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Objectives This study sought to investigate patient intermediate-term outcomes after transcatheter pulmonary valve replacement (TPVR) with Edwards SAPIEN valve. Background The Edwards SAPIEN valve, initially designed for percutaneous aortic valve replacement, has been approved for TPVR in patients with dysfunctional right ventricular outflow tracts (RVOT), but only short-term follow-up has been reported. Methods From 2011 to 2016, 62 patients undergoing successful TPVR using the SAPIEN XT valve were consecutively included into the study. Primary efficacy and safety endpoints were defined as freedom from valve-reintervention and freedom from infective endocarditis at last follow-up, respectively. Results The primary efficacy outcome was met for 87.1% patients after a mean follow-up of 4.6 ± 1.8 years, corresponding to a freedom of reintervention at 5 years of 89% (95% CI 74.8-95.6%). Reinterventions were exclusively due to recurrent obstruction, no significant valvular regurgitation was observed. One case of infective endocarditis was reported, corresponding to a rate of 0.35% per patient-year (95% CI 0.01-2.00%). At 5 years, freedom from infective endocarditis was 98.4% (95% CI 89.1-99.8%). Six patients died or were transplanted due to advanced cardiac failure, without relationship with TPVR. In univariate analysis, reintervention was associated with young age, a smaller tube-graft, a higher pulmonary valve gradient after the procedure and a ratio of largest implanted stent diameter to invasive balloon conduit diameter over 1.35. Conclusions This study documents the mid-term safety and efficacy of the Edwards SAPIEN XT valve in patients with dysfunctional RVOT, and identifies a patient profile associated with an uncertain benefit-risk balance.

We report a case of antegrade transcatheter occlusion of a paravalvular leak (PVL) after bioprosthetic pulmonary valve replacement in a 31-year-old patient with tetralogy of Fallot. The leak resulted in severe pulmonary regurgitation with right ventricle volume overload. This case is the first-ever report of a successful percutaneous closure of PVL using the Occlutech paravalvular leak device.

BackgroundThe Occlutech Figulla ASD device series (OFSO) shows an improved device design for interventional ASD closure, larger follow-up series are missing. MethodsWe retrospectively reviewed the feasibility, safety, implantation properties, results, and follow-up of ASD closure using Occlutech devices over a 5 year period by establishing a multi-institutional collaborative result registry with 16 contributing centers from 11 countries (IRFACODE). ResultsIn 1315 patients of all age groups (female 66.9%), successful (98%) ASD closure was performed (mean age 28.9 years, weight 52 kg, height 148.6 cm). Of the defects, 47.9% showed no or only a deficient aortic rim;in 11.9%, there was more than one defect;a septum aneurysm was present in 21.5%;and the mean implanted device size was 20.5 mm. Immediate closure was achieved in 78.6%, at discharge in 83.1%, and 96.4% and 97.3% at 6 and 12 months follow-up, respectively. During a mean follow-up of 2.7 years (in total 3597 patient years), significant complications were minimal (total=8

Objectives The short-term efficacy and safety of transcatheter closure (TCC) for the management of coronary artery fistulas (CAFs) was investigated in pediatric patients. Background CAFS are rare with potentially severe complications and their management is still a matter of debate. Percutaneous closure appears to be the treatment of choice in anatomically suitable vessels but limited data are available in the pediatric population. Methods This retrospective, observational, multicenter, national study included patients under 16 years of age who underwent TCC of a congenital CAF. Patients with additional congenital heart defect were excluded. Results 61 patients (36 girls, 25 boys) with a median age of 0.6 year [0–15.4] at diagnosis and 3.9 years [0–16] at procedure were included. The CAF was large in 48 patients (79%); it was distal in 23 (38%) and proximal in 22 (36%). Most patients (77%) were asymptomatic at diagnosis. Clinical signs of congestive heart failure were present in seven patients (11%). Perioperative complications included three cases of ST elevation myocardial infarction (exclusively during attempted closure of a distal CAF), three devices migrations, and one case of leg ischemia. One patient died after surgical closure of a large distal CAF that could not be closed by TCC. Follow-up data were collected for 43 patients (70%) for a median of 91 days [0–4,824]. The Kaplan-Meyer estimate for complete occlusion at 2 years was 73 ± 7.6%. Conclusion TCC in the pediatric population appears to be effective and associated with few complications. © 2015 Wiley Periodicals, Inc.

In interventional magnetic resonance imaging (MRI), the systems designed to help the surgeon during biopsy must provide accurate knowledge of the positions of the target and also the entry point of the needle on the skin of the patient. In some cases, this needle entry point can be outside the B(0) homogeneity area, where the distortions may be larger than a few millimeters. In that case, major correction for geometric deformation must be performed. Moreover, the use of markers to highlight the needle entry point is inaccurate. The aim of this study was to establish a three-dimensional coordinate correction according to the position of the entry point of the needle. We also describe a 2-degree of freedom electromechanical device that is used to determine the needle entry point on the patient's skin with a laser spot.

The purpose of this study was to assess the feasibility of magnetic resonance (MR)-guided balloon angioplasty of a stenosed aorta on an open low-field magnet using a passive tracking technique. Visualization of vessels and position of instruments were realized by using a fast low-angle shot (FLASH) sequence. Catheters and guidewire were prepared for susceptibility-based MR visualization. Standard balloon catheters were inflated with diluted gadolinium, and nitinol guidewires were modified by incorporation of iron oxide markers into their walls. After validation on a flow phantom, balloon angioplasty was performed on an in vivo model of arterial stenosis. Creation of abdominal aorta stenosis was realized in five piglets. MR-guided balloon angioplasty of the aorta was performed with success in all but one. In one of them, stent implantation was achieved in the descending aorta. Balloon angioplasty using a passive tracking technique is a simple concept that can be realized with near-standard instruments and any MR imaging system. This represents an advance toward MR-guided vascular interventions in the future.