Bakri Balloon Placement

Postpartum hemorrhage (PPH) is a life-threatening complication of delivery. It can occur after vaginal or cesarean delivery and is a major cause of maternal morbidity and mortality in both developing and developed countries as well. ^{[1, 2, 3]} The most common cause of PPH is uterine atony; up to 80% of the cases result from suboptimal contraction of the myometrium following placental separation.

After excluding other etiologies of PPH such as retained placenta, uterine rupture, genital tract trauma, uterine inversion, and coagulopathy, the management of uterine atony should be timely and initiated to prevent hemorrhagic, hypovolemic shock, dilutional coagulopathy, tissue hypoxia, and acidosis. The pituitary gland, the kidneys, and the lungs are particularly susceptible organs to damage when perfusion pressure decreases resulting in feared sequelae of postpartum hypovolemic shock such as Sheehan syndrome (ie, postpartum hypopituitarism), renal failure, and acute respiratory distress syndrome.

The repertoires of the management measures can be generally divided into operative and nonoperative interventions. In acute postpartum hemorrhage refractory to medical and other conservative interventions, invasive therapies may include arterial embolization, uterine compression sutures, uterine artery ligation, and, ultimately, hysterectomy. However, these measures are highly invasive, require extensive resources, expertise, and are associated with significant morbidities.

Intrauterine balloon tamponade has been suggested as an effective, easily administered minimally invasive treatment option to control uterine bleeding while preserving the mother’s ability to bear additional children. ^{[4, 5, 6]} Multiple types of balloons are available, including Bakri balloon, BT-cath balloon tamponade catheter, Foley catheters, Rusch balloon, condom catheters and the Sengstaken-Blakemore tube. The Bakri postpartum balloon ^[7] and the BT-cath balloon tamponade catheter ^[8] are specifically designed for postpartum intrauterine tamponade, and they are the only such devices approved by the US Food and Drug Administration for this application. ^[9] However, in settings where these are unavailable, other balloons can be used to achieve a similar effect.

In term of mechanism of action, the intrauterine balloon is believed to act by exerting inward to outward pressure against the uterine wall, resulting in a reduction in persistent capillary and venous bleeding from the endometrium and the myometrium. ^[10]

In 2006, the ACOG Practice Bulletin, published by the American College of Obstetricians and Gynecologists, made mention of the Bakri postpartum balloon for its specifically tailored design that enables conservative management of uterine bleeding in cases of uterine atony and other causes of PPH. ^[1] Global awareness and use of the Bakri postpartum device has grown steadily since 2006 as physicians, hospitals, and other medical institutions have sought effective, minimally invasive means to control uterine bleeding.

The Bakri balloon is used for temporary control or reduction of postpartum hemorrhage when conservative management of uterine bleeding is warranted, after bleeding from genital tract lacerations and retained product of conception has been excluded. The 2006 ACOG practice bulletin on postpartum hemorrhage by the American College of Obstetricians and Gynecologists states the following:

“When uterotonics fail to cause sustained uterine contractions and satisfactory control of hemorrhage after vaginal delivery, tamponade of the uterus can be effective in decreasing hemorrhage secondary to uterine atony. Such approaches can be particularly useful as a temporizing measure, but if a prompt response is not seen, preparations should be made for exploratory laparotomy.” ^[1]

Although the use of intrauterine balloon catheter is often successful and serves as a definite therapy, it can also be used as a temporary measure to decrease hemorrhage while waiting and preparing for other definite treatment, such as open abdominal surgery (ie, uterine artery ligation, uterine compression suture, hysterectomy) or uterine artery embolization, or while the patient is being transferred to another unit with more experience and resources.

Studies have used intrauterine balloons for bleeding following delivered pregnancies with low-lying placenta and/or placenta previa or invasive or adherent placenta and as an adjunctive treatment of cervical ectopic pregnancy with variable success. ^[11]

A study by Arakaki et al showed that the prophylactic use of Bakri balloon tamponade during and after cesarean section effectively controls blood loss in patients with major placenta previa. The frequency of massive postpartum hemorrhage (more than 500 mL) was lower in the patients who received balloon tamponade (2.4%) than in those who did not (16.7%). ^[12]

Few contraindications have been highlighted in the use of the Bakri. They include the following:

• Pregnancy

• Heavy arterial bleeding requiring surgical exploration or angiographic embolization

• Cervical cancer

• Congenital uterine anomaly

• Uterine distorting pathology (leiomyoma)

• Suspected uterine rupture

• Purulent infection of the vagina, cervix, or uterus

• Allergy to balloon material (silicone)

• Disseminated intravascular coagulation (DIC)

DIC is listed as a contraindication for balloon tamponade given the complete lack of clinical data. However, theoretically, it can be used to decrease the volume of bleeding and gain time to replenish blood products in preparation for more invasive surgical techniques.

Best Practices

The authors recommend that all procedures for management of postpartum hemorrhage be performed on the labor and delivery unit, with an operating room available if an emergency laparotomy becomes necessary.

Procedure Planning

Prior to the procedure, a bedside ultrasound should be used to help assess the uterine cavity to rule out retained product of conception and to assess the angulation and shape of the uterine cavity to help balloon catheter placement.

Complication Prevention

Complications related to intrauterine balloon placements are very rare but potentially include perforation of uterus during placement or inflation and cervical trauma due to inflation at an incorrect location. However, these complications have not been reported in the postpartum uterus. Infection has been reported, but determining whether it is related to the balloon placement is difficult.

To avoid potential risk of air embolism, the balloon should not be insufflated with air or carbon dioxide.

The Bakri balloon is a successful method for postpartum hemorrhage management, and this has been borne out by studies in recent years. ^{[13, 14, 15, 16]} Previously, most studies compared the effects of balloon tamponade and other methods to treat PPH, such as uterine compression sutures and arterial embolization, and concluded that no high quality evidence suggests that any one method of management of severe PPH was superior. ^[17] In a small case series, success rates of uterine balloon catheters for controlling hemorrhage ranged from 57% after cesarean delivery to 100% after vaginal delivery. ^{[4, 17, 18]}

The Bakri balloon has clear advantages compared to other intrauterine tamponade devices. These advantages are as follows ^[9] :

• Bakri balloon catheter is made of silicone, which is advantageous in patients with latex allergy.

• The shape more naturally conforms to the uterine cavity compared to other catheters.

• The risk of uterine perforation may be lower.

• It comes presterilized and ready to use, whereas the tip of the Sengstaken-Blakemore tube needs to be cut, has extra ports, and is more complicated to use.

To date, no evidence suggests that a Bakri balloon or any other intrauterine tamponade devices would decrease the future reproductive potential and/or would increase adverse pregnancy outcomes in subsequent pregnancies. The literature, however, is limited and further studies are needed. ^{[4, 19]}

A study by Kaya et al evaluated the B-Lynch uterine compression suture and Bakri balloon tamponade in severe postpartum hemorrhage and found that the Bakri balloon and the B-Lynch suture had similar success rates in uterine atony during cesarean section. The study added that the Bakri balloon is less invasive and easier to learn, but more time consuming and expensive compared to the B-Lynch suture. ^[20]