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      Comparison of Outcomes After Transcatheter Aortic Valve Replacement vs Surgical Aortic Valve Replacement Among Patients With Aortic Stenosis at Low Operative Risk

      research-article
      , MD 1 , , MD, PhD 1 , , MD 2 , , MD, PhD 3 , , MD 4 , , MD, PhD 5 , , MD 6 , , MD, PhD 6 , , MD 1 , , MD, PhD 4 , , MD, PhD 4 , , MD, PhD 2 , , RN 2 , , MD, PhD 2 , , MD, PhD 2 , , MSc 7 , , MSc 7 , , MD, PhD 2 , , MD, PhD 4 , , MD, PhD 4 , , MD, PhD 5 , , MD, PhD 3 , , MD, PhD 4 , , MD, PhD 2 , 6 , 8 ,
      JAMA Network Open
      American Medical Association

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          Abstract

          This comparative effectiveness cohort study examines 30-day and 3-year survival among Finnish patients with aortic stenosis at low operative risk who underwent transcatheter aortic valve replacement compared with surgical aortic valve replacement.

          Key Points

          Question

          Does transcatheter aortic valve replacement achieve similar results compared with surgical aortic valve replacement in patients at low operative risk with severe aortic stenosis?

          Findings

          In this comparative effectiveness cohort study of 2841 low-risk patients with aortic stenosis from Finalnd, propensity score–matching analysis showed similar 30-day and 3-year survival after transcatheter aortic valve replacement and surgical aortic valve replacement.

          Meaning

          Patients with severe aortic stenosis at low operative risk may be offered transcatheter aortic valve replacement instead of surgical aortic valve replacement.

          Abstract

          Importance

          Transcatheter aortic valve replacement (TAVR) has been shown to be a valid alternative to surgical aortic valve replacement (SAVR) in patients at high operative risk with severe aortic stenosis (AS). However, the evidence of the benefits and harms of TAVR in patients at low operative risk is still scarce.

          Objective

          To compare the short-term and midterm outcomes after TAVR and SAVR in low-risk patients with AS.

          Design, Setting, and Participants

          This retrospective comparative effectiveness cohort study used data from the Nationwide Finnish Registry of Transcatheter and Surgical Aortic Valve Replacement for Aortic Valve Stenosis of patients at low operative risk who underwent TAVR or SAVR with a bioprosthesis for severe AS from January 1, 2008, to November 30, 2017. Low operative risk was defined as a Society of Thoracic Surgeons Predicted Risk of Mortality score less than 3% without other comorbidities of clinical relevance. One-to-one propensity score matching was performed to adjust for baseline covariates between the TAVR and SAVR cohorts.

          Exposures

          Primary TAVR or SAVR with a bioprosthesis for AS with or without associated coronary revascularization.

          Main Outcomes and Measures

          The primary outcomes were 30-day and 3-year survival.

          Results

          Overall, 2841 patients (mean [SD] age, 74.0 [6.2] years; 1560 [54.9%] men) fulfilled the inclusion criteria and were included in the analysis; TAVR was performed in 325 patients and SAVR in 2516 patients. Propensity score matching produced 304 pairs with similar baseline characteristics. Third-generation devices were used in 263 patients (86.5%) who underwent TAVR. Among these matched pairs, 30-day mortality was 1.3% after TAVR and 3.6% after SAVR ( P = .12). Three-year survival was similar in the study cohorts (TAVR, 85.7%; SAVR, 87.7%; P = .45). Interaction tests found no differences in terms of 3-year survival between the study cohorts in patients younger than vs older than 80 years or in patients who received recent aortic valve prostheses vs those who did not.

          Conclusions and Relevance

          Transcatheter aortic valve replacement using mostly third-generation devices achieved similar short- and mid-term survival compared with SAVR in low-risk patients. Further studies are needed to assess the long-term durability of TAVR prostheses before extending their use to low-risk patients.

          Related collections

          Most cited references16

          • Record: found
          • Abstract: found
          • Article: not found

          Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Valve Stenosis

          Transcatheter aortic valve replacement (TAVR) is an option in certain high-risk surgical patients with severe aortic valve stenosis. It is unknown whether TAVR can be safely introduced to lower-risk patients.
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            • Record: found
            • Abstract: not found
            • Article: not found

            Durability of Transcatheter and Surgical Bioprosthetic Aortic Valves in Patients at Lower Surgical Risk

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              • Record: found
              • Abstract: found
              • Article: not found

              Paravalvular leak after transcatheter aortic valve replacement: the new Achilles' heel? A comprehensive review of the literature.

              Paravalvular leak (PVL) is a frequent complication of transcatheter aortic valve replacement (TAVR) and is seen at a much higher rate after TAVR than after conventional surgical aortic valve replacement. Recent reports indicating that PVL may be correlated with increased late mortality have raised concerns. However, the heterogeneity of methods for assessing and quantifying PVL, and lack of consistency in the timing of such assessments, is a hindrance to understanding its true prevalence, severity, and effect. This literature review is an effort to consolidate current knowledge in this area to better understand the prevalence, progression, and impact of post-TAVR PVL and to help direct future efforts regarding the assessment, prevention, and treatment of this troublesome complication. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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                Author and article information

                Journal
                JAMA Netw Open
                JAMA Netw Open
                JAMA Netw Open
                JAMA Network Open
                American Medical Association
                2574-3805
                14 June 2019
                June 2019
                14 June 2019
                : 2
                : 6
                : e195742
                Affiliations
                [1 ]Heart Hospital, Tampere University Hospital, Faculty of Medicine and Health Technology, Tampere, Finland
                [2 ]Heart Center, Turku University Hospital, Turku, Finland
                [3 ]Heart Center, Kuopio University Hospital, Kuopio, Finland
                [4 ]Heart Center, Helsinki University Hospital, Helsinki, Finland
                [5 ]Department of Internal Medicine, Oulu University Hospital, Oulu, Finland
                [6 ]Department of Surgery, Oulu University Hospital, University of Oulu, Oulu, Finland
                [7 ]National Centre of Global Health, Istituto Superiore di Sanità, Rome, Italy
                [8 ]Department of Surgery, University of Turku, Turku, Finland
                Author notes
                Article Information
                Accepted for Publication: April 25, 2019.
                Published: June 14, 2019. doi:10.1001/jamanetworkopen.2019.5742
                Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2019 Virtanen MPO et al. JAMA Network Open.
                Corresponding Author: Fausto Biancari, MD, PhD, Heart Center, Turku University Hospital, PO Box 52, 20521 Turku, Finland ( faustobiancari@ 123456yahoo.it ).
                Author Contributions: Dr Biancari had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
                Concept and design: Virtanen, Eskola, Husso, Niemelä, Ahvenvaara, Kinnunen, Vasankari, Airaksinen, Anttila, Juvonen, Laine, Mäkikallio, Valtola, Raivio, Biancari.
                Acquisition, analysis, or interpretation of data: Virtanen, Jalava, Laakso, Niemelä, Tauriainen, Maaranen, Kinnunen, Dahlbacka, Jaakkola, Airaksinen, Rosato, D’Errigo, Savontaus, Mäkikallio, Valtola, Raivio, Biancari.
                Drafting of the manuscript: Virtanen, Jalava, Husso, Ahvenvaara, Anttila, Rosato, Juvonen, Mäkikallio, Biancari.
                Critical revision of the manuscript for important intellectual content: Virtanen, Eskola, Jalava, Laakso, Niemelä, Ahvenvaara, Tauriainen, Maaranen, Kinnunen, Dahlbacka, Jaakkola, Vasankari, Airaksinen, Anttila, D’Errigo, Savontaus, Laine, Mäkikallio, Valtola, Raivio, Biancari.
                Statistical analysis: Virtanen, Rosato, D’Errigo, Mäkikallio, Biancari.
                Administrative, technical, or material support: Jalava, Husso, Vasankari, Airaksinen, Anttila, Savontaus, Juvonen, Laine, Valtola, Raivio.
                Supervision: Eskola, Airaksinen, Anttila, Valtola, Raivio, Biancari.
                Conflict of Interest Disclosures: Dr Airaksinen reported receiving grants from Finnish Foundation for Cardiovascular Research outside the submitted work. Dr Savontaus reported receiving personal fees from Medtronic and Boston Scientific during the conduct of the study. Dr Juvonen reported receiving grants from the Finnish Foundation for Cardiovascular research outside the submitted work. Dr Laine reported receiving personal fees from Boston Scientific during the conduct of the study. No other disclosures were reported.
                Article
                zoi190233
                10.1001/jamanetworkopen.2019.5742
                6575142
                31199448
                8f422779-27d4-491f-9014-67d160144f92
                Copyright 2019 Virtanen MPO et al. JAMA Network Open.

                This is an open access article distributed under the terms of the CC-BY License.

                History
                : 27 January 2019
                : 25 April 2019
                Categories
                Research
                Original Investigation
                Online Only
                Cardiology

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