Factors Associated with the Treatment Costs within the First Year after Pacemaker Implantation or Pulse Generator Replacement. / Fatores Associados aos Custos do Tratamento no Primeiro Ano após Implantes Iniciais ou Trocas de Geradores de Pulsos de Marca-passos Cardíacos.

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.

FUNDAMENTO: O uso de marca-passos cardíacos artificiais tem crescido constantemente, acompanhando o envelhecimento populacional. OBJETIVOS: Determinar as taxas de readmissões hospitalares e complicações após implante de marca-passo ou troca de gerador de pulsos e avaliar o impacto desses eventos nos custos anuais do tratamento sob a perspectiva do Sistema Único de Saúde (SUS). MÉTODOS: Registro prospectivo, com dados derivados da prática clínica assistencial, coletados na hospitalização índice e durante os primeiros 12 meses após o procedimento cirúrgico. O custo da hospitalização índice, do procedimento e do seguimento clínico foram estimados de acordo com os valores reembolsados pelo SUS e analisados ao nível do paciente. Modelos lineares generalizados foram utilizados para estudar fatores associados ao custo total anual do tratamento, adotando-se um nível de significância de 5%. RESULTADOS: No total, 1.223 pacientes consecutivos foram submetidos a implante inicial (n= 634) ou troca do gerador de pulsos (n= 589). Foram observados 70 episódios de complicação em 63 pacientes (5,1%). A incidência de readmissões hospitalares em um ano foi de 16,4% (IC 95% 13,7% - 19,6%) após implantes iniciais e 10,6% (IC 95% 8,3% - 13,4%) após trocas de geradores. Doença renal crônica, histórico de acidente vascular encefálico, tempo de permanência hospitalar, necessidade de cuidados intensivos pós-operatórios, complicações e readmissões hospitalares mostraram um impacto significativo sobre o custo anual total do tratamento. CONCLUSÕES: Os resultados confirmam a influência da idade, comorbidades, complicações pós-operatórias e readmissões hospitalares como fatores associados ao incremento do custo total anual do tratamento de pacientes com marca-passo.

Economic Considerations of Cardiovascular Implantable Electronic Devices for The Treatment of Heart Failure.

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.

A Real-World Comparison of 1-Year Survival and Expenditures for Transcatheter Aortic Valve Replacements: SAPIEN 3 Versus CoreValve Versus Evolut R.

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.

Trends in the use, complications, and costs of permanent pacemakers in Australia: A nationwide study from 2008 to 2017.

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.

Early Versus Delayed Pacemaker for Heart Block After Valve Surgery: A Cost-Effectiveness Analysis.

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.

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.

Trends in utilization and spending on remote monitoring of pacemakers and implantable cardioverter-defibrillators among Medicare beneficiaries.

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.

Impact of Cardiac Implantable Electronic Device Infection: A Clinical and Economic Analysis of the WRAP-IT Trial.

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.

Costs and complications associated with transvenous lead reoperation in cardiac implantable electronic devices.

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.

Cost-utility analysis of telemonitoring versus conventional hospital-based follow-up of patients with pacemakers. The NORDLAND randomized clinical trial.

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.

A randomized trial evaluating the accuracy of AF detection by four external ambulatory ECG monitors compared to permanent pacemaker AF detection.

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.

The predictors and economic burden of early-, mid- and late-onset cardiac implantable electronic device infections: a retrospective cohort study in Ontario, Canada.

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.

Implantation of the Micra transcatheter pacing system: Single Polish center experience with the real costs of hospitalization analysis.

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.

Cost and Outcomes of Implantable Cardiac Electronic Device Infections in Victoria, Australia.

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.

Left Ventricular Rapid Pacing Via the Valve Delivery Guidewire in Transcatheter Aortic Valve Replacement.

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).

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.

Clinical and organizational management of cardiac implantable electronic device replacements: an Italian Survey promoted by AIAC (Italian Association of Arrhythmology and Cardiac Pacing).

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.

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.