Transcript Application - Handle Cook

The simple solution for
postpartum hemorrhage.
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
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.
• Nominal material cost
• May be applied quickly and easily
• No record of blood loss
• Open inner lumen allows for
direct measurement of ongoing
blood loss
• Potential uterine trauma during application
• Silastic® balloon conforms to
uterine cavity, decreasing chance
of uterine trauma
• Possible concealed hemorrhage
• Removal post-treatment can
require an additional trip to OR
• Can be removed quickly without
additional invasive procedure
Silastic is a registered trademark of Dow Corning Corporation.
Comparison
Sengstaken-Blakemore
Balloon
Foley Catheters
• Nasogastric balloon for tamponade
of esophageal varicoceles and the
introduction of contrast media
• Generally ineffective in a large, postpartum
uterine cavity
• Does not necessarily take
uterine shape
• Expensive
• Contains latex
• Not indicated for management
of PPH
• Inexpensive
• 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