Publications by authors named "Andrea Natale"

819 Publications

Cardiac Conduction System Disorders.

Card Electrophysiol Clin 2021 Dec;13(4):xiii

Texas Cardiac Arrhythmia Institute, Center for Atrial Fibrillation at St. David's Medical Center, 1015 East 32nd Street, Suite 516, Austin, TX 78705, USA. Electronic address:

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http://dx.doi.org/10.1016/j.ccep.2021.07.007DOI Listing
December 2021

New evidence of direct oral anticoagulation therapy on cardiac valve calcifications, renal preservation and inflammatory modulation.

Int J Cardiol 2021 Oct 21. Epub 2021 Oct 21.

Innovation and Brand Reputation Unit, Papa Giovanni XXIII Hospital, Bergamo, Italy.

Background: Rivaroxaban is a direct inhibitor of activated Factor X (FXa), an anti-inflammatory protein exerting a protective effect on the cardiac valve and vascular endothelium. We compare the effect of Warfarin and Rivaroxaban on inflammation biomarkers and their contribution to heart valve calcification progression and renal preservation in a population of atrial fibrillation (AF) patients with chronic kidney disease (CKD) stage 3b - 4.

Methods: This was an observational, multicenter, prospective study enrolling 347 consecutive CKD stage 3b - 4 patients newly diagnosed with AF: 247 were treated with Rivaroxaban and 100 with Warfarin. Every 12 months, we measured creatinine levels and cardiac valve calcification via standard trans-thoracic echocardiogram, while plasma levels of inflammatory mediators were quantified by ELISA at baseline and after 24 months.

Results: Over a follow-up of 24 months, long-term treatment with Rivaroxaban was associated with a significative reduction of cytokines. Patients treated with Rivaroxaban experienced a more frequent stabilization/regression of valve calcifications comparing with patients treated with Warfarin. Rivaroxaban use was related with an improvement in kidney function in 87.4% of patients, while in those treated with Warfarin was reported a worsening of renal clearance in 98% of cases. Patients taking Rivaroxaban experienced lower adverse events (3.2% vs 49%, p-value <0.001).

Conclusions: Our findings suggest that Rivaroxaban compared to Warfarin is associated with lower levels of serum markers of inflammation. The inhibition of FXa may exert an anti-inflammatory effect contributing to reduce the risk of cardiac valve calcification progression and worsening of renal function.
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http://dx.doi.org/10.1016/j.ijcard.2021.10.025DOI Listing
October 2021

Effects of opioid receptor agonist and antagonist medications on electrocardiogram changes and presentation of cardiac arrhythmia: review article.

J Interv Card Electrophysiol 2021 Oct 21. Epub 2021 Oct 21.

Saint Joseph Hospital, Lexington, KY, USA.

Background/purpose: Mortality associated with prescription opioids has significantly increased over the past few decades and is considered a global pandemic. Prescribed opioids can cause cardiac arrhythmias, leading to fatal outcomes and unexpected death, even in the absence of structural cardiac disease. Despite the extent of cardiac toxicity and death associated with these medications, there is limited data to suggest their influences on cardiac electrophysiology and arrhythmias, with the exception of methadone. The goal of our review is to describe the possible mechanisms and to review the different ECG changes and arrhythmias that have been reported.

Methods: A literature search was performed using Google Scholar, PubMed, Springer, Ovid, and Science Direct to identify studies that demonstrated the use of prescription opioids leading to electrocardiogram (ECG) changes and cardiac arrhythmias.

Results: Many of the commonly prescribed opioid medications can uniquely effect the ECG, and can lead to the development of various cardiac arrhythmias. One of the most significant side effects of these drugs is QTc interval prolongation, especially when administered to patients with a baseline risk for QTc prolongation. A prolonged QTc interval can cause lethal torsades de pointes and ventricular fibrillation. Obtaining an ECG at baseline, following a dosage increase, or after switching an opioid medication, is appropriate in patients taking certain prescribed opioids. Opioids are often used first line for the treatment of acute and chronic pain, procedural sedation, medication opioid use disorders, and maintenance therapy.

Conclusions: To reduce the risk of cardiac arrhythmias and to improve patient outcomes, consideration of accurate patient selection, concomitant medications, electrolyte monitoring, and vigilant ECG monitoring should be considered.
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http://dx.doi.org/10.1007/s10840-021-01072-1DOI Listing
October 2021

Half-Dose Direct Oral Anticoagulation Versus Standard Antithrombotic Therapy After Left Atrial Appendage Occlusion.

JACC Cardiovasc Interv 2021 Oct 7. Epub 2021 Oct 7.

Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas, USA; Interventional Electrophysiology, Scripps Clinic, La Jolla, California, USA; Department of Cardiology, MetroHealth Medical Center, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.

Objectives: This study evaluated the long-term efficacy of a standard antithrombotic strategy versus half-dose direct oral anticoagulation (DOAC) after Watchman implantation.

Background: No consensus currently exists on the selection of the most effective antithrombotic strategy to prevent device-related thrombosis (DRT) in patients undergoing endocardial left atrial appendage closure.

Methods: After successful left atrial appendage closure, consecutive patients were prescribed a standard antithrombotic strategy (SAT) or long-term half-dose DOAC (hdDOAC). The primary composite endpoint was DRT and thromboembolic (TE) and bleeding events.

Results: Overall, 555 patients (mean age 75 ± 8 years, 63% male; median CHADS-VASc [congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65-74 years, sex category] score 4 [interquartile range (IQR): 3-6]; median HAS-BLED [hypertension, abnormal renal or liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol] score 3 [IQR: 2-4]) were included. Patients were categorized into 2 groups (SAT: n = 357 vs hdDOAC: n = 198). Baseline clinical characteristics were similar between groups. The median follow-up duration was 13 (IQR: 12-15) months. DRT occurred in 12 (2.1%) patients, all in the SAT group (3.4% vs 0.0%; log-rank P = 0.009). The risk of nonprocedural major bleeding was significantly more favorable in the hdDOAC group (0.5% vs. 3.9%; log-rank P = 0.018). The rate of the primary composite endpoint of DRT and TE and major bleeding events was 9.5% in SAT patients and 1.0% in hdDOAC patients (hazard ratio: 9.8; 95% confidence interval: 2.3-40.7; P = 0.002).

Conclusions: After successful Watchman implantation, long-term half-dose DOAC significantly reduced the risk of the composite endpoint of DRT and TE and major bleeding events compared with a standard, antiplatelet-based, antithrombotic therapy.
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http://dx.doi.org/10.1016/j.jcin.2021.07.031DOI Listing
October 2021

Recovery of Conduction Following High-Power Short-Duration Ablation in Patients With Atrial Fibrillation: A Single-Center Experience.

Circ Arrhythm Electrophysiol 2021 Oct 29;14(10):e010096. Epub 2021 Sep 29.

Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin (S.M., C.T., D.G.D.R., C.G., B.M., A.Q.M., A.A.-A., J.D.B., M.B., G.J.G., R.H., L.D.B., A.N.).

[Figure: see text].
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http://dx.doi.org/10.1161/CIRCEP.121.010096DOI Listing
October 2021

Intraprocedural PRAETORIAN score for early assessment of S-ICD implantation: A proof-of-concept study.

J Cardiovasc Electrophysiol 2021 Sep 28. Epub 2021 Sep 28.

Cardiology Unit, ASST Fatebenefratelli-Sacco, Luigi Sacco University Hospital, Milan, Italy.

Introduction: The PRAETORIAN score (PS) was developed to assess the implant position and predict defibrillation success of the subcutaneous implantable cardioverter defibrillators (S-ICD). The main critique moved to the routine use of PS has been its postprocedural timing, that limits its usefulness on procedure guidance. The aim of this proof-of-concept study was to assess the feasibility of an intraprocedural use of PS.

Methods: Forty consecutive patients undergoing S-ICD implantation were enrolled. Intraprocedural PS (IP-PS) obtained with fluoroscopy before closure of the pocket and postprocedural PS (PP-PS) obtained with two-views chest X-ray were compared. Intraprocedural data and PS were compared with the historic cohorts of the involved institutions.

Results: When assessing IP-PS and PP-PS, a complete overall agreement was observed (100%, 1.00-κ; p < .001). When assessing a per-step agreement, a very high-degree of concordance in evaluating Step 1 of the PS was observed (95%, 0.81-κ; p < .001). A complete agreement in Step 2-3 (100%, 1.00-κ; p < .001) of the PS was reported. In comparison with our historical cohort, procedural time in the IP-PS cohort did not increase (45 [41-52] vs. 45 [39-49] min; p = .351) while the expected increase in fluoroscopy time resulted scarce (15 [10-15] s).

Conclusion: An IP-PS can be reliably obtained using fluoroscopy guidance during S-ICD implantation, without a significant increase in procedural duration and may serve as guidance for implanting physicians, to avoid postprocedural S-ICD repositioning, leading to patient discomfort and significantly enhancing infective risks. IP-PS showed a very high agreement with the PP-PS obtained from two-views chest X-ray.
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http://dx.doi.org/10.1111/jce.15254DOI Listing
September 2021

Endomyocardial Biopsy: The Forgotten Piece in the Arrhythmogenic Cardiomyopathy Puzzle.

J Am Heart Assoc 2021 Oct 25;10(19):e021370. Epub 2021 Sep 25.

Heart Rhythm Center Department of Clinical Electrophysiology and Cardiac Pacing Monzino Cardiology CenterIRCCS Milano Italy.

Background Endomyocardial biopsy (EMB) is part of 2010 Task Force Criteria (TFC) for arrhythmogenic right ventricular cardiomyopathy (ARVC). However, its usage has been curtailed because of its low presumed diagnostic yield, and it is now a poorly used tool. This study aims to analyze the contribution of EMB to the final diagnosis of ARVC. Methods and Results We included 104 consecutive patients evaluated for a suspicion of ARVC, who were referred for EMB. Patients with suspected left dominant pattern were excluded from the primary analysis. Subjects were initially stratified according to TFC without considering EMB. After EMB, patients were reclassified accordingly, and the reclassification rate was calculated. EMB yielded a diagnostic finding in 92 patients (85.5%). After including EMB evaluation, 20 (43%) more patients "at risk" received a definite diagnosis of ARVC. Overall, 59 patients received a definite diagnosis of ARVC, 34% only after EMB. EMB appeared to be the better-performing exam with respect to the final diagnosis (β, 2.2; area uder the curve, 0.73; <0.05). The reclassification improvement after EMB measured 28%. TFC score increased from 3.5±1.3 to 4.3±1.4 (<0.001). Notably, active inflammation was present in 6 (10%) patients. Minor complications were reported in only 2% of the cohort. In patients with suspected left-dominant disease, conventional TFC performed poorly. Conclusions Electroanatomic voltage mapping-guided EMB was safe and yielded an optimal diagnostic yield. It allowed upgrading of the diagnosis of nearly one-third of the patients considered "at risk." Classical TFC without EMB performed poorly in patients with the left dominant form of ARVC.
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http://dx.doi.org/10.1161/JAHA.121.021370DOI Listing
October 2021

Evaluation of a novel cardiac signal processing system for electrophysiology procedures: The PURE EP 2.0 study.

J Cardiovasc Electrophysiol 2021 Sep 23. Epub 2021 Sep 23.

Texas Cardiac Arrhythmia Institute, Austin, Texas, USA.

Background: Intracardiac electrogram data remain one of the primary diagnostic inputs guiding complex ablation procedures. However, the technology to collect, process, and display intracardiac signals has known shortcomings and has not advanced in several decades.

Objective: The purpose of this study was to evaluate a new signal processing platform, the PURE EP™ system (PURE), in a multi-center, prospective study.

Methods: Intracardiac signal data of clinical interest were collected from 51 patients undergoing ablation procedures with PURE, the signal recording system, and the 3D mapping system at the same time stamps. The samples were randomized and subjected to blinded, controlled evaluation by three independent electrophysiologists to determine the overall quality and clinical utility of PURE signals when compared to conventional sources. Each reviewer assessed the same (92) signal sample sets and responded to (235) questions using a 10-point rating scale. If two or more reviewers rated the PURE signal higher than the control, it was deemed superior.

Results: A total of 93% of question responses showed consensus amongst the blinded reviewers. Based on the ratings for each pair of signals, a cumulative total of 164 PURE signals out of 218 (75.2%) were statistically rated as Superior for this data set (p < .001). Only 14 PURE signals out of 218 were rated as Inferior (6.4%).

Conclusion: The PURE intracardiac signals were statistically rated as superior when compared to conventional systems.
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http://dx.doi.org/10.1111/jce.15250DOI Listing
September 2021

Ventricular arrhythmias in athletes: Role of a comprehensive diagnostic workup.

Heart Rhythm 2021 Sep 15. Epub 2021 Sep 15.

Centro Cardiologico Monzino IRCCS, Milan, Italy; Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.

Background: Ventricular arrhythmias (VAs) represent a critical issue with regard to sports eligibility assessment in athletes. The ideal diagnostic evaluation of competitive and leisure-time athletes with complex VAs has not been clearly defined.

Objective: The purpose of this study was to assess the clinical implications of invasive electrophysiological assessments and endomyocardial biopsy (EMB) among athletes with VAs.

Methods: We evaluated 227 consecutive athletes who presented to our institutions after being disqualified from participating in sports because of VAs. After noninvasive tests, electrophysiological study (EPS), electroanatomic mapping (EAM), and EAM- or cardiac magnetic resonance imaging-guided EMB was performed, following a prespecified protocol. Sports eligibility status was redefined at 6-month follow-up.

Results: From our sample, 188 athletes (82.8%) underwent EAM and EPS, and 42 (15.2%) underwent EMB. A diagnosis of heart disease could be formulated in 30% of the study population (67/227; 95% confidence interval [CI] 0.24-0.36) after noninvasive tests; in 37% (83/227; 95% CI 31%-43%) after EPS and EAM; and in 45% (102/227; 95% CI 39%-51%) after EMB. In the subset of athletes undergoing EMB, invasive diagnostic workup allowed diagnostic reclassification of half of the athletes (n = 21 [50%]). Reclassification was particularly common among subjects without definitive findings after noninvasive evaluation (n = 23; 87% reclassified). History of syncope, abnormal echocardiogram, presence of late gadolinium enhancement, and abnormal EAM were linked to sports ineligibility at 6-month follow-up.

Conclusion: A comprehensive invasive workup provided additional diagnostic elements and could improve the sports eligibility assessment of athletes presenting with VAs. The extensive invasive evaluation presented could be especially helpful when noninvasive tests show unclear findings.
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http://dx.doi.org/10.1016/j.hrthm.2021.09.013DOI Listing
September 2021

Rhythm- Versus Rate-Control in Atrial Fibrillation-ELECTRAM Investigators.

Am J Ther 2021 Sep-Oct 01;28(5):e581-e583

Kansas City Heart Rhythm Institute and Research Foundation, Kansas City, KS.

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http://dx.doi.org/10.1097/MJT.0000000000001349DOI Listing
September 2021

His-bundle pacing following transcatheter aortic valve replacement.

Pacing Clin Electrophysiol 2021 Oct 1;44(10):1786-1789. Epub 2021 Sep 1.

Kansas City Heart Rhythm Institute and Research Foundation, Kansas City, Kansas, USA.

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http://dx.doi.org/10.1111/pace.14351DOI Listing
October 2021

Lessons learned from experimental models of cerebrovascular aneurysms to improve endocardial device occlusion of the left atrial appendage.

Heart Rhythm O2 2021 Aug 23;2(4):423-430. Epub 2021 Jun 23.

The Texas Cardiac Arrhythmia Institute at St. David's Medical Center, Austin, Texas.

In patients with atrial fibrillation, left atrial appendage (LAA) occlusion devices represent an alternative to anticoagulation but are associated with residual peridevice leaks (PDLs) and device-related thrombi (DRT). Similarly, cerebrovascular aneurysms can be treated with coil embolization, but pericoil leaks represent a significant limitation. In experimental models of cerebrovascular aneurysms, endothelial denudation achieved independently with (1) embolization with radioactive coils, (2) mechanical removal of the endothelium, or (3) radiofrequency ablation was dramatically effective in preventing or eliminating pericoil leaks. Anatomical, physiological, and blood flow similarities exist between the LAA and saccular aneurysms. Concepts developed in treating aneurysm leaks can be used to treat similar problems in the LAA. Learning from aneurysms, we conceived of a novel technique to denude local endothelium and thus eliminate residual leaks around LAA-occlusion devices. We recently successfully tested this hypothesis in patients with a PDL in a prospective manner in a multicenter study. In this article, we expand on the rationale of the technique developed to close PDLs and potentially also prevent DRTs.
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http://dx.doi.org/10.1016/j.hroo.2021.06.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8369292PMC
August 2021

Targeting non-pulmonary vein triggers in persistent atrial fibrillation: results from a prospective, multicentre, observational registry.

Europace 2021 Aug 21. Epub 2021 Aug 21.

Texas Cardiac Arrhythmia Institute, St. David's Medical Center, 3000 N. IH-35, Suite 720, Austin, TX 78705, USA.

Aims: We evaluated the efficacy of an ablation strategy empirically targeting pulmonary veins (PVs) and posterior wall (PW) and the prevalence and clinical impact of extrapulmonary trigger inducibility and ablation in a large cohort of patients with persistent atrial fibrillation (PerAF).

Methods And Results: A total of 1803 PerAF patients were prospectively enrolled. All patients underwent pulmonary vein antrum isolation (PVAI) extended to the entire PW. A standardized protocol was performed to confirm persistent PVAI and elicit any triggers originating from non-PV sites. All non-PV triggers initiating sustained atrial tachyarrhythmias were ablated. Ablation of non-PV sites triggering non-sustained runs (<30 s) of atrial tachyarrhythmias or promoting frequent premature atrial complexes (≥10/min) was left to operator's discretion. Overall, 1319 (73.2%) patients had documented triggers from non-PV areas. After 17.4 ± 8.5 months of follow-up, the cumulative freedom from atrial tachyarrhythmias among patients without inducible non-PV triggers (n = 484) was 70.2%. Patients with ablation of induced non-PV triggers had a significantly higher arrhythmia control than those whose triggers were not ablated (67.9% vs. 39.4%, respectively; P < 0.001). After adjusting for clinically relevant variables, patients in whom non-PV triggers were documented but not ablated had an increased risk of arrhythmia relapse (hazard ratio: 2.39; 95% confidence interval: 2.01-2.83; P < 0.001).

Conclusion: Pulmonary vein antrum isolation extended to the entire PW might provide acceptable long-term arrhythmia-free survival in PerAF patients without inducible non-PV triggers. In our population of PerAF patients, non-PV triggers could be elicited in ∼70% of PerAF patients and their elimination significantly improved outcomes.
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http://dx.doi.org/10.1093/europace/euab161DOI Listing
August 2021

Intracardiac echocardiography- versus transesophageal echocardiography-guided left atrial appendage occlusion with Watchman FLX.

J Cardiovasc Electrophysiol 2021 10 5;32(10):2781-2784. Epub 2021 Sep 5.

Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas, USA.

Introduction: Watchman FLX has been recently approved for left atrial appendage occlusion (LAAO) in the US. Intracardiac echocardiography (ICE) - which is already commonly used to guide trans-septal access - can serve as an alternative to TEE, simplifying the procedure and reducing associated costs. Herein, we report our experience with ICE-guided LAAO with Watchman FLX.

Methods And Results: This cohort study included the first 190 consecutive patients who underwent LAAO with Watchman FLX in our center. LAAO was successful in all patients without significant peri-procedural, device-related complications in either group. Compared to TEE, we observed a significant reduction in procedural times when using ICE. In addition, there was a potentially clinically relevant reduction in fluoroscopy dose, mainly secondary to fewer cine acquisition runs. At follow-up, no cases of device embolism were noted, whereas the rate of device-related thrombosis and peri-device leaks were comparable between groups.

Conclusion: ICE-guided LAAO with Watchman FLX is safe and feasible, with a significant reduction in procedural time and potential reduction in fluoroscopy dose when compared to TEE.
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http://dx.doi.org/10.1111/jce.15220DOI Listing
October 2021

Decreased biventricular pacing with high burden PVCs, what is the cause?

J Cardiovasc Electrophysiol 2021 10 21;32(10):2755-2760. Epub 2021 Aug 21.

Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas, USA.

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http://dx.doi.org/10.1111/jce.15211DOI Listing
October 2021

Safety/Efficacy of DOAC Versus Aspirin for Reduction of Risk of Cerebrovascular Events Following VT Ablation.

JACC Clin Electrophysiol 2021 Jul 29. Epub 2021 Jul 29.

Texas Cardiac Arrhythmia Institute at St. David's Medical Center, Austin, Texas, USA.

Objectives: The STROKE-VT (Safety and Efficacy of Direct Oral Anticoagulant Versus Aspirin for Reduction of Risk of Cerebrovascular Events in Patients Undergoing Ventricular Tachycardia Ablation) study is a multicenter, randomized controlled trial that examined the differences in cerebrovascular events between direct oral anticoagulant (DOAC) and aspirin (ASA) use postprocedurally in patients who underwent left ventricular arrhythmia (LVA) ablation (ventricular tachycardia [VT] or premature ventricular contraction [PVC]) using radiofrequency ablation (RFA).

Background: There exists limited data regarding antiplatelet or anticoagulation strategy following LVA ablation.

Methods: A total of 246 patients scheduled for LVA-RFA were randomized 1:1 postprocedurally to receive DOACs or ASA. The study's primary endpoint was the incidence of stroke or transient ischemic attack (TIA) or asymptomatic cerebrovascular events (ACEs) detected by magnetic resonance imaging at 24 hours and 30 days of follow-up. The secondary endpoints included procedure-related complications (composite of any vascular complication, pericardial complication, heart block, and thromboembolic event, excluding stroke or TIA) and in-hospital mortality.

Results: There were no differences between groups regarding baseline and ablation characteristics (except the percentage of patients who underwent VT ablation, rate of amiodarone use, and total RFA time). Postprocedure cerebrovascular events (stroke and TIA) were lower in the DOAC arm versus the ASA arm (0% vs. 6.5%; P < 0.001 and 4.9% vs. 18%; P < 0.001, respectively). Patients in the ASA group had more MRI-detected ACEs compared with the DOAC group both at 24-hour (23% vs 12%; P = 0.03) and 30-day (18% vs. 6.5%; P = 0.006) follow-up. Acute procedure-related complications and in-hospital mortality were similar between the two groups.

Conclusions: DOAC use following endocardial and/or epicardial ablation for LVA-RFA was associated with reduced risk of TIA or stroke and asymptomatic MRI-detected cerebrovascular events.
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http://dx.doi.org/10.1016/j.jacep.2021.07.010DOI Listing
July 2021

Implantable cardioverter-defibrillator in patients with spontaneous coronary artery dissection presenting with sudden cardiac arrest.

J Cardiovasc Electrophysiol 2021 09 15;32(9):2595-2600. Epub 2021 Aug 15.

Cardiac Arrhythmia Service, Kansas City Heart Rhythm Institute and Research Foundation, Kansas City, Kansas, USA.

Introduction: The role of secondary prevention implantable cardioverter-defibrillator (ICD) remains uncertain in spontaneous coronary artery dissection (SCAD) patients presenting with sudden cardiac arrest (SCA).

Methods: We aimed at assessing the outcomes following SCA and the role of ICD therapy in SCAD. The meta-analysis was performed using a meta-package for R version 4.0/RStudio version 1.2 and the Freeman-Tukey double arcsine method to establish the variance of raw proportions. Outcomes measured included-(1) incidence of ICD implantation, (2) appropriate and inappropriate ICD therapy, (3) recurrence of SCAD and SCA, and (4) all-cause mortality.

Results: Five studies, including 139 SCAD patients with SCA met study inclusion criteria. The mean age was 47.3 ± 12.8 years, mean left ventricular ejection fraction 43.8 ± 10.8%, 88% were female (12% had pregnancy-associated SCAD. Causes of SCA included ventricular arrhythmia (97.9%, n = 136) and pulseless electrical activity (2.1%, n = 3). Overall, 20% patients (95% confidence interval [CI]: 7.1%-36.6%, I = 68%) received ICD, of which 1.2% (95% CI: 0%-15.8%, I = 0%) and 1% (95% CI: 0%-15.3%, I = 0%) patients received appropriate and inappropriate ICD therapies, respectively, during follow-up period (4.1 ± 3.3 years). Incidence of recurrent SCAD was 9% (95% CI: 2.85%-17.5%, I = 25%), and recurrent SCA was 3.85% patients (95% CI: 0.65%-8.7%, I = 0%; one patient with appropriate ICD therapy). The pooled incidence of all-cause mortality was 6.2% (95% CI: 0.6%-15.1%, I = 44%).

Conclusion: Although ICD therapy is beneficial in patients (all comers) presenting with cardiac arrest; the risk-benefit ratio of secondary prevention ICD arrest remains unclear. Patient-centered shared decision-making and risk-benefit ratio assessment should be performed before consideration for ICD implantation.
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http://dx.doi.org/10.1111/jce.15201DOI Listing
September 2021

Sinus Node Sparing Hybrid Thoracoscopic Ablation Outcomes in Patients with Inappropriate Sinus Tachycardia (SUSRUTA-IST) Registry.

Heart Rhythm 2021 Jul 30. Epub 2021 Jul 30.

Kansas City Heart Rhythm Institute, Overland Park, Kansas.

Background: Medical treatment of inappropriate sinus tachycardia (IST) remains suboptimal. Radiofrequency sinus node (RF-SN) ablation has poor success and higher complication rates.

Objective: We aimed to compare clinical outcomes of the novel SN sparing hybrid ablation technique with those of RF-SN modification for IST management.

Methods: This is a multicenter prospective registry comparing the SN sparing hybrid ablation strategy with RF-SN modification. The hybrid procedure was performed using an RF bipolar clamp, isolating superior vena cava/inferior vena cava with the creation of a lateral line across the crista terminalis while sparing the SN region (identified by endocardial 3-dimensional mapping). RF-SN modification was performed by endocardial and/or epicardial mapping and ablation at the site of earliest atrial activation.

Results: Of the 100 patients (hybrid ablation group, n = 50; RF-SN group, n = 50), 82% were women, and the mean age was 22.8 years. Normal sinus rhythm and rate were restored in all patients in the hybrid group (vs 84% in the RF-SN group; P = .006). Hybrid ablation was associated with significantly better improvement in mean daily heart rate and peak 6-minute walk heart rate compared with RF-SN ablation. The RF-SN group had a significantly higher rate of redo procedures (100% vs 8%; P < .001), phrenic nerve injury (14% vs 0%; P = .012), lower acute pericarditis (48% vs 92%; P < .0001), permanent pacemaker implantation (50% vs 4%; P < .0001) than did the hybrid ablation group.

Conclusion: The novel sinus node sparing hybrid ablation procedure appears to be more efficacious and safer in patients with symptomatic drug-resistant IST with long-term durability than RF-SN ablation.
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http://dx.doi.org/10.1016/j.hrthm.2021.07.010DOI Listing
July 2021

Radiofrequency Energy Applications Targeting Significant Residual Leaks After Watchman Implantation: A Prospective, Multicenter Experience.

JACC Clin Electrophysiol 2021 Jul 19. Epub 2021 Jul 19.

Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas, USA; Interventional Electrophysiology, Scripps Clinic, La Jolla, California, USA; Department of Cardiology, MetroHealth Medical Center, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.

Objectives: The aim of this study was to evaluate the efficacy of radiofrequency (RF) energy applications targeting the atrial side of a significant residual leak in patients with acute and chronic evidence of incomplete percutaneous left atrial appendage (LAA) occlusion.

Background: RF applications have been proved to prevent recanalization of intracranial aneurysms after coil embolization, thereby favoring complete sealing. From a mechanistic standpoint, in vitro and in vivo experiments have demonstrated that RF promotes collagen deposition and tissue retraction.

Methods: Forty-three patients (mean age 75 ± 7 years mean CHADS-VASc score 4.6 ± 1.4, mean HAS-BLED score 4.0 ± 1.1) with residual leaks ≥4 mm after Watchman implantation were enrolled. Procedural success was defined as complete LAA occlusion or presence of a mild or minimal (1- to 2-mm) peridevice leak on follow-up transesophageal echocardiography (TEE), which was performed approximately 45 days after the procedure.

Results: RF-based leak closure was performed acutely after Watchman implantation in 19 patients (44.2%) or scheduled after evidence of significant leaks on follow-up TEE in 24 others (55.8%). The median leak size was 5 mm (range: 4-7 mm). On average, 18 ± 7 RF applications per patient (mean maximum contact force 16 ± 3 g, mean power 44 ± 2 W, mean RF time 5.1 ± 2.5 minutes) were performed targeting the atrial edge of the leak. Post-RF median leak size was 0 mm (range: 0-1 mm). A very low rate (2.3% [n = 1]) of major periprocedural complications was observed. Follow-up TEE revealed complete LAA sealing in 23 patients (53.5%) and negligible residual leaks in 15 (34.9%).

Conclusions: RF applications targeting the atrial edge of a significant peri-Watchman leak may promote LAA sealing via tissue remodeling, without increasing complications. (RF Applications for Residual LAA Leaks [REACT]; NCT04726943).
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http://dx.doi.org/10.1016/j.jacep.2021.06.002DOI Listing
July 2021

Left Atrial Appendage Occlusion With New Watchman-FLX Device.

Am J Cardiol 2021 09 27;154:135-137. Epub 2021 Jul 27.

Cardiac Arrhythmia Service, Kansas City Heart Rhythm Institute and Research Foundation, Kansas City, Kansas.

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http://dx.doi.org/10.1016/j.amjcard.2021.04.001DOI Listing
September 2021

Device-Based Arrhythmia Monitoring.

Card Electrophysiol Clin 2021 09;13(3):xiii

Texas Cardiac Arrhythmia Institute, Center for Atrial Fibrillation at St. David's Medical Center, 1015 East 32nd Street, Suite 516, Austin, TX 78705, USA. Electronic address:

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http://dx.doi.org/10.1016/j.ccep.2021.06.002DOI Listing
September 2021

The Subtle Journey of a Right Atrial Lead: Hemopneumothorax Due to Subacute Pacemaker Lead Perforation.

JACC Case Rep 2020 Jun 17;2(6):902-906. Epub 2020 Jun 17.

Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas.

We report an unusual case of subacute right atrial perforation by a screw-in pacemaker lead that migrated into the right lung causing hemopneumothorax 2 weeks after the procedure. After transvenous simple manual traction and minithoracotomy repair of the right atrial wall, the lead was repositioned without any complications. ().
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http://dx.doi.org/10.1016/j.jaccas.2020.05.018DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8302113PMC
June 2020

Clinical presentation, diagnosis, and treatment of atrioesophageal fistula resulting from atrial fibrillation ablation.

J Cardiovasc Electrophysiol 2021 09 27;32(9):2441-2450. Epub 2021 Jul 27.

Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas, USA.

Background: Atrioesophageal fistula (AEF) is a worrisome complication of atrial fibrillation (AF) ablation. Its clinical manifestations and time course are unpredictable and may contribute to diagnostic and treatment delays. We conducted a systematic review of all available cases of AEF, aiming at characterizing clinical presentation, time course, diagnostic pitfalls, and outcomes.

Methods: The digital search retrieved 150 studies containing 257 cases, 238 (92.6%) of which with a confirmed diagnosis of AEF and 19 (7.4%) of pericardioesophageal fistula.

Results: The median time from ablation to symptom onset was 21 days (interquartile range [IQR]: 11-28). Neurological abnormalities were documented in 75% of patients. Compared to patients seen by a specialist, those evaluated at a walk-in clinic or community hospital had a significantly greater delay between symptom onset and hospital admission (median: 2.5 day [IQR: 1-8] vs. 1 day [IQR: 1-5); p = .03). Overall, 198 patients underwent a chest scan (computed tomography [CT]: 192 patients and magnetic resonance imaging [MRI]: 6 patients), 48 (24.2%; 46 CT and 2 MRI) of whom had normal/unremarkable findings. Time from hospital admission to diagnostic confirmation was significantly longer in patients with a first normal/unremarkable chest scan (p < .001). Overall mortality rate was 59.3% and 26.0% survivors had residual neurological deficits at the time of discharge.

Conclusions: Since healthcare professionals of any specialty might be involved in treating AEF patients, awareness of the clinical manifestations, diagnostic pitfalls, and time course, as well as an early contact with the treating electrophysiologist for a coordinated interdisciplinary medical effort, are pivotal to prevent diagnostic delays and reduce mortality.
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http://dx.doi.org/10.1111/jce.15168DOI Listing
September 2021

Safety and Feasibility of Peri-device Leakage Closure after LAAO: An International, Multi-center Collaborative Study.

EuroIntervention 2021 07 6. Epub 2021 Jul 6.

Cardiovascular Center (CVC) Frankfurt, Frankfurt, Germany.

Background: Residual peri-device leakage (PDL) is frequent after left atrial appendage occlusion (LAAO). Little is known about management strategies, procedural aspects and outcomes of interventional PDL closure.

Aims: To assess safety and feasibility of PDL closure after LAAO.

Methods: Fifteen centers contributed data on baseline characteristics, in-hospital and follow-up outcomes of patients who underwent PDL closure after LAAO. Outcomes of interest included acute success and complication rates and long-term efficacy of the procedure.

Results: A total of 95 patients were included and a cumulative number of 104 leaks were closed. Majority of PDL were detected within 90 days [range 41-231]. Detachable coils were the most frequent approach (42.3%), followed by the use of Amplatzer™Vascular Plug II (Abbott, Chicago, IL, 29.8%) and the Amplatzer™ Duct Occluder II (Abbott, Chicago, IL, 17.3%). Technical success was 100% with 94.2% of devices placed successfully within the first attempt. There were no major complications requiring surgical or transcatheter interventions. During follow-up (96 days [range 49-526]), persistent leaks were found in 18 patients (18.9%), yielding a functional success rate of 82.7%, although PDLs were significantly reduced in size (pre-leak sizemax: 6.1±3.6 mm vs. post-leak sizemax: 2.5±1.3 mm, p<0.001). None of the patient had a leak >5mm. Major adverse events during follow-up occurred in 5 patients (2 ischemic strokes, 2 intracranial hemorrhages, and 1 major gastrointestinal bleeding).

Conclusions: Several interventional techniques have become available to achieve PDL closure. They are associated with high technical and functional success and low complication rates.
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http://dx.doi.org/10.4244/EIJ-D-21-00286DOI Listing
July 2021

Incidence of Device-Related Thrombosis in Watchman Patients Undergoing a Genotype-Guided Antithrombotic Strategy.

JACC Clin Electrophysiol 2021 Jun 23. Epub 2021 Jun 23.

Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas, USA; Interventional Electrophysiology, Scripps Clinic, La Jolla, California, USA; Department of Cardiology, MetroHealth Medical Center, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.

Objectives: This study sought to report the incidence of device-related thrombosis (DRT) and thromboembolic (TE) events when an alternative to clopidogrel is prescribed in loss-of-function (LOF) allele carriers of the cytochrome P450 2C19 (CYP2C19) gene.

Background: LOF polymorphisms of the CYP2C19 gene are associated with reduced hepatic bioactivation of clopidogrel.

Methods: One thousand two Watchman patients were included. Six hundred forty-five patients underwent CYP2C19 genetic testing; among patients with clopidogrel resistance, clopidogrel was replaced by either prasugrel (pilot cohort) or half dose direct oral anticoagulant ((DOAC)/Group 1), both in combination with aspirin. We compared the incidence of DRT/TE events among genotyped patients and a control group which received standard dual antiplatelet therapy (DAPT) (Group 2; n = 357). All reported events occurred during a timeframe between 45- and 180-day follow-up transesophageal echocardiograms, when the 2 different antithrombotic strategies (genotype-guided vs standard DAPT) were adopted.

Results: In the pilot cohort (n = 244), bleeding events occurred in 10.2% of patients who received aspirin plus prasugrel, leading to early discontinuation of the prasugrel-based protocol. DOAC Group 1 patients (n = 401), 25.7% were reduced metabolizers, and clopidogrel was replaced by half dose direct oral anticoagulant. DRT was documented in 1 (0.2%) patient of Group 1 and 7 (1.96%) patients of Group 2 (log-rank P value = 0.021). The composite endpoint of DRT/TE events was significantly lower among patients receiving a genotype-guided antithrombotic strategy (0.75% vs 3.1%; log-rank P value = 0.017).

Conclusions: In Watchman patients, a genotype-based antithrombotic strategy with aspirin plus half dose DOAC in reduced clopidogrel metabolizers was superior to standard DAPT with respect to DRT/TE events.
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http://dx.doi.org/10.1016/j.jacep.2021.04.012DOI Listing
June 2021

Amplatzer PFO Occluder for treatment of incomplete LAA closure with AtriClip.

J Cardiovasc Electrophysiol 2021 08 12;32(8):2340-2342. Epub 2021 Jul 12.

Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas, USA.

Herein, we describe the use of an Amplatzer PFO Occluder to treat incomplete LAA closure due to a malpositioned AtriClip.
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http://dx.doi.org/10.1111/jce.15137DOI Listing
August 2021

Laser-assisted lead extraction of a retained lead remnant in the femoral and iliac veins.

J Cardiovasc Electrophysiol 2021 08 2;32(8):2337-2339. Epub 2021 Jul 2.

Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas, USA.

Herein, we present a case of laser-assisted extraction of a retained lead remnant following incomplete removal of an implantable cardiac defibrillator system implanted via a left femoral approach.
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http://dx.doi.org/10.1111/jce.15134DOI Listing
August 2021

Managing Atrial Fibrillation in Patients With Heart Failure and Reduced Ejection Fraction: A Scientific Statement From the American Heart Association.

Circ Arrhythm Electrophysiol 2021 Jun 15;14(6):HAE0000000000000078. Epub 2021 Jun 15.

Atrial fibrillation and heart failure with reduced ejection fraction are increasing in prevalence worldwide. Atrial fibrillation can precipitate and can be a consequence of heart failure with reduced ejection fraction and cardiomyopathy. Atrial fibrillation and heart failure, when present together, are associated with worse outcomes. Together, these 2 conditions increase the risk of stroke, requiring oral anticoagulation in many or left atrial appendage closure in some. Medical management for rate and rhythm control of atrial fibrillation in heart failure remain hampered by variable success, intolerance, and adverse effects. In multiple randomized clinical trials in recent years, catheter ablation for atrial fibrillation in patients with heart failure and reduced ejection fraction has shown superiority in improving survival, quality of life, and ventricular function and reducing heart failure hospitalizations compared with antiarrhythmic drugs and rate control therapies. This has resulted in a paradigm shift in management toward nonpharmacological rhythm control of atrial fibrillation in heart failure with reduced ejection fraction. The primary objective of this American Heart Association scientific statement is to review the available evidence on the epidemiology and pathophysiology of atrial fibrillation in relation to heart failure and to provide guidance on the latest advances in pharmacological and nonpharmacological management of atrial fibrillation in patients with heart failure and reduced ejection fraction. The writing committee's consensus on the implications for clinical practice, gaps in knowledge, and directions for future research are highlighted.
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http://dx.doi.org/10.1161/HAE.0000000000000078DOI Listing
June 2021

Early Implantable Cardioverter-Defibrillator After Acute Myocardial Infarction.

Am J Cardiol 2021 08 6;152:170-172. Epub 2021 Jun 6.

Division of Cardiology, Cardiac Arrhythmia Service, Medical College of Wisconsin, Milwaukee, Wisconsin. Electronic address:

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http://dx.doi.org/10.1016/j.amjcard.2021.04.024DOI Listing
August 2021
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