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:
- “Low-Risk” Group:
- CIED with a battery longevity ≥ 12 months estimated during an IPE
performed within the 6 months before study initiation;
- No device alerts detected during the last IPE performed within the 6
months before study initiation;
- No history of complex arrhythmias;
- No referred symptoms of acute decompensation and syncope.
- “High-Risk” Group:
- CIED with a battery longevity < 12 months estimated during
an IPE performed within the 6 months before study initiation;
- Abnormal lead impedance, threshold or sensing;
- Recent history (< 3 month) of acute heart failure
requiring hospitalization;
- Appropriate and inappropriate ICD therapy detected in the last IPE;
- New onset of acute decompensation symptoms or referred syncope.
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.