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

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

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

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

Economics of Home Monitoring for Apnea in Late Preterm Infants.

BACKGROUND: Apnea of prematurity affects a small proportion but large absolute number of late preterm infants, with out-patient management variably utilized despite relative clinical equipoise and potential for improved cost-effectiveness. METHODS: Over a 5-y period, from 2009 to 2013, infants born at ≥34 weeks gestational age at a level IIIB academic center in Boston, Massachusetts, with discharge-delaying apnea, bradycardia, and desaturation (ABD) events were identified. In-patient costs for discharge-delaying ABD events were compared with hypothetical out-patient management. Out-patient costs took into account 4-10 d of in-patient observation for ABD events before caffeine initiation, 3-5 d of additional in-patient observation before discharge, daily caffeine until 43 weeks corrected gestational age, home pulse oximetry monitoring until 44 weeks corrected gestational age, and consideration of variable readmission rates ranging from 0 to 10%. RESULTS: A total of 425 late preterm and term infants were included in our analysis. Utilization of hypothetical out-patient management resulted in cost savings per eligible patient ranging from $2,422 to $62, dependent upon variable periods of in-patient observation. Sensitivity analysis demonstrated few instances of decreased relative cost-effectiveness. CONCLUSIONS: Out-patient management of discharge-delaying ABD events in a late preterm and term population was a cost-effective alternative to prolonged in-patient observation.

Effects of enhanced pacing modalities on health care resource utilization and costs in bradycardia patients: An analysis of the randomized MINERVA trial.

BACKGROUND: Many patients who suffer from bradycardia and need cardiac pacing also have atrial fibrillation (AF). New pacemaker algorithms, such as atrial preventive pacing and atrial antitachycardia pacing (DDDRP) and managed ventricular pacing (MVP), have been specifically designed to reduce AF occurrence and duration and to minimize the detrimental effects of right ventricular pacing. The randomized MINimizE Right Ventricular pacing to prevent Atrial fibrillation and heart failure trial established that DDDRP + MVP pacing modality reduced permanent AF in bradycardia patients as compared with standard dual-chamber pacing (DDDR). OBJECTIVE: The aim of this study was to estimate the cost savings due to lower AF-related health care utilization events based on health care costs from the United States and the European Union. METHODS: Dual-chamber pacemaker patients with a history of paroxysmal or persistent AF were randomly assigned to receive DDDR (n = 385) or the advanced features (DDDRP + MVP; n = 383). We used published health care costs from the United States and the European Union (Italy, Spain, and the United Kingdom) to estimate the costs associated with AF-related hospitalizations and emergency visits. RESULTS: The rate of AF-related hospitalizations was significantly lower in the DDDRP + MVP group than in the conventional pacemaker group (DDDR group; 42% reduction; incidence rate ratio 0.58). Similarly, a significant reduction of 68% was observed for AF-related emergency department visits (incidence rate ratio 0.32; P < .001). As a consequence, DDDRP + MVP could potentially reduce health care costs by 40%-44%. Over a ten-year period, the cost savings per 100 patients ranged from $35,702 in the United Kingdom to $121,831 in the United States. CONCLUSION: New pacing algorithms such as DDDRP + MVP used in the MINimizE Right Ventricular pacing to prevent Atrial fibrillation and heart failure trial successfully reduced AF-related health care utilization, resulting in significant cost savings to payers.

Implantation trends and patient profiles for pacemakers and implantable cardioverter defibrillators in the United States: 1993-2006.

BACKGROUND: Prior studies of cardiac rhythm management devices (pacemakers [PM] and implantable cardioverter defibrillators [ICD]) utilization in the United States have been limited to the Medicare population. We evaluated the national trends for the implantation of PMs and ICDs including the burden of device replacement. METHODS: The Nationwide Inpatient Sample was queried to identify PM and ICD patients between 1993 and 2006 using ICD-9-CM codes, including demographics, health profile, and economic data. The Charlson Comorbidity Index (CCI) and replacement burden were calculated, and changes over time studied. RESULTS: From 1993 to 2006, 2.4 million patients received a primary PM and 0.8 million received an ICD, while there were 369,000 PM replacements and 74,000 ICD replacements. Women comprised 49% of PM and 24% of ICD patients. The mean ICD replacement burden was 8.4% (range 5-22%) and decreased significantly over time (P < 0.0001) while the replacement burden for PMs was constant (mean = 13.4%, range 11-16%). ICD patients had more comorbidities than PM patients (CCI: 0.8 vs 1.1, P < 0.0001). CONCLUSIONS: The replacement burden for PMs has remained constant, while the replacement burden for ICDs has decreased. This is likely due to the stability of the patient population receiving PMs and technology maturity. Alternatively, the indications for ICD implantation have broadened, resulting in an increased number of primary ICD implantations. The age and comorbidities are increasing in those patients receiving ICDs while the PM population is stable. These data suggest that monitoring of replacement burden is warranted, given the changing populations, their disparate clinical outcomes, and economic implications to the health care system.

Economic and health consequences of managing bradycardia with dual-chamber compared to single-chamber ventricular pacemakers in Italy.

OBJECTIVE: This study sought to estimate the economic implications of managing bradycardia due to sinoatrial node disease or atrioventricular block with dual compared to single-chamber ventricular pacemakers from an Italian government perspective. Dual-chamber pacemakers lower the risk of developing atrial fibrillation and pacemaker syndrome. METHODS: A discrete event simulation of a patient's course for 5 years following pacemaker implantation. Each patient may experience the following: complications, pacemaker syndrome, atrial fibrillation, stroke, or death. Risk functions were based on published data from the Canadian Trial of Physiologic Pacing and Mode Selection Trial in Sinus-Node Dysfunction. Identical patients were simulated after receiving a single or dual-chamber pacemaker. Quality-adjusted life-years (QALYs) and direct medical costs were estimated (2004 Euros). Benefits and costs were discounted at 3%. RESULTS: The model predicts that implanting the dual-chamber device in 1000 patients will prevent 36 patients from developing atrial fibrillation, 168 from developing severe pacemaker syndrome, but will lead to 13 additional hospitalizations with complications over 5 years. Health benefits are achieved at an incremental cost of 23 euros per patient, and 0.09 QALY, yielding an incremental cost-effectiveness ratio of euro 260 euros/QALY. Sensitivity analysis shows that device replacement rates due to pacemaker syndrome have the biggest impact on the final results. CONCLUSIONS: In the long term, higher initial costs of the dual-chamber device may be offset by a reduction in costs associated with reoperations and atrial fibrillation.

Modelling the health benefits and economic implications of implanting dual-chamber vs. single-chamber ventricular pacemakers in the UK.

AIMS: To estimate the consequences of managing bradycardia due to sinoatrial node disease or atrioventricular block with dual-chamber vs. single-chamber ventricular pacemakers. METHODS AND RESULTS: A discrete-event simulation was conducted to predict outcomes over 5 years. Patients could develop post-operative complications, clinically relevant pacemaker syndrome leading to replacement of single-chamber with dual-chamber, atrial fibrillation (AF; which if chronic might require anticoagulants) or stroke. Survival, quality-adjusted life years (QALYs), complications, and associated direct medical costs were estimated (2003 British Pounds pounds sterling). Identical patients were simulated after receiving a single-chamber device or a more expensive dual-chamber pacemaker. Probabilities of conditions were obtained from clinical trials. Benefits were discounted at 1.5% and costs at 6%. Post-operative complications increased from 6.4% with single-chamber to 7.7% with dual-chamber but AF decreased (22 vs. 18%) as did clinically relevant pacemaker symptoms (16.8 vs. 0%). Approximately 4300 pounds sterling were accrued per patient over 5 years. Additional health benefits with dual-chamber are achieved at a mean net cost of 43 pounds sterling per patient, leading to 0.09 QALY with a cost-effectiveness ratio of 477 pounds sterling/QALY. CONCLUSION: Implanting the costlier device increases the cost of the initial operation; however, this is expected to be offset by a reduction in costs associated with re-operations and AF.

The effectiveness and cost-effectiveness of dual-chamber pacemakers compared with single-chamber pacemakers for bradycardia due to atrioventricular block or sick sinus syndrome: systematic review and economic evaluation.

OBJECTIVES: To estimate the effectiveness and cost-effectiveness of dual-chamber pacemakers versus single-chamber atrial or single-chamber ventricular pacemakers in the treatment of bradycardia due to sick sinus syndrome (SSS) or atrioventricular block (AVB). DATA SOURCES: Electronic databases and relevant Internet sites. Contact with device manufacturers and experts in the field. REVIEW METHODS: A systematic review was carried out of randomised controlled trials (RCTs). The quality of selected studies was appraised using standard frameworks. Meta-analyses, using random effects models, were carried out where appropriate. Limited exploration of heterogeneity was possible. Critical appraisal of economic evaluations was carried out using two frameworks. A decision-analytic model was developed using a Markov approach, to estimate the cost-effectiveness of dual-chamber versus ventricular or atrial pacing over 5 and 10 years as cost per quality-adjusted life-year (QALY). Uncertainty was explored using one-way and probabilistic sensitivity analyses. RESULTS: The searches retrieved a systematic review of effectiveness and cost-effectiveness published in 2002, four parallel group RCTs and 28 cross-over trials. Dual-chamber pacing was associated with lower rates of atrial fibrillation, particularly in SSS, than ventricular pacing, and prevents pacemaker syndrome. Higher rates of atrial fibrillation were seen with dual-chamber pacing than with atrial pacing. Complications occurred more frequently in dual-chamber pacemaker insertion. The cost of a dual-chamber system, over 5 years, including cost of complications and subsequent clinical events in the population, was estimated to be around 7400 pounds. The overall cost difference between single and dual systems is not large over this period: around 700 pounds more for dual-chamber devices. The cost-effectiveness of dual-chamber compared with ventricular pacing was estimated to be around 8500 pounds per QALY in AVB and 9500 pounds in SSS over 5 years, and around 5500 pounds per QALY in both populations over 10 years. Under more conservative assumptions, the cost-effectiveness of dual-chamber pacing is around 30,000 pounds per QALY. The probabilistic sensitivity analysis showed that, under the base-case assumptions, dual-chamber pacing is likely to be considered cost-effective at levels of willingness to pay that are generally considered acceptable by policy makers. In contrast, atrial pacing may be cost-effective compared with dual-chamber pacing. CONCLUSIONS: Dual-chamber pacing results in small but potentially important benefits in populations with SSS and/or AVB compared with ventricular pacemakers. Pacemaker syndrome is a crucial factor in determining cost-effectiveness; however, difficulties in standardising diagnosis and measurement of severity make it difficult to quantify. Dual-chamber pacing is in common usage in the UK. Recipients are more likely to be younger. Insufficient evidence is currently available to inform policy on specific groups who may benefit most from pacing with dual-chamber devices. Further important research is underway. Outstanding research priorities include the economic evaluation of UKPACE studies of the classification, diagnosis and utility associated with pacemaker syndrome and evidence on the effectiveness of pacemakers in children.