Feasibility of a novel, synthetic, self-assembling peptide for suture-line haemostasis in cardiac surgery

Abstract

Backgroud: To assess the feasibility and efficacy of PuraStat®, a novel haemostatic agent, in achieving suture line haemostasis in a wide range of cardiac surgical procedures and surgery of the thoracic aorta. Methods: A prospective, non-randomised study was conducted at our institution. Operative data on fifty consecutive patients undergoing cardiac surgery where PuraStat® was utilised in cases of intraoperative suture line bleeding was prospectively collected. Questionnaires encompassing multiple aspects of the ease of use and efficacy of PuraStat® were completed by ten surgeons (five consultants and five senior registrars) and analysed to gauge the performance of the product. Results: No major adverse cardiac events were reported in this cohort. Complications such as atrial fibrillation, pacemaker requirement and pleural effusions were comparable to the national average. Mean blood product use of packed red cells, platelets, fresh-frozen plasma (FFP) and cryoprecipitate was below the national average. There was one incidence of re-exploration, however this was due to pericardial constriction rather than bleeding. Analysis of questionnaire responses revealed that surgeons consistently rated PuraStat® highly (between a score of 7 and 10 in the various subcategories). The transparent nature or PuraStat® allowed unobscured visualisation of suture sites and possessed excellent qualities in terms of adherence to site of application. The application of PuraStat® did not interfere with the use of other haemostatic agents or manipulation of the suture site by the surgeon. Conclusion: PuraStat® is an easy-to-use and effective haemostatic agent in a wide range of cardiac and aortic surgical procedures.