© 2003 by European Society of Cardiology
CASE REPORT
Potential device interaction of a dual chamber implantable cardioverter defibrillator in a patient with continuous spinal cord stimulation
1Department of Medicine-Cardiology, University of Bonn Bonn, Germany; 2Department of Cardiac Surgery, University of Bonn Bonn, Germany
Manuscript submitted 13 February 2003. Accepted after revision 22 June 2003.
Correspondence: Rainer Schimpf, Ist Department of Medicine, University Hospital Mannheim, Theodor-Kutzer-Ufer 1-3, D-68167 Mannheim, Germany. Tel.: +49-621-3832206; Fax: +49-621-3833061.E-mail: rainer.schimpf{at}med.ma.uni-heidelberg.de
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Abstract |
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Spinal cord or thalamic deep brain stimulation with a pacemaker is becoming more important in the treatment of drug refractory pain due to peripheral vascular disease, angina pectoris and intractable tremor in patients with neurologic disorders such as Parkinson's disease. An additional indication for a cardiac pacemaker or implantable cardioverter defibrillator raises concerns about possible interactions between the implanted electrical devices. We report on a patient with existing spinal cord stimulation who survived sudden cardiac death and received a dual chamber cardioverter defibrillator capable of delivering tiered therapies in both the atrium and ventricle.
Key Words: Spinal cord stimulation, neurostimulation, cardiac pacemaker, implantable cardioverter defibrillator, interference
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Introduction |
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Application of electrical impulses to the spinal cord with a stimulator nowadays extends the options in the treatment of severe pain in patients with peripheral vascular disease and angina pectoris[1–
4]. The spinal electrode, implanted at the thoracic or cervical level, effectively reduces the pain in hitherto untreatable patients by permanent or intermittent stimuli. In neurologic disorders with intractable tremor such as Parkinson's disease, thalamic deep brain stimulation can increase quality of life with restoration of mobility[5]. However, an additional indication for a cardiac pacemaker or implantable cardioverter defibrillator (ICD) raises concerns about possible interactions of the electrical devices and the problem as to whether the neurostimulator has to be deactivated or even explanted in favour of safe and correct ICD function. Interferences between devices could result in detection of the high frequency impulses of the neurostimulator followed by inappropriate high volt shock delivery of the ICD which conversely may lead to malfunction of the spinal cord stimulator (SCS). Additionally, atrial treatment options of new generation ICDs could be influenced. |
Case report |
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A 70-year-old man suffered from severe general arterial sclerosis. Peripheral vascular disease without surgical and pharmacological treatment options and significant pain led to the implantation of a device for spinal cord stimulation in 1998 (ITREL 3, 7425, Medtronic Inc., Minneapolis, MN, U.S.A.). The device was implanted in the lower left abdomen. The quadripolar electrode (Pisces, 3888, Medtronic Inc.) with an interelectrode spacing of 6 mm was placed in the epidural space on the dorsal aspect of the spinal cord at the level of the 11th thoracic vertebra (Fig. 1>). With continuous unipolar stimulation the patient reported significant reduction of his pain during follow-up. Additionally, the patient had severe coronary artery disease with inferior myocardial infarction in 1985 and congestive heart failure. Furthermore, he suffered from paroxysmal atypical atrial flutter/fibrillation and intermittent sinus bradycardia. In January 2001 he was successfully resuscitated from ventricular fibrillation. In a peripheral hospital a myocardial infarction was excluded. The invasive procedures revealed severe three vessel coronary disease and non-sustained ventricular tachycardias in the electrophysiological study. The patient was then transferred to our institution for coronary bypass surgery and implantation of an ICD. Three weeks after revascularization therapy a dual chamber cardioverter defibrillator with the additive option of tiered atrial therapies (GEM III AT, 7276, Medtronic Inc., Minneapolis, MN, U.S.A.) was implanted. The implanted atrial electrode provides bipolar sensing and stimulation (CapSureFix Novus, 5076, Medtronic Inc., tip to ring distance 10 mm), whereas the tripolar ventricular electrode covers ventricular sensing/pacing and defibrillation (SPRINT, 6943 Medtronic Inc.) with true bipolar sensing via closely separated electrodes (9 mm). In contrast to cardiac pacemakers safe and adequate sensing of high rate (
120 ms cycle length) and very low amplitude signals (
0.3 mV) during ventricular fibrillation have to be guaranteed by the device to provide safe detection and correct therapy delivery for malignant tachyarrhythmias. On the other hand, inadequate therapies due to myopotential sensing should be reduced without sacrificing correct detection of ventricular fibrillation signals. Furthermore, clear differentiation between atrial potentials is required to allow adequate complex algorithm performance for differentiation between ventricular and supraventricular tachycardias and for initiation of atrial therapies.
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The spinal cord stimulator (SCS) was programmed in the best mode for pain reduction, individually tested in the period after initial implantation. The pulse generator delivered a continuous burst of stimuli at a rate of 85 pulses per second. The optimal mode for pain relief, with minimal discomfort due to the stimuli in this patient, was unipolar stimulation from the device housing to the distal electrode with an output of 2.5 V at an impulse duration of 200 µs.
Intraoperatively, postoperatively at the pre-hospital discharge test and during follow-up both devices have been thoroughly checked including different breathing manoeuvres at various body positions. First the standard programming of the SCS was analysed. During standard spinal stimulation even at the highest sensitivity of the ICD sensing circuits (0.3 mV, ventricular electrode and 0.15 mV, atrial electrode) no artefacts or oversensing could be detected. Then, the output, still kept in unipolar configuration was elevated until 6 V with an impulse duration of 450 µs was reached. Furthermore, various impulse durations and rates were applied ranging from 200 to 450 µs and from 20 to 130 Hz, respectively. At maximal output, which would never be clinically applied because of significant discomfort for the patient, intermittent signals in the atrial and ventricular channel of the ICD have been documented. The amplitudes were 0.05–0.2 mV and have not been annotated by the ICD as sensed events despite maximal sensitivity (Fig 2 and Fig 3). The procedure was repeated with bipolar stimulation of the SCS with no adverse effects. Afterwards, ventricular fibrillation was induced and terminated thrice with 20 J to verify a 10 J safety margin in case of an increase in the defibrillation threshold. No undersensing of the myocardial potentials or oversensing of impulses of the continuously active neurostimulator with maximal output in the unipolar mode was documented. The neurostimulation device revealed no adverse effects after each of the shock deliveries, which was confirmed by interrogation of the system with unchanged impedance of the stimulation lead (550±10 
), documentation of no reset of the system and a clinically stable threshold for stimulation perception. At the pre-discharge test the procedure was repeated with no adverse events. During follow-up of 6 months the patient had several recurrent atrial flutter/fibrillation episodes with adequate detection and termination by atrial burst pacing (Fig 4) and no ventricular arrhythmia. Furthermore, neurostimulator function was clinically not altered as it generated continuous symptomatic benefit in the treatment of the peripheral vascular disease.
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Discussion |
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The introduction of SCS has extended the treatment of severe pain in patients with peripheral vascular disease and angina pectoris. Stimulating the spine at the thoracic or cervical level of the dorsal column has been reported to reduce pain effectively in hitherto untreatable patients[1
–4]. In neurological disorders with intractable tremor, such as Parkinson's disease, thalamic deep brain stimulation can increase quality of life with restoration of a normal mobility[5]. Pacing the vagal nerve is becoming an additive treatment option in patients with drug resistant epilepsy[6]. Furthermore, positive effects in first clinical studies of vagal nerve stimulation on psychiatric disorders may lead to an indication in patients with e.g. drug resistant severe depression[7]. Thus, with a growing indication for SCS the coincidence with an indication for an ICD will potentially increase. Consecutively, simultaneous implanted pacing systems raise concerns about possible device–device interactions.
In the literature there have been reports on simultaneous implantation of cardiac pacemakers and SCSs, which can safely be performed if certain precautions are carefully followed[8–11]. Reports about coincidence with an ICD are rare. Monahan et al.[12] presented the first case of a single chamber true bipolar sensing and pectoral implanted ICD. The patient with intractable pain secondary to failed back surgery had a previous SCS implanted at the level of the 11th thoracic vertebra. Testing various stimulation settings did not reveal any oversensing of impulses by the ICD or device failure of the SCS after ICD-shock therapy. During follow-up of the patient no adverse events were reported. Deep thalamic brain stimulation with severe Parkinson's disease effectively diminished symptoms in two patients before they received an ICD after resuscitation[13,14]. The bipolar lead of the SCS in the first case was implanted in the right ventral intermediate nucleus of the thalamus and the device ipsilateral in the subclavicular area, whereas the dual chamber ICD was located in the right subclavicular area[13]. During testing with bipolar and unipolar stimulation and different impulse rate, voltage and width settings no oversensing was evident. Induction of ventricular fibrillation was successfully detected and terminated. Tavernier et al. described in the preceding report no interactions between two ipsilateral implanted leads of neurostimulators in the right and left subthalamic nucleus and a single chamber ICD[14]. In none of the patients, including ours, did bipolar or unipolar stimulation result in significant interference with ICD function. However, experience in patients with spinal cord stimulation for intractable pain due to angina pectoris are lacking. Since the location of the spinal cord electrode in these patients is usually at the first and second cervical level the electrical fields of the SCS and ICD should have probable interference. Due to the close electrical fields in this scenario potential interactions have to be carefully assessed and tested to decide whether both systems could be permanently activated or if the SCS has to be deactivated or removed in favour of correct ICD function.
Furthermore, neurostimulator function has to be assessed. Up to now damage of the system after shock deliveries has not been reported. In case of insulation damage to the neurostimulator lead and consequent short circuit at shock delivery, neurological tissue damage cannot be excluded and explantation of the device has to be considered.
Finally, although not reported, possible complications such as electrode fracture, insulation failure or dislocation of SCS leads with an altered electrical vector could generate leakage current which could be detected and inadequately treated by the ICD. Hence, it seems reasonable to maintain short follow-up intervals of both systems to enhance early detection of device or electrode malfunction which should include: regular radiological controls of stable lead positions, lead impedance, sensing measurement for both devices, stimulation threshold for the ICD, clinical stimulation tests of the SCS including higher output stimulation in bipolar and unipolar mode and breathing manoeuvres in upright and supine position with continuous telemetry of the ICD-lead.
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Clinical implications |
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With an extended clinical spectrum for neurostimulation therapy coincidence with an indication for an ICD is becoming increasingly likely. This case report provides further evidence that a transvenous, true bipolar sensing dual chamber ICD system can be used in patients with a pre-existing SCS for peripheral vascular disease. However, extensive intraoperative and close postoperative testing of the integrity of each system and search for device interference is crucial and has to be continuously reevaluated. In case of interference deactivation and even explantation of the neurostimulator has to be considered.
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References |
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[1] Di Pastena A, Fioranelli M, Celleno D, Delli Muti M. SCS in intractable angina. Minerva Anestesiol 2000; 66: 825–827.[Medline]
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