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Kusumoto et al 2018 Bradycardia Clinical Practice Guidelines

Circulation. 2019;140:e382–e482. DOI: 10.1161/CIR.0000000000000628 August 20, 2019 e449 CLINICAL STATEMENTS AND GUIDELINES

year.S10-6 In large part driven by data from the DANPACE (The Danish Multicenter Randomised Study on AAI Versus DDD Pacing in Sick Sinus Syndrome) trial,S10-7 dual chamber devices in another study were found to be more cost-effective than single-chamber devices across a range of “willingness to pay” thresholds and in most scenarios, especially in elderly patients with greater burden of comorbidity,S10-8 primarily because of a >20% risk of reoperation for pacemaker syndrome among patients with single-chamber devices.

11 SHARED DECISION-MAKING

Recommendations for Shared Decision-Making for Pacemaker Implantation in the Setting of Guideline-Based Indications for Bradycardia Pacing

COR LOE Recommendations

I C-LD 1.  In patients with symptomatic bradycardia or conduction disorder, clinicians and patients should engage in a shared decision-making approach in which treatment decisions are based not only on the best available evidence, but also on the patient’s goals of care, preferences, and values.S11-1–S11-6

I C-LD 2.  Patients considering implantation of a pacemaker or with a pacemaker that requires lead revision or generator change should be informed of procedural benefits and risks, including the potential short- and longterm complications and possible alternative therapy, if any, in light of their goals of care, preferences, and values.S11-1–S11-6

III: No Benefit C-LD 3.  In patients with indications for permanent pacing but also with significant comorbidities such that pacing therapy is unlikely to provide meaningful clinical benefit, or if patient goals of care strongly preclude pacemaker therapy, implantation or replacement of a pacemaker should not be performed.S11-1–S11-6

Synopsis

The decision to implant a pacemaker should be shared between the patient and clinicians, using the principles of shared decision-making, and based on the clinical indications, consideration of individualized risks and benefits based on comorbidities and overall prognosis, and the patient’s preferences and goals of care. The potential consequences and potential future lead management issues (if applicable) should be discussed with the patient and family along with potential considerations at end of life.S11-7,S11-8

Recommendation-Specific Supportive Text

1.	 Consideration of patient preferences is essential for management decisions. Patient preferences for and acceptance of procedural and long-term risks and benefits of invasive therapies vary and may evolve throughout the course of their illness. The bradycardia guideline writing committee endorses shared decision-making as part of the general care for patients with symptomatic bradycardia. A commonly accepted definition of shared decision-makingS11-9 includes 4 components: 1) at least 2 participants, the clinician and patient; 2) both participants share information with each other; 3) both parties build a consensus about the preferred treatment; and 4) an agreement is reached on the treatment to implement. Sharing a decision does not mean giving a patient a list of risks and benefits and telling them to make a decision—a practice some authors have called “abandonment.”S11-10 If time permits the patient should be directed to trusted material which supports and itemizes appropriate considerations which should be factored into their decision-making. Notably, a recommendation based on evidence or guidelines alone is not shared decision-making. Rather, a recommendation based both on the evidence as well as an understanding of the patients’ health goals, preferences and values is essential to achieving true shared decision-making. 2.	 Pacemaker implantation or revision are commonly performed heart procedures and are not typically associated with high procedural risk in most patients. Nevertheless, because pacemaker implantation or revision is frequently performed in elderly patients with multiple comorbidities, frailty, and competing risks of mortality, adverse events such as pneumothorax and cardiac tamponade can complicate the procedure. A thorough discussion should take place with the patient before the procedure outlining the potential individualized, patient-specific benefits and risks, including the implications of living with an implantable electrophysiology device that includes a discussion of a patient’s health goals, preferences, and values. For some patients, pacemaker therapy may affect usability. 3.	 Patients with significant comorbid conditions may not derive the intended benefit of pacing support or an improved QOL. Similarly, in patients who are expected to have a shortened life span because of a terminal progressive illness (including advanced dementia, metastatic cancer with anticipated death in the immediate future, or similar situations with poor prognosis), the benefits of pacing support may not be realized and are unlikely to positively impact the overall outcome. Although the risks of pacemaker implantation are relatively low, the benefit-risk ratio is not favorable if the probable benefit is also quite low.S11-11 These pros and cons can be discussed with the patient and

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