Journal: Clin Res Cardiol

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Abstract

Validation of the modified Microlife blood pressure monitor in patients with paroxysmal atrial fibrillation.

Huppertz N, Lip GYH, Lane DA
Aims
Undiagnosed atrial fibrillation (AF) accounts for 6% of all strokes, therefore early detection and treatment of the arrhythmia are paramount. Previous research has illustrated that the Microlife WatchBPO3 AFIB, an automated blood pressure (BP) monitor with an inbuilt AF algorithm, accurately detects permanent AF. Currently, limited data exist on whether the modified BP monitor is able to detect paroxysmal AF (PAF). Therefore, this study aims to assess the accuracy of the Microlife WatchBPO3 AFIB monitor to detect PAF against a pacemaker reference standard over a 24-h period.
Methods and results
Forty-eight patients with a pacemaker implanted for sick sinus syndrome and previously documented fast AF participated. Sensitivity of the atrial pacemaker lead was set to allow detection of signals of ≥ 0.5 mV. Patients engaged in their normal daily routine whilst wearing the modified BP monitor. The modified BP monitor demonstrated an overall sensitivity of 76.0% and specificity of 80.8% for detecting PAF. This sensitivity and specificity increased to 100% and 83.1%, respectively, for patients that achieved more than 80% successful BP readings. Compared to day-time readings, night-time readings also demonstrated a lower proportion of movement artefact (14.4% vs. 3.4%), and therefore, a higher sensitivity and specificity of 100% and 84.9%, respectively, for detecting PAF.
Conclusion
The Microlife WatchBPO3 AFIB device has an acceptable diagnostic accuracy to detect PAF; however, movement artefact affects the accuracy of the readings. This modified BP monitor may potentially be useful as a screening tool for AF in patients at high risk of developing stroke.



Clin Res Cardiol: 06 Nov 2019; epub ahead of print
Huppertz N, Lip GYH, Lane DA
Clin Res Cardiol: 06 Nov 2019; epub ahead of print | PMID: 31701215
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Abstract

Percutaneous left atrial appendage closure using the TrueFusion™ fusion-imaging technology.

Nelles D, Schrickel JW, Nickenig G, Sedaghat A
Objective
To describe percutaneous left atrial appendage closure (LAAc) in a patient with recurrent gastric ulcer bleeding with the help of the TrueFusion™ fusion-imaging system.
Method and results
In a patient with paroxysmal atrial fibrillation, the need for an effective oral anticoagulation and recurrent gastrointestinal bleeding, left atrial appendage closure (LAAc) was performed under guidance of the TrueFusion™ fusion-imaging technology (Siemens Healthineers, Erlangen, Germany) to enhance procedural precision, save radiation time and contrast dye. Left atrial appendage closure was performed with the use of a 20 mm Amplatzer Amulet™ (Abbott Laboratories, Chicago, IL, USA) using the TrueFusion™ system under mild sedation with minimal use of contrast. Intraprocedural transesophageal echocardiography revealed complete LAA occlusion without residual flow. The patient was uneventfully discharged on the second postoperative day.
Conclusion
LAAc using an integrated approach combining ultrasound and live fluoroscopy, as provided by the TrueFusion™, is safe and feasible. Target-oriented device navigation and synchronized image orientation as provided by fusion imaging may potentially be beneficial regarding radiation time, contrast dye and periprocedural risk of suboptimal device positioning.



Clin Res Cardiol: 03 Nov 2019; epub ahead of print
Nelles D, Schrickel JW, Nickenig G, Sedaghat A
Clin Res Cardiol: 03 Nov 2019; epub ahead of print | PMID: 31686210
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Abstract

Contemporary scientometric analyses using a novel web application: the science performance evaluation (SciPE) approach.

Scholz SS, Dillmann M, Flohr A, Backes C, ... Keller A, Mahfoud F
Aims
We aimed at developing a structured study protocol utilizing the bibliographic web-application science performance evaluation (SciPE) to perform comprehensive scientometric analyses.
Methods and results
Metadata related to publications derived from online databases were processed and visualized by transferring the information to an undirected multipartite graph and distinct partitioned sets of nodes. Also, institution-specific data were normalized and merged allowing precise geocoordinate positioning, to enable heatmapping and valid identification. As a result, verified, processed data regarding articles, institutions, journals, authors gender, nations and subject categories can be obtained. We recommend including the total number of publications, citations, the population, research institutions, gross domestic product, and the country-specific modified Hirsch Index and to form corresponding ratios (e.g., population/publication). Also, our approach includes implementation of bioinformatical methods such as heatmapping based on exact geocoordinates, simple chord diagrams, and the central implementation of specific ratios with plain visualization techniques.
Conclusion
This protocol allows precise conduction of contemporaneous scientometric analyses based on bioinformatic and meta-analytical techniques, allowing to evaluate and contextualize scientific efforts. Data presentation with the depicted visualization techniques is mandatory for transparent and consistent analyses of research output across different nations and topics. Research performance can then be discussed in a synopsis of all findings.



Clin Res Cardiol: 03 Nov 2019; epub ahead of print
Scholz SS, Dillmann M, Flohr A, Backes C, ... Keller A, Mahfoud F
Clin Res Cardiol: 03 Nov 2019; epub ahead of print | PMID: 31686209
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Abstract

Fractional flow reserve in patients with coronary artery disease undergoing TAVI: a prospective analysis.

Stundl A, Shamekhi J, Bernhardt S, Starke M, ... Werner N, Sinning JM
Objectives
To determine the true prevalence of CAD in AS patients, to detect changes of the hemodynamic significance of coronary lesions following TAVI, to explore to what extent FFR-positive CAD might influence outcome and finally to develop a management algorithm for this patient subset.
Methods
From May 2016 to March 2018, diagnostic coronary angiography was performed in 246 patients before TAVI. In the presence of coronary lesions with a diameter stenosis ≥ 50%, FFR was measured. In patients with positive FFR ≤ 0.80, a control angiography was performed 6-8 weeks after TAVI.
Results
The study cohort was 81.0 ± 6.1 years old, 48.4% of the patients were male. 53.3% had concomitant CAD. 35.9% of these patients underwent PCI before TAVI due to functionally significant left main CAD and/or severe stenosis ≥ 90%. 31 patients underwent FFR measurements in cumulative 38 coronary lesions. Prior to TAVI, a negative FFR could be detected in 18 lesions, whereas a positive FFR was found in entirely 20 lesions. A control angiography and FFR measurement was performed in cumulative 13 lesions. Comparing the FFR values, there was no significant difference (0.77 ± 0.04 vs. 0.76 ± 0.08; p = 0.11).
Conclusion
Concomitant CAD was diagnosed in 53.3% of TAVI patients. FFR did not significantly change after TAVI, confirming the validity of FFR to evaluate coronary lesions in this specific clinical setting. Given the low rates of cardiac adverse events, it might therefore be considered to treat coronary stenoses not involving left main and those with a diameter stenosis < 90% after TAVI.



Clin Res Cardiol: 01 Nov 2019; epub ahead of print
Stundl A, Shamekhi J, Bernhardt S, Starke M, ... Werner N, Sinning JM
Clin Res Cardiol: 01 Nov 2019; epub ahead of print | PMID: 31679046
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Abstract

Outcome differences and device performance of the subcutaneous ICD in patients with and without structural heart disease.

Willy K, Reinke F, Bögeholz N, Ellermann C, ... Eckardt L, Frommeyer G
Background
The performance of the subcutaneous ICD (S-ICD™) has been described in different kinds of heart disease and has been proven to be an important advance in prevention of sudden cardiac death (SCD). While positive experiences with the S-ICD™ initially came from collectives of patients without structural heart diseases, positive results have also been collected from cohorts with structural heart disease.
Materials and methods
All S-ICD™ patients with either ischemic cardiomyopathy (ICM), dilated cardiomyopathy (DCM) or hypertrophic cardiomyopathy (HCM) as the main indication for ICD implantation (n = 144 patients) or electrical heart disease/idiopathic ventricular fibrillation (n = 83 patients) in our large-scaled single-center S-ICD™ registry were included in this study. Baseline characteristics, appropriate and inappropriate shocks, and complications were documented in a mean follow-up of 18 ± 15 months.
Results
Baseline characteristics were significantly different between the two groups in most categories. In contrast, there was no difference concerning neither appropriate nor inappropriate shock delivery between the two groups. Also other outcome parameters such as need for surgical revisions and all-cause mortality did not differ. There was a significant difference between the first- and second-generation S-ICDs™ in inadequate shocks mainly driven by patients with HCM.
Conclusion
In our study, S-ICD™ performance was similar in patients with and without structural heart disease. Decision pro- or contra-S-ICD™ should be made rather on the basis of expected shock rate and probability of the need for future anti-tachycardia or anti-bradycardia pacing than in dependence of the underlying heart disease.



Clin Res Cardiol: 30 Oct 2019; epub ahead of print
Willy K, Reinke F, Bögeholz N, Ellermann C, ... Eckardt L, Frommeyer G
Clin Res Cardiol: 30 Oct 2019; epub ahead of print | PMID: 31667624
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Abstract

Significance of psychosocial factors in cardiology: update 2018 : Position paper of the German Cardiac Society.

Albus C, Waller C, Fritzsche K, Gunold H, ... Weber CS, Herrmann-Lingen C
Background
Psychosocial factors in cardiovascular diseases are increasingly acknowledged by patients, health care providers and payer organizations. Due to the rapidly increasing body of evidence, the German Cardiac Society has commissioned an update of its 2013 position paper on this topic. The German version was published in 2018 and the current manuscript is an extended translation of the original version.
Methods
This position paper provides a synopsis of the state of knowledge regarding psychosocial factors in the most relevant cardiovascular diseases and gives recommendations with respect to their consideration in clinical practice.
Results
Psychosocial factors such as low socioeconomic status, acute and chronic stress, depression, anxiety and low social support are associated with an unfavorable prognosis. Psychosocial problems and mental comorbidities should be assessed routinely to initiate targeted diagnostics and treatment. For all patients, treatment should consider age and gender differences as well as individual patient preferences. Multimodal treatment concepts should comprise education, physical exercise, motivational counseling and relaxation training or stress management. In cases of mental comorbidities, brief psychosocial interventions by primary care providers or cardiologists, regular psychotherapy and/or medications should be offered. While these interventions have positive effects on psychological symptoms, robust evidence for possible effects on cardiac outcomes is still lacking.
Conclusions
For coronary heart disease, chronic heart failure, arterial hypertension, and some arrhythmias, there is robust evidence supporting the relevance of psychosocial factors, pointing to a need for considering them in cardiological care. However, there are still shortcomings in implementing psychosocial treatment, and prognostic effects of psychotherapy and psychotropic drugs remain uncertain. There is a need for enhanced provider education and more treatment trials.



Clin Res Cardiol: 30 Oct 2019; 108:1175-1196
Albus C, Waller C, Fritzsche K, Gunold H, ... Weber CS, Herrmann-Lingen C
Clin Res Cardiol: 30 Oct 2019; 108:1175-1196 | PMID: 31076853
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Abstract

One year VARC-2-defined clinical outcomes after transcatheter aortic valve implantation with the SAPIEN 3.

Pellegrini C, Rheude T, Trenkwalder T, Mayr NP, ... Husser O, Hengstenberg C
Aims
To evaluate 1-year outcome after transcatheter aortic valve implantation (TAVI) using the SAPIEN 3 (S3) prosthesis with emphasis on the composite endpoints \"clinical efficacy after 30 days\" and \"time-related valve safety\" proposed by the updated Valve Academic Research Consortium (VARC-2).
Methods and results
Four hundred and two consecutive patients undergoing transfemoral TAVI with the S3 were enrolled. Mean age was 81 ± 6 years, 43% were female and median logistic EuroSCORE I was 12% [8-19]. Device success was achieved in 93% (374/402) with moderate or severe paravalvular leakage (PVL) in 2%. At 1 year all-cause mortality was 8.9% [95% CI 6.4-12.2] and new permanent pacemaker implantation rate was 16% [95% CI 12.7-20.4]. The composite endpoint time-related valve safety occurred in 29% with structural valve deterioration, defined as elevated gradients or more than moderate PVL, occurring in 13%. The clinical efficacy endpoint after 30 days was observed in 37% of patients with the main contributor symptom worsening with New York Heart Association functional class III + in 17% of cases.
Conclusions
For the first time, VARC-2-defined composite endpoints at 1 year are reported and reveal a considerable proportion of patients experiencing the endpoint of time-related valve safety (29%) and clinical efficacy after 30 days (37%).



Clin Res Cardiol: 30 Oct 2019; 108:1258-1265
Pellegrini C, Rheude T, Trenkwalder T, Mayr NP, ... Husser O, Hengstenberg C
Clin Res Cardiol: 30 Oct 2019; 108:1258-1265 | PMID: 31049679
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Abstract

Clinical and genetic insights into non-compaction: a meta-analysis and systematic review on 7598 individuals.

Kayvanpour E, Sedaghat-Hamedani F, Gi WT, Tugrul OF, ... Katus HA, Meder B
Background
Left ventricular non-compaction has been increasingly diagnosed in recent years. However, it is still debated whether non-compaction is a pathological condition or a physiological trait. In this meta-analysis and systematic review, we compare studies, which investigated these two different perspectives. Furthermore, we provide a comprehensive overview on the clinical outcome as well as genetic background of left ventricular non-compaction cardiomyopathy in adult patients.
Methods and results
We retrieved PubMed/Medline literatures in English language from 2000 to 19/09/2018 on clinical outcome and genotype of patients with non-compaction. We summarized and extensively reviewed all studies that passed selection criteria and performed a meta-analysis on key phenotypic parameters. Altogether, 35 studies with 2271 non-compaction patients were included in our meta-analysis. The mean age at diagnosis was the mid of their fifth decade. Two-thirds of patients were male. Congenital heart diseases including atrial or ventricular septum defect or Ebstein anomaly were reported in 7% of patients. Twenty-four percent presented with family history of cardiomyopathy. The mean frequency of neuromuscular diseases was 5%. Heart rhythm abnormalities were reported frequently: conduction disease in 26%, supraventricular tachycardia in 17%, and sustained or non-sustained ventricular tachycardia in 18% of patients. Three important outcome measures were reported including systemic thromboembolic events with a mean frequency of 9%, heart transplantation with 4%, and adequate ICD therapy with 15%. Nine studies investigated the genetics of non-compaction cardiomyopathy. The most frequently mutated gene was TTN with a pooled frequency of 11%. The average frequency of MYH7 mutations was 9%, for MYBPC3 mutations 5%, and for CASQ2 and LDB3 3% each. TPM1, MIB1, ACTC1, and LMNA mutations had an average frequency of 2% each. Mutations in PLN, HCN4, TAZ, DTNA, TNNT2, and RBM20 were reported with a frequency of 1% each. We also summarized the results of eight studies investigating the non-compaction in altogether 5327 athletes, pregnant women, patients with sickle cell disease, as well as individuals from population-based cohorts, in which the presence of left ventricular hypertrabeculation ranged from 1.3 to 37%.
Conclusion
The summarized data indicate that non-compaction may lead to unfavorable outcome in different cardiomyopathy entities. The presence of key features in a multimodal diagnostic approach could distinguish between benign morphological trait and manifest cardiomyopathy.



Clin Res Cardiol: 30 Oct 2019; 108:1297-1308
Kayvanpour E, Sedaghat-Hamedani F, Gi WT, Tugrul OF, ... Katus HA, Meder B
Clin Res Cardiol: 30 Oct 2019; 108:1297-1308 | PMID: 30980206
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Impact:
Abstract

Aortic annulus measurement with computed tomography angiography reduces aortic regurgitation after transfemoral aortic valve replacement compared to 3-D echocardiography: a single-centre experience.

Wystub N, Bäz L, Möbius-Winkler S, Pörner TC, ... Schulze PC, Franz M
Background
Accurate assessment of the aortic annulus is crucial for successful transcatheter aortic valve replacement (TAVR), in particular to prevent paravalvular regurgitation (PVR). We compared aortic annular sizing using multidetector computed tomography (MDCT) and three-dimensional transoesophageal echocardiography (3-D TEE) to determine the predictive value of MDCT.
Methods and results
All patients admitted for transfemoral TAVR [n = 227; 48.9% balloon expandable (Edwards Sapien 3); 51.1% self-expandable (Core Valve, Evolut R)] at our institution from January 2015 until December 2016 were analysed retrospectively. Aortic annular parameters were obtained either by MDCT or 3-D TEE. Additionally, we included a cohort of patients (n = 27) assessed by both MDCT and 3D TEE between October 2017 and April 2018 to enable intra-individual comparison of the two methods. Indications for TAVR were severe degenerative aortic stenosis (AS; 94.7%) or re-stenosis after surgical AVR (5.3%). 74.4% were classified as high-gradient AS. The mean age was 80 (37-94) years and 75.8% presented with NYHA III/IV. STS risk of mortality was intermediate (3.5 ± 2.3). MDCT and 3-D TEE were performed in 116 and 111 patients for aortic annulus sizing, respectively. Significantly larger implants were chosen in the CT group irrespective of prosthesis type or post-dilatation. Follow-up (median at 79 days) revealed significantly less PVR in the MDCT compared to 3-D TEE group (absence of PVR in 59.3% and 40.7%, p = 0.016), without differences in mortality. Patients without PVR or mild PVR had a better clinical performance according to NYHA class (p = 0.016).
Conclusion
MDCT is superior to 3-D TEE in terms of sizing accuracy and clinical outcomes. Reduction of PVR after TAVR with MDCT is likely due to valve annulus undersizing by TEE.



Clin Res Cardiol: 30 Oct 2019; 108:1266-1275
Wystub N, Bäz L, Möbius-Winkler S, Pörner TC, ... Schulze PC, Franz M
Clin Res Cardiol: 30 Oct 2019; 108:1266-1275 | PMID: 30972479
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Abstract

Does rhythm matter in acute heart failure? An insight from the British Society for Heart Failure National Audit.

Anderson SG, Shoaib A, Myint PK, Cleland JG, ... Garratt CJ, Mamas MA
Background
Atrial fibrillation (AF) is the most common sustained arrhythmia in patients with acute heart failure (AHF). The presence of AF is associated with adverse prognosis in patients with chronic heart failure (CHF) but little is known about its impact in AHF.
Methods
Data were collected between April 2007 and March 2013 across 185 (> 95%) hospitals in England and Wales from patients with a primary death or a discharge diagnosis of AHF. We investigated the association between the presence of AF and all-cause mortality during the index hospital admission, at 30 days and 1 year post-discharge.
Results
Of 96,593 patients admitted with AHF, 44,642 (46%) were in sinus rhythm (SR) and 51,951 (54%) in AF. Patients with AF were older (mean age 79.8 (79.7-80) versus 74.7 (74.5-74.7) years; p < 0.001), than those in SR. In a multivariable analysis, AF was independently associated with mortality at all time points, in hospital (HR 1.15, 95% CI 1.09-1.21, p < 0.0001), 30 days (HR 1.13, 95% CI 1.08-1.19, p < 0.0001), and 1 year (HR 1.09, 95% CI 1.05-1.12, p < 0.0001). In subgroup analyses, AF was independently associated with worse 30-day outcome irrespective of sex, ventricular phenotype and in all age groups except in those aged between 55 and 74 years.
Conclusion
AF is independently associated with adverse prognosis in AHF during admission and up to 1 year post-discharge. As the clinical burden of concomitant AF and AHF increases, further refinement in the detection, treatment and prevention of AF-related complications may have a role in improving patient outcomes.



Clin Res Cardiol: 30 Oct 2019; 108:1276-1286
Anderson SG, Shoaib A, Myint PK, Cleland JG, ... Garratt CJ, Mamas MA
Clin Res Cardiol: 30 Oct 2019; 108:1276-1286 | PMID: 30963233
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Impact:
Abstract

Effect of baroreflex activation therapy on renal sodium excretion in patients with resistant hypertension.

Lipphardt M, Koziolek MJ, Lehnig LY, Schäfer AK, ... Lüders S, Wallbach M
Objective
Activation of the sympathetic nervous system increases sodium retention in resistant hypertension. Baroreflex activation therapy (BAT) is an interventional method to reduce sympathetic overactivity in patients with resistant hypertension. This study aimed to assess the effect of BAT on urinary sodium excretion.
Methods
From 2012 to 2015, consecutive patients with resistant hypertension and blood pressure (BP) above target despite polypharmacy strategies were consecutively included in this observational study. BAT was provided with the individual adaption of programmed parameters over the first months. 24-h urinary sodium excretion (UNa) was estimated at baseline and after 6 months using the Kawasaki formula in patients undergoing BAT. Additionally, the fractional sodium excretion, plasma renin activity, and aldosterone levels were assessed.
Results
Forty-two patients completed the 6-month follow-up period. Office systolic and ambulatory 24-h systolic BP at baseline were 169 ± 27 mmHg and 148 ± 16 mmHg despite a median intake of 7(3-9) antihypertensive drugs. After 6 months of BAT, systolic office BP decreased to 150 ± 29 mmHg (p < 0.01), 24-h systolic BP to 142 ± 22 mmHg (p = 0.04) and 24-h UNa increased by 37% compared to baseline (128 ± 66 vs. 155 ± 83 mmol/day, p < 0.01). These findings were accompanied by a significant increase in fractional sodium excretion (0.74% [0.43-1.47] to 0.92% [0.61-1.92]; p = 0.02). However, in contrast to the significant BP reduction, eGFR, plasma sodium, renin activity and aldosterone levels did not change during BAT. The increase in sodium excretion was correlated with the change in eGFR (r = 0.371; p = 0.015).
Conclusion
The present study revealed a significant increase of estimated 24-h UNa which may contribute to the long-term BP-lowering effects of this interventional method.



Clin Res Cardiol: 30 Oct 2019; 108:1287-1296
Lipphardt M, Koziolek MJ, Lehnig LY, Schäfer AK, ... Lüders S, Wallbach M
Clin Res Cardiol: 30 Oct 2019; 108:1287-1296 | PMID: 30955077
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Impact:
Abstract

Mean BMI, visit-to-visit BMI variability and BMI changes during follow-up in patients with acute myocardial infarction with systolic dysfunction and/or heart failure: insights from the High-Risk Myocardial Infarction Initiative.

Stienen S, Ferreira JP, Girerd N, Duarte K, ... Rossignol P,
Background
In patients with acute myocardial infarction (MI), BMI < 18.5 kg/m and a decrease in BMI during follow-up have been associated with poor prognosis. For BMI ≥ 25 kg/m, an \"obesity paradox\" has been suggested. Recently, high visit-to-visit BMI variability has also been associated with poor prognosis in patients with coronary artery disease.
Aims
To simultaneously evaluate several BMI measurements and study their association with cardiovascular (CV) outcomes in a large cohort of patients with acute myocardial infarction (MI) and left ventricular (LV) systolic dysfunction, heart failure (HF) or both.
Methods
The high-risk MI dataset is pooled from four trials: CAPRICORN, EPHESUS, OPTIMAAL and VALIANT. Mean BMI, change from baseline, and variability were assessed during follow-up. The primary outcome was CV death. Cox-proportional hazard models were performed to study the association between the various BMI parameters and outcomes (median follow-up = 1.8 years).
Results
A total of 12,719 patients were included (72% male, mean age 65 ± 11 years). Mean, change and visit-to-visit variability in BMI had a non-linear association with CV death (P < 0.001). Mean BMI < 26 kg/m (vs. ≥ 26-35 kg/m) and BMI decrease during follow-up were independently associated with CV death (adjusted HR 1.32, 95% CI 1.16-1.51, P < 0.001 and adjusted HR 1.57, 95% CI 1.40-1.76, P < 0.001, respectively). Low and high BMI variability (< 2% and > 4%) were associated with increased event-rates, but lost statistical significance in sensitivity analysis including patients with ≥ 5 measurements or excluding patients with HF hospitalization, suggesting that BMI variability may be particularly associated with HF hospitalizations.
Conclusion
Mean BMI < 26 kg/m and a BMI decrease during follow-up were independently associated with CV death in patients with MI and LV systolic dysfunction, HF or both. These associations likely reflect poorer patient status and causality cannot be inferred.



Clin Res Cardiol: 30 Oct 2019; 108:1215-1225
Stienen S, Ferreira JP, Girerd N, Duarte K, ... Rossignol P,
Clin Res Cardiol: 30 Oct 2019; 108:1215-1225 | PMID: 30953180
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Abstract

Feasibility of entirely subcutaneous ICD™ systems in patients with coronary artery disease.

Willy K, Bettin M, Reinke F, Bögeholz N, ... Eckardt L, Frommeyer G
Background
The subcutaneous ICD (S-ICD™) is an important advance in device therapy for the prevention of sudden cardiac death (SCD). Although current guidelines recommend S-ICD™ use, long-term data are still limited, especially in subgroups. Among several cardiac diseases that prone to SCD, coronary artery disease (CAD) carries several peculiarities that may hamper S-ICD™ therapy in this cohort. CAD can lead to an ischemic cardiomyopathy (ICM) with a reduced left-ventricular ejection fraction (LVEF) and bundle branch blocks, which can be difficult for ICD sensing and discrimination of arrhythmia. CAD is mainly driven by risk factors such as diabetes mellitus, which put these patients at an elevated risk for infectious complications of cardiac devices. Furthermore, in ICM myocardial scars are frequent and are a potential substrate for ventricular tachycardia, which may be accessible for antitachycardia pacing. At the moment, it remains unclear if there is a value of S-ICD™ therapy in this subgroup. Therefore, this study analysed patients with CAD.
Materials and methods
All S-ICD™ patients with CAD as the main indication for ICD implantation (n = 45 patients) in our large-scaled single-center S-ICD™ registry (n = 249 patients) were included in this study. Baseline characteristics, appropriate and inappropriate shocks, and complications were documented in a mean follow-up of 22.5 ± 8.3 months.
Results
Primary prevention of SCD was the indication for implantation of an S-ICD™ in 28 patients (62%). Of all 45 patients with an overall mean age of 58.1 ± 11.4 years, 40 were male (88%). The mean LVEF was 37.7 ± 12.6%. Three episodes of ventricular arrhythmia (one monomorphic, one polymorphic, one ventricular fibrillation) were adequately terminated in three patients (7%). In only one patient, oversensing resulting in an inappropriate shock was observed, which could be managed by changing the sensing vector. 15 of the examined 45 patients previously had a transvenous ICD, which was explanted due to system-related infections. In only two patients, S-ICD™ was changed to transvenous ICD because of the need of antibradycardia stimulation. There were no S-ICD™ system-related infections.
Conclusion
The S-ICD™ seems to be a valuable option for the prevention of SCD in CAD patients. Patients with systemic infections of a transvenous ICD and, therefore, a need for an alternative might benefit from the absence of intracardiac leads as the S-ICD™ is safe and works flawlessly in these patients. Inadequate shock delivery was very rare, while every episode of ventricular arrhythmia was terminated by the first shock.



Clin Res Cardiol: 30 Oct 2019; 108:1234-1239
Willy K, Bettin M, Reinke F, Bögeholz N, ... Eckardt L, Frommeyer G
Clin Res Cardiol: 30 Oct 2019; 108:1234-1239 | PMID: 30903274
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Impact:
Abstract

Mechanical circulatory support with Impella versus intra-aortic balloon pump or medical treatment in cardiogenic shock-a critical appraisal of current data.

Wernly B, Seelmaier C, Leistner D, Stähli BE, ... Thiele H, Lauten A
Aims
Patients suffering from cardiogenic shock (CS) have a high mortality and morbidity. The Impella percutaneous left-ventricular assist device (LVAD) decreases LV preload, increases cardiac output, and improves coronary blood flow. We aimed to review and meta-analyze available data comparing Impella versus intra-aortic pump (IABP) counterpulsation or medical treatment in CS due to acute myocardial infarction or post-cardiac arrest.
Methods and results
Study-level data were analyzed. Heterogeneity was assessed using the I statistic. Risk rates were calculated and obtained using a random-effects model (DerSimonian and Laird). Four studies were found suitable for the final analysis, including 588 patients. Primary endpoint was short-term mortality (in-hospital or 30-day mortality). In a meta-analysis of four studies comparing Impella versus control, Impella was not associated with improved short-term mortality (in-hospital or 30-day mortality; RR 0.84; 95% CI 0.57-1.24; p = 0.38; I 55%). Stroke risk was not increased (RR 1.00; 95% CI 0.36-2.81; p = 1.00; I2 0%), but risk for major bleeding (RR 3.11 95% CI 1.50-6.44; p = 0.002; I 0%) and peripheral ischemia complications (RR 2.58; 95% CI 1.24-5.34; p = 0.01; I 0%) were increased in the Impella group.
Conclusion
In patients suffering from severe CS due to AMI, the use of Impella is not associated with improved short-time survival but with higher complications rates compared to IABP and medical treatment. Better patient selection avoiding Impella implantation in futile situations or in possible lower risk CS might be necessary to elucidate possible advantages of Impella in future studies.



Clin Res Cardiol: 30 Oct 2019; 108:1249-1257
Wernly B, Seelmaier C, Leistner D, Stähli BE, ... Thiele H, Lauten A
Clin Res Cardiol: 30 Oct 2019; 108:1249-1257 | PMID: 30900010
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Impact:
Abstract

Angiotensin-converting-enzyme inhibitors in hemodynamic congestion: a meta-analysis of early studies.

Jobs A, Abdin A, de Waha-Thiele S, Eitel I, ... de Wit C, Vonthein R
Aim
Major clinical trials have shown that angiotensin-converting enzyme (ACE) inhibitors reduce mortality and morbidity in congestive heart failure (HF). Prior to these seminal findings hemodynamic effects of ACE inhibitors were examined in small studies. We aimed to review these studies systematically and meta-analyze the effects of ACE inhibitors on hemodynamics in HF.
Methods and results
We identified studies investigating the acute hemodynamic effect of ACE inhibitors in naïve patients with congestive heart failure by searching PubMed and the Cochrane Central Register of Controlled Trials. We extracted the changes in hemodynamic measures and their standard errors from study reports or calculated these values from baseline and post-medication measurements. Data were pooled using random effects models. In total, 41 studies with 46 independent cohorts consisting of 676 patients were included. ACE inhibitor treatment reduced pulmonary capillary wedge pressure by 7.3 (95% confidence interval 6.4-8.2) mmHg and right atrial pressure by 3.7 (95% confidence interval 1.3-6.1) mmHg in patients with HF. Cardiac index increased by 0.4 (95% confidence interval 0.2-0.6) ml/min/m. Changes in hemodynamic measures were strongly connected to each other in weighted simple linear regression models.
Conclusion
Angiotensin-converting enzyme-inhibitors acutely reduced cardiac filling pressures and increased cardiac output in patients with congestive heart failure who were naïve for these drugs. These data indicate that ACE inhibitors exhibit a strong decongesting effect in congestive heart failure. In light of their impact on long-term prognosis, ACE inhibitors should also be considered as decongesting drugs in stable patients.



Clin Res Cardiol: 30 Oct 2019; 108:1240-1248
Jobs A, Abdin A, de Waha-Thiele S, Eitel I, ... de Wit C, Vonthein R
Clin Res Cardiol: 30 Oct 2019; 108:1240-1248 | PMID: 30895374
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Impact:
Abstract

Epicardial fat accumulation is an independent marker of impaired heart rate recovery in obese patients with obstructive sleep apnea.

Monfort A, Inamo J, Fagour C, Banydeen R, ... Rivkine E, Neviere R
Background
Sympathetic nervous system activation plays a pivotal role in obese patients with obstructive sleep apnea (OSA), contributing to increased cardiovascular risk. Epicardial adipose tissue (EAT) activates cardiac autonomic nervous system. Our main study objective was to investigate effects of these autonomic dysfunction factors on post-exercise heart rate recovery (HRR).
Methods
36 patients, referred for clinical assessment of obesity (BMI > 30 kg/m), underwent overnight polysomnography, transthoracic echocardiography and cardiopulmonary exercise testing.
Results
Compared to non-OSA patients, OSA patients were older and displayed reduced body weight-indexed peak VO. Cardiac output at peak exercise was similar among groups. Peak exercise arterio-venous oxygen content difference D[a-v]O was lower in OSA patients. In univariate linear analysis, age, AHI, EAT thickness, peak VO and diabetes were associated with blunted HRR. Multiple linear regression analysis showed that increased EAT thickness, AHI and diabetes were independently associated with lower HRR. For identical AHI value and diabetes status, HRR significantly decreased by 61.7% for every 1 mm increase of EAT volume (p = 0.011). If HRR was treated as a categorical variable, EAT [odds ratio (OR) 1.78 (95% confidence interval [CI] 1.19-2.66); p = 0.005], and type 2 diabetes [OR 8.97 (95% CI 1.16-69.10); p = 0.035] were the only independent predictors of blunted HRR.
Conclusions
Aerobic capacity and peak exercise D[a-v]O are impaired in obese OSA patients, suggesting abnormal peripheral oxygen extraction. EAT thickness is an independent marker of post-exercise HRR, which is a noninvasive marker of autonomic nerve dysfunction accompanying poor cardiovascular prognosis in obese patients.



Clin Res Cardiol: 30 Oct 2019; 108:1226-1233
Monfort A, Inamo J, Fagour C, Banydeen R, ... Rivkine E, Neviere R
Clin Res Cardiol: 30 Oct 2019; 108:1226-1233 | PMID: 30887111
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Impact:
Abstract

Implementation of an intensified outpatient follow-up protocol improves outcomes in patients with ventricular assist devices.

Hamed S, Schmack B, Mueller F, Ehlermann P, ... Raake PW, Kreusser MM
Background
Ventricular assist devices (VAD) are increasingly used as long-term treatment for advanced heart failure. However, survival after VAD implantation is still unsatisfactory, and no specific outpatient follow-up algorithms have been formally established. Here, we evaluate the effect of an intensified follow-up protocol (IFUP) on survival rates and VAD-associated complications.
Methods and results
This is a retrospective study of 57 patients who received a VAD at our center between February 2013 and December 2017. Inclusion criteria were discharge home after VAD implantation and follow-up in our VAD outpatient clinic. Patients implanted after October 2015 (n = 30) were monitored according to IFUP. This protocol embodied formalized, multi-disciplinary clinical visits every 4-8 weeks including a cardiologist, a cardiothoracic surgeon and a VAD-coordinator and was characterized by optimized anticoagulation and wound management as well as guideline-directed medical therapy. One-year survival in the IFUP patients was 97%, compared to 74% in the pre-IFUP era (p = 0.01). Implementation of IFUP was associated with a 90% risk-reduction for 1-year mortality (relative risk 0.099; p = 0.048). The rate of complications, e.g., device thrombosis and major bleeding, was significantly reduced, resulting in superior event-free survival in the IFUP group (p = 0.003). Furthermore, by implementation of IFUP, a more stable anticoagulation adjustment was achieved as well as an improved adherence to guideline-directed medical therapy.
Conclusion
Implementation of an IFUP for VAD patients is associated with a significant decrease in 1-year all-cause mortality. This emphasizes the need for more vigilance in the management of VAD patients by a dedicated multi-disciplinary team.



Clin Res Cardiol: 30 Oct 2019; 108:1197-1207
Hamed S, Schmack B, Mueller F, Ehlermann P, ... Raake PW, Kreusser MM
Clin Res Cardiol: 30 Oct 2019; 108:1197-1207 | PMID: 30879094
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Impact:
Abstract

Thrombus aspiration in patients with ST-elevation myocardial infarction presenting late after symptom onset: long-term clinical outcome of a randomized trial.

Freund A, Schock S, Stiermaier T, de Waha-Thiele S, ... Thiele H, Desch S
Background
In the largest randomized trial so far, thrombus aspiration failed to reduce the primary endpoint of microvascular obstruction (MVO) in patients with ST-elevation myocardial infarction (STEMI) presenting late after symptom onset. Long-term clinical outcome data of this trial have not been reported yet.
Methods and results
A total of 144 patients with STEMI presenting ≥ 12 and ≤ 48 h after symptom onset were randomized to primary percutaneous coronary intervention (PCI) with or without manual thrombus aspiration in a 1:1 fashion. The primary efficacy endpoint was the extent of MVO assessed by cardiac magnetic resonance imaging and showed no significant difference between groups. Long-term clinical follow-up was performed at 4 years. Overall mortality at 4 years reached 18%. There was no significant difference between groups with respect to mortality and major adverse cardiac events defined as the composite of death, myocardial reinfarction and target vessel revascularization. In a multivariate Cox regression model glomerular filtration rate on admission, left ventricular ejection fraction, and cardiogenic shock were independently associated with time-dependent occurrence of death.
Conclusion
Routine thrombus aspiration in STEMI patients presenting late after symptom onset showed no significant difference with respect to long-term clinical endpoints compared to conventional PCI only.



Clin Res Cardiol: 30 Oct 2019; 108:1208-1214
Freund A, Schock S, Stiermaier T, de Waha-Thiele S, ... Thiele H, Desch S
Clin Res Cardiol: 30 Oct 2019; 108:1208-1214 | PMID: 30859380
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Impact:
Abstract

Left atrial roof ablation in patients with persistent atrial fibrillation using the second-generation cryoballoon: benefit or wasted time?

Kuniss M, Akkaya E, Berkowitsch A, Zaltsberg S, ... Hamm CW, Neumann T
Introduction
It is unknown whether left atrial (LA) roof ablation combined with pulmonary vein isolation (PVI) using a second-generation cryoballoon provides additional benefit beyond that of PVI alone in patients with persistent atrial fibrillation (AF). The aim of this study was to compare arrhythmia recurrence rates after PVI alone versus PVI plus LA roof ablation.
Methods and results
In this observational study, we analyzed 399 symptomatic patients with persistent AF treated with cryoballoon ablation. After univariate and multivariate analyses of the entire cohort, propensity score matching resulted in two groups of 86 patients each: (1) PVI plus LA roof ablation (PVI-plus group) and (2) PVI alone (PVI-only group). The primary endpoint was the first documented > 30-s arrhythmia recurrence after a 3-month blanking period. PVI was successful in all patients. A bidirectional conduction block across the LA roof was verified in 91.9% of patients in the PVI-plus group. During a median mid-term follow-up of 33 months, 21 patients (24.4%) in the PVI-plus group and 37 patients (43.0%) in the PVI-only group (P = 0.01) reached the primary endpoint. Multivariate analysis revealed AF history > 2 years (hazard ratio [HR] = 2.04, P < 0.01), LA area > 21 cm (HR = 2.36, P < 0.01), female sex (HR = 1.92, P = 0.02), and LA roof ablation (HR = 0.47, P < 0.01) as significant predictors of outcome.
Conclusions
We observed a significant difference in arrhythmia recurrence rates between the two groups. LA roof ablation is an effective adjuvant treatment option that shows improved outcome compared with PVI alone.



Clin Res Cardiol: 29 Oct 2019; epub ahead of print
Kuniss M, Akkaya E, Berkowitsch A, Zaltsberg S, ... Hamm CW, Neumann T
Clin Res Cardiol: 29 Oct 2019; epub ahead of print | PMID: 31667623
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Impact:
Abstract

Early and late risk of ischemic stroke after TAVR as compared to a nationwide background population.

De Backer O, Butt JH, Wong YH, Torp-Pedersen C, ... Køber L, Søndergaard L

Ischemic stroke is a feared complication associated with transcatheter aortic valve replacement (TAVR). Data on the late risk of ischemic stroke following TAVR are scarce. This study aimed to investigate the early (0-90 days) and late (90 days-5 years) risk of ischemic cerebrovascular events (CVE) in a large, unselected cohort of patients undergoing TAVR and to compare this risk with a matched background population. Therefore, all patients undergoing first-time TAVR in Denmark were matched to a background population (controls) in a 1:4 ratio based on age, sex, atrial fibrillation (AF), and the major stroke risk factors. A total of 2455 TAVR patients were matched with 9820 controls. TAVR was associated with a significantly higher ischemic CVE risk as compared with their controls in the early phase [hazard ratio (HR) 5.35 [95% CI 3.50-8.17]; p < 0.001) but not in the late phase (HR 1.17 [95% CI 0.94-1.46]; p = 0.15). In a predefined stratified analysis, no patient-related factors were associated with this higher CVE risk in the early phase. The cumulative 90-day ischemic CVE risk was the lowest in TAVR-patients with known AF receiving oral anticoagulant (OAC) therapy (1.3% [95% CI 0.6-2.5%] and was two-fold higher in OAC-naïve TAVR-patients (2.4% [95% CI 1.8-3.3%] in patients without AF and 2.5% [95% CI 0.9-5.3%] in patients with AF). In conclusion, TAVR was associated with an increased risk of ischemic CVE in the early phase, but not in the late phase, as compared to their matched controls-OAC therapy reduced this early risk of ischemic CVE by half.



Clin Res Cardiol: 29 Oct 2019; epub ahead of print
De Backer O, Butt JH, Wong YH, Torp-Pedersen C, ... Køber L, Søndergaard L
Clin Res Cardiol: 29 Oct 2019; epub ahead of print | PMID: 31667622
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Impact:
Abstract

Correlation of machine learning computed tomography-based fractional flow reserve with instantaneous wave free ratio to detect hemodynamically significant coronary stenosis.

Baumann S, Hirt M, Schoepf UJ, Rutsch M, ... Overhoff D, Lossnitzer D
Background
Fractional flow reserve based on coronary CT angiography (CT-FFR) is gaining importance for non-invasive hemodynamic assessment of coronary artery disease (CAD). We evaluated the on-site CT-FFR with a machine learning algorithm (CT-FFR) for the detection of hemodynamically significant coronary artery stenosis in comparison to the invasive reference standard of instantaneous wave free ratio (iFR).
Methods
This study evaluated patients with CAD who had a clinically indicated coronary computed tomography angiography (cCTA) and underwent invasive coronary angiography (ICA) with iFR-measurements. Standard cCTA studies were acquired with third-generation dual-source computed tomography and analyzed with on-site prototype CT-FFR software.
Results
We enrolled 40 patients (73% males, mean age 67 ± 12 years) who had iFR-measurement and CT-FFR calculation. The mean calculation time of CT-FFR values was 11 ± 2 min. The CT-FFR algorithm showed, on per-patient and per-lesion level, respectively, a sensitivity of 92% (95% CI 64-99%) and 87% (95% CI 59-98%), a specificity of 96% (95% CI 81-99%) and 95% (95% CI 84-99%), a positive predictive value of 92% (95% CI 64-99%), and 87% (95% CI 59-98%), and a negative predictive value of 96% (95% CI 81-99%) and 95% (95% CI 84-99%). The area under the receiver operating characteristic curve for CT-FFR on per-lesion level was 0.97 (95% CI 0.91-1.00). Per lesion, the Pearson\'s correlation between the CT-FFR and iFR showed a strong correlation of r = 0.82 (p < 0.0001; 95% CI 0.715-0.920).
Conclusion
On-site CT-FFR correlated well with the invasive reference standard of iFR and allowed for the non-invasive detection of hemodynamically significant coronary stenosis.



Clin Res Cardiol: 28 Oct 2019; epub ahead of print
Baumann S, Hirt M, Schoepf UJ, Rutsch M, ... Overhoff D, Lossnitzer D
Clin Res Cardiol: 28 Oct 2019; epub ahead of print | PMID: 31664509
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Impact:
Abstract

A novel risk score to predict survival in advanced heart failure due to cardiac amyloidosis.

Kreusser MM, Volz MJ, Knop B, Ehlermann P, ... Katus HA, Raake PW
Background
Cardiac amyloidosis, caused by deposition of immunoglobulin light chains (AL) or transthyretin (ATTR), carries a poor prognosis. Established risk scores for amyloidosis may not predict outcomes in those patients who develop advanced heart failure and who are potential candidates for heart transplantation. Here, we aimed to identify predictive parameters for patients with severe heart failure due to amyloidosis.
Methods
Out of > 1000 patients with cardiac amyloidosis (AL or ATTR) admitted to our centre between September 1998 and January 2016, a cohort of 120 patients with a complete cardiac assessment at diagnosis, including right heart catheterization, echocardiography and biomarkers, was analysed retrospectively in this study. Primary endpoint was all-cause mortality. We performed univariate and multivariate Cox regression analysis, generated risk scores to predict outcomes in AL and ATTR amyloidosis and compared those to established risk models for amyloidosis.
Results
In the Cox multivariate model, high-sensitivity troponin T (hsTnT; hazard ratio (HR) 1.003; confidence interval (CI) 1.001-1.005; p = 0.009) and mean pulmonary artery pressure (HR 1.061; CI 1.024-1.100; p = 0.001) were found to significantly and independently predict outcomes for AL amyloidosis, whereas QRS duration (HR 1.021; CI 1.004-1.039; p = 0.013), hsTnT (HR 1.021; CI 1.006-1.036; p = 0.006) and N-terminal pro-brain natriuretic peptide (HR 1.0003; CI 1.0001-1.0004; p = 0.002) were the best predictors for ATTR amyloidosis. A simple risk score (\"HeiRisk\") including these parameters for AL and ATTR allowed a more precise risk stratification in our patient population compared to established risk models.
Conclusions
Risk stratification for cardiac amyloidosis with the newly developed \"HeiRisk\" score may be superior to other staging systems for patients with advanced heart failure due to amyloid cardiomyopathy.



Clin Res Cardiol: 18 Oct 2019; epub ahead of print
Kreusser MM, Volz MJ, Knop B, Ehlermann P, ... Katus HA, Raake PW
Clin Res Cardiol: 18 Oct 2019; epub ahead of print | PMID: 31630214
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Impact:
Abstract

The potential prognostic utility of salivary galectin-3 concentrations in heart failure.

Zhang X, Karunathilaka N, Senanayake S, Subramaniam VN, ... Atherton JJ, Punyadeera C
Background
Patients with HF are at a higher risk of rehospitalisation and, as such, significant costs to our healthcare system. A non-invasive method to collect body fluids and measure Gal-3 could improve the current management of HF. In this study, we investigated the potential prognostic utility of salivary Galectin-3 (Gal-3) in patients with heart failure (HF).
Methods
We collected saliva samples from patients with HF (n = 105) either at hospital discharge or during routine clinical visits. Gal-3 concentrations in saliva samples were measured by ELISA. The Kaplan-Meier survival curve analysis and Cox proportional regression model were used to determine the potential prognostic utility of salivary Gal-3 concentrations.
Results
The primary end point was either cardiovascular death or hospitalisation. Salivary Gal-3 concentrations were significantly higher (p < 0.05) in patients with HF who subsequently experienced the primary endpoint compared to those who did not. HF patients with salivary Gal-3 concentrations > 172.58 ng/mL had a significantly (p < 0.05) higher cumulative risk of the primary endpoint compared to those with lower salivary Gal-3 concentrations. In patients with HF, salivary Gal-3 concentration was a predictor of the primary endpoint even after adjusting for other covariates.
Conclusions
In our pilot study, HF patients with salivary Gal-3 concentrations of > 172.58 ng/mL demonstrated a higher cumulative risk of the primary outcome compared to those with lower Gal-3 levels, even after adjusting for other variables. Confirming our findings in a larger multi-centre clinical trial in the future would enable salivary Gal-3 measurements to form part of routine management for patients with HF.



Clin Res Cardiol: 08 Oct 2019; epub ahead of print
Zhang X, Karunathilaka N, Senanayake S, Subramaniam VN, ... Atherton JJ, Punyadeera C
Clin Res Cardiol: 08 Oct 2019; epub ahead of print | PMID: 31598750
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Impact:
Abstract

Performance of the entirely subcutaneous ICD in borderline indications.

Willy K, Reinke F, Bögeholz N, Köbe J, Eckardt L, Frommeyer G
Background
The subcutaneous ICD (S-ICD™) is an important advance in device therapy for prevention of sudden cardiac death (SCD). In some patients, decision pro- or contra-ICD implantation is particularly challenging due to inconsistent data on risk of ventricular tachyarrhythmias or sudden cardiac death, rare entities, special medical or family history, or patients\' wishes. Whether decision-making in these borderline cases has been facilitated with the new option of a S-ICD™ is unknown.
Material and methods
All patients with an implanted S-ICD™ without a class I or IIa recommendation for primary prophylaxis of sudden cardiac death in the current guidelines (n = 30 patients) in our large-scaled single-centre S-ICD™ registry (n = 249 patients) were included in this study. Baseline characteristics, appropriate and inappropriate shocks, and complications were documented in a mean follow-up of 40 months.
Results
In all patients S-ICD™ implantation was performed for primary prevention of SCD. Of all 30 patients with an overall mean age of 40.5 ± 15.6 years, 17 were male (57%). The mean left ventricular ejection fraction (LVEF) was 54.5 ± 9.9%. Indication were highly variable and ranged from structural heart disease, nsVT and LV-EF > 35% to patients with polymorphic non-sustained ventricular tachycardia (nsVT) and suspect syncope. During follow-up, six episodes of sustained ventricular tachyarrhythmias and four episodes of ventricular fibrillation (VF) were adequately terminated in three patients (10%). Two of these patients were implanted for polymorphic nsVT and previous syncope without structural heart disease. In three patients, T-wave-oversensing and in one patient also P-wave-oversensing resulted in an inappropriate shock (five in total), two additional episodes of oversensing ended before shock delivery. There were no S-ICD™ system-related infections. In five patients S-ICD™ replacement was performed due to battery depletion (four regular, one premature). In five patients, ablation procedures were performed after implantation (four because of frequent symptomatic ventricular extra beats, one because of atrial flutter). Change to a transvenous system was necessary in two patients due to need for antibradycardia pacing.
Conclusion
The use of the S-ICD™ was safe in patients with borderline or unclear indication for ICD implantation in our study. Of note, during a relatively short mean follow-up there were several appropriate therapies, especially for VF in these patients. On the other hand, oversensing also occurred in about 10% of patients, while lead problems were not problematic in this collective. S-ICD™ implantation may be considered as a possible alternative in cases of borderline indications and clinical uncertainty when decision pro-ICD implantation is made. Incidence of arrhythmias was quite high and mostly consisted of VF. Nevertheless, patient education seems even more important as there is a considerable risk for inappropriate therapies as well.



Clin Res Cardiol: 03 Oct 2019; epub ahead of print
Willy K, Reinke F, Bögeholz N, Köbe J, Eckardt L, Frommeyer G
Clin Res Cardiol: 03 Oct 2019; epub ahead of print | PMID: 31586219
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Impact:
Abstract

Lower mortality in an all-comers aortic stenosis population treated with TAVI in comparison to SAVR.

Möllmann H, Husser O, Blumenstein J, Liebetrau C, ... Achenbach S, Gaede L
Background
Within the last years TAVI-especially transfemoral/transvascular TAVI-has proven to be a valuable therapeutic option for most patients suffering from AS. Here, we present the outcome of a complete dataset of all patients undergoing aortic valve replacement in Germany in 2018.
Methods
The data of all aortic valve procedures performed in Germany in 2018 derive from the mandatory nationwide quality control program. Patients were stratified with a new version of the German Aortic valve score (AKL Score) divided in different risk stratification depending on the treatment with either a catheter based (TV-TAVI) or surgical (iSAVR) approach. In-hospital outcomes have been compared between the two approaches.
Results
19,317 transvascular (TV)-TAVI procedures were carried out. In contrast to this steady growth, the number of iSAVR andtransapical (TA) -TAVI procedures declined. In-hospital mortality after TV-TAVI (2.5%) was lower when compared to iSAVR (3.1%) as well as TA-TAVI (5.7%) in-hospital mortality after TV-TAVI was significantly lowest (Fig. 2) with an in-hospital mortality rate of 2.5%. TV-TAVI was the only approach with an observed vs. expected mortality ratio < 1 according to the used risk prediction model.
Conclusion
TV-TAVI is more often performed and shows lower in-hospital mortality than iSAVR. TV-TAVI has replaced iSAVR as the gold-standard concerning in-hospital outcome in aortic stenosis management.



Clin Res Cardiol: 30 Sep 2019; epub ahead of print
Möllmann H, Husser O, Blumenstein J, Liebetrau C, ... Achenbach S, Gaede L
Clin Res Cardiol: 30 Sep 2019; epub ahead of print | PMID: 31573055
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Impact:
Abstract

Two birds with one stone: transcatheter valve-in-valve treatment of a failed surgical bioprosthesis with concomitant severe stenosis and paravalvular leak.

Alvarez-Covarrubias HA, Xhepa E, Michel JM, Kasel AM

Implantation of bioprosthetic surgical valves has been a common procedure in elderly patients with severe aortic stenosis due to patients´ preferences avoiding anticoagulation therapy. However, this valve presents sometime certain deterioration degree (i.e., dysfunction due to stenosis or regurgitation) or even paravalvular leak. Transcatheter heart valve implantation is a good alternative in high-risk patients. The valve-in-valve procedure has been shown to be a safe and effective procedure. However, the presence of the fixed sewing ring of the surgical bioprosthesis can hamper appropriate expansion of the THV. For this reason, the use of cracking balloon seems to be a safe alternative to increase the effective orifice area. We present a case of a patient with a degenerated previous implanted biological valve and paravalvular leak. We used the treatment strategy of valve-in-valve with post-dilatation with high-pressure balloon, in a way to treat both, the degenerated valve and the paravalvular leak. The use of a single percutaneous procedure was enough and safe to treat both problems without further complications.



Clin Res Cardiol: 29 Sep 2019; 108:1069-1073
Alvarez-Covarrubias HA, Xhepa E, Michel JM, Kasel AM
Clin Res Cardiol: 29 Sep 2019; 108:1069-1073 | PMID: 31267238
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Impact:
Abstract

Long-term follow-up of implantable cardioverter-defibrillators in Short QT syndrome.

El-Battrawy I, Besler J, Ansari U, Liebe V, ... Borggrefe M, Akin I
Background
Short QT syndrome (SQTS) is associated with sudden cardiac death and implantable cardioverter-defibrillator (ICD) implantation is recommended in this rare disease. However, only a few SQTS families have been reported in literature with limited follow-up data.
Objectives
In the recent study, we describe the outcome data of 57 SQTS patients receiving ICD implantation. This includes seven SQTS families consecutively admitted to our hospital between 2002 and 2017 as well as patients reported in published literature.
Methods
Seven SQTS patients admitted to our hospital were followed up. Additionally, 7 studies out of a total of 626 researched articles were identified through systematic database search (PubMed, Web of Science, Cochrane Library, and Cinahl) and their data analyzed according to our model.
Results
Complications during a median follow-up time of 67.4 months (IQR 6-162 months) were documented in 31 (54%) patients. Inappropriate shocks were seen in 33% due to T wave oversensing (8.7%), supraventricular tachycardia (19%), lead failure and fracture (21%). Further complications were infection (10%), battery depletion (7%) and psychological distress (3.5%). Appropriate shocks were documented in 19%. Three patients (5%) were treated with s-ICD due to recurrent complications of transvenous ICD.
Conclusion
ICD therapy is an effective therapy in SQTS patients. However, it is also associated with significant risk of device-related complications.



Clin Res Cardiol: 29 Sep 2019; 108:1140-1146
El-Battrawy I, Besler J, Ansari U, Liebe V, ... Borggrefe M, Akin I
Clin Res Cardiol: 29 Sep 2019; 108:1140-1146 | PMID: 30879093
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Impact:
Abstract

Implant-based multi-parameter telemonitoring of patients with heart failure and a defibrillator with vs. without cardiac resynchronization therapy option: a subanalysis of the IN-TIME trial.

Geller JC, Lewalter T, Bruun NE, Taborsky M, ... Hindricks G,
Aims
In the IN-TIME trial, automatic daily implant-based multiparameter telemonitoring significantly improved clinical outcomes in patients with chronic systolic heart failure and implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D). We compared IN-TIME results for ICD and CRT-D subgroups.
Methods
Patients with LVEF ≤ 35%, NYHA class II/III, optimized drug treatment, no permanent atrial fibrillation, and a dual-chamber ICD (n = 274) or CRT-D (n = 390) were randomized 1:1 to telemonitoring or no telemonitoring for 12 months. Primary outcome measure was a composite clinical score, classified as worsened if the patient died or had heart failure-related hospitalization, worse NYHA class, or a worse self-reported overall condition.
Results
The prevalence of worsened score at study end was higher in CRT-D than ICD patients (26.4% vs. 18.2%; P = 0.014), as was mortality (7.4% vs. 4.1%; P = 0.069). With telemonitoring, odds ratios (OR) for worsened score and hazard ratios (HR) for mortality were similar in the ICD [OR = 0.55 (P = 0.058), HR = 0.39 (P = 0.17)] and CRT-D [OR = 0.68 (P = 0.10), HR = 0.35 (P = 0.018)] subgroups (insignificant interaction, P = 0.58-0.91).
Conclusion
Daily multiparameter telemonitoring has a potential to reduce clinical endpoints in patients with chronic systolic heart failure both in ICD and CRT-D subgroups. The absolute benefit seems to be higher in higher-risk populations with worse prognosis.



Clin Res Cardiol: 29 Sep 2019; 108:1117-1127
Geller JC, Lewalter T, Bruun NE, Taborsky M, ... Hindricks G,
Clin Res Cardiol: 29 Sep 2019; 108:1117-1127 | PMID: 30874886
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Impact:
Abstract

Biventricular myocardial strain analysis using cardiac magnetic resonance feature tracking (CMR-FT) in patients with distinct types of right ventricular diseases comparing arrhythmogenic right ventricular cardiomyopathy (ARVC), right ventricular outflow-tract tachycardia (RVOT-VT), and Brugada syndrome (BrS).

Heermann P, Fritsch H, Koopmann M, Sporns P, ... Schulze-Bahr E, Schülke C
Objectives
As underlying heart diseases of right ventricular tachyarrhythmias, ARVC causes wall-motion abnormalities based on fibrofatty myocardial degeneration, while RVOT-VT and BrS are thought to lack phenotypic MR characteristics. To examine whether cardiac magnetic resonance (CMR) feature tracking (FT) in addition to ARVC objectively facilitates detection of myocardial functional impairments in RVOT-VT and BrS.
Methods
Cine MR datasets of four retrospectively enrolled, age-matched study groups [n = 65; 16 ARVC, 26 RVOT-VT, 9 BrS, 14 healthy volunteers (HV)] were independently assessed by two distinctly experienced investigators regarding myocardial function using CMR-FT. Global strain (%) and strainrate (s) in radial and longitudinal orientation were assessed at RVOT as well as for left (LV) and right (RV) ventricle at a basal, medial and apical section with the addition of a biventricular circumferential orientation.
Results
RV longitudinal and radial basal strain (%) in ARVC (- 12.9 ± 4.2; 11.4 ± 5.1) were significantly impaired compared to RVOT-VT (- 18.0 ± 2.5, p ≤ 0.005; 16.4 ± 5.2, p ≤ 0.05). Synergistically, RVOT endocardial radial strain (%) in ARVC (33.8 ± 22.7) was significantly lower (p ≤ 0.05) than in RVOT-VT (54.3 ± 14.5). For differentiation against BrS, RV basal and medial radial strain values (%) (13.3 ± 6.1; 11.8 ± 2.9) were significantly reduced when compared to HV (21.0 ± 6.9, p ≤ 0.05; 20.1 ± 6.6, p ≤ 0.005), even in case of a normal RV ejection fraction (EF) (> 45%; n = 6) (12.0 ± 2.7 vs. 20.1 ± 6.6, p ≤ 0.05).
Conclusions
CMR-FT facilitates relevant differentiation in patients with right ventricular tachyarrhythmias: between ARVC against RVOT-VT and HV as well as between BrS with even a preserved EF against HV.



Clin Res Cardiol: 29 Sep 2019; 108:1147-1162
Heermann P, Fritsch H, Koopmann M, Sporns P, ... Schulze-Bahr E, Schülke C
Clin Res Cardiol: 29 Sep 2019; 108:1147-1162 | PMID: 30868222
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Impact:
Abstract

Differential effects of inhibition of interleukin 1 and 6 on myocardial, coronary and vascular function.

Ikonomidis I, Pavlidis G, Katsimbri P, Andreadou I, ... Alexopoulos D, Iliodromitis E
Background
Anakinra, an interleukin-1 receptor antagonist and tocilizumab, an interleukin-6 receptor blocker, are used for the treatment of rheumatoid arthritis. We investigated the differential effects of anakinra and tocilizumab on myocardial and vascular function in an atherosclerosis model of patients with rheumatoid arthritis.
Methods
120 patients with rheumatoid arthritis were randomized to anakinra (n = 40), tocilizumab (n = 40) or prednisolone (n = 40) for 3 months. Primary outcome measure was the change of left ventricular longitudinal strain after 3 months of treatment. Additionally, we measured coronary flow reserve, flow-mediated dilatation of the brachial artery, carotid-femoral pulse wave velocity, malondialdehyde and protein carbonyls as oxidative stress markers and C-reactive protein blood levels at baseline and post-treatment.
Results
At baseline, patients among the three treatment arms had similar age, sex, disease activity score and atherosclerotic risk factors. Compared with baseline, all patients had improved longitudinal strain (- 16% vs. - 17.8%), coronary flow reserve (2.56 vs. 2.9), malondialdehyde (2.0 vs. 1.5 µM/L), protein carbonyls (0.0132 vs. 0.0115 nmol/mg), and C-reactive protein post-treatment. In all patients, the percent decrease of malondialdehyde was correlated with percent increase of longitudinal strain (p < 0.001). Compared with tocilizumab and prednisolone, anakinra treatment resulted in a greater improvement of longitudinal strain (18.7% vs. 9.7% vs. 6%) and coronary flow reserve (29% vs. 13% vs. 1%), while pulse wave velocity and brachial blood pressure were improved only after tocilizumab treatment (11 ± 3 vs. 10.3 ± 2 m/s p < 0.05 for all comparisons).
Conclusions
Anakinra is associated with an improvement in cardiac function and tocilizumab with improvement in vascular function.
Clinical trial registration
URL: https:// http://www.clinicaltrials.gov . Unique identifier: NCT03288584.



Clin Res Cardiol: 29 Sep 2019; 108:1093-1101
Ikonomidis I, Pavlidis G, Katsimbri P, Andreadou I, ... Alexopoulos D, Iliodromitis E
Clin Res Cardiol: 29 Sep 2019; 108:1093-1101 | PMID: 30859382
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Impact:
Abstract

Cardioprotective effect of renin-angiotensin inhibitors and β-blockers in trastuzumab-related cardiotoxicity.

Ohtani K, Ide T, Hiasa KI, Sakamoto I, ... Kubo M, Tsutsui H
Background
Trastuzumab-related cardiotoxicity (TRC) has been considered as reversible. However, recent studies have raised concern against reversibility of left ventricular (LV) systolic dysfunction in breast cancer patients treated with trastuzumab. In addition, the efficacy of medical treatment for heart failure (HF) including renin-angiotensin inhibitors and β-blockers has not been defined in TRC.
Methods and results
We retrospectively studied 160 patients with breast cancer receiving trastuzumab in the adjuvant (n = 129) as well as metastatic (n = 31) settings in our institution from 2006 to 2015. During the median follow-up of 3.5 years, 20 patients (15.5%) receiving adjuvant trastuzumab and 7 patients (22.6%) with metastatic breast cancer developed TRC with a mean decrease in LV ejection fraction (EF) of 19.8%. By the multivariate analysis, lower LVEF before trastuzumab (OR 1.30; 95% CI 1.16-1.48; P = 0.0001) independently predicted subsequent development of TRC. LV systolic dysfunction was reversible in 20 patients (74.1%) with a median time to recovery of 7 months, which was independently associated with lower dose of anthracyclines (OR 1.03; 95% CI 1.01-1.07, P = 0.020) and an introduction of renin-angiotensin inhibitors and β-blockers (OR 19.0; 95% CI 1.00-592.2, P = 0.034).
Conclusions
Irreversible decline in LVEF occurred in patients who underwent trastuzumab in combination with anthracyclines with a relatively high frequency. The lower cumulative dose of anthracyclines and HF treatment including renin-angiotensin inhibitors and β-blockers were both independent predictors to enhance LV functional reversibility in patients with TRC.



Clin Res Cardiol: 29 Sep 2019; 108:1128-1139
Ohtani K, Ide T, Hiasa KI, Sakamoto I, ... Kubo M, Tsutsui H
Clin Res Cardiol: 29 Sep 2019; 108:1128-1139 | PMID: 30859381
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Impact:
Abstract

Left ventricular geometry and function in early repolarization: results from the population-based Gutenberg Health Study.

Trenkwalder T, Rübsamen N, Schmitt VH, Arnold N, ... Reinhard W, Schnabel R
Aims
The electrocardiographic pattern of early repolarization (ER) is related to increased cardiac mortality in the general population. The pathophysiological basis of ER is largely unknown. We investigated the association of echocardiographic structural and functional parameters of the left ventricle with the presence of ER in the community.
Methods and results
The presence of ER (ER+) was assessed in 13,878 participants (mean age 54.6 years, 51.1% women) of the Gutenberg Health Study and related to left ventricular structure and function derived from standard echocardiography. The prevalence of ER was 5.0% (694/13,878), with higher prevalence in men than women (6.6% vs. 3.5%, p < 0.001). In men baseline characteristics differed including a lower BMI and a lower heart rate in ER+ individuals, whereas in women there were only minor differences. Multivariable-adjusted logistic regression analysis in men showed an association of ER with smaller diameters (left-ventricular end-diastolic diameter: OR 0.77 95% CI 0.69-0.86, p < 0.001; left-ventricular end-systolic diameter: OR 0.86 95% CI 0.78-0.95, p = 0.0035), and lower left-ventricular end-diastolic and end-systolic volume (OR 0.72 95% CI 0.65, 0.80, p < 0.001 and OR 0.80 95% CI 0.72, 0.89, p < 0.001). In women, the associations of ER with left ventricular diameters and volumes showed a similar direction, but were not as pronounced.
Conclusion
In the community, the ER pattern predominantly occurs in men with a low heart rate and a slender habit. Furthermore, ER is not associated with higher left ventricular mass or size but rather with smaller left ventricular diameters and volumes with a regular systolic and diastolic function. Patterns were comparable in women, but less strong.



Clin Res Cardiol: 29 Sep 2019; 108:1107-1116
Trenkwalder T, Rübsamen N, Schmitt VH, Arnold N, ... Reinhard W, Schnabel R
Clin Res Cardiol: 29 Sep 2019; 108:1107-1116 | PMID: 30820639
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Impact:
Abstract

Higher prevalence of heart failure in rural regions: a population-based study covering 87% of German inhabitants.

Holstiege J, Akmatov MK, Störk S, Steffen A, Bätzing J
Background
So far the extent of regional variation of heart failure (HF) prevalence in Germany is unknown.
Methods
Using a full sample of nationwide claims data covering ambulatory care of approximately 87% of the German population, this study aimed to (i) examine regional differences of HF prevalence on the level of 402 German administrative districts and (ii) investigate factors associated with HF prevalence. This study included all statutory health-insured patients aged ≥ 40 years in 2017, comprising about 40 million individuals. Age- and sex-standardized HF prevalence was estimated on the district level. Two-level logistic regression analysis was employed to study the influence of the district-related factors degree of urbanisation and regional socio-economic status on HF diagnosis, adjusted for the individual\'s age and sex.
Results
HF prevalence in 2017 was 6.0%. Standardized prevalence on the district level varied by a factor of 4.3 (range 2.8-11.9%). Regional socio-economic status and degree of urbanisation were independently associated with HF prevalence. The prevalence increased with decreasing degree of urbanisation. The adjusted risk of suffering from HF was 40% higher in \'rural areas with a low population density\' as compared to \'big urban municipalities\' (odds ratio 1.40, 99% CI 1.24-1.59).
Conclusion
Strong regional variations in HF prevalence may inform future public health policies regarding targeted resource planning and prevention strategies. High prevalence in areas with low population density adds to the challenge of ensuring universal access to health services in rural German regions.



Clin Res Cardiol: 29 Sep 2019; 108:1102-1106
Holstiege J, Akmatov MK, Störk S, Steffen A, Bätzing J
Clin Res Cardiol: 29 Sep 2019; 108:1102-1106 | PMID: 30798347
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Impact:
Abstract

Digitalis therapy is associated with higher comorbidities and poorer prognosis in patients undergoing ablation of atrial arrhythmias: data from the German Ablation Registry.

Frommeyer G, Brachmann J, Ince H, Spitzer SG, ... Senges J, Eckardt L
Background
Digitalis glycosides are employed for rate control of atrial fibrillation. Recent studies suggested potential harmful effects of digitalis monotherapy and combination with antiarrhythmic drugs. The aim of the present study was to assess the prevalence and potential impact of digitalis therapy on outcome in patients undergoing catheter ablation of supraventricular arrhythmias.
Methods and results
The German Ablation Registry is a nationwide, prospective registry with a 1-year follow-up investigating 12,566 patients receiving catheter ablations of supraventricular arrhythmias in 52 German centres. The present analysis focussed on pharmacotherapy in 8608 patients undergoing catheter ablation of atrial tachycardia, atrial fibrillation, or atrial flutter. Patients receiving digitalis therapy (n = 417) were older and presented a significantly increased prevalence of comorbidities including coronary artery disease, heart failure, diabetes, and pulmonary disease. One-year mortality was significantly higher in digitalis-treated patients (4.7% vs. 1.3%, p < 0.001), most strikingly in patients undergoing ablation of atrial flutter. This effect was maintained after adjustment for important risk factors. Similar results were obtained for as the combined endpoint of death, myocardial infarction, stroke and major bleeding (6.6% vs. 2.7%, p < 0.001), and non-fatal rehospitalisations (54.1% vs. 45.1%, p = 0.001).
Conclusion
In the present study of patients undergoing catheter ablation of supraventricular arrhythmias, an association of digitalis therapy with increased mortality and an increased rate of other severe adverse events were observed. The results from this \'real-life\' registry are consistent with previously published studies. However, whether digitalis therapy promotes a poorer prognosis or may just serve as a marker for this aspect cannot be thoroughly interpreted.



Clin Res Cardiol: 29 Sep 2019; 108:1083-1092
Frommeyer G, Brachmann J, Ince H, Spitzer SG, ... Senges J, Eckardt L
Clin Res Cardiol: 29 Sep 2019; 108:1083-1092 | PMID: 30798346
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Impact:
Abstract

Sacubitril/valsartan reduces ventricular arrhythmias in parallel with left ventricular reverse remodeling in heart failure with reduced ejection fraction.

Martens P, Nuyens D, Rivero-Ayerza M, Van Herendael H, ... Dupont M, Mullens W
Background
Sacubitril/valsartan reduced the occurrence of sudden cardiac death in the PARADIGM-HF trial. However, limited information is available about the mechanism.
Methods
Heart failure (HF)-patients receiving sacubitril/valsartan for a class-I indication equipped with an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) with remote tele-monitoring were retrospectively analyzed. Device-registered arrhythmic-events were determined [ventricular tachycardia/fibrillation (VT/VF), appropriate therapy, non-sustained VT (NsVT; > 4beats and < 30 s), hourly premature ventricular contraction (PVC)-burden], following sacubitril/valsartan initiation (incident-analysis) and over an equal time period before initiation (antecedent-analysis). Reverse remodeling to sacubitril/valsartan was defined as an improvement of left ventricular ejection fraction of ≥ 5% between baseline and follow-up.
Results
A-total of 151 HF-patients with reduced LVEF (29 ± 9%) were included. Patients were switched from ACE-I or ARB to equal doses of sacubitril/valsartan (expressed as %-target-dose; before = 58 ± 30% vs. after = 56 ± 27%). The mean follow-up of both the incident and antecedent analysis was 364 days. Following the initiation, VT/VF-burden dropped (individual patients with VT/VF pre_n = 19 vs. post_n = 10, total-episodes of VT/VF pre_n = 51 vs. post_n = 14, both p < 0.001), resulting in reduced occurrence of appropriate therapy (pre_n = 16 vs. post_n = 6; p < 0.001). NsVT-burden per patient also dropped (mean episodes pre_n = 7.7 ± 11.8 vs. post_n = 3.7 ± 5.4; p < 0.001). There was no impact on atrial-fibrillation burden. PVC-burden dropped significantly which was associated with an improvement in BiV-pacing in patients with < 90% BiV-pacing at baseline. A higher degree of reverse remodeling was associated with a lower burden of NsVT and PVCs (both p < 0.05).
Conclusion
Initiation of sacubitril/valsartan is associated with a lower degree of VT/VF, resulting in less ICD-interventions. This beneficial effect on ventricular arrhythmias might be related to cardiac reverse remodeling.



Clin Res Cardiol: 29 Sep 2019; 108:1074-1082
Martens P, Nuyens D, Rivero-Ayerza M, Van Herendael H, ... Dupont M, Mullens W
Clin Res Cardiol: 29 Sep 2019; 108:1074-1082 | PMID: 30788621
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Impact:
Abstract

Circulatory factors associated with function and prognosis in patients with severe heart failure.

Rullman E, Melin M, Mandić M, Gonon A, Fernandez-Gonzalo R, Gustafsson T
Background
Multiple circulatory factors are increased in heart failure (HF). Many have been linked to cardiac and/or skeletal muscle tissue processes, which in turn might influence physical activity and/or capacity during HF. This study aimed to provide a better understanding of the mechanisms linking HF with the loss of peripheral function.
Methods and results
Physical capacity measured by maximum oxygen uptake, myocardial function (measured by echocardiography), physical activity (measured by accelerometry), and mortality data was collected for patients with severe symptomatic heart failure an ejection fraction < 35% (n = 66) and controls (n = 28). Plasma circulatory factors were quantified using a multiplex immunoassay. Multivariate (orthogonal projections to latent structures discriminant analysis) and univariate analyses identified many factors that differed significantly between HF and control subjects, mainly involving biological functions related to cell growth and cell adhesion, extracellular matrix organization, angiogenesis, and inflammation. Then, using principal component analysis, links between circulatory factors and physical capacity, daily physical activity, and myocardial function were identified. A subset of ten biomarkers differentially expressed in patients with HF vs controls covaried with physical capacity, daily physical activity, and myocardial function; eight of these also carried prognostic value. These included established plasma biomarkers of HF, such as NT-proBNP and ST2 along with recently identified factors such as GDF15, IGFBP7, and TfR, as well as a new factor, galectin-4.
Conclusions
These findings reinforce the importance of systemic circulatory factors linked to hemodynamic stress responses and inflammation in the pathogenesis and progress of HF disease. They also support established biomarkers for HF and suggest new plausible markers.



Clin Res Cardiol: 26 Sep 2019; epub ahead of print
Rullman E, Melin M, Mandić M, Gonon A, Fernandez-Gonzalo R, Gustafsson T
Clin Res Cardiol: 26 Sep 2019; epub ahead of print | PMID: 31562542
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Abstract

Optimizing heart failure treatment following cardiac resynchronization therapy.

Jorsal A, Pryds K, McMurray JJV, Wiggers H, ... Nielsen JC, Nielsen RR
Background
Device therapy in addition to medical treatment improves prognosis in a subset of patients with heart failure and reduced ejection fraction. However, some patients remain symptomatic or their heart failure even progresses despite cardiac resynchronization therapy (CRT). The aim of the study was to evaluate the proportion of patients who could benefit from optimization of medical therapy using sacubitril/valsartan, ivabradine, or both following CRT implantation.
Methods
We conducted a post hoc analysis of a single-centre, patient and outcome-assessor blinded, randomized-controlled trial, in which patients scheduled for CRT were randomized to empiric (n = 93) or imaging-guided left-ventricular lead placement (n = 89). All patients underwent clinical evaluation and blood sampling at baseline and 6 months following CRT implantation. The proportion of patients meeting the indication for sacubitril/valsartan (irrespective of angiotensin-converting enzyme inhibitor or angiotensin 2 receptor blocker dosage) and/or ivabradine according to current guidelines was evaluated at baseline and after 6 months.
Results
Of 182 patients with an indication for CRT, 146 (80%) also had an indication for optimization of medical therapy at baseline by adding sacubitril/valsartan, ivabradine, or both. Of the 179 survivors at 6 months, 136 (76%) were still symptomatic after device implantation; of these, 51 (38%) patients had an indication for optimization of medical therapy: sacubitril/valsartan in 37 (27%), ivabradine in 7 (5%), and both drugs in 7 (5%) patients. Seven (18%) patients without indication at baseline developed an indication for medical optimization 6 months after CRT implantation.
Conclusion
In the present study, 38% of those who remained symptomatic 6 months after CRT implantation were eligible for optimization of medical therapy with sacubitril/valsartan, ivabradine, or both. Patients with CRT may benefit from systematic follow-up including evaluation of medical treatment.



Clin Res Cardiol: 25 Sep 2019; epub ahead of print
Jorsal A, Pryds K, McMurray JJV, Wiggers H, ... Nielsen JC, Nielsen RR
Clin Res Cardiol: 25 Sep 2019; epub ahead of print | PMID: 31559483
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Impact:
Abstract

Three-dimensional speckle-tracking echocardiography for the global and regional assessments of left ventricle myocardial deformation in breast cancer patients treated with anthracyclines.

Coutinho Cruz M, Moura Branco L, Portugal G, Galrinho A, ... Luz R, Cruz Ferreira R
Background
Assessment of 2D/3D left ventricular ejection fraction (LVEF) and 2D global longitudinal strain (GLS) is the gold standard for diagnosing cancer therapeutics-related cardiac dysfunction (CTRCD). Although 3D speckle-tracking echocardiography (STE) has several advantages, it is not used in this setting.
Methods
105 breast cancer patients who underwent serial echocardiographic assessment during anthracycline therapy were included. STE was used to estimate 2D GLS, 3D GLS, 3D global circumferential strain (GCS), 3D global radial strain (GRS), and 3D global area strain (GAS). CTRCD was defined as an absolute decrease in 2D/3D LVEF > 10% to a value < 54% or a relative decrease in 2D GLS > 15%.
Results
24 patients developed CTRCD. There was a significant worsening of all 3D strain parameters during chemotherapy. 3D strain regional analysis showed impaired contractility in the anterior, inferior, and septal walls. Variations of 3D GRS and 3D GCS were associated with a higher incidence of CTRCD and the variation of 3D GRS was an independent predictor of CTRCD. Variations of 3D GCS and 3D GRS had a good discrimination for predicting CTRCD, with optimal cutoff values of - 34.2% for 3D GCS and - 34.4% for 3D GRS. These variations were observed 45 and 23 days before the diagnosis of CTRCD, respectively.
Conclusion
Variations of 3D strain parameters were predictive of and preceded CTRCD, and thus have added value over currently recommended 2D/3D LVEF and 2D GLS. Routine application of this technique should be considered to offer targeted monitoring and timely initiation of cardioprotective treatment.



Clin Res Cardiol: 25 Sep 2019; epub ahead of print
Coutinho Cruz M, Moura Branco L, Portugal G, Galrinho A, ... Luz R, Cruz Ferreira R
Clin Res Cardiol: 25 Sep 2019; epub ahead of print | PMID: 31559482
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Impact:
Abstract

Effects of renal denervation on 24-h heart rate and heart rate variability in resistant hypertension.

Ukena C, Seidel T, Rizas K, Scarsi D, ... Mahfoud F, Böhm M
Background
Catheter-based renal sympathetic denervation (RDN) can reduce sympathetic activity and blood pressure (BP) in patients with hypertension. The present study aimed at investigating the effects of RDN on heart rate (HR), number of premature captions, and heart rate variability (HRV).
Methods
A total of 105 patients (67% male, age 63.5 ± 10 years) with resistant hypertension (BP 169 ± 22/89 ± 14 mmHg) underwent bilateral RDN using a radiofrequency catheter (Symplicity Flex, Medtronic). 24-h Holter monitoring was performed at baseline and after 6 months. Besides HR profile, the number of premature atrial (PAC) and ventricular captions (PVC), time and frequency domain-based HRV were analyzed. Data are presented as mean ± standard deviation or median (interquartile range).
Results
Office systolic and diastolic BP were reduced after RDN by 21.8 ± 25.2 mmHg and 8 ± 18.7 mmHg (p < 0.001 for both), respectively. Twenty-eight (27%) patients had a reduction of < 10 mmHg in systolic BP. At baseline, mean 24-h HR was 65.7 ± 9.9 bpm. The prevalence of PAC [median 1.2 (0.3-6.2)] and PVC [median 1.2 (0.1-13.9)] was low and values of HRV were within normal limits and not different between responders and non-responders. After 6 months, patients with a baseline HR > 72 min had a significant reduction in HR by 2.3 ± 7.1 bpm. Parameters of HRV did not significantly change during follow-up. In patients with ≥ 6 PAC per hour at baseline, a significant median reduction of - 12.4 (- 37.4 to - 2.3) PAC after 6 months was documented (p = 0.002), which occurred independently from BP effects. The number of PVC was not significantly altered after RDN.
Conclusion
In patients with resistant hypertension and elevated HR or high burden of PACs, RDN was associated with a reduction of HR and number of PAC. Parameters of HRV were not changed after RDN nor were predictive of response to RDN.



Clin Res Cardiol: 24 Sep 2019; epub ahead of print
Ukena C, Seidel T, Rizas K, Scarsi D, ... Mahfoud F, Böhm M
Clin Res Cardiol: 24 Sep 2019; epub ahead of print | PMID: 31555986
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Impact:
Abstract

The SAPPHIRE criteria, history of myocardial infarction and diabetes predict adverse outcomes following carotid endarterectomy similar to stenting.

Macharzina RR, Müller C, Vogt M, Messé SR, ... Neumann FJ, Zeller T
Aims
Identifying factors associated with worse outcome following carotid endarterectomy (CEA) is important to improve prevention of major adverse cardiovascular and cerebrovascular events (MACCE), yet rarely used for registries. We intended to identify predictors of MACCE following CEA as recently analysed for stenting.
Methods and results
Patients undergoing CEA at 2 centers over 13 years were entered into a database. Baseline clinical characteristics, procedural factors and a panel of clinical and lesion-related high-risk features (SHR) and exclusion criteria (SE), empirically compiled for stratification in the SAPPHIRE trial, were differentially analysed using Cox regressions. The analysis included 748 operations; 262 (35%) asymptomatic, 208 (28%) with previous strokes, and 278 (37%) with transient ischemic attacks (TIA). The overall 30-day MACCE rate was 6.7%, 5.0% in asymptomatic and 7.6% in symptomatic patients. Previous MI (HR 2.045, p = 0.022), diabetes (HR 2.111, p = 0.011) and symptomatic patients (HR 2.045, p = 0.044) were independently associated with MACCE. SE patients (n = 81) had a MACCE rate of 13.6%; the MACCE rate of the remainder dropped to 5.8% (4.7% in asymptomatic and 6.5% in symptomatic patients). Hazard ratio for SHR patients was 2.069 (CI 1.087-3.941) and 2.389 for SE (CI 1.223-4.666), each compared to all patients with lower risk and adjusted for symptomatic status. Among SHR and SE criteria NYHA 3-4, contralateral occlusions and intraluminal thrombus were significant determinants and MI < 4 weeks before CEA showed a strong trend (p = 0.05).
Conclusion
Patients identified by SHR and SE criteria, prior MI and diabetes warrant increased attention to prevent MACCE following CEA.



Clin Res Cardiol: 24 Sep 2019; epub ahead of print
Macharzina RR, Müller C, Vogt M, Messé SR, ... Neumann FJ, Zeller T
Clin Res Cardiol: 24 Sep 2019; epub ahead of print | PMID: 31555985
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Impact:
Abstract

A comparison of procedural success rate and long-term clinical outcomes between in-stent restenosis chronic total occlusion and de novo chronic total occlusion using multicenter registry data.

Lee SH, Cho JY, Kim JS, Lee HJ, ... Lim DS, Yu CW
Background
There have been little data about outcomes of percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) chronic total occlusion (CTO) in the drug eluting stent (DES) era. This study aimed to compare the procedural success rate and long-term clinical outcomes of ISR CTO and de novo CTO.
Methods and results
Patients who underwent PCI for ISR CTO (n = 164) versus de novo CTO (n = 1208) were enrolled from three centers in Korea between January 2008 and December 2014. Among a total of ISR CTO, a proportion of DES ISR CTO was 79.3% (n = 130). The primary outcome was major adverse cardiac events (MACEs); a composite of all-cause death, non-fatal myocardial infarction (MI), or target lesion revascularization (TLR). Following propensity score-matching (1:3), the ISR CTO group (n = 156) had a higher success rate (84.6% vs. 76.0%, p = 0.035), mainly driven by high success rate of PCI for DES ISR CTO (88.6%), but showed a higher incidence of MACEs [hazard ratio (HR): 2.06; 95% confidence interval (CI) 1.37-3.09; p < 0.001], mainly driven by higher prevalence of MI [HR: 9.71; 95% CI 2.06-45.81; p = 0.004] and TLR [HR: 3.04; 95% CI 1.59-5.81; p = 0.001], during 5 years of follow-up after successful revascularization, as compared to the de novo CTO group (n = 408).
Conclusion
The procedural success rate was higher in the ISR CTO than the de novo CTO, especially in DES ISR CTO. However, irrespective of successful revascularization, the long-term clinical outcomes for the ISR CTO were significantly worse than those for the de novo CTO, in terms of MI and TLR.



Clin Res Cardiol: 23 Sep 2019; epub ahead of print
Lee SH, Cho JY, Kim JS, Lee HJ, ... Lim DS, Yu CW
Clin Res Cardiol: 23 Sep 2019; epub ahead of print | PMID: 31552494
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Impact:
Abstract

Association between anemia and hematological indices with mortality among cardiac intensive care unit patients.

Rayes HA, Vallabhajosyula S, Barsness GW, Anavekar NS, ... Kashani KB, Jentzer JC
Background
Anemia and elevated red cell distribution width (RDW) or mean corpuscular volume (MCV) are associated with an adverse prognosis in patients with cardiovascular disease and critical illness. Limited data exist regarding these associations in unselected cardiac intensive care unit (CICU) patients.
Methods
Retrospective cohort study of CICU patients between January 1, 2007, and December 31, 2015, with a hemoglobin (Hb) level measured at admission. Multivariable regression was performed to determine predictors of hospital mortality, and Kaplan-Meier analysis was used to determine post-discharge survival.
Results
We included 9644 patients with a mean age of 67.5 ± 15.1 years, including 3604 (37.4%) females. The median (IQR) values of Hb, MCV and RDW were 12.2 g/dL (10.6, 13.7), 90.7 fL (87.3, 94.2) fL, and 14.1% (13.3, 15.8), respectively. Anemia (admission Hb < 12 g/dL) was present in 4434 (46%) patients. A total of 845 (8.8%) patients died in the hospital. Patients with anemia had higher hospital mortality (11.3% vs. 6.6%, unadjusted OR 1.82, 95% CI 1.58-2.10, p < 0.001). After multivariable regression, admission Hb and MCV were not significantly associated with hospital mortality (both p > 0.1), while admission RDW (adjusted OR 1.12 per 1%, 95% CI 1.07-1.18, p < 0.001) was significantly associated with hospital mortality. Hospital survivors with lower Hb, higher MCV, or higher RDW had lower post-discharge survival.
Conclusion
Elevated RDW on admission was independently associated with higher hospital mortality in CICU patients. These data emphasize the importance of hematologic abnormalities for mortality risk stratification in CICU populations.



Clin Res Cardiol: 17 Sep 2019; epub ahead of print
Rayes HA, Vallabhajosyula S, Barsness GW, Anavekar NS, ... Kashani KB, Jentzer JC
Clin Res Cardiol: 17 Sep 2019; epub ahead of print | PMID: 31535171
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Impact:
Abstract

ARNIs: balancing \"the good and the bad\" of neuroendocrine response to HF.

Ferrari R, Cardoso J, Fonseca MC, Aguiar C, ... Rapezzi C,
Background
A new class of drugs-angiotensin receptor, neprylisin inhibitors, ARNI-has shown to be prognostic superior in HFrEF to the sole inhibition of the renin-angiotensin axes with enalapril. The ultimate mechanism of action of ARNIs is unknown.
Aim
We have considered that ARNI exerts a positive modulation of the neuroendocrine balance, with enhancement of the physiological diuresis and dilatation due to neprylisin inhibition by sacubitril. This represents a shift in HF medical therapy always directed to counteract (with inhibitors of the renin-angiotensin system, beta blockers or inhibitors of aldosterone) the so-called \"bad\" neuroendocrine response. Development of ARNI, on the contrary, has led to consider the neuroendocrine response to HFrEF from a different angle, which is to say that the activation is not always deleterious, but it could also be beneficial. This concept is highlighted by the enhancement of the activity of atrial natriuretic peptide, induced by sacubitril/valsartan in the PARADIGM trial, and found as proof from early studies on untreated patients with constrictive pericarditis. The possibility that sacubitril inhibition of neprylisin acts by enhancing substance P and gene-related calcitonin peptide is also considered, as well as the negative effect of neprylisin inhibition.
Conclusions
The beneficial effects of ARNI are related, in part at least, to a positive modulation of the neuroendocrine response to the disease, resulting in an increase of physiological diuresis and dilatation.



Clin Res Cardiol: 16 Sep 2019; epub ahead of print
Ferrari R, Cardoso J, Fonseca MC, Aguiar C, ... Rapezzi C,
Clin Res Cardiol: 16 Sep 2019; epub ahead of print | PMID: 31531687
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Impact:
Abstract

Are atrial high rate episodes (AHREs) a precursor to atrial fibrillation?

Khan AA, Boriani G, Lip GYH

Atrial high rate episodes (AHREs), also termed, subclinical atrial tachyarrhythmias or subclinical atrial fibrillation (AF) are an important cardiovascular condition. Advancement in implantable cardiac devices such as pacemakers or internal cardiac defibrillators has enabled the continuous assessment of atrial tachyarrhythmias in patients with an atrial lead. Patients with device-detected AHREs are at an elevated risk of stroke and may have unmet anticoagulation needs. While the benefits of oral anticoagulation for stroke prevention in patients with clinical AF are well recognised, it is not known whether the same risk-benefit ratio exists for anticoagulation therapy in patients with AHREs. The occurrence and significance of AHRE are increasingly acknowledged but these events are still not often acted upon in patients presenting with stroke and TIA. Additionally, patients with AHRE show a significant risk for major adverse cardiovascular events (MACE) including acute heart failure, myocardial infarction, cardiovascular hospitalisation, ventricular tachycardia/fibrillation, which is dependent on AHRE burden. In this review, we present an overview of this relatively new entity, its associated thromboembolic risk and its management implications.



Clin Res Cardiol: 13 Sep 2019; epub ahead of print
Khan AA, Boriani G, Lip GYH
Clin Res Cardiol: 13 Sep 2019; epub ahead of print | PMID: 31522249
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Abstract

Expert consensus document on the assessment of the severity of aortic valve stenosis by echocardiography to provide diagnostic conclusiveness by standardized verifiable documentation.

Hagendorff A, Knebel F, Helfen A, Knierim J, ... Fehske W, Ewen S

According to recent recommendations on echocardiographic assessment of aortic valve stenosis direct measurement of transvalvular peak jet velocity, calculation of transvalvular mean gradient from the velocities using the Bernoulli equation and calculation of the effective aortic valve area by continuity equation are the appropriate primary key instruments for grading severity of aortic valve stenosis. It is obvious that no gold standard can be declared for grading the severity of aortic stenosis. Thus, conclusions of the exclusive evaluation of aortic stenosis by Doppler echocardiography seem to be questionable due to the susceptibility to errors caused by methodological limitations, mathematical simplifications and inappropriate documentation. The present paper will address practical issues of echocardiographic documentation to satisfy the needs to analyze different scenarios of aortic stenosis due to various flow conditions and pressure gradients. Transesophageal and multidimensional echocardiography should be implemented for reliable measurement of geometric aortic valve area and of cardiac dimensions at an early stage of the diagnostic procedure to avoid misinterpretation due to inconsistent results.



Clin Res Cardiol: 02 Sep 2019; epub ahead of print
Hagendorff A, Knebel F, Helfen A, Knierim J, ... Fehske W, Ewen S
Clin Res Cardiol: 02 Sep 2019; epub ahead of print | PMID: 31482241
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Abstract

Catheter ablation in highly symptomatic Brugada patients: a Dutch case series.

Haanschoten DM, Elvan A, Postema PG, Smit JJJ, ... Crijns HJGM, Wilde AAM
Aims
In the past few years, promising results were described in targeting the arrhythmogenic substrate of the epicardial right ventricular outflow tract (RVOT) region in patients with Brugada syndrome (BrS). In this report, we describe our experience with endo- and epicardial substrate mapping and ablation in a series of highly symptomatic BrS patients.
Methods
This case series consists of seven patients with clinical BrS diagnosis who underwent catheter ablation in two Dutch hospitals (Isala hospital Zwolle; and Amsterdam University Medical Centre, location AMC, Amsterdam) and Hamad Heart Hospital in Qatar between 2013 and 2017. All patients had an ICD and recurrent ventricular arrhythmia (VA) episodes. All patients underwent endo-and epicardial mapping of the RVOT region. Elimination of all abnormal potentials and disappearance of BrS ECG pattern during the ablation procedure was the aimed endpoint.
Results
The study group consisted of seven patients with mean age 45.6 ± 16.9 years. Five patients had SCN5A mutations. One patient was excluded from analysis, since ablation could not be performed due to a very large low-voltage area and was later diagnosed with arrhythmogenic right ventricular cardiomyopathy, associated with an SCN5A mutation. One patient underwent both endo- and epicardial ablation to eliminate VA. During a mean follow-up of 3.6 ± 1.5 years, 5/6 patients remained VA free with two patients continuing quinidine.
Conclusion
In patients with BrS and drug-refractory VA, ablation of the arrhythmogenic substrate in the RVOT region was associated with excellent long-term VA-free survival. The majority of these highly symptomatic BrS patients had an SCN5A mutation and also low-voltage areas epicardially.



Clin Res Cardiol: 01 Sep 2019; epub ahead of print
Haanschoten DM, Elvan A, Postema PG, Smit JJJ, ... Crijns HJGM, Wilde AAM
Clin Res Cardiol: 01 Sep 2019; epub ahead of print | PMID: 31478073
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Abstract

Transcatheter aortic valve implantation in patients with bicuspid aortic valve stenosis utilizing the next-generation fully retrievable and repositionable valve system: mid-term results from a prospective multicentre registry.

Kochman J, Zbroński K, Kołtowski Ł, Parma R, ... Lesiak M, Opolski G
Background
The aim of this study was to evaluate the outcomes of transcatheter aortic valve implantation (TAVI) in bicuspid aortic valve (BiAV) stenosis using a mechanically expanded Lotus™ device. The prior experience with first-generation devices showed disappointing results mainly due to increased prevalence of aortic regurgitation (AR) that exceeded those observed in tricuspid stenosis.
Methods and results
We collected baseline, in-hospital, 30-day and 2-year follow-up data from a prospective, multicentre registry of patients with BiAV undergoing TAVI using Lotus™ valve. Safety and efficacy endpoints were assessed according to VARC-2 criteria. The study group comprised 24 patients. The mean age was 73.5 years and the mean EuroSCORE 2 was 4.35 ± 2.56%. MDCT analysis revealed Type 1 BiAV in 75% of patients. The mean gradient decreased from 60.1 ± 18.3 to 15 ± 6.4 mm Hg, the AVA increased from 0.6 ± 0.19 to 1.7 ± 0.21 cm. One in-hospital death was observed secondary to aortic perforation. There was no severe AR and the rate of moderate AR equalled 9% at 30 days (n = 2). Device success was achieved in 83% and the 30-day safety endpoint was 17%. In the 2-year follow-up, the overall mortality was 12.5% and the 2-year composite clinical efficacy endpoint was met in 25% of the patients (n = 6) Conclusions: The TAVI in selected BiAV patients using the Lotus™ is feasible and characterized by encouraging valve performance and mid-term clinical outcomes.



Clin Res Cardiol: 01 Sep 2019; epub ahead of print
Kochman J, Zbroński K, Kołtowski Ł, Parma R, ... Lesiak M, Opolski G
Clin Res Cardiol: 01 Sep 2019; epub ahead of print | PMID: 31478072
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Abstract

Cardiac surgery 2018 reviewed.

Doenst T, Bargenda S, Kirov H, Moschovas A, ... Diab M, Faerber G

For the year 2018, more than 22,000 published references can be found in PubMed when entering the search term \"cardiac surgery\". As in the last 4 years, this review focusses on conventional cardiac surgery publications which provide important and interesting information especially relevant for non-surgical colleagues. Interventional techniques have been considered if they were published in the context of classic surgical techniques. We have again reviewed the fields of coronary revascularization and valve surgery and briefly touched on aortic surgery and surgery for terminal heart failure. For revascularization of complex coronary artery disease, bypass grafting was reconfirmed as gold standard and computer-tomographic angiography established equipoise for decision-making with classic angiography. For aortic valve treatment, some new longer-term outcomes from TAVI vs. SAVR trials confirmed equipoise of both treatments for high and medium risk. New information was provided for INR-management of mechanical aortic valves as well as long-term experiences for alternatives to mechanical valves (i.e., Ross and the relatively new Ozaki procedure). In the mitral and tricuspid field, prevalence data illustrate a significant amount of under-treatment for mitral and tricuspid valve regurgitation and evidence for life prolonging-effects of surgery. Finally, elongation of the ascending aorta was identified as new risk factor for aortic dissection and 2 years outcome of the newest generation of left ventricular assist devices demonstrate impressive improvements in outcome. While this article attempts to summarize the most pertinent publications, it does not expect to be complete and cannot be free of individual interpretation. As in recent years, it provides a condensed summary that is intended to give the reader \"solid ground\" for up-to-date decision-making in cardiac surgery and a stimulus for in-depth reading.



Clin Res Cardiol: 30 Aug 2019; 108:974-989
Doenst T, Bargenda S, Kirov H, Moschovas A, ... Diab M, Faerber G
Clin Res Cardiol: 30 Aug 2019; 108:974-989 | PMID: 30929035
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Abstract

Non-cardiac comorbidities and mortality in patients with heart failure with reduced vs. preserved ejection fraction: a study using the Swedish Heart Failure Registry.

Ergatoudes C, Schaufelberger M, Andersson B, Pivodic A, Dahlström U, Fu M
Background
Heart failure (HF) and non-cardiac comorbidities often coexist and are known to have an adverse effect on outcome. However, the prevalence and prognostic impact of non-cardiac comorbidities in patients with HF with reduced ejection fraction (HFrEF) vs. those with preserved (HFpEF) remain inadequately studied.
Methods and results
We used data from the Swedish Heart Failure Registry from 2000 to 2012. HFrEF was defined as EF < 50% and HFpEF as EF ≥ 50%. Of 31 344 patients available for analysis, 79.3% (n = 24 856) had HFrEF and 20.7% (n = 6 488) HFpEF. The outcome was all-cause mortality. We examined the association between ten non-cardiac comorbidities and mortality and its interaction with EF using adjusted hazard ratio (HR). Stroke, anemia, gout and cancer had a similar impact on mortality in both phenotypes, whereas diabetes (HR 1.57, 95% confidence interval [CI] [1.50-1.65] vs. HR 1.39 95% CI [1.27-1.51], p = 0.0002), renal failure (HR 1.65, 95% CI [1.57-1.73] vs. HR 1.44, 95% CI [1.32-1.57], p = 0.003) and liver disease (HR 2.13, 95% CI [1.83-2.47] vs. HR 1.42, 95% CI [1.09-1.85] p = 0.02) had a higher impact in the HFrEF patients. Moreover, pulmonary disease (HR 1.46, 95% CI [1.40-1.53] vs. HR 1.66 95% CI [1.54-1.80], p = 0.007) was more prominent in the HFpEF patients. Sleep apnea was not associated with worse prognosis in either group. No significant variation was found in the impact over the 12-year study period.
Conclusions
Non-cardiac comorbidities contribute significantly but differently to mortality, both in HFrEF and HFpEF. No significant variation was found in the impact over the 12-year study period. These results emphasize the importance of including the management of comorbidities as a part of a standardized heart failure care in both HF phenotypes.



Clin Res Cardiol: 30 Aug 2019; 108:1025-1033
Ergatoudes C, Schaufelberger M, Andersson B, Pivodic A, Dahlström U, Fu M
Clin Res Cardiol: 30 Aug 2019; 108:1025-1033 | PMID: 30788622
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Abstract

Qualitative and quantitative neointimal characterization by optical coherence tomography in patients presenting with in-stent restenosis.

Xhepa E, Byrne RA, Rivero F, Rroku A, ... Alfonso F, Kastrati A
Aims
To describe optical coherence tomography (OCT) findings in patients with in-stent restenosis (ISR) and determine predictors of neointimal patterns and neoatherosclerosis.
Methods and results
Patients undergoing OCT prior to PCI for ISR in three European centres were included. Analyses were performed in a core laboratory. Qualitative and quantitative [gray-scale signal intensity (GSI)] neointima analyses were performed on a per quadrant basis. A total of 107 patients were included. Predominantly homogeneous lesions included 4.5% (0.0-14.3) non-homogeneous quadrants, while predominantly non-homogeneous ones included 28.1% (20.3-37.5) homogeneous quadrants. Mean GSI values differed significantly between homogeneous [108.4 (92.5-123.6)], non-homogeneous [79.9 (61.2-95.9)], and neoatherosclerosis [88.3 (72.8-104.9)] quadrants (p < 0.001 for all comparisons). Stent underexpansion was observed in 48.5% and 61.1% of lesions, respectively (p = 0.225). Female sex and maximal neointimal thickness independently correlate with a non-homogeneous pattern, while angiographic pattern and diabetes mellitus inversely correlate with such pattern. Time from index stenting procedure was the only independent predictor of neoatherosclerosis.
Conclusions
Different neointimal patterns coexist in a significant proportion of ISR lesions. GSI values differ significantly between neointimal categories. Neoatherosclerosis is a time-dependent phenomenon, displaying different time courses in DES compared to BMS, with earlier appearance in the former group. Stent underexpansion is a frequent finding in patients with ISR.



Clin Res Cardiol: 30 Aug 2019; 108:1059-1068
Xhepa E, Byrne RA, Rivero F, Rroku A, ... Alfonso F, Kastrati A
Clin Res Cardiol: 30 Aug 2019; 108:1059-1068 | PMID: 30783752
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Abstract

Doxorubicin treatments induce significant changes on the cardiac autonomic nervous system in childhood acute lymphoblastic leukemia long-term survivors.

Caru M, Corbin D, Périé D, Lemay V, ... Sinnett D, Curnier D
Aims
Acute lymphoblastic leukemia (ALL) is one of the leading malignancies in children worldwide. The cardiotoxicity of anti-cancer treatments leads to a dysfunction of the cardiac autonomic nervous system. Protection strategies, with dexrazoxane treatments, were used to counter these adverse effects. The aim of this study was to investigate the effects of the treatments on the cardiac autonomic nervous system.
Methods and results
A total of 203 cALL survivors were included in our analyses and were classified into 3 categories based on the prognostic risk group: standard risk, high risk with and without dexrazoxane. A 24-h Holter monitoring was performed to study the cardiac autonomic nervous system. The frequency domain heart rate variability (HRV) was used to validate the cardiac autonomic nervous system modifications. Other analyses were performed using linear HRV indexes in the time domain and non-linear indexes. A frequency domain HRV parameters analysis revealed significant differences on an overall time-period of 24 h. A repeated measures ANOVA indicated a group-effect for the low frequency (p = 0.029), high frequency (p = 0.03) and LF/HF ratio (p = 0.029). Significant differences in the time domain and in the non-linear power spectral density HRV parameters were also observed.
Conclusion
Anti-cancer treatments induced significant changes in the cardiac autonomic nervous system. The HRV was sensitive enough to detect cardiac autonomic nervous system alterations depending on the cALL risk category. Protection strategies (i.e., dexrazoxane treatments), which were used to counter the adverse effects of doxorubicin, could prevent changes observed in the cardiac autonomic nervous system.



Clin Res Cardiol: 30 Aug 2019; 108:1000-1008
Caru M, Corbin D, Périé D, Lemay V, ... Sinnett D, Curnier D
Clin Res Cardiol: 30 Aug 2019; 108:1000-1008 | PMID: 30778669
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Abstract

Relation of lowering door-to-balloon time and mortality in ST segment elevation myocardial infarction patients undergoing percutaneous coronary intervention.

Zahler D, Lee-Rozenfeld K, Ravid D, Rozenbaum Z, ... Keren G, Shacham Y
Background
Current guidelines for the treatment of ST-segment elevation myocardial infarction (STEMI) recommend a door-to-balloon time (DBT) of ≤ 90 min for patients undergoing primary percutaneous coronary intervention (PCI). We aimed to investigate the possible impact of further reduction in DBT intervals beyond the 90 min cutoff on short and long-term outcomes among STEMI patients undergoing primary PCI.
Methods
We retrospectively studied 889 STEMI patients (median age 61 years, 83% men) who underwent successful primary PCI and had a DBT of ≤ 90 min. Patients were stratified according to DBT into 2 groups: < 60 min and 60-90 min. Patients records were assessed for the occurrence of in-hospital complications, 30-day and 1-year mortality.
Results
Patients having DBT < 60 min (n = 608, 68%) were more likely to present earlier, in daytime and weekdays, and had better post-procedural left ventricular ejection fraction and lower 30-day mortality (3% vs. 6%, p = 0.03). Mortality over 1-year was significantly lower among patients having DBT < 60 compared to DBT of 60-90 min (4.6% vs. 9.6%, p = 0.004). In a binary logistic regression model DBT < 60 min was associated with 51% risk reduction for 1-year mortality (OR 0.49, 95% CI 0.25-0.93, p = 0.03).
Conclusions
Among STEMI patients undergoing primary PCI within 90 min of admission DBT < 60 min was independently associated with better 1-year mortality.



Clin Res Cardiol: 30 Aug 2019; 108:1053-1058
Zahler D, Lee-Rozenfeld K, Ravid D, Rozenbaum Z, ... Keren G, Shacham Y
Clin Res Cardiol: 30 Aug 2019; 108:1053-1058 | PMID: 30778668
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Abstract

Uptake in antithrombotic treatment and its association with stroke incidence in atrial fibrillation: insights from a large German claims database.

Hohnloser SH, Basic E, Nabauer M
Background
Underuse of oral anticoagulation (OAC) for stroke prevention in atrial fibrillation (AF) results in thousands of preventable strokes in Germany each year. This study aimed to assess changes in antithrombotic therapy in AF patients after increased use of direct oral anticoagulants (DOACs) in Germany and to evaluate whether the adoption of DOAC therapy was associated with changes in AF-related stroke and bleeding over time.
Methods
Analyses were carried out on a large claims-based dataset of 4 million health-insured Germans. The study population consisted of 601,261 prevalent AF patients between 2011 and 2016 who were assigned to one of the following four treatment groups: DOAC, VKA, antiplatelets or no antithrombotic treatment. Treatment patterns were descriptively analysed and represented by cohort and CHADS-VASc score. Clinical outcomes before and after the adoption of DOAC therapy were assessed using Poisson regression models.
Results
Use of OAC increased from 42 to 61% between 2011 and 2016, mainly due to more frequent prescription of DOACs. However, some underuse of OAC therapy remained even in high risk AF patients. In parallel with the increased prescription rate of OAC, there was an overall 24% incidence reduction in stroke between 2011 and 2016 which was mainly driven by reductions in ischemic strokes. Over the same time period the risk for major bleeding remained unchanged.
Conclusion
Between 2011 and 2016, the use of guideline-conform antithrombotic therapy in Germany has significantly increased. This was associated with a significant decline in strokes without an increased incidence of bleeding complications.



Clin Res Cardiol: 30 Aug 2019; 108:1042-1052
Hohnloser SH, Basic E, Nabauer M
Clin Res Cardiol: 30 Aug 2019; 108:1042-1052 | PMID: 30771066
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Abstract

Atrial high rate episodes in patients with cardiac implantable electronic devices: implications for clinical outcomes.

Miyazawa K, Pastori D, Li YG, Székely O, ... Boriani G, Lip GYH
Background
Atrial high rate episodes (AHREs) detected by cardiac implantable electronic devices (CIEDs) are associated with an increased risk of stroke. However, the impact of AHRE on improving stroke risk stratification scheme remains uncertain.
Objective
The purpose of this study was to assess the impact of AHRE on prognosis in relation with cardiovascular events and risk stratification.
Methods
A total of 856 consecutive patients who had dual-chamber CIEDs implanted were retrospectively analyzed. To detect AHREs, they were monitored for 6 months after CIEDs\' implantation and were followed for a mean of 4.0 years for clinical outcomes such as thromboembolism or death.
Results
Overall, 125 (14.6%) of patients developed AHREs within the first 6 months (median age 72.0 years, 39.3% female). Patients with AHREs had a high rate of thromboembolism (2.6%/year) and mortality (3.0%/year). On multivariate analysis, AHRE was significantly associated with increased risk of thromboembolism [hazard ratio (HR) 3.40; 95% confidence interval (CI) 1.38-8.37, P = 0.01] and death (HR 3.47; 95% CI 1.51-7.95; P < 0.01). The predictive abilities of the CHADS and CHADS-VASc scores were modest, with no significant improvements by adding AHRE to those scores. However, the integrated discrimination improvement and net reclassification improvement showed that the addition of AHRE to the CHADS and CHADS-VASc scores statistically improved their predictive ability for the composite outcome.
Conclusions
AHRE was an independent factor associated with increased risk of clinical outcomes. The addition of AHRE to the clinical risk scores significantly improved discrimination for thromboembolism or death.



Clin Res Cardiol: 30 Aug 2019; 108:1034-1041
Miyazawa K, Pastori D, Li YG, Székely O, ... Boriani G, Lip GYH
Clin Res Cardiol: 30 Aug 2019; 108:1034-1041 | PMID: 30759274
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Abstract

Impact of single-visit American versus European office blood pressure measurement procedure on individual blood pressure classification: a cross-sectional study.

Vischer AS, Socrates T, Winterhalder C, Eckstein J, Mayr M, Burkard T
Objectives
Recently, ACC/AHA and ESC/ESH guidelines defined different office blood pressure measurement (OBPM) procedures and ranges. We aimed to describe the effect of the different methods to calculate OBPM on BP classification.
Methods and results
Four standardised OBPM were performed in 802 patients within a single visit. BP values were calculated (EUR-/US-BPM) and categorised (EUR-/US-Ranges) according to ACC/AHA and ESC/ESH guidelines. Comparing the BPM procedures, the mean absolute difference of systolic and diastolic BP was 4 (SD ± 5) and 3 (SD ± 3) and a difference ≥ 5 mmHg was found in 35% and 16%, respectively. There was an increase of grade 1/2 arterial hypertension of 87% and 120% comparing BP values categorised according to US-Ranges with EUR-Ranges after applying EUR- or US-BPM to all (p < 0.0001), of 25% and 6% comparing BP values calculated according to US-BPM with EUR-BPM applying EUR- or US-Ranges to all (p = 0.006 and p = 0.17), and of 134% comparing US-Ranges/US-BPM with EUR-Ranges/EUR-BPM (p < 0.0001), respectively. Overall, 16% were reclassified to higher categories when applying US-BPM, and 42-45% of patients classified as \"high normal\" applying EUR-BPM procedures were reclassified when applying US-BPM procedure, 76-77% of them to \"hypertensive\" categories.
Conclusion
Besides the effect of the redefinition of BP categories by ACC/AHA, the calculation method of US-BPM compared to EUR-BPM leads to a further relevant increase of patients classified as \"hypertensive\". In addition to the definition of uniform outcome-oriented target BP values, there is an urgent need for a universal definition of an OBPM procedure as prerequisite for proper BP classification and patient management.



Clin Res Cardiol: 30 Aug 2019; 108:990-999
Vischer AS, Socrates T, Winterhalder C, Eckstein J, Mayr M, Burkard T
Clin Res Cardiol: 30 Aug 2019; 108:990-999 | PMID: 30725172
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Abstract

Haemodynamic prosthetic valve performance in patients with early leaflet thrombosis after transcatheter aortic valve implantation.

Hein M, Minners J, Jander N, Breitbart P, ... Neumann FJ, Ruile P
Aims
We sought to evaluate haemodynamic prosthetic valve performance in patients with early leaflet thrombosis (LT) after transcatheter aortic valve implantation (TAVI).
Method and results
In this retrospective observational study, 59 patients with LT underwent clinical and echocardiographic follow-up. During a median follow-up of 383 days 41 patients received antiplatelet therapy (APT-group) and 18 patients oral anticoagulation due to atrial fibrillation (AC-group). The mean pressure gradient (MPG) at baseline did not differ between groups (P = 0.875). During follow-up, MPG increased from 11.0 (9.0; 14.5) to 13.0 mmHg (10.0; 18.0)_ in the APT-group (P = 0.010) but remained unchanged in the AC-group (P = 0.297) resulting in a significantly higher MPG in patients on antiplatelet therapy (P = 0.024). Similarly, change of MPG per year was significantly higher in the APT-group [1.4 (- 0.9; 7.0) vs. - 0.6 (- 2.5; 1.1), P = 0.014]. Seven (17.1%) patients in the APT-group and two(11.1%) patients in the AC-group developed MPGs of at least 20 mmHg (P = 0.558). Three patients (7.3%) in the APT- and none in the AC-group developed symptoms of obstructive thrombosis (P = 0.239). In our adjusted analysis, only lack of anticoagulation was significantly associated with change in gradients during follow-up (P = 0.012).
Conclusions
In patients with LT, antiplatelet-, but not anticoagulant therapy, was associated with significant increases in MPG, which may lead to symptomatic obstructive valve thrombosis.



Clin Res Cardiol: 30 Aug 2019; 108:1017-1024
Hein M, Minners J, Jander N, Breitbart P, ... Neumann FJ, Ruile P
Clin Res Cardiol: 30 Aug 2019; 108:1017-1024 | PMID: 30725171
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Abstract

Left atrial anterior line ablation using ablation index and inter-lesion distance measurement.

Santoro F, Metzner A, Brunetti ND, Heeger CH, ... Ouyang F, Rillig A
Background
Ablation index (AI) is a novel ablation quality marker that incorporates contact force (CF), time and power in a weighted formula to provide accurate information about lesion formation during catheter ablation. This index has been evaluated for pulmonary vein isolation (PVI) but has not been systematically used for other left atrial (LA) procedures so far. The aim of this study is to evaluate the feasibility and efficacy of this index for LA anterior line (AL) ablation (LAALA).
Methods
30 consecutive patients with persistent atrial fibrillation or LA macro-reentrant tachycardia and large low-voltage area at the left atrial anterior wall were evaluated and divided into 2 groups: group 1 (15 pts) LAALA guided by CF; group 2 (15 pts) LAALA guided by AI target (500) and inter-lesion distance ≤ 6 mm.
Results
In group 2, shorter ablation time (12.5 ± 3.8 vs 17 ± 7 min, p = 0.049), overall RF application time (7.9 ± 1.4 vs 10.8 ± 3.2 min. p = 0.01) and less radiofrequency (RF) applications (14.5 ± 2.3 vs 20.5 ± 6.1 p = 0.01) were necessary to achieve AL bi-directional block. Acute reconnection of the AL was documented in three patients (20%) of group 1 and in no patient of group 2 (20% vs 0% p = 0.22). At site of reconnection, an inter-lesion distance > 6 mm was always found. There was no difference in terms of CF and power between group 2 and group 1. AI was statistically different between group 2 and group 1 (AI = 511 ± 77 vs 451 ± 111; p = 0.004).
Conclusion
AI-guided LAALA in this study was feasible and featured by shorter ablation time, shorter overall RF application time and a reduced number of RF applications to achieve AL bidirectional block.



Clin Res Cardiol: 30 Aug 2019; 108:1009-1016
Santoro F, Metzner A, Brunetti ND, Heeger CH, ... Ouyang F, Rillig A
Clin Res Cardiol: 30 Aug 2019; 108:1009-1016 | PMID: 30712147
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Impact:
Abstract

Mitral valve leaflet repair with the new PASCAL system: early real-world data from a German multicentre experience.

Kriechbaum SD, Boeder NF, Gaede L, Arnold M, ... Hamm CW, Nef HM
Aims
To examine the clinical experience and practical use of the PASCAL transcatheter valve repair system (Edwards Lifesciences, Irvine, CA, USA) and to report some of the first clinical results.
Methods and results
A total of 18 consecutive patients with severe, symptomatic mitral regurgitation (MR) were included in this German multicentre registry. All patients underwent clinical, echocardiographic, and laboratory assessment prior to the PASCAL procedure and before hospital discharge. MR was classified as functional in 6 patients, degenerative in 2, and combined in 10. All except one received a single PASCAL implant. The preprocedural severe MR present in all patients was reduced: grade 0 in 4 (22.2%), grade I in 11 (61.1%), grade II in 3 (16.7%). The v-wave was significantly reduced from 31.7 ± 9.5 to 18 ± 7.7 mmHg (p < 0.001). Independent leaflet capture, performed in 4 (22.2%) of the patients, wide clasps, and the 10-mm central spacer are features of the PASCAL device to optimize mitral leaflet repair. There were no periprocedural complications.
Conclusion
PASCAL is a safe and effective mitral valve repair device for the treatment of severe MR. Device-specific features allow valve repair tailored to the individual anatomy of the underlying mitral pathology in each patient.



Clin Res Cardiol: 25 Aug 2019; epub ahead of print
Kriechbaum SD, Boeder NF, Gaede L, Arnold M, ... Hamm CW, Nef HM
Clin Res Cardiol: 25 Aug 2019; epub ahead of print | PMID: 31451915
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Impact:
Abstract

Interdisciplinary consensus on indications for transfemoral transcatheter aortic valve implantation (TF-TAVI) : Joint Consensus Document of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte e.V. (ALKK) and cooperating Cardiac Surgery Departments.

von Scheidt W, Welz A, Pauschinger M, Fischlein T, ... Stumpf C, Hoffmeister HM

Indications for TF-TAVI (transfemoral transcatheter aortic valve implantation) are rapidly changing according to increasing evidence from randomized controlled trials. Present trials document the non-inferiority or even superiority of TF-TAVI in intermediate-risk patients (STS-Score 4-8%) as well as in low-risk patients (STS-Score < 4%). However, risk scores exhibit limitations and, as a single criterion, are unable to establish an appropriate indication of TF-TAVI vs transapical TAVI vs SAVR (surgical aortic valve replacement). The ESC (European Society of Cardiology)/EACTS (European Association for Cardio-Thoracic Surgery) guidelines 2017 and the German DGK (Deutsche Gesellschaft für Kardiologie)/DGTHG (Deutsche Gesellschaft für Thorax-, Herz- und Gefäßchirurgie) commentary 2018 offer a framework for the selection of the best therapeutic method, but the individual decision is left to the discretion of the heart teams. An interdisciplinary TAVI consensus group of interventional cardiologists of the ALKK (Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte e.V.) and cardiac surgeons has developed a detailed consensus on the indications for TF-TAVI to provide an up-to-date, evidence-based, comprehensive decision matrix for daily practice. The matrix of indication criteria includes age, risk scores, contraindications against SAVR (e.g., porcelain aorta), cardiovascular criteria pro TAVI, additional criteria pro TAVI (e.g., frailty, comorbidities, organ dysfunction), contraindications against TAVI (e.g., endocarditis) and cardiovascular criteria pro SAVR (e.g., bicuspid valve anatomy). This interdisciplinary consensus may provide orientation to heart teams for individual TAVI-indication decisions. Future adaptations according to evolving medical evidence are to be expected. Interdisciplinary consensus on indications for transfemoral transcatheter aortic valve implantation (TF-TAVI).



Clin Res Cardiol: 12 Aug 2019; epub ahead of print
von Scheidt W, Welz A, Pauschinger M, Fischlein T, ... Stumpf C, Hoffmeister HM
Clin Res Cardiol: 12 Aug 2019; epub ahead of print | PMID: 31410547
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Abstract

Adenosine stress perfusion cardiac magnetic resonance imaging in patients undergoing intracoronary bone marrow cell transfer after ST-elevation myocardial infarction: the BOOST-2 perfusion substudy.

Seitz A, Wollert KC, Meyer GP, Müller-Ehmsen J, ... Mahrholdt H, Greulich S
Aims
In the placebo-controlled, double-blind BOne marrOw transfer to enhance ST-elevation infarct regeneration (BOOST) 2 trial, intracoronary autologous bone marrow cell (BMC) transfer did not improve recovery of left ventricular ejection fraction (LVEF) at 6 months in patients with ST-elevation myocardial infarction (STEMI) and moderately reduced LVEF. Regional myocardial perfusion as determined by adenosine stress perfusion cardiac magnetic resonance imaging (S-CMR) may be more sensitive than global LVEF in detecting BMC treatment effects. Here, we sought to evaluate (i) the changes of myocardial perfusion in the infarct area over time (ii) the effects of BMC therapy on infarct perfusion, and (iii) the relation of infarct perfusion to LVEF recovery at 6 months.
Methods and results
In 51 patients from BOOST-2 (placebo, n = 10; BMC, n = 41), S-CMR was performed 5.1 ± 2.9 days after PCI (before placebo/BMC treatment) and after 6 months. Infarct perfusion improved from baseline to 6 months in the overall patient cohort as reflected by the semi-quantitative parameters, perfusion defect-infarct size ratio (change from 0.54 ± 0.20 to 0.43 ± 0.22; P = 0.006) and perfusion defect-upslope ratio (0.54 ± 0.23 to 0.68 ± 0.22; P < 0.001), irrespective of randomised treatment. Perfusion defect-upslope ratio at baseline correlated with LVEF recovery (r = 0.62; P < 0.001) after 6 months, with a threshold of 0.54 providing the best sensitivity (79%) and specificity (74%) (area under the curve, 0.79; 95% confidence interval, 0.67-0.92).
Conclusion
Infarct perfusion improves from baseline to 6 months and predicts LVEF recovery in STEMI patients undergoing early PCI. Intracoronary BMC therapy did not enhance infarct perfusion in the BOOST-2 trial.



Clin Res Cardiol: 09 Aug 2019; epub ahead of print
Seitz A, Wollert KC, Meyer GP, Müller-Ehmsen J, ... Mahrholdt H, Greulich S
Clin Res Cardiol: 09 Aug 2019; epub ahead of print | PMID: 31401672
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Abstract

Long-term effects of baroreflex activation therapy: 2-year follow-up data of the BAT Neo system.

Wallbach M, Born E, Kämpfer D, Lüders S, ... Wachter R, Koziolek MJ
Objective
Baroreflex activation therapy (BAT) reduces office blood pressure (BP) in patients with resistant hypertension (HTN). Whereas sustained effects from the BAT Rheos device have already been reported, no long-term data on 24-h ambulatory BP (ABP) are currently available for the unilateral BAT Neo device.
Methods
Patients treated with the BAT neo device for resistant hypertension were prospectively included into this observational study. Office and ABP measurements were performed before BAT implantation as well as 6, 12 and 24 months after initiation of BAT.
Results
A total of 60 patients with resistant HTN (office BP 172 ± 25/90 ± 17 mmHg, 24-h ABP 150 ± 16/80 ± 12 mmHg, median of antihypertensive drugs 7 (IQR 6-8)) were included. After 24 months, there was a significant reduction of - 25 ± 33/- 9 ± 18 mmHg (n = 50, both p < 0.01) in office BP and - 8 ± 23/- 5 ± 13 mmHg (n = 46, both p = 0.02) in 24-h ABP, while the number of antihypertensive medications was reduced to a median of 5 (4-6) drugs (p < 0.01). Patients with isolated systolic HTN (ISH) experienced a BP-lowering effect in office BP, but not in ABPM at month 24. Using unadjusted BP values, BAT seems to be more effective in combined hypertension (CH) than in ISH. After adjustment for baseline BP values, there was no significant difference in BP reduction between ISH and CH patients. Ambulatory SBP at baseline was the only independent correlate of BP response at month 24.
Conclusion
BAT reduced office BP and improved relevant parameters of ABP, which is associated with a high cardiovascular risk, in patients with resistant HTN, whereas, after adjustment for baseline BP, BP reduction was not different in patients with CH compared with patients with ISH. However, randomized controlled trials are needed to confirm the effects of BAT on 24-h ABP.



Clin Res Cardiol: 05 Aug 2019; epub ahead of print
Wallbach M, Born E, Kämpfer D, Lüders S, ... Wachter R, Koziolek MJ
Clin Res Cardiol: 05 Aug 2019; epub ahead of print | PMID: 31388741
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Abstract

Passive leg-lifting in heart failure patients predicts exercise-induced rise in left ventricular filling pressures.

Tossavainen E, Wikström G, Henein MY, Lundqvist M, Wiklund U, Lindqvist P
Aim
The aim of this study was to assess PCWP with passive leg-lifting (PLL) and exercise, in two groups of patients presenting with normal left ventricular ejection fraction (LVEF); one group with elevated NT-proBNP (eBNP), and one with normal NT-proBNP (nBNP) plasma concentration.
Methods and results
Fifty-one patients with eBNP (NT-proBNP ≥ 125 ng/l) and LVEF > 50%, were investigated and compared with 34 patients with nBNP (NT-proBNP < 125 ng/l) and LVEF > 50%. Both groups underwent right heart catheterization (RHC) at rest, PLL and exercise. From RHC, mean pulmonary arterial pressure (mPAP), cardiac output (CO), and PCWP were measured. All nBNP patients had PCWP < 15 mmHg at rest, and a PCWP of < 25 mmHg with PLL and during exercise. Patients with eBNP had higher (p < 0.01) resting mPAP, PCWP, and mPAP/CO. These values increased with exercise; however, CO increased less in comparison with nBNP patients (p = 0.001). 20% of patients with eBNP had a PCWP > 15 mmHg at rest, this percentage increased to 47% with PLL and 41% had a PCWP > 25 mmHg during exercise. Of those with PCWP > 25 mmHg during exercise, 91% had a PCWP > 15 mmHg with PLL. A PCWP > 15 mmHg on PLL had a 91% sensitivity and 92% specificity in predicting exercise-induced PCWP of > 25 mmHg.
Conclusion
In patients presenting with eBNP, PLL can predict which patients will develop elevated PCWP with exercise. These findings highlight the role of stress assessment.



Clin Res Cardiol: 30 Jul 2019; epub ahead of print
Tossavainen E, Wikström G, Henein MY, Lundqvist M, Wiklund U, Lindqvist P
Clin Res Cardiol: 30 Jul 2019; epub ahead of print | PMID: 31368000
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Abstract

Implantable cardioverter defibrillators in patients with electrical heart disease and hypertrophic cardiomyopathy: data from the German device registry.

Frommeyer G, Reinke F, Andresen D, Kleemann T, ... Senges J, Eckardt L
Background
Implantable cardioverter- defibrillator (ICD) therapy is established for the prevention of sudden cardiac death (SCD) in different entities. However, data from large patient cohorts with electrical heart disease are rare. Therefore, we investigated these patients as well as patients with hypertrophic cardiomyopathy by analyzing registry data from a multi-center \'real-life\' registry.
Methods
The German Device Registry (DEVICE) is a nationwide, prospective registry with one-year follow-up investigating 5450 patients receiving device implantations in 50 German centers. The present analysis of DEVICE focussed on patients with electrical heart disease or HCM who received an ICD for primary or secondary prevention.
Results
174 patients with HCM and 112 patients with electrical heart disease (long-QT syndrome, Brugada syndrome and arrhythmogenic right ventricular cardiomyopathy) were compared with 5164 other ICD patients. Median follow-up was 17.0 months. Patients in the control group were significantly older. Of note, overall mortality after 1 year was 1.8% in HCM patients, 6.6% in patients with electrical heart disease and 7.3% in the control group. Patients in the control group presented significantly more severe comorbidities. In contrast to HCM patients and the control group where primary prevention was the major indication for ICD implantation, 77.5% of patients with electrical heart disease received an ICD for secondary prevention. The number of surgical revisions was higher in patients with electrical heart disease.
Conclusion
Data from the present registry display a surprisingly high mortality in patients with electrical heart disease equivalent to the control group. A high proportion of patients who received an ICD for secondary prevention may be regarded as a major determinant for these results, while severe comorbidities such as diabetes, hypertension, and renal failure are major determinants for mortality in the control cohort.



Clin Res Cardiol: 30 Jul 2019; epub ahead of print
Frommeyer G, Reinke F, Andresen D, Kleemann T, ... Senges J, Eckardt L
Clin Res Cardiol: 30 Jul 2019; epub ahead of print | PMID: 31367999
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Abstract

Role of pregnancy hormones and hormonal interaction on the maternal cardiovascular system: a literature review.

Kodogo V, Azibani F, Sliwa K

Hormones have a vital duty in the conservation of physiological cardiovascular function during pregnancy. Alterations in oestrogen, progesterone and prolactin levels are associated with changes in the cardiovascular system to support the growing foetus and counteract pregnancy stresses. Pregnancy hormones are, however, also linked to numerous pathophysiological outcomes on the cardiovascular system. The expression and effects of the three main pregnancy hormones (oestrogen, prolactin and progesterone) vary depending on the gestation period. However, the reaction of a target cell also depends on the abundance of hormone receptors and impacts put forth by other hormones. Hormonal interaction may be synergistic, antagonistic or permissive. It is crucial to explore the cross talk of pregnancy hormones during gestation, as this may have a greater impact on the overall changes to the cardiovascular system.



Clin Res Cardiol: 30 Jul 2019; 108:831-846
Kodogo V, Azibani F, Sliwa K
Clin Res Cardiol: 30 Jul 2019; 108:831-846 | PMID: 30806769
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Abstract

Risk of cardiac arrhythmias after electrical accident: a single-center study of 480 patients.

Pilecky D, Vamos M, Bogyi P, Muk B, ... Zacher G, Zima E
Objective
Patients with electrical injury are considered to be at high risk of cardiac arrhythmias. Due to the small number of studies, there is no widely accepted guideline regarding the risk assessment and management of arrhythmic complications after electrical accident (EA). Our retrospective observational study was designed to determine the prevalence of ECG abnormalities and cardiac arrhythmias after EA, to evaluate the predictive value of cardiac biomarkers for this condition and to assess in-hospital and 30-day mortality.
Methods
Consecutive patients presenting after EA at the emergency department of our institution between 2011 and 2016 were involved in the current analysis. ECG abnormalities and arrhythmias were analyzed at admission and during ECG monitoring. Levels of cardiac troponin I, CK and CK-MB were also collected. In-hospital and 30-day mortality data were obtained from hospital records and from the national insurance database.
Results
Of the 480 patients included, 184 (38.3%) had suffered a workplace accident. The majority of patients (96.2%) had incurred a low-voltage injury (< 1000 V). One hundred and four (21.7%) patients had a transthoracic electrical injury while 13 (2.7%) patients reported loss of consciousness. The most frequent ECG disorders at admission were sinus bradycardia (< 60 bpm, n = 50, 10.4%) and sinus tachycardia (> 100 bpm, n = 21, 4.4%). Other detected arrhythmias were as follows: newly diagnosed atrial fibrillation (n = 1); frequent multifocal atrial premature complexes (n = 1); sinus arrest with atrial escape rhythm (n = 2); ventricular fibrillation terminated out of hospital (n = 1); ventricular bigeminy (n = 1); and repetitive nonsustained ventricular tachycardia (n = 1). ECG monitoring was performed in 182 (37.9%) patients for 12.7 ± 7.1 h at the ED. Except for one case with regular supraventricular tachycardia terminated via vagal maneuver and one other case with paroxysmal atrial fibrillation, no clinically relevant arrhythmias were detected during the ECG monitoring. Cardiac troponin I was measured in 354 (73.8%) cases at 4.6 ± 4.3 h after the EA and was significantly elevated only in one resuscitated patient. CK elevation was frequent, but CK-MB was under 5% in all patients. Both in-hospital and 30-day mortality were 0%.
Conclusions
Most of cardiac arrhythmias in patients presenting after EA can be diagnosed by an ECG on admission, thus routine ECG monitoring appears to be unnecessary. In our patient cohort cardiac troponin I and CK-MB were not useful in risk assessment after EA. Late-onset malignant arrhythmias were not observed.



Clin Res Cardiol: 30 Jul 2019; 108:901-908
Pilecky D, Vamos M, Bogyi P, Muk B, ... Zacher G, Zima E
Clin Res Cardiol: 30 Jul 2019; 108:901-908 | PMID: 30771067
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Abstract

Non-invasive evaluation of the relationship between electrical and structural cardiac abnormalities in patients with myotonic dystrophy type 1.

Chmielewski L, Bietenbeck M, Patrascu A, Rösch S, ... Yilmaz A, Florian AR
Background
Cardiac involvement in myotonic dystrophy type 1 (MD1) includes conduction disease, arrhythmias, and left-ventricular (LV) systolic dysfunction leading to an increased sudden cardiac death risk. An understanding of the interplay between electrical and structural myocardial changes could improve the prediction of adverse cardiac events. We aimed to explore the relationship between signs of cardiomyopathy by conventional and advanced cardiovascular magnetic resonance (CMR), and electrical abnormalities in MD1.
Methods
Fifty-seven MD1 patients (43 ± 13 years, 46% male) and 15 matched controls (41 ± 7 years, 53% male) underwent CMR including cine-imaging with feature-tracking strain analysis, late gadolinium enhancement (LGE), and native/post-contrast T1-mapping with extracellular volume calculation. Standard 12-lead and long-term ECG monitoring were performed as screening for rhythm and/or conduction abnormalities.
Results
Abnormal ECGs were recorded in 40% of MD1; a pathologic CMR was found in 44%: 21% had an impaired LV-EF and 32% showed non-ischemic LGE. When looking at MD1 patients with available long-term ECG monitoring (n = 39), those with atrial fibrillation (Afib)/flutter(Afl) episodes had lower LV-EF (52 ± 7 vs. 60 ± 5%, p = 0.002), lower global longitudinal strain (- 17 ± 3 vs. - 20 ± 3%, p = 0.034), a trend to lower left atrial emptying fraction (LA-EF) (44 ± 14 vs. 55 ± 8%, p = 0.08), and higher prevalence of LGE (88% vs. 23%, p = 0.001) with an intramural (75% vs. 23%, p = 0.01) and septal (63% vs. 13%, p = 0.009) pattern. In a model including LV-EF (OR 0.8, 95% CI 0.7-1.0, p = NS) and LGE presence (OR 14.8, 95% CI 1.4-159.0, p = 0.026), only LGE was independently associated with the occurrence of Afib/Afl episodes.
Conclusion
Myocardial abnormalities depicted by non-ischemic LGE-CMR were the only independent predictor for the occurrence of Afib/Afl on ECG monitoring, previously shown to predict adverse cardiac events in MD1.



Clin Res Cardiol: 30 Jul 2019; 108:857-867
Chmielewski L, Bietenbeck M, Patrascu A, Rösch S, ... Yilmaz A, Florian AR
Clin Res Cardiol: 30 Jul 2019; 108:857-867 | PMID: 30767060
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Abstract

Proenkephalin and prognosis in heart failure with preserved ejection fraction: a GREAT network study.

Kanagala P, Squire IB, Jones DJL, Cao TH, ... Ng LL,
Background
Proenkephalin (PENK), a stable endogenous opioid biomarker related to renal function, has prognostic utility in acute and chronic heart failure. We investigated the prognostic utility of PENK in heart failure with preserved ejection fraction (HFpEF), and its relationship to renal function, Body Mass Index (BMI), and imaging measures of diastolic dysfunction.
Methods
In this multicentre study, PENK was measured in 522 HFpEF patients (ejection fraction > 50%, 253 male, mean age 76.13 ± 10.73 years) and compared to 47 age and sex-matched controls. The primary endpoint was 2-years composite of all-cause mortality and/or heart failure rehospitalisation (HF). A subset (n = 163) received detailed imaging studies.
Results
PENK levels were raised in HFpEF (median [interquartile range] 88.9 [62.1-132.0]) compared to normal controls (56.3 [47.9-70.5]). PENK was correlated to urea, eGFR, Body Mass Index and E/e\' (r 0.635, - 0.741, - 0.275, 0.476, respectively, p < 0.0005). During 2 years follow-up 144 patients died and 220 had death/HF endpoints. Multivariable Cox regression models showed PENK independently predicted 2 year death/HF [hazard ratio (for 1 SD increment of log-transformed biomarker) HR 1.45 [95% CI 1.12-1.88, p = 0.005]], even after adjustment for troponin (HR 1.59 [1.14-2.20, p = 0.006]), and Body Mass Index (HR 1.63 [1.13-2.33, p = 0.009]). PENK showed no interaction with ejection fraction status for prediction of poor outcomes. Net reclassification analyses showed PENK significantly improved classification of death/HF outcomes for multivariable models containing natriuretic peptide, troponin and Body Mass Index (p < 0.05 for all).
Conclusions
In HFpEF, PENK levels are related to BMI, and measures of diastolic dysfunction and are prognostic for all-cause mortality and heart failure rehospitalisation.



Clin Res Cardiol: 30 Jul 2019; 108:940-949
Kanagala P, Squire IB, Jones DJL, Cao TH, ... Ng LL,
Clin Res Cardiol: 30 Jul 2019; 108:940-949 | PMID: 30767059
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Abstract

Graded murine wire-induced aortic valve stenosis model mimics human functional and morphological disease phenotype.

Niepmann ST, Steffen E, Zietzer A, Adam M, ... Zimmer S, Quast C

Aortic valve stenosis (AS) is the most common valve disease requiring therapeutic intervention. Even though the incidence of AS has been continuously rising and AS is associated with significant morbidity and mortality, to date, no medical treatments have been identified that can modify disease progression. This unmet medical need is likely attributed to an incomplete understanding of the molecular mechanism driving disease development. To investigate the pathophysiology leading to AS, reliable and reproducible animal models that mimic human pathophysiology are needed. We have tested and expanded the protocols of a wire-injury induced AS mouse model. For this model, coronary wires were used to apply shear stress to the aortic valve cusps with increasing intensity. These protocols allowed distinction of mild, moderate and severe wire-injury. Upon moderate or severe injury, AS developed with a significant increase in aortic valve peak blood flow velocity. While moderate injury promoted solitary AS, severe-injury induced mixed aortic valve disease with concomitant mild to moderate aortic regurgitation. The changes in aortic valve function were reflected by dilation and hypertrophy of the left ventricle, as well as a decreased left ventricular ejection fraction. Histological analysis revealed the classic hallmarks of human disease with aortic valve thickening, increased macrophage infiltration, fibrosis and calcification. This new mouse model of AS promotes functional and morphological changes similar to moderate and severe human AS. It can be used to investigate the pathomechanisms contributing to AS development and to test novel therapeutic strategies.



Clin Res Cardiol: 30 Jul 2019; 108:847-856
Niepmann ST, Steffen E, Zietzer A, Adam M, ... Zimmer S, Quast C
Clin Res Cardiol: 30 Jul 2019; 108:847-856 | PMID: 30767058
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Abstract

Prognostic impact of recurrences of ventricular tachyarrhythmias and appropriate ICD therapies in a high-risk ICD population.

Schupp T, Akin I, Reiser L, Bollow A, ... Borggrefe M, Behnes M
Purpose
The study sought to evaluate the prognostic impact of recurrences of ventricular tachyarrhythmias in consecutive ICD recipients with ventricular tachyarrhythmias on admission.
Methods
All consecutive patients surviving at least one episode of ventricular tachyarrhythmias from 2002 to 2016 and discharged with an ICD (pre-existing ICD or ICD implantation at index hospitalization) were included. The primary endpoint was all-cause mortality according to the presence or absence of recurrences of ventricular tachyarrhythmias at 5 years. Secondary endpoints comprised the impact of different types of recurrences, appropriate ICD therapies, as well as predictors of recurrences and appropriate ICD therapies. Kaplan-Meier, multivariable Cox regression and propensity score matching analyses were applied.
Results
A total of 592 consecutive ICD recipients was included (44% with recurrences of ventricular tachyarrhythmias and 56% without). Recurrences of ventricular tachyarrhythmias were associated with increased all-cause mortality at 5 years (HR = 1.498; 95% CI = 1.052-2.132; p = 0.025). Worst survival was observed in patients with sustained VT or VF as first recurrences compared to non-sustained VT, as well as in patients with cumulative recurrences of non-sustained or sustained VT plus VF, whereas mortality was not affected by the number of recurrences of ventricular tachyarrhythmias (> 4 vs. ≤ 4). Moreover, appropriate ICD therapies were associated with increased all-cause mortality (HR = 1.874; 95% CI = 1.318-2.666; p = 0.001), mainly attributed to secondary preventive ICDs. Finally, atrial fibrillation, LVEF < 35% and non-ischemic cardiomyopathy were identified as predictors of recurrences of ventricular tachyarrhythmias and appropriate ICD therapies.
Conclusions
Recurrences of ventricular tachyarrhythmias and recurrent appropriate ICD therapies are associated with increased long-term all-cause mortality in consecutive ICD recipients. Non-ischemic cardiomyopathy, AF and LVEF < 35% revealed to be significant predictors of both endpoints.



Clin Res Cardiol: 30 Jul 2019; 108:878-891
Schupp T, Akin I, Reiser L, Bollow A, ... Borggrefe M, Behnes M
Clin Res Cardiol: 30 Jul 2019; 108:878-891 | PMID: 30756152
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Impact:
Abstract

Transcatheter aortic valve replacement for pure aortic valve regurgitation: \"on-label\" versus \"off-label\" use of TAVR devices.

Wernly B, Eder S, Navarese EP, Kretzschmar D, ... Falk V, Lauten A
Introduction
Transcatheter aortic valve replacement (TAVR) has become the mainstay of treatment for aortic stenosis in patients with high surgical risk. Pure aortic regurgitation (PAR) is considered a relative contraindication for TAVR; however, TAVR is increasingly performed in PAR patients with unfavorable risk profile. Herein, we aim to summarize available data on TAVR for PAR with special emphasis on \"on-label\" versus \"off-label\" TAVR devices.
Methods and results
Pubmed was searched for studies of patients undergoing TAVR for PAR. Primary outcome was 30 day-mortality. Pooled estimated event rates were calculated. Twelve studies including a total of 640 patients were identified until December 2017. Among these, 208 (33%) patients were treated with devices with CE-mark approval for PAR (\"on-label\"; JenaValve and J valve). Overall, the procedural success rate was 89.9% (95% CI 81.1-96.1%; I 80%). Major bleeding was reported in 6.4% (95% CI 2.9-10.8%; I 48%). All-cause mortality at 30 days was 10.4% (95% CI 7.1-14.2%; I 20%). Stroke occurred in 2.2% (95% CI 0.9-3.9%; I 0%). A permanent pacemaker was required in 10.7% (95% CI 7.3-14.6%; I 23%). At 30 days after TAVR, ≥ moderate AR post-interventional was observed in 11.5% (95% CI 2.9-23.6%; I 90%). In the \"on-label\"-group, success rate was 93.0% (95% CI 85.9-98.1%; I 52%). 30-day-mortality was 9.1% (95% CI 3.7-16.0%; I 36%). More than trace AR was present in 2.8% (95% CI 0.1-7.6%; I 0%). Compared to first-generation devices, second-generation devices were associated with significantly lower 30-day-mortality (r = - 0.10; p = 0.02), and significantly higher procedural success rates (r = 0.28; p < 0.001). Compared to other second-generation devices, the use of J valve or JenaValve was not associated with altered mortality (r = 0.04; p = 0.50), rates of > trace residual AR (r = - 0.05; p = 0.65) but with a significantly higher procedural success (r = 0.15; p = 0.042).
Conclusion
Based on this summary of available observational data TAVR for PAR is feasible and safe in patients deemed inoperable. First-generation TAVR devices are associated with inferior outcome and should be avoided. The \"on-label\" use of PAR-certified TAVR devices is associated with a significantly higher procedural success rate and might be favorable compared to other second-generation devices.



Clin Res Cardiol: 30 Jul 2019; 108:921-930
Wernly B, Eder S, Navarese EP, Kretzschmar D, ... Falk V, Lauten A
Clin Res Cardiol: 30 Jul 2019; 108:921-930 | PMID: 30737532
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Abstract

Hemodynamics of paradoxical severe aortic stenosis: insight from a pressure-volume loop analysis.

Gotzmann M, Hauptmann S, Hogeweg M, Choudhury DS, ... Bergbauer M, Mügge A
Background
Controversy exists about the pathophysiology of different hemodynamic subgroups of AS. In particular, the mechanism of the paradoxical low-flow, low-gradient (PLFLG) AS with preserved ejection fraction (EF) is unclear.
Methods
A total of 41 patients with severe, symptomatic AS were divided into the following 4 subgroups based on the echocardiographically determined hemodynamics: (1) normal-flow, high-gradient (NFHG) AS; (2) low-flow, high-gradient AS; (3) paradoxical low-flow, low-gradient (PLFLG) AS with preserved EF and (4) low-flow, low-gradient (LFLG) AS with reduced EF. As part of the comprehensive invasive examinations, the analyses of the PV loops were performed with the IntraCardiac Analyzer (CD-Leycom, The Netherlands).
Results
PLFLG was characterized by small left ventricular volumes as well as a decreased cardiac index, a decreased systolic contractility and a lower stroke work, than the conventional NFHG AS. Alterations in effective arterial elastance (2.36 ± 0.67 mmHg/ml in NFHG versus 3.01 ± 0.79 mmHg/ml in PLFLG, p = 0.036) and end-systolic elastance (3.72 ± 1.84 mmHg/ml in NFHG versus 5.53 ± 2.3 mmHg/ml in PLFLG, p = 0.040) indicated impaired vascular function and increased chamber stiffness.
Conclusions
The present study suggests that the hemodynamics of PLFLG AS can be explained by two mechanisms: (1) stiffness of the small left ventricle with reduced contractility, and (2) increased afterload due to the impairment of vascular function. Both mechanisms have similarities to those of heart failure with preserved EF. This type of remodeling may explain the poor prognosis of PLFLG AS.



Clin Res Cardiol: 30 Jul 2019; 108:931-939
Gotzmann M, Hauptmann S, Hogeweg M, Choudhury DS, ... Bergbauer M, Mügge A
Clin Res Cardiol: 30 Jul 2019; 108:931-939 | PMID: 30737530
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Impact:
Abstract

Impacts of non-recovery of trastuzumab-induced cardiomyopathy on clinical outcomes in patients with breast cancer.

Yoon HJ, Kim KH, Kim HY, Park H, ... Cho JG, Park JC
Objectives
The impacts of non-recovery of trastuzumab-induced left ventricular dysfunction (LVD) on clinical outcomes in breast cancer have been poorly studied. We investigated the predictors of LV-functional non-recovery and its impacts on clinical outcomes in breast cancer patients with trastuzumab-induced LVD.
Methods and results
A total of 243 patients with trastuzumab-induced LVD were divided into the recovered LVD group (n = 195) and non-recovered LVD group (n = 48). Major adverse clinical events (MACEs) including death, symptomatic heart failure (HF), and HF hospitalization (HHF) were compared. Hemoglobin and albumin levels were significantly lower in non-recovered LVD than in recovered LVD group. Non-recovered LVD group showed significantly larger LV end-diastolic and systolic dimension, higher pulmonary artery systolic pressure, lower LV ejection fraction (EF), and decreased global longitudinal strain than in recovered LVD group. Decreased LVEF, enlarged LV size, pulmonary hypertension, and anemia were independent predictors of LV-functional non-recovery. During 45.9 ± 23.5 months of follow-up, MACEs were developed in 32 patients: 15 deaths, 28 symptomatic HF, and 22 HHF. In Kaplan-Meier survival analysis, MACE free survival was significantly lower in non-recovered LVD group than in recovered LVD group (log rank p = 0.002).
Conclusion
LV-functional non-recovery was not uncommon in breast cancer patients with trastuzumab-induced cardiomyopathy, and non-recovered LVD was significantly associated with MACEs. Decreased LVEF, enlarged LV size, pulmonary hypertension, and anemia were independent predictors of LV-functional non-recovery. Careful monitoring for MACEs and intensive medical management should be considered in trastuzumab-induced cardiomyopathy with these characteristics.



Clin Res Cardiol: 30 Jul 2019; 108:892-900
Yoon HJ, Kim KH, Kim HY, Park H, ... Cho JG, Park JC
Clin Res Cardiol: 30 Jul 2019; 108:892-900 | PMID: 30737527
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Impact:
Abstract

Polyhedral erythrocytes in intracoronary thrombus and their association with reperfusion in myocardial infarction.

Zalewski J, Lewicki L, Krawczyk K, Zabczyk M, ... Nessler J, Undas A
Objective
The tightly packed arrays of polyhedral erythrocytes, polyhedrocytes, formed during thrombus contraction, have been detected in some intracoronary thrombi (ICT) obtained from patients with ST-segment elevation myocardial infarction (STEMI). We sought to investigate determinants of polyhedrocyte content in ICT and its association with reperfusion in STEMI.
Methods
We assessed the composition of ICT obtained during thrombectomy within 12 h since the symptom onset in 110 STEMI patients, following 300 mg of aspirin (n = 110) and 600 mg of clopidogrel (n = 75). The predominance of fibrin, erythrocytes, polyhedrocytes or platelets was evaluated using scanning electron microscopy.
Results
Polyhedrocytes were found in 34 (30.9%) ICT, in which they covered 20-50% (median 38.8%) fields of view. Patients with polyhedrocytes in ICT had lower median minimal reference infarct-related artery (IRA) diameter by 20% (p < 0.0001) and area by 31% (p < 0.0001) versus those without polyhedrocytes. Time of ischemia showed association with the polyhedrocyte content (r = 0.26, p = 0.007). By multivariate analysis, minimal IRA diameter (β = - 0.50, p < 0.0001) and ischemia time (β = 0.20, p = 0.035) independently affected polyhedrocyte content in ICT (R = 0.45, p < 0.0001). Patients with ischemia time of > 3 h and polyhedrocytes present in ICT had more frequently TIMI-2/3 flow after thrombus aspiration (96% vs. 67%, p = 0.02) and final TIMI-2/3 myocardial perfusion grade (92% vs. 57%, p = 0.044) versus those without polyhedrocytes.
Conclusions
Our findings indicate that the presence of polyhedrocytes in ICT, observed in one-third of STEMI patients, is associated with smaller minimal IRA diameter, prolonged ischemia and their formation in late presenters is associated with more effective thrombus aspiration and better myocardial reperfusion.



Clin Res Cardiol: 30 Jul 2019; 108:950-962
Zalewski J, Lewicki L, Krawczyk K, Zabczyk M, ... Nessler J, Undas A
Clin Res Cardiol: 30 Jul 2019; 108:950-962 | PMID: 30710262
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Impact:
Abstract

Stress T1-mapping cardiovascular magnetic resonance imaging and inducible myocardial ischemia.

Bohnen S, Prüßner L, Vettorazzi E, Radunski UK, ... Lund GK, Muellerleile K
Background
Alterations in native myocardial T1 under vasodilation stress (\"T1 reactivity\") were recently proposed as a non-contrast cardiovascular magnetic resonance (CMR) method to detect myocardial ischemia. This study evaluated the performance of a segmental, truly non-contrast stress T1 mapping CMR approach to detect inducible ischemia.
Methods and results
One-hundred patients with suspected/known coronary artery disease underwent CMR at 3.0 or 1.5 T. T1 mapping was performed using the 5s(3s)3s-modified look-locker inversion-recovery (MOLLI) sequence at rest and under regadenoson stress. We defined T1 reactivity as the change in native T1 from rest to stress (1) in the 16-segment AHA model independent from perfusion images and (2) in focal regions of interest that were copied from perfusion images to T1 maps. We compared T1 reactivity between segments/regions with inducible ischemia, scar, and remote myocardium for both approaches. Segmental T1 reactivity was significantly lower in segments including inducible ischemia [- 1.15 (95% CI, - 2.16 to - 0.14)%] compared to remote segments [2.49 (95% CI, 1.87 to 3.11)%; p < 0.001]. Focal T1 reactivity was also significantly lower [- 2.65 (95% CI, - 3.84 to - 1.46)%] in regions with stress-perfusion defects compared to remote regions [4.72 (95% CI, 3.90 to 5.54)%; p < 0.001]. However, the performance of segmental T1 reactivity to depict inducible ischemia was significantly inferior compared to the focal approach (AUCs 0.68 versus 0.85; p < 0.0001).
Conclusions
Myocardium with inducible ischemia is characterized by the absence of significant T1 reactivity, but a clinically applicable approach for truly non-contrast stress T1 mapping remains to be determined.



Clin Res Cardiol: 30 Jul 2019; 108:909-920
Bohnen S, Prüßner L, Vettorazzi E, Radunski UK, ... Lund GK, Muellerleile K
Clin Res Cardiol: 30 Jul 2019; 108:909-920 | PMID: 30701297
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Impact:
Abstract

Efficacy of an implantable cardioverter-defibrillator in patients with diabetes and heart failure and reduced ejection fraction.

Rørth R, Dewan P, Kristensen SL, Jhund PS, ... Køber L, McMurray JJV
Background
The effect of implantable cardioverter-defibrillator (ICD) therapy in patients with heart failure with reduced ejection fraction (HFrEF) and diabetes is not fully elucidated.
Methods
We examined the effect of ICD therapy on sudden cardiac death, cardiovascular death and all-cause mortality, according to diabetes status at baseline in the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT). The outcomes were analyzed by use of cumulative incidence curves and Cox regressions models.
Results
Of the 1676 patients randomized to an ICD or placebo, 540 (32%) had diabetes at baseline. Patients with diabetes were slightly older (61 vs 58 years) and were more often in NYHA class III (37% vs 28%). ICD therapy did not reduce the risk of sudden cardiac death in HFrEF patients with diabetes (HR = 0.85; 95% CI 0.52-1.40); even though these patients had a higher risk of sudden cardiac death compared to patients without diabetes (HR = 1.73 95% CI 1.22-2.47). By contrast, ICD therapy did reduce sudden cardiac death in HFrEF patients without diabetes (HR = 0.26; 95% CI 0.15-0.46); P=0.002. The findings for cardiovascular and all-cause death were similar.
Conclusion
ICD therapy did not reduce the risk of sudden cardiac death (or, as a consequence, all-cause death) in HFrEF patients with diabetes. Conversely, an ICD reduced the risk of sudden death in patients without diabetes, irrespective of etiology.



Clin Res Cardiol: 30 Jul 2019; 108:868-877
Rørth R, Dewan P, Kristensen SL, Jhund PS, ... Køber L, McMurray JJV
Clin Res Cardiol: 30 Jul 2019; 108:868-877 | PMID: 30689020
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Impact:
Abstract

Management and outcomes of patients with unstable angina with undetectable, normal, or intermediate hsTnT levels.

Giannitsis E, Biener M, Hund H, Mueller-Hennessen M, ... Katus HA, Stoyanov KM
Background
Patients with unstable angina (UA) are regarded to be at low risk for future coronary events. Guidelines discourage routine coronary angiography and recommend early discharge after individualized risk stratification. The relative value of clinical risk indicators as compared to cardiac troponin (cTn) alone is unsettled in the era of high-sensitivity cardiac troponin (hsTn) assays. We aimed to investigate the clinical characteristics, therapies, and outcomes of UA patients with different hsTnT concentrations.
Methods
During 12 months, 2525 patients were enrolled. UA was defined as unstable symptoms and either undetectable (< 5 ng/L), normal (5-14 ng/L) or stable elevated hsTnT (15-51 ng/L). Follow-up for 1-year mortality was available in 98.7%.
Results
A total of 280 patients (11.1%) received a diagnosis of UA. Mortality rates at 12 months were 0%, 1.9% and 6.9% in presence of undetectable, normal and stable elevated hsTnT. Elevated hsTnT > 99th percentile but not unstable symptoms carried an independent 3.25-fold (1.78-5.93) higher risk for all-cause death after adjustment for other clinical risk indicators or the GRACE score. Utilization of guideline-recommended therapies was high albeit lower than for non-ST-elevation myocardial infarction (NSTEMI). Significantly fewer patients with UA received dual antiplatelet therapy (DAPT, odds ratio (OR) 0.51 [95% CI 0.44-0.59], P < 0.0001), coronary angiography (CA, OR 0.79, [95% CI 0.74-0.87], P < 0.0001), and percutaneous coronary intervention (PCI, OR 0.50, [95% CI 0.40-0.61], P < 0.0001), compared to NSTEMI. However, prevalence of significant obstructive coronary artery disease requiring PCI was 31.8%, even in patients with undetectable hsTnT, indicating the need for stress testing.
Conclusions
The current dichotomization of patients into UA and NSTEMI is no longer appropriate. Additional risk stratification seems warranted including the presence and magnitude of hsTn concentration and additional risk indicators. Clinical Trials Identifier: NCT03111862.



Clin Res Cardiol: 18 Jul 2019; epub ahead of print
Giannitsis E, Biener M, Hund H, Mueller-Hennessen M, ... Katus HA, Stoyanov KM
Clin Res Cardiol: 18 Jul 2019; epub ahead of print | PMID: 31325044
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Impact:
Abstract

Residual inflammatory risk in coronary heart disease: incidence of elevated high-sensitive CRP in a real-world cohort.

Peikert A, Kaier K, Merz J, Manhart L, ... Zirlik A, Stachon P
Background
Inflammation drives atherosclerosis and its complications. Anti-inflammatory therapy with interleukin 1 beta (IL-1β) antibody reduces cardiovascular events in patients with elevated high-sensitive C-reactive protein (hsCRP). This study aims to identify the share of patients with coronary heart disease (CHD) and residual inflammation who may benefit from anti-inflammatory therapy.
Methods
hsCRP and low-density lipoprotein (LDL) levels were determined in 2741 all-comers admitted to the cardiological ward of our tertiary referral hospital between June 2016 and June 2018. Patients without CHD, with acute coronary syndrome, chronic or recurrent systemic infection, use of immunosuppressant or anti-inflammatory agents, chronic inflammatory diseases, chemotherapy, terminal organ failure, traumatic injury and pregnancy were excluded.
Results
856 patients with stable CHD were included. 42.7% of those had elevated hsCRP ≥ 2 mg/l. Within the group of patients with LDL-cholesterol < 70 mg/dl, 30.9% shared increased hsCRP indicating residual inflammation. After multivariate adjusted backward selection elevated Lipoprotein (a) (OR 1.61, p = 0.048), elevated proBNP (OR 2.57, p < 0.0001), smoking (OR 1.70, p = 0.022), and obesity (OR 2.28, p = 0.007) were associated with elevated hsCRP. In contrast, the use of ezetimibe was associated with normal hsCRP (OR 0.51, p = 0.014). In the subgroup of patients with on-target LDL-cholesterol < 70 mg/dl, backward selection identified elevated proBNP (OR 3.49, p = 0.007) as independent predictor of elevated hsCRP in patients with LDL-cholesterol < 70 mg/dl.
Conclusion
One-third of all-comers patients with CHD showed increased levels of hsCRP despite a LDL-cholesterol < 70 mg/dl potentially qualifying for an anti-inflammatory therapy. Elevated proBNP is an independent risk factor for hsCRP elevation.



Clin Res Cardiol: 18 Jul 2019; epub ahead of print
Peikert A, Kaier K, Merz J, Manhart L, ... Zirlik A, Stachon P
Clin Res Cardiol: 18 Jul 2019; epub ahead of print | PMID: 31325043
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Impact:
Abstract

\"Myocardial transit-time\" (MyoTT): a novel and easy-to-perform CMR parameter to assess microvascular disease.

Chatzantonis G, Bietenbeck M, Florian A, Meier C, ... Reinecke H, Yilmaz A
Background
Myocardial microvascular disease may occur during the disease course of different cardiac as well as systemic disorders. With the present study, we introduce a novel and easy-to-perform cardiovascular magnetic resonance (CMR) parameter named \"myocardial transit-time\" (MyoTT).
Methods
N = 20 patients with known hypertrophic cardiomyopathy (HCM) and N = 20 control patients without relevant cardiac disease underwent dedicated CMR studies on a 1.5-T MR scanner. The CMR protocol comprised cine and late-gadolinium-enhancement (LGE) imaging as well as first-pass perfusion acquisitions at rest for MyoTT measurement. MyoTT was defined as the blood circulation time from the orifice of the coronary arteries to the pooling in the coronary sinus (CS), and accordingly measured as the temporal difference between the appearances of CMR contrast agent in the aortic root and the CS reflecting the transit-time of gadolinium in the myocardial microvasculature.
Results
Patients with HCM had a significantly prolonged MyoTT compared to controls (11.0 (9.1-14.5) s vs. 6.5 (4.8-8.4) s, p < 0.001). This significant difference did not change when the individual heart rate was taken into consideration (MyoTT indexed, p < 0.001). Significant correlations were found between MyoTT and maximal left ventricular (LV) wall thickness (r = 0.771, p < 0.001), MyoTT and presence of LGE (r = 0.760, p < 0.001) as well as MyoTT and LV global longitudinal strain (r = 0.672, p < 0.001). ROC analysis resulted in an area-under-curve (AUC) of 0.90 for MyoTT and showed an optimal sensitivity/specificity cut-off of 7.85 s to differentiate HCM from controls.
Conclusion
\"Myocardial transit-time\" is a novel and easy-to-perform CMR parameter that allows a quick assessment of the extent of myocardial microvascular disease. This novel CMR parameter may open new vistas in the assessment of microvascular disease-not only in HCM patients. Future studies will show the usefulness and clinical relevance of this novel CMR parameter.



Clin Res Cardiol: 17 Jul 2019; epub ahead of print
Chatzantonis G, Bietenbeck M, Florian A, Meier C, ... Reinecke H, Yilmaz A
Clin Res Cardiol: 17 Jul 2019; epub ahead of print | PMID: 31321491
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Impact:
Abstract

Validation of simple measures of aortic distensibility based on standard 4-chamber cine CMR: a new approach for clinical studies.

Stoiber L, Ghorbani N, Kelm M, Kuehne T, ... Gebker R, Kelle S
Objective
Aortic distensibility (AD) represents a well-established parameter of aortic stiffness. It remains unclear, however, whether AD can be obtained with high reproducibility in standard 4-chamber cine CMR images of the descending aorta. This study investigated the intra- and inter-observer agreement of AD based on different angles of the aorta and provided a sample size calculation of AD for future trials.
Methods
Thirty-one patients underwent CMR. Angulation of the descending aorta was performed to obtain strictly transversal and orthogonal cross-sectional aortic areas. AD was obtained both area and diameter based.
Results
For area-based values, inter-observer agreement was highest for 4-chamber AD (ICC 0.97; 95% CI 0.93-99), followed by orthogonal AD (ICC 0.96; 95% CI 0.91-98) and transversal AD (ICC 0.93; 95% CI 0.80-97). For diameter-based values, agreement was also highest for 4-chamber AD (ICC 0.97; 95% CI 0.94-99), followed by orthogonal AD (ICC 0.96; 95% CI 0.92-98) and transversal AD (ICC 0.91; 95% CI 0.77-96). Bland-Altman plots confirmed a small variation among observers. Sample size calculation showed a sample size of 12 patients to detect a change in 4-chamber AD of 1 × 10 mmHg with either the area or diameter approach.
Conclusion
AD measurements are highly reproducible and allow an accurate and rapid assessment of arterial compliance from standard 4-chamber cine CMR.



Clin Res Cardiol: 12 Jul 2019; epub ahead of print
Stoiber L, Ghorbani N, Kelm M, Kuehne T, ... Gebker R, Kelle S
Clin Res Cardiol: 12 Jul 2019; epub ahead of print | PMID: 31302712
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Impact:
Abstract

Influence of glycoprotein IIb/IIIa inhibitors on bleeding events after successful resuscitation and percutaneous coronary intervention.

Biever PM, Staudacher DL, Degott J, Lang CN, Bode C, Wengenmayer T
Aim
Cardiac arrest is the most serious complication in acute coronary syndromes. Glycoprotein IIb/IIIa inhibitors (GPI) are used in selected acute coronary syndrome patients. If the use of GPI leads to an increase in bleeding events and influences survival in patients after cardiac arrest is unknown.
Methods
We report retrospective data of a single center registry of patients after successful intra- and out-of-hospital cardiac arrest between 2002 and 2013. Inclusion criteria were survival for at least 6 h and successful percutaneous coronary intervention (PCI) within the first 24 h. Patients treated with other fibrinolytic agents or being supported by an extracorporeal life support system were excluded from the analysis.
Results
310 patients were included in our study. 204 received GPI (GPI+), 106 did not (GPI-). Patients in the GPI+ group were significantly younger (62.8 vs. 68.0 years, p < 0.001) and had larger myocardial infarction sizes (maximum creatine kinase 3407 vs. 1450 U/l, p < 0.001). CPR duration, SOFA score and first lactate did not differ between the groups. Any bleeding occurred significantly more often in the GPI+ group (83.3% vs. 67.0%, p = 0.001). Decline of hemoglobin within the first 24 h was higher in the GPI+ group (-1.59 ± 1.71 mg/dl vs. -0.88 ± 1.95 mg/dl, p = 0.004), number of transfused packed red blood cells in the first 4 days, however, were similar (1.18 ± 0.40 vs. 0.90 ± 0.41 packs, p = 0.378). Survival at ICU discharge was significantly higher in the GPI+ group (77.5% vs. 63.2%, p = 0.008). The use of GPI was an independent predictor of hospital survival (OR 3.07, CI 1.31-7.20, p = 0.010). The positive effect for GPI persisted after nearest neighbor propensity score matching including 144 patients (OR 3.27, 95% CI 1.48-7.21, p = 0.003).
Conclusion
After cardiac arrest, bleeding incidence was significantly higher in patients treated with GPI. Incidence of bleedings requiring transfusion, however, was similar. In this retrospective analysis, the use of GPI was an independent predictor of hospital survival. We suggest that GPI may not be withheld from cardiac arrest survivors due to potential risk of bleeding.



Clin Res Cardiol: 11 Jul 2019; epub ahead of print
Biever PM, Staudacher DL, Degott J, Lang CN, Bode C, Wengenmayer T
Clin Res Cardiol: 11 Jul 2019; epub ahead of print | PMID: 31300835
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Impact:
Abstract

Drug interactions with oral anticoagulants in German nursing home residents: comparison between vitamin K antagonists and non-vitamin K antagonist oral anticoagulants based on two nested case-control studies.

Jobski K, Hoffmann F, Herget-Rosenthal S, Dörks M
Background
Vitamin K antagonists (VKAs) are susceptible to drug-drug interactions. Non-VKA oral anticoagulants (NOACs) have a decreased sensitivity to pharmacokinetic interactions and might be therefore considered superior in patients treated with multiple drugs. The objective of this study was to compare the risk of serious bleeding associated with interacting drugs in German nursing home residents treated with VKA or NOAC.
Methods
Using claims data of new nursing home residents aged ≥ 65 years (2010-2014) we conducted separate nested case-control analyses within two cohorts of patients treated with VKA or NOAC, respectively. Cases were defined as patients hospitalized for serious bleeding. For each case, up to 20 controls were selected by risk-set sampling. Conditional logistic regression was used to obtain confounder-adjusted odds ratios (aORs) and 95% confidence intervals (CI) for the risk of bleeding associated with VKA or NOAC use and interacting drugs compared with the use of the respective oral anticoagulant alone.
Results
Among 127,227 new nursing home residents, 16,804 patients received oral anticoagulation. Based on 372 cases and 7281 matched controls, the highest risk of bleeding in VKA users was observed for the concomitant use of antibiotics (aOR 3.00; CI 2.11-4.27) vs. VKA use alone, followed by non-steroidal anti-inflammatory drugs (1.66; 1.13-2.43). Among 243 NOAC cases and 4776 matched controls, elevated risks for bleeding were observed for the use of heparins (2.05; 1.25-3.36) and platelet inhibitors (1.92; 1.36-2.72).
Conclusions
Concomitant medication needs to be prescribed cautiously and monitored closely in nursing home residents treated with oral anticoagulants.



Clin Res Cardiol: 07 Jul 2019; epub ahead of print
Jobski K, Hoffmann F, Herget-Rosenthal S, Dörks M
Clin Res Cardiol: 07 Jul 2019; epub ahead of print | PMID: 31286199
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Impact:
Abstract

Association of NT-proBNP and GDF-15 with markers of a prothrombotic state in patients with atrial fibrillation off anticoagulation.

Matusik PT, Małecka B, Lelakowski J, Undas A

We investigated whether growth differentiation factor-15 (GDF-15), also known as macrophage inhibitory cytokine-1 (MIC-1), levels are associated with a prothrombotic state in atrial fibrillation (AF) as compared to N-terminal pro-B-type natriuretic peptide (NT-proBNP) and high-sensitivity cardiac troponin I (cTnI-hs). In 103 patients with AF assessed off anticoagulation (age: 71.0 [65.0-76.0] years; CHADS-VASc score: 4.6 ± 1.7), we measured endogenous thrombin potential (ETP), plasma fibrin clot permeability (K, a measure of clot density) and clot lysis time (CLT) and other hemostatic parameters, along with GDF-15, NT-proBNP, and cTnI-hs. GDF-15 positively correlated with ETP and CLT (r = 0.25, P = 0.01 and R = 0.56, P < 0.0001, respectively) but not with K, von Willebrand factor, thrombin-activatable fibrinolysis inhibitor, plasminogen, antiplasmin or tissue-type plasminogen activator antigen. NT-proBNP showed a stronger association with ETP (r = 0.60, P < 0.0001) and a similar correlation with CLT (R = 0.53, P < 0.0001), while cTnI-hs correlated solely with CLT (R = 0.25, P = 0.01). After adjustment for clinical and laboratory parameters, GDF-15 was a better independent predictor of CLT (unstandardized coefficient B 0.009; 95% confidence interval [CI] 0.006-0.012) than NT-proBNP (B 0.007; 95% CI 0.004-0.010, R (2) = 0.51; P < 0.0001); while among the three biomarkers, only NT-proBNP was an independent predictor of ETP. Elevated GDF-15 and NT-proBNP independently predict impaired fibrin clot lysability, while NT-proBNP is a key predictor of heightened thrombin formation in AF. Our findings suggest that a predictive value of NT-proBNP and GDF-15 in AF could be in part attributed to their association with prothrombotic blood alterations.



Clin Res Cardiol: 05 Jul 2019; epub ahead of print
Matusik PT, Małecka B, Lelakowski J, Undas A
Clin Res Cardiol: 05 Jul 2019; epub ahead of print | PMID: 31280356
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Impact:
Abstract

Culprit vessel-related myocardial mechanics and prognostic implications following acute myocardial infarction.

Backhaus SJ, Kowallick JT, Stiermaier T, Lange T, ... Schuster A, Eitel I
Background
Prognosis in acute myocardial infarction (AMI) depends on the amount of infarct-related artery (IRA)-subtended myocardium and associated damage but has not been described in great detail. Consequently, we sought to describe IRA-associated pathophysiological consequences using cardiac magnetic resonance (CMR).
Methods
1235 AMI patients (n = 795 ST-elevation (STEMI) and 440 non-STEMI) underwent CMR following percutaneous coronary intervention. Blinded core-laboratory data were compared according to left anterior descending (LAD), left circumflex (LCx) and right coronary artery (RCA) regarding major adverse clinical events (MACE) within 12 months. Left ventricular (LV) global longitudinal/circumferential/radial (GLS/GCS/GRS) as well as left atrial (LA) total (ε), passive (ε) and active (ε) strains were determined using CMR-feature tracking. Tissue characterisation included infarct size (IS) and microvascular obstruction.
Results
LAD and LCx were associated with higher mortality compared to RCA lesions (4.6% and 4.4% vs 1.6%). LAD lesions showed largest IS (16.8%), largest ventricular [LV ejection fraction (EF) 47.4%, GLS - 13.2%, GCS - 20.8%] and atrial (ε 20.2%) impairment. There was less impairment in LCx (IS 11.8%, LVEF 50.8%, GLS - 17.4%, GCS - 25.0%, ε 20.7%) followed by RCA lesions (IS 11.3%, LVEF 50.8%, GLS - 19.1%, GCS - 26.6%, ε 21.7%). In AUC analyses, ε (LAD, RCA) and GLS (LCx) best predicted MACE (AUC > 0.69). Multivariate analyses identified ε (p = 0.017) in LAD and GLS (p = 0.034) in LCx infarcts as independent predictors of MACE.
Conclusions
CMR allows IRA-specific phenotyping and characterisation of morphologic and functional changes. These alterations carry infarct-specific prognostic implications, and may represent novel diagnostic and therapeutic targets following AMI.
Trial registration
ClinicalTrials.gov: NCT00712101 and NCT01612312.



Clin Res Cardiol: 04 Jul 2019; epub ahead of print
Backhaus SJ, Kowallick JT, Stiermaier T, Lange T, ... Schuster A, Eitel I
Clin Res Cardiol: 04 Jul 2019; epub ahead of print | PMID: 31278521
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Impact:
Abstract

Incidence, predictors, and relevance of acute kidney injury in patients undergoing left atrial appendage closure with Amplatzer occluders: a multicentre observational study.

Sedaghat A, Vij V, Streit SR, Schrickel JW, ... Nickenig G, Gloekler S
Aims
Acute kidney injury (AKI) remains a frequent complication after cardiac interventions, such as left atrial appendage closure (LAAC), yet limited data are available on the incidence and clinical implication of AKI in this setting. We sought to assess incidence, predictors and relevance of AKI after LAAC.
Methods and results
We retrospectively analyzed 95 LAAC patients in three European centers. AKI was defined according to the Acute Kidney Injury Network (AKIN) classification. The incidence of AKI was 13.7% with mild AKI in 92.3% and AKI stage > II in 7.7%. Total contrast volume was not linked to the occurrence of AKI (AKI: 127 ± 83 vs. no AKI: 109 ± 92 ml, p = 0.41), however increasing contrast volume (CV) to glomerular filtration rate (GFR) ratio (CV/GFR ratio) was associated with an increased risk of AKI (OR, per unit increase: 1.24, 95% CI 0.97-1.58, p = 0.08). ROC-analysis revealed a moderate predictive value of CV/GFR ratio for the prediction of AKI (AUC: 0.67, 95% CI 0.50-0.84, p = 0.05). Furthermore, AKI was associated with significantly increased mortality 6 months and 1 year after LAAC. No significant difference in the incidence of AKI was observed between patients with mere fluoroscopic and additional echocardiographic guidance (16.3% vs. 11.5%, p = 0.56).
Conclusion
Whereas mild AKI is common in patients after LAAC, severe AKI is rare. AKI after LAAC is associated with poor baseline renal function, increased doses of contrast (CV/GFR ratio) and impaired outcome. Future studies will be needed to elaborate the benefit of reducing or avoiding contrast volume regarding this endpoint.



Clin Res Cardiol: 04 Jul 2019; epub ahead of print
Sedaghat A, Vij V, Streit SR, Schrickel JW, ... Nickenig G, Gloekler S
Clin Res Cardiol: 04 Jul 2019; epub ahead of print | PMID: 31278520
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Impact:
Abstract

Clinical, angiographic and echocardiographic correlates of epicardial and microvascular spasm in patients with myocardial ischaemia and non-obstructive coronary arteries.

Montone RA, Niccoli G, Russo M, Giaccari M, ... Lanza GA, Crea F
Background
Coronary vasomotor dysfunction represents an important mechanism responsible for myocardial ischaemia in patients with non-obstructive coronary artery disease (CAD). The use of invasive provocative tests allows identifying patients with epicardial or microvascular spasm. Of note, clinical characteristics associated with the occurrence of epicardial or microvascular spasm have still not completely clarified.
Methods and results
We prospectively enrolled consecutive patients undergoing coronary angiography for suspected myocardial ischaemia/necrosis with evidence of non-obstructive CAD and undergoing intracoronary provocative test for suspected vasomotor dysfunction. Patients with a positive provocative test were enrolled. Clinical, echocardiographic and angiographic characteristics of patients were evaluated according to the pattern of vasomotor dysfunction (epicardial vs. microvascular spasm). We included 120 patients [68 patients with stable angina and 52 patients with myocardial infarction and non-obstructive coronary arteries (MINOCA)]. In particular, 77 (64.2%) patients had a provocative test positive for epicardial spasm and 43 (35.8%) patients for microvascular spasm. Patients with epicardial spasm were more frequently males, smokers, had higher rates of diffuse coronary atherosclerosis at angiography and more frequently presented with MINOCA. On the other hand, patients with microvascular spasm presented more frequently diastolic dysfunction. At multivariate logistic regression analysis male sex, smoking, and diffuse coronary atherosclerosis were independent predictors for the occurrence of epicardial spasm.
Conclusions
Our study showed that specific clinical features are associated with different responses to intracoronary provocative test. Epicardial spasm is more frequent in males and in MINOCA patients, whereas microvascular spasm is more frequent in patients with stable angina and is associated with diastolic dysfunction.



Clin Res Cardiol: 02 Jul 2019; epub ahead of print
Montone RA, Niccoli G, Russo M, Giaccari M, ... Lanza GA, Crea F
Clin Res Cardiol: 02 Jul 2019; epub ahead of print | PMID: 31270616
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Abstract

Characteristics and outcomes of HFpEF with declining ejection fraction.

Park JJ, Park CS, Mebazaa A, Oh IY, ... Oh BH, Choi DJ
Objective
Some patients with heart failure with preserved ejection fraction (HFpEF) experience declining of left-ventricular ejection fraction (LVEF) during follow-up. We aim to investigate the characteristics and outcomes of patients with HF with declining ejection fraction (HFdEF).
Methods
We analyzed a prospective, nationwide multicenter cohort with consecutive patients with acute HF enrolled from March 2011 to December 2014. HFpEF was defined as LVEF ≥ 50% at index admission. After 1 year, HFpEF patients were further classified as HFdEF (LVEF ≥ 50% at admission and < 50% at 1 year), and persistent HFpEF (LVEF ≥ 50% both at admission and 1 year). Primary outcome was 4-year all-cause mortality according to HF type from HFdEF diagnosis.
Results
Of patients with HFpEF, 426 (90.4%) were diagnosed as having persistent HFpEF and 45 (9.6%) as having HFdEF. Natriuretic peptide level was an independent predictor of HFdEF (natriuretic peptide level > median: odds ratio: 3.20, 95% confidence interval [CI]: 1.42-7.25, P = 0.005). During 4-year follow-up, patients with HFdEF had higher mortality than those with persistent HFpEF (Log-rank P < 0.001). After adjustment, HFdEF was associated with an almost twofold increased risk for mortality (hazard ratio 1.82, 95% CI 1.13-2.96, P = 0.015). The use of beta-blockers, renin-angiotensin system inhibitors, and mineralocorticoid receptor antagonists was not associated with improved prognosis of patients with HFdEF.
Conclusions
HFdEF is a distinct HF type with grave outcomes. Further investigations that focus on HFdEF are warranted to better understand and develop treatment strategies for these high-risk patients.
Clinical trial registration
ClinicalTrial.gov identifier: NCT01389843. URL: https://clinicaltrials.gov/ct2/show/NCT01389843 .



Clin Res Cardiol: 01 Jul 2019; epub ahead of print
Park JJ, Park CS, Mebazaa A, Oh IY, ... Oh BH, Choi DJ
Clin Res Cardiol: 01 Jul 2019; epub ahead of print | PMID: 31267239
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Abstract

The influence of atrial fibrillation on the levels of NT-proBNP versus GDF-15 in patients with heart failure.

Santema BT, Chan MMY, Tromp J, Dokter M, ... Lam CSP, Voors AA
Background
In heart failure (HF), levels of NT-proBNP are influenced by the presence of concomitant atrial fibrillation (AF), making it difficult to distinguish between HF versus AF in patients with raised NT-proBNP. It is unknown whether levels of GDF-15 are also influenced by AF in patients with HF. In this study we compared the plasma levels of NT-proBNP versus GDF-15 in patients with HF in AF versus sinus rhythm (SR).
Methods
In a post hoc analysis of the index cohort of BIOSTAT-CHF (n = 2516), we studied patients with HF categorized into three groups: (1) AF at baseline (n = 733), (2) SR at baseline with a history of AF (n = 183), and (3) SR at baseline and no history of AF (n = 1025). The findings were validated in the validation cohort of BIOSTAT-CHF (n = 1738).
Results
Plasma NT-proBNP levels of patients who had AF at baseline were higher than those of patients in SR (both with and without a history of AF), even after multivariable adjustment (3417 [25th-75th percentile 1897-6486] versus 1788 [682-3870], adjusted p < 0.001, versus 2231 pg/mL [902-5270], adjusted p < 0.001). In contrast, after adjusting for clinical confounders, the levels of GDF-15 were comparable between the three groups (3179 [2062-5253] versus 2545 [1686-4337], adjusted p = 0.36, versus 2294 [1471-3855] pg/mL, adjusted p = 0.08). Similar patterns of both NT-proBNP and GDF-15 were found in the validation cohort.
Conclusion
These data show that in patients with HF, NT-proBNP is significantly influenced by underlying AF at time of measurement and not by previous episodes of AF, whereas the levels of GDF-15 are not influenced by the presence of AF. Therefore, GDF-15 might have additive value combined with NT-proBNP in the assessment of patients with HF and concomitant AF.



Clin Res Cardiol: 30 Jun 2019; epub ahead of print
Santema BT, Chan MMY, Tromp J, Dokter M, ... Lam CSP, Voors AA
Clin Res Cardiol: 30 Jun 2019; epub ahead of print | PMID: 31263996
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Abstract

Long- and short-term association of low-grade systemic inflammation with cardiovascular mortality in the LURIC study.

Kälsch AI, Scharnagl H, Kleber ME, Windpassinger C, ... März W, Malle E
Background
The present study aimed to evaluate biomarkers representing low-grade systemic inflammation and their association with cardiovascular mortality in the Ludwigshafen Risk and Cardiovascular Health (LURIC) study.
Methods
The included 3134 consecutive patients underwent coronary angiography between June 1997 and May 2001 with a median follow-up of 9.9 years. Plasma levels of IL-6, and acute-phase reactants serum amyloid A (SAA) and C-reactive protein (CRP) were measured. SAA and IL-6 polymorphisms were genotyped.
Results
During a median observation time of 9.9 years, 949 deaths (30.3%) occurred, of these 597 (19.2%) died from cardiovascular causes. High plasma levels of IL-6, CRP and SAA were associated with unstable CAD, as well as established risk factors including type 2 diabetes mellitus, smoking, low glomerular filtration rate, low TGs and low HDL-C. After adjusting for established cardiovascular risk markers and the other two inflammatory markers, SAA was found to be an independent risk factor for cardiovascular mortality after a short-term follow-up (6 months-1 year) with a HR per SD of 1.41. IL-6 was identified as an independent risk factor for long-term follow-up (3, 5, and 9.9 years) with HRs per SD of 1.21, 1.22 and 1.18. CRP lost significance after adjustment. Although 6 out of 27 SAA SNPs were significantly associated with SAA plasma concentrations, the genetic risk score was not associated with cardiovascular mortality.
Conclusions
The present findings from the large, prospective LURIC cohort underline the importance of inflammation in CAD and the prognostic relevance of inflammatory biomarkers that independently predict cardiovascular mortality.



Clin Res Cardiol: 30 Jun 2019; epub ahead of print
Kälsch AI, Scharnagl H, Kleber ME, Windpassinger C, ... März W, Malle E
Clin Res Cardiol: 30 Jun 2019; epub ahead of print | PMID: 31263995
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Abstract

Authorship: from credit to accountability. Reflections from the Editors\' Network.

Alfonso F, Zelveian P, Monsuez JJ, Aschermann M, ... Shumakov V,

The Editors\' Network of the European Society of Cardiology provides a dynamic forum for editorial discussions and endorses the recommendations of the International Committee of Medical Journal Editors (ICMJE) to improve the scientific quality of biomedical journals. Authorship confers credit and important academic rewards. Recently, however, the ICMJE emphasized that authorship also requires responsibility and accountability. These issues are now covered by the new (fourth) criterion for authorship. Authors should agree to be accountable and ensure that questions regarding the accuracy and integrity of the entire work will be appropriately addressed. This review discusses the implications of this paradigm shift on authorship requirements with the aim of increasing awareness on good scientific and editorial practices.



Clin Res Cardiol: 29 Jun 2019; 108:723-729
Alfonso F, Zelveian P, Monsuez JJ, Aschermann M, ... Shumakov V,
Clin Res Cardiol: 29 Jun 2019; 108:723-729 | PMID: 31041501
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Abstract

Atrial fibrillation ablation strategies and outcome in patients with heart failure: insights from the German ablation registry.

Eitel C, Ince H, Brachmann J, Kuck KH, ... Senges J, Tilz RR
Background
Heart failure (HF) and atrial fibrillation (AF) often coexist, but data on the prognostic value of differing ablation strategies according to left ventricular ejection fraction (LVEF) are rare.
Methods and results
From January 2007 until January 2010, 728 patients with HF were enrolled in the multi-center German ablation registry prior to AF catheter ablation. Patients were divided into three groups according to LVEF: HF with preserved LVEF (≥ 50%, HFpEF, n = 333), mid-range LVEF (40-49%, HFmrEF, n = 207), and reduced LVEF (< 40%, HFrEF, n = 188). Ablation strategies differed significantly between the three groups with the majority of patients with HFpEF (83.4%) and HFmrEF (78.4%) undergoing circumferential pulmonary vein isolation vs. 48.9% of patients with HFrEF. The latter underwent ablation of the atrioventricular (AV) node in 47.3%. Major complications did not differ between the groups. Kaplan-Meier survival analysis demonstrated a significant mortality increase in patients with HFrEF (6.1% in HFrEF vs. 1.5% in HFmrEF vs. 1.9% in HFpEF, p = 0.009) that was limited to patients undergoing ablation of the AV node.
Conclusions
Catheter ablation strategies differ significantly in patients with HFpEF, HFmrEF, and HFrEF. In almost 50% of patients with HFrEF AV-node ablation was performed, going along with a significant increase in mortality rate. These results should raise efforts to further evaluate the prognostic effect of ablation strategies in HF patients.



Clin Res Cardiol: 29 Jun 2019; 108:815-823
Eitel C, Ince H, Brachmann J, Kuck KH, ... Senges J, Tilz RR
Clin Res Cardiol: 29 Jun 2019; 108:815-823 | PMID: 30788620
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This program is still in alpha version.