Aims
To evaluate the effectiveness and safety of cryoballoon ablation (CBA) compared with radiofrequency ablation (RFA) for symptomatic paroxysmal or drug-refractory persistent atrial fibrillation (AF).
Methods and results
Prospective cluster cohort study in experienced CBA and RFA centres. Primary endpoint was ‘atrial arrhythmia recurrence’, secondary endpoints were as follows: procedural results, safety, and clinical course. A total of 4189 patients were included: CBA 2329 (55.6%) and RFA 1860 (44.4%). Cryoballoon ablation population was younger, with fewer comorbidities. Procedure time was longer in the RFA group (P = 0.01). Radiation exposure was 2487 (CBA) and 1792 cGycm2 (RFA) (P < 0.001). Follow-up duration was 441 (CBA) and 511 days (RFA) (P < 0.0001). Primary endpoint occurred in 30.7% (CBA) and 39.4% patients (RFA) [adjusted hazard ratio (adjHR) 0.85, 95% confidence interval (CI) 0.70–1.04; P = 0.12). In paroxysmal AF, CBA resulted in a lower risk of recurrence (adjHR 0.80, 95% CI 0.64–0.99; P = 0.047). In persistent AF, the primary outcome was not different between groups. Major adverse cardiovascular and cerebrovascular event rates were 1.0% (CBA) and 2.8% (RFA) (adjHR 0.53, 95% CI 0.26–1.10; P = 0.088). Re-ablations (adjHR 0.46, 95% CI 0.34–0.61; P < 0.0001) and adverse events during follow-up (adjHR 0.64, 95% CI 0.48–0.88; P = 0.005) were less common after CBA. Higher rehospitalization rates with RFA were caused by re-ablations.
Conclusions
The primary endpoint did not differ between CBA and RFA. Cryoballoon ablation was completed rapidly; the radiation exposure was greater. Rehospitalization due to re-ablations and adverse events during follow-up were observed significantly less frequently after CBA than after RFA. Subgroup analysis suggested a lower risk of recurrence after CBA in paroxysmal AF.
Trial Registration
ClinicalTrials.gov (NCT01360008), https://clinicaltrials.gov/ct2/show/NCT01360008.
RF ablation is the most widespread ablation method in Germany, but use of cryoballoon increased significantly. Procedure times were similar, but ablation and fluoroscopy times were longer in cryoballoon ablation. No significant differences were found in terms of acute success and overall complication rate.
The success and safety of standard catheter radiofrequency ablation may be limited for ablation of atrial fibrillation and ventricular tachycardia. The aim of this study was to characterize and compare different cooled and noncooled catheter systems in terms of their specific lesion geometry, incidence of impedance rise, and crater and coagulum formation to facilitate appropriate catheter selection for special indications. The study investigated myocardial lesion generation of three cooled catheter systems (7 Fr, 4-mm tip): two saline irrigation catheters with a showerhead-type electrode tip (sprinkler) and a porous metal tip and an internally cooled catheter. Noncooled catheters (7 Fr) had a large tip electrode (8 mm) and a standard tip electrode (4 mm). RF energy was delivered on isolated porcine myocardium superfused with heparinized pig blood (37 degrees C) at power settings of 10-40 W. Both irrigated systems were characterized by a large lesion depth (8.1 +/- 1.6 mm) and a large lesion diameter (13.8 +/- 1.6 mm). In comparison, internally cooled lesions showed a similar lesion depth (8.0 +/- 1.0 mm), but a significantly smaller lesion diameter (12.3 +/- 1.2 mm,P = 0.04). Large tip lesions had a similar lesion diameter (14.5 +/- 1.6 mm), but a significantly smaller lesion depth (6.3 +/- 1.0 mm,P = 0.002) compared to irrigated lesions. However, lesion volume was not significantly different between the three cooled and the large tip catheter. To induce maximum lesion size, power requirements were three times higher for the irrigation systems and two times higher for the internally cooled and the large tip catheter compared to the standard catheter. Impedance rise was rarest with irrigated and large tip ablation. In case of impedance rise crater formation was a frequent observation (61-93%). Irrigated catheters prevented coagulum formation most effectively. Irrigated rather than internally cooled ablation appears to be most adequate for the induction of deep and long lesions at a low rate of impedance rise and thrombus formation. Large tip ablation may be feasible for the creation of long linear lesions, however, with an increased risk of thrombus formation.
Transvenous polyurethane ICD leads showed a high rate of lead insulation failure late after implantation with frequent inappropriate shock deliveries. Close follow-up is mandatory in patients with these leads. Automated device control features with patient alert function integrated into new devices may contribute to early detection of lead failure.
Arrhythmogenic right ventricular dysplasia is a structural heart disease characterized by fibrofatty degeneration of right ventricular myocardium and arrhythmias of right ventricular origin. The aim of this study was to characterize endocardial right ventricular activation by electroanatomic mapping as a guide for catheter ablation in patients with arrhythmogenic right ventricular dysplasia. Electroanatomic mapping and entrainment procedures were performed in 5 patients with arrhythmogenic right ventricular dysplasia. Endocardial mapping during ventricular tachycardia demonstrated a focal activation pattern with radial spreading of activation from a site of earliest ventricular activation in all directions. Right ventricular activation time (127 +/- 34 ms) was markedly shorter than tachycardia cycle length (415 +/- 92 ms). The site of earliest ventricular activation was found in an aneurysmal outflow tract (n = 2), at the border of aneurysms near the tricuspid annulus (n = 2), and at the apex of the right ventricle (n = 1). Entrainment mapping criteria of these areas of earliest endocardial activity were consistent with exit sites of a reentrant circuit in an area of abnormal myocardium. Fractionated potentials were found 61 +/- 29 ms before the onset of the QRS complex at these sites. Catheter ablation rendered the "clinical" ventricular tachycardia noninducible in four patients but "nonclinical" faster ventricular tachycardias were inducible in three patients. During the follow-up of 7 +/- 3 months after ablation, the frequency of therapies in 4 patients with an implantable cardioverter defibrillator decreased from 49 +/- 61 episodes per month before ablation, to 0.3 +/- 0.5 episodes per month after ablation (P < 0.05). Electroanatomic mapping during ventricular tachycardia facilitates localization of exit sites in relation to aneurysms in diseased right ventricle and may guide catheter ablation in patients with arrhythmogenic right ventricular dysplasia.
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