4.1 Main results
Individualized medicine and patient-centered care together with patient’s empowerment are three important factors of contemporary healthcare [
1,
8‐
11]. In particular, in the treatment of recurrent and symptomatic AF, knowing the outcomes perceived by the patient and their relations with clinical outcomes may improve the care and the management of patients during follow-up clinical care. This current analysis demonstrated that (of 865 patients, 353 subjects in the App group and 512 in the No-App group) AF recurrence was found in 57/865 subjects with an annual rate 10.99% in the App group versus 7.36% in the No-App group which was statistically different. In total, 14,458 diaries were sent by 353 subjects in the App group and 77.1% reported a good health status and no AF-related symptoms. Conversely, the patients reported a bad health status in 3.6% of diaries, and bad health status was an independent predictor of AF recurrence during follow-up.
Some pilot study experiences in collecting PRO in patients with AF have been published [
12,
13]. Steinberg
et al. described a systematic AF PRO implementation in a tertiary-care electrophysiology clinic, assessing the feasibility of routine collection in the clinical practice deploying the questionnaires via electronic e-mail invitation to selected patients undergoing catheter ablation for AF [
13]. In our pivotal experience, the patients were invited to the centers to download an App onto their own smartphones and to answer to only five simple questions in order to collect the general health status and the presence of more common AF-related symptoms. The ICHOM working group proposed a standard set of patient-reported outcomes including these sub-domains (
i.e., Quality of Life, emotional functioning, physical functioning, exercise tolerance, symptom severity, ability to work, and cognitive functioning) [
14].
The capability to collect and measure outcomes of patients in a standardized manner and in the clinical practice is, on one hand, the key to improving the potential of value-based healthcare and to realizing a patient–centric approach towards medicine. However, new challenges related to hospital organizations, time consuming activities, and dedicated/trained personnel must be considered when viewing these novel patient approaches across the healthcare landscape (inclusive of economic costs and value). The use of an automatic App may be a practical method to reduce the burden on the healthcare personnel’s time; however, the full impact on the healthcare system still needs to be assessed. A cautionary example being the vast amount of ECGs that now have to be medically reviewed and archived as more patients monitor cardiac function (and in particular arrhythmia) through smartphone Apps. While these patient-centric approaches are novel and valuable, there is a need to balance the workload efforts with more traditional routes of care.
Moreover, the App could be provided to patients before the ablation procedure. This approach may facilitate better clinical patient diagnosis and management, including: 1) the measurement of frequencies of symptoms before the ablation procedure may help in stratifying patients; 2) a comparison of patient symptoms before and after the ablation procedure may facilitate a patient centric continued care guidance/metric; and 3) an ability to interact with patients before an ablation procedure (inclusive of links to find more information about the cardiac disease and treatment options) may drive more patient engagement and compliance to continued medical care. In our pilot study (presented here), we decided to use the App as a patient diary to detect AF-related symptoms in a more objective manner. For this reason, the presence and frequency of the symptoms were analyzed for only the time period following the ablation procedure. Nevertheless, the data were available in real time, and consequently, there was an opportunity to intervene and contact the patient immediately. Importantly, further studies are needed to understand which approach is the best and sustainable methodology.
In our pilot experience, the patients who accepted the usage of the App were more likely to be younger, to be men, and to have paroxysmal AF. Patients “empowerment and engagement” in collecting symptoms may also facilitate their disease management. Hussein
et al. developed a fully automated platform to collect PRO and evaluate its first clinical application in a prospective cohort of AF ablations [
15]. The study observed an increasing number of follow-up assessments and duration of follow-up, compared with routine care alone [
15]. In our study experience, the patients were requested to use the App as a diary. Consequently, during the follow-up, the EP was able to match physical examinations, drug assessments, and clinical exams with the trend(s) of the reported symptoms.
Importantly, we observed that in patients with AF recurrence, about half of the patients (46.5%) reported (in the daily diary) the answer “bad” as a feeling compared with 24.5 % of patients without AF recurrence (p=0.012). Moreover, “bad” daily feeling resulted an independent predictor of AF recurrence. It is surprisingly that the feeling “bad” status correlated with AF recurrence rather than cardiac symptoms, including palpitation. One of the reasons could be that after catheter ablation the patients could perceive symptoms differently. In particular, the perception of palpitations can change over the time [
16]. Also, palpitation can be caused by extra beats rather than AF, which is consistent with an overall reduction in AF-related symptom burden in those patients still experiencing general health symptoms. Our 1STOP Italian experience of patient management through the patient App started and had been conducted during the COVID-19 pandemic period. In Italy, since March 2020, severe restriction rules on mobility have been imposed to all citizens, and the whole healthcare national system was under an incredibly stress. For several months during 2020 and 2021, hospitals and medical centers had been dedicated to the care of COVID-19 patients, with cancellation of every non-urgent medical and surgical activities. Consequently, there was a loss of follow-up visits for patients with chronic heart diseases [
17‐
19]. During the pandemic period, we have also witnessed the increase of AF burden, in non-infected people, as shown by the experience on patients with cardiac implantable electronic device (CIEDs) [
20,
21], and in infected people hospitalized with COVID-19 [
22]. The use of new technologies, such as telemedicine, had mitigated the lack of outpatient visits, especially in people with CIEDs [
20,
21,
23].
However, all remote technologies (including MYCRYO APP) born, enhanced, or increased to meet the needs of social distancing, continue to be appreciated and used amongst our patients. In particular, nowadays, the remote technologies have become part of the clinical routine and have been integrated with traditional follow-up. Ultimately, our experience and the results may be influenced by the COVID-19 pandemic era, but we think that the experience made during this pandemic may improve patient management through the use of unique remote devices and services. The use of MYCRYOAPP in this study has been shown to detect clinical recurrences of AF to an even significantly greater extent than the usual management without the use of the App (10.99% vs 7.36% - p=0.007), thus showing that it can make an important contribution precisely in the COVID-19 era. To our knowledge, we are not aware of other experiences using Apps during the COVID-19 pandemic period to monitor patients with heart diseases, but we consider that these technologies could be useful for this purpose of monitoring. In fact, the use of the App-based technology to collect symptoms has involved patients much more in the care of their own health and particularly in the management of their recurrences of AF, allowing a significant greater diagnostic power in regard to patients with standard follow-up.
Importantly, the bad feeling had a very high negative predictive value that could help in managing frequency and type of follow-up, especially during COVID-19 and the post-COVID pandemic time which we are currently treating. Moreover, the App-based technology could be implemented in the daily clinical practice in case of compliant patients to improve the quality of follow-ups collecting patient reported outcomes and managing the frequency of clinical examination, including ECGs, Holter monitoring, or/and drug therapies. Further randomized studies are needed to assess the impact of these new tools in the clinical practice.