Why the study?
TAVI requires large-bore arteriotomy with vascular complication rates up to 21%, and early studies suggested lower complications with the newer MANTA closure system compared to suture-based systems.
Does the MANTA closure system reduce vascular complications compared to the PROSTAR system in patients undergoing femoral TAVI?
Does the MANTA closure system reduce vascular complications compared to the PROSTAR system in patients undergoing femoral TAVI?
The MANTA closure device is equivalent to PROSTAR for overall vascular complications in TAVI but significantly reduces bleeding complications and closure failures, despite a higher rate of non-clinical femoral stenosis.
MANTA was associated with fewer bleeding complications without excess vascular events after TAVI; leaves open superiority versus PROSTAR in randomized trials.
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.
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Benic et al. (2023) studied this question.
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