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      TAVR and SAVR: Current Treatment of Aortic Stenosis

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          Abstract

          Transcatheter aortic valve replacement (TAVR) was approved in the United States in late 2011, providing a critically needed alternative therapy for patients with severe aortic stenosis previously refused surgical aortic valve replacement (SAVR). Over 20,000 TAVR have been performed in patients worldwide since 2002 when Alain Cribier performed the first-in-man TAVR. This paper reviews the data from balloon expandable and self-expanding aortic stent valves as well as data comparing them with traditional surgical aortic valve replacement (SAVR). Complications using criteria established by the Valve Academic Research Consortium (VARC) are reviewed. Future challenges and possibilities are discussed and will make optimizing TAVR an important goal in the years to come.

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          Two-year outcomes after transcatheter or surgical aortic-valve replacement.

          Susheel Kodali, Mathew R Williams, Craig R Smith … (2012)
          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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            2008 focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to revise the 1998 guidelines for the management of patients with valvular heart disease). Endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons.

            Robert Bonow, Blase Carabello, Kanu Chatterjee … (2008)
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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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                Author and article information

                Journal
                Journal ID (nlm-ta): Clin Med Insights Cardiol
                Journal ID (iso-abbrev): Clin Med Insights Cardiol
                Journal ID (publisher-id): 101466475
                Title: Clinical Medicine Insights. Cardiology
                Publisher: Libertas Academica
                ISSN (Electronic): 1179-5468
                Publication date Collection: 2012
                Publication date (Electronic): 23 August 2012
                Volume: 6
                Pages: 125-139
                Affiliations
                International Cardiovascular Institute, 8275 S. Eastern Ave. Suite 200-385, Las Vegas, NV 89123, USA.
                Author notes
                Corresponding author email: dr.hu.md@ 123456gmail.com
                Article
                Publisher ID: cmc-6-2012-125
                DOI: 10.4137/CMC.S7540
                PMC ID: 3431975
                PubMed ID: 22952419
                SO-VID: 8a120971-69db-41ab-a779-90b5ba90e2f6
                Copyright © © the author(s), publisher and licensee Libertas Academica Ltd.
                License:

                This is an open access article. Unrestricted non-commercial use is permitted provided the original work is properly cited.

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                Subject: Review

                ScienceOpen disciplines: Cardiovascular Medicine
                Keywords: savr,tavr,partner,corevalve,complications,aortic stenosis,acurate,transcatheter,sapien,jenavalve,review,valve academic research consortium,stent valve,transcatheter aortic valve replacement,varc,tavi
                Data availability:
                ScienceOpen disciplines: Cardiovascular Medicine
                Keywords: savr, tavr, partner, corevalve, complications, aortic stenosis, acurate, transcatheter, sapien, jenavalve, review, valve academic research consortium, stent valve, transcatheter aortic valve replacement, varc, tavi

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