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  1. Article ; Online: Optimizer Smart System for the treatment of chronic heart failure: Overview of its safety and efficacy.

    Chera, Habib Hymie / Al-Sadawi, Mohammed / Michelakis, Nickolaos / Spinelli, Michael

    Expert review of medical devices

    2021  Volume 18, Issue 6, Page(s) 505–512

    Abstract: ... ...

    Abstract Introduction
    MeSH term(s) Cardiac Resynchronization Therapy ; Chronic Disease ; Defibrillators, Implantable ; Heart Failure/therapy ; Humans ; Multicenter Studies as Topic ; Myocardial Contraction ; Treatment Outcome
    Language English
    Publishing date 2021-07-29
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2250857-0
    ISSN 1745-2422 ; 1743-4440
    ISSN (online) 1745-2422
    ISSN 1743-4440
    DOI 10.1080/17434440.2021.1923478
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  2. Article ; Online: Risk of malignant ventricular arrhythmias in patients with mildly to moderately reduced ejection fraction after permanent pacemaker implantation.

    Dai, Matthew / Peterson, Connor / Chorin, Udi / Leiva, Orly / Katz, Moshe / Sliman, Hend / Aizer, Anthony / Barbhaiya, Chirag / Bernstein, Scott / Holmes, Douglas / Knotts, Robert / Park, David / Spinelli, Michael / Chinitz, Larry / Jankelson, Lior

    Heart rhythm

    2024  

    Abstract: Background: Many patients with mildly to moderately reduced left ventricular ejection fraction (LVEF) who require permanent pacemaker (PPM) implantation do not have a concurrent indication for implantable cardioverter-defibrillator (ICD) therapy. ... ...

    Abstract Background: Many patients with mildly to moderately reduced left ventricular ejection fraction (LVEF) who require permanent pacemaker (PPM) implantation do not have a concurrent indication for implantable cardioverter-defibrillator (ICD) therapy. However, the risk of ventricular tachycardia/ventricular fibrillation (VT/VF) in this population is unknown.
    Objective: The aim of this study was to describe the risk of VT/VF after PPM implantation in patients with mildly to moderately reduced LVEF.
    Methods: Retrospective analysis was performed of 243 patients with LVEF between 35% and 49% who underwent PPM placement and did not meet indications for an ICD. The primary end point was occurrence of sustained VT/VF. Competing risks regression was performed to calculate subhazard ratios for the primary end point.
    Results: Median follow-up was 27 months; 73% of patients were male, average age was 79 ± 10 years, average LVEF was 42% ± 4%, and 70% were New York Heart Association class II or above. Most PPMs were implanted for sick sinus syndrome (34%) or atrioventricular block (50%). Of 243 total patients, 11 (4.5%) met the primary end point of VT/VF. Multivessel coronary artery disease (CAD) was associated with significantly higher rates of VT/VF, with a subhazard ratio of 5.4 (95% CI, 1.5-20.1; P = .01). Of patients with multivessel CAD, 8 of 82 (9.8%) patients met the primary end point for an annualized risk of 4.3% per year.
    Conclusion: Patients with mildly to moderately reduced LVEF and multivessel CAD undergoing PPM implantation are at increased risk for the development of malignant ventricular arrhythmias. Patients in this population may benefit from additional risk stratification for VT/VF and consideration for upfront ICD implantation.
    Language English
    Publishing date 2024-03-13
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2229357-7
    ISSN 1556-3871 ; 1547-5271
    ISSN (online) 1556-3871
    ISSN 1547-5271
    DOI 10.1016/j.hrthm.2024.03.026
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  3. Article ; Online: Temporal trends in atrial fibrillation ablation procedures at an academic medical center: 2011-2021.

    Kushnir, Alexander / Barbhaiya, Chirag R / Aizer, Anthony / Jankelson, Lior / Holmes, Douglas / Knotts, Robert / Park, David / Spinelli, Michael / Bernstein, Scott / Chinitz, Larry A

    Journal of cardiovascular electrophysiology

    2023  Volume 34, Issue 4, Page(s) 800–807

    Abstract: Introduction: Radiofrequency ablation technology for treating atrial fibrillation (AF) has evolved rapidly over the past decade. We investigated the impact of technological and procedural advances on procedure times and ablation outcomes at a major ... ...

    Abstract Introduction: Radiofrequency ablation technology for treating atrial fibrillation (AF) has evolved rapidly over the past decade. We investigated the impact of technological and procedural advances on procedure times and ablation outcomes at a major academic medical center over a 10-year period.
    Methods: Clinical data was collected from patients who presented to NYU Langone Health between 2011 and 2021 for a first-time AF ablation. Time to redo AF ablation or direct current cardioversion (DCCV) for recurrent AF during a 3-year follow-up period was determined and correlated with ablation technology and practices, antiarrhythmic medications, and patient comorbid conditions.
    Results: From 2011 to 2021, the cardiac electrophysiology lab adopted irrigated-contact force ablation catheters, high-power short duration ablation lesions, steady-pacing, jet ventilation, and eliminated stepwise linear ablation for AF ablation. During this time the number of first time AF ablations increased from 403 to 1074, the percentage of patients requiring repeat AF-related intervention within 3-years of the index procedure dropped from 22% to 14%, mean procedure time decreased from 271 ± 65 to 135 ± 36 min, and mean annual major adverse event rate remained constant at 1.1 ± 0.5%. Patient comorbid conditions increased during this time period and antiarrhythmic use was unchanged.
    Conclusion: Rates of redo-AF ablation or DCCV following an initial AF ablation at a single center decreased 36% over a 10-year period. Procedural and technological changes likely contributed to this improvement, despite increased AF related comorbidities.
    MeSH term(s) Humans ; Atrial Fibrillation/surgery ; Treatment Outcome ; Anti-Arrhythmia Agents/therapeutic use ; Time Factors ; Catheter Ablation/methods
    Chemical Substances Anti-Arrhythmia Agents
    Language English
    Publishing date 2023-02-14
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1025989-2
    ISSN 1540-8167 ; 1045-3873
    ISSN (online) 1540-8167
    ISSN 1045-3873
    DOI 10.1111/jce.15839
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  4. Article ; Online: Comparison of combined substrate-based mapping techniques to identify critical sites for ventricular tachycardia ablation.

    Khan, Hassan / Bonvissuto, Matthew R / Rosinski, Elizabeth / Shokr, Mohamed / Metcalf, Kara / Jankelson, Lior / Kushnir, Alexander / Park, David S / Bernstein, Scott A / Spinelli, Michael A / Aizer, Anthony / Holmes, Douglas / Chinitz, Larry A / Barbhaiya, Chirag R

    Heart rhythm

    2023  Volume 20, Issue 6, Page(s) 808–814

    Abstract: Background: Established electroanatomic mapping techniques for substrate mapping for ventricular tachycardia (VT) ablation includes voltage mapping, isochronal late activation mapping (ILAM), and fractionation mapping. Omnipolar mapping (Abbott Medical, ...

    Abstract Background: Established electroanatomic mapping techniques for substrate mapping for ventricular tachycardia (VT) ablation includes voltage mapping, isochronal late activation mapping (ILAM), and fractionation mapping. Omnipolar mapping (Abbott Medical, Inc.) is a novel optimized bipolar electrogram creation technique with integrated local conduction velocity annotation. The relative utilities of these mapping techniques are unknown.
    Objective: The purpose of this study was to evaluate the relative utility of various substrate mapping techniques for the identification of critical sites for VT ablation.
    Methods: Electroanatomic substrate maps were created and retrospectively analyzed in 27 patients in whom 33 VT critical sites were identified.
    Results: Both abnormal bipolar voltage and omnipolar voltage encompassed all critical sites and were observed over a median of 66 cm
    Conclusion: ILAM, fractionation, and CV mapping each identified distinct critical sites and provided a smaller area of interest than did voltage mapping alone. The sensitivity of novel mapping modalities improved with greater local point density.
    MeSH term(s) Humans ; Tachycardia, Ventricular/diagnosis ; Tachycardia, Ventricular/surgery ; Retrospective Studies ; Electrophysiologic Techniques, Cardiac/methods ; Catheter Ablation/methods
    Language English
    Publishing date 2023-02-28
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2229357-7
    ISSN 1556-3871 ; 1547-5271
    ISSN (online) 1556-3871
    ISSN 1547-5271
    DOI 10.1016/j.hrthm.2023.02.023
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  5. Article: 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

    The Journal of innovations in cardiac rhythm management

    2021  Volume 12, Issue Suppl 1, Page(s) 45–46

    Language English
    Publishing date 2021-01-15
    Publishing country United States
    Document type Journal Article
    ISSN 2156-3977
    ISSN 2156-3977
    DOI 10.19102/icrm.2021.120111S
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  6. Article ; Online: Subclinical atrial fibrillation and the risk of stroke.

    Wiesel, Joseph / Spinelli, Michael

    The New England journal of medicine

    2012  Volume 366, Issue 14, Page(s) 1351; author reply 1352–3

    MeSH term(s) Atrial Fibrillation/complications ; Defibrillators, Implantable ; Embolism/etiology ; Female ; Humans ; Male ; Pacemaker, Artificial ; Stroke/etiology
    Language English
    Publishing date 2012-04-05
    Publishing country United States
    Document type Comment ; Letter
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMc1201844#SA2
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    Ua VI Zs.34: Show issues Location:
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  7. Article ; Online: Subcutaneous versus transvenous implantable defibrillator in patients with hypertrophic cardiomyopathy.

    Jankelson, Lior / Garber, Leonid / Sherrid, Mark / Massera, Daniele / Jones, Paul / Barbhaiya, Chirag / Holmes, Douglas / Knotts, Robert / Bernstein, Scott / Spinelli, Michael / Park, David / Aizer, Anthony / Chinitz, Larry

    Heart rhythm

    2022  Volume 19, Issue 5, Page(s) 759–767

    Abstract: Background: Hypertrophic cardiomyopathy (HCM) is the most prevalent inherited cardiomyopathy. The implantable cardioverter-defibrillator (ICD) is important for prevention of sudden cardiac death (SCD) in patients at high risk. In recent years, the ... ...

    Abstract Background: Hypertrophic cardiomyopathy (HCM) is the most prevalent inherited cardiomyopathy. The implantable cardioverter-defibrillator (ICD) is important for prevention of sudden cardiac death (SCD) in patients at high risk. In recent years, the subcutaneous implantable cardioverter-defibrillator (S-ICD) has emerged as a viable alternative to the transvenous implantable cardioverter-defibrillator (TV-ICD). The S-ICD does not require intravascular access; however, it cannot provide antitachycardia pacing (ATP) therapy.
    Objective: The purpose of this study was to assess the real-world incidence of ICD therapy in patients with HCM implanted with TV-ICD vs S-ICD.
    Methods: We compared the incidence of ATP and shock therapies among all HCM patients with S-ICD and TV-ICD enrolled in the Boston Scientific ALTITUDE database. Cumulative Kaplan-Meier incidence was used to compare therapy-free survival, and Cox proportional hazard ratios were calculated. We performed unmatched as well as propensity match analyses.
    Results: We included 2047 patients with TV-ICD and 626 patients with S-ICD, followed for an average of 1650.5 ± 1038.5 days and 933.4 ± 550.6 days, respectively. Patients with HCM and TV-ICD had a significantly higher rate of device therapy compared to those with S-ICD (32.7 vs 14.5 therapies per 100 patient-years, respectively; P <.001), driven by a high incidence of ATP therapy in the TV-ICD group, which accounted for >67% of therapies delivered. Shock incidence was similar between groups, both in the general and the matched cohorts.
    Conclusion: Patients with HCM and S-ICD had a significantly lower therapy rate than patients with TV-ICD without difference in shock therapy, suggesting potentially unnecessary ATP therapy. Empirical ATP programming in patients with HCM may be unbeneficial.
    MeSH term(s) Adenosine Triphosphate ; Cardiomyopathy, Hypertrophic/complications ; Cardiomyopathy, Hypertrophic/diagnosis ; Cardiomyopathy, Hypertrophic/therapy ; Death, Sudden, Cardiac/epidemiology ; Death, Sudden, Cardiac/etiology ; Death, Sudden, Cardiac/prevention & control ; Defibrillators, Implantable/adverse effects ; Humans ; Treatment Outcome
    Chemical Substances Adenosine Triphosphate (8L70Q75FXE)
    Language English
    Publishing date 2022-01-14
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2229357-7
    ISSN 1556-3871 ; 1547-5271
    ISSN (online) 1556-3871
    ISSN 1547-5271
    DOI 10.1016/j.hrthm.2022.01.013
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  8. Article ; Online: Outcomes and atrial substrate analysis in patients with HIV undergoing atrial fibrillation ablation.

    Cheng, Austin / Qiu, Jessica / Barbhaiya, Chirag / Garber, Leonid / Holmes, Douglas / Jankelson, Lior / Kushnir, Alexander / Knotts, Robert / Bernstein, Scott / Park, David / Spinelli, Michael / Chinitz, Larry / Aizer, Anthony

    Journal of cardiovascular electrophysiology

    2022  Volume 34, Issue 3, Page(s) 575–582

    Abstract: Introduction: Patients with HIV infection have increased risk of atrial fibrillation, but the pathophysiologic mechanisms and the utility of catheter ablation in this population are not well-studied. We aimed to characterize outcomes of atrial ... ...

    Abstract Introduction: Patients with HIV infection have increased risk of atrial fibrillation, but the pathophysiologic mechanisms and the utility of catheter ablation in this population are not well-studied. We aimed to characterize outcomes of atrial fibrillation ablation and left atrial substrate in patients with HIV.
    Methods: The study was a retrospective propensity score-matched analysis of patients with and without HIV undergoing atrial fibrillation ablation. A search was performed in the electronic medical record for all patients with HIV who received initial atrial fibrillation ablation from 2011 to 2020. After calculating propensity scores for HIV, matching was performed with patients without HIV by using nearest-neighbor matching without replacement in a 1:2 ratio. The primary outcome was freedom from atrial arrhythmia and secondary outcomes were freedom from atrial fibrillation, freedom from atrial tachycardia, and freedom from repeat ablation, compared by log-rank analysis. The procedures of patients with HIV who underwent repeat ablation at our institution were further analyzed for etiology of recurrence. To further characterize the left atrial substrate, a subsequent case-control analysis was then performed for a set of randomly chosen 10 patients with HIV matched with 10 without HIV to compare minimum and maximum voltage at nine pre-specified regions of the left atrium.
    Results: Twenty-seven patients with HIV were identified. All were prescribed antiretroviral therapy at time of ablation. These patients were matched with 54 patients without HIV by propensity score. 86.4% of patients with HIV and 76.9% of controls were free of atrial fibrillation or atrial tachycardia at 1 year (p = .509). Log-rank analysis showed no difference in freedom from atrial arrhythmia (p value .971), atrial fibrillation (p-value .346), atrial tachycardia (p value .306), or repeat ablation (p value .401) after initial atrial fibrillation ablation in patients with HIV compared to patients without HIV. In patients with HIV with recurrent atrial fibrillation, the majority had pulmonary vein reconnection (67%). There were no significant differences in minimum or maximum voltage at any of the nine left atrial regions between the matched patients with and without HIV.
    Conclusions: Ablation to treat atrial fibrillation in patients with HIV, but without overt AIDS is frequently successful therapy. The majority of patients with recurrence of atrial fibrillation had pulmonary vein reconnection, suggesting infrequent nonpulmonary vein substrate. In this population, the left atrial voltage in patients with HIV is similar to that of patients without HIV. These findings suggest that the pulmonary veins remain a critical component to the initiation and maintenance of atrial fibrillation in patients with HIV.
    MeSH term(s) Humans ; Atrial Fibrillation/surgery ; Retrospective Studies ; HIV Infections/complications ; HIV Infections/surgery ; Treatment Outcome ; Heart Atria ; Tachycardia, Supraventricular ; Pulmonary Veins/surgery ; Catheter Ablation/adverse effects ; Recurrence
    Language English
    Publishing date 2022-12-16
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1025989-2
    ISSN 1540-8167 ; 1045-3873
    ISSN (online) 1540-8167
    ISSN 1045-3873
    DOI 10.1111/jce.15774
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  9. Article: ICD shocks and complications in patients with inherited arrhythmia syndromes.

    Siskin, Matthew / Cerrone, Marina / Shokr, Mohamed / Aizer, Anthony / Barbhaiya, Chirag / Dai, Matthew / Bernstein, Scott / Holmes, Douglas / Knotts, Robert / Park, David S / Spinelli, Michael / Chinitz, Larry A / Jankelson, Lior

    International journal of cardiology. Heart & vasculature

    2021  Volume 37, Page(s) 100908

    Abstract: Background: There is limited information on the long-term outcomes of ICDs in patients with inherited arrhythmia syndromes.: Methods: Prospective registry study of inherited arrhythmia patients with an ICD. Incidence of therapies and complications ... ...

    Abstract Background: There is limited information on the long-term outcomes of ICDs in patients with inherited arrhythmia syndromes.
    Methods: Prospective registry study of inherited arrhythmia patients with an ICD. Incidence of therapies and complications were measured as 5-year cumulative incidence proportions and analyzed with the Kaplan-Meier method. Incidence was compared by device indication, diagnosis type and device type. Cox-regression analysis was used to identify predictors of appropriate shock and device complication.
    Results: 123 patients with a mean follow up of 6.4 ± 4.8 years were included. The incidence of first appropriate shock was 56.52% vs 24.44%, p < 0.05 for cardiomyopathy and channelopathy patients, despite similar ejection fraction (61% vs 60%, p = 0.6). The incidence of first inappropriate shock was 13.46% vs 56.25%, p < 0.01 for single vs. multi-lead devices. The incidence of first lead complication was higher for multi-lead vs. single lead devices, 43.75% vs. 17.31%, p = 0.04. Patients with an ICD for secondary prevention were more likely to receive an appropriate shock than those with primary prevention indication (HR 2.21, CI 1.07-4.56, p = 0.03). Multi-lead devices were associated with higher risk of inappropriate shock (HR 3.99, CI 1.27-12.52, p = 0.02), with similar appropriate shock risk compared to single lead devices. In 26.5% of patients with dual chamber devices, atrial sensing or pacing was not utilized.
    Conclusion: The rate of appropriate therapies and ICD complications in patients with inherited arrhythmia is high, particularly in cardiomyopathies with multi-lead devices. Risk-benefit ratio should be carefully considered when assessing the indication and type of device in this population.
    Language English
    Publishing date 2021-10-30
    Publishing country Ireland
    Document type Journal Article
    ZDB-ID 2818464-6
    ISSN 2352-9067
    ISSN 2352-9067
    DOI 10.1016/j.ijcha.2021.100908
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  10. Article ; Online: Time to diagnosis of acute complications after cardiovascular implantable electronic device insertion and optimal timing of discharge within the first 24 hours.

    Wadhwani, Lalit / Occhipinti, Karen / Selim, Ahmed / Manmadhan, Arun / Kushnir, Alexander / Barbhaiya, Chirag / Jankelson, Lior / Holmes, Douglas / Bernstein, Scott / Spinelli, Michael / Knotts, Robert / Park, David S / Chinitz, Larry A / Aizer, Anthony

    Heart rhythm

    2021  Volume 18, Issue 12, Page(s) 2110–2114

    Abstract: Background: More than 3 million cardiovascular implantable electronic devices (CIEDs) are implanted annually. There are minimal data regarding the timing of diagnosis of acute complications after implantation. It remains unclear whether patients can be ... ...

    Abstract Background: More than 3 million cardiovascular implantable electronic devices (CIEDs) are implanted annually. There are minimal data regarding the timing of diagnosis of acute complications after implantation. It remains unclear whether patients can be safely discharged less than 24 hours postimplantation.
    Objective: The purpose of this study was to determine the precise timing of acute complication diagnosis after CIED implantation and optimal timing for same-day discharge.
    Methods: A retrospective cohort analysis of adults 18 years or older who underwent CIED implantation at a large urban quaternary care medical center between June 1, 2015, and March 30, 2020, was performed. Standard of care included overnight observation and chest radiography 6 and 24 hours postprocedure. Medical records were reviewed for the timing of diagnosis of acute complications. Acute complications included pneumothorax, hemothorax, pericardial effusion, lead dislodgment, and implant site hematoma requiring surgical intervention.
    Results: A total of 2421 patients underwent implantation. Pericardial effusion or cardiac tamponade was diagnosed in 13 patients (0.53%), pneumothorax or hemothorax in 19 patients (0.78%), lead dislodgment in 11 patients (0.45%), and hematomas requiring surgical intervention in 5 patients (0.2%). Of the 48 acute complications, 43 (90%) occurred either within 6 hours or more than 24 hours after the procedure. Only 3 acute complications identified between 6 and 24 hours required intervention during the index hospitalization (0.12% of all cases).
    Conclusion: Most acute complications are diagnosed either within the first 6 hours or more than 24 hours after implantation. With rare exception, patients can be considered for discharge after 6 hours of appropriate monitoring.
    MeSH term(s) Aged ; Cardiac Resynchronization Therapy/adverse effects ; Cardiac Resynchronization Therapy/methods ; Cardiac Tamponade/epidemiology ; Cardiac Tamponade/therapy ; Clinical Observation Units/statistics & numerical data ; Defibrillators, Implantable/adverse effects ; Early Diagnosis ; Early Medical Intervention/methods ; Early Medical Intervention/standards ; Early Medical Intervention/statistics & numerical data ; Female ; Hematoma/epidemiology ; Hematoma/therapy ; Hemothorax/epidemiology ; Hemothorax/therapy ; Humans ; Male ; Pacemaker, Artificial/adverse effects ; Postoperative Complications/classification ; Postoperative Complications/diagnosis ; Postoperative Complications/etiology ; Postoperative Complications/prevention & control ; Prosthesis Implantation/adverse effects ; Prosthesis Implantation/instrumentation ; Prosthesis Implantation/methods ; Radiography, Thoracic/methods ; Retrospective Studies ; Standard of Care ; Time-to-Treatment/organization & administration
    Language English
    Publishing date 2021-09-10
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2229357-7
    ISSN 1556-3871 ; 1547-5271
    ISSN (online) 1556-3871
    ISSN 1547-5271
    DOI 10.1016/j.hrthm.2021.09.008
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