INTERVENTIONAL PROCEDURES PROGRAMME

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1 NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE INTERVENTIONAL PROCEDURES PROGRAMME Interventional procedure overview of balloon thermal endometrial ablation (Cavaterm) Introduction This overview has been prepared to assist members of IPAC 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 one or more specialist advisor(s) and review of the content of the SERNIP file. It should not be regarded as a definitive assessment of the procedure. Procedure name Thermal endometrial ablation (Cavaterm) SERNIP procedure number 99 Specialty society Royal College of Obstetricians and Gynaecologists Indication(s) Heavy menstrual periods, also known as menorrhagia. Menorrhagia is a very common problem. We found no routine data 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. They involve destroying the endometrium with lasers, radiofrequency waves, electrocautery, heated saline, a heated balloon, or microwaves. Balloon thermal endometrial ablation is one of these minimally invasive procedures. Cavaterm thermal balloon endometrial ablation involves inserting a balloon into the uterine cavity through the cervix. The surgeon inflates the balloon with a glycine solution to a pressure of 180 to 220 mmhg. The solution is heated to 75ºC for 15 minutes to destroy the endometrium. It can often be carried out under local anaesthetic on a day-case basis. Cavaterm thermal endometrial ablation page 1 of 9

2 The claimed advantage of Cavaterm over Gynecare Thermachoice, another thermal balloon endometrial ablation system, is that the balloon size is adjustable to fit different sized uterine cavities. Literature review Appraisal criteria We only included studies on balloon thermal ablation using the Cavaterm procedure in women with menorrhagia. Studies where the technique was not specified were excluded. List of studies found We found one Cochrane systematic review of endometrial destruction techniques. 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 included one randomised controlled trial using Cavaterm. 2 We found two further randomised controlled trials. 3,4 We found nine case series. The table provides details of the three largest of these. 5-7 The annex provides references to smaller studies. Cavaterm thermal endometrial ablation page 2 of 9

3 Summary of key efficacy and safety findings (1) Authors, location, date, patients Key efficacy findings Key safety findings Key reliability and validity issues Romer T 2 No difference between Cavaterm and Complications not reported in English Randomised controlled trial Rollerball in satisfaction abstract or Cochrane review Germany Date not stated (published 1998) n=20, age 35 to 52 Cavaterm; n= 10 Rollerball ablation; n= 10 Follow up: 9 to 15 months Exclusion criteria: desire for future fertility fibroids intrauterine abnormality Romer T 3 Randomised controlled trial Germany Date not stated (published 1997) n=30 Cavaterm; n= 15 Rollerball; n= 15 Minimum follow up: 6 months Exclusion criteria: intrauterine abnormality No difference between Cavaterm and rollerball in amenorrhoea rate Amenorrhoea: Cavaterm: 33% Rollerball: 33% Reduction of menstrual flow: Cavaterm: 100% Rollerball: 100% No intra- or postoperative complications Report in German: data taken from English abstract and Cochrane systematic review 1 Randomisation method not Comparison of baseline data not Power very limited Follow up short Losses to follow up not Blinding not Abstract presented at conference; full report not found in peer-reviewed journal Randomisation method not Comparison of baseline data not Power very limited Follow up short Losses to follow up not Outcomes not defined Blinding not May be duplication of women from those in Romer T 2 Cavaterm thermal endometrial ablation page 3 of 9

4 Summary of key efficacy and safety findings (2) Authors, location, date, patients Key efficacy findings Key safety findings Key reliability and validity issues Pellicano M 4 Operation time: Cavaterm (number of women): Randomisation method: computergenerated Cavaterm: 24 minutes fever (1) random number sequence TCRE: 37 minutes haemorrhage (5) p<0.01 blood transfusion (2) Randomised controlled trial Italy 1998 to 1999 n=82 Cavaterm; n=40; mean age 43 Transcervical resection of endometrium (TCRE); n= 42; mean age 43 Follow up: 2 years Exclusion criteria: age >50 weight >100 kg abnormal endometrium or Pap smear uterine size >12 weeks pregnancy fibroids prolapse endometriosis urinary symptoms Return to normal activities Cavaterm: 4 days TCRE: 6 days p>0.05 Bleeding recurrence at 2 years (not further defined): Cavaterm: 8% TCRE: 24% p<0.01 Pain recurrence at 2 years: Cavaterm: 6% TCRE: 27% p<0.01 Satisfaction at 2 years excellent : Cavaterm: 46% TCRE: 6% p<0.001 Reoperation at 2 years Cavaterm:6% TCRE: % p<0.01 TCRE (number of women): fever (2) urinary infection or retention (1) haemorrhage (4) fluid overload (5) cervical tear (1) conversion to hysterectomy (2) No large differences between groups in baseline characteristics Blinding not Losses to follow up: Cavaterm: 5 women TCRE: 9 women Outcomes appropriate Cavaterm thermal endometrial ablation page 4 of 9

5 Summary of key efficacy and safety findings (3) Authors, location, date, patients Key efficacy findings Key safety findings Key reliability and validity issues Friberg B 5 Returned home on day of treatment: No immediate perioperative Uncontrolled case series 91/117 complications Case series Sweden 1993 to 1996 n=117, mean age 43 Mean follow up: 25 months, range 10 to 49 months Inclusion criteria: no desire for future fertility no genital malignancy Treatment successful in 94% Amenorrhoea: 30/102 Satisfaction excellent : 97/106 Subsequent hysterectomy: 10 women Complications: endometritis: 3 women abdominal pain and fever: 1 woman Outcomes appropriate Follow up variable length Short follow up for some women general anaesthesia (n=95) spinal anaesthesia (n=18) local paracervical block (n=4) Gerber J 6 Satisfaction good to excellent : 93% No complications occurred Uncontrolled case series Case series Switzerland Date not stated (published 1999) n=67 Follow up available on 55 women Amenorrhoea: 30% Hysterectomy: 3 women Paper in German; data extracted from English abstract Short follow up Follow up: > 6 months Cavaterm thermal endometrial ablation page 5 of 9

6 Summary of key efficacy and safety findings (4) Authors, location, date, patients Key efficacy findings Key safety findings Key reliability and validity issues Hawe J 7 Amenorrhoea: 34 women No major complications occurred Uncontrolled case series Spotting: 12 women Normal periods: 2 women Short follow up in some women Case series UK Date not stated (published 1999) n=50; mean age 45, range 28 to 54 Mean follow up: 14 months, range 6 to 24 months Exclusion criteria: desire for future fertility endometrial hyperplasia uterine cavity length >12 cm polyps or fibroids General anaesthesia (n=36) Sedation and paracervical block (n=14) Subsequent hysterectomy or laser ablation: 2 women Complications: streptococcal infection: 2 women unexplained right iliac fossa pain for 24 hours: 1 woman endometritis: 1 woman Methods of measuring outcomes not Cavaterm thermal endometrial ablation page 6 of 9

7 Validity and generalisability of the studies We found three randomised controlled trials. 2-4 Two may have included the same study participants. 2,3 Reports of these two trials were only available as abstracts, so it was difficult to assess quality. Both trials were very small and follow up was short. The third trial was of reasonable quality, though also small, and blinding of outcome assessment was not. 4 The first two trials 2,3 compared Cavaterm with Rollerball hysteroscopic ablation. The third trial compared Cavaterm with hysteroscopic resection. 4 We found three case series including 50 or more women. 5-7 Follow up was short for many of the included women. Bazian comments None Specialist advisor s opinion / advisors opinions Specialist advice was sought from the Royal College of Obstetricians and Gynaecologists Cavaterm is now established practice. It does not require hysteroscopic skills. Issues for consideration by IPAC None other than those above. Cavaterm thermal endometrial ablation page 7 of 9

8 References 1. Lethaby A, Hickey M Endometrial destruction techniques for heavy menstrual bleeding (Cochrane Review). In: The Cochrane Library, Issue 4, Oxford: Update Software 2. Romer T. Rollerball endometrial ablation - a prospective randomized comparative study [German]. Zentralblatt fur Gynakologie 1998; 120: Romer T, Muller J. Comparative prospective study of the treatment of recurrent menorrhagias: Cavaterm coagulation versus rollerball ablation. Gynaecological Endoscopy 1997; 6 (supplement 2): Pellicano M, Guida M, Acunzo G, Cirillo D, Bifulco G, Nappi C. Hysteroscopic transcervical endometrial resection versus thermal destruction for menorrhagia: A prospective randomized trial on satisfaction rate. American Journal of Obstetrics & Gynecology 2002; 187(3): Friberg B, Ahlgren M. Thermal balloon endometrial destruction: The outcome of treatment of 117 women followed up for a maximum period of 4 years. Gynaecological Endoscopy 2000; 9(6): Gerber S, Wirz C, Genolet PM, de Grandi P. Thermal endometrial destruction: clinical results of a new technique of endometrial ablation [German]. Journal fur Menopause 1999; 6: Hawe JA, Phillips AG, Chien PF, Erian J, Garry R. Cavaterm thermal balloon ablation for the treatment of menorrhagia. British Journal of Obstetrics & Gynaecology 1999; 106(11): Cavaterm thermal endometrial ablation page 8 of 9

9 Annex: References to smaller case series Reference Aletebi FA, Vilos GA, Eskandar MA. Thermal balloon endometrial ablation to treat menorrhagia in high-risk surgical candidates. Journal of the American Association of Gynecologic Laparoscopists 1999; 6(4): Friberg B, Persson BRR, Willen R, Ahlgren M. Endometrial destruction by thermal coagulation: Evaluation of a new form of treatment for menorrhagia. Gynaecological Endoscopy 1998; 7(2):73-78 Refaie AMN, Salim MS, Cheah SS, Anderson T. Is uterine thermal balloon ablation an effective treatment for menorrhagia? Middle East Fertility Society Journal 2001; 6(3): Vilos GA, Vilos EC, Pendley L. Endometrial ablation with a thermal balloon for the treatment of menorrhagia. Journal of the American Association of Gynecologic Laparoscopists 1996; 3(3): Singh KC, Sengupta R, Agarwal N, Misra K. Thermal endometrial ablation: A simple technique. Acta Obstetricia et Gynecologica Scandinavica 2000; 79(1):54-59 Friberg B, Persson BR, Willen R, Ahlgren M. Endometrial destruction by hyperthermia - a possible treatment of menorrhagia. An experimental study. Acta Obstetricia et Gynecologica Scandinavica 1996; 75(4): Number of study participants Overview prepared by: Bazian Ltd November 2002 Cavaterm thermal endometrial ablation page 9 of 9