Thrombus formation on the device is not uncommon in patients with AF who are treated by LAA closure. Such events are strongly associated with a higher risk of ischemic stroke during follow-up. (REgistry on Real-Life EXperience With Left Atrial Appendage Occlusion [RELEXAO]; NCT03279406).
Aims
The aim of this study was to compare procedural efficacy and safety, including 1-year freedom from AF recurrence, between the novel cryoballoon system PolarX (Boston Scientific) and the Arctic Front Advance Pro (AFA-Pro) (Medtronic), in patients with paroxysmal AF undergoing PVI.
Methods and results
This multicentre prospective observational study included 267 consecutive patients undergoing a first cryoablation procedure for paroxysmal AF (137 PolarX, 130 AFA-Pro). KM curves with the log-rank test was used to compare the 1-year freedom from AF recurrence between both groups. Multivariate Cox model was performed to evaluate whether the type of procedure (PolarX vs. AFA-Pro) had an impact on the occurrence of AF recurrences after adjustment on potentially confounding factors. The PolarX reaches lower temperatures than the AFA-Pro (LSPV 52 ± 5, vs. 59 ± 6; LIPV 49 ± 6 vs. 56 ± 6; right superior pulmonary vein: 49 ± 6 vs. 57 ± 7; right inferior pulmonary vein: 52 ± 6 vs. 59 ± 6; P < 0.0001). A higher rate of transient phrenic nerve palsy was found in patients treated with the PolarX system (15% vs. 7%, P = 0.05). After a mean follow-up of 15 ± 5 months, 20 patients (15%) had recurrences in AFA-Pro group and 27 patients (19%) in PolarX group (P = 0.35). Based on survival analysis, no significant difference was observed between both groups with a 12-month free of recurrence survival of 91.2% (85.1–95.4%) vs. 83.7% (76.0%–89.1%) (log-rank test P = 0.11). In multivariate Cox model hazard ratio of recurrence for PolarX vs. AFA-Pro was not significant [HR = 1.6 (0.9–2.8), P = 0.12].
Conclusion
PolarX and AFA-Pro have comparable efficacy and safety profiles for pulmonary veins isolation in paroxysmal atrial fibrillation.
Background-Some operators routinely extract chronically implanted transvenous leads from a femoral, whereas others prefer a superior approach. This prospective study compared the safety and effectiveness of laser sheaths versus femoral snare extractions. Methods and Results-The single-center study comprised 101 patients referred for unequivocal indications to extract Ն1 transvenous lead(s). Patients were Ͼ4 years of age and were randomly assigned to extractions with a laser sheath (group 1: nϭ50) versus a snare via femoral approach (group 2: nϭ51). The multicenter study comprised 358 patients who underwent extraction of old transvenous leads using laser sheaths (nϭ218, group 3) in 3 centers and from a femoral approach (nϭ138, group 4) in 3 other centers. In the single-center study, the success and complications rates were similar in groups 1 and 2. No patient died of a periprocedural complication. The procedural duration (51Ϯ22 versus 86Ϯ51 minutes) and duration of total fluoroscopic exposure (7Ϯ7 versus 21Ϯ17 minutes) were significantly shorter (each PϽ0.01) in group I than in group 2. In the multicenter study, we observed 2 procedure-associated deaths in group 3 versus 1 in group 4. Major procedural complications were observed in 3% of patients in group 3, versus 3% in group 4 (PϭNS). The rates of complete, partial, and unsuccessful extractions were similar in groups 3 and 4. Conclusions-Old transvenous leads were extracted with similar success and complication rates by the femoral and laser approaches. However, the femoral approach was associated with longer procedures and a longer duration of fluoroscopic exposure. (Circ Arrhythm Electrophysiol. 2010;3:319-323.)
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.
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