Outcomes
After the peri-procedural heparin protocol was initiated, the initial weight-based bolus of heparin increased from 97±29 units/Kg to 113±29 units/Kg (p<0.001). ACT outcomes are shown in Figure 1. Therapeutic values on first draw increased from 60% in the usual care cohort, to 77% in the protocol guided cohort (Figure 1A, p=0.010). And there was not a significant increase in supra-therapeutic values on first ACT value after heparin administration (Figure 1B, 12% versus 20%, p=0.123). The total proportion of ACT values in therapeutic range during the procedure increased from 79% to 86% with protocol guidance (Figure 1C, OR 1.68, 95% CI 1.24 – 2.28, p=0.001). Supra-therapeutic proportions also did not significantly increase between the usual care and protocol guided cohorts (21% versus 25%, Figure 1D, OR 1.26, 95% CI 0.89 – 1.78, p=0.198).
Time to therapeutic ACT decreased after initiation of the heparin protocol (Figure 2). Time from heparin administration to therapeutic ACT deceased from 37.3±18.8 minutes with usual care, to 31.1±16.4 minutes in the protocol guided cohort (p=0.034). Similarly, time from transspetal access to therapeutic ACT decreased from 30.2±22.3 min with usual care to 19.8±17.3 in the protocol guided cohort (p=0.001).
There was only one major bleeding or thromboembolic event in either cohort, which was a pseudoaneurysm formation with concomitant ipsilateral common femoral vein thrombus identified in the protocol guided cohort.