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
Hauptverfasser: 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
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container_title European journal of cardio-thoracic surgery
container_volume 55
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 
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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 &lt; 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 &lt; 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 ; 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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 &lt; 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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