English databases (PubMed, Web of Science, Embase, and the Cochrane Library) and Chinese databases (CNKI, the VIP database, the Wanfang database, and the Chinese Biomedical Literature database) were searched for qualitative research on the life experience of patients after implantation of cardiovascular electronic devices. Although the first CIED was implanted in 1958 [21], with the development of medical technology and services, patients are currently facing completely different problems compared with patients implanted decades ago. Therefore, this study examines relevant papers published since the 21st century, with a specific period from January 2000 to August 2022. A combination of Medical Subject Headings (MeSH) terms and keywords, such as “Pacemaker, Artificial”, “Defibrillators, Implantable”, “Cardiac Resynchronization Therapy Devices”, “Life”, “Feel”, “Experience”, and “Qualitative Research” were used to conduct a comprehensive search of the above-mentioned databases. The retrieval strategies are shown in Table 1, using PubMed as an example. The current review was undertaken following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.

According to the PICoS principles, the inclusion criteria of papers were set as follows: (1) P (participant): aged 18 or over patients with a CIED; (2) I (phenomenon of interest): life experience of patients after CIED (PM, ICD, CRT) implantation; (3) Co (context): patient’s home or workplace, hospital or clinic; (4) S (study design): qualitative research, including phenomenological research, grounded theory, case study, ethnography, and action research. The exclusion criteria were as follows: (1) mixed population studies, qualitative data cannot be separated; (2) full text unavailable, incomplete data, and duplicate publications; (3) studies that were not in Chinese or English.

Two authors independently screened the articles, extracted the data, and cross-checked them in strict accordance with the inclusion and exclusion criteria. In case of disagreement, a third party assisted in the decision. When screening articles, duplicate documents were first removed using EndNote document management software. Subsequently, the title and abstract of each article were read and, after excluding irrelevant documents, the full text was read to determine whether an article was finally included in the analysis. The data extracted mainly included the author (country) year, the qualitative research method used, the research object, the phenomenon of interest, the location, and the main results.

Two authors independently evaluated the included articles according to the 2016 edition of the JBI Evidence-based Health Care Quality Evaluation Standards for Qualitative Research [22]. Using these criteria, each item is rated as “yes”, “no”, or “unclear”. If the criteria are fully met, then the possibility of bias is minimal, and the item is classified as grade A. If some of the above quality standards are met, then the possibility of bias is moderate, and the item is classified as grade B. The items that do not meet any of the above quality standards have a high possibility of bias and are classified as grade C. Once the quality of the articles had been independently evaluated, the results of the two authors were compared. In case of disagreement, the two authors sought to reach a consensus or asked a third party to decide whether to include the article after arbitration. Finally, studies with quality grades A and B were included, while those graded C were excluded.

Thomas and Harden’s thematic and content analysis methodology of synthesising qualitative studies was used to guide this meta-synthesis [22]. Before the synthesis, the included studies were read and reread by two authors to obtain a preliminary understanding. According to the first stage of thematic and content analysis, all results and findings were inductively coded line-by-line according to their meaning and content. In the second stage, these codes were grouped by comparing their similarities and differences to create descriptive themes. Finally, reread descriptive themes, and new conceptions, understandings, or assumptions were identified. In this stage, analytical findings (themes and subthemes) were generated that presented the key findings of the primary studies. The initial coding process was carried out by two authors. The identification of emergent descriptive themes and analytic themes was completed by one author. The data analysis process was subsequently checked by the whole research team to ensure the congruence of the interpretations and the adequacy of the analytic themes.

As shown in Fig. 1 and Table 2 (Ref. [10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 23, 24, 25, 26, 27, 28, 29, 30]), a total of 2117 articles were retrieved from the databases, and 18 were finally included after deduplication and screening [10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 23, 24, 25, 26, 27, 28, 29, 30]. Publication dates ranged from 2000 to 2022. The largest number of studies (n  =  4, 22.22%) was from Sweden, the UK, the USA, and Italy each had two studies, Australia, Netherlands, Norway, Spanish, China, Iran, Singapore, and Turkey each had one study. Across the articles, there were 301 patients. Their age ranged from 21 to 93 years old. Among them, 207 (68.77%) were male, 94 (31.23%) were female, 194 (64.45%) were married, 47 (15.61%) were single and others, the marital status of 60 (19.94%) people is unclear, 248 (82.39%) had ICD, 36 (11.96%) had PM, 17(5.65%) had cardiac resynchronization therapy-defibrillator (CRT-D). Of the 18 articles included, 7 were phenomenological studies [10, 12, 13, 14, 18, 23, 27], 5 were descriptive qualitative studies [11, 16, 24, 26, 28], 4 were grounded theory studies [15, 17, 19, 29], 1 was interpretive interactionism study [25], and 1 was deductive exploratory study [30].

Fig. 1.

Flowchart of the included studies.

As shown in Table 3 (Ref. [10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 23, 24, 25, 26, 27, 28, 29, 30]), the methodological quality evaluation results showed that 3 articles were grade A and 15 were grade B. Notably, only three studies clarified the potential influence of the researchers’ beliefs and values on the research, and only eight studies addressed the researchers’ influence on the research and the influence of the research on the researchers. In addition, ethical considerations were unavailable for one study.

Twelve key subthemes were extracted from the eighteen included studies. Through meta-synthesis, three themes were identified by comparing and contrasting the twelve subthemes. The lived experiences of patients implanted with CIEDs are categorized according to the following three themes: (1) equipment symbiosis; (2) external support; (3) self-coping. Both the descriptive and analytical findings are reported in the following sections.

The results of this study show that while CIED helps patients fight the disease, it also brings physical discomfort to patients. Therefore, it is necessary to reduce the physical discomfort caused by CIED to patients by reducing the size of the device, reducing the number of unnecessary electric shocks, and extending the battery life of the device. The reason is, the size of the device affects the degree of foreign body intrusion that the patient feels [18], while unnecessary electric shocks can cause anxiety and pain, and even lead to patients giving up using their CIEDs [31]. Extended battery life can reduce the number of battery replacements, the risk of infection and device damage or failure, and treatment costs [31]. Regarding how to improve the patient’s acceptance of the device size, previous studies have shown that it can be achieved by optimizing the design so that the skin pressure is evenly distributed on the surface [32]. Regarding how to reduce unnecessary electric shocks, studies have shown that it can be achieved through antitachycardia pacing (ATP) [33]. ATP is an effective method for reducing electric shock and can prevent more than 50% of electric shock-induced pain [33]. In particular, intrinsic ATP (iATP) can provide adaptive ATP therapy that responds to the tachycardias of individual patients, terminating 87.8% of ventricular tachycardial episodes [34]. Regarding how to prolong battery life, studies have shown that using high-density integrated circuits and low-energy Bluetooth transmission can reduce quiescent current consumption by 9% [31]. Using chemical techniques can increase the battery capacity by 14% without a concomitant increase in battery size [31]. However, whether these achievements can play a role in the clinic and be widely applied still needs to be determined through continuous and comprehensive equipment monitoring and multi-center clinical trials. Additionally, developing industry-wide standards for predicting and reporting battery life and current drain measurements remains a formidable challenge, and meeting this challenge requires accelerated technological innovation.

The results of this study show that patients have a strong need for external support after CIED implantation. Accordingly, it is necessary to build a support system led by medical staff, with the participation of peers, family members, and society, to help patients better adapt to life post-implantation. Both our and previous studies have shown that during office visits, medical staff needs to strengthen communication with patients to increase patient trust [11, 14]. At the same time, consider individual differences among patients, and provide patients with life guidance and information on exercise rehabilitation, driving restrictions, and equipment discontinuation to enhance the self-management capabilities of patients after CIED implantation [11, 14, 17, 35]. Improved patient outcomes have been associated with positive psychological constructs. For patients with anxiety, fear, and self-doubt, psychological intervention methods, such as cognitive behavioral therapy, quality-of-life therapy, and mindfulness therapy, can effectively promote positive emotions and improve their psychological status [36, 37, 38]. This is conducive to helping patients correctly understand themselves and face the future positively. Simultaneously, setting up support groups can strengthen communication among patients and help them obtain peer support [23]. Therefore, outside of visits, patients need to actively cooperate with their healthcare provider’s psychological interventions and participate in support groups. In addition, caregivers may lack confidence due to a lack of care experience, and medical staff also need to provide them with personalized guidance to improve the care level, thereby promoting patient recovery [39]. Family members should also avoid overprotecting patients and encourage them to actively participate in family activities and take on family responsibilities within their abilities, thereby helping them to regain their sense of value in family roles. Society needs to be more accepting of these patients. In addition, patients must be encouraged to actively participate in social activities, given re-employment opportunities, and helped return to society. Last but not least, healthcare providers can use follow-up visits to see if the patient’s support needs are being met and what needs to be improved.

The results of this study show that the uncertainty of CVD prognosis results in a strong demand for continuous care after discharge [12]. Studies have found that CIED remote monitoring can not only help patients detect arrhythmias and equipment failures in time [40] but also quickly detect electric shock events and clinical adverse events [41]. This not only improves patient safety, reduces the number of hospitalizations [42], reduces all-cause hospitalization and mortality rates [43], but also reduces the uncertainty of CVD prognosis [40, 41, 42, 43]. Remote monitoring has been practiced and adopted to varying degrees for decades, but there is much to be improved in terms of patient access and needs. Chew et al. [44] (2022) refer to despite expert recommendations advocating the use of remote monitoring of cardiac implantable electronic devices, implementation in routine clinical practice remains modest due to inconsistent funding policies across health systems. In addition, Daley et al. [45] (2020) refer to patients who either do not have access to remote CIED monitoring data or require professional assistance in reading and interpreting the data. Fraiche et al. [46] (2021) refer to patients who also want the ability to integrate individual preferences into remote monitoring alarm systems so that they can choose how the alarm is handled for a better experience. Accordingly, it is necessary to increase financial investment to improve the reimbursement system, develop patient-centered remote monitoring applications, and carry out remote monitoring education and training for patients, to meet their needs for self-health control.