Journal: Clin Res Cardiol

Sorted by: date / impact
Abstract

Deferral of non-emergency cardiac procedures is associated with increased early emergency cardiovascular hospitalizations.

Andreß S, Stephan T, Felbel D, Mack A, ... Imhof A, Rattka M
Background
During the COVID-19 pandemic, in anticipation of a demand surge for high-care hospital beds, many hospitals postponed non-emergency interventions of cardiac patients.
Aim
The aim of this study was to assess the outcomes of cardiac patients whose non-emergency interventions had been deferred during the COVID-19 pandemic.
Methods
Patients whose non-emergency cardiac intervention had been cancelled between March 19th and April 30th, 2020 were included (study group). All patients were considered as deferrable according to current recommendations. Patients\' outcomes after 12 months were compared to a seasonal control group who underwent non-emergency interventions in 2019 as scheduled. The primary endpoint was a composite of emergency cardiovascular hospitalization and death. Secondary endpoints were levels of symptoms and cardiac biomarkers.
Results
Outcomes of 193 consecutive patients in the study group were assessed and compared to 216 controls. The primary endpoint occurred significantly more often in the study group (HR 2.42, 95%CI 1.63-3.61, p < 0.001). This was driven by an increase in hospitalizations. Subgroup analyses showed that especially patients with a deferred transcatheter heart valve intervention experienced early emergency hospitalization (HR 9.55, 95%CI 3.70-24.62, p < 0.001). These findings were accompanied by more pronounced symptoms and higher biomarker levels.
Conclusions
Deferral of non-emergency cardiac interventions to meet the higher demand for hospital beds during the COVID-19 crisis is associated with early emergency cardiovascular hospitalizations. Patients suffering from valvular heart disease especially constitute a vulnerable group. Consequently, our results suggest that current recommendations on the management of cardiovascular disease during the COVID-19 pandemic need revision.

© 2022. The Author(s).

Clin Res Cardiol: 23 May 2022; epub ahead of print
Andreß S, Stephan T, Felbel D, Mack A, ... Imhof A, Rattka M
Clin Res Cardiol: 23 May 2022; epub ahead of print | PMID: 35604454
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Abstract

Effect of hyperglycaemia in combination with moxifloxacin on cardiac repolarization in male and female patients with type I diabetes.

Taubel J, Pimenta D, Cole ST, Graff C, Kanters JK, Camm AJ
Background
Patients with Type 1 diabetes mellitus have been shown to be at a two to ten-fold higher risk of sudden cardiac death (SCD) (Svane et al., Curr Cardiol 2020; 22:112) than the general population, but the underlying mechanism is unclear. Hyperglycaemia is a recognised cause of QTc prolongation; a state patients with type 1 diabetes are more prone to, potentially increasing their risk of ventricular arrhythmia. Understanding the QTc prolongation effect of both hyperglycaemia and the concomitant additive risk of commonly prescribed QTc-prolonging drugs such as Moxifloxacin may help to elucidate the mechanism of sudden cardiac death in this cohort. This single-blinded, placebo-controlled study investigated the extent to which hyperglycaemia prolongs the QTc in controlled conditions, and the potential additive risk of QTc-prolonging medications.
Methods
21 patients with type 1 diabetes mellitus were enrolled to a placebo-controlled crossover study at a single clinical trials unit. Patients underwent thorough QTc assessment throughout the study. A \'hyperglycaemic clamp\' of oral and intravenous glucose was administered with a target blood glucose of > 25 mM and maintained for 2 h on day 1 and day 3, alongside placebo on day 1 and moxifloxacin on day 3. Day 2 served as a control day between the two active treatment days. Thorough QTc assessment was conducted at matched time points over 3 days, and regular blood sampling was undertaken at matched time intervals for glucose levels and moxifloxacin exposure.
Results
Concentration-effect modelling showed that acute hyperglycaemia prolonged the QTc interval in female and male volunteers with type 1 diabetes by a peak mean increase of 13 ms at 2 h. Peak mean QTc intervals after the administration of intravenous Moxifloxacin during the hyperglycaemic state were increased by a further 9 ms at 2 h, to 22 ms across the entire study population. Regression analysis suggested this additional increase was additive, not exponential. Hyperglycaemia was associated with a significantly greater mean QTc-prolonging effect in females, but the mean peak increase with the addition of moxifloxacin was the same for males and females. This apparent sex difference was likely due to the exclusive use of basal insulin in the male patients, which provided a low level of exogenous insulin during the study assessments thereby mitigating the effects of hyperglycaemia on QTc. This effect was partially overcome by Moxifloxacin administration, suggesting both hyperglycaemia and moxifloxacin prolong QTc by different mechanisms, based on subinterval analysis.
Conclusions
Hyperglycaemia was found to be a significant cause of QTc prolongation and the additional effect of a QTc-prolonging positive control (moxifloxacin) was found to be additive. Given the high risk of sudden cardiac death in type 1 diabetes mellitus, extra caution should be exercised when prescribing any medication in this cohort for QTc effects, and further research needs to be undertaken to elucidate the exact mechanism underlying this finding and explore the potential prescribing risk in diabetes.
Trial registration
NCT number: NCT01984827.

© 2022. The Author(s).

Clin Res Cardiol: 21 May 2022; epub ahead of print
Taubel J, Pimenta D, Cole ST, Graff C, Kanters JK, Camm AJ
Clin Res Cardiol: 21 May 2022; epub ahead of print | PMID: 35596784
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Abstract

Reliability of estimating left ventricular ejection fraction in clinical routine: a validation study of the SWEDEHEART registry.

Lenell J, Lindahl B, Karlsson P, Batra G, ... Spaak J, Baron T
Objective
Patients hospitalized with acute coronary syndrome (ACS) in Sweden routinely undergo an echocardiographic examination with assessment of left ventricular ejection fraction (LVEF). LVEF is a measurement widely used for outcome prediction and treatment guidance. The obtained LVEF is categorized as normal (> 50%) or mildly, moderately, or severely impaired (40-49, 30-39, and < 30%, respectively) and reported to the nationwide registry for ACS (SWEDEHEART). The purpose of this study was to determine the reliability of the reported LVEF values by validating them against an independent re-evaluation of LVEF.
Methods
A random sample of 130 patients from three hospitals were included. LVEF re-evaluation was performed by two independent reviewers using the modified biplane Simpson method and their mean LVEF was compared to the LVEF reported to SWEDEHEART. Agreement between reported and re-evaluated LVEF was assessed using Gwet\'s AC2 statistics.
Results
Analysis showed good agreement between reported and re-evaluated LVEF (AC2: 0.76 [95% CI 0.69-0.84]). The LVEF re-evaluations were in agreement with the registry reported LVEF categorization in 86 (66.0%) of the cases. In 33 (25.4%) of the cases the SWEDEHEART-reported LVEF was lower than re-evaluated LVEF. The opposite relation was found in 11 (8.5%) of the cases (p < 0.005).
Conclusion
Independent validation of SWEDEHEART-reported LVEF shows an overall good agreement with the re-evaluated LVEF. However, a tendency towards underestimation of LVEF was observed, with the largest discrepancy between re-evaluated LVEF and registry LVEF in subjects with subnormal LV-function in whom the reported assessment of LVEF should be interpreted more cautiously.

© 2022. The Author(s).

Clin Res Cardiol: 17 May 2022; epub ahead of print
Lenell J, Lindahl B, Karlsson P, Batra G, ... Spaak J, Baron T
Clin Res Cardiol: 17 May 2022; epub ahead of print | PMID: 35581481
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Abstract

High prevalence of reduced fertility and use of assisted reproductive technology in a German cohort of patients with peripartum cardiomyopathy.

Pfeffer TJ, List M, Schippert C, Auber B, ... Bauersachs J, Hilfiker-Kleiner D
Background
Over the past decades the use of assisted reproduction technology (ART) increased worldwide. ARTs are associated with an elevated risk for cardiovascular complications. However, a potential relation between subfertility/ARTs and the heart disease peripartum cardiomyopathy (PPCM) has not been systematically analyzed yet.
Methods
A retrospective cohort study was carried out, including n = 111 PPCM patients from the German PPCM registry. Data from PPCM patients were compared to those from postpartum women in the German general population.
Results
The prevalence of reported subfertility was high among PPCM patients (30%; 33/111). Most of the subfertile PPCM patients (55%; 18/33) obtained vitro fertilizations (IVF) or intracytoplasmic sperm injections (ICSI). PPCM patients were older (p < 0.0001), the percentage of born infants conceived by IVF/ICSI was higher (p < 0.0001) with a higher multiple birth (p < 0.0001), C-section (p < 0.0001) and preeclampsia rate (p < 0.0001), compared to postpartum women. The cardiac outcome was comparable between subfertile and fertile PPCM patients. Whole exome sequencing in a subset of n = 15 subfertile PPCM patients revealed that 33% (5/15) carried pathogenic or likely pathogenic gene variants associated with cardiomyopathies and/or cancer predisposition syndrome.
Conclusions
Subfertility occurred frequently among PPCM patients and was associated with increased age, hormonal disorders, higher twin pregnancy rate and high prevalence of pathogenic gene variants suggesting a causal relationship between subfertility and PPCM. Although this study found no evidence that the ART treatment per se increases the risk for PPCM or the risk for an adverse outcome, women with subfertility should be closely monitored for signs of peripartum heart failure.

© 2022. The Author(s).

Clin Res Cardiol: 13 May 2022; epub ahead of print
Pfeffer TJ, List M, Schippert C, Auber B, ... Bauersachs J, Hilfiker-Kleiner D
Clin Res Cardiol: 13 May 2022; epub ahead of print | PMID: 35562615
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Abstract

Relationships between sympathetic markers and heart rate thresholds for cardiovascular risk in chronic heart failure.

Grassi G, Seravalle G, Vanoli J, Facchetti R, Spaziani D, Mancia G
Background
Results of recent clinical trials have shown that in heart failure (HF) heart rate (HR) values > 70 beats/minute are associated with an increased cardiovascular risk. No information is available on whether the sympathetic nervous system is differently activated in HF patients displaying resting HR values above or below this cutoff.
Methods
In 103 HF patients aged 62.7 ± 0.9 (mean ± SEM) years and in 62 heathy controls of similar age we evaluated muscle sympathetic nerve traffic (MSNA, microneurography) and venous plasma norepinephrine (NE, HPLC assay), subdividing the subjects in different groups according to their resting clinic and 24-h HR values.
Results
In HF progressively greater values of clinic or 24-h HR were associated with a progressive increase in both MSNA and NE. HR cutoff values adopted in large scale clinical trials for determining cardiovascular risk, i.e., 70 beats/minute, were associated with MSNA values significantly greater than the ones detected in patients with lower HR, this being the case also for NE. In HF both MSNA and NE were significantly related to clinic (r = 0.92, P < 0.0001 and r = 0.81, P < 0.0001, respectively) and 24-h (r = 0.91, P < 0.0001 and r = 0.79, P < 0.0001, respectively) HR. The behavior of sympathetic markers described in HF was specific for this clinical condition, being not observed in healthy controls.
Conclusions
Both clinic and 24-h HR values greater than 70 beats/minute are associated with an increased sympathetic activation, which parallels for magnitude the HR elevations. These findings support the relevance of using in the therapeutic approach to HF drugs exerting sympathomoderating properties.

© 2022. The Author(s).

Clin Res Cardiol: 12 May 2022; epub ahead of print
Grassi G, Seravalle G, Vanoli J, Facchetti R, Spaziani D, Mancia G
Clin Res Cardiol: 12 May 2022; epub ahead of print | PMID: 35552503
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Abstract

Collateral effect of the COVID-19 pandemic on cardiology service provision and cardiovascular mortality in a population-based study: COVID-COR-LT.

Čelutkienė J, Čerlinskaitė-Bajorė K, Bajoras V, Višinskienė R, ... Šerpytis P, Davidavičius G
Background
Collateral damage of the COVID-19 pandemic on cardiovascular health is increasingly studied. This is a population-based study addressing multiple aspects of cardiovascular care during the pandemic in a country of Lithuania, in which pandemic waves were significantly different.
Methods
Data on cardiology outpatient care, hospitalizations and cardiovascular mortality in 2019 and 2020 were collected from Lithuanian nationwide administrative databases and registries. Weekly data and aggregated numbers of corresponding 6-week phases were analyzed comparing the numbers between 2019 and 2020. Age, sex and regional subgroup analysis was performed.
Results
Both cardiovascular outpatient care visits and hospitalizations decreased dramatically in 2020 compared to 2019 with a peak reduction (up to - 60% for both) during the first pandemic wave in spring of 2020. Simultaneously, cardiovascular mortality was much higher in 2020, with a pronounced peak at the end of the year compared to 2019 (up to 46%). The increase was even more staggering when analyzing home deaths, which rose up to 91% by the end of 2020. Notable differences between age groups, regions and sexes were documented.
Conclusion
A profound indirect damage of COVID-19 pandemic on cardiovascular care was observed in this study, with striking decreases in cardiovascular care provision and concurrent increase in cardiovascular mortality, both overall and, even more dramatically, at home.
Trial registration
ClinicalTrials.gov: NCT05021575 (registration date 25-08-2021, retrospectively registered).

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

Clin Res Cardiol: 12 May 2022; epub ahead of print
Čelutkienė J, Čerlinskaitė-Bajorė K, Bajoras V, Višinskienė R, ... Šerpytis P, Davidavičius G
Clin Res Cardiol: 12 May 2022; epub ahead of print | PMID: 35552504
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Abstract

Cerebral oxygen saturation as outcome predictor after transfemoral transcatheter aortic valve implantation.

Seppelt PC, Mas-Peiro S, Van Linden A, Iken S, ... Fichtlscherer S, Vasa-Nicotera M
Background
Cerebral oxygen saturation (ScO2) can be measured non-invasively by near-infrared spectroscopy (NIRS) and correlates with cerebral perfusion. We investigated cerebral saturation during transfemoral transcatheter aortic valve implantation (TAVI) and its impact on outcome.
Methods and results
Cerebral oxygenation was measured continuously by NIRS in 173 analgo-sedated patients during transfemoral TAVI (female 47%, mean age 81 years) with self-expanding (39%) and balloon-expanding valves (61%). We investigated the periprocedural dynamics of cerebral oxygenation. Mean ScO2 at baseline without oxygen supply was 60%. During rapid ventricular pacing, ScO2 dropped significantly (before 64% vs. after 55%, p < 0.001). ScO2 at baseline correlated positively with baseline left-ventricular ejection fraction (0.230, p < 0.006) and hemoglobin (0.327, p < 0.001), and inversely with EuroSCORE-II ( - 0.285, p < 0.001) and length of in-hospital stay ( - 0.229, p < 0.01). Patients with ScO2 < 56% despite oxygen supply at baseline had impaired 1 year survival (log-rank test p < 0.01) and prolonged in-hospital stay (p = 0.03). Furthermore, baseline ScO2 was found to be a predictor for 1 year survival independent of age and sex (multivariable adjusted Cox regression, p = 0.020, hazard ratio (HR 0.94, 95% CI 0.90-0.99) and independent of overall perioperative risk estimated by EuroSCORE-II and hemoglobin (p = 0.03, HR 0.95, 95% CI 0.91-0.99).
Conclusions
Low baseline ScO2 not responding to oxygen supply might act as a surrogate for impaired cardiopulmonary function and is associated with worse 1 year survival and prolonged in-hospital stay after transfemoral TAVI. ScO2 monitoring is an easy to implement diagnostic tool to screen patients at risk with a potential preserved recovery and worse outcome after TAVI.

© 2022. The Author(s).

Clin Res Cardiol: 04 May 2022; epub ahead of print
Seppelt PC, Mas-Peiro S, Van Linden A, Iken S, ... Fichtlscherer S, Vasa-Nicotera M
Clin Res Cardiol: 04 May 2022; epub ahead of print | PMID: 35505123
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Abstract

Catheter ablation of supraventricular tachycardia in patients with and without structural heart disease: insights from the German ablation registry.

Eitel C, Ince H, Brachmann J, Kuck KH, ... Senges J, Tilz RR
Aim
To compare patient characteristics, safety and efficacy of catheter ablation of supraventricular tachycardia (SVT) in patients with and without structural heart disease (SHD) enrolled in the German ablation registry.
Methods and results
From January 2007 until January 2010, a total of 12,536 patients (37.2% with known SHD) were enrolled and followed for at least one year. Patients with SHD more often underwent ablation for atrial flutter (45.8% vs. 20.9%, p < 0.001), whereas patients without SHD more often underwent ablation for atrioventricular nodal reentrant tachycardia (30.2% vs. 11.8%, p < 0.001) or atrioventricular reentrant tachycardia (9.1% vs. 1.6%, p < 0.001). Atrial fibrillation catheter ablation procedures were performed in a similar proportion of patients with and without SHD (38.1% vs. 36.9%, p = 0.21). Overall, periprocedural success rate was high in both groups. Death, myocardial infarction or stroke occurred in 0.2% and 0.1% of patients with and without SHD (p = 0.066). Major non-fatal complications prior to discharge were rare and did not differ significantly between patients with and without SHD (0.5% vs. 0.4%, p = 0.34). Kaplan-Meier mortality estimate at 1 year demonstrated a significant mortality increase in patients with SHD (2.6% versus 0.7%; p < 0.001).
Conclusion
Patients with and without SHD undergoing SVT ablation exhibit similar success rates and low major complication rates, despite disadvantageous baseline characteristics in SHD patients. These data highlight the safety and efficacy of SVT ablation in patients with and without SHD. Nevertheless Kaplan-Meier mortality estimates at 1 year demonstrate a significant mortality increase in patients with SHD, highlighting the importance of treating the underlying condition and reliable anticoagulation if indicated.

© 2021. The Author(s).

Clin Res Cardiol: 01 May 2022; 111:522-529
Eitel C, Ince H, Brachmann J, Kuck KH, ... Senges J, Tilz RR
Clin Res Cardiol: 01 May 2022; 111:522-529 | PMID: 34106323
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Abstract

Catheter ablation of short-coupled variant of torsade de pointes.

Steinfurt J, Nazer B, Aguilar M, Moss J, ... Tedrow UB, Bogossian H
Background
The short-coupled variant of torsade de pointes (sc-TdP) is a malignant arrhythmia that frequently presents with ventricular fibrillation (VF) electrical storm. Verapamil is considered the first-line therapy of sc-TdP while catheter ablation is not widely adopted. The aim of this study was to determine the origin of sc-TdP and to assess the outcome of catheter ablation using 3D-mapping.
Methods and results
We retrospectively analyzed five patients with sc-TdP who underwent 3D-mapping and ablation of sc-TdP at five different institutions. Four patients initially presented with sudden cardiac arrest, one patient experienced recurrent syncope as the first manifestation. All patients demonstrated a monomorphic premature ventricular contraction (PVC) with late transition left bundle branch block pattern, superior axis, and a coupling interval of less than 300 ms. triggering recurrent TdP and VF. In four patients, the culprit PVC was mapped to the free wall insertion of the moderator band (MB) with a preceding Purkinje potential in two patients. Catheter ablation using 3D-mapping and intracardiac echocardiography eliminated sc-TdP in all patients, with no recurrence at mean 2.7 years (range 6 months to 8 years) of follow-up.
Conclusion
3D-mapping and intracardiac echocardiography demonstrate that sc-TdP predominantly originates from the MB free wall insertion and its Purkinje network. Catheter ablation of the culprit PVC at the MB free wall junction leads to excellent short- and long-term results and should be considered as first-line therapy in recurrent sc-TdP or electrical storm.

© 2021. The Author(s).

Clin Res Cardiol: 01 May 2022; 111:502-510
Steinfurt J, Nazer B, Aguilar M, Moss J, ... Tedrow UB, Bogossian H
Clin Res Cardiol: 01 May 2022; 111:502-510 | PMID: 33770204
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Abstract

Is there a benefit of ICD treatment in patients with persistent severely reduced systolic left ventricular function after TAVI?

Nies RJ, Frerker C, Adam M, Kuhn E, ... Baldus S, Schmidt T
Background
In patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) and heart failure with severely reduced ejection fraction, prediction of postprocedural left ventricular ejection fraction (LVEF) improvement is challenging. Decision-making and timing for implantable cardioverter defibrillator (ICD) treatment are difficult and benefit is still unclear in this patient population.
Objective

Aims:
of the study were to analyse long-term overall mortality in TAVI-patients with a preprocedural LVEF ≤ 35% regarding LVEF improvement and effect of ICD therapy.
Methods and results
Retrospective analysis of a high-risk TAVI-population suffering from severe AS and heart failure with a LVEF ≤ 35%. Out of 1485 TAVI-patients treated at this center between January 2013 and April 2018, 120 patients revealed a preprocedural LVEF ≤ 35% and had sufficient follow-up. 36.7% (44/120) of the patients suffered from persistent reduced LVEF without a postprocedural increase above 35% within 1 year after TAVI or before death, respectively. Overall mortality was neither significantly reduced by LVEF recovery above 35% (p = 0.31) nor by additional ICD treatment in patients with persistent LVEF ≤ 35% (p = 0.33).
Conclusion
In high-risk TAVI-patients suffering from heart failure with LVEF ≤ 35%, LVEF improvement to more than 35% did not reduce overall mortality. Patients with postprocedural persistent LVEF reduction did not seem to benefit from ICD treatment. Effects of LVEF improvement and ICD treatment on mortality are masked by the competing risk of death from relevant comorbidities.

© 2021. The Author(s).

Clin Res Cardiol: 01 May 2022; 111:492-501
Nies RJ, Frerker C, Adam M, Kuhn E, ... Baldus S, Schmidt T
Clin Res Cardiol: 01 May 2022; 111:492-501 | PMID: 33758967
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Impact:
Abstract

Impact of early ablation of atrial fibrillation on long-term outcomes: results from phase II/III of the GLORIA-AF registry.

Ding WY, Calvert P, Gupta D, Huisman MV, Lip GYH, GLORIA-AF Investigators
Background
First-line ablation for atrial fibrillation (AF) reduces the risk of recurrent atrial arrhythmias compared to medical therapy. However, the prognostic benefit of early AF ablation remains undetermined. Herein, we aimed to evaluate the effects of early AF ablation compared to medical therapy.
Methods
Using data from phase II/III of the GLORIA-AF registry, we studied patients who were consecutively enrolled with newly diagnosed AF (< 3 months before baseline visit) and an increased risk of stroke (CHA2DS2-VASc ≥ 1). At baseline visit, 445 (1.7%) patients were treated with early AF ablation and 25,518 (98.3%) with medical therapy. Outcomes of interest were the composite outcome of all-cause death, stroke and major bleeding, and pre-specified outcomes of all-cause death, cardiovascular (CV) death, non-CV death, stroke and major bleeding.
Results
A total of 25,963 patients (11733 [45.2%] females; median age 71 [IQR 64-78] years; 17424 [67.1%] taking non-vitamin K antagonist oral anticoagulants [NOACs]) were included. Over a follow-up period of 3.0 (IQR 2.3-3.1) years, after adjustment for confounders, early AF ablation was associated with a significant reduction in the composite outcome of all-cause death, stroke and major bleeding (HR 0.50 [95% CI 0.30-0.85]) and all-cause death (HR 0.45 [95% CI 0.23-0.91]). There were no statistical differences between the groups in terms of CV death, non-CV death, stroke and major bleeding. Similar results were obtained in a propensity-score matched analysis of patients with comparable baseline variables.
Conclusions
Early AF ablation in a contemporary prospective cohort of AF patients who were predominantly treated with NOACs was associated with a survival advantage compared to medical therapy alone.
Trial registration
Clinical trial registration: http://www.
Clinicaltrials
gov . Unique identifiers: NCT01468701, NCT01671007 and NCT01937377. Created with BioRender.com.

© 2022. The Author(s).

Clin Res Cardiol: 29 Apr 2022; epub ahead of print
Ding WY, Calvert P, Gupta D, Huisman MV, Lip GYH, GLORIA-AF Investigators
Clin Res Cardiol: 29 Apr 2022; epub ahead of print | PMID: 35488127
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Abstract

Rotational atherectomy of calcified coronary lesions: current practice and insights from two randomized trials.

Allali A, Abdel-Wahab M, Elbasha K, Mankerious N, ... Toelg R, Richardt G
With growing experience, technical improvements and use of newer generation drug-eluting stents (DES), recent data showed satisfactory acute and long-term results after rotational atherectomy (RA) in calcified coronary lesions. The randomized ROTAXUS and PREPARE-CALC trials compared RA to balloon-based strategies in two different time periods in the DES era. In this manuscript, we assessed the technical evolution in RA practice from a pooled analysis of the RA groups of both trials and established a link to further recent literature. Furthermore, we sought to summarize and analyze the available experience with RA in different patient and lesion subsets, and propose recommendations to improve RA practice. We also illustrated the combination of RA with other methods of lesion preparation. Finally, based on the available evidence, we propose a simple and practical approach to treat severely calcified lesions.

© 2022. The Author(s).

Clin Res Cardiol: 28 Apr 2022; epub ahead of print
Allali A, Abdel-Wahab M, Elbasha K, Mankerious N, ... Toelg R, Richardt G
Clin Res Cardiol: 28 Apr 2022; epub ahead of print | PMID: 35482101
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Impact:
Abstract

Periprocedural myocardial injury according to optical characteristics of neointima and treatment modality of in-stent restenosis.

Nano N, Aytekin A, Ndrepepa G, Seguchi M, ... Kastrati A, Xhepa E
Aims
Aim of the present study was to investigate the impact of increasing neointimal inhomogeneity and neoatherosclerosis as well as of treatment modality of in-stent restenosis (ISR) on the occurrence of periprocedural myocardial injury (PMI).
Methods and results
Patients with normal or stable/falling increased baseline high-sensitivity troponin T (hs-cTnT) undergoing intravascular optical coherence tomography (OCT) and subsequent percutaneous coronary intervention (PCI) of ISR by means of drug-coated balloon (DCB) or drug-eluting stent (DES) were included. Overall, 128 patients were subdivided into low (n = 64) and high (n = 64) inhomogeneity groups, based on the median of distribution of non-homogeneous quadrants. No significant between-group differences were detected in terms of hs-cTnT changes (28.0 [12.0-65.8] vs. 25.5 [9.8-65.0] ng/L; p = 0.355), or the incidence of major PMI (31.2 vs. 31.2%; p = 1.000). Similarly, no differences were observed between DCB- and DES-treated groups in terms of hs-cTn changes (27.0 [10.0-64.0] vs. 28.0 [11.0-73.0] ng/L; p = 0.795), or the incidence of major PMI (28.9 vs. 35.6%; p = 0.566). Additionally, no significant interaction was present between optical neointimal characteristics and treatment modality in terms of changes in hs-cTnT (Pint = 0.432). No significant differences in PMI occurrence were observed between low and high neoatherosclerosis subgroups.
Conclusions
In patients undergoing PCI for ISR, there was no association between increasing neointimal inhomogeneity, or increasing expression of neoatherosclerotic changes and occurrence of PMI. PMI occurrence was not influenced by the treatment modality (DCB vs. DES) of ISR lesions, a finding that supports the safety of DCB treatment for ISR.

© 2022. The Author(s).

Clin Res Cardiol: 27 Apr 2022; epub ahead of print
Nano N, Aytekin A, Ndrepepa G, Seguchi M, ... Kastrati A, Xhepa E
Clin Res Cardiol: 27 Apr 2022; epub ahead of print | PMID: 35476138
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Impact:
Abstract

Analysis of YouTube videos as a source of information for myocarditis during the COVID-19 pandemic.

Memioglu T, Ozyasar M
Objective
In this study, we aimed to examine the content, reliability, and quality of YouTube video contents concerning myocarditis and its association with the COVID-19 for the first time in the literature.
Methods
The most viewed 50 videos were included in the analysis. The time since the videos were uploaded, video length, type of image (real/animation), video content, qualify of the uploaders, the number of daily and total views, likes, dislikes, comments and VPI were recorded. The reliability of the videos was determined using the modified DISCERN criteria for consumer health information, while the quality was determined with the GQS.
Results
The mean length of the videos was found as 6.25 ± 5.20 min. Contents of the videos included general information, COVID-19, vaccination, diagnosis, patient experience and treatment. The most common contents were regarding COVID-19 and vaccination by 44%. The uploaders of the videos were classified as physicians, hospital channels, health channels, patients and others. Fourteen (28%) videos were directly uploaded by physicians. The most viewed, liked and disliked videos were uploaded by health channels. The mean VPI score was calculated as 92.89 ± 12.29. The mean DISCERN score of all videos was 3.88 ± 0.77 and the mean GQS score was 3.63 ± 0.85. Reliability and quality of the videos were moderate.
Conclusion
YouTube videos on myocarditis have mostly focused on the associations between myocarditis and COVID-19 disease and vaccination. Health-related contents on YouTube should be subjected to peer review and quality assessment.

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

Clin Res Cardiol: 26 Apr 2022; epub ahead of print
Memioglu T, Ozyasar M
Clin Res Cardiol: 26 Apr 2022; epub ahead of print | PMID: 35471259
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Abstract

Efficacy and safety of catheter ablation for Brugada syndrome: an updated systematic review.

Kotake Y, Barua S, Kazi S, Virk S, ... Bennett RG, Kumar S
Background
Patients with Brugada syndrome (BrS) may experience recurrent ventricular arrhythmias (VAs). Catheter ablation is becoming an emerging paradigm for treatment of BrS.
Objective
To assess the efficacy and safety of catheter ablation in BrS in an updated systematic review.
Methods
We comprehensively searched the databases of Pubmed/Medline, EMBASE, and Cochrane Central Register of Controlled Trials from inception to 11th of August 2021.
Results
Fifty-six studies involving 388 patients were included. A substrate-based strategy was used in 338 cases (87%), and a strategy of targeting premature ventricular complex (PVCs)/ventricular tachycardias (VTs) that triggered ventricular fibrillation (VF) in 47 cases (12%), with combined abnormal electrogram and PVC/VT ablation in 3 cases (1%). Sodium channel blocker was frequently used to augment the arrhythmogenic substrate in 309/388 cases (80%), which included a variety of agents, of which ajmaline was most commonly used. After ablation procedure, the pooled incidence of non-inducibility of VA was 87.1% (95% confidence interval [CI], 73.4-94.3; I2 = 51%), and acute resolution of type I ECG was seen in 74.5% (95% CI [52.3-88.6]; I2 = 75%). Over a weighted mean follow up of 28 months, 7.6% (95% CI [2.1-24]; I2 = 67%) had recurrence of type I ECG either spontaneously or with drug challenge and 17.6% (95% CI [10.2-28.6]; I2 = 60%) had recurrence of VA.
Conclusion
Catheter ablation appears to be an efficacious strategy for elimination of arrhythmias or substrate associated with BrS. Further study is needed to identify which patients stand to benefit, and optimal provocation protocol for identifying ablation targets.

© 2022. Crown.

Clin Res Cardiol: 22 Apr 2022; epub ahead of print
Kotake Y, Barua S, Kazi S, Virk S, ... Bennett RG, Kumar S
Clin Res Cardiol: 22 Apr 2022; epub ahead of print | PMID: 35451610
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Impact:
Abstract

Decreases in hepatokine Fetuin-A levels are associated with hepatic hypoperfusion and predict cardiac outcomes in patients with heart failure.

Tomita Y, Misaka T, Yoshihisa A, Ichijo Y, ... Kobayashi A, Takeishi Y
Background
Interactions of the heart and the liver remain to be fully understood in the pathophysiology of heart failure (HF). Hepatokines are proteins synthesized and secreted from the liver and regulate systemic metabolisms of peripheral tissues. This study sought to clarify the clinical relevance of hepatokine Fetuin-A in patients with HF.
Methods and results
We enrolled 217 participants including 187 hospitalized patients with HF and 30 control subjects who were sought with a comparable age- and sex profile and who had never had HF or structural cardiac abnormalities. First, we examined the levels of Fetuin-A and found that its levels were significantly lower in patients with HF than in the controls. Next, HF patients were categorized into four groups based on hepatic hemodynamics assessed by abdominal ultrasonography which determines liver hypoperfusion by peak systolic velocity (PSV) of the celiac artery and liver stiffness by shear wave elastography (SWE). Fetuin-A levels were significantly decreased in HF patients with liver hypoperfusion compared to those without, but were not different between HF patients with and without elevated liver stiffness. Correlation analysis revealed that circulating Fetuin-A was positively correlated with PSV of the celiac artery but not with SWE of the liver. Kaplan-Meier analysis demonstrated that HF patients with lower Fetuin-A levels were significantly associated with increased adverse outcomes including cardiac deaths and decompensated HF.
Conclusions
Liver-derived hepatokine Fetuin-A may be a novel target involved in the cardio-hepatic interactions, as well as a useful biomarker for predicting the prognosis in patients with HF.

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

Clin Res Cardiol: 19 Apr 2022; epub ahead of print
Tomita Y, Misaka T, Yoshihisa A, Ichijo Y, ... Kobayashi A, Takeishi Y
Clin Res Cardiol: 19 Apr 2022; epub ahead of print | PMID: 35438339
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Impact:
Abstract

Symptom burden, psychosocial distress and palliative care needs in heart failure - A cross-sectional explorative pilot study.

Strangl F, Ischanow E, Ullrich A, Oechsle K, ... Kirchhof P, Rybczynski M
Background
Beyond guideline-directed treatments aimed at improving cardiac function and prognosis in heart failure (HF), patient-reported outcomes have gained attention.
Purpose
Using a cross-sectional approach, we assessed symptom burden, psychosocial distress, and potential palliative care (PC) needs in patients with advanced stages of HF.
Methods
At a large tertiary care center, we enrolled HF patients in an exploratory pilot study. Symptom burden and psychosocial distress were assessed using the MIDOS (Minimal Documentation System for Patients in PC) questionnaire and the Distress Thermometer (DT), respectively. The 4-item Patient Health Questionnaire (PHQ-4) was used to screen for anxiety and depression. To assess PC needs, physicians used the \"Palliative Care Screening Tool for HF Patients\".
Results
We included 259 patients, of whom 137 (53%) were enrolled at the Heart Failure Unit (HFU), and 122 (47%) at the outpatient clinic (OC). Mean age was 63 years, 72% were male. New York Heart Association class III or IV symptoms were present in 56%. With a mean 5-year survival 64% (HFU) vs. 69% (OC) calculated by the Seattle Heart Failure Model, estimated prognosis was comparatively good. Symptom burden (MIDOS score 8.0 vs. 5.4, max. 30 points, p < 0.001) and level of distress (DT score 6.0 vs. 4.8, max. 10 points, p < 0.001) were higher in hospitalised patients. Clinically relevant distress was detected in the majority of patients (HFU 76% vs. OC 57%, p = 0.001), and more than one third exhibited at least mild symptoms of depression or anxiety. Screening for PC needs revealed 82% of in- and 52% of outpatients fulfil criteria for specialized palliative support.
Conclusion
Despite a good prognosis, we found multiple undetected and unaddressed needs in an advanced HF cohort. This study\'s tools and screening results may help to early explore these needs, to further improve integrated HF care.

© 2022. The Author(s).

Clin Res Cardiol: 14 Apr 2022; epub ahead of print
Strangl F, Ischanow E, Ullrich A, Oechsle K, ... Kirchhof P, Rybczynski M
Clin Res Cardiol: 14 Apr 2022; epub ahead of print | PMID: 35420358
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Impact:
Abstract

Association of pulmonary vein isolation and major cardiovascular events in patients with atrial fibrillation.

Girod M, Coslovsky M, Aeschbacher S, Sticherling C, ... Osswald S, Kühne M
Background
Patients with atrial fibrillation (AF) face an increased risk of adverse cardiovascular events. Evidence suggests that early rhythm control including AF ablation may reduce this risk.
Methods
To compare the risks for cardiovascular events in AF patients with and without pulmonary vein isolation (PVI), we analysed data from two prospective cohort studies in Switzerland (n = 3968). A total of 325 patients who had undergone PVI during a 1-year observational period were assigned to the PVI group. Using coarsened exact matching, 2193 patients were assigned to the non-PVI group. Outcomes were all-cause mortality, hospital admission for acute heart failure, a composite of stroke, transient ischemic attack and systemic embolism (Stroke/TIA/SE), myocardial infarction (MI), and bleedings. We calculated multivariable adjusted Cox proportional-hazards models.
Results
Overall, 2518 patients were included, median age was 66 years [IQR 61.0, 71.0], 25.8% were female. After a median follow-up time of 3.9 years, fewer patients in the PVI group died from any cause (incidence per 100 patient-years 0.64 versus 1.87, HR 0.39, 95%CI 0.19-0.79, p = 0.009) or were admitted to hospital for acute heart failure (incidence per 100 patient-years 0.52 versus 1.72, HR 0.44, 95%CI 0.21-0.95, p = 0.035). There was no significant association between PVI and Stroke/TIA/SE (HR 0.94, 95%CI 0.52-1.69, p = 0.80), MI (HR 0.43, 95%CI 0.11-1.63, p = 0.20) or bleeding (HR 0.75, 95% CI 0.50-1.12, p = 0.20).
Conclusions
In our matched comparison, patients in the PVI group had a lower incidence rate of all-cause mortality and hospital admission for acute heart failure compared to the non-PVI group.
Clinicaltrials

Gov identifier
NCT02105844, April 7th 2014.

© 2022. The Author(s).

Clin Res Cardiol: 11 Apr 2022; epub ahead of print
Girod M, Coslovsky M, Aeschbacher S, Sticherling C, ... Osswald S, Kühne M
Clin Res Cardiol: 11 Apr 2022; epub ahead of print | PMID: 35403852
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Impact:
Abstract

Clinical cardiovascular phenotypes and the pattern of future events in patients with type 2 diabetes.

Malik ME, Andersson C, Blanche P, D\'Souza M, ... Gislason G, Schou M
Importance
Updated guidelines on diabetes recommend targeting sodium-glucose cotransporter-2 inhibitors (SGLT2i) at patients at risk of heart failure (HF) and glucagon-like peptide-1 receptor agonists (GLP1-RA) at those at greater risk of atherothrombotic events.
Objective
We estimated the risk of different cardiovascular events in patients with type 2 diabetes (T2D) and newly established cardiovascular disease.
Design, setting and participants
Patients with T2D and newly established cardiovascular disease from 1998 to 2016 were identified using Danish healthcare registers and divided into one of four phenotype groups: (1) HF, (2) ischemic heart disease (IHD), (3) transient ischemic stroke (TIA)/ischemic stroke, and (4) peripheral artery disease (PAD). The absolute 5-year risk of the first HF- or atherothrombotic event occurring after inclusion was calculated, along with the risk of death.
Main outcomes and measures
The main outcome was the first event of either HF or an atherothrombotic event (IHD, TIA/ischemic stroke or PAD) in patients with T2D and  new-onset cardiovascular disease.
Results
Of the 37,850 patients included, 40% were female and the median age was 70 years. Patients with HF were at higher 5-year risk of a subsequent HF event (17.9%; 95% confidence interval (CI) 17.1-18.8%) than an atherothrombotic event (15.8%; 15.0-16.6%). Patients with IHD were at higher risk of a subsequent atherothrombotic event (24.6%; 23.9-25.3%) than developing HF, although the risk of HF was still substantial (10.6%; 10.2-11.1%). Conversely, patients with PAD were at low risk of developing HF (4.4%; 3.8-5.1%) but at high risk of developing an atherothrombotic event (15.9%; 14.9-17.1%). Patients with TIA/ischemic stroke had the lowest risk of HF (3.2%; 2.9-3.6%) and the highest risk of an atherothrombotic event (20.6%; 19.8-21.4).
Conclusions
In T2D, a patient\'s cardiovascular phenotype can help predict the pattern of future cardiovascular events.

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

Clin Res Cardiol: 08 Apr 2022; epub ahead of print
Malik ME, Andersson C, Blanche P, D'Souza M, ... Gislason G, Schou M
Clin Res Cardiol: 08 Apr 2022; epub ahead of print | PMID: 35396632
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Impact:
Abstract

The effects of positive end-expiratory pressure on cardiac function: a comparative echocardiography-conductance catheter study.

Berger D, Wigger O, de Marchi S, Grübler MR, ... Bachmann KF, Bloechlinger S
Background
Echocardiographic parameters of diastolic function depend on cardiac loading conditions, which are altered by positive pressure ventilation. The direct effects of positive end-expiratory pressure (PEEP) on cardiac diastolic function are unknown.
Methods
Twenty-five patients without apparent diastolic dysfunction undergoing coronary angiography were ventilated noninvasively at PEEPs of 0, 5, and 10 cmH2O (in randomized order). Echocardiographic diastolic assessment and pressure-volume-loop analysis from conductance catheters were compared. The time constant for pressure decay (τ) was modeled with exponential decay. End-diastolic and end-systolic pressure volume relationships (EDPVRs and ESPVRs, respectively) from temporary caval occlusion were analyzed with generalized linear mixed-effects and linear mixed models. Transmural pressures were calculated using esophageal balloons.
Results
τ values for intracavitary cardiac pressure increased with the PEEP (n = 25; no PEEP, 44 ± 5 ms; 5 cmH2O PEEP, 46 ± 6 ms; 10 cmH2O PEEP, 45 ± 6 ms; p < 0.001). This increase disappeared when corrected for transmural pressure and diastole length. The transmural EDPVR was unaffected by PEEP. The ESPVR increased slightly with PEEP. Echocardiographic mitral inflow parameters and tissue Doppler values decreased with PEEP [peak E wave (n = 25): no PEEP, 0.76 ± 0.13 m/s; 5 cmH2O PEEP, 0.74 ± 0.14 m/s; 10 cmH2O PEEP, 0.68 ± 0.13 m/s; p = 0.016; peak A wave (n = 24): no PEEP, 0.74 ± 0.12 m/s; 5 cmH2O PEEP, 0.7 ± 0.11 m/s; 10 cmH2O PEEP, 0.67 ± 0.15 m/s; p = 0.014; E\' septal (n = 24): no PEEP, 0.085 ± 0.016 m/s; 5 cmH2O PEEP, 0.08 ± 0.013 m/s; 10 cmH2O PEEP, 0.075 ± 0.012 m/s; p = 0.002].
Conclusions
PEEP does not affect active diastolic relaxation or passive ventricular filling properties. Dynamic echocardiographic filling parameters may reflect changing loading conditions rather than intrinsic diastolic function. PEEP may have slight positive inotropic effects.
Clinical trial registration
https://clinicaltrials.gov/ct2/show/NCT02267291 , registered 17. October 2014.

© 2022. The Author(s).

Clin Res Cardiol: 06 Apr 2022; epub ahead of print
Berger D, Wigger O, de Marchi S, Grübler MR, ... Bachmann KF, Bloechlinger S
Clin Res Cardiol: 06 Apr 2022; epub ahead of print | PMID: 35381904
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Impact:
Abstract

Transcatheter-based aortic valve replacement vs. isolated surgical aortic valve replacement in 2020.

Gaede L, Blumenstein J, Eckel C, Grothusen C, ... Achenbach S, Möllmann H
Background
Based on the results of several recent randomized trials, European and American guidelines on valvular heart disease management have substantially expanded the indications for transcatheter aortic valve implantation (TAVI). We present an all-comer data on peri-operative risk profile and in-hospital outcomes from Germany for patients treated by TAVI or isolated surgical aortic valve replacement (iSAVR) in 2020, providing an opportunity to compare study data with data from daily clinical practice.
Methods
Data concerning all isolated aortic valve procedures performed in Germany in 2020 were retrieved from the mandatory nationwide quality control program. Expected mortality was calculated with the annually revised German Aortic valve score (AKL-score) based on the data of either catheter-based (AKL-CATH) or isolated surgical (AKL-CHIR) aortic valve replacement in Germany from the previous year (2019).
Results
In 2020 21,903 TAVI procedures (20,810 transvascular (TV; vs. 2019: 22.973; - 9.4%), 1093 transapical (TA; vs. 2019: 1413; - 22.6%)) and 6144 (vs. 2019 7905; - 22.5%) iSAVR were performed in Germany. Patients who received TAVI showed a significantly higher perioperative risk profile than patients undergoing iSAVR based on older age and more severe co-morbidities. While in-hospital mortality after TAVI (2.3%) was numerically lower than in 2019 (2.5%), this difference was not significant (p = 0.11). In-hospital mortality after iSAVR was identical in 2020 and 2019 (2.8%) and thus higher than after TAVI (p = 0.003), resulting in an observed expected mortality ratio of 1.02 after TAVI and 1.05 after iSAVR. After exclusion of the emergency procedures, in-hospital mortality did not differ significantly between the groups (TAVI 2.2% vs. iSAVR 1.9%, p = 0.26).
Conclusion
Total numbers of both iSAVR and TAVI in Germany were lower in 2020 than in 2019, most likely due to the COVID-19 pandemic. However, the relative number of patients treated by TAVI as compared to iSAVR continues to increase. Despite older age and more severe comorbidities compared to patients undergoing iSAVR the in-hospital mortality after TAVI continued to decrease in 2020 and remains significantly lower than after iSAVR.

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

Clin Res Cardiol: 01 Apr 2022; epub ahead of print
Gaede L, Blumenstein J, Eckel C, Grothusen C, ... Achenbach S, Möllmann H
Clin Res Cardiol: 01 Apr 2022; epub ahead of print | PMID: 35362737
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Impact:
Abstract

Serum sodium and eplerenone use in patients with a myocardial infarction and left ventricular dysfunction or heart failure: insights from the EPHESUS trial.

Martens P, Ferreira JP, Vincent J, Abreu P, ... Zannad F, Rossignol P
Background
Sodium changes are common in myocardial infarction (MI) complicated with left ventricular systolic dysfunction (LVSD) and/or heart failure (HF). Sodium handling is fine-tuned in the distal nephron, were eplerenone exhibits some of its pleotropic effects. Little is known about the effect of eplerenone on serum sodium and the prognostic relevance of sodium alterations in patients with MI complicated with LVSD and/or HF.
Methods
The EPHESUS trial randomized 6632 patients to either eplerenone or placebo. Hyponatremia and hypernatremia were defined as sodium < 135 mmol/L or > 145 mmol/L, respectively. Linear mixed models and time updated Cox regression analysis were used to determine the effect of eplerenone on sodium changes and the prognostic importance of sodium changes, respectively. The primary outcomes were all-cause mortality and a composite of cardiovascular (CV) mortality and CV-hospitalization.
Results
A total of 6221 patients had a post-baseline sodium measurement, 797 patients developed hyponatremia (mean of 0.2 events/per patient) and 1476 developed hypernatremia (mean of 0.4 events/per patient). Patients assigned to eplerenone had a lower mean serum sodium over the follow-up (140 vs 141 mmol/L; p < 0.0001) and more often developed hyponatremia episodes (15 vs 11% p = 0.0001) and less often hypernatremia episodes (22 vs. 26% p = 0.0003). Hyponatremia, but not hypernatremia was associated with adverse outcome for all outcome endpoints in the placebo group but not in the eplerenone group (interaction p value < 0.05 for all). Baseline sodium values did not influence the treatment effect of eplerenone in reducing the various endpoints (interaction p value > 0.05 for all). Development of new-onset hyponatremia following eplerenone initiation did not diminish the beneficial eplerenone treatment effect.
Conclusion
Eplerenone induces minor reductions in serum sodium. The beneficial effect of eplerenone was maintained regardless of the baseline serum sodium or the development of hyponatremia. Sodium alterations should not refrain clinicians from prescribing eplerenone to patients who had an MI complicated with LVSD and/or HF.
Trail registry
ClinicalTrials.gov identifier: NCT00232180. Serum sodium and eplerenone use in patients with a myocardial infarction and left ventricular dysfunction or heart failure: insights from the EPHESUS trial.

© 2021. Springer-Verlag GmbH Germany, part of Springer Nature.

Clin Res Cardiol: 01 Apr 2022; 111:380-392
Martens P, Ferreira JP, Vincent J, Abreu P, ... Zannad F, Rossignol P
Clin Res Cardiol: 01 Apr 2022; 111:380-392 | PMID: 33893561
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Impact:
Abstract

Native T1 mapping for the diagnosis of cardiac amyloidosis in patients with left ventricular hypertrophy.

Lavall D, Vosshage NH, Geßner R, Stöbe S, ... Hagendorff A, Laufs U
Background
Cardiac magnetic resonance (CMR) with parametric mapping can improve the characterization of myocardial tissue. We studied the diagnostic value of native T1 mapping to detect cardiac amyloidosis in patients with left ventricular (LV) hypertrophy.
Methods
One hundred twenty-five patients with increased LV wall thickness (≥ 12 mm end-diastole) who received clinical CMR in a 3 T scanner between 2017 and 2020 were included. 31 subjects without structural heart disease served as controls. Native T1 was measured as global mean value from 3 LV short axis slices. The study was registered at German clinical trial registry (DRKS00022048).
Results
Mean age of the patients was 66 ± 14 years, 83% were males. CA was present in 24 patients, 21 patients had hypertrophic cardiomyopathy (HCM), 80 patients suffered from hypertensive heart disease (HHD). Native T1 times were higher in patients with CA (1409 ± 59 ms, p < 0.0001) compared to healthy controls (1225 ± 21 ms), HCM (1266 ± 44 ms) and HHD (1257 ± 41 ms). HCM and HHD patients did not differ in their native T1 times but were increased compared to control (p < 0.01). ROC analysis of native T1 demonstrated an area under the curve for the detection of CA vs. HCM and HHD of 0.9938 (p < 0.0001), which was higher than that of extracellular volume (0.9876) or quantitative late gadolinium enhancement (0.9406; both p < 0.0001). The optimal cut-off value of native T1 to diagnose CA was 1341 ms (sensitivity 100%, specificity 97%).
Conclusion
Non-contrast CMR imaging with native T1 mapping provides high diagnostic accuracy to diagnose cardiac amyloidosis in patients with left ventricular hypertrophy.

© 2022. The Author(s).

Clin Res Cardiol: 31 Mar 2022; epub ahead of print
Lavall D, Vosshage NH, Geßner R, Stöbe S, ... Hagendorff A, Laufs U
Clin Res Cardiol: 31 Mar 2022; epub ahead of print | PMID: 35355115
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Impact:
Abstract

Machine learning in the detection and management of atrial fibrillation.

Wegner FK, Plagwitz L, Doldi F, Ellermann C, ... Varghese J, Eckardt L
Machine learning has immense novel but also disruptive potential for medicine. Numerous applications have already been suggested and evaluated concerning cardiovascular diseases. One important aspect is the detection and management of potentially thrombogenic arrhythmias such as atrial fibrillation. While atrial fibrillation is the most common arrhythmia with a lifetime risk of one in three persons and an increased risk of thromboembolic complications such as stroke, many atrial fibrillation episodes are asymptomatic and a first diagnosis is oftentimes only reached after an embolic event. Therefore, screening for atrial fibrillation represents an important part of clinical practice. Novel technologies such as machine learning have the potential to substantially improve patient care and clinical outcomes. Additionally, machine learning applications may aid cardiologists in the management of patients with already diagnosed atrial fibrillation, for example, by identifying patients at a high risk of recurrence after catheter ablation. We summarize the current state of evidence concerning machine learning and, in particular, artificial neural networks in the detection and management of atrial fibrillation and describe possible future areas of development as well as pitfalls. Typical data flow in machine learning applications for atrial fibrillation detection.

© 2022. The Author(s).

Clin Res Cardiol: 30 Mar 2022; epub ahead of print
Wegner FK, Plagwitz L, Doldi F, Ellermann C, ... Varghese J, Eckardt L
Clin Res Cardiol: 30 Mar 2022; epub ahead of print | PMID: 35353207
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Impact:
Abstract

Comparisons of the risk of myopericarditis between COVID-19 patients and individuals receiving COVID-19 vaccines: a population-based study.

Chou OHI, Zhou J, Lee TTL, Kot T, ... Cheung BMY, Tse G
Background
Both COVID-19 infection and COVID-19 vaccines have been associated with the development of myopericarditis. The objective of this study is to (1) analyse the rates of myopericarditis after COVID-19 infection and COVID-19 vaccination in Hong Kong, (2) compared to the background rates, and (3) compare the rates of myopericarditis after COVID-19 vaccination to those reported in other countries.
Methods
This was a population-based cohort study from Hong Kong, China. Patients with positive RT-PCR test for COVID-19 between 1st January 2020 and 30th June 2021 or individuals who received COVID-19 vaccination until 31st August were included. The main exposures were COVID-19 positivity or COVID-19 vaccination. The primary outcome was myopericarditis.
Results
This study included 11,441 COVID-19 patients from Hong Kong, four of whom suffered from myopericarditis (rate per million: 326; 95% confidence interval [CI] 127-838). The rate was higher than the pre-COVID-19 background rate in 2019 (rate per million: 5.5, 95% CI 4.1-7.4) with a rate ratio of 55.0 (95% CI 21.4-141). Compared to the background rate, the rate of myopericarditis among vaccinated subjects in Hong Kong was similar (rate per million: 5.5; 95% CI 4.1-7.4) with a rate ratio of 0.93 (95% CI 0.69-1.26). The rates of myocarditis after vaccination in Hong Kong were comparable to those vaccinated in the United States, Israel, and the United Kingdom.
Conclusions
COVID-19 infection was associated with significantly higher rate of myopericarditis compared to the vaccine-associated myopericarditis.

© 2022. The Author(s).

Clin Res Cardiol: 25 Mar 2022; epub ahead of print
Chou OHI, Zhou J, Lee TTL, Kot T, ... Cheung BMY, Tse G
Clin Res Cardiol: 25 Mar 2022; epub ahead of print | PMID: 35333945
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Impact:
Abstract

Risk-related short-term clinical outcomes after transcatheter aortic valve implantation and their impact on early mortality: an analysis of claims-based data from Germany.

Schofer N, Jeschke E, Kröger J, Baberg H, ... Günster C, Blankenberg S
Objectives
We aimed to define and assess risk-specific adverse outcomes after transcatheter aortic valve implantation (TAVI) in an all-comers patient population based on German administrative claims data.
Methods
Administrative claims data of patients undergoing transvascular TAVI between 2017 and 2019 derived from the largest provider of statutory health-care insurance in Germany were used. Patients\' risk profile was assessed using the established Hospital Frailty Risk (HFR) score and 30-day adverse events were evaluated. Multivariable logistic regression models were applied to investigate the relation of patients\' risk factors to clinical outcomes and, subsequently, of clinical outcomes to mortality.
Results
A total of 21,430 patients were included in the analysis. Of those, 51% were categorized as low-, 37% as intermediate-, and 12% as high-risk TAVI patients according to HFR score. Whereas low-risk TAVI patients showed low rates of periprocedural adverse events, TAVI patients at intermediate or high risk suffered from worse outcomes. An increase in HFR score was associated with an increased risk for all adverse outcome measures. The strongest association of patients\' risk profile and outcome was present for cerebrovascular events and acute renal failure after TAVI. Independent of patients\' risk, the latter showed the strongest relation with early mortality after TAVI.
Conclusions
Differentiated outcomes after TAVI can be assessed using claims-based data and are highly dependent on patients\' risk profile. The present study might be of use to define risk-adjusted outcome margins for TAVI patients in Germany on the basis of health-insurance data.

© 2022. The Author(s).

Clin Res Cardiol: 24 Mar 2022; epub ahead of print
Schofer N, Jeschke E, Kröger J, Baberg H, ... Günster C, Blankenberg S
Clin Res Cardiol: 24 Mar 2022; epub ahead of print | PMID: 35325270
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Impact:
Abstract

Left atrial function index (LAFI) and outcome in patients undergoing transcatheter aortic valve replacement.

Shamekhi J, Nguyen TQA, Sigel H, Maier O, ... Veulemans V, Sedaghat A
Background
Clinical data regarding the association between the left atrial function index (LAFI) and outcome in patients undergoing transcatheter aortic valve replacement (TAVR) are limited.
Objectives
We aimed to investigate the association between the left atrial function index (LAFI) and outcome in patients undergoing TAVR.
Methods
In this retrospective multicenter study, we assessed baseline LAFI in 733 patients undergoing TAVR for severe aortic stenosis in two German high-volume centers between 2008 and 2019. Based on receiver operating characteristic curves, patients were stratified according to their baseline LAFI into two groups (LAFI ≤ 13.5 vs. LAFI > 13.5) and assessed for post-procedural outcome. The primary endpoint of our study was the 1-year all-cause mortality.
Results
Patients with a LAFI ≤ 13.5 had significantly more often atrial fibrillation (p < 0.001), lower LVEF (p < 0.001) and higher levels of NT-proBNP (p < 0.001). After TAVR, a significant improvement in the LAFI as compared to baseline was observed at 12 months after the procedure (28.4 vs. 32.9; p = 0.001). Compared to patients with a LAFI > 13.5, those with a LAFI ≤ 13.5 showed significantly higher rate of 1-year mortality (7.9% vs. 4.0%; p = 0.03). A lower LAFI has been identified as independent predictor of mortality in multivariate analysis (HR (95% CI) 2.0 (1.1-3.9); p = 0.03).
Conclusion
A reduced LAFI is associated with adverse outcome and an independent predictor of mortality in TAVR patients. TAVR improves LAFI within 12 months after the procedure. Left Atrial Function Index (LAFI) in Patients undergoing Transcatheter Aortic Valve Implantation. A Kaplan-Meier survival analysis of 1-year all-cause mortality in patients with LAFI ≤ 13.5 compared with patients with LAFI > 13.5. Comparing rates of 1-year all-cause mortality between the different LAFI groups, we found a significant association between left atrial function and mortality. LAFI Left atrial function index. B Comparison of the mean LAFI before and after TAVR. After long-term follow-up the LAFI improved significantly. LAFI Left atrial function index; FU follow-up. C Assessment of the left atrial function index using the pre-procedural transthoracic echocardiography. A Measurement of the minimal left atrial volume (LAEDV). B Assessment of the maximal left atrial volume (LAESV).

© 2022. The Author(s).

Clin Res Cardiol: 23 Mar 2022; epub ahead of print
Shamekhi J, Nguyen TQA, Sigel H, Maier O, ... Veulemans V, Sedaghat A
Clin Res Cardiol: 23 Mar 2022; epub ahead of print | PMID: 35320406
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Impact:
Abstract

TAVI in patients with low-flow low-gradient aortic stenosis-short-term and long-term outcomes.

Steffen J, Reißig N, Andreae D, Beckmann M, ... Massberg S, Deseive S
Objectives
The study objective was to characterize different groups of low-flow low-gradient (LFLG) aortic stenosis (AS) and determine short-term outcomes and long-term mortality according to Valve Academic Research Consortium-3 (VARC-3) endpoint definitions.
Background
Characteristics and outcomes of patients with LFLG AS undergoing transcatheter aortic valve implantation (TAVI) are poorly understood.
Methods
All patients undergoing TAVI at our center between 2013 and 2019 were screened. Patients were divided into three groups according to mean pressure gradient (dPmean), ejection fraction (LVEF), and stroke volume index (SVi): high gradient (HG) AS (dPmean ≥ 40 mmHg), classical LFLG (cLFLG) AS (dPmean < 40 mmHg, LVEF < 50%), and paradoxical LFLG (pLFLG) AS (dPmean < 40 mmHg, LVEF ≥ 50%, SVi ≤ 35 ml/m2).
Results
We included 1776 patients (956 HG, 447 cLFLG, and 373 pLFLG patients). Most baseline characteristics differed significantly. Median Society of Thoracic Surgeons (STS) score was highest in cLFLG, followed by pLFLG and HG patients (5.0, 3.9 and 3.0, respectively, p < 0.01). Compared to HG patients, odds ratios for the short-term VARC-3 composite endpoints, technical failure (cLFLG, 0.76 [95% confidence interval, 0.40-1.36], pLFLG, 1.37 [0.79-2.31]) and device failure (cLFLG, 1.06 [0.74-1.49], pLFLG, 0.97 [0.66-1.41]) were similar, without relevant differences within LFLG patients. NYHA classes improved equally in all groups. Compared to HG, LFLG patients had a higher 3-year all-cause mortality (STS score-adjusted hazard ratios, cLFLG 2.16 [1.77-2.64], pLFLG 1.53 [1.22-193]), as well as cardiovascular mortality (cLFLG, 2.88 [2.15-3.84], pLFLG, 2.08 [1.50-2.87]).
Conclusions
While 3-year mortality remains high after TAVI in LFLG compared to HG patients, symptoms improve in all subsets after TAVI.

© 2022. The Author(s).

Clin Res Cardiol: 23 Mar 2022; epub ahead of print
Steffen J, Reißig N, Andreae D, Beckmann M, ... Massberg S, Deseive S
Clin Res Cardiol: 23 Mar 2022; epub ahead of print | PMID: 35320407
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Impact:
Abstract

Coronary artery disease, left ventricular function and cardiac biomarkers determine all-cause mortality in cancer patients-a large monocenter cohort study.

Finke D, Heckmann MB, Wilhelm S, Entenmann L, ... Frey N, Lehmann LH
Cancer patients are at risk of suffering from cardiovascular diseases (CVD). Nevertheless, the impact of cardiovascular comorbidity on all-cause mortality (ACM) in large clinical cohorts is not well investigated. In this retrospective cohort study, we collected data from 40,329 patients who were subjected to cardiac catherization from 01/2006 to 12/2017 at University Hospital Heidelberg. The study population included 3666 patients with a diagnosis of cancer prior to catherization and 3666 propensity-score matched non-cancer patients according to age, gender, diabetes and hypertension. 5-year ACM in cancer patients was higher with a reduced left ventricular function (LVEF < 50%; 68.0% vs 50.9%) or cardiac biomarker elevation (high-sensitivity cardiac troponin T (hs-cTnT; 64.6% vs 44.6%) and N-terminal brain natriuretic peptide (NT-proBNP; 62.9% vs 41.4%) compared to cancer patients without cardiac risk. Compared to non-cancer patients, NT-proBNP was found to be significantly higher (median NT-proBNP cancer: 881 ng/L, IQR [254; 3983 ng/L] vs non-cancer: 668 ng/L, IQR [179; 2704 ng/L]; p < 0.001, Wilcoxon-rank sum test) and turned out to predict ACM more accurately than hs-cTnT (NT-proBNP: AUC: 0.74; hs-cTnT: AUC: 0.63; p < 0.001, DeLong\'s test) in cancer patients. Risk factors for atherosclerosis, such as diabetes and age (> 65 years) were significant predictors for increased ACM in cancer patients in a multivariate analysis (OR diabetes: 1.96 (1.39-2.75); p < 0.001; OR age > 65 years: 2.95 (1.68-5.4); p < 0.001, logistic regression). Our data support the notion, that overall outcome in cancer patients who underwent cardiac catherization depends on cardiovascular comorbidities. Therefore, particularly cancer patients may benefit from standardized cardiac care.

© 2022. The Author(s).

Clin Res Cardiol: 21 Mar 2022; epub ahead of print
Finke D, Heckmann MB, Wilhelm S, Entenmann L, ... Frey N, Lehmann LH
Clin Res Cardiol: 21 Mar 2022; epub ahead of print | PMID: 35312818
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Impact:
Abstract

Sudden cardiac death while waiting: do we need the wearable cardioverter-defibrillator?

Israel C, Staudacher I, Leclercq C, Botto GL, ... Katus HA, Thomas D
Sudden cardiac death (SCD) is the most frequent cause of cardiovascular death in industrialized nations. Patients with cardiomyopathy are at increased risk for SCD and may benefit from an implantable cardioverter-defibrillator (ICD). The risk of SCD is highest in the first months after myocardial infarction or first diagnosis of severe non-ischemic cardiomyopathy. On the other hand, left ventricular function may improve in a subset of patients to such an extent that an ICD might no longer be needed. To offer protection from a transient risk of SCD, the wearable cardioverter-defibrillator (WCD) is available. Results of the first randomized clinical trial investigating the role of the WCD after myocardial infarction were recently published. This review is intended to provide insight into data from the VEST trial, and to put these into perspective with studies and clinical experience. As a non-invasive, temporary therapy, the WCD may offer advantages over early ICD implantation. However, recent data demonstrate that patient compliance and education play a crucial role in this new concept of preventing SCD.

© 2022. The Author(s).

Clin Res Cardiol: 19 Mar 2022; epub ahead of print
Israel C, Staudacher I, Leclercq C, Botto GL, ... Katus HA, Thomas D
Clin Res Cardiol: 19 Mar 2022; epub ahead of print | PMID: 35305126
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Impact:
Abstract

Heart failure-related quality-of-life impairment after myocardial infarction.

Wohlfahrt P, Jenča D, Stehlik J, Melenovský V, ... Piťha J, Kautzner J
Aims
Recent advances in therapy led to a significant decrease in mortality and morbidity after myocardial infarction (MI). However, little is known about quality of life (QoL) after MI. We examined heart failure (HF)-related quality-of-life (QoL) impairment, its trajectories, and determinants after MI.
Methods
Data from a single-center prospectively designed registry of consecutive patients hospitalized for MI at a large tertiary cardiology center were utilized. At 1 month and 1 year after hospital discharge, patients completed the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Results
In total, 850 patients (aged 65 ± 12 years, 27% female) hospitalized between June 2017 and October 2020 completed KCCQ at 1 month after discharge. Of these, 38.7% showed HF-related QoL impairment (KCCQ ≤ 75). In addition to characteristics of MI (MI size, diuretics need, heart rate), comorbidities as renal dysfunction and anemia were associated with QoL impairment. Of the 673 eligible, 500 patients (74.3%) completed KCCQ at 1 year after MI. On average, QoL improved by 5.9 ± 16.8 points during the first year after MI (p < 0.001); but, in 18% of patients QoL worsened. Diabetes control and hemoglobin level at the time of hospitalization were associated with QoL worsening.
Conclusion
Two out of 5 patients after MI present with HF-related QoL impairment. In addition to guideline-directed MI management, careful attention to key non-cardiac comorbidities as chronic kidney disease, anemia and diabetes may lead to further augmentation of the benefit of modern therapies in terms of QoL.

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

Clin Res Cardiol: 18 Mar 2022; epub ahead of print
Wohlfahrt P, Jenča D, Stehlik J, Melenovský V, ... Piťha J, Kautzner J
Clin Res Cardiol: 18 Mar 2022; epub ahead of print | PMID: 35304902
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Impact:
Abstract

A systematic review and meta-analysis of the cerebrovascular event incidence after transcatheter aortic valve implantation.

Meertens MM, Macherey S, Asselberghs S, Lee S, ... Frerker C, Schmidt T
Objective
Periinterventional stroke is one of the most feared potential complication, among patients treated with transcatheter aortic valve implantation (TAVI). The purpose of this review was to investigate the incidence of cerebrovascular events and the influence of postinterventional neurologic check-up in patients undergoing TAVI.
Methods
A systematic review and meta-analysis were conducted according to the PRISMA guideline. Three separate electronic searches of the public domains Medline and Clinicaltrials.gov were performed to identify the 30-day incidence of stroke within randomized controlled trials (RCTs) and registries for patients undergoing a TAVI procedure. A meta-analysis was conducted to evaluate the 30-day incidence of stroke within RCTs. Furthermore, we pooled the RCTs in which a scheduled neurological check-up was conducted or not to investigate the effect of this intervention.
Results
Twenty-three studies including 399,532,491 TAVI patients were included, 6370 from RCTs, 857,833 from cerebral-embolic protection device RCTs and 392,288 were adopted from registries. The mean 30-day incidence of stroke among all reviewed studies was 2.33%. In RCTs evaluating TAVI the pooled stroke incidence was 3.86%, among RCTs focused CEP the incidence was 6.4436% and in registries the incidence was 2.29%. Ten RCTs conducted scheduled neurological check-ups, the incidence in these was 4.03% and among the remaining RCTs it was 2.47%. In the meta-analysis, the pooled 30-day stroke incidence was 3.61% (95% CI 2.57-4.79%).
Conclusion
This systematic review demonstrates that the stroke incidences following TAVI differ strongly according to the study design and neurological follow-up. Intense neurological testing increases the incidence of a stroke after TAVI.

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

Clin Res Cardiol: 16 Mar 2022; epub ahead of print
Meertens MM, Macherey S, Asselberghs S, Lee S, ... Frerker C, Schmidt T
Clin Res Cardiol: 16 Mar 2022; epub ahead of print | PMID: 35298700
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Impact:
Abstract

Dabigatran versus vitamin K antagonists for atrial fibrillation in clinical practice: final outcomes from Phase III of the GLORIA-AF registry.

Huisman MV, Teutsch C, Lu S, Diener HC, ... Lip GYH, GLORIA-AF Investigators
Background
Prospectively collected, routine clinical practice-based data on antithrombotic therapy in non-valvular atrial fibrillation (AF) patients are important for assessing real-world comparative outcomes. The objective was to compare the safety and effectiveness of dabigatran versus vitamin K antagonists (VKAs) in patients with newly diagnosed AF.
Methods and results
GLORIA-AF is a large, prospective, global registry program. Consecutive patients with newly diagnosed AF and CHA2DS2-VASc scores ≥ 1 were included and followed for 3 years. To control for differences in patient characteristics, the comparative analysis for dabigatran versus VKA was performed on a propensity score (PS)-matched patient set. Missing data were multiply imputed. Proportional-hazards regression was used to estimate hazard ratios (HRs) for outcomes of interest. Between 2014 and 2016, 21,300 eligible patients were included worldwide: 3839 patients were prescribed dabigatran and 4836 VKA with a median age of 71.0 and 72.0 years, respectively; > 85% in each group had a CHA2DS2-VASc-score ≥ 2. The PS-matched comparative analysis for dabigatran and VKA included on average 3326 pairs of matched initiators. For dabigatran versus VKAs, adjusted HRs (95% confidence intervals) were: stroke 0.89 (0.59-1.34), major bleeding 0.61 (0.42-0.88), all-cause death 0.78 (0.63-0.97), and myocardial infarction 0.89 (0.53-1.48). Further analyses stratified by PS and region provided similar results.
Conclusions
Dabigatran was associated with a 39% reduced risk of major bleeding and 22% reduced risk for all-cause death compared with VKA. Stroke and myocardial infarction risks were similar, confirming a more favorable benefit-risk profile for dabigatran compared with VKA in clinical practice. Clinical trial registration https://www.
Clinicaltrials
gov . NCT01468701, NCT01671007.

© 2022. The Author(s).

Clin Res Cardiol: 15 Mar 2022; epub ahead of print
Huisman MV, Teutsch C, Lu S, Diener HC, ... Lip GYH, GLORIA-AF Investigators
Clin Res Cardiol: 15 Mar 2022; epub ahead of print | PMID: 35294623
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Impact:
Abstract

Clinical impact of changes in mitral regurgitation severity after medical therapy optimization in heart failure.

Pagnesi M, Adamo M, Sama IE, Anker SD, ... Voors AA, Metra M
Background
Few data are available regarding changes in mitral regurgitation (MR) severity with guideline-recommended medical therapy (GRMT) in heart failure (HF). Our aim was to evaluate the evolution and impact of MR after GRMT in the Biology study to Tailored treatment in chronic heart failure (BIOSTAT-CHF).
Methods
A retrospective post-hoc analysis was performed on HF patients from BIOSTAT-CHF with available data on MR status at baseline and at 9-month follow-up after GRMT optimization. The primary endpoint was a composite of all-cause death or HF hospitalization.
Results
Among 1022 patients with data at both time-points, 462 (45.2%) had moderate-severe MR at baseline and 360 (35.2%) had it at 9-month follow-up. Regression of moderate-severe MR from baseline to 9 months occurred in 192/462 patients (41.6%) and worsening from baseline to moderate-severe MR at 9 months occurred in 90/560 patients (16.1%). The presence of moderate-severe MR at 9 months, independent from baseline severity, was associated with an increased risk of the primary endpoint (unadjusted hazard ratio [HR], 2.03; 95% confidence interval [CI], 1.57-2.63; p < 0.001), also after adjusting for the BIOSTAT-CHF risk-prediction model (adjusted HR, 1.85; 95% CI 1.43-2.39; p < 0.001). Younger age, LVEF ≥ 50% and treatment with higher ACEi/ARB doses were associated with a lower likelihood of persistence of moderate-severe MR at 9 months, whereas older age was the only predictor of worsening MR.
Conclusions
Among patients with HF undergoing GRMT optimization, ACEi/ARB up-titration and HFpEF were associated with MR improvement, and the presence of moderate-severe MR after GRMT was associated with worse outcome.

© 2022. The Author(s).

Clin Res Cardiol: 15 Mar 2022; epub ahead of print
Pagnesi M, Adamo M, Sama IE, Anker SD, ... Voors AA, Metra M
Clin Res Cardiol: 15 Mar 2022; epub ahead of print | PMID: 35294624
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Impact:
Abstract

Comparative effectiveness and safety of non-vitamin K antagonists for atrial fibrillation in clinical practice: GLORIA-AF Registry.

Lip GYH, Kotalczyk A, Teutsch C, Diener HC, ... Huisman MV, GLORIA-AF Investigators
Background:
and purpose
Prospectively collected data comparing the safety and effectiveness of individual non-vitamin K antagonists (NOACs) are lacking. Our objective was to directly compare the effectiveness and safety of NOACs in patients with newly diagnosed atrial fibrillation (AF).
Methods
In GLORIA-AF, a large, prospective, global registry program, consecutive patients with newly diagnosed AF were followed for 3 years. The comparative analyses for (1) dabigatran vs rivaroxaban or apixaban and (2) rivaroxaban vs apixaban were performed on propensity score (PS)-matched patient sets. Proportional hazards regression was used to estimate hazard ratios (HRs) for outcomes of interest.
Results
The GLORIA-AF Phase III registry enrolled 21,300 patients between January 2014 and December 2016. Of these, 3839 were prescribed dabigatran, 4015 rivaroxaban and 4505 apixaban, with median ages of 71.0, 71.0, and 73.0 years, respectively. In the PS-matched set, the adjusted HRs and 95% confidence intervals (CIs) for dabigatran vs rivaroxaban were, for stroke: 1.27 (0.79-2.03), major bleeding 0.59 (0.40-0.88), myocardial infarction 0.68 (0.40-1.16), and all-cause death 0.86 (0.67-1.10). For the comparison of dabigatran vs apixaban, in the PS-matched set, the adjusted HRs were, for stroke 1.16 (0.76-1.78), myocardial infarction 0.84 (0.48-1.46), major bleeding 0.98 (0.63-1.52) and all-cause death 1.01 (0.79-1.29). For the comparison of rivaroxaban vs apixaban, in the PS-matched set, the adjusted HRs were, for stroke 0.78 (0.52-1.19), myocardial infarction 0.96 (0.63-1.45), major bleeding 1.54 (1.14-2.08), and all-cause death 0.97 (0.80-1.19).
Conclusions
Patients treated with dabigatran had a 41% lower risk of major bleeding compared with rivaroxaban, but similar risks of stroke, MI, and death. Relative to apixaban, patients treated with dabigatran had similar risks of stroke, major bleeding, MI, and death. Rivaroxaban relative to apixaban had increased risk for major bleeding, but similar risks for stroke, MI, and death.
Registration
URL: https://www.
Clinicaltrials
gov . Unique identifiers: NCT01468701, NCT01671007. Date of registration: September 2013.

© 2022. The Author(s).

Clin Res Cardiol: 15 Mar 2022; epub ahead of print
Lip GYH, Kotalczyk A, Teutsch C, Diener HC, ... Huisman MV, GLORIA-AF Investigators
Clin Res Cardiol: 15 Mar 2022; epub ahead of print | PMID: 35294625
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Impact:
Abstract

Left main coronary artery compression by dilated pulmonary artery in pulmonary arterial hypertension: a systematic review and meta-analysis.

Badea R, Dorobantu DM, Sharabiani MTA, Predescu LM, Coman IM, Ginghina C
Objective
Pulmonary arterial hypertension (PAH) can lead to left main coronary artery compression (LMCo), but data on the impact, screening and treatment are limited. A meta-analysis of LMCo cases could fill the knowledge gaps in this topic.
Methods
Electronic databases were searched for all LMCo/PAH studies, abstracts and case reports including pulmonary artery (PA) size. Restricted maximum likelihood meta-analysis was used to evaluate LMCo-associated factors. Specificity, sensitivity and accuracy of PA size thresholds for diagnosis of LMCo were calculated. Treatment options and outcomes were summarized.
Results
A total of five case-control cohorts and 64 case reports/series (196 LMCo and 438 controls) were included. LMCo cases had higher PA diameter (Hedge\'s g 1.46 [1.09; 1.82]), PA/aorta ratio (Hedge\'s g 1.1 [0.64; 1.55]) and probability of CHD (log odds-ratio 1.22 [0.54; 1.9]) compared to non-LMCo, but not PA pressure or vascular resistance. A 40 mm cut-off for the PA diameter had balanced sensitivity (80.5%), specificity (79%) and accuracy (79.7%) for LMCo diagnosis, while a value of 44 mm had higher accuracy (81.7%), higher specificity (91.5%) but lower sensitivity (71.9%). Pooled mortality after non-conservative treatment (n = 150, predominantly stenting) was 2.7% at up to 22 months of mean follow-up, with 83% survivors having no angina at follow-up.
Conclusion
PA diameter, PA/aorta ratio and CHD are associated with LMCo, while hemodynamic parameters are not. Data from this study support that a PA diameter cut-off between 40 and 44 mm can offer optimal accuracy for LMCo screening. Preferred treatment was coronary stenting, associated with low mid-term mortality and symptom relief. Diagnosis and management of left main coronary artery compression (LMCo) in patients with pulmonary arterial hypertension (PAH).

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

Clin Res Cardiol: 14 Mar 2022; epub ahead of print
Badea R, Dorobantu DM, Sharabiani MTA, Predescu LM, Coman IM, Ginghina C
Clin Res Cardiol: 14 Mar 2022; epub ahead of print | PMID: 35290496
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Impact:
Abstract

How should I treat patients with subclinical atrial fibrillation and atrial high-rate episodes? Current evidence and clinical importance.

Kreimer F, Mügge A, Gotzmann M
Long-term and continuous ECG monitoring using cardiac implantable electronic devices and insertable cardiac monitors has improved the capability of detecting subclinical atrial fibrillation (AF) and atrial high-rate episodes. Previous studies demonstrated a high prevalence (more than 20%) in patients with cardiac implantable electronic devices or insertable cardiac monitors. Subclinical AF and atrial high-rate episodes are often suspected as the cause of prior or potential future ischemic stroke. However, the clinical significance is still uncertain, and the evidence is limited. This review aims to present and discuss the current evidence on the clinical impact of subclinical AF and atrial high-rate episodes. It focuses particularly on the association between the duration of the episodes and major clinical outcomes like thromboembolic events. As subclinical AF and atrial high-rate episodes are presumed to be associated with ischemic strokes, detection will be particularly important in patients with cryptogenic stroke and in high-risk patients for thromboembolism. In this context, it is also interesting whether there is a temporal relationship between the detection of subclinical AF and atrial high-rate episodes and the occurrence of thromboembolic events. In addition, the review will examine the question whether there is a need for a therapy with oral anticoagulation.

© 2022. The Author(s).

Clin Res Cardiol: 14 Mar 2022; epub ahead of print
Kreimer F, Mügge A, Gotzmann M
Clin Res Cardiol: 14 Mar 2022; epub ahead of print | PMID: 35292844
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Impact:
Abstract

Very early infective endocarditis after transcatheter aortic valve replacement.

Panagides V, Abdel-Wahab M, Mangner N, Durand E, ... Holzhey D, Rodés-Cabau J
Background
Scarce data exist about early infective endocarditis (IE) after trans-catheter aortic valve replacement (TAVR).
Objective
The objective was to evaluate the characteristics, management, and outcomes of very early (VE) IE (≤ 30 days) after TAVR.
Methods
This multicenter study included a total of 579 patients from the Infectious Endocarditis after TAVR International Registry who had the diagnosis of definite IE following TAVR.
Results
Ninety-one patients (15.7%) had VE-IE. Factors associated with VE-IE (vs. delayed IE (D-IE)) were female gender (p = 0.047), the use of self-expanding valves (p < 0.001), stroke (p = 0.019), and sepsis (p < 0.001) after TAVR. Staphylococcus aureus was the main pathogen among VE-IE patients (35.2% vs. 22.7% in the D-IE group, p = 0.012), and 31.2% of Staphylococcus aureus infections in the VE-IE group were methicillin-resistant (vs. 14.3% in the D-IE group, p = 0.001). The second-most common germ was enterococci (34.1% vs. 24.4% in D-IE cases, p = 0.05). VE-IE was associated with very high in-hospital (44%) and 1-year (54%) mortality rates. Acute renal failure following TAVR (p = 0.001) and the presence of a non-enterococci pathogen (p < 0.001) were associated with an increased risk of death.
Conclusion
A significant proportion of IE episodes following TAVR occurs within a few weeks following the procedure and are associated with dismal outcomes. Some baseline and TAVR procedural factors were associated with VE-IE, and Staphylococcus aureus and enterococci were the main causative pathogens. These results may help to select the more appropriate antibiotic prophylaxis in TAVR procedures and guide the initial antibiotic therapy in those cases with a clinical suspicion of IE. Very early infective endocarditis after trans-catheter aortic valve replacement. VE-IE indicates very early infective endocarditis (≤30 days post TAVR). D-IE indicates delayed infective endocarditis.

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

Clin Res Cardiol: 08 Mar 2022; epub ahead of print
Panagides V, Abdel-Wahab M, Mangner N, Durand E, ... Holzhey D, Rodés-Cabau J
Clin Res Cardiol: 08 Mar 2022; epub ahead of print | PMID: 35262756
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Impact:
Abstract

Pulmonary artery sensor system pressure monitoring to improve heart failure outcomes (PASSPORT-HF): rationale and design of the PASSPORT-HF multicenter randomized clinical trial.

Störk S, Bernhardt A, Böhm M, Brachmann J, ... Angermann C, Aßmus B
Background
Remote monitoring of patients with New York Heart Association (NYHA) functional class III heart failure (HF) using daily transmission of pulmonary artery (PA) pressure values has shown a reduction in HF-related hospitalizations and improved quality of life in patients.
Objectives
PASSPORT-HF is a prospective, randomized, open, multicenter trial evaluating the effects of a hemodynamic-guided, HF nurse-led care approach using the CardioMEMS™ HF-System on clinical end points.
Methods and results
The PASSPORT-HF trial has been commissioned by the German Federal Joint Committee (G-BA) to ascertain the efficacy of PA pressure-guided remote care in the German health-care system. PASSPORT-HF includes adult HF patients in NYHA functional class III, who experienced an HF-related hospitalization within the last 12 months. Patients with reduced ejection fraction must be on stable guideline-directed pharmacotherapy. Patients will be randomized centrally 1:1 to implantation of a CardioMEMS™ sensor or control. All patients will receive post-discharge support facilitated by trained HF nurses providing structured telephone-based care. The trial will enroll 554 patients at about 50 study sites. The primary end point is a composite of the number of unplanned HF-related rehospitalizations or all-cause death after 12 months of follow-up, and all events will be adjudicated centrally. Secondary end points include device/system-related complications, components of the primary end point, days alive and out of hospital, disease-specific and generic health-related quality of life including their sub-scales, and laboratory parameters of organ damage and disease progression.
Conclusions
PASSPORT-HF will define the efficacy of implementing hemodynamic monitoring as a novel disease management tool in routine outpatient care.
Trial registration
ClinicalTrials.gov; NCT04398654, 13-MAY-2020.

© 2022. The Author(s).

Clin Res Cardiol: 03 Mar 2022; epub ahead of print
Störk S, Bernhardt A, Böhm M, Brachmann J, ... Angermann C, Aßmus B
Clin Res Cardiol: 03 Mar 2022; epub ahead of print | PMID: 35246723
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Impact:
Abstract

Morbidity and mortality in adults with congenital heart defects in the third and fourth life decade.

Müller MJ, Norozi K, Caroline J, Sedlak N, ... Geyer S, Dellas C
Objectives
The population of adults with congenital heart defects (ACHD) is continuously growing. Data on morbidity and mortality of ACHD are limited. This longitudinal observational study examined a group of ACHD with surgically corrected or palliated congenital heart defects (CHD) during a 15-year period.
Methods
ACHD that had participated in the initial study were invited for a follow-up examination. Mortality and hospitalization data were compared with a healthy control group.
Results
From 05/2017 to 04/2019 a total of 249/364 (68%) ACHD participated in the follow-up study: 21% had mild, 60% moderate and 19% severe CHD. During the observational period, 290 health incidents occurred (cardiac catheterization 37%, cardiovascular surgery 27%, electrophysiological study/ablation 20%, catheter interventional treatment 14%, non-cardiac surgery 3%). Events were more frequent in ACHD with moderate (53%) and severe (87%) compared to those with mild CHD (p < 0.001). 24 individuals died at a median age of 43 years during the observation period. 29% of them had moderate and 71% severe CHD corresponding to a mortality rate of 0%, 0.29% and 1.68% per patient-year in ACHD with mild, moderate and severe CHD. Long-term survival was significantly reduced in patients with severe CHD in comparison to individuals with mild and moderate CHD (p < 0.001).
Conclusion
After correction or palliation of CHD, there was remarkable ongoing morbidity and mortality in ACHD patients over the 15-year observation period, particularly in individuals with moderate and severe CHD when compared with the general population. Thus, life-long special care is required for all surgically corrected or palliated ACHD patients.

© 2022. The Author(s).

Clin Res Cardiol: 28 Feb 2022; epub ahead of print
Müller MJ, Norozi K, Caroline J, Sedlak N, ... Geyer S, Dellas C
Clin Res Cardiol: 28 Feb 2022; epub ahead of print | PMID: 35229166
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Impact:
Abstract

Prognostic value of changes in high-sensitivity cardiac troponin T beyond biological variation in stable outpatients with cardiovascular disease: a validation study.

Biener M, Giannitsis E, Hogrefe K, Mueller-Hennessen M, ... Frankenstein L, Täger T
Objective
To evaluate the prognostic implications of longitudinal long-term changes beyond the biological variation of high-sensitivity cardiac troponin T (hs-cTnT) in outpatients with stable or asymptomatic cardiovascular disease (CV) and to assess possible differences in the prognostic value while using reference change value (RCV) and minimal important differences (MID) as metric for biological variation.
Methods
Hs-cTnT was measured at index visit and after 12 months in outpatients presenting for routine follow-up. The prognostic relevance of a concentration change of hs-cTnT values exceeding the biological variation defined by RCV and MID of a healthy population within the next 12 months following the stable initial period was determined regarding three endpoints: all-cause mortality (EP1), a composite of all-cause mortality, non-fatal myocardial infarction and stroke (EP2), and a composite of all-cause mortality, non-fatal myocardial infarction, stroke, hospitalization for acute coronary syndrome (ACS) or decompensated heart failure, and planned and unplanned percutaneous coronary interventions (PCI, EP3).
Results
Change in hs-cTnT values exceeding the biovariability defined by MID but not by RCV discriminated a group with a higher cardiovascular risk profile. Changes within MID were associated with uneventful course (NPV 91.6-99.7%) while changes exceeding MID were associated with a higher occurrence of all endpoints within the next 365 days indicating a 5.5-fold increased risk for EP 1 (p = 0.041) a 2.4-fold increased risk for EP 2 (p = 0.049) and a 1.9-fold increased risk for EP 3 (p < 0.0001).
Conclusions
In stable outpatients MID calculated from hs-cTnT changes measured 365 ± 120 days apart are helpful to predict an uneventful clinical course.
Clinical trials identifier
NCT01954303.

© 2021. The Author(s).

Clin Res Cardiol: 27 Feb 2022; 111:333-342
Biener M, Giannitsis E, Hogrefe K, Mueller-Hennessen M, ... Frankenstein L, Täger T
Clin Res Cardiol: 27 Feb 2022; 111:333-342 | PMID: 34694435
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Impact:
Abstract

Hypertension control and end-stage renal disease in atrial fibrillation: a nationwide population-based cohort study.

Kwon S, Lee SR, Choi EK, Jung JH, ... Oh S, Lip GYH
Background
The impact of hypertension control on the risk of end-stage renal disease (ESRD) in patients newly diagnosed with atrial fibrillation (AF) is unknown. This study aimed to investigate the impact of hypertension control on incident ESRD among AF patients.
Methods
From the National Health Information database of Korea, we identified ESRD-free patients who were newly diagnosed with AF during 2010 and 2016. The patients were divided into four groups (NN, NH, HN, and HH) according to combinations of dichotomous blood pressure status [normotensive (N) or hypertensive (H)] of two consecutive check-ups. The primary outcome was incident ESRD. Cox proportional hazard regression analysis evaluated ESRD risks across the groups. The association between ESRD risks and changes in blood pressures was also evaluated.
Results
During the mean follow-up duration of 3.2 ± 1.9 years, 130,259 ESRD-free patients with AF (mean age 63.1 ± 12.1 years, male 61.2%) were evaluated. Compared to NN, other patient groups showed higher ESRD risks [hazard ratio (95% confidence interval) = 1.43 (1.08-1.89), 1.39 (1.08-1.79), and 2.03 (1.55-2.65) for NH, HN, and HH, respectively]. There was a significant trend of decreasing risks of ESRD in patients with greater reductions in systolic blood pressure after AF diagnosis (p for-trend < 0.001). The association between hypertension control and the ESRD risk was more accentuated in patients with chronic kidney disease.
Conclusion
Uncontrolled hypertension was associated with an increased risk of incident ESRD in patients with newly diagnosed AF. This study emphasizes the importance of blood pressure control once patients are diagnosed with AF to prevent ESRD.

© 2021. Springer-Verlag GmbH Germany, part of Springer Nature.

Clin Res Cardiol: 27 Feb 2022; 111:284-293
Kwon S, Lee SR, Choi EK, Jung JH, ... Oh S, Lip GYH
Clin Res Cardiol: 27 Feb 2022; 111:284-293 | PMID: 34216251
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Impact:
Abstract

Associations between kidney function and outcomes of comprehensive cardiac rehabilitation in patients with heart failure.

Hamazaki N, Kamiya K, Yamamoto S, Nozaki K, ... Matsunaga A, Ako J
Aims
To investigate the impact of baseline kidney function on outcomes following comprehensive cardiac rehabilitation (CR) in patients with heart failure (HF).
Methods
We reviewed a total of 3,727 patients who were admitted for HF treatment. Estimated glomerular filtration rate (eGFR), quadriceps strength (QS), and 6-min walk distance (6MWD) were measured at hospital discharge as a baseline and 5 months thereafter in participants of outpatient comprehensive CR. The association between outpatient CR participation and all-cause events was evaluated using propensity score-matched analysis in subgroups across eGFR stages. The changes in QS and 6MWD following 5-month CR were compared between eGFR stages.
Results
Out of the studied patients, 1585 (42.5%) participated in outpatient CR. After propensity matching for clinical confounders, 2680 patients were included for analysis (pairs of n = 1340 outpatient CR participants and nonparticipants). The participation in outpatient CR was significantly associated with low clinical events in subgroups of eGFR ≥ 60 [hazard ratio (HR): 0.65, 95% confidence interval (CI): 0.51-0.84] and eGFR 45-60 (HR: 0.71, 95% CI: 0.55-0.92), but not in eGFR 30-45 (HR: 0.83, 95% CI: 0.64-1.08) and eGFR < 30 (HR: 0.88, 95% CI: 0.69-1.12). QS and 6MWD were significantly higher after 5-month CR than those at baseline (P < 0.001, respectively), but lower baseline eGFR correlated with lower changes in QS and 6MWD (trend P < 0.001, respectively).
Conclusions
Although low baseline kidney function attenuates the outcomes of CR, outpatient CR seems to be associated with a better prognosis and positive change in physical function in HF patients with low kidney function.

© 2021. Springer-Verlag GmbH Germany, part of Springer Nature.

Clin Res Cardiol: 27 Feb 2022; 111:253-263
Hamazaki N, Kamiya K, Yamamoto S, Nozaki K, ... Matsunaga A, Ako J
Clin Res Cardiol: 27 Feb 2022; 111:253-263 | PMID: 34057614
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Impact:
Abstract

Feasibility and effectiveness of a multidimensional post-discharge disease management programme for heart failure patients in clinical practice: the HerzMobil Tirol programme.

Poelzl G, Egelseer-Bruendl T, Pfeifer B, Modre-Osprian R, ... Ammenwerth E, Bauer A
Aims
It remains unclear whether transitional care management outside of a clinical trial setting provides benefits for patients with acute heart failure (AHF) after hospitalization. We evaluated the feasibility and effectiveness of a multidimensional post-discharge disease management programme using a telemedical monitoring system incorporated in a comprehensive network of heart failure nurses, resident physicians, and secondary and tertiary referral centres (HerzMobil Tirol, HMT), METHODS AND
Results:
The non-randomized study included 508 AHF patients that were managed in HMT (n = 251) or contemporaneously in usual care (UC, n = 257) after discharge from hospital from 2016 to 2019. Groups were retrospectively matched for age and sex. The primary endpoint was time to HF readmission and all-cause mortality within 6 months. Multivariable Cox proportional hazard models were used to assess the effectiveness. The primary endpoint occurred in 48 patients (19.1%) in HMT and 89 (34.6%) in UC. Compared with UC, management by HMT was associated with a 46%-reduction in the primary endpoint (adjusted HR 0.54; 95% CI 0.37-0.77; P < 0.001). Subgroup analyses revealed consistent effectiveness. The composite of recurrent HF hospitalization and death within 6 months per 100 patient-years was 64.2 in HMT and 108.2 in UC (adjusted HR 0.41; 95% CI 0.29-0.55; P < 0.001 with death considered as a competing risk). After 1 year, 25 (10%) patients died in HMT compared with 66 (25.7%) in UC (HR 0.38; 95% CI 0.23-0.61, P < 0.001).
Conclusions
A multidimensional post-discharge disease management programme, comprising a telemedical monitoring system incorporated in a comprehensive network of specialized heart failure nurses and resident physicians, is feasible and effective in clinical practice.

© 2021. Springer-Verlag GmbH Germany, part of Springer Nature.

Clin Res Cardiol: 27 Feb 2022; 111:294-307
Poelzl G, Egelseer-Bruendl T, Pfeifer B, Modre-Osprian R, ... Ammenwerth E, Bauer A
Clin Res Cardiol: 27 Feb 2022; 111:294-307 | PMID: 34269863
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Impact:
Abstract

Improvement of outcome prediction of hospitalized patients with COVID-19 by a dual marker strategy using high-sensitive cardiac troponin I and copeptin.

Kaufmann CC, Ahmed A, Kassem M, Freynhofer MK, ... Giannitsis E, Huber K
Background
COVID-19 has been associated with a high prevalence of myocardial injury and increased cardiovascular morbidity. Copeptin, a marker of vasopressin release, has been previously established as a risk marker in both infectious and cardiovascular disease.
Methods
This prospective, observational study of patients with laboratory-confirmed COVID-19 infection was conducted from June 6th to November 26th, 2020 in a tertiary care hospital. Copeptin and high-sensitive cardiac troponin I (hs-cTnI) levels on admission were collected and tested for their association with the primary composite endpoint of ICU admission or 28-day mortality.
Results
A total of 213 eligible patients with COVID-19 were included of whom 55 (25.8%) reached the primary endpoint. Median levels of copeptin and hs-cTnI at admission were significantly higher in patients with an adverse outcome (Copeptin 29.6 pmol/L, [IQR, 16.2-77.8] vs 17.2 pmol/L [IQR, 7.4-41.0] and hs-cTnI 22.8 ng/L [IQR, 11.5-97.5] vs 10.2 ng/L [5.5-23.1], P < 0.001 respectively). ROC analysis demonstrated an optimal cut-off of 19.3 pmol/L for copeptin and 16.8 ng/L for hs-cTnI and an increase of either biomarker was significantly associated with the primary endpoint. The combination of raised hs-cTnI and copeptin yielded a superior prognostic value to individual measurement of biomarkers and was a strong prognostic marker upon multivariable logistic regression analysis (OR 4.274 [95% CI, 1.995-9.154], P < 0.001). Addition of copeptin and hs-cTnI to established risk models improved C-statistics and net reclassification indices.
Conclusion
The combination of raised copeptin and hs-cTnI upon admission is an independent predictor of ICU admission or 28-day mortality in hospitalized patients with COVID-19.

© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.

Clin Res Cardiol: 27 Feb 2022; 111:343-354
Kaufmann CC, Ahmed A, Kassem M, Freynhofer MK, ... Giannitsis E, Huber K
Clin Res Cardiol: 27 Feb 2022; 111:343-354 | PMID: 34782921
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Impact:
Abstract

Effects of face masks on performance and cardiorespiratory response in well-trained athletes.

Egger F, Blumenauer D, Fischer P, Venhorst A, ... Meyer T, Mahfoud F
Background
During the COVID-19 pandemic, compulsory masks became an integral part of outdoor sports such as jogging in crowded areas (e.g. city parks) as well as indoor sports in gyms and sports centers. This study, therefore, aimed to investigate the effects of medical face masks on performance and cardiorespiratory parameters in athletes.
Methods
In a randomized, cross-over design, 16 well-trained athletes (age 27 ± 7 years, peak oxygen consumption 56.2 ± 5.6 ml kg-1 min-1, maximum performance 5.1 ± 0.5 Watt kg-1) underwent three stepwise incremental exercise tests to exhaustion without mask (NM), with surgical mask (SM) and FFP2 mask (FFP2). Cardiorespiratory and metabolic responses were monitored by spiroergometry and blood lactate (BLa) testing throughout the tests.
Results
There was a large effect of masks on performance with a significant reduction of maximum performance with SM (355 ± 41 Watt) and FFP2 (364 ± 43 Watt) compared to NM (377 ± 40 Watt), respectively (p < 0.001; ηp2 = 0.50). A large interaction effect with a reduction of both oxygen consumption (p < 0.001; ηp2 = 0.34) and minute ventilation (p < 0.001; ηp2 = 0.39) was observed. At the termination of the test with SM 11 of 16 subjects reported acute dyspnea from the suction of the wet and deformed mask. No difference in performance was observed at the individual anaerobic threshold (p = 0.90).
Conclusion
Both SM and to a lesser extent FFP2 were associated with reduced maximum performance, minute ventilation, and oxygen consumption. For strenuous anaerobic exercise, an FFP2 mask may be preferred over an SM.

© 2021. The Author(s).

Clin Res Cardiol: 27 Feb 2022; 111:264-271
Egger F, Blumenauer D, Fischer P, Venhorst A, ... Meyer T, Mahfoud F
Clin Res Cardiol: 27 Feb 2022; 111:264-271 | PMID: 34091726
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Impact:
Abstract

Omega-3 fatty acid blood levels are inversely associated with cardiometabolic risk factors in HFpEF patients: the Aldo-DHF randomized controlled trial.

Lechner K, Scherr J, Lorenz E, Lechner B, ... Duvinage A, Edelmann F
Objectives
To evaluate associations of omega-3 fatty acid (O3-FA) blood levels with cardiometabolic risk markers, functional capacity and cardiac function/morphology in patients with heart failure with preserved ejection fraction (HFpEF).
Background
O3-FA have been linked to reduced risk for HF and associated phenotypic traits in experimental/clinical studies.
Methods
This is a cross-sectional analysis of data from the Aldo-DHF-RCT. From 422 patients, the omega-3-index (O3I = EPA + DHA) was analyzed at baseline in n = 404 using the HS-Omega-3-Index® methodology. Patient characteristics were; 67 ± 8 years, 53% female, NYHA II/III (87/13%), ejection fraction ≥ 50%, E/e\' 7.1 ± 1.5; median NT-proBNP 158 ng/L (IQR 82-298). Pearson\'s correlation coefficient and multiple linear regression analyses, using sex and age as covariates, were used to describe associations of the O3I with metabolic phenotype, functional capacity, echocardiographic markers for LVDF, and neurohumoral activation at baseline/12 months.
Results
The O3I was below (< 8%), within (8-11%), and higher (> 11%) than the target range in 374 (93%), 29 (7%), and 1 (0.2%) patients, respectively. Mean O3I was 5.7 ± 1.7%. The O3I was inversely associated with HbA1c (r = - 0.139, p = 0.006), triglycerides-to-HDL-C ratio (r = - 0.12, p = 0.017), triglycerides (r = - 0.117, p = 0.02), non-HDL-C (r = - 0.101, p = 0.044), body-mass-index (r = - 0.149, p = 0.003), waist circumference (r = - 0.121, p = 0.015), waist-to-height ratio (r = - 0.141, p = 0.005), and positively associated with submaximal aerobic capacity (r = 0.113, p = 0.023) and LVEF (r = 0.211, p < 0.001) at baseline. Higher O3I at baseline was predictive of submaximal aerobic capacity (β = 15.614, p < 0,001), maximal aerobic capacity (β = 0.399, p = 0.005) and LVEF (β = 0.698, p = 0.007) at 12 months.
Conclusions
Higher O3I was associated with a more favorable cardiometabolic risk profile and predictive of higher submaximal/maximal aerobic capacity and lower BMI/truncal adiposity in HFpEF patients. Omega-3 fatty acid blood levels are inversely associated with cardiometabolic risk factors in HFpEF patients. Higher O3I was associated with a more favorable cardiometabolic risk profile and aerobic capacity (left) but did not correlate with echocardiographic markers for left ventricular diastolic function or neurohumoral activation (right). An O3I-driven intervention trial might be warranted to answer the question whether O3-FA in therapeutic doses (with the target O3I 8-11%) impact on echocardiographic markers for left ventricular diastolic function and neurohumoral activation in patients with HFpEF. This figure contains modified images from Servier Medical Art ( https://smart.servier.com ) licensed by a Creative Commons Attribution 3.0 Unported License.

© 2021. The Author(s).

Clin Res Cardiol: 27 Feb 2022; 111:308-321
Lechner K, Scherr J, Lorenz E, Lechner B, ... Duvinage A, Edelmann F
Clin Res Cardiol: 27 Feb 2022; 111:308-321 | PMID: 34453204
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Impact:
Abstract

Pre-medication with oral anticoagulants is associated with better outcomes in a large multinational COVID-19 cohort with cardiovascular comorbidities.

Rieder M, Gauchel N, Kaier K, Jakob C, ... Rieg S, Duerschmied D
Aims
Coagulopathy and venous thromboembolism are common findings in coronavirus disease 2019 (COVID-19) and are associated with poor outcome. Timely initiation of anticoagulation after hospital admission was shown to be beneficial. In this study we aim to examine the association of pre-existing oral anticoagulation (OAC) with outcome among a cohort of SARS-CoV-2 infected patients.
Methods and results
We analysed the data from the large multi-national Lean European Open Survey on SARS-CoV-2 infected patients (LEOSS) from March to August 2020. Patients with SARS-CoV-2 infection were eligible for inclusion. We retrospectively analysed the association of pre-existing OAC with all-cause mortality. Secondary outcome measures included COVID-19-related mortality, recovery and composite endpoints combining death and/or thrombotic event and death and/or bleeding event. We restricted bleeding events to intracerebral bleeding in this analysis to ensure clinical relevance and to limit reporting errors. A total of 1 433 SARS-CoV-2 infected patients were analysed, while 334 patients (23.3%) had an existing premedication with OAC and 1 099 patients (79.7%) had no OAC. After risk adjustment for comorbidities, pre-existing OAC showed a protective influence on the endpoint death (OR 0.62, P = 0.013) as well as the secondary endpoints COVID-19-related death (OR 0.64, P = 0.023) and non-recovery (OR 0.66, P = 0.014). The combined endpoint death or thrombotic event tended to be less frequent in patients on OAC (OR 0.71, P = 0.056).
Conclusions
Pre-existing OAC is protective in COVID-19, irrespective of anticoagulation regime during hospital stay and independent of the stage and course of disease.

© 2021. The Author(s).

Clin Res Cardiol: 27 Feb 2022; 111:322-332
Rieder M, Gauchel N, Kaier K, Jakob C, ... Rieg S, Duerschmied D
Clin Res Cardiol: 27 Feb 2022; 111:322-332 | PMID: 34546427
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Impact:
Abstract

Cardiovascular profiling in the diabetic continuum: results from the population-based Gutenberg Health Study.

Schmitt VH, Leuschner A, Jünger C, Pinto A, ... Wild PS, Münzel T
Aims
To assess the prevalence of type 2 diabetes mellitus (T2DM) and prediabetes in the general population and to investigate the associated cardiovascular burden and clinical outcome.
Methods and results
The study sample comprised 15,010 individuals aged 35-74 years of the population-based Gutenberg Health Study. Subjects were classified into euglycaemia, prediabetes and T2DM according to clinical and metabolic (HbA1c) information. The prevalence of prediabetes was 9.5% (n = 1415) and of T2DM 8.9% (n = 1316). Prediabetes and T2DM showed a significantly increased prevalence ratio (PR) for age, obesity, active smoking, dyslipidemia, and arterial hypertension compared to euglycaemia (for all, P < 0.0001). In a robust Poisson regression analysis, prediabetes was established as an independent predictor of clinically-prevalent cardiovascular disease (PRprediabetes 1.20, 95% CI 1.07-1.35, P = 0.002) and represented as a risk factor for asymptomatic cardiovascular organ damage independent of traditional risk factors (PR 1.04, 95% CI 1.01-1.08, P = 0.025). Prediabetes was associated with a 1.5-fold increased 10-year risk for cardiovascular disease compared to euglycaemia. In Cox regression analysis, prediabetes (HR 2.10, 95% CI 1.76-2.51, P < 0.0001) and T2DM (HR 4.28, 95% CI 3.73-4.92, P < 0.0001) indicated for an increased risk of death. After adjustment for age, sex and traditional cardiovascular risk factors, only T2DM (HR 1.89, 95% CI 1.63-2.20, P < 0.0001) remained independently associated with increased all-cause mortality.
Conclusion
Besides T2DM, also prediabetes inherits a significant cardiovascular burden, which translates into poor clinical outcome and indicates the need for new concepts regarding the prevention of cardiometabolic disorders.

© 2021. The Author(s).

Clin Res Cardiol: 27 Feb 2022; 111:272-283
Schmitt VH, Leuschner A, Jünger C, Pinto A, ... Wild PS, Münzel T
Clin Res Cardiol: 27 Feb 2022; 111:272-283 | PMID: 34169342
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Impact:
Abstract

Use of fixed-dose combination antihypertensives in Germany between 2016 and 2020: an example of guideline inertia.

Mahfoud F, Kieble M, Enners S, Kintscher U, ... Böhm M, Schulz M
Background
The 2018 European Society of Cardiology (ESC)/European Society of Hypertension (ESH) guidelines for the management of hypertension highlight the importance of fixed-dose combinations (FDC) for the treatment of hypertension and recommend initial single-pill combination therapy in almost all patients. However, data on the implementation of these recommendations in clinical practice are scarce.
Methods
Data from the German Institute for Drug Use Evaluation (DAPI) were analyzed and extrapolated accounting for approximately 88% of Germany\'s population (approximately 73.3 million subjects). All antihypertensive (AHT) FDC products available on the German market were included in the analyses. We examined the time course of dispensed packages between January 2016 and December 2020.
Results
FDCs accounted for 15.4% of all AHT in 2016 and for 10.9% in 2020. While dispensing of all AHT increased slightly from year to year (2016: 143.8 million, 2020: 153.2 million packs), dispensing of FDCs decreased from 22.2 million (2016) to 16.6 million (2020) packs. Dispensing of FDCs containing hydrochlorothiazide (HCT) declined considerably from 2016 to 2020 (Q1 2016: 4.65 million, Q4 2020: 3.13 million packs). Accordingly, the proportion of HCT-containing combinations in all FDCs decreased from 85.3 to 74.2% from Q1 2016 to Q4 2020. Patients younger than 80 years were prescribed FDCs more frequently (14.6% of all AHT, based on the entire evaluation period) than patients 80 years and older (10.0%). In both age groups, this proportion decreased continuously over time.
Conclusions
Almost 2 years following the release of the 2018 ESC/ESH guidelines, only 10.9% of the prescribed packs of antihypertensive drugs in 2020 were FDC products, documenting underutilization of current guideline recommendations on pharmacotherapy in hypertension. Structured programs to evidence-based decision support are required to improve guideline inertia and patient outcomes, eventually.

© 2022. The Author(s).

Clin Res Cardiol: 26 Feb 2022; epub ahead of print
Mahfoud F, Kieble M, Enners S, Kintscher U, ... Böhm M, Schulz M
Clin Res Cardiol: 26 Feb 2022; epub ahead of print | PMID: 35220445
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Impact:
Abstract

Drug-coated balloons for small coronary artery disease in patients with chronic kidney disease: a pre-specified analysis of the BASKET-SMALL 2 trial.

Mahfoud F, Farah A, Ohlow MA, Mangner N, ... Scheller B, Jeger RV
Background
Data on the safety and efficacy of drug-coated balloon (DCB) compared to drug-eluting stent (DES) in patients with chronic kidney disease (CKD) are scarce, particularly at long term. This pre-specified analysis aimed to investigate the 3-year efficacy and safety of DCB versus DES for small coronary artery disease (< 3 mm) according to renal function at baseline.
Methods
BASKET-SMALL-2 was a large multi-center, randomized, controlled trial that tested the efficacy and safety of DCBs (n = 382) against DESs (n = 376) in small vessel disease. CKD was defined as eGFR < 60 ml/min/1.73m2. The primary endpoint was the composite of cardiac death, non-fatal myocardial infarction, and target vessel revascularization (MACE) during 3 years.
Results
A total of 174/758 (23%) patients had CKD, out of which 91 were randomized to DCB and 83 to DES implantation. The primary efficacy outcome during 3 years was similar in both, DCB and DES patients (HR 0.98; 95%-CI 0.67-1.44; p = 0.937) and patients with and without CKD (HR 1.18; 95%-CI 0.76-1.83; p = 0.462), respectively. Rates of cardiac death and all-cause death were significantly higher among patients with CKD but not affected by treatment with DCB or DES. Major bleeding events were lower in the DCB when compared to the DES group (12 vs. 3, HR 0.26; 95%-CI 0.07-0.92; p = 0.037) and not influenced by presence of CKD.
Conclusions
The long-term efficacy and safety of DCB was similar in patients with and without CKD. The use of DCB was associated with significantly fewer major bleeding events (NCT01574534). Central Illustration. Drug-coated balloon versus drug-eluting stents in small coronary artery disease with and without chronic kidney disease, a prespecified subgroup analysis of the BASKET-SMALL 2 trial.

© 2022. The Author(s).

Clin Res Cardiol: 26 Feb 2022; epub ahead of print
Mahfoud F, Farah A, Ohlow MA, Mangner N, ... Scheller B, Jeger RV
Clin Res Cardiol: 26 Feb 2022; epub ahead of print | PMID: 35220449
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Impact:
Abstract

Real-world anticoagulatory treatment after percutaneous mitral valve repair using MitraClip: a retrospective, observational study on 1300 patients.

Hohmann C, Ludwig M, Walker J, Iliadis C, ... Baldus S, Pfister R
Aims
This study sought to investigate current anticoagulatory treatment patterns and clinical outcome in patients undergoing transcatheter mitral valve repair (MitraClip).
Methods and results
In a retrospective study of a German claims database (InGef research database), anticoagulatory treatment regimens were assessed using any drug prescription post discharge within the first 90 days after MitraClip procedure. Clinical events between 30 days and 6 months were examined by treatment regime. The study population comprised 1342 patients undergoing MitraClip procedure between 2014 and 2018. 22.4% received antiplatelet monotherapy, 20.8% oral anticoagulation (OAC) plus antiplatelet therapy, 19.4% OAC monotherapy, 11.7% dual antiplatelet therapy, 2.8% triple therapy and 21.0% did not receive any anticoagulatory drugs. 63% of patients with OAC received non-vitamin-K antagonist oral anticoagulants (NOAC). A total of 168 patients were newly prescribed OAC after MitraClip, of whom 12 patients (7.1%) had no diagnosis of atrial fibrillation or venous thromboembolism. 40% of patients with OAC prior to MitraClip did not have any OAC after MitraClip. The adjusted risk of all-cause mortality was significantly increased in patients with no anticoagulatory treatment (HR 3.84, 95% CI 2.33-6.33, p < 0.0001) when compared to antiplatelet monotherapy whereas the other regimes were not significantly different.
Conclusions
This large real-world data analysis demonstrates a heterogeneous spectrum of prescriptions for anticoagulant therapies after MitraClip. Considering relevant differences in clinical outcome across treatment groups, major effort is warranted for controlled trials in order to establish evidence-based recommendations on anticoagulatory treatment after percutaneous mitral valve repair.

© 2022. The Author(s).

Clin Res Cardiol: 25 Feb 2022; epub ahead of print
Hohmann C, Ludwig M, Walker J, Iliadis C, ... Baldus S, Pfister R
Clin Res Cardiol: 25 Feb 2022; epub ahead of print | PMID: 35220447
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Impact:
Abstract

Gut microbiota-dependent metabolite trimethylamine N-oxide (TMAO) and cardiovascular risk in patients with suspected functionally relevant coronary artery disease (fCAD).

Amrein M, Li XS, Walter J, Wang Z, ... Hazen SL, Mueller C
Background
Trimethylamine N-oxide (TMAO) has been associated with cardiovascular outcomes. However, the diagnostic value of TMAO and its precursors have not been assessed for functionally relevant coronary artery disease (fCAD) and its prognostic potential in this setting needs to be evaluated.
Methods
Among 1726 patients with suspected fCAD serum TMAO, and its precursors betaine, choline and carnitine, were quantified using liquid chromatography tandem mass spectrometry. Diagnosis of fCAD was performed by myocardial perfusion single photon emission tomography (MPI-SPECT) and coronary angiography blinded to marker concentrations. Incident all-cause death, cardiovascular death (CVD) and myocardial infarction (MI) were assessed during 5-years follow-up.
Results
Concentrations of TMAO, betaine, choline and carnitine were significantly higher in patients with fCAD versus those without (TMAO 5.33 μM vs 4.66 μM, p < 0.001); however, diagnostic accuracy was low (TMAO area under the receiver operating curve [AUC]: 0.56, 95% CI [0.53-0.59], p < 0.001). In prognostic analyses, TMAO, choline and carnitine above the median were associated with significantly (p < 0.001 for all) higher cumulative events for death and CVD during 5-years follow-up. TMAO remained a significant predictor for death and CVD even in full models adjusted for renal function (HR = 1.58 (1.16, 2.14), p = 0.003; HR = 1.66 [1.07, 2.59], p = 0.025). Prognostic discriminative accuracy for TMAO was good and robust for death and CVD (2-years AUC for CVD 0.73, 95% CI [0.65-0.80]).
Conclusion
TMAO and its precursors, betaine, choline and carnitine were significantly associated with fCAD, but with limited diagnostic value. TMAO was a strong predictor for incident death and CVD in patients with suspected fCAD.
Clinical trial registration
NCT01838148.

© 2022. The Author(s).

Clin Res Cardiol: 25 Feb 2022; epub ahead of print
Amrein M, Li XS, Walter J, Wang Z, ... Hazen SL, Mueller C
Clin Res Cardiol: 25 Feb 2022; epub ahead of print | PMID: 35220448
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Impact:
Abstract

Complex vs. non-complex percutaneous coronary intervention with newer-generation drug-eluting stents: an analysis from the randomized BIOFLOW trials.

Hemetsberger R, Abdelghani M, Toelg R, Garcia-Garcia HM, ... Waksman R, Richardt G
Background
Patients undergoing complex percutaneous coronary intervention (PCI) are at higher risk of adverse outcomes, but data are scarce in the era of newer-generation coronary stents.
Aim
We sought to compare the clinical outcomes after complex PCI with a bioresorbable-polymer sirolimus-eluting stent (BP-SES) versus a durable-polymer everolimus-eluting stent (DP-EES).
Methods
Patients (n = 2350) from BIOFLOW-II, -IV, and -V randomized trials were categorized into non-complex PCI vs. complex PCI. Complex PCI had at least one of the following criteria: multi-vessel PCI, ≥ 3 lesions treated, ≥ 3 stents implanted, total stent length ≥ 60 mm. Endpoints were target lesion failure (TLF: cardiac death, target-vessel myocardial infarction [TV-MI], or target lesion revascularization [TLR]) and probable/definite stent thrombosis (ST) at three years.
Results
Patients with complex PCI (n = 348) were older and presented more often with acute coronary syndrome than non-complex PCI patients (n = 2002). Complex PCI lesions were more often type B2/C and bifurcation lesions and required more pre- and post-dilatation. Complex PCI patients had higher rates of TLF (14.6% vs. 8.1%; aHR 1.89, 95% CI [1.31-2.73], p = 0.001), TV-MI (10.2% vs. 4.4%, aHR 2.17, 95% CI [1.40-3.37], p = 0.001), and ST (1.5% vs. 0.4%, p = 0.025) as compared with non-complex PCI. TLF was not lower with BP-SES as compared to DP-EES in complex PCI (12.6% vs 18.2%, p = 0.16).
Conclusion
Patients undergoing complex PCI with the newer-generation DES still sustain a higher risk of TLF, TV-MI and stent thrombosis as compared with non-complex PCI. This adverse outcome was not significantly modified by the stent platform (BP-SES vs. DP-EES).
Clinical trial registration
Clinicaltrial.gov NCT01356888, NCT01939249, NCT02389946, https://clinicaltrials.gov/show/NCT01356888 ; https://clinicaltrials.gov/show/NCT01939249 ; https://clinicaltrials.gov/show/NCT02389946 .

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

Clin Res Cardiol: 24 Feb 2022; epub ahead of print
Hemetsberger R, Abdelghani M, Toelg R, Garcia-Garcia HM, ... Waksman R, Richardt G
Clin Res Cardiol: 24 Feb 2022; epub ahead of print | PMID: 35212802
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Impact:

This program is still in alpha version.