwężenia

Extraction of a large vegetation and ICD lead using the Evolution Mechanical Dilator Sheath

A 74-year-old male patient presented with complaints of fatigue, fever, and worsening health status. He had a 34-month history of cardioverter- defibrillator (ICD) implantation due to ischemic cardiomyopathy. Transthoracic and transesophageal echocardiography showed a mobile mass, 24x11 mm in size, consistent with a vegetation attached to the right ventricular ICD lead. Surgical removal of the electrode was considered to be highly risky for the patient, thus percutaneous removal was decided. Due to adhesions, manual traction of the lead with a standard stylet was ineffective. Complete lead extraction was accomplished using the Evolution Mechanical Dilator Sheath, which is a new mechanical sheath with a stainless steel bladed tip. No complications occurred during or after the procedure. Following a histopathologic diagnosis of vegetation, the patient received a six- week antibiotic therapy, after which a new ICD was implanted on the contralateral side. To our knowledge, this case represents the largest lead vegetation extracted by this new device. Although its safety should be validated by increasing number of cases, it seems that its simple use would make this device a new interesting tool among the instruments available for lead extraction