Publications

BACKGROUND: Older recipients of implantable cardioverter-defibrillators (ICDs) are at increased risk for short-term mortality in comparison with younger patients. Although hospice use is common among decedents aged >65, its use among older ICD recipients is unknown.

METHODS AND RESULTS: Medicare patients aged >65 matched to data in the National Cardiovascular Data Registry - ICD Registry from January 1, 2006 to March 31, 2010 were eligible for analysis (N=194 969). The proportion of ICD recipients enrolled in hospice, cumulative incidence of hospice admission, and factors associated with time to hospice enrollment were evaluated. Five years after device implantation, 50.9% of patients were either deceased or in hospice. Among decedents, 36.8% received hospice services. The cumulative incidence of hospice enrollment, accounting for the competing risk of death, was 4.7% (95% confidence interval [CI], 4.6%-4.8%) within 1 year and 21.3% (95% CI, 20.7%-21.8%) at 5 years. Factors most strongly associated with shorter time to hospice enrollment were older age (adjusted hazard ratio, 1.77; 95% CI, 1.73-1.81), class IV heart failure (versus class I; adjusted hazard ratio, 1.79; 95% CI, 1.66-1.94); ejection fraction <20 (adjusted hazard ratio, 1.57; 95% CI, 1.48-1.67), and greater hospice use among decedents in the patients' health referral region.

CONCLUSIONS: More than one-third of older patients dying with ICDs receive hospice care. Five years after implantation, half of older ICD recipients are either dead or in hospice. Hospice providers should be prepared for ICD patients, whose clinical trajectories and broader palliative care needs require greater focus.

BACKGROUND: The effectiveness of implantable cardioverter-defibrillators (ICDs) for primary prevention of sudden death in patients with an ejection fraction (EF) ≤ 35% and clinical heart failure is well established. However, outcomes after replacement of the ICD generator in patients with recovery of EF to >35% and no previous therapies are not well characterized.

METHODS AND RESULTS: Between 2001 and 2011, generator replacement was performed at 2 tertiary medical centers in 253 patients (mean age, 68.3 ± 12.7 years; 82% men) who had previously undergone ICD placement for primary prevention but subsequently never received appropriate ICD therapy. EF had recovered to > 35% in 72 of 253 (28%) patients at generator replacement. During median (quartiles) follow-up of 3.3 (1.8-5.3) years after generator replacement, 68 of 253 (27%) experienced appropriate ICD therapy. Patients with EF ≤ 35% were more likely to experience ICD therapy compared with those with EF > 35% (12% versus 5% per year; hazard ratio, 3.57; P = 0.001). On multivariable analysis, low EF predicted appropriate ICD therapy after generator replacement (hazard ratio, 1.96 [1.35-2.87] per 10% decrement; P = 0.001). Death occurred in 25% of patients 5 years after generator replacement. Mortality was similar in patients with EF ≤ 35% and > 35% (7% versus 5% per year; hazard ratio, 1.10; P = 0.68). Atrial fibrillation (3.24 [1.63-6.43]; P < 0.001) and higher blood urea nitrogen (1.28 [1.14-1.45] per increase of 10 mg/dL; P < 0.001) were associated with mortality.

CONCLUSIONS: Although approximately one fourth of patients with a primary prevention ICD and no previous therapy have EF >35% at the time of generator replacement, these patients continue to be at significant risk for appropriate ICD therapy (5% per year). These data may inform decisions on ICD replacement.

Resource systems with enforced rules and strong monitoring systems typically have more predictable resource abundance, which can confer economic and social benefits to local communities. Co-management regimes demonstrate better social and ecological outcomes, but require an active role by community members in management activities, such as monitoring and enforcement. Previous work has emphasized understanding what makes fishermen comply with rules. This research takes a different approach to understand what influences an individual to enforce rules, particularly sea tenure. We conducted interviews and used multiple regression and Akaike's Information Criteria model selection to evaluate the effect of social networks, food security, recent catch success, fisherman's age and personal gear investment on individual's enforcement of sea tenure. We found that fishermen's enforcement of sea tenure declined between the two time periods measured and that social networks, age, food security, and changes in gear investment explained enforcement behavior across three different communities on Nicaragua's Atlantic Coast, an area undergoing rapid globalization.

BACKGROUND: Physical activity data are collected automatically by implantable cardioverter-defibrillators (ICDs). Though these data potentially provide a quantifiable and easily accessible measure of functional status, its relationship with survival has not been well studied.

METHODS AND RESULTS: Patients enrolled in the Boston Scientific LATITUDE remote monitoring system from 2008 to 2012 with ICDs were eligible. Remote monitoring data were used to calculate mean daily activity at baseline (30 to 60 days after implantation), and longitudinally. Cox regression was used to examine the association between survival and increments of 30 minutes/day in both (1) mean baseline activity and (2) time-varying activity, with both adjusted for demographic and device characteristics. A total of 98 437 patients were followed for a median of 2.2 years (mean age of 67.7±13.1 years; 71.7% male). Mean baseline daily activity was 107.5±66.2 minutes/day. The proportion of patients surviving after 4 years was significantly higher among those in the most versus least active quintile of mean baseline activity (90.5% vs. 50.0%; log-rank P value, <0.001). Lower mean baseline activity (i.e., incremental difference of 30-minutes/day) was independently associated with a higher risk of death (adjusted hazard ratio [AHR], 1.44; 95% confidence interval [CI], 1.427 to 1.462). Time-varying activity was similarly associated with a higher risk of death (AHR, 1.48; 95% CI, 1.451 to 1.508), indicating that a patient having 30 minutes per day less activity in a given month has a 48% increased hazard for death when compared to a similar patient in the same month.

CONCLUSIONS: Patient activity measured by ICDs strongly correlates with survival following ICD implantation.

BACKGROUND: As implantable cardioverter-defibrillator technology evolves, clinicians and patients need reliable performance data on current transvenous implantable cardioverter-defibrillator systems. In addition, real-world reliability data could inform postmarket surveillance strategies directed by regulators and manufacturers.

METHODS AND RESULTS: We evaluated Medtronic Sprint Quattro, Boston Scientific Endotak, and St Jude Medical Durata and Riata ST Optim leads implanted by participating center physicians between January 1, 2006 and September 1, 2012. Our analytic sample of 2653 patients (median age 65, male 73%) included 445 St Jude, 1819 Medtronic, and 389 Boston Scientific leads. After a median of 3.2 years, lead failure was 0.28% per year (95% CI, 0.19 to 0.43), with no statistically significant difference among manufacturers. Simulations based on these results suggest that detecting performance differences among generally safe leads would require nearly 10 000 patients or very long follow-up.

CONCLUSIONS: Currently marketed implantable cardioverter-defibrillator leads rarely fail, which may be reassuring to clinicians advising patients about risks and benefits of transvenous implantable cardioverter-defibrillator systems. Regulators should consider the sample size implications when designing comparative effectiveness studies and evaluating new technology for preventing sudden cardiac death.

BACKGROUND: Despite the widespread use of implantable cardioverter-defibrillators (ICDs) in clinical practice, concerns exist regarding ICD lead durability. The performance of specific lead designs and factors determining this in large populations need clarification.

METHODS AND RESULTS: The Medline, Embase, and Cochrane Collaboration databases were searched for studies including ≥2 of the most commonly implanted leads. The Mantel-Haenszel random-effects model was used. Seventeen studies were selected, including a total of 49 871 patients-5538 implanted with Durata (St. Jude Medical Inc), 10 605 with Endotak Reliance (Boston Scientific), 16 119 with Sprint Quattro (Medtronic Corp), 11 709 with Sprint Fidelis (Medtronic Corp), and 5900 with Riata (St. Jude Medical Inc)-with follow-up of 136 509 lead-years. Although the Durata lead presented a numerically higher rate, no statistically significant differences in the mean incidence of lead failure (0.29%-0.45% per year) were observed in comparison of the 3 nonrecalled leads. A higher event rate was documented with the Riata (1.0% per-year increase) and Sprint Fidelis (>2.0% per-year increase) leads compared with nonrecalled leads. An indication of increased incidence of Durata lead failure versus Sprint Quattro and Endotak Reliance leads was observed in 1 of 3 included studies, allowing for comparison of purely electrical lead failure, but this requires further evaluation.

CONCLUSIONS: Endotak Reliance (8F), Sprint Quattro (8F), and Durata (7F) leads displayed low annual incidence of failure; however, long-term follow-up data are still scarce. More data are needed to clarify the performance and safety of the Durata lead.