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Circ Cardiovasc Interv. 2016 Sep;9(9). pii: e002981. doi: 10.1161/CIRCINTERVENTIONS.115.002981.

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).

Author information

1
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.
2
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.).

Abstract

BACKGROUND:

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.

METHODS AND RESULTS:

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.

CONCLUSIONS:

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.

CLINICAL TRIAL REGISTRATION:

URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.

KEYWORDS:

stroke; transapical; transcatheter aortic valve replacement; transfemoral; transient ischemic attack

[Indexed for MEDLINE]

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