Comparison of Cell Salvage with One and Two Suction Devices During Cesarean Section in Patients with Placenta Previa and/or Accrete: A Randomized Controlled Trial

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Comparison of Cell Salvage with One and Two Suction Devices During Cesarean Section in Patients with Placenta Previa and/or Accrete: A Randomized Controlled Trial

Placenta previa and placenta accreta spectrum disorders are high-risk obstetric conditions associated with life-threatening hemorrhage during cesarean section (CS). Intra-operative cell salvage (IOCS) has emerged as a critical strategy to reduce reliance on allogeneic blood transfusions and mitigate associated risks. However, concerns about contamination from amniotic fluid (AF) components, such as squamous cells, lamellar bodies, and fetal red blood cells (RBCs), have historically limited its adoption in obstetrics. This randomized controlled trial evaluated the efficacy and safety of IOCS using one versus two suction devices during CS in patients with placenta previa and/or accreta, focusing on salvaged RBC volume and residual AF contaminants.

Study Design and Methodology

Thirty patients diagnosed with placenta previa and/or accreta, scheduled for elective CS at 35–38 weeks of gestation, were enrolled. Exclusion criteria included infections, diabetes, pre-eclampsia, and maternal comorbidities. Participants were randomized into two groups using an Excel-generated random number sheet:

  • Group 1 (n = 15): A single suction device aspirated all blood and AF throughout the procedure.
  • Group 2 (n = 15): A second suction device was primarily used to aspirate AF before placental delivery, while the first device collected blood post-placental delivery.

Cell salvage was performed using the Continuous Autotransfusion System (Fresenius Kabi AG), with collected blood washed via a quality wash program and filtered using a leucodepletion filter (LeukoGuard RS). Three blood samples per patient—pre-wash (from the reservoir), post-wash (after processing), and post-filtration (after leucodepletion)—were analyzed for AF contaminants. Key metrics included:

  1. Salvaged RBC volume (primary outcome).
  2. AF components: Squamous cells, lamellar bodies, fat, insulin-like growth factor binding protein 1 (IGFBP1), alpha-fetoprotein (AFP), albumin, lactate dehydrogenase (LDH), potassium, and fetal RBCs.

Key Findings

Salvaged RBC Volume

Group 1 demonstrated a significantly higher salvaged RBC volume compared to Group 2 (401.6 ± 77.2 mL vs. 330.1 ± 53.3 mL; t = 4.175, P < 0.001). The total collected blood volume was also greater in Group 1 (1765.6 ± 347.2 mL vs. 1123.3 ± 185.9 mL; t = 8.933, P < 0.001), highlighting reduced blood waste with a single suction device.

Amniotic Fluid Contaminant Removal

Squamous Cells

  • Pre-wash: Median counts were similar between groups (Group 1: 5 [Q1–Q3: 2–8] vs. Group 2: 5 [1–6] per high-power field [HPF]).
  • Post-wash: Counts reduced significantly in both groups (Group 1: 2 [1–5]; Group 2: 2 [1–3]; P < 0.001).
  • Post-filtration: Squamous cells were undetectable in 24/30 samples, with residual cells in three samples per group (0 [0–0] HPF; P < 0.001 vs. post-wash).

Lamellar Bodies and Fat

  • Lamellar bodies: Pre-wash counts (12 [10–15] HPF) decreased post-wash (Group 1: 4 [3–6]; Group 2: 5 [3–5]; P < 0.001) and were fully eliminated post-filtration.
  • Fat: Pre-wash counts (10 [10–10] HPF) dropped post-wash (Group 1: 0 [0–1]; Group 2: 2 [0–2]; P < 0.001) and were absent post-filtration.

Biochemical Markers

  • IGFBP1: Reduced from 113.0 ± 17.1 ng/mL (pre-wash) to 15.6 ± 4.2 ng/mL (post-wash) in Group 1 and from 115.1 ± 17.3 ng/mL to 22.5 ± 9.9 ng/mL in Group 2 (P < 0.001). Post-filtration levels showed no further reduction (Group 1: 12.2 ± 5.5 ng/mL; Group 2: 13.1 ± 6.0 ng/mL; P > 0.05).
  • AFP: Declined from 1202.1 ± 107.6 ng/mL (pre-wash) to 204.5 ± 63.9 ng/mL (post-filtration) in Group 1 and from 1342.8 ± 146.1 ng/mL to 146.4 ± 35.5 ng/mL in Group 2 (P < 0.001).
  • Albumin, LDH, and Potassium: All showed significant reductions post-wash (P < 0.01), with no further changes post-filtration.

Fetal RBC Contamination
Fetal RBCs persisted in all post-filtration samples but at low levels:

  • Group 1: 1.8 ± 0.8% (range: 1.0–3.5%).
  • Group 2: 1.9 ± 0.9% (range: 0.7–4.0%).
    No intergroup difference was observed (U = 188.5, P = 0.651).

Clinical Implications

  1. Enhanced RBC Salvage: Using a single suction device increased salvaged RBC volume by 21.6% compared to two devices, optimizing autologous transfusion in high-bleeding-risk scenarios.
  2. Effective AF Contaminant Removal: Washing and leucodepletion eliminated lamellar bodies and fat entirely, while squamous cells and biochemical markers (IGFBP1, AFP) were reduced to clinically insignificant levels.
  3. Safety Profile: Residual fetal RBCs (≤4.0%) pose minimal alloimmunization risk, particularly with routine Anti-D prophylaxis. No adverse events (e.g., hypotension, embolism) were reported during reinfusion.

Methodological Considerations

  • Sample Size: Powered at 90% to detect a 60 mL difference in RBC volume, the study’s robust design supports its conclusions.
  • Limitations: Small cohort size and single-center design may limit generalizability. Long-term maternal alloimmunization risks require further investigation.

Conclusion

This trial demonstrates that IOCS with a single suction device during CS for placenta previa and/or accreta significantly improves RBC recovery without compromising safety. The combination of washing and leucodepletion effectively removes AF contaminants, addressing historical concerns. These findings advocate for broader adoption of single-device IOCS in obstetric settings anticipating massive hemorrhage, aligning with current guidelines promoting patient blood management.

doi.org/10.1097/CM9.0000000000000699

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