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Page 10 of 19 Masiero et al. Mini-invasive Surg 2022;6:4 https://dx.doi.org/10.20517/2574-1225.2021.104

generation devices, Sapien 3 THVs yielded smaller effective orifice area (EOA) and a higher residual
gradient than Evolut R THVs, and multivariate regression analysis revealed that the use of the Evolut R was
[65]
significantly associated with a lower risk for PPM, especially in patients with small annuli < 23 mm . In
addition, in the Ocean TAVI registry, Evolut R seems to be superior to Sapien 3 in hemodynamic
performance for patients with a small annulus (< 23 mm) up to one year after TAVI (mean prosthesis
2
2
2
gradient 9.0 mmHg vs. 12.0 mmHg; P < 0.001 and index EOA 1.20 cm /m vs. 1.08 cm /m , P < 0.001), with a
2
lower incidence of moderate PPM (6.9% vs. 28.4%; P = 0.015) in the extremely small annulus-matched
cohort (< 21 mm). Nevertheless, severe prosthesis-patient mismatch and all-cause mortality at one year
were similar between the two groups . The supra-annular designed self-expandable ACURATE neo valve
[66]
also resulted in lower transvalvular gradients compared with the SAPIEN 3 Valve (mean gradient 7 mmHg
vs. 11 mmHg; P < 0.0001), as shown in the SCOPE I randomized trial and in another multicenter
propensity-matched analysis reporting less PPM with Acurate Neo compared to SAPIEN 3 in patients with
an aortic annulus area < 400 mm 2[67,68] .

The particularly favorable hemodynamic performance granted by supra-annular devices could theoretically
be an advantage not only in small anatomies but also in the case of paradoxical LFLG AS, when it is of
utmost importance to implant a device with the best hemodynamic performance possible. Paradoxical
LFLG AS is described in about 10% of TAVI patients in large real-world registries, and it is more frequently
encountered in female patients. There is evidence supporting a similar mid-term prognosis after TAVI
procedure in paradoxical LFLG patients than in high gradient AS patients, despite higher perioperative
mortality; however, the impact of device selection in this condition is hypothesized and still has to be
demonstrated .
[69]

Regarding the risk of acute coronary occlusion after TAVI, this rare complication is described more
frequently in women, in patients receiving a balloon-expandable valve, and in those with a previous surgical
bioprosthesis; lower-lying coronary ostium and shallow sinus of Valsalva were associated anatomic
factors . In cases where the risk of coronary occlusion is considered significant, the availability of
[70]
repositionable/retrievable TAVI systems should be considered. However, all these potential advantages of
supra-annular self-expandable devices must always be counterbalanced by the lower rate of selective
[71]
coronary cannulation described with these THVs . Reasons for impaired coronary selective cannulation
with supra-annular devices are the taller-frame design, higher leaflets’ position, and asymmetric skirt, which
might hinder coronary access if a commissural post is placed in front of a coronary ostium. Even if this issue
could be mitigated by commissural alignment technique during valve deployment, nevertheless, in patients
with concomitant coronary artery disease, small sino-tubular junction, and in younger patients, when the
need for future TAVI-in-TAVI is likely expected, a short frame balloon-expandable device (Sapien
iterations or Myval) should be advised .
[72]

Small ilio-femoral vessels and risk of vascular complications
Finally, frailty and small body surface area oriented the choice towards lower profile THVs family, more
adapted to the small iliofemoral diameters. The CoreValve Evolut R and now also the new generation
Evolut Pro+ can be implanted using the InLine™ (Medtronic) sheath with 14 Fr outer diameter equivalent
(minimum vessel diameter requirements 5.0 mm for sizes 23, 26, and 29 mm, in the absence of
circumferential calcification). In addition, the last generation low-profile delivery system FlexNav (Abbott),
designed for Portico and Navitor valve (Abbott), provides the same low insertion profile (access down to
5.0 mm vessels). Specifically, the FlexNav DS features a hydrophilic-coated, integrated sheath to minimize
vessel trauma at the access site. This technological improvement allowed reducing the insertion force and
increasing deliverability respect to Evolut Pro valve with Enveo Pro. The rate of access site-related major