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.

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.

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.

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.

The effect of testosterone replacement on endogenous inflammatory cytokines and lipid profiles in hypogonadal men.

Testosterone has immune-modulating properties, and current in vitro evidence suggests that testosterone may suppress the expression of the proinflammatory cytokines TNFalpha, IL-1beta, and IL-6 and potentiate the expression of the antiinflammatory cytokine IL-10. We report a randomized, single-blind, placebo-controlled, crossover study of testosterone replacement (Sustanon 100) vs. placebo in 27 men (age, 62 +/- 9 yr) with symptomatic androgen deficiency (total testosterone, 4.4 +/- 1.2 nmol/liter; bioavailable testosterone, 2.4 +/- 1.1 nmol/liter). Compared with placebo, testosterone induced reductions in TNFalpha (-3.1 +/- 8.3 vs. 1.3 +/- 5.2 pg/ml; P = 0.01) and IL-1beta (-0.14 +/- 0.32 vs. 0.18 +/- 0.55 pg/ml; P = 0.08) and an increase in IL-10 (0.33 +/- 1.8 vs. -1.1 +/- 3.0 pg/ml; P = 0.01); the reductions of TNFalpha and IL-1beta were positively correlated (r(S) = 0.588; P = 0.003). In addition, a significant reduction in total cholesterol was recorded with testosterone therapy (-0.25 +/- 0.4 vs. -0.004 +/- 0.4 mmol/liter; P = 0.04). In conclusion, testosterone replacement shifts the cytokine balance to a state of reduced inflammation and lowers total cholesterol. Twenty of these men had established coronary disease, and because total cholesterol is a cardiovascular risk factor, and proinflammatory cytokines mediate the development and complications associated with atheromatous plaque, these properties may have particular relevance in men with overt vascular disease.

Effect of testosterone therapy on QT dispersion in men with heart failure.

The effects of testosterone on cardiac electrophysiology are poorly described. In this study we report the effect of physiologic testosterone therapy in 2 cohorts of men, the first with stable coronary disease and the second with congestive heart failure. Testosterone reduced QT dispersion in the heart failure cohort; no other effects were observed.