Effective and rapid sealing of coronary, aortic and atrial suture lines †
Language English Country England, Great Britain Media print-electronic
Document type Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't
PubMed
25810290
DOI
10.1093/icvts/ivv061
PII: ivv061
Knihovny.cz E-resources
- Keywords
- Cardiac surgical procedures, Coronary artery bypass grafting, Sealing, Surgical sealant,
- MeSH
- Aortic Valve surgery MeSH
- Biocompatible Materials * MeSH
- Time Factors MeSH
- Heart Valve Prosthesis Implantation * adverse effects mortality MeSH
- Adult MeSH
- Surgical Wound Infection etiology MeSH
- Coronary Artery Bypass * adverse effects mortality MeSH
- Coronary Vasospasm etiology MeSH
- Blood Loss, Surgical prevention & control MeSH
- Middle Aged MeSH
- Humans MeSH
- Postoperative Hemorrhage prevention & control MeSH
- Prospective Studies MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Suture Techniques * adverse effects mortality MeSH
- Heart Arrest etiology MeSH
- Tissue Adhesives adverse effects therapeutic use MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Geographicals
- Czech Republic MeSH
- Germany MeSH
- Names of Substances
- Biocompatible Materials * MeSH
- Tissue Adhesives MeSH
OBJECTIVES: 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.
Department of Cardiac Surgery Hospital of the Brothers of Charity Trier Germany
Department of Cardiac Surgery University Hospital of Hradec Kralove Hradec Kralove Czech Republic
Department of Cardiac Surgery University Hospital of Pilsen Pilsen Czech Republic
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