A Randomized Clinical Trial

[Posted 9/Nov/2022]

AUDIENCE: General Surgery, Family Medicine

KEY FINDINGS: Results of this trial showed that, compared with propofol, etomidate anesthesia did not increase overall major in-hospital morbidity after abdominal surgery in older patients, although it induced transient adrenocortical suppression.

BACKGROUND: Aim of this study is to test the primary hypothesis that etomidate vs propofol for anesthesia does not increase in-hospital morbidity after abdominal surgery in older patients.

DETAILS: This multicenter, parallel-group, noninferiority randomized clinical trial (Etomidate vs Propofol for In-hospital Complications [EPIC]) was conducted between August 15, 2017, and November 20, 2020, at 22 tertiary hospitals in China. Participants were aged 65 to 80 years and were scheduled for elective abdominal surgery. Patients and outcome assessors were blinded to group allocation. Data analysis followed a modified intention-to-treat principle. Primary outcome was a composite of major in-hospital postoperative complications (with a noninferiority margin of 3%). Secondary outcomes included intraoperative hemodynamic measurements; postoperative adrenocortical hormone levels; self-reported postoperative pain, nausea, and vomiting; and mortality at postoperative months 6 and 12. A total of 1944 participants were randomized, of whom 1917 (98.6%) completed the trial. Patients were randomized to the etomidate group (n = 967; mean [SD] age, 70.3 [4.0] years; 578 men [59.8%]) or propofol group (n = 950; mean [SD] age, 70.6 [4.2] years; 533 men [56.1%]). The primary end point occurred in 90 of 967 patients (9.3%) in the etomidate group and 83 of 950 patients (8.7%) in the propofol group, which met the noninferiority criterion (risk difference [RD], 0.6%; 95% CI, -1.6% to 2.7%; P = .66). In the etomidate group, mean (SD) cortisol levels were lower at the end of surgery (4.8 [2.7] µg/dL vs 6.1 [3.4] µg/dL; P < .001), and mean (SD) aldosterone levels were lower at the end of surgery (0.13 [0.05] ng/dL vs 0.15 [0.07] ng/dL; P = .02) and on postoperative day 1 (0.14 [0.04] ng/dL vs 0.16 [0.06] ng/dL; P = .001) compared with the propofol group. No difference in mortality was observed between the etomidate and propofol groups at postoperative month 6 (2.2% vs 3.0%; RD, -0.8%; 95% CI, -2.2% to 0.7%) and 12 (3.3% vs 3.9%; RD, -0.6%; 95% CI, -2.3% to 1.0%). More patients had pneumonia in the etomidate group than in the propofol group (2.0% vs 0.3%; RD, 1.7%; 95% CI, 0.7% to 2.8%; P = .001). Results were consistent in the per-protocol population.

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Source: Lu, Z., Zheng, H., Chen, Z., et al. (2022). Effect of Etomidate vs Propofol for Total Intravenous Anesthesia on Major Postoperative Complications in Older Patients: A Randomized Clinical Trial. Lasers Surg. Med.. 2022; 157(10): 888-895. Published: October, 2022. DOI: 10.1001/jamasurg.2022.3338.

A Prospective Clinical Trial

[Posted 20/Oct/2022]

AUDIENCE: General Surgery, Family Medicine

KEY FINDINGS: AuNP-mediated PTT showed noticeable efficacy and tolerability in treating wrinkles and pores in Asian skin over a 12 week-follow-up. Further studies with a longer follow-up are needed to confirm the reduction in SG activity at the parameters used.

BACKGROUND: Transdermally delivered gold nanoparticles (AuNPs) irradiated with near-infrared laser energy can create a photothermal effect within the sebaceous glands (SGs). Photothermal therapy (PTT) can be used clinically to reverse photoaging in SG-rich areas of the skin. Improvements in wrinkles and enlarged pores in Asian skin were assessed following AuNP-mediated PTT with a long-pulsed 755-nm alexandrite laser.

DETAILS: A single-arm, prospective trial was designed. Twenty Korean patients underwent three gold PTT interventions performed 4 weeks apart at laser hair-removal settings without cooling. At Week 20, changes in the wrinkle index (WI) and pore index (PI), size, and count were calculated using three-dimensional camera analyses. Overall improvements in wrinkles and pores (0-4 scale) were assessed by blinded investigators using standardized photographic comparisons. The subjects scored their satisfaction (0-10 scale) and treatment discomfort (0-10 scale). Safety data were also collected. There were significant reductions in the WI (8.3%, p < 0.01), pore size (23.1%, p = 0.035), and PI (19.9%, p = 0.034) in the periorbital areas at week 20 compared with baseline. The mean reductions in the size (22.5%, p = 0.027), count (16.5%, p = 0.048), and index (22.4%, p = 0.023) of the cheek pores were also significant. Investigators reported average scores of 3.2 ± 0.6 for improved wrinkle appearance, and 3.1 ± 0.7 for improvement in visible pores. Participants were moderately satisfied with the overall results (7.6 ± 1.8). Subjects felt moderate discomfort during treatment (4.7 ± 2.6). No serious or persistent adverse events occurred.

Copyright © Wiley Periodicals LLC. All rights reserved.

Source: Choi, Y. J., Kim, J. S., and Kim, W. S. (2022). Photothermal Therapy Using Gold Nanoparticles and A Long-Pulsed 755-Nm Alexandrite Laser To Treat Facial Photoaging In Asian Skin: A Prospective Clinical Trial. Lasers Surg. Med.. Published: October, 2022. DOI: 10.1002/lsm.23581.

A Cohort Study

[Posted 27/Jul/2022]

AUDIENCE: Internal Medicine, Cardiology

KEY FINDINGS: Postoperative AF after noncardiac surgery is associated with similar risk for thromboembolism compared with nonoperative AF. Our findings have potentially important implications for the early postsurgical and subsequent management of postoperative AF.

BACKGROUND: Postoperative atrial fibrillation (AF) after noncardiac surgery confers increased risks for ischemic stroke and transient ischemic attack (TIA). How outcomes for postoperative AF after noncardiac surgery compare with those for AF occurring outside of the operative setting is unknown. Purpose of this study is to compare the risks for ischemic stroke or TIA and other outcomes in patients with postoperative AF versus those with incident AF not associated with surgery.

DETAILS: Patients were categorized as having AF occurring within 30 days of a noncardiac surgery (postoperative AF) or having AF unrelated to surgery (nonoperative AF). The population consisted predominantly of White patients; caution should be used when extrapolating the results to more racially diverse populations. Of 4231 patients with incident AF, 550 (13%) had postoperative AF as their first-ever documented AF presentation. Over a mean follow-up of 6.3 years, 486 patients had an ischemic stroke or TIA and 2462 had subsequent AF; a total of 2565 deaths occurred. The risk for stroke or TIA was similar between those with postoperative AF and nonoperative AF (absolute risk difference [ARD] at 5 years, 0.1% [95% CI, -2.9% to 3.1%]; hazard ratio [HR], 1.01 [CI, 0.77 to 1.32]). A lower risk for subsequent AF was seen for patients with postoperative AF (ARD at 5 years, -13.4% [CI, -17.8% to -9.0%]; HR, 0.68 [CI, 0.60 to 0.77]). Finally, no difference was seen for cardiovascular death or all-cause death between patients with postoperative AF and nonoperative AF.

Copyright © American College of Physicians. All Rights Reserved.

Source: Siontis, K. C., Gersh, B. J., Weston, S. A., et al. (2022). Associations of Atrial Fibrillation After Noncardiac Surgery With Stroke, Subsequent Arrhythmia, and Death: A Cohort Study. Annals of Internal Medicine. Published: July 26, 2022. DOI: 10.7326/M22-0434.

A Prospective, Multicenter, Single-Arm Clinical Study

[Posted 7/Jul/2022]

AUDIENCE: General Surgery, Family Medicine

KEY FINDINGS: Treatment of facial rhytids with high energy, double pass HPDR as detailed herein enables a marked improvement in FWS that parallels or surpasses competing technologies. VISIA-CR analysis demonstrates additional improvements in skin quality with statistically significant quantitative improvements in brown spots and enlarged pores as well as wrinkles. Effective rhytid effacement combines with high subject satisfaction and few unanticipated adverse events for a reasonable benefit-risk ratio.

BACKGROUND: A previous multi-center clinical study of low energy (20% power), single-pass helium plasma dermal resurfacing (HPDR) showed positive results but did not fully reveal the true potential of this novel technology. A second multi-center clinical study, reported herein, was therefore undertaken to evaluate efficacy and safety of high energy (40%), double pass HPDR for treatment of facial rhytids

DETAILS: Fifty-five eligible subjects seeking improvement in facial rhytids were enrolled for study at one of four investigational sites. All subjects underwent full-face HPDR treatment. The forehead, nose, cheeks, and peri-oral treatment zones were treated at 40% power with two passes whereas the peri-orbital and jawline/mandibular zones were treated at 20% power (up to 40% for jawline/mandibular zone) and one or two passes. Photographic images of the face were captured using the VISIA-CR system. Three-month posttreatment Fitzpatrick Wrinkle and Elastosis Scale (FWS) scores were compared to baseline scores as determined by blinded independent photographic reviewers (IPRs) and study investigators. Blinded IPRs and study investigators observed a >=1-point FWS improvement in 100% of subjects with mean change in IPR FWS from baseline to the 90-day visit of -3.6 (±1.2). 96.4% of subjects indicated "improvement" in appearance at the 90-day visit utilizing the modified Global Aesthetic Improvement Scale. Evaluation of VISIA-CR data revealed statistically significant improvements in wrinkles, brown spots, and pore counts. Overall, 269 Adverse Events in 55 subjects were reported; most were mild-moderate in severity (99.3%), anticipated (86.2%), and of relatively short duration with most having resolved within 30 days (60.6%) of treatment.

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Source: Holcomb, J. D., Doolabh, V., Lin, M., et al. (2022). High Energy, Double Pass Helium Plasma Dermal Resurfacing: A Prospective, Multicenter, Single-Arm Clinical Study. Lasers Surg. Med.. 2022; 54(5): 648-662. Published: July, 2022. DOI: 10.1002/lsm.23524.

A Large Multisite Cohort Study

[Posted 6/Jun/2022]

AUDIENCE: General Surgery, Ob/Gyn

KEY FINDINGS: Although the risk for uterine perforation with IUD insertion 4 days to 6 weeks or less post partum is nearly seven times that of insertion non-post partum, perforation remains an incredibly rare event for all clinical time points. Despite a slight increased risk of perforation with breastfeeding at IUD insertion, the benefits of breastfeeding and effective contraception generally outweigh risks and should have little clinical impact. Therefore, IUD insertion timing should be based on individual desire for IUD contraception and patient convenience to assure an IUD insertion can occur. Careful follow-up of individuals at higher risk of uterine perforation is warranted.

BACKGROUND: Reports of perforation risk related to intrauterine devices (IUDs) inserted immediately post partum and among non-post-partum individuals are scarce, and previous studies with only 12-month follow-ups underestimate the risk. Breastfeeding at IUD insertion and insertion within 36 weeks post partum have been associated with increased risk of uterine perforation. The aim of these analyses was to compare the incidence and risks of IUD-related uterine perforations by non-post-partum and post-partum intervals at IUD insertion, and among post-partum individuals, to assess the impact of breastfeeding on these outcomes.

DETAILS: Performed a multisite cohort study in the USA, using electronic health records (EHR). Study sites were three health-care systems and a site that used data from a health-care information exchange. The study population included individuals who were aged 50 years or younger and had an IUD insertion between Jan 1, 2001, and April 30, 2018. Individuals were excluded if they had not been in the health-care system for at least 12 months before IUD insertion. The primary outcome for this analysis was any IUD-related uterine perforation diagnosis for the first IUD insertion in this time period. Both complete and partial IUD-related perforations were identified. Chart abstraction was done to validate EHR-based algorithms or confirm perforations. The crude rate and cumulative incidence of uterine perforation were evaluated by non-post-partum and post-partum intervals at IUD insertion in the full cohort, and by breastfeeding status in a subcohort of post-partum individuals. Cox models estimated crude and adjusted hazard ratios (aHRs). Data from 326,658 individuals in the full cohort and 94,817 individuals in the post-partum subcohort were analysed. In the full cohort, we identified 1008 uterine perforations (51.2% complete), with the 5-year cumulative incidence being the lowest in the non-post-partum group (0.29%, 95% CI 0.26-0.34). The aHR for the post-partum interval relative to non-post partum ranged from 2.73 (95% CI 1.33-5.63; 0 to 3 days post partum) to 6.71 (4.80-9.38; 4 days to >=6 weeks post partum). The post-partum subcohort of individuals with breastfeeding information had 673 uterine perforations (62% complete), with a 5-year cumulative incidence of 1.37% (95% CI 1.24-1.52) and an increased risk with breastfeeding (aHR 1.37, 95% CI 1.12-1.66).

Copyright © Elsevier Ltd. All rights reserved.

Source: Reed, S. D., Zhou, X., Ichikawa, L., et al. (2022). Intrauterine Device-related Uterine Perforation Incidence And Risk (Apex-Iud): A Large Multisite Cohort Study. The Lancet. 2022; 399(10341): 2103-2112. Published: June 4, 2022. DOI: 10.1016/S0140-6736(22)00015-0.

[Posted 20/May/2022]

AUDIENCE: General Surgery, Oncology

KEY FINDINGS: Jet injectors generate a high number of small-droplet aerosols, potentially introducing harmful effects to patients and healthcare personnel. Room ventilation and smoke evacuation are effective safety measures when chemotherapeutics are used in clinical practice.

BACKGROUND: Needle-free jet injectors are frequently used in dermatological practice. Injection-generated small-droplet aerosols could be harmful upon inhalation when chemotherapeutics, like bleomycin, are used. Here, we aim to explore jet injector-induced small-droplet aerosol formation of bleomycin in relation to air ventilation and to provide safety measures for clinical practice.

DETAILS: With a professional particle sensor, during the study measured airborne aerosol particles (0.2-10. µm) after electronic pneumatic injection (EPI), spring-loaded jet injection (SLI), and needle injection (NI) of bleomycin and saline (100 µl) on ex vivo human skin. Three levels of air ventilation were explored: no ventilation, room ventilation, and room ventilation with an additional smoke evacuator. EPI and SLI induced significant small-droplet aerosol formation compared with none after NI (0.2-1.0 µm; no ventilation). The largest bleomycin aerosol generation was observed for the smallest particles (0.2-1.0 µm) with 673.170 (528.802-789.453) aerosol particles/liter air (EPI; no ventilation). Room ventilation and smoke evacuation led to a reduction of >=99% and 100% of measured aerosols, respectively.

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Source: Bik, L., Wolkerstorfer, A., Bekkers, V., et al. (2022). Needle-free Jet Injection-Induced Small-Droplet Aerosol Formation During Intralesional Bleomycin Therapy. Lasers Surg. Med.. 2022; 54(4): 572-579. Published: April, 2022. DOI: 10.1002/lsm.23512.