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found, while patients undergoing TAVI had improved quality of life (change in KCCQ of 12.8 ± 21.9 points vs 3.2 ± 22.8 points; P = 0.018).373 Ongoing trials are expected to provide new insights (NCT04889872 and NCT05149755).

8.5 Treatment options

The mode of AV intervention depends on the estimated life expectancy, expected prosthesis durability, patient preference, and specific trade-offs associated with different treatment options (Figure 8). Most patients with AS undergoing valve intervention in Europe and North America receive a BHV (by either SAVR or TAVI).374 BHVs do not require long-term anticoagulation but have limited durability that varies between devices and is inversely associated with age.375 MHVs are durable but require long-term anticoagulation, with associated thromboembolic and bleeding risks.260,376 In general, an MHV should be preferred in patients aged <60 years and a BHV in patients aged >65 years in aortic position (see Section 14.1). The Ross procedure (replacement of the AV with the patient’s pulmonary autograft combined with homograft pulmonary valve replacement) is associated with excellent long-term survival when performed in selected patients at centres with high expertise.260,263,377,378 Although a valuable surgical option in young patients with prolonged life expectancy in whom anticoagulation is undesirable or contraindicated, it is associated with procedural complexity and the need for reintervention in ∼15% of patients within 15 years (Figure 8).263,377 Balloon aortic valvuloplasty may be rarely considered as a bridge to TAVI or SAVR in carefully selected patients with decompensated AS, and in those with severe AS who require urgent high-risk non-cardiac surgery (NCS) (see Section 15.2.1). The procedure carries significant risks of acute complications.379 A substantial increase in the number of patients undergoing AV intervention has been observed over the past decade as a consequence of the introduction of TAVI, improved diagnostic techniques, and evolving indications for intervention.374,380–383 Nevertheless, there is still wide variation in worldwide access to TAVI as a result of high device costs in comparison with surgical prostheses and variation in healthcare resources and reimbursement systems between countries.384–386 In addition, registries suggest that late referral and undertreatment remain frequent.12,387 8.5.1 The mode of intervention in candidates for a

bioprosthesis The two modes of BHV replacement, TAVI and SAVR, have been compared in RCTs across the spectrum of surgical risk in predominantly elderly patients with tricuspid AS. In patients unsuitable for surgery, TAVI was superior to medical therapy with a number-needed-to-treat of five to prevent one death at 1-year follow-up.388 Subsequently, RCTs showed non-inferiority of TAVI compared with SAVR in patients at high,389–391 intermediate,3,392,393 and low surgical risk,1,394,395 with comparable longer-term outcomes demonstrated during follow-up periods ranging from 4 to 10 years.2,4,396–398 Of note, the majority of patients included in RCTs were male, while patients with low-flow low-gradient AS or adverse anatomical characteristics (including BAVs or complex CAD) were excluded per protocol. Meta-analyses of RCTs show a risk reduction in all-cause death and disabling stroke with TAVI in low-risk patients at 1 year, but no differences to SAVR at longer-term follow-up or in patients at intermediate or high surgical risk.399,400 The early benefit of TAVI in low-risk patients has since been corroborated in the investigator-initiated Randomized, Multicenter, Event-Driven Trial of TAVI vs SAVR in Patients with Symptomatic Severe Aortic-Valve Stenosis (DEDICATE), which met its non-inferiority target with a composite of death and stroke rate at 1 year of 5.4% in the TAVI group vs 10.0% in the SAVR group [hazard ratio (HR), 0.53; 95% confidence interval (CI), 0.35–0.79] and allcause death rates of 2.6% and 6.2% (HR 0.43; 95% CI, 0.24–0.73), respectively.395 Rates of vascular complications and paravalvular leak (PVL) are consistently higher after TAVI despite refined transcatheter heart valve (THV) designs, whereas severe bleeding, acute kidney injury, and newonset AF are more frequent after SAVR.2,4,399,401 Even though PVL has been associated with adverse clinical outcomes,402,403 it does not seem to impact the comparison of clinical outcomes between TAVI and SAVR in RCTs.2,4,395 New pacemaker implantations are more frequent after TAVI, particularly when using self-expanding valves.3,394,404 Conflicting data exist regarding the long-term impact of new pacemaker implantation or new-onset left bundle branch block following AV intervention.405–407 Patients undergoing TAVI have quicker recoveries, shorter hospital





 
 	

 





 

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Figure 8 Aortic valve treatment options. OAC, oral anticoagulation; SAVR, surgical aortic valve replacement; TAVI, transcatheter aortic valve implantation.

ESC Guidelines                                                                                                                                                                                          4667

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