Calling this approach “a stroke of brilliance,” James Byrne, MD, told Medscape Medical News that it “is much quicker and much simpler” than other techniques for managing postpartum hemorrhage and is less risky as well.
“This device can be placed in the uterus within a minute or so and does not need any initial anesthesia and would not be associated with the delay needed for a surgical approach,” Byrne explained. Byrne, who was not involved in the study, is chair of the Department of Obstetrics and Gynecology at Santa Clara Valley Medical Center in San Jose, California.
To test the efficacy and safety of the device (Jada System, Alydia Health, Inc), Mary E. D’Alton, MD, and colleagues conducted a prospective, observational treatment study in 12 US medical centers. They report their findings in an article published online September 9 in Obstetrics and Gynecology.
“The Jada System (novel intrauterine vacuum-induced hemorrhage-control device) was specifically designed to offer rapid treatment by applying low-level intrauterine vacuum to facilitate the physiologic forces of uterine contractions to constrict myometrial blood vessels and achieve hemostasis,” D’Alton, from New York–Presbyterian/Columbia University Irving Medical Center in New York City, and colleagues write.
“The device had a low rate of adverse events during this study, all of which were expected risks and resolved with treatment without serious clinical sequelae. Investigators, all first-time users of the device, found the system easy to use, which suggests that, after device education and with availability of a quick reference guide outlining steps, there is a minimal learning curve for use,” they add.
Alydia Health, Inc, the company that developed the device, funded this study and supported the research staff, who recruited participants and gathered follow-up data on them. On September 9, the US Food and Drug Administration granted 510(k) clearance for the device, according to a company news release.
The multicenter study included 107 patients (mean age, 29.7 years) with postpartum hemorrhage or abnormal postpartum uterine bleeding, 106 of whom received any study treatment with the device attached to vacuum. More than half (57%) of the participants were White, and just fewer than one quarter (24%) were Black.
Treatment was successful in 94% (100/106) of participants, with “definitive control of abnormal bleeding” occurring in a median of 3 minutes after attachment to vacuum.
Eight adverse events were judged to have been possibly related to the device or procedure: four cases of endometritis, and one case each of presumed endometritis, bacterial vaginosis, vaginal candidiasis, and disruption of a vaginal laceration repair. The eight adverse events were identified as potential risks, and all resolved without serious clinical consequences.
Thirty-five patients required transfusions of 1 to 3 units of red blood cells, and five patients required at least 4 units of red blood cells.
As many as 80% of postpartum hemorrhages are caused by uterine atony, according to the authors.
Byrne explained that the uterus is a muscular organ that contains many “spiral arteries” that are “squeezed” by the uterus as it tightens down after childbirth, which prevents them from bleeding excessively.
“With uterine atony, the uterus muscle doesn’t squeeze effectively, and therefore it’s not one or two arteries, it’s hundreds and hundreds of small arteries and capillaries [and] arterioles all bleeding; it’s a wide area of uterus,” he continued.
When medications alone are ineffective at controlling bleeding, tamponade is often added to put outward pressure on the inner wall of the uterus for 12 to 24 hours. Although tamponade is effective in approximately 87% of atony-related cases of postpartum hemorrhage, the use of outward pressure on the uterine walls “is counterintuitive if the ultimate goal is uterine contraction,” the authors write.
Byrne said he and his colleagues saw this device several years ago, and they felt at the time that it appeared to be “more intuitive to use vacuum to compress the uterus inward compared to the nonetheless valuable and effective Bakri balloon and other techniques that expand the uterus outward.”
The fact that there is no need for prophylactic antibiotics also sets the vacuum device apart from the Bakri balloon, use of which routinely involves administration of prophylactic antibiotics, Byrne said.
In the current study, 64% of participants were obese, making management of postpartum hemorrhage “really challenging” because it’s difficult to effectively massage the uterus through adipose tissue, Byrne explained. Patients with obesity “also have different hemodynamics for how effectively [injected medications will] be delivered to the uterus,” he added.
“A device like this that could be placed and works so efficiently — even with an obese patient — that’s actually very powerful,” Byrne said.
The discomfort experienced during placement of the device is similar to that experienced during sweeping of the uterus, Byrne explained. “You’d want a patient comfortable, ideally with an epidural already active, but if it’s an emergency, you wouldn’t have to wait for that; you could sweep the uterus quickly, place this, initiate suction, and it would all be so quick you could usually talk a patient through it and get it done,” Byrne continued.
Almost all of the investigators (98%) said the device was easy to use, and 97% said they would recommend it.
The vacuum device is made of medical-grade silicone and consists of an oval-shaped intrauterine loop at one end and a vacuum connector at the other end that can be attached to a standard suction cannister. On the inner side of the intrauterine loop are 20 vacuum pores covered by a shield that protects uterine tissue and prevents the vacuum pores from clogging with tissue or clotted blood.
Before insertion of the vacuum device, the clinician manually sweeps the uterus to identify retained placental fragments and to assess the uterine cavity. The distal end of the device is inserted into the uterus, and a cervical seal, positioned just outside the cervical os, is filled with 60 to 120 cc of sterile fluid. The proximal end is attached to low-level vacuum at a pressure of 80 ± 10 mmHg. The device is left in place with continued suction for at least 1 hour after bleeding is controlled, at which time the suction is disconnected and the cervical seal is emptied. The device remains in place for at least 30 minutes, during which the patient is observed closely.
“It looks like 75% to 80% of cases stop bleeding within 5 minutes…. Then you stop the pressure after an hour [and] wait at least 30 minutes. You could actually have this out of the patient’s body within 2 hours,” Byrne said.
The original article lists the authors’ relevant financial relationships. Byrne has disclosed no such financial relationships.
Obstet Gynecol. Published online September 9, 2020. Abstract
Troy Brown is an award-winning Medscape contributor with a special interest in infectious diseases, women’s health, and pediatrics.