A prospective, randomized controlled study to evaluate efficacy of argon beam coagulation versus conventional electrosurgical coagulation for cutting and coagulation during mastectomy with reconstruction.

Abstract

e12586 Background: In patients undergoing mastectomy, the large raw surface from the dissection requires meticulous hemostasis to minimize surgical complications. Conventional electrosurgical coagulation (CEC) systems are a popular choice for dissection of the mastectomy flaps and for securing hemostasis. Argon beam coagulation (ABC) may allow for more rapid hemostasis which may impact blood loss, drain duration and drain output. The objective of this study is to evaluate device efficacy between the ABC and CEC for cutting and coagulation during mastectomy procedures with reconstruction. Methods: This single-institution, randomized trial consisted of consenting women undergoing unilateral or bilateral mastectomy and reconstruction. All enrolled subjects underwent mastectomy with immediate breast reconstruction and were randomized in a 1:1 fashion to either ABC or CEC. Each patient was followed for 2 months post-surgical drain removal and exited from the study. The study was powered to demonstrate the superiority of the ABC to CEC for post-mastectomy procedure time to hemostasis. Secondary outcomes measured included: blood loss, drainage duration, and total drain output. Statistical comparisons for time to hemostasis was made with mixed-effects analysis of variance. Blood loss, drainage duration and total drain output were compared using analysis of covariance, adjusted for bilateral or unilateral treatment. Results: A total of 82 patients were randomized (41 to ABC and 41 to CEC) between April 2021 and September 2024. Patients ranged in age from 26 to 80 years. Mastectomy with reconstruction was performed for a diagnosis of breast cancer in 68 patients (83%) and for risk-reduction in 14 patients (17%). There were 18 unilateral procedures (22%) and 64 bilateral procedures (78%). The patients underwent reconstruction as follows: tissue expander placement in 47 patients (57%), direct-to-implant in 7 patients (9%), deep inferior epigastric perforator flap in 27 patients (33%) and profunda artery perforator flap in 1 patient (1%). The primary and secondary endpoints are listed in Table 1. Post-mastectomy procedure time to hemostasis, was significantly different between ABC and CEC. Conclusions: In patients undergoing mastectomy with reconstruction, ABC shows improved time to hemostasis compared to CEC. There was no difference in secondary outcomes of blood loss, drainage duration and total drain output. Primary and secondary endpoints of ABC versus CEC. Endpoint Argon beam coagulation Conventional electrosurgical coagulation p -value Time to hemostasis (mins) 3.9 ± 3.9 6.9 ± 4.8 p < 0.001 Blood loss (mL) 126.0±81.0 173.1±260.8 p = 0.3 Drainage duration (days) 14.3±4.9 14.2±5.0 p = 0.9 Total drain ouput (mL) 1175±610 1168±770 p = 0.9