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September 25, 2018 Circulation. 2018;138:e272–e391. DOI: 10.1161/CIR.0000000000000549 e352 CLINICAL STATEMENTS AND GUIDELINES Synopsis During most of their lives, people prefer to do everything possible to prevent SCD and prolong life. However, many people may get to a point in their lives where SCD is not the worst outcome. Patients may report a desire to die in their sleep.S15-6 Decisions related to SCD can be quite emotional; according to the patient’s wishes, shared decision regarding end-of-life therapy making may involve caregivers such as family members or friends. Recommendation-Specific Supportive Text 1. Consideration of patient preferences is important for VA diagnosis and management decisions. Patient preferences for invasive therapies and acceptance of SCD risk vary and may evolve throughout the course of their illness. The writing committee endorses a shared decision-making approach as part of the general care for patients at risk for VA and SCD. A commonly accepted definition of the shared decision-makingS15-7 includes 4 components: 1) at least 2 participants, the clinician and patient, be involved; 2) both parties share information; 3) both parties take steps to 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.”S15-8 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. Also, the possibility of deactivation of an existing ICD should be discussed with patients who have terminal illnesses. 2. ICDs prolong lives as highlighted in many places within this guideline. However, a patient with HF or advanced noncardiac illness may elect to forgo replacement of an ICD when faced with the prospect of continual decline in health and functional status from either progressive HF or some other competing morbidity. Unfortunately, research suggests that patients are ill-informed when faced with understanding the risks, benefits, and downstream burdens of their ICDs. Patients with an ICD tend to overestimate the benefit of this therapy and underestimate its risks.S15-1–S15-3 Likewise, patients who decline an ICD also frequently underestimate their personal risk of VA and SCD.S15-4,S15-5 Stud- ies of clinician decision-making demonstrate that clinicians often overestimate the benefits while downplaying the potential harms.S15-3 In kind, ICD replacement is also an important point in time where patients and clinicians should discuss whether replacing an ICD is still consistent with the patients’ goals. What made sense at 70 years of age may not make sense at 80 years of age. Patients may have had progressive disease or developed poor QoL. These factors can all change the risk/benefit ratio of the ICD and the patients’ preferences. 16 COST AND VALUE CONSIDERATIONS The key principles of value assessment as part of clinical practice guidelines have been discussed in detail.S16-1 Economic outcomes of clinical management strategies can be documented empirically using the same research designs as used in establishing clinical outcomes, including RCTs and observational comparisons. In addition, simulation models are often used to assess the value of management strategies, because the standard for cost-effectiveness studies is to compare life-time outcomes, and clinical studies usually have follow-up of a few years at most. Standards for economic modeling in health care have been published by an expert group.S16-2 Economic assessments of alternative management strategies for VA and prevention of SCD have primarily evaluated ICDs, including several RCTsS16-3–S16-7 and observational studies,S16-8,S16-9 and simulation models.S16-10–S16-14 In all studies, patients who received ICDs had higher long-term costs. The high initial cost of the ICD device and the implantation procedure leads to higher longterm costs, because there are few, if any, subsequent cost-savings from implanting an ICD. ICDs without resynchronization capability do not reduce hospital readmissions and may increase late costs due to device monitoring, complications, and replacement. However, the cost of the device and the procedure may change significantly over time. The trial based assessments of the cost-effectiveness of the ICD are based on 3 to 6 years of follow-up, which is considerably shorter than the lifetime perspective that is standard in cost-effectiveness models. Because most of the incremental cost of the ICD is incurred immediately, while most of the potential effectiveness (lifeyears of survival added by the ICD) is accrued over many years, estimates of ICD cost-effectiveness based on limited trial follow-up have a systematic bias toward showing lower value. Trial based economic studies that projected long-term ICD outcomes have consistently found more favorable cost-effectiveness ratios than estimates restricted to the duration of trial follow-up.S16-4–S16-7 A Downloaded from http://ahajournals.org by on October 7, 2026