BackgroundReoperation after primary breast augmentation remains an important clinical issue.ObjectiveThe authors sought to evaluate incidence and causes of reoperation in patients who underwent primary augmentation.MethodsThis retrospective, noninterventional study conducted at 16 Canadian sites reviewed medical records and patient-completed questionnaires of women who underwent primary breast augmentation with smooth or textured Natrelle Inspira implants containing TruForm 1 or TruForm 2 gel. Patients were aged ≥22 years, received implants via inframammary fold incision, and returned for follow-up at 2 to 4 years.ResultsA total of 319 women received Inspira implants (smooth TruForm 2, n = 205; textured TruForm 2, n = 99; smooth or textured TruForm 1, n = 15). At follow-up, 30 women (9.4%) had undergone reoperation, including 19 (9.3%) in the smooth TruForm 2 subgroup and 9 (9.1%) in the textured TruForm 2 subgroup. The mean time to reoperation was 1.2 years; the risk rate for reoperation was 9.9% at 3 years. The most common reasons for reoperation were implant malposition (36.7%), capsular contracture (33.3%), and the patient’s request for a change in implant size or style (20.0%). Most women were very or somewhat satisfied with the initial surgery (89.3% overall; 90.7% smooth TruForm 2; 86.9% textured TruForm 2). Thirty-four women (10.7%) reported adverse events, including 20 (9.8%) in the smooth TruForm 2 subgroup and 14 (14.1%) in the textured TruForm 2 subgroup.ConclusionsThis analysis suggests that Natrelle Inspira TruForm 2 implants are safe when used in primary breast augmentation, resulting in low reoperation rates that are consistent with those for other breast implants.Level of Evidence: 4
Regulation of heart rate was studied in rats receiving either i.v. saline at 64 microL/min or synthetic 28-residue rat atrial natriuretic peptide (ANF) at a dose sufficient to decrease mean arterial blood pressure by 10%. Autonomic influences were deduced from steady-state heart rate responses of each group to propranolol, atropine, or propranolol and atropine combined. A multiplicative model of heart rate control was used to derive quantitatively from the data the modulation of intrinsic heart rate by sympathetic and parasympathetic mechanisms. Animals receiving ANF showed a lower heart rate than control animals. This relative bradycardia was abolished by atropine. Blocking of sympathetic effects with propranolol had no effect on basal heart rate in either group, and atropinization led to significant increases in heart rate in both groups of rats. Mathematical analysis of the results showed that the bradycardia produced by ANF was due predominantly to a reduced intrinsic heart rate and to enhanced vagal inhibition of postganglionic sympathetic activity. Parasympathetic contribution to heart rate in the absence of sympathetic activity was negligible in control rats and small during ANF. We conclude that the major influences of ANF on heart rate control are a decrease of intrinsic heart rate and enhanced parasympathetic inhibition of postganglionic presynaptic sympathetic activity.
Background The first FDA-cleared, long-lasting, minimally invasive device for improving the appearance of cellulite was recently launched in Canada as a novel, tissue stabilized–guided subcision (TS-GS) system (Cellfina, Merz North America, Inc., Raleigh, NC). Clinicians from 2 of the first Canadian sites offering this procedure were interested in evaluating treatment efficacy and patient satisfaction after its first year on the market. Objectives The authors sought to evaluate the efficacy of TS-GS and the level of patient satisfaction associated with the procedure. Methods Medical charts of female patients treated with the TS-GS system in 2017 were retrospectively analyzed at 2 Canadian centers. Measurements at baseline and 3 months posttreatment were assessed for patient satisfaction and physician-rated efficacy. Patient satisfaction was assessed using a 5-point Likert-type scale, and efficacy was evaluated through physician review of 2-deminsional and 3-dimensional photography, the Nürnberger-Müller Scale for cellulite, and the Global Assessment of Improvement Scale. Results We reviewed 25 patient charts. At month 3, 95.6% of patients were satisfied with treatment results and physician evaluations revealed that on average, patients displayed a 1-point improvement in their cellulite grades. Moreover, Global Assessment of Improvement Scale scores indicated that all patients had visible improvement in the global appearance of cellulite. No serious adverse events were observed within 3 months postprocedure. Conclusions The physician ratings, patient satisfaction, and photographic evidence support the efficacy of the TS-GS system to manage grades 1 to 3 cellulite in women’s thighs and buttocks. These findings indicate the safety of the TS-GS system. Level of Evidence: 4
Background On March 11, 2020, the World Health Organization declared the novel Coronavirus-19 (COVID-19) a worldwide pandemic, resulting in an unprecedented shift in the Canadian healthcare system, where protection of an already overloaded system became a priority; all elective surgeries and non-essential activities were ceased. With the impact being less than predicted, on May 26, 2020, elective surgeries and non-essential activities were permitted to resume. Objectives The authors sought to examine outcomes following elective aesthetic surgery and the impact on the Canadian healthcare system with the resumption of these services during the COVID-19 worldwide pandemic. Methods Data were collected in a prospective manner on consecutive patients who underwent elective plastic surgery procedures in 6 accredited ambulatory surgery facilities. Data included patient demographics, procedural characteristics, COVID-19 polymerase chain reaction (PCR) test status, airway management, and postoperative outcomes. Results A total of 368 patients underwent elective surgical procedures requiring a general anesthetic. All 368 patients who underwent surgery were negative on pre-visit screening. A COVID-19 PCR test was completed by 352 patients (95.7%) and all were negative. In the postoperative period, 7 patients (1.9%) had complications, 3 patients (0.8%) required a hospital visit, and 1 patient (0.3%) required hospital admission. No patients or healthcare providers developed COVID-19 symptoms or had a positive test for COVID-19 within 30 days of surgery. Conclusions With appropriate screening and safety precautions, elective aesthetic plastic surgery can be performed in a manner that is safe for patients and healthcare providers and with a very low risk for accelerating virus transmission within the community. Level of Evidence: 4
BACkgROUND: Breast implant-associated anaplastic large cell lymphoma (BI-ALCL) is a newly identified lymphoma arising around breast implants placed for cosmetic or reconstructive indications. Patterns of disease progression and optimal treatment strategies have not been described. METHODS: The literature was reviewed for all published cases of BI-ALCL from 1997 to November 2014, contacted corresponding authors to update clinical follow up, management, and combined data with institutional cases. A novel clinic-pathologic TNM staging system is proposed and was compared to traditional Ann Arbor staging to determine prognostic value for overall survival (OS) and progression free survival (PFS). A Prentice, Williams and Peterson (PWP) model was used to assess treatment effect on progression events. RESULTS: We identified 128 unique cases of BI-ALCL, including 91 previously reported and 37 unreported cases. Pathologic slides were available in 56 patients for pathologic staging. Average follow up was 45 months (30-217 months). The median OS was 13 years, OS rate 93% at 3-years and 89% at 5 years. 18 progression events were noted and median PFS was 13 months, with 3-year and 5-year PFS at 79.4%. Total capsulectomy with implant removal (TCIR) prolonged OS (p=0.022) and improved PFS (p=0.014), and the effect of definitive surgery was statistically significant for PFS benefit (HR 0.14 [95%, CI 0.05 to 0.46]; p=0.001). After definitive surgery, patients had 4% of risk of having events by the end of the first year while the rates were 18%, 24% and 60% when patient had radiation, chemotherapy or limited surgery. The PFS was significantly different by Ann Arbor staging (p=0.013) and by the newly proposed clinical staging (p=0.030). CONCLUSIONS: Advanced stage, presence of mass, incomplete resection, and delay in definitive surgical treatment were associated with poor OS and PFS in patients with BI-ALCL. Surgical management with definitive excision and oncologic surveillance is adequate for most patients with BI-ALCL. The role for chemotherapy, targeted immunotherapy, and/or radiation for advanced disease requires further research in larger series.
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