Abstract and Introduction
Graphical Abstract: Decision-making process between TAVI and SAVR. Refer to Figures 2, 4, and 6 for details of the valve morphology category. Refer to Figure 3 for details on the femoral access category. Refer to Figure 7 for more details on concomitant valve disease. Refer to Figure 8 for more details on coronary artery disease. AR, aortic regurgitation; MR, mitral regurgitation; TR, tricuspid regurgitation; MS, mitral stenosis; LM, left main; SAVR, surgical aortic valve replacement; TAVI, transcatheter aortic valve implantation.
Transcatheter aortic valve implantation (TAVI) has matured into a standard treatment option for patients with severe symptomatic aortic valve stenosis (AS) across the whole spectrum of risk. The advances in the interventional treatment of AS raise the question of which patients with severe AS should be referred to surgery. The myriad of clinical permutations does not allow providing a single, uniform treatment strategy. Rather, the advent of TAVI along with established surgical aortic valve replacement (SAVR) fundamentally enforces the role of the multidisciplinary heart team for decision-making recommending the best individual choice of the two options based on a thorough review of clinical and anatomical factors as well as lifetime management considerations. Involvement of the informed patient expressing treatment preferences is a key for a shared decision-making process. Herein, we provide an in-depth review of evidence informing the decision-making process between TAVI and SAVR and key elements for treatment selection. Special attention is given to the populations that have been excluded from randomized clinical trials, and also lifetime management strategies of patients with severe AS are proposed.
Transcatheter aortic valve implantation (TAVI) has been directly compared with surgical aortic valve replacement (SAVR) in a series of randomized clinical trials across the entire spectrum of surgical risk.[1–7] Across these trials, TAVI has consistently been associated with clinical outcomes better or comparable to SAVR in terms of all-cause death and stroke throughout longest available follow-up (Figure 1, see Supplementary material online, Table S1).[8–11] In a meta-analysis including seven landmark trials, TAVI was associated with a modest reduction in all-cause death and stroke throughout 2 years irrespective of surgical risk and type of transcatheter heart valve (THV) system, a difference that was apparent in patients allocated to transfemoral TAVI. These excellent outcomes, albeit still mid-term, have led to a paradigm shift in the management of patients with severe aortic valve stenosis (AS) by establishing a less-invasive treatment that allows for more rapid recovery while providing similar clinical benefits as the previous gold standard SAVR.
Short- and long-term outcomes of major randomized clinical trials. The results of PARTNER 1A, PARTNER 2A, PARTNER 2B, PARTNER 3, SURTAVI, and PARTNER 3 are provided from intention-to-treat analyses. The results of U.S. CoreValve High risk, NOTION, and Evolut Low Risk are provided from as-treated analyses. #1: Results are provided with differences (transcatheter aortic valve implantation–surgical aortic valve replacement) and 95% Bayesian credible interval. #2: Results are provided with hazard ratios and 95% confidence intervals. #3: Any stoke.
As a result, current European and US guidelines for the management of valvular heart disease consider transfemoral TAVI and SAVR both Class I recommendations for the majority of patients with severe, symptomatic AS (Table 1).[13,14] The decision is usually made by local heart teams taking into consideration multiple and complex clinical and anatomical factors (Graphical Abstract).
The available body of evidence supporting TAVI compared with SAVR was obtained in carefully selected patient populations, whereas the relative safety and efficacy remain less well defined in populations excluded from the landmark trials (Table 2).[1–7] Moreover, there remain uncertainties related to long-term durability with both TAVI and SAVR and the optimal lifetime management of patients with severe AS. In this article, we will discuss which patients with severe AS should be referred to surgery following the recent update of guideline recommendations. We focus on the factors that increase the risk or lead to suboptimal outcomes with TAVI as well as patient populations that have been excluded from the randomized trials, and we propose potential strategies for the lifetime management of patients with severe AS. As outlined in the current guidelines on valvular heart disease, these patients require a comprehensive patient-centred evaluation based on the sound clinical assessment as well as careful integrated imaging with transthoracic echocardiography providing the most important baseline qualitative and quantitative information supplemented by transesophageal echocardiography, cardiac computed tomography (CT), cardiac magnetic resonance, and stress testing as needed and final synthesis in terms of treatment allocation by the heart team.[13,14]
Eur Heart J. 2022;43(29):2729-2750. © 2022 Oxford University Press
Copyright 2007 European Society of Cardiology. Published by Oxford University Press. All rights reserved.