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.

Highlights

  • Meticulous haemostasis remains a core principal in surgical practice, both for patient safety and for preserving the integrity of surgical repair [1]

  • The search for an ideal haemostatic adjunct to complement suturing of cardiac and aortic tissue and in fashioning anastomoses is ongoing, as the agent must possess a comprehensive catalogue of qualities such as ease of application, good adherence to site of use, cause minimal tissue reaction and prove robust in withstanding volume and pressure changes generated from the beating heart [3]

  • Patients whom exhibited preoperative derangements in haematological and coagulation profiles, and baseline derangements in liver function were excluded. Baseline demographic data such as age, gender, Body Mass Index (BMI), hypertension, diabetes, hypercholesterolaemia, previous myocardial infarction (MI), left ventricular (LV) function, smoking status, asthma or chronic obstructive pulmonary disease (COPD), renal impairment, neurological impairment and peripheral vascular disease was collected from pre-admission clerking sheets

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Summary

Introduction

Meticulous haemostasis remains a core principal in surgical practice, both for patient safety and for preserving the integrity of surgical repair [1]. The challenge of cardiac surgery involves operating on patients who are receiving single and dual antiplatelet or anticoagulant therapy, systemic heparinization and the effects of hypothermia on the clotting cascade [2]. The search for an ideal haemostatic adjunct to complement suturing of cardiac and aortic tissue and in fashioning anastomoses is ongoing, as the agent must possess a comprehensive catalogue of qualities such as ease of application, good adherence to site of use, cause minimal tissue reaction and prove robust in withstanding volume and pressure changes generated from the beating heart [3]. There are many established haemostatic agents on the market with varying mechanisms of action, which attests to the fact that there is no one ideal agent There are many established haemostatic agents on the market with varying mechanisms of action, which attests to the fact that there is no one ideal agent (Figs. 1 and 2).

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