Insights From a Multidisciplinary Introduction of the MANTA Vascular Closure Device.

OBJECTIVES: The aim of this paper is to report insights from the first 100 consecutive cardiovascular procedures with MANTA closure.

BACKGROUND: The collagen-based MANTA vascular closure device (Teleflex, Wayne, Pennsylvania) has recently been approved for the closure of large-bore femoral access.

METHODS: Procedural and access site-related complications were analyzed according to Valve Academic Research Consortium-2 criteria. Duration of bleeding after device closure was recorded.

RESULTS: Patients underwent transcatheter aortic valve replacement (n = 75), endovascular aortic replacement (n = 21), or Impella left ventricular support (n = 4). In these 100 patients, a total of 122 MANTA devices were used (22 patients had bilateral large-bore access). None of the patients received protamine. Immediate hemostasis was achieved in 70 patients and hemostasis within 5 min in 87 patients. There were 7 patients with major and 4 patients with minor MANTA-associated vascular complications: femoral artery occlusion in 2, ongoing bleeding in 5, and pseudoaneurysm formation in 4 patients. One patient was treated with covered stent implantation, 7 required surgical revision, and 4 received thrombin injection. Complications occurred significantly more often in patients with peripheral artery disease and a minimal artery diameter <6 mm. Careful review of these complications suggests 3 distinct failure mechanisms. In vessels with narrow femoral artery diameters, elevation of the toggle may lead to occlusion of the artery, incomplete apposition of the plug may lead to perivascular (potentially retroperitoneal) bleeding, or pseudoaneurysm formation may occur.

CONCLUSIONS: In this paper, MANTA-associated complications are addressed, 3 distinct failure mechanisms are suggested, and strategies to avoid these complications and improve procedural outcomes are discussed.