News | May 25, 2018

First-in-human Electroporation Ablation Study Finds Pulsed Electric Fields Can Target Specific Tissue For Atrial Fibrillation

Pulsed electric field (PEF) energy ablates non-thermally by creating microscopic pores in cell membranes

First-in-human Electroporation Ablation Study Finds Pulsed Electric Fields Can Target Specific Tissue For Atrial Fibrillation. #HRS2018 #HRS18

Figure 1: Images showing the effect of both surgical epicardial PEF ablation and catheter based PEF ablation in the first-in-human electroporation ablation study to freat Afib.

May 25, 2018 — Data from the first-in-human study using pulsed electric field (PEF) energy ablate heart tissue in the treatment atrial fibrillation shows very positive evidence and may usher in a new era of tissue-specific, ultra-rapid ablation. This was according to researchers presenting this late-breaking study at Heart Rhythm 2018, the Heart Rhythm Society’s 39th Annual Scientific Sessions.

Standard thermal energy sources rely on time-dependent conductive heating/cooling, and ablates all tissue types indiscriminately. PEF energy ablates non-thermally by creating microscopic pores in cell membranes, called electroporation. PEF is highly tissue selective since characteristic threshold field strengths induce necrosis in specific tissues and leave other surrounding tissue unharmed. 

This is attractive to consider for AF ablation since cardiomyocytes have among the lowest threshold values (400 V/cm) of any tissue, which allows tissue selectivity and minimizing ablation of non-target tissue (including the esophagus, phrenic nerve, etc.). PEF also is fast (energy delivered over just a few seconds), and the absence of coagulative necrosis obviates the risk of pulmonary vein (PV) stenosis. 

PEF ablation was performed in two trials using custom systems. The Iowa Approach Inc. system (Figure 1) uses a epicardial linear catheter for PV plus left atrium (LA) encircling to generate a posterior box lesion during concomitant cardiac surgery. The other system used an endocardial over-the-wire catheter for percutaneous transeptal PV isolation. For all cases, endocardial LA-PV voltage maps were created pre- and post-encirclement (using either the Boston Scientific Rhythmia or Biosense Webster Carto electromapping systems).

At two centers, 22 patients were ablated under general anesthesia: A) 7 epicardial patients during valve (6) or CABG (1) surgery - 69±6.4 years, 2F/5M, 6 PAF/1 PerAF, and B) 15 endocardial patients —64±4.6 yrs, 8F/7M, all PAF. Box lesions were successful in 6 out of 7 epicardial patients (86%) using two lesions per patient. The failure was related to equipment malfunction. Including mapping, procedure time for epicardial ablation was 55±21 min. 

Catheter PVI was successful in all 57 PVs in 15 patients (100%) using 3.3±0.5 lesions/PV. Procedure time was 67±10 min, catheter time (PEF catheter entry to exit of LA) = 19±2.5 min (range 16 - 23), total PEF energy delivery time < 60 sec/pt, fluoroscopy time = 12±4.0 min. There were no complications.

The researchers said these data may help usher in a new era of tissue-specific, ultra-rapid ablation of atrial fibrillation. They said PEF appears promising for AF ablation, but additional studies are warranted.

Electroporation is discussed as a new technique in the VIDEO Current State of Atrial Fibrillation Ablation Technologies

Find links to all the Heart Rhythm 2018 late-breaking studies.

Related Content

Medtronic Cryoballoon Improves Quality of Life, Reduces Systems of Persistent Atrial Fibrillation
News | Ablation Systems | August 28, 2018
Medtronic plc announced new findings from the CRYO4PERSISTENT AF clinical trial demonstrating improved quality of life...
Thermedical Announces FDA IDE Approval for Clinical Study of Durablate Catheter
News | Ablation Systems | August 02, 2018
Thermedical announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device...
Boston Scientific to Acquire Cryterion Medical Inc.
News | Ablation Systems | July 13, 2018
Boston Scientific Corp. recently announced a definitive agreement to acquire Cryterion Medical Inc., a privately-held...
Treating AFib With Ablation Reduces Mortality and Stroke
News | Ablation Systems | July 05, 2018
Using catheter-based ablation instead of medications alone reduces the risks of death and stroke in patients with the...
LuxCath Showcases OmniView Light-Guided Ablation Catheter at HRS 2018
News | Ablation Systems | May 22, 2018
LuxCath LLC showcased the next generation of its proprietary OmniView light-guided catheter ablation system at the 2018...
The Kardium Globe combined mapping and ablation catheter. The device has a distal multi-electrode array consisting of 16 ribs with 122 gold-plated electrodes. Ablation can be done with up to 24 electrodes simultaneously.  #HRS2018

The Kardium Globe combined mapping and ablation catheter. The device has a distal multi-electrode array consisting of 16 ribs with 122 gold-plated electrodes. Ablation can be done with up to 24 electrodes simultaneously. 

News | Ablation Systems | May 21, 2018
May 21, 2018 — Complete pulmonary vein isolation (PVI) was achieved in more than 99 percent of patients in a first-in
CardioFocus Announces Successful Live Case Featuring HeartLight X3 System
News | Ablation Systems | May 17, 2018
Medical device manufacturer CardioFocus Inc. announced a successful live case featuring its HeartLight X3 System during...
Imricor MRI-Guided Cardiac Ablation Study Results to Be Presented at HRS 2018
News | Ablation Systems | May 10, 2018
Results from the clinical study to evaluate Imricor’s Vision-MR Ablation Catheter for the treatment of atrial flutter...
Biosense Webster Launches Carto Vizigo Bi-Directional Guidance Sheath
Technology | Ablation Systems | May 08, 2018
Biosense Webster Inc. announced its Carto Vizigo Bi-directional Guiding Sheath is now available in the United States....
Stereotaxis and Acutus Medical Announce Strategic Collaboration
News | Ablation Systems | May 04, 2018
Stereotaxis and Acutus Medical announced a strategic collaboration to integrate the Stereotaxis Niobe Magnetic...
Overlay Init