Prosthesis–patient mismatch in high-risk patients with severe aortic stenosis: A randomized trial of a self-expanding prosthesis

Abstract Objectives We compared the incidence of prosthesis–patient mismatch (PPM) between transcatheter aortic valve replacement (TAVR) using a self-expanding bioprosthesis and surgical aortic valve replacement (SAVR) in the CoreValve US High Risk Pivotal Trial. We sought to determine the influence...

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Veröffentlicht in:	The Journal of thoracic and cardiovascular surgery 2016-04, Vol.151 (4), p.1014-1023.e3
Hauptverfasser:	Zorn, George L., MD, Little, Stephen H., MD, Tadros, Peter, MD, Deeb, G. Michael, MD, Gleason, Thomas G., MD, Heiser, John, MD, Kleiman, Neal S., MD, Oh, Jae K., MD, Popma, Jeffrey J., MD, Adams, David, MD, Huang, Jian, MD, Reardon, Michael J., MD
Format:	Artikel
Sprache:	eng
Schlagworte:	Acute Kidney Injury - epidemiology aortic stenosis Aortic Valve - diagnostic imaging Aortic Valve - physiopathology Aortic Valve - surgery Aortic Valve Stenosis - diagnosis Aortic Valve Stenosis - mortality Aortic Valve Stenosis - physiopathology Aortic Valve Stenosis - surgery Aortic Valve Stenosis - therapy Bioprosthesis Cardiac Catheterization - adverse effects Cardiac Catheterization - instrumentation Cardiac Catheterization - mortality Cardiothoracic Surgery Echocardiography, Doppler Heart Valve Prosthesis Heart Valve Prosthesis Implantation - adverse effects Heart Valve Prosthesis Implantation - instrumentation Heart Valve Prosthesis Implantation - mortality Humans Incidence Kaplan-Meier Estimate Postoperative Complications - diagnosis Postoperative Complications - epidemiology Postoperative Complications - mortality Proportional Hazards Models Prospective Studies Prosthesis Design prosthesis-patient mismatch Risk Assessment Risk Factors Severity of Illness Index Time Factors transcatheter aortic valve replacement Treatment Outcome United States - epidemiology Ventricular Function, Left Ventricular Remodeling
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Zusammenfassung:	Abstract Objectives We compared the incidence of prosthesis–patient mismatch (PPM) between transcatheter aortic valve replacement (TAVR) using a self-expanding bioprosthesis and surgical aortic valve replacement (SAVR) in the CoreValve US High Risk Pivotal Trial. We sought to determine the influence of PPM on clinical outcomes. Methods Patients with severe aortic stenosis and at increased risk for surgery were randomized 1:1 to TAVR or SAVR. Postoperative PPM was defined by the effective orifice area index (EOAi) as severe PPM (EOAi ≤ 0.65 cm2 /m2 ) and no severe PPM (EOAi > 0.65 cm2 /m2 ); clinical outcomes were analyzed in the TAVR arm (n = 389) and SAVR arm (n = 353). Left ventricular mass index and regression were analyzed at baseline and 1 year. Results The incidence of severe PPM in the SAVR group at 1 year was 25.7% versus 6.2% in the TAVR group ( P
ISSN:	0022-5223 1097-685X
DOI:	10.1016/j.jtcvs.2015.10.070