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Otto et al 2020 ACC/AHA Guideline for the Management of Valvular Heart Disease

Circulation. 2021;143:e72–e227. DOI: 10.1161/CIR.0000000000000923 February 2, 2021 e101 CLINICAL STATEMENTS AND GUIDELINES

statistical averages and serve as the starting point for shared decision-making, not as absolute values for chronological age. Some younger patients with comorbid conditions have a limited life expectancy, whereas some older patients have a longer-than-average life expectancy. Decision-making should be individualized on the basis of patient-specific factors that affect longevity or quality of life, such as comorbid cardiac and noncardiac conditions, frailty, dementia, and other factors. In addition, the choice of implantation approach is based on a shared decision-making process that accounts for the patient’s values and preferences and includes discussion of the indications for and against each approach and the potential need for and risks associated with valve reintervention.16–19

Recommendation-Specific Supportive Text

1.	 SAVR has demonstrated excellent durability and outcomes for both mechanical and bioprosthetic valves. Earlier RCTs comparing SAVR and TAVI in patients with a higher surgical risk included only older patients, with a mean age in the mid-80s. More recent RCTs that included patients at low to intermediate surgical risk had a mean age in the mid-70s, but there were very few patients <65 years of age, so the evidence base cannot be extrapolated to these patients. In addition, valve durability is of higher priority in younger patients, who typically have a longer life expectancy and lower surgical risk. As longer-term data on TAVI valve durability become available, the age range for recommending TAVI may shift, but at this time the most prudent course, based on the published evidence, is to recommend SAVR for adults <65 years of age unless life expectancy is limited by comorbid cardiac or noncardiac conditions. The final choice of implantation approach is based on a shared decision-making process that accounts for the patient’s values and preferences and includes discussion of the indications for and against each approach and the potential need for and risks associated with valve reintervention. There are no data for the use of TAVI in patients <65 years of age.21 2.	 Both SAVR and TAVI are effective approaches to AVR in adults 65 to 80 years of age. Patients enrolled in RCTs of TAVI versus SAVR had highvelocity severe AS (Stage D1). However, less robust data from observational studies and registry data are encouraging with regard to TAVI for symptomatic patients with low-flow, low-gradient severe AS (Stages D2 and D3). Thus, these guidelines make the same recommendations for symptomatic patients with confirmed severe AS regardless of flow rate. TAVI has a slightly lower mortality risk and is associated with a shorter hospital length of stay, more rapid return to normal activities, lower risk of transient or permanent AF, less bleeding, and less pain than SAVR. On the other hand, SAVR is associated with a lower risk of paravalvular leak, less need for valve reintervention, and less need for a permanent pacemaker. When the choice of SAVR or TAVI is being made in an individual patient between 65 and 80 years of age, other factors, such as vascular access, comorbid cardiac and noncardiac conditions that affect risk of either approach, expected functional status and survival after AVR, and patient values and preferences, must be considered. The choice of mechanical or bioprosthetic SAVR (Section 11) versus a TAVI is an important consideration and is influenced by durability considerations, because durability of transcatheter valves beyond 5 to 6 years is not yet known.2

3.	 TAVI is a safe and effective procedure for treatment of severe symptomatic AS in all adults regardless of estimated surgical risk. The mortality rate for transfemoral TAVI is lower than that for SAVR, with a HR of 0.88 and a 95% CI of 0.78 to 0.99 in a meta-analysis of RCTs. TAVI also is associated with a lower risk of stroke (HR: 0.81; 95% CI: 0.68–0.98; P=0.028), major bleeding, and AF, as well as a shorter hospital length of stay, less pain, and more rapid return to normal activities.3 Compared with SAVR, TAVI results in higher rates of vascular complications, paravalvular regurgitation, permanent pacemaker implantation, and valve intervention, but most patients will consider that the advantages of TAVI outweigh these disadvantages. TAVI valves are durable to at least 5 years, and the limited data on TAVI durability are of less concern to most patients >80 years of age because the valve durability is likely to be longer than the patient’s life expectancy.22 If significant valve deterioration does occur, a second TAVI within the first prosthesis, (called a valve-in-valve TAVI), is likely to be possible. When a transfemoral approach is not possible, other factors, such as alternative vascular access, comorbid cardiac and noncardiac conditions, expected functional status and survival after AVR, and patient values and preferences, must be considered. The specific choice of a balloon-expandable valve or selfexpanding valve depends on patient anatomy and other considerations.23–28 4.	 An LVEF <50% in a patient with severe AS is a COR 1 indication for AVR, so the choice of TAVI versus SAVR in these patients is based on the same considerations as in patients with symptoms

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