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Temporary balloon occlusion of the internal iliac arteries to prevent massive hemorrhage during cesarean delivery among patients with placenta previa
International Journal of Gynecology and Obstetrics 128 (2015) 118–121
Contents lists available at ScienceDirect
International Journal of Gynecology and Obstetrics journal homepage: www.elsevier.com/locate/ijgo
CLINICAL ARTICLE
Temporary balloon occlusion of the internal iliac arteries to prevent massive hemorrhage during cesarean delivery among patients with placenta previa Evelien A. Broekman a,⁎, Henneke Versteeg b, Louwerens D. Vos c, Marja G. Dijksterhuis a, Dimitri N. Papatsonis a a b c
Department of Obstetrics and Gynecology, Amphia Hospital Breda, Breda, Netherlands Department of Medical and Clinical Psychology and Statistics, Tilburg University, Tilburg, Netherlands Department of Radiology, Amphia Hospital Breda, Breda, Netherlands
a r t i c l e
i n f o
Article history: Received 25 March 2014 Received in revised form 20 August 2014 Accepted 21 October 2014 Keywords: Blood loss Cesarean delivery Hemorrhage Anterior placenta previa Temporary balloon occlusion
a b s t r a c t Objective: To evaluate the effectiveness of temporary balloon occlusion of the internal iliac artery before uterine incision to prevent massive obstetric hemorrhage during cesarean delivery among patients with anterior placenta previa. Methods: In a retrospective cohort study conducted at Amphia Hospital Breda (Breda, Netherlands), data were analyzed from women with anterior placenta previa who delivered by cesarean between January 1, 2001, and September 30, 2012. Cases with and without balloon occlusion of the internal iliac artery were included. The primary outcomes were the amount of blood loss during cesarean delivery, drop of hemoglobin level, and blood loss of more than 1000 mL. Results: Of 68 eligible women, 42 (62%) had temporary balloon occlusion and 26 (38%) had no balloon occlusion. Median blood loss was 800 mL (interquartile range [IQR] 488–1113) in the balloon group and 1000 mL (IQR 694–1307) in the no balloon group (P = 0.06). Blood loss of 1000 mL or more was recorded in 16 (38%) women in the balloon group and 18 (69%) in the no balloon group (P = 0.01). Conclusion: Temporary balloon occlusion of the internal iliac artery before uterine incision during cesarean delivery could potentially reduce blood loss among patients with anterior placenta previa. Large, randomized controlled trials are needed to confirm the results. © 2014 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
1. Introduction With the increasing incidence of cesarean delivery across the world, the prevalence of complications due to abnormal placenta localization is also rising [1]. The prevalence of placenta previa ranges from 0.3% to 0.9% among patients who have not had a previous cesarean delivery, but increases to as much as 10% among patients who have undergone four or more cesareans [2–5]. Placentation in the lower uterine segment increases the chance of massive postpartum hemorrhage (N1000 mL), independent of the use of uterotonic agents [2,6,7]. The risk of massive blood loss during cesarean delivery is increased further in women with an anterior placenta previa, because the placenta has to be traversed before the neonate can be delivered. Massive blood loss is associated with increased maternal and neonatal morbidity and mortality [2]. Selective uterine artery embolization has been performed since 1979 to reduce the amount of blood loss among patients with placentaassociated pathology and persistent hemorrhage after vaginal delivery.
⁎ Corresponding author at: Department of Obstetrics and Gynecology, Amphia Hospital Breda, Langendijk 75, 4819 EV, Breda, Netherlands. Tel.: +31 76 5951000; fax: +31 76 5952467. E-mail address: [email protected] (E.A. Broekman).
Complications of embolization include vessel injury (dissection or rupture), hematoma, or pseudoaneurysm formation at the puncture site; non-target embolization; contrast-induced nephropathy; and/or allergic reactions [8–11]. The incidence of these complications has not been reported after delivery, but it might be more common among this group than among the overall population because arteries of pregnant women are more compliant and there is increased risk of a thromboembolism. An alternative method to occlude the uterine arteries is the use of temporary perioperative balloons in the internal iliac artery. Studies on balloon occlusion for patients with known or suspected placenta accreta during cesarean delivery or hysterectomy have shown mixed results [7,12,13]. Although guidelines suggest that this approach is a possible management option [2], in most studies the balloons were directly inflated after the neonate was delivered. To our knowledge, no study has evaluated the effectiveness of balloon occlusion for patients with anterior placenta previa at the time of incision in the lower uterine segment (i.e. seconds before delivery of the neonate). Owing to an increasing incidence of placenta previa at the Amphia Hospital Breda (Breda, Netherlands), the aim of the present study was to evaluate the effectiveness of temporary balloon occlusion of the internal iliac artery in preventing massive obstetric hemorrhage during cesarean delivery for patients with anterior placenta previa.
http://dx.doi.org/10.1016/j.ijgo.2014.08.021 0020-7292/© 2014 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
E.A. Broekman et al. / International Journal of Gynecology and Obstetrics 128 (2015) 118–121
2. Materials and methods A retrospective cohort study was performed using data obtained from the clinical obstetric database of the Amphia Hospital Breda. Women with a known anterior placenta previa who delivered a newborn by cesarean between January 1, 2001, and September 30, 2012, were included. Patients were excluded from analyses when information on the location of the placenta was missing. Because guidelines from different countries suggest that temporary balloon occlusion is a potential treatment option to prevent hemorrhage in patients with placenta previa [2,3], approval from the local ethics committee was not required. All patients gave informed consent before the procedure. The medical files of eligible patients were manually checked for maternal characteristics, such as the presence and position of the placenta previa, the use of temporary balloon occlusion, the amount of blood loss during cesarean delivery, and maternal and perinatal morbidity. Placenta previa had been diagnosed by second-trimester transvaginal sonography and then re-evaluated at 32 weeks. If placenta previa was still present, an elective cesarean was planned at 37 weeks of gestation, as recommended by Dutch national guidelines [3]. Since 2005, patients with an anterior placenta previa have been informed about the possibility of temporary balloon occlusion and its potential benefits [2]. Preoperatively, the potential benefits, possible complications, use of radiation during fluoroscopy, and contraindications of the procedure (i.e. contrast allergy or renal failure) were discussed with the patient. Approximately 1 hour before surgery was scheduled, the patient was transferred to the interventional radiology suite. Catheter placement was performed by certified vascular interventional radiologists. After local anesthesia, both femoral arteries were punctured via the Seldinger technique and 6-French sheaths (Cook, Bloomington, IN, USA) were put in place. Selective catheterization of the contralateral internal iliac artery was then done under fluoroscopic guidance and a 5.5French, semi-compliant over-the-wire Fogarty Thru-Lumen Embolectomy balloon catheter (Edwards Lifesciences, Irvine, CA, USA) (Fig. 1) was inserted. The balloons were positioned between the origin of the internal iliac artery and the bifurcation of the anterior and posterior division, which was angiographically confirmed by injecting 8 mL of 50% diluted contrast medium (Hexabrix 200, Guerbet, Roissy, France) retrograde through the sheaths. In cases of emergency cesarean, the patient was transferred directly to the operation theatre, and the catheters were put in place there. Cesarean procedures were performed by one of 15 consultant obstetricians of the Department of Obstetrics and Gynecology. For all patients, a low transverse incision was used. Before incision of the lower uterine segment, the interventional radiologist inflated the balloons with 2–3 mL of saline solution to stop the blood flow from the internal iliac artery to the uterine arteries. After the incision in the lower uterine segment, the neonate was delivered within 2 minutes. Immediately after delivery, 5 IU of intravenous oxytocin (Syntocinon, Sigma-Tau, Rome, Italy; 5 IU/mL) was given as a bolus. The placenta was delivered by
119
manual removal or by controlled cord traction. Hemostasis was obtained by manual pressure and, from 2010 onwards, vascular plugs (Angio-Seal, St Jude Medical, St Paul, MN, USA) were used. After the uterus was closed and hemostasis was obtained, the balloons were deflated. Within 12 hours of surgery, the catheters and sheaths were removed by the interventional radiologist. Radiation during pregnancy can potentially cause fetal damage. Adverse effects of radiation are mostly described in the first trimester of pregnancy: after 20–25 weeks of gestation, there are no known teratogenic effects. It is not clear which doses cause radiation damage, but doses below 100 mGy (10 rads [radiation absorbed dose]) seem to have no obvious effect on the fetus. This dose, which is comparable to at least three pelvic computed tomography scans or 20 pelvic radiographs, is generally not used. Clearly, radiation reduction techniques such as short fluoroscopy time, minimum frame rate per second, and smallest radiation area [14] should be applied. At the study hospital, the mean fluoroscopy exposure time for this procedure was 3.5 minutes (range, 1–10 minutes); for the mother, this dose is comparable to approximately five pelvic radiographs. In some cases, longer fluoroscopy times were caused by a steep angle of the aortic bifurcation; in one patient, for whom the fluoroscopy took 10 minutes, the right internal iliac artery originated from the aortic bifurcation [14]. The primary study outcomes were total amount of blood loss, change in hemoglobin level from before surgery to 1 day after surgery, and percentage of patients with blood loss of more than 1000 mL. Secondary outcomes were maternal and perinatal morbidity and mortality. Blood loss during surgery was measured by weighing compresses and blood collected by suction from the operation area (minus the amount of amniotic fluid) caught in measuring trays. Statistical analysis was carried out with SPSS version 19 (IBM, Armonk, NY, USA). Data are presented as mean ± SD or median (interquartile range [IQR]). To compare patients with and those without temporary balloon occlusion, Student t tests or the non-parametric Mann–Whitney U test (if applicable) were used for continuous variables, and the χ2 test or Fisher exact test (if applicable) was used for categorical variables. P b 0.05 was considered statistically significant. 3. Results Among 68 women with an anterior placenta previa who underwent cesarean delivery, 42 (62%) had temporary balloon occlusion (Fig. 2). Among the 26 who had no balloon occlusion, 14 (54%) delivered before 2005, when the balloon occlusion technique was introduced in the study hospital. The other 12 (46%) patients who did not undergo balloon occlusion but delivered after 2005 were admitted out of hours with acute blood loss, in labor, or with signs of fetal distress. Emergency cesareans were performed, and the attending obstetricians deemed that there was no time to undertake temporary balloon occlusion. There
Women with placenta previa who delivered by cesarean (n=136)
Posterior placenta previa (n=68) Balloon occlusion (n=6) No balloon occlusion (n=62) Anterior placenta previa (n=68)
Balloon occlusion (n=42) Fig. 1. The over-the-wire Fogarty Thru-Lumen Embolectomy catheter (Edwards Lifescience Irvine, CA, USA) used for temporary balloon occlusion of the internal iliac arteries during cesarean delivery among patients with placenta previa.
No balloon occlusion (n=26)
Fig. 2. Flow chart showing derivation of the study population of women with anterior placenta previa and cesarean delivery with or without balloon occlusion.
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E.A. Broekman et al. / International Journal of Gynecology and Obstetrics 128 (2015) 118–121
were no differences in baseline characteristics between those with and those without balloon occlusion (Table 1). There was no significant difference in the median total blood loss (P = 0.06) or drop in hemoglobin level (P = 0.09) between patients with and without balloon occlusion (Table 2). However, the percentage of patients who lost 1000 mL or more of blood was significantly lower in the balloon group (38%) than in the no balloon group (69%) (P = 0.01). With respect to secondary outcomes, no maternal complications were reported and there was no difference between the two groups in the amount of uterotonic agents used (P = 0.63) (Table 2). No major or minor complications related to the endovascular procedure were reported in either group. Moreover, perinatal outcomes with respect to Apgar scores, and umbilical artery pH and base excess were similar in the two groups (Table 2). The median total blood loss was significantly higher in the group with anterior placenta previa than in the group with posterior placenta previa (1008 mL [IQR 752–1264] versus 797 mL [IQR 520–1074]; P = 0.02).
4. Discussion In the present study, temporary balloon occlusion of the internal iliac artery before uterine incision during cesarean delivery for patients with anterior placenta previa seemed to be associated with a reduction in total blood loss and a smaller drop in hemoglobin levels, although the differences were not significant. Nevertheless, the percentage of patients whose blood loss was 1000 mL or more in the no balloon group was nearly double that in the balloon group. The total occlusion time while the fetus was in utero was short (b 2 minutes), and no difference in perinatal outcome was seen between the two groups. Studies evaluating the influence of temporary balloon occlusion of the internal iliac artery for patients with placenta accreta who then underwent hysterectomy have reported mixed results in the reduction of blood loss [8,13]. In those studies, however, the balloons were inflated after delivery of the newborn [8,13], whereas in the present study the balloons were inflated before the uterine incision was made. Occlusion of the uterine arteries via inflated balloons in the internal iliac artery does not completely stop blood flow to the uterus owing to collateral blood vessels or anastomosis. Salazar et al. [11] concluded that transcatheter embolization is an effective way to control uterine bleeding, although the collateral blood supply remains [11]. This collateral blood supply and the short period of balloon occlusion for the fetus probably account for the lack of differences in perinatal outcome in the present study. The clinical purpose of lowering blood loss during cesarean delivery is to reduce maternal morbidity, including a decreased need for packed cells, fewer maternal hospital days, and quicker recovery of the mother at home. In the present study, the difference in mean blood loss between the balloon group and the no balloon group was 200 mL, which has considerable clinical significance.
Table 1 Baseline characteristics.a Characteristic
Balloon group (n = 42)
No balloon group (n = 26)
P value
Maternal age, y Primipara Gestational age at delivery, d Previous cesarean delivery Hypertension disorders during pregnancyb Third trimester blood loss Emergency operation
32.6 ± 4.3 17 (40) 259 (255–264) 9 (21) 2 (5)
34.1 ± 3.7 8 (31) 264 (257–272) 4 (15) 0
0.14 0.42 0.16 0.75 0.53
31 (74) 9 (21)
20 (77) 11 (42)
0.77 0.06
a b
Values are given as mean ± SD, number (percentage), or median (interquartile range). Hypertensive disorders such as pregnancy-related hypertension and pre-eclampsia.
Table 2 Primary and secondary outcomes.a Variable
Balloon group (n = 42)
No balloon group (n = 26)
P value
Total blood loss, mL Total amount of blood loss ≥1000 mL Decrease in hemoglobin after surgery, mmol/L No. of transfusions of packed RBCs 1 2 3 4 Operation time, min Use of uterotonics during operationb Total admission time, d Other complicationsc Birth weight, g Apgar score b4 after 5 min Umbilical artery pH d Umbilical artery BEd
800 (488–1113) 16 (38)
1000 (694–1307) 18 (69)
0.06 0.01
1.10 (0.65–1.55)
1.20 (0.85–1.55)
0.09 0.14
2 (5) 1 (2) 1 (2) 0 45 (40–50) 17 (40)
0 4 (15) 1 (4) 1 (4) 45 (50–61) 9 (35)
0.20 0.63
5 (3–6) 0 3015 (2790–3241) 0 7.26 ± 0.05 −3.8 ± 1.9
5 (4–6) 0 3010 (2718–3303) 0 7.29 ± 0.09 −3.2 ± 2.8
0.15 – 0.40 – 0.30 0.49
Abbreviations: RBC, red blood cell; BE, base excess. a Values are given as number (percentage), median (interquartile range), or mean ± SD. b The uterotonic agent was Nalador (sulprostone) infusion, oxytocin infusion, or 5 IU intravenous oxytocin. c Other complications included re-operation, placement of Bakri balloon, and maternal admission to the intensive care unit. d Umbilical artery pH and BE values were measured from the umbilical cord directly after the neonate was delivered.
Complications of temporary balloon occlusion have been described and are possibly more common among pregnant women than among the overall population because of changes in blood flow and a hypercoagulable state [15]. Serious maternal thromboembolic events have been reported in case reports describing the use of balloon catheters [15]. Therefore, the potential benefits of a decrease in blood loss must be weighed against the invasive character of this technique for the patients and the risk of (severe) maternal complications [8,16]. There were no major or minor complications due to the endovascular procedure in the present study group. The present study has some limitations. Because of the fairly low incidence of placenta previa, the number of patients in the analysis was small. In addition, some patients had to be excluded from analysis because data regarding the position of the placenta previa were missing. The strengths of the present study are the objective methods used to measure both the drop in hemoglobin level after surgery and the blood loss during surgery, which included weighing the gauzes, and collecting and measuring the amount of blood that was suctioned from the operation site. In conclusion, the results of the present study suggest that temporary balloon occlusion of the internal iliac artery can lead to reduced blood loss for patients with anterior placenta previa without adverse effects for the neonate. To determine whether temporary balloon occlusion can be used as a standard procedure either for all patients or for a subgroup of patients with placenta previa (i.e. those with anterior placenta location, multiple prior cesarean procedures, or a history of hemorrhage), further research is needed in the form of a large multicenter randomized controlled trial. In such a study, maternal and perinatal complications resulting from the procedure, and patient satisfaction should be investigated.
Conflict of interest The authors have no conflicts of interest.
E.A. Broekman et al. / International Journal of Gynecology and Obstetrics 128 (2015) 118–121
References [1] Allahdin S, Voigt S, Htwe TT. Management of placenta praevia and accreta. J Obstet Gynaecol 2011;31(1):1–6. [2] Royal College of Obstetricians and Gynaecologists. Placenta praevia, placenta praevia accreta and vasa praevia: diagnosis and management: Green-top Guideline No. 27. https://www.rcog.org.uk/globalassets/documents/guidelines/gtg27placentapraeviajanuary2011.pdf; Published January 2011. Accessed August 15, 2014. [3] Dutch Society of Gynaecology and Obstetrics (NVOG). Blood loss in the second half of pregnancy. (in Dutch) http://nvog-documenten.nl/richtlijn/doc/index.php?type= save&richtlijn_id=797; Published March 2008. Accessed August 15, 2014. [4] Bhide A, Thilaganathan B. Recent advances in the management of placenta previa. Curr Opin Obstet Gynecol 2004;16(6):447–51. [5] Clark SL, Koonings PP, Phelan JP. Placenta previa/accreta and prior cesarean section. Obstet Gynecol 1985;66(1):89–92. [6] Iyasu S, Saftlas AK, Rowley DL, Koonin LM, Lawson HW, Atrash HK. The epidemiology of placenta previa in the United States, 1979 through 1987. Am J Obstet Gynecol 1993;168(5):1424–9. [7] Oyelese Y, Smulian JC. Placenta previa, placenta accreta, and vasa previa. Obstet Gynecol 2006;107(4):927–41. [8] Bishop S, Butler K, Monaghan S, Chan K, Murphy G, Edozien L. Multiple complications following the use of prophylactic internal iliac artery balloon catheterisation in a patient with placenta percreta. Int J Obstet Anesth 2011;20(1):70–3.
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[9] Bodner LJ, Nosher JL, Gribbin C, Siegel RL, Beale S, Scorza W. Balloon-assisted occlusion of the internal iliac arteries in patients with placenta accreta/percreta. Cardiovasc Intervent Radiol 2006;29(3):354–61. [10] Ojala K, Perälä J, Kariniemi J, Ranta P, Raudaskoski T, Tekay A. Arterial embolization and prophylactic catheterization for the treatment for severe obstetric hemorrhage. Acta Obstet Gynecol Scand 2005;84(11):1075–80. [11] Salazar GM, Petrozza JC, Walker TG. Transcatheter endovascular techniques for management of obstetrical and gynecologic emergencies. Tech Vasc Interv Radiol 2009; 12(2):139–47. [12] Tan CH, Tay KH, Sheah K, Kwek K, Wong K, Tan HK, et al. Perioperative endovascular internal iliac artery occlusion balloon placement in management of placenta accreta. AJR Am J Roentgenol 2007;189(5):1158–63. [13] Carnevale FC, Kondo MM, de Oliveira Sousa Jr W, Santos AB, da Motta Leal Filho JM, Moreira AM, et al. Perioperative temporary occlusion of the internal iliac arteries as prophylaxis in cesarean section at risk of hemorrhage in placenta accreta. Cardiovasc Intervent Radiol 2011;34(4):758–64. [14] Valentin J. Effects of in utero irradiation. Ann ICRP 2000;30(1):9–12. [15] Dilauro MD, Dason S, Athreya S. Prophylactic balloon occlusion of internal iliac arteries in women with placenta accreta: literature review and analysis. Clin Radiol 2012; 67(6):515–20. [16] Teare J, Evans E, Belli A, Wendler R. Sciatic nerve ischaemia after iliac artery occlusion balloon catheter placement for placenta percreta. Int J Obstet Anesth 2014; 23(2):178–81.
Contents lists available at ScienceDirect
International Journal of Gynecology and Obstetrics journal homepage: www.elsevier.com/locate/ijgo
CLINICAL ARTICLE
Temporary balloon occlusion of the internal iliac arteries to prevent massive hemorrhage during cesarean delivery among patients with placenta previa Evelien A. Broekman a,⁎, Henneke Versteeg b, Louwerens D. Vos c, Marja G. Dijksterhuis a, Dimitri N. Papatsonis a a b c
Department of Obstetrics and Gynecology, Amphia Hospital Breda, Breda, Netherlands Department of Medical and Clinical Psychology and Statistics, Tilburg University, Tilburg, Netherlands Department of Radiology, Amphia Hospital Breda, Breda, Netherlands
a r t i c l e
i n f o
Article history: Received 25 March 2014 Received in revised form 20 August 2014 Accepted 21 October 2014 Keywords: Blood loss Cesarean delivery Hemorrhage Anterior placenta previa Temporary balloon occlusion
a b s t r a c t Objective: To evaluate the effectiveness of temporary balloon occlusion of the internal iliac artery before uterine incision to prevent massive obstetric hemorrhage during cesarean delivery among patients with anterior placenta previa. Methods: In a retrospective cohort study conducted at Amphia Hospital Breda (Breda, Netherlands), data were analyzed from women with anterior placenta previa who delivered by cesarean between January 1, 2001, and September 30, 2012. Cases with and without balloon occlusion of the internal iliac artery were included. The primary outcomes were the amount of blood loss during cesarean delivery, drop of hemoglobin level, and blood loss of more than 1000 mL. Results: Of 68 eligible women, 42 (62%) had temporary balloon occlusion and 26 (38%) had no balloon occlusion. Median blood loss was 800 mL (interquartile range [IQR] 488–1113) in the balloon group and 1000 mL (IQR 694–1307) in the no balloon group (P = 0.06). Blood loss of 1000 mL or more was recorded in 16 (38%) women in the balloon group and 18 (69%) in the no balloon group (P = 0.01). Conclusion: Temporary balloon occlusion of the internal iliac artery before uterine incision during cesarean delivery could potentially reduce blood loss among patients with anterior placenta previa. Large, randomized controlled trials are needed to confirm the results. © 2014 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
1. Introduction With the increasing incidence of cesarean delivery across the world, the prevalence of complications due to abnormal placenta localization is also rising [1]. The prevalence of placenta previa ranges from 0.3% to 0.9% among patients who have not had a previous cesarean delivery, but increases to as much as 10% among patients who have undergone four or more cesareans [2–5]. Placentation in the lower uterine segment increases the chance of massive postpartum hemorrhage (N1000 mL), independent of the use of uterotonic agents [2,6,7]. The risk of massive blood loss during cesarean delivery is increased further in women with an anterior placenta previa, because the placenta has to be traversed before the neonate can be delivered. Massive blood loss is associated with increased maternal and neonatal morbidity and mortality [2]. Selective uterine artery embolization has been performed since 1979 to reduce the amount of blood loss among patients with placentaassociated pathology and persistent hemorrhage after vaginal delivery.
⁎ Corresponding author at: Department of Obstetrics and Gynecology, Amphia Hospital Breda, Langendijk 75, 4819 EV, Breda, Netherlands. Tel.: +31 76 5951000; fax: +31 76 5952467. E-mail address: [email protected] (E.A. Broekman).
Complications of embolization include vessel injury (dissection or rupture), hematoma, or pseudoaneurysm formation at the puncture site; non-target embolization; contrast-induced nephropathy; and/or allergic reactions [8–11]. The incidence of these complications has not been reported after delivery, but it might be more common among this group than among the overall population because arteries of pregnant women are more compliant and there is increased risk of a thromboembolism. An alternative method to occlude the uterine arteries is the use of temporary perioperative balloons in the internal iliac artery. Studies on balloon occlusion for patients with known or suspected placenta accreta during cesarean delivery or hysterectomy have shown mixed results [7,12,13]. Although guidelines suggest that this approach is a possible management option [2], in most studies the balloons were directly inflated after the neonate was delivered. To our knowledge, no study has evaluated the effectiveness of balloon occlusion for patients with anterior placenta previa at the time of incision in the lower uterine segment (i.e. seconds before delivery of the neonate). Owing to an increasing incidence of placenta previa at the Amphia Hospital Breda (Breda, Netherlands), the aim of the present study was to evaluate the effectiveness of temporary balloon occlusion of the internal iliac artery in preventing massive obstetric hemorrhage during cesarean delivery for patients with anterior placenta previa.
http://dx.doi.org/10.1016/j.ijgo.2014.08.021 0020-7292/© 2014 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
E.A. Broekman et al. / International Journal of Gynecology and Obstetrics 128 (2015) 118–121
2. Materials and methods A retrospective cohort study was performed using data obtained from the clinical obstetric database of the Amphia Hospital Breda. Women with a known anterior placenta previa who delivered a newborn by cesarean between January 1, 2001, and September 30, 2012, were included. Patients were excluded from analyses when information on the location of the placenta was missing. Because guidelines from different countries suggest that temporary balloon occlusion is a potential treatment option to prevent hemorrhage in patients with placenta previa [2,3], approval from the local ethics committee was not required. All patients gave informed consent before the procedure. The medical files of eligible patients were manually checked for maternal characteristics, such as the presence and position of the placenta previa, the use of temporary balloon occlusion, the amount of blood loss during cesarean delivery, and maternal and perinatal morbidity. Placenta previa had been diagnosed by second-trimester transvaginal sonography and then re-evaluated at 32 weeks. If placenta previa was still present, an elective cesarean was planned at 37 weeks of gestation, as recommended by Dutch national guidelines [3]. Since 2005, patients with an anterior placenta previa have been informed about the possibility of temporary balloon occlusion and its potential benefits [2]. Preoperatively, the potential benefits, possible complications, use of radiation during fluoroscopy, and contraindications of the procedure (i.e. contrast allergy or renal failure) were discussed with the patient. Approximately 1 hour before surgery was scheduled, the patient was transferred to the interventional radiology suite. Catheter placement was performed by certified vascular interventional radiologists. After local anesthesia, both femoral arteries were punctured via the Seldinger technique and 6-French sheaths (Cook, Bloomington, IN, USA) were put in place. Selective catheterization of the contralateral internal iliac artery was then done under fluoroscopic guidance and a 5.5French, semi-compliant over-the-wire Fogarty Thru-Lumen Embolectomy balloon catheter (Edwards Lifesciences, Irvine, CA, USA) (Fig. 1) was inserted. The balloons were positioned between the origin of the internal iliac artery and the bifurcation of the anterior and posterior division, which was angiographically confirmed by injecting 8 mL of 50% diluted contrast medium (Hexabrix 200, Guerbet, Roissy, France) retrograde through the sheaths. In cases of emergency cesarean, the patient was transferred directly to the operation theatre, and the catheters were put in place there. Cesarean procedures were performed by one of 15 consultant obstetricians of the Department of Obstetrics and Gynecology. For all patients, a low transverse incision was used. Before incision of the lower uterine segment, the interventional radiologist inflated the balloons with 2–3 mL of saline solution to stop the blood flow from the internal iliac artery to the uterine arteries. After the incision in the lower uterine segment, the neonate was delivered within 2 minutes. Immediately after delivery, 5 IU of intravenous oxytocin (Syntocinon, Sigma-Tau, Rome, Italy; 5 IU/mL) was given as a bolus. The placenta was delivered by
119
manual removal or by controlled cord traction. Hemostasis was obtained by manual pressure and, from 2010 onwards, vascular plugs (Angio-Seal, St Jude Medical, St Paul, MN, USA) were used. After the uterus was closed and hemostasis was obtained, the balloons were deflated. Within 12 hours of surgery, the catheters and sheaths were removed by the interventional radiologist. Radiation during pregnancy can potentially cause fetal damage. Adverse effects of radiation are mostly described in the first trimester of pregnancy: after 20–25 weeks of gestation, there are no known teratogenic effects. It is not clear which doses cause radiation damage, but doses below 100 mGy (10 rads [radiation absorbed dose]) seem to have no obvious effect on the fetus. This dose, which is comparable to at least three pelvic computed tomography scans or 20 pelvic radiographs, is generally not used. Clearly, radiation reduction techniques such as short fluoroscopy time, minimum frame rate per second, and smallest radiation area [14] should be applied. At the study hospital, the mean fluoroscopy exposure time for this procedure was 3.5 minutes (range, 1–10 minutes); for the mother, this dose is comparable to approximately five pelvic radiographs. In some cases, longer fluoroscopy times were caused by a steep angle of the aortic bifurcation; in one patient, for whom the fluoroscopy took 10 minutes, the right internal iliac artery originated from the aortic bifurcation [14]. The primary study outcomes were total amount of blood loss, change in hemoglobin level from before surgery to 1 day after surgery, and percentage of patients with blood loss of more than 1000 mL. Secondary outcomes were maternal and perinatal morbidity and mortality. Blood loss during surgery was measured by weighing compresses and blood collected by suction from the operation area (minus the amount of amniotic fluid) caught in measuring trays. Statistical analysis was carried out with SPSS version 19 (IBM, Armonk, NY, USA). Data are presented as mean ± SD or median (interquartile range [IQR]). To compare patients with and those without temporary balloon occlusion, Student t tests or the non-parametric Mann–Whitney U test (if applicable) were used for continuous variables, and the χ2 test or Fisher exact test (if applicable) was used for categorical variables. P b 0.05 was considered statistically significant. 3. Results Among 68 women with an anterior placenta previa who underwent cesarean delivery, 42 (62%) had temporary balloon occlusion (Fig. 2). Among the 26 who had no balloon occlusion, 14 (54%) delivered before 2005, when the balloon occlusion technique was introduced in the study hospital. The other 12 (46%) patients who did not undergo balloon occlusion but delivered after 2005 were admitted out of hours with acute blood loss, in labor, or with signs of fetal distress. Emergency cesareans were performed, and the attending obstetricians deemed that there was no time to undertake temporary balloon occlusion. There
Women with placenta previa who delivered by cesarean (n=136)
Posterior placenta previa (n=68) Balloon occlusion (n=6) No balloon occlusion (n=62) Anterior placenta previa (n=68)
Balloon occlusion (n=42) Fig. 1. The over-the-wire Fogarty Thru-Lumen Embolectomy catheter (Edwards Lifescience Irvine, CA, USA) used for temporary balloon occlusion of the internal iliac arteries during cesarean delivery among patients with placenta previa.
No balloon occlusion (n=26)
Fig. 2. Flow chart showing derivation of the study population of women with anterior placenta previa and cesarean delivery with or without balloon occlusion.
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were no differences in baseline characteristics between those with and those without balloon occlusion (Table 1). There was no significant difference in the median total blood loss (P = 0.06) or drop in hemoglobin level (P = 0.09) between patients with and without balloon occlusion (Table 2). However, the percentage of patients who lost 1000 mL or more of blood was significantly lower in the balloon group (38%) than in the no balloon group (69%) (P = 0.01). With respect to secondary outcomes, no maternal complications were reported and there was no difference between the two groups in the amount of uterotonic agents used (P = 0.63) (Table 2). No major or minor complications related to the endovascular procedure were reported in either group. Moreover, perinatal outcomes with respect to Apgar scores, and umbilical artery pH and base excess were similar in the two groups (Table 2). The median total blood loss was significantly higher in the group with anterior placenta previa than in the group with posterior placenta previa (1008 mL [IQR 752–1264] versus 797 mL [IQR 520–1074]; P = 0.02).
4. Discussion In the present study, temporary balloon occlusion of the internal iliac artery before uterine incision during cesarean delivery for patients with anterior placenta previa seemed to be associated with a reduction in total blood loss and a smaller drop in hemoglobin levels, although the differences were not significant. Nevertheless, the percentage of patients whose blood loss was 1000 mL or more in the no balloon group was nearly double that in the balloon group. The total occlusion time while the fetus was in utero was short (b 2 minutes), and no difference in perinatal outcome was seen between the two groups. Studies evaluating the influence of temporary balloon occlusion of the internal iliac artery for patients with placenta accreta who then underwent hysterectomy have reported mixed results in the reduction of blood loss [8,13]. In those studies, however, the balloons were inflated after delivery of the newborn [8,13], whereas in the present study the balloons were inflated before the uterine incision was made. Occlusion of the uterine arteries via inflated balloons in the internal iliac artery does not completely stop blood flow to the uterus owing to collateral blood vessels or anastomosis. Salazar et al. [11] concluded that transcatheter embolization is an effective way to control uterine bleeding, although the collateral blood supply remains [11]. This collateral blood supply and the short period of balloon occlusion for the fetus probably account for the lack of differences in perinatal outcome in the present study. The clinical purpose of lowering blood loss during cesarean delivery is to reduce maternal morbidity, including a decreased need for packed cells, fewer maternal hospital days, and quicker recovery of the mother at home. In the present study, the difference in mean blood loss between the balloon group and the no balloon group was 200 mL, which has considerable clinical significance.
Table 1 Baseline characteristics.a Characteristic
Balloon group (n = 42)
No balloon group (n = 26)
P value
Maternal age, y Primipara Gestational age at delivery, d Previous cesarean delivery Hypertension disorders during pregnancyb Third trimester blood loss Emergency operation
32.6 ± 4.3 17 (40) 259 (255–264) 9 (21) 2 (5)
34.1 ± 3.7 8 (31) 264 (257–272) 4 (15) 0
0.14 0.42 0.16 0.75 0.53
31 (74) 9 (21)
20 (77) 11 (42)
0.77 0.06
a b
Values are given as mean ± SD, number (percentage), or median (interquartile range). Hypertensive disorders such as pregnancy-related hypertension and pre-eclampsia.
Table 2 Primary and secondary outcomes.a Variable
Balloon group (n = 42)
No balloon group (n = 26)
P value
Total blood loss, mL Total amount of blood loss ≥1000 mL Decrease in hemoglobin after surgery, mmol/L No. of transfusions of packed RBCs 1 2 3 4 Operation time, min Use of uterotonics during operationb Total admission time, d Other complicationsc Birth weight, g Apgar score b4 after 5 min Umbilical artery pH d Umbilical artery BEd
800 (488–1113) 16 (38)
1000 (694–1307) 18 (69)
0.06 0.01
1.10 (0.65–1.55)
1.20 (0.85–1.55)
0.09 0.14
2 (5) 1 (2) 1 (2) 0 45 (40–50) 17 (40)
0 4 (15) 1 (4) 1 (4) 45 (50–61) 9 (35)
0.20 0.63
5 (3–6) 0 3015 (2790–3241) 0 7.26 ± 0.05 −3.8 ± 1.9
5 (4–6) 0 3010 (2718–3303) 0 7.29 ± 0.09 −3.2 ± 2.8
0.15 – 0.40 – 0.30 0.49
Abbreviations: RBC, red blood cell; BE, base excess. a Values are given as number (percentage), median (interquartile range), or mean ± SD. b The uterotonic agent was Nalador (sulprostone) infusion, oxytocin infusion, or 5 IU intravenous oxytocin. c Other complications included re-operation, placement of Bakri balloon, and maternal admission to the intensive care unit. d Umbilical artery pH and BE values were measured from the umbilical cord directly after the neonate was delivered.
Complications of temporary balloon occlusion have been described and are possibly more common among pregnant women than among the overall population because of changes in blood flow and a hypercoagulable state [15]. Serious maternal thromboembolic events have been reported in case reports describing the use of balloon catheters [15]. Therefore, the potential benefits of a decrease in blood loss must be weighed against the invasive character of this technique for the patients and the risk of (severe) maternal complications [8,16]. There were no major or minor complications due to the endovascular procedure in the present study group. The present study has some limitations. Because of the fairly low incidence of placenta previa, the number of patients in the analysis was small. In addition, some patients had to be excluded from analysis because data regarding the position of the placenta previa were missing. The strengths of the present study are the objective methods used to measure both the drop in hemoglobin level after surgery and the blood loss during surgery, which included weighing the gauzes, and collecting and measuring the amount of blood that was suctioned from the operation site. In conclusion, the results of the present study suggest that temporary balloon occlusion of the internal iliac artery can lead to reduced blood loss for patients with anterior placenta previa without adverse effects for the neonate. To determine whether temporary balloon occlusion can be used as a standard procedure either for all patients or for a subgroup of patients with placenta previa (i.e. those with anterior placenta location, multiple prior cesarean procedures, or a history of hemorrhage), further research is needed in the form of a large multicenter randomized controlled trial. In such a study, maternal and perinatal complications resulting from the procedure, and patient satisfaction should be investigated.
Conflict of interest The authors have no conflicts of interest.
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