Faculty Bibliography

BACKGROUND:Intragastric balloons are anatomy-preserving, minimally invasive obesity therapies. Enhanced tolerance and durability could help broaden clinical adoption. We investigated the safety and efficacy of an adjustable intragastric balloon (aIGB) in adults with obesity. METHODS:In this prospective, multicentre, open-label, randomised clinical trial done at seven US sites, adults aged 22-65 years with obesity were randomly assigned (2:1) to aIGB with lifestyle intervention or lifestyle intervention alone (control) for 32 weeks. Balloon volume could be increased to facilitate weight loss or decreased for tolerability. Coprimary endpoints included mean percentage total bodyweight loss and responder rate (≥5% total bodyweight loss) at 32 weeks. We used a multiple imputed intention-to-treat population analysis. This study was registered with ClinicalTrials.gov, NCT02812160. FINDINGS/RESULTS:Between Aug 9, 2016, and Dec 7, 2018, we randomly assigned 288 patients to aIGB (n=187 [65%]) or control (n=101 [35%]) groups. Mean total bodyweight loss at 32 weeks was 15·0% (95% CI 13·9-16·1) in the aIGB group versus 3·3% (2·0-4·6) in the control group (p<0·0001). Clinical response was observed in 171 (92%) patients in the aIGB group. Adjustments to the aIGB occurred in 145 (80%) patients for weight loss plateau or intolerance. Upward volume adjustment facilitated an additional mean 5·2% total bodyweight loss. Downward volume adjustment allowed 21 (75%) patients in the aIGB group to complete the full duration of therapy. Intolerance caused early removal of the device in 31 (17%) patients. No micronutrient deficiencies were observed in the aIGB cohort. Device-related serious adverse events were observed in seven (4%) patients, without any deaths. INTERPRETATION/CONCLUSIONS:When aIGB was combined with lifestyle modification, significant weight loss was achieved and maintained for 6 months following removal. Balloon volume adjustability permitted individualised therapy, maximising weight loss and tolerance. FUNDING/BACKGROUND:Spatz Medical.

IMPORTANCE/OBJECTIVE:The cervicofacial rotation-advancement flap is commonly used for facial defects. Decreasing the rate of distal edge necrosis (DEN) encountered with this flap would help prevent complications in sensitive areas such as the eyelid, lip, and nose. OBJECTIVE:To compare the untoward occurrence of DEN between 2 surgical dissection methods for reconstructive cervicofacial rotation-advancement flaps. DESIGN, SETTING, PARTICIPANTS, AND EXPOSURE: A review was conducted of 88 patients who underwent cervicofacial flap reconstruction for Mohs ablative surgery between January 1, 2003, and June 30, 2012, by the senior author (A.A.J.). All patients had periorbital, midfacial, cervical, and/or lateral temporal/forehead defects following Mohs surgical ablation. Patients were categorized into 1 of 2 groups on the basis of the surgical technique used: subcutaneous (SC) cervicofacial elevation or deep-plane (DP) cervicofacial elevation. Subcategories of smokers and nonsmokers within each group were further reviewed. Statistical analysis of DEN between categories and subcategories was performed. RESULTS:Sixty-nine patients were in the SC group and 19 were in the DP group. The mean defect size among both groups was 14.3 cm(2). The rate of active or recent smokers was 23% in the SC group and 11% in the DP group. The rate of DEN among nonsmokers in the SC group was 23% (n = 53) compared with 0% in the 17 DP nonsmokers (P = .03). The rate of smokers with DEN in the SC group was 75% and 0% in the DP group (P = .09). The mean area of DEN in the SC group was 0.8 cm(2). CONCLUSIONS AND RELEVANCE/CONCLUSIONS:Our statistically significant data indicate that DP dissection is a superior technique for avoiding DEN in nonsmokers. We found better outcomes in smokers as well. Thus, we strongly advocate the use of the DP approach as the criterion standard in cervicofacial flap elevation. LEVEL OF EVIDENCE/METHODS:3.