RESUMO
BACKGROUND: Atrial septal defect (ASD) is one of the common congenital heart defects. Its management has transformed dramatically in the last 4 decades with the transition from surgical to percutaneous transcatheter closure for most secundum-type ASDs. Various devices are available for transcatheter closure of ASD with Amplatzer atrial septal occluder being most commonly used worldwide. Cocoon septal occlude has a nanocoating of platinum using nano-fusion technology over nitinol framework that imparts better radiopacity and excellent biocompatibility and prevents leaching of nickel into circulation, and by smoothening nitinol wire makes this device very soft and smooth. The aim of this study was to evaluate feasibility, effectiveness, safety, and long-term outcome of transcatheter closure of ASD using Cocoon septal occluder (Vascular Innovation, Thailand). RESULTS: All patients undergoing transcatheter closure of hemodynamically significant ASD between September 2012 and July 2019 in our institute were included into this single-center, prospective study. Exclusion criteria were defect > 40 mm, unsuitable anatomy, Eisenmenger syndrome, and anomalous pulmonary venous return. Three hundred and twenty patients underwent device closure, of which 238 (74%) were female. The mean age was 14.6 years (range 6-29), and the median weight was 30.2 kg (range 10-53 kg). Procedure was performed under fluoroscopy using transthoracic and transesophageal echocardiography in 298 (93.1%) and 22(6.9%) patients, respectively. Balloon-assisted technique was used, when septal defect was ≥ 34 mm, in 9 (2.8%) patients. The mean diameter of defect and device was 21.4 mm (range 12-36 mm) and 26.9 mm (range 14-40 mm), respectively. Aortic rim was absent in 11 (3.4%) patients. Primary success was achieved in 312 (97.5%) patients. Early embolization to right ventricle was noted in 2 (0.6%) patients. In both cases, 40-mm device was attempted for defect of 36 mm with inadequate aortic rim using balloon-assisted technique. One (0.3%) patient developed perforation of right atrium. All were surgically repaired. Three (0.9%) patients developed complete heart block following device deployment requiring device retrieval. Two patients had had moderate residual shunt at 6 months of follow-up. After mean follow-up of 50.92 months (range 12.5-89 months), no erosion, allergic reactions to nickel, or other major complications were reported. CONCLUSIONS: Percutaneous transcatheter closure of ASD by Cocoon septal occluder (up to 36 mm) is safe and feasible with high success rate and without any significant device-related major complications over long-term follow-up. With unique device design and excellent long-term safety, it could be preferred dual-disk occluder for transcatheter closure of atrial septal defect. In most of the patients, ASD device can be safely deployed under transthoracic echocardiographic guidance.
RESUMO
BACKGROUND: Temporary pacing is usually performed by cardiologists under fluoroscopic, echocardiographic, or ECG guidance. However, in the developing world, there are inadequate number of cardiologists, and C-arm, catheterization laboratories, or echocardiography are not available at primary or secondary healthcare facilities. In addition, in emergencies option of fluoroscopy and echocardiography is limited. So these patients are transferred to a facility where cardiologists and these facilities are available. Crucial time is lost in transit, which leads to increased mortality. In this study, we aimed to evaluate the safety, efficacy, and practicability of unguided temporary pacemaker insertion. RESULTS: A total of 1093 patients were enrolled in this study. After cannulating the internal jugular vein or subclavian vein, the pacing lead attached to the pulse generator was advanced blindly till ventricular pacing was achieved. Procedural success was taken as the primary endpoint. Secondary endpoints included the number of attempts taken for successful central venous puncture and procedural time. Complications and mortality were assessed for safety outcomes. Finally, the position of the pacing lead was assessed after the procedure on X-ray or fluoroscopy. The procedure was successful in all but one patient in whom a femoral vein approach was required because of brachiocephalic vein obstruction. Right internal jugular access was achieved in 981 (89.75%) patients. The mean number of attempts taken for achieving successful venous accesses was 1.54 ± 0.85; however, in 726 (66.42%) patients it was achieved in the first attempt. The mean procedural time was 11.5 ± 2.1 min. Overall, 117 (10.70%) patients developed complications; however, most of them were minor. Pneumothorax developed in 12 (1.1%) patients, of whom 2 needed an intercostal tube. Pericardial effusion was seen in 21 (1.92%) patients. Pacing lead tip was located in the right ventricular cavity abutting interventricular septum or free wall in 843 (77.20%) patients. No mortality attributable to procedure occurred. CONCLUSIONS: Unguided temporary pacing via jugular or subclavian venous approach in an emergency setting is possible with high success and a low complication rate. Thus, it is a safe and effective procedure, and clinicians working at primary and secondary healthcare levels should be encouraged to perform this procedure. Trial registration UMIN Clinical Trials Registry, UMIN000046771. Registered 28 January 2022-Retrospectively registered, https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053348.
