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Kusumoto et al 2018 Bradycardia Clinical Practice Guidelines

August 20, 2019 Circulation. 2019;140:e382–e482. DOI: 10.1161/CIR.0000000000000628 e448

CLINICAL STATEMENTS AND GUIDELINES Synopsis

In approximately 0.15% to 0.3% of patients with seizures, profound bradycardia can be observed and is often referred to as ictal asystole.S8.4.1-1–S8.4.1-3 Bradycardia can be attributable to either sinus node arrest or complete heart block and is most commonly associated with temporal lobe source of seizures.S8.4.1-1–S8.4.1-4 Rate support in patients with profound bradycardia during seizures could theoretically attenuate the severity of associated syncope.

Recommendation-Specific Supportive Text

1.	Permanent pacing has been evaluated in small numbers of patients with significant bradycardia associated with seizures identified from large databases.S8.4.1-1–S8.4.1-3 Although bradycardia is most commonly defined as a pause >3 seconds and a 2-fold increase in the preceding R-R interval, in practice the pauses have been much longer, commonly with durations >10 seconds, and 1 study found that syncope only occurred with asystole >6 seconds. In these studies with limited follow-up pacing appears to be beneficial for reducing syncope symptoms associated with seizures.S8.4.1-1–S8.4.1-4 Effective treatment of seizures with antiepileptic medications or surgery also appears to reduce the likelihood of bradycardiainduced syncope and should be considered before implanting a PPM.S8.4.1-4,S8.4.1-5 Rate support with a PPM will not affect any accompanying vasodepressor effect associated with the seizure.

9 EVALUATION OF THE RISKS FOR

VENTRICULAR ARRHYTHMIAS IN PATIENTS WHO REQUIRE PERMANENT PACING

Recommendation for Management of Bradycardia and Conduction Tissue Disease in Patients Who Require Pacing Therapy and May Also Be at Risk for Ventricular Arrhythmias Referenced studies that support the recommendation are summarized in Online Data Supplement 56.

COR LOE Recommendation

I B-NR 1.  In patients who require permanent pacing therapy, before implantation, an assessment of the risk of future ventricular arrhythmias and need for an ICD should be performed.S9-1–S9-7

Synopsis

Some patients who require or may benefit from pacing therapy may also be at risk for ventricular arrhythmias and should be considered for a device that provides treatment for bradycardia and/or conduction tissue disease and also ICD therapies.S9-8,S9-9 For example, patients with symptomatic bradycardia caused by atrioventricular block who also have heart failure symptoms and an LVEF of ≤35%, myotonic dystrophy, lamin A/C cardiomyopathy, cardiac sarcoidosis, or hypertrophic cardiomyopathy are at increased risk of ventricular arrhythmias and sudden cardiac death and might benefit from a device that has antitachycardia pacing or defibrillation capabilities.S9-1,S9-5–S9-9 Although an ICD is designed for treatment of sustained ventricular arrhythmias, ICDs are associated with increased risk of complications compared with PPMs and in some cases the prognosis is dominated by nonarrhythmia-related sequelae of the underlying disease.S9-2–S9-4,S9-6

Recommendation-Specific Supportive Text

1.	Some patients who require or may benefit from pacing therapy may also be at risk for ventricular arrhythmias and an ICD should be considered.S9-1–

S9-7 Before implantation of a cardiac device for treatment of symptoms associated with bradycardia or conduction tissue disease, a separate evaluation for potential risk of sudden cardiac death attributable to ventricular arrhythmias should be performed. Final device choice should be made after comprehensive discussion of the relative benefits and risks and an individualized choice based on shared decision-making principles.S9-9

10 COST AND VALUE

CONSIDERATIONS

Pacemaker costs can be challenging to characterize, because of variability in both charges, reimbursement, and device type (single versus dual chamber, presence of ICD or CRT capabilities); the Center for Medicare & Medicaid Services reports by state that charges vary from $20 753 to $78 140, and reimbursement varies from $11 411 to $19 577 in the United States, and systems with >1 lead are more expensive than simpler single-chamber systems.S10-1 Calculation of the incremental cost-effectiveness of dual chamber pacing systems over single-chamber systems varies both by the specific estimates of benefit in terms of cost and the quality-adjusted life years gained.S10-2–S10-6 In the United States, based on data from the MOST trial, the short-term incremental cost-effectiveness ratio (difference in cost between 2 therapies divided by the difference in their effect) or incremental cost-effectiveness ratio for a dual chamber pacemaker over a single-chamber device was $53 000, but considered over a lifetime, the incremental costeffectiveness ratio was $6 800 per quality-adjusted life

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