New-generation electronic appliances and cardiac implantable electronic devices: a systematic literature review of mechanisms and in vivo studies.

INTRODUCTION: Cardiac implantable electronic device (CIED) functions are susceptible to electromagnetic interference (EMI) from electromagnetic fields (EMF). Data on EMI risks from new-generation electronic appliances (EA) are limited. OBJECTIVE: We performed a systematic literature review on the mechanisms of EMI, current evidence, and recently published trials evaluating the effect of EMF on CIEDs from electric vehicles (EV), smartphone, and smartwatch technology and summarize its safety data. METHODS: Electronic databases, including PubMed and EMBASE, were searched for in vivo studies evaluating EMF strength and incidence between CIEDs and commercial EVs, new-generation smartphones, and new-generation smartwatches. RESULTS: A total of ten studies (three on EVs, five on smartphones, one on smartphones, one on smartphones and smartwatches) were included in our systematic review. There was no report of EMI incidence associated with EVs or smartwatches. Magnet-containing smartphones (iPhone 12) can cause EMI when placed directly over CIEDs - thereby triggering the magnet mode; otherwise, no report of EMI was observed with other positions or smartphone models. CONCLUSION: Current evidence suggests CIED recipients are safe from general interaction with EVs/HEVs, smartphones, and smartwatches. Strictly, results may only be applied to commercial brands or models tested in the published studies. There is limited data on EMI risk from EVs wireless charging and smartphones with MagSafe technology.

Racial and Ethnic Disparities in Patients Who Underwent Leadless Pacemaker Implantation.

Evidence regarding racial disparities in leadless pacemaker (LP) utilization and outcomes is limited. We aimed to explore ethnicity-based disparities in LP utilization and clinical outcomes of patients who underwent LP implantation. All consecutive patients who underwent LP between January 2019 and January 2023 at our institution were included. Charts were reviewed for baseline characteristics and clinical outcomes. The primary outcomes were procedure-related complications, cardiac rehospitalization, worsening heart failure (HF) or HF hospitalization, and all-cause mortality. All statistical analyses were performed using SPSS Statistics 22 (IBM Corp., Armonk, NY). The p <0.05 was considered statistically significant. A total of 196 adult patients underwent LP implantation during the study period (48% Caucasians, 36.2% Hispanic, 8.2% Asians, and 7.7% African-American). The groups were balanced with respect to baseline demographics, clinical characteristics, and procedure-related complications. During the median follow-up of 104 days (interquartile range 24 to 382), no statistically significant differences were observed in worsening HF or HF hospitalization or all-cause mortality among the ethnic groups. After multivariable logistic regression, Asian individuals had higher odds of cardiac readmissions (odds ratio 4.1, 95% confidence interval 1.4 to 12.3, p = 0.01). Patients from racial and ethnic minorities face significant inequities in arrhythmia care, including patients who have undergone LP implantation. Awareness and a system-based approach (understanding cultural preferences, effective application of evidence-based guidelines, and population-based policies) are crucial to lessen disparities in health care among minorities.

Adverse events associated with amplatzer left atrial appendage occlusion delivery system: A Food and Drug Administration MAUDE database study.

BACKGROUND: Dual occlusive closure mechanism (disc and lobe type), Amulet device (Abbott; a second-generation device that has replaced Amplatzer Cardiac Plug) was approved by the Food and Drug Administration (FDA) in August 2021 for percutaneous left atrial appendage occlusion (LAAO). However, real-world safety data on the delivery system (Amplatzer Cardiac Plug and Amplatzer Amulet device) are lacking. OBJECTIVE: We sought to assess the type of adverse events associated with the Amplatzer LAAO delivery system using the FDA Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: A MAUDE database search was conducted on March 31, 2023, for reports received between February 2013 and March 2023 to capture all adverse events. RESULTS: A total of 59 adverse events were reported, of which 58 were sheath-related events, and one was a wire-related event. The most commonly encountered issue was air embolism (19%, 11 events), followed by sheath thrombosis (13.8%, eight events, two of which were also associated with device thrombosis), kinked sheath (10.3%, six events), and sheath deformation (8.6%, five events). Patient-related adverse events included pericardial effusion requiring pericardiocentesis (22.4%, 13 events), vascular complications (20.7%, 12 events), and device dislodgement (5.2%, three events). CONCLUSION: LAAO-related adverse events are increasingly being reported using the Amplatzer LAAO delivery sheath. It is anticipated that improvements in device technology, the advent of steerable sheaths, and operator experience will minimize these complications.

Adverse events associated with AveirTM VR leadless pacemaker: A Food and Drug Administration MAUDE database study.

BACKGROUND: Leadless pacemaker (LP) offers an innovative approach for treating bradyarrhythmia, thus avoiding pacemaker pocket and lead-related complications. The Food and Drug Administration (FDA) has recently approved the Aveir™ leadless pacing system (screw-in type LP). METHODS: We queried the FDA MAUDE database to study the safety profile and assess the types of complications with this relatively novel device technology. A MAUDE database search was conducted on January 20, 2023, for reports received post-FDA approval to capture all adverse events. RESULTS: A total of 98 medical device report were reported for Aveir™ LP. After excluding duplicate, programmer-related, or introducer-sheath-related entries (n = 34), 64 entries were included. The most commonly encountered problem was high threshold/noncapture (28.1%, 18 events), followed by stretched helix (17.2%, 11 events) and device dislodgement (15.6%, ten events-5 intraprocedural, while 5 in the postoperative Day 1). Other reported events included high impedance (14.1%, nine events), sensing issues (12.5%, eight events), bent/broken helix (7.8%, five events), premature separation (4.7%, three events), interrogation problem (3.1%, two events), low impedance (3.1%, two events), premature battery depletion (1.6%, one event) and inadvertent MRI mode switch (1.6%, one event) and miscellaneous (15.6%, n = 10). There were eight serious patient injury events-pericardial effusion requiring pericardiocentesis (7.8%, five events) due to cardiac perforation that resulted in two deaths (3.1%) followed by sustained ventricular arrhythmias (4.6%, n = 3). CONCLUSION: In our study assessing the real-world safety profile of the Aveir™ LP, serious adverse events have been reported-life-threatening ventricular arrhythmias, pericardial effusion, device explantation/reimplantation, and death.

Conduction system pacing in prosthetic heart valves.

BACKGROUND: There has been increasing interest in physiologic pacing techniques that directly activate the specialized conduction system. We aimed to assess outcomes of conduction system pacing (CSP) in patients with prosthetic heart valves. METHODS: This systematic review was performed according to PRISMA guidelines. Freeman-Tukey double arcsine transformation with the random-effect model was used to summarize the data. Outcomes studied were 1) implant success (defined as ability to recruit the His-Purkinje system or the distal Purkinje system); (2) lead parameters at implant and follow-up; and (3) procedure-related complications. RESULTS: This systematic review of 7 studies included 267 unique patients in whom CSP was attempted with either HBP or LBBAP for pacing indications after a prosthetic valve. HBP was attempted in 38% (n = 108), while LBBAP in 62% (n = 175) patients. The overall success rate of CSP was 87%, while in patients post-TAVR, the overall success rate was 83.2%. In the subgroup analysis, LBBAP had a significant higher overall success rate compared to HBP (94.3% vs. 76.5%, p interaction = 0.02) and post-TAVR patients (94.3 vs. 66.9%, p interaction < 0.01), respectively. The LBBAP thresholds were significantly lower compared to HBP both at implant (0.67 ± 0.4 @ 0.44 ms vs. 1.35 ± 1 @ 0.85 ms, p interaction < 0.01) and at a mean follow-up of 12.4 ± 8 months (0.73 ± 0.1 @ 0.44 ms vs. 1.39 ± 1 @ 0.85 ms, p interaction < 0.01), respectively. CONCLUSION: CSP is safe and feasible in patients with a prosthetic valve, with a significantly higher success rate and superior lead parameters with LBBAP than HBP, especially in patients post-TAVR.

Clinical outcomes of radiofrequency catheter ablation of ventricular tachycardia in patients with hypertrophic cardiomyopathy.

BACKGROUND: Monomorphic ventricular tachycardia (VT) is rare in patients with hypertrophic cardiomyopathy (HCM), management of which is challenging. Limited data exists on the utility of catheter ablation for the treatment of VT in this population. OBJECTIVES: We aimed to assess clinical outcomes of catheter ablation for VT in HCM patients. METHODS: A systematic search, without language restriction, using PubMed, EMBASE, SCOPUS, Google Scholar, and ClinicalTrials.gov was performed. The meta-analysis was performed using a meta-package for R version 4.0/RStudio version 1.2 and Freeman Tukey double arcsine method to establish the variance of raw proportions. Outcomes measured included (1) acute procedure success (defined as noninducible for clinical VT), (2) freedom from VT at follow-up, (3) mortality. RESULTS: This systematic review of six studies (three from the United States and three from Japan) incorporated a total of 68 drug-refractory HCM patients who underwent VT radiofrequency catheter ablation (mean age 57.6 ± 13.3 years, mean LVEF 45.8 ± 15.4%, 85% men, maximum septal wall thickness 17.4 ± 4.6 mm, and 32.3% with an apical aneurysm). Acute procedural success was achieved in 84.5% patients (95% confidence interval [CI]: 70.6%-95.2%) with 27.9% patients had recurrent VT requiring multiple ablations (median 1, IQR 1-3). During the follow-up period (18.3 ± 11.7 months), the pooled incidence of freedom from recurrent VT after index procedure was 70.2% (95% CI: 51.9%-86.2%), while after the last ablation was 82.8% (95% CI: 57%-99.2%). There were two deaths during follow-up, one from heart failure and one from SCD 0.8% (95% CI: 0%-5.8%). CONCLUSION: The results of our pooled analysis demonstrated that catheter ablation for VT in HCM patients was associated with high acute procedural success, and reduced VT recurrence-findings comparable to previously published reports in other disease substrates.

Intracardiac echocardiography from coronary sinus.

Intracardiac echocardiography (ICE) has become an essential tool and is an integral part of percutaneous interventional and electrophysiology (EP) procedures. Intracardiac echocardiography offers real-time, high-quality, near-field evaluation of cardiac anatomy. Standard ICE imaging includes placing the catheter in the right atrium (RA), right ventricle (RV), or left atrium (LA, via the transeptal approach). Coronary sinus echocardiography (CSE) is another alternative, where the ICE catheter is positioned in the coronary sinus (CS). This approach offers better catheter stability and allows operators to visualize cardiac structure with particularly excellent views of the LA, LAA, left ventricle (LV), and mitral annulus. Additionally, CSE is an attractive alternative in cases with unfavorable interatrial septum or fossa ovalis anatomical features that could lead to difficulty advancing ICE catheter in left atrium. In this article focusing on CSE, we provide illustration-based guidance to help operators identify critical cardiac structures from CSE.

Multidisciplinary Approach to Hemodynamic Management During High-Risk Ventricular Tachycardia Ablation.

Percutaneous ventricular assist devices have been used for high-risk ventricular tachycardia ablation when hemodynamic decompensation is expected. Utilizing a case example, we present our experience with development of a coordinated, team-based approach focused on periprocedural management of patients with high-risk ventricular tachycardia. (Level of Difficulty: Advanced.).