Safety and Performance of a Self-Assembling Peptide Haemostat for the Management of Bleeding after Left Ventricular Assist Device Implantation: Outcomes of a Post Market Clinical Follow-Up Study

Abstract

Purpose Control of bleeding represents a challenge during LVAD implantation. We report the results of a PMCF study using a novel self-assembling peptide hydrogel (PuraStat®) as a resorbable haemostat. Methods A prospective, single-centre, single arm cohort study was conducted to confirm feasibility and safety of PuraStat in a complex cardiac procedure. Patients over the age of 18 years admitted for primary implantation of a LVAD and who gave written informed consent were enrolled and treated with PuraStat following primary hemostasis with persistent oozing bleeding. During LVAD implantation the apical cannulation and outflow graft anastomosis sites were treated with PuraStat. Patients were followed for 12 hours after operation, and in case of re-operation for any reason, such as heart transplantation or LVAD explant, within 24 months after implantation. We measured time to haemostasis as primary end point with secondary endpoints relating to safety and ease of use. Results Sixteen patients were enrolled at one institution in Germany between March and August 2015. In one patient PuraStat has not been used so only 15 patients were included in the performance analysis and 29 surgical bleeding sites treated with PuraStat formed the basis for the study analysis per Table 1. Conclusion Device performance was demonstrated by a short reported total time to haemostasis, absence of unexpected tissue response at re-operation (inflammation, foreign body reaction, excessive granulation) and no device related AEs or SAEs through 24 months.