Key result
The Medtronic Plus ACT device demonstrated correlation coefficients of R2=0.576 (high-range) and R2=0.806 (low-range) compared with the Hemochron 401 ACT device during PCI.
Why the study?
Does the Medtronic Plus ACT device provide comparable activated clotting times to the Hemochron 401 ACT device in patients receiving unfractionated heparin during percutaneous coronary intervention?
Observational
Does the Medtronic Plus ACT device provide comparable activated clotting times to the Hemochron 401 ACT device in patients receiving unfractionated heparin during percutaneous coronary intervention?
Effect estimate: R2 = 0.576 (HRC) and R2 = 0.806 (LRC)
Activated clotting time measurements during percutaneous coronary intervention vary significantly depending on the point-of-care technology used, necessitating proper quality assurance when introducing new devices.
May not support interchangeable ACT use between devices in PCI; leaves open need for device-specific validation and quality controls.
To introduce the Medtronic Plus ACT device (Medtronic, Minneapolis, Minn) into practice, we compared the activated clotting times (ACTs) obtained from the Medtronic Plus ACT device with those obtained from the Hemochron 401 ACT device (International Technidyne Corp, Edison, NJ) in patients undergoing percutaneous coronary intervention. Patients undergoing cardiac catheterization who received unfractionated heparin provided blood at one or more arbitrarily selected time points during their procedure. The ACTs were obtained from the Hemochron 401 using Celite 510 tubes and simultaneously from the Medtronic Plus using either a low-range cartridge (LRC) or high-range cartridge (HRC). Data were divided into 2 groups for analysis based on which cartridge was used in the Medtronic device (ie, LRC or HRC). Linear regression lines and Bland-Altman plots were constructed comparing ACTs from the Hemochron device with those obtained from each Medtronic LRC and HRC groups. The correlation coefficients for both the HRC and LRC regression lines were R2 = 0.576 and R2 = 0.806, respectively. The Bland-Altman plots demonstrated a smaller, but more variable, bias with the HRC compared with the LRC. The ACT obtained during percutaneous coronary intervention in patients receiving unfractionated heparin is dependent on what technology is used. When laboratories introduce new technology to measure ACTs and guide therapy, proper quality assurance should be performed to minimize the risks of anticoagulation.
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Arpino et al. (2008) conducted an observational in Percutaneous coronary intervention. Medtronic Plus ACT device vs. Hemochron 401 ACT device was evaluated on Activated clotting times (ACTs) (R2 = 0.576 (HRC) and R2 = 0.806 (LRC)). The Medtronic Plus ACT device demonstrated correlation coefficients of R2=0.576 (high-range) and R2=0.806 (low-range) compared with the Hemochron 401 ACT device during PCI.
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