Patient Satisfaction, Recommendation Rate, and Patient Comfort With an FDA-Cleared Cryolipolysis System.

Background: Cryolipolysis is a non-surgical procedure for subcutaneous fat layer reduction by controlled cooling. During the past few years, the use of cryolipolysis for non-invasive body contouring has increased significantly. Objectives: This retrospective study examines patient satisfaction, recommendation rate and patient comfort with the use of an FDA-cleared system (CoolSculpting Elite, Allergan Aesthetics, AbbVie Company, Irvine CA) for cryolipolysis at a single clinic and reports on the results. Methods: Between December 2020 and January 2022, 91 patients were treated with an FDA-cleared cryolipolysis system. To assess patient satisfaction, patients were asked to complete clinical questionnaires three months after their last treatment session. The following questions were asked: painfulness of the treatment, complications, satisfaction with the treatment, consideration of further treatment sessions, and willingness to further recommend the treatment. Results: Eighty-four percent of the 91 patients were female, and 16% were male. The average age was 45.5 years and the mean BMI was 26 kg/m2. Patients rated the treatment in terms of pain and discomfort experienced during the procedures on a scale of 1 to 5, with the value 1 representing not painful and 5 as extremely painful. 40% of the patients evaluated the procedure with 1, 38% with 2, 19% with 3, 1% with 4 and 2% with 5. With respect to satisfaction rates, 66% rated the treatment on a scale from 1 to 5 with 1, 18% with 2, 7% with 3, 7% with 4 and 3% with 5, with 1 indicating very satisfied and 5 indicating very dissatisfied. Thus, the overall level of satisfaction (the sum of scale values 1 and 2) amounts to 84%. Of 91 patients, 88% would agree to further treatment and 92% would recommend the therapy to others. All patients reported temporary tissue reactions such as swelling and redness which did not require any further treatment and were self-limiting. Serious or permanent complications did not occur. Conclusions: The results of our study show that cryolipolysis is a safe and effective method for non-surgical body contouring, providing a high degree of patient satisfaction and recommendation rate.

Global Expert Opinion on Cryolipolysis Treatment Recommendations and Considerations: A Modified Delphi Study.

Background: Cryolipolysis is an increasingly popular nonsurgical fat-reduction procedure. Published treatment guidance and adverse event (AE) management protocols are limited. Objective: A modified Delphi study aimed to establish global expert consensus on the use of CoolSculpting (Allergan Aesthetics, an AbbVie Company, Irvine, CA), a noninvasive cryolipolysis treatment system. Methods: A literature search informed survey topics for an 11-expert Delphi panel. Panelists completed an online 39-question survey. An interim panel discussion, with open-ended questions and yes/no voting, informed a second survey containing 61 statements, for which panelists rated agreement using a 5-point Likert scale. Topics included treatment outcome and responder definitions, patient evaluation and selection, treatment protocols, patient satisfaction, and AEs. Results: Panelists achieved consensus on 38 final guidelines and recommendations. They reached moderate to complete consensus on 4 statements on defining responders (ie, patients with a range of visible improvement) and 6 statements on patient factors contributing to treatment outcomes (eg, how well the applicator conforms to patient body region). Panelists defined minimum numbers of treatment cycles to achieve visible clinical outcomes for 12 body regions, with moderate to complete consensus on 31 statements. They achieved a strong to complete consensus on 7 statements about patient satisfaction (eg, importance of patient expectations, visible improvement, and before-and-after photographs). Panelists defined management strategies for AEs, with moderate to complete consensus on 15 statements. Conclusions: A modified Delphi process yielded multiple guideline recommendations for cryolipolysis, providing a needed resource for the broad range of clinicians who perform this noninvasive fat-reduction procedure.

Role of nitric oxide in the mechanism of preclamping and remote ischemic preconditioning of adipocutaneous flaps in a rat model.

The purpose of this study was to determine whether nitric oxide (NO) plays a role in the mechanism of acute ischemic preconditioning (IP). Fifty-eight male Wistar rats were divided into seven experimental groups. An extended epigastric flap was raised in one of the control groups (C, n = 8), and a 3-hr flap ischemia was induced. Another group served as a non-ischemic control (CO, n = 8). The animals of group S (n = 9) received 500 nmol/kg of Spermine/Nitric Oxide Complex (Sper/NO) intravenously 30 min prior to ischemia. The group N+P (L-NAME + preclamping, n = 8) received 10 mg/kg Nomega-Nitro-L-Arginine Methyl Ester (L-NAME) intravenously before preclamping of the flap pedicle (10-min cycle length, 30-min reperfusion). Ten mg/kg L-NAME were administered in group N+T (L-NAME + tourniquet, n = 9) before ischemia of the right hindlimb was induced using a tourniquet for 10 min after flap elevation. Flap ischemia was induced after 30 min of limb reperfusion. A similar protocol was used in the groups N+P+S (L-NAME + preclamping+Sper/NO, n = 8) and N+T+S (L-NAME + tourniquet + Sper/NO, n = 8). In both groups Sper/NO was administered 30 min prior to flap ischemia, additionally to the protocol of the groups N+P and N+T. Mean flap necrosis area was assessed on the fifth postoperative day using a planimetry software. Average flap necrosis area was 67 +/- 16 percent in the control group C, 28 +/- 13.3 percent in the non-ischemic controls (CO), 10 +/- 5.9 percent in group S, 77.5 +/- 10.2 percent in group N+P, 76 +/- 6.9 percent in group N+T, 71.5 +/- 9.4 percent in group N+P+S, and 78 +/- 9.9 percent in group N+T+S. The animals of group S and CO demonstrated a significantly lower area of flap necrosis than all other groups ( p < 0.001). No significant difference could be shown between the groups C, N+P, N+T, N+P+S and N+T+S. Group S showed a significantly lower flap necrosis area than group CO ( p < 0.01). The data showed, that NO plays an important role in the mechanism of IP since the administration of an NO-donor previous to ischemia simulates the effect of IP, while the unspecific blocking of NO synthesis by L-NAME eliminates the protective effect of flap preconditioning by preclamping as well as by remote IP. Exogenous NO application is insufficient to provide protection once the endogenous NO synthesis is blocked.

Acute remote ischemic preconditioning II: the role of nitric oxide.

The purpose of this study was to determine whether nitric oxide (NO) plays a role in the mechanism of acute "classic" as well as acute remote ischemic preconditioning (IP). Thirty-two male Wistar rats were divided into five experimental groups. The rat cremaster flap in vivo microscopy model was used for assessment of ischemia/reperfusion injury. In the control group (CG, n = 8), a 2-hr flap ischemia was induced after preparation of the cremaster muscle. The animals of group NO (n = 6) received 500 nmol/kg of the NO-donor spermine/nitric oxide complex (Sper/NO) intravenously 30 min prior to ischemia. The group LN + P (L-NAME + preclamping, n = 6) received 10 mg/kg Nomega-nitro-L-arginine methyl ester (L-NAME) intravenously before preclamping of the flap pedicle (10-min cycle length, 30-min reperfusion). L-NAME (10 mg/kg) was administered in group LN + T (L-NAME + tourniquet, n = 6) before ischemia of the right hindlimb was induced, using a tourniquet for 10 min after flap elevation. The limb was then reperfused for 30 min. Thereafter, flap ischemia was induced in each group as in group CG. In vivo microscopy was performed after 1 hr of flap reperfusion in each animal. Group NO demonstrated a significantly higher red blood cell velocity (RBV) in the first-order arterioles and capillaries, a higher capillary flow, and a decreased number of leukocytes adhering to the endothelium (stickers) of the postcapillary venules by comparison to all other groups (P < 0.05). The average capillary RBV and capillary flow were still higher in the CG than in the groups receiving L-NAME (P < 0.05). The data show that NO plays an important role in the mechanism of both acute "classic" as well as acute remote IP, since the administration of a NO-donor previous to ischemia simulates the effect of IP, whereas the nonspecific blocking of NO synthesis by L-NAME abolishes the protective effect of flap preconditioning.