Incidence and predictors of thermal oesophageal and vagus nerve injuries in Ablation Index-guided high-power-short-duration ablation of atrial fibrillation: a prospective study.

AIMS: High-power-short-duration (HPSD) ablation is an effective treatment for atrial fibrillation but poses risks of thermal injuries to the oesophagus and vagus nerve. This study aims to investigate incidence and predictors of thermal injuries, employing machine learning. METHODS AND RESULTS: A prospective observational study was conducted at Leipzig Heart Centre, Germany, excluding patients with multiple prior ablations. All patients received Ablation Index-guided HPSD ablation and subsequent oesophagogastroduodenoscopy. A machine learning algorithm categorized ablation points by atrial location and analysed ablation data, including Ablation Index, focusing on the posterior wall. The study is registered in clinicaltrials.gov (NCT05709756). Between February 2021 and August 2023, 238 patients were enrolled, of whom 18 (7.6%; nine oesophagus, eight vagus nerve, one both) developed thermal injuries, including eight oesophageal erythemata, two ulcers, and no fistula. Higher mean force (15.8 ± 3.9 g vs. 13.6 ± 3.9 g, P = 0.022), ablation point quantity (61.50 ± 20.45 vs. 48.16 ± 19.60, P = 0.007), and total and maximum Ablation Index (24 114 ± 8765 vs. 18 894 ± 7863, P = 0.008; 499 ± 95 vs. 473 ± 44, P = 0.04, respectively) at the posterior wall, but not oesophagus location, correlated significantly with thermal injury occurrence. Patients with thermal injuries had significantly lower distances between left atrium and oesophagus (3.0 ± 1.5 mm vs. 4.4 ± 2.1 mm, P = 0.012) and smaller atrial surface areas (24.9 ± 6.5 cm2 vs. 29.5 ± 7.5 cm2, P = 0.032). CONCLUSION: The low thermal lesion's rate (7.6%) during Ablation Index-guided HPSD ablation for atrial fibrillation is noteworthy. Machine learning based ablation data analysis identified several potential predictors of thermal injuries. The correlation between machine learning output and injury development suggests the potential for a clinical tool to enhance procedural safety.

Impact of repeat ablation of ventricular tachycardia in patients with structural heart disease.

AIMS: Recurrences of ventricular tachycardia (VT) after initial catheter ablation is a significant clinical problem. In this study, we report the efficacy and risks of repeat VT ablation in patients with structural heart disease (SHD) in a tertiary single centre over a 7-year period. METHODS AND RESULTS: Two hundred ten consecutive patients referred for repeat VT ablation after previous ablation in our institution were included in the analysis (53% ischaemic cardiomyopathy, 91% males, median age 65 years, mean left ventricular ejection fraction 35%). After performing repeat ablation, the clinical VTs were acutely eliminated in 82% of the patients, but 46% of the cohort presented with VT recurrence during the 25-month follow-up. Repeat ablation led to a 73% reduction of shock burden in the first year and 61% reduction until the end of follow-up. Similarly, VT burden was reduced 55% in the first year and 36% until the end of the study. Fifty-two patients (25%) reached the combined endpoint of ventricular assist device implantation, heart transplantation, or death. Advanced New York Heart Association functional class, anteroseptal substrate, and periprocedural complication after repeat ablation were associated with worse prognosis independently of the type of cardiomyopathy. CONCLUSION: While complete freedom from VT after repeat ablation in SHD was difficult to achieve, ablation led to a significant reduction in VT and shock burden. Besides advanced heart failure characteristics, anteroseptal substrate and periprocedural complications predicted a worse outcome.

Single catheter approach for treatment of premature ventricular contractions.

BACKGROUND: Catheter ablation has become one of the main treatment strategies in patients with premature ventricular complexes (PVC). The successful mapping and ablation can be performed with an ablation catheter without additional diagnostic catheters. HYPOTHESIS: We hypothesize that using a single catheter for PVC ablation may decrease complications, procedure time, and fluoroscopy exposure while maintaining comparable success rates. METHODS: Sixty-nine consecutive patients with PVC were treated with a single catheter approach compared to a historical cohort, in which a conventional setup was used. Propensity score matching was conducted with a 1:1 ratio. Outcome parameters included acute procedural success with elimination of all premature ventricular contractions after catheter ablation, procedural data as well as complication rates. RESULTS: Patients treated with a single catheter approach had shorter total procedure (60 minutes [IQR: 47,5-69,0 minutes] vs. 90 minutes [IQR 60-120 minutes]; p = 0.001) and fluoroscopy times (218 seconds [IQR: 110,5-446 seconds] vs. 310 seconds [IQR 190-640 seconds]; p = 0.012), which consecutively leads to a reduction of radiation exposure signified by a lower dose area product (155 cGycm² [IQR 74.4-334.5 cGycm²] vs. 368.4 cGycm² [IQR: 126-905.4 cGycm²]; p value 0.009). Acute procedural success rates were comparable in both groups (54 [84.3%] in the single catheter approach group and 58 [90.6%] in the conventional group; p: 0.287). CONCLUSION: A single catheter approach for the treatment of PVC is associated with a reduction of procedure- and fluoroscopy time, as well as a lesser radiation exposure, while maintaining equivalent acute success and complication rates compared with a conventionally used catheter setup.

Artificial intelligence-based identification of left ventricular systolic dysfunction from 12-lead electrocardiograms: external validation and advanced application of an existing model.

Aims: The diagnostic application of artificial intelligence (AI)-based models to detect cardiovascular diseases from electrocardiograms (ECGs) evolves, and promising results were reported. However, external validation is not available for all published algorithms. The aim of this study was to validate an existing algorithm for the detection of left ventricular systolic dysfunction (LVSD) from 12-lead ECGs. Methods and results: Patients with digitalized data pairs of 12-lead ECGs and echocardiography (at intervals of ≤7 days) were retrospectively selected from the Heart Center Leipzig ECG and electronic medical records databases. A previously developed AI-based model was applied to ECGs and calculated probabilities for LVSD. The area under the receiver operating characteristic curve (AUROC) was computed overall and in cohorts stratified for baseline and ECG characteristics. Repeated echocardiography studies recorded ≥3 months after index diagnostics were used for follow-up (FU) analysis. At baseline, 42 291 ECG-echocardiography pairs were analysed, and AUROC for LVSD detection was 0.88. Sensitivity and specificity were 82% and 77% for the optimal LVSD probability cut-off based on Youden's J. AUROCs were lower in ECG subgroups with tachycardia, atrial fibrillation, and wide QRS complexes. In patients without LVSD at baseline and available FU, model-generated high probability for LVSD was associated with a four-fold increased risk of developing LVSD during FU. Conclusion: We provide the external validation of an existing AI-based ECG-analysing model for the detection of LVSD with robust performance metrics. The association of false positive LVSD screenings at baseline with a deterioration of ventricular function during FU deserves a further evaluation in prospective trials.

Corrigendum: Case Report: Four cases of cardiac sarcoidosis in patients with inherited cardiomyopathy-a phenotypic overlap, co-existence of two rare cardiomyopathies or a second-hit disease.

[This corrects the article DOI: 10.3389/fcvm.2023.1328802.].

A Comparison of Different Intensive Care Unit Definitions Derived from the German Administrative Data Set: A Methodological, Real-World Data Analysis from 86 Helios Hospitals.

Background: The intensive care unit (ICU) is a scarce resource in all health care systems, necessitating a well-defined utilization. Therefore, benchmarks are essential; and yet, they are limited due to heterogenous definitions of what an ICU is. This study analyzed the case distribution, patient characteristics, and hospital course and outcomes of 6,204,093 patients in the German Helios Hospital Group according to 10 derived ICU definitions. We aimed to set a baseline for the development of a nationwide, uniform ICU definition. Methods: We analyzed ten different ICU definitions: seven derived from the German administrative data set of claims data according to the German Hospital Remuneration Act, three definitions were taken from the Helios Hospital Group's own bed classification. For each ICU definition, the size of the respective ICU population was analyzed. Due to similar patient characteristics for all ten definitions, we selected three indicator definitions to additionally test statistically against IQM. Results: We analyzed a total of 5,980,702 completed hospital cases, out of which 913,402 referred to an ICU criterion (14.7% of all cases). A key finding is the significant variability in ICU population size, depending on definitions. The most restrictive definition of only mechanical ventilation (DOV definition) resulted in 111,966 (1.9%) cases; mechanical ventilation plus typical intensive care procedure codes (IQM definition) resulted in 210,147 (3.5%) cases; defining each single bed individually as ICU or IMC (ICUá´§IMC definition) resulted in 411,681 (6.9%) cases; and defining any coded length of stay at ICU (LOSi definition) resulted in 721,293 (12.1%) cases. Further testing results for indicator definitions are reported. Conclusions: The size of the population, utilization rates, outcomes, and capacity assumptions clearly depend on the definition of ICU. Therefore, the underlying ICU definition should be stated when making any comparisons. From previous studies, we anticipated that 25-30% of all ICU patients should be mechanically ventilated, and therefore, we conclude that the ICUá´§IMC definition is the most plausible approximation. We suggest a mandatory application of a clearly defined ICU term for all hospitals nationwide for improved benchmarking and data analysis.

Timely cholecystectomy: important factors to improve guideline adherence and patient treatment.

OBJECTIVE: Cholecystectomy is one of the most frequently performed surgeries in Germany and is performed as a treatment of acute cholecystitis (guideline S3 IIIB.8) and after endoscopic retrograde cholangiopancreatography for choledocholithiasis with simultaneous cholecystolithiasis (guideline S3 IIIC.6). This article examines the effects of a guideline update from 2017, which recommends prompt cholecystectomy within 24 hours of admission due to cholecystitis or within 72 hours after bile duct repair. In addition, it aims to identify reasons (eg, financial disincentives) and potential for improvement for non-adherence to the guidelines. DESIGN: Methodologically, a retrospective analysis based on routine billing data from 84 Helios Group hospitals from 2016 and 2022, with a total of 45 393 included cases, was applied. The guideline adherence rate is used as the main outcome measure. RESULTS: Results show the guideline updates led to a statistically significant increase in the proportion of cholecystectomy performed in a timely manner (guideline S3 IIIB.8: increase from 43% to 49%, p<0.001; guideline S3 IIIC.6: increase from 7% to 20%, p<0.001). Medical, structural and financial reasons for non-adherence could be identified. CONCLUSION: As possible reasons for non-adherence, medical factors such as advanced age, multimorbidity and frailty could be identified. Analyses of structural factors revealed that hospitals in very rural regions are less likely to perform timely cholecystectomies, presumably due to infrastructural and personnel-capacity bottlenecks. A similar picture emerges for maximum-care hospitals, which might be explained by more severe and complex cases on average. Further evaluation indicates that an increase in and better hospital-internal participation of gastroenterologists in remuneration could lead to even greater adherence to the S3 IIIC.6 guideline.

Characteristics and outcome of hospitalized patients with heart failure stratified for chronic kidney disease.

AIMS: Heart failure (HF) and chronic kidney disease (CKD) place significant challenges on the healthcare system, and their co-existence is associated with shared adverse outcomes. The multinational CaReMe project was initiated to provide contemporary, real-world epidemiological data on cardiovascular and reno-metabolic diseases. Utilizing data from the German CaReMe cohort, we characterize a multicentric HF population and describe in-hospital outcomes stratified for co-morbid CKD. METHODS AND RESULTS: This retrospective, observational study analysed administrative data from inpatient cases hospitalized in 87 German Helios hospitals between 1 January 2016 and 31 August 2022. The first hospitalization of patients aged ≥18 years with a primary discharge diagnosis of HF, based on ICD-10 codes, were considered the index cases, and subsequent hospitalizations were considered as readmissions. Baseline characteristics and outcomes were stratified for co-morbid CKD using ICD-10-encoding from the index cases. Cox regression was utilized for readmission endpoints and in-hospital mortality. In total, 174 829 index cases (mean age 79 ± 15 years, 49.9% female) were included; of these, 55.0% had coexisting CKD. Patients with CKD were older, suffered from worse HF-related symptoms, had a higher co-morbidity burden, and in-hospital mortality was increased at index and during follow-up. Prevalent CKD was associated with higher rehospitalization rates and was an independent predictor for in-hospital death. CONCLUSIONS: Within this HF inpatient cohort from a multicentric German database, CKD was diagnosed in more than half of the patients and was associated with increased in-hospital mortality at baseline and during follow-up. Rehospitalizations were observed earlier and more frequently in patients with HF and co-morbid CKD.

App-Based Mental Training to Reduce Atrial Fibrillation-Related Symptoms After Pulmonary Vein Isolation: MENTAL AF Trial.

BACKGROUND: Even after atrial fibrillation (AF) catheter ablation, many patients still experience relevant symptom burden. The objective of the MENTAL AF trial was to determine whether app-based mental training (MT) during the 3 months following pulmonary vein isolation reduces AF-related symptoms. METHODS AND RESULTS: Patients scheduled for pulmonary vein isolation were enrolled and randomized 1:1 to either app-based MT or usual care. Of 174 patients, 76 in the MT and 75 in the usual care group were included in the final analysis. The intervention was delivered by a daily 10-minute app-based MT. The primary outcome was the intergroup difference of the mean AF6 sum score, an AF-specific questionnaire, during the 3-month study period. Secondary outcomes included quality-of-life measures such as the AFEQT (Atrial Fibrillation Effect on Quality of Life). Mean age (SD) was 61 (8.7) years and 61 (41%) were women. The mean AF6 sum score over the study period was 8.9 (6.9) points in the MT group and 12.5 (10.1) in the usual care group (P=0.011). This referred to a reduction in the AF6 sum score compared with baseline of 75% in MT and 52% for usual care (P<0.001). The change in the AFEQT Global Score was 22.6 (16.3) and 15.7 (22.1), respectively; P=0.026. CONCLUSIONS: MENTAL AF showed that app-based MT as an adjunctive treatment tool following pulmonary vein isolation was feasible. App-based MT was found to be superior to standard care in reducing AF-related symptom burden and improving health-related quality of life. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04067427.

Patient Characteristics and Outcomes of Hospitalized Chronic Kidney Disease Patients with and without Type 2 Diabetes Mellitus: Observations from the German Claims Data-Based Cohort of the CaReMe-CKD Multinational Study.

Introduction: Type 2 diabetes mellitus (T2DM) is a leading cause of chronic kidney disease (CKD) globally. Both conditions substantially worsen patients' prognosis. Current data on German in-hospital CKD cohorts are scarce. The multinational CaReMe study was initiated to evaluate the current epidemiology and healthcare burden of cardiovascular, renal and metabolic diseases. In this substudy, we share real-world data on CKD inpatients stratified for coexisting T2DM derived from a large German hospital network. Methods: This study used administrative data of inpatient cases from 89 Helios hospitals from 01/01/2016 to 28/02/2022. Data were extracted from ICD-10-encoded discharge diagnoses and OPS-encoded procedures. The first case meeting a previously developed CKD definition (defined by ICD-10- and OPS-codes) was considered the index case for a particular patient. Subsequent hospitalizations were analysed for readmission statistics. Patient characteristics and pre-defined endpoints were stratified for T2DM at index case. Results: In total, 48,011 patients with CKD were included in the present analysis (mean age ± standard deviation, 73.8 ± 13.1 years; female, 44%) of whom 47.9% had co-existing T2DM. Patients with T2DM were older (75 ± 10.6 vs 72.7 ± 14.9 years, p < 0.001), but gender distribution was similar to patients without T2DM. The burden of cardiovascular disease was increased in patients with T2DM, and index and follow-up in-hospital mortality rates were higher. Non-T2DM patients were characterised by more advanced CKD at baseline. Patients with T2DM had consistently higher readmission numbers for all events of interest, except for readmissions due to kidney failure/dialysis, which were more common in non-T2DM patients. Conclusion: In this study, we present recent data on hospitalized patients with CKD in Germany. In this CKD cohort, nearly half had T2DM, which substantially affected cardiovascular disease burden, rehospitalization frequency and mortality. Interestingly, non-diabetic patients had more advanced underlying renal disease, which affected renal outcomes.

Retrospective, Observational Analysis on the Impact of SARS-CoV-2 Variant Omicron in Hospitalized Immunocompromised Patients in a German Hospital Network-The VISAGE Study.

AIMS: Endemic SARS-CoV-2 infections still burden the healthcare system and represent a considerable threat to vulnerable patient cohorts, in particular immunocompromised (IC) patients. This study aimed to analyze the in-hospital outcome of IC patients with severe SARS-CoV-2 infection in Germany. METHODS: This retrospective, observational study, analyzed administrative data from inpatient cases (n = 146,324) in 84 German Helios hospitals between 1 January 2022 and 31 December 2022 with regard to in-hospital outcome and health care burden in IC patients during the first 12 months of Omicron dominance. As the primary objective, in-hospital outcomes of patients with COVID-19-related severe acute respiratory infection (SARI) were analyzed by comparing patients with (n = 2037) and without IC diagnoses (n = 14,772). Secondary analyses were conducted on IC patients with (n = 2037) and without COVID-19-related SARI (n = 129,515). A severe in-hospital outcome as a composite endpoint was defined per the WHO definition if one of the following criteria were met: intensive care unit (ICU) treatment, mechanical ventilation (MV), or in-hospital death. RESULTS: In total, 12% of COVID-related SARI cases were IC patients, accounting for 15% of ICU admissions, 15% of MV use, and 16% of deaths, resulting in a higher prevalence of severe in-hospital courses in IC patients developing COVID-19-related SARI compared to non-IC patients (Odds Ratio, OR = 1.4, p < 0.001), based on higher in-hospital mortality (OR = 1.4, p < 0.001), increased need for ICU treatment (OR = 1.3, p < 0.001) and mechanical ventilation (OR = 1.2, p < 0.001). Among IC patients, COVID-19-related SARI profoundly increased the risk for severe courses (OR = 4.0, p < 0.001). CONCLUSIONS: Our findings highlight the vulnerability of IC patients to severe COVID-19. The persistently high prevalence of severe outcomes in these patients in the Omicron era emphasizes the necessity for continuous in-hospital risk assessment and monitoring of IC patients.

Case Report: Four cases of cardiac sarcoidosis in patients with inherited cardiomyopathy-a phenotypic overlap, co-existence of two rare cardiomyopathies or a second-hit disease.

Cardiac sarcoidosis (CS), a rare condition characterized by non-caseating granulomas, can manifest with symptoms such as atrioventricular block and ventricular tachycardia (VT), as well as mimic inherited cardiomyopathies. A 48-year-old male presented with recurrent VT. The initial 18F-fluorodeoxyglucose positron emission tomography (18FDG-PET) scan showed uptake of the mediastinal lymph node. Cardiovascular magnetic resonance (CMR) demonstrated intramyocardial fibrosis. The follow-up 18FDG-PET scan revealed the presence of tracer uptake in the left ventricular (LV) septum, suggesting the likelihood of CS. Genetic testing identified a pathogenic LMNA variant. A 47-year-old female presented with complaints of palpitations and syncope. An Ajmaline provocation test confirmed Brugada syndrome (BrS). CMR revealed signs of cardiac inflammation. An endomyocardial biopsy (EMB) confirmed the diagnosis of cardiac sarcoidosis. Polymorphic VT was induced during an electrophysiological study, and an implantable cardioverter-defibrillator (ICD) was implanted. A 58-year-old woman presented with sustained VT with a prior diagnosis of hypertrophic cardiomyopathy (HCM). A genetic work-up identified the presence of a heterozygous MYBC3 variant of unknown significance (VUS). CMR revealed late gadolinium enhancement (LGE), while the 18FDG-PET scan demonstrated LV tracer uptake. The immunosuppressive therapy was adjusted, and no further VTs were observed. A 28-year-old male athlete with right ventricular dilatation and syncope experienced a cardiac arrest during training. Genetic testing identified a pathogenic mutation in PKP2. The autopsy has confirmed the presence of ACM and a distinctive extracardiac sarcoidosis. Cardiac sarcoidosis and inherited cardiomyopathies may interact in several different ways, altering the clinical presentation. Overlapping pathologies are frequently overlooked. Delayed or incomplete diagnosis risks inadequate treatment. Thus, genetic testing and endomyocardial biopsies should be recommended to obtain a clear diagnosis.