Abstract
Uterine balloon tamponade is the first-line treatment for postpartum hemorrhage (PPH). However, as cases accumulate, the disadvantages of conventional balloons, such as difficulties with insertion, displacement, dislodgement, slipping outside, and occlusion of the drainage tube with blood clots, have become evident. The newly developed Atom uterine hemostatic balloon has a stylet designed as an insertion guide for smooth insertion. The end of the insufflation portion can be housed in the handle tip of the stylet inserted into the other drainage tube to facilitate retrograde insertion of the balloon and prevent damage to the cervical canal during cesarean section. This balloon was designed in the shape of an apple to prevent it from slipping off. A drainage port without projections was used to improve adhesion to the uterine luminal wall.
The Atom balloon was inserted transabdominally during cesarean section in 13 patients, transvaginally after completing cesarean section in two patients, and transvaginally after vaginal delivery in two patients. Use of the new balloon had a hemostatic effect in all cases, including a case with coagulopathy. Neither occlusion of the drainage tube nor dislodgement of the balloon was observed. There were no cases of abnormal placement, displacement, or dislodgement at the time of balloon insertion. No complications, such as cervical laceration during insertion or intrauterine infection, were observed.
Introduction
Uterine balloon tamponade is the first-line treatment for postpartum hemorrhage (PPH), as recommended by the International Federation of Gynecology and Obstetrics (Federation Internationale de Gynecologie et de Obstetrique),1,2) American College of Obstetricians and Gynecologists,3) and Royal College of Obstetricians and Gynecologists.4) Various balloons, including the Bakri balloon, are used to treat PPH.5,6,7) In Japan, the Bakri balloon was officially approved and became available as a medical device in 2013. Since the Japanese Guidelines for Treating Obstetric Critical Hemorrhage8) in 2017 recommended balloon tamponade as a hemostatic procedure that should be performed in the early stages of PPH, this procedure has been widely adopted in Japan.9,10,11)
However, as cases accumulate, the disadvantages of conventional balloons, such as difficulties with insertion, displacement, dislodgement, and occlusion of the drainage tube with blood clots, have become evident.7,12) In addition, when a conventional balloon is retrogradely inserted from the uterine cavity during cesarean section,13,14) the proximal connected components of the balloon, consisting of insufflation and drainage portions, are difficult to pass through the cervical canal, and the cervix may be damaged. To address these issues, we developed a new uterine hemostatic balloon and evaluated its hemostatic effect.
Materials and methods
1) Materials
The Atom uterine hemostatic balloon (Atom Medical Corp.) was developed by seven obstetricians/gynecologists at Juntendo University, the University of Tokyo, and Kyoto University for use in uterine hemostasis by balloon tamponade (Figure 1). The stylet was designed as an insertion guide to allow smooth insertion into either an anteflexed or retroflexed uterus, and can be used when the balloon is retrogradely passed from the uterine cavity through the vagina during cesarean section (Figure 2). Among the proximal connected components of the balloon catheter, the end of the irrigation tube can be housed in the handle tip of the stylet inserted into the other drainage tube. This allows for combining two outlet portions into a single bundle, facilitating retrograde insertion of the balloon and preventing damage to the cervix (Figures 2 and 3).
Although many conventional hemostatic balloons are oval in shape, the Atom balloon has the shape of an apple (Figure 4). A drainage port without projections improves adhesion to the uterine luminal wall and prevents the tip of the drainage port from protruding from the balloon. The shape of the cross-section of the drainage tube is circular to facilitate drainage of blood and blood clots when the balloon touches the uterine wall. A drainage tube with a circular cross-section has the lowest resistance in terms of flow dynamics, and the fluid is drained faster through a circular tube than through a non-circular tube (Figure 2). The Atom balloon is made of silicone and has a maximum inflation volume of 500 ml.
2) Methods
This study included 17 patients who were treated for uterine hemorrhage with the Atom balloon after cesarean section or vaginal delivery at three institutions (Juntendo University Hospital, the University of Tokyo Hospital, and Kyoto University Hospital) between December 1, 2019 and January 31, 2020. Medical records of each patient were retrospectively examined for gestational age, mode of delivery, cause of hemorrhage, direction of balloon insertion, volume of water injected into the balloon, volume of blood loss before balloon insertion, volume of blood transfusion, and duration of balloon placement and effects. The balloon was inserted via the vagina in 4/17 patients and via the uterine cavity during cesarean section in the remaining 13 patients. We also asked operators of the Atom balloon to provide voluntary feedback.
This study was approved by the Clinical Investigation Ethics Committee of Juntendo University Hospital and the University of Tokyo Hospital.
Results
Among the 17 patients with a gestational age of 34–41 weeks at delivery, two delivered their infants via transvaginal delivery and 15 underwent cesarean section (elective cesarean section in eight patients and emergency cesarean section in seven patients). Regarding causes and sites of hemorrhage, 12 patients had hemorrhage caused by placental abruption owing to placenta previa, low-lying placenta, or placenta accreta; four had atonic bleeding; and one had atony with coagulopathy. The Atom balloon was inserted transabdominally during cesarean section in 13 patients, transvaginally after completing cesarean section in two patients, and transvaginally after vaginal delivery in two patients (Table 1).
Table 1. Clinical characteristics and outcomes of cases in which a new Atom hemostatic balloon was used
| Gestational weeks | mode of delivery | indications of C/S | bleeding site/
reasons | way of balloon insertion | infusion volume of balloon (ml) | blood loss (ml) before balloon insertion | blood transfusion (IU) | duration of balloon inflation (hours) | slipping outside, displacement and laceration |
|---|
| 1 | 34 | elective C/S | placenta previa | atony | transabdominal | 100 | ? | | 17 | — |
| 2 | 38 | emergent C/S | NRFS | atony | transabdominal | 200 | ? | | ? | — |
| 3 | 37 | elective C/S | placenta previa | placental site, lower segment | transabdominal | 100 | ? | | ? | — |
| 4 | 41 | emergent C/S | airest of labor CAM | placental site | transabdominal | 150 | 1,850 | RBC 4 | 24 | — |
| 5 | 34 | emergent C/S | placenta previa | placental site | transabdominal | 100 | 2,200 | RBC 4 | 17 | — |
| 6 | 39 | elective C/S | low lying placenta | placental site, lower segment | transabdominal | 80 | 1,030 | autologous blood 2 | 23 | — |
| 7 | 38 | emergent C/S | low lying placenta | placental site | transabdominal | 200 | 930 | | 18 | — |
| 8 | 39 | v | — | placenta accreta | transvaginal | 100 | 1,270 | RBC 4 | 9 | — |
| 9 | 35 | emergent C/S | placenta previa | placental site | transabdominal | 200 | 820 | | 17 | — |
| 10 | 40 | emergent C/S | airest of labor | atony at the ward | transvaginal | 150 | 1,100 (operation)
900 (at the ward) | | 17 | — |
| 11 | 36 | elective C/S | placenta previa | placental site | transabdominal | 100 | 1,080 | autologous blood 2 | ? | — |
| 12 | 37 | elective C/S | placenta previa | placental site | transabdominal | 150 | 2,630 | RBC 4
FFP 4 | 20 | — |
| 13 | 38 | elective C/S | breech | atony
after the operation | transvaginal | 150 | 1,350 | | 18 | — |
| 14 | 36 | v | — | abruptio placenta
IUFD, coagulopathy | transvaginal | 150 | 6,850 | RBC 50
FFP 66
PC 50 | 31 | — |
| 15 | 34 | elective C/S | vasa previa | placental site | transabdominal | 150 | 1,110 | | 23 | — |
| 16 | 35 | emergent C/S | placenta previa | placental site | transabdominal | 150 | 1,520 | | 22 | — |
| 17 | 37 | elective C/S | low lying placenta | placental site | transabdominal | 150 | 1,200 | autologous blood 4 | 24 | — |
The mean volume of water injected to inflate the balloon sufficiently to achieve hemostasis was 140.8 ml (range: 80–200 ml) in patients with a transabdominally inserted balloon, 137.5 ml (range: 100–150 ml) in patients with a transvaginally inserted balloon, and 140.0 ml (range: 80–200 ml) in all patients. The volume of blood loss until balloon hemostasis ranged from 820 to 6,850 ml, and eight patients required blood transfusions. The duration of balloon placement ranged from 9 to 31 hours. Atom balloon insertion had a hemostatic effect in all cases (13 patients with a transabdominally inserted balloon and 4 patients with a transvaginally inserted balloon, including a case with coagulopathy). Neither occlusion of the drainage tube nor dislodgement of the balloon was observed. There were no cases of abnormal placement, displacement, or dislodgement at the time of balloon insertion. No complications, such as cervical laceration during insertion or intrauterine infection, were observed (Table 1).
Thirteen operators reported that the stylet facilitated insertion. The stylet was difficult to remove in two patients. When the Atom balloon was retrogradely inserted from the uterus, it was smoothly inserted without the proximal connected components of the catheter being stuck to the orifice of the uterus in 12 patients, and slight resistance was observed in two patients.
Discussion
Although suicide is the leading cause of death in pregnant and postpartum women (maternal death during pregnancy and delayed maternal death within 1 year after delivery) in Europe, the United States, and other developed countries, a major cause of maternal death is hemorrhage, which is the most common cause in Japan.15) Balloon tamponade is the first-line treatment for PPH, except for uterine rupture and other special conditions. When balloon tamponade fails to achieve hemostasis, treatment needs to be escalated to the next line of treatment, such as open surgical hemostasis or transcatheter arterial embolization (TAE). Performing balloon tamponade first is also important in terms of the balloon tamponade test. Serial monitoring of vital signs and hemorrhage after uterine tamponade are important for its management. Obstetricians should keep in mind that while balloon tamponade is a beneficial option for hemostasis, it is also used as a test to assess the need for further treatment.16) Balloon tamponade is also performed for hemostasis during cesarean section, particularly when treating placenta previa and atonic bleeding or prevention of hemorrhage caused by placental abruption owing to placenta previa and other conditions.12,13,14)
Uterine balloon tamponade is often performed using a dedicated Bakri balloon, as well as a metreurynter, condom, and urinary catheter. However, the procedure is associated with several issues. For example, insertion takes a long time; the balloon can be abnormally placed, difficult to insert, and easily dislodged; and the drainage tube can become occluded.7,12) To address these issues, we developed a new balloon, i.e., the Atom balloon, dedicated to uterine hemostasis. Insertion is often difficult when the uterus is extremely anteflexed or retroflexed. In addition, when the balloon catheter is inserted via the transabdominal (retrograde) approach during cesarean section, the proximal components of the catheter, which comprises two tubes for irrigation and drainage, can get stuck to the cervical tract and cannot be smoothly inserted. For this reason, we used a stylet for insertion and designed it to bundle the two proximal component tubes in one unit, thereby facilitating insertion.
The balloon is made of silicone, has an apple shape to prevent dislodgement, and can contain up to 500 ml of water. The balloon was also designed to prevent protrusion of the drainage port for blood from the balloon and exert consistent pressure even in the drainage tube. The drainage tube for blood was made circular to accelerate the flow of blood in the tube and prevent occlusion by blood clots.
When used in the clinical setting, the Atom balloon achieved hemostasis in all cases, although the present sample population was small. The Atom balloon was not dislodged or displaced, and its insertion did not cause cervical laceration or other complications. Operators of the Atom balloon noted that it was easy to insert owing to the stylet. Hemostasis was achieved by injecting 100–200 ml of saline. Because excessive injection can cause dislodgement, it is important to inject the minimal amount of water needed to achieve hemostasis. In contrast, 70–500 ml of saline is recommended for inflating a different uterine hemostatic balloon for postpartum hemorrhage,3) and typically 80–200 ml of saline is sufficient to achieve hemostasis with the Bakri balloon.12) Comparisons with other available balloons may provide further insight into the advantages of the Atom balloon.
Although the Atom balloon was used when blood loss became severe in some patients, it was used soon after the onset of hemorrhage in most patients. Because balloon hemostasis is difficult to achieve once massive blood loss results in the onset of coagulopathy, balloon tamponade may be more useful when performed soon after the onset of hemorrhage. Particularly in cases with a high risk of hemorrhage, such as placenta previa, low-lying placenta, placenta accreta, multiple gestation, and pregnancy complicated by leiomyoma, as well as cases where blood transfusion is not promptly available, prophylactic insertion of the balloon may be useful. Successful hemostasis was achieved in a patient with placental abruption complicated by coagulopathy, and hysterectomy was avoided. This demonstrates that balloon hemostasis is effective even in patients with coagulopathy if they receive sufficient replacement of coagulation factors. When patients with massive hemorrhage are transferred to a higher-level healthcare facility, it is preferable to apply gauze packing or balloon tamponade during the transfer, regardless of the onset of coagulopathy.11) This prevents unnecessary blood loss and deterioration of the patient’s general condition during transfer. The 2017 Japanese Guidelines for Treating Obstetric Critical Hemorrhage also recommend performing balloon tamponade in the early stages and that attention should be paid to abnormalities in vital signs, particularly the shock index.8,16) However, balloon insertion after vaginal delivery is ineffective for uterine rupture, and the damage caused by insertion can be problematic. Thus, sufficient caution should be exercised during balloon insertion.
The merits of balloon tamponade include a substantially reduced need to perform TAE and hysterectomy after both cesarean section and vaginal delivery. TAE is reportedly associated with the subsequent development of menstrual irregularity, ovarian failure, and infertility, as well as increased incidences of miscarriage, premature delivery, placenta accrete, and uterine rupture, which cause massive hemorrhage during delivery in subsequent pregnancies.12,14,17,18,19) Thus, balloon tamponade, which is a simple procedure, should be the first-line hemostatic procedure performed before invasive hemostatic procedures whenever possible. In this regard, an important concept in hemostasis is “minimally invasive hemostasis”.12)
According to a previous study, balloon tamponade was effective in patients with placental abruption complicated by disseminated intravascular coagulation (DIC).12) Even in patients with uterine hemorrhage that is difficult to control, hysterectomy can be avoided if damage control resuscitation, which consists of body rewarming, maintenance of hemodynamics, and replacement of coagulation factors are applied while the uterine cavity is adequately compressed by a balloon. Compression of the hemorrhage site and maintenance of a blood fibrinogen level ≥150 mg/dl lead to spontaneous improvement of uterine contractions and reduction of hemorrhage, thereby enabling hemostasis.14,20) If such a therapeutic strategy is widely adopted, hysterectomy and TAE may be needed less frequently, and fertility may also improve. We consider that minimally invasive hemostatic procedures that adhere to the “minimally invasive hemostasis” concept should be first selected to ensure the safety of the maternal body, as well as successful future pregnancies.12) Hemorrhage is caused by various factors and varies with respect to pathology, such that the chances of misjudgment and underestimation of the volume of blood loss increase. Thus, early application of balloon tamponade is important to ensure hemostasis in cases of obstetric hemorrhage. When hemorrhage does not stop even after balloon insertion, it is important to proceed to the next hemostatic procedure, administer additional treatment, or transfer the patient while the balloon remains inserted to reduce the amount of blood loss, rather than immediately removing the balloon.
Balloon tamponade is a minimally invasive and easy-to-perform hemostatic procedure. Since it is also effective for reducing hemorrhage in obstetric DIC, we hope this procedure is aggressively applied in the early stages of obstetric hemorrhage at all obstetric institutions.
Conflict of interest
No honorarium was received for the development of the balloon.
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