Gaylene Pron

The Ontario Uterine Fibroid Embolization Trial. Part 2. Uterine fibroid reduction and symptom relief after uterine artery embolization for fibroids

OBJECTIVE To evaluate fibroid uterine volume reduction, symptom relief, and patient satisfaction with uterine artery embolization (UAE) for symptomatic fibroids. DESIGN Multicenter, prospective, single-arm clinical treatment trial. SETTING Eight Ontario university and community hospitals. Five hundred thirty-eight patients undergoing bilateral UAE. INTERVENTION(S) Bilateral UAE performed with polyvinyl alcohol particles sized 355-500 microm. MAIN OUTCOME MEASURE(S) Three-month follow-up evaluations including fibroid uterine volume reductions, patient reported symptom improvement (7-point scale), symptom life-impact (10-point scale) reduction, and treatment satisfaction (6-point scale). RESULT(S) Median uterine and dominant fibroid volume reductions were 35% and 42%, respectively. Significant improvements were reported for menorrhagia (83%), dysmenorrhea (77%), and urinary frequency/urgency (86%). Mean menstrual duration was significantly reduced after UAE (7.6 to 5.4 days). Improvements in menorrhagia were unrelated to pre-UAE uterine size or post-UAE uterine volume reduction. Amenorrhea occurring after the procedure was highly age dependent, ranging from 3% (1%-7%) in women under age 40 to 41% (26%-58%) in women age 50 or older. Median fibroid life-impact scores were significantly reduced after UAE (8.0 to 3.0). The majority (91%) expressed satisfaction with UAE treatment. CONCLUSION(S) UAE reduced fibroid uterine volume and provided significant relief of menorrhagia that was unrelated to initial fibroid uterine size or volume reduction. Patient satisfaction with short-term UAE treatment outcomes was high.

Pregnancy after uterine artery embolization for leiomyomata: the Ontario multicenter trial.

OBJECTIVE: To report on pregnancies and deliveries occurring in a large cohort of women who underwent uterine artery embolization instead of surgery for symptomatic leiomyomata. METHODS: A total of 555 women underwent uterine embolization in a multicenter clinical trial. The primary embolic agent was 355–500 μm polyvinyl alcohol particles with treatment end-point as bilateral stasis in the uterine arteries. Women desiring pregnancy were informed of the uncertain effect of embolization on fertility and pregnancy. Average age at embolization was 43 years (range 18–59 years). Thirty-one percent were younger than age 40 years. Women were followed up prospectively by telephone, and obstetric records of the women who conceived were reviewed. RESULTS: Twenty-one women of average age 34 years (range 27–42 years) conceived, (3 of these twice), and 13 women were nulliparous. Twenty-three of the 24 pregnancies were conceived spontaneously (1 woman had in vitro fertilization). There were 4 spontaneous abortions (16.7%, 95% confidence interval 5.4–41.9%) and 2 elective pregnancy terminations. Fourteen of the 18 live births were full term and 4 were preterm. There were 9 vaginal deliveries and 9 cesarean deliveries, 4 of which were elective. Abnormal placentation occurred in 3 cases, all nulliparas (12.5% 95% confidence interval 3.1–36.3%). Two cases developed placenta previa (1 had a clinical partial accreta) and the third developed a placenta membranacea with accreta resulting in cesarean hysterectomy. Three postpartum hemorrhages all secondary to placental abnormalities occurred. Four newborns were small for gestational age (≤ 5th percentile); 2 of these pregnancies were complicated by gestational hypertension. CONCLUSION: Women are able to achieve pregnancies after uterine artery embolization, and most resulted in term deliveries and appropriately grown newborns. Close monitoring of placental status, however, is recommended. LEVEL OF EVIDENCE: II-3

Craniofacial Skeletal Measurements Based on Computed Tomography: Part II. Normal Values and Growth Trends

Current diagnosis and surgical correction of craniofacial anomalies would benefit from accurate quantitative and standardized points of reference. A retrospective study was undertaken to define normal values for a series of craniofacial measurements and to evaluate the growth patterns of the craniofacial complex through axial computed tomography (CT). Fifteen measurements were taken from 542 CT scan series of skeletally normal subjects. The measurement values were then divided into 1-year age categories from 1 to 17 years, and into four age groups for those under 1 year of age. The normal range and growth pattern of measurement values for the cranial vault, orbital region, and upper midface are presented. The overall size of the cranio-orbito-zygomatic skeleton reaches more than 85 percent of adult size by age 5 years. The cranial vault grows rapidly in the first year of life but growth levels off early. The upper midface grows at a slower rate in infancy, but continues to grow later in childhood and early adolescence. Knowledge of the differential growth patterns and normal measurement values in the craniofacial region will help improve diagnostic accuracy, staging of reconstruction, precision of corrective surgery, and follow-up of patients.

Uterine Artery Embolization for Treatment of Leiomyomata: Long-term Outcomes From the Fibroid Registry

OBJECTIVE: To assess long-term clinical outcomes of uterine artery embolization across a wide variety of practice settings in a large patient cohort. METHODS: The Fibroid Registry for Outcomes Data (FIBROID) for Uterine Embolization was a 3-year, single-arm, prospective, multi-center longitudinal study of the short- and long-term outcomes of uterine artery embolization for leiomyomata. Two thousand one hundred twelve patients with symptomatic leiomyomata were eligible for long-term follow-up at 27 sites representing a geographically diverse set of practices, including academic centers, community hospitals, and closed-panel health maintenance organizations. At 36 months after treatment, 1,916 patients remained in the study, and of these, 1,278 patients completed the survey. The primary measures of outcome were the symptom and health-related quality-of-life scores from the Uterine Fibroid Symptom and Quality of Life questionnaire. RESULTS: Mean symptom scores improved 41.41 points (P<.001), and the quality of life scores improved 41.47 points (P<.001), both moving into the normal range for this questionnaire. The improvements were independent of practice setting. During the 3 years of the study, Kaplan-Meier estimates of hysterectomy, myomectomy, or repeat uterine artery embolization were 9.79%, 2.82%, and 1.83% of the patients, respectively. CONCLUSION: Uterine artery embolization results in a durable improvement in quality of life. These results are achievable when the procedure is performed in any experienced community or academic interventional radiology practice. LEVEL OF EVIDENCE: III

Screening for oropharyngeal dysphagia in stroke: insufficient evidence for guidelines.

There is no evaluation of the evidence for the screening of oropharyngeal dysphagia in stroke. We reviewed the literature on clinical screening for oropharyngeal dysphagia in adults with stroke to determine (a) the accuracy of different screening tests used to detect dysphagia defined by abnormal oropharyngeal physiology on videofluoroscopy and (b) the health outcomes reported and whether screening alters those outcomes. Peer-reviewed English-language and human studies were sought through Medline (from 1966 to July 1997) by using the key words cerebrovascular disorders and deglutition disorders, relevant Internet addresses, and extensive hand searching of bibliographies of identified articles. Of the 154 sources identified, 89 articles were original, peer-reviewed, and focused on oropharyngeal dysphagia in stroke patients. To evaluate the evidence, the next selection identified 10 articles on the comparison of screening and videofluoroscopic findings and three articles on screening and health outcomes. Evidence was rated according to the level of study design by using the values of the Canadian Task Force on Periodic Health Examination. From the identified screening tests, most of the screenings were related to laryngeal signs (63%) and most of the outcomes were related to physiology (74%). Evidence for screening accuracy was limited because of poor study design and the predominant use of aspiration as the diagnostic reference. Only two screening tests were identified as accurate: failure on the 50-ml water test (likelihood ratio = 5.7, 95% confidence interval = 2.5–12.9) and impaired pharyngeal sensation (likelihood ratio = 2.5, 95% confidence interval = 1.7–3.7). Limited evidence for screening benefit suggested a reduction in pneumonia, length of hospital stay, personnel costs, and patient charges. In conclusion, screening accuracy needs to be assessed by using both abnormal physiology and aspiration as diagnostic markers for dysphagia. Large well-designed trials are needed for more conclusive evidence of screening benefit.

Pediatric facial farctures: Evolving patterns of treatment

This study reviews the treatment of facial trauma between October 1986 and December 1990 at a major pediatric referral center. The mechanism of injury, location and pattern of facial fractures, pattern of facial injury, soft tissue injuries, and any associated injuries to other organ systems were recorded, and fracture management and perioperative complications reviewed. The study population consisted of 137 patients who sustained 318 facial fractures. Eighty-one patients (171 fractures) were seen in the acute stage, and 56 patients (147 fractures) were seen for reconstruction of a secondary deformity. Injuries in boys were more prevalent than in girls (63% versus 37%), and the 6- to 12-year cohort made up the largest group (42%). Most fractures resulted from traffic-related accidents (50%), falls (23%), or sports-related injuries (15%). Mandibular (34%) and orbital fractures (23%) predominated; fewer midfacial fractures (7%) were sustained than would be expected in a similar adult population. Three quarters of the patients with acute fractures required operative intervention. Closed reduction techniques with maxillomandibular fixation were frequently chosen for mandibular condyle fractures and open reduction techniques (35%) for other regions of the facial skeleton. When open reduction was indicated, plate-and-screw fixation was the preferred method of stabilization (65%). The long-term effects of the injuries and the treatment given on facial growth remain undetermined. Perioperative complication rates directly related to the surgery were low.

Pediatric facial fractures: evolving patterns of treatment

This study reviews the treatment of facial trauma between October 1986 and December 1990 at a major pediatric referral center. The mechanism of injury, location and pattern of facial fractures, pattern of facial injury, soft tissue injuries, and any associated injuries to other organ systems were recorded, and fracture management and perioperative complications reviewed. The study population consisted of 137 patients who sustained 318 facial fractures. Eighty-one patients (171 fractures) were seen in the acute stage, and 56 patients (147 fractures) were seen for reconstruction of a secondary deformity. Injuries in boys were more prevalent than in girls (63% versus 37%), and the 6- to 12-year cohort made up the largest group (42%). Most fractures resulted from traffic-related accidents (50%), falls (23%), or sports-related injuries (15%). Mandibular (34%) and orbital fractures (23%) predominated; fewer midfacial fractures (7%) were sustained than would be expected in a similar adult population. Three quarters of the patients with acute fractures required operative intervention. Closed reduction techniques with maxillomandibular fixation were frequently chosen for mandibular condyle fractures and open reduction techniques (35%) for other regions of the facial skeleton. When open reduction was indicated, plate-and-screw fixation was the preferred method of stabilization (65%). The long-term effects of the injuries and the treatment given on facial growth remain undetermined. Perioperative complication rates directly related to the surgery were low. Language: en

The Fibroid Registry for outcomes data (FIBROID) for uterine embolization: short-term outcomes.

Objective: To investigate the short-term safety of uterine embolization for leiomyomata in a large cohort of patients treated in a variety of clinical settings. Methods: Examining the FIBROID Registry, a multicenter prospective voluntary registry of patients undergoing uterine embolization for leiomyomata, we studied the frequency of adverse events and predictors of adverse events within 30 days of the procedure. We also report on the technical aspects of the procedure, including details of periprocedural care, technique, and short-term recovery. All adverse events were recorded and classified using standard definitions, both in terms of type and severity. Summary statistics were used to describe the data set, and univariate and multivariate analyses were used to determine which factors might influence the incidence of adverse events. Results: Of the 3,160 patients enrolled at 72 contributing sites, major in-hospital complications occurred in 0.66%, and postdischarge major events occurred in 4.8% within the first 30 days. The most common adverse event after discharge was inadequate pain relief requiring additional hospital treatment (2.4%). Thirty-one patients required additional surgical intervention within 30 days after treatment, 3 of whom required hysterectomy (0.1%). There were no deaths. Multivariate analysis showed modest increased odds for an adverse event for African Americans, smokers, and those with prior leiomyoma procedures. There were no differences in outcome based on the practice site experience, practice type, or any procedure-related factors. Conclusion: Uterine embolization for leiomyomata is a low-risk procedure with little variability in short-term outcome based on either patient demographics or practice setting. Level of Evidence: II-3

Growth patterns of the nasolabial region: a morphometric study.

Age-related growth changes in the nasolabial region were analyzed through six measurements taken between 1 year and 18 years of age in 1,593 North American Caucasians. By 1 year of age, the length of the cutaneous portion of the upper lip and the width of the nose showed the highest levels of development compared with their adult size, 80.3 and 79.5%, respectively. By 5 years, the developmental level of the nasolabial region except nasal tip protrusion approached their maturation level. Our nasal measurements indicated that growth of the nose between 5 and 18 years was significantly greater than that of the upper lip, which revealed significantly greater growth increments between 1 and 5 years of age. The cutaneous upper lip height reached its adult size in 3-year-old females (12.7 mm) and 6-year-old males (14.4 mm). Nose width and height were fully developed in females by age 12 and in males by age 14 or 15. Rapid growth occurred in the upper lip, nose height, and nasal tip protrusion between the ages of 1 and 4 years. Knowledge of these age-related morphologic variations within the nose and upper lip may be useful in planning the time and type of reconstructive surgery and in anticipating further change in the operated regions after the surgical reconstruction.

The Ontario Uterine Fibroid Embolization Trial. Part 1. Baseline patient characteristics, fibroid burden, and impact on life ☆

OBJECTIVE To determine baseline characteristics of women undergoing uterine artery embolization (UAE) for symptomatic fibroids. DESIGN Multicenter, prospective, single-arm clinical treatment trial. SETTING Eight Ontario university and community hospitals. PATIENT(S) Five hundred fifty-five women undergoing UAE for fibroids. INTERVENTION(S) Baseline questionnaires completed before UAE. MAIN OUTCOME MEASURE(S) Questionnaires were analyzed for demographic, medical, and gynecologic histories. Fibroid symptoms, impact of symptoms, previous consultations, and treatments were also analyzed. RESULT(S) The Ontario cohort (66% white, 23% black, 11% other races) had an average age of 43. Thirty-one percent were under age 40. Most women were university educated (68%) and working outside the home (85%). Women reported heavy menstrual bleeding (80%), urinary urgency/frequency (73%), pain during intercourse (41%), and work absences (40%). They experienced fibroid-related symptoms for an average of 5 years and consulted with on average of three gynecologists before UAE. High fibroid life-impact scores were reported by 58%. Black women were significantly younger (40.7 vs. 44.0 years), more likely to experience symptoms longer (7 vs. 5 years), and more likely to undergo myomectomy before UAE (24% vs. 9%) than white women. CONCLUSION(S) Our study illustrates that large numbers of women with highly symptomatic fibroid disease are averse to surgery despite their burden of suffering and are actively seeking alternatives to hysterectomy.