FIRSTT study: randomized controlled trial of uterine artery embolization vs focused ultrasound surgery.

BACKGROUND: Uterine leiomyomas (fibroid tumors) cause considerable symptoms in 30-50% of women and are the leading cause of hysterectomy in the United States. Women with uterine fibroid tumors often seek uterine-preserving treatments, but comparative effectiveness trials are lacking. OBJECTIVE: The purpose of this study was to report treatment effectiveness and ovarian function after uterine artery embolization vs magnetic resonance imaging-guided focused ultrasound surgery from the Fibroid Interventions: Reducing Symptoms Today and Tomorrow study. STUDY DESIGN: The Fibroid Interventions: Reducing Symptoms Today and Tomorrow study, which is a randomized controlled trial of uterine artery embolization vs magnetic resonance imaging-guided focused ultrasound surgery, enrolled premenopausal women with symptomatic uterine fibroid tumors; women who declined randomization were enrolled in a parallel observational cohort. A comprehensive cohort design was used for outcomes analysis. Our target enrollment was 220 women, of which we achieved 41% (n=91) in the randomized and parallel arms of the trial. Primary outcome was reintervention for uterine fibroid tumors within 36 months. Secondary outcomes were change in serum anti-Müllerian hormone levels and standardized measures of fibroid symptoms, quality of life, pain, and sexual function. RESULTS: From 2010-2014, 83 women (mean age, 44.4 years) were treated in the comprehensive cohort design (43 for magnetic resonance imaging-guided focused ultrasound surgery [27 randomized]; 40 for uterine artery embolization [22 randomized]); baseline clinical and uterine characteristics were similar between treatment arms, except for higher fibroid load in the uterine artery embolization arm. The risk of reintervention was higher with magnetic resonance imaging-guided focused ultrasound surgery than uterine artery embolization (hazard ratio, 2.81; 95% confidence interval, 1.01-7.79). Uterine artery embolization showed a significantly greater absolute decrease in anti-Müllerian hormone levels at 24 months compared with magnetic resonance imaging-guided focused ultrasound surgery. Quality of life and pain scores improved in both arms but to a greater extent in the uterine artery embolization arm. Higher pretreatment anti-Müllerian hormone level and younger age at treatment increased the overall risk of reintervention. CONCLUSION: Our study demonstrates a lower reintervention rate and greater improvement in symptoms after uterine artery embolization, although some of the effectiveness may come through impairment of ovarian reserve. Both pretreatment anti-Müllerian hormone level and age are associated with risk of reintervention. CLINICAL TRIAL REGISTRATION NUMBER: NCT00995878, clinicaltrials.gov.

Prospective Study of Routine Heparin Avoidance Hemodialysis in a Tertiary Acute Care Inpatient Practice.

INTRODUCTION: Extracorporeal circuit (EC) anticoagulation with heparin is a key advance in hemodialysis (HD), but anticoagulation is problematic in inpatients at risk of bleeding. We prospectively evaluated a heparin-avoidance HD protocol, clotting of the EC circuit (CEC), impact on dialysis efficiency, and associated risk factors in our acute care inpatients who required HD (January 17, 2014 to May 31, 2015). METHODS: HD sessions without routine EC heparin were performed using airless dialysis tubing. Patients received systemic anticoagulation therapy and/or antiplatelets for non-HD indications. We observed patients for indications of CEC (interrupted HD session, circuit loss, or inability to return blood). The primary outcome was CEC. Logistic regression with generalized estimating equations assessed associations between CEC and other variables. RESULTS: HD sessions (n = 1200) were performed in 338 patients (204 with end-stage renal disease; 134 with acute kidney injury); a median session was 211 minutes (interquartile range [IQR]: 183-240 minutes); delivered dialysis dose measured by Kt/V was 1.4 (IQR: 1.2 Kt/V 1.7). Heparin in the EC was prescribed in only 4.5% of sessions; EC clotting rate was 5.2%. Determinants for CEC were temporary catheters (odds ratio [OR]: 2.8; P < 0.01), transfusions (OR: 2.4; P = 0.04), therapeutic systemic anticoagulation (OR: 0.2; P < 0.01), and antiplatelets (OR: 0.4; P < 0.01). CEC was associated with a lower delivered Kt/V (difference: 0.39; P < 0.01). Most CEC events during transfusions (71%) occurred with administration of blood products through the HD circuit. DISCUSSION: We successfully adopted heparin avoidance using airless HD tubing as our standard inpatient protocol. This protocol is feasible and safe in acute care inpatient HD. CEC rates were low and were associated with temporary HD catheters and transfusions. Antiplatelet agents and systemic anticoagulation were protective.ClinicalTrials.gov Identifier:NCT02086682.

Efficacy of 4 Years of Octreotide Long-Acting Release Therapy in Patients With Severe Polycystic Liver Disease.

OBJECTIVE: To observe the effect on total liver volume (TLV) on and off therapy in selected symptomatic patients with autosomal dominant polycystic kidney disease (ADPKD) or autosomal dominant polycystic liver disease (PLD) who received octreotide long-acting release (OctLAR) for up to 4 years. PATIENTS AND METHODS: Twenty-eight of 42 participants in a prospective 2-year clinical trial of OctLAR (40 mg monthly) consisting of double-blind, randomized (year 1) and open-label treatment (year 2) phases reenrolled in a 2-year open-label extension (OLE) study after being off OctLAR a mean of 8.3 months (original study: July 1, 2007, through June 30, 2013). Participants underwent magnetic resonance imaging at baseline, years 1 and 2, reenrollment, and study completion. Primary end point: change in TLV; secondary end points: changes in total kidney volume, glomerular filtration rate, quality of life (QoL), safety, vital signs, and laboratory parameters. RESULTS: Twenty-five participants (59.5%) completed the OLE. Off therapy, TLVs increased a mean ± SD of 3.4%±8.2% per year; after resuming therapy, TLVs decreased a mean ± SD of -4.7%±6.1% per year. Despite regrowth off treatment, overall reductions were observed, with a median (interquartile range) TLV of 4047 mL (3107-7402 mL) at baseline and 3477 (2653-7131 mL) at study completion (-13.2%; P<.001) and with improved health-related QoL. Total kidney volumes increased, and glomerular filtration rates declined from 58.2 mL/min to 54.5 mL/min (n=16) in patients with ADPKD on therapy from baseline to study completion. CONCLUSION: Therapy with OctLAR over 4 years in selected patients with symptomatic PLD arrested PLD progression, alleviating symptoms and improving health-related QoL. Discontinuation led to organ regrowth. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00426153.