Key result
Freedom Solo bioprosthesis implantation during aortic valve replacement was associated with a higher incidence of thrombocytopenia compared to other biological valves (24.1% vs 4.4%, p<0.0001).
Why the study?
Does the Freedom Solo bioprosthesis increase the risk of thrombocytopenia compared to other biological valves in patients undergoing isolated biological aortic valve replacement?
Cohort (n=322)
Does the Freedom Solo bioprosthesis increase the risk of thrombocytopenia compared to other biological valves in patients undergoing isolated biological aortic valve replacement?
Absolute Event Rate: 24.1% vs 4.4%
p-value: p=<0.0001
The Freedom Solo bioprosthesis is associated with a significantly higher risk of postoperative thrombocytopenia and platelet activation compared to other biological valves, though without apparent adverse clinical events.
Thrombocytopenia risk with Freedom Solo warrants platelet monitoring but should not yet change valve selection; leaves open clinical impact and need for prospective trials.
OBJECTIVE: The risk of thrombocytopenia in patients undergoing aortic valve replacement (AVR) with the Freedom Solo (FS) bioprosthesis is controversial. The aim of our study was to evaluate the postoperative evolution of platelet count and function after AVR in patients undergoing isolated biological AVR with FS. METHODS: Between May 2005 and June 2010, 322 patients underwent isolated biological AVR. Of these, 116 patients received FS and were compared with 206 patients who received biological valves. Platelet count, mean platelet volume (MPV), and platelet distribution width (PDW) were evaluated at baseline (T0), first (T1), second (T2), and fifth (T3) postoperative days, respectively. RESULTS: Overall in-hospital mortality was 1.5% with no difference between the two groups. Thirty-seven (11.5%) patients developed thrombocytopenia. FS implantation was associated with a higher incidence of thrombocytopenia compared with the control group (24.1% vs 4.4%, p<0.0001). Patients in the FS group showed a lower platelet count than the control group at T1 (99.4±38×10(3) μl(-1) vs 122.5±41.6×10(3) μl(-1), p<0.001), T2 (79.7±36.3×10(3) μl(-1) vs 122.5±43.3×10(3) μl(-1), p<0.001) and T3 (86.6±57.4×10(3) μl(-1) vs 158.4±55.8×10(3) μl(-1), p<0.001). Moreover, the FS group also had a higher MPV (11.6±0.9 fl vs 11±1 fl, p<0.001) and higher PDW (15.1±2.3 fl vs 13.9±2.1 fl, p<0.001) at T3. In a multivariable analysis, FS (p<0.0001), body surface area (p<0.0001), cardiopulmonary bypass time (p=0.003), and lower preoperative platelet counts (p=0.006) were independent predictors of thrombocytopenia. CONCLUSIONS: The FS valve might increase the risk of thrombocytopenia and platelet activation, in the absence of adverse clinical events. Prospective randomized studies on platelet function need to confirm our data.
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Miceli et al. (2011) conducted a cohort in Isolated biological aortic valve replacement (n=322). Freedom Solo bioprosthesis vs. Other biological valves was evaluated on Incidence of thrombocytopenia (p=<0.0001). Freedom Solo bioprosthesis implantation during aortic valve replacement was associated with a higher incidence of thrombocytopenia compared to other biological valves (24.1% vs 4.4%, p<0.0001).
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