Safety Of Pulmonary Vein Isolation Research Articles

Efficacy and safety of pulmonary veins isolation by cryoablation for the treatment of paroxysmal and persistent atrial fibrillation

We examined the efficacy and safety of pulmonary vein (PV) isolation, using a cryoballoon catheter. We studied 117 consecutive patients presenting with paroxysmal (n = 92) or persistent (n = 25) atrial fibrillation (AF), who underwent attempts at isolation of 442 PV with a cryoballoon catheter. They were followed in our ambulatory department for every 3 months, or earlier if they reported symptoms. A 48 h ambulatory electrocardiogram was recorded at the 3-month visit. We analysed the immediate and long-term procedural and clinical outcomes. We isolated 385 of 442 PV (87%) with a single cryoballoon application. In 19 patients (16%), an irrigated-tip radiofrequency (RF) catheter was used to create a supplemental focal lesion. A median of nine applications per procedure (range 6-12) was delivered. The mean, overall procedural duration was 155 ± 43 min (range 75-275), and mean duration of fluoroscopic exposure was 35 ± 15 min (range 12-73). At the end of the procedure, 103 patients (88%) were in sinus rhythm. Over a median period of 9.6 months (range 3-12), 11 patients were lost to follow-up. At 3, 6, 9, and 12 months of follow-up, respectively, 79, 79, 79, and 69% of patients presenting with paroxysmal AF had remained recurrence free, vs. 83, 73, 59, and 45% of patients, respectively, with persistent AF. Phrenic nerve palsy was the most frequent, although reversible complication. Pulmonary vein isolation, using a cryoballoon catheter, was completed with a high rate of procedural and long-term success and low rate of minor complications. Supplemented, when needed, by focal RF, cryoballoon ablation was a safe and an effective alternative to a circumferential RF procedure.

201 Pulmonary vein isolation by cryoballoon ablation in patients with paroxysmal atrial fibrillation: efficacy, safety and predictors of arrhythmia recurrence

Radiofrequency (RF) catheter ablation has emerged as an effective treatment for patients with drug-refractory atrial fibrillation (AF). The objective of this study is to evaluate the efficacy and safety of pulmonary vein isolation (PVI) with a cryoballoon catheter (Arctic Front, Cryocath, Quebec, Canada). In 44 consecutive patients with symptomatic paroxysmal AF (28 males, age 57 +/− 11 years), circumferential PVI was performed using a cryoballoon catheter. Before discharge, all patients were subjected to 24-hour Holter electrocardiograms, echocardiography, and esophageal endoscopy. Magnetic resonance imaging was performed prior to and 3 months after ablation. At a mean follow up of 4.3 +/− 1.2 months after ablation, patients underwent clinical review and 24-hour Holter electrocardiograms. Clinical and demographic variables were analyzed via logistic regression to assess for predictors of recurrence. Thirty-two of the 44 patients (73%) had complete isolation of all PVs. Out of 176 treated veins, 164 were completely isolated (93%). The number of balloon applications per vein was 2.3 ± 0.8. The mean procedure and fluoroscopy times were 163.4 ± 36.2 and 32.0 ± 11.7 min, respectively. Eight patients had evidence of mild pericardial effusions requiring no further treatment. Five patients (11.4%) experienced phrenic nerve palsy, 4 of which resolved immediately and one at 2 weeks. Follow up at 4.3 +/− 1.2 months showed freedom from AF in 28 patients (63.6%) and freedom from AF without antiarrhythmic drug therapy in 19 patients (43.2%). Of all clinical variables analyzed, only early recurrence of AF within 4 days post ablation was associated with long term AF recurrence (p = 0.002; OR = 0.11; CI = [0.018–0.524]). PVI can be safely achieved with the cryoballoon catheter with a moderate success rate at 4.3 months follow-up. Early recurrence of AF seems to be a clinical predictor for long term atrial fibrillation recurrence.

Pulmonary Vein Isolation for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation

Background— Catheter ablation is an established yet evolving nonpharmacologic intervention for the maintenance of sinus rhythm in patients with atrial fibrillation (AF). The efficacy and safety of pulmonary vein isolation (PVI) compared with medical therapy remain in question. Methods and Results— We conducted a meta-analysis of all randomized, controlled trials comparing PVI and medical therapy for the maintenance of sinus rhythm. The primary end point in this analysis was freedom from recurrent AF at 12 months. The relative efficacy of PVI was estimated using random-effects modeling according to intention to treat. We identified 6 trials that randomized a total of 693 patients with AF to PVI or control. PVI was associated with markedly increased odds of freedom from AF at 12 months of follow-up (n=266/344 [77%] versus n=102/346 [29%]; odds ratio, 9.74; 95% CI, 3.98 to 23.87). When we excluded the trial that only enrolled patients with persistent AF (Q-statistic, 2.485; P =0.647 after exclusion), PVI was associated with even greater odds of AF-free survival (15.78; 95% CI, 10.07 to 24.73). PVI was associated with a decreased hospitalization for cardiovascular causes (14 versus 93 per 100 person-years; rate ratio, 0.15; 95% CI, 0.10 to 0.23). Among those randomly assigned to PVI, 17% required a repeat PVI ablation before 12 months. The rate of major complications was 2.6% (n=9/344) in the catheter ablation group. Conclusions— Compared with a nonablation treatment strategy, PVI results in dramatically increased freedom from AF at 1 year. Although the procedure can be associated with major complications, the risk of these complications is comparable to other interventional procedures.

Radiofrequency ablation of atrial fibrillation under therapeutic international normalized ratio: A safe and efficacious periprocedural anticoagulation strategy

The best periprocedural anticoagulation strategy at the time of pulmonary vein isolation (PVI) is not known. Most centers stop administering warfarin (Coumadin) and use bridging with heparin or enoxaparin. The purpose of this study was to evaluate the efficacy and safety of PVI under therapeutic international normalized ratio (INR). Between January 2005 and December 2008, PVI was performed in 3,052 patients with therapeutic INR (> or =1.8) at the time of ablation. All patients were evaluated for ischemic strokes and bleeding complications. Mean INR was 2.53 +/- 0.62. Only 3 (0.098%) patients had ischemic strokes. One patient had a hemorrhagic stroke on the third day postablation but recovered completely by 1-week follow-up. Bleeding complications occurred in 34 (1.11%) patients; most were minor (0.79%). Major hemorrhagic complications occurred in 10 (0.33%) patients (tamponade in 5, hematomas requiring intervention in 2, transfusion necessary in 3). In a large patient population, continuation of Coumadin at a therapeutic INR at the time of PVI without use of heparin or enoxaparin for bridging is a safe and efficacious periprocedural anticoagulation strategy. It is an acceptable and potentially better alternative to strategies that use bridging with heparin or enoxaparin.

A08-4 Efficacy and safety of pulmonary vein isolation using cryo-thermal energy. initial results

A08-4 Efficacy and safety of pulmonary vein isolation using cryo-thermal energy. initial results

A08-5 Feasibility and safety of pulmonary vein isolation using a new mapping and ablation system in patients with refractory atrial fibrillation

A08-5 Feasibility and safety of pulmonary vein isolation using a new mapping and ablation system in patients with refractory atrial fibrillation

A08-4 Efficacy and safety of pulmonary vein isolation using cryo-thermal energy. initial results

A08-4 Efficacy and safety of pulmonary vein isolation using cryo-thermal energy. initial results

A08-5 Feasibility and safety of pulmonary vein isolation using a new mapping and ablation system in patients with refractory atrial fibrillation

A08-5 Feasibility and safety of pulmonary vein isolation using a new mapping and ablation system in patients with refractory atrial fibrillation

Feasibility and Safety of Pulmonary Vein Isolation Using a New Mapping and Navigation System in Patients With Refractory Atrial Fibrillation

Ostial pulmonary vein (PV) isolation by radiofrequency (RF) catheter ablation can cure patients with atrial fibrillation (AF); however, this procedure carries the risk of PV stenosis. The aim of this study was to assess the feasibility of a new mapping and navigation technique using a multipolar basket catheter (BC) for PV isolation in patients with refractory AF and to analyze its safety with regard to PV stenosis at long-term follow-up. We studied 55 patients (mean age, 53+/-11 years; 40 male) with drug-refractory AF (paroxysmal, n=37; persistent, n=18). A 64-pole BC was placed transseptally into each of the accessible PVs. By use of a nonfluoroscopic navigation system, the ablation catheter was guided to the BC electrodes at the PV ostium, with earliest activation during sinus rhythm. RF was delivered by use of maximum settings of temperature at 50 degrees C and power at 30 W. The end point of the procedure was the complete elimination of all distal and fragmented ostial PV potentials. Of 165 targeted veins, 163 were successfully isolated with a mean RF duration of 720+/-301 seconds per vein. At 1-year follow-up, 62% of the patients were in sinus rhythm without antiarrhythmic drugs. Contrast-enhanced magnetic resonance angiography revealed 2 PV stenoses of >25% out of 165 treated vessels. The use of a multipolar BC allowed effective and safe PV isolation by combining 3D mapping and navigation. At 1-year follow-up, 62% of the patients were in sinus rhythm without antiarrhythmic drugs, and the incidence of relevant diameter reduction of the treated PVs was 1.2%.