Device therapy for the major complications detection and early treatment of patients with natural and iatrogenic comorbidities admitted to internal medicine wards
Authors: Pietrantonio F , Rosiello F , Pascucci M , Alessi E , Ciamei A , Cipriano E , Di Berardino A , Laurelli G , Porzano A , Delli Castelli M , Marino G , Onesti E , Montagnese F , Rainone M , Ruggeri M 
Published: October 2021

Abstract

Background
Whith advances in devices miniaturization and wireless technologies, wereable “on body” ECG patch devices are unobtrusive and easy to use. Continuous ECG monitoring in the short term is indicated in patients who, due to age, comorbidities and polytherapy, are at greater risk of arrhythmias. Since 2017, a randomized-open label study is being conducted at the admission of acute patients in Internal Medicine Unit for 72 hours with continuous monitoring of vital parameters and the 5 leads-ECG (VP-ECG CM) trace by the mean of a tele-cardiology program.

Purpose
Objective of this study is to perform a cost-effectiveness evaluation of the VP-ECG CM program in inpatient settings.

Methods
Data were used in order to evaluate costs, the program effectiveness and the QALY gains using wireless monitoring compared to nurses traditional one. Costs were estimated by mean of the identification, measuring and valorization of the resources uptake. Cost drivers included: time spent by personnel, cost of the device, consumables, medical treatments, diagnostic exams and complications. The perspective of the Italian National Health Service was adopted. The incremental analysis was performed in order to present the cost per complication avoided and the cost per QALY gained. Net monetary benefit was also calculated. Either a deterministic and probabilistic analysis were performed by means of a bootstrap simulation allowing for re-sampling. A cost-effectiveness-acceptability curve was estimated, considering a cost-effectiveness threshold of €35,000/QALY.

Results
On 143 patients, arrhythmias and acute coronary syndrome were detected 4.3% in the experimental arm and 1.9% in the control arm, whilst 29,5% major complications were detected in the experimental arm vs 43.5% in the control and reduction in the number of sudden deaths (16% control and 9.3% experimental). Time spent by nurses in the control arm (58 minutes/day/patient) was the most relevant cost driver and allowed a saving ranging €54–90/patient. This saving overwhelmed the costs for the equipment whilst the other costs remained unchanged, thus allowing for the VP-ECG CM to be dominant versus the standard of care. One way and multiway sensitivity analyses confirmed the robustness of our results with p-value 0,05 involved in the bootstrap presenting dominance of the VP-ECG CM.

Conclusions
Notwithstanding the concerns of a loss of control in patient management, telemedicine (digital health infrastructure and driver) could perform healthcare transformation enabling physicians to increase the volume of patients seen, reduce the time to diagnosis, improve efficiency and efficacy of disease management, and reduce unnecessary clinic visits and hospital admissions. The miniaturized technologies can improve patient adherence, and the detection, characterization and monitoring of cardiac arrhythmias – readily digitalized markers and phenotypes of cardiovascular disease.

Funding Acknowledgement
Type of funding sources: None. Wireless Monitoring Study flowchart