--- title: "Health status after TAVR: CoreValve US trial. | Sutter Health" description: "Among patients with severe aortic stenosis, TAVR with a self-expanding bioprosthesis resulted in substantial improvements in both disease-specific and generic health-related quality of life, but there remained a large minority of patients who died or had very poor quality of life despite TAVR." url: "https://www.sutterhealth.org/research/publications/health-status-post-tavr-corevalve-us-trial-1055312500" --- 1. [Home](https://www.sutterhealth.org/) / 2. [Research](https://www.sutterhealth.org/research) / 3. [Research publications](https://www.sutterhealth.org/research/publications) / 4. Health status after TAVR: CoreValve US trial. # Health status after transcatheter aortic valve replacement in patients at extreme surgical risk: results from the CoreValve U.S. trial. Osnabrugge RL, Arnold SV, Reynolds MR, Magnuson EA, Wang K, Gaudiani VA, Stoler RC, Burdon TA, Kleiman N, Reardon MJ, Adams DH, Popma JJ, & Cohen DJ; CoreValve U.S. Trial Investigators. _JACC Cardiovasc Interv. 8(2):315-23. doi: 10.1016/j.jcin.2014.08.016._ 2015-02-01 ## Abstract OBJECTIVES: The purpose of this study was to characterize health status outcomes after transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis among patients at extreme surgical risk and to identify pre-procedural patient characteristics associated with a poor outcome. BACKGROUND: For many patients considering TAVR, improvement in quality of life may be of even greater importance than prolonged survival. METHODS: Patients with severe, symptomatic aortic stenosis who were considered to be at prohibitive risk for surgical aortic valve replacement were enrolled in the single-arm CoreValve U.S. Extreme Risk Study. Health status was assessed at baseline and at 1, 6, and 12 months after TAVR using the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Short Form-12, and the EuroQol-5D. The overall summary scale of the KCCQ (range 0 to 100; higher scores = better health) was the primary health status outcome. A poor outcome after TAVR was defined as death, a KCCQ overall summary score (OS) <45, or a decline in KCCQ-OS of 10 points at 6-month follow-up. RESULTS: A total of 471 patients underwent TAVR via the transfemoral approach, of whom 436 (93%) completed the baseline health status survey. All health status measures demonstrated considerable impairment at baseline. After TAVR, there was substantial improvement in both disease-specific and generic health status measures, with an increase in the KCCQ-OS of 23.9 points (95% confidence interval \[CI\]: 20.3 to 27.5 points) at 1 month, 27.4 points (95% CI: 24.2 to 30.6 points) at 6 months, 27.4 points (95% CI: 24.1 to 30.8 points) at 12 months, along with substantial increases in Short Form-12 scores and EuroQol-5D utilities (all p < 0.003 compared with baseline). Nonetheless, 39% of patients had a poor outcome after TAVR. Baseline factors independently associated with poor outcome included wheelchair dependency, lower mean aortic valve gradient, prior coronary artery bypass grafting, oxygen dependency, very high predicted mortality with surgical aortic valve replacement, and low serum albumin. CONCLUSIONS: Among patients with severe aortic stenosis, TAVR with a self-expanding bioprosthesis resulted in substantial improvements in both disease-specific and generic health-related quality of life, but there remained a large minority of patients who died or had very poor quality of life despite TAVR. Predictive models based on a combination of clinical factors as well as disability and frailty may provide insight into the optimal patient population for whom TAVR is beneficial. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902). [PubMed abstract](http://www.ncbi.nlm.nih.gov/pubmed/25700755) ## Research topics - [Cardiovascular Diseases](https://www.sutterhealth.org/research-search-results?query=%22%5C%22Cardiovascular+Diseases%5C%22%22) - [Disease Management](https://www.sutterhealth.org/research-search-results?query=%22%5C%22Disease+Management%5C%22%22) ## Related publications [View all publications](https://www.sutterhealth.org/research-search-results?verticalKey=research_publication) - Publication ### [Non-contrast-enhanced peripheral angiography using a sliding interleaved cylinder acquisition.](https://www.sutterhealth.org/research/publications/noncontrast-enhance-periph-angiog-use-slincyl-1055312471) Kwon KT, Kerr AB, Wu HH, Hu BS, Brittain JH, Nishimura DG. Magn Reson Med. 74(3):727-38. doi: 10.1002/mrm.25452. Epub 2014 Sep 9. 2015 Sep 01 - Publication ### [Off-resonance-robust velocity-selective magnetization preparation for non-contrast-enhanced peripheral MR angiography.](https://www.sutterhealth.org/research/publications/off-reson-robust-veloc-select-magnetiz-prep-mra-1055312480) Shin T, Hu BS, Nishimura DG. Magn Reson Med. 70(5):1229-40. doi: 10.1002/mrm.24561. Epub 2012 Nov 28. 2013 Nov 01 - Publication ### [Nonrigid motion correction with 3D image-based navigators for coronary MR angiography.](https://www.sutterhealth.org/research/publications/motion-correction-3d-image-navig-ht-mra-1055312449) Luo J, Addy NO, Ingle RR, Baron CA, Cheng JY, Hu BS, Nishimura DG. Magn Reson Med. doi: 10.1002/mrm.26273. \[Epub ahead of print\] 2016 May 13 - Publication ### [3D image-based navigators for coronary MR angiography.](https://www.sutterhealth.org/research/publications/3d-image-navig-ht-mr-angiography-1055312459) Addy NO, Ingle RR, Luo J, Baron CA, Yang PC, Hu BS, Nishimura DG. Magn Reson Med. doi: 10.1002/mrm.26269. \[Epub ahead of print\] 2016 May 13 - Publication ### [Antiplatelet therapy use after discharge among acute myocardial infarction patients with in-hospital bleeding.](https://www.sutterhealth.org/research/publications/antiplatelet-tx-post-discharge-ami-pts-1055312976) Wang TY, Xiao L, Alexander KP, Rao SV, Kosiborod MN, Rumsfeld JS, Spertus JA, Peterson ED. Circulation. 118(21):2139-45. doi: 10.1161/CIRCULATIONAHA.108.787143. Epub 2008 Nov 3. 2008 Nov 18 [View all publications](https://www.sutterhealth.org/research-search-results?verticalKey=research_publication) ```json {"@context":"https://schema.org","@type":"MedicalOrganization","name":"Sutter Health","@id":"https://www.sutterhealth.org/#medicalorganization","url":"https://www.sutterhealth.org","logo":"https://www.sutterhealth.org/static/images/sutter-health-logo.svg","address":{"@type":"PostalAddress","streetAddress":"2200 River Plaza Drive","addressLocality":"Sacramento","addressRegion":"CA","postalCode":"95833","addressCountry":"US"},"areaServed":{"@type":"AdministrativeArea","name":"California"},"sameAs":["https://www.facebook.com/SutterHealth","https://www.instagram.com/sutterhealth/","https://x.com/SutterHealth","https://www.youtube.com/sutterhealth","https://www.linkedin.com/company/sutter-health","https://en.wikipedia.org/wiki/Sutter_Health"]} ``` ```json {"@context":"https://schema.org","@type":"BreadcrumbList","@id":"https://www.sutterhealth.org/research/publications/health-status-post-tavr-corevalve-us-trial-1055312500#breadcrumblist","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https://www.sutterhealth.org/"},{"@type":"ListItem","position":2,"name":"Research","item":"https://www.sutterhealth.org/research"},{"@type":"ListItem","position":3,"name":"Research publications","item":"https://www.sutterhealth.org/research/publications"},{"@type":"ListItem","position":4,"name":"Health status after TAVR: CoreValve US trial."}]} ``` ```json {"@context":"https://schema.org","@type":"MedicalScholarlyArticle","@id":"https://www.sutterhealth.org/research/publications/health-status-post-tavr-corevalve-us-trial-1055312500#medicalscholarlyarticle","name":"Health status after transcatheter aortic valve replacement in patients at extreme surgical risk: results from the CoreValve U.S. trial.","headline":"Health status after TAVR: CoreValve US trial.","abstract":"OBJECTIVES: The purpose of this study was to characterize health status outcomes after transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis among patients at extreme surgical risk and to identify pre-procedural patient characteristics associated with a poor outcome. BACKGROUND: For many patients considering TAVR, improvement in quality of life may be of even greater importance than prolonged survival. METHODS: Patients with severe, symptomatic aortic stenosis who were considered to be at prohibitive risk for surgical aortic valve replacement were enrolled in the single-arm CoreValve U.S. Extreme Risk Study. Health status was assessed at baseline and at 1, 6, and 12 months after TAVR using the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Short Form-12, and the EuroQol-5D. The overall summary scale of the KCCQ (range 0 to 100; higher scores = better health) was the primary health status outcome. A poor outcome after TAVR was defined as death, a KCCQ overall summary score (OS) \u003c45, or a decline in KCCQ-OS of 10 points at 6-month follow-up. RESULTS: A total of 471 patients underwent TAVR via the transfemoral approach, of whom 436 (93%) completed the baseline health status survey. All health status measures demonstrated considerable impairment at baseline. After TAVR, there was substantial improvement in both disease-specific and generic health status measures, with an increase in the KCCQ-OS of 23.9 points (95% confidence interval [CI]: 20.3 to 27.5 points) at 1 month, 27.4 points (95% CI: 24.2 to 30.6 points) at 6 months, 27.4 points (95% CI: 24.1 to 30.8 points) at 12 months, along with substantial increases in Short Form-12 scores and EuroQol-5D utilities (all p \u003c 0.003 compared with baseline). Nonetheless, 39% of patients had a poor outcome after TAVR. Baseline factors independently associated with poor outcome included wheelchair dependency, lower mean aortic valve gradient, prior coronary artery bypass grafting, oxygen dependency, very high predicted mortality with surgical aortic valve replacement, and low serum albumin. CONCLUSIONS: Among patients with severe aortic stenosis, TAVR with a self-expanding bioprosthesis resulted in substantial improvements in both disease-specific and generic health-related quality of life, but there remained a large minority of patients who died or had very poor quality of life despite TAVR. Predictive models based on a combination of clinical factors as well as disability and frailty may provide insight into the optimal patient population for whom TAVR is beneficial. 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