乌鸦传媒

A resorbable collagen plug venous closure device got patients on their feet faster than did manual compression alone after a catheter-based electrophysiology procedure, according to the AMBULATE trial.

Vascular closure with the Vascade MVP device led to faster recovery after cardiac ablation, and with less pain medication use, than seen with randomization to manual compression:

• Time to ambulation (when patient stood and walked 20 feet): 2.8 vs 6.1 hours (P<0.0001)
• Total post-procedure time (from removal of the last device for the index procedure to up and walking): 3.1 vs 6.8 hours (P<0.0001)
• Time to hemostasis: 6.1 vs 13.7 min (P<0.0001)
• Time to eligibility for hospital discharge based on the assessment of the access site: 3.1 vs 6.5 hours (P<0.0001)
• Pain medication usage: 24% vs 49% (P=0.0003)
• Opioid use: 15% vs 36% (P=0.001)

Minor complications were similar at 30 days between groups (1.0% vs 2.4%, P=0.45), and no major access-site complications occurred in either group, according to Mintu Turakhia, MD, MAS, of Stanford University and VA Palo Alto Health Care System, California, and colleagues reporting online in .

An ultrasound substudy of 49 patients showed no safety issues in either group.

AMBULATE's findings were first presented at last year's American Heart Association meeting. Shortly afterward, FDA handed premarket approval to the Vascade MVP. Cardiva Medical announced, in conjunction with publication of the full results, that the device has now received the .

Manual compression protocols typically call for at least 10 minutes of sustained compression at the access site followed by 6 to 8 hours of supine bedrest, the authors noted. "That much immobilization can lead to higher usage of in-dwelling bladder catheters and can also cause discomfort, back pain, and fatigue."

"Vascular closure devices can have the potential advantage of reducing complications," commented Wilber Su, MD, of Banner-University Medical Center Phoenix in Arizona, who was not involved in the study.

However, the cost of each device ($200-250, according to one ) means that its value will need to be proved, Su told 乌鸦传媒. He suggested that the best value for the Vascade MVP may be in high venous pressure systems.

"[T]he cost of the venous closure device may be a consideration, particularly if more than one is needed. An economic analysis factoring in cost differences in outcomes based on AMBULATE is planned," Turakhia and colleagues said.

In addition, there are already other vascular closure devices such as Perclose ProGlide on the market, and even the popular and low-cost figure-8 skin suture has been used for venous access as large as 26F, according to Su.

"Our current method of venous site management is predominantly figure-8 skin suture, and it can even be done by our lab staff. We have had minimal to no complications over hundreds, if not thousands, of cases over the past 5 years," he said.

The AMBULATE trial included 204 people who met preoperative and intraoperative selection criteria out of a pool of 258 enrolled at 13 U.S. sites. All underwent procedures that required two to three femoral venous access sites for 6 to 12 F devices.

Participants were randomized to the Vascade MVP device followed by gentle manual compression for up to 5 minutes before bed rest for 2 to 2.5 hours or to manual compression alone, with duration depending on local practice of the institution and physician. Baseline characteristics were the same between groups.

Vascade MVP recipients expressed greater satisfaction with the duration and comfort of their post-procedure bedrest in a survey before discharge. They said they had greater satisfaction with bedrest pain, especially those who'd had a previous ablation.

Yet the actual time to discharge was similar between groups.

"The overnight stay may reflect long-standing institutional practice. We are cautiously optimistic that shortened time to ambulation may in turn facilitate shorter time to discharge, including obviating the need for an overnight stay in some cases," Turakhia's group wrote.

The study's low complication rates could have stemmed from the select group of patients enrolled, they acknowledged.

"Second, the protocol to assess the eligibility for ambulation was not standardized in the MC [manual compression] group. Rather, it was prespecified that the sites would follow their standard of care with the rationale that the goal was to compare the device against usual operator or institutional care or practice," they continued.

Other caveats include the trial being unblinded and the patient-reported outcome questionnaire not having been validated or applied in prior studies.

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