An observational study of CoSeal® for the prevention of adhesions in pediatric cardiac surgery☆☆☆

Abstract

We sought to evaluate the utility and safety of CoSeal Surgical Sealant (Baxter) for the prevention of cardiac adhesions in children. Seven cardiac surgery centers in Europe recruited consecutive pediatric patients requiring primary sternotomy for staged repair of congenital heart defects. Exclusion criteria included immune system disorder, unplanned reoperation, or reoperation within three months of primary repair. CoSeal was sprayed onto the surface of the heart at the end of surgery. Evaluation of adhesions took place at first reoperation. Data on safety, duration of surgery, and ease of CoSeal use were also collected. Seventy-nine pediatric patients were recruited between February 2005 and September 2007. Of these, 76 underwent major surgery to repair a wide range of congenital heart defects. Thirty-six patients underwent reoperation >3 months after primary repair, and were included in the efficacy analysis. Mean adhesions score was 8.3 (standard deviation [S.D.] 2.4; range 7-16). Six adverse events (5 serious) were possibly/definitely attributed to CoSeal. CoSeal's ease of use at primary operation was graded by surgeons as 12.1 mm (S.D. 9.8) on a visual analog scale of 0 ('very easy') to 100 mm ('very difficult'). Results of this prospective uncontrolled trial justify further investigation in a randomized, controlled trial.

Preliminary experience in the use of an extracellular matrix to repair congenital heart diseases

“…Lodge et al [9] described the use of a bioresorbable barrier film in order to prevent the formation of adhesions, and indeed many similar devices have been developed, with good results [10]. A second option is the use of an ECM for pericardial closure.…”

Reduction of Post-surgical Pericardial Adhesions Using a Pig Model

“…Total and differential white cell count, erythrocyte sedimentation rate and concentrations of C-reactive protein, prostaglandin E 2 and thromboxane B 2 were measured. In addition, the erythrocyte count, haemoglobin concentration, and measurements of coagulation including International Heart, Lung and Circulation Pericardial Adhesion Reduction (2012);21: [22][23][24][25][26][27][28][29] Normalisation Ratio, Activated Partial Thromboplastin Time and Prothrombin Time were determined. Eight animals in each group were slaughtered at an abattoir approximately at 12 weeks and the remaining three approximately 25 weeks after surgery.…”

“…Moreover, our results highlight the potential benefit of using a barrier/sealant for planned staged sternotomies. Napoleone's group published a prospective uncontrolled trial showing a favourable result in redo sternotomies when Coseal is applied to minimise adhesion formation [28,29]. His group found the same filmy and avascular type of adhesions when redo sternotomies were performed.…”

Binding of Anticell Adhesive Oxime‐Crosslinked PEG Hydrogels to Cardiac Tissues

“…[3, 9] In addition, the material must exhibit minimal swelling since high swelling could result in cardiac tamponade (pressure on the heart). This has been an issue with materials such as CoSeal®, [12] which swells 300-400% after application. [10, 13] …”