Beyond nursing programming: preventing adverse events in patients with implantable cardiac devices undergoing invasive procedures and MRI after lean healthcare method
Authors: Flores Soler J , Garcia Gonzalez F , Casas De La Cal L , Herreros Gil M , Salgado Aranda R , Perez-Castellano N , Perez-Villacastin Dominguez J 
Published: May 2022

Abstract

Funding Acknowledgements
Type of funding sources: None.

Introduction
Follow-up in patients with cardiovascular implantable electronic devices (CIED) is essential to avoid adverse events and complications, such as arrhythmias, device dysfunction, and infections, among other events. Prevention plays a fundamental role, especially when these patients undergo non-cardiological invasive tests and/or procedures (e.g., surgeries) or magnetic resonance imaging (MRI). These situations sometimes require the reprogramming of the device. In our Arrhythmia's Unit, after developing a healthcare management model based on the Lean methodology, 2 processes were identified that implied a reduction in activity, a threat to efficiency and a risk to patients who would undergo invasive non-cardiological procedures or MRI. One of them was a significant number of "urgent" consultations and calls to evaluate and/or reprogram CIED in patients that underwent invasive non-cardiological procedures the same day, many of them without indication of reprogramming according to the type of procedure. Another one was the increase in consultations of people with CIED who require MRI, was often contraindicated because it produces adverse effects on the patient and/or device. Objectives: To implement action protocols, depending on the type of device and dependant on stimulation, for patients with CIED who undergo surgery and invasive non-cardiac procedures and MRI. To evaluate the number of urgent calls and adverse events before and after implementation. Methods: A single-centre, not randomized study has been designed. A year before and after the implementation of the protocol the following variables were quantified a) number of urgent calls b) number of adverse events (persistence of the special programming of the device more than 24 h after the end of the procedure: asynchronous stimulation, ICD therapies off, CIED dysfunction or unnecessary programming). Two protocols were developed: a) management of CIED carriers undergoing invasive non-cardiological procedures according to recent clinical practice guidelines. b) risk of dysfunction after MRI based on type/compatibility with MRI of the device, implanted leads, and stimulation dependence, using a colour scale, from safe (in green) to high risk of dysfunction (in black) Pictures 1,2. The protocols for action in the anaesthesia and radiology services were disseminated through sessions given by the arrhythmia unit staff. Results: In the year prior to implementing the protocol, 185 urgent calls/year were quantified, (15.1 calls/month) and the number of adverse events was 4 (0.2 events/month). One year after the implementation of the protocol, urgent calls were reduced to 4calls/year, representing 0.33 calls/month (p &lt;0.001) and there was an absence of adverse events (zero events/month). Conclusions. The implementation of protocols based on recent clinical practice guidelines can reduce urgent calls and adverse events related to reprogramming in our centre, thus increasing patient safety.