Initial Experience with Commercial Transcatheter Mitral Valve Repair in the United States

Paul Sorajja*, Michael MacK, Sreekanth Vemulapalli, David R. Holmes, Amanda Stebbins, Saibal Kar, D. Scott Lim, Vinod Thourani, Patrick M McCarthy, Samir Kapadia, Paul Grayburn, Wesley A. Pedersen, Gorav Ailawadi

*Corresponding author for this work

Research output: Contribution to journalArticle

85 Citations (Scopus)

Abstract

Background Transcatheter mitral valve (MV) repair with the MitraClip received approval in 2013 for the treatment of prohibitive-risk patients with primary mitral regurgitation (MR). Objectives The aim of this study was to report the initial U.S. commercial experience with transcatheter MV repair. Methods Data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry on patients commercially treated with this percutaneous mitral valve repair device were analyzed. Results Of 564 patients (56% men, median age 83 years), severe symptoms were present in 473 (86.0%). The median Society of Thoracic Surgeons Predicted Risk of Mortality scores for MV repair and replacement were 7.9% (interquartile range: 4.7% to 12.2%) and 10.0% (interquartile range: 6.3% to 14.5%), respectively. Frailty was noted in 323 patients (57.3%). Transcatheter MV repair was performed for degenerative disease, present in 90.8% of patients. Overall, MR was reduced to grade ≤2 in 93.0%. In-hospital mortality was 2.3%; 30-day mortality was 5.8%. Other 30-day events were stroke (1.8%), bleeding (2.6%), and device-related complications (1.4%). The median length of stay was 3 days (interquartile range: 1 to 6 days), with 84.0% patients discharged home. Overall, procedure success occurred in 90.6%. Variables associated with reduction in MR were end-diastolic dimension, MR severity, clip location, and case volume. Conclusions In this study of the initial commercial U.S. experience, it was found that procedural success was achieved in approximately 91% of patients, and the majority of patients were discharged home with moderate or less MR. These data support the effectiveness of this therapy in appropriately selected high-risk patients in a commercial setting. Further study is required to determine the long-term impact of transcatheter MV repair in this patient population.

Original languageEnglish (US)
Pages (from-to)1129-1140
Number of pages12
JournalJournal of the American College of Cardiology
Volume67
Issue number10
DOIs
StatePublished - Mar 15 2016

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Mitral Valve
Mitral Valve Insufficiency
Equipment and Supplies
Mortality
Hospital Mortality
Surgical Instruments
Registries
Length of Stay
Therapeutics
Stroke
Hemorrhage

Keywords

  • Key Words mitral regurgitation
  • mitral repair
  • transcatheter

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Sorajja, P., MacK, M., Vemulapalli, S., Holmes, D. R., Stebbins, A., Kar, S., ... Ailawadi, G. (2016). Initial Experience with Commercial Transcatheter Mitral Valve Repair in the United States. Journal of the American College of Cardiology, 67(10), 1129-1140. https://doi.org/10.1016/j.jacc.2015.12.054
Sorajja, Paul ; MacK, Michael ; Vemulapalli, Sreekanth ; Holmes, David R. ; Stebbins, Amanda ; Kar, Saibal ; Lim, D. Scott ; Thourani, Vinod ; McCarthy, Patrick M ; Kapadia, Samir ; Grayburn, Paul ; Pedersen, Wesley A. ; Ailawadi, Gorav. / Initial Experience with Commercial Transcatheter Mitral Valve Repair in the United States. In: Journal of the American College of Cardiology. 2016 ; Vol. 67, No. 10. pp. 1129-1140.
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title = "Initial Experience with Commercial Transcatheter Mitral Valve Repair in the United States",
abstract = "Background Transcatheter mitral valve (MV) repair with the MitraClip received approval in 2013 for the treatment of prohibitive-risk patients with primary mitral regurgitation (MR). Objectives The aim of this study was to report the initial U.S. commercial experience with transcatheter MV repair. Methods Data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry on patients commercially treated with this percutaneous mitral valve repair device were analyzed. Results Of 564 patients (56{\%} men, median age 83 years), severe symptoms were present in 473 (86.0{\%}). The median Society of Thoracic Surgeons Predicted Risk of Mortality scores for MV repair and replacement were 7.9{\%} (interquartile range: 4.7{\%} to 12.2{\%}) and 10.0{\%} (interquartile range: 6.3{\%} to 14.5{\%}), respectively. Frailty was noted in 323 patients (57.3{\%}). Transcatheter MV repair was performed for degenerative disease, present in 90.8{\%} of patients. Overall, MR was reduced to grade ≤2 in 93.0{\%}. In-hospital mortality was 2.3{\%}; 30-day mortality was 5.8{\%}. Other 30-day events were stroke (1.8{\%}), bleeding (2.6{\%}), and device-related complications (1.4{\%}). The median length of stay was 3 days (interquartile range: 1 to 6 days), with 84.0{\%} patients discharged home. Overall, procedure success occurred in 90.6{\%}. Variables associated with reduction in MR were end-diastolic dimension, MR severity, clip location, and case volume. Conclusions In this study of the initial commercial U.S. experience, it was found that procedural success was achieved in approximately 91{\%} of patients, and the majority of patients were discharged home with moderate or less MR. These data support the effectiveness of this therapy in appropriately selected high-risk patients in a commercial setting. Further study is required to determine the long-term impact of transcatheter MV repair in this patient population.",
keywords = "Key Words mitral regurgitation, mitral repair, transcatheter",
author = "Paul Sorajja and Michael MacK and Sreekanth Vemulapalli and Holmes, {David R.} and Amanda Stebbins and Saibal Kar and Lim, {D. Scott} and Vinod Thourani and McCarthy, {Patrick M} and Samir Kapadia and Paul Grayburn and Pedersen, {Wesley A.} and Gorav Ailawadi",
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Sorajja, P, MacK, M, Vemulapalli, S, Holmes, DR, Stebbins, A, Kar, S, Lim, DS, Thourani, V, McCarthy, PM, Kapadia, S, Grayburn, P, Pedersen, WA & Ailawadi, G 2016, 'Initial Experience with Commercial Transcatheter Mitral Valve Repair in the United States', Journal of the American College of Cardiology, vol. 67, no. 10, pp. 1129-1140. https://doi.org/10.1016/j.jacc.2015.12.054

Initial Experience with Commercial Transcatheter Mitral Valve Repair in the United States. / Sorajja, Paul; MacK, Michael; Vemulapalli, Sreekanth; Holmes, David R.; Stebbins, Amanda; Kar, Saibal; Lim, D. Scott; Thourani, Vinod; McCarthy, Patrick M; Kapadia, Samir; Grayburn, Paul; Pedersen, Wesley A.; Ailawadi, Gorav.

In: Journal of the American College of Cardiology, Vol. 67, No. 10, 15.03.2016, p. 1129-1140.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Initial Experience with Commercial Transcatheter Mitral Valve Repair in the United States

AU - Sorajja, Paul

AU - MacK, Michael

AU - Vemulapalli, Sreekanth

AU - Holmes, David R.

AU - Stebbins, Amanda

AU - Kar, Saibal

AU - Lim, D. Scott

AU - Thourani, Vinod

AU - McCarthy, Patrick M

AU - Kapadia, Samir

AU - Grayburn, Paul

AU - Pedersen, Wesley A.

AU - Ailawadi, Gorav

PY - 2016/3/15

Y1 - 2016/3/15

N2 - Background Transcatheter mitral valve (MV) repair with the MitraClip received approval in 2013 for the treatment of prohibitive-risk patients with primary mitral regurgitation (MR). Objectives The aim of this study was to report the initial U.S. commercial experience with transcatheter MV repair. Methods Data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry on patients commercially treated with this percutaneous mitral valve repair device were analyzed. Results Of 564 patients (56% men, median age 83 years), severe symptoms were present in 473 (86.0%). The median Society of Thoracic Surgeons Predicted Risk of Mortality scores for MV repair and replacement were 7.9% (interquartile range: 4.7% to 12.2%) and 10.0% (interquartile range: 6.3% to 14.5%), respectively. Frailty was noted in 323 patients (57.3%). Transcatheter MV repair was performed for degenerative disease, present in 90.8% of patients. Overall, MR was reduced to grade ≤2 in 93.0%. In-hospital mortality was 2.3%; 30-day mortality was 5.8%. Other 30-day events were stroke (1.8%), bleeding (2.6%), and device-related complications (1.4%). The median length of stay was 3 days (interquartile range: 1 to 6 days), with 84.0% patients discharged home. Overall, procedure success occurred in 90.6%. Variables associated with reduction in MR were end-diastolic dimension, MR severity, clip location, and case volume. Conclusions In this study of the initial commercial U.S. experience, it was found that procedural success was achieved in approximately 91% of patients, and the majority of patients were discharged home with moderate or less MR. These data support the effectiveness of this therapy in appropriately selected high-risk patients in a commercial setting. Further study is required to determine the long-term impact of transcatheter MV repair in this patient population.

AB - Background Transcatheter mitral valve (MV) repair with the MitraClip received approval in 2013 for the treatment of prohibitive-risk patients with primary mitral regurgitation (MR). Objectives The aim of this study was to report the initial U.S. commercial experience with transcatheter MV repair. Methods Data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry on patients commercially treated with this percutaneous mitral valve repair device were analyzed. Results Of 564 patients (56% men, median age 83 years), severe symptoms were present in 473 (86.0%). The median Society of Thoracic Surgeons Predicted Risk of Mortality scores for MV repair and replacement were 7.9% (interquartile range: 4.7% to 12.2%) and 10.0% (interquartile range: 6.3% to 14.5%), respectively. Frailty was noted in 323 patients (57.3%). Transcatheter MV repair was performed for degenerative disease, present in 90.8% of patients. Overall, MR was reduced to grade ≤2 in 93.0%. In-hospital mortality was 2.3%; 30-day mortality was 5.8%. Other 30-day events were stroke (1.8%), bleeding (2.6%), and device-related complications (1.4%). The median length of stay was 3 days (interquartile range: 1 to 6 days), with 84.0% patients discharged home. Overall, procedure success occurred in 90.6%. Variables associated with reduction in MR were end-diastolic dimension, MR severity, clip location, and case volume. Conclusions In this study of the initial commercial U.S. experience, it was found that procedural success was achieved in approximately 91% of patients, and the majority of patients were discharged home with moderate or less MR. These data support the effectiveness of this therapy in appropriately selected high-risk patients in a commercial setting. Further study is required to determine the long-term impact of transcatheter MV repair in this patient population.

KW - Key Words mitral regurgitation

KW - mitral repair

KW - transcatheter

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