CESC Workflow during COVID-19 Italian Lockdown
Among 3762 patients with a CIED, 425 (11.4%) patients had a single chamber implantable cardioverter defibrillator (ICD), 528 (14.0%) a dual chamber ICD, 95 (2.5%) a subcutaneous ICD in 95, 283 (7.7%) a cardiac resynchronization therapy (CRT) device, 231 (6.1%) a single-chamber pacemaker (PMK), 1472 (39.1%) a dual-chamber PMK, and 728 (19.3%) an implantable loop recorder (ILR). Of them, 662 (17.6%) patients were already in RM before COVID-19 outbreak.
A description of the CESC workflow is depicted in Figure 1.
Patients with an IPE scheduled between March and April 2020 were categorized into two groups: patients with a RM system prior to the lockdown (Group wRM ) and without a RM system (Group w/oRM).
-Group wRM: Scheduled IPEs for these patients were cancelled upon exclusion of any patient- and device-related issues assessed via a trans-telephonic contact and a device transmission performed within a week from the scheduled IPE appointment. For those reporting symptoms of HF or whose latest transmission documented a problem with system performance were followed up over the phone or, if necessary, scheduled for IPE.
-Group w/oRM: Patient without a RM system prior to the lockdown were further classified upon assessment of device features and compatibility for RM, individual clinical risk, and patient’s agreement.
Patients implanted with a CIED without RM capabilities or not willing to receive a RM system were classified by reviewing the available medical charts and over a screening trans-telephonic contact. Two groups were identified:
For “Low-Risk” patients the IPE was directly postponed within 6-9 months (long-term IPE) from the original in-hospital visit. Yet, a direct phone line with a team of specialized nurses was provided and patients were asked to report any new symptoms, emergency room visits or hospital admissions.
The remaining patients deemed being at “High-Risk” were scheduled for an IPE to be performed the same day or within one month from their original in-hospital examination.
Patients implanted with a CIED with RM capabilities and willing to receive the system were further categorized into two groups on the basis of RM system was assigned.
-Home-Delivered RM (Group hdRM): The device manufacturer agreed to provide the modem through a home delivery service. Once the modem was delivered, a specialized nurse contacted the patient in order to train and educate him/her on the use of the modem and to offer technical support when needed. A manual transmission within 24h was requested to verify the correct activation of the modem, and only once the patient successfully completed the transmission, the IPE scheduled for March or April was cancelled.
-Office-Delivered RM (Group odRM): A short-term IPE (the same day or within a month from the original in-hospital visit) was scheduled. During the appointment, the RM system was delivered and a specialized nurse was responsible for patient training and education. After discharge, the patient was asked to perform a manual transmission from home.
For all previous and new patients with RM, every nurse referred to a physician for informed consent submission and patient’s clinical management. Yet, a direct phone line with a team of specialized nurses was provided and patients were asked to report any technical issues with the system, as well as new symptoms, emergency room visits or hospital admissions. Compliance to drug therapy was monitored as well by phone contacts either periodically (monthly or bimonthly based on patient’s risk profile and medical history) or in case of event recurrences. Pharmacological therapy titration and clinical event management were discussed among the clinical staff and, when necessary, IPE or hospital admission were programmed according to the clinical status of the patient. A dedicated pathway was created for IPEs in order to guarantee patient’s safety.