Novel Transcatheter Mitral Valve Prosthesis for Patients With Severe Mitral Annular Calcification

Treatment of mitral regurgitation (MR) in the setting of severe mitral annular calcification (MAC) is challenging due to the high risk for fatal atrioventricular groove disruption and significant paravalvular leak. The objective of this study was to evaluate the potential for transcatheter mitral va...

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Published inJournal of the American College of Cardiology Vol. 74; no. 11; pp. 1431 - 1440
Main Authors Sorajja, Paul, Gössl, Mario, Babaliaros, Vasilis, Rizik, David, Conradi, Lenard, Bae, Richard, Burke, Robert F., Schäfer, Ulrich, Lisko, John C., Riley, Robert D., Guyton, Robert, Dumonteil, Nicolas, Berthoumieu, Pierre, Tchetche, Didier, Blanke, Philipp, Cavalcante, João L., Sun, Benjamin
Format Journal Article
LanguageEnglish
Published United States Elsevier Inc 17.09.2019
Elsevier Limited
Subjects
Online AccessGet full text
ISSN0735-1097
1558-3597
1558-3597
DOI10.1016/j.jacc.2019.07.069

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Abstract Treatment of mitral regurgitation (MR) in the setting of severe mitral annular calcification (MAC) is challenging due to the high risk for fatal atrioventricular groove disruption and significant paravalvular leak. The objective of this study was to evaluate the potential for transcatheter mitral valve replacement in patients with severe MAC using an anatomically designed mitral prosthesis. Nine patients (77 ± 6 years of age; 5 men) were treated with the valve, using transapical delivery performed under general anesthesia and with guidance from transesophageal echocardiography and fluoroscopy. Device implantation was successful with relief of MR in all 9 patients. There were no procedural deaths. In 1 patient, left ventricular outflow tract obstruction occurred due to malrotation of the prosthesis, and successful alcohol septal ablation was performed. During a median follow-up of 12 months (range 1 to 28 months), there was 1 cardiac death, 1 noncardiac death, no other mortality, and no prosthetic dysfunction, and MR remained absent in all treated patients. Rehospitalization for heart failure occurred in 2 patients who did not die subsequently. Clinical improvement with mild or no symptoms occurred in all patients alive at the end of follow-up. Transcatheter mitral valve replacement in severe mitral annular calcification with a dedicated prosthesis is feasible and can result in MR relief with symptom improvement. Further evaluation of this approach for these high-risk patients is warranted. [Display omitted]
AbstractList Treatment of mitral regurgitation (MR) in the setting of severe mitral annular calcification (MAC) is challenging due to the high risk for fatal atrioventricular groove disruption and significant paravalvular leak.BACKGROUNDTreatment of mitral regurgitation (MR) in the setting of severe mitral annular calcification (MAC) is challenging due to the high risk for fatal atrioventricular groove disruption and significant paravalvular leak.The objective of this study was to evaluate the potential for transcatheter mitral valve replacement in patients with severe MAC using an anatomically designed mitral prosthesis.OBJECTIVESThe objective of this study was to evaluate the potential for transcatheter mitral valve replacement in patients with severe MAC using an anatomically designed mitral prosthesis.Nine patients (77 ± 6 years of age; 5 men) were treated with the valve, using transapical delivery performed under general anesthesia and with guidance from transesophageal echocardiography and fluoroscopy.METHODSNine patients (77 ± 6 years of age; 5 men) were treated with the valve, using transapical delivery performed under general anesthesia and with guidance from transesophageal echocardiography and fluoroscopy.Device implantation was successful with relief of MR in all 9 patients. There were no procedural deaths. In 1 patient, left ventricular outflow tract obstruction occurred due to malrotation of the prosthesis, and successful alcohol septal ablation was performed. During a median follow-up of 12 months (range 1 to 28 months), there was 1 cardiac death, 1 noncardiac death, no other mortality, and no prosthetic dysfunction, and MR remained absent in all treated patients. Rehospitalization for heart failure occurred in 2 patients who did not die subsequently. Clinical improvement with mild or no symptoms occurred in all patients alive at the end of follow-up.RESULTSDevice implantation was successful with relief of MR in all 9 patients. There were no procedural deaths. In 1 patient, left ventricular outflow tract obstruction occurred due to malrotation of the prosthesis, and successful alcohol septal ablation was performed. During a median follow-up of 12 months (range 1 to 28 months), there was 1 cardiac death, 1 noncardiac death, no other mortality, and no prosthetic dysfunction, and MR remained absent in all treated patients. Rehospitalization for heart failure occurred in 2 patients who did not die subsequently. Clinical improvement with mild or no symptoms occurred in all patients alive at the end of follow-up.Transcatheter mitral valve replacement in severe mitral annular calcification with a dedicated prosthesis is feasible and can result in MR relief with symptom improvement. Further evaluation of this approach for these high-risk patients is warranted.CONCLUSIONSTranscatheter mitral valve replacement in severe mitral annular calcification with a dedicated prosthesis is feasible and can result in MR relief with symptom improvement. Further evaluation of this approach for these high-risk patients is warranted.
Treatment of mitral regurgitation (MR) in the setting of severe mitral annular calcification (MAC) is challenging due to the high risk for fatal atrioventricular groove disruption and significant paravalvular leak. The objective of this study was to evaluate the potential for transcatheter mitral valve replacement in patients with severe MAC using an anatomically designed mitral prosthesis. Nine patients (77 ± 6 years of age; 5 men) were treated with the valve, using transapical delivery performed under general anesthesia and with guidance from transesophageal echocardiography and fluoroscopy. Device implantation was successful with relief of MR in all 9 patients. There were no procedural deaths. In 1 patient, left ventricular outflow tract obstruction occurred due to malrotation of the prosthesis, and successful alcohol septal ablation was performed. During a median follow-up of 12 months (range 1 to 28 months), there was 1 cardiac death, 1 noncardiac death, no other mortality, and no prosthetic dysfunction, and MR remained absent in all treated patients. Rehospitalization for heart failure occurred in 2 patients who did not die subsequently. Clinical improvement with mild or no symptoms occurred in all patients alive at the end of follow-up. Transcatheter mitral valve replacement in severe mitral annular calcification with a dedicated prosthesis is feasible and can result in MR relief with symptom improvement. Further evaluation of this approach for these high-risk patients is warranted. [Display omitted]
AbstractBackgroundTreatment of mitral regurgitation (MR) in the setting of severe mitral annular calcification (MAC) is challenging due to the high risk for fatal atrioventricular groove disruption and significant paravalvular leak. ObjectivesThe objective of this study was to evaluate the potential for transcatheter mitral valve replacement in patients with severe MAC using an anatomically designed mitral prosthesis. MethodsNine patients (77 ± 6 years of age; 5 men) were treated with the valve, using transapical delivery performed under general anesthesia and with guidance from transesophageal echocardiography and fluoroscopy. ResultsDevice implantation was successful with relief of MR in all 9 patients. There were no procedural deaths. In 1 patient, left ventricular outflow tract obstruction occurred due to malrotation of the prosthesis, and successful alcohol septal ablation was performed. During a median follow-up of 12 months (range 1 to 28 months), there was 1 cardiac death, 1 noncardiac death, no other mortality, and no prosthetic dysfunction, and MR remained absent in all treated patients. Rehospitalization for heart failure occurred in 2 patients who did not die subsequently. Clinical improvement with mild or no symptoms occurred in all patients alive at the end of follow-up. ConclusionsTranscatheter mitral valve replacement in severe mitral annular calcification with a dedicated prosthesis is feasible and can result in MR relief with symptom improvement. Further evaluation of this approach for these high-risk patients is warranted.
Treatment of mitral regurgitation (MR) in the setting of severe mitral annular calcification (MAC) is challenging due to the high risk for fatal atrioventricular groove disruption and significant paravalvular leak. The objective of this study was to evaluate the potential for transcatheter mitral valve replacement in patients with severe MAC using an anatomically designed mitral prosthesis. Nine patients (77 ± 6 years of age; 5 men) were treated with the valve, using transapical delivery performed under general anesthesia and with guidance from transesophageal echocardiography and fluoroscopy. Device implantation was successful with relief of MR in all 9 patients. There were no procedural deaths. In 1 patient, left ventricular outflow tract obstruction occurred due to malrotation of the prosthesis, and successful alcohol septal ablation was performed. During a median follow-up of 12 months (range 1 to 28 months), there was 1 cardiac death, 1 noncardiac death, no other mortality, and no prosthetic dysfunction, and MR remained absent in all treated patients. Rehospitalization for heart failure occurred in 2 patients who did not die subsequently. Clinical improvement with mild or no symptoms occurred in all patients alive at the end of follow-up. Transcatheter mitral valve replacement in severe mitral annular calcification with a dedicated prosthesis is feasible and can result in MR relief with symptom improvement. Further evaluation of this approach for these high-risk patients is warranted.
BackgroundTreatment of mitral regurgitation (MR) in the setting of severe mitral annular calcification (MAC) is challenging due to the high risk for fatal atrioventricular groove disruption and significant paravalvular leak.ObjectivesThe objective of this study was to evaluate the potential for transcatheter mitral valve replacement in patients with severe MAC using an anatomically designed mitral prosthesis.MethodsNine patients (77 ± 6 years of age; 5 men) were treated with the valve, using transapical delivery performed under general anesthesia and with guidance from transesophageal echocardiography and fluoroscopy.ResultsDevice implantation was successful with relief of MR in all 9 patients. There were no procedural deaths. In 1 patient, left ventricular outflow tract obstruction occurred due to malrotation of the prosthesis, and successful alcohol septal ablation was performed. During a median follow-up of 12 months (range 1 to 28 months), there was 1 cardiac death, 1 noncardiac death, no other mortality, and no prosthetic dysfunction, and MR remained absent in all treated patients. Rehospitalization for heart failure occurred in 2 patients who did not die subsequently. Clinical improvement with mild or no symptoms occurred in all patients alive at the end of follow-up.ConclusionsTranscatheter mitral valve replacement in severe mitral annular calcification with a dedicated prosthesis is feasible and can result in MR relief with symptom improvement. Further evaluation of this approach for these high-risk patients is warranted.
Author Tchetche, Didier
Rizik, David
Sorajja, Paul
Gössl, Mario
Sun, Benjamin
Babaliaros, Vasilis
Berthoumieu, Pierre
Lisko, John C.
Guyton, Robert
Blanke, Philipp
Cavalcante, João L.
Schäfer, Ulrich
Burke, Robert F.
Dumonteil, Nicolas
Bae, Richard
Conradi, Lenard
Riley, Robert D.
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  surname: Sorajja
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  organization: Emory Structural Heart and Valve Center, Atlanta, Georgia
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  organization: University Heart Center, Hamburg, Germany
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  organization: Valve Science Center, Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, Minnesota
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  organization: University Heart Center, Hamburg, Germany
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  organization: Emory Structural Heart and Valve Center, Atlanta, Georgia
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  organization: HonorHealth, Phoenix, Arizona
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  fullname: Guyton, Robert
  organization: Emory Structural Heart and Valve Center, Atlanta, Georgia
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  surname: Dumonteil
  fullname: Dumonteil, Nicolas
  organization: Clinique Pasteur, Toulouse, France
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  surname: Berthoumieu
  fullname: Berthoumieu, Pierre
  organization: Clinique Pasteur, Toulouse, France
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  fullname: Cavalcante, João L.
  organization: Valve Science Center, Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, Minnesota
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  givenname: Benjamin
  surname: Sun
  fullname: Sun, Benjamin
  organization: Valve Science Center, Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, Minnesota
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Issue 11
Keywords mitral annular calcification
NYHA
TMVR
MR
EOA
transcatheter
LVOT
mitral valve replacement
MAC
mitral regurgitation
left ventricular outflow tract
effective orifice area
New York Heart Association
transcatheter mitral valve replacement
Language English
License This article is made available under the Elsevier license.
Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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Snippet Treatment of mitral regurgitation (MR) in the setting of severe mitral annular calcification (MAC) is challenging due to the high risk for fatal...
AbstractBackgroundTreatment of mitral regurgitation (MR) in the setting of severe mitral annular calcification (MAC) is challenging due to the high risk for...
BackgroundTreatment of mitral regurgitation (MR) in the setting of severe mitral annular calcification (MAC) is challenging due to the high risk for fatal...
Treatment of mitral regurgitation (MR) in the setting of severe mitral annular calcification (MAC) is challenging due to the high risk for fatal...
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SubjectTerms Aged
Aged, 80 and over
Anesthesia
Anticoagulants
Calcification
Calcinosis - surgery
Cardiac arrhythmia
Cardiac Catheterization
Cardiology
Cardiovascular
Catheters
Congestive heart failure
Echocardiography
Endocarditis
Feasibility studies
Female
Fluoroscopy
Heart attacks
Heart failure
Heart Valve Diseases - surgery
Heart Valve Prosthesis Implantation - methods
Hospitalization
Hospitals
Humans
Hypertension
Male
Medical equipment
mitral annular calcification
Mitral valve
Mitral Valve - surgery
mitral valve replacement
Mortality
Ostomy
Patients
Prostheses
Regurgitation
Risk groups
Severity of Illness Index
Stroke
Surgery
Thoracic surgery
transcatheter
Ventricle
Title Novel Transcatheter Mitral Valve Prosthesis for Patients With Severe Mitral Annular Calcification
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https://dx.doi.org/10.1016/j.jacc.2019.07.069
https://www.ncbi.nlm.nih.gov/pubmed/31514943
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https://www.proquest.com/docview/2290900816
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