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Long-term safety and effectiveness of paroxysmal atrial fibrillation ablation using a porous tip contact force-sensing catheter from the SMART SF trial

Natale, Andrea; Monir, George; Patel, Anshul M; Fishel, Robert S; Marchlinski, Francis E; Delaughter, M Craig; Athill, Charles A; Melby, Daniel P; Gonzalez, Mario D; Hariharan, Ramesh; Gidney, Brett; Tan, Tiffany; Chinitz, Larry A
PURPOSE/OBJECTIVE:The prospective, multicenter SMART SF trial demonstrated the acute safety and effectiveness of the 56-hole porous tip irrigated contact force (CF) catheter for drug-refractory paroxysmal atrial fibrillation (PAF) ablation with a low primary adverse event rate (2.5%), leading to FDA approval of the catheter. Here, we are reporting the long-term effectiveness and safety results that have not yet been reported. METHODS:Ablations were performed using the 56-hole porous tip irrigated CF catheter guided by the 3D mapping system stability module. The primary effectiveness endpoint was freedom from atrial tachyarrhythmia (including atrial fibrillation, atrial tachycardia, and/or atrial flutter), based on electrocardiographic data at 12 months. Atrial tachyarrhythmia recurrence occurring 3 months post procedure, acute procedural failures such as lack of entrance block confirmation of all PVs, and undergoing repeat procedure for atrial fibrillation in the evaluation period (91 to 365 days post the initial ablation procedure) were considered to be effectiveness failures. RESULTS:Seventy-eight patients (age 64.8 ± 9.7 years; male 52.6%; Caucasian 96.2%) participated in the 12-month effectiveness evaluation. Mean follow-up time was 373.5 ± 45.4 days. The Kaplan-Meier estimate of freedom from 12-month atrial tachyarrhythmia was 74.9%. Two procedure-related pericardial effusion events were reported at 92 and 180 days post procedure. There were no pulmonary vein stenosis complications or deaths reported through the 12-month follow-up period. CONCLUSIONS:The SMART SF 12-month follow-up evaluation corroborates the early safety and effectiveness success previously reported for PAF ablation with STSF.
PMID: 32462550
ISSN: 1572-8595
CID: 4451862

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

Reply: Electrical Weapons and Electrophysiology

Barbhaiya, Chirag R; Moskowitz, Craig; Duraiswami, Harish; Jankelson, Lior; Knotts, Robert J; Bernstein, Scott; Park, David; Holmes, Douglas; Aizer, Anthony; Chinitz, Larry A
PMCID:8299239
PMID: 34317106
ISSN: 2666-0849
CID: 4949432

Inappropriate ICD Shock as a Result of TASER Discharge [Case Report]

Barbhaiya, Chirag R; Moskowitz, Craig; Duraiswami, Harish; Jankelson, Lior; Knotts, Robert J; Bernstein, Scott; Park, David; Holmes, Douglas; Aizer, Anthony; Chinitz, Larry A
Conducted energy weapon (commonly known as TASER) discharge in patients with implantable cardioverter-defibrillators is known to cause electromagnetic interference and inappropriate ventricular fibrillation sensing without delivery of implantable cardioverter-defibrillators therapy during conducted energy weapon application. We report the first known case of conducted energy weapon discharge resulting in inappropriate implantable cardioverter-defibrillators therapy. (Level of Difficulty: Beginner.).
PMCID:8311712
PMID: 34317440
ISSN: 2666-0849
CID: 4949472

Multiple Procedure Outcomes for Non-Paroxysmal Atrial Fibrillation: Left Atrial Posterior Wall Isolation versus Stepwise Ablation

Barbhaiya, Chirag R; Knotts, Robert J; Beccarino, Nicholas; Vargas-Pelaez, Alvaro F; Jankelson, Lior; Bernstein, Scott; Park, David; Holmes, Douglas; Aizer, Anthony; Chinitz, Larry A
OBJECTIVE:To compare multiple-procedure catheter ablation outcomes of a stepwise approach versus left atrial posterior wall isolation (LA PWI) in patients undergoing non-paroxysmal atrial fibrillation (NPAF) ablation. BACKGROUND:Unfavorable outcomes for stepwise ablation of NPAF in large clinical trials may be attributable to pro-arrhythmic effects of incomplete ablation lines. It is unknown if a more extensive initial ablation strategy results in improved outcomes following multiple ablation procedures. METHODS:222 consecutive patients with NPAF underwent first-time ablation using a contact-force sensing ablation catheter utilizing either a stepwise (Group 1, n=111) or LA PWI (Group 2, n=111) approach. The duration of follow-up was 36 months. The primary endpoint was freedom from atrial arrhythmia >30s. Secondary endpoints were freedom from persistent arrhythmia, repeat ablation, and recurrent arrhythmia after repeat ablation. RESULTS:There was similar freedom from atrial arrhythmias after index ablation for both stepwise and LA PWI groups at 36 months (60% vs. 69%, p=0.1). The stepwise group was more likely to present with persistent recurrent arrhythmia (29% vs 14%, p=0.005) and more likely to undergo second catheter ablation (32% vs. 12%, p<0.001) compared to LA PWI patients. Recurrent arrhythmia after repeat ablation was more likely in the stepwise group compared to the LA PWI group (15% vs 4%, p=0.003). CONCLUSIONS:Compared to a stepwise approach, LA PWI for patients with NPAF resulted in a similar incidence of any atrial arrhythmia, lower incidence of persistent arrhythmia, and fewer repeat ablations. Results for repeat ablation were not improved with a more extensive initial approach. This article is protected by copyright. All rights reserved.
PMID: 33022816
ISSN: 1540-8167
CID: 4626822

Atrioventricular synchronous pacing in leadless ventricular pacemaker is safe and effective in patients with paroxysmal AV block and atrial arrhythmias [Meeting Abstract]

Garweg, C; Khelae, S K; Chan, J Y S; Chinitz, L; Ritter, P; Johansen, J B; Sagi, V; Epstein, L M; Piccini, J P; Pascual, M; Mont, L; Splett, V; Stromberg, K; Kristiansen, N; Steinwender, C
Background/Introduction Accelerometer (ACC)-based AV synchronous pacing by tracking atrial activity is feasible using a leadless ventricular pacemaker. Patients may experience variable AV conduction (AVC) and/or atrial arrhythmias during the lifetime of their device. ACC-based AV synchronous pacing should facilitate AVC and pace appropriately in those two common rhythms.
Purpose(s): To characterize the behavior of ACC-based AV synchronous pacing algorithms during paroxysmal AV block (AVB) and atrial arrhythmias.
Method(s): The MARVEL2 (Micra Atrial tRacking using a Ventricular accELerometer) was a 5-hour acute study to assess the efficacy of atrial tracking with a temporarily downloaded algorithm into a Micra leadless pacemaker. Patients with a history of AVB were eligible for inclusion. The MARVEL2 algorithm included a mode-switching algorithm that switched between VDD and VVI-40 depending upon AVC status. The AVC algorithm requires 2 ventricular paces (VP) at 40 bpm out of 4 pacing cycles to switch to VDD.
Result(s): Overall, 75 patients (age 77.5 +/- 11.8 years, 40% female, median time from Micra implant 9.7 months) from 12 centers worldwide were enrolled. During study procedures, 40 patients (53%) had normal sinus rhythm with complete AVB, 18 (24%) had 1:1 AVC, 5 (7%) had varying AVC status, 8 (11%) had atrial arrhythmias, and 2 other rhythms. Two patients with complete AVB had the AVC mode switch feature disabled due to an idioventricular rate >40 bpm. Among the 40 subjects with a predominant 3rd degree AVB and normal sinus function the median %VP was 99.9% compared to 0.2% among those with 1:1 AVC (Figure). In the patients with 1:1 AVC, there were 64 opportunities to AVC mode switch with 48 switching to VDI-40. In the other 16 cases (2 patients) the mode remained VDD due to sinus bradycardia varying between 40-45 bpm. High %VP was observed in 2 patients with 1:1 AVC and sinus bradycardia <40 bpm. The AVC mode switch minimized %VP (<1%) in patients with PR intervals > 300 ms (N = 2). Among patients with varying AVC, the algorithm appropriately switched to VDD when the ventricular rate was paced at 40 bpm. During infrequent AVB or AF with ventricular response >40 bpm, VVI-40 mode was maintained. In patients with AF, the ACC signal was of low amplitude and there was infrequent sensing, resulting in VP at the lower rate (50 bpm). In the one patient with atrial flutter, the ACC was intermittently detected, resulting in VP at 67 bpm (IQR 66-67 bpm). Conclusion(s) The mode switching algorithm in the MARVEL2 reduced %VP in patients with 1:1 AVC and appropriately switched to VDD during complete AVB. If greater AV synchrony or rate support is required, disabling the AVC algorithm may be appropriate for low grade AVB or idioventricu-lar rhythms. In the presence of atrial arrhythmias, the algorithm paced near the lower rate
EMBASE:632942617
ISSN: 1532-2092
CID: 4623842

Predictors of atrial mechanical sensing and atrioventricular synchrony with a leadless ventricular pacemaker: Results from the MARVEL 2 Study

Garweg, Christophe; Khelae, Surinder Kaur; Steinwender, Clemens; Chan, Joseph Yat Sun; Ritter, Philippe; Johansen, Jens Brock; Sagi, Venkata; Epstein, Laurence M; Piccini, Jonathan P; Pascual, Mario; Mont, Lluis; Willems, Rik; Sheldon, Todd; Splett, Vincent; Stromberg, Kurt; Wood, Nicole; Chinitz, Larry
BACKGROUND:The MARVEL (Micra Atrial TRacking Using a Ventricular AccELerometer) 2 study assessed the efficacy of atrioventricular (AV) synchronous pacing with a Micra leadless pacemaker. Average atrioventricular synchrony (AVS) was 89.2%. Previously, low amplitude of the Micra-sensed atrial signal (A4) was observed to be a factor of low AVS. OBJECTIVE:The purpose of this study was to identify predictors of A4 amplitude and high AVS. METHODS:We analyzed 64 patients enrolled in MARVEL 2 who had visible P waves on electrocardiogram for assessing A4 amplitude and 40 patients with third-degree AV block for assessing AVS at rest. High AVS was defined as >90% correct atrial-triggered ventricular pacing. The association between clinical factors and echocardiographic parameters with A4 amplitude was investigated using a multivariable model with lasso variable selection. Variables associated with A4 amplitude together with premature ventricular contraction burden, sinus rate, and sinus rate variability (standard deviation of successive differences of P-P intervals [SDSD]) were assessed for association with AVS. RESULTS:In univariate analysis, low A4 amplitude was inversely related to atrial function assessed by E/A ratio and e'/a' ratio, and was directly related to atrial contraction excursion (ACE) and atrial strain (Ɛa) on echocardiography (all P ≤.05). The multivariable lasso regression model found coronary artery bypass graft history, E/A ratio, ACE, and Ɛa were associated with low A4 amplitude. E/A ratio and SDSD were multivariable predictors of high AVS, with >90% probability if E/A <0.94 and SDSD <5 bpm. CONCLUSION/CONCLUSIONS:Clinical parameters and echocardiographic markers of atrial function are associated with A4 signal amplitude. High AVS can be predicted by E/A ratio <0.94 and low sinus rate variability at rest.
PMID: 32717315
ISSN: 1556-3871
CID: 4614252

Response to: Do not yet abandon cephalic vein access for multiple leads in ICD implantation [Letter]

Barbhaiya, Chirag R; Niazi, Osama; Jankelson, Lior; Bernstein, Scott; Park, David; Holmes, Douglas; Aizer, Anthony; Chinitz, Larry A
PMID: 32789905
ISSN: 1540-8167
CID: 4556572

The case for quinidine: Management of electrical storm in refractory ventricular fibrillation [Case Report]

Pinnelas, Rebecca; Friedman, Julie; Gidea, Claudia; Yuriditsky, Eugene; Chinitz, Larry; Cerrone, Marina; Jankelson, Lior
PMCID:7360984
PMID: 32695580
ISSN: 2214-0271
CID: 4532352

Comparison of the Effect of Atrial Fibrillation Detection Algorithms in Patients With Cryptogenic Stroke Using Implantable Loop Recorders

Chorin, Ehud; Peterson, Connor; Kogan, Edward; Barbhaiya, Chirag; Aizer, Anthony; Holmes, Douglas; Bernstein, Scott; Schole, Michael; Duraiswami, Harish; Spinelli, Michael; Park, David; Chinitz, Larry; Jankelson, Lior
Occult atrial fibrillation (AF) can be the underlying cause for cryptogenic stroke (CS). Implantable loop recorders (ILRs) have become an important tool for long-term arrhythmia monitoring in CS patients. Office-based ILR implantation by nonelectrophysiologist physicians is increasingly common. To report the real world diagnostic yield and accuracy of remote ILR monitoring in high risk CS patients, we retrospectively analyzed 145 consecutive patients with CS who underwent ILR implantation between October 2014 and October 2018 at New York University Langone Health. A certified device technician and an electrophysiologist adjudicated all transmissions. The yield and accuracy of Reveal LINQ Intra Cardiac Monitor (ICM), a fourth generation device, was compared to that of TruRhythm Detection algorithm (fifth generation device). AF was diagnosed in 17 patients (12%) over a mean follow-up of 28 ± 12 months. The median time to diagnosis was 7.4 ± 21.3 months. A total of 1,637 remote transmissions (scheduled- and auto-triggered alerts: 756; patient-triggered: 881) were adjudicated. The positive predictive value for AF episodes in the scheduled interrogations increased from 4% in the Reveal LINQ ICM to 16% in the TruRhythm LINQ. Of 881 patient-triggered transmissions, none were found to be true positive. In the Reveal LINQ ICM, for scheduled transmissions, primary causes of false positive (FP) were atrial ventricular premature complexes (80%). In the TruRhythm LINQ, for scheduled transmissions, primary cause of FP were T-wave over-sensing (87%). In conclusion, the real world diagnostic yield of ILR for patients with CS remains suboptimal, with at least 84% of AF alerts being FP. Patient-riggered events did not correlate with arrhythmia and the necessity of patient triggering in this population should be questioned. Expert interpretation of recordings is critical to assure accurate diagnosis.
PMID: 32600783
ISSN: 1879-1913
CID: 4504002