Regression of Paravalvular Aortic Regurgitation and Remodeling of Self-Expanding Transcatheter Aortic Valve

An Observation from the CoreValve U.S. Pivotal Trial

Jae K. Oh, Stephen H. Little, Sahar S. Abdelmoneim, Michael J. Reardon, Neal S. Kleiman, Grace Lin, David Bach, Linda Gillam, Biswajit Kar, Joseph Coselli, Partho P. Sengupta, Kanny Grewal, James Chang, Yanping Chang, Mike Boulware, David H. Adams, Jeffrey J. Popma

Research output: Contribution to journalArticle

46 Citations (Scopus)

Abstract

Objectives The aim of this study was to describe the natural history and clinical importance of paravalvular aortic regurgitation (PVAR) after CoreValve transcatheter aortic valve replacement (TAVR) and to relate these findings to the structural and hemodynamic changes documented by serial echocardiographic analysis. Background PVAR after TAVR with the self-expanding CoreValve bioprosthesis has been shown to regress over time, but the time course and the mechanism of PVAR regression has not been completely characterized. Methods Patients with severe aortic stenosis who underwent CoreValve TAVR and followed up to 1 year in the multicenter CoreValve U.S. Pivotal Trial (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement) were studied. Serial echocardiography studies were analyzed by an echocardiographic core laboratory. Annular sizing ratio was calculated from computed tomography measurements. Paired, as well as total, data were compared. Results The CoreValve was implanted in 634 patients with a mean age of 82.7 ± 8.4 years. After a marked improvement noted at discharge, aortic valve velocity, mean gradient, and effective orifice area further improved significantly at 1 month (2.08 ± 0.45 m/s vs. 1.99 ± 0.46 m/s, p < 0.0001, 9.7 ± 4.4 mm Hg vs. 8.9 ± 4.6 mm Hg, p < 0.0001, and 1.78 ± 0.51 cm2 vs. 1.85 ± 0.58 cm2, p = 0.03, respectively). The improvement was sustained through 1 year. PVAR was moderate or severe in 9.9%, and of 36 patients with moderate PVAR at discharge and paired data, 30 (83%) improved at least 1 grade of regurgitation at 1 year. Annular sizing ratio was significantly associated with the degree of PVAR. Conclusions There was further improvement in aortic prosthetic valve hemodynamics and regression of PVAR up to 1 year compared with discharge after TAVR with CoreValve. These changes are possibly due to remodeling and outward expansion of the self-expandable CoreValve with nitinol frame. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement [Medtronic CoreValve U.S. Pivotal Trial]; NCT01240902)

Original languageEnglish (US)
Pages (from-to)1364-1375
Number of pages12
JournalJACC: Cardiovascular Imaging
Volume8
Issue number12
DOIs
StatePublished - Dec 1 2015
Externally publishedYes

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Aortic Valve Insufficiency
Aortic Valve
Observation
Aortic Valve Stenosis
Hemodynamics
Safety
Bioprosthesis
Natural History
Echocardiography
Tomography
Transcatheter Aortic Valve Replacement
Therapeutics

All Science Journal Classification (ASJC) codes

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

Oh, Jae K. ; Little, Stephen H. ; Abdelmoneim, Sahar S. ; Reardon, Michael J. ; Kleiman, Neal S. ; Lin, Grace ; Bach, David ; Gillam, Linda ; Kar, Biswajit ; Coselli, Joseph ; Sengupta, Partho P. ; Grewal, Kanny ; Chang, James ; Chang, Yanping ; Boulware, Mike ; Adams, David H. ; Popma, Jeffrey J. / Regression of Paravalvular Aortic Regurgitation and Remodeling of Self-Expanding Transcatheter Aortic Valve : An Observation from the CoreValve U.S. Pivotal Trial. In: JACC: Cardiovascular Imaging. 2015 ; Vol. 8, No. 12. pp. 1364-1375.
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title = "Regression of Paravalvular Aortic Regurgitation and Remodeling of Self-Expanding Transcatheter Aortic Valve: An Observation from the CoreValve U.S. Pivotal Trial",
abstract = "Objectives The aim of this study was to describe the natural history and clinical importance of paravalvular aortic regurgitation (PVAR) after CoreValve transcatheter aortic valve replacement (TAVR) and to relate these findings to the structural and hemodynamic changes documented by serial echocardiographic analysis. Background PVAR after TAVR with the self-expanding CoreValve bioprosthesis has been shown to regress over time, but the time course and the mechanism of PVAR regression has not been completely characterized. Methods Patients with severe aortic stenosis who underwent CoreValve TAVR and followed up to 1 year in the multicenter CoreValve U.S. Pivotal Trial (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement) were studied. Serial echocardiography studies were analyzed by an echocardiographic core laboratory. Annular sizing ratio was calculated from computed tomography measurements. Paired, as well as total, data were compared. Results The CoreValve was implanted in 634 patients with a mean age of 82.7 ± 8.4 years. After a marked improvement noted at discharge, aortic valve velocity, mean gradient, and effective orifice area further improved significantly at 1 month (2.08 ± 0.45 m/s vs. 1.99 ± 0.46 m/s, p < 0.0001, 9.7 ± 4.4 mm Hg vs. 8.9 ± 4.6 mm Hg, p < 0.0001, and 1.78 ± 0.51 cm2 vs. 1.85 ± 0.58 cm2, p = 0.03, respectively). The improvement was sustained through 1 year. PVAR was moderate or severe in 9.9{\%}, and of 36 patients with moderate PVAR at discharge and paired data, 30 (83{\%}) improved at least 1 grade of regurgitation at 1 year. Annular sizing ratio was significantly associated with the degree of PVAR. Conclusions There was further improvement in aortic prosthetic valve hemodynamics and regression of PVAR up to 1 year compared with discharge after TAVR with CoreValve. These changes are possibly due to remodeling and outward expansion of the self-expandable CoreValve with nitinol frame. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement [Medtronic CoreValve U.S. Pivotal Trial]; NCT01240902)",
author = "Oh, {Jae K.} and Little, {Stephen H.} and Abdelmoneim, {Sahar S.} and Reardon, {Michael J.} and Kleiman, {Neal S.} and Grace Lin and David Bach and Linda Gillam and Biswajit Kar and Joseph Coselli and Sengupta, {Partho P.} and Kanny Grewal and James Chang and Yanping Chang and Mike Boulware and Adams, {David H.} and Popma, {Jeffrey J.}",
year = "2015",
month = "12",
day = "1",
doi = "10.1016/j.jcmg.2015.07.012",
language = "English (US)",
volume = "8",
pages = "1364--1375",
journal = "JACC: Cardiovascular Imaging",
issn = "1936-878X",
publisher = "Elsevier Inc.",
number = "12",

}

Oh, JK, Little, SH, Abdelmoneim, SS, Reardon, MJ, Kleiman, NS, Lin, G, Bach, D, Gillam, L, Kar, B, Coselli, J, Sengupta, PP, Grewal, K, Chang, J, Chang, Y, Boulware, M, Adams, DH & Popma, JJ 2015, 'Regression of Paravalvular Aortic Regurgitation and Remodeling of Self-Expanding Transcatheter Aortic Valve: An Observation from the CoreValve U.S. Pivotal Trial', JACC: Cardiovascular Imaging, vol. 8, no. 12, pp. 1364-1375. https://doi.org/10.1016/j.jcmg.2015.07.012

Regression of Paravalvular Aortic Regurgitation and Remodeling of Self-Expanding Transcatheter Aortic Valve : An Observation from the CoreValve U.S. Pivotal Trial. / Oh, Jae K.; Little, Stephen H.; Abdelmoneim, Sahar S.; Reardon, Michael J.; Kleiman, Neal S.; Lin, Grace; Bach, David; Gillam, Linda; Kar, Biswajit; Coselli, Joseph; Sengupta, Partho P.; Grewal, Kanny; Chang, James; Chang, Yanping; Boulware, Mike; Adams, David H.; Popma, Jeffrey J.

In: JACC: Cardiovascular Imaging, Vol. 8, No. 12, 01.12.2015, p. 1364-1375.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Regression of Paravalvular Aortic Regurgitation and Remodeling of Self-Expanding Transcatheter Aortic Valve

T2 - An Observation from the CoreValve U.S. Pivotal Trial

AU - Oh, Jae K.

AU - Little, Stephen H.

AU - Abdelmoneim, Sahar S.

AU - Reardon, Michael J.

AU - Kleiman, Neal S.

AU - Lin, Grace

AU - Bach, David

AU - Gillam, Linda

AU - Kar, Biswajit

AU - Coselli, Joseph

AU - Sengupta, Partho P.

AU - Grewal, Kanny

AU - Chang, James

AU - Chang, Yanping

AU - Boulware, Mike

AU - Adams, David H.

AU - Popma, Jeffrey J.

PY - 2015/12/1

Y1 - 2015/12/1

N2 - Objectives The aim of this study was to describe the natural history and clinical importance of paravalvular aortic regurgitation (PVAR) after CoreValve transcatheter aortic valve replacement (TAVR) and to relate these findings to the structural and hemodynamic changes documented by serial echocardiographic analysis. Background PVAR after TAVR with the self-expanding CoreValve bioprosthesis has been shown to regress over time, but the time course and the mechanism of PVAR regression has not been completely characterized. Methods Patients with severe aortic stenosis who underwent CoreValve TAVR and followed up to 1 year in the multicenter CoreValve U.S. Pivotal Trial (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement) were studied. Serial echocardiography studies were analyzed by an echocardiographic core laboratory. Annular sizing ratio was calculated from computed tomography measurements. Paired, as well as total, data were compared. Results The CoreValve was implanted in 634 patients with a mean age of 82.7 ± 8.4 years. After a marked improvement noted at discharge, aortic valve velocity, mean gradient, and effective orifice area further improved significantly at 1 month (2.08 ± 0.45 m/s vs. 1.99 ± 0.46 m/s, p < 0.0001, 9.7 ± 4.4 mm Hg vs. 8.9 ± 4.6 mm Hg, p < 0.0001, and 1.78 ± 0.51 cm2 vs. 1.85 ± 0.58 cm2, p = 0.03, respectively). The improvement was sustained through 1 year. PVAR was moderate or severe in 9.9%, and of 36 patients with moderate PVAR at discharge and paired data, 30 (83%) improved at least 1 grade of regurgitation at 1 year. Annular sizing ratio was significantly associated with the degree of PVAR. Conclusions There was further improvement in aortic prosthetic valve hemodynamics and regression of PVAR up to 1 year compared with discharge after TAVR with CoreValve. These changes are possibly due to remodeling and outward expansion of the self-expandable CoreValve with nitinol frame. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement [Medtronic CoreValve U.S. Pivotal Trial]; NCT01240902)

AB - Objectives The aim of this study was to describe the natural history and clinical importance of paravalvular aortic regurgitation (PVAR) after CoreValve transcatheter aortic valve replacement (TAVR) and to relate these findings to the structural and hemodynamic changes documented by serial echocardiographic analysis. Background PVAR after TAVR with the self-expanding CoreValve bioprosthesis has been shown to regress over time, but the time course and the mechanism of PVAR regression has not been completely characterized. Methods Patients with severe aortic stenosis who underwent CoreValve TAVR and followed up to 1 year in the multicenter CoreValve U.S. Pivotal Trial (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement) were studied. Serial echocardiography studies were analyzed by an echocardiographic core laboratory. Annular sizing ratio was calculated from computed tomography measurements. Paired, as well as total, data were compared. Results The CoreValve was implanted in 634 patients with a mean age of 82.7 ± 8.4 years. After a marked improvement noted at discharge, aortic valve velocity, mean gradient, and effective orifice area further improved significantly at 1 month (2.08 ± 0.45 m/s vs. 1.99 ± 0.46 m/s, p < 0.0001, 9.7 ± 4.4 mm Hg vs. 8.9 ± 4.6 mm Hg, p < 0.0001, and 1.78 ± 0.51 cm2 vs. 1.85 ± 0.58 cm2, p = 0.03, respectively). The improvement was sustained through 1 year. PVAR was moderate or severe in 9.9%, and of 36 patients with moderate PVAR at discharge and paired data, 30 (83%) improved at least 1 grade of regurgitation at 1 year. Annular sizing ratio was significantly associated with the degree of PVAR. Conclusions There was further improvement in aortic prosthetic valve hemodynamics and regression of PVAR up to 1 year compared with discharge after TAVR with CoreValve. These changes are possibly due to remodeling and outward expansion of the self-expandable CoreValve with nitinol frame. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement [Medtronic CoreValve U.S. Pivotal Trial]; NCT01240902)

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DO - 10.1016/j.jcmg.2015.07.012

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EP - 1375

JO - JACC: Cardiovascular Imaging

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