Treating multiple body parts for skin laxity and fat deposits using a novel focused radiofrequency device with an ultrasound component: Safety and efficacy study.

BACKGROUND AND OBJECTIVES: Growing demand for noninvasive skin tightening and reduction in fat results in an increasing pressure for devices with good clinical efficacy, consistency of results, and high patient comfort. The objective was to validate clinical efficacy and versatility of a novel device, which combines radiofrequency (RF) and ultrasound for treating skin laxity and fat deposits. METHODS: We treated 34 subjects with facial skin laxity and/or abundant body or arm fat deposits. Subjects were divided based on their indications. Ten subjects received treatments to the face, 7 subjects to arms, 8 subjects to thighs, and 9 subjects on abdomen. All patients received 4 treatments on a weekly basis. Photographs of patients were assessed by blinded evaluators to recognize the baseline images from the 3-month follow-up images. Patient comfort and satisfaction were evaluated using a 5-point Likert scale questionnaire. Any adverse events were recorded. RESULTS: Patient images were correctly recognized in >90% of cases in all study groups. Patient questionnaires showed overall satisfaction with the therapy course and results. On a scale of 1 to 5, the patients agreed (4.1) that they are satisfied with the results that the treatment is comfortable (4.1) and that they are satisfied with the treatment time (4.1). No adverse events were reported. CONCLUSIONS: Consistent clinical efficacy was confirmed across all the treated areas, together with high patient comfort and satisfaction. We conclude the device is a highly versatile solution that can deliver results across body parts and different indications.

Comparison of monitoring performance of Bioreactance vs. pulse contour during lung recruitment maneuvers.

INTRODUCTION: This study was designed to test the hypothesis of equivalence in cardiac output (CO) and stroke volume (SV) monitoring capabilities of two devices: non invasive transthoracic bioreactance (NICOM), and a pulse contour analysis (PICCO PC) coupled to transpulmonary thermodilution (PICCO TD). METHODS: We included consecutive patients of a single ICU following cardiac surgery. Continuous minute-by-minute hemodynamic variables obtained from NICOM and PICCO PC were recorded and compared in 20 patients at baseline, during a lung recruitment maneuver (20 cmH2O of PEEP) and following withdrawal of PEEP. PICCO TD measurements were also determined. We evaluated the accuracy of these two technologies at baseline using PICCO TD as reference and we estimated the precision by the fluctuation around the mean value (2SD/mean). Then, we assessed time response, amplitude response and reliability for detecting expected decreases when PEEP was applied. Type I and type II errors were analyzed. RESULTS: CO values (PICCO TD) ranged from 1.6 to 8.0 L.min-1. At baseline, CO values were comparable for NICOM, PICCO PC and PICCO TD: 5.0 +/- 1.2, 4.7 +/- 1.4 and 4.6 +/- 1.3 L.min.-1, respectively (NS). Limits of agreements with PICCO TD were 1.52 L.min.-1 for NICOM and 1.77 L.min.-1 for PICCO PC, NS. The 95% statistical power gives an equivalence with a threshold of 0.52 L.min.-1 for NICOM vs. PICCO PC. The CO precision was 6 +/- 3% and 6 +/- 5% for NICOM and PICCO PC, respectively, NS. When PEEP was applied, CO was reduced by 33 +/- 12%, 31 +/- 14% and 32 +/- 13%, for NICOM, PICCO PC and PICCO TD, respectively (NS). Time response was 3.2 +/- 0.7 minute for NICOM vs. 2 +/- 0.5 minute for PICCO PC (NS). SV results were comparable to those for CO. CONCLUSIONS: Although limited to 20 patients, this study has enough power to show comparable CO and SV monitoring capabilities of Bioreactance and pulse contour analysis calibrated by transpulmonary thermodilution.

Noninvasive cardiac output monitoring (NICOM): a clinical validation.

OBJECTIVE: To evaluate the clinical utility of a new device for continuous noninvasive cardiac output monitoring (NICOM) based on chest bio-reactance compared with cardiac output measured semi-continuously by thermodilution using a pulmonary artery catheter (PAC-CCO). DESIGN: Prospective, single-center study. SETTING: Intensive care unit. PATIENTS: Consecutive adult patients immediately after cardiac surgery. INTERVENTIONS: Cardiac output measurements obtained from NICOM and thermodilution were simultaneously recorded minute by minute and compared in 110 patients. We evaluated the accuracy, precision, responsiveness, and reliability of NICOM for detecting cardiac output changes. Tolerance for each of these parameters was specified prospectively. MEASUREMENTS AND RESULTS: A total of 65,888 pairs of cardiac output measurements were collected. Mean reference values for cardiac output ranged from 2.79 to 9.27 l/min. During periods of stable PAC-CCO (slope<+/-10%, 2SD/mean<20%), the correlation between NICOM and thermodilution was R=0.82; bias was +0.16+/-0.52 l/min (+4.0+/-11.3%), and relative error was 9.1%+/-7.8%. In 85% of patients the relative error was <20%. During periods of increasing output, slopes were similar with the two methods in 96% of patients and intra-class correlation was positive in 96%. Corresponding values during periods of decreasing output were 90% and 84%, respectively. Precision was always better with NICOM than with thermodilution. During hemodynamic challenges, changes were 3.1+/-3.8 min faster with NICOM (p<0.01) and amplitude of changes did not differ significantly. Finally, sensitivity of the NICOM for detecting significant directional changes was 93% and specificity was 93%. CONCLUSION: Cardiac output measured by NICOM had most often acceptable accuracy, precision, and responsiveness in a wide range of circulatory situations.