Dedicated plug based closure for large bore access –The MARVEL prospective registry

Abstract

Objectives To study safety and performance of the MANTA Vascular closure device (VCD) under real world conditions in 10 centers. Background The MANTA is a novel plug‐based device for large bore arteriotomy closure. Methods We included all eligible patients who underwent transfemoral large bore percutaneous procedures. Exclusion criteria were per operator's discretion and included severe calcification or marked tortuosity of the access vessel, presence of marked obesity/cachexia or a systolic blood pressure above 180 mmHg. The primary performance endpoint was time to hemostasis. Primary and secondary safety endpoints were major and minor access site related vascular complications up to 30 days, respectively. Vascular complications were adjudicated by an independent clinical event committee according to VARC‐2 criteria. We performed multivariable logistic regression to estimate the effect of baseline and procedural characteristics on any and major vascular complications. Results Between February 2018 and July 2019 500 patients were enrolled undergoing Transcatheter aortic valve replacement (TAVR, N = 496), Balloon aortic valvuloplasty (BAV, N = 2), Mechanical circulatory support (MCS, N = 1) or Endovascular aneurysm repair (EVAR, N = 1). Mean age was 80.8 ± 6.6 years with a median STS‐score of 2.7 [IQR 2.0–4.3] %. MANTA access site complications were major in 20 (4%) and minor in 28 patients (5.6%). Median time to hemostasis was 50 [IQR 20–120] sec. Severe femoral artery calcification, scar presence in groin, longer procedure duration, female gender and history of hypertension were independent predictors for vascular complications. Conclusion In this study, MANTA appeared to be a safe and effective device for large bore access closure under real‐world conditions.

Evaluation of the MANTA Vascular Closure Device in Transfemoral TAVI

“…Indeed, logistic regression revealed that the chance of suffering a major complication is 3.6-fold higher among women than among men. This finding is consistent with previous studies, 4,10,12,26,27 and might be based on gender-specific differences in anatomy. Our analysis shows that female patients have a significantly shorter CFA, a smaller vessel angulation at the puncture site, a shorter minimal luminal diameter, and smaller vessel perimeter and area.…”

“…However, the major vascular complication rate of 4% in the recently published MARVEL prospective registry and in the retrospective study by van Wiechen et al is comparable to our results. 10,11 Similar findings were also observed in the SAFE MANTA trial and in the meta-analysis by Nuis et al 12,20 The comparison of the minor complication rates of the aforementioned studies is similar to the broad diversity of the major adverse events. [9][10][11][12][13][14][15][16][17][18][19][20][21][22] In the present study, we only observed 1% of minor complications, which strongly differs from most of the previous analyses.…”

“…The major vascular adverse event rate attributed to the use of the MANTA VCD presented in the previous studies is very heterogenous, and ranges from none up to 9.3%. [9][10][11][12][13][14][15][16][17][18][19][20][21][22] In our opinion, this variety cannot be clearly explained, and it is only in some extent related to the different study design or methods when analyzing the above-mentioned reports. For example, De Palma et al report a major complication rate of only 1.1%, but evaluated arterial patency post vascular closure only clinically, and angiography was not obtained systematically.…”

“…However, the percentage of use of 14F MANTA varies from 4 to 32% in other publications. [8][9][10]15,20 Of note, in some of the mentioned studies patients with only 12F accesses for procedures other than TAVI were also included. This is another obvious reason for the heterogeneous results of the studies.…”

“…8 The current literature on this topic is mostly limited to relatively small case series with varying results, whereas a complex analysis of potential anatomic predictors has rarely been performed. [9][10][11][12][13][14][15][16][17][18][19][20][21][22] The aim of this study was to evaluate the efficacy and safety of the novel plug-based MANTA-VCD in a large patient cohort as current data was mainly acquired in a relatively small series.…”