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      Comparison of Early Clinical Outcomes Following Transcatheter Aortic Valve Implantation versus Surgical Aortic Valve Replacement versus Optimal Medical Therapy in Patients Older than 80 Years with Symptomatic Severe Aortic Stenosis

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          Abstract

          Purpose

          Transcatheter aortic valve implantation (TAVI) has become an attractive therapeutic strategy for severe aortic stenosis (AS) in elderly patients due to its minimally-invasive nature. Therefore, early results of its clinical outcomes in elderly Korean patients were evaluated.

          Materials and Methods

          We compared early clinical outcomes of TAVI, surgical aortic valve replacement (SAVR), and optimal medical therapy (OMT) in patients aged ≥80 years with symptomatic severe AS. Treatment groups were allocated as follows: TAVI (n=10), SAVR (n=14), and OMT (n=42).

          Results

          Baseline clinical characteristics including predicted operative mortality were similar among the three groups. However, patients with New York Heart Association functional class III or IV symptoms and smaller aortic valve area were treated with TAVI or SAVR rather than OMT. In-hospital combined safety endpoints (all-cause mortality, major stroke, peri-procedural myocardial infarction, life-threatening bleeding, major vascular complication, and acute kidney injury) after TAVI or SAVR were significantly lower in the TAVI group than in the SAVR group (10.0% vs. 71.4%, respectively, p=0.005), along with an acceptable rate of symptom improvement and device success. During the follow-up period, the TAVI group showed the lowest rate of 3-month major adverse cardiovascular and cerebrovascular events, a composite of all-cause mortality, myocardial infarction, major stroke, and re-hospitalization (TAVI 0.0% vs. SAVR 50.0% vs. OMT 42.9%, p=0.017).

          Conclusion

          Treatment with TAVI was associated with lower event rates compared to SAVR or OMT. Therefore, TAVI may be considered as the first therapeutic strategy in selected patients aged ≥80 years with symptomatic severe AS.

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          Most cited references30

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          Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery?

          To analyse decision-making in elderly patients with severe, symptomatic aortic stenosis (AS). In the Euro Heart Survey on valvular heart disease, 216 patients aged > or =75 had severe AS (valve area or =50 mmHg) and angina or New York Heart Association class III or IV. Patient characteristics were analysed according to the decision to operate or not. A decision not to operate was taken in 72 patients (33%). In multivariable analysis, left ventricular (LV) ejection fraction [OR = 2.27, 95% CI (1.32-3.97) for ejection fraction 30-50, OR = 5.15, 95% CI (1.73-15.35) for ejection fraction 50%, P = 0.003] and age [OR = 1.84, 95% CI (1.18-2.89) for 80-85 years, OR=3.38, 95% CI (1.38-8.27) for > or =85 vs. 75-80 years, P = 0.008] were significantly associated with the decision not to operate; however, the Charlson comorbidity index was not [OR = 1.72, 95% CI (0.83-3.50), P = 0.14 for index > or =2 vs. <2]. Neurological dysfunction was the only comorbidity significantly linked with the decision not to operate. Surgery was denied in 33% of elderly patients with severe, symptomatic AS. Older age and LV dysfunction were the most striking characteristics of patients who were denied surgery, whereas comorbidity played a less important role.
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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.

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

              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
                Yonsei Med J
                Yonsei Med. J
                YMJ
                Yonsei Medical Journal
                Yonsei University College of Medicine
                0513-5796
                1976-2437
                01 May 2013
                19 March 2013
                : 54
                : 3
                : 596-602
                Affiliations
                [1 ]Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea.
                [2 ]Severance Biomedical Science Institute, Yonsei University College of Medicine, Seoul, Korea.
                [3 ]Division of Anesthesiology and Pain Medicine, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea.
                [4 ]Division of Cardiovascular Surgery, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea.
                Author notes
                Corresponding author: Dr. Myeong-Ki Hong, Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul 120-752, Korea. Tel: 82-2-2228-8460, Fax: 82-2-2227-7943, mkhong61@ 123456yuhs.ac
                Article
                10.3349/ymj.2013.54.3.596
                3635628
                23549802
                7f688544-72c7-450e-ba74-1073399b75fb
                © Copyright: Yonsei University College of Medicine 2013

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 25 April 2012
                : 27 June 2012
                : 12 July 2012
                Categories
                Original Article
                Cardiac & Cardiovascular Systems

                Medicine
                aortic stenosis,transcatheter aortic valve implantation,treatment outcome
                Medicine
                aortic stenosis, transcatheter aortic valve implantation, treatment outcome

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