• ProGlide, MANTA Debated During Large-Bore Access Closure Session at CRT

    Suture-mediated closure of large-bore vascular access, such as with Perclose ProGlide (Abbott), “has emerged as the preferred technique,” Sahil A. Parikh, MD, said during a focused session on large-bore closure Saturday at CRT 2021 Virtual.

    Nicolas M. Van Mieghem, MD, PhD, advocated for collagen-based, or plug-based, closure devices, of which MANTA (Teleflex) is the first commercially available dedicated large-bore closure device in the U.S. and Europe. Complication rates for both types of devices were low in the MASH pilot randomized trial comparing them, but the bailout options are different.

    Bailout for a ProGlide, Van Mieghem said, is often another ProGlide and is frequent, whereas bailout for MANTA is a covered stent or vascular surgery, which he said is rare.

    That being said, the MASH trial showed no significant difference in outcomes between MANTA and ProGlide.

    So which one is better?

    CRT Course Chairman Ron Waksman, MD, of MedStar Washington Hospital Center, Washington, D.C., posed the question after Parikh and Van Mieghem’s talks.

    Parikh, of Columbia University’s Vagelos College of Physicians and Surgeons, who has used both types of closure devices, said his institution largely uses suture-based closure with 2 ProGlides.

    “It’s comfortable,” he said. “It’s like a warm blanket.”

    Parikh said that in a training institution like his, it is ideal to expose training physicians to the “predominant technique.” Another point in favor of ProGlide is that two ProGlides are still cheaper than a MANTA device, he said.

    Walter Tan, of Wake Forest Baptist Health, Winston Salem, North Carolina, gave a more nuanced answer.

    “I think the answer is, as usual, ‘it depends,’” he said, noting that suture-based and collagen-based devices require different skill sets.

    Itsik Ben-Dor, MD, of MedStar Washington Hospital Center, said he uses both types of devices. If the patient has severe calcification, he prefers to use MANTA.

    Van Mieghem, Thoraxcenter, Rotterdam, Netherlands, said that perhaps 80% of patients can be successfully closed with either device. The experience at two European centers in the MASH trial shows that sometimes, three ProGlides are needed, which means MANTA would be cheaper, whereas two ProGlides are slightly cheaper than one MANTA.

    Van Mieghem agreed with Ben-Dor by saying that MANTA would be his go-to device for patients with severe calcification. Regarding training, Van Mieghem said it is easier to teach fellows to use a MANTA device than two ProGlides.

    “It takes a little bit longer to become an expert suture closure operator,” Van Mieghem said. “But at the end of the day, I would not rely just on MANTA. I think you need to learn both techniques, and then I think as we move forward, we will find out which patient will benefit more from a plug and which patient would be better served with the sutures.”

    Occlusions that were observed with the use of MANTA are rare events, but Tan asked if they could have been prevented.

    Van Mieghem agreed that these occlusions were seen in a patient-level meta-analysis. He said patients with small-caliber vessels with deep arteriotomy pose the biggest challenges for plug-based closure devices.

    “You have less control of what is happening down below,” he said. “So basically, something might happen with the anchor, or you might enter some collagen in the vessel. That is a potential explanation, but the occlusions did not cause the major complications because the occlusions were identified immediately.”

    Nelson L. Bernardo, MD, of MedStar Washington Hospital Center, described yet another closure technique, with stent grafts.

    During his talk, Bernardo noted that there has been an increasing need for large-bore vascular access via the common femoral artery. Early recognition and prompt intervention of bleeding complications arising during this access, which could be life-threatening, “is of the utmost importance.”

    Bernardo said the only treatment, which Bernardo described as “life saver,” for a vessel-wall disruption is the expanded polytetrafluoroethylene (ePTFE) covered stent. He described one case in which he conducted a “bareback,” or sheathless, advance of an ePTFE covered nitinol self-expanding stent to stop a bleed in the right common femoral artery.

    CRT 2021 Virtual takes place Fridays and Saturdays through April 24. On-demand content from the meeting is available here.

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