Safety of the colonoscope magnetic imaging device (ScopeGuide) in patients with implantable cardiac devices.

BACKGROUND AND STUDY AIMS: Use of the colonoscope magnetic imaging device (ScopeGuide, Olympus Medical Systems, Tokyo, Japan) is currently contraindicated by the manufacturer for patients with implantable cardiac devices, a group of patients that is increasing annually along with the number of colonoscopies performed in the era of colorectal cancer screening. This is the first study to examine the safety of ScopeGuide in patients with permanent pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization therapy. PATIENTS AND METHODS: Nonimplanted cardiac devices were exposed to the electromagnetic field of ScopeGuide ex vivo and assessed for evidence of interference or change in device settings. Following this, consecutive patients attending device check clinics were prospectively recruited and exposed to the ScopeGuide electromagnetic field. After an initial device check, patients underwent continuous external cardiac monitoring and device interrogation while a colonoscope was placed on the abdomen over clothing and connected to ScopeGuide to simulate colonoscopy. Patients were monitored for 2 minutes to assess for any interference. ScopeGuide was then disconnected and devices were checked for any change in settings. RESULTS: A total of 230 patients were invited to participate and 100 were recruited to the study. There was no evidence of interference on device leads or change in programming following exposure to the electromagnetic field generated by ScopeGuide. CONCLUSION: ScopeGuide does not appear to cause interference or change in settings and is therefore likely to be safe for use in patients with implantable cardiac devices.

Location, Location, Location: A Pilot Study to Compare Electrical with Echocardiographic-Guided Targeting of Left Ventricular Lead Placement in Cardiac Resynchronisation Therapy.

Introduction: Cardiac resynchronisation therapy is ineffective in 30-40% of patients with heart failure with reduced ejection fraction. Targeting non-scarred myocardium by selecting the site of latest mechanical activation using echocardiography has been suggested to improve outcomes but at the cost of increased resource utilisation. The interval between the beginning of the QRS complex and the local LV lead electrogram (QLV) might represent an alternative electrical marker. Aims: To determine whether the site of latest myocardial electrical and mechanical activation are concordant. Methods: This was a single-centre, prospective pilot study, enrolling patients between March 2019 and June 2021. Patients underwent speckle-tracking echocardiography (STE) prior to CRT implantation. Intra-procedural QLV measurement and R-wave amplitude were performed in a blinded fashion at all accessible coronary sinus branches. Pearson's correlation coefficient and Cohen's Kappa coefficient were utilised for the comparison of electrical and echocardiographic parameters. Results: A total of 20 subjects had complete data sets. In 15, there was a concordance at the optimal site between the electrically targeted region and the mechanically targeted region; in four, the regions were adjacent (within one segment). There was discordance (≥2 segments away) in only one case between the two methods of targeting. There was a statistically significant increase in procedure time and fluoroscopy duration using the intraprocedural QLV strategy. There was no statistical correlation between the quantitative electrical and echocardiographic data. Conclusions: A QLV-guided approach to targeting LV lead placement appears to be a potential alternative to the established echocardiographic-guided technique. However, it is associated with prolonged fluoroscopy and overall procedure time.

Perceived benefits of patient support groups and their format for people with an implantable cardioverter defibrillator.

BACKGROUND: Support groups for people with Implantable Cardioverter Defibrillators (ICDs) are widely used, however, it is not clear what people with ICDs gain from a support group or what format they should take. OBJECTIVES: The aim of the present study is to define the perceived benefit of ICD support groups and develop practical recommendations for group format. METHODS: 14 individuals with ICDs were interviewed using a semi-structured interview guide. Reflexive thematic analysis methods were utilised to code and analyse the transcripts before generating themes. RESULTS: Four themes were defined: confronting mortality, coping through sharing, coping through learning, and providing space. Making connections with other people with ICDs, reassurance, access to information, and advice from health care professionals were important perceived benefits of the support group. CONCLUSION: People with ICDs may have to confront their own mortality and adapt to considerable life changes after implant. The findings from the present study have improved understanding of how support groups are perceived and how ICD indication and group format influence the experience. A blended format of in-person community meetings, online forums, HCP-led education and space for person-person interaction is recommended. Importantly, provision of support should not be time-limited to allow people to access it when it most likely to be of benefit to them.

The incidence of atrial fibrillation detected by implantable loop recorders: a comparison between patients with and without embolic stroke of undetermined source.

Aims: Stroke is the most debilitating outcome of atrial fibrillation (AF). The use of implantable loop recorders increases the detection of AF episodes among patients with embolic stroke of undetermined source. The significance of device-detected AF, or subclinical AF, is unknown. This study aimed to compare the incidence of AF detected by implantable loop recorder in patients with and without embolic stroke of undetermined source. Methods and results: We retrospectively studied all patients without known AF who were referred to our institution for implantable loop recorder implantation following embolic stroke of undetermined source, syncope, or palpitations from March 2009 to November 2019. The primary endpoint was any detection of AF or atrial flutter by implantable loop recorder. Seven hundred and fifty patients were included and followed up for a mean duration of 731 days (SD 443). An implantable loop recorder was implanted following embolic stroke of undetermined source in 323 and for assessment of syncope, palpitations, or another reason in 427 patients. The incidence of AF was significantly (P < 0.001) higher among patients with embolic stroke of undetermined source compared with the non-embolic stroke of undetermined source group; 48.6% vs. 13.8% (for any duration of AF) and 32.2% vs. 12.4% (for AF lasting ≥30 s) both P < 0.001. Kaplan-Meier analysis showed significantly higher incidence of AF for incremental durations of AF up to >5.5 h, but not >24 h. This was driven by longest AF durations of <6 min and between 5.5 h and 24 h, suggesting a bimodal distribution. In a multivariable Cox regression analysis, embolic stroke of undetermined source independently conferred an almost 5-fold increase in the hazard for any duration of AF. Conclusion: The incidence of AF is significantly higher amongst embolic stroke of undetermined source vs. non-embolic stroke of undetermined source patients monitored constantly by an implantable loop recorder. A high number of embolic stroke of undetermined source survivors have short-duration AF episodes. Further work is needed to determine the optimal treatment strategy of these AF episodes in embolic stroke of undetermined source.

Electrocardiographic Predictors of Atrial Fibrillation.

BACKGROUND: Atrial fibrillation (AF) is the most common pathological arrhythmia, and its complications lead to significant morbidity and mortality. However, patients with AF can often go undetected, especially if they are asymptomatic or have a low burden of paroxysms. Identification of those at high risk of AF development may help refine screening and management strategies. METHODS: PubMed and Embase databases were systematically searched for studies looking at electrocardiographic predictors of AF from inception to August 2021. RESULTS: A total of 115 studies were reported which examined a combination of atrial and ventricular parameters that could be electrocardiographic predictors of AF. Atrial predictors include conduction parameters, such as the PR interval, p-wave index and dispersion, and partial interatrial or advanced interatrial block, or morphological parameters, such as p-wave axis, amplitude and terminal force. Ventricular predictors include abnormalities in QRS amplitude, morphology or duration, QT interval duration, r-wave progression and ST segment, i.e., t-wave abnormalities. CONCLUSIONS: There has been significant interest in electrocardiographic prediction of AF, especially in populations at high risk of atrial AF, such as those with an embolic stroke of undetermined source. This review highlights the breadth of possible predictive parameters, and possible pathological bases for the predictive role of each parameter are proposed.

Exploring the Temporal Patterns of Right Ventricular Pacing Burden.

Elevated right ventricular pacing (RVP) burdens are associated with the development of pacing-induced cardiomyopathy. This association is alluded to in the recent European and American pacing guidelines where anticipated pacing burden forms part of the indications for conduction system pacing. Understanding the temporal pattern of RVP burden is important with respect to anticipating future burden and ensuring that the most appropriate pacing modality is selected for patients. To the best of our knowledge, this is the first study to assess how RVP burden changes over time in different pacing indications. A retrospective, single-center, observational study was performed. RVP burdens from pacing checks were extracted and plotted against 6-month time "bins." Graphical plots of RVP burdens for different pacing indications were produced. There was no significant change in the RVP burden across time, independent of the initial pacing indication. Individuals with sinus node disease (SND) and a P-R interval of >250 ms had increased RVP burden. Other than patients with SND and a P-R interval of <250 ms, individuals had pacing burdens higher than those proposed in both the European and American pacing guidelines for conduction system pacing.

Atrial fibrillation in embolic stroke of undetermined source: role of advanced imaging of left atrial function.

AIMS: Atrial fibrillation (AF) is detected in over 30% of patients following an embolic stroke of undetermined source (ESUS) when monitored with an implantable loop recorder (ILR). Identifying AF in ESUS survivors has significant therapeutic implications, and AF risk is essential to guide screening with long-term monitoring. The present study aimed to establish the role of left atrial (LA) function in subsequent AF identification and develop a risk model for AF in ESUS. METHODS AND RESULTS: We conducted a single-centre retrospective case-control study including all patients with ESUS referred to our institution for ILR implantation from December 2009 to September 2019. We recorded clinical variables at baseline and analysed transthoracic echocardiograms in sinus rhythm. Univariate and multivariable analyses were performed to inform variables associated with AF. Lasso regression analysis was used to develop a risk prediction model for AF. The risk model was internally validated using bootstrapping. Three hundred and twenty-three patients with ESUS underwent ILR implantation. In the ESUS population, 293 had a stroke, whereas 30 had suffered a transient ischaemic attack as adjudicated by a senior stroke physician. Atrial fibrillation of any duration was detected in 47.1%. The mean follow-up was 710 days. Following lasso regression with backwards elimination, we combined increasing lateral PA (the time interval from the beginning of the P wave on the surface electrocardiogram to the beginning of the A' wave on pulsed wave tissue Doppler of the lateral mitral annulus) [odds ratio (OR) 1.011], increasing Age (OR 1.035), higher Diastolic blood pressure (OR 1.027), and abnormal LA reservoir Strain (OR 0.973) into a new PADS score. The probability of identifying AF can be estimated using the formula. Model discrimination was good [area under the curve (AUC) 0.72]. The PADS score was internally validated using bootstrapping with 1000 samples of 150 patients showing consistent results with an AUC of 0.73. CONCLUSION: The novel PADS score can identify the risk of AF on prolonged monitoring with ILR following ESUS and should be considered a dedicated risk stratification tool for decision-making regarding the screening strategy for AF in stroke.

One-third of patients with a type of stroke called embolic stroke of undetermined source (ESUS) also have a heart condition called atrial fibrillation (AF), which increases their risk of having another stroke. However, we do not know why some patients with ESUS develop AF. To figure this out, we studied 323 patients with ESUS and used a special device to monitor their heart rhythm continuously for up to 3 years, an implantable loop recorder. We also looked at their medical history, performed a heart ultrasound, and identified some factors that increase the risk of identifying AF in the future. Factors associated with future AF include older age, higher diastolic blood pressure, and problems with the co-ordination and function of the upper left chamber of the heart called the left atrium.Based on these factors, we created a new scoring system that can identify patients who are at higher risk of developing AF better than the current scoring systems, the PADS score. This can potentially help doctors provide more targeted and effective treatment to these patients, ultimately aiming to reduce their risk of having another stroke.

The predictive value of abnormal P-wave axis for the detection of incident atrial fibrillation: A systematic review with meta-analysis.

INTRODUCTION: There is growing interest in the prediction of incident atrial fibrillation (AF). The 12-lead electrocardiogram (ECG) has been a particularly rich target for possible prediction strategies. PURPOSE: The P-wave axis is an ECG parameter that reflects the dominant vector of atrial depolarisation and is usually 0° -75°. There is a large body of literature suggesting that AF reflects structural and conduction abnormalities of the atria, and thus the P-wave axis may represent a sensitive parameter to detect such changes. METHODS: A systematic review and meta-analysis of published literature associating abnormal P-wave axis and the development of incident AF was performed. Electronic databases were systematically searched from inception to October 2021. A random-effects model with generic inverse variance weights was utilised to pool the most adjusted effect measure from each paper. A funnel plot was used to assess publication bias. RESULTS: After excluding duplicate studies, 568 studies were screened. A total of eleven studies were identified that associated an abnormal P-wave axis with the subsequent detection of AF. The eight studies that considered abnormal P-wave axis as being <0° or >75° were pooled for meta-analysis. In the pooled studies a total of 78,222 patients were included with 5656 cases of incident atrial fibrillation identified. The meta-analysis of the studies suggested that an abnormal P-wave axis was associated with a pooled risk ratio of 2.12 (95% CI 1.49 to 3.01) for the detection of incident atrial fibrillation. CONCLUSION: This comprehensive systematic review and meta-analysis, indicates the positive association of abnormal P wave axis and future detection of AF. Utilisation of abnormal P-wave axis, alongside other parameters, may allow clinicians to better risk-stratify individuals at increased risk of AF, and thus identify those who may benefit most from prolonged cardiac monitoring or targeted anticoagulation.

Benefits of support groups for patients living with implantable cardioverter defibrillators: a mixed-methods systematic review and meta-analysis.

BACKGROUND: Patients with implantable cardioverter defibrillators (ICD) experience anxiety, depression and reduced quality of life (QoL). OBJECTIVES: This mixed-methods systematic review evaluates whether ICD support groups have a beneficial effect on mental well-being. METHODS: Literature searches were carried out in MEDLINE, Embase, CINAHL, PsycINFO and Web of Science. Eligible studies investigated patient-led support groups for ICD patients aged 18 years or older, using any quantitative or qualitative design. The Mixed-Methods Assessment Tool was used to assess quality. Meta-analysis of measures of mental well-being was conducted. Thematic synthesis was used to generate analytic themes from the qualitative data. The data were integrated and presented using the Pillar Integration Process. RESULTS: Ten studies were included in this review. All studies bar one were non-randomised or had a qualitative design and patients had self-selected to attend a support group. Five contributed to the quantitative data synthesis and seven to the qualitative synthesis. Meta-analysis of anxiety and QoL measures showed no significant impact of support groups on mental well-being, but qualitative data showed that patients perceived benefit from attendance through sharing experiences and acceptance of life with an ICD. DISCUSSION: ICD support group attendance improved the patients' perceived well-being. Attendees value the opportunity to share their experiences which helps to accept their new life with an ICD. Future research could consider outcomes such as patient acceptance and the role of healthcare professionals at support groups.

Service Evaluation of the Impact of Capnography on the Safety of Procedural Sedation.

Background: Capnography has been associated with a reduced incidence of events related to respiratory compromise during procedural sedation. Methods: A prospective service evaluation was conducted at a large United Kingdom (UK) teaching hospital to assess the impact of capnography on patient safety within four speciality services: bronchoscopy, endoscopy, interventional cardiology, and interventional radiology. Events were defined as provided by the World Society of Intravenous Anaesthesia. One thousand four hundred one patients were enrolled in the evaluation, with 666 patients before and 735 after implementation of capnography. Data was entered as a convenience sample on site in an offline data-collection tool. Results were assessed for the relative reduction in the incidence and resulting adjusted odds ratio for the combined incidence of oxygen desaturation (75-90% for <60s), severe oxygen desaturation (<75% at any time) or prolonged oxygen desaturation (<90% for >60s), bradycardia (>25% from baseline) and tachycardia (>25% from baseline). The adjusted odds ratio was controlled for both procedure and patient characteristics. Results: After implementation of capnography, a significant reduction (43.2%, p ≤ 0.05) in adverse events was observed: 147 adverse events occurred during 666 procedures without capnography compared with 93 adverse events that occurred during 735 procedures with capnography. The adjusted odds ratio for the occurrence of the target adverse events was 0.57 (95% CI: 0.42-0.77). Multivariable linear regression indicated that capnography was a significant predictor (p 0.001) of reduced adverse events. Conclusion: These results suggest improved patient safety following capnography implementation.

Corrigendum: Service evaluation of the impact of capnography on the safety of procedural sedation.

[This corrects the article DOI: 10.3389/fmed.2022.867536.].

Recurrence of B-cell lymphoma within an implantable cardioverter defibrillator wound scar.

A 79-year-old man presented with relapse of non-Hodgkin's B-cell lymphoma within the scar from his implantable cardioverter defibrillator (ICD) implantation. The ICD was re-sited before he proceeded to chest wall radiotherapy, which resulted in complete remission of the lymphoma. This is the first reported case of lymphoma recurrence within an ICD wound scar.

Impact of VV optimization in relation to left ventricular lead position: an acute haemodynamic study.

AIMS: Left ventricular (LV) lead placement to the most delayed segment offers the greatest potential benefit to cardiac resynchronization therapy (CRT). We assessed the impact of interventricular (VV) optimization on acute changes in cardiac output (CO) in patients with and without LV pacing of the most delayed segment. METHODS AND RESULTS: In 124 patients, the most delayed segment was defined by speckle tracking radial strain and the LV lead position by biplane fluoroscopy. Patients were classified as either a concordant (LV lead at latest site), adjacent (within one segment), or remote (two or more segments away) LV lead. Atrioventricular (AV) and VV delays were optimized by echocardiography. Cardiac output was measured non-invasively and a >20% increase in CO from baseline (intrinsic) defined acute response. Changes in CO in patients with concordant, adjacent, or remote LV leads were recorded following atrioventricular optimization alone (AV OPT) and after combined AV and VV optimization (AV/VV OPT). Compared with AV OPT pacing, AV/VV OPT produced a greater rise in CO (5.45 ± 1.1 vs. 5.76 ± 1.2 L/min, P< 0.001) and higher acute response rates (48.4 vs. 61.3%, P= 0.041). In adjacent patients, compared with AV OPT pacing, AV/VV OPT settings increased the response rate from 36.4 to 63.6% (P= 0.037). VV optimization had no effect on acute response rates in patients with remote (26.7 vs. 33.3%, P = 0.581) or concordant LV leads (65.6 vs. 72.1%, P = 0.438). CONCLUSION: VV optimization overcomes some but not all of the deleterious effects of a suboptimal LV lead position.

Cardiac resynchronization therapy optimization using noninvasive cardiac output measurement.

AIMS: Noninvasive cardiac output (CO) measurement (NICOM) is a novel method to assess ventricular function and offers a potential alternative for optimization of cardiac resynchronization therapy (CRT) devices. We compared the effect of NICOM-based optimization to no optimization (empiric settings) on CRT outcomes. METHODS: Two hundred and three patients undergoing CRT were assessed in two consecutive nonrandomized groups; an empiric group (n = 54) was programmed to "out of the box" settings with a fixed AV delay of 120 ms and a VV delay of 0 ms; and the optimization group (n = 149) underwent adjustments of both the AV and VV delays according to the greatest improvement in resting CO. The primary endpoints were improvements in left ventricular (LV) volumes and function from baseline at 6 months. Secondary endpoints were change in New York Heart Association (NYHA) class, quality of life score, and 6-minute walk test (6 MWT) performance. RESULTS: After 6 months of CRT, the optimization group had a better clinical response with lower NYHA class (2.1 ± 0.8 vs 2.4 ± 0.8, P = 0.048) and quality of life scores (35 ± 18 vs 42 ± 20, P = 0.045) but no differences in 6-MWT performance (269 ± 110 vs 277 ± 114 m, P = 0.81). Echocardiographic response was also better in the optimization group with lower LV end systolic volume (108 ± 51 vs 126 ± 60 mL, P = 0.048) and higher ejection fraction (30 ± 7 vs 27 ± 8, P = 0.01) compared to empiric settings. CONCLUSION: Device optimization using noninvasive measures of CO is associated with better clinical and echocardiographic response compared to empiric settings.

The impact of the right ventricular lead position on response to cardiac resynchronization therapy.

INTRODUCTION: Left ventricular (LV) lead placement to the latest contracting area (concordant LV lead) is associated with better response to cardiac resynchronization therapy (CRT) compared to a discordant LV lead. However, the effect of the right ventricular (RV) lead site on CRT response is unclear. We investigated the relationship of the RV and LV lead positions on CRT response. METHODS: In 131 CRT patients, the LV lead was positioned preferentially in a lateral or posterolateral vein and the RV lead to either the RV septum (RVS, n = 55) or RV apex (RVA, n = 76). The latest site of contraction was determined with two-dimensional speckle tracking radial strain imaging and patients had a concordant LV lead position if pacing the latest segment, and discordant if not. Response was defined as ≥15% reduction in LV end systolic volume (LVESV) at 6-month follow-up. RESULTS: There were no significant differences in mean reduction of LVESV at follow-up (RVS vs RVA: -23.3 ± 16% vs 22.1 ± 18%, P = 0.70) or rate of responders (58.2% vs 57.9%, P = 0.97) between the two groups. In patients with a concordant LV lead (n = 71), the response rate was significantly higher than those with a discordant lead (76.1% vs 36.7%, P < 0.001). There were no differences in outcomes in patients with a concordant or discordant LV lead according to the RV lead location. CONCLUSION: The extent of LV reverse remodeling following CRT is not related to the RV lead position, but is significantly higher in patients with a concordant LV lead.

Non-invasive cardiac output measurements based on bioreactance for optimization of atrio- and interventricular delays.

AIMS: Non-invasive cardiac output monitoring (NICOM) based on bio-reactance offers a portable method to assess ventricular function. Optimization of cardiac resynchronization therapy (CRT) by echocardiography is labour-intensive. We compared the ability of NICOM and echocardiography to facilitate optimum CRT device programming. METHODS AND RESULTS: Forty-seven patients in sinus rhythm were evaluated within 14 days of CRT implantation. The atrio- (AV) and interventricular (VV) delay intervals were incrementally adjusted and at each setting, NICOM and echocardiographic data were recorded. Left ventricular (LV) volumes and function were assessed by echocardiography at baseline and 3 months. Response to CRT was defined as a reduction in LV end-systolic volume (LVESV) by >15%. In all patients, cardiac output (CO) increased significantly at optimized settings compared with baseline (5.66 +/- 1.4 vs. 4.35 +/- 1.1 L/min, P < 0.001). A 20% increase in acute CO following CRT predicted LVESV reduction of >15% with a sensitivity of 81% and specificity of 92% (AUC 0.86). The optimum AV delay determined by NICOM was confirmed by echocardiography in 40 of 47 patients (85%, r = 0.89, P < 0.01) and for VV delay in 39 of 47 patients (83%, r = 0.89, P < 0.01). CONCLUSION: Non-invasive cardiac output monitoring is a simple, reliable, and portable alternative to echocardiography to program CRT devices.

Managing anticoagulation in patients receiving implantable cardiac devices.

A substantial proportion of patients who undergo cardiac device implantation receive oral anticoagulation to prevent thromboembolism or antiplatelets to prevent thrombotic events. Anticoagulation and antiplatelets increase the risk of hemorrhagic complications, while discontinuation may increase thromboembolic risk and thrombotic events. With the introduction of non-vitamin K antagonist oral anticoagulant agents and the newer antiplatelet agents such as prasugrel or ticagrelor, the perioperative management of patients has become more challenging. In this article, we review the recent trials and meta-analysis and describe the available evidence, as well as the current recommendations in order to inform best practice. We also reinforce the importance of further trials in this complex and rapidly evolving area.

An open-label study to assess the feasibility and tolerability of rilmenidine for the treatment of Huntington's disease.

Preclinical data have shown that rilmenidine can regulate autophagy in models of Huntington's disease (HD), providing a potential route to alter the disease course in patients. Consequently, a 2-year open-label study examining the tolerability and feasibility of rilmenidine in mild-moderate HD was undertaken. 18 non-demented patients with mild to moderate HD took daily doses of 1 mg Rilmenidine for 6 months and 2 mg for a further 18 months followed by a 3-month washout period. The primary outcome was the number of withdrawals and serious adverse events. Secondary outcomes included safety parameters and changes in disease-specific variables, such as motor, cognitive and functional performance, structural MRI and serum metabolomic analysis. 12 patients completed the study; reasons for withdrawal included problems tolerating study procedures (MRI, and venepuncture), depression requiring hospital admission and logistical reasons. Three serious adverse events were recorded, including hospitalisation for depression, but none were thought to be drug-related. Changes in secondary outcomes were analysed as the annual rate of change in the study group. The overall change was comparable to changes seen in recent large observational studies in HD patients, though direct statistical comparisons to these studies were not made. Chronic oral administration of rilmenidine is feasible and well-tolerated and future, larger, placebo-controlled, studies in HD are warranted. TRIAL REGISTRATION: EudraCT number 2009-018119-14.