Unadjusted Survival Analysis Research Articles

Baseline shock index-creatinine clearance score and long-term mortality after ACS. Results from 24 years of follow-up of the ABC study on heart disease

Abstract Background Shock Index-Creatinine Clearance score (SI-C) is an updated version of the shock index that includes renal function. Recent studies reported its potential as a novel and simple risk stratification tool for predicting in-hospital mortality in acute coronary syndrome (ACS) patients. Purpose To assess the long-term predictive value of baseline SI-C score in patients after ACS. Methods This preliminary prospective analysis included 589 patients with ACS admitted to three Italian hospitals and discharged alive. Baseline clinical and laboratory data were collected within the first 7 hospitalization days and baseline SI-C score was calculated as [(SI×100)-estimated creatinine clearance]. Patients were prospectively followed for 24 years or until death. Results Virtually all patients completed the follow-up, representing 7066 person-years. Patients' mean age was 66±12 years, 70% were males, and 482(82%) had died during follow-up. Compared to those who survived, deceased patients were significantly different in many of the baseline clinical characteristics. They also showed a significantly higher SI-C values ( -11± 25 vs. -36±23, p<0.0001). The predictive value of SI-C for 24-year mortality was very good (area under the curve= 0.783, 95% CI: 0.738-0.827, p<0.001). The cumulative risk was significantly higher in the upper SI-C tertile (log-rank = 162.1, p < 0.001). Unadjusted Cox regression survival analysis showed that the SI-C score was significantly associated with long-term all-cause mortality (HR: 2.1, 95%CI 1.8-2.3, p<0.0001). Similar results were obtained with the fully adjusted model. Conclusion Baseline SI-C seems to be an effective and independent predictor of long-term all-cause mortality after ACS.

Early U.S. Heart Transplant ExperienceWith Normothermic RegionalPerfusion Following Donation After Circulatory Death.

Heart transplantation following donation after circulatory death (DCD HT) has short-term survival outcomes comparable to donation after brain death and has led to a significant increase in transplantation volume. The U.S. experience with the normothermic regional perfusion (NRP) DCD HT procurement method has not been evaluated. The aim of this study was to examine short-term outcomes associated with NRP vs direct procurement and perfusion (DPP) methods used during DCD HT in the United States. The UNOS (United Network for Organ Sharing) registry was queried for all adult (age≥18 years) heart recipients and corresponding donors of controlled DCD HT from January 2019-December 2023. Transplantations were stratified by NRP or DPP reperfusion methods. The primary outcome was overall survival. A total of 918 heart donors and recipients met inclusion criteria, including 622 (68%) DPP and 296 (32%) NRP transplantations. Unadjusted Kaplan-Meier survival analysis demonstrated improved short-term survival associated with NRP (log-rank P = 0.005). After adjustment, DCD HT with NRP was independently associated with improved survival (HR: 0.39 [95%CI: 0.22-0.70]; P = 0.002). A propensity-matched analysis similarly demonstrated a cumulative survival benefit to NRP (log-rank P = 0.006). In this largest national series of DCD HT procurement perfusion strategies, NRP is associated with improved short-term survival as compared with DPP. This study evaluates the U.S. early experience with DCD HT, and longer-term follow-up data are needed to further assess the impact of DPP and NRP methods on post-heart transplantation outcomes.

Midterm Outcomes and Predictors of Failure of Lower Extremity Bypass to Para-Malleolar and Pedal Targets

ObjectivesThe frequency of distal lower extremity bypass (LEB) for infra-popliteal critical limb threatening ischemia (IP-CLTI) has significantly decreased. Our goal was to analyze the contemporary outcomes and factors associated with failure of LEB to para-malleolar and pedal targets. MethodsWe queried the VQI infra-inguinal database from 2003-2021 to identify LEB to para-malleolar or pedal/plantar targets. Primary outcomes were graft patency, major adverse limb events [vascular re-intervention, above ankle amputation] (MALE), and amputation-free survival at 2 years. Standard statistical methods were utilized. ResultsWe identified 2331 LEB procedures (1265 anterior tibial at ankle/dorsalis pedis, 783 posterior tibial at ankle, 283 tarsal/plantar). The prevalence of LEB bypasses to distal targets has significantly decreased from 13.37% of all LEB procedures in 2003 to 3.51% in 2021 (p<0.001). The majority of cases presented with tissue loss (81.25. Common post-operative complications included major adverse cardiac events (8.9%) and surgical site infections (3.6%). Major amputations occurred in 16.8% of patients at 1 year. Post-operative mortality at 1 year was 10%.On unadjusted Kaplan-Meier survival analysis at 2 years, primary patency was 50.56%±3.6%, MALE was 63.49%±3.27%, and amputation-free survival was 71.71%±0.98%. In adjusted analyses [adjusted for comorbidities, indication, conduit type, urgency, prior vascular interventions, graft inflow vessel (femoral/popliteal), concomitant inflow procedures, surgeon and center volume] conduits other than GSV (p<0.001) were associated with loss of primary patency and increased MALE. High center volume (>5 procedures/year) was associated with improved primary patency (p=0.015), and lower MALE (p=0.021) at 2 years. ConclusionsDespite decreased utilization, open surgical bypass to distal targets at the ankle remains a viable option for treatment of IP-CLTI with acceptable patency and amputation-free survival rates at 2 years. Bypasses to distal targets should be performed at high volume centers to optimize graft patency and limb salvage and minimize re-interventions.

Impact of aging on acute myeloid leukemia epidemiology and survival outcomes: A real-world, population-based longitudinal cohort study.

Acute myeloid leukemia (AML) is a severe and fatal form of leukemia that is prevalent in the older population. In this longitudinal retrospective study, we investigated the epidemiology and survival rates of patients diagnosed with de novo acute myeloid leukemia in South Korea from Jan 1, 2011, to Aug 31, 2020. We used real-world data from the Health Insurance Review and Assessment Service database. We observed an increase in the number of acute myeloid leukemia cases, with age-specific incidence rates escalating in older patients. In contrast a long-term decrease from 1.94 to 1.77 per 100,000 individuals was found in the age-standardized incidence rates. Meanwhile, age-standardized prevalence rates ascended from 8.93 to 9.67 per 100,000 individuals, with a remarkable increase in the age-specific prevalence rate for those aged 80 years and above. Survival rates were notably better in younger or treated patients, and in those who underwent Hematopoietic stem cell transplantation. The time of diagnosis did not affect the survival of patients younger than 65 years. However, the most recent survival rates were significantly lower for patients 65 or older, as shown in the unadjusted Cox survival analysis. After adjustments in the analysis, it was found that the overall survival rates of the most recently diagnosed group improved significantly compared with those diagnosed earlier, with a hazard ratio of 0.90 (95% confidence interval, 0.84-0.97). This improvement may potentially be influenced by the enhanced treatment alternatives available for newly diagnosed older patients aged 65 years or older. In conclusion, aging appears to fuel an increase in the number of acute myeloid leukemia cases and mortality. Further studies are warranted to understand the impact of aging on acute myeloid leukemia treatment outcomes and devise efficacious care strategies for older patients.

BASELINE SHOCK INDEX–CREATININE CLEARANCE AS A PREDICTOR OF LONG–TERM MORTALITY AFTER ACS. RESULTS FROM 24 YEARS OF FOLLOW–UP OF THE ABC STUDY ON HEART DISEASE

Abstract Background Shock index (SI), defined as heart rate divided by systolic blood pressure, is a useful simple predictor of long–term mortality after acute myocardial infarction. Purpose To assess the utilization of the SI updated version that includes renal function (Shock Index–Creatinine Clearance (SI–C)) to predict long–term mortality after ACS. Methods This preliminary analysis included 589 patients with ACS admitted to three Italian hospitals and discharged alive. Baseline clinical and laboratory data were collected within the first 7 days of hospitalization and SI–C was calculated as (SI×100)–estimated CCr. Patients were prospectively followed for 24 years or until death. Results Virtually all patients completed the follow–up, representing 7066 person–years. Patients‘ mean age was 66±12 years, 70% were males and 482(82%) had died during follow–up. Compared to those who survived, deceased patients were significantly different in many clinical features. They also showed significantly higher SI–C values ( –11± 25 vs. –36±23, p&amp;lt;0.0001). The predictive value of SI–C for 24–year mortality was very good (area under the curve= 0.783, 95% CI: 0.738–0.827, p&amp;lt;0.001). The cumulative risk was significantly higher in the upper SI–C tertile (log–rank = 162.1, p &amp;lt; 0.001). Unadjusted Cox regression survival analysis showed that the SI–C score was significantly associated with long–term global mortality (HR: 2.1, 95%CI 1.8–2.3, p&amp;lt;0.0001). A fully adjusted model revealed the same results. Conclusion Baseline SI–C seems to be an effective independent predictor of long–term global mortality after ACS. It may have potential as a novel and simple early risk stratification tool for ACS patients including long–term outcomes.

Evaluation of association between center colorectal neuroendocrine neoplasm volume and survival among patients with colorectal neuroendocrine carcinoma.

Although correlation between center volume and survival has been reported for several complex cancers, it remains unknown if this is true for colorectal neuroendocrine carcinomas (CRNECs). We hypothesized that higher center annual volume of colorectal neuroendocrine neoplasm resections would be associated with overall survival (OS) for patients with CRNECs. Patients in the National Cancer Database diagnosed with stages I-III CRNEC between 2006 and 2018 and who underwent surgical resection were identified. The mean annual colorectal neuroendocrine neoplasm resection volume threshold associated with significantly worse mortality hazard was determined using restricted cubic splines. Kaplan-Meier (KM) method was used to compare OS, while Cox proportional hazards model was used for multivariable analysis. There were 694 patients with CRNEC who met inclusion criteria across 1229 centers. Based on the cubic spline, centers treating fewer than one colorectal neuroendocrine neoplasm patient every 3 years on average had worse outcomes. Centers below this threshold were classified as low-volume (LV) centers corresponding with 42% of centers and about 15% of the patient cohort. In unadjusted survival analysis, LV patients had a median OS of 14 months (95% confidence interval [CI]: 10-19) while those treated at HV centers had a median OS of 33 months (95% CI: 25-49). In multivariable analysis, resection at a LV center was associated with increased risk of mortality (1.42 [95% CI: 1.01-2.00], p = 0.04). CRNEC patients have a dire prognosis; however, treatment at an HV center may be associated with decreased risk of mortality.

Impact of Asian and Black Donor and Recipient Ethnicity on the Outcomes After Deceased Donor Kidney Transplantation in the United Kingdom.

Patients of Asian and black ethnicity face disadvantage on the renal transplant waiting list in the UK, because of lack of human leucocyte antigen and blood group matched donors from an overwhelmingly white deceased donor pool. This study evaluates outcomes of renal allografts from Asian and black donors. The UK Transplant Registry was analysed for adult deceased donor kidney only transplants performed between 2001 and 2015. Asian and black ethnicity patients constituted 12.4% and 6.7% of all deceased donor recipients but only 1.6% and 1.2% of all deceased donors, respectively. Unadjusted survival analysis demonstrated significantly inferior long-term allograft outcomes associated with Asian and black donors, compared to white donors. On Cox-regression analysis, Asian donor and black recipient ethnicities were associated with poorer outcomes than white counterparts, and on ethnicity matching, compared with the white donor-white recipient baseline group and adjusting for other donor and recipient factors, 5-year graft outcomes were significantly poorer for black donor-black recipient, Asian donor-white recipient, and white donor-black recipient combinations in decreasing order of worse unadjusted 5-year graft survival. Increased deceased donation among ethnic minorities could benefit the recipient pool by increasing available organs. However, it may require a refined approach to enhance outcomes.

The survival after thyroidectomy versus lobectomy in multifocal papillary thyroid microcarcinoma patients.

The extent of thyroid surgery for multifocal papillary thyroid microcarcinoma (PTMC) remains controversial. Studies on the optimal surgical approach for a multifocal PTMC are scarce. This study aimed to compare the effectiveness of thyroidectomy and lobectomy for the treatment of multifocal PTMC. A population-based retrospective cohort of patients with multifocal PTMC was analyzed using the Surveillance, Epidemiology, and End Results (SEER) database between 2004 and 2017, and divided into two groups (thyroidectomy, lobectomy) based on the surgical approach. The clinicopathologic features and survival outcomes were compared between the two groups. Cox proportional hazards regression analysis to explore prognostic factors of survival. Propensity score matching (PSM) was used to balance covariates. Overall, a total of 9387 multifocal PTMC patients were included in the study. Among them, 8,107 (86.36%) patients received thyroidectomy, and 1280 (13.64%) patients underwent lobectomy. Compared to patients in the thyroidectomy group, patients in the lobectomy group were diagnosed with older age (50.47 years vs. 49.32 years, p = 0.003), a higher proportion of males (20.47% vs. 14.99%, p < 0.001), larger tumors (6.22 mm vs. 4.97 mm, p < 0.001), and more frequently underwent radiotherapy (35.40% vs. 10.16%, p < 0.001). Multivariate Cox regression analysis revealed that age was the only independent prognostic factor for thyroid cancer-specific survival (TCSS), and the determinants of overall survival (OS) were age and gender. Unadjusted survival analysis revealed no difference between the two treatment groups in TCSS (p = 0.598) and OS (p = 0.126). After 1:1 Propensity Score Matching (PSM), there was still no difference in TCSS (p = 0.368) or OS (p = 0.388). The stratified analysis revealed that for patients aged under or above 55, thyroidectomy was not associated with superior BCSS or OS (p > 0.05). Thyroidectomy was not associated with improved survival compared to thyroid lobectomy for patients with multifocal PTMC.

Long-Term Survival Following Primary Graft Dysfunction Development in Lung Transplantation

IntroductionPrimary graft dysfunction (PGD) is a known risk factor for early mortality following lung transplant (LT). However, the outcomes of patients who achieve long-term survival following index hospitalization are unknown. We aimed to determine the long-term association of PGD grade 3 (PGD3) in patients without in-hospital mortality. MethodsLT recipients were identified from the United Network for Organ Sharing Database. Patients were stratified based on the grade of PGD at 72 h (No PGD, Grade 1/2 or Grade 3). Groups were assessed with comparative statistics. Long-term survival was evaluated using Kaplan–Meier methods and a multivariable shared frailty model including recipient, donor, and transplant characteristics. ResultsThe PGD3 group had significantly increased length of stay, dialysis, and treated rejection post-transplant (P < 0.001). Unadjusted survival analysis revealed a significant difference in long-term survival (P < 0.001) between groups; however, following adjustment, PGD3 was not independently associated with long-term survival (hazard ratio: 0.972; 95% confidence interval: 0.862-1.096). Increased mortality was significantly associated with increased recipient age and treated rejection. Decreased mortality was significantly associated with no donor diabetes, bilateral LT as compared to single LT, transplant in 2015-2016 and 2017-2018, and no post-transplant dialysis. ConclusionsWhile PGD3 remains a challenge post LT, PGD3 at 72 h is not independently associated with decreased long-term survival, while complications such as dialysis and rejection are, in patients who survive index hospitalization. Transplant providers should be aggressive in preventing further complications in recipients with severe PGD to minimize the negative association on long-term survival.

Foot and Ankle Care by Podiatrists and Amputations in Patients With Diabetes and Kidney Failure

Patients with kidney failure have an increased risk of diabetes-related foot complications. The benefit of regular foot and ankle care in this at-risk population is unknown. To investigate foot and ankle care by podiatrists and the outcomes of diabetic foot ulcers (DFUs) in patients with kidney failure. This retrospective cohort study included Medicare beneficiaries with type 2 diabetes receiving dialysis who had a new DFU diagnosis. The analysis of the calendar year 2016 to 2019 data from the United States Renal Data System was performed on June 15, 2023, with subsequent updates on December 11, 2023. Foot and ankle care by podiatrists during 3 months prior to DFU diagnosis. The outcomes were a composite of death and/or major amputation, as well as major amputation alone. Kaplan-Meier analysis was used to estimate 2 to 3 years of amputation-free survival. Foot and ankle care by podiatrists and the composite outcome was examined using inverse probability-weighted Cox regression, while competing risk regression models were used for the analysis of amputation alone. Among the 14 935 adult patients with kidney failure and a new DFU (mean [SD] age, 59.3 [12.7] years; 35.4% aged ≥65 years; 8284 men [55.4%]; Asian, 2.7%; Black/African American, 35.0%; Hispanic, 17.7%; White, 58.5%), 18.4% (n = 2736) received care by podiatrists in the 3 months before index DFU diagnosis. These patients were older, more likely to be male, and have more comorbidities than those without prior podiatrist visits. Over a mean (SD) 13.5 (12.0)-month follow-up, 70% of those with podiatric care experienced death and/or major amputation, compared with 74% in the nonpodiatric group. Survival probabilities at 36 months were 26.3% vs 22.8% (P < .001, unadjusted Kaplan-Meier survival analysis). In multivariate regression analysis, foot and ankle care was associated with an 11% lower likelihood of death and/or amputation (hazard ratio [HR], 0.89 95% CI, 0.84-0.93) and a 9% lower likelihood of major amputation (above or below knee) (HR, 0.91; 95% CI, 0.84-0.99) than those who did not. The findings of this study suggest that patients with kidney failure at risk for DFUs who receive foot and ankle care from podiatrists may be associated with a reduced likelihood of diabetes-related amputations.

Tolerability of vortioxetine compared to selective serotonin reuptake inhibitors in older adults with major depressive disorder (VESPA): a randomised, assessor-blinded and statistician-blinded, multicentre, superiority trial

Major depressive disorder (MDD) is prevalent and disabling among older adults. Standing on its tolerability profile, vortioxetine might be a promising alternative to selective serotonin reuptake inhibitors (SSRIs) in such a vulnerable population. We conducted a randomised, assessor- and statistician-blinded, superiority trial including older adults with MDD. The study was conducted between 02/02/2019 and 02/22/2023 in 11 Italian Psychiatric Services. Participants were randomised to vortioxetine or one of the SSRIs, selected according to common practice. Treatment discontinuation due to adverse events after six months was the primary outcome, for which we aimed to detect a 12% difference in favour of vortioxetine. The study was registered in the online repository clinicaltrials.gov (NCT03779789). The intention-to-treat population included 179 individuals randomised to vortioxetine and 178 to SSRIs. Mean age was 73.7 years (standard deviation 6.1), and 264 participants (69%) were female. Of those on vortioxetine, 78 (44%) discontinued the treatment due to adverse events at six months, compared to 59 (33%) of those on SSRIs (odds ratio 1.56; 95% confidence interval 1.01-2.39). Adjusted and per-protocol analyses confirmed point estimates in favour of SSRIs, but without a significant difference. With the exception of the unadjusted survival analysis showing SSRIs to outperform vortioxetine, secondary outcomes provided results consistent with a lack of substantial safety and tolerability differences between the two arms. Overall, no significant differences emerged in terms of response rates, depressive symptoms and quality of life, while SSRIs outperformed vortioxetine in terms of cognitive performance. As opposed to what was previously hypothesised, vortioxetine did not show a better tolerability profile compared to SSRIs in older adults with MDD in this study. Additionally, hypothetical advantages of vortioxetine on depression-related cognitive symptoms might be questioned. The study's statistical power and highly pragmatic design allow for generalisability to real-world practice. The study was funded by the Italian Medicines Agency within the "2016 Call for Independent Drug Research".

Cardiac Arrest-Associated Coagulopathy Could Predict 30-day Mortality: A Retrospective Study from Medical Information Mart for Intensive Care IV Database.

Cardiac arrest (CA) can activate the coagulation system. Some coagulation-related indicators are associated with clinical outcomes. Early evaluation of patients with cardiac arrest-associated coagulopathy (CAAC) not only predicts clinical outcomes, but also allows for timely clinical intervention to prevent disseminated intravascular coagulation. To assess whether CAAC predicts 30-day cumulative mortality. From the Medical Information Mart for Intensive Care IV (MIMIC-IV) database, we conducted a retrospective cohort study from 2008 to 2019. Based on international normalized ratio (INR) value and platelet count, we diagnosed CAAC cases and made the following stratification of severity: mild CAAC was defined as 1.4 > INR≧1.2 and 100,000/µL < platelet count≦150,000/µL; moderate CAAC was defined with either 1.6 > INR≧1.4 or 80,000/µL < platelet count≦100,000/µL; severe CAAC was defined as an INR≧1.6 and platelet count≦80,000/µL. A total of 1485 patients were included. Crude survival analysis showed that patients with CAAC had higher mortality risk than those without CAAC (33.0% vs 52.0%, P < 0.001). Unadjusted survival analysis showed an incremental increase in the risk of mortality as the severity of CAAC increased. After adjusting confounders (prehospital characteristics and hospitalization characteristics), CAAC was independently associated with 30-day mortality (hazard rate [HR] 1.77, 95% confidence interval [CI] 1.41-2.25; P < 0.001); moderate CAAC (HR 1.48, 95% CI 1.09-2.10; P = 0.027) and severe CAAC (HR 2.22, 95% CI 1.64-2.97; P < 0.001) were independently associated with 30-day mortality. The presence of CAAC identifies a group of CA at higher risk for mortality, and there is an incremental increase in risk of mortality as the severity of CAAC increases. However, the results of this study should be further verified by multicenter study.

Trends and Outcomes of Combined Heart-Kidney and Heart-Lung Transplantation Over the Past Two Decades

IntroductionCombined heart-kidney transplantation (HKTx) and combined heart-lung transplantation (HLTx) remain the definitive therapy for patients with end-stage heart failure with concomitant end-stage renal or lung failure. We sought to study trends and outcomes of HKTx and HLTx over the last two decades. MethodsThe United Network for Organ Sharing registry was used to identify all adult patients (aged >18 y) who underwent HKTx and HLTx between 2001 and 2021. Patients were divided into 5-y groups by the year of transplantation (2001-2006, 2007-2011, 2012-2016, and 2017-2021). Primary outcome was 1-y posttransplantation mortality. Kaplan-Meier and multivariable Cox proportional hazards models were used for unadjusted and risk-adjusted survival analyses, respectively. ResultsA total of 2301 HKTx and 567 HLTx patients were included. Between 2001 and 2021, HKTx volume increased from 25 to 344 patients (P < 0.001) and centers performing HKTx increased from 19 to 76 (P < 0.001). On unadjusted analysis, 1-y survival after HKTx improved from 86.7% in 2001-2006 to 89.0% in 2017-2021 (log-rank, P = 0.005). On risk-adjusted analysis, the hazard ratio of 1-y mortality for 2017-2021 was 0.62 (0.39-1.00, P = 0.048) compared with that for 2001-2006. Between 2001 and 2021, HLTx volume increased from 21 to 43 patients (P < 0.001) and centers performing HLTx increased from 12 to 20 (P = 0.047). On unadjusted analysis, 1-y survival after HLTx improved from 68.9% in 2001-2006 to 83.9% in 2017-2021 (log-rank, P = 0.600). On risk-adjusted analysis, the hazard ratio of 1-y mortality for 2017-2021 was 0.37 (0.21-0.67, P = 0.001) compared with that for 2001-2006. ConclusionsOver the last two decades, HKTx volume substantially increased and HLTx experienced resurgent growth. One-year survival persistently improved for both procedures, especially over the past 5 y.

Early Experience and Lessons Learned Using Implanted Hemodynamic Monitoring in Patients With Fontan Circulation.

Data on the use of implanted hemodynamic monitoring (IHM) in patients with Fontan circulation are limited. This study reports our experience using the CardioMEMS HF system in adults with Fontan circulation. This single-center, retrospective study evaluated heart failure hospitalizations, procedural complications, and device-related complications in patients with Fontan circulation referred for IHM placement (2015-2022). The association of pulmonary artery pressure (by most recent catheterization and median IHM pressure within 30 days of placement) with both death and follow-up Model for End-Stage Liver Disease Excluding International Normalized Ratio score were evaluated. Of 18 patients referred for IHM placement, 17 were successful (median age, 30 [range 21-48] years, 6 women). Procedural complications (access site hematomas, pulmonary artery staining) occurred in 3 patients, without device-related procedural complications. In follow-up (median, 35 [range, 6-83] months), 1 patient developed a pulmonary embolism (possibly device-related). Heart failure hospitalizations/year were similar before and after IHM (median, 1 [interquartile range, 0-1.0] versus 0.6 [0-2.3]; P=0.268), though only 46% of heart failure hospitalizations had associated IHM transmissions. IHM pressures were associated with Model for End-Stage Liver Disease Excluding International Normalized Ratio scores (R2=0.588, P<0.001), though catheterization pressures were not (R2=0.140, P=0.139). The long-term mortality rate was 53% in this cohort. On unadjusted survival analysis, IHM pressures ≥18 mm Hg were associated with mortality (log rank P=0.041), which was not reproduced with catheterization pressures (log rank P=0.764). In patients with Fontan circulation, IHM did not reduce heart failure hospitalizations, though patient adherence to transmission was low. Device-related complications were low. IHM pressures may better represent real-life conditions compared with catheterization given associations with mortality and Model for End-Stage Liver Disease Excluding International Normalized Ratio score.

Osteoporosis and Total Knee Arthroplasty: Higher 5-Year Implant-Related Complications

BackgroundThe risk of revision surgery in patients who have osteoporosis after total knee arthroplasty (TKA) is understudied. Our aim was to compare the 5-year cumulative risk of revision surgery after TKA in patients who have preoperative osteoporosis. MethodsA national administrative claims database was queried for patients undergoing primary TKA from 2010 to 2021. There were 418,054 patients included, and 41,760 (10%) had osteoporosis. The 5-year incidence of revision surgery was examined for all-causes, periprosthetic fracture (PPF), aseptic loosening, and periprosthetic joint infection (PJI). A multivariable analysis was conducted using Cox proportional hazards models. Hazards ratios (HRs) were reported with 95% confidence intervals (CIs). ResultsThe 5-year rate of all-cause revision surgery was higher for patients who had osteoporosis (HR 1.1, 95% CI: 1.0 to 1.2), however, the highest risk of revision surgery was seen for PPF (HR 1.8, 95% CI: 1.6 to 2.1). Patients who had osteoporosis also had elevated risk of revision surgery for PJI (HR 1.2, 95% CI: 1.1 to 1.3) and aseptic loosening (HR 1.2, 95% CI: 1.1 to 1.3). Osteoporosis was independently associated with PJI and aseptic loosening at a higher rate in obese patients. ConclusionsIn unadjusted survival analysis, those who had osteoporosis have a marginally lower risk of all-cause revision surgery. However, after controlling for age, sex and comorbidities, patients who had osteoporosis have a nearly 2-fold increased risk of 5-year revision for PPF after TKA, and mildly increased risk of revision for all causes, aseptic loosening, and PJI. Obesity may also modulate this association. Future studies should determine the extent to which treatment of osteoporosis modifies these postoperative outcomes.

Initial Management Strategy and Long-Term Outcomes in 186 Cases of Spontaneous Coronary Artery Dissection

Spontaneous coronary artery dissection (SCAD) is a rare but important nonatherosclerotic cause of acute coronary syndrome. Indications for revascularization and long-term outcomes of SCAD remain areas of active investigation. We report our experience with initial management strategy and long-term outcomes in SCAD. We reviewed all patients treated at our institution from 1996-2021 with a SCAD diagnosis. Demographics, comorbidities, clinical presentations, angiography findings, and management strategies were obtained by chart review. The primary outcome was a composite of cardiac death, recurrent/progressive SCAD, subsequent diagnosis of congestive heart failure, or subsequent/repeat revascularization after the initial management. Unadjusted Kaplan-Meier survival analysis was performed. Of 186 patients with a SCAD diagnosis treated at our institution, 149 (80%) were female. Medical management was the initial treatment in 134 (72.0%) patients, percutaneous coronary intervention (PCI) in 43 (23.1%), and coronary artery bypass grafting in 9 (4.8%). Surgery/PCI intervention was associated with younger age (38.8 vs 47.7 years, P = 0.01), ST elevation myocardial infarction on presentation (67.0% vs 34.0%, P < 0.001), lower ejection fraction (45.0% vs 55.0%, P = 0.002), and left anterior descending coronary artery dissection (75.0% vs 51.0%, P = 0.006). Ten-year freedom from our composite outcome was similar between revascularized patients and those managed with medical therapy (P = 0.36). Median follow-up time was 4.5 years. SCAD in the setting of ST elevation myocardial infarction, left anterior descending coronary artery involvement, or decreased cardiac function suggests greater ischemic insult and was associated with initial percutaneous or surgical revascularization. Despite worse disease on initial presentation, long-term outcomes of patients undergoing revascularization are similar to medically managed patients with SCAD.

Does Prescription Length of Buprenorphine Influence Treatment Outcomes in Opioid Use Disorder? A Retrospective Cohort Study from North India

Objective Buprenorphine (BUP) effectively suppresses non-prescription opioid use and increases treatment retention in opioid use disorder (OUD). However, short prescription length may interfere with treatment retention and recovery. We wanted to examine whether the outcomes of BUP treatment differ in high (HPL up to 4 wk) and low-prescription (LPL 1–2 wk) length groups. Methods We compared time to treatment discontinuation (TD), non-prescription opioid-positive urine screen, buprenorphine-negative urine screen, and self-reported non-prescription opioid use between two different cohorts of LPL (case record: June 2018 to August 2019; n = 105; observation endpoint: 31 October 2019) and HPL groups (case record: June 2020 to Aug 2021; n = 133; observation endpoint: 31 October 2021). We used Kaplan-Meier survival analysis and log-rank tests for between-group comparisons. We used Cox regression analysis to adjust for age, opioid potency, comorbidities, family income, and marital status. Results Subjects’ age and buprenorphine dose were significantly lower, and the percentage of high-potency opioid users was significantly higher in the LPL group. In the unadjusted survival analysis, the median time to BUP discontinuation in the HPL was longer than that of the LPL [LPL= 22.4 ± 4.3 wk; HPL = 33.1 ± 8.5 wk; χ2(1)= 5.7; p=.02]. The survival distributions of other outcomes did not differ between groups. When adjusted for covariates, neither the prescription length nor other covariates independently predicted any treatment outcome. Conclusion Higher prescription length might be associated with longer treatment retention. We provide preliminary evidence to support greater flexibility in BUP treatment, enhancing its scalability and attractiveness.

Replicating the timing of androgen deprivation therapy randomized trial (TROG 03.06 and VCOG PR 01-03 [TOAD]) for recurrent prostate cancer using real-world observational data.

e17090 Background: The landmark TOAD trial (Lancet Oncol 2016) demonstrated an overall survival benefit for immediate compared to delayed androgen deprivation therapy (ADT) for patients with recurrent prostate cancer or unsuitable for curative treatment. However, the extent to which TOAD trial results can be replicated in real-world population-based observational data is unknown. For these reasons, we used TOAD trial data and criteria to define a similar retrospective cohort of men with rising PSA after definitive treatment of localized prostate cancer to compare immediate versus delayed ADT for recurrent non-metastatic disease. Methods: We used two data sources to conduct this study: 1) TOAD trial data, and 2) national electronic health record, cancer registry, administrative, pharmacy, and laboratory data for men treated with radical prostatectomy or radiotherapy for localized prostate cancer and laboratory confirmed biochemical recurrence (BCR) between 2005- 2015 in the Veterans Health Administration. We defined BCR according to guidelines and used National Death Index data through 2019 for survival outcomes. We designated randomization to the ‘immediate’ and ‘delayed’ arms for men receiving ADT within (immediate) or after (delayed) 2 years of BCR in the observational data. We used Cox proportional hazards regression models adjusting for age, PSA at BCR, comorbidities, and Gleason score, stratified by prior ADT exposure, to compare survival outcomes for immediate versus delayed ADT. Results: We identified 9,866 men with BCR after radical prostatectomy, 3,431 after radiotherapy alone, and 2,703 after radiotherapy and adjuvant ADT. The mean age at randomization for the TOAD cohort was older (74.8 vs. 75.9 years, delayed vs. immediate) compared to our observational cohort (68.1 vs. 67.0 years, delayed vs. immediate). In unadjusted survival analyses, we found both overall and prostate cancer-specific survival were higher among patients with delayed ADT (log-rank p-value &lt; 0.001 for both). Our multivariable survival models among men with and without prior ADT exposure also demonstrated survival benefit associated with delayed ADT (prior ADT exposure, adjusted hazard ratio (aHR) 2.3, 95% confidence interval (CI) 1.7, 3.0, no prior ADT exposure 2.6, 95% CI 2.4, 2.8). Conclusions: The benefit of immediate ADT administration compared to delayed as reported within the TOAD study was not found in a comparable observational cohort of men with non-metastatic recurrent prostate cancer. Even after multivariable adjustment, we found clear association of delayed ADT administration with improved survival outcomes suggesting selection bias and unobserved confounding, or that delayed ADT may be warranted for selected patient populations necessitating further investigation. Source of Funding: NCI R01 CA242559.

Ethnic disparities in biomarker testing and targeted therapy use in metastatic lung adenocarcinoma: A 2014-2021 analysis.

e21216 Background: Racial and ethnic disparities have been demonstrated to be widespread in lung cancer, including in the US. Despite insurance coverage for standard biomarker testing, testing rates remain low in minority populations. This work sought to analyze institutional data to assess whether there existed ethnic disparities in biomarker testing rates and receipt of targeted therapy between Hispanic/Latino and non-Hispanic/Latino patients of metastatic lung adenocarcinoma (mAdenoCa). Methods: A retrospective study was conducted and reported following ‘strengthening the reporting of observational studies in epidemiology’ (STROBE) guidelines. All Hispanic white and non-Hispanic white patients of mAdenoCa seen at our tertiary care institution in South Florida from 01/2014 to 12/2021 were identified and included through Guardian Research Network (GRN) platform. Socio-demographic, clinicopathological, and tumor molecular features along with treatment-related characteristics were analyzed via descriptive and comparative statistics. Results: A total of 268 mAdenoCa patients were included, of which 179 patients were Hispanic or Latino and 89 were not Hispanic or Latino. Biomarker testing data is reported in the table. Data of MET, KRASG12C, VKIRAS, and HER3 was not available in all cases. The unadjusted product-limit survival analysis indicated worse outcomes for Hispanic whites as compared to non-Hispanic counterparts. There were no differences found regarding targeted therapy use in either population. Conclusions: While metastatic lung adenocarcinoma patients at our center showed no differences in biomarker testing or targeted therapy use, the non-availability of data regarding several key mutations indicates a major dearth of testing. Future studies need to evaluate actionable strategies for improving the existing low testing rates in patients with mAdenoCa, particularly in racial and ethnic minorities. [Table: see text]

Mitigating disparities in breast cancer treatment at an academic safety-net hospital.

Among women with non-metastatic breast cancer, marked disparities in stage at presentation, receipt of guideline-concordant treatment and stage-specific survival have been shown in national cohorts based on race, ethnicity, insurance and language. Little is published on the performance of safety-net hospitals to achieve equitable care. We evaluate differences in treatment and survival by race, ethnicity, language and insurance status among women with non-metastatic invasive breast cancer at a single, urban academic safety-net hospital. We conducted a retrospective study of patients with invasive ductal or lobular breast cancer, diagnosed and treated between 2009 and 2014 at an urban, academic safety-net hospital. Demographic, tumor and treatment characteristics were obtained. Stage at presentation, stage-specific overall survival, and receipt of guideline-concordant surgical and adjuvant therapies were analyzed. Chi-square analysis and ANOVA were used for statistical analysis. Unadjusted survival analysis was conducted by Kaplan-Meier method using log-rank test; adjusted 5 year survival analysis was completed stratified by early and late stage, using flexible parametric survival models incorporating age, race, primary language and insurance status. 520 women with stage 1-3 invasive breast cancer were identified. Median age was 58.5years, 56.1% were non-white, 31.7% were non-English-speaking, 16.4% were Hispanic, and 50.1% were Medicaid/uninsured patients. There were no statistically significant differences in stage at presentation between age group, race, ethnicity, language or insurance. The rate of breast conserving surgery (BCS) among stage 1-2 patients did not vary by race, insurance or language. Among patients indicated for adjuvant therapies, the rates of recommendation and completion of therapy did not vary by race, ethnicity, insurance or language. Unadjusted survival at 5 years was 93.7% for stage 1-2 and 73.5% for stage 3. Adjusting for age, race, insurance status and primary language, overall survival at 5 years was 93.8% (95% CI 86.3-97.2%) for stage 1-2 and 83.4% (95% CI 35.5-96.9%) for stage 3 disease. Independently, for patients with early- and late-stage disease, age, race, language and insurance were not associated with survival at 5-years. Among patients diagnosed and treated at an academic safety-net hospital, there were no differences in the stage at presentation or receipt of guideline-concordant treatment by race, ethnicity, insurance or language. Overall survival did not vary by race, insurance or language. Additional research is needed to assess how hospitals and healthcare systems mitigate breast cancer disparities.