More than 50,000 implantable cardioverter-defibrillators (ICDs) are placed annually in patients aged >65. Demographic trends and the associated burden of heart disease will make millions more older cardiac patients eligible for these devices in the coming years. These patients face important uncertainties regarding their clinical course and health care needs after ICD implantation, which must be weighed against the risk of sudden death without the device. Two of the most challenging and costly health care transitions for older patients include nursing home (NH) and hospice admission. Which ICD recipients ultimately require NH or hospice care, and when, is entirely unknown. Additionally, their broader end-of-life experiences have not been well- characterized. This proposal addresses knowledge gaps related to the clinical course, health care needs, and end-of-life experiences of older ICD patients using 2 complementary approaches. First, data in the National Cardiovascular Data Registry - ICD Registry from 2005 to 2010 will be linked to Minimum Data Set and Medicare data to examine the utilization patterns and outcomes of older ICD patients needing NH and hospice care following ICD implantation. Second, primary data will be collected from ICD patients >65 at the Beth Israel Deaconess Medical Center to examine key end-of-life outcomes unavailable in the secondary dataset.
The Specific Aims are: 1: To describe the incidence and identify baseline risk factors for (a) long-term NH care and (b) hospice admission among ~ 300,000 ICD recipients >65 up to 3 years after ICD implantation;2: To describe and compare outcomes among ICD recipients, including: a) survival following implantation for those who were and were not admitted to NHs, and (b) i. burdensome transitions (hospitalization or NH admission) in last 90-days of life and ii. site of death for decedents (N~ 90,000) who were and were not admitted to hospice;and 3: To conduct a 2-year pilot prospective study among 75 ambulatory ICD patients >65 to ascertain the following: advance care planning (e.g. formal power of attorney for health care;advance directives;discussions with providers);main goal of care (e.g. life prolongation vs. comfort);health service use (e.g. hospitalizations, hospice, NH);and end-of-life outcomes (site, ICD shocks/deactivation, interventions, hospice use) and quality of end-of-life care (Toolkit After-death Bereaved Family Interview) among those who die (N~20). IMPACT: This research will yield novel data about the clinical course, health care needs and end- of-life experiences of older patients with ICDs.
Aims 1 and 2 will leverage national databases to examine the incidence and outcomes of older ICD patients needing long-term NH and hospice care post-implantation.
Aim 3 will establish the feasibility of conducting a prospective study of older ICD patients and yield preliminary data regarding their end-of-life experiences. This work represents key steps towards better informing clinical and policy decisions regarding the use of ICDs among older patients.
Implantable cardioverter-defibrillators (ICDs) are commonly inserted in older patients, yet the benefits to these patients remain unclear. This research will yield novel data about the clinical course, health care needs, and end-of-life experiences of older patients with ICDs using two complementary methodologies. First, national databases will be used to describe the incidence and outcomes of long-term nursing home admission and hospice care following ICD placement in older patients. Second, a pilot prospective study collecting primary data from older patients with ICDs will examine outcomes related to end-of-life experiences. This work represents key steps towards better informing clinical and policy decisions regarding the use of ICDs among older patients.
|Rome, Benjamin N; Kramer, Daniel B; Kesselheim, Aaron S (2014) Approval of high-risk medical devices in the US: implications for clinical cardiology. Curr Cardiol Rep 16:489|
|Kramer, Daniel B; Kennedy, Kevin F; Spertus, John A et al. (2014) Mortality risk following replacement implantable cardioverter-defibrillator implantation at end of battery life: results from the NCDR. Heart Rhythm 11:216-21|
|Kramer, Daniel B; Tan, Yongtian T; Sato, Chiaki et al. (2014) Ensuring medical device effectiveness and safety: a cross--national comparison of approaches to regulation. Food Drug Law J 69:1-23, i|
|Rome, Benjamin N; Kramer, Daniel B; Kesselheim, Aaron S (2014) FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012. JAMA 311:385-91|