Baseline Patient Characteristics Research Articles

Collaterals at angiography guide clinical outcomes after endovascular stroke therapy in HERMES

BackgroundRobust collateral circulation has been linked with better reperfusion and clinical outcomes. It remains unclear how individual assessments of collateral circulation may be translated into clinical practice.MethodsThe pooled Highly Effective...

Factors Affecting Operating Room Scheduling Accuracy for Primary and Revision Total Knee Arthroplasty: A Retrospective Study.

Optimizing operating room (OR) scheduling accuracy is important for improving OR efficiency and maximizing value of total knee arthroplasty (TKA). However, data on factors that may impact TKA OR scheduling accuracy are limited. A retrospective review of 7655 knee arthroplasties (6999 primary TKAs and 656 revision TKAs) performed between January 2020 and May 2023 was conducted. Patient baseline characteristics, surgeon experience (years in practice), as well as actual vs scheduled OR times were collected. Actual OR times that were at least 15% shorter or longer than scheduled OR times were considered to be clinically important. Logistic regression analyses were employed to assess the influence of specific patient and surgeon factors on OR scheduling inaccuracies. Using adjusted odds ratio, patients with primary TKA who had a lower body mass index (P<.001) were independently associated with overestimation of scheduled surgical time. Conversely, younger age (P<.001), afternoon procedure start time (P<.001), surgeons with less than 10 years of experience (P=.037), and higher patient body mass index (P<.001) were associated with underestimation of scheduled surgical time. For revision TKA, female sex (P=.021) and morning procedure start time (P=.038) were associated with overestimation of scheduled surgical time, while surgeons with less than 10 years of experience (P=.014) and patients who underwent spinal/epidural/block anesthesia (P=.038) were associated with underestimation of scheduled surgical time. This study highlights patient, surgeon, and intraoperative variables that impact the accuracy of scheduling for TKA procedures. Health systems should take these variables into consideration when creating OR schedules to fully optimize resources and available space. [Orthopedics. 202x;4x(x):xx-xx.].

Prescription patterns of SGLT2 inhibitors in patients with type 2 diabetes and heart failure with reduced ejection fracture admitted to a tertiary care centre in Ontario, Canada

ObjectiveTo assess early adoption patterns of SGLT2 inhibitors (SGLT2i) in eligible patients with type 2 diabetes (T2DM) and heart failure with reduced ejection fracture (HFrEF) and identify gaps in practice. MethodsA retrospective chart review of patients with T2DM and HFrEF admitted with decompensated heart failure to The Ottawa Hospital under Cardiology or GIM from June 2019-May 2021 was conducted. Patterns were assessed at 8-months intervals (1 period before the release of Diabetes Canada 2020 guidelines and 2 periods afterwards). Baseline patient characteristics, co-morbidities and prescriber information was collected. ResultsOf the 98 patients that met the inclusion criteria, 36.7% had a prescription for an SGLT2i either on admission, discharge or follow-up. Trends showed a gradual increase over time. On admission, 9.8% of patients were on an SGLT2i in period 1, 19.2% in period 2 and 23.3% in period 3. Patients receiving a prescription for SGLT2i on discharge were 0.0% in period 1, 10.0% in period 2 and 9.5% in period 3, all which were admitted under Cardiology. On follow-up, 13.9% of eligible patients were started on an SGLT2i in period 1, 21.1% in period 2 and 35.0% in period 3. Endocrinology was the main prescriber of SGLT2i in the outpatient setting, followed by Cardiology. ConclusionsOverall, trends show a slow but steady increase in early prescriptions of SGLT2i. However, most eligible patients were not started on therapy during our study period with variability in practice between specialties, highlighting opportunities to boost uptake in the future.

P-217 Keep calm and carry on: assessing the effect of below-benchmark vitrified/warmed donor oocyte survival rates in subsequent laboratory and clinical key performance indicators

Abstract Study question When we experience below benchmark donor oocyte survival rates, are the laboratory and clinical outcomes of the recipient cycle affected? Summary answer Donor-oocyte cryo-survival rates below the benchmark (95-100%) result in slightly lower laboratory KPIs, equivalent live birth rates (LBR) and lower cumulative LBR (CLBR) per cycle. What is known already The use of vitrified/warmed donor oocytes allows overcoming many logistic challenges, but it is hindered by the loss of oocytes due to degeneration after warming. The 2012 Vienna Consensus established the benchmark rate of oocyte survival at 95-100%, competency level at &amp;gt; 85%. Results of &amp;lt; 85% cryo-survival are considered below competency, &amp;lt;70% can be considered poor, and &amp;lt;50% very poor. Below-benchmark rates of survival may not only limit the number of donor oocytes for the cycle, but they can also translate into lower per-oocyte cycle KPIs if the lower survival correlates with lower performance of the surviving oocytes. Study design, size, duration We analyzed 12690 vitrified-warmed donor oocyte recipient cycles, encompassing a total 144793 vitrified/warmed donor oocytes, carried out in a network of European private IVF units from 2018-2022. Cycles with PGT-A and spermatozoa from testicular biopsy were excluded. The primary endpoint of the study was the blastocyst utilization rate per 2PN zygote. Secondary endpoints were fertilization rate, live birth rate after the first single blastocyst transfer (SET-LBR) of each cycle, and cumulative LBR (CLBR). Participants/materials, setting, methods In all cases, fertilization was carried out by ICSI, and embryos were cultured to the blastocyst stage at low oxygen tension. Blastocysts with good or fair quality (A, B &amp; C by ASEBIR Criteria) were considered usable (transferred + cryopreserved blastocyts / zygotes). Differences in proportions were analyzed using chi-square and the adjusted odds ratio (OR) was calculated using multivariable logistic regression. Main results and the role of chance Baseline donor and patient characteristics such as age, stimulation duration and dose, total donor oocytes per cycle, male factor, and fresh/frozen/donor spem were compared between groups and adjusted for when necessary. The mean number of warmed oocytes per cycle was 11.4±3.22 with a mean survival rate of 89.2%. More oocytes per cycle were consumed in the lower survival groups, yet the total oocytes available for ICSI was smaller in the below competency, poor and very poor survival groups. There were differences in the proportion of usable blastocysts per zygote amongst the survival rate groups (benchmark: 48.9%; competence: 47.0%, below-competence: 46.0%; poor: 43.6%; very-poor:43.6%, p &amp;lt; 0.001). Fertilization rates also differed between survival groups (benchmark: 76.9%; competence: 76.5%, below-competence: 75.6%; poor: 74.7%; very-poor:75.4%, p &amp;lt; 0.001) The adjusted odds ratio of live birth on the first SET of the cycle was not lower to the benchmark survival group in all the lower survival groups (Benchmark: 40.9%; Competence: OR:0.995; 95%CI:0.971-1.018; below-competence: OR:0.996; 95%CI:0.970-1.023; poor: OR:1.044; 95%CI:1.003-1.086, and very-poor: OR:1.069; 95%CI:0.976-1.170). The CLBR decreased in lower survival groups, with 80.8% for the benchmark survival group, 80.3% (p = 0.539) for competence, 76.2% (p &amp;lt; 0.001) for below-competence, 72.5% (p &amp;lt; 0.001) for poor, and 74.8% (p = 0.056) for very-poor. Limitations, reasons for caution These results are limited to a donor-oocyte population. Wider implications of the findings Lower oocyte-cryo-survival rates resulted in a lower total number of usable blastocysts obtained for the recipient, and consequently, lower CLBR. However, the competence of surviving oocytes is encouraging, with laboratory KPIs in very close range irrespectively of the cohort survival rates, and similar implantation potential of the obtained blastocysts. Trial registration number not applicable

P-310 Impact of adenomyosis on the live birth rate during management by in vitro fertilization : a French study

Abstract Study question Evaluate the impact of adenomyosis on the likelihood of live birth after a fresh embryo transfer. Summary answer Adenomyosis reduces the live-birth rate. The location of adenomyosis and the type of protocol appears to have no impact on the live birth rates. What is known already The prevalence of adenomyosis varies between 7 and 27%, and affects 25% of infertile women. Its impact on fertility remains debated. According to some studies, it leads to a lower pregnancy rate, a doubling of the spontaneous miscarriage rate and a lower live birth rate as compared to non-adenomyosis women. However according to some authors adenomyosis does not reduce the live birth rate. Similarly, the impact of the location of adenomyosis remains debated. On the impact of the stimulation protocol, several studies have shown that the use of GnRH agonist improves the live birth rate in patients with adenomyosis. Study design, size, duration This is a retrospective, descriptive and observational study, managed at the fertility department of Dijon University Hospital between January 2015 and March 2020. Systematically, the women infertility cause was assessed. We compared the group of patients with adenomyosis (i.e. symptomatic adenomyosis completed with a 3D ultrasound within a maximum of 1 year prior to management) with controls (i.e. patients treated for another cause of infertility). Ultrasound was performed by the same two experienced operators. Participants/materials, setting, methods We included 340 patients aged 18-41 years. Data concerning live births and type of stimulation protocol were collected from the patient’s electronic medical and therapeutic records. MUSA classification was used to determine whether the adenomyosis was localized or diffuse. The primary endpoint of this study was the live-birth rate (LBR) after fresh embryo transfer. The implantation and miscarriage rates were also compared. Main results and the role of chance We included 92 patients in adenomyosis group, and 248 patients in control group. Baseline characteristics of patients including women age, BMI and smoking habits were comparable in both groups. Moreover, no difference was found on the mean number of mature oocytes and embryos between the two groups. LBR after fresh embryo transfer was significantly lower in the adenomyosis group than in the control (34.8 % versus 41.5%, respectively, p = 0,02). There was no significant difference in implantation rate (35.7% versus 37,4%, p = 0.76). Early miscarriage rate (&amp;lt;12 weeks of amenorrhea) was higher in the control group than the adenomyosis group (15.3 versus 7.5, p = 0.012). Concerning late miscarriage (&amp;gt;12 weeks of amenorrhea), we observed 3 medical termination of pregnancy (all for fetal malformation) and 1 miscarriage (10%) in the adenomyosis group and 1 miscarriage (0.81%) in the control group (p = 0.02). Subgroup analyses showed no decrease in LBR according to adenomyosis location (32.7% versus 37.2% in the diffuse and localized groups, respectively, p = 0.46). Limitations, reasons for caution Even though our cohort is a good reflection of the all-French population of Burgundy since all patients are treated at the fertility center of Dijon. Despite its retrospective nature and the small number of included adenomyosis-patients, the ultrasound scans were performed by two experienced operators that reduced inter-observer variability. Wider implications of the findings It would be useful to carry out a prospective study including more patients to better assess the impact of location on implantation. It would also be interesting to evaluate neonatal and obstetrical complications, especially the late miscarriage issue requiring further investigation. Trial registration number non-clinical trials

O-296 The benefits of higher concentrations of synthetic serum substitutes in post-warming embryo culture and transfer media: a retrospective study of 864 frozen blastocyst transfer cycles

Abstract Study question Does a higher concentration of synthetic serum substitutes (SSS) in post-warming embryo culture and transfer media improve clinical outcomes in frozen blastocyst transfer (FBT) cycles? Summary answer Increased SSS concentration in post-warming embryo culture and transfer media reduces miscarriage rate in FBT cycles and improves ongoing pregnancy rate in euploid blastocyst transfer. What is known already Several studies showed increased clinical pregnancy rates with the use of complex protein supplementation such as SSS in embryo culture media. Nevertheless, there is a lack of standardization on their concentrations. The range of concentrations employed is strikingly wide, spanning from 5% to 50%. Moreover, no studies investigating different SSS supplement concentrations in post-warming embryo culture and transfer media in FBT cycles are available. These uncertainties warrant further investigation in this field. Study design, size, duration This retrospective study included 864 patients undergoing vitrified-warmed euploid (n = 102) and untested (n = 762) blastocyst transfers between September 2022 and August 2023. The cohort was divided based on the concentration of SSS used in post-warming embryo culture and transfer media: 10% (n = 415) and 20% (n = 449). The exclusion criteria were ICSI-cycles performed with surgically retrieved or frozen sperm, gamete donation and vitrified-warmed oocyte cycles. Prior to embryo transfer, warmed blastocysts were cultured for 2-3 hours. Participants/materials, setting, methods Treatment allocation to 10% or 20% SSS groups followed an alternating regimen. To reduce any pre-existing differences between the two groups, a propensity-score (PS) analysis was performed, targeting unbiased treatment effect estimates. Variables included in the PS were: maternal age, maternal BMI, infertility type, transfer day, endometrial preparation, blastocyst quality, and the operators for biopsy, warming, and transfer. Main results and the role of chance Patient baseline characteristics were evenly distributed in the two study groups. After the PS-based analysis, no statistically significant differences in ongoing pregnancy rates for both overall and untested blastocyst transfers were observed between 10% and 20% SSS groups. However, the 20% SSS group exhibited a significantly lower miscarriage rate in overall FBTs [OR = 0.61, 95% CI (0.37-1.00), p-value=0.050] and a higher ongoing pregnancy rate in euploid blastocyst transfers [OR = 3.48, 95% CI (1.30-9.35), p-value=0.013]. A mild trend of an increased miscarriage rate was also observed in both euploid and untested blastocyst transfers in the 10% SSS group compared to the 20% SSS group [OR = 2.834, 95% CI (0.651-12.337), p-value=0.165; OR = 1.558, 95% CI (0.897-2.705), p-value=0.115 respectively]. Limitations, reasons for caution The study is limited by its retrospective design and a lack of randomization, although a PS-based analysis may mitigate such a weakness. Not considering live birth rate as outcome and protein concentrations higher than 20% and lower than 10% might represent other study limitations. Wider implications of the findings To our knowledge, this is the first study investigating the impact of varying protein supplementation concentrations in post-warming embryo culture and transfer media on clinical outcomes in FBTs. Our findings suggest that higher serum concentrations improve the likelihood of ongoing pregnancy, especially in blastocysts undergoing stressful manipulations such as biopsy. Trial registration number not applicable

P-418 What is the optimal midluteal phase circulating progesterone level during a fresh IVF cycle? The answer differs from what one expects in a natural cycle

Abstract Study question Do midluteal phase circulating progesterone (P4) levels relate to the fresh embryo transfer clinical outcome and is rescue P4 useful in such cases? Summary answer Live birth rate (LBR) was significantly lower when P4 levels were below 20ng/ml and did not seem to benefit from rescue intramuscular P4. What is known already Preceding literature on the predictive value of midluteal P4 for LBR has shown conflicting results and frequently included small sample sets and heterogeneous ovarian stimulation protocols. The findings reported ranged from the lack of an association between P4 serum levels and clinical outcome to worse success rates seen either in the groups with the highest or the lowest P4 in midluteal phase. Furthermore, while rescue P4 has been empirically proposed, it has lacked formal assessment thus far. Study design, size, duration In total, 652 patients who underwent a fresh single blastocyst transfer in an IVF cycle in our center between 2014 and 2021 were included in this retrospective cohort study. All were GnRH-antagonist cycles using hCG trigger and luteal support with micronized vaginal progesterone 200mg twice daily. Rescue intramuscular progesterone was systematically administered whenever low midluteal P4 (below 1 standard deviation of the center’s mean) levels were detected. Participants/materials, setting, methods The cycles were subdivided into three groups according to the midluteal P4 levels: &amp;lt;10ng/ml, 10-20ng/ml and &amp;gt;20ng/ml. The primary outcome assessed was LBR, with secondary outcomes including clinical pregnancy (CPR) and pregnancy loss rates. Maternal age and body mass index (BMI), year of treatment, ovarian response, endometrial thickness, cause of infertility and embryo quality were controlled for using multivariable logistic regression. Main results and the role of chance The mean age ± standard deviation of patients was 36.8±3.8 years, while mean weight and BMI were 63.2±11.5kg and 23.3±3.9kg/m2, respectively. LBR in the group with P4&amp;gt;20ng/ml (46.5%) was significantly higher than in the groups with low and intermediate P4 serum levels (23.1% and 28.1%, respectively, p &amp;lt; 0.001). The same was true for CPR (54.5%, 30.8% and 37.9%, respectively, p &amp;lt; 0.001). Conversely, the rate of pregnancy loss in the group with P4&amp;gt;20ng/ml (23.8%) was significantly lower than in the groups with low and intermediate P4 levels (42.6% and 37.5%, respectively, p = 0.018). The multivariable logistic regression confirmed that, after controlling for the confounding variables described above, P4&amp;gt;20ng/ml remained significantly associated with a higher LBR (OR: 2.285; 95% CI: 1.506-3.469) and a lower pregnancy loss rate (OR: 0.488; 95% CI: 0.273-0.873), irrespective of the use of rescue IM P4. Finally, a multivariable linear regression analysis of the patients baseline characteristics suggested that the only parameter predictive of midluteal P4 levels was the female patients’ weight, with an inverse relationship (adjusted regression coefficient: -0,012; 95% CI: -0,016/-0,009). Limitations, reasons for caution As the pituitary suppression, ovulation trigger and luteal support protocols used in the cycles included in the study were homogeneous (in order to maximize the internal validity of the results), this limits the extrapolibility of the results to other stimulation protocols. Furthermore, we caution that this is a retrospective study. Wider implications of the findings The usefulness of both midluteal P4 serum measurements and rescue P4 should continue to be assessed. The reasons behind the need for higher levels of P4 in a fresh cycle, when compared to natural cycles, must also be investigated. Luteal support may require personalization according to female body weight. Trial registration number Not Applicable

Irreversible Electroporation as a Valid Treatment Option for Hepatic Epithelioid Hemangioendothelioma: An International Multicenter Experience.

Hepatic epithelioid hemangioendothelioma (HEHE) is a rare tumor with currently no established standard of care. This international multicenter retrospective study assesses the use of percutaneous irreversible electroporation (IRE) as an ablative tool to treat HEHE and provides a clinical overview of the current management and role of IRE in HEHE treatment. Between 2017 and 2023, 14 patients with 47 HEHE tumors were treated with percutaneous IRE using CT-scan guidance in 23 procedures. Baseline patient and tumor characteristics were evaluated. Primary outcome measures included safety and effectiveness, analyzed using Common Terminology Criteria for Adverse Events (CTCAE) and treatment response by mRECIST criteria. Secondary outcome measures included technical success, post-treatment tumor sizes and length of hospital stay. Technical success was defined as complete ablation with an adequate ablative margin (intentional tumor free ablation margin > 5mm). IRE treatment resulted in technical success in all tumors. Following a median follow-up of 15months, 30 tumors demonstrated a complete response according to mRECIST criteria. The average tumor size pre-treatment was 25.8mm, accompanied by an average reduction in tumor size by 7.5mm. In 38 out of 47 tumors, there was no evidence of local recurrence. In nine tumors, residual tumor was present. There were no cases of progressive disease. Median length of hospital stay was one day. Only one grade 3 CTCAE event occurred, a pneumothorax requiring chest tube placement. The current study provides evidence that IRE is a safe and efficacious minimally invasive treatment option for HEHE.

Predictors of In-Hospital Mortality in Type A Acute Aortic Syndrome: Data From the RENADA-RO Registry

This study aimed to analyse the baseline characteristics of patients admitted with acute type A aortic syndrome (ATAAS) and to identify the potential predictors of in-hospital mortality in surgically managed patients. Data regarding demographics, clinical presentation, laboratory work-up, and management of 501 patients with ATAAS enrolled in the National Registry of Aortic Dissections-Romania registry from January 2011 to December 2022 were evaluated. The primary endpoint was in-hospital all-cause mortality. Multivariate logistic regression was conducted to identify independent predictors of mortality in patients with acute Type A aortic dissection (ATAAD) who underwent surgery. The mean age was 60±11 years and 65% were male. Computed tomography was the first-line diagnostic tool (79%), followed by transoesophageal echocardiography (21%). Cardiac surgery was performed in 88% of the patients. The overall mortality in the entire cohort was 37.9%, while surgically managed ATAAD patients had an in-hospital mortality rate of 29%. In multivariate logistic regression, creatinine value (OR 6.76), ST depression on ECG (OR 6.3), preoperative malperfusion (OR 5.77), cardiogenic shock (OR 5.77), abdominal pain (OR 4.27), age ≥70 years (OR 3.76), and syncope (OR 3.43) were independently associated with in-hospital mortality in surgically managed ATAAD patients. Risk stratification based on the variables collected at admission may help to identify ATAAS patients with high risk of death following cardiac surgery.

Long- and short-term outcomes after transvenous lead extraction in a large single-centre patient cohort using the clinical frailty scale as a risk assessment tool

Background and aimsThe rate of cardiac implantable electronic device (CIED) implantations and the need for transvenous lead extraction (TLE) are growing worldwide. This study examined a large Swedish cohort with the aim of identifying possible predictors of post-TLE mortality with special focus on systemic infection patients and frailty. MethodsThis was a single centre study. Records of patients undergoing TLE between 2010 and 2018 were analysed. Statistical analyses were conducted to compare baseline characteristics of patients with different indications and identify risk factors of 30-day and 1-year mortality. ResultsA total of 893 patients were identified. Local infection was the dominant indication and pacemaker was the most common CIED. The mean age was 65 ± 16 years, 73% were male and median follow-up was 3.9 years. Heart failure was the most common comorbidity. Patients with systemic infection were significantly older, frailer and had significantly higher levels of comorbidities. 30-day mortality and 1-year mortality rates were 2.5% and 9.9%, respectively. Systemic infection and chronic kidney disease (CKD) were independently associated with 30-day and 1-year mortality. Clinical frailty scale (CFS) 5-7 correlated independently with 1-year mortality in the entire cohort and specifically in systemic infection patients. CKD, cardiac resynchronization therapy and CFS 5-7 were significant risk factors for long-term mortality (death >1 year after TLE) in multivariable analysis. ConclusionsSystemic infection, kidney failure in addition to the novel parameter of frailty were associated with post-TLE all-cause mortality. These risk factors should be considered during pre-procedure risk stratification to improve post-TLE outcomes.

Systematic screening by a heart team and a machine learning approach contribute to unraveling novel risk factors in revascularization candidates with complex coronary artery disease.

The baseline characteristics affecting mortality following percutaneous or surgical revascularization in patients with left main and / or 3‑vessel coronary artery disease (CAD) observed in real‑world practice differ from those established in randomized controlled trials (RCTs) due to the constraints of inclusion / exclusion criteria. This study aimed to assess whether systematic screening enables identification of novel and registry‑specific baseline patient characteristics influencing long‑term mortality. Least absolute shrinkage and selection operator (LASSO) regression was used to screen 42 baseline patient characteristics shared by the SYNTAX (Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) trial and a single‑center Polish registry of 1035 consecutive patients with complex CAD who received revascularization and were followed-up for 5 years. After screening, a classic Cox regression analysis was performed to examine the suitability of a linear model for predicting 5‑year mortality, which was then compared with the mortality predicted in the same cohort using the SYNTAX score II 2020 (SS2020). The 5‑year mortality rate in the registry was 12.3%, and the strongest predictors were pulmonary hypertension, chronic obstructive pulmonary disease, and insulin‑dependent diabetes. In an internal validation, the linear model constructed after LASSO screening and combined with a classic Cox regression analysis improved the prediction of 5‑year mortality, as compared with the SS2020 (concordance index of 0.92 and 0.75, respectively). A machine learning approach improved the detection of registry‑specific risk factors in all‑comer patients amenable to surgical or percutaneous revascularization who were evaluated by a heart team. The risk factors identified in RCTs are not necessarily the same as those detected in real clinical practice when systematic screening is applied.

β-blockades and the risk of atrial fibrillation in patients with cardiovascular diseases.

β-blockers have been widely used in patients with extensive cardiovascular disease (CVD) and have provided benefits. However, they are more likely to cause symptomatic bradycardia, hypotension, or glucose metabolism disorders, which may lead to an increased risk of atrial fibrillation (AF), but evidence is lacking. This study was to analyze the association between the use of β-blockers and the risk of developing AF. This nationwide, prospective cohort study utilized data from the 2013-2020 National Health and Nutrition Examination Survey (NHANES). The patients were stratified into a β-blocker treatment group (n = 2585) and a non-β-blocker treatment group (n = 8525). Univariate and multivariate logistic regression analyses were performed to identify the relationship between β-blockades and the risk of AF. Propensity matching analysis was used to balance patient baseline characteristics and to control for confounders. A total of 11,110 subjects were included in this study (mean [SD] age, 59.89 [15.07] years; 5657 [49.7%] males). A total of 111/2585 subjects developed AF in the β-blocker treatment group, and 75/8525 developed AF in the non-β-blocker treatment group (incidence rate, 4.2% vs. 0.8%). Compared with the non-β-blocker group, the β-blocker group had an increased risk of incident AF (aOR, 2.339; 95% CI, 1.614-3.410). Some sensitivity analyses also revealed consistent findings of increased AF risk associated with β-blocker treatment. The findings from this study suggest that β-blocker treatment is associated with an increased risk of incident AF and may help physicians select a modest medication for patients while also assessing the risk of AF.

CO174 Baseline Characteristics of Patients with Asthma and Prior Oral Systemic Corticosteroid Use Initiating Dupilumab in a Real-World Registry (RAPID)

CO174 Baseline Characteristics of Patients with Asthma and Prior Oral Systemic Corticosteroid Use Initiating Dupilumab in a Real-World Registry (RAPID)

Adverse Cardiovascular Outcomes in Patients with Obstructive Sleep Apnea and Obesity: Metabolic Surgery versus Usual Care.

No therapy has been shown to reduce the risk of major adverse cardiovascular events (MACE) and death in patients with obstructive sleep apnea (OSA). To investigate the long-term relationship between metabolic surgery and incident MACE in patients with OSA and obesity. Adult patients with BMI 35-70 kg/m2 and moderate-to-severe OSA at a US health system (2004-2018) were identified. Baseline characteristics of patients who underwent metabolic surgery were balanced with a nonsurgical control group using overlap weighting methods. Multivariable Cox regression analysis estimated time-to-incident MACE. Follow-up ended in September 2022. 13,657 patients (7496 [54.9%] men; mean age, 52.0 years [SD 12.4]; median BMI, 41.0 [IQR, 37.6-46.2]), including 970 patients in the metabolic surgery group and 12,687 patients in the nonsurgical group, with a median follow-up of 5.3 years (IQR, 3.1-8.4 years) were analyzed. The mean between-group difference in body weight at 10 years was 26.6 kg (95% CI, 25.6-27.6) or 19.3% (95% CI, 18.6%-19.9%). The 10-year cumulative incidence of MACE was 27.0% (95% CI, 21.6%-32.0%) in the metabolic surgery group and 35.6% (95% CI, 33.8%-37.4%) in the nonsurgical group (adjusted HR, 0.58 [95% CI, 0.48-0.71], P < .001). The 10-year cumulative incidence of all-cause mortality was 9.1% (95% CI, 5.7%-12.4%) in the metabolic surgery group and 12.5% (95% CI, 11.2%-13.8%) in the nonsurgical group (adjusted HR, 0.63 [95% CI, 0.45-0.89], P = .009). Among patients with moderate-to-severe OSA and obesity, metabolic surgery, compared with nonsurgical management, was associated with a significantly lower risk of incident MACE and death.

Enfortumab vedotin-related cutaneous toxicity correlates with overall survival in patients with urothelial cancer: a retrospective experience.

Enfortumab vedotin (EV) is an antibody drug conjugate approved for advanced urothelial cancer, consisting of a monomethyl auristatin E payload linked to a human monoclonal antibody targeting nectin-4. No validated biomarker predictive of or correlated with response exists for EV. Cutaneous toxicity is among the most common EV-related toxicities and typically emerges in early cycles. This retrospective experience of patients with urothelial cancer treated with EV monotherapy evaluated whether EV-related cutaneous toxicity correlated with improved outcomes including progression-free (PFS) and overall (OS) survival and overall response rate (ORR). Patients treated with EV monotherapy at Johns Hopkins were identified, and baseline characteristics, treatment, and toxicity details were extracted through chart review. Univariable Cox hazard ratios (HRs) were calculated for assessing the effect of baseline patient characteristics and cutaneous toxicity in PFS and OS. Based on the univariable analysis and known risk factors, all subsequent analyses were adjusted for: Eastern Cooperative Oncology Group performance status, visceral metastases at baseline, gender as well as EV dose, and weight to account for dosing differences. Multivariable Cox proportional HRs were used for comparing PFS and OS between patients with and without cutaneous toxicity, assessing toxicity and EV dose as a time-dependent variables. Adjusted p-values were calculated to compare ORR and disease control rate (DCR) between groups using the Poisson regression model. Of the 78 patients analyzed, 42 (53.8%) experienced EV-related cutaneous toxicity that appeared early during treatment (median time to occurrence 0.5 months from EV initiation). Cutaneous toxicity correlated with significantly improved OS [HR, 0.48; 95% confidence interval (CI), 0.25, 0.9; P = 0.0235], ORR (68.3% vs. 20.7%, P = 0.0033) and DCR (82.9% vs. 48.3%, P = 0.0122). Median PFS was numerically longer in the cutaneous toxicity group (6.3 vs. 1.7 months), although no significance was achieved in the multivariable analysis (HR, 0.62; 95% CI: 0.35, 0.108; P = 0.0925). In this retrospective study, EV-related cutaneous toxicity was associated with improved patient outcomes. Confirming this observation and understanding its mechanism could lead to discovery of a new clinical biomarker of EV response that can emerge in the first cycle.

Developing a Coordinated Registry Network for devices used for acute ischemic stroke intervention: basilar artery occlusion quality assessment pilot

BackgroundReal-world data can be helpful in evaluating endovascular therapy (EVT) in ischemic stroke care. We conducted a pilot study to aggregate data on basilar artery occlusion (BAO) EVT from existing...

Partial nephrectomy after a period of active surveillance: Are perioperative and pathology outcomes worsened compared to immediate surgery?

IntroductionActive surveillance (AS) is a viable strategy for managing small renal masses (SRMs) in lieu of immediate surgery, but concerns persist regarding its impact on delayed partial nephrectomy (PN) outcomes. We aimed to compare perioperative and pathological outcomes of patients initially on AS for SRMs, later undergoing PN, against those undergoing immediate PN. Materials and methodsData were extracted from a prospective institutional database (January 2018–September 2023) for patients with cT1a renal masses. Only malignancies confirmed at final pathology were included. Baseline patient and tumor characteristics and the time from AS enrollment to PN were recorded. Surgical, renal functional, and final pathology outcomes were analyzed, including histology, tumor size, pT stage, upstaging rate, and positive surgical margins. Predictors of upstaging were identified using logistic regression models. ResultsAnalysis included 356 patients: 307 immediate PN and 49 deferred PN after a median of 18 months in AS. Groups had comparable baseline characteristics; no significant differences emerged in surgical and postoperative outcomes. Final pathology revealed no significant disparities in tumor size, histology, positive margins, or upstaging, though pT stage distribution differed (2.4 % versus 4.3 % for pT3a, immediate versus deferred, p = 0.04). Univariable analysis identified RENAL Score (OR 1.29, 95 % C.I. 1.09–1.53, p = 0.003) and clinical tumor size (OR 1.16, 95 % C.I. 1.10–1.22, p < 0.01) as upstaging predictors, confirmed by multivariable analysis (p < 0.01). ConclusionOur comparative analysis found no worsened perioperative or adverse pathological outcomes in patients with deferred PN, supporting the safety of this approach in managing SRMs, at least as an initial option.

Impact of thyroid hormone replacement therapy on the course and functional outcome of aneurysmal subarachnoid hemorrhage

BackgroundThyroid hormones were reported to exert neuroprotective effects after ischemic stroke by reducing the burden of brain injury and promoting post-ischemic brain remodeling.ObjectiveWe aimed to analyze the value of thyroid hormone replacement therapy (THRT) due to pre-existing hypothyroidism on the clinical course and outcome of aneurysmal subarachnoid hemorrhage (SAH).MethodsSAH individuals treated between January 2003 and June 2016 were included. Data on baseline characteristics of patients and SAH, adverse events and functional outcome of SAH were recorded. Study endpoints were cerebral infarction, in-hospital mortality and unfavorable outcome at 6 months. Associations were adjusted for outcome-relevant confounders.Results109 (11%) of 995 individuals had THRT before SAH. Risk of intracranial pressure- or vasospasm-related cerebrovascular events was inversely associated with presence of THRT (p = 0.047). In multivariate analysis, THRT was independently associated with lower risk of cerebral infarction (adjusted odds ratio [aOR] = 0.64, 95% confidence interval [CI] = 0.41–0.99, p = 0.045) and unfavorable outcome (aOR = 0.50, 95% CI = 0.28–0.89, p = 0.018), but not with in-hospital mortality (aOR = 0.69, 95% CI = 0.38–1.26, p = 0.227).ConclusionSAH patients with THRT show lower burden of ischemia-relevant cerebrovascular events and more favorable outcome. Further experimental and clinical studies are required to confirm our results and elaborate the mechanistic background of the effect of THRT on course and outcome of SAH.

The Prevalence of Pretransplant Frailty and Mental Distress in Hematopoietic Cell Transplantation and Association with Clinical Outcomes

Frailty is a phenotype of decreased physiologic reserve associated with increased risk of toxicities and nonrelapse mortality (NRM) in hematopoietic cell transplant (HCT) recipients. The incidence, predictors, and adverse effects of pre-HCT frailty are not well known. We evaluated the association of pre-HCT frailty, defined using Fried's criteria, with age and baseline characteristics in patients ≥18 years undergoing autologous (auto) or allogeneic (allo) HCT for hematological malignancies. Assessments were performed as part of routine pre-HCT evaluations and then retrospectively analyzed. We additionally investigated the association of mental health distress indicators with frailty and the association between frailty and transplant outcomes including NRM and overall survival (OS) plus healthcare utilization. Patients undergoing HCT for hematological malignancies were analyzed (total n = 300; 162 auto, 138 allo). The overall prevalence of frailty was 18%, 21.7% among alloHCT, and 14.8% among autoHCT recipients, with similar distributions of frailty domains. Logistic regression analysis of the overall cohort revealed that older age was associated with an increased risk of frailty (odds ratio [OR] 1.37, 95% confidence interval [CI] [1.02-1.82]; P = 0.04). AlloHCT (OR 2.03, CI [1.07-3.84]; P = .03), and patient health questionnaire-9 (PHQ-9) (health depression) score ≥10 (OR 6.28, CI 1.93-20.43; P < .01) were each independently associated with pre-HCT frailty. In alloHCT patients, older age (OR 1.44, CI [1.00-2.06]; P = .05) was the only significant risk factor for pre-HCT frailty, while for autoHCT patients, only a higher PHQ-9 score was associated with frailty (OR 6.43, CI [1.34-30.82]; P = .02). For the whole cohort OS at 1 year was lower in frail recipients at 83% (95% CI, 70-91%) versus 92% (95% CI, 88-95%) in nonfrail (P = .04); with multivariate analysis showing higher risk of death in the frail group (hazard ratio [HR] 2.31, CI 0.97-5.46; P = .06). In the alloHCT cohort, multivariate analysis showed greater 1-year mortality in frail recipients (HR 2.55, CI [0.99-6.56]; P = .053). In the alloHCT recipients, we observed a 1-year NRM of 20% in frail patients versus 9% in nonfrail, and multivariate analysis showed a marginally higher risk of NRM in the frail group (HR 2.70, CI 0.90-8.10; P = .08). Frailty was not associated with higher risk of relapse in alloHCT or autoHCT recipients. Frail alloHCT patients experienced a longer initial hospital stay following HCT compared to nonfrail recipients (P < .01). We observed a high prevalence of pre-HCT frailty across all age groups, and identify older age is a risk factor for frailty, particularly in alloHCT recipients. Frailty is associated with a greater risk of NRM and lower survival which needs investigation in a larger cohort. Frailty associates with greater HCT complexity suggesting a need for early assessments and targeted interventions for this vulnerable population. Our findings suggest the utility of frailty and mental distress screening along with multidisciplinary interventions in pre-HCT to limit the morbidity of HCT.

Effect of heart failure on mortality and clinical outcomes in patients hospitalized with pancreatic cancer.

e16367 Background: Pancreatic cancer (PC) is the fourth leading cause of cancer-related death globally. The impact of HF on clinical outcomes in hospitalized patients with PC remains unknown. Considering the poor prognosis associated with PC, we aim to compare clinical outcomes in PC patients with or without HF. Methods: The research utilized the National Inpatient Sample (NIS) database, covering data from 2019 and 2020. Through this dataset, patients hospitalized with a primary discharge diagnosis of PC and a concurrent secondary diagnosis of HF were identified and a multivariate regression analysis was applied. Our primary outcome was mortality in patients with comorbid heart failure in patients diagnosed with pancreatic cancer compared to pancreatic cancer alone and our secondary outcomes were the length of hospitalization, associated hospitalization cost, and the risk of clinical complications or outcomes such as major depressive disorder, atrial fibrillation, acute coronary syndrome, etc. Baseline patient characteristics were found to be comparable in either group and data hence was not specifically adjusted in this regard. Results: A total of 74,585 patients were hospitalized with PC, of which 5,755 had a concurrent diagnosis of HF. The mean age of patients with HF was 74.43 years, while those without heart failure was 67.97 years. Primary and secondary outcomes were calculated. HF was not found to be an independent predictor of mortality (OR 1.17, 95% CI 0.90-1.53, p=0.22), and there was no significant difference in the length of stay in the hospital between the two groups of patients (1.09, 95% CI 0.59-1.60, p&lt;0.001). However, patients with heart failure had an increased total cost of hospitalization ($18,045, 95% CI 5,697-30,392, p=0.00) and increased odds of worse clinical outcomes such as major depressive disorder (OR 1.26, 95% CI 1.02-1.55, p=0.03), p&lt;0.001), atrial fibrillation (OR 4.59, 95% CI 3.85-5.47), acute coronary syndrome (OR 9.96, 95% CI 4.31-23.01, p&lt;0.001), acute respiratory failure (OR 2.69, 95% CI 2.08-3.47, pneumonia (OR 1.66, 95% CI 1.17-2.36 p=0.00), septic shock (OR 1.54, 95% CI 1.09-2.17, p=0.01), p&lt;0.001), invasive mechanical ventilation (OR 2.70, 95% CI 1.96-3.72, p&lt;0.001), ICU admission (OR 2.18, 95% CI 1.67-2.85, p&lt;0.001), acute kidney injury (OR 1.84, 95% CI 1.56-2.18, p&lt;0.001), and cardiovascular accident (CVA) (OR 2.74, 95% CI 1.37-5.47, p=0.004). Conclusions: HF is not an independent predictor of mortality or prolonged length in PC patients, but it is associated with increased hospitalization costs and adverse clinical outcomes. Implementing careful and aggressive management strategies for addressing HF is necessary to optimize patient quality of life, minimize adverse events, and reduce resource utilization to minimize the costs of hospitalization and improve quality of life.