Recommendations for Choice of Intervention

CORLOERecommendationsComment/Rationale
ICFor patients in whom TAVR or high-risk surgical AVR is being considered, a heart valve team consisting of an integrated, multidisciplinary group of healthcare professionals with expertise in VHD, cardiac imaging, interventional cardiology, cardiac anesthesia, and cardiac surgery should collaborate to provide optimal patient care.2014 recommendation remains current.
IB-NRSurgical AR is recommended for symptomatic patients with severe AS (Stage D) and asymptomatic patients with severe AS (Stage C) who meet an indication for AVR when surgical risk is low or intermediate (42,43).MODIFIED: LOE updated from A to B-NR. Prior recommendations for intervention choice did not specify patient symptoms. The patient population recommended for surgical AVR encompasses both symptomatic and asymptomatic patients who meet an indication for AVR with low-to-intermediate surgical risk. This is opposed to the patient population recommended for TAVR, in whom symptoms are required to be present. Thus, all recommendations for type of intervention now specify the symptomatic status of the patient.
See Online Data Supplements 5 and 9 (Updated From 2014 VHD Guideline)
AVR is indicated for survival benefit, improvement in symptoms, and improvement in left ventricular (LV) systolic function in patients with severe symptomatic AS (Section 3.2.3 in the 2014 VHD guideline) (42–48). Given the magnitude of the difference in outcomes between those undergoing AVR and those who refuse AVR in historical series, an RCT of AVR versus medical therapy would not be appropriate in patients with a low-to-intermediate surgical risk (Section 2.5 in the 2014 VHD guideline). Outcomes after surgical AVR are excellent in patients who do not have a high procedural risk (43–46,48). Surgical series demonstrate improved symptoms after AVR, and most patients have an improvement in exercise tolerance, as documented in studies with pre- and post-AVR exercise stress testing (43–46,48). The choice of prosthetic valve type is discussed in Section 11.1 of this focused update.
IASurgical AVR or TAVR is recommended for symptomatic patients with severe AS (Stage D) and high risk for surgical AVR, depending on patient-specific procedural risks, values, and preferences (49–51).MODIFIED: COR updated from IIa to I, LOE updated from B to A. Longer-term follow-up and additional RCTs have demonstrated that TAVR is equivalent to surgical AVR for severe symptomatic AS when surgical risk is high.
See Online Data Supplement 9 (Updated From 2014 VHD Guideline)
TAVR has been studied in RCTs, as well as in numerous observational studies and multicenter registries that include large numbers of high-risk patients with severe symptomatic AS (49,50,52–56). In the PARTNER (Placement of Aortic Transcatheter Valve) IA trial of a balloon-expandable valve (50,53), TAVR (n=348) was noninferior to surgical AVR (n=351) for all-cause death at 30 days, 1 year, 2 years, and 5 years (p=0.001) (53,54). The risk of death at 5 years was 67.8% in the TAVR group, compared with 62.4% in the surgical AVR group (hazard ratio [HR]: 1.04, 95% confidence interval [CI]: 0.86 to 1.24; p=0.76) (50). TAVR was performed by the transfemoral approach in 244 patients and the transapical approach in 104 patients. There was no structural valve deterioration requiring repeat AVR in either the TAVR or surgical AVR groups.
In a prospective study that randomized 795 patients to either self-expanding TAVR or surgical AVR, TAVR was associated with an intention-to-treat 1-year survival rate of 14.2%, versus 19.1% with surgical AVR, equivalent to an absolute risk reduction of 4.9% (49). The rate of death or stroke at 3 years was lower with TAVR than with surgical AVR (37.3% versus 46.7%; p=0.006) (51). The patient’s values and preferences, comorbidities, vascular access, anticipated functional outcome, and length of survival after AVR should be considered in the selection of surgical AVR or TAVR for those at high surgical risk. The specific choice of a balloon-expandable valve or self-expanding valve depends on patient anatomy and other considerations (57). TAVR has not been evaluated for asymptomatic patients with severe AS who have a high surgical risk. In these patients, frequent clinical monitoring for symptom onset is appropriate, as discussed in Section 2.3.3 in the 2014 VHD guideline.
IATAVR is recommended for symptomatic patients with severe AS (Stage D) and a prohibitive risk for surgical AVR who have a predicted post-TAVR survival greater than 12 months (58–61).MODIFIED: LOE updated from B to A. Longer-term follow-up from RCTs and additional observational studies has demonstrated the benefit of TAVR in patients with a prohibitive surgical risk.
See Online Data Supplements 5 and 9 (Updated From 2014 VHD Guideline)
TAVR was compared with standard therapy in a prospective RCT of patients with severe symptomatic AS who were deemed inoperable (53,58,60). The rate of all-cause death at 2 years was lower with TAVR (43.3%) (HR: 0.58; 95% CI: 0.36 to 0.92; p=0.02) than with standard medical therapy (68%) (53,58,60). Standard therapy included percutaneous aortic balloon dilation in 84%. There was a reduction in repeat hospitalization with TAVR (55% versus 72.5%; p<0.001). In addition, only 25.2% of survivors were in New York Heart Association (NYHA) class III or IV 1 year after TAVR, compared with 58% of patients receiving standard therapy (p<0.001). However, the rate of major stroke was higher with TAVR than with standard therapy at 30 days (5.05% versus 1.0%; p=0.06) and remained higher at 2 years (13.8% versus 5.5%; p=0.01). Major vascular complications occurred in 16.2% with TAVR versus 1.1% with standard therapy (p<0.001) (53,58,60).
Similarly, in a nonrandomized study of 489 patients with severe symptomatic AS and extreme surgical risk treated with a self-expanding TAVR valve, the rate of all-cause death at 12 months was 26% with TAVR, compared with an expected mortality rate of 43% if patients had been treated medically (59).
Thus, in patients with severe symptomatic AS who are unable to undergo surgical AVR because of a prohibitive surgical risk and who have an expected survival of >1 year after intervention, TAVR is recommended to improve survival and reduce symptoms. This decision should be made only after discussion with the patient about the expected benefits and possible complications of TAVR. Patients with severe AS are considered to have a prohibitive surgical risk if they have a predicted risk with surgery of death or major morbidity (all causes) >50% at 30 days; disease affecting ≥3 major organ systems that is not likely to improve postoperatively; or anatomic factors that preclude or increase the risk of cardiac surgery, such as a heavily calcified (e.g., porcelain) aorta, prior radiation, or an arterial bypass graft adherent to the chest wall (58–61).
IIaB-RTAVR is a reasonable alternative to surgical AVR for symptomatic patients with severe AS (Stage D) and an intermediate surgical risk, depending on patient-specific procedural risks, values, and preferences (62–65).NEW: New RCT showed noninferiority of TAVR to surgical AVR in symptomatic patients with severe AS at intermediate surgical risk.
See Online Data Supplements 5 and 9 (Updated From 2014 VHD Guideline)
In the PARTNER II (Placement of Aortic Transcatheter Valve II) RCT (62), which enrolled symptomatic patients with severe AS at intermediate risk (STS score ≥4%), there was no difference between TAVR and surgical AVR for the primary endpoint of all-cause death or disabling stroke at 2 years (HR: 0.89; 95% CI: 0.73 to 1.09; p=0.25). All-cause death occurred in 16.7% of those randomized to TAVR, compared with 18.0% of those treated with surgical AVR. Disabling stroke occurred in 6.2% of patients treated with TAVR and 6.3% of patients treated with surgical AVR (62).
In an observational study of the SAPIEN 3 valve (63), TAVR was performed in 1,077 intermediate-risk patients with severe symptomatic AS, with the transfemoral approach used in 88% of patients. At 1 year, the rate of all-cause death was 7.4%, disabling stroke occurred in 2%, reintervention was required in 1%, and moderate or severe paravalvular aortic regurgitation was seen in 2%. In a propensity score–matched comparison of SAPIEN 3 TAVR patients and PARTNER 2A surgical AVR patients, TAVR was both noninferior and superior to surgical AVR (propensity score pooled weighted proportion difference: –9.2%; 95% CI: –13.0 to –5.4; p<0.0001) (63,66).
When the choice of surgical AVR or TAVR is being made in an individual patient at intermediate surgical risk, 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 surgical AVR (Section 11 of this focused update) versus a TAVR is an important consideration and is influenced by durability considerations, because durability of transcatheter valves beyond 3 and 4 years is not yet known (65). TAVR has not been studied in patients with severe asymptomatic AS who have an intermediate or low surgical risk. In these patients, frequent clinical monitoring for symptom onset is appropriate, as discussed in Section 2.3.3 in the 2014 VHD guideline. The specific choice of a balloon-expandable valve or self-expanding valve depends on patient anatomy and other considerations (41,57).
IIbCPercutaneous aortic balloon dilation may be considered as a bridge to surgical AVR or TAVR for symptomatic patients with severe AS.2014 recommendation remains current.
III: No BenefitBTAVR is not recommended in patients in whom existing comorbidities would preclude the expected benefit from correction of AS (61).2014 recommendation remains current.