Treating PPH: A novel vacuum-induced hemorrhage control device
A new FDA-cleared device is an option for PPH management, but further studies are needed to evaluate its effectiveness compared with other devices for PPH. These experts, with experience in its use, explain how it works and discuss treatment success rates reported in a prospective study.
CASE continued What do other physicians think?
Your patient is curious about the time it takes for the device to work and whether other clinicians like using this new device for hemorrhage treatment.
Duration of treatment
The times to achieve uterine collapse and control of hemorrhage are both relatively short. In the prospective study, the initial collapse of the uterus took a median of 1 minute (IQR, 1–2 min) from the time of vacuum connection.6 Bleeding was controlled in less than 5 minutes in 82% of women, with an overall median time of 3 minutes (IQR, 2–5 min). The median duration of vacuum treatment was 144.0 minutes (IQR, 85.8–295.8 min), which includes the required minimum of 60 minutes for vacuum treatment time and 30 minutes of observation without the vacuum connected but with the device still in place.6
When polled, the majority of clinicians—98%—reported that the intrauterine vacuum-induced hemorrhage control device was easy to use, and 97% would recommend its use for future patients.6
Further, recognizing the device’s potential, the Cleveland Clinic cited it as one of the top 10 health care innovations for 2021 for offering a low-tech and minimally invasive tool for obstetric clinicians.15
CASE continued Final questions
Ms. B. thanks you for the information and asks, should she know anything else about the device?
Vacuum device vs other treatments
The study by D’Alton and colleagues was a single-arm treatment trial that did not directly compare the effectiveness of the device with that of other PPH treatment options, such as balloon tamponade.6 At this point, we know that clinicians can safely and quickly use the device to treat uterine atony, but we do not know if it is superior to other treatments for PPH.
Key takeaways
Postpartum hemorrhage is a leading cause of maternal morbidity and mortality. When first-line uterotonics fail, obstetric clinicians previously had only balloon tamponade or invasive procedures to treat patients. The novel intrauterine vacuum-induced hemorrhage control device takes a new approach that simulates the physiologic process of uterine contractions. The device can rapidly and effectively control abnormal postpartum uterine bleeding. More studies are needed, however, to compare the device’s effectiveness with that of other PPH treatments and to consider its use in women with more severe degrees of postpartum hemorrhage as well as its cost-effectiveness. ●
