Disparities in the Management of Newly Diagnosed Paroxysmal Supraventricular Tachycardia for Women Versus Men in the United States.

Background Information on differences in paroxysmal supraventricular tachycardia (PSVT) diagnosis, healthcare resource use, expenditures, and treatment among women versus men is limited. Methods and Results Study participants identified in the IBM MarketScan Commercial Research Databases were aged 18 to 40 years with newly diagnosed PSVT (International Classification of Diseases, Ninth Revision [ICD-9]: 427.0; International Classification of Diseases, Tenth Revision [ICD-10]: I47.1) from October 1, 2012, through September 30, 2016, observable 1 year preindex and postindex diagnosis. Study outcomes were mean annual per-patient healthcare resource use and expenditures before and after diagnosis. Among 5466 patients newly diagnosed with PSVT, most (66.9%) were women. Compared with men, women with PSVT tended to have higher rates of anxiety (13.9% versus 10.9%; P<0.01) and chronic pulmonary disease (10.9% versus 8.3%; P<0.01). Following diagnosis, mean annual per-patient expenditures increased for all patients, but were significantly lower for women ($26 922 versus $33 112; P<0.05), reflecting lower spending for services billed as a result of a PSVT diagnosis ($8471 versus $11 405; P<0.05). After diagnosis, nearly half of all patients had at least 1 emergency department visit (women versus men, 49.6% versus 44.5%; P<0.01) and more had hospital admissions (women versus men, 24.7% versus 20.0%; P<0.01). Fewer women were treated with cardiac ablation (12.6% versus 15.3%; P<0.01), and more were treated with medical therapy, including ß blockers or calcium channel blockers (odds ratio, 1.15; 95% CI, 1.02-1.31). Conclusions Among patients aged 18 to 40 years, ≈2 of 3 patients diagnosed with PSVT were women. After diagnosis, spending was significantly lower for women, reflecting lower ablation rates and less spending on services with a PSVT diagnosis.

Cost-effectiveness of ablation of ventricular tachycardia in ischaemic cardiomyopathy: limitations in the trial evidence base.

Objective: Catheter ablation is an important treatment for ventricular tachycardia (VT) that reduces the frequency of episodes of VT. We sought to evaluate the cost-effectiveness of catheter ablation versus antiarrhythmic drug (AAD) therapy. Methods: A decision-analytic Markov model was used to calculate the costs and health outcomes of catheter ablation or AAD treatment of VT for a hypothetical cohort of patients with ischaemic cardiomyopathy and an implantable cardioverter-defibrillator. The health states and input parameters of the model were informed by patient-reported health-related quality of life (HRQL) data using randomised clinical trial (RCT)-level evidence wherever possible. Costs were calculated from a 2018 UK perspective. Results: Catheter ablation versus AAD therapy had an incremental cost-effectiveness ratio (ICER) of £144 150 (€161 448) per quality-adjusted life-year gained, over a 5-year time horizon. This ICER was driven by small differences in patient-reported HRQL between AAD therapy and catheter ablation. However, only three of six RCTs had measured patient-reported HRQL, and when this was done, it was assessed infrequently. Using probabilistic sensitivity analyses, the likelihood of catheter ablation being cost-effective was only 11%, assuming a willingness-to-pay threshold of £30 000 used by the UK's National Institute for Health and Care Excellence. Conclusion: Catheter ablation of VT is unlikely to be cost-effective compared with AAD therapy based on the current randomised trial evidence. However, better designed studies incorporating detailed and more frequent quality of life assessments are needed to provide more robust and informed cost-effectiveness analyses.

Health Care Utilization After Ventricular Tachycardia Ablation: A Propensity Score-Matched Cohort Study.

BACKGROUND: Catheter ablation of ventricular tachycardia (VT) can reduce the burden of ventricular arrhythmia (VA) but its effect on health care utilization and costs after such therapy is poorly known. We sought to compare the rates of cardiovascular (CV)-related hospitalizations, survival, and health care costs in patients with recurrent VT treated either with VT ablation or with medical therapy. METHODS: One-hundred implantable cardioverter-defibrillator patients with structural heart disease who underwent VT ablation were included. Propensity score-matched patients with recurrent VT treated with medical therapy were identified from a prospective registry of approximately 7000 de novo implantable cardioverter-defibrillator patients. Outcomes and costs were ascertained using health administrative databases. RESULTS: Among patients who underwent VT ablation, the cumulative rates of VA-related hospitalizations were lower in the 2 years after their ablation procedure compared with the year before (rate ratio, 0.3; 95% confidence interval [CI], 0.22-0.43). Rates of CV-related hospitalization and hospitalization because of VA post index date were similar between the VT ablation and medical therapy groups (hazard ratio [HR], 0.94; 95% CI, 0.57-1.54 and HR, 1.04; 95% CI, 0.57-1.91, respectively). Health care costs in the VT ablation patients were not increased post-ablation compared with the medical management group. The risk of all-cause mortality was lower among patients in the VT ablation group relative to the medical therapy group (HR, 0.64; 95% CI, 0.4-0.99). CONCLUSIONS: Patients who underwent VT ablation experienced a significant reduction in their rate of VA-related hospitalizations. Patients treated with VT ablation had similar rates of CV-related hospitalization compared with those treated with medical therapy without increased health care-related costs.

Impact of ventricular tachycardia ablation on health care utilization.

BACKGROUND: Catheter ablation of ventricular tachycardia (VT) has been shown to reduce the number of recurrent shocks in patients with an implantable cardioverter-defibrillator (ICD). However, how VT ablation affects postprocedural medical and pharmaceutical usage remains unclear. OBJECTIVE: The purpose of this study was to investigate changes in health care resource utilization (HCRU) after VT ablation. METHODS: This large-scale, real-world, retrospective study used the MarketScan databases to identify patients in the United States with an ICD or cardiac resynchronization therapy-defibrillator (CRT-D) undergoing VT ablation. We calculated cumulative medical and pharmaceutical expenditures, office visits, hospitalizations, and emergency room (ER) visits in the 1-year periods before and after ablation. RESULTS: A total of 523 patients met the study inclusion criteria. After VT ablation, median annual cardiac rhythm-related medical expenditures decreased by $5,408. Moreover, the percentage of patients with at least 1 cardiac rhythm-related hospitalization and ER visit decreased from 53% and 41% before ablation to 28% and 26% after ablation, respectively. Similar changes were observed in the number of all-cause hospitalizations and ER visits, but there were no significant changes in all-cause medical expenditures. During the year before VT ablation, there was an increasing rate of health care resource utilization, followed by drastic slowing after ablation. CONCLUSION: This retrospective study demonstrated that catheter ablation seems to reduce hospitalization and overall health care utilization in VT patients with an ICD or CRT-D in place.

Safety of Outpatient Implantation of the Implantable Cardioverter-defibrillator.

INTRODUCTION AND OBJECTIVES: Strategies are needed to reduce health care costs and improve patient care. The objective of our study was to analyze the safety of outpatient implantation of cardioverter-defibrillators. METHODS: A retrospective study was conducted in 401 consecutive patients who received an implantable cardioverter-defibrillator between 2007 and 2012. The rate of intervention-related complications was compared between 232 patients (58%) whose implantation was performed in the outpatient setting and 169 patients (42%) whose intervention was performed in the inpatient setting. RESULTS: The mean age (standard deviation) of the patients was 62 (14) years; 336 (84%) were male. Outpatients had lower left ventricular ejection fraction and a higher percentage had an indication for primary prevention of sudden death, compared to inpatients. Only 21 outpatients (9%) required subsequent hospitalization. The rate of complications until the third month postimplantation was similar for outpatients (6.0%) and inpatients (5.3%); P = .763. In multivariate analysis, only previous anticoagulant therapy was related to the presence of complications (odds ratio = 3.2; 95% confidence interval, 1.4-7.4; P < .01), mainly due to an increased rate of pocket hematomas. Each outpatient implantation saved approximately €735. CONCLUSIONS: Outpatient implantation of implantable cardioverter-defibrillators is safe and reduces costs. Close observation is recommended for patients receiving chronic anticoagulation therapy due to an increased risk of complications.

Frequencies, costs, and complications of catheter ablation for tachyarrhythmias in children: 2000-2009.

BACKGROUND: Over the past two decades, catheter ablation (CA) has revolutionized the treatment of tachyarrhythmias in children by providing a relatively safe and effective alternative to open heart surgery or lifelong pharmacotherapy. This study (1) described national trends in pediatric CAs and their associated costs and complications and (2) predicted the likelihood of major complications based on patient and hospital characteristics. METHODS: Inpatient data were obtained from the Kids' Inpatient Database for the years 2000, 2003, 2006, and 2009. Outpatient data were obtained from the California, Maryland, and New Jersey State Ambulatory Surgery Databases for the years 2006 and 2009. Logistic regression was used to predict the odds of major complications from CA. RESULTS: There was a 20% increase (4,134-4,967) in the number of pediatric CAs performed from 2006 to 2009 that was concomitant with a decrease in the percentage of those procedures being performed as inpatient procedures (2,254-1,846). In 2009, a complication rate of 4.81% was estimated. For inpatient CAs, higher risk patients (with congenital heart disease, congestive heart failure, or heart transplant), ablations for ventricular tachycardias, and low-CA-volume hospitals were associated with increased risk of complications. In 2009, the mean cost of a hospitalization involving CA, but no cardiac surgery, was $17,204 (standard error = $1,015). CONCLUSIONS: CA has increasingly been used over the past decade for pediatric patients with a multitude of tachycardia mechanisms. There continues to be a small risk of major complications, especially for higher risk children and in hospitals with more limited experience with the procedure.

Lack of current implantable cardioverter defibrillator guidelines application for primary prevention of sudden cardiac death in Latin American patients with heart failure: a cross-sectional study.

AIMS: This cross-sectional study evaluated the application of accepted international implantable cardioverter defibrillator (ICD) guidelines for primary prevention of sudden cardiac death in patients with heart failure. METHODS AND RESULTS: The PLASMA (Probabilidad de Sufrir Muerte Arritmica) study was designed to characterize management of cardiac patients in Latin America. Twelve centres included 1958 consecutively admitted patients in cardiology units in 2008 and 2009. Discharged patients were evaluated for primary prevention, ICD indication and prescription by general cardiologists. Of 1711 discharged patients, 1525 (89%) had data available for evaluating indication status. Class I indications for ICD therapy were met for 153 (10%) patients based on collected data. Only 20 (13%, 95% confidence interval: 7.7-18.4%) patients with indication were prescribed an ICD. Patients prescribed an ICD were younger than patients who were not prescribed an ICD (62 vs. 68 years, P < 0.01). The reasons given by cardiologists for not prescribing an ICD for 133 patients with an indication were: indication criteria not met (75%), life expectancy <1 year (9.7%), rejection by the patient (5.2%), no medical coverage paying for the device (3.7%), psychiatric patient (2.2%), and other reasons (4.2%). CONCLUSIONS: In Latin America, international guidelines for primary prevention ICD implantation are not well followed. The main reason is that cardiologists believe that patients do not meet indication criteria, even though study data confirm that criteria are met. This poses a significant challenge and underlines the importance of continuous and improved medical education.

The effectiveness and cost effectiveness of public-access defibrillation.

Many sudden cardiac deaths are due to ventricular fibrillation (VF). The use of defibrillators in hospitals or by outpatient emergency medical services (EMS) personnel can save many cardiac-arrest victims. Automated external defibrillators (AEDs) permit defibrillation by trained first responders and laypersons. AEDs are available at most public venues, and vast sums of money are spent installing and maintaining these devices. AEDs have been evaluated in a variety of public and private settings. AEDs accurately identify malignant ventricular tachyarrhythmias and frequently result in successful defibrillation. Prompt application of an AED shows a greater number of patients in VF compared with initial rhythms documented by later-arriving EMS personnel. Survival is greatest when the AED is placed within 3 to 5 minutes of a witnessed collapse. Community-based studies show increased cardiac-arrest survival when first responders are equipped with AEDs rather than waiting for paramedics to defibrillate. Wide dissemination of AEDs throughout a community increases survival from cardiac arrest when the AED is used; however, the AEDs are utilized in a very small percentage of all out-of-hospital cardiac arrests. AEDs save very few lives in residential units such as private homes or apartment complexes. AEDs are cost effective at sites where there is a high density of both potential victims and resuscitators. Placement at golf courses, health clubs, and similar venues is not cost effective; however, the visible devices are good for public awareness of the problem of sudden cardiac death and provide reassurance to patrons.

Amiodarone versus implantable cardioverter-defibrillator:randomized trial in patients with nonischemic dilated cardiomyopathy and asymptomatic nonsustained ventricular tachycardia--AMIOVIRT.

OBJECTIVES: The purpose of this multicenter randomized trial was to compare total mortality during therapy with amiodarone or an implantable cardioverter-defibrillator (ICD) in patients with nonischemic dilated cardiomyopathy (NIDCM) and nonsustained ventricular tachycardia (NSVT). BACKGROUND: Whether an ICD reduces mortality more than amiodarone in patients with NIDCM and NSVT is unknown. METHODS: One hundred three patients with NIDCM, left ventricular ejection fraction < or =0.35, and asymptomatic NSVT were randomized to receive either amiodarone or an ICD. The primary end point was total mortality. Secondary end points included arrhythmia-free survival, quality of life, and costs. RESULTS: The study was stopped when the prospective stopping rule for futility was reached. The percent of patients surviving at one year (90% vs. 96%) and three years (88% vs. 87%) in the amiodarone and ICD groups, respectively, were not statistically different (p = 0.8). Quality of life was also similar with each therapy (p = NS). There was a trend with amiodarone, as compared to the ICD, towards improved arrhythmia-free survival (p = 0.1) and lower costs during the first year of therapy ($8,879 US dollars vs. $22,039 US dollars, p = 0.1). CONCLUSIONS: Mortality and quality of life in patients with NIDCM and NSVT treated with amiodarone or an ICD are not statistically different. There is a trend towards a more beneficial cost profile and improved arrhythmia-free survival with amiodarone therapy.

Life after a ventricular arrhythmia.

BACKGROUND: There are few data from community-based evaluations of outcomes after a life-threatening ventricular arrhythmia (LTVA). We evaluated patients' quality of life (QOL) and medical costs after hospitalization and treatment for their first episode of an LTVA. METHODS: We prospectively evaluated QOL by use of the Duke Activity Status Index (DASI), Medical Outcomes Study SF-36 mental health and vitality scales, the Cardiac Arrhythmia Suppression Trial (CAST) symptom scale, and resource use in patients discharged after a first episode of an LTVA in a managed care population of 2.4 million members. RESULTS: We enrolled 264 subjects with new cases of LTVA. Although functional status initially decreased compared with self-reports of pre-event functional status, both functional status and symptom levels improved significantly during the study period. These improvements were greater in patients receiving an implantable cardioverter defibrillator (ICD) than in patients receiving amiodarone. Ratings of mental health and vitality were not significantly different between the treatment groups and did not change significantly during follow-up. The total 2-year medical costs were higher for patients receiving an ICD than for patients receiving amiodarone, despite lower costs during the follow-up period for the patients receiving an ICD. CONCLUSIONS: New onset of an LTVA has a substantial negative initial impact on QOL. With therapy, most patients have improvements in their QOL and symptom level, possibly more so after treatment with an ICD. The costs of treating these patients are very high.

Trends in hospital treatment of ventricular arrhythmias among Medicare beneficiaries, 1985 to 1995.

BACKGROUND: Treatment options for patients with ventricular arrhythmias have undergone major changes in the last 2 decades. Trends in use of invasive procedures, clinical outcomes, and expenditures have not been well documented. METHODS: We used administrative databases of Medicare beneficiaries from 1985 to 1995 to identify patients hospitalized with ventricular arrhythmias. We created a longitudinal patient profile by linking the index admission with all earlier and subsequent admissions and with death records. RESULTS: Approximately 85,000 patients aged > or =65 years went to hospitals in the United States with ventricular arrhythmias each year, and about 20,000 lived to admission. From 1987 to 1995, the use of electrophysiology studies and implantable cardioverter defibrillators in patients who were hospitalized grew substantially, from 3% to 22% and from 1% to 13%, respectively. Hospital expenditures rose 8% per year, primarily because of the increased use of invasive procedures. Survival improved, particularly in the medium term, with 1-year survival rates increasing between 1987 and 1994 from 52.9% to 58.3%, or half a percentage point each year. CONCLUSION: Survival of patients who sustain a ventricular arrhythmia is poor, but improving. For patients who are admitted, more intensive treatment has been accompanied by increased hospital expenditures.

Effect of risk stratification on cost-effectiveness of the implantable cardioverter defibrillator.

BACKGROUND: Implantable cardioverter defibrillators (ICDs) effectively prevent sudden cardiac death, but selection of appropriate patients for implantation is complex. We evaluated whether risk stratification based on risk of sudden cardiac death alone was sufficient to predict the effectiveness and cost-effectiveness of the ICD. METHODS: We developed a Markov model to evaluate the cost-effectiveness of ICD implantation compared with empiric amiodarone treatment. The model incorporated mortality rates from sudden and nonsudden cardiac death, noncardiac death and costs for each treatment strategy. We based our model inputs on data from randomized clinical trials, registries, and meta-analyses. We assumed that the ICD reduced total mortality rates by 25%, relative to use of amiodarone. RESULTS: The relationship between cost-effectiveness of the ICD and the total annual cardiac mortality rate is U-shaped; cost-effectiveness becomes unfavorable at both low and high total cardiac mortality rates. If the annual total cardiac mortality rate is 12%, the cost-effectiveness of the ICD varies from $36,000 per quality-adjusted life-year (QALY) gained when the ratio of sudden cardiac death to nonsudden cardiac death is 4 to $116,000 per QALY gained when the ratio is 0.25. CONCLUSIONS: The cost-effectiveness of ICD use relative to amiodarone depends on total cardiac mortality rates as well as the ratio of sudden to nonsudden cardiac death. Studies of candidate diagnostic tests for risk stratification should distinguish patients who die suddenly from those who die nonsuddenly, not just patients who die suddenly from those who live.

Cost-effectiveness of the implantable cardioverter-defibrillator versus antiarrhythmic drugs in survivors of serious ventricular tachyarrhythmias: results of the Antiarrhythmics Versus Implantable Defibrillators (AVID) economic analysis substudy.

BACKGROUND: The implantable cardioverter-defibrillator (ICD) is an effective but expensive device. We used prospectively collected data from a large randomized clinical trial of secondary prevention of life-threatening ventricular arrhythmias to determine the cost-effectiveness of the ICD compared with antiarrhythmic drug (AAD) therapy, largely with amiodarone. METHODS AND RESULTS: Charges for initial and repeat hospitalizations, emergency room, and day surgery stays and the costs of antiarrhythmic drugs were collected on 1008 patients. Detailed records of all other medical encounters and expenses were collected on a subgroup of 237 patients. Regression models were then created to attribute these expenses to the rest of the patients. Charges were converted to 1997 costs using standard methods. Costs and life years were discounted at 3% per year. Three-year survival data from the Antiarrhythmics Versus Implantable Defibrillators trail were used to calculate the base-case cost-effectiveness (C/E) ratio. Six-year, twenty-year, and lifetime C/E ratios were also estimated. At 3 years, total costs were $71 421 for a patient taking AADs and $85 522 for a patient using an ICD, and the ICD provided a 0.21-year survival benefit over AAD treatment. The base-case C/E ratio was thus $66 677 per year of life saved by the ICD compared with AAD therapy (95% CI, $30 761 to $154 768). Six- and 20-year C/E ratios remained stable between $68 000 and $80 000 per year of life saved. CONCLUSIONS: The ICD is moderately cost-effective for secondary prevention of life-threatening ventricular arrhythmias, as judged from prospectively collected data in a randomized clinical trial.

Effect of clinical risk stratification on cost-effectiveness of the implantable cardioverter-defibrillator: the Canadian implantable defibrillator study.

BACKGROUND: Three randomized clinical trials showed that implantable cardioverter-defibrillators (ICDs) reduce the risk of death in survivors of ventricular tachyarrhythmias, but the cost per year of life gained is high. A substudy of the Canadian Implantable Defibrillator Study (CIDS) showed that 3 clinical factors, age >/=70 years, left ventricular ejection fraction /=2 of 3 risk factors. Incremental cost-effectiveness of ICD therapy was computed as the ratio of the difference in mean cost to the difference in life expectancy between the 2 groups. Over 6.3 years, the mean cost per patient in the ICD group was Canadian (C) $87 715 versus $38 600 in the amiodarone group (C$1 approximately US$0.67). Life expectancy for the ICD group was 4.58 years versus 4.35 years for amiodarone, for an incremental cost-effectiveness of ICD therapy of C$213 543 per life-year gained. The cost per life-year gained in patients with >/=2 factors was C$65 195, compared with C$916 659 with <2 risk factors. CONCLUSIONS: The cost-effectiveness of ICD therapy varies by patient risk factor status. The use of ICD therapy in patients who have >/=2 risk factors of age >/=70 years, left ventricular ejection fraction

Safety and potential cost savings of same-setting electrophysiologic testing and placement of transvenous implantable cardioverter-defibrillators.

BACKGROUND: Separately, electrophysiologic study (EPS) and placement of a transvenous implantable cardioverter-defibrillator (ICD) can be performed safely in the majority of patients. The safety and potential cost savings of same-setting procedures have not been evaluated. HYPOTHESIS: Electrophysiologic study and placement of transvenous ICDs can be performed safely in the same setting at reduced cost. METHODS: In all. 160 (mean age 65 +/- 10 years, 75% men) and 41 (mean age 66 +/- 11 years, 73% men) consecutive patients who underwent same- versus separate-setting procedures, respectively, were prospectively evaluated. RESULTS: The two groups had similar clinical characteristics and indications for EPS and ICD therapy. Complications occurred in eight patients (5.0%, 95% confidence interval [CI] 2.3-10.3) who had same-setting procedures (one hypotension during ICD testing, one pocket hematoma, two lead dislodgments, two pneumothoraces, one stroke, and one infection) and in two (4.9%, CI 0.60-16.5) who had separate-setting procedures (one pocket hematoma and one infection). There were no procedure-related deaths or long-term ICD-related complications in either group. The mean time from ICD implantation to hospital discharge was similar in the two groups (2.5 +/- 2.4 vs. 2.7 +/- 2.2 days, p = NS). The combined procedure cost was higher in patients who had separate-setting procedures ($12,403 +/- 1,386 vs. $10,242 +/- 2.256, p = < 0.001). who incurred an additional hospital cost of $2,121 +/- $2,125 for the waiting period (1.7 +/- 1.6 days) between EPS and ICD implantation. CONCLUSIONS: In patients deemed candidates for ICD therapy based on EPS results, placement of transvenous defibrillators in the same setting as EPS is as safe as separate-setting procedures and, if adopted, could further reduce the cost of providing ICD therapy.

Cost-effectiveness of the implantable cardioverter-defibrillator: results from the Canadian Implantable Defibrillator Study (CIDS).

BACKGROUND: In the Canadian Implantable Defibrillator Study (CIDS), we assessed the cost-effectiveness of the implantable cardioverter-defibrillator (ICD) in reducing the risk of death in survivors of previous ventricular tachycardia (VT) or fibrillation (VF). METHODS AND RESULTS: Healthcare resource use was collected prospectively on the first 430 patients enrolled in CIDS (n=212 ICD, n=218 amiodarone). Mean cost per patient, adjusted for censoring, was computed for each group based on initial therapy assignment. Incremental cost-effectiveness of ICD therapy was computed as the ratio of the difference in cost (ICD minus amiodarone) to the difference in life expectancy (both discounted at 3% per year). All costs are in 1999 Canadian dollars (C$1 approximately US$0.65). Over 6.3 years, mean cost per patient in the ICD group was C$87 715 versus C$38 600 in the amiodarone group (difference C$49 115; 95% CI C$25 502 to C$69 508). Life expectancy for the ICD group was 4.58 years versus 4.35 years for amiodarone (difference 0.23, 95% CI -0.09 to 0.55), for incremental cost-effectiveness of ICD therapy of C$213 543 per life-year gained. ICD benefit was greater in patients with low left ventricular ejection fraction (<35%), and cost-effectiveness in this group was more attractive (C$108 484). Alternative extrapolations of survival benefit and costs to 12 years indicated cost-effectiveness in the range of C$100 000 to C$150 000 per life-year gained. CONCLUSIONS: At C$213 543, the value for the money offered by ICD therapy is not attractive by currently accepted standards. Further research is warranted to identify the indications and patient subgroups for whom ICDs are a cost-effective use of resources.