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Deep vein thrombosis (DVT) is a common disease associated with high rates of mortality and significant morbidity. The diagnostic approach of DVT has evolved over the years. Algorithmical use of pretest probability, D-Dimer testing and ultrasonography allow safe and accurate investigation of DVT. The anticoagulation therapy, used to treat DVT, includes vitamin K antagonists (VKAs) and low-molecular-weight heparin (LMWH) or unfractionated heparin (UF). The duration of anticoagulation therapy depends on the cause of DVT and patient's clinical profile. Although these conventional therapies are effective, narrow therapeutic index, need for frequent monitoring and various food-drug interactions cause difficulties for patients. In recent decades, new oral anticoagulants have been developed. These drugs focus directly on inhibiting either Factor Xa (rivaroxaban, apixaban, edoxaban) or thrombin (dabigatran). In contrast to warfarin, these new agents have shorter half-life, fewer drug or food interactions, no necessity for a close monitoring and ease of administration. This review summarizes current knowledge about deep vein thrombosis and new treatment aspects with novel oral anticoagulants. [ABSTRACT FROM AUTHOR]

Coronary artery aneurysms are rare entities with a prevalence of 0.15%-4.9%. Giant coronary artery aneurysms are known as more than 2 to 5 cm in size. We present a case of 74 year-old female who was admitted to our clinic with chest pain and dyspnea. Coronary angiography demonstrated a giant right coronary artery (RCA) aneurysm with a significant left-to-right shunt. The patient underwent an open heart surgery. During the exploration, an aneurysm of 40 mm in diameter of the RCA was seen. The aneurysmatic RCA was excluded and continuously closed with the support of intra-aortic balloon pump (IABP). The patient was discharged on the 13th postoperative day without any complication. [ABSTRACT FROM AUTHOR]

Although bullets penetrating into the heart are usually known as fatal, retained cardiac bullets can have a silent course without causing any cardiovascular complications. An 89 year-old patient with myocardial infarction was admitted to our department hemodynamically stable and widely awake. His electrocardiogram didn't show any evidence of ischemia. Cardiac catheterization revealed a three-vessel coronary artery disease. In addition, a circular structure projected on the area of the marginal branch and the V. magna cordis. Removal of the bullet showed that three quarters of myocardium were involved without any perforation. The history of the patient revealed an injury under the heavy fire during World War II. Thus, this case demonstrates that bullets can remain asymptomatic within in the heart for decades. The patient was dis-charged home at the 10th postoperative day after having an uneventful clinical course. [ABSTRACT FROM AUTHOR]

Objectives: Quality control is difficult to achieve in Congenital Heart Surgery (CHS) because of the diversity of the procedures. It is particularly needed, considering the potential adverse outcomes associated with complex cases. The aim of this project was to develop a new method based on the complexity of the procedures. Methods: The Aristotle project, involving a panel of expert surgeons, started in 1999 and included 50 pediatric surgeons from 23 countries, representing the EACTS, STS, ECHSA and CHSS. The complexity was based on the procedures as defined by the STS/EACTS International Nomenclature and was undertaken in two steps: the first step was establishing the Basic Score, which adjusts only the complexity of the procedures. It is based on three factors: the potential for mortality, the potential for morbidity and the anticipated technical difficulty. A questionnaire was completed by the 50 centers. The second step was the development of the Comprehensive Aristotle Score, which further adjusts the complexity according to the specific patient characteristics. It includes two categories of complexity factors, the procedure dependent and independent factors. After considering the relationship between complexity and performance, the Aristotle Committee is proposing that: Performance=Complexity×Outcome. Results: The Aristotle score, allows precise scoring of the complexity for 145 CHS procedures. One interesting notion coming out of this study is that complexity is a constant value for a given patient regardless of the center where he is operated. The Aristotle complexity score was further applied to 26 centers reporting to the EACTS congenital database. A new display of centers is presented based on the comparison of hospital survival to complexity and to our proposed definition of performance. Conclusion: A complexity-adjusted method named the Aristotle Score, based on the complexity of the surgical procedures has been developed by an international group of experts. The Aristotle score, electronically available, was introduced in the EACTS and STS databases. A validation process evaluating its predictive value is being developed. [Copyright &y& Elsevier]

In this investigation, we hypothesize that quality of oral anticoagulation (OA) and long-term outcome after mechanical heart valve (MHV) replacement with self-management (Self-M) of OA is superior to conventional anticoagulation treatment (Conv-T), even in outside trial conditions. One hundred sixty patients (78.8% aortic valve replacements) were trained in international normalized ratio Self-M and 260 patients (86.2% aortic valve replacements) preferred Conv-T. Mean follow-up was 8.6 ± 2.1 years, representing 3612 patient-years. During follow-up, 37.2% bleedings and 10.6% thromboembolic events were recorded in the Self-M group versus 39.6% bleedings (P = 0.213) and 15.4% thromboembolic events (P = 0.064) in the Conv-T group. Serious adverse events were significantly lower in the Self-M group [grade III bleeding events causing disability or death: 0 versus 4.6% (P = 0.03); grade III thromboembolic events: 0.6 versus 5.0% (P = 0.011)]. Patients with Self-M were significantly more satisfied with their OA management and their quality of life (P < 0.001). Actuarial survival after 1, 5 and 10 years was 100, 99 and 97 with Self-M and 100, 95 and 81% with Conv-T, respectively (P < 0.001). Univariate risk factors for mortality were age (P = 0.008), type of operation (P = 0.021) and conventional OA (P < 0.001). In multivariate analysis, only conventional OA reached significance (P < 0.001). We conclude that in a routine setting under outside trial conditions Self-M of OA improves long-term outcome and treatment quality.

Background: Tissue engineering of autologous heart valves with the potential to grow and to remodel represents a promising concept. Here we describe the use of cryopreserved umbilical cord blood-derived CD133(+) cells as a single cell source for the tissue engineering of heart valves., Methods: After expansion and differentiation of CD133(+) cells, phenotypes were analyzed by immunohistochemistry and cryopreserved. Heart valve scaffolds fabricated from a biodegradable polymer (n = 8) were seeded with blood-derived myofibroblasts and subsequently coated with blood-derived endothelial cells. Afterward, the heart valve constructs were grown in a pulse duplicator system. Analysis of all heart valves, including histology, immunohistochemistry, electron microscopy, fluorescence imaging, and biochemical and biomechanical examination, was performed., Results: The tissue-engineered heart valves showed endothelialized layered tissue formation including connective tissue between the inside and the outside of the scaffold. The notion of an intact endothelial phenotype was substantiated by fluorescence imaging studies of cellular nitric oxide production and Ca(2+) signaling. Electron microscopy showed that the cells had grown into the pores and formed a confluent tissue layer. Biochemical examination showed extracellular matrix formation (77% +/- 9% collagen of human pulmonary leaflet tissue [HPLT], 85% +/- 61% glycosaminoglycans of HPLT and 67% +/- 17% elastin of HPLT)., Conclusions: Importantly, this study demonstrates in vitro generation of viable human heart valves based on CD133(+) cells derived from umbilical cord blood. These findings constitute a significant step forward in the development of new clinical strategies for the treatment of congenital defects., (2010 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Calcineurin-inhibitor-(CNI)-induced renal failure is one major cause of morbidity in cardiac transplantation (HTx). In this prospective, randomized, multicenter trial, the impact of immunosuppressive conversion toward CNI-free (mycophenolate mofetil [MMF] and sirolimus) or a CNI-reduced immunosuppressive regimen on renal function, efficacy, and safety was evaluated., Methods: Since 2004, 63 HTx-patients (0.5-18.4 years after HTx) with CNI-based immunosuppression and reduced creatinine clearance less than 60 mL/min (39+/-15 mL/min) were included in this trial. Patients in the CNI-free-Group (group 1) were converted to sirolimus that was started with 2 mg/day until target trough levels (8-14 ng/mL) were achieved. Subsequently, CNIs were withdrawn. In CNI-reduction-Group (group 2), CNI target trough levels were reduced by 40%. In both groups MMF was continued and trough level adjusted (1.5-4 microg/mL)., Results: Patients demographics and survival (mean follow-up time: 16.7+/-9 months) was equal (100%). Renal function improved significantly after complete CNI withdrawal while remaining unchanged with CNI-reduction (Creatinine clearance after 12 months: 53+/-24 mg/dL [group 1] vs. 38+/-20 mg/dL [group 2], P=0.01). End-stage renal failure (hemodialysis) was avoided by CNI-withdrawal and occurred only after CNI reduction (n=6; P=0.01). Acute rejection episodes were more common in group 2 (4 vs. 2). Graft function remained stable (echocardiography) within both groups. Adverse events were more common in group 1 (65%) than in group 2 (n=40%) and were responsible for discontinuation in 4 and 0 cases, respectively., Conclusions: Conversion toward a CNI-free immunosuppression (Mycophenolate, sirolimus) is superior to CNI-reduced immunosuppression in improving renal failure in late HTx-recipients. However, this benefit is relativized by the increased incidence and severity of sirolimus/MMF-associated side effects.

Background: Stenoses of venous grafts represent a major limitation in coronary artery bypass surgery. The use of viral vectors to facilitate over-expression of factors within the graft to promote long-term patency is a promising new therapeutic concept. One of the viral vector systems is the adeno-associated virus (AAV); a non-pathogenic single stranded DNA virus, which elicits only low immunological responses., Methods and Results: Recombinant AAV vector coding for beta-galactosidase was produced and transferred ex vivo using intraluminal application to previously harvested rabbit internal jugular vein grafts (n = 8). The 30 min after application, an end-to-end anastomosis of each graft as a bypass to the carotid artery was performed in a previously established rabbit bypass model. X-Gal-staining of the grafts was performed after killing the animals to quantify gene expression. AAV transduction was successful in 100% of the grafts. After 30 days, beta-galactosidase gene expression could be assessed in the medial layer of the graft. Furthermore, no signs of inflammation could be detected., Conclusions: These findings suggest that recombinant AAV vectors are an alternative to the widely used adenoviral based vectors. These data support the further use of AAV vectors to overcome intimal hyperplasia after vein graft coronary artery bypass surgery.

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.

Introduction: Although amphotericin was the gold standard in the treatment of invasive aspergillosis in transplant recipients, nephrotoxicity and lack of efficacy often limits its use. Itraconazole is better tolerated but less efficacious and influences immunosuppressant trough levels significantly. We report our first clinical experience with the use of caspofungin as first-line therapy in heart and lung transplant recipients with invasive aspergillosis., Methods: Caspofungin was administered at 50 to 70 mg/day in heart and lung transplant recipients with renal impairment while invasive aspergillosis was diagnosed and classified. Aspergillus serology, serologic inflammatory markers, and X-rays were taken to monitor infectious activity. Creatinine and immunosuppressant trough levels were monitored closely., Results: Invasive aspergillosis was diagnosed by chest X-ray, serology, and positive sputum in 1 heart-lung, 7 heart, and 4 single-lung transplant recipients, and caspofungin was administered for a mean time of 21 +/- 9 days. Basic immunosuppressants were tacrolimus in 9 patients or cyclosporine in 3. Complete remission was achieved in 10 patients (83%). Adverse effects of caspofungin were fever in 6, diarrhea in 3, and neutropenia in 1. Renal function remained stable (3.2 +/- 1 mg/dl before vs 2.3 +/- 0.9 mg/dl after, p = 0.07). Trough levels of all immunosuppressants did not change significantly during caspofungin treatment (10.9 +/- 4.1 ng/ml before vs 9.9 +/- 4.0 ng/ml after [p = 0.31] for tacrolimus; 214 +/- 98 ng/ml before vs 229 +/- 88 ng/ml after [p = 0.41] for cyclosporin A), while the administered dosage remained stable., Conclusion: In heart and lung transplant recipients with invasive aspergillosis, caspofungin seemed to be an effective anti-fungal agent with a promising safety profile. Further prospective randomized trials are needed to investigate an advantageous role of caspofungin in the treatment of invasive aspergillosis.

Anomalous origin of the left coronary artery from the pulmonary artery (ALCAPA) is a rare congenital defect. This anomaly leads to a coronary hypoperfusion phenomenon and to substantial left ventricular dysfunction caused by abnormal perfusion of the left ventricle. The optimal surgical management of such cases is not clearly established. Here, we report the successful anatomic repair of ALCAPA arising from the non-facing sinus of Valsalva of the pulmonary artery in a 5-kg patient. In order to perform the repair, we created an autologous extrapulmonary tunnel (from a pulmonary artery flap and autologous pericardium), which we implanted into the ascending aorta. Because of post-cardiotomy heart failure, we implanted an extracorporeal membrane oxygenation device during the same procedure. After recovery of the failing heart, the device was easily ex-planted, and the patient was discharged from the hospital on postoperative day 30.

Aim: The procedure of coronary bypass grafting (CABG) with coronary endarterectomy (CE) is controversial. However, in the setting of severely calcified coronary arteries CE may enable complete revascularization. Complete revascularization, especially of the left anterior descending artery (LAD), is important for long-term outcome. In this study we assessed long-term LAD graft patency and anterior wall function after CABG with CE of the LAD., Methods: Between 1984 and 1992, 283 patients underwent CABG with CE of the LAD. In 50 patients (47 men), aged 59+/-7.6 (40-77), clinical reassessment and surveillance angiography were performed. In all patients complete revascularization had been achieved with 3.5+/-1 (1-5) grafts/patient with 1-3 CE/patient. The LAD was grafted either with a saphenous vein segment (N=38) or with left intern thoracic artery (N=12). A graft obstructed less than 50% in diameter was defined as patent., Results: At follow-up 39 patients (78%) were in CCS class I/II and had improved significantly (P<0.000). Control angiography after 7.6+/-2.5 (3.5-11.7) years after CABG revealed a patent LAD graft in 30/50 patients (60%). Actuarial graft patency was 100%, 96%, and 56% after 2, 5, and 10 years and was lower in patients with diabetes (P=0.001). Deterioration of anterior wall motion was observed in 17 patients (34%) and was more frequent if anterior wall motion was preoperatively normal (P=0.002), irrespective of LAD graft patency., Conclusion: Clinical status and long-term graft patency of grafts on endarterectomized LAD is considerable. However, patients with preoperatively normal anterior wall function are at increased risk for myocardial damage in the long-term.

Purpose: Currently we are exploring the impact of using rapid prototyping techniques for surgical planning and intraoperative orientation during the correction of complex congenital malformation., Description: We studied a patient with a left abnormal subclavian artery and right descending aorta as a rare cause of dyspnea and dysphagia. The patient was examined by magnetic resonance imaging angiography. The image data were visualized and reconstructed. Afterward a replica of the malformation was fabricated using a rapid prototyping machine. In addition, a stereolithographic model of an intracardiac lesion (ventricular septal defect) was fabricated with data obtained from a computed tomographic scan., Evaluation: Using data derived from a magnetic resonance imaging angiography or computed tomographic scan linked to proprietary software, we were able to create three-dimensional reconstructions of complex vascular pathology and intracardiac lesions. In addition, we fabricated replicas of congenital malformations using a rapid prototyping machine. The models could be sterilized and taken to the operating room for orientation during the corrective surgical procedure., Conclusions: Stereolithographic replicas are helpful for choosing treatment strategies, surgical planning of corrections, and intraoperative orientation, and as demonstrations on life-like models for the patient.

Heart transplantation represents a valuable therapeutic option for patients with congenital heart disease and end-stage heart failure. We report the case of a 15-year-old patient with situs inversus and additional complex congenital malformations of the heart who underwent several previous palliative operations. Orthotopic cardiac transplantation with several technical modifications was performed successfully. At 18 months post-operatively the patient is free from rejection and doing well in New York Heart Association (NYHA) Class I status.

Introduction: Heart rate variability (HRV) is reduced in adults and children after cardiac transplantation. Testing of HRV has been used to assess re-innervation of the cardiac graft; its reliability in ruling out acute graft rejection is still under investigation. This study used a short-term test on HRV in 23 heart and heart-lung transplanted children and adolescents and compared the results with 24-h ECG recordings., Patients and Methods: Twenty-three subjects (16.3+/-4.2 yr; 10 females) underwent a 10-min HRV test at two occasions and one 24-h ECG. HRV was calculated according to the time domain method (RR interval, standard deviation of RR interval) and the frequency domain method (total power, LF and HF for assessment of sympathovagal modulation of heart rate)., Results: Correlation between the short-term tests and 24-h ECG was high with regard to the frequency domain analysis of HRV. Correlation was less pronounced in the time domain method., Conclusions: In heart and heart-lung-transplanted children and adolescents, due to reduced overall HRV short-term testing may give as reliable data as 24-h ECG. Therefore, especially when power spectral analysis has to be performed as a longitudinal assessment of re-innervation of the cardiac graft, short-term testing may offer an easily applicable and non-invasive diagnostic tool. Further studies are warranted to investigate whether HRV testing may contribute to rule out acute graft rejection.

Objective: Assessing sympathovagal balance by calculating LF/HF-ratio from power spectral analysis (PSA) of heart rate variability (HRV) may be difficult in adolescents as chaotic breathing leads to methodical bias and metronomic breathing is not easy to perform. Diastolic blood pressure variability (dBPV) is less influenced and may therefore offer more stable values for calculations. The present study was performed on 72 paediatric subjects to investigate possible alternative LF/HF-calculations from PSA of HRV and dBPV., Methods and Results: Seventy-two paediatric individuals in three groups: 12 controls, 17 heart- and heart-lung-transplanted children (TX) and 43 adolescents born small for gestational age (SGA). Short-term beat-to-beat HRV and BP-recordings were made supine and during active standing. Ratios calculated: LF/HF from HRV, LF/HF from dBPV, LF-dBPV/HF-HRV and LF-HRV/HF-dBPV. LF/HF from dBPV as well as LF-HRV/HF-dBPV did not correlate with LF/HF-HRV. Correlation of LF/HF from HRV and LF-dBPV/HF-HRV was high especially in TX and in patients with resting heart rate of above 90 beats per minute., Conclusions: In adolescents, the ratio of LF-dBPV/HF-HRV may be an alternative method for calculating sympathicovagal balance being less influenced by breathing patterns. In younger patients with elevated resting heart rate, but also in patients with very low HRV such as TX-patients this method could be a supplemental diagnostic tool whenever autonomic nervous control on the cardiocirculatory system has to be assessed.

Background: Tissue engineering of autologous heart valves with the potential to grow and to remodel represents a promising concept in pediatric cardiovascular surgery. Currently we are exploring the impact of cryopreserved human umbilical cord cells (CHUCCs) for the fabrication of tissue-engineered heart valves for patients diagnosed prenatally with congenital heart lesions, potentially enabling heart valve replacement in the early years of life., Methods: Human umbilical cord cells were isolated from vascular segments of umbilical cords and cryopreserved in a cell bank. After 12 weeks the cryopreserved cells were again expanded in culture and characterized by histology, immunohistochemistry, and proliferation assays. Trileaflet heart valve scaffolds were fabricated from a porous polymer (P4HB, Tepha Inc, Cambridge, MA) and sequentially seeded with CHUCCs (n = 10). Five of the heart valve constructs were grown for 7 days in a pulse duplicator and, as a control, five constructs were grown under static cell culture conditions for 7 days. Analysis of all tissue-engineered heart valves included histology, immunohistochemistry, electron microscopy, functional analysis, and biomechanical and biochemical examination., Results: We found that CHUCCs remained viable after 12 weeks of cryopreservation and showed a myofibroblast-like morphology that stained positive for alpha-actin and fibroblast specific marker. Histology of the tissue-engineered heart valves showed layered tissue formation, including connective tissue between the inside and the outside of the porous scaffold. Immunohistochemistry was positive for collagen (types I, III, and IV), desmin, laminin, and alpha-actin. Electron microscopy showed that the cells had grown into the pores and formed a confluent tissue layer during maturation in the pulsatile flow system. Biochemical examination showed an increase of extracellular matrix formation in constructs after pulsatile flow exposure compared with the static control group. Functional analysis demonstrated a physiological increase of the intracellular Ca2+ concentration of the recultivated cells and the conditioned constructs after stimulation with histamine., Conclusions: This study demonstrates in vitro generation of viable and functional human heart valves based on CHUCCs and biomimetic flow culture systems. The CHUCCs demonstrated excellent growth potential and abilities of in vitro tissue formation. These findings suggest the potential benefit of establishing autologous human cell banks for pediatric patients diagnosed intrauterinely with congenital defects that will potentially require heart valve replacement in the early years of life.

Unlabelled: We report the early and late outcome following left-sided mechanical heart valve replacement in children. Between 10/1981 and 02/2001, 27 children (13 male, mean age 7.2 +/- 5.2 years, range 0.53-15.7 years) underwent mechanical mitral (MVR 16), aortic (AVR 9) or double valve replacement (DVR 2) with St. Jude Medical valves. Eighteen children (66.7%) had undergone previous cardiac surgery. Valve disease was congenital in 23, due to endocarditis in 2 and rheumatic in 2 patients. Concomitant cardiac surgery was performed in 12 patients (44.4%). Operative mortality was 3.7% (1/27). Perioperative complications were complete heart block (5) and myocardial infarction (1). Mean follow-up was 6.5+/-5.9 years (range 0.4-19 years, total 169.9 patient-years). There was one valve-related late death due to mitral valve thrombosis without phenprocoumon. Actuarial survival after 1, 5 and 10 years was 93, 93 and 93%. Late complications included endocarditis (2), minor hemorrhagic event (1) and stroke (1). Overall 10-year freedom from any anticoagulation-related adverse event under phenprocoumon was 91% (1.3%/patient year). Eight patients required reoperations: re-MVR (5; outgrowth of the prostheses (3), pannus overgrowth (2)), closure of paravalvular leak after AVR (2), and re- DVR (1; endocarditis). Actuarial freedom from reoperation after 1, 5 and 10 years was 96, 88 and 76%., Conclusion: Mechanical valve prostheses are a valuable option for left-sided heart valve replacement in pediatric patients with good results. Operative mortality and the incidence of any valve-related events as endocarditis, reoperation, thromboembolism or anticoagulation related bleeding is acceptable.

Purpose: The purpose of our study was to evaluate the stability of an artificially seeded endothelial cell layer on porcine aortic prostheses under in vivo conditions in the arterial system., Description: Ten female sheep were divided into two groups. Animals of the study group (n = 7) had dissection of their right external jugular vein for cell harvesting. Myofibroblasts and endothelial cells were labelled with PKH-26, seeded onto pretreated (10% citric acid) porcine glutaraldehyde-fixed aortic valves (Freestyle, Medtronic Inc, Duesseldorf, Germany), and the valves were implanted into the descending aorta. Controls (n = 3) received pretreated but unseeded valves. A shunt between the aortic arch and the left atrial appendage ensured systolic or diastolic leaflet motions, or both, that were documented by sonography. After 3 months the valves were explanted. Specimens for scanning electron microscopy and immunohistochemical staining were taken prior to implantation and after explantation., Evaluation: A neointimal proliferation was detected in the control group. No endothelial cells were found on the leaflets and the sinuses, but erythrocytes and thrombocytes were seen entrapped within the collagen fibers. Thrombus formation was documented macroscopically and histologically on the leaflets and the sinuses. In the study group a confluent endothelial cell layer was documented on the walls and leaflets. Neither neointimal proliferation nor any clots were seen. Some cells were still labelled positively indicating their origin from the initial cell seeding. No dilatation of any prosthesis was observed, but all valves showed slight thickening of the leaflets., Conclusions: The artificially seeded endothelial cell layers remained stable under in vivo conditions in the arterial system. Biocompatibility of the prostheses seemed to be improved by reduction of thrombogenicity.

Background: In end-stage cardiomyopathy where concomitant chronic renal failure is a contraindication for cardiac transplantation (HTx), simultaneous heart and kidney transplantation (HKTx) may be the only feasible therapeutic option. Due to the increased donor shortage, the clinical outcome of combined HKTx patients on tacrolimus-based immunosuppression was assessed and compared with a group of HTx patients., Methods: Three hundred forty-nine HTxs, including 13 (4%) combined HKTxs, were performed since 1995. Two hundred twenty-one HTx and all HKTx recipients received tacrolimus-based immunosuppression. Acute rejection episodes (AREs), infections, renal function and clinical outcome were evaluated. Pre-operative renal diagnoses for HKTx patients included cystic nephropathy (n = 4), glomerulonephritis (n = 4), cytostatica-induced nephropathy (n = 1), chronic rejection after renal transplant (n = 1), reflux nephropathy (n = 2) and chronic calcineurin-inhibitor -induced nephropathy after HTx (n = 1). Twelve patients (92%) were on hemodialysis pre-operatively, 1 underwent implantation of a left ventricular assist device (LVAD) before HKTx., Results: After 4.7 +/- 2 years, 92% of HKTx compared with 85% of HTx patients had survived (p = 0.42). Acute cardiac rejection episodes were more frequent in HTx than in HKTx patients (0.04 +/- 0.09 vs 0.02 +/- 0.04 ARE/100 patient-days; p = 0.07). Incidence of infection was comparable (0.3 +/- 0.2 vs 0.5 +/- 0.4 infection/100 patient-days). Freedom from transplant vasculopathy was 100% in the HKTx group compared with 71% in the HTx group after 4 years (p = 0.04)., Conclusions: Tacrolimus-based immunosuppression yields promising long-term results in HKTx and HTx. The incidence of transplant vasculopathy seems to be lower after HKTx than after HTx. If these results are secondary to a protective effect of tacrolimus-induced tolerance or of tolerance-associated co-transplantation they will need to be investigated in prospective multicenter trials.

Advanced recipient age is considered a relative contraindication for heart transplantation because it might be associated with increased morbidity and mortality. We analyzed 349 consecutive heart transplantations performed at our institution from 1995 to 2002 (n = 349, mean follow-up 3.5 +/- 2.5 years). The survival rate was lower in older recipients. Less chronic rejection but increased risk for infectious complications, renal failure and neoplasms indicate the need for decreased immunosuppression and effective infection prophylaxis in older recipients.

Mechanical circulatory support is successfully applied to patients with low cardiac output. The MEDOS/HIA-System provides pulsatile ventricular assistance for pediatric and adult patients. Our experience with 13 consecutive patients with the MEDOS is reported. Perioperative survival was 84.6%, complications occurred in 61% (31% thrombembolism, 23% rethoracotomy, 7% infections). Mean duration of support was 17.6 +/- 14.6 days (1-45 days). Bilirubin decreased from 3.9 +/- 2.3 to 2.7 +/- 1.6 mg/dL; creatinine from 1.6 +/- 1 to 1.4 +/- 0.8 mg/dL; lactate from 5.8 +/- 4.2 to 1.7 +/- 1.5 (P = 0.027; Wilcoxon). All patients who underwent subsequent heart transplantation (6 of 13; 46%) were discharged from hospital. For 38.5% of the patients no organ offer was received. Mechanical circulatory support with the MEDOS/HIA-System can be performed successfully for bridging to transplantation. Secondary organ functions improve under this pulsatile circulatory assistance. Hemorrhage and thromboembolic events are the most frequent complications.