Author + information
- Received November 28, 2017
- Revision received February 20, 2018
- Accepted February 22, 2018
- Published online June 18, 2018.
- Suzanne J. Baron, MD, MSc∗ (, )
- Vinod H. Thourani, MD,
- Susheel Kodali, MD,
- Suzanne V. Arnold, MD, MHA,
- Kaijun Wang, PhD,
- Elizabeth A. Magnuson, ScD,
- Augusto D. Pichard, MD,
- Vasilis Babaliaros, MD,
- Isaac George, MD,
- D. Craig Miller, MD,
- E. Murat Tuzcu, MD,
- Kevin Greason, MD,
- Howard C. Herrmann, MD,
- Craig R. Smith, MD,
- Martin B. Leon, MD,
- David J. Cohen, MD, MSc,
- on behalf of the PARTNER 2 Investigators
- ↵∗Address for correspondence:
Dr. Suzanne J. Baron, Saint Luke’s Mid America Heart Institute, University of Missouri–Kansas City School of Medicine, 20 NE Saint Luke’s Boulevard, Suite 240, Lees Summit, Missouri 64086.
Objectives The aim of this study was to evaluate whether transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve (S3-TAVR) results in improved quality of life (QoL) compared with previous-generation TAVR devices or surgical aortic valve replacement (SAVR).
Background In patients with severe aortic stenosis at intermediate surgical risk, TAVR using the SAPIEN XT valve (XT-TAVR) results in similar QoL compared with SAVR. Compared with SAPIEN XT, the SAPIEN 3 valve offers a lower delivery profile and modifications to reduce paravalvular regurgitation.
Methods Between February and December 2014, 1,078 patients at intermediate surgical risk with severe aortic stenosis were treated with S3-TAVR in the PARTNER S3i (Placement of Aortic Transcatheter Valve) trial. QoL was assessed at baseline, 1 month, and 1 year using the Kansas City Cardiomyopathy Questionnaire, Medical Outcomes Study Short Form-36, and EQ-5D. QoL outcomes of S3-TAVR patients were compared with those in the SAVR and XT-TAVR arms of the PARTNER 2A trial using propensity score stratification to adjust for differences between the treatment groups.
Results Over 1 year, S3-TAVR was associated with substantial improvements in QoL compared with baseline. At 1 month, S3-TAVR was associated with better QoL than either SAVR or XT-TAVR (adjusted differences in Kansas City Cardiomyopathy Questionnaire overall summary score 15.6 and 3.7 points, respectively; p < 0.001). At 1 year, the differences in QoL between S3-TAVR and both SAVR and XT-TAVR were reduced but remained statistically significant (adjusted differences 2.0 and 2.2 points, respectively; p < 0.05). Similar results were seen for generic QoL outcomes.
Conclusions Among patients at intermediate surgical risk with severe aortic stenosis, S3-TAVR resulted in improved QoL at both 1 month and 1 year compared with both XT-TAVR and SAVR.
The PARTNER 2 clinical trial (NCT01314313) and quality-of-life substudy were funded by a research grant from Edwards Lifesciences. 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; and travel reimbursement from Medtronic. Dr. Thourani has received research grants and personal fees from Edwards Lifesciences, Medtronic, St. Jude Medical, Sorin Medical, Boston Scientific, Abbott Vascular and Direct Flow Medical. Dr. Kodali holds equity in Thubrikar Aortic Valve Inc., Dura Biotech, BioTrace Medical, and Microinterventional Devices; has received research grant support from Edwards Lifesciences and St. Jude Medical; is a consultant for Claret Medical, Merrill Lifesciences, BioTrace Medical, Microinterventional Devices; is on the advisory board for Dura Biotech, Abbott Vascular, and Thubrikar Aortic Valve, Inc.; and has received honorarium from Claret Medical, Dura Biotech, and Abbott Vascular. Dr. Pichard has received consulting income from Edwards Lifesciences. Dr. Babaliaros has received research grants and consulting fees from Edwards Lifesciences, Medtronic, St. Jude Medical, Boston Scientific, Direct Flow Medical, and Abbott Vascular. Dr. George has received consulting income from Edwards Lifesciences and Medtronic. Dr. Miller has received consulting income from Abbott Vascular, St. Jude Medical, and Medtronic. Dr. Herrmann has received research grant support from Abbott Vascular, Bayer, Edwards Lifesciences, Boston Scientific, Medtronic, and St. Jude Medical; and consulting income from Edwards Lifesciences. Dr. Cohen has received research grant support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott Vascular; and consulting income from Edwards Lifesciences and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received November 28, 2017.
- Revision received February 20, 2018.
- Accepted February 22, 2018.
- 2018 American College of Cardiology Foundation
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