Risk factors for hypotension and technical complications during single-session double-filtration plasmapheresis: a 15-year retrospective study of 1,022 procedures.
DFPP demonstrated an acceptable safety profile with declining complication rates over time, with hypotension occurring in 15.3% of sessions and technical complications in 7.6%, influenced by underlying disease, patient status, and anticoagulation strategy.
Key Findings
Results
Hypotension occurred in 15.3% of DFPP sessions and technical complications in 7.6% over the 15-year study period.
Study analyzed 1,022 DFPP sessions performed in 385 patients over 15 years.
Both hypotension and technical complications demonstrated significant declining trends over time (p < 0.05 for trend).
The study used mixed-effects logistic regression models to identify independent risk factors.
Data were collected retrospectively across patient demographics, indications, laboratory parameters, treatment prescriptions, anticoagulation regimens, and procedure-related adverse events.
Results
Immune thrombotic thrombocytopenic purpura (iTTP) was independently associated with a substantially elevated risk of hypotension during DFPP.
iTTP was associated with hypotension with an OR of 11.96 (95% CI 1.94–73.68).
This was identified as an independent risk factor via mixed-effects logistic regression.
Older age also modestly increased hypotension risk (OR 1.03 per year, 95% CI 1.00–1.06).
Treatment year was inversely associated with hypotension (OR 0.77 per year, 95% CI 0.66–0.89), reflecting improved outcomes over time.
Results
Use of the PLASAUTO Σ system was independently associated with a markedly higher risk of technical complications.
PLASAUTO Σ system use was associated with technical complications with an OR of 8.78 (95% CI 2.76–27.97).
Use of non-heparin/non-nafamostat anticoagulants was also independently associated with technical complications (OR 9.42, 95% CI 2.71–32.72).
Hyperviscosity syndrome as the treatment indication was independently associated with technical complications (OR 8.09, 95% CI 1.80–36.29).
All three factors were identified via mixed-effects logistic regression models.
Results
Hyperviscosity syndrome was the most common indication for DFPP, accounting for 55.3% of all sessions.
Hyperviscosity syndrome represented the majority of the 1,022 sessions analyzed.
The mean treatment volume was 3.06 ± 0.41 L, corresponding to 0.95 ± 0.16 times the estimated plasma volume.
Hyperviscosity syndrome was also independently associated with technical complications (OR 8.09, 95% CI 1.80–36.29).
Results
Among sessions with paired measurements, the median immunoglobulin reduction for IgG overall was 29.8%.
Paired measurements were available for 309 sessions.
The median IgG reduction was 29.8% overall across these sessions.
This provides a real-world estimate of DFPP efficacy for immunoglobulin removal.
The study population included immune-mediated and hematologic diseases, with varying immunoglobulin targets depending on indication.
Results
The anticoagulation regimen was identified as a significant determinant of technical complications, with non-heparin/non-nafamostat anticoagulants associated with substantially higher risk.
Non-heparin/non-nafamostat anticoagulant use was independently associated with technical complications (OR 9.42, 95% CI 2.71–32.72).
Heparin and nafamostat were used as the reference anticoagulation category.
The finding suggests that anticoagulation choice is a modifiable risk factor for procedure-related technical complications.
This was identified as one of three independent predictors of technical complications in multivariable analysis.
Results
Complication rates for both hypotension and technical complications showed significant declining trends over the 15-year study period, suggesting improvement in procedural practice.
Both hypotension (15.3% overall) and technical complications (7.6% overall) demonstrated statistically significant declining trends over time (p < 0.05 for trend).
Treatment year was inversely associated with hypotension risk (OR 0.77 per year, 95% CI 0.66–0.89) in multivariable analysis.
The authors attributed this to accumulated experience and improvements in technique over time.
The 15-year timeframe (spanning to approximately 2026 based on publication) allowed for detection of temporal trends.
What This Means
This research suggests that double-filtration plasmapheresis (DFPP) — a blood-filtering procedure used to treat immune and blood disorders by removing harmful proteins from the bloodstream — has an acceptable safety record, based on data from over 1,000 treatment sessions across 385 patients collected over 15 years. The most common reason for performing DFPP in this study was hyperviscosity syndrome (where blood becomes abnormally thick), accounting for more than half of all procedures. The procedure successfully reduced immunoglobulin (a type of protein targeted in these treatments) by about 30% on average per session.
The study identified specific factors that increased the likelihood of two main complications: low blood pressure (hypotension, occurring in about 1 in 7 sessions) and technical problems with the equipment (occurring in about 1 in 13 sessions). Patients with a specific clotting disorder called immune thrombotic thrombocytopenic purpura (iTTP) faced a nearly 12-fold higher risk of low blood pressure during the procedure. Older patients also had a slightly higher risk. Technical complications were strongly associated with the type of machine used, the type of anticoagulant (blood-thinning medication) administered, and having hyperviscosity syndrome as the underlying condition — each roughly multiplying the risk by 8 to 9 times compared to those without these factors.
Importantly, this research suggests that safety has improved substantially over the 15 years studied, with both types of complications declining significantly over time — likely reflecting better training, technique, and procedural protocols. These findings could help medical teams identify which patients need closer monitoring during DFPP and guide decisions about equipment selection and anticoagulation strategies to minimize procedural risks.
Gao C, Ma J, Jing M, Yang Z, Zhu Y, Yu H, et al.. (2026). Risk factors for hypotension and technical complications during single-session double-filtration plasmapheresis: a 15-year retrospective study of 1,022 procedures.. Renal failure. https://doi.org/10.1080/0886022X.2026.2667592