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

Abstract

BackgroudTo 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.MethodsA 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.ResultsNo 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.ConclusionPuraStat® is an easy-to-use and effective haemostatic agent in a wide range of cardiac and aortic surgical procedures.

Haemostasis and prevention of bleeding related to ER: The role of a novel self‐assembling peptide

“…PuraStat® is a novel agent with haemostatic properties. It has been used in cardiovascular surgery 6 , 7 and in small ESD series 5 with promising results.…”

Designer Self‐Assembling Peptide Hydrogels to Engineer 3D Cell Microenvironments for Cell Constructs Formation and Precise Oncology Remodeling in Ovarian Cancer

“…For examples, Purastat hydrogel is recently licensed for clinical hemostatic nanomaterials in endoscopic resection (ER) surgery [ 59 ] and suture‐line hemostasis in cardiac surgery. [ 60 ] The surgeons consistently rate Purastat hydrogel highly, due to the transparent nature and convenient manipulation of the suture site. In chemically synthetic RADA16‐I peptide hydrogels, 3D peptide nanofiber networks are formed by efficient molecular self‐assembly of ionic self‐complementary hexadecapeptide in a pattern of four repeats of four amino acid residues, [ 23b ] which not only avoid immunogenicity in human clinic applications but also spontaneously and rapidly form the entangled nanofiber networks without chemical cross‐link reactions and additional components, we suppose that it is a type of precise synthetic nanomaterials that the peptide nanofibers with diameter of about 10–20 nm and maximum length of 500 nm are akin to the native ECM iv vivo.…”

“…[ 67 ] G) Instantly produced PuraMatrix hydrogel‐MSC complex is an advanced cell construct for innovative therapy in rat heart failure models, [ 85 ] since the feasibility and efficacy of Purastat hydrogel achieves the clinical approval in suture line hemostasis. [ 60 ] Panels (A–G) are reproduced with permission. [ 9b ] Copyright 2017, Elsevier Ltd.…”

“…In recent three decades, a lot of designer self‐assembling peptide hydrogels perform clinical trials in human beings. [ 59,60,62 ] As the biomimetic cell constructs are approved in medicinal products, the advantages and benefits of designer self‐assembling peptide hydrogels are clear for the translation to a clinical platform setting, which open the ways to high‐quality clinical trials to explore the usefulness of cell construct‐based therapy by biomedical nanotechnology. [ 49,66b ] So, the main efforts can be put into the researches involved in complex human diseases, such as prostate cancer, [ 114b ] breast cancer.…”

A novel self-assembling peptide for hemostasis during endoscopic submucosal dissection: a randomized controlled trial

“…The first clinical trial of Purastat was conducted in vascular surgery, where it was used on 33 vascular anastomotic sites in 25 patients [15]. It has also had favorable outcomes in nasal and cardiothoracic surgery [16,17]. Within endoscopy, its impact on delayed bleeding and wound healing following ESD has shown promise [18,19].…”