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TAVR Access Closure Devices Not Equal, Study Shows

LAS VEGAS — Bleeding complication risk after transcatheter aortic valve replacement (TAVR) isn’t the same between two of the most commonly used femoral vascular closure devices, one study showed, while another suggested a device left in next to the closure site could help catch bleeds early.

Both trials were presented at a late-breaking trial session here at the Society for Cardiovascular Angiography and Interventions annual meeting.

In a substudy of the BRAVO 3 trial, the Prostar closure device had a 24% rate of 30-day vascular complications overall compared with 15% with the ProGlide device (adjusted OR 0.54, P<0.01), reported David Power, MD, of the Icahn School of Medicine at Mount Sinai in New York City.

Major vascular complications trended in the same direction (aOR 0.62, P=0.07), but the difference was driven by the 45% difference in minor vascular complications, which Power said was mainly related to transfusion, use of additional closure devices, and nonroutine compression of the vascular site.

Prostar also had a higher rate of acute kidney injury (25% vs 17%, aOR 0.61, P=0.01). Power suggested this could be explained by increased use of contrast imaging studies when there was concern about incomplete closure.

The analysis included 746 patients who got a vascular closure device (93% of the original trial population). Operators selected Prostar for 47% and ProGlide for the other 53%. The main trial had shown that randomization to bivalirudin (Angiomax) wasn’t better than heparin for TAVR either on bleeding risk or major adverse cardiovascular events.

Ease of use may have driven some of the findings, Power suggested at a press conference. “[With the] ProGlide device, typically operators are more comfortable with it, they’ve used it, it’s typically used for a smaller femoral access site. It’s licensed for a 6 Fr access. One of the big things is there’s a pre-close technique used with two of these ProGlide devices. So if one of the devices misfires, there’s some procedural redundancy in this.”

“The Prostar device is usually used on it’s own. So if there’s some type of mistake made or if it’s not perfect apposition that may lead to increased bleeding, increased vascular complications,” he added. “It appears like the preponderance of data is moving away from the use of Prostar.”

The findings were adjusted for sheath size but not for number of devices used.

“As the increasing number of people [are] having TAVR, it points out 25% still have a vascular complication,” commented Timothy Henry, MD, of Christ Hospital in Cincinnati. “This is a nice step but it shows we still have a ways to go. This area hasn’t had as much attention as it needs.”

In a separate first-in-man study for the recently FDA-approved Saranas Early Bird bleed detection device, it had “great” correlation with CT scans (Cohen’s kappa 0.84 overall).

Positive predictive value was 92% or greater and specificity was 75% or better, Philippe Généreux, MD, of Atlantic Health in Morristown, New Jersey, reported at the late-breaking trial session.

“The current paradigm actually is to wait for symptoms,” which can take hours, he said at a press conference.

The device is a standard 6-8 Fr sheath with electrodes embedded that detect a bioimpedance drop due to bleeding and then set off an audible and visual alert on the attached device, indicating three stages of severity.

The study included 60 U.S. adults getting TAVR (67%) or another endovascular procedure requiring arterial or venous access. After a CT scan, the Early Bird device was placed for up to 12 hours in a vessel next to the one that had the larger-bore sheath inserted for the procedure. Just before Early Bird removal, a second non-contrast CT scan was taken to confirm or refute what the device reported.

No bleed was detected in 35% of cases, level 1 bleeds were detected in 33%, level 2 in 25%, and level 3 in 7%. More level 2 and 3 bleeds happened post-procedure than during the procedure.

Independent core lab analysis of the CT scans showed infiltration in 56.7% of patients and hematoma in 36.7%.

“Severe bleeding events such as retroperitoneal bleed or life-threatening bleeding were non-existent in our cohort — most likely the reflection of highly experienced operators, but also suggesting that the detection, notification, and awareness of early sub-clinical bleed could have led to these favorable outcomes,” Power said at the presentation.

In the study, the alerts led to increased awareness and compression or other attention to the closure site in about three-quarters of cases and hemostatic agent use in perhaps 20%.

However, further study is needed to show whether systematic use of the device could impact outcomes, he acknowledged. A post-approval registry is slated to start soon, he added.

The registry may also help determine cost-effectiveness, commented press conference moderator M. Chadi Alraies, MD, MPH, of Wayne State University in Detroit. Based on the cost, good patient selection could end up being high-risk patients and those with calcified arteries, he added.

BRAVO 3 was supported by the Medicines Company, but the subanalysis was not industry supported.

Power disclosed no relevant relationships with industry.

Généreux disclosed relationships with Abbott Vascular, Abiomed, Cardinal Health/Cordis, Cardiovascular System, Edwards Lifesciences, Medtronic, Opsens, Penumbra, Pi-Cardia, Puzzle Medical, Soundbite Medical, SIG.NUM, SARANAS, and TRYTON Medical.