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Khokhar et al. Mini-invasive Surg 2022;6:2 https://dx.doi.org/10.20517/2574-1225.2021.97 Page 3 of 19
cutaneous tract overlying the arterial puncture site can aid in the advancement of progressively larger
sheaths and vascular closure devices (VCD).
TAVR delivery sheath technology has now evolved whereby most contemporary valves can now be
delivered through 14 Fr sheaths. Modern delivery sheaths such as the iSLEEVE (Boston Scientific), eSheath
(Edwards Lifesciences), and Python (Meril Lifescienes) consist of an inner folded membrane in the
proximal portion which can expand up to 18 Fr inside the descending aorta to accommodate delivery of the
subsequent valve .
[20]
At the end of the procedure, closure of large arteriotomies can be safely and effectively achieved using
VCDs. Their use is associated with a reduction in procedural time, hospital stay, and complication
rates [21,22] . However, VCD failure is still the leading cause of major vascular complications. Multiple suture-
based and collage plug-based solutions exist on the market. For larger arteriotomies, pre-closure with two
parallel ProGlides or one Prostar XL is often preferred [23,24] . Head-to-head comparisons of the two suture-
based approaches has yielded conflicting results [21,22,24-26] , but in both cases choice of arterial puncture and
preparation of the sub-cutaneous tract are essential to ensuring a successful outcomes.
An alternative is the MANTA device (Teleflex Inc, PA, USA), which is the only commercially available
VCD for large bore arterial access . It comes in two sizes, the 14 Fr and 18 Fr MANTA, which are
[27]
indicated for closure of 10-14 and 15-20 Fr sheaths/devices, respectively. Technical success ranges 96%-98%
with a rate of vascular complications of 2%-5%, requiring percutaneous or surgical intervention in around
1%-2% due to vessel dissection or stenosis/occlusion [27-30] . The recent MASH (MANTA vs. Suture-based
vascular closure after transcatheter aortic valve replacement) randomized trial found no difference between
the two strategies in terms of access site-related vascular complications or clinically relevant bleeding .
[31]
However, the use of ProGlide was associated with more device failures, whilst MANTA required greater use
of covered stents/surgical bailouts.
Once the delivery sheath is removed, a final check angiogram of the main access site should be performed to
assess for vessel dissection or perforations. Routine placement of a crossover wire from the contralateral
diagnostic access site is recommended to enable prompt treatment of any complications. In the majority of
cases, occlusive balloon inflation is sufficient to resolve minor perforations or vessel dissections. In cases
with prolonged bleeding, covered stenting might be considered, and, if there is extensive vascular injury,
persistent flow-limiting dissection, or acute limb-threatening ischemia, then surgical repair is indicated.
ANNULAR RUPTURE
Annular rupture remains one of the most feared complications of TAVR due to the potential rapid onset of
hemodynamic collapse and high rate of mortality. It encompasses injuries that can occur to the aortic
annulus, aortic sinuses, and root and left ventricular outflow tract (LVOT), collectively referred to as the
“device landing zone” (DLZ) [32,33] . Its reported incidence is < 1% and usually manifests itself acutely intra-
procedurally, although delayed presentations have been described . Risk factors for annular rupture
[34]
include heavy annular or DLZ calcifications, shallow sinuses of Valsalva, small aortic annulus (< 20 mm),
device over-sizing (> 20%), bicuspid aortic valve, and severe asymmetric sub-annular left ventricle (LV)
hypertrophy in the presence of LVOT calcification [Figure 1] [32,35,36] . Therefore, detailed multi-slice CT
(MSCT) analysis of the DLZ and aortic sinus geometry is critical to minimizing the risk of annular
rupture [35,37] .