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Clinical routine implantation of a dual chamber pacemaker system designed for safe use with MRI

A single center, retrospective study on lead performance of Medtronic lead 5086MRI in comparison to Medtronic leads 4592–53 and 4092–58

Implantation eines MR-tauglichen DDD-Schrittmachersystems in der klinischen Routine

Resultate einer retrospektiven Studie zum Verhalten der Medtronic-Elektrode 5086MRI im Vergleich zu den Medtronic-Elektroden 4592–53 und 4092–58

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Herzschrittmachertherapie + Elektrophysiologie Aims and scope Submit manuscript

Abstract

Aims

We report our experience concerning lead performance and re-surgery rate of the Medtronic EnRhythm MRI SureScan pacemaker system (MRI-PM) in comparison to standard pacemaker (PM) systems and leads used at our institution.

Methods

All patients (except patients with transvenous left ventricular leads) with successful PM implantation performed at our institution from 1 March 2009 to 31 October 2009 were included in this analysis and followed until mid January 2010. Lead measurements (assessed at implantation, prehospital discharge interrogation (1st follow-up) and at the first scheduled out-patient follow-up (2nd follow-up) were compared between atrial leads 4592–53 cm and 5086MRI–52 cm (lead group 1), and between ventricular leads 4092–58 cm and 5086MRI–52 cm/-58 cm (lead group 2), respectively. Causes for re-operations were assessed and compared between patients with standard dual chamber PM (DC-PM) and the MRI-PM.

Results

A total of 140 patients (VVI-PM: 36 patients; DDD-PM: 102 patients; biventricular PM: 1 patient) were successfully implanted with a PM within the implantation period. Two patients with transvenous left ventricular leads were excluded from further analysis. In an atrial position, lead 4592 was implanted in 51 patients and lead 5086MRI–52 cm was implanted in 40 patients, respectively. Ventricular leads were lead 4092–58 cm (64 patients) and lead 5086MRI (41 patients), respectively. Patients were followed for 26 ± 11 weeks. Comparison of lead measurements of lead group 1 showed significant differences for pacing impedance and pacing threshold at implantation, and for sensing at the 2nd follow-up. Comparison of lead measurements within lead group 2 showed significant differences for pacing impedance at implantation, for pacing threshold at the 1st follow-up, and for sensing, pacing threshold, and impedance at the 2nd follow-up. All assessed mean values were favorable for all leads at any follow-up. The number of re-operations was high in both dual chamber PM groups, but did not differ significantly between the two groups (DC-PM: 5 patients, 8.5%; MRI-PM: 5 patients, 13.2%).

Conclusion

Our study demonstrates favorable lead measurements of lead model 5086MRI in comparison to lead 4592 and 4092 in a short-term follow-up. The number of re-operations was higher in the MRI-PM group, but not statistically different in comparison with the standard dual chamber PM group.

Zusammnefassung

Hintergrund

Wir berichten unsere initiale Erfahrung hinsichtlich Elektrodenverhalten und Reoperationsrate des Medtronic EnRhythm MRI Sure Scan Schrittmachersystems im Vergleich zu den an unserer Abteilung benützten Standardschrittmachersystemen und -elektroden.

Methoden

Alle Patienten mit erfolgreicher Schrittmacherimplantation (außer jenen mit transvenösen linksventrikulären Elektroden) an unserer Abteilung zwischen 01.03.2009 und 31.10.2009 wurden in diese retrospektive Studie eingeschlossen und bis Mitte Januar 2010 nachbeobachtet. Elektrodenmesswerte (erhoben bei Implantation, vor Entlassung [1. Kontrolle] und bei der 4- bis 6-Wochen-Kontrolle [2. Kontrolle]) wurden verglichen zwischen den atrial implantierten Elektroden 4592–53 und 5086MRI–52 (Elektrodengruppe 1) und den ventrikulär implantierten Elektroden 4092–58 und 5086MRI–52/58 (Elektrodengruppe 2). Gründe für Reoperationen wurden ebenfalls erhoben und zwischen den Patienten mit Standard-DDD-Schrittmachern (DDD-SM) sowie den Patienten mit dem EnRhythm MRI SureScan Schrittmachersystem (MRI-SM) verglichen.

Ergebnisse

Im Implantationszeitraum wurde 140 Patienten erfolgreich ein Schrittmachersystem (VVI-SM: 36; DDD-SM: 102; biv. SM: 1) implantiert. Zwei Patienten mit transvenösen linksventrikulären Elektroden wurden von der weiteren Analyse ausgeschlossen. Rechtsatrial wurde das Elektrodenmodell 4592–53 bei 51 Patienten implantiert, das Modell 5086MRI–52 bei 40 Patienten. Elektrodenmodell 4092–58 wurde bei 64 Patienten rechtsventrikulär implantiert, Elektrodenmodell 5086MRI bei 41 Patienten. Die Nachbeobachtungszeit betrug 26 ± 11 Wochen. Beim Vergleich der Elektrodenmesswerte von Elektrodengruppe 1 zeigten sich signifikante Unterschiede für die Stimulationsimpedanz und Reizschwelle bei Implantation sowie für die Wahrnehmungsamplitude bei der 2. Kontrolle. Der Vergleich der Elektrodenmesswerte der Elektrodengruppe 2 zeigte signifikante Unterschiede für die Stimulationsimpedanz bei Implantation, für die Reizschwelle bei der 1. Kontrolle sowie für alle drei Parameter (Wahrnehmungsamplitude, Reizschwelle, Stimulationsimpedanz) bei der 2. Kontrolle. Insgesamt waren alle Elektrodenmesswerte bei jeder Kontrolle für alle Elektroden akzeptabel. Die Anzahl der Reoperationen war in beiden DDD-Schrittmachergruppen hoch, jedoch bestand kein signifikanter Unterschied (DDD-SM: 5 Patienten, 8,5%; MRI-SM: 5 Patienten, 13,2%).

Schlußfolgerung

Unsere Studie zeigt in dem kurzen Beobachtungszeitraum akzeptable Elektrodenmesswerte für die 5086MRI-Elektroden im Vergleich mit den Elektrodenmodellen 4595 und 4092. Die Anzahl der Reoperationen war in der MRI-SM-Gruppe zwar höher, der Unterschied war jedoch statistisch nicht signifikant.

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Conflict of interest

The corresponding author states the following: Dr. C.G. Wollmann: Biotronik, Boston Scientific, St. Jude Medical (consulting); Dr. H. Mayr: Medtronic (consulting).

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Authors and Affiliations

  1. Department of Cardiology, Hospital of St. Pölten-Lilienfeld, Propst Führer-Str. 4, 3100, St. Pölten, Austria

    C.G. Wollmann MD, K. Thudt MD, P. Vock MD, S. Globits MD & H. Mayr MD

  2. Karl Landsteiner Society, Institute of Cardiovascular Research, St. Pölten, Austria

    C.G. Wollmann MD, K. Thudt MD, P. Vock MD, S. Globits MD & H. Mayr MD

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  1. C.G. Wollmann MD
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  2. K. Thudt MD
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  3. P. Vock MD
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Correspondence to C.G. Wollmann MD.

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Wollmann, C., Thudt, K., Vock, P. et al. Clinical routine implantation of a dual chamber pacemaker system designed for safe use with MRI. Herzschr. Elektrophys. 22, 233–242 (2011). https://doi.org/10.1007/s00399-011-0161-y

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