Background: Data suggests that same day discharge after implantation of trans-venous pacemakers is safe and feasible. We sought to determine whether same day discharge was feasible and safe following implantation of Medtronic MICRA leadless pacemakers. Methods: We retrospectively identified all patients undergoing MICRA placement at our institution between April 2014 to August 2018 (n=167). Patients were stratified into two groups: those discharged on the same day as their procedure (SD, n=25), and those observed for at least one night in the hospital (HD, n=142). The primary endpoint included a composite of major complications including: access site complications, new pericardial effusion, device dislodgement, and need for device revision up to approximately 45 days of follow up. Results: SD and HD had similar age (75±13 vs. 75±13 years, p=0.923), prevalence of male sex (49 vs. 44%, p=0.669), and frequency of high-grade heart block as an indication for pacing (38 vs. 32%, p=0.596). There were more Caucasians in the SD group (72 vs. 66%, p=0.038). The rate of the composite endpoint was statistically non-significantly higher in the HD group (3.5% vs. 0.0%, p=1.00). The rates of each individual components comprising the composite endpoint were similar between groups. Conclusions: Our data suggest that in appropriately selected patients, same day discharge can occur safely following Micra leadless pacemaker implantation.
Background: Pulmonary vein (PV) reverse remodeling has been recognized following atrial fibrillation (AF) ablation. However, the extent of physiologic reverse remodeling after AF ablation and the potential impact of reverse remodeling on the radiographic diagnosis of PV stenosis have not been well characterized. Methods: From January 2004 to February 201 186 patients underwent paired cardiac magnetic resonance imaging (MRI) to delineate PV orifice dimensions before and after (mean 109 ± 61 days) an initial AF ablation. Results: Negative remodeling of the PV orifice cross sectional area occurred in 67.8% of veins with a mean reduction in area of 21.0 ± 14.1%, and positive remodeling was seen in the remaining PVs with an increase in area of 22.1 ± 23.4% compared to baseline. No PVs demonstrated a reduction in cross-sectional area of < 75% (maximum reduction observed was 58%). Negative remodeling of the PV long axis dimension was observed in 55.2% of veins with a mean reduction of 14.6 ± 9.2% compared to pre-ablation and positive remodeling was observed in 25.3% of PVs with a mean increase in diameter of 14.7 ± 12.6%. Only 1 PV demonstrated a reduction in orifice diameter of < 50%. There were no clinically evident or suspected cases of PV stenosis in this cohort. Conclusions: Negative remodeling of the PV orifice area was noted in the majority of PVs following AF ablation. However, in almost all cases, the extent of negative remodeling was well below commonly used thresholds for the radiographic diagnosis of PV stenosis.
AIM: To identify predictors of need for repeat procedures after initial atrial fibrillation (AF) ablation. METHODS: We identified a cohort undergoing first time AF ablation at our institution from January 2004 to February 2014 who had cardiac magnetic resonance (CMR) imaging performed prior to ablation. Clinical variables and anatomic characteristics (determined from CMR) were assessed as predictors of need for repeat ablation. The decision regarding need for and timing of repeat ablation was at the discretion of the treating physician. RESULTS: From a cohort of 331 patients, 142 patients (43%) underwent repeat ablation at a mean of 13.6 ± 18.4 mo after the index procedure. Both male gender (81% vs 71%, P = 0.05) and lower ejection fraction (57.4% ± 10.3% vs 59.8% ± 9.4%, P = 0.04) were associated with need for repeat ablation. On pre-ablation CMR, mean pulmonary vein (PV) diameters were significantly larger in all four PVs among patients requiring repeat procedures. In multivariate analysis, increased right superior PV diameter significantly predicted need for repeat ablation (odds ratio 1.08 per millimeter increase in diameter, 95%CI: 1.00-1.16, P = 0.05). There were also trends toward significance for increased left and right inferior PV sizes among those requiring repeat procedures. CONCLUSION: Increased PV size predicts the need for repeat AF ablation, with each millimeter increase in PV diameter associated with an approximately 5%-10% increased risk of requiring repeat procedures.
The treatment of AF has evolved over the past decade with increasing use of catheter ablation in patients refractory to medical therapy. While pulmonary vein isolation using endocardial catheter ablation has been successful in paroxysmal AF, the results have been more controversial in patients with long-standing persistent AF where extrapulmonary venous foci are increasingly recognised in the initiation and maintenance of AF. Hybrid ablation is the integration of minimally invasive epicardial ablation with endocardial catheter ablation, and has been increasingly used in this population with better results. The aim of this article was to analyse and discuss the evidence for the integration of catheter and minimally invasive surgical approaches to treat AF with specific focus on convergent ablation and exclusion of the left atrial appendage using a surgically applied clip.
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Suvash Shrestha;
Kristen M. Plasseraud;
Kevin Makati;
Nitesh Sood;
Ammar M. Killu;
Tahmeed Contractor;
Syed Ahsan;
David De Lurgio;
Christian C. Shults;
Zayd A. Eldadah;
Andrea Russo;
Bradley Knight;
Yisachar Jesse Greenberg;
Felix Yang
Background: Hybrid Convergent ablation for atrial fibrillation (AF) combines minimally invasive surgical (epicardial) and catheter (endocardial) ablation. The procedural goal is to achieve more extensive, enduring ablation of AF substrate around the pulmonary veins, posterior wall, and vestibule of the posterior wall left atrium. Objective: To perform a systematic review and meta-analysis on safety and effectiveness of contemporary Hybrid Convergent procedures. Methods: PubMed, Embase, and manual searches identified primary research articles on Hybrid Convergent. Inclusion criteria focused on contemporary practices (epicardial ablation device and lesions). Clinical outcomes at 1 year or later follow-up, patient population, procedural details, and major adverse events (MAE) were recorded. Results: Of 249 records, 6 studies (5 observational, 1 randomized controlled trial) including 551 patients were included. Endocardial energy sources included radiofrequency and cryoballoon. Hybrid Convergent ablation was mostly performed in patients with drug-refractory persistent and longstanding persistent AF. Mean preprocedural AF duration ranged between 2 and 5.1 years. Most patients (∼92%) underwent Hybrid Convergent in a single hospitalization. At 1 year follow-up or later, 69% (95% confidence interval [CI]: 61%–78%, n = 523) were free from atrial arrhythmias and 50% (95% CI: 42%–58%, n = 343) were free from atrial arrhythmias off antiarrhythmic drugs. Thirty-day MAE rate was 6% (95% CI: 3%–8%, n = 551). Conclusion: Hybrid Convergent ablation is an effective ablation strategy for persistent and longstanding persistent AF. Contemporary procedural approaches and published strategies aim to mitigate complications reported in early experience and address delayed inflammatory effusions.
Recent advances have been made in AF treatment Including the role of early rhythm control and landmark clinical trials using ablation therapy. However Some treatment gaps remain including the creation of durable lesions outside the pulmonary veins and effective treatment of longstanding persistent AF. A novel epicardial-endocardial ablation approach - the hybrid convergent procedure - was developed to combine surgical and catheter ablation techniques into a collaborative multidisciplinary approach to managing AF. In this review the authors discuss recently published data on hybrid convergent ablation including results of the CONVERGE clinical trial in the context of current challenges to treatment of persistent and long-standing persistent AF. The review also aims to provide perspective on outstanding questions and future directions in this area.
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Atul Verma;
David E. Haines;
Lucas V. Boersma;
Nitesh Sood;
Andrea Natale;
Francis E. Marchlinski;
Hugh Calkins;
Prashanthan Sanders;
Douglas L. Packer;
Karl-Heinz Kuck;
Gerhard Hindricks;
Birce Onal;
Jeffrey Cerkvenik;
Hiroshi Tada;
David De Lurgio
Background: Pulsed field ablation uses electrical pulses to cause nonthermal irreversible electroporation and induce cardiac cell death. Pulsed field ablation may have effectiveness comparable to traditional catheter ablation while preventing thermally mediated complications. Methods: The PULSED AF pivotal study (Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF) was a prospective, global, multicenter, nonrandomized, paired single-arm study in which patients with paroxysmal (n=150) or persistent (n=150) symptomatic atrial fibrillation (AF) refractory to class I or III antiarrhythmic drugs were treated with pulsed field ablation. All patients were monitored for 1 year using weekly and symptomatic transtelephonic monitoring; 3-, 6-, and 12-month ECGs; and 6- and 12-month 24-hour Holter monitoring. The primary effectiveness end point was freedom from a composite of acute procedural failure, arrhythmia recurrence, or antiarrhythmic escalation through 12 months, excluding a 3-month blanking period to allow recovery from the procedure. The primary safety end point was freedom from a composite of serious procedure- and device-related adverse events. Kaplan-Meier methods were used to evaluate the primary end points. Results: Pulsed field ablation was shown to be effective at 1 year in 66.2% (95% CI, 57.9 to 73.2) of patients with paroxysmal AF and 55.1% (95% CI, 46.7 to 62.7) of patients with persistent AF. The primary safety end point occurred in 1 patient (0.7%; 95% CI, 0.1 to 4.6) in both the paroxysmal and persistent AF cohorts. Conclusions: PULSED AF demonstrated a low rate of primary safety adverse events (0.7%) and provided effectiveness consistent with established ablation technologies using a novel irreversible electroporation energy to treat patients with AF. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04198701.
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Edoardo Bressi;
Thomas C Crawford;
Frank M Bogun;
Xiaokui Gu;
Kenneth A Ellenbogen;
Alexandra B Chicos;
Henri Roukoz;
Peter J Zimetbaum;
Steven J Kalbfleisch;
Francis D Murgatroyd;
David A Steckman;
Lynda E Rosenfeld;
Ann C Garlitski;
Kyoko Soejima;
Adarsh K Bhan;
Vasanth Vedantham;
Timm M Dickfeld;
David De Lurgio;
Pyotr G Platonov;
Matthew M Zipse;
Suguru Nishiuchi;
Matthew L Ortman;
Calambur Narasimhan;
Kris K Patton;
David G Rosenthal;
Siddharth S Mukerji;
Jarieke C Hoogendoorn;
Katja Zeppenfeld;
William H Sauer;
Jordana Kron
Arrhythmic risk stratification is essential in cardiac sarcoidosis (CS) but remains challenging because of the disease's unpredictable dynamic inflammatory nature. 1
Therefore, our goal was to describe the arrhythmia burden and outcomes in a large prospective cohort of patients from the CSC (Cardiac Sarcoidosis Consortium).
The CSC, an international collaborative research group committed to deepening the understanding of CS, has more than 25 participating sarcoidosis centers in the United States, India, Japan, United Kingdom, Sweden, and the Netherlands. Data are collected annually in a prospective secure, web‐based registry managed at the University of Michigan. The data that support the findings of this study are available from the corresponding author upon reasonable request. Institutional review board approval was obtained from each institution and informed written consent was obtained from each patient.
Background: The SanketLife is a low cost, portable, pocket sized 12 lead ECG mechanised by SanketLife app running on compatible iOS and Android phones that connect wirelessly via Bluetooth technology to the device. Objective: The current study was conducted to assess the diagnostic accuracy of SanketLife ECG in comparison to standard 12 lead ECG (GE-2000) in detection of cardiovascular diseases. Research design and methods: This was a prospective diagnostic test accuracy trial conducted in outpatient settings of a tertiary cardiac care centre in India. A total of 100 patients, attended cardiology OPD, were included in the study. Consecutive ECGs were taken by 12 lead standard ECG as well as by SanketLife ECG. Diagnostic accuracy variables such as sensitivity, specificity, negative and positive predictive value, negative and positive likelihood ratios were estimated. Ethical permission was taken from the Institutional ethical committee. Results & conclusion: The analysis showed a high degree of agreement and accuracy of SanketLife in detecting major cardiovascular conditions (Major Minnesota codes) such as Left and right bundle branch block, ST-segment elevation and ST-segment depression, AV conduction block. SanketLife showed high sensitivity (98.15%) and specificity (100%) in diagnosing major cardiovascular conditions.
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Adi Lador;
Leif E Peterson;
Vijay Swarup;
Paul A Schurmann;
Akash Makkar;
Rahul N Doshi;
David De Lurgio;
Charles A Athill;
Kenneth A Ellenbogen;
Andrea Natale;
Jayanthi Koneru;
Amish S Dave;
Irakli Giorgberidze;
Hamid Afshar;
Michelle L Guthrie;
Raquel Bunge;
Carlos A Morillo;
Neal S Kleiman;
Miguel Valderrabano
Background: The Vein of Marshall Ethanol for Untreated Persistent AF (VENUS) trial demonstrated that adding vein of Marshall (VOM) ethanol infusion to catheter ablation (CA) improves ablation outcomes in persistent atrial fibrillation (AF). There was significant heterogeneity in the impact of VOM ethanol infusion on rhythm control. Objective: The purpose of this study was to assess the association between outcomes and (1) achievement of bidirectional perimitral conduction block and (2) procedural volume. Methods: The VENUS trial randomized patients with persistent AF (N = 343) to CA combined with VOM ethanol or CA alone. The primary outcome (freedom from AF or atrial tachycardia [AT] lasting longer than 30 seconds after a single procedure) was analyzed by 2 categories: (1) successful vs no perimitral block and (2) high- (>20 patients enrolled) vs low-volume centers. Results: In patients with perimitral block, the primary outcome was reached 54.3% after VOM-CA and 37% after CA alone (P = .01). Among patients without perimitral block, freedom from AF/AT was 34.0% after VOM-CA and 37.0% after CA (P = .583). In high-volume centers, the primary outcome was reached in 56.4% after VOM-CA and 40.2% after CA (P = .01). In low-volume centers, freedom from AF/AT was 30.77% after VOM-CA and 32.61% after CA (P = .84). In patients with successful perimitral block from high-volume centers, the primary outcome was reached in 59% after VOM-CA and 39.1% after CA (P = .01). Tests for interaction were significant (P = .002 for perimitral block and P = .04 for center volume). Conclusion: Adding VOM ethanol infusion to CA has a greater impact on outcomes when associated with perimitral block and performed in high-volume centers. Perimitral block should be part of the VOM procedure.