Cardiovascular (CV) diseases remain the biggest health burden worldwide [1]. Telemedicine can be used to monitor diseases and treat patients in real time. Previous studies have shown that patients with CV diseases who received telehealth medicine had better control over vascular risk factors, such as hypertension, diabetes mellitus, and dyslipidemia [2]. Furthermore, both Spyros et al [3] and Sally et al [4] reported that telemedicine was an important prognostic factor for patients with congestive heart failure in reducing all-cause mortality Relatedly, we have shown that a fourth-generation telehealth program—more specifically, an internet-based, synchronized disease management program that provides an immediate response—is associated with lower all-cause mortality among patients with CV as compared to that seen in patients who did not participate in the program [5]. However, Takahashi et al [6] found that asynchronous telemonitoring did not lead to fewer hospitalizations or emergency department visits. Meanwhile, a review article suggested that telemedicine should be carefully evaluated and applied in only those patients who would really benefit from it in terms of improved clinical outcomes [7].

Patients with peripheral artery disease (PAD) have relatively high rates of various comorbidities, including acute coronary syndrome (ACS), stroke, and congestive heart failure [8-10]. Numerous cohort studies have reported that the clinical outcomes of PAD patients are grave, with the rates of major adverse CV events and mortality being higher among PAD patients than among the general population. Moreover, PAD is an independent risk factor for mortality in patients with CV diseases [11]. Current guidelines advocate the use of antiplatelet agents and statins as primary therapies for these patients to prevent further major adverse cardiovascular events, because they are at high risk of CV events [11,12]. Therefore, it is important to treat PAD patients using innovative modalities to improve their overall prognosis. New treatment strategies that offer better CV outcomes for these patients are needed in the internet era. The costs and CV benefits of the fourth-generation synchronous telehealth program for these patients remain unknown.

The aims of this study were to elucidate the effects of the fourth-generation synchronous telehealth program for PAD patients on their CV outcomes, including stroke, ACS, and hospitalization for heart failure; and to evaluate the medical costs for these patients, including those who are treated at outpatient clinics and emergency departments or who are hospitalized.

This is the first study to investigate the application of the fourth-generation synchronous telehealth program to patients with PAD in terms of various CV outcomes. Retrospectively, we found that the PAD patients who participated in the telehealth program had lower risks of both stroke and composite vascular events in the midterm follow-up but only a lower risk of stroke events over the long-term follow-up period. The vascular protection seemed most prominent in the first year, and this phenomenon then diminished in the following years with regular CV clinic visits. In the first year, 3 out of every 100 patients in the telemedicine group were free from stroke events. Otherwise, the total medical costs were comparable in both groups.

Telehealth care has been shown to reduce hospitalizations in patients with chronic conditions such as asthma, chronic obstructive pulmonary disease, and heart failure [17-20]. We have previously reported that better cost-effectiveness and clinical outcomes were noted with the use of fourth-generation synchronous telehealth program in patients with chronic CV diseases [13]. However, some other studies failed to show better clinical outcomes in patients taking part in telehealth programs [6,7]. This difference in the results could be explained by the enrollment of different types of patients and the implementation of different versions of telehealth programs. We previously reported that PAD was the remaining prognostic factor for CV admission in patients receiving telehealth care after multivariable Cox regression [21]. However, the costs and CV benefits of the fourth-generation synchronous telehealth program for PAD patients are still not well validated. In this study, we focused on those patients with PAD who had higher risks of grave CV outcomes such as myocardial infarction and stroke [22,23]. According to a previous study, the 5-year cumulative incidence of mortality among asymptomatic and symptomatic patients with PAD is 19% and 27%, respectively [24]. In the internet era, it is important to consider the speed of medical care responses of telehealth programs, especially with respect to high-risk patient groups. The early identification of PAD patients with optimized and comprehensive treatment is critical for improving clinical outcomes, and telehealth programs could be applied to PAD-related wound care or gangrene management in place of CV systems that provide comprehensive care [25,26]. In this study, we found that patients receiving telemedicine care had significantly lower rates of stroke events in the mid- and long-term follow-up periods than did the group that received normal care. As high blood pressure is a major cause of stroke, better control of blood pressure is essential to preventing stroke attacks. Lu et al [27] showed that the implementation of home telehealth care supervised by nursing managers improved blood pressure control in patients with high blood pressure. Furthermore, it was found that a mobile phone intervention could significantly reduce systolic blood pressure among patients with high blood pressure (mean difference of 4.3 mmHg) [28]. Digital health strategies were also found to have a beneficial effect on blood pressure control [29]. These findings suggest that the stroke prevention benefits of telemedicine may be linked to the better blood pressure control exhibited by patients using the telehealth program. On the other hand, the prevalence of carotid artery stenosis is high in patients with PAD [30]. Through good medication compliance, the early management of CV risk factors, and the prompt detection of clinical arrhythmia, full-time nursing case managers and cardiologists who provide round-the-clock care are also able to reduce the risk of stroke among those patients with PAD that have carotid artery stenosis.

In this study, we found that, in the midterm, the fourth-generation synchronous telehealth programs improved the composite vascular outcome (including acute coronary syndrome and stroke) of patients with PAD. This vascular protection was most prominent in the first year and gradually diminished over the years that followed as confirmed through the regular follow-up visits at CV clinics. The telehealth program seems to bridge the transition from hospital admission to home care. Therefore, the proper timing for initiating telehealth is just as important as the timing for taking medication. The conditions of patients with CV disease deteriorated rapidly just after their discharge [31,32]. Our study supports the notion that the optimal timing for implementing a telehealth program for patients with PAD is at the time of discharge from hospital.

Those patients with PAD who took part in the telehealth program in this study had 2.99 fewer stroke events and 1.86 fewer composite vascular events per 100 patients in the first year than did the control group patients. As the prevalence and incidence of patients with PAD is high, the number of patients needed to be treated with telehealth program can be easily achieved in clinical practice. As patients participating in telehealth programs will have to pay additional fees, the costs and benefits associated with this program should be analyzed. We found that the medical costs of the telehealth program patients in this study were not greater than those of the control group, in spite of the fact that they did have better clinical outcomes in terms of stroke and composite vascular events. This finding suggests that the participation of PAD patients in the telehealth programs can also confer economic benefits. Moreover, opportunity costs other than medical ones should also be considered. Because patients with PAD suffer from grave CV outcomes, they are more likely to lose their jobs and to pay higher insurance premiums. In the United States, individuals diagnosed with PAD face higher health care–related expenditures and out-of-pocket expenses compared to healthy adults [33]. Therefore, the total expenditure of patients with PAD and stroke is likely higher than that revealed in our study.

This study had several limitations. First, the study was not randomized, which resulted in the heterogeneity of the patient population and disease severity. However, we performed IPTW matching of 2 groups with balance to minimize the possible confounding effect of clinical factors. Second, the outcome of amputation was not coded in our cohort. In addition, although we did show the composite vascular outcome in our analysis, this outcome is particularly important in patients with PAD and should be clarified in a future study. Third, the clinical outcomes were derived from the electronic billing and medical records of our hospital, and the data for patients who received care outside of our hospital were not recorded. Resources that were used but not billed might have also been overlooked when extracting data from our billing system.

Those patients with PAD who participated in the fourth-generation telehealth program exhibited a lower risk of stroke events over both short- and long-term follow-up periods than did the control group. In addition, the total medical costs of the 2 groups were comparable, with no significant difference being found. Further randomized trials are needed, however, to confirm our findings and guide clinical practice.