CLINICAL AND IMMUNOLOGICAL PREDICTORS OF AESTHETIC COMPLICATIONS IN LIPOFILLING AND VALIDATION OF THE IPROL IMMUNOLOGICAL RISK STRATIFICATION SCALE: A PROSPECTIVE COMPARATIVE COHORT STUDY

Resume. Background: Aesthetic complications following lipofilling - including fat graft non-integration, lipogranuloma formation, fat necrosis, and fibrosis - affect 15–30% of patients. While technical and anatomical factors have traditionally been emphasized, the immunological basis of these complications remains incompletely characterized. Preoperative stratification based on immune parameters has not previously been validated in a clinical cohort study. Objectives: To characterize the preoperative immunological profile associated with complicated lipofilling outcomes, to perform immunohistochemical characterization of morphological complication types, to develop and validate the IPROL (Immunological Prognosis of Lipofillate Rejection) risk stratification scale, and to evaluate the clinical efficacy of an IPROL-guided prevention algorithm in a prospective comparative design. Methods: 208 participants were enrolled at Bukhara Regional Multidisciplinary Medical Center (2019–2024): 188 patients undergoing lipofilling (Control group, n=93; Main group, n=95) and 20 healthy volunteers as a reference group. The primary anatomical zones were breast (37.8%), face (26.6%), buttocks (22.9%), and other sites (12.8%). Preoperative immune assessment included flow cytometry for lymphocyte subsets (CD3⁺, CD4⁺, CD8⁺, NK cells, CD19⁺), ELISA-based serum cytokine profiling (IL-6, TNF-α, TGF-β1, IL-10), and CRP measurement. The IPROL scale, integrating IL-6, CD4⁺/CD8⁺ ratio, and NK cell count, was developed and applied in the Main group to guide a three-level prevention algorithm. Complicated outcomes (graft volume loss >30%, infiltrates, cysts, asymmetry, fat necrosis) were verified by ultrasound and, in 34 cases, biopsy with immunohistochemical (IHC) staining for CD68⁺, IL-6⁺, and TGF-β1. Statistical analysis: Mann-Whitney U test, Pearson chi-square, Pearson correlation, multivariate logistic regression, ROC analysis (IBM SPSS 26.0; significance p < 0.05). Results: The overall complication rate in the Control group was 36.6%, with the highest rates in breast (45.9%) and buttock (42.9%) lipofilling zones. Patients with complicated outcomes exhibited significantly higher preoperative IL-6 (4.9 ± 1.1 vs. 2.4 ± 0.7 pg/mL; p < 0.001), TNF-α, TGF-β1, CRP, and elevated CD4⁺/CD8⁺ ratio (2.27 ± 0.41 vs. 1.94 ± 0.28; p < 0.01), with significantly lower NK cell levels (8.2 ± 2.4% vs. 11.5 ± 2.9%; p < 0.01). Multivariate analysis identified IL-6 > 7 pg/mL (OR = 6.6; p = 0.001), CD4⁺/CD8⁺ > 2.0 (OR = 5.5; p = 0.003), and NK cells < 8% (OR = 3.2; p = 0.019) as independent predictors of complicated outcomes. Breast zone was the highest-risk anatomical site (OR = 5.06). IHC revealed five morphological complication types; lipogranuloma (32.4%) and fat necrosis (11.8%) were characterized by the highest CD68⁺ and IL-6⁺ expression. Application of the IPROL-guided prevention algorithm in the Main group reduced overall complication rates from 36.6% to 15.8% (p = 0.001), high-risk subgroup complications from 70.6% to 31.0%, and mean affected graft volume from 28.4 cm³ (36.7%) to 12.1 cm³ (13.4%). Conclusions: Aesthetic complications of lipofilling are immunologically determined, driven by a preoperative inflammatory phenotype characterized by elevated IL-6, cytokine imbalance, and NK cell depletion. The IPROL scale provides a validated, accessible, and clinically actionable preoperative risk stratification tool. Immunologically tailored prevention significantly reduces both the frequency and severity of complications, including in high-risk patients and anatomically vulnerable zones. Keywords: lipofilling; fat grafting; lipotransfer; immunological risk; CD4/CD8 ratio; natural killer cells; interleukin-6; lipogranuloma; fat necrosis; risk stratification; IPROL scale; aesthetic surgery

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