The Direct Flow Medical prosthesis demonstrated a higher 30-day safety rate compared to Medtronic Corevalve and Edwards Sapien XT (95.0% vs. 67.5% vs. 82.5%; P=0.006) in patients undergoing TAVI.
Observational (n=120)
Does TAVI with the Direct Flow Medical prosthesis improve 30-day safety compared to Medtronic Corevalve and Edwards Sapien XT in high-risk patients with severe aortic stenosis?
In high-risk patients with severe aortic stenosis, TAVI with the Direct Flow Medical prosthesis demonstrated a significantly higher 30-day VARC-2 safety rate compared to Medtronic Corevalve and Edwards Sapien XT, primarily driven by fewer major vascular complications.
p-value: p=0.006
AIMS: To compare 30-day performance of three different type of transcatheter aortic valve implantation (TAVI) prosthesis: Direct Flow Medical (DFM), Medtronic Corevalve (MCV), and Edwards Sapien XT (ES). METHODS AND RESULTS: Forty consecutive patients treated with DFM for severe aortic stenosis were matched to an equal sample of patients undergoing TAVI with MCV and ES (1:1:1 propensity score-matching). Primary end-point was 30-day safety, defined according to the valve academic research consortium (VARC-2) criteria. Secondary end-points were: (i) immediate post-TAVI transaortic gradient reduction, (ii) device success, and (iii) 30-day mortality. Patients treated with DFM had higher 30-day safety rate compared to MCV and ES (respectively: 95.0% vs. 67.5% vs. 82.5%; P=0.006). Immediate post-TAVI, transaortic gradient reduction was similar for DFM, MCV, and ES subgroups (respectively: 8.3 ± 5.2 mm Hg vs. 5.3 ± 3.7 mm Hg vs. 5.6 ± 5.1 mm Hg; P=0.15); likewise, device success did not differ significantly (respectively: 100% vs. 92.5% vs. 92.5%; P=0.19). Mortality rates were also similar (respectively: 0% vs. 7.5% vs. 7.5%; P=0.190). In the pooled binary logistic regression analysis, blood transfusion was associated to 30-day safety (HR 0.156, 95% CI 0.049-0.500, P=0.002), while a significant trend was observed for the vascular closure device type (favoring Proglide vs. Prostar: HR 0.239, 95% CI 0.049-1.160, P=0.076). CONCLUSIONS: In high-risk patients with aortic stenosis undergoing TAVI, device success and short-term mortality were comparable between DFM, MCV, and ES. In contrast, the 30-day VARC-defined safety primary end-point was met significantly more frequently in patients treated with DFM. This result was mainly driven by differences in major vascular complications, associated to differences in vascular closure devices between the different valve subgroups.
Zhang et al. (Sat,) conducted a observational in severe aortic stenosis (n=120). Direct Flow Medical (DFM) prosthesis vs. Medtronic Corevalve (MCV) and Edwards Sapien XT (ES) prostheses was evaluated on 30-day safety (VARC-2 criteria) (p=0.006). The Direct Flow Medical prosthesis demonstrated a higher 30-day safety rate compared to Medtronic Corevalve and Edwards Sapien XT (95.0% vs. 67.5% vs. 82.5%; P=0.006) in patients undergoing TAVI.
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