The occlutech duct occluder: How to choose the correct device size and refine implantation technique to ensure optimal results in small and large arterial duct closure

Abstract

Background: Previous studies on the Occlutech Duct Occluder (ODO) have established the safety and efficacy of duct occlusion in small patient cohorts, without clearly defining the technique required for successful device implantation. The objective of this study was to describe in detail how to size and implant the device, evaluating the proposed technique in a large patient cohort, including patients with large ducts (≥4 mm). Methods and findings: Transcatheter arterial duct (PDA) occlusion was attempted in 166 successive patients with a PDA ≥ 1 mm diameter. For PDAs<4 mm, the ODO was oversized by 1-2 mm. For PDAs ≥ 4 mm, the ODO was oversized by 2-4 mm. The device was deployed with light pressure and angiography was used to demonstrate its position. Intention to treat and as treated procedural success rates were 159/166 (96%) and 159/161 (99%). Success rates were 71/73 (97%) and 72/73 (99%) in patients with large ducts. All implants achieved complete PDA occlusion by the following day. At median follow up of 10.6 (range 1.6-13.1) months echocardiography showed no residual shunts. One device embolised immediately and was successfully retrieved by snaring. Devices were median 1.9 (range 1.1-5.2) mm larger than ducts<4 mm and median 3.3 (0.9-6.4) mm larger than ducts ≥ 4 mm. In 46/89 (52%) ducts<4 mm the device was oversized by only 1 mm. Conclusion: Safe and effective occlusion is achieved when the ODO is oversized by 1-2 mm in ducts<4 mm in diameter and 2-4 mm in ducts ≥ 4 mm in diameter. The majority of ducts<4 mm in diameter can be safely occluded with a device oversized by only 1 mm. Correct device position can be determined angiographically, without regard to compression of the device within the duct. The device and techniques are equally safe and effective for large ducts.