Fig. 16.1
Liquid flowing into balloon on uterine relaxation
Fig. 16.2
Excess liquid expelled into tank on uterine contraction
Using the principle of communicating vessels in filling the uterine balloon presents numerous crucial clinical benefits for the patient and the clinician. At any given moment of the procedure, the liquid volume is appropriate for maintaining constant pressure in the uterine cavity in spite of its changing dimensions, while the physician receives visual data on uterine activity via observing the changing level of the liquid in the tank, thus knowing precisely when to remove the balloon.
We have abandoned the drainage tube in the catheter design and established liquid volume limits for the balloon capacity, as well as the possibility of leaving any “dead” spaces in the uterine cavity during the balloon use. The cavity must be wholly occupied, the balloon covering all the potentially bleeding vessels without interfering with the spontaneous contractile activity of the uterus.
The existing well-known balloon, which leaves the upper part of the uterine cavity free, cannot reach the placental bed located in the fundus of the uterus.
The application of our system requires three steps only: (1) placing the pre-filled tank approximately 50 cm above the patient, (2) inserting the catheter into the uterus, and (3) connecting the catheter with the tank. Once the system is filled up with sufficient volume of liquid, all the rest is guided by the uterus itself.
We have created an open-circuit system where changes of the level of liquid in the tank serve as the intrauterine manometer registering early indications of the uterine contractility. Looking at the level, the physician observes spontaneous activity and natural might of the uterine forces.
Installing our system immediately after the manual exploration of the uterus when the bleeding continues requires several minutes only.
It is important that activating the uterine balloon system can be performed swiftly and on the spot, even in the emergency room or ambulance car, without any team, but rather by a single trained maternal provider along with any non-trained assistant or a relative of the patient. In the majority cases they result in the arrest of bleeding.
16.4 Preventing Expulsion of the Uterine Balloon
Intrauterine balloon tamponade procedure obviously requires maintaining the proper placement of the balloon in the uterus.
Our experience of BT use in PPH management has demonstrated its effectiveness in 97–98 % of elective CD cases when the cervix is closed and the catheter is introduced retrogradely through the uterine incision; for inflating and deflating of the balloon, its shaft is passed through the closed cervix into the vagina and outside.
BT is highly effective during the elective CD procedure due to the fact that the closed cervix excludes any possibility for an elastic and slippery balloon to be either expelled or displaced.
The balloon reliably maintains its position within the uterine cavity when the cervix is closed, and once it is filled with liquid, its contact with the inner surface of the uterus and direct pressure on the bleeding vessels are guaranteed. Thus BT appears to be inherently reliable and effective when the cervix is not open (Fig. 16.3).
Fig. 16.3
Uterine balloon in place. Maximum method efficacy (Elective CD)
However, performing BT when the cervix is dilated has resulted in a quite significant number of clinical cases where balloons were documented as protruding or being expelled.
This displacement of uterine balloon into the vagina through the dilated cervix can virtually be regarded as method failure (Fig. 16.4).
Fig. 16.4
Cervix open. Balloon expulsion
Moreover, balloon expulsion always makes possible the existence of concealed hemorrhage with blood accumulating in the uterine cavity behind the balloon with no outflow and remaining unobserved by the physician [20] (Fig. 16.5).
Fig. 16.5
Occult bleeding after balloon expulsion
As a consequence of this, there are a number of proposals regarding possible ways of maintaining the inflated balloon inside the uterine cavity.
Vaginal gauze packing was proposed as one of the ways to prevent balloon displacement. Unfortunately this approach can hardly be regarded as acceptable in cases of ongoing PPH due to the difficulties of applying sufficient counterpressure to maintain the balloon in the uterus as well as monitoring the loss of blood. Before using vaginal gauze packing to hold the balloon in place, the tamponade test must be positive. Otherwise there is a danger that the pack will conceal any ongoing bleeding and result in delaying the diagnosis of ineffective tamponade.
If vaginal gauze packing turns out to be unacceptable, then other ways of maintaining the balloon in the uterine cavity are required.
There are a number of different methods to keep the balloon inside via narrowing the dilated cervix, for example, using various kinds of sutures to encircle the opening cervix, such as cervical cerclage, cervical clamp, bilateral cervical lips suturing, etc. [21–24].
We would like to emphasize that the efficacy of arresting PPH with the uterine balloon when the open cervix is surgically narrowed is very high: in almost all cases, the bleeding ceases.
Our idea was to solve the problem of keeping the balloon properly positioned in the uterus without any surgical interventions by using a noninvasive technique. For this purpose, we created a mechanical device emulating the closed cervix, the autonomous vaginal balloon catheter. The device is placed into the vagina during the uterine tamponade procedure when the cervix is dilated.
To accomplish this task, the form, the softness, the external diameter, and the internal lumen of the shaft of the catheter were selected to imitate in the most accurate manner possible the shape of the closed cervix with its canal.
The balloon is mounted on the distal end of the shaft. By this balloon the vaginal catheter is safely and reliably fixed in the upper part of the vagina in direct contact with vaginal fornices.
The vaginal balloon catheter so designed emulates the closed cervix completely, even in the state of its full dilation, thus safely maintaining the uterine balloon inside the uterus immediately after vaginal delivery (Fig. 16.6).
Fig. 16.6
Vaginal balloon keeps uterine balloon in place with cervix open (modified from Antonio Malvasi Gian Carlo Di Renzo, Semeiotica Ostetrica. C.I.C. International Publisher, Rome, Italy, 2012)
In this manner the new double-balloon assembly system fits the unique anatomy of every patient; in fact, it can be regarded as a personalized dual-balloon catheter.
The important distinctive feature of DBAS is a wide gap between its shafts (Fig. 16.7).
Fig. 16.7
Gap between catheter shafts. Occult bleeding prevented
Due to this gap between the shafts of the two joined catheters, the obstetrician is immediately aware when BT is ineffective, as blood can be easily detected leaking outside through the gap between the balloon shafts.
16.5 Double-Balloon Assembly System: New Approach to Lower Segment Uterine Bleeding Management
Placenta previa remains a serious obstetric complication characterized by high morbidity and mortality rates for both the mother and the fetus due to the greater likelihood of catastrophic bleeding existing during the CD and in the postpartum period. This type of placentation is associated with significantly greater risks of hysterectomy, massive hemotransfusion, shock, and sepsis. Indeed, the hysterectomy rate in cases of placenta previa is 33-fold higher than in the elective CD control group [25].
Separating the placenta previa often leads to persistent uterine bleeding from the large open vessels at the placental site because the lower uterine segment is often poorly contracted, its myometrium thinner than in the body of the uterus. Also, thinness of the uterine wall often leads to deeper placental invasion in the lower segment.
If uterine body hemorrhages are usually well controlled with the application of ligatures to uterine vessels or the use of compression sutures, the lower uterine segment bleeding is often associated with unsuccessful devascularization, whereas compression sutures of the lower segment are technically challenging and require considerable experience on part of the surgeon; they also might lead to serious ischemic complications.
Uterine artery ligation is of no use in case of lower segment bleeding; those vessels supply the uterine body. On the other hand, internal iliac artery ligation does not interfere with lower uterine segment perfusion via additional blood supply through its well-developed network of arterial collaterals with many subperitoneal anastomoses [26]. It may be concluded that internal iliac artery ligation is not indicated in case of lower segment bleeding because it might prove insufficient or useless; its success rate is low, whereas the risks and complications outweigh the possible benefits. The situations when internal iliac artery ligation might be indicated will be discussed below.
Applying compression sutures in this situation requires good access to the lower uterine segment, the upper part of vagina, and the subperitoneal spaces of the pelvis. This kind of access necessitates wide and deep retrovesical dissection which is rather uncommon in obstetric practice, creates the risks of bladder damage and additional hemorrhage, and must be performed only by senior expert surgeons; only then accurate vascular control and efficacious use of hemostatic compression techniques become possible [27].
Compression square suturing by Cho is an effective method of hemostasis. However, it must be preceded by cannulating the cervical channel with Hegar’s dilator in order to provide for the outflow of uterine cavity contents. Also, when tightening the stitches the surgeon should simultaneously achieve sufficient compression of the hemorrhaging vessels and avoid uterine necrosis resulting from excessive ischemization. Overall, this invasive compression approach to lower uterine segment hemostasis involves nothing less than a difficult surgical operation with all its attendant risks [28].
Notwithstanding the foregoing, effective compression of the lower uterine segment, cervix, upper part of the vagina, and their respective parametria can be achieved in a totally noninvasive manner using mechanical means only. This area can be compressed between two voluminous elastic spherical objects and the two inflated balloons, one of which is placed into the uterus and the other one in the vagina. The DBAS assembled in situ, its two catheters moving independently of one another, gives us an opportunity to compress the lower uterine segment along with its attendant blood vessels in a thorough and careful manner.
To maximize the compression effect, we have developed the exact algorithm for installing DBAS. At the core of this technique is fixing the vaginal balloon as high as possible in the vagina in such a way that it contacts and expands vaginal fornices and flattens the cervix over the balloon surface; only thereafter we pour the required liquid volume into the uterine balloon, inserted and partially filled earlier. The expanding uterine balloon moves toward the fixed vaginal balloon and comes in tight contact with it (Fig. 16.8).
Fig. 16.8
Placenta previa. Inter-balloon compression of lower uterine segment
DBAS installed in the birth canal creates the necessary pressure on the bleeding lower segment of the uterus and the vessels supplying this area, obviating the need for a dangerous and complicated surgical intervention.
The success of this technique was confirmed by the Doppler ultrasound tests of the lower uterine segment that detected the absence of blood flow in this area, while DBAS was placed in the birth canal [29].
This approach toward stopping PPH is based on a simple, intuitive tool that can be applied easily and quickly by a young, non-experienced doctor. It presents the obstetrician with new opportunities for conservative treatment of hemorrhages, allowing some patients to avoid hysterectomy in the cases where it could otherwise been performed and thus preserve their reproductive function.
The lower uterine segment, heavily vascularized and characterized by minimal muscular contraction, is far from the best site for surgery. The regulated and safe compression provided by the two elastic smooth spheres of DBAS approximates the natural mechanism of hemostasis. Where muscular fibers are too weak to constrict the open vessels, the balloons vectoring their pressure upon the lower segment are optimal for arresting PPH and creating conditions that further the process of blood clotting.
16.6 Emergency Postpartum Hysterectomy
Certain among women giving birth will surely die if hysterectomy is not performed or performed with undue delay.
In spite of a great variety of scientific and practical endeavors directed toward the problem of PPH, hysterectomy remains an unavoidable treatment method. More often than not, it does not result from a medical error or substandard care.
In the situation where hysterectomy is a priori a life-saving measure for some patients, it is clear that identifying them as early as possible and performing hysterectomy in optimized conditions when their hemodynamics is stable would be a powerful tool in averting lethal outcomes or serious maternal morbidity, which so far remain formidable problems associated with emergency postpartum hysterectomy.
Elective obstetric hysterectomy in cases when the indications have been formulated during pregnancy and when it immediately follows CD in a preplanned manner, once all necessary preparations have been made and a team of senior obstetricians, anesthesiologists, urologist, oncologists, etc., have been assembled, is obviously less of a problem; it is characterized by greater success rates and a better safety profile [30].
However, the problems remain when hysterectomy is about to perform as the final event of intractable PPH management as an emergency surgical intervention.
How to perform it in the cases when hysterectomy is absolutely indicated – and avoid massive blood loss?
Rossi et al. (2010) have studied 981 cases of emergency postpartum hysterectomy and determined that 44 % of surgeries were performed with no alternative uterus-sparing procedures attempted [31]. In 56 % of cases, conservative procedures were tried but failed. The authors note certain existing problems, e.g., that the time elapsed while the procedures were applied might have contributed to greater maternal morbidity, blood loss volume, and blood transfusion rate. They underscore that there is no set of guidelines for conservative measures to be used before hysterectomy. Selecting the cutoff point for transition to hysterectomy remains a subjective decision.
Cognizant of the aforementioned problems, they suggest that conservative approaches are valid, while the hemodynamics of the woman is stable in the absence of life-threatening PPH.
Other publications put forward certain problems difficult to solve in the emergency situation of PPH. Baskett (2012) wrote that the art of obstetric judgment is necessary for establishing a certain balance between saving the uterus and saving the patient when choosing among extra time spent on uterus-preserving approaches and opting for the hysterectomy [32].
According to Knight (2007), in the UK the proportion of hysterectomy cases when morphologically intact uteri are removed is as high as 39 % [5].
In our opinion, in the clinically urgent acute situation of massive PPH, the obstetrician should have a clear reference point for making the decision to remove the uterus on a sound basis, knowing exactly which alternative procedures are worthy of consideration before transitioning to surgery. Here one cannot put one’s trust in the success of one’s subjective approach while in a situation of acute stress.
When we started wide use of DBAS in the group of women at the high risk of PPH and analyzed the results, we found that we have a clear reference point for transitioning to hysterectomy.
The sequence of DBAS application in CD cases was as follows: after extracting the fetus and before separating the placenta, we performed bilateral ligation of the descending branches of the uterine artery, and then, immediately after delivery of the placenta, we placed the balloon catheter into the uterus and applied external supraplacental pleated sutures, penetrating one-third of the uterine wall thickness, in two to three transverse rows. After closing the hysterotomy incision, the uterine balloon was immediately filled with liquid using the free flow method, the second balloon then being introduced into the vagina without delay and filled with 120–150 ml of liquid.
In cases of PPH during vaginal delivery when uterotonics were ineffective, after suturing the laceration and performing manual exploration of the uterus, we successively introduced and filled with liquid the uterine and vaginal catheters of DBAS.
The overall efficacy of DBAS application in the manner described above averaged 96 % over the last 2 years, whereas hysterectomy rate in our clinic dropped more than fourfold (3.6 per 1,000 births in 2015).
An important feature of hysterectomies following DBAS application is a significant reduction of blood loss (1,836 ± 108 ml versus 2,502 ± 203 ml, p = 0.04). It might be explained by the presence of two liquid-filled balloons, temporarily limiting perfusion of the uterus and upper third of the vagina, in the birth canal of the patient during surgery. Blood transfusion requirements have decreased almost twofold [29].
Our histological study of the uteri removed following DBAS application revealed gross structural changes, caused by suppurative endometritis or by the presence of epidermal scales in uterine arteries in one case and meconium in placental bed vessels in another case of symptomatic amniotic fluid embolism. Thus it is shown that in these cases the indications for hysterectomy were absolute and that the likelihood of arresting PPH using conservative methods was absent.
It should be emphasized that transition to hysterectomy, both in vaginal delivery and caesarean delivery cases, took place at once, without wasting time on any alternative conservative hemostatic techniques; subsequent analysis of clinical data fully justified the chosen tactics.
In other words, we can state that if PPH continues after DBAS use following either method of delivery, then we can assume a highly probable morphological cause of bleeding and transition to hysterectomy with confidence. In our experience, understanding the clinical situation usually comes before massive blood loss develops.
This new approach toward preventing lethal outcomes and PPH-associated serious morbidity can be regarded as the “DBAS test for hysterectomy.”
The absence of intact removed uteri shows that DBAS is efficacious in cases of PPH caused by functional uterine contractility impairment.
Such are the results obtained in our clinical practice. Further studies are required to examine DBAS use in more detailed clinical contexts.
16.7 Preventing Main Caesarean Delivery Complications: Our Mechanical Noninvasive Intraoperative Method
The incidence of PPH in cases of CD is double or even triple than in vaginal delivery cases [33–36] due to the presence of hysterotomy incision, which to a great extent damages the muscular layer of the uterus responsible for the first phase of hemostasis – constricting the open blood vessels of the placental bed.
The situation is aggravated when the incision is close to the placental site, the source of PPH.
At the same time, anatomic and physiological features of the uterus as the target of surgery limit the obstetrician’s ability to follow the basic rules of wound treatment, such as thorough hemostasis, necrotic tissue removal, and avoidance of dead spaces in the wound.
Even when the hysterotomy incision is perfectly stitched up and the bleeding from the wound has been securely stopped, the second, much more important and more dangerous PPH source, the placental bed, remains inside the uterus.
During the periods of slight, unapparent relaxation of the surgically injured myometrium which cannot be fully countered with uterotonics blood seeps into the uterine cavity out of placental site vessels that have not been fully constricted and not obstructed with blood clots.
It’s well known that hematometra is present to a greater or lesser degree in the majority of CD cases. The closed cervix greatly impairs the management of pathological accumulation of blood in the uterine cavity.
Also, the swiftly congealing blood accumulating in the closed cavity becomes the very “necrotic tissue” which serves as the breeding ground for bacterial growth causing uterine infections.
Thus “thorough hemostasis” and the “absence of necrotic tissue” remain unattainable.
We must underscore that the uterine cavity itself serves as the dead space under the just-closed hysterotomy incision.
What can be done with this cavity as the source of hemorrhagic and inflammatory complications in CD?
No structural alteration is possible because this space is a necessary anatomic part of the female reproductive system, responsible for pregnancy, menstruation, etc.; the uterine cavity evidently should not be destroyed. The obstetrician cannot permanently alter the uterine cavity while seeking to resolve temporary problems, limited to the first hours following CD.