{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2023,10,19]],"date-time":"2023-10-19T07:40:15Z","timestamp":1697701215708},"reference-count":17,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2008,2,20]],"date-time":"2008-02-20T00:00:00Z","timestamp":1203465600000},"content-version":"vor","delay-in-days":5,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2008,2,15]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>To decrease the morbidity associated with conventional surgery for calcific aortic stenosis, there has been increasing interest in catheter\u2010based treatment using a stent or frame mounted bioprosthetic valve. Critical to its success is knowledge of pathoanatomy, risk of embolization of calcific debris, and issues associated with device anchoring and paravalvular leaks. In the absence of a chronic animal model of aortic stenosis, development of a catheter\u2010based device has been an iterative process based on experimental and early clinical data gathered abroad, where marketing may be permitted with less clinical data than required in the United States. This process has persuaded many companies to circumvent the time delays occasioned by the FDA regulatory validation of iterative design changes by performing initial studies outside the United States. Because percutaneous aortic valve replacement is considered a Class III device, premarket approval, including defining the patient population, inclusion and exclusion criteria, control population, and interpretable clinical endpoints, is required. In the early clinical experience, percutaneous aortic valve replacement has been directed at high\u2010risk patients who were considered \u201cvery poor\u201d or \u201cnon\u2010surgical\u201d candidates. Defining and identifying patients for the clinical trial may be challenging, in part because of the difficult selection of an appropriate control group, e.g., conventional aortic valve replacement, best medical management, and\/or balloon valvuloplasty. \u00a9 2008 Wiley\u2010Liss, Inc.<\/jats:p>","DOI":"10.1002\/ccd.21381","type":"journal-article","created":{"date-parts":[[2008,2,21]],"date-time":"2008-02-21T07:19:17Z","timestamp":1203578357000},"page":"434-440","source":"Crossref","is-referenced-by-count":12,"title":["Evolving strategies for the treatment of valvular heart disease: Preclinical and clinical pathways for percutaneous aortic valve replacement"],"prefix":"10.1002","volume":"71","author":[{"given":"James I.","family":"Fann","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicolas","family":"Chronos","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stanton J.","family":"Rowe","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rob","family":"Michiels","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bernard E.","family":"Lyons","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martin B.","family":"Leon","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aaron V.","family":"Kaplan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2008,2,20]]},"reference":[{"key":"e_1_2_6_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(86)90716-6"},{"key":"e_1_2_6_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/0735-1097(91)90853-2"},{"key":"e_1_2_6_4_2","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.1810290102"},{"key":"e_1_2_6_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-5223(19)37390-8"},{"key":"e_1_2_6_6_2","doi-asserted-by":"publisher","DOI":"10.1093\/oxfordjournals.eurheartj.a060238"},{"key":"e_1_2_6_7_2","doi-asserted-by":"publisher","DOI":"10.1148\/radiology.183.1.1549662"},{"key":"e_1_2_6_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(00)02844-0"},{"key":"e_1_2_6_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2006.01.049"},{"key":"e_1_2_6_10_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.106.639450"},{"key":"e_1_2_6_11_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1010-7940(99)00134-7"},{"key":"e_1_2_6_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0195-668X(03)00201-X"},{"key":"e_1_2_6_13_2","first-page":"673","article-title":"Surgical correction of aortic valve insufficiency","volume":"35","author":"Hufnagel CA","year":"1954","journal-title":"Surgery"},{"key":"e_1_2_6_14_2","unstructured":"Non\u2010orthotopic model for stentless heart valve evaluation. From the Office of Science and Technology\u2014Annual Report\u2014Fiscal Year1995. US FDA Center for Devices and Radiological Health. Accessed atwww.fda.gov\/cdrh\/ost\/reports\/fy95\/fluid.html."},{"key":"e_1_2_6_15_2","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.0000047200.36165.B8"},{"key":"e_1_2_6_16_2","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.0000134695.65733.64"},{"key":"e_1_2_6_17_2","unstructured":"Premarket approval (PMA). Device Advice. U.S. Food and Drug Administration. Accessed athttp:\/\/www.fda.gov\/cdrh\/devadvice\/pma\/."},{"key":"e_1_2_6_18_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtcvs.2005.02.013"}],"container-title":["Catheterization and Cardiovascular Interventions"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fccd.21381","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ccd.21381","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,18]],"date-time":"2023-10-18T07:39:14Z","timestamp":1697614754000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/ccd.21381"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2008,2,15]]},"references-count":17,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2008,2,15]]}},"alternative-id":["10.1002\/ccd.21381"],"URL":"https:\/\/doi.org\/10.1002\/ccd.21381","archive":["Portico"],"relation":{},"ISSN":["1522-1946","1522-726X"],"issn-type":[{"value":"1522-1946","type":"print"},{"value":"1522-726X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2008,2,15]]}}}