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Background: Literature illustrates an association between adverse outcomes and lower socioeconomic status (SES) in patients with critical cardiovascular presentations; however. limited data exist on complete heart block (CHB) outcomes in the context of SES., Objectives: The purpose of this study was to assess the association of SES (using zip code income quartiles) with the outcomes of CHB cases., Methods: We queried the 2016-2019 Nationwide Inpatient Sample and identified CHB as the primary diagnosis. We compared in-hospital outcomes based on zip code mean income quartiles (≤2 [< $59,000] vs ≥3). The primary outcome was mortality. Secondary outcomes included total and early permanent pacemaker (PPM) and temporary pacemaker (TPM) use, cardiogenic shock, palliative care involvement, mechanical ventilation use, length of stay (LOS), and total charges. Multivariable regression models were used to adjust for potential confounders., Results: Of 150,265 CHB hospitalizations, 76,635 (51%) involved patients with a lower income quartile. Lower quartiles were associated with lower odds of early PPM use (adjusted odds ratio [aOR] 0.86; 95% confidence interval [CI] 0.81-0.90) and higher odds of in-hospital mortality (aOR 1.23; 95% CI 1.05-1.46), total TPM use (aOR 1.08; 95% CI 1.02-1.14), palliative care (aOR 1.2; 95% CI 1.02-1.43), mechanical ventilation use (aOR 1.11; 95% CI 1.01-1.23), cardiogenic shock (aOR 1.15; 95% CI 1.01-1.31), and longer LOS (4 days vs 3.6 days; P <.001) compared to patients in higher quartiles., Conclusion: Patients with lower income admitted for CHB were less likely to receive an early PPM and had higher adverse outcomes compared to patients with higher income., Competing Interests: Disclosures Dr Linzer is supported through his employer Hennepin Healthcare for work on burnout reduction projects by the AMA, IHI, Optum Office of Provider Advancement, and other large health systems, as well as the NIH and AHRQ. All other authors have no conflicts of interest to disclose., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Prior analyses of the relationship between insurance status and receipt of tests and procedures have yielded conflicting findings and have focused on outpatient care. We sought to characterize the relationship between primary payer and diagnostic and procedural intensity, comparing rates of cardiac tests and procedures in matched hospitalized Medicaid and commercially insured patients., Methods and Results: We created a propensity score-matched sample of Medicaid and commercially insured adults hospitalized at all acute care hospitals in Kentucky, Maryland, New Jersey, and North Carolina from 2016 to 2018. The main outcome was receipt of a cardiac test or procedure: echocardiogram, stress test, cardiac catheterization (elective, in acute coronary syndrome, in ST-segment-elevation myocardial infarction), and pacemaker and subcutaneous cardiac rhythm monitor implantation. Generalized linear models with a hospital-specific indicator variable were estimated to calculate the adjusted odds of a commercially insured patient receiving a given test or procedure relative to a Medicaid patient. Models controlled for race, ethnicity, and zip code income quartile. Commercially insured patients were more likely to receive each cardiac test or procedure, with adjusted odds ratios ranging from 1.16 (95% CI, 1.00-1.34) for cardiac catheterization in ST-segment-elevation myocardial infarction to 1.40 (95% CI, 1.27-1.54) for pacemaker implantation., Conclusions: Hospitalized commercially insured patients were more likely to undergo a range of cardiac tests and procedures, some of which may represent low-value care. This may be driven by a combination of physician and patient preference, financial incentives, and social determinants of health. Our findings support the need for hospital payment models focused on increasing value and reducing inequities.

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., Competing Interests: Conflict of interest: D.J.W. has received research grants and consultancy fees from Medtronic and Boston Scientific and educational fees from Abbot. M.E.T. has received speaker’s fees from Abbot, Biotronik, Boston Scientific, Medtronic, and Microport CRM. J.Z., C.W., R.H., and J.M. are employees of Medtronic, Inc. M.F.E.-C. has received consultant fees from Medtronic and Boston Scientific., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Introduction: Leadless pacemakers (LPM) have established themselves as the important therapeutic modality in management of selected patients with symptomatic bradycardia. To determine real-world utilization and in-hospital outcomes of LPM implantation since its approval by the Food and Drug Administration in 2016., Methods: For this retrospective cohort study, data were extracted from the National Inpatient Sample database from the years 2016-2020. The outcomes analyzed in our study included implantation trends of LPM over study years, mortality, major complications (defined as pericardial effusion requiring intervention, any vascular complication, or acute kidney injury), length of stay, and cost of hospitalization. Implantation trends of LPM were assessed using linear regression. Using years 2016-2017 as a reference, adjusted outcomes of mortality, major complications, prolonged length of stay (defined as >6 days), and increased hospitalization cost (defined as median cost >34 098$) were analyzed for subsequent years using a multivariable logistic regression model., Results: There was a gradual increased trend of LPM implantation over our study years (3230 devices in years 2016-2017 to 11 815 devices in year 2020, p for trend <.01). The adjusted mortality improved significantly after LPM implantation in subsequent years compared to the reference years 2016-2017 (aOR for the year 2018: 0.61, 95% CI: 0.51-0.73; aOR for the year 2019: 0.49, 95% CI: 0.41-0.59; and aOR for the year 2020: 0.52, 95% CI: 0.44-0.62). No differences in adjusted rates of major complications were demonstrated over the subsequent years. The adjusted cost of hospitalization was higher for the years 2019 (aOR: 1.33, 95% CI: 1.22-1.46) and 2020 (aOR: 1.69, 95% CI: 1.55-1.84)., Conclusion: The contemporary US practice has shown significantly increased implantation rates of LPM since its approval with reduced rates of inpatient mortality., (© 2024 The Authors. Journal of Cardiovascular Electrophysiology published by Wiley Periodicals LLC.)

Purpose of Review: Heart failure (HF) is a major public health problem worldwide, affecting more than 64 million people [1]. The complex and severe nature of HF presents challenges in providing cost-effective care as patients often require multiple hospitalizations and treatments. This review of relevant studies with focus on the last 10 years summarizes the health and economic implications of various HF treatment options in Europe and beyond. Although the main cost drivers in HF treatment are clinical (re)admission and decompensation of HF, an assessment of the economic impacts of various other device therapy options for HF care are included in this review. This includes: cardiovascular implantable electronic devices (CIEDs) such as cardiac-resynchronisation-therapy devices that include pacemaking (CRT-P), cardiac-resynchronisation-therapy devices that include defibrillation (CRT-D), implantable cardioverter/defibrillators (ICDs) and various types of pacemakers. The impact of (semi)automated (tele)monitoring as a relevant factor for increasing both the quality and economic impact of care is also taken into consideration. Quality of life adjusted life years (QALYs) are used in the overall context as a composite metric reflecting quantity and quality of life as a standardized measurement of incremental cost-effectiveness ratios (ICER) of different device-based HF interventions., Recent Findings: In terms of the total cost of different devices, CRT-Ds were found in several studies to be more expensive than all other devices in regards to runtime and maintenance costs including (re)implantation. In the case of CRT combined with an implantable cardioverter-defibrillator (CRT-D) versus ICD alone, CRT-D was found to be the most cost-effective treatment in research work over the past 10 years. Further comparison between CRT-D vs. CRT-P does not show an economic advantage of CRT-D as a minority of patients require shock therapy. Furthermore, a positive health economic effect and higher survival rate is seen in CRT-P full ventricular stimulation vs. right heart only stimulation. Telemedical care has been found to provide a positive health economic impact for selected patient groups-even reducing patient mortality. For heart failure both in ICD and CRT-D subgroups the given telemonitoring benefit seems to be greater in higher-risk populations with a worse HF prognosis. In patients with HF, all CIED therapies are in the range of commonly accepted cost-effectiveness. QALY and ICER calculations provide a more nuanced understanding of the economic impact these therapies create in the healthcare landscape. For severe cases of HF, CRT-D with telemedical care seems to be the better option from a health economic standpoint, as therapy is more expensive, but costs per QALY range below the commonly accepted threshold., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Telemonitoring patients with cardiac implantable electronic devices (CIEDs) can improve their care management. However, the results of cost-effectiveness studies are heterogeneous. Therefore, it is still a matter of debate whether telemonitoring is worth the investment., Objective: This systematic review aims to investigate the cost-effectiveness of telemonitoring patients with CIEDs, focusing on its key drivers, and the impact of the varying perspectives., Methods: A systematic review was performed in PubMed, Web of Science, Embase, and EconLit. The search was completed on July 7, 2022. Studies were included if they fulfilled the following criteria: patients had a CIED, comparison with standard care, and inclusion of health economic evaluations (eg, cost-effectiveness analyses and cost-utility analyses). Only complete and peer-reviewed studies were included, and no year limits were applied. The exclusion criteria included studies with partial economic evaluations, systematic reviews or reports, and studies without standard care as a control group. Besides general study characteristics, the following outcome measures were extracted: impact on total cost or income, cost or income drivers, cost or income drivers per patient, cost or income drivers as a percentage of the total cost impact, incremental cost-effectiveness ratios, or cost-utility ratios. Quality was assessed using the Consensus Health Economic Criteria checklist., Results: Overall, 15 cost-effectiveness analyses were included. All studies were performed in Western countries, mainly Europe, and had primarily a male participant population. Of the 15 studies, 3 (20%) calculated the incremental cost-effectiveness ratio, 1 (7%) the cost-utility ratio, and 11 (73%) the health and cost impact of telemonitoring. In total, 73% (11/15) of the studies indicated that telemonitoring of patients with implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy ICDs was cost-effective and cost-saving, both from a health care and patient perspective. Cost-effectiveness results for telemonitoring of patients with pacemakers were inconclusive. The key drivers for cost reduction from a health care perspective were hospitalizations and scheduled in-office visits. Hospitalization costs were reduced by up to US $912 per patient per year. Scheduled in-office visits included up to 61% of the total cost reduction. Key drivers for cost reduction from a patient perspective were loss of income, cost for scheduled in-office visits and transport. Finally, of the 15 studies, 8 (52%) reported improved quality of life, with statistically significance in only 1 (13%) study (P=.03)., Conclusions: From a health care and patient perspective, telemonitoring of patients with an ICD or a cardiac resynchronization therapy ICD is a cost-effective and cost-saving alternative to standard care. Inconclusive results were found for patients with pacemakers. However, telemonitoring can lead to a decrease in providers' income, mainly due to a lack of reimbursement. Introducing appropriate reimbursement could make telemonitoring sustainable for providers while still being cost-effective from a health care payer perspective., Trial Registration: PROSPERO CRD42022322334; https://tinyurl.com/puunapdr., (©Sarah Raes, Andrea Prezzi, Rik Willems, Hein Heidbuchel, Lieven Annemans. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 19.04.2024.)

Background: The use of artificial cardiac pacemakers has grown steadily in line with the aging population., Objectives: To determine the rates of hospital readmissions and complications after pacemaker implantation or pulse generator replacement and to assess the impact of these events on annual treatment costs from the perspective of the Unified Health System (SUS)., Methods: A prospective registry, with data derived from clinical practice, collected during index hospitalization and during the first 12 months after the surgical procedure. The cost of index hospitalization, the procedure, and clinical follow-up were estimated according to the values reimbursed by SUS and analyzed at the patient level. Generalized linear models were used to study factors associated with the total annual treatment cost, adopting a significance level of 5%., Results: A total of 1,223 consecutive patients underwent initial implantation (n=634) or pulse generator replacement (n=589). Seventy episodes of complication were observed in 63 patients (5.1%). The incidence of hospital readmissions within one year was 16.4% (95% CI 13.7% - 19.6%) after initial implants and 10.6% (95% CI 8.3% - 13.4%) after generator replacements. Chronic kidney disease, history of stroke, length of hospital stays, need for postoperative intensive care, complications, and hospital readmissions showed a significant impact on the total annual treatment cost., Conclusions: The results confirm the influence of age, comorbidities, postoperative complications, and hospital readmissions as factors associated with increased total annual treatment cost for patients with pacemakers.

Objectives: New versions of balloon-expandable and self-expandable valves for transcatheter aortic valve replacement (TAVR) have been developed, but few studies have examined the outcomes associated with these devices using national-level data. This study aimed to elucidate the clinical and economic outcomes of TAVR for aortic stenosis in Japan through an analysis of real-world data., Methods: This retrospective cohort study was performed using data from patients with aortic stenosis who had undergone transfemoral TAVR with Edwards SAPIEN 3, Medtronic CoreValve, or Medtronic Evolut R valves throughout Japan from April 2016 to March 2018. Pacemaker implantation, mortality, and health expenditure were examined for each valve type during hospitalization and at 1 month, 3 months, 6 months, and 1 year. Generalized linear regression models and Cox proportional hazards models were used to examine the associations between the valve types and outcomes., Results: We analyzed 7244 TAVR cases (SAPIEN 3: 5276, CoreValve: 418, and Evolut R: 1550) across 145 hospitals. The adjusted 1-year expenditures for SAPIEN 3, CoreValve, and Evolut R were $79 402, $76 125, and $75 527, respectively; SAPIEN 3 was significantly more expensive than the other valves (P < .05). The pacemaker implantation hazard ratios (95% confidence intervals) for CoreValve and Evolut R were significantly higher (P < .001) than SAPIEN 3 at 2.61 (2.07-3.27) and 1.80 (1.53-2.12), respectively. The mortality hazard ratios (95% confidence intervals) for CoreValve and Evolut R were not significant at 1.11 (0.84-1.46) and 1.22 (0.97-1.54), respectively., Conclusions: SAPIEN 3 users had generally lower pacemaker implantation and mortality but higher expenditures than CoreValve and Evolut R users., (Copyright © 2020 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Background: A significant percentage of patients who acutely develop high-grade atrioventricular block after valve surgery will ultimately recover, yet the ability to predict recovery is limited. The purpose of this analysis was to evaluate the cost-effectiveness of two different management strategies for the timing of permanent pacemaker implantation for new heart block after valve surgery., Methods: A cost-effectiveness model was developed using costs and probabilities of short- and long-term complications of pacemaker placement, short-term atrioventricular node recovery, intensive care unit stays, and long-term follow-up. We aggregated the total expected cost and utility of each option over a 20-y period. Quality-adjusted survival with a pacemaker was estimated from the literature and institutional patient-reported outcomes. Primary decision analysis was based on an expected recovery rate of 36.7% at 12 d with timing of pacemaker implantation: early placement (5 d) versus watchful waiting for 12 d., Results: A strategy of watchful waiting was more costly ($171,798 ± $45,695 versus $165,436 ± $52,923; P < 0.0001) but had a higher utility (9.05 ± 1.36 versus 8.55 ± 1.33 quality-adjusted life years; P < 0.0001) than an early pacemaker implantation strategy. The incremental cost-effectiveness ratio of watchful waiting was $12,724 per quality-adjusted life year. The results are sensitive to differences in quality-adjusted survival and rates of recovery of atrioventricular node function., Conclusions: Watchful waiting for pacemaker insertion is a cost-effective management strategy compared with early placement for acute atrioventricular block after valve surgery. Although this is cost-effective from a population perspective, clinical risk scores predicting recovery will aid in personalized decision-making., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objective: To characterize contemporary pacemaker procedure trends., Methods: Nationwide analysis of pacemaker procedures and costs between 2008 and 2017 in Australia. The main outcome measures were total, age- and gender-specific implant, replacement, and complication rates, and costs., Results: Pacemaker implants increased from 12,153 to 17,862. Implantation rates rose from 55.3 to 72.6 per 100,000, a 2.8% annual increase (incidence rate ratio [IRR] 1.028; 95% CI, 1.02-1.04; p < .001). Pacemaker implants in the 80+ age group were 17.37-times higher than the < 50 group (95% CI 16.24-18.59; p < .001), and in males were 1.48-times higher than in females (95% CI 1.42-1.55; p < .001). However, there were similar increases according to age (p = .10) and gender (p = .68) over the study period. Left ventricular lead rates were stable (IRR 0.995; 95% CI 0.98-1.01; p = .53). Generator replacements decreased from 20.5 to 18.3 per 100,000 (IRR 0.975; 95% CI 0.97-0.98; p < .001). Although procedures for generator-related complications were stable (IRR 0.995; 95% CI 0.98-1.01; p = .54), those for lead-related complications decreased (IRR 0.985; 95% CI 0.98-0.99; p < .001). Rates for all pacemaker procedures were consistently greater in males (p < .001). Although annual costs of all pacemaker procedures increased from $178 million to $329 million, inflation-adjusted costs were more stable, rising from $294 million to $329 million., Conclusions: Increasing demand for pacemaker implants is driven by the ageing population and rising rates across all ages, while replacement and complication procedure rates appeared more stable. Males have consistently greater pacemaker procedure rates than females. Our findings have significant clinical and public health implications for healthcare resource planning., (© 2021 Wiley Periodicals LLC.)

Background: National trends and costs associated with remote and in-office interrogations of pacemakers and implantable cardioverter-defibrillators (ICDs) have not been previously described., Objective: The purpose of this study was to evaluate utilization and Medicare spending for remote monitoring and in-office interrogations for pacemakers and ICDs., Methods: We performed a retrospective cohort study of claims and spending for remote and in-office interrogations of pacemakers and ICDs for Medicare fee-for-service beneficiaries from 2012 to 2015. Aggregate and per-beneficiary claims and spending were calculated for each device type., Results: Among all patients, 41.9% were female and the mean age was 78.3 years. From 2012 to 2015, remote monitoring utilization increased sharply. Aggregate professional remote monitoring claims for pacemakers increased by 61.3% and for ICDs by 5.6%, with an increase in technical claims (combined for pacemakers and ICDs) of 32.8%. Spending on all remote and in-office interrogations for these devices totaled $160 million per year, with remote costs increasing nearly 25% from $45.4 million in 2012 to $56.7 million in 2015. At the beneficiary level, remote interrogations increased for pacemakers from 0.6 to 0.9 per year, and for ICDs from 1.3 to 1.4 per year, whereas in-office interrogations decreased from 2.8 to 2.7 per year and from 3.0 to 2.9 per year, respectively. Beneficiary-level analysis revealed increased expenditures on remote interrogation offset by decreases in in-office expenditures, with total annual spending decreasing by $2 and $5 per beneficiary, respectively., Conclusion: Remote monitoring utilization increased substantially from 2012 to 2015, whereas annual costs per beneficiary decreased., (Copyright © 2020 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Implantable cardiac electronic device (ICED) infections are associated with significant morbidity, mortality and cost. The aim of this study was to perform the first analysis for the cost of ICED infection in Australia. Secondary aims were to provide an update on the incidence, burden and outcomes of ICED infections and an analysis of the hospital ICD-10 codes used for ICED infection admissions., Methods: We performed a retrospective study of ICED implantations and infections in the Barwon Health region (BH) and the state of Victoria (Vic) from January 2010 to December 2015 inclusive., Results: Sensitivity of ICD-10 code T82.7 was 63.4% (95% CI 46.9-77.8) and specificity was 14.5% (95% CI 9.9-21.1). Infection rates were 1.4 admissions/100,000 persons/year (SD 0.7) in BH and estimated to be 7.9 admissions/100,000 persons/year (95% CI 6.8-9.0) in Vic. Average cost of infection was $670,334/year in BH and estimated to be $14,879,979/year in Vic., Conclusion: Rates of ICED infection are decreasing in Victoria. Infections are associated with significant morbidity and cost., Competing Interests: Disclosures This study was funded by a Medtronic Untied Grant, Medtronic Australasia. Declarations of interest: none. This study complies with the Declaration of Helsinki. The research protocol was approved by the Barwon Health Research Ethics, Governance and Integrity Unit (approval number 16/213)., (Copyright © 2019 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.)

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.

Background: Current understanding of the impact of cardiac implantable electronic device (CIED) infection is based on retrospective analyses from medical records or administrative claims data. The WRAP-IT (Worldwide Randomized Antibiotic Envelope Infection Prevention Trial) offers an opportunity to evaluate the clinical and economic impacts of CIED infection from the hospital, payer, and patient perspectives in the US healthcare system., Methods: This was a prespecified, as-treated analysis evaluating outcomes related to major CIED infections: mortality, quality of life, disruption of CIED therapy, healthcare utilization, and costs. Payer costs were assigned using medicare fee for service national payments, while medicare advantage, hospital, and patient costs were derived from similar hospital admissions in administrative datasets., Results: Major CIED infection was associated with increased all-cause mortality (12-month risk-adjusted hazard ratio, 3.41 [95% CI, 1.81-6.41]; P <0.001), an effect that sustained beyond 12 months (hazard ratio through all follow-up, 2.30 [95% CI, 1.29-4.07]; P =0.004). Quality of life was reduced ( P =0.004) and did not normalize for 6 months. Disruptions in CIED therapy were experienced in 36% of infections for a median duration of 184 days. Mean costs were $55 547±$45 802 for the hospital, $26 867±$14 893, for medicare fee for service and $57 978±$29 431 for Medicare Advantage (mean hospital margin of -$30 828±$39 757 for medicare fee for service and -$6055±$45 033 for medicare advantage). Mean out-of-pocket costs for patients were $2156±$1999 for medicare fee for service, and $1658±$1250 for medicare advantage., Conclusions: This large, prospective analysis corroborates and extends understanding of the impact of CIED infections as seen in real-world datasets. CIED infections severely impact mortality, quality of life, healthcare utilization, and cost in the US healthcare system. Registration: URL: https://www.clinicaltrials.gov Unique Identifier: NCT02277990.

Purpose: Several external cardiac monitors (ECMs) have recently been developed. These have never been compared to 'gold standard' monitoring with concurrently implanted DDDRP pacemakers. The accuracy of AF detection of Zio XT Monitor (ZM), NUUBO Vest (NV) and Carnation Ambulatory Monitor (CAM) compared with Novacor 'R' Test 4 (RT) in patients (pts) with DDDRP PPM advanced Holters as the comparator, was evaluated., Methods: Twenty-one pts. with AF and a DDDRP PPM, each acting as their own control subject, wore every ECM for 2 weeks in randomized order. PPM downloads were performed at application and removal. Device ECGs were compared for AF burden and individual AF episodes with PPM Holters. Pt acceptability, wear time, costs and time expenditure were evaluated., Results: RT AF burden was less accurate than the ZM, NV or CAM (p < 0.05). Probability of inaccurate AF diagnosis was higher for RT than ZM or CAM OR 12.31 and 5.85, respectively (p = 0.025 and p = 0.042). ZM wear time was longer than the RT: 307 h vs. 224 h; p = 0.02. Acceptability was greater for CAM than RT (1.86 ± 2.63 compared with 0.57 ± 1.17 for CAM; p = 0.024). All ECMs were more expensive than RT (p < 0.00001)., Conclusions: All new ECMs were more expensive than the RT system; however, the ZM, NV and CAM are all more accurate than current standard practice RT device in AF burden assessment. The RT is more likely to give inaccurate diagnoses than ZM or CAM. This may have clinical implications.

Background: Cardiac implantable electronic device transvenous (TV) lead reoperations are projected to increase, and robust economic data are needed to assess the resulting financial impact and the cost-effectiveness of prevention and treatment strategies. This study estimates Medicare costs, and describes patterns of complications, in patients who underwent TV lead reoperation., Methods and Results: Medicare data (2010-2014) were used to identify patients who underwent TV lead reoperation. Cumulative costs to Medicare, and rates of infection and mechanical complications were calculated from 180 days before, to 180 days after, lead reoperation. Multivariate analysis was used to estimate adjusted costs, and to examine the impact of complications on medical resource use and costs. There were 1691 patients, 63.2% of whom underwent inpatient lead reoperation. Overall, the mean age was 78.2 years, 39.6% were female, and 92.3% were white. The mean cumulative cost was $36 199 (95% confidence interval [CI], $31 864-$40 535) for TV lead repositioning, $27 701 (95% CI, $19 869-$35 534) for repair, and $54 442 (95% CI, $51 651-$57 233) for removal. Underlying infection was associated with increased odds of inpatient reoperation and of lead removal, as well as longer length of stay and higher costs., Conclusions: The economic consequences of TV lead reoperation are substantial. Strategies aimed at reducing reoperation, particularly lead removal, are likely to result in considerable cost offsets., (© 2020 Wiley Periodicals, Inc.)

The rate of cardiac implantable electronic device (CIED) infection is increasing with time. We sought to determine the predictors, relative mortality, and cost burden of early-, mid- and late-onset CIED infections. We conducted a retrospective cohort study of all CIED implantations in Ontario, Canada between April 2013 and March 2016. The procedures and infections were identified in validated, population-wide health-care databases. Infection onset was categorized as early (0-30 days), mid (31-182 days) and late (183-365 days). Cox proportional hazards regression was used to assess the mortality impact of CIED infections, with infection modelled as a time-varying covariate. A generalized linear model with a log-link and γ distribution was used to compare health-care system costs by infection status. Among 17 584 patients undergoing CIED implantation, 215 (1.2%) developed an infection, including 88 early, 85 mid, and 42 late infections. The adjusted hazard ratio (aHR) of death was higher for patients with early (aHR 2.9, 95% CI 1.7-4.9), mid (aHR 3.3, 95% CI 1.9-5.7) and late (aHR 19.9, 95% CI 9.9-40.2) infections. Total mean 1-year health costs were highest for late-onset (mean Can$113 778), followed by mid-onset (mean Can$85 302), and then early-onset (Can$75 415) infections; costs for uninfected patients were Can$25 631. After accounting for patient and procedure characteristics, there was a significant increase in costs associated with early- (rate ratio (RR) 3.1, 95% CI 2.3-4.1), mid- (RR 2.8, 95% CI 2.4-3.3) and late- (RR 4.7, 95% CI 3.6-6.2) onset infections. In summary, CIED infections carry a tremendous clinical and economic burden, and this burden is disproportionately high for late-onset infections., (Copyright © 2019 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.)

Introduction: The aim of our study was to perform an economic assessment in order to check whether or not telemonitoring of users with pacemakers offers a cost-effective alternative to traditional follow-up in outpatient clinics., Methods: We used effectiveness and cost data from the NORDLAND trial, which is a controlled, randomized, non-masked clinical trial. Fifty patients were assigned to receive either telemonitoring (TM; n = 25) or conventional monitoring (CM; n = 25) and were followed up for 12 months after the implantation. A cost-utility analysis was performed in terms of additional costs per additional Quality-Adjusted Life Year (QALY) attained from the perspectives of the Norwegian National Healthcare System and patients and their caregivers., Results: Effectiveness was similar between alternatives (TM: 0.7804 [CI: 0.6864 to 0.8745] vs. CM: 0.7465 [CI: 0.6543 to 0.8387]), while cost per patient was higher in the RM group, both from the Norwegian NHS perspective (TM: €2,079.84 [CI: 0.00 to 4,610.58] vs. €271.97 [CI: 158.18 to 385.76]; p = 0.147) and including the patient/family perspective (TM: €2,295.91 [CI: 0.00 to 4,843.28] vs. CM: €430.39 [CI: 0.00 to 4,841.48]), although these large differences-mainly due to a few patients being hospitalized in the TM group, as opposed to none in the CM group-did not reach statistical significance. The Incremental Cost-Effectiveness Ratio (ICER) from the Norwegian NHS perspective (€53,345.27/QALY) and including the patient/caregiver perspective (€55,046.40/QALY), as well as the Incremental Net Benefit (INB), favors the CM alternative, albeit with very broad 95%CIs. The probabilistic analysis confirmed inconclusive results due to the wide CIs even suggesting that TM was not cost-effective in this study. Supplemental analysis excluding the hospitalization costs shows positive INBs, whereby suggesting a discrete superiority of the RM alternative if hospitalization costs were not considered, albeit also with broad CIs., Conclusions: Cost-utility analysis of TM vs. CM shows inconclusive results because of broad confidence intervals with ICER and INB figures ranging from potential savings to high costs for an additional QALY, with the majority of ICERs being above the usual NHS thresholds for coverage decisions., Trial Registration: ClinicalTrials.gov NCT02237404., Competing Interests: The authors have declared that no competing interests exist.

Background: The Micra transcatheter pacing system (TPS) is a miniaturized, single-chamber pacemaker system. Study reported herein is an initial experience with implantation of the Micra TPS., Methods: The leadless pacemaker was implanted in 10 patients with standard indications for a permanent pacemaker implantation. All hospitalization costs were calculated for all patients., Results: The mean age of the patients was 75 ± 7.1 years, 6 were men and 4 were women. Four patients had permanent atrial fibrillation as the basal rhythm and 6 patients had sinus rhythm. All patients had at least one relative contraindication that precluded the use of a traditional pacing system. Mean intraoperative ventricular sensing amplitude was 10.6 ± 5.4 mV, impedance 843 ± 185 ohms, and pacing threshold at 0.24 ms was 0.56 ± 0.23 V. At discharge, those values were 13.9 ± 5.6 mV, 667 ± 119 ohms and 0.47 ± 0.17, respectively. The mean duration of implantation procedure was 82 min, while mean fluoroscopy time was 3.5 min. Two patients developed hematoma at the groin puncture site post-implantation. In 1 case there was a need for erythrocyte mass transfusion and surgical intervention. Mean total time of hospitalization was 26 days and time from procedure to discharge 12 days. Average cost of hospitalization per 1 patient was 11,260.15 EUR minimal cost was 9,052.68 EUR, while maximal cost was 16,533.18 EUR., Conclusions: Implantation of leadless pacemakers is feasible, safe and provides advantages over the conventional system. Hospitalization costs vary for individual patients in wide range.

Objectives: This study investigated whether left ventricular (LV) stimulation via a guidewire-reduced procedure duration while maintaining efficacy and safety compared with standard right ventricular (RV) stimulation., Background: Rapid ventricular pacing is necessary to ensure cardiac standstill during transcatheter aortic valve replacement (TAVR)., Methods: This is a prospective, multicenter, single-blinded, superiority, randomized controlled trial. Patients undergoing transfemoral TAVR with a SAPIEN valve (Edwards Lifesciences, Irvine, California) were allocated to LV or RV stimulation. The primary endpoint was procedure duration. Secondary endpoints included efficacy, safety, and cost at 30 days., Results: Between May 2017 and May 2018, 307 patients were randomized, but 4 were excluded because they did not receive the intended treatment: 303 patients were analyzed in the LV (n = 151) or RV (n = 152) stimulation groups. Mean procedure duration was significantly shorter in the LV stimulation group (48.4 ± 16.9 min vs. 55.6 ± 26.9 min; p = 0.0013), with a difference of -0.12 (95% confidence interval: -0.20 to -0.05) in the log-transformed procedure duration (p = 0.0012). Effective stimulation was similar in the LV and RV stimulation groups: 124 (84.9%) versus 128 (87.1%) (p = 0.60). Safety of stimulation was also similar in the LV and RV stimulation groups: procedural success occurred in 151 (100%) versus 151 (99.3%) patients (p = 0.99); 30-day MACE-TAVR (major adverse cardiovascular event-transcatheter aortic valve replacement) occurred in 21 (13.9%) versus 26 (17.1%) patients (p = 0.44); fluoroscopy time (min) was lower in the LV stimulation group (13.48 ± 5.98 vs. 14.60 ± 5.59; p = 0.02), as was cost (€18,807 ± 1,318 vs. €19,437 ± 2,318; p = 0.001)., Conclusions: Compared with RV stimulation, LV stimulation during TAVR was associated with significantly reduced procedure duration, fluoroscopy time, and cost, with similar efficacy and safety. (Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVR [EASY TAVI]; NCT02781896)., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: The objective of this paper is to assess whether cardiac contractility modulation (via the Optimizer System) plus standard of care (SoC) is a cost-effective treatment for people with heart failure [New York Heart Association (NYHA) III, left ventricular ejection fraction of 25-45%, and narrow QRS] compared against SoC alone from the perspective of the English National Health Service., Methods and Results: We developed a regression equation-based cost-effectiveness model, using individual patient data from three randomized control trials (FIX-HF-5 Phases 1 and 2, and FIX-HF-5C) to populate the majority of parameters. A series of regression equations predicted NYHA class over time, mortality, all-cause hospitalization rates, and health-related quality of life. We conducted the analysis in line with the National Institute for Health and Care Excellence reference case, modelling costs from an English National Health Service perspective, and considering outcomes in quality-adjusted life years (QALYs) over a patient lifetime perspective. Our base case analysis produced an incremental cost per additional QALY of GBP22 988 (€25 750) when comparing Optimizer + SoC to SoC alone. This result was not sensitive to parameter uncertainty but was sensitive to the time horizon over which costs and QALYs were captured and the duration over which a survival benefit with Optimizer + SoC can be assumed to apply., Conclusions: Cardiac contractility modulation is likely to be cost-effective in people with heart failure with reduced ejection fraction, NYHA III, and narrow QRS, provided that the treatment benefit can be maintained beyond the duration of the existing clinical trial follow-up. This analysis supports the current recommendations of the European Society of Cardiology that this therapy may be considered for such patients., (© 2020 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.)

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.

Aims: The aim of this survey was to assess the management and organization of cardiac implantable electronic device (CIED) replacement in Italy., Methods: A questionnaire consisting of 24 questions on organizational aspects and on the peri-procedural management of anticoagulant therapies and antibiotic prophylaxis was sent via the Internet to 154 Italian arrhythmia centers., Results: A total of 103 out of 154 centers completed the questionnaire (67% response rate). In 43% of the centers, the procedures were performed under day-case admission, in 40% under ordinary admission, and in 17% under either day-case or ordinary admission. The most frequent reason (66%) for choosing ordinary admission rather than day-case admission was to obtain full reimbursement. Although warfarin therapy was continued in 73% of the centers, nonvitamin K oral anticoagulants were discontinued, without bridging, 24 h or less prior to replacement procedures in 88%. Prophylactic antibiotic therapy was systematically administered in all centers; in 97%, the first antibiotic dose was administered 1-2 h prior to procedures. Local antibacterial envelopes were also used in 43% of the centers in patients with a higher risk of device infection., Conclusion: This survey provides a representative picture of how CIED replacements are organized and managed in current Italian clinical practice. The choice of the type of hospitalization (short versus ordinary) was more often motivated by economic reasons (reimbursement of the procedure) than by clinical and organizational factors. Peri-procedural management of anticoagulation and prophylactic antibiotic therapy was consistent with current scientific evidence.

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.

Introduction: Few studies have confirmed the cost-saving of telemonitoring of users with pacemakers (PMs). The purpose of this controlled, non-randomised, non-masked clinical trial was to perform an economic assessment of telemonitoring (TM) of users with PMs and check whether TM offers a cost-utility alternative to conventional follow-up in hospital., Methods: Eighty-two patients implanted with an internet-based transmission PM were selected to receive either conventional follow-up in hospital ( n = 52) or TM ( n = 30) from their homes. The data were collected during 12 months while patients were being monitored. The economic assessment of the PONIENTE study was performed as per the perspectives of National Health Service (NHS) and patients. A cost-utility analysis was conducted to measure whether the TM of patients with PMs is cost-effective in terms of costs per gained quality-adjusted life years (QALYs)., Results: There was a significant cost-saving for participants in the TM group in comparison with the participants in the conventional follow-up group. From the NHS's perspective, the patients in the TM group gained 0.09 QALYs more than the patients in the conventional follow-up group over 12 months, with a cost saving of 57.64% (€46.51 versus €109.79, respectively; p < 0.001) per participant per year. In-office visits were reduced by 52.49% in the TM group. The costs related to the patient perspective were lower in the TM group than in the conventional follow-up group (€31.82 versus €73.48, respectively; p < 0.005). The costs per QALY were 61.68% higher in the in-office monitoring group., Discussion: The cost-utility analysis performed in the PONIENTE study showed that the TM of users with PMs appears to be a significant cost-effective alternative to conventional follow-up in hospital.

Aims: Transvenous lead extraction is challenging, often requiring specialist equipment and prolonged hospital admission. A single tariff or itemized costs may be available for reimbursement. Due to limited data relating to the costs of transvenous extraction, it is unclear whether either form of reimbursement is adequate. We aim to describe accurately the total real-world costs of managing patients undergoing transvenous extraction at a single, large centre. We further aim to consider the additional costs of device reimplantation., Methods and Results: At a single UK extraction centre, a retrospective, patient level service line analysis was undertaken, during a complete financial year. Seventy-four patients required transvenous extraction (47 infected and 27 non-infected; 156 leads). Sixty-nine procedures (93%) were performed under general anaesthesia, with a median time in theatre of 95 min [interquartile range (IQR) 71-120]. Specialist extraction tools were required for 130 leads (83%). The median hospitalization duration was 3 days (IQR 1-8). The mean cost of extraction was £9228 (±4099); infected £10 727 (±4178) and non-infected £6619 (±2269). With the additional costs of device reimplantation, the overall mean cost rose to £17 574 (±12 882); infected £22 615 (±13 343) and non-infected £8801 (±5007). At the time of this study, the UK NHS tariff was £2530 for elective and £4764 for non-elective extraction, covering barely half of the real costs., Conclusion: We demonstrated a substantial difference between the real-world cost of extraction and the UK NHS tariff. Extracting centres should scrutinize their practice, including the timing of reimplantation.

Aims: This study assessed the contemporary occurrence of cardiac device infections (CDIs) following implantation in French hospitals and estimated associated costs., Methods and Results: A retrospective analysis was conducted on the French National Hospital Database (PMSI). Patients with a record of de novo cardiac implantable electronic device (CIED) implantation or replacement interventions in France in 2012 were identified and followed until the end of 2015. Cardiac device infections (CDIs) were identified based on coding using the French classification for procedures [Classification Commune des Actes Médicaux (CCAM)] and International Classification of Diseases (ICD-10). Associated costs were estimated based on direct costs from the perspective of the French social security system. In total 78 267 CIED patients (72% de novo implants) were identified (15% defibrillators; 84% pacemakers). The 36-month infection rate associated with de novo defibrillator-only implants, as well as for cardiac resynchronisation therapy - defibrillators (CRT-Ds) was 1.6%. The CDI risk was 2.9% and 3.9% for replacement ICDs and CRT-Ds. Infection rates were lower for de novo single-chamber pacemaker (SCP)/dual-chamber pacemaker (DCP) (0.5%) and cardiac resynchronisation therapy - pacemaker (CRT-P) implants (1.0%), while for replacement procedures the risk increased to 1.4% (SCP/DCP) and 1.3% (CRT-P). Mean infection-related costs over 24 months were €20 623 and €23 234 for CDIs associated with replacement and de novo procedures, and overall costs were not significantly different between pacemaker and defibrillator patients., Conclusion: Cardiac device infections in France are associated with substantial costs, when considering inpatient hospitalizations. Strategies to minimize the rate of CIED infection should be a priority for health care providers and payers.

Background: Under usual care, people with an implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy with or without a defibrillator (CRT-D and CRT-P, respectively), or a permanent pacemaker have follow-up in-person clinic visits. Remote monitoring of these devices allows the transfer of the information stored in the device so that it can be accessed by the clinic personnel via a secured website., Methods: We completed a health technology assessment, which included an evaluation of clinical benefits and harms, value for money, and patient preferences for remote monitoring of ICDs, CRTs, and permanent pacemakers plus clinic visits compared with clinic visits alone. This is an update of a 2012 health technology assessment. In addition to the eligible randomized controlled trials (RCTs) from the 2012 publication, we included RCTs identified through a systematic literature search on June 1, 2017. We assessed the risk of bias of each study using the Cochrane risk of bias tool and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We conducted an economic evaluation to determine the cost-effectiveness of remote monitoring blended with in-clinic follow-up compared to in-clinic follow-up alone in patients with an ICD, a CRT-D, or a pacemaker. We determined the budget impact of blended remote monitoring in patients implanted with ICD, CRT-D, CRT-P, or pacemaker devices from the perspective of the Ontario Ministry of Health and Long-Term Care. To understand patient experiences with remote monitoring, we interviewed 16 patients and family members., Results: Based on 15 RCTs in patients with implanted ICDs or CRT-Ds, remote monitoring plus clinic visits resulted in fewer patients with inappropriate ICD shocks within 12 to 37 months of follow-up (moderate quality evidence; absolute risk difference -0.04 [95% confidence interval -0.07 to -0.01]), fewer total clinic visits (moderate quality evidence), and a shorter time to detection and treatment of events (moderate quality evidence) compared with clinic visits alone. There was a similar risk of major adverse events (moderate quality evidence).Based on 6 RCTs in patients with pacemakers, remote monitoring plus clinic visits reduced the arrhythmia burden (high quality evidence), the time to detection and treatment of arrhythmias (high quality evidence), and the number of clinic visits (moderate quality evidence]) compared with clinic visits alone. Here again, there was a similar risk of major adverse events (high quality evidence).Results from the economic evaluation showed that among ICD and CRT-D recipients, blended remote monitoring (remote monitoring plus in-clinic follow ups) was more costly (incremental value of $4,354 per person) and more effective, providing higher quality-adjusted life years (incremental value of 0.19), compared to in-clinic follow-up alone. Among pacemaker recipients, blended remote monitoring was less costly (with an incremental saving of $2,370 per person) and more effective (with an incremental value of 0.12 quality-adjusted life years) than with in-clinic follow-up alone. We estimated that publicly funding remote monitoring could result in cost savings of $14 million over the first five years.Participants using remote monitoring reported that these devices provide important medical and safety benefits in managing their heart condition. Remote cardiac monitoring provides patients and their family members with an increased freedom. Their belief that the device will help with earlier detection of technical or clinical problems reduces the amount of stress and distraction their condition causes in their lives., Conclusions: Remote monitoring of ICDs, CRT-Ds, and pacemakers plus clinic visits resulted in improved outcomes without increasing the risk of major adverse events compared with clinic visits alone. Remote monitoring is a cost-effective option for patients implanted with cardiac electronic devices. Patients reported positive experiences using remote monitoring, and perceived that the device provided important medical and safety benefits.

Background: Infections of cardiac implantable electronic devices (CIED) are associated with significant morbidity and mortality. Despite many preventive measures, this condition is associated with significant costs for the health care system., Methods: We retrospectively analyzed all infection cases referred for lead extraction at a single university hospital over 1 year (2015-2016). We then calculated all costs related to the infection episode per patient using hospital databases and charts review., Results: Thirty-eight patients with CIED infections (29% women-mean age 71 ± 14 years) were referred for lead extraction (27 pocket infections, 11 endocarditis). Devices were mainly pacemakers (60%). When the pathogen was identified, Staphylococcus aureus methicillin sensitive was the main cause. Extraction was performed in all but 3 cases (92%). One death occurred in the nonextracted group. Respective durations of hospitalization and intravenous and antibiotic administration for patients undergoing extraction were 21 and 36 days. The calculated mean total cost for CIED infection management was CAD$29,907 (median: 26,879; range: CAD$4,827-$62,585). Mean hospital charges were CAD$12,291, accounting for 41% of the total costs., Conclusions: This study represents the first analysis of the direct costs associated with lead extraction in Canada. Device infections are associated with significant costs and increased morbidity. Any preventive measure will have a significant impact on the economic burden of the health care system and patient outcome after lead extraction., (Copyright © 2018 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Importance: The literature is inconsistent regarding the impact of permanent pacemaker implantation after transcatheter aortic valve replacement., Objective: To evaluate clinical and economic outcomes in patients who required permanent pacemaker implantation during the index hospitalization after transcatheter aortic valve replacement., Design, Setting, and Participants: This retrospective, population-based cohort study using data from a multicenter registry included patients who underwent a transcatheter aortic valve replacement procedure from April 1, 2010, to March 31, 2015, in Ontario, Canada, with follow-up to March 31, 2017. Patients who had a previously implanted permanent pacemaker or who died during the index hospitalization were excluded. Inverse probability of treatment weighting using the propensity score was used to adjust for baseline differences between the pacemaker and nonpacemaker groups., Exposures: Patients received a permanent pacemaker during the index hospitalization after transcatheter aortic valve replacement., Main Outcomes and Measures: All-cause mortality, readmission, readmission for heart failure, emergency department visits, and cumulative 1-year health care costs., Results: The study cohort consisted of 1263 patients (mean [SD] age, 82.3 [7.2] years; 595 [47.1%] female; 137 [10.8%] rural), of whom 186 (14.7%) required permanent pacemaker insertion during the index hospitalization after transcatheter aortic valve replacement. Mean follow-up was 990 days. After propensity score weighting, over the entire follow-up period, pacemaker implantation was associated with significantly higher all-cause mortality (43.9% vs 31.7%; hazard ratio [HR], 1.40; 95% CI, 1.01-1.94; P = .04), all-cause readmission (80.9% vs 70.6%; HR, 1.28; 95% CI, 1.15-1.43; P < .001), and emergency department visits (95.5% vs 87.3%; HR, 1.28; 95% CI, 1.08-1.52; P = .004). Pacemaker implantation was also associated with significantly greater readmission for heart failure (33.9% vs 19.1%; HR, 1.90; 95% CI, 1.53-2.36; P < .001). There were no statistically significant differences between groups in adjusted cumulative health care costs 1 year after discharge., Conclusions and Relevance: New permanent pacemaker implantation after transcatheter aortic valve replacement was associated with significantly greater morbidity and mortality at long-term follow-up. However, this did not translate to a difference in cumulative health care costs after hospital discharge.

Background: This study sought to analyze in-hospital outcomes associated with preexisting and newly implanted permanent pacemaker (PPM) in patients who underwent transcatheter aortic valve replacement (TAVR). PPM implantation following the development of conduction abnormalities is a common adverse event following TAVR. Furthermore, PPM implantation rates are higher in TAVR hospitalizations compared with the surgical alternative, thus we have analyzed the predictors of pacing post-TAVR., Hypothesis: We hypothesize that incidence of arrhythmias are high post-TAVR and have worse adverse outcomes after receiving PPM., Methods: The study population was identified from the National Inpatient Sample database between 2012 and 2014. TAVR population was identified using ICD-9-CM procedure codes 35.05 and 35.06. Hospitalizations were divided into 3 group: (1) with preexisting PPM, (2) with newly implanted PPM, and (3) without any PPM., Results: Overall, 0.8% of hospitalizations presented with preexisting PPM and 23.7% of hospitalizations received new PPM. The overall incidence of atrial fibrillation was 44.5%, left bundle branch block 8.9%, complete atrioventricular block 9.5%, and right bundle branch block 2.7%. In-hospital mortality was higher in hospitalizations receiving PPM compared with those without (4.9% vs 4.0%; P = 0.05). Length of stay and cost were higher in the group receiving new PPM. Female sex, atrial fibrillation, left bundle branch block, and second-degree and complete atrioventricular block were significant predictors for receiving PPM after TAVR., Conclusions: A risk stratification for hospitalizations with conduction disorders is necessary to avoid longer hospital stays, added costs, and mortality. Further research is warranted to investigate additional predictors for PPM after TAVR., (© 2018 Wiley Periodicals, Inc.)

Purpose: The purpose of the current study is to characterize and quantify the impact of complete atrioventricular block (cAVB) on heart failure hospitalization (HFH) and healthcare utilization in pacemaker (PM) patients., Methods: Patients ≥ 18 years implanted with a dual-chamber PM from April 2008 to March 2014 were selected from the MarketScan® Commercial and Medicare Supplemental claims databases. Patients with ≤ 1-year continuous MarketScan enrollment prior to and post-implant, and those with prior HF diagnosis were excluded. Patients were dichotomized into those with cAVB, defined as a 3rd degree AVB diagnosis or AV node ablation in the year prior to PM implant, versus those without any AVB (noAVB). Post-implant HFH and associated costs were compared based on inpatient claims., Results: The study cohort included 21,202 patients, of which 14,208 had no AVB and 6994 had cAVB, followed for 2.39 and 2.27 years, respectively. Patients with cAVB were associated with a significantly increased risk of cumulative HFH (HR 1.59 [95% CI 1.35-1.86] p < 0.001) and significantly higher costs ($636 [609-697] vs $369 [353-405] per pt-year, p < 0.001) compared to those with no AVB., Conclusions: Among dual-chamber PM patients without prior HF, cAVB is associated with a significantly increased risk of HFH and greater HF-related healthcare utilization. Identifying patients at high risk for HF in the setting of RV pacing, and potentially earlier use of biventricular or selective conduction system pacing, may reduce HF-related healthcare utilization.

Introduction: Intra-operative complications like mechanical damages to the leads, infections and hematomas during generator replacements of implantable pacemakers and defibrillators contribute to additional costs for hospitals. The aim of this study was to evaluate operation room use, costs and budget impact of generator replacements using either a traditional surgical intervention (TSI) with scissors, scalpel and electrocautery vs. a new radiofrequency energy based surgical system, called PEAK PlasmaBladeTM (PPB)., Materials and Methods: We conducted a retrospective analysis of a population including 508 patients with TSI and 254 patients with PPB who underwent generator replacement at the Kepler University Hospital in Linz or the St. Josef Hospital in Braunau, Austria. The economic analysis included costs of resources used for intra-operative complications (lead damages) and of procedure time for TSI vs. PPB., Results: Proportion of males, mean age and type of generator replaced were similar between the two groups. Lead damages occurred significantly more frequent with TSI than with PPB (5.3% and 0.4%; p< 0.001) and the procedure time was significantly longer with TSI than with PPB (47.9±24.9 and 34.1±18.1 minutes; p<0.001). Shorter procedure time and a lower rate of lead damages with PPB resulted in per patient cost savings of €81. Based on estimated 2,700 patients annually undergoing generator replacement in Austria, the use of PPB may translate into cost savings of €219,600 and 621 saved operating facility hours., Conclusion: PPB has the potential to minimize the risk of lead damage with more efficient utilization of the operating room. Along with cost savings and improved quality of care, hospitals may use the saved operating room hours to increase the number of daily surgeries.

Objectives: The aim of this study was to retrospectively characterize transvenous pacemaker (TVP) complications and associated health care costs in a large-scale U.S. patient cohort., Background: TVP complications have previously been shown to affect more than 1 in 10 patients but may be underestimated. Pacemakers are widely implanted across community and urban hospitals by operators of varying specialization and experience., Methods: Truven Health MarketScan databases track U.S. health care claims and encounters of private or Medicare supplemental insurance. Patients implanted with de dual- and single-chamber TVPs between April 2010 and March 2014 and over 1 year of pre-implantation MarketScan enrollment were identified. International Classification of Diseases-Ninth Revision and Current Procedural Terminology codes were used to extract relevant comorbidities and complications. Incremental adjusted cost analysis was performed for acute complications, defined as those occurring within 30 days of implantation., Results: Among 72,701 TVP implantations (mean age 75 ± 12 years, 55% men, 13% single chamber) with 1.5 ± 1.1 years of follow-up, acute complications (0 to 1 month) occurred in 7.7% of single- and 9.1% of dual-chamber TVPs and long-term complications (1 to 36 months) in 6.4% and 5.9% of single- and dual-chamber TVPs, respectively. The net 3-year event rates were approximately 15% and 16%. The incidence and incremental cost of complications are considerable. Most common acute complications include thoracic trauma (3.71%, $70,114), leads requiring revision (3.51%, $9,296), and infection (1.15%, $80,247). Long-term complications are attributed to leads (2.84%), infection (2.42%), and pocket (0.96%)., Conclusions: Claims data suggest that TVP complications are more common than previously reported, affecting nearly 1 in 6 patients by 3 years and contributing to considerable incremental U.S. health care cost., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The Home Monitoring (HM) system of cardiac implantable electronic devices (CIEDs) permits early detection of arrhythmias or device system failures. The aim of this pilot study was to examine how the safety and efficacy of the HM system in patients after ambulatory implanted primary CIEDs compare to patients with a standard procedure and hospitalization., Hypothesis: We hypothesized that HM and their modifications would be a useful extension of the present concepts for ambulatory implanted CIEDs., Methods: This retrospective analysis evaluates telemetric data obtained from 364 patients in an ambulatory single center over 6 years. Patients were assigned to an active group (n = 217), consisting of those who were discharged early on the day of implantation of the primary CIED, or to a control group (n = 147), consisting of those discharged and followed up with the HM system according to usual medical practices., Results: The mean duration of hospitalization was 73.2% shorter in the active group than in the control group, corresponding to 20.5 ± 13 fewer hours (95% confidence interval [CI]: 6.3-29.5; P < 0.01) spent in the hospital (7.5 ± 1.5 vs 28 ± 4.5 h). This shorter mean hospital stay was attributable to a 78.8% shorter postoperative period in the active group. The proportion of patients with treatment-related adverse events was 11% (n = 23) in the active group and 17% (n = 25) in the control group (95% CI: 5.5-8.3; P = 0.061). This 6% absolute risk reduction (95% CI: 3.3-9.1; P = 0.789) confirmed the noninferiority of the ambulatory implanted CIED when compared with standard management of these patients., Conclusions: Early discharge with the HM system after ambulatory CIED implantation was safe and not inferior to the classic medical procedure. Thus, together with lower costs, HM and its modifications would be a useful extension of the present concepts for ambulatory implanted CIEDs., (© 2017 Wiley Periodicals, Inc.)

Background: Although studies assessing the cost effectiveness of genotype-guided warfarin dosing for the management of atrial fibrillation, deep vein thrombosis, and pulmonary embolism have been reported, no publications have addressed genotype-guided warfarin therapy in mechanical heart valve replacement (MHVR) patients or genotype-guided warfarin therapy under the fee-for-service (FFS) insurance system., Objective: The aim of this study was to evaluate the cost effectiveness of genotype-guided warfarin dosing in patients with MHVR under the FFS system from the Korea healthcare sector perspective., Methods: A decision-analytic Markov model was developed to evaluate the cost effectiveness of genotype-guided warfarin dosing compared with standard dosing. Estimates of clinical adverse event rates and health state utilities were derived from the published literature. The outcome measure was the incremental cost-effectiveness ratio (ICER) per quality-adjusted life-year (QALY). One-way and probabilistic sensitivity analyses were performed to explore the range of plausible results., Results: In a base-case analysis, genotype-guided warfarin dosing was associated with marginally higher QALYs than standard warfarin dosing (6.088 vs. 6.083, respectively), at a slightly higher cost (US$6.8) (year 2016 values). The ICER was US$1356.2 per QALY gained. In probabilistic sensitivity analysis, there was an 82.7% probability that genotype-guided dosing was dominant compared with standard dosing, and a 99.8% probability that it was cost effective at a willingness-to-pay threshold of US$50,000 per QALY gained., Conclusion: Compared with only standard warfarin therapy, genotype-guided warfarin dosing was cost effective in MHVR patients under the FFS insurance system.

Background: Implantation of cardiac implanted electronic device (CIED) has surged lately. This resulted in a rise in cardiac device-related infections (CDI) and inevitably, lead extractions. We examined the recent national trend in the incidence of CIED infections and lead extractions in hospitalized patients and associated mortality., Methods: Using the Nationwide Inpatient Sample for the years 2003-2011 we identified patients diagnosed with a CDI-associated infection as determined by discharge ICD-9 diagnostic codes. We examined the trend of device-related infections overall and in different subgroups. We studied mortality associated with device infections, lead extractions, associated costs, and length of stay., Results: There is a significant increase in the number of hospitalizations due to CDI from 5,308 in the year 2003 to 9,948 in 2011. Males (68%), Caucasians (77%), and age group 65-84 years (56.4%) accounted for majority of CDI. The mortality associated with CDI was 4.5 %, and was worse in higher age groups (2.5% in 18-44 years compared to 5.3% in 85+ years, P < 0.001). Average length of stay was unchanged over the years remaining at 13.6 days; however, mean hospitalization charges increased from $91,348 in 2003 to $173,211 in 2011 (P < 0.001). Among all lead extraction procedures, the percentage of patients undergoing lead extraction secondary to CDI also increased from 2003 (59.1%) to 2011 (76.7%), P-value < 0.001., Conclusions: Healthcare burden associated with CDI infections and associated lead extractions has significantly increased in the recent years. Despite an increase in cost associated with CIED infections, mortality remains the same, and is higher in older patients., (© 2017 Wiley Periodicals, Inc.)

Implantable cardiac pacing and defibrillation devices are effective and commonly used therapies for patients with cardiac rhythm disorders. Because device implantation is not easily reversible, as well as the high healthcare costs inherent in device use, a clear understanding of the clinical benefits relative to costs is essential for both appropriate clinical use and rational policy making. Cardiac implantable electronic devices (CIEDs) have been among the best-investigated therapies in medicine; these devices have been the topic of numerous clinical and economic evaluations during the past 30 years. However, many important questions remain unclarified. We review the evidence supporting the clinical benefits of CIEDs, including effectiveness in extending survival as well as improving quality of life. We also summarize the economic studies that have investigated costs associated with these devices and their overall cost effectiveness, and we highlight important potential areas for future research.

Background: Pneumothorax (PTX) is a major cause of morbidity associated with cardiac implantable electronic devices (CIEDs). We sought to evaluate predictors of PTX at our centers during CIED implantations, including the venous access technique utilized, as well as to determine morbidity and costs associated with PTX., Methods: We reviewed records of all patients undergoing cardiac device implant or revision with new venous access at our institutions between 2008 and 2014. Common demographic and procedure characteristics were collected including age, sex, body mass index (BMI), comorbidities, and method of venous access (axillary vein vs classic proximal subclavian vein technique)., Results: We identified 1,264 patients who met criteria for our analysis, with a total of 21 PTX cases during CIED implantation. The strongest predictor for PTX was the venous access strategy: 0 of 385 (0%) patients with axillary vein approach versus 21 of 879 (2.4%) with traditional subclavian vein approach, P = 0.0006. Additional predictors of PTX included advanced age, female sex, low BMI, and a new device implant (vs device upgrade). The occurrence of PTX was associated with increased length of stay: 3.0 days (median; interquartile range [IQR] 3) versus 1.0 day (median; IQR: 1), P = 0.0001, with a cost increase of 361.4%., Conclusion: An axillary vein vascular access strategy was associated with greatly reduced risk of iatrogenic PTX versus the traditional subclavian approach for CIED placement. Similarly, device upgrade with patent vascular access carried less risk of PTX compared to new device implantation. PTX occurrence significantly prolonged hospitalization and increased costs., (© 2016 Wiley Periodicals, Inc.)

With the worldwide shortage of donor organs, use of ventricular assist device (VAD) therapy is rapidly increasing in both the bridge to transplant and destination therapy settings. However, the high cost of VADs and VAD care is a cause for concern for policy makers who have relied on the limited supply of donor hearts to naturally cap health expenditure on heart transplantation (HTx). We sought to compare costs of the first 12 months of care of VADs vs. HTx. Single center retrospective study utilizing real generated costs over a three yr span from 2010-2012. Only patients with 12 months of costing data were included. Costs of 28 HTx patients and 24 VAD patients were analyzed. Index admission costs were more than double in the VAD group compared to the HTx group and this was driven by the procurement costs and length of stay which increased almost all aspects of in hospital care costs. Subsequent costs were six times higher in the HTx group and this was driven largely by pharmaceuticals. VAD therapy remains a very expensive treatment option for end stage heart failure patients. Device prices need to reduce substantially to make this a more widely applicable and cost effective treatment option., (© 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Objectives: The purpose of this study was to assess the burden borne by and the costs to informal caregivers of patients with remotely monitored (RM) pacemakers., Methods: The PONIENTE study was a controlled, non-randomised clinical trial, with data collected from informal caregivers, 12 months after implantation of pacemakers. The survey on disabilities, personal autonomy, and dependency situations was used to gather information on demographic and social characteristics, levels of professionalism, time and types of care, difficulties in providing care, health status, professional aspects, economic and family or leisure impacts due to informal caregiving for patients with pacemakers., Results: During 14 months, 76 caregivers were enrolled in the PONIENTE trial. Of which, 26 were included in the RM group and 50 in the hospital-monitored group (HM). The mean ages were 58.62 ± 16.51 and 61.10 ± 12.67 years, respectively (p = 0.56) in the groups, and 69.7 % were females. The majority (96.1 %) of the caregivers declared that they had to provide their services between 6 and 7 days per week (88.5 % in RM group versus 100 % in HM group; p = 0.037). The costs related to care provided by the informal caregivers were 21.38 % lower in the RM group than in the HM group (p = 0.033)., Conclusions: The PONIENTE study shows a significant impact of informal care on relatives and friends of patients with pacemakers in terms of their well-being and costs., Trial Registration: ClinicalTrials.gov NCT02234245.

Introduction and Objectives: Over the last decade, telemedicine applied to pacemaker monitoring has undergone extraordinary growth. It is not known if telemonitoring is more or less efficient than conventional monitoring. The aim of this study was to carry out a systematic review analyzing the available evidence on resource use and health outcomes in both follow-up modalities., Methods: We searched 11 databases and included studies published up until November 2014. The inclusion criteria were: a) experimental or observational design; b) studies based on complete economic evaluations; c) patients with pacemakers, and d) telemonitoring compared with conventional hospital monitoring., Results: Seven studies met the inclusion criteria, providing information on 2852 patients, with a mean age of 81 years. The main indication for device implantation was atrioventricular block. With telemonitoring, cardiovascular events were detected and treated 2 months earlier than with conventional monitoring, thus reducing length of hospital stay by 34% and reducing routine and emergency hospital visits as well. There were no significant intergroup differences in perceived quality of life or number of adverse events. The cost of telemonitoring was 60% lower than that of conventional hospital monitoring., Conclusions: Compared with conventional monitoring, cardiovascular events were detected earlier and the number or hospitalizations and hospital visits was reduced with pacemaker telemonitoring. In addition, the costs associated with follow-up were lower with telemonitoring., (Copyright © 2015 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Introduction: Cardiac rhythm management devices (CRMDs) have proven their clinical effectiveness for patients with heart rhythm disorders. Little is known about safety and complication rates during the implantation of these devices. This study demonstrated the complication rates related to CRMD implantation, and estimated the additional hospital stay and cost associated with the management of complications., Methods: During a period of one year, a total of 464 consecutive recipients underwent CRMD implantation and were followed for 2 years. Finally, data were analyzed for 398 patients who completed the two-year follow up, resulting in a total of 796 patient-years., Results: Of the 201 patients with initial pacemaker (PM) implantations, 6 (2.99%) had seven complications (5 patients had lead dislodgement, 1 of them twice), and 1 patient developed pocket infection. Of the 117 PM replacements, 1 (0.85%) patient developed a complication (pocket erosion). Two patients with complications (1 with an initial PM and 1 with a replacement) died before completing the follow up for reasons unrelated to cardiac causes. There were no complications in either initial implantations (69 patients) or replacements (11 patients) of implantable cardioverter-defibrillators. The average prolongation of the hospital stay was 7 days, ranging from 1 to 35 days, resulting in 17,411 of total additional direct hospital costs., Conclusion: This study found relatively low rates of complications in patients undergoing CRMD implantation, initial or replacement, in our center, compared with other studies. The additional hospitalization days and costs attributable to these complications depend on the nature of the complication.

The number of device implantations is in constant increase due to the ageing population, extended indications to implant for preventing sudden cardiac death and treating heart failure. An increase in the number of implants is directly related to a higher number of device replacements and that is one of the most important risk factors for device infection. Therefore, all the above mentioned factors contribute to an increase in the cost for health care system. Currently, several methods help to prolong device battery longevity and consequently reduce the costs, such as: a new battery, drug eluting leads, high impedance leads, algorithm to minimize unnecessary pacing, capture management and correct programming to avoid inappropriate and unnecessary shock in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy devices. Furthermore remote monitoring is very promising to reduce health system costs related to devices.