scholarly journals First-in-Human Experience and Acute Procedural Outcomes Using a Novel Pulsed Field Ablation System: The PULSED AF Pilot Trial

Author(s):  
Atul Verma ◽  
Lucas Boersma ◽  
David E. Haines ◽  
Andrea Natale ◽  
Francis E. Marchlinski ◽  
...  

Background: Pulsed field ablation (PFA) is a novel form of ablation using electrical fields to ablate cardiac tissue. There are only limited data assessing the feasibility and safety of this type of ablation in humans. Methods: PULSED AF (Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF; https://www.clinicaltrials.gov ; unique identifier: NCT04198701) is a nonrandomized, prospective, multicenter, global, premarket clinical study. The first-in-human pilot phase evaluated the feasibility and efficacy of pulmonary vein isolation using a novel PFA system delivering bipolar, biphasic electrical fields through a circular multielectrode array catheter (PulseSelect; Medtronic, Inc). Thirty-eight patients with paroxysmal or persistent atrial fibrillation were treated in 6 centers in Australia, Canada, the United States, and the Netherlands. The primary outcomes were ability to achieve acute pulmonary vein isolation intraprocedurally and safety at 30 days. Results: Acute electrical isolation was achieved in 100% of pulmonary veins (n=152) in the 38 patients. Skin-to-skin procedure time was 160±91 minutes, left atrial dwell time was 82±35 minutes, and fluoroscopy time was 28±9 minutes. No serious adverse events related to the PFA system occurred in the 30-day follow-up including phrenic nerve injury, esophageal injury, stroke, or death. Conclusions: In this first-in-human clinical study, 100% pulmonary vein isolation was achieved using only PFA with no PFA system–related serious adverse events.

Heart Rhythm ◽  
2021 ◽  
Vol 18 (8) ◽  
pp. S10
Author(s):  
Kuldeep Bharat Shah ◽  
Nishaki Mehta ◽  
Ilana B. Kutinsky ◽  
Mark T. Stewart ◽  
Atul Verma ◽  
...  

2018 ◽  
Vol 17 (2) ◽  
pp. 227-248 ◽  
Author(s):  
Stephen M. Schmitz ◽  
Hector L. Lopez ◽  
Douglas Mackay ◽  
Haiuyen Nguyen ◽  
Paula E. Miller

2015 ◽  
Vol 18 (4) ◽  
pp. 188
Author(s):  
D. V. Losik ◽  
V. V. Shabanov ◽  
R. T. Kamiev ◽  
S. N. Artemenko

This clinical case report shows a rare complication following pulmonary vein isolation, with the esophageal wall injured during the procedure and a hematoma developed on the wall.


EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
A P Martin ◽  
M Fowler ◽  
N Lever

Abstract Background Pulmonary vein isolation using cryotherapy is an established treatment for the management of patients with paroxysmal atrial fibrillation. Ablation using the commercially available balloon cryocatheter has been shown to create wide antral pulmonary vein isolation. A novel balloon cryocatheter (BCC) has been designed to maintain uniform pressure and size during ablation, potentially improving contact with the antral anatomy. The extent of ablation created using the novel BCC has not previously been established. Purpose To determine the anatomical extent of pulmonary vein isolation using electroanatomical mapping when performing catheter ablation for paroxysmal atrial fibrillation using the novel BCC. Methods Nine consecutive patients underwent pre-procedure computed tomography angiography of the left atrium to quantify the chamber dimensions. An electroanatomical map was created using the cryoablation system mapping catheter and a high definition mapping system. A bipolar voltage map was obtained following ablation to determine the extent of pulmonary vein isolation ablation. A volumetric technique was used to quantify the extent of vein and posterior wall electrical isolation in addition to traditional techniques for proving entrance and exit block. Results All patients had paroxysmal atrial fibrillation, mean age 56 years, 7 (78%) male. Electrical isolation was achieved for 100% of the pulmonary veins; mean total procedure time was 109 min (+/- 26 SD), and fluoroscopy time 14.9 min (+/- 2.4 SD). The median treatment applications per vein was one (range one - four), and median treatment duration 180 sec (range 180 -240). Left atrial volume 32 mL/m2 (+/- 7 SD), and mean left atrial posterior wall area 22 cm2 (+/- 4 SD). Data was available for quantitative assessment of the extent of ablation for eight patients. No lesions (0 of 32) were ostial in nature. The antral surface area of ablation was not statistically different between the left and right sided pulmonary veins (p 0.63), which were 5.9 (1.6 SD) and 5.4 (2.1 SD) cm2 respectively. In total 50% of the posterior left atrial wall was ablated.  Conclusion Pulmonary vein isolation using a novel BCC provides a wide and antral lesion set. There is significant debulking of the posterior wall of the left atrium. Abstract Figure.


Author(s):  
Filip Casselman ◽  
Ihsan Bakir ◽  
Pedro Brugada ◽  
Peter Geelen ◽  
Francis Wellens ◽  
...  

Objective To evaluate the feasibility and results of isolated endoscopic pulmonary vein isolation for paroxysmal atrial fibrillation using robotics. Methods Between November 2004 and December 2005, 13 patients (38.5% female) underwent robotic pulmonary vein isolation at our institution. Mean age was 46.8 ± 8.4 years and mean preoperative duration of atrial fibrillation was 52.7 ±31.5 months. Indication for surgery was symptomatic drug-refractory paroxysmal atrial fibrillation or recurrence after percutaneous treatment (n = 3). Mean preoperative left atrial dimension was 38.5 ± 6.9 mm. The surgical procedure was performed off-pump as an isolated right chest approach. All procedures were performed using the Flex 10 microwave ablator (Guidant, Indianapolis, IN), which was positioned from the right side through the transverse sinus and around the 4 pulmonary veins. Postoperative drug regimen included sotalol and Coumadin. Mean follow-up was 8.5 ± 3.4 months. Results The procedure was successful in 11 patients. One patient needed conversion to median sternotomy for right pulmonary artery bleeding and a second patient had severe transverse sinus adhesions requiring conversion to a bilateral video-assisted small thoracotomy approach. No other morbidity occurred. Mean procedure time in successful cases was 2.7 ± 0.8 hours (range 1.7 to 4 hours). Permanent sinus rhythm was successfully restored in 10 of 13 patients (76.9% beyond 6 months). Nonsuccessful patients had markedly reduced symptoms and frequency of events. One patient required a left and another a right atrial flutter ablation during follow-up. Conclusions Robotic pulmonary vein isolation is a feasible procedure that has the potential to become a valid option in the treatment of paroxysmal atrial fibrillation.


Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 3695-3695
Author(s):  
James R. Berenson ◽  
John B Tillman ◽  
Mohamad A. Hussein ◽  
Robert Pflugmacher ◽  
Peter Jarzem ◽  
...  

Abstract Destructive vertebral lesions are a common source of morbidity among patients with cancer. Balloon kyphoplasty is a minimally invasive surgical procedure performed for patients with painful vertebral compression fractures (VCFs) with the goal of reducing pain and disability and improving quality of life. We report the results of the first randomized trial among cancer patients with VCFs to assess the efficacy and safety of this procedure. Twenty-one sites in Europe, the United States, Canada and Australia enrolled 134 patients after consent and ethical review board approval. Adult patients diagnosed with a variety of cancers and ≤ 3 painful VCFs (VAS ≥ 4) were randomly assigned to immediate kyphoplasty (N=70) or nonsurgical supportive care (N=64). Patients with primary bone tumors, osteoblastic tumors or solitary plasmacytoma at the fracture site were excluded as well as patients with spinal cord compression. The primary objective was to determine the change in the Roland-Morris Disability questionnaire, a 0- (no disability) to 24-point (maximum disability) instrument validated for assessing back-specific physical functioning, at one month. Back pain was also assessed using a validated 0- (no pain) to 10-point (worst pain imaginable) numerical rating scale. Data from a preplanned interim analysis of this ongoing study are now reported. For pain and function, patients with complete data that has been evaluated through one month are included whereas all enrolled patients were analyzed for safety. Mean patient age was 64 years (range 37 to 88), 58% were female, and tumor types included multiple myeloma (36%), cancers of the breast (20%), lung (8%), prostate (6%) and other sites (30%). At study enrollment, 23% of patients were on daily corticosteroids and 48% had received bisphosphonates within 12 months of study entry. Prior to randomization, single VCFs were identified by the local investigators in 43% of patients; an equal proportion (29%) of patients had 2 or 3 fractures. Among the kyphoplasty and nonsurgical cohorts, 59 and 56 subjects, respectively were evaluable for the efficacy analysis. At baseline, average Roland-Morris scores were similar between the groups; 17.7 and 18.3 points for kyphoplasty and non-surgical-treated patients, respectively. However, at one month, there were marked differences between the two groups with a mean improvement for patients randomized to kyphoplasty of −8.3 points (95% CI −6.2 to −10.5) whereas those receiving non-surgical care showed no significant change (−0.1 points, 95% CI 0.9 to −1.0; p<0.0001 for difference). Mean baseline pain scores were also not different between the two groups (7.2 and 7.3 points for the kyphoplasty and nonsurgical groups, respectively). At one week, kyphoplasty-treated patients showed significant improvement in their back pain (−3.6 points, 95%CI, −2.8 to −4.4) whereas those patients treated non-surgically had no change in their pain (−0.3 points, 95%CI, 0.1 to −0.8; p<0.0001 for difference). Similar results for pain were obtained at one month; kyphoplasty resulted in a −4.1 point change (95%CI, −3.2 to −4.9) and those patients treated non-surgically had no change in their pain (−0.5 points; 95%CI, 0.04 to −1.0; p<0.0001 for difference). There was no significant difference in the number of patients with serious adverse events between the kyphoplasty (16) and nonsurgical (10) groups at one month. None of the serious adverse events in the kyphoplasty group were related to the devices used, including bone cement extravasation; one serious adverse event in the form of an intra-operative non-Q-wave myocardial infarction resolved and was attributed to anesthesia. This randomized study shows, at a pre-planned interim analysis time point, that patients with cancer-related VCFs treated with immediate balloon kyphoplasty show a marked reduction in back disability and pain at one month compared to non-surgical treatment. Pain reduction was also statistically significantly improved within one week postoperatively. Importantly, minimally clinically important differences for the Roland-Morris and pain scales used in this trial have been determined from previous studies and are estimated to be approximately 2.5 and 2.0 points, respectively. Thus, these improvements in disability and pain with balloon kyphoplasty were both statistically and clinically significant and achieved without an increase in adverse events.


Author(s):  
Yue Song ◽  
Jingjing Zheng ◽  
Lianhui Fan

Background Esophageal ulceration and fistula are severe complications of pulmonary vein isolation using thermal ablation. Nonthermal irreversible electroporation (NTIRE) is a promising new technology for pulmonary vein isolation in patients with atrial fibrillation. NTIRE ablation technology has been used to treat atrial fibrillation; however, the effects of NTIRE on esophageal tissue have not been clearly described. Methods and Results A typical NTIRE electrical protocol was directly applied to esophagi in 84 New Zealand rabbits. Finite element modeling and histological analysis with 120 slices were used to analyze electric field intensity distribution and subsequent tissue changes. A parameter combination of 2000 V/cm multiplied by 90 pulses output is determined to be an effective ablation parameters combination. Within 16 weeks after ablation, no obvious lumen stenosis, epithelial erythema, erosion, ulcer, or fistula was observed in the esophageal tissue. NTIRE effectively results in esophageal cell ablation to death, and subsequently, signs of recovery gradually appear: creeping replacement and regeneration of epithelial basal cells, repair and regeneration of muscle cells, structural remodeling of the muscle layer, and finally the restoration of clear anatomical structures in all layers. Conclusions Monophasic, bipolar NTIRE delivered using plate electrodes in a novel esophageal injury model demonstrates no histopathologic changes to the esophagus at 16 weeks. Data of this study suggest that electroporation ablation is a safe modality for pulsed electroporation ablation near the esophagus.


2020 ◽  
Vol 33 (2) ◽  
pp. 106-114
Author(s):  
Michele Brunelli ◽  
Mark Adrian Sammut

Catheter ablation of long-standing persistent atrial fibrillation is not yet clearly defined with respect to endpoints, and different ablative strategies are offered to patients. Presented here is an approach aiming at biatrial debulking in the form of extensive linear ablation, specifically targeting areas of low-voltage complex fractionated electrograms, in addition to pulmonary vein isolation. Its main advantage is that it is not dependent on operator/system variability, since the strategy of isolating the pulmonary veins, superior vena cava and left atrial posterior wall together with achievement of bidirectional block during linear ablation provides objective endpoints that can consistently be reproduced.


Author(s):  
Sapan Bhuta ◽  
Gustaf Sverin ◽  
Hiro Kawata ◽  
Malek Bashti ◽  
Jessica Hunter ◽  
...  

Background: Previous studies suggest that wide area circumferential pulmonary vein ablation (WACA) is more effective than segmental pulmonary vein ablation (SPVA) for pulmonary vein isolation (PVI) for treatment of atrial fibrillation. Whether this is true in patients (pts) with very short duration paroxysmal atrial fibrillation (PAF) is unknown. Objective: To compare WACA to SPVA in pts with PAF lasting <48 hours. Methods: One hundred pts with PAF <48 hours were randomized to either WACA vs SPVA (45 and 53 pts respectively, with 2 withdrawals), and followed up for 24 months with 14-day ECGs every 6 months. Results: Among 97 pts at an average of 22.1±4.8 months followup, 26 (57.8%) remained free of any atrial arrhythmias after WACA versus 29 (55.86%) after SPVA (p=0.64). Sixteen pts (35.6%) had recurrent PAF after WACA versus 20 pts (38.5%) after SPVA (p=0.79). Seven pts (15.6%) had atrial flutter after WACA versus 5 pts (9.64%) after SPVA (p=0.376) and 1 pt (2.2%) had atrial tachycardia after WACA vs 1 pt (1.9%) after SPVA (p=0.918). Total procedure time was lower for SPVA vs WACA (242.9 vs 271.1 minutes, p= 0.047), and fluoroscopy time similar for WACA vs SPVA (50.8 vs 53.4 minutes, p=0.555). Conclusions: As an initial ablation approach in pts with PAF <48 hours, SPVA was similarly effective to WACA with respect to arrhythmia recurrence, supporting the central role of the pulmonary veins for maintaining AF in these pts. Future therapies using alternative ablation energies may incorporate these insights to reduce risk to gastroesophageal structures.


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