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AJR 2007; 188:A78-A82
© American Roentgen Ray Society


ABSTRACT

26. Genitourinary (Renal Transport and GU Sonography)

Scientific Session 26—Genitourinary (Renal Transplant and GU Sonography)

Thursday, May 10, 1:30 PM–3:30 PM

Abstracts 261-272

Moderator(s): Vikram Dogra and Wui Chong

1:30 PM

261. Findings in Early and Late Postoperative MRI of Dysfunctional Renal Allografts

Weininger M.*; Lopau K.; Gerharz E.; Hahn D.; Beissert M. University Hospital of Wuerzburg, Wuerzburg, Germany

Address correspondence to M. Weininger (weininger{at}roentgen.uni-wuerzburg.de)

Objective: To evaluate different diagnoses in early and late postoperative MRI in renal transplant dysfunction and to conclusively define the most beneficial MRI protocols.

Materials and Methods: We reviewed 63 MRI studies of 42 renal transplant recipients (26 men, 16 women) with dysfunctional allografts. According to the date of examination all studies were divided in an early (= 60 days after transplantation) and a late post-transplant period (>60 postoperative days). All studies were performed on 1.5-T MR systems (Somatom, Siemens Erlangen) using a standardized protocol consisting of a morphological (pre- and postcontrast enhanced T1- and T2-weighted TSE sequences), a vascular (gadolinium-enhanced 3D MRA) and a urographical part (FLASH 3D sequence). Statistical analysis was performed using a binomial test, correlating early- and late-period diagnoses, and the diagnoses within each group.

Results: 37/63 MRI examinations were performed in the early postoperative period (EP), 26/63 in the late postoperative period (LP). Evaluating all 63 examinations 68 diagnoses were obtained: Renal artery stenosis (EP, n = 18; LP, n = 4), renal vein stenosis (EP, n = 2), renal vein thrombosis (EP, n = 2), renal perfusion defect (EP, n = 8), rejection (EP, n = 1; LP, n = 2), abscess (EP, n = 1), urinary outflow obstruction (LP, n = 4), malignancy (LP, n = 1), without MRI pathology (EP, n = 9; LP, n = 16). The following statistically significant allocations of diagnoses (p < 0.05) could be found: Renal artery stenosis was the most prevalent diagnosis in EP, and a more frequent finding in EP compared to LP; renal perfusion defects were more frequent in EP. Urinary outflow obstruction was only seen in LP but without statistical significance.

Conclusion: Dividing the clinical course after renal transplantation in an early and a late postoperative period is a valid differentiation as we could statistically prove by different sets of diagnoses for renal allograft dysfunction in each period. As a consequence an MRI in the early period should focus on a vascular examination protocol to diagnose renal artery stenosis and perfusion defects, whereas in the late period a urographical focus is of importance.

* Will present paper

1:40 PM

262. Contrast-enhanced Ultrasound with CPS in Characterization of Focal Renal Lesions Versus CT

Clevert D. A.2*; Michaely H.1; Strautz T.1; Flach P.2; Staehler M.2; Becker C.2; Reiser M.2 1. Department of Radiology, Munich, Germany; 2. Department of Urology, Munich, Germany

Address correspondence to D. Clevert (Dirk.Clevert{at}med.uni-muenchen.de)

Objective: To evaluate and compare the diagnostic accuracy of low-mechanical-index (low MI) contrast enhanced ultrasound (CUS) with CT and histological and operative findings in focal lesions of kidney.

Materials and Methods: Thirty-two patients with focal renal lesions depicted by ultrasound were prospectively examined with CUS in low MI-technique using 1.6 to 2.4 ml intravenous injection of SonoVue (Bracco, Italy) using a multifrequency transducer 2-4 MHz (Siemens, Sequoia, Acuson). The entire examination was saved as cine sequences. The contrast enhancement was examined in the arterial, venous, and late venous phase. The results were compared with CT. As gold standard histological findings were assessed.

Results: In all patients, contrast-enhanced US could be performed and perfusion pattern of the renal lesion could be diagnostically evaluated. Histological findings showed 22 solid renal cell carcinoma, 6 cystic lesions and 4 pseudotumors. Beside the different contrast patterns even smallest lesions could be depicted. In addition for pre-surgery planning the renal veins and inferior cava were examined.

Conclusion: CUS with SonoVue allows an early evaluation of smallest renal lesions. It is an additional examination to CT. Due to the dynamic examination additional information about tumor infiltration into the renal veins or inferior cava vein can be gained.

* Will present paper

1:50 PM

263. Percutaneous Interventions in Renal Transplant Complications

Lang E. K.1,2; Macchia R.3; Meisamy S.2; Thomas R.4; Colon I.3; Emery K.2 * 1. Johns Hopkins University, Baltimore, MD; 2. SUNY Downstate Medical Center, Department of Radiology Brooklyn, NY; 3. SUNY, Downstate Medical Center, Department of Urology, Brooklyn, NY; 4. Tulane Health Science Center, New Orleans, LA

Address correspondence to E. Lang (erich.lang{at}downstate.edu)

Objective: To establish contributions and indications for radiologic interventions in renal transplant complications.

Materials and Methods: 115 patients, 61 adult men, 41 adult women, and 12 pediatric age patients were treated for the following renal transplant l complications by interventional radiologic techniques: obstruction at the ureter-neocystostomy in the immediate postoperative period (N27), with a 5-month–4-year delay (N31), at uretero-Boari anastamosis (N2), Boari-pyelostomy (N1), lymphocyst (N18), urinoma (N13), postbiopsy bleed (N18), transplant artery anastomotic stricture (N7).

Results: Early obstruction likely caused by edema was abated by short term percutaneous nephrostomy drainage in 23 of 27 patients. Balloon dilatation, stenting, incision with cutting balloon corrected delayed obstructions at uretero-neocystostomies and uretero-Boari or calicostomies in only 6 of 36 patients; transcatheter embolization controlled bleeding in all 18 patients, percutaneous drainage (N13) in conjunction with stent placement (N6) urinomas in 12 of 13, balloon dilatation and stent placement arterial anastomotic stenoses in 5 of 7 and drainage in 12 of 18 lymphocysts.

Conclusion: Percutaneous nephrostomy is the treatment of choice for early obstruction at uretero-neocystostomies as is embolization of postbiopsy AV aneurysms and drainage sometimes combined with stenting of urinomas, as well as dilatation and stenting of anastomotic arterial anastomoses. However, surgical correction of delayed uretero-neocystostomy, Boari, or calicostomy anastomoses, likely cased by chronic rejection, has better success rate.

* Will present paper

2:00 PM

264. Sonographic Findings in Fournier's Gangrene

Chin B. M.*; Chong W. K.; Mittelstaedt C. A. University of North Carolina Hospitals, Chapel Hill, NC

Address correspondence to B. Chin (bchin{at}unch.unc.edu)

Objective: Fournier's gangrene is a rapidly progressive, necrotizing fasciitis involving the skin of the scrotum and perineum. It is associated with a high mortality and requires aggressive therapy. Patients complain of scrotal pain, swelling and tenderness to palpation, symptoms which may also be present with acute epididymitis or epididymo-orchitis. The purpose of this study is to identify ultrasound findings associated specifically with Fournier's gangrene.

Materials and Methods: Gray scale and Doppler ultrasound scans performed at time of presentation in 12 cases of surgically and pathologically proven Fournier's gangrene were retrospectively reviewed and compared to scans from a control group of patients with uncomplicated epididymo-orchitis. All patients were scanned using high frequency (8-15 MHz) linear transducers on state-of-the-art equipment using the same protocol. Gray scale, and Doppler images were obtained of the testes, scrotal sacs and scrotal wall with Doppler settings optimized for low flow.

Results: Patients with Fournier's gangrene showed thickening of the scrotal wall greater than 1 cm, while the scrotal wall was less than 1 cm thick in the non-Fournier's group. Complex hydroceles were found in both groups but fluid collections within the scrotal wall and scrotal wall air were seen in nine of the Fournier's patients but in none of the control group. Tracking of fluid within fascial planes, particularly within Dartos fascia, was characteristic of Fournier's gangrene. This was not seen in patients with epididymo-orchitis. Doppler ultrasound identified testicular abnormalities in half of the Fournier's patients. These abnormalities included testicular heterogeneity, asymmetric flow and testicular infarction.

Conclusion: Fluid and/or air within the scrotal wall along with wall thickening of greater than 1 cm in a patient with an acutely inflamed scrotum should raise the suspicion of Fournier's gangrene. Knowledge of specific Doppler US findings associated with Fournier's gangrene will enable the examiner to accurately diagnose this condition and to successfully distinguish it from other inflammatory conditions that are managed more conservatively.

* Will present paper

2:10 PM

265. The Value of Contrast-enhanced US in the Characterization of Cystic Renal Masses with a Complex Pattern at Baseline US: Analysis of Diagnostic Confidence

Quaia E.*; Rossi A.; Cos M.; Cova M. Department of Radiology, University of Trieste, Trieste, Italy

Address correspondence to E. Quaia (quaia{at}units.it)

Objective: The accurate characterization of complex cystic renal masses is among the most challenging problems in ultrasound (US). The aim of this study was to assess the gain in diagnostic confidence provided by contrast-enhanced US in those cystic renal masses presenting a complex pattern at baseline US.

Materials and Methods: A series of 23 renal masses <5 cm in diameter with a complex cystic pattern at baseline gray-scale US were incidentally identified in 23 consecutive patients (10 men and 13 women, age 65 ± 15 years) during US or contrast-enhanced CT scanning performed during routine clinical diagnostic work-up. The complex pattern at baseline US consisted in intracystic septa or peripheral mural nodules with vascular signals at color Doppler US (n = 15), or in a mixed solid and cystic pattern (n = 4) or corpuscolar echoic pattern (n = 4) at baseline gray-scale US. Each renal mass was scanned by contrast-enhanced US after sulfur hexafluoride-filled microbubble i.v. injection during arterial (15-40 secs) and late phase (40-120 secs from injection). The distribution of contrast enhancement in the cystic renal masses was assessed by 2 on-site sonologists in consensus. Off-site review of baseline and contrast-enhanced US scans was performed by 2 independent blinded readers not involved in scanning who expressed a benign or malignant diagnosis according to established diagnostic criteria. Histology (n = 20) or cross-sectional imaging (n = 3) with 6 months-1 year follow-up were considered as the reference standards for the definitive characterization.

Results: Final diagnoses comprised 15 cystic renal cell carcinomas, 2 multilocular cystic nephromas, 2 inflammatory, and 4 hemorrhagic cysts. Cystic renal cell carcinomas revealed peripheral enhancement in the wall (n = 3) or mural nodules (n = 3) or diffuse enhancement involving the wall, mural nodules, and intracystic septa (n = 9). Benign cystic renal masses revealed peripheral wall enhancement (multilocular cystic nephromas and inflammatory cysts) or absent contrast enhancement (hemorrhagic cysts). The overall diagnostic confidence in malignancy diagnosis improved significantly (p < 0.05) after microbubble injection (area under ROC curve reader 1/reader 2: 0.702/0.688 for baseline US, 0.922/0.931 for contrast-enhanced US).

Conclusion: Contrast-enhanced US improved the overall diagnostic confidence in the characterization of complex cystic renal masses identified at baseline US, and could be proposed in the routine scanning of complex cystic renal masses.

* Will present paper

2:20 PM

266. Sonography of Uterine Abnormalities in Postpartum and Postabortion Patients: A Potential Pitfall of Interpretation

Rufener S.*; Adusumilli S.; Weadock W.; Caoili E.; Schipper M. University of Michigan, Ann Arbor, MI

Address correspondence to S. Rufener (srufener{at}med.umich.edu)

Objective: The interpretation of postpartum and postabortion uterine abnormalities on ultrasound can be challenging. Certain imaging features can influence the radiologist to include entities such as uterine arteriovenous malformation (AVM) in the differential diagnosis which can alter patient management. The purpose of this study was to evaluate interobserver agreement in characterizing uterine abnormalities on ultrasound and to identify imaging features that lead to inclusion of uterine AVM in the differential diagnosis of a vascular uterine mass.

Materials and Methods: The ultrasounds of 29 pathologically proven cases of uterine abnormalities in postpartum and postabortion patients were retrospectively reviewed. Two radiologists independently evaluated the following features: presence of a uterine mass, endometrial or myometrial location of mass, and presence of an associated vascular abnormality. Frequency tables were created to evaluate for percent agreement between the two radiologists. Fisher's exact chi-squared test was performed to evaluate the relationship between imaging features and inclusion of uterine AVM in the differential diagnosis.

Results: Percent agreement for presence of a uterine mass was 90%, location of mass was 83%, presence of an associated vascular abnormality was 72%, and inclusion of uterine AVM in the differential diagnosis was 86%. Myometrial location showed the most significant relationship to inclusion of uterine AVM in the differential diagnosis with p = 0.034 and p = 0.00005 for each radiologist, respectively. Final pathologic diagnoses included retained products of conception (RPOC) (n = 26), endometrial polyp (n = 1), chronic endometritis (n = 1), and exogenous progestational effect (n = 1).

Conclusion: Despite high interobserver agreement in characterizing postpartum and postabortion uterine abnormalities on ultrasound, readers still include uterine AVM in the differential diagnosis of uterine masses that are ultimately proven to be RPOC. Myometrial location of a uterine mass is a particularly misleading imaging feature of RPOC. In these instances, noninvasive imaging may be helpful in excluding a uterine AVM which is a very rare entity.

* Will present paper

2:30 PM

267. Reliability of the "Intradecidual Sign" as Evidence of Intrauterine Pregnancy

Petscavage J.*; Wachsberg R. New Jersey Medical School, Newark, NJ

Address correspondence to J. Petscavage (wachsbrh{at}umdnj.edu)

Objective: To evaluate the predictive value of the "intradecidual sign" (IDS) as a transvaginal sonographic indicator of intrauterine pregnancy. The literature reveals controversy regarding the specificity of the IDS.

Materials and Methods: We reviewed sonographic records for the past four years, and identified all cases in which transvaginal sonography revealed the IDS during early pregnancy. The IDS was deemed present if sonography revealed a nonchanging spherical cystic structure with a variably thick wall, located within the endometrial stripe, adjacent to but clearly distinct from the central echogenic line corresponding to the uterine cavity. Medical records of patients in whom the IDS was identified were reviewed to determine if follow-up revealed whether the pregnancy was intrauterine or extrauterine. Those patients with satisfactory follow-up constitute the study group.

Results: The IDS was present in 28 pregnant women with follow-up. Intrauterine pregnancy was subsequently confirmed in all cases.

Conclusion: When diagnostic criteria for the IDS are strictly adhered to, this sign is reliable evidence of intrauterine pregnancy.

* Will present paper

2:40 PM

268. Testicular Tumor and Testicular Microlithiasis: Doppler US Approach

Serter S.1*; Orguc S.1; Tuncyurek O.1; Gümü B.1; Tarhan S.1; Ayyildiz V.2; Pabuscu Y.1 1. Celal Bayar University, Manisa, Turkey; 2. Manisa Military Hospital, Manisa, Turkey

Address correspondence to S. Serter (serterselim{at}gmail.com)

Objective: The aim of this prospective study is to compare the resistive index (RI) values, which is a parameter of testicular parenchymal perfusion in testicular microlithiasis (TM) and normal cases and thus to evaluate the hypothesis of increased local pressure in the testicular parenchyma due to the compression of microliths and the possible effect of microliths in tumor formation.

Materials and Methods: Healthy men 17-42 years old 2,179 volunteers from the annual army Reserve Officer Training Corps training camp were included the study. A screening scrotal ultrasound was performed. All men diagnosed with testicular microlithiasis underwent scrotal Doppler ultrasound (DU). DU was performed for subjects with TM and RI was determined. DU was also performed subjects without TM for control group.

Results: Fifty-three men with testicular microlithiasis were identified in the 2179 ultrasound scans, giving an incidence of 2.4% for testicular microlithiasis in this asymptomatic population. Spectral Doppler examination was applied to 50 randomly chosen cases (100 testicles) without TM and 92 testicles with TM, 39 cases (78 testicles) with bilateral and 14 cases with unilateral involvement. However 48 normal testicles (17 bilateral and 14 unilateral) and 47 testicles with TM (15 bilateral and 17 unilateral, 10 of which are cases with bilateral TM) There was no significant difference regarding the RI's and spectral examinations between subjects with and without TM. An interesting finding was the twinkling artifact seen in three cases.

Conclusion: Microliths did not alter the RI values and thus had no influence on testicular perfusion in Doppler examination. The effect of TM seems to be negative as an etiologic factor in testicular tumor patients in prospective studies. Our results suggest that there is no significant association between TM and testicular cancer although it is difficult to role out such an association given the short follow-up period of our study. Additionally we described the twinkling artifact, a misleading finding creating difficulty in spectral analysis secondary to microliths, which has not been reported in TM in the literature previously.

* Will present paper

2:50 PM

269. Diffusion-weighted MR Imaging (DWI) in Differentiating Benign from Malignant Gynecologic Lesions

Holalkere N.*; Guimaraes A. S.; Hahn P. F.; Susanna L. I. Massachusetts General Hospital, Boston, MA

Address correspondence to N. Holalkere (nholalkere{at}partners.org)

Objective: To evaluate the accuracy and reproducibility of DWI in characterizing female pelvic lesions.

Materials and Methods: Twenty-four lesions on MRI with DWI performed on 19 women (mean age 55, range 24-78) over 2 months were analyzed retrospectively. Definitive diagnosis was established by histopathology (46%) or imaging stability over >6 months (median 2.7 years). MRI was performed with 1.5-T scanners with phased array coil using standard protocol along with DWI sequence. Axial and sagittal DWI was performed using a spin-echo single shot echo planar imaging FOV = 34 x 26 cm, 8/2 mm thickness/gap, 15 slices per 3.5 min free breathing sequence, TE/TR 50/5000 ms, matrix 128 x 128, b values of 0 and 1000 s/mm2. Analysis of DWI and apparent diffusion coefficient (ADC) was performed by two independent readers blinded to clinical data. On qualitative assessment, lesions were considered to have restricted diffusion if hyperintense on DWI and hypo- or isointense on ADC maps relative to myometrium. Lesions with restricted diffusion were classified malignant. Quantitative analysis involved measuring ADC values of the lesion from axial and sagittal ADC maps with reproducibility assessed by comparing the two values. Descriptive statistics and chi-square were used to differentiate benign from malignant lesion on DWI. Inter-rater variability was assessed by kappa statistical analysis.

Results: The cohort comprised 6/24 (25%) malignant (3 cervical, 1 endometrial, 2 ovarian cancers) and 18/24 (75%) benign (7 fibroid, 2 benign ovarian tumor, 4 ovarian cyst, 3 endometrioma, 2 hemorrhagic cyst) lesions. Qualitative analysis yielded a sensitivity, specificity, and accuracy of 75%, 100%, and 92%, respectively (p = 0.005) with good inter-rater agreement (k = 0.671). Quantitative analysis demonstrated mean ADC values (in mm2/sec) of 1.8 (0.2-2.7) x 10-3 for benign and 0.7 (0.4-1.1) x 10-3 for malignant lesions, respectively (p = 0.19). A cutoff ADC value of 1.0 x 10-3 below which lesions were considered malignant yielded a sensitivity, specificity, and accuracy of 83%, 55%, and 62.5%, respectively (p = 0.23). ADC values obtained from axial and sagittal images were concordant (r = 0.99, p < 0.001).

Conclusion: Qualitative DWI evaluation accurately differentiates benign from malignant gynecologic lesions. While quantitative ADC values demonstrate overlap, further evaluation may yield an upper limit threshold ADC value above which lesions are considered suspicious for malignancy. Both qualitative and quantitative DWI results are reproducible.

* Will present paper

3:00 PM

270. MR Spectroscopy of Choline as a Biomarker of Fetal Lung Maturity: Correlation with Surfactant to Albumin Ratio

Yong M. L.*; Joe B. N.; Vahidi K.; Swanson M.; Butler T.; Lu Y.; Coakley F. V.; Kurhanewicz J. University of California San Francisco, San Francisco, CA

Address correspondence to M. Yong (may.yong{at}radiology.ucsf.edu)

Objective: To determine if quantitative ex vivo MR spectroscopic evaluation of choline in amniotic fluid samples correlates with surfactant to albumin ratio, since this may ultimately allow in vivo noninvasive assessment of fetal lung maturity using MR spectroscopy in fetuses at risk for respiratory distress syndrome.

Materials and Methods: High-resolution (11.7 T) ex vivo MR spectroscopy was performed on 15 amniotic fluid samples obtained for evaluation of fetal lung maturity between 34 and 40 weeks gestation. Samples were analyzed quantitatively using trimethylsilylpropionic acid (TSP) as a reference compound. Two readers independently processed the 15 spectra and tabulated 8 metabolite peak areas (TSP, lactate doublet, alanine, citrate, creatinine, choline, lactate quartet, glucose). Choline to TSP ratio was determined for each sample and correlated with surfactant to albumin ratio (current standard for fetal lung maturity evaluation).

Results: The metabolites citrate, creatinine, choline, and lactate were readily observed in all 15 samples. The mean choline to TSP ratio (proportional to choline concentration) was 0.09 (range, 0.03 to 0.14). The mean surfactant to albumin ratio was 59 mg/g (range, 34 to 93; values greater than 49 indicating lung maturity). There was a positive trend of increasing choline to TSP ratio with increasing surfactant to albumin ratio (correlation coefficient of 0.4382, p = 0.1023).

Conclusion: Ex vivo MR spectroscopy of choline levels shows promise as a marker of fetal lung maturity given our early results showing a positive trend with surfactant to albumin ratio. Further research will be required before in vivo MR spectroscopy can be adopted for this indication.

* Will present paper

3:10 PM

271. Correlation of Endometrial FDG Uptake in Patients with Breast Cancer Treated with Tamoxifen

Patnana M.*; Iyer R.; Macapinlac H. University of Texas MD Anderson Cancer Center, Houston, TX

Address correspondence to M. Patnana (mpatnana2004{at}yahoo.com)

Objective: To determine if endometrial FDG uptake corresponds to tamoxifen related changes on FDG-PET/CT in breast cancer patients

Materials and Methods: Retrospective analysis was performed on breast cancer patients treated with tamoxifen. The medical records and PET/CT studies of 250 breast cancer patients were reviewed. Forty-six of these patients (age 27-90 years) had previously been treated or were currently on tamoxifen therapy and were not post hysterectomy. Twenty-nine patients were postmenopausal, fifteen were premenopausal and 2 were perimenopausal. Patients varied in duration and completion of tamoxifen therapy prior to PET/CT examination. 2D PET study was performed one hour post administration of 15-20 mCi of 18F-FDG. Non-contrast CT was performed for attenuation correction and diagnosis. Patients were scanned using a Discovery ST 16 (GE Healthcare-Milwaukee, WI) system and images were reviewed on a GE Advantage Windows workstation. Review of the PET/CT examinations and patients' histories was performed by two radiologists and one nuclear medicine physician with experience in PET/CT. Maximum and mean standard uptake values (SUV) were obtained using a 3D region of interest in patients demonstrating increased endometrial FDG uptake relative to myometrial uptake.

Results: Six patients had increased endometrial activity (SUV max: 3.1-4.6 and mean: 2.0-3.1) and five of these were related to menses. The sixth patient was postmenopausal with increasing endometrial thickening on CT and ultrasound, but no malignancy on endometrial biopsy. Twenty-six of the remaining 40 patients showed no endometrial uptake and no abnormal endometrial changes on follow-up.

Conclusion: PET/CT in breast cancer patients treated with tamoxifen may incidentally identify nonspecific endometrial uptake that should be correlated with other imaging or biopsy to exclude tamoxifen related changes such as endometrial polyps, hyperplasia and cancer in postmenopausal patients. In premenopausal patients endometrial uptake may be physiologic and should be correlated with the menstrual cycle. If no abnormal FDG uptake is identified, the probability of tamoxifen related changes is less likely.

* Will present paper

* Will present paper

3:20 PM

272. Improved Effectiveness of MR-guided Focused Ultrasound Surgery for Uterine Fibroids Utilizing Commercial Treatment Guidelines

LeBlang S.1*; Steinberg F.1 1. University MRI, Boca Raton, FL;

Address correspondence to S. LeBlang (sleblang{at}universitymri.com)

Objective: To demonstrate that the expanded commercial treatment guidelines allow for increased coagulation necrosis in the fibroids compared with the FDA pivotal study and results in improved patient symptomotolgy.

Materials and Methods: 73 patients with 108 fibroids were treated with transcorporeal MR-guided focused ultrasound. The average number of sonications per patient was 50 with mean energies of 2100 joules per sonication. The aver-age fibroid volume was 138 cc. In the FDA study, treatments were limited to 2 hours and the volume of tissue treated was less than 150 cc. With the expanded commercial treatment guidelines, the treatment time was increased to 3 hours and there was no restriction on the volume of tissue treated. Immediately post procedure, the amount of coagulation necrosis (ablated nonperfused tissue) was measured on post contrast fat saturation images. Patients were followed at 1 day, 1 week, and 6 months at which time a follow-up MRI was performed to evaluate the involution of coagulation (shrinkage) and any residual areas of necrosis.

Results: The average amount of coagulation necrosis per fibroid was 57.8%, compared to 10% in the FDA pivotal study. Of the 55 fibroids that were thus far followed up and re-evaluated at 6 months, the average shrinkage was 34% compared to 15.6% in the FDA pivotal study. Of the 73 patients, 6/73(8%) went on to hysterectomy versus 22% in the FDA study. Of these 3/6 had T2 hyperintense fibroids that are less responsive to ultrasound heating and only resulted in <20% coagulation necrosis, 1/6 needed surgery for bladder incontinence and while in surgery had a hysterectomy, 1/6 had a fibroid load of over 1000 cc's and only 5 fibroids out of 20 were treated and she was, in retrospect, not a good candidate for this procedure to the excessive fibroid load and 1/6 had a hysterectomy due to persistent symptoms despite a satisfactory treatment with a fibroid volume of 196 cc and a 45 % shrinkage at 6 months.

Conclusion: The expanded commercial treatment guidelines for MR-guided focused ultrasound results in a larger zone of coagulation necrosis and an improved primary effectiveness rate. The subset of patients with 6-month follow-up received improved treatment effectiveness that resulted in more shrinkage compared to the FDA pivotal study. With the improved technical success utilizing the commercial treatment guidelines, patients experienced faster and improved symptomatic relief with a decreased need for hysterectomy.


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