Key result
MANTA device linked to ~56% fewer bleeding complications than ProGlide after TAVR.
Why the study?
Vascular and bleeding complications increase morbidity and mortality in TAVR, but data regarding the efficacy and safety of the MANTA percutaneous vascular closure device are scarce.
Does the MANTA vascular closure device reduce vascular and bleeding complications compared to ProGlide in patients undergoing TAVR?
Observational (n=325)
Does the MANTA vascular closure device reduce vascular and bleeding complications compared to ProGlide in patients undergoing TAVR?
Odds Ratio: 0.44 (95% CI 0.23–0.83)
Absolute Event Rate: 18% vs 33%
p-value: p=0.01
The MANTA vascular closure device is associated with significantly fewer bleeding complications and shorter hospital stays compared to ProGlide after TAVR.
MANTA-ProGlide comparison in TAVR should not yet alter closure-device selection; leaves open the need for randomized confirmation of any VARC-2 difference.
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.
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Moriyama et al. (2019) conducted an observational in Transcatheter aortic valve replacement (TAVR) (n=325). MANTA percutaneous vascular closure device vs. ProGlide suture-based closure was evaluated on Bleeding complications (OR 0.44, 95% CI 0.23-0.83, p=0.01). The MANTA vascular closure device was associated with significantly fewer bleeding complications than ProGlide after TAVR (18% vs. 33%; OR 0.44, 95% CI 0.23-0.83; p=0.01).
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