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Flow characteristics of reperfusion sheaths when utilizing large bore mechanical circulatory support devices
No full textBACKGROUND: Reperfusion sheaths are commonly utilized to prevent acute limb ischemia (ALI) when using large bore mechanical circulatory support devices, though little is known about flow characteristics of these sheaths.
METHODS: The purpose of this assessment was to characterize the flow rates of various femoral to femoral (fem-fem) bypass circuits. We devised a test setup that maintains a preset input pressure for test devices to enable an accurate comparison of bypass techniques.
RESULTS: Negligible flow rate increases were observed in active or passive ipsilateral and contralateral circuits when donor or receiver sheaths were sequentially increased in size. When using a contralateral fem-fem bypass circuit, the use of a Merit Prelude Pro 8F sheath paired with a 5F Arrow reperfusion sheath provided 167 ml/min of flow. If the reperfusion sheath was exchanged to a 6F sheath the flow rate was 169 ml/min, 175 ml/min with a 7F sheath and 179 ml/min with an 8F sheath, a total difference of 7 %. When maintaining a 6F reperfusion sheath as a constant, the use an ipsilateral fem-fem bypass circuit using an Abiomed 14F Low profile sheath provided 215 ml/min of flow, a 27 % higher flow than a contralateral 8F circuit. The use of an active pressure bypass system using an 18F ECMO cannula provided 356 ml/min, a 66 % higher flow than a 14F ipsilateral fem-fem bypass and 110 % higher flow than an 8F contralateral fem-fem bypass.
CONCLUSION: Flow rate through a fem-fem bypass circuit is contingent upon the smallest diameter along the pathway which is typically the side port of the sheath. There are negligible changes in flow rate based on increasing donor or receiver sheath sizes. Novel, purpose-built reperfusion sheath taking these flow characteristics into account are needed to improve such systems
Vascular Access-Site Complications in Chronic Total Occlusion Percutaneous Coronary Intervention
No full textBACKGROUND: Vascular access-site complications (VASC) can occur during chronic total occlusion (CTO) percutaneous coronary intervention (PCI).
METHODS: We compared the baseline and procedural characteristics, and outcomes of patients with versus without VASC in a large multicenter CTO PCI registry. VASC was defined as any of the following: small hematoma (hematoma \u3c 5 cm), large hematoma (hematoma ≥ 5 cm), arteriovenous fistula, pseudoaneurysm and acute arterial closure.
RESULTS: VASC occurred in 158 of 16,810 CTO PCIs (0.9%). VASC patients were older (67 ± 11 vs. 64 ± 10 years, p \u3c 0.001), more likely to be women (28.4% vs. 19.1%, p = 0.004) and less likely to be current smokers (18.9% vs. 27.2%, p = 0.026). They were more likely to have at least one femoral access (89.2% vs. 75.3%, p \u3c 0.001) and less likely to have any radial access (38.0% vs. 52.3%, p \u3c 0.001). Transfemoral access was more common in patients with VASC (60.1% vs. 45.7%, p \u3c 0.001). VASC cases had higher J-CTO (2.57 vs. 2.38, p = 0.05) and PROGRESS-CTO major adverse cardiac events (MACE) scores (3.27 vs. 2.58, p \u3c 0.001). They had similar technical (87.3% vs. 87.1%, p \u3e 0.9) and procedural (82.3% vs. 85.9%, p = 0.2) success, but higher MACE (6.3% vs. 1.9%, p \u3c 0.001) and bleeding (23.4% vs. 0.4%, p \u3c 0.001). Female gender (odds ratio [OR] 1.95, 95% confidence intervals [CI] 1.24-3.00, p = 0.003), at least one femoral access (OR 2.02, 95% CI 1.09-4.04, p = 0.034) and sheath size (7-F: OR 2.16, 95% CI 1.12-4.60, p = 0.031; 8-F: OR 2.11, 95% CI 1.03-4.70,p = 0.051) were associated with VASC in multivariable analysis.
CONCLUSION: Female sex, femoral access and larger sheaths ≥ 7 F were associated with VASC in patients undergoing CTO PCI
Healthcare Utilization and Costs Among Commercially Insured Infants With and Without Medically Complex Conditions
No full textBACKGROUND: Little is known about healthcare use and costs for commercially insured infants in the first year of life following a Neonatal Intensive Care Unit (NICU) hospitalization.
PURPOSE: To evaluate healthcare utilization and costs in the 12-months after a neonatal hospitalization among commercially insured infants, comparing infants with and without medically complex conditions.
METHODS: This retrospective, cross-sectional, cohort study uses data from the IBM MarketScan Commercial database (2015-2019). The cohort included infants with and without medically complex conditions, hospitalized at birth in the NICU, discharged alive, and had 12-months continuous coverage. The primary outcomes are healthcare utilization (i.e., hospital readmissions, emergency department (ED) visits, and primary care and specialty outpatient visits) and out-of-pocket (OOP) costs.
RESULTS: The analysis included 23,940 infants, of which 84% resided in urban areas, 48% were born term (\u3e37 weeks) and 43% had a medically complex diagnosis. Medically complex infants exhibited higher rates of readmissions, ED visits, specialist utilization, and specialty services. Average OOP costs for medically complex infants was 873 for noncomplex infants. Almost half (48%) of the cohort had costs that exceeded $500 in the first year of life.
IMPLICATIONS FOR PRACTICE AND RESEARCH: This study provides insights into the financial implications of post-NICU care for infants. Findings underscore the importance of considering medical complexity over gestational age when understanding healthcare use and spending patterns. Policymakers, healthcare providers, and families can use these insights to address the financial challenges associated with caring for infants with complex medical conditions beyond the NICU
Analysis of Adverse Events of Endoscopic Ultrasound-Guided Lumen-Apposing Metal Stent Placement: Insights Across Various Indications and Techniques
No full textBACKGROUND: Endoscopic ultrasound (EUS)-guided lumen-apposing metal stent (LAMS) placement is increasingly being used in lieu of surgery for multiple procedures, including transmural fluid drainage. However, few studies have evaluated adverse events (AEs) associated with LAMS placement. Our aim was to characterize the rates of AEs associated with several LAMS placement strategies across different procedures and indications.
METHODS: A single-center retrospective cross-sectional study was conducted on patients who underwent EUS-guided LAMS placement between 2015 and 2023 at a single institution. Technical and clinical success rates and rates of early and late AEs were analyzed. Comparisons of AE rates were determined for patients who had LAMS dilation versus those without dilation, patients who had plastic stent placement in addition to LAMS placement versus those with no plastic stents, and patients who had combined dilation and plastic stent procedures versus those with LAMS dilation only.
RESULTS: A total of 243 patients underwent EUS-guided LAMS interventions: 110 (45.3%) women and 133 (54.7%) men (mean age 53.7 ± 15.9 years). There were 96 (39.5%) patients who had at least one AE. Abdominal pain was the most common early and late AE. Plastic stent placement alongside LAMS placement was associated with a significantly higher rate of overall AEs (48.3% vs 29.9%; P = 0.009), late AEs (33% vs 17.9%; P = 0.021), and stent occlusion (5.7% vs 0%; P = 0.046). LAMS dilation was associated with higher rates of late AEs (34.2% vs 20.6%; P = 0.022) and stent occlusion (6.2% vs 1.0%; P = 0.049).
CONCLUSIONS: LAMS placement showed high technical and clinical success rates across different indications with mostly mild AEs, suggesting that LAMSs may be safe and effective for pancreatic and biliary drainage
CNM-Au8 in Amyotrophic Lateral Sclerosis: The HEALEY ALS Platform Trial
No full textIMPORTANCE: Bioenergetic failure has been proposed as a driver of amyotrophic lateral sclerosis (ALS). CNM-Au8 is a suspension of gold nanocrystals that catalyzes the conversion of nicotinamide adenine dinucleotide hydride into NAD+, resulting in an increase of cellular adenosine triphosphate production.
OBJECTIVE: To determine the effects of CNM-Au8 on ALS disease progression.
DESIGN, SETTING, AND PARTICIPANTS: CNM-Au8 was tested as a regimen of the HEALEY ALS Platform Trial, a phase 2/3, multicenter, randomized, double-blind platform trial. The study was conducted at 54 sites in the US from July 2020 to March 2022 (final follow-up, March 17, 2022). A total of 161 participants with ALS were randomized to receive CNM-Au8 (n = 120) or regimen-specific placebo (n = 41). Data from 123 concurrently randomized placebo participants in other regimens were combined for analyses.
INTERVENTIONS: Eligible participants were randomized in a 3:3:2 ratio to receive CNM-Au8 60 mg daily (n = 61), CNM-Au8 30 mg daily (n = 59), or matching placebo (n = 41) for 24 weeks.
MAIN OUTCOMES AND MEASURES: The primary efficacy outcome was change from baseline through week 24 in ALS disease severity measured by a bayesian shared parameter model of function (based on the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale) and survival, which provided an estimate of the rate of disease progression measured by the disease rate ratio (DRR), with a DRR of less than 1 indicating treatment benefit. Secondary end points included a Combined Assessment of Function and Survival using a joint-rank test, rate of decline in slow vital capacity (percent predicted), and survival free of permanent assisted ventilation.
RESULTS: Among 161 participants who were randomized within the CNM-Au8 regimen (mean age, 58.4 years; 61 [37.9%] female), 145 (90%) completed the trial. In the primary analysis comparing the combined CNM-Au8 dosage groups vs the combined placebo groups, the primary end point (DRR, 0.97 [95% credible interval, 0.783-1.175]; posterior probability of DRR \u3c 1, 0.65) and the 3 secondary end points suggested no benefit or harm of CNM-Au8. In the active (n = 120) vs placebo (n = 163) groups, the most common adverse events were diarrhea (23 [19%] vs 12 [7%]), nausea (17 [14.2%] vs 14 [8.6%]), fatigue (12 [10.8%] vs 30 [18.4%]), and muscular weakness (24 [20%] vs 45 [27.6%]).
CONCLUSIONS AND RELEVANCE: No benefit of CNM-Au8 on ALS disease progression was observed at 24 weeks.
TRIAL REGISTRATION: ClinicalTrials.gov Identifiers: NCT04297683, NCT04414345
Risk factors associated with surgical site infection after internal fixation of ballistic diaphyseal fractures.
No full textOBJECTIVES: Management of civilian gunshot wound (GSW) fractures is controversial, with limited data on infection risk and controversy regarding treatment. While lower-energy GSWs are considered lower risk than other open fractures, complication rates remain high. This study aimed to identify risk factors for infection in operatively treated ballistic fractures.
METHODS: After institutional review board approval, we identified 2136 GSW-related fractures from 01/01/2012 to 12/31/2021 at our level one trauma center. After excluding articular, hand, foot, injuries through viscera and pre-existing infections, 110 patients with 125 long bone fractures were retrospectively reviewed. The primary outcome was infection requiring reoperation. Statistical analysis included Mann-Whitney U, T-tests, Pearson\u27s Chi-square, ROC analysis, and Youden\u27s index.
RESULTS: Sixteen patients (14.5 %) developed infections requiring reoperation. The cohort had a mean age of 30 years, 90 % male, BMI 27.7 ± 7.2 kg/m², Charlson comorbidity index \u3c 1, and 37 % smokers. Increased infection risk was associated with admission glucose (p \u3c 0.001) and length of stay (p \u3c 0.001). Admission glucose \u3e156 mg/dL increased odds of infection sixfold (OR 6.1, 95 % CI 2.0-19.0), while a hospital stay \u3e10 days increased odds of infection twentyfold (OR 21.1, 95 % CI 5.3-82.7). Transfusion (p = 0.004), abdominal (p = 0.007), and chest trauma (p = 0.010) also correlated with infection risk. No significant associations were found with nicotine use, Charlson comorbidity index, or BMI.
CONCLUSIONS: Operatively treated long bone injuries had a 14.5 % infection rate. Elevated admission glucose and prolonged hospital stay significantly increased infection risk, particularly in polytrauma patients. Identifying high-risk patients, promoting early mobilization, and ensuring glycemic control may help reduce infections. Further research is needed to develop targeted prevention strategies.
LEVEL OF EVIDENCE: 3 (Retrospective Comparative Study)
Impact of Bypass Conduit and Early Technical Failure on Revascularization for Chronic Limb-Threatening Ischemia
No full textBACKGROUND: The optimal strategy for lower extremity revascularization (surgical bypass versus endovascular intervention) in patients with chronic limb-threatening ischemia (CLTI) is unclear. We examined the effectiveness of open surgical bypass using single-segment great saphenous vein conduit (SSGSV), alternative conduits (AC), or endovascular interventions (ENDO) among patients with CLTI deemed acceptable for either open surgical bypass or ENDO treatment.
METHODS: This was a planned as-treated analysis of the multicenter BEST-CLI (Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia) randomized controlled trial comparing open surgical bypass and ENDO for CLTI due to infrainguinal peripheral artery disease. Outcomes were tabulated based on the initial revascularization received: SSGSV bypass, AC bypass, and ENDO. Analyses were performed for all treated patients and then excluding those who experienced early technical failure. Multivariable Cox regression models were used. End points included the primary trial outcome (major adverse limb event [MALE] or all-cause death), major amputation, MALE at any time or perioperative (30-day) death, reintervention-amputation-death, and all-cause mortality.
RESULTS: Among 1780 patients with CLTI, treatments received included SSGSV bypass (n=621), AC bypass (n=236), and ENDO (n=923) procedures. There were no significant differences in 30-day mortality, major adverse cardiovascular events, or serious adverse events; subjects treated with ENDO experienced greater MALE within 30 days (13.1% versus 2.7%, 3% for SSGSV, AC; P\u3c 0.001). On risk-adjusted analysis, SSGSV bypass was associated with reduced MALE or all-cause death (hazard ratio, 0.65 [95% CI, 0.56-0.76]; P\u3c 0.001), major amputation (hazard ratio, 0.70 [95% CI, 0.52-0.94]; P=0.017), MALE or perioperative death (hazard ratio, 0.51 [0.41-0.62]; P\u3c 0.001), and reintervention-amputation-death (hazard ratio, 0.69 [95% CI, 0.61-0.79]; P \u3c 0.001). AC bypass was associated with reduced MALE or perioperative death and reintervention-amputation-death compared with ENDO. Significant benefits of SSGSV over ENDO remained when excluding patients who experienced early technical failure. There were no significant differences in long-term mortality by initial treatment received. When analyzed by the level of disease treated, the improved outcomes of SSGSV were greatest among patients who underwent femoropopliteal revascularization.
CONCLUSIONS: Analysis of as-treated outcomes from the BEST-CLI trial demonstrates the safety and clinical superiority of bypass with SSGSV among patients with CLTI who were deemed suitable for either open surgical bypass or ENDO revascularization. Assessment of great saphenous vein quality should be incorporated into the evaluation of patients with CLTI who are surgical candidates.
REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT02060630 and NCT02060630
Socioeconomic Disparities in Prostate Cancer Treatment: The Impact of Area Deprivation Index on Initial Treatment Type for Localized PCa in a North-American Cohort
No full textBACKGROUND: Socioeconomic status and geographical location contribute to disparities in localized prostate cancer (PCa) treatment. We examined the impact of area of deprivation index (ADI) on initial treatment type for localized PCa in a North-American cohort.
METHODS: We performed a retrospective analysis of patients diagnosed with localized PCa, treated within Henry Ford Health (HFH), between 1995 and 2022, with available ADI-data. ADI was assigned based on residential census block group, ranked as a national deprivation percentile. Patients were categorized into three treatment-groups: radical prostatectomy (RP), radiation therapy (RT) and other treatment. Using multinomial logistic regression, we assessed ADI impact on treatment choice. After excluding patients without cT, ISUP-grade and/or PSA, we stratified by D\u27Amico risk-classification and repeated the regression analysis in each subgroup.
RESULTS: Among 14,204 patients, 28.4% were NHB. Median (IQR) age at diagnosis was 65 (59-71) years. Median (IQR) ADI was 58 (36-83) for overall cohort and 51 (30-74), 66 (45-91), and 62 (39-88) for RP, RT, and other groups, respectively (p \u3c 0.0001). Multivariable analysis showed ADI as an independent predictor of treatment choice (p = 0.01): for each 10-unit increase in ADI, patients were 3% more likely to receive RT and 10% less likely to receive RP. High ADI predicted a lower likelihood of receiving initial surgery across all risk-groups (p \u3c 0.001).
CONCLUSIONS: Patients in more advantaged areas were more likely to receive RP, while those in disadvantaged areas received more RT. Recognizing how neighborhood factors affect treatment choices is crucial for improving health equity and reducing disparities in PCa outcomes
