BACKGROUND AND PURPOSE:

• Evidence of benefit for the use of intraoperative internal iliac balloon occlusion in the setting of placenta previa with suspected accreta is generally derived from retrospective studies
• Chen et al. (Obstetrics & Gynecology, 2020) prospectively assessed the effect of intraoperative internal iliac artery balloon occlusion in women with placenta previa and suspected placenta accreta

METHODS:

• Single-center, randomized controlled trial (RCT)
• Participants
  • Placenta previa and suspected placenta accreta
  • Diagnosis based on strict ultrasound criteria (all patients) and MRI at discretion of managing ObGyn
• Interventions
  • Balloon occlusion group
    • Catheter placed preoperatively, followed by intraoperative occlusion of bilateral internal iliac arteries
  • Control group: No balloon occlusion
• Statistical analysis
  • Perioperative management similar for both groups
  • 80% and two-sided α of 0.05: A sample size of 48 women per group was required to identify mean reduction of 2 units packed RBCs
• Primary outcome
  • Number of packed red blood cell (RBC) units transfused
• Secondary outcomes
  • Transfusion of other blood products | EBL | Cesarean hysterectomy | Other maternal and newborn outcomes and adverse events

RESULTS:

• 100 women participated were randomized
  • Balloon group: 50 women
  • Control group: 50 women
  • Demographic, obstetric, and placental imaging characteristics were similar between groups
  • Confirmation of accreta diagnosis
    • Surgical: 98% had surgical diagnosis
    • 70% had a histologic confirmation of accreta or percreta
• There was no significant difference in the number of packed RBC units transfused between the groups (p=0.54)
  • Balloon group: 5.3±5.3 units
  • Control group: 4.7±5.4 units
• There were no differences in secondary outcomes including
  • Other transfusion outcomes | Intraoperative EBL | Cesarean hysterectomy | Surgical injuries | Maternal ICU admission | Neonatal outcomes
• Post hoc analysis analyzing only women who underwent cesarean hysterectomy also demonstrated no difference in primary outcome or EBL
• The balloon group experienced significantly higher
  • Hospitalization costs: $7456 vs $4803 (P<.01)
  • Incidence of postoperative fever: 18% vs 2%; relative risk (RR) 10.8 (95% CI, 1.3 to 88.5, P=.02)

CONCLUSION:

• Authors recognize limitations
  • Single center
  • Study not blinded and could introduce bias as surgeons determine need for transfusion
• For women with placenta previa and suspected placenta accreta, intraoperative balloon occlusion of the internal iliac arteries did not result in a decrease in the number of packed RBC units transfused and may be associated with increased incidence of post-op fever

Learn More – Primary Sources:

Internal Iliac Artery Balloon Occlusion for Placenta Previa and Suspected Placenta Accreta – A Randomized Controlled Trial

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