Interventional VSD-Closure with the Nit-Occlud® Lê VSD-Coil in 110 Patients: Early and Midterm Results of the EUREVECO-Registry.

In August 2010, the Nit-Occlud® Lê (EUREVECO) became available for transcatheter coil occlusion of ventricular septal defects (VSDs). Retrospective European Registry for VSD Closure using the Nit-Occlud® Lê-VSD-Coil; analysis of the feasibility, results, safety and follow-up of VSD-closure over a 3-year period in 18 European centers. In 102 of 111 patients (female 66), successful VSD closure was performed (mean age 8.2 years, mean weight 28.82 kg), 81 perimembranous VSDs (48 with aneurysm), 30 muscular VSDs, mean procedure time was 121.1 min, and mean fluoroscopy time was 26.3 min. Short- and midterm term follow-up was possible in 100/102 patients, there was 1 embolization and 1 explantation after 24 months. Immediate complete closure occurred in 49 of 101 patients (48.5%), trivial residual shunt was present in 51 (50.0%), closure rate was 95% after 6 months and 97% after 1 year. Out of the 102 patients, there were 2 severe complications (1.8%) (1 severe hemolysis, 1 embolization) and 8 moderate/transient (=7.2%) including 1 transient AV block. During a mean follow-up period of 31.3 months (range 24-48) and a total follow-up time of 224.75 patient years, no further problems occurred. VSD closure with the Nit-Occlud® Lê VSD coil is feasible and safe with a minimal risk of severe side effects. The long-term effects and safety require further clinical follow-up studies.

Closure of Secundum Atrial Septal Defects by Using the Occlutech Occluder Devices in More Than 1300 Patients: The IRFACODE Project: A Retrospective Case Series.

BACKGROUND: The Occlutech Figulla ASD device series (OFSO) shows an improved device design for interventional ASD closure, larger follow-up series are missing. METHODS: We 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). RESULTS: In 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, <1%) with secondary device embolizations in five and AV-blocks in three patients. No erosion or death was reported. CONCLUSION: ASD closure using OFSO is feasible in a large variety of patients, safe with only a minimal risk of severe side effects and especially without any aortic erosions despite a large percentage of large and complicated defects. © 2016 Wiley Periodicals, Inc.

A single-center experience in the use of hybrid techniques for thoracic aortic pathology.

The hybrid method of treating thoracic aortic pathology is devoid of the disadvantages of traditional open surgery and, at the same time, has a broader range of applications than the endovascular method. From 2014 to 2019, we researched 122 patients with thoracic aortic pathology treated with the hybrid method (open surgery with thoracic endovascular aortic repair (TEVAR) at the National M. Amosov Institute of Cardiovascular Surgery National Academy of Medical Science of Ukraine. In the general group, 34 patients had a descending aortic aneurysm without dissection or rupture; 71 patients had an aortic dissection (10 - acute, 9 - subacute, 52 - chronic), penetrating aortic ulcer (PAU) - 7, thoracoabdominal aneurysm (Crawford I-II) - 4, isolated aortic arch aneurysm - 2, residual enlargement aorta after previous ascending aortic grafting causing type A acute aortic dissection (TAAD) - 3, primary aortic thrombosis - 1. Patients admitted as elective surgery candidates had switched aortic arch vessels (debranching) in the first stage and TEVAR in the second stage. For emergencies (aortic rupture with uncontrolled bleeding, malperfusion syndrome), TEVAR operation was performed first. Long-term results of treatment after three and six months are satisfactory. The hybrid technique of aortic arch treatment using modern minimally invasive technologies can eliminate the pathology in the most dangerous segment of the main artery of the body, providing a reasonable level of hospital mortality - 4.2%, and a small number of neurological complications.

Medium- and long-term follow-up of transcatheter closure of ruptured sinus of Valsalva aneurysm in Central Europe population.

BACKGROUND: We aimed to evaluate medium- and long-term outcomes of transcatheter closure (TC) of ruptured sinus of Valsalva aneurysm (RSVA), which is a rare and mostly congenital heart disease. METHODS: Retrospective analysis included 23 patients (14 males) aged 15-79 years (y; 39.9±18.5) selected for TC of RSVA between 2007 and 2017 in two tertiary centers in Poland and Ukraine. Fifteen patients were in New York Heart Association (NYHA) class III or IV before TC; 5 patients had acquired RSVA after previous cardiac surgery. We applied 22 duct, 3 muscular, and 1 atrial septal Amplatzer or Amplatzer-like occluders by the anterograde venous approach after arterio-venous loop creation in all but 1 patient. Mean follow-up conducted in outpatient clinic was 5.5±3.5 (1-11)y. RESULTS: The procedure was successful in 19/23 patients (82.6%). Four procedures were abandoned and the device percutaneously retrieved due to coronary artery compression (1 patient), transient increase of aortic regurgitation (AR; 1 patients) or embolization (2 patients). New onset of significant AR was noted in one of the latter patients after device removal. NYHA class improved in all treated patients but 2, in whom it remained stable (p<0.05), with 10 patients in class I. Three patients needed percutaneous re-intervention during follow-up because of significant residual shunt in 1 and late recurrent RSVA in 2 patients. The follow-up of the remaining patients was uneventful. Neither erosion, embolization, new AR, nor death were observed. CONCLUSIONS: The percutaneous closure of RSVA is a safe and effective method of treatment with good clinical outcome. However, although not described previously, recurrent shunts after TC of RSVA are possible and can be treated successfully with another transcatheter intervention.