title: Propensity-matched comparison between Direct Flow Medical, Medtronic Corevalve, and Edwards Sapien XT prostheses: Device success, thirty-day safety, and mortality.
abstract: OBJECTIVE
  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).
  
  
  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.
authors.affiliation: Contilia Heart and Vascular Center, Elisabeth-Krankenhaus, Essen, Germany.
authors.forename: Yuan
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: Contilia Heart and Vascular Center, Elisabeth-Krankenhaus, Essen, Germany.
authors.forename: Stylianos A
authors.initials: SA
authors.lastname: Pyxaras
authors.affiliation: Contilia Heart and Vascular Center, Elisabeth-Krankenhaus, Essen, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Wolf
authors.affiliation: Contilia Heart and Vascular Center, Elisabeth-Krankenhaus, Essen, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Schmitz
authors.affiliation: Contilia Heart and Vascular Center, Elisabeth-Krankenhaus, Essen, Germany.
authors.forename: Christoph K
authors.initials: CK
authors.lastname: Naber
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000503:physiopathology*; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D017023:Coronary Angiography; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D006439:Hemodynamics; D006801:Humans; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D015999:Multivariate Analysis; D016017:Odds Ratio; D057216:Propensity Score; D011474:Prosthesis Design; D012189:Retrospective Studies; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
keywords: 30-day safety; aortic stenosis; transcatheter aortic valve implantation