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Abstract A cyclosporine (CsA)-based immunosuppression is associated with an increased incidence of cholelithiasis after heart transplantation. It is not known if tacrolimus (Tac) has comparable biliary side effects in humans. We evaluated the incidence of gallbladder sludge and cholelithiasis under Tac-based immunosuppression by ultrasound examinations in 31 cardiac transplants (25 male, 6 female, mean age: 59 ± 11 years). Data were compared to 57 patients (47 male, 10 female, mean age: 58 ± 11 years) who received CsA-based immunosuppression. 6 patients receiving Tac and 6 patients receiving CsA had already gallstones prior to transplantation so that finally 25 patients of the Tac group and 51 patients of the CsA group could be evaluated. In the Tac group the incidence of biliary sludge was 4% (1 of 25), of gallstones 28% (7 of 25). In comparison, patients receiving CsA developed biliary sludge in also 4% (2 of 51) and gallstones in 25% (13 of 51). Nine of 42 males in the CsA group (21%) and eight of 20 males in the Tac group (40%) developed either gallstones or sludge (n.s). Six of nine females in the CsA group (67%), but none of five females in the Tac group (0%) developed either gallstones or sludge (p = 0.01). In summary, the incidence of biliary disease in patients with Tac is comparable with CsA-based immunosuppression. We recommend regular sonographical examinations to detect biliary diseases as early as possible. In cases of clinically, laboratory and sonographical signs of cholecystitis cholecystectomy is indicated. It seems that towards lithogenicity female patients benefit more from a Tac-based treatment because the occurrence of gallstones is rare.

Byline: E. Kilger (1), F.C. Weis (1), A.E. Goetz (1), L. Frey (1), K. Kesel (1), A. Schutz (2), P. Lamm (2), P. Uberfuhr (2), A. Knoll (3), T.W. Felbinger (1), K. Peter (1) Keywords: Minimally invasive coronary surgery (MICS) Octopus Coronary artery bypass grafting (CABG) Postoperative period Outcomes Abstract: Objective: The purpose of this study was to compare the intensive care course of patients after minimally invasive coronary surgery to conventional coronary artery bypass grafting. Design: Prospective observational study. Setting: Intensive care unit of a university hospital. Patients and participants: One hundred and five patients with two-vessel disease consecutively scheduled for elective coronary bypass surgery were enrolled. Interventions: Two techniques of revascularization were performed: the Octopus procedure via median sternotomy without cardiopulmonary bypass (n=52) and conventional coronary artery bypass grafting CABG (n=53). Measurements and results: Three major categories describing the patients' postoperative course were defined: (1) clinical and laboratory findings, i.e., transfusion rate, catecholamine support, duration of ventilation, Simplified Acute Physiology Score II (SAPS II), serum levels of cardiac enzymes and lactic acid (2) postoperative complications, i.e., incidence of myocardial infarction (MI), atrial fibrillation (AF), and neurological deficits (3) this category was defined as 'the extent of care' as represented by the Therapeutic Intervention Scoring System (TISS), and the length of stay in the ICU and in the hospital. In the Octopus group significantly lower figures were noted for duration of ventilation [6.1(5.5/9.5) vs 10.2(8.2/11.8) h], cardiac enzymes {CK-MB-Mass [5.1(2.0/8.3) vs 31.3(21.4/39.3) ng/ml], and lactic acid [2.0(1.5/3.3) vs 3.2(2.2/6.5) mmol/l]}, incidence of AF (2/52 vs 9/53), and neurological deficits (0/52 vs 4/53), TISS score [72(44/83) vs 84(73/93)], LOS in the ICU [2(1/2) vs 2(2/2) days], and in the hospital [6(5/9) vs 9(8/12) days]. Catecholamine support, SAPS II scores, and incidence of MI of each group did not differ significantly. Conclusions: Off-pump coronary surgery via the Octopus technique was superior to conventional CABG regarding the course of patients in the early postoperative period. This implies benefits for the patients and the entire healthcare system. Author Affiliation: (1) Department of Anesthesiology, University of Munich, Klinikum Grosshadern, Marchioninistrasse 15, 81377 Munich, Germany (2) Department of Cardiac Surgery, University of Munich, Klinikum Grosshadern, Munich, Germany (3) Department of BZT, University of Munich, Klinikum Grosshadern, Munich, Germany Article History: Received Date: 29/05/2000 Accepted Date: 13/10/2000 Article note: Final revision received: 5 October 2000 Electronic Publication

Objective: Heart–lung transplantation for patients with pulmonary atresia and ventricular septal defect is challenging. The aim of the study was to present a single-center experience with heart–lung transplantation in this difficult group of patients. Methods: A retrospective review identified 9 patients aged 4.1 to 45.6 years (median, 25.4 years) with pulmonary atresia and ventricular septal defect who underwent heart–lung transplantation. Four (44.4%) patients had previous heart operations: 3 of them had palliative procedures (systemic-to-pulmonary shunts), and 1 had multistage correction. A standard transplantation method was used, with the exception of 1 patient with heterotaxy syndrome who underwent a modified operation. Major aortopulmonary collateral arteries were controlled by using various techniques. Results: Follow-up ranged between 2 days and 12.6 years (median, 1.2 years). The hospital mortality rate was 22.2% (n = 2). In the late postoperative period, 3 patients died. The survival curve was similar to that of patients with other diagnoses undergoing heart–lung transplantation. The median length of intensive care unit stay was 58 days (range, 22–82 days), and the median length of hospital stay was 83 days (range, 35–136 days). The most common early complication was bleeding requiring re-exploration. In all cases the bleeding was proved to be from collateral vessels. Conclusions: Heart–lung transplantation in patients with pulmonary atresia and ventricular septal defect requires carefully planned and meticulously performed surgical intervention. This management should be taken into consideration as a future option if the specific anatomy is uncorrectable in early childhood, and the palliative procedures should be avoided. [Copyright &y& Elsevier]

Purpose: The present study evaluates clinical feasibility of cardiac multidetector computed tomography angiography (MDCTA) to detect significant stenosis of coronary vessels due to transplant vasculopathy (TVP) after heart transplantation (HTx).Methods: Twenty-eight consecutive male HTx-recipients scheduled for their annual routine conventional coronary angiography (CCA) additionally underwent 64-slice MDCTA.Results: Two patients were excluded from further MDCTA analysis. Out of 371 remaining coronary vessel segments evaluable by CCA, MDCTA was able to depict 302 (81.4%) in diagnostic image quality. On a segment based analysis, sensitivity, specificity, diagnostic accuracy (DA), negative predictive value (NPV), and positive predictive value (PPV) for detection of significant stenosis were calculated with 87.5%, 97.3%, 97.0%, 99.7%, and 46.7%, respectively. On a patient-based evaluation, sensitivity, specificity, DA, NPV, PPV were 100%, 81%, 84.6%, 100% and 55.6%, respectively. Evaluation of stenosis degree by MDCTA showed systematic overestimation of 4.4%. A moderate to good agreement comparing both modalities was found (Pearson's correlation coefficient: 0.64).Conclusion: High NPV suggesting 64-slice MDCTA being a reliable diagnostic tool for ruling out significant stenosis due to TVP in HTx patients. But its clinical value in these particular patients needs further investigation. [ABSTRACT FROM AUTHOR]

Objective and Methods: The Eurotransplant Foundation introduced the lung allocation score (LAS) in Germany on December 10, 2011. We analyzed characteristics of the Munich Lung Transplant Group (MLTG) waiting list during the first 9 months after the introduction of the LAS., Results: A mean number of 39 ± 1 patients were constantly listed for lung transplantation and 60 transplants were performed by the MLTG during the observation period. While the majority (42 ± 0%) of patients waiting for transplant comprised chronic obstructive pulmonary disease (COPD)/emphysema patients, only 26% of transplanted patients suffered from COPD/emphysema. Instead, the majority (42%) of transplanted patients suffered from interstitial lung disease. Waiting times did not markedly change in the LAS era. Notably, patients with interstitial lung disease had shorter waiting times when compared with patients suffering from COPD/emphysema and cystic fibrosis, both on the waiting list and at the time of transplant., Conclusion: The MLTG lung transplant waiting list has not markedly changed during the first 9 months after the introduction of the LAS. Our data indicate that the LAS accommodates disease-specific patient statuses well. Although patients with interstitial lung disease are preferably transplanted, the LAS system provides a very reasonable basis to also list and transplant COPD/emphysema patients., (Georg Thieme Verlag KG Stuttgart · New York.)

Background: The angiographic incidence of coronary dilatation (CD) in the nontransplant population is approximately 0.2% to 5%. The endothelial-dependent and -independent causes for CD are postulated. So far, the incidence and prognosis of CD after heart transplantation is unknown., Methods: We retrospectively analyzed the annual coronary angiographies of 688 heart transplant recipients regarding the incidence of CD (defined as ≥1.5-fold localized increased vessel diameter or diffuse dilatation involving more than 50% of the coronary artery). A subgroup analysis of coronary epicardial (quantitative angiography) and microvascular (doppler flow measurement) vasomotor function in response to acetylcholine (endothelial dependent) and adenosine (endothelial independent) as well as intravascular ultrasound was performed in 177 patients., Results: CD was detectable in 26 patients (3.8%) and was associated with stenosing coronary artery disease in 27% of the patients. Segments with CD tended to have less intimal hyperplasia compared with nondilated segments. A diffuse dilatation (type I-II) was present in 63% of the recipients. The right coronary artery was always involved. The patients with CD (5 of 177) showed a 31% reduced flow velocity in the dilated coronaries compared with the nondilated coronary arteries (P=0.03). Microvascular endothelial-independent function was impaired in CD by -29% (coronary flow reserve mean 1.9 vs. 2.7; P=0.04), whereas endothelial-dependent response was unchanged. Epicardial endothelial-dependent and -independent responses were not different between the groups. Incidence of CD was not associated with limited survival., Conclusion: The incidence of CD in the nontransplant population is similar to that in the transplanted population. However, the latter shows a more diffuse extent. Heart transplantation patients with CD had microvascular endothelial-independent functional limitations and flow deceleration, whereas survival was not affected.

After myocardial infarction, the implantation of stem cell seeded scaffolds on the ischemic zone represents a promising strategy for restoration of heart function. However, mechanical integrity and functionality of tissue engineered constructs need to be determined prior to implantation. Therefore, in this study a novel pulsatile bioreactor mimicking the myocardial contraction was developed to analyze the behavior of mesenchymal stem cells derived from umbilical cord tissue (UCMSC) colonized on titanium-coated polytetrafluorethylene scaffolds to friction stress. The design of the bioreactor enables a simple handling and defined mechanical forces on three seeded scaffolds at physiological conditions. The compact system made of acrylic glass, Teflon®, silicone, and stainless steel allows the comparison of different media, cells and scaffolds. The bioreactor can be gas sterilized and actuated in a standard incubator. Macroscopic observations and pressure-measurements showed a uniformly sinusoidal pulsation, indicating that the bioreactor performed well. Preliminary experiments to determine the adherence rate and morphology of UCMSC after mechanical loadings showed an almost confluent cellular coating without damage on the cell surface. In summary, the bioreactor is an adequate tool for the mechanical stress of seeded scaffolds and offers dynamic stimuli for pre-conditioning of cardiac tissue engineered constructs in vitro.

The objective of this study was to evaluate long-term outcomes of cardiac transplantation (HTx) in different eras of innovation at a single center during a period of 27 years. We performed a retrospective analysis of 960 cardiac allograft recipients (40 re-HTx) between 1981 and 2008. The results of six different eras based on milestones in HTx were analysed: Era 1: the early years (n = 222,1981-1992); era 2: introduction of inhalative nitric oxide, prostanoids, University of Wisconsin solution (UW) replacing Bretschneider's solution (HTK,n = 118, 1992-1994); era 3: statins (n = 102, 1994-1995); era 4: tacrolimus(n = 115, 1995-1996); era 5: mycophenolate mofetil (MMF, n = 143, 1997-2000) and era 6: sirolimus (n = 300, 2000-2008). Outcome variables weresurvival, freedom from cardiac allograft vasculopathy (CAV) and from acute rejection episodes (AREs). Differences in survival was found comparing era 1 and era 2 with era 4 and era 6 (P < 0.001). Organ preservation through UW demonstrated a significantly better survival as compared with HTK(P < 0.001). Less AREs occurred in patients receiving tacrolimus-sirolimus ortacrolimus-MMF (P < 0.001). Patients receiving tacrolimus-MMF showed less CAV than when treated with cyclosporine-MMF (P < 0.005). There were more ventricular assist device implantations and more re-HTx in era 6 (P < 0.0001)than when compared with other eras. Although the causes for improvement in survival over time are multifactorial, we believe that changes in immunosuppressive therapy have had a major impact on survival.

Background: Use of University of Wisconsin solution has been suggested for extended organ preservation >4 hours in experimental cardiac transplantation, but few data have been reported from clinical use. This study investigated the impact of preservation with UW solution after prolonged ischemic times on myocardial damage and outcomes after heart transplantation., Materials and Methods: Between 1994 and 2006, 34 orthotopic heart transplantations were performed at our institution with cold ischemic times of >or=300 minutes (mean, 325.1 +/- 21.3). Donor organs were perfused with and stored in 1000 mL of University of Wisconsin solution. No significant differences were observed with regard to age, gender, diagnosis, donor inotropic support, and donor-recipient weight ratio when compared with recipients undergoing an ischemic time <300 minutes., Results: After a mean follow-up of 47.6 months (range, 1 day to 147.1 months), Kaplan-Meier survival analysis revealed survivals of 91.0% at 3 months, and 82.9% for the entire observation period. The time required to wean from bypass (mean, 78.1 minutes) was equal when compared with that of recipients experiencing grafts undergoing an ischemic time of <300 minutes, but there was a significantly greater average need for inotropic support over the first 48 posttransplant hours. Neither hospital stay in the ICU (mean, 13.0 days; range, 1-55 days) nor the incidence of acute graft failure or survival was different., Conclusion: We conclude that heart preservation with UW limited ischemic damage from prolonged storage and improved myocardial function in the early posttransplant period, thus allowing transplantation of organs with ischemic times >300 minutes.

The optimal maintenance therapy after lung transplantation remains to be established. The aim of this study was to analyse the impact of tacrolimus and mycophenolate mofetil (MMF) as first line immunosuppression on long-term survival and Bronchiolitis Obliterans Syndrome (BOS). From January 1996 through December 2006, all 155 recipients receiving tacrolimus and MMF as maintenance immunosuppression were included in this study. Tacrolimus and MMF was discontinued in 36 patients (23.2%). The overall survival rates were 91.6% at 6 months, 86.4% at 1 year, 74.9% at 3 years, 60.3% at 5 years and 32.4% at 10 years. The overall freedom from acute rejection was 74.6%, 63.2% and 59.4% at 1, 3, and 5 years respectively. The overall BOS-free survival was 95.6% at 1 year, 88.4% at 3 years, 69.5% at 5 years and 30.5% at 10 years. The development of BOS > or = 1 was associated with a significantly increased risk of death and reduced long-term survival. The combination of tacrolimus and MMF offers safe and reliable maintenance immunosuppression after lung transplantation. However, substantial improvements of long-term survival and freedom from BOS might only be achieved by a change in organ allocation policies and patient management beyond differential immunosuppressive protocols.

Background: Chronic renal failure (CRF) is a common complication of calcineurin inhibitor (CNI)-based immunosuppression following cardiac transplantation (HTx). The aim of this prospective study was to evaluate the impact of an immunosuppressive conversion from CNIs to mycophenolate mofetil (MMF) and steroids in cardiac transplant recipients with CRF on renal and cardiac graft function., Methods: Since 1999, 12 HTx recipients (10 men; 58 +/- 3.6 yr of age; 8.7 +/- 4.2 yr after HTx) with CNI-based immunosuppression and a calculated creatinine clearance (CreaCl) <50 mL/min were included. Most patients (10/12) were on cyclosporine and two patients were on tacrolimus prior inclusion. MMF was started with 0.5 g/d and adjusted according to the target trough levels (2-4 ng/mL). Prednisone dosage was 0.4 mg/kg. Subsequently, CNIs were completely withdrawn. Acute rejection episodes were excluded one and three months after conversion by endomyocardial biopsy and by echocardiography every three months thereafter., Results: After a mean follow-up of 20 +/- 16 months, CreaCl improved significantly: pre-conversion vs. post-conversion: 32.8 +/- 12.2 mg/dL vs. 42.8 +/- 21.14 mg/dL, p = 0.03. However, four acute rejection episodes occurred and patients were reconverted to CNIs. Additionally, six patients had a new onset of graft vessel disease (GVD) one yr after conversion. As a result of these adverse events, the study was stopped after inclusion of only 12 of the scheduled 30 patients., Conclusions: Conversion to MMF and steroids after HTx improves renal function, but increases the risk for recurrent rejection and GVD. Therefore, MMF and steroids should only be considered in patients with a markedly low risk for rejection.

Primary pheochromocytomas located outside the adrenal glands account for only 10% of all pheochromocytomas. Mediastinal pheochromocytomas are even rarer and usually represent a therapeutic challenge as they often infiltrate adjacent structures. We report the case of a large primary mediastinal pheochromocytoma in a 65-year-old patient presenting with a sudden angina-like chest pain and dyspnea. Thoracic multislice computed tomography showed an 8 x 5 x 6-cm retrocardiac mass causing compression of both atria and infiltrating the left superior pulmonary vein. The tumor was highly vascularized and presented a blood supply derived from the circumflex artery. The mass was successfully removed by open heart surgery, and the patient was discharged 10 days postoperatively.

Objectives: This study aimed to compare changes in coronary endothelial function, systemic endothelin-1 (ET-1) levels, and vascular remodeling in heart transplant recipients randomized to cyclosporin A (CyA) or tacrolimus (Tac) immunosuppression., Background: Functional endothelial abnormalities and intimal thickening are sensitive measures of early cardiac allograft vasculopathy (CAV)., Methods: The randomized, prospective study was performed in two groups of 22 patients, maintained on Tac or CyA and mycophenolate mofetil immunosuppression, 1 and 12 months after heart transplantation. We investigated epicardial luminal diameter, coronary blood flow velocity, and ET-1 plasma levels at 1 and 12 months after transplantation. Structural coronary alterations were determined using intravascular ultrasound., Results: Epicardial vasomotor function at baseline and during follow-up was comparable between the groups. Deterioration of microvascular endothelial function during follow-up was significantly enhanced in the CyA versus Tac group (p < 0.05). Circulating ET-1 concentration increased in the CyA group but significantly decreased over time in the Tac group (CyA +17% vs. Tac -25%; p < 0.05). The time-dependent increase in mean intimal area was significantly enhanced in the CyA versus Tac group, whereas the vessel area significantly increased during follow-up in the Tac compared with the CyA group., Conclusions: Epicardial endothelial function is comparable between CyA- and Tac-treated patients. Microvascular endothelial function deteriorates more in CyA-treated patients, a finding that correlates with enhanced ET-1 concentration and an increased intimal area during follow-up. The mean vessel area in the Tac group increased over time, indicating positive vascular remodeling. Tac is superior to CyA with respect to microvascular endothelial function, intimal thickening, and vascular remodeling.

Background: Given the central importance of the microvasculature in heart transplant recipients, we investigated the possibility of increasing cardiac perfusion after reduction of low-density lipoprotein (LDL)-cholesterol, lipoprotein (a), C-reactive protein (CRP) and fibrinogen plasma levels after apheresis treatment in transplanted patients., Methods: Ten long-term heart transplant recipients were examined with positron emission tomography (PET) to measure myocardial perfusion before and after a single heparin-mediated extracorporeal LDL/fibrinogen precipitation (HELP)-apheresis treatment. PET studies were performed the mornings before and after the apheresis treatment. Myocardial blood flow at rest and during adenosine-induced hyperemia was measured using (13)N-ammonia., Results: HELP-apheresis reduced the plasma levels of LDL-cholesterol, lipoprotein (a) and C-reactive protein by 48% (p < 0.001), fibrinogen by 42% (p = 0.02), plasma viscosity by 14% (p = 0.004) and erythrocyte aggregation by 28% (p < 0.02). Osmolality (<1%) and hematocrit (<2%) remained stable. A single apheresis treatment increased median corrected rest flow by 17.5% (p = 0.007) and median hyperemic flow by 27% (p = 0.02). Median coronary flow reserve increased by 8.1% (p = 0.09). Hyperemic flow after adenosine infusion increased plasma vascular endothelial growth factor levels only before HELP-apheresis (+60%), indicating better ischemic tolerance after apheresis (p = 0.01)., Conclusions: Myocardial perfusion in transplanted hearts increases significantly after single HELP-apheresis treatment. The present study is only a proof of concept, providing complementary evidence to clinical long-term studies showing that cholesterol reduction either with statins and/or apheresis improves heart transplant outcome.

Bronchiolitis obliterans syndrome (BOS) is the limiting factor to long-term survival after lung transplantation. Previous studies suggested respiratory viral tract infections are associated with the development of BOS. To identify the impact of virus detection in bronchoalveolar lavage (BAL) fluid, we analyzed BAL samples from 87 consecutive lung transplant recipients for human herpesvirus (HHV)-6, Epstein-Barr virus, Herpes simplex virus 1/2, Cytomegalovirus, respiratory syncytical virus and adenovirus by PCR. Acute rejection, BOS and death were recorded for a mean follow-up time of 3.27 +/- 0.47 years. Results of PCR analysis and other potential risk factors were entered into a Cox regression analysis of BOS predictors and death. Only acute rejection was a distinct risk factor for BOS of all stages, death and death from BOS. HHV-6 was detected in 20 patients. Univariate and multivariate analysis revealed that HHV-6 was associated with an increased risk to develop BOS > orb = stage 1 and death, separate from the risk attributable to acute rejection. Identification of HHV-6 DNA in BAL fluid is a potential risk factor for BOS. Our results warrant further studies to elucidate a possible causal link between HHV-6 and BOS.

We investigated the impact of elevated donor serum sodium levels on outcome after heart transplantation in 336 consecutive heart transplantations. Mean donor serum sodium was 148.2+/-10.2 mmol/liter (range 116 to 180 mmol/liter). Recipients were divided into 4 groups with serum sodium levels of 141, 147 and 155 mmol/liter, resulting in sodium levels of: 133+/-6.1 mmol/liter for Quartile A; 144+/-4.2 mmol/liter for Quartile B; 151+/-4.3 mmol/liter for Quartile C; and 162+/-6.6 mmol/liter for Quartile D, respectively (mean+/- standard deviation). Mean occurrence of primary graft failure (PGF) was 3.6% with the following quartile breakdown: A, 3.6%; B, 4.8%; C, 3.6%; and D, 2.4% (p=non-significant [NS]). Mean 5-year survival was 81.32% with: A, 83.51%; B, 76.03%; C, 80.47%; and D, 85.25% (p=NS). Coronary allograft vasculopathy (CAV) occurred in 19% of patients with a quartile breakdown of: A, 16.5%; B, 21%; C, 20%; and D, 14.5% (p=NS). No impact of donor serum sodium levels was seen on early post-operative results or on long-term outcome, indicating that cardiac allografts from donors with elevated sodium levels may be transplanted successfully with favorable results.

The purpose of our investigation was to identify the transcriptional basis for ultrastructural and functional specialization of human atria and ventricles. Using exploratory microarray analysis (Affymetrix U133A+B), we detected 11,740 transcripts expressed in human heart, representing the most comprehensive report of the human myocardial transcriptome to date. Variation in gene expression between atria and ventricles accounted for the largest differences in this data set, as 3.300 and 2.974 transcripts showed higher expression in atria and ventricles, respectively. Functional classification based on Gene Ontology identified chamber-specific patterns of gene expression and provided molecular insights into the regional specialization of cardiomyocytes, correlating important functional pathways to transcriptional activity: Ventricular myocytes preferentially express genes satisfying contractile and energetic requirements, while atrial myocytes exhibit specific transcriptional activities related to neurohumoral function. In addition, several pro-fibrotic and apoptotic pathways were concentrated in atrial myocardium, substantiating the higher susceptibility of atria to programmed cell death and extracellular matrix remodelling observed in human and experimental animal models of heart failure. Differences in transcriptional profiles of atrial and ventricular myocardium thus provide molecular insights into myocardial cell diversity and distinct region-specific adaptations to physiological and pathophysiological conditions. Moreover, as major functional classes of atrial- and ventricular-specific transcripts were common to human and murine myocardium, an evolutionarily conserved chamber-specific expression pattern in mammalian myocardium is suggested.

The aim of this pilot study was to investigate whether de novo calcineurin-inhibitor-free immunosuppression after cardiac transplantation is efficacious and can prevent post-operative renal impairment. Eight patients were treated by combining trough level adjusted sirolimus and mycophenolate mofetil; corticosteroids were given for the first 6 post-operative months only. Survival data, acute rejection episodes and adverse events with a special emphasis on renal impairment, myelosuppression, hypercholesterolemia, hypertriglyceridemia and infections, were recorded. With a follow-up of 3-12 months, patient survival was 100% and freedom from rejection 75%. The mean creatinine levels initially decreased and remained stable thereafter. A moderate myelosuppressive effect did not necessitate dose reduction of immunosuppressants, intermittently elevated cholesterol- and triglyceride levels decreased over time. Most frequent adverse events were pericardial effusions and peripheral edema. Complete abandonment of calcineurin inhibitor therapy by de novo use of the combination sirolimus/mycophenolate mofetil resulted in low rejection rate and avoidance of renal impairment, but should not be used without further evaluation of potential complications in a lager setting.

Background: Neurologic complication is an adverse event associated with mechanical circulatory support. To decrease the incidence of embolic cerebrovascular accidents (CVA) during support with the Novacor left ventricular assist system (LVAS), an expanded polytetrafluoroethylene (ePTFE) inflow conduit has been developed and introduced clinically., Methods: Using clinical data from Europe and Canada, we conducted a retrospective analysis of the incidence of embolic CVA with the ePTFE inflow conduit (n=88) in comparison with the previously used polyester inflow conduits (n=310, including Vascutek n=155 and Cooley n=155). We calculated freedom from embolic CVA, risk reduction for embolic CVA, and linearized rates of embolic CVA., Results: A significant decrease in the incidence of embolic CVA was demonstrated with the ePTFE conduit (ePTFE 10% vs polyester 23%, p=0.002). Kaplan-Meier analysis of freedom from embolic CVA at 180 days after implantation was 86% for the ePTFE group vs 72% for the polyester group (log-rank test, 0.0185). We also found an associated risk reduction of 55% in CVA occurrence in the ePTFE group when compared with the Polyester group (hazard ratio, 0.445; 95% confidence limit, 0.222-0.890; p=0.0221). Linearized CVA rates also were decreased at all time intervals after implantation in the ePTFE group., Conclusions: Preliminary clinical results with the newly introduced ePTFE inflow conduit provide compelling evidence that the ePTFE conduit material significantly decreases thromboembolic complications during mechanical circulatory support with the Novacor LVAS.