Aims: Vascular and bleeding complications increase morbidity and mortality in transcatheter aortic valve replacement (TAVR). However, data regarding the efficacy and safety of the MANTA percutaneous vascular closure device (VCD) are scarce. The present study sought to compare VARC-2 complications between collagen plug-based closure using "MANTA" and suture-based closure using "ProGlide" to evaluate the efficacy of the novel MANTA VCD.
Methods and results: We performed a retrospective, propensity score-matched study to compare vascular and bleeding complications in 325 consecutive patients who underwent TAVR using MANTA and ProGlide. The 1:1 propensity score matching resulted in 111 matched pairs. For MANTA- versus ProGlide-treated patients, all-cause mortality (0% vs. 4%, p=0.02), vascular complications (14% vs. 21%, p=0.21), and bleeding complications (18% vs. 33%, p=0.01) were observed. Access-site vascular injury was significantly less frequent in patients who received MANTA versus ProGlide (8% vs. 17%, p=0.04). MANTA resulted in a significantly lower haemoglobin decrease (16.4 vs. 20.0 g/l, p=0.04) and shorter hospital stay after TAVR (3.3 vs. 5.8 days, p=0.02). It was also associated with fewer bleeding complications (OR 0.44, 95% CI: 0.23-0.83; p=0.01). Moreover, significant decreases of all endpoints were not seen across the procedure date tertiles in the MANTA group.
Conclusions: MANTA resulted in a significantly lower complication rate, especially for bleeding, than did ProGlide, despite the operators' inexperience in the use of MANTA.