The European Registry for Patients with Mechanical Circulatory Support (EUROMACS) of the European Association for Cardio-Thoracic Surgery (EACTS): second report.

OBJECTIVES: The European Registry for Patients with Mechanical Circulatory Support (EUROMACS) was founded in Berlin, Germany. EUROMACS is supported fully by the European Association for Cardio-Thoracic Surgery (EACTS) and, since 2014, has functioned as a committee of the EACTS. The purpose of having the EUROMACS as a part of the EACTS is to accumulate clinical data related to long-term mechanical circulatory support for scientific purposes and to publish annual reports. METHODS: Participating hospitals contributed surgical and cardiological pre-, peri- and long-term postoperative data of mechanical circulatory support implants to the registry. Data for all implants performed from 1 January 2011 to 31 December 2016 were analysed. Several auditing methods were used to monitor the quality of the data. Data could be provided for in-depth studies, and custom data could be provided at the request of clinicians and scientists. This report includes updates of patient characteristics, implant frequency, mortality rates and adverse events. RESULTS: Fifty-two hospitals participated in the registry. This report is based on 2947 registered implants in 2681 patients. Survival of adult patients (>17 years of age) with continuous-flow left ventricular assist devices with a mean follow-up of 391 days was 69% (95% confidence interval 66-71%) 1 year after implantation. On average, patients were observed for 12 months (median 7 months, range 0-70 months). When we investigated for adverse events, we found an overall event rate per 100 patient-months of 3.56 for device malfunction, 6.45 for major bleeding, 6.18 for major infection and 3.03 for neurological events within the first 3 months after implantation. CONCLUSIONS: Compared to the first EUROMACS report, the number of participating hospitals increased from 21 to 52 (+148%), whereas the number of registered implants more than tripled from 825 to 2947 (+257%). The increase in the number of participating hospitals led us to increase the quality control measures through data input control, on-site audits and statistical analyses.

Post-traumatic ventricular septal defect: a rare indication for extracorporeal membrane oxygenation as a bridge to transplant.

A ventricular septal defect (VSD) is a rare complication of blunt chest trauma. This report presents the case of a 44-year-old man who developed a VSD as a result of high-energy closed chest trauma. We describe the initial surgical and medical management of the cardiac rupture. After failed repair surgery, extracorporeal membrane oxygenation (ECMO) was used as a bridge to heart transplantation. We discuss the successful use of ECMO to improve the prognosis results in this rare and complex entity.

Usefulness of Two-Dimensional Strain Parameters to Diagnose Acute Rejection after Heart Transplantation.

BACKGROUND: Acute cellular rejection (ACR) is still a relevant complication after orthotopic heart transplantation. The diagnosis of ACR is based on endomyocardial biopsy (EMB). Recent advances in two-dimensional strain imaging may allow early noninvasive detection of ACR. The objective of this study was to analyze the usefulness of conventional and new echocardiographic parameters to exclude ACR after orthotopic heart transplantation. METHODS: Thirty-four consecutive adult heart transplant recipients admitted to a single center between January 2010 and December 2012 for orthotopic heart transplantation were prospectively included. A total of 235 pairs of EMB and echocardiographic examination were performed. A median of seven studies per patient (interquartile range, six to eight studies per patient) were performed during the first year of follow-up. Classic echocardiographic parameters; speckle-tracking-derived left ventricular (LV) longitudinal, radial, and circumferential strain; and global and free wall right ventricular (RV) longitudinal strain were analyzed. RESULTS: ACR was detected in 26.4% of EMB samples (n = 62); 5.1% (n = 12) required specific treatment (ACR degree ≥ 2R). Lower absolute values of global LV longitudinal strain and free wall RV longitudinal strain were present in patients with ACR degree ≥ 2R compared with those without ACR (13.7 ± 2.7% vs 17.8 ± 3.4% and 16.6 ± 3.6% vs 23.3 ± 5.2%, respectively). An average LV longitudinal strain < 15.5% had 85.7% sensitivity, 81.4% specificity, 98.8% negative predictive value, 25.0% positive predictive value, and 81.7% accuracy for the presence of ACR degree ≥ 2R. Free wall RV longitudinal strain < 17% had 85.7% sensitivity, 91.1% specificity, 98.8% negative predictive value, 42.9% positive predictive value, and 90.7% accuracy for ACR degree ≥ 2R. Both variables were normal in 106 echocardiograms (57.6%); none of these patients presented with ACR degree ≥ 2R. CONCLUSIONS: The combination of two new echocardiographic measures, global LV and RV free wall longitudinal strain, may be able to identify a group of heart transplant patients who are unlikely to have ACR. If these findings are confirmed independently, it may be possible to use LV and RV strain measures as reliable tools to exclude ACR and to reduce the burden of repeated EMB.

Characteristics of patients with survival longer than 20 years following heart transplantation.

INTRODUCTION AND OBJECTIVES: The number of heart-transplant recipients exceeding 20 years of follow-up is steadily increasing. However, little is known about their functional status, comorbidities, and mortality. Identifying the predictors of prolonged survival could guide the selection of candidates for the low number of available donors. METHODS: Functional status, morbidities, and mortality of heart-transplant patients between 1984 and 1992 were analyzed. To identify predictors of 20-year survival, a logistic regression model was constructed using the covariates associated with survival in the univariate analysis. RESULTS: A total of 39 patients who survived 20 years (26% of patients transplanted before 1992) were compared to 90 recipients from the same period who died between 1 and 20 years post-transplantation. Major complications were hypertension, renal dysfunction, infections, and cancer. After a mean follow-up of 30 months, 6 survivors had died, yielding a mortality rate of 6% per year (vs 2.5%-3% in years 1-19). Causes of mortality were infection (50%), malignancy (33%), and allograft vasculopathy (17%). Long-term survivors were younger and leaner, and had nonischemic cardiomyopathy and lower ischemic time. Logistic regression identified recipient age <45 years (odds ratio=3.9; 95% confidence interval, 1.6-9.7; P=.002) and idiopathic cardiomyopathy (odds ratio=3; 95% confidence interval, 1.4-7.8; P=.012) as independent predictors for 20-year survival. CONCLUSIONS: One fourth of all heart-transplant patients in our series survived >20 years with the same graft, and most enjoy independent lives despite significant comorbidities. Recipient age <45 years and idiopathic cardiomyopathy were associated with survival beyond 2 decades. These data may help decide donor allocation.

RADIAL: a novel primary graft failure risk score in heart transplantation.

BACKGROUND: Primary graft failure (PGF) is the leading cause of early mortality after heart transplantation (HT). Our aim is to propose a working definition of PGF and to develop a predictive risk score. METHODS: PGF was defined by four criteria reflecting significant myocardial dysfunction, severe hemodynamic impairment, early onset after HT, and absence of secondary causes of graft dysfunction. We identified independent risk factors for PGF in a derivation series of 621 HTs and constructed a predictive model. After proving its internal consistency we tested the model in a prospective validation series. RESULTS: The incidence and lethality of PGF in our series were 9% and 80%, respectively. We identified 6 multivariate risk factors for PGF (Right atrial pressure ≥ 10 mm Hg, recipient Age ≥ 60 years, Diabetes mellitus, Inotrope dependence, donor Age ≥ 30 years, Length of ischemic time ≥ 240 minutes--i.e., RADIAL). Analysis of isolated right ventricular failure showed similar predictors. The RADIAL score was obtained by adding 1 point for each of these factors present in a given HT. PGF incidence increased significantly as the RADIAL score increased (p < 0.001 for trend). Rates of actual and predicted PGF incidence for RADIAL subgroups showed a good correlation (C-statistic = 0.74). In a prospective validation cohort, RADIAL score kept its predictive ability. CONCLUSIONS: PGF as defined by these criteria showed a high impact on early post-HT mortality in our series. The RADIAL score showed good ability to predict the development of PGF, and could be useful in the prevention and early treatment of this complication.

Apoptosis and acute cellular rejection in human heart transplants.

INTRODUCTION AND OBJECTIVES: Apoptosis has been implicated in the pathophysiology of various forms of heart disease. Acute cellular rejection leads to morbidity after heart transplantation and invasive techniques are needed for its diagnosis. We investigated the presence of cardiomyocyte apoptosis in transplanted hearts, its progression, its relationship with rejection, and the possibility that serological markers of apoptosis can be used to detect rejection noninvasively. METHODS: Overall, 130 endomyocardial biopsies obtained sequentially from 14 consecutive patients during the first 6 months following heart transplantation underwent histochemical analysis. The degree of acute rejection was determined, myocyte apoptosis was assessed using the TUNEL method, and caspase-3 activity was measured. In the first 10 patients, soluble Fas, tumor necrosis factor-alpha (TNFα) and interleukin 6 levels were determined in serum collected at biopsy. RESULTS: Apoptotic cells were detected in 81.5% of biopsies. No significant correlation was found between the apoptotic index and either the degree of rejection or the time from transplantation; there was only a trend to higher values during prolonged episodes of rejection, which did not reach statistical significance. An inverse correlation was observed between the degree of rejection and the TNFα level (rs=-0.33; P=.003). There was no correlation with any other variable. CONCLUSIONS: Cardiomyocyte loss due to apoptosis was observed in transplanted hearts, but no correlation was observed with either acute rejection or the time from transplantation. Our findings suggest there could be an inverse correlation between rejection and the serum TNFα level. No serum parameter evaluated was regarded as suitable for the noninvasive diagnosis of acute rejection.

Failure of percutaneous closure of prosthetic, aortic paravalvular leak.

We report the progression of aortic insufficiency after percutaneous closure of an aortic prosthesis paravalvular leak with the Amplatzer vascular plug (AGA Inc, Golden Valley, MN). Removal of the device and replacement of the aortic prosthesis was successfully performed. Based on operative findings, we hypothesize that shape mismatch between the occluder system and the leak might promote tearing at the end of slanted defects further enhancing the regurgitant area.

Influence of hypothermia on right atrial cardiomyocyte apoptosis in patients undergoing aortic valve replacement.

BACKGROUND: There is increasing evidence that programmed cell death can be triggered during cardiopulmonary bypass (CPB) and may be involved in postoperative complications. The purpose of this study was to investigate whether apoptosis occurs during aortic valve surgery and whether modifying temperature during CPB has any influence on cardiomyocyte apoptotic death rate. METHODS: 20 patients undergoing elective aortic valve replacement for aortic stenosis were randomly assigned to either moderate hypothermic (ModHT group, n = 10, 28 degrees C) or mild hypothermic (MiHT group, n = 10, 34 degrees C) CPB. Myocardial samples were obtained from the right atrium before and after weaning from CPB. Specimens were examined for apoptosis by flow cytometry analysis of annexin V-propidium iodide (PI) and Fas death receptor staining. RESULTS: In the ModHT group, non apoptotic non necrotic cells (annexin negative, PI negative) decreased after CPB, while early apoptotic (annexin positive, PI negative) and late apoptotic or necrotic (PI positive) cells increased. In contrast, no change in the different cell populations was observed over time in the MiHT group. Fas expression rose after reperfusion in the ModHT group but not in MiHT patients, in which there was even a trend for a lower Fas staining after CPB (p = 0.08). In ModHT patients, a prolonged ischemic time tended to induce a higher increase of Fas (p = 0.061). CONCLUSION: Our data suggest that apoptosis signal cascade is activated at early stages during aortic valve replacement under ModHT CPB. This apoptosis induction can effectively be attenuated by a more normothermic procedure.

[Ischemia-reperfusion injury during experimental heart transplantation. Evaluation of trimetazidine's cytoprotective effect]. / Daño por isquemia-reperfusión durante el trasplante cardíaco experimental. Evaluación del papel citoprotector de la trimetazidina.

INTRODUCTION AND OBJECTIVES: The objectives of this study were to analyze the ischemia-reperfusion injury due to free radicals that occurs during heart transplantation and to determine the potential cytoprotective effect of trimetazidine. MATERIAL AND METHOD: A total of 21 orthotopic heart transplantations were performed in pigs. We divided the experimental animals into 2 groups: in group A (n=11),standard myocardial protection was used; in group B (n=10), trimetazidine was added to the cardioplegic solution used to protect the donor heart and to the solution administered to the recipient prior to release of the aortic clamp (trimetazidine, 10(-5) mol/L), and recipients were pretreated with trimetazidine, 2.5 mg/kg. Blood samples were taken from the recipients coronary sinus at three times: at baseline, during ischemia, and during reperfusion. We measured the levels of malondialdehyde, a marker of lipid peroxidation, and of several antioxidants: glutathione peroxidase, glutathione reductase, superoxide dismutase, alpha-tocopherol, and retinol. The total antioxidant status was also determined. RESULTS: Malondialdehyde production and enzymatic antioxidant activity rose during ischemia and reperfusion, while the retinol level decreased. The increases in malondialdehyde level and glutathione peroxidase activity that occurred between baseline and reperfusion were significantly higher in group A. CONCLUSIONS. The degree of lipid peroxidation and the level of activity of intracellular antioxidant mechanisms increased progressively throughout transplantation. Trimetazidine had a cytoprotective effect. It ameliorated free radical-induced reperfusion injury and modified the response pattern of several defense mechanisms.

[Valve repair for chronic mitral regurgitation]. / Reparación valvular en la insuficiencia mitral crónica.

Valve repair is the best surgical treatment for mitral regurgitation. In the present article we describe the results of mitral valve repair in patients with chronic mitral regurgitation treated at our center during the last eight years. The degree of correction of valve insufficiency, functional benefit, in-hospital morbidity and mortality, postoperative outcome of ventricular function, and middle-term overall and reoperation-free survival are analyzed.

[Surgical treatment for hypertrophic obstructive cardiomyopathy]. / Tratamiento quirúrgico de la miocardiopatía hipertrófica obstructiva.

INTRODUCTION AND OBJECTIVES: Five percent of the patients with hypertrophic obstructive cardiomyopathy (HOCM) have symptoms unresponsive to medical treatment and are candidates for invasive therapy. The objective of this study was to analyze our results with surgical treatment of HOCM during the last 10 years. PATIENTS AND METHOD: Between July 1993 and January 2004 26 patients with HOCM refractory to drug therapy were operated on. An extended septal myectomy was performed, in combination with anterior mitral leaflet plication in 19 cases (73%) and with mitral valve replacement in 5 (19%). Evolution of the grade of dyspnea, left ventricle outflow tract gradient (LVOTG), mitral regurgitation, and systolic anterior motion after surgery was analyzed. RESULTS: Mean follow-up was 63 (37) months. After surgery, a significant reduction in LVOTG (from 96.5 to 19.5 mmHg; P<.001), grade of mitral regurgitation (from 2.54 to 0.69; P<.001) and systolic anterior motion (from 2.92 to 0.23; P<.001) was achieved, which led to improvement in functional class. Hospital mortality and need for pacemaker implantation due to complete heart block after surgery was 3.8% (n=1). There were no cases of iatrogenic ventricular septal defect or mitro-aortic valve injury. Actuarial survival at 5 years was 96% (4%). CONCLUSIONS: Surgery in patients with HOCM yields great clinical improvements with low morbidity and mortality. Simultaneous intervention for both myocardial and valvular components of the disease allows not only reduction in the LVOTG but also correction of mitral regurgitation and abolition of systolic anterior motion.

[Right atrial pheochromocytoma]. / Feocromocitoma de aurícula derecha.

Pheochromocytoma is a catecholamine-producing tumor and a rare cause of hypertension. Most cases are intra-adrenal and intrapericardial pheochromocytomas are extremely uncommon. We report the case of a 46-year-old woman with a 1-year history of hypertension, in which a right atrial pheochromocytoma was detected after a hypertensive crisis. 131I-metaiodobenzylguanidine scintigraphy and magnetic resonance imaging established the diagnosis. The tumor was successfully resected using cardiopulmonary bypass and the right atrium was reconstructed using bovine pericardium.

Edge-to-Edge tricuspid repair for redeveloped valve incompetence after DeVega's annuloplasty.

"Edge-to-edge" technique is a well-accepted procedure with excellent results for correction of mitral insufficiency. We describe a simple edge-to-edge combined with bicuspidalization repair method that was successfully applied in 2 patients for the treatment of redeveloped functional tricuspid regurgitation after previous annuloplasty. Significant improvement in symptoms and echocardiographic results were achieved.