Neal S Kleiman1, Brijeshwar J Maini2, Michael J Reardon2, John Conte2, Stanley Katz2, Vivek Rajagopal2, James Kauten2, Alan Hartman2, Raymond McKay2, Robert Hagberg2, Jian Huang2, Jeffrey Popma2. 1. From the Houston Methodist DeBakey Heart and Vascular Institute, TX (N.S.K., M.J.R.); Tenet Healthcare Corporation, Delray Beach, FL (B.J.M.); Johns Hopkins University, Baltimore, MD (J.C.); Hofstra North Shore University Hospital, New Hyde Park, NY (S.K., A.H.); Hartford Hospital, CT (R.M., R. H.); Piedmont Heart Institute, Atlanta, GA (V.R., J.K.); Medtronic, Minneapolis, MN (J.H.); and Beth Israel Deaconess Medical Center, Boston, MA (J.J.P.). nkleiman@houstonmethodist.org. 2. From the Houston Methodist DeBakey Heart and Vascular Institute, TX (N.S.K., M.J.R.); Tenet Healthcare Corporation, Delray Beach, FL (B.J.M.); Johns Hopkins University, Baltimore, MD (J.C.); Hofstra North Shore University Hospital, New Hyde Park, NY (S.K., A.H.); Hartford Hospital, CT (R.M., R. H.); Piedmont Heart Institute, Atlanta, GA (V.R., J.K.); Medtronic, Minneapolis, MN (J.H.); and Beth Israel Deaconess Medical Center, Boston, MA (J.J.P.).
Abstract
BACKGROUND: The risk for stroke after transcatheter aortic valve replacement (TAVR) is an important concern. Identification of predictors for stroke is likely to be a critical factor aiding patient selection and management as TAVR use becomes widespread. METHODS AND RESULTS: Patients enrolled in the CoreValve US Extreme Risk and High Risk Pivotal Trials or Continued Access Study treated with the self-expanding CoreValve bioprosthesis were included in this analysis. The 1-year stroke rate after TAVR was 8.4%. Analysis of the stroke hazard rate identified an early phase (0-10 days; 4.1% of strokes) and a late phase (11-365 days; 4.3% of strokes). Baseline predictors of early stroke included National Institutes of Health stroke scale score >0, prior stroke, prior transient ischemic attack, peripheral vascular disease, absence of prior coronary artery bypass surgery, angina, low body mass index (<21 kg/m(2)), and falls within the past 6 months. Significant procedural predictors were total time in the catheterization laboratory or operating room, delivery catheter in the body time, rapid pacing used during valvuloplasty, and repositioning of the prosthesis. Predictors of stroke between 11 and 365 days were small body surface area, severe aortic calcification, and falls within the past 6 months. There were no significant imaging predictors of early or late stroke. CONCLUSIONS: Predictors of early stroke after TAVR included clinical and procedural factors; predictors of later stroke were limited to patient but not anatomic characteristics. These findings indicate that further refinement of imaging to identify anatomic factors predisposing to embolization may help improve stroke prediction in patients undergoing TAVR. CLINICAL TRIAL REGISTRATIONS: URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01240902, NCT01531374.
BACKGROUND: The risk for stroke after transcatheter aortic valve replacement (TAVR) is an important concern. Identification of predictors for stroke is likely to be a critical factor aiding patient selection and management as TAVR use becomes widespread. METHODS AND RESULTS:Patients enrolled in the CoreValve US Extreme Risk and High Risk Pivotal Trials or Continued Access Study treated with the self-expanding CoreValve bioprosthesis were included in this analysis. The 1-year stroke rate after TAVR was 8.4%. Analysis of the stroke hazard rate identified an early phase (0-10 days; 4.1% of strokes) and a late phase (11-365 days; 4.3% of strokes). Baseline predictors of early stroke included National Institutes of Health stroke scale score >0, prior stroke, prior transient ischemic attack, peripheral vascular disease, absence of prior coronary artery bypass surgery, angina, low body mass index (<21 kg/m(2)), and falls within the past 6 months. Significant procedural predictors were total time in the catheterization laboratory or operating room, delivery catheter in the body time, rapid pacing used during valvuloplasty, and repositioning of the prosthesis. Predictors of stroke between 11 and 365 days were small body surface area, severe aortic calcification, and falls within the past 6 months. There were no significant imaging predictors of early or late stroke. CONCLUSIONS: Predictors of early stroke after TAVR included clinical and procedural factors; predictors of later stroke were limited to patient but not anatomic characteristics. These findings indicate that further refinement of imaging to identify anatomic factors predisposing to embolization may help improve stroke prediction in patients undergoing TAVR. CLINICAL TRIAL REGISTRATIONS: URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01240902, NCT01531374.
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