Impact of COVID-19 pandemic on the volume, cost, and outcomes of cardiac electrophysiology procedures in the United States.

BACKGROUND: During the COVID-19 pandemic, professional societies recommended deferral of elective procedures for optimal resource utilization. OBJECTIVE: We sought to assess changes in procedural trends and outcomes of electrophysiology (EP) procedures during the pandemic. METHODS: National Inpatient Sample databases were used to identify all EP procedures performed in the United States (2016-2020) by International Classification of Diseases, Tenth Revision codes. We evaluated trends in utilization, cost/revenue, and outcomes from EP procedures performed. RESULTS: An estimated 1.35 million EP procedures (82% devices and 18% catheter ablations) were performed (2016-2020) with significant yearly uptrend. During the pandemic, there was a substantial decline in EP procedure utilization from a 5-year peak of 298 cases/million population in the second quarter of 2019 to a nadir of 220 cases in the second quarter of 2020. In 2020, the pandemic was associated with the loss of 50,233 projected EP procedures (39,337 devices and 10,896 ablations) with subsequent revenue loss of $7.06 billion. This deficit was driven by revenue deficit from dual-chamber permanent pacemaker (PPM) utilization ($2.88 billion, 49.3% of lost cases), ablation procedures ($1.84 billion, 21.7% of lost cases), and implantable cardioverter-defibrillator implantation ($1.36 billion, 12.0% of lost cases). To the contrary, there was a 9.4% increase in the utilization of leadless PPM. EP device implantation during the pandemic was associated with higher adverse in-hospital events (9.4% vs 8.0%; P < .001). CONCLUSION: In the United States, the significant decline in EP procedures during the pandemic was primarily driven by the reduction in dual-chamber PPM utilization, followed by arrhythmia ablation and implantable cardioverter-defibrillator implantation. There was a substantial increase in leadless PPM utilization during the pandemic.

The Safety and Efficacy of Transcatheter Pulmonary Valve Replacement Combined with Electrophysiology Procedures.

The objective of this study was to evaluate the safety and efficacy of combining transcatheter pulmonary valve replacement (TPVR) and electrophysiology (EP) procedures. A retrospective review was undertaken to identify TPVR and EP procedures that were concomitantly performed in the cardiac catheterization laboratory at University of Iowa Stead Family Children's Hospital from January 2011 to October 2019. Procedural and follow-up data were compared between patients who underwent TPVR and EP procedures in the same setting to those who received TPVR or EP procedure separately and that were similar in age and cardiac anatomy. A total of 8 patients underwent combined TPVR and EP procedures. One patient was excluded due to lack of adequate control, leaving seven study subjects (57% female; median age at time of procedure 16 years). The median follow-up time was 11.5 months (range 2-36 months). Patients who received combined TPVR and EP had shorter recovery times (combined: median 18.9 h; IQR 18.35-19.5 vs separate: median 27.98 h; IQR 21.42-39.25; p-value 0.031), shorter hospital length of stay (combined: median 27.5 h; IQR 26.47-31.4 vs separate: median 38.4 h; IQR 33.42-51.50; p-value 0.016), and a 51% reduction in total hospital charges (combined: median $171,640; IQR 135.43-219.22 vs separate: median $333,560 IQR 263.20-400.98; p-value 0.016). There were no significant differences in radiation dose or procedure time between the combined and control groups. The median radiation time for those who had the combination procedure was 30.5 min [IQR 29.6-47.9], and the median dose area product was 215 mGy [IQR 158-935]. In conclusion, combining TPVR and EP procedures is feasible, safe, and economically advantageous.

Cost-effective and multifunctional acquisition system for in vitro electrophysiological investigations with multi-electrode arrays.

In vitro multi-electrode array (MEA) technology is nowadays involved in a wide range of applications beyond neuroscience, such as cardiac electrophysiology and bio-interface studies. However, the cost of commercially available acquisition systems severely limits its adoption outside specialized laboratories with high budget capabilities. Thus, the availability of low-cost methods to acquire signals from MEAs is important to allow research labs worldwide to exploit this technology for an ever-expanding pool of experiments independently from their economic possibilities. Here, we provide a comprehensive toolset to assemble a multifunctional in vitro MEA acquisition system with a total cost 80% lower than standard commercial solutions. We demonstrate the capabilities of this acquisition system by employing it to i) characterize commercial MEA devices by means of electrical impedance measurements ii) record activity from cultures of HL-1 cells extracellularly, and iii) electroporate HL-1 cells through nanostructured MEAs and record intracellular signals.

Cost analysis of combining congenital cardiac catheterization and electrophysiology procedures in an outpatient setting.

BACKGROUND: Patients with congenital heart disease require multiple procedures over their lifetime. These procedures increase cost and time commitment. Previous studies in the field of medicine have shown that combining procedures is an effective method to reduce cost and time. There has been no such study to evaluate the cost and efficiency of combining pediatric cardiac procedures. OBJECTIVE: The objective of this study was to compare the cost and time commitment of combined cardiac catheterization (cath) and electrophysiology (EP) outpatient procedures against separate cath and EP procedure. METHODS: Outpatient combination procedures performed in the pediatric cardiac cath lab from 2013 to 2016 were matched to a control population of two or three similar single outpatient procedures from 2009 to 2016 for patients of similar age and cardiac anatomy. Procedure duration, recovery duration, length of stay, equipment charges, physician charges, all other hospital charges, and total admission charges were analyzed. The two groups were compared using an unpaired t-test. RESULTS: A total of 92 subjects, 32 study subjects and 60 control subjects, were included in this study. Study group procedures had a significantly shorter recovery duration (P = 0.04) and length of stay (P = 0.01). Study group procedure duration trended shorter on average but statistically insignificant (P = 0.20). The total median savings for patients undergoing combined procedures in the study group was $13,181 (interquartile range $423.8-$26710). CONCLUSIONS: Combining cath and EP outpatient procedures reduces the time commitment and provides some economic advantage.

Cost effectiveness of focal impulse and rotor modulation guided ablation added to pulmonary vein isolation for atrial fibrillation.

BACKGROUND: Although ablation with focal impulse and rotor modulation (FIRM), as an adjunct to pulmonary vein isolation (PVI), has been shown to decrease atrial fibrillation (AF) recurrence, cost-effectiveness has not been assessed. OBJECTIVE: We aimed to evaluate the cost effectiveness of FIRM-guided ablation when added to PVI in a mixed AF population. METHODS AND RESULTS: We used a Markov model to estimate the costs, quality-adjusted survival, and cost effectiveness of adding FIRM ablation to PVI. AF recurrence rates were based on 3-year data from the CONFIRM trial. Model inputs for event probabilities and utilities were obtained from literature review. Costs were based on Medicare reimbursement, wholesale acquisition costs, and literature review. Three-year total costs FIRM+PVI versus PVI alone were $27,686 versus $26,924. QALYs were 2.338 versus 2.316, respectively, resulting in an incremental cost-effectiveness ratio (ICER) of $34,452 per QALY gained. Most of the cost (65-81%) was related to the index ablation procedure. Lower AF recurrence generated cost offsets of $4,266, primarily due to a reduced need for medications and repeat ablation. Probabilistic sensitivity analysis demonstrated ICER below $100,000/QALY in 74% of simulations. CONCLUSION: Based on data from the CONFIRM study, the addition of FIRM to PVI does have the potential to be cost-effective due to higher quality-adjusted life years and lower follow-up costs. Value is sensitive to the incremental reduction in AF recurrence, and FIRM may have the greatest economic value in patients with greater AF symptom severity. Results from ongoing randomized trials will provide further clarity.

Ablation of paroxysmal atrial fibrillation using a second-generation cryoballoon catheter or contact-force sensing radiofrequency ablation catheter: A comparison of costs and long-term clinical outcomes.

INTRODUCTION: Although noninferiority of cryoballoon ablation (CBA) and radiofrequency catheter ablation for antral pulmonary vein isolation (APVI) has been reported in patients with paroxysmal atrial fibrillation (PAF), it is not clear whether contact force sensing (CF-RFA) and CBA with the second-generation catheter have similar procedural costs and long-term outcomes. The objective of this study is to compare the long-term efficacy and cost implications of CBA and CF-RFA in patients with PAF. METHODS AND RESULTS: A first APVI was performed in 146 consecutive patients (age: 63 ± 10 years, men: 95 [65%], left atrial diameter: 42 ± 6 mm) with PAF using CBA (71) or CF-RFA (75). Clinical outcomes and procedural costs were compared. The mean procedure time was significantly shorter with CBA than with CF-RFA (98 ± 39 vs. 158 ± 47 minutes, P < 0.0001). Despite a higher equipment cost in the CBA than the CF-RFA group, the total procedure cost was similar between the two groups (P = 0.26), primarily driven by a shorter procedure duration that resulted in a lower anesthesia cost. At 25 ± 5 months after a single ablation procedure, 51 patients (72%) in the CBA, and 55 patients (73%) in the CF-RFA groups remained free from atrial arrhythmias without antiarrhythmic drug therapy (P = 0.84). CONCLUSIONS: The procedure duration was approximately 60 minutes shorter with CBA than CF-RFA. The procedural costs were similar with both approaches. At 2 years after a single procedure, CBA and CF-RFA have similar single-procedure efficacies of 72-73%.

Investigating Regional Variation of Cardiac Implantable Electrical Device Implant Rates in European Healthcare Systems: What Drives Differences?

Despite established efficacy for cardiac implantable electrical devices (CIEDs), large differences in CIED implant rates have been documented across and within countries. The aim of this paper is to investigate the influence of socio-economic, epidemiological and supply side factors on CIED implant rates across 57 Regions in 5 EU countries and to assess the feasibility of using administrative data for this purpose. A total of 1 330 098 hospitalizations for CIED procedures extracted from hospital discharge databases in Austria, England, Germany, Italy and Slovenia from 2008 to 2012 was used in the analysis. Higher levels of tertiary education among the labour force and percent of aged population are positively associated with implant rates of CIED. Regional per capita GDP and number of implanting centres appear to have no significant effect. Institutional factors are shown to be important for the diffusion of CIED. Wide variation in CIED implant rates across and within five EU countries is undeniable. However, regional factors play a limited part in explaining these differences with few exceptions. Administrative databases are a valuable source of data for investigating the diffusion of medical technologies, while the choice of appropriate modelling strategy is crucial in identifying the drivers for variation across countries. © 2017 The Authors. Health Economics published by John Wiley & Sons, Ltd.

The use of imaging for electrophysiological and devices procedures: a report from the first European Heart Rhythm Association Policy Conference, jointly organized with the European Association of Cardiovascular Imaging (EACVI), the Council of Cardiovascular Imaging and the European Society of Cardiac Radiology.

Implantations of cardiac devices therapies and ablation procedures frequently depend on accurate and reliable imaging modalities for pre-procedural assessments, intra-procedural guidance, detection of complications, and the follow-up of patients. An understanding of echocardiography, cardiovascular magnetic resonance imaging, nuclear cardiology, X-ray computed tomography, positron emission tomography, and vascular ultrasound is indispensable for cardiologists, electrophysiologists as well as radiologists, and it is currently recommended that physicians should be trained in several imaging modalities. There are, however, no current guidelines or recommendations by electrophysiologists, cardiac imaging specialists, and radiologists, on the appropriate use of cardiovascular imaging for selected patient indications, which needs to be addressed. A Policy Conference on the use of imaging in electrophysiology and device management, with representatives from different expert areas of radiology and electrophysiology and commercial developers of imaging and device technologies, was therefore jointly organized by European Heart Rhythm Association (EHRA), the Council of Cardiovascular Imaging and the European Society of Cardiac Radiology (ESCR). The objectives were to assess the state of the level of evidence and a first step towards a consensus document for currently employed imaging techniques to guide future clinical use, to elucidate the issue of reimbursement structures and health economy, and finally to define the need for appropriate educational programmes to ensure clinical competence for electrophysiologists, imaging specialists, and radiologists.

US health care policy and reform: implications for cardiac electrophysiology.

In response to unsustainably rising costs, variable quality and access to health care, and the projected insolvency of vital safety net insurance programs, the federal government has proposed important health policy and regulatory changes in the USA. The US Supreme Court's decision to uphold most of the major provisions of the Affordable Care Act will lead to some of the most sweeping government reforms on entitlements since the creation of Medicare. Furthermore, implementation of new organizational, reimbursement, and health care delivery models will strongly affect the practice of cardiac electrophysiology. In this brief review, we will provide background and context to the problem of rising health care costs and describe salient reforms and their projected impacts on the field and practice of cardiac electrophysiology.

Application of bioreactance for cardiac output assessment during exercise in healthy individuals.

In patients with cardiac failure, bioreactance-based cardiac output (CO) monitoring provides a valid non-invasive method for assessing cardiac performance during exercise. The purpose of this study was to evaluate the efficacy of this technique during strenuous exercise in healthy, trained individuals. Fourteen recreational cyclists, mean (SD) age of 34 (8) years and relative peak oxygen uptake of (VO(2)) 56 (6) ml kg(-1) min(-1), underwent incremental maximal exercise testing, whilst CO was recorded continuously using a novel bioreactance-based device (CO(bio)). The CO(bio) was evaluated against relationship with VO(2), theoretical calculation of arterial-venous oxygen difference (C(a - v) O(2)) and level of agreement with an inert gas rebreathing method (CO(rb)) using a Bland-Altman plot. Bioreactance-based CO measurement was practical and straightforward in application, although there was intermittent loss of electrocardiograph signal at high-intensity exercise. At rest and during exercise, CO(bio) was strongly correlated with VO(2) (r = 0.84; P < 0.001), however, there was evidence of systematic bias with CO(bio) providing lower values than CO(rb); mean bias (limits of agreement) -19% (14.6 to -53%). Likewise, calculated (C(a - v) O(2)) was greater when determined using CO(bio) than CO(rb) (P < 0.001), although both devices provided values in excess of those reported in invasive studies. Bioreactance-based determination of CO provides a pragmatic approach to the continuous assessment of cardiac performance during strenuous exercise in trained individuals. Our findings, however, suggest that further work is needed to refine the key measurement determinants of CO using this device to improve measurement accuracy in this setting.

The quick-implantable-defibrillator trial.

AIMS: Earlier ICD therapy included an electrophysiological study (EPS), an extensive defibrillation threshold test (DFT), and a pre-discharge test. Now that ICD-therapy is widely accepted, an EPS is no longer performed in most patients, extensive DFT-tests have been reduced to a minimum of two effective shocks and discharge tests have been discarded in most centres. However, it has never been demonstrated prospectively that this simplification is safe. METHODS AND RESULTS: The Quick-Implantable-Defibrillator (Quick-ICD) Trial was a prospective multi-centre trial, which randomized patients, who had survived a cardiac arrest (SCD) or an unstable ventricular tachycardia (VT), to two different clinical strategies: (a) The extensive strategy included an EPS, an extensive DFT-test, and a pre-discharge test; (b) In the simplified approach (quick strategy) the ICD was implanted without an EPS and a pre-discharge test. Two effective shocks during implantation at 21 J were sufficient. The primary endpoint of this trial was a cluster of adverse events related to the diagnostic approach and to ICD-therapy. One hundred and ninety patients were included, 97 randomized to the extensive-, 93 to the quick strategy. Mean follow-up was 12 +/- 7 months. Twenty-seven patients reached the endpoint in the quick group and 32 in the extensive group. During follow-up, the event-free survival was equal in the two study arms (test for equivalence, P = 0.0044). The initial hospital stay was significantly shorter in the quick population (8.4 +/- 4.7 vs. 11.2 +/- 7.4 days, P = 0.004) CONCLUSION: It is safe and cost-effective to implant an ICD without an EPS, an extensive DFT-, and a pre-discharge test in carefully selected patients after survived SCD or unstable VTs.

Utility of T-wave alternans in congestive heart failure.

The use of implantable cardioverter defibrillator (ICD) in heart failure patients decreases the arrhythmic mortality with the cost of increasing the number of patients to be treated, and microvolt T-wave alternans (MTWA) testing can be used as a good criteria to better select the candidate for such a therapy. This article examines generalities about the mechanism of alternans, definitions of positive, negative, and indeterminate MTWA tests, and factors that can modify these results. We review clinical studies that have found MTWA as a marker of ventricular arrhythmias in patients with heart failure, independent of etiology, ischemic or idiopathic. Microvolt T-wave alternans permits the selection of low risk patients who may not benefit of ICD implantation by standard criteria, due to high negative predictive values in most studies.

Cost-effectiveness of a microvolt T-wave alternans screening strategy for implantable cardioverter-defibrillator placement in the MADIT-II-eligible population.

OBJECTIVES: This study was designed to compare the cost-effectiveness of implantable cardioverter-defibrillator (ICD) placement with and without risk stratification with microvolt T-wave alternans (MTWA) testing in the MADIT-II (Second Multicenter Automatic Defibrillator Implantation Trial) eligible population. BACKGROUND: Implantable cardioverter-defibrillators have been shown to prevent mortality in the MADIT-II population. Microvolt T-wave alternans testing has been shown to be effective in risk stratifying MADIT-II-eligible patients. METHODS: On the basis of published data, cost-effectiveness of three therapeutic strategies in MADIT-II-eligible patients was assessed using a Markov model: 1) ICD placement in all; 2) ICD placement in patients testing MTWA non-negative;, and 3) medical management. Outcomes of expected cost, quality-adjusted life-years (QALYs), and incremental cost-effectiveness were determined for patient lifetime. RESULTS: Under base-case assumptions, providing ICDs only to those who test MTWA non-negative produced a gain of 1.14 QALYs at an incremental cost of 55,700 dollars when compared to medical therapy, resulting in an incremental cost-effectiveness ratio (ICER) of 48,700 dollars/QALY. When compared with a MTWA risk-stratification strategy, placing ICDs in all patients resulted in an ICER of 88,700 dollars/QALY. Most (83%) of the potential benefit was achieved by implanting ICDs in the 67% of patients who tested MTWA non-negative. Results were most sensitive to the effectiveness of MTWA as a risk-stratification tool, MTWA negative screen rate, cost and efficacy of ICD therapy, and patient risk for arrhythmic death. CONCLUSIONS: Risk stratification with MTWA testing in MADIT-II-eligible patients improves the cost-effectiveness of ICDs. Implanting defibrillators in all MADIT-II-eligible patients, however, is not cost-effective, with one-third of patients deriving little additional benefit at great expense.

[Respective interest of two techniques of electrophysiological study in patient without heart disease]. / Intérêt respectif de deux techniques d'etude electrophysiologique chez un sujet 'a coeur apparemment sain.

UNLABELLED: Electrophysiologic study (EPS) frequently is required to assess the prognosis of asymptomatic Wolff-Parkinson-White syndrome (WPW) or to prove the nature of no documented tachycardia. EPS usually is performed by intracardiac route and hospitalization is required. Similar data are given by an EPS performed by oesophageal route during a consultation. The purpose of the study was to evaluate the cost of both techniques in France. Transesophageal EPS was performed during a consultation in 100 patients with asymptomatic WPW syndrome and 100 patients with no heart disease, complaining of no documented tachycardias with abrupt beginning and end, suggesting a paroxysmal junctional re-entrant tachycardia (PJRT). The cost of transesophageal study including isoproterenol infusion is 127.75 euros. The cost of intracardiac EPS is at least 1460 euros, cost of hospitalization during only one day. RESULTS: In patients with WPW syndrome, 15 had a potentially malignant form with the induction of a tachycardia conducted through the accessory pathway at a high rate (> 240/min in control state, > 300/min with isoproterenol); radiofrequency catheter ablation was indicated in a second time. In the group with no documented tachycardia, PJRT was induced in 30 patients and indication of ablation was discussed. In other 155 patients with either a benign form of WPW syndrome or with a tachycardia unrelated to a PJRT, hospitalization was not required; in these patients, intracardiac study performed during one day of hospitalization would have costed 226,300 Euros. The cost for the esophageal EPS and a similar diagnosis was 19,801 Euros, with a save money of 206,499 Euros. In 45 patients in whom hospitalization was indicated in a second time to perform catheter ablation of the arrhythmia, the cost related to esophageal EPS was 5749 Euros. In the total group, considering the final diagnosis and the need of hospitalization in 45 patients, the save money related to the use of esophageal EPS was 206,499 E-5749 E = 200,750 euros. CONCLUSIONS: We should take into account the cost studies, when various techniques could be used for a similar diagnosis. There are important differences in the cost of diagnostic methods and it is easy to decrease this cost.

Experiencia de plan piloto para pacientes del FONASA portadores de arritmias atendidos en el Hospital Clínico de la Pontificia Universidad Católica de Chile / Treatment of beneficiaries of the Chilean public health system with arrhythmias in a University Clinical Hospital

Background: The costs of medical care increase along with technological advances. Therefore, highly complex and expensive procedures should be performed in a limited number of institutions. Aim: To report the initial experience on electrophysiological studies performed to beneficiaries of a public health insurance system in Chile (FONASA). Material and methods: An agreement was reached between the Electrophysiology Unit of the Clinical Hospital of the Catholic University and FONASA, to perform electrophysiological studies at a minimal cost, that only considered disposable materials and hospital stay. Thirty patients with supraventricular arrhythmias or ventricular arrhythmias without an associated cardiopathy, were attended using this agreement at the unit. Results: In all treated patients, arrhythmias disappeared. Costs remained within the assigned budget, excepting occasional complementary tests. Conclusions: This pioneering experience demonstrated that it is possible that public health insurance systems can buy complex and expensive procedures to private hospitals.