Reframing Optimal Implantation of the Sapien 3 Transcatheter Heart Valve.

OBJECTIVES: To define the optimal implantation of the Sapien 3 (Edwards Lifesciences) transcatheter heart valve (THV), this study systematically analyzed the predeployment fluoroscopic THV position and correlated this to clinical outcomes. METHODS: This was an observational study of 279 patients treated with the Sapien 3 THV. Fluoroscopic imaging was used to categorize patients into low (n = 147), intermediate (n = 86), and high (n = 46) implantation zones. These zones were based on the relationship of the balloon marker and radiolucent line of the valve frame (line of lucency) to the annular plane at deployment. The primary outcome was the rate of permanent pacemaker implantation (PPI) at 30 days. The secondary outcomes were the rates of new left bundle-branch block (LBBB) in-hospital and all-cause mortality at 1 year. RESULTS: In the high, intermediate, and low groups, 30-day PPI rates were 4.3%, 8.1%, and 8.8% (P=.62); in-hospital LBBB rates were 10.9%, 26.7%, and 32.0% (P=.02); and all-cause mortality rates at 1 year were 3.1%, 7.3%, and 12.5% (P=.14), respectively. No differences were observed with respect to procedural success/complications or THV performance between the groups. CONCLUSION: This study demonstrates fewer conduction abnormalities for Sapien 3 valves positioned within a higher zone defined fluoroscopically by the line of lucency and balloon marker.

Advances in Clinical Cardiology 2020: A Summary of Key Clinical Trials.

INTRODUCTION: Despite the challenge of a global pandemic, 2020 has been an invaluable year in cardiology research with numerous important clinical trials published or presented virtually at major international meetings. This article aims to summarise these trials and place them in clinical context. METHODS: The authors reviewed clinical trials presented at major cardiology conferences during 2020 including the American College of Cardiology, European Association for Percutaneous Cardiovascular Interventions, European Society of Cardiology, Transcatheter Cardiovascular Therapeutics and the American Heart Association. Trials with a broad relevance to the cardiology community and those with potential to change current practice were included. RESULTS: A total of 87 key cardiology clinical trials were identified for inclusion. New interventional and structural cardiology data included trials evaluating bifurcation percutaneous coronary intervention (PCI) techniques, intravascular ultrasound (IVUS)-guided PCI, instantaneous wave-free (iFR) physiological assessment, new generation stents (DynamX bioadaptor), transcatheter aortic valve implantation (TAVI) in low-risk patients, and percutaneous mitral or tricuspid valve interventions. Preventative cardiology data included new data with proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors (evolocumab and alirocumab), omega-3 supplements, evinacumab and colchicine in the setting of chronic coronary artery disease. Antiplatelet data included trials evaluating both the optimal length of course following PCI and combination of antiplatelet agents and regimes including combination antithrombotic therapies for patients with atrial fibrillation (AF). Heart failure data included the use of sodium-glucose cotransporter 2 (SGLT2) inhibitors (sotagliflozin, empagliflozin and dapagliflozin) and mavacamten in hypertrophic cardiomyopathy. Electrophysiology trials included early rhythm control in AF and screening for AF. CONCLUSION: This article presents a summary of key clinical cardiology trials during the past year and should be of relevance to both clinicians and cardiology researchers.

Massive Left Atrial Myxoma Presenting With Troponin-Positive Chest Pain.

Atrial myxomas are the most prevalent primary cardiac tumors. The clinical presentation is variable and often poses a diagnostic challenge. Here we describe the case of a 52-year-old woman who presented with troponin-positive chest pain, exertional dizziness, and dyspnea as a consequence of a massive left atrial myxoma, which was successfully treated with surgical resection.

The prognostic role of mid-range ejection fraction in ST-segment elevation myocardial infarction.

OBJECTIVE: There is a paucity of studies investigating the impact of mid-range ejection fraction (mrEF) on clinical outcomes, including ventricular arrhythmias, in ST-segment-elevation myocardial infarction (STEMI). We sought to investigate the prognostic role of mrEF post STEMI and whether recommended medical therapy may modify future risk. METHODS: 533 consecutive patients from a single large-volume centre who underwent primary percutaneous coronary intervention were included. Reduced EF (<40%), mrEF (40-49%) and preserved EF (≥50%) were defined according to the European Society of Cardiology guidelines. Clinical outcomes were prospectively collected, and the primary endpoint was defined as the composite of death, re-admission with heart failure, sustained ventricular arrhythmia requiring hospitalisation or implantable cardioverter defibrillator over three years follow-up. RESULTS: There was a stepwise increase in the primary endpoint according to EF group (8%, 17%, 30%, P < .001), which was derived from each individual component. Compared to preserved EF, patients with mrEF had significantly higher risk [HR 4.08 (95%CI 2.38 to 6.99), P < .001]. The use of suboptimal medical therapy was associated with increased future risk, particularly in mrEF [HR 2.62, (95%CI 1.18 to 5.83), P = .018]. The proportion of mrEF patients who experience the primary endpoint was significantly different according the status of kidney function and recommended medical therapy (8%, 20%, 33%, 50%, P < .001). CONCLUSIONS: Patients presenting with mrEF following STEMI had increased risk of death, heart failure hospitalisation and ventricular arrhythmias compared to preserved EF. Suboptimal medical therapy in mrEF was associated with increased adverse events, particularly in patients with renal dysfunction.

Advances in Clinical Cardiology 2019: A Summary of Key Clinical Trials.

INTRODUCTION: A large number of important clinical trials in cardiology were published or presented at major international conferences during 2019. This paper aims to offer a concise overview of these significant advances and to put them into clinical context. METHODS: Trials presented at the major international cardiology meetings during 2019 were reviewed including The American College of Cardiology (ACC), Euro PCR, The European Society of Cardiology (ESC), Transcatheter Cardiovascular Therapeutics (TCT), and the American Heart Association (AHA). In addition to this a literature search identified several other publications eligible for inclusion based on their relevance to clinical cardiology, their potential impact on clinical practice and on future guidelines. RESULTS: A total of 70 trials met the inclusion criteria. New interventional and structural data include trials examining use of drug-coated balloons in patients with acute myocardial infarction (MI), interventions following shockable cardiac arrest, mechanical circulatory support in cardiogenic shock complicating MI, intervention in stable coronary artery disease, surgical or percutaneous revascularisation strategies in left main coronary artery disease, revascularisation strategy in ST elevation MI, transcatheter aortic valve replacement in low-risk patients, and percutaneous mitral or tricuspid valve interventions. Preventative cardiology data included the use of sodium-glucose cotransporter 2 (SGLT2) inhibitors (dapagliflozin), proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors (evolocumab), bempedoic acid, and novel approaches to the management of hypertension. Antiplatelet data included trials evaluating both the optimal length of course and combination of antiplatelet agents and regimes including combination antithrombotic therapies for patients with atrial fibrillation. Heart failure data included trials of sacubitril-valsartan in heart failure with preserved ejection fraction and the use of SGLT2 inhibitors in patients with heart failure but without diabetes. Electrophysiology data included trials examining alcohol in atrial fibrillation and the use of wearable fitness devices for identifying atrial fibrillation. CONCLUSION: This article presents key clinical trials completed during 2019 and should be valuable to clinicians and researchers working in cardiology.

Comparative Analysis of the Effect of Renal Function on the Spectrum of Coronary Artery Disease.

BACKGROUND: We aim to assess the differential effect of renal impairment across the spectrum of patients with ischaemic heart disease and to study if any established risk factors may modify this risk. METHODS: A total of 2013 patients who underwent revascularization for ST-segment elevation myocardial infarction or invasive physiology assessment were included. Renal impairment was defined as glomerular filtration rate less than 60 ml/min/1.73m2. Clinical endpoints were prospectively collected, and the primary endpoint was defined as the composite endpoints of death, myocardial infarction, and unplanned revascularization. RESULTS: 593 (30%) presented with ST-segment elevation myocardial infarction, and 1362 (70%) stable patients had invasive ischaemia assessment which resulted in 37% receiving revascularization and 63% being deferred. Renal impairment was associated with increased adverse events in myocardial infarction [HR 1.77 (95% CI 1.15 to 2.74)], but not in the revascularized stable group [(HR 1.14 (95% CI 0.62 to 2.08)] or the deferred group [HR 1.31 (95% CI 0.84 to 2.03)]. There was an exponential increase in the future risk in ST-segment elevation myocardial infarction patients with severe renal dysfunction (glomerular filtration rate < 30) compared to a linear relationship in stable patients. Age and hypertension were the only two factors that had a differential impact across three groups (P<0.05 for interactions), with inconsistent directional effect of hypertension between medically managed and revascularized groups. CONCLUSIONS: The magnitude of risk of renal impairment varies according to the clinical presentation of coronary artery disease with more weighted risk in myocardial infarction compared to stable patients.

Clinical Outcomes of Deferred Revascularisation Using Fractional Flow Reserve in Diabetic Patients.

BACKGROUND: Fractional flow reserve (FFR) is used to assess the functional significance of coronary artery lesions. Diabetic patients are associated with high burden of atherosclerosis and microvascular dysfunction. We studied the clinical outcomes of diabetic patients who underwent FFR-guided deferred revascularisation. METHODS: Consecutive patients from a single large volume centre who underwent FFR assessment were included. Clinical endpoints were prospectively collected using the national electronic care records system. The primary endpoint was defined as the four-year risk of the vessel-oriented composite outcome of cardiac death, vessel-related myocardial infarction (VMI), and vessel-related urgent revascularisation (VUR). Absolute FFR values groups (0.81 to 0.85; 0.86 to 0.90; and >0.90) were used to further stratify patient outcomes. RESULTS: FFR-guided deferred revascularisation occurred in 860 patients (63%), of whom 159 were diabetic. The primary endpoint was significantly higher in the diabetic compared to the non-diabetic group [HR 1.76 (95%CI 1.08 to 2.88), P = 0.024]. The difference was driven from cardiac death (6.3% vs. 3.0%, P = 0.044) and VMI (5.0% vs. 1.7%, P = 0.012) but not VUR (8.8% vs. 5.1%, P = 0.07). There was a significant decrease in the incidence of the primary endpoint in the diabetic group according to FFR groups (23.6%, 12.3%, 2.4%, P = 0.001) with comparable clinical outcomes in the non-diabetic group (11.8%, 6.4%, 7.4%, P = 0.085). CONCLUSIONS: Our study demonstrated an increased risk of death and target vessel MI in diabetic patients undergoing FFR-guided deferred revascularisation compared to non-diabetic group. Nonetheless, FFR remained a useful tool to identify those at future risk, mainly in diabetic patients.

Eosinopenia as an Adverse Marker of Clinical Outcomes in Patients Presenting with Acute Myocardial Infarction.

BACKGROUND: Eosinopenia is considered a surrogate of inflammation in several disease settings. Following ST-segment elevation myocardial infarction, eosinopenia is presumed to be a marker of infarct severity. We sought to study the relationship between eosinopenia and infarct severity and how this relationship determined the long-term outcomes following ST-segment elevation myocardial infarction. METHODS: Six hundred and six consecutive patients undergoing primary percutaneous coronary interventions from a large volume single center were enrolled. Low eosinophil count was defined as < 40 cells/mL from samples within 2 hours after reperfusion. Primary endpoint was defined as composite of death, myocardial infarction, stroke, unplanned revascularization, and readmission for heart failure over 3.5 years' follow-up. RESULTS: Sixty-five percent of the patients had eosinopenia. Patients in the low eosinophil group had larger infarct size as measured by troponin value (2934 vs 1177 ng/L, P < .001) and left ventricle systolic function on echocardiography (48% vs 50%, P = 0.029). There was a weak correlation between eosinophil count and both troponin (r = -0.25, P < 0.001) and ejection fraction (r = 0.10, P = .017). The primary endpoint was higher in eosinopenic patients (28.8% vs. 20.4%; hazard ratio [HR] 1.49, 95% confidence interval [CI] 1.05 to 2.13, P = .023). A discordance between eosinopenia and severe left ventricle systolic dysfunction was observed in 55.6% of cases. Compared with normal count, eosinopenia was associated with worse clinical outcomes in patients with non-severe left ventricle dysfunction (24.1% vs 16.2%; HR 1.58, 95% CI 1.01 to 2.45, P = .044) but not in those with severe left ventricle dysfunction (42.3% vs. 38.9%; HR 1.10, 95% CI 0.59 to 2.03, P = .77) (P < .01 for interaction). CONCLUSIONS: Eosinopenia is an easily determined marker that reflects worse clinical outcomes over long-term follow-up.

Advances in Clinical Cardiology 2017: A Summary of Key Clinical Trials.

INTRODUCTION: Numerous important cardiology clinical trials have been published or presented at major international meetings during 2017. This paper aims to summarize these trials and place them in clinical context. METHODS: The authors reviewed clinical trials presented at major cardiology conferences during 2017 including the American College of Cardiology, European Association for Percutaneous Cardiovascular Interventions, European Society of Cardiology, European Association for the Study of Diabetes, Transcatheter Cardiovascular Therapeutics, and the American Heart Association. Selection criteria were trials with a broad relevance to the cardiology community and those with potential to change current practice. RESULTS: A total of 75 key cardiology clinical trials were identified for inclusion. New interventional and structural cardiology data include left main bifurcation treatment strategy, multivessel disease management in cardiogenic shock, drug-eluting balloons for in-stent restenosis, instantaneous wave-free physiological assessment, new-generation stents (COMBO, Orsiro), transcatheter aortic valve implantation, and closure devices. New preventative cardiology data include trials of liraglutide, empagliflozin, PCSK9 inhibitors (evolocumab and bococizumab), inclisiran, and anacetrapib. Antiplatelet data include the role of uninterrupted aspirin therapy during non-cardiac surgery and dual antiplatelet therapy following coronary artery bypass grafting. New data are also included from fields of heart failure (levosimendan, spironolactone), atrial fibrillation (apixaban in DC cardioversion), cardiac devices (closed loop stimulation pacing for neuromediated syncope), and electrophysiology (catheter ablation for atrial fibrillation). CONCLUSION: This paper presents a summary of key clinical cardiology trials during the past year and should be of practical value to both clinicians and cardiology researchers.

New low-temperature applications of anaerobic wastewater treatment.

Low-temperature or psychrophilic (<20 degrees C) anaerobic biological treatment of simple industrial wastewaters has recently been proven feasible as an alternative to more expensive mesophilic (ca. 37 degrees C) technology. We implemented novel expanded granular sludge bed (EGSB)-based bioreactor designs for 27 psychrophilic anaerobic digestion (PAD) trials for the treatment of a broad range of simple and complex synthetic wastewaters representing dairy, food-processing and pharmaceutical sector effluents. A variety of operating parameters, such as hydraulic retention time, organic and volumetric loading rates and upflow velocity, were tested. Chemical oxygen demand (COD) removal efficiencies were recorded, which were comparable to previous mesophilic trials. Specific methanogenic activity, toxicity and biodegradability batch assays were employed to monitor the metabolic capabilities of microbial consortia in anaerobic reactors. The prevalence of psychrotolerant communities was observed and psychrophilic populations were detected in two of the reactors. The potential of PAD with respect to global sustainable development is discussed.

Accessing the black box of microbial diversity and ecophysiology: recent advances through polyphasic experiments.

The microbial ecology of a range of anaerobic biological assemblages (granular sludge) from full- and laboratory-scale wastewater treatment bioreactors, and of crop-growing and peat soils, was determined using a variety of 16S rRNA gene-based techniques, including clone library, terminal restriction fragment length polymorphism (TRFLP) and denaturing gradient gel electrophoresis (DGGE) analyses. Fluorescent in situ hybridization (FISH) using 16S rRNA gene-targeted probes was employed to complete a "full-cycle rRNA approach" with selected biomass. Genetic fingerprinting (TRFLP and DGGE) was effectively used to elucidate community structure-crop relationships, and to detect and monitor trends in bioreactor sludge and specific enrichment cultures of peat soil. Greater diversity was resolved within bacterial than within archaeal communities, and unexpected reservoirs of uncultured Crenarchaeota were detected in sludge granules. Advanced radiotracer incubations and micro-beta imaging were employed in conjunction with FISH to elucidate the eco-functionalism of these organisms. Crenarchaeota clusters were identified in close associated with methanogenic Archaea and both were localised with acetate uptake in biofilm structure.