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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

Lesion Sequence and Catheter Spatial Stability Affect Lesion Quality Markers in Atrial Fibrillation Ablation

Jankelson, Lior; Dai, Matthew; Aizer, Anthony; Bernstein, Scott; Park, David S; Holmes, Douglas; Chinitz, Larry A; Barbhaiya, Chirag
OBJECTIVES/OBJECTIVE:This study sought to analyze high-frequency catheter excursion in relation to lesion quality markers in 20 consecutive patients undergoing first-time radiofrequency (RF) ablation for paroxysmal atrial fibrillation (AF). BACKGROUND:Ablation therapy for AF requires the delivery of durable lesions. The extent to which lesion sequence, catheter spatial stability, and anatomic location influence lesion formation during RF ablation of AF is not well understood. METHODS:Three-dimensional spatial excursion of the ablation catheter sampled at 60 Hz during pre-specified pairs of RF lesions was extracted from the CARTO3 System (Biosense Webster Inc., Irvine, California) and analyzed by using custom-developed MATLAB software (MathWorks, Natick, Massachusetts) to define precise catheter spatial stability during RF ablation. Ablation parameters including bipolar electrogram amplitude reduction, impedance decline and transmurality-associated unipolar electrogram (TUE) as evidence of lesion transmurality during lesion placement were recorded and analyzed. RESULTS:We collected 437,760 position data points during lesion placement. Ablation catheter spatial stability and lesion formation parameters varied considerably by anatomic location. Lesions placed immediately had similar bipolar electrogram amplitude reduction, smaller impedance decline, but higher likelihood of achieving TUE compared to delayed lesions. Greater catheter spatial stability correlated with lesser impedance decline. CONCLUSIONS:Lesion sequence, ablation catheter spatial stability, and anatomic location are important modifiers of RF lesion formation. Lesions placed immediately are more likely to exhibit TUE. Greater ablation catheter stability is associated with lesser impedance decline but greater likelihood of TUE.
PMID: 33516716
ISSN: 2405-5018
CID: 4775692

QT interval dynamics and triggers for QT prolongation immediately following cardiac arrest

Cohen, Roi Bar; Dai, Matthew; Aizer, Anthony; Barbhaiya, Chirag; Peterson, Connor; Bernstein, Scott; Park, David; Spinelli, Michael; Chinitz, Larry; Jankelson, Lior
BACKGROUND:The prolongation in QT interval typically observed following cardiac arrest is considered to be multifactorial and induced by external triggers such as hypothermia therapy and exposure to antiarrhythmic medications. OBJECTIVE:To evaluate the corrected QT interval (QTc) dynamics in the first 10 days following cardiac arrest with respect to the etiology of arrest, hypothermia and QT prolonging medications. METHODS:We enrolled 104 adult survivors of cardiac arrest, where daily ECG was available for at least 3 days. We followed their QT and QRS intervals for the first 10 days of hospitalization. We used both Bazett and Fridericia formulas to correct for heart rate. For patients with QRS < 120 we analyzed the QTc interval (n = 90) and for patients with QRS > 120 ms we analyzed the JTc (n = 104) vs. including only the narrow QRS samples (n = 89). We stratified patients by 3 groups: (1) presence of ischemic heart disease (IHD) (2) treatment with hypothermia protocol, and (3) treatment with QTc prolonging medications. Additionally, genetic information obtained during hospitalization was analyzed. RESULTS:QTc and JTc intervals were significantly prolonged in the first 6 days. Maximal QTc/JTc prolongation was observed in day 2 (QTcB = 497 ± 55). There were no differences in daily QTc/JTc and QRS intervals in the first 2 days post arrest between patients with or without hypothermia induction but such difference. All subgroups demonstrated significantly prolonged QTc/JTc interval regardless of the presence of IHD, hypothermia protocol or QTc prolonging medication exposure. Our results were consistent for both Bazetts' and Frediricia correction and for any QRS duration. Prolongation of the JTcB beyond 382 ms after day 3 predicted sustained QTc/JTc prolongation beyond day 6 with an ROC of 0.78. CONCLUSIONS:QTc/JTc interval is significantly and independently prolonged post SCA, regardless of known QT prolonging triggers. Normalization of the QTc post cardiac arrest should be expected only after day 6 of hospitalization. Assessment of the QTc for adjudication of the etiology of arrest or for monitoring the effect of QT prolonging medications may be unreliable.
PMID: 33652119
ISSN: 1873-1570
CID: 4801392

Sudden Cardiac Arrest in a Patient With Mitral Valve Prolapse and LMNA and SCN5A Mutations [Case Report]

Mahajan, Asha M; Itan, Yuval; Cerrone, Marina; Horowitz, James; Borneman, Linda; Chinitz, Larry; Jankelson, Lior
Bileaflet mitral valve prolapse (Bi-MVP) is associated with increased risk for cardiac arrest. We describe a patient who presented after a cardiac arrest with Bi-MVP and variants in Lamin A/C (LMNA) and the sodium channel alpha-subunit 5a (SCN5A). Genetic variants may be the culprit for arrhythmogenesis in Bi-MVP patients. (Level of Difficulty: Intermediate.).
PMCID:8310969
PMID: 34317510
ISSN: 2666-0849
CID: 4949482

Elimination of Incessant Ventricular Tachycardia in Ischemic Cardiomyopathy with High-density Grid Technology

Barbhaiya, Chirag R; Metcalf, Kara; Bonvissuto, M Reed; Spinelli, Michael; Aizer, Anthony; Holmes, Douglas; Chinitz, Larry A
PMCID:7885946
PMID: 33604121
ISSN: 2156-3977
CID: 4787202

Electrocardiographic Risk Stratification in COVID-19 Patients

Chorin, Ehud; Dai, Matthew; Kogan, Edward; Wadhwani, Lalit; Shulman, Eric; Nadeau-Routhier, Charles; Knotts, Robert; Bar-Cohen, Roi; Barbhaiya, Chirag; Aizer, Anthony; Holmes, Douglas; Bernstein, Scott; Spinelli, Michael; Park, David; Chinitz, Larry; Jankelson, Lior
Background: The COVID-19 pandemic has resulted in worldwide morbidity at unprecedented scale. Troponin elevation is a frequent laboratory finding in hospitalized patients with the disease, and may reflect direct vascular injury or non-specific supply-demand imbalance. In this work, we assessed the correlation between different ranges of Troponin elevation, Electrocardiographic (ECG) abnormalities, and mortality. Methods: We retrospectively studied 204 consecutive patients hospitalized at NYU Langone Health with COVID-19. Serial ECG tracings were evaluated in conjunction with laboratory data including Troponin. Mortality was analyzed in respect to the degree of Troponin elevation and the presence of ECG changes including ST elevation, ST depression or T wave inversion. Results: Mortality increased in parallel with increase in Troponin elevation groups and reached 60% when Troponin was >1 ng/ml. In patients with mild Troponin rise (0.05-1.00 ng/ml) the presence of ECG abnormality and particularly T wave inversions resulted in significantly greater mortality. Conclusion: ECG repolarization abnormalities may represent a marker of clinical severity in patients with mild elevation in Troponin values. This finding can be used to enhance risk stratification in patients hospitalized with COVID-19.
PMCID:7884321
PMID: 33604358
ISSN: 2297-055x
CID: 4787212

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

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

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