Safety of Amulet Left Atrial Appendage Occluder and Watchman Device for Left Atrial Appendage Closure in Patients With Atrial Fibrillation.

BACKGROUND: Left atrial appendage (LAA) closure is an alternative to chronic anticoagulation for stroke prevention in patients with nonvalvular atrial fibrillation. Multiple devices were used for LAA closure, with the Amplatzer Amulet LAA Occluder (Abbott, Chicago, IL, USA) and Watchman device (Boston Scientific, Marlborough, MA, USA) being the most commonly used in clinical practice. In August 2021, the FDA approved the use of the Amplatzer Amulet LAA Occluder. There is still a knowledge gap in the safety profile of the Amplatzer Amulet LAA Occluder device in comparison to the Watchman device. OBJECTIVE: The aim of this study was to assess and compare the safety profile peri-procedure and post-procedure between the Amplatzer Amulet LAA Occluder and Watchman devices. METHODS: Patients who underwent LAA closure using Watchman or Amulet devices from July 2015 to August 2020 at the American University of Beirut Medical Center were included in the analysis. Primary endpoints included peri-operative and post-procedural complications (thromboembolic events, bleeding complications, vascular access complications, pericardial effusion/tamponade, device positional complications and in-hospital death). RESULTS: The study included 37 patients (21 had Watchman devices, 16 had Amplatzer Amulet LAA Occluder devices, and 28 were men, mean age 76.57 ± 9.3 years). Seven patients developed post-procedural iatrogenic atrial septal defects (four in the Watchman group vs three in the Amulet group, p-value=0.982). Three patients developed pericardial effusion (one in the Watchman vs two in the Amulet group, p-value=0.394). Only one patient developed peri-device leak (one in the Watchman group vs none in the Amulet group, p-value=0.283). One device could not be deployed (one in the Amulet group vs none in the Watchman group, p-value=0.191). None of the patients developed in-hospital death, cardiac tamponade, device embolism, device thrombosis, stroke/transient ischemic attack (TIA), cranial bleeding, or arrhythmias after the procedure. The rate of peri-operative complications was similar between both groups. Both groups displayed low rates of adverse events in the peri-operative and post-operative periods. CONCLUSION: There was no significant difference in the safety profile of Amplatzer Amulet LAA Occluders and Watchman devices. There was a low incidence of peri-operative and post-operative adverse events with the implanted devices.

Establishing Safe Working Parameters for Radiofrequency Ablation In Vitro Using Acoustic Sensing, Probability Mapping, and Catheter Contact Angle.

Surgical quality and safety in radiofrequency catheter ablation (RFA) are critical in arrhythmia procedures. Steam pops, in particular, are potentially catastrophic events that must be avoided; otherwise, they may cause significant damage to the myocardium. This study aimed to evaluate the effect of applied RFA inclination angle and tissue contact parameters on the ablated volume and "steam pop" formation. An ex vivo model consisting of a viable ovine myocardium, an ablation catheter, and a circulating warmed 0.9% NaCl saline solution was used. RFA was conducted while controlling for contact force, electrical power, ablation time, flow rate, irrigation, and catheter tip angle. Irrigation was delivered to the catheter tip manually when indicated. Acoustic transducers were included in the setup to detect preliminary acoustic signals. A total dataset of 567 measurements was taken. Benign precursory signals (hissing and lower-intensity "pops") were detected by acoustic sensors preceding the occurrence of "steam pops." Furthermore, a Pearson coefficient of r = 0.809 with P < .01 was shown to exist between the acoustic intensity of a "steam pop" and the ablated lesion volume. RFA powers of 25 and 30 W with a duration of 20 s induced more "steam pops" than ablation powers of ≤20 W with a duration of ≥30 s. There was also an increased probability of "steam pop" formation with the use of a non-irrigated catheter tip, as compared to an irrigated catheter tip. A more acute catheter angle increased the lesion size at powers of 20 and 25 W (r = -0.568 and r = -0.653, both P < .05, respectively). There is a potential benefit of using acoustic sensing as a warning before the occurrence of "steam pops." Varying power, duration, and catheter tip angle will generate different ablation sizes and need to be tailored to individual needs and procedures.

Safety of mapping in the sinus of valsalva region under intracardiac echocardiography guidance without angiography.

BACKGROUND: Radiofrequency ablation at the region of the sinus of Valsalva carries a risk to the ostia of the coronary arteries. Coronary angiography is usually utilized to document a safe distance for mapping and ablation. OBJECTIVE: To show that catheter ablation in the aortic root could be guided by phased-array intra cardiac echocardiography (ICE) and electro anatomic mapping without the need for coronary angiography. METHODS: We reviewed all patients referred to our lab that underwent mapping and/or ablation in the sinus of Valsalva region. Procedures were carried out by operators that are skilled in the use of ICE. The need for angiography was documented, also the rate of success along with the immediate and 30-day complications rate. RESULTS: Seventy patients (average age 48.7 ± 13.8 years; 64.3% males) were referred for ablation of ventricular and atrial arrhythmias. PVC constituted 95.7% of the cases. All patients underwent mapping and/or ablation at the sinus of Valsalva region without the need for coronary angiography to visualize the coronary ostia. Acute and effective ablation was achieved in 57 out of 70 (81.4%) patients partially effective ablation was achieved in 10 (14.3%) patients, and failure to ablate in the remaining 3 patients (4.3%). There was no occurrence of any adverse events, neither immediately or at day 30 after the procedure. CONCLUSION: In the hands of experienced operators, mapping and radiofrequency ablation in the sinus of Valsalva can be safely and reliably performed using intracardiac echocardiography alone without the need for supplementary catheter coronary angiography.

Genomic and Proteomic Study of the Inflammatory Pathway in Patients With Atrial Fibrillation and Cardiometabolic Syndrome.

Atrial fibrillation (AF) and cardiometabolic syndrome (CMS) have been linked to inflammation and fibrosis. However, it is still unknown which inflammatory cytokines contribute to the pathogenesis of AF. Furthermore, cardiometabolic syndrome (CMS) risk factors such as obesity, hypertension, insulin resistance/glucose intolerance are also associated with inflammation and increased level of cytokines and adipokines. We hypothesized that the inflammatory immune response is exacerbated in patients with both AF and CMS compared to either AF or CMS alone. We investigated inflammatory cytokines and fibrotic markers as well as cytokine genetic profiles in patients with lone AF and CMS. CMS, lone AF patients, patients with both lone AF and CMS, and control patients were recruited. Genetic polymorphisms in inflammatory and fibrotic markers were assessed. Serum levels of connective tissue growth factor (CTGF) were tested along with other inflammatory markers including platelet-to-lymphocyte ratio (PLR), monocyte-to-HDL ratio (MHR) in three groups of AF+CMS, AF, and CMS patients. There was a trend in the CTGF levels for statistical significance between the AF and AF+CMS group (P = 0.084). Genotyping showed high percentages of patients in all groups with high secretor genotypes of Interleukin-6 (IL-6) (P = 0.037). Genotyping of IFN-γ and IL-10 at high level showed an increase in expression in the AF + CMS group compared to AF and CMS alone suggesting an imbalance between the inflammatory and anti-inflammatory cytokines which is exacerbated by AF. Serum cytokine inflammatory cytokine levels showed that IL-4, IL-5, IL-10, IL-17F, and IL-22 were significant between the AF, AF+CMS, and CMS patients. Combination of both CMS and AF may be associated with a higher degree of inflammation than what is seen in either CMS or AF alone. Thus, the identification of a biomarker capable of identifying metabolic syndrome associated with disease will help in identification of a therapeutic target in treating this devastating disease.

Potentially inappropriate medications in elderly patients with heart failure: Beers Criteria-based study.

OBJECTIVES: Primary objectives were to evaluate the use of potentially inappropriate medication (PIM) use in elderly heart failure (HF) patients and the factors associated with the number of PIMs. Secondary objectives were to test for the correlation between PIMs and quality of life (QOL) and depression. METHODS: A cross-sectional study was conducted among 125 elderly Lebanese HF patients with left ventricular ejection fraction <50%. Data on socio-demographics, clinical data and medications were collected. Patients were interviewed with Minnesota living with Heart Failure Questionnaire (MLHFQ) and Patient Health Questionnaire-9 (PHQ-9). Medication profile per patient was evaluated for PIMs using Beers Criteria. The correlations between the number of PIMs and the MLHFQ, PHQ-9 and the number of medications were tested using Pearson's correlation. Linear regression was done to predict the factors associated with the number of PIMs. KEY FINDINGS: Patients were taking a total of 1035 medications with a mean of 8.28 ± 3.14 medications. In total, 80.0% of patients were taking at least one PIM. Diuretics (55.2%) and proton pump inhibitors (41.6%) were most commonly prescribed PIMs. The number of PIMs was moderately correlated with the number of medications and the MLHFQ score. Linear regression showed that the number of medications, age ≥85 years, chronic kidney disease and HF with New York Heart Association III were associated with more PIMs. CONCLUSIONS: A high percentage of PIMs was found among a sample of elderly Lebanese HF patients. HF multidisciplinary team is needed to control the prescription of PIMs in this vulnerable population.

The atrial FibriLlatiOn real World management registry in the Middle East and Africa: design and rationale.

BACKGROUND: Atrial fibrillation is the most common cardiac arrhythmia, affecting 33.5 million patients globally. It is associated with increased morbidity, leading to significant clinical and economic burden. There exist only limited data in the Middle Eastern region from the existing registries. The goal of the FLOW-AF (atrial FibriLlatiOn real World management registry in the Middle East and Africa) registry is to evaluate the characteristics, treatment patterns, and clinical and economic outcomes associated with anticoagulation among patients newly diagnosed with nonvalvular atrial fibrillation in Egypt, Lebanon, the Kingdom of Saudi Arabia, and the United Arab Emirates. METHODS: This study will be a multicountry, multicenter, prospective observational registry aiming to enroll 1446 newly diagnosed nonvalvular atrial fibrillation patients at more than 20 sites across the four countries. During the recruitment period, patients will be included if they were newly diagnosed with nonvalvular atrial fibrillation and had initiated treatment for the prevention of stroke/systemic embolism. Patient data will be assessed prospectively at 6 and 12 months from their enrollment date. Demographics, clinical characteristics, antithrombotic treatments received, clinical outcomes, adverse events, healthcare resource utilization, and direct costs associated with management of nonvalvular atrial fibrillation will be collected and analyzed overall, by country, and by groups created based on treatment, demographics, and clinical characteristics, medical history and risk factors. CONCLUSION: The FLOW-AF registry will provide information on the uptake of oral anticoagulants, treatment patterns, clinical outcomes, and healthcare utilization and costs among newly diagnosed nonvalvular atrial fibrillation patients in the Middle Eastern region.

Self-care confidence mediates self-care maintenance and management in patients with heart failure.

BACKGROUND: Literature highlights the influence of self-care confidence on self-care in patients with heart failure (HF), but little is known whether it explains the influence of other determinants of self-care. OBJECTIVES: To examine whether confidence explained the associations of social support and HF-knowledge with self-care. METHODS: In a descriptive, correlational study, 100 patients with HF completed questionnaires on self-care, social support, and HF-specific knowledge. Regression analyses were used to examine associations between perceived support and HF-knowledge and self-care. RESULTS: Self-care confidence mediated the association between social support and self-care maintenance (path reduced from Beta = 0.713 to 0.395) and HF-knowledge and maintenance (path reduced from Beta = 2.569 to 1.798) and management (path reduced from Beta = -0.272 to -0.144). CONCLUSION: Self-care confidence explains the influence of social support and knowledge on self-care. Supporting self-care confidence may be a key target for interventions to improve disease management and behaviors in patients with HF.

Cardiac implantable electronic device infections: Observational data from a tertiary care center in Lebanon.

With increasing rates of device implantation, there is an increased recognition of device infection. We conducted a retrospective observational study in a tertiary care center in Lebanon, with data collected from medical records of patients presenting with cardiac implantable electronic device (CIED) infection from 2000 to 2017 with the purpose of identifying etiologies, risk factors and other parameters, and comparing them to available data from the rest of the world. We identified a total of 22 CIED infections. The most common microbial etiologies, including involvement in polymicrobial infection, were coagulase-negative staphylococci (45.5%) and Staphylococcus aureus (22.7%). Rare cases of Brucella melitensis, Sphingomonas paucimobilis, and Kytococcus schroeteri device infection were seen. Heart failure was seen in 77.3% of patients, hypertension in 68.2%, and chronic kidney disease in 50%. Skin changes were the most common presenting symptoms (86.4%). Antibiotics were given to all patients and all had their devices removed, with 36.4% undergoing new device implantation. This is the first study of CIED infections in Lebanon and the Middle East. Local epidemiology and occupational exposure must be considered while contemplating the microbial etiology of infection. Close monitoring after device implantation is important in preventing device infection that carries high risk of morbidity and mortality.

Non-familial cardiomyopathies in Lebanon: exome sequencing results for five idiopathic cases.

BACKGROUND: Cardiomyopathies affect more than 0.5% of the general population. They are associated with high risk of sudden cardiac death, which can result from either heart failure or electrical abnormalities. Although different mechanisms underlie the various types of cardiomyopathies, a principal pathology is common to all and is usually at the level of the cardiac muscle. With a relatively high incidence rate in most countries, and a subsequent major health burden on both the families and governments, cardiomyopathies are gaining more attention by researchers and pharmaceutical companies as well as health government bodies. In Lebanon, there is no official data about the spectrum of the diseases in terms of their respective prevalence, clinical, or genetic profiles. METHODS: We used exome sequencing to unravel the genetic basis of idiopathic cases of cardiomyopathies in Lebanon, a relatively small country with high rates of consanguineous marriages. RESULTS: Five cases were diagnosed with different forms of cardiomyopathies, and exome sequencing revealed the presence of already documented or novel mutations in known genes in three cases: LMNA for an Emery Dreifuss Muscular Dystrophy case, PKP2 for an arrhythmogenic right ventricle dysplasia case, and MYPN for a dilated cardiomyopathy case. Interestingly two brothers with hypertrophic cardiomyopathy have a novel missense variation in NPR1, the gene encoding the natriuretic peptides receptor type I, not reported previously to be causing cardiomyopathies. CONCLUSION: Our results unravel novel mutations in known genes implicated in cardiomyopathies in Lebanon. Changes in clinical management however, require genetic profiling of a larger cohort of patients.

Incessant Long R-P Tachycardia.

A 13-year-old boy had a positive P wave in V1 with a negative P wave in lead I, aVL, and aVR, as well as a positive P wave in the inferior leads, which correlated with a left atrial appendage (LAA) atrial tachycardia (AT) focus. P-wave morphologies can provide clues regarding an AT's origin, and this P-wave negative in lead I favored LAA AT. Careful mapping along the atria and coronary sinus to determine the earliest site of activation for the surface P wave is a reliable method for precisely localizing the AT origin as a target for catheter ablation.

A Confused Pacemaker.

The electrocardiogram (ECG) raises the question of inappropriate device behavior and the possibility of ventricular lead oversensing causing failure of ventricular pacing. Careful analysis of the ECG proved that the mode of pacing was set to managed ventricular pacing (MVP) mode. The MVP mode should not be used in the setting of a complete atrioventricular conduction block.

Worsening thoracic impedance as a ventricular tachyarrhythmia risk.

The use of heart failure classification to identify patients with systolic dysfunction who are at risk for ventricular tachyarrhythmias (VAs), sudden cardiac death, and shocks from implantable cardioverter defibrillators (ICDs) is limited by its subjectivity. Measurement of thoracic impedance offers a more objective tool for assessing worsening of heart failure. We sought to look at the correlation between ventricular arrhythmia and heart failure as assessed objectively by thoracic impedance. We reviewed device interrogation data on thoracic impedance from ICD with Medtronic's OptiVol® feature (Medtronic Inc., Minneapolis, MN) at two medical centers. Data from the last two interrogations of the same device separated by at least 2 months were included. An OptiVol fluid index threshold of 60 represented early heart failure prior to appearance of symptoms. VAs included were ventricular fibrillation and/or ventricular tachycardia lasting more than 16 beats. Chi square distribution test was used in statistical data analysis. There were 24 VAs identified among the 322 interrogations reviewed (7.5%). Elevated OptiVol fluid index was seen in 71% (17/24), whereas normal OptiVol index was seen in the remaining 29% (7/24) of these interrogations with VA (P < .05). Our review shows that heart failure patients who have VA are approximately 2.5 times as likely to have worsening thoracic impedance as assessed objectively by the OptiVol fluid index. Careful monitoring of the OptiVol fluid index may identify a population at high risk of VA that merits more intense attention.

Extraction of a tunneled jugular defibrillator lead via a superior approach.

Extraction of cardiac implantable electrical devices (CIED) is becoming an increasing necessity. Infection is among the most frequent and serious complications associated with the surge of CIED implants. We describe the extraction of an infected cardiac resynchronization therapy-defibrillator (CRT-D) in a patient with a tunneled implantable cardioverter defibrillator (ICD) lead implanted from the right jugular vein.

Propafenone hepatotoxicity: report of a new case and review of the literature.

Propafenone is a class Ic antiarrhythmic drug. It is a beta-adrenergic blocker that causes bradycardia and bronchospasm. It is metabolized primarily in the liver. Its bioavailability and plasma concentration differ among patients under long-term therapy. They are genetically determined by the hepatic cytochrome P-450 2D6. Hepatic toxicity is highly uncommon. To date, only eight patients were reported in the reviewed world literature. In this article, one new case will be reported emphasizing the importance of medication history taking in patients presenting with new-onset liver enzymes abnormalities.

Cardiac Electrophysiology in Lebanon-Part II.

Systematic national effort to improve cardiac electrophysiology practice in Lebanon is lacking, and the quality improvement program mainly relates to individual efforts along with regulations, which are set as a "Road Map" by the Lebanese Arrhythmia Working Group. Lebanon currently has five electrophysiology laboratories. The "Road Map" mainly consists of creating a registry and a National Card for Electronic Device Holder, centralization of complex electrophysiology procedures in institutions where electrophysiologists are available, setting regulations to conform to international guidelines, and creating a National Arrhythmia Website and E-Journal. Most importantly, we emphasize that the practice of device checking must be performed by physicians with expertise and not by industry technicians.