title: Low permanent pacemaker rates following Lotus device implantation for transcatheter aortic valve replacement due to modified implantation protocol.
abstract: BACKGROUND
  Conduction disturbances requiring permanent pacemaker implantation following transcatheter aortic valve replacement (TAVR) are a common problem. Pacemaker implantation rates after TAVR appear to be higher compared to conventional aortic valve replacement. The aim of this study was to analyze whether a high annulus implantation conveys the benefit of a decreased rate of permanent pacemaker implantation while being safe and successful according to Valve Academic Research Consortium 2 (VARC2)-criteria.
  
  
  METHODS
  A total of 23 patients with symptomatic severe aortic valve stenosis, an aortic annulus of 19-27 mm and at high risk for surgery were treated with the Lotus valve. In all patients the valve was implanted in a high annulus position via femoral access. The primary device performance endpoint was VARC2-defined device success after 30 days and the primary safety endpoint was the need for permanent pacemaker implantation.
  
  
  RESULTS
  The mean age was 73.23 ± 7.65 years, 46% were female, 38% were New York Heart Association class III/IV at baseline. Thirty-day follow-up data were available for all patients. The VARC2-defined device success rate after 30 days was 22/23 (96%). 2/21 (10%) patients required a newly implanted pacemaker due to 3rd degree atrioventricular block. 25% of the patients developed a new left bundle branch block after valvuloplasty or device implantation. 21 of the 23 patients (96%) had no other signs of conduction disturbances after 30 days.
  
  
  CONCLUSIONS
  The approach of the modified implantation technique of Lotus TAVR device was safe and effective. The incidence of need for a permanent pacemaker following TAVR could be significantly reduced due to adopted implantation protocol.
authors.affiliation: Department of Cardiology, Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Berlin, Germany, Germany. florian.krackhardt@charite.de.
authors.forename: Florian
authors.initials: F
authors.lastname: Krackhardt
authors.forename: Behrouz
authors.initials: B
authors.lastname: Kherad
authors.forename: Maximilian
authors.initials: M
authors.lastname: Krisper
authors.forename: Burkert
authors.initials: B
authors.lastname: Pieske
authors.forename: Michael
authors.initials: M
authors.lastname: Laule
authors.forename: Carsten
authors.initials: C
authors.lastname: Tschöpe
mesh_terms: D000368:Aged; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000601:surgery*; D054537:Atrioventricular Block / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D004562:Electrocardiography; D005260:Female; D005858:Germany / Q000453:epidemiology; D006350:Heart Valve Prosthesis; D006801:Humans; D015994:Incidence; D008297:Male; D010138:Pacemaker, Artificial; D011379:Prognosis; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012307:Risk Factors; D012720:Severity of Illness Index; D015996:Survival Rate / Q000639:trends; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects* / Q000295:instrumentation; D016896:Treatment Outcome
keywords: aortic stenosis; atrioventricular block; conduction disturbances; permanent pacemaker; transcatheter aortic valve replacement