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.
N1 - Funding Information:
Dr. Oh has received research support for the echocardiographic core laboratory from Medtronic; and has received research funding from Toshiba. Dr. Little is on the Speakers Bureau for St. Jude Medical; and has received grant support from Medtronic, Abbott Vascular, and St. Jude Medical. Dr. Reardon is a consultant to Boston Scientific; and provides educational services and serves on an advisory board for Medtronic. Dr. Kleiman provides educational services to Medtronic. Dr. Bach has received research grants from Medtronic, Edwards Lifesciences, and St. Jude Medical; and has received consulting fees from Boston Scientific, Medtronic, Edwards Lifesciences, and NeoChord. Dr. Gillam has core laboratory contracts with Edwards Lifesciences, Middlepeak, and Medtronic. Dr. Coselli is an advisor to Medtronic; and is the principal investigator and receives per-patient payment in clinical trials for Edwards Lifesciences and Medtronic. Dr. Sengupta is a consultant to Edwards Lifesciences; and is an advisor to TeleHealth Robotics, Saffron Technologies, and Heart Test Labs. Mr. Y. Chang and Dr. Boulware are employees and shareholders of Medtronic. Dr. Adams has royalty agreements through Mount Sinai School of Medicine with Edwards Lifesciences and Medtronic; and has received research funding from Medtronic. Dr. Popma has received research grants to his institution from Abbott Vascular, Abiomed, Boston Scientific, Cordis Corporation, Covidien, Direct Flow Medical, eV3, and Medtronic; and serves on the medical advisory boards of Boston Scientific and Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Publisher Copyright:
© 2015 American College of Cardiology Foundation.
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.
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.
KW - CoreValve self-expansion
KW - paravalvular aortic regurgitation regression
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U2 - 10.1016/j.jcmg.2015.07.012
DO - 10.1016/j.jcmg.2015.07.012
M3 - Article
C2 - 26508386
AN - SCOPUS:84959189321
SN - 1936-878X
VL - 8
SP - 1364
EP - 1375
JO - JACC: Cardiovascular Imaging
JF - JACC: Cardiovascular Imaging
IS - 12
ER -