Neurological Events Following Transcatheter Aortic Valve Replacement and Their Predictors: A Report From the CoreValve Trials.
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.



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.



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.



URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01240902, NCT01531374.
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.
Neal S
NS
Kleiman
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.).
Brijeshwar J
BJ
Maini
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.).
Michael J
MJ
Reardon
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.).
John
J
Conte
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.).
Stanley
S
Katz
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.).
Vivek
V
Rajagopal
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.).
James
J
Kauten
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.).
Alan
A
Hartman
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.).
Raymond
R
McKay
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.).
Robert
R
Hagberg
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.).
Jian
J
Huang
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.).
Jeffrey
J
Popma
D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000473:pathology* / Q000503:physiopathology / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D063126:Balloon Valvuloplasty / Q000009:adverse effects; D001705:Bioprosthesis; D002114:Calcinosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D002304:Cardiac Pacing, Artificial / Q000009:adverse effects; D002986:Clinical Trials as Topic; D005260:Female; D006350:Heart Valve Prosthesis; D006801:Humans; D015994:Incidence; D020766:Intracranial Embolism / Q000175:diagnosis / Q000453:epidemiology* / Q000401:mortality; D053208:Kaplan-Meier Estimate; D008297:Male; D016016:Proportional Hazards Models; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D020521:Stroke / Q000175:diagnosis / Q000453:epidemiology* / Q000401:mortality; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects* / Q000295:instrumentation / Q000401:mortality; D016896:Treatment Outcome
CoreValve; aortic valve stenosis; stroke; transcatheter aortic valve implantation; transient ischemic attack