Neoveil versus TachoSil in the treatment of pulmonary air leak following open lung surgery: a prospective randomized trial

Helga Bachmann, Sandrine V C Dackam, Aljaz Hojski, Jelena Jankovic, Deborah R Vogt, Mark N Wiese, Didier Lardinois, Helga Bachmann, Sandrine V C Dackam, Aljaz Hojski, Jelena Jankovic, Deborah R Vogt, Mark N Wiese, Didier Lardinois

Abstract

Objectives: Prolonged air leak (PAL) is often associated with pain and immobilization and is a major limiting factor for discharge from the hospital. The efficacy of 2 surgical patches was investigated in the treatment of air leak following open surgery.

Methods: Forty-five patients were randomized in a 1:1 ratio either to treatment with Neoveil (polyglycolic acid) (n = 22) or TachoSil (collagen sponge) (n = 23). Air leak was monitored at 2, 4, 8, 12 and 24 h after surgery and then daily at 8 am and 6 pm, using a digital recording system. The primary outcome was the time to air leak closure. Secondary outcomes were incidence, air leak intensity, incidence of PAL and incidence of pneumonia.

Results: Air leak 2 h after surgery was observed in 11/22 (50%) vs 14/23 (61%) patients treated with polyglycolic acid, respectively, with collagen sponge. On average, air loss within the first 24 h after surgery was lower and declined faster in patients treated with polyglycolic acid. Time to pulmonary air leak closure was somewhat shorter with polyglycolic acid (median [interquartile range] 10 [2, 52] h) compared to collagen sponge (19 [2, 141] h). However, the difference was not statistically significant (P = 0.35, Wilcoxon rank-sum test). PAL occurred in 3/22 (14%) vs 6/23 (26%) patients, and pneumonia occurred in 2/22 (9%) vs 3/23 (13%) patients treated with polyglycolic acid, respectively, collagen sponge.

Conclusions: Both systems are effective in the treatment of air leak. Our results suggest a possible superiority of Neoveil over TachoSil in post-surgery air leak control.

Clinical trial registration number: NCT04065880.

Keywords: Neoveil; Open lung surgery; Pulmonary air leak; TachoSil.

© The Author(s) 2023. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.

Figures

Figure 1:
Figure 1:
Time to closure of pulmonary air leak in hours from the end of surgery, with dots representing the measures of individual patients.
Figure 2:
Figure 2:
Air leaks (l) within the first 24 h after surgery. Upper panel: individual courses; each line represents 1 patient. Lower panel: summarized data at each measurement time.
Figure 3:
Figure 3:
Area under the curve (AUC) of air leaks (l) over the first 24 h after surgery. Dots represent the measures of individual patients.
Figure 4:
Figure 4:
Time to air leak closure. Cumulative event curves with 95% confidence bands. The Y-axis shows the proportion of patients with air leak closure, i.e. air leak ˂30 ml. The vertical dashed lines indicate the time at which half of the patients reached air leak closure for each treatment group (median time to air leak closure). The numbers in the table below indicate the number of patients with a persistent air leak in each treatment group for the respective time point.
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/9846424/bin/ezad003f5.jpg

References

    1. Moser C, Opitz I, Zhai W, Rousson V, Russi EW, Weder W. et al. Autologous fibrin sealant reduces the incidence of prolonged air leak and duration of chest tube drainage after lung volume reduction surgery: a prospective randomized blinded study. J Thorac Cardiovasc Surg 2008;136:843–9.
    1. Okereke I, Murthy SC, Alster JM, Blackstone EH, Rice TW.. Characterization and importance of air leak after lobectomy. Ann Thorac Surg 2005;79:1167–73.
    1. McGuire AL, Yee J.. Clinical outcomes of polymeric sealant use in pulmonary resection: a systematic review and meta-analysis of randomized controlled trials. J Thorac Dis 2018;10:S3728–S3739.
    1. Belda-Sanchís J, Serra-Mitjans M, Iglesias Sentis M, Rami R.. Surgical sealant for preventing air leaks after pulmonary resections in patients with lung cancer. Cochrane Database Syst Rev 2010;2010:Cd003051.
    1. Attaar A, Winger DG, Luketich JD, Schuchert MJ, Sarkaria IS, Christie NA. et al. A clinical prediction model for prolonged air leak after pulmonary resection. J Thorac Cardiovasc Surg 2017;153:690–9.e2.
    1. De Leyn P, Muller MR, Oosterhuis JW, Schmid T, Choong CK, Weder W. et al. Prospective European multicenter randomized trial of PleuraSeal for control of air leaks after elective pulmonary resection. J Thorac Cardiovasc Surg 2011;141:881–7.
    1. Brunelli A, Bölükbas S, Falcoz PE, Hansen H, Jimenez MF, Lardinois D. et al. Exploring consensus for the optimal sealant use to prevent air leak following lung surgery: a modified Delphi survey from The European Society of Thoracic Surgeons. Eur J Cardiothorac Surg 2021;59:1265–71.
    1. Malapert G, Hanna HA, Pages PB, Bernard A.. Surgical sealant for the prevention of prolonged air leak after lung resection: meta-analysis. Ann Thorac Surg 2010;90:1779–85.
    1. Orsini B, Baste JM, Gossot D, Berthet JP, Assouad J, Dahan M. et al. Index of prolonged air leak score validation in case of video-assisted thoracoscopic surgery anatomical lung resection: results of a nationwide study based on the French national thoracic database, EPITHOR. Eur J Cardiothorac Surg 2015;48:608–11.
    1. Rocco G, Rendina EA, Venuta F, Mueller MR, Halezeroglu S, Dienemann H. et al. The use of sealants in modern thoracic surgery: a survey. Interact CardioVasc Thorac Surg 2009;9:1–3.
    1. Lin XM, Liu Y, Chi C, Lin CX, Yang Y.. Efficacy of an absorbable polyglycolic acid patch in surgery for pneumothorax due to silicosis. J Cardiothorac Surg 2012;7:18.
    1. Filosso PL, Ruffini E, Sandri A, Lausi PO, Giobbe R, Oliaro A.. Efficacy and safety of human fibrinogen-thrombin patch (TachoSil®) in the treatment of postoperative air leakage in patients submitted to redo surgery for lung malignancies: a randomized trial. Interact CardioVasc Thorac Surg 2013;16:661–6.
    1. Filosso PL, Guerrera F, Sandri A, Zenga F, Lanza GV, Ruffini E. et al. Efficacy and safety of human fibrinogen-thrombin patch (Tachosil(®)) in the management of diffuse bleeding after chest wall and spinal surgical resection for aggressive thoracic neoplasms. J Thorac Dis 2016;8:E152–6.
    1. Brunelli A, Chapman K, Pompili C, Chaudhuri N, Kefaloyannis E, Milton R. et al. Ninety-day hospital costs associated with prolonged air leak following lung resection. Interact CardioVasc Thorac Surg 2020;31:507–12.
    1. Gilbert S, Maghera S, Seely AJ, Maziak DE, Shamji FM, Sundaresan SR. et al. Identifying patients at higher risk of prolonged air leak after lung resection. Ann Thorac Surg 2016;102:1674–9.
    1. Seder CW, Basu S, Ramsay T, Rocco G, Blackmon S, Liptay MJ. et al. A Prolonged air leak score for lung cancer resection: an analysis of the Society of Thoracic Surgeons General Thoracic Surgery Database. Ann Thorac Surg 2019;108:1478–83.
    1. Pompili C, Falcoz PE, Salati M, Szanto Z, Brunelli A.. A risk score to predict the incidence of prolonged air leak after video-assisted thoracoscopic lobectomy: an analysis from the European Society of Thoracic Surgeons database. J Thorac Cardiovasc Surg 2017;153:957–65.
    1. Rena O, Papalia E, Mineo TC, Massera F, Pirondini E, Turello D. et al. Air-leak management after upper lobectomy in patients with fused fissure and chronic obstructive pulmonary disease: a pilot trial comparing sealant and standard treatment. Interact CardioVasc Thorac Surg 2009;9:973–7.
    1. Hüttner FJ, Mihaljevic AL, Hackert T, Ulrich A, Büchler MW, Diener MK.. Effectiveness of Tachosil(®) in the prevention of postoperative pancreatic fistula after distal pancreatectomy: a systematic review and meta-analysis. Langenbecks Arch Surg 2016;40:151–9.
    1. Marta GM, Facciolo F, Ladegaard L, Dienemann H, Csekeo A, Rea F. et al. Efficacy and safety of TachoSil® versus standard treatment of air leakage after pulmonary lobectomy. Eur J Cardiothorac Surg 2010;38:683–9.
    1. Gonfiotti A, Santini PF, Jaus M, Janni A, Lococo A, De Massimi AR. et al. Safety and effectiveness of a new fibrin pleural air leak sealant: a multicenter, controlled, prospective, parallel-group, randomized clinical trial. Ann Thorac Surg 2011;92:1217–24; discussion 24–5.
    1. Allen MS, Wood DE, Hawkinson RW, Harpole DH, McKenna RJ, Walsh GL. et al.; 3M Surgical Sealant Study Group. Prospective randomized study evaluating a biodegradable polymeric sealant for sealing intraoperative air leaks that occur during pulmonary resection. Ann Thorac Surg 2004;77:1792–801.
    1. Kawai N, Kawaguchi T, Suzuki S, Yasukawa M, Tojo T, Taniguchi S.. Low-voltage coagulation, polyglycolic acid sheets, and fibrin glue to control air leaks in lung surgery. Gen Thorac Cardiovasc Surg 2017;65:705–9.

Source: PubMed

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

3
Abonnieren