TBE provides sustained weight loss sans side effects in obese patients
Delhi: A recent study has found transcatheter bariatric embolotherapy (TBE) to be beneficial for obese patients. According to the sham-controlled pilot trial, TBE is safe and provides sustained weight loss among obese patients.
The results of the study were presented at the PCR e-Course, the virtual meeting of the Congress of the European Association of Percutaneous Cardiovascular Interventions (EuroPCR) 2020 by Vivek Reddy, Mount Sinai Hospital, New York City.
TBE is a minimally invasive procedure that involves the use of a custom occlusion balloon microcatheter and robotic manifold for injecting 300 to 500 µm beads to the left gastric artery. Previous preclinical and case studies have shown it to promote weight loss by reducing ghrelin -- an appetite-stimulating hormone secreted from the gastric fundus. Although bariatric surgery is highly effective, the associated morbidity and mortality limit its use to the severely obese with a body mass index (BMI) typically over 40 kg/m².
The study enrolled 44 patients aged 21 to 60 having a BMI of 35 to 55 kg/m². Those with prior bariatric surgery and a history of ulcers, type 2 diabetes, chronic aspirin or non-steroidal inflammatory use, and active Helicobacter pylori infection were excluded. A total of 40 included patients were randomly assigned to TBE or a sham procedure in which lidocaine was applied to the femoral area and propofol infused for 1 hour. The patients in the two groups were well matched having a mean age of 45 vs 46 years, weight of 110 kg vs 119 kg, and BMI of 39 kg/m² vs 40 kg/m².
Embolotherapy was performed at a single center in Prague, and, on average, took 82.3 minutes and used 127 mL of contrast, 163 Gy/cm² radiation, and 4.2 mL of microspheres. A single vessel was injected in 80% of cases. The ITT population was comprised of 19 TBE and 18 control subjects, and the per-protocol population was comprised of 15 TBE and 16 control subjects, after the exclusion of patients in whom embolotherapy was unsuccessful or incomplete or who withdrew consent.
All patients received endoscopy at baseline and 1 week, as well as an intensive 19-session lifestyle and dietary education intervention out to 6 months.
Key findings of the study include:
- At 6-month follow-up, the patients receiving the intervention had lost 7.4 kg (16.3 lbs) compared with 3.0 kg (6.6 lbs) in those randomized to a sham procedure in an intention-to-treat (ITT) analysis.
- Results were similar in a per protocol analysis (9.4 kg/20.7 lbs vs 1.9 kg/4.1 lbs).
- Weight loss after embolotherapy was sustained over 12 months, falling 7.8 kg (17.1 lbs) from baseline in the ITT population and 9.3 kg (20.5 lbs) in the per-protocol population.
- Safety events after TBE were mild nausea or vomiting.
- Five participants had minor, asymptomatic ulcers that required no additional treatment.
- Patients who underwent TBE had significant improvement in hunger scores at 6 and 12 months, compared with baseline. Similarly, quality of life improved across all six domains, including significant gains in physical function, self-esteem, and overall quality of life at both time points.
"Transcatheter bariatric embolotherapy (TBE) provides sustained weight loss without serious adverse effects among obese patients," concluded the authors.
The study was presented at the European Association of Percutaneous Cardiovascular Interventions (EuroPCR) 2020 e-Course.
