Complications in pulmonary vein isolation in the Netherlands Heart Registration differ with sex and ablation technique

Abstract Aims Pulmonary vein isolation (PVI) has become a cornerstone of the invasive treatment of atrial fibrillation. Severe complications are reported in 1–3% of patients. This study aims to compare complications and follow-up outcome of PVI in patients with atrial fibrillation. Methods and results The data were extracted from the Netherlands Heart Registration. Procedural and follow-up outcomes in patients treated with conventional radiofrequency (C-RF), multielectrode phased RF (Ph-RF), or cryoballoon (CB) ablation from 2012 to 2017 were compared. Subgroup analysis was performed to identify variables associated with complications and repeat ablations. In total, 13 823 patients (69% male) were included. The reported complication incidence was 3.6%. Patients treated with C-RF developed more cardiac tamponades (C-RF 0.8% vs. Ph-RF 0.3% vs. CB 0.3%, P ≤ 0.001) and vascular complications (C-RF 1.7% vs. Ph-RF 1.2% vs. CB 1.3%, P ≤ 0.001). Ph-RF was associated with fewer bleeding complications (C-RF: 1.0% vs. Ph-RF: 0.4% vs. CB: 0.7%, P = 0.020). Phrenic nerve palsy mainly occurred in patients treated with CB (C-RF: 0.1% vs. Ph-RF: 0.2% vs. CB: 1.5%, P ≤ 0.001). In total, 18.4% of patients were referred for repeat ablation within 1 year. Female sex, age, and CHA2DS2-VASc were independent risk factors for cardiac tamponade and bleeding complications, with an adjusted OR for female patients of 2.97 (95% CI 1.98–4.45) and 2.02 (95% CI 1.03–4.00) respectively. Conclusion The reported complication rate during PVI was low. Patients treated with C-RF ablation were more likely to develop cardiac tamponades and vascular complications. Female sex was associated with more cardiac tamponade and bleeding complications.

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B-PO02-073 ONE-YEAR FOLLOW-UP AFTER WIDE-AREA PULMONARY VEIN ISOLATION USING THE VISUALLY GUIDED LASER BALLOON FOR ATRIAL FIBRILLATION

Heart Rhythm ◽

10.1016/j.hrthm.2021.06.328 ◽

2021 ◽

Vol 18 (8) ◽

pp. S125-S126

Author(s):

Takashi Yamasaki ◽

Tetsuhisa Hattori Keisuke Ohta ◽

Nobuyuki Miyai, Reo Nakamura ◽

Takayoshi Sawanishi Noriyuki Kinosita ◽

Ken Kakita

Keyword(s):

Atrial Fibrillation ◽

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Wide Area ◽

Visually Guided ◽

One Year ◽

Laser Balloon

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Real-time local impedance monitoring to assess tissue lesion during pulmonary vein isolation: a new tool for AF ablation

European Heart Journal ◽

10.1093/ehjci/ehaa946.0562 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

A Di Cori ◽

L Segreti ◽

G Zucchelli ◽

S Viani ◽

F Tarasco ◽

...

Keyword(s):

Atrial Fibrillation ◽

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Contact Force ◽

Vascular Complications ◽

Lesion Formation ◽

Tissue Impedance ◽

Af Ablation ◽

Group 2 ◽

Group 1

Abstract Background Contact force catheter ablation is the gold standard for treatment of atrial fibrillation (AF). Local tissue impedance (LI) evaluation has been recently studied to evaluate lesion formation during radiofrequency ablation. Purpose Aim of the study was to assess the outcomes of an irrigated catether with LI alghorithm compared to contact force (CF)-sensing catheters in the treatment of symptomatic AF. Methods A prospective, single-center, nonrandomized study was conducted, to compare outcomes between CF-AF ablation (Group 1) and LI-AF ablation (Group 2). For Group 1 ablation was performed using the Carto 3© System with the SmartTouch SF catheter and, as ablation target, an ablation index value of 500 anterior and 400 posterior. For Group 2, ablation was performed using the Rhythmia™ System with novel ablation catheter with a dedicated algorithm (DirectSense) used to measure LI at the distal electrode of this catheter. An absolute impedance drop greater than 20Ω was used at each targeted. According to the Close Protocol, ablation included a point by point pulmonary vein isolation (PVI) with an Inter-lesion space ≤5 mm in both Groups. Procedural endpoint was PVI, with confirmed bidirectional block. Results A total of 116 patients were enrolled, 59 patients in Group 1 (CF) and 57 in Group 2 (LI), 65 (63%) with a paroxismal AF and 36 (37%) with a persistent AF. Baseline patients features were not different between groups (P=ns). LI-Group showed a comparable procedural time (180±89 vs 180±56, P=0.59) but with a longer fluoroscopy time (20±12 vs 13±9 min, P=0.002). Wide antral isolation was more often observed in CF-Group (95% vs 80%, P=0.022), while LI-Group 2 required frequently additional right or left carina ablation (28% vs 14%, P=0.013). The mean LI was 106±14Ω prior to ablation and 92.5±11Ω after ablation (mean LI drop of 13.5±8Ω) during a median RF time of 26 [19–34] sec for each ablation spot. No steam pops or complications during the procedures were reported. The acute procedural success was 100%, with all PVs successfully isolated in all study patients. Regarding safety, only minor vascular complications were observed (5%), without differences between groups (p=0.97). During follow up, 9-month freedom from atrial fibrillation/atrial flutter/atrial tachycardia recurrence was 86% in Group 1 and 75% in Group 2 (P=0.2). Conclusions An LI-guided PV ablation strategy seems to be safe and effective, with acute and mid-term outcomes comparable to the current contact force strategy. LI monitoring could be a promising complementary parameter to evaluate not only wall contact but also lesion formation during power delivery. Procedural Outcomes Funding Acknowledgement Type of funding source: None

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Up to 6-year follow-up after pulmonary vein isolation for persistent/permanent atrial fibrillation: Importance of sinus node function

Journal of Thoracic and Cardiovascular Surgery ◽

10.1016/j.jtcvs.2010.04.045 ◽

2011 ◽

Vol 141 (6) ◽

pp. 1455-1460 ◽

Cited By ~ 3

Author(s):

Yoshiharu Soga ◽

Hitoshi Okabayashi ◽

Yoshio Arai ◽

Takuya Nomoto ◽

Jota Nakano ◽

...

Keyword(s):

Atrial Fibrillation ◽

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Sinus Node ◽

Permanent Atrial Fibrillation

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Cryoballoon Atrial Fibrillation Ablation in a Patient with an Atrial Septal Defect Closure Device

The Journal of Tehran University Heart Center ◽

10.18502/jthc.v16i1.6602 ◽

2021 ◽

Author(s):

Meisam Mokhtari ◽

Zahra Khajali ◽

Mona Heidarali ◽

Majid Haghjoo

Keyword(s):

Atrial Fibrillation ◽

Atrial Septal Defect ◽

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Septal Defect ◽

Closure Device ◽

Atrial Septal Defect Closure ◽

Occluder Device ◽

Asd Closure

Atrial fibrillation (AF) is the most commonly treated arrhythmia in clinical practice and is often found in association with an atrial septal defect (ASD). However, ASD closure rarely confers complete arrhythmia control. A 23-year-old man presented to our center with frequent episodes of palpitations. AF was documented in 12-lead electrocardiography, and echocardiography showed a secundum-type ASD, 14 mm in size, with a significant left-to-right shunt. ASD closure was performed successfully with an ASD occluder device with no residual shunting. During follow-up, the patient experienced several episodes of AF. Thirteen months after the ASD closure, cryoballoon pulmonary vein isolation was done successfully with no complications. During a 12-month follow-up, he had no symptoms or AF recurrences, and echocardiography showed no residual shunting. This study showed that cryoballoon pulmonary vein isolation could be performed successfully without residual shunts in patients with ASD closure devices.

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

Complex Issues of Cardiovascular Diseases ◽

10.17802/2306-1278-2018-7-4s-6-14 ◽

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.

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

European Heart Journal ◽

10.1093/eurheartj/ehz748.1156 ◽

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

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Pulmonary vein isolation by radiosurgery: implications for non-invasive treatment of atrial fibrillation

EP Europace ◽

10.1093/europace/euu406 ◽

2015 ◽

Vol 17 (12) ◽

pp. 1868-1874 ◽

Cited By ~ 24

Author(s):

Frank Bode ◽

Oliver Blanck ◽

Maximilian Gebhard ◽

Peter Hunold ◽

Martin Grossherr ◽

...

Keyword(s):

Atrial Fibrillation ◽

Pulmonary Vein ◽

Pulmonary Vein Isolation ◽

Invasive Treatment ◽

Non Invasive

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

Innovations Technology and Techniques in Cardiothoracic and Vascular Surgery ◽

10.1097/01.imi.0000235467.09577.65 ◽

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.

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