title: Single-centre experience with next-generation devices for transapical aortic valve implantation.
abstract: OBJECTIVE
  Transcatheter aortic valve implantation (TAVI) has become an established procedure in patients with aortic stenosis and high surgical risk. Experience with first-generation transcatheter heart valves (THVs) is broad but limitations, e.g. paravalvular regurgitation, have been demonstrated. Much hope rests on the recently Conformité Européenne mark approved next-generation devices to improve results in these patients. However, apart from the initial approval studies, clinical data with these new devices are still scarce. We aimed to assess short-term outcomes of 200 consecutive patients who underwent transapical TAVI with next-generation THV at our institution.
  
  
  METHODS
  Transapical TAVI was performed in 200 consecutive patients 80.5±6.7 years old (38.5% female) at high surgical risk (log EuroSCORE 20.2±16.5%). Devices implanted were the Engager (Medtronic, Inc., Minneapolis, MN, USA; n=50), JenaValve (JenaValve Technology, Munich, Germany; n=88) and Symetis Acurate (Symetis SA, Ecublens, Switzerland; n=62) THV that were selected by the heart team on an individual basis. Data at baseline, during the procedure and follow-up were analysed according to standardized Valve Academic Research Consortium end points. Median follow-up was 219 days.
  
  
  RESULTS
  Implantation was successful in 96.5% of cases. Valve function improved significantly with an increase in effective orifice area from 0.8±0.4 to 1.8±0.3 cm2 and a reduction in mean transvalvalvular gradients from 34.0±17.0 to 11.2±5.4 mmHg. Paravalvular regurgitation was none or trace in 70.3% of patients, Grade 1 in 26.1%, and Grade 2 in 3.5%. No patients developed aortic regurgitation>Grade 2. Major access site complications occurred in 6.5%, major stroke in 1.5% and stage-3 kidney injury in 2.5% of patients. A permanent pacemaker was implanted in 20.5% of patients overall and in 8.0% for a complete heart block. At 30-day follow-up 72.8% of patients were in New York Heart Association class I or II (10.5% at baseline). Overall survival was 91.5% at 30 days and 73.9% at 1 year.
  
  
  CONCLUSIONS
  In a real-world clinical setting, next-generation transapical THV yielded positive haemodynamic results. The incidence of relevant paravalvular regurgitation was scarce in this group and clinical outcomes were encouraging during short-term follow-up. Long-term follow-up is required to investigate the durability of these new devices.
authors.affiliation: Department of General and Interventional Cardiology, University Heart Center Hamburg, Hamburg, Germany m.seiffert@uke.de.
authors.forename: Moritz
authors.initials: M
authors.lastname: Seiffert
authors.affiliation: Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany.
authors.forename: Lenard
authors.initials: L
authors.lastname: Conradi
authors.affiliation: Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Kloth
authors.affiliation: Department of General and Interventional Cardiology, University Heart Center Hamburg, Hamburg, Germany.
authors.forename: Dietmar
authors.initials: D
authors.lastname: Koschyk
authors.affiliation: Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany.
authors.forename: Johannes
authors.initials: J
authors.lastname: Schirmer
authors.affiliation: Department of General and Interventional Cardiology, University Heart Center Hamburg, Hamburg, Germany.
authors.forename: Renate B
authors.initials: RB
authors.lastname: Schnabel
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 of 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: Patrick
authors.initials: P
authors.lastname: Diemert
authors.affiliation: Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany.
authors.forename: Hendrik
authors.initials: H
authors.lastname: Treede
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery; D001022:Aortic Valve Insufficiency / Q000209:etiology; D005260:Female; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D016896:Treatment Outcome
keywords: Engager; JenaValve; Symetis; Transcatheter aortic valve implantation; Transcatheter heart valve