Sustained Weight Loss with Vagal Nerve Blockade but Not with Sham: 18-Month Results of the ReCharge Trial

Table 4

Serious adverse events graded as surgical complications according to the Clavien-Dindo Scale through 18 months in the vBloc group.

Serious adverse event	vBloc		Grade	Rationale for grade
	Number (%) of patients	Number of events
SAEs related to device, implant/revision, or therapy
Neuroregulator malfunction	2 (1.2)	2	IIIb; (2 events)	No abdominal surgery required, replacement with skin incision in same pocket
Atelectasis	1 (0.6)	1	I	Analgesics and antiemetics required with observation
Gallbladder disease	1 (0.6)	1	IIIb	Surgery for gallbladder removal required
Emesis/vomiting	1 (0.6)	1	IIIb	Surgery to reduce and repair hiatal hernia
Pain, neuroregulator site	1 (0.6)	1	IIIb	Skin incision, removal of fibrotic tissue, and pocket expansion required
Gastric perforation	1 (0.6)	1	IVa	Life-threatening complication with ICU management
SAEs related to intra-abdominal surgery
Nausea	6 (3.7)	6	I; (6 events)	Antiemetics and observation required
Cirrhosis	1 (0.6)	1	II	Transfusion required due to bleeding from liver biopsy
Generalized ileus	1 (0.6)	1	I	Analgesics required
Intraoperative oozing	1 (0.6)	1	I	Observation only
Total grades	Grade I: 9 events (5.6% of patients)
	Grade II: 1 event (0.6% of patients)
	Grade III: 5 events (3.1% of patients)
	Grade IV: 1 event (0.6% of patients)

Cirrhosis was found during the implant procedure and the patient was not implanted with a Maestro System.