Initial results of a prospective, multicenter study on the use of a biosynthesized cellulose membrane as a separation in de novo CIED implantations

Abstract Funding Acknowledgements Type of funding sources: Other. Main funding source(s): Public Grant: EIC Accelerator pilot –SME Instrument (H2020-EIC-SMEInst-2018-2020) Private Company: Hylomorph AG Background Fibrosis is the result of foreign body reaction against the hardware of cardiac implantable electronic devices (CIEDs). Generator pocket fibrotic adhesions increase the complexity and risks of CIED revision surgeries. There is limited evidence that synthetic or ex vivo resorbable envelopes can prevent or reduce fibrosis. Objective We conducted a multicenter, prospective, single-arm, interventional study of microengineered biosynthesized cellulose (BC) as separation layer for CIED pockets. Patients who were undergoing a CIED de novo implantation were included to receive the protective device. The primary end point was the maintenance of a detectable barrier between the CIED generator and the surrounding tissue at 12 months. The secondary end point for safety was procedure-related or system-related complications within 12 months. Methods High resolution ultrasound (HRUS) imaging of the protective layer, the CIED and the surrounding tissue of the generator pocket were collected at the day of implant, and at one, six-, and twelve-months follow-up visits in 35 patients (of 46 recruited). The images were individually processed and analyzed. Results HRUS imaging allowed the reproducible detection of (1) the CIED interface as fiducial reference marker, (2) the densification of the surrounding tissue and (3) the segregation between the two. A detectable separation between the CIED and the surrounding tissue was identified in all patients at all follow-up visits demonstrating the enforcement of a durable and stable barrier. The evolution of HRUS signal intensity indicated a time-dependent densification compatible with the buildup of fibrotic tissue around the generator. The thickness of this tissue was measured rendering values below 1 mm. Mean time for cellulose membrane application was 7.5±4 minutes. Investigational device related major complications were 0%. Conclusion Adjunctive use of an antifibrotic device established a durable separation between the CIED and the surrounding soft tissue in the generator pocket without a significantly higher incidence of complications or a relevantly increased procedural time. HRUS imaging indicated a limited buildup of denser tissue around the generator and no adhesions inside the cellulose membrane. Altogether these results suggest that BC may be beneficial for post-implantation pocket health as an alternative to envelopes of synthetic or animal origin and may enable easy pocket access in revision procedures.