Balancing Safety and Efficacy to Determine the Most Suitable Size of Imaging-Visible Embolic Microspheres for Bariatric Arterial Embolization in a Preclinical Model.

OBJECTIVES: To identify the most suitable size of imaging-visible embolic agents with balanced safety and efficacy for bariatric arterial embolization (BAE) in a preclinical model. MATERIALS AND METHODS: Twenty-seven pigs were divided into 3 cohorts. In Cohort I, 16 pigs were randomized to receive (n = 4 each) 40-100-µm microspheres in 1 or 2 fundal arteries, 70-340-µm radiopaque microspheres in 2 fundal arteries, or saline. In Cohort II, 3 pigs underwent renal arterial embolization with either custom-made 100-200-µm, 200-250-µm, 200-300-µm, or 300-400-µm radiopaque microspheres or Bead Block 300-500 µm with microsphere distribution assessed histologically. In Cohort III, 8 pigs underwent BAE in 2 fundal arteries with tailored 100-200-µm radiopaque microspheres (n = 5) or saline (n = 3). RESULTS: In Cohort I, no significant differences in weight or ghrelin expression were observed between BAE and control animals. Moderate-to-severe gastric ulcerations were noted in all BAE animals. In Cohort II, renal embolization with 100-200-µm microspheres occluded vessels with a mean diameter of 139 µm ± 31, which is within the lower range of actual diameters of Bead Block 300-500 µm. In Cohort III, BAE with 100-200-µm microspheres resulted in significantly lower weight gain (42.3% ± 5.7% vs 51.6% ± 2.9% at 8 weeks; P = .04), fundal ghrelin cell density (16.1 ± 6.7 vs 23.6 ± 12.6; P = .045), and plasma ghrelin levels (1,709 pg/mL ± 172 vs 4,343 pg/mL ± 1,555; P < .01) compared with controls and superficial gastric ulcers (5/5). CONCLUSIONS: In this preclinical model, tailored 100-200-µm microspheres were shown to be most suitable for BAE in terms of safety and efficacy.

Bariatric Embolization of Arteries for the Treatment of Obesity (BEAT Obesity) Trial: Results at 1 Year.

Background Bariatric embolization is a new endovascular procedure to treat patients with obesity. However, the safety and efficacy of bariatric embolization are unknown. Purpose To evaluate the safety and efficacy of bariatric embolization in severely obese adults at up to 12 months after the procedure. Materials and Methods For this prospective study (NCT0216512 on ClinicalTrials.gov ), 20 participants (16 women) aged 27-68 years (mean ± standard deviation, 44 years ± 11) with mean body mass index of 45 ± 4.1 were enrolled at two institutions from June 2014 to February 2018. Transarterial embolization of the gastric fundus was performed using 300- to 500-µm embolic microspheres. Primary end points were 30-day adverse events and weight loss at up to 12 months. Secondary end points at up to 12 months included technical feasibility, health-related quality of life (Short Form-36 Health Survey ([SF-36]), impact of weight on quality of life (IWQOL-Lite), and hunger or appetite using a visual assessment scale. Analysis of outcomes was performed by using one-sample t tests and other exploratory statistics. Results Bariatric embolization was performed successfully for all participants with no major adverse events. Eight participants had a total of 11 minor adverse events. Mean excess weight loss was 8.2% (95% confidence interval [CI]: 6.3%, 10%; P < .001) at 1 month, 11.5% (95% CI: 8.7%, 14%; P < .001) at 3 months, 12.8% (95% CI: 8.3%, 17%; P < .001) at 6 months, and 11.5% (95% CI: 6.8%, 16%; P < .001) at 12 months. From baseline to 12 months, mean SF-36 scores increased (mental component summary, from 46 ± 11 to 50 ± 10, P = .44; physical component summary, from 46 ± 8.0 to 50 ± 9.3, P = .15) and mean IWQOL-Lite scores increased from 57 ± 18 to 77 ± 18 (P < .001). Hunger or appetite decreased for 4 weeks after embolization and increased thereafter, without reaching pre-embolization levels. Conclusion Bariatric embolization is well tolerated in severely obese adults, inducing appetite suppression and weight loss for up to 12 months. Published under a CC BY-NC-ND 4.0 license. Online supplemental material is available for this article.

The MILLER banding procedure as a treatment alternative for dialysis access steal syndrome: a single institutional experience.

OBJECTIVE: To describe a single institutional experience with minimally invasive limited ligation endoluminal-assisted revision (MILLER) for treatment of dialysis access steal syndrome (DASS). MATERIALS AND METHODS: Twenty patients were retrospectively identified that underwent 30 MILLER band procedures for DASS at our institution from March 2010 to December 2014. Technical success was defined by successful creation of MILLER band with preservation of flow for hemodialysis. Clinical success was defined as complete resolution of signs and symptoms with preservation of dialysis access in a 1-month postprocedural period. Primary MILLER band patency, postintervention-assisted primary access patency, and postprocedure secondary access patency are reported. RESULTS: Technical success was achieved in all patients. Clinical success was achieved in 75% of patients after one banding procedure and in 95% of patients after two banding procedures. One patient experienced access thrombosis following the initial banding procedure which was subsequently treated and did not lead to loss of access. MILLER band patency was 83% at 1 month and 77% at 6 months. Postintervention-assisted primary patency was 95%, 93%, and 92% at 3 months, 6 months, and 1 year, respectively. Postintervention secondary patency was 86%, 68%, and 59% at 3 months, 6 months, and 1 year, respectively. CONCLUSIONS: MILLER banding offers a less-invasive alternative to surgical therapy that appears to be safe and permits preservation of dialysis access.

Tc-99m sestamibi parathyroid gland scintigraphy: added value of Tc-99m pertechnetate thyroid imaging for increasing interpretation confidence and avoiding additional testing.

PURPOSE: To evaluate the benefit of adding a pertechnetate parathyroid scan (dual-isotope imaging) in the interpretation of sestamibi dual-phase parathyroid scintigraphy. MATERIAL AND METHODS: One hundred and sixteen dual Tc-99m sestamibi (MIBI) and Tc-99m pertechnetate subtraction parathyroid studies, performed between January 2000 and February 2006, were retrospectively reviewed. Dual-phase technetium sestamibi examinations were initially interpreted, with blinding to the technetium pertechnetate findings. Subsequently, technetium pertechnetate scan findings were added, and changes in interpretation were recorded. RESULTS: By adding Tc-99m pertechnetate imaging, the interpretation of 17 scans (17/116=14.6%) was substantially altered. This included 5 scans (4%) that changed from negative to positive and 9 scans (8%) that changed from equivocal to positive, excluding ectopic tissue and directing minimally invasive surgery, without the need for further imaging, such as ultrasound, in 12% of cases. One examination changed from positive to negative. In addition, 2 scans changed from equivocal to negative, necessitating further preoperative imaging for the evaluation of additional pathology such as thyroid nodules and lymph nodes and the consideration of hyperplasia. Among the remaining 99 patients, Tc-99m pertechnetate scans may also have contributed to the diagnosis in the 66 positive Tc-99m MIBI scans by increasing confidence in the interpretation and obviating additional imaging. Ten cases remained equivocal. CONCLUSION: By adding Tc-99m pertechnetate imaging, scan interpretation was changed in 14.6% of cases, and interpretation confidence was enhanced in all but 10 remaining equivocal cases. The addition of a dual-isotope subtraction also eliminated the need for additional testing, such as ultrasound, in 12% of our cases. Increased confidence in interpretation that comes with dual-isotope subtraction may come at the cost of slight lengthening of imaging time but likely simplifies preoperative localization and decreases intraoperative time for many patients with primary hyperparathyroidism.