p.34 抽出テキスト
stays, and more rapid improvements in quality of life compared with those who undergo SAVR.1,2,408,409 Available data do not suggest systematic differences in durability between the two treatment modalities. Randomized controlled trials and observational studies have reported comparable rates of BHV failure related to SVD with transcatheter and surgical valves up to 10 years.2,398,410 However, potential selection and survival bias, the use of variable definitions of SVD, limited follow-up durations, differential attrition rates,2,4,396,400 competing risk of death, and the use of multiple valve types in the surgical arms of RCTs may limit direct comparison.411 Although conclusive evidence is still lacking, concomitant noncomplex CAD can be addressed either by CABG or PCI, while complex CAD favours CABG (see Section 6.1). In the only RCT comparing these two strategies, the transcatheter valve and vessels (TCW) trial, randomization of patients with severe AS and concomitant CAD to FFR-guided PCI plus TAVI resulted in fewer deaths and major bleeding events compared with combined SAVR plus CABG at 12 months.412 However, inferences from trial results are limited due to early termination, modest sample sizes, event rates deviating from those observed in registries and other RCTs, and a low prevalence of complex CAD. 8.5.1.1 Age and life expectancy The relationship between estimated life expectancy and prosthetic heart valve durability determines the likelihood of a future reintervention. Although life expectancy may be a theoretically better guide than age alone for treatment decisions, it is difficult to estimate for an individual patient owing to large geographical (https://ghdx.healthdata.org/record/ ihme-data/gbd-2019-life-tables-1950-2019) and interindividual variability.413 In combination with cardiac and extracardiac comorbidities, as well as anatomical factors, age contributes to risk estimation and represents a pragmatic surrogate for life expectancy. In addition, age thresholds characterize the populations enrolled in RCTs better than life expectancy. It is notable that younger patients with AS seem to have lower life expectancy than the general population despite valve replacement, whereas life expectancy almost normalizes after treatment in older cohorts.414,415 While several trials compared TAVI with SAVR in study populations aged 70–85 years accross the surgical risk spectrum, the representation of patients aged <70 years in RCTs is low and therefore evidence limited.1,394,395,416 8.5.1.2 Anatomical features The advantages of TAVI demonstrated in RCTs are largely confined to patients treated via the transfemoral approach.401 While SAVR remains the preferred treatment option when iliofemoral artery disease precludes transfemoral TAVI, TAVI via a non-transfemoral access (transaxillary, transcarotid, transcaval, transinnominate, or transapical) constitutes an alternative supported by observational data in patients unsuitable for surgery.417–423 Other anatomical factors that favour SAVR or led to exclusion of patients from RCTs comparing TAVI with SAVR are (Figure 9): • Aortic annular dimensions that lie outside sizing recommendations for currently available transcatheter devices. • Excessive or bulky calcifications of the annulus or LVOT, which increase the risk of PVL and annular rupture.424,425 • Increased risk of coronary obstruction with TAVI (cusp height greater than coronary height in combination with shallow sinuses of Valsalva, or high calcium burden of corresponding cusp).329 In contrast, anatomical findings such as porcelain aorta, severe chest deformation, or intact grafts post-CABG favour TAVI. Right anterior thoracotomy or upper hemisternotomy are minimally invasive access alternatives to sternotomy for performing SAVR, which are being used with increasing frequency.426,427 In BAV patients, severe AS usually occurs earlier compared with tricuspid AV and is frequently associated with aortopathy.219,281,428 Prevalence of BAV anatomy sharply increases in younger AS patients.429 BAV anatomy adds complexity to TAVI because of asymmetric AV calcification and elliptical annular shape, as well as the lack of standardization of valve sizing. Patients with BAV have been excluded from almost all landmark RCTs comparing TAVI with SAVR to date.429,430 In the NOTION 2 trial, the composite of all-cause death, stroke, or valve- or HF-related rehospitalization was numerically more frequent (seven vs two events) at 1 year in the underpowered subgroup of 100 patients with BAV (HR, 3.8; 95% CI, 0.8–18.5; P = 0.07).416 Whereas some observational studies report favourable outcomes with TAVI in selected BAV patients,430–432 others suggest higher stroke, annular rupture, and PVL rates as compared with TAVI in tricuspid AS.433 Heavy cusp calcification, particularly in conjunction with a calcified raphe, is associated with increased risk of aortic root injury, PVL, and mortality after TAVI.434 Data on TAVI in two-sinus BAV (Sievers type 0) are scarce.219,435 For the above-mentioned reasons, SAVR remains the primary mode of treatment for stenotic BAV, particularly if patients are young or have coexistent aortopathy or unfavourable valve morphology. TAVI may be considered in patients at increased surgical risk, if anatomy is suitable. Patients with small annuli in relation to their body stature are at increased risk of prosthesis–patient mismatch (PPM) after valve replacement. Annular enlargement allows for implantation of larger BHVs with SAVR. Given its technical complexity it should be performed in experienced centres, and the benefit must be balanced against a possibly higher risk of operative mortality.436 Prostheses with supra-annular design reduce PPM risk with TAVI, although randomized long-term data evaluating the impact on clinical outcomes or valve durability are pending.394,437,438 8.5.1.3 Lifetime management Decision-making concerning the mode of intervention and type of prosthesis needs to integrate expected valve durability, and the potential risks of future reinterventions (Figure 9). Surgical THV explantation followed by SAVR is a rare (<1% of all TAVI procedures) but technically challenging procedure.439–441 Although its incidence among patients undergoing TAVI is stable, absolute numbers are increasing due to the total increase in TAVI procedures performed and the perioperative risk remains high (early mortality rates as high as 12%– 17%).440–445 The majority of surgical THV explantations are performed in patients at high surgical risk with urgent or emergent, non-SVD-related indication for reintervention (frequently endocarditis) within 2 years after TAVI.440,442–444 Implanting a transcatheter aortic valve inside a surgical (TAV-in-SAV) or prior transcatheter valve (TAV-in-TAV) is associated with lower peri-procedural risk compared with redo SAVR.446–451 However, valve-in-valve implantation (particularly TAV-in-SAV) increases the risk of severe PPM,448 which has been linked to adverse outcomes in observational studies.452–455 In addition, valve-in-valve implantation immobilizes the leaflets of the failed prosthesis in an open position, creating a covered tube (or neo-skirt) that may cause direct coronary obstruction in patients with shallow sinuses of Valsalva or indirect Downloaded from academic.oup.com/eurheartj/article/46/44/4635/8234488 by guest on 07 October 2026