Cost-effectiveness of an insertable cardiac monitor in a high-risk population in the US.

BACKGROUND: Insertable cardiac monitors (ICMs) are a clinically effective means of detecting atrial fibrillation (AF) in high-risk patients, and guiding the initiation of non-vitamin K oral anticoagulants (NOACs). Their cost-effectiveness from a US clinical payer perspective is not yet known. The objective of this study was to evaluate the cost-effectiveness of ICMs compared to standard of care (SoC) for detecting AF in patients at high risk of stroke (CHADS2 ≥ 2), in the US. METHODS: Using patient data from the REVEAL AF trial (n = 393, average CHADS2 score = 2.9), a Markov model estimated the lifetime costs and benefits of detecting AF with an ICM or with SoC (specifically intermittent use of electrocardiograms and 24-h Holter monitors). Ischemic and hemorrhagic strokes, intra- and extra-cranial hemorrhages, and minor bleeds were modelled. Diagnostic and device costs, costs of treating stroke and bleeding events and medical therapy-specifically costs of NOACs were included. Costs and health outcomes, measured as quality-adjusted life years (QALYs), were discounted at 3% per annum, in line with standard practice in the US setting. One-way deterministic and probabilistic sensitivity analyses (PSA) were undertaken. RESULTS: Lifetime per-patient cost for ICM was $31,116 versus $25,330 for SoC. ICMs generated a total of 7.75 QALYs versus 7.59 for SoC, with 34 fewer strokes projected per 1000 patients. The model estimates a number needed to treat of 29 per stroke avoided. The incremental cost-effectiveness ratio was $35,528 per QALY gained. ICMs were cost-effective in 75% of PSA simulations, using a $50,000 per QALY threshold, and a 100% probability of being cost-effective at a WTP threshold of $150,000 per QALY. CONCLUSIONS: The use of ICMs to identify AF in a high-risk population is likely to be cost-effective in the US healthcare setting.

An international survey of deep brain stimulation procedural steps.

BACKGROUND: Deep brain stimulation (DBS) surgery is standard of care for the treatment of certain movement disorders. OBJECTIVE: We sought to characterize the spectrum of steps performed in DBS surgery, at centers around the world where this surgery is performed. METHODS: We identified the main steps in DBS surgery workflow and grouped these 19 steps into 3 phases (preoperative, operative, and postoperative). A survey tool, informed by a pilot survey, was administered internationally by trained study personnel at high- and low-volume DBS centers. Procedural components, duration, and surgeon motivational factors were assessed. Cluster analysis was used to identify procedural and behavioral clusters. RESULTS: One hundred eighty-five procedure workflow surveys (143 DBS centers) and 65 online surveys of surgeon motivational drivers were completed (45% response rate). Significant heterogeneity in technique, operative time, and surgeon motivational drivers was reported across centers. CONCLUSIONS: We provide a description of the procedural steps involved in DBS surgery and the duration of these steps, based on an international survey. These data will enable individual surgeons and centers to examine their own experience relative to colleagues at other centers and in other countries. Such information could also be useful in comparing efficiencies and identifying workflow obstacles between different hospital environments.

Long-term recordings of local field potentials from implanted deep brain stimulation electrodes.

BACKGROUND: Deep brain stimulation (DBS) of the subthalamic nucleus is an effective treatment for Parkinson disease. However, DBS is not responsive to an individual's disease state, and programming parameters, once established, do not change to reflect disease state. Local field potentials (LFPs) recorded from DBS electrodes are being investigated as potential biomarkers for the Parkinson disease state. However, no patient data exist about what happens to LFPs over the lifetime of the implant. OBJECTIVE: We investigated whether LFP amplitude and response to limb movement differed between patients implanted acutely with subthalamic nucleus DBS electrodes and patients implanted 2 to 7 years previously. METHODS: We recorded LFPs at DBS surgery time (9 subjects), 3 weeks after initial placement (9 subjects), and 2 to 7 years (median: 3.5) later during implanted programmable generator replacement (11 sides). LFP power-frequency spectra for each of 3 bipolar electrode derivations of adjacent contacts were calculated over 5-minute resting and 30-second movement epochs. Monopolar impedance data were used to evaluate trends over time. RESULTS: There was no significant difference in ß-band LFP amplitude between initial electrode implantation (OR) and 3-week post-OR times (P=.94). However, ß-band amplitude was lower at implanted programmable generator replacement times than in OR (P=.008) and post-OR recordings (P=.039). Impedance measurements declined over time (P<.001). CONCLUSION: Postoperative LFP activity can be recorded years after DBS implantation and demonstrates a similar profile in response to movement as during acute recordings, although amplitude may decrease. These results support the feasibility of constructing a closed-loop, patient-responsive DBS device based on LFP activity.