Evolving methodology of national tobacco control investment cases.

BACKGROUND: This article describes an investment case methodology for tobacco control that was applied in 36 countries between 2017 and 2022. METHODS: The WHO Framework Convention on Tobacco Control (FCTC) investment cases compared two scenarios: a base case that calculated the tobacco-attributable mortality, morbidity and economic costs with status quo tobacco control, and an intervention scenario that described changes in those same outcomes from fully implementing and enforcing a variety of proven, evidence-based tobacco control policies and interventions. Health consequences included the tobacco-attributable share of mortality and morbidity from 38 diseases. The healthcare expenditures and the socioeconomic costs from the prevalence of those conditions were combined to calculate the total losses due to tobacco. The monetised benefits of improvements in health resulting from tobacco control implementation were compared with costs of expanding tobacco control to assess returns on investment in each country. An institutional and context analysis assessed the political and economic dimensions of tobacco control in each context. RESULTS: We applied a rigorous yet flexible methodology in 36 countries over 5 years. The replicable model and framework may be used to inform development of tobacco control cases in countries worldwide. CONCLUSION: Investment cases constitute a tool that development partners and advocates have demanded in even greater numbers. The economic argument for tobacco control provided by this set of country-contextualised analyses can be a strong tool for policy change.

Equity implications of tobacco taxation: results from WHO FCTC investment cases.

BACKGROUND: Across time, geographies and country income levels, smoking prevalence is highest among people with lower incomes. Smoking causes further impoverishment of those on the lower end of the income spectrum through expenditure on tobacco and greater risk of ill health. METHODS: This paper summarises the results of investment case equity analyses for 19 countries, presenting the effects of increased taxation on smoking prevalence, health and expenditures. We disaggregate the number of people who smoke, smoking-attributable mortality and cigarette expenditures using smoking prevalence data by income quintile. A uniform 30% increase in price was applied across countries. We estimated the effects of the price increase on smoking prevalence, mortality and cigarette expenditures. RESULTS: In all but one country (Bhutan), a one-time 30% increase in price would reduce smoking prevalence by the largest percent among the poorest 20% of the population. All income groups in all countries would spend more on cigarettes with a 30% increase in price. However, the poorest 20% would pay an average of 12% of the additional money spent. CONCLUSIONS: Our results confirm that health benefits from increases in price through taxation are pro-poor. Even in countries where smoking prevalence is higher among wealthier groups, increasing prices can still be pro-poor due to variable responsiveness to higher prices. The costs associated with higher smoking prevalence among the poor, together with often limited access to healthcare services and displaced spending on basic needs, result in health inequality and perpetuate the cycle of poverty.

Advancing progress on tobacco control in low-income and middle-income countries through economic analysis.

BACKGROUND: More than 80% of the world's 1.3 billion tobacco users live in low-income and middle-income countries (LMICs), where progress to address tobacco and its harms has been slow. The perception that tobacco control detracts from economic priorities has impeded progress. The Secretariat of the WHO Framework Convention on Tobacco Control (FCTC) is leading the FCTC 2030 project, which includes technical assistance to LMICs to analyse the economic costs of tobacco use and the benefits of tobacco control. METHODS: The Secretariat of the WHO FCTC, United Nations Development Programme and WHO supported 21 LMICs between 2017 and 2022 to complete national investment cases to guide country implementation of the WHO FCTC, with analytical support provided by RTI International. These country-level cases combine customised estimates of tobacco's economic impact with qualitative analysis of socio-political factors influencing tobacco control. This paper overviews the approach, observed tobacco control advancements and learnings from 21 countries: Armenia, Cabo Verde, Cambodia, Chad, Colombia, Costa Rica, El Salvador, Eswatini, Georgia, Ghana, Jordan, Laos, Madagascar, Myanmar, Nepal, Samoa, Sierra Leone, Sri Lanka, Suriname, Tunisia and Zambia. RESULTS: Tobacco control advancements in line with investment case findings and recommendations have been observed in 17 of the 21 countries, and many have improved collaboration and policy coherence between health and economic stakeholders. CONCLUSIONS: Tobacco control must be seen as more than a health concern. Tobacco control leads to economic benefits and contributes to sustainable development. National investment cases can support country ownership and leadership to advance tobacco control.

The case for investment in tobacco control: lessons from four countries in the Americas.

Objective: To synthesize learnings from four national tobacco control investment cases conducted in the Americas (Colombia, Costa Rica, El Salvador, Suriname) under the World Health Organization Framework Convention on Tobacco Control (WHO FCTC) 2030 project, to describe results and how national health authorities have used the cases, and to discuss implications for the role of investment cases in advancing tobacco control. Methods: We draw on findings from four national investment cases that included 1) a cost-of-illness analysis calculating the health and economic burden of tobacco use, 2) a return-on-investment analysis of implementing key tobacco control demand reduction measures, and 3) a subsidiary analysis of one tobacco control topic of national interest (e.g., equity implications of cigarette taxation). Co-authors reported how cases have been used to advance tobacco control. Results: In Colombia, Costa Rica, El Salvador, and Suriname, tobacco use causes social and economic losses equivalent to between 1.0 to 1.8 percent of GDP. Across these countries, implementing WHO FCTC demand reduction measures would save an average of 11 400 lives per year over the next 15 years. Benefits of the measures would far outweigh the costs of implementation and enforcement. Governments are using the cases to advance tobacco control, including to improve tobacco control laws and their enforcement, strengthen tobacco taxation, prioritize tobacco control planning, coordinate a multisectoral response, and engage political leaders. Conclusions: National investment cases can help to strengthen tobacco control in countries, including by increasing public and political support for implementation of the WHO FCTC and by informing effective planning, legislation, coordination and financing.

Financing intersectoral action for health: a systematic review of co-financing models.

BACKGROUND: Addressing the social and other non-biological determinants of health largely depends on policies and programmes implemented outside the health sector. While there is growing evidence on the effectiveness of interventions that tackle these upstream determinants, the health sector does not typically prioritise them. From a health perspective, they may not be cost-effective because their non-health outcomes tend to be ignored. Non-health sectors may, in turn, undervalue interventions with important co-benefits for population health, given their focus on their own sectoral objectives. The societal value of win-win interventions with impacts on multiple development goals may, therefore, be under-valued and under-resourced, as a result of siloed resource allocation mechanisms. Pooling budgets across sectors could ensure the total multi-sectoral value of these interventions is captured, and sectors' shared goals are achieved more efficiently. Under such a co-financing approach, the cost of interventions with multi-sectoral outcomes would be shared by benefiting sectors, stimulating mutually beneficial cross-sectoral investments. Leveraging funding in other sectors could off-set flat-lining global development assistance for health and optimise public spending. Although there have been experiments with such cross-sectoral co-financing in several settings, there has been limited analysis to examine these models, their performance and their institutional feasibility. AIM: This study aimed to identify and characterise cross-sectoral co-financing models, their operational modalities, effectiveness, and institutional enablers and barriers. METHODS: We conducted a systematic review of peer-reviewed and grey literature, following PRISMA guidelines. Studies were included if data was provided on interventions funded across two or more sectors, or multiple budgets. Extracted data were categorised and qualitatively coded. RESULTS: Of 2751 publications screened, 81 cases of co-financing were identified. Most were from high-income countries (93%), but six innovative models were found in Uganda, Brazil, El Salvador, Mozambique, Zambia, and Kenya that also included non-public and international payers. The highest number of cases involved the health (93%), social care (64%) and education (22%) sectors. Co-financing models were most often implemented with the intention of integrating services across sectors for defined target populations, although models were also found aimed at health promotion activities outside the health sector and cross-sectoral financial rewards. Interventions were either implemented and governed by a single sector or delivered in an integrated manner with cross-sectoral accountability. Resource constraints and political relevance emerged as key enablers of co-financing, while lack of clarity around the roles of different sectoral players and the objectives of the pooling were found to be barriers to success. Although rigorous impact or economic evaluations were scarce, positive process measures were frequently reported with some evidence suggesting co-financing contributed to improved outcomes. CONCLUSION: Co-financing remains in an exploratory phase, with diverse models having been implemented across sectors and settings. By incentivising intersectoral action on structural inequities and barriers to health interventions, such a novel financing mechanism could contribute to more effective engagement of non-health sectors; to efficiency gains in the financing of universal health coverage; and to simultaneously achieving health and other well-being related sustainable development goals.

Peri-Implant Fracture Following Prior Fixation of Femoral Neck Fracture Using the Femoral Neck System: A Case Report.

Introduction: Peri-implant fractures (PIF) reported after cannulated screw and dynamic hip screw fixation historically occur distal to the implant within the subtrochanteric region secondary to the development of a stress riser. Newer implant designs for femoral neck fractures have attempted to combine the benefits of minimally invasive techniques without forgoing rigid angular stability but bring new potential complications. Case Report: We present a case of an intertrochanteric PIF in the setting of a non-displaced femoral neck fracture treated with the DePuy Synthes Femoral Neck System (FNS). Conclusion: We present this case of a unique PIF pattern with the hope of identifying a potential complication associated with the novel FNS. Furthermore, we present a successful treatment option avoiding the need for conversion to hemiarthroplasty.

The reported impact of non-communicable disease investment cases in 13 countries.

Non-communicable diseases (NCDs) are a leading health and development challenge worldwide. Since 2015, WHO and the United Nations Development Programme have provided support to governments to develop national NCD investment cases to describe the socioeconomic dimensions of NCDs. To assess the impact of the investment cases, semistructured interviews and a structured process for gathering written feedback were conducted between July and October 2022 with key informants in 13 countries who had developed a national NCD investment case between 2015 and 2020. Investment cases describe: (1) the social and economic costs of NCDs, including their distribution and projections over time; (2) priority areas for scaled up action; (3) the cost and returns from investing in WHO-recommended measures to prevent and manage NCDs; and (4) the political dimensions of NCD responses. While no country had implemented all the recommendations set out in their investment case reports, actions and policy changes attributable to the investment cases were identified, across (1) governance; (2) financing; and (3) health service access and delivery. The pathways of these changes included: (1) stronger collaboration across government ministries and partners; (2) advocacy for NCD prevention and control; (3) grounding efforts in nationally owned data and evidence; (4) developing mutually embraced 'language' across health and finance; and (5) elevating the priority accorded to NCDs, by framing action as an investment rather than a cost. The assessment also identified barriers to progress on the investment case implementation, including the influence of some private sector entities on sectors other than health, the impact of the COVID-19 pandemic, and changes in senior political and technical government officials. The results suggest that national NCD investment cases can significantly contribute to catalysing the prevention and control of NCDs through strengthening governance, financing, and health service access and delivery.

Sleep-disordered breathing in heart failure: identifying and treating an important but often unrecognized comorbidity in heart failure patients.

Sleep-disordered breathing (SDB) is the most common comorbidity in patients with heart failure (HF) and has a significant impact on quality of life, morbidity, and mortality. A number of therapeutic options have become available in recent years that can improve quality of life and potentially the outcomes of HF patients with SDB. Unfortunately, SDB is not part of the routine evaluation and management of HF, so it remains untreated in most HF patients. Although recognition of the role of SDB in HF is increasing, clinical guidelines for the management of SDB in HF patients continue to be absent. This article provides an overview of SDB in HF and proposes a clinical care pathway to help clinicians to better recognize and treat SDB in their HF patients.

Threshold crossing of device-based intrathoracic impedance trends identifies relatively increased mortality risk.

AIMS: Threshold crossings of impedance trends detected by implanted devices have been associated with clinically relevant heart failure events, but long-term prognosis of such events has not been demonstrated. The aim of this study is to examine the relationship between alterations in intrathoracic impedance and mortality risk in patients with implantable devices. METHODS AND RESULTS: We reviewed remote monitoring data in the de-identified Medtronic CareLink(®) Discovery Link that captured intrathoracic impedance trends for >6 months. The initial 6 months of the cardiac and impedance trends were used as the observation period to create the patient groups and cross-referenced with the Social Security Death Index for mortality data. In our study cohort of 21 217 patients, 36% experienced impedance threshold crossing within the initial 6 months of monitoring (defined as the 'early threshold crossing' group). Patients with early threshold crossings demonstrated an increased risk of age- and gender-adjusted all-cause mortality [hazard ratio (HR) 2.15, 95% confidence interval (CI) 1.95-2.38, P< 0.0001]. Increased mortality risk remained significant when analysed in subgroups of patients without defibrillator shock (HR 2.10, 95% CI 1.90-2.34, P< 0.0001, n= 1621) or within those patients without device-detectable atrial fibrillation (AF) during the initial 6 months of monitoring (HR 2.09, 95% CI 1.86-2.34, P< 0.0001, n= 17 235). Both the number and the duration of early threshold crossings of impedance trends detectable by implanted devices were associated with increased mortality risk. Furthermore, the improvement of altered impedance trends portends more favourable prognosis. CONCLUSIONS: Threshold crossing of impedance trends detectable by implanted devices is associated with relatively increased mortality risk even after adjusted for demographic, device-detected AF, or defibrillator shocks.

Competing Frames in Global Health Governance: An Analysis of Stakeholder Influence on the Political Declaration on Non-communicable Diseases.

BACKGROUND: Non-communicable diseases (NCDs) are increasingly recognized as a significant threat to health and development globally, and United Nations (UN) Member States adopted the Political Declaration of the Third High-level Meeting (HLM) on the prevention and control of NCDs in 2018. The negotiation process for the Declaration included consultations with Member States, intergovernmental organizations (IGOs), and non-state actors such as non-governmental organizations (NGOs) and the private sector. With NCD responses facing charges of inadequacy, it is important to scrutinize the governance process behind relevant high-level global decisions and commitments. METHODS: Through a review of 159 documents submitted by stakeholders during the negotiation process, we outline a typology of policy positions advocated by various stakeholders in the development of the Declaration. We document changes in text from the draft to the final version of the Declaration to analyse the extent to which various positions and their proponents were influential. RESULTS: NGOs and low- and middle-income countries (LMICs) generally pursued 'stricter' governance of NCD risk factors including stronger regulation of unhealthy products and improved management of conflicts of interest that arise when health-harming industries are involved in health policy-making. The private sector and high-income countries generally opposed greater restrictions on commercial factors. The pattern of changes between the draft and final Declaration indicate that advocated positions tended to be included in the Declaration if there was no clear opponent, whereas opposed positions were either not included or included with ambiguous language. CONCLUSION: Many cost-effective policy options to address NCDs, such as taxation of health-harming products, were opposed by high-income countries and the private sector and not well-represented in the Declaration. To ensure robust political commitments and action on NCDs, multi-stakeholder governance for NCDs must consider imbalances in power and influence amongst constituents as well as biases and conflicts in positioning.

Improved algorithm to detect fluid accumulation via intrathoracic impedance monitoring in heart failure patients with implantable devices.

BACKGROUND: Intrathoracic impedance fluid monitoring has been shown to predict worsening congestive heart failure (CHF) in patients with implantable devices. We developed and externally validated a modified algorithm to identify worsening heart failure (HF) by using intrathoracic impedance. METHODS AND RESULTS: The modified algorithm was developed by using published data from 81 CHF subjects averaging 259 days of follow-up. Device-measured daily impedance was input to both the existing and the modified intrathoracic impedance fluid monitoring algorithms to determine a reference impedance and a fluid index (FI). Separate validation sets included 326 cardiac resynchronization therapy device (CRT-D) patients with an average 333 days of follow-up (group 1) and 104 CRT-D/implantable cardioverter/defibrillator (ICD) patients followed for an average of 520 days (group 2). Clinicians and patients in group 2 were blinded to impedance and FI data. HF events included adjudicated HF hospitalizations or emergency room visits. Sensitivity was defined as the percentage of HF events preceded by FI exceeding the predefined threshold (60 Ω-d) within the last 2 weeks. Unexplained detections were FI threshold crossing events not followed by a HF event within 2 weeks. The modified algorithm significantly decreased unexplained detections by 30% (P = .01; GEE) in the development set, 30% (P < .001) in the group 1 validation set, and 43% (P < .001) in group 2. Sensitivity did not change significantly in any group. Simulated monthly review of FI threshold crossings identified subjects at significantly greater risk of worsening HF within the next 30 days. CONCLUSIONS: A modified intrathoracic impedance based fluid detection algorithm lowered the number of unexplained FI threshold crossings and identified patients at significantly increased immediate risk of worsening HF.

Uncovering interim clinical events at the time of clinical encounter by reviewing intrathoracic impedance threshold crossings.

BACKGROUND: Acute decreases in intrathoracic impedance monitored by implanted devices have been shown to precede heart failure exacerbations, although there is still debate regarding its clinical utility in predicting and preventing future events. However, the usefulness of such information to direct patient encounter and enhance patient recall of relevant preceding clinical events at the point of care has not been carefully examined. METHODS AND RESULTS: In this multicenter study, we interviewed 326 patients with heart failure who received an implanted device with intrathoracic impedance-monitoring capabilities both before and after device information was reviewed. We compared the self-reported clinically relevant events (including heart failure hospitalizations, signs and symptoms of worsening heart failure, changes in diuretic therapy, or other fluid-related events) obtained before and after device interrogation, and then examined the relationship between such events with impedance trends documented by the devices. Over 333 ± 96 days of device monitoring, 215 of 326 patients experienced 590 intrathoracic impedance fluid index threshold-crossing events at the nominal threshold value (60 Ω-d). Review of device-derived information led to the discovery of 221 (37%) previously unreported clinically relevant events in 138 subjects. This included 60 subjects not previously identified as having had clinically relevant events (or 35% of the 171 subjects who did not report events). CONCLUSIONS: Our data demonstrated that reviewing device-derived intrathoracic impedance trends at the time of clinical encounter may help uncover self-reporting of potential clinically relevant events.

A critical link between heart failure self-care and intrathoracic impedance.

BACKGROUND: Effective self-care is regarded as essential to the management of heart failure (HF). The influence of self-care on HF decompensation, however, is not well understood. Accordingly, we examined the relationship between self-care and fluid accumulation accompanying worsening HF as indexed by decreasing intrathoracic impedance (Z). METHODS: Z data were collected from 58 HF patients with OptiVol enabled devices (Medtronic Inc, Minneapolis, Minnesota). Heart failure self-care was measured with the European Heart Failure Self-care Behaviour Scale. Regression modeling was used to describe the influence of HF self-care on the likelihood of a fluid index (FI) threshold crossing, the number of threshold crossings, and number of days spent above threshold. RESULTS: Patients were elderly (74.98 [SD, 8.12] years), with a mean left ventricular ejection fraction of 26.21% (SD, 9.77%), and 63.7% had class New York Heart Association III HF. Patients were followed up for 317 (SD, 96) days; 65.5% had FI threshold crossings (mean 1.45 [SD, 1.56] crossings), spending an average of 33.8 (SD, 42.4) days above FI threshold. Controlling for age, sex, left ventricular ejection fraction, functional class, and duration of follow-up, each additional point on the European Heart Failure Self-care Behaviour Scale was associated with an increase in the odds of having had an FI threshold crossing (adjusted odds ratio, 1.201; 95% confidence interval, 1.013-1.424; P<.05) and more days spent above FI threshold (incidence rate ratio, 1.051; 95% confidence interval, 1.002-1.102; P<.05). CONCLUSION: Intrathoracic impedance measurements obtained from implantable devices provide important information regarding the influence of self-care on fluid accumulation in patients with HF.

Correction: The investment case as a mechanism for addressing the NCD burden: Evaluating the NCD institutional context in Jamaica, and the return on investment of select interventions.

[This corrects the article DOI: 10.1371/journal.pone.0223412.].

Changes in intrathoracic impedance are associated with subsequent risk of hospitalizations for acute decompensated heart failure: clinical utility of implanted device monitoring without a patient alert.

BACKGROUND: Acute decreases in intrathoracic impedance monitoring have been shown to precede heart failure hospitalization in a limited population of heart failure patients. We evaluated the relationship between changes in intrathoracic impedance with hospitalizations associated with acute decompensated heart failure (ADHF) in patients with cardiac resynchronization therapy plus defibrillator (CRT-D) devices. METHODS AND RESULTS: The study enrolled 326 heart failure patients who had received CRT-D with impedance-monitoring capabilities (InSync Sentry, Medtronic). The date and duration of ADHF hospitalizations were retrospectively identified before device interrogation to obtain device diagnostic information. During 333 +/- 96 days of device monitoring, 228 patients experienced 540 intrathoracic impedance fluid index threshold crossings events (TCE) at the nominal threshold value (60 Omega. days). During the initial 4-month evaluation period, 17 subjects experienced 22 ADHF hospitalizations. In the subsequent monitoring period (206 +/- 95 days), 18 patients experienced 24 hospitalizations. The occurrence of TCEs during the monitoring period was independently correlated with the subsequent rate of ADHF hospitalization such that each TCE event during the risk stratification period was associated with a 35% increased risk for ADHF hospitalization in the remaining study period (P = .001). Poisson regression indicated that the subgroup of patients with an annual average rate of more than 3 threshold crossings per year during the monitoring period were significantly more likely to be hospitalized for ADHF than those patients with no TCE during the monitoring period (0.76 [0.20-1.325] vs. 0.14 [0.05-0.23] hospitalizations/subject/y [95%CI]; P = .02). Likewise, Kaplan-Meier analysis revealed that subsets of patients with more than 3 TCEs per year or with more than 30 days per year above threshold during the risk stratification period had significantly higher rates of ADHF hospitalization during the post risk stratification period than subjects with no TCE events, respectively. CONCLUSIONS: In this multicenter retrospective cohort study, serial decreases in intrathoracic impedance sufficient to generate a fluid index threshold crossing as well as the net duration that the index remained above threshold during a 4-month monitoring period were associated with subsequent risk of ADHF hospitalization.

The investment case as a mechanism for addressing the NCD burden: Evaluating the NCD institutional context in Jamaica, and the return on investment of select interventions.

Noncommunicable diseases (NCDs) are a broad challenge for decision-makers. NCDs account for seven out of every 10 deaths globally, with 42 percent occurring prematurely in individuals under age 70. Despite their heavy toll, NCDs are underfunded, with only around two percent of global funding dedicated to the disease set. Country governments are responsible for funding targeted actions to reduce the NCD burden, but among other priorities, many have yet to invest in the health-system interventions and policy measures that can reduce the burden. This article examines "investment cases" as a potential mechanism for catalyzing attention to-and funding for-NCDs. In Jamaica, using the UN inter-agency OneHealth Tool, we conducted an economic analysis to estimate the return-on-investment from scaling up strategic clinical interventions, and from implementing or intensifying policy measures that target NCD risk factors. In addition, we conducted an institutional and context (ICA) analysis, interviewing stakeholders across sectors to take stock of promising policy pathways (e.g., areas of general consensus, political appetite and opportunity) as well as challenges to implementation. The economic analysis found that scaling up clinical interventions that target CVD, diabetes, and mental health disorders, and policy measures that target tobacco and alcohol use, would save over 6,600 lives between 2017-2032, and avert JMD 81.3 billion (USD 640 million) in direct and indirect economic costs that result from mortality and morbidity linked to NCDs. The ICA uncovered government economic growth targets and social priorities that would be aided by increased attention to NCDs, and it linked these targets and priorities to the economic analysis.

Reasons for Guideline Nonadherence at Heart Failure Discharge.

Background Cardiology has advanced guideline development and quality measurement. Recognizing the substantial benefits of guideline-directed medical therapy, this study aims to measure and explain apparent deviations in heart failure ( HF ) guideline adherence by clinicians at hospital discharge and describe any impact on readmission rates. Methods and Results The extent of decongestion and prescription of neurohormonal therapy were recorded prospectively for 226 HF discharges, including 132 (58%) from an academic hospital and 94 (42%) from a community hospital. Among all discharges, 25% were discharged with residual congestion (30% academic versus 18% community, P=0.070). Among discharges of patients with HF with reduced ejection fraction, 37% (45% academic versus 18% community, P<0.001) were discharged without ß-blocker therapy or with lower doses than at admission. Moreover, 46% of patients with HF with reduced ejection fraction (48% academic versus 39% community, P=0.390) were discharged without an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker or with lower doses than at admission. Renal dysfunction was the most common reason for discharge with congestion, and hypotension the most common reason for discharge with no or decreased neurohormonal therapy. There was a trend toward higher 90-day readmission rates after discharge with residual congestion. Conclusions Clinicians frequently deviate from guidelines in both academic and community hospitals; however, this deviation may not always indicate poor quality. Application of guidelines recommended for stable populations is increasingly limited for hospitalized patients by hypotension, renal dysfunction, and inotrope use. Patients with renal dysfunction, hypotension, and recent inotrope use merit further study to determine best practices and possibly to adjust quality metrics for HF severity.

Integrating device-based monitoring into clinical practice: insights from a large heart failure clinic.

Heart failure is a difficult and costly disease to manage in part because the symptoms may be protean, the physical findings obscure, and the laboratory assessments unreliable. New implanted physiologic monitors may simplify the care of patients with heart failure, if they can be incorporated into routine clinical practice. Cardiac resynchronization therapy/defibrillators and implantable cardioverter defibrillators with continuous intrathoracic impedance monitoring capabilities (OptiVol fluid status monitoring; Medtronic, Inc., Minneapolis, MN) have recently been introduced and may provide an early warning of thoracic fluid retention. However, patients who have devices with this diagnostic capability must be identified, and the device-based information must be accessed systematically, if it is to be used in the disease management process. Ancillary information, such as the Heart Failure Management Report that is generated from data stored in Medtronic devices, may facilitate recognition of disease mechanisms associated with decompensation. The predictive value of continuous intrathoracic impedance monitoring with an implantable device is still unknown. Thus, therapeutic decisions should be made in conjunction with a clinical assessment. Physicians and other healthcare providers will need to become familiar with these devices so they can appreciate their advantages and limitations.

Remote Monitoring in Heart Failure: the Current State.

OPINION STATEMENT: The treatment of congestive heart failure is an expensive undertaking with much of this cost occurring as a result of hospitalization. It is not surprising that many remote monitoring strategies have been developed to help patients maintain clinical stability by avoiding congestion. Most of these have failed. It seems very unlikely that these failures were the result of any one underlying false assumption but rather from the fact that heart failure is a progressive, deadly disease and that human behavior is hard to modify. One lesson that does stand out from the myriad of methods to detect congestion is that surrogates of congestion, such as weight and impedance, are not reliable or actionable enough to influence outcomes. Too many factors influence these surrogates to successfully and confidently use them to affect HF hospitalization. Surrogates are often attractive because they can be inexpensively measured and followed. They are, however, indirect estimations of congestion, and due to the lack specificity, the time and expense expended affecting the surrogate do not provide enough benefit to warrant its use. We know that high filling pressures cause transudation of fluid into tissues and that pulmonary edema and peripheral edema drive patients to seek medical assistance. Direct measurement of these filling pressures appears to be the sole remote monitoring modality that shows a benefit in altering the course of the disease in these patients. Congestive heart failure is such a serious problem and the consequences of hospitalization so onerous in terms of patient well-being and costs to society that actual hemodynamic monitoring, despite its costs, is beneficial in carefully selected high-risk patients. Those patients who benefit are ones with a prior hospitalization and ongoing New York Heart Association (NYHA) class III symptoms. Patients with NYHA class I and II symptoms do not require hemodynamic monitoring because they largely have normal hemodynamics. Those with NYHA class IV symptoms do not benefit because their hemodynamics are so deranged that they cannot be substantially altered except by mechanical circulatory support or heart transplantation. Finally, hemodynamic monitoring offers substantial hope to those patients with normal ejection fraction (EF) heart failure, a large group for whom medical therapy has largely been a failure. These patients have not benefited from the neurohormonal revolution that improved the lives of their brothers and sisters with reduced ejection fractions. Hemodynamic stabilization improves the condition of both but more so of the normal EF cohort. This is an important observation that will help us design future trials for the 50% of heart failure patients with normal systolic function.