Procedural and Long-Term Outcomes of Tunneled Transvenous Leads.

BACKGROUND: Lead-related venous stenosis and occlusion can complicate the insertion or replacement of transvenous leads in patients with cardiac implantable electronic devices (CIED). A possible solution is to tunnel the lead from the contralateral vasculature to the ipsilateral generator. Procedural complications and long term outcomes remain unclear with this technique. OBJECTIVE: We sought to assess outcomes of tunneled transvenous leads. METHODS: We retrospectively identified all patients who underwent transvenous CIED lead tunneling to a contralateral pocket at our institution between 2014 and 2024. Clinical characteristics, indications for lead implant, post-operative complications and long-term outcomes were collected. RESULTS: We identified 27 patients underwent transvenous lead tunneling at our institution. Most patients were males (74%) with an average age of 68.8 ± 18.3 years old. Most patients had non-ischemic cardiomyopathy (59%) with an average ejection fraction of 29.3 ± 11.3 %. The tunneled leads were coronary sinus leads (20), followed by defibrillator leads (5) and RV pacing leads (2). Implants were primarily for device upgrade (18), lead revisions (8), or de-novo lead placement (1). No post-operative complications were seen. Patients were followed for an average of 2.2 ± 1.4 years. One tunneled defibrillator lead (3.7%) had low shock impedance 3 years after implant which was monitored and did not require an intervention. CONCLUSION: In patients with ipsilateral venous occlusion, contralateral lead tunneling appears to be an effective and safe approach to manage CIED patients with occluded ipsilateral subclavian veins.

Spontaneous fluctuation in atrial fibrillation burden and duration in patients with implantable loop monitors.

BACKGROUND: Most studies of device-detected atrial fibrillation (AF) have recommended indefinite anticoagulation once a patient crosses a particular threshold for AF duration or burden. However, durations and burdens are known to fluctuate over time, but little is known about the magnitude of spontaneous fluctuations and the potential impact on anticoagulation decisions. OBJECTIVE: To quantify spontaneous fluctuations in AF duration and burden in patients with implantable loop recorders (ILRs) METHODS: We reviewed all ILR interrogations for patients with non-permanent AF at our institution from 2018 to 2023. We excluded patients treated with rhythm control. The duration of longest AF episode at each interrogation was classified as < 6, 6-24, and > 24 h, and the AF burden reported at each interrogation was classified as < 2%, 2%-11.4%, and > 11.4%. RESULTS: Out of 156 patients, the mean age at ILR implant was 70.9 ± 12.5 years, CHA2DS2-VASc score was 4.2 ± 1.8, duration of ILR follow-up was 23.4 ± 11.2 months, and number of ILR interrogations per patient was 18.0 ± 8.9. The duration of longest AF episode at any point during follow-up was < 6 , 6-24 , and > 24 h in 110, 30, and 16 patients, respectively. Among the 30 patients with a longest AF episode of 6-24 h at some point during follow-up, out of 594 total ILR interrogations, only 75 (12%) showed a longest episode of 6-24 h. In the remaining 519 interrogations, the longest episode was < 6 h. In patients with a longest episode of > 24 h at any point during follow-up (n = 16), only 47 out of 320 total ILR interrogations (15%) showed an episode of > 24 h. When evaluating AF burden, 96, 38, and 22 patients had maximum reported AF burdens of < 2%, 2%-11.4%, and > 11.4% at any point during ILR follow-up. Among those with a maximum burden of 2%-11.4% at some point during follow-up (n = 38), out of 707 ILR interrogations, only 76 (11%) showed a burden of 2%-11.4%. In the remaining 631 interrogations, the burden was < 2%. In the 22 patients with a burden > 11.4% at some point during follow-up, only 80 out of 480 interrogations (17%) showed a burden of > 11.4%. In 65% of interrogations, the burden was < 2%. CONCLUSION: Significant, spontaneous fluctuations in AF burden and duration are common in patients with ILRs. Even in patients with AF episodes of 6-24 h or > 24 h at some point during follow-up, the vast majority of interrogations show episodes of < 6 h. Similarly, in patients with burdens of 2%-11.4% or > 11.4% at some point during follow-up, the vast majority of interrogations show burdens of < 2%. More data are needed to determine whether crossing an AF burden or duration threshold once is sufficient to merit lifelong anticoagulation or whether spontaneous fluctuations in AF burden and duration should impact anticoagulation decisions.

Safety and tolerability of tirbanibulin ointment 1% treatment on 100 cm2 of the face or scalp in patients with actinic keratosis: A phase 3 study.

Background: Tirbanibulin is approved for actinic keratosis (AK) field treatment up to 25 cm2. However, AK often affects larger areas; thus, AK treatments for larger fields are needed. Objective: Evaluate the safety and tolerability of tirbanibulin when applied to a field of approximately 100 cm2. Methods: Phase 3, multicenter, open-label, single-arm study among adult patients having a treatment field on the face or balding scalp of approximately 100 cm2 with 4-12 AKs. Patients received tirbanibulin to cover the treatment field once daily (5 consecutive days). Safety was assessed by evaluating treatment emergent adverse events and tolerability by composite score of 6 local tolerability signs (LTS). Results: A total of 105 patients were included. The most common LTS were erythema (96.1%) and flaking/scaling (84.4%), being mostly mild-to-moderate severity, and resolved/returned to or close to baseline by Day 29. The only severe LTS were erythema (5.8%) and flaking/scaling (8.7%). Most frequent treatment emergent adverse events were application site pruritus (10.5%) and application site pain (8.6%). Mean total number of AKs decreased from 7.7 AKs at baseline to 1.8 AKs at Day 57. Mean percent of change (reduction) from baseline in lesion count was 77.8% at Day 57. Limitations: No control group. No long-term follow-up. Conclusion: Safety and tolerability profiles in patients treated with tirbanibulin up to 100 cm2 were consistent with those previously reported over smaller field. Tirbanibulin could be used on a larger field (>25 cm2).

Tildrakizumab Real-World Effectiveness and Safety Over 64 Weeks in Patients With Moderate-to-Severe Plaque Psoriasis.

BACKGROUND: Tildrakizumab is a humanized anti-interleukin-23 p19 monoclonal antibody approved for the treatment of moderate-to-severe plaque psoriasis. This report describes real-world effectiveness and safety of tildrakizumab through 64 weeks of treatment. METHODS: In this Phase 4, multicenter, uncontrolled, open-label trial (NCT03718299), adults with moderate-to-severe plaque psoriasis received tildrakizumab 100 mg at weeks 0 and 4 and every 12 weeks thereafter through week 52. Effectiveness was assessed from body surface area (BSA) affected and static Physician Global Assessment (sPGA) through week 64 and Psoriasis Area and Severity Index (PASI) through week 52. Adverse events are reported. RESULTS: Of 55 patients enrolled, 45 completed the study and 36 received all doses of tildrakizumab. From baseline to week 64, mean +/- standard deviation BSA decreased by 83.1% (from 14.5 +/- 11.5 to 2.1 +/- 3.6) and sPGA by 67.6% (from 3.2 +/- 0.6 to 1.0 +/- 1.0); sPGA x BSA decreased by 89.6% (from 47.0 +/- 41.5 to 4.6 +/- 9.4; all P<0.001). PASI scores decreased compared to baseline at weeks 4, 16, 28, and 52 (P<0.001). For PASI responses at week 52 compared with baseline, 87.0% achieved greater than or equal to 75% improvement, 56.5% achieved greater than or equal to 90% improvement, and 32.6% achieved 100% improvement. Of 85 treatment-emergent adverse events in 34/55 patients, none were considered related to tildrakizumab treatment. CONCLUSIONS: Tildrakizumab treatment was effective in adult patients with moderate-to-severe plaque psoriasis in real-world settings, with no new safety signals. J Drugs Dermatol. 2024;23(8):612-618.  doi:10.36849/JDD.8217.

Long-term quality of life outcomes from a phase 4 study of tildrakizumab in patients with moderate-to-severe plaque psoriasis in a real-world setting.

BACKGROUND: Tildrakizumab is an anti-interleukin-23 p19 monoclonal antibody approved for the treatment of moderate-to-severe plaque psoriasis. This report describes final primary results of a 64-week real-world study of the effect of tildrakizumab on patients' health-related quality of life (HRQoL). MATERIALS AND METHODS: In this open-label phase 4 study (NCT03718299), patients with moderate-to-severe plaque psoriasis received tildrakizumab 100 mg at week 0, week 4, and every 12 weeks thereafter through week 52. The primary endpoint was improvement from baseline in HRQoL measured by Psychological General Well-Being Index (PGWBI) total score at weeks 28 and 52. Secondary HRQoL endpoints included change from baseline in Dermatology Life Quality Index (DLQI) score through week 64. Missing data were not imputed. RESULTS: Of 55 patients enrolled, 45 were assessed at week 64. Mean ± standard deviation (SD) total PGWBI score improved from 78.1 ± 14.1 at baseline to 85.2 ± 12.0 at week 52 (p < .001). Mean ± SD DLQI score improved from 9.4 ± 5.2 at baseline to 2.0 ± 2.6 (p < .001) at week 64 with 62.2% of patients having a DLQI score of 0 or 1 at week 64. CONCLUSIONS: Tildrakizumab improved long-term HRQoL in patients with psoriasis in a real-world setting.

Managing superior vena cava syndrome in patients with cardiac implantable electronic device leads: Strategies and considerations.

BACKGROUND: Data on transvenous (TV) lead-associated superior vena cava (SVC) syndrome are limited. The management of this problem might require a multidisciplinary approach, often involving transvenous lead extraction (TLE) followed by angioplasty and stenting. OBJECTIVE: The purpose of this study was to describe the management and outcome of TV lead-associated SVC syndrome. METHODS: We retrospectively identified patients with a diagnosis of SVC syndrome and TV leads at Emory Healthcare between 2015 and 2023. RESULTS: Fifteen patients with lead-related SVC syndrome were identified. The cohort average age was 50 years. Symptoms included swelling of the face, neck, and upper extremities (67%); shortness of breath (53%); and lightheadedness (40%). Patients had an average of 2 ± 0.7 leads crossing the SVC, with a lead dwell time of 9.8 ± 7.5 years. Thirteen patients were managed with TLE, followed by SVC stenting and angioplasty in 10 and angioplasty alone in 2; 1 patient had no intervention after TLE. One patient was managed with anticoagulation, and another had angioplasty and stenting with lead jailing. One patient experienced SVC perforation and cardiac tamponade during SVC stenting, which was managed successfully with a covered stent and pericardiocentesis. Among the 12 patients with TLE and angioplasty ± stenting, 7 underwent reimplantation of a transvenous lead. Two of those patients had symptoms recurrence, and none of the 5 patients without lead reimplantation had recurrence of symptoms. CONCLUSION: Lead-related SVC syndrome management requires a multidisciplinary approach often including TLE followed by angioplasty and stenting. Avoiding TV lead reimplantation might help reduce symptoms recurrence.

Biomarkers in Cutaneous Keratinocyte Carcinomas.

Skin cancer is the most common cancer type in the USA, with over five million annually treated cases and one in five Americans predicted to develop the disease by the age of 70. Skin cancer can be classified as melanoma or non-melanoma (NMSC), the latter including basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (SCC). Development of BCC and SCC is impacted by environmental, behavioral, and genetic risk factors and the incidence is on the rise, with the associated number of deaths surpassing those caused by melanoma, according to recent reports. Substantial morbidity is related to both BCC and SCC, including disfigurement, loss of function, and chronic pain, driving high treatment costs, and representing a heavy financial burden to patients and healthcare systems worldwide. Clinical presentations of BCC and SCC can be diverse, sometimes carrying considerable phenotypic similarities to benign lesions, and underscoring the need for the development of disease-specific biomarkers. Skin biomarker profiling plays an important role in deeper disease understanding, as well as in guiding clinical diagnosis and patient management, prompting the use of both invasive and non-invasive tools to evaluate specific biomarkers. In this work, we review the known and emerging biomarkers of BCC and SCC, with a focus on molecular and histologic biomarkers relevant for aspects of patient management, including prevention/risk assessments, tumor diagnosis, and therapy selection.

Developing a questionnaire for assessing clinician- and patient-reported outcomes in actinic keratosis: Results from an expert panel.

Background: Current assessments on topical treatment attributes in actinic keratosis (AK) do not evaluate safety, effectiveness, and satisfaction from both clinician and patient perspectives, creating an unmet need for more comprehensive AK-specific measures that fully capture the patient experience. Objective: To develop an actinic keratosis-specific expert panel questionnaire (AK-EPQ) of patient-reported outcomes and clinician-reported outcomes for use in research studies. Methods: Using interviews of patients with AK and targeted literature reviews, a 9-person consensus panel of dermatologists with expertise in AK treatment was convened to develop the AK-EPQ to assess AK-specific patient-reported outcomes and clinician-reported outcomes. Results: Nine expert advisers achieved consensus on 11 AK-EPQ items that encompass patient and clinician perspectives of treatment-related local skin reactions, clinical and cosmetic outcomes associated with AK, and satisfaction with treatment; the AK-EPQ will be first implemented in the Patient-Reported Outcomes for Actinic Keratosis study (NCT05260073). Limitations: The AK-EPQ does not directly measure quality of life, although it can be used with validated quality of life instruments. Conclusion: The newly developed AK-EPQ elicits insights into the patient and clinician experience with AK treatments. Comparative probing of these perspectives may help optimize precision medicine in AK treatment.

Topical Clindamycin in the Management of Acne Vulgaris: Current Perspectives and Recent Therapeutic Advances.

Clindamycin is a lincosamide-derivate antibiotic that has been widely used both systemically and topically for approximately 5 decades. The antimicrobial profile of clindamycin primarily covers several gram-positive bacteria and anaerobic bacteria, with multiple clinical applications supported in the literature and with widespread real-world use. Topical clindamycin has been used primarily for the treatment of acne vulgaris, with both monotherapy and combination therapy formulations available commercially. This article reviews the use of clindamycin as a topical agent with emphasis on therapy for acne vulgaris, and addresses modes of action, reported anti-inflammatory properties that may relate to therapeutic outcomes, recommendations to avoid the emergence of antibiotic-resistant bacteria, tolerability and safety considerations, and published data from clinical studies completed over a span of several years. A discussion of a newly FDA-approved triple-combination formulation is also included.  J Drugs Dermatol. 2024;23(6):438-445.     doi:10.36849/JDD.8318.

Hypothalamic-Pituitary-Adrenal Axis Response in Patients With Acne Vulgaris Treated With Clascoterone.

BACKGROUND: Clascoterone cream 1% is a topical androgen receptor inhibitor approved to treat acne vulgaris in patients =>12 years of age. This report provides details of patients who developed laboratory signs of hypothalamic-pituitary-adrenal (HPA) axis suppression without clinical signs of adrenal suppression during the clascoterone development program. METHODS: Two open-label, multicenter, Phase 2 trials evaluated HPA axis suppression in patients with moderate-to-severe acne vulgaris. Study 1 (NCT01831960) enrolled cohorts of adults =>18 years of age and adolescents =>12 to <18 years of age. Study 2 (NCT02720627) enrolled adolescents 9 to <12 years of age. Patients applied clascoterone twice daily at maximum-exposure dosages for 14 days. Adrenal suppression was evaluated via cosyntropin stimulation test (CST) at baseline and day 14. Patients with an abnormal CST result (serum cortisol level =<18 µg/dL) had a follow-up CST approximately 4 weeks later. Blood was collected for pharmacokinetic analysis. Other safety assessments included adverse events (AEs), physical examination/vital signs, and electrocardiography. RESULTS: Overall, 5/69 clascoterone-treated patients had an abnormal CST result on day 14, including 1/20 adults, 2/22 patients aged =>12 to <18 years, and 2/27 patients aged 9 to <12 years. All patients had normal cortisol levels at follow-up testing approximately 4 weeks later. No relationship was observed between abnormal CST results and clascoterone plasma concentrations or the amount of study drug applied. No clinically relevant AEs or clinically significant changes in safety measures were observed in patients with adrenal suppression. CONCLUSION: Clascoterone induced laboratory evidence of mild, reversible HPA axis suppression under maximum-use exposure. J Drugs Dermatol. 2024;23(6):433-437.     doi:10.36849/JDD.7997.

Consensus Statements on the Use of Novel Formulations of Isotretinoin: A Modified Delphi Process.

Oral isotretinoin remains a mainstay of treatment for severe, recalcitrant nodular acne. Novel formulations of isotretinoin have been developed over the past decade, including lidose isotretinoin and micronized isotretinoin. It is important to understand the differences between isotretinoin formulations to help guide clinical decision-making and selection of isotretinoin therapy. This study aims to provide evidence-based consensus statements regarding the use of novel formulations of isotretinoin for the treatment of moderate-to-severe acne. The Expert Consensus Group consisted of dermatologists with expertise in the treatment of acne. Voting members met in person to conduct a modified Delphi process; a maximum of 2 rounds of voting were conducted for each consensus statement. A total of 5 statements were generated regarding the use of novel formulations of isotretinoin, addressing the efficacy, tolerability, and side effects of novel isotretinoin formulations. All 5 statements achieved agreement with high consensus. The Expert Consensus Group agrees that individualized selection of isotretinoin therapy is important to maximize efficacy and minimize side effects. Compared to generic isotretinoin, micronized isotretinoin may require lower doses to achieve sufficient plasma concentrations. With the increased bioavailability of micronized formulation, there is no need to calculate cumulative dose; instead, the general recommendation with micronized isotretinoin is to treat for at least 5 months, or longer if needed to achieve clearance. Micronized isotretinoin can be taken in the fed or fasted state and has an acceptable safety profile. J Drugs Dermatol. 2024;23(6):429-432.     doi:10.36849/JDD.7971.

Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms (VINTAGE): Deep Ablation in Inaccessible Targets.

BACKGROUND: Deep intramural ventricular tachycardia substrate targets are difficult to access, map, and ablate from endocardial and epicardial surfaces, resulting in high recurrence rates. OBJECTIVES: In this study, the authors introduce a novel approach called ventricular intramyocardial navigation for tachycardia ablation guided by electrograms (VINTAGE) to access and ablate anatomically challenging ventricular tachycardia from within the myocardium. METHODS: Guidewire/microcatheter combinations were navigated deep throughout the extravascular myocardium, accessed directly from the right ventricle cavity, in Yorkshire swine (6 naive, 1 infarcted). Devices were steered to various intramyocardial targets including the left ventricle summit, guided by fluoroscopy, unipolar electrograms, and/or electroanatomic mapping. Radiofrequency ablations were performed to characterize ablation parameters and reproducibility. Intramyocardial saline irrigation began 1 minute before ablation and continued throughout. Lesions were analyzed on cardiac magnetic resonance and necropsy. RESULTS: VINTAGE was feasible in all animals within naive and infarcted myocardium. Forty-three lesions were created, using various guidewires and power settings. Forty-one (95%) lesions were detected on cardiac magnetic resonance and 38 (88%) on necropsy; all undetected lesions resulted from intentionally subtherapeutic ablation energy (10 W). Larger-diameter guidewires yielded larger size lesions. Lesion volumes on necropsy were significantly larger at 20 W than 10 W (178 mm3 [Q1-Q3: 104-382 mm3] vs 49 mm3 [Q1-Q3: 35-93 mm3]; P = 0.02). Higher power (30 W) did not create larger lesions. Median impedance dropped with preablation irrigation by 12 Ω (Q1-Q3: 8-17 Ω), followed by a further 15-Ω (Q1-Q3: 11-19 Ω) drop during ablation. Intramyocardial navigation, ablation, and irrigation were not associated with any complications. CONCLUSIONS: VINTAGE was safe and effective at creating intramural ablation lesions in targets traditionally considered inaccessible from the endocardium and epicardium, both naive and infarcted. Intramyocardial guidewire irrigation and ablation at 20 W creates reproducibly large intramural lesions.

A cross species thermoelectric and spatiotemporal analysis of alternans in live explanted hearts using dual voltage-calcium fluorescence optical mapping.

Objective.Temperature plays a crucial role in influencing the spatiotemporal dynamics of the heart. Electrical instabilities due to specific thermal conditions typically lead to early period-doubling bifurcations and beat-to-beat alternans. These pro-arrhythmic phenomena manifest in voltage and calcium traces, resulting in compromised contractile behaviors. In such intricate scenario, dual optical mapping technique was used to uncover unexplored multi-scale and nonlinear couplings, essential for early detection and understanding of cardiac arrhythmia.Approach.We propose a methodological analysis of synchronized voltage-calcium signals for detecting alternans, restitution curves, and spatiotemporal alternans patterns under different thermal conditions, based on integral features calculation. To validate our approach, we conducted a cross-species investigation involving rabbit and guinea pig epicardial ventricular surfaces and human endocardial tissue under pacing-down protocols.Main results.We show that the proposed integral feature, as the area under the curve, could be an easily applicable indicator that may enhance the predictability of the onset and progression of cardiac alternans. Insights into spatiotemporal correlation analysis of characteristic spatial lengths across different heart species were further provided.Significance.Exploring cross-species thermoelectric features contributes to understanding temperature-dependent proarrhythmic regimes and their implications on coupled spatiotemporal voltage-calcium dynamics. The findings provide preliminary insights and potential strategies for enhancing arrhythmia detection and treatment.

Patient- and Clinician-Reported Outcomes for Tirbanibulin in Actinic Keratosis in Clinical Practice Across the United States (PROAK).

BACKGROUND: The Patient-Reported Outcomes in Actinic Keratosis (PROAK) study evaluated patient- and clinician-reported outcomes (PRO; ClinRO) during 24 weeks of follow-up among adult patients with actinic keratosis (AK) on the face or scalp who were administered tirbanibulin 1% ointment in real-world community practices in the United States.  Methods: Quality of life (QoL) was assessed by Skindex-16 at week (W) 8. Additionally, effectiveness (Investigator Global Assessment [IGA]), PRO and ClinRO (Treatment Satisfaction Questionnaire for Medication and Expert Panel Questionnaire), safety, and tolerability were assessed at W8 and W24. RESULTS: The safety population included 300 patients; the full analysis set included 290 patients (278 patients at W24). At W8, a statistically significant difference (P<0.03) was observed for Skindex-16 domains in all assessed subgroups. Clinicians and patients reported high global satisfaction (mean [SD] scores of 74.9 [23.9] and 72.0 [24.6], respectively) at W24. Overall skin appearance improved from baseline to W24 (83.6% clinicians; 78.5% patients). IGA success (IGA score of 0-1) was achieved by 71.9% of patients at W24 with a similar % at W8 (73.8%) suggesting a stable effectiveness over time. About 5% of patients reported at least one adverse event, 4% reported at least one serious adverse event and no patients reported serious adverse drug reactions. At W8, the most frequently reported local skin reactions were mild/moderate erythema (47.6%) and flaking/scaling (49.6%). CONCLUSIONS: Treatment with tirbanibulin demonstrated effectiveness in the management of AK lesions and a favorable safety and tolerability profile. Furthermore, QoL was improved as early as W8, and both patients and clinicians reported high levels of treatment satisfaction, independently of patients' characteristics. J Drugs Dermatol. 2024;23(5):338-346. doi:10.36849/JDD.8264.

Triple Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% for Acne: Efficacy and Safety from a Pooled Phase 3 Analysis.

INTRODUCTION: A three-pronged approach to acne treatment combining an antibiotic, antimicrobial, and retinoid may be more efficacious than single/double treatments while potentially reducing antibiotic resistance. This study evaluated the efficacy and safety of the first fixed-dose, triple-combination topical acne product, clindamycin 1.2%/adapalene 0.15%/benzoyl peroxide (BPO) 3.1% gel (CAB) using pooled phase 3 data. METHODS: In two identical phase 3 (N = 183; N = 180), double-blind, 12-week studies, participants aged ≥ 9 years with moderate-to-severe acne were randomized 2:1 to receive once-daily CAB or vehicle gel. Endpoints included ≥ 2-grade reduction from baseline in Evaluator's Global Severity Score and clear/almost clear skin (treatment success) and least-squares mean percent change from baseline in acne lesion counts. Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were evaluated. RESULTS: At week 12, 50.0% of participants achieved treatment success with CAB versus 22.6% with vehicle gel (P < 0.001). CAB resulted in > 70% reductions in inflammatory and noninflammatory lesions at week 12 (77.9% and 73.0%, respectively), which were significantly greater than vehicle (57.9% and 48.2%; P < 0.001, both). Most TEAEs were of mild-moderate severity, and < 3% of CAB-treated participants discontinued study/treatment because of AEs. Transient increases from baseline in scaling, erythema, itching, burning, and stinging were observed with CAB, but resolved back to or near baseline values by week 12. CONCLUSIONS: The innovative fixed-dose, triple-combination clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel was efficacious and well tolerated in children, adolescents, and adults with moderate-to-severe acne. Half of participants achieved clear/almost clear skin by 12 weeks, rates not previously seen in clinical studies of other topical acne products. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT04214639 and NCT04214652.

Sex-based outcomes of subcutaneous implantable cardioverter-defibrillator and impact of surgical technique.

BACKGROUND: Because of differences in chest wall anatomy, female patients may have higher rates of subcutaneous implantable cardioverter-defibrillator (S-ICD) pocket-related complications. OBJECTIVE: We sought to evaluate sex-based outcomes after S-ICD implantation. METHODS: Patients implanted with an S-ICD at Emory Healthcare between 2010 and 2023 were included in the analysis. Patients' clinical characteristics and post-S-ICD implantation complications were collected. RESULTS: There were 429 male patients (68%) and 199 female patients (32%) observed for a median duration of 2.3 years (0.6-4.4 years). Male and female patients had comparable rates of diabetes (28%), end-stage renal disease (29.5%), ejection fraction (30.2% ± 13.4%), and body mass index (29.1 ± 6.6 kg/m2). There was no statistical difference in the incidence of shocks between men and women (26.3% vs 20.1%; P = .09), including appropriate shocks (14.7% vs 12%; P = .98) and inappropriate shocks (11.7% vs 9.5%; P = .98). Pocket-related complications occurred in 21 patients; these included pocket infection (n = 12), wound dehiscence (n = 7), and hematoma requiring drainage (n = 2). Female patients had a significantly higher pocket-related complication rate compared with male patients (7.2% vs 2.5%; P = .016). In controlling for age, body mass index, diabetes, and end-stage renal disease, female patients had higher odds of pocket-related complications compared with male patients (odds ratio, 3.15; 95% confidence interval, 1.27-7.75). Pocket-related complications decreased after 2018 compared with before 2018 (6% vs 2.6%, P = .052), mainly driven by reduction in complications in women (12.3% vs 3.2%; P = .034) but not in men (2.8% vs 2.4%; P = 1). CONCLUSION: In this cohort of S-ICD patients, women had a higher rate of post-S-ICD pocket-related complications that could be explained by sex-based differences in anatomy.