Hollywood, FL (January 25, 2020)—There are two devices for large bore vessel closure for which there is extensive experience, only one of which is approved in the United States, reported Zvonimir Krajcer, MD, director of peripheral vascular disease at Texas Heart Institute.
His talk at the International Symposium on Endovascular Therapy (ISET) was designed to provide attendees with an overview of devices for large vessel closure, as well as the indications, advantages, and disadvantages of each.
The Prostar XL, 10-French, braided suture-mediated vascular closure device (VCD) by Abbott has been in use since 1994. One device can close an access site up to 24-French, but it is only approved in Europe and not in the U.S.
Besides the obvious disadvantage of not being FDA approved, “it has a very prolonged learning curve and it's not extensively used,” said Krajcer.
The Perclose ProGlide (Abbott), on the other hand, is approved and extensively used and has a broad indication for both femoral arterial and venous access. “All of us use it for diagnostic interventional procedures,” said Krajcer. Its learning curve is shorter and it can be used for large bore closure up to 21 French. “A disadvantage, if any, is that you have to use two devices in most scenarios to achieve a very high rate of technical success,” he added.
ProGlide’s technical success has been well validated by Dr. Krajcer and others. Technical success in the Percutaneous Endovascular Aneurysm Repair (PEVAR) trial was 94%, reaching 97% in the LIFE (Least Invasive Fast-track EVAR) registry.
“Unmet needs of current generation suture-mediated VCDs include endovascular emergencies. In the event of true emergencies, such as a ruptured ascending aortic or thoracic abdominal aneurysms, or when mechanical circulatory support is needed, “you don't have an extra 10 to 15 minutes to spend on the pre-closing…and these devices can be used in a pre-close fashion,” noted Krajcer.
There are several new devices in development, but only one has been approved in the U.S. to date—the Manta device (Teleflex).
Manta is an over-the-wire device that achieves hemostasis by “sandwiching” arteriotomy. “It’s like a large Angio-seal, except that it has some extra unique features for large bore closure,” said Krajcer. It uses an anchor, which is intravascular, and an extravascular bovine collagen plug,” he added. Unlike the Angio-Seal, it has a 316L stainless steel suture lock.
Manta comes in 14 French and 18 French, with the larger device closing access sites up to 25 French. “In my experience it’s a very, very reliable device. I’ve done about 98 of them with 100% success rate,” reported Krajcer.
In the Manta U.S. IDE Pivotal trial, Manta demonstrated a technical success rate of 97.7%. “Hemostasis was achieved in less than 1 minute in 86% of patients and in less than 5 minutes in 94% of patients,” said Krajcer.
Other devices available in Europe or under development include InClosure by InSeal Medical (Caesarea, Israel), PerQseal by Vivasure Medical (Galway, Ireland), Cross-Seal by Medeon Biodesign & Terumo, Closer LB by Rex Medical, and Velox LB by Transluminal Technologies, (Syracuse, NY).
“Large border closure devices benefit patients because they are minimally invasive, avoid the complications of general anesthesia, result in less blood loss, fewer groin complications, less pain and a quicker recovery time.
From the physician and hospital sides, they offer a quicker procedure, no anesthesia delay, greater patient satisfaction, lower cost, and improved efficiency.
In conclusion, “ProGlide, obviously, has several advantages because it’s commonly used and well-accepted,” he said. “It’s been validated with high technical success up to 97%, and it’s relatively inexpensive compared to other devices,” said Dr. Krajcer. However, ProGlide can only be used in a pre-close fashion and emergency cases might present an issue.
Post-intervention large bore VCD are great in emergencies, he added, and Manta has performed well in studies, but the downside to both of the currently available devices is the lack of reimbursement from payors.
“There is no reimbursement from payors, and that certainly is an issue, particularly with newer generation, expensive devices” said Dr. Krajcer.