Author + information
- Received April 14, 2016
- Revision received October 31, 2016
- Accepted November 3, 2016
- Published online January 2, 2017.
- Melissa A. Daubert, MDa,∗ (, )
- Neil J. Weissman, MDb,
- Rebecca T. Hahn, MDc,
- Philippe Pibarot, DVM, PhDd,
- Rupa Parvataneni, MSe,
- Michael J. Mack, MDf,
- Lars G. Svensson, MD, PhDg,
- Deepika Gopal, MDf,
- Samir Kapadia, MDg,
- Robert J. Siegel, MDh,
- Susheel K. Kodali, MDc,
- Wilson Y. Szeto, MDi,
- Raj Makkar, MDh,
- Martin B. Leon, MDc and
- Pamela S. Douglas, MDa
- aDuke University Medical Center, Duke Clinical Research Institute, Durham, North Carolina
- bMedStar Health Research Institute, Washington, DC
- cColumbia University Medical Center, New York, New York
- dQuebec Heart and Lung Institute, Quebec, Ontario, Canada
- eCardiovascular Research Foundation, New York, New York
- fBaylor Scott & White Healthcare, Plano, Texas
- gCleveland Clinic, Cleveland, Ohio
- hCedars-Sinai Medical Center, Los Angeles, California
- iUniversity of Pennsylvania Medical Center, Philadelphia, Pennsylvania
- ↵∗Reprint requests and correspondence:
Dr. Melissa A. Daubert, Duke University Medical Center, Duke Clinical Research Institute, 2400 Pratt Street, Room 0311 Terrace Level, Durham, North Carolina 27705.
Objectives The aim of this study was to evaluate the long-term performance of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) through longitudinal echocardiographic analysis.
Background The long-term performance of the SAPIEN TAVR is not well-described. Therefore, we examined the hemodynamic and valvular profile of the SAPIEN TAVR over 5 years.
Methods All patients receiving TAVR or SAVR with first post-implant (FPI) and 5-year echoes were analyzed for aortic valve (AV) peak velocity, AV mean gradient, AV area, peak left ventricular (LV) outflow tract and in-stent velocities, Doppler velocity index, aortic regurgitation (AR), LV mass index, stroke volume index, and cardiac index. The FPI and 5-year data were compared using a paired t test or McNemar’s analyses.
Results There were 86 TAVR and 48 SAVR patients with paired FPI and 5-year echocardiograms. Baseline characteristics were similar between groups. The AV area did not change significantly 5 years after TAVR (p = 0.35). The AV mean gradient also remained stable: 11.5 ± 5.4 mm Hg at FPI to 11.0 ± 6.3 mm Hg at 5 years (p = 0.41). In contrast, the peak AV and LV outflow tract velocities decreased (p = 0.03 and p = 0.008, respectively), as did in-stent velocity (p = 0.015). Correspondingly, the TAVR Doppler velocity index was unchanged (p = 0.07). Among TAVR patients, there was no change in total AR (p = 0.40), transvalvular AR (p = 0.37), or paravalvular AR (p = 0.26). Stroke volume index and cardiac index remained stable (p = 0.16 and p = 0.25, respectively). However, there was a significant regression of LV mass index (p < 0.0001). The longitudinal evaluation among SAVR patients revealed similar trends. There was a low rate of adverse events among TAVR and SAVR patients alive at 5 years.
Conclusions Longitudinal assessment of the PARTNER (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial) I trial demonstrates that valve performance and cardiac hemodynamics are stable after implantation in both SAPIEN TAVR and SAVR in patients alive at 5 years. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial [PARTNER]; NCT00530894)
The PARTNER Trial was funded by Edwards Lifesciences.
Duke Clinical Research Institute and Columbia University Medical Center were the recipients of research grants from Edwards Lifesciences, Inc. Dr. Weissman has received grants from Edwards Lifesciences, Abbott Vascular, Medtronic, Sorin, Direct Flow Medical, Boston Scientific, and JenaValve. Dr. Hahn has received consultant fees from Edwards Lifesciences; and research support from Philips Healthcare. Dr. Pibarot holds the Canada research Chair in Valvular Heart Diseases, Canadian Institutes of Health Research, Ottawa, Ontario, Canada; and has received grant support from Edwards Lifesciences. Dr. Svensson holds equity in Cardiosolution and Valvexchange; and intellectual property with Postthorax. Dr. Kodali has received grants from Edwards Lifesciences and Medtronic; is a member of the PARTNER Trial Executive Committee; and holds equity in Thubrikar Aortic Valve, Inc. Dr. Szeto has received consulting fees/honoraria from Microinterventional Devices. Dr. Makkar has received grants from Edwards Lifesciences and St. Jude Medical; is a consultant for Abbott Vascular, Cordis, and Medtronic; and holds equity in Entourage Medical. Drs. Mack, Svensson, and Leon have received travel reimbursements from Edwards Lifesciences related to their work as unpaid members of the PARTNER Trial Executive Committee. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received April 14, 2016.
- Revision received October 31, 2016.
- Accepted November 3, 2016.
- American College of Cardiology Foundation