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Original Investigation
June 18, 2019

Association Between Transcatheter Aortic Valve Replacement and Early Postprocedural Stroke

Author Affiliations
  • 1Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio
  • 2Department of Cardiac Surgery, Heart and Vascular Institute, Cleveland Clinic, Ohio
  • 3Department of Cardiology, DeBakey Heart and Vascular Center, Houston Methodist Hospital, Houston, Texas
  • 4Division of Cardiology, Department of Medicine,University of Colorado Hospital, Denver
  • 5Department of Cardiac Surgery, Medstar Heart and Vascular Institute and Georgetown University School of Medicine, Washington, DC
  • 6Department of Medicine, Columbia University Medical Center, New York Presbyterian Hospital, New York
  • 7Duke University Clinical Research Institute, Duke Medical Center, Durham, North Carolina
JAMA. 2019;321(23):2306-2315. doi:10.1001/jama.2019.7525
Key Points

Question  What were the trends for early postprocedural stroke in the first 5 years of transcatheter aortic valve replacement (TAVR) use in the United States?

Findings  In this retrospective cohort study based on a US registry of 101 430 patients who underwent TAVR from November 9, 2011 through May 31, 2017, the rate of 30-day postprocedure stroke was 2.3%. This rate did not change significantly over these years.

Meaning  The rate of 30-day stroke was stable over the first 5 years of TAVR recorded in a US clinical registry.

Abstract

Importance  Reducing postprocedural stroke is important to improve the safety of transcatheter aortic valve replacement (TAVR).

Objective  This study evaluated the trends of stroke occurring within 30 days after the procedure during the first 5 years TAVR was used in the United States, the association of stroke with 30-day mortality, and the association of medical therapy with 30-day stroke risk.

Design, Setting, and Participants  Retrospective cohort study including 101 430 patients who were treated with femoral and nonfemoral TAVR at 521 US hospitals in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry from November 9, 2011, through May 31, 2017. Thirty-day follow-up ended June 30, 2017.

Exposures  TAVR.

Main Outcomes and Measures  The rates of 30-day transient ischemic attack and stroke were assessed. Association of stroke with 30-day mortality and association of antithrombotic medical therapies with postdischarge 30-day stroke were assessed with a Cox proportional hazards model and propensity-score matching, respectively.

Results  Among 101 430 patients included in the study (median age, 83 years [interquartile range {IQR}, 76-87 years]; 47 797 women [47.1%]; and 85 147 patients [83.9%] treated via femoral access), 30-day postprocedure follow-up data was assessed in all patients. At day 30, there were 2290 patients (2.3%) with a stroke of any kind (95% CI, 2.2%-2.4%), and 373 patients (0.4%) with transient ischemic attacks (95% CI, 0.3%-0.4%) . During the study period, 30-day stroke rates were stable without an increasing or decreasing trend in all patients (P for trend = .22) and in the large femoral access subgroup (P trend = .47). Among cases of stroke within 30 days, 1119 strokes (48.9%) occurred within the first day and 1567 (68.4%) within 3 days following TAVR. The occurrence of stroke was associated with a significant increase in 30-day mortality: 383 patients (16.7%) of 2290 who had a stroke vs 3662 patients (3.7%) of 99 140 who did not have a stroke died (P < .001; risk-adjusted hazard ratio [HR], 6.1 [95% CI, 5.4-6.8]; P < .001). After propensity-score matching, 30-day stroke risk was not associated with whether patients in the femoral cohort were (0.55%) or were not (0.52%) treated with dual antiplatelet therapy at hospital discharge (HR, 1.04; 95% CI, 0.74-1.46) nor was it associated with whether patients in the nonfemoral cohort were (0.71%) or were not (0.69%) treated with dual antiplatelet therapy (HR, 1.02; 95% CI, 0.54-1.95). Similarly, 30-day stroke risk was not associated with whether patients in the femoral cohort were (0.57%) or were not (0.55) treated with oral anticoagulant therapy at hospital discharge (HR, 1.03; 95% CI, 0.73-1.46) nor was it associated with whether patients in the nonfemoral cohort were (0.75%) or were not (0.82%) treated with an oral anticoagulant (HR, 0.93; 95% CI, 0.47-1.83).

Conclusions and Relevance  Between 2011 and 2017, the rate of 30-day stroke following transcatheter aortic valve replacement in a US registry population remained stable.

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