Outcomes after transaortic transcatheter aortic valve implantation: long-term findings from the European ROUTE
Abstract OBJECTIVES There is lack of data regarding the longer-term outcomes of patients undergoing transaortic (TAo) transcatheter aortic valve implantation (TAVI). We aimed to provide a contemporary snapshot of the types and frequencies of events in the year following TAo-TAVI. METHODS The Registr...
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Veröffentlicht in: | European journal of cardio-thoracic surgery 2019-04, Vol.55 (4), p.737-743 |
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creator | Cocchieri, Riccardo Petzina, Rainer Romano, Mauro Jagielak, Dariusz Bonaros, Nikolaos Aiello, Marco Lapeze, Joel Laine, Mika Chocron, Sidney Muir, Douglas Eichinger, Walter Thielmann, Matthias Labrousse, Louis Rein, Kjell Arne Verhoye, Jean-Philippe Gerosa, Gino Bapat, Vinayak Baumbach, Hardy Sims, Helen Deutsch, Cornelia Bramlage, Peter Kurucova, Jana Thoenes, Martin Frank, Derk |
description | Abstract
OBJECTIVES
There is lack of data regarding the longer-term outcomes of patients undergoing transaortic (TAo) transcatheter aortic valve implantation (TAVI). We aimed to provide a contemporary snapshot of the types and frequencies of events in the year following TAo-TAVI.
METHODS
The Registry of the Utilization of the TAo-TAVI approach using the Edwards SAPIEN Valve (ROUTE) is a multicentre, European, prospective, observational registry of aortic stenosis patients undergoing TAo-TAVI. Patients were grouped according to the composite end point death, myocardial infarction, stroke/transient ischaemic attack, major vascular complications, life-threatening bleeding, acute kidney injury (AKI) and/or cardiovascular rehospitalization.
RESULTS
Two hundred and fifty-three patients with a mean age of 81.5 ± 5.8 years were included, of whom 89 (35.2%) patients met the composite end point (the event group) and 164 (64.8%) patients did not (the event-free group). New York Heart Association (NYHA) class III/IV (85.2% vs 71.8%, P = 0.017), Canadian Cardiovascular Society angina class III/IV (22.6% vs 11.4%; P = 0.021), pulmonary disease (32.6% vs 18.9%; P = 0.015) and renal insufficiency (15.7% vs 3.0%; P |
doi_str_mv | 10.1093/ejcts/ezy333 |
format | Article |
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OBJECTIVES
There is lack of data regarding the longer-term outcomes of patients undergoing transaortic (TAo) transcatheter aortic valve implantation (TAVI). We aimed to provide a contemporary snapshot of the types and frequencies of events in the year following TAo-TAVI.
METHODS
The Registry of the Utilization of the TAo-TAVI approach using the Edwards SAPIEN Valve (ROUTE) is a multicentre, European, prospective, observational registry of aortic stenosis patients undergoing TAo-TAVI. Patients were grouped according to the composite end point death, myocardial infarction, stroke/transient ischaemic attack, major vascular complications, life-threatening bleeding, acute kidney injury (AKI) and/or cardiovascular rehospitalization.
RESULTS
Two hundred and fifty-three patients with a mean age of 81.5 ± 5.8 years were included, of whom 89 (35.2%) patients met the composite end point (the event group) and 164 (64.8%) patients did not (the event-free group). New York Heart Association (NYHA) class III/IV (85.2% vs 71.8%, P = 0.017), Canadian Cardiovascular Society angina class III/IV (22.6% vs 11.4%; P = 0.021), pulmonary disease (32.6% vs 18.9%; P = 0.015) and renal insufficiency (15.7% vs 3.0%; P < 0.001) were more common in the event group. At 1 year, the most common event was death (19.1%), followed by AKI stage II or III (14.7%). The baseline renal insufficiency was the strongest independent predictor of composite end point achievement [odds ratio (OR) 7.55, 95% confidence interval (CI) 2.33–24.56], followed by NYHA class III/IV (OR 2.316, 95% CI 1.06–5.06) and pulmonary disease (OR 2.91, 95% CI 1.45–5.85). Pulmonary disease was also an independent predictor of 1-year mortality (OR 3.01, 95% CI 1.34–6.75).
CONCLUSIONS
Long-term outcomes after TAo-TAVI appear to be similar to those for TAVI via other non-transfemoral access routes. Awareness of characteristics associated with poorer outcomes may aid patient selection and identification of those requiring closer post-procedural monitoring.
Clinical trial registration number
ClinicalTrials.gov identifier: NCT01991431.</description><identifier>ISSN: 1010-7940</identifier><identifier>EISSN: 1873-734X</identifier><identifier>DOI: 10.1093/ejcts/ezy333</identifier><identifier>PMID: 30346515</identifier><language>eng</language><publisher>Germany: Oxford University Press</publisher><ispartof>European journal of cardio-thoracic surgery, 2019-04, Vol.55 (4), p.737-743</ispartof><rights>The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved. 2018</rights><rights>The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c361t-388e3ab1a5acaef33f92d72fe658e19951c107d8d993681650fbb41402a8331a3</citedby><cites>FETCH-LOGICAL-c361t-388e3ab1a5acaef33f92d72fe658e19951c107d8d993681650fbb41402a8331a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,781,785,1585,27929,27930</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30346515$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Cocchieri, Riccardo</creatorcontrib><creatorcontrib>Petzina, Rainer</creatorcontrib><creatorcontrib>Romano, Mauro</creatorcontrib><creatorcontrib>Jagielak, Dariusz</creatorcontrib><creatorcontrib>Bonaros, Nikolaos</creatorcontrib><creatorcontrib>Aiello, Marco</creatorcontrib><creatorcontrib>Lapeze, Joel</creatorcontrib><creatorcontrib>Laine, Mika</creatorcontrib><creatorcontrib>Chocron, Sidney</creatorcontrib><creatorcontrib>Muir, Douglas</creatorcontrib><creatorcontrib>Eichinger, Walter</creatorcontrib><creatorcontrib>Thielmann, Matthias</creatorcontrib><creatorcontrib>Labrousse, Louis</creatorcontrib><creatorcontrib>Rein, Kjell Arne</creatorcontrib><creatorcontrib>Verhoye, Jean-Philippe</creatorcontrib><creatorcontrib>Gerosa, Gino</creatorcontrib><creatorcontrib>Bapat, Vinayak</creatorcontrib><creatorcontrib>Baumbach, Hardy</creatorcontrib><creatorcontrib>Sims, Helen</creatorcontrib><creatorcontrib>Deutsch, Cornelia</creatorcontrib><creatorcontrib>Bramlage, Peter</creatorcontrib><creatorcontrib>Kurucova, Jana</creatorcontrib><creatorcontrib>Thoenes, Martin</creatorcontrib><creatorcontrib>Frank, Derk</creatorcontrib><title>Outcomes after transaortic transcatheter aortic valve implantation: long-term findings from the European ROUTE</title><title>European journal of cardio-thoracic surgery</title><addtitle>Eur J Cardiothorac Surg</addtitle><description>Abstract
OBJECTIVES
There is lack of data regarding the longer-term outcomes of patients undergoing transaortic (TAo) transcatheter aortic valve implantation (TAVI). We aimed to provide a contemporary snapshot of the types and frequencies of events in the year following TAo-TAVI.
METHODS
The Registry of the Utilization of the TAo-TAVI approach using the Edwards SAPIEN Valve (ROUTE) is a multicentre, European, prospective, observational registry of aortic stenosis patients undergoing TAo-TAVI. Patients were grouped according to the composite end point death, myocardial infarction, stroke/transient ischaemic attack, major vascular complications, life-threatening bleeding, acute kidney injury (AKI) and/or cardiovascular rehospitalization.
RESULTS
Two hundred and fifty-three patients with a mean age of 81.5 ± 5.8 years were included, of whom 89 (35.2%) patients met the composite end point (the event group) and 164 (64.8%) patients did not (the event-free group). New York Heart Association (NYHA) class III/IV (85.2% vs 71.8%, P = 0.017), Canadian Cardiovascular Society angina class III/IV (22.6% vs 11.4%; P = 0.021), pulmonary disease (32.6% vs 18.9%; P = 0.015) and renal insufficiency (15.7% vs 3.0%; P < 0.001) were more common in the event group. At 1 year, the most common event was death (19.1%), followed by AKI stage II or III (14.7%). The baseline renal insufficiency was the strongest independent predictor of composite end point achievement [odds ratio (OR) 7.55, 95% confidence interval (CI) 2.33–24.56], followed by NYHA class III/IV (OR 2.316, 95% CI 1.06–5.06) and pulmonary disease (OR 2.91, 95% CI 1.45–5.85). Pulmonary disease was also an independent predictor of 1-year mortality (OR 3.01, 95% CI 1.34–6.75).
CONCLUSIONS
Long-term outcomes after TAo-TAVI appear to be similar to those for TAVI via other non-transfemoral access routes. Awareness of characteristics associated with poorer outcomes may aid patient selection and identification of those requiring closer post-procedural monitoring.
Clinical trial registration number
ClinicalTrials.gov identifier: NCT01991431.</description><issn>1010-7940</issn><issn>1873-734X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><recordid>eNp9kMtLw0AQhxdRbH3cPMve9GDsbiZPb1LqAwoFacFb2Gxma0qSjbubQv3rTU316GmGmW9-DB8hV5zdc5bCBDfS2Ql-7QDgiIx5EoMXQ_B-3PeMMy9OAzYiZ9ZuGGMR-PEpGQGDIAp5OCbNonNS12ipUA4NdUY0VmjjSjn0UrgP3G8Ow62otkjLuq1E44QrdfNAK92svZ6pqSqbomzWliqja9pf0llndIuioW-L1XJ2QU6UqCxeHuo5WT3NltMXb754fp0-zj0JEXceJAmCyLkIhRSoAFTqF7GvMAoT5GkacslZXCRFmkKU8ChkKs8DHjBfJABcwDm5HXJboz87tC6rSyux6p9G3dnM53Hq84Qx6NG7AZVGW2tQZa0pa2F2GWfZ3nD2YzgbDPf49SG5y2ss_uBfpT1wMwC6a_-P-gbxV4fa</recordid><startdate>20190401</startdate><enddate>20190401</enddate><creator>Cocchieri, Riccardo</creator><creator>Petzina, Rainer</creator><creator>Romano, Mauro</creator><creator>Jagielak, Dariusz</creator><creator>Bonaros, Nikolaos</creator><creator>Aiello, Marco</creator><creator>Lapeze, Joel</creator><creator>Laine, Mika</creator><creator>Chocron, Sidney</creator><creator>Muir, Douglas</creator><creator>Eichinger, Walter</creator><creator>Thielmann, Matthias</creator><creator>Labrousse, Louis</creator><creator>Rein, Kjell Arne</creator><creator>Verhoye, Jean-Philippe</creator><creator>Gerosa, Gino</creator><creator>Bapat, Vinayak</creator><creator>Baumbach, Hardy</creator><creator>Sims, Helen</creator><creator>Deutsch, Cornelia</creator><creator>Bramlage, Peter</creator><creator>Kurucova, Jana</creator><creator>Thoenes, Martin</creator><creator>Frank, Derk</creator><general>Oxford University Press</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20190401</creationdate><title>Outcomes after transaortic transcatheter aortic valve implantation: long-term findings from the European ROUTE</title><author>Cocchieri, Riccardo ; Petzina, Rainer ; Romano, Mauro ; Jagielak, Dariusz ; Bonaros, Nikolaos ; Aiello, Marco ; Lapeze, Joel ; Laine, Mika ; Chocron, Sidney ; Muir, Douglas ; Eichinger, Walter ; Thielmann, Matthias ; Labrousse, Louis ; Rein, Kjell Arne ; Verhoye, Jean-Philippe ; Gerosa, Gino ; Bapat, Vinayak ; Baumbach, Hardy ; Sims, Helen ; Deutsch, Cornelia ; Bramlage, Peter ; Kurucova, Jana ; Thoenes, Martin ; Frank, Derk</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c361t-388e3ab1a5acaef33f92d72fe658e19951c107d8d993681650fbb41402a8331a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Cocchieri, Riccardo</creatorcontrib><creatorcontrib>Petzina, Rainer</creatorcontrib><creatorcontrib>Romano, Mauro</creatorcontrib><creatorcontrib>Jagielak, Dariusz</creatorcontrib><creatorcontrib>Bonaros, Nikolaos</creatorcontrib><creatorcontrib>Aiello, Marco</creatorcontrib><creatorcontrib>Lapeze, Joel</creatorcontrib><creatorcontrib>Laine, Mika</creatorcontrib><creatorcontrib>Chocron, Sidney</creatorcontrib><creatorcontrib>Muir, Douglas</creatorcontrib><creatorcontrib>Eichinger, Walter</creatorcontrib><creatorcontrib>Thielmann, Matthias</creatorcontrib><creatorcontrib>Labrousse, Louis</creatorcontrib><creatorcontrib>Rein, Kjell Arne</creatorcontrib><creatorcontrib>Verhoye, Jean-Philippe</creatorcontrib><creatorcontrib>Gerosa, Gino</creatorcontrib><creatorcontrib>Bapat, Vinayak</creatorcontrib><creatorcontrib>Baumbach, Hardy</creatorcontrib><creatorcontrib>Sims, Helen</creatorcontrib><creatorcontrib>Deutsch, Cornelia</creatorcontrib><creatorcontrib>Bramlage, Peter</creatorcontrib><creatorcontrib>Kurucova, Jana</creatorcontrib><creatorcontrib>Thoenes, Martin</creatorcontrib><creatorcontrib>Frank, Derk</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>European journal of cardio-thoracic surgery</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Cocchieri, Riccardo</au><au>Petzina, Rainer</au><au>Romano, Mauro</au><au>Jagielak, Dariusz</au><au>Bonaros, Nikolaos</au><au>Aiello, Marco</au><au>Lapeze, Joel</au><au>Laine, Mika</au><au>Chocron, Sidney</au><au>Muir, Douglas</au><au>Eichinger, Walter</au><au>Thielmann, Matthias</au><au>Labrousse, Louis</au><au>Rein, Kjell Arne</au><au>Verhoye, Jean-Philippe</au><au>Gerosa, Gino</au><au>Bapat, Vinayak</au><au>Baumbach, Hardy</au><au>Sims, Helen</au><au>Deutsch, Cornelia</au><au>Bramlage, Peter</au><au>Kurucova, Jana</au><au>Thoenes, Martin</au><au>Frank, Derk</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Outcomes after transaortic transcatheter aortic valve implantation: long-term findings from the European ROUTE</atitle><jtitle>European journal of cardio-thoracic surgery</jtitle><addtitle>Eur J Cardiothorac Surg</addtitle><date>2019-04-01</date><risdate>2019</risdate><volume>55</volume><issue>4</issue><spage>737</spage><epage>743</epage><pages>737-743</pages><issn>1010-7940</issn><eissn>1873-734X</eissn><abstract>Abstract
OBJECTIVES
There is lack of data regarding the longer-term outcomes of patients undergoing transaortic (TAo) transcatheter aortic valve implantation (TAVI). We aimed to provide a contemporary snapshot of the types and frequencies of events in the year following TAo-TAVI.
METHODS
The Registry of the Utilization of the TAo-TAVI approach using the Edwards SAPIEN Valve (ROUTE) is a multicentre, European, prospective, observational registry of aortic stenosis patients undergoing TAo-TAVI. Patients were grouped according to the composite end point death, myocardial infarction, stroke/transient ischaemic attack, major vascular complications, life-threatening bleeding, acute kidney injury (AKI) and/or cardiovascular rehospitalization.
RESULTS
Two hundred and fifty-three patients with a mean age of 81.5 ± 5.8 years were included, of whom 89 (35.2%) patients met the composite end point (the event group) and 164 (64.8%) patients did not (the event-free group). New York Heart Association (NYHA) class III/IV (85.2% vs 71.8%, P = 0.017), Canadian Cardiovascular Society angina class III/IV (22.6% vs 11.4%; P = 0.021), pulmonary disease (32.6% vs 18.9%; P = 0.015) and renal insufficiency (15.7% vs 3.0%; P < 0.001) were more common in the event group. At 1 year, the most common event was death (19.1%), followed by AKI stage II or III (14.7%). The baseline renal insufficiency was the strongest independent predictor of composite end point achievement [odds ratio (OR) 7.55, 95% confidence interval (CI) 2.33–24.56], followed by NYHA class III/IV (OR 2.316, 95% CI 1.06–5.06) and pulmonary disease (OR 2.91, 95% CI 1.45–5.85). Pulmonary disease was also an independent predictor of 1-year mortality (OR 3.01, 95% CI 1.34–6.75).
CONCLUSIONS
Long-term outcomes after TAo-TAVI appear to be similar to those for TAVI via other non-transfemoral access routes. Awareness of characteristics associated with poorer outcomes may aid patient selection and identification of those requiring closer post-procedural monitoring.
Clinical trial registration number
ClinicalTrials.gov identifier: NCT01991431.</abstract><cop>Germany</cop><pub>Oxford University Press</pub><pmid>30346515</pmid><doi>10.1093/ejcts/ezy333</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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title | Outcomes after transaortic transcatheter aortic valve implantation: long-term findings from the European ROUTE |
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