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Page 4 of 12 Verolino et al. Vessel Plus 2018;2:17 I http://dx.doi.org/10.20517/2574-1209.2018.32
[17]
ally not incorporated within current models , should be considered. Of note, frailty is related to different
[18]
factors and several scores have been proposed to measure it. Therefore, Anand et al. indicate frailty evalu-
ation like a marker of physiological reserve and concomitantly a prognostic index. An overall assessment
by score systems also led to identification of patients in whom aortic valve replacement would be futile.
Nishimura at al. recognized that valve interventions are likely to be futile in patients with a life expectancy
less than 1 year or a likelihood of “survival with benefit” less than 25% at 2 years (improvement in quality of
[19]
life or life expectancy or improvement in heart failure or angina class) .

Several randomized trials reported similar outcome results between TAVI and SAVR in the high-risk popu-
lation and the benefit of a percutaneous strategy in patients not suitable for surgery compared with opti-
mal medical treatment. The PARTNER I was the first large randomized trial conducted using a balloon-
expandable device (Edwards Sapien Valve) to test the effectiveness of TAVI and the publication of its 1-year
outcomes has really redefined the conventional wisdom [8,20] . Patients were divided into two groups: the first
one with patients who were considered available for surgery although a high surgical risk (Cohort A, n =
699, STS risk score > 10% or a predicted risk of death by 30 days after surgery of 15% or higher derived from
other comorbidities), and the second one (Cohort B, n = 358) with patients who have a real contraindication
for surgery because of coexisting conditions that would be associated with a predicted probability of 50% or
[21]
more of either death by 30 days after surgery or a serious irreversible condition . In the Cohort A, patients
undergoing TAVI showed similar 1-year all-cause mortality rate compared with SAVR group (24.2% vs.
[11]
26.8%; P = 0.001 for non-inferiority) . Reported 5-year results were comparable as well, with a mortality rate
[22]
observed in 67.8% of patients receiving TAVI vs. 62.4% of those treated with SAVR (P = 0.76) . The prevalence
of stroke was 3.8% and 2.1%, respectively (P = 0.2), although for all neurologic events, the difference between
TAVI and SAVR was significant (P = 0.04), including 4.6% for femoral artery access transcatheter replace-
ment vs. 1.4% for open surgery (P = 0.05). In patients deemed not to be candidates for surgery (Cohort B),
TAVI was superior to standard therapy with significantly reduced 1-year all-cause mortality (30.7% vs. 50.7%;
[11]
P = 0.001) . Recently 5-year follow-up data for this cohort have been reported; principal findings were a
mortality rate of 71.8% in the TAVI group compared with 93.6% of patients on medical therapy. Similarly,
cardiovascular mortality (57.5% vs. 85.9%, HR 0.41, 95% CI: 0.31-0.55, P < 0.0001) and repeat hospitalizations
[23]
(47.6% vs. 87.3%, P < 0.0001) were significantly lower in the TAVI arm at 5 years . The Medtronic CoreValve
US Pivotal Trial confirmed these results; in this series, the self-expandable Medtronic CoreValve implanta-
tion was associated with a 40% reduction in the primary endpoint (combined of all-cause mortality and
[9]
stroke) at 1-year follow-up in the “extreme risk” arm . Also, several registries reflecting real-life TAVI ex-
perience confirmed the effectiveness and safety of TAVI in elderly patients with AS, considered at high-risk
and in whom the percutaneous approach appeared to be a reasonable and convincing option. The FRANCE
[5]
2 Registry enrolled all TAVI performed in 34 centers in France and Monaco, without selection bias , includ-
ing 3195 procedures; of those, 80.4% were percutaneous and 19.6% were surgical. The overall 30-day mortal-
ity was 9.7% (8.5% in the transfemoral group and 13.9% in the transapical group), a percentage closer to those
previously reported by other registries [24,25] but higher compared with randomized trials, probably related to
[11]
high-risk profile of enrolled patients . On the other hand, the 1-year survival rate of 76% was comparable
with randomized data. At the multivariate analysis, logistic EuroSCORE, NYHA functional class III or IV,
the use of transapical approach and the presence of post-procedural periprosthetic regurgitation grade of 2
or more have been demonstrated independent predictors of mortality after 1-year from procedure.

Thus, according to these findings and guideline recommendations for the management of surgical high-risk
patients, it is not surprising that this technique has found widespread use in this subset of patients.

INTERMEDIATE AND LOW RISK PATIENTS
Recently several studies have focused their attention on the large proportion of AS population defined at