Forward-Solution Noninvasive Computational Arrhythmia Mapping: The VMAP Study.

BACKGROUND: The accuracy of noninvasive arrhythmia source localization using a forward-solution computational mapping system has not yet been evaluated in blinded, multicenter analysis. This study tested the hypothesis that a computational mapping system incorporating a comprehensive arrhythmia simulation library would provide accurate localization of the site-of-origin for atrial and ventricular arrhythmias and pacing using 12-lead ECG data when compared with the gold standard of invasive electrophysiology study and ablation. METHODS: The VMAP study (Vectorcardiographic Mapping of Arrhythmogenic Probability) was a blinded, multicenter evaluation with final data analysis performed by an independent core laboratory. Eligible episodes included atrial and ventricular: tachycardia, fibrillation, pacing, premature atrial and ventricular complexes, and orthodromic atrioventricular reentrant tachycardia. Mapping system results were compared with the gold standard site of successful ablation or pacing during electrophysiology study and ablation. Mapping time was assessed from time-stamped logs. Prespecified performance goals were used for statistical comparisons. RESULTS: A total of 255 episodes from 225 patients were enrolled from 4 centers. Regional accuracy for ventricular tachycardia and premature ventricular complexes in patients without significant structural heart disease (n=75, primary end point) was 98.7% (95% CI, 96.0%-100%; P<0.001 to reject predefined H0 <0.80). Regional accuracy for all episodes (secondary end point 1) was 96.9% (95% CI, 94.7%-99.0%; P<0.001 to reject predefined H0 <0.75). Accuracy for the exact or neighboring segment for all episodes (secondary end point 2) was 97.3% (95% CI, 95.2%-99.3%; P<0.001 to reject predefined H0 <0.70). Median spatial accuracy was 15 mm (n=255, interquartile range, 7-25 mm). The mapping process was completed in a median of 0.8 minutes (interquartile range, 0.4-1.4 minutes). CONCLUSIONS: Computational ECG mapping using a forward-solution approach exceeded prespecified accuracy goals for arrhythmia and pacing localization. Spatial accuracy analysis demonstrated clinically actionable results. This rapid, noninvasive mapping technology may facilitate catheter-based and noninvasive targeted arrhythmia therapies. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04559061.

Ninety-day postoperative cost in primary total hip arthroplasty: an economic model comparing surgical approaches.

BACKGROUND: While primary total hip arthroplasty (THA) is a safe and effective procedure, it is unclear whether choice of surgical approach influences health care cost. METHODS: We developed an economic model in which patients receiving THA via the anterior approach (AA) by high volume anterior hip surgeons were compared to a propensity-score matched cohort of primary THA cases performed by high volume surgeons that were identified from Medicare claims (Control). Cost elements included the procedure and hospital stay, postacute care, readmission, and outpatient care through 90 days postoperatively. Costs were derived from Medicare claims and adjusted to account for nationwide payer mix. RESULTS: Health care costs over 90 days postoperative were $17,763 with AA and $23,969 with Control, a difference of $6,206 (95% CI: $5,210-$7,204) per patient. The cost savings with AA were mainly attributable to lower per-patient costs of the index hospitalization ($13,578 vs $16,017), postacute care ($3,123 vs $6,037), and hospital readmissions ($700 vs $1,584). CONCLUSION: The AA for primary THA was found to lower 90-day health care costs when compared to a matched sample of THA cases. These study findings may be used to inform hospitals and health care payers regarding the cost implications associated with selection of different surgical approaches to primary THA.

Cost-effectiveness analysis of six therapies for the treatment of lower urinary tract symptoms due to benign prostatic hyperplasia.

OBJECTIVE: To conduct a cost-effectiveness analysis from payers' perspectives of six treatments for lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) and to examine positioning of these modalities in the marketplace for the best use of health care funds and quality-of-life benefits for patients. METHODS: The economic analysis was conducted with a Markov model to compare combination prescription drug therapy (ComboRx), minimally invasive therapies (MITs) including convective radiofrequency (RF) water vapor thermal therapy (Rezum®), conductive RF thermal therapy (Prostiva®), and prostatic urethral lift (UroLift®), and invasive surgical procedures including photovaporization of the prostate (Greenlight® PVP) and transurethral resection of the prostate (TURP). Effects assessed with International Prostate Symptom Score, adverse events, and re-treatment rates were estimated from medical literature; treatments effects were modeled using a common baseline score. Starting with each therapy, patients' transitions to more intensive therapies when symptoms returned were simulated in 6-month cycles over 2 years. Incremental cost-effectiveness ratios (ICERs) were calculated for pairs of treatments; uncertainty in ICERs was estimated with probabilistic sensitivity analyses. RESULTS: ComboRx was least effective and provided one-third of the symptom relief achieved with MITs. UroLift was similar in effectiveness to Prostiva and Rezum but costs more than twice as much. The cheaper MITs were ~$900 more expensive than the cost of ComboRx generic drugs over 2 years. TURP and PVP provided slightly greater relief of LUTS than MITs at approximately twice the cost over 2 years; typically, they are reserved for treatment of more severe LUTS. CONCLUSION: The analysis evaluated the costs and symptom relief of six treatment options in the continuum of care from a common baseline of LUTS severity. Identification of treatments for LUTS/BPH that demonstrate cost-effectiveness and provide appreciable symptom relief is paramount as reimbursement for patient care moves from volume-based services to value-based services.

Office-Based HE-TUMT Costs Less than Medication over Four Years in Treating Benign Prostatic Hyperplasia.

OBJECTIVES: Benign prostatic hyperplasia (BPH) can cause lower urinary tract symptoms (LUTS). Medications are first line treatment for mild-moderate BPH. Office-based minimally invasive therapies (MITs) are also acceptable early treatment options but comparisons of MIT to medications are limited. MIT may be equally effective and less costly compared to long-term medical therapy. We compared data from a medication trial to pooled data of high-energy transurethral microwave therapy (HE-TUMT) to evaluate differences in outcomes and costs between the modalities. STUDY DESIGN: Covariate-adjusted comparison of treatments from independent clinical trials. MATERIALS AND METHODS: Data from Medical Therapy of Prostatic Symptoms (MTOPS) study arms were compared to Urologix pooled data from seven HE-TUMT studies at 25 centers. Improvements in voiding symptoms and quality of life (QoL) were determined and a repeated measure logistic regression analysis to control for baseline covariates was performed. Cost data were collected using published outcomes, Medicare 2013 national averages, and discount online pharmacy prices. RESULTS: HE-TUMT provided significant improvement in voiding symptoms and QoL compared to all MTOPS arms through two years. At four years, all therapies maintain similar improvements when adjusting for baseline covariates. Four year cumulative costs of HE-TUMT ($3,620) were less than combination medical therapy ($7,200). CONCLUSIONS: HE-TUMT provides better improvement of LUTS compared to medication for two years. At four years, all therapies provide comparable improvement but HE-TUMT is less expensive with better QoL. This suggests that HE-TUMT is an excellent alternative to medical therapy that should be routinely discussed and offered during detailed management of BPH.

Cost-effectiveness of the convergent procedure and catheter ablation for non-paroxysmal atrial fibrillation.

OBJECTIVE: Patients with persistent or longstanding atrial fibrillation have modest success achieving sinus rhythm with catheter ablation or rhythm control medications. Their high risk of stroke, bleed, and heart failure leads to significant morbidity and health care costs. The convergent procedure has been shown to be successful in this population, with 80% of patients in sinus rhythm after 1 year. This study evaluated the cost-effectiveness of the convergent procedure, catheter ablation, and medical management for non-paroxysmal AF patients. METHODS: A Markov micro-simulation model was used to estimate costs and effectiveness from a payer perspective. Parameter estimates were from the literature. Three patient cohorts were simulated, representing lower, medium, and higher risks of stroke, bleed, heart failure, and hospitalization. Effects were estimated by quality-adjusted life-years (QALYs). Single-variable sensitivity analysis was performed. RESULTS: After 5 years, convergent procedure patients averaged 1.10 procedures, with 75% of survivors in sinus rhythm; catheter ablation patients had 1.65 procedures, with 49% in sinus rhythm. Compared to medical management, catheter ablation and the convergent procedure were cost-effective for the lower risk (ICER <$35,000) and medium risk (ICER <$15,000) cohorts. The procedures dominated medical management for the higher risk cohort (lower cost and higher QALYs). The convergent procedure dominated catheter ablation for all risk cohorts. RESULTS were subject to simplifying assumptions and limited by uncertain factors such as long-term maintenance of sinus rhythm after successful procedure and incremental AF-associated event rates for AF patients relative to patients in sinus rhythm. In the absence of clinical trial data, convergent procedure efficacy was estimated with observational evidence. Limitations were addressed with sensitivity analyses and a moderate 5 year time horizon. CONCLUSION: The convergent procedure results in superior maintenance of post-ablation sinus rhythm with fewer repeat ablation procedures compared to catheter ablation, leading to lower cost and higher QALYs after 5 years.

Cost effectiveness of radiofrequency microremodeling for stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: Stress urinary incontinence (SUI) is a common and growing problem among adult women and affects individuals and society through decreased quality of life (QoL), decreased work productivity, and increased health care costs. A new, nonsurgical treatment option has become available for women who have failed conservative therapy, but its cost effectiveness has not been evaluated. This study examined the cost effectiveness of transurethral radiofrequency microremodeling of the female bladder neck and proximal urethra compared with synthetic transobturator tape (TOT), retropubic transvaginal tape (TVT) sling, and Burch colposuspension surgeries for treating SUI. METHODS: A Markov model was used to compare the cost effectiveness of five strategies for treating SUI for patients who had previously failed conservative therapy. The strategies were designed to compare the value of starting with a less invasive treatment. The cost-effectiveness analysis was conducted from the health care system perspective. Efficacy and adverse event rates were obtained from the literature; reimbursement costs were based on Medicare fee schedule. The model cycle was 3 months, with a 3-year time horizon. Single-variable sensitivity analyses were conducted to assess stability of base-case results. RESULTS: Two of the five strategies employed the use of transurethral radiofrequency microremodeling and achieved 17-30 % lower mean costs relative to their comparative sling or Burch strategies. CONCLUSIONS: Superior safety and cost effectiveness are recognized when patients are offered a sequential approach to SUI management that employs transurethral radiofrequency microremodeling before invasive surgical procedures. This sequential approach is consistent with treatment strategies for other conditions and offers a solution for women with SUI who want to avoid the inherent risks and costs of invasive continence surgery.

Cost-effectiveness of gemfibrozil for coronary heart disease patients with low levels of high-density lipoprotein cholesterol: the Department of Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial.

BACKGROUND: Although numerous clinical trials and economic analyses have established the efficacy and cost-effectiveness of lowering cholesterol for the prevention of coronary heart disease, there are few data on the role of raising high-density lipoprotein cholesterol (HDL-C) levels and lowering triglyceride levels. The US Department of Veterans Affairs (VA) Cooperative Studies Program HDL-C Intervention Trial (VA-HIT) was a multicenter, randomized trial of gemfibrozil, an agent that raised HDL-C levels and lowered triglyceride levels, yet had no effect on low-density lipoprotein cholesterol (LDL-C) levels. The study showed that gemfibrozil therapy significantly reduced major cardiovascular events (cardiovascular death, myocardial infarction, and stroke) in patients with coronary heart disease, low HDL-C levels, and low LDL-C levels. OBJECTIVE: To report the results of a cost-effectiveness study based on the results of the VA-HIT. METHODS: The cost per year of life gained with gemfibrozil therapy was calculated. Hazard functions were estimated, and the resulting probabilities were used in a Markov model simulation to estimate the effect of gemfibrozil on life expectancy and costs over a simulated lifetime. Sensitivity analyses were used to account for uncertainty. RESULTS: Using the prices of gemfibrozil that were negotiated by the VA, gemfibrozil was cost saving. Using drug prices found outside the VA, a quality-adjusted life-year saved by gemfibrozil therapy cost between $6300 and $17 100. CONCLUSIONS: Gemfibrozil reduces major cardiovascular events in male coronary heart disease patients with low levels of HDL-C and low levels of LDL-C and would result in cost saving at annual drug costs of $100 or less in 1998 dollars. Even at the higher drug prices represented by the average wholesale price in the United States, the cost of a life-year saved is well below the threshold that would be deemed cost-effective. To our knowledge, this is the first economic analysis based on clinical trial data to assess the cost-effectiveness of raising HDL-C levels and lowering triglyceride levels in a setting in which LDL-C levels were not lowered.