Summary

• 121 patients underwent PVI with FARAPULSE. The mean procedure time was significantly  reduced from the initial cases from 85 ± 34 min to 72 ± 18 min.
• There was one phrenic nerve palsy with partial remission at follow-up. The KM event-free estimate at 365 days was 80% (88% paroxysmal, 69% persistent).
• In 5/8 re-do procedures, the gaps were primarily located in the right pulmonary veins.
  

Summary

• Registry to study the real-world adoption, workflow, acute and long-term outcomes after pulsed field ablation (PFA) in an all-comer atrial fibrillation (AF) patient population in high-volume European centers, inclusive of learning curve.
• This registry demonstrated consistent, short procedure times with a median of 58 minutes despite a large number of operators with varied experience and workflow.
• There was a low rate of safety events (3.6%) and promising one-year efficacy rate (74%) in a large spectrum of AF patients.
• Operator experience and previous primary ablation modality did not have an effect on the one-year AF/AT recurrence rates showing a rapid adoption of the technology by new operators and prior RF and cryo users.
• A small subset of 149 patients (12%) returned for repeat ablation during follow-up. In these patients, EAM revealed a high rate of PVI with 72% of pulmonary veins being durably isolated.
  

Summary

• Of 1568 patients with AF who underwent PFA, female patients, as compared with male patients, were older, had more paroxysmal AF and fewer comorbidities such as coronary disease, heart failure, and sleep apnea.
• The 1-year Kaplan-Meier estimate for freedom from atrial arrhythmia was similar in male (79.9%) and female (76.3%) patients with no significant difference in acute major adverse events between groups.
  

Summary

• 36 AF patients were treated with PFA and 36 patients with RFA.
• There were no significant differences in patient baseline demographics or AAD usage.
• The ablation time in the PFA group was markedly shorter than RFA.
• At 6 months, there was no statistically significant difference in efficacy.
• In this study, PFA was safe, efficient, and had a short learning curve.
  

Summary

• 100 subjects (80% paroxysmal AF) underwent AF ablation with FARAWAVE. 
• The learning curves of 2 operators (junior/senior) who performed > 20 procedures showed no difference in procedure time, senior (46.9 ± 9.7 min) and junior (45.9 ± 9.9 min).
• The 2 complications that occurred were bleeding at the access site. 

Summary

• Single-center study looking at the adoption and the process of streamlining the procedure in the first 191 patients treated with FARAPULSE PFA. Electrogram validation was performed with a circular mapping catheter (CMC) in the first 25 patients, cerebral MRI was performed in 53 patients and esophageal endoscopy was performed in 52 patients.
• Electrogram information was 100% congruent between the CMC and FARAWAVE. PVI rate was 100%. No esophageal temperate rise or esophageal thermal injuries were observed. Two minor strokes occurred in the first 25 patients, likely due to air embolism during catheter exchanges.
• After the first 25 patients, the procedure times were significantly reduced from an average of 46 ± 14 min to 38 ± 13 min. During short term follow-up, 9% (17/191) of patients had atrial arrhythmia recurrence.

Summary

• Patients were propensity matched, 161 CLOSE protocol guided RFA patients from the PowerPlus study and 161 PFA guided PAF or PersAF patients with FARAPULSE.
• Procedure time was significantly shorter in the FARAPULSE group (47 min vs 71 min for RFA)  with the fluoroscopy time being significantly longer in the FARAPULSE group (15 min PFA vs 11 min RFA).
• One serious adverse event occurred (TIA) in a patient with thrombocytosis in the FAFAPULSE group.
• During a 6-month follow-up period, 24 (15%) FARAPULSE and 27 (17%) RFA patients experienced recurrence with 20 (12%) FARAPULSE repeat procedures and 11 (7%) RFA.
• HDM revealed that 7/20 (35%) patients in the FARAPULSE and 2/11 (18%) patients in the RFA group had all 4 PVs durably isolated.
  

Summary

• CBA and RFA AF patients were propensity matched to PFA, (PFA, n=40), (CBA, n=80) and (RFA, n=80).
• Median procedure times were the shortest with CBA (75 min), followed by PFA (94 min) and RFA (182 min), with RFA having the lowest fluoroscopy dose.
• After 1-year of follow-up, freedom from any atrial arrhythmia was 85% for PFA, 66.2% for CBA, and 73.8% for RFA.
• With propensity matched patients, the results were favorable for the initial use of PFA versus  CBA and RFA.
  

Summary

• 179 patients with paroxysmal AF received de novo PVI with standard power RFA (30–40 W/20–30 s, n = 52), power-controlled HPSD (70 W/5–7 s, n = 60), temperature-controlled HPSD (90 W/4 s,  n = 32), and FARAPULSE PFA (n = 35).
• High-sensitivity cardiac troponin T (hs‐-cTnT), creatine kinase (CK), CK MB isoform (CK-MB),  and white blood cell (WBC) count were determined before and after ablation.
• Post-ablation hs‐-cTnT release was significantly higher with PFA, HPSD-70W, and HPSD-90W  than with standard RFA.
• CK and CK-MB release was increased with PFA by 3.4-fold and 5.8-fold, respectively, as compared to standard RFA.
• PFA was associated with the lowest elevation in WBC compared to standard RFA, HPSD-70W,  and HPSD-90W.
• PFA was associated with the highest myocardial injury and the lowest inflammatory reaction compared to the other energies tested.
  

Summary

• Compared FARAPULSE to high-power short-duration (HPSD) RF looking at efficiency, safety, myocardial injury and midterm outcomes.
• 115 patients (56% paroxysmal) underwent ablation, 52 patients had FARAPULSE ablation and 63 had HPSD RF ablation.
• PFA procedures were significantly shorter (PFA, 58 [53-71] minutes vs HPSD, 83 [71-99] minutes with significantly longer fluoroscopy times (PFA 13 [10-16] minutes vs HPSD 2.2 [1.3-3.6].
• The postoperative troponin levels were significantly higher in the PFA group (1540 ng/l [1010-1980]) vs HPSD (897 ng/l [725-1240]).
• The AF recurrence free rate at 6 months was 85% for the PFA group and 65% for the HPSD group. •  PFA procedures were shorter, there were higher cardiac troponin levels, and the AF-free survival during mid-term follow-up was similar.
  

Summary

• Procedural data from 12 electrophysiologists experienced with balloon technologies was analyzed for a total of 480 procedures (240 balloons, 120 FARAPULSE and 120 HELIOSTAR).
• During the follow-up period of 6.86 ± 3.82 months, there were 11 atrial tachyarrhythmia recurrences (9.17%) in the HELIOSTAR group and 8 (6.67%) in the FARAPULSE group after the 3-month blanking period.
• The number of cases needed to become confident with the new technology, we found a mean number of 10 and 17 procedures for FARAPULSE and HELIOSTAR.
  

Summary

• 348 RF patients.
• There were significant differences in first-pass isolation; 98.8% of pulmonary veins (PVs) with PFA, 81.5% with CBA, and 73.1% with RFA.
• Procedure and dwell times were significantly shorter with PFA, and 3D mapping system usage led to a significant reduction in fluoroscopy exposure with RFA.
• Overall complication rates were 3.4% (n = 6) with PFA, 8.6% (n = 30) with CBA, and 5.5% (n = 19) with RFA.
• The one-year Kaplan–Meier estimated freedom from any atrial tachyarrhythmia was 79.3% with PFA, 74.7% with CBA, and 72.4% with RFA. Freedom from AF was 85.5% with PFA, 78.5% with CBA, and 77.4% with RF.
• Among 145 repeat ablation procedures, PV reconnection rate was significantly different:  19.1% after PFA, 27.5% after CBA, and 34.8% after RFA.
• The most common site of PFA reconnection was the left superior PV (27.3%) consistently involving the anterior aspect and the carina of the vein.
  

Summary

• The ADVENT Pivotal Trial was the first randomized clinical trial that directly compared FARAPULSE™ PFA to standard-of-care thermal ablation devices (force-sensing radiofrequency (RFA) or cryoballoon ablation (CBA), for the treatment of paroxysmal atrial fibrillation (PAF).
• It included an experienced group of thermal ablators with limited clinical experience with the novel FARAPULSE technology.
• In this RCT, FARAPULSE demonstrated: 
• Non-inferiority for both the primary safety and effectiveness outcomes compared to thermal ablation technology (posterior probability > .999).
• Significantly less pulmonary vein cross-sectional narrowing compared to thermal ablation (posterior probability > .999).
• Significantly shorter procedure times, reduced LA dwell time and total ablation time versus thermal ablation. Lower standard deviations across these characteristics also indicate less variability within the PFA procedures.

Summary

• Metanalysis of 19 studies investigating 1050 patients (mean age 60 years, 31% women, time to remap 2–7 months) were included.
• In a pooled analysis, 99.7% of the PVs and 99.4% of patients were successfully ablated at baseline and 75.5% of the PVs remained isolated and 51% of the patients had all PVs persistently isolated at follow-up across all energy sources.
• In a pooled analysis of the percentages of PVs durably isolated during follow-up, the estimates of RFA were the lowest at 71%, but comparable with CBA (79%).
• Higher durability percentages were reported in PVs ablated with laser-balloon (84%)  and PFA (87%).
  

Summary

• Study that compared the procedural outcome data for PVI between FARAWAVE and very  high-power short duration (vHPSD) defined as 70W/7 sec lesions or 70W/5 sec for posterior wall.
• There were 57 patients in each group.
• The FARAWAVE group had significantly shorter procedure duration (65 ± 17 min) versus the vHPSD (95 ± 23 min) with longer fluoroscopy times (15 ± 5 min) vs 12 ± 3 min for vHPSD.
• The freedom from arrhythmia recurrence at a median of 125 days was 80.7% in the FARAWAVE arm versus 77.2% in the vHPSD group.
• Safety event rates were low with 2 tamponades occurring in the FARAWAVE group and 2 groin bleeds in the vHPSD group. One clinically non-significant PV stenosis occurred in the vHPSD group.
  

Summary

• In a clinical trial (NCT03714178), PAF patients under-went PVI with FARAWAVE using a biphasic waveform, and after 75 days, detailed voltage maps were created.
• Comparative voltage mapping data were retrospectively collected from consecutive PAF patients who (i) underwent PVI using thermal energy, (ii) underwent re-ablation for recurrence, and (iii) had durably isolated PVs. The left and right PV antral isolation areas and non-ablated posterior wall were quantified.
• There was no significant difference between the PFA and thermal ablation cohorts in either the left- and right-sided PV isolation areas, or the non-ablated posterior wall area.

Summary

• Data were analyzed from 4 PAF ablation trials using either PFA or RFA.
• Baseline and 3-month cardiac computed tomography scans were reconstructed into 3-dimensional images, and the long and short axes of the PV ostia were quantitatively and qualitatively assessed in a randomized blinded manner.
• PV ostial diameters decreased significantly less with PFA than with RFA (% change; long axis: 0.9% ± 8.5% vs −11.9% ± 16.3%; P < .001 and short axis: 3.4% ± 12.7% vs −12.9% ± 18.5%; P < .001).
• PV narrowing/stenosis was present in 0% and 0% vs 12.0% and 32.5% of PVs and patients who underwent PFA and RFA, respectively.
• In this study, unlike after RFA, the incidence and severity of PV narrowing/stenosis after PV isolation was virtually eliminated with PFA.

Summary

• CBA and RFA AF patients were propensity matched to PFA, (PFA, n=40), (CBA, n=80) and (RFA, n=80).
• Median procedure times were the shortest with CBA (75 min), followed by PFA (94 min) and RFA (182 min), with RFA having the lowest fluoroscopy dose.
• After 1-year of follow-up, freedom from any atrial arrhythmia was 85% for PFA, 66.2% for CBA, and 73.8% for RFA.
• With propensity matched patients, the results were favorable for the initial use of PFA versus  CBA and RFA.
  

Summary

• 141 consecutive AF patients were treated with PFA (n=94) or CBA (n=47).
• At 1 year, 70% of the PFA patients and 61% of the CBA patients were free from AF/AT.
• After PFA, there was a significant improvement in left atrial volume index.
• PFA and CBA had similar efficacy outcomes, but PFA might induce left atrial reverse  remodeling and contribute to left ventricular systolic function.
  

Summary

• Retrospective cohort study conducted at a high-volume center comparing CBA and PFA  in the realworld setting.
• 1714 procedures were analyzed: 1241 in the CBA group and 473 in the PFA group.
• The CBA group had a significantly higher incidence of phrenic nerve palsy compared  with the PFA group (15 vs 0).
• The procedure duration was significantly shorter in the PFA group (95.0 vs 74.0 min).
  

Summary

• 100 PVI patients (PFA (n = 50), CBA (n = 50) underwent PVI ablation.
• Requirement of propofol, midazolam, and sufentanyl was significantly higher in the PFA group compared to CBA.
• Sedation-associated complications did not differ between both groups.
• Non-sedation-associated complications procedure times did not differ between groups.
  

Summary

• 181 AF patients underwent PVI (PFA = 106) and (CBA = 75).
• The median procedure, left atrial dwell, and fluoroscopic times were similar between the PFA  and the CB group; 55 min vs. 58 min, 38 min vs. 37 min, and 11 min vs. 11 min, respectively.
• Three procedural complications were observed in the PFA group (two tamponades, one temporary ST elevation) and 3 complications in the CB group (3 reversible phrenic nerve palsies).
• During the median follow-up of 404 days, AF recurrence was similar in the PFA (24%) group and the CB (30%) group.
  

Summary

• 348 RF patients.
• There were significant differences in first-pass isolation; 98.8% of pulmonary veins (PVs) with PFA, 81.5% with CBA, and 73.1% with RFA.
• Procedure and dwell times were significantly shorter with PFA, and 3D mapping system usage led to a significant reduction in fluoroscopy exposure with RFA.
• Overall complication rates were 3.4% (n = 6) with PFA, 8.6% (n = 30) with CBA, and 5.5% (n = 19) with RFA.
• The one-year Kaplan–Meier estimated freedom from any atrial tachyarrhythmia was 79.3% with PFA, 74.7% with CBA, and 72.4% with RFA. Freedom from AF was 85.5% with PFA, 78.5% with CBA, and 77.4% with RF.
• Among 145 repeat ablation procedures, PV reconnection rate was significantly different:  19.1% after PFA, 27.5% after CBA, and 34.8% after RFA.
• The most common site of PFA reconnection was the left superior PV (27.3%) consistently involving the anterior aspect and the carina of the vein.
  

Summary

• The ADVENT Pivotal Trial was the first randomized clinical trial that directly compared FARAPULSE™ PFA to standard-of-care thermal ablation devices (force-sensing radiofrequency (RFA) or cryoballoon ablation (CBA), for the treatment of paroxysmal atrial fibrillation (PAF).
• It included an experienced group of thermal ablators with limited clinical experience with the novel FARAPULSE technology.
• In this RCT, FARAPULSE demonstrated: 
• Non-inferiority for both the primary safety and effectiveness outcomes compared to thermal ablation technology (posterior probability > .999).
• Significantly less pulmonary vein cross-sectional narrowing compared to thermal ablation (posterior probability > .999).
• Significantly shorter procedure times, reduced LA dwell time and total ablation time versus thermal ablation. Lower standard deviations across these characteristics also indicate less variability within the PFA procedures.

Summary

• Metanalysis of 19 studies investigating 1050 patients (mean age 60 years, 31% women, time to remap 2–7 months) were included.
• In a pooled analysis, 99.7% of the PVs and 99.4% of patients were successfully ablated at baseline and 75.5% of the PVs remained isolated and 51% of the patients had all PVs persistently isolated at follow-up across all energy sources.
• In a pooled analysis of the percentages of PVs durably isolated during follow-up, the estimates of RFA were the lowest at 71%, but comparable with CBA (79%).
• Higher durability percentages were reported in PVs ablated with laser-balloon (84%)  and PFA (87%).
  

Summary

• Retrospective analysis of de novo paroxysmal or persistent AF PVI with FARAWAVE (PFA) (n=54) and the POLARx Cryoballoon (CBA) (n=54).
• The total procedure times excluding the LA mapping were significantly shorter for the PFA group (58.0 ± 12.5 min) vs CBA (73.0 ± 24.8 min). Fluoroscopy time was significantly longer in the PFA arm. Subgroup analysis showed a significant reduction in procedure time with continued use of FARAPULSE.
• At 273 ± 129 days, the arrhythmia recurrence free rate was similar for both devices, 74% for PFA and 72% for CBA.
• HR changes between baseline and 3 month follow up did not differ between both groups  (PFA: 4 ± 8 beats/min, CBA: 4 ± 11 beats/min).
  

Summary

• 400 patients were treated with FARAPULSE (n=200) or cryoballoon ablation (CBA) (n=200). 
• The mean procedure times were significantly shorter in the FARAPULSE group (34.5 [29-40] mins) vs CBA (50 [45-60] mins) with similar fluoroscopy times.
• The overall procedural complication rates were 6.5% in the CBA and 3.0% in the FARAPULSE group driven by a higher rate of phrenic nerve palsy in the CBA group.
• The 1-year freedom from arrhythmia recurrence rates in paroxysmal AF were similar with 83.1% in the CBA group and 80.3% in the FARAPULSE group.
  

Summary

• Single-center study looking at procedural characteristics and the size of acute PVI antral lesions with high-density mapping in 43 patients treated with PFA compared to 20 patients treated with cryoballoon ablation.
• All patients had 100% acute vein isolation with no early reconnections. The acute antral lesion size of PFA lesions (67.03 ± 12.69%) were significantly larger compared to cryoballoon (57.39 ± 10.91%).
• In the PFA group there was no acute phrenic nerve injury, and 1 (4.34%) patient stroke.

Summary

• Troponin T is a measure of myocardial cell death. Troponin T was measured in 60 patients one day before and the morning after PVI ablation with FARAWAVE, radiofrequency or cryoballoon ablation. No additional lesion sets were performed.
• Post-procedure Troponin T levels with PFA were 1.6x and 1.9x higher vs RF and Cryo, respectively with no significant difference between the RF and cryo groups.

Summary

• In a clinical trial (NCT03714178), PAF patients under-went PVI with FARAWAVE using a biphasic waveform, and after 75 days, detailed voltage maps were created.
• Comparative voltage mapping data were retrospectively collected from consecutive PAF patients who (i) underwent PVI using thermal energy, (ii) underwent re-ablation for recurrence, and (iii) had durably isolated PVs. The left and right PV antral isolation areas and non-ablated posterior wall were quantified.
• There was no significant difference between the PFA and thermal ablation cohorts in either the left- and right-sided PV isolation areas, or the non-ablated posterior wall area.

Summary

• Patients were propensity matched, 161 CLOSE protocol guided RFA patients from the PowerPlus study and 161 PFA guided PAF or PersAF patients with FARAPULSE.
• Procedure time was significantly shorter in the FARAPULSE group (47 min vs 71 min for RFA)  with the fluoroscopy time being significantly longer in the FARAPULSE group (15 min PFA vs 11 min RFA).
• One serious adverse event occurred (TIA) in a patient with thrombocytosis in the FAFAPULSE group.
• During a 6-month follow-up period, 24 (15%) FARAPULSE and 27 (17%) RFA patients experienced recurrence with 20 (12%) FARAPULSE repeat procedures and 11 (7%) RFA.
• HDM revealed that 7/20 (35%) patients in the FARAPULSE and 2/11 (18%) patients in the RFA group had all 4 PVs durably isolated.
  

Summary

• 348 RF patients.
• There were significant differences in first-pass isolation; 98.8% of pulmonary veins (PVs) with PFA, 81.5% with CBA, and 73.1% with RFA.
• Procedure and dwell times were significantly shorter with PFA, and 3D mapping system usage led to a significant reduction in fluoroscopy exposure with RFA.
• Overall complication rates were 3.4% (n = 6) with PFA, 8.6% (n = 30) with CBA, and 5.5% (n = 19) with RFA.
• The one-year Kaplan–Meier estimated freedom from any atrial tachyarrhythmia was 79.3% with PFA, 74.7% with CBA, and 72.4% with RFA. Freedom from AF was 85.5% with PFA, 78.5% with CBA, and 77.4% with RF.
• Among 145 repeat ablation procedures, PV reconnection rate was significantly different:  19.1% after PFA, 27.5% after CBA, and 34.8% after RFA.
• The most common site of PFA reconnection was the left superior PV (27.3%) consistently involving the anterior aspect and the carina of the vein.
  

Summary

• 1,184 patients (62% PAF) had a PVI procedure using FARAPULSE. 272 (23%) patients had an arrhythmia recurrence.
• Of these, 144 (53%) underwent a left atrial redo procedure a median of 7 months post-ablation.
• 3D electro-anatomical maps identified 404 of 567 pulmonary veins (71%) with durable isolation.
• Physicians with experience with CBA had a significantly higher PVI durability rate compared to operators with only RFA experience (76% vs 60%).
• The operators’ experience in AF ablation (≤5 vs >5 years) or the size of the PFA device used  (31 mm vs 35 mm) did not have an impact on lesion durability in redo patients.
  

Summary

• Redo ablation was performed on 29/341 (8.5%) of patients for arrhythmia recurrence.
• At 6-months post index ablation, mapping identified 69/110 (63%) durable PV isolation. In 6 (21%) all PVs were durability isolated.
• PV reconnections were often found on the right sided veins and on the anterior aspects  of the upper veins.
• Importantly, only minor regression was observed between the index and redo procedures (median of 3 mm).
  

Summary

• The pulmonary vein durability rate was 69% in repeat ablation patients (n=26) that had a FARAPULSE procedure an average of 292 ± 119 days after the de novo ablation.
• Patients who underwent posterior wall isolation had a durable PW isolation rate of 80% (4/5).
• Reconnection was observed in the LSPV (27%), LIPV (19%), RSPV (35%), RIPV (42%) with the gaps significantly clustered in the right sided anterior carina compared to other regions.
  

Summary

• Patients who had a de novo procedure with FARAWAVE that had recurrence and subsequent repeat ablation (14/447) procedures were analyzed. The mean time to recurrence was  4.9 ± 1.9 months.
• PV reconnection was found in zero (35.7%), one (21.4%), two (14.3%) or three (28.6%) of patients. 
• Durable PVI was observed in over 1/3 of redo patients. The most common arrhythmia recurrence following PVI only was AF. Concomitant (35.7%) or isolated AFL/AT (14.3%) recurrence was observed in 50% of patients.
  

Summary

• In redo patients initially treated with FARAPULSE using the 5S strategy, the incidence of pulmonary vein (PV) reconnection was assessed (inclusive of learning curve). 
• Among the 360 patients, 25 patients (19 paroxysmal) underwent a redo procedure in 6.1 ± 4 months.
• The PV durable isolation rate was 90.9% as assessed by high-density mapping.
• The mechanism of all but one atrial tachyarrhythmia was macro-reentry. 
• The mean % of isolated posterior wall surface area was 72.7 ± 19.0%. 
• There was a low rate of PV reconnection (9.1%) in redo patients and the unique features of the FARAWAVE catheter design and optimized workflow enabled wide antral lesion creation without regression over time. 

Summary

• Patients with PAF underwent PVI with FARAWAVE. A comparison of voltage maps immediately after PFA and at a median of 84 days (interquartile range 69–90 days) later revealed that there was no significant difference in either the left and right-sided PV antral isolation areas or nonablated posterior wall area.
• The distances between low-voltage edges on the posterior wall were also not significantly different between the 2 time points.
• The level of PV antral isolation after PFA with FARAWAVE persisted without regression.

Summary

• In 3 multicenter studies (IMPULSE, PEFCAT and PEFCAT II), PAF patients underwent PVI using a basket and flower PFA catheter.
• Invasive remapping was performed at 2 to 3 months, and reconnected PVs were reisolated with PFA or radiofrequency ablation. After a 90-day blanking period, arrhythmia recurrence was assessed over 1-year follow-up.
• In 121 patients, acute PVI was achieved in 100% of PVs with PFA alone. 
• PV remapping, performed in 110 patients at 93.0 ± 30.1 days, demonstrated durable PVI in 84.8% of PVs (64.5% of patients), and 96.0% of PVs (84.1% of patients) treated with the optimized biphasic energy PFA waveform.
• The 1-year Kaplan-Meier estimates for freedom from any atrial arrhythmia for the entire cohort and for the optimized biphasic energy PFA waveform cohort were 78.5 ± 3.8% and 84.5 ± 5.4%, respectively.

Summary

• PersAFOne was a single-arm study evaluating biphasic, bipolar PFA with FARAWAVE for PVI and LAPW ablation to assess the safety and lesion durability of pulsed field ablation (PFA) for both PVI and LAPW ablation in persistent AF.
• In 25 patients, acute PVI (96 of 96 pulmonary veins) were 100% acutely successful with the FARAWAVE catheter. Using the focal PFA catheter, acute cavotricuspid isthmus block was achieved in 13 of 13 patients.
• Post-procedure EGD and repeat cardiac computed tomography revealed no mucosal lesions or PV narrowing, respectively.
• Invasive remapping at 2 to 3 months demonstrated durable isolation (defined by entrance block) in 82 of 85 PVs (96%) and 21 of 21 LAPWs (100%) treated with the pentaspline catheter.

Summary

• 100 patients underwent PFA-PVI with PWI with FARAWAVE.
• Median procedure time was 66 min, and fluoroscopy time was 11 (8–14) min.
• PWI using PFA was achieved in 100% of patients with a median of 19 applications with no reported major complications.
• Recurrent AF/AT was noted in 15 patients (15%) during a median follow-up of 144 days.
  

Summary

• Single-center study where patients had coronary angiography performed in patients who previously had vasospasm during FARAPULSE ablation to determine long-term effects of PFA  on coronary arteries.
• Coronary vasospasm occurred during FARAPULSE ablation in 30 patients.
• The spasm was localized as follows: Adjacent to the RCA in 21 pts during CTI ablation with either FARAWAVE (38%) or FARAPOINT (62%) catheters. Adjacent to the left circumflex artery in 8 pts.
• Intracoronary nitroglycerin helped resolve the vasospasm in 18 patients, whereas it spontaneously resolved in the remaining 12 patients with one patient (3.3%) having transient  ST-segment depression.
• Coronary angiography was performed after a median of 11 months post-ablation.
• No patients (0 of 30) had new coronary irregularities or stenosis at the site of previous vasospasm, whether the initial PFA procedure had been performed with FARAWAVE  or FARAPOINT.
• This was an initial description of favorable long-term safety of FARAPULSE PFA when performed in close proximity to coronary vessels.
  

Summary

• The pulmonary vein durability rate was 69% in repeat ablation patients (n=26) that had a FARAPULSE procedure an average of 292 ± 119 days after the de novo ablation.
• Patients who underwent posterior wall isolation had a durable PW isolation rate of 80% (4/5).
• Reconnection was observed in the LSPV (27%), LIPV (19%), RSPV (35%), RIPV (42%) with the gaps significantly clustered in the right sided anterior carina compared to other regions.
  

Summary

• 131/547 PersAF (24%) patients in MANIFEST-PF received adjunctive left atrial posterior wall (LAPW) ablation.
• Compared to PVI-alone, patients receiving adjunctive LAPW ablation were younger, had a lower CHA2DS2-VASc score, and were more likely to receive mapping and ICE imaging.
• The 1-year Kaplan-Meier estimate for freedom from atrial arrhythmias was similar between groups (PVI+LAPW: 66.4% vs PVI: 73.1%).
• After propensity matching, the 1-year effectiveness remained similar between groups (PVI+LAPW: 71.7% vs. PVI: 68.5%).
• There was no significant difference in major adverse events between the groups (2.2% vs. 1.4%).
  

Summary

• 26 patients underwent PVI with either PFA (n = 17) or RFA (n = 9) along the mitral isthmus ablation.
• Coronary spasm was observed in 7 of 17 patients (41.2%) undergoing PFA: in 7 of 9 (77.8%)  when the mitral isthmus ablation line was situated superiorly and in 0 of 8 when placed inferior.
• Coronary spasm did not occur in any of the 9 patients undergoing RFA.
• 5 patients received crossover PFA after RFA failed to achieve conduction block, coronary  spasm occurred in 3 (60%).
• Most instances of spasm (9/10, 90%) were subclinical, with 2 (20%) requiring nitroglycerin administration. The median time to resolution of spasm was 5 minutes.
  

Summary

• PVI, posterior wall (PW) and mitrial isthmus (MI) ablation were performed in 45 patients with persistent AF.
• The acute success of PVI, PW isolation, and MI block was 100%.
• There were 2 (4.4%) coronary artery spasms which were reversible after intravenous nitrate infusion.
• During a mean follow-up of 107 ± 59.5 days, there was a 20% rate of arrhythmia recurrence.
  

Summary

• Persistent AF patients were treated with PVI + (n=16) or PVI ++ posterior wall isolation (n=59)  with FARAWAVE with 32 patients being de novo and 43 patients were repeat ablation patients.
• In the redo cohort, 67% of all PVs were isolated.
• PVI + PWI had an average procedure time of 91 ± 30 min and two minor complications occurred.
• The 354 ± 197-day freedom from atrial arrhythmias (allowing AADs) in the PVI + PWI cohort  was 79.3%.
• PWI guided by FARAPULSE had favorable outcomes with a low number of complications.
  

Summary

• Posterior wall ablation was performed in 215 patients (67% redo procedures) and was successful in all patients by applying a median of 36 PFA lesions.
• The rate of severe adverse events was 0.9%, one cardiac tamponade, and one vascular  access complication.
• Median follow-up was 7.3 months. The one-year arrhythmia-free Kaplan–Meier analysis was 53%.
• A redo procedure was performed in 26 patients (12%) after a median of 6.9 months and showed durable PWA in 22 patients (85%) with minor lesion regression.
• There was posterior wall reconnection in four patients with three (75%) having roof-dependent AT.
  

Summary

• Lesion formation was assessed with late gadolinium enhancement CMR (LGE-CMR) 3-months after FARAPULSE ablation.
• In 10 patients, PVI and posterior wall isolation (PWI) was performed with FARAWAVE.  The mean procedure duration was 62 ± 7 min with a mean LA dwell time of 13 ± 2 min.
• The mean LA scar burden was 8.1 ± 2.1% with a mean scar width of 12.8 ± 2.1 mm.  At 7 months, 9/10 (90%) of patients were recurrence free.
• LGE CMR analysis found homogenous and continuous lesion patterns with no evidence of PV stenosis or collateral damage to adjacent structures.
  

Summary

• 72 patients were treated with FARAPULSE. Blood samples were evaluated for 14 cardiac biomarkers for stress, myocardial fibrosis, inflammation and coagulation activity 3, 24, and 48 hours after ablation.
• CK-MB, hs-cTnI, myoglobin, and WBC levels displayed an increase at 3-h post-ablation, followed by a decline towards lower values within 24 h. C-reactive protein peaked at 48 hours, exhibiting a gradual increase over time.
• Markers of hemolysis and potential end organ damage exhibited fluctuations within the normal range for this population.
• Following the procedure, markers indicating coagulation activity, such as hemoglobin, hematocrit, and platelet count, exhibited a decline which was similar to other ablation energies.
• There appeared to be no correlation between cardiac enzyme elevations and extension of PFA beyond the PVs.
  

Summary

• 65 AF patients were treated (PFA = 33) and (RFA= 32) with both groups being similar in baseline characteristics.
• Procedure and LA dwell times were substantially shorter in the PFA group (55 min vs 151 min and 36 min vs 116 min).
• Peak troponin release was substantially higher in the PFA group and both PFA and RFA were associated with similar extents (>50%) of platelet and coagulation activation.
• Despite 10 times more myocardial damage, pulsed-field ablation was associated with a similar degree of platelet/coagulation activation, and slightly lower inflammatory response.
  

Summary

• 179 patients with paroxysmal AF received de novo PVI with standard power RFA (30–40 W/20–30 s, n = 52), power-controlled HPSD (70 W/5–7 s, n = 60), temperature-controlled HPSD (90 W/4 s,  n = 32), and FARAPULSE PFA (n = 35).
• High-sensitivity cardiac troponin T (hs‐-cTnT), creatine kinase (CK), CK MB isoform (CK-MB),  and white blood cell (WBC) count were determined before and after ablation.
• Post-ablation hs‐-cTnT release was significantly higher with PFA, HPSD-70W, and HPSD-90W  than with standard RFA.
• CK and CK-MB release was increased with PFA by 3.4-fold and 5.8-fold, respectively, as compared to standard RFA.
• PFA was associated with the lowest elevation in WBC compared to standard RFA, HPSD-70W,  and HPSD-90W.
• PFA was associated with the highest myocardial injury and the lowest inflammatory reaction compared to the other energies tested.
  

Summary

• Compared FARAPULSE to high-power short-duration (HPSD) RF looking at efficiency, safety, myocardial injury and midterm outcomes.
• 115 patients (56% paroxysmal) underwent ablation, 52 patients had FARAPULSE ablation and 63 had HPSD RF ablation.
• PFA procedures were significantly shorter (PFA, 58 [53-71] minutes vs HPSD, 83 [71-99] minutes with significantly longer fluoroscopy times (PFA 13 [10-16] minutes vs HPSD 2.2 [1.3-3.6].
• The postoperative troponin levels were significantly higher in the PFA group (1540 ng/l [1010-1980]) vs HPSD (897 ng/l [725-1240]).
• The AF recurrence free rate at 6 months was 85% for the PFA group and 65% for the HPSD group. •  PFA procedures were shorter, there were higher cardiac troponin levels, and the AF-free survival during mid-term follow-up was similar.
  

Summary

• Fibroblast activation was used as a surrogate for ablation damage after FARAPULSE (n=15)  and CBA (n=11) ablation.
• Fibroblast activation tissue response was less pronounced in the PFA patient cohort vs CBA.
  

Summary

• Compared lesion formation and lesion extent (measured with mapping and biomarkers) between FARAPULSE and HELIOSTAR (multi-electrode RF balloon).
• 60 paroxysmal patients (28 PFA, 32, RF balloon) underwent PVI, high density mapping and Troponin I was quantified.
• The posterior wall ablation area was significantly larger in the PFA group.
• In a subset of 38 patients, the serum Troponin was significantly higher in the PFA group,  likely due to it creating larger lesions.
  

Summary

• Troponin T is a measure of myocardial cell death. Troponin T was measured in 60 patients one day before and the morning after PVI ablation with FARAWAVE, radiofrequency or cryoballoon ablation. No additional lesion sets were performed.
• Post-procedure Troponin T levels with PFA were 1.6x and 1.9x higher vs RF and Cryo, respectively with no significant difference between the RF and cryo groups.

Summary

• Nerve injury biomarkers and DW-MRI were conducted on 18 patients in a pilot study.
• Serum nerve injury biomarkers did not differ between pre- and post-ablation. Heart rate variability did not differ and there were no acute cerebral microemboli events.
• FARAPULSE PVI did not induce nerve injury in this study.
  

Summary

• Assessed the effects of FARAPULSE ablation on the ganglionated plexi and autonomic nervous system (ANS) by looking at the degree of acute vagal modulation induced immediately following FARAPULSE ablation.
• De novo PVI patients treated with FARAPULSE (n=40) or cryoballoon (n=36) were assessed with extracardiac vagal simulation (ECVS) to capture the effects of ablation. To capture any transient effects, the subgroup was assessed before PVI, immediately after PVI and 10 minutes after the last ablation application.
• Baseline values were similar, but the vagal response induced by ECVS almost disappeared in the thermal group but persisted in the FARAPULSE group. Intraprocedural vagal reactions occurred more frequently with FARAPULSE than thermal. The heart rate 24-hour post ablation increased more with thermal than PFA ablation.
• In the subgroup with repeated ANS modulation assessment, PFA had a significant acute suppression of vagal response immediately after ablation which recovered almost completely within a few mins after ablation.
• FARAPULSE was found to be associated with only transitory, short vagal effects on the ANS.
  

Summary

• Heart rate was assessed pre and post PVI using FARAPULSE (n=40), Cryoablation (n=40)  and radiofrequency (n=40) PVI ablation to understand the impact of pulsed field ablation on the ganglionated plexi (GP).
• Between baseline and 3 months, heart rates increased by 8.9 ± 11.4 (RF), 11.1 ± 9.4 (CB),  and -0.1 ± 9.2 (PFA) beats/min.
• Unlike thermal ablation, FARAPULSE PFA had minimal effects on the GPs.
  

Summary

• 20 FARPULSE patients were compared to a previous cohort of 57 patients who underwent thermal ablation (33 CBA, 24 RFA).
• Following PFA, there were no mucosal lesions, food retention, or ablation induced vagal nerve injury; 4 patients showed periesophageal edema.
• After thermal ablation, 33/57 (58%) showed esophageal or periesophageal injury; 4/57 mucosal lesion, 18/57 food retention, 17/57 vagal nerve injury and 20/52 edema.
• In contrast to thermal methods, PFA was not associated with the same amount of esophageal injury.
  

Summary

• Median intraluminal esophageal temperature change was statistically significant and increased by 0.8 ± 0.6°C.
• A TESO increase ≥ 1°C was observed in 10/43 (23%) patients. The highest TESO measured was 0.3°C.
• All patients remained asymptomatic, and no atrio-esophageal fistula was reported on follow-up.
  

Summary

• The MANIFEST-PF registry was a retrospective survey of 24 centers with 90 operators, 1758 patients that assessed the real-world performance (use case, acute effectiveness, safety) of FARAPULSE.
• Procedure time was 65 min, fluoroscopy time was 13.7 min. There was a 99.9% mean acute PVI success rate. 
• There were no esophageal complications reported, no phrenic nerve injury persisting beyond hospital discharge and no reported PV stenosis. There was a 1.6% rate of major complications, a 3.87% rate of minor complications and 0.46% rate of energy-specific adverse events.
• Root cause analysis showed that most of the pericardial tamponades and stroke were attributable to catheter workflow and manipulation, independent of energy modality. Complications were plotted on a timeline, and it indicated an improvement in complication rate over time. 

Summary

• Single-center 30 patient study looking at phrenic nerve injury and high-density mapping pre- and post-ablation.
• Acute PVI rate was 100%, the median procedure time was 116 min and the FARAWAVE catheter dwell time was 29 min. There was no esophageal or phrenic nerve injury.
• 97% of patients were in sinus rhythm after 90 days.

Summary

• Cardiac magnetic resonance (CMR) imaging was performed before, acutely (less than 3 h) and 3 months post-ablation in 41 PAF patients undergoing PVI with PFA (N= 18, FARAPULSE) or thermal methods (N= 23, 16 radiofrequency, 7 cryoballoon).
• Esophageal and aortic injuries were assessed by using late gadolinium-enhanced (LGE) imaging. Phrenic nerve injuries were assessed from diaphragmatic motion on intra-procedural fluoroscopy.
• Acutely, thermal methods induced high rates of esophageal lesions (43%), all observed in patients showing direct contact between the esophagus and the ablation sites.
• Esophageal lesions were observed in no patient ablated with PFA (0%, P < 0.001 vs. thermal methods), despite similar rates of direct contact between the esophagus and the ablation sites (P = 0.41). 
• Acute lesions were detected on CMR on the descending aorta in 10/23 (43%) after thermal ablation, and in 6/18 (33%) after PFA (P = 0.52). CMR at 3 months showed a complete resolution of esophageal and aortic LGE in all patients.

Summary

• Single-center study where patients had coronary angiography performed in patients who previously had vasospasm during FARAPULSE ablation to determine long-term effects of PFA  on coronary arteries.
• Coronary vasospasm occurred during FARAPULSE ablation in 30 patients.
• The spasm was localized as follows: Adjacent to the RCA in 21 pts during CTI ablation with either FARAWAVE (38%) or FARAPOINT (62%) catheters. Adjacent to the left circumflex artery in 8 pts.
• Intracoronary nitroglycerin helped resolve the vasospasm in 18 patients, whereas it spontaneously resolved in the remaining 12 patients with one patient (3.3%) having transient  ST-segment depression.
• Coronary angiography was performed after a median of 11 months post-ablation.
• No patients (0 of 30) had new coronary irregularities or stenosis at the site of previous vasospasm, whether the initial PFA procedure had been performed with FARAWAVE  or FARAPOINT.
• This was an initial description of favorable long-term safety of FARAPULSE PFA when performed in close proximity to coronary vessels.
  

Summary

• 26 patients underwent PVI with either PFA (n = 17) or RFA (n = 9) along the mitral isthmus ablation.
• Coronary spasm was observed in 7 of 17 patients (41.2%) undergoing PFA: in 7 of 9 (77.8%)  when the mitral isthmus ablation line was situated superiorly and in 0 of 8 when placed inferior.
• Coronary spasm did not occur in any of the 9 patients undergoing RFA.
• 5 patients received crossover PFA after RFA failed to achieve conduction block, coronary  spasm occurred in 3 (60%).
• Most instances of spasm (9/10, 90%) were subclinical, with 2 (20%) requiring nitroglycerin administration. The median time to resolution of spasm was 5 minutes.
  

Summary

• Respiratory tract CT scans were performed on 60 patients post FARAPULSE ablation to look  for bronchial damage with either straight-tip (n=30) or J-tip (n=30) guidewires.
• In 12/30 patients with the straight-tip, extra-stiff guidewire, small amounts of old blood without active bleeding were detected with no evidence of thermal lesions. There was no clinical relevance at 30 days post-procedure.
• Use of the straight-tip guidewire may lead to asymptomatic bronchial damage which was not detected when the J-tip guidewire was used.
  

Summary

• 6 swine were infarcted to assess penetration of scar, risk of arrhythmias and lesion imaging evaluation.
• FARAPULSE PFA successfully penetrated scar without significant differences in the lesion depth of infarcted tissue (5.9 ± 1.0 mm) vs healthy (5.7 ± 1.3 mm) myocardium. 
• In ungated QRS PFA applications, sustained ventricular arrhythmias requiring defibrillation occurred in 4/187 (2.1%) applications with zero occurring during gated applications.
• Dark-blood late-gadolinium-enhanced sequences allowed for improved endocardial border detection.

Summary

• 4 swine, FARAWAVE lesions were delivered directly to the left anterior descending artery, left circumflex artery or normal myocardium.
• Angiography was performed to quantify the degree of coronary artery narrowing and histology was performed at 4 and 8 weeks.
• Acute luminal narrowing immediately after PFA was 47% which gradually resolved over 30 minutes.
• Epicardial lesions had a median depth of 4.1 mm and 87.5% of the arteries had minimal to mild stenosis via neointimal hyperplasia.

Summary

• 10 swine were infarcted to evaluate how PFA and RF perform in areas of myocardial scar.
• In myocardial scar, lesion depth was not different between the FAWAVAVE or the FOCAL PFA catheter.
• In myocardial scar, lesion depth was significantly greater for PFA vs RF.
• In a pre-clinical animal model, unlike RF, FARAPULSE PFA was able to effectively ablate surviving islands of myocardium in infarct-related ventricular substrate. 

Summary

• A novel preclinical model was created to nonsurgically assess the response to esophageal injury. This was accomplished by delivering the energy source from within the inferior vena cava, against the esophagus (which was purposefully mechanically deviated towards the IVC).
• Biphasic pulsed field ablation induced no chronic histopathologic esophageal changes, whereas radiofrequency catheter ablation demonstrated a spectrum of esophageal lesions including esophageal ulcers, abscess, and fistula.

Summary

• Assessment of safety and feasibility of FARAPULSE PFA in swine ventricles with a prototype steerable endocardial catheter.
• Gross measurements, available for 28 of 30 ablation sites, revealed average lesion dimensions to be 6.5 ± 1.7 mm deep and 22.6 ± 4.1 mm, with a maximum depth and width of 9.4 mm and 28.6 mm respectively. In PFA lesions, fibrous tissue homogeneously replaced myocytes. When present in the lesion zone, nerve fascicles and vasculature were preserved.

Summary

• In this study, the safety, efficacy, and durability of achieving catheter-based electrical isolation of PVI was demonstrated using optimized monophasic and biphasic PFA waveforms and procedural and histological characteristics of PFA in swine atrial tissue was described.
• Both waveforms created confluent myocardial lesions that demonstrated a myocardial-specific ablative effect.
• Biphasic PFA was more durable than monophasic PFA and radiofrequency ablation lesions.

Summary

• A pilot patient cohort (n=20) underwent PFA ablation for AF (PVI) with different CIEDs. 
• CIEDs included pacemaker, implantable cardioverter-defibrillators (ICD), or cardiac resynchronization therapy plus defibrillator (CRT-D).
• CIED pre- and post-PFA interrogation of the devices showed no significant alterations to the parameters or function of the CIEDs and no lead dislodgement.