Catheter-related and clinical complications associated with QDOT MICROTM Ablation Catheter.

INTRODUCTION: The QDOT MICROTM Ablation Catheter is a next-generation ablation catheter that allows for high-power ablation up to 90 watts. METHODS: We aimed to assess AE associated with the QDOT MICROTM catheter using the MAUDE database. A MAUDE database search was conducted on May 25, 2024, to capture all AEs (since FDA approval) associated with this ablation catheter. RESULTS: A total of 302 AEs from November 23, 2022, to April 30, 2024, were reported including 148 (49%) catheter-related issues and 154 (51%) clinical complications. Among the catheter-related issues, physical catheter damage (74.3%, n = 110) was most common, followed by communication or display issue (10.8%, n = 16), irrigation issue (9.5%, n = 14), signal issue or artifact (3.4%, n = 5), and inaccurate temperature measurement (2.0%, n = 3). Regarding clinical complications, the most common AE was pericardial effusion (43.5%, n = 67), followed by char formation (11.7%, n = 18), catheter thrombosis (7.1%, n = 11), stroke (7.1%, n = 11), pericarditis (7.1%, n = 11), esophageal complications (6.5%, n = 10), phrenic nerve palsy (3.9%, n = 6), cardiac arrest (3.9%, n = 6), significant AV block (3.9%, n = 6), pulmonary vein stenosis (3.2%, n = 5), coronary artery spasm (1.3%, n = 2), and pulmonary embolism (0.6%, n = 1). There were 11 deaths (five related to esophageal complications, five related to cardiac arrest, and one related to pericardial effusion with cardiac tamponade). CONCLUSION: As high-power ablation strategy with novel ablation catheters is becoming more widely utilized, operators must be aware of potential catheter-related issues and clinical complications that may arise. More data are needed to further evaluate risks of these complications to improve the catheter's safety and efficacy.

Mechanisms of action behind the protective effects of proactive esophageal cooling during radiofrequency catheter ablation in the left atrium.

Proactive esophageal cooling for the purpose of reducing the likelihood of ablation-related esophageal injury resulting from radiofrequency (RF) cardiac ablation procedures is increasingly being used and has been Food and Drug Administration cleared as a protective strategy during left atrial RF ablation for the treatment of atrial fibrillation. In this review, we examine the evidence supporting the use of proactive esophageal cooling and the potential mechanisms of action that reduce the likelihood of atrioesophageal fistula (AEF) formation. Although the pathophysiology behind AEF formation after thermal injury from RF ablation is not well studied, a robust literature on fistula formation in other conditions (eg, Crohn disease, cancer, and trauma) exists and the relationship to AEF formation is investigated in this review. Likewise, we examine the abundant data in the surgical literature on burn and thermal injury progression as well as the acute and chronic mitigating effects of cooling. We discuss the relationship of these data and maladaptive healing mechanisms to the well-recognized postablation pathophysiological effects after RF ablation. Finally, we review additional important considerations such as patient selection, clinical workflow, and implementation strategies for proactive esophageal cooling.

Step-by-step recommendations utilizing four-dimensional intracardiac echocardiography in left atrial appendage procedures.

INTRODUCTION: Four-dimensional (4D) intracardiac echocardiography (ICE) is a novel cardiac imaging modality that has been applied to various workflows, including catheter ablation, tricuspid valve repair, and left atrial appendage occlusion (LAAO). The use of this type of advanced ICE imaging may ultimately allow for the replacement of transesophageal echocardiography (TEE) for LAAO, providing comparable imaging quality while eliminating the need for general anesthesia. METHODS: Based on our initial clinical experience with 4D ICE in LAAO, we have developed an optimized workflow for the use of the NUVISION™ 4D ICE Catheter in conjunction with the GE E95 and S70N Ultrasound Systems in LAAO. In this manuscript, we provide a step-by-step guide to using 4D ICE in conjunction with compatible imaging consoles. We have also evaluated the performance of 4D ICE with the NUVISION Ultrasound Catheter versus TEE in one LAAO case and present those results here. RESULTS: In our comparison of 4D ICE using our optimized workflow with TEE in an LAAO case, ICE LAA measurements were similar to those from TEE. The best image resolution was seen via ICE in 2-dimensional and multislice modes (triplane and biplane). The FlexiSlice multiplanar reconstruction tool, which creates an en-face image derived from a 4D volume set, also provided valuable information but yielded slightly lower image quality, as expected for these volume-derived images. For this case, comparable images were obtained with TEE and ICE but with less need to reposition the ICE catheter. CONCLUSION: The use of optimized 4D ICE catheter workflow recommendations allows for efficient LAAO procedures, with higher resolution imaging, comparable to TEE.

Impact of an Organized Treatment Pathway on Management of Atrial Fibrillation: The ER2EP Study.

Background: Atrial fibrillation (AF) is the most common arrhythmia reported worldwide. There is significant heterogeneity in AF care pathways for a patient seen in the emergency room, impacting access to guideline-driven therapies. Objectives: The purpose of this study was to compare the difference in AF outcomes between those treated with an organized treatment pathway vs routine-care approach. Methods: The emergency room to electrophysiology service study (ER2EP) is a multicenter, prospective observational registry (NCT04476524) enrolling patients with AF from sites where a pathway for management of AF was put in place compared to sites where a pathway was not in place within the same health system and the same physicians providing services at all sites. Multivariable regression modeling was performed to identify predictors of clinical outcomes. Beta coefficient or odds ratio was reported as appropriate. Results: A total of 500 patients (ER2EP group, n = 250; control group, n = 250) were included in the study. The mean age was 73.4 ± 12.9 years, and 52.2% were males. There was a statistically significant difference in primary endpoint [time to ablation (56 ± 50.9 days vs 183.3 ± 109.5 days; P < 0.001), time to anticoagulation initiation (2.1 ± 1.6 days vs 19.7 ± 35 days, P < 0.001), antiarrhythmic drug initiation (4.8 ± 7.1 days vs 24.7 ± 44.4 days, P < 0.001) compared to the control group, respectively. As such, this resulted in reduced length of stay in the ER2EP group compared to the control group (2.4 ± 1.4 days vs 3.23 ± 2.5 days, P = 0.002). Conclusions: This study provides evidence that having an organized pathway from the emergency department for AF patients involving electrophysiology services can improve early access to definitive therapies and clinical outcomes.

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.

Bilateral Cardiac Sympathetic Denervation for Refractory Multifocal Premature Ventricular Contractions in Patients With Nonischemic Cardiomyopathy.

BACKGROUND: Bilateral cardiac sympathetic denervation (BCSD) for refractory life-threatening ventricular arrhythmias is a neuromodulatory intervention targeting sympathetically driven focal or re-entrant ventricular arrhythmias. OBJECTIVES: This study sought to provide a more complete and successful option for intervention in patients in whom premature ventricular contraction (PVC) ablation is not feasible or has been unsuccessful. METHODS: A total of 43 patients with >5% PVC burden and concomitant nonischemic cardiomyopathy (NICM) who previously failed medical and ablation therapies were referred for BCSD. All patients underwent bilateral video-assisted thoracoscopic surgical approach with T1-T4 sympathectomy. Primary effectiveness endpoints were postprocedural PVC burden resolution, improvement in left ventricular ejection fraction (LVEF), and cessation of antiarrhythmic drugs (AADs). Safety endpoints included peri- and postprocedural complications. Outcomes were assessed over a 1-year follow-up period. RESULTS: Among the 43 patients who underwent BCSD, the mean age was 52.3 ± 14.7 years, 69.8% of whom were male patients. Presenting mean LVEF was 38.7% ± 7.8%, and PVC burden was 23.7% ± 9.9%. There were significant reductions in PVC burden postprocedurally (1.3% ± 1.1% post-BCSD, compared with 23.7% ± 9.9% pre-BCSD, P < 0.001) and improvements in LVEF (46.3% ± 9.5% post-BCSD, compared with 38.7% ± 7.8% pre-BCSD, P < 0.001). The rate of ICD therapies decreased from 81.4% (n = 35) to 11.6% (n = 5) (P < 0.001), leading to a significant reduction in use of AADs (100.0% to 11.6%, P < 0.001) and improvement in mean NYHA functional class (2.5 ± 0.5 to 1.4 ± 0.2, P < 0.001). Major intraoperative complications were seen in 4.7% of patients (hemothorax and chylothorax). Of the patients, 81.4% (n = 35) experienced no mortality or major complications over a 1-year follow-up period, with the remaining still within their first year postprocedure. CONCLUSIONS: BCSD is effective for the management of refractory PVCs and ventricular tachycardia who have failed previous ablation therapy.

The missing vector - TactiFlex sensor enabled ablation catheter.

New ablation catheters have continuously developed to improve the safety and efficacy of ablation procedures. The TactiFlex Ablation Catheter Sensor Enabled (Abbott, Minneapolis, MN) is a novel open-irrigation radiofrequency ablation catheter that has contact force-sensing technology and flexible tip, allowing real-time contact force assessment with directionality. This case report reported a loss of contact force vector and directionality with the TactiFlex SE ablation catheter during de novo atrial fibrillation (AF) ablation.

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.

Arrhythmogenic Cardiomyopathy: Evolving Diagnostic Criteria and Insight from Cardiac Magnetic Resonance Imaging.

Arrhythmogenic cardiomyopathy (ACM) is an umbrella term encompassing a wide variety of overlapping hereditary and nonhereditary disorders that can result in malignant ventricular arrhythmias and sudden cardiac death. Cardiac MRI plays a critical role in accurate diagnosis of various ACM entities and is increasingly showing promise in risk stratification that can further guide management particularly in decisions regarding use of implantable cardioverter defibrillator. Genotyping plays an important role in cascade testing but challenges remain due to incomplete penetrance and wide phenotypic variability of ACM as well as the presence of gene-elusive cases.

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.

Lower-adherence direct oral anticoagulant use is associated with increased risk of thromboembolic events than warfarin.

BACKGROUND: Real-world data have suggested inconsistent adherence to oral anticoagulation for thromboembolic event (TE) prevention in patients with Non valvular atrial fibrillation (NVAF), yet it remains unclear if event risk is elevated during gaps of non-adherence. OBJECTIVE: To compare difference in outcomes between direct oral anticoagulant (DOAC) and warfarin based on adherence to the therapy in patients with NVAF. METHODS: Using the MarketScan claims data, patients receiving prescription of warfarin or a DOAC for NVAF from January 2015 to June 2016 were included. Outcomes included hospitalization for TE (ischemic stroke or systemic embolism), hemorrhagic stroke, stroke of any kind, and major bleeding. Event rates were reported for warfarin and DOACs at a higher-adherence proportion of days covered (PDC > 80%) and lower-adherence (PDC 40-80%). RESULTS: The cohort included 83,168 patients prescribed warfarin (51% [n = 42,639]) or DOAC (49% [n = 40,529]). Lower adherence occurred in 36% (n = 15,330) of patients prescribed warfarin and 26% (n = 10,956) prescribed DOAC. As compared to higher-adherence warfarin after multivariable adjustment, the risk of TE was highest in lower-adherence DOAC (HR 1.26; 95% CI, 1.14-1.33), and lowest in higher-adherence DOAC (HR, 0.93; 95% CI, 0.88-0.99). There was a significantly higher risk of hemorrhagic stroke and stroke of any kind in the lower-adherence groups. Major bleeding was more common with lower-adherence DOAC (HR, 1.43, 95% CI, 1.35-1.52) and lower-adherence warfarin (HR, 1.32, 95% CI, 1.26-1.39). CONCLUSIONS: In this large real-world study, low adherence DOAC was associated with higher risk of TE events as compared to high and low adherence warfarin.

Quelling the Storm: A Review of the Management of Electrical Storm.

Heightened sympathetic input to the myocardium potentiates cardiac electrical instability and may herald an electrical storm. An electrical storm is characterized by 3 or more episodes of ventricular tachycardia, ventricular fibrillation, or appropriate internal cardiac defibrillator shocks within 24 hours. Management of electrical storms is resource-intensive and inevitably requires careful coordination between multiple subspecialties. Anesthesiologists have an important role in acute, subacute, and long-term management. Identifying the phase of an electrical storm and understanding the characteristics of each morphology may help the anesthesiologist anticipate the management approach. In the acute phase, management of an electrical storm is aimed at providing advanced cardiac life support and identifying reversible causes. After initial stabilization, subacute management focuses on dampening the sympathetic surge with sedation, thoracic epidural, or stellate ganglion blockade. Definitive long-term management with surgical sympathectomy or catheter ablation also may be warranted. Our objective is to provide an overview of electrical storms and the anesthesiologist's role in management.

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.

Feasibility and Safety of Intravenous Sotalol Loading in Adult Patients With Atrial Fibrillation (DASH-AF).

BACKGROUND: Inpatient initiation of sotalol is recommended owing to its proarrhythmic effects. OBJECTIVES: The DASH-AF (Feasibility and Safety of Intravenous Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy in Adult Patients With Atrial Fibrillation) trial evaluates the safety and feasibility of intravenous (IV) sotalol, achieving a steady state with maximum QTc prolongation within 6 hours instead of the traditional 5-dose inpatient oral (PO) titration. METHODS: DASH-AF is a prospective, nonrandomized, multicenter, open-label trial consisting of patients who underwent IV sotalol loading dose to initiate rapid oral therapy for atrial arrhythmias. IV dose was calculated based on the target oral dose as indicated by baseline QTc and renal function. Patients' QTc (in sinus) was measured via electrocardiography at 15-minute intervals and after IV loading completion. Patients were discharged 4 hours after first oral dose. All patients were monitored via mobile cardiac outpatient telemetry for 72 hours. The control group was composed of patients admitted for the traditional 5 PO doses. Safety outcomes were assessed in both groups. RESULTS: A total of 120 patients from 3 centers were enrolled from 2021 to 2022 in the IV loading group (compared with type of AF- and renal function-matched patients in the conventional PO loading cohort). This study demonstrated no significant change in ΔQTc in both groups, with a significantly lower number of patients requiring dose adjustment in the IV arm compared with the PO arm (4.1% vs 16.6%; P = 0.003). This led to potential cost savings of up to $3,500.68 per admission. CONCLUSIONS: The DASH-AF trial shows that rapid IV sotalol loading in atrial fibrillation/flutter patients for rhythm control is feasible and safe compared with conventional oral loading with significant cost reduction. (Feasibility and Safety of Intravenous Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy in Adult Patients With Atrial Fibrillation [DASH-AF]; NCT04473807).