After this time, Nice’s committee will review the technology with the new evidence and make a final recommendation on whether to recommend Zio XT for routine use on the NHS. Patients will have access to this promising new technology for three years while more data is collected to address evidence gaps about its benefit. The medical technology guidance recommends the Zio XT service for detecting abnormal heart rhythms, only if NHS organisations collect further evidence of its benefits. No, Zio ZT is the first assessment, via the Nice digital health technologies guidance development pilot project, to be recommended for NHS use with the caveat that further data must be collected. MTG52: Zio XT for detecting cardiac arrhythmias Does it replace earlier guidance? Zio testing is least cost-effective compared to Model E (combined 48-hour Holter and event monitoring), but this model would miss over one quarter of the Zio findings that led to escalation of care.NICE focus: easy-to-wear device could help detect arrhythmiasĪ new lightweight electrocardiogram that can be worn for two weeks could increase the chances of detecting heart arrhythmias and deliver savings over the medium and long-term. Conclusion: Zio testing is more cost-effective when compared to models of isolated Holter or event monitoring, but less so when compared to models combining these modalities. The cost per management change using Zio testing is $645.58, which is less than Models A or B, but more than Models C-E. Total costs and effects are presented in Table 1. Results: Using Zio testing alone identified findings that led to management change in 55.8% of studies Model E (48 hour Holter + event) represents the next most effective at 45.0%, while Model A (24 hour Holter) represents the least effective at 3.2% (see Figure 1). Costs were assigned using 2018 CMS reimbursement rates, and comparison was made using the incremental cost effectiveness ratio (ICER), which measures the difference in cost divided by the difference in effectiveness. Effectiveness was measured by the percentage of studies that changed clinical management, which included escalation of care (e.g., new medication, intervention, or increased frequency of follow up recommended) or discharge from follow up. The results were analyzed and compared to 5 theoretical models: Model A: 24-hour Holter (using Zio findings from the first 24 hours) Model B: 48-hour Holter Model C: event monitor (only using Zio findings that were patient-triggered) Model D: 24-hour Holter + event (using Zio findings from the first 24 hours plus any subsequent patient-triggered findings) and Model E: 48-hour Holter + event. Methods: This study presents a cost-effectiveness analysis using data collected on 373 Zio studies performed on patients 0-18 years in a pediatric cardiology clinic. We conducted a cost-effectiveness analysis in detecting findings affecting clinical management by comparing Zio monitor testing alone to theoretical models representing the Holter (24- and 48-hour), event monitor, or a combination of these modalities. As compared to traditional Holter or event monitors, this novel technology may have a higher diagnostic yield, but has a higher per-unit cost. Purpose: The Zio (iRhythm Technologies) is a small and adhesive monitor that can be worn for up to 2 weeks to evaluate heart rhythm in an ambulatory setting, with an option for patient triggering to record symptoms.
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