Chronic kidney disease and transvenous cardiac implantable electronic device infection-is there an impact on healthcare utilization, costs, disease progression, and mortality?

AIMS: Cardiac implantable electronic device (CIED) infections are a burden to hospitals and costly for healthcare systems. Chronic kidney disease (CKD) increases the risk of CIED infections, but its differential impact on healthcare utilization, costs, and outcomes is not known. METHODS AND RESULTS: This retrospective analysis used de-identified Medicare Fee-for-Service claims to identify patients implanted with a CIED from July 2016 to December 2020. Outcomes were defined as hospital days and costs within 12 months post-implant, post-infection CKD progression, and mortality. Generalized linear models were used to calculate results by CKD and infection status while controlling for other comorbidities, with differences between cohorts representing the incremental effect associated with CKD. A total of 584 543 patients had a CIED implant, of which 26% had CKD and 1.4% had a device infection. The average total days in hospital for infected patients was 23.5 days with CKD vs. 14.5 days (P < 0.001) without. The average cost of infection was $121 756 with CKD vs. $55 366 without (P < 0.001), leading to an incremental cost associated with CKD of $66 390. Infected patients with CKD were more likely to have septicaemia or severe sepsis than those without CKD (11.0 vs. 4.6%, P < 0.001). After infection, CKD patients were more likely to experience CKD progression (hazard ratio 1.26, P < 0.001) and mortality (hazard ratio 1.89, P < 0.001). CONCLUSION: Cardiac implantable electronic device infection in patients with CKD was associated with more healthcare utilization, higher cost, greater disease progression, and greater mortality compared to patients without CKD.

Cost-effectiveness of an antibacterial envelope for infection prevention in patients undergoing cardiac resynchronization therapy reoperations in Denmark.

AIMS: Use of an absorbable antibacterial envelope during implantation prevents cardiac implantable electronic device infections in patients with a moderate-to-high infection risk. Previous studies demonstrated that an envelope is cost-effective in high-risk patients within German, Italian, and English healthcare systems, but these analyses were based on limited data and may not be generalizable to other healthcare settings. METHODS AND RESULTS: A previously published decision-tree-based cost-effectiveness model was used to compare the costs per quality-adjusted life year (QALY) associated with adjunctive use of an antibacterial envelope for infection prevention compared to standard-of-care intravenous antibiotics. The model was adapted using data from a Danish observational two-centre cohort study that investigated infection-risk patients undergoing cardiac resynchronization therapy (CRT) reoperations with and without an antibacterial envelope (n = 1943). We assumed a cost-effectiveness threshold of €34 125/QALY gained, based on the upper threshold used by the National Institute for Health and Care Excellence (£30 000). An antibacterial envelope was associated with an incremental cost-effectiveness ratio (ICER) of €12 022 per QALY in patients undergoing CRT reoperations, thus indicating that the envelope is cost-effective when compared with standard of care. A separate analysis stratified by device type showed ICERS of €6227 (CRT defibrillator) and €29 177 (CRT pacemaker) per QALY gained. CONCLUSIONS: Cost-effectiveness ratios were favourable for patients undergoing CRT reoperations in the Danish healthcare system, and thus are in line with previous studies. Results from this study can contribute to making the technology available to Danish patients and align preventive efforts in the pacemaker and ICD area.

Exploring spatial feedbacks between adaptation policies and internal migration patterns due to sea-level rise.

Climate change-induced sea-level rise will lead to an increase in internal migration, whose intensity and spatial patterns will depend on the amount of sea-level rise; future socioeconomic development; and adaptation strategies pursued to reduce exposure and vulnerability to sea-level rise. To explore spatial feedbacks between these drivers, we combine sea-level rise projections, socioeconomic projections, and assumptions on adaptation policies in a spatially-explicit model ('CONCLUDE'). Using the Mediterranean region as a case study, we find up to 20 million sea-level rise-related internal migrants by 2100 if no adaptation policies are implemented, with approximately three times higher migration in southern and eastern Mediterranean countries compared to northern Mediterranean countries. We show that adaptation policies can reduce the number of internal migrants by a factor of 1.4 to 9, depending on the type of strategies pursued; the implementation of hard protection measures may even lead to migration towards protected coastlines. Overall, spatial migration patterns are robust across all scenarios, with out-migration from a narrow coastal strip and in-migration widely spread across urban settings. However, the type of migration (e.g. proactive/reactive, managed/autonomous) depends on future socioeconomic developments that drive adaptive capacity, calling for decision-making that goes well beyond coastal issues.

Setback zones can effectively reduce exposure to sea-level rise in Europe.

Coastal space is one of the most valuable assets of the EU coastal member states, as the coast is highly urbanized. Hard engineering has traditionally been employed to protect communities in coastal lowlands, but as this alternative becomes less sustainable and more costly, coastal managers are increasingly turning to landuse planning strategies, such as setback zones or managed retreat. To explore the efficiency of these planning tools in reducing future urban exposure to sea-level rise and associated hazards, we developed spatially explicit projections of urban extent that account for different socio-economic futures and various types of setback zones. We find that the establishment of coastal setback zones can reduce the exposure of new urban development by at least 50% in the majority of EU countries by 2100. Our results emphasize that future urban exposure to sea-level rise will be significantly influenced by the ways in which we plan, design, and develop urban space in the EU coastal lowlands.

Two-year outcomes of leadless vs. transvenous single-chamber ventricular pacemaker in high-risk subgroups.

AIMS: This study compares clinical outcomes between leadless pacemakers (leadless-VVI) and transvenous ventricular pacemakers (transvenous ventricular permanent-VVI) in subgroups of patients at higher risk of pacemaker complications. METHODS AND RESULTS: This study is based on the Micra Coverage with Evidence Development (CED) study. Patients from the Micra CED study were considered in a high-risk subgroup if they had a diagnosis of chronic kidney disease Stages 4-5 (CKD45), end-stage renal disease, malignancy, diabetes, tricuspid valve disease (TVD), or chronic obstructive pulmonary disease (COPD) 12 months prior to pacemaker implant. A pre-specified set of complications and reinterventions were identified using diagnosis and procedure codes. Competing risks models were used to compare reinterventions and complications between leadless-VVI and transvenous-VVI patients within each subgroup; results were adjusted for multiple comparisons. A post hoc comparison of a composite outcome of reinterventions and device complications was conducted. Out of 27 991 patients, 9858 leadless-VVI and 12 157 transvenous-VVI patients have at least one high-risk comorbidity. Compared to transvenous-VVI patients, leadless-VVI patients in four subgroups [malignancy, HR 0.68 (0.48-0.95); diabetes, HR 0.69 (0.53-0.89); TVD, HR 0.60 (0.44-0.82); COPD, HR 0.73 (0.55-0.98)] had fewer complications, in three subgroups [diabetes, HR 0.58 (0.37-0.89); TVD, HR 0.46 (0.28-0.76); COPD, HR 0.51 (0.29-0.90)) had fewer reinterventions, and in four subgroups (malignancy, HR 0.52 (0.32-0.83); diabetes, HR 0.52 (0.35-0.77); TVD, HR 0.44 (0.28-0.70); COPD, HR 0.55 (0.34-0.89)] had lower rates of the combined outcome. CONCLUSION: In a real-world study, leadless pacemaker patients had lower 2-year complications and reinterventions rates compared with transvenous-VVI pacing in several high-risk subgroups. TRIAL REGISTRATION: ClinicalTrials.gov ID NCT03039712.

Do implantable loop recorders impact the survival of patients with recurrent unexplained syncope?

Aim: This study compares the outcomes of patients who receive an implantable loop recorder (ILR) for unexplained syncope to a control group without the diagnostic device in German claims data. Methods and materials: Patients with ILR were matched to a control group based on prior syncope events, age, gender and Charlson Comorbidity index (CCI). Survival, syncope hospitalizations, treatment and costs were compared. Results/conclusion: Four hundred and twelve ILR patients were matched with controls, mean age was 68, mean CCI was 2.7, 42% females. ILR patients lived on average 1.2 years longer than patients in the control group. Twenty-five percent of ILR patients received a therapeutic device compared with 5% in the control group. ILRs might help to diagnose and treat patients with positive impact on survival.

Future urban development exacerbates coastal exposure in the Mediterranean.

Changes in the spatial patterns and rate of urban development will be one of the main determinants of future coastal flood risk. Existing spatial projections of urban extent are, however, often available at coarse spatial resolutions, local geographical scales or for short time horizons, which limits their suitability for broad-scale coastal flood impact assessments. Here, we present a new set of spatially explicit projections of urban extent for ten countries in the Mediterranean, consistent with the Shared Socioeconomic Pathways (SSPs). To model plausible future urban development, we develop an Urban Change Model, which uses input variables such as elevation, population density or road network and an artificial neural network to project urban development on a regional scale. The developed future projections for the five SSPs indicate that accounting for the spatial patterns of urban development can lead to significant differences in the assessment of future coastal urban exposure. The increase in exposure in the Extended Low Elevation Coastal Zone (E-LECZ = area below 20 m of elevation) until 2100 can vary, by up to 104%, depending on the urban development scenario chosen. This finding highlights that accounting for urban development in long-term adaptation planning, e.g. in the form of land-use planning, can be an effective measure for reducing future coastal flood risk on a regional scale.

Burden of recurrent syncope and injuries and the usefulness of implantable cardiac monitors: insights from a nationwide longitudinal cohort analysis.

Aim: The study assesses the burden and costs of recurring unexplained syncope and injuries and the effectiveness of implantable loop recorders. Methods: The English national hospital database (Hospital Episode Statistics) was retrospectively analyzed. Results: 12,002 patients were identified with repeated syncope hospitalizations. 25% of patients were hospitalized at least once again for syncope, 9% of the patients were hospitalized at least once for an injury, causing substantial costs. In the second analysis: 10,902 patients implanted with an implantable cardiac monitor were tracked. By year 3, hospitalizations due to syncope had dropped by 60% versus pre-implantable cardiac monitor (ICM) levels. Conclusion: This study shows a high rate of recurrent syncope admissions and a parallel burden of hospitalizations for injuries. Use of an ICM appears to reduce syncope hospitalizations.

Non-linear interaction modulates global extreme sea levels, coastal flood exposure, and impacts.

We introduce a novel approach to statistically assess the non-linear interaction of tide and non-tidal residual in order to quantify its contribution to extreme sea levels and hence its role in modulating coastal protection levels, globally. We demonstrate that extreme sea levels are up to 30% (or 70 cm) higher if non-linear interactions are not accounted for (e.g., by independently adding astronomical and non-astronomical components, as is often done in impact case studies). These overestimates are similar to recent sea-level rise projections to 2100 at some locations. Furthermore, we further find evidence for changes in this non-linear interaction over time, which has the potential for counteracting the increasing flood risk associated with sea-level rise and tidal and/or meteorological changes alone. Finally, we show how accounting for non-linearity in coastal impact assessment modulates coastal exposure, reducing recent estimates of global coastal flood costs by ~16%, and population affected by ~8%.

Coastal flood risks in China through the 21st century - An application of DIVA.

China experiences frequent coastal flooding, with nearly US$ 77 billion of direct economic losses and over 7,000 fatalities reported from 1989 to 2014. Flood damages are likely to grow due to climate change induced sea-level rise and increasing exposure if no further adaptation measures are taken. This paper quantifies potential damage and adaptation costs of coastal flooding in China over the 21st Century, including the effects of sea-level rise. It develops and utilises a new, detailed coastal database of China developed within the Dynamic Interactive Vulnerability Assessment (DIVA) model framework. The refined database provides a more realistic spatial representation of coasts, with more than 2700 coastal segments, covering 28,966 km of coastline. Over 50% of China's coast is artificial, representing defended coast and/or claimed land. Coastal flood damage and adaptation costs for China are assessed for different Representative Concentration Pathway (RCP) and Shared Socio-economic Pathways (SSP) combinations representing climate change and socio-economic change and two adaptation strategies: no upgrade of currently existing defences and maintaining current protection levels. By 2100, 0.7-20.0 million people may be flooded/yr and US$ 67-3,308 billion damages/yr are projected without upgrade to defences. In contrast, maintaining the current protection level would reduce those numbers to 0.2-0.4 million people flooded/yr and US$ 22-60 billion/yr flood costs by 2100, with protection investment costs of US$ 8-17 billion/yr. In 2100, maintaining current protection levels, dikes costs are two orders of magnitude smaller than flood costs across all scenarios, even without accounting for indirect damages. This research improves on earlier national assessments of China by generating a wider range of projections, based on improved datasets. The information delivered in this study will help governments, policy-makers, insurance companies and local communities in China understand risks and design appropriate strategies to adapt to increasing coastal flood risk in an uncertain world.

Pacemaker complications and costs: a nationwide economic study.

Aims: Novel leadless pacemakers (LPMs) may reduce complications and associated costs related to conventional pacemaker systems. This study sought to estimate the incidence and associated costs of traditional pacemaker complications, in those patients who were eligible for LPM implantation. Methods: A retrospective analysis was conducted on the French National Hospital Database (PMSI), including all patients implanted with a pacemaker in France in 2012, who could have alternatively received an LPM. Complication rates and their associated costs 3 years post-implantation were estimated from the perspective of the French social security system. Results: From a total of 65,553 patients, 11,770 (18%) met the inclusion criteria. Overall, 618 patients (5.3%) had a record of pacemaker complications during follow-up, of which 89% were related to the lead and pocket. Most common were pocket bleeding, lead- or generator-related mechanical complications, and pneumothorax. Overall, the mean cost of pacemaker complications per patient was €6,674 ± 3,867 at 3 years. Specifically, €7,143 ± 2,685 for pocket bleeding, €5,123 ± 2,676 for pneumothorax, and €6,020 ± 3,272 for mechanical complications. Conclusions: Major complications associated with the lead and pocket of conventional pacemaker systems are still common, and these represent a significant burden to healthcare systems as they generate substantial costs.

Cost-effectiveness of an insertable cardiac monitor in a high-risk population in the UK.

Objective: To evaluate the cost-effectiveness of insertable cardiac monitors (ICMs) compared with standard of care (SoC) for detecting atrial fibrillation (AF) in patients at high risk of stroke (CHADS2 >2), using a UK National Health Service (NHS) perspective. Methods: Using patient characteristics and clinical data from the REVEAL AF trial, a Markov model assessed the cost-effectiveness of detecting AF with an ICM compared with SoC. Costs and benefits were extrapolated across modelled patient lifetime. Ischaemic and haemorrhagic strokes, intracranial and extracranial haemorrhages and minor bleeds were modelled. Diagnostic and device costs were included, plus costs of treating stroke and bleeding events and costs of oral anticoagulants (OACs). Costs and health outcomes, measured as quality-adjusted life years (QALYs), were discounted at 3.5% per annum. One-way deterministic and probabilistic sensitivity analyses (PSA) were undertaken. Results: The total per-patient cost for ICM was £13 360 versus £11 936 for SoC (namely, annual 24 hours Holter monitoring). ICMs generated a total of 6.50 QALYs versus 6.30 for SoC. The incremental cost-effectiveness ratio (ICER) was £7140/QALY gained, below the £20 000/QALY acceptability threshold. ICMs were cost-effective in 77.4% of PSA simulations. The number of ICMs needed to prevent one stroke was 21 and to cause a major bleed was 37. ICERs were sensitive to assumed proportions of patients initiating or discontinuing OAC after AF diagnosis, type of OAC used and how intense the traditional monitoring was assumed to be under SoC. Conclusions: The use of ICMs to identify AF in a high-risk population is cost-effective for the UK NHS.

Author Correction: Future response of global coastal wetlands to sea-level rise.

Change history: In Fig. 2b of this Letter, 'Relative wetland change (km2)' should have read 'Relative wetland change (%)' and equations (2) and (3) have been changed from 'RSLRcrit = (m × TRe) × Sed + i' and 'Sedcrit = (RSLR - i)/(m × TRe)', respectively. The definition of the variables in equation (2) has been updated. These errors have been corrected online.

Complications and associated healthcare costs of transvenous cardiac pacemakers in Germany.

Aim: This study evaluated the occurrence and associated costs of pacemaker complications in Germany from 2010 to 2013. Patients & methods: Patients with a de novo or replacement implantation of a single or dual chamber pacemaker between 2010 and 2013 were followed for 12 months post-implant using German health insurance claims data. A case-control analysis was performed using propensity score matching to estimate the costs of complications. Results: Out of 12,922 implanted patients, 12.0% had a complication in the year following the implant. Complications related to lead and pocket were found in 10.2% of all implanted patients; infections occurred in 1.7% patients. Healthcare costs up to 36 months post complication were on average €4627 higher than for pacemaker patients without a complication. Conclusion: Pacemaker complications are common and represent a burden for patients and healthcare systems generating substantial costs. Most of the pacemaker complications involved the pacing lead or pacemaker pocket.

Health care cost analysis of enhanced pacing modalities in bradycardia patients: Portuguese case study on the results of the MINERVA trial.

INTRODUCTION: The MINERVA trial established that atrial preventive pacing and atrial antitachycardia pacing (DDDRP) in combination with managed ventricular pacing (MVP) reduces progression to permanent atrial fibrillation (AF) in patients with paroxysmal or persistent AF and bradycardia who need cardiac pacing, compared to standard dual-chamber pacing (DDDR). It was shown that AF-related health care utilization was significantly lower in the DDDRP + MVP group than in the control group. Cost analysis demonstrated significant savings related to this new algorithm, based on health care costs from the USA, Italy, Spain and the UK. OBJECTIVE: To calculate the savings associated with reduced health care utilization due to enhanced pacing modalities in the Portuguese setting. METHODS: The impact on costs was estimated based on tariffs for AF-related hospitalizations and costs for emergency department and outpatient visits in Portugal. RESULTS: The MINERVA trial showed a 42% reduction in AF-related health care utilization thanks to the new algorithm. In Portugal, this represents a potential cost saving of 2323 euros per 100 patients in the first year and 17118 euros over a 10-year period. Considering the number of patients who could benefit from this new algorithm, Portugal could save a total of 75369 euros per year and 555410 euros over 10 years. Additional savings could accrue if heart failure and stroke hospitalizations were considered. CONCLUSION: The combination of atrial preventive pacing, atrial antitachycardia pacing and an algorithm to minimize the detrimental effect of right ventricular pacing reduces recurrent and permanent AF. The new DDDRP + MVP pacing mode could contribute to significant costs savings in the Portuguese health care setting.

Future response of global coastal wetlands to sea-level rise.

The response of coastal wetlands to sea-level rise during the twenty-first century remains uncertain. Global-scale projections suggest that between 20 and 90 per cent (for low and high sea-level rise scenarios, respectively) of the present-day coastal wetland area will be lost, which will in turn result in the loss of biodiversity and highly valued ecosystem services1-3. These projections do not necessarily take into account all essential geomorphological4-7 and socio-economic system feedbacks8. Here we present an integrated global modelling approach that considers both the ability of coastal wetlands to build up vertically by sediment accretion, and the accommodation space, namely, the vertical and lateral space available for fine sediments to accumulate and be colonized by wetland vegetation. We use this approach to assess global-scale changes in coastal wetland area in response to global sea-level rise and anthropogenic coastal occupation during the twenty-first century. On the basis of our simulations, we find that, globally, rather than losses, wetland gains of up to 60 per cent of the current area are possible, if more than 37 per cent (our upper estimate for current accommodation space) of coastal wetlands have sufficient accommodation space, and sediment supply remains at present levels. In contrast to previous studies1-3, we project that until 2100, the loss of global coastal wetland area will range between 0 and 30 per cent, assuming no further accommodation space in addition to current levels. Our simulations suggest that the resilience of global wetlands is primarily driven by the availability of accommodation space, which is strongly influenced by the building of anthropogenic infrastructure in the coastal zone and such infrastructure is expected to change over the twenty-first century. Rather than being an inevitable consequence of global sea-level rise, our findings indicate that large-scale loss of coastal wetlands might be avoidable, if sufficient additional accommodation space can be created through careful nature-based adaptation solutions to coastal management.

Stabilization of global temperature at 1.5°C and 2.0°C: implications for coastal areas.

The effectiveness of stringent climate stabilization scenarios for coastal areas in terms of reduction of impacts/adaptation needs and wider policy implications has received little attention. Here we use the Warming Acidification and Sea Level Projector Earth systems model to calculate large ensembles of global sea-level rise (SLR) and ocean pH projections to 2300 for 1.5°C and 2.0°C stabilization scenarios, and a reference unmitigated RCP8.5 scenario. The potential consequences of these projections are then considered for global coastal flooding, small islands, deltas, coastal cities and coastal ecology. Under both stabilization scenarios, global mean ocean pH (and temperature) stabilize within a century. This implies significant ecosystem impacts are avoided, but detailed quantification is lacking, reflecting scientific uncertainty. By contrast, SLR is only slowed and continues to 2300 (and beyond). Hence, while coastal impacts due to SLR are reduced significantly by climate stabilization, especially after 2100, potential impacts continue to grow for centuries. SLR in 2300 under both stabilization scenarios exceeds unmitigated SLR in 2100. Therefore, adaptation remains essential in densely populated and economically important coastal areas under climate stabilization. Given the multiple adaptation steps that this will require, an adaptation pathways approach has merits for coastal areas.This article is part of the theme issue 'The Paris Agreement: understanding the physical and social challenges for a warming world of 1.5°C above pre-industrial levels'.

A Mediterranean coastal database for assessing the impacts of sea-level rise and associated hazards.

We have developed a new coastal database for the Mediterranean basin that is intended for coastal impact and adaptation assessment to sea-level rise and associated hazards on a regional scale. The data structure of the database relies on a linear representation of the coast with associated spatial assessment units. Using information on coastal morphology, human settlements and administrative boundaries, we have divided the Mediterranean coast into 13 900 coastal assessment units. To these units we have spatially attributed 160 parameters on the characteristics of the natural and socio-economic subsystems, such as extreme sea levels, vertical land movement and number of people exposed to sea-level rise and extreme sea levels. The database contains information on current conditions and on plausible future changes that are essential drivers for future impacts, such as sea-level rise rates and socio-economic development. Besides its intended use in risk and impact assessment, we anticipate that the Mediterranean Coastal Database (MCD) constitutes a useful source of information for a wide range of coastal applications.