Thirty-Day Outcomes of Transcatheter Mitral Valve Replacement for Degenerated Mitral Bioprostheses (Valve-in-Valve), Failed Surgical Rings (Valve-in-Ring), and Native Valve With Severe Mitral Annular Calcification (Valve-in-Mitral Annular Calcification) in the United States: Data From the Society of Thoracic Surgeons/American College of Cardiology/Transcatheter Valve Therapy Registry
Transcatheter mitral valve replacement using aortic transcatheter heart valves has recently become an alternative for patients with degenerated mitral bioprostheses, failed surgical repairs with annuloplasty rings or severe mitral annular calcification who are poor surgical candidates. Outcomes of t...
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          | Published in | Circulation. Cardiovascular interventions Vol. 13; no. 3; p. e008425 | 
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , | 
| Format | Journal Article | 
| Language | English | 
| Published | 
        United States
          American Heart Association, Inc
    
        01.03.2020
     | 
| Subjects | |
| Online Access | Get full text | 
| ISSN | 1941-7640 1941-7632 1941-7632  | 
| DOI | 10.1161/CIRCINTERVENTIONS.119.008425 | 
Cover
| Abstract | Transcatheter mitral valve replacement using aortic transcatheter heart valves has recently become an alternative for patients with degenerated mitral bioprostheses, failed surgical repairs with annuloplasty rings or severe mitral annular calcification who are poor surgical candidates. Outcomes of these procedures are collected in the Society of Thoracic Surgeons/American College of Cardiology/Transcatheter Valve Therapy Registry. A comprehensive analysis of mitral valve-in-valve (MViV), mitral valve-in-ring (MViR), and valve-in-mitral annular calcification (ViMAC) outcomes has not been performed. We sought to evaluate short-term outcomes of early experience with MViV, MViR, and ViMAC in the United States.
Retrospective analysis of data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.
Nine hundred three high-risk patients (median Society of Thoracic Surgeons score 10%) underwent MViV (n=680), MViR (n=123), or ViMAC (n=100) between March 2013 and June 2017 at 172 hospitals. Median age was 75 years, 59.2% female. Technical and procedural success were higher in MViV. Left ventricular outflow tract obstruction occurred more frequently with ViMAC (ViMAC=10%, MViR=4.9%, MViV=0.7%;
<0.001). In-hospital mortality (MViV=6.3%, MViR=9%, ViMAC=18%;
=0.004) and 30-day mortality (MViV=8.1%, MViR=11.5%, ViMAC=21.8%;
=0.003) were higher in ViMAC. At 30-day follow-up, median mean mitral valve gradient was 7 mm Hg, most patients (96.7%) had mitral regurgitation grade ≤1 (+) and were in New York Heart Association class I to II (81.7%).
MViV using aortic balloon-expandable transcatheter heart valves is associated with a low complication rate, a 30-day mortality lower than predicted by the Society of Thoracic Surgeons score, and superior short-term outcomes than MViR and ViMAC. At 30 days, patients in all groups experienced improvement of symptoms, and valve performance remained stable. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02245763. | 
    
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| AbstractList | Transcatheter mitral valve replacement using aortic transcatheter heart valves has recently become an alternative for patients with degenerated mitral bioprostheses, failed surgical repairs with annuloplasty rings or severe mitral annular calcification who are poor surgical candidates. Outcomes of these procedures are collected in the Society of Thoracic Surgeons/American College of Cardiology/Transcatheter Valve Therapy Registry. A comprehensive analysis of mitral valve-in-valve (MViV), mitral valve-in-ring (MViR), and valve-in-mitral annular calcification (ViMAC) outcomes has not been performed. We sought to evaluate short-term outcomes of early experience with MViV, MViR, and ViMAC in the United States.
Retrospective analysis of data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.
Nine hundred three high-risk patients (median Society of Thoracic Surgeons score 10%) underwent MViV (n=680), MViR (n=123), or ViMAC (n=100) between March 2013 and June 2017 at 172 hospitals. Median age was 75 years, 59.2% female. Technical and procedural success were higher in MViV. Left ventricular outflow tract obstruction occurred more frequently with ViMAC (ViMAC=10%, MViR=4.9%, MViV=0.7%;
<0.001). In-hospital mortality (MViV=6.3%, MViR=9%, ViMAC=18%;
=0.004) and 30-day mortality (MViV=8.1%, MViR=11.5%, ViMAC=21.8%;
=0.003) were higher in ViMAC. At 30-day follow-up, median mean mitral valve gradient was 7 mm Hg, most patients (96.7%) had mitral regurgitation grade ≤1 (+) and were in New York Heart Association class I to II (81.7%).
MViV using aortic balloon-expandable transcatheter heart valves is associated with a low complication rate, a 30-day mortality lower than predicted by the Society of Thoracic Surgeons score, and superior short-term outcomes than MViR and ViMAC. At 30 days, patients in all groups experienced improvement of symptoms, and valve performance remained stable. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02245763. Transcatheter mitral valve replacement using aortic transcatheter heart valves has recently become an alternative for patients with degenerated mitral bioprostheses, failed surgical repairs with annuloplasty rings or severe mitral annular calcification who are poor surgical candidates. Outcomes of these procedures are collected in the Society of Thoracic Surgeons/American College of Cardiology/Transcatheter Valve Therapy Registry. A comprehensive analysis of mitral valve-in-valve (MViV), mitral valve-in-ring (MViR), and valve-in-mitral annular calcification (ViMAC) outcomes has not been performed. We sought to evaluate short-term outcomes of early experience with MViV, MViR, and ViMAC in the United States.BACKGROUNDTranscatheter mitral valve replacement using aortic transcatheter heart valves has recently become an alternative for patients with degenerated mitral bioprostheses, failed surgical repairs with annuloplasty rings or severe mitral annular calcification who are poor surgical candidates. Outcomes of these procedures are collected in the Society of Thoracic Surgeons/American College of Cardiology/Transcatheter Valve Therapy Registry. A comprehensive analysis of mitral valve-in-valve (MViV), mitral valve-in-ring (MViR), and valve-in-mitral annular calcification (ViMAC) outcomes has not been performed. We sought to evaluate short-term outcomes of early experience with MViV, MViR, and ViMAC in the United States.Retrospective analysis of data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.METHODSRetrospective analysis of data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.Nine hundred three high-risk patients (median Society of Thoracic Surgeons score 10%) underwent MViV (n=680), MViR (n=123), or ViMAC (n=100) between March 2013 and June 2017 at 172 hospitals. Median age was 75 years, 59.2% female. Technical and procedural success were higher in MViV. Left ventricular outflow tract obstruction occurred more frequently with ViMAC (ViMAC=10%, MViR=4.9%, MViV=0.7%; P<0.001). In-hospital mortality (MViV=6.3%, MViR=9%, ViMAC=18%; P=0.004) and 30-day mortality (MViV=8.1%, MViR=11.5%, ViMAC=21.8%; P=0.003) were higher in ViMAC. At 30-day follow-up, median mean mitral valve gradient was 7 mm Hg, most patients (96.7%) had mitral regurgitation grade ≤1 (+) and were in New York Heart Association class I to II (81.7%).RESULTSNine hundred three high-risk patients (median Society of Thoracic Surgeons score 10%) underwent MViV (n=680), MViR (n=123), or ViMAC (n=100) between March 2013 and June 2017 at 172 hospitals. Median age was 75 years, 59.2% female. Technical and procedural success were higher in MViV. Left ventricular outflow tract obstruction occurred more frequently with ViMAC (ViMAC=10%, MViR=4.9%, MViV=0.7%; P<0.001). In-hospital mortality (MViV=6.3%, MViR=9%, ViMAC=18%; P=0.004) and 30-day mortality (MViV=8.1%, MViR=11.5%, ViMAC=21.8%; P=0.003) were higher in ViMAC. At 30-day follow-up, median mean mitral valve gradient was 7 mm Hg, most patients (96.7%) had mitral regurgitation grade ≤1 (+) and were in New York Heart Association class I to II (81.7%).MViV using aortic balloon-expandable transcatheter heart valves is associated with a low complication rate, a 30-day mortality lower than predicted by the Society of Thoracic Surgeons score, and superior short-term outcomes than MViR and ViMAC. At 30 days, patients in all groups experienced improvement of symptoms, and valve performance remained stable. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02245763.CONCLUSIONSMViV using aortic balloon-expandable transcatheter heart valves is associated with a low complication rate, a 30-day mortality lower than predicted by the Society of Thoracic Surgeons score, and superior short-term outcomes than MViR and ViMAC. At 30 days, patients in all groups experienced improvement of symptoms, and valve performance remained stable. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02245763.  | 
    
| Author | Wang, Dee Dee Cabalka, Allison K. Greenbaum, Adam Whisenant, Brian Russo, Mark J. Tommaso, Carl Dvir, Danny Pershad, Ashish Babaliaros, Vasilis Sandhu, Gurpreet Kar, Saibal Russell, Hyde Saucedo, Jorge Rihal, Charanjit Eleid, Mackram Bapat, Vinayak Mack, Michael Xiang, Qun Leon, Martin Shah, Pinak Kodali, Susheel Holmes, David Salinger, Michael O’Neill, William Feldman, Ted Makkar, Rajj Khan, Jaffar M. George, Isaac Coylewright, Megan Fang, Kenith Vemulapalli, Sreekanth Thourani, Vinod H. Guerrero, Mayra  | 
    
| AuthorAffiliation | Department of Cardiovascular Medicine, Mayo Clinic Hospital, Rochester, MN (M.G., M.E., A.K.C., G.S., D.H., C.R.). Duke Clinical Research Institute, Durham, NC (S.V., Q.X.). Center for Structural Heart Disease, Henry Ford Hospital (D.D.W., W.O.). Division of Cardiology, Froedtert Medical College of Wisconsin, Milwaukee (M.S.). Division of Cardiovascular Surgery (H.R.), NorthShore University Health System, Evanston, IL. Division of Cardiology (C.T., T.F.), NorthShore University Health System, Evanston, IL. Structural Heart and Valve Center, Emory University, Atlanta, GA (A.G., V.B.). Division of Cardiology (S.K., M.L.) Department of Surgery, Columbia University Medical Center, New York (I.G., V.B.). Division of Cardiology, University of Washington Medical Center, Seattle (D.D.). Division of Cardiology, Intermountain Heart Institute, Salt Lake City, UT (B.W.). Department of Surgery, Rutgers Robert Wood Johnson Medical School in New Brunswick, NJ (M.J.R.). Division of Cardiology (A.P.), B | 
    
| AuthorAffiliation_xml | – name: Department of Cardiovascular Medicine, Mayo Clinic Hospital, Rochester, MN (M.G., M.E., A.K.C., G.S., D.H., C.R.). Duke Clinical Research Institute, Durham, NC (S.V., Q.X.). Center for Structural Heart Disease, Henry Ford Hospital (D.D.W., W.O.). Division of Cardiology, Froedtert Medical College of Wisconsin, Milwaukee (M.S.). Division of Cardiovascular Surgery (H.R.), NorthShore University Health System, Evanston, IL. Division of Cardiology (C.T., T.F.), NorthShore University Health System, Evanston, IL. Structural Heart and Valve Center, Emory University, Atlanta, GA (A.G., V.B.). Division of Cardiology (S.K., M.L.) Department of Surgery, Columbia University Medical Center, New York (I.G., V.B.). Division of Cardiology, University of Washington Medical Center, Seattle (D.D.). Division of Cardiology, Intermountain Heart Institute, Salt Lake City, UT (B.W.). Department of Surgery, Rutgers Robert Wood Johnson Medical School in New Brunswick, NJ (M.J.R.). Division of Cardiology (A.P.), Banner University Medical Center, Phoenix, AZ. Department of Surgery (K.F.), Banner University Medical Center, Phoenix, AZ. Division of Cardiology, Dartmouth-Hitchcock Medical Center, Lebanon, NH (M.C.). Division of Cardiology, Brigham and Women’s Hospital, Brighton, MA (P.S.). Cardiovascular and Pulmonary Branch, Division of Intramural Research, National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, MD (J.M.K.). Division of Cardiology, Cedar’s Sinai Medical Center, Los Angeles, CA (S.K., R.M.). Department of Surgery, Heart Hospital Baylor Plano, Baylor Healthcare System, TX (M.M.). Department of Cardiovascular Surgery, Marcus Valve Center, Piedmont Heart Institute, Atlanta, GA (V. H.T.) | 
    
| Author_xml | – sequence: 1 givenname: Mayra surname: Guerrero fullname: Guerrero, Mayra organization: Department of Cardiovascular Medicine, Mayo Clinic Hospital, Rochester, MN (M.G., M.E., A.K.C., G.S., D.H., C.R.). Duke Clinical Research Institute, Durham, NC (S.V., Q.X.). Center for Structural Heart Disease, Henry Ford Hospital (D.D.W., W.O.). Division of Cardiology, Froedtert Medical College of Wisconsin, Milwaukee (M.S.). Division of Cardiovascular Surgery (H.R.), NorthShore University Health System, Evanston, IL. Division of Cardiology (C.T., T.F.), NorthShore University Health System, Evanston, IL. Structural Heart and Valve Center, Emory University, Atlanta, GA (A.G., V.B.). Division of Cardiology (S.K., M.L.) Department of Surgery, Columbia University Medical Center, New York (I.G., V.B.). Division of Cardiology, University of Washington Medical Center, Seattle (D.D.). Division of Cardiology, Intermountain Heart Institute, Salt Lake City, UT (B.W.). Department of Surgery, Rutgers Robert Wood Johnson Medical School in New Brunswick, NJ (M.J.R.). Division of Cardiology (A.P.), Banner University Medical Center, Phoenix, AZ. Department of Surgery (K.F.), Banner University Medical Center, Phoenix, AZ. Division of Cardiology, Dartmouth-Hitchcock Medical Center, Lebanon, NH (M.C.). Division of Cardiology, Brigham and Women’s Hospital, Brighton, MA (P.S.). Cardiovascular and Pulmonary Branch, Division of Intramural Research, National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, MD (J.M.K.). Division of Cardiology, Cedar’s Sinai Medical Center, Los Angeles, CA (S.K., R.M.). Department of Surgery, Heart Hospital Baylor Plano, Baylor Healthcare System, TX (M.M.). Department of Cardiovascular Surgery, Marcus Valve Center, Piedmont Heart Institute, Atlanta, GA (V. H.T.) – sequence: 2 givenname: Sreekanth surname: Vemulapalli fullname: Vemulapalli, Sreekanth – sequence: 3 givenname: Qun surname: Xiang fullname: Xiang, Qun – sequence: 4 givenname: Dee surname: Wang middlename: Dee fullname: Wang, Dee Dee – sequence: 5 givenname: Mackram surname: Eleid fullname: Eleid, Mackram – sequence: 6 givenname: Allison surname: Cabalka middlename: K. fullname: Cabalka, Allison K. – sequence: 7 givenname: Gurpreet surname: Sandhu fullname: Sandhu, Gurpreet – sequence: 8 givenname: Michael surname: Salinger fullname: Salinger, Michael – sequence: 9 givenname: Hyde surname: Russell fullname: Russell, Hyde – sequence: 10 givenname: Adam surname: Greenbaum fullname: Greenbaum, Adam – sequence: 11 givenname: Susheel surname: Kodali fullname: Kodali, Susheel – sequence: 12 givenname: Isaac surname: George fullname: George, Isaac – sequence: 13 givenname: Danny surname: Dvir fullname: Dvir, Danny – sequence: 14 givenname: Brian surname: Whisenant fullname: Whisenant, Brian – sequence: 15 givenname: Mark surname: Russo middlename: J. fullname: Russo, Mark J. – sequence: 16 givenname: Ashish surname: Pershad fullname: Pershad, Ashish – sequence: 17 givenname: Kenith surname: Fang fullname: Fang, Kenith – sequence: 18 givenname: Megan surname: Coylewright fullname: Coylewright, Megan – sequence: 19 givenname: Pinak surname: Shah fullname: Shah, Pinak – sequence: 20 givenname: Vasilis surname: Babaliaros fullname: Babaliaros, Vasilis – sequence: 21 givenname: Jaffar surname: Khan middlename: M. fullname: Khan, Jaffar M. – sequence: 22 givenname: Carl surname: Tommaso fullname: Tommaso, Carl – sequence: 23 givenname: Jorge surname: Saucedo fullname: Saucedo, Jorge – sequence: 24 givenname: Saibal surname: Kar fullname: Kar, Saibal – sequence: 25 givenname: Rajj surname: Makkar fullname: Makkar, Rajj – sequence: 26 givenname: Michael surname: Mack fullname: Mack, Michael – sequence: 27 givenname: David surname: Holmes fullname: Holmes, David – sequence: 28 givenname: Martin surname: Leon fullname: Leon, Martin – sequence: 29 givenname: Vinayak surname: Bapat fullname: Bapat, Vinayak – sequence: 30 givenname: Vinod surname: Thourani middlename: H. fullname: Thourani, Vinod H. – sequence: 31 givenname: Charanjit surname: Rihal fullname: Rihal, Charanjit – sequence: 32 givenname: William surname: O’Neill fullname: O’Neill, William – sequence: 33 givenname: Ted surname: Feldman fullname: Feldman, Ted  | 
    
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/32138529$$D View this record in MEDLINE/PubMed | 
    
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