Results
A total of 286 consecutive
patients with severe AS were included in the study. There was a
progressive growth in the number of patients referred for HT discussion,
with a 26% increase seen between the first and third time periods of
the study. Of the 286 patients, 53 were referred for surgical therapy,
210 for TAVR (188 to transfemoral and 22 to non-transfemoral approach)
and 23 were referred for MT (Figure 1 ). Reasons for choosing MT
are summarized in Table 1.
Baseline characteristics according to the initial selected therapeutic
strategy are shown in Table 2 . Analysing data on an
intention-to-treat basis,
patients referred for SAVR were
younger (82 [78-84] year-old) than patients in the TAVR and MT group
(85 [81-87] and 86 [83-90] year-old, respectively)
(p<0.001). There were no significant differences in gender nor
in cardiovascular risk factors. Patients in the SAVR group had lower
risk scores than those assigned to TAVR or MT. Median left ventricular
ejection fraction was lower in the MT group compared to TAVR and SAVR
groups (55% [35-60] vs 60% [52-66] and 60% [51-64],
respectively). Significant mitral regurgitation (MR≥grade III) was less
frequent in the TAVR group (5.5%) compared to MT and SAVR groups
(42.1% and 22.0%, respectively, p<0.001 for both
comparison).
A
total of 22 patients changed their therapy arm after being initially
discussed in HT session due to various reasons (supplementary Table S1).
Thus, considering the final definitive treatment, SAVR was performed in
50 patients, 195 patients underwent TAVR (176, 90.3% through
transfemoral approach) and 41 patients received MT (Figure 1 ).
Baseline characteristics according to definitive treatment group
(as-treated group) are shown in Supplementary Table S2 .
Fifteen baseline clinical characteristics were included in the CART
analysis to determine relevant variables in the decision process
(supplementary Table S3 ). Finally, the HT decision algorithm
was built with six of those variables [age, logistic EuroSCORE,
significant MR, frailty, STS score and estimated glomerular filtration
rate (eGFR)] (figure 2) . Age was the first split point
identified with a cut-off value of 88 years old. Among patients 88-years
and older, logistic EuroSCORE was the determinant parameter which
assigned patients to TAVR or MT. Among patients<88 years old,
significant MR was the next split variable. In patients with significant
MR frailty was the conditioning variable to assign patients to SAVR or
TAVR. In those without MR, STS score and eGFR were recognized as further
relevant factors to decide between SAVR or TAVR.
Procedural characteristics and in-hospital outcomes among patients who
underwent TAVR or SAVR are depicted in Tables 3 and 4 ,
respectively. Importantly, 20% in the SAVR group underwent a
concomitant second valve intervention. In-hospital mortality in the TAVR
group was 4.6% and 12.0% in SAVR group. Specifically, in patients
undergoing isolated aortic valve intervention in-hospital mortality was
7.5% with SAVR, compared with 3.4% in the transfemoral TAVR cohort
(p=0.447). While major vascular complications were more frequent in the
TAVR group, acute kidney injury, significant bleeding, new onset atrial
fibrillation and longer hospital stay occurred more frequently in the
SAVR group. There were no differences between groups in terms of stroke
or the need for permanent pacemaker implantation.
A total of 89 deaths were recorded during follow-up, 45 (53.6%) from a
cardiac cause. In the as-treated analysis, all-cause and cardiovascular
mortality at 1-year were 16.6% and 7.2% in the invasive groups (17.2%
and 6.4% in the TAVR group, 14.0% and 10.2% in SAVR group), and
68.7% and 60.7% in the MT arm, respectively (figure 3).Survival rate according to access site (transfemoral versus
non-transfemoral) and the type of surgery (single versus multiple valve
intervention) are depicted in figure 4 . The survival analysis
according to the intention to treat are shown in supplementary
figure S1 and S2 . All cause rehospitalization rate and NYHA class in
follow-up are shown in supplementary figure S3 .