Comparison of the Prolonged- and Immediate-Release Tacrolimus Capsule Formulation: The Patient's View and Medication Satisfaction of Patients After Pediatric Heart Transplantation.

BACKGROUND: Medication adherence is essential for long-term success after pediatric organ transplantation. Causes of reduced adherence should be detected early to improve the consequent medication intake. We describe the influence of switching from tacrolimus twice daily (tacrolimus-BID) to tacrolimus once daily (tacrolimus-QD) on medication satisfaction and medication adherence in patients after pediatric heart transplantation. METHODS: A retrospective analysis was conducted regarding patient satisfaction and adherence to the immunosuppressant tacrolimus after pediatric heart transplantation, before and after conversion from tacrolimus-BID to tacrolimus-QD, using questionnaires. RESULTS: Thirty-eight patients were enrolled (tacrolimus-BID: n = 35, mean age 15.7 ± 5.2 years; tacrolimus-QD: n = 38, mean age 16.2 ± 5.6 years). The amount of unadministered medication in the last 3 months did not differ between the 2 pharmaceutical forms. However, 17% (n = 6) reported unstable tacrolimus trough levels when taking tacrolimus-BID, vs 8% (n = 3) under tacrolimus-QD (P = .453). However, there was no statistically significant difference in the stability of the last 6 trough levels of each patient (P = .074). A total of 57% (n = 20) of patients had subjective side effects before conversion, compared to only 29% (n = 11) after conversion (P = .013). Regarding the intensity of the side effects, 6 patients reported strong/very strong side effects when taking tacrolimus-BID vs 1 patient when taking tacrolimus-QD (P = .250). In addition, the overall satisfaction with the immunosuppressant was higher under tacrolimus-QD (92% vs 83%; P = .508). However, this improvement was statistically not significant and may not be clinically relevant. CONCLUSIONS: The amount of forgotten medication was not reduced after conversion from tacrolimus-BID to tacrolimus-QD. However, subjective side effects as well as patient satisfaction improved under tacrolimus-QD.

Tricuspid Annular Plane Systolic Excursion (TAPSE) correlates with mean pulmonary artery pressure especially 10 years after pediatric heart transplantation.

Tricuspid annular plane systolic excursion (TAPSE) is important in the noninvasive echocardiographic assessment of right heart function. This retrospective observational study shows correlations of TAPSE with invasive right heart catheterization parameters after pediatric heart transplantation (HTx). The study included patients after pediatric HTx with cardiac catheterizations in 2018/2019 and measurement of TAPSE (n = 52 patients with 57 examinations; 50.9% adults, 52.6% female, median age: 18.54 years). TAPSE was compared with normal values. Stepwise, linear and multiple regression were used to show influencing variables on TAPSE. Mean TAPSE z-score was -3.48 (SD: 2.25) and 68.4% of HTx-recipients showed abnormally reduced TAPSE (z-score ←2) compared to normal values. Multiple regression (p-value <0.001; corrected R2 = 0.338) showed significant correlations of time since HTx (p-value <0.001) and mPAP (p-value: 0.008) with TAPSE z-scores. Divided into subgroups (time since HTx <10 and ≥10 years), TAPSE and mPAP correlated only ≥10 years after HTx (p-value = 0.002). This study provides data of TAPSE even ≥10 years after pediatric HTx. Most patients showed a decreased TAPSE early after HTx, which improved over time. TAPSE z-scores correlated significantly with time since HTx and mPAP, especially ≥10 years post-HTx. Therefore, TAPSE must be used carefully in the early follow-up.

Cobra-Head Cuffed Vascular Graft as Right Ventricle-to-Pulmonary Artery Shunt in Norwood Procedure.

BACKGROUND: Right ventricle-to-pulmonary artery (RV-PA) shunt as a part of the Norwood procedure underwent many modifications. We present our experience with a commercially available polytetrafluoroethylene vascular graft with cobra-head cuff as an RV-PA shunt. METHODS: A consecutive series of 52 children with hypoplastic left heart syndrome (median age 8 [range, 2-68] days, median weight 3200 [range, 2060-4400] g) underwent the Norwood procedure with a cobra-head cuffed RV-PA shunt (6 mm). The cuffed end was used for the central PA reconstruction. A retrospective analysis of clinical results, PAs development, and shunt-related complications, interventions, and technique of Glenn operation was performed. The study endpoint was Glenn operation with shunt removal or interstage death. RESULTS: The hospital and late interstage mortality was 3.8% (n = 2 of 52) and 4% (n = 2 of 50), respectively, and was not shunt-related. During mean follow of 3.7 ± 2.5 years, 48 (92.3%) children underwent Glenn operation at a median age of 6 (range, 2.6-9.1) months. Angiography before the second stage revealed satisfactory branch PAs development (maximum and minimum McGoon ratio of 1.95 ± 0.36 and 1.38 ± 0.38, respectively). The mean maximal diameter of the left PA was smaller than that of the right PA (7.13 ± 2.1 mm vs 8.42 ± 2.2 mm; P = .017), without differences in mean minimal diameter. Two infants required stent implantation in proximal shunt end and 1 required urgent Glenn operation because distal shunt thrombosis. During Glenn operation, 11 (22.9%) children required patch reconstruction of central PAs. CONCLUSIONS: The cobra-head cuffed graft allowed easy and reproducible reconstruction of the central PA during the Norwood procedure. Using this technique, the development of PAs is satisfactory, the rate of shunt-related complications and interventions is low, and the second stage can be performed without patch material.

Conversion to everolimus in pediatric heart transplant recipients is a safe treatment option with an impact on cardiac allograft vasculopathy and renal function.

BACKGROUND: Cardiac allograft vasculopathy (CAV) and nephrotoxicity affect long-term survival after heart transplantation (HTX). Studies, mostly conducted in adults, showed a positive effect of everolimus (EVL) on these problems. We describe the effects of conversion of the immunosuppressive therapy to an everolimus including regime on CAV, renal function, and safety in heart transplanted children/adolescents. METHODS: This retrospective single-center study included 36 participants (mean time after HTX 6.3 ± 4.7 years). Descriptive pre/post-comparisons were performed with an observation period partially up to 4 years. Impact on CAV was assessed based on intravascular imaging and Stanford grading. Safety analysis included cytomegalovirus (CMV)-infection and acute rejection. RESULTS: In terms of CAV (9 out of 36 patients) four showed no progression, three an improvement, one a worsening; one new diagnosis. The average CrCl showed a significant improvement 6, 12, and 24 months after conversion regarding all patients (n = 29). There was no acute rejection or CMV-infection. CONCLUSION: Conversion to an EVL-based therapy after pediatric HTX is a safe immunosuppressive regime without increasing risk of acute rejection or CMV-infection. There was some evidence of reduction in progression of CAV and a significant improvement of the renal function.

Cardiac allograft vasculopathy: Differences of absolute and relative intimal hyperplasia in children versus adults in optical coherence tomography.

BACKGROUND: Intracoronary imaging enables an early detection of intimal changes. To what extend the development of absolute and relative intimal hyperplasia in intracoronary imaging differs depending on age and post-transplant time is not known. METHODS: Aim of our retrospective study was to compare findings between 24 pediatric (cohort P) and 21 adult HTx patients (cohort A) using optical coherence tomography (OCT) at corresponding post-transplant intervals (≤5 years: P1 (n = 11) and A1 (n = 10); >5 and ≤ 10 years: P2 (n = 13) and A2 (n = 11),. Coronary intima thickness (IT), media thickness (MT) and intima to media ratio (I/M) were assessed per quadrant. Maximal IT >0.3 mm was considered absolute, I/M > 1 relative intimal hyperplasia. RESULTS: Compared to A1, I/M was significantly higher in P1 (maximal I/M: P1: 5.41 [2.81-13.39] vs. A1: 2.30 [1.55-3.62], p = 0.005), whereas absolute IT values were comparable. In contrast, I/M was comparable between P2 and A2, but absolute IT were significantly higher in A2 (maximal IT: P2: 0.16 mm [0.11-0.25] vs. A2: 0.40 mm [0.30-0.71], p < 0.001). A2 presented with higher absolute IT (maximal: A1: 0.16 mm [0.12-0.44] vs. A2: 0.40 mm [0.30-0.71], p = 0.02) and I/M (maximal I/M A1: 2.30 [1.55-3.62] vs. A2: 3.79 [3.01-5.62], p = 0.04). CONCLUSION: Our results suggest an age- and time-dependent difference in the prevalence of absolute and relative intimal hyperplasia in OCT, with an early peak in children and a progressive increase in adults.

Percutaneous pulmonary valve implantation in a dysfunctional Trifecta® bioprothesis after high-pressure balloon fracturing.

A percutaneous pulmonary valve-in-valve (PPVIV) implantation in small surgical tissue valves may be limited due to the valve's initial diameter. Fracturing of the valve's integrity by high-pressure balloons may enhance the diameter and facilitate subsequent PPVIV with a large valve. To the best of our knowledge, the Trifecta® valve seemed not to be accessible for fracturing. We report a case of successful 19-mm Trifecta valve fracturing, followed by PPVIV using a 26-mm Edwards SAPIEN 3 valve in pulmonary position. By repetitively using a high-pressure balloon 5 mm larger than the labeled valve size, we were able to fracture the valve's integrity and implant a 26-mm valve thereafter. Therefore, Trifecta valve appears to be suitable for valve ring fracturing and subsequent PPVIV in certain patients.

Geometry of the pulmonary arteries before the Fontan operation: can we influence it during the Norwood procedure?

OBJECTIVES: The right ventricle-to-pulmonary artery (RV-PA) shunt provides stable haemodynamics after the Norwood procedure but can influence development of the central pulmonary arteries (PAs). The goal of this study was to analyse the geometry of the central PAs in children with hypoplastic left heart syndrome before the Fontan operation with respect to the RV-PA shunt site and the type of the second-stage operation. METHODS: A total of 161 children with hypoplastic left heart syndrome, median age 2.7 (range 1.3-9.8) years and median weight 12.7 (range 7.6-26.1) kg, underwent the Fontan operation after having had the Norwood procedure with an RV-PA shunt. The patients were divided into 2 groups: left-sided RV-PA (L-RV-PA) (n = 129) with the shunt on the left and right-sided RV-PA (n = 32) with the shunt on the right side of the neoaorta. Angiographic data obtained before the Fontan and all cardiac catheterization interventions were analysed retrospectively. RESULTS: Between the second and third stages, as well as directly before the Fontan operation, the L-RV-PA group required more PA catheter interventions (P = 0.001 and P = 0.03). In this group, the minimal left PA diameter was smaller than that in the R-RV-PA group (P = 0.021). Leaving the shunt open until the Fontan operation increased the rate of PA interventions in the L-RV-PA group (P = 0.001), but there is no evidence of the impact on the development of the left PAs (P = 0.075). There is also no evidence that the type of the second-stage procedure influences the intervention rate before the Fontan procedure (P = 0.14). CONCLUSIONS: Children who have the L-RV-PA shunt require more PA catheter interventions. The right-sided RV-PA shunt and the subsequent Glenn anastomosis in the place of the shunt are associated with distortion-free and more symmetrical development of the central PAs.

Takotsubo Cardiomyopathy Complicating Percutaneous Pulmonary Valve Implantation in a Child.

Takotsubo cardiomyopathy describes a sudden onset cardiomyopathy with acute impairment of left ventricular function and spontaneous resolution over time. Only a few cases of Takotsubo cardiomyopathy in childhood have been described. We report the case of a 12-year-old girl with repaired tetralogy of Fallot who experienced acute onset of left ventricular dysfunction without coronary arterial involvement, suggesting Takotsubo cardiomyopathy, during an interventional catheterization procedure. Cardiogenic shock necessitated mechanical circulatory support with extracorporeal membrane oxygenator for ten days and mechanical ventilation for 12 days. The girl recovered without sequelae. Percutaneous pulmonary valve implantation was performed four months later without complications. Unusual aspects of this case include the use of mechanical circulatory support during the recovery phase of Takotsubo cardiomyopathy in a patient with congenital heart disease.

Motor outcome, executive functioning, and health-related quality of life of children, adolescents, and young adults after ventricular assist device and heart transplantation.

OBJECTIVE: The aim of the current study is to measure long-term executive function, motor outcome, and QoL in children, adolescents, and young adults after VAD and Htx. METHODS: Patients were examined during routine follow-up. Investigation tools were used as follows: Examination for MND of motor outcomes, Epitrack® for attention and executive functioning, and Kidscreen-52 and EQ-5D-5L questionnaires for QoL. Additional data were retrospectively obtained by an analysis of patient medical records. RESULTS: Out of 145 heart transplant recipients at the department of pediatric cardiology of the University Hospital Munich, 39 were implanted with a VAD between 1992 and 2016. Seventeen (43.6%) patients died before or after Htx; 22 (56.4%) patients were included in our study. Mean age at transplant was 9.52 years (range: 0.58-24.39 years, median 9), and the mean follow-up time after Htx was 6.18 years (range: 0.05-14.60 years, median 5.82). MND examination could be performed in 13 patients (normal MND: n = 11, simple MND: n = 1, complex MND: n = 1). Executive functioning was tested in 15 patients. Two (13.3%) patients had good results, six (40%) average results, three (20%) borderline results, and four (26.7%) impaired results. QoL (Kidscreen n = 7, EQ-5D-5L n = 8) was similar to a healthy German population. CONCLUSION: Motor outcome, executive functioning and QoL in survivors of VAD bridging therapy and Htx can be good, though underlying diseases and therapies are associated with a high risk of cerebral ischemic or hemorrhagic complications.

Von Willebrand factor parameters as potential biomarkers for disease activity and coronary artery lesion in patients with Kawasaki disease.

Elevated von Willebrand factor (vWF):Antigen plasma levels have been observed in conjunction with cardiovascular diseases or vasculitis. The association of Kawasaki disease, a vascular inflammatory disease and vWF:Antigen, vWF:Collagen binding activity, and vWF multimers is unknown. We therefore investigated vWF parameters in 28 patients with acute Kawasaki disease in association with disease activity and coronary artery lesions. VWF:Antigen and vWF:Collagen binding activity were assessed via enzyme-linked immunoassay. The ratio of both (vWF:Collagen binding activity and VWF:Antigen) was calculated and vWF multimeric structure analysis performed. We analyzed the association between vWF parameters and our clinical data focusing on coronary artery outcome. VWF:Antigen and vWF:Collagen binding activity levels were significantly higher in the acute than in the disease's convalescence phase, and correlated positively with CRP levels. Neither variable was associated with coronary artery lesions. The vWF:Collagen binding activity/vWF:Antigen ratio, however, was significantly decreased in patients with a coronary artery lesion (z-score > 2; N = 10; mean ratio 0.96 vs. 0.64; p = 0.031) and even more so in those with a coronary artery aneurysm (z-score > 2.5; N = 8; mean ratio 0.94 vs. 0.55; p = 0.02). In a sub-analysis, those patients with a very low ratio in the acute phase presented a persistent coronary artery aneurysm at their 1-year follow-up.Conclusion: This study suggests that comprehensive analysis of vWF parameters may help to both monitor KD inflammation and facilitate the identification of those patients carrying an increased risk for coronary artery lesion.What is Known:• Von Willebrand factor (VWF)-parameters represent surrogate markers for vascular inflammation.• Kawasaki disease is a generalized vasculitis in children, which can be complicated by coronary artery lesions.What is New:• In those Kawasaki disease patients with coronary artery lesions, the vWF:CB/vWF:Ag ratio was significantly decreased.• VWF parameters may help to identify patients at risk for coronary artery lesions.

Percutaneous closure of patent ductus arteriosus with the Nit-Occlud® patent ductus arteriosus device in 268 consecutive cases.

BACKGROUND: The pfm Nit-Occlud® patent ductus arteriosus (PDA) device is well established for interventional closure of PDA. However, there are still limited data concerning its efficacy and follow-up in larger patient groups. AIMS: This study aimed to evaluate the safety and efficacy of the Nit-Occlud® PDA device, implanted both through transpulmonary and transaortic approach, in a large cohort. METHODS: From July 2008 to December 2015, 268 consecutive patients were admitted for transcatheter closure of a PDA and were treated with the Nit-Occlud® coil. Clinical, echocardiographic, and angiographic data were evaluated. RESULTS: The median age was 5.2 years (range, 5 months to 62 years), and the median weight was 19.3 kg (range: 5.5-97 kg). Ten (3.7%) patients had weight <10 kg. The most common ductus types treated were Krichenko Type E and A (44.0% and 33.2%, respectively). Twelve (4.5%) patients were treated for residual shunting after surgical PDA closure. The median diameter at the narrowest point was 1.5 mm (range: 0.4-4 mm), the median size of the ampulla was 5 mm (range: 1-15 mm), and the median length was 9 mm (range: 2-25 mm). Device implantation could be successfully achieved in all cases. Closure rates documented immediately after the procedure, at 3-10 days, 1 month, and 6 months after intervention were 62%, 95.1%, 97.8%, and 98.5%, respectively. With the exception of one minor thromboembolic event, there were no procedure-related complications. CONCLUSION: Closure of PDA with various anatomic variations and sizes can be performed effectively and safely using the Nit-Occlud® coil.

Intermediate outcomes of transcatheter pulmonary valve replacement with the Edwards Sapien 3 valve - German experience.

Background: After encouraging results with the Edwards Sapien and XT valves, this study aimed to review procedural data and early outcomes for the Sapien 3 valves for transcatheter pulmonary valve replacement (TPVR). Methods: We performed a multicenter, retrospective analysis of cases who underwent a Sapien 3 TPVR between 2015 and 2017 in 7 centers in Germany with a follow-up of up to 2 years. Results: 56 patients could be enrolled (weight 58,5 ± 25,0 kg; 53% Tetralogy of Fallot, 45% native RVOT). Most procedures were two-stage procedures (82,1%) with 100% prestenting. Valve sizes were 20 mm (n = 1), 23 mm (n = 15), 26 mm (n = 27), 29 mm (n = 13). Procedural success rate was 96.4%. Two patients underwent surgical valve implantation after balloon rupture during TPVR. Follow-up data were available up to 24-month post TPVR. The rate of patients with ? moderate and severe pulmonary regurgitation decreased to 0% after TPVR, peak systolic gradient decreased from 24,2 (SD±20,9) mmHg to 7,1 mmHg (SD±5,0). There were no endocarditis, severe tricuspid valve impairment or stent fractures. Conclusions: With the Edwards Sapien 3 valve, the patient pool for TPVR can be substantially extended. Continued data collection is necessary to verify long-term results.

The standing of percutaneous pulmonary valve implantation compared to surgery in a non-preselected cohort with dysfunctional right ventricular outflow tract - Reasons for failure and contraindications.

BACKGROUND: Percutaneous pulmonary valve implantation (PPVI) numbers are rising but are still minor compared to surgery due to several contraindications. We sought to analyze the impact of PPVI compared to standard surgery in an unselected cohort with dysfunctional right ventricular outflow tract (RVOT). Reasons for PPVI failure and possible contraindications were explored. METHODS: Between 2010 and 2015 all consecutive patients who underwent surgery or intervention for a dysfunctional RVOT were investigated. RESULTS: A total of 382 cases was identified - 246 patients underwent successful valve insertion: 166 surgeries (166/246=67.4%) with 55/166 homografts (33.1%), 106 Contegra® grafts (63.8%), 5 Hancock valves (3.0%). Overall, 70/246 patients presented a priori with an enlarged RVOT>28mm (28.5%) not appropriate for PPVI and 14/246 (5.7%) had additional defects necessitating surgery. Some 31/246 patients had surgery for initial repair of congenital defects or were too small (<20kg) for PPVI (12.6%). 80 underwent successful PPVI (32.5% of 246 valves implanted) [51 Edwards Sapien® valves (63.7%), 29 Melody valves (36.3%)]. The RVOT was too large for PPVI in 22/246 patients (8.9%). A total 20/246 patients (8.1%) showed coronary compression after balloon interrogation. In 4/246 patients PPVI was not possible due to technical issues (1.4%). CONCLUSION: PPVI could be performed successfully in 80/382 patients (20.9%). An enlarged RVOT, small patient size, and coronary compression were the major obstacles for interventional management. Future developments for larger RVOTs and smaller body weight may expand the indication for PPVI.

The risk of infective endocarditis following interventional pulmonary valve implantation: A meta-analysis.

BACKGROUND: Interventional percutaneous pulmonary valve implantation (PPVI) was first reported in 2000. Today, two different valves are certified for this procedure [i.e. Medtronic Melody® valve (Medtronic, Dublin, Ireland) and Edwards Sapien™ valve (Edwards Lifesciences, Irvine, CA, USA)]. For a decade, studies have reported an increasing risk of infective endocarditis (IE) after PPVI; as patients for PPVI are usually younger, even a low annual incidence of IE is important. However, the overall incidence and potential differences between the valves remain unclear. METHODS: A systematic literature search was performed in the databases Medline, Cochrane Library, and Embase including the clinical trials register. The aim was to summarize and compare the cumulative incidence of IE after PPVI. Using a sensitivity analysis we set the incidence rates of the two valve types in ratio with a normal population. RESULTS: A total of 967 publications were identified searching for "pulmonary valve implantation," "PPVI," and 47 publications were used for final analysis. A total 3616 patients with Melody® valves and 501 with Sapien™ valves were included. IE after PPVI occurred in 214 patients with Melody® valves and in 5 patients only with Sapien™ valves. The pooled incidence for Melody® and Sapien™ valves was 4.9% (95% CI: 3.6-6.2) and 1.3% (95% CI: 0.3-2.3), respectively. Chi-square test was significant. The sensitivity analysis showed that the incidence rate ratio was 252.1 (95% CI: 187.6-338.6) for Melody® valves and for Sapien™ valves 2.7 (95% CI: 0.8-9.2). CONCLUSIONS: At present, there is an important difference for the risk of IE after PPVI. To reduce the risk of post PPVI endocarditis, a careful valve selection in favor of the Sapien™ valves seems to be beneficial.

The Creation of an Interatrial Right-To-Left Shunt in Patients with Severe, Irreversible Pulmonary Hypertension: Rationale, Devices, Outcomes.

PURPOSE OF THE REVIEW: Targeted pharmacotherapies did improve survival rates, exercise capacity, and quality of life (QoL) of PAH patients. However, these pharmacological interventions are expensive and not always accessible. In addition, not all patients do respond similarly to these medications and many will continue to deteriorate. This review aims to discuss the beneficial role of an artificial right-to-left shunt and highlights current interventional devices and outcomes. RECENT FINDINGS: Since patients with preexisting atrial shunts or patients with Eisenmenger's disease show better survival rates, improved exercise capacity, and QoL, PAH patients clinically do benefit from an atrial septostomy by reducing signs of right heart failure, improving left heart filling, cardiac output, and systemic oxygen transport despite hypoxia. However, an uncontrolled septostomy with unrestricted right-to-left shunt bears the risk of acute severe desaturation and death. The Atrial Flow Regulator (AFR device, Occlutech®, Sweden) provides an adjustable shunt size with restricted flow and excellent short-term outcomes. Interventional strategies for PAH palliation are on the rise. The novel AFR device provides a durable and safe option for a controlled right-to-left shunting, thus enabling an individualized management.

Edwards Sapien 3 transcatheter aortic valve implantation for management of severe aortic regurgitation in a teenage patient with corrected atrioventricular septal defect and progressive left ventricular dysfunction.

Transcatheter aortic valve replacement is mostly performed in elderly patients with severely calcified aortic valves. There are few reports about its use for pure aortic regurgitation, few reports about its use in adolescent patients and to the best of our knowledge no report about the use of an Edwards Sapien valve in the aortic position in an underage patient after surgically corrected congenital heart disease (CHD). Decompensation of a complex CHD can be difficult to manage and may require unusual solutions. We report a case of a teenage patient presenting with progressive aortic regurgitation and deterioration of left ventricular function after multiple surgical procedures for an atrioventricular septal defect (AVSD). As "bridge-to-transplant," we performed a transcatheter aortic valve implantation using a balloon-expandable Sapien 3 prosthesis. At 6 month follow-up, the patient remained clinically stable with no rehospitalization due to heart failure.

A feasibility study of a multimodal stimulation bioreactor for the conditioning of stem cell seeded cardiac patches via electrical impulses and pulsatile perfusion.

BACKGROUND/OBJECTIVE: Ischemic heart disease is a major cause of mortality worldwide. Myocardial tissue engineering aims to create transplantable units of myocardium for the treatment of myocardial necrosis caused by ischemic heart disease - bioreactors are used to condition these bioartificial tissues before application. METHODS: Our group developed a multimodal bioreactor consisting of a linear drive motor for pulsatile flow generation (500 ml/min) and an external pacemaker for electrical stimulation (10 mA, 3 V at 60 Hz) using LinMot-Talk Software to synchronize these modes of stimulation. Polyurethane scaffolds were seeded with 0.750 × 106 mesenchymal stem cells from umbilical cord tissue per cm2 and stimulated in our system for 72 h, then evaluated. RESULTS: After conditioning histology showed that the patches consisted of a cell multilayer surviving stimulation without major damage by the multimodal stimulation, scanning electron microscopy showed a confluent cell layer with no cell-cell interspaces visible. No cell viability issues could be identified via Syto9-Propidium Iodide staining. CONCLUSIONS: This bioreactor allows mechanical stimulation via pulsatile flow and electrical stimulation through a pacemaker. Our stem cell-polyurethane constructs displayed survival after conditioning. This system shows feasibility in preliminary tests.

Early outcomes of percutaneous pulmonary valve implantation using the Edwards SAPIEN 3 transcatheter heart valve system.

AIMS: Multiple surgical revisions are often necessary in individuals with congenital heart defects affecting the RVOT or pulmonary valve. There are no multicentre data on the feasibility and safety of percutaneous pulmonary valve implantation (PPVI) using the SAPIEN 3 (S3) transcatheter heart valve. The aim of this study was to explore the short-term safety, feasibility, and haemodynamic outcomes of PPVI using the S3 transcatheter heart valve. METHODS AND RESULTS: Pulmonic S3 is an observational registry of patients undergoing PPVI with the S3 valve across centres in Europe and Canada. Data for 82 patients (mean age 27.3 years) were obtained. The most common underlying diagnosis was tetralogy of Fallot (ToF) (58.5%), with 16.0% of patients having native RVOT anatomy; 90.2% received pre-stenting. Prosthesis dislodgement occurred in one patient and conduit perforation in another. Both were successfully resolved without the need for open surgery. Peak systolic gradient over the RVOT fell from 46.3 mmHg to 17.2 mmHg, moderate/severe pulmonary regurgitation from 86.3% to 0.0%, and NYHA ≥II from 86.0% to 15.2%. During follow-up, valve thrombosis was observed in two patients which resolved with adequate anticoagulation. No other procedural complications, endocarditis, stent fracture or death were reported within two years. CONCLUSIONS: PPVI with the S3 valve appears feasible and safe in a wide range of patients with congenital heart defects, with good short-term haemodynamic and functional outcomes.

The risk of bacterial endocarditis after percutaneous and surgical biological pulmonary valve implantation.

OBJECTIVE: This single center study compared the risk of bacterial endocarditis (BE) after surgical and percutaneous pulmonary valve implantation. METHODS: Between Jan 1st 2010 and Dec 31st 2015 all patients who received a biological pulmonary valve (surgical/interventional) were identified. The clinical follow-up was analyzed with regard to BE applying the modified Duke criteria and echocardiographic findings. RESULTS: We identified 246 patients who underwent a biological pulmonary valve implantation. The mean age was 15.9 years, (SD 12.7, Median 13.1). There were 166 surgical patients (67.5%), with 55 homografts (22.4%, mean diameter 27.4 mm), 106 Contegra® grafts (43.1%, mean diameter 17.4) and 5 Hancock® valves (2.0, mean diameter 25.6 mm) and 80 percutaneous pulmonary valve implantations (PPVI) (32.5%) with 51 Edwards Sapien® valves (20.7%, mean diameter 25.2 mm) and 29 Melody® valves (11.8%, mean diameter 21.9 mm). Patients with a bovione jugular conduit as the biologiocal substrate had an increased risk for BE and patients with Melody® valves had the highest risk for BE that was 5-8 times higher as compared to other valves. BE episodes were detected in 5/106 Contegras® (4,7%, 1.5 per 100 person-years), and in 6/29 of the Melody® valves (20.7%, 4.8 per 100 person-years). There were no cases of BE in patients treated with Edwards Sapien®, homografts or Hankock® valves. CONCLUSION: Whereas homografts and Edwards Sapien® valves seem to have a very low risk of BE, this risk is increased in Contegra® conduits and in Melody® valves.

Creation of a defined and stable Fontan fenestration with the new Occlutech Atrial Flow Regulator (AFR®).

This report describes the first clinical experience with the new Occlutech Atrial Flow Regulator (AFR®) device for implementation of a late Fontan fenestration. The AFR® device secured a defined diameter of the fenestration without spontaneous re-occlusion of this extra-anatomic perforation. This ensured a permanent clinical improvement of our failing Fontan patient.