Assessment of the MANTA closure device in transfemoral transcatheter aortic valve replacement: a single-centre observational study

Abstract

Objectives The present study aims to evaluate the efficacy and safety of the MANTA vascular closure device (VCD) (Teleflex, Morrisville, NC, USA) in transfemoral transcatheter aortic valve replacement (TF-TAVR). Background To close the femoral artery in TF-TAVR a VCD is the treatment of choice. Data involving suture-based VCDs have been extensive. Although scarce, results on the MANTA device are promising. There is no consensus yet as to whether the MANTA device is associated with fewer access-site-related vascular/bleeding complications when compared to suture-based VCDs. Methods In this prospective single-arm study, performed at a single centre, a total of 73 patients eligible for TF-TAVR were included and consecutively treated with the MANTA device. Results Access-site-related vascular complications were seen in 13.7% of patients treated with the MANTA device. In this group of patients only minor vascular complications were observed. Access-site-related bleeding complications were rare (6.8%), and device failure was seen in 13.7% of the patients. Conclusions This single-centre study confirms that use of the MANTA device in TF-TAVR is feasible with an acceptable rate of access-site-related complications and no major vascular complications.

Incidence and Predictors of Access Site Vascular Complications Following Ultrasound-Guided MANTA Closure Deployment

“… 25 In our current and previous studies of the US-MANTA technique, 14 the rates of major VCs (1.9 and 1.5%, respectively) were in the lower range of those reported in previous studies. 8 - 14 , 24 Also, our previous study demonstrated a propensity score-matched comparison between US-MANTA versus conventional MANTA, which concluded that the US-guided technique was an independent predictor of less frequent access-site major vascular complications. 14 These results suggest that the ultrasound-guided technique might be beneficial.…”

“…24 However, the incidence of major VCs with MANTA still varied from 0% to 11%, which could be depending on the population and procedural variance included in the studies. [8][9][10][11][12][13]24 When comparing a suture-based VCD with and without ultrasound following TAVR, the ultrasound-guided technique significantly reduced VC. 25 In our current and previous studies of the US-MANTA technique, 14 the rates of major VCs (1.9 and 1.5%, respectively) were in the lower range of those reported in previous studies.…”

“…7 Several single-arm prospective trials with MANTA revealed that 0% to 4.2% of major VCs occur in patients with favorable transfemoral access. 8 - 10 However, retrospective studies showed higher incidences of major VCs (up to 11.0%) in unselected patients compared with selected patients. 11 - 13 Previously, we reported the efficacy of the ultrasound-navigated MANTA deployment (US-MANTA) technique; it had a significantly lower incidence of major VC than conventional MANTA deployment without the use of ultrasound navigation (1.5% vs 7.4%, p=0.030), according to the propensity-score matching method.…”

MANTA closure device shows promise in transfemoral transcatheter aortic valve replacement

“…In this issue of the Netherlands Heart Journal , Halim et al. report the results of a single-centre study assessing the efficacy and safety of the use of the MANTA large-bore vascular closure device in transfemoral transcatheter aortic valve replacement (TF-TAVR) [ 1 ]. The MANTA closure device showed promise in these patients, although a considerable proportion of them had access-site-related vascular complications.…”

“…The outcomes of earlier studies [ 2 – 7 ] are in line with those reported by Halim et al., describing a prevalence of access-site-related vascular complications—as defined by the Valve Academic Research Consortium-II criteria [ 8 ]—ranging from 2–14%. The authors correctly identified a steep learning curve when using the MANTA device, even though they did not analyse this [ 1 ]. Hoffman et al.…”