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.

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.

Copyright © Wiley Periodicals LLC. All rights reserved

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.

[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.

[Posted 28/Apr/2022]

AUDIENCE: General Surgery, Family Medicine

KEY FINDINGS: PBM improves sperm motility parameters by maintaining DNA and acrosome integrity and, therefore, represents a promising new tool for assisted reproductive therapy. In particular, improving sperm motility in asthenozoospermic patients by PBM in future may contribute to increasing the chance for successful intrauterine insemination. The present trial has no clinical registration number, as only in vitro studies were performed. The study was approved by the local ethics committee and performed according to the Declaration of Helsinki.

BACKGROUND: Previous studies reported that photobiomodulation (PBM) positively affects the mitochondrial respiratory chain in sperm, resulting in improved motility and velocity. As laser settings are not yet fully established, the present study aimed at optimizing PBM on human sperm. In addition, possible side-effects of PBM on sperm DNA fragmentation level and acrosomal integrity have been analyzed.

DETAILS: A pulsed laser-probe (wavelength 655 nm, output power 25 mW/cm², impulse duration 200 nanoseconds) was used. Native fresh liquefied semen samples underwent radiation with energy doses of 0 (control), 4, 6, and 10 J/cm². Sperm parameters were assessed at 0, 30, 60, 90, and 120 minutes after radiation using a computer-assisted sperm analysis system. Motility and velocity of sperm from asthenozoospermic patients (n = 42) and normozoospermic controls (n = 22) were measured. The amount of DNA strand breaks was analyzed using ligation-mediated quantitative polymerase chain reaction in patients with asthenozoospermia (n = 18) and normozoospermia (n = 13). Post-irradiance acrosomal integrity was investigated using flow cytometry based on CD46 protein expression (n = 7). Exposure to laser energy-doses of 4 and 6 J/cm² improved sperm motility and velocity in asthenozoospermic patients. PBM exhibited no significant effect on DNA fragmentation level and expression of CD46 serving as a biomarker for acrosome integrity.

Copyright © The Authors. Wiley Periodicals LLC. All rights reserved

Source: Espey, B. T., Kielwein, K., van der Ven, H., et al. (2022). Effects of Pulsed-Wave Photobiomodulation Therapy on Human Spermatozoa. Lasers Surg. Med.. 2022; 54(4): 540-553. Published: April, 2022. DOI: 10.1002/lsm.23399.

A Retrospective Matched Cohort Trial.

[Posted 15/Apr/2022]

AUDIENCE: General Surgery

KEY FINDINGS: The present study has shown that fully ablative CO2 laser debridement has several advantages over routine sharp surgical debridement. It is superior at ameliorating wound status and reducing wound area, and it also significantly reduces the time-to-heal for chronic wounds, without causing any adverse events.

BACKGROUND: Treating chronic cutaneous wounds is challenging, and debridement is a central concept in treating them. Studies have shown that CO₂> laser debridement can control local infection and promote the wound healing process. The present study aimed to investigate the efficacy and safety of fully ablative CO₂ laser debridement compared to routine surgical debridement in the treatment of chronic wounds.

DETAILS: The retrospective cohort study was conducted on patients with chronic (>1 month) cutaneous wounds (>=1 cm2) between December 1, 2017, and December 1, 2020, in the Wound Healing Center at Shanghai Ruijin Hospital, China. Patients treated with CO₂> laser debridement with a DEKA SmartXide2 C80 (DEKA) (the CO₂> laser group) were compared with matched control patients with similar baseline characteristics who had undergone routine surgical debridement (the routine group). The primary outcome was time-to-heal (days) for chronic wounds in two groups, and secondary outcomes included the wound area and BWAT (Bates-Jensen wound assessment tool) score before treatment, and at 1, 2, 3, and 4 weeks after treatment. The study included 164 patients (82 in the CO₂> laser group and 82 matched in the routine group). The time-to-heal for patients in the CO₂> laser group (41.30 ± 17.11) was significantly shorter than that of the patients in the routine group (48.51 ± 24.32) (p = 0.015). At 3 and 4 weeks after treatment, the absolute wound area of the CO₂> laser group was significantly smaller than that of the routine group. Also, the CO₂> laser group exhibited a significantly lower relative area at 2, 3, and 4 weeks after treatment. The CO₂> laser group yielded significantly lower BWAT scores at 2, 3, and 4 weeks after treatment. Additionally, the relative BWAT score was significantly lower in the CO₂> laser group than the relative scores in the routine group at 2, 3, and 4 weeks after treatment. No adverse events related to the treatments were observed in either group during the study period.

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Source: Guan, H., Zhang, D., Ma, X., et al. (2022). Efficacy and Safety of CO₂> Laser In The Treatment Of Chronic Wounds: A Retrospective Matched Cohort Trial. Lasers Surg. Med.. 2022; 54(4): 490-501. Published: April, 2022. DOI: 10.1002/lsm.23490.