Procedural Results and Clinical Outcomes of Transcatheter Aortic Valve Implantation in Switzerland: An Observational Cohort Study of Sapien 3 Versus Sapien XT Transcatheter Heart Valves
BACKGROUND—New generation transcatheter heart valves (THV) may improve clinical outcomes of transcatheter aortic valve implantation. METHODS AND RESULTS—In a nationwide, prospective, multicenter cohort study (Swiss Transcatheter Aortic Valve Implantation Registry, NCT01368250), outcomes of consecuti...
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| Veröffentlicht in: | Circulation. Cardiovascular interventions 2015-10, Vol.8 (10), p.e002653-e002653 |
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| creator | Binder, Ronald K Stortecky, Stefan Heg, Dik Tueller, David Jeger, Raban Toggweiler, Stefan Pedrazzini, Giovanni Amann, Franz W Ferrari, Enrico Noble, Stephane Nietlispach, Fabian Maisano, Francesco Räber, Lorenz Roffi, Marco Grünenfelder, Jürg Jüni, Peter Huber, Christoph Windecker, Stephan Wenaweser, Peter |
| description | BACKGROUND—New generation transcatheter heart valves (THV) may improve clinical outcomes of transcatheter aortic valve implantation.
METHODS AND RESULTS—In a nationwide, prospective, multicenter cohort study (Swiss Transcatheter Aortic Valve Implantation Registry, NCT01368250), outcomes of consecutive transfemoral transcatheter aortic valve implantation patients treated with the Sapien 3 THV (S3) versus the Sapien XT THV (XT) were investigated. An overall of 153 consecutive S3 patients were compared with 445 consecutive XT patients. Postprocedural mean transprosthetic gradient (6.5±3.0 versus 7.8±6.3 mm Hg, P=0.17) did not differ between S3 and XT patients, respectively. The rate of more than mild paravalvular regurgitation (1.3% versus 5.3%, P=0.04) and of vascular (5.3% versus 16.9%, P |
| doi_str_mv | 10.1161/CIRCINTERVENTIONS.115.002653 |
| format | Article |
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METHODS AND RESULTS—In a nationwide, prospective, multicenter cohort study (Swiss Transcatheter Aortic Valve Implantation Registry, NCT01368250), outcomes of consecutive transfemoral transcatheter aortic valve implantation patients treated with the Sapien 3 THV (S3) versus the Sapien XT THV (XT) were investigated. An overall of 153 consecutive S3 patients were compared with 445 consecutive XT patients. Postprocedural mean transprosthetic gradient (6.5±3.0 versus 7.8±6.3 mm Hg, P=0.17) did not differ between S3 and XT patients, respectively. The rate of more than mild paravalvular regurgitation (1.3% versus 5.3%, P=0.04) and of vascular (5.3% versus 16.9%, P<0.01) complications were significantly lower in S3 patients. A higher rate of new permanent pacemaker implantations was observed in patients receiving the S3 valve (17.0% versus 11.0%, P=0.01). There were no significant differences for disabling stroke (S3 1.3% versus XT 3.1%, P=0.29) and all-cause mortality (S3 3.3% versus XT 4.5%, P=0.27).
CONCLUSIONS—The use of the new generation S3 balloon-expandable THV reduced the risk of more than mild paravalvular regurgitation and vascular complications but was associated with an increased permanent pacemaker rate compared with the XT. Transcatheter aortic valve implantation using the newest generation balloon-expandable THV is associated with a low risk of stroke and favorable clinical outcomes.
CLINICAL TRIAL REGISTRATION—URLhttp://www.clinicaltrials.gov. Unique identifierNCT01368250.</description><identifier>ISSN: 1941-7640</identifier><identifier>EISSN: 1941-7632</identifier><identifier>DOI: 10.1161/CIRCINTERVENTIONS.115.002653</identifier><identifier>PMID: 26453687</identifier><language>eng</language><publisher>United States: American Heart Association, Inc</publisher><subject>Aged ; Aged, 80 and over ; Aortic Valve - surgery ; Aortic Valve Stenosis - epidemiology ; Aortic Valve Stenosis - surgery ; Cohort Studies ; Female ; Heart Valve Prosthesis - adverse effects ; Heart Valve Prosthesis - utilization ; Humans ; Male ; Postoperative Complications - epidemiology ; Postoperative Complications - prevention & control ; Prospective Studies ; Risk ; Switzerland ; Transcatheter Aortic Valve Replacement ; Treatment Outcome</subject><ispartof>Circulation. Cardiovascular interventions, 2015-10, Vol.8 (10), p.e002653-e002653</ispartof><rights>2015 American Heart Association, Inc.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c3093-a1e7e9e41f2bdcd0d17c9edc7585bde777d2c7659cdc686d97cbbb1822aadc983</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,3687,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26453687$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Binder, Ronald K</creatorcontrib><creatorcontrib>Stortecky, Stefan</creatorcontrib><creatorcontrib>Heg, Dik</creatorcontrib><creatorcontrib>Tueller, David</creatorcontrib><creatorcontrib>Jeger, Raban</creatorcontrib><creatorcontrib>Toggweiler, Stefan</creatorcontrib><creatorcontrib>Pedrazzini, Giovanni</creatorcontrib><creatorcontrib>Amann, Franz W</creatorcontrib><creatorcontrib>Ferrari, Enrico</creatorcontrib><creatorcontrib>Noble, Stephane</creatorcontrib><creatorcontrib>Nietlispach, Fabian</creatorcontrib><creatorcontrib>Maisano, Francesco</creatorcontrib><creatorcontrib>Räber, Lorenz</creatorcontrib><creatorcontrib>Roffi, Marco</creatorcontrib><creatorcontrib>Grünenfelder, Jürg</creatorcontrib><creatorcontrib>Jüni, Peter</creatorcontrib><creatorcontrib>Huber, Christoph</creatorcontrib><creatorcontrib>Windecker, Stephan</creatorcontrib><creatorcontrib>Wenaweser, Peter</creatorcontrib><title>Procedural Results and Clinical Outcomes of Transcatheter Aortic Valve Implantation in Switzerland: An Observational Cohort Study of Sapien 3 Versus Sapien XT Transcatheter Heart Valves</title><title>Circulation. Cardiovascular interventions</title><addtitle>Circ Cardiovasc Interv</addtitle><description>BACKGROUND—New generation transcatheter heart valves (THV) may improve clinical outcomes of transcatheter aortic valve implantation.
METHODS AND RESULTS—In a nationwide, prospective, multicenter cohort study (Swiss Transcatheter Aortic Valve Implantation Registry, NCT01368250), outcomes of consecutive transfemoral transcatheter aortic valve implantation patients treated with the Sapien 3 THV (S3) versus the Sapien XT THV (XT) were investigated. An overall of 153 consecutive S3 patients were compared with 445 consecutive XT patients. Postprocedural mean transprosthetic gradient (6.5±3.0 versus 7.8±6.3 mm Hg, P=0.17) did not differ between S3 and XT patients, respectively. The rate of more than mild paravalvular regurgitation (1.3% versus 5.3%, P=0.04) and of vascular (5.3% versus 16.9%, P<0.01) complications were significantly lower in S3 patients. A higher rate of new permanent pacemaker implantations was observed in patients receiving the S3 valve (17.0% versus 11.0%, P=0.01). There were no significant differences for disabling stroke (S3 1.3% versus XT 3.1%, P=0.29) and all-cause mortality (S3 3.3% versus XT 4.5%, P=0.27).
CONCLUSIONS—The use of the new generation S3 balloon-expandable THV reduced the risk of more than mild paravalvular regurgitation and vascular complications but was associated with an increased permanent pacemaker rate compared with the XT. Transcatheter aortic valve implantation using the newest generation balloon-expandable THV is associated with a low risk of stroke and favorable clinical outcomes.
CLINICAL TRIAL REGISTRATION—URLhttp://www.clinicaltrials.gov. Unique identifierNCT01368250.</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Aortic Valve - surgery</subject><subject>Aortic Valve Stenosis - epidemiology</subject><subject>Aortic Valve Stenosis - surgery</subject><subject>Cohort Studies</subject><subject>Female</subject><subject>Heart Valve Prosthesis - adverse effects</subject><subject>Heart Valve Prosthesis - utilization</subject><subject>Humans</subject><subject>Male</subject><subject>Postoperative Complications - epidemiology</subject><subject>Postoperative Complications - prevention & control</subject><subject>Prospective Studies</subject><subject>Risk</subject><subject>Switzerland</subject><subject>Transcatheter Aortic Valve Replacement</subject><subject>Treatment Outcome</subject><issn>1941-7640</issn><issn>1941-7632</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNplUU9v0zActRCIjcFXQD5w4JJhO4mdIC5VVFikqUVtqLhFjv2rGnDiYjurtm-2b4e7bjuAJcv28_sj-yH0gZJLSjn9VNWrql4089Vmvmjq5WId4fySEMbz9AU6p2VGE8FT9vJ5n5Ez9Mb7X4REmLPX6IzxLE95Ic7R_XdnFejJSYNX4CcTPJajxpXpx15FcDkFZQfw2G5x4-TolQw7CODwzLrQK7yR5gZwPeyNHIMMvR1xP-L1oQ934CKmP-PZiJedB3fzcB1NK7uLYrwOk749Gq_lvocRp3gDzk_-6fyz-SfyCmSUPST6t-jVVhoP7x7XC_Tj67yprpLr5be6ml0nKiVlmkgKAkrI6JZ1WmmiqVAlaCXyIu80CCE0U4LnpdKKF1yXQnVdRwvGpNSqLNIL9PHku3f2zwQ-tEPvFZj4NLCTb6lgjBac8SP1y4mqnPXewbbdu36Q7ralpD2W1_5XXoTz9lRelL9_TJq6AfSz-KmtSMhOhIM18Tv8bzMdwLU7kCbsWkLTVGRlnjBCc0riSOKM4F-F9ayq</recordid><startdate>201510</startdate><enddate>201510</enddate><creator>Binder, Ronald K</creator><creator>Stortecky, Stefan</creator><creator>Heg, Dik</creator><creator>Tueller, David</creator><creator>Jeger, Raban</creator><creator>Toggweiler, Stefan</creator><creator>Pedrazzini, Giovanni</creator><creator>Amann, Franz W</creator><creator>Ferrari, Enrico</creator><creator>Noble, Stephane</creator><creator>Nietlispach, Fabian</creator><creator>Maisano, Francesco</creator><creator>Räber, Lorenz</creator><creator>Roffi, Marco</creator><creator>Grünenfelder, Jürg</creator><creator>Jüni, Peter</creator><creator>Huber, Christoph</creator><creator>Windecker, Stephan</creator><creator>Wenaweser, Peter</creator><general>American Heart Association, Inc</general><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>201510</creationdate><title>Procedural Results and Clinical Outcomes of Transcatheter Aortic Valve Implantation in Switzerland: An Observational Cohort Study of Sapien 3 Versus Sapien XT Transcatheter Heart Valves</title><author>Binder, Ronald K ; Stortecky, Stefan ; Heg, Dik ; Tueller, David ; Jeger, Raban ; Toggweiler, Stefan ; Pedrazzini, Giovanni ; Amann, Franz W ; Ferrari, Enrico ; Noble, Stephane ; Nietlispach, Fabian ; Maisano, Francesco ; Räber, Lorenz ; Roffi, Marco ; Grünenfelder, Jürg ; Jüni, Peter ; Huber, Christoph ; Windecker, Stephan ; Wenaweser, Peter</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3093-a1e7e9e41f2bdcd0d17c9edc7585bde777d2c7659cdc686d97cbbb1822aadc983</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Aortic Valve - surgery</topic><topic>Aortic Valve Stenosis - epidemiology</topic><topic>Aortic Valve Stenosis - surgery</topic><topic>Cohort Studies</topic><topic>Female</topic><topic>Heart Valve Prosthesis - adverse effects</topic><topic>Heart Valve Prosthesis - utilization</topic><topic>Humans</topic><topic>Male</topic><topic>Postoperative Complications - epidemiology</topic><topic>Postoperative Complications - prevention & control</topic><topic>Prospective Studies</topic><topic>Risk</topic><topic>Switzerland</topic><topic>Transcatheter Aortic Valve Replacement</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Binder, Ronald K</creatorcontrib><creatorcontrib>Stortecky, Stefan</creatorcontrib><creatorcontrib>Heg, Dik</creatorcontrib><creatorcontrib>Tueller, David</creatorcontrib><creatorcontrib>Jeger, Raban</creatorcontrib><creatorcontrib>Toggweiler, Stefan</creatorcontrib><creatorcontrib>Pedrazzini, Giovanni</creatorcontrib><creatorcontrib>Amann, Franz W</creatorcontrib><creatorcontrib>Ferrari, Enrico</creatorcontrib><creatorcontrib>Noble, Stephane</creatorcontrib><creatorcontrib>Nietlispach, Fabian</creatorcontrib><creatorcontrib>Maisano, Francesco</creatorcontrib><creatorcontrib>Räber, Lorenz</creatorcontrib><creatorcontrib>Roffi, Marco</creatorcontrib><creatorcontrib>Grünenfelder, Jürg</creatorcontrib><creatorcontrib>Jüni, Peter</creatorcontrib><creatorcontrib>Huber, Christoph</creatorcontrib><creatorcontrib>Windecker, Stephan</creatorcontrib><creatorcontrib>Wenaweser, Peter</creatorcontrib><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>Binder, Ronald K</au><au>Stortecky, Stefan</au><au>Heg, Dik</au><au>Tueller, David</au><au>Jeger, Raban</au><au>Toggweiler, Stefan</au><au>Pedrazzini, Giovanni</au><au>Amann, Franz W</au><au>Ferrari, Enrico</au><au>Noble, Stephane</au><au>Nietlispach, Fabian</au><au>Maisano, Francesco</au><au>Räber, Lorenz</au><au>Roffi, Marco</au><au>Grünenfelder, Jürg</au><au>Jüni, Peter</au><au>Huber, Christoph</au><au>Windecker, Stephan</au><au>Wenaweser, Peter</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Procedural Results and Clinical Outcomes of Transcatheter Aortic Valve Implantation in Switzerland: An Observational Cohort Study of Sapien 3 Versus Sapien XT Transcatheter Heart Valves</atitle><jtitle>Circulation. Cardiovascular interventions</jtitle><addtitle>Circ Cardiovasc Interv</addtitle><date>2015-10</date><risdate>2015</risdate><volume>8</volume><issue>10</issue><spage>e002653</spage><epage>e002653</epage><pages>e002653-e002653</pages><issn>1941-7640</issn><eissn>1941-7632</eissn><abstract>BACKGROUND—New generation transcatheter heart valves (THV) may improve clinical outcomes of transcatheter aortic valve implantation.
METHODS AND RESULTS—In a nationwide, prospective, multicenter cohort study (Swiss Transcatheter Aortic Valve Implantation Registry, NCT01368250), outcomes of consecutive transfemoral transcatheter aortic valve implantation patients treated with the Sapien 3 THV (S3) versus the Sapien XT THV (XT) were investigated. An overall of 153 consecutive S3 patients were compared with 445 consecutive XT patients. Postprocedural mean transprosthetic gradient (6.5±3.0 versus 7.8±6.3 mm Hg, P=0.17) did not differ between S3 and XT patients, respectively. The rate of more than mild paravalvular regurgitation (1.3% versus 5.3%, P=0.04) and of vascular (5.3% versus 16.9%, P<0.01) complications were significantly lower in S3 patients. A higher rate of new permanent pacemaker implantations was observed in patients receiving the S3 valve (17.0% versus 11.0%, P=0.01). There were no significant differences for disabling stroke (S3 1.3% versus XT 3.1%, P=0.29) and all-cause mortality (S3 3.3% versus XT 4.5%, P=0.27).
CONCLUSIONS—The use of the new generation S3 balloon-expandable THV reduced the risk of more than mild paravalvular regurgitation and vascular complications but was associated with an increased permanent pacemaker rate compared with the XT. Transcatheter aortic valve implantation using the newest generation balloon-expandable THV is associated with a low risk of stroke and favorable clinical outcomes.
CLINICAL TRIAL REGISTRATION—URLhttp://www.clinicaltrials.gov. Unique identifierNCT01368250.</abstract><cop>United States</cop><pub>American Heart Association, Inc</pub><pmid>26453687</pmid><doi>10.1161/CIRCINTERVENTIONS.115.002653</doi><oa>free_for_read</oa></addata></record> |
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| ispartof | Circulation. Cardiovascular interventions, 2015-10, Vol.8 (10), p.e002653-e002653 |
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| language | eng |
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| source | MEDLINE; American Heart Association Journals; EZB-FREE-00999 freely available EZB journals |
| subjects | Aged Aged, 80 and over Aortic Valve - surgery Aortic Valve Stenosis - epidemiology Aortic Valve Stenosis - surgery Cohort Studies Female Heart Valve Prosthesis - adverse effects Heart Valve Prosthesis - utilization Humans Male Postoperative Complications - epidemiology Postoperative Complications - prevention & control Prospective Studies Risk Switzerland Transcatheter Aortic Valve Replacement Treatment Outcome |
| title | Procedural Results and Clinical Outcomes of Transcatheter Aortic Valve Implantation in Switzerland: An Observational Cohort Study of Sapien 3 Versus Sapien XT Transcatheter Heart Valves |
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