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Association Between Transcatheter Aortic Valve Replacement and Early Postprocedural Stroke

Educational Objective
To understand the benefits and risks of transcatheter aortic valve replacement.
1 Credit CME
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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Article Information

Corresponding Author: Samir R. Kapadia, MD, Cleveland Clinic Lerner College of Medicine, Cardiac Catheterization Laboratory, Aortic Valve Center, Cleveland Clinic, 9500 Euclid Ave, J2-3, Cleveland, OH 44195 (kapadis@ccf.org).

Accepted for Publication: May 16, 2019.

Author Contributions: Drs Huded and Kapadia had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Huded, Kleiman, Thourani, Vemulapalli, Kapadia.

Acquisition, analysis, or interpretation of data: Huded, Tuzcu, Krishnaswamy, Mick, Svensson, Carroll, Thourani, Kirtane, Manandhar, Kosinski, Vemulapalli.

Drafting of the manuscript: Huded, Thourani, Kapadia.

Critical revision of the manuscript for important intellectual content: Huded, Tuzcu, Krishnaswamy, Mick, Kleiman, Svensson, Carroll, Kirtane, Manandhar, Kosinski, Vemulapalli, Kapadia.

Statistical analysis: Huded, Manandhar, Kosinski.

Obtained funding: Huded.

Administrative, technical, or material support: Huded, Svensson, Vemulapalli, Kapadia.

Supervision: Huded, Tuzcu, Krishnaswamy, Mick, Kleiman, Thourani, Vemulapalli, Kapadia.

Conflict of Interest Disclosures: Dr Kleiman reports receiving funding for clinical trials and educational support from Medtronic. Dr Svensson reports receiving grants from the Cleveland Clinic during the conduct of the study and that he is an unpaid member of the executive committee of the PARTNER Trial and chairman of the PARTNER publications committee. Dr Carroll reports serving as a clinical trial investigator for Medtronic and Edwards Lifesciences. Dr Thourani reports receiving grants and personal fees from Edwards Lifesciences and grants from Medtronic during the conduct of the study. Dr Kirtane reports receiving institutional funding to Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, and ReCor Medical. Dr Vemulapalli reports receiving grants from the American College of Cardiology, Society of Thoracic Surgeons, Abbott Vascular, and Patient Centered Outcomes Research Institute; grants and personal fees from Boston Scientific; personal fees from Janssen, and grants from Institutes outside the submitted work. No other disclosures were reported.

Funding/Support: This project was funded by the ACC National Cardiovascular Data Registry and the STS. The STS/ACC TVT Registry is an initiative of the STS and ACC Foundation.

Role of the Funder/Sponsor: The funding organizations had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

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