WASHINGTON, D.C, (April 28, 2021) – A new study reveals the use of a potassium ferrate hemostatic patch (PFHP) reduces the time to hemostasis for patients receiving cardiac catherization. The findings indicate a faster approach to removing the compression band used during the procedure, without compromising safety. Positive results of the STAT2 trial follow an initial pilot study and are being presented as late-breaking clinical science at the Society for Cardiovascular Angiography and Interventions (SCAI) 2021 Virtual Scientific Sessions.

Cardiac catherization is a procedure performed to evaluate the heart or arteries for patient diagnosis and interventions. This is increasingly performed using transradial approach, where a catheter is inserted through radial artery in the arm to the heart. A compression device called a TR band (TRB) is used to close the hole in the wrist made during the catherization process. Standard protocols require the band to be left on for at least two hours following the procedure.

The study evaluated the use of the StatSeal device patch 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. Both groups had complete TRB deflation attempted at 60 minutes post-procedure. Findings demonstrate the adjunctive use of the patch is safer and faster in deflating the TRB and reduced rebleeding. From a prior pilot study, discharge times were reduced with the use of the Statseal.

“By bringing observation times down from two hours to one, the use of the hemostatic patch has the potential to change practice because we can move toward same-day discharge protocols for cardiac catherization patients,” said Arnold H. Seto, MD, MPA, FSCAI, Long Beach VA Health Care System. “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.”

Results showed the time to complete TRB deflation was shorter with the PFHP compared to for TRB alone (65.9 ± 14.1 min vs. 112.8 ± 56.3 min, P<0.001). Minor rebleeding requiring TRB reinflation was much more frequent without the PFHP (0% vs. 67.3%, p<0.001). The rate of hematomas developed was lower in those who received the PFHP and RAO was rare (<1% in both groups). The reduction in time to TRB deflation (68.1 ± 15.3 min vs 138.2 ± 62.0, P<0.001) and complications was also seen among PCI patients in the PFHP group [10.0% (N=6) vs. 24.2% (N=15), p=0.04]. Additionally, heparin dosing used to reduce risk of radial artery occlusion was up to operator preference. 41% of patients received less than 5000 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 TR band deflation and patient discharge.

“From an operator stand point, these findings are key to improving cath lab throughputs,” said Jordan G. Safirstein, MD, FSCAI, Morristown Medical Center. “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 authors highlighted the benefits for PCI patients receiving stents, that typically spend four to six hours under observation. Their findings challenge this standard of care and indicate they may be able to safely reach discharge sooner, a trend consistent with the recent SCAI document “Length of stay following percutaneous coronary intervention.” Further, authors from Morristown Medical Center note 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.

Sessions Details:

“Radial hemostasis and early TR band deflation is safer and faster with a potassium ferrate hemostatic patch (Statseal): results from the randomized controlled Statseal with TR Band Assessment Trial 2 (STAT2).”