Showing papers in "Clinical Research in Cardiology in 2022"
TL;DR: In this article , the authors describe the autopsy findings and common characteristics of myocarditis in untreated persons who received anti-SARS-CoV-2 vaccination, and they suggest that mild myocyte damage may cause death due to arrhythmogenic cardiac failure.
Abstract: Abstract Cases of myocarditis, diagnosed clinically by laboratory tests and imaging have been described in the context of mRNA-based anti-SARS-CoV-2 vaccination. Autopsy-based description of detailed histological features of vaccine-induced myocarditis is lacking. We describe the autopsy findings and common characteristics of myocarditis in untreated persons who received anti-SARS-CoV-2 vaccination. Standardized autopsies were performed on 25 persons who had died unexpectedly and within 20 days after anti-SARS-CoV-2 vaccination. In four patients who received a mRNA vaccination, we identified acute (epi-)myocarditis without detection of another significant disease or health constellation that may have caused an unexpected death. Histology showed patchy interstitial myocardial T-lymphocytic infiltration, predominantly of the CD4 positive subset, associated with mild myocyte damage. Overall, autopsy findings indicated death due to acute arrhythmogenic cardiac failure. Thus, myocarditis can be a potentially lethal complication following mRNA-based anti-SARS-CoV-2 vaccination. Our findings may aid in adequately diagnosing unclear cases after vaccination and in establishing a timely diagnosis in vivo, thus, providing the framework for adequate monitoring and early treatment of severe clinical cases. Graphical abstract
34 citations
TL;DR: In this paper , the authors analyzed the rates of myocarditis after COVID-19 infection and COVID19 vaccination in Hong Kong, compared to the background rates, and compared the rate of myopericarditis after the vaccination to those reported in other countries.
Abstract: 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.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.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.COVID-19 infection was associated with significantly higher rate of myopericarditis compared to the vaccine-associated myopericarditis.
19 citations
TL;DR: In this article , the authors examined the time course of dispensed packages between January 2016 and December 2020 and found that 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.
Abstract: Abstract 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. Graphical abstract
13 citations
TL;DR: In this paper , the authors 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.
Abstract: Abstract 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. Graphical abstract Typical data flow in machine learning applications for atrial fibrillation detection.
12 citations
TL;DR: In this article , 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.
Abstract: Abstract 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. Graphical abstract
10 citations
TL;DR: In this paper , the authors identify pre-ablation serum biomarker(s) associated with arrhythmia recurrence to improve patient selection before catheter ablation (CA).
Abstract: A high proportion of patients undergoing catheter ablation (CA) for atrial fibrillation (AF) experience recurrence of arrhythmia. This meta-analysis aims to identify pre-ablation serum biomarker(s) associated with arrhythmia recurrence to improve patient selection before CA.A systematic approach following PRISMA reporting guidelines was utilised in libraries (Pubmed/Medline, Embase, Web of Science, Scopus) and supplemented by scanning through bibliographies of articles. Biomarker levels were compared using a random-effects model and presented as odds ratio (OR). Heterogeneity was examined by meta-regression and subgroup analysis.In total, 73 studies were identified after inclusion and exclusion criteria were applied. Nine out of 22 biomarkers showed association with recurrence of AF after CA. High levels of N-Terminal-pro-B-type-Natriuretic Peptide [OR (95% CI), 3.11 (1.80-5.36)], B-type Natriuretic Peptide [BNP, 2.91 (1.74-4.88)], high-sensitivity C-Reactive Protein [2.04 (1.28-3.23)], Carboxy-terminal telopeptide of collagen type I [1.89 (1.16-3.08)] and Interleukin-6 [1.83 (1.18-2.84)] were strongly associated with identifying patients with AF recurrence. Meta-regression highlighted that AF type had a significant impact on BNP levels (heterogeneity R2 = 55%). Subgroup analysis showed that high BNP levels were more strongly associated with AF recurrence in paroxysmal AF (PAF) cohorts compared to the addition of non-PAF patients. Egger's test ruled out the presence of publication bias from small-study effects.Ranking biomarkers based on the strength of association with outcome provides each biomarker relative capacity to predict AF recurrence. This will provide randomised controlled trials, a guide to choosing a priori tool for identifying patients likely to revert to AF, which are required to substantiate these findings.
10 citations
TL;DR: A comprehensive and structured review of existing venting modalities and their specific hemodynamic characteristics is provided in this article , where the available data on outcome categories and complication rates related to the respective venting option are discussed in detail.
Abstract: Cardiogenic shock and cardiac arrest contribute pre-dominantly to mortality in acute cardiovascular care. Here, veno-arterial extracorporeal membrane oxygenation (VA-ECMO) has emerged as an established therapeutic option for patients suffering from these life-threatening entities. VA-ECMO provides temporary circulatory support until causative treatments are effective and enables recovery or serves as a bridging strategy to surgical ventricular assist devices, heart transplantation or decision-making. However, in-hospital mortality rate in this treatment population is still around 60%. In the recently published ARREST trial, VA-ECMO treatment lowered mortality rate in patients with ongoing cardiac arrest due to therapy refractory ventricular fibrillation compared to standard advanced cardiac life support in selected patients. Whether VA-ECMO can reduce mortality compared to standard of care in cardiogenic shock has to be evaluated in the ongoing prospective randomized studies EURO-SHOCK (NCT03813134) and ECLS-SHOCK (NCT03637205). As an innate drawback of VA-ECMO treatment, the retrograde aortic flow could lead to an elevation of left ventricular (LV) afterload, increase in LV filling pressure, mitral regurgitation, and elevated left atrial pressure. This may compromise myocardial function and recovery, pulmonary hemodynamics-possibly with concomitant pulmonary congestion and even lung failure-and contribute to poor outcomes in a relevant proportion of treated patients. To overcome these detrimental effects, a multitude of venting strategies are currently engaged for both preventive and emergent unloading. This review aims to provide a comprehensive and structured synopsis of existing venting modalities and their specific hemodynamic characteristics. We discuss in detail the available data on outcome categories and complication rates related to the respective venting option.
10 citations
TL;DR: In this paper , a systematic review and meta-analysis is performed to investigate the rates of carditis in children and adolescents receiving COVID-19 vaccines. But, the authors did not investigate the risk of these events in the global setting.
Abstract: Coronavirus Disease-2019 (COVID-19) vaccination has been associated with the development of carditis, especially in children and adolescent males. However, the rates of these events in the global setting have not been explored in a systematic manner. The aim of this systematic review and meta-analysis is to investigate the rates of carditis in children and adolescents receiving COVID-19 vaccines.PubMed, Embase and several Latin American databases were searched for studies. The number of events, and where available, at-risk populations were extracted. Rate ratios were calculated and expressed as a rate per million doses received. Subgroup analysis based on the dose administered was performed. Subjects ≤ 19 years old who developed pericarditis or myocarditis following COVID-19 vaccination were included.A total of 369 entries were retrieved. After screening, 39 articles were included. Our meta-analysis found that 343 patients developed carditis after the administration of 12,602,625 COVID-19 vaccination doses (pooled rate per million: 37.76; 95% confidence interval [CI] 23.57, 59.19). The rate of carditis was higher amongst male patients (pooled rate ratio: 5.04; 95% CI 1.40, 18.19) and after the second vaccination dose (pooled rate ratio: 5.60; 95% CI 1.97, 15.89). In 301 cases of carditis (281 male; mean age: 15.90 (standard deviation [SD] 1.52) years old) reported amongst the case series/reports, 261 patients were reported to have received treatment. 97.34% of the patients presented with chest pain. The common findings include ST elevation and T wave abnormalities on electrocardiography. Oedema and late gadolinium enhancement in the myocardium were frequently observed in cardiac magnetic resonance imaging (CMR). The mean length of hospital stay was 3.91 days (SD 1.75). In 298 out of 299 patients (99.67%) the carditis resolved with or without treatment.Carditis is a rare complication after COVID-19 vaccination across the globe, but the vast majority of episodes are self-limiting with rapid resolution of symptoms within days. Central illustration. Balancing the benefits of vaccines on COVID-19-caused carditis and post-vaccination carditis.
9 citations
TL;DR: In this article , the authors performed a random-effects meta-analysis of controlled studies (PERT vs. pre-PERT era) to investigate the impact of PERTs on clinical outcomes and advanced therapies use.
Abstract: Abstract Background Over the last years, multidisciplinary pulmonary embolism response teams (PERTs) have emerged to encounter the increasing variety and complexity in the management of acute pulmonary embolism (PE). We aimed to systematically investigate the composition and added clinical value of PERTs. Methods We searched PubMed, CENTRAL and Web of Science until January 2022 for articles designed to describe the structure and function of PERTs. We performed a random-effects meta-analysis of controlled studies (PERT vs. pre-PERT era) to investigate the impact of PERTs on clinical outcomes and advanced therapies use. Results We included 22 original studies and four surveys. Overall, 31.5% of patients with PE were evaluated by PERT referred mostly by emergency departments (59.4%). In 11 single-arm studies (1532 intermediate-risk and high-risk patients evaluated by PERT) mortality rate was 10%, bleeding rate 9% and length of stay 7.3 days [95% confidence interval (CI) 5.7–8.9]. In nine controlled studies there was no difference in mortality [risk ratio (RR) 0.89, 95% CI 0.67–1.19] by comparing pre-PERT with PERT era. When analysing patients with intermediate or high-risk class only, the effect estimate for mortality tended to be lower for patients treated in the PERT era compared to those treated in the pre-PERT era (RR 0.71, 95% CI 0.45–1.12). The use of advanced therapies was higher (RR 2.67, 95% CI 1.29–5.50) and the in-hospital stay shorter (mean difference − 1.6 days) in PERT era compared to pre-PERT era. Conclusions PERT implementation led to greater use of advanced therapies and shorter in-hospital stay. Our meta-analysis did not show a survival benefit in patients with PE since PERT implementation. Large prospective studies are needed to further explore the impact of PERTs on clinical outcomes. Registration Open Science Framework 10.17605/OSF.IO/SBFK9. Graphical abstract
9 citations
TL;DR: PASSPORT-HF as discussed by the authors is a prospective, randomized, open, multicenter trial evaluating the effects of a hemodynamic-guided, heart failure nurse-led care approach using the CardioMEMS™ HF-System on clinical end points.
Abstract: 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.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.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.PASSPORT-HF will define the efficacy of implementing hemodynamic monitoring as a novel disease management tool in routine outpatient care.ClinicalTrials.gov; NCT04398654, 13-MAY-2020.
8 citations
TL;DR: In this paper , the authors evaluated efficacy, safety and follow-up of pulsed-field ablation-based pulmonary vein isolation (PVI) in an early adopter routine care setting.
Abstract: Pulsed-field ablation (PFA) is a new energy source to achieve pulmonary vein isolation (PVI) by targeted electroporation of cardiomyocytes. Experimental and controlled clinical trial data suggest good efficacy of PFA-based PVI. We aimed to assess efficacy, safety and follow-up of PFA-based PVI in an early adopter routine care setting.Consecutive patients with symptomatic paroxysmal or persistent atrial fibrillation (AF) underwent PVI using the Farawave® PFA ablation catheter in conjunction with three-dimensional mapping at two German high-volume ablation centers. PVI was achieved by applying 8 PFA applications in each PV.A total of 138 patients undergoing a first PVI (67 ± 12 years, 66% male, 62% persistent AF) were treated. PVI was achieved in all patients by deploying 4563 applications in 546 PVs (8.4 ± 1.0/PV). Disappearance of PV signals after the first application was demonstrated in 544/546 PVs (99.6%). More than eight PFA applications were performed in 29/546 PVs (6%) following adapted catheter positioning or due to reconnection as assessed during remapping. Mean procedure time was 78 ± 22 min including pre- and post PVI high-density voltage mapping. PFA catheter LA dwell-time was 23 ± 9 min. Total fluoroscopy time and dose area product were 16 ± 7 min and 505 [275;747] cGy*cm2. One pericardial tamponade (0.7%), one transient ST-elevation (0.7%) and three groin complications (2.2%) occurred. 1-year follow-up showed freedom of arrhythmia in 90% in patients with paroxysmal AF (n = 47) and 60% in patients with persistent AF (n = 82, p = 0.015).PFA-based PVI is acutely highly effective and associated with a beneficial safety and low recurrence rate.
TL;DR: In this paper , the authors evaluated the evolution and impact of mitral regurgitation (MR) severity with guideline-recommended medical therapy (GRMT) in heart failure (HF).
Abstract: Abstract 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. Graphical abstract
TL;DR: Patients undergoing complex percutaneous coronary intervention with the newer-generation DES still sustain a higher risk of TLF, TV-MI and stent thrombosis as compared with non-complex PCI.
TL;DR: In this article , the authors examined 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.
Abstract: 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.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.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.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.
TL;DR: In this article , the authors compared the hemodynamic characteristics of different self-expanding (SE) and balloon-expandable (BE) transcatheter heart valves (THV) in relation to native aortic annulus anatomy.
Abstract: Abstract Objectives This study aimed to compare hemodynamic characteristics of different self-expanding (SE) and balloon-expandable (BE) transcatheter heart valves (THV) in relation to native aortic annulus anatomy. Background A patient centered THV selection becomes increasingly important as indications for transcatheter aortic valve replacement (TAVR) are extended towards lower risk populations. Methods Hemodynamic parameters including mean gradient (MG), effective orifice area (EOA), Doppler velocity index (DVI), degree of paravalvular regurgitation (PVR) and patient-prosthesis mismatch (PPM) were compared by valve type, label size and in relation to quintiles of native aortic annulus area. Results 2609 patients were treated at 3 centers in Germany with SAPIEN 3 ( n = 1146), ACURATE Neo ( n = 649), Evolut R ( n = 546) or Evolut Pro ( n = 268) THV. SE THVs provided superior hemodynamics in terms of larger EOA, higher DVI and lower MG compared to BE THV, especially in patients with small aortic annuli. Severe PPM was less frequent in SE treated patients. The rate of PVR ≥ moderate was comparable for SE and BE devices in smaller annular dimensions, but remarkably lower for BE TAVR in large aortic annular dimensions (> 547.64 mm 2 ) (2% BE THV vs. > 10% for SE THV; p < 0.001). Conclusions Patients with small aortic annular dimensions may benefit hemodynamically from SE THV. With increasing annulus size, BE THV may have advantages since PVR ≥ moderate occurs less frequently. Graphical abstract
TL;DR: In this article , the authors presented 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.
Abstract: 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.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).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).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.
TL;DR: In this paper , the effectiveness and safety of NOACs in patients with newly diagnosed atrial fibrillation (AF) were compared on the GLORIA-AF Phase III registry.
Abstract: Abstract 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. Graphical abstract
TL;DR: In this article , the authors provide an update of survey-based data providing an overview of interventional electrophysiology over the last decade and assess the infrastructure, procedures, and training opportunities in Germany.
Abstract: This study provides an update of survey-based data providing an overview of interventional electrophysiology over the last decade. Overall infrastructure, procedures, and training opportunities in Germany were assessed.By analyzing mandatory quality reports, German cardiology centres performing electrophysiological studies were identified to repeat a questionnaire from 2010 and 2015.A complete questionnaire was returned by 192 centers performing about 75% of all ablations in Germany in 2020. In the presence of the COVID-19 pandemic, a total of 76.304 procedures including 68.407 ablations were reported representing a 38% increase compared to 2015. The median number of ablations increased from 180 in 2010 to 377 in 2020. AF was the most common arrhythmia ablated (51 vs. 35% in 2010). PVI with radiofrequency point-by-point ablation (64%) and cryo-balloon ablation (34%) were the preferred strategies. Less than 50 (75) PVI were performed by 31% (36%) of all centres. Only 25 and 24% of participating centres fulfilled EHRA and national requirements for training centre accreditation, respectively. There was a high number of EP centres with no fellows (38%). The proportion of female fellows in EP increased from 26% in 2010 to 33% in 2020.Comparing 2020, 2010 and 2015, an increasing number of EP centres and procedures were registered. In 2020, more than every second ablation was for therapy of AF. In the presence of an increasing number of procedures, training opportunities were still limited, and most centres did not fulfill recommended EHRA or national requirements for accreditation.
TL;DR: In this article , the outcomes of cardiac patients whose non-emergency interventions had been deferred during the COVID-19 pandemic were assessed and compared to a seasonal control group who underwent non-EM interventions in 2019 as scheduled.
Abstract: 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.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.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.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.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.
TL;DR: In this paper , the authors evaluated the safety and efficacy of renal denervation up to five years taking into account anti-hypertensive drug regimen changes over time, and showed that the RDN significantly lower blood pressure (BP) at 2-6 months.
Abstract: Renal denervation (RDN) proved to significantly lower blood pressure (BP) at 2-6 months in patients on and off antihypertensive drugs. Given a lack of longer-term follow-up data, our aim was to assess the safety and efficacy of RDN up to five years taking into account antihypertensive drug regimen changes over time.In the present single-center study, patients underwent RDN for (therapy resistant) hypertension. Patients underwent protocolized yearly follow-up out to five years. Data were collected on 24-h ambulatory BP and office BP monitoring, renal function, antihypertensive drug regimen, and safety events, including non-invasive renal artery imaging at 6/12 months. Efficacy analyses were performed using linear mixed-effects models.Seventy-two patients with mean age 63.3 ± 9.5 (SD) years (51% female) were included. Median follow-up time was 3.5 years and Clark's Completeness Index was 72%. Baseline ambulatory daytime BP was 146.1/83.7 ± 17.4/12.2 mmHg under a mean number of 4.9 ± 2.7 defined daily doses (DDD). At five years, ambulatory daytime systolic BP as calculated from the mixed model was 120.8 (95% CI 114.2-127.5) mmHg and diastolic BP was 73.3 (95% CI 69.4-77.3) mmHg, implying a reduction of -20.9/-8.3 mmHg as compared to baseline estimates (p < 0.0001). The number of DDDs remained stable over time (p = 0.87). No procedure-related major adverse events resulting in long-term consequences were observed.The BP-lowering effect of RDN was safely maintained at least five years post-procedure as reflected by a significant decrease in ambulatory daytime BP in the absence of escalating antihypertensive drug therapy over time.
TL;DR: 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.
TL;DR: In this article , the authors compared the safety and effectiveness of dabigatran versus vitamin K antagonists (VKAs) in patients with newly diagnosed atrial fibrillation (AF) patients.
Abstract: 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.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.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.gov . NCT01468701, NCT01671007.
TL;DR: In this paper , the effects of early AF ablation compared to medical therapy were evaluated using data from phase II/III of the GLORIA-AF registry, where patients who were consecutively enrolled with newly diagnosed AF (< 3 months before baseline visit) and an increased risk of stroke (CHA2DS2-VASc ≥ 1).
Abstract: 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.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.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.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.Clinical trial registration: http://www.gov . Unique identifiers: NCT01468701, NCT01671007 and NCT01937377. Created with BioRender.com.
TL;DR: In this paper , the authors conducted an observational study on hospital routine data (§21 KHEntgG) and included patients with the main diagnosis of acute myocardial infarction (ICD 21 and ICD 22).
Abstract: Reports about the influence of the COVID-19 pandemic on the number of hospital admissions and in-hospital mortality during the first wave between March and May 2020 showed conflicting results and are limited by single-center or limited regional multicenter datasets. Aim of this analysis covering all German federal states was the comprehensive description of hospital admissions and in-hospital mortality during the first wave of the COVID-19 pandemic.We conducted an observational study on hospital routine data (§21 KHEntgG) and included patients with the main diagnosis of acute myocardial infarction (ICD 21 and ICD 22). A total of 159 hospitals included 36,329 patients in the database, with 12,497 patients admitted with ST-elevation myocardial infarction (STEMI) and 23,832 admitted with non-ST-elevation myocardial infarction (NSTEMI). There was a significant reduction in the number of patients admitted with STEMI (3748 in 2020, 4263 in 2019 and 4486 in 2018; p < 0.01) and NSTEMI (6957 in 2020, 8437 in 2019 and 8438 in 2020; p < 0.01). These reductions were different between the Federal states of Germany. Percutaneous coronary intervention was performed more often in 2020 than in 2019 (odds ratio 1.13, 95% confidence interval [CI] 1.06-1.21) and 2018 (odds ratio 1.20, 95% CI 1.12-1.29) in NSTEMI and more often than in 2018 (odds ratio 1.26, 95% CI 1.10-1.43) in STEMI. The in-hospital mortality did not differ between the years for STEMI and NSTEMI, respectively.In this large representative sample size of hospitals in Germany, we observed significantly fewer admissions for NSTEMI and STEMI during the first COVID-19 wave, while quality of in-hospital care and in-hospital mortality were not affected. Admissions for STEMI and NSTEMI during the months March to May over 3 years and corresponding in-hospital mortality for patients with STEMI and NSTEMI in 159 German hospitals. (p-value for admissions 2020 versus 2019 and 2018: < 0.01; p-value for mortality: n.s.).
TL;DR: In this paper , the authors compared TAVI vs. SAVR in patients with moderate-to-severe chronic kidney disease (eGFR 15-60 ml/min/1.73 m 2 ) for whom both procedures could possibly be considered.
Abstract: Abstract Objective We compared TAVI vs. SAVR in patients with moderate-to-severe chronic kidney disease (eGFR 15–60 ml/min/1.73 m 2 ) for whom both procedures could possibly be considered (age ≤ 80 years, STS-score 4–8). Background According to both ACC/AHA and ESC/EACTS recent guidelines, aortic stenosis may be treated with either transcatheter (TAVI) or surgical (SAVR) aortic valve replacement in a subgroup of patients. A shared therapeutic decision is made by a heart team based on individual factors, including chronic kidney disease (CKD). Methods Data from the large nationwide German Aortic Valve Registry were used. A propensity score method was used to select 704 TAVI and 374 SAVR matched patients. Primary endpoint was 1-year survival. Secondary endpoints were clinical complications, including pacemaker implantation, vascular complications, myocardial infarction, bleeding, and the need for new-onset dialysis. Results One-year survival was similar (HR [95% CI] for TAVI 1.271 [0.795, 2.031], p = 0.316), with no divergence in Kaplan–Meier curves. In spite of post-procedural short-term survival being numerically higher for TAVI patients and 1-year survival being numerically higher for SAVR patients, such differences did not reach statistical significance (96.4% vs. 94.2%, p = 0.199, and 86.2% vs. 81.2%, p = 0.316, respectively). In weighted analyses, pacemaker implantation, vascular complications, and were significantly more common with TAVI; whereas myocardial infarction, bleeding requiring transfusion, and longer ICU-stay and overall hospitalization were higher with SAVR. Temporary dialysis was more common with SAVR ( p < 0.0001); however, a probable need for chronic dialysis was rare and similar in both groups. Conclusion Both TAVI and SAVR led to comparable and excellent results in patients with moderate-to-severe CKD in an intermediate-risk population of patients with symptomatic severe aortic stenosis for whom both therapies could possibly be considered.
TL;DR: In this paper , a double-blind, randomised (2:1), placebo-controlled, parallel-group, clinical trial, 74 patients with NYHA class II-III chronic heart failure and an ejection fraction of 49% or less received empagliflozin 10 mg once daily or placebo for 3 months.
Abstract: Abstract Introduction Sodium-glucose co-transporter 2 (SGLT2) inhibitors have cardiovascular protective properties in addition to the metabolic effects and represent a cornerstone of treating patients with chronic heart failure (CHF). We hypothesised that empagliflozin reduces tissue sodium content in patients with CHF. Methods In a double-blind, randomised (2:1), placebo-controlled, parallel-group, clinical trial, 74 patients with NYHA class II–III CHF and an ejection fraction of 49% or less received empagliflozin 10 mg once daily or placebo for 3 months. In each patient, tissue sodium content of the lower leg was assessed non-invasively by sodium-MRI ( 23 Na-MRI) at baseline, after 1 and 3 months of treatment. Results After 1 and 3 months treatment with empagliflozin ( n = 48), a significant decrease in skin sodium content was observed (1 month: 22.8 ± 6.1 vs. 21.6 ± 6.0 AU, p = 0.039; 3 months: 22.9 ± 6.1 vs. 21.6 ± 6.1 AU, p = 0.013), while there was no change in muscle sodium and muscle water content. In direct comparison, the change in skin sodium content between baseline and 3 months was − 1.3 ± 3.5 AU in the empagliflozin group versus 0.6 ± 3.5 AU in the placebo group ( p for between-group difference = 0.022). No significant difference regarding change in muscle sodium and in muscle water content was observed after 3 months treatment between the two groups. Conclusion This trial showed a significant decrease in skin sodium content after 1 and 3 months of treatment with empagliflozin. The decrease in skin sodium content may reflect a decrease in subclinical micro-oedema or/and in non-osmotic bound tissue sodium, both reported to impair left ventricular function. Trial registration number NCT03128528 ( http://www.clinicaltrials.gov ). Trial registration date 25th April 2017.
TL;DR: In this paper , the authors characterize different groups of low-flow low-gradient (LFLG) aortic stenosis and determine short-term outcomes and long-term mortality according to VARC-3 endpoint definitions.
Abstract: 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.Characteristics and outcomes of patients with LFLG AS undergoing transcatheter aortic valve implantation (TAVI) are poorly understood.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).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]).While 3-year mortality remains high after TAVI in LFLG compared to HG patients, symptoms improve in all subsets after TAVI.
TL;DR: In this article , a longitudinal observational study examined a group of adults with surgically corrected or palliated congenital heart defects (CHD) during a 15-year period and found that the mortality rate was significantly reduced in patients with severe CHD in comparison to individuals with mild and moderate CHD.
Abstract: 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.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.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).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.
TL;DR: LF detected by FIB-4 score > 3.25 was associated with more severe ACS presentation and worse in-hospital AEs irrespective of clinical and laboratory variables.