A new application of air inflation adjustment technique in implant-based breast reconstruction: a nonrandomized clinical trial

Background: One of the leading factors contributing to suboptimal aesthetic outcomes in breast implant reconstruction is improper implant positioning and fixation. This issue is particularly pronounced in endoscopic procedures, where limited operative space and the patient's intraoperative positioning can complicate accurate placement. As a consequence, secondary or revision surgeries are often necessary to correct deformities caused by inadequate fixation and contraction of the pectoralis major muscle. To address this issue, our center developed an adjustment technique utilizing atmospheric pressure, referred to as the Air-Inflated Adjustment Technique (AIAT). By inflating the implant capsule with the patient in an upright position postoperatively, the implant naturally aligns with the contralateral breast under gravitational influence, thereby enhancing aesthetic outcomes. This prospective study aimed to evaluate the efficacy and safety of AIAT by comparing complications and aesthetic outcomes between patients who underwent AIAT and those who did not (N-AIAT). Methods: Patients who underwent reverse-sequence endoscopic nipple-sparing mastectomy (R-E-NSM) with immediate breast reconstruction (IBR) at the Breast Center, West China Hospital, Sichuan University, between September 2020 and June 2023, were divided into the N-AIAT and AIAT groups, enabling a comprehensive comparison of surgical complications and cosmetic outcomes. Findings: A total of 323 patients were prospectively enrolled in the study, with 168 (52.0%) in the N-AIAT group and 155 (48.0%) in the AIAT group. Compared to the N-AIAT group, patients in the AIAT group experienced shorter hospital stays, lower overall costs, increased breast ptosis, and a shorter median follow-up period (P < 0.05). After adjusting for clinical covariates. The AIAT group exhibited significantly higher Ueda scores at 1 month (1.122 [95% CI, 1.036-1.215]; P = 0.005) and at 12 months (1.374 [95% CI, 1.154-1.637]; P = 0.000) post-surgery, compared to the N-AIAT group. However, in both univariate and multivariate analyses, no significant differences were observed in the incidence of complications over three time periods: within 12 months postoperatively, within the first month, and between one and twelve months. This included any complications, major complications, specific treatment-related complications [Clavien-Dindo classification (CDC) ≥ 2], and surgical site infections (SSI). Subgroup multivariate analysis further indicated that AIAT is more suitable for patients undergoing prepectoral implant-based breast reconstruction, unilateral implant reconstruction, and those requiring chemotherapy and radiotherapy. Interpretation: AIAT is a safe, effective, and easily implementable non-surgical technique that can be applied to patients with varying breast sizes and degrees of ptosis. It significantly improves postoperative aesthetic results and effectively minimizes the necessity for secondary surgeries related to implant complications.