Contemporary Management of Cardiac Implantable Electronic Device Infection: The American College of Cardiology COGNITO Survey.

Background: Cardiac implantable electronic devices (CIEDs) infection remains a serious complication, causing increased morbidity and mortality. Early recognition and escalation to definitive therapy including extraction of the infected device often pose challenges. Objectives: The purpose of this study was to assess U.S.-based physicians current practices in diagnosing and managing CIED infections and explore potential extraction barriers. Methods: An observational survey was performed by the American College of Cardiology including U.S. physicians managing CIEDs from February to March 2022. Sampling techniques and screener questions determined eligibility. The survey featured questions on knowledge and experience with CIED infection patients and case scenarios. Results: Of 387 physicians completing the survey (20% response rate), 49% indicated familiarity with current guidelines regarding CIED infection. Electrophysiologists (EPs) (91%) were more familiar with these guidelines, compared to non-EP cardiologists (29%) and primary care physicians (23%). Only 30% of physicians specified that their institution had guideline-based protocols in place for managing patients with CIED infection. When presented with pocket infection cases, approximately 89% of EPs and 50% of non-EP cardiologists would follow guideline recommendation to do complete CIED system removal, while 70% of primary care physicians did not recommend guideline-directed treatment. Conclusions: There are gaps in familiarity of guidelines as well as the knowledge in practical management of CIED infection with non-extracting physicians. Most institutions lack a definite pathway. Addressing discrepancies, including guideline education and streamlining care or referral pathways, will be a key factor to bridging the gap and improving CIED infection patient outcomes.

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.

Evaluation of organized atrial arrhythmias after cryptogenic stroke.

Background: Long-term rhythm monitoring to detect atrial fibrillation (AF) following a cryptogenic stroke (CS) is well established. However, the burden of organized atrial arrhythmias in this population is not well defined. Objective: The purpose of this study was to assess the incidence and risk factors for organized atrial arrhythmias in patients with CS. Methods: We evaluated all patients with CS who received an insertable cardiac monitor (ICM) between October 2014 and April 2020. All ICM transmissions categorized as AF, tachycardia, or bradycardia were reviewed. We evaluated the time to detection of organized AF and the combination of either organized atrial arrhythmia or AF. Results: A total of 195 CS patients with ICMs were included (51% men; mean age 66 ± 12 years; mean CHA2DS2-VASC score 4.6). Over mean follow-up of 18.9 ± 11.2 months, organized atrial arrhythmias lasting ≥30 seconds were detected in 45 patients (23%), of whom 62% did not have AF. Seventeen patients had both organized atrial arrhythmia and AF, and another 21 patients had AF only. Compared to those with normal left atrial size, patients with left atrial enlargement had a higher adjusted risk for development of atrial arrhythmias (mild left atrial enlargement: hazard ratio 1.99; 95% confidence interval 1.06-3.75; moderate/severe left atrial enlargement: hazard ratio 3.06; 95% confidence interval 1.58-5.92). Conclusion: Organized atrial arrhythmias lasting ≥30 seconds are detected in nearly one-fourth of CS patients. Two-thirds of these patients did not have AF. Further studies are required to evaluate the impact of organized atrial arrhythmias on recurrent stroke risk.

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.

Frailty and associated outcomes in patients undergoing percutaneous left atrial appendage occlusion: findings from the NCDR LAAO registry.

BACKGROUND: Frailty is associated with significant morbidity and mortality and may have clinical implications in an advanced age population with atrial fibrillation undergoing left atrial appendage occlusion (LAAO). We sought to develop a novel frailty scale to predict worse outcomes in patients undergoing LAAO. METHODS: Patients in the NCDR LAAO Registry between 2016 and 2021 receiving percutaneous LAAO devices were categorized as non-frail (0 points), pre-frail (1-3 points), or frail (4-5 points) based on a 5-point scale representing multiple domains of frailty: hemoglobin <13.0 g/dL in male, <12.0 g/dL in female; creatinine ≥1.2 mg/dL; albumin <3.5 g/dL; body mass index <20 kg/m2; and increased risk of falls. RESULTS: Of 57,728 patients, 44,360 (76.8%) were pre-frail and 7693 (13.3%) were frail. Compared to non-frail, pre-frail and frail patients were older, had a higher burden of co-morbidities, and more disability based on the Modified Rankin Scale. Compared to non-frail patients after adjustment, frail patients were at higher risk of in-hospital major complication (OR 1.29, 95% 1.02-1.62, p = 0.01), any complication (OR 1.29, 95% CI 1.09-1.52, p = 0.0005), and death (OR 5.79, 95% CI 1.75-19.17, p = 0.001), while no difference was observed in pre-frail patients. At 45-day follow-up, there was no difference in the risk of complications in frail patients as compared to non-frail, although mortality was significantly higher (OR 3.01, 95% CI 1.97-4.85, p < 0.0001). CONCLUSION: A simple and practical frailty scale accurately predicts adverse events in patients undergoing LAAO. The 13% of patients considered frail were at significantly higher risk of in-hospital adverse events and 45-day mortality.

Catheter ablation using pulmonary vein isolation with versus without left atrial posterior wall isolation for persistent atrial fibrillation: an updated systematic review and meta-analysis.

BACKGROUND: Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation of atrial fibrillation (AF); however, the results are suboptimal for persistent AF. The left atrial posterior wall (LAPW) is thought to be a major additional area in initiation and perpetuation of persistent AF. Therefore, adjunctive ablation of the posterior wall may reduce AF recurrence in patients with persistent AF. OBJECTIVE: The objective of this study was to compare outcomes of catheter ablation in patients with persistent AF using PVI alone versus a combination of PVI and LAPW isolation. METHODS: Literature search was conducted in PubMed, PubMed Central, Scopus, and Embase since inception to February 2023. Screening of studies was done via Covidence software. Risk of bias assessment was done using appropriate tools. Data extraction and a narrative synthesis were carried out accordingly. RESULTS: Ten studies were included, of which five were randomized controlled trials. PVI with LAPW ablation group had significantly lower recurrence of overall atrial tachyarrhythmia (OR 0.47, CI 0.32-0.70) and AF (OR 0.39, CI 0.23-0.69). In sensitivity analysis, freedom from atrial arrhythmias was noted to be significantly higher in the PVI with LAPW ablation group (OR 2.22, CI 1.36-3.64). However, there was no significant difference in occurrence of atrial flutter (OR 1.36, CI 0.86-2.14) or with periprocedural adverse events (OR 1.10, CI 0.60-1.99). CONCLUSION: LAPW ablation, in addition to PVI, significantly improves the rates of arrhythmia freedom and reduces the recurrence of overall atrial tachyarrhythmia. There was no significant difference in atrial flutter or periprocedural adverse events.

Left Atrial Appendage Closure with Watchman vs Amulet Devices: Similarities and Differences.

PURPOSE OF REVIEW: Left atrial appendage closure (LAAC) has shown to be non-inferior to oral anticoagulation (OAC) for non-valvular atrial fibrillation (AF). LAAC is now becoming a leading method for stroke prophylaxis in patients who have atrial fibrillation and are unable to tolerate OAC. There are currently two FDA-approved endocardial closure devices, namely, the Watchman FLX and Amplatzer Amulet. RECENT FINDINGS: Current data highlights that both devices offer similar efficacy and safety for LAAC. While the two devices differ in terms of intraprocedural complication rates, they offer similar short- to long-term outcomes in regard to peri-device leaks, device-related thrombosis, and mortality. With similar risk and safety profiles, both devices are indicated for patients who are unable to tolerate OAC. Newer clinical studies are directed to establish the efficacy of both devices as the primary method for stroke prevention in AF as an alternate to OAC.

Long-Term Imaging and Clinical Outcomes of Surgical Left Atrial Appendage Occlusion With AtriClip.

Surgical left atrial appendage (LAA) occlusion with an AtriClip (AtriCure, West Chester, Ohio) is frequently performed for stroke prophylaxis in patients with atrial fibrillation (AF). We conducted a retrospective analysis of all patients with long-standing persistent AF who underwent hybrid convergent ablation and LAA clipping. Contrast-enhanced cardiac computed tomography was performed at 3 to 6 months after LAA clipping to assess the degree of complete closure and the residual LAA stump. A total of 78 patients (64 ± 10 years, 72% male) underwent LAA clipping as part of hybrid convergent AF ablation, from 2019 to 2020. Median size of AtriClip used was 45 mm. Mean LA size was 4.6 ± 1 cm. At 3-to-6 months follow-up computed tomography, 46.2% of patients (n = 36) had a residual stump proximal to the deployed LAA clip. Mean depth of residual stump was 3.95 ± 5.5 mm, with 19% of patients (n = 15) having a stump depth of ≥10 mm and 1 patient requiring more endocardial LAA closure owing to large stump depth. During 1-year follow-up, 3 patients developed stroke; device leak of 6 mm was noted in 1 patient; and none of the patients had a thrombus proximal to the clip. In conclusion, high incidence of residual LAA stump was observed with AtriClip. Larger studies with long-term follow-up are needed to better assess the thromboembolic implications of a residual stump after AtriClip placement.

Data deluge from remote monitoring of cardiac implantable electronic devices and importance of clinical stratification.

Background: Remote monitoring (RM) has been accepted as a standard of care for follow-up of patients with cardiac implantable electronic devices (CIEDs). However, the resulting data deluge poses major challenge to device clinics. Objective: This study aimed to quantify the data deluge from CIED and stratify these data based on clinical relevance. Methods: The study included patients from 67 device clinics across the United States being remotely monitored by Octagos Health. The CIEDs included implantable loop recorders, pacemakers, implantable cardioverter-defibrillators, cardiac resynchronization therapy defibrillators, and cardiac resynchronization therapy pacemakers. Transmissions were either dismissed before reaching the clinical practice if they were repetitive or redundant or were forwarded if they were either clinically relevant or actionable transmission (alert). The alerts were further classified as level 1, 2, or 3 based on clinical urgency. Results: A total of 32,721 patients with CIEDs were included. There were 14,465 (44.2%) patients with pacemakers, 8381 (25.6%) with implantable loop recorders, 5351 (16.4%) with implantable cardioverter-defibrillators, 3531 (10.8%) with cardiac resynchronization therapy defibrillators, and 993 (3%) with cardiac resynchronization therapy pacemakers. Over a period of 2 years of RM, 384,796 transmissions were received. Of these, 220,049 (57%) transmissions were dismissed, as they were either redundant or repetitive. Only 164,747 (43%) transmissions were transmitted to the clinicians, of which only 13% (n = 50,440) had clinical alerts, while 30.6% (n = 114,307) were routine transmissions. Conclusion: Our study shows that data deluge from RM of CIEDs can be streamlined by utilization of appropriate screening strategies that will enhance efficiency of device clinics and provide better patient care.

Anatomical location of leadless pacemaker and the risk of pacing-induced cardiomyopathy.

BACKGROUND: It is unclear if the location of implantation of the leadless pacemaker (LP) makes a difference in the incidence of pacing-induced cardiomyopathy (PICM). AIM: The aim of this study was to compare the incidence of PICM based on the location of implantation of LP. METHODS: A total of 358 consecutive patients [women: 171 (48%), mean age: 73 ± 15 years] with left ventricular ejection fraction (EF) > 50%, who received an LP (Micra) between January 2017 and June 2022, formed the study cohort. Micra-AV and Micra-VR were implanted in 122 (34%) and 236 (66%) patients, respectively. Fluoroscopically, the location of implantation of LP in the interventricular septum (IS) was divided into two equal halves (apex/apical septum [AS] and mid/high septum [HS]). During follow-up, PICM was defined as an EF drop of ≥10%. RESULTS: LP was implanted in 109 (34%) and 249 (66%) patients at AS and HS locations, respectively. During a mean 18 ± 8 months follow-up, 28 patients (7.8%) developed PICM. Among the 249 patients with HS placement of LP, 10 (4%) developed PICM, whereas among the 109 patients with AS placement of LP, 18 (16.5%) developed PICM (p = .002). AS location was associated with a higher risk of PICM compared to HS locations (adjusted hazard ratio: 4.42, p < .001). CONCLUSION: AS location of LP was associated with a higher risk of PICM compared to HS placement. Larger randomized studies are needed to confirm our findings.

In-hospital complications associated with pulmonary vein isolation with adjunctive lesions: the NCDR AFib Ablation Registry.

AIMS: No prior study has been adequately powered to evaluate real-world safety outcomes in those receiving adjunctive ablation lesions beyond pulmonary vein isolation (PVI). We sought to evaluate characteristics and in-hospital complications among patients undergoing PVI with and without adjunctive lesions. METHODS AND RESULTS: Patients in the National Cardiovascular Data Registry AFib Ablation Registry undergoing first-time atrial fibrillation (AF) ablation between 2016 and 2020 were identified and stratified into paroxysmal (PAF) and persistent AF, and separated into PVI only, PVI + cavotricuspid isthmus (CTI) ablation, and PVI + adjunctive (superior vena cava isolation, coronary sinus, vein of Marshall, atypical atrial flutter lines, other). Adjusted odds of adverse events were calculated using multivariable logistic regression. A total of 50 937 patients [PAF: 30 551 (60%), persistent AF: 20 386 (40%)] were included. Among those with PAF, there were no differences in the adjusted odds of complications between PVI + CTI or PVI + adjunctive when compared with PVI only. Among persistent AF, PVI + adjunctive was associated with a higher risk of any complication [3.0 vs. 4.5%, odds ratio (OR) 1.30, 95% confidence interval (CI) 1.07-1.58] and major complication (0.8 vs. 1.4%, OR 1.56, 95% CI 1.10-2.21), while no differences were observed in PVI + CTI compared with PVI only. Overall, there was high heterogeneity in adjunctive lesion type, and those receiving adjunctive lesions had a higher comorbidity burden. CONCLUSION: Additional CTI ablation was common without an increased risk of complications. Adjunctive lesions other than CTI are commonly performed in those with more comorbidities and were associated with an increased risk of complications in persistent AF, although the current analysis is limited by high heterogeneity in adjunctive lesion set type.

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).

Comparative assessment of safety with leadless pacemakers compared to transvenous pacemakers: a systemic review and meta-analysis.

BACKGROUND: Leadless pacemakers (LP) and transvenous pacemakers (TVP) are two stable pacing platforms currently available in clinical practice. Observational data show mixed results with regards to their comparative safety. This meta-analysis was aimed to evaluate the comparative safety of LP over TVP. METHODS: The study protocol was registered in PROSPERO registry (CRD42022325376). Six databases were searched for published literature from inception to April 12, 2022. RevMan 5.4.1 was used for statistical analysis. Odds ratio (OR) and mean difference were used to estimate the outcome with a 95% confidence interval (CI). RESULTS: A total of 879 studies were imported from the databases. Among these, 41 papers were screened for full text and 17 meet the inclusion criteria. Among them, pooled results showed 42% lower odds of occurrence of complications in the LP group (OR 0.58, CI 0.42-0.80) compared to TVP group. Notably, 70% lower odds of device dislodgment (OR 0.30, CI 0.21-0.43), 46% lower odds of re-intervention (OR 0.54, CI 0.45-0.64), 87% lower odds of pneumothorax (OR 0.13, CI 0.03-0.57), albeit, 2.65 times higher odds of pericardial effusion (OR 2.65, CI 1.49-4.70) were observed in the LP group. CONCLUSIONS: This meta-analysis showed LP to be a significantly safer modality compared to TVP, in terms of re-intervention, device dislodgment, pneumothoraxes, and overall complications. However, there were higher rates of pericardial effusion in the LP group. There was a diverse number of patients included, and all studies were observational. Randomized trials are needed to validate our findings.