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Prophylactic use of intravascular balloon catheters in women with placenta accreta, increta and percreta
European Journal of Obstetrics & Gynecology and Reproductive Biology 179 (2014) 36–41
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European Journal of Obstetrics & Gynecology and Reproductive Biology journal homepage: www.elsevier.com/locate/ejogrb
Prophylactic use of intravascular balloon catheters in women with placenta accreta, increta and percreta Giuseppe Cali a , Francesco Forlani b, *, Laura Giambanco a , Maria Luisa Amico a , Mario Vallone c , Giuseppe Puccio d , Luigi Alio a a
Department of Obstetrics and Gynecology, Arnas Civico, Di Cristina e Benfratelli, Palermo, Italy Department of Obstetrics and Gynecology, University Hospital “Paolo Giaccone”, Alfonso Giordano 3, Palermo 90100, Italy c Operative Unit of Vascular Radiology and Endovascular Therapy, Arnas Civico, Di Cristina e Benfratelli, Palermo, Italy d Operative Unit of Pediatrics and Neonatal Intensive Therapy, University Hospital, Palermo, Italy b
A R T I C L E I N F O
A B S T R A C T
Article history: Received 30 December 2013 Received in revised form 25 April 2014 Accepted 9 May 2014
Objective: To evaluate outcomes of women undergoing cesarean hysterectomy for abnormal invasive placenta (AIP) with and without preoperative balloon catheter placement in internal iliac arteries. Study design: A prospective observational study of women with ultrasound diagnosis of AIP and a planned delivery at our institution. From January 2004 to June 2009, all AIP cases were treated with planned multidisciplinary cesarean hysterectomy alone (CHa group). From July 2009 to September 2013 a preoperative balloon catheter protocol was introduced (BC group). Statistical analysis considered the entire sample (placenta accreta/increta and percreta) and the individual subgroups (accreta/increta vs percreta). Results: Twenty-three cases of AIP (10 accreta/increta and 13 percreta) were treated with cesarean hysterectomy alone, and 30 cases of AIP (12 accreta/increta and 18 percreta) were treated with cesarean hysterectomy and pre-operative balloon catheters. For the entire sample, a significant difference in estimated blood loss and transfused blood products units was observed between CHa group and BC group. When women with placenta accreta/increta and women with placenta percreta were analysed separately, no difference in estimated blood loss and transfused blood products units was found between the BC and the CHa groups in women with placenta accreta/increta. However, in women with placenta percreta, mean estimated blood loss and transfused blood products units were higher in the CHa group compared with BC group (1507 ml vs 933.33 ml; 3.31 units vs 0.67 units). Postoperative recovery differed between the two groups, but no differences were observed in any other outcomes. Conclusions: Pre-operative placement of intravascular balloon catheters is a feasible treatment for AIP, and is particularly useful in cases of placenta percreta. ã 2014 Elsevier Ireland Ltd. All rights reserved.
Keywords: Balloon catheters Placenta accreta Cesarean hysterectomy
Introduction The three forms of abnormal invasive placenta (AIP) (accreta, increta and percreta) are an emerging obstetrical pathology. Over the last 50 years, the incidence of AIP has increased 10 fold with a reported rate of one case every 2500 deliveries [1]. Recent data indicate an incidence of one case per 533 pregnancies [2]. The increased incidence of AIP correlates with the increased rate of cesarean section deliveries [3], which represents the main risk factor. It is a well known that the area of abnormal placental invasion coincides with the previous uterine scar, and that the risk
* Corresponding author. Tel.: +39 916552004/3402559389; fax: +39 916552007. E-mail address: [email protected] (F. Forlani). http://dx.doi.org/10.1016/j.ejogrb.2014.05.007 0301-2115/ ã 2014 Elsevier Ireland Ltd. All rights reserved.
of AIP increases in direct correlation with the number of previous cesarean sections, especially when there is co-existing placenta previa [4]. Other risk factors include advanced maternal age, multiparity, myometrial damage secondary to myomectomy, endometrial defects due to vigorous curettage resulting in Asherman's syndrome [5], submucous leiomyomas, [4] thermal ablation [6], and previous uterine artery embolization [7]. AIP increases the likelihood of significant maternal/neonatal morbidity and mortality, especially if diagnosed at delivery. Attempts to remove the placenta can cause severe life-threatening bleeding. Prenatal diagnosis of AIP using ultrasound and/or magnetic resonance imaging in high-risk populations is feasible, and can improve both maternal and neonatal outcomes via a delivery planning process led by an experienced obstetric team including anesthesiologists, senior gynecologists, neonatologists,
G. Cali et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 2 179 (2014) 36–41
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Fig. 1. (A) Normal placenta; (B) placenta accreta: adherence of placenta directly to the superficial myometrium; (C) placenta increta: villi invade into the myometrium; (D) placenta percreta: villi invade through the full thickness of myometrium to the serosa and bladder.
urologists and interventional radiologists [8,9]. The American College of Obstetricians and Gynecologists recommend planned preterm (34 weeks of gestation) cesarean hysterectomy without placental disruption in cases of AIP, although a conservative treatment may be applied for women with a strong desire to retain their fertility [10]. In recent years, one of the most debated topics has been the use pre-operative intravascular balloon catheters for temporary occlusion of internal iliac arteries in women with prenatal diagnosis of AIP. Published data include various case reports and small series with variable results ranging from beneficial to uncertain to no benefit [11]. At present, balloon catheter placement remains controversial as no randomized controlled trials have been undertaken [12,13]. The aim of this prospective observational study was to evaluate the outcomes of women undergoing cesarean hysterectomy for different types of AIP with and without pre-operative intravascular balloon catheter placement.
routinely before delivery, if not previously. Women were given comprehensive information on the severity of their clinical condition, treatment options, and related risks and all women gave their written consent to participate in the study. From January 2004 to June 2009, due to unavailability of an interventional radiology service, all AIP cases were treated with cesarean hysterectomy alone (CHa group) using a
Methods All women with an ultrasound diagnosis of AIP and a planned delivery at the study institution were enrolled prospectively at the regional referral centre for AIP. Ultrasound diagnosis was made using two-dimensional gray-scale and colour Doppler, and threedimensional power Doppler sonographic criteria [14]. Following diagnosis, all patients underwent individualized clinical and ultrasound monitoring of their pregnancy based on the severity of the sonographic image and gestational age. The planned date of delivery was decided on a case-by-case basis based on contractile activity, severe uterine bleeding, pre-eclampsia, multiple pregnancy, ultrasound image of bladder infiltration, following multidisciplinary counselling. Antenatal corticosteroids were administered
Fig. 2. Diagram of the pelvic vascularization to show the point where the balloon is positioned.
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G. Cali et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 2 179 (2014) 36–41
Table 1 Demographic characteristics, prenatal and final pathology diagnosis for all patients who received cesarean hysterectomy with and without preoperative intravascular balloon catheters. Balloon catheters and hysterectomy (n = 30)
Maternal age (years) GA at delivery (days)
Hysterctomy without balloon catheters (n = 23)
p-value
Mean
SD
Median
Range
Mean
SD
Median
Range
34.27 243.66
4.50 11.36
34 247
27–46 221–259
33.87 240.60
3.97 19.66
35 246
27–40 236–271
0.88 0.67
3 >3 3 >3 1 2 3 Accreta/increta Percreta Accreta/increta Percreta
Gravidity Parity Previous CS
Prenatal diagnosis Pathological diagnosis
No. of cases
%
No. of cases
%
p-value
17 13 28 2 9 13 8 13 17 12 8
56.7 46.3 93.3 6.7 30 43.3 26.7 43.3 56.7 40.0 60.0
14 9 20 3 7 10 6 10 13 10 13
60.9 39.1 87.0 13.0 30.4 43.5 26 43.5 56.5 43.5 56.5
0.76
multidisciplinary approach (i.e. senior gynaecologist, anaesthesiology and neonatology teams, urologist for inserting ureteral stents in the presence of ultrasound signs of bladder infiltration, adequate number of blood units in the operating room). From July 2009, due to the availability of an interventional radiology service, a new protocol was adopted and all cases of AIP were treated with d cesarean hysterectomy and pre-operative temporary occlusion of internal iliac arteries with balloon catheters (BC group). The multidisciplinary team remained the same throughout the study. For both groups, the laparotomy was performed through a midline incision from the mons pubis to above the umbilicus. The uterine incision was longitudinal on the fundus, avoiding the lower uterine segment to prevent excessive bleeding. In the CHa group, following fetus delivery and cord clamping, an attempt was made to detach the placenta by administration of carbetocin and application of controlled cord traction. No attempt was made to expel or manually remove the placenta when it was evident that it had reached the uterine serosa (Fig. 1D). In the event of failed placental detachment, a hysterectomy was performed, preserving the adnexa and leaving the placenta in situ. In the BC group, the patient was escorted to the angiography suite by the multidisciplinary team on the day of surgery. Following epidural anesthesia and inserting the ureteral stents (when placenta percreta was sonographically suspected), the radiological time was started. Percutaneous catheterization of the common femoral arteries according to Saldinger was performed, and a 4 Fr introducer (Fortress-Biotronik) was positioned in the proximity of the hypogastric artery ostium. Using 4 Fr angiographic catheters (Cobra), the hypogastric arteries were catheterized unilaterally and a V-14 guidewire was inserted (Boston Scientific) with the
0.43 0.99
0.99 0.24
distal end placed in the rear branch of the internal iliac arteries to avoid spasms and/or dissections of the uterine arteries. Following insertion of the angiographic guidewire, a Monorail balloon catheter, of adequate (size based on diameter and length of the hypogastric artery trunk) was inserted (Fig. 2). The angiographic manoeuvres and appropriate balloon positioning was verified by angiographic control, with 1 frame/s images and maximum distance from X-ray source, avoiding image magnification. Balloon catheters were taped to the skin temporarily using gauzes and sterile adhesive drapes. Following fetus delivery and cord clamping, the balloon catheters were activated in cases of failed placental detachment (as described above), and a hysterectomy was performed, preserving the adnexa and leaving the placenta in situ. The balloon was deflated intra-operatively to verify the hemostasis after uterus removal. Endovascular catheters were removed permanently at the end of the procedure following radioscopic verification of appropriate hemostasis. The haemostasis at the percutaneous catheterization sites was performed using arterial closure devices. Prenatal diagnosis of AIP was confirmed during caesarean section delivery with failed placental detachment and by pathological examination of the removed uterus. Three women had conservative treatment (i.e. did not have hysterectomy), and were excluded from the study. The following outcomes were considered: estimated blood loss; transfused blood products units; operative time; Apgar score at 1 and 5 min; postoperative recovery; and intensive care unit admissions. Estimated blood loss was quantified using the volume of suction containers, weight of swabs and visual estimation of vaginal blood loss. Surgical complications, balloon catheter-related complications, and fluoroscopy times were also reported. To
Table 2 Outcomes in patients with placenta accreta/increta and percreta. Balloon catheters and hysterectomy (n = 30)
EBL BPu OT POd Apgar 10 Apgar 50
Hysterectomy without balloon catheters (n = 23)
p-value
Mean
SD
Median
Range
Mean
SD
Median
Range
846.67 0.47 168.8 6.8 7.9 8.8
280.06 0.86 38.4 2.5 0.65 0.41
800 0 175 6.0 8 9
400–1700 0–2 105–240 5–19 7–9 8–9
1156.52 1.96 173.9 7.2 7.4 8.65
576.69 2.46 41.2 1.6 1.27 0.98
1200 2 180 7 8 9
400–2800 0–8 110–250 5–12 3–9 6–10
0.036 0.011 0.65 0.09 0.20 0.99
EBL: estimated blood loss measured in millilitres; BPu: blood products unit transfused; OT: operative time in minutes; POd: postoperative days; Apgar index at first and fifth minute.
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Table 3 Outcomes in patients with placenta accreta/increta. Balloon catheters and hysterectomy (n = 12)
EBL BPu OT POd Apgar 10 Apgar 50
Hysterectomy without balloon catheters (n = 23)
p-value
Mean
SD
Median
Range
Mean
SD
Median
Range
716.67 0.17 160.4 6.58 7.9 9
340.68 0.58 42.9 1.2 0.67 0.00
650 0 155 6.0 8 9
400–1700 0–2 105–240 5–9 7–9 9–9
700 0.20 161.0 6.70 7.9 9
266.67 0.63 43.1 1.6 0.64 0.67
700 0 160 6.5 8 9
400–1200 0–2 110–240 5–10 7–9 8–10
0.92 0.95 0.95 1 0.97 1
EBL: estimated blood loss measured in millilitres; BPu: blood products units transfused; OT: operative time in minutes; POd: postoperative days; Apgar index at first and fifth minute.
evaluate outcomes with and without pre-operative intravascular balloon catheters, statistical analysis considered the entire sample (i.e. cases of placenta accreta/increta and placenta percreta) and the individual subgroups (placenta accreta/increta vs placenta percreta). Statistical analysis was performed using the Mann–Whitney U-test and epiR Version 0.9–32 (Foundation for Statistical Computing, Vienna, Austria). Results From January 2004 to September 2013, 53 women with a prenatal ultrasound diagnosis of AIP and a planned cesarean hysterectomy were enrolled prospectively. From January 2004 to June 2009, 23 cases of AIP (10 accreta/increta and 13 percreta) were treated with caesarean hysterectomy alone (CHa group). From July 2009 to September 2013, 30 cases of AIP (12 accreta/increta and 18 percreta) were treated with caesarean hysterectomy and preoperative balloon catheters (BC group). All women had an anterior placenta previa overlying the scar of previous cesarean section. No significant differences were detected between the two groups in terms of maternal demographics (Table 1). Prenatal diagnoses of placenta accreta/increta (n = 23) and percreta (n = 30) were confirmed by histological examination of the removed uterus in all cases except one (22 placenta accreta/increta and 31 placenta percreta). The BC group included three patients with multiple pregnancy (two dichorionic/diamniotic with one of the two placentas percreta, and one trichorionic/triamniotic with one of the three placentas percreta), and two patients who developed severe pre-eclampsia (one with placenta accreta, one with placenta percreta). All women included in the study initially received an epidural anesthesia, and it was converted to general anesthesia in the event of excessive bleeding (BC group: in one case of placenta accreta and in five cases of placenta percreta; CHa group: in three cases of placenta accreta and 12 cases of placenta percreta). Considering all women with a confirmed diagnosis of placenta accreta/increta or placenta percreta treated with or without
balloon catheters, a significant difference in estimated blood loss and transfused blood products units was observed between the Cha and BC groups (Table 2). Interestingly, different results were obtained when women with placenta accreta/increta and women with placenta percreta treated with and without balloon catheters were assessed separately. No difference in estimated blood loss and transfused blood products units was detected between the BC and the CHa group in women with placenta accreta/increta (Table 3) but a significant difference was found in women with placenta percreta (Table 4). In case of placenta percreta, mean estimated blood loss was 933.33 ml in the BC group and 1507.69 ml in the CHa group (p = 0.13). Consequently, women with placenta percreta had greater need for transfused blood products units and longer postoperative recovery, and this differed significantly between the BC and CHa groups (p = 0.0008 and p = 0.019). No significant differences in operative time and Apgar scores were found between the BC group and CHa groups. No women in either group required an intensive care unit admission. In terms of surgical complications, three accidental bladder lesions were reported (one in the BC group and two in the CHa group) in women with placenta accreta/increta. In women with placenta percreta three intentional cystotomies were reported in the BC group (one of which with a residual vesico-vaginal fistula that resolved spontaneously), and one accidental bladder lesion and one ureteral injury in the CHa group (Table 5). All lesions were repaired during the surgical procedure. No case required surgical re-intervention, and no complications were related to the use of endovascular catheters. The median fluoroscopy exposure time was 3.1 min (range: 2.1–4.6 min). Comment A prenatal diagnosis of AIP enables the multidisciplinary team to plan the delivery, thus reducing maternal/fetal morbidity and mortality [10]. Current management strategies for abnormal placentation include caesarean hysterectomy or conservative techniques without hysterectomy, leaving the placenta in situ. Despite the successful outcomes of these techniques, there is an
Table 4 Outcomes in patients with placenta percreta. Balloon catheters and hysterectomy (n = 18)
EBL BPu OT POd Apgar 10 Apgar 50
Hysterectomy without balloon catheters (n = 13)
p-value
Mean
SD
Median
Range
Mean
SD
Median
Range
933.33 0.67 174.4 7.0 7.8 8.6
197.03 0.97 35.3 3.1 0.65 0.50
1000 0 180 6 8 9
600–1200 0–2 110–240 5–19 7–9 8–9
1507.69 3.31 183.8 7.6 7.0 8.4
499.10 2.50 38.4 1.6 1.47 1.12
1500 2 180 7 7 9
800–2800 0–8 110–250 6–12 3–8 6–9
0.00013 0.0008 0.56 0.019 0.10 0.98
EBL: estimated blood loss measured in millilitres; BPu: blood products units transfused; OT: operative time in minutes; POd: postoperative days; Apgar index at first and fifth minute.
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G. Cali et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 2 179 (2014) 36–41
Table 5 Surgical complications among patients who received cesarean hysterectomy with and without preoperative intravascular balloon catheters. Balloon catheters and hysterectomy (n = 30)
Accreta/increta Percreta Total a
Hysterectomy without balloon catheters (n = 23)
p-value
Yes
%
No
%
Yes
%
No
%
1 4a 5
83 22.2 16.7
11 14 25
91.7 77.8 83.3
2 2 4
20.0 15.4 17.4
8 11 19
80.0 84.6 82.6
0.43 0.63 0.94
Including three intentional cystotomies.
associated risk of sepsis, delayed haemorrhage and/or additional treatment [15,16]. The benefits of interventional radiology with pre-operative internal iliac artery balloon catheters remain a subject of debate, and the lack of randomized controlled trials makes it difficult to reach definitive agreement on this topic. Data in literature indicate a lack of benefit and potential complications related to the radiology procedure; however such data mainly derive from case reports and small case series [15,17]. In a case control study, Shrivastava et al. [12] observed no improvement in the outcomes of women treated with pre-operative balloon catheters plus hysterectomy, compared with the outcomes of women treated with hysterectomy alone. Also, this case control study reported three cases of complications related to the use of the balloon catheter (15.8% of all cases treated with a balloon catheter). On the other hand, increasing data highlight the positive role of interventional radiology in the surgical management of AIP. Tan et al. and Carnevale et al. concluded that pre-operative balloon catheters in internal iliac arteries reduce uterus vascularization, intra-operative blood loss and transfusions [18,19]. In a large retrospective case–control study on 117 patients with placenta accreta (59 with preoperative balloon placement and 58 without balloon placement), Ballas et al. [13] observed greater estimated blood loss and greater need for blood transfusion in the group without balloon. Only two women (3.3%) reported complications due to the use of balloon catheters. In recent years, there has been considerable progress in prenatal diagnosis of AIP. Several studies have demonstrated the possibility of differentiation between serious forms of placenta percreta and less severe forms of placenta accreta/increta using ultrasound [14,20,21]. To the authors knowledge, no previous studies have compared the role of the balloon catheters in women with in placenta accreta/increta vs women with placenta percreta. As such, this prospective study assessed the role of balloon catheters, analysing outcomes for the entire sample and then analysing the results separately for women with placenta accreta/increta and women with placenta percreta. For cases of placenta percreta, women in the BC group had lower estimated blood loss, transfusion of fewer blood product units faster postoperative recovery compared with women in the CHa group. However, no significant differences were detected between the BC and CHa groups for women with placenta accreta/increta. Also, when assessing the entire sample (women with placenta accreta/increta and placenta percreta), significant differences were found between the BC and CHa groups for some of the outcomes. However, this result should only be ascribed to women with placenta percreta, as highlighted by the subsequent sample stratification. In the authors' opinion, the diversification by degree of AIP (placenta accreta/increta vs placenta percreta), not considered previously in the literature, constitutes one of the strengths of this study. This is characterized by a considerable degree of homogeneity: the same multidisciplinary team followed all the cases under consideration, and enforced the same intraoperative protocol and radiology procedure, thus reducing potential operator-dependent bias. Moreover, the same pathologist examined all samples. However, the lack of randomization and the small sample size represent limitations of this study.
Uterine artery embolization, with or without balloon occlusion, has been described by various authors with different results [22–24]. Angstmann et al. [25] reported significantly less blood loss and transfusion rates in eight women treated with embolization hysterectomy compared with a heterogenous group of 20 nonembolized cases. Bodner et al. [26] found no difference in estimated blood loss, blood products transfusion, operative time and postoperative recovery in six women treated with prophylactic temporary balloon occlusion and embolization followed by cesarean hysterectomy when compared with 22 women who received hysterectomy alone. Recently Poujade et al. [27] discussed the etiopathogenesis, clinical and therapeutic aspects of uterine necrosis following pelvic arterial embolization. It could be maintained that extensive collateral circulation to the placenta percreta uterus limits the hemostatic effect of balloon occlusion, embolization and arterial ligation [28]. Also, the presence of collateral circulation could explain the discrepancy in the results obtained using balloon catheters, depending on whether the balloon is inflated after clamping the cord or intraoperatively in the event of profuse bleeding [13]. The present author believe that in cases of placenta percreta, inflating the balloon after clamping the cord followed by a rapid dissection of the uterine vasculature and hysterectomy, without hesitating to treat hemostasis of blood reflux, is crucial to reduce blood loss. After rapid hysterectomy, opening the collateral circulation leads to bleeding in the pelvic cavity that can be controlled easily with or without selective embolization. Randomized controlled trials are required to draw final conclusion on the benefits of interventional radiology, but the present authors believe that: (a) the use of balloon catheters is safe when performed by an
experienced interventional radiology team; (b) balloon catheters should always be used when prenatal
diagnosis does not allow accurate differentiation between cases of placenta accreta and cases of placenta percreta; (c) interventional radiology should always be used in cases of placenta accreta or percreta for women requiring conservative treatment without hysterectomy who wish to preserve their fertility, and in cases of placenta percreta when performing a hysterectomy would be very demanding due to placental invasion; (d) interventional radiology could be avoided when prenatal diagnosis excludes placenta percreta with a high level of accuracy.
Conflict of interest None. Acknowledgments We acknowledge the contributions of: Roberto Buonasorte, Arnas Civico, Di Cristina e Benfratelli, Unit of Anesthesia and Intensive Care, Palermo, Italia; Gianfranco Fundarñ, Arnas Civico, Di Cristina e Benfratelli, Unit of Anesthesia and Intensive Care,
G. Cali et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 2 179 (2014) 36–41
Palermo, Italia; Giuseppina Orlando, Arnas Civico, Di Cristina e Benfratelli, Department of Obstetrics and Gynecology, Palermo, Italy. References [1] Miller DA, Chollet JA, Goodwin TM. Clinical risk factors for placenta previaplacenta accreta. Am J Obstet Gynecol 1997;177:210–4. [2] Wu S, Kocherginsky M, Hibbard JU. Abnormal placentation: twenty-year analysis. Am J Obstet Gynecol 2005;192:1458–61. [3] Higgins MF, Monteith C, Foley M, O’Herlihy C. Real increasing incidence of hysterectomy for placenta accreta following previous caesarean section. Eur J Obstet Gynecol Reprod Biol 2013;171(1):54–6. [4] Silver RM, Landon MB, Rouse DJ, et al. Maternal morbidity associated with multiple repeat cesarean deliveries. Obstet Gynecol 2006;107(6):1226–32. [5] Al-Serehi A, Mhoyan A, Brown M, Benirschke K, Hull A, Pretorius DH. Placenta accreta: an association with fibroids and Asherman syndrome. J Ultrasound Med 2008;27:1623–8. [6] Hamar BD, Wolff EF, Kodaman PH, Marcovici I. Premature rupture of membranes, placenta increta, and hysterectomy in a pregnancy following endometrial ablation. J Perinatol 2006;26:135–7. [7] Pron G, Mocarski E, Bennett J, Vilos G, Common A, Vanderburgh L, et al. Pregnancy after uterine artery embolization for leiomyomata: the Ontario multicenter trial. Obstet Gynecol 2005;105:67–76. [8] Warshak CR, Ramos GA, Eskander R, et al. Effect of predelivery diagnosis in 99 consecutive cases of placenta accreta. Obstet Gynecol 2010;115:65–9. [9] Eller AG, Porter TF, Soisson P, Silver RM. Optimal management strategies for placenta accreta. BJOG 2009;116:648–54. [10] Placenta accreta. Committee opinion no. 529. American College of Obstetricians and Gynecologists. Obstet Gynecol 2012;120:207–211. [11] Royal College of Obstetricians and Gynaecologists. Placenta praevia, placenta praevia accreta and vasa praevia: diagnosis and management. Green-top guideline no. 27. London, UK: RCOG; 2011. [12] Shrivastava V, Nageotte M, Major C, Haydon M, Wing D. Case-control comparison of cesarean hysterectomy with and without prophylactic placement of intravascular balloon catheters for placenta accreta. Am J Obstet Gynecol 2007;197(402):e1–5. [13] Ballas J, Hull AD, Saenz C, et al. Preoperative intravascular balloon catheters and surgical outcomes in pregnancies complicated by placenta accreta: a management paradox. Am J Obstet Gynecol 2012;207(3):216.e1–5. [14] Calì G, Giambanco L, Puccio G, Forlani F. Morbidly adherent placenta: evaluation of ultrasound diagnostic criteria and differentiation of placenta accreta from percreta. Ultrasound Obstet Gynecol 2013;41(4):406–12.
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European Journal of Obstetrics & Gynecology and Reproductive Biology journal homepage: www.elsevier.com/locate/ejogrb
Prophylactic use of intravascular balloon catheters in women with placenta accreta, increta and percreta Giuseppe Cali a , Francesco Forlani b, *, Laura Giambanco a , Maria Luisa Amico a , Mario Vallone c , Giuseppe Puccio d , Luigi Alio a a
Department of Obstetrics and Gynecology, Arnas Civico, Di Cristina e Benfratelli, Palermo, Italy Department of Obstetrics and Gynecology, University Hospital “Paolo Giaccone”, Alfonso Giordano 3, Palermo 90100, Italy c Operative Unit of Vascular Radiology and Endovascular Therapy, Arnas Civico, Di Cristina e Benfratelli, Palermo, Italy d Operative Unit of Pediatrics and Neonatal Intensive Therapy, University Hospital, Palermo, Italy b
A R T I C L E I N F O
A B S T R A C T
Article history: Received 30 December 2013 Received in revised form 25 April 2014 Accepted 9 May 2014
Objective: To evaluate outcomes of women undergoing cesarean hysterectomy for abnormal invasive placenta (AIP) with and without preoperative balloon catheter placement in internal iliac arteries. Study design: A prospective observational study of women with ultrasound diagnosis of AIP and a planned delivery at our institution. From January 2004 to June 2009, all AIP cases were treated with planned multidisciplinary cesarean hysterectomy alone (CHa group). From July 2009 to September 2013 a preoperative balloon catheter protocol was introduced (BC group). Statistical analysis considered the entire sample (placenta accreta/increta and percreta) and the individual subgroups (accreta/increta vs percreta). Results: Twenty-three cases of AIP (10 accreta/increta and 13 percreta) were treated with cesarean hysterectomy alone, and 30 cases of AIP (12 accreta/increta and 18 percreta) were treated with cesarean hysterectomy and pre-operative balloon catheters. For the entire sample, a significant difference in estimated blood loss and transfused blood products units was observed between CHa group and BC group. When women with placenta accreta/increta and women with placenta percreta were analysed separately, no difference in estimated blood loss and transfused blood products units was found between the BC and the CHa groups in women with placenta accreta/increta. However, in women with placenta percreta, mean estimated blood loss and transfused blood products units were higher in the CHa group compared with BC group (1507 ml vs 933.33 ml; 3.31 units vs 0.67 units). Postoperative recovery differed between the two groups, but no differences were observed in any other outcomes. Conclusions: Pre-operative placement of intravascular balloon catheters is a feasible treatment for AIP, and is particularly useful in cases of placenta percreta. ã 2014 Elsevier Ireland Ltd. All rights reserved.
Keywords: Balloon catheters Placenta accreta Cesarean hysterectomy
Introduction The three forms of abnormal invasive placenta (AIP) (accreta, increta and percreta) are an emerging obstetrical pathology. Over the last 50 years, the incidence of AIP has increased 10 fold with a reported rate of one case every 2500 deliveries [1]. Recent data indicate an incidence of one case per 533 pregnancies [2]. The increased incidence of AIP correlates with the increased rate of cesarean section deliveries [3], which represents the main risk factor. It is a well known that the area of abnormal placental invasion coincides with the previous uterine scar, and that the risk
* Corresponding author. Tel.: +39 916552004/3402559389; fax: +39 916552007. E-mail address: [email protected] (F. Forlani). http://dx.doi.org/10.1016/j.ejogrb.2014.05.007 0301-2115/ ã 2014 Elsevier Ireland Ltd. All rights reserved.
of AIP increases in direct correlation with the number of previous cesarean sections, especially when there is co-existing placenta previa [4]. Other risk factors include advanced maternal age, multiparity, myometrial damage secondary to myomectomy, endometrial defects due to vigorous curettage resulting in Asherman's syndrome [5], submucous leiomyomas, [4] thermal ablation [6], and previous uterine artery embolization [7]. AIP increases the likelihood of significant maternal/neonatal morbidity and mortality, especially if diagnosed at delivery. Attempts to remove the placenta can cause severe life-threatening bleeding. Prenatal diagnosis of AIP using ultrasound and/or magnetic resonance imaging in high-risk populations is feasible, and can improve both maternal and neonatal outcomes via a delivery planning process led by an experienced obstetric team including anesthesiologists, senior gynecologists, neonatologists,
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Fig. 1. (A) Normal placenta; (B) placenta accreta: adherence of placenta directly to the superficial myometrium; (C) placenta increta: villi invade into the myometrium; (D) placenta percreta: villi invade through the full thickness of myometrium to the serosa and bladder.
urologists and interventional radiologists [8,9]. The American College of Obstetricians and Gynecologists recommend planned preterm (34 weeks of gestation) cesarean hysterectomy without placental disruption in cases of AIP, although a conservative treatment may be applied for women with a strong desire to retain their fertility [10]. In recent years, one of the most debated topics has been the use pre-operative intravascular balloon catheters for temporary occlusion of internal iliac arteries in women with prenatal diagnosis of AIP. Published data include various case reports and small series with variable results ranging from beneficial to uncertain to no benefit [11]. At present, balloon catheter placement remains controversial as no randomized controlled trials have been undertaken [12,13]. The aim of this prospective observational study was to evaluate the outcomes of women undergoing cesarean hysterectomy for different types of AIP with and without pre-operative intravascular balloon catheter placement.
routinely before delivery, if not previously. Women were given comprehensive information on the severity of their clinical condition, treatment options, and related risks and all women gave their written consent to participate in the study. From January 2004 to June 2009, due to unavailability of an interventional radiology service, all AIP cases were treated with cesarean hysterectomy alone (CHa group) using a
Methods All women with an ultrasound diagnosis of AIP and a planned delivery at the study institution were enrolled prospectively at the regional referral centre for AIP. Ultrasound diagnosis was made using two-dimensional gray-scale and colour Doppler, and threedimensional power Doppler sonographic criteria [14]. Following diagnosis, all patients underwent individualized clinical and ultrasound monitoring of their pregnancy based on the severity of the sonographic image and gestational age. The planned date of delivery was decided on a case-by-case basis based on contractile activity, severe uterine bleeding, pre-eclampsia, multiple pregnancy, ultrasound image of bladder infiltration, following multidisciplinary counselling. Antenatal corticosteroids were administered
Fig. 2. Diagram of the pelvic vascularization to show the point where the balloon is positioned.
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G. Cali et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 2 179 (2014) 36–41
Table 1 Demographic characteristics, prenatal and final pathology diagnosis for all patients who received cesarean hysterectomy with and without preoperative intravascular balloon catheters. Balloon catheters and hysterectomy (n = 30)
Maternal age (years) GA at delivery (days)
Hysterctomy without balloon catheters (n = 23)
p-value
Mean
SD
Median
Range
Mean
SD
Median
Range
34.27 243.66
4.50 11.36
34 247
27–46 221–259
33.87 240.60
3.97 19.66
35 246
27–40 236–271
0.88 0.67
3 >3 3 >3 1 2 3 Accreta/increta Percreta Accreta/increta Percreta
Gravidity Parity Previous CS
Prenatal diagnosis Pathological diagnosis
No. of cases
%
No. of cases
%
p-value
17 13 28 2 9 13 8 13 17 12 8
56.7 46.3 93.3 6.7 30 43.3 26.7 43.3 56.7 40.0 60.0
14 9 20 3 7 10 6 10 13 10 13
60.9 39.1 87.0 13.0 30.4 43.5 26 43.5 56.5 43.5 56.5
0.76
multidisciplinary approach (i.e. senior gynaecologist, anaesthesiology and neonatology teams, urologist for inserting ureteral stents in the presence of ultrasound signs of bladder infiltration, adequate number of blood units in the operating room). From July 2009, due to the availability of an interventional radiology service, a new protocol was adopted and all cases of AIP were treated with d cesarean hysterectomy and pre-operative temporary occlusion of internal iliac arteries with balloon catheters (BC group). The multidisciplinary team remained the same throughout the study. For both groups, the laparotomy was performed through a midline incision from the mons pubis to above the umbilicus. The uterine incision was longitudinal on the fundus, avoiding the lower uterine segment to prevent excessive bleeding. In the CHa group, following fetus delivery and cord clamping, an attempt was made to detach the placenta by administration of carbetocin and application of controlled cord traction. No attempt was made to expel or manually remove the placenta when it was evident that it had reached the uterine serosa (Fig. 1D). In the event of failed placental detachment, a hysterectomy was performed, preserving the adnexa and leaving the placenta in situ. In the BC group, the patient was escorted to the angiography suite by the multidisciplinary team on the day of surgery. Following epidural anesthesia and inserting the ureteral stents (when placenta percreta was sonographically suspected), the radiological time was started. Percutaneous catheterization of the common femoral arteries according to Saldinger was performed, and a 4 Fr introducer (Fortress-Biotronik) was positioned in the proximity of the hypogastric artery ostium. Using 4 Fr angiographic catheters (Cobra), the hypogastric arteries were catheterized unilaterally and a V-14 guidewire was inserted (Boston Scientific) with the
0.43 0.99
0.99 0.24
distal end placed in the rear branch of the internal iliac arteries to avoid spasms and/or dissections of the uterine arteries. Following insertion of the angiographic guidewire, a Monorail balloon catheter, of adequate (size based on diameter and length of the hypogastric artery trunk) was inserted (Fig. 2). The angiographic manoeuvres and appropriate balloon positioning was verified by angiographic control, with 1 frame/s images and maximum distance from X-ray source, avoiding image magnification. Balloon catheters were taped to the skin temporarily using gauzes and sterile adhesive drapes. Following fetus delivery and cord clamping, the balloon catheters were activated in cases of failed placental detachment (as described above), and a hysterectomy was performed, preserving the adnexa and leaving the placenta in situ. The balloon was deflated intra-operatively to verify the hemostasis after uterus removal. Endovascular catheters were removed permanently at the end of the procedure following radioscopic verification of appropriate hemostasis. The haemostasis at the percutaneous catheterization sites was performed using arterial closure devices. Prenatal diagnosis of AIP was confirmed during caesarean section delivery with failed placental detachment and by pathological examination of the removed uterus. Three women had conservative treatment (i.e. did not have hysterectomy), and were excluded from the study. The following outcomes were considered: estimated blood loss; transfused blood products units; operative time; Apgar score at 1 and 5 min; postoperative recovery; and intensive care unit admissions. Estimated blood loss was quantified using the volume of suction containers, weight of swabs and visual estimation of vaginal blood loss. Surgical complications, balloon catheter-related complications, and fluoroscopy times were also reported. To
Table 2 Outcomes in patients with placenta accreta/increta and percreta. Balloon catheters and hysterectomy (n = 30)
EBL BPu OT POd Apgar 10 Apgar 50
Hysterectomy without balloon catheters (n = 23)
p-value
Mean
SD
Median
Range
Mean
SD
Median
Range
846.67 0.47 168.8 6.8 7.9 8.8
280.06 0.86 38.4 2.5 0.65 0.41
800 0 175 6.0 8 9
400–1700 0–2 105–240 5–19 7–9 8–9
1156.52 1.96 173.9 7.2 7.4 8.65
576.69 2.46 41.2 1.6 1.27 0.98
1200 2 180 7 8 9
400–2800 0–8 110–250 5–12 3–9 6–10
0.036 0.011 0.65 0.09 0.20 0.99
EBL: estimated blood loss measured in millilitres; BPu: blood products unit transfused; OT: operative time in minutes; POd: postoperative days; Apgar index at first and fifth minute.
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Table 3 Outcomes in patients with placenta accreta/increta. Balloon catheters and hysterectomy (n = 12)
EBL BPu OT POd Apgar 10 Apgar 50
Hysterectomy without balloon catheters (n = 23)
p-value
Mean
SD
Median
Range
Mean
SD
Median
Range
716.67 0.17 160.4 6.58 7.9 9
340.68 0.58 42.9 1.2 0.67 0.00
650 0 155 6.0 8 9
400–1700 0–2 105–240 5–9 7–9 9–9
700 0.20 161.0 6.70 7.9 9
266.67 0.63 43.1 1.6 0.64 0.67
700 0 160 6.5 8 9
400–1200 0–2 110–240 5–10 7–9 8–10
0.92 0.95 0.95 1 0.97 1
EBL: estimated blood loss measured in millilitres; BPu: blood products units transfused; OT: operative time in minutes; POd: postoperative days; Apgar index at first and fifth minute.
evaluate outcomes with and without pre-operative intravascular balloon catheters, statistical analysis considered the entire sample (i.e. cases of placenta accreta/increta and placenta percreta) and the individual subgroups (placenta accreta/increta vs placenta percreta). Statistical analysis was performed using the Mann–Whitney U-test and epiR Version 0.9–32 (Foundation for Statistical Computing, Vienna, Austria). Results From January 2004 to September 2013, 53 women with a prenatal ultrasound diagnosis of AIP and a planned cesarean hysterectomy were enrolled prospectively. From January 2004 to June 2009, 23 cases of AIP (10 accreta/increta and 13 percreta) were treated with caesarean hysterectomy alone (CHa group). From July 2009 to September 2013, 30 cases of AIP (12 accreta/increta and 18 percreta) were treated with caesarean hysterectomy and preoperative balloon catheters (BC group). All women had an anterior placenta previa overlying the scar of previous cesarean section. No significant differences were detected between the two groups in terms of maternal demographics (Table 1). Prenatal diagnoses of placenta accreta/increta (n = 23) and percreta (n = 30) were confirmed by histological examination of the removed uterus in all cases except one (22 placenta accreta/increta and 31 placenta percreta). The BC group included three patients with multiple pregnancy (two dichorionic/diamniotic with one of the two placentas percreta, and one trichorionic/triamniotic with one of the three placentas percreta), and two patients who developed severe pre-eclampsia (one with placenta accreta, one with placenta percreta). All women included in the study initially received an epidural anesthesia, and it was converted to general anesthesia in the event of excessive bleeding (BC group: in one case of placenta accreta and in five cases of placenta percreta; CHa group: in three cases of placenta accreta and 12 cases of placenta percreta). Considering all women with a confirmed diagnosis of placenta accreta/increta or placenta percreta treated with or without
balloon catheters, a significant difference in estimated blood loss and transfused blood products units was observed between the Cha and BC groups (Table 2). Interestingly, different results were obtained when women with placenta accreta/increta and women with placenta percreta treated with and without balloon catheters were assessed separately. No difference in estimated blood loss and transfused blood products units was detected between the BC and the CHa group in women with placenta accreta/increta (Table 3) but a significant difference was found in women with placenta percreta (Table 4). In case of placenta percreta, mean estimated blood loss was 933.33 ml in the BC group and 1507.69 ml in the CHa group (p = 0.13). Consequently, women with placenta percreta had greater need for transfused blood products units and longer postoperative recovery, and this differed significantly between the BC and CHa groups (p = 0.0008 and p = 0.019). No significant differences in operative time and Apgar scores were found between the BC group and CHa groups. No women in either group required an intensive care unit admission. In terms of surgical complications, three accidental bladder lesions were reported (one in the BC group and two in the CHa group) in women with placenta accreta/increta. In women with placenta percreta three intentional cystotomies were reported in the BC group (one of which with a residual vesico-vaginal fistula that resolved spontaneously), and one accidental bladder lesion and one ureteral injury in the CHa group (Table 5). All lesions were repaired during the surgical procedure. No case required surgical re-intervention, and no complications were related to the use of endovascular catheters. The median fluoroscopy exposure time was 3.1 min (range: 2.1–4.6 min). Comment A prenatal diagnosis of AIP enables the multidisciplinary team to plan the delivery, thus reducing maternal/fetal morbidity and mortality [10]. Current management strategies for abnormal placentation include caesarean hysterectomy or conservative techniques without hysterectomy, leaving the placenta in situ. Despite the successful outcomes of these techniques, there is an
Table 4 Outcomes in patients with placenta percreta. Balloon catheters and hysterectomy (n = 18)
EBL BPu OT POd Apgar 10 Apgar 50
Hysterectomy without balloon catheters (n = 13)
p-value
Mean
SD
Median
Range
Mean
SD
Median
Range
933.33 0.67 174.4 7.0 7.8 8.6
197.03 0.97 35.3 3.1 0.65 0.50
1000 0 180 6 8 9
600–1200 0–2 110–240 5–19 7–9 8–9
1507.69 3.31 183.8 7.6 7.0 8.4
499.10 2.50 38.4 1.6 1.47 1.12
1500 2 180 7 7 9
800–2800 0–8 110–250 6–12 3–8 6–9
0.00013 0.0008 0.56 0.019 0.10 0.98
EBL: estimated blood loss measured in millilitres; BPu: blood products units transfused; OT: operative time in minutes; POd: postoperative days; Apgar index at first and fifth minute.
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Table 5 Surgical complications among patients who received cesarean hysterectomy with and without preoperative intravascular balloon catheters. Balloon catheters and hysterectomy (n = 30)
Accreta/increta Percreta Total a
Hysterectomy without balloon catheters (n = 23)
p-value
Yes
%
No
%
Yes
%
No
%
1 4a 5
83 22.2 16.7
11 14 25
91.7 77.8 83.3
2 2 4
20.0 15.4 17.4
8 11 19
80.0 84.6 82.6
0.43 0.63 0.94
Including three intentional cystotomies.
associated risk of sepsis, delayed haemorrhage and/or additional treatment [15,16]. The benefits of interventional radiology with pre-operative internal iliac artery balloon catheters remain a subject of debate, and the lack of randomized controlled trials makes it difficult to reach definitive agreement on this topic. Data in literature indicate a lack of benefit and potential complications related to the radiology procedure; however such data mainly derive from case reports and small case series [15,17]. In a case control study, Shrivastava et al. [12] observed no improvement in the outcomes of women treated with pre-operative balloon catheters plus hysterectomy, compared with the outcomes of women treated with hysterectomy alone. Also, this case control study reported three cases of complications related to the use of the balloon catheter (15.8% of all cases treated with a balloon catheter). On the other hand, increasing data highlight the positive role of interventional radiology in the surgical management of AIP. Tan et al. and Carnevale et al. concluded that pre-operative balloon catheters in internal iliac arteries reduce uterus vascularization, intra-operative blood loss and transfusions [18,19]. In a large retrospective case–control study on 117 patients with placenta accreta (59 with preoperative balloon placement and 58 without balloon placement), Ballas et al. [13] observed greater estimated blood loss and greater need for blood transfusion in the group without balloon. Only two women (3.3%) reported complications due to the use of balloon catheters. In recent years, there has been considerable progress in prenatal diagnosis of AIP. Several studies have demonstrated the possibility of differentiation between serious forms of placenta percreta and less severe forms of placenta accreta/increta using ultrasound [14,20,21]. To the authors knowledge, no previous studies have compared the role of the balloon catheters in women with in placenta accreta/increta vs women with placenta percreta. As such, this prospective study assessed the role of balloon catheters, analysing outcomes for the entire sample and then analysing the results separately for women with placenta accreta/increta and women with placenta percreta. For cases of placenta percreta, women in the BC group had lower estimated blood loss, transfusion of fewer blood product units faster postoperative recovery compared with women in the CHa group. However, no significant differences were detected between the BC and CHa groups for women with placenta accreta/increta. Also, when assessing the entire sample (women with placenta accreta/increta and placenta percreta), significant differences were found between the BC and CHa groups for some of the outcomes. However, this result should only be ascribed to women with placenta percreta, as highlighted by the subsequent sample stratification. In the authors' opinion, the diversification by degree of AIP (placenta accreta/increta vs placenta percreta), not considered previously in the literature, constitutes one of the strengths of this study. This is characterized by a considerable degree of homogeneity: the same multidisciplinary team followed all the cases under consideration, and enforced the same intraoperative protocol and radiology procedure, thus reducing potential operator-dependent bias. Moreover, the same pathologist examined all samples. However, the lack of randomization and the small sample size represent limitations of this study.
Uterine artery embolization, with or without balloon occlusion, has been described by various authors with different results [22–24]. Angstmann et al. [25] reported significantly less blood loss and transfusion rates in eight women treated with embolization hysterectomy compared with a heterogenous group of 20 nonembolized cases. Bodner et al. [26] found no difference in estimated blood loss, blood products transfusion, operative time and postoperative recovery in six women treated with prophylactic temporary balloon occlusion and embolization followed by cesarean hysterectomy when compared with 22 women who received hysterectomy alone. Recently Poujade et al. [27] discussed the etiopathogenesis, clinical and therapeutic aspects of uterine necrosis following pelvic arterial embolization. It could be maintained that extensive collateral circulation to the placenta percreta uterus limits the hemostatic effect of balloon occlusion, embolization and arterial ligation [28]. Also, the presence of collateral circulation could explain the discrepancy in the results obtained using balloon catheters, depending on whether the balloon is inflated after clamping the cord or intraoperatively in the event of profuse bleeding [13]. The present author believe that in cases of placenta percreta, inflating the balloon after clamping the cord followed by a rapid dissection of the uterine vasculature and hysterectomy, without hesitating to treat hemostasis of blood reflux, is crucial to reduce blood loss. After rapid hysterectomy, opening the collateral circulation leads to bleeding in the pelvic cavity that can be controlled easily with or without selective embolization. Randomized controlled trials are required to draw final conclusion on the benefits of interventional radiology, but the present authors believe that: (a) the use of balloon catheters is safe when performed by an
experienced interventional radiology team; (b) balloon catheters should always be used when prenatal
diagnosis does not allow accurate differentiation between cases of placenta accreta and cases of placenta percreta; (c) interventional radiology should always be used in cases of placenta accreta or percreta for women requiring conservative treatment without hysterectomy who wish to preserve their fertility, and in cases of placenta percreta when performing a hysterectomy would be very demanding due to placental invasion; (d) interventional radiology could be avoided when prenatal diagnosis excludes placenta percreta with a high level of accuracy.
Conflict of interest None. Acknowledgments We acknowledge the contributions of: Roberto Buonasorte, Arnas Civico, Di Cristina e Benfratelli, Unit of Anesthesia and Intensive Care, Palermo, Italia; Gianfranco Fundarñ, Arnas Civico, Di Cristina e Benfratelli, Unit of Anesthesia and Intensive Care,
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