Economic impact of contact force sensing in catheter ablation for atrial fibrillation.

AIMS: The TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation (TOCCASTAR) clinical trial compared clinical outcomes using a contact force (CF) sensing ablation catheter (TactiCath) with a catheter that lacked CF measurement. This analysis links recorded events in the TOCCASTAR study and a large claims database, IBM MarketScan®, to determine the economic impact of using CF sensing during atrial fibrillation (AF) ablation. METHODS AND RESULTS: Clinical events including repeat ablation, use of antiarrhythmic drugs, hospitalization, perforation, pericarditis, pneumothorax, pulmonary edema, pulmonary vein stenosis, tamponade, and vascular access complications were adjudicated in the year after ablation. CF was characterized as optimal if greater than or equal to 90% lesion was performed with greater than or equal to 10 g of CF. A probabilistic 1:1 linkage was created for subjects in MarketScan® with the same events in the year after ablation, and the cost was evaluated over 10 000 iterations. Of the 279 subjects in TOCCASTAR, 145 were ablated using CF (57% with optimal CF), and 134 were ablated without CF. In the MarketScan® cohort, 9811 subjects who underwent AF ablation were used to determine events and costs. For subjects ablated with optimal CF, total cost was $19 271 ± 3705 in the year after ablation. For ablation lacking CF measurement, cost was $22 673 ± 3079 (difference of $3402, P < .001). In 73% of simulations, optimal CF was associated with lower cost in the year after ablation. CONCLUSION: Compared to ablation without CF, there was a decrease in healthcare cost of $3402 per subject in the first year after the procedure when optimal CF was used.

REFINE (REducing Falls in In-patieNt Elderly) using bed and bedside chair pressure sensors linked to radio-pagers in acute hospital care: a randomised controlled trial.

BACKGROUND: falls in hospitals are a major problem and contribute to substantial healthcare burden. Advances in sensor technology afford innovative approaches to reducing falls in acute hospital care. However, whether these are clinically effective and cost effective in the UK setting has not been evaluated. METHODS: pragmatic, parallel-arm, individual randomised controlled trial of bed and bedside chair pressure sensors using radio-pagers (intervention group) compared with standard care (control group) in elderly patients admitted to acute, general medical wards, in a large UK teaching hospital. Primary outcome measure number of in-patient bedside falls per 1,000 bed days. RESULTS: 1,839 participants were randomised (918 to the intervention group and 921 to the control group). There were 85 bedside falls (65 fallers) in the intervention group, falls rate 8.71 per 1,000 bed days compared with 83 bedside falls (64 fallers) in the control group, falls rate 9.84 per 1,000 bed days (adjusted incidence rate ratio, 0.90; 95% confidence interval [CI], 0.66-1.22; P = 0.51). There was no significant difference between the two groups with respect to time to first bedside fall (adjusted hazard ratio (HR), 0.95; 95% CI: 0.67-1.34; P= 0.12). The mean cost per patient in the intervention group was £7199 compared with £6400 in the control group, mean difference in QALYs per patient, 0.0001 (95% CI: -0.0006-0.0004, P= 0.67). CONCLUSIONS: bed and bedside chair pressure sensors as a single intervention strategy do not reduce in-patient bedside falls, time to first bedside fall and are not cost-effective in elderly patients in acute, general medical wards in the UK. TRIAL REGISTRATION: isrctn.org identifier: ISRCTN44972300.

The TECH@HOME study, a technological intervention to reduce caregiver burden for informal caregivers of people with dementia: study protocol for a randomized controlled trial.

BACKGROUND: It is estimated that global dementia rates will more than triple by 2050 and result in a staggering economic burden on families and societies. Dementia carries significant physical, psychological and social challenges for individuals and caregivers. Informal caregiving is common and increasing as more people with dementia are being cared for at home instead of in nursing homes. Caregiver burden is associated with lower perceived health, lower social coherence, and increased risk of morbidity and mortality. The aim of this trial is to evaluate the effects of information and communication technology (ICT) on caregiver burden among informal caregivers of people with dementia by reducing the need for supervision. METHODS/DESIGN: This randomized controlled trial aims to recruit 320 dyads composed of people with dementia living in community settings and their primary informal caregivers. In the intervention group, people with dementia will have a home monitoring kit installed in their home while dyads in the control group will receive usual care. The ICT kit includes home-leaving sensors, smoke and water leak sensors, bed sensors, and automatic lights that monitor the individual's behavior. Alerts (text message and/or phone call) will be sent to the caregiver if anything unusual occurs. All study dyads will receive three home visits by project administrators who have received project-specific training in order to harmonize data collection. Home visits will take place at enrollment and 3 and 12 months following installation of the ICT kit. At every home visit, a standardized questionnaire will be administered to all dyads to assess their health, quality of life and resource utilization. The primary outcome of this trial is the amount of informal care support provided by primary informal caregivers to people with dementia. DISCUSSION: This is the first randomized controlled trial exploring the implementation of ICT for people with dementia in a large sample in Sweden and one of the first at the international level. Results hold the potential to inform regional and national policy-makers in Sweden and beyond about the cost-effectiveness of ICT and its impact on caregiver burden. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02733939 . Registered on 10 March 2016.

Implantable telemetric pressure measurement.

Highly miniaturised implantable pressure sensors can be used for wireless monitoring of different therapeutic procedures. This article presents an outlook on the market potential of these systems.

How to beat the high pressure cost.

Low cost, enclosed, silicon wafer pressure transducers have recently been introduced on the market in physiological ranges. This paper describes one family of these devices and describes an electronic circuit to interface these devices to a chart recorder or other high-level recording device.

Measurement of neuromuscular blockade--a comparison between a new "homemade" force displacement transducer and the accelerometer.

Train-of-four (TOF) ratios are compared between a new homemade force pressure transducer and a commercially available accelerometer. Twenty adult patients were studied and 600 simultaneous TOF ratio pairs were recorded during anaesthesia with varying degrees of muscle relaxation. Laboratory testing revealed that the output from the homemade device was linear up to 900 g and that there was a linear relationship between the output from the new device and the accelerometer (y = 0.802x + 5.167, R = 0.943, t = 69, P < 0.0001). Although the homemade device underestimates the accelerometer TOF ratio by 20%, it is a reliable and economic alternative to commercially available products for measuring TOF ratios.

Clinical comparison of the Spiegelberg parenchymal transducer and ventricular fluid pressure.

The Spiegelberg brain pressure catheter is a low cost implantable intracranial pressure measuring system which has the unique ability to perform regular automatic zeroing. A new version of the catheter has become available with a subdural bolt fixation to allow insertion of the device into the brain parenchyma. The accuracy of this system has been evaluated in comparison with a ventricular fluid pressure method in a series of patients to determine its accuracy and utility in the clinical environment. Hourly readings from the Spiegelberg system have been compared with those obtained using a standard pressure transducer connected to an external ventricular drain. Measurements continued while there was a clinical need for CSF drainage. Eleven patients were recruited to the study and data were recorded for periods ranging from 40 to 111 hours. A good agreement between the two systems was obtained. In 10 cases the mean difference was less than +/-1.5 mm Hg and the dynamic changes in value were contemporaneous. In one case an intracerebral haemorrhage developed around the tips of the Spiegelberg catheter and significant differences occurred between the two methods of measurement. In conclusion, the Spiegelberg parenchymal transducer provides an accurate measurement of intracranial pressure when compared with ventricular pressure. The transducer was found to be robust in the clinical environment and very popular with the nursing staff. Further studies may determine whether the complication rate of this system is comparable with other available devices.

Intracranial pressure monitoring techniques.

In patients requiring ICP monitoring, a ventricular catheter connected to an external strain gauge transducer or catheter-tip pressure transducer device is the most accurate and reliable method of monitoring ICP, and enables therapeutic CSF drainage. Clinically significant infections or hemorrhage associated with ICP devices causing patient morbidity are rare and should not deter the decision to monitor ICP. Parenchymal catheter-tip pressure transducer devices measure ICP, similar to ventricular ICP pressure, but have the potential for significant measurement differences and drift due to the inability to recalibrate. These devices are advantageous when ventricular ICP is not obtained or if there is obstruction in the fluid coupling. Subarachnoid or subdural fluid-coupled devices and epidural ICP devices are currently less accurate.