Intra-operative Use of Hemopatch®: Interim Results of a Nationwide European Survey of Surgeons.

INTRODUCTION: Haemostasis is a critical part of surgery. Haemostatic agent selection is based upon a number of factors including surgeon's experience and choice. This post-marketing survey determined surgeons' intraoperative use and perception of Hemopatch® (Baxter Healthcare Corporation, Deerfield, IL), a resorbable collagen-based sealing haemostat.

METHODS AND PARTICIPANTS: A one-arm questionnaire was distributed to European general, cardiac, pulmonary, and urologic surgeons who used Hemopatch® to achieve haemostasis in situations where bleeding control by pressure, ligature, or conventional procedures had been ineffective or was impractical. Responses were summarized for patient characteristics, surgical procedures/techniques, and surgeons' assessment of Hemopatch® regarding their overall satisfaction and utilization characteristics of Hemopatch®.

RESULTS: Of 1028 responses received from seven European countries, the majority were from Germany (47.3%) or Italy (36%). Most cases were in males (60.7%), 50-75 years of age (61.8%), performed by an open approach (82.5%), with 52.7% general-, 16.2% cardiac-, 7.5% lung, 19.5% urologic-type procedures and 3.7% other/unknown. Successful haemostasis after two minutes of approximation occurred in 93.3% of patients (86.8%-96.9% across surgical subtypes), with similar rates by approach (93.1% open; 94.1% minimally-invasive), and patient's use of anticoagulant and/or antiplatelet agents (87.9% - 93.1%). Over 92% of surgeon's rated Hemopatch® as "excellent" or "good" in assessments of overall satisfaction, haemostasis efficacy, ease of preparation, ease of handling, flexibility/pliability, and tissue adherence. These characteristics were rated as excellent or good by 81% or more of surgeons in analyses by surgical subspecialty and surgical approach of open or minimally invasive.

CONCLUSIONS: Hemopatch® provides effective haemostasis across a variety of surgical procedures, both in open- and minimally-invasive, as well as in patients receiving anticoagulant and/or antiplatelet agents. Surgeon's generally rated their overall satisfaction with Hemopatch®, its haemostatic efficacy, and other characteristics as "much better" or "better" than their previously used haemostat.