A Real-World Clinical Study of 126 Patients

[Posted 19/Mar/2024]

AUDIENCE: General Surgery, Family Medicine

KEY FINDINGS: FMR is a safe and effective treatment modality for improving facial atrophic acne scars, and the number of FMR treatment sessions and pulse width are associated with clinical efficacy.

BACKGROUND: Purpose of this study is to analyze the clinical efficacy and safety of fractional microneedle radiofrequency (FMR) for facial atrophic acne scars in a real-world setting.

DETAILS: The clinical data of patients with atrophic acne scars who had received FMR therapy from February 2018 to August 2022 were retrospectively analyzed. The improvement of atrophic acne scars was assessed using the ECCA Grading Scale (échelle d'évaluation clinique des cicatrices d'acné), Global Aesthetic Improvement Scale (GAIS), and modified Manchester Scar Scale (mMSS). Adverse reactions during FMR treatment were also recorded. Univariate and multivariate logistic regression analyses were performed to evaluate the efficacy and safety of FMR for atrophic acne scars. A total of 126 patients with facial atrophic acne scars were included. A total of 590 FMR treatment sessions were accomplished, with each of 82 patients receiving 4 or more treatment sessions, and 1 receiving a maximum of 14 sessions. All patients showed improvement in symptoms after FMR treatment, with moderate to significant improvement (ECCA score reduction of 26%–100%) in 92 (73.0%) patients. As the number of treatment sessions increased, the ECCA score gradually decreased from an average of 85.6 before to 35.0 after FMR. The average scores for distortion, color, and visual analogue scale (VAS) of mMSS all showed certain reductions. The change in GAIS score indicated improvement after treatment, with minimal improvement in 16 patients (12.7%), good improvement in 57 patients (45.2%), significant improvement in 45 patients (35.7%), and optimal improvement in 8 patients (6.4%). The univariate and multivariate logistic regression analyses revealed that the long pulse width and the number of FMR treatment sessions were positively associated with clinical efficacy. Compared to the short pulse-width group (200 ms), the longer pulse-width group (300 ms) (odds ratio [OR] = 8.3, p = 0.003) and the even longer pulse-width group (400–500 ms) (OR = 52.6, p 0.001) demonstrated stronger efficacies. Patients who received more than three treatment sessions had better outcomes compared to those who received three or fewer treatment sessions (OR = 4.0, p = 0.036). All patients experienced posttreatment transient erythema, but no crusting, infection, or blister. Six cases developed grid-like erythema around 1 month posttreatment and one case experienced hyperpigmentation, both of which resolved within 1–3 months after appropriate management.

Copyright © Wiley Periodicals LLC. All rights reserved

Source: Ziwei, D., Yuan, G., Yuehong, G., et al. (2024). Efficacy and Safety of Fractional Microneedle Radiofrequency for Atrophic Acne Scars: A Real-World Clinical Study of 126 Patients. Lasers Surg. Med.. 2024; 56(2): 150-164. Published: February, 2024. DOI: 10.1002/lsm.23759.

A Comparative Study

[Posted 18/Jan/2024]

AUDIENCE: General Surgery

KEY FINDINGS: Bone-cutting mechanism and the biological influence of the laser beam and ultrasound on living tissues proved to be favorable factors for patients' pain levels and tissue swelling postoperatively independent of the longer osteotomy duration compared to conventional drilling.

BACKGROUND: There are few research works with in-depth studies and direct simultaneous comparisons of the effects on tissue reactions and patients' recovery following in vivo conventional drilling, ultrasound- and laser-assisted osteotomy in humans. The current study aims to compare bone cutting duration, pain, swelling, and trismus in patients following surgical mandible third molar extraction by bone removal using three different osteotomes-a conventional rotary device, an ultrasonic unit, and an Er:YAG laser.

DETAILS: A prospective, randomized three-group comparative clinical trial was performed. As an experimental setting for the study, an open mandible third molar surgery was chosen because osteotomy is included in its protocol. Patients were divided into three groups according to the used device for bone removal. Bone cutting time intraoperatively, facial swelling, trismus, and pain on the first, second, and third postoperative days were assessed. The statistical analyses were performed using the SPSS v. 17.0-Kolmogorov-Smirnov test, one-way ANOVA, Student's t-test, Mann-Whitney test, and x² test. Statistical results were considered significant at p < 0.05 (confidence interval of difference, 95% CI). Eighty patients (34 males and 46 females with an average age of 25.18 years) were included in the study. The average time for bone removal by the conventional low-speed device (4.95 min), by the ultrasonic unit (5.13 min), and by the Er:YAG laser (9.00 min) differed significantly (p = 0.001). The mean postoperative facial swelling showed a marked difference between the groups (p < 0.05), in favor of the laser and piezo groups. The osteotome proved to influence pain intensity not only immediately after surgery (p = 0.002), but also during the followed-up period (p = 0.001), again in favor of the two above-mentioned groups. No association was found between trismus and the osteotome used by the followed-up patients (p > 0.05).

Copyright © Wiley Periodicals LLC. All rights reserved

Source: Blagova, B., Krastev, D., and Malinova, L. (2023). Conventional Drilling Versus Ultrasound and Laser Osteotomy in Mandibular Third Molar Surgery: A Comparative Study. Lasers in Surgery and Medicine. 2023; 55(10): 862-870. Published: December, 2023. DOI: 10.1002/lsm.23730.

[Posted 24/Aug/2023]

AUDIENCE: General Surgery, Internal Medicine

KEY FINDINGS: Compared to conventional ICS, NMP can significantly reduce the incidence of EAD, RPS, and IC after DCD liver transplantation.

BACKGROUND: In this study, authors sought to assess how liver allografts preserved using portable normothermic machine perfusion (NMP) compare against those that underwent ischemic cold storage (ICS) in the setting of donation after brain death (DBD) and donation after circulatory death (DCD) liver transplantation. Compared to conventional ICS, NMP may offer a more homeostatic preservation, permit physiologic assessment of organ function, and provide opportunities for graft improvement/modification. We report a single center US experience of liver NMP.

DETAILS: A single center, retrospective analysis of collected data on 541 adult whole liver transplants from 469 DBD donors (NMP[n=58] vs ICS[n=411]) and 72 DCD donors (NMP[n=52] vs ICS[n=20]) between January 2016 and December 2022. In DBD LT, male gender (OR [95% CI]: 1.83 [1.08-3.09]) and greater than 10% macrosteatosis of the donor liver (1.85 [1.10-3.10]) were statistically significant independent risk factors of early allograft dysfunction (EAD). Donor age >40yo and cold ischemia time (CIT) >7h were independent risk factors of reperfusion syndrome (RPS). 1-year, 3-year, and 5-year incidences of ischemic cholangiopathy (IC) did not differ significantly in DBD cases between the NMP and ICS cohorts. In DCD LT, NMP was an independent protective factor against EAD (0.11 [0.03-0.46]) and RPS (0.04 [0.01-0.25]). Incidence of IC in the DCD cases at 1-year and 3-year timepoints was significantly lower in the NMP cohort (1.9% compared to 20% in the ICS group).

Copyright © Wolters Kluwer Health, Inc. All rights reserved.

Source: Yamamoto, T., Atthota, S., Agarwal, D., et al. (2023). Impact of Portable Normothermic Machine Perfusion for Liver Transplantation From Adult Deceased Donors. Annals of Surgery . Published: August, 2023. DOI: 10.1097/SLA.0000000000006032.

[Posted 28/Jul/2023]

AUDIENCE: Ob/Gyn, Oncology

KEY FINDINGS: Reflexing samples with intermediate OVA1 scores significantly decreases the false-positive rate, thereby reducing unnecessary surgical referrals.

BACKGROUND: Patients with adnexal masses suspicious for malignancy benefit from referral to oncology specialists during presurgical assessment of the mass. OVA1 is a multivariate assay using a five-biomarker panel which offers high overall and early-stage sensitivity. However, OVA1 has a high false-positive rate for benign masses. Overa, a second-generation multivariate index assay was developed to reduce the false-positive rate. The aim of the present study was to use Overa as a reflex for OVA1 and increase specificity.

DETAILS: OVA1 cut-off scores were established to place patients into three categories: low, intermediate, and high cancer risk. Samples with intermediate-risk OVA1 scores were reflexed to the Overa and defined as high or low risk. This protocol was tested with 1035 prospectively collected serum samples and validated with an independent prospectively collected sample set (N = 207). Thirty-five per cent (359) of samples had intermediate OVA1 scores. Reflexing these to Overa eliminated 58% of the false-positives and improved the overall specificity from 50% to 72%. This finding was confirmed in the independent dataset, in which the specificity increased from 56% to 73%.

Copyright © John Wiley & Sons, Inc. All rights reserved

Source: Fritsche, H. A. and Bullock, R. G. (2023). A Reflex Testing Protocol Using Two Multivariate Index Assays Improves the Risk Assessment for Ovarian Cancer in Patients With an Adnexal Mass. Intl J Gynecol Obstet.. 2023; 162(2): 485-492. Published: August, 2023. DOI: 10.1002/ijgo.14733.

[Posted 24/Jul/2023]

AUDIENCE: General Surgery, Oncology

KEY FINDINGS: Time intervals longer than 12 weeks were associated with improved TRG and systemic recurrence but may increase surgical complexity and minor morbidity.

BACKGROUND: The treatment for extraperitoneal locally advanced rectal cancer (LARC) is neoadjuvant therapy (NAT) followed by total mesorectal excision (TME). Robust evidence on the optimal time interval between NAT completion and surgery is lacking. Purpose of this study is to assess the association of time interval between NAT completion and TME with short- and long-term outcomes. It was hypothesized that longer intervals increase the pathologic complete response (pCR) rate without increasing perioperative morbidity.

DETAILS: This cohort study included patients with LARC from 6 referral centers who completed NAT and underwent TME between January 2005 and December 2020. The cohort was divided into 3 groups depending on the time interval between NAT completion and surgery: short (<=8 weeks), intermediate (>8 and <=12 weeks), and long (>12 weeks). The median follow-up duration was 33 months. Data analyses were conducted from May 1, 2021, to May 31, 2022. The inverse probability of treatment weighting method was used to homogenize the analysis groups. The primary outcome was pCR. Other histopathologic results, perioperative events, and survival outcomes constituted the secondary outcomes. Among the 1506 patients, 908 were male (60.3%), and the median (IQR) age was 68.8 (59.4-76.5) years. The short-, intermediate-, and long-interval groups included 511 patients (33.9%), 797 patients (52.9%), and 198 patients (13.1%), respectively. The overall pCR was 17.2% (259 of 1506 patients; 95% CI, 15.4%-19.2%). When compared with the intermediate-interval group, no association was observed between time intervals and pCR in short-interval (odds ratio [OR], 0.74; 95% CI, 0.55-1.01) and long-interval (OR, 1.07; 95% CI, 0.73-1.61) groups. The long-interval group was significantly associated with lower risk of bad response (tumor regression grade [TRG] 2-3; OR, 0.47; 95% CI, 0.24-0.91), systemic recurrence (hazard ratio, 0.59; 95% CI, 0.36-0.96), higher conversion risk (OR, 3.14; 95% CI, 1.62-6.07), minor postoperative complications (OR, 1.43; 95% CI, 1.04-1.97), and incomplete mesorectum (OR, 1.89; 95% CI, 1.02-3.50) when compared with the intermediate-interval group.

Copyright © American Medical Association. All Rights Reserved.

Source: Guzman, Y., Rios, J., Paredes, J., et al. (2023). Time Interval Between the End of Neoadjuvant Therapy and Elective Resection of Locally Advanced Rectal Cancer in the CRONOS Study. JAMA Surgery. Published: July, 2023. DOI: 10.1001/jamasurg.2023.2521.

Laser-Assisted Drug Delivery Of Synthetic Alpha Melanocyte Stimulating Hormone and L-tyrosine Leads To Increased Pigmentation Area and Expression Of Melanogenesis Genes In A Porcine Hypertrophic Scar Model

[Posted 10/Jul/2023]

AUDIENCE: General Surgery, Internal Medicine

KEY FINDINGS: A clinically-relevant FLSR treatment method can be combined with topical delivery of synthetic α-MSH and L-tyrosine to increase the area of pigmentation and expression of melanogenesis genes in hypopigmented HTS. LADD of L-tyrosine alone leads to increased expression of melanogenesis genes. Future studies will aim to optimize drug delivery, timing, and dosing.

BACKGROUND: One symptom of hypertrophic scar (HTS) that can develop after burn injury is dyschromia with hyper- and hypopigmentation. There are limited treatments for these conditions. Previously, we showed there is no expression of alpha melanocyte stimulating hormone (α-MSH) in hypopigmented scars, and if these melanocytes are treated with synthetic α-MSH in vitro, they respond by repigmenting. The current study tested the same hypothesis in the in vivo environment using laser-assisted drug delivery (LADD).

DETAILS: HTSs were created in red Duroc pigs. At Day 77 (pre), they were treated with CO2 fractional ablative laser (FLSR). Synthetic α-MSH was delivered as a topical solution dissolved in L-tyrosine (n = 6, treated). Control scars received LADD of L-tyrosine only (n = 2, control). Scars were treated and examined weekly through Week 4. Digital images and punch biopsies of hyper, hypo-, and normally pigmented scar and skin were collected. Digital pictures were analyzed with ImageJ by tracing the area of hyperpigmentation. Epidermal sheets were obtained from punch biopsies through dispase separation and RNA was isolated. qRT-PCR was run for melanogenesis-related genes: tyrosinase (TYR), tyrosinase-related protein-1 (TYRP1), and dopachrome tautomerase (DCT). Two-way ANOVA with multiple comparisons and Dunnett's correction compared the groups. The areas of hyperpigmentation were variable before treatment. Therefore, data is represented as fold-change where each scar was normalized to its own pre value. Within the LADD of NDP α-MSH + L-tyrosine group, hyperpigmented areas gradually increased each week, reaching 1.3-fold over pre by Week 4. At each timepoint, area of hyperpigmentation was greater in the treated versus the control (1.04 ± 0.05 vs. 0.89 ± 0.08, 1.21 ± 0.07 vs. 0.98 ± 0.24, 1.21 ± 0.08 vs. 1.04 ± 0.11, 1.28 ± 0.11 vs. 0.94 ± 0.25; fold-change from pre-). Within the treatment group, pretreatment, levels of TYR were decreased -17.76 ± 4.52 below the level of normal skin in hypopigmented scars. After 1 treatment, potentially due to laser fractionation, the levels decreased to -43.49 ± 5.52. After 2, 3, and 4 treatments, there was ever increasing levels of TYR to almost the level of normally pigmented skin (-35.74 ± 15.72, -23.25 ± 6.80, -5.52 ± 2.22 [p < 0.01, Week 4]). This pattern was also observed for TYRP1 (pre = -12.94 ± 1.82, Week 1 = -48.85 ± 13.25 [p < 0.01], Weeks 2, 3, and 4 = -34.45 ± 14.64, -28.19 ± 4.98, -6.93 ± 3.05 [p < 0.01, Week 4]) and DCT (pre = -214.95 ± 89.42, Week 1 = -487.93 ± 126.32 [p < 0.05], Weeks 2, 3, and 4 = -219.06 ± 79.33, -72.91 ± 20.45 [p < 0.001], -76.00 ± 24.26 [p < 0.001]). Similar patterns were observed for scars treated with LADD of L-tyrosine alone without NDP α-MSH. For each gene, in hyperpigmented scar, levels increased at Week 4 of treatment compared to Week 1 (p < 0.01).

Copyright © Wiley Periodicals LLC. All rights reserved.

Source: Carney, B. C., Oliver, M. A., Kurup, S., et al. (2023). Laser-Assisted Drug Delivery Of Synthetic Alpha Melanocyte Stimulating Hormone And L-tyrosine Leads To Increased Pigmentation Area And Expression Of Melanogenesis Genes In A Porcine Hypertrophic Scar Model. Lasers Surg. Med.. 2023; 55(5): 490-502. Published: July, 2023. DOI: 10.1002/lsm.23663.