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      Post‐Procedural Troponin Elevation and Clinical Outcomes Following Transcatheter Aortic Valve Implantation

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          Abstract

          Background

          Biomarkers of myocardial injury increase frequently during transcatheter aortic valve implantation ( TAVI). The impact of postprocedural cardiac troponin ( cTn) elevation on short‐term outcomes remains controversial, and the association with long‐term prognosis is unknown.

          Methods and Results

          We evaluated 577 consecutive patients with severe aortic stenosis treated with TAVI between 2007 and 2012. Myocardial injury, defined according to the Valve Academic Research Consortium ( VARC)‐2 as post‐ TAVI cardiac troponin T (cTnT) >15× the upper limit of normal, occurred in 338 patients (58.1%). In multivariate analyses, myocardial injury was associated with higher risk of all‐cause mortality at 30 days (adjusted hazard ratio [ HR], 8.77; 95% CI, 2.07–37.12; P=0.003) and remained a significant predictor at 2 years (adjusted HR, 1.98; 95% CI, 1.36–2.88; P<0.001). Higher cTnT cutoffs did not add incremental predictive value compared with the VARC‐2–defined cutoff. Whereas myocardial injury occurred more frequently in patients with versus without coronary artery disease ( CAD), the relative impact of cTnT elevation on 2‐year mortality did not differ between patients without CAD (adjusted HR, 2.59; 95% CI, 1.27–5.26; P=0.009) and those with CAD (adjusted HR, 1.71; 95% CI, 1.10–2.65; P=0.018; P for interaction=0.24). Mortality rates at 2 years were lowest in patients without CAD and no myocardial injury (11.6%) and highest in patients with complex CAD ( SYNTAX score >22) and myocardial injury (41.1%).

          Conclusions

          VARC‐2–defined cTnT elevation emerged as a strong, independent predictor of 30‐day mortality and remained a modest, but significant, predictor throughout 2 years post‐ TAVI. The prognostic value of cTnT elevation was modified by the presence and complexity of underlying CAD with highest mortality risk observed in patients combining SYNTAX score >22 and evidence of myocardial injury.

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          Most cited references25

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          The SYNTAX Score: an angiographic tool grading the complexity of coronary artery disease.

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            Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.

            The aim of the current Valve Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI) clinical endpoints to make them more suitable to the present and future needs of clinical trials. In addition, this document is intended to expand the understanding of patient risk stratification and case selection. A recent study confirmed that VARC definitions have already been incorporated into clinical and research practice and represent a new standard for consistency in reporting clinical outcomes of patients with symptomatic severe aortic stenosis (AS) undergoing TAVI. However, as the clinical experience with this technology has matured and expanded, certain definitions have become unsuitable or ambiguous. Two in-person meetings (held in September 2011 in Washington, DC, USA, and in February 2012 in Rotterdam, the Netherlands) involving VARC study group members, independent experts (including surgeons, interventional and non-interventional cardiologists, imaging specialists, neurologists, geriatric specialists, and clinical trialists), the US Food and Drug Administration (FDA), and industry representatives, provided much of the substantive discussion from which this VARC-2 consensus manuscript was derived. This document provides an overview of risk assessment and patient stratification that need to be considered for accurate patient inclusion in studies. Working groups were assigned to define the following clinical endpoints: mortality, stroke, myocardial infarction, bleeding complications, acute kidney injury, vascular complications, conduction disturbances and arrhythmias, and a miscellaneous category including relevant complications not previously categorized. Furthermore, comprehensive echocardiography recommendations are provided for the evaluation of prosthetic valve (dys)function. Definitions for the quality of life assessments are also reported. These endpoints formed the basis for several recommended composite endpoints. This VARC-2 document has provided further standardization of endpoint definitions for studies evaluating the use of TAVI, which will lead to improved comparability and interpretability of the study results, supplying an increasingly growing body of evidence with respect to TAVI and/or surgical aortic valve replacement. This initiative and document can furthermore be used as a model during current endeavors of applying definitions to other transcatheter valve therapies (for example, mitral valve repair). Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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              Two-year outcomes after transcatheter or surgical aortic-valve replacement.

              The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that among high-risk patients with aortic stenosis, the 1-year survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical replacement. However, longer-term follow-up is necessary to determine whether TAVR has prolonged benefits. At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either surgical aortic-valve replacement or TAVR. All patients were followed for at least 2 years, with assessment of clinical outcomes and echocardiographic evaluation. The rates of death from any cause were similar in the TAVR and surgery groups (hazard ratio with TAVR, 0.90; 95% confidence interval [CI], 0.71 to 1.15; P=0.41) and at 2 years (Kaplan-Meier analysis) were 33.9% in the TAVR group and 35.0% in the surgery group (P=0.78). The frequency of all strokes during follow-up did not differ significantly between the two groups (hazard ratio, 1.22; 95% CI, 0.67 to 2.23; P=0.52). At 30 days, strokes were more frequent with TAVR than with surgical replacement (4.6% vs. 2.4%, P=0.12); subsequently, there were 8 additional strokes in the TAVR group and 12 in the surgery group. Improvement in valve areas was similar with TAVR and surgical replacement and was maintained for 2 years. Paravalvular regurgitation was more frequent after TAVR (P<0.001), and even mild paravalvular regurgitation was associated with increased late mortality (P<0.001). A 2-year follow-up of patients in the PARTNER trial supports TAVR as an alternative to surgery in high-risk patients. The two treatments were similar with respect to mortality, reduction in symptoms, and improved valve hemodynamics, but paravalvular regurgitation was more frequent after TAVR and was associated with increased late mortality. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.).
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                Author and article information

                Journal
                J Am Heart Assoc
                J Am Heart Assoc
                10.1002/(ISSN)2047-9980
                JAH3
                ahaoa
                Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
                John Wiley and Sons Inc. (Hoboken )
                2047-9980
                19 February 2016
                February 2016
                : 5
                : 2 ( doiID: 10.1002/jah3.2016.5.issue-2 )
                : e002430
                Affiliations
                [ 1 ] Department of CardiologyBern University Hospital BernSwitzerland
                [ 2 ] Center for Laboratory Medicine InselspitalUniversity Hospital Bern BernSwitzerland
                [ 3 ] Institute of Primary Health CareUniversity of Bern Switzerland
                [ 4 ] Institute of Social and Preventive MedicineUniversity of Bern Switzerland
                Author notes
                [*] [* ] Correspondence to: Stephan Windecker, MD, Department of Cardiology, Bern University Hospital, Freiburgstrasse 10, 3010 Bern, Switzerland. E‐mail: stephan.windecker@ 123456insel.ch
                Article
                JAH31341
                10.1161/JAHA.115.002430
                4802442
                26896474
                dbd8e579-e8a4-461e-a787-f2f25394dffa
                © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

                This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

                History
                : 21 October 2015
                : 30 December 2015
                Page count
                Pages: 11
                Categories
                Original Research
                Original Research
                Valvular Heart Disease
                Custom metadata
                2.0
                jah31341
                February 2016
                Converter:WILEY_ML3GV2_TO_NLMPMC version:4.8.4 mode:remove_FC converted:03.03.2016

                Cardiovascular Medicine
                aortic stenosis,prognosis,transcatheter aortic valve implantation,troponin,aortic valve replacement/transcather aortic valve implantation,biomarkers,catheter-based coronary and valvular interventions

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