Abstract:

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.

Authors:

Frank Ulrich, MD, PhD, Head of Department, Dept. of General, Visceral, and Oncological Surgery, Wetzlar Hospital and Clinics, Wetzlar, Germany, Giuseppe Maria Ettorre, MD, Multiorgan Transplantation Program, General Surgery and Transplantation Unit, San Camillo Hospital, Rome, Italy, Luca Weltert, MD, European Hospital, Division of Cardiac Surgery, Rome, Italy, Martin Oberhoffer, MD, Cardiac Surgeon, Department of Cardiac Surgery, Asklepios Clinic St. Georg, Hamburg, Germany, Huub Kreuwel, PhD, Director, Global Medical Affairs, BioSurgery, Baxter Healthcare Corporation, Westlake Village, California, Rafaella De Santis, BS, Medical Scientific Liaison, Medical Affairs Department, BioSurgery, Baxter SpA, Rome, Italy, Erik Kuntze, MD, Medical Director, BioSurgery EMEA, Baxter Healthcare SA, Thurgauerstrasse, Zurich

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