P2846Focal impulse and rotor modulation ablation versus pulmonary vein isolation for the treatment of paroxysmal atrial fibrillation (FIRMAP AF study)

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
R Tilz ◽  
C L Lenz ◽  
P S Sommer ◽  
N Sawan ◽  
R Meyer-Saraei ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Pulmonary Vein ◽  
Pulmonary Vein Isolation ◽  
Paroxysmal Atrial Fibrillation ◽  
Gold Standard ◽  
Artery Aneurysm ◽  
Rf Ablation ◽  
Af Ablation ◽  
Number Of Patients

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

scholarly journals Clinical success of cryoballoon pulmonary vein isolation in patients with atrial fibrillation

2019 ◽  
Vol 7 (4S) ◽  
pp. 6-14
Author(s):  
T. Y. Chichkova ◽  
S. E. Mamchur ◽  
E. A. Khomenko
Keyword(s):  
Atrial Fibrillation ◽  
Pulmonary Vein ◽  
Pulmonary Vein Isolation ◽  
Direct Current ◽  
Clinical Success ◽  
Persistent Atrial Fibrillation ◽  
Cryoballoon Ablation ◽  
Clinical Effects ◽  
Rf Ablation

Aim. To estimate the clinical success of cryoballoon pulmonary vein isolation (PVI).Methods.230 patients (males: 49.6%, mean age 57 (53; 62) with symptomatic paroxysmal and persistent atrial fibrillation (AF) resistant to antiarrhythmic therapy were included in a single-center prospective study. The patients were randomized into 2 groups to undergo either cryoballoon ablation (n = 122) or radiofrequency (RF) (n = 108) ablation. Both groups were comparable in baseline parameters. The follow-up period was 12 months. Clinical outcomes were estimated with the use of a three-stage scale. The rates of cardiovascular rehospitalizations, direct-current cardioversions and repeated ablations during were estimated within the follow-up. The quality of life (QoL) in the cryoablation group was measured using the AFEQT scale.Results.77% (n = 94) of patients in the cryoballoon ablation group and 71.3% (n = 77) of patients in the RF group (р = 0.71) demonstrated reported the optimal clinical effects. Both groups, cryo ablation and RF ablation, had similar rates of cardiovascular hospitalizations (23.8 vs 28.7%, OR 0.8, 95% CI 0.4–1.4; р = 0.39), direct-current cardioversions (12.3 vs 17.6%, OR 0.7, 95% CI 0.3–1.4; р = 0.26) and repeated ablations (9.8–11.1%, OR 0.9, 95% CI 0.4–2.0; р = 0.75). The patients treated with cryoballoon as opposed to RF ablation had significantly more successful usage of “pill-in-pocket” strategy – 14.8 vs 6.5% (OR 2.5, 95% CI 1.01–6.2; р = 0.04). Significant improvements of the QoL parameters with strong size effect have been found in the cryoablation group, i.e. global score (GS) increased by 8.9±6.9 (95% CI 6.6–10.1; dCohen 1.2; р<0.001), symptoms (S) – by 8.3±7.9 (95% CI 4.2–8.8; dCohen 1.5; р<0.001), daily activities (DA) – by 10.0±6.9 (95% CI = 6.4–10.6; dCohen 0.9; р<0.001), treatment concerns (TC) – by 5.5±6.0 (95% CI 6.3–9.2; dCohen 1.2; р<0.001) and treatment satisfaction (TS) – by 5.5±6.0 (95% CI 5.4–9.8; dCohen 0.9; р<0.001).Conclusion.The both catheter-based technologies had comparable clinical success. Cryoablation was characterized by improvement in all QoL parameters based on the AFEQT score.

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

2006 ◽  
Vol 1 (5) ◽  
pp. 247-250
Author(s):  
Filip Casselman ◽  
Ihsan Bakir ◽  
Pedro Brugada ◽  
Peter Geelen ◽  
Francis Wellens ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Pulmonary Vein ◽  
Pulmonary Vein Isolation ◽  
Paroxysmal Atrial Fibrillation ◽  
Pulmonary Veins ◽  
Median Sternotomy ◽  
Transverse Sinus ◽  
Right Atrial ◽  
Off Pump

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.

scholarly journals Cryoballoon Versus High-Power, Short-Duration Radiofrequency Ablation for Pulmonary Vein Isolation in Patients With Paroxysmal Atrial Fibrillation

2021 ◽  
Vol 14 (9) ◽  
Author(s):  
Hui-Nam Pak ◽  
Je-Wook Park ◽  
Song-Yi Yang ◽  
Tae-Hoon Kim ◽  
Jae-Sun Uhm ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Heart Rate ◽  
Heart Rate Variability ◽  
Pulmonary Vein ◽  
Pulmonary Vein Isolation ◽  
High Power ◽  
Paroxysmal Atrial Fibrillation ◽  
Antiarrhythmic Drugs ◽  
Procedure Time

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.

Abstract 2752: Pulmonary Vein Isolation With And Without Additional Ablation Of Complex Fractionated Electrograms In Paroxysmal Atrial Fibrillation: Long-term Results Of A Prospective Randomized Study

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Isabel Deisenhofer ◽  
Tilko Reents ◽  
Heidi L Estner ◽  
Stephanie Fichtner ◽  
Christian von Bary ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Pulmonary Vein ◽  
Pulmonary Vein Isolation ◽  
Paroxysmal Atrial Fibrillation ◽  
Randomized Study ◽  
Intention To Treat ◽  
Long Term Follow Up ◽  
Treat Analysis

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.

scholarly journals Long-Term Follow-Up After Cryothermic Ostial Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation

2008 ◽  
Vol 51 (8) ◽  
pp. 850-855 ◽  
Author(s):  
Wendel Moreira ◽  
Randy Manusama ◽  
Carl Timmermans ◽  
Benoit Ghaye ◽  
Suzanne Philippens ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Pulmonary Vein ◽  
Pulmonary Vein Isolation ◽  
Paroxysmal Atrial Fibrillation ◽  
Long Term Follow Up

scholarly journals Symptomatic paroxysmal atrial fibrillation in a patient with unilateral pulmonary vein atresia

2015 ◽  
Vol 3 (9) ◽  
pp. 49
Author(s):  
Sharmila Sehli ◽  
David M Donaldson
Keyword(s):  
Atrial Fibrillation ◽  
Pulmonary Vein ◽  
Paroxysmal Atrial Fibrillation ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Pulmonary Veins ◽  
Atrial Appendage ◽  
Electroanatomic Mapping System ◽  
Af Ablation ◽  
Number Of Patients

A 52-year-old man with symptomatic paroxysmal atrial fibrillation was offered an atrial fibrillation (AF) ablation procedure. His echocardiogram indicated that he had no structural heart disease. A cardiac computed tomographic (CT) scan showed enlargement of the right pulmonary veins, absence of the left pulmonary veins, a prominent left atrial appendage, and a hypoplastic left lung. Cardiac CT with an electroanatomic mapping system confirmed a prominent left atrial appendage and the absence of the left pulmonary veins. Due to the limited number of patients with this condition, information about ablation remains very limited, and his ablation was deferred. Unilateral pulmonary vein atresia is a rare condition in adults which results from failure of incorporation of the common pulmonary vein into the left atrium. This case demonstrates the clinical importance of preprocedural imaging prior to AF ablation.

scholarly journals Optimal single procedure strategy of pulmonary vein isolation with cryoballoon or radiofrequency and non-pulmonary vein triggers ablation for non-paroxysmal atrial fibrillation

2021 ◽  
Author(s):  
Giichi Nitta ◽  
Junichi Nitta ◽  
Osamu Inaba ◽  
Akira Sato ◽  
Yukihiro Inamura ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Pulmonary Vein ◽  
Pulmonary Vein Isolation ◽  
Paroxysmal Atrial Fibrillation ◽  
Propensity Scores ◽  
Rf Ablation ◽  
Limited Data ◽  
Combination Strategy ◽  
Kaplan Meier ◽  
Procedural Time

Introduction: Limited data exist on pulmonary vein isolation (PVI) using cryoballoon (CB) or radiofrequency (RF) ablation and additional non-pulmonary vein triggers ablation for non-paroxysmal atrial fibrillation (non-PAF). The objective of this study was to assess the outcomes of first-stage catheter ablation for non-PAF patients. Methods and Results: Initial PVI was performed on 734 non-PAF patients (age: 64±10 years; male: 584) between September 2014 and June 2018 [315 (43%), CB ablation; 419 (57%), RF catheter]. A logistic regression model was used to match 257 pairs (514 patients) according to propensity scores (CB group or RF group). After PVI, additional non-PV triggers ablation was performed if induced by isoproterenol. We analyzed the clinical outcomes of both groups. The mean procedural time was significantly shorter in the CB group (125 [range, 89–165] min) than in the RF group (190 [160–224] min; P < 0.001). The 1-year Kaplan-Meier event rate revealed similar atrial fibrillation-free survival rate between the groups (CB: 77.9%, RF: 82.3%; log-rank P = 0.111). The additional ablation percentage for non-PV foci (CB: 39%, RF: 41%; P = 0.653) and the complications incidence (CB: 5%, RF: 4%; P = 0.670) were also similar. Conclusion: In non-PAF patients, PVI using CB or RF ablation and non-PV triggers ablation achieved comparable outcomes. The safety and efficacy of the combination strategy of PVI and non-PV triggers ablation was demonstrated.

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