Florida Patient Acceptance Survey Research Articles

How do illness perceptions impact device acceptance in patients with an implantable cardioverter defibrillator?

Abstract Background The implantable cardioverter defibrillator (ICD) is the first-line treatment for the prevention of sudden cardiac death in patients at high risk of a life-threatening arrhythmia. Illness perceptions encompass the cognitive and emotional representations each ICD patient has about their health condition, thus influencing coping strategies and health behaviors essential to adjusting to life with their device and underlying heart disease. We investigate how illness perceptions are prospectively linked to device acceptance in ICD patients. Purpose To examine how illness perceptions at ICD implantation are associated with patient device acceptance one-year post-implantation. Methods Secondary analysis of the ACQUIRE-ICD, national, multi-center, randomised controlled trial. Illness perceptions were measured with the Brief Illness Perceptions Questionnaire (B-IPQ) with 350 first-time ICD or cardiac resynchronization therapy defibrillator (CRT-D) recipients filling out the questionnaire at ICD implantation. B-IPQ was only assessed at baseline. Patient device acceptance, a disease-specific quality of life measure for ICD patients, was measured at both ICD implantation and at 12 months follow-up with the Florida Patient Acceptance Survey (FPAS). Of the 350 patients, 261 patients (75%) completed FPAS at 12 months follow-up. Results The participants’ mean age was 59.7 ± 11.4 years with the majority being male (83%). Total illness perceptions scores were categorised into low experienced threat (n = 182, 52%), medium experienced threat (n = 82, 23%), and high experienced threat (n = 86, 25%). In the multivariate analysis, high experienced threat at ICD implantation was associated with significantly lower device acceptance at 12 months follow-up compared to low (B = -5.80, 95% CI [- 10.61, – -1.00], p = .018) and moderate experienced illness threat (B = -7.35, 95% CI [- 12.32, – -2.38], p = .004) while adjusting for device acceptance at baseline, age, sex, NYHA-class, indication, ischemic heart disease, education, intervention group and device type. In an exploratory analysis investigating associations of all 8 B-IPQ illness perception dimensions (single item-scores) simultaneously regressed on 12-months total FPAS-scores with baseline FPAS-scores as covariate, B-IPQ item 4 measuring treatment control showed the strongest association (B = 0.94, 95% CI [0.13, – 1.76], p = .023) with higher perceived treatment control linked with higher device acceptance. Conclusion ICD patients with high experienced illness threat at ICD implantation had substantially lower device acceptance at one-year post-implantation compared to patients with low-to-moderate experienced illness threat. Perceptions of treatment control at ICD implantation appear to be a potential mediator of this relationship.

Device-specific quality of life: Results from the ATLAS trial-Avoid Transvenous Leads in Appropriate Subjects.

Patient reported outcomes (PROs) provide important insights into patients' acceptance of their medical devices. ATLAS, a randomized, multi-center, open-label clinical trial, recently reported fewer perioperative complications in S-ICD compared to TV-ICD patients. This study reports PROs, including device-specific and generic quality of life (QOL) from the ATLAS trial. Device-specific QOL was the primary PRO using the Florida Patient Acceptance Survey (FPAS) at 1-and 6-months post-implantation. Secondary outcomes included generic QOL using the Medical Outcomes Survey (SF-36) pre-implant and 6-months post-implantation. FPAS and SF-36 were analyzed using ANCOVA. Pain measured using a Numeric Rating Scale, at 1-and 6-months, anesthetic, BMI and within/between differences were analyzed using descriptive statistics and mixed-effects linear models (MLM). Of the 503 patients randomized in ATLAS, 404 had complete FPAS data to include in this analysis. Participant characteristics were balanced. There were no significant differences between S-ICD and TV-ICD for FPAS or SF-36, across timepoints. Mean total FPAS scores increased from 73.73 (16.09) to 77.05 (16.13) and 74.43 (15.35) to 78.25 (15.88) for S-ICD and TV-ICD, respectively, (p <0.001). PROs suggested that both devices were associated with good QOL. Device-specific and generic QOL were similar between S-ICD and TV-ICD groups up to 6-months post-implantation indicating that regardless of device type, both groups reported good device specific QOL in ATLAS patients. S-ICD patients reported higher pain scores at implant, but pain decreased by 6 months. The findings offer evidence that can be included during shared decision-making. The inclusion of patient partners in ATLAS provided opportunity to measure PROs that were deemed important to patients.

Patient-reported quality of life and acceptance of the extravascular implantable cardioverter-defibrillator: Results from pivotal study.

The pivotal study of the extravascular implantable cardioverter-defibrillator (EV ICD) recently demonstrated primary efficacy and safety endpoints comparable to previous ICD systems. Patient experience with this novel device has not been reported. The current study examined the standardized patient-reported outcome (PRO) metrics of quality of life (QOL) and patient acceptance of the device. The EV ICD Pivotal Study was a prospective, single-arm, nonrandomized, global, premarket approval trial. Patients completed the 12-Item Short Form Survey (SF-12) QOL surveys at baseline and at 6 months following implant. Additionally, patients completed the Florida Patient Acceptance Survey (FPAS) QOL survey at 6 months. From baseline to 6 months, patients within the EV ICD Pivotal Study (n = 247) reported statistically significant SF-12 improvements in physical QOL (45.4 ± 9.4 vs. 46.8 ± 9.1 respectively, p = .020) and no changes in mental QOL (49.3 ± 10.4 vs. 50.5 ± 9.7, p = .061). No differences were noted by sex, atrial fibrillation, or the experience of ICD shock. EV ICD patients reported better total FPAS patient acceptance of their ICD than TV-ICD or S-ICD patients using historical norms comparisons (80.4 ± 15.7 vs. 70.2 ± 17.8, p < .0001 for S-ICD and 73.0 ± 17.4, p = .004 for TV-ICD). The initial PROs for EV ICD patients indicated that patients had improvements in physical QOL from baseline to 6-month follow-up and markedly better overall acceptance of their ICD compared to a previous study with S-ICD and TV-ICD data. These initial results suggest that the EV ICD is evaluated positively by patients.

Device specific quality of life in subcutaneous versus transvenous implantable cardioverter defibrillator implantations: results from the ATLAS multi-centre randomized controlled trial

Abstract Background Newer innovative subcutaneous implantable cardioverter defibrillators (S-ICDs) offer an alternative to transverse ICDs (TV-ICDs), placing leads outside of the heart thereby potentially reducing lead-related complications. The ATLAS trial, a multi-centre randomized controlled trial, showed a significant reduction in perioperative complications in TV-ICD versus S-ICD patients. The following results report device-related quality-of-life (QoL) measured in the trial. QoL measures are recognized as key patient-reported outcome measures (PROMs). Purpose To compare TV-ICD and S-ICD post implantation device-related QoL in the ATLAS trial. Methods Sample included all randomized ATLAS trial patients. The Florida Patient Acceptance Survey (FPAS) was completed at 1- and 6-months post implantation. The FPAS includes a total score and 4 subscale scores; 1) return to function, 2) device-related distress, 3) positive appraisal, and 4) body image concerns. Scores are scaled from 0-100, with total scores below 63 suggesting poor device acceptance. The primary analysis was based on complete cases and used analysis of covariance (ANCOVA) with 6-month scores as the dependent variable, group as the independent variable, and 1-month FPAS scores as the covariate. Change in FPAS total score over time within each group was explored using paired t-tests. Results There were 252 TV-ICD and 251 S-ICD patients enrolled in the main ATLAS trial, and of these, in the present analysis, 404 patients (197 TV-ICD; 207 S-ICD) had complete FPAS data. Sample mean age (SD) was 49.31 (11.54) years, males (74.3%) and Caucasian (83.7%). There were no substantive differences in patient characteristics between groups. The primary analyses found no differences between TV-ICD and S-ICD groups for FPAS total score (Mean Difference=-0.75; 95% CI, -3.15, 1.66; p=0.510) or FPAS subscale scores. Mean FPAS total scores increased from 74.43 (15.35) to 78.25 (15.88) and 73.73 (16.09) to 77.05 (16.13) between 1-month and 6-months in the TV-ICD and S-ICD groups respectively. The increase from 1-month to 6-months was statistically significant in both groups (p&amp;lt; 0.001). These findings suggest that regardless of ICD type, there is device acceptance in both groups from implantation and over time. Conclusion Analysis of the FPAS measure, a device-specific QoL measure, found both TV-ICD and S-ICD patients reported good acceptance of their devices, with no significant differences between groups for up to 6 months post implantation. These findings provide an important piece to the TV-ICD versus S-ICD line of inquiry in ICD patient populations particularly for this newer S-ICD innovation and can be included in decision making between health professionals and patients.

Abstract 13716: Implanting an Extravascular ICD in Patients With a Prior Subcutaneous ICD

Background: The Extravascular Implantable Cardioverter Defibrillator (EV ICD) has been demonstrated as an effective therapy to treat sudden cardiac death using a substernal lead position. Limited data regarding the use of EV ICD in patients with prior subcutaneous ICD (S-ICD) is available. Methods: The EV ICD Pivotal study database was reviewed for subjects with a prior S-ICD. Procedure times were compared using the Wilcoxon rank-sum test. Results: Of the 316 subjects that had an implant attempt in the EV ICD Pivotal study, 9 subjects at 3 sites had history of a prior implanted S-ICD. All were male with a mean age of 59.6 ± 14.4 years. Mean Body Mass Index (BMI) was 29.5 ± 4.7. Five subjects had secondary prevention indication. Mean follow up duration was 1.4 ± 0.7 years. The study protocol required S-ICD explant prior to study enrollment. The mean time between S-ICD explant and EV ICD implant was 35 ± 19 days. Procedure times were similar to denovo EV ICD implant. Median times from first incision to final suture, inclusive of defibrillation testing, for subjects with and without prior S-ICD were 79 (IQR, 69 to 108) and 60.5 (IQR, 52 to 84.5) minutes, respectively (P=0.10). All subjects were defibrillated with 30 J or less at implant. There were no major intraprocedural complications and only 1 major complication during the follow up period, an implant site infection at 18 months. The Florida Patient Acceptance Survey, issued at 6 months post-implant, demonstrated high device acceptance rate with little or no body image concerns. Two subjects each had an appropriately treated episode of spontaneous sustained monomorphic VT, one terminated by ATP and the other terminated by shock following ATP. Conclusions: The EV ICD System can be successfully implanted in patients who previously had an S-ICD. History of S-ICD did not significantly increase procedure time. The EV ICD had a high acceptance in this subgroup and may provide advantage over S-ICD due to its smaller size, and ability to deliver ATP.

Efficacy of a web-based healthcare innovation to advance the quality of life and care of patients with an implantable cardioverter defibrillator (ACQUIRE-ICD): a randomized controlled trial.

Modern clinical management of patients with an implantable cardioverter defibrillator (ICD) largely consists of remote device monitoring, although a subset is at risk of mental health issues post-implantation. We compared a 12-month web-based intervention consisting of goal setting, monitoring of patients' mental health-with a psychological intervention if needed-psychoeducational support from a nurse, and an online patient forum, with usual care on participants' device acceptance 12 months after implantation. This national, multi-site, two-arm, non-blinded, randomized, controlled, superiority trial enrolled 478 first-time ICD recipients from all 6 implantation centres in Denmark. The primary endpoint was patient device acceptance measured by the Florida Patient Acceptance Survey (FPAS; general score range = 0-100, with higher scores indicating higher device acceptance) 12 months after implantation. Secondary endpoints included symptoms of depression and anxiety. The primary endpoint of device acceptance was not different between groups at 12 months [B = -2.67, 95% confidence interval (CI) (-5.62, 0.29), P = 0.08]. Furthermore, the secondary endpoint analyses showed no significant treatment effect on either depressive [B = -0.49, 95% CI (-1.19; 0.21), P = 0.17] or anxiety symptoms [B = -0.39, 95% CI (-0.96; 0.18), P = 0.18]. The web-based intervention as supplement to usual care did not improve patient device acceptance nor symptoms of anxiety and depression compared with usual care. This specific web-based intervention thus cannot be recommended as a standardized intervention in ICD patients.

Body image concerns in patients with an implantable cardioverter defibrillator: associations with other patient-reported outcomes

Abstract Funding Acknowledgements Type of funding sources: None. Background/Introduction Implantation with an implantable cardioverter defibrillator (ICD) is for some patients associated with body image concerns (BICs). The associations of BICs with other patient-reported outcomes (PROs) have not yet been investigated. Purpose The purpose of this study was to investigate the associations between BICs and other PROs in a cohort of ICD-recipients. Methods A cross-sectional survey design was used. Patients who had the ICD in minimum 3 months up to 2 years, age &amp;gt;18 years, implanted with a first-time ICD (both VVI-ICD, DDD-ICD and CRT-D) completed the 39-item ICD Body Image Concerns Questionnaire (ICD-BICQ) together with the Generalized Anxiety Disorder scale (GAD-7), Patient Health Questionnaire (PHQ-9), Type D Scale (DS14) and the Florida Patient Acceptance Survey (FPAS). Data were analyzed using linear regression to compare personality constructs between patients with and without BICs. Logistic repression and Reciever Operating Characteristic (ROC) curves were used to predict patients with BICs based on other PROs. Results In total 331 patients completed the ICD-BICQ and other PRO questionnaires. Five patients were excluded due to re-operations, and one patient did not complete the ICD-BICQ, leaving 325 patients in the analyses. As anticipated 20% of patients reported body image concerns with a cut-off at the recommended 36 points. We found that patients with BICs reported higher anxiety and depression levels, lower device acceptance using the FPAS, and lower health status, while they were more likely to have a Type D personality as compared to patients without BICs. We observed that FPAS was moderately able to predict BICs, while other PROs only had limited ability to predict BICs in patients, hence indicating that the ICD-BICQ provides relevant clinical information. Conclusion(s) In this study, we found that patients with BICs generally reported worse PRO scores. The included PRO instruments were not able to predict BICs the ICD recipients, hence in clinical practice, health care professionals can use the ICD-BICQ to identify and obtain a nuanced picture of patients with BICs. In case of implementing new operation techniques, the ICD-BICQ can be used as a tool for evaluation.

Validity and reliability of the Brazilian Portuguese version of the Florida Patient Acceptance Survey for patients with implantable cardioverter defibrillators

Device acceptance is a crucial factor in identifying implantable cardioverter defibrillator (ICD) patients at risk for psychosocial distress and unfavorable quality of life outcomes. The purpose of this study was to examine the evidence of the validity of internal structure (construct) and reliability of the Florida Patient Acceptance Survey (FPAS) in a sample of ICD patients, comparing the psychometric indicators of the complete (FPAS-18 item) and abbreviated (FPAS-12 item) versions. The sample included 151 participants (97 males, mean age of 55.7 ± 14.1 years) who completed the cross-culturally adapted version of the FPAS instrument for the Brazilian context. The psychometric properties of both versions of the FPAS instrument were evaluated by two distinct approaches:•Exploratory and confirmatory factor analysis: used to test the internal structure of the instrument•Cronbach's Alpha and McDonald's Omega: used to determine the reliability of the instrumentThe two versions of the FPAS-Br instrument showed consistent evidence of internal structure validity and reliability. However, the FPAS-Br 12-item showed a better psychometric adjustment, confirmed by the analysis of the quality indicators of the models.

Submammary Implantation of Internal Pulse Generators for Deep Brain Stimulation: Long-Term Follow-up of Device Acceptance and Quality of Life in Women

A submammary approach to implanting pulse generators is innovative and has yielded good aesthetic results in the current literature. It was our aim to make a comparison of patient device acceptance, tolerance, and complications between submammary and abdominal device locations in deep brain stimulation. Twenty-five and 28 patients were included in the submammary and abdominal groups, respectively. Our primary criterion was patient acceptance that was calculated using total Florida Patient Acceptance Survey (FPAS) scores in each group. Secondarily, tolerance was assessed in the submammary group by means of a specific questionnaire. Total FPAS scores from the submammary group [total FPAS: 77.1 versus 74.7, P=0.29] revealed no significant difference when compared with the abdominal group. The same similarities were observed regarding the 4 subscales: return to function [16.3 versus 15.8, P=0.53], device-related distress [22.0 versus 21.3, P=0.31], body image concerns [9.2 versus 8.6, P=0.14], and positive appraisal [17.8 versus 17.4, P=0.58]. Tolerance was reported as good by the majority of the women from the submammary group. There was no evidence of higher infection rates in the submammary implantation (SMI) group. SMI is a satisfactory alternative to other deep brain stimulation locations. SMI is a feasible option for any young woman who is eligible for deep brain stimulation.

Patient acceptance of subcutaneous versus transvenous defibrillator systems: A multi-center experience.

The subcutaneous implantable cardioverter-defibrillator (S-ICD) is an effective alternative to the transvenous ICD. No study has yet compared S-ICD and transvenous ICD by assessing patient acceptance as a patient-centered outcome. To evaluate the patient acceptance of the S-ICD and to investigate its association with clinical and implantation variables. In patients with symptomatic heart failure and reduced ejection fraction (HFrEF), the acceptance of the S-ICD was compared with a control group of patients who received a transvenous ICD. Patient acceptance was calculated with the Florida Patient Acceptance Survey (FPAS) which measures four factors: return to function (RTF), device-related distress (DRD), positive appraisal (PA), and body image concerns (BIC). The survey was administered 12 months after implantation. 176 patients underwent S-ICD implantation. The total FPAS and the single factors did not differ according to gender, body habitus, or generator positioning. Patients with HFrEF had lower FPAS and RTF. Younger patients showed better RTF (75 [56-94] vs. 56 [50-81], p = .029). Patients who experienced device complications or device therapies showed higher DRD (40 [35-60] vs. 25 [10-50], p = .019). Patients with HFrEF receiving the S-ICD had comparable FPAS, RTF, DRD, and BIC to HFrEF patients implanted with the transvenous ICD while exhibited significantly better PA (88 [75-100] vs. 81 [63-94], p = .02). Our analysis revealed positive patient acceptance of the S-ICD, even in groups at risk of more distress such as women or patients with thinner body habitus, and regardless of the generator positioning. Among patients receiving ICDs for HFrEF, S-ICD was associated with better PA versus transvenous ICD.

Psychometric evaluation of the implantable cardioverter defibrillator body image concerns questionnaire (ICD-BICQ).

Patients receiving an implantable cardioverter defibrillator (ICD) generally adapt well to living with their device, but we know little about the prevalence of patients' body image concerns (BICs) postimplant. The objectives were to evaluate the psychometric properties of the ICD-body image concerns questionnaire (BICQ), find a cut-off indicating BICs and determine the prevalence of BICs. Construct validity was determined using the Kaiser-Meyer-Olkin test, Scree-plot and explorative factor analysis. Internal consistency was examined via Cronbach's alpha. Correlations to other validated questionnaires, a weighted and simple scale and a cut-off indicating BICs was evaluated. In total, 331 patients completed the 39-item ICD-BICQ together with: Type D Scale (DS14), Generalized Anxiety Disorder scale (GAD-7), Patient Health Questionnaire (PHQ-9), and Florida Patient Acceptance Survey. Five patients were excluded due to reoperations, leaving 326 patients in the analyses. Results revealed a one-factor structure with 32 items and Cronbach's alpha at.948. A cut-off at 36 points displayed the 20% patients with the highest score of BICs. The prevalence was 29.8% in women and 18.4% in men. The psychometric evaluation of the 32-item ICD-BICQ showed acceptable construct validity and internal reliability. We recommend a cut-off score at 36 points to identify patients at risk of having BICs. The prevalence of BICs indicated that both men and women are at risk of having BICs. The ICD-BICQ can be used in clinical practice to help healthcare professionals to identify patients at risk of BICs and as to evaluate BICs when implementing new operation techniques.

Anxiety and depression in inherited channelopathy patients with implantable cardioverter-defibrillators.

BackgroundImplantable cardioverter-defibrillators (ICDs) are an effective treatment in some patients with inherited heart disease, including inherited channelopathies, yet they have also been shown to impact patients’ psychological health.ObjectiveWe sought to improve understanding of the level of anxiety and depression as well as device acceptance among inherited channelopathy patients with an ICD.MethodsEligible patients seen at Johns Hopkins Hospital were sent a survey, which included the Hospital Anxiety and Depression Scale (HADS), Cardiac Anxiety Questionnaire (CAQ), and the Florida Patient Acceptance Survey (FPAS). Student t tests and χ2 tests were used to identify associations with abnormal anxiety and depression scores.ResultsAmong eligible patients (n = 65), 32 individuals (49%) completed the survey. The rate of device-related complications was 34%, and 41% of patients experienced 1 or more ICD shocks. Twelve patients (38%) had an abnormal HADS anxiety subscore and 5 patients (16%) had an abnormal HADS depression subscore (score ≥ 8). Secondary-prevention ICDs were associated with an abnormal HADS anxiety subscore (P = .03). Experiencing ICD shock(s), device complications, age, sex, and family history of sudden cardiac death were not statistically associated with anxiety or depression. Overall, respondents demonstrated high device acceptance by FPAS (79.9 ± 2.9, maximum total score 100) and moderately high cardiac-specific anxiety by CAQ total score (1.53 ± 0.12).ConclusionA high prevalence of generalized anxiety was identified among inherited channelopathy patients with ICDs. High device acceptance and lack of association with ICD shocks or complications indicate that further research is necessary to understand this increased incidence.

Leadless pacemaker versus transvenous single-chamber pacemaker therapy: peri-procedural aspects, utilization of medical resources and patient acceptance

ABSTRACT Background Leadless pacemaker (L-PM) have been developed in order to overcome the lead- and pocket-related complications associated with transvenous pacemaker (T-PM). The impact of L-PM implantation on the utilization of medical resources, patient comfort and therapy acceptance could differ from that of T-PM. Research design and methods Prospective, single-center study enrolling 243 consecutive patients undergoing PM implantation. Propensity matching for baseline characteristics yielded 77 matched pairs. Procedural data, patient acceptance (assessed by Florida Patient Acceptance Survey, FPAS) and quality of life (QoL) (assessed at the baseline, 1 week, 3 and 6 months) were compared between the two groups (L-PM and T-PM). Results The implantation procedure was longer in L-PM than T-PM patients (42.2±16.3 vs. 28.9±11.9 minutes; p<0.001). L-PM was associated with lower intra- and post-operative pain intensity (all p<0.05), shorter hospitalization (3.2±0.5 vs. 3.5±1.1 days; p=0.034), greater patient acceptance (FPAS score: 58.7±7.1 vs. 40.5±4.1; p<0.001), and better QoL on both physical and mental health scales (all p<0.05). Conclusions Although L-PM implantation takes longer than T-PM, it is better tolerated and accepted by patients and is associated with a better QoL.

Validity and Reliability of the Japanese Version of the Florida Patient Acceptance Survey.

Patient acceptance of implantable cardioverter defibrillators (ICDs) is one of the factors influencing clinical outcomes. This study aimed to develop a Japanese version of the Florida Patient Acceptance Survey (FPAS; a measure of acceptance of ICDs), examine its reliability and validity, and test instrument reliability and ability to generate valid data in a new population. 122 outpatients with ICD, cardiac resynchronization therapy defibrillator (CRTD) completed the FPAS, the 12-Item Short-Form Health Survey developed for the Medical Outcomes Study, and the Hospital Anxiety and Depression Scale. Confirmatory and exploratory factor data analyses yielded a three-factor model with nine items. This version of the FPAS had high internal consistency, both for the single factor scale and all other subscales; Cronbach's 𝛼 ranged from .78 to. 84. The scale was shown to be valid and reliable for assessing device acceptability in Japanese patients with ICD.

Testing a nurse-led, pre-implantation educational intervention for primary prevention implantable cardioverter-defibrillator candidates: a randomized feasibility trial

Implantable cardioverter-defibrillators (ICDs) deliver therapy for life-threatening arrhythmias. Evidence suggests that ICD candidates have misconceptions regarding ICD therapy and unmet information needs. We undertook a pilot feasibility trial comparing a nurse-led educational intervention plus standard care, vs. standard pre-ICD implantation care. Secondary aims included examination of anxiety, quality of life, and shock anxiety. Implantable cardioverter-defibrillator candidates were consented and randomized to standard pre-ICD implantation care vs. standard care plus a nurse-led educational intervention. The primary feasibility outcomes included: recruitment rate, consent rate, randomization rate, proportion of participants able to complete all questionnaires, time to deliver intervention, and intervention topics completion. At baseline, demographic and Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety scores were collected. Four weeks post-ICD implantation, participants completed the PROMIS, Florida Patient Acceptance Survey (FPAS), and Florida Shock Anxiety Scale (FSAS). Twenty patients consented (10 per group). Feasibility targets were achieved for all but two outcomes: consent rate was 87% vs. 95% target, and completion of data collection measures was 85% vs. 90% target. Consent rate was lower than expected as one patient declined, and two could not be approached. Completion rate was lower than expected as two patients were lost to follow-up, and one did not receive an ICD during the study period, leading to incomplete post-implantation survey collections. The results demonstrate the feasibility of conducting a trial comparing a nurse-led pre-implantation educational intervention to standard care in an outpatient setting. Further study to evaluate the effectiveness of this intervention on patient-reported outcomes is warranted.

Patient reported outcomes and quality of life in Chinese patients with implantable cardioverter defibrillators✰

ObjectivesPatient reported outcomes in Implantable Cardioverter Defibrillator (ICD) patients can describe the experience of living with heart disease and with an ICD. However, very little is known about patient outcomes among Chinese patients which may limit effective patient discussions and interventions for these patients. The purposes of this study were to examine device related experiences (e.g., device acceptance, shock anxiety) in Chinese ICD patients and identify potential variables that influence health related quality of life (HRQOL) and to compare HRQOL outcomes to healthy and heart failure populations. MethodsThis study used a cross-sectional research design with serially recruited ICD patients (N = 100) from clinics in China. Participants completed surveys including: the 12-Item Short-Form Health Survey Questionnaire (SF-12), Florida Patient Acceptance Survey (FPAS), Florida Shock Anxiety Scale (FSAS), Type D Scale (DS-14), and general information questionnaire. ResultsParticipants were 100 ICD patients in China with a mean age of 53.32(SD = 13.70). The mean scores of the SF-12 physical component summary (PCS) and mental component summary (MCS)of ICD patients (43.55 and 47.07, respectively) were lower than the Chinese general population (P<0.001) and general health, social functioning, and role emotional scores were lower than chronic heart failure patients (P<0.001). Multiple linear regression analysis indicated that LVEF, positive shock history, age and shock anxiety were significant predictors of physical function and accounted for 24.5% of the adjusted variance. Type D personality, shock history, and shock anxiety were predictors of the mental health component and accounted for 25.9% of the variance. Shock history, age, type D personality, and shock anxiety significantly predicted device acceptance (FPAS-Total) and accounted for 32% of variance. ConclusionsICD patients reported health outcomes were generally lower than the Chinese general population and patients with heart failure in relation to general health, social functioning, and role emotional. Both generic and disease specific HRQOL were influenced by both medical and psychosocial predictors. This suggests that current Western society based comprehensive models of patient HRQOL and patient care needs may extend to Chinese patients with ICDs.

Age, Sex, and Remote Monitoring Differences in Device Acceptance for Patients With Implanted Cardioverter Defibrillators in Canada

BackgroundImplantable cardioverter defibrillator (ICD) acceptance and shock anxiety are issues that clinicians should address to improve quality of life among device recipients. Previous findings have indicated that younger patients experience poorer device adjustment. The purpose of this study was to examine age and ICD-specific quality-of-life outcomes in a large sample of Canadian ICD patients. We tested the hypothesis that patient age is related to device acceptance and shock anxiety in an Alberta (Canada) ICD population. MethodsThe Florida Patient Acceptance Survey (FPAS) and Florida Shock Acceptance Survey (FSAS) were completed by ICD patients attending the Cardiac Implantable Electrical Device Clinics in Alberta. The population was dichotomized into those aged ≤ 65 years (younger) and those aged > 65 years (older). Sex, ICD shock history, and remote monitoring use were also examined. ResultsSurveys were completed by 126 younger (53 ± 11 years; 79% male) and 216 older (74 ± 6 years; 85% male) patients. Younger, compared with older, patients had greater device-related distress (P < 0.001) and more body-image concerns (P < 0.001), but no differences in return to function or positive appraisal. Younger patients reported lower total device acceptance (P = 0.001) and greater total shock anxiety (P < 0.001) compared with older patients. ConclusionsICD patients aged ≤ 65 years reported poorer device acceptance and greater shock anxiety than older patients. Younger patients may require targeted interventions addressing adjustment to the ICD, and impact of the ICD on body image. Moreover, education about the relatively low probability of shocks may alleviate shock anxiety in younger patients.

The INFluence of Remote monitoring on Anxiety/depRession, quality of lifE, and Device acceptance in ICD patients: a prospective, randomized, controlled, single-center trial

BackgroundImpact of telemedicine with remote patient monitoring (RPM) in implantable cardioverter–defibrillator (ICD) patients on clinical outcomes has been investigated in various clinical settings with divergent results. However, role of RPM on patient-reported-outcomes (PRO) is unclear. The INFRARED-ICD trial aimed to investigate the effect of RPM in addition to standard-of-care on PRO in a mixed ICD patient cohort.Methods and resultsPatients were randomized to RPM (n = 92) or standard in-office-FU (n = 88) serving as control group (CTL). At baseline and on a monthly basis over 1 year, study participants completed the EQ-5D questionnaire for the primary outcome Quality of Life (QoL), the Hospital Anxiety and Depression Scale, and the Florida Patient Acceptance Survey questionnaire for secondary outcomes. Demographic characteristics (82% men, mean age 62.3 years) and PRO at baseline were not different between RPM and CTL. Primary outcome analysis showed that additional RPM was not superior to CTL with respect to QoL over 12 months [+ 1.2 vs. + 3.9 points in CTL and RPM group, respectively (p = 0.24)]. Pre-specified analyses could not identify subgroups with improved QoL by the use of RPM. Neither levels of anxiety (− 0.4 vs. − 0.3, p = 0.88), depression (+ 0.3 vs. ± 0.0, p = 0.38), nor device acceptance (+ 1.1 vs. + 1.6, p = 0.20) were influenced by additional use of RPM.ConclusionThe results of the present study show that PRO were not improved by RPM in addition to standard-of-care FU. Careful evaluation and planning of future trials in selected ICD patients are warranted before implementing RPM in routine practice.Graphic abstract

Long-term cardiac arrhythmia and chronotropic evaluation in patients with severe anorexia nervosa (LACE-AN): A pilot study.

Anorexia nervosa (AN) is associated with autonomic dysfunction and carries a high risk of sudden death, putatively attributed to ventricular tachyarrhythmias. To date, long-term cardiac monitoring has not been performed to confirm this speculation. We assessed the safety and acceptability of an insertable cardiac monitor (ICM) in patients with severe AN with markedly reduced body mass index (BMI), and investigated heart rate (HR) and rhythm before and after weight restoration. Autonomic function was assessed as HR response to a standardized activity protocol at baseline and four additional visits over 360 days. The Florida Patient Acceptance Survey (FPAS) was used to measure ICM acceptability. During a mean follow-up of 10 months, no ICM-related complications occurred and ICM was well-accepted by the 11 study participants (nine women, aged 19-59 years, baseline BMI = 12.7 ± 1.6 kg/m2 ). Both resting and peak HR increased with weight restoration and were directly associated with BMI (both P < .001). No ventricular tachyarrhythmias occurred during the study period, but two participants (18%) experienced eight sinus pauses (3.0-7.0 seconds) and three runs of supraventricular tachycardia. Long-term cardiac rhythm monitoring with an ICM is feasible, safe, and acceptable in patients with severe AN. Autonomic dysfunction in AN results in not only profound resting bradycardia, but also some degree of chronotropic incompetence, both of which improve with weight restoration. Clinically significant bradyarrhythmias are more common than ventricular tachyarrhythmias in AN, and may represent a competing underlying mechanism for the high risk of sudden death in this population.

Relationship between device acceptance and patient-reported outcomes in Left Ventricular Assist Device (LVAD) recipients

The number of Left Ventricular Assist Devices (LVADs) implanted each year is rising. Nevertheless, there are minimal data on device acceptance after LVAD implant, and on its relationship with patient-reported outcomes. We designed a cross-sectional study to address this knowledge gap and test the hypothesis that low device acceptance is associated with poorer quality of life, depression and anxiety. Self-report questionnaires were administered to assess quality of life (12-item Kansas City Cardiomyopathy Questionnaire quality of life subscale), level of anxiety (7-item Generalized Anxiety Disorder; GAD-7), level of depression (9-item Patient Health Questionnaire; PHQ-9) and device acceptance (Florida Patient Acceptance Survey; FPAS) to 101 consecutive patients presenting to LVAD clinic. Regression analysis showed a strong correlation between device acceptance and both psychological distress (p < 0.001) and quality of life (p < 0.001). Analysis of the sub-scales of the FPAS showed that patients had significant body image concerns, but return to function and device-related distress were the main drivers of the observed correlation between device acceptance and patient well-being. Younger age was associated with lower device acceptance (r = 0.36, p < 0.001) and lower quality of life (r = 0.54, p < 0.001). These findings suggest that interventions targeting device acceptance should be explored to improve outcomes in LVAD recipients.