Nationwide Registry Research Articles

Comparing moderate-severe and severe mitral regurgitation in transcatheter aortic valve replacement on 1-year survival: insights from a Japanese Nationwide Registry.

This study aims to compare 1-year outcomes after transcatheter aortic valve replacement (TAVR) between patients with moderate-severe MR and severe MR preoperatively using the Japan Transcatheter Valve Therapy (J-TVT) registry. Patients undergoing TAVR for aortic stenosis between August 2013 and December 2019 with preoperative mitral regurgitation of moderate-severe (group MR3) or severe (group MR4) were included. Patients with a history of valve surgery and dialysis patients were excluded. A total of 2017 patients were included, and 1-year follow-up data were obtained from the registry (follow-up rate 98.5%). Propensity-score matching between MR3 and MR4 groups was performed. All-cause mortality and the composite outcome of death and/or heart failure events were compared. Crude data showed that 1-year survival was significantly higher in the MR 3 (89.8%) than MR 4 (84.7%) groups, and freedom from 1-year mortality and heart failure events was also higher in the MR 3 (87.1%) than MR 4 (80.5%) groups (p = 0.0001). After propensity-score matching, 452 cases (226 cases each in MR 3 group and MR 4 group) were extracted. Cox regression model showed no statistical difference in the 1-year survival rate between MR 3 group (84.5%) and MR 4 group (85.5%) (p = 0.84), nor in freedom from 1-year death and/or heart failure events between MR 3 group (80.2%) and MR 4 group (81.6%) (p = 0.72). The 1-year survival rate and freedom from death and/or heart failure events were found to be similar between patients undergoing TAVR with MR grade 3 and MR grade 4.

Pulsed-field ablation of atrial fibrillation with a pentaspline catheter across National Health Service England centres

IntroductionPulsed-field ablation (PFA) is a novel modality for pulmonary vein isolation in patients with atrial fibrillation (AF). We describe the initial uptake and experience of PFA using a pentaspline catheter...

A real-world study on the impact of infection load on mortality in multiple myeloma patients in Finland.

Infections are a clinically significant cause of mortality in multiple myeloma (MM) patients. The high number of infections in MM patients is due to the immunosuppressive effects of the disease itself as well as treatment-related immunosuppression. In this real-world evidence (RWE) study, we used several nationwide healthcare registries of Finland to investigate the effect of infection load on mortality in MM patients during 1997-2021. The highest number of infections was recorded during the first year after MM diagnosis. In patients who received allogenic or autologous stem cell transplantation (ASCT), the number of infections during the first two years post diagnosis was significantly higher than in those treated without ASCT. When compared to their age-, sex-, and region-matched controls, MM patients accrued more infections during the year prior to diagnosis. Intriguingly, patients under 70 years old had significantly more infections already 3 years before diagnosis when compared to their matched controls. Prior to MM diagnosis, the relative proportion of streptococcal septicaemia and pneumonia due to Streptococcus pneumoniae increased the most. Of note, even one recorded infection prior to diagnosis was associated with significantly shorter median overall survival. Importantly, Cox proportional hazard models show that recorded infections both before and after diagnosis increase the independent risk of mortality in MM patients.

Long-term rate of heart failure in patients with autoimmune disease: A nationwide cohort study.

Although certain autoimmune diseases (AIDs) have been associated with an increased rate of heart failure (HF), data on the long-term rate of HF across the spectrum of AIDs are lacking. We investigated the long-term rate of HF in individuals with a history of 28 different AIDs. Individuals diagnosed with an AID (2000-2021) were identified through Danish nationwide registries. Each patient with AID was matched with four individuals from the background population by age, sex, and year of inclusion. Multivariable Cox regression was used to compare the rate of HF between the AID and the background population, overall and according to individual AIDs. In total, 272 959 patients diagnosed with AID were matched with 1 091 836 individuals without AID (median age 55 years; 62% women; median follow-up 7.9 years). The 10-year cumulative incidence of HF was 5.2% for patients with AID and 3.5% for matched individuals. Patients with any AID had a higher associated rate of HF than matched individuals (hazard ratio [HR] 1.55, 95% confidence interval [CI] 1.52-1.59). Patients with each of the AIDs had a higher associated rate of incident HF compared with matched individuals from the background population, although the association was not statistically significant for Reiter's and Behcet's disease. The highest relative rates were observed in patients with systemic sclerosis (HR 3.31, 95% CI 2.63-4.16) and Addison's disease (HR 3.03, 95% CI 2.35-3.91). Patients with AID, irrespective of the type, had a higher associated rate of HF compared to the background population. Further research is needed to clarify whether screening for cardiovascular risk is beneficial.

Comparable outcomes among etiologies in early‐stage hepatocellular carcinoma: Analysis of a nationwide registry in Japan

AbstractAimTumor stage and liver function determine the prognosis of patients with hepatocellular carcinoma (HCC). However, prognosis may differ depending on etiology. This study aimed to investigate etiological differences in the prognosis of patients with HCC.MethodsWe enrolled patients initially diagnosed with HCC and curatively treated with resection or ablation between 2018 and 2021 from a Japanese nationwide registry. The patients were grouped into hepatitis B (HBV), hepatitis C (HCV), and non‐B, non‐C. Viral status was also assessed. The end‐points were overall survival and decompensation‐free survival. We applied inverse probability of treatment weighting to draw adjusted Kaplan–Meier curves.ResultsOf the 4568 patients, 3546 underwent resection and 1022 underwent ablation. Hepatitis B virus DNA was undetectable in 45.2% of patients with HBV, and a sustained virologic response was achieved in 42.7% of patients with HCV at the initial diagnosis of HCC. In the resection cohort (13.9% HBV, 29.4% HCV, and 56.0% non‐B, non‐C), the adjusted overall survival showed no significant difference between non‐B, non‐C versus HBV (p = 0.57, log‐rank test) and non‐B, non‐C versus HCV (p = 0.68). Decompensation‐free survival was also similar among etiologies. In the ablation cohort (11.1% HBV, 44.2% HCV, and 43.9% non‐B, non‐C), there was also no significant difference in adjusted survival among etiologies.ConclusionPrognosis of patients with HCC was similar among different etiologies after adjusting for tumor stage and liver function. Nearly half of the patients with viral hepatitis achieved viral suppression or eradication at the initial diagnosis of HCC in Japan.

Length of Hospital Stay for Endocarditis Before and After the Partial Oral Treatment of Endocarditis Trial

BackgroundThe results from the POET (Partial Oral Treatment of left-sided Endocarditis) trial were published in August 2018 and established noninferiority of oral step-down antibiotic treatment in stabilized patients with infective endocarditis (IE). Data on length of hospital stay (LOS) and safety following the POET trial are warranted. ObjectivesThe goal of this study was to examine changes in LOS and safety (mortality and relapse of bacteremia) before and after POET publication. MethodsUsing Danish nationwide registries, patients with first-time IE caused by Streptococcus spp., Enterococcus faecalis, Staphylococcus aureus, or coagulase-negative staphylococci from 2012 to 2021 were identified. Median LOS was examined according to publication date (before and after September 2018). Mortality and relapse of bacteremia at 180 days of follow-up were examined. ResultsWe identified 3,008 patients before POET publication (median age 72.8 years) and 1,740 after publication (median age 75.2 years) (P < 0.0001). The median LOS decreased by 8 days: 41 days (Q1-Q3: 29-49 days) before POET publication and 33 days (Q1-Q3: 21-44 days) after POET publication (P < 0.0001). Similar reductions in LOS were seen across microbiological etiologies and age groups. Reduction in LOS was most pronounced in nonsurgically treated patients. Mortality from IE admission to a maximum of 180 days’ follow-up was 27.5% before POET publication and 28.3% after publication (P = 0.41). The bacteremia relapse rate within 180 days was 3.5% before POET publication and 1.6% after publication (P = 0.0002). ConclusionsFollowing the POET trial, we found a reduction in median LOS of 8 days with no change in mortality and an associated lower rate of relapse of bacteremia.

Human papillomavirus-associated cancers, precancers, and genital warts in Denmark, 2000–2022 – Current burden of disease and population impact of multi-cohort HPV vaccination

ObjectivesWe present incidence trends of cancer and precancer at human papillomavirus(HPV)-associated sites, and genital warts, including the current burden of HPV-associated disease in Denmark, a country with multi-cohort HPV vaccination. MethodCases were identified from high-quality nationwide registries (2000−2022). The age-specific incidence rate, age-standardized incidence rate (ASR) and estimated annual percentage change (EAPC) were calculated according to sex and calendar year. The current burden (2020−2022) of HPV-associated disease was estimated as the average annual number of each lesion multiplied by the disease-specific HPV-attributable fraction. ResultsASRs of cervical precancer and genital warts declined markedly in the post-HPV vaccination period – for genital warts corresponding to an EAPC of −13.7 % (−15.0;-12.4)(women) and − 8.8 % (−9.4;-8.2)(men), respectively. ASRs of HPV-associated cancer sites increased continuously in men (EAPC:2.8 %(2.2;3.5)), and the same was observed for non-cervical HPV-associated cancer sites in women (EAPC:2.5 %(2.0;3.0)). Cervical cancer, however, decreased in the post-HPV vaccination period (EAPC:-2.7 %(−3.8;-1.5)). Age-specific incidence rates of HPV-associated cancer sites decreased slightly in younger women and were stable in younger men, while incidence rates in older men approached or even surpassed that of older women. Data on the current burden showed that cervical precancer and genital warts are still the major contributors to HPV-associated disease, and oropharyngeal cancer now accounts for more annual cases on a population level than cervical cancer. ConclusionDanish data show decreased incidence of cervical lesions and genital warts in the post-vaccine era. Despite population impact of HPV vaccination, HPV-associated disease remains a public health issue and increasingly among men.

Characteristics, outcomes, and prognostic factors in patients with hanging-induced out-of-hospital cardiac arrest: An analysis of a nationwide registry in Japan

AimTo investigate the characteristics, outcomes, and prognostic factors of patients with hanging-induced out-of-hospital cardiac arrest (OHCA). MethodsWe analysed data from a population-based Japanese nationwide OHCA registry (2021–2022), comparing patients aged ≥18 years with hanging-induced OHCA to those with other OHCA causes. The primary outcome was 1-month favourable neurological outcomes. Prognostic factors for hanging-induced OHCA were identified using multivariable logistic regression analysis. ResultsOf 263,426 OHCAs, 7,878 (3.0 %) were hanging-induced, with an incidence of 3.1 per 100,000 person-years. Patients with hanging-induced OHCA were younger (median age; 58 vs. 81 years), more frequently males (60.2 % vs. 57.5 %), and less likely to have a witness (1.7 % vs. 42.1 %) and initial shockable rhythm (0.4 % vs. 5.9 %). The chance of 1-month favourable neurological outcomes was significantly lower in patients with hanging-induced OHCA than those with other OHCA causes (0.4 % vs. 2.5 %). Factors associated with favourable neurological outcomes included younger age, witnessed arrest, initial non-asystole cardiac rhythm, and prehospital return of spontaneous circulation (ROSC). Patients with initial non-asystole rhythm and prehospital ROSC had an 11.1 % probability of favourable neurological outcomes, whereas 97.1 % of patients lacking these characteristics had only a 0.1 % probability. ConclusionsPrognosis following hanging-induced OHCAs was significantly worse compared to OHCAs of other causes. While some patients with initial non-asystole rhythm and prehospital ROSC may benefit from cardiopulmonary resuscitation, most lack these favourable features and have an exceedingly low chance of achieving favourable neurological outcomes at 1-month post-arrest.

Nationwide Survey of Multisystem Inflammatory Syndrome in Children Associated with Coronavirus Disease 2019 in Japan.

Multisystem inflammatory syndrome in children (MIS-C) presents some clinical overlap with Kawasaki disease (KD). Although KD is common in Japan, the clinical characteristics of MIS-C in Japan remain unknown. Therefore, we aimed to determine the epidemiological and clinical features of MIS-C in Japan. Using a case reporting form, a nationwide registry was created between November 2020 and March 2023, involving 2,080 facilities throughout Japan. We prospectively and retrospectively enrolled patients with MIS-C. The primary outcomes were the number and incidence rates of children with MIS-C. The secondary outcomes included clinical features, such as KD phenotype, organ involvement, shock, intensive care unit admission, and coronary artery lesions. Among 398 patients registered, central review identified 129 MIS-C cases (mean age: 8·8 ± 3·7years). The overall incidence rate was estimated to be 1·5 per 100,000 COVID-19 cases, exhibiting a decline as the COVID-19 pandemic progressed, from 12·3 cases (Pre-Delta) to 1·3 cases (Omicron); 80% of MIS-C cases occurred during the Omicron variant predominant period, and 72% of children with MIS-C met the KD criteria. Cardiovascular (88%) and gastrointestinal (90%) involvement were frequent. In Japan, MIS-C cases showed comparatively less severe clinical features, with shock in 29% and admission to the intensive care unit in 12% of cases. Coronary artery lesions were identified in 15 cases (11·6%), irrespective of the presence of shock. No fatalities were reported. The incidence of MIS-C was low in Japan. The clinical features distinctively exhibited a more KD-like phenotype, with less severe clinical features.

Contemporary diagnosis and treatment of valvular heart disease in Korea: a nationwide hospital-based registry study

BackgroundThis study was designed to determine the current status of diagnosis and treatment of valvular heart disease (VHD) in Korea.MethodsA nationwide registry study was conducted in 45 hospitals in Korea involving adult patients with at least moderate VHD as determined by echocardiography carried out between September and October of 2019. Of a total of 4,094 patients with at least moderate VHD, 1,482 had severe VHD (age, 71.3 ± 13.5 years; 49.1% male). Echocardiographic data used for the diagnosis of each case of VHD were analyzed. Experts from each center determined the diagnosis and treatment strategy for VHD based on current guidelines and institutional policy. The clinical outcome was in-hospital mortality.ResultsEach valve underwent surgical or transcatheter intervention in 19.3% cases of severe mitral stenosis, 31.4% cases of severe primary mitral regurgitation (MR), 7.5% cases of severe secondary MR, 43.7% cases of severe aortic stenosis, 27.5% cases of severe aortic regurgitation, and 7.2% cases of severe tricuspid regurgitation. The overall in-hospital mortality rate for patients with severe VHD was 5.4%, and for secondary severe MR and severe tricuspid regurgitation, the rates were 9.0% and 7.5%, respectively, indicating a poor prognosis. In-hospital mortality occurred in 73 of the 1,244 patients (5.9%) who received conservative treatment and in 18 of the 455 patients (4.0%) who received a surgical or transcatheter intervention, which was significantly lower in the intervention group (P = 0.037).ConclusionsThis study provides important information about the current status of VHD diagnosis and treatment through a nationwide registry in Korea and helps to define future changes.

The Current Status of Endovascular Treatment for Extracranial Vertebral Artery Stenosis in Japan: A Subanalysis of the Japanese Registry of Neuroendovascular Therapy 4.

Endovascular treatment (EVT) is a potential therapeutic option for extracranial vertebral artery (VA) stenosis; however, its efficacy or optimal procedures remain unknown. This study aimed to investigate the recent status of EVT for extracranial VA stenosis in Japan using a nationwide registry. We conducted a post hoc analysis of the Japanese Registry of Neuroendovascular Therapy 4 that enrolled patients who underwent EVT at 166 hospitals in Japan from 2015 to 2019. The outcomes of this study were as follows: procedural success indicating that the planned procedure was completed, modified Rankin Scale (mRS) score at 30 days, and procedure-related complications evaluated according to the procedure during EVT (percutaneous transluminal angioplasty vs. stenting and with or without the use of embolic protection devices [EPDs]). Of 308 eligible patients, 301 (95%) were treated for atherosclerotic stenosis, predominantly by stenting (74%). EPDs were used in 43%, primarily with the distal balloon (63%). The proportion of procedural success was 98%. Functional independence (mRS of 0-2) at 30 days was achieved in 80% of the total cohort, and there were no differences between patients treated with or without stenting or EPDs (74% vs. 82%, p = 0.12, and 80% vs. 80%, p = 0.93). Procedural complications occurred in 28 (9.1%) patients similarly in each group, with distal embolism and vessel dissection being common. In conclusion, EVT is a reasonable option for extracranial VA stenosis as a daily clinical practice. This study emphasizes the potential of EVT in managing extracranial VA stenosis and the need for further research to refine treatment strategies.

Management of venous aneurysms and the vascular surgical treatment options : Selection of representative case constellations illustrating experiences at acenter for vascular surgery

Venous aneurysms are arare entity in vascular surgery, which are mostly described in individual case series and meta-analyses generated from them. The treatment concepts are diverse and surgical treatment is highlighted due to the risk of thrombosis and pulmonary embolism. There is still an ongoing debate regarding the postoperative necessity and duration of anticoagulation. Case series of aconsecutive patient cohort with venous aneurysms from the last 18years in acenter of (highly specialized care) vascular surgery including i)own experiences obtained in daily vascular surgical practice and ii)aselected and current literature search of relevant references on possible and, in particular, established diagnosis-specific therapeutic concepts. Between 2005 and 2023, atotal of 11cases of venous aneurysms were reported in patients aged 30-84years (mean: 52.5, median: 50), with 1 patient requiring surgery for a recurrence after 2years. The gender ratio was 7:3 (m:f) and the popliteal vein was the most frequently affected anatomical region with 36.4%, followed by the internal jugular vein and axillary/subclavian vein each with 18.2%. Aneurysms of the inferior vena cava, the common iliac vein and the cubital vein occurred only once. Surgical treatment of the aneurysms was performed in 9cases. The surgical methods used were i)tangential resection of the aneurysm wall and continuous purse-string suture, ii)resection of the aneurysm and interposition of an 8‑mm GORE-TEX® vascular graft prosthesis (Gore, Putzbrunn, Germany), iii)ligation of the aneurysm and iv)ligation with subsequent resection of the aneurysm. The rarity of venous aneurysms should be a reason to register these cases centrally (possibly, nationwide diagnosis-related register). Surgical treatment is usually unproblematic and associated with few complications. The risk of pulmonary embolism appears to be significantly increased in venous aneurysms of the extremities, pelvic veins and inferior vena cava, while venous aneurysms of the head and neck are significantly less prone to this. Perioperative and postoperative anticoagulation has been adapted to the development of specific anticoagulants and novel drugs, in favor of treatment with direct oral anticoagulants (DOAC). In personal experience, immediate postoperative heparin perfusion (low dose) and subsequent therapeutic bridging with low-molecular-weight heparin before switching to an anticoagulant for outpatient clinic-based care appears to safeguard the perioperative phase with respect to keeping the surgery-related complication rate (e.g., thrombosis, bleeding) low.

Educational inequalities in mental health expectancy. Analysis based on registry data and survey data from the Danish National Health Survey.

Social inequality in life expectancy (LE) and various indicators of health expectancy have received much attention. Mental health expectancy (MHE) has received less attention, although research has shown an increasing prevalence of poor mental health. We aimed to investigate educational differentials in LE in relation to good, moderate, and poor mental health. Nationwide registry data on education and mortality were linked and combined with data from the Danish National Health Survey for 2017 and 2021 on mental health and education. The sample group consisted of data on Danes aged 30 and over. MHE was estimated by Sullivan's method. From 2017 to 2021, a general decline in the MHE of Danes was observed. Furthermore, the educational inequality in MHE remained substantial between genders, and was larger than the inequality in LE. Changes in MHE differed across educational groups. For Danes with short education, good MHE tended to increase for men, while the increase was statistically significant among women. MHE is associated with educational attainment. Despite the observed changes in educational differential, substantial inequality persists, raising important questions about the underlying causes of social disparity in MHE.

First Trimester Tetracycline Exposure and Risk of Major Congenital Malformations

Safety data on tetracycline antibiotic use during pregnancy are limited. To investigate the association between first trimester exposure to tetracyclines and the risk of major congenital malformations (MCMs). This cohort study used data from nationwide registers for singleton infants live-born in Sweden from July 1, 2006, to December 31, 2018, with follow-up through December 2019. Tetracycline-exposed and unexposed infants were matched on propensity scores (ratio 1:10). Data analysis was performed from June 2023 to May 2024. First trimester exposure to tetracyclines determined from maternal prescription fills, compared with no exposure. The primary outcome was any MCM diagnosed in the first year of life; secondary outcomes were 12 major malformation organ system subgroups and 16 individual malformations selected on the basis of prior safety signals and/or fulfillment of prespecified statistical power criteria. Malformations were identified by International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) codes aligned to the European Surveillance of Congenital Anomalies (EUROCAT) classification. Log binomial regression was used to estimate relative risks (RRs) with 95% CIs. From a source cohort of 1 245 889 eligible infants (640 892 male [51.4%]), a propensity score-matched analytical cohort of 69 656 infants (35 903 male [51.5%]) was generated. Of 6340 infants exposed to tetracyclines during the first trimester (3325 male [52.4%]), 252 received a diagnosis of any MCM (39.75 cases per 1000 infants; 95% CI, 35.14-44.93 cases per 1000 infants) compared with 2454 of 63 316 unexposed infants (38.76 cases per 1000 infants; 95% CI, 37.27-40.30 cases per 1000 infants). Tetracycline exposure was not associated with any MCM (RR, 1.03; 95% CI, 0.90-1.16). The RRs for specific tetracycline substances were 1.07 (95% CI, 0.93-1.23) for doxycycline, 0.83 (95% CI, 0.60-1.15) for lymecycline, and 0.78 (95% CI, 0.32-1.92) for tetracycline-oxytetracycline. There was no increased risk for 10 of 12 malformation subgroups or for any of the 16 individual malformations analyzed. The higher RRs in the main analysis for nervous system anomalies (1.92; 95% CI, 0.98-3.78) and eye anomalies (1.76; 95% CI, 1.07-2.91) were attenuated in a sensitivity analysis with follow-up extended to age 3 years (nervous system anomalies, RR, 1.08; 95% CI, 0.52-2.24; eye anomalies, RR, 1.42; 95% CI, 0.88-2.29). In this cohort study, first trimester tetracycline exposure was not associated with increased risks of any MCMs. Additional studies are needed to rule out potential risks owing to power limitations for several MCM subgroups and individual malformations.

Abstract 4144555: Atrial Fibrillation Catheter Ablation among Patients with Mediastinal Radiation; Insight from The National Inpatient Database (2015-2020)

Introduction/Background: Radiation therapy (RT) is one of the most common treatment modalities for mediastinal cancers. RT has multiple adverse cardiovascular effects and it has been identified as an independent risk factor for atrial fibrillation (AF). The efficacy of catheter ablation in AF is well established, however there is limited data on procedural safety and outcomes in patients with mediastinal cancers and history of radiation Methods: The National Inpatient Sample (NIS) was analyzed from 2015-2020 to identify admissions for AF catheter ablation among patients with previous history of mediastinal radiation exposure using the 10-PCS (International Classification of Diseases, procedure coding system) codes. Baseline characteristics were compared between the two groups and multivariate logistic regression was used to analyze hospitalization outcomes. Results: We identified 257,240 admissions for AF catheter ablation of which 1720 patients (0.67%) had a history of mediastinal radiation exposure. In the adjusted analysis, the odds of in-hospital mortality (aOR 0.639, 95% CI 0.34-1.20, p 0.1637), major complications (aOR 0.876, 95% CI 0.73-1.05, p 0.1443), any gastrointestinal or hematological complication (aOR 0.853, 95% CI 0.63-1.15, p 0.3017), renal complications (aOR 1.017, 95% CI 0.88-1.18, p 0.0509) were similar in both cohorts. The odds of any cardiovascular complication (aOR 0.825, 95% CI 0.70-0.97, p 0.0208) was lower and odds of any pulmonary complication (aOR 1.433, 95% CI 1.27-1.62, p&lt;.001) was higher in the mediastinal radiation cohort. Conclusion: AF catheter ablation in patients with history of mediastinal radiation is a safe treatment modality. It is not associated with higher in-hospital mortality or cardiac complications in a nationwide registry.

Long-term risk of heart failure in patients with postoperative atrial fibrillation following non-cardiac surgery: Insights from a nationwide cohort.

Atrial fibrillation (AF) is associated with heart failure (HF). However, it is unclear if postoperative AF (POAF) following non-cardiac surgery differs from non-surgical AF in terms of the risk of HF. We compared the long-term rate of incident HF in patients developing new-onset POAF following non-cardiac surgery with patients who did not develop POAF following non-cardiac surgery and patients with non-surgical non-valvular AF (NVAF). Using Danish nationwide registries, all patients aged ≥30 years who developed POAF following non-cardiac surgery (1996-2020) were identified and matched in a 1:3 ratio by age, sex, surgery type (only for the surgery group), selected comorbidities, and inclusion year with patients without POAF following non-cardiac surgery and individuals with NVAF, respectively. A total of 2270 patients with POAF were matched with 6810 patients without POAF following non-cardiac surgery, and 1846 patients with POAF were matched with 5538 patients with NVAF. The median follow-up was 7.2 years. Compared with patients without POAF, those with POAF had a higher associated long-term rate of incident HF (2.6 vs. 1.2 events per 100 person-years; adjusted hazard ratio [HR] 2.39, 95% confidence interval [CI] 2.06-2.78). Compared with individuals with NVAF, patients with POAF did not have a significantly different rate of incident HF (2.7 vs. 3.0 events per 100 person-years; adjusted HR 0.89, 95% CI 0.78-1.03). Patients with new-onset POAF following non-cardiac surgery had a higher associated long-term rate of incident HF compared to those without POAF, with no significant difference in the rate of incident HF when compared to patients with NVAF.

Abstract 4119094: Claims-Based versus Registry-Reported Stroke Events in the NCDR Left Atrial Appendage Occlusion Registry

Background: Administrative claims data are increasingly used for post-marketing surveillance of drugs and medical devices, though data reliability remains uncertain. Given their associated morbidity and mortality, stroke events are particularly important to monitor for cardiovascular therapies such as transcatheter left atrial appendage occlusion (LAAO). However, there are limited data comparing stroke events in contemporary claims data to events reported in large nationwide registries with comprehensive data collection. Aim: To compare stroke events in Medicare claims data with adjudicated registry-reported events in the National Cardiovascular Data Registry Left Atrial Appendage Occlusion (LAAO) Registry. Methods: LAAO Registry data were linked with 2016-2022 Medicare inpatient claims. Primary diagnosis ICD-10 codes from inpatient hospitalizations were compared to adjudicated registry-reported ischemic and hemorrhagic stroke events occurring after discharge with up to two years of follow-up. In multiple secondary analyses, primary and secondary diagnosis codes were counted as events in claims data and patients with prior history of stroke were also excluded. Results: The cohort included 71,043 adults ≥65 years old in the LAAO Registry with inpatient Medicare data. Following LAAO hospitalization discharge, there were 1405 claims-based and 1308 registry-reported total stroke events. Sensitivity and positive predictive value (PPV) of claims for identifying registry-reported events were 60.8% and 50.5% for ischemic stroke (kappa statistic 0.55), 42.7% and 50.5% for hemorrhagic stroke (kappa 0.46), and 58.1% and 54.1% for all stroke (kappa 0.55), respectively. Inclusion of secondary diagnosis codes improved sensitivity of claims (70.3% for ischemic stroke, 53.9% for hemorrhagic stroke and 67.0% for all stroke), but PPV decreased (44.8% for ischemic stroke, 34.8% for hemorrhagic stroke and 47.8% for all stroke). Specificity and negative predictive values of claims data were &gt;98% for all stroke types. Findings were similar after excluding patients with prior history of stroke ( Table ). Conclusions: Among Medicare patients in the LAAO Registry, administrative claims data had moderate agreement with adjudicated registry-reported stroke events. Claims data may not reliably capture all stroke events in real-world practice, and additional event ascertainment methods may be needed to ensure accurate assessment of stroke in post-marketing surveillance efforts.

Outcomes of Older Patients With Cardiogenic Shock Using the Impella Device - Insights From the Japanese Registry for Percutaneous Ventricular Assist Device (J-PVAD).

Aging has progressed in several regions of the world with more older patients experiencing acute cardiovascular disease. Impella is a percutaneous potent circulatory support device associated with substantial cost and potential device-related complications. We analyzed the Japanese nationwide registry, encompassing consecutive patients with cardiogenic shock using Impella. Among 5,718 patients treated between 2020 and 2022, we compared older patients (≥75 years) with younger patients. The primary outcome was the Kaplan-Meier estimated 30-day mortality, and the secondary outcome was Impella-related complications. The median age of the 5,718 patients was 69 (58-77) years, and 1,807 (31.6%) were older, with smaller body mass index, frequent acute coronary syndrome, and infrequent myocarditis. Comorbidities were frequently observed in older patients with a higher ejection fraction and less frequency of extracorporeal membrane oxygenation. Older patients had a higher 30-day mortality than younger patients (38.9% vs. 32.5%; P<0.0001). The 30-day mortality was statistically equivalent among older subsets (75-79 vs. 80-84 vs. ≥85 years). Device-related complications similarly occurred similarly among the older subsets, except for a modest increase in cardiac tamponade and limb ischemia. Older age, body mass index, myocarditis, prior arrhythmia, shock severity, renal and hepatic impairment, and limb ischemia were associated with 30-day mortality. The selected older patients using Impella exhibited modestly higher 30-day mortality with similar safety profiles. A longer follow up and optimal patient selection are important.

Racing against time: Emergency ambulance dispatches and response times, a register-based study in Region Zealand, Denmark, 2013-2022.

The global strain on Emergency Medical Services (EMS) is reflected in the increasing number of emergency ambulance dispatches. Shorter EMS response times have demonstrated some effect on very specific and rare conditions. It is unknown if the increased number of ambulance dispatches compromises response times. This study aimed to describe trends in emergency ambulance dispatches and response times from 2013 to 2022 in Region Zealand, Denmark. Additionally, it aimed to outline the demographic profile of emergency ambulance patients, including age and comorbidities. Using administrative data from the Region Zealand emergency medical dispatch center, a register-based study spanning from January 1, 2013, to December 31, 2022, was conducted. Data were linked with nationwide registries and priority A (emergency), or B (urgent) ambulance dispatches were included. Trends were examined overall and stratified by catchment areas corresponding to the hospitals with emergency departments in the region. Poisson and ordinal logistic regressions were used to analyze data. The study encompassed 678,789 emergency ambulance dispatches, with 55.0% priority A and 45.0% priority B. Among these, 667,788 had a valid personal identification number allowing for further analysis. Within the study population, females comprised 48.5%, while 49.1% of patients were 65years or more. Overall, 47.5% of patients had no comorbidities, while 7.7% and 44.8% had mild and severe comorbidities, respectively. Emergency ambulance dispatches increased from 56,867 in 2013 to 81,080 in 2022 (143%). Correspondingly, the dispatch incidence rate per 1,000 residents per year increased from 69.2 to 95.5. Stratification by catchment areas revealed significant disparities. The median response time for priority A dispatches increased from 7min:14s in 2013 to 8min:20s in 2022 and for priority B dispatches from 12min:23s to 15min:6s. From 2013 to 2022, emergency ambulance dispatches both priorities A and B increased in absolute numbers and per 1000 residents per year. Ambulance response times also increased for both priorities during the study period. The study shows regional disparities regarding to the rate of emergency ambulance dispatches and response times indicating challenges in resource distribution in the future for maintaining emergency care standards.

Care Quality and Outcomes of Ischemic Stroke in Patients With Premorbid Dementia: Get With The Guidelines-Stroke Registry.

Patients with premorbid dementia have been generally excluded from trials of stroke therapies, and their dementia diagnosis may affect the care received. There are few data on the quality of stroke care and outcomes in these patients. We compared the quality of care and outcomes for acute ischemic stroke patients with versus without premorbid dementia using national data from the Get With The Guidelines-Stroke registry between July 1, 2020, and December 31, 2021. Process outcomes included receiving intravenous thrombolysis, endovascular thrombectomy, and additional national quality measures. Clinical outcomes included ambulatory status at discharge, discharge destination, and mortality. The analyses were adjusted for patient and hospital characteristics. Among 609 350 patients with acute ischemic stroke, 29 751 of 546 407 (5.4%) had documented prestroke dementia (median age, 84 [interquartile range, 78-89]; 62.8% female). Patients with versus without premorbid dementia were more likely to arrive via emergency medical services (70.5% versus 46.8%) and had more severe strokes (median National Institutes of Health Stroke Scale score, 7 [interquartile range, 3-15] versus 3 [interquartile range, 1-8]). They were less likely to be admitted to a comprehensive stroke center (17.9% versus 22.7%; P<0.0001), to receive intravenous thrombolysis (9.6% versus 11.1%; adjusted odds ratio [aOR], 0.91 [95% CI, 0.87-0.95]) or endovascular thrombectomy (4.5% versus 7.4%; aOR, 0.62 [95% CI, 0.56-0.68]), attain each of the Get With The Guidelines-Stroke Achievement Measures and Quality Measures, or attain defect-free stroke care (92.0% versus 95.0%; aOR, 0.75 [95% CI, 0.71-0.78]). Patients with premorbid dementia had longer door-to-needle times (adjusted difference, 3.17 minutes [95% CI, 1.34-5.01]), lower odds of being discharged home (43.8% versus 60.1%; aOR, 0.96 [95% CI, 0.93-1.00]), and higher odds of being nonambulatory at discharge (25.8% versus 9.3%; aOR, 1.62 [95% CI, 1.54-1.69]), and of in-hospital mortality or hospice admission (23.3% versus 8.6%; aOR, 1.38 [95% CI, 1.32-1.43]). Symptomatic intracranial hemorrhage after intravenous thrombolysis/endovascular thrombectomy did not differ (5.3% versus 3.7%; aOR, 1.13 [95% CI, 0.97-1.31]). Patients with premorbid dementia experienced slightly poorer quality of stroke care across multiple measures, were less likely to receive acute stroke interventions, and had worse poststroke outcomes than patients without dementia in a large nationwide registry. Our findings underscore the need for concerted efforts to further improve care quality and outcomes in this population.