The simple solution for postpartum hemorrhage.

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Content Discussion Introduction Indications Steps for balloon application Comparison to existing manual treatments References Support info

Discussion

Discussion Postpartum hemorrhage (PPH) is defined as bleeding that occurs immediately after the placenta is delivered. PPH remains in the top five causes of maternal death in both developed and developing countries.

Discussion PPH is an emergent situation. The decision for appropriate treatment must be made in a matter of minutes. Proper treatment of PPH is multifactorial and can range from simple options to complex treatment. Patients with PPH can deteriorate very quickly.

Introduction

Introduction Severe bleeding is the single most significant cause of maternal death worldwide. More than half of all maternal deaths occur within 24 hours of delivery, most commonly from excessive bleeding.* *American College of Obstetricians and Gynecologists. ACOG practice bulletin: clinical management guidelines for obstetrician-gynecologists number 76. Obstet Gynecol. 2006;108(4):1039-1047.

Introduction Various management measures are used to control bleeding. Uterotonics Packing Manual compression Embolization Laparotomy Hysterectomy

Introduction An ideal management option would: Be easily administered and removed Control capillary/venous bleeding and surface oozing Gauge success of treatment in real time Avoid hysterectomy to preserve the patient’s reproductive potential

Introduction The Bakri Postpartum Balloon from Cook Medical: Is easily administered Allows quick determination of effectiveness Gauges ongoing blood loss through inner lumen Removes easily without need for separate surgical procedure Conservatively manages hemorrhage

Introduction The Bakri Postpartum Balloon: Is easily administered Will easily pass through a dilated cervix May be passed retrograde through a cesarean incision May be inflated quickly May be deflated quickly and removed if needed

Introduction The Bakri Postpartum Balloon: Effectiveness can be quickly ascertained Tamponade may be quickly ascertained when the balloon is placed If not effective, it may be easily removed May help temporize a patient while preparations for more aggressive treatments are made

Introduction The Bakri Postpartum Balloon: Gauges ongoing blood loss through inner lumen Drainage lumen of catheter with distal sideports allows real-time assessment of ongoing blood loss May prevent delayed treatment of concealed hemorrhage above level of the tamponade balloon

Introduction The Bakri Postpartum Balloon: Removes easily without need for separate surgical procedure Deflates in minutes Removes easily transvaginally

Introduction The Bakri Postpartum Balloon: Conservatively manages hemorrhage Is a simple yet effective tool that may help control uterine bleeding when uterotonic therapy fails

Indications

Indications The Bakri Postpartum Balloon catheter is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.

Indications NOTE: While the device is intended as a temporary means of establishing hemostasis in cases indicating conservative management of postpartum uterine bleeding, the application of this device should be concomitant with close monitoring for signs of arterial bleeding and/or disseminated intravascular coagulation (DIC).

Contraindications

Contraindications The use of this product is contraindicated in the presence of: Arterial bleeding requiring surgical exploration or angiographic embolization Cases indicating hysterectomy Pregnancy

Contraindications The use of this product is contraindicated in the presence of: Cervical cancer Purulent infections of the vagina, cervix or uterus Untreated uterine anomaly

Contraindications The use of this product is contraindicated in the presence of: Disseminated intravascular coagulation A surgical site that would prohibit the device from effectively controlling bleeding

Application

Application Vaginal Delivery: Transvaginal Placement Determine that the uterus is clear of any retained placental fragments, arterial bleeding or lacerations. Determine approximate uterine volume by ultrasound or direct examination. Under ultrasound guidance, insert the balloon portion of the catheter into the uterus, making certain that the entire balloon is inserted past the cervical canal and internal ostium.

Application Vaginal Delivery: Transvaginal Placement (cont.) Note: Avoid excessive force when inserting the balloon into the uterus. If not already indwelling, place a Foley catheter in patient bladder to collect and monitor urine output. To ensure maintenance of correct placement and maximize tamponade effect, the vaginal canal may be packed with iodine- or antibiotic-soaked vaginal gauze at this time.

Application Cesarean Delivery: Transabdominal Placement Determine that the uterus is clear of any retained placental fragments, arterial bleeding or lacerations. Determine uterine volume by intraoperative direct examination or postoperative ultrasound examination.

Application Cesarean Delivery: Transabdominal Placement (cont.) From above (via access of the cesarean incision), pass the tamponade balloon, inflation port first, through the uterus and cervix. Have an assistant pull the shaft of the balloon through the vaginal canal, until the deflated balloon base comes in contact with the internal cervical ostium.

Application Cesarean Delivery: Transabdominal Placement (cont.) Close the incision per normal procedure, taking care to avoid puncturing the balloon while suturing. If not already indwelling, place a Foley catheter in patient bladder to collect and monitor urine output. NOTE: Inflate the balloon after the hysterotomy incision is closed to avoid balloon puncture.

Application Cesarean Delivery: Transabdominal Placement (cont.) To ensure maintenance of correct placement and maximize tamponade effect, the vaginal canal may be packed at this time with iodine- or antibiotic-soaked vaginal gauze.

Application Instructions for balloon inflation: Note: Always inflate the balloon with sterile liquid. Never inflate with air, carbon dioxide or any other gas. Note: Do not overinflate the balloon. Please refer to product label for maximum inflation volume. Ensure that indwelling Foley is placed in patient bladder at this time.

Application Instructions for balloon inflation (cont.): To ensure that the balloon is filled to the desired volume, it is recommended that the predetermined volume of fluid be placed in a separate container, rather than solely relying on a syringe count to verify the amount of fluid that has been instilled into the balloon. Using the enclosed syringe, begin filling the balloon to the predetermined volume through the stopcock.

Application Instructions for balloon inflation (cont.): Apply gentle traction to the balloon shaft to ensure proper contact between the balloon and tissue surface. To maintain tension, secure the balloon shaft to the patient’s leg or attach to a weight, not to exceed 500 grams. Note: If balloon becomes dislodged due to shaft tension and cervical dilation, deflate, reposition and reinflate. Use of vaginal packing may be indicated at that time to aid in balloon placement.

Application – Balloon Dislodged

Application Patient Monitoring: Once balloon is placed and inflated, connect the drainage port to a fluid collection bag to monitor hemostasis. IMPORTANT: To adequately monitor hemostasis, the balloon drainage port and tubing should be flushed clear of clots with sterile isotonic saline. Patient should be monitored continuously for signs of increased bleeding, uterine cramping or a deteriorating condition. Patient monitoring should include, but not be limited to: Blood pressure, pulse, urine output, cramping, pallor and active bleeding.

Application Patient Monitoring (cont.): IMPORTANT: Signs of deteriorating or unimproving conditions should indicate more aggressive treatment and management of patient uterine bleeding. IMPORTANT: This device is not a substitute for surgical management and fluid resuscitation of life-threatening postpartum hemorrhage. IMPORTANT: Device should not be left indwelling for more than 24 hours.

Application Balloon Removal: Note: Maximum indwell time is 24 hours. Balloon may be removed sooner upon physician determination of hemostasis or the need to apply more aggressive treatment. Remove tension from balloon shaft. Remove any vaginal packing. Using an appropriate syringe, aspirate the contents of the balloon until fully deflated. Gently retract the balloon from the uterus and vaginal canal and discard. Continue to monitor the patient for signs of uterine bleeding.

Comparison

Comparison Bakri Postpartum Balloon Uterine Packing with Gauze Packaged with syringe and stores like other surgical tools. May be applied quickly and easily Open inner lumen allows for direct measurement of ongoing blood loss Silastic® balloon conforms to uterine cavity, decreasing chance of uterine trauma Can be removed quickly without additional invasive procedure Uterine Packing with Gauze Nominal material cost Possible concealed hemorrhage No record of blood loss Potential uterine trauma during application Removal post-treatment can require an additional trip to OR Silastic is a registered trademark of Dow Corning Corporation.

Comparison Sengstaken-Blakemore Balloon Foley Catheters Inexpensive Nasogastric balloon for tamponade of esophageal varicoceles and the introduction of contrast media Does not necessarily take uterine shape Expensive Contains latex Not indicated for management of PPH Foley Catheters Inexpensive Generally ineffective in a large, postpartum uterine cavity Application of multiple Foleys is cumbersome and less effective than the Bakri Postpartum Balloon If applied individually without an overbag, Foleys do not readily conform to uterine anatomy Foleys applied jointly in a plastic covering or overbag do not allow for proper drainage and can conceal uterine hemorrhage Contains latex Not indicated for management of PPH

Bakri Postpartum Balloon

Bakri Postpartum Balloon 100% silicone (no latex) Ductile shape allows it to conform to uterine anatomy and shape It allows for hemostatic cushion application and limits clot adhesion The large diameter lumen in the shaft and multiported, nonabrasive tip allows for constant drainage, so an ongoing uterine hemorrhage does not go undetected post-application Once deflated, the Bakri Balloon is easily removed transvaginally without the need for an additional surgical procedure FDA 510(k) clearance for specific application to postpartum hemorrhage

References

References American College of Obstetricians and Gynecologists. ACOG practice bulletin: clinical management guidelines for obstetrician-gynecologists number 76. Obstet Gynaecol. 2006;108(4):1039-1047. Bakri YN, Amri A, Abdul Jabbar F. Tamponade-balloon for obstetrical bleeding. Int J Gynaecol Obstet. 2001;74(2):139-142. Condous GS, Arulkumaran S, Symonds I, et al. The “tamponade test” in the management of massive postpartum hemorrhage. Obstet Gynecol. 2003;101(4):767-772. Dabelea V, Schultze P, McDuffie R. Intrauterine balloon tamponade in the management of postpartum hemorrhage. Am J Perinatol. 2007;24(6):359-364. Nelson WL, O’Brien JM. The uterine sandwich for persistent atony: combining the B-Lynch compression suture and an intrauterine Bakri balloon. Am J Obstet Gynecol. 2007;196(5):e9-e10. B-Lynch C, Keith L, Lalonde A, et al., eds. A Textbook of Postpartum Hemorrhage: A Comprehensive Guide to Evaluation, Management and Surgical Intervention. Duncow, Kirkmahoe, Dumfriesshire, UK: Sapiens Publishing; 2006. Bakri YN. Balloon device for control of obstetrical bleeding. Eur J Obstet Gynecol Reprod Biol. 1999;86:S84.

Support

Support FDA 510(k) Cleared: #KO62438 Tamponade Uterine Balloon Catheter Set Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Class: II Product Code: 85 KNA Market Clearance: 10/27/2006 Order Number: J-SOS-100500 Global Product Number: G30673