A Multicenter Prospective Study of Enhanced Viability Fat Transfer for Cosmetic Augmentation and Reconstruction of the Breast.

Summary

In a 14-center prospective cohort (N=190), fat processed by the FDA-cleared Viality system achieved stable, high volume retention (~85%) through 12 months, outperforming a 70% historical benchmark at all timepoints. Retention was influenced by transfer volume, patient weight change, and graft-to-recipient volume ratio, with consistent trends across cosmetic and reconstructive cohorts.

Key Findings

• Twelve-month mean volume retention was 84.8% (95% CI 83.2–86.5), significantly above the 70% benchmark at all timepoints (P<.0001).
• Retention was stable from month 1 to 12, indicating an early steady state without late decline.
• Retention determinants included transfer volume (P<.0001), patient weight change (P<.0001), and graft-to-recipient breast volume ratio (P=0.0187).
• Consistent high retention was observed in both cosmetic and reconstructive cohorts.

Clinical Implications

Greater predictability in long-term volume retention can reduce overcorrection, decrease the need for repeat sessions, improve counseling on expected outcomes, and standardize workflows in both cosmetic augmentation and reconstruction.

Limitations

• Nonrandomized design without a contemporaneous control arm using alternative processing methods.
• Follow-up limited to 12 months; long-term durability beyond one year remains to be established.

Future Directions

Randomized head-to-head trials comparing processing platforms, longer-term (≥24 months) outcomes, integration of patient-reported measures, and stratified analyses by oncologic treatment status (e.g., radiation).