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F. A. TARAN*, C. M. C. TEMPANY†, L. REGAN‡, Y. INBAR§, A. REVEL¶ and E. A. STEWART**

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Magnetic Resonance-guided Focused Ultrasound (MRgFUS) compared with Abdominal Hysterectomy for treatment of Uterine leiomyomas Journal of Ultrasound Obstetrics and Gynecology 2009; Volume34: 572–578. F. A. TARAN*, C. M. C. TEMPANY†, L. REGAN‡, Y. INBAR§, A. REVEL¶ and E. A. STEWART** - PowerPoint PPT Presentation

Text of F. A. TARAN*, C. M. C. TEMPANY†, L. REGAN‡, Y. INBAR§, A. REVEL¶ and E. A....

  • Magnetic Resonance-guided Focused Ultrasound (MRgFUS)compared with Abdominal Hysterectomy for treatmentof Uterine leiomyomasJournal of Ultrasound Obstetrics and Gynecology 2009; Volume34: 572578F. A. TARAN*, C. M. C. TEMPANY, L. REGAN, Y. INBAR, A. REVELand E. A. STEWART**

    *OB-GYN Dept, Mayo Clinic, Rochester, MN and Dept of Radiology and **Depts ofOB-GYN and Reproductive Biology, Brigham and Womens Hospital and Harvard Medical School, Boston, MA, USA,Dept of OB-GYN, St. Marys Hospital, London, UK and Dept of Radiology, Sheba Medical Center, Tel-Hashomer and Dept of OB-GYN, Hadassah Medical Center, Jerusalem, Israel

  • Definition of TermsMagnetic Resonance-guided Focused Ultrasound (MRgFUS) - A noninvasive, outpatient, surgical procedure that uses high intensity focused ultrasound waves to destroy tissue in combination with Magnetic Resonance Imaging (MRI), which guides and monitors the treatment- Approved by the US FDAin 2004

    http://www.focusedultrasound/for_clinicians/mrgfus.php

  • Definition of TermsUterine leiomyomas- Benign myometrial neoplams, very common- Frequently found in women between the ages 30-45- Represent the primary indication for hysterectomy in the United Stateshttp://en.wikipedia.org/wiki/Leiomyoma

  • Objective of the StudyTo compare women undergoing magnetic resonance-guided focused ultrasound (MRgFUS) to a group of women undergoing total abdominal hysterectomy based on patient demographics, safety parameters, quality of life outcomes, and disability measure.

  • MethodologyStudy was conducted in 14 medical centers in the United States, Israel, the UK, and GermanyPre-menopausal women with symptomatic fibroids were recruited for MRgFUS or hysterectomy

  • Methodology109 women underwent MRgFUS at 7 sites

    Brigham and Womens Hospital, Boston, MA (n = 24)Sheba Medical Center, Tel-Hashomer, Israel (n = 20)St. Marys Hospital, London (n = 19)Johns Hopkins Hospital, Baltimore, MD (n = 16)Mayo Clinic, Rochester, MN (n = 12)Charite Hospital, Berlin (n = 9)Hadassah Medical Center, Jerusalem, Israel (n = 9)

  • Methodology83 women underwent hysterectomy at 7 sites

    University of Texas Southwestern, Dallas, TX (n = 35) HaEmek Medical Center, Afula, Israel (n = 20)William Beaumont Hospital, Royal Oak, MI (n = 16)John Radcliffe Hospital, Oxford, UK (n = 6)Texas Institute of Clinical Research,Ft Worth,TX (n = 3) Wayne State University, Detroit, MI (n = 2) Frauenklinik Universitatsklinikum Benjamin Franklin, Berlin (n = 1)

  • MethodologyInclusion criteriaPre-menopausal womenSymptomatic uterine fibroidsAt least 18 years oldDo not want children in the future

  • MethodologyExclusion criteriaUterus larger than 24 weeks gestational sizeHematocrit
  • MethodologySymptom assessment used the Uterine Fibroid Symptom and Quality of Life Questionnaire (UFS-QOL)- validated disease-specific instrument- 8 item Symptom Severity Scale (SSS) and 6 dimensions of health-related quality of life (HRQL)- raw SSS of at least 21/40 required

  • MethodologyIn addition, the Short Form-36 health survey questionnaire was administered to provide an additional method of assessment of HRQL at baseline, and at months 1, 3, and 6 of follow-up

  • Study ProceduresMRgFUS treatment was based on leiomyoma size, symptomatology, and accessibility of the fibroid to the FUS beamAbdominal hysterectomy was performed based on the physicians standard of care

  • Outcome MeasuresSignificant clinical complications:

    Fever >38C on any 2 post treatment daysBlood transfusionUnintended major surgical procedureDischarge to a rehabilitation facilityDischarge with an appliance (drain, catheter)Outpatient interventional treatmentRehospitalizationLife-threatening eventDeath within 42 days of treatment

  • Statistical AnalysisAll data were entered into an internet-based database designed by ClickFindData entry application has a robust audit trail and data were verified before analysisData were then exported on a spreadsheet for transfer to SAS statistical software for analysis

  • Statistical AnalysisComparison between groups were conducted using chi-square tests for categorical variables, and t-tests for continuous variables For the significant clinical complications analysis, Fishers exact test was used All tests were two-tailedP < 0.05 considered statistically significant

  • Objective of the StudyTo compare women undergoing magnetic resonance-guided focused ultrasound (MRgFUS) to a group of women undergoing total abdominal hysterectomy based on patient demographics, safety parameters, quality of life outcomes, and disability measure.

  • Baseline Patient Characteristics of Treatment groups

  • ResultsStudy population was typical of premenopausal women with symptomatic fibroids, with most women being in their forties and having an increased body mass index (BMI). Women in the hysterectomy group were less likely to be Caucasian (54 vs. 80%; P < 0.001) and had higher BMI on average (29.9 6.0 vs. 25.8 5.2 kg/m2; P = 0.001)

  • ResultsBoth groups had significant levels of fibroid symptomatology and health-related impairment of quality of life at baseline, although the hysterectomy group had higher levels of symptoms Women undergoing hysterectomy had significantly worse function on several subsections of the SF-36 questionnaire including physical functioning, bodily pain, vitality, emotional role and mental health

  • Summary of Significant Clinical Complication Events

  • ResultsThere were fewer SCCs occurring in the MRgFUS group (14 events vs. 33 events; P < 0.0001) The rate fever was much lower in the MRgFUS group (3 events vs. 12 events; P = 0.005) Unintended surgical procedures related to treatment (removal of foreign body from the bladder, surgical repair of hernia, revision of enterotomy and surgical repair of an iatrogenic colonic lesion) were performed in four (5%) women from the hysterectomy groupThere were no deaths or life-threatening events in either group

  • Summary of Adverse and Serious Events

  • ResultsAt least one adverse event was reported by 88 (81%) women from the MRgFUS group and by 82 (99%) women from the hysterectomy group (P < 0.0001)Adverse events related to pain or discomfort, the gastrointestinal tract, dermatological conditions and nervous system were reported significantly less frequently by women from the MRgFUS group

  • Health Survey and Disability Assessment scores at Months 1,3,6

  • Health Survey and Disability Assessment scores at Months 1,3,6

  • Health Survey and Disability Assessment scores at Months 1,3,6

  • ResultsAt 1 month, women from the MRgFUS group had significantly greater improvement scores for the physical-function, physical-role and social-function components At 3 and 6 months these differences were not significant

  • ResultsDisability was supported by data on return to normal activitiesAt 1 month, women undergoing MRgFUS reported 1.2 lost working days and 2.7 days kept from usual activities compared with 19.2 and 17.4, respectively, for women undergoing hysterectomy (P < 0.0001)

  • ConclusionThe results of this study show that MRgFUS treatment of uterine leiomyomas leads to clinical improvement with fewer significant clinical complications and adverse events compared to hysterectomy during the 6-month follow-up

    Furthermore, MRgFUS treatment was associated with significantly faster recovery, including resumption of usual activities

  • Critical AppraisalClinical ScenarioHow does magnetic resonance-guided focused ultrasound (MRgFUS) compare as treatment for uterine leiomyomas with total abdominal hysterectomy based on patient demographics, safety parameters, quality of life outcomes, and disability measure?

  • RelevanceIs the objective of the article similar to your clinical dilemma?Yes, the objective is to compare a newer technique (MRgFUS) for Uterine leiomyoma treatment to the more classic Hysterectomy in terms of different outcomes. Our clinical dilemma is to determine if non-invasive techniques (MRgFUS) could be as effective as invasive techniques like surgery (Hysterectomy)

  • Was there a representative sample of patients without the outcome at the start of the observation?Yes, this was described in the Inclusion and Exclusion criteria in selecting the population for the study. Was follow up sufficiently long and complete? Yes, participants were followed up after 1 month, 3 months, and 6 months after treatment.

  • Was there adjustment for other prognostic factors?- YES. All models were adjusted for race and age, and models predicting infertility, pregnancy, and live birth were additionally adjusted for self reported infertility at baseline.

  • Were the criteria for determining the prognostic factor and outcome explicit and credible?

    Yes, all outcomes were assessed with validated toolsTools that were used were the following:Uterine Fibroid Symptom and Quality-of-Life Questionnaire (UFS-QOL) which consists of an eight-item Symptom Severity Scale (SSS) and six dimensions of health-related quality of life (HRQL)Short Form-36 health survey questionnaire

  • Overall, is the study valid?Yes, all the validity questions were fulfilled. The study was conducted in 14 medical centers in the United States, Israel, the UK and Germany.

    Can the results help me in caring for my patient?Yes, being given data of a study that compares two different treatments for uterine leiomyomas based on various outcomes gives us the option of selecting non-invasive techniques without compromising the effectiveness of the treatment, and the safety and quality of life of our patients

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