Multicenter Registry Of Patients Research Articles

Clinical outcomes of immunomodulation therapy in immunocompromised patients with severe Covid-19 and high oxygen requirement

Covid-19 disease is implicated in increased mortality among immunocompromised patients. The JAK inhibitor, baricitinib (bar), or the IL-6 inhibitor, tocilizumab (toc), demonstrated a survival benefit in patients with severe disease.However, evidence supporting their use in immunocompromised patients with severe Covid-19 is scarce.We aimed to assess clinical outcomes of bar/toc treatment in immunocompromised patients. A multi-center registry of consecutive immunocompromised patients hospitalized due to severe Covid-19 during the Omicron variant dominance period. After excluding patients who did not require high oxygen supply, patients treated with bar/toc were compared to patients treated by standard of care (SOC). Primary outcome was in hospital mortality. Secondary outcomes were 30 and 60 day mortality, super-infection and thromboembolic events. Among an overall 228 immunocompromised patients hospitalized in six Israeli hospitals with severe Covid-19, 112 patients required high oxygen support, of whom 48 (43%) were treated with bar/toc. In-hospital mortality rates were exceptionally high and did not significantly differ between bar/toc and SOC treated patients (62.5% vs. 64.1%, p = 1.0). A logistic regression analysis revealed that advanced age and incomplete vaccination were predictors of in-hospital mortality. Patients treated with bar/toc had no excess of suspected super-infection (62.8% vs. 60.7%, p = 0.84) or thromboembolic events (8.3% vs 3.1%, p = 0.39). In immunocompromised patients with severe Covid-19 and a high oxygen demand, bar/toc therapy was not associated with reduced mortality or with a higher rate of associated complications, compared to SOC. Larger prospective studies should better address efficacy and safety.

Assessment of automated TICI scoring during endovascular treatment in patients with an ischemic stroke

BackgroundThe extended Thrombolysis in Cerebral Infarction (eTICI) score is used in digital subtraction angiography (DSA) to quantify reperfusion grade in patients with an ischemic stroke who undergo endovascular thrombectomy (EVT)....

Long-Term Survival Of Subcutaneous Biosimilar TNFα Inhibitors Compared To Originators: Results From A Multicenter Prospective Registry.

To analyze the long-term survival of subcutaneous biosimilar TNFα-inhibitors (TNFi) compared to the originator molecules in patients with rheumatic diseases, and the factors associated with drug discontinuation. Retrospective analysis of BIOBADASER, the Spanish multicenter prospective registry of rheumatic patients on biological and targeted disease-modifying anti-rheumatic drugs. Patients who started etanercept or adalimumab from January 2016 to October 2023 were included. The survival probabilities of biosimilars and originators were compared using Kaplan-Meier estimating curves. To identify factors associated with differences in the retention rates, hazard ratios (HR) were estimated using Cox regression models for all and specific (inefficacy or adverse events) causes of discontinuation. A total of 4162 patients received 4723 treatment courses (2991 courses of adalimumab and 1732 courses of etanercept), of which 722 (15.29%) were originator molecules and 4001 (84.71%) biosimilars. The originators were more frequently discontinued than biosimilars (53.32% and 33.37%, respectively). The main reason for discontinuation was inefficacy (60.35% of the treatments). The risk of overall discontinuation was lower for biosimilars (adjusted HR 0.84, 95% CI: 0.75-0.95). Female sex, obesity and second or later treatment lines increased the risk of discontinuation, while disease duration and the use of concomitant methotrexate were associated to a greater survival. When assessing cause-specific reasons of discontinuation, excluding nonmedical switching, the results from the crude and adjusted analyses showed no significant differences in the retention rate between biosimilars and originators. No significant differences were found between treatmens in the longterm survival due to inefficacy or adverse events.

Bicuspid valve CT registry of balloon-expandable TAVR: BETTER TAVR registry.

The anatomic substrate of bicuspid valves may lead to suboptimal TAVR stent expansion and geometry. We evaluated determinants of stent geometry in bicuspid valves treated with Sapien transcatheter aortic valve replacement (TAVR) valves. A multicenter retrospective registry of patients (February 2019 to August 2022) who underwent post-TAVR computed tomography to determine stent area (vs. nominal valve area) and stent ellipticity (maximum diameter/minimum diameter). Predictors of relative stent expansion (minimum area/average of inflow + outflow area) and stent ellipticity were evaluated in a multivariable regression model, including valve calcium volume (indexed by annular area), presence of raphe calcium, sinus diameters indexed by area-derived annular diameter, and performance of pre-dilation and post-dilation. The registry enrolled 101 patients from four centers. The minimum stent area (vs. nominal area) was 88.1%, and the maximum ellipticity was 1.10, with both observed near the midframe of the valve in all cases. Relative stent expansion ≥90% was observed in 64/101 patients. The only significant predictor of relative stent expansion ≥90% was the performance of post-dilation (OR: 4.79, p = 0.018). Relative stent expansion ≥90% was seen in 86% of patients with post-dilation compared to 57% without (p < 0.001). The stent ellipticity ≥1.1 was observed in 47/101 patients. The significant predictors of stent ellipticity ≥1.1 were the indexed maximum sinus diameter (OR: 0.582, p = 0.021) and indexed intercommisural diameter at 4 mm (OR: 2.42, p = 0.001). Stent expansion has a weak negative correlation with post-TAVR mean gradient (r = -0.324, p < 0.001). Relative stent expansion ≥90% was associated with the performance of post-dilation, and stent ellipticity ≥1.1 was associated with indexed intercommisural diameter and indexed maximum sinus diameter. Further studies to determine optimal deployment strategies in bicuspid valves are needed.

First-time catheter ablation outcomes for atrial fibrillation are dependent on low-voltage areas rather than paroxysmal vs. persistent classifications: a REAL-AF study

Abstract Background Left atrial low-voltage areas (LA LVA) measured at time of catheter ablation for atrial fibrillation (AF) have been increasingly recognized as an indicator of atrial fibrosis [1]. However, little is known whether first-time catheter ablation outcomes differ between paroxysmal AF (PAF) and persistent AF (PerAF) in patients with higher LA LVA, which may indicate a more advanced substrate independent of clinical subtype. Purpose To evaluate whether outcomes of first-time catheter ablation for AF are dependent on LA LVA rather than PAF vs. PerAF types in a multicenter registry of patients. Methods The Real-world Experience of Catheter Ablation for the Treatment of Symptomatic PAF and PerAF Using Novel Contact Force Technologies registry (REAL-AF) is a prospective, observational multicenter registry of patients undergoing catheter ablation. We evaluated 4181 patients undergoing first-time catheter ablation for both PAF and PerAF to determine AF recurrence within 12 months. Contact maps were created using a 5-spline high-density catheter. LA LVA was calculated using these contact maps based on a bipolar voltage of &amp;lt;0.50 mV. LA LVA was categorized into low (&amp;lt;5%) vs. high (≥5%) based on preliminary data. Risk of recurrence was analyzed using Cox proportional hazard models. Results Patients with LA LVA ≥5% who underwent first-time catheter ablation for AF (both PAF and PerAF) experienced a higher risk of AF recurrence within 12 months (Hazard ratio (HR): 1.95, p&amp;lt;0.001), see Figure 1. Overall, 82.0% of patients were free of AF in the LA LVA &amp;lt;5% group compared to 69.1% in the LA LVA ≥5% group. This association remained significant in a subpopulation of patients presenting in normal sinus rhythm (N = 2463) at time of ablation (HR: 1.90, p&amp;lt;0.001). 12-month ablation outcomes between PAF and PerAF in patients with LA LVA ≥5% (N = 1590) were not statistically significant (71.0% vs 67.3% respectively, HR: 1.15, p=0.30), see Figure 2. Finally, in the LA LVA &amp;lt;5% group (N = 2591), patients with PerAF had a 1.42 times higher risk for AF recurrence within 12 months after catheter ablation (p=0.04). Conclusion This is the largest real-world registry to date demonstrating that LA LVA ≥5% is associated with a higher risk of AF recurrence within 12 months in patients undergoing first-time catheter ablation for AF. Among patients with LA LVA ≥5%, AF recurrence was not associated with AF type. These findings motivate further studies into using LA LVA as a prognostic tool for patients undergoing first-time catheter ablation for AF and using non-invasive methods to assess this in order to stratify patients further.

Associations between stroke risk factors and left atrial low-voltage areas in patients with atrial fibrillation undergoing catheter ablation from the REAL-AF registry

Abstract Background Prior research indicates that increased left atrial low-voltage areas (LA LVA) are linked to comorbidities and CHA2DS2-VASc score in patients with persistent atrial fibrillation (PerAF) undergoing catheter ablation. However, given the heterogeneity of AF where patients may transition between paroxysmal AF (PAF) and PerAF types, it is biologically plausible that these associations span all forms of AF. Purpose To investigate the relationship of stroke demographics and comorbidities to LA LVA and AF type in a multicenter registry of patients undergoing catheter ablation. Methods The Real-world Experience of Catheter Ablation for the Treatment of Symptomatic PAF and PerAF Using Novel Contact Force Technologies registry (REAL-AF) is a prospective, observational multicenter registry of patients undergoing catheter ablation. We evaluated 6053 patients undergoing first-time catheter ablation for both PAF and PerAF to identify associations between stroke risk factors and LA LVA. LA LVA was determined in contact maps as bipolar voltage &amp;lt;0.50 mV. Mapping was completed using 5-spline high-density catheters before ablation. LA LVA was categorized into low (&amp;lt;5%) vs. high (≥5%) based on preliminary data. Analyses were conducted using independent samples t-test and Chi-square test. Results LA LVA was associated with greater CHA2DS2-VASc score (3.2 vs. 2.5, p &amp;lt;0.001). Age 75+ (Odds ratio (OR): 2.22, p&amp;lt;0.001), congestive heart failure (CHF) (OR: 2.01, p&amp;lt;0.001), female sex (OR): 1.51, p&amp;lt;0.001), vascular disease (OR: 1.50, p&amp;lt;0.001), age 65-74 (OR: 1.20, p=0.001), hypertension (OR: 1.38, p&amp;lt;0.001), history of stroke (OR: 1.29, p=0.004) and diabetes (OR: 1.25, p=0.001) were also associated with LA LVA (Table 1). These associations remained significant among a subgroup of those presenting in normal sinus rhythm (N = 3546). Patients with CHF (OR: 2.09, p&amp;lt;0.001), hypertension (OR: 1.89, p&amp;lt;0.001) and male sex (OR: 0.60, p&amp;lt;0.001) were more likely to have PerAF in the LVA ≥5% subgroup (n=1594) (Table 2). All other components of the CHA2DS2-VASc score were not significantly associated with AF type in this subgroup. While there was a significant association between AF type and CHA2DS2-VASc score (PAF: 3.15, PerAF: 3.42, p&amp;lt;0.001) in the LA LVA ≥5% subgroup, the effect size was small (Cohen’s d = -0.179). Conclusion LA LVA ≥5% was associated with all separate components and overall CHA2DS2-VASc score. In patients with LA LVA ≥5%, there were only associations between PerAF and CHF, hypertension, and male sex, implying a special role in substrate progression. Our findings suggest that LA LVA may represent a more sensitive clinical phenotyping tool of AF rather than current duration-based ones. This is the largest study to our knowledge in elucidating the relationship between increased LA LVA and stroke risk factors in the AF population.

#2278 EUROCYS, a European cystinuria registry

Abstract Background and Aims Cystinuria (OMIM 220100) is a rare autosomal recessive disorder in which high urinary cystine excretion leads to formation of cystine stones due to its low solubility at normal urinary pH. Retrospective series have been published but precise data to guide long term optimal management of these patients are lacking. Our goal was to collect consistent and comparative prospective clinical, biological, genetic and radiological data from patients (children and adults) with cystinuria followed in European centers. Method We developed EUROCYS, a multidisciplinary, European, multicenter registry of patients with cystinuria in which demographic, clinical, surgical, biological, genetic, radiological and therapeutic data are collected longitudinally. These data are recorded via the European Rare Kidney Disease Registry (ERKReg) platform. Results Enrolment started in July 2021. To date, 269 patients have been included at 29 different centers in 8 European countries. Mean age at diagnosis was 18.7 years (SD 17.3) and mean age at inclusion was 35.4 years (20.2). 86.9% of patients had less than 9 calculi extractions reported, 11.0% had between 10 to 19, and 2.0% had more than 20. 61.4% (418/680) were treated by ureteroscopy, 16.2% (110/680) by shock wave lithotripsy and 16.0% (109/680) by percutaneous nephrolithotomy. 39% of patients had a new stone expulsion or surgery during the last 12 months. At the inclusion visit, mean urinary pH was below the recommended level at 6, 8 (0.8). Only 16.3% of patients had a urinary pH between 7.5 and 8: 77.2% of patients had a urinary pH below 7.5 and 6.3% above 8. In adults, mean 24-hour urinary volume was 2653 mL (1077). 34.9% had a target urine volume above 3000 ml. Under treatment, spot urine cystine concentration was 345.5 mg/l (255.2) and 44.8% of patients had a concentration below target concentration (250 mg/l). Mean sodium urinary excretion was 147 mmol/24 h (67). Only 29% of patients had a sodium urinary excretion below 100 mmol/24 h. As alkalinizing agent, 87.2% of patients received potassium citrate, 16.3% sodium bicarbonate and 9.1% potassium bicarbonate. As cystine binding drug, 71 patients (26.7%) were treated with Tiopronin and 3 experienced serious adverse events (hematological, cutaneous, proteinuria). 15 (5.6%) were treated with D-Penicillamine and 2 had adverse events (proteinuria and gastrointestinal). In adults, mean eGFR at inclusion was 82.1 ml/min/1.73 m² (26.3): 40.9% of patients were at chronic kidney disease (CKD) stage 1, 40.1% at CKD2, 16.7% at CKD3, 0.7% at CKD 4 and 1.5% at CKD5. Conclusion The EUROCYS registry shows real life data on cystinuria patients followed in European centers. Despite alkalinizing treatment, most patients do not reach the recommended urinary pH level and only one third have an adequate urinary volume. This registry will allow analyzing the impact of adhesion to recommendations on disease activity.

Trends in primary percutaneous coronary intervention for the treatment of acute coronary ST-elevation myocardial infarction in Latin American countries: insights from the CECI consortium.

ST-elevation myocardial infarction (STEMI) requires revascularization treatment, preferably via primary percutaneous coronary interventions (pPCI). There is a lack of data about contemporary management of STEMI in Latin America. This was a multicenter, multinational, prospective, and dynamic registry of patients undergoing pPCI in Latin America for STEMI (STEMI/LATAMI Registry) that was carried out in nine centers from five countries (Argentina, Ecuador, Venezuela, Bolivia, and the Dominican Republic) between June 2021 and June 2023. All interventionalists involved in the study were originally trained at the same institution (Centro de Estudios en Cardiología Intervencionista, Buenos Aires, Argentina). The primary objective was to evaluate procedural and in-hospital outcomes of pPCI in STEMI and in-hospital outcome in the Latin America (LATAM) region; as secondary endpoints, we analyzed the following subgroups: differences between pPCI vs. pharmaco-invasive or late presenters, gender, elderly and very elderly patients, cardiogenic shock outcomes, and causes of STEMI. In total, 744 STEMI patients who underwent PCI between June 2021 and June 2023 in five countries (nine centers) in our continent were included; 76.3% had a pPCI, 8.1% pharmaco-invasive PCI, and 15.6% had late STEMI PCI. There were no differences in region or center when we evaluated in-hospital and 30 days of death. The rate of procedural success was 96.2%, and the overall in-hospital mortality rate was 2.2%. In the subgroup of pPCI, mean symptom onset-to-balloon time was 295.3 ± 246 min, and mean door-to-balloon time was 55.8 ± 49.9 min. The femoral approach was chosen in 60.5%. In 3.0% of patients, the left main disease was the culprit artery, with 1.63 ± 1.00 stents per patient (564 drug-eluting stents and 652 bare metal stents), with 34 patients receiving only plain optimal balloon angioplasty. Definitive stent thrombosis was related to the infarct artery as the primary cause of STEMI in 7.5% of patients. The use of assistant mechanical devices was low, at 2.1% in the pPCI group. Women were older, with large numbers in very elderly age (≥90 years), greater mortality, and incidence of spontaneous coronary dissection as a cause of STEMI (p < 0.001, p < 0.001, p < 0.001, and p < 0.003, respectively). In suitable LATAM Centers from low/medium-income countries, this prospective registry in patients with STEMI, PCI performed by well-trained operators has comparable results to those reported in well-developed countries.

Clinical impact of a cardiac intensivist in an adult cardiac care unit from the RESCUE registry

Abstract Funding Acknowledgements None. Purpose Dedicated intensive care unit (ICU) physician staffing is assocated with a reduction in ICU mortality rates in general medical and surgical ICUs. However, limited data area available on the role of cardiac intensivist in the cardiac intensive care unit (CICU). We investigated the association of cardiac intensivist-directed care with clinical outcomes in adult patients admitted to the CICU. Methods The SMART-RESCUE study is a multicenter, retrospective and prosective registry of patients that presented witth cardiogenic shock (CS). Between January 2014 and December 2018, 1,247 patients with CS were enrolled from 12 major centers in Korea. The study population was divided into 2 groups, according to the presence of a cardiac intensivist. The primary outcome was in-hospital mortality. Results THe analysis with SMART-RESCUE registry included 1,247 patients with CS (n=552 in the group with cardiac intensivist and n=695 in the group without cardiac intensivist) (Table 1). The in-hospital survival rate was significant higher in the group with intensivist than that in the group without intensivist (72.1% vs 59.2%, p &amp;lt; 0.001) (Figure 1). Cardiac intensive care with cardiac intensivist was associated with a reduction in risk-adjusted in-hospital mortality (adjusted odds ratio for in hospital death, 0.53; 95% confidence interval: 0.401 to 0.704; p &amp;lt; 0.001). Survival analysis also revealed significantly higher death free survival in te group with intensitivst. In multivariable analysis, cardiac intensivist, chronic kidney disease, ECMO-cardiopulmonary resuscitation, ST elevation myocardial infarction presentation and vasotrope-inotrope score were selected to be significant prognostic predictors for death in the CICU. Concluison: The presence of a dedicated cardiac intensivist was associated with a reduction in hospital mortality rates in patients with cardiovascular disease who required critical care.

Risk of sepsis after extracorporeal cardiopulmonary resuscitation in patients with refractory cardiogenic shock from the RESCUE registry

Abstract Funding Acknowledgements None. Objectives It is known that the incidence of sepsis is higher in patients receiving extracorporeal membranous oxygenation (ECMO). In particular, extracorporeal cardiopulmonary resuscitation (ECPR) is performed in emergency situations, which may increase the likelihood of non-aseptic management compared to routine procedures. So, we investigated the association of ECPR and incidence of sepsis in patients with refractory cardiogenic shock (CS). Background Pre- and post-ECPR sepsis are associated with increased mortality, and it is known that the occurrence of sepsis after ECPR is higher than in conventional cardiopulmonary resuscitation (CPR). However, it is not well known whether ECPR has a higher incidence of sepsis than ECMO insertion in non-CPR conditions. Method The SMART-RESCUE study is a multi-center, retrospective and prospective registry of patients that presented with CS. Between January 2014 and December 2018, 1,247 patients with CS were enrolled from 12 major centers in Korea. The incidence of sepsis was compared by dividing into two groups according to whether or not ECPR was performed. Patients with ECMO duration less than 48 hours were excluded. Result Total of 231 patients(mean age 59.46 years, men 67.70%, mead follow-up duration 136.5 days) were analyzed into ECPR group(n=95, 60.7 ± 13.0 years, men 75.8%) and non-ECPR group(n=136, 58.6 ± 15.5 years, men 65.4%) respectively. ECPR group showed lower SBP, lower DBP, lower HR, more shock caused by ischemia, more smoking, lower LVEF, higher Hb, higher serum Na, lower AST, higher Peak troponin I, higher vasoactive inotropic score, higher ICMP portion. After 1:1 propensity score matching corrected for height, SBP, DBP, Hb, initial pump flow, Na, ICMP, vasoactive inotropic score, difference remained in SBP, DBP, HR, cause of shock. Sepsis incidence was 7.4%. The risk for sepsis incidence was not different between two groups(7.4% vs 6.3%, adjusted OR 1.18, 95% CI 0.38-3.65, p=0.774). Conclusion ECPR procedure does not increase sepsis compared to ECMO insertion not in CPR state in patients with cardiogenic shock. Keyword: Extracorporeal membrane oxygenation, cardiopulmonary resuscitation, sepsis, cardiogenic shockBaseline characteristicsAdjusted outcomes

De-escalating treatments and transitioning care in a cardiac intensive care units network

Abstract Funding Acknowledgements None. Background Recent data (1) have shown that end-of-life (EOL) management of patients with acute decompensated heart failure (ADHF) in Cardiac Intensive Care Units (CICU) is aggressive, with late or no involvement of palliative care (PC) teams. Purpose To evaluate current PC and EOL practices in a contemporary multicenter registry of patients with ADHF who deteriorated to cardiogenic shock (CS). Methods A survey-based approach was used to collect data on PC and EOL management practices. We enrolled CS patients from 12 participating centers. A subset of 153 patients with ADHF-CS, enrolled between March 2020 and March 2023, was analyzed. We asked participating centers to report their practice regarding de-escalating treatments and transitioning care in the context of EOL, focusing on 1) discussion of implantable cardioverter defibrillator (ICD) deactivation with patients, 2) documentation of do-not-resuscitate (DNR) orders in the patient's medical record, and 3) documentation of advance directives in the patient's medical record. We also examined early PC team involvement and ICD deactivation as indicators of de-escalating treatments and transitional care in ADHF-CS. Results are presented as numbers and percentages (%) for categorical variables and medians (interquartile range, IQR) for continuous variables. Results Baseline characteristics of the population are shown in Table 1. Figure 1 describes the practices of the participating centers. DNR was routinely documented in the medical records in only 5 of 12 centers (41.7%). PC teams were involved in 21 of 153 enrolled ADHF-CS patients (13.7%). Of the 51 patients with an ICD, 17 died: 13 patients (76%) died in the hospital and 4 (24%) died within 6 months of discharge. ICD deactivation occurred in 6 of 17 deceased patients (35.3%). One patient had ICD deactivation supported by home PC services. Conclusions This study shows that the practice of de-escalating therapy, including ICD deactivation, is not routine in the participating centers. Our findings highlight the importance of integrating PC as a concurrent process with intensive care to effectively address the unmet needs of these patients and their families.

Abstract PO4-04-14: Change of first-line treatment pattern in metastatic luminal breast cancer: Results from the Austrian AGMT_MBC-Registry

Abstract Background: For patients with HR+/HER2- (luminal) metastatic breast cancer (MBC), international guidelines recommend endocrine-based first-line therapy [ET] in combination with a CDK4/6 inhibitor for most patients. Only for patients with imminent organ failure, first-line chemotherapy should be considered. To clarify changing patterns of first-line treatments over time in an Austrian population of luminal MBC patients, we analyzed the data from the MBC registry of the Austrian Study Group for Medical Tumor Therapy (AGMT-MBC-Registry). Methods: The AGMT-MBC-Registry is an ongoing multicenter registry for MBC patients in Austria. Only patients with luminal MBC and sufficient outcome data were included in this analysis. Patients were assigned to one of the following groups according to the year of start of first-line treatment for MBC: 2001-2010, 2011-2013 (no CDK4/6i available for first-line in both periods), 2014-2016 (CDK4/6i available in early access programs and clinical trials for first-line only), 2017-2019, and 2020-2022 (CDK4/6i available in both periods). Time to first chemotherapy (TTC) defined as start of first-line treatment until first application of a cytotoxic agent, and overall survival (OS) defined as start of first-line treatment until death were calculated by the Kaplan-Meier method and compared using the log-rank test. OS analysis was adjusted for disease free survival (DFS) category (de novo, DFS &amp;lt; 24 month, DFS ≥ 24 month), menopausal status (pre-, postmenopausal, unknown), age at diagnosis of metastatic disease (continuous), number of metastatic sites at diagnosis (1, 2-3, &amp;gt; 3), visceral disease (no, yes), and Charlson comorbidity index at diagnosis (continuous). Results: As of May 16th 2023, 1,330 patients with HR+/HER2- disease receiving at least one treatment-line for MBC were evaluable. First-line treatments significantly changed over time (P &amp;lt; 0.001). In patients diagnosed between 2001 and 2010, 61.4% were treated with first-line chemotherapy compared to 10.0% in patients diagnosed between 2020 and 2022 (Table 1). Additionally, TTC also significantly increased over time (P &amp;lt; 0.001; Table 2). In contrast, the proportion of patients treated with a first-line CDK4/6i plus endocrine therapy combination increased over time from 4.4% in 2014-2016 up to 75.5% in the period of 2020-2022. Additionally, adjusted median overall survival estimates significantly increased over time (P &amp;lt; 0.001; Table 2). Conclusion: In our registry, the proportion of patients with luminal MBC treated with first-line chemotherapy significantly decreased over time, whereas the proportion or patients treated with first-line CDK4-6 inhibitors significantly increased. This is in line with the change of guideline recommendation as well as the availability of CDK4-6 inhibitors over the last 2 decades. The availability of new treatment options has significantly increased median overall survival over time. Table 1: First-line treatment pattern over time Period N ET ET plus CDK4/6i Chemotherapy Others* 2001-2010 220 84 (38.2%) 0 (0.0%) 135 (61.4%) 1 (0.5%) 2011-2013 238 116 (48.7%) 0 (0.0%) 110 (46.2%) 12 (5.0%) 2014-2016 318 174 (54.7%) 14 (4.4%) 99 (31.1%) 31 (9.7%) 2017-2019 293 60 (20.5%) 190 (64.8%) 36 (12.3%) 7 (2.4%) 2020-2022 249 22 (8.8%) 188 (75.5%) 25 (10.0%) 14 (5.6%) Overall 1,318 456 (34.6%) 392 (29.7%) 405 (30.7%) 65 (4.9%) Legend: N - number of patients, ET - endocrine therapy (tamoxifen, aromatase inhibitor and/or fulvestrant), CDK4/6i - CDK4/6 inhibitor; * e.g. endocrine treatment plus everolimus or investigational study treatment Table 2: Time to first chemotherapy (TCC) and overall survial (OS) over time Period Median TTC [months] Adjusted median OS [months] 2001-2010 0.0 (0.0 - 0.0) 49.4 (41.2 - 56.6) 2011-2013 4.3 (0.0 - 13.8) 48.2 (38.3 – 69.7) 2014-2016 20.0 (14.0 - 26.4) 60.3 (50.2 - 77.5) 2017-2019 40.1 (33.3 - 59.8) 60.8 (52.8 - NR) 2020-now 30.4 (27.6 - NR) NR (NR - NR) Legend: N - number of patients, NR - not reached Citation Format: Gabriel Rinnerthaler, Simon Gampenrieder, Angelika Pichler, Walter Herz, Andreas Petzer, Renate Pusch, Marija Balic, Christoph Suppan, Sonja Heibl, Lukas Scagnetti, Margit Sandholzer, Clemens Schmitt, August Zabernigg, Daniel Egle, Petra Pichler, Christopher Hager, Florian Roitner, Johannes Andel, Kathrin Strasser-Weippl, Rupert Bartsch, Michael Hubalek, Michael Knauer, Christian F. Singer, Richard Greil. Change of first-line treatment pattern in metastatic luminal breast cancer: Results from the Austrian AGMT_MBC-Registry [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-04-14.

Abstract PO1-05-13: Drop-out rates from line to line of treatment in metastatic breast cancer (MBC): Results from the Austrian AGMT_MBC-Registry

Abstract Background: In metastatic breast cancer (MBC) continuous treatment with sequentially administered cancer drugs is the standard of care. Lines of treatment (LoT) consisting of single drugs or drug combinations are usually administered until disease progression or unacceptable toxicity. To provide as many patients as possible access to the most effective therapies, the “best treatment first” strategy has been established as a subset of patients will be lost from LoT to LoT. To investigate drop-out rates in all subsequent LoT, high-quality real-world data are needed. Here, we present data from the Austrian Study Group of Medical Tumor Therapy (AGMT) MBC-Registry, a multicenter nationwide ongoing retrospective and prospective registry for MBC patients in Austria. Patients and methods: Patients with known hormone-receptor (HR) and HER2 status, available survival data and at least one LoT were included. Therapies administered between diagnosis or disease progression and subsequent disease progression were counted as one LoT. All types of antitumor drugs (endocrine therapy, targeted therapy, chemotherapy, immunotherapy) were considered. Results: As of 16-May-2023, 2,484 patients were included in the registry. Out of 2,044 evaluable patients, 1,330 (65.1%) were HR+/HER2-, 251 (12.3%) were HR+/HER2+, 146 (7.1%) were HR-/HER2+ and 317 (15.5%) were triple-negative, respectively. The median number of treatment-lines in the overall cohort was 3 (range 1-14; 95%CI 3-3). In patients with HR+/HER2-, HR+/HER2+, HR-/HER2+ and triple-negative tumors the median LoT were 3 (range 1-14; 95%CI 3-4), 4 (range 1-13; 95%CI 3-4), 3 (range 1-10; 95%CI 3-4) and 2 (range 1-9; 95%CI 2-3), respectively. Overall, 641 patients were still on treatment at data cut off. The estimated percentage of patients being treated in each LoT and the corresponding drop-out rates from 1st- to 5th-line are provided in Table 1. Conclusion: Relevant drop-out rates even in the early treatment lines support a “best treatment first” strategy. An accelerated investigation of promising cancer drugs in early treatment lines in patients with MBC is warranted. Drop-out-Rate 1st-line 2nd-line 3rd-line 4th-line 5th-line All n 2044 1281 869 558 344 Drop-out-Rate / 23.8% 24.8% 30.9% 34.0% HR+/HER2- n 1,330 854 586 380 244 Drop-out-Rate / 19.6% 23.0% 29.6% 30.7% HR+/HER2+ n 251 157 109 72 48 Drop-out-Rate / 23.4% 20.4% 25.0% 28.4% HR-/HER2+ n 146 78 59 37 24 Drop-out-Rate / 36.6% 16.9% 36.2% 33.3% Triple-negative n 317 192 115 69 28 Drop-out-Rate / 34.0% 38.2% 39.5% 57.6% Citation Format: Simon Gampenrieder, Gabriel Rinnerthaler, Angelika Pichler, Walter Herz, Andreas Petzer, Clemens Dormann, Marija Balic, Christoph Suppan, Sonja Heibl, Lukas Scagnetti, Margit Sandholzer, Clemens Schmitt, August Zabernigg, Daniel Egle, Petra Pichler, Christopher Hager, Florian Roitner, Johannes Andel, Kathrin Strasser-Weippl, Rupert Bartsch, Michael Hubalek, Michael Knauer, Christian F. Singer, Richard Greil. Drop-out rates from line to line of treatment in metastatic breast cancer (MBC): Results from the Austrian AGMT_MBC-Registry [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-05-13.

Real-world Outcomes from a Prospective, Multicenter Deep Brain Stimulation Registry of Essential Tremor Patients (P3-3.004)

Real-world Outcomes from a Prospective, Multicenter Deep Brain Stimulation Registry of Essential Tremor Patients (P3-3.004)

Rationale and Design of the Latin-American Registry of Peripheral Interventions: Insights From SOLACI Peripheral

BackgroundChronic limb-threatening ischemia (CLTI) represents the most advanced stage of lower extremity peripheral artery disease (PAD). The aim of this manuscript is to provide an overview of the demographic and clinical characteristics of patients with lower-limb peripheral artery disease, as well as the procedural and technical aspects of peripheral endovascular interventions in Latin-America. MethodsThe SOLACI peripheral registry is a prospective, multi-center, observational, and hospital-based registry of patients with lower-limb PAD, who are treated with endovascular interventions across Latin American countries. ResultsA total of 1057 independent procedures (997 patients) were analyzed in this report. The most common clinical presentation was CLTI (61.2%): Advanced stage of the disease was common, and the symptomatic classification was predominately Rutherford V (minor tissue loss) in 37.6%. Index endovascular procedures mainly treated femoral-popliteal and infrapopliteal regions. Disease extending across multiple vascular territories was common and 27.6% of patients underwent angioplasty of multiple regions during the same procedure. There was a high prevalence of cardiovascular risk factors and concomitant comorbidities: hypertension (84.5%), dyslipidemia 67.4%), diabetes mellitus (64.7%), myocardial infarction (17%) and stroke (8.4%). Major adverse events during hospitalization included death from any cause (1.3%), cardiovascular death (0.7 %), myocardial infarction (0.4%), stroke (0.1%) and bleeding (0.8%). ConclusionsReal-world data on lower limb-PAD in Latin American countries will help us identify unmet needs and generate evidence-based recommendations to facilitate the development of more effective preventive and treatment strategies according to each country’s necessities and resources.

Early neurological changes following endovascular therapy for acute stroke due to intracranial atherosclerotic disease

BackgroundEndovascular therapy (EVT) reduces functional disability in patients with acute large vessel occlusion (LVO). However, the early neurological change after EVT may be limited in patients with intracranial atherosclerotic disease (ICAD). MethodsWe analyzed the Japanese Registry of NeuroEndovascular Therapy (JR-NET) 4 which was a retrospective, nationwide, multicenter registry of patients with LVO between 2015 and 2019. We compared the early neurological change, efficacy and safety of EVT for acute LVO in ICAD and other etiologies. The primary outcome was NIHSS improvement ≥10 points, and secondary outcome were NIHSS worsening ≥4 points 7 days after EVT, effective reperfusion rate, 30-day functional outcomes, and safety outcomes. ResultsAmong the 6710 enrolled patients, 610 (9.1%) had ICAD. The ICAD group was younger (mean 72.0 vs. 75.8 years) and predominantly male (63.4% vs. 56.0%), had lower NIHSS scores before EVT (median 16 vs. 18), and underwent percutaneous transluminal angioplasty and stenting more frequently (43.0% vs. 4.4%, 12.3% vs. 4.4%). In the ICAD group, NIHSS improvement was significantly lower (adjusted odds ratio (aOR) [95% confidence interval (95%CI)] 0.52 [0.41–0.65]), NIHSS worsening was significantly higher (aOR [95%CI] 1.76 [1.31–2.34]), and effective reperfusion was significantly lower (aOR [95%CI] 0.47 [0.36–0.60]). Fewer patients with ICAD had modified Rankin scale 0–2 at 30 days (aOR [95%CI] 0.60 [0.47–0.77]). The risk of acute reocclusion was more prominent in the ICAD group (aOR [95%CI] 4.03 [1.98–8.21]). ConclusionsImprovement in neurological severity after EVT was lower in patients with LVO and ICAD.

Description of a national, multi-center registry of patients with sickle cell disease and SARS-CoV-2 infection: Data from the Pediatric COVID-19 United States Registry.

Children with sickle cell disease (SCD) are at risk of complications from viral infections, including SARS-CoV-2. We present the clinical characteristics and outcomes of pediatric patients with SCD from the Pediatric COVID-19 United States Registry who developed acute COVID-19 due to SARS-CoV-2 infection (n=259) or multisystem inflammatory syndrome in children (MIS-C; n=4). Nearly half of hospitalized children with SCD and SARS-CoV-2 infection required supplemental oxygen, though children with SCD had fewer intensive care (ICU) admissions compared to the general pediatric and immunocompromised populations. All registry patients with both SCD and MIS-C required ICU admission. Children with SCD are at risk of severe disease with SARS-CoV-2 infection, highlighting the importance of vaccination in this vulnerable population.

Feasibility and Utility of Anatomical and Physiological Evaluation of Coronary Disease With Cardiac CT in Severe Aortic Stenosis (FUTURE-AS Registry): Rationale and Design

BackgroundCoronary artery disease (CAD) in patients with severe aortic stenosis (AS) is common and may be associated with worse outcomes. Computed tomography coronary angiography (CTCA) and fractional flow reserve derived from computed tomography (FFRCT) are tools for comprehensive coronary assessment. The utility and safety of CTCA and FFRCT in the work-up for transcatheter aortic valve replacement (TAVR) is not established, especially in an evolving landscape that involves younger TAVR patients. The FUTURE-AS Registry will assess the utility and safety of cardiac-optimized CTCA and FFRCT to evaluate CAD and guide referral for downstream invasive coronary angiography (ICA) in patients with severe AS being considered for TAVR. MethodsFUTURE-AS is an international, prospective, multicenter registry of patients with severe AS referred for TAVR being assessed for CAD with CTCA and FFRCT. The primary end point is the per-patient sensitivity and negative predictive value of CTCA and FFRCT for identifying anatomical and physiologically significant CAD compared to ICA and invasive FFR. The safety end point is the incidence of symptomatic hypotension or bradycardia requiring intervention following the administration of nitroglycerin or β-blocker medications. Feasibility end points include the incidence of noninterpretable CTCA scans and CTCA scans not adequate for FFR analysis. Other utility end points include specificity, positive predictive value, and accuracy of CTCA and FFRCT. Lastly, the potential of a CTCA and FFRCT guided strategy to defer pre-TAVR ICA will be assessed. ConclusionsFUTURE-AS will characterize the utility, safety, and feasibility of CTCA and FFRCT for coronary assessment pre-TAVR.

Risk factors of emergency department visits following elective cervical and lumbar surgical procedures: a multi-institution analysis from the Michigan Spine Surgery Improvement Collaborative.

Emergency department visits 90 days after elective spinal surgery are relatively common, with rates ranging from 9% to 29%. Emergency visits are very costly, so their reduction is of importance. This study's objective was to evaluate the reasons for emergency department visits and determine potentially modifiable risk factors. This study retrospectively reviewed data queried from the Michigan Spine Surgery Improvement Collaborative (MSSIC) registry from July 2020 to November 2021. MSSIC is a multicenter (28-hospital) registry of patients undergoing cervical and lumbar degenerative spinal surgery. Adult patients treated for elective cervical and/or lumbar spine surgery for degenerative pathology (spondylosis, intervertebral disc disease, low-grade spondylolisthesis) were included. Emergency department visits within 90 days of surgery (outcome measure) were analyzed utilizing univariate and multivariate regression analyses. Of 16,224 patients, 2024 (12.5%) presented to the emergency department during the study period, most commonly for pain related to spinal surgery (31.5%), abdominal problems (15.8%), and pain unrelated to the spinal surgery (12.8%). On multivariate analysis, age (per 5-year increase) (relative risk [RR] 0.94, 95% CI 0.92-0.95), college education (RR 0.82, 95% CI 0.69-0.96), private insurance (RR 0.79, 95% CI 0.70-0.89), and preoperative ambulation status (RR 0.88, 95% CI 0.79-0.97) were associated with decreased emergency visits. Conversely, Black race (RR 1.30, 95% CI 1.13-1.51), current diabetes (RR 1.13, 95% CI 1.01-1.26), history of deep venous thromboembolism (RR 1.28, 95% CI 1.16-1.43), history of depression (RR 1.13, 95% CI 1.03-1.25), history of anxiety (RR 1.32, 95% CI 1.19-1.46), history of osteoporosis (RR 1.21, 95% CI 1.09-1.34), history of chronic obstructive pulmonary disease (RR 1.19, 95% CI 1.06-1.34), American Society of Anesthesiologists class > II (RR 1.18, 95% CI 1.08-1.29), and length of stay > 3 days (RR 1.29, 95% CI 1.16-1.44) were associated with increased emergency visits. The most common reasons for emergency department visits were surgical pain, abdominal dysfunction, and pain unrelated to index spinal surgery. Increased focus on postoperative pain management and bowel regimen can potentially reduce emergency visits. The risks of diabetes, history of osteoporosis, depression, and anxiety are areas for additional preoperative screening.

SNOT-22 subdomain outcomes following treatment for sinonasal malignancy: A prospective, multicenter study.

Patients with sinonasal malignancy (SNM) present with significant sinonasal quality of life (QOL) impairment. Global sinonasal QOL as measured by the 22-item Sinonasal Outcomes Test (SNOT-22) has been shown to improve with treatment. This study aims to characterize SNOT-22 subdomain outcomes in SNM. Patients diagnosed with SNM were prospectively enrolled in a multi-center patient registry. SNOT-22 scores were collectedat the time of diagnosis and through the post-treatment period for up to 5 years. Multivariable regression analysis was used to identify drivers of variation in SNOT-22 subdomains. Note that 234 patients were reviewed, with a mean follow-up of 22 months (3 months-64 months). Rhinologic, psychological, and sleep subdomains significantly improved versus baseline (all p<0.05). Subanalysis of 40 patients with follow-up at all timepoints showed statistically significant improvement in rhinologic, extra-nasal, psychological, and sleep subdomains, with minimal clinically important difference met between 2 and 5 years in sleep and psychological subdomains. Adjuvant chemoradiation was associated with worse outcomes in rhinologic (adjusted odds ratio (5.22 [1.69-8.66])), extra-nasal (2.21 [0.22-4.17]) and ear/facial (5.53 [2.10-8.91]) subdomains. Pterygopalatine fossa involvement was associated with worse outcomes in rhinologic (3.22 [0.54-5.93]) and ear/facial (2.97 [0.32-5.65]) subdomains. Positive margins (5.74 [2.17-9.29]) and surgical approach-combined versus endoscopic (3.41 [0.78-6.05])-were associated with worse psychological outcomes.Adjuvant radiation (2.28 [0.18-4.40]) was associated with worse sleep outcomes. Sinonasal QOL improvements associated with treatment of SNM are driven by rhinologic, extra-nasal, psychological, and sleep subdomains.