Remote vs in-Person Monitoring for ICD Follow-Up
One hundred and two study sites enrolled 1450 patients from November 2005 to February 2008. 56.9% of sites had used HM for ≥1 year, and 25.5% were HM-naïve within 90 days of first enrolment. One hundred and eighty-five (12.8%) of patients were followed in academic centres and 1265 (87.2%) in community hospitals. Nine hundred and seventy-seven patients were enrolled in HM vs. 473 in Conventional care. Of these, 824 (84.3%) in HM received a 3 month follow-up evaluation compared with 401 (84.7%) in Conventional care (P = 0.88; Figure 2). In HM, 94.6% of these remote evaluations were followed by IPEs but, in 46 of 824 (5.6%) cases, only remote checks were performed since patients failed to show (protocol deviation). Eighty-four HM and 30 Conventional patients did not have a 3 month evaluation but had at least one follow-up during the course of the study (P = 0.15). 7.1% HM and 8.9% Conventional patients never followed after enrolment (P = 0.25).
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Figure 2.
Conventional vs. Home Monitoring success rates compared.
Of enrolled patients, 908 of 977 (92.9%) HM and 431 of 473 (91.1%) Conventional patients completed at least one scheduled follow-up at some time point during the trial (P = 0.25). Patient characteristics in these groups were similar, though ischaemic heart disease was slightly more prevalent in Conventional ( Table 1 ). Mean time from implant to first office visit was 104 ± 65 days in HM vs. 99 ± 44 days in Conventional (P = 0.21). Mean follow-up durations were 407 ± 103 (range 21–617) days for the HM group and 399 ± 111 (range 32–582) days for Conventional (P = 0.17). Mean follow-up times were <15 months because of the ±30 day allowable window around the 15 month visit and subjects who withdrew during the study. Mortality rate did not differ between groups over 15 months of follow-up [HM vs. Conventional: n = 36 (4.0%) vs. n = 21 (4.9%), P = 0.47]. Patient attrition (withdrawal and lost to follow-up) during this 15 month period with Conventional care was 87 of 431 (20.1%) compared with 129 of 908 in HM (14.2%, P = 0.007), i.e. HM improved patient retention significantly. This was not due to distance from the clinic: 15.9% (22 of 138) of HM patients residing ≥50 miles away exited compared with 22.1% (15 of 68) of Conventional (P = 0.34), and if ≥60 min from clinic 18.9% (18 of 95) HM vs. 21.2% (7 of 33) Conventional subjects exited the study (P = 0.80).
Scheduled checks were completed more often in HM. There was 100% adherence to the five appointed checks (3, 6, 9, 12, and 15 months) in 542 (59.7%) of HM vs. 204 (47.3%) in Conventional patients (P < 0.001). Similarly, when considering the year following the initial 3 month evaluation during which HM patients were completely remotely managed, there was 100% adherence to the four appointed checks (6, 9, 12, and 15 months) in 568 (62.6%) of HM vs. 212 (49.2%) in Conventional patients (P < 0.001; Figure 2). Thus, HM secured a >25% greater adherence to all recommended follow-up evaluations. 93.5% HM vs. 90.7% Conventional (P = 0.07) patients were evaluated at least once more until trial conclusion but 59 (6.5%) HM patients vs. 40 (9.3%) (P = 0.07) Conventional patients failed to have any further scheduled interrogations. When accounting for patient attrition due to death, withdrawal, and lost to follow-up, overall adherence to all five possible scheduled follow-up evaluations remained higher in HM (3759 of 4056, 92.7%) vs. Conventional (1648 of 1847, 89.2%) (P < 0.001). Moreover, 32% of follow-ups in HM vs. 29% in Conventional occurred within 7 days of the appointment (P = 0.028), and 54.0 vs. 50.3% (HM vs. Conventional) within 15 days (P = 0.012), i.e. punctuality was better maintained by HM relative to the ±30 day window of the assigned follow-up date.
The two follow-up mechanisms were directly compared between 3 and 15 month time points when scheduled evaluations were exclusively in-person in Conventional and remote in HM for a full 1 year. The incidence of failed scheduled follow-ups at 6, 9, and 12 month time points in these respective study arms were 145 of 1098 (13.2%) in Conventional contrasting with 146 of 2421 (6.0%) in HM (P < 0.001). Home Monitoring advantage was observed consistently at each individual time point (Figure 3). Thus, Conventional management was associated with more than two-fold greater loss of adherence, indicating that patient-dependent mechanisms were more prone to failure.
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Figure 3.
Rates of failed calendar-based evaluations in remote-only vs. conventional care between 3 and 15 months, i.e. at 3, 6, and 9 months, and total [right —146 of 2421 (6%) in Home Monitoring vs. 145 of 1098 (13.2%) with conventional].
HM-based follow-up method was examined further. Daily transmission success was high. Time to first transmission was median 1 day after enrolment. Thereafter, overall success per patient was 91% during a median follow-up of 434 days, and daily HM transmissions were received in 315 795 of a potential 363 450 days (87%). The reason for failure of scheduled remote checks was most often due to oversight from the following facility (Figure 4, top). When accounting for this, transmission loss as a cause for failed 6, 9, and 12 month remote-only follow-ups (i.e. during the 1 year period when follow-up was completely dependent on technology reliability) was only 22 of 2275 (0.97%). Altogether, over the 15 months of the trial, 55 of 3759 (1.46%) of scheduled evaluations in HM were unsuccessful due to transmission loss. These occurred in 49 of 908 (5.4%) individuals, i.e. most losses occurred only once in any affected patient, in whom other scheduled transmissions remained successful. In these, last updated transmission occurred at a median time of 36 days prior to 'failed' scheduled check, i.e. relatively recently refreshed data still remained available for assessment. Transmission was reinstated within a median interval of 1 day after discovery (Figure 4, bottom).
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Figure 4.
(Top) Reasons for failed Home Monitoring checks during all vs. remote-only (6, 9, and 12 month) appointments. Clinic oversight was dominant. Transmission loss was infrequent, but when responsible for 'unsuccessful follow-up', (Bottom) last transmission available occurred a median of 36 days prior (left), and (right) after discovery corrected promptly (median 1 day).
In HM, trial design specified that remote evaluation be performed prior to yearly scheduled in-person visit. However, protocol deviation occurred in 97 of 1484 (6.5%) of 3 and 15 month visits because in-person visits failed. In all of these cases, the availability of automatically acquired up-to-date HM data permitted satisfactory remote-only evaluation, i.e. HM supported 100% of these scheduled evaluations. Notably, compulsory scheduled IPEs failed more often in Conventional (193 of 1841 of 3, 6, 9, 12,+15 month time points, P < 0.001, Figure 5).
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Figure 5.
Failure rate of mandated in person follow-up was 6.5% (97 of 1484 of 3 and 15 month time points) in Home Monitoring contrasting with 10.5% (193 of 1841) in Conventional (3, 6, 9, 12, and 15 months), i.e. 62% greater in Conventional.
Results
One hundred and two study sites enrolled 1450 patients from November 2005 to February 2008. 56.9% of sites had used HM for ≥1 year, and 25.5% were HM-naïve within 90 days of first enrolment. One hundred and eighty-five (12.8%) of patients were followed in academic centres and 1265 (87.2%) in community hospitals. Nine hundred and seventy-seven patients were enrolled in HM vs. 473 in Conventional care. Of these, 824 (84.3%) in HM received a 3 month follow-up evaluation compared with 401 (84.7%) in Conventional care (P = 0.88; Figure 2). In HM, 94.6% of these remote evaluations were followed by IPEs but, in 46 of 824 (5.6%) cases, only remote checks were performed since patients failed to show (protocol deviation). Eighty-four HM and 30 Conventional patients did not have a 3 month evaluation but had at least one follow-up during the course of the study (P = 0.15). 7.1% HM and 8.9% Conventional patients never followed after enrolment (P = 0.25).
(Enlarge Image)
Figure 2.
Conventional vs. Home Monitoring success rates compared.
Of enrolled patients, 908 of 977 (92.9%) HM and 431 of 473 (91.1%) Conventional patients completed at least one scheduled follow-up at some time point during the trial (P = 0.25). Patient characteristics in these groups were similar, though ischaemic heart disease was slightly more prevalent in Conventional ( Table 1 ). Mean time from implant to first office visit was 104 ± 65 days in HM vs. 99 ± 44 days in Conventional (P = 0.21). Mean follow-up durations were 407 ± 103 (range 21–617) days for the HM group and 399 ± 111 (range 32–582) days for Conventional (P = 0.17). Mean follow-up times were <15 months because of the ±30 day allowable window around the 15 month visit and subjects who withdrew during the study. Mortality rate did not differ between groups over 15 months of follow-up [HM vs. Conventional: n = 36 (4.0%) vs. n = 21 (4.9%), P = 0.47]. Patient attrition (withdrawal and lost to follow-up) during this 15 month period with Conventional care was 87 of 431 (20.1%) compared with 129 of 908 in HM (14.2%, P = 0.007), i.e. HM improved patient retention significantly. This was not due to distance from the clinic: 15.9% (22 of 138) of HM patients residing ≥50 miles away exited compared with 22.1% (15 of 68) of Conventional (P = 0.34), and if ≥60 min from clinic 18.9% (18 of 95) HM vs. 21.2% (7 of 33) Conventional subjects exited the study (P = 0.80).
Scheduled checks were completed more often in HM. There was 100% adherence to the five appointed checks (3, 6, 9, 12, and 15 months) in 542 (59.7%) of HM vs. 204 (47.3%) in Conventional patients (P < 0.001). Similarly, when considering the year following the initial 3 month evaluation during which HM patients were completely remotely managed, there was 100% adherence to the four appointed checks (6, 9, 12, and 15 months) in 568 (62.6%) of HM vs. 212 (49.2%) in Conventional patients (P < 0.001; Figure 2). Thus, HM secured a >25% greater adherence to all recommended follow-up evaluations. 93.5% HM vs. 90.7% Conventional (P = 0.07) patients were evaluated at least once more until trial conclusion but 59 (6.5%) HM patients vs. 40 (9.3%) (P = 0.07) Conventional patients failed to have any further scheduled interrogations. When accounting for patient attrition due to death, withdrawal, and lost to follow-up, overall adherence to all five possible scheduled follow-up evaluations remained higher in HM (3759 of 4056, 92.7%) vs. Conventional (1648 of 1847, 89.2%) (P < 0.001). Moreover, 32% of follow-ups in HM vs. 29% in Conventional occurred within 7 days of the appointment (P = 0.028), and 54.0 vs. 50.3% (HM vs. Conventional) within 15 days (P = 0.012), i.e. punctuality was better maintained by HM relative to the ±30 day window of the assigned follow-up date.
The two follow-up mechanisms were directly compared between 3 and 15 month time points when scheduled evaluations were exclusively in-person in Conventional and remote in HM for a full 1 year. The incidence of failed scheduled follow-ups at 6, 9, and 12 month time points in these respective study arms were 145 of 1098 (13.2%) in Conventional contrasting with 146 of 2421 (6.0%) in HM (P < 0.001). Home Monitoring advantage was observed consistently at each individual time point (Figure 3). Thus, Conventional management was associated with more than two-fold greater loss of adherence, indicating that patient-dependent mechanisms were more prone to failure.
(Enlarge Image)
Figure 3.
Rates of failed calendar-based evaluations in remote-only vs. conventional care between 3 and 15 months, i.e. at 3, 6, and 9 months, and total [right —146 of 2421 (6%) in Home Monitoring vs. 145 of 1098 (13.2%) with conventional].
HM-based follow-up method was examined further. Daily transmission success was high. Time to first transmission was median 1 day after enrolment. Thereafter, overall success per patient was 91% during a median follow-up of 434 days, and daily HM transmissions were received in 315 795 of a potential 363 450 days (87%). The reason for failure of scheduled remote checks was most often due to oversight from the following facility (Figure 4, top). When accounting for this, transmission loss as a cause for failed 6, 9, and 12 month remote-only follow-ups (i.e. during the 1 year period when follow-up was completely dependent on technology reliability) was only 22 of 2275 (0.97%). Altogether, over the 15 months of the trial, 55 of 3759 (1.46%) of scheduled evaluations in HM were unsuccessful due to transmission loss. These occurred in 49 of 908 (5.4%) individuals, i.e. most losses occurred only once in any affected patient, in whom other scheduled transmissions remained successful. In these, last updated transmission occurred at a median time of 36 days prior to 'failed' scheduled check, i.e. relatively recently refreshed data still remained available for assessment. Transmission was reinstated within a median interval of 1 day after discovery (Figure 4, bottom).
(Enlarge Image)
Figure 4.
(Top) Reasons for failed Home Monitoring checks during all vs. remote-only (6, 9, and 12 month) appointments. Clinic oversight was dominant. Transmission loss was infrequent, but when responsible for 'unsuccessful follow-up', (Bottom) last transmission available occurred a median of 36 days prior (left), and (right) after discovery corrected promptly (median 1 day).
In HM, trial design specified that remote evaluation be performed prior to yearly scheduled in-person visit. However, protocol deviation occurred in 97 of 1484 (6.5%) of 3 and 15 month visits because in-person visits failed. In all of these cases, the availability of automatically acquired up-to-date HM data permitted satisfactory remote-only evaluation, i.e. HM supported 100% of these scheduled evaluations. Notably, compulsory scheduled IPEs failed more often in Conventional (193 of 1841 of 3, 6, 9, 12,+15 month time points, P < 0.001, Figure 5).
(Enlarge Image)
Figure 5.
Failure rate of mandated in person follow-up was 6.5% (97 of 1484 of 3 and 15 month time points) in Home Monitoring contrasting with 10.5% (193 of 1841) in Conventional (3, 6, 9, 12, and 15 months), i.e. 62% greater in Conventional.
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