Perioperative prophylactic internal iliac artery balloon occlusion in the prevention of postpartum hemorrhage in placenta previa: a randomized controlled trial.

Placenta previa remains one of the major causes of massive postpartum hemorrhage and maternal mortality worldwide. To determine whether internal iliac artery balloon occlusion during cesarean delivery for placenta previa could reduce postpartum hemorrhage and other maternal complications. This was a prospective randomized controlled trial conducted at a tertiary university obstetric unit in Hong Kong. Pregnant women who were diagnosed to have placenta previa at 34 weeks (defined as lower placenta edge within 2 cm from the internal os) and required cesarean delivery were invited to participate. Eligible pregnant women were randomized into internal iliac artery balloon occlusion (Occlusion) group or standard management (Control) group. Those randomized to the Occlusion group had internal iliac artery balloon catheter placement performed before cesarean delivery and then balloon inflation after delivery of the baby. The primary outcome was the reduction of postpartum hemorrhage in those with internal iliac artery balloon occlusion. Secondary outcome measures included hemoglobin drop after delivery; amount of blood product transfusion; incidence of hysterectomy; maternal complications including renal failure, ischemic liver, disseminated intravascular coagulation, and adult respiratory distress syndrome; length of stay in hospital; admission to intensive care unit; and maternal death. Between May 2016 and September 2018, 40 women were randomized (20 in each group). Demographic and obstetric characteristics were similar between the 2 groups. In the Occlusion group, 3 women did not receive the scheduled procedure, as it was preceded by antepartum hemorrhage that required emergency cesarean delivery, and 1 woman had repeated scan at 36 weeks showing the placental edge was slightly more than 2 cm from the internal os. Intention-to-treat analysis found no significant differences between the Occlusion and the Control groups regarding to the median intraoperative blood loss (1451 [1024-2388] mL vs 1454 [888-2300] mL; P = .945), the median length of surgery (49 [30-62] min vs 37 [30-51] min; P = .204), or the need for blood transfusion during operation (57.9% vs 50.0%; P = .621). None of the patients had rebleeding after operation, complication related to internal iliac artery procedure, or any other maternal complications. Reanalyzing the data using on-treatment approach showed the same results. The use of prophylactic internal iliac artery balloon occlusion in placenta previa patients undergoing cesarean delivery did not reduce postpartum hemorrhage or have any effect on maternal or neonatal morbidity.

Yu SCH ，Cheng YKY ，Tse WT ，Sahota DS ，Chung MY ，Wong SSM ，Chan OK ，Leung TY ... -  《-》

The application of prophylactic balloon occlusion of the internal iliac artery for the treatment of placenta accreta spectrum with placenta previa: a retrospective case-control study.

Peng Y ，Jiang L ，Peng C ，Wu D ，Chen L ... -  《BMC Pregnancy and Childbirth》

Conservative Management of Invasive Placenta Using Combined Prophylactic Internal Iliac Artery Balloon Occlusion and Immediate Postoperative Uterine Artery Embolization.

The objective of the study was to evaluate the efficacy and safety of combined prophylactic intraoperative internal iliac artery balloon occlusion and postoperative uterine artery embolization in the conservative management (uterine preservation) of women with invasive placenta undergoing scheduled caesarean delivery. Ten women (mean age 35 years) with invasive placenta choosing caesarean delivery without hysterectomy had preoperative insertion of internal iliac artery occlusion balloons, intraoperative inflation of the balloons, and immediate postoperative uterine artery embolization with absorbable gelatin sponge. A retrospective review was performed with institutional review board approval. Outcome measures were intraoperative blood loss, transfusion requirement, hysterectomy rate, endovascular complications, surgical complications, and postoperative morbidity. All women had placenta increta or percreta, and concomitant complete placenta previa. Mean gestational age at delivery was 36 weeks. In 6 women the placenta was left undisturbed in the uterus, 2 had partial removal of the placenta, and 2 had piecemeal removal of the whole placenta. Mean estimated blood loss during caesarean delivery was 1.2 L. Only 2 patients (20%) required blood transfusion. There were no intraoperative surgical complications, endovascular complications, maternal deaths, or perinatal deaths. Three women developed postpartum complications necessitating postpartum hysterectomy; the hysterectomy rate was therefore 30% and uterine preservation was successful in 70%. Combined bilateral internal iliac artery balloon occlusion and uterine artery embolization may be an effective strategy to control intraoperative blood loss and preserve the uterus in patients with invasive placenta undergoing caesarean delivery.

D'Souza DL ，Kingdom JC ，Amsalem H ，Beecroft JR ，Windrim RC ，Kachura JR ... -  《-》

Internal iliac artery balloon occlusion during cesarean hysterectomy in women with placenta previa accreta.

To investigate the effect of balloon occlusion of internal iliac arteries during cesarean hysterectomy in women with placenta previa accreta. Retrospective cohort study conducted using medical records of women with placenta previa and pathologically confirmed accreta taken from a single tertiary center in Chengdu, China, between January 1, 2012 and December 31, 2017. Baseline characteristics and pregnancy outcomes were compared between women with and without balloon occlusion of internal iliac arteries during cesarean delivery. The primary outcome was a composite outcome: estimated blood loss greater than or equal to 3.0 L, massive transfusion (transfusion of 10 or more units of packed red blood cells), and maternal intensive care unit admission. There were 114 patients included in the study, 83 (72.8%) in the balloon group and 31 (27.2%) in the control group. Both propensity score analysis (18 [78.3%] vs 15 [65.2%], P=0.326) and multivariate logistic analysis (adjusted odds ratio 0.54, 95% confidence interval 0.20-1.45; P=0.221) showed that intraoperative balloon occlusion of internal iliac arteries was not associated with the primary outcome. Balloon occlusion of internal iliac arteries during cesarean hysterectomy in women with placenta previa accreta was not associated with improved maternal outcomes.

Chen M ，Lv B ，He G ，Liu X ... -  《-》

Clinical evaluation of the effect for prophylactic balloon occlusion in pregnancies complicated with placenta accreta spectrum disorder: A systematic review and meta-analysis.

Placenta accreta spectrum (PAS) disorder is a critical and severe obstetric condition associated with high risk of intraoperative massive hemorrhage and cesarean hysterectomy. Severe obstetric hemorrhage is currently one of the leading causes of maternal death worldwide. Prophylactic balloon occlusions, including prophylactic balloon occlusion of the abdominal aorta (PBOAA) and prophylactic balloon occlusion of the internal iliac arteries (PBOIIA), are the most common means of controlling hemorrhage in patients with PAS disorder, but their effectiveness is still debated. A systematic review and meta-analysis were conducted to evaluate the clinical effectiveness of prophylactic balloon occlusion during cesarean section (CS) in improving maternal outcomes for PAS patients. MEDLINE, EMBASE, OVID, PubMed and the Cochrane Library were systematically searched from the inception dates to June 2022, using the keywords "placenta accreta spectrum disorder/morbidly adherent placenta (placenta previa, placenta accreta, placenta increta, placenta percreta), balloon occlusion, internal iliac arteries, abdominal aorta, hemorrhage, hysterectomy, estimated blood loss (EBL), packed red blood cells (PRBCs)" to identify the systematic reviews or meta-analyses. All articles regarding PAS disorders and including the application of balloon occlusion were included in the screening. Two independent researchers performed the data extraction and assessed study quality. EBL volume and PRBC transfusion volume was regarded as the primary endpoints. Random and fixed effects models were used for the meta-analysis (RRs and 95% CIs), and the Newcastle-Ottawa Scale was used for quality assessments. Of 429 studies identified, a total of 35 trials involving the application of balloon occlusion for patients with PAS disorder during CS were included. A total of 19 studies involving 935 patients who underwent PBOIIA were included in the PBOIIA group, and 851 patients were included in control 1 group. Ten studies including 428 patients with PAS who underwent PBOAA were allocated to the PBOAA group, and 324 patients without PBOAA were included in control 2 group. Simultaneously, we compared the effect on PBOAA and PBOIIA including seven studies, which referred to 267 cases in the PBOAA group and 313 cases in the PBOIIA group. The results showed that the PBOIIA group had a reduced EBL volume (MD: 342.06 mL, 95% CI: -509.90 to -174.23 mL, I2 = 77%, P < 0.0001) and PRBC volume (MD: -1.57 U, 95% CI: -2.49 to -0.66 U, I2 = 91%, P = 0.0008) than that in control 1 group. With regard to the EBL volume (MD: -926.42 mL, 95% CI: -1437.07 to -415.77 mL, I2 = 96%, P = 0.0004) and PRBC transfusion volume (MD: -2.42 U, 95% CI: -4.25 to -0.59 U, I2 = 99%, P = 0.009) we found significant differences between the PBOAA group and control 2 group. Prophylactic balloon occlusion (PBOAA and PBOIIA) had a significant effect on reducing intraoperative blood loss and blood transfusion volume in patients with PAS. Moreover, PBOAA was more effective than PBOIIA in reducing intraoperative blood loss (MD: -406.63 mL, 95% CI: -754.12 to -59.13 mL, I2 = 92%, P = 0.020), but no significant difference in controlling PRBCs (MD: -3.48 U, 95% CI: -8.90 to 1.95 U, I2 = 99%, P = 0.210) between the PBOIIA group and the PBOAA group. Hierarchical analysis was conducted by differentiating gestational weeks and maternal age to reduce the high heterogeneity of meta-analysis. Hierarchical analysis results demonstrated the heterogeneities of the study were reduced to some extent, and gestational weeks and maternal age might be the cause of increased heterogeneity. Prophylactic balloon occlusion is a safe and effective method to control hemorrhage and reduce PRBC transfusion volume for patients with PAS, and PBOAA could reduce more intraoperative blood loss than PBOIIA. However, we found no statistical difference in lessening packed red blood cell transfusion volume for PAS patients. Hence, preoperative prophylactic balloon occlusion is the recommended application for PAS patients in obstetric CSs. Furthermore, PBOAA is preferred for controlling intraoperative bleeding in patients with corresponding medical conditions.

Chen D ，Xu J ，Tian Y ，Ling Q ，Peng B ... -  《-》