John C Lipman’s research while affiliated with Georgetown University and other places

To determine the long-term outcome of uterine fibroid therapy (UFE) using tris-acryl gelatin microspheres (TAGM). This was a multicenter prospective study of patients undergoing UFE with TAGM, and during this phase of the study, the clinical outcomes 3 years after treatment were assessed. Measures of outcome included the Ruta Menorrhagia Questionnaire, patient self-assessments of symptoms and impact on activities, patient satisfaction and health-related quality of life as measured by the SF-12. Long-term re-intervention rates were also assessed. The data were analyzed at each interval compared to baseline using appropriate statistical tests. Of the 102 patients enrolled, 96 patients had complete baseline data and of these, 69 (72%) had known outcomes at 3 years after treatment. Sixty-one patients (64%) completed long-term follow-up without major intervention. An additional 8 patients (8.3%) underwent fibroid surgery (7 hysterectomies and 1 myomectomy). Among those without intervention, at 3 years after treatment, the mean Ruta Questionnaire Score was 19.3, compared to 47.9 at baseline and 24.5 at 3 months (P <.01). At baseline, 57% of patients had extremely heavy bleeding, while only 2% had that complaint at 36 months. At 36 months, much or moderate improvement in pelvic pain occurred in 83% of patients, pelvic discomfort in 83%, and urinary problems in 69% and 84% were moderately or very satisfied with their outcome. Over the long-term, UFE using TAGM is effective and safe, with high levels of durable symptom control, improved health-related quality of life and patient satisfaction.

To prospectively evaluate the safety and effectiveness of polyvinyl alcohol (PVA) microspheres in patients undergoing uterine artery embolization (UAE) to treat uterine fibroid tumors and to compare the long-term changes in health-related quality of life (QOL) after UAE with the changes seen after myomectomy. One hundred forty-six patients with uterine myomas were enrolled into this multicenter study, with 77 patients undergoing UAE with PVA and 69 patients undergoing myomectomy. Six-month follow-up was completed for the myomectomy, whereas 2-year follow-up was completed for the UAE group. Outcomes were assessed with the Uterine Fibroid QOL Questionnaire and based on adverse event incidence, time to return to normal activity, and changes in tumor symptom scores, QOL scores, and menorrhagia bleeding scores. For the UAE cohort, changes in total uterine volume and dominant tumor size on magnetic resonance (MR) imaging were assessed. In the UAE cohort, 88.3% of patients experienced a reduction of tumor-related symptoms (increase >or=5 points from baseline measurement) at 6 months, with 75.4% of patients in the myomectomy group experiencing similar improvement. Median QOL questionnaire scores at 6 months were found to be significantly higher in patients treated with UAE (P = .041), with sustained improvement seen at 12 and 24 months. Both procedures resulted in significant reductions in 6-month menorrhagia bleeding scores, with sustained improvement in the UAE cohort at 12 and 24 months. MR imaging at 6 months revealed significant uterine and tumor volume reductions after UAE (P < .05). At least one adverse event occurred in 42% of patients in the myomectomy group, compared with 26% in the UAE group (P < .05). UAE performed with PVA microspheres was associated with greater sustained improvements in symptom severity and health-related QOL and with fewer complications compared with myomectomy. Six-month MR imaging data demonstrated significant reductions in uterine and tumor volumes, although the degree of tissue infarction after UAE was not assessed with contrast medium-enhanced MR imaging.

To determine whether there is significant quality of life score improvement after uterine artery embolization (UAE) and to compare UAE and myomectomy outcomes. Prospective cohort controlled study. Sixteen medical centers in the United States. One hundred forty-nine UAE patients and 60 myomectomy patients. Patients were assigned to myomectomy or UAE on the basis of a best treatment decision made by the patient and her physician. All patients were observed for 6 months. The UAE patients also had follow-up examinations at 1 year. Myomectomy or UAE. Quality of life score changes, menstrual bleeding score changes, uterine size differences, time off, and adverse events. Both groups experienced statistically significant improvements in the uterine fibroid quality of life score, menstrual bleeding, uterine volume, and overall postoperative quality of life. The mean hospital stay was 1 day for the UAE patients, compared with 2.5 days for the myomectomy patients. The UAE and myomectomy patients returned to their normal activities in 15 days and 44 days, respectively, and returned to work in 10 days and 37 days, respectively. At least one adverse event occurred in 40.1% of the myomectomy patients, compared with 22.1% in the UAE group. The uterine fibroid quality of life score was significantly improved in both groups. No significant differences were observed in bleeding improvement, uterine volume reduction, uterine fibroid quality of life score improvement, and overall quality of life score improvement between groups. Patients receiving UAE required fewer days off work, fewer hospital days, and experienced fewer adverse events.

The purpose of this study was to estimate the outcomes of uterine embolization and hysterectomy for uterine leiomyomas. Study design This was a multicenter prospective study of patients who were treated with embolization (n=102 patients) and hysterectomy (n=50 patients) for leiomyomas. Changes in symptoms, complications, and quality of life were measured. The data analysis included linear and logistic regression, the Student t and paired t test, Fisher's exact test, and chi-squared test. For patients who underwent embolization, there were marked reductions in blood loss scores (P <.001) and menorrhagia questionnaire scores (P <.001) compared with baseline. At 12 months, a larger proportion of the patients who had undergone hysterectomy experienced improved pelvic pain (P=.021). Both groups had marked improvement in other symptoms and quality of life scores, with no difference between groups. Complications were more frequent in patients who underwent hysterectomy (50% vs 27.5%; P=.01). Both procedures substantially improved symptoms for most patients, with an advantage for hysterectomy at 12 months for pelvic pain. Serious complications were infrequent in both groups.

Successful superselective catheterization of the uterine artery requires familiarity with female pelvic arterial anatomy, knowledge of effective catheter and guidewire combinations, and a few tricks. A learning curve can be expected for each of these elements, although it is assumed that the operator will already have experience in basic catheter techniques. Safe transcatheter delivery, understanding of embolization end points, and avoidance of nontarget embolization are essential. Equally important are knowledge of the properties of the embolic agents currently available and their indications for use. Uterine fibroid embolization unavoidably results in radiation exposure to the uterus and ovaries, and adherence to meticulous fluoroscopic technique is crucial to keep the absorbed dose as low as possible.

Patients generally notice some relief of both menorrhagia and mass-effect symptoms during the first few weeks after uterine fibroid embolization (UFE). Shrinkage of the fibroids continues to take place over several months, peaking somewhere between 3 and 6 months, with measurable shrinkage sometimes noted for up to 1 year. The timing of follow-up visits is intended to coincide with the time course of improvement so that diagnostic imaging and intervention can be performed if symptoms worsen or relief does not appear to be on schedule. The amount of shrinkage of fibroids correlates neither with the intensity of immediate postprocedure symptoms or the degree of symptom relief. Affected fibroids undergo hyaline degeneration, a process in which the hard, cellular tumor is replaced by softer, acellular material. A nationwide registry has been constructed for the accumulation of procedural and follow-up data so that success and complication rates can be accurately determined and long-term issues about the durability of UFE and possible side effects can be addressed.

Building a uterine fibroid embolization (UFE) practice can be a complex process. Choices must be made regarding whether to align oneself with a gynecologist or to accept direct referrals. For the interventional radiologist, the responsibilities of evaluation and patient care pose unique and time-consuming administrative and clinical challenges. Physician extenders, either nurse practitioners or physician's assistants, play key roles as clinical coordinators by guiding the patient through the medical system and making certain that she is cleared for the procedure medically and logistically. In some settings, they may also assist in many of the technical aspects of the procedure and postoperative care. Interventional radiologists must be prepared for battles with insurance companies and be willing to go through the appeals process. Business officers must also be trained to properly code for the procedures to insure optimal reimbursement. The success of building a UFE practice may also be bolstered by directly marketing to patients and by providing them with access via the Internet.