One-year clinical and echocardiographic outcomes of direct implantation
of a self-expanding valve
Benetos, Georgios
Karmpalioti, Maria
Drakopoulou, Maria and
Stathogiannis, Konstantinos
Xanthopoulou, Maria
Latsios, George
and Synetos, Andreas
Bei, Evangelia
Voudris, Vassilis and
Iakovou, Ioannis
Katsimagklis, Georgios
Moraitis, Sotiris and
Zeniou, Vicki
Danenberg, Haim
Halvatsiotis, Panagiotis and
Vavuranakis, Manolis
Tousoulis, Dimitris
Toutouzas, Konstantinos
Objective To present 1 year clinical and echocardiographic outcomes of
the randomized DIRECT (Pre-dilatation in Transcatheter Aortic Valve
Implantation Trial) trial.
Background Intermediate-term data from randomized studies investigating
the safety and efficacy of direct implantation are lacking.
Methods DIRECT trial randomized 171 consecutive patients with severe
aortic stenosis at four tertiary centers to undergo TAVI with the use of
self-expanding prostheses with (pre-BAV) or without pre-dilatation
(no-BAV). The primary endpoint was device success according to the
VARC-2 criteria. All patients underwent a clinical and echocardiographic
follow-up at 1 year. All-cause and cardiac mortality, stroke, heart
failure hospitalization, and new pacemaker implantation were recorded.
Results At 1 year, four deaths were recorded in pre-BAV group (4.7%)
and three deaths in no-BAV group (3.5%). There was no difference in
Kaplan-Meier plots between the two groups in all-cause mortality at 1
year (log-rank p = .72). Similarly, there was no difference in the
incidence of permanent pacemaker implantation between the two groups at
1 year (27/67-40.3% in no-BAV group versus 20/69-29% in pre-BAV group,
log-rank p = .24). There was no significant difference between pre-BAV
and no BAV group in aortic valve area (1.84 +/- 0.39 cm(2) vs. 1.85 +/-
0.44 cm(2), p = .90), mean aortic valve gradient (8.36 +/- 5.04 vs. 8.00
+/- 4.04 mmHg, p = .65) and moderate or severe paravalvular
regurgitation (5-6.6 vs. 4-5.7%, respectively) at 1 year. The same
applied independently from the performance of post-dilatation at
baseline.
Conclusions Direct, without pre-dilatation, implantation of a
self-expanding valve has no impact on one-year clinical and
echocardiographic outcomes, independently also from the baseline
performance of post-dilatation.
(EN)
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