title: Incidence, Predictors and Impact of Severe Periprocedural Bleeding According to VARC-2 Criteria on 1-Year Clinical Outcomes in Patients After Transcatheter Aortic Valve Implantation.
abstract: There are differences in reporting bleeding complications after transcatheter aortic valve implantation (TAVI), which is a consequence of the lack of consensus for their definition. Furthermore, the amount of data on the impact of peri-procedural bleeding on the mid-term prognosis is still limited. The aim of this study was to investigate the incidence, predictors, and impact of life-threatening and major bleedings as defined by the Valve Academic Research Consortium 2 (VARC-2) in patients after TAVI over the mid-term prognosis.Consecutive patients who underwent TAVI from March 2010 to December 2013 were included. All data were classified according to the VARC-2 criteria. We assessed the incidence and the predictors of serious bleeding events (SBE), defined as life-threatening/disabling (LT/D) or major bleeding, and analyzed their impact on 30-day and 1-year clinical outcome.A total of 129 patients were included (79.1 ± 8.3 years; mean EuroSCORE = 17.8 ± 12.7). The SBE occurred in 25 patients (19.4%), of which 9 (7.0%) had LT/D and 16 (12.4%) had major bleeding. Trans-subclavian (TS) access (OR 4.38, 95% CI 2.13-14.29, P = 0.01) and diabetes (OR 2.93, 95% CI 1.08-7.93, P = 0.03) were identified as independent predictors of SBE. Patients with SBE had higher 30-day mortality (20.0% versus 4.0% P = 0.02) and 1-year mortality (40.0% versus 11.1%, P < 0.002). SBE independently predicted 1-year, all-cause mortality (HR 5.88, 95% CI 1.7319,94, P = 0.005).SBE are frequent after TAVI and are associated with decreased short and mid-term survival. Diabetes and TS access are independent risk factors for SBE.
authors.affiliation: 1st Department of Cardiology, Medical University of Warsaw.
authors.forename: Janusz
authors.initials: J
authors.lastname: Kochman
authors.forename: Bartosz
authors.initials: B
authors.lastname: Rymuza
authors.forename: Zenon
authors.initials: Z
authors.lastname: Huczek
authors.forename: Łukasz
authors.initials: Ł
authors.lastname: Kołtowski
authors.forename: Piotr
authors.initials: P
authors.lastname: Ścisło
authors.forename: Radosław
authors.initials: R
authors.lastname: Wilimski
authors.forename: Anna
authors.initials: A
authors.lastname: Ścibisz
authors.forename: Paulina
authors.initials: P
authors.lastname: Stanecka
authors.forename: Krzysztof J
authors.initials: KJ
authors.lastname: Filipiak
authors.forename: Grzegorz
authors.initials: G
authors.lastname: Opolski
mesh_terms: D001024:Aortic Valve Stenosis / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008279:Magnetic Resonance Imaging; D008297:Male; D011044:Poland / Q000453:epidemiology; D019106:Postoperative Hemorrhage / Q000175:diagnosis / Q000453:epidemiology* / Q000209:etiology; D011379:Prognosis; D011446:Prospective Studies; D012189:Retrospective Studies; D012307:Risk Factors; D012720:Severity of Illness Index; D015996:Survival Rate / Q000639:trends; D014057:Tomography, X-Ray Computed; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects*