Table 2.
(e-only) Final ranking of future research needs for ICD in older patients*
| Question | Score | Stakeholders, n | Perspectives† |
|---|---|---|---|
| Top tier | |||
| 1. What is the safety and effectiveness of primary prevention ICDs in older patient subgroups not included or not well represented in clinical trials (e.g., patients with multiple comorbidities, patients with advanced kidney disease, age > 80, etc.)?* | 20 | 10 | 3 patients, 7 providers, 2 policymakers, 2 PIs |
| 2. What are the predictors of SCD vs. those of non-SCD in older primary prevention ICD patients, i.e., at what level of competing (non-SCD) mortality risk are ICDs no longer effective in reducing all-cause mortality? | 15 | 9 | 1 patient, 7 providers, 2 policymakers, 5 PIs |
| 3. How do ICD shocks, ICD use and follow-up, and complications of ICD use affect survival and quality of life in older patients? Does the impact vary by age, gender, or comorbidity status?* | 15 | 9 | 4 patients, 4 providers, 4 policymakers, 3 PIs |
| 4. Does facilitated shared decision-making with older patients, their families or caregivers, and their providers affect ICD treatment choices and prevention of sudden cardiac death outcomes?‡ | 15 | 8 | 4 patients, 4 providers, 2 policymakers, 4 PIs |
| 5. Are there disparities in ICD referrals in older patients by sex, race, or ethnicity?‡ | 13 | 6 | 1 patient, 5 providers, 2 policymakers, 1 product maker, 2 PIs |
| 6. What is the comparative safety and effectiveness of risk stratification strategies in older patients for SCD beyond using LVEF?* | 12 | 6 | 1 patient, 6 providers, 2 PIs |
| 7. What are effective methods to reduce health care disparities in the use of primary (or secondary) prevention ICDs in older patients? | 12 | 6 | 1 patient, 5 providers, 3 policymakers, 1 product maker, 1 PI |
| 8. What are patient preferences regarding improved survival from ICDs at the possible cost of comorbidities/complications/suffering vs. shorter survival but with quick and “painless” death?‡ | 12 | 6 | 2 patients, 4 providers, 1 policymaker, 3 PIs |
| 9. What is the comparative safety and effectiveness of available devices (transvenous single-chamber ICD, transvenous dual-chamber ICD, subcutaneous ICD) for an individual older patient based on his/her age, underlying heart disease and the presence of other diseases?* | 11 | 7 | 3 patients, 5 providers, 1 policymaker, 1 product maker, 4 PIs |
| 10. What is the effect of ICD intervention on universal geriatric outcomes such as quality of life, physical activity, independence, fatigue and frailty?‡ | 10 | 8 | 2 patients, 6 providers, 1 policymaker, 5 PIs |
| 11. Is there an upper age limit beyond which it becomes futile to expect a benefit from an ICD, i.e., where the increase in survival is minimal compared to patients without an ICD, and there is no or minimal increase in quality-adjusted life years?‡ | 10 | 6 | 5 providers, 1 policymaker, 2 PIs |
| 12. What is the distribution of modes of death in older patients who are eligible for a primary (or secondary) prevention ICD? | 9 | 6 | 1 patient, 5 providers, 1 policymaker, 4 PIs |
| Middle tier | |||
| 13. What patient-reported outcome metrics for quality of life and device adjustment are most informative in ICD research trials of older patients?‡ | 9 | 5 | 1 patient, 3 providers, 3 PIs |
| 14. What is the comparative safety and effectiveness of remote monitoring of ICD devices versus standard clinic visits for older patients seen in clinical practice? | 9 | 4 | 2 patients, 3 providers, 2 product makers, 2 PIs |
| 15. What is the comparative effectiveness of available methods to enhance communication about ICD deactivation as an ongoing process that starts prior to implant and continues over time as patients’ health status and goals of care change? | 9 | 4 | 1 patient, 3 providers, 1 policymaker, 1 PI |
| 16. Is there a role for subcutaneous ICDs in older patients with a primary or secondary prevention indication for the device?* | 8 | 5 | 1 patient, 4 providers, 1 product maker, 3 PIs |
| 17. What is the comparative effectiveness of various decision support tools to assist patients, caregivers, and providers in determining the appropriate timing for ICD deactivation?‡ | 8 | 5 | 2 patients, 3 providers, 1 policymaker, 1 PI |
| 18. How do we optimize the safety of ICDs and leads in older patients?* | 8 | 4 | 1 patient, 2 providers, 2 PIs |
| 19. What factors influence ICD remote monitoring adoption and utilization in older patients?‡ | 8 | 3 | 1 patient, 3 providers, 2 product makers, 3 PIs |
| 20. What patient-centered or comorbidity-specific outcomes influence the overall effectiveness of ICDs in older adults?* ‡ | 7 | 5 | 4 providers, 1 policymaker, 3 PIs |
| 21. What is the clinical effectiveness and safety of ICD replacements in older patients who have not had an appropriate shock?‡ | 7 | 5 | 1 patient, 4 providers, 1 policymaker, 3 PIs |
| 22. What is the additional value of novel markers (like genetic markers, MRI findings, and biomarkers) to predictive models that utilize clinical and mostly conventional risk factors for the prediction of SCD in older patients? | 7 | 4 | 4 providers, 2 policymakers, 1 PI |
| 23. What is the current utilization of ICDs in eligible patients > 65? What are the barriers to utilization?*‡ | 7 | 4 | 4 providers, 1 policymaker, 1 product maker, 2 PIs |
| 24. What are patient preferences regarding communications from their health care providers about the benefits and burdens of device therapy and how they might align with their desired outcomes for their health care?* | 7 | 4 | 2 patients, 2 providers, 1 policymaker, 1 PI |
| 25. What evidence is needed to better enable a patient-centric approach to end-of-life decision-making for ICD recipients?‡ | 7 | 3 | 2 patients, 2 providers, 1 product maker, 1 PI |
| 26. Are there sex differences in any of the above safety and effectiveness questions regarding ICD therapy in older patients?‡ | 5 | 3 | 2 patients, 2 providers, 1 policymaker, 1 PI |
| 27. What is the effect of ICD intervention on cognitive trajectory in persons with mild cognitive impairment/early dementia?‡ | 4 | 4 | 1 patient, 2 providers, 1 policymaker, 1 PI |
| 28. What is the comparative safety and effectiveness of strategies to minimize short- and long-term complications of ICDs in older patients receiving these devices? | 4 | 3 | 1 patient, 2 providers, 2 PIs |
| 29. How does remote monitoring of ICDs in older patients impact patient outcomes including quality of life and activity?‡ | 4 | 2 | 1 patient, 1 providers, 1 policymaker, 1 product maker, 1 PI |
| 30. Do specific types of patient comorbidities affect older patients’ acceptance of ICD therapy and/or provider willingness to recommend?*‡ | 4 | 2 | 1 patient, 2 providers, 1 product maker, 2 PIs |
| 31. Is the beneficial effect of the ICD in older patients durable beyond the limited follow-up period of existing clinical trials?* | 3 | 3 | 3 providers, 1 policymaker |
| 32. What is the clinical effectiveness and safety of ICD replacements in older patients who have improved ejection fraction?*‡ | 3 | 2 | 2 providers, 1 PI |
| 33. What are the most effective, patient-centered strategies to reduce anxiety associated with ICD shocks/fear of shocks?*‡ | 3 | 1 | 1 provider, 1 PI |
| Lower tier | |||
| 34. Does higher frequency of prior heart failure hospitalizations identify a cohort of older patients who will derive less benefit from ICD therapies?‡ | 2 | 2 | 1 provider, 1 policymaker, 1 PI |
| 35. What are the predictors of appropriate ICD shocks in older patients with a secondary prevention ICD?‡ | 2 | 2 | 1 patient, 2 providers, 2 PIs |
| 36. How do the outcomes of “optimal programming of ICDs” as demonstrated by recent randomized clinical trials in older patients seen in clinical practice compare to those observed in those clinical trials? | 2 | 2 | 1 patient, 1 policymaker, 1 PI |
| 37. What is the comparative safety and effectiveness of optimally programmed single-chamber ICDs as compared to optimally programmed dual-chamber ICDs in older patients? | 2 | 2 | 1 patient, 2 providers, 2 PIs |
| 38. What is the most effective, patient-centered management strategy in older ICD patients when devices or leads are recalled?* | 2 | 2 | 2 patients, 1 policymaker |
| 39. What is the most effective, patient-centered management strategy for older ICD patients with bloodstream or other serious infections?‡ | 2 | 2 | 2 providers, 1 PI |
| 40. How can the appropriate utilization of primary prevention ICDs in older patients seen in clinical practice be enhanced? | 2 | 2 | 2 providers, 1 PI |
| 41. What data from device interrogations are older patients most interested in possessing and why?*‡ | 2 | 1 | 1 provider, 1 product maker, 1 PI |
| 42. What are the predictors of appropriate ICD shocks in older patients with non-ischemic cardiomyopathy with a primary prevention ICD?‡ | 1 | 1 | 1 patient, 1 provider, 1 PI |
| 43. What are the predictors of appropriate ICD shocks in older patients with ischemic heart disease with a primary prevention ICD?‡ | 1 | 1 | 1 patient, 1 provider, 1 PI |
| 44. What is the influence of the caretaker on an older patient’s health management and outcomes related to the prevention of sudden cardiac death and ICD therapy?*‡ | 1 | 1 | 1 patient |
| 45. Are there socioeconomic factors that differentiate effectiveness of ICD therapy recommendation or patient acceptance in older patients, e.g., primary caregiver status, living situation (alone or group setting), family circumstances, etc.?‡ | 1 | 1 | 1 provider, 1 PI |
| 46. What changes in patient circumstances would alter older patients’ acceptance of ICD therapy?‡ | 1 | 1 | 1 provider, 1 PI |
| 47. Does obesity in older patients influence ICD effectiveness or safety?‡ | 0 | 0 | – |
| 48. In older patients with ICDs, what are the clinical benefits and risks of the currently used longer-lasting devices?‡ | 0 | 0 | – |
* “Older patients” are defined as patients 75 years of age and older, except in questions flagged with an asterisk (*), which apply to patients 65 years of age and older
† “Perspectives” indicates the self-reported perspectives represented by the stakeholders who voted for the individual evidence gaps. Note that an individual stakeholder could self-identify as representing more than one perspective (i.e., could self-identify as both a patient and a provider); for this reason, the number of perspectives does not necessarily equal the number of stakeholders
‡ Indicates evidence gaps that were added or substantially revised by stakeholders
Abbreviations: ICD(s) implantable cardioverter defibrillator(s), LVEF left ventricular ejection fraction, MRI magnetic resonance imaging, n number (of stakeholders), PI(s) principal investigator(s), SCD sudden cardiac death