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Eur J Cardiothorac Surg 2006;29:880-885
© 2006 Elsevier Science NL

A new bioabsorbable sleeve for lung staple-line reinforcement (FOREseal^TM): report of a three-center phase II clinical trial

^a Department of Thoracic Surgery, University Hospital of Marseille, France
^b Department of Thoracic Surgery, University Hospital of Strasbourg, France
^c Department of Thoracic Surgery, University Hospital of Lille, France

Received 4 December 2005; received in revised form 24 January 2006; accepted 26 January 2006.

^_* Corresponding author. Address: Department of Thoracic Surgery, Ste Marguerite Hospital-CHU Sud, 270 Bd Ste Marguerite, 13274 Marseille Cedex 9, France. Tel.: +33 491 744 680; fax: +33 491 744 590. (Email: Pascal-alexandre.Thomas{at}mail.ap-hm.fr).

Objective: To investigate on the feasibility, safety, and effectiveness of a new bioabsorbable material for lung staple-line reinforcement. Methods: This prospective open trial included 66 patients (mean age of 56 ± 17 years) who underwent various types of lung resection using staplers with knitted calcium alginate sleeves for buttressing (FOREseal^TM, Laboratoires Brothier, Nanterre, France) at three academic centers: 29 lobectomies, 22 emphysema surgeries, 15 wedge resections or lung biopsies. Intraoperative air leakage was assessed at a mean respiratory peak pressure of 30 cmH₂O, and rated as grade 1, 2, or 3. Persistent air leakage in the postoperative course, as well as any relevant event, was assessed daily. The follow-up period was of 6 months. Results: No technical problem linked to the device occurred. Hemostasis of the cutting edges was completed in all patients. Fifty-six percent of the patients had no intraoperative air leak and 27.3% had grade 1 leaks. Mean postoperative air leaks and thoracic drainage times were 1.9 ± 2.3 days and 6 ± 5.3 days, respectively. In-hospital mortality was nil. There was no empyema. Mean hospital stay was 9.1 ± 6.6 days. At follow-up, one patient underwent lung transplantation, and pathology of the explanted specimen showed the absence of device-related foreign-body inflammation. One patient complained from metalloptysis, and another one, with a metastatic invasive aspergillosis, developed an infectious recurrence that required reoperation. Conclusions: FOREseal is an ergonomic, safe, and promising new material instead of nonabsorbable materials and xenomaterials for staple-line reinforcement. A randomized comparative study is now in progress.

Key Words: Lung surgery • New technology