Subgroup Characterization, RM Coverage and Distribution, and Study
Endpoint
Among 1114 CIED patients, 265 (23.8%) were already in RM (Group
wRM ). RM eligibility was checked for the remaining 849 (76.2%)
patients not in RM (Group w/oRM ). Five hundred seventeen (60.9%)
patients were ineligible for RM owing to connectivity or
device-compatibility issues. Therefore, individual risk assessment was
performed: a long-term IPE was scheduled for 423 (81.8%) “Low-Risk”
patients, whereas 94 (18.2%) patients were deemed being at
“High-Risk” and scheduled for a short-term IPE.
The remaining 332 patients implanted with a CIED with RM capabilities
(Table 2) were further categorized into two groups on the basis of the
modality the new RM system was assigned. In 229 (69.0%) patients, the
modem was directly delivered home (Group hdRM) whereas in 103
(31.0%), modem was assigned during an in-office visit (Group
odRM).
Starting March 1st, 229 RM devices were shipped to
each patient’s home address (Group hdRM ). Mean delivery time was
2.8 ± 1.1 days and by March 15th all hdRM patients had
received the modem.
In Group odRM (n=103), an in-office visit was scheduled within an
average of 4.2 ± 1.4 days from the date of the original IPE. A dedicated
pathway was created to guarantee patient’s safety. Therefore, maximum 8
patients per day were scheduled and follow-ups were carried out in two
different rooms. None of the patients, family members, or healthcare
workers being affected by the virus during the 2-month study period. By
March 27th all Group odRM patients had received
the device for RM.
Among the 332 patients who received the modem either at home or during
an in-office visit, RM Activation Time was <24h in 271
(81.6%) patients, between 24h and 48h in 36 (10.8%), between 48h and
72h in 14 (4.2%), and >72h in 11 (3.3%). RM Activation
Time within 24h was significantly lower in patients older than 75 years
old (73.2% vs 88.2% in patients < 75-year-old; p <
0.01) and in patients living alone (81.5% vs 89.4% in patients not
living alone; p < 0.01).
No significative differences in RM activation time were documented
between Group hdRM and Group odRM . The mean AT was 1.33 ±
0.83 days in Group hdRM and 1.28 ± 0.81 days in Group odRM(p=0.60). Specifically, a first manual transmission within 24 hours was
recorded in 186 (81.2%) patients from Group hdRM and 87 (84.5%)
patients from Group odRM (p=0.47; Figure 2)
However, a trend toward a higher number of trans-telephonic technical
support contacts due to problems completing the first transmission was
observed in Group odRM [4 (4.2%) patients vs 21 (9.9%)
patients; p=0.09]. Moreover, 2 patients per group required a new IPE
(0.9% vs 2%; p=0.59); in one case a modem manufacturing defect was
detected.