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. 2023 Oct 23;12(20):6697.
doi: 10.3390/jcm12206697.

Vascular Complications Following Transcatheter Aortic Valve Implantation, Using MANTA (Collagen Plug-Based) versus PROSTAR (Suture-Based), from a French Single-Center Retrospective Registry

Clément Benic  1 , Pierre Philippe Nicol  1 , Sinda Hannachi  1 , Martine Gilard  1 , Romain Didier  1 , Bahaa Nasr  2
Affiliations

Vascular Complications Following Transcatheter Aortic Valve Implantation, Using MANTA (Collagen Plug-Based) versus PROSTAR (Suture-Based), from a French Single-Center Retrospective Registry

Clément Benic et al. J Clin Med. .

Abstract

TAVI requires a large-bore arteriotomy. Closure is usually performed by the suture system. Some studies report a vascular complication rate of up to 21%. MANTA is a recently developed percutaneous closure system dedicated to large caliber vessels based on an anchoring system. Early studies report a lower rate of vascular complications with MANTA devices. This single-center retrospective study included all patients who underwent femoral TAVI at the Brest University Hospital from 20 November 2019 to 31 March 2021. The primary endpoint is the rate of vascular complications (major and minor) pre and post-TAVI procedure. In total, 264 patients were included. There were no significant differences in vascular complications (major and minor) between the two groups (13.6% in the MANTA group versus 21.2% in the PROSTAR group; p = 0.105), although there was a tendency to have fewer minor vascular complications in the Manta group (12.1% versus 20.5%; p = 0.067). Manta was associated with a lower rate of bleeding complications (3.8% versus 15.2%; p = 0.002), predominantly minor complications with fewer closure failures (4.5% versus 13.6%; p = 0.01), less use of covered stents (4.5% versus 12.9%; p = 0.016), and with no difference in the need for vascular surgery compared to the Prostar group (1.5% versus 2.3%; p = 0.652). On the other hand, Manta was associated with a higher rate of femoral stenosis (4.5% versus 0%; p = 0.013) without clinical significance (1.5% versus 0%; p = 0.156). The Manta and Prostar devices are equivalent in terms of vascular complications. The Manta, compared to the Prostar, is associated with fewer bleeding complications.

Keywords: MANTA; PROSTAR; TAVI; femoral access; vascular complications.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Calcification degree of femoral access.
Figure 2
Figure 2
Prostar System: Visualization of the 4 nitinol needles in the vessel wall connected in pairs to a suture.
Figure 3
Figure 3
Manta System: Visualization of the bioresorbable part on the inner side of the vessel (green) and the hemostatic collagen (white) on the external side.
Figure 4
Figure 4
Flow chart. (TAVR: TransAortic Valve Replacement).
Figure 5
Figure 5
Vascular complications (VARC-2) according to the closing device.
Figure 6
Figure 6
Type and distribution of vascular complications for (a) PROSTAR device and (b) MANTA device.
Figure 7
Figure 7
Bleeding complications according to the closing device (* p < 0.05).
See this image and copyright information in PMC

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