Outcomes of Patients at Estimated Low, Intermediate, and High Risk Undergoing Transcatheter Aortic Valve Implantation for Aortic Stenosis
Intermediate- or low-risk patients with severe aortic stenosis were excluded from earlier transcatheter aortic valve implantation (TAVI) clinical trials; however, they are already being treated by TAVI despite a lack of data regarding the safety and efficacy in these patients. We aimed to assess the...
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| Veröffentlicht in: | The American journal of cardiology 2015-12, Vol.116 (12), p.1916-1922 |
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| creator | Barbash, Israel Moshe, MD Finkelstein, Ariel, MD Barsheshet, Alon, MD Segev, Amit, MD Steinvil, Arie, MD Assali, Abid, MD Ben Gal, Yanai, MD Vaknin Assa, Hana, MD Fefer, Paul, MD Sagie, Alex, MD Guetta, Victor, MD Kornowski, Ran, MD |
| description | Intermediate- or low-risk patients with severe aortic stenosis were excluded from earlier transcatheter aortic valve implantation (TAVI) clinical trials; however, they are already being treated by TAVI despite a lack of data regarding the safety and efficacy in these patients. We aimed to assess the safety and efficacy of TAVI in patients at intermediate or low risk. Patients undergoing TAVI during 2008 to 2014 were included into a shared database (n = 1,327). Procedural outcomes were adjudicated according to Valve Academic Research Consortium 2 definitions. Patients were stratified according to their Society of Thoracic Surgeons (STS) score into 3 groups: high (STS ≥8, n = 223, 17%), intermediate (STS 4 to 8; n = 496, 38%), or low risk (STS |
| doi_str_mv | 10.1016/j.amjcard.2015.09.030 |
| format | Article |
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We aimed to assess the safety and efficacy of TAVI in patients at intermediate or low risk. Patients undergoing TAVI during 2008 to 2014 were included into a shared database (n = 1,327). Procedural outcomes were adjudicated according to Valve Academic Research Consortium 2 definitions. Patients were stratified according to their Society of Thoracic Surgeons (STS) score into 3 groups: high (STS ≥8, n = 223, 17%), intermediate (STS 4 to 8; n = 496, 38%), or low risk (STS <4; n = 576, 45%). Low-risk patients were significantly younger and more likely to be men compared to intermediate- and high-risk patients. Baseline characteristics differed significantly between the groups with a gradual increase in the rates of previous bypass surgery, stroke, peripheral vascular disease, renal failure, lung disease, and frailty scores, from low to high risk groups. Compared with intermediate- and high-risk patients, low-risk patients were more likely to undergo TAVI through the transfemoral route (81% vs 88% vs 95%, p <0.001) and under conscious sedation (69% vs 72% vs 81%, <0.001). There were no significant differences in the rates of procedural complications apart from acute kidney injury (19% vs 17% vs 13%, p = 0.03) and stroke rates (4.5% vs 2% vs 2.3%, p = 0.1). Short- and long-term mortality rates were significantly higher for intermediate- (hazard ratio [HR] 1.9, 95% confidence interval [CI] 1.2 to 2.9) and high-risk patients (HR 4.1, 95% CI 2.7 to 6.4) than low-risk patients also after multivariate adjustment (HR 1.6, 95% CI 1 to 2.6 and HR 2.7, 95% CI 1.7 to 4.5, respectively; all p <0.05). In conclusion, TAVI for intermediate- and low-risk patients is safe and associated with improved outcome compared with high-risk patients.</description><identifier>ISSN: 0002-9149</identifier><identifier>EISSN: 1879-1913</identifier><identifier>DOI: 10.1016/j.amjcard.2015.09.030</identifier><identifier>PMID: 26602076</identifier><identifier>CODEN: AJCDAG</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Aged ; Aged, 80 and over ; Aortic Valve Stenosis - mortality ; Aortic Valve Stenosis - surgery ; Cardiovascular ; Female ; Follow-Up Studies ; Heart attacks ; Hospitalization ; Hospitals ; Humans ; Israel - epidemiology ; Laboratories ; Male ; Mortality ; Ostomy ; Patients ; Physicians ; Prospective Studies ; Pulmonary arteries ; Risk Assessment - methods ; Risk Factors ; Stroke ; Studies ; Success ; Survival Rate - trends ; Time Factors ; Transcatheter Aortic Valve Replacement ; Treatment Outcome ; Variables</subject><ispartof>The American journal of cardiology, 2015-12, Vol.116 (12), p.1916-1922</ispartof><rights>Elsevier Inc.</rights><rights>2015 Elsevier Inc.</rights><rights>Copyright © 2015 Elsevier Inc. All rights reserved.</rights><rights>Copyright Elsevier Limited Dec 15, 2015</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c617t-e95693f0a315b3237d2c68e14bee97e29ac93ebe95e38c2002f0b35a65103ba03</citedby><cites>FETCH-LOGICAL-c617t-e95693f0a315b3237d2c68e14bee97e29ac93ebe95e38c2002f0b35a65103ba03</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/1738445652?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,776,780,3536,27903,27904,45974,64362,64364,64366,72216</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26602076$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Barbash, Israel Moshe, MD</creatorcontrib><creatorcontrib>Finkelstein, Ariel, MD</creatorcontrib><creatorcontrib>Barsheshet, Alon, MD</creatorcontrib><creatorcontrib>Segev, Amit, MD</creatorcontrib><creatorcontrib>Steinvil, Arie, MD</creatorcontrib><creatorcontrib>Assali, Abid, MD</creatorcontrib><creatorcontrib>Ben Gal, Yanai, MD</creatorcontrib><creatorcontrib>Vaknin Assa, Hana, MD</creatorcontrib><creatorcontrib>Fefer, Paul, MD</creatorcontrib><creatorcontrib>Sagie, Alex, MD</creatorcontrib><creatorcontrib>Guetta, Victor, MD</creatorcontrib><creatorcontrib>Kornowski, Ran, MD</creatorcontrib><title>Outcomes of Patients at Estimated Low, Intermediate, and High Risk Undergoing Transcatheter Aortic Valve Implantation for Aortic Stenosis</title><title>The American journal of cardiology</title><addtitle>Am J Cardiol</addtitle><description>Intermediate- or low-risk patients with severe aortic stenosis were excluded from earlier transcatheter aortic valve implantation (TAVI) clinical trials; however, they are already being treated by TAVI despite a lack of data regarding the safety and efficacy in these patients. We aimed to assess the safety and efficacy of TAVI in patients at intermediate or low risk. Patients undergoing TAVI during 2008 to 2014 were included into a shared database (n = 1,327). Procedural outcomes were adjudicated according to Valve Academic Research Consortium 2 definitions. Patients were stratified according to their Society of Thoracic Surgeons (STS) score into 3 groups: high (STS ≥8, n = 223, 17%), intermediate (STS 4 to 8; n = 496, 38%), or low risk (STS <4; n = 576, 45%). Low-risk patients were significantly younger and more likely to be men compared to intermediate- and high-risk patients. Baseline characteristics differed significantly between the groups with a gradual increase in the rates of previous bypass surgery, stroke, peripheral vascular disease, renal failure, lung disease, and frailty scores, from low to high risk groups. Compared with intermediate- and high-risk patients, low-risk patients were more likely to undergo TAVI through the transfemoral route (81% vs 88% vs 95%, p <0.001) and under conscious sedation (69% vs 72% vs 81%, <0.001). There were no significant differences in the rates of procedural complications apart from acute kidney injury (19% vs 17% vs 13%, p = 0.03) and stroke rates (4.5% vs 2% vs 2.3%, p = 0.1). Short- and long-term mortality rates were significantly higher for intermediate- (hazard ratio [HR] 1.9, 95% confidence interval [CI] 1.2 to 2.9) and high-risk patients (HR 4.1, 95% CI 2.7 to 6.4) than low-risk patients also after multivariate adjustment (HR 1.6, 95% CI 1 to 2.6 and HR 2.7, 95% CI 1.7 to 4.5, respectively; all p <0.05). In conclusion, TAVI for intermediate- and low-risk patients is safe and associated with improved outcome compared with high-risk patients.</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Aortic Valve Stenosis - mortality</subject><subject>Aortic Valve Stenosis - surgery</subject><subject>Cardiovascular</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Heart attacks</subject><subject>Hospitalization</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Israel - epidemiology</subject><subject>Laboratories</subject><subject>Male</subject><subject>Mortality</subject><subject>Ostomy</subject><subject>Patients</subject><subject>Physicians</subject><subject>Prospective Studies</subject><subject>Pulmonary arteries</subject><subject>Risk Assessment - methods</subject><subject>Risk Factors</subject><subject>Stroke</subject><subject>Studies</subject><subject>Success</subject><subject>Survival Rate - trends</subject><subject>Time Factors</subject><subject>Transcatheter Aortic Valve Replacement</subject><subject>Treatment Outcome</subject><subject>Variables</subject><issn>0002-9149</issn><issn>1879-1913</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqNkstu1DAUhi0EosPAI4AssWHRDL4kTrwBVVWhI41URFu2luOcTD1N7KntFPUReGs8mqFI3cDKsv2d_1z-g9BbShaUUPFxs9DjxujQLRih1YLIBeHkGZrRppYFlZQ_RzNCCCskLeURehXjJl8prcRLdMSEIIzUYoZ-XUzJ-BEi9j3-ppMFlyLWCZ_FZEedoMMr__MYL12CMEJn89Mx1q7D53Z9g7_beIuvXQdh7a1b46ugXTQ63UDG8YkPyRr8Qw_3gJfjdtAu5RTe4d4__l4mcD7a-Bq96PUQ4c3hnKPrL2dXp-fF6uLr8vRkVRhB61SArITkPdGcVi1nvO6YEQ3QsgWQNTCpjeTQZgx4Y1ieQE9aXmlRUcJbTfgcfdjrboO_myAmNdpoYMjFgZ-ionVTMd4I0vwHyuuyriWjGX3_BN34KbjcyI5qyrISWXWOqj1lgo8xQK-2IU85PChK1M5WtVEHW9XOVkWkyrbmuHcH9anNJjxG_fExA5_3AOTJ3VsIKppspcmGBTBJdd7-M8WnJwpmsM4aPdzCA8S_3ajIFFGXu93arRatcgVEcv4bF9TKrg</recordid><startdate>20151215</startdate><enddate>20151215</enddate><creator>Barbash, Israel Moshe, MD</creator><creator>Finkelstein, Ariel, MD</creator><creator>Barsheshet, Alon, MD</creator><creator>Segev, Amit, MD</creator><creator>Steinvil, Arie, MD</creator><creator>Assali, Abid, MD</creator><creator>Ben Gal, Yanai, MD</creator><creator>Vaknin Assa, Hana, MD</creator><creator>Fefer, Paul, MD</creator><creator>Sagie, Alex, MD</creator><creator>Guetta, Victor, MD</creator><creator>Kornowski, Ran, MD</creator><general>Elsevier Inc</general><general>Elsevier Limited</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>3V.</scope><scope>7RV</scope><scope>7TS</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>M2O</scope><scope>M7Z</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope><scope>7QO</scope></search><sort><creationdate>20151215</creationdate><title>Outcomes of Patients at Estimated Low, Intermediate, and High Risk Undergoing Transcatheter Aortic Valve Implantation for Aortic Stenosis</title><author>Barbash, Israel Moshe, MD ; Finkelstein, Ariel, MD ; Barsheshet, Alon, MD ; Segev, Amit, MD ; Steinvil, Arie, MD ; Assali, Abid, MD ; Ben Gal, Yanai, MD ; Vaknin Assa, Hana, MD ; Fefer, Paul, MD ; Sagie, Alex, MD ; Guetta, Victor, MD ; Kornowski, Ran, MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c617t-e95693f0a315b3237d2c68e14bee97e29ac93ebe95e38c2002f0b35a65103ba03</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 Stenosis - mortality</topic><topic>Aortic Valve Stenosis - surgery</topic><topic>Cardiovascular</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Heart attacks</topic><topic>Hospitalization</topic><topic>Hospitals</topic><topic>Humans</topic><topic>Israel - epidemiology</topic><topic>Laboratories</topic><topic>Male</topic><topic>Mortality</topic><topic>Ostomy</topic><topic>Patients</topic><topic>Physicians</topic><topic>Prospective Studies</topic><topic>Pulmonary arteries</topic><topic>Risk Assessment - methods</topic><topic>Risk Factors</topic><topic>Stroke</topic><topic>Studies</topic><topic>Success</topic><topic>Survival Rate - trends</topic><topic>Time Factors</topic><topic>Transcatheter Aortic Valve Replacement</topic><topic>Treatment Outcome</topic><topic>Variables</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Barbash, Israel Moshe, MD</creatorcontrib><creatorcontrib>Finkelstein, Ariel, MD</creatorcontrib><creatorcontrib>Barsheshet, Alon, MD</creatorcontrib><creatorcontrib>Segev, Amit, MD</creatorcontrib><creatorcontrib>Steinvil, Arie, MD</creatorcontrib><creatorcontrib>Assali, Abid, MD</creatorcontrib><creatorcontrib>Ben Gal, Yanai, MD</creatorcontrib><creatorcontrib>Vaknin Assa, Hana, MD</creatorcontrib><creatorcontrib>Fefer, Paul, MD</creatorcontrib><creatorcontrib>Sagie, Alex, MD</creatorcontrib><creatorcontrib>Guetta, Victor, MD</creatorcontrib><creatorcontrib>Kornowski, Ran, MD</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Physical Education Index</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Biochemistry Abstracts 1</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>Biotechnology Research Abstracts</collection><jtitle>The American journal of cardiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Barbash, Israel Moshe, MD</au><au>Finkelstein, Ariel, MD</au><au>Barsheshet, Alon, MD</au><au>Segev, Amit, MD</au><au>Steinvil, Arie, MD</au><au>Assali, Abid, MD</au><au>Ben Gal, Yanai, MD</au><au>Vaknin Assa, Hana, MD</au><au>Fefer, Paul, MD</au><au>Sagie, Alex, MD</au><au>Guetta, Victor, MD</au><au>Kornowski, Ran, MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Outcomes of Patients at Estimated Low, Intermediate, and High Risk Undergoing Transcatheter Aortic Valve Implantation for Aortic Stenosis</atitle><jtitle>The American journal of cardiology</jtitle><addtitle>Am J Cardiol</addtitle><date>2015-12-15</date><risdate>2015</risdate><volume>116</volume><issue>12</issue><spage>1916</spage><epage>1922</epage><pages>1916-1922</pages><issn>0002-9149</issn><eissn>1879-1913</eissn><coden>AJCDAG</coden><abstract>Intermediate- or low-risk patients with severe aortic stenosis were excluded from earlier transcatheter aortic valve implantation (TAVI) clinical trials; however, they are already being treated by TAVI despite a lack of data regarding the safety and efficacy in these patients. We aimed to assess the safety and efficacy of TAVI in patients at intermediate or low risk. Patients undergoing TAVI during 2008 to 2014 were included into a shared database (n = 1,327). Procedural outcomes were adjudicated according to Valve Academic Research Consortium 2 definitions. Patients were stratified according to their Society of Thoracic Surgeons (STS) score into 3 groups: high (STS ≥8, n = 223, 17%), intermediate (STS 4 to 8; n = 496, 38%), or low risk (STS <4; n = 576, 45%). Low-risk patients were significantly younger and more likely to be men compared to intermediate- and high-risk patients. Baseline characteristics differed significantly between the groups with a gradual increase in the rates of previous bypass surgery, stroke, peripheral vascular disease, renal failure, lung disease, and frailty scores, from low to high risk groups. Compared with intermediate- and high-risk patients, low-risk patients were more likely to undergo TAVI through the transfemoral route (81% vs 88% vs 95%, p <0.001) and under conscious sedation (69% vs 72% vs 81%, <0.001). There were no significant differences in the rates of procedural complications apart from acute kidney injury (19% vs 17% vs 13%, p = 0.03) and stroke rates (4.5% vs 2% vs 2.3%, p = 0.1). Short- and long-term mortality rates were significantly higher for intermediate- (hazard ratio [HR] 1.9, 95% confidence interval [CI] 1.2 to 2.9) and high-risk patients (HR 4.1, 95% CI 2.7 to 6.4) than low-risk patients also after multivariate adjustment (HR 1.6, 95% CI 1 to 2.6 and HR 2.7, 95% CI 1.7 to 4.5, respectively; all p <0.05). In conclusion, TAVI for intermediate- and low-risk patients is safe and associated with improved outcome compared with high-risk patients.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>26602076</pmid><doi>10.1016/j.amjcard.2015.09.030</doi><tpages>7</tpages></addata></record> |
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| subjects | Aged Aged, 80 and over Aortic Valve Stenosis - mortality Aortic Valve Stenosis - surgery Cardiovascular Female Follow-Up Studies Heart attacks Hospitalization Hospitals Humans Israel - epidemiology Laboratories Male Mortality Ostomy Patients Physicians Prospective Studies Pulmonary arteries Risk Assessment - methods Risk Factors Stroke Studies Success Survival Rate - trends Time Factors Transcatheter Aortic Valve Replacement Treatment Outcome Variables |
| title | Outcomes of Patients at Estimated Low, Intermediate, and High Risk Undergoing Transcatheter Aortic Valve Implantation for Aortic Stenosis |
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