Niharika Rajan Garach, Jay Rashmi Anam, Imaan Rumani, Esha Trivedi, Nilesh Chordiya, Emily Klosterman, Ameer Gomberawalla, Reshma Suvarna, Eli Avisar
S-LYMPHA was technically feasible and safe in this initial South Asian feasibility cohort. These early data should be interpreted as evidence of implementability and short-term safety rather than proof of lymphedema prevention. Larger comparative cohorts with longer follow-up are required to define efficacy, durability, and oncologic safety.
OBJECTIVE: Breast cancer-related lymphedema is an important survivorship concern after axillary lymph node dissection. Conventional LYMPHA and immediate lymphatic reconstruction can reduce this risk, but adoption in low- and middle-income settings is limited by the need for microsurgical personnel, equipment, additional operating time, and cost. This study reports an initial feasibility assessment of simplified LYMPHA (S-LYMPHA) performed by breast surgical oncologists using indocyanine green guidance.
MATERIALS AND METHODS: This was a prospective, single-arm feasibility cohort study. Consecutive eligible patients undergoing planned axillary lymph node dissection or completion axillary dissection after a positive intraoperative sentinel node assessment were enrolled from July 2024 to September 2025. Arm circumferences were measured preoperatively and at 3 and 6 months, at three fixed points. After confirmation that axillary dissection was required, methylene blue and indocyanine green were injected into the ipsilateral upper limb. Arm lymphatics were identified, preserved, and invaginated into a suitable axillary venous tributary after nodal dissection. The primary outcomes of this interim report were technical feasibility, short-term safety, and clinical lymphedema at 6 months.
RESULTS: Thirty-seven patients underwent attempted S-LYMPHA. The median age was 51 years. Nineteen patients (51.4%) received neoadjuvant chemotherapy and 26 patients (70.3%) underwent mastectomy. Sixteen patients (43.2%) required axillary dissection after nodal metastasis was detected on intraoperative sentinel node assessment. Arm lymphatics were identified in all patients. The mean number of lymphatics identified was 2.6 (range 1-5), and the mean number of lymphovenous anastomoses created was 1.5 (range 1-3). More than one anastomosis was performed in 16 (43.2%) patients. At a uniform 6-month follow-up, one patient had clinical lymphedema, corresponding to an observed incidence of 2.7% (exact 95% confidence interval, 0.07-14.16). No dye-related adverse reaction or local complication attributable to the lymphatic reconstruction was observed.
CONCLUSION: S-LYMPHA was technically feasible and safe in this initial South Asian feasibility cohort. These early data should be interpreted as evidence of implementability and short-term safety rather than proof of lymphedema prevention. Larger comparative cohorts with longer follow-up are required to define efficacy, durability, and oncologic safety.