Complication profile of the Berlin Heart EXCOR biventricular support in children.

In chronic cardiomyopathy, mechanical circulatory support (MCS) plays an increasingly important role for children as the shortage of suitable donor hearts increases waiting time on the transplant list. We report our experience with the paracorporal Berlin Heart EXCOR System (Berlin Heart AG, Berlin, Germany) used as a biventricuclar assist device (BVAD). Nine patients with a BVAD EXCOR system were treated between 2006 and 2012; out of these patients, four were less than 18 years old (6, 14, 14, and 17 years old). Their diagnoses were postcardotomy failure (n = 1), dilatative cardiomyopathy (n = 2), and terminal heart failure (n = 1). Overall survival, waiting time for heart transplantation (HTx) and complication profile for the BVAD were analyzed retrospectively. Thirty days' mortality was 25% (n = 1). One child died after 84 days on support due to cerebral bleeding. Mean support time was 218.75 days (4, 84, 262, and 525 days). Pump chamber exchange was necessary three times due to pump chamber thrombosis (n = 2) and partial pump chamber membrane rupture (n = 1). Complications included: sepsis (n = 1), drive line infection requiring intravenous antibiotics (n = 2), and recurrent epistaxis (n = 3). Two children were successfully transplanted after 262/525 days on BVAD; they are currently at home (follow-up: 1.9 and 2.3 years). The EXCOR is a life-saving MCS system suitable for long-term paracorporeal biventricular assistance.

Prehospital care of left ventricular assist device patients by emergency medical services.

Left ventricular assist devices (LVADs) are frequently implanted as permanent (bridge to destination [BTD]) or temporary (bridge to transplantation [BTT]) cardiac support. When LVAD patients are discharged to home, they are very likely to require emergency medical services (EMS), but there is very little literature on out-of-hospital emergency care for patients with LVADs. We present two typical cases of LVAD patients for whom EMS was called. In the first case, the patient was in an ambulance two hours distant from our university hospital when a pulsatile system malfunctioned. In the second case, EMS was called to an unconscious LVAD patient. Emergency reference cards, training programs for emergency medical staff, and a 24-hour emergency hotline for the local VAD team are advisable.

Everolimus in different combinations as maintenance immunosuppressive therapy in heart transplant recipients.

OBJECTIVES: We examined the experiences of heart transplant recipients receiving everolimus as maintenance therapy in different combinations over a long time. MATERIALS AND METHODS: Between 2004 and 2009, forty patients (29 men, 11 women; mean age, 51.6 y) were switched from a routine immunosuppressive regimen to everolimus. Indications were other (2), renal insufficiency (17), cardiac allograft vasculopathy (14), and ongoing cellular rejection (7). Combinations were either along with cyclosporine (24), mycophenolate mofetil (14), or others (2). Indications for the introduction of everolimus including safety, efficacy, different combinations of everolimus, biopsy-proven acute rejections, renal function, and infections were evaluated retrospectively. RESULTS: Five patients died, 4 of them were still on everolimus at the time of death; they died from intracerebral hemorrhage (1), embolism (1), cardiac arrest (2), and unknown (1). Everolimus was discontinued in 6 patients owing to severe adverse effects: Edema (2), gastrointestinal adverse effects (3), and dermal adverse effects (1). Mean everolimus trough levels were 5.8 µmol/L at 6 months and 4.9 at 60 months. Mean cyclosporine levels were 67.62 µmol/L at 6 months and 47.3 µmol/L at 60 months. Mean serum creatinine levels were stable (147.9 µmol/L after 60 months). Four life-threatening infections (all pneumonia) occurred but resulted in complete recovery. CONCLUSIONS: Everolimus is safe with different immunosuppressive combinations after receiving a heart transplant.

Everolimus and reduced cyclosporine trough levels in maintenance heart transplant recipients.

BACKGROUND: Long-term survival of patients after oHTX significantly increased over the last years, but CAV and chronic renal failure due to nephrotoxic side-effects of CNIs still remain unsolved problems. Everolimus has shown to reduce acute cellular rejection and may allow CsA dosage reduction. In this study the effectiveness of Everolimus in combination with CsA dosage reduction in maintenance oHTX immunosuppression and the influence on renal function was tested. METHODS: 37 patients (30 male, 7 female) after oHTX were divided into group A (n = 20) receiving Everolimus in combination with CsA and prednisolone and group B (n = 17) under standard immunosuppression with CsA, MMF and prednisolone. Patients received 1.0 mg to 1.5 mg Everolimus per day and target Everolimus trough levels were between 3 and 8 ng/ml. Death, safety, side effects, BPAR, trough levels, and routine laboratory values especially creatinine levels were monitored over a follow-up period of 8 months retrospectively and statistically evaluated. RESULTS: A significant reduction of CsA dosage (p < 0.001) and a significant CsA trough level reduction (p < 0.001) to a median CsA trough level of 68.5 ng/ml were achieved in group A. Mean Everolimus trough levels were reached within 1 week and 2 months. Renal function was stable in both groups. No statistical differences in BPAR, hospitalization rates or triglyceride levels were observed. Cholesterol levels significantly increased in group B (p = 0.024). CONCLUSION: CsA trough levels and dosage can be significantly reduced in combination with Everolimus without higher rejection rates and with stable kidney function in oHTX patients.

The prognostic validity of the ventricular evoked response (VER) signals in cardiac transplantation.

INTRODUCTION: Computerized heart allograft rejection monitoring (CHARM) used for non-invasive rejection monitoring in heart transplant recipients is based on the analysis of ventricular evoked response (VER) signals. The aim of this study was to evaluate the prognostic validity of the Tslew(C), a parameter calculated from the VER. METHODS: During orthotopic heart transplantation, 2 unipolar fractally coated screw-in leads were implanted epimyocardially, one to the left and one to the right ventricle, and connected to a telemetric pacemaker. Recordings of intramyocardial electrograms were performed routinely at the hospital. Data processing was done, artifacts were eliminated, and trend curves of the patients were displayed. Tslew(C) was calculated from the tangent of VER and evaluated from 105 patients. The patients were divided into survivor and non-survivor groups. For statistical analysis, the 2-tailed t-test was performed. RESULTS: Patients in the non-survivors group compared with the control group showed a significantly lower Tslew(C) in the final follow-up (p < 0.001). The differences were even more impressive in patients with recorded intramyocardial electrograms 30 days before death or with a cardiac reason for death. Tests were performed to find an optimal prognostic threshold of the Tslew(C), and the value of 26 mV was finally found. CONCLUSION: Tslew(C) can function as prognostic factor after orthotopic heart transplantation. Further studies should be initiated to provide the prognostic threshold so that patients would not be forced to show up routinely every 4 weeks for follow-up visits. Patients would only have to be admitted to the hospital if the Tslew(C) were less than this prognostic threshold.

Computerized heart allograft-recipient monitoring: a multicenter study.

Computerized heart allograft recipient monitoring (CHARM) is a unique concept of patient surveillance after heart transplantation (HTx), based on the evaluation of intramyocardial electrograms (IEGMs) recorded non-invasively with telemetric pacemakers. Previous open, single-center studies had indicated a high correlation between CHARM results and clinical findings. The present study was initiated to assess the suitability of CHARM for monitoring the absence of rejection in a blind, multicenter context. During the HTx procedure, telemetric pacemakers and two epimyocardial leads were implanted in 44 patients at four European HTx centers. IEGMs during pacing were recorded and transferred via the Internet to the CHARM computer center, for automatic data processing and extraction of diagnostically relevant information, i.e., the maximum slew rate of the descending part of the repolarization phase of the ventricular evoked response (VER T-slew). The study period comprised the first 6 months after HTx, during which the transplant centers were blind to the CHARM results. A single threshold diagnosis model was prospectively defined to assess the ability of the VER T-slew to indicate clinically significant rejection, which was defined as an endomyocardial biopsy (EMB) grade greater than or equal to 2, according to the grading system of the International Society for Heart and Lung Transplantation. All EMB slides from three centers were reviewed blind by the pathologist of the fourth center in order that agreement among the histological diagnoses at the various centers could be assessed. Totals of 839 follow-ups and 366 EMBs were obtained in 44 patients. Thirty-seven patients were alive at the end of the study period. Age at HTx, EMB grade distribution, and rejection prevalence varied significantly between the centers. Review of the EMB results showed considerable differences with respect to classification of significant rejection. Comparison of average VER T-slew values with and without rejection in the 15 patients who exhibited both states revealed significantly lower values under the influence of rejection (97+/-13% vs 79+/-15%, P<0.0001). Twenty out of the 25 cases with significant rejection were correctly identified by VER T-slew values below a threshold of 98% (sensitivity =80%, specificity =50%, negative predictive value =97%, positive predictive value =11%; P<0.0005). Of the EMBs, 48% could have been saved if the diagnosis model had been used to indicate the need for EMB. A high negative predictive value for the detection of cases with significant rejection has been obtained in a prospective, blind, multicenter study. The presented method can, therefore, be used to supplement patient monitoring after HTx non-invasively, in particular to indicate the need for EMBs. In centers with patient management similar to the ones who participated in the study, this may allow a reduction in the number of surveillance EMBs.

First use of the Cancion cardiac recovery system in a human.

Animal studies have shown clearly that a peripheral circulatory support system can effectively unload the left ventricle. We report here the first implantation of one such system (Cancion, Orqis Medical, Lake Forest, CA) in a human. The Cancion system consists of a centrifugal pump connected to the circulation via a graft cannula anastomosed to the left axillary artery and a percutaneous cannula placed into the left common femoral artery. Flow is initiated from the femoral to the axillary artery. The system was implanted in a 62-year-old man with ischemic cardiomyopathy suffering from decompensation whose condition had not improved with catecholamine therapy. The Cancion system supported the patient for 3 days, after which it was electively explanted. During the support period, pulmonary capillary wedge pressure dramatically decreased from 28 to 9 mm Hg, left ventricular diastolic dimension decreased from 6.78 to 6.16 cm, creatinine levels decreased from 1.9 to 0.9 mg/dl, cardiac index improved from 1.5 to 2.7 L/min, and ejection fraction improved from 25 to 35%. Together, our data indicate that the Cancion system quickly and effectively improved the patient's hemodynamics. This suggests that the device may one day become a short-term alternative to high dose inotrope therapy and that its application may delay the need for more invasive forms of mechanical circulatory support.