Gina K. Hesley

Frequency and severity of adverse effects of iodinated and gadolinium contrast materials: retrospective review of 456,930 doses.

OBJECTIVE The purpose of this study was to determine the frequency and characteristics of adverse effects of low-osmolar iodinated and gadolinium contrast agents in a single-center experience with a large number of cases. MATERIALS AND METHODS A retrospective review of all intravascular doses of low-osmolar iodinated and gadolinium contrast materials administered from 2002 through 2006 was conducted. Adverse effects were identified through the use of radiologist and nurse event recording. Adverse effects were examined for type and severity of reaction, treatment required, and outcome. RESULTS A total of 456,930 contrast doses (298,491 low-osmolar iodinated, 158,439 gadolinium) were administered over the study period. A total of 522 cases of adverse effects (0.11% of total) were identified (458 low-osmolar iodinated, 64 gadolinium). The most common adverse effects were hives (274, 52.5%) and nausea (92, 17.6%). Of all adverse effects, 79 of low-osmolar iodinated and 15 of gadolinium contrast material necessitated treatment. Most treatments were performed in the radiology department alone. Only 16 cases of adverse effects necessitated transfer for further observation or treatment. Epinephrine was used to manage an adverse effect in nine instances. Thirty-two of the adverse effects of low-osmolar iodinated contrast material (6.9%) occurred in patients with a history of allergy who received premedication. Only two of these premedication reactions necessitated transfer to the emergency department. The one death in the study period occurred after administration of low-osmolar iodinated contrast material. The patient had no symptoms during the contrast administration or imaging but died suddenly within 30 minutes of receiving the dose. CONCLUSION Both iodinated and gadolinium contrast agents are associated with a very low rate of adverse effects. Most adverse effects are mild and can be managed in the radiology department. Transfer for additional treatment or observation is rarely needed.

Incidence of Bleeding After 15,181 Percutaneous Biopsies and the Role of Aspirin

OBJECTIVE The objective of our study was to report the incidence of bleeding after imaging-guided percutaneous core biopsy at a single center using a standardized technique. MATERIALS AND METHODS We performed a retrospective review of percutaneous core biopsies performed at our institution from January 2002 through February 2008. Data were collected at the time of biopsy, and clinical information was obtained 24 hours and 3 months after the biopsy. The specific information that was collected included the results of coagulation studies, aspirin use, the organ biopsied, the size of the biopsy needle, and the number of needle passes. Bleeding complications were defined using the Common Terminology Criteria for Adverse Events (CTCAE, version 3.0) established by the National Cancer Institute. RESULTS Among the 15,181 percutaneous core biopsies performed during the study period, 70 hemorrhages (0.5%) that were CTCAE grade 3 or greater were identified within 3 months of biopsy. The incidence of bleeding in patients taking aspirin within 10 days before biopsy was 0.6% (18/3,195), which was not statistically different compared with the incidence of bleeding in those not taking aspirin (52/11,986, 0.4%; p = 0.34). The incidence of bleeding after liver biopsy was 0.5%; kidney biopsy, 0.7%; lung biopsy, 0.2%; pancreas biopsy, 1.0%; and other biopsy, 0.2%. There were significant associations between major bleeding and serum platelet count and international normalized ratio (p < 0.001), although the association between major bleeding and the size of the biopsy needle was not significant (p = 0.97). CONCLUSION The overall incidence of major bleeding after imaging-guided percutaneous core needle biopsy is low. Recent aspirin therapy does not appear to significantly increase the risk of such bleeding complications.

Magnetic resonance-guided focused ultrasound of uterine leiomyomas: review of a 12-month outcome of 130 clinical patients.

PURPOSE To assess 12-month outcomes and safety of clinical magnetic resonance (MR)-guided focused ultrasound (US) treatments of uterine leiomyomas. MATERIALS AND METHODS Between March 2005 and December 2009, 150 women with symptomatic uterine leiomyomas were clinically treated with MR-guided focused US at a single institution; 130 patients completed treatment and agreed to have their data used for research purposes. Patients were followed through retrospective review of medical records and phone interviews conducted at 3-, 6-, and 12-month intervals after treatment to assess additional procedures and symptom relief. Outcome measures and treatment complications were analyzed for possible correlations with the appearance of the tumors on T2-weighted imaging. RESULTS The cumulative incidence of additional tumor-related treatments 12 months after MR-guided focused US was 7.4% by the Kaplan-Meier method. At 3-, 6-, and 12-month follow-up, 86% (90 of 105), 93% (92 of 99), and 88% (78 of 89) of patients reported relief of symptoms, respectively. No statistically significant correlation between tumor appearance on T2-weighted imaging and 12-month outcome was found. Treatment-related complications were observed in 17 patients (13.1%): 16 patients had minor complications and one had a major complication (deep vein thrombosis). All complications were resolved within the 12-month follow-up period. CONCLUSIONS MR-guided focused US is a noninvasive treatment option that can be used to effectively and safely treat uterine leiomyomas and delivers significant and lasting symptom relief for at least 12 months. The incidence of additional treatment during this time period is comparable with those in previous reports of uterine artery embolization.

A Clinical Review of Focused Ultrasound Ablation With Magnetic Resonance Guidance: An Option for Treating Uterine Fibroids

Uterine fibroids are common smooth muscle tumors, which can result in substantial symptoms affecting the quality of life of women. Whereas patients have several options available for treatment, focused ultrasound ablation is one of the least invasive treatment options outside medical therapy. Magnetic resonance-guided focused ultrasound (MRgFUS) ablation combines therapy delivered by an ultrasound transducer with imaging, guidance for therapy, and thermal feedback provided by magnetic resonance imaging. In 2004, the MRgFUS system ExAblate 2000 (InSightec, Haifa, Israel) was approved by the United States Food and Drug Administration for clinical treatments of uterine fibroids. Since its approval, our institution has performed more than 140 treatments. This paper provides an overview of our sites clinical experience with MRgFUS, including a brief description of the treatment system, pertinent features to review on screening magnetic resonance imaging, how the procedure is performed, and risks and benefits of the treatment. Some potential clinical applications of the technology are also briefly reviewed.

MR-guided focused ultrasound for the treatment of uterine fibroids.

Magnetic resonance imaging–guided focused ultrasound (MRgFUS) ablation of uterine fibroids provides a minimally invasive outpatient technique for targeting and treating symptomatic uterine fibroids. Magnetic resonance imaging provides a guidance platform that has high temporal and spatial resolution for guiding, as well as thermal monitoring of the procedure. The high-intensity focused ultrasound provides a mechanism for delivering large amounts of energy directly into the fibroid without causing detrimental effects to the nontarget tissues. Early and intermediate follow-up of patients treated with MRgFUS provided promising results on the efficacy of the technique for providing symptom relief to patients. As more long-term follow-up data are published, the efficacy of this technique can be compared to more invasive surgical and minimally invasive catheter treatments.

Comparing focused ultrasound and uterine artery embolization for uterine fibroids-rationale and design of the Fibroid Interventions: reducing symptoms today and tomorrow (FIRSTT) trial.

OBJECTIVE To present the rationale, design, and methodology of the Fibroid Interventions: Reducing Symptoms Today and Tomorrow (FIRSTT) study. DESIGN Randomized clinical trial. SETTING Two academic medical centers. PATIENT(S) Premenopausal women with symptomatic uterine fibroids. INTERVENTION(S) Participants are randomized to two U.S. Food and Drug Administration-approved minimally invasive treatments for uterine leiomyomas: uterine artery embolization and magnetic resonance-guided focused ultrasound. MAIN OUTCOME MEASURE(S) The primary endpoint is defined as the need for an additional intervention for fibroid symptoms following treatment. Secondary outcomes consist of group differences in symptom alleviation, recovery trajectory, health-related quality of life, impairment of ovarian reserve, treatment complications, and the economic impact of these issues. RESULT(S) The trial is currently in the phase of active recruitment. CONCLUSION(S) This randomized clinical trial will provide important evidence-based information for patients and health care providers regarding optimal minimally invasive treatment approach for women with symptomatic uterine leiomyomas. CLINICAL TRIAL REGISTRATION NCT00995878.

Magnetic resonance-guided focused ultrasound surgery for leiomyoma-associated infertility.

Objective To describe magnetic resonance-guided focused ultrasound surgery (FUS) as a treatment for a case of leiomyoma-associated infertility. Design Case report from a randomized clinical trial. Setting Academic medical center. Patient(s) A 37-year-old woman with known leiomyomas and a history of 18 months of home-inseminations from a known donor. Intervention(s) Magnetic resonance-guided FUS treatment of uterine fibroids, where the dominant fibroid distorted the uterine cavity. Main Outcome Measure(s) Pregnancy. Result(s) A viable intrauterine pregnancy, with a full-term vaginal delivery, was conceived after a single clomiphene citrate and intrauterine insemination cycle. Conclusion(s) The role of FUS for enhancement of fertility in women with nonhysteroscopically resectable uterine fibroids distorting the uterine cavity should be investigated further.

Incidence of Infectious Complications After an Ultrasound-Guided Intervention

OBJECTIVE The objective of our study was to determine the incidence of infectious complications of common ultrasound-guided procedures including fine-needle aspiration (FNA), drain placement, biopsy, pseudoaneurysm thrombin injection, thoracentesis, and paracentesis. SUBJECTS AND METHODS The infection prevention and control (IPAC) committee at the Mayo Clinic, Rochester, MN, conducts surveillance of selected infections including radiology procedures. When a positive culture, hospital admission, or operating room visit for infection is identified, the patients electronic records are thoroughly reviewed by an infection control practitioner looking for information about prior interventions. Similarly, the department of radiology prospectively follows all patients who have undergone ultrasound-guided hepatic, renal, and pancreatic biopsies for complications 24 hours, 3 months, and 12 months after biopsy. We reviewed 2 years of these data to determine the incidence of infections after common ultrasound-guided procedures. RESULTS We performed 13,534 ultrasound-guided procedures from January 2006 to December 2007. There were 11 likely and three possible procedure-related infections for an overall incidence of 0.1% (14/13,534). The infections consisted of five abscesses, four bloodstream infections, four cases of peritonitis, and one urinary tract infection. The highest incidence of infections occurred after ultrasound-guided biopsy (0.2%, 10/5,487), with biopsy of a hepatic transplant having the highest incidence (1.0%, 2/192). No infections occurred after thoracentesis and FNA despite the large number of procedures performed (2,489 and 2,340, respectively). Nearly all patients improved on antibiotics. One patient died 5 days after paracentesis; however, death was likely due to multiorgan failure in the setting of fulminant liver failure with hepatorenal syndrome. CONCLUSION The incidence of a serious infectious complication after ultrasoundguided intervention is low. Radiologists can use these data to provide more accurate information to patients when asking for consent before procedures and to reassure their patients.

Incidence of additional treatments in women treated with MR-guided focused US for symptomatic uterine fibroids: Review of 138 patients with an average follow-up of 2.8 years

PURPOSE To assess long-term outcomes of magnetic resonance (MR)-guided focused ultrasound (US) treatments of uterine fibroids. MATERIALS AND METHODS A retrospective follow-up of 138 patients treated at a single institution between March 2005 and November 2011 was conducted. The patients were not part of a clinical study and were followed through retrospective review of their medical records and telephone interviews to assess additional treatments for fibroid-related symptoms. Survival methods, including Cox proportional hazards models, were used to assess the association between incidence of additional treatments and patient data obtained during screening before treatment. RESULTS The average length of follow-up was 2.8 years (range, 1-7.2 y). The cumulative incidence of additional treatments at 36 months and 48 months after MR-guided focused US was 19% and 23%, respectively. Women who did not need additional treatment were older than women who did (46.3 y ± 5.6 vs 43.0 y ± 5.8; P = .006; hazard ratio, 0.855; 95% confidence interval, 0.789-0.925). Additionally, women with heterogeneous or bright fibroids on T2-weighted MR imaging were more likely to require additional treatment compared with women with homogeneously dark fibroids (hazard ratio, 5.185 or 5.937, respectively; 95% confidence interval, 1.845-14.569 or 1.401-25.166, respectively). Physician predictions of treatment success, recorded during the screening process, had significant predictive value (P = .018). CONCLUSIONS The long-term rates of additional interventions after MR-guided focused US of symptomatic uterine fibroids were found to be comparable with other uterine-sparing procedures, such as uterine artery embolization or myomectomy. Older patient age and homogeneously dark fibroids were associated with fewer additional treatments. Physician assessment of treatment success was found to be a valuable tool in patient screening.

The Timing and Presentation of Major Hemorrhage After 18,947 Image-Guided Percutaneous Biopsies

OBJECTIVE The objective of our study was to characterize the temporal and clinical manifestation of major bleeding events after biopsy to guide clinicians in the institution of appropriate surveillance. MATERIALS AND METHODS We performed a retrospective review of percutaneous image-guided biopsies performed between September 1, 2005, and May 31, 2012, including 18,947 biopsy events. According to routine protocol, follow-up telephone calls were made to patients 24 hours after biopsy, and chart review was performed 3 months after biopsy. Bleeding complications were defined using the Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) established by the National Cancer Institute. In patients with a grade 3 or greater bleeding complication, a retrospective chart review was performed to characterize the details of the complication including the timing of the complication and the primary clinical presentation of the event. RESULTS Grade 3 hemorrhage was associated with 64 of 18,947 (0.3%) procedures, and there were three deaths associated with the biopsy event (0.02% or ≈ 2/10,000). Hemorrhage was most commonly associated with biopsy of a native kidney (17/1407, 1.2%). Twenty patients (31%) presented with a bleeding complication within 1 hour of biopsy. Twenty-seven patients (42%) presented within 2 hours of biopsy. Fifty-two patients (81%) presented within 24 hours, and the remaining 12 patients (19%) presented more than 24 hours after biopsy. Pain was the most common presentation of patients with bleeding complications, occurring in 39 (61%) patients. CONCLUSION The incidence of major bleeding after percutaneous biopsies is very low, but delayed complications occur more frequently than anticipated. Pain is the most common clinical presentation of major bleeding complications.