Novel intrauterine balloon tamponade systems for postpartum hemorrhage

Abstract

Introduction Postpartum hemorrhage is the most common cause of maternal death worldwide. Although intrauterine balloon tamponade has been widely used as an effective procedure to control atonic postpartum hemorrhage, intrauterine balloon tamponade fails to control postpartum hemorrhage in approximately one‐fifth of cases. The aim of this study was to evaluate the efficacy of novel intrauterine balloon tamponade systems for postpartum hemorrhage. Material and methods We have developed two novel intrauterine balloon tamponade systems to maintain proper balloon placement. One was a shaft cover with its fixture system and the other was “the Kyoto balloon system” designed to provide direct pressure onto the upper uterine cavity. The efficacy of the intrauterine balloon tamponade systems was evaluated using a silicone three‐dimensionally printed postpartum uterine cavity model. Results Measurements of balloon displacement during inflation showed that the shaft cover significantly prevented the Bakri balloon from being displaced. The residual fluid volume in the upper uterine cavity was significantly less with the Kyoto balloon system than with the Bakri balloon system, indicating the effectiveness of the Kyoto balloon for upper uterine cavity tamponade. Conclusions These innovative intrauterine balloon tamponade systems were effective for prevention of balloon displacement and for balloon tamponade of the upper uterine cavity in a 3D‐printed postpartum‐specific uterine cavity model.

CT scan assessment of intrauterine balloon tamponade failure for the treatment of atonic postpartum haemorrhage: implications for treatment

“…Recently, more and more facilities are managing severe PPH with emergency physicians, resulting in a gradual increase in the number of facilities performing CT scans. In severe atonic PPH, bleeding is thought to originate from the entire placental detachment plane; however, analysis of refractory atonic PPH using dCT or ultrasonography has shown that there is usually a single point of bleeding in the arterial phase, even in the presence of good uterine contractions 6,10–12 . In our analysis of refractory atonic PPH, no cases required arterial embolisation or hysterectomy in the absence of contrast extravasation in the arterial phase of dCT 11 .…”

“…On the other hand, when contrast extravasation is observed in the arterial phase of dCT, placement of a balloon in the uterus is often ineffective for achieving haemostasis 10,11 . This is refractory atonic PPH, which can be diagnosed by dCT, known as postpartum haemorrhage resistant to treatment showing arterial contrast extravasation on dynamic computed tomography (PRACE), which is considered a truly critical PPH 11,12 …”

“…In reality, CT images reveal that pregnancy stretches the lower part of the uterus which is consistent with the lower uterine segment, and lumen at the junction between body, and the lower uterine segment is narrowed as if there were two chambers in the uterus (Figure 1B). 11,12 The shape of the uterine cavity differs considerably between the upper and lower uterine cavity 10–12 . The morphology of the lower lumen of the uterus is ellipsoid, with the haemorrhage site concentrated laterally in the lumen at the border between the lower and upper uterus 11,12 .…”

Reply: The Kyoto balloon system for postpartum hemorrhage: A hard balloon shaft offers an easier and surer way to apply direct pressure on bleeding sites

“…We totally agree with Dr Matsubara et al's comment concerning possible patient discomfort associated with the use of ring forceps and novel intrauterine balloon tamponade systems for PPH. [1][2][3] Closing the uterine cervix with the vascular clips that they proposed 1 may solve the problem, as well as help to prevent expulsion of the balloon through the dilated cervix. However, it would take time to clamp the cervix using the vascular clips or ring forceps following placement of the intrauterine balloon.…”

“…4 As we explained in the Discussion section, a hard balloon shaft is a simple and effective approach for pressing the balloon against the bleeding sites. 3 The gripped shaft can be used also as a handle to replicate bimanual uterine compression without having one hand placed in the vagina ( Figure 1A). This maneuver modification may lessen patient discomfort and also enhance direct pressure sufficiently to stop the bleeding.…”