Risk factors for hypotension and technical complications during single-session double-filtration plasmapheresis: a 15-year retrospective study of 1,022 procedures.

Double-filtration plasmapheresis (DFPP) is increasingly used for immune-mediated and hematologic diseases, yet real-world safety data remain limited. In this 15-year retrospective study, we analyzed 1,022 DFPP sessions performed in 385 patients. The primary outcomes were hypotension and technical complications. Patient demographics, indications, laboratory parameters, treatment prescriptions, anticoagulation regimens, and procedure-related adverse events were collected. Mixed-effects logistic regression models were applied to identify factors associated with hypotension and technical complications. Hyperviscosity syndrome was the most common indication, accounting for 55.3% of all sessions. The mean treatment volume was 3.06 ± 0.41 L, corresponding to 0.95 ± 0.16 times the estimated plasma volume. Hypotension occurred in 15.3% of sessions and technical complications in 7.6%, both demonstrating significant declining trends over time (p < 0.05 for trend). Immune thrombotic thrombocytopenic purpura was independently associated with hypotension (OR 11.96, 95% CI 1.94-73.68). Older age modestly increased risk (OR 1.03 per year, 95% CI 1.00-1.06), while treatment year was inversely associated with hypotension (OR 0.77 per year, 95% CI 0.66-0.89). Technical complications were independently associated with use of the PLASAUTO Σ system (OR 8.78, 95% CI 2.76-27.97), use of non-heparin/non-nafamostat anticoagulants (OR 9.42, 95% CI 2.71-32.72), and hyperviscosity syndrome (OR 8.09, 95% CI 1.80-36.29). Among 309 sessions with paired measurements, median immunoglobulin reduction was 29.8% for IgG overall. DFPP demonstrated an acceptable safety profile, with declining complication rates over time. The risk of complications was influenced by underlying disease, patients' status, and anticoagulation strategy.