Author + information
- Received June 20, 2018
- Revision received November 5, 2018
- Accepted November 9, 2018
- Published online February 18, 2019.
- Suzanne V. Arnold, MD, MHAa,∗ (, )
- Yiran Zhang, MSb,
- Suzanne J. Baron, MD, MSca,
- Thomas C. McAndrew, PhDb,
- Maria C. Alu, MSb,
- Susheel K. Kodali, MDb,
- Samir Kapadia, MDc,
- Vinod H. Thourani, MDd,
- D. Craig Miller, MDe,
- Michael J. Mack, MDf,
- Martin B. Leon, MDb and
- David J. Cohen, MD, MSca
- aSaint Luke’s Mid America Heart Institute and University of Missouri–Kansas City, Kansas City, Missouri
- bColumbia-Presbyterian Hospital, New York, New York
- cCleveland Clinic Foundation, Cleveland, Ohio
- dMedstar Washington Hospital Center/Georgetown University, Washington, District of Columbia
- eStanford University Medical School, Stanford, California
- fBaylor Scott and White Health, Plano, Texas
- ↵∗Address for correspondence:
Dr. Suzanne V. Arnold, Saint Luke’s Mid America Heart Institute, 4401 Wornall Road, Kansas City, Missouri 64111.
Objectives The aim of this study was to examine the independent association of short-term complications of transcatheter aortic valve replacement (TAVR) with survival and quality of life at 1 year.
Background Prior studies have examined the mortality and cost implications of various complications of TAVR. However, many of these complications may primarily affect patients’ quality of life after TAVR, which has not been previously studied.
Methods Among patients at intermediate or high surgical risk who underwent TAVR as part of the PARTNER (Placement of Aortic Transcatheter Valve) 2 studies and survived 30 days, the association between complications within the 30 days after TAVR and mortality and quality of life at 1 year was examined. Quality of life was assessed using the Kansas City Cardiomyopathy Questionnaire and the Short-Form 12. Complications assessed included major and minor stroke, life-threatening and major bleeding, vascular injury, stage 3 acute kidney injury, new pacemaker implantation, and mild and moderate or severe paravalvular leak (PVL). Multivariable models that included all complications as well as baseline clinical factors were used to examine the independent association of each complication with outcomes.
Results Among 3,763 TAVR patients, major stroke and stage 3 acute kidney injury were associated with markedly increased risk for 1-year mortality, with adjusted hazard ratios of 5.4 (95% confidence interval [CI]: 3.1 to 9.5) and 4.9 (95% CI: 2.7 to 8.8), respectively, as well as poorer quality of life among survivors (reductions in 1-year Kansas City Cardiomyopathy Questionnaire overall summary score of 15.1 points [95% CI: 24.8 to 5.3 points] and 14.7 points [95% CI: 25.6 to 3.8 points], respectively). Moderate or severe PVL, life-threatening bleeding, and major bleeding were each associated with a more modest increase in mortality and decrement in quality of life, whereas mild PVL was associated with a small decrease in quality of life. After adjusting for baseline characteristics and other complications, need for a new pacemaker, minor stroke, and vascular injury were not independently associated with poor outcomes.
Conclusions Among patients undergoing TAVR, similar events are associated with increased mortality and impaired quality of life at 1 year. These results suggest that despite considerable progress, efforts to further reduce stroke, acute kidney injury, bleeding, and moderate or severe PVL are likely to yield important clinical benefits and remain key targets for device iteration and procedural improvement.
The PARTNER trial was sponsored by Edwards Lifesciences. The present study was self-funded, and the funding organization for the trial did not play a role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; or preparation, review, or approval of the manuscript. Dr. Arnold is supported by a Career Development Grant Award (K23 HL116799) from the National Heart, Lung, and Blood Institute. Dr. Baron has received consulting income from Edwards Lifesciences and St. Jude Medical. Dr. Kodali has received consulting income from Edwards Lifesciences and Medtronic; and is an advisory board member for Thubrikar Aortic Valve, Paieon Medical, and St. Jude Medical. Dr. Thourani has served as an adviser for Edwards Lifesciences, Abbott Vascular, Boston Scientific, and Gore Vascular. Drs. Mack and Leon have received travel reimbursements from Edwards Lifesciences for activities related to their positions on the executive committee of the PARTNER trial. Dr. Cohen has received research grant support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott Vascular; and has received consulting fees from Medtronic and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received June 20, 2018.
- Revision received November 5, 2018.
- Accepted November 9, 2018.
- 2019 American College of Cardiology Foundation
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