Central Medical Journal of Obstetrics and Gynecology

Cite this article: Chowdary P, Makary M, McDougall J, Buckley B (2017) The Management of Obstetric Haemorrhage with Internal Illiac Balloon Catheters Secondary to Abnormal Placentation: A 5 Year Prospective Cohort Study. Med J Obstet Gynecol 5(4): 1111.

*Corresponding authorPrathima Chowdary, Obstetrics and Gynecology, Auckland City Hospital, New Zealand, Tel: 61470433777; Email Id:

Submitted: 09 August 2017

Accepted: 15 October 2017

Published: 17 October 2017

ISSN: 2333-6439

Copyright© 2017 Chowdary et al.

OPEN ACCESS

Research Article

The Management of Obstetric Haemorrhage with Internal Illiac Balloon Catheters Secondary to Abnormal Placentation: A 5 Year Prospective Cohort StudyPrathima Chowdary1*, Michael Makary1, Jenny McDougall1, and Brendan Buckley2

1Department of Obstetrics and Gynecology, Auckland City Hospital, New Zealand2Department of Interventional Radiology, Auckland City Hospital, New Zealand

Keywords•Placenta accrete•Increta•Percreta•Morbidly adherent placenta•Balloon•Interventional radiology•Embolisation•Caesarean hysterectomy

INTRODUCTIONThe aim of the study is to determine if the use of iliac artery

occlusion balloons (IAOB) reduce the volume of blood loss secondary to obstetric haemorrhage from abnormal placentation (placenta increta and percreta).

The goal of placing IAOB by Interventional Radiology (IR) treatment is based on the concept of reducing arterial perfusion pressure to uterus and placenta and cause temporary occlusion of proximal vessels.

Arterial occlusion balloons have been used in the setting of abnormal placentation for over 30 years with different approaches, from uterine artery occlusion to aortic occlusion. While more proximal balloons will occlude more collateral supply to the uterus the associated risks also increase. Different

centres have decided on the optimal location according to their assessment of the risk versus benefit. Following discussion between obstetrics, interventional radiology and vascular surgery it was decided to use internal iliac artery occlusion balloons.

We compared patient outcomes with data on patients diagnosed with abnormal placentation at delivery/surgery placement of IAOB with historical data from Auckland City Hospital. This study could serve as a pilot study for a multicentre randomised controlled trial investigating the place of iliac balloon catheters in the management of abnormal placentation.

MATERIALS AND METHODSThe study is a prospective cohort study (Canadian Task Force

Classification II), with the protocol for inclusion of patients as

Abstract

Objective: To examine the effect of prophylactic iliac artery occlusion balloon catheters on bleeding morbidity among women with a prenatal diagnosis of placenta accreta.

Methods: In a prospective trial (Canadian Task Force Classification II), women with a prenatal diagnosis of placenta accreta underwent a Multi-disciplinary Advisory Group (MDAG) review process and a decision was made regarding iliac artery occlusion balloons (IAOB) and caesarean hysterectomy. The primary study outcome was the measurement of blood loss. To detect difference in the blood loss between the prospective and retrospective group.

Results: Between March 2010 and March 2015, 14 patients were prospectively followed after MDAG review and decision to offer IAOB. During the same period 26 patients with abnormal placentation who did not have MDAG group review and in whom IAOB were not used were retrospectively studied. Demographic and obstetric characteristics were similar between the groups. All statistical tests were two-sided at a 5% significance level. Demographic and clinical characteristics of all patients were summarized by cohorts. Continuous variables were presented as mean, standard deviation, median and range. For those measured on both cohorts, statistical difference was assessed using the Fisher’s exact test on categorical variables, and two sample t-test on continuous variables. Model-estimated difference between the means was tested, with associated 95% confidence interval and p-value.

Conclusion: In women with preoperative suspicion of placenta accreta, MDAG review with an operative plan and placement of prophylactic balloon catheters significantly reduced the estimated blood loss operation.

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follows.

Patients with suspected abnormal placentation identified on obstetric ultrasound, and/or with clinical risk factors for abnormal placentation (multiple caesarean sections & uterine instrumentation) had high quality imaging with US and Magnetic Resonance Imaging (MRI) of the placenta to confirm the diagnosis and assess the extent of placental invasion (accreta, increta, percreta). Patients with a high suspicion of confirmed placenta accreta were reviewed by a Multi-disciplinary Advisory Group (MDAG), consisting of: the operating obstetric surgeon; a placental imaging expert; a senior gynaecologist; an anaesthetist; an interventional radiologist; a co-ordinator (mid-wife or nurse); and a Vascular and Urological surgeon if indicated.

If a decision was made that IAOB might assist in reducing haemorrhage, the patient was offered recruitment into the study. Pre-defined protocols were then applied for the insertion, use and removal of the IAOB and for data collection.

This prospective trial was conducted at a university teaching medical center in Auckland, New Zealand. The study was approved by the local institutional review board, Review and Research Committee, Health and Disability Ethics Committee and Maori Committee.

Patients were consented for the study in antenatal clinic or pre-operatively, a study booklet was provided as written information. This included contacts and was available in different languages. There was a senior registrar collecting the data at the time of surgery and immediately post operatively and on day 1 and day 3. This was entered in the data collection booklet.

To avoid emergent delivery, cesarean delivery was planned at 36-38 weeks of gestation, unless indicated before as a result of fetal or maternal indications. Antenatal corticosteroids were administered before delivery if the gestation was under 34 weeks, if not previously. Caesarean hysterectomy was offered to all participating women. A written protocol documented detailed instructions for IAOB placement to endure a standard approach for each patient. All balloon catheter placements were performed in the angiography suite by the same interventional radiologist (B.B) on the morning of elective delivery. The technique involved ultrasound guided bilateral femoral arterial punctures and insertion of 6-French vascular sheaths under local anesthesia. A 5-French cobra-shaped catheter was used to cannulate the contralateral internal iliac artery and a 5-French Le Maitre over-the-wire Embolectomy Catheter (LeMaitre Vascular, Burlington, MA, USA) positioned in the anterior division of the contralateral internal iliac artery. Once both balloon catheters were correctly positioned a test inflation was performed to document the volume required in each balloon to provide vessel occlusion. The sheaths were then flushed, stitched, and dressed to minimize the risk of dislodgement during the woman’s transfer. Intraoperatively, the balloons were inflated in all patients at the time of cord clamping after delivery of the neonate by the same radiologist with the test volume of normal saline combined with contrast medium and were left inflated until the operating surgeon requested that they be deflated. An operating theatre clock was started at the time of IAOB inflation with an upper limit of 90min for balloon inflation.

Postoperatively, following stabilization in the recovery room of obstetric high dependency unit, the balloons and femoral arterial sheaths were removed and haemostasis achieved with manual compression.

Women underwent cesarean delivery in the operating room immediately after balloon placement. Preoperative preparations in the operating room included insertion of two large-bore intravenous catheters, central venous line access, and arterial line for hemodynamic monitoring. Additionally, equipment for rapid infusion of blood products, pneumatic compression stockings, and a patient warming device were available. An adequate number of blood units were available in the operating room. As a result of the potential for severe hemorrhage and prolonged surgery, general anesthesia was used for all women. Preoperative cystoscopy and ureteric stent placement were done by the urologist prior to transfer to IR and placement of IAOB to minimize the risk of balloon displacement.

After delivery of the neonate, the balloons were inflated by the same interventional radiologist, regardless of the severity of bleeding. A gentle attempt was made to detach the placenta by application of controlled cord traction. In the event of failed placental detachment, the cord was clamped close to its origin and the uterine incision was sutured. No attempt was made at the time of operation to determine level of placental invasion because of risk of bleeding invasion.

Placenta accreta was confirmed during cesarean delivery in the presence of marked vascularisation and failed placental detachment and by pathologic examination of the removed uterus.

The primary study outcome was the estimated blood loss. This was measured with weighing of the swabs, cell saver and suction. This was monitored by two nurses and the senior registrar present in theatre doing the data collection (Figure 1-3).

LITERATURE REVIEWThough rare, the incidence of placenta accreta/increta/

percreta has increased rapidly over the past 30 years, historically quoted as being as rare as 1:30,000 pregnancies, to 1:2000-4000 in the 1970’s, and up to as commonly as 1:553 pregnancies at the turn of the century [1,2]. This increase in incidence is largely due to the increasing risk factors of increased rate of caesarean section and increasing maternal age [2]. Fortunately imaging techniques and expertise in assessing these images means when suspected we can now, with reasonable accuracy, identify placenta accreta/increta/percreta antenatally before experiencing massive unexpected haemorrhage at the time of attempted placental separation [3,4].

Given early identification of a morbidly adherent placenta, the mainstays of management are careful planning for delivery by caesarean section, and often by caesarean hysterectomy, with an emphasis on planning to optimise management of the expected major blood loss [5,6]. Studies attempting to estimate blood loss associated with placenta accreta have shown consistently high requirements for blood component transfusions, with one study finding blood transfusion was required in 95% of cases of placenta accreta, and a mean blood transfusion requirement

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of 10 units of packed red cells [7]. High blood loss and high requirement for blood transfusion still seems to be present even with antenatal identification and planned optimal management, with one study finding an average estimated blood loss of 2.3L and mean red blood cell transfusion of 4.7u for cases of planned en bloc hysterectomy without removal of the placenta for cases of placenta accreta that had been diagnosed pre-delivery [8].

A strategy which aims to reduce blood loss at the time of surgery, and was first described in 1997, involves prophylactic placement of IAOB prior to planned surgery (caesarean section +/- other), with inflation of the vascular balloons intra-operatively. Placement of IAOB is time consuming, resource intensive with a risk of thromboembolism in upto 15% of patients fetal exposure to radiation [9]. The acceptance and use of these techniques is increasing despite lack of convincing evidence that this practise reliably results in improved clinical outcomes [9,10].

A 2012 review of the literature regarding use of IAOB and arterial embolisation in cases of planned surgery for morbidly adherent placenta revealed 20 relevant reports with no randomized-controlled trials, and a total of 132 patients. The review revealed mixed results, concluding that prophylactic balloon occlusion of the internal iliac arteries is still a controversial procedure without a clearly demonstrated reduction in estimated blood loss, operative time, or hospital stay [9].

We did not have any complications in our study secondary to IAOB. However, uterine artery embolization is associated with a complication rate of 9%-13% with complications such as post-embolization syndrome, uterine or vaginal necrosis and sepsis, uterine artery dissection, paraesthesia, and acute ischemia of the lower limbs [11-18].

RESULTSWe analysed estimated blood loss as our primary outcome

in our prospective group. Secondary outcomes operative time, surgical complications, balloon catheter-related complications, length of stay, and neonatal outcome. Study data were entered into an Excel database, and then imported into SAS version 9.4 (SAS Institute Inc. Cary NC) for final analysis. All statistical tests were two-sided at a 5% significance level. Demographic and clinical characteristics of all patients were summarized by cohorts. Continuous variables were presented as mean, standard deviation, median and range. Categorical variables were presented as frequencies and percentages. For those measured on both cohorts, statistical difference was assessed using the Fisher’s exact test on categorical variables, and two sample t-test on continuous variables. In the retrospective data we looked at the average blood loss with caesarean hysterectomies and abnormal placentation confirmed on histology. This was our control group.

Due to the small sample sizes, non-parametric Wilcoxon test was used on continuous variables if the data were not normally distributed. Both unadjusted and adjusted regression analysis were conducted on the primary outcome (blood loss), taking into account the number of previous caesarean section. One prospective patient was identified as an outlier and excluded from regression analysis. Model-estimated difference between the means was tested, with associated 95% confidence interval and p-value. No imputation was considered on the missing data (Table 1 and Table 2).

Figure 1 MRI of Placenta Accreta.

Figure 2 Internal Iliac artery ligation.

Figure 3 MRI evidence of massive collateral blood supply with abnormal placentation.

DISCUSSIONOur study demonstrated that there was significant

decrease in blood loss with balloon placement compared to the retrospective data from Auckland City Hospital. However, we do need to take into account that a multidisciplinary team, access to other surgical specialities and a military like approach with clear documentation of management plan in the clinical notes was also established at the same time as the study.

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Table 1: Table demonstrating Unadjusted Regression Analysis.

Estimated blood loss (mls)Unadjusted Regression Analysis#

Mean S.E P-value 95% Lower C.I. 95% Upper C.I. Treatment Groups* Prospective 3123.08 983.41 0.0031 1128.62 5117.53 Retrospective 6680.00 709.15 <.0001 5241.78 8118.22Prospective vs Retrospective -3556.92 1212.43 0.0058 -6015.87 -1097.97

Table 2: Demonstrating Adjusted Regression Analysis.

Estimated blood loss (mls)Adjusted Regression Analysis*Mean S.E P-value 95% Lower C.I. 95% Upper C.I.

Treatment Groups* Prospective 3700.33 973.66 0.0006 1723.69 5676.97 Retrospective 6379.83 689.39 <.0001 4980.29 7779.36Prospective vs Retrospective -2679.49 1223.55 0.0353 -5163.46 -195.53Covariates* Previous caesarean -848.70 391.65 0.0371

The results might also be a result of a multidisciplinary approach to abnormal placentation and clear communication between at all medical personnel involved in the care of the patient. Patient care should be individualised, managements plans clearly documented in the acute and elective setting. This makes for decreased blood loss and decreased morbidity/mortality along with the medical device - internal iliac balloon catheters.

ACKNOWLEDGEMENTSOur thanks go to Yannan Jiang PhD, for statistical advice.

REFERENCES1. Read JA, Cotton DB, Miller FC. Placenta Accreta: Changing clinical

aspects and outcome. Obstet Gynecol. 1980; 56: 31-34.

2. Wu S, Kocherginsky M, Hibbard JU. Abnormal placentation: twenty-year analysis. Am J Obstet Gynecol. 2005; 192: 1458-1461.

3. Dwyer BK, Belogolovkin V, Tran L, Rao A, Carroll I, Barth R, et al. Prenatal diagnosis of placenta accreta: sonography or magnetic resonance imaging? J Ultrasound Med. 2008; 27: 1275-1281.

4. Comstock CH. Antenatal diagnosis of placenta accreta: a review. Ultrasound Obstet Gynecol. 2005; 26: 89-96.

5. Placenta accreta. Statement from the Royal Australian and New Zealand College of Obstetricians and Gynaecologists. C-Obs 20. 2014.

6. Committee opinion Number 529: Placenta Accreta. The American College Obstet Gyn. 2012.

7. Stotler B, Padmanabhan A, Devine P, Wright J, Spiualnik SL, Schwartz J. Transfusion requirements in obstetric patient with placenta accreta. Transfusion. 2011; 51: 2627-2633.

8. Warshak CR, Ramos GA, Eskander R, Benirschke K, Sanez CC, Kelly TF, et al. Effect of predelivery diagnosis in 99 consecutive cases of placenta accreta. Obstet Gyn. 2010; 115: 65-69.

9. 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: 515-520.

10. Allen R, Robson S, Tamhane R. The very many uses of IR. RANZCOG O&G Magazine. 2015; 17: 38-41.

11. Greenberg JI, Suliman A, Iranpour P, Angle N. Prophylactic balloon occlusion of the internal iliac arteries to treat abnormal placentation: a cautionary case. Am J Obstet Gynecol. 2007; 197: 1-4.

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: 1158-1163.

13. 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: 354-361.

14. Stroud TH, Sandhu J, Mauro MA, Jaques PF, Weeks SM. Temporary balloon occlusion in the internal iliac arteries for control of hemorrhage during cesarean hysterectomy in a patient with placenta previa and placenta increta. J Vasc Interv Radiol. 2000; 11: 622-624.

15. Clausen C, Stensballe J, Albrechtsen CK, Hansen MA, Lönn L, Langhoff-Roos J. Balloon occlusion of the internal iliac arteries in the multidisciplinary management of placenta percreta. Acta Obstet Gynecol Scand. 2013; 92: 386-391.

16. Carnevale FC, Kondo MM, de Oliveira Sousa W Jr, 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: 758-764.

17. Thon S, McLintic A, Wagner Y. Prophylactic endovascular placement of internal iliac occlusion balloon catheters in parturients with placenta accreta: a retrospective case series. Int J Obstet Anesth. 2011; 20: 64-70.

18. Izbizky G, Meller C, Grasso M, Velazco A, Peralta O, Orano L, et al. Feasibility and safety of prophylactic uterine artery catheterization and embolization in the management of placent accrete. J vascular intervent radiol. 2015; 26: 162-169.

Chowdary P, Makary M, McDougall J, Buckley B (2017) The Management of Obstetric Haemorrhage with Internal Illiac Balloon Catheters Secondary to Abnormal Placentation: A 5 Year Prospective Cohort Study. Med J Obstet Gynecol 5(4): 1111.

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