Short- and Long-Term Risk of Lead Dislodgement Events: Real-World Experience From Product Surveillance Registry.

BACKGROUND: Lead dislodgement (LD) has been one of the most common early complications after cardiovascular implantable electronic device implant. However, limited data are available on the clinical characteristics and long-term outcomes of LD events. The aim of this study was to examine the risk factors, clinical significance, and management strategies of LD events after cardiovascular implantable electronic device implant. METHODS: This study was a retrospective cohort analysis of 20 683 patients who underwent cardiovascular implantable electronic device implant between January 1, 2010 and January 31, 2020 in Medtronic's Product Surveillance Registry, with a mean follow-up time of 3.3±2.5 SD years. The study population was divided into 2 groups: group A with LD events (N=350) and group B without LD events (N=20 333). RESULTS: During this period, 350 patients (1.69%) had LD events involving 371 leads (0.95%), among a total of 39 060 leads implanted. Passive fixation type (right atrium pacing lead, P=0.041), lower sensing amplitude (right ventricle defibrillating lead, P=0.020), and lower lead impedance at implant (right atrium pacing lead, P=0.009) were associated with increased LD risk. Multivariate analysis showed female sex (hazard ratio, 1.520, P=0.008) and higher body mass index (hazard ratio, 1.012, P=0.001) were independently associated with increased risk of LD events. LD events were not associated with significant changes in the long-term risks of cardiac and overall mortality. In group A, repositioning the dislodged leads increased the risk of a second LD event compared with implanting new leads (P=0.012). CONCLUSIONS: Female sex and higher body mass index were associated with higher risk of LD events in the Product Surveillance Registry. Among patients with dislodged leads, implanting new leads was associated with lower risk of future LD events. Further studies on how to reduce LD risk and to improve management of these events are needed. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT01524276.

A Practical Guide to Ultrasound-guided Venous Access During Implantation of Pacemakers and Defibrillators.

Ultrasound (US) guidance has been shown to be a safe and effective option for gaining access to the axillary vein during implantation of cardiovascular implantable electronic devices (CIEDs). However, US-based technique has not been universally adopted in CIED implantations performed in cardiac electrophysiology (EP) laboratories, despite potential advantages over other vascular access techniques. For this reason, not all cardiac electrophysiologists have been trained to use US guidance during CIED implantation. This review is intended to provide a practical guide to the use of US guidance to obtain axillary vein access in the EP laboratory setting.

Virtual multidisciplinary care for heart failure patients with cardiac resynchronization therapy devices during the Coronavirus Disease 2019 pandemic.

BACKGROUND: Heart failure (HF) patients with CRT devices are a vulnerable patient population during the Coronavirus Disease 2019 (COVID-19) Pandemic. It is important to develop innovative virtual care models to deliver multidisciplinary care while minimizing the risk of SARS-CoV2 exposure. OBJECTIVE: We aim to provide a description of how HF patients with CRT devices were assessed and managed in our virtual multidisciplinary clinic during the COVID-19 Pandemic. Clinical outcomes between this group of patients seen in virtual clinic and a historical cohort followed by in-person multi-disciplinary clinic prior to the pandemic were compared. METHOD: This is a retrospective cohort study of HF patients with CRT implants who were seen in the virtual multidisciplinary clinic from March 18th, 2020 to May 27th, 2020 (Virtual Visit Group, N = 43). A historical cohort of HF patients with CRT devices seen in the ReACT clinic in person during the same calendar time period in 2019 was used as a control group (In-Person Visit Group, N = 39). Both groups were followed until July 1st of the same calendar year (2020 or 2019) for clinical events. The primary outcome measure was a combined outcome of all-cause mortality and HF- or device-related hospitalizations during follow-up. The secondary outcome measures included patient satisfaction, COVID-19 infection, and other cardiovascular events. RESULTS: In the Virtual-Visit Group, 21 patients (48.8%) had their initial ReACT clinic visit (first visit after CRT implant) as a virtual visit; 22 patients (51.2%) had prior in-person ReACT clinic visits before the first virtual visit. During the virtual visits, 12 patients had either potential cardiac symptoms or significant device interrogation findings that required clinical intervention. In post-virtual clinic patient satisfaction survey, all 22 patients surveyed (100%) reported being very satisfied or satisfied with the overall experience of the virtual clinic, and every patient (100%) said they would like to use telemedicine again. During a median follow-up period of 82 days (interquartile range [IQR] 61-96 days), one patient died from pneumonia of unclear etiology at an outside hospital, without documentation of COVID-19 positivity. No patient was hospitalized for HF- or arrhythmia-related complications. No patient was diagnosed with COVID-19. Compared with the In-Person Visit Group, there was no significant increase in mortality or major cardiovascular events in the Virtual-Visit Group (2.3% versus 5.1%, P = 0.60). CONCLUSIONS AND RELEVANCE: Virtual multidisciplinary care was feasible for HF patients with cardiac resynchronization therapy devices and achieved good patient satisfaction. Virtual care was not associated with short-term increase in adverse events for HF patients with CRT device during the COVID-19 Pandemic. This virtual care model could help promote the adoption of digital health methodology for high-risk patients with multiple cardiac comorbidities.

Catheter Ablation for Brugada Syndrome.

We report a case of catheter ablation of Brugada syndrome in a patient with refractory ventricular fibrillation despite quinidine therapy. We performed epicardial substrate mapping, which identified an area of abnormal fractionated, prolonged electrogram in the anterior right ventricular outflow tract. Warm saline infusion into the pericardial space induced further delay of the local electrogram, consistent with Brugada syndrome physiology. Coronary angiography confirmed that the area was distant from major coronary arteries. Ablation was performed in this area, which eliminated local abnormal electrograms and led to the disappearance of coved-type ST elevation in V1-V2. No ventricular fibrillation had recurred by five months of follow-up.

Causal effects of plasma lipids on the risk of atrial fibrillation: A multivariable mendelian randomization study.

BACKGROUND AND AIMS: Observational studies have suggested that plasma lipids contribute substantially to cardiovascular disease, but "cholesterol paradox" in atrial fibrillation (AF) remains. We sought to investigate the causal effects of lipid profiles on the risk of AF. METHODS AND RESULTS: Two-sample Mendelian randomization (MR) framework was implemented to examine the causality of association. Summary estimations of genetic variants associated with low density lipoprotein (LDL)-cholesterol, high density lipoprotein (HDL)-cholesterol, total cholesterol, triglycerides, lipoprotein-a [Lp(a)], apolipoprotein A1 (ApoA 1), and apolipoprotein B (ApoB) were 81, 99, 96, 61, 30, 10, and 23 single nucleotide polymorphisms, respectively. Genetic association with AF were retrieved from a genome-wide association study that included 1,030,836 individuals. The complications for AF were predefined as cardioembolic stroke (CES) and heart failure (HF). In the multivariable MR, the odds ratios for AF per standard deviation (SD) increase were 1.030 (95% confidence interval (CI) 0.979-1.083; P = 0.257) for LDL-cholesterol, 0.986 (95% CI 0.931-1.044; P = 0.622) for HDL-cholesterol, 0.965 (95% CI 0.896-1.041; P = 0.359) for triglycerides, 1.001 (95% CI 1.000-1.003; P = 0.023) for Lp(a), 1.017 (95% CI 0.966-1.070; P = 0.518) for ApoA1, and 1.002 (95% CI 0.963-1.043; P = 0.923) for ApoB. There was no evidence that other lipid components were causally associated with AF, CES, or HF, other than for a marginal association between triglycerides and HF. CONCLUSIONS: This MR study provides robust evidence that high Lp(a) increases the risk of AF, suggesting that interventions targeting Lp(a) may contribute to the primary prevention of AF.

Comparison between TightRail rotating dilator sheath and GlideLight laser sheath for transvenous lead extraction.

BACKGROUND: There are limited data on the comparative analyses of TightRail rotating dilator sheath (Philips) and laser sheath for lead extraction. OBJECTIVE: To evaluate the effectiveness and safety of the TightRail sheath as a primary or secondary tool for transvenous lead extraction (TLE). METHODS: Retrospective cohort analysis of 202 consecutive patients who underwent TLE using either TightRail sheath and/or GlideLight laser sheath (Philips) in our hospital. The study population was divided into three groups: Group A underwent TLE with laser sheath only (N = 157), Group B with TightRail sheath only (N = 22), and Group C with both sheaths (N = 23). RESULTS: During this period, 375 leads in 202 patients were extracted, including 297 leads extracted by laser sheath alone, 45 leads by TightRail sheath alone, and 33 by both TightRail sheath and laser sheaths. The most common indications included device infection (44.6%) and lead-related complications (44.1%). The median age of leads was 8.9 years. TightRail sheath (Group B) achieved similar efficacy as a primary extraction tool compared with laser sheath (Group A), with complete procedure success rate of 93.3% (vs. 96.6%, P = .263) and clinical success rate of 100.0% (vs. 98.1%, P = .513). Among 32 leads in which Tightrail was used after laser had failed (Group C), the complete procedure success rate was 75.8%. No significant difference in procedural adverse events was observed. CONCLUSION: Our single-center experience confirms that the TightRail system is an effective first-line and second-line method for TLE. Further investigation is required to guide the selection of mechanical and laser sheaths in lead extraction cases.

Atrial Fibrillation-Mediated Cardiomyopathy.

AF-mediated cardiomyopathy (AMC) is an important reversible cause of heart failure that is likely underdiagnosed in today's clinical practice. AMC describes AF either as the sole cause for ventricular dysfunction or exacerbating ventricular dysfunction in patients with existing cardiomyopathy or heart failure. Studies suggest that irreversible ventricular and atrial remodeling can occur in AMC, making timely diagnosis and intervention critical to optimize clinical outcome. Clinical correlation between AF onset/burden and progression of cardiomyopathy/heart failure symptoms provides strong evidence for the diagnosis of AMC. Cardiac MRI, continuous cardiac monitoring, and biomarkers are important diagnostic tools. From the therapeutic standpoint, early data suggest that AF ablation may improve long-term outcomes in AMC patients compared with medical rate and rhythm control. Patients with more AF burden and less severe underlying structural heart disease are more likely to experience left ventricle function recovery with successful AF ablation. Despite recent advances, significant knowledge gaps exist in our understanding of the epidemiology, mechanisms, diagnosis, management strategies, and prognosis of AMC.

Implications of Neurological Status on Defibrillator Therapy and Long-Term Mortality of Sudden Cardiac Arrest Survivors.

OBJECTIVES: This study sought to investigate the impact of the neurological status of sudden cardiac arrest (SCA) survivors on implantable cardioverter-defibrillator (ICD) insertion and long-term mortality. BACKGROUND: The neurological status of SCA survivors may impact the decision to insert an ICD insertion and influence long-term survival. METHODS: In 1,433 survivors of SCA between 2002 and 2012, we examined the neurological status immediately after the arrest using the Pittsburgh Cardiac Arrest Category (PCAC) and prior to hospital discharge using the cerebral performance category (CPC) score. Patients were followed up to the endpoints of ICD implantation and all-cause mortality. RESULTS: Over a median follow-up period of 3.6 years, 389 (27%) patients received an ICD, and 674 (47%) died. The PCAC (adjusted hazard ratio [HR]: 0.79; 95% confidence interval [CI]: 0.69 to 0.90) and CPC (adjusted HR: 0.73; 95% CI: 0.64 to 0.84) scores were highly predictive of the time to ICD insertion and of all-cause mortality (PCAC score, adjusted HR: 1.39; 95% CI: 1.24 to 1.57; CPC score, adjusted HR: 2.03; 95% CI: 1.77 to 2.34). ICD therapy was associated with better survival even after adjusting for neurological status (HR: 0.56; 95% CI: 0.43 to 0.73). A significant proportion of patients in the worse CPC categories had a >1-year survival after the index SCA. CONCLUSIONS: In SCA survivors, worse neurological performance was associated with lower likelihood of ICD insertion and higher mortality. ICD insertion was associated with improved survival even after accounting for neurological performance. ICD discussion should therefore not be omitted in these patients.

Implantable Defibrillator Therapy in Cardiac Arrest Survivors With a Reversible Cause.

BACKGROUND: Current guidelines recommend implantable cardioverter-defibrillator (ICD) therapy in survivors of sudden cardiac arrest (SCA), except in those with completely reversible causes. We sought to examine the impact of ICD therapy on mortality in survivors of SCA associated with reversible causes. METHODS AND RESULTS: We evaluated the records of 1433 patients managed at our institution between 2000 and 2012 who were discharged alive after SCA. A reversible and correctable cause was identified in 792 (55%) patients. Reversible SCA cause was defined as significant electrolyte or metabolic abnormality, evidence of acute myocardial infarction or ischemia, recent initiation of antiarrhythmic drug or illicit drug use, or other reversible circumstances. Of the 792 SCA survivors because of a reversible and correctable cause (age 61±15 years, 40% women), 207 (26%) patients received an ICD after their index SCA. During a mean follow-up of 3.8±3.1 years, 319 (40%) patients died. ICD implantation was highly associated with lower all-cause mortality (P<0.001) even after correcting for unbalanced baseline characteristics (P<0.001). In subgroup analyses, only patients whose SCA was not associated with myocardial infarction extracted benefit from ICD (P<0.001). CONCLUSIONS: In survivors of SCA because of a reversible and correctable cause, ICD therapy is associated with lower all-cause mortality except if the SCA was because of myocardial infarction. These data deserve further investigation in a prospective multicenter randomized controlled trial, as they may have important and immediate clinical implications.

Impact of Race on Outcome of Patients Undergoing Rhythm Control of Atrial Fibrillation.

Racial disparities between African American (AA) and White patients have been documented in cardiovascular disease. We investigated whether these disparities exist in patients undergoing rhythm control for atrial fibrillation (AF). 5873 AF patients (241 AA) were followed to the endpoint of death, stroke, or AF recurrence. Invasive procedures for AF rhythm control were examined in both racial groups. Over a mean follow-up time of 40 months, AA patients had a higher adjusted risk of death [HR 1.39, 95% CI 1.00-1.92, p = 0.043] and stroke [HR 1.90, 95% CI 1.13-3.15, p = 0.013] but a lower risk of AF recurrence [HR 0.79, 95% CI 0.63-0.97, p = 0.026]. In addition, AA patients were less likely to undergo AF ablation (p = 0.006) or surgical maze (p = 0.032) procedures compared to White patients, possibly due to the lower rates of AF recurrence. Significant racial disparities exist in the management and outcomes of AA and White patients undergoing rhythm control management for AF.

Gender differences in management and clinical outcomes of atrial fibrillation patients.

BACKGROUND: Prior research has identified gender differences in the epidemiology and clinical management of atrial fibrillation (AF). The primary aim of this study is to systematically analyze a cohort of AF men and women and evaluate their baseline demographics, treatment, and clinical outcomes by gender. METHODS: We examined the records of 5976 (42% women) consecutive AF patients who were prescribed at least one anti-arrhythmic drug between 2006 and 2013. From this cohort, 4311 (72%) patients had anticoagulation data available and were included in the final analysis. Time to clinical events was assessed using survival analysis and adjusted for covariates using Cox regression. RESULTS: Compared to men, women were older (73 years vs. 67 years, p<0.001), had higher CHADS2 scores (1.9 vs. 1.5, p<0.001), and fewer cardiac comorbidities. Compared to men, women were more often prescribed sotalol and less often dofetilide (p<0.001). Women were also less likely to be anticoagulated (76.8% vs. 82.5%, p<0.001). Over a mean follow-up of 40 months, women were more likely to die (HR 1.21, p=0.037) or to have an ischemic stroke (HR 1.35, p=0.058). Women also had higher rates of atrioventricular-nodal ablation (adjusted HR 2.11, p<0.001) and pacemaker implantation (adjusted HR 1.69, p<0.001) procedures, but lower rates of electrical cardioversions, AF ablations, and maze surgeries. CONCLUSIONS: There are significant gender differences in baseline demographics and clinical outcomes of AF patients. Women have higher mortality and ischemic strokes and are less often prescribed anticoagulation therapy despite higher CHADS2 scores. These data have important clinical implications.

Comparative effectiveness of antiarrhythmic drugs for rhythm control of atrial fibrillation.

INTRODUCTION: Although there are many different antiarrhythmic drugs (AADs) approved for rhythm management of atrial fibrillation (AF), little comparative effectiveness data exist to guide drug selection. METHODS: We followed 5952 consecutive AF patients who were prescribed amiodarone (N=2266), dronedarone (N=488), dofetilide (N=539), sotalol (N=1718), or class 1C agents (N=941) to the primary end point of AF recurrence. RESULTS: Median follow-up time was 18.2 months (range 0.1-101.6 months). Patients who were prescribed amiodarone had the highest, while patients on class 1C agents had the lowest baseline CHA2DS2-VASc score, Charlson comorbidity index, and burden of comorbid illnesses including coronary artery disease, congestive heart failure, diabetes mellitus, hyperlipidemia, chronic obstructive lung disease, chronic kidney disease, or cancer (p<0.05 for all comparisons). After adjusting for baseline characteristics, using dronedarone as benchmark, amiodarone [hazard ratio (HR) 0.58, p<0.001], class 1C agents (HR 0.70, p<0.001), and sotalol (HR 0.79, p=0.008), but not dofetilide (HR 0.87, p=0.178) were associated with less AF recurrence. In addition, compared to dronedarone, amiodarone and class 1C agents were associated with lower rates of admissions for AF (HR 0.55, p<0.001 for amiodarone; HR 0.71, p=0.021 for class 1C agents) and all-cause mortality was lowest in patients treated with class 1C agents (HR 0.42, p=0.018). The risk of stroke was similar among all groups. CONCLUSION: Compared with dronedarone, amiodarone, class 1C agents, and sotalol are more effective for rhythm control, while dofetilide had similar efficacy. These findings have important implications for clinical practice.

Mortality risk of long-term amiodarone therapy for atrial fibrillation patients without structural heart disease.

BACKGROUND: Amiodarone is often prescribed in the management of atrial fibrillation (AF) but is known to cause significant end-organ toxicities. In this study, we examined the impact of amiodarone on all-cause mortality in AF patients with structurally normal hearts. METHODS: We performed a retrospective cohort analysis of all AF patients with structurally normal hearts who were prescribed antiarrhythmic drugs (AAD) for rhythm control of AF at our institution from 2006 to 2013 (n = 2,077). Baseline differences between the amiodarone (AMIO: n = 403) and other AADs (NON-AMIO: n = 1,674) groups were corrected for using propensity score matching. RESULTS: Amiodarone use as first-line therapy decreased significantly with a higher degree of prescriber specialization in arrhythmia management (31%, 22%, and 9% for primary care physicians, general cardiologists and cardiac electrophysiologists, respectively, p < 0.001). After propensity score matching, baseline comorbidities were balanced between the AMIO and NON-AMIO groups. Over a median follow-up of 28.2 months (range 6.0-100.9 months), amiodarone was associated with increased all-cause (HR 2.41, p = 0.012) and non-cardiac (HR 3.55, p = 0.008) mortality, but not cardiac mortality. AF recurrence and cardiac hospitalizations were similar between the two study groups. CONCLUSIONS: Amiodarone treatment of AF is associated with increased mortality in patients without structural heart disease and therefore should be avoided or only used as a second-line therapy, when other AF therapies fail. Adherence to guideline recommendations in the management of AF patients impacts clinical outcome.

Risk of Stroke and Death in Atrial Fibrillation by Type of Anticoagulation: A Propensity-Matched Analysis.

BACKGROUND: We examined the effect of novel oral anticoagulants (NOACs) compared to warfarin on the risk of death or stroke in atrial fibrillation (AF) patients in every day clinical practice. METHODS: We examined a cohort of 2,836 AF patients, of whom 2,253 were prescribed warfarin and 583 were prescribed an NOAC. Patients with glomerular filtration rate < 30 mg/mL or history of significant valvular heart disease were excluded. Patients were followed to primary end points of death or stroke. Propensity matching was used to adjust for differences in baseline characteristics between the groups. RESULTS: Compared to patients in the NOAC group, patients on warfarin had more comorbidities and higher CHADS2 and CHA2 DS2 -VASc scores (1.7 vs 1.3 for CHADS2 , 2.8 vs 2.2 for CHA2 DS2 -VASc, P < 0.0001 for both). After adjusting for differences in baseline characteristics, NOAC use was associated with significant reduction in all-cause mortality compared to warfarin (hazard ratio [HR] = 0.47, 95% confidence interval [CI; 0.3-0.8], P = 0.006) but not stroke, over a median follow-up of 42.5 months. The difference in mortality persisted after propensity score matching (HR = 0.51, 95% CI [0.28-0.93], P = 0.03). CONCLUSIONS: Compared to warfarin, NOAC use is associated with decreased all-cause mortality but not stroke risk. These data from real-life clinical practice add to existing evidence for decreased mortality among patients prescribed NOACs compared to warfarin.

Patient outcomes according to adherence to treatment guidelines for rhythm control of atrial fibrillation.

BACKGROUND: Although guidelines for antiarrhythmic drug therapy in atrial fibrillation (AF) were published in 2006, it remains uncertain whether adherence to these guidelines affects patient outcomes. METHODS AND RESULTS: We retrospectively evaluated the records of 5976 consecutive AF patients who were prescribed at least 1 antiarrhythmic drug between 2006 and 2013. Patients with 1 or more prescribed antiarrhythmic drugs that did not comply with guideline recommendations comprised the non-guideline-directed group (=2920); the remainder constituted the guideline-directed group (=3056). Time to events was assessed using the survival analysis method and adjusted for covariates using Cox regression. Rates of adherence to the guidelines increased significantly with a higher degree of prescriber specialization in arrhythmias (49%, 55%, and 60% for primary care physicians, general cardiologists, and cardiac electrophysiologists, respectively, P=0.001) for the first prescribed antiarrhythmic drug. Compared to the non-guideline-directed group, the guideline-directed group had higher rates of heart failure, but lower baseline CHADS2-VASc scores (P<0.001) and lower rates of coronary artery disease, valvular disease, hypertension, hyperlipidemia, pulmonary disease, and renal insufficiency (P<0.05 for all). During 45 ± 26 months follow-up, the guideline-directed group had a lower risk of AF recurrence (hazard ratio=0.86, 95% CI=0.80 to 0.93), fewer hospital admissions for AF (hazard ratio=0.87, 95% CI=0.79 to 0.97), and fewer procedures for recurrent AF, including electrical cardioversion, pacemaker implantation, and atrioventricular nodal ablation (P<0.01 for all). The mortality and stroke risks were similar between the groups. CONCLUSIONS: Adherence to published guidelines in the antiarrhythmic management of AF is associated with improved patient outcomes.

Radiologic and clinical bronchiectasis associated with autosomal dominant polycystic kidney disease.

BACKGROUND: Polycystin 1 and 2, the protein abnormalities associated with autosomal dominant polycystic kidney disease (ADPKD), are also found in airway cilia and smooth muscle cells. There is evidence of increased radiologic bronchiectasis associated with ADPKD, though the clinical and functional implications of this association are unknown. We hypothesized an increased prevalence of both radiologic and clinical bronchiectasis is associated with APDKD as compared to non-ADPKD chronic kidney disease (CKD) controls. MATERIALS AND METHODS: A retrospective case-control study was performed at our institution involving consecutive ADPKD and non-ADPKD chronic kidney disease (CKD) patients seen over a 13 year period with both chest CT and PFT. CTs were independently reviewed by two blinded thoracic radiologists. Manually collected clinical data included symptoms, smoker status, transplant history, and PFT findings. RESULTS: Ninety-two ADPKD and 95 non-ADPKD CKD control patients were compared. Increased prevalence of radiologic bronchiectasis, predominantly mild lower lobe disease, was found in ADPKD patients compared to CKD control (19 vs. 9%, P = 0.032, OR 2.49 (CI 1.1-5.8)). After adjustment for covariates, ADPKD was associated with increased risk of radiologic bronchiectasis (OR 2.78 (CI 1.16-7.12)). Symptomatic bronchiectasis occurred in approximately a third of ADPKD patients with radiologic disease. Smoking was associated with increased radiologic bronchiectasis in ADPKD patients (OR 3.59, CI 1.23-12.1). CONCLUSIONS: Radiological bronchiectasis is increased in patients with ADPKD particularly those with smoking history as compared to non-ADPKD CKD controls. A third of such patients have symptomatic disease. Bronchiectasis should be considered in the differential in ADPKD patients with respiratory symptoms and smoking history.