Efficacy and safety of ECG-synchronized pulsatile extracorporeal membrane oxygenation in the clinical setting: The SynCor Trial.

INTRODUCTION: Mechanical circulatory support (MCS) devices are increasingly used as a treatment option in resuscitation or in patients with cardiogenic shock (CS). Prophylactic implantation in high-risk percutaneous coronary interventions (HRPCI) is another upcoming indication. The i-cor ECG-synchronized cardiac assist device combines the hemodynamic support of a veno-arterial extracorporeal membrane oxygenation (VA-ECMO) with the ability to generate a pulsatile flow and thus decreasing adverse effects of VA-ECMO on myocardial function. Aim of this study was to obtain data concerning feasibility, safety and outcomes in both indications. METHODS: A total of 47 patients (34 HRPCI, 13 CS) were included in nine German centers and participated in this study. Demographic and clinical parameters, procedural as well as follow-up data were prospectively recorded and analyzed. RESULTS: Device implantation and initiation of ECG-synchronized cardiac assist was technical successful in all cases and no failures of the consoles or disposable parts were observed. Furthermore, intended percutaneous coronary interventions and successful weaning from cardiac assist was achieved in 97.1% of HRPCI patients. We observed a 30d-survival of 94.1% in the HRPCI group and 69.2% in the CS group. Main complications in both groups were bleeding events (14.7% HRPCI, 23.1% CS) and critical limb ischemia (2.9% HRPCI, 38.5% CS). CONCLUSION: The i-cor ECG-synchronized cardiac assist device appears safe and feasible showing clinical outcomes comparable to existing data in the setting of high-risk percutaneous coronary interventions and acute cardiogenic shock. Further prospective trials are warranted to identify optimal patient and interventional characteristics that will benefit most of this novel kind of mechanical circulatory support.

[Myocardial infarction in a young patient with seminoma during chemotherapy with cisplatinum, etoposide, and bleomycin]. / Myokardinfarkt bei jungem Seminompatient während Chemotherapie mit Cisplatin, Etoposid und Bleomycin (PEB-Schema).

INTRODUCTION: More than 90 % of all patients with testicular germ cell tumours can be cured effectively. The mainstay of treatment is chemotherapy with cisplatin, etoposide and bleomycin (PEB). This regimen is usually well tolerated and does not lead to serious adverse events. Cardiovascular complications are encountered very rarely, but have gained increasing attention in recent years. CASE DESCRIPTION: A 33-year-old man with a testicular seminoma, clinical stage 2b, was subjected to PEB chemotherapy. At the end of the first treatment course, he had an acute ST-elevation myocardial infarction. Coronary angiography revealed a circumscribed stenosis of the left circumflex branch of the left coronary artery with intima dissection and thrombotic deposits. No atherosclerotic changes were found. Management consisted of placement of a drug-eluting coronary stent. Chemotherapy was discontinued and the seminoma treatment completed by radiotherapy with 30 Gy applied to the retroperitoneal mass and a paraaortic template. Complete remission was achieved. 6 months thereafter, the patient was doing well and was disease-free. COMMENT: About 0.3 % of all testis cancer patients undergoing cisplatin-based chemotherapy develop cardiovascular complications. Cisplatin-related endothelial damage with secondary thrombotic clotting is assumed to be etiologic in these cases. As there is little comorbidity, the prognostic outlook is favourable in most cases. Caregivers in charge of testis cancer management should be vigilant regarding cardiovascular complications to ensure immediate diagnostic and therapeutic measures in incident cases.

Aerobic training in adults after atrial switch procedure for transposition of the great arteries improves exercise capacity without impairing systemic right ventricular function.

BACKGROUND: Exercise training safely and efficiently improves symptoms in patients with heart failure due to left ventricular dysfunction. However, studies in congenital heart disease with systemic right ventricle are scarce and results are controversial. In a randomised controlled study we investigated the effect of aerobic exercise training on exercise capacity and systemic right ventricular function in adults with d-transposition of the great arteries after atrial redirection surgery (28.2 ± 3.0 years after Mustard procedure). METHODS: 48 patients (31 male, age 29.3 ± 3.4 years) were randomly allocated to 24 weeks of structured exercise training or usual care. Primary endpoint was the change in maximum oxygen uptake (peak VO2). Secondary endpoints were systemic right ventricular diameters determined by cardiac magnetic resonance imaging (CMR). Data were analysed per intention to treat analysis. RESULTS: At baseline peak VO2 was 25.5 ± 4.7 ml/kg/min in control and 24.0 ± 5 ml/kg/min in the training group (p=0.3). Training significantly improved exercise capacity (treatment effect for peak VO2 3.8 ml/kg/min, 95% CI: 1.8 to 5.7; p=0.001), work load (p=0.002), maximum exercise time (p=0.002), and NYHA class (p=0.046). Systemic ventricular function and volumes determined by CMR remained unchanged. None of the patients developed signs of cardiac decompensation or arrhythmias while on exercise training. CONCLUSIONS: Aerobic exercise training did not detrimentally affect systemic right ventricular function, but significantly improved exercise capacity and heart failure symptoms. Aerobic exercise training can be recommended for patients following atrial redirection surgery to improve exercise capacity and to lessen or prevent heart failure symptoms. ( CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov #NCT00837603).

Relation of diastolic and systolic function, exercise capacity and brain natriuretic peptide in adults after Mustard procedure for transposition of the great arteries.

OBJECTIVES: To evaluate the relation of echocardiographic parameters of diastolic function, exercise capacity (expressed as peakVO(2)) and NT-proBNP in patients with transposition of the great arteries (TGA) and Mustard procedure. METHODS: Diastolic function was determined by measuring tricuspid flow velocities (Ea/Aa ratio), isovolumic relaxation time (IVRT), and deceleration time (DT). E/Ea ratios were calculated. For assessment of systolic function, CMR was applied. RESULTS: E/A (r = 0.07, p = 0.66), E/Ea medial (r = 0.03, p = 0.84), E/Ea lateral (r = -0.01, p = 0.92), IVRT (r = -0.13, p = 0.44), and DT (r = -0.05, p = 0.76) were not correlated with peakVO(2). NT-proBNP showed a significant correlation with IVRT (r = 0.44, p = 0.004) and Ea/Aa medial (r = -0.34, p = 0.025). No correlation was found between RV systolic function and peakVO(2) (r = 0.07, p = 0.63). CONCLUSIONS: Exercise capacity in patients with TGA and Mustard procedure is not related to echocardiographic parameters of diastolic function. NT-proBNP is associated with selected echocardiographic parameters of diastolic function.

Diagnostic accuracy of handheld echocardiography for evaluation of aortic stenosis.

BACKGROUND: Symptomatic severe aortic stenosis is associated with increased mortality and morbidity. Early identification of these patients by echocardiography is crucial. We conducted this study to evaluate a handheld ultrasound device (HCU) in patients with suspected severe aortic stenosis (AS) in comparison to a standard echocardiography device (SE). METHODS: A HCU (Vivid I; GE Healthcare) and a SE device (Philips iE 33) were used to evaluate 50 consecutive patients with suspected severe AS. Two consecutive echocardiographic studies were performed by two experienced and blinded examiners using HCU and SE device. AS was graded by mean transaortic pressure, aortic valve area (AVA), and indexed AVA (AVA adjusted for body surface area). RESULTS: Mean difference for mean transaortic gradient, AVA and indexed AVA for the SE and HCU device were 1.28 mmHg (-0.70 to 3.26 mmHg), -0.02 cm(2) (-0.06 to 0.01 cm(2)), and -0.01 cm(2)/m(2) (-0.03 to 0.01 cm(2)/m(2)), respectively. Discrepancies between both devices were not associated with misinterpretation of the degree of AS. CONCLUSION: Our study demonstrates that HCU can be used to evaluate patients with suspected AS. (ECHOCARDIOGRAPHY 2010;27:481-486).

Hepatocyte gp130 deficiency reduces vascular remodeling after carotid artery ligation.

Inflammation and vascular remodeling are hallmarks of atherosclerosis, hypertension, and restenosis after angioplasty. Here we investigated the role of the hepatocyte gp130-dependent systemic acute phase response on vascular remodeling after carotid artery ligation. Mice with a hepatocyte-specific gp130 knockout on an apolipoprotein E(-/-) background (gp130-) were compared with control mice (gp130(flox)). Vascular remodeling was induced by permanent ligation of the left common carotid artery. This, in turn, activated the systemic acute phase reaction in gp130(flox) mice, as measured by serum amyloid A plasma levels, which was completely abrogated in gp130- mice (P<0.05). Morphometric analysis of the carotid artery revealed severe neointima formation and media thickening 28 days after ligation in gp130(flox) mice, which was suppressed in gp130- mice (P<0.01). Serial sections from gp130- carotid segments showed significantly less smooth muscle cell (SMC) proliferation and monocyte recruitment (P<0.01). To evaluate the impact of the gp130-dependent systemic acute phase response on SMCs, hepatocytes from gp130(flox) and gp130- mice were stimulated with interleukin 6. Interleukin 6-induced secretion of serum amyloid A was completely abolished in gp130- hepatocytes (P<0.01). Moreover, when stimulated with supernatants from gp130- hepatocytes, SMCs showed significantly less migration and proliferation compared with supernatants from gp130(flox) hepatocytes (P<0.01). Recombinant serum amyloid A induced SMC migration and proliferation (P<0.05) and serum amyloid A injection after carotid artery ligation restored vascular remodeling in gp130- mice (P<0.01). These results imply a critical role for the gp130-dependent systemic acute phase response for vascular inflammation and SMC migration, as well as proliferation, and, subsequently, for vascular remodeling.