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

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, 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.