Clinical Safety of Bariatric Arterial Embolization: Preliminary Results of the BEAT Obesity Trial

Abstract

Purpose To conduct a pilot prospective clinical trial to evaluate the feasibility, safety, and short-term efficacy of bariatric embolization, a recently developed endovascular procedure for the treatment of obesity, in patients with severe obesity. Materials and Methods This is an institutional review board- and U.S. Food and Drug Administration-approved prospective physician-initiated investigational device exemption study. This phase of the study ran from June 2, 2014, to August 4, 2015. Five severely obese patients (four women, one man) who were 31-49 years of age and who had a mean body mass index of 43.8 kg/m2 ± 2.9 with no clinically important comorbidities were enrolled in this study. Transarterial embolization of the gastric fundus with fluoroscopic guidance was performed with 300-500-μm Embosphere microspheres. The primary end point was 30-day adverse events (AEs). The secondary end points included short-term weight loss, serum obesity-related hormone levels, hunger and satiety assessments, and quality of life (QOL) surveys, reported up to 3 months. Simple statistics of central tendencies and variability were calculated. No hypothesis testing was performed. Results The left gastric artery, with or without the gastroepiploic artery, was embolized in five patients, with a technical success rate of 100%. There were no major AEs. There were two minor AEs-subclinical pancreatitis and a mucosal ulcer that had healed by the time of 3-month endoscopy. A hospital stay of less than 48 hours for routine supportive care was provided for three patients. Mean excess weight loss of 5.9% ± 2.4 and 9.0% ± 4.1 was noted at 1 month and at 3 months, respectively. Mean change in serum ghrelin was 8.7% ± 34.7 and -17.5% ± 29 at 1 month and 3 months, respectively. Mean changes in serum glucagon-like peptide 1 and peptide YY were 106.6% ± 208.5 and 17.8% ± 54.8 at 1 month. There was a trend toward improvement in QOL parameters. Hunger/appetite scores decreased in the first 2 weeks after the procedure and then rose without reaching preprocedure levels. Conclusion Bariatric embolization is feasible and appears to be well tolerated in severely obese patients. In this small patient cohort, it appears to induce appetite suppression and may induce weight loss. Further expansion of this study will provide more insight into the long-term safety and efficacy of bariatric embolization. © RSNA, 2017 Online supplemental material is available for this article.

Figures

Figure 1a:

Example of bariatric embolization in a 32-year-old African American woman with a starting weight of 253 lb and a starting BMI of 47.8 kg/m2. She demonstrated an 8.8-lb weight loss from the 1-week baseline, a 12-lb weight loss from baseline 2 weeks after bariatric embolization, and an 18.2-lb weight loss from baseline at 12 weeks. This represents a 12.3% of loss of excess body weight at 12 weeks and a 12-week BMI of 44.4 kg/m2. (a) Celiac angiogram obtained before bariatric embolization shows classic LGA anatomy, with the LGA arising from the proximal celiac artery (arrow). The gastroduodenal artery (arrowhead) is also seen. (b)LGA angiogram obtained before bariatric embolization shows perfusion of the fundus with an area not perfused by this vascular distribution (wedge defect, arrow). This area is supplied by the left GEA. (c)LGA angiogram obtained after distal embolization with 300–500-μm Embospheres shows devascularization of the corresponding fundal vascular territory (arrow). (d) Subselection of the left GEA via the gastroduodenal artery was performed. Left GEA angiogram shows the vascular contribution to the gastric fundus (arrow), corresponding to the wedge defect seen on the LGA angiogram. (e) After embolization with 300–500-μm Embospheres, there was devascularization of the left gastroepiploic gastric fundal distribution (arrow).

Figure 1b:

Example of bariatric embolization in a 32-year-old African American woman with a starting weight of 253 lb and a starting BMI of 47.8 kg/m2. She demonstrated an 8.8-lb weight loss from the 1-week baseline, a 12-lb weight loss from baseline 2 weeks after bariatric embolization, and an 18.2-lb weight loss from baseline at 12 weeks. This represents a 12.3% of loss of excess body weight at 12 weeks and a 12-week BMI of 44.4 kg/m2. (a) Celiac angiogram obtained before bariatric embolization shows classic LGA anatomy, with the LGA arising from the proximal celiac artery (arrow). The gastroduodenal artery (arrowhead) is also seen. (b)LGA angiogram obtained before bariatric embolization shows perfusion of the fundus with an area not perfused by this vascular distribution (wedge defect, arrow). This area is supplied by the left GEA. (c)LGA angiogram obtained after distal embolization with 300–500-μm Embospheres shows devascularization of the corresponding fundal vascular territory (arrow). (d) Subselection of the left GEA via the gastroduodenal artery was performed. Left GEA angiogram shows the vascular contribution to the gastric fundus (arrow), corresponding to the wedge defect seen on the LGA angiogram. (e) After embolization with 300–500-μm Embospheres, there was devascularization of the left gastroepiploic gastric fundal distribution (arrow).

Figure 1c:

Example of bariatric embolization in a 32-year-old African American woman with a starting weight of 253 lb and a starting BMI of 47.8 kg/m2. She demonstrated an 8.8-lb weight loss from the 1-week baseline, a 12-lb weight loss from baseline 2 weeks after bariatric embolization, and an 18.2-lb weight loss from baseline at 12 weeks. This represents a 12.3% of loss of excess body weight at 12 weeks and a 12-week BMI of 44.4 kg/m2. (a) Celiac angiogram obtained before bariatric embolization shows classic LGA anatomy, with the LGA arising from the proximal celiac artery (arrow). The gastroduodenal artery (arrowhead) is also seen. (b)LGA angiogram obtained before bariatric embolization shows perfusion of the fundus with an area not perfused by this vascular distribution (wedge defect, arrow). This area is supplied by the left GEA. (c)LGA angiogram obtained after distal embolization with 300–500-μm Embospheres shows devascularization of the corresponding fundal vascular territory (arrow). (d) Subselection of the left GEA via the gastroduodenal artery was performed. Left GEA angiogram shows the vascular contribution to the gastric fundus (arrow), corresponding to the wedge defect seen on the LGA angiogram. (e) After embolization with 300–500-μm Embospheres, there was devascularization of the left gastroepiploic gastric fundal distribution (arrow).

Figure 1d:

Example of bariatric embolization in a 32-year-old African American woman with a starting weight of 253 lb and a starting BMI of 47.8 kg/m2. She demonstrated an 8.8-lb weight loss from the 1-week baseline, a 12-lb weight loss from baseline 2 weeks after bariatric embolization, and an 18.2-lb weight loss from baseline at 12 weeks. This represents a 12.3% of loss of excess body weight at 12 weeks and a 12-week BMI of 44.4 kg/m2. (a) Celiac angiogram obtained before bariatric embolization shows classic LGA anatomy, with the LGA arising from the proximal celiac artery (arrow). The gastroduodenal artery (arrowhead) is also seen. (b)LGA angiogram obtained before bariatric embolization shows perfusion of the fundus with an area not perfused by this vascular distribution (wedge defect, arrow). This area is supplied by the left GEA. (c)LGA angiogram obtained after distal embolization with 300–500-μm Embospheres shows devascularization of the corresponding fundal vascular territory (arrow). (d) Subselection of the left GEA via the gastroduodenal artery was performed. Left GEA angiogram shows the vascular contribution to the gastric fundus (arrow), corresponding to the wedge defect seen on the LGA angiogram. (e) After embolization with 300–500-μm Embospheres, there was devascularization of the left gastroepiploic gastric fundal distribution (arrow).

Figure 1e:

Example of bariatric embolization in a 32-year-old African American woman with a starting weight of 253 lb and a starting BMI of 47.8 kg/m2. She demonstrated an 8.8-lb weight loss from the 1-week baseline, a 12-lb weight loss from baseline 2 weeks after bariatric embolization, and an 18.2-lb weight loss from baseline at 12 weeks. This represents a 12.3% of loss of excess body weight at 12 weeks and a 12-week BMI of 44.4 kg/m2. (a) Celiac angiogram obtained before bariatric embolization shows classic LGA anatomy, with the LGA arising from the proximal celiac artery (arrow). The gastroduodenal artery (arrowhead) is also seen. (b)LGA angiogram obtained before bariatric embolization shows perfusion of the fundus with an area not perfused by this vascular distribution (wedge defect, arrow). This area is supplied by the left GEA. (c)LGA angiogram obtained after distal embolization with 300–500-μm Embospheres shows devascularization of the corresponding fundal vascular territory (arrow). (d) Subselection of the left GEA via the gastroduodenal artery was performed. Left GEA angiogram shows the vascular contribution to the gastric fundus (arrow), corresponding to the wedge defect seen on the LGA angiogram. (e) After embolization with 300–500-μm Embospheres, there was devascularization of the left gastroepiploic gastric fundal distribution (arrow).

Figure 2a:

(a) Graph shows mean hunger and appetite scores before breakfast, before lunch, midafternoon, and after dinner. (b) SF-36 quality of life graph. BP = bodily pain, GH = general health, MH = mental health, PF = physical functioning, RE = role emotional, RP = role physical, SF = social role functioning, VT = vitality. (c)IWQOL quality of life graph. PD = public distress, PF = physical function, SE = self-esteem, SL = sexual life, WK = work.

Figure 2b:

(a) Graph shows mean hunger and appetite scores before breakfast, before lunch, midafternoon, and after dinner. (b) SF-36 quality of life graph. BP = bodily pain, GH = general health, MH = mental health, PF = physical functioning, RE = role emotional, RP = role physical, SF = social role functioning, VT = vitality. (c)IWQOL quality of life graph. PD = public distress, PF = physical function, SE = self-esteem, SL = sexual life, WK = work.

Figure 2c:

(a) Graph shows mean hunger and appetite scores before breakfast, before lunch, midafternoon, and after dinner. (b) SF-36 quality of life graph. BP = bodily pain, GH = general health, MH = mental health, PF = physical functioning, RE = role emotional, RP = role physical, SF = social role functioning, VT = vitality. (c)IWQOL quality of life graph. PD = public distress, PF = physical function, SE = self-esteem, SL = sexual life, WK = work.