The new Occlutech® PDA occluder: Initial human experience

Abstract

Objectives: To evaluate the feasibility, safety, and efficacy of the Occlutech V R PDA occluder for closure of patent ductus arteriosus (PDA). Background: The Occlutech V R PDA occluder is novel, self-shaping Nitinol wire device with PET (polyethylene terephthalate) patches integrated into the shank of the device to assure a better obturation of the ductus. The Occlutech V R PDA occluder has undergone two design modifications. Methods: A prospective, non-randomized pilot study was started in November 2011. Thirty-three patients were included until April 2013. Patients weighing <6 kg or those with associated cardiac anomalies that required surgery were excluded. All patients were followed up by transthoracic echocardiography at 24 hr, 30 days, 90 days, 180 days, and 360 days after implantation. Residual shunt, left pulmonary artery (LPA) and descending aortic velocities were among the parameters assessed. All occluders were delivered via 6-8 F long sheaths and PDA closures were performed following standard techniques. Results: Thirty three patients (20 female/13 male), with a median age of 2 years (6 month to 38 years), and median weight of 9.3 kg (6-69.2 kg) were included. The narrowest median PDA diameter was 3mm (1.8-5.8 mm). All the 33 patients were closed successfully using Occlutech ductal occluder, 16 patients (48.4%) had immediate and complete closure on angiography. Within 24 hr, color Doppler revealed complete closure in 27patients (81.8%), 32patients (97%) at 30 days, and in 100% of patients at 90 days. All patients with a large PDA had immediate residual shunt which was closed at the 90-day follow-up. There was no device embolization, hemolysis, or obstruction to the LPA or descending aorta. Conclusion: The new Occlutech V R PDA is safe and effective. In patients with a large PDA complete closure tended to take longer time.

Short‐Term Outcomes of Patent Ductus Arteriosus Closure With New Occlutech® Duct Occluder: A Multicenter Study

“…Kudumula et al reported that ductal occlusion did not occur immediately in patients who underwent transcatheter closure of PDA using the ODO . Also, Abdelbasit et al indicated 48.5% complete occlusion rate at 10 minutes post‐implant, they stated patients having large PDAs tend to have residual shunt but it achieves complete closure about 90 days . According to our data, complete occlusion at the end of procedure was achieved only in 63% of the patients supporting the results of Kudumula et al Despite the differences in early occlusion rates, final occlusion rates are similar with ADO‐I.…”

The Occlutech Duct Occluder for Patent Ductus Arteriosus

“…Reported case series in the literature confirm the high occlusive properties of the ODO, even though larger ducts usually require more time to close [8,9]. Our present results demonstrate a 100% success rate (shunt closure and successful implantation) with zero mortality and no serious morbidity.…”

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

“…A size difference of 1 mm resulted in an appropriate device stability in contrast to 3–4 mm oversizing that were necessary in their experience with previous devices . Boudjemline et al and Abdelbasit et al, who are also reporting their initial experience with the Occlutech ® PDA Occluder implanted the 8/10 mm device maximum as well . In our study with large PDA > 5 mm and additional PAH the maximum available device size was used (14/18) twice (Table ).…”

“…The interventionalist's armamentarium nowadays consists of a wide range of various occluder types and coils, mostly nitinol‐based and self‐expanding . The closing procedure itself is considered a standard procedure in most pediatric cath labs with excellent results . However, closure of PDA with very large diameters (PDA/Ao ratio > 0.5) still remains a complex challenge, especially when an elevated pulmonary artery pressure is present .…”