bluuebunny/crossref_metadata_2025 huggingface dataset:
High success and safety of transvenous lead extraction using excimer laser sheaths in more than 1700 patients: a meta-analysis
Authors: Rinaldi C A , Biffi M , Diemberger I , Defaye P , Sizto E , Gao Y R , Epstein L M , Carrillo R
Published: May 2023

Funding Acknowledgements

Type of funding sources: Private company. Main funding source(s): Philips

Background

The excimer laser sheath is a commonly used advanced transvenous lead extraction (TLE) tool to aid the successful extraction of indwelling cardiac leads by ablating the tissues adhering to the leads. Many studies have reported favorable safety and efficacy results with leaser sheath assisted TLE in small patient groups. However, to date, there are no comprehensive large-scale studies using contemporary data to analyze the outcomes of excimer laser sheaths assisted TLE.

Purpose

To assess the performance and safety of excimer laser sheath assisted TLE using meta-analysis of contemporary data.

Methods

A systematic literature search was performed to identify articles relevant for the evaluation of the safety and performance of the SLS II and GlideLight excimer laser sheaths in TLE procedures from April 1, 2016 to March 31, 2021. Safety outcomes included procedure-related deaths and major and minor complications. Performance outcomes included procedural success and clinical success rates achieved in TLE procedures as defined by 2017 HRS and 2018 EHRA consensus guidelines. A random-effects, inverse-variance-weighting meta-analysis using arsine square root transformation was performed to obtain the weighted average of evaluated outcomes.

Results

A total of 17 articles were identified and included for evaluation and data extraction, among which 6 were prospective studies and 11 were retrospective studies. The evaluated studies included 1,729 patients with 2,887 leads, among which 311 leads were extracted with the SLS II device, 1,688 were extracted using GlideLight, and the rest (n=888) involved both devices. Overall, 38.5% of leads were extracted due to infection. The most common lead type targeted for extraction were ICDs (47.9%). On average, each patient had 2.3 ± 0.3 leads and the lead dwell time was 7.9 ± 3.0 years. The TLE procedure successes rate per patient was 96.8% (1,440/1,505; 95% CI: [94.9%-98.2%]) and per lead 96.6% (1,447/1,501; 95% CI: [95.1%-97.7%]). The clinical success rate per patient was 98.3% (989/1,010, 95% CI: [97.4%-99.0%]). The weighted average of the procedure-related death rate was 0.08% (7/1,729, 95% CI: [0.00%, 0.34%]), comparable to the mortality rate reported in other studies on lead extraction safety. The most common complications were pericardial effusion or tamponade (n=21), hematoma (n=20) and cardiovascular injuries (n=18).

Conclusion

TLE utilizing the excimer laser sheath has high success and low mortality rates and provides physicians with a valuable tool for safe and effective extraction of indwelling cardiac leads that require advanced extraction techniques.
Gradually increasing impedance in patients with pacemakers and implantable defibrillators: a watchful waiting strategy
Authors: Maass A , Klingenberg M , Groenveld H F , Mulder B A , Blaauw Y , Rienstra M
Published: May 2023

Funding Acknowledgements

Type of funding sources: Public hospital(s). Main funding source(s): hospital resources

Introduction

Pacing impedance measurements are important in the surveillance of pacemaker and implantable cardioverter/defibrillator (ICD) devices. Whereas sudden changes in impedances can reflect lead fracture or isolation defects, gradually increasing impedances are thought to occur because of calcifications at the endomyocardial interface. In many cases, these leads are replaced prophylactically but this has not been studied systematically.

Purpose

We aimed to identify the outcome of right ventricular (RV) electrodes with high impedances that were left active in this single center study.

Methods

All patients in the electronic patient database were screened for impedances >1200Ohms. 41,201 individual recordings led to 219 individual patients. 161 patients were excluded from the analysis due to sudden impedance increase, temporarily high impedances or wrong entry. Of the remaining 58 patients, baseline characteristics as well as pacing impedance, sensing values, pacing thresholds, and shock impedance in case of ICDs were recorded.

Results

There were 17 pacemaker and 41 ICD patients, 68±15 years old, 69% were male. Glomerular filtration rate at baseline was 81±22 ml/min/1.73m2. Baseline RV impedance was 597±123Ohms. During follow-up impedances increased to 1875±682Ohms (p<0,001). Pacing thresholds increased from 0,6±0,4V to 3,0±1,9V (p<0,001). Sensing remained stable. The median time from implant to impedance rise >1000Ohms was 5,5 (3,4-7)years and median follow-up thereafter 3,8 years (1,6-6,6). During follow-up, no intervention was performed for 45 leads (78%). No events occurred. 13 leads (22%) were replaced , 9 prophylactically (mostly because of ICD advisory leads), 3 because of high pacing thresholds and high percentage pacing and one lead because of noise oversensing, probably unrelated as it occurred 7 years after impedance increase.

Conclusions

A watchful waiting strategy appears to be a safe option for patients with ICDs and pacemakers with low percentage pacing. As impedance increase cannot be used for surveillance for imminent lead fracture, other means such as short interval counts and non-sustained oversensing have to be employed and should be combined with remote monitoring.
Transvenous vs. subcutaneous ICDs after transvenous device complication
Authors: Willy K , Frommeyer G , Wolfes J , Ellermann C , Wegner F K , Rath B , Koebe J , Reinke F , Eckardt L
Published: May 2023

Funding Acknowledgements

Type of funding sources: Private company. Main funding source(s): Boston Scientific

Background

During long-term follow-up of patients with implantable cardioverter defibrillators (ICD) numerous problems may occur. Apart from lead failure cardiac device related infectious endocarditis poses a serious threat to the patient. To date, there is no data on the question whether a re-implantation of a transvenous ICD (tv-ICD) or the implantation of a subcutaneous ICD (S-ICD) might be the better choice.

Methods and Results

The present study represents a single-center experience of matched patients with a complication of tv-ICDs which had to be revised. The patient either received a tv- or an S-ICD thereafter. 103 patients (53 patients in each group) were included, follow-up duration was about 3 years in both groups. Patients from the tv-ICD group were slightly older (58 vs 52 years). Infections as well as oversensing were equally responsible for revision in both groups (infection: tv 49%, S-ICD 45%, oversensing: tv 51%, S-ICD 45%). During follow-up unscheduled re-hospitalization (tv 60 %, S-ICD: 38%), re-infection (tv 9.4% vs. S-ICD 1.9%) and re-revision (tv: 18.9% vs S-ICD 5.7%) were all significantly more often in the tv-ICD group.

Conclusion

ICD patients who experienced a prior complication of a tv-ICD are at a considerable risk for a repeated complication if a new tv-ICD is implanted. Complication rates of S-ICDs in these patients seem to be lower so that S-ICD implantation might be preferred. Larger trials and prospective data is mandatory.
Regional patterns of activation during induced ventricular fibrillation in Brugada Syndrome
Authors: Sanchez Munoz J J
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Introduction

The activation pattern of induced ventricular fibrillation (VF) in Brugada Syndrome (BS) is not well known.

Objectives

The aim is to establish a hypothesis about temporal activation in the right ventricle (RV) during induced VF in BS patients.

Methods

We examined the sequence of electrical activation in RV during induced VF by programmed stimulation (PS) in 8 patients diagnosed with BS. The 12 ECG leads were analyzed and the electrograms (EGMs) were recorded from a quadripolar catheter placed in the RV apex or in the right ventricular outflow tract (RVOT), from which ventricular fibrillation was induced.

Results

ECG recordings and EGMs of VF were analyzed in 8 patients diagnosed with BS. VF was induced from the RV apex and the RVOT in 6 and 2 patients respectively. From the onset of induced VF to the appearance of sinusoidal waves, three activation areas were observed based on ECG morphology and the activation timing of the right ventricular EGM: apex, moderator band (MB), and RVOT. The first activated area coincided from where VF was induced. The second activated area was the MB in 6 patients. Following RV apex activation, a sinusoidal signal appeared in 2 patients with no activation area being distinguished. Activation was from the MB to RVOT and toward the RV apex in 3 and 2 patients respectively.

Conclusion

In ventricular fibrillation induced in Brugada Syndrome, the activation pattern is sequential from RVOT to RV apex and vice versa through the moderator band.
Measured and genetic LDL-C and the risk of incident atrial fibrillation
Authors: Park H , Kim D H , Jang E , Yu H T , Kim T H , Sung J H , Pak H N , Lee M H , Yang P S , Joung B Y
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Background

Preventive therapy for atrial fibrillation (AF) is lacking, and association between hyperlipidemia and incident atrial fibrillation has been reported. We examined whether measured and genetically predicted low density lipoprotein cholesterol (LDL-C) can detect incident atrial fibrillation (AF) independent of clinical risk for AF.

Methods

A total of 339,023 individuals aged 39 to 73 without pre-existing ASCVD (coronary artery disease, ischemic stroke or transient ischemic attack, peripheral artery occlusive disease) and AF were included from the UK biobank. Clinical risk for AF was based on tertiles of CHARGE-AF (Cohorts for Heart and Aging Research in Genomic Epidemiology- Atrial Fibrillation) score. We calculated the risk of incident AF per SD increase in measured and genetic LDL, and its association with CHARGE-AF.

Results

Over a median 11.9 (11.2-12.6) years, the primary outcome occurred in 17,504 patients. Among those with low, moderate, and high CHARGE-AF, each SD increase in measured LDL-C was associated with hazard ratio of 1.09 (95% CI 0.85-1.38, p=0.502), 1.32 (95% CI 1.13-1.54, p<0.001), and 1.23 (95% CI 1.12-1.37, p<0.001). Among these same categories, each SD increase in genetic LDL-C was associated with hazard ratios of 1.10 (95% CI 1.04-1.16, p<0.001), 1.07 (95% CI 1.03-1.11, p<0.001), and 1.05 (95% CI 1.03-1.07, p<0.001). Among those with normal LDL, untreated hyperlipidemia, and treated hyperlipidemia, each SD increase in genetic LDL-C was associated with hazard ratios of 1.11 (95% CI 1.04-1.18, p=0.001), 1.07 (95% CI 1.05-1.09, p<0.001), and 1.02 (0.99-1.05, p=0.25).

Conclusion

LDL cholesterol polygenic risk score may augment identification of individuals at heightened AF risk, including those with low CHARGE-AF or normal LDL-C. Whether it may also guide antilipidemic initiation or intensification requires further study.
Is elevated calcium score alone or with the additional contribution of excess epicardial fat the trigger causing early inflammation leading to ECG abnormalities?
Authors: Sabatini A , El Shahawy M
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Background

Elevated EFV has been recently reported to be prevalent and a possible contributor to higher cardiovascular morbidity and mortality, particularly in the presence of elevated CACS.

Purpose

To assess whether elevated EFV in the presence of CACS has significant effects on the cardiac electrical activity as evidenced by 12-lead ECG abnormalities, in addition to triggering inflammation in the microvasculature (C2), altering the lipid profile and altering BP rise PME, in comparison to population without elevated EFV and the same demographic.

Methods

2932 asymptomatic subjects, 50 years +, underwent cardiovascular disease (CVD) risk assessment using the Early Cardiovascular Disease Risk Scoring System (ECVDRS), known as Rasmuessen Risk Score (RRS), which has been previously reported. The ECVDRS includes 10 cardiovascular tests, 7 of these tests are vascular and 3 are cardiac. 334 subjects underwent a cardiac CT for EFV and CACS determination. Out of these, 55 participants (43M + 12F) with significantly elevated CACS and elevated or normal EFV were further assessed regarding their exercise level, structural/functional abnormalities, presence of significant OCAD or INOCAD as assessed by cardiac catheterization, exercise stress test, and nuclear stress test.

Results

As shown in Table:

Conclusion

Increased CACS in the presence of normal EFV is not associated with significant inflammatory factors, obstructive CAD, and functional abnormalities.

We postulate that increased CACS in the presence of normal EFV may be associated with perivascular rather than intravascular calcium deposition.

Subjects with normal EFV have less structural and functional abnormalities even in the presence of elevated CACS in comparison to subjects with elevated EFV.

Subjects with elevated EFV are associated with significant prevalence of ECG abnormalities.

Based on our data, we recommend lifestyle modification with an emphasis on high levels of exercise along with novel treatment reported recently to decrease EFV aiming to reduce the risk of arrhythmia.
Assessment of the atrial fibrillation burden in Holter ECG recordings using artificial intelligence
Authors: Hennings E , Coslovsky M , Paladini R E , Aeschbacher S , Knecht S , Schlageter V , Krisai P , Badertscher P , Sticherling C , Osswald S , Kuehne M , Zuern C S
Published: May 2023

Funding Acknowledgements

Type of funding sources: Foundation. Main funding source(s): Swiss National Science Foundation, Swiss Heart Foundation

Background

Emerging evidence indicates that a high atrial fibrillation (AF) burden is associated with adverse outcome. However, AF burden is not routinely measured in clinical practice. An artificial intelligence (AI)-based tool could facilitate the assessment of AF burden.

Purpose

We aimed to compare the assessment of AF burden performed manually by physicians with that measured by an AI-based tool.

Methods

We analysed 7-day Holter ECG recordings of AF patients included in a prospective multicentre cohort study. AF burden was defined as percentage of time in AF, and was assessed manually by physicians and by an AI-based tool. We evaluated the agreement between both techniques by means of Pearson`s correlation coefficient, linear regression model, and Bland-Altman plot.

Results

We assessed the AF burden in 100 Holter ECG recordings of 82 patients. We identified 53 Holter ECGs with 0% or 100% AF burden, where we found a 100% correlation. For the remaining 47 Holter ECGs with an AF burden between 0.01% and 81,53%, Pearson’s correlation coefficient was 0.998. The calibration intercept was -0.001 (95% CI -0.008; 0.006), and the calibration slope was 0.975 (95% CI 0.954; 0.995; multiple R2 0.995, residual standard error 0.017). Bland-Altman analysis resulted in a bias of -0.006 (95% limits of agreement -0.042 to 0.030).

Conclusion

The assessment of AF burden with an AI-based tool provides very similar results compared to manual assessment. An AI-based tool may therefore be an accurate and efficient option for the assessment of AF burden.
Opportunistic screening for atrial fibrillation using a photoplethysmography technique in geriatric patients, a preliminary analysis of the Dutch-GERAF Study
Authors: Zwart L A R , Jansen R W M M , Spruit J R , Pisters R , Riezebos R K , De Groot J R , Hemels M E W
Published: May 2023

Funding Acknowledgements

Type of funding sources: Private company. Main funding source(s): Happitech. Provided the mobile photoplethysmography application

Background

Undiagnosed atrial fibrillation (AF) poses a great risk for stroke in high-risk patients. Different screening strategies have been developed to identify these patients. Geriatric patients often have multimorbidity, and are to be considered a population at very high risk for development of AF and cardiovascular events, but may have less access to wearable screening devices.

Purpose

The Dutch multicentre study into opportunistically screening of Geriatric patients for Atrial Fibrillation using a PPG smartphone App (the Dutch-GERAF Study) applies opportunistic screening to ambulatory geriatric patients, to identify new cases of AF and optimize stroke prevention. This preliminary analysis describes the feasibility and willingness to use of a smart phone photoplethysmography (PPG) application in an ambulatory cohort.

Method

Analysis of participation data and PPG use, of all included patients aged 70 years or older within the GERAF study. The GERAF study is a multicentre study on opportunistic screening for AF using a PPG application among patients visiting a geriatric outpatient clinic. All patients without a pacemaker/ICD, severe tremor, or severe dementia were invited to participate, during a 6 months screening period. Patients were stimulated to use the application at home on their own mobile device at least 3 times within 6 months following inclusion. If preferred by the patient, the application was installed on the mobile device of a spouse or other family member. The PPG signals were analysed using the commercially available algorithm.

Results

Data on PPG use for patients was available for 568 patients. Of these, 122 (21.5%) had a history of AF, and therefore not included in this analysis. Data on PPG use was analysed of 446 patients, 240 were female (54%), average age was 79 ± 5.5 years, the oldest patient was 95 years old. In total, patients performed 2232 PPG recordings within 6 months, in which a sufficient signal was acquired in 1874 (84%) recordings. The signal appeared sufficient at the first attempt in 79.3% of the recordings. In case of a failed first attempt, 60.5% of the patients immediately performed at least one extra recording until sufficient signal quality was achieved, and overall 61.2% of the patients performed at least 2 PPG recordings. Only 69 (15.5%) patients who consented to participation, did not perform any recordings.

Conclusion

This analysis of preliminary GERAF PPG data shows that very old subjects (with a mean age of almost 80 years) are willing and able to use eHealth applications on a mobile device. Most PPG recordings were of sufficient signal quality, and more than half of the patients were willing to perform repeated recordings.
Innovative primary care lead community palpitation management and investigation pathway
Authors: Khan M M , Childe S
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Background

Palpitations are a common reason for General Practitioner (GP) appointment in primary care and a frequent reason for cardiology referral. In the region where this project was performed, this translated to approximately 24,000 primary care and out of hours consultations in 2021 alone.

Purpose

The purpose of this pilot was to evaluate a pathway for palpitations diagnosis and management in primary care. The proposed pathway was designed to avoid unnecessary referrals to secondary care, to shorten the waiting time to diagnosis for patients and to cut down visits to A&E and out of hours service in primary care.

Method

The pathway, which was piloted at a federation for 30,000 patients, was based on a community cardiology approach, where a GP with Special interest in cardiology could offer the service for the wider community. The pathway began with an initial clinical evaluation comprising medical history, physical examination, and a standard 12-lead ECG. After ruling out of any red flags and otherwise deemed appropriate to continue to be assessed with the proposed diagnostic method, the patients were provided with a handheld ECG device for intermittent 30 seconds ECG registration at home. During a four-week investigation period the patients would record their ECG when experiencing symptoms.

The primary care team remotely monitored the traces which were received on a cloud-based system with AI capabilities, and if pathology was recorded, patient was contacted and informed of management plan. If after four weeks no pathology was found, patients received a discharge consultation for reassurance and final report was generated.

Results

During the 24-month pilot we screened the total of 191 patients. Out of the patients screened 24 (13%) were diagnosed with atrial fibrillation, 92 (48%) were diagnosed with benign ectopics as the cause of their palpitations. Two rare occurrences of a life threatening broad complex tachycardias were also detected, both of which ended up needing defib implantation. Table 1. further presents the results by diagnosis for rest of the patients.

Conclusions

The results from the pilot indicated a reduction in GP / out of hours consultations by 50% and over 90% reduction in referral to secondary care for Holter monitoring by implementing an easy-to-use handheld ECG as part of the community led palpitation pathway. The results further implied that a district-wide implementation could lead to at least 120 new AF diagnosis in our project district per year, having a knock-on benefit of stroke reduction and cost economic impact in the society by reducing anxiety, lost employment hours and increasing productivity.

Another key outcome seen is the reassurance value of conducting symptomatic palpitation monitoring to reassure patients, majority of whom had either normal sinus rhythm or benign ventricular ectopics and had failed to be satisfied with conventional Holter monitoring in the past.
Insertable cardiac monitors in high-risk post-infarction patients: a cost-effectiveness analysis
Authors: Villinger J , Cherrey L J , Schreinlechner M , Rizas K D , Bauer A
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Background

The randomised SMART-MI trial demonstrated that telemonitoring with insertable cardiac monitors (ICMs) for post-acute myocardial infarction patients with cardiac autonomic dysfunction and a left ventricular ejection fraction between 35-50% is highly effective in detecting serious arrhythmic events (SAE) compared to standard of care (SoC). In SMART-MI, SAE were also predictive of subsequent major adverse cardiac and cerebrovascular events (MACCE) which might be prevented by preemptive interventions. It is unknown whether such a monitoring strategy would be cost-effective.

Purpose

To evaluate the cost-effectiveness of ICM-based telemonitoring compared to SoC among a UK post-acute myocardial infarction population.

Methods

We created a Markov model to conduct a cost-effectiveness analysis comparing ICMs to SoC for the SMART-MI population. For the analyses, we hypothesized that the SAE-triggered interventions could prevent clinical complications with certain probabilities. A UK National Health System (NHS) perspective was employed with costs and health-related benefits discounted at 3.5%. We employed 6-months Markov cycles and calculated the model over a lifetime horizon. Patient characteristics and detection probabilities were based on the SMART-MI diagnostic study. UK-specific costs and risk-adjusted parameters were used to model the cardiovascular and cerebrovascular pathways. Scenario, deterministic and probabilistic sensitivity analyses were conducted to control for uncertainty.

Results

The base-case scenario found an incremental cost-effectiveness ratio (ICER) of the ICM to be £7,812.92 per QALY gained compared to SoC. There were 0.0646 less ischaemic strokes events per patient and 0.0168 less syncope events per patient in the ICM arm compared to SoC. Results were robust to sensitivity analysis.

Conclusion

Under the assumptions of the study, ICMs were a cost-effective diagnostic tool for detecting arrhythmias compared to SoC, preventing stroke and syncope events in post-acute myocardial infarction patients in the UK.
Validity of device-measured activity in patients with an implantable cardioverter-defibrillator
Authors: Kolk M Z H , Frodi D M , Langford J , Price E , Andersen T O , Niels Risum N , Jacobsen P K , Tan H L , Svendsen J H , Knops R E , Diederichsen S Z , Tjong F V Y
Published: May 2023

Funding Acknowledgements

Type of funding sources: Public grant(s) – EU funding. Main funding source(s): Horizon

Introduction

There is a growing interest in the use of accelerometers and sensors embedded in implantable cardioverter-defibrillators (ICDs) for monitoring patient activity. Despite evidence regarding the potential clinical value of device-measured activity (D-PA), the validity of these measurements has not yet been established.

Objective

To assess the validity of device-measured activity against a research-grade, widely validated wearable accelerometer.

Methods

This is a subanalysis of the ongoing multicenter, prospective SafeHeart study. Raw accelerometry data was continuously sampled at 50Hz from a wrist-worn accelerometer (GENEActiv) during 12 months. Days with at least 22 hours of wear time were used to create summary measures of time in activity, daily active volume and total slow walking steps. These measures were compared to D-PA harmonised as percentage of active time per day, from four different ICD vendors’ remote transmission data, using linear mixed effect models.

Results

Wearable and device-measured activity data in 51 ICD patients rendered 1228 days (mean 24 days ±19) with both wearable and device-measured activity data. There were significant differences between wearable and device-measured accelerometery in the average time active per day (Table 1). For two vendors significant associations between D-PA, daily active volume, and total slow walking steps were observed. Also, associations between D-PA and daily active time and moderate vigorous physical activity were found in a third vendor. For the fourth vendor no association between any wearable activity metric and D-PA was found. Inter-patient differences accounted for 73.1% of the total variance in D-PA.

Conclusion

Results demonstrate substantial differences in device-measured activity measurements compared to research-grade activity data. This has implications for the utility and generalizability of D-PA as clinical parameter.
Developing a patient-centric remote monitoring platform for heart failure: a usability and feasibility pilot
Authors: Kaza N , Sakatsume R , Bachtiger P , Noar A , Miyazawa A , Fudge M , Shun-Shin M J , Keene D
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Background

Implantable cardiac devices can invasively measure physiological markers. Although it was anticipated that these markers could help predict worsening heart failure, results have been conflicting1. However, the Triage-HF Plus study has shown that combining device-derived measures with telephone-based symptom assessment markedly increased sensitivity for detecting worsening heart failure to 98.6%2. Nevertheless, telephone assessment increases clinician workload and is dependent on patient availability. The Care Information Exchange is the largest integrated patient-facing digital care portal in the NHS and is a tool which could be employed in remote monitoring of patient symptoms. We aimed to assess the usability and feasibility of using the Care Information Exchange digital platform for symptom data collection amongst heart failure patients with Heart Failure Risk Score-enabled devices and identify barriers preventing its use so that this could be addressed in the future.

Methods and Results

A digital readiness questionnaire was conducted at enrolment. Weekly symptom questionnaires were sent using the Care Information Exchange platform for up to 5 weeks. Afterwards, semi-structured interviews on the usability and feasibility of the platform were conducted.

Of 131 eligible patients, 87 were successfully contacted, of which 56% enrolled. Reasons for declining to participate included: disinterest (45%), illness (18%) or no device ownership (18%). 53% of those enrolled successfully engaged in one to five symptom questionnaire and the mean weekly adherence rate for the symptom questionnaires was 68% amongst patients who had activated their Care Information Exchange account. Amongst those who engaged, 96% of patients agreed that the digital platform was easy to navigate and 100% agreed that they would be willing to use the platform again for health-related questionnaires. 77% of patients who never engaged did not have activated Care Information Exchange accounts due to barriers such as lack of assistance, technological problems and time constraints.

Conclusion

For the current generation of heart failure patients with devices, feasibility is limited for the digital platform symptom assessment, but the platform was usable in those who engaged. As both clinical services and research trials seek to expand the scope of information which can be collected digitally and remotely, these findings may be used to highlight the steps needed to ensure equitable delivery in making digital health interventions accessible to all patients.
Exosome-mediated targeted delivery of NOX4 siRNA ameliorates angiotensin II-induced atrial fibrillation in mice
Authors: Kang J Y , Mun D S , Chun Y M , Park D S , Kim H E , Yun N R , Joung B Y
Published: May 2023

Funding Acknowledgements

Type of funding sources: Public grant(s) – National budget only. Main funding source(s): National Research Foundation of Korea

Background

Exosomes have gained attention as nanocarrier; however, the poor targeting ability after systemic administration restrict exosomes' clinical application. The targeting ability of exosomes can be improved by surface modifications. Recently, the popular method is the cell engineering technique, but cell engineering processes are complex, high-cost, time-consuming, and labor-intensive. To resolve this problem, several previous reports demonstrated exosomes are directly modified by chemical reactions (e.g., biochemical conjugation or hydrophobic insertion). However, few studies have modified exosomes with targeting ligands for atrial fibrillation.

Purpose

This study aimed to develop exosomes endowed with heart-targeting properties using a fast and easy chemical modification method to serve as a promising therapeutic tool for atrial fibrillation.

Methods

We firstly generated heart-targeted delivery system (CTP-Exo) by engineering the surface of exosomes with cardiac targeting peptide (CTP) using bio-orthogonal copper-free click chemistry. Next, we loaded NOX4 siRNA into CTP-Exo, and NOX4 siRNA-mediated cardioprotective effects were examined in angiotensin II (Ang II)-treated human induced pluripotent stem cell-derived cardiomyocytes (iPSC-CMs) and mice.

Results

CTP-Exo had typical exosome properties, such as ~ 150 nm rounded or cup-shaped morphology, and the presence of marker proteins. Compared with unmodified-Exo, CTP-Exo specifically accumulated in the heart (P < 0.05). In addition, NOX4 siRNA-loaded CTP-Exo (siNOX4/CTP-Exo) exerted strong cardioprotective effects with excellent heart-targeting ability. In Ang II-treated iPSC-CMs, siNOX4/CTP-Exo exhibited the reduced the peak-to-peak interval variability, beating frequency, and Ca2+ transient amplitude. After intravenous injection of siNOX4/CTP-Exo in Ang II-treated mice, there was a significant improvement in cardiac function (P < 0.05) with reduced fibrosis and arrhythmia inducibility.

Conclusion

Taken together, our results suggest that CTP-Exo function as efficient vehicles for heart-targeted delivery of siRNA, which in turn may potentially be used for the treatment of atrial fibrillation.
Genetic background of sinus node dysfunction requiring permanent pacemaker implantation after atrial fibrillation catheter ablation
Authors: Park J W , Hong M H , Kim D H , Yu H T , Kim T H , Uhm J S , Joung B Y , Lee M H , Hwang C , Pak H N
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Introduction

Atrial fibrillation catheter ablation (AFCA) improves sinus node function and may defer a permanent pacemaker (PPM) implantation. We explored the clinical and genetic characteristics of the patients with AF and sinus node dysfunction (SND) who eventually needed PPM implantation after AFCA.

Methods

Among 2,732 AF patients with genome-wide association study (GWAS, PMRA, Thermofisher scientific, MA, USA) data who underwent the first AFCA, 244 patients (65.0, IQR [59.0, 72.0] years, male 58.2%, paroxysmal AF 79.5%) had underlying SND before AFCA (class I indication for PPM). We retrospectively investigated clinical factors, single-nucleotide polymorphisms (SNPs), and their polygenic risk score (PRS) associated with PPM-AFCA. We defined the cut-off of PRS using the Youden index.

Results

During median 37.9 (IQR 20.3-77.9) months follow-up, 36 out of 244 patients (16.1%) with underlying SND eventually underwent PPM implantation after AFCA (PPM-AFCA). PPM-AFCA group a had a higher body mass index (p=0.013) and large left atrial (LA) dimension (p=0.006) than their counterpart. Among 44 SNPs related to AF and SND, the rs3922844 (p=0.003) near SCN5A and rs9320841 (p=0.011) and rs1015451 (p=0.046) near CJA1 were significantly associated with PPM-AFCA. The rate of PPM-AFCA implantation was significantly higher in the high PRS group (≥1.175, 25.6%) compared to the low PRS group (<1.175, 9.38%, p=0.002, Log-rank p=0.002). LA dimension (adjusted HR 1.06, 95% CI [1.00-1.13], p=0.044) and PRS (adjusted HR 2.69, 95% CI [1.68-4.31], p<0.001) were associated with a higher risk for PPM-AFCA after adjusting clinical factors including age, sex, AF type, beta blocker, and antiarrhythmic drugs after AFCA.

Conclusions

In AF patients with SND, 16% with the genetic background of SCN5A and CJA1 or large atrium eventually needed PPM implantation after AFCA.
ECG-patch assessment of atrial fibrillation during the very-early blanking predicts late blanking period recurrence: preliminary data from a prospective registry
Authors: Marques Antunes M , Silva Cunha P , Lacerda Teixeira B , Alves S , Portugal G , Valente B , Delgado A S , Bras M , Coutinho Cruz M , Paulo M , Lousinha A , Guerra C , Cruz Ferreira R , Martins Oliveira M
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Background

Ablation of atrial fibrillation (AF) is a procedure that causes significant atrial tissue lesions, with transient, albeit significant tissue oedema and inflammation. These mechanisms may trigger early rhythm abnormalities that do not necessarily correlate with future arrhythmias, and, therefore, evaluation of AF recurrence is currently validated by routine ECG and ambulatory 24h Holter monitoring, only after a 3-month blanking period. However, recent data have shown that AF episodes occurring during the blanking period are common and may predict late AF recurrences. The E-Patch (Bio Tel Heart) is an innovative, thin single-use adhesive electrode with extended continuous ECG monitoring for up to 120h.

Aim

To assess if continuous extended monitoring in the very-early blanking period can be associated with event recorder data performed in the late blanking period after AF ablation.

Methods

Single-centre, prospective, longitudinal study, including consecutive patients (P) 24h after AF ablation, monitored with the E-patch. The effectiveness of the device in continuously recording within 5 days after ablation was analyzed, as well as the occurrence of AF episodes during an external 7- day loop-recorder, obtained in the 2nd-month post-ablation.

Results

A total of 30P were included (57% male, 63±8 years). AF ablation was performed with radiofrequency (RF) energy in 14P and with a balloon of cryoenergy in 16P. All P were in sinus rhythm at the beginning of the recording. The mean number of hours of recording was 113±16, with no discomfort complaints in the use of the device or interpretation artefacts. During the E-patch monitoring, a total of 10P (33%) presented AF (AF burden 6.8% of the recording, IQR 3.0-20%). All 30P underwent an external loop recorder for 7 days 2 months post-ablation, with 40% showing AF periods (> 30 seconds duration). All 10P that had AF detection in the very-early E-patch recording had also recurrence in the 2 nd month of extended 7-day continuous recording. Very- early AF detection had a sensitivity of 83.3% and a specificity of 100% to detect late blanking period AF (ROC 0.916±0.06; 95%CI 080-1.0).

Conclusions

The use of the E-patch very-early after AF ablation is effective for AF detection and is highly predictive of AF recurrence in the late blanking period. These findings require validation in larger studies to assess the potential of very-early assessment in the determination of a higher risk for AF recurrence.
Artificial intelligence-estimated biological heart age using 12 lead electrocardiogram predicts mortality and cardiovascular outcomes
Authors: Baek Y , Lee D H , Jo Y S , Lee S C , Choi W I , Kim D H
Published: May 2023

Funding Acknowledgements

Type of funding sources: None. Main funding source(s): none

Background

There is a paucity of data on the artificial intelligence-estimated biological ECG heart age (AI ECG-heart age) for predicting cardiovascular outcomes as distinct from the chronological age (CA).

Purpose

We sought to investigate whether a deep learning-based algorithm to estimate the AI ECG-heart age using standard 12-lead ECGs predicted mortality and cardiovascular outcomes.

Methods

We trained and validated a deep neural network using raw ECG digital data from 425,051 12-lead ECGs acquired between January 2006 and December 2021. The network performed a holdout test using a separate set of 97,058 ECGs. Additionally, randomly age-sex matched patients with reduced and preserved ejection fraction (EF) were compared.

Results

The deep neural network was trained to estimate the AI ECG-heart age (the mean absolute error 5.8 ± 3.9 years and R squared of 0.7 (r=0.84, p<0.0001) (Fig 1A). In the Cox proportional-hazards models after adjusting for relevant co-morbidity factors, the subjects with an AI ECG-heart age of seven years older than the chronological age had higher all-cause mortality (HR 1.62 [1.43-1.84]) and major adverse cardiovascular events (MACEs) (HR 1.92 [1.65-2.23]), while those under seven years had an inverse relationship (HR 0.86 [0.77-0.95] for all-cause mortality; HR 0.73 [0.63-0.84] for MACEs) (Fig 2). Subjects with a reduced EF had a substantially higher mean AI ECG heart-age, QRS duration, and corrected QT intervals than those with a preserved EF (all p<0.001) (Fig 1B).

Conclusion

The biological heart age estimated by AI had a significant impact on mortality and MACE. Those data suggested that the AI ECG-heart age might facilitate the primary prevention and health care for cardiovascular outcomes.
Prolonged electrocardiographic monitorization with a wearable system after an embolic stroke of undetermined source
Authors: De Castro D , Jorge Toquero J T R , Diego Jimenez D J S , Eusebio Garcia-Izquierdo E G I , Victor Castro-Urda V C U , Cristina Aguilera-Agudo C A A , Daniel Garcia-Rodriguez D G R , Fernando Hernandez-Terciado F H T , Paula Vela-Martin P V M , Paloma Remior P R P , Andrea Matutano A M M , Ramon Garrido-Gonzalez R G G , Daniel Escribano Garcia D E G , Sergio Garcia-Gomez S G G , Ignacio Fernandez-Lozano I F L
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Background

Embolic cerebrovascular events that remain of unknown etiology after careful diagnostic evaluation are known as Embolic Strokes of Undetermined Source (ESUS). Subclinical atrial fibrillation (AF) is an important cause of ESUS.

Purpose

Our aims were to analyze the global diagnostic yield of a prolonged cardiac monitoring wearable system (PCMw) after an ESUS to detect AF and factors associated with it, including the time frame from the ESUS event to PCMw initiation.

Methods

We retrospectively analyzed 200 ECG recordings (3-leads, 30 days duration) by means of a PCMw in patients with an ESUS to detect AF lasting longer than 30 seconds, between 2017-2021.

Results

AF was detected in 21 patients (10,5 %). Patients with AF had more left atrial enlargement (OR=4,22 [1.59-6.85]; p=0.01) and atrial arrythmias in the initial 24-h Holter during hospitalization (OR=5,73 [2.03-16,49]; p=0.001). The detection of AF was significatively higher if the PCMw was worn within the first 30 days after the ESUS compared to beyond 30 days (17% vs 10,3%; p=0,002).

Conclusion

PCMw represents a feasible non-invasive device that could reliably detect subclinical AF episodes after an ESUS. Diagnostic yield was significatively higher when used within the first 30 days after the event, especially in selected patients.
BIOMONITOR III sensing dependency on Body Mass Index (BMi3 Study): Preliminary results
Authors: Domenichini G , Graf D , Le Bloa M , Teres Castillo C , Carroz P , Herrera-Siklody C , Porretta A P , Pascale P , Pruvot E
Published: May 2023

Funding Acknowledgements

Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): BIOTRONIK SE & Co. KG

Background

Published data on commercially available implantable cardiac monitors (ICMs) and the influence of body mass index (BMI) on the devices sensing performance are scarce. The BIOMONITOR III is an ICM equipped with a large sensing vector allowing to detect high quality subcutaneous ECG (sECG) signals.

Purpose

To evaluate the sensing performance of BIOMONITOR III in two groups of patients (pts) with different BMIs: the first group with BMI>30 (group A) and the second group with BMI<20 (group B).

Methods

The BMi3 is a multicentre, prospective, non-randomized, observational study. The ICM data collection was performed at the implantation and then at 10-days and 3-month follow-up (f-up) visits. A patient questionnaire was conducted at each f-up. The primary end-point was an average R-wave amplitude at f-up end > 0.5 mV in both groups.

Results

A total of 15 pts were included, 10 in group A (8 males, BMI 35.8±3.9) and 5 in group B (2 males, BMI 18.2±1.3). The main implant site was along the heart axis at 45° (70% of pts in group A and 60% of pts of group B), followed by a left parasternal position. The average R-wave amplitude was > 0.5 mV at implant and at each f-up in both groups without significant differences between the groups (see Figure). The P-wave was visible on sECG in all group B pts and in 80% of group A pts. At 3-month f-up the noise burden (detected over the previous 24-h) was 2.6±1.8% in group A vs. 0.0% in group B (p=0.005). Device extraction was performed at the end of the study in 2 pts because of device migration associated to pending erosion (1 pt, group A) or discomfort (1 pt, group A), documented at the 3-months f-up. Overall, the device comfort was reported as "good" or "very good" by 89% of pts in group A vs. 67% of pts in group B (p = ns).

Conclusions

In the BMi3 study the BMI does not significantly affect the R-wave amplitude which remained stable and satisfactory during f-up in both groups. Conversely P-wave visibility on sECG can be reduced in obese pts. Noise is more frequently detected in BMIs > 30 presumably because of difficulties in reaching an implant site allowing minimal device movements in these specific cases. Finally, both skinny and obese pts seem to be a higher risk to experience device migration compared to standard population but larger studies are required to confirm these preliminary observations.
Anatomical and electrophysiological factors involved in atrial cardiomyopathy identify remodeling discrepancies between paroxysmal and persistent atrial fibrillation
Authors: Huang T , Nairn D N , Arentz T A , Jadidi A J
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Background

Progressive atrial fibrotic remodeling has been reported to be associated with atrial cardiomyopathy and the transition from paroxysmal to persistent atrial fibrillation(AF). We sought to identify the anatomical and electrophysiological factors involved in atrial remodeling that promote AF persistency.

Methods

Consecutive patients with paroxysmal(n=134) or persistent(n=136) AF who presented for their first AF ablation procedure were included. Patients underwent high-definition mapping (1835 ± 421 sites/map) during sinus rhythm and were randomized to training and validation sets for model development and evaluation. A total of 62 parameters from both electro-anatomical left atrial(LA) mapping and non-invasive baseline data were extracted encompassing four main categories: (1)LA size, (2)extent of low-voltage-substrate(LVS), (3)LA voltages and (4)bi-atrial conduction time as identified by the duration of amplified P-wave(APWD) in a digital 12-lead-ECG. Least absolute shrinkage and selection operator(LASSO) and logistic regression were performed to identify the factors that are most relevant to AF persistency in each category alone and all categories combined. The performance of the developed models for diagnosis of AF persistency was validated regarding discrimination, calibration and clinical usefulness.

Results

In training and validation sets, APWD (threshold 151ms), LA volume (threshold 94ml), bipolar LVS area <1.0 mV (threshold 4.55cm2) and LA global mean voltage (GMV, threshold 1.66mV) were identified as best determinants for AF persistency in the respective category. Moreover, APWD (AUC 0.851 and 0.801) and LA volume (AUC 0.788 and 0.741) achieved better discrimination than LVS extent (AUC 0.783 and 0.682) and GMV (AUC 0.751 and 0.707). The integrated model (combining APWD and LAV, which were identified after selection among all 62 parameters) yielded the best discrimination performance between AF types (AUC 0.876 in training set and 0.830 in validation set). The calibration performance and clinical usefulness were also superior in APWD and LAV.

Conclusion

Among 62 electro-anatomical parameters, we identified APWD, LA volume, LVS extent and mean LA voltage as the four determinant electrophysiological and anatomical factors that are most indicative for AF persistency. Notably, the combination of APWD with LA volume enabled discrimination between paroxysmal and persistent AF with high accuracy, emphasizing their importance as underlying substrate of persistent AF.
Monitoring for arrhythmia in transthyretin cardiac amyloidosis with remote patch devices
Authors: Bruce S , Cuomo M , Yarmohammadi H , Wan E Y , Saluja D , Sciacca R , Garan H , Griffin J M , Maurer M S , Biviano A B
Published: May 2023

Funding Acknowledgements

Type of funding sources: None.

Background/Introduction

Transthyretin cardiac amyloidosis (ATTR-CA) is associated with an increased incidence of arrhythmias. We hypothesized that non-invasive, two-week outpatient cardiac rhythm monitoring of patients with ATTR-CA would detect high rates of ventricular tachycardia and atrial fibrillation/flutter (AF).

Purpose

To characterize arrhythmia in patients with ATTR-CA on two-week, non-invasive cardiac rhythm monitors.

Methods

38 patients with ATTR-CA (mean age 76.9 SD 10.0 years, 89.5% male) who underwent two-week remote external patch monitoring were included in this single center retrospective study. An age-matched control group included 38 patients (mean age 73.9 SD 12.3, 76.3% male) who underwent the same cardiac rhythm monitoring as part of neurological workups.

Results

NSVT was detected on the remote monitor in 81.6% of ATTR-CA patients and AF was detected in 26.3% of patients. ATTR-CA was associated with higher rates of NSVT and AF compared to the control group (28.9% with NSVT and 5.3% with AF). As seen in Figure 1, there were only three ATTR-CA patients without either AF, NSVT, advanced atrioventricular block, or a significant pause detected on remote monitor. Among the ATTR-CA group, at median 45 weeks follow-up, there were 4 heart failure hospitalizations, 2 cardiovascular events (1 episode of sustained VT and 1 stroke), 6 permanent pacemakers placed, and 3 implantable cardioverter-defibrillators placed, including one for sustained VT. NSVT and AF were not associated with a composite of these adverse outcome.

Conclusion

ATTR-CA was associated with high rates of NSVT and AF on noninvasive remote monitors. While evidence regarding the management of arrhythmias, particularly NSVT/VT, in ATTR-CA remains limited, two-week noninvasive cardiac monitoring can be considered to aid in risk stratification for both atrial and ventricular arrhythmias in ATTR-CA.