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Randomized Controlled Trial
. 2018 Mar 20;8(1):4870.
doi: 10.1038/s41598-018-23209-5.

Pacemaker Implantation Associated Myocardial Micro-Damage: A Randomised Comparison between Active and Passive Fixation Leads

Patrick Blažek  1 , Jerko Ferri-Certić  2 , Hrvoje Vražić  3 , Carsten Lennerz  4   5 , Christian Grebmer  4 , Kazuaki Kaitani  6 , Martin Karch  7 , Boris Starčević  3 , Verena Semmler  4 , Christof Kolb  4
Affiliations
Randomized Controlled Trial

Pacemaker Implantation Associated Myocardial Micro-Damage: A Randomised Comparison between Active and Passive Fixation Leads

Patrick Blažek et al. Sci Rep. .

Abstract

Fixation of the pacemaker leads during pacemaker implantation leads to an increase of cardiac Troponin T (cTnT) that can be interpreted as a sign of minimal myocardial damage. This trial evaluates whether the mechanism type of lead fixation influences the magnitude of cTnT release. Patients having a de-novo cardiac pacemaker implantation or a lead revision were centrally randomized to receive either a ventricular lead with an active (screw) or passive (tine) fixation mechanism. High-sensitive Troponin T (hsTnT) was determined on the day of the procedure beforehand and on the following day. 326 Patients (median age (IQR) 75.0 (69.0-80.0) years, 64% male) from six international centers were randomized to receive ventricular leads with an active (n = 166) or passive (n = 160) fixation mechanism. Median (IQR) hsTnT levels increased by 0.009 (0.004-0.021) ng/ml in the group receiving screw-in ventricular leads and by 0.008 (0.003-0.030) ng/ml in the group receiving tined ventricular leads (n.s.). In conclusion pacemaker implantations are followed by a release of hsTnT. The choice between active or passive fixation ventricular leads does not have a significant influence on the extent of myocardial injury and the magnitude of hsTnT release.

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Conflict of interest statement

Patrick Blažek, Jerko Ferri-Certić, Christian Grebmer, Kazuaki Kaitani and Boris Starčević declare no potential conflict of interest. Hrvoje Vražić was supported by a training fellowship provided by the European Heart Rhythm Association. As of 01/2017, he is working at Novo Nordisk, Copenhagen, Denmark. Carsten Lennerz has received lecture fees from Biotronik and travel support from St. Jude Medical, Sorin Group and Biotronik. Martin Karch or his spouse/partner have received lecture fees from Bayer Vital and took part in clinical trials that were supported by Medtronic and LIVANOVA. Verena Semmler has received travel support from Sorin Group, Boston Scientific and St. Jude Medical. Christof Kolb has received lecture honoraria/travel support from Biotronik, Boston Scientific, Medtronic, Sorin Group, Spectranetics and St. Jude Medical. He has been a consultant to Biotronik, Boston Scientific and Sorin Group. He has performed clinical studies supported by Biotronik, Medtronic, Boston Scientific, Sorin Group, and St. Jude Medical.

Figures

Figure 1
Figure 1
Study flow diagram.
Figure 2
Figure 2
Absolute difference of troponin levels (ΔhsTnT) in the groups with active and passive fixation ventricular leads (a single outlier in the group with active fixation ventricular leads with ΔhsTnT = 0.297 ng/ml is excluded). hsTnT = High-sensitive Troponin T.
See this image and copyright information in PMC

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