Midterm Stability and Hemodynamic Performance of a Transfemorally Implantable Nonmetallic, Retrievable, and Repositionable Aortic Valve in Patients With Severe Aortic Stenosis: Up to 2-Year Follow-Up of the Direct-Flow Medical Valve: A Pilot Study
BACKGROUND—Misplacement during percutaneous aortic valve implantation can be associated with severe complications. The direct flow medical (DFM) valve is repositionable and retrievable; however, the nonmetallic inflatable and conformable design of the valve results in less radial force, which may ha...
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| Veröffentlicht in: | Circulation. Cardiovascular interventions 2011-12, Vol.4 (6), p.595-601 |
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| creator | Bijuklic, Klaudija Tuebler, Thilo Reichenspurner, Hermann Treede, Hendrik Wandler, Andreas Harreld, John H Low, Reginald I Schofer, Joachim |
| description | BACKGROUND—Misplacement during percutaneous aortic valve implantation can be associated with severe complications. The direct flow medical (DFM) valve is repositionable and retrievable; however, the nonmetallic inflatable and conformable design of the valve results in less radial force, which may have an impact on stability and valve function over time. We, therefore, analyzed the midterm stability of the position, shape, and hemodynamic performance of the DFM percutaneous aortic valve.
METHODS AND RESULTS—Sixteen symptomatic high-risk for surgery patients with aortic stenosis and a logistic EuroSCORE >20 underwent implantation and were the subject of this analysis. Clinical, echocardiographic, and dual-source multislice computed tomography data were obtained during 2-year follow-up. The 1- and 2-year survival rates were 81% and 69%, respectively. The dual-source multislice computed tomography follow-up indicated no changes in position, diameter, and orifice area of the DFM valve over time. Echocardiography revealed a significant decrease of the mean gradient from baseline (50.1±11.3 mm Hg) to 30 days (19.6±5.7 mm Hg, P |
| doi_str_mv | 10.1161/CIRCINTERVENTIONS.111.964072 |
| format | Article |
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METHODS AND RESULTS—Sixteen symptomatic high-risk for surgery patients with aortic stenosis and a logistic EuroSCORE >20 underwent implantation and were the subject of this analysis. Clinical, echocardiographic, and dual-source multislice computed tomography data were obtained during 2-year follow-up. The 1- and 2-year survival rates were 81% and 69%, respectively. The dual-source multislice computed tomography follow-up indicated no changes in position, diameter, and orifice area of the DFM valve over time. Echocardiography revealed a significant decrease of the mean gradient from baseline (50.1±11.3 mm Hg) to 30 days (19.6±5.7 mm Hg, P<0.001), which remained stable over 2 years. The aortic valve area increased from 0.57±0.15 cm at baseline to 1.47±0.35 cm at 30 days (P<0.001) and did not significantly change during 2-year follow-up. Of the patients, 73% had no aortic regurgitation (AR) and 27% had minimal AR.
CONCLUSIONS—In this preliminary series, the 2-year follow-up data of patients, in whom the nonmetallic, repositionable, and retrievable DFM valve was successfully implanted, show stability of the position, shape, and hemodynamic performance, with no AR in most patients.</description><identifier>ISSN: 1941-7640</identifier><identifier>EISSN: 1941-7632</identifier><identifier>DOI: 10.1161/CIRCINTERVENTIONS.111.964072</identifier><identifier>PMID: 22128202</identifier><language>eng</language><publisher>Hagerstown, MD: American Heart Association, Inc</publisher><subject>Aged ; Aged, 80 and over ; Angioplasty - methods ; Aortic Valve - diagnostic imaging ; Aortic Valve - physiology ; Aortic Valve Stenosis - mortality ; Aortic Valve Stenosis - physiopathology ; Aortic Valve Stenosis - therapy ; Biological and medical sciences ; Blood and lymphatic vessels ; Cardiology. Vascular system ; Cardiovascular system ; Diseases of the aorta ; Echocardiography ; Female ; Femoral Vein ; Follow-Up Studies ; Heart Valve Prosthesis ; Heart Valve Prosthesis Implantation - methods ; Hemodynamics - physiology ; Humans ; Investigative techniques, diagnostic techniques (general aspects) ; Kaplan-Meier Estimate ; Male ; Medical sciences ; Multidetector Computed Tomography ; Orthopedic surgery ; Pilot Projects ; Regional Blood Flow - physiology ; Severity of Illness Index ; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases ; Treatment Outcome ; Ultrasonic investigative techniques</subject><ispartof>Circulation. Cardiovascular interventions, 2011-12, Vol.4 (6), p.595-601</ispartof><rights>2011 American Heart Association, Inc.</rights><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c2539-ab93da472b93cd797b93829327a65d31b4e070c7dc6cb80cfe722e7d2d4690093</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,3674,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=25395944$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22128202$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bijuklic, Klaudija</creatorcontrib><creatorcontrib>Tuebler, Thilo</creatorcontrib><creatorcontrib>Reichenspurner, Hermann</creatorcontrib><creatorcontrib>Treede, Hendrik</creatorcontrib><creatorcontrib>Wandler, Andreas</creatorcontrib><creatorcontrib>Harreld, John H</creatorcontrib><creatorcontrib>Low, Reginald I</creatorcontrib><creatorcontrib>Schofer, Joachim</creatorcontrib><title>Midterm Stability and Hemodynamic Performance of a Transfemorally Implantable Nonmetallic, Retrievable, and Repositionable Aortic Valve in Patients With Severe Aortic Stenosis: Up to 2-Year Follow-Up of the Direct-Flow Medical Valve: A Pilot Study</title><title>Circulation. Cardiovascular interventions</title><addtitle>Circ Cardiovasc Interv</addtitle><description>BACKGROUND—Misplacement during percutaneous aortic valve implantation can be associated with severe complications. The direct flow medical (DFM) valve is repositionable and retrievable; however, the nonmetallic inflatable and conformable design of the valve results in less radial force, which may have an impact on stability and valve function over time. We, therefore, analyzed the midterm stability of the position, shape, and hemodynamic performance of the DFM percutaneous aortic valve.
METHODS AND RESULTS—Sixteen symptomatic high-risk for surgery patients with aortic stenosis and a logistic EuroSCORE >20 underwent implantation and were the subject of this analysis. Clinical, echocardiographic, and dual-source multislice computed tomography data were obtained during 2-year follow-up. The 1- and 2-year survival rates were 81% and 69%, respectively. The dual-source multislice computed tomography follow-up indicated no changes in position, diameter, and orifice area of the DFM valve over time. Echocardiography revealed a significant decrease of the mean gradient from baseline (50.1±11.3 mm Hg) to 30 days (19.6±5.7 mm Hg, P<0.001), which remained stable over 2 years. The aortic valve area increased from 0.57±0.15 cm at baseline to 1.47±0.35 cm at 30 days (P<0.001) and did not significantly change during 2-year follow-up. Of the patients, 73% had no aortic regurgitation (AR) and 27% had minimal AR.
CONCLUSIONS—In this preliminary series, the 2-year follow-up data of patients, in whom the nonmetallic, repositionable, and retrievable DFM valve was successfully implanted, show stability of the position, shape, and hemodynamic performance, with no AR in most patients.</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Angioplasty - methods</subject><subject>Aortic Valve - diagnostic imaging</subject><subject>Aortic Valve - physiology</subject><subject>Aortic Valve Stenosis - mortality</subject><subject>Aortic Valve Stenosis - physiopathology</subject><subject>Aortic Valve Stenosis - therapy</subject><subject>Biological and medical sciences</subject><subject>Blood and lymphatic vessels</subject><subject>Cardiology. Vascular system</subject><subject>Cardiovascular system</subject><subject>Diseases of the aorta</subject><subject>Echocardiography</subject><subject>Female</subject><subject>Femoral Vein</subject><subject>Follow-Up Studies</subject><subject>Heart Valve Prosthesis</subject><subject>Heart Valve Prosthesis Implantation - methods</subject><subject>Hemodynamics - physiology</subject><subject>Humans</subject><subject>Investigative techniques, diagnostic techniques (general aspects)</subject><subject>Kaplan-Meier Estimate</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Multidetector Computed Tomography</subject><subject>Orthopedic surgery</subject><subject>Pilot Projects</subject><subject>Regional Blood Flow - physiology</subject><subject>Severity of Illness Index</subject><subject>Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases</subject><subject>Treatment Outcome</subject><subject>Ultrasonic investigative techniques</subject><issn>1941-7640</issn><issn>1941-7632</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNplks1uEzEUhUcIREvhFZAXIDadYnsm40zVTRSSNlKbRklaxGrk2HcUg2ccbCdRnrxbbpsQFiysax1_98c-TpJPjF4wVrCv_dG0PxrPB9PHwXg-uh_PUGYXZZFTwV8lp6zMWSqKjL8-7nN6krwL4SelKBf8bXLCOeNdTvlp8nRndATfkFmUC2NN3BHZanIDjdO7VjZGkQn42vlGtgqIq4kkcy_bUCPhpbU7MmpWVraYboGMXdtARNmoczKF6A1sng_OX6pOYeWCica1L3DP-Yj1H6XdADEtmchooI2BfDdxSWawAX-EZhFazA2X5GFFoiM8_QHSk6Gz1m1T1HCyuATyzXhQMR2iSu5AGyXtvsEl6ZGJsS5iqbXevU_e1NIG-HCIZ8nDcDDv36S399ejfu82VbyTlalclJmWueAYlRalwNjlZcaFLDo6Y4scqKBKaFWoRZeqGgTnIDTXeVFSWmZnyZd93ZV3v9cQYtWYoMDii4Fbh6pkPOdlngskr_ak8i4ED3W18qaRflcxWj07X_3nPMqs2juP6R8PjdaLBvQx-a_VCHw-ADLgq9RoojLhH4fX7eAgyOV7buss_ozwy6634KslSBuXFWVZJvKyk3KKzTmlNMWFF_0DSBbM9g</recordid><startdate>201112</startdate><enddate>201112</enddate><creator>Bijuklic, Klaudija</creator><creator>Tuebler, Thilo</creator><creator>Reichenspurner, Hermann</creator><creator>Treede, Hendrik</creator><creator>Wandler, Andreas</creator><creator>Harreld, John H</creator><creator>Low, Reginald I</creator><creator>Schofer, Joachim</creator><general>American Heart Association, Inc</general><general>Lippincott Williams & Wilkins</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>201112</creationdate><title>Midterm Stability and Hemodynamic Performance of a Transfemorally Implantable Nonmetallic, Retrievable, and Repositionable Aortic Valve in Patients With Severe Aortic Stenosis: Up to 2-Year Follow-Up of the Direct-Flow Medical Valve: A Pilot Study</title><author>Bijuklic, Klaudija ; Tuebler, Thilo ; Reichenspurner, Hermann ; Treede, Hendrik ; Wandler, Andreas ; Harreld, John H ; Low, Reginald I ; Schofer, Joachim</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c2539-ab93da472b93cd797b93829327a65d31b4e070c7dc6cb80cfe722e7d2d4690093</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Angioplasty - methods</topic><topic>Aortic Valve - diagnostic imaging</topic><topic>Aortic Valve - physiology</topic><topic>Aortic Valve Stenosis - mortality</topic><topic>Aortic Valve Stenosis - physiopathology</topic><topic>Aortic Valve Stenosis - therapy</topic><topic>Biological and medical sciences</topic><topic>Blood and lymphatic vessels</topic><topic>Cardiology. Vascular system</topic><topic>Cardiovascular system</topic><topic>Diseases of the aorta</topic><topic>Echocardiography</topic><topic>Female</topic><topic>Femoral Vein</topic><topic>Follow-Up Studies</topic><topic>Heart Valve Prosthesis</topic><topic>Heart Valve Prosthesis Implantation - methods</topic><topic>Hemodynamics - physiology</topic><topic>Humans</topic><topic>Investigative techniques, diagnostic techniques (general aspects)</topic><topic>Kaplan-Meier Estimate</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Multidetector Computed Tomography</topic><topic>Orthopedic surgery</topic><topic>Pilot Projects</topic><topic>Regional Blood Flow - physiology</topic><topic>Severity of Illness Index</topic><topic>Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases</topic><topic>Treatment Outcome</topic><topic>Ultrasonic investigative techniques</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bijuklic, Klaudija</creatorcontrib><creatorcontrib>Tuebler, Thilo</creatorcontrib><creatorcontrib>Reichenspurner, Hermann</creatorcontrib><creatorcontrib>Treede, Hendrik</creatorcontrib><creatorcontrib>Wandler, Andreas</creatorcontrib><creatorcontrib>Harreld, John H</creatorcontrib><creatorcontrib>Low, Reginald I</creatorcontrib><creatorcontrib>Schofer, Joachim</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Circulation. Cardiovascular interventions</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bijuklic, Klaudija</au><au>Tuebler, Thilo</au><au>Reichenspurner, Hermann</au><au>Treede, Hendrik</au><au>Wandler, Andreas</au><au>Harreld, John H</au><au>Low, Reginald I</au><au>Schofer, Joachim</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Midterm Stability and Hemodynamic Performance of a Transfemorally Implantable Nonmetallic, Retrievable, and Repositionable Aortic Valve in Patients With Severe Aortic Stenosis: Up to 2-Year Follow-Up of the Direct-Flow Medical Valve: A Pilot Study</atitle><jtitle>Circulation. Cardiovascular interventions</jtitle><addtitle>Circ Cardiovasc Interv</addtitle><date>2011-12</date><risdate>2011</risdate><volume>4</volume><issue>6</issue><spage>595</spage><epage>601</epage><pages>595-601</pages><issn>1941-7640</issn><eissn>1941-7632</eissn><abstract>BACKGROUND—Misplacement during percutaneous aortic valve implantation can be associated with severe complications. The direct flow medical (DFM) valve is repositionable and retrievable; however, the nonmetallic inflatable and conformable design of the valve results in less radial force, which may have an impact on stability and valve function over time. We, therefore, analyzed the midterm stability of the position, shape, and hemodynamic performance of the DFM percutaneous aortic valve.
METHODS AND RESULTS—Sixteen symptomatic high-risk for surgery patients with aortic stenosis and a logistic EuroSCORE >20 underwent implantation and were the subject of this analysis. Clinical, echocardiographic, and dual-source multislice computed tomography data were obtained during 2-year follow-up. The 1- and 2-year survival rates were 81% and 69%, respectively. The dual-source multislice computed tomography follow-up indicated no changes in position, diameter, and orifice area of the DFM valve over time. Echocardiography revealed a significant decrease of the mean gradient from baseline (50.1±11.3 mm Hg) to 30 days (19.6±5.7 mm Hg, P<0.001), which remained stable over 2 years. The aortic valve area increased from 0.57±0.15 cm at baseline to 1.47±0.35 cm at 30 days (P<0.001) and did not significantly change during 2-year follow-up. Of the patients, 73% had no aortic regurgitation (AR) and 27% had minimal AR.
CONCLUSIONS—In this preliminary series, the 2-year follow-up data of patients, in whom the nonmetallic, repositionable, and retrievable DFM valve was successfully implanted, show stability of the position, shape, and hemodynamic performance, with no AR in most patients.</abstract><cop>Hagerstown, MD</cop><pub>American Heart Association, Inc</pub><pmid>22128202</pmid><doi>10.1161/CIRCINTERVENTIONS.111.964072</doi><tpages>7</tpages></addata></record> |
| fulltext | fulltext |
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| ispartof | Circulation. Cardiovascular interventions, 2011-12, Vol.4 (6), p.595-601 |
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| source | MEDLINE; EZB Electronic Journals Library; American Heart Association |
| subjects | Aged Aged, 80 and over Angioplasty - methods Aortic Valve - diagnostic imaging Aortic Valve - physiology Aortic Valve Stenosis - mortality Aortic Valve Stenosis - physiopathology Aortic Valve Stenosis - therapy Biological and medical sciences Blood and lymphatic vessels Cardiology. Vascular system Cardiovascular system Diseases of the aorta Echocardiography Female Femoral Vein Follow-Up Studies Heart Valve Prosthesis Heart Valve Prosthesis Implantation - methods Hemodynamics - physiology Humans Investigative techniques, diagnostic techniques (general aspects) Kaplan-Meier Estimate Male Medical sciences Multidetector Computed Tomography Orthopedic surgery Pilot Projects Regional Blood Flow - physiology Severity of Illness Index Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases Treatment Outcome Ultrasonic investigative techniques |
| title | Midterm Stability and Hemodynamic Performance of a Transfemorally Implantable Nonmetallic, Retrievable, and Repositionable Aortic Valve in Patients With Severe Aortic Stenosis: Up to 2-Year Follow-Up of the Direct-Flow Medical Valve: A Pilot Study |
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