Aims Whether pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF) using contact force (CF)-guided radiofrequency (RF) or second-generation cryoballoon (CB) present similar efficacy and safety remains uncertain. Methods and results We performed a multicentre study comparing procedural safety and arrhythmia recurrence after standardized PVI catheter ablation for PAF using CF-guided RF ablation (Thermocool® SmartTouch™, Biosense Webster; or Tacticath™, St Jude Medical) (CF group) with second-generation CB ablation (Arctic Front Advance™, Medtronic) (CB group). Overall, 376 patients (mean age 59.8 ± 10.4 years, 280 males) were enrolled in 4 centres: 198 in CF group and 178 in CB group. Procedure was shorter for CB group than for CF group (109.6 ± 40 vs. 122.5 ± 40.7 min, P = 0.003), but fluoroscopy duration and X-ray exposure were not statistically different ( P = 0.1 and P = 0.22, respectively). Overall complication rate was similar in both groups: 14 (7.1%) in the CF group vs. 13 (7.3%) in the CB group ( P = 0.93). However, transient right phrenic nerve palsy occurred only in CB group (10 patients, 5.6%; P = 0.001 vs. CF group) and severe non-lethal complications (embolic event, tamponade, or oesophageal injury) occurred only in CF group (5 patients, 2.5%; P = 0.03 vs. CB group). No periprocedural death occurred in either group. Single-procedure freedom from any atrial arrhythmias at 18 months post-ablation was comparable in CF group and CB group (76 vs. 73.3%, respectively, log rank P = 0.63). Conclusion Pulmonary vein isolation using CF-guided RF and second-generation CB leads to comparable single-procedure arrhythmia-free survival at up to 18 months with similar overall complication rate.

Axillary vein access for pacemaker implantation is uncommon in many centres because of the lack of training in this technique. We assessed whether the introduction of the axillary vein technique was safe and efficient as compared with cephalic vein access, in a centre where no operators had any previous experience in axillary vein puncture. Patients undergoing pacemaker implantation were randomized to axillary or cephalic vein access. All three operators had no experience nor training in axillary vein puncture, and self-learned the technique by reading a published review. Axillary vein puncture was fluoroscopy-guided without contrast venography. Cephalic access was performed by dissection of delto-pectoral groove. Venous access success, venous access duration (from skin incision to guidewire or lead in superior vena cava), procedure duration, X-ray exposure, and peri-procedural (1 month) complications were recorded. results We randomized 74 consecutive patients to axillary (n = 37) or cephalic vein access (n = 37). Axillary vein was successfully accessed in 30/37 (81.1%) patients vs. 28/37 (75.7%) of cephalic veins (P = 0.57). Venous access time was shorter in axillary group than in cephalic group [5.7 (4.4–8.3) vs. 12.2 (10.5–14.8) min, P < 0.001], as well as procedure duration [34.8 (30.6–38.4) vs. 42.0 (39.1–46.6) min, P = 0.043]. X-ray exposure and peri-procedural overall complications were comparable in both groups. Axillary puncture was safe and faster than cephalic access even for the five first procedures performed by each operator. Self-taught axillary vein puncture for pacemaker implantation seems immediately safe and faster than cephalic vein access, when performed by electrophysiologists trained to pacemaker implantation but not to axillary vein puncture.

Background: Classical fluoroscopic criteria for the documentation of septal right ventricular (RV) lead positioning have poor accuracy. We sought to evaluate the individualized left anterior oblique (LAO) projection as a novel fluoroscopy criterion. Methods: Consecutive patients undergoing pacemaker or defibrillator implantation were prospectively included. RV lead positioning was assessed by fluoroscopy using posteroanterior, right anterior oblique 30° to rule out coronary sinus positioning, and LAO 40° in the classical group or individualized LAO in the individualized group. Individualized LAO was defined by the degree of LAO that allowed the perfect superposition of the RV apex (using the tip of the RV lead temporarily placed at the apex) and of the superior vena cava-inferior vena cava axis (materialized by a guidewire), hence providing a true profile view of the interventricular septum. Accuracy of fluoroscopy for RV lead positioning was then assessed by comparison with true RV lead positioning using transthoracic echocardiography. Results: We included 100 patients, 50 in each study group. Agreement between RV lead septal/free wall positioning in transthoracic echocardiography and fluoroscopy was excellent in the individualized group (k=0.91), whereas it was poor in the classical group (k=0.35). Septal/free wall RV lead positioning was correctly identified in 48/50 (96%) patients in the individualized group versus 38/50 (76%) in the classical group ( P =0.004). For septal lead positioning, fluoroscopy had 100% Se and 89.5% Sp in the individualized group versus 91.4% Se and 40% Sp in the classical group. Complications and procedural data were comparable in both groups. Conclusion: Individualized LAO is a quick and highly reliable patient-tailored fluoroscopy projection for RV lead positioning.

Catheter ablation for atrial fibrillation (AF) including pulmonary vein isolation and possibly further substrate ablation is the most common electrophysiological procedure. Severe complications are uncommon, but their detailed assessment in a large worldwide cohort is lacking. The aim of this study was to determine the incidence of periprocedural severe complications and to provide a detailed characterization of the diagnostic evaluation and management of these complications in patients undergoing AF ablation. Individual patient data were collected from 23 centers worldwide. Limited data were collected for all patients who underwent catheter ablation, and an expanded series of data points were collected for patients who experienced severe complications during periprocedural follow-up. Incidence, predictors, patient characteristics, management details, and overall outcomes of patients who experienced ablation-related complications were investigated. Data were collected from 23 participating centers at which 33,879 procedures were performed (median age 63 years, 30% women, 71% radiofrequency ablations). The incidence of severe complications (n = 271) was low (tamponade 6.8‰, stroke 0.97‰, cardiac arrest 0.41‰, esophageal fistula 0.21‰, and death 0.21‰). Age, female sex, a dilated left atrium, procedure duration, and the use of radiofrequency energy were independently associated with the composite endpoint of all severe complications. Among patients experiencing tamponade, 13% required cardiac surgery. Ninety-three percent of patients with complications were discharged directly home after a median length of stay of 5 days (Q1-Q3: 3-7 days). This large worldwide collaborative study highlighted that tamponade, stroke, cardiac arrest, esophageal fistula, and death are rare after AF ablation. Older age, female sex, procedure duration, a dilated left atrium, and the use of radiofrequency energy were associated with severe complications in this multinational cohort. One in 8 patients with tamponade required cardiac surgery.