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Long-term performance of an atrial lead capable of accelerometer based detection of cardiac contractility in patients receiving cardiac resynchronisation therapy


Autoři: Thomas Senoner aff001;  Fabian Barbieri aff001;  Georg Semmler aff002;  Agne Adukauskaite aff001;  Andrea Rubatscher aff001;  Wilfried Schgör aff001;  Markus Stühlinger aff001;  Axel Bauer aff001;  Bernhard Erich Pfeifer aff004;  Lukas Fiedler aff006;  Franz Xaver Roithinger aff006;  Florian Hintringer aff001;  Alois Suessenbacher aff007;  Christian Georg Wollmann aff002;  Wolfgang Dichtl aff001
Působiště autorů: University Clinic of Internal Medicine III (Cardiology and Angiology), Medical University Innsbruck, Innsbruck, Austria aff001;  Department of Internal Medicine III, University Clinic St. Pölten, St. Pölten, Austria aff002;  Karl Landsteiner University, St. Pölten, Austria aff003;  Landesinstitut für Integrierte Versorgung, Tirol Kliniken GmbH, Innsbruck, Austria aff004;  Austrian Institute of Technology, Center for Health & Bioresources, Digital Health Information Systems, Eduar Wallnöfer Zentrum 1, Hall in Tirol, Austria aff005;  Landesklinikum Wiener Neustadt, Department of Internal Medicine III, Wiener Neustadt, Austria aff006;  St. Vinzenz Hospital, Department of Internal Medicine, Zams, Austria aff007
Vyšlo v časopise: PLoS ONE 14(9)
Kategorie: Research Article
doi: https://doi.org/10.1371/journal.pone.0222269

Souhrn

Objectives

To evaluate the long-term performance of the SonRtip atrial lead.

Background

To optimize atrioventricular and interventricular timing and thereby potentially improving cardiac resynchronization therapy (CRT) responder rates, a lead integrated technology and a cardioverter/defibrillator-based algorithm measuring peak endocardial acceleration have been introduced. Long-term performance of the atrial lead (SonRtip PS55D, Sorin/MicroPort CRM, Italy) embedded with such a sensor has not been reported so far.

Methods

Between 2012 and 2018, 143 patients underwent implantation of the SonRtip atrial lead in four Austrian medical centers. Conventional bipolar atrial leads implanted during the same period in 526 patients receiving CRT were used as control cohort.

Results

Among 669 patients included in the study, 10 (1.5%) showed increased atrial pacing thresholds and/or decreased atrial sensing amplitudes and/or sudden increase in atrial lead impedance (above 3000 Ω) after an uneventful early postoperative period. Seven (70%) of the malfunctioning leads were SonRtip leads (p <0.001). Lead replacement was needed in 4.2% of SonRtip leads (six out of 143) and in 0.38% of all other conventional atrial leads (two out of 526) (p <0.001). Because of unaltered atrial sensing properties, a wait and see strategy was chosen in two patients–one of them with a SonRtip lead. The implanted atrial lead in the latter person experienced a sudden increase in pacing threshold (4V/0.35ms).

Conclusions

While short-term safety and stable technical performance of the SonRtip atrial lead could be confirmed, our study found an unexpectedly high malfunction rate over a longer follow-up period.

Klíčová slova:

Biology and life sciences – Bioengineering – Biotechnology – Medical devices and equipment – Medical implants – Pacemakers – Engineering and technology – Electronics – Electrodes – Medicine and health sciences – Cardiology – Cardiac pacing – Physical sciences – Mathematics – Optimization – Applied mathematics – Algorithms – Research and analysis methods – Simulation and modeling


Zdroje

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3. Ritter P, Delnoy PPH, Padeletti L, Lunati M, Naegele H, Borri-Brunetto A, et al. A randomized pilot study of optimization of cardiac resynchronization therapy in sinus rhythm patients using a peak endocardial acceleration sensor vs. standard methods. Europace. 2012;14: 1324–1333. doi: 10.1093/europace/eus059 22549295

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7. Schwarzwald SN, Kersten DJ, Shaikh ZA, Needelman BS, Feldman AM, Germano J, et al. Mechanisms of Lead Failure by Recall Status and Manufacturer: Results From the Pacemaker and Implantable Defibrillator Leads Survival Study (“PAIDLESS”). J Invasive Cardiol. 2018;30: 147–151. 29610446

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