Dataset Information

Multiple same day cryolipolysis treatments for the reduction of subcutaneous fat are safe and do not affect serum lipid levels or liver function tests.

ABSTRACT: Cryolipolysis is a safe and effective non-surgical procedure for reducing subcutaneous fat. It spares adjacent structures, is associated with few adverse events, and is well-tolerated by patients. Previous studies involving one or two simultaneous treatment sites have shown no effect on serum lipid levels or liver tests. The purpose of this study was to determine whether multiple same day treatments (abdomen plus both flanks) result in changes in these blood tests, and is safe.Thirty-five adult males and females underwent same-day cryolipolysis (CoolSculpting System, ZELTIQ Aesthetics) of the lower abdomen and flanks for reduction of subcutaneous fat. Serum lipids and liver tests were measured prior to treatment and at 1, 4, and 12 weeks post-treatment. Expected treatment side-effects were assessed immediately post-treatment and at the 12-week follow-up visit. Adverse events were also monitored.Treatment consisted of one cycle to the lower abdomen using a large vacuum applicator and simultaneous treatment of both flanks, one cycle each, with medium vacuum applicators .Time between the abdomen and flanks procedures was not to exceed 30 minutes.The procedures were well-tolerated by patients; expected treatment effects were in general mild or moderate, and resolved without intervention. There were no clinically meaningful changes from baseline to any subsequent time point in any serum lipid test. This was also true for all liver tests. There were no treatment-related adverse events.Multiple cycle, same day cryolipolysis treatment of the lower abdomen and both flanks is well-tolerated and safe. It does not lead to changes in serum lipids or liver tests at any of the measured time points following the procedure. Lasers Surg. Med. 49:640-644, 2017. © 2017 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals Inc.

SUBMITTER: Klein KB

PROVIDER: S-EPMC5573959 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Multiple same day cryolipolysis treatments for the reduction of subcutaneous fat are safe and do not affect serum lipid levels or liver function tests.

Klein Kenneth B KB Bachelor Eric P EP Becker Edward V EV Bowes Leyda E LE

Lasers in surgery and medicine 20170502 7

<h4>Objective</h4>Cryolipolysis is a safe and effective non-surgical procedure for reducing subcutaneous fat. It spares adjacent structures, is associated with few adverse events, and is well-tolerated by patients. Previous studies involving one or two simultaneous treatment sites have shown no effect on serum lipid levels or liver tests. The purpose of this study was to determine whether multiple same day treatments (abdomen plus both flanks) result in changes in these blood tests, and is safe. ...[more]

PMID: 28464272

Similar Datasets

Project description:Cryolipolysis has previously received FDA clearance for fat reduction in the abdomen, flanks, and thighs. There is also interest in small volume fat reduction for areas such as the chin, knees, and axilla. This article reports the results of a cryolipolysis pivotal IDE study for reduction of submental fullness.A prototype small volume vacuum applicator (CoolMini applicator, CoolSculpting System, ZELTIQ Aesthetics) was used to treat 60 subjects in the submental area. At each treatment visit, a single treatment cycle was delivered at -10°C for 60 minutes, the same temperature and duration used in current commercially-available cryolipolysis vacuum applicators. At the investigator's discretion, an optional second treatment was delivered 6 weeks after the initial treatment. The primary efficacy endpoint was 80% correct identification of baseline photographs by independent physician review. The primary safety endpoint was monitoring incidence of device- and/or procedure-related serious adverse events. Secondary endpoints included assessment of fat layer thickness by ultrasound and subject satisfaction surveys administered 12 weeks after final cryolipolysis treatment.Independent photo review from 3 blinded physicians found 91% correct identification of baseline clinical photographs. Ultrasound data indicated mean fat layer reduction of 2.0?mm. Patient questionnaires revealed 83% of subjects were satisfied, 80% would recommend submental cryolipolysis to a friend, 77% reported visible fat reduction, 77% felt that their appearance improved following the treatment, and 76% found the procedure to be comfortable. No device- or procedure-related serious adverse events were reported.The results of this clinical evaluation of 60 patients treated in a pivotal IDE study demonstrate that submental fat can be reduced safely and effectively with a small volume cryolipolysis applicator. Patient surveys revealed that submental cryolipolysis was well-tolerated, produced visible improvement in the neck contour, and generated high patient satisfaction. These study results led to FDA clearance of cryolipolysis for submental fat treatment.

Project description:Background and objectiveThe non-invasive reduction of subcutaneous abdominal fat became popular in the last decade. Radiofrequency (RF), non-contact, selective-field device Vanquish® has been developed to selectively induce deep fat tissue heating to reduce waist circumference. Our analysis evaluates immediate and sustained effects of this treatment on cardiovascular autonomic function and on selected metabolic parameters. Study design/ patients and methods: A retrospective proof-of-concept analysis of RF treatment effects was conducted in 20 individuals with metabolic syndrome, to reduce the subcutaneous abdominal fat. Four 30-minutes treatment sessions (manufacturer´s standard protocol) were performed in 1-week intervals. Vital signs, ECG, lab screening, body composition, subcutaneous fat thickness and spectral analysis of heart rate variability (HRV) have been examined before, after the 1 (st) and 4 (th) treatment, and at follow-up visits 1 month and 3 months after the treatment.ResultsThe RF treatment led to a significant reduction of abdominal circumference after the 4 (th) session (p<0.001), and during follow-up after 1 and 3 months (p<0.001 and p<0.02, resp.). There was a significant correlation (r=-0.58, p=0.007) between reduction of abdominal circumference and initial very-low frequency (VLF) spectral power at 1 month follow-up. A significant increase of cumulative spectral power in low frequency (p=0.02) and reduction in high frequency (p=0.05) band have been observed immediately (20 +14 minutes) after the treatment. On the contrary, no sustained impact on autonomic balance has been recorded 39 +18 days after the treatment. A significant correlation between the initial adiponectin values and immediate autonomic response to one treatment was observed in VLF and total spectral bands (r>0.59, p<0.04).ConclusionsOur analysis shows that the selective-field RF treatment is safe and efficient for reduction of subcutaneous abdominal fat. While the treatment increases the immediate sympathetic response of the body to deep tissue heating, no sustained change in autonomic function could be recorded at 1 month follow-up. The observed correlation between initial VLF spectral power and waist circumference reduction at follow-up, as well as the association of initial adiponectin values and immediate autonomic response to the treatment might be instrumental for decisions on body contouring strategies.

Project description:ImportancePerforming elective upper and lower endoscopic procedures on the same day is a patient-centered and less costly approach than a 2-stage approach performed on different days, when clinically appropriate. Whether this practice pattern varies based on practice setting has not been studied.ObjectivesTo estimate the rate of different-day upper and lower endoscopic procedures in 3 types of outpatient settings and investigate the factors associated with the performance of these procedures on different days.Design, setting, and participantsA retrospective analysis was conducted of Medicare claims between January 1, 2011, and June 30, 2018, for Medicare beneficiaries who underwent a pair of upper and lower endoscopic procedures performed within 90 days of each other at hospital outpatient departments (HOPDs), freestanding ambulatory surgery centers (ASCs), and physician offices.Main outcomes and measuresUndergoing an upper and a lower endoscopic procedure on different days, adjusted for patient characteristics (age, sex, race/ethnicity, residence location and region, comorbidity, and procedure indication) and physician characteristics (sex, years in practice, procedure volume, and primary specialty). Adjusted odds ratios (aORs) and 95% CIs were calculated.ResultsA total of 4 028 587 procedure pairs were identified, of which 52.5% were performed in HOPDs, 43.3% in ASCs, and 4.2% in physician offices. The rate of different-day procedures was 13.6% in HOPDs, 22.2% in ASCs, and 47.7% in physician offices. For the 7564 physicians who practiced at both HOPDs and ASCs, their different-day procedure rate changed from 14.1% at HOPDs to 19.4% at ASCs. For the 993 physicians who practiced at both HOPDs and physician offices, their different-day procedure rate changed from 15.8% at HOPDs to 37.4% at physician offices. Patients were more likely to undergo different-day procedures at physician offices and ASCs compared with HOPDs, even after adjusting for patient and physician characteristics (physician office vs HOPD: aOR, 2.02; 95% CI, 1.85-2.20; ASC vs HOPD: aOR, 1.27; 95% CI, 1.23-1.32). Older age (85-94 years vs 65-74 years: aOR, 1.10; 95% CI, 1.08-1.11; 95 years or older vs 65-74 years: aOR, 1.14; 95% CI, 1.03-1.26), black and Hispanic race/ethnicity (black: aOR, 1.15; 95% CI, 1.12-1.17; Hispanic: aOR, 1.12; 95% CI, 1.10-1.14), and residing in the Northeast region (adjusted OR, 1.32; 95% CI, 1.28-1.36) were risk factors for undergoing different-day procedures. Micropolitan location (aOR, 0.94; 95% CI, 0.92-0.96) and rural location (aOR, 0.91; 95% CI, 0.89-0.93), more comorbidities (≥5: aOR, 0.75; 95% CI, 0.74-0.76), physician's fewer years in practice (aOR, 0.84; 95% CI, 0.81-0.87), physician's higher procedure volume (aOR, 0.65; 95% CI, 0.62-0.68), and physician's specialty of general surgery (aOR, 0.86; 95% CI, 0.80-0.91) were protective factors.Conclusions and relevancePhysician offices and ASCs had much higher different-day procedure rates compared with HOPDs. This disparity may represent an opportunity for quality improvement and financial savings for common endoscopic procedures.

Dataset Information

Multiple same day cryolipolysis treatments for the reduction of subcutaneous fat are safe and do not affect serum lipid levels or liver function tests.

Publications

Multiple same day cryolipolysis treatments for the reduction of subcutaneous fat are safe and do not affect serum lipid levels or liver function tests.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets