Person:

Hatfield, Laura

Background: Cardiac implantable electric devices are commonly used to treat heart failure. Little is known about temporal and geographic variation in use of cardiac resynchronization therapy (CRT) devices in usual care settings. Methods and Results: We identified new CRT with pacemaker (CRT‐P) or defibrillator generators (CRT‐D) implanted between 2008 and 2013 in the United States from a commercial claims database. For each implant, we characterized prior medication use, comorbidities, and geography. Among 17 780 patients with CRT devices (median age 69, 31% women), CRT‐Ps were a small and increasing share of CRT devices, growing from 12% to 20% in this study period. Compared to CRT‐D recipients, CRT‐P recipients were older (median age 76 versus 67), and more likely to be female (40% versus 30%). Pre‐implant use of β‐blockers and angiotensin‐converting enzyme inhibitors or angiotensin II receptor blockers was low in both CRT‐D (46%) and CRT‐P (31%) patients. The fraction of CRT‐P devices among all new implants varied widely across states. Compared to the increasing national trend, the share of CRT‐P implants was relatively increasing in Kansas and relatively decreasing in Minnesota and Oregon. Conclusions: In this large, contemporary heart failure population, CRT‐D use dwarfed CRT‐P, though the latter nearly doubled over 6 years. Practice patterns vary substantially across states and over time. Medical therapy appears suboptimal in real‐world practice.

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.

Meta‐analysis of individual participant data (IPD) is increasingly utilised to improve the estimation of treatment effects, particularly among different participant subgroups. An important concern in IPD meta‐analysis relates to partially or completely missing outcomes for some studies, a problem exacerbated when interest is on multiple discrete and continuous outcomes. When leveraging information from incomplete correlated outcomes across studies, the fully observed outcomes may provide important information about the incompleteness of the other outcomes. In this paper, we compare two models for handling incomplete continuous and binary outcomes in IPD meta‐analysis: a joint hierarchical model and a sequence of full conditional mixed models. We illustrate how these approaches incorporate the correlation across the multiple outcomes and the between‐study heterogeneity when addressing the missing data. Simulations characterise the performance of the methods across a range of scenarios which differ according to the proportion and type of missingness, strength of correlation between outcomes and the number of studies. The joint model provided confidence interval coverage consistently closer to nominal levels and lower mean squared error compared with the fully conditional approach across the scenarios considered. Methods are illustrated in a meta‐analysis of randomised controlled trials comparing the effectiveness of implantable cardioverter‐defibrillator devices alone to implantable cardioverter‐defibrillator combined with cardiac resynchronisation therapy for treating patients with chronic heart failure. © 2016 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd.

Despite the recent proliferation of price transparency tools, consumer use and awareness of these tools is low. Better strategies to increase the use of price transparency tools are needed. To inform such efforts, we studied who is most likely to use a price transparency tool. We conducted a cross-sectional study of use of the Truven Treatment Cost Calculator among employees at 2 large companies for the 12 months following the introduction of the tool in 2011-2012. We examined frequency of sign-ons and used multivariate logistic regression to identify which demographic and health care factors were associated with greater use of the tool. Among the 70 408 families offered the tool, 7885 (11%) used it at least once and 854 (1%) used it at least 3 times in the study period. Greater use of the tool was associated with younger age, living in a higher income community, and having a higher deductible. Families with moderate annual out-of-pocket medical spending ($1000-$2779) were also more likely to use the tool. Consistent with prior work, we find use of this price transparency tool is low and not sustained over time. Employers and payers need to pursue strategies to increase interest in and engagement with health care price information, particularly among consumers with higher medical spending.

Purpose: To date, few studies have examined end-of-life care for patients with ovarian cancer. One study documented increased hospice use among older patients with ovarian cancer from 2000 to 2005. We sought to determine whether increased hospice use was associated with less-intensive end-of-life medical care. Patients and Methods: We identified 6,956 individuals age of 66 years living in SEER areas who were enrolled in fee-for-service Medicare, diagnosed with epithelial ovarian cancer between 1997 and 2007, and died as a result of ovarian cancer by December 2007. We examined changes in medical care during patients’ last month of life over time. Results: Between 1997 and 2007, hospice use increased significantly, and terminal hospitalizations decreased (both P < .001). However, during this time, we also observed statistically significant increases in intensive care unit admissions, hospitalizations, repeated emergency department visits, and health care transitions (all P ≤ .01). In addition, the proportion of patients referred to hospice from inpatient settings rose over time (P=.001). Inpatients referred to hospice were more likely to enroll in hospice within 3 days of death than outpatients (adjusted odds ratio, 1.36; 95% CI, 1.12 to 1.66). Conclusion: Older women with ovarian cancer were more likely to receive hospice services near death and less likely to die in a hospital in 2007 compared with earlier years. Despite this, use of hospital-based services increased over time, and patients underwent more transitions among health care settings near death, suggesting that the increasing use of hospice did not offset intensive end-of-life care.