scholarly journals Initial clinical experience of pulmonary vein isolation using the novel ultra-low temperature cryoablation catheter for patients with atrial fibrillation

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
S Tohoku ◽  
S Bordignon ◽  
S Chen ◽  
B Schmidt ◽  
K R J Chun

Abstract Background The high cooling power and ultra-low temperature cryoablation (ULTC) catheter called “Adagio” has been recently launched. A combination of a newly exploited cryogen and interchangeable stylet enables flexible and continuous lesion creation applicable not only for atrial fibrillation (AF) but also for other tachyarrhythmia by optimizing catheter shape. The exclusive esophageal warming balloon in order to preserve esophageal temperature is encouraged to prevent the potential risk of esophageal complication during procedure. Aim To assess the initial clinical data on pulmonary vein (PV) isolation for patients with AF using the novel ULTC catheter. Methods Consecutive patients who underwent AF ablation using ULTC in our center were enrolled. We assessed the acute procedural data focusing on procedural feasibility and safety comprising “first-pass isolation” defined as successful PV isolation after the initial application. Results A total of 16 AF patients (53% male, age 67 years, 59% paroxysmal AF) were analyzed. Sixty-six out of 67 PVs (98.5%) were isolated with ULTC. The mean number of applications per PV was 2.3 1.1. Touch-up catheter was needed in one case at left inferior PV. The mean total procedure and fluoroscopy times were 79±30 and 14±7 mins, respectively. First-pass isolation was achieved in 34 PVs (50.7%) varying across PVs from left superior PV (43.8%) to right superior PV (58.8%). In none of the patients an acute thromboembolic event (stroke or transient ischemic attack), a pericardial effusion/tamponade and postprocedural esophageal complication occurred. A single transient phrenic nerve weakening was observed at right superior PV. Conclusion Sequential PV isolation using the novel ULTC catheter was achieved feasibly without compromising safety. First-pass isolation was accomplished about in a half of PVs. FUNDunding Acknowledgement Type of funding sources: None.

Author(s):  
Shota Tohoku ◽  
Stefano Bordignon ◽  
Luca Trolese ◽  
Simone Zanchi ◽  
Lorenzo Bianchini ◽  
...  

Background: The endoscopic ablation system (EAS) is an established ablation device for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). The novel X3 EAS is now equipped with a contiguous circumferential ablation mode (RAPID mode). Aim: To determine the feasibility of single-sweep ablation using X3. Methods: Consecutive patients who underwent AF ablation using X3 were enrolled. We assessed the acute procedural data focusing on “Single-sweep PVI” defined as PVI with a single energy application using RAPID mode to complete the circular lesion set, and on “first-pass isolation” defined as successful visually guided PVI after initial circular lesion set. Results: One-hundred AF patients (56% male, age 68±10 years, 66% paroxysmal AF) were analyzed. A total of 379 of 383 PVs (99%) were isolated with X3. Single-sweep isolation and first-pass-isolation were achieved in 214 PVs (56%) and in 362 PVs (95%), respectively. Single-sweep isolation rates varied across PVs with higher rates at the superior PVs (61.2% vs. inferior PVs:49.5%, P=0.0239) and at PVs with maximal ostial diameter <24mm (57.6% vs. >24mm: 36.8%, P=0.0151). The mean total procedure and fluoroscopy times were 43.0±10 and 4.0±2 mins, respectively. In none of the patients an acute thromboembolic event (stroke or transient ischemic attack) or a pericardial effusion/tamponade occurred. A single transient phrenic nerve palsy was observed. Conclusion: The new X3 EAS allows for single-sweep PVI in 56% of PVs. The new RAPID ablation mode leads to an improved rate of first-pass isolation associated with very short procedure times without compromising safety.


Author(s):  
Robbert Ramak ◽  
Gian-Battista Chierchia ◽  
Gaetano Paparella ◽  
Cinzia Monaco ◽  
Vincenzo Miraglia ◽  
...  

Abstract Purpose The purpose of this study was to evaluate the safety and feasibility of the new high-resolution mapping algorithm SuperMap (Acutus Medical, CA, USA) in identifying and guiding ablation in the setting of regular atrial tachycardias following index atrial fibrillation (AF) ablation. Methods Seven consecutive patients who underwent a radiofrequency catheter ablation guided by the novel noncontact charge density (CD) SuperMap for atrial tachycardia were prospectively enrolled in our study. Results Arrhythmogenic substrate was identified in all seven patients. Mean number of EGM per map was 5859.7 ± 4348.5 points. Three patients (43%) exhibited focal tachycardia mechanisms in the left atrium, alternating from anteroseptal right superior pulmonary vein (RSPV), posterior in proximity of left inferior pulmonary vein (LIPV), and interarial septum in proximity of fossa ovalis, respectively. Four patients exhibited macroreentrant mechanism. In 3 of these patients, SuperMap detected mitral isthmus-dependent flutters with tachycardia cycle lengths of 240, 270 and 420 ms, respectively. In one patient, the mechanism was a macroreentrant tachycardia with the critical isthmus located between the crista terminalis and atriotomy. The mean ablation time (min) was 18.2 ± 12.5 and the mean procedural duration time was 56.4 ± 12.1 min. No minor or major complications occurred. Conclusion The novel high-resolution mapping algorithm SuperMap proved to be safe, fast, and feasible in identifying and guiding ablation in the setting of regular atrial tachycardias following index AF ablation.


EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
C Tondo ◽  
G Stabile ◽  
P Filannino ◽  
M Moltrasio ◽  
A De Simone ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Background Complete electrical pulmonary vein isolation (PVI) by cryo-balloon approach is a well-established ablation strategy of atrial fibrillation (AF). Recently, a new cryoablation system (POLARx) with unique features has been made available for clinical use. To date, no data exist on procedural characteristics of this system in a multicentric clinical practice. Purpose We aimed to characterize the initial experience of this technology in the Italian clinical practice. Methods Consecutive patients (pts) undergoing AF ablation from the CHARISMA registry at 5 Italian centres were included. Protocol-directed cryoablation was delivered for 180 sec or 240 sec according to operator’s preference for isolation achieved in ≤60 sec, or 240 sec if isolation occurred &gt;60 sec or when time to isolation (TTI) was not available. The ablation endpoint was PV isolation as assessed by entrance and exit block. Results Two-hundred sixty-two cryoapplications from 49 pts (194 PVs) were analyzed. PVI was achieved with cryoablation only in all pts. The mean number of freeze applications per pt was 5.3 ± 1.5 (1.3 ± 0.6 for LIPV, LSPV and RSPV, 1.6 ± 1.3 for RIPV), with 143 (73.7%) PVs treated in a single-shot fashion (38, 19.6% with 2 shots; 13, 6.7% with more than 2 shots). Sixteen (33%) pts were treated with a single freeze to each of the PVs. The mean nadir temperature was -55.5 ± 6.9 °C and was colder than -50°C in 83% of the PVs. TTI information was evaluable in 120 (46%) cryoapplications with a median TTI of 47 [32-75] sec (median temperature at TTI = -49 [-53 to -42] °C). The mean time to target -40 °C (TTT) was 30.1 ± 6.9 sec with a TTT &lt; 60 sec achieved in 99.2% of the cryoapplications; the mean thaw time to 0 °C was 18.6 ± 5.8 sec (thaw time &gt;15 sec in 70.3% of the cryoapplications). The mean PV occlusion grade (rank 1-4) was 3.6 ± 0.6 (grade 2 in 5.2% of the cases, grade 3 in 25.6% and grade 4 in 69.2%). No complications were observed at 30 days post-procedure. Conclusion In this first multicentric experience in a clinical practice setting, the novel cryo-balloon system proved to be safe and effective and resulted in a high proportion of successful single-freeze isolation. Cooling parameters seem to be slightly different from reference cryo-balloon technology.


EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
P Loh ◽  
MHA Groen ◽  
K Taha ◽  
FHM Wittkampf ◽  
PA Doevendans ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Abbott Background Irreversible electroporation (IRE) is a promising new non-thermal ablation technology for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). First in human studies demonstrated the feasibility and safety of IRE PVI. Objective Further investigate the safety of IRE PVI. Methods Twenty patients with symptomatic AF underwent IRE PVI under conscious sedation. Oral anticoagulation was uninterrupted and heparin was administered to maintain activated clotting time at 300-350 seconds. Non-arcing, non-barotraumatic 6 ms, 200 J IRE applications were delivered via a custom non-steerable 8 F, 14-polar circular IRE ablation catheter with a variable hoop diameter (16-27 mm). Voltage mapping  of the left atrium and the PVs was performed before and after ablation with a conventional circular mapping catheter. For both catheters a single transseptal access (8 F introducer, Agilis NxTTM) was used. Adenosine testing was performed after a 30-minute waiting period. On day 1 after ablation, patients underwent esophagoscopy and brain MRI (DWI/FLAIR). If abnormalities were detected, examinations were repeated in due time. Results In 20 patients, all 80 PVs could be successfully isolated with a mean of 11,8 ± 1,4 IRE applications per patient. Average time from first to last IRE application was 22 ± 5 minutes, total procedure duration was 107 ± 13 minutes and total fluoroscopy time was 23 ± 5 minutes. One PV reconnection occurred during adenosine testing, re-isolation was achieved with 2 additional IRE pulses. No periprocedural complications were observed. Brain MRI on day 1 after ablation showed punctate asymptomatic lesions in 3/20 patients (15%). At follow-up MRI the lesion disappeared in 1 patient while in the other 2 patients 1 lesion persisted. Esophagoscopy on day 1 showed an asymptomatic esophageal lesion in 1/20 patients (5%), at repeat esophagoscopy on day 22 the lesion had resolved completely. Conclusion Acute electrical PV isolation could be achieved safely and rapidly by IRE ablation under conscious sedation in 20 patients with symptomatic AF. Acute silent cerebral lesions were detected in 3/20 patients (15%) and may be due to ablation or to changes of therapeutic and diagnostic catheters over a single transseptal access.


2021 ◽  
Vol 2103 (1) ◽  
pp. 012049
Author(s):  
A V Pushkarev ◽  
N A Andreev

Abstract The article presents the results of a study of low-temperature exposure on animal biological tissue using the novel prototype of a liquid nitrogen cryoapplicator. The data obtained are compared with the cryoapplicator characteristics cooled by nitrogen dioxide that are currently used for the atrial fibrillation treatment. Data analysis confirmed the liquid nitrogen cryoapplicators effectiveness and made it possible to highlight their advantages.


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.


PeerJ ◽  
2016 ◽  
Vol 4 ◽  
pp. e1579 ◽  
Author(s):  
Wiesława Klimek-Piotrowska ◽  
Mateusz K. Hołda ◽  
Katarzyna Piątek ◽  
Mateusz Koziej ◽  
Jakub Hołda

Background.It is well known that the pulmonary veins (PVs), especially their myocardial sleeves play a critical role in the initiation and maintenance of atrial fibrillation. Understanding the PV anatomy is crucial for the safety and efficacy of all procedures performed on PVs. The aim of this study was to present normal distal PV anatomy and to create a juxtaposition of all PV ostium variants.Methods.A total of 130 randomly selected autopsied adult human hearts (Caucasian) were examined. The number of PVs ostia was evaluated and their diameter was measured. The ostium-to-last-tributary distance and macroscopic presence of myocardial sleeves were also evaluated.Results.Five hundred forty-one PV ostia were identified. Four classical PV ostia patterns (two left and two right PVs) were observed in 70.8% of all cases. The most common variant was the classical pattern with additional middle right PV (19.2%), followed by the common ostium for the left superior and the inferior PVs (4.44%). Mean diameters of PV ostia (for the classical pattern) were: left superior = 13.8 ± 2.9 mm; left inferior = 13.3 ± 3.4 mm; right superior = 14.3 ± 2.9 mm; right inferior = 13.7 ± 3.3 mm. When present, the additional middle right PV ostium had the smallest PV ostium diameter in the heart (8.2 ± 4.1 mm). The mean ostium-to-last-tributary (closest to the atrium) distances were: left superior = 15.1 ± 4.6 mm; left inferior = 13.5 ± 4.0 mm; right superior = 11.8 ± 4.0 mm; right inferior = 11.0 ± 3.7 mm. There were no statistically significant differences between sexes in ostia diameters and ostium-to-last-tributary distances.Conclusion.Only 71% of the cases have four standard pulmonary veins. The middle right pulmonary vein is present in almost 20% of patients. Presented data can provide useful information for the clinicians during interventional procedures or radiologic examinations of PVs.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
M Boussoussou ◽  
B Vattay ◽  
B Szilveszter ◽  
M Kolossvary ◽  
M Vecsey-Nagy ◽  
...  

Abstract Introduction The CLOSE protocol is a novel contact-force guided technique for enclosing pulmonary veins in patients with atrial fibrillation (AF). Consistency and lesion contiguity are essential factors for procedural success. We sought to determine whether left atrial (LA) wall thickness (LAWT) and pulmonary vein (PV) dimensions as assessed by coronary CT angiography (CTA) could influence the efficacy of successful first-pass isolation using the CLOSE protocol. Methods In a single center, prospective study we enrolled 94 patients with symptomatic, drug-refractory AF who underwent pre-ablation left atrial CTA and initial radiofrequency catheter ablation between 2019.01–2020.09. The LA was divided into 11 regions when assessing LAWT. Additionally, the diameter and area of the PV orifices were obtained. First pass isolation was recorded separately for the right and left PVs. After the first pass ablation circles were ready, additional ablations were applied in those cases where first pass isolation was not achieved, to reach complete PV isolation. Predictors of successful first pass isolation were determined using logistic regression models that included anthropometrical, echocardiographic and CTA derived parameters. Results A total of 94 patients were included in the analysis with mean CHA2DS2-VASc score of 2.1±1.5 (mean age 62.4±12.6 years, 39.5% female). 61.7% were paroxysmal, 38.3 were persistent AF patients. Mean procedure times were 81.2±19.3 minutes. Complete isolation of all four PVs was achieved in 100% of patients. First-pass isolation rate was 76%, 71% and 54%, for the right PVs, left PVs and all four PVs, respectively. No difference was found regarding comorbidities and imaging parameters between those with and without first pass isolation. LAWT (mean of all 11 regions or separately) had no effect on the procedural outcome (all p&gt;0.05). Out of all assessed parameters, only RSPV diameter was associated with right sided successful PVI on first pass isolation (p=0.04, OR 1.01). Conclusion The use of CLOSE protocol in AF patients resulted in high periprocedural success rate in terms of first pass isolation, independently from the thickness of the LA wall. RSPV diameter could influence the results of first pass isolation. FUNDunding Acknowledgement Type of funding sources: None.


EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
V Schillaci ◽  
G Stabile ◽  
A Arestia ◽  
G Shopova ◽  
F Solimene

Abstract Funding Acknowledgements Type of funding sources: None. Background. Fluoroscopy is commonly used in cryoballoon catheter ablation for pulmonary vein (PV) isolation procedures in patients with atrial fibrillation (AF). Objective The purpose of this study was to verify the feasibility of a new dielectric imaging system in reducing the radiation exposure during cryoballoon ablation in patients with AF. Methods We enrolled 26 consecutive patients with paroxysmal AF: 13 patients underwent the procedure under fluoroscopy guidance before the new system introduction, while 13 patient underwent the procedure under fluoroscopy and KODEX-EPD system guidance with its occlusion tool software. After transseptal access a detailed image reconstruction of left atrium and PVs was achieved with the Achieve octapolar circular mapping catheter and the cryoablation was performed with the Arctic Front Advance cryoballoon. Results Total time of the procedure was comparable between the two groups (90.15 ± 28.67 vs 80.77 ± 17.17 using KODEX-EPD, p = 0.34), while fluoroscopy time was significantly lower in the group using KODEX-EPD (16.92 ± 8.96 vs 5.54 ± 2.06, p &lt; 0.01). Acute isolation was achieved in all PVs. No 30 days complication was observed. Conclusion This is the first study that demonstrates the feasibility of a reduce fluoroscopy workflow using the novel KODEX-EPD system in a cryoballoon procedure. Abstract Figure. Fluoroscopy time


EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
P Futyma ◽  
L Zarebski ◽  
A Wrzos ◽  
M Futyma ◽  
P Kulakowski

Abstract Funding Acknowledgements Type of funding sources: None. Background Pulmonary vein isolation (PVI) is a cornerstone for catheter ablation (CA) of atrial fibrillation (AF), however, long-term efficacy of PVI is frequently below expectations. PVI is invasive, expensive and may be associated with devastating complications. It has been postulated that vagally-mediated AF can be treated by attenuation of parasympathetic drive to the heart using cardioneuroablation by means of radiofrequency CA (RFCA) of the right anterior ganglionated plexus (RAGP), however, data in literature and guidelines are lacking. Purpose To examine the efficacy of RFCA targeting RAGP without PVI in management of vagal AF. Methods We included consecutive 9 male patients with vagal AF who underwent RFCA of RAGP without PVI. RAGP was targeted anatomically from the right atrium (RA) at the postero-septal area below superior vena cava (SVC) and from the left atrium (LA) if needed. The aim was to achieve &gt;30% increase in heart rate (HR) . The follow up consisted of regular visits and Holter ECG conducted every 3 months. Results A total number of 9 patients (age 52 ± 13) with vagally-mediated AF underwent RFCA of RAGP (mean RAGP RF time 147 ± 85, max power 34 ± 8W). The mean procedure time was 60 ± 29min. HR increase &gt;30% was achieved in 8 (89%) patients (pre-RF vs post-RF: 58 ± 8bpm vs 87 ± 12bpm, p = 0.00002) . Transseptal  to reach RAGP also from the LA was needed in 2 (22%) patients. There were no major complications during the procedures. The follow up lasted 6 ± 2 months. Antiarrhythmic drugs were discontinued in 8 (89%) patients. There was 1 (11%) AF recurrence in the patient in whom targeted HR acceleration during RFCA was not achieved. B-blockers were administered in  6 (67%) patients due to increased HR and such treatment was well tolerated by all. Conclusions Catheter ablation of RAGP without performing PVI is feasible and can be effective in majority of patients with vagally-mediated AF. Increased HR after such cardioneuroablation can be well controlled using b-blockers and is usually associated with mild symptoms. The role of cardioneuroablation for treatment of vagally-mediated AF needs to be determined in prospective trials. Abstract Figure. Cardioneuroablation in vagal AF


Sign in / Sign up

Export Citation Format

Share Document