Efficacy of the tourniquet hemostasis combined with vaginal balloon tamponade using a Zhukovsky vaginal catheter during delivery in placenta accreta spectrum

Obstetric hemorrhage continues to be the leading cause of maternal mortality, ranging from 19.9% to 36.2%, and is responsible for 127 000 deaths of women of reproductive age annually [1, 2]. A significant proportion of massive obstetric hemorrhage is associated with the placenta accreta spectrum. Year by year, the number of these patients is increasing, which is directly associated with increased rates of abdominal delivery. Over the past 50 years, their number has increased 10 times [3].

The accumulated evidence suggests an increase in the risk of the placenta accreta spectrum with each subsequent cesarean section (CS), which in turn, increases the risk of maternal morbidity and mortality [4]. To date, there is a proven relationship between the increasing number of C-sections and the frequency of abnormal placentation. Moreover, the risk of placenta accreta spectrum in the uterine scar increased by 7 times after one previous CS and by 56 times after three or more operations [5].

Currently, there is no unified approach to the treatment of patients with placenta accreta spectrum; surgical techniques vary from country to country [6]. Surgical strategies include non–organ-sparing (primary or delayed hysterectomy) and organ- sparing approaches.

In most countries, traditional surgical treatment of the antenatally diagnosed placenta accreta spectrum is planned early operative delivery and single-step hysterectomy [7–9]. CS with a fundal uterine incision, fetal extraction, and hysterectomy without an attempt to remove the placenta significantly reduces blood loss [10]. This strategy is considered the standard of care, recommended by most specialized centers in the United States and the American College of Obstetricians and Gynecologists (ACOG); only 14.9–32.0% of specialists choose conservative methods (leaving the placenta in situ) [11, 12]. According to an international 2018 survey, about 60% of specialists prefer radical surgery for the placenta accreta spectrum [13].

The current study aimed to evaluate the efficacy of distal tourniquet hemostasis combined with vaginal balloon tamponade using a Zhukovsky vaginal catheter during delivery of pregnant women with placenta accreta spectrum to reduce intraoperative blood loss.

Materials and methods

A prospective observational study included 164 pregnant women with histologically confirmed placenta accreta spectrum who underwent surgery with distal tourniquet hemostasis at the Vidnovsky Perinatal Center from 2017 to 2022. The patients were divided into Group 1 (study group, n=133) and Group 2 (control group, n=31) who had and did not have vaginal balloon tamponade in addition to distal tourniquet hemostasis, respectively.

Inclusion criteria were age 18–45 years, singleton pregnancy, placenta accreta spectrum, uterine scar after previous CS, and abnormal placental implantation.

Exclusion criteria were multiple pregnancies, severe maternal somatic comorbidities, delivery before 26 weeks of gestation, and fetal malformations incompatible with life.

Placenta accreta spectrum is diagnosed by antenatal ultrasound examination. Typical ultrasound characteristics of the placenta accreta spectrum include the absence of a hypoechogenic retroplacental space, bladder-wall interruption, abnormal placental lacunae, placental hypervascularity, aberrant vessels penetrating the posterior wall of the bladder. The labor management strategy was individually tailored by a multidisciplinary Concilium with the participation of obstetricians, neonatologists, anesthesiologists, and a transfusion medicine specialist.

The primary endpoint of the study was the possibility of reducing intraoperative blood loss during distal tourniquet compression hemostasis in combination with vaginal balloon tamponade using the Zhukovsky vaginal catheter versus distal tourniquet compression hemostasis only during delivery of pregnant women with placenta accreta spectrum. For this purpose, intraoperative blood loss, measured by the gravimetric method, and analysis of perioperative hemoglobin level dynamics were performed in both groups. Volumes of intraoperative reinfusion of washed red blood cells and donor blood components were also evaluated. The second endpoint of the study was the effect of the compared surgical treatment methods of the placenta accreta spectrum on its outcomes for patients. For this purpose, a comparative analysis of complications, operative time and hospital length of stay was performed.

Statistical analysis

Statistical analysis was performed using MS EXCEL 2010 and Statistica 10 software (StatSoft., Russia). Descriptive statistics included median (Me), 25% and 75% percentiles (P25 and P75); nonparametric tests were used to determine the significance of differences. Binary variables are presented as counts and percentages. Continuous variables were compared with the Mann–Whitney U test. Categorical variables were compared using the Chi-square test (χ2) or Fisher's exact test. The final results for binary outcomes were reported using odds ratios (OR) with 95% confidence intervals (CI). The significance threshold was defined as p<0.05.

Results

There were no differences between the study groups in age, body mass index, and number of previous CSs (Table 1). The mean age of patients was 35 years in Group 1 and 33 years in Group 2, which was aimed at preserving the reproductive function.

The method consists of combining distal compression hemostasis with the simultaneous use of tourniquets and vaginal balloon tamponade with a Zhukovsky vaginal catheter. The method is shown in the figures (Fig. 1–3).

After performing a lower abdominal midline incision passing around the umbilicus, the fetus was extracted via uterine fundus CS, then the umbilical cord was cut and immersed in the uterus, and the placenta was not separated. The uterine fundal incision was closed by two rows with separate Vicryl sutures.

The Zhukovsky vaginal catheter was inserted during the uterine incision closure and filled with 180–200 ml of physiological solution (Fig. 1), ensuring compression (tamponade) of the vaginal branches of the uterine and pudendal arteries. The first uterine tourniquet was placed along the upper edge of the uterine aneurysm around the uterus, capturing the broad uterine ligaments with fallopian tubes on both sides in a single block. When the first uterine tourniquet was placed, the ascending branches of the uterine arteries and ovarian arteries were clamped. Then the peritoneum of the vesicoureteral fold was dissected. Large vessels were ligated and cut, and small vessels were coagulated. The bladder was mobilized to the border of healthy uterine tissue (to the lower edge of the uterine aneurysm). The second uterine tourniquet was placed around the uterus at the level of the lower edge of the uterine aneurysm in a single block with capture of broad uterine ligaments. The ureteral arteries were clamped while the second tourniquet was applied. Then, the dehiscent uterine wall was dissected, including uterine aneurysm with a placental implantation site within healthy tissues. Remaining placental tissue was removed manually and surgically. The placental site was sutured with separate Vicryl sutures, if necessary. Then, the lower uterine segment was closed by two rows with separate Vicryl sutures. The tourniquets were removed. The wound to the anterior abdominal wall was tightly sutured. The vaginal catheter was removed 4–6 hours after its placement.

The volume of intraoperative blood loss, which was assessed by the gravimetric method, was the key indicator of hemostasis efficiency in our study. Intraoperative blood loss volume in Group 1 was lower than in Group 2. The median volume of intraoperative blood loss in groups 1 and 2 was 959 (699; 1651) and 1549 (899.5; 2098) ml (p=0.03), respectively. At the same time, hemoglobin levels before delivery were comparable in both groups. In the postoperative period there was a decrease in hemoglobin in Group 2 where isolated distal compression hemostasis with tourniquet was performed compared to Group 1 where distal compression hemostasis with tourniquet was combined with vaginal balloon tamponade using a Zhukovsky catheter. The volume of autotransfusion in the study group was 208 ml versus 485 ml in the comparison group. The differences were significant (p<0.05, Mann–Whitney test) (Table 2). Transfusion of packed red blood cells was required in 12/133 (9%) cases in the study group, and in 13/31 (42%) cases in the comparison group. The findings indicated a high frequency of donor red blood cell transfusion in the comparison group, with an OR value of 7.3 (95% CI 2.88–18.42; p=0.00004). Transfusion of donor fresh frozen plasma was performed more frequently in Group 2 – 12/31 (38.7%) than in Group 1 – 2/133 (1.5%). The OR was 41.4 (95% CI 8.6–199.3; p<0.0001). There were no significant differences between the groups in terms of operative time and hospital length of stay after surgery.

The structure of the complications is presented in Table 3. It should be noted that organ-sparing surgery in the study group (n=133) was performed in 133/133 (100%) cases, in the control group (n=31) in 29/31 (93.5%) (p=0.03). Damage to the ureters was not observed in any group. Relaparotomy was required in 2/133 (1.5%) cases in Group 1 and 2/31 (6.5%) cases in Group 2, respectively (p=0.16). The indication for relaparotomy in Group 2 was bleeding in the early postoperative period (n=2), and in Group 1 we performed relaparotomy in the delayed postoperative period due to pelvic abscess (n=1) and development of dynamic intestinal obstruction (n=1). Intraoperative uterine hypotension was observed in Group 1 in 8/133 (6%) cases, in Group 2 in 4/31 (13%) cases. Compression sutures were used in all cases when this complication developed. There was no bleeding in the postoperative period in the study group. Vesicoureteral fistulas were diagnosed in 1/133 (0.75%) and 2/31 (6.5%) a month after surgery in Groups 1 and 2, respectively (p=0.09). In Group 1, the fistula subsequently closed spontaneously, while in Group 2 it required excision of the vesicoureteral fistula, in one case using laparoscopic access, and in the other using laparotomy. In one case, the study group patient was diagnosed with obstructive pyelonephritis in the postoperative period due to edema of the ureters against the background of their catheterization before surgery. Thus, the complications during the surgical intervention with the tourniquet hemostasis method were minimal.

Discussion

Organ-sparing surgery in pregnant women with a placenta accreta spectrum aims to preserve the uterus and reproductive function. Palacios-Jaraquemada JM was first proposed in 2004 to dissect the uterine wall in the area of the placenta accreta spectrum with further reconstruction of the uterus. [14, 15]. The extraction of the fetus was performed through a fundal uterine incision after ligation of the newly formed vessels between the uterus and the bladder. The placenta and the uterine wall were dissected in one block within healthy tissues with further restoration of uterine integrity.

In Russia, Kurtser, MD, was the founder of organ-sparing surgery in pregnant women with placenta implantation on a previous uterine scar. Initially, ligation of the internal iliac arteries was performed for hemostasis and compression sutures were applied to the uterus [16, 17]. Later, temporary balloon occlusion of the common iliac arteries was introduced into practice. The use of this technique led not only to a decrease in the number of patients with massive blood loss, but also to a decrease in the median blood loss in the remaining patients, which was 1000-1450 ml [18].

The method of distal compression hemostasis using tourniquets has become an alternative to endovascular methods [19, 20]. The method consists of the following: after performing CS by fundal uterine incision and suturing the uterus in the broad ligaments at the level of the isthmus, "windows" were formed on both sides, through which tourniquets were applied along the uterine side. Further, a third tourniquet was placed through the same windows and tightened, after which uterine aneurysm dissection was performed [21]. The advantages of this method were that there was no need to use expensive equipment for balloon vessel occlusion, as well as a significant reduction in intraoperative blood loss. The authors of China reported similar findings in a study investigating the tourniquet technique [22].

In 2019, the method of surgical delivery of patients with placenta accreta spectrum using distal compression hemostasis with the use of tourniquets was developed and patented at the Vidnovsky Perinatal Center. Later, this method was supplemented by vaginal tamponade with a Zhukovsky vaginal catheter [23, 24].

The proposed method was used in the surgical delivery of 133 pregnant women with the placenta accreta spectrum. Organ-sparing surgery was performed in 100% of the cases. There was no need for transfusion of donor blood components. The duration of the operation was averaged 109 minutes; mean blood loss was 959 ml; mean blood reinfusion volume was 208 ml; mean hospital stay was 5 days.

Our study showed the advantages of the proposed method for organ sparing surgery in patients with placenta accreta spectrum. The simplicity and accessibility of hemostasis is achieved due to the following factors: mobilization and constriction of the common iliac arteries is excluded, imposition of circular tourniquets does not require additional mobilization of surrounding tissues. Reliability of hemostasis is increased by temporary cessation of blood flow in the distal vascular bundles from various main sources of uterine blood supply: uterine and ovarian arteries. Installation of the Zhukovsky vaginal catheter allows additional compression of the vaginal branches of the uterine arteries and the pudendal arteries, preventing bleeding at these stages of surgical delivery. The use of distal compression hemostasis using tourniquets in combination with vaginal balloon tamponade with Zhukovsky vaginal catheter reduces the amount of blood loss by clamping the maximum number of vessels providing the uterine blood supply. The proposed method can be performed by an obstetrician gynecologist without the involvement of a vascular surgeon. An ischemic zone occurs between the two tourniquets, allowing the operating obstetrician-gynecologist to work practically in the "dry" surgical field.

Conclusion

The proposed method of distal compression hemostasis using tourniquets in combination with vaginal balloon tamponade with the Zhukovsky vaginal catheter in patients with placenta accreta spectrum resulted in a 1.6-fold decrease in blood loss compared to distal tourniquet hemostasis alone. At the same time, the number of complications in the study group was minimal, which significantly reduced the number of transfusions of packed red blood cells and fresh frozen plasma, as well as shortened the time of rehabilitation in the postoperative period due to the preservation of hemoglobin levels closer to normal values.