Europace Advance Access originally published online on August 17, 2006
Europace 2006 8(10):863-869; doi:10.1093/europace/eul093
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ICD
Inappropriate implantable cardioverter-defibrillator discharges unrelated to supraventricular tachyarrhythmias
Divisione Clinicizzata di Cardiologia, Facoltà di Medicina e Chirurgia di Novara, Università degli Studi del Piemonte Orientale, Azienda Ospedaliera Maggiore della Carità, Corso Mazzini 18, 28100 Novara, Italy
Manuscript submitted 6 February 2006. Accepted after revision 11 May 2006.
* Corresponding author. Tel: +39 0321 3733413; fax: +39 0321 3733407. E-mail address: occhetta{at}r-j.it
| Abstract |
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Aims The development of implantable cardioverter-defibrillators (ICDs) with QRS morphology discrimination and dual-chamber sensing capabilities has improved the differentiation of supraventricular from ventricular tachycardias (VTs). Inappropriate ICD discharges may result from extracardiac signals caused by electromagnetic interference (EMI), because of electric fields and leakage currents from domestic or medical electrical devices, damaged sensing leads, and various cardiac and extracardiac signals that mimic VT and/or ventricular fibrillation. The aim of our study was to determine retrospectively the incidence and clinical relevance of these ICD behaviours and offer possible therapeutic solutions.
Methods and results We have observed inappropriate discharges unrelated to supraventricular arrhythmias in 13 (3.9%) of the 336 patients implanted with ICDs in our centre from 1989 to 2005. Seven patients received inappropriate shocks following exposure to external EMI: improperly grounded electric stove, electrically powered watering system, hydro-massage bath, electrical pruner, electrocautery current during cardiac surgery, transcutaneous electric nerve stimulation. In four patients, spurious discharges were related to internal noise of the ICD system from inappropriate lead connections. In two cases, erroneous antitachycardia therapy was delivered following different body signals oversensing (T-wave oversensing, wide QRS double-counting and myopotentials). In nine patients, non-invasive solutions prevented further inappropriate therapies (avoidance of EMI, malfunctioning atrial lead exclusion, ventricular sensing reprogramming). In four patients, surgical revision of the system was required (lead connections or position revision).
Conclusion In our experience, inappropriate ICD discharges unrelated to supraventricular arrhythmias occurred in about 4% of ICD patients. A careful evaluation of clinical data and telemetric information (lead impedance, sensed R-wave, stored electrograms) is essential in order to understand the nature of inappropriate ICD discharges and to select the most appropriate solution.
Key Words: Implantable cardioverter-defibrillator, Inappropriate therapies, Electromagnetic interference, Oversensing, Troubleshooting
| Introduction |
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The implantable cardioverter-defibrillator (ICD) has had a dramatic impact on the management of patients with ventricular tachycardia (VT) and ventricular fibrillation (VF), markedly reducing the risk of sudden cardiac death in this high-risk group of patients.1
Although they are generally safe, major complications may occur, one of the most common being inappropriate therapy delivery.6
Supraventricular arrhythmias remain the most common cause of inappropriate discharges, despite the fact that ICDs with rate algorithms (onset and stability), QRS morphology, and dual-chamber pacing/sensing capability have markedly improved the discrimination of supraventricular from ventricular tachycardias.7
9
Inappropriate shocks are still delivered in up to 510% of patients with dual-chamber discrimination algorithms enabled.10
Inappropriate shocks may also result from the detection of spurious signals mimicking VT and VF, such as electromagnetic interference (EMI), sensing-lead malfunction, and oversensing of various physiological (cardiac and extra-cardiac) signals.11
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We report the results of a retrospective analysis of our experience in evaluating the incidence and features of these particular types of inappropriate ICD discharges.
| Population |
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From 1989 to 2005, in accordance with clinical and electrophysiological indications, we have implanted 518 ICDs in 336 patients (289 men and 47 women; mean age 65±11; range 1782 years) with ischaemic heart disease (n=221), dilated cardiomyopathy (n=74), or other arrhythmogenic cardiac diseases (n=41). The type of device implanted changed over time in keeping with the evolution of technology and indications. Altogether, we implanted 328 single-chamber, 144 dual-chamber, and 46 biventricular ICDs.
During follow-up, ranging from 2 months to 14 years (cumulative 12 020 months; 36 months/patient), we have observed in 13 patients (3.9%) inappropriate ICD discharges due to the detection of anomalous signals mimicking VT or VF.
The false detection episodes can be classified as follows:
- extracardiac interference caused by electromagnetic signals from electrical devices in four patients;
- interference caused by a medical management error with ICD not disabled during medical therapeutic approach with electrical devices in three patients;
- interference caused by internal ICD system noises due to a damaged sensing lead or loose lead connections at the headers or adapters in four patients;
- inappropriate detection of various physiological signals (cardiac: double QRS detection and T-wave oversensing; extracardiac: myopotential oversensing) in two patients.
Clinical characteristics, ICD manufacturers, and causes of inappropriate ICD shocks in the study group are listed in Table 1.
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| Inappropriate shock delivery caused by extracardiac interference by electromagnetic far fields from electrical devices |
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Electromagnetic signals emitted by various sources may interfere with proper pacemaker/ICD function. The most common responses to EMI include inhibition or triggering of pacemaker stimuli, reversion to asynchronous pacing and spurious ICD tachyarrhythmia detection.11
In our population, inappropriate ICD discharges following exposure to EMI have been observed in seven patients (2.1%). In all cases, stored electrograms showed high-frequency signals with irregular cycle length, compatible with electrical noise signals.
The following ICDs were used: Defender I 9001 (two patients), Defender II 9201 (one patient), Alto DR 614 (one patient), Lyra 2021 (one patient) (Ela Medical, Le Plessis-Robinson, France); Prizm II VR 1860 (one patient), Contak Renewal H135 (one patient) (Guidant Inc., St Paul, MN, USA).
- Extracardiac interference caused by electromagnetic signals from electrical devices.
- (a) One patient (No. 1) received several ICD shocks while working in the kitchen close to an improperly grounded electric stove. Appropriate grounding of the appliance eliminated further inappropriate discharges.
- (b) In three patients (Nos 4, 6, 12), inappropriate ICD therapy delivery was related to current leakage from malfunctioning electrical devices (electrically powered watering system, hydro-massage bath, electric pruner). In these three cases, once the patients had been taught to avoid close contact with the devices, no further spurious shocks occurred.
- (a) One patient (No. 1) received several ICD shocks while working in the kitchen close to an improperly grounded electric stove. Appropriate grounding of the appliance eliminated further inappropriate discharges.
- Interference caused by a medical management error.
- (a) In one case (No. 8), inappropriate shocks were delivered after the application of electrocoagulation current during cardiac surgery: tachyarrhythmia therapies of the previously implanted device had been inadvertently enabled.
- (b) In two patients (Nos 10, 11), inappropriate shocks were triggered by transcutaneous electrical nerve stimulation (Figure 1); the patients were instructed to avoid this kind of therapy, and no further inappropriate shocks were registered during follow-up.
- (a) In one case (No. 8), inappropriate shocks were delivered after the application of electrocoagulation current during cardiac surgery: tachyarrhythmia therapies of the previously implanted device had been inadvertently enabled.
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In another nine patients, we observed, during the follow-up, short noise detections interrupted at the ventricular arrhythmia reconfirmation and without inappropriate ICD shocks. In two patients, we were able to correlate these noise detections with malfunctioning electrical devices (sewing machine and radio alarm clock). In seven patients, the source of electrical interference remained unknown.
| Inappropriate shock delivery caused by internal ICD system noise |
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Sensing lead fracture or insulation failure, loose lead connections at the ICD header or adapters may result in the oversensing of non-physiological signals and consequent inappropriate ICD therapy delivery.
System problems leading to spurious shocks were observed in four subjects (1.2%).
Two patients were implanted with earlier, more primitive abdominal devices. In both patients, inappropriate shocks were confirmed by stored electrograms, which showed high-frequency noise preceding each ICD discharge.
The first patient (No. 2) had a single-chamber VVI-ICD (Guardian 4210, Telectronics Pacing Systems Inc., Englewood, CO, USA) connected with epicardial defibrillating patches (Telectronics 040-106) and with epicardial pacing-sensing leads (Telectronics 030-575). Manipulation of the abdominal device induced noise signals in the ventricular sensing channel. During surgical examination, one of the epicardial leads was found to be disconnected from the header. The system was repaired by inserting a more secure screw connection, and during follow-up no further malfunction was documented.
The second patient (No. 3) had a VVI-ICD (Guardian 4210, Telectronics) connected to epicardial defibrillating patches (Telectronics 040-106) and with an endocardial pacing-sensing lead (Telectronics 330-258) using an extension adapter. Noise signals could be evoked by manipulating the connection between the endocardial lead termination and the adapter head. The adapter was removed, a new ICD was implanted in the left pectoral site, and a direct connection was established with the endocardial lead and epicardial patches, tunnelled from the abdominal site (Figure 2). No further spurious arrhythmia detection was registered during the following years.
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More recently, inappropriate ICD therapies were observed in another two patients. One of these (No. 7) was implanted with a single-chamber VVI-ICD (Lyra 2020, Ela Medical), connected to a Medtronic 6942 endocardial lead (Medtronic Inc., Minneapolis, MN, USA). Retrieval of stored electrograms showed high-frequency noise preceding the shocks. Suspected conductor fracture of the sensing lead was confirmed during surgical evaluation. After replacement of the lead, the system functioned properly for years.
In the other patient (No. 13), implanted with a dual-chamber ICD (Defender IV 612, Ela Medical), three episodes of sinus tachycardia were interpreted and consequently treated as ventricular arrhythmias because of the lack of atrial sensing from a damaged atrial lead (impedance >2 k
). De-activation of the atrial channel with ICD reprogramming in VVI avoided any further inappropriate therapies.
| Inappropriate shock delivery due to oversensing of body signals |
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The detection of cardiac signals (double QRS sensing, P-wave or T-wave oversensing) and non-cardiac signals inside the body (myopotential oversensing) with fulfillment of rate criteria may induce inappropriate therapy delivery.
In our study population, spurious shocks related to such mechanism were reported in two patients (0.6%).
One patient (No. 9), with a history of myocardial infarction who had received a single-chamber ICD (St Jude Atlas VR V-199, St Jude Medical, St Paul, MN, USA), experienced inappropriate shocks due to both T-wave oversensing and wide QRS double counting; surface ECG showed left bundle branch block. By lengthening the ventricular refractory period, further inappropriate therapies were avoided (Figure 3).
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The second patient (No. 5), with hypertrophic cardiomyopathy implanted with a dual-chamber ICD (Ventak AV 1810, Guidant Inc.), reported two shocks following syncopal spells. From the analysis of the stored electrograms, we were able to see that the episodes were related to myopotential oversensing, probably due to diaphragmatic muscle activation. In this patient, who was pacemaker-dependent as a result of previous radiofrequency atrioventricular node ablation, this oversensing also inhibited ventricular pacing. Reducing ventricular sensitivity did not solve the problem and further inappropriate shocks occurred. An independent screw-in bipolar pacing/sensing lead was, therefore, inserted and fixed in the mid-interventricular septum (Figure 4). During follow-up, no further spurious discharges were observed.
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| Discussion |
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This paper reports our experience of inappropriate ICD discharges unrelated to supraventricular arrhythmias. Several complex algorithms have recently been developed in order to improve discrimination between supraventricular and ventricular arrhythmias. Nevertheless, inappropriate ICD discharges are still a relevant clinical issue. In our centre, it seems to be a non-negligible problem, involving about 4% of our ICD population.
Electromagnetic external signals can interfere with pacemaker and ICD function; both inappropriate ICD discharges and inactivation have been reported.11
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In 1989, Karson et al.14
reported a case of inadvertent ICD de-activation by a magnet located in the loudspeaker of a stereo system. Since then, anecdotal reports have been published involving a magnetic bingo wand15
and remote controls of toys.16
More recently, Seifert et al.17
reported a case of inappropriate ICD shocks caused by EMI from an electric razor: EMI was caused by a defective insulation of the electrode and could not be evoked with an intact electrode. Even slot machines have been reported to induce inappropriate shocks in ICD patients, despite system integrity.18
Most of the previous reports of EMI in ICDs involved earlier, less sophisticated devices with epicardial screw-in sensing leads. Theoretically, endocardial leads should be better protected from EMI because of both the spatial orientation of the endocardial dipole and the endocardial location itself.19
Integrated bipolar lead systems are more likely to be affected by ventricular oversensing than leads with dedicated bipolar sensing electrodes.20
Seifert's study17
suggested that a defect in the insulation of the electrode leading to a unipolar system is a necessary prerequisite for an oversensing effect.
A common medical source of EMI is Transcutaneous Electric Nerve Stimulation (TENS), which is a widely used method of relieving various musculoskeletal pains. Indeed, several well-documented cases of spurious shocks triggered by TENS application in patients with a variety of lead configurations and sensing algorithms have been described.21
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In our population, we observed a considerable EMI effect in six patients, all of whom had intact, bipolar, endocardial leads. In all these patients, the autogain sensing was active and not programmable, as in all other ICD patients; thus, this algorithm seems not to have influence in EMI detections. Simply instructing the patients to avoid specific activities and to ensure the appropriate grounding of the electrical device responsible enabled correct ICD function to be re-established.
Nowadays, cellular telephones might be clinically relevant sources of EMI and might affect ICD function. Previous studies23
,24
have shown that ICDs are resistant to interference from cordless cellular phones. Nevertheless, some ICDs are equipped with particular filters, which may reduce EMI from mobile telephones.
Very recently, Gurevitz et al.25
have shown that patients who receive an ICD can resume work in industrial facilities after appropriate individual testing has been conducted.
In clinical practice, EMI effects may be minimized by recommending general precautions, which include ensuring appropriate grounding of electric appliances and avoiding close contact with EMI sources. Furthermore, ICD de-activation seems mandatory prior to exposure to diagnostic and therapeutic procedures that involve strong sources of EMI when deemed indispensable.
In our study group, three patients suffered inappropriate ICD discharges related to internal malfunction of the system. Malfunction of the rate-sensing lead has been reported with both epicardial and endocardial leads. Although endocardial lead systems seem to be less prone to insulation or conductor fracture, long-term experience with epicardial leads is lacking.26
28
Grimm et al.26
reported a 1% incidence of malfunction of the endocardial rate-sensing lead, in comparison with an incidence of 57% in systems with epicardial leads. In two of our patients, this complication was observed with earlier, less sophisticated devices: completely epicardial in one case and mixed endo-epicardial in the other. Conductor fracture of the sensing lead of a recently implanted endocardial system was responsible for several inappropriate ICD discharges in the third patient. This is not a rare complication; Morishima et al.29
have described a similar case. In the event of suspected lead fracture, it is important to take a chest X-ray.
In 1989, Ballas et al.30
described the use of the beep on R-wave function involving an audio recorder and Holter monitor to identify possible rate-sensing problems. Though this approach was very useful in cases of suspected ICD malfunction, it required ad hoc equipment. Today, the stored electrograms recorded from the system leads have markedly improved the retrospective analysis of episodes of ICD malfunction. An interesting study by Ellenbogen et al.31
has recently demonstrated the importance of ring-to-coil impedance measurement in detecting early lead failure.
The oversensing of physiological intracardiac signals is a well-known cause of inappropriate ICD therapy delivery. Patients with low-amplitude R-waves may require higher sensitivity settings; this may result in T-wave oversensing, with consequent inappropriate inhibition of bradycardia pacing or erroneous detection of ventricular arrhythmias. The mechanism responsible for the double counting of R- and T-waves may also include electrolyte abnormality, drugs, and changes in sympathetic tone.32
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Device reprogramming may suppress the erroneous discharges; in the patient reported in our study who experienced inappropriate shocks related to both T-wave oversensing and QRS double counting, increasing the ventricular refractory period prevented further inappropriate therapies. However, a similar measure imposes potential risk of absent or delayed therapy in case of ventricular arrhythmias; this possibility should always be considered. In other situations, repositioning or adding a separate pacing/sensing lead may be required. In patients with intraventricular delay, biventricular devices with separate inputs for the right and left ventricular leads may prevent double detection of wide QRS complexes, thereby reducing this kind of spurious ICD therapy.
Sensing lead insulation failures in the pocket are a common cause of inappropriate sensing of pectoral or abdominal myopotential signals. In 1998, Deshmukh et al.34
demonstrated that myopotential oversensing may occur in ICD systems with intact integrated bipolar electrodes in the right ventricular apex. More recently, Schulte et al.35
reported inadequate arrhythmia detection due to oversensing of diaphragmatic myopotentials in 8.6% of the 384 patients enrolled; lead failure was ruled out in every case. Reduction in maximum sensitivity was effective in preventing further spurious ICD shocks in the majority of patients with devices with programmable maximal sensitivity. In our patient, this approach was ineffective and the addition of another pacing/sensing lead in the low interventricular septum was necessary in order to solve the problem.
| Conclusion |
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Our findings suggest that inappropriate ICD discharges unrelated to supraventricular arrhythmias constitute a clinical problem involving about 4% of our ICD population.
In the event of suspected ICD malfunction, complete evaluation of the clinical data and telemetric information (including lead impedance and sensed R-wave), in addition to careful analysis of the stored electrograms, is essential in order to identify the problem and to indicate the best management strategies.
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S. Tzeis, G. Andrikopoulos, C. Kolb, and P. E. Vardas Tools and strategies for the reduction of inappropriate implantable cardioverter defibrillator shocks Europace, August 15, 2008; (2008) eun205v1. [Abstract] [Full Text] [PDF] |
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