Background

Clinical trials often analyze and report outcomes from ideal settings where sites and investigators are deliberately selected, and patients have met stringent requirements to participate. These outcomes may not be seen in clinical settings. We report the initial “real-world” experience with vBloc therapy in a cohort of patients with severe obesity in 14 centers across the U.S., including surgeries performed at a VA hospital.

Methods

vBloc therapy consisting of the laparoscopic implantation of an intermittent vagal nerve neuromodulation device (vBloc®) and participation in the vBloc Achieve behavioral program was evaluated in patients with severe obesity at 6 months and 9 months after implant. vBloc therapy levels (e.g. times of active therapy, level of therapy delivered) were personalized to each patient’s needs and all follow-up protocols were determined individually by each practice. Patient outcomes were compared to those from a previous multi-institutional prospective randomized controlled trial, the ReCharge Trial.

Results

35 patients (21 (60%) female, mean age 51 ± 17 years, mean BMI 40 ± 5 kg/m2 (SD) have been implanted with vBloc, enrolled in the vBloc Achieve program and reached 6 months follow-up. 28 patients have reached their 9 month follow-up visit. There were no serious complications. At the 6 month follow up visit, the mean percent total weight loss (%TWL) was 9% ± 6% which is comparable to the vBloc ReCharge clinical trial at 9% ± 6%TWL. 80% of patients achieved a 5% or greater %TWL which is 31% improvement in responder rate when compared to 61% of patients achieving that threshold in the ReCharge trial. The mean %TWL was 11% ±5% which is comparable to the ReCharge trial mean %TWL of 12% ± 5% for the ≥5% TWL group. At the 9 month follow up visit, the mean %TWL for 28 patients was 9% ± 7% which is comparable to the ReCharge trial at 10% ± 8%. 71% of patients achieved a 5% or greater %TWL which is 24% improvement in responder rate compared to the ReCharge trial (57%). The mean % TWL was 12% ± 4% which is comparable to the vBloc ReCharge trial %TWL of 14% ±7% for the ≥5% TWL group.

Conclusions

In the short term, vBloc Therapy can achieve significant, meaningful weight loss with minimal complications in severely obese patients not enrolled in a clinical trial. These results compare favorably to those achieved in the ReCharge trial at 6 and 9 months.