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Cardiac implantable electronic devices: Patient follow-up

Cardiac implantable electronic devices: Patient follow-up
Literature review current through: Jan 2024.
This topic last updated: Mar 24, 2023.

INTRODUCTION — As more people are living longer with more significant cardiac disease, permanent pacemakers (PPMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices are being implanted more frequently. Beginning early in the 21st century, there has also been an expansion in the indications for cardiac implantable electronic devices (CIEDs, a term which includes PPMs, ICDs, and CRT devices, as well as other devices such as insertable cardiac monitors [also sometimes referred to as implantable cardiac monitors or implantable loop recorders]), and device therapy has become more commonplace.

Issues related to follow-up of patients with a CIED (PPM, ICD, or CRT devices only) will be reviewed here. The indications for PPM, ICD, and CRT use, as well as general issues related these devices, are discussed separately. (See "Permanent cardiac pacing: Overview of devices and indications" and "Secondary prevention of sudden cardiac death in heart failure and cardiomyopathy" and "Primary prevention of sudden cardiac death in patients with cardiomyopathy and heart failure with reduced LVEF" and "Cardiac resynchronization therapy in heart failure: Indications and choice of system" and "Implantable cardioverter-defibrillators: Overview of indications, components, and functions" and "Modes of cardiac pacing: Nomenclature and selection".)

(See "Permanent cardiac pacing: Overview of devices and indications".)

(See "Secondary prevention of sudden cardiac death in heart failure and cardiomyopathy".)

(See "Primary prevention of sudden cardiac death in patients with cardiomyopathy and heart failure with reduced LVEF".)

(See "Cardiac resynchronization therapy in heart failure: Indications and choice of system".)

(See "Modes of cardiac pacing: Nomenclature and selection".)

METHODS AND FREQUENCY OF CIED FOLLOW-UP — For several decades, follow-up evaluation of cardiac implantable electronic devices (CIEDs) required in-person assessment for device interrogation on a recurring basis. Subsequently, transtelephonic monitoring (TTM) became available for some types of permanent pacemakers (PPMs). Current technology, however, has evolved to enable comprehensive and safe remote monitoring for nearly all types of CIEDs [1-3]. Remote monitoring provides alerts in real-time (or on a daily basis), but is not as comprehensive as a complete device interrogation. A major difference between remote monitoring and an in-person interrogation is that a CIED cannot be adjusted or reprogrammed remotely. The equipment required for remote monitoring, which is proprietary and unique to each manufacturer just as the in-person programmers are, along with requirements (eg, internet connection) and instructions for use, should be discussed with the patient as part of the implantation process.

Office-based versus remote follow-up — For most patients, the majority of CIED follow-up device interrogations can be done either in person or remotely (table 1) [3-5]. Following the immediate post-implant check, an initial in-person evaluation (IPE) should occur within weeks to three months post-implantation, and ideally one IPE annually for the duration of therapy with a CIED [6]. With the exception of these initial and annual IPEs, all other CIED follow-up assessments may be done either in person or remotely (if available) (table 2), an approach consistent with the 2015 Heart Rhythm Society expert consensus statement on the remote device interrogation and monitoring [6].

Remote monitoring is strongly encouraged for patients. Multiple prospective randomized trials have demonstrated the feasibility and safety of remote CIED monitoring as well as identified a greater number of clinically significant issues and shortened the time to clinical action [7-15]. Multiple nonrandomized observational studies have suggested improved survival for patients with remote CIED monitoring; however, this has not been universally replicated in prospective randomized trials [16-18]. In a 2015 systematic review and meta-analysis of nine randomized trials involving 6469 ICD recipients who were randomized to either remote monitoring (3496 patients) or in-office follow-up (2973 patients), patients assigned to remote monitoring had nonsignificant reductions in total mortality (odds ratio [OR] 0.83; 95% CI 0.58-1.17), cardiovascular mortality (OR 0.66; 95% CI 0.41-1.09), and hospitalizations (OR 0.83; 95% CI 0.63-1.10) along with significantly fewer inappropriate shocks (OR 0.55; 95% CI 0.38-0.80) [19]. Further evidence of improvements in mortality was seen in a 2017 analysis using patient-level data from only three of the nine randomized trials included in the 2015 meta-analysis (IN-TIME, ECOST, and TRUST) [7,11,13], in which the absolute risk of overall mortality was reduced by 1.9 percent (95% CI 0.1-3.8 percent) [20].

In the 2019 RM-ALONE trial, which included 445 patients with CIEDs (151 ICDs and 294 PPMs including 54 percent pacemaker-dependent patients), participants were randomized to in-office device interrogation or remote device interrogation every six months; all patients in both groups were remotely monitored with daily transmission of alerts with unscheduled office visits at the provider's discretion following an alert [21]. Over a mean follow-up of 21 months, there was no significant difference between the two groups in major adverse cardiac events (20 percent in each group). More patients in the remote interrogation group had an unscheduled office visit (55 percent versus 45 percent of office interrogation patients); however, the remote interrogation group had 79 percent fewer total office visits (136 versus 653 in the office interrogation group). Overall, a strategy of remote-only device monitoring and interrogation appears to be as safe and efficacious as a strategy that includes twice yearly in-office visits. Important limitations include the relatively small sample size and the absence of CRT devices. Additional data from a multi-center randomized trial of remote-only versus periodic IPE, published after the RM-ALONE trial, suggest that remote-only follow-up for up to two years is safe and associated with significantly fewer office visits [22].

While most patients find remote follow-up more convenient, some may find in-office follow-up preferable for a variety of reasons (eg, the desire to be seen in-person more frequently for reassurance, social interaction, etc). With this in mind, the approach to CIED follow-up must be tailored to each individual patient. At present, standard practice continues to include at least an annual office visit, which is felt to be adequate for most patients. (See 'Frequency of CIED follow-up visits' below.)

In some instances, an IPE may be associated with significant risks to patients and healthcare providers. For example, during the COVID-19 pandemic, when the risk of viral transmission was very high, it was recommended by experts to substitute IPEs with remote checks. In April of 2020, the Heart Rhythm Society COVID-19 Task Force recommended that every effort be made to perform CIED interrogation via remote monitoring rather than via IPE [23]. The recommendations stated that IPEs for CIEDs should be limited to potentially hazardous lead or generator issues not adequately assessed by remote monitoring, absolute need for reprogramming, or other issues per physician judgment. A creative response to the COVID-19 pandemic was the creation of drive-through pacing clinics [24].

Frequency of CIED follow-up visits — The frequency of follow-up visits for patients with a CIED will vary according to the type of device, age of the device, and clinical status of the patient (table 2) [4,5]. In general, however, most patients with a CIED should have an annual IPE, with one or more additional follow-up assessments (either remotely or in-person) throughout the year. Patients who have received therapies (eg, ICD shocks or antitachycardia pacing), as well as those whose devices are approaching the end of battery life, may require more frequent follow-up. Furthermore, patients with advisory generators and/or leads may require more frequent follow-up, or additional testing (eg, lead fluoroscopy) during follow-up.

Patients who have an ICD which was placed for primary prevention may require less frequent follow-up. In the REFORM trial of 155 patients receiving a primary prevention ICD based on MADIT II criteria, patients were randomized (following a routine 3-month post-implant visit in all patients) to either 3-month or 12-month follow-up intervals and followed for 24 months [25]. Patients in the 12-month interval group had significantly fewer in-office follow-up visits (1.6 versus 3.9 visits per year), with no significant differences in mortality or hospitalization. While these findings are encouraging regarding the potential for reduced frequency of follow-up in stable recipients of primary prevention ICDs, our recommendations for follow-up will remain unchanged until these data are replicated in other larger patient populations and/or until professional societies alter follow-up guidelines. (See 'Summary and recommendations' below.)

FOLLOW-UP OF THE PATIENT WITH A PACEMAKER — All patients with a permanent pacemaker (PPM) require routine follow-up on a periodic basis. Both office-based and remote follow-up strategies are available, safe, and effective for monitoring of PPM function (table 1). For most stable patients with a PPM, follow-up should occur every three to four months (table 2). However, the frequency of these follow-up visits may increase in certain clinical situations (eg, device nearing battery depletion or a suspected device infection).

PPM evaluation — Whether the system involves a single-chamber or dual-chamber pacemaker, the evaluation is similar. Device interrogation includes the evaluation of several aspects of device function (see "Pacing system malfunction: Evaluation and management"):

Assessment of the presenting and underlying rhythms

Programmed pacing parameters

Pacing and sensing thresholds and lead impedance

Evaluation of pacing capture

Review of recorded episodes of arrhythmia detection, if the device is capable of storing these data

Review of battery status and estimation of time until the pulse generator must be replaced

Review of all additional data collected

Establish programmed parameters — Interrogate the pacemaker so that the programmed parameters as well as measured data of lead and battery function are obtained.

Evaluate capture — To evaluate capture, the paced electrocardiogram (ECG) should be carefully examined. Contemporary pacemakers have automatic pacing threshold testing algorithms. The following points may be helpful when there is difficulty interpreting the auto-threshold tracings or when capture thresholds are determined manually.

If the native rate is faster than the paced rate, thereby inhibiting the system, the rate and/or atrioventricular (AV) interval should be reprogrammed so that stimuli are visible.

Capture is intact if there is a distinct change in the morphology of the QRS or P wave that follows each stimulus and if this morphology is stable and different from the native complexes. If this is not seen, there is noncapture, and the differential diagnosis for failure to capture should be considered. (See "Pacing system malfunction: Evaluation and management", section on 'Causes of loss of capture'.)

If initial evaluation shows a pacing stimulus that is simultaneous with the native QRS complex, changing the rate and AV intervals will be helpful to distinguish capture from fusion.

It may be necessary to assess the capture threshold by adjusting the output and demonstrating loss of capture before it is certain that capture was intact on the initial tracings. If there is loss of capture, one should also consider whether this is true failure to capture or functional loss of capture (ie, failure to sense a native QRS complex followed by the release of the pacing stimulus at a time when the myocardium is physiologically refractory and incapable of being stimulated).

Evaluate sensing — To evaluate sensing, intrinsic complexes must be present. Most contemporary pacemakers have automatic sensing threshold testing algorithms. Similar to capture determination, the following points may be helpful when there is difficulty interpreting the automatic sensing determination or when sensing thresholds are determined manually.

If the rhythm is totally paced, the paced rate can be decreased, the AV delay increased, or the unit programmed to a non-tracking mode in order to evaluate ventricular sensing.

If the system is then inhibited and the native rhythm appears, sensing is intact.

To evaluate atrial sensing, it may be necessary to reduce the base pacing rate and shorten the AV interval. This will result in P wave tracking in the presence of in-tact atrial sensing. If sensing is not present or consistent, the etiology should be evaluated and appropriate corrective actions taken.

Event markers — Event markers are indicators of pacing and sensing reported directly by the pacemaker. However, the fact that the pacemaker released an output pulse does not mean that the pacing stimulus effectively captured the heart muscle and resulted in a depolarization. In addition, the fact that the system reports that it sensed an event does not mean that this was an appropriate complex to be sensed. Thus, the event markers need to be correlated with the surface ECG recordings and/or intracardiac electrogram, and are most valuable when the event markers are printed along with a simultaneously recorded surface ECG or intracardiac electrogram.

A sense marker coinciding with a native P or R wave confirms proper sensing, unless there is a P marker over a native R wave or vice versa, in which case there may be a problem such as a dislodged atrial lead, inappropriate connection of the atrial and ventricular leads into the pulse generator, or far-field sensing. If the event markers indicated that the pacemaker is sensing an event that is not visible on the surface ECG, further evaluation is required.

Electrogram assessment — Endocardial electrograms can be particularly helpful in examining the morphology of the native complexes to determine capture as well as why a given signal may not have been sensed. It is also useful in examining the signals that are being sensed when these are not readily identified from the surface ECG. Electrogram telemetry will greatly facilitate the evaluation, allowing it to be completed more expeditiously and provide information that may not be easily acquired.

FOLLOW-UP OF THE PATIENT WITH AN ICD — All patients with an implantable cardioverter-defibrillator (ICD) require routine follow-up on a periodic basis as well as semi-urgent or urgent follow-up after receiving a shock from the ICD (table 2). Both office-based and remote follow-up strategies are available, safe, and effective for monitoring of ICD function (table 1) [6].

For most stable patients with an ICD who have not received a shock, follow-up should occur every three months. For most visits, follow-up may be in person or remote (if available) according to local protocol, but at least one follow-up per year should be an IPE. However, the frequency of these follow-up visits may increase in certain clinical situations (eg, device nearing end of battery life or a CIED or lead that has been placed on a medical advisory). (See 'Routine ICD follow-up' below.)

Patients with an ICD who have received a single ICD shock and who otherwise feel well should have follow-up within 24 to 48 hours. This follow-up may be done in person or remotely (if available). Patients who receive multiple ICD shocks within a short period of time (minutes to hours), or the patient who receives a single shock and feels unwell, require more urgent evaluation. (See 'Follow-up after ICD discharge' below.)

Routine ICD follow-up — Device interrogation and a detailed review of device function should be performed with each visit [26]. Monitoring for evidence of device complications should also be performed. (See "Cardiac implantable electronic devices: Long-term complications", section on 'Pulse generator complications' and "Cardiac implantable electronic devices: Long-term complications".)

Device interrogation includes the evaluation of several aspects of device function:

Programmed detection criteria and programmed therapy for ventricular tachycardia and fibrillation (VT and VF).

Pacing and sensing thresholds.

Pacing and shocking lead impedance.

Signal amplitudes and morphologies.

Review of recorded episodes of arrhythmia detection and device activation, including pacing and shocks. Current devices include the date and time of each episode and store the electrograms from the event.

In systems containing an atrial lead, review of diagnostic information regarding atrial arrhythmias.

Review of battery status and estimation of time until the pulse generator must be replaced.

Review of all additional data collected

DFT testing as part of routine ICD follow-up — In the past, many centers did defibrillation threshold (DFT) testing at the time of initial implant and at some periodic basis during follow-up. However, the induction and termination of a ventricular tachyarrhythmia has potential complications, is unpleasant for the patient, and adds additional cost, with a benefit to the patient that has not been proven. Although DFT testing at the time of the initial implant remains somewhat controversial, we do not recommend performing DFT testing as part of routine follow-up.

The need for routine DFT testing has been assessed in large randomized clinical trials [27,28]. Both the SAFE-ICD and SIMPLE trials demonstrated that DFT testing does not improve shock efficacy or reduce arrhythmic death.

Follow-up after ICD discharge — Patients who receive one or more shocks from their ICD require review of the episode and either remote or in-clinic follow-up depending on the clinical situation and the institutional guidelines.

The timing and urgency of the follow-up varies according to the clinical scenario:

Patients who receive a single ICD shock without loss of consciousness should have office-based or remote follow-up within 24 to 48 hours. If remote review of the data reveals a single appropriate ICD shock and the patient is feeling well, an IPE may not be required. However, if neither office-based nor remote follow-up is available for longer than 24 to 48 hours, the patient may need to be seen in the emergency department.

For patients who receive a single ICD shock with loss of consciousness or near syncope, the decision as to whether the patient needs to be seen in clinic or in the emergency department will vary according to the clinical situation and the guidelines followed by a specific follow-up center. If a patient has a single appropriate shock as determined by review of remote data, or if the patient is feeling well and was not injured with loss of consciousness, some centers may not recommend a face-to-face visit. If the clinical situation is uncertain and/or if the patient is concerned or has been injured during the loss of consciousness, then the patient should be seen in the clinic or emergency department.

Patients who receive multiple ICD shocks within a short period of time (minutes to hours) should have more urgent evaluation in the emergency department. Patients who are seen in the emergency department should all have a brief history and physical examination, 12-lead electrocardiogram (ECG), and additional laboratory testing as the clinical presentation dictates:

Troponin level in a patient with suspected acute myocardial ischemia

Potassium and magnesium in a patient with suspected electrolyte depletion

Toxin screen in a patient with suspected intentional or inadvertent drug overdose

Because ICDs are placed in patients felt to be at an increased risk of ventricular arrhythmias or sudden cardiac death, ICD discharge is an anticipated event during the long-term follow-up of such patients. Because a single ICD shock frequently represents the appropriate termination of a sustained ventricular tachyarrhythmia, patients who receive only a single ICD shock without loss of consciousness may have follow-up (either office-based or remotely) within 24 to 48 hours to ascertain that the device is functioning properly, to exclude other causes of the ICD shock (eg, supraventricular tachyarrhythmias, device malfunction) and to provide patient reassurance.

Even though a single ICD shock often represents the appropriate termination of a sustained ventricular tachyarrhythmia, ICD discharges that are accompanied by loss of consciousness or near syncope should be promptly reviewed. These patients may need to have programming changes or, in the event of injury related to syncope, more immediate follow-up, usually in the clinic or the emergency department.

Patients who receive multiple ICD shocks or clusters of shocks within minutes to hours require immediate evaluation in the emergency department to determine the cause. Such recurrent discharges may be either appropriate (due to recurrent VT and electrical storm) or inappropriate (due to a supraventricular tachycardia with a rapid rate, or to device malfunction).

If frequent discharges are due to recurrent VT and electrical storm, additional therapy (such as an antiarrhythmic drug or catheter ablation) may be required. These therapies are discussed in detail elsewhere. (See "Secondary prevention of sudden cardiac death in heart failure and cardiomyopathy", section on 'Other treatment options' and "Electrical storm and incessant ventricular tachycardia".)

Prognosis following ICD shocks — Several clinical trials have shown that patients who receive appropriate ICD therapy have a higher mortality than patients who do not. In the SCD-HeFT trial, both appropriate and inappropriate ICD therapy were associated with a higher mortality during follow-up [29]. The delivery of therapy by an ICD, therefore, should prompt clinicians to re-evaluate the patient's overall clinical status and therapeutic plan. (See "Secondary prevention of sudden cardiac death in heart failure and cardiomyopathy".)

Driving following ICD shocks — Guidelines for driving following ICD shocks have been developed by professional societies [30,31]. Legal restrictions on driving in such patients vary widely between municipalities, and each clinician and patient should be aware of his/her own local guidelines.

A more extensive discussion of driving restrictions in patients with an ICD is presented separately. (See "Driving restrictions in patients with an implantable cardioverter-defibrillator".)

FOLLOW-UP OF THE PATIENT WITH A CRT DEVICE — Cardiac resynchronization therapy (CRT) is a device-based therapy which involves simultaneous pacing of both ventricles (biventricular or BiV pacing) or left ventricular pacing in an effort to optimize cardiac synchrony and function. CRT may involve pacing only (CRT-P) or may be combined with the typically therapeutic functions of an ICD (CRT-D).

All patients with a CRT device (either CRT-P or CRT-D) require routine follow-up on a periodic basis, and patients with a CRT-D device require semi-urgent or urgent follow-up after receiving one or more shocks from the ICD (table 2). Both office-based and remote follow-up strategies are available, safe, and effective for monitoring of CRT function (table 1). In general, the protocol for follow-up evaluation for CRT-P or CRT-D devices is similar to that for standard PPMs or ICDs.

For most stable patients with a CRT-P (or CRT-D device with no ICD shocks), follow-up should occur every three to four months. For most visits, follow-up may be in person or remote (if available) according to local protocol, but at least one follow-up per year should be an IPE. However, the frequency of these follow-up visits may increase in certain clinical situations (eg, device nearing battery depletion or a suspected device infection). (See 'PPM evaluation' above and 'Routine ICD follow-up' above.)

Patients with a CRT-D device who have received a single ICD shock should have follow-up within 24 to 48 hours. This follow-up may be done in person or remotely (if available). Patients who receive multiple ICD shocks within a short period of time (minutes to hours) require more urgent evaluation. (See 'Follow-up after ICD discharge' above.)

The optimal approach to programming CRT devices is discussed in greater detail separately. (See "Cardiac resynchronization therapy in heart failure: Indications and choice of system".)

Concerns have been raised regarding the potential for cyber interference with CIEDs. Generally, this has not been shown to be a clinical concern. However, manufacturers are exploring ways to better protect devices from any hacking potential [32-34].

SOCIETY GUIDELINE LINKS — Links to society and government-sponsored guidelines from selected countries and regions around the world are provided separately. (See "Society guideline links: Cardiac implantable electronic devices".)

INFORMATION FOR PATIENTS — UpToDate offers two types of patient education materials, "The Basics" and "Beyond the Basics." The Basics patient education pieces are written in plain language, at the 5th to 6th grade reading level, and they answer the four or five key questions a patient might have about a given condition. These articles are best for patients who want a general overview and who prefer short, easy-to-read materials. Beyond the Basics patient education pieces are longer, more sophisticated, and more detailed. These articles are written at the 10th to 12th grade reading level and are best for patients who want in-depth information and are comfortable with some medical jargon.

Here are the patient education articles that are relevant to this topic. We encourage you to print or e-mail these topics to your patients. (You can also locate patient education articles on a variety of subjects by searching on "patient info" and the keyword(s) of interest.)

Basics topics (see "Patient education: Sudden cardiac arrest (The Basics)")

Beyond the Basics topic (see "Patient education: Implantable cardioverter-defibrillators (Beyond the Basics)")

SUMMARY AND RECOMMENDATIONS — The frequency of follow-up visits for patients with a cardiac implantable electronic device (CIED) will vary according to the type of device, age of the device, and clinical status of the patient (table 2).

Follow-up after pacemaker – For most stable patients with a permanent pacemaker (PPM), follow-up should occur every three to four months. (See 'Follow-up of the patient with a pacemaker' above.)

Follow-up after implantable cardioverter-defibrillator (ICD) – For most stable patients with an ICD who have not received a shock, follow-up should occur every three months. (See 'Follow-up of the patient with an ICD' above.)

Frequency of visits – For stable patients with either a PPM or ICD, follow-up may be in person or remote (if available) according to local protocol, but at least one follow-up per year should be an in-person evaluation (IPE) (table 1). The frequency of these follow-up visits may increase in certain clinical situations (eg, device nearing end of battery life or a suspected device infection). (See 'Follow-up of the patient with a pacemaker' above and 'Routine ICD follow-up' above.)

Follow-up post-ICD shock

Single shock – Patients who receive a single ICD shock without loss of consciousness, and who otherwise feel well, should have office-based or remote follow-up within 24 to 48 hours.

-If remote review of the data reveals a single appropriate ICD shock and the patient is feeling well, an IPE may not be required. However, if neither office-based nor remote follow-up is available for longer than 24 to 48 hours, the patient may need to be seen in the emergency department.

-If the clinical situation is uncertain and/or if the patient is concerned or has been injured during the loss of consciousness, then the patient should be seen in the clinic or emergency department.

Multiple shocks – Patients who receive multiple ICD shocks within a short period of time (minutes to hours), or the patient who receives a single shock and feels unwell, should have more urgent evaluation in the emergency department. Patients who are seen in the emergency department should all have a brief history and physical examination, 12-lead electrocardiogram, and additional laboratory testing as the clinical presentation dictates. (See "Cardiac implantable electronic devices: Long-term complications".)

ACKNOWLEDGMENT — The UpToDate editorial staff thank David L. Hayes, MD, and Leonard Ganz, MD, FHRS, FACC, who contributed to an earlier version of this topic review.

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Topic 1015 Version 42.0

References

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