The medical environment in Asian Pacific countries
The medical environment in Asian-Pacific countries is widely different from that in Western countries in terms of disease prevalence, CIED implant rates, and other parameters. Moreover, there are remarkable differences in the manner patients are followed-up among the countries in the Asian-Pacific region . In particular, the role of RM may differ in Japan owing to its dense population and developed transportation networks in most cities. RM was tentatively introduced in Japan in 2008, and the reimbursement system was launched in April 2010. Initially, there was a concern that Japanese patients, who prefer face-to-face visits, would not accept the RM system. Accordingly, a feasibility study of CareLink Monitor by Ando et al.  enrolled a total of 203 patients who had previously undergone CIED implantation at 5 Japanese centers. A total of 470 transmissions were made. Questionnaires were completed by patients and physicians to evaluate acceptance, ease of use, and satisfaction with the system. More than 87% of the patients felt that the monitor was easy to use, and nearly all of the physicians were satisfied with the system. The majority of the patients felt reassured by having their devices remotely assessed and preferred less frequent hospital visits made possible by the monitor. Thus, the CareLink RM device was well accepted by both the patients and physicians in Japan. As mentioned before, currently all 5 manufacturers have developed their own RM systems for ICDs and CRT-Ds, and most of them support PPMs. The methods of data transmission vary, and the patients׳ acceptance may differ depending on the system. However, it seems that all systems have been favorably accepted by Japanese patients.
RM has become a standard medical care for patients with CIEDs. However, some limitations and problems are still waiting to be solved. First, RM does not eliminate the necessity of in-hospital follow-up. It would be nearly impossible to detect events other than malfunctioning of the CIED system, arrhythmia, and JTP-74057 failure. As demonstrated by the Japanese HOME-ICD study , it is also inevitable that false-negative events sometimes occur. Nevertheless, according to the results of the previous studies, the interval between face-to-face visits for ICD/CRT-D patients can likely be increased from 3–4 months to 6–12 months in Japan, which will undoubtedly reduce the burden on patients and medical professionals . However, as shown by the REFORM trial , stretching the interval to 12 months may increase the number of patients who are lost to follow-up. Hence, an efficient follow-up system will be required to fully utilize the benefits of RM.
Emerging clinical evidence for RM Many larger studies and randomized trials have been recently reported. In particular, the ALTITUDE survival study by Saxon et al.  is a large multicenter survey of patients implanted with ICD and CRT devices across the United States. Within this study, outcomes were compared between patients followed in device clinic settings and those who regularly transmitted the data remotely at an average rate of 4 times per month. One- and 5-year survival rates in 185,778 patients after ICD implantation were 92% and 68%, respectively, whereas the corresponding rates for CRT-D device recipients were 88% and 54%. Remarkably, 1- and 5-year survival rates were higher in the 69,556 ICD and CRT-D patients receiving remote follow-up on the network than in the 11,622 patients who received device follow-up in device clinics only (50% reduction; P<0.0001). The TRUST trial reported by Varma et al.  was a prospective, randomized, multicenter clinical trial comparing the safety and usefulness of automatic daily RM in ICD recipients with standard in-clinic follow-up. In total, 1339 patients were randomized at a 2:1 ratio to RM or conventional follow-up. Follow-up checks occurred at 3, 6, 9, 12, and 15 months after implantation. At 6, 9, and 12 months, only RM was used as the follow-up for patients randomized to the RM group, but it was followed by office visits if necessary. RM reduced the total number of in-hospital device evaluations by 45% without affecting morbidity. In the RM group, 85.8% of all 6-, 9-, and 12-month follow-ups were performed remotely only. For all arrhythmic events, the median time to evaluation was less than 2 days in the RM group compared with 36 days in the conventional group (P<0.001).