Insights Into Timing, Risk Factors, and Outcomes of Stroke and Transient Ischemic Attack After Transcatheter Aortic Valve Replacement in the PARTNER Trial (Placement of Aortic Transcatheter Valves).
Prior studies of stroke and transient ischemic attack (TIA) after transcatheter aortic valve replacement (TAVR) are limited by reporting and follow-up variability. This is a comprehensive analysis of time-related incidence, risk factors, and outcomes of these events.



From April 2007 to February 2012, 2621 patients, aged 84±7.2 years, underwent transfemoral (TF; 1521) or transapical (TA; 1100) TAVR in the PARTNER trial (Placement of Aortic Transcatheter Valves; as-treated), including the continued access registry. Stroke and TIA were identified by protocol and adjudicated by a Clinical Events Committee. Within 30 days of TAVR, 87 (3.3%) patients experienced a stroke (TF 58 [3.8%]; TA 29 [2.7%]; P=0.09), 85% within 1 week. Instantaneous stroke risk peaked on day 2, then fell to a low prolonged risk of 0.8% by 1 to 2 weeks. Within 30 days, 13 (0.50%) patients experienced a TIA (TF 10 [0.67%]; TA 3 [0.27%]; P>0.17). Stroke and TIA were associated with lower 1-year survival than expected (TF 47% after stroke versus 82%, and 64% after TIA versus 83%; TA 53% after stroke versus 80%, and 64% after TIA versus 83%). Risk factors for early stroke after TA-TAVR included more postdilatations, pure aortic stenosis without regurgitation, and possibly more pacing runs, earlier date of procedure, and no dual antiplatelet therapy; high pre-TAVR aortic peak gradient was a risk factor for stroke early after TF-TAVR.



Risk of stroke or TIA is highest early after TAVR and is associated with increased 1-year mortality. Modifications of TAVR, emboli-prevention devices, and better intraprocedural pharmacological protection may mitigate this risk.



URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.
From the Cleveland Clinic, OH (S. Kapadia, S.A., S.E., E.M.T., L.G.S., J.R., J.E., E.H.B.); Stanford University Medical School, CA (D.C.M.); St. Paul's Hospital, University of British Columbia, Vancouver (J.G.W.); Baylor Scott and White Health, Plano, TX (M.M.); Hospital of the University of Pennsylvania, Philadelphia (H.C.H.); MedStar Washington Hospital Center, DC (A.D.P.); Columbia University Medical Center/New York-Presbyterian Hospital (C.R.S., S. Kodali, M.B.L.); Cedars Sinai Medical Center, Los Angeles, CA (R.M.); and Emory University, Atlanta, GA (V.H.T.). kapadis@ccf.org.
Samir
S
Kapadia
From the Cleveland Clinic, OH (S. Kapadia, S.A., S.E., E.M.T., L.G.S., J.R., J.E., E.H.B.); Stanford University Medical School, CA (D.C.M.); St. Paul's Hospital, University of British Columbia, Vancouver (J.G.W.); Baylor Scott and White Health, Plano, TX (M.M.); Hospital of the University of Pennsylvania, Philadelphia (H.C.H.); MedStar Washington Hospital Center, DC (A.D.P.); Columbia University Medical Center/New York-Presbyterian Hospital (C.R.S., S. Kodali, M.B.L.); Cedars Sinai Medical Center, Los Angeles, CA (R.M.); and Emory University, Atlanta, GA (V.H.T.).
Shikhar
S
Agarwal
From the Cleveland Clinic, OH (S. Kapadia, S.A., S.E., E.M.T., L.G.S., J.R., J.E., E.H.B.); Stanford University Medical School, CA (D.C.M.); St. Paul's Hospital, University of British Columbia, Vancouver (J.G.W.); Baylor Scott and White Health, Plano, TX (M.M.); Hospital of the University of Pennsylvania, Philadelphia (H.C.H.); MedStar Washington Hospital Center, DC (A.D.P.); Columbia University Medical Center/New York-Presbyterian Hospital (C.R.S., S. Kodali, M.B.L.); Cedars Sinai Medical Center, Los Angeles, CA (R.M.); and Emory University, Atlanta, GA (V.H.T.).
D Craig
DC
Miller
From the Cleveland Clinic, OH (S. Kapadia, S.A., S.E., E.M.T., L.G.S., J.R., J.E., E.H.B.); Stanford University Medical School, CA (D.C.M.); St. Paul's Hospital, University of British Columbia, Vancouver (J.G.W.); Baylor Scott and White Health, Plano, TX (M.M.); Hospital of the University of Pennsylvania, Philadelphia (H.C.H.); MedStar Washington Hospital Center, DC (A.D.P.); Columbia University Medical Center/New York-Presbyterian Hospital (C.R.S., S. Kodali, M.B.L.); Cedars Sinai Medical Center, Los Angeles, CA (R.M.); and Emory University, Atlanta, GA (V.H.T.).
John G
JG
Webb
From the Cleveland Clinic, OH (S. Kapadia, S.A., S.E., E.M.T., L.G.S., J.R., J.E., E.H.B.); Stanford University Medical School, CA (D.C.M.); St. Paul's Hospital, University of British Columbia, Vancouver (J.G.W.); Baylor Scott and White Health, Plano, TX (M.M.); Hospital of the University of Pennsylvania, Philadelphia (H.C.H.); MedStar Washington Hospital Center, DC (A.D.P.); Columbia University Medical Center/New York-Presbyterian Hospital (C.R.S., S. Kodali, M.B.L.); Cedars Sinai Medical Center, Los Angeles, CA (R.M.); and Emory University, Atlanta, GA (V.H.T.).
Michael
M
Mack
From the Cleveland Clinic, OH (S. Kapadia, S.A., S.E., E.M.T., L.G.S., J.R., J.E., E.H.B.); Stanford University Medical School, CA (D.C.M.); St. Paul's Hospital, University of British Columbia, Vancouver (J.G.W.); Baylor Scott and White Health, Plano, TX (M.M.); Hospital of the University of Pennsylvania, Philadelphia (H.C.H.); MedStar Washington Hospital Center, DC (A.D.P.); Columbia University Medical Center/New York-Presbyterian Hospital (C.R.S., S. Kodali, M.B.L.); Cedars Sinai Medical Center, Los Angeles, CA (R.M.); and Emory University, Atlanta, GA (V.H.T.).
Stephen
S
Ellis
From the Cleveland Clinic, OH (S. Kapadia, S.A., S.E., E.M.T., L.G.S., J.R., J.E., E.H.B.); Stanford University Medical School, CA (D.C.M.); St. Paul's Hospital, University of British Columbia, Vancouver (J.G.W.); Baylor Scott and White Health, Plano, TX (M.M.); Hospital of the University of Pennsylvania, Philadelphia (H.C.H.); MedStar Washington Hospital Center, DC (A.D.P.); Columbia University Medical Center/New York-Presbyterian Hospital (C.R.S., S. Kodali, M.B.L.); Cedars Sinai Medical Center, Los Angeles, CA (R.M.); and Emory University, Atlanta, GA (V.H.T.).
Howard C
HC
Herrmann
From the Cleveland Clinic, OH (S. Kapadia, S.A., S.E., E.M.T., L.G.S., J.R., J.E., E.H.B.); Stanford University Medical School, CA (D.C.M.); St. Paul's Hospital, University of British Columbia, Vancouver (J.G.W.); Baylor Scott and White Health, Plano, TX (M.M.); Hospital of the University of Pennsylvania, Philadelphia (H.C.H.); MedStar Washington Hospital Center, DC (A.D.P.); Columbia University Medical Center/New York-Presbyterian Hospital (C.R.S., S. Kodali, M.B.L.); Cedars Sinai Medical Center, Los Angeles, CA (R.M.); and Emory University, Atlanta, GA (V.H.T.).
Augusto D
AD
Pichard
From the Cleveland Clinic, OH (S. Kapadia, S.A., S.E., E.M.T., L.G.S., J.R., J.E., E.H.B.); Stanford University Medical School, CA (D.C.M.); St. Paul's Hospital, University of British Columbia, Vancouver (J.G.W.); Baylor Scott and White Health, Plano, TX (M.M.); Hospital of the University of Pennsylvania, Philadelphia (H.C.H.); MedStar Washington Hospital Center, DC (A.D.P.); Columbia University Medical Center/New York-Presbyterian Hospital (C.R.S., S. Kodali, M.B.L.); Cedars Sinai Medical Center, Los Angeles, CA (R.M.); and Emory University, Atlanta, GA (V.H.T.).
E Murat
EM
Tuzcu
From the Cleveland Clinic, OH (S. Kapadia, S.A., S.E., E.M.T., L.G.S., J.R., J.E., E.H.B.); Stanford University Medical School, CA (D.C.M.); St. Paul's Hospital, University of British Columbia, Vancouver (J.G.W.); Baylor Scott and White Health, Plano, TX (M.M.); Hospital of the University of Pennsylvania, Philadelphia (H.C.H.); MedStar Washington Hospital Center, DC (A.D.P.); Columbia University Medical Center/New York-Presbyterian Hospital (C.R.S., S. Kodali, M.B.L.); Cedars Sinai Medical Center, Los Angeles, CA (R.M.); and Emory University, Atlanta, GA (V.H.T.).
Lars G
LG
Svensson
From the Cleveland Clinic, OH (S. Kapadia, S.A., S.E., E.M.T., L.G.S., J.R., J.E., E.H.B.); Stanford University Medical School, CA (D.C.M.); St. Paul's Hospital, University of British Columbia, Vancouver (J.G.W.); Baylor Scott and White Health, Plano, TX (M.M.); Hospital of the University of Pennsylvania, Philadelphia (H.C.H.); MedStar Washington Hospital Center, DC (A.D.P.); Columbia University Medical Center/New York-Presbyterian Hospital (C.R.S., S. Kodali, M.B.L.); Cedars Sinai Medical Center, Los Angeles, CA (R.M.); and Emory University, Atlanta, GA (V.H.T.).
Craig R
CR
Smith
From the Cleveland Clinic, OH (S. Kapadia, S.A., S.E., E.M.T., L.G.S., J.R., J.E., E.H.B.); Stanford University Medical School, CA (D.C.M.); St. Paul's Hospital, University of British Columbia, Vancouver (J.G.W.); Baylor Scott and White Health, Plano, TX (M.M.); Hospital of the University of Pennsylvania, Philadelphia (H.C.H.); MedStar Washington Hospital Center, DC (A.D.P.); Columbia University Medical Center/New York-Presbyterian Hospital (C.R.S., S. Kodali, M.B.L.); Cedars Sinai Medical Center, Los Angeles, CA (R.M.); and Emory University, Atlanta, GA (V.H.T.).
Jeevanantham
J
Rajeswaran
From the Cleveland Clinic, OH (S. Kapadia, S.A., S.E., E.M.T., L.G.S., J.R., J.E., E.H.B.); Stanford University Medical School, CA (D.C.M.); St. Paul's Hospital, University of British Columbia, Vancouver (J.G.W.); Baylor Scott and White Health, Plano, TX (M.M.); Hospital of the University of Pennsylvania, Philadelphia (H.C.H.); MedStar Washington Hospital Center, DC (A.D.P.); Columbia University Medical Center/New York-Presbyterian Hospital (C.R.S., S. Kodali, M.B.L.); Cedars Sinai Medical Center, Los Angeles, CA (R.M.); and Emory University, Atlanta, GA (V.H.T.).
John
J
Ehrlinger
From the Cleveland Clinic, OH (S. Kapadia, S.A., S.E., E.M.T., L.G.S., J.R., J.E., E.H.B.); Stanford University Medical School, CA (D.C.M.); St. Paul's Hospital, University of British Columbia, Vancouver (J.G.W.); Baylor Scott and White Health, Plano, TX (M.M.); Hospital of the University of Pennsylvania, Philadelphia (H.C.H.); MedStar Washington Hospital Center, DC (A.D.P.); Columbia University Medical Center/New York-Presbyterian Hospital (C.R.S., S. Kodali, M.B.L.); Cedars Sinai Medical Center, Los Angeles, CA (R.M.); and Emory University, Atlanta, GA (V.H.T.).
Susheel
S
Kodali
From the Cleveland Clinic, OH (S. Kapadia, S.A., S.E., E.M.T., L.G.S., J.R., J.E., E.H.B.); Stanford University Medical School, CA (D.C.M.); St. Paul's Hospital, University of British Columbia, Vancouver (J.G.W.); Baylor Scott and White Health, Plano, TX (M.M.); Hospital of the University of Pennsylvania, Philadelphia (H.C.H.); MedStar Washington Hospital Center, DC (A.D.P.); Columbia University Medical Center/New York-Presbyterian Hospital (C.R.S., S. Kodali, M.B.L.); Cedars Sinai Medical Center, Los Angeles, CA (R.M.); and Emory University, Atlanta, GA (V.H.T.).
Raj
R
Makkar
From the Cleveland Clinic, OH (S. Kapadia, S.A., S.E., E.M.T., L.G.S., J.R., J.E., E.H.B.); Stanford University Medical School, CA (D.C.M.); St. Paul's Hospital, University of British Columbia, Vancouver (J.G.W.); Baylor Scott and White Health, Plano, TX (M.M.); Hospital of the University of Pennsylvania, Philadelphia (H.C.H.); MedStar Washington Hospital Center, DC (A.D.P.); Columbia University Medical Center/New York-Presbyterian Hospital (C.R.S., S. Kodali, M.B.L.); Cedars Sinai Medical Center, Los Angeles, CA (R.M.); and Emory University, Atlanta, GA (V.H.T.).
Vinod H
VH
Thourani
From the Cleveland Clinic, OH (S. Kapadia, S.A., S.E., E.M.T., L.G.S., J.R., J.E., E.H.B.); Stanford University Medical School, CA (D.C.M.); St. Paul's Hospital, University of British Columbia, Vancouver (J.G.W.); Baylor Scott and White Health, Plano, TX (M.M.); Hospital of the University of Pennsylvania, Philadelphia (H.C.H.); MedStar Washington Hospital Center, DC (A.D.P.); Columbia University Medical Center/New York-Presbyterian Hospital (C.R.S., S. Kodali, M.B.L.); Cedars Sinai Medical Center, Los Angeles, CA (R.M.); and Emory University, Atlanta, GA (V.H.T.).
Eugene H
EH
Blackstone
From the Cleveland Clinic, OH (S. Kapadia, S.A., S.E., E.M.T., L.G.S., J.R., J.E., E.H.B.); Stanford University Medical School, CA (D.C.M.); St. Paul's Hospital, University of British Columbia, Vancouver (J.G.W.); Baylor Scott and White Health, Plano, TX (M.M.); Hospital of the University of Pennsylvania, Philadelphia (H.C.H.); MedStar Washington Hospital Center, DC (A.D.P.); Columbia University Medical Center/New York-Presbyterian Hospital (C.R.S., S. Kodali, M.B.L.); Cedars Sinai Medical Center, Los Angeles, CA (R.M.); and Emory University, Atlanta, GA (V.H.T.).
Martin B
MB
Leon
D000368:Aged; D000369:Aged, 80 and over; D001022:Aortic Valve Insufficiency / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery*; D006328:Cardiac Catheterization; D005260:Female; D005263:Femoral Artery; D006801:Humans; D015994:Incidence; D002546:Ischemic Attack, Transient / Q000175:diagnosis / Q000453:epidemiology* / Q000401:mortality / Q000628:therapy; D053208:Kaplan-Meier Estimate; D008297:Male; D011677:Punctures; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D020521:Stroke / Q000175:diagnosis / Q000453:epidemiology* / Q000401:mortality / Q000628:therapy; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects* / Q000379:methods / Q000401:mortality; D016896:Treatment Outcome
stroke; transapical; transcatheter aortic valve replacement; transfemoral; transient ischemic attack