open access

Vol 24, No 3 (2017)
Original articles — Interventional cardiology
Published online: 2017-02-15
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Low permanent pacemaker rates following Lotus device implantation for transcatheter aortic valve replacement due to modified implantation protocol

Florian Krackhardt, Behrouz Kherad, Maximilian Krisper, Burkert Pieske, Michael Laule, Carsten Tschöpe
DOI: 10.5603/CJ.a2017.0024
·
Pubmed: 28248410
·
Cardiol J 2017;24(3):250-258.

open access

Vol 24, No 3 (2017)
Original articles — Interventional cardiology
Published online: 2017-02-15

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.

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.

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Keywords

aortic stenosis, transcatheter aortic valve replacement, permanent pacemaker, conduction disturbances, atrioventricular block

About this article
Title

Low permanent pacemaker rates following Lotus device implantation for transcatheter aortic valve replacement due to modified implantation protocol

Journal

Cardiology Journal

Issue

Vol 24, No 3 (2017)

Pages

250-258

Published online

2017-02-15

DOI

10.5603/CJ.a2017.0024

Pubmed

28248410

Bibliographic record

Cardiol J 2017;24(3):250-258.

Keywords

aortic stenosis
transcatheter aortic valve replacement
permanent pacemaker
conduction disturbances
atrioventricular block

Authors

Florian Krackhardt
Behrouz Kherad
Maximilian Krisper
Burkert Pieske
Michael Laule
Carsten Tschöpe

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