Structural Deterioration of Transcatheter Versus Surgical Aortic Valve Bioprostheses in the PARTNER-2 Trial
Why the study?
It was unknown whether transcatheter valves have similar durability to surgical bioprosthetic valves, and traditional definitions based on reintervention or death underestimate SVD.
Does transcatheter aortic valve replacement (TAVR) prevent structural valve deterioration compared to surgical aortic valve replacement (SAVR) in intermediate-risk patients with severe aortic stenosis?
Structured PICO
Does transcatheter aortic valve replacement (TAVR) prevent structural valve deterioration compared to surgical aortic valve replacement (SAVR) in intermediate-risk patients with severe aortic stenosis?
P
Population
Intermediate-risk patients with severe aortic stenosis
I
Intervention
Transcatheter aortic valve replacement (TAVR) with the SAPIEN XT or SAPIEN 3 valve
C
Comparator
Surgical aortic valve replacement (SAVR)
O
Outcome
Incidence of structural valve deterioration (SVD), defined as the composite of SVD-related hemodynamic valve deterioration during echocardiographic follow-up and/or SVD-related bioprosthetic valve failure (BVF) at 5 yearscomposite
The third-generation SAPIEN 3 transcatheter valve demonstrates similar 5-year structural durability to surgical valves, unlike the older SAPIEN XT which had higher rates of deterioration.
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Durability is the last Achilles' heel, or the last unknown, for TAVR. We just got the results from the two latest trials in low-risk patients, which are encouraging, but on the other hand you think, 'OK, but this is only 1 year.' When we're dealing with low-risk patients, you need to think 10 years from now. So, based on these results, we may need to careful with low-risk patients who are younger. When you're younger than 65 years, maybe do surgery? SAVR is still a great operation when it's well done and there is an established record for durability.”
“Everybody is waiting for good data about durability.”
“There's something in it for everyone, I think the surgeons can take some confidence that at least in [PARTNER 3] compared to [PARTNER 2], they've really upped their game and put in larger valves and the surgical results are excellent. And we can be confident about TAVR being a very good therapy in low-to-intermediate-risk patients. Sometimes we get carried away about TAVR, TAVR, TAVR, but I think we have to give credit to the surgeons for doing a really good job.”
Implication
Warrants caution expanding TAVR to younger lower-risk patients; leaves open long-term durability versus SAVR.
Abstract
BACKGROUND It is unknown whether transcatheter valves will have similar durability as surgical bioprosthetic valves. Definitions of structural valve deterioration (SVD), based on valve related reintervention or death, underestimate the incidence of SVD. OBJECTIVES This study sought to determine and compare the 5-year incidence of SVD, using new standardized definitions based on echocardiographic follow-up of valve function, in intermediate-risk patients with severe aortic stenosis given transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) in the PARTNER (Placement of Aortic Transcatheter Valves) 2A trial and registry. METHODS In the PARTNER 2A trial, patients were randomly assigned to receive either TAVR with the SAPIEN XT or SAVR, whereas in the SAPIEN 3 registry, patients were assigned to TAVR with the SAPIEN 3. The primary endpoint was the incidence of SVD, that is, the composite of SVD-related hemodynamic valve deterioration during echocardiographic follow-up and/or SVD-related bioprosthetic valve failure (BVF) at 5 years. RESULTS Compared with SAVR, the SAPIEN-XT TAVR cohort had a significantly higher 5-year exposure adjusted incidence rates (per 100 patient-years) of SVD (1.61 ± 0.24% vs. 0.63 ± 0.16%), SVD-related BVF (0.58 ± 0.14% vs. 0.12 ± 0.07%), and all-cause (structural or nonstructural) BVF (0.81 ± 0.16% vs. 0.27 ± 0.10%) (p ≤ 0.01 for all). The 5-year rates of SVD (0.68 ± 0.18% vs. 0.60 ± 0.17%; p = 0.71), SVD-related BVF (0.29 ± 0.12% vs. 0.14 ± 0.08%; p = 0.25), and all-cause BVF (0.60 ± 0.15% vs. 0.32 ± 0.11%; p = 0.32) in SAPIEN 3 TAVR were not significantly different to a propensity score matched SAVR cohort. The 5-year rates of SVD and SVD-related BVF were significantly lower in SAPIEN 3 versus SAPIEN XT TAVR matched cohorts. CONCLUSIONS Compared with SAVR, the second-generation SAPIEN XT balloon-expandable valve has a higher 5-year rate of SVD, whereas the third-generation SAPIEN 3 has a rate of SVD that was not different from SAVR. (The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII A [PARTNERII A]; NCT01314313; The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - PARTNER II - PARTNERII - S3 Intermediate [PARTNERII S3i]; NCT03222128).
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Cite This Study
Pîbarot et al. (2020) studied this question.