Efficacy and Safety of Esaxerenone in Hypertensive Patients with Left Ventricular Hypertrophy (ESES-LVH) Study: A Multicenter, Open-Label, Prospective, Interventional Study.

INTRODUCTION: In contrast to the antihypertensive effect of esaxerenone, there is little evidence of its cardioprotective effect. We investigated the efficacy and safety of esaxerenone in patients with uncontrolled hypertension and left ventricular hypertrophy taking a renin-angiotensin system inhibitor (RASi) or calcium-channel blocker (CCB). METHODS: This was a multicenter, open-label, exploratory study with a 24-week treatment period. Esaxerenone was orally administered at an initial dose of 2.5 mg/day (maximum dose: 5 mg/day). The primary endpoints were the change in morning home systolic blood pressure (BP)/diastolic BP and change and percentage change in left ventricular mass index (LVMI) from baseline to end of treatment (EOT). Key secondary endpoints included change from baseline in bedtime home and office BP, achievement rate of target BP, and safety. RESULTS: In total, 60 patients were enrolled. Morning home systolic/diastolic BP was significantly decreased from baseline to EOT in the total population (- 11.5/ - 4.7 mmHg, p < 0.001) and in both the RASi and CCB subcohorts (all p < 0.01). Significant reductions in bedtime home and office BP were shown in the total population and both subcohorts. LVMI was also significantly decreased from baseline to EOT in the total population (- 9.9 g/m2, - 8.5%, both p < 0.001) and both subcohorts (all p < 0.05). The incidences of treatment-emergent adverse events (TEAEs) and drug-related TEAEs were 35.0% and 3.3%, respectively; most were mild or moderate. No new safety concerns were identified. CONCLUSION: Esaxerenone showed favorable antihypertensive and cardioprotective effects and safety in hypertensive patients with cardiac hypertrophy. TRIAL REGISTRATION: Japan Registry of Clinical Trials (jRCTs071190043).

Pneumopericardium suggesting left ventricular assist device-related gastrointestinal complication.

We report an uncommon case of ventricular assist device-related infection and resultant fistula formation into the gastrointestinal tract. A 69-year-old man, who had undergone implantation of a HeartMate II 1 year earlier secondary to ischemic cardiomyopathy, presented to our hospital with a high fever. Computed tomography showed unusual gas collection around the heart apex (i.e., pneumopericardium), which had not been detected before. The patient developed sudden melena with fresh blood without abdominal symptoms 1 month after beginning antibiotic therapy. Emergent colonoscopy showed that the HeartMate II strain relief of the inflow conduit had penetrated the transverse colon. We immediately performed laparoscopy-assisted left-sided hemicolectomy and found intraoperatively that a fistula had formed between the splenic flexure and the pericardial cavity. Subsequently, the HeartMate II system was totally explanted and replaced with an Impella 5.0 for alternative hemodynamic support. In our patient, pneumopericardium might have been an early sign of a hidden gastrointestinal complication. Our experience is a caution for clinicians who manage patients with ventricular assist device support via the apex.

[Congenitally Corrected Transposition of the Great Arteries( TGA) in Adult].

OBJECTIVES: In patients with congenitally corrected transposition of the great arteries( cc-TGA), the morphological right ventricle (RV) sustains the systemic circulation and is frequently associated with progressive tricuspid regurgitation and declining RV function. METHODS: Thirty-four patients with cc-TGA and systemic RV were enrolled in this retrospective study to examine long-term outcome. RESULTS: Age was averaged 38.5 years. Associated cardiac anomaly included ventricular septal defect (VSD) and pulmonary stenosis in 18, VSD in 4. Twelve had no associated cardiac defect. The physiologic repair was performed in 22 patients at the mean age of 7.8 years old. Reoperation was frequent including tricuspid valve surgery in 11 and left ventricle( LV)-pulmonary artery( PA) conduit replacement in 10. Five patients needed pacemaker implantation due to heart block. Aortic insufficiency was a relatively common finding and aortic valve replacement was performed in 4. All but 2 patients were better than New York Heart Association (NYHA) class Ⅱ. One needed implantable ventricular assist device implantation and the other underwent heart transplantation. CONCLUSIONS: Long-term outcome for patients with cc-TGA was satisfactory. Frequent reoperations including tricuspid valve surgery and LV-PA conduit replacement were required. Further careful follow-up will be needed to detect the progression of RV dysfunction and tricuspid and aortic insufficiency.

Thoracic endografting increases cardiac afterload and leads to left ventricular hypertrophy in dogs.

OBJECTIVES: Aortic endografting can cause aortic stiffening. We aimed to determine the chronic effect of thoracic endografting on cardiac afterload, function and remodelling. METHODS: Eleven dogs were included, and all except 1 was successfully assessed [endograft, n = 5; sham operation (control), n = 5]. We deployed a stent graft in the descending aorta. The ascending aortic pressure and flow were measured, and aortic input impedance was obtained by frequency analysis to determine characteristic impedance and arterial compliance. Left ventricular pressure-volume relations were measured with an admittance catheter. Measurements were performed before, 10 min after and 3 months after endografting. Following euthanasia, we weighed the left ventricle of each dog and measured the cardiomyocyte cell size. RESULTS: Arterial compliance decreased from 0.47 ± 0.07 to 0.36 ± 0.06 and to 0.31 ± 0.05 ml/mmHg (both P < 0.01 versus baseline), and characteristic impedance increased from 0.11 ± 0.04 to 0.19 ± 0.05 and to 0.21 ± 0.04 mmHg/ml/s (both P < 0.01 versus baseline) 10 min and 3 months after endografting, respectively. Pressure-volume relation analysis showed that arterial elastance increased from 5.3 ± 1.0 to 6.7 ± 1.6 (at 10 min) and to 6.8 ± 1.0 mmHg/ml (at 3 months) (both P < 0.05 versus baseline), but end-systolic elastance and ventriculo-arterial coupling remained unchanged. Left ventricular weight to body weight ratio and left ventricular cardiomyocyte cell width in the endograft group were larger compared with the control's results (5.06 ± 0.27 g/kg vs 4.20 ± 0.49 g/kg, P = 0.009, 15.1 ± 1.7 µm vs 13.9 ± 1.5 µm, P = 0.02, respectively). CONCLUSIONS: The mid-term effect of the descending aortic endografting on left ventricular contractility and efficiency in canine normal hearts was minimal. However, endografting resulted in increased cardiac afterload and left ventricular hypertrophy.

Bronchial Artery Aneurysm Treated Using Aortic Stent Graft Alone: A Case Report.

A 72-year-old woman with a history of malignant lymphoma was referred to our hospital for the treatment of a bronchial artery aneurysm. Computed tomography (CT) scan showed a round, 30 mm-diameter fusiform aneurysm with two tortuous inflow arteries. We deployed thoracic stent grafting to cover the orifice of the two inflow arteries without transcatheter bronchial arterial embolization. Postoperative CT scan revealed complete thrombosis of the aneurysm. Although further follow-up is mandatory, this may be considered a viable treatment option in cases wherein the bronchial artery aneurysm is anatomically difficult to treat.

Impact of bilateral superior venae cavae on outcome of staged Fontan procedure.

BACKGROUND: The presence of bilateral superior venae cavae may add complexity to the performance of a bidirectional Glenn procedure (BDG). Stagnation of blood flow between the two cavopulmonary anastomoses may increase the risk of thrombosis and impair central pulmonary artery growth. METHODS: Forty patients underwent BDG from January 2004 to April 2011. The cohort was divided into two groups: those receiving bilateral BDG (b-BDG, n = 13) and those receiving unilateral BDG (u-BDG, n = 27). Operative, angiographic, and follow-up data were analyzed retrospectively. RESULTS: None of the patients experienced thrombosis. There was no difference in actuarial survival rate (u-BDG vs b-BDG, 100% vs 92% at 5 years, p = 0.15). On follow-up angiography, no difference in central pulmonary artery index was noted (78.4 ± 45.5 vs 60.4 ± 32.1, p = 0.24). Central pulmonary artery stenosis was detected in 6 patients (4 with u-BDG and 2 with b-BDG), 4 of whom (2 from each group) underwent balloon pulmonary artery plasty before the Fontan procedure. There was no difference in freedom from reintervention for central pulmonary artery stenosis (93% vs 85% at 1 year, p = 0.59). The rate of Fontan completion was comparable between groups, with similar operative variables and satisfactory outcomes. CONCLUSIONS: Bilateral BDG did not increase the risks of thrombosis and central pulmonary artery hypoplasia and can be performed safely without altering the outcome of the Fontan procedure.

A case of conversion of a NIPRO ventricular assist system to an EVAHEART left ventricular assist system.

Bridge to bridge (BTB) is a promising strategy for the treatment of end-stage heart failure that involves the left ventricular assist system (LVAS). We describe our experience with the conversion of an extracorporeal ventricular assist system (VAS), the NIPRO VAS, to an implantable LVAS, the EVAHEART LVAS. A 32-year-old man underwent a NIPRO VAS implantation as a bridge to decision for a condition consistent with Interagency Registry for Mechanically Assisted Circulatory Support profile 1. He was later diagnosed with secondary cardiomyopathy due to cardiac sarcoidosis. During the period in which he had NIPRO VAS support, no significant bacterial cultures were obtained from the cannula-piercing site, and no systemic infection occurred. Approximately 5 months after the NIPRO VAS implantation, he underwent an EVAHEART LVAS implantation as a BTB. The procedure required technical modifications, including the anastomosis of outflow grafts, trimming of the apical cuff, and creation of a pump pocket. The operation was completed uneventfully. The patient completed the discharge program for awaiting heart transplantation at home. Approximately 6 months after the EVAHEART LVAS implantation, he continues to do well without any complications, including infection, and visits our hospital as an outpatient. Conversion to an implantable LVAS can be beneficial in carefully selected patients after ascertaining the operative indications and operation timing.