Prospective Evaluation of Transseptal TMVR for Failed Surgical Bioprostheses: MITRAL Trial Valve-in-Valve Arm 1-Year Outcomes
The aim of this study was to assess 1-year clinical outcomes among high-risk patients with failed surgical mitral bioprostheses who underwent transseptal mitral valve-in-valve (MViV) with the SAPIEN 3 aortic transcatheter heart valve (THV) in the MITRAL (Mitral Implantation of Transcatheter Valves)...
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| Veröffentlicht in: | JACC. Cardiovascular interventions 2021-04, Vol.14 (8), p.859-872 |
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| creator | Guerrero, Mayra Pursnani, Amit Narang, Akhil Salinger, Michael Wang, Dee Dee Eleid, Mackram Kodali, Susheel K George, Isaac Satler, Lowell Waksman, Ron Meduri, Christopher U Rajagopal, Vivek Inglessis, Ignacio Palacios, Igor Reisman, Mark Eng, Marvin H Russell, Hyde M Pershad, Ashish Fang, Kenith Kar, Saibal Makkar, Rajj Saucedo, Jorge Pearson, Paul Bokhary, Ujala Kaptzan, Tatiana Lewis, Brad Tommaso, Carl Krause, Philip Thaden, Jeremy Oh, Jae Lang, Roberto M Hahn, Rebecca T Leon, Martin B O'Neill, William W Feldman, Ted Rihal, Charanjit |
| description | The aim of this study was to assess 1-year clinical outcomes among high-risk patients with failed surgical mitral bioprostheses who underwent transseptal mitral valve-in-valve (MViV) with the SAPIEN 3 aortic transcatheter heart valve (THV) in the MITRAL (Mitral Implantation of Transcatheter Valves) trial.
The MITRAL trial is the first prospective study evaluating transseptal MViV with the SAPIEN 3 aortic THV in high-risk patients with failed surgical mitral bioprostheses.
High-risk patients with symptomatic moderate to severe or severe mitral regurgitation (MR) or severe mitral stenosis due to failed surgical mitral bioprostheses were prospectively enrolled. The primary safety endpoint was technical success. The primary THV performance endpoint was absence of MR grade ≥2+ or mean mitral valve gradient ≥10 mm Hg (30 days and 1 year). Secondary endpoints included procedural success and all-cause mortality (30 days and 1 year).
Thirty patients were enrolled between July 2016 and October 2017 (median age 77.5 years [interquartile range (IQR): 70.3 to 82.8 years], 63.3% women, median Society of Thoracic Surgeons score 9.4% [IQR: 5.8% to 12.0%], 80% in New York Heart Association functional class III or IV). The technical success rate was 100%. The primary performance endpoint in survivors was achieved in 96.6% (28 of 29) at 30 days and 82.8% (24 of 29) at 1 year. Thirty-day all-cause mortality was 3.3% and was unchanged at 1 year. The only death was due to airway obstruction after swallowing several pills simultaneously 29 days post-MViV. At 1-year follow-up, 89.3% of patients were in New York Heart Association functional class I or II, the median mean mitral valve gradient was 6.6 mm Hg (interquartile range: 5.5 to 8.9 mm Hg), and all patients had MR grade ≤1+.
Transseptal MViV in high-risk patients was associated with 100% technical success, low procedural complication rates, and very low mortality at 1 year. The vast majority of patients experienced significant symptom alleviation, and THV performance remained stable at 1 year. |
| doi_str_mv | 10.1016/j.jcin.2021.02.027 |
| format | Article |
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The MITRAL trial is the first prospective study evaluating transseptal MViV with the SAPIEN 3 aortic THV in high-risk patients with failed surgical mitral bioprostheses.
High-risk patients with symptomatic moderate to severe or severe mitral regurgitation (MR) or severe mitral stenosis due to failed surgical mitral bioprostheses were prospectively enrolled. The primary safety endpoint was technical success. The primary THV performance endpoint was absence of MR grade ≥2+ or mean mitral valve gradient ≥10 mm Hg (30 days and 1 year). Secondary endpoints included procedural success and all-cause mortality (30 days and 1 year).
Thirty patients were enrolled between July 2016 and October 2017 (median age 77.5 years [interquartile range (IQR): 70.3 to 82.8 years], 63.3% women, median Society of Thoracic Surgeons score 9.4% [IQR: 5.8% to 12.0%], 80% in New York Heart Association functional class III or IV). The technical success rate was 100%. The primary performance endpoint in survivors was achieved in 96.6% (28 of 29) at 30 days and 82.8% (24 of 29) at 1 year. Thirty-day all-cause mortality was 3.3% and was unchanged at 1 year. The only death was due to airway obstruction after swallowing several pills simultaneously 29 days post-MViV. At 1-year follow-up, 89.3% of patients were in New York Heart Association functional class I or II, the median mean mitral valve gradient was 6.6 mm Hg (interquartile range: 5.5 to 8.9 mm Hg), and all patients had MR grade ≤1+.
Transseptal MViV in high-risk patients was associated with 100% technical success, low procedural complication rates, and very low mortality at 1 year. The vast majority of patients experienced significant symptom alleviation, and THV performance remained stable at 1 year.</description><identifier>EISSN: 1876-7605</identifier><identifier>DOI: 10.1016/j.jcin.2021.02.027</identifier><identifier>PMID: 33888231</identifier><language>eng</language><publisher>United States</publisher><subject>Aged ; Aged, 80 and over ; Bioprosthesis ; Cardiac Catheterization - adverse effects ; Female ; Heart Valve Prosthesis ; Heart Valve Prosthesis Implantation - adverse effects ; Humans ; Male ; Mitral Valve Annuloplasty ; Prospective Studies ; Prosthesis Design ; Treatment Outcome</subject><ispartof>JACC. Cardiovascular interventions, 2021-04, Vol.14 (8), p.859-872</ispartof><rights>Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></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/33888231$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Guerrero, Mayra</creatorcontrib><creatorcontrib>Pursnani, Amit</creatorcontrib><creatorcontrib>Narang, Akhil</creatorcontrib><creatorcontrib>Salinger, Michael</creatorcontrib><creatorcontrib>Wang, Dee Dee</creatorcontrib><creatorcontrib>Eleid, Mackram</creatorcontrib><creatorcontrib>Kodali, Susheel K</creatorcontrib><creatorcontrib>George, Isaac</creatorcontrib><creatorcontrib>Satler, Lowell</creatorcontrib><creatorcontrib>Waksman, Ron</creatorcontrib><creatorcontrib>Meduri, Christopher U</creatorcontrib><creatorcontrib>Rajagopal, Vivek</creatorcontrib><creatorcontrib>Inglessis, Ignacio</creatorcontrib><creatorcontrib>Palacios, Igor</creatorcontrib><creatorcontrib>Reisman, Mark</creatorcontrib><creatorcontrib>Eng, Marvin H</creatorcontrib><creatorcontrib>Russell, Hyde M</creatorcontrib><creatorcontrib>Pershad, Ashish</creatorcontrib><creatorcontrib>Fang, Kenith</creatorcontrib><creatorcontrib>Kar, Saibal</creatorcontrib><creatorcontrib>Makkar, Rajj</creatorcontrib><creatorcontrib>Saucedo, Jorge</creatorcontrib><creatorcontrib>Pearson, Paul</creatorcontrib><creatorcontrib>Bokhary, Ujala</creatorcontrib><creatorcontrib>Kaptzan, Tatiana</creatorcontrib><creatorcontrib>Lewis, Brad</creatorcontrib><creatorcontrib>Tommaso, Carl</creatorcontrib><creatorcontrib>Krause, Philip</creatorcontrib><creatorcontrib>Thaden, Jeremy</creatorcontrib><creatorcontrib>Oh, Jae</creatorcontrib><creatorcontrib>Lang, Roberto M</creatorcontrib><creatorcontrib>Hahn, Rebecca T</creatorcontrib><creatorcontrib>Leon, Martin B</creatorcontrib><creatorcontrib>O'Neill, William W</creatorcontrib><creatorcontrib>Feldman, Ted</creatorcontrib><creatorcontrib>Rihal, Charanjit</creatorcontrib><title>Prospective Evaluation of Transseptal TMVR for Failed Surgical Bioprostheses: MITRAL Trial Valve-in-Valve Arm 1-Year Outcomes</title><title>JACC. Cardiovascular interventions</title><addtitle>JACC Cardiovasc Interv</addtitle><description>The aim of this study was to assess 1-year clinical outcomes among high-risk patients with failed surgical mitral bioprostheses who underwent transseptal mitral valve-in-valve (MViV) with the SAPIEN 3 aortic transcatheter heart valve (THV) in the MITRAL (Mitral Implantation of Transcatheter Valves) trial.
The MITRAL trial is the first prospective study evaluating transseptal MViV with the SAPIEN 3 aortic THV in high-risk patients with failed surgical mitral bioprostheses.
High-risk patients with symptomatic moderate to severe or severe mitral regurgitation (MR) or severe mitral stenosis due to failed surgical mitral bioprostheses were prospectively enrolled. The primary safety endpoint was technical success. The primary THV performance endpoint was absence of MR grade ≥2+ or mean mitral valve gradient ≥10 mm Hg (30 days and 1 year). Secondary endpoints included procedural success and all-cause mortality (30 days and 1 year).
Thirty patients were enrolled between July 2016 and October 2017 (median age 77.5 years [interquartile range (IQR): 70.3 to 82.8 years], 63.3% women, median Society of Thoracic Surgeons score 9.4% [IQR: 5.8% to 12.0%], 80% in New York Heart Association functional class III or IV). The technical success rate was 100%. The primary performance endpoint in survivors was achieved in 96.6% (28 of 29) at 30 days and 82.8% (24 of 29) at 1 year. Thirty-day all-cause mortality was 3.3% and was unchanged at 1 year. The only death was due to airway obstruction after swallowing several pills simultaneously 29 days post-MViV. At 1-year follow-up, 89.3% of patients were in New York Heart Association functional class I or II, the median mean mitral valve gradient was 6.6 mm Hg (interquartile range: 5.5 to 8.9 mm Hg), and all patients had MR grade ≤1+.
Transseptal MViV in high-risk patients was associated with 100% technical success, low procedural complication rates, and very low mortality at 1 year. The vast majority of patients experienced significant symptom alleviation, and THV performance remained stable at 1 year.</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Bioprosthesis</subject><subject>Cardiac Catheterization - adverse effects</subject><subject>Female</subject><subject>Heart Valve Prosthesis</subject><subject>Heart Valve Prosthesis Implantation - adverse effects</subject><subject>Humans</subject><subject>Male</subject><subject>Mitral Valve Annuloplasty</subject><subject>Prospective Studies</subject><subject>Prosthesis Design</subject><subject>Treatment Outcome</subject><issn>1876-7605</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo1UMtKAzEUDYLYWv0BF5KlmxmTzCMZd7W0Wmip1LHgaojJjabMy8lMwYX_btAKB-6B8-BwEbqiJKSEprf7cK9sHTLCaEiYBz9BYyp4GvCUJCN07tyekJRknJ2hURQJIVhEx-j7qWtcC6q3B8DzgywH2dumxo3BeSdr56DtZYnz9W6LTdPhhbQlaPw8dO9WeeHeNq1v6D_AgbvD62W-na581HptJ8sDBLYOfgmedhWmwSvIDm-GXjUVuAt0amTp4PJ4J-hlMc9nj8Fq87CcTVdByyjtg1SrTPDEUK20JpRyo3nCEwnMU85lQlSiScR0JEwGMaUgDItBckN0LImMJujmr9dv_RzA9UVlnYKylDU0gytYQkUSpzzj3np9tA5vFeii7Wwlu6_i_2XRD7RcbZI</recordid><startdate>20210426</startdate><enddate>20210426</enddate><creator>Guerrero, Mayra</creator><creator>Pursnani, Amit</creator><creator>Narang, Akhil</creator><creator>Salinger, Michael</creator><creator>Wang, Dee Dee</creator><creator>Eleid, Mackram</creator><creator>Kodali, Susheel K</creator><creator>George, Isaac</creator><creator>Satler, Lowell</creator><creator>Waksman, Ron</creator><creator>Meduri, Christopher U</creator><creator>Rajagopal, Vivek</creator><creator>Inglessis, Ignacio</creator><creator>Palacios, Igor</creator><creator>Reisman, Mark</creator><creator>Eng, Marvin H</creator><creator>Russell, Hyde M</creator><creator>Pershad, Ashish</creator><creator>Fang, Kenith</creator><creator>Kar, Saibal</creator><creator>Makkar, Rajj</creator><creator>Saucedo, Jorge</creator><creator>Pearson, Paul</creator><creator>Bokhary, Ujala</creator><creator>Kaptzan, Tatiana</creator><creator>Lewis, Brad</creator><creator>Tommaso, Carl</creator><creator>Krause, Philip</creator><creator>Thaden, Jeremy</creator><creator>Oh, Jae</creator><creator>Lang, Roberto M</creator><creator>Hahn, Rebecca T</creator><creator>Leon, Martin B</creator><creator>O'Neill, William W</creator><creator>Feldman, Ted</creator><creator>Rihal, Charanjit</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>20210426</creationdate><title>Prospective Evaluation of Transseptal TMVR for Failed Surgical Bioprostheses: MITRAL Trial Valve-in-Valve Arm 1-Year Outcomes</title><author>Guerrero, Mayra ; Pursnani, Amit ; Narang, Akhil ; Salinger, Michael ; Wang, Dee Dee ; Eleid, Mackram ; Kodali, Susheel K ; George, Isaac ; Satler, Lowell ; Waksman, Ron ; Meduri, Christopher U ; Rajagopal, Vivek ; Inglessis, Ignacio ; Palacios, Igor ; Reisman, Mark ; Eng, Marvin H ; Russell, Hyde M ; Pershad, Ashish ; Fang, Kenith ; Kar, Saibal ; Makkar, Rajj ; Saucedo, Jorge ; Pearson, Paul ; Bokhary, Ujala ; Kaptzan, Tatiana ; Lewis, Brad ; Tommaso, Carl ; Krause, Philip ; Thaden, Jeremy ; Oh, Jae ; Lang, Roberto M ; Hahn, Rebecca T ; Leon, Martin B ; O'Neill, William W ; Feldman, Ted ; Rihal, Charanjit</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p211t-6dc9875f1dcdd0117fd7575ae217f77a50c5d032d38f9e411e8f24ea7f0d4a0a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Bioprosthesis</topic><topic>Cardiac Catheterization - adverse effects</topic><topic>Female</topic><topic>Heart Valve Prosthesis</topic><topic>Heart Valve Prosthesis Implantation - adverse effects</topic><topic>Humans</topic><topic>Male</topic><topic>Mitral Valve Annuloplasty</topic><topic>Prospective Studies</topic><topic>Prosthesis Design</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Guerrero, Mayra</creatorcontrib><creatorcontrib>Pursnani, Amit</creatorcontrib><creatorcontrib>Narang, Akhil</creatorcontrib><creatorcontrib>Salinger, Michael</creatorcontrib><creatorcontrib>Wang, Dee Dee</creatorcontrib><creatorcontrib>Eleid, Mackram</creatorcontrib><creatorcontrib>Kodali, Susheel K</creatorcontrib><creatorcontrib>George, Isaac</creatorcontrib><creatorcontrib>Satler, Lowell</creatorcontrib><creatorcontrib>Waksman, Ron</creatorcontrib><creatorcontrib>Meduri, Christopher U</creatorcontrib><creatorcontrib>Rajagopal, Vivek</creatorcontrib><creatorcontrib>Inglessis, Ignacio</creatorcontrib><creatorcontrib>Palacios, Igor</creatorcontrib><creatorcontrib>Reisman, Mark</creatorcontrib><creatorcontrib>Eng, Marvin H</creatorcontrib><creatorcontrib>Russell, Hyde M</creatorcontrib><creatorcontrib>Pershad, Ashish</creatorcontrib><creatorcontrib>Fang, Kenith</creatorcontrib><creatorcontrib>Kar, Saibal</creatorcontrib><creatorcontrib>Makkar, Rajj</creatorcontrib><creatorcontrib>Saucedo, Jorge</creatorcontrib><creatorcontrib>Pearson, Paul</creatorcontrib><creatorcontrib>Bokhary, Ujala</creatorcontrib><creatorcontrib>Kaptzan, Tatiana</creatorcontrib><creatorcontrib>Lewis, Brad</creatorcontrib><creatorcontrib>Tommaso, Carl</creatorcontrib><creatorcontrib>Krause, Philip</creatorcontrib><creatorcontrib>Thaden, Jeremy</creatorcontrib><creatorcontrib>Oh, Jae</creatorcontrib><creatorcontrib>Lang, Roberto M</creatorcontrib><creatorcontrib>Hahn, Rebecca T</creatorcontrib><creatorcontrib>Leon, Martin B</creatorcontrib><creatorcontrib>O'Neill, William W</creatorcontrib><creatorcontrib>Feldman, Ted</creatorcontrib><creatorcontrib>Rihal, Charanjit</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>MEDLINE - Academic</collection><jtitle>JACC. Cardiovascular interventions</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Guerrero, Mayra</au><au>Pursnani, Amit</au><au>Narang, Akhil</au><au>Salinger, Michael</au><au>Wang, Dee Dee</au><au>Eleid, Mackram</au><au>Kodali, Susheel K</au><au>George, Isaac</au><au>Satler, Lowell</au><au>Waksman, Ron</au><au>Meduri, Christopher U</au><au>Rajagopal, Vivek</au><au>Inglessis, Ignacio</au><au>Palacios, Igor</au><au>Reisman, Mark</au><au>Eng, Marvin H</au><au>Russell, Hyde M</au><au>Pershad, Ashish</au><au>Fang, Kenith</au><au>Kar, Saibal</au><au>Makkar, Rajj</au><au>Saucedo, Jorge</au><au>Pearson, Paul</au><au>Bokhary, Ujala</au><au>Kaptzan, Tatiana</au><au>Lewis, Brad</au><au>Tommaso, Carl</au><au>Krause, Philip</au><au>Thaden, Jeremy</au><au>Oh, Jae</au><au>Lang, Roberto M</au><au>Hahn, Rebecca T</au><au>Leon, Martin B</au><au>O'Neill, William W</au><au>Feldman, Ted</au><au>Rihal, Charanjit</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Prospective Evaluation of Transseptal TMVR for Failed Surgical Bioprostheses: MITRAL Trial Valve-in-Valve Arm 1-Year Outcomes</atitle><jtitle>JACC. Cardiovascular interventions</jtitle><addtitle>JACC Cardiovasc Interv</addtitle><date>2021-04-26</date><risdate>2021</risdate><volume>14</volume><issue>8</issue><spage>859</spage><epage>872</epage><pages>859-872</pages><eissn>1876-7605</eissn><abstract>The aim of this study was to assess 1-year clinical outcomes among high-risk patients with failed surgical mitral bioprostheses who underwent transseptal mitral valve-in-valve (MViV) with the SAPIEN 3 aortic transcatheter heart valve (THV) in the MITRAL (Mitral Implantation of Transcatheter Valves) trial.
The MITRAL trial is the first prospective study evaluating transseptal MViV with the SAPIEN 3 aortic THV in high-risk patients with failed surgical mitral bioprostheses.
High-risk patients with symptomatic moderate to severe or severe mitral regurgitation (MR) or severe mitral stenosis due to failed surgical mitral bioprostheses were prospectively enrolled. The primary safety endpoint was technical success. The primary THV performance endpoint was absence of MR grade ≥2+ or mean mitral valve gradient ≥10 mm Hg (30 days and 1 year). Secondary endpoints included procedural success and all-cause mortality (30 days and 1 year).
Thirty patients were enrolled between July 2016 and October 2017 (median age 77.5 years [interquartile range (IQR): 70.3 to 82.8 years], 63.3% women, median Society of Thoracic Surgeons score 9.4% [IQR: 5.8% to 12.0%], 80% in New York Heart Association functional class III or IV). The technical success rate was 100%. The primary performance endpoint in survivors was achieved in 96.6% (28 of 29) at 30 days and 82.8% (24 of 29) at 1 year. Thirty-day all-cause mortality was 3.3% and was unchanged at 1 year. The only death was due to airway obstruction after swallowing several pills simultaneously 29 days post-MViV. At 1-year follow-up, 89.3% of patients were in New York Heart Association functional class I or II, the median mean mitral valve gradient was 6.6 mm Hg (interquartile range: 5.5 to 8.9 mm Hg), and all patients had MR grade ≤1+.
Transseptal MViV in high-risk patients was associated with 100% technical success, low procedural complication rates, and very low mortality at 1 year. The vast majority of patients experienced significant symptom alleviation, and THV performance remained stable at 1 year.</abstract><cop>United States</cop><pmid>33888231</pmid><doi>10.1016/j.jcin.2021.02.027</doi><tpages>14</tpages></addata></record> |
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| subjects | Aged Aged, 80 and over Bioprosthesis Cardiac Catheterization - adverse effects Female Heart Valve Prosthesis Heart Valve Prosthesis Implantation - adverse effects Humans Male Mitral Valve Annuloplasty Prospective Studies Prosthesis Design Treatment Outcome |
| title | Prospective Evaluation of Transseptal TMVR for Failed Surgical Bioprostheses: MITRAL Trial Valve-in-Valve Arm 1-Year Outcomes |
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