Initial Experience with Robotic Epicardial Off-Pump Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation

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.

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
R Tilz ◽  
C L Lenz ◽  
P S Sommer ◽  
N Sawan ◽  
R Meyer-Saraei ◽  
...  

Abstract Background Based on the assumption of trigger elimination, pulmonary vein isolation (PVI) currently presents the gold standard of atrial fibrillation (AF) ablation. Recently, rapidly spinning rotors or focal impulse formation has been raised as a crucial sustaining mechanism of AF. Ablation of these rotors may potentially obviate the need for trigger elimination with PVI. Purpose This study sought to compare the safety and effectiveness of Focal Impulse and Rotor Modulation (FIRM) guided catheter ablation only with the gold standard of pulmonary vein isolation (PVI) in patients with paroxysmal AF. Methods This was a post-market, prospective, single-blinded, randomized, multi-center trial. Patients were enrolled at three centers and equally (1:1) randomized between those undergoing conventional RF ablation with PVI (PVI group) vs. those treated with FIRM-guided RF ablation without PVI (FIRM group). Data was collected at enrollment, procedure, and at 7-day, 3-month, 6-month, and 12-month follow-up visits. The study was closed early by the sponsor. At the time of study closure, any pending follow-up visits were waived. Results From February 2016 until February 2018, a total of 51 (out of a planned 170) patients (mean age 63±10.6 years, 57% male) were enrolled and randomized. Four patients withdrew from the study prior to treatment, resulting in 23 patients allocated to the FIRM group and 24 in the PVI group. Only 13 patients in the FIRM group and 11 patients in the PVI group completed the 12-month follow-up. Statistical analysis was not completed given the small number of patients. Single-procedure effectiveness (freedom from AF/atrial tachycardia recurrence after blanking period) was 52.9% (9/17) in the FIRM group and 85.7% (12/14) in the PVI group at 6 months; and 31.3% (5/16) in the FIRM group and 80% (8/10) in the PVI group at 12 months. Repeat procedures were performed in 45.8% (11/24) patients in the FIRM group and 7.4% (2/27) in the PVI group. The acute safety endpoint [freedom from procedure-related serious adverse events (SAE)] was achieved in 87% (20/23) of FIRM group patients and 100% (24/24) of PVI group patients. Procedure related SAEs occurred in three patients in the FIRM group: 1 femoral artery aneurysm and 2 injection site hematomas. No additional procedure-related SAEs were reported >7 days post-procedure. Conclusions These partial study effectiveness results reinforce the importance of PVI in paroxysmal atrial fibrillation patients and suggest that FIRM-guided ablation alone (without PVI) is not an effective strategy for treatment of paroxysmal AF in most patients. Further study is needed to understand the effectiveness of adding FIRM-guided ablation as an adjunct to PVI in this patient group. Acknowledgement/Funding Abbot


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.


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.


Author(s):  
Hui-Nam Pak ◽  
Je-Wook Park ◽  
Song-Yi Yang ◽  
Tae-Hoon Kim ◽  
Jae-Sun Uhm ◽  
...  

Background: The efficacy of cryoballoon pulmonary vein isolation (Cryo-PVI) is equivalent to that of radiofrequency pulmonary vein isolation in patients with paroxysmal atrial fibrillation (AF). We aimed to compare the efficacy and safety profile of Cryo-PVI and high-power, short-duration (HPSD) radiofrequency catheter ablation (RFCA) in patients with AF. Methods: We prospectively randomized 314 patients with paroxysmal AF (men, 71.3%; 59.9±10.9 years old) to either the Cryo-PVI group (n=156) or HPSD-RFCA group (n=158). Cavotricuspid isthmus ablation and linear ablation from the superior vena cava to the right atrial septum in addition to pulmonary vein isolation were carried out in the majority of patients in the HPSD-RFCA group. The primary end point was AF recurrence after a single procedure; secondary end points were the recurrence pattern, cardioversion rate, follow-up heart rate variability, and response to antiarrhythmic drugs. Results: After a mean follow-up of 9.8±5.1 months, the clinical recurrence rate did not significantly differ between the two groups (log-rank P =0.840). The rate of recurrence as atrial tachycardia ( P >0.999), cardioversion ( P =0.999), and 3-month heart rate variability (high frequency; P =0.506) did not significantly differ. During the final follow-up, sinus rhythm was maintained without antiarrhythmic drugs in 70.5% of the Cryo-PVI group and 73.4% of the HPSD-RFCA group ( P =0.567). No significant difference was found in the major complication rate between the two groups (3.8% versus 0.6%; P =0.066), but total procedure time was significantly shorter in the Cryo-PVI group (78.5±20.2 versus 124.5±37.1 minutes; P <0.001). Conclusions: In patients with paroxysmal AF, the Cryo-PVI is an effective rhythm-control strategy with a shorter procedure time compared with the HPSD-RFCA. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03920917.


Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Isabel Deisenhofer ◽  
Tilko Reents ◽  
Heidi L Estner ◽  
Stephanie Fichtner ◽  
Christian von Bary ◽  
...  

Introduction: Segmental pulmonary vein isolation (PVI) leads to elimination of paroxysmal atrial fibrillation (AF) in approximately 75% of patients. Ablation of complex fractionated atrial electrograms (CFAE) is an alternative ablation strategy. In this prospective randomized study the long-term effect of PVI alone is compared to the effect of combined PVI and CFAE ablation in paroxysmal AF. Methods: 98 patients with paroxysmal AF (57±10 years, 74 male) were randomly assigned to PVI (48 patients) or PVI+CFAE ablation (50 patients). Additional CFAE ablation was performed in the PVI+CFAE group if AF was still inducible after PVI. Follow-up results were assessed with repetitive 7 days Holter ECG and clinical evaluation including repeat ablations. Results: Additional CFAE ablation was performed in 30/50 (60%) patients of the PVI+CFAE group with still inducible AF after PVI. In each group, 2 patients were lost to long term follow-up. In the intention-to-treat analysis at 3 months and after 19±8 months, there was no significant difference between both groups (36/48 [75%] and 34/46 [74%] patients in the PVI and 37/50 [73%] and 40/48 [83%] of patients in the PVI+CFAE ablation group in sinus rhythm [p=0.32]). In subgroup analysis, patients actually treated with the combined PVI+CFAE ablation approach had a significantly better long-term success (25/28; 89%) than patients with still inducible AF who underwent PVI only (22/30;73%; p=0.02). In both groups repeat ablations were performed in 31% (PVI group; 15/48 patients) and 35% (PVI+CFAE group; 17/48 patients) (p=n.s). After 9 months, significantly more patients in the PVI+CFAE group experienced sustained regular atrial tachycardia than in the PVI group (6/44 versus 1/39 patients, P=0.02). Conclusion: The combination of PVI and CFAE ablation was equally effective than PVI alone in reaching freedom of AF in the intention-to-treat analysis. During long-term follow-up, patients actually treated with combined PVI+CFAE ablation had a significantly better outcome (89% vs. 73%). However, the rate of ablation-induced regular atrial tachycardias is inreased.


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