title: Effective and rapid sealing of coronary, aortic and atrial suture lines †.
abstract: OBJECTIVE
  Cardiac surgical procedures carry a high risk of perioperative bleeding. Surgical sealants are often used to prevent suture line bleeding. PreveLeak™ is a surgical sealant composed of bovine serum albumin, a polyaldehyde cross-linker, and other components that forms a soft, flexible, water-tight, mechanical seal that is biocompatible and bioresorbable.
  
  
  METHODS
  A prospective, multicentre study evaluated PreveLeak use in 44 subjects undergoing 63 cardiac procedures, primarily coronary artery bypass grafting (n = 23/63, 36.5%) and aortic valve replacement (n = 19/63, 30.2%). PreveLeak was applied to 127 suture lines and the time to sealing evaluated upon clamp release. The primary safety endpoint was the incidence of significant bleeding, infections, neurological deficits and immune/inflammatory allergic responses within 6 weeks post-treatment; subjects were followed for 3 months.
  
  
  RESULTS
  Immediate sealing was achieved at all sites in 42 of 44 subjects (95.5%) and 125 of 127 treatment sites (98.4%). There were nine primary safety events: eight infections and one transient neurological deficit. Most adverse events were mild (n = 46/71, 64.8%) or moderate (n = 18/71, 25.4%) in severity. One adverse event (transient vasospasm) was considered possibly sealant-related. One death occurred due to a cardiac arrest.
  
  
  CONCLUSIONS
  PreveLeak prevented bleeding at 98.4% of treated sites and was well tolerated; adverse events were consistent with those commonly observed in subjects undergoing surgical procedures. These results compared favourably with published studies of other sealants. The observed prevention of bleeding is clinically important in cardiac surgical patients. A randomized, comparative study is justified to further evaluate PreveLeak and confirm the findings from this study.
authors: Department of Cardiac Surgery, University Hospital of Pilsen, Pilsen, Czech Republic skorpilj@fnplzen.cz.
authors: Jiri
authors: J
authors: Skorpil
authors: Department of Cardiac Surgery, Hospital of the Brothers of Charity, Trier, Germany.
authors: Alexandros
authors: A
authors: Paraforos
authors: Department of Cardiac Surgery, University Hospital of Hradec Kralove, Hradec Kralove, Czech Republic.
authors: Jiri
authors: J
authors: Mandak
authors: Department of Cardiopulmonary Transplantation and the Center for Cardiac Support, Texas Heart Institute, Houston, TX, USA.
authors: William E
authors: WE
authors: Cohn
authors: Department of Cardiac Surgery, University Hospital of Pilsen, Pilsen, Czech Republic.
authors: Tomas
authors: T
authors: Hajek
authors: Department of Cardiac Surgery, Hospital of the Brothers of Charity, Trier, Germany.
authors: Ivan
authors: I
authors: Friedrich
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001672:Biocompatible Materials; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D001026:Coronary Artery Bypass / Q000009:adverse effects / Q000401:mortality; D003329:Coronary Vasospasm / Q000209:etiology; D018153:Czech Republic; D005260:Female; D005858:Germany; D006323:Heart Arrest / Q000209:etiology; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000401:mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000517:prevention & control*; D011446:Prospective Studies; D013530:Surgical Wound Infection / Q000209:etiology; D013536:Suture Techniques / Q000009:adverse effects / Q000401:mortality; D013997:Time Factors; D014014:Tissue Adhesives / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D001672:Biocompatible Materials; D014014:Tissue Adhesives
keywords: Cardiac surgical procedures; Coronary artery bypass grafting; Sealing; Surgical sealant