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Randomized Controlled Trial
. 2017 Nov 1;2(11):1197-1206.
doi: 10.1001/jamacardio.2017.3306.

Longitudinal Hemodynamics of Transcatheter and Surgical Aortic Valves in the PARTNER Trial

Pamela S Douglas  1 , Martin B Leon  2 , Michael J Mack  3 , Lars G Svensson  4 , John G Webb  5 , Rebecca T Hahn  2 , Philippe Pibarot  6 , Neil J Weissman  7 , D Craig Miller  8 , Samir Kapadia  4 , Howard C Herrmann  9 , Susheel K Kodali  2 , Raj R Makkar  10 , Vinod H Thourani  11 , Stamatios Lerakis  11 , Ashley M Lowry  4 , Jeevanantham Rajeswaran  4 , Matthew T Finn  2 , Maria C Alu  2 , Craig R Smith  2 , Eugene H Blackstone  4 ; PARTNER Trial Investigators
Affiliations
Randomized Controlled Trial

Longitudinal Hemodynamics of Transcatheter and Surgical Aortic Valves in the PARTNER Trial

Pamela S Douglas et al. JAMA Cardiol. .

Abstract

Importance: 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.

Objective: 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.

Interventions: 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.

Results: 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.

Trial registration: clinicaltrials.gov Identifier: NCT00530894.

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Conflict of interest statement

Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Douglas leads the PARTNER 1 echocardiography core laboratory. Drs Leon and Svensson are members of the PARTNER Trial Executive Committee, and Dr Svensson has ownership interest in Cardiosolutions and Valveexchange and receives royalties from Posthorax. Dr Hahn receives speaker honoraria from Boston Scientific and Abbott Structural and consults with Abbott Structural. Dr Herrmann has received research funding from Edwards Lifesciences, Medtronic, St Jude, Boston Scientific, and Abbott Vascular and is a consultant for Edwards Lifesciences. Dr Kodali consults with Edwards Lifesciences and Medtronic and has ownership interest in Thubrikar Aortic Valve. Dr Blackstone leads the Cleveland Clinic PARTNER Publications Office, which carries out independent analyses stemming from the PARTNER Trial. Dr Pibarot has a research contract with Edwards Lifesciences for echocardiogram core laboratory analyses but does not receive any personal compensation. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. STROBE Flowchart Showing Patient Flow
SAVR indicates surgical aortic valve replacement; TAVR, transcatheter aortic valve replacement. aSD: 45 days.
Figure 2.
Figure 2.. Temporal Trends in Transcatheter Aortic Valve Replacement
Solid lines indicate the parametric estimate of the temporal trend after procedure; dotted lines indicate 95% CIs. Filled circles indicate grouped data without regard to the repeated measurements based on time intervals, provided here as a crude verification of the model fit. DVI indicates Doppler velocity index.
See this image and copyright information in PMC

Comment in

References

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    1. Kapadia SR, Leon MB, Makkar RR, et al. ; PARTNER Trial Investigators . 5-year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet. 2015;385(9986):2485-2491. - PubMed
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