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Preoperative smoking cessation improves carotid endarterectomy outcomes in asymptomatic carotid stenosis patients
OBJECTIVE: Smoking cessation has been suggested as having the potential to improve the outcomes of carotid endarterectomy (CEA) and mitigate the risk of long-term stroke in patients with asymptomatic carotid stenosis (ACS). This study aims to compare the perioperative and long-term outcomes of CEA in patients with ACS across different smoking status groups.
METHODS: All patients receiving an elective CEA for ACS between 2013 and 2023 were identified in the Vascular Quality Initiative (VQI). Patients with an ipsilateral carotid stenosis \u3c70% and those receiving a concomitant coronary artery bypass graft were excluded. Patients were then classified according to their smoking status: never smokers, former smokers (defined as those who have stopped smoking more than 30 days prior to their operation), and current smokers. Patient characteristics and outcomes were compared using the χ(2) or Fischer exact test as appropriate for categorical variables and the analysis of variance or Kruskal-Wallis test as appropriate for continuous variables. Cox regression analysis was used to study the association between smoking status and the primary outcomes of long-term stroke and major adverse cardiac events (MACE) defined as the composite outcome of stroke, myocardial infarction, and/or mortality.
RESULTS: A total of 77,664 patients received a CEA for ACS, of which 19,416 patients (25%) were never smokers, 39,374 patients (51%) were former smokers, and 18,874 patients (24%) were current smokers. Patients in the three groups had similar rates of perioperative stroke (P = .79), myocardial infarction (P = .07), mortality (P = .23), and MACE (P = .17). At 18-month follow-up, former and never smokers had similar rates of stroke (former 0.9% vs never 0.8%; P = .92), with former smokers exhibiting a lower stroke risk than current smokers (former 0.9% vs current 1.5%; P = .001). At 18 months, former smokers had a significantly lower rate of MACE compared with current smokers (former 11.8% vs current 13.2%; P = .03), but a higher rate compared with never smokers (former 11.8% vs never 8.7%; P \u3c .001). On multivariate Cox regression analysis, compared with current smokers, former smokers were independently associated with a lower risk of stroke (hazard ratio [HR], 0.68; 95% confidence interval [CI], 0.53-0.87; P = .002), mortality (HR, 0.79; 95% CI, 0.74-0.84; P \u3c .001), and MACE (HR, 0.77; 95% CI, 0.70-0.83; P \u3c .001). No difference in long-term stroke risk was observed between former and never smokers (HR, 1.06; 95% CI, 0.82-1.38; P = .65).
CONCLUSIONS: This study demonstrates that preoperative smoking cessation in patients with ACS significantly reduces the risk of stroke, mortality, and MACE following CEA compared with continued smoking, aligning their outcomes more closely with those of never smokers. Optimizing patients with ACS prior to surgery should include smoking cessation counseling. Vascular surgeons play a critical role in encouraging smoking cessation, as their guidance can significantly improve patient outcomes following CEA
Outcomes of Deceased Donor Kidneys Turned Down for Biopsy Results That Were Transplanted Elsewhere
Background: The number of kidney transplants performed in the US remains insufficient for the number of patients awaiting one. To meet these demands, transplant centers should review their kidney utilization, especially for kidneys that were not accepted. Previous review of kidney offers turned down at our institution revealed a common refusal reason to be unacceptable biopsy results. Some of these organs were subsequently transplanted elsewhere. We analyzed accepted versus turned down biopsied kidneys for Henry Ford Hospital (HFH) to assess our acceptance practices and the need for modifying our acceptance criteria. Methods: Retrospective analysis of OPTN data on deceased donor kidneys offered by Gift of Life Michigan to HFH between 8/2/2022 and 7/19/2024. Only kidneys that were biopsied and ultimately transplanted were included. Biopsied kidneys were classified as either “kidney transplanted by center (KTC)” if accepted and transplanted by HFH and “kidney transplanted elsewhere (KTE)” if turned down by HFH and transplanted elsewhere. Only kidneys turned down for biopsy- specific reasons were included in the analysis. Kidney characteristics and recipient outcomes were compared between the groups. Outcomes of interest were rate of delayed graft function (DGF), recipient 6-month and 1-year serum creatinine (Se Cr), and 6-month and 1-year graft (GS) and patient survival (PS). Results: 103 offers with kidney biopsies were included in the analysis, with 46 in the KTC group and 57 in the KTE group. Selected analysis results are shown in Figure 1. KTE kidneys had a significantly higher percentage of glomerulosclerosis and longer cold ischemia time. Donor characteristics and other biopsy features did not differ significantly between the groups. Recipient outcomes did not differ significantly between the two groups in terms of DGF rate, 6-month and 1-year Se Cr, and 6-month and 1-year GS or PS. Conclusions: While kidney characteristics differed between accepted and passed biopsy kidneys, no significant differences in renal allograft outcomes were noted. Findings of comparable outcomes with KTE kidneys can help reframe a center’s understanding of acceptable organ quality metrics and motivate centers to rethink and expand their acceptance criteria. [Formula presented] DISCLOSURES: Z.Y. Lu: None. A. Yoshida: None. A. Patel: None
Impact of Machine Perfusion on Liver Transplantation for Hepatocellular Carcinoma
Extended criteria donor grafts are more susceptible to ischemic-reperfusion injury and are associated with worse post-transplant outcomes. Existing studies on use of machine perfusion (MP) in patients with hepatocellular carcinoma (HCC) undergoing transplantation is limited, though some data suggests ischemic damage in the transplant liver might increase the risk for cancer recurrence. Use of MP for patients with HCC potentially improves overall and oncological outcomes in this population. In this study, we analyzed a large national database to evaluate the role of MP on post-transplant outcomes in patients with HCC. Adults transplanted with a diagnosis of HCC between 2015 and 2022 from the United Network for Organ Sharing (UNOS) database were divided into two populations, based on use of MP for the procured liver. Post-transplant outcomes assessed included: overall survival (OS) and HCC recurrence (competing-risk) using Cox regression and Fine-Gray models, respectively. HCC recurrence was defined from the UNOS database by merging the two reported follow up outcomes: cause of death related to HCC or post-transplant recurrence of malignancy. Of the 15,374 patients with HCC who underwent liver transplant and had MP data, 284 (1.8%) used MP for the donor liver. The 3-year OS was significantly higher with MP use (93.0% in MP group versus 86.2% no MP; p=0.03) (Figure 1). Cox hazard regression model for 3-year OS showed that use of MP reduced risk of death, independent of HCC recurrence (hazard ratio 0.62 95% confidence interval 0.40-0.97; p=0.035). The use of MP was not related to 3-year HCC recurrence on competing risk analysis (recurrence and death) (3-year recurrence rate: 2.1% in MP group versus 4.2% no MP, p=0.50). Overall, only a small proportion of patients with HCC had liver transplant with use of MP in the donor liver. However, this group demonstrated significantly better 3-year OS, without significant difference in HCC recurrence. HCC recurrence might be underreported or uncaptured in the UNOS data, therefore, as the utilization of MP grows, further investigations into possible associations between HCC recurrence and improved survival outcomes in the MP group would be warranted. [Formula presented] DISCLOSURES: L. Rajendran: None. R. Oki: None. E. Kerby: None. A. Nassar: None. A. Mohamed: None. A. Al-Kurd: None. A. Yoshida: None. M. Abouljoud: None. S. Nagai: None
Design and Rationale of a Pragmatic Randomized Clinical Trial of Early Dronedarone Versus Usual Care to Change and Improve Outcomes in Persons with First-Detected Atrial Fibrillation - the CHANGE AFIB Study
BACKGROUND: While there are several completed clinical trials that address treatment strategies in patients with symptomatic and recurrent atrial fibrillation (AF), there are no randomized clinical trials that address first-line rhythm control of new-onset AF. Recent data suggest that early initiation of rhythm control within 1 year can improve outcomes.
METHODS: In this open-label pragmatic clinical trial nested within the Get with The Guidelines Atrial Fibrillation registry, approximately 3,000 patients with first-detected AF will be enrolled at approximately 200 sites. Participants will be randomized (1:1) to treatment with dronedarone in addition to usual care versus usual care alone. The primary endpoint will be time to first cardiovascular (CV) hospitalization or death from any cause through 12 months from randomization. Secondary endpoints will include a WIN ratio (all-cause death, ischemic stroke or systemic embolism, heart failure hospitalization, acute coronary hospitalization), CV hospitalization, and all-cause mortality. Patient reported outcomes will be analyzed based on change in Atrial Fibrillation Effect on Quality of Life (AFEQT) and change in Mayo AF-Specific Symptom Inventory (MAFSI) from baseline to 12 months.
CONCLUSION: CHANGE AFIB will determine if treatment with dronedarone in addition to usual care is superior to usual care alone for the prevention of CV hospitalization or death from any cause in patients with first-detected AF. The trial will also determine whether initiation of rhythm control at the time of first-detected AF affects CV events or improves patient reported outcomes.
TRIAL REGISTRATION: - NCT05130268
Ceftriaxone Versus Cefepime or Carbapenems for Definitive Treatment of Low-Risk AmpC-Harboring Enterobacterales Bloodstream Infections in Hospitalized Adults: A Retrospective Cohort Study
OBJECTIVE: To compare outcomes of ceftriaxone to AmpC-stable therapies in patients with bacteremia caused by low-risk AmpC harboring Enterobacterales.
METHODS: IRB-approved, retrospective cohort of hospitalized patients ≥18 years old with Serratia marcescens, Morganella morganii, or Providencia spp. bacteremia from 1/1/2017-2/28/2024. Patients were compared by definitive therapy with ceftriaxone vs AmpC-stable therapy (cefepime, carbapenem). The primary endpoint was 30-day all-cause mortality; secondary endpoints were clinical failure and development of ceftriaxone resistance.
RESULTS: 163 patients were included; 33.1 % received ceftriaxone, 66.9 % AmpC-stable therapies. 30-day all-cause mortality was 9.3 % ceftriaxone vs 10.1 % AmpC stable patients (P = 0.87); ceftriaxone definitive therapy was not associated with 30-day all-cause mortality (adjOR, 0.79; 95 %CI, 0.23-2.3). There were no differences in clinical failure (9.3 % vs 21.1 %, P = 0.059) or relapsing infection (5.6 % vs 9.3 %, P = 0.55) between ceftriaxone and AmpC-stable treated patients.
CONCLUSIONS: Patients treated with definitive ceftriaxone for low-risk AmpC Enterobacterales bacteremia had similar outcomes to AmpC stable therapies
Association of Race with Incidence, Characteristics, and Mortality from Incidental Prostate Cancer: Analysis of Two North American Contemporary Cohorts
BACKGROUND: Non-Hispanic Black (NHB) men are at higher risk both for incidence and mortality from prostate cancer (PCa) compared to Non-Hispanic White (NHW) men, but these findings arise from biopsy-detected PCa reports. We aimed to compare the incidence, subsequent management and cancer-specific mortality (CSM) of incidental PCa among NHB and NHW men, using two different North American cohorts.
METHODS: The Surveillance, Epidemiology and End-Result (SEER: 2004-2017) and our institutional Henry Ford Health (HFH: 1995-2022) databases were queried to identify men diagnosed with incidental PCa. Cumulative incidence estimates were used to calculate CSM differences between NHB and NHW men. Competing-risk multivariable regression analysis tested the impact of race on CSM, after accounting for all available covariates.
RESULTS: A total of 418 and 6,124 incidental PCa cases were recorded in HFH and SEER database respectively. No pathological differences were observed between NHB and NHW men in both the cohorts, except for prostate-specific antigen (PSA) value at diagnosis, which was higher in NHB men. At 10-years, the CSM rates were 5.5% vs 7.2% in our cohort and 8.6% vs 10.3% in the SEER cohort for NHW and NHB men, respectively (all Gray\u27s test p-value \u3e 0.05). At multivariable, race was not an independent predictor of CSM in our HFH cohort (HR: 1.46, 95% CI: 0.57-3.71, p = 0.6). In the SEER cohort, NHB men were 34% less likely to die from PCa from 1 year to the next (95% CI: 0.49-0.90, p = 0.008), when compared with NHW men.
CONCLUSIONS: In the comparison of incidental PCa findings between NHB and NHW men, both groups had similar pathological characteristic and survival outcomes. These findings are different from the \u27conventional\u27 screening-detected PCa and suggest that racial differences have minimal to no adverse effects on PCa-specific mortality after incidental diagnosis
Association of Proximal Vessel Tortuosity with Technical Success and Clinical Outcomes: Analysis From the Progress-CTO Registry
BACKGROUND: Proximal vessel tortuosity can hinder wiring and equipment delivery during chronic total occlusion (CTO) percutaneous coronary intervention (PCI).
AIMS: We sought to examine the association of proximal vessel tortuosity with the short and long-term outcomes of patients undergoing CTO PCI.
METHODS: We examined the association of proximal vessel tortuosity with clinical outcomes in patients who underwent CTO PCI at 50 US and non-US centers between 2012 and 2024.
RESULTS: Of 14,141 patients, 3,974 (28.1%) had moderate or severe proximal vessel tortuosity. Patients with moderate or severe proximal vessel tortuosity had more comorbidities and more complex angiographic characteristics, such as longer lesion length and higher prevalence of side branch at the proximal cap. Lesions with moderate or severe proximal tortuosity required greater procedure and fluoroscopy time. On unadjusted analyses, moderate/severe proximal vessel tortuosity was associated with lower technical success and higher incidence of major adverse cardiac events (MACE). In multivariable analysis, moderate/severe proximal vessel tortuosity was associated with lower technical success (odds ratio [OR]: 0.77; 95% confidence intervals [CI]: 0.67, 0.89) but similar MACE (OR: 1.26; 95% CI: 0.91, 1.73). Higher operator volume (≥ 30 CTO PCI cases per year) was associated with higher technical (85.2% vs. 75.6%, p \u3c 0.001) and procedural success (83.6% vs. 74.5%, p \u3c 0.001) but also higher risk of perforation (6.49% vs. 3.57%, p \u3c 0.001) but not pericardiocentesis, in lesions with moderate/severe proximal vessel tortuosity.
CONCLUSIONS: Moderate or severe proximal vessel tortuosity is independently associated with lower technical success in CTO PCI but not with MACE. High-volume operators are more likely to successfully perform CTO PCI in lesions with moderate/severe tortuosity at the cost of higher risk of perforation, without higher MACE
Transforming Transplantation Access: A Federal Directive for Comprehensive Pre-Waitlisting Data Collection
There is substantial variation in access to transplantation across the United States that is not entirely explained by the availability of donor organs. Barriers to transplantation and variation in care among patients with end-stage organ disease exist prior to patients\u27 placement on a transplant waiting list as well as following waitlist placement. However, there are currently no national data available to examine rates and variations in key care processes related to pre-listing, including transplant referral, evaluation, or candidate selection. In February of 2024, the Health Resources and Services Administration (HRSA) released a directive and, in November 2024, released for public comment the proposed expansion of the Organ Procurement and Transplantation Network (OPTN) data collection to include pre-waitlist data for all solid organ transplant patients to promote transparency across the transplant continuum. While data elements and details have not been finalized, the purpose of this article is to detail the rationale and anticipated details for pre-waitlisting data collection to inform the transplant community. These data aim to examine care processes and barriers to care for patients with end-stage organ disease in the United States
Outpatient chemotherapy drug costs and expensive chemotherapy drug use in 340B and Non-340B hospitals: an observational study
BACKGROUND: The 340B Drug Pricing Program has been controversial since its inception in 1992, a major criticism being that 340B hospitals use more outpatient drugs, and more expensive drugs, because of financial incentives to make money through the program. The goal of this study was to determine whether characteristics of patients treated at 340B hospitals, and affiliation of hospitals with NCI-designated cancer centers, would explain higher Part B drug costs and use of more expensive chemotherapy drugs.
METHODS: This is an observational study using data from SEER-Medicare and 340B entity database. Fee-for-service Medicare beneficiaries who were first diagnosed with cancer between 1/1/2013 and 12/31/2015 were included. Hospital, patient, and cancer/clinical characteristics were used as predictors of both overall Part B drug costs and use of expensive chemotherapy drugs. Patient characteristics and cancer conditions were compared between those who were treated at 340B and non-340B hospitals, and between those who used and who did not use any expensive chemotherapy treatment. Independent relationships between overall Part B drug costs and patients\u27 340B status, and between patients\u27 use of expensive chemotherapy drug and patients\u27 340B status were evaluated in multivariate analyses, using a stepwise generalized estimating equation modeling approach.
RESULTS: We found that patients at 340B hospitals had a somewhat higher chance of using one of the ten expensive chemotherapy drugs, and somewhat higher overall drug costs, but these relationships became non-significant when patient, cancer/clinical factors, and cancer center status were considered. Compared to the reference patients, patients who were treated in an NCI-designated cancer center or a hospital affiliated with such center, who had certain types of cancers (e.g., B-cell), or had advanced-stage disease had a higher chance to use expensive chemotherapy treatment; patients who were older, survived the first 12 months upon diagnosis, had advanced-stage disease, or had more drug claims had higher drug costs.
CONCLUSIONS: Hospital 340B status was not significantly associated with use of more expensive cancer drugs or drug costs once other relevant factors (e.g., cancer center status, advanced-stage disease) were taken into account
Concurrent management of vitiligo and acquired disorders of hyperpigmentation: a comprehensive literature review and current practice gaps
Few studies discuss the co-management of vitiligo and acquired hyperpigmentation disorders (AHD) such as melasma, erythema dyschromicum perstans, post-inflammatory hyperpigmentation, drug-induced hyperpigmentation, and lichen planus pigmentosus. This review discusses clinical studies examining co-management strategies and identifies current practice gaps. Dermatology Life Quality Index scores are higher in individuals with vitiligo or melasma. It is plausible that populations experiencing both conditions may exhibit worsened psychological outcomes because of stigmas and perceived social beauty standards. Standard treatments for vitiligo aim to increase pigmentation, while AHD treatments target decreasing pigmentation, causing potential worsening of contrast between multiple skin tones for patients experiencing both disorders. Tretinoin may prevent narrowband ultraviolet B (NBUVB)-induced hyperpigmentation in patients with vitiligo without altering treatment response and is also beneficial for managing AHD. In addition, the use of oral tranexamic acid to treat melasma does not diminish the response to NBUVB phototherapy. Platelet-rich plasma (PRP) injections and oral Polypodium leucotomos extract may also be beneficial for comanaging vitiligo and AHD. However, practice guidelines are needed to optimize care for this patient population