Safety and efficacy of multipolar pulmonary vein ablation catheter vs. irrigated radiofrequency ablation for paroxysmal atrial fibrillation: a randomized multicentre trial.
ABSTRACT: The current challenge in atrial fibrillation (AF) treatment is to develop effective, efficient, and safe ablation strategies. This randomized controlled trial assesses the medium-term efficacy of duty-cycled radiofrequency ablation via the circular pulmonary vein ablation catheter (PVAC) vs. conventional electro-anatomically guided wide-area circumferential ablation (WACA).One hundred and eighty-eight patients (mean age 62 ± 12 years, 116 M : 72 F) with paroxysmal AF were prospectively randomized to PVAC or WACA strategies and sequentially followed for 12 months. The primary endpoint was freedom from symptomatic or documented >30 s AF off medications for 7 days at 12 months post-procedure. One hundred and eighty-three patients completed 12 m follow-up. Ninety-four patients underwent PVAC PV isolation with 372 of 376 pulmonary veins (PVs) successfully isolated and all PVs isolated in 92 WACA patients. Three WACA and no PVAC patients developed tamponade. Fifty-six percent of WACA and 60% of PVAC patients were free of AF at 12 months post-procedure (P = ns) with a significant attrition rate from 77 to 78%, respectively, at 6 months. The mean procedure (140 ± 43 vs. 167 ± 42 min, P<0.0001), fluoroscopy (35 ± 16 vs. 42 ± 20 min, P<0.05) times were significantly shorter for PVAC than for WACA. Two patients developed strokes within 72 h of the procedure in the PVAC group, one possibly related directly to PVAC ablation in a high-risk patient and none in the WACA group (P = ns). Two of the 47 patients in the PVAC group who underwent repeat ablation had sub-clinical mild PV stenoses of 25-50% and 1 WACA patient developed delayed severe PV stenosis requiring venoplasty.The pulmonary vein ablation catheter is equivalent in efficacy to WACA with reduced procedural and fluoroscopy times. However, there is a risk of thrombo-embolic and pulmonary stenosis complications which needs to be addressed and prospectively monitored.NCT00678340.
Project description:Background:Pulmonary vein isolation (PVI) with multielectrode duty-cycled radiofrequency (PVAC) has been shown to be effective in the treatment of atrial fibrillation (AF). We describe pulmonary vein (PV) reconnection at repeat ablation in patients with AF recurrence after PVAC PVI and analyze the correlation between the time of AF recurrence and the observed PV reconnection patterns. Methods:Eighty-five patients undergoing a redo PVI for recurrent AF 9.2 ± 3.8 months after an initial PVAC PVI procedure was retrospectively enrolled. Results:A total of 93% had PV reconnections with a mean of 2.97 ± 1.2 reconnected PVs/patients and 75% of formerly isolated PVs were found reconnected. The highest reconnection rates (94%) were observed for left common trunks (CTs). A total of 33% patients had three and four reconnected PVs, respectively, while 7% were without PV reconnection. There was a moderate but significant negative correlation between the time of AF recurrences and the extending of PV reconnections at redo PVI for patients with proven PV reconnection (r = -0.32, P = 0.005), whereas five out of six patients without PV reconnection had recurrences within the first 9 months after PVI. Conclusions:At redo ablation most patients with recurrence of AF after PVAC PVI had PV reconnection(s). Patients with PV reconnection(s) showed a moderate negative correlation between the number of reconnected PVs and the time of AF recurrence with more extensive PV reconnections resulting in earlier PV recurrences after the blanking period. Patients without PV reconnection experienced early AF recurrences, indicating non-PV triggers contribute to AF recurrences in these patients.
Project description:Cryoballoon (CB) ablation is successful in eliminating atrial fibrillation (AF).The purpose of this study was to assess procedural efficacy and safety of CB ablation performed by a newly trained operator.Forty patients with documented paroxysmal AF (58 ± 11 years, 26 male) undergoing CB catheter ablation were prospectively enrolled.Electrical pulmonary vein (PV) isolation was achieved in all patients (156 PVs). The primary end point (PV isolation using CB only) was reached in 31 patients (92% PV isolation, 144/156 PVs). In the remaining 9 patients (12 PVs), additional single point cryofocal ablations were required to achieve isolation of all veins (LSPV, n = 5; LIPV, n = 3; LCPV, n = 2; RSPV, n = 1; RIPV, n = 1). There was no vascular access complication, pericardial effusion/tamponade, stroke/transient ischemic attack, phrenic nerve palsy, acute PV stenosis, or atrioesophageal fistula. The procedure duration decreased with experience by 30% from 155 min during the first 10 procedures to 108 min (final 10 treatments). Similar effects were observed with fluoroscopy time (-57%; from 28 min to 12 min), dose area product (-66%; from 22 Gy x cm2 to 8 Gy x cm2), CB time in the left atrium (-24%; from 99 min to 75 min), and cryoenergy delivery time (-19%; from 83 min to 67 min), when comparing cases #1-10 to cases #30-40.CB ablation of AF is effective and safe in the hands of a new operator. Procedure and fluoroscopy times decrease with user experience.
Project description:We hypothesized that pulmonary vein (PV) orientation influences tissue contact of the contact force (CF) sensing radiofrequency ablation catheter (CFC) and therefore atrial fibrillation (AF) free survival after pulmonary vein isolation (PVI). The aim of this study was to determine the association between PV orientation, CF and AF free survival in patients undergoing CFC PVI.Sixty consecutive patients undergoing CFC PVI were included. ECG-triggered cardiac CT scans were obtained in all patients before PVI, and the PV orientation was measured at the insertion in the LA for all PVs in both the transverse and frontal plane. PVs were assigned to 1 of 4 orientation groups: ventral-caudal, dorsal-caudal, ventral-cranial and dorsal-cranial.Mean age was 59 years, 88% had paroxysmal AF. AF free survival off anti-arrhythmic drugs after a median follow-up of 12 months was 58% after a single PVI procedure. No association was found between PV orientation and CF. Furthermore, no association was found between PV orientation and AF free survival. In univariate analysis, the number of lesions with a mean CF of 10 g was associated with AF free survival. However, in multivariate analysis, only the AF duration was significantly associated with AF free survival.This study shows that in patients undergoing PVI with the CFC ablation system, PV orientation does not affect CF and is not associated with AF free survival. PV orientation assessment does not appear to be necessary in patients undergoing CFC PVI.
Project description:Pulmonary vein reconnection after pulmonary vein isolation (PVI) is a significant problem in the treatment of paroxysmal atrial fibrillation (AF). We report about patients who underwent contact force (CF) guided PVI using CF catheter and compared them to patients with PVI using an ablation catheter with enhanced tip irrigation.A total of 59 patients were included in the analysis. In 30 patients circumferential PVI was performed using the Thermocool Smarttouch(®) ablation catheter (ST) whereas in 29 patients circumferential PVI using the Thermocool Surround Flow SF(®) ablation catheter (SF) was performed. Patients were compared in regard to procedure time, fluoroscopy time/dose as well as RF-application duration and completeness of PVI. Adverse events (pericardial effusion, PV stenosis, stroke, death) were evaluated. The presence of sinus rhythm off antiarrhythmic medication was assessed during 6 months follow-up using multiple 7 day Holter-ECGs.In both groups, all PVs were isolated without serious adverse events. Procedure time was 2.15 ± 0.5 h (ST) vs. 2.37 ± 1.13 h (SF) (p = 0.19). Duration of RF-applications was 46.6 ± 18 min (ST) and 49.8 ± 19 min (SF) (p = 0.52). Fluoroscopy time was 25.2 ± 13 min (ST) vs. 29 ± 18 min (SF), fluoroscopy dose 2675.6 ± 1658 versus 3038.3 ± 1997 cGym(2) (p = 0.36 and 0.46 respectively). Sinus rhythm off antiarrhythmic medication validated with 7 day Holter ECGs was present in both groups in 72% of patients after 6 months of follow up.PVI using the new contact force catheter is safe and effective in patients with paroxysmal AF.
Project description:BACKGROUND:Ablation procedures in patients with paroxysmal atrial fibrillation (PAF) includes isolation of all pulmonary veins (PVs). We hypothesized that an approach using an algorithm to detect arrhythmogenic PVs (aPVs) might lead to shorter procedure duration (PD) and fewer proarrhythmic effects (PE). HYPOTHESIS:Isolation of the aPVs only leads to a reduced PD, reduced PEs, and fewer adverse events, with a success rate comparable to the standard all-PV approach. METHODS:In this prospective trial, 207 patients with PAF were randomized to undergo isolation of the aPV (AG group, n?=?105) or isolation of all PVs (VG group, n?=?102). The aPV was identified by atrial fibrillation (AF) induction, focal discharge, or short local PV decremental conduction during PV pacing. Patients were followed with repetitive 7-day Holter electrocardiograms (ECGs) after 3, 6, and 12?months in our arrhythmia clinic. RESULTS:In 97% of patients, at least 1 aPV was identified (mean, 2.1). PD did not differ significantly (152.3?±?57.1?minutes vs 162?±?68?minutes, P = 0.27) between the groups, but the number of radiofrequency (RF) applications and fluoroscopy time (FT) and dose were significantly lower in the AG group than in the VG group. The occurrence of PE (new-onset atrial tachycardia) and adverse events (AE) did not differ between the 2 groups (P = 0.1). Sinus rhythm off antiarrhythmic medication (documented on 7-day Holter ECGs) 12?months after a single procedure was achieved in 53% in the AG group and 59% in the VG group (P = 0.51). CONCLUSIONS:Isolation of the aPVs detected by a straightforward algorithm leads to similar success rates compared to a standard all-PV approach with regard to PD, AE, or PE and is associated with less RF and a shorter FT.
Project description:This multicentre, randomized trial compared three strategies of AF ablation: ablation of complex fractionated electrograms (CFE) alone, pulmonary vein isolation (PVI) alone, and combined PVI + CFE ablation, using standardized automated mapping software.Patients with drug-refractory, high-burden paroxysmal (episodes >6 h, >4 in 6 months) or persistent atrial fibrillation (AF) were enrolled at eight centres. Patients (n = 100) were randomized to one of three arms. For CFE alone (n = 34), spontaneous/induced AF was mapped using validated, automated CFE software and all sites <120 ms were ablated until AF termination/non-inducibility. For PVI (n = 32), all four PV antra were isolated and confirmed using a circular catheter. For PVI + CFE (n = 34), all four PV antra were isolated, followed by AF induction and ablation of all CFE sites until AF termination/non-inducibility. Patients were followed at 3, 6, and 12 months with a visit, ECG, 48 h Holter. Atrial fibrillation symptoms were confirmed by loop recording. Repeat procedures were allowed within the first 6 months. The primary endpoint was freedom from AF >30 s at 1 year. Patients (age 57 +/- 10 years, LA size 42 +/- 6 mm) were 35% persistent AF. In CFE, ablation terminated AF in 68%. Only 0.4 PVs per patient were isolated as a result of CFE. In PVI, 94% had all four PVs successfully isolated. In PVI + CFE, 94% had all four PVs isolated, 76% had inducible AF with additional CFE ablation, with 73% termination of AF. There were significantly more repeat procedures in the CFE arm (47%) vs. PVI (31%) or PVI + CFE (15%) (P = 0.01). After one procedure, PVI + CFE had a significantly higher freedom from AF (74%) compared with PVI (48%) and CFE (29%) (P = 0.004). After two procedures, PVI + CFE still had the highest success (88%) compared with PVI (68%) and CFE (38%) (P = 0.001). Ninety-six percent of these patients were off anti-arrhythmics. Complications were two tamponades, no PV stenosis, and no mortality.In high-burden paroxysmal/persistent AF, PVI + CFE has the highest freedom from AF vs. PVI or CFE alone after one or two procedures. Complex fractionated electrogram alone has the lowest one and two procedure success rates with a higher incidence of repeat procedures. ClinicalTrials.gov identifier number NCT00367757.
Project description:Introduction:Long term prospective data comparing the efficacy of radiofrequency (RF) and cryoballoon ablation (CRYO) for paroxysmal atrial fibrillation (PAF) is lacking. We report the long-term outcomes of a randomized control trial comparing CRYO to RF ablation, or a novel COMBINED approach (RF followed by CRYO) for PAF. We studied the number and pattern of pulmonary vein (PV) reconnections in patients undergoing repeat procedure(s). The COMBINED approach had significantly higher single procedure success rate and is associated with the fewest reconnected PVs. Methods:203 patients who underwent first time PAF ablation in a randomized clinical trial comparing CRYO (67), RF (67) and COMBINED (69) approaches were followed up. All patients with symptomatic recurrence of AF were offered a repeat procedure(s). Reconnected PV(s) at repeat procedure(s) were recorded. In a subset, the PV reconnection sites during the first repeat procedure were prospectively assessed and categorised into one of 8 segments. . Results:At 5 years, 57% of COMBINED patients remained free of AF after a single procedure compared to 47% CRYO and 19% RF patients (p<0.001 COMBINED vs RF and CRYO vs RF, p=0.043 COMBINED vs CRYO). During the first repeat procedure, theCOMBINED group had less number of reconnected PVs (mean number of reconnected PVs in the COMBINED group 1.2 vs 2.3 CRYO and 2.4 RF, p=0.034). There was a different pattern of PV reconnection comparing the CRYO and RF groups. Conclusion:The COMBINED approach had a significantly higher single procedure success rate with fewer reconnected PVs and fewer reconnection sites compared to either CRYO or RF alone. CRYO in turn was superior to RF. PV reconnection pattern differed between CRYO and RF and the synergistic effect of the COMBINED approach may explain the improved single procedure efficacy.
Project description:INTRODUCTION:Visually guided laser balloon (VGLB) ablation is unique in that the operator delivers ablative energy under direct visual guidance. In this multicenter study, we sought to determine the feasibility, efficacy, and safety of performing pulmonary vein isolation (PVI) using this VGLB. METHODS:Patients with symptomatic, drug-refractory paroxysmal atrial fibrillation (AF) underwent PVI using the VGLB with the majority of operators conducting their first-ever clinical VGLB cases. The primary effectiveness endpoint was defined as freedom from treatment failure that included: Occurrence of symptomatic AF episodes ?1 minutes beyond the 90-day blanking, the inability to isolate 1 superior and 2 total PVs, occurrence of left atrial flutter or atrial tachycardia, or left atrial ablation/surgery during follow-up. RESULTS:A total of 86 patients (mean age 56 ± 10 years, 67% male) were treated with the VGLB at 10 US centers. Mean fluoroscopy, ablation, and procedure times were 39.8 ± 24.3 minutes, 205.2 ± 61.7 minutes, and 253.5 ± 71.3 minutes, respectively. Acute PVI was achieved in 314/323 (97.2%) of targeted PVs. Of 84 patients completing follow-up, the primary effectiveness endpoint was achieved in 50 (60%) patients. Freedom from symptomatic or asymptomatic AF was 61%. The primary adverse event rate was 16.3% (8.1% pericarditis, phrenic nerve injury 5.8%, and cardiac tamponade 3.5%). There were no cerebrovascular events, atrioesophageal fistulas, or significant PV stenosis. CONCLUSIONS:This multicenter study of operators in the early stage of the learning curve demonstrates that PVI can be achieved with the VGLB with a reasonable safety profile and an efficacy similar to radiofrequency ablation.
Project description:Pulmonary vein isolation (PVI) for atrial fibrillation (AF) is performed with the endoscopically assisted laser balloon ablation system (EAS). We hypothesized that placement of a circular mapping catheter (CMC) in the pulmonary vein (PV) distal to the laser balloon during ablation is feasible and safe.Out of 58 included patients, 37 underwent mapping-guided EAS PVI, with the CMC inside the PV during laser ablation, and 21 patients underwent standard EAS PVI, with the CMC outside the PV during laser ablation.Mean age was 56 years and 81% had paroxysmal AF. In the mapping-guided ablation group, 91% of PVs were isolated with the CMC in the PV during EAS ablation, isolation was completed in 9% of PVs after the CMC was removed from the PV. After passing a learning curve in 18 patients, a significant drop in unsuccessfully isolated PVs was observed in the mapping guided EAS PVI group (15% to 4%, P = 0.020). No major complications were seen in the mapping-guided EAS PVI group. However, in the standard EAS PVI group, laser ablation was complicated by a temporary phrenic nerve palsy in 1 patient. After a median follow-up of 16.7 months, there was no statistical difference in AF free survival among treatment groups (mapping-guided: 56% vs. 52%, P = 0.875).Mapping guided EAS PVI with a distal CMC in the PV during laser ablation is feasible and seems safe as the standard EAS PVI approach.
Project description:BACKGROUND:Massive hemoptysis is a life-threatening condition. Massive hemoptysis caused by pulmonary vein stenosis (PVS) after radiofrequency catheter ablation for atrial fibrillation (AF) is rare. However, bilateral lung hemorrhage following bilateral PVS is extremely rare. CASE PRESENTATION:We herein describe a 62-year-old man with refractory massive hemoptysis after radiofrequency catheter ablation for AF, which was successfully controlled by surgical lobectomy and endovascular bilateral PV stenting. The hemorrhage was derived from the bilateral lungs following PV obstruction and bilateral PVS, which was definitively diagnosed by bronchoscopic examination. The patient had no recurrence of hemoptysis during a follow-up period of 30 months, and the PV stents had not narrowed as shown by computed tomography 30 months after stent placement. CONCLUSIONS:Massive hemoptysis can be caused by bilateral PVS after radiofrequency catheter ablation for AF, and hemorrhage from the bilateral lungs in such patients is extremely rare. Nevertheless, cardiologists, interventional radiologists, and pulmonologists should consider the potential for massive hemoptysis caused by PVS.