There are limited data on the long-term durability of transcatheter aortic valve replacement (TAVR) and surgery for severe aortic stenosis (AS) in patients of all risk levels. Management of patients with AS requires an understanding of bioprosthetic valve durability and failure. Revisit the evidence evaluating the 5-year incidence, outcomes, and predictors of hemodynamic structural valve disease in patients undergoing TAVR and surgery that will support best practices for treatment selection.
Transcatheter Aortic Valve Replacement vs Surgical Aortic Valve Replacement
Aortic stenosis has traditionally been managed as a surgical disease using surgical aortic valve replacement (SAVR). However, many patients who are older or have multiple comorbidities are ineligible for surgery and require alternative options, such as transcatheter aortic valve replacement (TAVR). Data are limited on the incidence and factors associated with structural valve deterioration (SVD) after TAVR and SAVR for severe aortic stenosis in patients of all risk levels. The lifetime management of these patients requires an understanding of long-term bioprosthetic valve durability and failure. In this ECHO, we will 1) compare TAVR and SAVR options; 2) discuss recently presented 5-year durability data on the use of TAVR in high- and intermediate-risk patients; and 3) emphasize the importance of the “Heart Team” approach to provide cooperative and improved care for patients.
Aortic Valve Replacement in Patients With Aortic Stenosis
Patients with calcification or hardening of the valve (resulting in heart failure) may undergo aortic valve replacement via a median sternotomy. Despite the availability of minimally invasive approaches, surgery is a common approach for eligible patients and has a strong track record of improved patient outcomes, as seen in a variety of peer-reviewed publications. Patients who are ineligible for surgery may undergo TAVR, a minimally invasive procedure which is now considered a mainstream approach for aortic stenosis in older, sicker patients. TAVR is performed by making a groin puncture, placing a wire into the heart that is used to guide a catheter to the diseased valve, and then placing the new valve using radial force and friction.
TAVR is an established treatment for severe aortic stenosis in patients of all risk levels, including intermediate- and low-risk patients who are frequently septuagenarians. Younger, low-risk patients with aortic stenosis are being offered TAVR, but the benefits have not yet been proven in this population.
Bioprosthetic Valve Dysfunction in TAVR Compared with SAVR
The Valve Academic Resource Consortium-3 (VARC-3) consensus document provides an update of the most appropriate clinical endpoint definitions for TAVR and SAVR clinical research.1 The VARC-3 defines 4 modes of bioprosthetic valve dysfunction: SVD, non-SVD, thrombosis, and endocarditis. The first stage of bioprosthetic valve dysfunction, SVD, occurs as a result of intrinsic permanent changes to the valve, including wear and tear, leaflet disruption, flail leaflet, leaflet fibrosis and/or calcification, and strut fracture or deformation. SVD is followed by moderate hemodynamic valve deterioration (HVD), severe HVD, and bioprosthetic valve failure.
A recent pooled analysis of the CoreValve US Pivotal and SURTAVI randomized controlled trials (RCTs) was performed to evaluate the 5-year incidence, outcomes, and predictors of SVD.2,3 Results showed that the rate of SVD through 5 years was lower in patients undergoing TAVR with a self-expanding supra-annular valve (either CoreValve or Evolut) versus those undergoing SAVR. High-risk patients were included in the CoreValve US Pivotal trial; intermediate-risk patients were included in the SURTAVI trial. SVD was defined as moderate or severe HVD with an increase in mean gradient ≥10 mm Hg from discharge/30-day echo to last available echo and mean gradient ≥20 mm Hg at last available echo or new onset or increase of moderate or severe intra-prosthetic aortic regurgitation.2
The trial investigators analyzed data from 1,128 patients who underwent TAVR and 971 patients who underwent SAVR in the 2 RCTs to determine the SVD rate at 5 years. In patients with severe aortic stenosis at intermediate or high surgical risk, the 5-year rate of SVD was 2.57% in those undergoing TAVR and 4.38% in those treated with SAVR (Figure 1).2
Figure 1. 5-Year SVD Adjusted for Competing Risk of Mortality
Patients with smaller (≤23 mm) annuli had a greater difference in SVD at 5 years post-procedure (5.86% surgery vs 1.39% TAVR; P = 0.049; Figure 2) than those with larger (>23 mm) annuli (3.96% surgery vs 2.48% TAVR; P = 0.067).2 Overall, patients with smaller annuli (including women) had more accelerated SVD.
Figure 2. 5-Year SVD in Smaller (≤23 mm) Annular Diameter
SVD was associated with an approximately 2-fold increase in risk of all-cause mortality or hospitalization for aortic valve disease or worsening heart failure in the first 5 years following SAVR or TAVR (Figure 3).2 Higher mortality was observed in patients who had early SVD compared with those who did not.2
Figure 3. Clinical Outcomes in Patients Undergoing TAVR and SAVR Who Developed SVD
Heart Team Approach
Figure 4. Collaborative Heart Team Approach
The Heart Team is a team-based, collaborative clinical approach composed of the primary clinical cardiologist, interventional cardiologist, cardiac surgeon, and cardiovascular imager (Figure 4). According to the ACC/AHA Guidelines for the Management of Valvular Heart Disease (VHD), patients with severe VHD should be evaluated by a multidisciplinary heart valve team (MDT) when intervention is considered.4
Early referral is also important, with the ACC/AHA guidelines specifying that consultation with or referral to a primary or comprehensive heart valve center is reasonable when treatment options are being discussed for 1) asymptomatic patients with severe VHD; 2) patients who may benefit from valve repair versus valve replacement; or 3) patients with multiple comorbidities for whom valve intervention is considered.4 Patients with intermediate risk and who are progressing may be referred, and they may qualify more for SAVR than TAVR. Disease progression can be nonlinear, with some patients going from mild to moderate over long periods of time and then moderate to severe very quickly. Circumferential narrowing of the leaflets is often not fully symmetrical and is instead very eccentric.
Monitoring patients who have either received TAVR or SAVR for SVD is essential.4 An early baseline echo post implant is performed, usually within 30 days, then repeated at 3 months, 6 months, and then annually thereafter, provided nothing has clinically changed with the patient. Signs of SVD may include increases in mean transvalvular gradient or issues with prosthetic valve dysfunction in terms of paravalvular leaks, regurgitation, and worsening stenosis.
Shared decision-making is recommended when discussing treatment options with patients who have severe aortic stenosis. Important considerations are the patient’s age, level of frailty, risk of surgery, risk associated with TAVR, durability of the valve, and durability of the patient. Lifetime management of patients with aortic stenosis is required, with important considerations that go beyond TAVR vs SAVR and that are not associated with class effects. Each tissue valve has its own longevity. Findings from the current analysis apply to the self-expanding supra-annular CoreValve and Evolut valves and may not apply to intra-annular valves, balloon expandable valves, or even other self-expanding platforms. Coronary access is a bigger concern with a supra-annular valve than an intra-annular valve.
The latest evidence from the CoreValve US Pivotal and SURTAVI trials evaluating the 5-year incidence, outcomes, and predictors of hemodynamic SVD in patients undergoing supra-annular self-expanding TAVR and surgery will support best practices for treatment selection. Early referral and involvement of the Heart Team are recommended to improve treatment outcomes. Long-term 10-year follow-up will shed more light on optimal treatment approaches for aortic valve replacement.
- VARC-3 WRITING COMMITTEE; Généreux P, Piazza N, Alu MC, et al. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. Eur Heart J. 2021;42(19):1825-1857. doi:10.1093/eurheartj/ehaa799
- Reardon M, et al. 5-year incidence, timing and predictors of structural valve deterioration of transcatheter and surgical aortic bioprostheses: insights from the CoreValve US Pivotal and SURTAVI trials. Presented at ACC 2022.
- American College of Cardiology. Rate of structural valve deterioration lower with TAVR than with SAVR. April 4, 2022. Accessed October 14, 2022. https://www.acc.org/About-ACC/Press-Releases/2022/04/04/12/06/Rate-of-Structural-Valve-Deterioration-Lower-With-TAVR-Than-With-SAVR
- Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021;143(5):e35-e71. doi:10.1161/CIR.0000000000000932
In accordance with the ACCME Standards for Integrity and Independence, Global Learning Collaborative (GLC) requires that individuals in a position to control the content of an educational activity disclose all relevant financial relationships with any ineligible company. GLC mitigates all conflicts of interest to ensure independence, objectivity, balance, and scientific rigor in all its educational programs.
Suzanne J. Baron, MD
Lahey Hospital and Medical Center
Consulting Fees: Abiomed, Biotronik, Boston Scientific Corp, Medtronic, Shockwave, Zoll
Research: Abiomed, Boston Scientific Corp
Jonathan A. Bradlow, MD, FACC
Montefiore Medical Center
No relevant relationships reported
Kendra J. Grubb, MD
Surgical Director, Structural Heart & Valve Center
Consulting Fees: Boston Scientific, Edwards, Medtronic
Research: Edwards Lifesciences, Medtronic
- Cindy Davidson has nothing to disclose.
- Howard Green has nothing to disclose.
- Colleen Resnick has nothing to disclose.
- Mara Siegel has nothing to disclose.
- Mario Trucillo, PhD, has nothing to disclose.
After participating in this educational activity, participants should be better able to:
- Evaluate the role and advantages of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) therapeutic options based on recent lifetime management evidence
- Apply recent evidence on structural valve deterioration to validate the clinical use of TAVR in a variety of patient types
- Assess the value of the collaboration between interventional cardiologists and cardiac surgeons, the “heart team” approach, resulting in cooperative and improved care for patients
This activity is designed to meet the educational needs of cardiologists, cardiovascular surgeons, and interventional cardiologists.
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