NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE INTERVENTIONAL PROCEDURES PROGRAMME Interventional procedures overview of free fluid thermal endometrial ablation
Introduction This overview has been prepared to assist members of the Interventional Procedures Advisory Committee advise on the safety and efficacy of an interventional procedure previously reviewed by SERNIP. It is based on a rapid survey of published literature, review of the procedure by Specialist Advisors and review of the content of the SERNIP file. It should not be regarded as a definitive assessment of the procedure. The evidence presented in this overview refers to one specific device used for the procedure, the HydroThermAblator system (Boston Scientific).
Date prepared This overview was prepared in November 2002.
Procedure names •
Free fluid thermal endometrial ablation
Specialty societies •
Royal College of Obstetricians and Gynaecologists.
Description Indications Heavy menstrual periods, also known as menorrhagia Menorrhagia is a very common problem. No routine data were found on the numbers of gynaecological procedures carried out each year in the UK by indication. In 2000/2001, about 45,000 hysterectomies and 17,000 therapeutic endoscopic uterine procedures were carried out in England (Hospital Episode Statistics; ungrossed for missing data; Department of Health). About half of these are likely to be for heavy menstrual bleeding.1 Summary of procedure Hysterectomy has been the traditional treatment for women with menorrhagia that has not responded to medical treatment. Minimally invasive procedures to destroy the lining of the uterus (endometrium) may reduce complications and recovery time compared with hysterectomy. These include hysteroscopic procedures, which involve destroying the endometrium with lasers, radiofrequency waves or electrocautery; and non-hysteroscopic procedures, which involve destroying the endometrium using heated saline, a heated balloon, lasers, or microwaves.
Free fluid thermal endometrial ablation
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Free fluid thermal endometrial ablation involves the instillation of circulating hot saline solution, into the uterus under hysteroscopic visualisation. The saline is heated to 90oC and circulated for 10 minutes.
Literature review Appraisal criteria Studies on free fluid thermal endometrial ablation for women with menorrhagia were included.
List of studies found One Cochrane systematic review of endometrial destruction techniques was found.1 The systematic review concluded that women undergoing thermal ablation techniques had a similar reduction in bleeding and were as satisfied as women having hysteroscopic resection of the endometrium. Advantages of thermal ablation techniques were that general anaesthetic was not required, and the procedures were quicker and easier to perform. The systematic review did not come to any conclusions about the relative benefits and harms of the different thermal endometrial destruction techniques. The systematic review found one randomised controlled trial2, which has recently been updated to include a 3 year follow-up.3 One case series with historical controls was found.4 Three other case series were found.5-7
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Table 1 Summary of key efficacy and safety findings Study details
Goldrath M3 and Corson SL2 Randomised controlled trial 9 centres in USA 1996
Key efficacy findings
Key safety findings
Key reliability and validity issues
Reduction of bleeding to normal or less (using diary scores): • free fluid thermal ablation: 82% at 12 months, 94% (127/135) at 36 months • rollerball ablation: 85% at 12 months, 91% (62/68) at 36 months
Equipment failure: • free fluid thermal ablation: 7 women • rollerball ablation: not stated
Randomisation method: block stratified.
n = 276 • free fluid thermal ablation: n = 184 (177 complete treatments; 7 incomplete) • rollerball ablation: n = 85 After randomisation, 7 patients did not receive treatment
Amenorrhoea: • free fluid thermal ablation: 40% (66/167) at 12 months, 53% (72/135) at 36 months • rollerball ablation: 51% (42/83) at 12 months, 46% (31/68) at 36 months
Pre-treatment regimen: single injection depot leuprolide acetate
Patient satisfaction at 36 months: • free fluid thermal ablation: 98% • rollerball ablation: 97%
Inclusion criteria: • age 30–50 years • documentation of excessive bleeding • uterine cavity between 4 and 10.5 cm • no desire for future fertility Exclusion criteria: • active pelvic inflammatory disease • intramural fibroids > 4 cm • submucous fibroids or polyps Follow up: 36 months
Free fluid thermal endometrial ablation
Subsequent hysterectomy • free fluid thermal ablation: 9% (16/177) • rollerball ablation: 6% (5/85) Overall success after 36 months: women with normal bleeding or less without repeat ablations, hysterectomies, or other interventional procedures • free fluid thermal ablation: 81.4% (127/156) • rollerball ablation: 81.6% (62/76)
Free fluid thermal ablation complications at 12 months2: • nausea/vomiting: 22% • first-degree burns on buttocks or upper thigh: 2 women • endometritis: 2 women • urinary tract infection: 5 women • haematometra: 2 women At 36 months3 : • burns on buttocks or upper thigh: 1.1% (2/177) • endometritis: 1.1% (2/177) • urinary tract infection: 2.7% (5/177) • haematometra: 1.1% (2/177) Rollerball complications at 12 months2:: • nausea/vomiting: 7% • cervical lacerations: 1 women • endometritis: 1 woman • urinary tract infection: 2 women haematometra: 5 women At 36 months3 :: • cervical lacerations: 2.4% (2/85) (1 developed septicaemia) • endometritis: 1.2% (1/85) • urinary tract infection: 2.4% (2/85) • haematometra: 5.9% (5/85)
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Analysis done by per protocol rather than by intention to treat. No major differences in characteristics between free fluid thermal ablation and rollerball ablation groups. Power reasonable. Blinding not described. Losses to follow up: • free fluid thermal ablation: 5.6% (10/177) women at 12 months, 23.7% (42/177) women at 36 months • rollerball ablation: 2.4% (2/85) women at 12 months, 20% (17/85) women at 36 months Funded by makers of the free fluid thermal system).
Summary of key efficacy and safety findings (2) Study details
Key efficacy findings
Key safety findings
Key reliability and validity issues
‘No intraoperative complications’
Case series with historical controls.
Lodi, Italy
At 24 months, ‘control of menorrhagia’ • free fluid thermal ablation: 82% • thermal balloon ablation: 74% P = 0.4
Thermal balloon ablation complications: • pain requiring analgesics: 14 women • pain requiring narcotics: 2 women • endometritis: 1 woman
Women were all morbidly obese; body mass index > 36.
Garuti G4 Case series with historical controls
1994 to 1999 n = 40 • free fluid thermal ablation; n = 17; mean age 45 years; treated from 1998 to 1999 • thermal balloon ablation; n = 23; mean age 43 years ; treated from 1994 to 1997
At 24 months, amenorrhoea: • free fluid thermal ablation: 3 women • thermal balloon ablation: 1 woman P = ‘not significant’
Free fluid thermal ablation complications pain requiring treatment: none
Outcome assessment not described.
Uncontrolled, small case series.
Subsequent procedure: • free fluid thermal ablation: 3 • thermal balloon ablation: 6
Follow up • free fluid thermal ablation: 24 months • thermal balloon ablation: 48 months Weisberg M5
Amenorrhoea: 10/18 women
‘No intraoperative complications’
Case series
Menorrhagia: 1/18 women
Cramping requiring analgesics: 3 women
Philadelphia, USA
Subsequent hysterectomy: 1/18 women
Serosanguinous vaginal discharge in ‘most’ patients for about 2 weeks
1997 n = 20 mean age 43 years Follow up: 12 months
Free fluid thermal endometrial ablation
Body mass index higher in free fluid thermal ablation patients, by 4 kg/m2.
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Study details Romer T6
Key efficacy findings
Key safety findings
Key reliability and validity issues
Reduced menstrual flow: 17/18 women Amenorrhoea: 9 women
Complications not reported in abstract
German paper: limited information available from English abstract.
Case series Small uncontrolled case series. Cologne, Germany Date not stated (published 1999) N = 18 [age?] Follow up: 12 months Perlitz Y7
Amenorrhoea: 11/13
Case series
Hysterectomy: 1/13
Haifa, Israel
Repeat free fluid thermal ablation: 1 patient
Complications: • technical failure requiring conversion to rollerball ablation: 1 woman • no other complications occurred
Date not stated (published 2001) N = 14 mean age 43 years Follow up: 9–18 months
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Uncontrolled small case series.. Methods of assessing outcome measures not described.
Validity and generalisability of the studies •
All the studies were carried out in settings appropriate to the UK.
•
The randomised controlled trial was of moderate quality.2,3 Outcome assessment was not blinded and analysis was not done by intention to treat. It was funded by the manufacturers of the HydroThermAblator system.
•
One case series was found with historical controls.4 It was very small and any differences in outcome are likely to be confounded by baseline characteristics and period of operation.
•
The other three case series were very small.5-7
•
Additional scrutiny of the literature was conducted because of the uncertainty about the risk of this procedure causing burns.8-11 In total, four patients with burns were found. Corson reports two patients, one with burns on the upper thigh and one on the buttock, both arising from “prolonged contact with tubing connecting the control unit to the inflow channel of the hysteroscopic sheath”.2 Romer et al report two patients who had vaginal burns: one by hot water and one by the sheath.10 These burns arose from a total of 543 patients in the literature reviewed, a rate of 0.74%.
Specialist advisors’ opinions Specialist advice was sought from the Royal College of Obstetricians and Gynaecologists. • •
Uptake of the procedure has been low. Perineal burns may be severe.
Issues for consideration by IPAC •
None other than those discussed above.
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References 1. Lethaby A, Hickey M Endometrial destruction techniques for heavy menstrual bleeding (Cochrane Review). In: The Cochrane Library, Issue 4, 2002. Oxford: Update Software. 2. Corson SL. A multicenter evaluation of endometrial ablation by Hydro ThermAblator and rollerball for treatment of menorrhagia. Journal of the American Association of Gynecologic Laparoscopists 2001; 8: 359–67. 3. Goldrath MH. Evaluation of HydroThermAblator and rollerball endometrial ablation for menorrhagia 3 years after treatment. Journal of the American Association of Gynecologic Laparoscopists 2003; 10: 505–11. 4. Garuti G, Cellani F, Colonnelli M, Luerti M. Endometrial thermal ablation to treat dysfunctional menorrhagia; a clinical experience using two different techniques. Italian Journal of Gynaecology & Obstetrics 2001; 13: 160–5. 5. Weisberg M, Goldrath MH, Berman J, Greenstein A, et al. Hysteroscopic endometrial ablation using free heated saline for the treatment of menorrhagia. Journal of the American Association of Gynecologic Laparoscopists 2000; 7: 311–6. 6. Romer T, Muller J. Hydrothermal ablation of the endometrium in patients with recurrent menorrhagia: Early experience. Geburtshilfe und Frauenheilkunde 1999; 59: 475–8. 7. Perlitz Y, Rahav D, Ben Ami M. Endometrial ablation using hysteroscopic instillation of hot saline solution into the uterus. European Journal of Obstetrics, Gynecology, & Reproductive Biology 2001; 99: 90–2. 8. das Dores GB, Richart RM, Nicolau SM, Focchia GR, et al. Evaluation of hydro thermAblator for endometrial destruction in patients with menorrhagia. Journal of the American Association of Gynecologic Laparoscopists 1999; 6: 275–8. 9. Romer T, Muller J. A simple method of coagulating endometrium in patients with therapy-resistant, recurring hypermenorrhea. Journal of the American Association of Gynecologic Laparoscopists 1999; 6: 265–86. 10. Romer T, Muller J, Foth D. Hydrothermal ablation: a new simple method for coagulating endometrium in patients with therapy-resistant recurring hypermenorrhea. Contributions to Gynecology and Obstetrics 2000; 20: 154– 60. 11. Hefni MA, El-Toukhy T, Nagy C, Mahadevan S, et al. Hydrothermal ablation: assessment of a new simple method for treatment of uncontrolled menorrhagia. Gynaecological Endoscopy 2002; 11: 111–7. Original overview prepared by: Bazian Ltd November 2002
Overview amended by NICE to include details of burns. Further amended by NICE to include updated study, January 2004.
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