By Jane Ehrhardt

Electrophysiologist Tom McElderry, MD, with the UAB Cardiovascular Institute, became the first physician in the world to utilize a new vascular closure system to help stop the bleeding for procedures that need a larger venous access site.

The procedure using the Vascade MVP XL mid-bore venous closure system took place in mid-June, and the device achieved full market release on August 15. McElderry, also the co-director of the UAB Heart and Vascular Center, worked with the engineers at Haemonetics to produce the new device, which is an extension of the original Vascade MVP meant for smaller openings that has been in use since 2019.

The device uses a collapsible disc technology with a collagen patch to close the venous access post-surgery. When the sheath, through which the instruments reach the surgical site, is removed from the vein, the collagen patch is applied and serves as a plug, causing less discomfort for the patient. 

McElderry collaborated with the engineers in a series of experiments deploying collagen in preclinical models. The larger opening presented the team with two challenges. “We had to work on getting the collagen right—the volume that would consistently achieve hemostasis at the vessel,” McElderry says. “And we had to minimize the friction between the collagen and the delivery system so that we could consistently deliver the collagen at the desired location.”

The use of collagen in the Vascade system has been a significant improvement over prior closure techniques. Before Vascade, closure was accomplished by putting direct pressure on the area or a stitch system. “The older ways of managing this could be uncomfortable for the patient,” McElderry says. “Surgeons would put a suture through the skin that needed to be removed later. It’s called a figure-of-eight suture, which can be uncomfortable while the stitch is in and then during the removal process. Patients had to lay immobile for six hours with a 10-pound sandbag over the access site on the leg to allow for some healing of the opening into the vein.

“With the collagen-based devices, the post-procedure immobility time drops to two hours. The Vascade device delivers collagen right on top of where the sheath enters the blood vessel, so that it stops the bleeding at that site. It’s a more consistent closure, so we find less oozing and bleeding after the procedure. It also absorbs into the body over a period of weeks, requiring no post-operative removal.”

Besides the obvious positives of the shorter immobility time, the early ambulation after the procedure also helps older patients. “A lot of our patients have low back pain and having to lay for long periods of time makes that worse,” McElderry says.

Another advantage for patients is the same-day discharge on almost all procedures. “That even includes the procedures we’re doing later in the afternoon,” McElderry says. “Because of the truncated bed rest, they’re able to leave the hospital even if we don’t finish their procedure until five or six o’clock at night.”

Those same-day releases made the most difference during the COVID pandemic, when hospitals were inundated with patients needing longer-term care. The original Vascade became available the year before COVID hit.

“There is a real need for closure of larger access sites now because there’s been an increase in several procedures, including pulse field ablation and the Watchman implant for left atrial appendage occlusion, that need larger sheaths,” McElderry says.

He and his partners have performed hundreds of these two procedures with the Vascade MVP XL in the last three months, which is engineered for closure following procedures requiring 10-12F sheaths (up to 15F in outer diameter). 

McElderry’s involvement in the progression of the collagen-based closure system will continue as the national primary investigator for an upcoming study to expand the indication for even larger sheath sizes.

He says that his time helping to devise the Vascade MVP XL was particularly satisfying. “It was absolutely fun working with the engineers,” he says. “And it’s always rewarding when it’s something that you worked on for so long, and worked on in the experimental environment, that you’re able to take to the patients and see the benefits.”