Registry Of Patients Research Articles

Endoscopist adenomas-per-colonoscopy detection rates and risk for postcolonoscopy colorectal cancer: data from the New Hampshire Colonoscopy Registry

Adenomas per colonoscopy (APC) may be a better measure of colonoscopy quality than adenoma detection rate (ADR) because it credits endoscopists for each detected adenoma. There are few data examining the association between APC and postcolonoscopy colorectal cancer (PCCRC) incidence. We used data from the New Hampshire Colonoscopy Registry to examine APC and PCCRC risk. We included New Hampshire Colonoscopy Registry patients with an index examination and at least 1 follow-up event, either a colonoscopy or a colorectal cancer (CRC) diagnosis. Our outcome was PCCRC defined as any CRC diagnosed≥6 months after an index examination. The exposure variable was endoscopist-specific APC quintiles of .25, .40, .50, and .70. Cox regression was used to model the hazard of PCCRC on APC, controlled for age, sex, year of index examination, index findings, bowel preparation, and having more than 1 surveillance examination. In 32,535 patients, a lower hazard for PCCRC (n= 178) was observed for higher APCs as compared to APCs of<.25 (reference): .25 to<.40: hazard ratio (HR), .35; 95% confidence interval (CI), .22-.56; .40 to<.50: HR, .31; 95% CI, .20-.49; .50 to<.70: HR, .20; 95% CI, .11-.36; and≥.70: HR, .19; 95% CI, .09-.37. When examining endoscopists with an ADR of at least 25%, an APC of<.50 was associated with a significantly higher hazard than an APC of≥.50 (HR, 1.65; 95% CI, 1.06-2.56). A large proportion of endoscopists-one-fifth (32 of 152; 21.1%)-had an ADR of≥25% but an APC of<.50. Our novel data demonstrating lower PCCRC risk in examinations performed by endoscopists with higher APCs suggest that APC could be a useful quality measure. Quality improvement programs may identify important deficiencies in endoscopist detection performance by measuring APC for endoscopists with an ADR of≥25%.

Survival of Patients With Head and Neck Merkel Cell Cancer

Merkel cell carcinoma (MCC) is an aggressive cutaneous neuroendocrine carcinoma. Due to its relatively low incidence and limited prospective trials, current recommendations are guided by historical single-institution retrospective studies. To evaluate the overall survival (OS) of patients in Canada with head and neck MCC (HNMCC) according to American Joint Committee on Cancer 8th edition staging and treatment modalities. A retrospective cohort study of 400 patients with a diagnosis of HNMCC between July 1, 2000, and June 31, 2018, was conducted using the Pan-Canadian Merkel Cell Cancer Collaborative, a multicenter national registry of patients with MCC. Statistical analyses were performed from January to December 2022. The primary outcome was 5-year OS. Multivariable analysis using a Cox proportional hazards regression model was performed to identify factors associated with survival. Between 2000 and 2018, 400 patients (234 men [58.5%]; mean [SD] age at diagnosis, 78.4 [10.5] years) with malignant neoplasms found in the face, scalp, neck, ear, eyelid, or lip received a diagnosis of HNMCC. At diagnosis, 188 patients (47.0%) had stage I disease. The most common treatment overall was surgery followed by radiotherapy (161 [40.3%]), although radiotherapy alone was most common for stage IV disease (15 of 23 [52.2%]). Five-year OS was 49.8% (95% CI, 40.7%-58.2%), 39.8% (95% CI, 26.2%-53.1%), 36.2% (95% CI, 25.2%-47.4%), and 18.5% (95% CI, 3.9%-41.5%) for stage I, II, III, and IV disease, respectively, and was highest among patients treated with surgery and radiotherapy (49.9% [95% CI, 39.9%-59.1%]). On multivariable analysis, patients treated with surgery and radiotherapy had greater OS compared with those treated with surgery alone (hazard ratio [HR], 0.76 [95% CI, 0.46-1.25]); however, this was not statistically significant. In comparison, patients who received no treatment had significantly worse OS (HR, 1.93 [95% CI, 1.26-2.96)]. In this cohort study of the largest Canada-wide evaluation of HNMCC survival outcomes, stage and treatment modality were associated with survival. Multimodal treatment was associated with greater OS across all disease stages.

Risk prediction model for mortality in microscopic polyangiitis: multicentre REVEAL cohort study

BackgroundTo establish refined risk prediction models for mortality in patients with microscopic polyangiitis (MPA) by using comprehensive clinical characteristics.MethodsData from the multicentre Japanese registry of patients with vasculitis (REVEAL cohort) were used in our analysis. In total, 194 patients with newly diagnosed MPA were included, and baseline demographic, clinical, laboratory, and treatment details were collected. Univariate and multivariate analyses were conducted to identify the significant risk factors predictive of mortality.ResultsOver a median follow-up of 202.5 (84–352) weeks, 60 (30.9%) of 194 patients died. The causes of death included MPA-related vasculitis (18.3%), infection (50.0%), and others (31.7%). Deceased patients were older (median age 76.2 years) than survivors (72.3 years) (P < 0.0001). The death group had shorter observation periods (median 128.5 [35.3–248] weeks) than the survivor group (229 [112–392] weeks). Compared to survivors, the death group exhibited a higher smoking index, lower serum albumin levels, higher serum C-reactive protein levels, higher Birmingham Vasculitis Activity Score (BVAS), higher Five-Factor Score, and a more severe European Vasculitis Study Group (EUVAS) categorization system. Multivariate analysis revealed that higher BVAS and severe EUVAS independently predicted mortality. Kaplan–Meier survival curves demonstrated lower survival rates for BVAS ≥20 and severe EUVAS, and a risk prediction model (RPM) based on these stratified patients into low, moderate, and high-risk mortality groups.ConclusionsThe developed RPM is promising to predict mortality in patients with MPA and provides clinicians with a valuable tool for risk assessment and informed clinical decision-making.

Increased Grades of Rectal Intussusception: Role of Decline in Pelvic Floor Integrity and Association With Dyssynergic Defecation.

The natural history of rectal intussusception (RI) is poorly understood. We hypothesized that decline in pelvic floor integrity and function leads to increasing RI grades. Retrospective analysis of a registry of patients with defecatory disorders with high-resolution anorectal manometry and magnetic resonance defecography was performed. Association of risk factors on increasing RI grades was assessed using logistic regression. Analysis included a total of 238 women: 90 had no RI, 43 Oxford 1-2, 49 Oxford 3, and 56 Oxford 4-5. Age ( P = 0.017), vaginal delivery ( P = 0.008), and prior pelvic surgery ( P = 0.032) were associated with increased Oxford grades. Obstructive defecation symptoms and dyssynergic defecation were observed at relatively high rates across groups. Increased RI grades were associated with less anal relaxation at simulated defecation yet, higher rates of normal balloon expulsion ( P < 0.05), linked to diminished anal sphincter. Indeed, increased RI grades were associated with worsening fecal incontinence severity, attributed to higher rates of anal hypotension. Levator ani laxity, defined by increased levator hiatus length and its excessive descent at straining, was associated with increasing RI grades, independent of age, history of vaginal delivery, and pelvic surgeries and could independently predict increased RI grades. Concurrent anterior and posterior compartments, and visceral prolapse were associated with higher Oxford grades. Our data suggest that decline in pelvic floor integrity with abnormal levator ani laxity is associated with increased RI grades, a process that is independent of age, history of vaginal deliveries, and/or pelvic surgeries, and perhaps related to dyssynergic defecation.

Associations Between Neighborhood-Level Income and Triple-Negative Breast Cancer in a Majority-Minority Population.

Previous studies on disparities in triple-negative breast cancer (TNBC) focus on race/ethnicity, with few exploring the impact of contextual factors such as neighborhood-level income. This study evaluates the effect of neighborhood-level income on disparities in TNBC among a racially and ethnically diverse cohort, after accounting for granular individual-level risk factors of TNBC. Patients with stage I-IV breast cancer from 2005 to 2017 were identified from our local tumor registry. The primary outcome was diagnosis of TNBC. Using 5-years estimates from the American Community Survey, we obtained median household income for each census tract which was categorized into quartiles. Mixed effects logistic regression was conducted and stratified by race and ethnicity, controlling for individual-level sociodemographic, comorbidities, and tumor characteristics. Among 5377 breast cancer registry patients, 16.5% were diagnosed with TNBC. The majority were Hispanic (50.1%) followed by non-Hispanic Black (NHB) (28.0%). After controlling for individual-level covariables including race and ethnicity, comorbidities, and tumor characteristics, women from low-income neighborhoods had increased odds of TNBC compared with other breast cancer subtypes, compared with those in high-income neighborhoods [odds ratio (OR) 1.33; 95% confidence interval (CI) 1.04, 1.70, p < 0.001]. In stratified analyses, NHB patients from low-income neighborhoods had two times the odds of TNBC diagnosis compared with those from high-income neighborhoods (OR 2.11; 95% CI 1.02, 4.37). We found that living in a low-income neighborhood is associated with an increased odds of TNBC independent of granular individual-level TNBC risk factors, particularly NHB race. More striking, NHB living in low-income neighborhoods had increased odds of TNBC compared with NHB living in high-income neighborhoods. Our results suggest potential unaccounted gene-environment and/or social (api)genomicinteractions between neighborhood-level income and TNBCsubtype development.

A Deep Learning Pipeline for Assessing Ventricular Volumes from a Cardiac MRI Registry of Patients with Single Ventricle Physiology.

Purpose To develop an end-to-end deep learning (DL) pipeline for automated ventricular segmentation of cardiac MRI data from a multicenter registry of patients with Fontan circulation (Fontan Outcomes Registry Using CMR Examinations [FORCE]). Materials and Methods This retrospective study used 250 cardiac MRI examinations (November 2007-December 2022) from 13 institutions for training, validation, and testing. The pipeline contained three DL models: a classifier to identify short-axis cine stacks and two U-Net 3+ models for image cropping and segmentation. The automated segmentations were evaluated on the test set (n = 50) by using the Dice score. Volumetric and functional metrics derived from DL and ground truth manual segmentations were compared using Bland-Altman and intraclass correlation analysis. The pipeline was further qualitatively evaluated on 475 unseen examinations. Results There were acceptable limits of agreement (LOA) and minimal biases between the ground truth and DL end-diastolic volume (EDV) (bias: -0.6 mL/m2, LOA: -20.6 to 19.5 mL/m2) and end-systolic volume (ESV) (bias: -1.1 mL/m2, LOA: -18.1 to 15.9 mL/m2), with high intraclass correlation coefficients (ICCs > 0.97) and Dice scores (EDV, 0.91 and ESV, 0.86). There was moderate agreement for ventricular mass (bias: -1.9 g/m2, LOA: -17.3 to 13.5 g/m2) and an ICC of 0.94. There was also acceptable agreement for stroke volume (bias: 0.6 mL/m2, LOA: -17.2 to 18.3 mL/m2) and ejection fraction (bias: 0.6%, LOA: -12.2% to 13.4%), with high ICCs (>0.81). The pipeline achieved satisfactory segmentation in 68% of the 475 unseen examinations, while 26% needed minor adjustments, 5% needed major adjustments, and in 0.4%, the cropping model failed. Conclusion The DL pipeline can provide fast standardized segmentation for patients with single ventricle physiology across multiple centers. This pipeline can be applied to all cardiac MRI examinations in the FORCE registry. Keywords: Cardiac, Adults and Pediatrics, MR Imaging, Congenital, Volume Analysis, Segmentation, Quantification Supplemental material is available for this article. © RSNA, 2023.

PROMISE Registry: A prostate cancer registry of outcomes and germline mutations for improved survival and treatment effectiveness.

Recently approved treatments and updates to genetic testing recommendations for prostate cancer have created a need for correlated analyses of patient outcomes data via germline genetic mutation status. Genetic registries address these gaps by identifying candidates for recently approved targeted treatments, expanding clinical trial data examining specific gene mutations, and understanding effects of targeted treatments in the real-world setting. The PROMISE Registry is a 20-year (5-year recruitment, 15-year follow-up), US-wide, prospective genetic registry for prostate cancer patients. Five thousand patients will be screened through an online at-home germline testing to identify and enroll 500 patients with germline mutations, including: pathogenic or likely pathogenic variants and variants of uncertain significance in genes of interest. Patients will be followed for 15 years and clinical data with real time patient reported outcomes will be collected. Eligible patients will enter long-term follow-up (6-month PRO surveys and medical record retrieval). As a virtual study with patient self-enrollment, the PROMISE Registry may fill gaps in genetics services in underserved areas and for patients within sufficient insurance coverage. The PROMISE Registry opened in May 2021. 2114 patients have enrolled to date across 48 US states and 23 recruiting sites. 202patients have met criteria for long-term follow-up. PROMISE is on target with the study's goal of 5000 patients screened and 500 patients eligible for long-term follow-up by 2026. The PROMISE Registry is a novel, prospective, germline registry that will collect long-term patient outcomes data to address current gaps in understanding resulting from recently FDA-approved treatments and updates to genetic testing recommendations for prostate cancer. Through inclusion of a broad nationwide sample, including underserved patients and those unaffiliated with major academic centers, the PROMISE Registry aims to provide access to germline genetic testing and to collect data to understand disease characteristics and treatment responses across the disease spectrum for prostate cancer with rare germline genetic variants.

Temporal changes in stroke and heart failure following first-time atrial fibrillation/flutter in patients under 65 years of age: A Danish nationwide study

Abstract Background The incidence of atrial fibrillation/flutter (AF) has increased throughout the past two decades - also for patients under 65 years of age. Whether this increment in patients with AF under 65 years of age also influences the subsequent incidence of ischaemic stroke (stroke) and heart failure (HF) is yet to be elucidated. This patient group are of special interest as this population often is considered at low risk of stroke. Methods Using Danish nationwide registries, we identified all patients from 18–65 years with a first-time AF-diagnosis in 2000-2018. The cohort was categorised according to calendar periods into five groups: 2000-200, 2003-2006, 2007-2010, 2011-2014, and 2015-2018. Crude incidence rate (IR) of stroke and HF per 1,000 person years (PY) were calculated. The cumulative incidence (CI) of stroke and HF during one year of follow-up was computed accounting for death as a competing risk. The reverse Kaplan-Meier estimator was used to examine mortality during one year follow-up. Multivariable Cox proportional hazard analysis was used to compare outcomes between calendar periods with 2000-2002 as comparative reference. Hazard ratios (HR) were reported with 95% confidence intervals (95% CI). Results In this study 51,137 patients were included; 6,911 (median age 56, 64.5% males, 22.0% on OAC) in 2000-2002, 9,964 (median age 58, 65.5% males, 26.4% on OAC) in 2003-2006, 11,538 (median age 58, 64.7% males, 23.9% on OAC) in 2007-2010, 11,764 (median age 58, 63.6% males, in 29.2% on OAC) in 2011-2014, and 10,960 (median age 56, 65.9% males, 39.5% on OAC) in 2015-2018. For stroke, crude IR/1,000 PY [95% CI] declined through calendar time as seen in the Figure. The crude IR were 10.4 [8.0;13.5] in 2000-2002 and 6.3 [4.9;8.0] in 2015-2018 with corresponding CIs of 1.0%, 0.9%, 0.9%, 0.8%, and 0.6%, respectively (p-value for difference=0.08). The corresponding adjusted HRs [95% CI] were 0.94 [0.66;1.35] for calendar period 2003-2006, 0.87 [0.61;1.24] for 2007-2010, 0.86 [0.61;1.23] for 2011-2014, and 0.61 [0.41;0.91] for 2015-2018 as compared with 2000-2002. As seen in the Figure crude IR [95% CI] for HF were stagnant over time with 37.2 [32.4;42.8] in 2000-2002 and 38.3 [34.7;42.3] in 2015-2018 with corresponding CIs of 3.4%, 3.3%, 3.5%, 3.4%, and 3.3%, respectively (p-value for difference=0.89). The corresponding adjusted HRs [95% CI] were 0.93 [0.79;1.10] for calendar period 2003-2006, 0.99 [0.84;1.17] for 2007-2010, 0.99 [0.84;1.16] for 2011-2014, and 1.02 [0.86;1.20] for 2015-2018 as compared with 2000-2002. Mortality with one year of follow-up was 3.8%, 4.4%, 4.4%, 4.5%, and 3.7% in calendar period 1-5 respectively (p-value for difference=0.38). Conclusion From nationwide registries in patients with atrial fibrillation/flutter under 65 years of age, we found a stepwise decline in one-year rates of ischaemic stroke with more recent calendar periods. Heart failure and mortality incidence were stable across calendar time.Incidence rates of ischemic stroke

Association between high platelet reactivity and early stent thrombosis in patients with drug-eluting stent implantation

Abstract Background Stent thrombosis (ST) is a potentially fatal complication after percutaneous coronary intervention (PCI). The association between P2Y12 reaction unit (PRU) level and stent thrombosis occurrence is not fully elucidated. Methods Based on the multicenter, observational PTRG-DES (Platelet function and genoType-Related long-term proGnosis in DES-treated patients) registry of patients with drug-eluting stents (DES) implantation, a total of 11,714 patients with PRU values were identified. The independent predictors of early stent thrombosis (EST) were assessed. The primary outcome after EST was the composite of cardiac death, myocardial infarction and any revascularisation. Key secondary outcomes were all-cause death, cardiac death, myocardial infarction, and any revascularisation. Results EST, defined as definite ST in less than 1 month after index PCI, was identified in a total of 51 patients. The PRU value was significantly higher in the EST group (263.5 ± 70.8 vs. 217.5 ± 78.7, p&amp;lt;0.001). In multivariable analysis, having a PRU value of ≥252 (OR, 5.10; 95% CI, 1.58-16.46; p=0.006) and an ARU value of ≥414 (OR 4.85; 95% CI, 1.07-21.97; p=0.040) were significant predictors of EST. The use of first-generation DES (OR 3.56; 95% CI, 0.98-12.99; p=0.054) also posed a higher risk for EST occurrence with a borderline significance. Cumulative incidence of the primary composite outcome was significantly higher in patients with EST (HR 18.7; 95% CI 12.8-27.3; p&amp;lt;0.001). Conclusion In patients treated with clopidogrel after successful DES implantation, EST was associated with higher PRU values, and a greater rate of adverse outcomes, including all-cause death and MI.

Heart failure early post-discharge appointment: a 1.5-year single-centre experience

Abstract Background According to Heart Failure (HF) guidelines, a follow-up visit should be conducted within 1 to 2 weeks after hospital discharge to monitor signs and symptoms of HF, optimize therapy, and evaluate treatment side effects. Retrospective studies have shown that this approach is associated with lower 30-day readmission rates. Purpose Our aim is to describe the role of early post-discharge appointment in the management of HF patients and to evaluate prognostic factors after HF hospitalization. Methods We conducted a single-centre prospective registry of consecutive patients evaluated in the early post-discharge appointment at our centre, from March 2021 to September 2022. HF symptoms, vital signs, blood test results, treatment decision, and 90-day HF events were recorded. Results Overall, 153 patients were included (mean age 65.7 ± 13.0 years, 63.4% male). The mean time from hospital discharge to post-discharge appointment was 13.4 ± 5.7 days. Left ventricle ejection fraction was reduced in 83.6% (n = 127) of patients. Guideline-directed medical treatment prescribed at discharge, as well as up-titration and withdrawal patterns at the post-discharge appointment, are presented in Table 1. At the post-discharge appointment, 34.3% of patients (n = 35) presented with drug adverse effects, most often including hyperkalemia (17.5%, n = 22), acute kidney injury (9.9%, n = 12), and hypotension (3.9%, n = 6). Of those evaluated at the post-discharge appointment, 11.2% (n = 17) were scheduled to another appointment one week later, for early re-evaluation, 90.1% (n = 137) were followed-up in the standard HF ambulatory program, and 2.6% (n = 4) were hospitalized. The serum creatinine (1.10 [0.87 – 1.36] mg/dL vs 1.40 [1.09 – 1.95] mg/dL, p&amp;lt;0.001), the serum C cystatin (1.50 [1.25 – 1.98] mg/dL vs 1.97 [1.54 – 2.46] mg/dL, p = 0.007) and the NT-proBNP levels (1859 [977 – 4877] mg/dL vs 5928 [2817 – 11957] mg/dL, p = 0.013), measured at the time of the post-discharge appointment, were found to be associated with HF events within 90 days (urgent HF visit or HF hospitalization). An NT-proBNP level above 2400 pg/mL adjusted to C cystatin was found to be a strong predictor of 90-day HF events (OR 9.855, 95% CI 2.657 – 36.550, p = 0.001). This model yielded a good prognostic performance (AUC 0.790, CI 95% 0.689-0.890, p&amp;lt;0.001). Conclusions Early evaluation of HF patients after hospital discharge allows for guideline-directed medical therapy up-titration and early detection of drug adverse effects. The NTproBNP level and kidney function, assessed early after discharge, have been found to be strong predictors of 90-day HF events, indicating which patients would benefit most from a stricter follow-up program. Table 1 – Guideline-directed medical therapy patterns of prescription both at hospital discharge and during the early post-discharge appointment. ACE, angiotensin converting enzyme; ARA, aldosterone receptor antagonist, MRA, mineralocorticoid receptor antagonist.

Stroke, mortality, and major bleeding among patients with atrial fibrillation and chronic kidney disease; insights from a contemporary large-scale population study

Abstract Introduction Chronic kidney disease (CKD) and atrial fibrillation (AF) frequently coexist, sharing a complex interplay. Although both conditions are prothrombotic, the prognostic role of CKD in AF remains uncertain, and anticoagulation effect on clinical outcomes is unclear. Methods A historical population-based study based on the "Clalit" health organization computerized database, including patients &amp;gt;21 years first diagnosed with AF between January 1st, 2010, and January 1st, 2020. The study population was stratified according to the estimated glomerular filtration rate (eGFR) at baseline to: No or mild CKD (eGFR≥60mL/min/1.73m2), moderate-CKD (eGFR above 30 and below 60 mL/min/1.73m2) and advanced-CKD (eGFR≤30 mL/min/1.73m2). Multivariable Cox-regression analyses were performed to evaluate the association between CKD stages and the 5-year risk of death, stroke, intracranial hemorrhage (ICH), and gastrointestinal bleeding (GIB). The association of anticoagulation treatments and possible interaction with CKD with the risk for the study outcomes were also examined. Results We identified 87,804 patients with incident AF. Of them, 3.2% had advanced CKD, and 25% had moderate CKD. 39,421 patients (45%) received anticoagulation. In multivariable models, moderate and advanced CKD were associated with increased risk for death in an incremental manner (moderate CKD: adjusted-hazard ratio (aHR) 1.17; 95% CI 1.14-1.20, p&amp;lt;0.001) (advanced CKD: aHR 1.85; 95% CI 1.76 -1.96; p&amp;lt;0.001). Both moderate CKD (aHR 1.1; 95% CI 1.00-1.20, p&amp;lt;0.05) and advanced CKD (aHR 1.37; 95% CI 1.13-1.67; p=0.001) were associated with increased risk of stroke. Renal function was not associated with increased risk for ICH, yet it was associated with increased risk of GIB. DOAC therapy reduced the risk of stroke (aHR 0.7; 95% CI 0.57-0.86, p=0.001) and death (aHR 0.83; 95% CI 0.77-0.78, p&amp;lt;0.001) while warfarin treatment did not. The association of anticoagulation treatment with reduced risk for stroke was consistent across CKD strata (p-for-interaction=0.19). Conclusions In this contemporary registry of AF patients, worse CKD was incrementally and independently associated with an increased risk of death, stroke and gastrointestinal bleeding among patients with AF. DOAC therapy was associated with a reduced risk for stroke and death without evident increase in ICH or GI bleeding. The inverse association between DOACs and stroke was consistent across all CKD categories. If confirmed by others, CKD ought to be added to stroke risk scores in AF.5 year stroke risk5 year death risk

German Cardiac Arrest Registry (G-CAR): results of the pilot phase

Abstract Background/Introduction In Europe, over 30.000 persons per year suffer from out-of-hospital cardiac arrest (OHCA). Despite medical progress, survival rates with good neurological outcome remain low. For many important clinical issues, no or only insufficient evidence from randomised trials is available. Therefore, a systemic and standardised acquisition of the treatment course and of the outcome of OHCA patients is warranted. Purpose The German Cardiac Arrest Registry (G-CAR) is an observational, prospective, multicentre registry under the aegis of the German National Cardiac Society. It determines the characteristics, initial treatment strategies, invasive procedures, revascularisation therapies and the use of mechanical circulatory support devices with a focus on extracorporeal cardiopulmonary resuscitation (eCPR). It includes a prospective 12-month follow-up evaluating mortality, neurological outcomes and several patient-reported outcomes in the psychosocial domain, figure 1. Herein, we describe the first results of the pilot phase; more data will be available at the time of the ESC congress. Methods and Results In a pilot phase of 16 months, 15 national centres included 480 consecutive OHCA patients ≥18 years. Median age of the patients was 67 (interquartile range 57;76) years, 74.4% were male. 77.5% of the events were witnessed; bystander CPR was performed in 77.4%. Initial rhythm was shockable in 46.5%. 28.5% of the patients had ongoing CPR at hospital admission. eCPR was performed in 14.1% of the patients. Main presumed underlying causes of CPR were acute coronary syndromes and/or cardiogenic shock in 53.3% followed by primary arrhythmias (7.9%) and hypoxia (5.2%). In 35.2%, ST-segment elevations were observed after return of spontaneous circulation, mostly (62.1%) with an anterior location. In total, 66.6% of the patients underwent coronary angiography. In 71.5%, angiography was performed immediately, in 23.8% within 24 hours and in 4.7% in an elective setting. The LAD was the culprit lesion in 35.8%, the RCA in 17.7%, the LCX in 10.6% and the LM in 5.1%. In 30.3%, there was either no or an unclear culprit lesion. Regarding the strategy of percutaneous coronary intervention (PCI), culprit-only PCI was performed in 74.5%, multivessel PCI in 25.5%. Targeted temperature management was performed in 79.8%, with an invasive approach and non-invasive approach in approximately 50% each. In-hospital mortality was 69.2%, with anoxic brain damage being the main presumed cause of death (37.3%) followed by circulatory failure in 26.2%. Conclusions G-CAR is a multicenter German registry for adult OHCA patients including long-term follow-up. Primary aim is a better understanding of the determinants of acute and long-term outcomes with the perspective of an optimised treatment. Parallel to further in-depth analyses of the pilot phase including patient-reported outcomes, scaling up of G-CAR to a national level is envisaged.Registry flow-chartFirst results pilot phase G-CAR

Predictors of major adverse cardiovascular events in patients with severe aortic stenosis awaiting aortic valve replacement

Abstract Background Severe aortic stenosis (AS) is a progressive disease associated with an increased risk of heart failure (HF) and mortality if left untreated. Aortic valve replacement (AVR) is the treatment of choice. However, it is not always immediately available, and some patients have experienced major cardiovascular events (MACE) while waiting for AVR. The identification of reliable predictors of MACE can help clinicians risk-stratify severe AS patients and tailor their management to prevent adverse outcomes. Purpose We aimed to evaluate predictors of MACE in real-world patients with severe AS who are waiting for AVR. Methods We conducted a prospective registry of consecutive patients discussed in the Heart Team meeting of a single centre, between January 2018 and June 2021. All patients with severe AS were included. For each patient we recorded demographic data, blood test results, echocardiogram parameters, and MACEs (a composite of death, HF hospitalization, non-fatal acute myocardial infarction, and non-fatal stroke). MACEs were recorded until the patient underwent AVR. The median follow-up time was 187 days (IQR 59-352). Results Overall, 235 patients were included (mean age 76.7±10.7 years, 48.1% male). Previous HF hospitalization (HR 2.77, 95% CI 1.66 – 4.62), HF symptoms with New York Heart Association (NHYA) class ≥3 (HR 2.64, 95% CI 1.58–4.39), and the presence of left ventricular dysfunction (HR 2.86, 95% CI 1.71–4.78) were independent predictors of MACE (Figure 1). The presence of pulmonary hypertension (HR 2.16, 95CI 1.27–3.66), but not right ventricular dysfunction (HR 2.34, 95CI 0.45–12.08, p=0.31), was associated with MACE until AVR. Concomitant moderate to severe tricuspid regurgitation (HR 10.88, 95CI 1.41–83.94) and moderate to severe mitral regurgitation (HR 5.91, 95CI 1.50–23.34) were associated with a worse prognosis, even when adjusted for other relevant MACE predictors. Laboratory data such as serum creatinine, haemoglobin, and NT-proBNP levels were not associated with the occurrence of MACE in this population (HR 1.00). Past medical history of hypertension, diabetes, chronic kidney disease, and chronic obstructive pulmonary disease were not associated with MACE. Age was a limited predictor of MACE (HR 1.03, 95CI 1.00 – 1.06, p=0.04). Conclusion Previous HF hospitalization, NYHA class ≥3 symptoms, left ventricular dysfunction, and pulmonary hypertension were independent predictors of MACE in patients with severe AS awaiting AVR. Additionally, concomitant moderate to severe tricuspid and mitral regurgitation were also associated with worse prognosis. These findings may help identify those at high risk of MACE who would benefit most from early intervention and close monitoring.

Impact of oral anticoagulants in frail atrial fibrillation patients: a report from an observational registry of european patients

Abstract Background The last years showed a substantial increase of interest about the clinical issue of frailty among patients with cardiovascular diseases. Impact of frailty in atrial fibrillation (AF) has been examined in terms of management, quality of life and increased risk of outcomes; nonetheless, the impact of treatment with oral anticoagulants (OAC) remains suboptimally understood. Purpose To analyse the impact of OAC in a cohort of frail AF patients. Methods We used data from a European-wide prospective observational AF registry. Frailty was evaluated with a 40-items frailty index (FI) built according to the cumulative deficit method proposed by Rockwood and Mitnitski. OAC treatment was evaluated at baseline. A net clinical outcome (NCO) of all-cause death, major adverse cardiovascular outcomes, and major bleeding, as well as the single components were the study outcomes. Results Among 10,172 patients available for this analysis, 2,171 (21.3%) were frail. AF frail patients had a mean (SD) age of 71.7 (9.8) years and were 1,073 (49.4%) females. Overall, 1,801 (83.0%) were treated with OAC, of which 1,232 (68.4%) prescribed with vitamin K antagonist (VKA) and 569 (31.6%) prescribed with non-vitamin K antagonist oral anticoagulants (NOACs). Over a mean (SD) follow-up time of 1.56 (0.74) years there were 571 (26.3%) NCO events. Frail patients prescribed with OAC had a lower rate of NCO compared to those not prescribed (27.1% vs. 44.6%, p&amp;lt;0.001). After adjustments, use of OAC was associated with lower risk of NCO and all the other secondary outcomes (Table 1). Regarding the type of OAC, patients prescribed with NOACs reported a lower rate of NCO compared to those prescribed with VKAs (22.7% vs. 29.1%). After adjustments, use of NOACs was associated with a lower risk of NCO and all the other secondary outcomes, except for major bleeding (Table 1). When comparing patients with FI &amp;lt;80th percentile with those with FI ≥80th percentile, adjusted analysis showed that in the FI &amp;lt;80th group the use of OAC was consistently associated with lower risk of all outcomes (except for major bleeding), with a non-statistically significant trend seen in those with FI ≥80th percentile treated with OAC (Table 1). Conclusions In frail AF patients, use of OAC was associated with a lower risk of outcomes, as well as the use of NOACs compared with VKAs. In patients with a very high frailty burden the benefits of OAC may be attenuated.

The efficacy of excimer laser coronary atherectomy in ST-elevation myocardial infarction: a report from the STELA registry

Abstract Backgrounds Previous studies have demonstrated potential effect of excimer laser coronary atherectomy (ELCA) to reduce thrombus burden within the vessel, and ELCA has been used during primary PCI for acute coronary syndrome. Especially, the culprit lesions of ST-segment elevation myocardial infarction (STEMI) are generally accompanied by large thrombus burden. Nevertheless, the clinical effectiveness of ELCA use for the culprit lesions of STEMI has not been elucidated. Purpose To investigate the clinical outcomes of the STEMI patients who were treated with ELCA during primary PCI in comparison with those treated without ELCA. Methods We conducted the registry study of STEMI for the assessment of the efficacy of ELCA, which was an observational multicenter registry of the consecutive patients undergoing primary PCI for STEMI within 24 hours from the onset between 2015 and 2019. The patients were divided into two groups according to the use of ELCA during primary PCI: ELCA group and non-ELCA group. The primary endpoint was the major adverse cardiovascular event (MACE), which was defined as the composite of cardiovascular death (CVD), target vascular revascularization and non-fatal AMI. Propensity score (PS) matching was performed to adjust the bias of confounding factors using 1:1 nearest-neighbor matching without replacement. PS was yielded from clinical characteristics, baseline angiographic findings, and hemodynamic status that were imbalanced between the two groups. Results A total of 2593 patients, 424 patients in ELCA group and 2169 patients in non-ELCA group, were included in the analysis. PS matched cohort comprised 824 patients including 412 ELCA and 412 non-ELCA group. Median follow-up duration in the total cohort was 816 (394-1388) days. In the total cohort, baseline characteristics showed that younger age, less prevalent hypertension, and more frequent prior statin use in ELCA group than in non-ELCA group. In terms of clinical outcomes, ELCA group showed a significantly lower rate of CVD than non-ELCA group (4.3% vs 7.5%, P for log-rank = 0.03), whereas MACE rate was similar between the two groups (HR:1.00 95%CI 0.74-1.34, P=0.99). In the PS matched cohort, the baseline characteristics were well balanced. Clinical outcomes including MACE and CVD were comparable between the two groups (MACE HR:1.13 95%CI 0.76-1.66, P=0.53 and CVD HR0.70 95%CI 0.38-1.29 P=0.25). In the subgroup analysis, MACE rate was lower in ELCA group than in non-ELCA group in the patients who presented with Killip class III or IV (P for interaction &amp;lt;0.01) (Abstract Picture 1). Conclusions The use of ELCA was not associated with improved MACEs in both total cohort and the PS matched cohort, whereas subgroup analysis suggested a potential benefit of ELCA in patients with heart failure. Further prospective investigations are warranted.Forest Plots for Subgroup Analysis

A prospective, observational multicenter registry of heart failure patients in Germany: preliminary results of the ongoing H2-registry

Abstract Background Heart failure (HF) is a highly prevalent condition affecting 1-2% of the adult population in Europe. Despite pioneering improvements in HF treatment during the last two decades, hospitalization and mortality rates remain relatively high. Gathering real-world data on HF populations is crucial especially in the light of newly emerging therapeutic approaches. Purpose The H2-registry was set up in 2021 to provide up-to-date, real-world data on a contemporary cohort of hospitalized HF patients in Germany using a standardized set of outcome measures. Methods The ongoing H2-registry represents a prospective, investigator-initiated, multicenter observational registry. Inpatients ≥18 years of age with a present diagnosis of chronic or acute HF are recruited in secondary and tertiary hospitals throughout Germany. Patients are excluded if they present in any kind of shock during index hospitalization, or if they previously underwent heart transplantation or ventricular assist device therapy. Routine follow-up (FU) is conducted every 6 months. A standardized set of variables according to the International Consortium of Health Outcome Measurements (ICHOM) including a pre-defined selection of questionnaires to collect patient-reported outcome measures (PROMs) is used to objectively monitor the course of disease. Results Until the reference date 12/31/22, a total of 2,190 patients were included in ten active study centers. Mean age was 72 years, 36.8% were female, and mean left-ventricular ejection fraction (LVEF) was 43.4% (38.1% had an LVEF of ≤ 40%). In-hospital mortality at index case was 1.3%. Within the cohort with completed 6-month FU comprising of 976 patients, all-cause mortality was 11.3% (110). In addition, 24.2% (209) in the survival cohort had at least one HF-related re-hospitalization. Numbers for all-cause mortality and re-hospitalizations at 12-month FU were 21.3% (71) and 32.8% (86), respectively. Evaluations of Kansas City Cardiomyopathy Questionnaire (KCCQ-12) scores showed a significant improvement overall and in all sub-categories (p &amp;lt; 0.001) at 6- and 12-month FU. Conclusions The H2-registry currently represents the largest ongoing prospective registry of HF inpatients in Germany. Our preliminary data highlights the pronounced mortality risk and healthcare burden in this cohort. However, HF-related therapies initiated during the course of a hospitalization have the potential to significantly improve patients’ quality of life. In the near future, it its foreseeable that the actively recruiting H2-registry based on ICHOM-standards will markedly contribute to the collection of real-world data on HF patients.

The power of optimal medical therapy in heart failure with secondary mitral regurgitation

Abstract Background Guideline-directed medical therapy (GDMT) for the management of heart failure (HF) may impact on the frequency of severe secondary mitral regurgitation (SMR). Objective To evaluate the impact of optimization of GDMT on the grade of SMR in a cohort of HF patients managed in a multidisciplinary HF clinic and to assess predictors and prognosis of deterioration of SMR. Methods In a prospective, consecutive, observational registry of HF patients, a 2-dimensional transthoracic echocardiography was performed at baseline and at 1 year of follow-up. Patients treated with surgical or interventional mitral valve repair were excluded. The primary endpoint was all-cause death. Results Of a total of 2.980 HF patients, 1814 patients had 2 echocardiograms performed 1 year apart. At baseline, 99 patients had a severe SMR (5.5%), 389 (21.4%) moderate and the remainder had mild, trace or none SMR. After 1-year, 80.8% of those with baseline severe SMR presented a regression to non-severe SMR, 66.6% of those with moderate SMR regressed to mild SMR and 1.1% of those with non-severe SMR at baseline worsened to severe SMR. Older age (OR 1.42 per every decade; 95% CI 1.19-1.69, p&amp;lt;0.001), ischaemic aetiology of HF (OR 1.64; 95% CI 1.11-2.42, p&amp;lt;0.001) and baseline NTproBNP (OR 1.19; 95% CI 1.08-1.32, p&amp;lt;0.001) were independently associated with worsening of SMR at 1 year of follow-up. Patients with baseline severe SMR that improved at 1 year had a similar risk of the primary endpoint to those with non-severe SMR at both time points (HR 0.93; 95% CI 0.62-1.42; p=0.75), even after adjusting for age, sex and LVEF (HR 0.99; 95% CI 0.65-1.52; p= 0.98). On the contrary, patients with non-severe SMR that worsen showed the worst prognosis (Figure 1). Conclusions Most of the patients with HF and severe SMR show a regression of SMR within 1 year of GDMT. Patients with baseline severe SMR that improved at 1 year have a similar prognosis than those with non-severe SMR at both time points. Older age, ischaemic aetiology and higher levels of NTproBNP were associated with deterioration of SMR.Table 1.Population characteristicsFigure 1.Survival curves

Impact of high-profile transvalvular pumps in heasrt failure related cardiogenic shock

Abstract Background Heart failure-related cardiogenic shock (HF-CS) not related to acute MI is a leading cause of CS.(1) Congestion is a major predictor of mortality among patients with HF-CS, for whom in-hospital mortality remains between 25-40%.(2,3) Both low-profile (Impella CP) and high-profile (Impella 5.0/5.5) transvalvular pumps are used to manage these patients. In the last few years, use of Impella 5.0/5.5 pumps in these patients is increasing, although it is often used as an escalation strategy from other temporary mechanical circulatory support (tMCS) devices. Purpose To assess the impact of LV unloading using high profile transvalvular pump (Impella 5.0/5.5) compared to a low-profile pump (Impella CP) on outcomes in HF-CS. Methods The Cardiogenic Shock Working Group (CSWG) is a large, multi-center international prospective registry of CS patients.(1) For this analysis, we retrospectively reviewed patients with HF-CS who underwent Impella 5.0/5.5 therapy for HF-CS and compared them to patients who underwent an Impella CP. Patients who received an Impella device as part of their escalation strategy from another device (IABP) or concomitant or de-escalation strategy with ECMO were excluded. Results Of the 2,755 patients with HF-CS, 125 patients received an Impella 5.0/5.5 while 152 patients received an Impella CP alone; 13 patients were escalated from an Impella CP to 5.0/5.5 pump. Of these 292 patients who either received an Impella CP or 5.0/5.5 or a combination of the two, 228(78%) were male, 208(71%) were white with a mean LVEF at presentation of 19%. About a third (n=78, 27%) presented with de-novo HF-CS while 214(73%) were acute on chronic HF-CS. In-hospital mortality in the entire HF-CS cohort was 717(26%). Unadjusted mortality was higher in those who underwent Impella CP alone (n= 57; 38%) compared to patients with Impella 5.0/5.5 (n=27, 23%; p=0.01). This improvement in mortality was seen in acute on chronic HF-CS with Impella 5.5/5.0 vs CP (41% vs 26%, p=0.02), and as a trend in de-novo HF-CS (30% vs 14%, p=0.13). More patients on Impella 5.0/5.5 went on to receive heart replacement therapies (durable LVAD or heart transplantation) compared to Impella CP (56% vs 9%, p&amp;lt;0.001). Conclusion(s) Use of a high-profile transvalvular pump (Impella 5.0/5.5) was associated with improved mortality compared to a low-profile transvalvular pump (Impella CP) in HF-CS.

Importance of hospital and clinical factors in predicting of 30-day mortality in Takotsubo syndrome: data from the Swedish Coronary Angiography and Angioplasty Registry

Abstract Background Takotsubo syndrome (TS) is an acute heart failure condition that presents with symptoms similar to acute myocardial infarction. TS is often triggered by emotional or physical stress and is an important cause of morbidity and mortality but predictors of mortality in TS patients are not well understood. There is a need to identify high-risk patients and tailor treatment accordingly. Purpose The purpose of this study was to assess the importance of various clinical factors in predicting 30-day mortality in TS patients using a machine-learning algorithm capable of identifying complex relationships between variables. Methods We analyzed data from the nationwide Swedish Coronary Angiography and Angioplasty Registry for all TS patients between 2015-2022. Gradient boosting was used to assess the relative importance of variables in predicting 30-day mortality in TS patients. Results Of the 3,180 hospitalized TS patients, 76% were women. The average age was 68.3 ± 11.2 years. The crude all-cause mortality rate was 2.57% at 30 days. The most important variable in predicting 30-day mortality was the hospital where the patient was treated, with a relative importance of 35.5%. This was followed by the clinical presentation for angiography (21.1%), creatinine level (11.9%), Killip class (8.9%), and age at angioplasty (6.5%). Other less important factors included weight, height, and certain medical conditions such as hyperlipidemia, smoking status, and hypertension. Gender and previous stroke history had a low impact on 30-day mortality in TS patients. Conclusions The treating hospital was the most important factor in predicting 30-day mortality in TS. Since the level of evidence for recommended treatments of TS is low, our findings highlight the importance of conducting randomized studies in this patient group to improve care.

Right ventricular myocardial work by echocardiography: non-invasive assessment of right ventricle function in patients with pulmonary hypertension

Abstract Background Right ventricular myocardial work (RVMW) assessed by transthoracic echocardiography allows to study and analyze the right ventricular (RV) function non-invasively, using RV pressure-strain loops. The association between these novel indexes of RVMW and invasive hemodynamic parameters has not yet been extensively studied, namely in precapillary pulmonary hypertension (PH) population. In right heart catheterization, stroke volume directly reflects right ventricular function in response to its load, and has prognostic implication in PH. Objectives To evaluate the relationship between RVMW and stroke volume index (SVi) measured invasively by right heart catheterization (RHC), in a cohort of patients with group I and group IV PH. Methods A prospective registry of pre-capillary PH patients evaluated in a single tertiary center was used. Echocardiography and RHC were performed in the same day. Dedicated software for left ventricle myocardial work was used for the RV. RV global myocardial work index (RVGWI) was calculated as the area of the RV pressure-strain loops. From RVGWI, RV global constructive work (RVGCW; work contributing to myocardial shortening during systole and lengthening during isovolumic relaxation), RV global wasted work (RVGWW; work contributing to myocardial lengthening during systole and shortening during isovolumic relaxation), and RV global work efficiency (RVGWE; relation between RVGCW and RVGWW) were estimated. Pearson’s correlation was applied to assess correlations between continuous variables. Results 17 pts (80% women, mean age 67 ± 10 years) were included. The average of mean pulmonary arterial pressure (mPAP) was 33 mmHg (± 9,5), of pulmonary vascular resistance (PVR) was 5,7 WU (± 5,1) and of SVi was 40,7 ml/m2 (± 10,8). Conventional echocardiographic parameters for the evaluation of RV systolic function, such as TAPSE, annular tricuspid s’ velocity and fractional area change (FAC), did not correlate with SVi. Moreover, right ventricle-pulmonary artery (RV-PA) coupling and RV GLS also did not correlate with this invasive parameter of right ventricle function. Of the RVMW indexes, RVGWW and RVGWE strongly correlated with SVi: as this invasive parameter decreases, RVGWW (r = -0,560, p = 0,019) increases significantly, whereas RVGWE (r= 0,539, p = 0,026) declines (Fig 1). In our population, RVGWI and RVGCW didn’t correlate significantly with SVi. Conclusions Finding non-invasive methods to evaluate RV function is essential in patients with RV hemodynamic overload, since conventional echocardiographic parameters do not perform well, and RV function is central in prognosis assessment in this population. Novel echocardiographic assessment of RVMW seems to provide a promising index of RV function in PH patients, as demonstrated with its correlation with SVi.Figure 1:Correlation of RVMW with SVi.