Biolife’s StatSeal Transradial Band Shows Reduced Time to Hemostasis After Catheterization

April 28, 2021—A new study reveals that the use of a potassium ferrate hemostatic patch (PFHP) reduces the time to hemostasis for patients receiving cardiac catheterization, announced the Society for Cardiovascular Angiography and Interventions (SCAI). The findings from the STAT2 trial indicate a faster approach to removing the compression band used during the procedure, without compromising safety.

The STAT2 study, which was being presented as late-breaking clinical science at the SCAI 2021 Virtual Scientific Sessions, evaluated the use of a transradial band (TRB) to close the hole in the wrist made during the catheterization process. Standard protocols require the band to be left on for at least 2 hours following the procedure.

The study evaluated the use of the StatSeal patch (Biolife, LLC) compared to using a TRB alone in order to reduce time to hemostasis after transradial access. The study enrolled 443 patients across three centers, including 27.5% receiving percutaneous coronary intervention (PCI). Patients were randomized 1:1 to either the TRB alone or the TRB in addition to the potassium ferrate hemostatic patch.

As reported in the SCAI announcement, both groups had complete TRB deflation attempted at 60 minutes postprocedure. Findings demonstrate the adjunctive use of the patch is safer and faster in deflating the TRB and reduced rebleeding. From the previous pilot study, discharge times were reduced with the use of the StatSeal.

“By bringing observation times down from 2 hours to 1, the use of the hemostatic patch has the potential to change practice because we can move toward same-day discharge protocols for cardiac catheterization patients,” commented Arnold H. Seto, MD, in the SCAI press release. Dr. Seto, who is with Long Beach VA Health Care System in Long Beach, California, continued, “We would be able to shift from long observation times and more frequently tell a patient, ‘you are going home today.’ This is really important for both the clinician and the patient.”

According to the SCAI press release, results from STAT2 showed the time to complete TRB deflation was shorter with the PFHP compared to time to completion for TRB alone (65.9 ± 14.1 min vs 112.8 ± 56.3 min; P < .001). Minor rebleeding requiring TRB reinflation was much more frequent without the PFHP (0% vs 67.3%; P < .001).

Additionally, the rate of hematomas developed was lower in those who received the PFHP and radial artery occlusion was rare (< 1% in both groups). The reduction in time to TRB deflation (68.1 ± 15.3 min vs 138.2 ± 62.0; P < .001) and complications were also seen among PCI patients in the PFHP group [10.0% (n = 6) vs 24.2% (n = 15); P = .04].

Heparin dosing used to reduce risk of radial artery occlusion was determined by operator preference. 41% of patients received less than 5,000 units of heparin, lower than current practice, suggesting that it may be safe to use lower initial doses for diagnostic catheterization in order to expedite TRB deflation and patient discharge.

“From an operator standpoint, these findings are key to improving cath lab throughputs,” commented Jordan G. Safirstein, MD, in the SCAI press release. “Now we know that we can safely discharge patients quicker than we have before, which not only improves efficiencies but is also beneficial for the quality of life for the patient. We hope our results generate positive health care benefits so more patients can be treated with life-saving cardiac solutions.”

The SCAI press release stated that the investigators highlighted the benefits for percutaneous coronary intervention patients receiving stents, who typically spend 4 to 6 hours under observation. The findings challenge this standard of care and indicate patients may be able to safely reach discharge sooner, a trend consistent with the recent SCAI document titled “Length of stay following percutaneous coronary intervention.”

The investigators who are with Morristown Medical Center in Morristown, New Jersey, further note in the SCAI announcement that they are taking initiatives in their radial lounge to base discharge on when safety concerns and adequate hemostasis is met and the patient feels well, rather than on a framework of time.