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............................................................................................................... preferable to prevent the risk of subclavian crush of the lead associated with arm exercises above shoulder level. It is recommended to abstain from vigorous exercise and ipsilateral arm exercise for 46 weeks post-device implantation.

Of note, recommendations regarding sports activity in patients with an ICD differ from those in pacemaker patients.797,798

11.6 When pacing is no longer indicated

Different management options are available in patients with implanted pacemaker systems in whom pacing is no longer indicated:

Leave pacemaker generator and pacemaker leads in situ. Explant pacemaker generator and abandon leads. Explant pacemaker generator and leads. The feasibility of option 1 depends on the end-of-life behaviour of the implanted generator, which is manufacturer dependent, and may be erratic and lead to complications in rare cases.799 Option 1 is the preferred approach to selected frail and elderly patients. Option 2 comes with a low procedural risk but may be associated with the disadvantages of lead abandonment, including future MRI. Especially in young patients, the potential necessary future requirement for lead extraction of abandoned leads due to infection and the associated elevated procedural risk due to longer duration of implantation procedure need to be taken into account. Several studies have shown increased complexity, lower procedural success, and higher complication rates of lead extraction procedures of abandoned leads.800803 Option 3 comes with the highest initial procedural risk, but eliminates all possibilities of future device-related complications. When performed in specialized high-volume centres with current extraction tools, lead extraction procedures can be carried out with high complete procedural success rates and low complication rates.802 This approach may be appropriate for the combination of a young patient, low risk for extraction, and an experienced extractor. As part of a patient-centred approach, the decision in such situations has to be based on an individual riskbenefit analysis in a shared decision-making process together with the patient and his/her carers. This includes providing sufficient information to achieve an informed decision-making. Important factors to take into consideration are patient age, patient condition, comorbidities, pacemaker system, lead implant duration, and the patient’s life expectancy.

11.7 Device follow-up

General principles of follow-up are covered here, as in-depth recommendations are beyond the scope of this document. The patient and the device should be treated as a single entity, with programming tailored to meet the patient’s needs. The goals are to (i) ensure patient safety; (ii) provide physiological pacing; (iii) improve patient quality of life; (iv) improve patient clinical management; and (v) maximize device longevity. Requirement for follow-up of the underlying cardiac disease should not be overlooked. In addition to the technical check and optimization of programming, proper counselling of the patient and his/her family are necessary to meet these goals. The frequency of follow-up depends on the type of device (CRT and HBP are associated with more clinical or technical issues and need closer surveillance) and whether they are on remote device management (Table 13).

• Remote device management includes remote follow-up with full remote device interrogation at scheduled intervals (to replace in-office visits), remote monitoring with unscheduled transmission of pre-defined alert events, and patient-initiated follow-up with unscheduled interrogations as a result of a patient experiencing a real or perceived clinical event. Most studies have focused on patients with ICDs and CRT-Ds, and have shown a significant reduction in delay between event detection/clinical decision, and fewer inappropriate shocks.804 Two randomized non-inferiority trials with single-chamber805 or DDD805,806 pacemakers (no CRT-P) showed that in-office visits can be safely spaced to 1824 month intervals if patients are on remote monitoring with devices having automatic threshold algorithms. Spacing of scheduled in-office visits is particularly convenient for elderly patients with limited mobility, but also for young or midlle-aged patients with full-time jobs, family commitments, etc., and in specific situations (e.g. to avoid exposure during a pandemic). • It is important to conduct remote device management with an appropriate set-up that delivers a structured approach to remote follow-up and a timely response to alerts. Third-party providers can be useful to triage alerts and assist with this task.807 Importantly, compliance with the General Data Protection Regulation should be respected, as outlined in a recent ESC regulatory affairs/EHRA document.808

Recommendation when pacing is no longer indicated

Recommendation Classa Levelb

When pacing is no longer indicated, the decision on management strategy should be based on an individual riskbenefit analysis in a shared decision-making process together with the patient. I C

aClass of recommendation. bLevel of evidence. Table 13 Frequency of follow-up for routine pacemaker and cardiac resynchronization therapy, either in person alone or combined with remote device management

In-office only In-office 1 remote

All devices Within 72 h and 212 weeks after

implantation In-office within 72 h and 212 weeks after

implantation

CRT-P or HBP Every 6 months Remote every 6 months and in-office every 12 monthsa Single/dualchamber Every 12 months then every

3 - 6 months at signs of battery depletion Remote every 6 months and

in-office every 18 - 24 monthsa

CRT-P = cardiac resynchronization therapy-pacemaker; HBP = His bundle pacing. aRemote follow-up can only replace in-office visits if automatic capture threshold algorithms perform accurately (and are previously verified in-office). Note: additional in-office follow-up may be required (e.g. to verify the clinical effect of modification of programming, or for follow-up a technical issue). Remote monitoring (i.e. of pre-defined alerts) should be implemented in all instances along with remote follow-ups.

ESC 2021 ESC 2021

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