"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," Dr. Arnold Seto of VA Long Beach Healthcare System, in Long Beach, California, said in a news release.
"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," said Dr. Seto.
He presented results of the STAT2 trial during the Society for Cardiovascular Angiography and Interventions (SCAI) 2021 Virtual Scientific Sessions.
During transradial cardiac catheterization, a TR compression band is used to close the hole in the wrist made during the catheterization process. The band is typically left on for at least two hours following the procedure.
Dr. Seto and colleagues evaluated time to hemostasis after transradial access using the adjunctive potassium ferrate hemostatic patch (StatSeal, Biolife, LLC) with the TR band compared to the TR band alone. This was an investigator-initiated, unsponsored research trial; Biolife had no involvement.
The researchers enrolled 443 patients across three centers having transradial catheterization (diagnostic and percutaneous coronary intervention); 220 were randomized to the TR band alone and 223 to the TR band plus the StatSeal patch. The primary endpoint was time to successful hemostasis (full TR band deflation) with a 60 minute deflation protocol with or without StatSeal.
Both groups had complete TR band deflation attempted at 60 minutes following the catheterization procedure.
In the overall population, time to complete TR band deflation was shorter with StatSeal compared to TR band alone (mean 65.9 min vs. 112.8 min; P<0.001). This was also true in the PCI subgroup with mean TR band deflation time of 68.1 minutes with the patch vs. 138.2 minutes without (P<0.001)
There were no cases of rebleeding requiring TR band reinflation in the StatSeal group compared with a rate of 67.3% in the patients who did not use StatSeal (P<0.001).
Overall, the rate of hematoma development was lower with than without StatSeal (hematoma < 5 cm: 3.1% vs. 5.5%; hematoma > 5 cm: 0.9% vs. 1.4%).
The overall rate of any complication was also lower in those who received StatSeal (4.5% vs. 8.6%; P=0.08). This was also the case in the PCI subgroup (10.0% vs. 24.2%; P=0.04).
Radial-artery occlusion was rare (less than 1% in both groups), despite 41% of patients having < 5000 units of unfractionated heparin, which is 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.
This study demonstrates that adjunctive use of the StatSeal potassium ferrate hemostatic patch "safely facilitates early deflation" of the TR band, Dr. Seto said in his conference presentation.
"From an operator stand point, these findings are key to improving cath lab throughputs," co-investigator Dr. Jordan Safirstein, of Morristown Medical Center in New Jersey, said in the news 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," he added.
SOURCE: https://scai.org/scai2021 SCAI 2021 Virtual Annual Meeting, presented April 28, 2021.
By Megan Brooks
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