A topical hemostatic patch located under a standard air bladder bracelet reduces the time of hemostasis after transradial cardiac catheterization without increasing complications, according to the results of STAT2 test.
The mean time to successful hemostasis fell from 113 minutes with the bladder bracelet (TR Band, Terumo) alone to 66 minutes when combined with the StatSeal (Biolife) hemostatic patch (Pg <.001).
“On average, most people take about 2 hours with the TR band alone to provide hemostasis, instead this is removed and bled,” said study author Arnold Seto, MD, MPA , in the Society for Cardiovascular Angiography and Interventions (SCAI) 2021 Scientific Sessions.
There were no hemorrhages that needed reinflation among the patients treated with the patch, while 67.3% of those treated with the band only required reinflation an average of 2.3 times due to bleeding at 60 minutes.
Possible implications of the findings are anterior discharge after catheterization, especially after percutaneous coronary intervention (PCI); reduction of nursing burden, time, and costs; and reduced heparin doses below the usual recommended 5,000 units, said Seto, of Long Beach VA Medical Center, California.
He noted that there is no standardized protocol for compression with the TR band, with wide variations in clinical practice. Previous studies have shown that a longer hemostasis time predicts radial artery occlusion. Shorter compression times can reduce radial artery occlusion, but if they are too short, they can cause more and more repeated blood reinflation.
The StatSeal patch contains a hydrophilic polymer that dehydrates blood solids and potassium ferrate that groups together blood solids and proteins to form a seal, Seto explained.
Passing the pilot test
In a pilot study, complementary use of the patch significantly reduced the deflation time of the TR band from 160 to 43 minutes. The protocol, however, allowed the TR Band-alone group to start deflation after 120 minutes, compared to the 40 minutes of the patch, which “potentially skewed the results,” Seto said. In addition, the patch was associated with a numerical increase in hematomas and radial artery occlusion.
To address this in the multicenter STAT2 study initiated by the researcher, the complete deflation of the TR band was 60 minutes for all patients and the deflated band was left in place for 30 minutes to avoid altering the clot.
The use of unfractionated heparin was left to the preference of the operator over a minimum of 5,000 units in the pilot study. In addition, a larger version of the patch, Statseal Advanced RAD, was used in 77% of patients and intravenous glycoprotein inhibitors and gangsters, a source of hematomas from the pilot study, was excluded.
Among the 443 patients undergoing diagnostic catheterization and PCI, 223 were randomized to the patch plus the TR band and 220 to the TR band alone. Most patients underwent diagnostic catheterization (73% vs 71.8%) and had unfractionated heparin (mean, 5608 vs 5555 units).
The mean time to deflate the TR band was shorter with StatSeal, a difference that was even more pronounced in the PCI subgroup, despite receiving higher doses of heparin (mean, 68 vs. 138 minutes; Pg <.001), Seto pointed out.
Overall complications were numerically lower in the StatSeal group than in the TR Band-alone group (4.5% vs. 8.6%; Pg = 0.08) but significantly lower in the PCI subgroup (10.0% vs 24.2%; Pg = 0.04).
The StatSeal group had hematoma rates less than 5 cm (3.1% vs 5.5%) and greater than 5 cm (0.9% vs 1.4%). Radial artery occlusion was low in both groups (0.4% vs. 0.9%), although 41% of patients had less than 5,000 units of unfractionated heparin, he said.
During a press conference that highlighted the results, the study’s co-author, Jordan Safirstein, MD, at Morristown Medical Center, New Jersey, said the hemostatic patch only costs $ 20 to $ 30, but as complications decrease. costs will probably be saved.
“Naturally, it has become our default strategy in a high-volume catalog lab, in which we also have a download room on the same day,” he said.
Session moderator and former SCAI president David Cox, MD, Cardiovascular Associates, Brookwood Baptist Hospital, Birmingham, Alabama, said fundraising is important because about two-thirds of patients treated with the TR band they bleed, which “creates many horah.”
“If you can get your patient home an hour or two earlier, especially people who come from further afield, that may be the difference between an overnight stay and discharge the next morning and discharge at home,” he said. .
Safirstein enthusiastically accepted. “There is no doubt, and it can be launched in late cases: a PCI at 5 o’clock that may require a long hemostasis. With StatSeal, the whole process is formalized and we have fewer staff and fewer doctors who have to go back and check the patient, having to do multiple deflations. It has really simplified our lives. “
They do not normally use the StatSeal patch in patients who have undergone transfemoral procedures, he noted, but it has been used in other situations where bleeding was a problem.
Biolife did not fund the study and did not participate in the design or conduct of the trial. Seto reports on research grants from Philips and Acist and works as a speaker for Terumo, GE and Janssen.
Society for Cardiovascular Angiography and Interventions (SCAI) 2021 Scientific Sessions: Summary FCR-10. Filed April 28, 2021.