Sustained Air Sealing Efficacy of a Sealing Patch in Pulmonary Lobectomy

Abstract

Purpose: Postoperative air leakage remains the most common pulmonary complication after resection of the lung. The objective of this study was to evaluate the postoperative efficacy of a new surgical patch for the sealing of alveolar air leakage in patients undergoing elective pulmonary lobectomy. Methods: Patients scheduled for standard lobectomy were included in this prospective, open-label, randomized controlled study, conducted at 12 European university hospitals. Following thoracotomy, lobectomy, and primary stapling, patients with intraoperative air leak grade 1-2 (water submersion test; Macchiarini et al, 1999) were randomized to a sealing patch (SP) or additional standard surgical treatment, i.e., suturing and further stapling (STD). Assessment of postoperative air leakage was performed twice daily until chest drain removal. Results: A total of 301 patients were included and randomized, of whom 299 received trial treatment (SP: 149; STD: 150). Mean age was 64 years (33-83 years), 67% were males and 33% females. Preoperatively, the treatment groups were well-balanced regarding mean BMI (25.8 vs 26.1 kg/m2), mean FEV-1 (2.48 vs 2.50 L), mean TLC (6.17 vs. 6.14 L) and mean RV (2.65 vs 2.61 L) for SP and STD, respectively. At the end of surgery, 68.2% of SP and 42.4% of STD patients were air leak free (OR 5.27 [95% CI: 1.26-21.96]; p=0.022; ITT). The duration of postoperative air leakage was significantly shorter in SP compared with STD patients (p=0.030; log-rank test). The proportions of patients remaining air leak free at discharge from surgical ward were 29.7% and 19.2% for SP and STD patients, respectively (OR 4.93 [95% CI: 1.33- 18.31]; p=0.017; ITT). The occurrence of adverse events was similar for both treatments. Conclusions: The study demonstrated superior efficacy of a sealing patch compared with standard surgical treatment for sustained sealing of postoperative air leakage following pulmonary lobectomy