title: Applicability of next generation balloon-expandable transcatheter heart valves in aortic annuli exceeding formally approved dimensions.
abstract: OBJECTIVE
  Physicians are frequently confronted with patients suffering from aortic stenosis with annular diameters exceeding dimensions in which currently available transcatheter heart valves (THV) are formally approved. Experience in patients receiving significantly undersized Sapien 3 (S3) THV (Edwards Lifesciences, Inc., Irvine, CA, USA) in aortic annuli up to 32 mm has not been reported so far.
  
  
  METHODS
  Patients with aortic annuli exceeding the formally determined upper size limit and who received a 29 mm S3, were identified from our database. Calcification pattern and annulus dimension were analyzed retrospectively using the 3mensio Medical Imaging software. Clinical endpoints were adjudicated in accordance with the updated standardized VARC-2 definitions.
  
  
  RESULTS
  21 consecutive patients with aortic annuli ≥28.1 mm received a 29 mm THV. All patients were male (77.4 ± 8.1 year, logEuroSCORE I 22.5 ± 14.1 %). Multi-slice computed tomography and transesophageal echocardiography derived annular dimensions were 30.2 ± 1.5 vs. 28.8 ± 0.9 mm (p = 0.0001). Total calcium load of the aortic valves was 1327 ± 957 mm(3). Device success according to VARC-2 definitions was achieved in 100 % (21/21). All-cause 30-day mortality was 0 % (0/21). Rate of permanent pacemaker implantation was 14.3 % (3/21). No paravalvular leakage ≥ grade II was detectable.
  
  
  CONCLUSIONS
  Preliminary experience suggests implantation of this type of THV in aortic annuli up to 32 mm to be feasible and safe, in particular calcification patterns. It does not result in a relevant incidence of PVL ≥ grade II, or increased rate of VARC-2 adjudicated clinical endpoints. Also, functional outcomes regarding transvalvular gradients or EOA demonstrate applicability of this THV in such patients.
authors.affiliation: Department of Cardiovascular Surgery, University Heart Center Hamburg, Martinistraße 52, 20246, Hamburg, Germany. and.schaefer@uke.de.
authors.forename: Andreas
authors.initials: A
authors.lastname: Schaefer
authors.affiliation: Department of Cardiovascular Surgery, University Heart Center Hamburg, Martinistraße 52, 20246, Hamburg, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Linder
authors.affiliation: Department of Cardiac and Thoracic Surgery, University Hospital Halle, Ernst-Grube-Straße 40, 06120, Halle (Saale), Germany.
authors.forename: Hendrik
authors.initials: H
authors.lastname: Treede
authors.affiliation: Department of General and Interventional Cardiology, University Heart Center Hamburg, Martinistraße 52, 20246, Hamburg, Germany.
authors.forename: Florian
authors.initials: F
authors.lastname: Deuschl
authors.affiliation: Department of General and Interventional Cardiology, University Heart Center Hamburg, Martinistraße 52, 20246, Hamburg, Germany.
authors.forename: Niklas
authors.initials: N
authors.lastname: Schofer
authors.affiliation: Department of General and Interventional Cardiology, University Heart Center Hamburg, Martinistraße 52, 20246, Hamburg, Germany.
authors.forename: Moritz
authors.initials: M
authors.lastname: Seiffert
authors.affiliation: Department of Cardiovascular Surgery, University Heart Center Hamburg, Martinistraße 52, 20246, Hamburg, Germany.
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Schneeberger
authors.affiliation: Department of General and Interventional Cardiology, University Heart Center Hamburg, Martinistraße 52, 20246, Hamburg, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Blankenberg
authors.affiliation: Department of Cardiovascular Surgery, University Heart Center Hamburg, Martinistraße 52, 20246, Hamburg, Germany.
authors.forename: Hermann
authors.initials: H
authors.lastname: Reichenspurner
authors.affiliation: Department of General and Interventional Cardiology, University Heart Center Hamburg, Martinistraße 52, 20246, Hamburg, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Schaefer
authors.affiliation: Department of Cardiovascular Surgery, University Heart Center Hamburg, Martinistraße 52, 20246, Hamburg, Germany.
authors.forename: Lenard
authors.initials: L
authors.lastname: Conradi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000473:pathology* / Q000503:physiopathology; D001022:Aortic Valve Insufficiency / Q000209:etiology; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D001145:Arrhythmias, Cardiac / Q000209:etiology / Q000628:therapy; D063126:Balloon Valvuloplasty / Q000009:adverse effects; D002114:Calcinosis / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D002304:Cardiac Pacing, Artificial; D016208:Databases, Factual; D017548:Echocardiography, Transesophageal; D005240:Feasibility Studies; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D006801:Humans; D021621:Imaging, Three-Dimensional; D008297:Male; D061330:Multidetector Computed Tomography; D010138:Pacemaker, Artificial; D011237:Predictive Value of Tests; D011474:Prosthesis Design; D011857:Radiographic Image Interpretation, Computer-Assisted; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome
keywords: Aortic annulus; MSCT; TAVI; TEE; THV