Secondary prevention of cryptogenic stroke in patients with patent foramen ovale: a systematic review and meta-analysis

The aim of our study is to compare patent foramen ovale (PFO) closure versus medical treatment and antiplatelet versus anticoagulant therapy in patients with cryptogenic stroke (CS) and PFO. We conducted a systematic review and meta-analysis with trial sequential analysis (TSA) of randomized trials. Primary outcomes are stroke or transient ischemic attack (TIA) and all-cause mortality. Secondary outcomes are peripheral embolism, bleeding, serious adverse events, myocardial infarction and atrial dysrhythmias. We performed an intention to treat meta-analysis with a random-effects model. We include six trials (3677 patients, mean age 47.3 years, 55.8% men). PFO closure is associated with a lower recurrence of stroke or TIA at a mean follow-up of 3.88 years compared to medical therapy [risk ratio (RR) 0.55, 95% CI 0.38–0.81; I²?=?40%]. The TSA confirms this result. No difference is found in mortality (RR 0.74, 95% CI 0.35–1.60; I²?=?0%), while PFO closure is associated with a higher incidence of atrial dysrhythmias (RR 4.55, 95% CI 2.16–9.60; I²?=?25%). The rate of the other outcomes is not different among the two groups. The comparison between anticoagulant and antiplatelet therapy shows no difference in terms of stroke recurrence, mortality and bleeding. There is conclusive evidence that PFO closure reduces the recurrence of stroke or TIA in patients younger than 60 years of age with CS. More data are warranted to assess the consequences of the increase in atrial dysrhythmias and the advantage of PFO closure over anticoagulants.     

Initial experience of three-minute freeze cycles using the second-generation cryoballoon ablation: acute and short-term procedural outcomes

Background

The second-generation cryoballoon (CB-A) (Arctic Front Advance, Cryocath, Medtronic, MN, USA) might significantly improve procedural outcome with respect to the first-generation balloon. These technological improvements might also question the current recommendation of the need a 4-min freeze to achieve durable pulmonary vein isolation (PVI).

Objective

The main aim of the study was to analyze the procedural efficacy of a 3-min freeze–thaw cycles with the CB-A balloon in the terms of rates of acute PVI and 6-month outcome.

Methods

Patients having undergone CB-A for PAF or early persistent AF, with 3-min freeze–thaw cycles were consecutively included in our analysis. Acute procedural success was measured in terms of the rate of PVI. Short-term follow-up was evaluated by the means of 24-h Holters and clinical examinations at regular intervals.

Results

Fifty-two consecutive patients (35 male (67 %); mean age, 59.8?±?10.5) were included. Mean procedure and fluoroscopy times were 96?±?15 and 13.2?±?8.3 min, respectively. Mean time from groin puncture to catheter extraction was 60.4?±?20 min. After a mean of 1.5 freeze cycles per vein of 3 min in duration, all 208 (100 %) PVs could be isolated with the CB-A. A total 192 (91 %) veins were isolated during the first freeze. At a mean of 5.7-month follow-up, 82 % of patients were free of AF.

Conclusion

CB-A is effective in producing PVI by using 3-min-duration freeze cycles. After a mean of 1.5 freeze per vein, freedom from AF was achieved in 82 % of patients at 6-month follow-up.