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Early ICD Lead Failure in Defibrillator Systems with Multiple Leads Via Cephalic Access

Barbhaiya, Chirag R; Niazi, Osama; Bostrom, Jack; Patil, Sachi; Jankelson, Lior; Bernstein, Scott; Park, David; Holmes, Douglas; Aizer, Anthony; Chinitz, Larry A
INTRODUCTION/BACKGROUND:Implantable cardioverter defibrillators (ICDs) are proven to prevent sudden death in patients at elevated risk for sustained ventricular tachycardia or fibrillation. Complications related to ICD failure can stem from lead dysfunction, manufacturing defects, patient characteristics or implantation technique. We conducted a review of all ICD leads implanted at our center from 2011-2017 to determine risk factors for premature lead failure. METHODS:We conducted a retrospective review of patients of all ICD leads implanted from December 2011 to June 2017 at our institution. A total of 660 patients (Biotronik Linox S/SD, n = 281; Sprint Quatro, n = 207; Durata, n = 121; Endotak, n = 51) underwent ICD implantations. Patient and lead characteristics, procedural outcomes and complications were recorded. Lead failure was defined per Heart Rhythm Society lead-management consensus as a lack of procedural or clinical success, thus requiring an extraction of the lead. Patient and lead outcomes were recorded and variables associated with lead failure were assessed by the Kaplan-Meier method. RESULTS:Overall failure rate was similar for all leads: Linox S/SD - 0.29%/year; Sprint Quattro - 0.21%/year, Durata - 0.39%/year and Endotak Reliance - 0.0% (p=0.769). No difference was found in overall survival when comparing all ICD manufacturers during the study period. Subgroup analysis revealed the risk of premature lead failure was particularly pronounced in multi-lead ICD systems implanted via cephalic access (p<0.001). The estimated failure rate of Linox leads implanted via cephalic access in multi-lead systems was 19%/year. The estimated failure rate of non-Linox leads implanted via cephalic access in multi-lead systems was 11%/year. Neither age, nor gender were risk factors for lead failure in the Linox, or non-Linox cohorts. CONCLUSION/CONCLUSIONS:All analyzed ICD leads were found to have a similar overall risk of premature failure. ICD lead implantation via cephalic access in multilead ICD systems may be a previously unidentified risk factor for premature ICD lead failure, although these findings require further validation. This article is protected by copyright. All rights reserved.
PMID: 32356380
ISSN: 1540-8167
CID: 4412892

Esophageal Temperature Dynamics During High Power Short Duration Posterior Wall Ablation

Barbhaiya, Chirag R; Kogan, Edward V; Jankelson, Lior; Knotts, Robert J; Spinelli, Michael; Bernstein, Scott; Park, David; Aizer, Anthony; Chinitz, Larry A; Holmes, Douglas
BACKGROUND:Increased peak luminal esophageal temperature (LET) is associated with increased risk of esophageal injury following left atrial posterior wall (LAPW) ablation. The magnitude, distribution, and risk factors of LET increase with high power short duration (HPSD) LAPW ablation are not well understood. OBJECTIVE:We aimed to describe the spatial and temporal characteristics of LET changes associated with HPSD LAPW RFA. METHODS:LET was sampled at 20Hz using a 12-point esophageal temperature monitor (CIRCA S-CATH, Circa Scientific, Inc.) in 16 patients undergoing LAPW ablation. Esophageal temperature sensor position and lesion locations were recorded using an electroanatomic mapping system with fluoroscopic integration (CARTO 3, CARTOUNIVU, Biosense Webster, Inc). Point-by-point LAPW ablation was performed at 50W for 6s. The first 20 LAPW lesions were individually analyzed in each patient. RESULTS:LET increase ≥4°C (8 lesions: Max LET 5.8°C), 2-4°C (34 lesions), and 1-2°C (58 lesions) occurred at 9±2 mm, 8±2 mm, and 13±2mm from sensors, respectively. Lesions placed >20mm from a temperature sensor did not result in an LET increase ≥2°C. Temperature resolution to within 1°C of baseline occurred at ∼60s after cessation of RF. Consecutive lesions resulting in additive heating of at least 1°C occurred in 17 lesion pairs with an inter-lesion distance of 9±4mm and inter-lesion time of 21±4s. CONCLUSION/CONCLUSIONS:HPSD LAPW ablation can result in severe esophageal temperature increases. Significant LET increase will be undetected when lesions are >20mm away from a temperature sensor. Additive LET increase was observed with consecutive lesions placed less than 20mm apart within 60s.
PMID: 31978595
ISSN: 1556-3871
CID: 4273622

Pseudopolymorphic Wide Complex Tachycardia in a Child With Long QT Syndrome [Case Report]

Cerrone, Marina; Magnani, Silvia; Borneman, Linda; Cecchin, Frank; Tan, Reina; Fowler, Steven J; Chinitz, Larry; Jankelson, Lior
Implantable loop recorders (ILRs) can be a valuable tool in monitoring patients with inherited arrhythmia. This paper reports on a family with long QT syndrome (type 2 [LQT2]) in which a pseudopolymorphic wide complex tachycardia detected by ILR was ultimately diagnosed as a supraventricular aberrant rhythm, facilitated by noncompliance with beta-blocker therapy. (Level of Difficulty: Intermediate.).
PMCID:8298547
PMID: 34317300
ISSN: 2666-0849
CID: 4949452

Deep learning models for electrocardiograms are susceptible to adversarial attack

Han, Xintian; Hu, Yuxuan; Foschini, Luca; Chinitz, Larry; Jankelson, Lior; Ranganath, Rajesh
Electrocardiogram (ECG) acquisition is increasingly widespread in medical and commercial devices, necessitating the development of automated interpretation strategies. Recently, deep neural networks have been used to automatically analyze ECG tracings and outperform physicians in detecting certain rhythm irregularities1. However, deep learning classifiers are susceptible to adversarial examples, which are created from raw data to fool the classifier such that it assigns the example to the wrong class, but which are undetectable to the human eye2,3. Adversarial examples have also been created for medical-related tasks4,5. However, traditional attack methods to create adversarial examples do not extend directly to ECG signals, as such methods introduce square-wave artefacts that are not physiologically plausible. Here we develop a method to construct smoothed adversarial examples for ECG tracings that are invisible to human expert evaluation and show that a deep learning model for arrhythmia detection from single-lead ECG6 is vulnerable to this type of attack. Moreover, we provide a general technique for collating and perturbing known adversarial examples to create multiple new ones. The susceptibility of deep learning ECG algorithms to adversarial misclassification implies that care should be taken when evaluating these models on ECGs that may have been altered, particularly when incentives for causing misclassification exist.
PMID: 32152582
ISSN: 1546-170x
CID: 4349692

The renal transport of hippurate and protein-bound solutes

Kumar, Rohit; Adiga, Avinash; Novack, Joshua; Etinger, Alex; Chinitz, Lawrence; Slater, James; de Loor, Henriette; Meijers, Bjorn; Holzman, Robert S; Lowenstein, Jerome
Measurement of the concentration of hippurate in the inferior vena cava and renal blood samples performed in 13 subjects with normal or near-normal serum creatinine concentrations confirmed the prediction that endogenous hippurate was cleared on a single pass through the kidney with the same avidity as that reported for infused para-amino hippurate. This suggests that a timed urine collection without infusion would provide a measure of effective renal plasma flow. Comparison of the arteriovenous concentration differences for a panel of protein-bound solutes identified solutes that were secreted by the renal tubule and solutes that were subjected to tubular reabsorption.
PMCID:7041931
PMID: 32097533
ISSN: 2051-817x
CID: 4324292

Atrioventricular synchronous pacing using a leadless ventricular pacemaker: Results from the MARVEL 2 study

Steinwender, Clemens; Khelae, Surinder Kaur; Garweg, Christophe; Sun Chan, Joseph Yat; Ritter, Philippe; Johansen, Jens Brock; Sagi, Venkata; Epstein, Laurence M; Piccini, Jonathan P; Pascual, Mario; Mont, Lluis; Sheldon, Todd; Splett, Vincent; Stromberg, Kurt; Wood, Nicole; Chinitz, Larry
OBJECTIVES/OBJECTIVE:We report performance of a leadless ventricular pacemaker with automated, enhanced accelerometer-based algorithms to provide atrioventricular (AV) synchronous pacing. BACKGROUND:Despite many advantages, leadless pacemakers are currently only capable of single-chamber ventricular pacing. METHODS:The prospective Micra Atrial tRacking using a Ventricular accELerometer (MARVEL) 2 study assessed the performance of an automated, enhanced accelerometer-based algorithm downloaded for up to 5 hours in patients with AV block implanted with a Micra leadless pacemaker. The primary efficacy objective was to demonstrate the superiority of the algorithm to provide AV synchronous (VDD) pacing versus VVI-50 pacing in patients with sinus rhythm and complete AV block. The primary safety objective was to demonstrate that the algorithm did not result in pauses or heart rates >100 bpm. RESULTS:Overall, 75 patients from 12 centers were enrolled and received a software download of the accelerometer-based algorithm to their leadless pacemakers. Among the 40 patients with sinus rhythm and complete AV block included in the primary efficacy objective analysis, the percentage of patients with ≥70% AV synchrony at rest was significantly greater with VDD pacing than with VVI pacing (95% vs. 0%, P<0.001). The mean %AV synchrony increased from 26.8% (median 26.9%) during VVI pacing to 89.2% (median 94.3%) during VDD pacing. There were no pauses or episodes of pacing-induced tachycardia reported during VDD pacing in all 75 patients. CONCLUSION/CONCLUSIONS:Accelerometer-based atrial sensing with an automated, enhanced algorithm significantly improved AV synchrony in patients with sinus rhythm and AV block implanted with a leadless ventricular pacemaker.
PMID: 31709982
ISSN: 2405-5018
CID: 4186752

Quantitative analysis of ablation technique predicts arrhythmia recurrence following atrial fibrillation ablation

Jankelson, Lior; Dai, Matthew; Bernstein, Scott; Park, David; Holmes, Douglas; Aizer, Anthony; Chinitz, Larry; Barbhaiya, Chirag
BACKGROUND:Optimal ablation technique, including catheter-tissue contact during atrial fibrillation (AF) radiofrequency (RF) ablation, is associated with improved procedural outcomes. We used a custom developed software to analyze high-frequency catheter position data to study the interaction between catheter excursion during lesion placement, lesion-set sequentiality, and arrhythmia recurrence. METHODS:A total of 100 consecutive patients undergoing first-time RF ablation for paroxysmal AF were analyzed. Spatial positioning of the ablation catheter sampled at 60 Hz during RF application was extracted from the CARTO3 system (Biosense Webster Inc, USA) and analyzed using custom-developed MATLAB software to determine precise catheter spatial 3D excursion during RF ablation. The primary end point was freedom from atrial arrhythmia lasting longer than 30 seconds after a single ablation procedure. RESULTS:At 1 year, 86% of patients were free from recurrent arrhythmia. There was no significant difference in clinical, echocardiographic, or ablation characteristics between patients with and without recurrent arrhythmia. Analyzing 15,356,998 position data points revealed that lesion-set sequentiality and mean lesion catheter excursion were predictors of arrhythmia recurrence. Analyzing arrhythmia recurrence by mean single-lesion catheter excursion (excursion >2.81 mm) and by sequentiality (using 46% of lesions with interlesion distance >6 mm as cutoff) revealed significantly increased arrhythmia recurrence in the higher excursion group (23% vs 6%, P = .03) and in the less sequential group (24% vs 4%, P = .02). CONCLUSIONS:Ablation lesion sequentiality measured by catheter interlesion distance and catheter stability measured by catheter excursion during lesion placement are potentially modifiable factors affecting arrhythmia recurrence after RF ablation for AF.
PMID: 31835167
ISSN: 1097-6744
CID: 4235072

Patient selection, pacing indications, and subsequent outcomes with de novo leadless single-chamber VVI pacing

Piccini, Jonathan P; Stromberg, Kurt; Jackson, Kevin P; Kowal, Robert C; Duray, Gabor Z; El-Chami, Mikhael F; Crossley, George H; Hummel, John D; Narasimhan, Calambur; Omar, Razali; Ritter, Philippe; Roberts, Paul R; Soejima, Kyoko; Reynolds, Dwight; Zhang, Shu; Steinwender, Clemens; Chinitz, Larry
AIMS/OBJECTIVE:Patient selection is a key component of securing optimal patient outcomes with leadless pacing. We sought to describe and compare patient characteristics and outcomes of Micra patients with and without a primary pacing indication associated with atrial fibrillation (AF) in the Micra IDE trial. METHODS AND RESULTS/RESULTS:The primary outcome (risk of cardiac failure, pacemaker syndrome, or syncope related to the Micra system or procedure) was compared between successfully implanted patients from the Micra IDE trial with a primary pacing indication associated with AF or history of AF (AF group) and those without (non-AF group). Among 720 patients successfully implanted with Micra, 228 (31.7%) were in the non-AF group. Reasons for selecting VVI pacing in non-AF patients included an expectation for infrequent pacing (66.2%) and advanced age (27.2%). More patients in the non-AF group had a condition that precluded the use of a transvenous pacemaker (9.6% vs. 4.7%, P = 0.013). Atrial fibrillation patients programmed to VVI received significantly more ventricular pacing compared to non-AF patients (median 67.8% vs. 12.6%; P < 0.001). The overall occurrence of the composite outcome at 24 months was 1.8% with no difference between the AF and non-AF groups (hazard ratio 1.36, 95% confidence interval 0.45-4.2; P = 0.59). CONCLUSION/CONCLUSIONS:Nearly one-third of patients selected to receive Micra VVI therapy were for indications not associated with AF. Non-AF VVI patients required less frequent pacing compared to patients with AF. Risks associated with VVI therapy were low and did not differ in those with and without AF.
PMID: 31681964
ISSN: 1532-2092
CID: 4222872

Multimodality Imaging of Danon Disease in a Patient with a Novel LAMP2 Mutation [Case Report]

McLeod, Jennifer M; Fowler, Steven J; Cerrone, Marina; Aizer, Anthony; Chinitz, Larry A; Raad, Roy; Saric, Muhamed
PMCID:6833129
PMID: 31709377
ISSN: 2468-6441
CID: 4184922

Factors predicting persistence of AV nodal block in post-TAVR patients following permanent pacemaker implantation

Lader, Joshua M; Barbhaiya, Chirag R; Subnani, Kishore; Park, David; Aizer, Anthony; Holmes, Douglas; Staniloae, Cezar; Williams, Mathew R; Chinitz, Larry A
INTRODUCTION/BACKGROUND:A common complication of TAVR is development of conduction defects requiring pacemaker (PPM) implantation. These defects are not universally permanent. OBJECTIVE:To determine the incidence and predictors of persistent device dependency in patients with PPM implantation following TAVR with a self-expanding prosthesis. METHODS:Records of patients who underwent post-TAVR PPM implantation were reviewed. Patients with persistent complete AV block (AVBIII) one month post-TAVR were compared to those regaining conduction. RESULTS:Between September 2014 and March 2017, 485 patients underwent TAVR with a self-expanding prosthesis; 77 (15.9%) underwent PPM implantation for AVBIII. Device interrogation at one month was available for 61 patients (79%): 22 (36.1%) had resolution of AVBIII while 39 (63.9%) remained pacemaker-dependent. Pre-TAVR RBBB was more frequent in device-dependent patients (19 of 38, 50% vs 4 of 22, 18%; RR 2.75; p = 0.01). Device-dependence was associated with AVBIII as the first post-procedural rhythm (37 of 39, 95% vs 12 of 22, 55%; RR 1.74; p<0.0001), earlier implantation (median 1d, IQR: 0-1.5d vs 2d, IQR: 1.0-4.0d, p = 0.0004), and a shorter duration of hospitalization (median 3d, IQR: 2-3.5d vs 4d, IQR: 2-5.75d, p = 0.03). Pacemaker dependence was also associated with a higher prosthesis-to-LVOT diameter (1.45±0.11 vs 1.39±0.07; p = 0.02) and the lack of prior aortic valvuloplasty (5 of 39, 13% vs 8 of 22, 36%; RR 0.35; p = 0.03). CONCLUSIONS:In patients receiving a PPM following self-expanding TAVR, a long-term pacing requirement can be predicted from the timing of AV block, existing conduction-system disease, larger prosthesis-to-LVOT diameter, and the lack of aortic valvuloplasty. This article is protected by copyright. All rights reserved.
PMID: 31429947
ISSN: 1540-8159
CID: 4046752