An Aggressively Recurrent Squamous Cell Carcinoma of the Foot.

Squamous cell carcinoma is a malignant tumor that is most commonly found on the head and neck. The current global incidence of squamous cell carcinoma at any site is estimated to be more than 1 million cases per year, with a reported 3-year mortality rate of 30%. Recurrence of squamous cell carcinoma at any site is estimated to be 15% to 50% and has been associated with greater rates of infiltration, perineural invasion, and mortality. Recent studies have shown lower-extremity squamous cell carcinoma to be distinct from squamous cell carcinoma at any site with histologic and clinical differences. Lower-extremity squamous cell carcinoma is suggestively less aggressive and carries less risk of metastasis. However, lower-extremity squamous cell carcinoma prevalence, mortality, and recurrence rates have not been extensively studied. The present report depicts a case of recurrent squamous cell carcinoma originating in 2006 in the dorsal forefoot and provides the clinical management of subsequent recurrence episodes, with excisions from 2015 and 2020.

Significance of diabetes mellitus status in patients undergoing percutaneous left main coronary artery intervention.

BACKGROUND: Diabetes mellitus (DM) is a modifiable risk factor for patients with coronary artery disease (CAD). Treatment with insulin correlates with advanced disease and has been associated with excess cardiovascular risk, but evidence on outcomes of patients with insulin-treated DM (ITDM) undergoing left main percutaneous coronary intervention (LMPCI) remains scarce. AIMS: The aim of the presented study is to evluate the risk attributable to DM and ITDM in patients undergoing LMPCI. METHODS: We included 869 patients undergoing PCI for unprotected LMCAD. The cohort was divided into three subgroups based on diabetic status: No DM, ITDM, and Non-ITDM. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE), defined as a composite of death, spontaneous myocardial infarction (MI), or stroke at 1 year. Results were adjusted for clinically relevant baseline characteristics. RESULTS: Amongst participants, 58.7% had no DM, 25.9% non-ITDM, and 15.4% ITDM. Diabetics were younger and more likely to be female. They also exhibited higher body mass index as well as prevalence of comorbidities, including hypertension, anemia, and chronic kidney disease. The number of bifurcation lesions and stents used was similar between groups. At 1 year, when compared to no DM, ITDM (25.4% vs. 10.0%, p < 0.01) but not non-ITDM (10.8% vs. 10.0%, p = 0.94) demonstrated higher MACCE. This finding was driven by increased risk of MI. Mortality was 8.4%, 7.8%, and 17.2% for no DM, Non-ITDM, and ITDM, respectively. Results remained unchanged after adjustment. CONCLUSIONS: In a rather contemporary patient population undergoing PCI for LMCAD, ITDM but not non-ITDM was associated with higher risk of 1-year MACCE, primarily driven by MI.

Impact of sex on outcomes associated with polyvascular disease in patients after PCI.

BACKGROUND: Atherosclerosis in more than 1 vs. 1 arterial bed is associated with increased risk for major adverse cardiovascular events (MACE). This study aimed to determine whether the risk of post percutaneous coronary intervention (PCI) MACE associated with polyvascular disease (PVD) differs by sex. METHODS: We analyzed 18,721 patients undergoing PCI at a tertiary-care center between 2012 and 2019. Polyvascular disease was defined as history of peripheral artery and/or cerebrovascular disease. The primary endpoint was MACE, a composite of all-cause death, myocardial infarction, or stroke at 1 year. Multivariate Cox regression was used to adjust for differences in baseline risk between patients with PVD vs. coronary artery disease (CAD) alone and interaction testing was used to assess risk modification by sex. RESULTS: Women represented 29.2% (N = 5,467) of the cohort and were more likely to have PVD than men (21.7% vs. 16.1%; P < .001). Among both sexes, patients with PVD were older with higher prevalence of comorbidities and cardiovascular risk factors. Women with PVD had the highest MACE rate (10.0%), followed by men with PVD (7.2%), women with CAD alone (5.0%), and men with CAD alone (3.6%). Adjusted analyses revealed similar relative MACE risk associated with PVD vs. CAD alone in women and men (adjusted hazard ratio [aHR] 1.54, 95% confidence interval [CI] 1.20-1.99; P < .001 and aHR 1.31, 95% CI 1.06-1.62; P = .014, respectively; p-interaction = 0.460). CONCLUSION: Women and men derive similar excess risk of MACE from PVD after PCI. The heightened risk associated with PVD needs to be addressed with maximized use of secondary prevention in both sexes.

Change in left ventricular function and outcomes following high-risk percutaneous coronary intervention with Impella-guided hemodynamic support.

Introduction: High-risk percutaneous coronary interventions (HRPCI) are a potential treatment option for patients with reduced left ventricular ejection fraction (LVEF) and coronary artery disease. The extent to which such intervention is coupled with improvement in LVEF and associated with favorable outcomes is unknown. Methods: We aimed to characterize the incidence and correlates of LVEF improvement after Impella-guided HRPCI, and compare clinical outcomes in patients with versus without LVEF improvement. Data on consecutive patients undergoing Impella-guided HRPCI from a single center registry were analyzed. LVEF-improvement was defined as an absolute increase of LVEF of ≥10% measured at ≥30-days after intervention. The primary outcome was a composite of all-cause death, myocardial infarction or target vessel revascularization within 1-year. Results: Out of 161 consecutive patients undergoing Impella-guided HRPCI from June 2008 to December 2017, 43% (n = 70) demonstrated LVEF-improvement (baseline LVEF of 25.09 ± 6.19 to 33.30 ± 11.98 post intervention). Patients without LVEF-improvement had higher frequency of previous MI (61.5% vs. 37.1%, p = 0.0021), Q-waves on ECG (17.6% vs. 5.7%, p = 0.024) and higher SYNTAX scores (30.8 ± 17.6 vs. 25.2 ± 12.2; p = 0.043). After correction of these confounders by multivariable analysis, no significant differences were found regarding the composite endpoint in patients with versus without LVEF-improvement (34.9% vs. 38.3%; p = 0.48). Discussion: In this single-center retrospective analysis, we report the following findings. First, LVEF improvement of at least 10% was documented in over 40% of patients undergoing Impella supported high-risk PCI. Second, a history of MI, Q-waves on admission ECG, and higher baseline SYNTAX scores were independent correlates of no LVEF improvement. Third, one year rates of adverse CV events were substantial and did not vary by the presence or absence of LVEF improvement Prospective studies with longer follow-up are needed to elucidate the impact of LVEF improvement on clinical outcomes.

Stellarex Drug-Coated Balloon for the Treatment of Peripheral Artery Disease: Five-Year Results from the ILLUMENATE Pivotal Randomized Controlled Trial.

This study aimed to report the 5-year outcomes from the ILLUMENATE Pivotal randomized controlled trial of the lower dose (2 µg/mm2) Stellarex drug-coated balloon (DCB) (Philips, formerly Spectranetics Corp, Colorado Springs, Colorado) compared with percutaneous transluminal angioplasty (PTA) for the treatment of symptomatic peripheral arterial disease. Long-term safety and effectiveness data for DCBs remains limited. The ILLUMENATE Pivotal was a prospective, randomized, multi-center, single-blinded study. Patients (Rutherford Clinical Category 2 to 4) were randomized 2:1 to Stellarex DCB or PTA. Follow-up was through 60 months. In total, 300 patients were enrolled. The mean age was 68.8 ± 10.2 years. At 60 months, freedom from a primary safety event was 69.2% in the Stellarex DCB arm and 68.2% in the PTA arm (log-rank, p = 0.623). The cumulative rate of major adverse events was 41.0% compared with 44.6% (p = 0.597), respectively. Freedom from clinically-driven target lesion revascularization (CD-TLR) was 70.3% in the Stellarex DCB arm compared with 68.2% in the PTA arm (p = 0.505). Time to first CD-TLR was 768.3 ± 478.9 days compared with 613.5 ± 453.4 days, respectively (p = 0.161). Kaplan-Meier estimates of freedom from all-cause mortality were 80.1% in the Stellarex DCB arm and 80.2% in the PTA arm (log-rank, p = 0.980). In conclusion, the 5-year results of the ILLUMENATE Pivotal randomized controlled trial add to the consistent safety data from the broader ILLUMENATE clinical program. These are the first data to report the 5-year safety and efficacy of a lower dose (2 µg/mm2) DCB for the treatment of symptomatic peripheral arterial disease. Clinicaltrials.gov Registration:NCT01858428.

Inflammatory risk and clinical outcomes according to polyvascular atherosclerotic disease status in patients undergoing PCI.

BACKGROUND: Individuals suffering from polyvascular atherosclerotic disease (PolyVD) face a higher likelihood of adverse cardiovascular events. Additionally, inflammation, assessed by high-sensitivity C-reactive protein (hsCRP), affects residual risk following percutaneous coronary intervention (PCI). We aimed to explore the interplay between PolyVD and hsCRP in terms of clinical outcomes after PCI. METHODS: Patients undergoing PCI for chronic coronary disease at a tertiary center between January 2012 and February 2020 were included for the current analysis. PolyVD was defined by additional history of cerebrovascular and/or peripheral artery disease. HsCRP levels were defined as elevated when the measured baseline concentration was > 3 mg/L. The primary outcome of interest was major adverse cardiovascular events (MACE), a composite of all-cause mortality, spontaneous MI, or target vessel revascularization. RESULTS: Overall, 10,359 participants were included in the current study, with 17.4% affected by PolyVD and 82.6% included in the non-PolyVD subgroup. Patients with PolyVD had higher hsCRP levels than those without. Among the PolyVD group, a larger proportion (33.6%) exhibited elevated hsCRP compared to the non-PolyVD group (24.7%). Patients with both PolyVD and elevated hsCRP levels had significantly higher adverse event rates than all other subgroups at 1-year follow-up. Furthermore, an independent association between elevated hsCRP and MACE was observed within the PolyVD population, while this was not the case for individuals without PolyVD. CONCLUSION: A residual risk of adverse outcomes after PCI linked to inflammation appears to be present among individuals with PolyVD. This could help define further target populations for anti-inflammatory treatment options.

Cross-Seal IDE Trial: Prospective, Multicenter, Single-Arm Study of the Cross-Seal Suture-Mediated Vascular Closure Device System.

BACKGROUND: An increasing number of interventional procedures require large-sheath technology (>12F) with a favorable outcome with endovascular rather than open surgical access. However, vascular complications are a limitation for the management of these patients. This trial aimed to determine the effectiveness and safety of the Cross-Seal suture-mediated vascular closure device in obtaining hemostasis at the target limb access site following interventional procedures using 8F to 18F procedural sheaths. METHODS: The Cross-Seal IDE trial (Investigational Device Exemption) was a prospective, single-arm, multicenter study in subjects undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheaths. The primary efficacy end point was time to hemostasis at the target limb access site. The primary safety end point was freedom from major complications of the target limb access site within 30 days post procedure. RESULTS: A total of 147 subjects were enrolled between August 9, 2019, and March 12, 2020. Transcatheter aortic valve replacement was performed in 53.7% (79/147) and percutaneous endovascular abdominal/thoracic aortic aneurysm repair in 46.3% (68/147) of subjects. The mean sheath ID was 15.5±1.8 mm. The primary effectiveness end point of time to hemostasis was 0.4±1.4 minutes. An adjunctive intervention was required in 9.2% (13/142) of subjects, of which 2.1% (3/142) were surgical and 5.6% (8/142) endovascular. Technical success was achieved in 92.3% (131/142) of subjects. Freedom from major complications of the target limb access site was 94.3% (83/88). CONCLUSIONS: In selected patients undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheath, Cross-Seal suture-mediated vascular closure device achieved favorable effectiveness and safety in the closure of the large-bore arteriotomy. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03756558.

Impact of Polyvascular Disease in Patients Undergoing Unprotected Left Main Percutaneous Coronary Intervention.

Percutaneous coronary intervention (PCI) has demonstrated its safety and efficacy in treating left main (LM) coronary artery disease (CAD) in select patients. Polyvascular disease (PolyVD) is associated with adverse events in all-comers with CAD. However, there is little data examining the interplay between PolyVD and LM-PCI, which we sought to investigate in a retrospective single-center study. We included patients who underwent unprotected LM-PCI at a tertiary center from 2012 to 2019. The study population was stratified based on the presence or absence of PolyVD (i.e., medical history of cerebrovascular and/or peripheral artery disease in addition to LM-CAD). The primary outcome was major adverse cardiovascular events (MACE) combining all-cause mortality and spontaneous myocardial infarction within 1 year after index PCI. Overall, 869 patients were included, and 23.8% of the population had PolyVD. Subjects with PolyVD were older and had a greater burden of co-morbidities. After 1-year follow-up, PolyVD patients exhibited significantly higher rates of both MACE (22.8% vs 9.4%, p <0.001) and bleeding events compared with those without PolyVD. MACE was primarily driven by an increase in all-cause mortality (18.3% vs 7.1%, p <0.001). Results persisted after adjusting for confounders. In conclusion, in patients who underwent LM-PCI, the presence of PolyVD is linked to an increased risk of MACE and bleeding after 1 year of follow-up, which highlights the vulnerability of this population.

Outcomes for Patients With Chronic Limb-Threatening Ischemia After Direct and Indirect Endovascular and Surgical Revascularization: A Meta-Analysis and Systematic Review.

PURPOSE: The purpose of this review and meta-analysis is to determine the clinical outcome differences between patients with chronic limb-threatening ischemia who underwent direct versus indirect angiosome revascularization using either the surgical or endovascular approach. MATERIALS AND METHODS: The data sources used for article selection included PubMed, Embase/Medline, Cochrane reviews, and Web of Science (All studies were in English and included up to September 2023). All articles included were comparative in design, including retrospective, prospective, and randomized controlled trials that compared the clinical outcomes between direct and indirect angiosome-guided revascularization in chronic limb-threatening ischemia. A random-effects model was used to determine the measure of association between direct revascularization and amputation-free survival, wound healing, and overall survival. Publication bias was assessed with both Begg's and Egger's test, and heterogeneity was calculated using an I2. RESULTS: Data from 9 articles were analyzed and reported in this review. Direct revascularization was associated with improved amputation-free survival (odds ratio [OR]=2.632, confidence interval [CI]: 1.625, 4.265), binary wound healing (OR=2.262, CI: 1.518, 3.372), and overall survival (OR=1.757, CI: 1.176, 2.625). Time until wound healed was not associated with either direct or indirect revascularization (Standard Mean Difference [SMD]=-2.15, p=0.11). There was a low risk of bias across all studies according to the RoB 2.0 tool. CONCLUSION: Direct revascularization is associated with improved amputation-free survival, overall survival, and wound healing in chronic limb-threatening ischemic patients compared to the indirect approach. CLINICAL IMPACT: Preservation of the lower extremity is critical for preventing mortality and maintaining independence. The benefit of angiosome-guided revascularization for chronic limb-threatening ischemia remains controversial. The authors of this article aim to review the current literature and compare direct and indirect angiosome-guided intervention for preserving the lower extremity. Current findings suggest direct angiosome-guided intervention reduces amputation rates and improves survival; however, many trials neglect to address the multifactorial approach needed in wound care management.

Single Center Outcomes of Percutaneous Deep Vein Arterialization in Patients with End-Stage Peripheral Artery Disease.

Background: Peripheral artery disease (PAD) can present as chronic limb threatening ischemia (CLTI) with ischemic pain and tissue loss. Progression of distal disease can lead to a "no option" or end-stage disease without traditional open or endovascular revascularization due to lack of pedal targets. Innovations in endovascular technology allow for the use of percutaneous deep vein arterialization (pDVA) to treat patients with CLTI. Purpose: We describe our experience and technique for treating four patients with end-stage PAD with pDVA. Research Design: Four patients with end-stage PAD were followed during and after pDVA creation. Technical success, complications, wound healing, and freedom from major amputation were analyzed. Data Collection and Analysis: Patient data and outcomes were collected via chart review and at time of follow up appointments in vascular surgery clinic. Results: Technical success was 100%, without post-procedural complications, and patients were continued on antiplatelet and anticoagulation. Three patients (75%) had successful wound healing, with 2 patients healing after transmetatarsal amputation (TMA), and 1 healing a distal foot ulceration that did not require surgery. One patient had worsening ischemic breakdown of a TMA, despite re-intervention on the pDVA, which required a below knee amputation (BKA). Freedom from major amputation was 75% overall, with an average follow-up time of 410 days post-procedure (Range: 113-563 days). Conclusions: Percutaneous deep vein arterialization attempts to provide blood flow to the preserved venous bed in patients with end-stage PAD. Exploration and utilization of this technique continues to expand in the modern vascular era. This case series highlights 4 patients with end-stage PVD who underwent pDVA, with 100% procedural success, and 75% limb salvage rate.

Drug-Eluting Resorbable Scaffold versus Angioplasty for Infrapopliteal Artery Disease.

BACKGROUND: Among patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease, angioplasty has been associated with frequent reintervention and adverse limb outcomes from restenosis. The effect of the use of drug-eluting resorbable scaffolds on these outcomes remains unknown. METHODS: In this multicenter, randomized, controlled trial, 261 patients with CLTI and infrapopliteal artery disease were randomly assigned in a 2:1 ratio to receive treatment with an everolimus-eluting resorbable scaffold or angioplasty. The primary efficacy end point was freedom from the following events at 1 year: amputation above the ankle of the target limb, occlusion of the target vessel, clinically driven revascularization of the target lesion, and binary restenosis of the target lesion. The primary safety end point was freedom from major adverse limb events at 6 months and from perioperative death. RESULTS: The primary efficacy end point was observed (i.e., no events occurred) in 135 of 173 patients in the scaffold group and 48 of 88 patients in the angioplasty group (Kaplan-Meier estimate, 74% vs. 44%; absolute difference, 30 percentage points; 95% confidence interval [CI], 15 to 46; one-sided P<0.001 for superiority). The primary safety end point was observed in 165 of 170 patients in the scaffold group and 90 of 90 patients in the angioplasty group (absolute difference, -3 percentage points; 95% CI, -6 to 0; one-sided P<0.001 for noninferiority). Serious adverse events related to the index procedure occurred in 2% of the patients in the scaffold group and 3% of those in the angioplasty group. CONCLUSIONS: Among patients with CLTI due to infrapopliteal artery disease, the use of an everolimus-eluting resorbable scaffold was superior to angioplasty with respect to the primary efficacy end point. (Funded by Abbott; LIFE-BTK ClinicalTrials.gov number, NCT04227899.).

Perioperative management of infant inguinal hernia surgery; a review of the recent literature.

Inguinal hernia surgery is one of the most common electively performed surgeries in infants. The common nature of inguinal hernia combined with the high-risk population involving a predominance of preterm infants makes this a particular area of interest for those concerned with their perioperative care. Despite a large volume of literature in the area of infant inguinal hernia surgery, there remains much debate amongst anesthetists, surgeons and neonatologists regarding the optimal perioperative management of these patients. The questions asked by clinicians include; when should the surgery occur, how should the surgery be performed (open or laparoscopic), how should the anesthesia be conducted, including regional versus general anesthesia and airway devices used, and what impact does anesthesia choice have on the developing brain? There is a paucity of evidence in the literature on the concerns, priorities or goals of the parents or caregivers but clearly their opinions do and should matter. In this article we review the current clinical surgical and anesthesia practice and evidence for infants undergoing inguinal hernia surgery to help clinicians answer these questions.

Chocolate Touch Versus Lutonix Drug-Coated Balloon for Femoropopliteal Lesions in Diabetes: The Chocolate Touch Study.

BACKGROUND: The randomized Chocolate Touch Study demonstrated that in patients undergoing treatment of femoropopliteal artery lesions, the Chocolate Touch drug-coated balloon (DCB) was safe and had superior efficacy at 12 months compared with the Lutonix DCB. We report the prespecified diabetes subanalysis comparing outcomes among patients with and without diabetes mellitus (DM). METHODS: Patients with claudication or ischemic rest pain (Rutherford class 2-4) were randomized to Chocolate Touch or Lutonix DCB. The primary efficacy endpoint was DCB success defined as primary patency at 12 months (peak systolic velocity ratio <2.4 by duplex ultrasound without clinically driven target lesion revascularization in the absence of bailout stenting). The primary safety endpoint was freedom from major adverse events at 12 months, a composite of target limb-related death, major amputation, or reintervention. RESULTS: A total of 313 patients (38% DM [n=119]) were randomized to either Chocolate Touch (n=66/152) or Lutonix DCB (n=53/161). Among patients with DM, DCB success was 77.2% and 60.5% (p=0.08), and in non-DM patients, DCB success was 80% and 71.3% (p=0.2114) for the Chocolate Touch and Lutonix DCB, respectively. The primary safety endpoint was similar for both cohorts regardless of DM status (interaction test, p=0.96). CONCLUSIONS: This randomized trial demonstrated similar safety and efficacy for the treatment of femoropopliteal disease with the Chocolate Touch DCB compared with using the Lutonix DCB regardless of DM status at 12 months. CLINICAL IMPACT: This substudy of the Chocolate Touch Study demonstrated similar safety and efficacy for treatment of femoropopliteal disease of the Chocolate Touch DCB compared with the Lutonix DCB regardless of diabetes (DM) status at 12 months. Endovascular therapy has become the therapy of choice for the treatment of most symptomatic femoropopliteal lesions regardless of DM status. These results give clinicians another option when treating femoropopliteal disease in this high-risk patient population.

IVUS Improves Outcomes With SUPERA Stents for the Treatment of Superficial Femoral-Popliteal Artery Disease.

BACKGROUND: Nitinol interwoven bare metal stents represent an advancement in stent technology; however, nominal deployment remains an area of focus. Intravascular ultrasound (IVUS) has been shown to improve outcomes in both the coronary and peripheral vasculature by providing the operator with greater vessel detail; however, the use of adjunctive IVUS with nitinol bare metal stents has not been widely studied. This studies aims to determine the effect of IVUS when used adjunctively with nitinol interwoven bare metal stents in the management of femoropopliteal lesions. DESIGN: Retrospective study. METHODS: This study included a cohort of 200 consecutive patients with peripheral artery disease. All patients were treated with ≥1 Supera bare metal stent, and 91 received adjunctive IVUS imaging prior to stent deployment. Deployment conditions of nominal, compressed, and elongated were measured, and the primary clinical outcomes included target lesion reintervention, amputation, and mortality. This study also showed that 8.3 number needed to treat (NNT) patients must be treated with IVUS to avoid an additional revascularization event. RESULTS: The patients who received IVUS had a significantly greater number of nominally deployed stents (p<0.001). Patients who had IVUS imaging also had significantly lower reintervention rates compared with those who did not receive IVUS imaging (p=0.047). CONCLUSION: The IVUS and angiography decreases clinically-driven target lesion reintervention and increases nominal deployment compared with angiography alone in femoropopliteal lesions treated with interwoven bare metal nitinol stents. CLINICAL IMPACT: Endovascular surgones may conisder the adjuctive use of IVUS when using the Supera stent for the treatment of infra inguinal superficial femoral artery lesions. The adjunct use of IVUS may lead to improved sizing, vessel prep, deployment, and ultiamtely reduction in CD-TLR.

Pooled study-level analysis of randomized controlled trials analyzing the effect of negative pressure wound therapy with irrigation vs traditional negative pressure wound therapy on diabetic foot outcomes.

INTRODUCTION: The benefits of NPWT-T for the diabetic foot have been established. The addition of regular periodic irrigation with broad-spectrum antiseptic solution has been shown to reduce bioburden and total bacterial colonies; however, debate remains as to the clinical effect on diabetic foot outcomes. OBJECTIVE: This study investigated the differences between NPWT-T and NPWT-I for treatment of the diabetic foot and the associated clinical outcomes. METHODS: PubMed, Medline/Embase, the Cochrane Library, and Web of Science were searched for relevant literature published between January 1, 2002, and March 1, 2022. Keywords included "Negative Pressure Wound Therapy" AND "Instillation" OR "Irrigation." Three studies with a total of 421 patients (NPWT-T [n = 223], NPWT-I [n = 198]) were included in the meta-analysis. RESULTS: No significant differences were observed between NPWT-T and NPWT-I for BWC (OR, 1.049; 95% CI, 0.709-1.552; P =.810), time to wound closure (SMD, -0.039; 95% CI, -0.233-0.154; P =.691), LOS (SMD, 0.065; 95% CI, -0.128-0.259; P =.508), or AEs (OR, 1.092; 95% CI, 0.714-1.670; P =.69). CONCLUSION: Results of this systematic review and meta-analysis indicate that further RCTs are required to assess the role of NPWT-I in the management of DFU and DFI.

A comparison of operative and anesthetic techniques for inguinal hernia repair in infants.

BACKGROUND: Pediatric inguinal hernia repair (IHR) is increasingly performed using minimally invasive surgery (MIS) but has only recently been described using caudal block without endotracheal intubation. We evaluated the surgical outcomes and resource utilization of infants undergoing hernia repair, comparing both the operative approach (open/MIS) and anesthetic technique (general anesthesia [GA]/caudal). METHODS: All infants <1 year-of-age undergoing elective IHR without concomitant procedures from July 2016 to July 2021 at a single tertiary care teaching center were retrospectively reviewed. Eight surgeons and 25 anesthesiologists contributed patients, with approach dictated by practitioner preference. Data collected included patient demographics, surgical and anesthetic details, and operating room (OR) utilization metrics. Post-operative complications were evaluated and aggregated, including recurrent hernia, metachronous hernia, hematoma, hydrocele, testicular atrophy, and acquired cryptorchidism. Descriptive statistics were performed with R Studios (p < 0.05). RESULTS: Of the 338 patients included for analysis, most underwent an open procedure (n = 275) while anesthetic technique was evenly split between GA (n = 185) and caudal (n = 153). Most patients were male (87.6%) and born premature: mean gestational age of 31.4 ± 4.1 weeks. MIS-to-Open conversion was noted once (3.3%) in the GA MIS group, but none in caudal. Median follow up was 2.5 (1.4-3.8) years. No differences were noted in aggregate surgical complication rates (p = 0.4). The Caudal Open group had the shortest total OR time (p < 0.01); caudal anesthesia shortened post-procedure times (p < 0.01). CONCLUSION: MIS IHR performed under caudal block and sedation yields comparable complication rates compared to the open approach or GA. Open IHR with caudal blockade was the most efficient operative room utilization. TYPE OF STUDY: Original Article, Clinical Research. LEVELS OF EVIDENCE: Level III.

Revascularization Strategies for Patients With Femoropopliteal Peripheral Artery Disease.

BACKGROUND: No adequately powered studies exist to compare major clinical outcomes after endovascular therapy (EVT) with stent implantation vs bypass surgery (BSx) for symptomatic femoropopliteal peripheral artery disease. OBJECTIVES: This study sought to perform a pooled analysis of individual patient data from all randomized controlled trials comparing EVT vs BSx. METHODS: Principal investigators of 5 of 6 available randomized controlled trials agreed to pool individual patient data. The primary endpoint was major adverse limb events, a composite of all-cause death, major amputation, or target limb reintervention. Secondary endpoints included amputation-free survival, individual major adverse limb event components, and primary patency. Early complications were bleeding, infection, or all-cause death within 30 days. RESULTS: A total of 639 patients were analyzed with a mean age of 68.1 ± 9.1 years and 29.0% women. Baseline characteristics were comparable between groups. At 2 years, there were no significant differences between patients who received EVT and those who received BSx regarding major adverse limb events (40.1% vs 36.4%; log-rank P = 0.447; adjusted HR [aHR]: 1.04; 95% CI: 0.80-1.36), amputation-free survival (88.1% vs 90.0%; log-rank P = 0.455; aHR for death or amputation: 1.04; 95% CI: 0.63-1.71) and the other secondary endpoints except for primary patency, which was lower in patients who received EVT vs those who received BSx (51.2% vs 61.3%; log-rank P = 0.024; aHR for loss of primary patency: 1.31; 95% CI: 1.02-1.69). EVT was associated with significantly lower rates of early complications (6.8% vs 22.6%; P < 0.001) and shorter hospital stay (3.1 ± 4.2 days vs 7.4 ± 4.9 days; P < 0.001). CONCLUSIONS: These findings further support the efficacy and safety of EVT as an alternative to BSx in patients with symptomatic femoropopliteal peripheral artery disease.

Impact of complex percutaneous coronary intervention features on clinical outcomes in patients with or without chronic kidney disease.

BACKGROUND: Patients with chronic kidney disease (CKD) are at higher risk of ischemic and bleeding events after percutaneous coronary intervention (PCI). Complex PCI (CPCI) is associated with higher rates of ischemic complications. Whether CPCI confers an additive risk of adverse events in CKD patients is unclear. METHODS: Patients who underwent PCI at a single tertiary-care-center between 2012 and 2019 were stratified by CKD status and CPCI. The primary outcome was major adverse cardiac events (MACE), a composite of all-cause death, myocardial infarction (MI), and target-vessel revascularization (TVR) at 1-year follow-up. Secondary outcomes included the individual components of the primary outcome and major bleeding. RESULTS: Out of 15,071 patients, 4537 (30.1%) had CKD and 10,534 (69.9%) had no CKD. Patients undergoing CPCI were 1151 (25.4%) and 2983 (28.3%) in the two cohorts, respectively. At one year, CPCI compared with no CPCI was associated with higher risk of MACE in both CKD (Adj. HR 1.72, 95% confidence interval [CI] 1.45-2.06, p < 0.001) and no-CKD patients (Adj. hazard ratios [HR] 2.19, 95% CI 1.91-2.51, p < 0.001; p of interaction 0.057), determined by an excess of death, MI and TVR in CKD patients and of TVR and MI only in no-CKD. CPCI was related with a consistent increase of major bleeding in the CKD (Adj. HR 1.49, 95% CI 1.18-1.87, p < 0.001) and no-CKD group (Adj. HR 1.23, 95% CI 0.98-1.54, p = 0.071, p of interaction 0.206). CONCLUSION: At 1-year follow-up, CPCI was associated with higher risk of MACE and major bleeding irrespective of concomitant CKD. CPCI predicted mortality in CKD patients only.

Comparison of Drug-Coated Balloons vs Bare-Metal Stents in Patients With Femoropopliteal Arterial Disease.

BACKGROUND: Endovascular treatment of femoropopliteal artery disease has shifted toward drug-coated balloons (DCB). However, limited data are available regarding the safety and efficacy of DCB vs bare-metal stents (BMS). OBJECTIVES: The purpose of this study was to compare DCB vs BMS outcomes in a propensity-adjusted, pooled analysis of 4 prospective, multicenter trials. METHODS: Patient-level data were pooled from 4 prospective, multicenter studies: the IN.PACT SFA I/II and IN.PACT SFA Japan randomized controlled DCB trials and the Complete SE and DURABILITY II single-arm BMS studies. Outcomes were compared using inverse probability of treatment weighting (IPTW). Clinical endpoints were 12-month primary patency, freedom from 36-month clinically driven target lesion revascularization, and cumulative 36-month major adverse events (MAE). RESULTS: The primary analysis included 771 patients (288 DCB, 483 BMS). IPTW-adjusted demographic, baseline lesion, and procedural characteristics were matched between groups. The adjusted mean lesion length was 8.1 ± 4.7 cm DCB and 7.9 ± 4.5 cm BMS. The IPTW-adjusted Kaplan-Meier estimates of 12-month primary patency (90.4% DCB, 80.9% BMS, P = 0.007), freedom from 36-month clinically driven target lesion revascularization (85.6% DCB, 73.7% BMS, P = 0.001), and cumulative incidence of 36-month MAE (25.3% DCB, 38.8% BMS, P < 0.001) favored DCB. There were no statistically significant differences observed in all-cause mortality, target limb major amputation, or thrombosis through 36 months. CONCLUSIONS: In a patient-level, IPTW-adjusted pooled analysis of prospective, multicenter pivotal studies, DCB demonstrated significantly higher patency, lower revascularization and MAE rates, and no statistically significant differences in mortality, amputation, or thrombosis vs BMS. This analysis supports DCB use vs BMS in moderately complex femoropopliteal lesions amenable to both treatments.