Percutaneous mitral valve repair using the MitraClip device has been proposed to correct secondary mitral regurgitation (MR). Recently, the results of two randomized controlled trials, that is ...MITRA-FR (Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation) and COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation), assessing the efficacy and safety of MitraClip in patients with systolic heart failure and severe secondary MR were published. A priori, these two trials targeted the same patient populations with the same disease using the same device but the results of these trials were diametrically opposed, MITRA-FR being neutral and COAPT being highly positive with respect to efficacy of the MitraClip procedure. The objectives of this viewpoint are: (i) to highlight not only the similarities but also the differences between MITRA-FR and COAPT, which may explain the strikingly different results and conclusions between these two trials and (ii) to derive from these results, implications with regards to the application of the MitraClip procedure in clinical practice.
Authors/Task Force Members/Chairpersons Kristian Thygesen∗ (Denmark) Joseph S. Alpert∗ (USA) Allan S. Jaffe (USA) Bernard R. Chaitman (USA) Jeroen J. Bax (the Netherlands) David A. Morrow (USA) ...Harvey D. White∗ (New Zealand) Hans Mickley (Denmark) Filippo Crea (Italy) Frans Van de Werf (Belgium) Chiara Bucciarelli-Ducci (UK) Hugo A. Katus (Germany) Fausto J. Pinto (Portugal) Elliott M. Antman (USA) Christian W. Hamm (Germany) Raffaele De Caterina (Italy) James L. Januzzi Jr (USA) Fred S. Apple (USA) Maria Angeles Alonso Garcia (Spain) S. Richard Underwood (UK) John M. Canty Jr (USA) Alexander R. Lyon (UK) P.J. Devereaux (Canada) Jose Luis Zamorano (Spain) Bertil Lindahl (Sweden) William S. Weintraub (USA) L. Kristin Newby (USA) Renu Virmani (USA) Pascal Vranckx (Belgium) Don Cutlip (USA) Raymond J. Gibbons (USA) Sidney C. Smith (USA) Dan Atar (Norway) Russell V. Luepker (USA) Rose Marie Robertson (USA) Robert O. Bonow (USA) P. Gabriel Steg (France) Patrick T. O'Gara (USA) Keith A. A. Fox (UK)Document Reviewers David Hasdai (CPG Review Coordinator) (Israel) Victor Aboyans (France) Stephan Achenbach (Germany) Stefan Agewall (Norway) Thomas Alexander (India) Alvaro Avezum (Brazil) Emanuele Barbato (Italy) Jean-Pierre Bassand (France) Eric Bates (USA) John A. Bittl (USA) Güenter Breithardt (Germany) Héctor Bueno (Spain) Raffaele Bugiardini (Italy) Mauricio G. Cohen (USA) George Dangas (USA) James A. de Lemos (USA) Victoria Delgado (the Netherlands) Gerasimos Filippatos (Greece) Edward Fry (USA) Christopher B. Granger (USA) Sigrun Halvorsen (Norway) Mark A. Hlatky (USA) Borja Ibanez (Spain) Stefan James (Sweden) Adnan Kastrati (Germany) Christophe Leclercq (France) Kenneth W. Mahaffey (USA) Laxmi Mehta (USA) Christian Müller (Switzerland) Carlo Patrono (Italy) Massimo Francesco Piepoli (Italy) Daniel Piñeiro (Argentina) Marco Roffi (Switzerland) Andrea Rubboli (Italy) Marc Ruel (Canada) Samin Sharma (USA) Iain A. Simpson (UK) Michael Tendera (Poland) Marco Valgimigli (Switzerland) Allard C. van der Wal (the Netherlands) Stephan Windecker (Switzerland)Table of Contents Abbreviations and acronyms2234 What is new in the Universal Definition of Myocardial Infarction? 2234 Universal definitions of myocardial injury and myocardial infarction: summary2235 Introduction2235 Pathological characteristics of myocardial ischaemia and infarction2236 Biomarker detection of myocardial injury and infarction2236 Clinical presentations of myocardial infarction2238 Clinical classification of myocardial infarction2238 7.1.Myocardial infarction type 12238 7.2.Myocardial infarction type 22239 7.3.Myocardial infarction type 2 and myocardial injury2241 7.4.Myocardial Infarction type 32242 8. References2260 Abbreviations and Acronyms ACS Acute coronary syndrome AHA American Heart Association ARC-2 Academic Research Consortium-2 AUC Area under the curve CAD Coronary artery disease CABG Coronary artery bypass grafting CKD Chronic kidney disease CK-MB Creatine kinase MB isoform CMR Cardiac magnetic resonance CTCA Computed tomographic coronary angiography cTn Cardiac troponin cTnI Cardiac troponin I cTnT Cardiac troponin T CT Computed tomography CV Coefficient of variation EF Ejection fraction ECG Electrocardiogram or electrocardiographic HF Heart failure hs-cTn High-sensitivity cardiac troponin IFCC International Federation of Clinical Chemistry and Laboratory Medicine ISFC International Society and Federation of Cardiology LAD Left anterior descending artery LBBB Left bundle branch block; LoD Limit of detection LGE Late gadolinium enhancement LGE-CMR Late gadolinium enhancement cardiac magnetic resonance LV Left ventricular LVH Left ventricular hypertrophy MI Myocardial infarction MINOCA Myocardial infarction with non-obstructive coronary arteries MONICA MONItoring of trends and determinants in CArdiovascular disease MPS Myocardial perfusion scintigraphy NHLBI National Heart, Lung, and Blood Institute NSTEMI Non-ST-elevation myocardial infarction PET Positron emission tomography PCI Percutaneous coronary intervention POC Point of care RBBB Right bundle branch block SPECT Single photon emission computed tomography STEMI ST-elevation myocardial infarction ST-T ST-segment–T wave TIMI Thrombolysis In Myocardial Infarction TTS Takotsubo syndrome UDMI Universal Definition of Myocardial Infarction URL Upper reference limit WHF World Heart Federation WHO World Health Organization 1 What is New in the Universal Definition of Myocardial Infarction? Silent or unrecognized myocardial infarction.ECG = electrocardiogram; MINOCA = myocardial infarction with non-obstructive coronary arteries; STEMI = ST-elevation myocardial infarction. 2 Universal Definitions of Myocardial Injury and Myocardial Infarction: Summary Universal definitions of myocardial injury and myocardial infarctionCriteria for myocardial injuryThe term myocardial injury should be used when there is evidence of elevated cardiac troponin values (cTn) with at least one value above the 99th percentile upper reference limit (URL).
Abstract
Aims
The incidence of new-onset conduction abnormalities requiring permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) with new-generation prostheses ...remains debated. This systematic review analyses the incidence of PPI after TAVI with new-generation devices and evaluates the electrical, anatomical, and procedural factors associated with PPI. In addition, the incidence of PPI after TAVI with early generation prostheses was reviewed for comparison.
Methods and results
According to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist, this systematic review screened original articles published between October 2010 and October 2017, reporting on the incidence of PPI after implantation of early and new-generation TAVI prostheses. Of the 1406 original articles identified in the first search for new-generation TAVI devices, 348 articles were examined for full text, and finally, 40 studies (n = 17 139) were included. The incidence of a PPI after the use of a new-generation TAVI prosthesis ranged between 2.3% and 36.1%. For balloon-expandable prostheses, the PPI rate remained low when using an early generation SAPIEN device (ranging between 2.3% and 28.2%), and with the new-generation SAPIEN 3 device, the PPI rate was between 4.0% and 24.0%. For self-expandable prostheses, the PPI rates were higher with the early generation CoreValve device (16.3–37.7%), and despite a reduction in PPI rates with the new Evolut R, the rates remained relatively higher (14.7–26.7%). When dividing the studies according to the highest (>26.0%) and the lowest (<12.1%) quintile of PPI rate, patients within the highest quintile were more frequently women when compared with the lowest quintile group (50.9% vs. 46.3%, P < 0.001). Pre-existent conduction abnormalities (electrical factor), calcification of the left ventricular outflow tract (anatomical factor), and balloon valvuloplasty and depth of implantation (procedural factors) were associated with increased risk of PPI.
Conclusion
The rate of PPI after TAVI with new-generation devices is highly variable. Specific recommendations for implantation of each prosthesis, taking into consideration the presence of pre-existent conduction abnormalities and anatomical factors, may be needed to reduce the risk of PPI.
In daily clinical practice, LV systolic function is routinely assessed with the use of two‐dimensional echocardiography. Using biplane LV end‐diastolic and end‐systolic volumes, LVEF is calculated. ...The introduction of real‐time three‐dimensional echocardiography has improved the accuracy of echocardiographic assessment of LVEF. However, calculated LVEF may not truly represent LV systolic function in specific cardiac diseases or when subtle LV dysfunction is present. Two‐dimensional speckle tracking echocardiography enables assessment of myocardial strain, thereby providing detailed information on global and regional LV deformation. This is of particular interest when subtle LV systolic dysfunction is present despite preserved LVEF. In this review, the potential use of LV global longitudinal strain to detect subtle LV systolic dysfunction is illustrated in various clinical scenarios.
Abstract
Aims
The Valve Academic Research Consortium (VARC), founded in 2010, was intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for ...transcatheter and surgical aortic valve clinical trials. Rapid evolution of the field, including the emergence of new complications, expanding clinical indications, and novel therapy strategies have mandated further refinement and expansion of these definitions to ensure clinical relevance. This document provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.
Methods and results
Several years after the publication of the VARC-2 manuscript, an in-person meeting was held involving over 50 independent clinical experts representing several professional societies, academic research organizations, the US Food and Drug Administration (FDA), and industry representatives to (i) evaluate utilization of VARC endpoint definitions in clinical research, (ii) discuss the scope of this focused update, and (iii) review and revise specific clinical endpoint definitions. A writing committee of independent experts was convened and subsequently met to further address outstanding issues. There were ongoing discussions with FDA and many experts to develop a new classification schema for bioprosthetic valve dysfunction and failure. Overall, this multi-disciplinary process has resulted in important recommendations for data reporting, clinical research methods, and updated endpoint definitions. New definitions or modifications of existing definitions are being proposed for repeat hospitalizations, access site-related complications, bleeding events, conduction disturbances, cardiac structural complications, and bioprosthetic valve dysfunction and failure (including valve leaflet thickening and thrombosis). A more granular 5-class grading scheme for paravalvular regurgitation (PVR) is being proposed to help refine the assessment of PVR. Finally, more specific recommendations on quality-of-life assessments have been included, which have been targeted to specific clinical study designs.
Conclusions
Acknowledging the dynamic and evolving nature of less-invasive aortic valve therapies, further refinements of clinical research processes are required. The adoption of these updated and newly proposed VARC-3 endpoints and definitions will ensure homogenous event reporting, accurate adjudication, and appropriate comparisons of clinical research studies involving devices and new therapeutic strategies.
Graphical Abstract
Abstract
Aims
Non-invasive assessment of stable chest pain patients is a critical determinant of resource utilization and clinical outcomes. Increasingly coronary computed tomography angiography ...(CCTA) with selective CCTA-derived fractional flow reserve (FFRCT) is being used. The ADVANCE Registry, is a large prospective examination of using a CCTA and FFRCT diagnostic pathway in real-world settings, with the aim of determining the impact of this pathway on decision-making, downstream invasive coronary angiography (ICA), revascularization, and major adverse cardiovascular events (MACE).
Methods and results
A total of 5083 patients with symptoms concerning for coronary artery disease (CAD) and atherosclerosis on CCTA were enrolled at 38 international sites from 15 July 2015 to 20 October 2017. Demographics, symptom status, CCTA and FFRCT findings, treatment plans, and 90 days outcomes were recorded. The primary endpoint of reclassification between core lab CCTA alone and CCTA plus FFRCT-based management plans occurred in 66.9% confidence interval (CI): 64.8–67.6 of patients. Non-obstructive coronary disease was significantly lower in ICA patients with FFRCT ≤0.80 (14.4%) compared to patients with FFRCT >0.80 (43.8%, odds ratio 0.19, CI: 0.15–0.25, P < 0.001). In total, 72.3% of subjects undergoing ICA with FFRCT ≤0.80 were revascularized. No death/myocardial infarction (MI) occurred within 90 days in patients with FFRCT >0.80 (n = 1529), whereas 19 (0.6%) MACE hazard ratio (HR) 19.75, CI: 1.19–326, P = 0.0008 and 14 (0.3%) death/MI (HR 14.68, CI 0.88–246, P = 0.039) occurred in subjects with an FFRCT ≤0.80.
Conclusions
In a large international multicentre population, FFRCT modified treatment recommendation in two-thirds of subjects as compared to CCTA alone, was associated with less negative ICA, predicted revascularization, and identified subjects at low risk of adverse events through 90 days.
Abstract
Aims
To determine the ranges of pre-test probability (PTP) of coronary artery disease (CAD) in which stress electrocardiogram (ECG), stress echocardiography, coronary computed tomography ...angiography (CCTA), single-photon emission computed tomography (SPECT), positron emission tomography (PET), and cardiac magnetic resonance (CMR) can reclassify patients into a post-test probability that defines (>85%) or excludes (<15%) anatomically (defined by visual evaluation of invasive coronary angiography ICA) and functionally (defined by a fractional flow reserve FFR ≤0.8) significant CAD.
Methods and results
A broad search in electronic databases until August 2017 was performed. Studies on the aforementioned techniques in >100 patients with stable CAD that utilized either ICA or ICA with FFR measurement as reference, were included. Study-level data was pooled using a hierarchical bivariate random-effects model and likelihood ratios were obtained for each technique. The PTP ranges for each technique to rule-in or rule-out significant CAD were defined. A total of 28 664 patients from 132 studies that used ICA as reference and 4131 from 23 studies using FFR, were analysed. Stress ECG can rule-in and rule-out anatomically significant CAD only when PTP is ≥80% (76–83) and ≤19% (15–25), respectively. Coronary computed tomography angiography is able to rule-in anatomic CAD at a PTP ≥58% (45–70) and rule-out at a PTP ≤80% (65–94). The corresponding PTP values for functionally significant CAD were ≥75% (67–83) and ≤57% (40–72) for CCTA, and ≥71% (59–81) and ≤27 (24–31) for ICA, demonstrating poorer performance of anatomic imaging against FFR. In contrast, functional imaging techniques (PET, stress CMR, and SPECT) are able to rule-in functionally significant CAD when PTP is ≥46–59% and rule-out when PTP is ≤34–57%.
Conclusion
The various diagnostic modalities have different optimal performance ranges for the detection of anatomically and functionally significant CAD. Stress ECG appears to have very limited diagnostic power. The selection of a diagnostic technique for any given patient to rule-in or rule-out CAD should be based on the optimal PTP range for each test and on the assumed reference standard.
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