Transfemoral tricuspid valve replacement and one-year outcomes: the TRISCEND study
Abstract Background and Aims For patients with symptomatic, severe tricuspid regurgitation (TR), early results of transcatheter tricuspid valve (TV) intervention studies have shown significant improvements in functional status and quality of life associated with right-heart reverse remodelling. Long...
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| Veröffentlicht in: | European heart journal 2023-12, Vol.44 (46), p.4862-4873 |
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| creator | Kodali, Susheel Hahn, Rebecca T Makkar, Raj Makar, Moody Davidson, Charles J Puthumana, Jyothy J Zahr, Firas Chadderdon, Scott Fam, Neil Ong, Geraldine Yadav, Pradeep Thourani, Vinod Vannan, Mani A O’Neill, William W Wang, Dee Dee Tchétché, Didier Dumonteil, Nicolas Bonfils, Laurent Lepage, Laurent Smith, Robert Grayburn, Paul A Sharma, Rahul P Haeffele, Christiane Babaliaros, Vasilis Gleason, Patrick T Elmariah, Sammy Inglessis-Azuaje, Ignacio Passeri, Jonathan Herrmann, Howard C Silvestry, Frank E Lim, Scott Fowler, Dale Webb, John G Moss, Robert Modine, Thomas Lafitte, Stephane Latib, Azeem Ho, Edwin Goldberg, Ythan Shah, Pinak Nyman, Charles Rodés-Cabau, Josep Bédard, Elisabeth Brugger, Nicolas Sannino, Anna Mack, Michael J Leon, Martin B Windecker, Stephan |
| description | Abstract
Background and Aims
For patients with symptomatic, severe tricuspid regurgitation (TR), early results of transcatheter tricuspid valve (TV) intervention studies have shown significant improvements in functional status and quality of life associated with right-heart reverse remodelling. Longer-term follow-up is needed to confirm sustained improvements in these outcomes.
Methods
The prospective, single-arm, multicentre TRISCEND study enrolled 176 patients to evaluate the safety and performance of transcatheter TV replacement in patients with ≥moderate, symptomatic TR despite medical therapy. Major adverse events, reduction in TR grade and haemodynamic outcomes by echocardiography, and clinical, functional, and quality-of-life parameters are reported to one year.
Results
Enrolled patients were 71.0% female, mean age 78.7 years, 88.0% ≥ severe TR, and 75.4% New York Heart Association classes III–IV. Tricuspid regurgitation was reduced to ≤mild in 97.6% (P < .001), with increases in stroke volume (10.5 ± 16.8 mL, P < .001) and cardiac output (0.6 ± 1.2 L/min, P < .001). New York Heart Association class I or II was achieved in 93.3% (P < .001), Kansas City Cardiomyopathy Questionnaire score increased by 25.7 points (P < .001), and six-minute walk distance increased by 56.2 m (P < .001). All-cause mortality was 9.1%, and 10.2% of patients were hospitalized for heart failure.
Conclusions
In an elderly, highly comorbid population with ≥moderate TR, patients receiving transfemoral EVOQUE transcatheter TV replacement had sustained TR reduction, significant increases in stroke volume and cardiac output, and high survival and low hospitalization rates with improved clinical, functional, and quality-of-life outcomes to one year. Funded by Edwards Lifesciences, TRISCEND ClinicalTrials.gov number, NCT04221490.
Structured Graphical Abstract
Structured Graphical Abstract
One-year results of transcatheter tricuspid valve replacement in patients with ≥ moderate tricuspid regurgitation. The TRISCEND study demonstrated the following for patients treated with the EVOQUE system: 9.1% all-cause mortality and 10.2% HF hospitalization; significant TR reduction to grade ≤ mild in 97.6% of patients; and marked improvement in functional and quality-of-life outcomes, including a 25.7-point increase in KCCQ, 56.2-m increase in 6MWD, and 93.3% of patients in NYHA class I/II. 6MWD, six-minute walk distance; HFH, heart failure hospitalization; KCCQ, Kansas City Cardiomyopathy Quest |
| doi_str_mv | 10.1093/eurheartj/ehad667 |
| format | Article |
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Background and Aims
For patients with symptomatic, severe tricuspid regurgitation (TR), early results of transcatheter tricuspid valve (TV) intervention studies have shown significant improvements in functional status and quality of life associated with right-heart reverse remodelling. Longer-term follow-up is needed to confirm sustained improvements in these outcomes.
Methods
The prospective, single-arm, multicentre TRISCEND study enrolled 176 patients to evaluate the safety and performance of transcatheter TV replacement in patients with ≥moderate, symptomatic TR despite medical therapy. Major adverse events, reduction in TR grade and haemodynamic outcomes by echocardiography, and clinical, functional, and quality-of-life parameters are reported to one year.
Results
Enrolled patients were 71.0% female, mean age 78.7 years, 88.0% ≥ severe TR, and 75.4% New York Heart Association classes III–IV. Tricuspid regurgitation was reduced to ≤mild in 97.6% (P < .001), with increases in stroke volume (10.5 ± 16.8 mL, P < .001) and cardiac output (0.6 ± 1.2 L/min, P < .001). New York Heart Association class I or II was achieved in 93.3% (P < .001), Kansas City Cardiomyopathy Questionnaire score increased by 25.7 points (P < .001), and six-minute walk distance increased by 56.2 m (P < .001). All-cause mortality was 9.1%, and 10.2% of patients were hospitalized for heart failure.
Conclusions
In an elderly, highly comorbid population with ≥moderate TR, patients receiving transfemoral EVOQUE transcatheter TV replacement had sustained TR reduction, significant increases in stroke volume and cardiac output, and high survival and low hospitalization rates with improved clinical, functional, and quality-of-life outcomes to one year. Funded by Edwards Lifesciences, TRISCEND ClinicalTrials.gov number, NCT04221490.
Structured Graphical Abstract
Structured Graphical Abstract
One-year results of transcatheter tricuspid valve replacement in patients with ≥ moderate tricuspid regurgitation. The TRISCEND study demonstrated the following for patients treated with the EVOQUE system: 9.1% all-cause mortality and 10.2% HF hospitalization; significant TR reduction to grade ≤ mild in 97.6% of patients; and marked improvement in functional and quality-of-life outcomes, including a 25.7-point increase in KCCQ, 56.2-m increase in 6MWD, and 93.3% of patients in NYHA class I/II. 6MWD, six-minute walk distance; HFH, heart failure hospitalization; KCCQ, Kansas City Cardiomyopathy Questionnaire; NYHA, New York Heart Association; TR, tricuspid regurgitation.]]></description><identifier>ISSN: 0195-668X</identifier><identifier>ISSN: 1522-9645</identifier><identifier>EISSN: 1522-9645</identifier><identifier>DOI: 10.1093/eurheartj/ehad667</identifier><identifier>PMID: 37930776</identifier><language>eng</language><publisher>US: Oxford University Press</publisher><subject>Aged ; Cardiac Catheterization - methods ; Female ; Heart Valve Prosthesis Implantation - methods ; Humans ; Male ; Prospective Studies ; Quality of Life ; Severity of Illness Index ; Treatment Outcome ; Tricuspid Valve - surgery ; Tricuspid Valve Insufficiency - epidemiology ; Tricuspid Valve Insufficiency - surgery</subject><ispartof>European heart journal, 2023-12, Vol.44 (46), p.4862-4873</ispartof><rights>The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com 2023</rights><rights>The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c381t-5eae1d04d28eea2b1d9af6971ab84d901bebbe6597efb864985b831a5c9b29eb3</citedby><cites>FETCH-LOGICAL-c381t-5eae1d04d28eea2b1d9af6971ab84d901bebbe6597efb864985b831a5c9b29eb3</cites><orcidid>0000-0002-6613-519X ; 0000-0002-8714-1054 ; 0000-0001-8448-8880 ; 0000-0003-2653-6762 ; 0000-0002-0176-6628</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37930776$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kodali, Susheel</creatorcontrib><creatorcontrib>Hahn, Rebecca T</creatorcontrib><creatorcontrib>Makkar, Raj</creatorcontrib><creatorcontrib>Makar, Moody</creatorcontrib><creatorcontrib>Davidson, Charles J</creatorcontrib><creatorcontrib>Puthumana, Jyothy J</creatorcontrib><creatorcontrib>Zahr, Firas</creatorcontrib><creatorcontrib>Chadderdon, Scott</creatorcontrib><creatorcontrib>Fam, Neil</creatorcontrib><creatorcontrib>Ong, Geraldine</creatorcontrib><creatorcontrib>Yadav, Pradeep</creatorcontrib><creatorcontrib>Thourani, Vinod</creatorcontrib><creatorcontrib>Vannan, Mani A</creatorcontrib><creatorcontrib>O’Neill, William W</creatorcontrib><creatorcontrib>Wang, Dee Dee</creatorcontrib><creatorcontrib>Tchétché, Didier</creatorcontrib><creatorcontrib>Dumonteil, Nicolas</creatorcontrib><creatorcontrib>Bonfils, Laurent</creatorcontrib><creatorcontrib>Lepage, Laurent</creatorcontrib><creatorcontrib>Smith, Robert</creatorcontrib><creatorcontrib>Grayburn, Paul A</creatorcontrib><creatorcontrib>Sharma, Rahul P</creatorcontrib><creatorcontrib>Haeffele, Christiane</creatorcontrib><creatorcontrib>Babaliaros, Vasilis</creatorcontrib><creatorcontrib>Gleason, Patrick T</creatorcontrib><creatorcontrib>Elmariah, Sammy</creatorcontrib><creatorcontrib>Inglessis-Azuaje, Ignacio</creatorcontrib><creatorcontrib>Passeri, Jonathan</creatorcontrib><creatorcontrib>Herrmann, Howard C</creatorcontrib><creatorcontrib>Silvestry, Frank E</creatorcontrib><creatorcontrib>Lim, Scott</creatorcontrib><creatorcontrib>Fowler, Dale</creatorcontrib><creatorcontrib>Webb, John G</creatorcontrib><creatorcontrib>Moss, Robert</creatorcontrib><creatorcontrib>Modine, Thomas</creatorcontrib><creatorcontrib>Lafitte, Stephane</creatorcontrib><creatorcontrib>Latib, Azeem</creatorcontrib><creatorcontrib>Ho, Edwin</creatorcontrib><creatorcontrib>Goldberg, Ythan</creatorcontrib><creatorcontrib>Shah, Pinak</creatorcontrib><creatorcontrib>Nyman, Charles</creatorcontrib><creatorcontrib>Rodés-Cabau, Josep</creatorcontrib><creatorcontrib>Bédard, Elisabeth</creatorcontrib><creatorcontrib>Brugger, Nicolas</creatorcontrib><creatorcontrib>Sannino, Anna</creatorcontrib><creatorcontrib>Mack, Michael J</creatorcontrib><creatorcontrib>Leon, Martin B</creatorcontrib><creatorcontrib>Windecker, Stephan</creatorcontrib><creatorcontrib>the TRISCEND study investigators</creatorcontrib><title>Transfemoral tricuspid valve replacement and one-year outcomes: the TRISCEND study</title><title>European heart journal</title><addtitle>Eur Heart J</addtitle><description><![CDATA[Abstract
Background and Aims
For patients with symptomatic, severe tricuspid regurgitation (TR), early results of transcatheter tricuspid valve (TV) intervention studies have shown significant improvements in functional status and quality of life associated with right-heart reverse remodelling. Longer-term follow-up is needed to confirm sustained improvements in these outcomes.
Methods
The prospective, single-arm, multicentre TRISCEND study enrolled 176 patients to evaluate the safety and performance of transcatheter TV replacement in patients with ≥moderate, symptomatic TR despite medical therapy. Major adverse events, reduction in TR grade and haemodynamic outcomes by echocardiography, and clinical, functional, and quality-of-life parameters are reported to one year.
Results
Enrolled patients were 71.0% female, mean age 78.7 years, 88.0% ≥ severe TR, and 75.4% New York Heart Association classes III–IV. Tricuspid regurgitation was reduced to ≤mild in 97.6% (P < .001), with increases in stroke volume (10.5 ± 16.8 mL, P < .001) and cardiac output (0.6 ± 1.2 L/min, P < .001). New York Heart Association class I or II was achieved in 93.3% (P < .001), Kansas City Cardiomyopathy Questionnaire score increased by 25.7 points (P < .001), and six-minute walk distance increased by 56.2 m (P < .001). All-cause mortality was 9.1%, and 10.2% of patients were hospitalized for heart failure.
Conclusions
In an elderly, highly comorbid population with ≥moderate TR, patients receiving transfemoral EVOQUE transcatheter TV replacement had sustained TR reduction, significant increases in stroke volume and cardiac output, and high survival and low hospitalization rates with improved clinical, functional, and quality-of-life outcomes to one year. Funded by Edwards Lifesciences, TRISCEND ClinicalTrials.gov number, NCT04221490.
Structured Graphical Abstract
Structured Graphical Abstract
One-year results of transcatheter tricuspid valve replacement in patients with ≥ moderate tricuspid regurgitation. The TRISCEND study demonstrated the following for patients treated with the EVOQUE system: 9.1% all-cause mortality and 10.2% HF hospitalization; significant TR reduction to grade ≤ mild in 97.6% of patients; and marked improvement in functional and quality-of-life outcomes, including a 25.7-point increase in KCCQ, 56.2-m increase in 6MWD, and 93.3% of patients in NYHA class I/II. 6MWD, six-minute walk distance; HFH, heart failure hospitalization; KCCQ, Kansas City Cardiomyopathy Questionnaire; NYHA, New York Heart Association; TR, tricuspid regurgitation.]]></description><subject>Aged</subject><subject>Cardiac Catheterization - methods</subject><subject>Female</subject><subject>Heart Valve Prosthesis Implantation - methods</subject><subject>Humans</subject><subject>Male</subject><subject>Prospective Studies</subject><subject>Quality of Life</subject><subject>Severity of Illness Index</subject><subject>Treatment Outcome</subject><subject>Tricuspid Valve - surgery</subject><subject>Tricuspid Valve Insufficiency - epidemiology</subject><subject>Tricuspid Valve Insufficiency - surgery</subject><issn>0195-668X</issn><issn>1522-9645</issn><issn>1522-9645</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkEtLAzEURoMotlZ_gBvJ0oVjk3lkEndSqxaKQq3gbkgmd2jLzGTMo9B_75RW167u5nznwkHompJ7SkQyhmBXIK3fjGElNWP5CRrSLI4jwdLsFA0JFVnEGP8aoAvnNoQQzig7R4MkFwnJczZEi6WVraugMVbW2Nt1GVy31ngr6y1gC10tS2ig9Vi2GpsWol3_EZvgS9OAe8B-BXi5mH1Mpm9P2Pmgd5forJK1g6vjHaHP5-ly8hrN319mk8d5VCac-igDCVSTVMccQMaKaiErJnIqFU-1IFSBUsAykUOlOEsFzxRPqMxKoWIBKhmh24O3s-Y7gPNFs3Yl1LVswQRXxJzv15lgPUoPaGmNcxaqorPrRtpdQUmxT1n8pSyOKfvNzVEfVAP6b_HbrgfuDoAJ3T98PxILhCk</recordid><startdate>20231207</startdate><enddate>20231207</enddate><creator>Kodali, Susheel</creator><creator>Hahn, Rebecca T</creator><creator>Makkar, Raj</creator><creator>Makar, Moody</creator><creator>Davidson, Charles J</creator><creator>Puthumana, Jyothy J</creator><creator>Zahr, Firas</creator><creator>Chadderdon, Scott</creator><creator>Fam, Neil</creator><creator>Ong, Geraldine</creator><creator>Yadav, Pradeep</creator><creator>Thourani, Vinod</creator><creator>Vannan, Mani A</creator><creator>O’Neill, William W</creator><creator>Wang, Dee Dee</creator><creator>Tchétché, Didier</creator><creator>Dumonteil, Nicolas</creator><creator>Bonfils, Laurent</creator><creator>Lepage, Laurent</creator><creator>Smith, Robert</creator><creator>Grayburn, Paul A</creator><creator>Sharma, Rahul P</creator><creator>Haeffele, Christiane</creator><creator>Babaliaros, Vasilis</creator><creator>Gleason, Patrick T</creator><creator>Elmariah, Sammy</creator><creator>Inglessis-Azuaje, Ignacio</creator><creator>Passeri, Jonathan</creator><creator>Herrmann, Howard C</creator><creator>Silvestry, Frank E</creator><creator>Lim, Scott</creator><creator>Fowler, Dale</creator><creator>Webb, John G</creator><creator>Moss, Robert</creator><creator>Modine, Thomas</creator><creator>Lafitte, Stephane</creator><creator>Latib, Azeem</creator><creator>Ho, Edwin</creator><creator>Goldberg, Ythan</creator><creator>Shah, Pinak</creator><creator>Nyman, Charles</creator><creator>Rodés-Cabau, Josep</creator><creator>Bédard, Elisabeth</creator><creator>Brugger, Nicolas</creator><creator>Sannino, Anna</creator><creator>Mack, Michael J</creator><creator>Leon, Martin B</creator><creator>Windecker, Stephan</creator><general>Oxford University Press</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><orcidid>https://orcid.org/0000-0002-6613-519X</orcidid><orcidid>https://orcid.org/0000-0002-8714-1054</orcidid><orcidid>https://orcid.org/0000-0001-8448-8880</orcidid><orcidid>https://orcid.org/0000-0003-2653-6762</orcidid><orcidid>https://orcid.org/0000-0002-0176-6628</orcidid></search><sort><creationdate>20231207</creationdate><title>Transfemoral tricuspid valve replacement and one-year outcomes: the TRISCEND study</title><author>Kodali, Susheel ; Hahn, Rebecca T ; Makkar, Raj ; Makar, Moody ; Davidson, Charles J ; Puthumana, Jyothy J ; Zahr, Firas ; Chadderdon, Scott ; Fam, Neil ; Ong, Geraldine ; Yadav, Pradeep ; Thourani, Vinod ; Vannan, Mani A ; O’Neill, William W ; Wang, Dee Dee ; Tchétché, Didier ; Dumonteil, Nicolas ; Bonfils, Laurent ; Lepage, Laurent ; Smith, Robert ; Grayburn, Paul A ; Sharma, Rahul P ; Haeffele, Christiane ; Babaliaros, Vasilis ; Gleason, Patrick T ; Elmariah, Sammy ; Inglessis-Azuaje, Ignacio ; Passeri, Jonathan ; Herrmann, Howard C ; Silvestry, Frank E ; Lim, Scott ; Fowler, Dale ; Webb, John G ; Moss, Robert ; Modine, Thomas ; Lafitte, Stephane ; Latib, Azeem ; Ho, Edwin ; Goldberg, Ythan ; Shah, Pinak ; Nyman, Charles ; Rodés-Cabau, Josep ; Bédard, Elisabeth ; Brugger, Nicolas ; Sannino, Anna ; Mack, Michael J ; Leon, Martin B ; Windecker, Stephan</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c381t-5eae1d04d28eea2b1d9af6971ab84d901bebbe6597efb864985b831a5c9b29eb3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Aged</topic><topic>Cardiac Catheterization - methods</topic><topic>Female</topic><topic>Heart Valve Prosthesis Implantation - methods</topic><topic>Humans</topic><topic>Male</topic><topic>Prospective Studies</topic><topic>Quality of Life</topic><topic>Severity of Illness Index</topic><topic>Treatment Outcome</topic><topic>Tricuspid Valve - surgery</topic><topic>Tricuspid Valve Insufficiency - epidemiology</topic><topic>Tricuspid Valve Insufficiency - surgery</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kodali, Susheel</creatorcontrib><creatorcontrib>Hahn, Rebecca T</creatorcontrib><creatorcontrib>Makkar, Raj</creatorcontrib><creatorcontrib>Makar, Moody</creatorcontrib><creatorcontrib>Davidson, Charles J</creatorcontrib><creatorcontrib>Puthumana, Jyothy J</creatorcontrib><creatorcontrib>Zahr, Firas</creatorcontrib><creatorcontrib>Chadderdon, Scott</creatorcontrib><creatorcontrib>Fam, Neil</creatorcontrib><creatorcontrib>Ong, Geraldine</creatorcontrib><creatorcontrib>Yadav, Pradeep</creatorcontrib><creatorcontrib>Thourani, Vinod</creatorcontrib><creatorcontrib>Vannan, Mani A</creatorcontrib><creatorcontrib>O’Neill, William W</creatorcontrib><creatorcontrib>Wang, Dee Dee</creatorcontrib><creatorcontrib>Tchétché, Didier</creatorcontrib><creatorcontrib>Dumonteil, Nicolas</creatorcontrib><creatorcontrib>Bonfils, Laurent</creatorcontrib><creatorcontrib>Lepage, Laurent</creatorcontrib><creatorcontrib>Smith, Robert</creatorcontrib><creatorcontrib>Grayburn, Paul A</creatorcontrib><creatorcontrib>Sharma, Rahul P</creatorcontrib><creatorcontrib>Haeffele, Christiane</creatorcontrib><creatorcontrib>Babaliaros, Vasilis</creatorcontrib><creatorcontrib>Gleason, Patrick T</creatorcontrib><creatorcontrib>Elmariah, Sammy</creatorcontrib><creatorcontrib>Inglessis-Azuaje, Ignacio</creatorcontrib><creatorcontrib>Passeri, Jonathan</creatorcontrib><creatorcontrib>Herrmann, Howard C</creatorcontrib><creatorcontrib>Silvestry, Frank E</creatorcontrib><creatorcontrib>Lim, Scott</creatorcontrib><creatorcontrib>Fowler, Dale</creatorcontrib><creatorcontrib>Webb, John G</creatorcontrib><creatorcontrib>Moss, Robert</creatorcontrib><creatorcontrib>Modine, Thomas</creatorcontrib><creatorcontrib>Lafitte, Stephane</creatorcontrib><creatorcontrib>Latib, Azeem</creatorcontrib><creatorcontrib>Ho, Edwin</creatorcontrib><creatorcontrib>Goldberg, Ythan</creatorcontrib><creatorcontrib>Shah, Pinak</creatorcontrib><creatorcontrib>Nyman, Charles</creatorcontrib><creatorcontrib>Rodés-Cabau, Josep</creatorcontrib><creatorcontrib>Bédard, Elisabeth</creatorcontrib><creatorcontrib>Brugger, Nicolas</creatorcontrib><creatorcontrib>Sannino, Anna</creatorcontrib><creatorcontrib>Mack, Michael J</creatorcontrib><creatorcontrib>Leon, Martin B</creatorcontrib><creatorcontrib>Windecker, Stephan</creatorcontrib><creatorcontrib>the TRISCEND study investigators</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>European heart journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kodali, Susheel</au><au>Hahn, Rebecca T</au><au>Makkar, Raj</au><au>Makar, Moody</au><au>Davidson, Charles J</au><au>Puthumana, Jyothy J</au><au>Zahr, Firas</au><au>Chadderdon, Scott</au><au>Fam, Neil</au><au>Ong, Geraldine</au><au>Yadav, Pradeep</au><au>Thourani, Vinod</au><au>Vannan, Mani A</au><au>O’Neill, William W</au><au>Wang, Dee Dee</au><au>Tchétché, Didier</au><au>Dumonteil, Nicolas</au><au>Bonfils, Laurent</au><au>Lepage, Laurent</au><au>Smith, Robert</au><au>Grayburn, Paul A</au><au>Sharma, Rahul P</au><au>Haeffele, Christiane</au><au>Babaliaros, Vasilis</au><au>Gleason, Patrick T</au><au>Elmariah, Sammy</au><au>Inglessis-Azuaje, Ignacio</au><au>Passeri, Jonathan</au><au>Herrmann, Howard C</au><au>Silvestry, Frank E</au><au>Lim, Scott</au><au>Fowler, Dale</au><au>Webb, John G</au><au>Moss, Robert</au><au>Modine, Thomas</au><au>Lafitte, Stephane</au><au>Latib, Azeem</au><au>Ho, Edwin</au><au>Goldberg, Ythan</au><au>Shah, Pinak</au><au>Nyman, Charles</au><au>Rodés-Cabau, Josep</au><au>Bédard, Elisabeth</au><au>Brugger, Nicolas</au><au>Sannino, Anna</au><au>Mack, Michael J</au><au>Leon, Martin B</au><au>Windecker, Stephan</au><aucorp>the TRISCEND study investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Transfemoral tricuspid valve replacement and one-year outcomes: the TRISCEND study</atitle><jtitle>European heart journal</jtitle><addtitle>Eur Heart J</addtitle><date>2023-12-07</date><risdate>2023</risdate><volume>44</volume><issue>46</issue><spage>4862</spage><epage>4873</epage><pages>4862-4873</pages><issn>0195-668X</issn><issn>1522-9645</issn><eissn>1522-9645</eissn><abstract><![CDATA[Abstract
Background and Aims
For patients with symptomatic, severe tricuspid regurgitation (TR), early results of transcatheter tricuspid valve (TV) intervention studies have shown significant improvements in functional status and quality of life associated with right-heart reverse remodelling. Longer-term follow-up is needed to confirm sustained improvements in these outcomes.
Methods
The prospective, single-arm, multicentre TRISCEND study enrolled 176 patients to evaluate the safety and performance of transcatheter TV replacement in patients with ≥moderate, symptomatic TR despite medical therapy. Major adverse events, reduction in TR grade and haemodynamic outcomes by echocardiography, and clinical, functional, and quality-of-life parameters are reported to one year.
Results
Enrolled patients were 71.0% female, mean age 78.7 years, 88.0% ≥ severe TR, and 75.4% New York Heart Association classes III–IV. Tricuspid regurgitation was reduced to ≤mild in 97.6% (P < .001), with increases in stroke volume (10.5 ± 16.8 mL, P < .001) and cardiac output (0.6 ± 1.2 L/min, P < .001). New York Heart Association class I or II was achieved in 93.3% (P < .001), Kansas City Cardiomyopathy Questionnaire score increased by 25.7 points (P < .001), and six-minute walk distance increased by 56.2 m (P < .001). All-cause mortality was 9.1%, and 10.2% of patients were hospitalized for heart failure.
Conclusions
In an elderly, highly comorbid population with ≥moderate TR, patients receiving transfemoral EVOQUE transcatheter TV replacement had sustained TR reduction, significant increases in stroke volume and cardiac output, and high survival and low hospitalization rates with improved clinical, functional, and quality-of-life outcomes to one year. Funded by Edwards Lifesciences, TRISCEND ClinicalTrials.gov number, NCT04221490.
Structured Graphical Abstract
Structured Graphical Abstract
One-year results of transcatheter tricuspid valve replacement in patients with ≥ moderate tricuspid regurgitation. The TRISCEND study demonstrated the following for patients treated with the EVOQUE system: 9.1% all-cause mortality and 10.2% HF hospitalization; significant TR reduction to grade ≤ mild in 97.6% of patients; and marked improvement in functional and quality-of-life outcomes, including a 25.7-point increase in KCCQ, 56.2-m increase in 6MWD, and 93.3% of patients in NYHA class I/II. 6MWD, six-minute walk distance; HFH, heart failure hospitalization; KCCQ, Kansas City Cardiomyopathy Questionnaire; NYHA, New York Heart Association; TR, tricuspid regurgitation.]]></abstract><cop>US</cop><pub>Oxford University Press</pub><pmid>37930776</pmid><doi>10.1093/eurheartj/ehad667</doi><tpages>12</tpages><orcidid>https://orcid.org/0000-0002-6613-519X</orcidid><orcidid>https://orcid.org/0000-0002-8714-1054</orcidid><orcidid>https://orcid.org/0000-0001-8448-8880</orcidid><orcidid>https://orcid.org/0000-0003-2653-6762</orcidid><orcidid>https://orcid.org/0000-0002-0176-6628</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0195-668X |
| ispartof | European heart journal, 2023-12, Vol.44 (46), p.4862-4873 |
| issn | 0195-668X 1522-9645 1522-9645 |
| language | eng |
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| source | Oxford University Press Journals All Titles (1996-Current); MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
| subjects | Aged Cardiac Catheterization - methods Female Heart Valve Prosthesis Implantation - methods Humans Male Prospective Studies Quality of Life Severity of Illness Index Treatment Outcome Tricuspid Valve - surgery Tricuspid Valve Insufficiency - epidemiology Tricuspid Valve Insufficiency - surgery |
| title | Transfemoral tricuspid valve replacement and one-year outcomes: the TRISCEND study |
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