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

February 2, 2021 Circulation. 2021;143:e72–e227. DOI: 10.1161/CIR.0000000000000923 e102

CLINICAL STATEMENTS AND GUIDELINES attributable to severe AS. From a pathophysiological point of view, the reasons for thinking that TAVI might be especially beneficial with severe AS and a low LVEF are the avoidance of myocardial ischemia with an open surgical procedure and the greater reduction in afterload with a larger effective valve area. However, outcome data from RCTs show that a low LVEF also is a risk factor for adverse outcomes even with TAVI.29 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. Studies on the potential benefit of TAVI in patients with moderate AS and LV systolic dysfunction are in progress. 5.	 Published RCTs comparing TAVI and SAVR included only patients with symptoms attributable to severe AS. Asymptomatic patients with COR 2a indications for AVR should either undergo SAVR or wait until a COR 1 indication is present before intervention. The recommendation for SAVR in preference to TAVI includes asymptomatic patients for whom AVR is being considered because of an abnormal exercise blood pressure response, an elevated serum BNP level, rapid hemodynamic progression, or very severe AS with a velocity of ≥5 m/s. 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.30–32

6.	 Published RCTs have focused primarily on TAVI via the transfemoral vascular access route. The mortality rate has been higher with TAVI by nonfemoral access routes than with SAVR, possibly because of the access approach itself, but more likely because of the higher comorbidity burden and risk in patients with vascular disease severe enough to preclude transfemoral access. When transfemoral TAVI is not feasible, SAVR or palliative care options should be included in the shared decision-making discussion. 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.1,33 7.	 TAVI was compared with standard medical therapy in a prospective RCT of patients with severe symptomatic AS who were deemed inoperable.12,14,34 The rate of all-cause death at 2 years was lower with TAVI (43.3%) (HR: 0.58; 95% CI: 0.36–0.92; P=0.02) than with standard medical therapy (68%).12,14,34 Standard therapy included percutaneous aortic balloon dilation in 84%. There was a reduction in repeat hospitalization with TAVI (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 TAVI, compared with 58% of patients receiving standard therapy (P<0.001). However, the rate of major stroke was higher with TAVI 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 TAVI versus 1.1% with standard therapy (P<0.001).12,14,34 Similarly, in a nonrandomized study of 489 patients with severe symptomatic AS and extreme surgical risk treated with a self-expanding TAVI valve, the rate of all-cause death at 12 months was 26% with TAVI, compared with an expected mortality rate of 43% if patients had been treated medically.13 The final choice of TAVI versus palliative care is based on a shared decision-making process that accounts for the patient’s values and preferences and includes discussion of the indication, risks, and benefits for and against each approach. 8.	 The survival and symptom reduction benefit of TAVI is seen only in appropriately selected patients. Baseline clinical factors associated with a poor outcome after TAVI include advanced age, frailty, smoking or chronic obstructive pulmonary disease, pulmonary hypertension, liver disease, prior stroke, anemia, and other systemic conditions. The STS estimated surgical risk score provides a useful measure of the extent of patient comorbidities and may help identify which patients will benefit from TAVI. Patients with a mechanical impediment to SAVR, such as a porcelain aorta or prior chest radiation damage, may have better outcomes after TAVI than do frail patients or those with moderate to severe disease in more than one other organ system.12,14,34 The likely benefits and risks of TAVI are considered in weighing the risk–benefit ratio of intervention in an individual patient. TAVI is not recommended in patients with 1) a life expectancy of <1 year even with a successful procedure or 2) those with a chance of “survival with benefit” of <25% at 2 years.

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