title: Direct percutaneous transaxillary implantation of a novel self-expandable transcatheter heart valve for aortic stenosis.
abstract: OBJECTIVE
  The aim of this study was to evaluate safety, feasibility, and efficacy of transaxillary TAVI using a novel self-expandable transcatheter heart valve (THV) via a direct percutaneous technique.
  
  
  METHODS
  The analysis comprises 12 consecutive patients with severe aortic stenosis treated with the ACURATE Neo™ THV (Symetis) by direct percutaneous transaxillary access.
  
  
  RESULTS
  Patients presented with a mean age of 79.9 ± 6.2 years and high calculated surgical risk (logEuroSCORE I: 19.55 ± 15.00%; STS PROM score: 5.42 ± 3.25%). Transaxillary TAVI was performed in 11/12 via the left and in 1/12 via the right-sided axillary artery. Device success was achieved in all patients (12/12). Mortality rate at 30 days was 0% (0/12). No major and one minor access site complication (1/12) occurred. No major or life-threatening access site-related bleeding resulted. None of the patients suffered from postprocedural stroke/transient ischemic attack. There was no need for a permanent pacemaker. Mean effective orifice area post implantation was 2.1 ± 0.29 cm2and mean aortic gradient 6.2 ± 1.5 mm Hg. In none of the patients, greater than moderate aortic regurgitation or paravalvular leakage was detected at discharge (0/12).
  
  
  CONCLUSIONS
  Our study suggests that the implantation of the second-generation self-expandable ACURATE Neo™ via a transaxillary access is technically feasible and safe and yields excellent short-term clinical results. © 2017 Wiley Periodicals, Inc.
authors.affiliation: Department of General and Interventional Cardiology, University Heart Center Hamburg, Hamburg, Germany.
authors.forename: Florian
authors.identifier: http://orcid.org/0000-0003-2148-9303
authors.initials: F
authors.lastname: Deuschl
authors.affiliation: Department of General and Interventional Cardiology, University Heart Center Hamburg, Hamburg, Germany.
authors.forename: Niklas
authors.identifier: http://orcid.org/0000-0001-5190-813X
authors.initials: N
authors.lastname: Schofer
authors.affiliation: Department of General and Interventional Cardiology, University Heart Center Hamburg, Hamburg, Germany.
authors.forename: Moritz
authors.initials: M
authors.lastname: Seiffert
authors.affiliation: Department for Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany.
authors.forename: Samer
authors.initials: S
authors.lastname: Hakmi
authors.affiliation: Department of General and Interventional Cardiology, University Heart Center Hamburg, Hamburg, Germany.
authors.forename: Isamu
authors.initials: I
authors.lastname: Mizote
authors.affiliation: Department for Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Schaefer
authors.affiliation: Department for Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany.
authors.forename: Johannes
authors.initials: J
authors.lastname: Schirmer
authors.affiliation: Department for Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany.
authors.forename: Hermann
authors.initials: H
authors.lastname: Reichenspurner
authors.affiliation: Department of General and Interventional Cardiology, University Heart Center Hamburg, Hamburg, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Blankenberg
authors.affiliation: Department for Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany.
authors.forename: Lenard
authors.initials: L
authors.lastname: Conradi
authors.affiliation: Department of General and Interventional Cardiology, University Heart Center Hamburg, Hamburg, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Schäfer
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001022:Aortic Valve Insufficiency / Q000209:etiology; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D001366:Axillary Artery / Q000000981:diagnostic imaging; D002406:Catheterization, Peripheral / Q000009:adverse effects / Q000379:methods*; D000072226:Computed Tomography Angiography; D017023:Coronary Angiography / Q000379:methods; D016208:Databases, Factual; D017548:Echocardiography, Transesophageal; D005240:Feasibility Studies; D005260:Female; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D061330:Multidetector Computed Tomography; D011474:Prosthesis Design; D011475:Prosthesis Failure; D011677:Punctures; D012189:Retrospective Studies; D012720:Severity of Illness Index; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D016896:Treatment Outcome
keywords: TAVI; THV; alternative access; transaxillary access