Bakri balloon

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The Bakri balloon is a medical device invented and designed by Dr. Younes Bakri in 1999. [1]

Contents

The obstetrical balloon is a 24 French, 54 cm-long, silicone catheter with a filling capacity of 500 mL. The device is used for the temporary control and reduction of postpartum hemorrhage (PPH).

According to the World Health Organization, around 100,000 maternal deaths occur every year from PPH and is the leading cause of maternal mortality in the developed world. [2]

Uses

The Bakri balloon is a silicone, obstetrical balloon specifically designed to treat postpartum hemorrhage (PPH). The device is used for the "temporary control or reduction of postpartum hemorrhage when conservative management of uterine bleeding is warranted." [1]

Novel uses of the Bakri Balloon have been reported in the treatment of Empty Pelvis Syndrome (EPS), Gestational Trophoblastic Neoplasia (GTN) and uterine atony.

Collaborative research published in the British Journal of Surgery identified the Bakri Balloon as one of the devices used in mitigation strategies for EPS [3]

Soheila Aminimoghaddam et al. described an efficient method in preventing EPS by placing the Bakri Balloon in the pelvic cavity after exenteration. The results showed the balloon was a useful tool in providing "a physical barrier to prevent the descending of intestinal loops and a breeding ground for reconstruction of the pelvic floor". [4]

Between December 2019 and May 2022, Mufaddal Kazi et al. used the Bakri Balloon on 75 patients in a study to determine its efficacy in preventing EPS. They reported no complications. Although a larger comparative study was needed, deploying the Bakri Balloon was considered a safe method following pelvic exenteration. [5]

The Bakri Balloon was also seen as a "simple, safe and cost-effective method" to reduce EPS complications by S Bankar et al. when combined with other surgical techniques. [6]

The Bakri Balloon as a life saving technique to treat Gestational Trophoblastic Neoplasia (GTN) lesions was described by BG Goldman et al. after other attempts at managing GTN led to catastrophic bleeding and patient instability. Their recommendations included the balloon as a primary method for treatment. [7]

Zurich University Hospital used a modified Bakri balloon to treat 66 patients with uterine atony from March 2017 until June 2020. Christian Haslinger et al. connected the balloon to a vacuum device and applied 60–70 kPa vacuum. Their findings showed a success rate of 86%. [8]

Cases

One study in Finland [9] involving 50 patients recorded an overall success rate of 86% when using the Bakri balloon in managing PPH. A German study involving 20 patients cited an overall success rate of 90% when the balloon is used in combination with B-Lynch sutures. [10]

In 2023, a 4-year case study (2016–2020) in China involving 279 women was published and concluded that the Bakri balloon was an effective treatment in controlling postpartum hemorrhage. The overall success rate was 88.89% and supported those from previous studies. [11]

Endorsements

Both the International Federation of Gynaecology and Obstetrics (FIGO) and the International Confederation of Midwives (ICM) have approved the balloon as one of the primary support tools in treating PPH. [12]

In 2021, the World Health Organization recommended the Bakri Balloon as part of its guidelines to help reduce the maternal mortality ratio to less than 70 per 100,000 live births by 2030. [13]

See also

Related Research Articles

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Gestational trophoblastic disease (GTD) is a term used for a group of pregnancy-related tumours. These tumours are rare, and they appear when cells in the womb start to proliferate uncontrollably. The cells that form gestational trophoblastic tumours are called trophoblasts and come from tissue that grows to form the placenta during pregnancy.

Gestational choriocarcinoma is a form of gestational trophoblastic neoplasia, which is a type of gestational trophoblastic disease (GTD), that can occur during pregnancy. It is a rare disease where the trophoblast, a layer of cells surrounding the blastocyst, undergoes abnormal developments, leading to trophoblastic tumors. The choriocarcinoma can metastasize to other organs, including the lungs, kidney, and liver. The amount and degree of choriocarcinoma spread to other parts of the body can vary greatly from person to person.

<span class="mw-page-title-main">Complications of pregnancy</span> Medical condition

Complications of pregnancy are health problems that are related to, or arise during pregnancy. Complications that occur primarily during childbirth are termed obstetric labor complications, and problems that occur primarily after childbirth are termed puerperal disorders. While some complications improve or are fully resolved after pregnancy, some may lead to lasting effects, morbidity, or in the most severe cases, maternal or fetal mortality.

<span class="mw-page-title-main">Uterine artery embolization</span>

Uterine artery embolization is a procedure in which an interventional radiologist uses a catheter to deliver small particles that block the blood supply to the uterine body. The procedure is primarily done for the treatment of uterine fibroids and adenomyosis. Compared to surgical treatment for fibroids such as a hysterectomy, in which a woman's uterus is removed, uterine artery embolization may be beneficial in women who wish to retain their uterus. Other reasons for uterine artery embolization are postpartum hemorrhage and uterine arteriovenous malformations.

<span class="mw-page-title-main">Trophoblastic neoplasm</span> Medical condition

Gestational trophoblastic neoplasia (GTN) is group of rare diseases related to pregnancy and included in gestational trophoblastic disease (GTD) in which abnormal trophoblast cells grow in the uterus. GTN can be classified into benign and malignant lesions. Benign lesions include placental site nodule and hydatidiform moles while malignant lesions have four subtypes including invasive mole, gestational choriocarcinoma, placental site trophoblastic tumor (PSTT) and epithelioid trophoblastic tumor (ETT). The choriocarcinoma has 2 significant subtypes including gestational and non-gestational and they are differentiated by their different biological feature and prognosis. Signs and symptoms of GTN will appear vary from person to person and depending upon the type of the disease. They may include uterine bleeding not related to menstruation, pain or pressure in pelvis, large uterus and high blood pressure during pregnancy. The cause of this disease is unknown but the identification of the tumor based on total beta-human chorionic gonadotropin (β-hCG) in the serum.

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<span class="mw-page-title-main">Balloon tamponade</span>

Balloon tamponade is the use of balloons inserted into the esophagus, stomach or uterus, and inflated to alleviate or stop refractory bleeding.

<span class="mw-page-title-main">Uterine atony</span> Loss of tone in the uterine musculature

Uterine atony is the failure of the uterus to contract adequately following delivery. Contraction of the uterine muscles during labor compresses the blood vessels and slows flow, which helps prevent hemorrhage and facilitates coagulation. Therefore, a lack of uterine muscle contraction can lead to an acute hemorrhage, as the vasculature is not being sufficiently compressed. Uterine atony is the most common cause of postpartum hemorrhage, which is an emergency and potential cause of fatality. Across the globe, postpartum hemorrhage is among the top five causes of maternal death. Recognition of the warning signs of uterine atony in the setting of extensive postpartum bleeding should initiate interventions aimed at regaining stable uterine contraction.

<span class="mw-page-title-main">Carboprost</span> Chemical compound

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<span class="mw-page-title-main">Postpartum bleeding</span> Loss of blood following childbirth

Postpartum bleeding or postpartum hemorrhage (PPH) is often defined as the loss of more than 500 ml or 1,000 ml of blood following childbirth. Some have added the requirement that there also be signs or symptoms of low blood volume for the condition to exist. Signs and symptoms may initially include: an increased heart rate, feeling faint upon standing, and an increased breathing rate. As more blood is lost, the patient may feel cold, blood pressure may drop, and they may become restless or unconscious. In severe cases circulatory collapse, disseminated intravascular coagulation and death can occur. The condition can occur up to twelve weeks following delivery in the secondary form. The most common cause is poor contraction of the uterus following childbirth. Not all of the placenta being delivered, a tear of the uterus, or poor blood clotting are other possible causes. It occurs more commonly in those who already have a low amount of red blood, are Asian, have a larger fetus or more than one fetus, are obese or are older than 40 years of age. It also occurs more commonly following caesarean sections, those in whom medications are used to start labor, those requiring the use of a vacuum or forceps, and those who have an episiotomy.

<span class="mw-page-title-main">Uterine inversion</span> Medical condition

Uterine inversion is when the uterus turns inside out, usually following childbirth. Symptoms include postpartum bleeding, abdominal pain, a mass in the vagina, and low blood pressure. Rarely inversion may occur not in association with pregnancy.

<span class="mw-page-title-main">Non-pneumatic anti-shock garment</span> Device used to treat hypovolemic shock

The non-pneumatic anti-shock garment (NASG) is a low-technology first-aid device used to treat hypovolemic shock. Its efficacy for reducing maternal deaths due to obstetrical hemorrhage is being researched. Obstetrical hemorrhage is heavy bleeding of a woman during or shortly after a pregnancy. Current estimates suggest over 300,000 women die from obstetrical hemorrhage every year with 99% of cases occurring in developing countries; many of these deaths are preventable. Many women in resource-poor settings deliver far from health-care facilities. Once hemorrhage has been identified, many women die before reaching or receiving adequate treatment. The NASG can be used to keep women alive until they can get the treatment they need.

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The following outline is provided as an overview of and topical guide to obstetrics:

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<span class="mw-page-title-main">B-Lynch suture</span> Compression suture used in obstetrics

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Uterine balloon tamponade (UBT) is a non-surgical method of treating refractory postpartum hemorrhage. Once postpartum hemorrhage has been identified and medical management given, UBT may be employed to tamponade uterine bleeding without the need to pursue operative intervention. Numerous studies have supported the efficacy of UBT as a means of managing refractory postpartum hemorrhage. The International Federation of Gynecology and Obstetrics (FIGO) and the World Health Organization (WHO) recommend UBT as second-line treatment for severe postpartum hemorrhage.

References

  1. 1 2 "Bakri® Postpartum Balloon with Rapid Instillation Components". Cook Medical Products.
  2. ↑ Abouzahr, C (1998). "Antepartum and postpartum haemorrhage". In Murray, Christopher J. L.; Lopez, Alan D. (eds.). Health Dimensions of Sex and Reproduction: The Global Burden of Sexually Transmitted Diseases, HIV, Maternal Conditions, Perinatal Disorders, and Congenital Anomalies. Harvard School of Public Health. pp. 172–174. ISBN   978-0-674-38335-7.
  3. ↑ PelvEx Collaborative, The empty pelvis syndrome: a core data set from the PelvEx collaborative, British Journal of Surgery, Volume 111, Issue 3, March 2024, znae042, https://doi.org/10.1093/bjs/znae042
  4. ↑ Aminimoghaddam, S., Hivehchi, N.,Ghaemi,M.,Eshghinejad, A.,& Yazdizadeh, M. (2022). Using Bakri balloon as a visceral replacement for occupying pelvic cavity in pelvic exenteration, a case report. International journal of surgery case reports, 99, 107646. https://doi.org/10.1016/j.ijscr.2022.107646
  5. ↑ Kazi, M., Desouza, A., Bankar, S., Jajoo, B., Dohale, S., Vadodaria, D., Ghadi, A., Ghandade, N., Vasudevan, L., Nashikkar, C., & Saklani, A. (2023). The use of an obstetric balloon as a pelvic spacer in preventing empty pelvis syndrome after total pelvic exenteration in rectal cancers - A prospective safety and efficacy study for the Bakri balloon. Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland, 25(4), 616–623. https://doi.org/10.1111/codi.16424
  6. ↑ Bankar, S., Desouza, A., Paliwal, V., Pandey, D., Gori, J., Sukumar, V., Rohila, J., & Saklani, A. (2020). Novel use of the Bakri balloon to minimize empty pelvis syndrome following laparoscopic total pelvic exenteration. Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland, 22(12), 2322–2325. https://doi.org/10.1111/codi.15319
  7. ↑ Goldman, Makhathini, Ludwaba. Novel use of the Bakri postpartum balloon in gestational trophoblastic neoplasia with bleeding vaginal metastatic lesions refractory to conventional treatment modalities Southern African Journal of Gynaecological Oncology, 2024-06-01,16(1): 1-4 https://journals.co.za/doi/full/10.36303/SAJGO.384
  8. ↑ Haslinger,C., Weber K., & Zimmermann,R.(2021). Vacuum-Induced Tamponade for Treatment of Postpartum Hemorrhage. Obstetrics and gynecology, 138(3), 361–365. https://doi.org/10.1097/AOG.0000000000004510
  9. ↑ Grönvall, Maiju; Tikkanen, Minna; Tallberg, Erika; Paavonen, Jorma; Stefanovic, Vedran (2013). "Use of Bakri balloon tamponade in the treatment of postpartum hemorrhage: A series of 50 cases from a tertiary teaching hospital". Acta Obstetricia et Gynecologica Scandinavica. 92 (4): 433–438. doi:10.1111/j.1600-0412.2012.01531.x. PMID   22913383. S2CID   2851504.
  10. ↑ Diemert, Anke; Ortmeyer, Gerhard; Hollwitz, Bettina; Lotz, Manuela; Somville, Thierry; Glosemeyer, Peter; Diehl, Werner; Hecher, Kurt (2012). "The combination of intrauterine balloon tamponade and the B-Lynch procedure for the treatment of severe postpartum hemorrhage". American Journal of Obstetrics and Gynecology. 206 (1): 65.e1–65.e4. doi:10.1016/j.ajog.2011.07.041. PMID   22000893.
  11. ↑ Xiao, C.; Wang, Y.; Zhang, N.; Sun, G. Q. (2023). "Bakri Balloon for Treatment of Postpartum Hemorrhage: A Real-World 2016–2020 Study in 279 Women from a Single Center". Medical Science Monitor. 29: e938823-1-e938823-9. doi:10.12659/MSM.938823. PMC   9987168 . PMID   36855288.
  12. ↑ Lalonde, André (May 2012). "Prevention and treatment of postpartum hemorrhage in low-resource settings". International Journal of Gynecology & Obstetrics. 117 (2): 108–118. doi:10.1016/j.ijgo.2012.03.001. PMID   22502595. S2CID   34206676.
  13. ↑ WHO recommendation on uterine balloon tamponade for the treatment of postpartum haemorrhage. World Health Organization. 2021. hdl: 10665/340796 . ISBN   978-92-4-001384-1.[ page needed ]
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