Materials and Methods

In April of 2010, a dual-balloon tamponade catheter, the Belfort-Dildy Obstetrical Tamponade System (BD-OTS), trade-named “ebb ^” (Glenveigh Medical, LLC, Chattanooga, TN), received clearance by the Food and Drug Administration for use in the provision of temporary control or reduction of postpartum bleeding. The description of the device is summarized in the Figure .

The Belfort-Dildy Obstetrical Tamponade System

The sterile single-use dual-balloon tamponade catheter trade-named “ebb” (Glenveigh Medical, Chattanooga, TN), also referred to as the Belfort-Dildy Obstetrical Tamponade System, features an upper uterine balloon (maximum recommended fill volume 750 mL) and a lower vaginal balloon (maximum recommended fill volume 300 mL). Each balloon can be filled easily by attaching an intravenous fluid bag to the in-line “spike” and manually filling the balloon by squeezing the intravenous bag that contains isotonic solution in increments that start at 250 mL; the volume is increased gradually until tamponade is achieved. Each balloon can be moved independently of each other to accommodate maternal anatomy properly. A third port allows for irrigation above the uterine balloon, and a central drain allows for monitoring of possible ongoing or recurrent hemorrhage from above the uterine balloon. Each balloon can be rapidly or gradually deflated in an independent fashion.

Dildy. Dual-balloon tamponade catheter for PPH. Am J Obstet Gynecol 2014 .

Image provided by Glenveigh Medical.

This report is from a postmarketing surveillance study of BD-OTS cases from 20 clinical sites in the United States (Acknowledgments). A local study coordinator completed a case report form after each case was concluded. Data were obtained from the hospital medical record and by interview with the involved clinicians. All case report form data that included questions regarding efficacy were addressed by the local study coordinators (and not by the manufacturer).

The study protocol was approved by an investigational review board at each site. The study was registered with ClinicalTrials.gov ( NCT01198652 ), and informed consent requirements (eg, written, verbal) from each of the respective investigational review boards were satisfied for all subjects. The purpose of the study was to assess the overall benefit and safety of the BD-OTS in actual clinical practice. Distribution data are reported as median (range) values and proportions; statistical calculations were performed with SAS software (version 9.2; SAS Institute Inc, Cary, NC).

Results

The study was initiated in September 2010 and was discontinued in October 2012 after enrollment of 57 cases. Case data were collected and submitted by 11 of the participating 20 sites. Of the 57 women enrolled, 55 women had the diagnosis of PPH, and 2 women had other diagnoses and indications (1 catheter was used as PPH prophylaxis in a patient who received anticoagulation; 1 catheter was used for a vaginal cuff surgical procedure in a 59-year-old woman 30 days after hysterectomy with placement via a colpotomy). Of the 55 women with PPH, the uterine balloon was placed within the uterine cavity in 51 cases and was not inserted in the uterus in 4 cases (1 case was a catheter that was placed as a pelvic pressure pack after hysterectomy for PPH; 1 case was a failed insertion in a 16-year-old patient with PPH 12 hours after delivery; 1 case was a vaginal placement of the uterine balloon after hysterectomy for PPH to facilitate vaginal cuff repair; and 1 case was for PPH from vaginal lacerations whereby the uterine balloon was inflated in the vagina and the vaginal balloon was inflated externally).

The study population described herein includes the 51 women with a diagnosis of PPH who had the BD-OTS placed according to product labeling (ie, uterine balloon inflated in the uterus) and is summarized in the Table . Median (range) maternal age was 33 years (19–47 years); 15 women (29%) were primigravid; 12 pregnancies (24%) were twin gestations; the estimated median gestational age at delivery was 38.4 weeks (22.0-42.0 weeks), and 23 pregnancies (45%) were delivered by cesarean section. The most common causes of PPH were uterine atony (73%) and abnormal placentation (33%); some women had multiple causes. Uterotonic agents were used in 50 cases (98%), with 46 women (90%) requiring ≥2 agents. Specific agents that were used included oxytocin for 47 women (94%), misoprostol for 42 women (84%), carboprost for 36 women (72%), and methylergonovine for 22 women (44%). Before BD-OTS insertion, 18 women (35%) underwent surgical interventions that included occlusive suture (n = 1), surgical repair (n = 2), uterine artery embolization (n = 1), and other (n = 15), which predominantly constituted uterine curettage.

The median (range) time interval between delivery and balloon insertion was 2.2 hours (0.3–210 hours). Insertion under ultrasound guidance was performed in 42 of 51 cases (82%). The vaginal balloon was inflated in 46 cases (90%). The median fill volumes for the uterine balloon and vaginal balloon were 500 mL (180-800 mL) and 200 mL (100-400 mL), respectively. Uterine fill volume was <500 mL in 15 cases (30%), 500 mL in 13 cases (25%), and >500 mL in 23 cases (45%). Median duration of use was 20.3 hours (0.3-35 hours).

After resolution of the PPH, the clinical investigators were asked by the study coordinator whether, at the clinically optimal balloon volume, did bleeding increase, not change, decrease, or stop? The investigators judged bleeding to be decreased in 22 cases (43%), stopped in 28 cases (55%), and thus decreased or stopped in 50 cases (98%). The clinical investigators were able to monitor for ongoing bleeding by way of the drainage port located above the uterine balloon. After placement of the BD-OTS, 8 patients underwent surgical interventions that included hysterectomy (n = 4), surgical repair (n = 3), and uterine artery embolization (n = 4); some patients had multiple surgical procedures. Median estimated blood loss was 2000 mL (855-8700 mL); 39 women (77%) received packed red blood cell transfusion of a median of 3 units (1-17 units). Intensive care unit admission was required in 12 cases (24%).

No serious adverse events that potentially were attributable to the BD-OTS were reported. One uterine rupture was reported, but this event was not attributed by the clinical investigator to the BD-OTS because it was judged most likely to have been present before the use of the BD-OTS; furthermore, the BD-OTS was placed after unsuccessful placement of another commercially available tamponade balloon.

We also looked at demographic and outcome variables ( Table ) in the 4 subpopulations of our cohort: uterine atony alone (n = 28), abnormal placentation alone (n = 8), both uterine atony and abnormal placentation (n = 9), and neither uterine atony nor abnormal placentation (n = 6). The abnormal placentation group consisted of retained placenta, placenta previa, and placenta accreta. The “neither uterine atony nor abnormal placentation” group included several cases of genital tract lacerations, which we suspect was composed primarily of undocumented cases of uterine atony or abnormal placentation. Although group size was small for the latter 3 groups (which precluded meaningful statistical analysis), it is worth noting that the combination of uterine atony and abnormal placentation appears to be associated more with primigravidity, twins, a longer time interval between delivery and balloon insertion, a longer duration of balloon use, and a higher number of surgical procedures before balloon placement.