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      The impact of preoperative frailty status on outcomes after transcatheter aortic valve replacement : An update of systematic review and meta-analysis

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          Abstract

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          Abstract

          Background:

          Frailty is a syndrome of impaired physiologic reserve and decreased resistance to stressors and can often be seen in high-risk patients undergoing transcatheter aortic valve replacement (TAVR). Preoperative frailty status is thought to be related to adverse outcomes after TAVR. We conducted this systematic review and meta-analysis to determine the impact of preoperative frailty status on outcomes among patients after TAVR.

          Methods:

          PubMed, Embase, and the Cochrane Library were searched for relevant studies through January 2018. Fourteen articles (n = 7489) meeting the inclusion criteria were finally included. Possible effects were calculated using meta-analysis.

          Results:

          The pooled risk ratios (RRs) of late mortality (>6 months) and acute kidney injury after TAVR in frail group were 2.81 (95% confidence interval (CI) 1.90–4.15, P < .001, I 2 = 84%) and 1.41 (95% CI 1.02–1.94, P = .04, I 2 = 24%), respectively. Compared with non-frail group, significantly higher incidence of 30-day mortality (RR 2.03, 95% CI 1.63–2.54, P < .001, I 2 = 0%) and life threatening or major bleeding after TAVR (RR 1.48, 95% CI 1.20–1.82, P < .001, I 2 = 14%) was found in frail group. There was no significant association between frailty and incidence of stroke after TAVR (RR 0.93, 95% CI 0.53–1.63, P = .80, I 2 = 0%).

          Conclusion:

          Preoperative frailty status is proved to be significantly associated with poor outcomes after TAVR. Our findings may remind doctors in the field of a more comprehensive preoperative evaluation for TAVR candidates. More well-designed and large-sample sized prospective studies are further needed to figure out the best frailty assessment tool for patients undergoing TAVR.

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          Most cited references34

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          Standardized endpoint definitions for Transcatheter Aortic Valve Implantation clinical trials: a consensus report from the Valve Academic Research Consortium.

          Marie-Pierre Morel, Stephan Windecker, Jeffrey J. Popma … (2011)
          To propose standardized consensus definitions for important clinical endpoints in transcatheter aortic valve implantation (TAVI), investigations in an effort to improve the quality of clinical research and to enable meaningful comparisons between clinical trials. To make these consensus definitions accessible to all stakeholders in TAVI clinical research through a peer reviewed publication, on behalf of the public health. Transcatheter aortic valve implantation may provide a worthwhile less invasive treatment in many patients with severe aortic stenosis and since its introduction to the medical community in 2002, there has been an explosive growth in procedures. The integration of TAVI into daily clinical practice should be guided by academic activities, which requires a harmonized and structured process for data collection, interpretation, and reporting during well-conducted clinical trials. The Valve Academic Research Consortium established an independent collaboration between Academic Research organizations and specialty societies (cardiology and cardiac surgery) in the USA and Europe. Two meetings, in San Francisco, California (September 2009) and in Amsterdam, the Netherlands (December 2009), including key physician experts, and representatives from the U.S. Food and Drug Administration (FDA) and device manufacturers, were focused on creating consistent endpoint definitions and consensus recommendations for implementation in TAVI clinical research programs. Important considerations in developing endpoint definitions included: 1) respect for the historical legacy of surgical valve guidelines; 2) identification of pathophysiological mechanisms associated with clinical events; 3) emphasis on clinical relevance. Consensus criteria were developed for the following endpoints: mortality, myocardial infarction, stroke, bleeding, acute kidney injury, vascular complications, and prosthetic valve performance. Composite endpoints for TAVI safety and effectiveness were also recommended. Although consensus criteria will invariably include certain arbitrary features, an organized multidisciplinary process to develop specific definitions for TAVI clinical research should provide consistency across studies that can facilitate the evaluation of this new important catheter-based therapy. The broadly based consensus endpoint definitions described in this document may be useful for regulatory and clinical trial purposes. Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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            The impact of frailty status on survival after transcatheter aortic valve replacement in older adults with severe aortic stenosis: a single-center experience.

            Philip Green, Abigail E Woglom, Philippe Genereux … (2012)
            This study sought to evaluate the impact of frailty in older adults undergoing transcatheter aortic valve replacement (TAVR) for symptomatic aortic stenosis. Frailty status impacts prognosis in older adults with heart disease; however, the impact of frailty on prognosis after TAVR is unknown. Gait speed, grip strength, serum albumin, and activities of daily living status were collected at baseline and used to derive a frailty score among patients who underwent TAVR procedures at a single large-volume institution. The cohort was dichotomized on the basis of median frailty score into frail and not frail groups. The impact of frailty on procedural outcomes (stroke, bleeding, vascular complications, acute kidney injury, and mortality at 30 days) and 1-year mortality was evaluated. Frailty status was assessed in 159 subjects who underwent TAVR (age 86 ± 8 years, Society of Thoracic Surgery Risk Score 12 ± 4). Baseline frailty score was not associated with conventionally ascertained clinical variables or Society of Thoracic Surgery score. Although high frailty score was associated with a longer post-TAVR hospital stay when compared with lower frailty score (9 ± 6 days vs. 6 ± 5 days, respectively, p = 0.004), there were no significant crude associations between frailty status and procedural outcomes, suggesting adequacy of the standard selection process for identifying patients at risk for periprocedural complications after TAVR. Frailty status was independently associated with increased 1-year mortality (hazard ratio: 3.5, 95% confidence interval: 1.4 to 8.5, p = 0.007) after TAVR. Frailty was not associated with increased periprocedural complications in patients selected as candidates to undergo TAVR but was associated with increased 1-year mortality after TAVR. Further studies will evaluate the independent value of this frailty composite in older adults with aortic stenosis. Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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              2017 ACC Expert Consensus Decision Pathway for Transcatheter Aortic Valve Replacement in the Management of Adults With Aortic Stenosis: A Report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents.

              Catherine M. Otto, Dharam J. Kumbhani, Karen P. Alexander … (2017)
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                Author and article information

                Journal
                Journal ID (nlm-ta): Medicine (Baltimore)
                Journal ID (iso-abbrev): Medicine (Baltimore)
                Journal ID (publisher-id): MEDI
                Title: Medicine
                Publisher: Wolters Kluwer Health
                ISSN (Print): 0025-7974
                ISSN (Electronic): 1536-5964
                Publication date Collection: December 2018
                Publication date (Electronic): 21 December 2018
                Volume: 97
                Issue: 51
                Electronic Location Identifier: e13475
                Affiliations
                [a ]Department of Anesthesiology, West China Hospital
                [b ]Department of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University, Chengdu, Sichuan, China.
                Author notes
                [∗ ]Correspondence: XiaoYun Yang, Department of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University, Chengdu 610041, China (e-mail: cdyangxiaoyun@ 123456163.com ); Hai Yu, Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu 610041, China (e-mail: yuhaishan117@ 123456yahoo.com ).
                Article
                Publisher ID: MD-D-18-02541 Accession ID: 13475
                DOI: 10.1097/MD.0000000000013475
                PMC ID: 6320183
                PubMed ID: 30572446
                SO-VID: 00922a07-4df0-47cf-8f4e-86bc1ce95c93
                Copyright © Copyright © 2018 the Author(s). Published by Wolters Kluwer Health, Inc.
                License:

                This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial License 4.0 (CCBY-NC), where it is permissible to download, share, remix, transform, and buildup the work provided it is properly cited. The work cannot be used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc/4.0

                History
                Date received : 8 April 2018
                Date accepted : 7 November 2018
                Categories
                Subject: 3400
                Subject: Research Article
                Subject: Systematic Review and Meta-Analysis
                Custom metadata
                OPEN-ACCESS TRUE

                Keywords: aortic stenosis,complication,frailty,mortality,risk factor,tavr
                Data availability:
                Keywords: aortic stenosis, complication, frailty, mortality, risk factor, tavr

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