MANTA—The First Percutaneous Closure System Meeting Surgical Claims

Objectives: As more than 95% of all TAVI procedures meanwhile can be performed by transfemoral approach, there is an increasing need for reliable percutaneous large bore closure systems. Widely used suture-based systems, though having low rates of failure in experienced hands, show a tendency to create vascular stenosis at the point of insertion. This may for sure not be a clinical relevant problem in elderly patients—however, expanding TAVI-indication to younger and physically active patients, these stenosis may become clinically meaningful and should be avoided. Thus, we decided to use a novel closure system to overcome this problem.

Methods: A total of 100 consecutive patients scheduled for TAVI with an age ranging from 75 to 88 years were included into the trial. The only exclusion criterion was severe anterior calcification of the femoral artery. Puncture was carried out after angiography from the contralateral side. Catheter sizes were ranging from 14F to 18F. After the procedure, the arterial wall was sandwiched between a toggle on the inside and a collagen swab on the outside during visually controlled tension on the system.

Results: Successful primary vessel closure could be achieved in 94 patients, with a time to hemostasis (TTH) averaging 5 seconds. In two patients, due to a prolonged TTH, internal compression with a vascular balloon was used for two minutes resulting in a perfect vessel closure. In four patients, the system failed for different reasons; however, all of them related to technical mistakes during the learning curve. In one of these patients, a covered stent was implanted, three patients were repaired surgically. In all patients, post-closure angiography revealed maintenance of the vessel lumen without any stenosis.

Conclusion: The collagen-based Manta closure system provides an interesting alternative to commonly used suture-based systems. The learning phase is short, failure rate is acceptable and in any case so far the reason for failure could immediately be determined. In addition, no patient had angiographic signs of stenosis after closure.