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Verolino et al. Vessel Plus 2018;2:17 I http://dx.doi.org/10.20517/2574-1209.2018.32 Page 7 of 12
[39]
by Phan et al. analyzed seven studies including a total of 2245 patients (149 with BAV and 2096 with TAV)
undergoing TAVI. According to their results, no difference was observed in 30-day mortality between BAV
and TAV groups. Moreover, no difference was found in post-TAVI mean peak gradients, grading of para-
valvular leaks (moderate or severe) (25.7% vs. 19.9% respectively, P = 0.29), PMK implantations rate (18.5%
vs. 27.9%, P = 0.52), life-threatening bleeding (8.2% vs. 13.9%, P = 0.33) and major bleeding (20% vs. 16.8%,
P = 0.88). Furthermore, need for conventional open-heart surgery (1.9% for BAV group and 1.2% for TAV
group, P = 0.18) and occurrence of vascular complications (8.6% and 10.1% respectively, P = 0.32) were also
[39]
[40]
comparable between the two groups . Confirming these findings, Sannino et al. investigated the efficacy
and safety of TAVI in BAV population. From January 2012 to February 2016, 823 consecutive patients with
severe AS (735 with TAV and 77 with BAV) undergoing TAVI were retrospectively enrolled. Definition of a
successful procedure was established assessing postprocedural valve function, thus measuring echocardio-
graphic parameters such as mean gradient, peak velocity, effective orifice area and evaluating the presence
of paravalvular leak at least of moderate degree. Safety was evaluated by 30-day and 1-year mortality for any
causes, immediate postprocedural mortality and 30-day cardiovascular mortality, procedural success, pace-
maker implantation, and development of procedural complications. No significant differences in in-hospital
mortality (1.1% in BAV group vs. 0.8% in TAV group), 30-day cardiovascular mortality (3.4% vs. 2.3%), 30-
day all cause mortality (3.4% vs. 3.1%) and 1-year all cause mortality (8.5% vs. 10.5%) were found between the
[40]
two groups .

In conclusion, according to the current evidence, bicuspid anatomy should not be excluded from TAVI:
transcatheter valve replacement is deemed a safe and useful procedure both in inpatients with TAV and in
those with BAV.

PATIENTS WITH PURE AORTIC REGURGITATION
Nowadays, TAVI procedure for native AR treatment has a marginal role, mainly as “off-label” application
in very high-risk patients. TAVI for pure native AR has been shown to be more difficult and associated with
lower procedural success, safety, and clinical efficacy rates . Possible explanations for this limited success
[41]
are related to the concept that a certain amount of aortic annulus and/ore valve calcification is necessary
to anchor a balloon- or self-expandable transcatheter valve prosthesis into the annulus . However, limited
[2]
data exist about safety and efficacy of TAVI in this specific subset of patients, mainly reported in several case
[42]
reports and small clinical studies. Yoon et al. enrolled 331 patients with symptomatic, severe pure native
AR undergoing TAVI across 40 participating centers between September 2007 and February 2017. The aim
of this study was to compare the outcomes of TAVI with early- and new-generation prosthesis devices in
symptomatic patients with pure AR. Compared to the early-generation devices, the new ones were associ-
ated with a significantly higher device success rate (81.1% vs. 61.3%, P < 0.001) due to lower rates of second
valve implantation and post-procedural AR (more than moderate). The cumulative rates of all-cause and
cardiovascular death at 1-year follow-up were similar and post-procedural AR was independently associ-
[43]
[42]
ated with worse outcomes . Similar findings were showed by Franzone et al. that confirmed TAVI as
technically feasible in AR patients, with acceptable early morbidity and mortality rates . Overall, the rates
[43]
of complications and of residual moderate or severe AR were low; the main complication was the need of a
second valve implantation . Furthermore, in a large international registry, Sawaya et al. described their
[44]
[43]
experience with TAVI when used to treat patients with severe AR, both those with native AR and those with
failing bioprosthetic surgical heart valves (n = 146, 78 with native AR and 68 with failing surgical devices).
Also in this study, TAVI for pure AR was associated with higher occurrence of device embolization/migra-
tion and significant paravalvular regurgitation especially with old-generation transcatheter heart valves.
However, new-generation devices significantly improved procedural success and clinical efficacy compared
to old ones, suggesting that also in patients with failing surgical prostheses, TAVI may represent a valuable
[44]
therapeutic option (85% vs. 54% and 75% vs. 46%, respectively P < 0.05) . However, further studies and new