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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

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

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

Photorealistic imaging of left atrial appendage occlusion/exclusion

Vainrib, Alan F; Bamira, Daniel; Aizer, Anthony; Chinitz, Larry A; Loulmet, Didier; Benenstein, Ricardo J; Saric, Muhamed
Recent improvements in 3D TEE post processing rendering techniques referred to as TrueVue (Philips Medical Systems, Andover, MA, USA). It allows for novel photorealistic imaging of cardiac structures including left atrial appendage (LAA) and its closure devices. Here we present TrueVue images of the LAA prior to and after LAA exclusion/occlusion using various percutaneous and surgical techniques. TrueVue may improve delineation of LAA anatomy prior to occlusion as well as visualization of occluder device position within the LAA.
PMID: 31385344
ISSN: 1540-8175
CID: 4033092

Impact of RNA testing on cardiac variant interpretation and patient management [Case Report]

Jankelson, Lior; Zimmermann, Heather; Fowler, Steven; Borneman, Linda; Conner, Blair; Wu, Sitao; Karam, Rachid; Chinitz, Larry; Cerrone, Marina
PMCID:6700669
PMID: 31453089
ISSN: 2214-0271
CID: 4054342

Left Atrial Occlusion Device Implantation: the Role of the Echocardiographer

Altszuler, David; Vainrib, Alan F; Bamira, Daniel G; Benenstein, Ricardo J; Aizer, Anthony; Chinitz, Larry A; Saric, Muhamed
PURPOSE OF REVIEW/OBJECTIVE:Atrial fibrillation is the most common arrhythmia worldwide and is a major risk factor for embolic stroke. For patients with atrial fibrillation who are unable to tolerate systemic anticoagulation, left atrial appendage (LAA) occlusion has been shown to mitigate stroke risk. In this article, we describe the vital role of the echocardiographer in intraprocedural guidance of percutaneous LAA occlusion procedures as well as in the pre- and post-procedure assessment of these patients. RECENT FINDINGS/RESULTS:A few percutaneously delivered devices for LAA exclusion from the systemic circulation are available in contemporary practice. These devices employ an either exclusive endocardial LAA occlusion approach, such as the Watchman (Boston Scientific, Maple Grove, MN) and Amulet (St. Jude Medical, Minneapolis, MN), or both an endocardial and pericardial (epicardial) approach such as the Lariat procedure (SentreHEART, Palo Alto, CA). Two- and three-dimension transesophageal echocardiography is critical for patient selection, procedure planning, procedural guidance, and ensuring satisfactory immediate as well as long-term LAA occlusion/exclusion efficacy. This review will provide an overview of the role of the echocardiographer in all aspects of LAA occlusion/exclusion procedures for the most commonly used commercially available devices in current practice.
PMID: 31183616
ISSN: 1534-3170
CID: 3929942

LONG-TERM ARRHYTHMIA RECURRENCE AFTER ATRIAL FIBRILLATION ABLATION IN HYPERTROPHIC CARDIOMYOPATHY [Meeting Abstract]

Jankelson, L; Kogan, E V; Barbhaiya, C R; Aizer, A; Holmes, D; Park, D S; Stepanovic, A; Cerrone, M; Sherrid, M; Chinitz, L A
Background: Despite the increased prevalence of atrial fibrillation (AF) in hypertrophic cardiomyopathy (HCM), the efficacy of radiofrequency ablation (RFA) has been characterized over limited follow-up intervals (~1 year). Several large meta-analyses note that patients with HCM have substantially higher rates of arrhythmia recurrence after RFA, compared to patients without HCM. The implication of confirmed HCM mutations on ablation efficacy has similarly only been assessed in small-scale studies.
Objective(s): To assess arrhythmia recurrence after RFA in patients with HCM and paroxysmal AF (PAAF) or persistent AF (PEAF) as well as its relation to their genetic background and LVOT gradient.
Method(s): Arrhythmia recurrence after RFA was assessed in 66 HCM patients and compared to 343 patients without HCM. AF recurrence was defined as AF on EKG or >30s of AF on ICD/pacemaker interrogation or on monitoring devices after a 3-month blanking period. Kaplan-Meier analysis was performed to compare arrhythmia recurrence rate and timing.
Result(s): The EF of HCM patients was higher than that of the non-HCM patients in both the PAAF and PEAF groups (65.5 and 63.0% vs 61.4 and 53.3%, respectively, p<0.001); within the HCM group, the clinical characteristics of the genetically (+) HCM group (n=14) did not differ from those of the genetically (-) group (n=12). Arrhythmia recurrence at 1 year in PAAF and PEAF was not significantly different between HCM and non-HCM patients (18% vs 11%, p=0.2, and 33% vs 26%, p=1), nor was mean time to arrhythmia recurrence (PAAF 193+/-48 vs 181+/-59 days, p=0.8, and PEAF 175+/-58 vs 168+/-20 days, p=0.6). Recurrence rates over the entire follow-up period of the HCM patients were 54 and 85% in the PAAF and PEAF groups (1076+/-187 and 1050+/- 201 days of follow-up), respectively. Amongst HCM patients with LVOT gradients >70mmHg (PAAF, n = 8, and PEAF, n = 3) longer-term rates of arrhythmia recurrence were similar at 88% and 67% (p=0.9).
Conclusion(s): Arrhythmia recurrence at 1 year following AF ablation in HCM patients is similar to that of non-HCM AF patients regardless of the type of AF. Absolute rates of atrial arrhythmia recurrence in HCM patients at >3 years post ablation are considerable. Confirmed HCM mutations and severe LVOT gradients do not modify the outcome of AF ablation.
Copyright
EMBASE:2002296056
ISSN: 1556-3871
CID: 4001852

Utilization of a Radiation Safety Time-Out Reduces Radiation Exposure During Electrophysiology Procedures

Aizer, Anthony; Qiu, Jessica K; Cheng, Austin V; Wu, Patrick B; Holmes, Douglas S; Wagner, Steven R; Bernstein, Scott A; Park, David S; Cartolano, Barbara; Barbhaiya, Chirag R; Chinitz, Larry A
OBJECTIVES/OBJECTIVE:This study sought to determine whether a radiation safety time-out reduces radiation exposure in electrophysiology procedures. BACKGROUND:Time-outs are integral to improving quality and safety. The authors hypothesized that a radiation safety time-out would reduce radiation exposure levels for patients and the health care team members. METHODS:The study was performed at the New York University Langone Health Electrophysiology Lab. Baseline data were collected for 6 months prior to the time-out. On implementation of the time-out, data were collected prospectively with analyses to be performed every 3 months. The primary endpoint was dose area product. The secondary endpoints included reference point dose, fluoroscopy time, use of additional shielding, and use of alternative imaging such as intracardiac and intravascular ultrasound. RESULTS:, representing a 21% reduction (p = 0.007). The median reference point dose prior to time-out was 163 mGy, and during the time-out was 122 mGy (p = 0.011). The use of sterile disposable protective shields and ultrasound imaging for access increased significantly during the time-out. CONCLUSIONS:A radiation safety time-out significantly reduces radiation exposure in electrophysiology procedures. Electrophysiology laboratories, as well as other areas of cardiovascular medicine using fluoroscopy, should strongly consider the use of radiation safety time-outs to reduce radiation exposure and improve safety.
PMID: 31122386
ISSN: 2405-5018
CID: 3899572