Jessica G.Y. Luc MD LLM, Busra Cangut MD MS, Clauden Louis MD MS MPH, Michel Pompeu Sá MD MSc PhD, Albert W. Chan MD MSc, Jahangir Charania MD, Daniel R. Wong MD MPH, Timothy B. Latham MD
Lankenau Medical Center, Main Line Health
Icahn School of Medicine
Winter Haven Hospital, BayCare Medical Group
Massachusetts General Hospital
Brigham and Women’s Hospital
Royal Columbian Hospital, University of British Columbia
July 30, 2024
Abbreviations & Definitions
ACC/AHA – American College of Cardiology/American Heart Association
AR – Aortic regurgitation
AS – Aortic stenosis
AU – Agatston unit
AVA – Aortic valve area
AVAi – Aortic valve area index
BSA – Body surface area
CCS – Canadian Cardiovascular Society
CCTA – Coronary computed tomography angiography
DSE – Dobutamine stress echo
DVI – Doppler velocity index
ERO – Effective regurgitant orifice
ESC/EACTS – European Society of Cardiology/European Association for Cardio-Thoracic Surgery
EST – Exercise stress test
EuroSCORE II – European System for Cardiac Operative Risk Evaluation
LFLG – Low flow low gradient
LVEF – Left ventricular ejection fraction
LVESD – Left ventricular end systolic diameter
LVH – Left ventricular hypertrophy
LVOT – Left ventricular outflow tract
MG – Mean gradient
PAH – Pulmonary arterial hypertension
PHT – Pressure half time
SAVR – Surgical aortic valve replacement
STS PROM – Society of Thoracic Surgeons Predicted Risk of Mortality
SVi – Stroke volume index
TAVR – Transcatheter aortic valve replacement
VARC – Valve Academic Research Consortium
Vmax – Maximum aortic valve velocity
Indications & Guidelines for Management by Grade/Stage of Disease
The indications and guidelines for the management of aortic valve disease are provided by the 2020 ACC/AHA guidelines for the management of patients with valvular heart disease.1 The following chapter will focus on the 2020 ACC/AHA valve guidelines with a discussion on TAVR vs. SAVR, as well as valve-in-valve interventions. In addition, a comparison of the 2020 ACC/AHA valve guidelines with the 2021 ESC/EACTS valve guidelines2 will be offered as a supplement. Management of aortic stenosis (AS) and aortic regurgitation (AR) has been previously discussed in other chapters.
Both the 2020 ACC/AHA1 and the 2021 ESC/EACTS valve guidelines2 provide recommendations on certain patient criteria, such as age, comorbidities, operative risk score, valve or vascular anatomy, stage of valvular disease, and others that would favor either SAVR or TAVR. Notably, SAVR is favored in patients with asymptomatic severe or moderate AS, severe AR, need for concomitant surgery, young age (<65 years of age in the 2020 ACC/AHA and <75 years of age in the 2021 ESC/EACTS), and anatomy not suitable for transfemoral TAVR (Table 1). Please refer to the chapter on AVR for indications for various other valvular prosthesis, including bioprosthetic, mechanical, valvular repair, or Ross procedure.
Additional factors are provided in Table 2, favoring SAVR vs. TAVR vs. palliation that are not captured in the specific recommendations provided in the 2020 ACC/AHA1 and the 2021 ESC/EACTS valve guidelines,2 as well as the 2019 CCS Position Statement for TAVR.5
Table 1: Comparison of the 2020 ACC/AHA and the 2021 ESC/EACTS valve guidelines in the choice between SAVR vs. TAVR in the management of aortic valve disease
| ACC / AHA 2020 Valve | ESC / EACTS 2021 Valve | Recommendation Class |
|---|---|---|
| SAVR | ||
| Severe AS <65y or life expectancy >20y | <75y and Low risk (STS-Prom/EuroSCORE II <4%) | Class I |
| Asx Abnormal exercise test, very severe AS, rapid progression, or an elevated BNP, SAVR>TAVR | Class I | |
| Valve or vascular anatomy or other factors are not suitable for transfemoral TAVR | Same | Class I |
| Severe AS concomitant surgery | Class I | |
| Moderate AS concomitant surgery | Class IIA | |
| Severe AR, candidates for surgery, TAVR should not be performed | Class III | |
| Either SAVR or Transfemoral TAVR | ||
| 65-80y, no anatomic contraindication to transfemoral TAVR | Class I | |
| Predicted post TAVR or SAVR survival <12 months -> consider palliative care consult | Class I | |
| TAVI | ||
| >80y or life expectancy <10y and no anatomic contraindication to transfemoral TAVR | >75y and high risk (STS-Prom/EuroSCORE II >8%) | Class I |
| Any age with high or prohibitive surgical risk, TAVR if survival >12 months | Same | Class I |
| Non-transfemoral TAVR for inoperable and unsuitable for transfemoral TAVR | Class IIB | |
| Palliative / Bridge | ||
| Survival <12 months -> palliative care | Class I | |
| Critically ill with severe AS -> Percutaneous aortic balloon dilation may be considered as a bridge to SAVR or TAVR | Critically ill or those requiring high risk non cardiac surgery | Class IIB |
Table 2: Additional factors favoring SAVR vs. TAVR vs. palliation.
| Factors | Favors SAVR | Favors TAVR | Favors Palliation |
|---|---|---|---|
| Risk of surgical mortality or morbidity | <3% (ACC/AHA) <4% (ESC/EACTS) | >3% (ACC/AHA) >8% (ESC/EACTS) | >15% (ACC/AHA) |
| Advanced age | + | ||
| Longevity | >2 years | <2 years | <1 year |
| Frailty | + | ||
| Congenital bicuspid valve | + | ||
| Pure aortic regurgitation | + | ||
| Concomitant conditions requiring surgery (multivalve, coronary disease, aneurysm) | + | ||
| Endocarditis | + | ||
| Preference for mechanical valve | + | ||
| Anatomy Nontransfemoral TAVR Risk of coronary obstruction or sequestration Too small or very large aortic annulus LVOT obstruction Risk for conduction disturbances | + | ||
| Concern for patient prosthesis mismatch | + (consider annular enlargement) | ||
| Noncardiac conditions (severe lung, liver, renal disease, mobility issues, dementia) | + | ||
| Procedure specific impediments (prior mediastinal radiation, porcelain aorta, previous cardiac surgery with at risk coronary grafts) | + | ||
Redo SAVR vs. TAVR Valve in Valve for the Management of Prosthetic Aortic Valve Dysfunction
In regards to prosthetic aortic valve dysfunction, the 2020 ACC/AHA1 and the 2021 ESC/EACTS valve guidelines2 provide recommendations with a general preference towards redo SAVR if the patient is a low-risk re-operative candidate. The VARC-36 consortium provides standardized definitions for bioprosthetic valve dysfunction, which are classified as structural, non-structural (which include paravalvular regurgitation, patient prosthesis mismatch, or other conditions such as pannus, inappropriate position, or embolization), as well as thrombosis and endocarditis.
Table 3: Comparison of the 2020 ACC/AHA and the 2021 ESC/EACTS valve guidelines in the choice between redo SAVR vs. TAVR valve-in-valve for the management of prosthetic valve stenosis or regurgitation
| ACC / AHA 2020 Valve | ESC / EACTS 2021 Valve | Recommendation Class |
|---|---|---|
| Prosthetic Valve Stenosis | ||
| Surgical repair | ||
| Bioprosthetic or mechanical, symptomatic severe stenosis, repeat surgery | Same | Class I |
| Asymptomatic severe prosthetic dysfunction, low risk, repeat surgery | Class IIA | |
| Percutaneous repair | ||
| Bioprosthetic aortic valve stenosis, symptomatic, high or prohibitive surgical risk, TAVR valve in valve | Same | Class IIA |
| Bioprosthetic mitral or tricuspid stenosis, high risk, transcatheter valve in valve | Class IIB | |
| Prosthetic Valve Regurgitation | ||
| Surgical repair | ||
| Prosthetic transvalvular or paravalvular leak + (intractable hemolysis or heart failure), surgery | Same, + related to endocarditis | Class I |
| Asymptomatic, severe prosthetic regurgitation, low operative risk, surgery | Class IIA | |
| Percutaneous repair | ||
| Prosthetic paravalvular regurgitation w/ 1) intractable hemolysis or NYHA class III/IV 2) high or prohibitive surgical risk 3) anatomic features suitable for catheter-based therapy, percutaneous repair |
Same | Class IIA |
Supporting Evidence for Current Indications & Guidelines
There have been numerous large multicenter randomized controlled trials evaluating the use of TAVR in the treatment of severe symptomatic AS. The main trials evaluated patients at prohibitive, high, and intermediate operative risk, which demonstrated the safety and effectiveness of TAVR vs. SAVR. The most recent trials evaluated TAVR vs. SAVR in patients at low operative risk treated with either balloon expandable (PARTNER 3 trial)7 or self-expandable valves (EVOLUT Low Risk trial),8 and demonstrated similar midterm outcomes in regards to death and stroke, with reduced rehospitalization. Notably, nearly 25% of patients in both trials underwent concomitant procedures, with patients being treated with TAVR more likely to have ≥mild paravalvular leak than those treated with SAVR (21 vs. 3%). In addition, patients treated with the self-expandable valve were more likely to require a permanent pacemaker than those treated with SAVR (17 vs. 6%).
It is important to note the inclusion and exclusion criteria for these trials. Notably, the majority of trials evaluating TAVR excluded patients with bicuspid aortic valves, severe AR, concomitant disease, LVEF <30%, endocarditis, hypertrophic cardiomyopathy, endocarditis, preexisting prosthetic valve in any position, cardiogenic shock, bleeding disorders or refusal of blood transfusion, body mass index of ≥50 (PARTNER 3), symptomatic carotid or vertebral artery disease, severe dementia, end-organ failure, pregnancy, life expectancy <2 years, and hypersensitivity to metal, aspirin, heparin, or contrast.
Ongoing Trials/Recent Publications
Two brand-new trials were recently published in the context of low-risk patients: the DEDICATE and the NOTION 2 trials. The DEDICATE trial is a randomized noninferiority trial conducted at 38 sites in Germany in which TAVR and SAVR prostheses were selected according to operator discretion. The mean (±SD) age of the patients was 74±4 years, 57% were men, and the median Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) was 1.8% (low surgical risk). The study showed that TAVR was noninferior to SAVR with respect to death from any cause or stroke at 1 year. As important limitations, this trial excluded patients with bicuspid AS, and 70 patients who had been assigned to receive SAVR were treated with TAVR, mostly due to the patient’s request.9 The Nordic Aortic Valve Intervention (NOTION)-2 trial enrolled and 1:1 randomized low-risk patients aged ≤75 years with severe symptomatic AS to TAVR or SAVR. The primary endpoint was a composite of all-cause mortality, stroke, or rehospitalization (related to the procedure, valve, or heart failure) at 12 months. Patients had a mean age of 71.1 years and a median STS PROM of 1.1%. A total of 100 patients (27%) had bicuspid AS. The study showed that the rate of the composite of death, stroke, or rehospitalization at 1 year was similar between TAVR and SAVR, but stroke was more common in TAVR patients. Furthermore, the authors highlighted that TAVR outcomes in young bicuspid AS patients warrant caution and should be further investigated.10
More recent evidence has focused on evaluating the effectiveness of early intervention for asymptomatic AS. These include the RECOVERY trial,11 which demonstrated that SAVR vs. optimized medical therapy for asymptomatic very severe AS (AVA ≤0.75 cm2, Vmax >4.5 m/s, MG ≥50 mmHg) results in reduced mortality at 4 years of follow-up (1 vs. 15%). Furthermore, the AVATAR trial12 demonstrated that SAVR vs. optimized medical therapy for severe AS reduced the primary endpoint at 3 years of all-cause death or major adverse cardiovascular event, including myocardial infarction, stroke, heart failure requiring inotropes or intravenous diuretics (15 vs. 35%), and all-cause mortality (10 vs. 20%). The results of EARLY TAVR,13 which will evaluate TAVR vs. optimized medical therapy for asymptomatic severe AS, are eagerly awaited.
The other emerging area of interest is the outcomes of TAVR explant vs. TAVR valve-in-valve. The international registry of TAVR explant or redo TAVR14 demonstrates that the median time to TAVR explant was 1 year, with patients undergoing TAVR explant having a significantly higher operative mortality than redo TAVR (12 vs. 2%). The reason for higher operative mortality can include unique challenges for TAVR explant, including having the native aortic valve leaflets stuck to the TAVR device, the TAVR device stuck to the aorta, annulus LVOT, or the anterior leaflet of the mitral valve (especially in the case of a self-expandable TAVR valve with its tall profile). The major reasons for reintervention included structural valve deterioration (~55%), followed by paravalvular leak (~30%) and patient prosthesis mismatch, among others. These results demonstrate that reoperation for TAVR explant is not without significant risk, and highlight the importance of achieving an excellent and durable outcome for patients at the time of their initial valvular intervention.
Expert Commentary
Management of aortic valve disease in the context of lifetime management remains an important component of the heart team approach to decision-making. The guidelines above provide a comprehensive overview of the various aspects of decision-making in terms of the index procedure and subsequent procedures as well.
Sources
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- Vahanian A, Beyersdorf F, Praz F, et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J 2022; 43: 561–632.
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- Généreux P, Schwartz A, Oldemeyer B, et al. Design and rationale of the evaluation of transcatheter aortic valve replacement compared to surveillance for patients with asymptomatic severe aortic stenosis: The EARLY TAVR trial. Am Heart J 2024; 268: 94–103.
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