title: Vascular complications after transcatheter aortic valve implantation and their association with mortality reevaluated by the valve academic research consortium definitions.
abstract: Vascular complications (VC) after transcatheter aortic valve implantation (TAVI) are reported using various criteria and several access site approaches. We aimed to describe them in a solely percutaneous transfemoral TAVI approach and their association with survival using both the updated Valve Academic Research Consortium (VARC)-2 criteria and the former VARC-1 criteria. From March 2009 to September 2013, 403 consecutive patients at a mean age (±SD) of 83 ± 6 years underwent percutaneous transfemoral TAVI. VC were defined by both VARC-1 and VARC-2 criteria and analyzed separately. Cox proportional hazard ratio models for all-cause mortality were adjusted separately as defined by each criteria. VARC-1-defined and VARC-2-defined VC occurred in 71 (18%) and 78 (19%) patients, respectively, with 15 (4%) and 33 (8%) defined as major VC. The difference in frequency of major and minor VC was mainly driven by VARC-2 implementation of major bleeding events. With either VARC definition, patients with minor VC had similar mortality and complications rates as those patients without VC. In multivariate analyses, referenced to patients with minor or no VC, only VARC-1-defined major VC were significantly associated with increased mortality (hazard ratio 3.52; confidence interval 1.5 to 8.4; p = 0.005), whereas VARC-2-defined major VC were found to be only marginally significant (hazard ratio 1.9; confidence interval 0.9 to 3.9; p = 0.08). In conclusion, the implementation of the VARC-2 criteria resulted in a higher rate of reported major VC after TAVI compared with VARC-1 criteria, mainly by the inclusion of major bleeding events and a reduced association with patient mortality.
authors.affiliation: Department of Cardiology, Tel-Aviv Medical Center, Affiliated to Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel. Electronic address: arikst@tlvmc.gov.il.
authors.forename: Arie
authors.initials: A
authors.lastname: Steinvil
authors.affiliation: Department of Cardiology, Tel-Aviv Medical Center, Affiliated to Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.
authors.forename: Eran
authors.initials: E
authors.lastname: Leshem-Rubinow
authors.affiliation: Department of Cardiology, Tel-Aviv Medical Center, Affiliated to Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.
authors.forename: Amir
authors.initials: A
authors.lastname: Halkin
authors.affiliation: Department of Cardiology, Tel-Aviv Medical Center, Affiliated to Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.
authors.forename: Yigal
authors.initials: Y
authors.lastname: Abramowitz
authors.affiliation: Department of Cardiology, Tel-Aviv Medical Center, Affiliated to Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.
authors.forename: Eyal
authors.initials: E
authors.lastname: Ben-Assa
authors.affiliation: Department of Cardiology, Tel-Aviv Medical Center, Affiliated to Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.
authors.forename: Yacov
authors.initials: Y
authors.lastname: Shacham
authors.affiliation: Department of Vascular Surgery, Tel-Aviv Medical Center, Affiliated to Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.
authors.forename: Avner
authors.initials: A
authors.lastname: Bar-Dayan
authors.affiliation: Department of Cardiology, Tel-Aviv Medical Center, Affiliated to Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.
authors.forename: Gad
authors.initials: G
authors.lastname: Keren
authors.affiliation: Department of Cardiology, Tel-Aviv Medical Center, Affiliated to Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.
authors.forename: Shmuel
authors.initials: S
authors.lastname: Banai
authors.affiliation: Department of Cardiology, Tel-Aviv Medical Center, Affiliated to Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.
authors.forename: Ariel
authors.initials: A
authors.lastname: Finkelstein
mesh_terms: D000047:Academies and Institutes; D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000601:surgery*; D035843:Biomedical Research / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D007557:Israel / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000453:epidemiology*; D011379:Prognosis; D011446:Prospective Studies; D012189:Retrospective Studies; D018570:Risk Assessment / Q000379:methods*; D015996:Survival Rate / Q000639:trends; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects*