Journal: Clin Res Cardiol

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Abstract

Atrial fibrillation detection with long-term continuous Holter ECG recording in patients with high cardiovascular risk and clinical palpitations: the prospective after study.

Halimi F, Sabouret P, Huberman JP, Ouazana L, ... Lafont C, Lellouche N
Aim
New technologic tools for continuous ECG monitoring have been developed to detect and treat atrial fibrillation (AF) in specific populations with high cardiovascular risk. We evaluated the prevalence and the management of AF diagnosed in patients with high cardiovascular risk and non-documented clinical palpitation undergoing systematic 14-day continuous ECG-Holter monitoring.
Methods
Patients were prospectively enrolled from December 2019 to December 2021 in this multicentre study, sponsored by the French National College of Cardiology. Patients met the following criteria: CHA2DS2VASc score ≥ 2 in males and ≥ 3 in females and clinical palpitations without previously documented arrhythmia. Enrolled patients underwent a continuous 14-day Holter-ECG monitoring for arrhythmia detection.
Results
Among the 336 included patients, 39% were male, 75% were greater than 65 years of age and 46.5% had suffered a prior stroke. AF was detected in 14% of patients, among which 23.4% were detected in the first 24 h of monitoring. Finally, age ≥ 65 years (p = 0.037) was significantly associated with AF, as well as male gender (p = 0.023) and a lower rate of antiplatelet therapy (p = 0.018). Patients with diagnosed AF had a prescription of anticoagulation therapy in 90%. Antiarrhythmic drugs were administered in 90% of AF patients and 13% underwent AF ablation.
Conclusions
The systematic AF screening of patients with palpitations and high cardiovascular risk resulted in a diagnostic yield of AF in 14% of the population with a 14-day continuous ECG-Holter monitor. This strategy resulted in the prescription of anticoagulation and antiarrhythmic therapy in 90% of the AF detected population.

© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.

Clin Res Cardiol: 28 Sep 2022; epub ahead of print
Halimi F, Sabouret P, Huberman JP, Ouazana L, ... Lafont C, Lellouche N
Clin Res Cardiol: 28 Sep 2022; epub ahead of print | PMID: 36169720
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Abstract

Secondary prevention in diabetic and nondiabetic coronary heart disease patients: Insights from the German subset of the hospital arm of the EUROASPIRE IV and V surveys.

Ungethüm K, Wiedmann S, Wagner M, Leyh R, ... Störk S, Heuschmann PU
Background
Patients with coronary heart disease (CHD) with and without diabetes mellitus have an increased risk of recurrent events requiring multifactorial secondary prevention of cardiovascular risk factors. We compared prevalences of cardiovascular risk factors and its determinants including lifestyle, pharmacotherapy and diabetes mellitus among patients with chronic CHD examined within the fourth and fifth EUROASPIRE surveys (EA-IV, 2012-13; and EA-V, 2016-17) in Germany.
Methods
The EA initiative iteratively conducts European-wide multicenter surveys investigating the quality of secondary prevention in chronic CHD patients aged 18 to 79 years. The data collection in Germany was performed during a comprehensive baseline visit at study centers in Würzburg (EA-IV, EA-V), Halle (EA-V), and Tübingen (EA-V).
Results
384 EA-V participants (median age 69.0 years, 81.3% male) and 536 EA-IV participants (median age 68.7 years, 82.3% male) were examined. Comparing EA-IV and EA-V, no relevant differences in risk factor prevalence and lifestyle changes were observed with the exception of lower LDL cholesterol levels in EA-V. Prevalence of unrecognized diabetes was significantly lower in EA-V as compared to EA-IV (11.8% vs. 19.6%) while the proportion of prediabetes was similarly high in the remaining population (62.1% vs. 61.0%).
Conclusion
Between 2012 and 2017, a modest decrease in LDL cholesterol levels was observed, while no differences in blood pressure control and body weight were apparent in chronic CHD patients in Germany. Although the prevalence of unrecognized diabetes decreased in the later study period, the proportion of normoglycemic patients was low. As pharmacotherapy appeared fairly well implemented, stronger efforts towards lifestyle interventions, mental health programs and cardiac rehabilitation might help to improve risk factor profiles in chronic CHD patients.

© 2022. The Author(s).

Clin Res Cardiol: 27 Sep 2022; epub ahead of print
Ungethüm K, Wiedmann S, Wagner M, Leyh R, ... Störk S, Heuschmann PU
Clin Res Cardiol: 27 Sep 2022; epub ahead of print | PMID: 36166067
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Abstract

Effectiveness of implantable loop recorder and Holter electrocardiographic monitoring for the detection of arrhythmias in patients with peripartum cardiomyopathy.

Hoevelmann J, Sliwa K, Briton O, Ntsekhe M, Chin A, Viljoen C
Background
Patients with peripartum cardiomyopathy (PPCM) are at increased risk of sudden cardiac death (SCD). However, the exact underlying mechanisms of SCD in PPCM remain unknown. By means of extended electrocardiographic monitoring, we aimed to systematically characterize the burden of arrhythmias occurring in patients with newly diagnosed PPCM.
Methods and results
Twenty-five consecutive women with PPCM were included in this single-centre, prospective clinical trial and randomised to receiving either 24 h-Holter ECG monitoring followed by implantable loop recorder implantation (ILR; REVEAL XT, Medtronic®) or 24 h-Holter ECG monitoring alone. ILR + 24 h-Holter monitoring had a higher yield of arrhythmic events compared to 24 h-Holter monitoring alone (40% vs 6.7%, p = 0.041). Non-sustained ventricular tachycardia (NSVT) occurred in four patients (16%, in three patients detected by 24 h-Holter, and multiple episodes detected by ILR in one patient). One patient deceased from third-degree AV block with an escape rhythm that failed. All arrhythmic events occurred in patients with a severely impaired LV systolic function.
Conclusions
We found a high prevalence of potentially life-threatening arrhythmic events in patients with newly diagnosed PPCM. These included both brady- and tachyarrhythmias. Our results highlight the importance of extended electrocardiographic monitoring, especially in those with severely impaired LV systolic function. In this regard, ILR in addition to 24 h-Holter monitoring had a higher yield of VAs as compared to 24 h-Holter monitoring alone. In settings where WCDs are not readily available, ILR monitoring should be considered in patients with severely impaired LV systolic dysfunction, especially after uneventful 24 h-Holter monitoring.
Trial registration
Pan African Clinical Trials Registry: PACTR202104866174807. Extended electrocardiographic monitoring for the detection of arrhythmias in PPCM. (CHB, complete heart block/third degree AV block; ECG, electrocardiogram; ILR, implantable loop recorder; NSVT, non-sustained ventricular tachycardia; PPCM, peripartum cardiomyopathy).

© 2022. The Author(s).

Clin Res Cardiol: 22 Sep 2022; epub ahead of print
Hoevelmann J, Sliwa K, Briton O, Ntsekhe M, Chin A, Viljoen C
Clin Res Cardiol: 22 Sep 2022; epub ahead of print | PMID: 36131137
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Abstract

Pulsed-field ablation-based pulmonary vein isolation: acute safety, efficacy and short-term follow-up in a multi-center real world scenario.

Lemoine MD, Fink T, Mencke C, Schleberger R, ... Rillig A, Metzner A
Purpose
Pulsed-field ablation (PFA) is a new energy source to achieve pulmonary vein isolation (PVI) by targeted electroporation of cardiomyocytes. Experimental and controlled clinical trial data suggest good efficacy of PFA-based PVI. We aimed to assess efficacy, safety and follow-up of PFA-based PVI in an early adopter routine care setting.
Methods
Consecutive patients with symptomatic paroxysmal or persistent atrial fibrillation (AF) underwent PVI using the Farawave® PFA ablation catheter in conjunction with three-dimensional mapping at two German high-volume ablation centers. PVI was achieved by applying 8 PFA applications in each PV.
Results
A total of 138 patients undergoing a first PVI (67 ± 12 years, 66% male, 62% persistent AF) were treated. PVI was achieved in all patients by deploying 4563 applications in 546 PVs (8.4 ± 1.0/PV). Disappearance of PV signals after the first application was demonstrated in 544/546 PVs (99.6%). More than eight PFA applications were performed in 29/546 PVs (6%) following adapted catheter positioning or due to reconnection as assessed during remapping. Mean procedure time was 78 ± 22 min including pre- and post PVI high-density voltage mapping. PFA catheter LA dwell-time was 23 ± 9 min. Total fluoroscopy time and dose area product were 16 ± 7 min and 505 [275;747] cGy*cm2. One pericardial tamponade (0.7%), one transient ST-elevation (0.7%) and three groin complications (2.2%) occurred. 1-year follow-up showed freedom of arrhythmia in 90% in patients with paroxysmal AF (n = 47) and 60% in patients with persistent AF (n = 82, p = 0.015).
Conclusions
PFA-based PVI is acutely highly effective and associated with a beneficial safety and low recurrence rate.

© 2022. The Author(s).

Clin Res Cardiol: 22 Sep 2022; epub ahead of print
Lemoine MD, Fink T, Mencke C, Schleberger R, ... Rillig A, Metzner A
Clin Res Cardiol: 22 Sep 2022; epub ahead of print | PMID: 36131138
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Abstract

The prognostic significance of bundle branch block in acute heart failure: a systematic review and meta-analysis.

Aguiló O, Castells X, Miró Ò, Mueller C, Chioncel O, Trullàs JC
Aims
The aim of this study was to conduct a meta-analysis of prospective studies assessing the relationship between bundle branch block (BBB) or wide QRS and risk of all-cause mortality in patients with acute heart failure (AHF).
Methods and results
We searched the PubMed, Scopus and Web of Science database from inception to February 2022 to identify single centre or multicentre studies including a minimum of 400 patients and assessing the association between BBB or wide QRS and mortality in patients with AHF. Study-specific hazard ratio (HR) estimates were combined using a random-effects meta-analysis. Two meta-analyses were performed: (1) grouping by conduction disturbance and follow-up length and, (2) using the results from the longest follow-up for each study and grouping by the type of BBB. The meta-analysis included 21 publications with a total of 116,928 patients. Wide QRS (considering right (RBBB) and left (LBBB) altogether) was associated with a significant increment in the risk of all-cause mortality (pooled adjusted HR 1.112, 95% CI 1.065-1.160). The increased risk of death was also present when LBBB (HR 1.121, 95% CI 1.042-1.207) and RBBB (HR 1.187, 95% CI 1.045-1.348) were considered individually. There was no difference in risk between LBBB and RBBB (P for interaction = 0.533). Other outcomes including sudden death, rehospitalization and a combination of cardiovascular death or rehospitalization were also increased in patients with BBB or wide QRS.
Conclusions
This meta-analysis suggests a modest increase in the risk of all-cause mortality among patients with AHF and BBB or wide QRS, irrespective of the type of BBB.

© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.

Clin Res Cardiol: 18 Sep 2022; epub ahead of print
Aguiló O, Castells X, Miró Ò, Mueller C, Chioncel O, Trullàs JC
Clin Res Cardiol: 18 Sep 2022; epub ahead of print | PMID: 36116092
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Abstract

Hypercholesterolemia diagnosis, treatment patterns and target achievement in patients with acute coronary syndromes in Germany.

Gitt AK, Parhofer KG, Laufs U, März W, ... Bramlage P, Marx N
Background
Patients who experience an acute coronary syndrome (ACS) are at high risk of further cardiovascular events. Long-term treatment of cardiovascular risk factors, such as hyperlipidemia, is critical to prevent progression of coronary heart disease. However, many patients do not reach recommended target levels for low-density lipoprotein (LDL) cholesterol, despite receiving lipid-lowering therapy.
Objective
To obtain an insight into the current treatment situation for very high-risk patients after an initial ACS in Germany.
Methods
The multicenter HYDRA-ACS registry study was initiated to document the clinical characteristics of very high-risk patients with ACS and hyperlipidemia in clinical practice. In addition, lipid profiles, lipid-lowering therapy, and lipid target achievement during treatment were documented over 1 year.
Results
353 patients who were documented had a mean age of 57.3 years, mean body mass index was 28.6 kg/m2, and 73.4% were male; 52.4% had a family history of myocardial infarction (MI) and 32.6% a family history of coronary heart disease (CHD). Patients\' medical histories commonly included CHD (32.9%), percutaneous coronary intervention (PCI; 25.5%), and previous ACS (23.0%). Common comorbidities included hypertension (68.6%), diabetes (17.3%), heart failure (16.7%), and stable angina pectoris (15.9%). The proportion of patients receiving lipid-lowering therapy increased from 65.7% at baseline to 100% at the 12-month follow-up (p < 0.0001). Substantial increases in use were seen for statins (85.0% vs. 36.5%, p = 0.0002) and cholesterol resorption inhibitors (32.9% vs. 8.6%, p = 0.0003). Use of combination therapy increased. The proportion of patients undertaking physical exercise increased (p < 0.0001), as did consumption of fruit and vegetables (p = 0.0222) and fish (p = 0.0162), while alcohol consumption decreased (p = 0.0019). Median LDL cholesterol level decreased significantly from baseline (87 vs. 166 mg/dL, p < 0.0001), and the proportion of patients with a level < 70 mg/dL increased (50.0% vs. 5.7%, p < 0.0001). Median HDL cholesterol increased (47 vs. 45 mg/dL, p = 0.0235) and median triglyceride level decreased (119 vs. 148 mg/dL, p = 0.0080). The proportion of patients receiving antihypertensive drugs and platelet aggregation inhibitors increased. The most frequent cardiovascular events during the 12-month follow-up were PCI (25.9%) and cardiac catheterization without PCI (12.9%); MI occurred in 2.4% of patients; no deaths were reported.
Conclusions
This study provides a contemporary picture of the treatment of hyperlipidemia after ACS in patients in Germany. Despite treatment with lipid-lowering therapy, many patients did not achieve recommended lipid targets by 12 months after an ACS event.

© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.

Clin Res Cardiol: 17 Sep 2022; epub ahead of print
Gitt AK, Parhofer KG, Laufs U, März W, ... Bramlage P, Marx N
Clin Res Cardiol: 17 Sep 2022; epub ahead of print | PMID: 36114838
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Abstract

Cardiac magnetic resonance abnormalities in patients with acute myocarditis proven by septal endomyocardial biopsy.

Peretto G, Merlo M, Gentile P, Porcari A, ... Esposito A, Pedrotti P
Background
Previous studies suggest low diagnostic sensitivity of cardiac magnetic resonance (CMR) imaging based on Lake Louise criteria (LLC) to identify patients with complicated presentations of acute myocarditis (AM). We evaluated classic and updated LLC in patients with AM proven by right ventricular septal endomyocardial biopsy (RVS-EMB).
Methods
From an initial population of 499 patients with clinically suspected AM from a multicenter retrospective cohort, we included 74 patients with histologically proven myocarditis on RVS-EMB and available CMR within 30 days since admission. The prevalence of total and septal CMR abnormalities [namely, T2-weighted images (T2W), late gadolinium enhancement (LGE), T2 and T1 mapping, and extracellular volume (ECV)] were assessed in patients with complicated vs. uncomplicated AM.
Results
Among 74 patients [mean age 38 ± 15 years, 65% males, left ventricular ejection fraction (LVEF) 40 ± 18%] with RVS-EMB-proven AM, 53 (72%) had a complicated presentation. The classic LLC were positive in 56/74 patients (76%), whereas the updated ones were positive in 41/41 of cases (100%). Septal involvement, documented in 48/74 patients (65%) by conventional T2W/LGE and in 39/41 cases (95%) by mapping techniques (p < 0.001), was more common in patients with complicated AM. In the 41 patients undergoing both evaluations, CMR sensitivity for myocarditis was 85% for the classic LLC vs. 100% for the updated LLC (p = 0.006).
Conclusion
In patients with myocarditis on RVS-EMB, CMR using updated LLC has high sensitivity in the detection of AM when performed within 30 days. Septal abnormalities are more common in patients with complicated AM.

© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.

Clin Res Cardiol: 16 Sep 2022; epub ahead of print
Peretto G, Merlo M, Gentile P, Porcari A, ... Esposito A, Pedrotti P
Clin Res Cardiol: 16 Sep 2022; epub ahead of print | PMID: 36112234
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Abstract

Contemporary treatment of mitral valve disease with transcatheter mitral valve implantation.

Wienemann H, Mauri V, Ochs L, Körber MI, ... Adam M, Kuhn E
Background
Transcatheter mitral valve implantation (TMVI) with self-expanding (SAV) or balloon-expandable (BAV) valves are rising as promising treatment options for high-risk patients with symptomatic mitral valve (MVD) disease unsuitable for alternative treatment options.
Aims
The aim of this study was to examine the clinical, procedural and outcome parameters of patients undergoing SAV or BAV for MVD.
Methods
In this observational and single-center case series, fifteen consecutive patients treated with the Tendyne Mitral Valve System (SAV) and thirty-one patients treated with SAPIEN prosthesis (BAV) were included.
Results
The patients (aged 78 years [interquartile range (IQR): 65.5 to 83.1 years], 41% women, EuroSCORE II 10.3% [IQR: 5.5 to 17.0%] were similar regarding baseline characteristics, despite a higher rate of prior heart valve surgery and prevalence of MV stenosis in the SAV-group. At discharge, the SAV-group had a mean transvalvular gradient of 4.2 mmHg, whereas the BAV-group had a mean transvalvular gradient of 6.2 mmHg. None or trace paravalvular leakage (PVL) was assessed in 85% in SAV-group and 80% in the BAV-group. 320 day all-cause and cardiac mortality rates were comparable in both groups (SAV: 26.7% vs BAV: 20%, p = 0.60). Four deaths occurred early in the SAV-group until 32 days of follow-up.
Conclusions
In high-risk patients with MVD, TMVI presents a promising treatment option with encouraging mid-term outcomes and good valve durability. TMVI either with BAV or SAV may be developed to an established treatment option.

© 2022. The Author(s).

Clin Res Cardiol: 15 Sep 2022; epub ahead of print
Wienemann H, Mauri V, Ochs L, Körber MI, ... Adam M, Kuhn E
Clin Res Cardiol: 15 Sep 2022; epub ahead of print | PMID: 36107228
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Abstract

Paclitaxel drug-coated balloon-only angioplasty for de novo coronary artery disease in elective clinical practice.

Merinopoulos I, Gunawardena T, Corballis N, Bhalraam U, ... Vassiliou VS, Eccleshall SC
Objective
We aimed to investigate the safety of drug-coated balloon (DCB)-only angioplasty compared to drug-eluting stent (DES), as part of routine clinical practice.
Background
The recent BASKETSMALL2 trial demonstrated the safety and efficacy of DCB angioplasty for de novo small vessel disease. Registry data have also demonstrated that DCB angioplasty is safe; however, most of these studies are limited due to long recruitment time and a small number of patients with DCB compared to DES. Therefore, it is unclear if DCB-only strategy is safe to incorporate in routine elective clinical practice.
Methods
We compared all-cause mortality and major cardiovascular endpoints (MACE), including unplanned target lesion revascularisation (TLR) of all patients treated with DCB or DES for first presentation of stable angina due to de novo coronary artery disease between 1st January 2015 and 15th November 2019. Data were analysed with Cox regression models and cumulative hazard plots.
Results
We present 1237 patients; 544 treated with DCB and 693 treated with DES for de novo, mainly large-vessel coronary artery disease. On multivariable Cox regression analysis, only age and frailty remained significant adverse predictors of all-cause mortality. Univariable, cumulative hazard plots showed no difference between DCB and DES for either all-cause mortality or any of the major cardiovascular endpoints, including unplanned TLR. The results remained unchanged following propensity score-matched analysis.
Conclusion
DCB-only angioplasty, for stable angina and predominantly large vessels, is safe compared to DES as part of routine clinical practice, in terms of all-cause mortality and MACE, including unplanned TLR.

© 2022. The Author(s).

Clin Res Cardiol: 14 Sep 2022; epub ahead of print
Merinopoulos I, Gunawardena T, Corballis N, Bhalraam U, ... Vassiliou VS, Eccleshall SC
Clin Res Cardiol: 14 Sep 2022; epub ahead of print | PMID: 36104455
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Abstract

Normative values of non-invasively assessed RV function and pulmonary circulation coupling for pre-participation screening derived from 497 male elite athletes.

Bauer P, Tello K, Kraushaar L, Dörr O, ... Hamm CW, Most A
Background
Reference values for right ventricular function and pulmonary circulation coupling were recently established for the general population. However, normative values for elite athletes are missing, even though exercise-related right ventricular enlargement is frequent in competitive athletes.
Methods
We examined 497 healthy male elite athletes (age 26.1 ± 5.2 years) of mixed sports with a standardized transthoracic echocardiographic examination. Tricuspid annular plane excursion (TAPSE) and systolic pulmonary artery pressure (SPAP) were measured. Pulmonary circulation coupling was calculated as TAPSE/SPAP ratio. Two age groups were defined (18-29 years and 30-39 years) and associations of clinical parameters with the TAPSE/SPAP ratio were determined and compared for each group.
Results
Athletes aged 18-29 (n = 349, 23.8 ± 3.5 years) displayed a significantly lower TAPSE/SPAP ratio (1.23 ± 0.3 vs. 1.31 ± 0.33 mm/mmHg, p = 0.039), TAPSE/SPAP to body surface area (BSA) ratio (0.56 ± 0.14 vs. 0.6 ± 0.16 mm*m2/mmHg, p = 0.017), diastolic blood pressure (75.6 ± 7.9 vs. 78.8 ± 10.7 mmHg, p < 0.001), septal wall thickness (10.2 ± 1.1 vs. 10.7 ± 1.1 mm, p = 0.013) and left atrial volume index (27.5 ± 4.5 vs. 30.8 ± 4.1 ml/m2, p < 0.001), but a higher SPAP (24.2 ± 4.5 vs. 23.2 ± 4.4 mmHg, p = 0.035) compared to athletes aged 30-39 (n = 148, 33.1 ± 3.4 years). TAPSE was not different between the age groups. The TAPSE/SPAP ratio was positively correlated with left ventricular stroke volume (r = 0.133, p = 0.018) and training amount per week (r = 0.154, p = 0.001) and negatively correlated with E/E\' lat. (r = -0.152, p = 0.005).
Conclusion
The reference values for pulmonary circulation coupling determined in this study could be used to interpret and distinguish physiological from pathological cardiac remodeling in male elite athletes.

© 2022. The Author(s).

Clin Res Cardiol: 14 Sep 2022; epub ahead of print
Bauer P, Tello K, Kraushaar L, Dörr O, ... Hamm CW, Most A
Clin Res Cardiol: 14 Sep 2022; epub ahead of print | PMID: 36102951
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Abstract

Effects of percutaneous coronary intervention on dyspnea in stable coronary artery disease.

Wester M, Koll F, Luedde M, Langer C, ... Maier LS, Sossalla S
Background
Dyspnea is a frequent symptom in patients with stable coronary artery disease (CAD) and is recognized as a possible angina equivalent.
Objectives
This study was to assess the impact of percutaneous coronary intervention (PCI) on dyspnea, quality of life, and angina pectoris in patients with stable CAD.
Methods
The prospective, multi-center PLA-pCi-EBO-pilot trial included 144 patients with symptomatic stable CAD and successful PCI. The prespecified endpoints angina pectoris (Seattle Angina Questionnaire-SAQ) and dyspnea (NYHA scale) were assessed 6 months after PCI. Predictors for symptomatic improvement were assessed with uni- and multivariable logistic regression analyses.
Results
Patients with concomitant dyspnea had worse SAQ physical limitation scores at baseline (49.5 ± 21.0 vs 58.9 ± 22.0, p = 0.013) but showed no difference for angina frequency or quality of life. Overall, symptomatic burden of angina pectoris and dyspnea was alleviated by PCI. However, patients with concomitant dyspnea had markedly worse scores for physical limitation (78.9 ± 25.0 vs 94.3 ± 10.6, p < 0.001), angina frequency (77.9 ± 22.8 vs 91.1 ± 12.4, p < 0.001), and quality of life (69.4 ± 24.1 vs 82.5 ± 14.4, p < 0.001) after PCI. The prevalence of dyspnea (NYHA class ≥ 2) declined from 73% before PCI to 54%. Of 95 initially dyspneic patients, 57 (60%) improved at least one NYHA class 6 months after PCI. In a multivariable logistic regression analysis, \"atypical angina pectoris\" was associated with improved NYHA class, whereas \"diabetes mellitus\" had a negative association.
Conclusion
PCI effectively reduced dyspnea, which is a frequent and demanding symptom in patients with CAD. The German Clinical Trials Register registration number is DRKS0001752 ( www.drks.de ).

© 2022. The Author(s).

Clin Res Cardiol: 13 Sep 2022; epub ahead of print
Wester M, Koll F, Luedde M, Langer C, ... Maier LS, Sossalla S
Clin Res Cardiol: 13 Sep 2022; epub ahead of print | PMID: 36100700
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Abstract

GARFIELD-AF: risk profiles, treatment patterns and 2-year outcomes in patients with atrial fibrillation in Germany, Austria and Switzerland (DACH) compared to 32 countries in other regions worldwide.

Haas S, Camm JA, Harald D, Steffel J, ... Kakkar AK, GARFIELD-AF Investigators
Background
The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) is a worldwide non-interventional study of stroke prevention in patients with non-valvular AF.
Methods and results
52,080 patients with newly diagnosed AF were prospectively enrolled from 2010 to 2016. 4121 (7.9%) of these patients were recruited in DACH [Germany (n = 3567), Austria (n = 465) and Switzerland (n = 89) combined], and 47,959 patients were from 32 countries in other regions worldwide (ORW). Hypertension was most prevalent in DACH and ORW (85.3% and 75.6%, respectively). Diabetes, hypercholesterolaemia, carotid occlusive disease and vascular disease were more prevalent in DACH patients vs ORW (27.6%, 49.4%, 5.8% and 29.0% vs 21.7%, 40.9%, 2.8% and 24.5%). The use of non-vitamin K antagonist oral anticoagulants (NOACs) increased more in DACH over time. Management of vitamin K antagonists was suboptimal in DACH and ORW (time in therapeutic range of INR ≥ 65% in 44.6% and 44.4% of patients or ≥ 70% in 36.9% and 36.0% of patients, respectively). Adjusted rates of cardiovascular mortality and MI/ACS were higher in DACH while non-haemorrhagic stroke/systemic embolism was lower after 2-year follow-up.
Conclusions
Similarities and dissimilarities in AF management and clinical outcomes are seen in DACH and ORW. The increased use of NOAC was associated with a mismatch of risk-adapted anticoagulation (over-and-undertreatment) in DACH. Suboptimal control of INR requires educational activities in both regional groups. Higher rates of cardiovascular death in DACH may reflect the higher risk profile of these patients and lower rates of non-haemorrhagic stroke could be associated with increased NOAC use.

© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.

Clin Res Cardiol: 12 Sep 2022; epub ahead of print
Haas S, Camm JA, Harald D, Steffel J, ... Kakkar AK, GARFIELD-AF Investigators
Clin Res Cardiol: 12 Sep 2022; epub ahead of print | PMID: 36094573
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Abstract

Temporal trends in incidence, patient characteristics, microbiology and in-hospital mortality in patients with infective endocarditis: a contemporary analysis of 86,469 cases between 2007 and 2019.

Becher PM, Goßling A, Fluschnik N, Schrage B, ... Westermann D, Kalbacher D
Background
Infective endocarditis (IE) is characterized by high morbidity and mortality rates, despite recent improvements in diagnostics and treatment. We aimed to investigate incidence, clinical characteristics, and in-hospital mortality in a large-scale nationwide cohort.
Methods
Using data from the German Federal Bureau of Statistics, all IE cases in Germany between 2007 and 2019 were analyzed. Logistic regression models were fitted to assess associations between clinical factors and in-hospital mortality.
Results
In total, 86,469 patients were hospitalized with IE between 2007 and 2019. The mean age was 66.5 ± 14.7 years and 31.8% (n = 27,534/86,469) were female. Cardiovascular (CV) comorbidities were common. The incidence of IE in the German population increased from 6.3/100,000 to 10.2/100,000 between 2007 and 2019. Staphylococcus (n = 17,673/86,469; 20.4%) and streptococcus (n = 17,618/86,469; 20.4%) were the most common IE-causing bacteria. The prevalence of staphylococcus gradually increased over time, whereas blood culture-negative IE (BCNIE) cases decreased. In-hospital mortality in patients with IE was 14.9%. Compared to BCNIE, staphylococcus and Gram-negative pathogens were associated with higher in-hospital mortality. In multivariable analysis, factors associated with higher likelihood of in-hospital mortality were advanced age, female sex, CV comorbidities (e.g., heart failure, COPD, diabetes, stroke), need for dialysis or invasive ventilation, and sepsis.
Conclusions
In this contemporary cohort, incidence of IE increased over time and in-hospital mortality remained high (~ 15%). While staphylococcus and streptococcus were the predominant microorganisms, bacteremia with staphylococcus and Gram-negative pathogens were associated with higher likelihood of in-hospital mortality. Our results highlight the need for new preventive strategies and interventions in patients with IE. Infective endocarditis in Germany. BCNIE blood culture-negative infective endocarditis, IE infective endocarditis.

© 2022. The Author(s).

Clin Res Cardiol: 12 Sep 2022; epub ahead of print
Becher PM, Goßling A, Fluschnik N, Schrage B, ... Westermann D, Kalbacher D
Clin Res Cardiol: 12 Sep 2022; epub ahead of print | PMID: 36094574
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Impact:
Abstract

Impact of common rhythm disturbances on echocardiographic measurements and interpretation.

Gomes DA, Santos RR, Freitas P, Paiva MS, ... Flachskampf FA, Andrade MJ
Transthoracic echocardiography (TTE) remains the workhorse of noninvasive cardiac imaging, allowing to easily obtain precise information on cardiac structure and function. Over time, Doppler interrogation of blood flow velocities, direction, and timing in several locations within the heart became the primary method for haemodynamic assessment, replacing cardiac catheterization in most clinical settings and providing valuable diagnostic and prognostic information on a wide spectrum of cardiac pathological processes. Abnormalities in heart rate, rhythm, and intracardiac electrical conduction are commonly encountered during the performance of echocardiographic studies. Up to now, only a modest attention has been given to the impact of these abnormalities on the reading and interpretation of echocardiographic examination and this assessment has not yet been carried out in a global and systematic way. Tachyarrhythmias, bradyarrhythmias and atrioventricular conduction disturbances influence cardiac structure and mechanics as well as Doppler flow patterns. For this reason, and to be able to avoid misinterpretation, echocardiographers must be aware of the consequences of these common rhythm disturbances on echocardiographic findings. This narrative review aims to describe the current knowledge on this topic, focusing on the expected mechanical effects and Doppler patterns observed on transthoracic echocardiography in patients with common rhythm (tachycardia and bradycardia, atrial flutter and fibrillation and ectopic beats) and conduction disturbances (namely, atrioventricular block).

© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.

Clin Res Cardiol: 10 Sep 2022; epub ahead of print
Gomes DA, Santos RR, Freitas P, Paiva MS, ... Flachskampf FA, Andrade MJ
Clin Res Cardiol: 10 Sep 2022; epub ahead of print | PMID: 36087115
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Impact:
Abstract

Incidence and predictors of radial artery occlusion following transradial coronary angiography: the proRadial trial.

Schlosser J, Herrmann L, Böhme T, Bürgelin K, ... Neumann FJ, Hochholzer W
Objectives
This study investigated the contemporary incidence and predictors of radial artery occlusion as well as the effectiveness of antithrombotic treatment for radial artery occlusion following transradial coronary angiography.
Background
The radial artery is the standard access for coronary angiography and even complex interventions. Postprocedural radial artery occlusion is still a common and significant complication.
Methods
This prospective study enrolled 2004 patients following transradial coronary angiography. After sheath removal, hemostasis was obtained in a standardized fashion. Radial artery patency was evaluated by duplex ultrasonography in all patients. In case of occlusion, oral anticoagulation was recommended and patients were scheduled for a 30-day follow-up including Doppler ultrasonography.
Results
A new-diagnosed radial occlusion was found in 4.6% of patients. The strongest independent predictors of radial occlusion were female sex and active smoking status. In the subgroup of patients with percutaneous coronary interventions, female sex followed by sheath size > 6 French were the strongest predictors of radial occlusion. 76 of 93 patients with radial occlusion received an oral anticoagulation for 30 days. However, reperfusion at 30 days was found in 32% of patients on oral anticoagulation.
Conclusion
The incidence of radial artery occlusion following coronary angiography in contemporary practice appears with 4.6% to be lower as compared to previous cohorts. Female sex and smoking status are the strongest independent predictors of radial occlusion followed by procedural variables. The limited effectiveness of oral anticoagulation for treatment of radial artery occlusion suggests a primarily traumatic than thrombotic mechanism of this complication.

© 2022. The Author(s).

Clin Res Cardiol: 08 Sep 2022; epub ahead of print
Schlosser J, Herrmann L, Böhme T, Bürgelin K, ... Neumann FJ, Hochholzer W
Clin Res Cardiol: 08 Sep 2022; epub ahead of print | PMID: 36074269
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Impact:
Abstract

Propensity matched comparison of TAVI and SAVR in intermediate-risk patients with severe aortic stenosis and moderate-to-severe chronic kidney disease: a subgroup analysis from the German Aortic Valve Registry.

Mas-Peiro S, Faerber G, Bon D, Herrmann E, ... Walther T, GARY-Executive Board
Objective
We compared TAVI vs. SAVR in patients with moderate-to-severe chronic kidney disease (eGFR 15-60 ml/min/1.73 m2) for whom both procedures could possibly be considered (age ≤ 80 years, STS-score 4-8).
Background
According to both ACC/AHA and ESC/EACTS recent guidelines, aortic stenosis may be treated with either transcatheter (TAVI) or surgical (SAVR) aortic valve replacement in a subgroup of patients. A shared therapeutic decision is made by a heart team based on individual factors, including chronic kidney disease (CKD).
Methods
Data from the large nationwide German Aortic Valve Registry were used. A propensity score method was used to select 704 TAVI and 374 SAVR matched patients. Primary endpoint was 1-year survival. Secondary endpoints were clinical complications, including pacemaker implantation, vascular complications, myocardial infarction, bleeding, and the need for new-onset dialysis.
Results
One-year survival was similar (HR [95% CI] for TAVI 1.271 [0.795, 2.031], p = 0.316), with no divergence in Kaplan-Meier curves. In spite of post-procedural short-term survival being numerically higher for TAVI patients and 1-year survival being numerically higher for SAVR patients, such differences did not reach statistical significance (96.4% vs. 94.2%, p = 0.199, and 86.2% vs. 81.2%, p = 0.316, respectively). In weighted analyses, pacemaker implantation, vascular complications, and were significantly more common with TAVI; whereas myocardial infarction, bleeding requiring transfusion, and longer ICU-stay and overall hospitalization were higher with SAVR. Temporary dialysis was more common with SAVR (p < 0.0001); however, a probable need for chronic dialysis was rare and similar in both groups.
Conclusion
Both TAVI and SAVR led to comparable and excellent results in patients with moderate-to-severe CKD in an intermediate-risk population of patients with symptomatic severe aortic stenosis for whom both therapies could possibly be considered.

© 2022. The Author(s).

Clin Res Cardiol: 08 Sep 2022; epub ahead of print
Mas-Peiro S, Faerber G, Bon D, Herrmann E, ... Walther T, GARY-Executive Board
Clin Res Cardiol: 08 Sep 2022; epub ahead of print | PMID: 36074270
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Impact:
Abstract

Chronic cigarette smoking is associated with increased arterial stiffness in men and women: evidence from a large population-based cohort.

Hahad O, Schmitt VH, Arnold N, Keller K, ... Daiber A, Münzel T
Background
Cigarette smoking is a threat to global human health and a leading cause of the cardiovascular disease (CVD) morbidity and mortality. Importantly, sex-specific differences in smoking-induced arterial stiffness, an early key event in the development of atherosclerotic CVD, remain still elusive. Thus, this study sought out to investigate sex-specific associations between smoking and measures of arterial stiffness.
Methods and results
Overall, 15,010 participants (7584 men and 7426 women aged 35-74 years) of the Gutenberg Health Study were examined at baseline during 2007-2012. Smoking status, pack-years of smoking, and years since quitting smoking were assessed by a standardized computer-assisted interview. Arterial stiffness and wave reflection were determined by stiffness index (SI) and augmentation index (AI). In the total sample, 45.8% had never smoked, 34.7% were former smokers, and 19.4% were current smokers. Median cumulative smoking exposure was 22.0 pack-years in current male smokers and 16.0 in current female smokers. In general, multivariable linear regression models adjusted for a comprehensive set of confounders revealed that smoking status, pack-years of smoking, and years since quitting smoking were dose-dependently associated with markers of arterial stiffness. In sex-specific analyses, these associations were overall more pronounced in men and SI was stronger related to the male sex, whereas differences between men and women in the case of AI appeared to be less substantial.
Discussion
The present results indicate that chronic smoking is strongly and dose-dependently associated with increased arterial stiffness in a large population-based cohort regardless of sex but with a stronger association in men.

© 2022. The Author(s).

Clin Res Cardiol: 06 Sep 2022; epub ahead of print
Hahad O, Schmitt VH, Arnold N, Keller K, ... Daiber A, Münzel T
Clin Res Cardiol: 06 Sep 2022; epub ahead of print | PMID: 36068365
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Impact:
Abstract

Towards automatic classification of cardiovascular magnetic resonance Task Force Criteria for diagnosis of arrhythmogenic right ventricular cardiomyopathy.

Bourfiss M, Sander J, de Vos BD, Te Riele ASJM, ... Išgum I, Velthuis BK
Background
Arrhythmogenic right ventricular cardiomyopathy (ARVC) is diagnosed according to the Task Force Criteria (TFC) in which cardiovascular magnetic resonance (CMR) imaging plays an important role. Our study aims to apply an automatic deep learning-based segmentation for right and left ventricular CMR assessment and evaluate this approach for classification of the CMR TFC.
Methods
We included 227 subjects suspected of ARVC who underwent CMR. Subjects were classified into (1) ARVC patients fulfilling TFC; (2) at-risk family members; and (3) controls. To perform automatic segmentation, a Bayesian Dilated Residual Neural Network was trained and tested. Performance of automatic versus manual segmentation was assessed using Dice-coefficient and Hausdorff distance. Since automatic segmentation is most challenging in basal slices, manual correction of the automatic segmentation in the most basal slice was simulated (automatic-basal). CMR TFC calculated using manual and automatic-basal segmentation were compared using Cohen\'s Kappa (κ).
Results
Automatic segmentation was trained on CMRs of 70 subjects (39.6 ± 18.1 years, 47% female) and tested on 157 subjects (36.9 ± 17.6 years, 59% female). Dice-coefficient and Hausdorff distance showed good agreement between manual and automatic segmentations (≥ 0.89 and ≤ 10.6 mm, respectively) which further improved after simulated correction of the most basal slice (≥ 0.92 and ≤ 9.2 mm, p < 0.001). Pearson correlation of volumetric and functional CMR measurements was good to excellent (automatic (r = 0.78-0.99, p < 0.001) and automatic-basal (r = 0.88-0.99, p < 0.001) measurements). CMR TFC classification using automatic-basal segmentations was comparable to manual segmentations (κ 0.98 ± 0.02) with comparable diagnostic performance.
Conclusions
Combining automatic segmentation of CMRs with correction of the most basal slice results in accurate CMR TFC classification of subjects suspected of ARVC.

© 2022. The Author(s).

Clin Res Cardiol: 06 Sep 2022; epub ahead of print
Bourfiss M, Sander J, de Vos BD, Te Riele ASJM, ... Išgum I, Velthuis BK
Clin Res Cardiol: 06 Sep 2022; epub ahead of print | PMID: 36066609
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Impact:
Abstract

10-year follow-up of interventional electrophysiology: updated German survey during the COVID-19 pandemic.

Eckardt L, Doldi F, Busch S, Duncker D, ... Steven D, Sommer P
Introduction
This study provides an update of survey-based data providing an overview of interventional electrophysiology over the last decade. Overall infrastructure, procedures, and training opportunities in Germany were assessed.
Methods
By analyzing mandatory quality reports, German cardiology centres performing electrophysiological studies were identified to repeat a questionnaire from 2010 and 2015.
Results
A complete questionnaire was returned by 192 centers performing about 75% of all ablations in Germany in 2020. In the presence of the COVID-19 pandemic, a total of 76.304 procedures including 68.407 ablations were reported representing a 38% increase compared to 2015. The median number of ablations increased from 180 in 2010 to 377 in 2020. AF was the most common arrhythmia ablated (51 vs. 35% in 2010). PVI with radiofrequency point-by-point ablation (64%) and cryo-balloon ablation (34%) were the preferred strategies. Less than 50 (75) PVI were performed by 31% (36%) of all centres. Only 25 and 24% of participating centres fulfilled EHRA and national requirements for training centre accreditation, respectively. There was a high number of EP centres with no fellows (38%). The proportion of female fellows in EP increased from 26% in 2010 to 33% in 2020.
Conclusion
Comparing 2020, 2010 and 2015, an increasing number of EP centres and procedures were registered. In 2020, more than every second ablation was for therapy of AF. In the presence of an increasing number of procedures, training opportunities were still limited, and most centres did not fulfill recommended EHRA or national requirements for accreditation.

© 2022. The Author(s).

Clin Res Cardiol: 06 Sep 2022; epub ahead of print
Eckardt L, Doldi F, Busch S, Duncker D, ... Steven D, Sommer P
Clin Res Cardiol: 06 Sep 2022; epub ahead of print | PMID: 36066610
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Impact:
Abstract

Should HFrEF patients with NYHA class II expect benefit from CCM therapy? Results from the MAINTAINED observational study.

Fastner C, Yuecel G, Hetjens S, Rudic B, ... Duerschmied D, Kuschyk J
Background
Cardiac contractility modulation (CCM) is an FDA-approved device therapy for patients with refractory systolic heart failure and normal QRS width. Randomized trials demonstrated benefits of CCM primarily for patients with severe heart failure (> NYHA class II).
Purpose
To better understand individualized indication in clinical practice, we compared the effect of CCM in patients with baseline NYHA class II vs. NYHA class III or ambulatory IV over the 5-year period in our large clinical registry (MAINTAINED Observational Study).
Methods
Changes in NYHA class, left ventricular ejection fraction (LVEF), tricuspid annular plane systolic excursion (TAPSE), NT-proBNP level, and KDIGO chronic kidney disease stage were compared as functional parameters. In addition, mortality within 3 years was compared with the prediction of the Meta-Analysis Global Group in Chronic heart failure risk score.
Results
A total of 172 patients were included in the analyses (10% with NYHA class II). Only patients with NYHA class III/IV showed a significant improvement in NYHA class over 5 years of CCM (II: 0.1 ± 0.6; p = 0.96 vs. III/IV: - 0.6 ± 0.6; p < 0.0001). In both groups, LVEF improved significantly (II: 4.7 ± 8.3; p = 0.0072 vs. III/IV: 7.0 ± 10.7%; p < 0.0001), while TAPSE improved significantly only in NYHA class III/IV patients (II: 2.2 ± 1.6; p = 0.20 vs. III/IV: 1.8 ± 5.2 mm; p = 0.0397). LVEF improvement was comparable in both groups over 5 years of CCM (p = 0.83). NYHA class II patients had significantly lower NT-proBNP levels at baseline (858 [175/6887] vs. 2632 [17/28830] ng/L; p = 0.0044), which was offset under therapy (399 [323/1497] vs. 901 [13/18155] ng/L; p = 0.61). Actual 3-year mortality was 17 and 26% vs. a predicted mortality of 31 and 42%, respectively (p = 0.0038 for NYHA class III/IV patients).
Conclusions
NYHA class III/IV patients experienced more direct and extensive functional improvements with CCM and a survival benefit compared with the predicted risk. However, our data suggest that NYHA class II patients may also benefit from the sustained positive effects of LVEF improvement.

© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.

Clin Res Cardiol: 03 Sep 2022; epub ahead of print
Fastner C, Yuecel G, Hetjens S, Rudic B, ... Duerschmied D, Kuschyk J
Clin Res Cardiol: 03 Sep 2022; epub ahead of print | PMID: 36056955
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Impact:
Abstract

Bailout left atrial appendage occluder for pulmonary vein isolation and electrical cardioversion in patients with atrial fibrillation and left atrial appendage thrombus: a pilot study.

Tsai CF, Huang PS, Chiu FC, Chen JJ, ... Hwang JJ, Tsai CT
Background
Cardioversion and catheter-based circumferential pulmonary vein isolation (CPVI) are established rhythm control treatment strategies for patients with atrial fibrillation (AF). However, these treatments are contraindicated for AF patients with a left atrial appendage (LAA) thrombus.
Methods
We conducted the first-in-man case series study to evaluate the feasibility and safety of performing cardioversion or CPVI in AF patients with LAA thrombus immediately after implantation of LAA Occluder (LAAO) in a combined procedure. In our multi-center LAAO registry of 310 patients, 27 symptomatic and drug-refractory AF patients underwent a combined procedure of LAAO and CPVI, among whom 10 (mean age 68 ± 16 years, 6 men) having anticoagulant-resistant LAA thrombus received a bailout procedure of LAAO implantation first then CPVI, and the other 17 patients without LAA thrombus received CPVI first then LAAO for comparison.
Results
The mean CHA2DS2-VASc score and HAS-BLED score were comparable between these two groups. In patients with LAA thrombus, we put carotid filters and did a no-touch technique, neither advancing the wire and sheath into the LAA nor performing LAA angiography. After LAAO implantation, the connecting cable was still connected to the occluder when cardioversion was performed. During CPVI, the occluder location was registered in the LA geometry by three-dimensional mapping to guide the catheter not to touch the LAAO. The procedure was successful in all the patients without intra-procedural complications. After a mean follow-up of 1.7 ± 0.7 years, there was no device embolization, peri-device leak ≧ 5 mm or stroke event in both groups. The AF recurrence rate was also similar between the two groups (P = 0.697).
Conclusion
We demonstrated that cardioversion or CPVI is doable in symptomatic AF patients with LAA thrombus if LAA was occluded ahead as a bailout procedure.

© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.

Clin Res Cardiol: 02 Sep 2022; epub ahead of print
Tsai CF, Huang PS, Chiu FC, Chen JJ, ... Hwang JJ, Tsai CT
Clin Res Cardiol: 02 Sep 2022; epub ahead of print | PMID: 36056218
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Impact:
Abstract

New-onset aortic dilatation in the population: a quarter-century follow-up.

Cuspidi C, Facchetti R, Bombelli M, Seravalle G, Grassi G, Mancia G
Background
Aortic size tends to increase with aging but the extent of this dynamic process has not been evaluated in long-term longitudinal population-based studies. We investigated the incidence of new-onset aortic root (AR) dilatation and its principal correlates among middle-aged adults over a 25-year time period.
Methods
A total of 471 participants with measurable echocardiographic parameters at baseline and after a 25-year follow-up were included in the analysis. Sex-specific upper limits of normality for absolute AR diameter, AR diameter indexed to body surface area (BSA) and to height were derived from healthy normotensive PAMELA participants.
Results
New AR dilatation occurred in 7.4% (AR/BSA), 9.1% (AR/height) and 14.6% (absolute AR), respectively. According to the AR/height index, the risk of new dilation was similar in men and women. As for echocardiographic parameters, baseline AR diameter emerged as a key predictor of AR dilation, regardless of the diagnostic criteria and the 10-year change in LVMI was positively associated to new AR/height dilatation. No significant relationship was observed between baseline office and ambulatory systolic/diastolic blood pressure or their changes over time with incident AR dilatation. Baseline and the 25-year change in 24-h pulse pressure were negatively related to new AR dilatation.
Conclusions
The incidence of AR dilatation from mid to late adulthood occurs in a small but clinically relevant fraction of participants and is unaffected by both office and out-office BP. It is significant related to baseline AR diameter and to the 25-year change in LVMI. Our data suggest that echocardiography performed in middle-aged individuals of both sexes may identify those at increased risk of future AR dilatation; moreover, preventing LVH may reduce the risk of progressive AR enlargement.

© 2022. The Author(s).

Clin Res Cardiol: 26 Aug 2022; epub ahead of print
Cuspidi C, Facchetti R, Bombelli M, Seravalle G, Grassi G, Mancia G
Clin Res Cardiol: 26 Aug 2022; epub ahead of print | PMID: 36028778
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Impact:
Abstract

Third dose of the BNT162b2 vaccine in cardiothoracic transplant recipients: predictive factors for humoral response.

Costard-Jäckle A, Schramm R, Fischer B, Rivinius R, ... Knabbe C, Gummert J
Background
We report the results of a prospective study on the immunogenicity of a 3rd dose of BNT162b2 in thoracic organ recipients with no or minimal response following a two-dose BNT162b2 vaccination scheme.
Methods
A total of 243 transplant recipients received a homologue 3rd dose. Anti-SARS-CoV2-immunoglobulins (IgGs) were monitored immediately before (T1), 4 weeks (T2) as well as 2 and 4 months after the 3rd dose. Neutralizing antibody capacity (NAC) was determined at T2. To reveal predictors for detectable humoral response, patients were divided into a positive response group (n = 129) based on the combined criteria of IgGs and NAC above the defined cut-offs at T2-and a group with negative response (n = 114), with both, IgGs and NAC beyond the cut-offs.
Results
The 3rd dose induced a positive humoral response in 53% of patients at T2, 47% were still non-responsive. Sero-positivity was significantly stronger in patients who presented with weak, but detectable IgGs already prior to the booster (T1), when compared to those with no detectable response at T1. Multivariable analysis identified age > 55 years, a period since transplantation < 2 years, a reduced glomerular filtration rate, a triple immunosuppressive regimen, and the use of tacrolimus and of mycophenolate as independent risk factors for lack of humoral response.
Conclusions
Our data indicate that a lack of immunogenicity is linked to the type and extent of maintenance immunosuppression. The necessity of the cumulative immunosuppressive regimen might individually be questioned and possibly be reduced to enhance the chance of an immune response following an additional booster dose.

© 2022. The Author(s).

Clin Res Cardiol: 22 Aug 2022; epub ahead of print
Costard-Jäckle A, Schramm R, Fischer B, Rivinius R, ... Knabbe C, Gummert J
Clin Res Cardiol: 22 Aug 2022; epub ahead of print | PMID: 35994091
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Impact:
Abstract

Venting during venoarterial extracorporeal membrane oxygenation.

Lüsebrink E, Binzenhöfer L, Kellnar A, Müller C, ... Massberg S, Orban M
Cardiogenic shock and cardiac arrest contribute pre-dominantly to mortality in acute cardiovascular care. Here, veno-arterial extracorporeal membrane oxygenation (VA-ECMO) has emerged as an established therapeutic option for patients suffering from these life-threatening entities. VA-ECMO provides temporary circulatory support until causative treatments are effective and enables recovery or serves as a bridging strategy to surgical ventricular assist devices, heart transplantation or decision-making. However, in-hospital mortality rate in this treatment population is still around 60%. In the recently published ARREST trial, VA-ECMO treatment lowered mortality rate in patients with ongoing cardiac arrest due to therapy refractory ventricular fibrillation compared to standard advanced cardiac life support in selected patients. Whether VA-ECMO can reduce mortality compared to standard of care in cardiogenic shock has to be evaluated in the ongoing prospective randomized studies EURO-SHOCK (NCT03813134) and ECLS-SHOCK (NCT03637205). As an innate drawback of VA-ECMO treatment, the retrograde aortic flow could lead to an elevation of left ventricular (LV) afterload, increase in LV filling pressure, mitral regurgitation, and elevated left atrial pressure. This may compromise myocardial function and recovery, pulmonary hemodynamics-possibly with concomitant pulmonary congestion and even lung failure-and contribute to poor outcomes in a relevant proportion of treated patients. To overcome these detrimental effects, a multitude of venting strategies are currently engaged for both preventive and emergent unloading. This review aims to provide a comprehensive and structured synopsis of existing venting modalities and their specific hemodynamic characteristics. We discuss in detail the available data on outcome categories and complication rates related to the respective venting option.

© 2022. The Author(s).

Clin Res Cardiol: 20 Aug 2022; epub ahead of print
Lüsebrink E, Binzenhöfer L, Kellnar A, Müller C, ... Massberg S, Orban M
Clin Res Cardiol: 20 Aug 2022; epub ahead of print | PMID: 35986750
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Impact:
Abstract

Genetic and modifiable risk factors combine multiplicatively in common disease.

Pang S, Yengo L, Nelson CP, Bourier F, ... Visscher PM, Schunkert H
Background
The joint contribution of genetic and environmental exposures to noncommunicable diseases is not well characterized.
Objectives
We modeled the cumulative effects of common risk alleles and their prevalence variations with classical risk factors.
Methods
We analyzed mathematically and statistically numbers and effect sizes of established risk alleles for coronary artery disease (CAD) and other conditions.
Results
In UK Biobank, risk alleles counts in the lowest (175.4) and highest decile (205.7) of the distribution differed by only 16.9%, which nevertheless increased CAD prevalence 3.4-fold (p < 0.01). Irrespective of the affected gene, a single risk allele multiplied the effects of all others carried by a person, resulting in a 2.9-fold stronger effect size in the top versus the bottom decile (p < 0.01) and an exponential increase in risk (R > 0.94). Classical risk factors shifted effect sizes to the steep upslope of the logarithmic function linking risk allele numbers with CAD prevalence. Similar phenomena were observed in the Estonian Biobank and for risk alleles affecting diabetes mellitus, breast and prostate cancer.
Conclusions
Alleles predisposing to common diseases can be carried safely in large numbers, but few additional ones lead to sharp risk increments. Here, we describe exponential functions by which risk alleles combine interchangeably but multiplicatively with each other and with modifiable risk factors to affect prevalence. Our data suggest that the biological systems underlying these diseases are modulated by hundreds of genes but become only fragile when a narrow window of total risk, irrespective of its genetic or environmental origins, has been passed.

© 2022. The Author(s).

Clin Res Cardiol: 20 Aug 2022; epub ahead of print
Pang S, Yengo L, Nelson CP, Bourier F, ... Visscher PM, Schunkert H
Clin Res Cardiol: 20 Aug 2022; epub ahead of print | PMID: 35987817
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Impact:
Abstract

Concomitant mitral regurgitation in patients with low-gradient aortic stenosis: an analysis from the German Aortic Valve Registry.

Alushi B, Ensminger S, Herrmann E, Balaban Ü, ... Frerker C, Lauten A
Background
Patients with severe aortic stenosis (AS) frequently presented mitral regurgitation (MR), which may interfere with the standard echocardiographic measurements of mean pressure gradient (MPG), flow velocity, and aortic valve area (AVA).
Aims
Herein we investigated the prevalence and severity of MR in patients with severe AS and its role on the accuracy of the standard echocardiographic parameters of AS quantification.
Methods
Of all patients with severe AS undergoing transcatheter or surgical aortic valve replacement enrolled in the German Aortic Registry from 2011 to 2017, 119,641 were included in this study. The population was divided based on the values of left ventricular ejection fraction ([LVEF] > 50%, LVEF 31-50%, and LVEF ≤ 30%] and AVA (0.80 to ≤ 1.00 cm2, 0.60 to < 0.80 cm2, 0.40 to < 0.60 cm2, and 0.20 to < 0.40 cm2).
Results
Overall, 77,890 (65%) patients with mild to-moderate and 4262 (4%) with severe MR were compared with 37,489 (31%) patients without MR. Patients with mild-to-moderate and severe MR presented significantly lower mPG (ΔmPG [95%CI] - 1.694 mmHg [- 2.123 to - 1.265], p < 0.0001 and - 6.954 mmHg [- 7.725 to - 6.183], p < 0.0001, respectively), that increased with LVEF impairment. Conversely, AVA did not differ (severe versus no MR: ΔAVA [95%CI]: - 0.007cm2 [- 0.023 to 0.009], p = 0.973). Increasing MR severity was associated with significant mPG reduction throughout all AVA strata, causing a low-gradient pattern, that manifested since the early stages of severe AS (LVEF > 50%: AVA 0.80 to 1.00 cm2; LVEF 31-50%: AVA 0.60 to 0.80 cm2).
Conclusions
In patients with severe AS, concomitant MR is common, contributes to the onset of a low-gradient AS pattern, and affects the diagnostic accuracy of flow-dependent AVA measurements. In this setting, a multimodality, AVA-centric approach should be implemented. In patients with severe aortic stenosis, concomitant mitral regurgitation contributes to the onset of a low-gradient pattern, warranting a multimodality, and AVA-centric diagnostic approach.

© 2022. The Author(s).

Clin Res Cardiol: 19 Aug 2022; epub ahead of print
Alushi B, Ensminger S, Herrmann E, Balaban Ü, ... Frerker C, Lauten A
Clin Res Cardiol: 19 Aug 2022; epub ahead of print | PMID: 35984497
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Impact:
Abstract

Clinical characteristics, causes and predictors of outcomes in patients with in-hospital cardiac arrest: results from the SURVIVE-ARREST study.

Hannen LEM, Toprak B, Weimann J, Mahmoodi B, ... Zengin-Sahm E, Becher PM
Introduction
In-hospital cardiac arrest (IHCA) is acutely life-threatening and remains associated with high mortality and morbidity. Identifying predictors of mortality after IHCA would help to guide acute therapy.
Methods
We determined patient characteristics and independent predictors of 30-day in-hospital mortality, neurological outcome, and discharge/referral pathways in patients experiencing IHCA in a large tertiary care hospital between January 2014 and April 2017. Multivariable Cox regression model was fitted to assess predictors of outcomes.
Results
A total of 368 patients with IHCA were analysed (median age 73 years (interquartile range 65-78), 123 (33.4%) women). Most patients (45.9%) had an initial non-shockable rhythm and shockable rhythms were found in 20.9%; 23.6% of patients suffered from a recurrent episode of cardiac arrest. 172/368 patients died within 30 days (46.7%). Of 196/368 patients discharged alive after IHCA, the majority (72.9%, n = 143) had a good functional neurological outcome (modified Rankin Scale ≤ 3 points). In the multivariable analysis, return of spontaneous circulation without mechanical circulatory support (hazard ratio (HR) 0.36, 95% confidence interval (CI) 0.21-0.64), invasive coronary angiography and/or percutaneous intervention (HR 0.56, 95% CI 0.34-0.92), and antibiotic therapy (HR 0.87, 95% CI 0.83-0.92) were associated with a lower risk of 30-day in hospital mortality.
Conclusion
In the present study, IHCA was survived in ~ 50% in a tertiary care hospital, although only a minority of patients presented with shockable rhythms. The majority of IHCA survivors (~ 70%) had a good neurological outcome. Recovery of spontaneous circulation and presence of treatable acute causes of the arrest are associated with better survival. Clinical Characteristics, Causes and Predictors of Outcomes in Patients with In-Hospital Cardiac Arrest: Results from the SURVIVE-ARREST Study.
Abbreviations
CPR, cardiopulmonary resuscitation; IHCA, In-hospital cardiac arrest; MCS, mechanical circulatory support; PCI, percutaneous coronary intervention; ROSC, return of spontaneous circulation; SBP, systolic blood pressure.

© 2022. The Author(s).

Clin Res Cardiol: 17 Aug 2022; epub ahead of print
Hannen LEM, Toprak B, Weimann J, Mahmoodi B, ... Zengin-Sahm E, Becher PM
Clin Res Cardiol: 17 Aug 2022; epub ahead of print | PMID: 35978110
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Impact:
Abstract

Effects of the COVID-19 pandemic on acute coronary syndromes in Germany during the first wave: the COVID-19 collateral damage study.

Zeymer U, Ahmadli V, Schneider S, Werdan K, ... Bollmann A, Thiele H
Background
Reports about the influence of the COVID-19 pandemic on the number of hospital admissions and in-hospital mortality during the first wave between March and May 2020 showed conflicting results and are limited by single-center or limited regional multicenter datasets. Aim of this analysis covering all German federal states was the comprehensive description of hospital admissions and in-hospital mortality during the first wave of the COVID-19 pandemic.
Methods and results
We conducted an observational study on hospital routine data (§21 KHEntgG) and included patients with the main diagnosis of acute myocardial infarction (ICD 21 and ICD 22). A total of 159 hospitals included 36,329 patients in the database, with 12,497 patients admitted with ST-elevation myocardial infarction (STEMI) and 23,832 admitted with non-ST-elevation myocardial infarction (NSTEMI). There was a significant reduction in the number of patients admitted with STEMI (3748 in 2020, 4263 in 2019 and 4486 in 2018; p < 0.01) and NSTEMI (6957 in 2020, 8437 in 2019 and 8438 in 2020; p < 0.01). These reductions were different between the Federal states of Germany. Percutaneous coronary intervention was performed more often in 2020 than in 2019 (odds ratio 1.13, 95% confidence interval [CI] 1.06-1.21) and 2018 (odds ratio 1.20, 95% CI 1.12-1.29) in NSTEMI and more often than in 2018 (odds ratio 1.26, 95% CI 1.10-1.43) in STEMI. The in-hospital mortality did not differ between the years for STEMI and NSTEMI, respectively.
Conclusions
In this large representative sample size of hospitals in Germany, we observed significantly fewer admissions for NSTEMI and STEMI during the first COVID-19 wave, while quality of in-hospital care and in-hospital mortality were not affected. Admissions for STEMI and NSTEMI during the months March to May over 3 years and corresponding in-hospital mortality for patients with STEMI and NSTEMI in 159 German hospitals. (p-value for admissions 2020 versus 2019 and 2018: < 0.01; p-value for mortality: n.s.).

© 2022. The Author(s).

Clin Res Cardiol: 17 Aug 2022; epub ahead of print
Zeymer U, Ahmadli V, Schneider S, Werdan K, ... Bollmann A, Thiele H
Clin Res Cardiol: 17 Aug 2022; epub ahead of print | PMID: 35978111
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Abstract

Heterogeneity of outcomes within diabetic patients with atrial fibrillation on edoxaban: a sub-analysis from the ETNA-AF Europe registry.

Patti G, Pecen L, Casalnuovo G, Manu MC, Kirchhof P, De Caterina R
Background
Recent data have suggested that insulin-requiring diabetes mostly contributes to the overall increase of thromboembolic risk in patients with atrial fibrillation (AF) on warfarin. We evaluated the prognostic role of a different diabetes status on clinical outcome in a large cohort of AF patients treated with edoxaban.
Methods
We accessed individual patients\' data from the prospective, multicenter, ETNA-AF Europe Registry. We compared the rates of ischemic stroke/transient ischemic attack (TIA)/systemic embolism, myocardial infarction (MI), major bleeding and all-cause death at 2 years according to diabetes status.
Results
Out of an overall population of 13,133 patients, 2885 had diabetes (22.0%), 605 of whom (21.0%) were on insulin. The yearly incidence of ischemic stroke/TIA/systemic embolism was 0.86% in patients without diabetes, 0.87% in diabetic patients not receiving insulin (p = 0.92 vs no diabetes) and 1.81% in those on insulin (p = 0.002 vs no diabetes; p = 0.014 vs diabetes not on insulin). The annual rates of MI and major bleeding were 0.40%, 0.43%, 1.04% and 0.90%, 1.10% and 1.71%, respectively. All-cause yearly mortality was 3.36%, 5.02% and 8.91%. At multivariate analysis, diabetes on insulin was associated with a higher rate of ischemic stroke/TIA/systemic embolism [adjusted HR 2.20, 95% CI 1.37-3.54, p = 0.0011 vs no diabetes + diabetes not on insulin] and all-cause death [aHR 2.13 (95% CI 1.68-2.68, p < 0.0001 vs no diabetes]. Diabetic patients not on insulin had a higher mortality [aHR 1.32 (1.11-1.57), p = 0.0015], but similar incidence of stroke/TIA/systemic embolism, MI and major bleeding, vs those without diabetes.
Conclusions
In a real-world cohort of AF patients on edoxaban, diabetes requiring insulin therapy, rather than the presence of diabetes per se, appears to be an independent factor affecting the occurrence of thromboembolic events during follow-up. Regardless of the diabetes type, diabetic patients had a lower survival compared with those without diabetes.

© 2022. The Author(s).

Clin Res Cardiol: 17 Aug 2022; epub ahead of print
Patti G, Pecen L, Casalnuovo G, Manu MC, Kirchhof P, De Caterina R
Clin Res Cardiol: 17 Aug 2022; epub ahead of print | PMID: 35976428
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Abstract

Pulmonary embolism response team (PERT) implementation and its clinical value across countries: a scoping review and meta-analysis.

Hobohm L, Farmakis IT, Keller K, Scibior B, ... Ahrens I, Konstantinides S
Background
Over the last years, multidisciplinary pulmonary embolism response teams (PERTs) have emerged to encounter the increasing variety and complexity in the management of acute pulmonary embolism (PE). We aimed to systematically investigate the composition and added clinical value of PERTs.
Methods
We searched PubMed, CENTRAL and Web of Science until January 2022 for articles designed to describe the structure and function of PERTs. We performed a random-effects meta-analysis of controlled studies (PERT vs. pre-PERT era) to investigate the impact of PERTs on clinical outcomes and advanced therapies use.
Results
We included 22 original studies and four surveys. Overall, 31.5% of patients with PE were evaluated by PERT referred mostly by emergency departments (59.4%). In 11 single-arm studies (1532 intermediate-risk and high-risk patients evaluated by PERT) mortality rate was 10%, bleeding rate 9% and length of stay 7.3 days [95% confidence interval (CI) 5.7-8.9]. In nine controlled studies there was no difference in mortality [risk ratio (RR) 0.89, 95% CI 0.67-1.19] by comparing pre-PERT with PERT era. When analysing patients with intermediate or high-risk class only, the effect estimate for mortality tended to be lower for patients treated in the PERT era compared to those treated in the pre-PERT era (RR 0.71, 95% CI 0.45-1.12). The use of advanced therapies was higher (RR 2.67, 95% CI 1.29-5.50) and the in-hospital stay shorter (mean difference - 1.6 days) in PERT era compared to pre-PERT era.
Conclusions
PERT implementation led to greater use of advanced therapies and shorter in-hospital stay. Our meta-analysis did not show a survival benefit in patients with PE since PERT implementation. Large prospective studies are needed to further explore the impact of PERTs on clinical outcomes.
Registration
Open Science Framework 10.17605/OSF.IO/SBFK9.

© 2022. The Author(s).

Clin Res Cardiol: 17 Aug 2022; epub ahead of print
Hobohm L, Farmakis IT, Keller K, Scibior B, ... Ahrens I, Konstantinides S
Clin Res Cardiol: 17 Aug 2022; epub ahead of print | PMID: 35976429
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Abstract

Comorbidities complicating heart failure: changes over the last 15 years.

Screever EM, van der Wal MHL, van Veldhuisen DJ, Jaarsma T, ... de Boer RA, Meijers WC
Aims
Management of comorbidities represents a critical step in optimal treatment of heart failure (HF) patients. However, minimal attention has been paid whether comorbidity burden and their prognostic value changes over time. Therefore, we examined the association between comorbidities and clinical outcomes in HF patients between 2002 and 2017.
Methods and results
The 2002-HF cohort consisted of patients from The Coordinating Study Evaluating Outcomes of Advising and Counseling in Heart Failure (COACH) trial (n = 1,032). The 2017-HF cohort were outpatient HF patients enrolled after hospitalization for HF in a tertiary referral academic hospital (n = 382). Kaplan meier and cox regression analyses were used to assess the association of comorbidities with HF hospitalization and all-cause mortality. Patients from the 2017-cohort were more likely to be classified as HF with preserved ejection fraction (24 vs 15%, p < 0.001), compared to patients from the 2002-cohort. Comorbidity burden was comparable between both cohorts (mean of 3.9 comorbidities per patient) and substantially increased with age. Higher comorbidity burden was significantly associated with a comparable increased risk for HF hospitalization and all-cause mortality (HR 1.12 [1.02-1.22] and HR 1.18 [1.05-1.32]), in the 2002- and 2017-cohort respectively. When assessing individual comorbidities, obesity yielded a statistically higher prognostic effect on outcome in the 2017-cohort compared to the 2002-HF cohort (p for interaction 0.026).
Conclusion
Despite major advances in HF treatment over the past decades, comorbidity burden remains high in HF and influences outcome to a large extent. Obesity emerges as a prominent comorbidity, and efforts should be made for prevention and treatment. Created with BioRender.com.

© 2022. The Author(s).

Clin Res Cardiol: 17 Aug 2022; epub ahead of print
Screever EM, van der Wal MHL, van Veldhuisen DJ, Jaarsma T, ... de Boer RA, Meijers WC
Clin Res Cardiol: 17 Aug 2022; epub ahead of print | PMID: 35976430
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Abstract

Heart rate variability and atrial fibrillation in the general population: a longitudinal and Mendelian randomization study.

Geurts S, Tilly MJ, Arshi B, Stricker BHC, ... Ikram MA, Kavousi M
Background
Sex differences and causality of the association between heart rate variability (HRV) and atrial fibrillation (AF) in the general population remain unclear.
Methods
12,334 participants free of AF from the population-based Rotterdam Study were included. Measures of HRV including the standard deviation of normal RR intervals (SDNN), SDNN corrected for heart rate (SDNNc), RR interval differences (RMSSD), RMSSD corrected for heart rate (RMSSDc), and heart rate were assessed at baseline and follow-up examinations. Joint models, adjusted for cardiovascular risk factors, were used to determine the association between longitudinal measures of HRV with new-onset AF. Genetic variants for HRV were used as instrumental variables in a Mendelian randomization (MR) analysis using genome-wide association studies (GWAS) summary-level data.
Results
During a median follow-up of 9.4 years, 1302 incident AF cases occurred among 12,334 participants (mean age 64.8 years, 58.3% women). In joint models, higher SDNN (fully-adjusted hazard ratio (HR), 95% confidence interval (CI) 1.24, 1.04-1.47, p = 0.0213), and higher RMSSD (fully-adjusted HR, 95% CI 1.33, 1.13-1.54, p = 0.0010) were significantly associated with new-onset AF. Sex-stratified analyses showed that the associations were mostly prominent among women. In MR analyses, a genetically determined increase in SDNN (odds ratio (OR), 95% CI 1.60, 1.27-2.02, p = 8.36 × 10-05), and RMSSD (OR, 95% CI 1.56, 1.31-1.86, p = 6.32 × 10-07) were significantly associated with an increased odds of AF.
Conclusion
Longitudinal measures of uncorrected HRV were significantly associated with new-onset AF, especially among women. MR analyses supported the causal relationship between uncorrected measures of HRV with AF. Our findings indicate that measures to modulate HRV might prevent AF in the general population, in particular in women. AF; atrial fibrillation, GWAS; genome-wide association study, IVW; inverse variance weighted, MR; Mendelian randomization, MR-PRESSO; MR-egger and mendelian randomization pleiotropy residual sum and outlier, RMSSD; root mean square of successive RR interval differences, RMSSDc; root mean square of successive RR interval differences corrected for heart rate, SDNN; standard deviation of normal to normal RR intervals, SDNNc; standard deviation of normal to normal RR intervals corrected for heart rate, WME; weighted median estimator. aRotterdam Study n=12,334 bHRV GWAS n=53,174 cAF GWAS n=1,030,836.

© 2022. The Author(s).

Clin Res Cardiol: 13 Aug 2022; epub ahead of print
Geurts S, Tilly MJ, Arshi B, Stricker BHC, ... Ikram MA, Kavousi M
Clin Res Cardiol: 13 Aug 2022; epub ahead of print | PMID: 35962833
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Abstract

Relationship between non-invasively detected liver fibrosis and in-hospital outcomes in patients with acute coronary syndrome undergoing PCI.

Biccirè FG, Barillà F, Sammartini E, Dacierno EM, Tanzilli G, Pastori D
Background
Patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) still experience a high rate of in-hospital complications. Liver fibrosis (LF) is a risk factor for mortality in the general population. We investigated whether the presence of LF detected by the validated fibrosis 4 (FIB-4) score may indicate ACS patients at higher risk of poor outcome.
Methods
In the prospective ongoing REAl-world observationaL rEgistry of Acute Coronary Syndrome (REALE-ACS), LF was defined by a FIB-4 score > 3.25. We repeated the analysis using an APRI score > 0.7. The primary endpoint was in-hospital adverse events (AEs) including a composite of in-hospital cardiogenic shock, PEA/asystole, acute pulmonary edema and death.
Results
A total of 469 consecutive ACS consecutive patients were enrolled. Overall, 21.1% of patients had a FIB-4 score > 3.25. Patients with LF were older, less frequently on P2Y12 inhibitors (p = 0.021) and admitted with higher serum levels of white blood cells (p < 0.001), neutrophils to lymphocytes ratio (p < 0.001), C-reactive protein (p = 0.013), hs-TnT (p < 0.001), creatine-kinase MB (p < 0.001), D-Dimer levels (p < 0.001). STEMI presentation and higher Killip class/GRACE score were more common in the LF group (p < 0.001). 71 patients experienced 110 AEs. At the multivariate analysis including clinical and laboratory risk factors, FIB-4 > 3.25 (OR 3.1, 95%CI 1.4-6.9), admission left ventricular ejection fraction% below median (OR 9.2, 95%CI 3.9-21.7) and Killip class ≥ II (OR 6.3, 95%CI 2.2-18.4) were the strongest independent predictors of in-hospital AEs. Similar results were obtained using the APRI score.
Conclusion
LF detected by FIB-4 score > 3.25 was associated with more severe ACS presentation and worse in-hospital AEs irrespective of clinical and laboratory variables.

© 2022. The Author(s).

Clin Res Cardiol: 11 Aug 2022; epub ahead of print
Biccirè FG, Barillà F, Sammartini E, Dacierno EM, Tanzilli G, Pastori D
Clin Res Cardiol: 11 Aug 2022; epub ahead of print | PMID: 35951109
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Abstract

Atrial fibrillation patterns and their cardiovascular risk profiles in the general population: the Rotterdam study.

Tilly MJ, Lu Z, Geurts S, Ikram MA, ... de Groot NMS, Kavousi M
Background
Clinical guidelines categorize atrial fibrillation (AF) based on the temporality of AF events. Due to its dependence on event duration, this classification is not applicable to population-based cohort settings. We aimed to develop a simple and standardized method to classify AF patterns at population level. Additionally, we compared the longitudinal trajectories of cardiovascular risk factors preceding the AF patterns, and between men and women.
Methods
Between 1990 and 2014, participants from the population-based Rotterdam study were followed for AF status, and categorized into \'single-documented AF episode\', \'multiple-documented AF episodes\', or \'long-standing persistent AF\'. Using repeated measurements we created linear mixed-effects models to assess the longitudinal evolution of risk factors prior to AF diagnosis.
Results
We included 14,061 participants (59.1% women, mean age 65.4 ± 10.2 years). After a median follow-up of 9.4 years (interquartile range 8.27), 1,137 (8.1%) participants were categorized as \'single-documented AF episode\', 208 (1.5%) as \'multiple-documented AF episodes\', and 57 (0.4%) as \'long-standing persistent AF\'. In men, we found poorer trajectories of weight and waist circumference preceding \'long-standing persistent AF\' as compared to the other patterns. In women, we found worse trajectories of all risk factors between \'long-standing persistent AF\' and the other patterns.
Conclusion
We developed a standardized method to classify AF patterns in the general population. Participants categorized as \'long-standing persistent AF\' showed poorer trajectories of cardiovascular risk factors prior to AF diagnosis, as compared to the other patterns. Our findings highlight sex differences in AF pathophysiology and provide insight into possible risk factors of AF patterns.

© 2022. The Author(s).

Clin Res Cardiol: 10 Aug 2022; epub ahead of print
Tilly MJ, Lu Z, Geurts S, Ikram MA, ... de Groot NMS, Kavousi M
Clin Res Cardiol: 10 Aug 2022; epub ahead of print | PMID: 35948741
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Impact:
Abstract

Prognostic model for atrial fibrillation after cardiac surgery: a UK cohort study.

Chung SC, O\'Brien B, Lip GYH, Fields KG, ... Watkinson P, Providencia R
Objective
To develop a validated clinical prognostic model to determine the risk of atrial fibrillation after cardiac surgery as part of the PARADISE project (NIHR131227).
Methods
Prospective cohort study with linked electronic health records from a cohort of 5.6 million people in the United Kingdom Clinical Practice Research Datalink from 1998 to 2016. For model development, we considered a priori candidate predictors including demographics, medical history, medications, and clinical biomarkers. We evaluated associations between covariates and the AF incidence at the end of follow-up using logistic regression with the least absolute shrinkage and selection operator. The model was validated internally with the bootstrap method; subsequent performance was examined by discrimination quantified with the c-statistic and calibration assessed by calibration plots. The study follows TRIPOD guidelines.
Results
Between 1998 and 2016, 33,464 patients received cardiac surgery among the 5,601,803 eligible individuals. The final model included 13-predictors at baseline: age, year of index surgery, elevated CHA2DS2-VASc score, congestive heart failure, hypertension, acute coronary syndromes, mitral valve disease, ventricular tachycardia, valve surgery, receiving two combined procedures (e.g., valve replacement + coronary artery bypass grafting), or three combined procedures in the index procedure, statin use, and ethnicity other than white or black (statins and ethnicity were protective). This model had an optimism-corrected C-statistic of 0.68 both for the derivation and validation cohort. Calibration was good.
Conclusions
We developed a model to identify a group of individuals at high risk of AF and adverse outcomes who could benefit from long-term arrhythmia monitoring, risk factor management, rhythm control and/or thromboprophylaxis.

© 2022. The Author(s).

Clin Res Cardiol: 05 Aug 2022; epub ahead of print
Chung SC, O'Brien B, Lip GYH, Fields KG, ... Watkinson P, Providencia R
Clin Res Cardiol: 05 Aug 2022; epub ahead of print | PMID: 35930034
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Impact:
Abstract

Medical and cardio-vascular emergency department visits during the COVID-19 pandemic in 2020: is there a collateral damage? A retrospective routine data analysis.

Slagman A, Pigorsch M, Greiner F, Behringer W, ... Wu YN, Möckel M
Background
In this retrospective routine data analysis, we investigate the number of emergency department (ED) consultations during the COVID-19 pandemic of 2020 in Germany compared to the previous year with a special focus on numbers of myocardial infarction and acute heart failure.
Methods
Aggregated case numbers for the two consecutive years 2019 and 2020 were obtained from 24 university hospitals and 9 non-university hospitals in Germany and assessed by age, gender, triage scores, disposition, care level and by ICD-10 codes including the tracer diagnoses myocardial infarction (I21) and heart failure (I50).
Results
A total of 2,216,627 ED consultations were analyzed, of which 1,178,470 occurred in 2019 and 1,038,157 in 2020. The median deviation in case numbers between 2019 and 2020 was - 14% [CI (- 11)-(- 16)]. After a marked drop in all cases in the first COVID-19 wave in spring 2020, case numbers normalized during the summer. Thereafter starting in calendar week 39 case numbers constantly declined until the end of the year 2020. The decline in case numbers predominantly concerned younger [- 16%; CI (- 13)-(- 19)], less urgent [- 18%; CI (- 12)-(- 22)] and non-admitted cases [- 17%; CI (- 13)-(- 20)] in particular during the second wave. During the entire observation period admissions for chest pain [- 13%; CI (- 21)-2], myocardial infarction [- 2%; CI (- 9)-11] and heart failure [- 2%; CI (- 10)-6] were less affected and remained comparable to the previous year.
Conclusions
ED visits were noticeably reduced during both SARS-CoV-2 pandemic waves in Germany but cardiovascular diagnoses were less affected and no refractory increase was noted. However, long-term effects cannot be ruled out and need to be analysed in future studies.

© 2022. The Author(s).

Clin Res Cardiol: 05 Aug 2022; epub ahead of print
Slagman A, Pigorsch M, Greiner F, Behringer W, ... Wu YN, Möckel M
Clin Res Cardiol: 05 Aug 2022; epub ahead of print | PMID: 35931896
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Abstract

Early response of right-ventricular function to percutaneous mitral valve repair.

Sugiura A, Shamekhi J, Goto T, Spieker M, ... Becher MU, of the Heart Failure Network Rhineland
Background
The change in right-ventricular function (RVF) after transcatheter mitral valve repair is still poorly understood. We assessed the early response of RVF to the MitraClip procedure and its clinical relevance.
Methods
We analyzed consecutive patients who underwent a MitraClip procedure to treat MR between August 2010 and March 2019 in the Heart Failure Network Rhineland registry. RVF was assessed before and after the procedure. Impaired RVF was defined as an RV fractional area change (RVFAC) < 35% or tricuspid annular plane systolic excursion (TAPSE) < 16 mm.
Results
816 eligible patients (77 ± 9 years, 58.5% male) were included in the analysis. Baseline values of RVF were: RVFAC 38.6 (IQR 29.7-46.7) % and TAPSE 17.0 (IQR 14.0-21.0) mm. At a median time of 3 (IQR 2-5) days after the procedure, the RVF remained normal in 34% (n = 274), normalized in 17% (n = 140), deteriorated in 15% (n = 125), and was persistently impaired in 34% (n = 277) of patients. The RVF response was significantly associated with a composite outcome of all-cause mortality and hospitalization due to heart failure within a 2-year follow-up. Compared to stable/normal RVF, the adjusted hazard ratios for the outcome were 1.78 (95% CI 1.10-2.86) for normalized RVF, 1.89 (95% CI 1.34-3.15) for deteriorated RVF, and 2.25 (95% CI 1.47-3.44) for persistently impaired RVF. Changes in TAPSE and RVFAC as continuous variables were significantly correlated with the outcome.
Conclusion
An early change in RVF following transcatheter mitral valve repair is predictive of mortality and hospitalization due to heart failure during follow-up. Early response of RVF after MitraClip and its clinical significance. An acute, early change in RVF can be observed following the MitraClip procedure, which is associated with the risk of mortality and hospitalization for HF.

© 2021. The Author(s).

Clin Res Cardiol: 01 Aug 2022; 111:859-868
Sugiura A, Shamekhi J, Goto T, Spieker M, ... Becher MU, of the Heart Failure Network Rhineland
Clin Res Cardiol: 01 Aug 2022; 111:859-868 | PMID: 34669015
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Impact:
Abstract

COVID-19 vaccination and carditis in children and adolescents: a systematic review and meta-analysis.

Chou OHI, Mui J, Chung CT, Radford D, ... Liu T, Tse G
Background
Coronavirus Disease-2019 (COVID-19) vaccination has been associated with the development of carditis, especially in children and adolescent males. However, the rates of these events in the global setting have not been explored in a systematic manner. The aim of this systematic review and meta-analysis is to investigate the rates of carditis in children and adolescents receiving COVID-19 vaccines.
Methods
PubMed, Embase and several Latin American databases were searched for studies. The number of events, and where available, at-risk populations were extracted. Rate ratios were calculated and expressed as a rate per million doses received. Subgroup analysis based on the dose administered was performed. Subjects ≤ 19 years old who developed pericarditis or myocarditis following COVID-19 vaccination were included.
Results
A total of 369 entries were retrieved. After screening, 39 articles were included. Our meta-analysis found that 343 patients developed carditis after the administration of 12,602,625 COVID-19 vaccination doses (pooled rate per million: 37.76; 95% confidence interval [CI] 23.57, 59.19). The rate of carditis was higher amongst male patients (pooled rate ratio: 5.04; 95% CI 1.40, 18.19) and after the second vaccination dose (pooled rate ratio: 5.60; 95% CI 1.97, 15.89). In 301 cases of carditis (281 male; mean age: 15.90 (standard deviation [SD] 1.52) years old) reported amongst the case series/reports, 261 patients were reported to have received treatment. 97.34% of the patients presented with chest pain. The common findings include ST elevation and T wave abnormalities on electrocardiography. Oedema and late gadolinium enhancement in the myocardium were frequently observed in cardiac magnetic resonance imaging (CMR). The mean length of hospital stay was 3.91 days (SD 1.75). In 298 out of 299 patients (99.67%) the carditis resolved with or without treatment.
Conclusions
Carditis is a rare complication after COVID-19 vaccination across the globe, but the vast majority of episodes are self-limiting with rapid resolution of symptoms within days. Central illustration. Balancing the benefits of vaccines on COVID-19-caused carditis and post-vaccination carditis.

© 2022. The Author(s).

Clin Res Cardiol: 30 Jul 2022; epub ahead of print
Chou OHI, Mui J, Chung CT, Radford D, ... Liu T, Tse G
Clin Res Cardiol: 30 Jul 2022; epub ahead of print | PMID: 35906423
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Impact:
Abstract

Predictive value of the Fibrosis-4 index in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement.

Sudo M, Shamekhi J, Sedaghat A, Aksoy A, ... Tiyerili V, Al-Kassou B
Background
Liver dysfunction is associated with an increased risk of mortality after cardiac interventions. The Fibrosis-4 (FIB-4 index), a marker of hepatic fibrosis, has been associated with a worse prognosis in heart failure. The prognostic relevance of the index in patients undergoing transcatheter aortic valve replacement (TAVR) is unknown. The aim of this study was to evaluate the clinical implications associated with the FIB-4 index in patients undergoing TAVR.
Methods
Between May 2012 and June 2019, 941 patients undergoing TAVR were stratified into a low or high FIB-4 index group, based on a cutoff value that was determined according to a receiver operating characteristic curve predicting 1-year all-cause mortality.
Results
Patients with a high FIB-4 index (n = 480), based on the cutoff value of 1.82, showed higher rates of pulmonary hypertension (43.8% vs. 31.8%, p < 0.01), right-ventricular systolic dysfunction (29.5% vs. 19.2%, p < 0.01) and larger inferior vena cava diameter (1.6 ± 0.6 cm vs. 1.3 ± 0.6 cm, p < 0.01) than patients with a low FIB-4 index (n = 461). Furthermore, a high FIB-4 index was associated with a significantly higher cumulative 1-year all-cause mortality (17.5% vs. 10.2%, p < 0.01) and non-cardiovascular mortality (12.1% vs. 2.5%, p < 0.01), compared to a low FIB-4 index. Multivariable analysis revealed that a high FIB-4 index was independently associated with all-cause mortality (HR: 1.75 [95% CI: 1.18-2.59], p < 0.01).
Conclusions
A high FIB-4 index is associated with right-sided heart overload and an increased risk of mortality in patients undergoing TAVR. The FIB-4 index may be useful as an additional predictor of outcomes in these patients.

© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.

Clin Res Cardiol: 19 Jul 2022; epub ahead of print
Sudo M, Shamekhi J, Sedaghat A, Aksoy A, ... Tiyerili V, Al-Kassou B
Clin Res Cardiol: 19 Jul 2022; epub ahead of print | PMID: 35852581
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Impact:
Abstract

Hypertension urgencies in the SPYRAL HTN-OFF MED Pivotal trial.

Weber MA, Schmieder RE, Kandzari DE, Townsend RR, ... Fahy M, Böhm M
The SPYRAL HTN-OFF MED Pivotal trial ( https://clinicaltrials.gov/ct2/show/NCT02439749 ) demonstrated significant reductions in blood pressure (BP) after renal denervation (RDN) compared to sham control in the absence of anti-hypertensive medications. Prior to the 3-month primary endpoint, medications were immediately reinstated for patients who met escape criteria defined as office systolic BP (SBP) ≥ 180 mmHg or other safety concerns. Our objective was to compare the rate of hypertensive urgencies in RDN vs. sham control patients. Patients were enrolled with office SBP ≥ 150 and < 180 mmHg, office diastolic BP (DBP) ≥ 90 mmHg and mean 24 h SBP ≥ 140 and < 170 mmHg. Patients had been required to discontinue any anti-hypertensive medications and were randomized 1:1 to RDN or sham control. In this post-hoc analysis, cumulative incidence curves with Kaplan-Meier estimates of rate of patients meeting escape criteria were generated for RDN and sham control patients. There were 16 RDN (9.6%) and 28 sham control patients (17.0%) who met escape criteria between baseline and 3 months. There was a significantly higher rate of sham control patients meeting escape criteria compared to RDN for all escape patients (p = 0.032), as well as for patients with a hypertensive urgency with office SBP ≥ 180 mmHg (p = 0.046). Rate of escape was similar between RDN and sham control for patients without a measured BP exceeding 180 mmHg (p = 0.32). In the SPYRAL HTN-OFF MED Pivotal trial, RDN patients were less likely to experience hypertensive urgencies that required immediate use of anti-hypertensive medications compared to sham control.

© 2022. The Author(s).

Clin Res Cardiol: 19 Jul 2022; epub ahead of print
Weber MA, Schmieder RE, Kandzari DE, Townsend RR, ... Fahy M, Böhm M
Clin Res Cardiol: 19 Jul 2022; epub ahead of print | PMID: 35852582
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Impact:
Abstract

Long-term follow-up of patients undergoing renal sympathetic denervation.

Zeijen VJM, Feyz L, Nannan Panday R, Veen K, ... Van Mieghem NM, Daemen J
Objectives
Renal denervation (RDN) proved to significantly lower blood pressure (BP) at 2-6 months in patients on and off antihypertensive drugs. Given a lack of longer-term follow-up data, our aim was to assess the safety and efficacy of RDN up to five years taking into account antihypertensive drug regimen changes over time.
Methods
In the present single-center study, patients underwent RDN for (therapy resistant) hypertension. Patients underwent protocolized yearly follow-up out to five years. Data were collected on 24-h ambulatory BP and office BP monitoring, renal function, antihypertensive drug regimen, and safety events, including non-invasive renal artery imaging at 6/12 months. Efficacy analyses were performed using linear mixed-effects models.
Results
Seventy-two patients with mean age 63.3 ± 9.5 (SD) years (51% female) were included. Median follow-up time was 3.5 years and Clark\'s Completeness Index was 72%. Baseline ambulatory daytime BP was 146.1/83.7 ± 17.4/12.2 mmHg under a mean number of 4.9 ± 2.7 defined daily doses (DDD). At five years, ambulatory daytime systolic BP as calculated from the mixed model was 120.8 (95% CI 114.2-127.5) mmHg and diastolic BP was 73.3 (95% CI 69.4-77.3) mmHg, implying a reduction of -20.9/-8.3 mmHg as compared to baseline estimates (p < 0.0001). The number of DDDs remained stable over time (p = 0.87). No procedure-related major adverse events resulting in long-term consequences were observed.
Conclusions
The BP-lowering effect of RDN was safely maintained at least five years post-procedure as reflected by a significant decrease in ambulatory daytime BP in the absence of escalating antihypertensive drug therapy over time.

© 2022. The Author(s).

Clin Res Cardiol: 18 Jul 2022; epub ahead of print
Zeijen VJM, Feyz L, Nannan Panday R, Veen K, ... Van Mieghem NM, Daemen J
Clin Res Cardiol: 18 Jul 2022; epub ahead of print | PMID: 35851428
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Abstract

Clinical and echocardiographic risk factors for device-related thrombus after left atrial appendage closure: an analysis from the multicenter EUROC-DRT registry.

Vij V, Piayda K, Nelles D, Gloekler S, ... Nickenig G, Sedaghat A
Background
Data on Device-related Thrombus (DRT) after left atrial appendage closure (LAAC) remain scarce. This study aimed to investigate risk factors for DRT from centers reporting to the EUROC-DRT registry.
Methods
We included 537 patients (112 with DRT and 425 without DRT) who had undergone LAAC between 12/2008 and 04/2019. Baseline and implantation characteristics, anti-thrombotic treatment and clinical outcomes were compared between both groups in uni- and multivariate analyses. Additional propensity-score matching (PSM) was conducted to focus on the role of implantation characteristics.
Results
Patients with DRT showed higher rates of previous stroke/transient ischemic attack (TIA) (49.1% vs. 34.7%, p < 0.01), spontaneous echocardiographic contrast (SEC) (44.9% vs. 27.7%, p < 0.01) and lower left atrial appendage (LAA) peak emptying velocity (35.4 ± 18.5 vs. 42.4 ± 18.0 cm/s, p = 0.02). Occluders implanted in DRT patients were larger (25.5 ± 3.8 vs. 24.6 ± 3.5 mm, p = 0.03) and implanted deeper in the LAA (mean depth: 7.6 ± 4.7 vs. 5.7 ± 4.7 mm, p < 0.01). Coverage of the appendage ostium was achieved less often in DRT patients (69.5% vs. 81.5%, p < 0.01), while DRT patients were less frequently on oral anticoagulation (7.1% vs. 16.7%, p < 0.01). Multivariate analysis identified age, prior stroke/TIA and SEC as independent risk factors for DRT. After PSM, implantation depth was found to be predictive. Rates of stroke/TIA were higher in DRT patients (13.5% vs. 3.8%, Hazard Ratio: 4.21 [95%-confidence interval: 1.88-9.49], p < 0.01).
Conclusions
DRT after LAAC is associated with adverse outcome and appears to be of multifactorial origin, depending on patient characteristics, anticoagulation regimen and device position.

© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.

Clin Res Cardiol: 18 Jul 2022; epub ahead of print
Vij V, Piayda K, Nelles D, Gloekler S, ... Nickenig G, Sedaghat A
Clin Res Cardiol: 18 Jul 2022; epub ahead of print | PMID: 35849156
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Abstract

The impact of bicuspid aortic valve morphology on von Willebrand factor function in patients with severe aortic stenosis and its change after TAVI.

Roth N, Heidel C, Xu C, Hubauer U, ... Jungbauer C, Debl K
Background
Aortic stenosis (AS) can cause acquired von Willebrand syndrome (AVWS) and valve replacement has been shown to lead to von Willebrand factor (vWF) recovery. The aim of the current study was to investigate the prevalence of AVWS in different severe AS phenotypes and its course after transcatheter aortic valve implantation (TAVI).
Methods
143 patients with severe AS undergoing TAVI were included in the study. vWF function was assessed at baseline, 6 and 24 h after TAVI. AVWS was defined as a reduced vWF:Ac/Ag ratio ≤ 0.7. Phenotypes were classified by tricuspid (TAV) and bicuspid (BAV) valve morphology, mean transvalvular gradient (Pmean), stroke volume index (SVI), ejection fraction (EF) and indexed effective orifice area (iEOA).
Results
AVWS was present in 36 (25.2%) patients before TAVI. vWF:Ac/Ag ratio was significantly lower in high gradient compared to low-gradient severe AS [0.78 (IQR 0.67-0.86) vs. 0.83 (IQR 0.74-0.93), p < 0.05] and in patients with BAV compared to TAV [0.70 (IQR 0.63-0.78) vs. 0.81 (IQR 0.71-0.89), p < 0.05]. Normalization of vWF:Ac/Ag ratio was achieved in 61% patients 24 h after TAVI. As in the overall study cohort, vWF:Ac/Ag ratio increased significantly in all severe AS subgroups 6 h after TAVI (each p < 0.05). Regarding binary logistic regression analysis, BAV was the only significant predictor for AVWS.
Conclusions
BAV morphology is a strong predictor for AVWS in severe AS. TAVI restores vWF function in most patients with severe AS independently of AS phenotype and valve morphology.

© 2022. The Author(s).

Clin Res Cardiol: 15 Jul 2022; epub ahead of print
Roth N, Heidel C, Xu C, Hubauer U, ... Jungbauer C, Debl K
Clin Res Cardiol: 15 Jul 2022; epub ahead of print | PMID: 35838799
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Abstract

Association of changes in cardiovascular health levels with incident cardiovascular events and mortality in patients with atrial fibrillation.

Cho S, Yang PS, Kim D, You SC, ... Lee MH, Joung B
Background
Risk factor management is crucial in the management of atrial fibrillation (AF). We investigated the association of changes in cardiovascular health (CVH) levels after AF diagnosis with incident cardiovascular events and mortality.
Methods
From the Korea National Health Insurance Service database, 76,628 patients newly diagnosed with AF (2005-2015) with information on health examinations before and after AF diagnosis were assessed. According to the change in the 12-point CVH score before and after AF diagnosis, patients were stratified into four groups: consistently low (score 0-7 to 0-7), high-to-low (8-12 to 0-7), low-to-high (0-7 to 8-12), and consistently high (8-12 to 8-12) CVH levels. Risks of cardiovascular events and death were analyzed using weighted Cox regression models with inverse probability of treatment weighting (IPTW) for balance across study groups.
Results
The mean age of study participants was 58.3 years, 50,285 were men (63.1%), and the mean follow-up was 5.5 years. After IPTW, low-to-high (hazard ratio [95% confidence interval], 0.83 [0.76-0.92]) and consistently high (0.80 [0.74-0.87]) CVH levels were associated with a lower risk of ischemic stroke than consistently low CVH. Low-to-high (0.66 [0.52-0.84]) and consistently high (0.52 [0.42-0.64]) CVH levels were associated with a lower risk of acute myocardial infarction. Maintaining high CVH was associated with reduced risks of heart failure hospitalization (0.85 [0.75-0.95]) and all-cause death (0.82 [0.77-0.88]), respectively, compared with consistently low CVH.
Conclusions
Improving CVH levels and maintaining high CVH levels after AF diagnosis is associated with lower risks of subsequent cardiovascular events and mortality.

© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.

Clin Res Cardiol: 13 Jul 2022; epub ahead of print
Cho S, Yang PS, Kim D, You SC, ... Lee MH, Joung B
Clin Res Cardiol: 13 Jul 2022; epub ahead of print | PMID: 35829750
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Abstract

Association between stress hyperglycemia on admission and unfavorable neurological outcome in OHCA patients receiving ECPR.

Taira T, Inoue A, Nishimura T, Takahashi R, ... Kuroda Y, Nakayama S
Background
Stress hyperglycemia is a normal response to stress and has been associated with outcomes in out-of-hospital cardiac arrest (OHCA) patients. However, this association remained unknown in OHCA patients receiving extracorporeal cardiopulmonary resuscitation (ECPR). This study aimed to examine the association between degree of stress hyperglycemia on admission and neurological outcomes at discharge in OHCA patients receiving ECPR.
Patients and methods
This was a retrospective cohort study of adult OHCA patients receiving ECPR between 2011 and 2021. Patients were classified into three groups: absence of stress hyperglycemia (blood glucose level on admission < 200 mg/dL), moderate stress hyperglycemia (200-299 mg/dL), and severe stress hyperglycemia (≥ 300 mg/dL). The primary outcome was unfavorable neurological outcome (Cerebral Performance Category: 3-5) at discharge.
Results
This study included 160 patients; unfavorable neurological outcomes totaled 79.4% (n = 127). There were 23, 52, and 85 patients in the absence, moderate, and severe stress hyperglycemia groups, respectively. Of each group, unfavorable neurological outcomes constituted 91.3%, 71.2%, and 81.2%, respectively. Multivariable analysis showed that, compared with moderate stress hyperglycemia, absence of stress hyperglycemia on admission was significantly associated with unfavorable neurological outcome at discharge (odds ratio [OR], 4.70; 95% confidence interval [CI], 1.07-33.35; p = 0.039).
Conclusion
Compared with moderate stress hyperglycemia on admission, absence of stress hyperglycemia showed significant association with unfavorable neurological outcome at discharge in OHCA patients receiving ECPR.

© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.

Clin Res Cardiol: 08 Jul 2022; epub ahead of print
Taira T, Inoue A, Nishimura T, Takahashi R, ... Kuroda Y, Nakayama S
Clin Res Cardiol: 08 Jul 2022; epub ahead of print | PMID: 35802161
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Abstract

Ticagrelor or prasugrel in patients with acute coronary syndrome with off-hour versus on-hour presentation: a subgroup analysis of the ISAR-REACT 5 trial.

Behnes M, Lahu S, Ndrepepa G, Menichelli M, ... Kastrati A, Akin I
Objectives
To assess the efficacy and safety of ticagrelor versus prasugrel in patients with acute coronary syndrome (ACS) presenting during off- and on-hours.
Background
The efficacy and safety of ticagrelor versus prasugrel in patients with ACS according to time of hospital presentation remain unknown.
Methods
This post hoc analysis of the ISAR-REACT 5 trial included 1565 patients with ACS presenting off-hours and 2453 patients presenting on-hours, randomized to ticagrelor or prasugrel. The primary endpoint was a composite of death, myocardial infarction, or stroke; the safety endpoint was Bleeding Academic Research Consortium (BARC) type 3-5 bleeding, both at 12 months.
Results
The primary endpoint occurred in 80 patients (10.4%) in the ticagrelor group and 57 patients (7.3%) in the prasugrel group in patients presenting off-hours (hazard ratio [HR] = 1.45; 95% confidence interval [CI] 1.03-2.03; P = 0.033), and 104 patients (8.5%) in the ticagrelor group and 80 patients (6.7%) in the prasugrel group in patients presenting on-hours (HR = 1.29 [0.97-1.73]; P = 0.085), without significant treatment arm-by-presentation time interaction (Pint = 0.62). BARC type 3 to 5 bleeding occurred in 35 patients (5.1%) in the ticagrelor group and 37 patients (5.3%) in the prasugrel group (P = 0.84) in patients presenting off-hours, and 60 patients (5.9%) in the ticagrelor group and 43 patients (4.6%) in the prasugrel group in patients presenting on-hours (P = 0.17).
Conclusions
In patients with ACS planned to undergo an invasive treatment strategy, time of presentation (off-hours vs. on-hours) does not interact significantly with the relative efficacy and safety of ticagrelor vs. prasugrel.
Clinical trial registration
NCT01944800.

© 2022. The Author(s).

Clin Res Cardiol: 05 Jul 2022; epub ahead of print
Behnes M, Lahu S, Ndrepepa G, Menichelli M, ... Kastrati A, Akin I
Clin Res Cardiol: 05 Jul 2022; epub ahead of print | PMID: 35789430
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Abstract

Guideline-directed medical therapy is similarly effective in heart failure with mildly reduced ejection fraction.

Straw S, Cole CA, McGinlay M, Drozd M, ... Witte KK, Gierula J
Aims
Current guidelines recommend that disease-modifying pharmacological therapies may be considered for patients who have heart failure with mildly reduced ejection fraction (HFmrEF). We aimed to describe the characteristics, outcomes, provision of pharmacological therapies and dose-related associations with mortality risk in HFmrEF.
Methods and results
We explored data from two prospective observational studies, which permitted the examination of the effects of pharmacological therapies across a broad spectrum of left ventricular ejection fraction (LVEF). The combined dataset consisted of 2388 unique patients, with a mean age of 73.7 ± 13.2 years of whom 1525 (63.9%) were male. LVEF ranged from 5 to 71% (mean 37.2 ± 12.8%) and 1504 (63.0%) were categorised as having reduced ejection fraction (HFrEF), 421 (17.6%) as HFmrEF and 463 (19.4%) as preserved ejection fraction (HFpEF). Patients with HFmrEF more closely resembled HFrEF than HFpEF. Adjusted all-cause mortality risk was lower in HFmrEF (hazard ratio [HR] 0.86 (95% confidence interval [CI] 0.74-0.99); p = 0.040) and in HFpEF (HR 0.61 (95% CI 0.52-0.71); p < 0.001) compared to HFrEF. Adjusted all-cause mortality risk was lower in patients with HFrEF and HFmrEF who received the highest doses of beta-blockers or renin-angiotensin inhibitors. These associations were not evident in HFpEF. Once adjusted for relevant confounders, each mg equivalent of bisoprolol (HR 0.95 [95% CI 0.91-1.00]; p = 0.047) and ramipril (HR 0.95 [95%CI 0.90-1.00]; p = 0.044) was associated with incremental reductions in mortality risk in patients with HFmrEF.
Conclusions
Pharmacological therapies were associated with lower mortality risk in HFmrEF, supporting guideline recommendations which extend the indications of these agents to all patients with LVEF < 50%. HFmrEF more closely resembles HFrEF in terms of clinical characteristics and outcomes. Pharmacological therapies are associated with lower mortality risk in HFmrEF and HFrEF, but not in HFpEF.

© 2022. The Author(s).

Clin Res Cardiol: 04 Jul 2022; epub ahead of print
Straw S, Cole CA, McGinlay M, Drozd M, ... Witte KK, Gierula J
Clin Res Cardiol: 04 Jul 2022; epub ahead of print | PMID: 35781605
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This program is still in alpha version.