Andrea Natale

University of Texas at Austin, Austin, Texas, United States

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Publications (682)4271.65 Total impact

  • Europace 11/2015; DOI:10.1093/europace/euv344 · 3.67 Impact Factor
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    ABSTRACT: Introduction: Left atrial appendage (LAA) can be effectively and safely excluded using a novel percutaneous LARIAT ligation system. However, due to pericardial catheter manipulation and LAA ligation and subsequent necrosis, post-procedural course is complicated by pericarditis. We intended to evaluate the pre-procedural use of colchicine on the incidence of post-procedural pericardial complications. Methods and results: In this multicenter observational study, we included all consecutive patients who underwent LARIAT procedure at the participating centers. Many patients received peri-procedural colchicine at the discretion of the physician. We compared the post-procedural outcomes of patients who received prophylactic peri-procedural colchicine (colchicine group) with those who did not receive colchicine (standard group). A total of 344 consecutive patients, 243 in "colchicine group" and 101 in "standard group" were included. The mean age, median CHADS2VASc score and HASBLED scores were 70±11 years, 3±1.7 and 3±1.1, respectively. There were no significant differences in major baseline characteristics between the two groups. Severe pericarditis was significantly lower in "colchicine group" compared to "standard group" (10 (4 %) vs 16 (16%) p<0.0001). Colchicine group, compared to standard group had lesser pericardial drain output (186±84 ml vs 351±83, p<0.001), shorter pericardial drain duration (16±4 vs 23±19 hours, p<0.04) and similar incidence of delayed pericardial effusion (4 (1.6%) to 3 (3%), p = 0.42) when compared to the standard group. Conclusion: Use of colchicine peri-procedurally was associated with significant reduction in post-procedural pericarditis and associated complications. This article is protected by copyright. All rights reserved.
    Journal of Cardiovascular Electrophysiology 10/2015; DOI:10.1111/jce.12869 · 2.96 Impact Factor

  • Europace 10/2015; DOI:10.1093/europace/euv338 · 3.67 Impact Factor
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    ABSTRACT: Cardioesophageal fistulas (CEFs) are uncommon but life-threatening complications of radiofrequency (RF) catheter ablation of atrial fibrillation (AF). They are usually, but not exclusively, related to ablation of the left atrial posterior wall. We report a case of a 73-year-old man that presented with CEF following RF ablation in the coronary sinus, highlighting the importance of esophageal temperature monitoring whenever ablating in the posterior heart. This article is protected by copyright. All rights reserved
    Journal of Cardiovascular Electrophysiology 10/2015; DOI:10.1111/jce.12831 · 2.96 Impact Factor
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    ABSTRACT: Abstracts and presentations are embargoed for release at date and time of presentation or time of AHA/ASA news event. Failure to honor embargo policies ( will result in the abstract being withdrawn and barred from presentation. Arrhythmias and Electrophysiology Session Title: Treatment of Arrhythmias: Ablation Outcomes Abstract 9955: Outcomes of Catheter Ablation of Atrial Fibrillation in Hypertrophic Cardiomyopathy Patients - A Pooled Analysis Vivek Yarlagadda1; Arun Kanmanthareddy2; Parinita A Dherange3; Pradyumna Agasthi4; Arun Raghav Mahankhali Sridhar5; Sudharani Bommana6; Donita Atkins6; Andrea Natale7; Luigi Di Biase8; Dhanunjaya Lakkireddy5; Madhu Reddy5 + Author Affiliations 1Internal Medicine, AtlantiCare Regional Med Cntr, Atlantic City, NJ 2Cardiology, Creighton Univ Sch of Medicine, Omaha, NE 3Internal Medicine, Banner Univ Med Cntr - South, Tucson, AZ 4Internal Medicine, Morehouse Sch of Medicine, Atlanta, GA 5Cardiology, The Univ of Kansas Med Cntr, Kansas City, KS 6Cardiology, Univ of Kansas Hosp, Kansas City, KS 7Cardiology, Texas Cardiac Arrhtyhmia Institute, Austin, TX 8Cardiology, Montiofiore, New York, NY Abstract Objectives: Atrial fibrillation (AF) is the most common sustained arrhythmia in hypertrophic cardiomyopathy (HCM.) Aggressive rhythm control is recommended for this group of patients and radiofrequency catheter ablation is emerging as a frontline strategy. This pooled analysis aims to study the efficacy and outcomes of AF ablation in HCM patients Methods: PubMed, EMBASE and Google Scholar databases were searched to identify all studies describing the outcomes of catheter ablation of AF in HCM. Data from identified studies was extracted and pooled analysis was carried out using CMA 2 software. Pooled adjusted procedure duration and incident rates of recurrence and adverse events were calculated using random effects model. Results: A total of 11 studies with 384 patients were included in this study. For the index procedure, mean procedural time, radio frequency ablation and fluoroscopy times were 207.3 minutes, 39.7 minutes and 62.4 minutes respectively. The adjusted incidence of major ablation-related complications (death, stroke, transient ischemic attack, peripheral embolism, cardiac tamponade or perforation, valvular damage, arteriovenous fistula requiring surgical intervention, and a large vascular access site hematoma resulting in a drop of hemoglobin level by 2 g/dL) was 4 per 100 procedures (95% CI 2.1 - 7.5%). The recurrence of AF after index ablation during the mean follow up period of 14.5 months occurred in 58% (95% CI 50 -66%) of the patients (Figure1). Conclusion: The results of our analysis suggest that there is a high rate of recurrence of AF in HCM patients who undergo single AF ablation. The risk of complications with AF ablation appears to be low in this group of patients. Further studies are needed to assess the impact of multiple ablations on long term outcomes in these patients.
    AHA 2015; 10/2015
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    ABSTRACT: Background: Balloon catheters have been designed to facilitate pulmonary vein (PV) isolation in patients with paroxysmal atrial fibrillation (AF). The visually guided laser balloon (VGLB) employs laser energy to ablate tissue under direct visual guidance. Objectives: This study compared the efficacy and safety of VGLB ablation with standard irrigated radiofrequency ablation (RFA) during catheter ablation of AF. Methods: Patients with drug-refractory paroxysmal AF were enrolled in a multicenter, randomized controlled study of PV isolation using either the VGLB or RFA (control). The primary efficacy endpoint was freedom from protocol-defined treatment failure at 12 months, including symptomatic AF occurring after the 90-day blanking period. The primary efficacy and safety endpoints were powered for noninferiority. Results: A total of 353 patients (178 VGLB, 175 control) were randomized at 19 clinical sites. The mean procedure, ablation, and fluoroscopy times were longer with VGLB compared with controls. The primary efficacy endpoint was met in 61.1% in the VGLB group versus 61.7% in controls (absolute difference -0.6%; lower limit of 95% confidence interval [CI]: -9.3%; p = 0.003 for noninferiority). The primary adverse event rate was 11.8% in the VGLB group versus 14.5% in controls (absolute difference -2.8%; upper limit of 95% CI: 3.5; p = 0.002 for noninferiority), and was mainly driven by cardioversions. Diaphragmatic paralysis was higher (3.5% vs. 0.6%; p = 0.05), but PV stenosis was lower (0.0% vs. 2.9%; p = 0.03) with VGLB. Conclusions: Despite minimal prior experience, the safety and efficacy of VGLB ablation proved noninferior to RFA for the treatment of paroxysmal AF. (Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System-Adaptive Contact [EAS-AC] [HeartLight] in Patients With Paroxysmal Atrial Fibrillation [PAF] [HeartLight]; NCT01456000).
    Journal of the American College of Cardiology 09/2015; 66(12):1350-60. DOI:10.1016/j.jacc.2015.07.036 · 16.50 Impact Factor
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    ABSTRACT: Introduction: Next generation catheters have been developed to reduce irrigation volume and preserve power delivery. A novel design employs a flexible tip (FlexAbility™ catheter) that directs flow to the contact surface. Due to recent safety issues with new catheters, we undertook a study in a canine heart with three irrigated catheters to compare efficacy and safety. Methods: Endocardial ablation was performed by two independent operators in 12 anesthetized canines with the FlexAbility (St. Jude Medical), ThermoCool™(1) (Biosense Webster), and ThermoCool™ SF (Biosense Webster) catheters. Endocardial RF lesions were delivered with each catheter in all 4 chambers of each animal for 52 ± 16 seconds. Each chamber was randomized to receive ablation from one catheter with recording of safety events. Cardiac pathology was performed with TTC stain. Results: Average lesion dimensions were not significantly different between the three catheters. FlexAbility™ demonstrated a lower risk of steam pops relative to ThermoCool SF (P-value = 0.013) despite equal mean power and RF time. High temperature generator shutdowns were observed with FlexAbility™ but not with either ThermoCool catheter. High temperature shutdowns were associated with larger average impedance drops (28.5 vs 19 ohms) without compromising lesion size. Conclusions: The FlexAbility™ tip is safe and effective with no significant difference in lesions sizes compared to both standard ThermoCool and ThermoCool SF. FlexAbility™ has a significantly lower risk of steam pops compared to ThermoCool SF in a beating heart as defined predominantly by an abrupt rise of impedance. This article is protected by copyright. All rights reserved.
    Journal of Cardiovascular Electrophysiology 09/2015; DOI:10.1111/jce.12835 · 2.96 Impact Factor
  • Ranjan K Thakur · Andrea Natale ·

    Cardiac electrophysiology clinics 09/2015; 7(3):xiii. DOI:10.1016/j.ccep.2015.07.002
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    ABSTRACT: Catheter ablation for inappropriate sinus tachycardia (IST) is recommended for patients symptomatic for palpitations and refractory to other treatments. The current approach consists in sinus node modification (SNM), achieved by ablation of the cranial part of the sinus node to eliminate faster sinus rates while trying to preserve chronotropic competence. This approach has a limited efficacy, with a very modest long-term clinical success. To overcome this, proper patient selection is crucial and an epicardial approach should always be considered. This brief review will discuss the current role and limitations of catheter ablation in the management of patients with IST.
    Journal of Interventional Cardiac Electrophysiology 08/2015; DOI:10.1007/s10840-015-0040-2 · 1.58 Impact Factor
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    ABSTRACT: Whether in patients with paroxysmal atrial fibrillation (PAF) ablation of non-pulmonary vein triggers after antral pulmonary vein isolation (PVAI) improves the long-term outcome in patients with LV systolic dysfunction (LVSD) is unknown. We sought to evaluate whether a more extensive ablation improve outcomes at follow up. Consecutive patients with PAF refractory to AADs presenting for PVAI were prospectively studied. Patients were categorized into 2 groups: Group I patients with LVEF ≤ 35% (N = 175) and Group II patients with LVEF ≥ 50% (N = 545). Patients in Group I were further divided according to whether additional ablation of non-PV triggers was performed (Group IA, N = 88) or not (Group IB, N = 87). Long-term ablation success off AAD after a single procedure was analyzed. Patients in Group I had more non-PV triggers than patients in Group II (69.1% vs. 26.6%; p < 0.001). During a follow-up of 15.8 ± 4.7 months, less patients in Group I remained free from recurrences compared to Group II (53.7% vs. 81.7% p < 0.001). Group IA long-term ablation success was higher compared to Group IB (75.0% vs. 32.2%, p < 0.001), and similar to Group II (75.0% vs. 81.7%, p = 0.44). In the multivariate analysis, LVEF ≤ 35% (hazard ratio [HR], 1.68; p = 0.003), and non-PV triggers (HR, 3.12; p < 0.001) were independent predictors of recurrences. In patients with PAF and LVSD, ablation of non-PV triggers in addition to PVAI significantly improves their long-term outcome. Copyright © 2015. Published by Elsevier Inc.
    Heart rhythm: the official journal of the Heart Rhythm Society 08/2015; DOI:10.1016/j.hrthm.2015.08.029 · 5.08 Impact Factor
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    ABSTRACT: Whether the isolation of LAPW offers additional benefits over PVAI alone in pts with persistent atrial fibrillation (PersAF) is unclear. We sought to determine the impact of PVAI and LA posterior wall isolation (PVAI+LAPW) versus PVAI alone on the outcome of ablation of PersAF. During the 1(st) procedure, PVAI was performed in 20 pts (Group 1) while in 32 pts (Group 2) PVAI was extended to the LA septum and CS and isolation of the LA posterior wall was targeted (ePVAI+LAPW). SVC isolation was achieved in both groups. All 6 pts regardless of arrhythmia recurrence underwent a 2(nd) procedure 3 months after the 1(st) procedure. In pts with reconnection of PVs and/or LAPW, re-isolation was performed and a 3(rd) procedure was performed 3 months later to verify isolation. Pts entered follow-up only after PVAI (Group 1) or PVAI+LAPW (Group 2) isolation was proven. At the 1, 2, 3-year follow-up, the rate of freedom from atrial tachyarrhythmia without anti-arrhythmic drug was 20%, 15% and 10% in Group 1, and 65%, 50% and 40% in Group 2, respectively (log rank p<0.001). The median recurrence-free survival time is 8.5 months (IQR 6.5-11.0) in Group 1 and 28.0 months (IQR 8.5-32.0) in Group 2. Proven isolation of the LAPW provides additional benefits over PVAI alone in the treatment of PersAF and improves procedural outcome at follow-up. However, the ablation strategy of ePVAI+LAPW is still associated with a significant high incidence of very late atrial tachyarrhythmia recurrence. Copyright © 2015. Published by Elsevier Inc.
    Heart rhythm: the official journal of the Heart Rhythm Society 08/2015; DOI:10.1016/j.hrthm.2015.08.019 · 5.08 Impact Factor
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    ABSTRACT: -Contact Force (CF) is a major determinant of lesion size and transmurality, and has the potential to improve efficacy of atrial fibrillation (AF) ablation. This study sought to evaluate the safety and effectiveness of a novel irrigated radiofrequency ablation (RFA) catheter which measures real-time CF in the treatment of patients with paroxysmal AF. -A total of 300 patients with symptomatic, drug-refractory, paroxysmal AF were enrolled in a prospective, multicenter, randomized controlled trial and randomized to RFA with either a novel CF sensing catheter or a non-CF catheter (Control). The primary effectiveness endpoint consisted of acute electrical isolation of all pulmonary veins (PVs) and freedom from recurrent symptomatic atrial arrhythmia off all anti-arrhythmic drugs at 12 months. The primary safety endpoint included device-related serious adverse events. Endpoints were powered to show non-inferiority. All PVs were isolated in both groups. Effectiveness was achieved in 67.8% and 69.4% of subjects in the CF and Control arms, respectively (absolute difference -1.6%, lower limit of one-sided 95% CI -10.7%, p=0.0073 for non-inferiority). When the CF arm was stratified into optimal CF (≥90% ablations with ≥10g) and non-optimal CF groups, effectiveness was achieved in 75.9% vs. 58.1%, respectively (p=0.018). The primary safety endpoint occurred in 1.97% and 1.40% of CF patients and Controls, respectively (absolute difference 0.57%, upper limit of one-sided 95% CI 3.61%, p=0.0004 for non-inferiority). -The CF ablation catheter met the primary safety and effectiveness endpoints. Additionally, optimal CF was associated with improved effectiveness. Clinical Trial Registration; Identifier: NCT01278953.
    Circulation 08/2015; 132(10). DOI:10.1161/CIRCULATIONAHA.114.014092 · 14.43 Impact Factor
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    ABSTRACT: Non-vitamin K antagonist oral anticoagulants (NOACs) are frequently used to prevent stroke in patients with atrial fibrillation. These patients are often also on aspirin or other antiplatelet agents. It is possible that treatment with both NOACs and aspirin or other antiplatelet drug may be effective in decreasing stroke, but data are sparse regarding the efficacy and safety of using both agents for stroke prevention. To address these issues, data were pooled from the four recent randomized controlled trials of NOACs apixaban, rivaroxaban, dabigatran and edoxaban, which included 42,411 patients; 14,148 (33.4%) were also on aspirin or other antiplatelet drug. The number of thromboembolic events among participants on NOAC and aspirin/antiplatelet was compared to the number of events in patients on NOAC alone. Bleeding rates were also compared among those on NOAC + aspirin/antiplatelet to NOAC alone. These results were compared to thromboembolic and bleeding events in the warfarin + aspirin/antiplatelet vs. warfarin alone. No greater risk for thromboembolism was seen in patients on NOACs compared to patients on both NOACs and aspirin/antiplatelet drug. In this non-randomized comparison, there was initially a signal towards higher thromboembolic rates among NOAC users also on aspirin/antiplatelet drugs (RR 1.16; 95% CI 1.05, 1.29) compared to NOAC alone. This likely reflected the higher CHADS2 scores of those on aspirin/antiplatelet drugs. When the analysis was limited to studies that included aspirin rather than other antiplatelet drugs, no difference was seen for thromboembolic rates comparing dual therapy to NOAC alone (RR 1.02; 95% CI 0.90, 1.15). Higher rates of bleeding were seen with aspirin/antiplatelet drug in conjunction with NOAC. In this meta-analysis and nonrandomized comparison of aspirin/antiplatelet users and nonusers also on anticoagulation, there was no additional benefit seen of anticoagulation and antiplatelet therapy for stroke 4 prevention compared to anticoagulation alone. There was, however, an increased risk of bleeding. Careful assessment of the indications for antiplatelet drugs in patients with atrial fibrillation who are also receiving oral anticoagulation is warranted, and future randomized comparisons are needed. Copyright
    Cardiology in Review 08/2015; DOI:10.1097/CRD.0000000000000088 · 2.41 Impact Factor
  • David F Briceno · Andrea Natale · Luigi Di Biase ·
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    ABSTRACT: Catheter ablation of atrial fibrillation (AF) is the standard of care to achieve rhythm control in selected patients who have failed medical therapy. Despite advances in ablation strategies and technology, thromboembolism and bleeding are still important complications of catheter ablation of AF occurring in up to 5% of cases. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.
    Pacing and Clinical Electrophysiology 07/2015; 38(10). DOI:10.1111/pace.12683 · 1.13 Impact Factor
  • Philip Aagaard · Andrea Natale · Luigi Di Biase ·
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    ABSTRACT: Manual radio frequency (RF) ablation to restore a normal cardiac rhythm requires significant skill, manual dexterity and experience. In response to this, ablation methods and technologies have evolved rapidly in the past decade, including the development of remote navigation technologies. Today, two principal methods of remote navigation are available. One utilizes magnetic field vectors to navigate proprietary catheters, the other maneuvers standard catheters robotically. The main advantages of remote navigation include improved catheter stability, reduced fluoroscopy times and decreased total radiation exposure to both the patient and the operator. The main limitations include cost and longer procedure times. Remote magnetic navigation appears to have the best safety profile; however, its efficacy in creating lesions may be lower, which has been attributed to the soft-tip catheter used. Remote robotic navigation on the other hand, which uses regular catheter tips, is associated with a slightly higher overall complication rate, but higher efficacy. This article reviews the pros and cons of remote navigation for ablation of both atrial and ventricular substrates. Finally, it attempts to predict the direction of this field in the coming years.
    Expert Review of Medical Devices 07/2015; 12(4):457-469. DOI:10.1586/17434440.2015.1052406 · 1.68 Impact Factor
  • Mary Mosley · A. Natale · L. Di Biase ·
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    ABSTRACT: In patients with nonvalvular atrial fibrillation who are undergoing catheter ablation, VENTURE AF has shown that uninterrupted rivaroxaban compared with uninterrupted warfarin is associated with a risk of periprocedural thromboembolic events and major bleeding that was similar to that seen with warfarin. An open-label multicenter registry with uninterrupted apixaban vs uninterrupted warfarin yielded the same result.
    07/2015; 15(12):7-8. DOI:10.1177/1559897715593733
  • Jorge Romero · Andrea Natale · Luigi Di Biase ·
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    ABSTRACT: Atrial fibrillation (AF) related cardioembolic cerebrovascular accidents (CVA) are well-known massive health care problems worldwide.(1, 2) It has been estimated that 2.2 million individuals in America and 4.5 million in Europe have paroxysmal or persistent AF.(3) AF is associated with an increased long-term risk of embolic CVA.(4) The rate of stroke among patients with non-valvular AF averages 5% per year.(5-7) Additionally, the prevalence of AF and the associated risk of ischemic stroke might be to a large extent underestimated given that AF is frequently asymptomatic and undiagnosed.(8) This was corroborated by a recent study, which revealed that subclinical atrial tachyarrhythmias without clinical AF occurred often in patients with pacemakers and were linked to a greater risk of ischemic stroke or systemic embolism.(9) Moreover, prolonged cardiac monitoring with 30-day event monitor or implantable loop recorders has dramatically increased the connection between AF and the so-called "cryptogenic stroke" by a factor of five and double the rate of anticoagulant treatment.(10, 11) This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.
    Journal of Cardiovascular Electrophysiology 06/2015; 26(9). DOI:10.1111/jce.12746 · 2.96 Impact Factor
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    ABSTRACT: Previous studies reported the usefulness of an irrigated circular radiofrequency ablation catheter (nMARQ(TM), Biosense Webster) for pulmonary vein isolation (PVI). We evaluated the role of intracardiac echocardiography (ICE) to optimize the manipulation of nMARQ(TM) catheter. Thirty-seven patients (pts), (mean age 55 ± 12 years; 28 males) were enrolled to perform PVI. All pts underwent PVI with the nMARQ(TM) catheter. In 20 pts (group 1), we utilized ICE to guide nMARQ(TM) catheter positioning at the PV ostia; in the other 17 pts (group 2), nMARQ(TM) catheter was positioned at the PV ostia guided by fluoroscopy and TissueConnect(TM) technology. Radiofrequency (RF) applications were significantly lower in group 1 compared to group 2 [left PVs: 6 (range 3 to 12) in group 1 and 12 (range 5 to 16) in group 2 (p < 0.001); right PVs: 7 (range 4 to 14) in group 1 and 10 (range 5 to 16) in group 2 (p = 0.04)]; similarly regarding the time of RF delivery [left PVs: 318 ± 194 s in group 1 vs. 542 ± 104 s in group 2 (p < 0.001); right PVs: 410 ± 270 s in group 1 vs. 550 ± 156 s in group 2 (p = 0.05)]. Fluoroscopy time (23 ± 9 min vs. 28 ± 5 min; p = 0.05), procedural time (83 ± 23 min vs. 160 ± 42 min; p < 0.001), and radiation dose (109 ± 20 Gy/cm(2) vs. 127 ± 29 Gy/cm(2); p = 0.04) were significantly lower in group 1 compared to group 2. ICE might be a useful tool to guide nMARQ(TM) catheter position in the left atrium during atrial fibrillation (AF) ablation procedures.
    Journal of Interventional Cardiac Electrophysiology 06/2015; 44(1). DOI:10.1007/s10840-015-0026-0 · 1.58 Impact Factor
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    ABSTRACT: -A "dry" epicardial access (EA) is increasingly used for advanced cardiovascular procedures. Conventionally used large bore needles (Tuohy or Pajunk needle; LBN) have been associated with low but definite incidence of major complications with EA. Use of micropuncture needle (MPN) may decrease the risk of complications. We intended to compare the outcomes of LBN with MPN for EA. -We report a multicenter observational study of consecutive patients who underwent EA for ventricular tachycardia (VT) ablation or lariat procedure using the LBN or MPN. Oral anticoagulation was stopped prior to the procedure. Baseline characteristics and procedure related complications were collected and compared. Of the 404 patients, LBN and MPN was used in 46% and 54% of patients respectively. There was no significant difference in the incidence of inadvertent puncture of myocardium between LBN and MPN needle (7.6% vs 6.8%, p=0.76). However, there was a significantly higher rate of large pericardial effusions with LBN compared to MPN (8.1% vs 0.9%: p<0.001). The incidence of pleural effusions were not significantly different between both (1.6% vs 2.3%, p=0.64). LBN group had an increase in "other complications" compared to MP (open heart surgery to repair cardiac laceration (6 vs 0), injury to liver (1vs 0), coronaries (1 vs 0) and superior epigastric artery requiring surgical exploration (0 vs 1). -The use of MPN is associated with decreased incidence of major complications and the need for surgical repair and routine use should be considered for EA.
    Circulation Arrhythmia and Electrophysiology 06/2015; 8(4). DOI:10.1161/CIRCEP.115.002921 · 4.51 Impact Factor
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    ABSTRACT: Visually-guided laser balloon (VGLB) ablation is unique in that the operator delivers ablative energy under direct visual guidance. In this multicenter study, we sought to determine the feasibility, efficacy, and safety of performing pulmonary vein isolation (PVI) using this VGLB. Patients with symptomatic, drug-refractory paroxysmal atrial fibrillation (AF) underwent PVI using the VGLB with the majority of operators conducting their first-ever clinical VGLB cases. The primary effectiveness endpoint was defined as freedom from treatment failure that included: occurrence of symptomatic AF episodes ≥1 min beyond the 90-day blanking, the inability to isolate one superior and two total PVs, occurrence of left atrial flutter or atrial tachycardia, or left atrial ablation/surgery during follow-up. A total of 86 patients (mean age 56±10 years, 67% male) were treated with the VGLB at 10 US centers. Mean fluoroscopy, ablation, and procedure times were 39.8±24.3 min, 205.2±61.7 min, and 253.5±71.3 min, respectively. Acute PVI was achieved in 314/323 (97.2%) of targeted PVs. Of 84 patients completing follow-up, the primary effectiveness endpoint was achieved in 50 (60%) patients. Freedom from symptomatic or asymptomatic AF was 61%. The primary adverse event rate was 16.3% (8.1% pericarditis, phrenic nerve injury 5.8%, and cardiac tamponade 3.5%). There were no cerebrovascular events, atrioesophageal fistulas, or significant PV stenosis. This multicenter study of operators in the early stage of the learning curve demonstrates that PVI can be achieved with the VGLB with a reasonable safety profile and an efficacy similar to radiofrequency ablation. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.
    Journal of Cardiovascular Electrophysiology 06/2015; 26(9). DOI:10.1111/jce.12727 · 2.96 Impact Factor

Publication Stats

20k Citations
4,271.65 Total Impact Points


  • 2009-2015
    • University of Texas at Austin
      • Department of Biomedical Engineering
      Austin, Texas, United States
  • 2008-2015
    • Stanford University
      Palo Alto, California, United States
    • St. David's North Austin Medical Center
      Austin, Texas, United States
  • 2014
    • University of Florence
      • Dipartimento di Chirurgia e Medicina Traslazionale (DCMT)
      Florens, Tuscany, Italy
    • University of Rome Tor Vergata
      Roma, Latium, Italy
    • Texas Heart Institute
      Houston, Texas, United States
    • Kansas City VA Medical Center
      Kansas City, Missouri, United States
    • Case Western Reserve University
      Cleveland, Ohio, United States
  • 2011-2014
    • Michigan State University
      • Thoracic and Cardiovascular Institute
      East Lansing, Michigan, United States
  • 2013
    • California Pacific Medical Center Research Institute
      San Francisco, California, United States
  • 2000-2013
    • Cleveland Clinic
      • • Center for Atrial Fibrillation
      • • Department of Cardiovascular Medicine
      • • Department of Cardiology
      Cleveland, Ohio, United States
  • 2012
    • Southlake Regional Health Centre
      Bradford West Gwillimbury, Ontario, Canada
    • Ospedale Luigi Sacco
      Milano, Lombardy, Italy
  • 1998-2012
    • University of Kentucky
      • Department of Medicine
      Lexington, Kentucky, United States
    • University of Nebraska Medical Center
      • Department of Internal Medicine
      Omaha, Nebraska, United States
  • 2008-2010
    • Università degli studi di Foggia
      Foggia, Apulia, Italy
  • 2007
    • Cleveland Clinic Laboratories
      Cleveland, Ohio, United States
    • Taipei Veterans General Hospital
      • Cardiology Division
      T’ai-pei, Taipei, Taiwan
    • Johns Hopkins Medicine
      • Division of Cardiology
      Baltimore, Maryland, United States
  • 2006
    • Spokane VA Medical Center
      Spokane, Washington, United States
    • Marin General Hospital
      San Rafael, California, United States
  • 1995-2006
    • Duke University Medical Center
      • • Division of Cardiology
      • • Department of Medicine
      Durham, NC, United States
    • Duke University
      Durham, North Carolina, United States
  • 1990-2006
    • Catholic University of the Sacred Heart
      • Institute of Cardiology
      Milano, Lombardy, Italy
  • 2003
    • Massachusetts General Hospital
      • Division of Cardiology
      Boston, Massachusetts, United States
  • 2001
    • Our Lady of Lourdes Hospital
      Camden, New Jersey, United States
  • 1991-1997
    • The University of Western Ontario
      • Department of Medicine
      London, Ontario, Canada
    • Robarts Research Institute
      London, Ontario, Canada
  • 1994-1995
    • University of Wisconsin - Milwaukee
      Milwaukee, Wisconsin, United States
  • 1989-1993
    • The Catholic University of America
      Washington, Washington, D.C., United States