Key result
Edwards Sapien TAVR linked to ~165% higher incidence of new thrombocytopenia vs BAV.
Why the study?
Does TAVR with Sapien valves increase the incidence of thrombocytopenia compared to BAV in patients undergoing aortic valve procedures?
Cohort (n=217)
No
Does TAVR with Sapien valves increase the incidence of thrombocytopenia compared to BAV in patients undergoing aortic valve procedures?
Absolute Event Rate: 45% vs 17%
p-value: p=< 0.01
Thrombocytopenia following TAVR with Edwards Sapien valves is a frequent but generally self-limited process that resolves spontaneously around 8 days post-procedure, with no major differences in clinical outcomes other than increased blood product use.
Requires platelet monitoring after Sapien TAVR; hypothesis-generating for comparative risks versus BAV and need for RCTs.
OBJECTIVES: To determine the incidence and etiology of thrombocytopenia following transcatheter Aortic valve replacement (TAVR). BACKGROUND: the use of TAVR in the United States has grown rapidly. Anecdotally, thrombocytopenia following TAVR with the Sapien valves has been observed, though little is known about this phenomenon. METHODS: All patients treated with TAVR using a Sapien valve or who underwent isolated balloon aortic valvuloplasty (BAV) at Brigham and Women's Hospital from October 2009 through November 2012 were analyzed. Post-procedure thrombocytopenia severity was stratified as none (>150,000 cells/μL), mild (100-150,000), and moderate to severe (<100,000). Summary statistics and simple comparisons were evaluated. Linear regression models were used to identify patient or procedural factors associated with platelet count nadir. RESULTS: 112 TAVR and 105 BAV patients were analyzed. Following TAVR the prevalence of thrombocytopenia was 69% and the incidence of new thrombocytopenia was 45% compared to 37% and 17% respectively following BAV (P < 0.01). Similar results were found across all strata of thrombocytopenia severity. Post-TAVR platelet nadirs were greater by 1,840 cells/μL for each 1% increase in STS score (P = 0.03) and 670 cells/μL greater for each 1 mmHg increase in pre-TAVR mean aortic stenosis gradient. Among TAVR patients, thrombocytopenia appears to spontaneously resolve an average of 8 days post-procedure. No differences in clinical outcomes based on thrombocytopenia severity were observed except for an increased use of blood products (P = 0.05). CONCLUSIONS: Thrombocytopenia following TAVR with the Edwards' Sapien valves is a frequent but generally self-limited process. The etiology of this phenomenon is unknown.
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McCabe et al. (2013) conducted a cohort in Aortic stenosis (n=217). Transcatheter aortic valve replacement (TAVR) with Edwards Sapien valve vs. Balloon aortic valvuloplasty (BAV) was evaluated on Incidence of new thrombocytopenia (p=< 0.01). Transcatheter aortic valve replacement with the Edwards Sapien valve was associated with a higher incidence of new thrombocytopenia compared to balloon aortic valvuloplasty (45% vs 17%, P<0.01).
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