Ablation Catheter

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Vivek Y. Reddy - One of the best experts on this subject based on the ideXlab platform.

  • safety of Catheter Ablation of atrial fibrillation using fiber optic based contact force sensing
    Heart Rhythm, 2017
    Co-Authors: Moussa Mansour, Vivek Y. Reddy, Dhanunjaya Lakkireddy, Douglas L Packer, John D Day, Srijoy Mahapatra, Kyle J Brunner, Andrea Natale
    Abstract:

    Background While the body of evidence showing the benefit of contact force (CF)–sensing Catheters in improving atrial fibrillation Ablation success rate is growing, real-world safety data of this technology are limited. Objective The aim of this study was to report the complication rate in patients undergoing Ablation using a specific CF-sensing Catheter (TactiCath Quartz CF Ablation Catheter, Abbott, St. Paul, MN) in a large worldwide database. Methods User-reported adverse event data from January 1, 2014 to December 31, 2015 were reviewed for the Ablation Catheter. These adverse events included cardiac perforation, cerebrovascular accident, atrioesophageal (AE) fistula, steam pop, and death. Rates of these adverse events, including geographic and temporal relationships, were calculated. Results Adverse events were reported in 178 of 41,709 patients (adverse event rate 0.427%). Adverse events included 117 cardiac perforations (0.281%), 5 cerebrovascular accidents (0.012%), 10 AE fistulas (0.024%), 53 audible steam pops (0.127%), and 13 deaths (0.031%). The total event rate in European countries was 0.53% vs 0.38% in the United States ( P = .0082). The AE fistula event rate peaked in late 2014 and early 2015 at 0.06% and decreased over time to a steady-state 0.01%, corresponding to the initial US release, subsequent increased use, and training on the manufacturer recommended settings. Conclusion Complication rates while using the TactiCath CF Ablation Catheter appear to decrease with training and experience. The major complication rate associated with this technology is low in the context of similar reports of conventional radiofrequency Catheters.

  • abstract 19168 lesion characteristics using a novel multi electrode radiofrequency balloon Ablation Catheter
    Circulation, 2016
    Co-Authors: Amin Alahmad, Vivek Y. Reddy, Karl-heinz Kuck, Marian K Rippy, Girish Narayan, Ian G Crozier, Matthew Daly, Iain Melton, Tomas E Walters, Nitish Badhwar
    Abstract:

    Introduction: Conventional pulmonary vein (PV) isolation for atrial fibrillation (AF) is achieved with point-by-point radiofrequency (RF) Ablation which has challenges. To address these challenges, we evaluated a novel multi-electrode RF balloon Catheter (Apama, Inc., Campbell, CA) that has irrigated electrodes on the surface of the balloon which both map and ablate, and real-time visualization of electrode contact and lesion formation. Hypothesis: We tested this novel Catheter in animals to characterize lesion formation with the goal of transmural lesions. Methods: In five (5) Yorkshire pigs, the novel balloon Catheter was delivered over-the-wire through a steerable sheath to the left atrium. The camera within the balloon provided verification of the electrode position and apposition to tissue. Bipolar Ablation was delivered via selected electrodes at the antrum of targeted pulmonary veins. Ablation lesions and surrounding structures were examined post-staining. Results: In five (5) pigs treated, Ablation lesions were all transmural, 1-5mm in depth. No endocardial thrombus or complications were observed. Surrounding structures including the lungs had no collateral damage. Conclusion: Transmural lesions encircling the PVs were achieved using the multi-electrode RF balloon Ablation Catheter. Real time visualization provided direct feedback on electrode apposition, allowing immediate balloon adjustment without excessive manipulation. From this initial experience, human application of this technology is underway.

  • randomized controlled trial of the safety and effectiveness of a contact force sensing irrigated Catheter for Ablation of paroxysmal atrial fibrillation results of the tacticath contact force Ablation Catheter study for atrial fibrillation toccastar
    Circulation, 2015
    Co-Authors: Vivek Y. Reddy, Petr Neuzil, Andrea Natale, Josef Kautzner, Srinivas R Dukkipati, Jean Paul Albenque, Dipen C Shah, Gregory F Michaud, Marcus Wharton, David Harari
    Abstract:

    Background— Contact force (CF) is a major determinant of lesion size and transmurality and has the potential to improve efficacy of atrial fibrillation Ablation. This study sought to evaluate the safety and effectiveness of a novel irrigated radiofrequency Ablation Catheter that measures real-time CF in the treatment of patients with paroxysmal atrial fibrillation. Methods and Results— A total of 300 patients with symptomatic, drug-refractory, paroxysmal atrial fibrillation were enrolled in a prospective, multicenter, randomized, controlled trial and randomized to radiofrequency Ablation with either a novel CF-sensing Catheter or a non-CF Catheter (control). The primary effectiveness end point consisted of acute electrical isolation of all pulmonary veins and freedom from recurrent symptomatic atrial arrhythmia off all antiarrhythmic drugs at 12 months. The primary safety end point included device-related serious adverse events. End points were powered to show noninferiority. All pulmonary veins 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 1-sided 95% confidence interval, −10.7%; P =0.0073 for noninferiority). When the CF arm was stratified into optimal CF (≥90% Ablations with ≥10 g) and nonoptimal CF groups, effectiveness was achieved in 75.9% versus 58.1%, respectively ( P =0.018). The primary safety end point occurred in 1.97% and 1.40% of CF patients and control subjects, respectively (absolute difference, 0.57%; upper limit of 1-sided 95% confidence interval, 3.61%; P =0.0004 for noninferiority). Conclusions— The CF Ablation Catheter met the primary safety and effectiveness end points. Additionally, optimal CF was associated with improved effectiveness. Clinical Trial Registration— . Unique identifier: [NCT01278953][1]. # CLINICAL PERSPECTIVE {#article-title-23} [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01278953&atom=%2Fcirculationaha%2F132%2F10%2F907.atom

  • randomized controlled trial of the safety and effectiveness of a contact force sensing irrigated Catheter for Ablation of paroxysmal atrial fibrillation results of the tacticath contact force Ablation Catheter study for atrial fibrillation toccastar
    Circulation, 2015
    Co-Authors: Vivek Y. Reddy, Petr Neuzil, Dipen Shah, Andrea Natale, Josef Kautzner, Srinivas R Dukkipati, Jean Paul Albenque, Gregory F Michaud, Marcus Wharton, David Harari
    Abstract:

    Background—Contact force (CF) is a major determinant of lesion size and transmurality and has the potential to improve efficacy of atrial fibrillation Ablation. This study sought to evaluate the safety and effectiveness of a novel irrigated radiofrequency Ablation Catheter that measures real-time CF in the treatment of patients with paroxysmal atrial fibrillation. Methods and Results—A total of 300 patients with symptomatic, drug-refractory, paroxysmal atrial fibrillation were enrolled in a prospective, multicenter, randomized, controlled trial and randomized to radiofrequency Ablation with either a novel CF-sensing Catheter or a non-CF Catheter (control). The primary effectiveness end point consisted of acute electrical isolation of all pulmonary veins and freedom from recurrent symptomatic atrial arrhythmia off all antiarrhythmic drugs at 12 months. The primary safety end point included device-related serious adverse events. End points were powered to show noninferiority. All pulmonary veins were isolat...

  • a novel radiofrequency Ablation Catheter using contact force sensing toccata study
    Heart Rhythm, 2012
    Co-Authors: Karl-heinz Kuck, Vivek Y. Reddy, Boris Schmidt, Petr Neuzil, Andrea Natale, Nadir Saoudi, Josef Kautzner, Claudia Herrera, Gerhard Hindricks, Pierre Jais
    Abstract:

    Objectives The aim of this multicenter study was to evaluate the device- and procedure-related safety of a novel force-sensing radiofrequency (RF) Ablation Catheter capable of measuring the real-time contact force (CF) and to present CF data and its possible implications on patient safety. Background The clinical outcome of RF Ablation for the treatment of cardiac arrhythmias may be affected by the CF between the Catheter tip and the tissue. Insufficient CF may result in an ineffective lesion, whereas excessive CF may result in complications. Methods Seventy-seven patients (43 with right-sided supraventricular tachycardia [SVT] and 34 with atrial fibrillation [AF]) received percutaneous Ablation with the novel studied Catheter. The CF applied and safety events related to the procedure were reported. Results CF values at mapping ranged from 8 ± 8 to 60 ± 35 g and from 12 ± 10 to 39 ± 29 g in the SVT group and the LA group, respectively, showing a significant interinvestigator variability (P 100 g) were noted in 27 patients (79%) of the LA group. One device-related complication (tamponade, 3%) occurred in the AF group. Conclusions Catheter Ablation using real-time CF technology is safe for the treatment of SVT and AF. High CFs may occur during Catheter manipulation and not just during Ablation, suggesting that measuring CF may provide additional useful information to the operator for safe Catheter manipulation. In the future, CF-sensing Catheters may also increase the effectiveness of RF Ablations by allowing better control of the RF lesion size.

Elad Anter - One of the best experts on this subject based on the ideXlab platform.

  • expandable lattice electrode Ablation Catheter
    Circulation-arrhythmia and Electrophysiology, 2019
    Co-Authors: Michael Barkagan, Eran Leshem, Markus Rottmann, Jakub Sroubek, Ayelet Shapiradaniels, Elad Anter
    Abstract:

    Background: High-current short-duration radiofrequency energy delivery has potential advantages for cardiac Ablation. However, this strategy is limited by high current density and narrow safety-to-...

  • evaluation of Ablation Catheter technology comparison between thigh preparation model and an in vivo beating heart
    Heart Rhythm, 2017
    Co-Authors: Eran Leshem, Cory M Tschabrunn, Fernando M Contrerasvaldes, Israel Zilberman, Elad Anter
    Abstract:

    Background An in vivo animal thigh model is the standard technique for evaluation of Ablation Catheter technologies, including efficacy and safety of Ablation. However, the biophysics of Ablation in a thigh model may not be similar to a beating heart. Objective The purpose of this study was to compare efficacy and safety of Ablation between a thigh preparation model and a beating heart. Methods In 7 swine, radiofrequency Ablation using a 3.5-mm open irrigated Catheter (ThermoCool Smart Touch) was performed sequentially in a thigh muscle and in vivo beating ventricles. Ablation was performed at low (30 W for 40 s) and high (40 W for 60 s) energy settings and at similar contact force. Ablation lesions were scanned in high resolution and measured using electronic calipers. Results A total of 152 radiofrequency Ablation lesions were measured (86 thigh and 66 heart). At low energy, lesion width was greater in the thigh model (12.19 ± 1.8 mm vs 8.99 ± 2.1 mm; P P  = .18). The planar cross-sectional lesion area was greater in the thigh model (thigh 54.8 ± 10.8 mm 2 vs heart 43.1 ± 16.1 mm 2 ; P 2 vs heart 56.0 ± 15.5 mm 2 ; P Conclusion The thigh preparation model is a reasonable technique for evaluation of Ablation Catheter technology; however it often results in overestimation of lesion size, especially at higher energy settings.

  • abstract 20614 evaluation of Ablation Catheter technology comparison between the thigh preparation model and an in vivo beating heart
    Circulation, 2016
    Co-Authors: Eran Leshem, Cory M Tschabrunn, Israel Zilberman, Elad Anter
    Abstract:

    Background: An in-vivo animal thigh model is the standard technique for evaluation of Ablation Catheter technologies, including for prediction of Ablation efficacy (lesion dimensions) and safety (cardiac tissue perforation and collateral damage). However, validation of this model with an in-vivo beating heart has not been performed. The purpose of this study was to prospectively compare these two methods. Methods: In 5 Yorkshire swine, radiofrequency Ablation using a 3.5mm open irrigated Catheter (Thermocool Smart Touch®) was performed sequentially in the thigh muscle and the beating ventricles. Ablation was performed in 2 settings: 30W for 40Ssec (low energy) and 40W for 60Sec (high energy) at similar tissue contact (8-14 grams). Tetrazolium chloride was injected 15 minutes prior to euthanasia and all tissue were fixed in formalin for ≥7 days. Ablation lesions were scanned in high-resolution and measured using electronic calipers. Results: A total of 114 RF Ablation lesions were measured (57 for each method). In the low energy setting, lesion width was greater in the thigh model (8.37±1.5mm vs. 7.14±1.3mm; p=0.005) while lesion depth was greater in the beating heart (4.72±0.8mm vs. 4.2±0.6mm; p=0.016). The overall lesion volume was similar between the methods (thigh 27.8±7.1mm 2 vs. heart 26.9±7.9mm 2 ; p=0.74). In the high energy setting, lesion depth, width, and overall volume were greater in the thigh lesions (thigh 53.9±10.8mm 2 vs. heart 34.5±9.6mm 2 ; p=0.001). The thigh model demonstrated consistent and predictable lesions compared to the beating heart (r=0.75 vs r=0.53, respectively). There was no difference in steam pop incidence. Conclusion: The thigh model is a reasonable technique for evaluation of Ablation Catheter technology. The correlation of lesion dimensions between thigh model and beating heart is reasonable in low energy settings, however results in overestimation at higher energy setting. Caution should be taken before extrapolation of Ablation data obtained using the thigh model technique to the beating heart physiology.

Eran Leshem - One of the best experts on this subject based on the ideXlab platform.

  • expandable lattice electrode Ablation Catheter
    Circulation-arrhythmia and Electrophysiology, 2019
    Co-Authors: Michael Barkagan, Eran Leshem, Markus Rottmann, Jakub Sroubek, Ayelet Shapiradaniels, Elad Anter
    Abstract:

    Background: High-current short-duration radiofrequency energy delivery has potential advantages for cardiac Ablation. However, this strategy is limited by high current density and narrow safety-to-...

  • evaluation of Ablation Catheter technology comparison between thigh preparation model and an in vivo beating heart
    Heart Rhythm, 2017
    Co-Authors: Eran Leshem, Cory M Tschabrunn, Fernando M Contrerasvaldes, Israel Zilberman, Elad Anter
    Abstract:

    Background An in vivo animal thigh model is the standard technique for evaluation of Ablation Catheter technologies, including efficacy and safety of Ablation. However, the biophysics of Ablation in a thigh model may not be similar to a beating heart. Objective The purpose of this study was to compare efficacy and safety of Ablation between a thigh preparation model and a beating heart. Methods In 7 swine, radiofrequency Ablation using a 3.5-mm open irrigated Catheter (ThermoCool Smart Touch) was performed sequentially in a thigh muscle and in vivo beating ventricles. Ablation was performed at low (30 W for 40 s) and high (40 W for 60 s) energy settings and at similar contact force. Ablation lesions were scanned in high resolution and measured using electronic calipers. Results A total of 152 radiofrequency Ablation lesions were measured (86 thigh and 66 heart). At low energy, lesion width was greater in the thigh model (12.19 ± 1.8 mm vs 8.99 ± 2.1 mm; P P  = .18). The planar cross-sectional lesion area was greater in the thigh model (thigh 54.8 ± 10.8 mm 2 vs heart 43.1 ± 16.1 mm 2 ; P 2 vs heart 56.0 ± 15.5 mm 2 ; P Conclusion The thigh preparation model is a reasonable technique for evaluation of Ablation Catheter technology; however it often results in overestimation of lesion size, especially at higher energy settings.

  • abstract 20614 evaluation of Ablation Catheter technology comparison between the thigh preparation model and an in vivo beating heart
    Circulation, 2016
    Co-Authors: Eran Leshem, Cory M Tschabrunn, Israel Zilberman, Elad Anter
    Abstract:

    Background: An in-vivo animal thigh model is the standard technique for evaluation of Ablation Catheter technologies, including for prediction of Ablation efficacy (lesion dimensions) and safety (cardiac tissue perforation and collateral damage). However, validation of this model with an in-vivo beating heart has not been performed. The purpose of this study was to prospectively compare these two methods. Methods: In 5 Yorkshire swine, radiofrequency Ablation using a 3.5mm open irrigated Catheter (Thermocool Smart Touch®) was performed sequentially in the thigh muscle and the beating ventricles. Ablation was performed in 2 settings: 30W for 40Ssec (low energy) and 40W for 60Sec (high energy) at similar tissue contact (8-14 grams). Tetrazolium chloride was injected 15 minutes prior to euthanasia and all tissue were fixed in formalin for ≥7 days. Ablation lesions were scanned in high-resolution and measured using electronic calipers. Results: A total of 114 RF Ablation lesions were measured (57 for each method). In the low energy setting, lesion width was greater in the thigh model (8.37±1.5mm vs. 7.14±1.3mm; p=0.005) while lesion depth was greater in the beating heart (4.72±0.8mm vs. 4.2±0.6mm; p=0.016). The overall lesion volume was similar between the methods (thigh 27.8±7.1mm 2 vs. heart 26.9±7.9mm 2 ; p=0.74). In the high energy setting, lesion depth, width, and overall volume were greater in the thigh lesions (thigh 53.9±10.8mm 2 vs. heart 34.5±9.6mm 2 ; p=0.001). The thigh model demonstrated consistent and predictable lesions compared to the beating heart (r=0.75 vs r=0.53, respectively). There was no difference in steam pop incidence. Conclusion: The thigh model is a reasonable technique for evaluation of Ablation Catheter technology. The correlation of lesion dimensions between thigh model and beating heart is reasonable in low energy settings, however results in overestimation at higher energy setting. Caution should be taken before extrapolation of Ablation data obtained using the thigh model technique to the beating heart physiology.

Cory M Tschabrunn - One of the best experts on this subject based on the ideXlab platform.

  • evaluation of Ablation Catheter technology comparison between thigh preparation model and an in vivo beating heart
    Heart Rhythm, 2017
    Co-Authors: Eran Leshem, Cory M Tschabrunn, Fernando M Contrerasvaldes, Israel Zilberman, Elad Anter
    Abstract:

    Background An in vivo animal thigh model is the standard technique for evaluation of Ablation Catheter technologies, including efficacy and safety of Ablation. However, the biophysics of Ablation in a thigh model may not be similar to a beating heart. Objective The purpose of this study was to compare efficacy and safety of Ablation between a thigh preparation model and a beating heart. Methods In 7 swine, radiofrequency Ablation using a 3.5-mm open irrigated Catheter (ThermoCool Smart Touch) was performed sequentially in a thigh muscle and in vivo beating ventricles. Ablation was performed at low (30 W for 40 s) and high (40 W for 60 s) energy settings and at similar contact force. Ablation lesions were scanned in high resolution and measured using electronic calipers. Results A total of 152 radiofrequency Ablation lesions were measured (86 thigh and 66 heart). At low energy, lesion width was greater in the thigh model (12.19 ± 1.8 mm vs 8.99 ± 2.1 mm; P P  = .18). The planar cross-sectional lesion area was greater in the thigh model (thigh 54.8 ± 10.8 mm 2 vs heart 43.1 ± 16.1 mm 2 ; P 2 vs heart 56.0 ± 15.5 mm 2 ; P Conclusion The thigh preparation model is a reasonable technique for evaluation of Ablation Catheter technology; however it often results in overestimation of lesion size, especially at higher energy settings.

  • abstract 20614 evaluation of Ablation Catheter technology comparison between the thigh preparation model and an in vivo beating heart
    Circulation, 2016
    Co-Authors: Eran Leshem, Cory M Tschabrunn, Israel Zilberman, Elad Anter
    Abstract:

    Background: An in-vivo animal thigh model is the standard technique for evaluation of Ablation Catheter technologies, including for prediction of Ablation efficacy (lesion dimensions) and safety (cardiac tissue perforation and collateral damage). However, validation of this model with an in-vivo beating heart has not been performed. The purpose of this study was to prospectively compare these two methods. Methods: In 5 Yorkshire swine, radiofrequency Ablation using a 3.5mm open irrigated Catheter (Thermocool Smart Touch®) was performed sequentially in the thigh muscle and the beating ventricles. Ablation was performed in 2 settings: 30W for 40Ssec (low energy) and 40W for 60Sec (high energy) at similar tissue contact (8-14 grams). Tetrazolium chloride was injected 15 minutes prior to euthanasia and all tissue were fixed in formalin for ≥7 days. Ablation lesions were scanned in high-resolution and measured using electronic calipers. Results: A total of 114 RF Ablation lesions were measured (57 for each method). In the low energy setting, lesion width was greater in the thigh model (8.37±1.5mm vs. 7.14±1.3mm; p=0.005) while lesion depth was greater in the beating heart (4.72±0.8mm vs. 4.2±0.6mm; p=0.016). The overall lesion volume was similar between the methods (thigh 27.8±7.1mm 2 vs. heart 26.9±7.9mm 2 ; p=0.74). In the high energy setting, lesion depth, width, and overall volume were greater in the thigh lesions (thigh 53.9±10.8mm 2 vs. heart 34.5±9.6mm 2 ; p=0.001). The thigh model demonstrated consistent and predictable lesions compared to the beating heart (r=0.75 vs r=0.53, respectively). There was no difference in steam pop incidence. Conclusion: The thigh model is a reasonable technique for evaluation of Ablation Catheter technology. The correlation of lesion dimensions between thigh model and beating heart is reasonable in low energy settings, however results in overestimation at higher energy setting. Caution should be taken before extrapolation of Ablation data obtained using the thigh model technique to the beating heart physiology.

  • percutaneous epicardial ventricular tachycardia Ablation after noncoronary cardiac surgery or pericarditis
    Heart Rhythm, 2013
    Co-Authors: Cory M Tschabrunn, Edward P. Gerstenfeld, Sanjay Dixit, David J. Callans, Joshua M Cooper, Haris M Haqqani, Fermin C Garcia, Erica S Zado, Francis E. Marchlinski
    Abstract:

    Background Patients with previous noncoronary cardiac surgery or pericarditis may require epicardial access to facilitate successful ventricular tachycardia (VT) Ablation. Percutaneous pericardial access is known to be difficult in these patients owing to the presence of pericardial adhesions. Objective To examine the success and safety of percutaneous pericardial access as well as the ability to map and ablate epicardial VT targets. Methods We studied 10 consecutive patients with prior noncoronary cardiac surgery (8 patients) or prior pericarditis (2 patients) who required epicardial access for VT Ablation. Results Percutaneous pericardial access was achieved by experienced operators, and dense adhesions interfering with Catheter mapping were encountered in all patients. Using blunt dissection with a deflected Ablation Catheter, adhesions were divided over the course of 19–125 minutes (mean 57±38 minutes; median 47 minutes). This dissection allowed for sufficient epicardial mapping in 9 of 10 (90%) patients. The clinical targeted VTs were rendered noninducible in 8 (80%) patients. One patient had 70 cm 3 of bleeding with the initial puncture. No other complications occurred. During a long-term follow-up of 24±27 months (median 13 months), 5 patients have remained VT-free. Conclusions Percutaneous pericardial access for epicardial VT Ablation in patients with previous noncoronary cardiac surgery or pericarditis can usually be obtained. However, dense pericardial adhesions are often encountered and may limit the ability to map the entire epicardial space. Typically, appropriate targets can be reached and ablated by disrupting the adhesions with the Ablation Catheter and/or deflectable sheath, facilitating excellent long-term clinical outcome in half of the patients with no major complications.

Israel Zilberman - One of the best experts on this subject based on the ideXlab platform.

  • safety and efficacy of delivering high power short duration radiofrequency Ablation lesions utilizing a novel temperature sensing technology
    Europace, 2018
    Co-Authors: Jeremy N Ruskin, Israel Zilberman, Guy Rozen, Leon M Ptaszek, Victoria Douglas, Kevin E Heist, Christopher Thomas Beeckler, Andres Claudio Altmann, Assaf Govari
    Abstract:

    Aims Delivery of high-power short-duration radiofrequency (RF) Ablation lesions is not commonly used, in part because conventional thermocouple (TC) technology underestimates tissue temperature, increasing the risk of steam pop, and thrombus formation. We aimed to test whether utilization of an Ablation Catheter equipped with a highly accurate novel TC technology could facilitate safe and effective delivery of high-power RF lesions. Methods and results Adult male Yorkshire swine were used for the study. High-power short-duration Ablations (10-s total; 90 W for 4 s followed by 50 W for 6 s) were delivered using an irrigated force sensing Catheter, equipped with six miniature TC sensors embedded in the tip electrode shell. Power modulation was automatically performed when the temperature reached 65°C. Ablation parameters were recorded and histopathological analysis was performed to assess lesion formation. One hundred and fourteen RF applications, delivered using the study Ablation protocol in the ventricles of eight swine [53 in the right ventricle (RV), 61 in the left ventricle (LV)], were analysed. Average power delivered was 55.4 ± 5.3 W and none of the Ablations resulted in a steam pop. Fourteen out of the 114 (12.3%) lesions were transmural. The mean lesion depth was 3.9 ± 1.1 mm for the 100 non-transmural lesions. Similar Ablation parameters resulted in bigger impedance drop (11.6 Ω vs. 9.1 Ω, P = 0.009) and deeper lesions in the LV compared with the RV (4.3 ± 1.2 mm vs. 3.3 ± 0.8 mm, P < 0.001). Conclusion Delivery of high-power short-duration RF energy applications, facilitated by a novel Ablation Catheter system equipped with advanced TC technology, is feasible, safe, and results in the formation of effective Ablation lesions.

  • evaluation of Ablation Catheter technology comparison between thigh preparation model and an in vivo beating heart
    Heart Rhythm, 2017
    Co-Authors: Eran Leshem, Cory M Tschabrunn, Fernando M Contrerasvaldes, Israel Zilberman, Elad Anter
    Abstract:

    Background An in vivo animal thigh model is the standard technique for evaluation of Ablation Catheter technologies, including efficacy and safety of Ablation. However, the biophysics of Ablation in a thigh model may not be similar to a beating heart. Objective The purpose of this study was to compare efficacy and safety of Ablation between a thigh preparation model and a beating heart. Methods In 7 swine, radiofrequency Ablation using a 3.5-mm open irrigated Catheter (ThermoCool Smart Touch) was performed sequentially in a thigh muscle and in vivo beating ventricles. Ablation was performed at low (30 W for 40 s) and high (40 W for 60 s) energy settings and at similar contact force. Ablation lesions were scanned in high resolution and measured using electronic calipers. Results A total of 152 radiofrequency Ablation lesions were measured (86 thigh and 66 heart). At low energy, lesion width was greater in the thigh model (12.19 ± 1.8 mm vs 8.99 ± 2.1 mm; P P  = .18). The planar cross-sectional lesion area was greater in the thigh model (thigh 54.8 ± 10.8 mm 2 vs heart 43.1 ± 16.1 mm 2 ; P 2 vs heart 56.0 ± 15.5 mm 2 ; P Conclusion The thigh preparation model is a reasonable technique for evaluation of Ablation Catheter technology; however it often results in overestimation of lesion size, especially at higher energy settings.

  • abstract 20614 evaluation of Ablation Catheter technology comparison between the thigh preparation model and an in vivo beating heart
    Circulation, 2016
    Co-Authors: Eran Leshem, Cory M Tschabrunn, Israel Zilberman, Elad Anter
    Abstract:

    Background: An in-vivo animal thigh model is the standard technique for evaluation of Ablation Catheter technologies, including for prediction of Ablation efficacy (lesion dimensions) and safety (cardiac tissue perforation and collateral damage). However, validation of this model with an in-vivo beating heart has not been performed. The purpose of this study was to prospectively compare these two methods. Methods: In 5 Yorkshire swine, radiofrequency Ablation using a 3.5mm open irrigated Catheter (Thermocool Smart Touch®) was performed sequentially in the thigh muscle and the beating ventricles. Ablation was performed in 2 settings: 30W for 40Ssec (low energy) and 40W for 60Sec (high energy) at similar tissue contact (8-14 grams). Tetrazolium chloride was injected 15 minutes prior to euthanasia and all tissue were fixed in formalin for ≥7 days. Ablation lesions were scanned in high-resolution and measured using electronic calipers. Results: A total of 114 RF Ablation lesions were measured (57 for each method). In the low energy setting, lesion width was greater in the thigh model (8.37±1.5mm vs. 7.14±1.3mm; p=0.005) while lesion depth was greater in the beating heart (4.72±0.8mm vs. 4.2±0.6mm; p=0.016). The overall lesion volume was similar between the methods (thigh 27.8±7.1mm 2 vs. heart 26.9±7.9mm 2 ; p=0.74). In the high energy setting, lesion depth, width, and overall volume were greater in the thigh lesions (thigh 53.9±10.8mm 2 vs. heart 34.5±9.6mm 2 ; p=0.001). The thigh model demonstrated consistent and predictable lesions compared to the beating heart (r=0.75 vs r=0.53, respectively). There was no difference in steam pop incidence. Conclusion: The thigh model is a reasonable technique for evaluation of Ablation Catheter technology. The correlation of lesion dimensions between thigh model and beating heart is reasonable in low energy settings, however results in overestimation at higher energy setting. Caution should be taken before extrapolation of Ablation data obtained using the thigh model technique to the beating heart physiology.