Global ablation device
ThermaChoice (n = 137)
Her Option (n = 193)
HTA (n = 187)
NovaSure (n = 175)
MEA (n = 215)
Protocol differences and exclusion criteria
Maximum sound length (cm)
10
10
10.5
10
14
Inclusion of polyps
No
No
No
Yes (<2 cm)
Yes
Inclusion of submucosal fibroids
No
No
No
Yes (<2 cm)
Yes (<3 cm)
Inclusion of distorted cavities
No
No
No
No
Yes
Congenital malformations
No
No
No
No
Yes
Endometrial pretreatment
D&C
Lupron 3.75 mg
Lupron 7.5 mg
None
Lupron 3.75 mg
Gynecologic history
Age (years)
40.4 (±4.8)
41.2 (±5.1)
40.7 (±5.2)
39.7 (±5.5)
40.5 (±4.6)
BMI
29.1 (±7.8)
29.3 (±8.4)
29.0 (±7.4)
27.6 (±6.3)
27.94 (±7.1)
Number of pregnancies
ND
2.5 (±1.2)
ND
2.7 (±1.3)
ND
Number of term deliveries
ND
2.4 (±1.2)
ND
2.2 (±1.1)
ND
Baseline diary score
552.5 (±712.2)
570 (±441)
596.55 (±787.6)
562 (±381)
451.8 (±356.6)
Uterine sounding length (cm)
8.5 (±1.3)
8.0 (±1.1)
8.3 (±1.3)
8.8 (±0.8)
8.09 (±1.0)
FDA-Approved GEA Methods
Some preoperative considerations before embarking on GEA include need for endometrial thinning, cervical dilation, prophylactic antibiotics, analgesia and/or sedation pre-procedure. Most of the FDA trials for the second-generation GEA devices used endometrial thinning pre-procedure with either a gonadotropin-releasing hormone (GnRH) agonist (i.e., goserelin) or dilation and curettage. The simplest option to ensure a thin endometrial lining pre-procedure is to schedule the procedure shortly after menstruation in the early proliferate phase of the menstrual cycle. Pharmacologic options for endometrial thinning include GnRH agonists; goserelin acetate (Zoladex®) being the most widely studied and associated with the best outcomes as well as FDA approval for this indication. Danazol, oral contraceptive pills (OCP) and medroxyprogesterone acetate injection may also be used to thin or stabilize the endometrium in the weeks prior to the procedure. Some form of endometrial thinning is advised pre-procedure, as it is associated with greater ease of procedure, fewer short-term complications, greater endometrial atrophy, and better overall outcomes post-procedure [11, 17].
Cervical ripening with misoprostol, orally or vaginally, may also be advisable for selected patients with cervical stenosis or those who are nulliparous or perimenopausal. Administration of misoprostol may limit patient discomfort and decrease the incidence of cervical injury during the procedure, but these benefits should be weighed against potential side effects such as uterine cramping and bleeding. In addition, the potential for increased transcervcial leakage of fluid if the HTA system is used should be managed, and patients should be counseled accordingly. Prophylactic antibiotics are not recommended for GEA procedures and the rate of post-procedure endometritis is very low. It is therefore up to the clinician’s judgment in using antibiotics if an individual patient is perceived to be at increased risk for infection (i.e., history of acute or chronic endometritis, vaginitis, gonoccocal or chlamydial infection) [9, 10, 16].
As part of the procedural analgesia and anesthesia protocol, patients are often pretreated with an oral analgesic and/or anxiolytic prior to the procedure. Detailed instructions include thorough pre-procedure counseling on what to expect, local anesthesia and analgesics, use of heating pads/warm packs and soothing background music. A dedicated support person is recommended for transportation post procedure.
The choice of the specific GEA modality to be used is based on many factors. Availability of different systems at a given facility, provider preference, and/or specific patient history and characteristics may make one modality superior over another (i.e., presence of intracavitary leiomyoma). The five currently FDA-approved second-generation GEA systems are as follows (see Table 10.2) [11].
Table 10.2
Non-resectoscopic endometrial ablation device comparisons
Method | Pretreatment | Outside diameter (mm) | Approximate treatment time (min) | Sounded uterine length (cm)a | Treatment in the presence of submucosal leiomyomata | ||||
---|---|---|---|---|---|---|---|---|---|
Published evidence | Type | Diameter (cm) | US Food and Drug Administration Approval | ||||||
Minimum | Maximum | ||||||||
ThermaChoice (thermal balloon) | Mechanical (suction aspiration) | 5.5 | 8 | 4 | 10 | Yes (Level I) | II | Smaller than or equal to 3 | No |
Her Option (cryotherapy) | Gonadotropin-releasing hormone agonist | 4.5 | 10–18 | Not specified | 10 | None | Not applicable | Not applicable | No |
Hydro ThermAblator (heated free fluid) | Gonadotropin-releasing hormone agonist | 7.8 | 14 | 4 | 10.5 | Yes (Level II-3) | Ib, II | Not specified | No |
Microwave endometrial ablation system (microwave energy) | Gonadotropin-releasing hormone agonist | 8.5 | 2.5–4.5 | 6 | 14 | Yes (Level I) | Ib, II | Smaller than or equal to 3 | Yes |
NovaSure (radiofrequency electricity) | None | 7.2 | 1–2 | 6 | 10 | Yes (Level II-2) | I, II | Smaller than or equal to 3 | No |
NovaSure®
The NovaSure endometrial ablation device is bipolar, single-use mesh electrode that utilizes radiofrequency energy to vaporize and coagulate the endometrium with simultaneous suction that pulls endometrial tissue into contact with the device while evacuating debris and steam generated by vaporization. Power delivery is calculated automatically based on measurements by the sounding device of the uterine cavity width and length, and the system includes an automatic safety feature based on carbon dioxide insufflation pressure that helps detect uterine perforation. The ablation portion of the procedure takes approximately 80–90 s. The NovaSure system has been used to perform office GEA throughout the United States with both IV and non-IV sedation with good outcomes [10, 16].