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The article highlights into the challenges between Food and Drug Administration authorization and Medicare coverage for emerging medical devices, highlighting the discrepancy in regulatory standards. Topics include the struggle to balance expedited patient access and ensuring adequate evidence generation for reimbursement, as seen in the proposed Medicare Coverage of Innovative Technologies (MCIT) and Transitional Coverage for Emerging Technologies (TCET) pathways.

The article addresses the implantation of cardioverter-defibrillators (ICDs) that have been subject to Class I recalls, despite the underlying issues not being fully corrected. It mentions that an independent, multistakeholder study be conducted to better define the risk of shock failures associated with these recalled devices, and they recommend increased transparency from the manufacturer, and careful consideration by the clinical community regarding the use of such devices.

The incidence and clinical impact of lead-related venous obstruction (LRVO) among patients with cardiovascular implantable electronic devices (CIEDs) is poorly defined. The objectives of this study were to determine the incidence of symptomatic LRVO after CIED implant; describe patterns in CIED extraction and revascularization; and quantify LRVO-related health care utilization based on each type of intervention. LRVO status was defined among Medicare beneficiaries after CIED implant from October 1, 2015, to December 31, 2020. Cumulative incidence functions of LRVO were estimated by Fine-Gray methods. LRVO predictors were identified using Cox regression. Incidence rates for LRVO-related health care visits were calculated with Poisson models. Among 649,524 patients who underwent CIED implant, 28,214 developed LRVO, with 5.0% cumulative incidence at maximum follow-up of 5.2 years. Independent predictors of LRVO included CIEDs with >1 lead (HR: 1.09; 95% CI: 1.07-1.15), chronic kidney disease (HR: 1.17; 95% CI: 1.14-1.20), and malignancies (HR: 1.23; 95% CI: 1.20-1.27). Most patients with LRVO (85.2%) were managed conservatively. Among 4,186 (14.8%) patients undergoing intervention, 74.0% underwent CIED extraction and 26.0% percutaneous revascularization. Notably, 90% of the patients did not receive another CIED after extraction, with low use (2.2%) of leadless pacemakers. In adjusted models, extraction was associated with significant reductions in LRVO-related health care utilization (adjusted rate ratio: 0.58; 95% CI: 0.52-0.66) compared with conservative management. In a large nationwide sample, the incidence of LRVO was substantial, affecting 1 of every 20 patients with CIEDs. Device extraction was the most common intervention and was associated with long-term reduction in recurrent health care utilization. [Display omitted] [ABSTRACT FROM AUTHOR]

For example, although the FDA has explicitly considered proposals to "sunset certain older predicates and promote the use of more modern predicates,"[10] older predicates may also have longer track records of safety. Use of recalled devices in new device authorizations under the US Food and Drug Administration's 510(k) pathway and risk of subsequent recalls. Predicate selections represent at least in part strategic decisions made by manufacturers; it is not at all clear that banning older predicates would lead to different or more substantive testing for new medium-risk devices as opposed to simply more creative selection of predicates. [Extracted from the article]

Cardiac implantable electronic device (CIED) procedures require informed consent and, ideally, shared decision making to guide patients through their experiences as CIED recipients. The information that different patients need or want about cybersecurity risk varies. This article considers device cybersecurity risks in light of federal guidelines and suggests strategies for communicating these risks clearly during informed consent conversations and follow-up. [ABSTRACT FROM AUTHOR]

The article presents the discussion on ICD implantation within the health care. Topics include Cardiac electrophysiology therapies including implantable cardioverterdefibrillator (ICD) insertion without improving quality of life; and improving alignment of values with actual treatment choices; and improving utilization, understanding either as reduced variability in care, reducing overall use, or improving clinical outcomes in the eligible population.

The article presents a case study of a 52-year-old woman was evaluated for a wide-complex tachycardia that developed while she was hospitalized for the management of seizures. Five days before the development of tachycardia, the patient had been admitted to this hospital with tonic-clonic seizure activity. Six days before the current admission, she had been discharged from this hospital after a prolonged hospitalization in the neurosciences intensive care unit (ICU).

Globalization processes, such as market pressures, tend to encourage farmers to reduce agricultural (or agro-) biodiversity. Yet, what is known about the drivers of agrobiodiversity erosion largely comes from research from communities in which farming is the principle natural resource-based livelihood. Focusing on Caribbean Nicaragua's Pearl Lagoon Basin following the construction of the first regional road, we used a mixed methods approach to understand how the complex livelihood dynamics inherent in coastal socio-ecological systems—where households rely upon both terrestrial and aquatic resources—affect farmers' decisions to maintain agrobiodiversity. Our analyses reveal atypical spatial patterns of agrobiodiversity maintenance relative to road access: the farming systems of households most proximal to the road are significantly more agrobiodiverse than those maintained by household in distant communities. This pattern is in part explained by local livelihood dynamics. Market access associated with road development encouraged the depletion of the lagoon fishery. To buffer their food security, households' near to the road are focusing efforts on their historically biodiverse subsistence agricultural systems. These findings suggest that conservation efforts targeting coastal socio-ecological systems must account for the ways in which the complexity of natural resource-based livelihoods in these systems affect households' responses to a changing world. [ABSTRACT FROM AUTHOR]

The article discusses the potential harmonization of medical device regulation standards and incentives in the U.S., and it mentions what the authors' refer to as the lessons that have been learned from America's Parallel Review Pathway high-risk medical device review program. U.S. Food and Drug Administration (FDA) medical device approvals are examined, along with America's Centers for Medicare and Medicaid Services.

Introduction: Measurement of the spatial ventricular gradient (SVG), spatial QRST angles, and other vectorcardiographic measures of myocardial electrical heterogeneity have emerged as novel risk stratification methods for sudden cardiac death and other adverse cardiovascular events. Prior studies of normal limits of these measurements included primarily young, healthy, White volunteers, but normal limits in older patients are unknown. The influence of race and body mass index (BMI) on these measurements is also unclear. Methods: Normal 12‐lead electrocardiograms (ECGs) from a single center were identified. Patients with abnormal cardiovascular, pulmonary, or renal history (assessed by International Classification of Disease [ICD‐9/ICD‐10] codes) or abnormal cardiovascular imaging were excluded. The SVG and QRST angles were measured and stratified by age, sex, and race. Multivariable linear regression was used to assess the influence of age, BMI, and heart rate (HR) on these measurements. Results: Among 3292 patients, observed ranges of SVG and QRST angles (peak and mean) differed significantly based on sex, age, and race. Sex differences attenuated with increasing age. Men tended to have larger SVG magnitude (60.4 [46.1–77.8] vs. 52.5 [41.3–65.8] mv*ms, p <.0001) and elevation, and more anterior/negative SVG azimuth (−14.8 [−25.1 to −4.3] vs. 1.3 [−9.8 to 10.5] deg, p <.0001) compared to women. Men also had wider QRST angles. Observed ranges varied significantly with BMI and HR. SVG and QRST angle measurements were robust to different filtering bandwidths and moderate fiducial point annotation errors, but were heavily affected by changes in baseline correction. Conclusions: Age, sex, race, BMI, and HR significantly affect the range of SVG and QRST angles in patients with normal ECGs and no known cardiovascular disease, and should be accounted for in future studies. An online calculator for prediction of these "normal limits" given demographics is provided at https://bivectors.github.io/gehcalc/. [ABSTRACT FROM AUTHOR]

Background: Readmission rates after hospitalizations for heart failure (HF), acute myocardial infarction (AMI), and pneumonia among Medicare beneficiaries are used to assess quality and determine reimbursement. Whether these measures reflect readmission rates for other conditions or insurance groups is unknown. Objective: To investigate whether hospital-level 30-day readmission measures for publicly reported conditions (HF, AMI, and pneumonia) among Medicare patients reflect those for Medicare patients hospitalized for unreported conditions or non-Medicare patients hospitalized with HF, AMI, or pneumonia. Design: Cross-sectional. Setting: Population-based. Participants: Hospitals in the all-payer Nationwide Readmissions Database in 2013 and 2014. Measurements: Hospital-level 30-day all-cause risk-standardized excess readmission ratios (ERRs) were compared for 3 groups of patients: Medicare beneficiaries admitted for HF, AMI, or pneumonia (Medicare reported group); Medicare beneficiaries admitted for other conditions (Medicare unreported group); and non-Medicare beneficiaries admitted for HF, AMI, or pneumonia (non-Medicare group). Results: Within-hospital differences in ERRs varied widely among groups. Medicare reported ratios differed from Medicare unreported ratios by more than 0.1 for 29% of hospitals and from non-Medicare ratios by more than 0.1 for 46% of hospitals. Among hospitals with higher readmission ratios, ERRs for the Medicare reported group tended to overestimate ERRs for the non-Medicare group but underestimate those for the Medicare unreported group. Limitation: Medicare groups and risk adjustment differed slightly from those used by the Centers for Medicare & Medicaid Services. Conclusion: Hospital ERRs, as estimated by Medicare to determine financial penalties, have poor agreement with corresponding measures for populations and conditions not tied to financial penalties. Current publicly reported measures may not be good surrogates for overall hospital quality related to 30-day readmissions. [ABSTRACT FROM AUTHOR]

Background: Readmission rates after hospitalizations for heart failure (HF), acute myocardial infarction (AMI), and pneumonia among Medicare beneficiaries are used to assess quality and determine reimbursement. Whether these measures reflect readmission rates for other conditions or insurance groups is unknown.Objective: To investigate whether hospital-level 30-day readmission measures for publicly reported conditions (HF, AMI, and pneumonia) among Medicare patients reflect those for Medicare patients hospitalized for unreported conditions or non-Medicare patients hospitalized with HF, AMI, or pneumonia.Design: Cross-sectional.Setting: Population-based.Participants: Hospitals in the all-payer Nationwide Readmissions Database in 2013 and 2014.Measurements: Hospital-level 30-day all-cause risk-standardized excess readmission ratios (ERRs) were compared for 3 groups of patients: Medicare beneficiaries admitted for HF, AMI, or pneumonia (Medicare reported group); Medicare beneficiaries admitted for other conditions (Medicare unreported group); and non-Medicare beneficiaries admitted for HF, AMI, or pneumonia (non-Medicare group).Results: Within-hospital differences in ERRs varied widely among groups. Medicare reported ratios differed from Medicare unreported ratios by more than 0.1 for 29% of hospitals and from non-Medicare ratios by more than 0.1 for 46% of hospitals. Among hospitals with higher readmission ratios, ERRs for the Medicare reported group tended to overestimate ERRs for the non-Medicare group but underestimate those for the Medicare unreported group.Limitation: Medicare groups and risk adjustment differed slightly from those used by the Centers for Medicare & Medicaid Services.Conclusion: Hospital ERRs, as estimated by Medicare to determine financial penalties, have poor agreement with corresponding measures for populations and conditions not tied to financial penalties. Current publicly reported measures may not be good surrogates for overall hospital quality related to 30-day readmissions.Primary Funding Source: Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology. [ABSTRACT FROM AUTHOR]

The article reports on the use of decision tools to help improve the personalized care in treatment of cardiovascular disease. Topics mentioned include the efficiency of personalized care, the importance of the Dual Antiplatelet Therapy Study in the dual-antiplatelet therapy's duration, and the importance of patient-physician dialogue in personalized medicine.

Anthropogenic threats to natural systems can be exacerbated due to connectivity between marine, freshwater, and terrestrial ecosystems, complicating the already daunting task of governance across the land-sea interface. Globalization, including new access to markets, can change social-ecological, land-sea linkages via livelihood responses and adaptations by local people. As a first step in understanding these trans-ecosystem effects, we examined exit and entry decisions of artisanal fishers and smallholder farmers on the rapidly globalizing Caribbean coast of Nicaragua. We found that exit and entry decisions demonstrated clear temporal and spatial patterns and that these decisions differed by livelihood. In addition to household characteristics, livelihood exit and entry decisions were strongly affected by new access to regional and global markets. The natural resource implications of these livelihood decisions are potentially profound as they provide novel linkages and spatially-explicit feedbacks between terrestrial and marine ecosystems. Our findings support the need for more scientific inquiry in understanding trans-ecosystem tradeoffs due to linked-livelihood transitions as well as the need for a trans-ecosystem approach to natural resource management and development policy in rapidly changing coastal regions. [ABSTRACT FROM AUTHOR]

Medical devices increasingly depend on software. While this expands the ability of devices to perform key therapeutic and diagnostic functions, reliance on software inevitably causes exposure to hazards of security vulnerabilities. This article uses a recent high-profile case example to outline a proactive approach to security awareness that incorporates a scientific, risk-based analysis of security concerns that supports ongoing discussions with patients about their medical devices. [ABSTRACT FROM AUTHOR]

Few studies have examined rates and causes of short-term readmissions among adults across age and insurance types. We compared rates, characteristics, and costs of 30-day readmission after all-cause hospitalizations across insurance types in the US. We retrospectively evaluated alive patients ≥18 years old, discharged for any cause, 1/1/13-11/31/13, 2006 non-federal hospitals in 21 states in the Nationwide Readmissions Database. The primary stratification variable of interest was primary insurance. Comorbid conditions were assessed based on Elixhauser comorbidities, as defined by administrative billing codes. Additional measures included diagnoses for index hospitalizations leading to rehospitalization. Hierarchical multivariable logistic regression models, with hospital site as a random effect, were used to calculate the adjusted odds of 30-day readmissions by age group and insurance categories. Cost and discharge estimates were weighted per NRD procedures to reflect a nationally representative sample. Diagnoses for index hospitalizations leading to rehospitalization were determined. Among 12,533,551 discharges, 1,818,093 (14.5%) resulted in readmission within 30 days. Medicaid insurance was associated with the highest adjusted odds ratio (AOR) for readmission both in those ≥65 years old (AOR 1.12, 95%CI 1.10–1.14; p <0.001), and 45–64 (AOR 1.67, 95% CI 1.66–1.69; p < 0.001), and Medicare in the 18–44 group (Medicare vs. private insurance: AOR 1.99, 95% CI 1.96–2.01; p <0.001). Discharges for psychiatric or substance abuse disorders, septicemia, and heart failure accounted for the largest numbers of readmissions, with readmission rates of 24.0%, 17.9%, 22.9% respectively. Total costs for readmissions were 50.7 billion USD, highest for Medicare (29.6 billion USD), with non-Medicare costs exceeding 21 billion USD. While Medicare readmissions account for more than half of the total burden of readmissions, costs of non-Medicare readmissions are nonetheless substantial. Medicaid patients have the highest odds of readmission in individuals older than age 44, commonly due to hospitalizations for psychiatric illness and substance abuse disorders. Medicaid patients represent a population at uniquely high risk for readmission. [ABSTRACT FROM AUTHOR]

Cardiovascular disease (CVD) is the leading cause of death worldwide. Despite medical advances, patients with CVD experience high morbidity and mortality rates, affecting their quality of life and death. Among CVD conditions, palliative care has been studied mostly in patients with heart failure, where palliative care interventions have been associated with improvements in patient-centered outcomes, including quality of life, end-of-life care, and health care use. Although palliative care is now incorporated into the American Heart Association/American College of Cardiology/Heart Failure Society of America guidelines for heart failure, the role of palliative care for non-heart failure CVD remains uncertain. Across all causes of CVD, palliative care can play an important role in all domains of CVD care from initial diagnosis to terminal care. In addition to general cardiovascular palliative care practices applicable to all areas, disease-specific palliative care needs may warrant individualized palliative care models. In this review, we discuss the role of cardiovascular palliative care for ischemic heart disease, valvular disease, arrhythmias, peripheral artery disease, and adult congenital heart disease. Although there are multiple barriers to cardiovascular palliative care, we recommend a framework for studying and developing cardiovascular palliative care models to improve patient-centered goal-concordant care for this underserved patient population. [ABSTRACT FROM AUTHOR]

The proliferation of data collected in routine clinical care and advances in quantitative analytic methods have created immediate opportunities to individualize cardiovascular care through the use of decision tools. Such tools rely on the analysis of simple variables collected from medical records or direct patient observation to identify those with the most to gain or lose from treatment, as determined by the collective experiences of similar patients treated previously. However, a number of obstacles limit the creation and use of decision tools. Here, we review the theoretical foundation of decision tools, highlight examples of successful efforts to model heterogeneity in treatment benefit, and suggest future goals to better use quantitative methods to personalize care. [ABSTRACT FROM AUTHOR]

Objectives To evaluate the incidence and characteristics of nursing home (NH) use after implantable cardioverter-defibrillator (ICD) implantation. Design Cohort study. Setting Medicare beneficiaries in the National Cardiovascular Data Registry- ICD Registry. Participants Individuals aged 65 and older receiving ICDs between January 1, 2006, and March 31, 2010 (N = 192,483). Measurements Proportion of ICD recipients discharged to NHs directly after device placement, cumulative incidence of long-term NH admission, and factors associated with immediate discharge to a NH and time to long-term NH admission. Results Over 4 years, 40.6% of the cohort died, and 35,939 (18.7%) experienced at least one NH admission, including 4.0% directly discharged to a NH after ICD implantation and 2.8% admitted to long-term NH care during follow-up. The cumulative incidence of long-term NH admission, accounting for the competing risk of death, was 1.7% at 1 year, 3.8% at 3 years, and 4.6% at 4 years; 20.1% of individuals admitted to a NH died there. Factors most strongly associated with direct NH discharge and time to long-term NH care were older age (adjusted odds ratio (AOR) = 2.09, 95% confidence interval ( CI) = 2.01-2.17 per 10-year increment; adjusted hazard ratio (AHR) = 1.88, 95% CI = 1.80-1.97, respectively), dementia (AOR = 2.60, 95% CI = 2.25-3.01; AHR = 2.50, 95% CI = 2.14-2.93, respectively), and Medicare Part A claim for NH stay in prior 6 months (AOR = 3.96, 95% CI = 3.70-4.25; AHR = 2.88, 95% CI = 2.65-3.14, respectively). Conclusion Nearly one in five individuals are admitted to NHs over a median of 1.6 years of follow-up after ICD implantation. Understanding these outcomes may help inform the clinical care of these individuals. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

An introduction is presented in which the authors discuss various reports within the journal on topics including improvements to the safety and effectiveness of medical devices in America, the U.S. Food and Drug Administration, and the identification of device malfunction involving gastric bands.

Agent-based models (ABMs) have been widely used to study socioecological systems. They are useful for studying such systems because of their ability to incorporate micro-level behaviors among interacting agents, and to understand emergent phenomena due to these interactions. However, ABMs are inherently stochastic and require proper handling of uncertainty. We propose a simulation framework based on quantitative uncertainty and sensitivity analyses to build parsimonious ABMs that serve two purposes: exploration of the outcome space to simulate low-probability but high-consequence events that may have significant policy implications, and explanation of model behavior to describe the system with higher accuracy. The proposed framework is applied to the problem of modeling farmland conservation resulting in land use change. We employ output variance decomposition based on quasi-random sampling of the input space and perform three computational experiments. First, we perform uncertainty analysis to improve model legitimacy, where the distribution of results informs us about the expected value that can be validated against independent data, and provides information on the variance around this mean as well as the extreme results. In our last two computational experiments, we employ sensitivity analysis to produce two simpler versions of the ABM. First, input space is reduced only to inputs that produced the variance of the initial ABM, resulting in a model with output distribution similar to the initial model. Second, we refine the value of the most influential input, producing a model that maintains the mean of the output of initial ABM but with less spread. These simplifications can be used to 1) efficiently explore model outcomes, including outliers that may be important considerations in the design of robust policies, and 2) conduct explanatory analysis that exposes the smallest number of inputs influencing the steady state of the modeled system. [ABSTRACT FROM AUTHOR]

IMPORTANCE The US Food and Drug Administration (FDA) evaluates high-risk medical devices such as cardiac implantable electronic devices (CIEDs), including pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy devices, via the premarket approval (PMA) process, during which manufacturers submit clinical data demonstrating safety and effectiveness. Subsequent changes to approved high-risk devices are implemented via "supplements," which may not require additional clinical testing. OBJECTIVE To characterize the prevalence and characteristics of changes to CIEDs made through the PMA supplement process. DESIGN Using the FDA's PMA database, we reviewed all CIEDs approved as original PMAs or supplements from 1979 through 2012. For each supplement, we collected the date approved, type of supplement (panel-track, 180-day, real-time, special, and 30-day notice), and the nature of the changes. We calculated the number of supplements approved per PMA and analyzed trends relating to different supplement regulatory categories over time. For supplements approved via the 180-day regulatory pathway, which often involve significant design changes, from 2010-2012, we identified how often additional clinical data were collected. RESULTS From 1979-2012, the FDA approved 77 original and 5829 supplement PMA applications for CIEDs, with a median of 50 supplements per original PMA (interquartile range [IQR], 23-87). Excluding manufacturing changes that do not alter device design, the number of supplements approved each year was stable around a mean (SD) of 2.6 (0.9) supplements per PMA per year. Premarket approvals remained active via successive supplements over a median period of 15 years (IQR, 8-20), and 79% of the 77 original PMAs approved during our study period were the subject of at least 1 supplement in 2012. Thirty-seven percent of approved supplements involved a change to the device's design. Among 180-day supplements approved from 2010-2012, 23% (15/64) included new clinical data to support safety and effectiveness. CONCLUSIONS AND RELEVANCE Many CIED models currently used by clinicians were approved via the PMA supplement process, not as original PMAs. Most new device models are deemed safe and effective without requiring new clinical data, reinforcing the importance of rigorous postapproval surveillance of these devices. [ABSTRACT FROM AUTHOR]

: Daniel Kramer and colleagues compare strategies for postmarket surveillance of medical devices and discuss ways to improve these systems. Please see later in the article for the Editors' Summary [ABSTRACT FROM AUTHOR]

Cardiac resynchronization therapy ( CRT) is a device-based treatment available to select individuals with systolic heart failure ( HF), a large proportion of whom are aged 65 and older. As the field of CRT advances, together with shifting demographics and expanded indications for implantation, there is a need for practitioners caring for older adults to understand what is and is not known about the use of CRT specifically in this population. Clinical trials demonstrating benefits for severe and mild HF have uncertain generalizability to older adults. Other studies demonstrate that device-related complications may be more common with CRT than with simpler devices and more common in older adults. CRT clinical trials also may not adequately capture outcomes and concerns specific to older adults, including quality of life and end-of-life care experiences. Informed decision-making by clinicians, policy-makers, and patients will require greater understanding of the use and outcomes of CRT in older persons. [ABSTRACT FROM AUTHOR]

Background: Medical devices increasingly depend on computing functions such as wireless communication and Internet connectivity for software-based control of therapies and network-based transmission of patients' stored medical information. These computing capabilities introduce security and privacy risks, yet little is known about the prevalence of such risks within the clinical setting. Methods: We used three comprehensive, publicly available databases maintained by the Food and Drug Administration (FDA) to evaluate recalls and adverse events related to security and privacy risks of medical devices. Results: Review of weekly enforcement reports identified 1,845 recalls; 605 (32.8%) of these included computers, 35 (1.9%) stored patient data, and 31 (1.7%) were capable of wireless communication. Searches of databases specific to recalls and adverse events identified only one event with a specific connection to security or privacy. Software-related recalls were relatively common, and most (81.8%) mentioned the possibility of upgrades, though only half of these provided specific instructions for the update mechanism. Conclusions: Our review of recalls and adverse events from federal government databases reveals sharp inconsistencies with databases at individual providers with respect to security and privacy risks. Recalls related to software may increase security risks because of unprotected update and correction mechanisms. To detect signals of security and privacy problems that adversely affect public health, federal postmarket surveillance strategies should rethink how to effectively and efficiently collect data on security and privacy problems in devices that increasingly depend on computing systems susceptible to malware. [ABSTRACT FROM AUTHOR]

Background: Policymakers and regulators in the United States (US) and the European Union (EU) are weighing reforms to their medical device approval and post-market surveillance systems. Data may be available that identify strengths and weakness of the approaches to medical device regulation in these settings. Methods and Findings: We performed a systematic review to find empirical studies evaluating medical device regulation in the US or EU. We searched Medline using two nested categories that included medical devices and glossary terms attributable to the US Food and Drug Administration and the EU, following PRISMA guidelines for systematic reviews. We supplemented this search with a review of the US Government Accountability Office online database for reports on US Food and Drug Administration device regulation, consultations with local experts in the field, manual reference mining of selected articles, and Google searches using the same key terms used in the Medline search. We found studies of premarket evaluation and timing (n = 9), studies of device recalls (n = 8), and surveys of device manufacturers (n = 3). These studies provide evidence of quality problems in pre-market submissions in the US, provide conflicting views of device safety based largely on recall data, and relay perceptions of some industry leaders from self-surveys. Conclusions: Few studies have quantitatively assessed medical device regulation in either the US or EU. Existing studies of US and EU device approval and post-market evaluation performance suggest that policy reforms are necessary for both systems, including improving classification of devices in the US and promoting transparency and post-market oversight in the EU. Assessment of regulatory performance in both settings is limited by lack of data on post-approval safety outcomes. Changes to these device approval and post-marketing systems must be accompanied by ongoing research to ensure that there is better assessment of what works in either setting. [ABSTRACT FROM AUTHOR]

The article compares the medical device regulations in the U.S. and the European Union (EU). High-risk device manufacturers in the U.S. are required by the Food and Drug Administration (FDA) to demonstrate safety and effectiveness before they can market their products. In Europe, patients have access to high-risk medical devices such as replacement joints and coronary stents. Criticisms against the EU system for conflicts of interest in its evaluation process are discussed.

A device interrogation for a 32-year-old woman with arrhythmogenic right ventricular cardiomyopathy and an implantable cardioverter-defibrillator capable of monitoring intrathoracic impedance demonstrated a dramatic increase in her OptiVol Fluid index levels in the absence of clinical heart failure. The timing of her intrathoracic impedance changes correlated with plasma volume changes during an uneventful pregnancy without cardiovascular complications. The strengths and limitations of intrathoracic impedance are described in the context of the physiology of pregnancy. [ABSTRACT FROM AUTHOR]

While surgical epicardial lead placement is performed in a subset of cardiac resynchronization therapy patients, data comparing survival following surgical versus transvenous lead placement are limited. We hypothesized that surgical procedures would be associated with increased mortality risk. Long-term event-free survival was assessed for 480 consecutive patients undergoing surgical (48) or percutaneous (432) left ventricle (LV) lead placement at our institution from January 2000 to September 2008. Baseline clinical and demographic characteristics were similar between groups. While there was no statistically significant difference in overall event-free survival (P = 0.13), when analysis was restricted to surgical patients with isolated surgical lead placement (n = 28), event-free survival was significantly lower in surgical patients (P = 0.015). There appeared to be an early risk (first approximately 3 months postimplantation) with surgical lead placement, primarily in LV lead-only patients. Event rates were significantly higher in LV lead-only surgical patients than in transvenous patients in the first 3 months (P = 0.006). In proportional hazards analysis comparing isolated surgical LV lead placement to transvenous lead placement, adjusted hazard ratios were 1.8 ([1.1,2.7] P = 0.02) and 1.3 ([1.0,1.7] P = 0.07) for the first 3 months and for the full duration of follow-up, respectively. Isolated surgical LV lead placement appears to carry a small but significant upfront mortality cost, with risk extending beyond the immediate postoperative period. Long-term survival is similar, suggesting those surviving beyond this period of early risk derive the same benefit as coronary sinus lead recipients. Further work is needed to identify risk factors associated with early mortality following surgical lead placement. (PACE 2011; 34:490-500) [ABSTRACT FROM AUTHOR]

Protected areas are a common strategy to conserve biodiversity, ecological function, and ecosystem services. Through land market dynamics, however, protected area establishment can induce effects inimical to conservation goals. We examined the factors explaining land conversion within 2 km buffers of protected areas in Michigan, United States. We employed multilevel logistic models, with and without autocovariates, utilizing a multimodel inference paradigm. The most parsimonious models indicated that parcels with more developed, forested, and protected land in their vicinity, with well-drained soils, at lower elevations, nearer roads and urban areas, in areas of greater population, and originally in agriculture are more likely to be developed. There is weak support for attributes of protected areas such as size, access, ownership, and protection mechanism affecting nearby land conversion. Our results stress the importance of a well-designed system of protected areas and broad evaluations of the impacts of existing and future threats. [ABSTRACT FROM AUTHOR]

The author discusses the effectiveness of cardiac implantable electrical devices. He discusses the comparison of implantable cardioverter defibrillator (ICD) or cardiac resynchronisation therapy (CRT) with pacemaker (CRT-P) or defibrillator (CRT-D) function. He also states the network meta-analytical approach which uses direct treatment comparisons such as medical therapy with CRT.

The utility of traditional bio-economic harvest models suffers from their dependence on two commonly used approaches. First, optimization is often assumed for harvester behavior despite system complexity and the often neglected costs associated with information gathering and deliberation. Second, ecosystem interactions are infrequently modeled despite a growing awareness that these interactions are important. This paper develops a simulation model to examine the consequences of harvesting at two trophic levels in a coral-reef food web. The model assumes adaptive rather than optimizing behavior among fishermen. The consequences of changing economic, biological, and social parameters are examined using resilience as an evaluative framework. Three general conclusions are reached. First, the simulated ecosystem is sensitive to small changes in economic, biological, and social parameters. Second, threshold effects are common. Third, as compared to results typical of traditional single-species optimization models, some results are counter-intuitive. Benefits of this approach are that the model affirms and adds to the results of traditional bio-economic harvest models, is empirically operational, and provides a richer selection of policy alternatives. Finally, the analysis of trade-offs in terms of resilience provides a useful evaluative framework for multiple-species harvest models. [ABSTRACT FROM AUTHOR]

The degree to which increased right-sided heart pressures influence outcome in cardiac resynchronization therapy (CRT) is unclear. High right ventricular (RV) pressures may contribute to septal malpositioning, thus hindering effective resynchronization. We hypothesized that patients with high RV systolic pressures before CRT implantation would have poorer outcome. We evaluated echocardiograms, electrocardiograms, and clinical records from 75 consecutive patients with CRT. RV systolic pressure was calculated from the peak tricuspid regurgitant, time–velocity profile. The primary end point was a composite of mortality, cardiac transplantation, or need for a left ventricular assist device. Events were evaluated by Kaplan-Meier curves and Cox proportional hazard ratios. Patients grouped by RV systolic pressure divided at the median of 35 mm Hg were similar except for more renal insufficiency and RV dysfunction when RV systolic pressure was >35 mm Hg. Univariate analysis identified RV systolic pressure >35 mm Hg (hazard ratio [HR] 3.32), diabetes (HR 2.45), renal insufficiency (HR 3.52), atrial fibrillation (HR 3.07), use of nonamiodarone antiarrhythmic medications (HR 2.86), atrial pacing (HR 2.57), and prolonged PR interval (HR 1.009) as associated with poorer outcome. Normal sinus rhythm at implantation (HR 0.34), baseline left bundle branch block (HR 0.44), and β-blocker use (HR 0.47) were associated with improved outcome. In a multivariable model, high RV systolic pressure (HR 3.71, 95% confidence interval 1.31 to 10.4), renal insufficiency (HR 3.18, 95% confidence interval 1.29 to 7.86), and atrial fibrillation (HR 4.22, 95% confidence interval 1.54 to 11.6) remained significant. In conclusion, despite resynchronization, patients with high RV pressures have significantly decreased survival after adjusting for significant contributing influences. [Copyright &y& Elsevier]

Background: Conventional superior access for cardiac implantable electronic devices (CIEDs) is not always possible and femoral CIEDs (F‐CIED) are an alternative option when leadless systems are not suitable. The long‐term outcomes and extraction experiences with F‐CIEDs, in particular complex F‐CIED (ICD/CRT devices), remain poorly understood. Methods: Patients referred for F‐CIEDs implantation between 2002 and 2019 at two tertiary centers were included. Early complications were defined as ≤30 days following implant and late complications >30 days. Results: Thirty‐one patients (66% male; age 56 ± 20 years; 35% [11] patients with congenital heart disease) were implanted with F‐CIEDs (10 ICD/CRT and 21 pacemakers). Early complications were observed in 6.5% of patients: two lead displacements. Late complications at 6.8 ± 4.4 years occurred in 29.0% of patients. This was higher with complex F‐CIED compared to simple F‐CIED (60.0% vs. 14.3%, p =.02). Late complications were predominantly generator site related (n = 8, 25.8%) including seven infections/erosions and one generator migration. Eight femoral generators and 14 leads (median duration in situ seven [range 6–11] years) were extracted without complication. Conclusions: Procedural success with F‐CIEDs is high with clinically acceptable early complication rates. There is a notable risk of late complications, particularly involving the generator site of complex devices following repeat femoral procedures. Extraction of chronic F‐CIED in experienced centers is feasible and safe. [ABSTRACT FROM AUTHOR]

The authors reflect on the medical device excise tax, a 2.3 percent tax on domestic sales of medical devices in the U.S. The uncertainty facing this source of funding for the Affordable Care Act (ACA) is highlighted. Where the excise tax came from and why it is in danger of repeal are explored. What the repeal would mean for the ACA is discussed.

The article discusses the U.S. Food and Drug Administration (FDA) Safety and Innovation Act (FDASIA). The Act extends user fees to generic drugs manufacturers in order to offer greater funding for FDA's generic-drug reviewers. It ensures that FDA will receive the user-fee funding that it needs to help promote review efficiency. However, the author argues that the ACT failed to promote more robust postmarketing systems to validate the effectiveness and safety of marketed products.

The "right to repair" movement highlights opportunities to reduce health care costs and promote public health resilience through increased competition in the way in which medical devices are serviced and updated over their lifespan. We review legislative and legal facets of third-party repair of medical devices, and conclude with specific recommendations to help this market function more efficiently to the benefit of patients and health care systems. [ABSTRACT FROM AUTHOR]

The article discusses the need for the development of a new approach to the replacement of implantable cardioverter defibrillators (ICD). It says that patients who are presented for possible ICD replacement needs to be thoroughly reevaluated. According to the author, medical professionals also need to assess patients' experiences since these could affect their views on replacement.

The article discusses the advisory sent in August 2017 by the U.S. Food and Drug Administration (FDA) regarding the possible hacking of cardiac pacemakers and implantable cardioverter-defibrillators. It mentions the potential interference with the device, its programming, or information sent wirelessly to care providers, the devices specifically made by St. Jude Medical Inc., and the necessary steps to take now and in the future.

Policy PointsMillions of life‐sustaining implantable devices collect and relay massive amounts of digital health data, increasingly by using user‐downloaded smartphone applications to facilitate data relay to clinicians via manufacturer servers.Our analysis of health privacy laws indicates that most US patients may have little access to their own digital health data in the United States under the Health Insurance Portability and Accountability Act Privacy Rule, whereas the EU General Data Protection Regulation and the California Consumer Privacy Act grant greater access to device‐collected data.Our normative analysis argues for consistently granting patients access to the raw data collected by their implantable devices. Context: Millions of life‐sustaining implantable devices collect and relay massive amounts of digital health data, increasingly by using user‐downloaded smartphone applications to facilitate data relay to clinicians via manufacturer servers. Whether patients have either legal or normative claims to data collected by these devices, particularly in the raw, granular format beyond that summarized in their medical records, remains incompletely explored. Methods: Using pacemakers and implantable cardioverter‐defibrillators (ICDs) as a clinical model, we outline the clinical ecosystem of data collection, relay, retrieval, and documentation. We consider the legal implications of US and European privacy regulations for patient access to either summary or raw device data. Lastly, we evaluate ethical arguments for or against providing patients access to data beyond the summaries presented in medical records. Findings: Our analysis of applicable health privacy laws indicates that US patients may have little access to their raw data collected and held by device manufacturers in the United States under the Health Insurance Portability and Accountability Act Privacy Rule, whereas the EU General Data Protection Regulation (GDPR) grants greater access to device‐collected data when the processing of personal data falls under the GDPR's territorial scope. The California Consumer Privacy Act, the "little sister" of the GDPR, also grants greater rights to California residents. By contrast, our normative analysis argues for consistently granting patients access to the raw data collected by their implantable devices. Smartphone applications are increasingly involved in the collection, relay, retrieval, and documentation of these data. Therefore, we argue that smartphone user agreements are an emerging but potentially underutilized opportunity for clarifying both legal and ethical claims for device‐derived data. Conclusions: Current health privacy legislation incompletely supports patients' normative claims for access to digital health data. [ABSTRACT FROM AUTHOR]

The article presents the Watchman Left Atrial Appendage Closure System designed as the most intensely studied device for thromboembolic prophylaxis in patients with nonvalvular atrial fibrillation. Topics discussed include a Food and Drug Administration (FDA) advisory committee review of findings from manufacturing, bench and clinical testing of the device and the importance of timely data on real-world experience to complement clinical-trial evidence to understand a technology like Watchman.