TY - JOUR
T1 - 2-Year Outcomes after Iliofemoral Self-Expanding Transcatheter Aortic Valve Replacement in Patients with Severe Aortic Stenosis Deemed Extreme Risk for Surgery
AU - Yakubov, Steven J.
AU - Adams, David H.
AU - Watson, Daniel R.
AU - Reardon, Michael J.
AU - Kleiman, Neal S.
AU - Heimansohn, David
AU - Hermiller, James
AU - Hughes, G. Chad
AU - Harrison, J. Kevin
AU - Coselli, Joseph
AU - Diez, Jose
AU - Schreiber, Theodore
AU - Gleason, Thomas G.
AU - Conte, John
AU - Deeb, G. Michael
AU - Huang, Jian
AU - Oh, Jae
AU - Byrne, Timothy
AU - Caskey, Michael
AU - Popma, Jeffrey J.
N1 - Funding Information:
Medtronic, Minneapolis, Minnesota, sponsored this study. Dr. Yakubov has received institutional research grants from Boston Scientific , Direct Flow Medical , and Medtronic ; and serves on an Advisory Board for Boston Scientific and Medtronic. Dr. Adams has received institutional grants and institutional royalties for patents from Medtronic; and institutional royalties for patents from Edwards Lifesciences. Dr. Reardon serves on an Advisory Board for Medtronic. Dr. Kleiman provides educational services to Medtronic. Dr. Heimansohn serves as a proctor for Sorin Biomedical. Dr. Hermiller has received institutional research grants from Medtronic . Dr. Hughes serves as a consultant and speaker for Medtronic. Dr. Harrison has received institutional research grants from Boston Scientific , Direct Flow Medical , Edwards Lifesciences , and Medtronic ; serves on an Advisory Board for St. Jude Medical; and is on a DSMB for CardiAQ. Dr. Coselli serves as an advisor to Medtronic. Dr. Gleason has received institutional research grants from Medtronic. Dr. Conte serves on the Surgery Advisory Board for Medtronic and Sorin; and has received research support from Boston Scientific, Medtronic, and St. Jude Medical. Dr. Deeb serves as a consultant for Edwards Lifesciences; and as an advisor and consultant for Medtronic. Dr. Huang is an employee of and shareholder in Medtronic. Dr. Oh has received institutional research grants from Medtronic. Dr. Caskey serves as a consultant for Medtronic. Dr. Popma has received institutional research grants from Boston Scientific, Direct Flow Medical, and Medtronic; and serves on a Medical Advisory Board for Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Antonio Colombo, MD, served as Guest Editor for this paper.
Publisher Copyright:
© 2015 American College of Cardiology Foundation.
PY - 2015/9/22
Y1 - 2015/9/22
N2 - Background We reported favorable 1-year outcomes in patients unsuitable for surgery who underwent self-expanding transcatheter aortic valve replacement (TAVR) compared with an objective performance goal. Longer-term outcomes in these patients are not known. Objectives This study sought to evaluate the 2-year safety and efficacy in patients with severe aortic stenosis (AS) at extreme risk of surgery treated with self-expanding TAVR. Methods We performed a prospective, multicenter, controlled, nonrandomized investigation of self-expanding TAVR in patients with severe AS and prohibitive surgical risk. We report the 2-year clinical outcomes in these patients. Results A total of 489 extreme-risk patients were treated transfemorally with a self-expanding aortic bioprosthesis at 41 centers. The rate of all-cause mortality or major stroke was 38.0% at 2 years (all-cause mortality, 36.5%; major stroke, 5.1%). The rates of all-cause mortality, cardiovascular mortality, and major stroke were 36.6%, 26.2%, and 5.1%, respectively, at 2 years. Between 1 and 2 years, the incremental all-cause mortality, cardiovascular mortality, and major stroke rates were 12.3%, 7.9%, and 0.8%, respectively. Multivariable predictors of all-cause mortality at 2 years included the presence of coronary artery disease and admission from an assisted living center. A Society of Thoracic Surgeons score >15% was also predictive of 2-year all-cause mortality. At 2 years, 94% of patients had New York Heart Association functional class I or II symptoms. The frequency of moderate or severe paravalvular regurgitation (4.3% at 1 year; 4.4% at 2 years) was unchanged between the first and second year. Conclusions Patients with severe AS at extreme surgical risk treated with self-expanding TAVR continued to show good clinical outcomes and hemodynamic valve performance at 2 years. The presence of comorbid conditions rather than valve performance affected 2-year outcomes in these patients.
AB - Background We reported favorable 1-year outcomes in patients unsuitable for surgery who underwent self-expanding transcatheter aortic valve replacement (TAVR) compared with an objective performance goal. Longer-term outcomes in these patients are not known. Objectives This study sought to evaluate the 2-year safety and efficacy in patients with severe aortic stenosis (AS) at extreme risk of surgery treated with self-expanding TAVR. Methods We performed a prospective, multicenter, controlled, nonrandomized investigation of self-expanding TAVR in patients with severe AS and prohibitive surgical risk. We report the 2-year clinical outcomes in these patients. Results A total of 489 extreme-risk patients were treated transfemorally with a self-expanding aortic bioprosthesis at 41 centers. The rate of all-cause mortality or major stroke was 38.0% at 2 years (all-cause mortality, 36.5%; major stroke, 5.1%). The rates of all-cause mortality, cardiovascular mortality, and major stroke were 36.6%, 26.2%, and 5.1%, respectively, at 2 years. Between 1 and 2 years, the incremental all-cause mortality, cardiovascular mortality, and major stroke rates were 12.3%, 7.9%, and 0.8%, respectively. Multivariable predictors of all-cause mortality at 2 years included the presence of coronary artery disease and admission from an assisted living center. A Society of Thoracic Surgeons score >15% was also predictive of 2-year all-cause mortality. At 2 years, 94% of patients had New York Heart Association functional class I or II symptoms. The frequency of moderate or severe paravalvular regurgitation (4.3% at 1 year; 4.4% at 2 years) was unchanged between the first and second year. Conclusions Patients with severe AS at extreme surgical risk treated with self-expanding TAVR continued to show good clinical outcomes and hemodynamic valve performance at 2 years. The presence of comorbid conditions rather than valve performance affected 2-year outcomes in these patients.
KW - Key Words extreme risk
KW - self-expanding
KW - severe aortic stenosis
KW - transcatheter aortic valve replacement
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U2 - 10.1016/j.jacc.2015.07.042
DO - 10.1016/j.jacc.2015.07.042
M3 - Article
C2 - 26383718
AN - SCOPUS:84942515745
SN - 0735-1097
VL - 66
SP - 1327
EP - 1334
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 12
ER -