What is the durability of transcatheter heart valves and is this similar to surgical bioprostheses?
In this analysis of data from the PARTNER Trial, population hemodynamic trends showed early favorable hemodynamic changes after transcatheter aortic valve replacement implantation, with midterm stability at a median follow-up of 3.1 (maximum, 5) years, and no significant changes in surgical aortic valve replacement. Reintervention and severely abnormal hemodynamics on echocardiograms were infrequent and not associated with excess death in patients after either transcatheter aortic valve replacement or surgical aortic valve replacement.
There is longitudinal durability of both transcatheter and surgical aortic valve replacements, with rare findings of adverse hemodynamics or valve deterioration.
Use of transcatheter aortic valve replacement (TAVR) for severe aortic stenosis is growing rapidly. However, to our knowledge, the durability of these prostheses is incompletely defined.
To determine the midterm hemodynamic performance of balloon-expandable transcatheter heart valves.
Design, Setting, and Participants
In this study, we analyzed core laboratory–generated data from echocardiograms of all patients enrolled in the Placement of Aortic Transcatheter Valves (PARTNER) 1 Trial with successful TAVR or surgical AVR (SAVR) obtained preimplantation and at 7 days, 1 and 6 months, and 1, 2, 3, 4, and 5 years postimplantation. Patients from continued access observational studies were included for comparison.
Successful implantation after randomization to TAVR vs SAVR (PARTNER 1A; TAVR, n = 321; SAVR, n = 313), TAVR vs medical treatment (PARTNER 1B; TAVR, n = 165), and continued access (TAVR, n = 1996). Five-year echocardiogram data were available for 424 patients after TAVR and 49 after SAVR.
Main Outcomes and Measures
Death or reintervention for aortic valve structural indications, measured using aortic valve mean gradient, effective orifice area, Doppler velocity index, and evidence of hemodynamic deterioration by reintervention, adverse hemodynamics, or transvalvular regurgitation.
Of 2795 included patients, the mean (SD) age was 84.5 (7.1) years, and 1313 (47.0%) were female. Population hemodynamic trends derived from nonlinear mixed-effects models showed small early favorable changes in the first few months post-TAVR, with a decrease of −2.9 mm Hg in aortic valve mean gradient, an increase of 0.028 in Doppler velocity index, and an increase of 0.09 cm2 in effective orifice area. There was relative stability at a median follow-up of 3.1 (maximum, 5) years. Moderate/severe transvalvular regurgitation was noted in 89 patients (3.7%) after TAVR and increased over time. Patients with SAVR showed no significant changes. In TAVR, death/reintervention was associated with lower ejection fraction, stroke volume index, and aortic valve mean gradient up to 3 years, with no association with Doppler velocity index or valve area. Reintervention occurred in 20 patients (0.8%) after TAVR and in 1 (0.3%) after SAVR and became less frequent over time. Reintervention was caused by structural deterioration of transcatheter heart valves in only 5 patients. Severely abnormal hemodynamics on echocardiograms were also infrequent and not associated with excess death or reintervention for either TAVR or SAVR.
Conclusions and Relevance
This large, core laboratory–based study of transcatheter heart valves revealed excellent durability of the transcatheter heart valves and SAVR. Abnormal findings in individual patients, suggestive of valve thrombosis or structural deterioration, were rare in this protocol-driven database and require further investigation.
clinicaltrials.gov Identifier: NCT00530894
Douglas PS, Leon MB, Mack MJ, Svensson LG, Webb JG, Hahn RT, Pibarot P, Weissman NJ, Miller DC, Kapadia S, Herrmann HC, Kodali SK, Makkar RR, Thourani VH, Lerakis S, Lowry AM, Rajeswaran J, Finn MT, Alu MC, Smith CR, Blackstone EH, for the PARTNER Trial Investigators. Longitudinal Hemodynamics of Transcatheter and Surgical Aortic Valves in the PARTNER Trial. JAMA Cardiol. Published online September 27, 2017. doi:10.1001/jamacardio.2017.3306
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