Long-term outcomes of cryoballoon pulmonary vein isolation for paroxysmal and persistent atrial fibrillation in Chinese patients.

PURPOSE: We aimed to study the long-term outcomes of cryoballoon (CB) pulmonary vein isolation (PVI) in treating Chinese patients with atrial fibrillation (AF). METHODS: A total of 122 patients (48 women, mean age 57.4 ± 11.3) underwent CB PVI (first generation CB 44.3%, second generation CB 55.7%) for AF (paroxysmal 65.6%, persistent 10.7% and long-standing persistent 23.8%). RESULTS: PVI was achieved in 113 (92.6%) patients with CB alone, and it was achieved in all patients with additional touch-up by 8-mm-tip cryocatheter. The mean procedural and fluoroscopic duration were 171.9 ± 41 and 46.6 ± 14.6 min respectively. The recurrence-free survival for paroxysmal and non-paroxysmal AF was 77% and 59% respectively at 1 year and progressively declined over time to reach a plateau of 52% and 30% for paroxysmal and non-paroxysmal AF respectively at 5 years. In patients undergoing PVI with second-generation CB, the recurrence-free survival was 75% for paroxysmal AF and 45% for non-paroxysmal AF at 5 years. With multivariate Cox regression analysis, the types of CB (use of second-generation CB: HR 0.49; 95% CI 0.28-0.85; p = 0.011) and size of left atrium (LA) (larger LA size: HR 1.52; 95% CI 1-2.14; p = 0.017) independently predicted recurrence. Transient phrenic nerve injury (PNI) occurred in four (3.3%) patients and persistent PNI occurred in four (3.3%) patients. Other complications occurred in 10 (8.2%) patients with no procedure-related death. CONCLUSIONS: Long-term success of CB PVI for AF declined over time and reached a plateau at 5 years. CB types and LA size are independent predictors for long-term recurrence.

A Very Long-term Longitudinal Study on the Evolution and Clinical Outcomes of Persistent Iatrogenic Atrial Septal Defect After Cryoballoon Ablation.

BACKGROUND: Persistent iatrogenic atrial septal defect (iASD) is a common but poorly characterized complication after cryoballoon (CB) pulmonary vein isolation (PVI) procedures. We therefore investigate its prevalence, evolution, risk factors, and clinical outcomes in a prospective longitudinal study. METHODS: A total of 108 patients (41 women, mean age 57 ± 11.3) underwent CB PVI for AF. Serial transesophageal echocardiography (TEE) was performed 9 months and then annually until 6 years after the procedure to study the characteristics of persistent iASD. RESULTS: Persistent iASD occurred in 33 (30.6%) patients 9 months after CB PVI. Spontaneous closure of iASD was found in 6 (22.2%) and 3 (15.8%) patients 2 and 3 years after the procedures, respectively. No spontaneous closure was observed on 4, 5, and 6-year TEE follow-up. The projected long-term persistence rate of iASD after CB PVI was therefore 20% (30.6% × 0.778 × 0.842). Using multivariate logistic regression, a higher number of cryoapplications (≥ 2 minutes) was the only independent predictor of persistent iASD 9 months after CB PVI (odds ratio [OR] 1.207; 95% confidence interval [CI], 1.033-1.411, P = 0.018). Two (1.9%) patients with significantly larger iASD size than the others (long diameter 12.6 ± 0.8 vs 3.7 ± 1.5 mm, P < 0.001; short diameter 10.9 ± 0.2 vs 3 ± 1.1 mm, P < 0.001) required percutaneous closure because of exertional dyspnea and right ventricular enlargement. Over 129.7 patient-years follow-up, during which iASD persisted, there was no occurrence of neurologic events. CONCLUSIONS: Approximately one fifth of patients undergoing CB PVI will have permanently persistent iASD. Patients with defect sizes of greater than 10 mm may need percutaneous closure due to significant left-to-right shunting.

Inner lumen mapping catheter-facilitated big cryoballoon treatment for atrial fibrillation shortens procedural duration and fluoroscopic exposure with comparable mid-term efficacy.

PURPOSE: This study aims to investigate whether the use of a novel inner lumen circular mapping catheter (IMC) can shorten the procedural duration and fluoroscopic exposure of the single transseptal big cryoballoon (CB) pulmonary vein isolation (PVI) procedures in patients with atrial fibrillation (AF). METHODS: This is a prospective non-randomized case-control study. Forty-two patients (28 men, mean age 55.7 ± 12.1) with drug-refractory paroxysmal or persistent AF and underwent CB PVI procedures were divided into Group A (conventional single transseptal big CB approach, n = 21) and Group B (IMC-facilitated approach, n = 21). They were compared in the co-primary endpoints: (1) procedural duration and (2) fluoroscopic exposure and secondary endpoints: (1) 6-month AF-free survival and (2) number of cryo-applications. RESULTS: Both the procedural duration (162 ± 26 vs. 215 ± 25 min; p < 0.001) and fluoroscopic exposure (44.1 ± 10.4 vs. 56.8 ± 11.7 min; p = 0.001) were significantly shorter in Group B than Group A patients. With multivariate stepwise regression, only the use of IMC was an independent predictor for procedural duration (ß = -59; 95 % CI, -84.1 to -33.8; p < 0.001) and fluoroscopic exposure (ß = -16.9; 95 % CI, -28.4 to -5.4; p = 0.006). The number of cryo-applications was significantly fewer in Group B than Group A patients (median 8 vs. 11; p = 0.001). There was no significant difference in the 6-month AF-free survival between the two approaches (57 % vs. 71 %; p = 0.351). CONCLUSIONS: Compared to conventional single transseptal big CB PVI procedures, the use of IMC may reduce procedural duration, fluoroscopic exposure and the number of cryo-applications with comparable mid-term efficacy.