Future Research Prioritization: Implantable Cardioverter-Defibrillator Therapy in Older Patients

Abstract

BACKGROUND: Although the implantable cardioverterdefibrillator (ICD) is highly effective therapy for preventing sudden cardiac death, there is considerable uncertainty about its benefits and harms in older patients, especially in the presence of factors, other than old age, that increase the risk of death. OBJECTIVE: To develop a prioritized research agenda for the Patient-Centered Outcomes Research Institute as informed by a diverse group of stakeholders on the use and outcomes of the ICD in older patients. DESIGN: The existing literature was reviewed to identify evidence gaps, which were then refined by engaged stakeholders. Using a forced-ranking prioritization method, the stakeholders ranked evidence gaps by importance. For the highest-ranked evidence gaps, relevant recent studies were identified using PubMed, and relevant ongoing trials were identified using ClinicalTrials.gov. PARTICIPANTS: Eighteen stakeholders, including clinical experts and researchers in the prevention of sudden cardiac death and ICD therapy, representatives from federal and non-governmental funding agencies, representatives from relevant professional societies, health care decision-makers and policymakers, and representatives from related consumer and patient advocacy groups KEY RESULTS: The top 12 evidence gaps prioritized by stakeholders were related to the safety and effectiveness of ICDs in older patient subgroups not well represented in clinical trials, predictors of SCD, the impact of the ICD on quality of life, the use of shared decision-making, disparities in ICD use, risk stratification strategies, patient preferences, and distribution of modes of death in older patients. CONCLUSIONS: In this paper, we identify evidence gaps of high priority for current and future investigations of ICD therapy. Addressing these gaps will likely resolve many of the uncertainties surrounding the use and outcomes of the ICD in older patients seen in clinical practice.KEY WORDS: stakeholder engagement; cardiovascular disease; decision making.

When Is It Safe Not to Reimplant an Implantable Cardioverter Defibrillator at the Time of Battery Depletion?

“…20,26 This uncertainty is amplified in patients ≥65 years of age in whom the burden of comorbid diseases and competing modes of death reduce ICD benefit. 26,27 Although many studies have defined the risks associated with ICD generator replacement, 28,29 there are currently no studies that have examined whether or not this invasive procedure leads to any benefit among these lower-risk patients.…”

“…The results identified “clinical effectiveness and safety of ICD replacements in older patients who have not had an appropriate shock or those with improved LVEF” as a key research priority for PCORI. 26 …”

The relationship between baseline and follow-up left ventricular ejection fraction with adverse events among primary prevention ICD patients

“…There are limited data on the prognostic implications of LVEF change over time, particularly as it pertains to the risk for ventricular arrhythmias, and there are currently no guidelines to aid in clinical decision making. (7,8) Based on this important evidence gap, we performed an analysis assessing the clinical utility of long-term follow-up LVEF in a primary prevention ICD population to determine the relative clinical value of baseline and follow-up LVEF in estimating the risk for the following adverse clinical outcomes: left ventricular assist device implantation (LVAD), transplant, death, and ICD therapy.…”

Capsule Commentary on Al-Khatib et al., Future Research Prioritization: Implantable Cardioverter Defibrillator Therapy in Older Patients

“…4 Through the engagement of 18 stakeholders representing different perspectives and a forced-ranking prioritization method, they identified 12 areas of evidence gaps, which included the safety and effectiveness of ICDs in the elderly, the outcomes associated with different ICD devices, different modes of death or predictors of SCD in the elderly, the impact of ICDs on the quality of life, patient preferences regarding ICD implantation, and the shared decision-making process. 4 In order to reduce the waste of resources, it is crucial to clearly identify and prioritize research needs 5 using qualitative and quantitative research methods to cover both the depth and breadth of these gaps. The research priorities identified by AlKhatib and colleagues 4 could contribute to reducing some of the concerns in SCD prevention, but also to creating focused funding opportunities.…”

“…4 In order to reduce the waste of resources, it is crucial to clearly identify and prioritize research needs 5 using qualitative and quantitative research methods to cover both the depth and breadth of these gaps. The research priorities identified by AlKhatib and colleagues 4 could contribute to reducing some of the concerns in SCD prevention, but also to creating focused funding opportunities.…”