Outcomes of transcatheter pulmonary SAPIEN 3 valve implantation: an international registry.

BACKGROUND AND AIMS: Transcatheter pulmonary valve implantation (TPVI) is indicated to treat right-ventricular outflow tract (RVOT) dysfunction related to congenital heart disease (CHD). Outcomes of TPVI with the SAPIEN 3 valve that are insufficiently documented were investigated in the EUROPULMS3 registry of SAPIEN 3-TPVI. METHODS: Patient-related, procedural, and follow-up outcome data were retrospectively assessed in this observational cohort from 35 centres in 15 countries. RESULTS: Data for 840 consecutive patients treated in 2014-2021 at a median age of 29.2 (19.0-41.6) years were obtained. The most common diagnosis was conotruncal defect (70.5%), with a native or patched RVOT in 50.7% of all patients. Valve sizes were 20, 23, 26, and 29 mm in 0.4%, 25.5%, 32.1%, and 42.0% of patients, respectively. Valve implantation was successful in 98.5% [95% confidence interval (CI), 97.4%-99.2%] of patients. Median follow-up was 20.3 (7.1-38.4) months. Eight patients experienced infective endocarditis; 11 required pulmonary valve replacement, with a lower incidence for larger valves (P = .009), and four experienced pulmonary valve thrombosis, including one who died and three who recovered with anticoagulation. Cumulative incidences (95%CI) 1, 3, and 6 years after TPVI were as follows: infective endocarditis, 0.5% (0.0%-1.0%), 0.9% (0.2%-1.6%), and 3.8% (0.0%-8.4%); pulmonary valve replacement, 0.4% (0.0%-0.8%), 1.3% (0.2%-2.4%), and 8.0% (1.2%-14.8%); and pulmonary valve thrombosis, 0.4% (0.0%-0.9%), 0.7% (0.0%-1.3%), and 0.7% (0.0%-1.3%), respectively. CONCLUSIONS: Outcomes of SAPIEN 3 TPVI were favourable in patients with CHD, half of whom had native or patched RVOTs.

Percutaneous pulmonary valve implantation in children and adults with an age and gender-specific analysis.

BACKGROUND: There are limited studies with medium-term follow-up following percutaneous pulmonary valve implantation and no studies with a gender-specific analysis. AIMS: To report clinical outcomes up to five years following percutaneous pulmonary valve implantation using the two most common balloon expandable valves in a mixed population of paediatric and adult patients with an age and gender-specific analysis. METHODS: This was a single-centre retrospective observation study. Relevant data were obtained retrospectively from the case files. Age and gender- specific analysis was performed using SPSS. RESULTS: Totally, 58 patients (13 children, 45 adults) underwent percutaneous pulmonary valve implantation. Statistically significant reduction in median right ventricular outflow tract flow velocity following valve implantation was maintained for the whole five years in adults but not in children. There were no gender-specific differences despite the study being adequately powered. Independent of valve type used, there was significant reduction of the right ventricular outflow tract flow velocity in the immediate post valve implantation period (Edwards P = 0.001, Melody P = 0.013). There was a significant negative correlation between implanted valve Z-score and subsequent right ventricular outflow tract gradient during the first two years following valve implantation. CONCLUSION: Gender does not significantly affect valve function following percutaneous pulmonary valve implantation. It is important to consider patients' age and body surface area in relation to existing right ventricular outflow tract size during decisions for percutaneous pulmonary valve implantation.

Edwards Sapien XT® pulmonic valve compression after resuscitation and successful redilatation.

Despite the increasing use of percutaenous valves, little is known about valve performance after external chest compression. We report a case of a compressed pulmonary Edwards Sapien® XT valve after resuscitation. With the patient on ECMO, successful redilatation was performed with unimpaired postprocedural valve function. We aim to increase the awareness for valve distortion after external chest compression with increasing numbers of transcatheter valvulations. We suggest that immediate re-evaluation of the implanted device via biplane fluoroscopy is mandatory after resuscitation in such cases.

Is mesocardia with left-sided caval vein draining to coronary sinus a contraindication for a percutaneous pulmonary valve implantation? A case description.

Introduction Although the right jugular vein approach for percutaneous pulmonary valve implantation is well described, there are no reports that describe a percutaneous pulmonary valve implantation through a left superior caval vein to coronary sinus pathway. Case A 14-year-old female with tetralogy of Fallot, mesocardia, left superior caval vein draining into the coronary sinus, and hemiazygos continuation of the inferior caval vein underwent ventricular septal defect closure, with homograft insertion from the right ventricle to the pulmonary artery, patch augmentation of the left pulmonary artery, and creation of an atrial communication. Thereafter followed numerous catheterisations and interventions with stent implantation for stenosis of the left pulmonary artery and the homograft, as did device closure of the atrial communication. When she was a 12-year-old, the indications for a percutaneous pulmonary valve implantation were fulfilled and she underwent implantation of a 22 mm Melody® valve through the left superior caval vein. The extra-stiff exchange wire was pre-formed into a "U-spiral"-type configuration, according to the underlying anatomy, in order to provide a smooth route for the delivery of stents, to create the landing zone, and for the implantation of the Melody "ensemble". The procedure was performed under deep sedation according to our standard protocol. The duration of the procedure was 172 min and the radiation time was 24.9 min. CONCLUSION: On the basis of this unique experience, percutaneous pulmonary valve implantation is safe and feasible even in patients with unusual anatomy. Crucial is the "U-spiral" shaped configuration of the guide wire.

Closure of very large PDA with pulmonary hypertension: Initial clinical case-series with the new Occlutech® PDA occluder.

OBJECTIVE: We report our recent experience with the new Occlutech® PDA Occluder, which seems suitable especially for closure of large patent ductus arteriosus (PDA) sizes with elevated pulmonary artery pressure (PAH). BACKGROUND: Although considered a standard procedure in pediatric cath labs, closure of very large PDA (PDA/Aorta ratio > 0.5) and PAH remains a challenge. METHODS/RESULTS: The Occlutech® PDA occluder was used in eight children and adolescents (age 4-16, median 10.75 years), body weight from 14 to 54 kg (median 21 kg) with very large PDA and PAH: PDA diameter was 5-13 mm (median 10 mm); PAP/Aortic pressure ratio was 0.58-0.96. Sufficient occlusion of the PDA was documented by angiography and/or echocardiography in all cases. Four different device sizes were selected: Minimal diameter 6-14 mm (median 12 mm), length 6.3-16 mm (median 14 mm), aortic disc 13-24 mm (median 20 mm), size at the pulmonary end 8-18 mm (median 15 mm). A balloon test occlusion of the PDA was performed in five patients in order to evaulate the decline of pulmonary artery pressure or to delineate the exact anatomy of the PDA. Before release of the device, a careful "wiggle manoevre" was performed to assess the stability of the implanted device and to proof the inability to embolize to the aorta. CONCLUSIONS: With the new Occlutech® PDA Occluder closure of very large PDAs and PAH is feasible and efficient. The wider pulmonary artery end of the Occlutech® PDA Occluder offers enhanced stability and reduces the risk of embolization. © 2016 Wiley Periodicals, Inc.

The "Dog Bone Technique" A Novel Easy and Safe Catheter Maneuver for Aortic Arch and Coarctation Stenting.

BACKGROUND: Various techniques are described to facilitate stable stent implantation in aortic arch stenosis or coarctation. We describe an alternative technique, which due to its unique appearance during stent implantation, we have named "Dog Bone Technique" (DBT). TECHNIQUE: The stent/balloon assembly is placed across the stenosis, the long sheath is retrieved to uncover the distal 20-50% of the stent. The balloon is inflated with the pressure inflator just to expand slightly the stent. Thereafter the sheath is pulled back and the proximal end is uncovered and partially inflated; therewith the assembly takes the typical "dog bone" shape before complete inflation and final positioning. Repositioning of the stent and control angiography is possible at each time of this procedure. RESULTS: Between 1/2010 and 12/2014 we implanted 91 stents in 87 patients (mean age 20.2 years). About 71 patients had native or re-coarctation and 16 patients had transverse aortic arch stenosis. In 38 patients (44%) a pharmacological exercise test with Orciprenaline was performed during implantation resulting in high-cardiac output. In none of the patients reduction of cardiac output by adenosine or a rapid pacing of the right ventricle was required for stable stent implantation. All stents were implanted in the targeted position using this single balloon technique. There were no acute or short-term complications detected. CONCLUSION: DBT is a safe and feasible technique for aortic stent implantation even at high-cardiac output. Other additional techniques for stent placement are not necessary to obtain a stable final position in the target region.

Cardiac Muscle Training-A New Way of Recognizing and Supporting Recovery for LVAD Patients in the Pediatric Population.

Patients with refractory heart failure due to chronic progressive cardiac myopathy (CM) may require mechanical circulatory support as a bridge to transplantation. A few patients can be weaned from support devices if recovery can be achieved. The identification of these patients is of great importance as recovery may be missed if the heart is unloaded by the ventricular assist device (VAD). Testing the load-bearing capacity of the supported left ventricle (LV) by temporarily and gradually reducing mechanical support during cardiac exercise can help identify responders and potentially aid the recovery process. An exercise training protocol was used in 3 patients (8 months, 18 months and 8 years old) with histological CM findings and myocarditis. They were monitored regularly using clinical information and functional imaging with VAD support. Echocardiographic examination included both conventional real-time 3D echocardiography (RT3DE) and speckle tracking (ST). A daily temporary reduction in pump rate (phase A) was followed by a permanent reduction in rate (phase B). Finally, pump stops of up to 30 min were performed once a week (phase C). The final decision on explantation was based on at least three pump stops. Two patients were weaned and successfully removed from the VAD. One of them was diagnosed with acute viral myocarditis. The other had chronic myocarditis with dilated myopathy and mild interstitial fibrosis. The noninvasive assessment of cardiac output and strain under different loading conditions during VAD therapy is feasible and helps identify candidates for weaning despite severe histological findings. The presented protocol, which incorporates new echocardiographic techniques for determining volume and deformation, can be of great help in positively guiding the process of individual recovery, which may be essential for selecting and increasing the number of patients to be weaned from VAD.

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.

"Intraoperative hybrid stenting of recurrent coarctation and arch hypoplasia with large stents in patients with univentricular hearts".

BACKGROUND: Obstruction of the reconstructed aortic arch, tubular hypoplasia and recurrent coarctation (RC) is an important risk factor in univentricular physiology. For the past two years we have adopted the concept of intraoperative hybrid stenting of RC and arch hypoplasia with large stents in patients with univentricular hearts as standard care procedure. METHOD/RESULT: Retrospective analysis of the anatomy and procedural outcome of 14 patients was scheduled for intraoperative stenting of the aortic arch (12 during surgery for BCPS, 2 during Fontan completion). The median age was 5.3 months, weight 5.5 kg, height 62 cm. Five patients had tubular hypoplasia and 9 patients had distal stenosis of the aortic arch. Nine patients had a previous balloon dilatation. The mean diameter of the distal arch was 11.0mm, at the coarctation 5.1mm, at the level of the diaphragm 8.2mm (CoA-index 0.62). Intraoperative stenting was performed in 13/14 patients. Stents were implanted with a mean balloon diameter of 10.8mm (SD 3.4mm). The achieved final mean diameter was 9.8mm (mean, SD 2.8mm) with an oversized Coa-index of 1.2. There was no re-coarctation at a mean follow-up of 7.3 months (range 3 to 24), the maximum flow velocity of 2m/s across the stented lesion assessed by ECHO. CONCLUSION: This hybrid approach is an easy and safe concept to manage recurrent aortic arch hypoplasia and stenosis. The use of large stents allows redilatation to adult size diameters later on.

Low bacterial count urinary tract infections in infants and young children.

UNLABELLED: The purpose of the study was to compare bacterial species, clinical, laboratory and imaging findings ((99m )Tc-dimercaptosuccinic acid renal scan and voiding cystogram) in infants and children with high (>/=10(5) colony forming units (CFU)/ml, group A patients) and low (