Varipulse Shows 8-Fold Higher Incidence of Silent Cerebral Lesions Compared to PulseSelect in First Head-to-Head Circular PFA Clinical Study

Medtronic in the journal "Circulation:Arrhythmia and Electrophysiology》Publish an article about its PFA ablation catheterPulseSelect and Johnson & Johnson PFA Ablation CatheterClinical Research of VaripulseStudy. Research shows:AndVaripulseIn comparison,PulseSelectThe SCL rate was significantly reduced.

This StudyIt was a single-center study that consecutively enrolled 16 cases.Patients with atrial fibrillation (Control group:n=7, Experimental group: n=9), these patients underwent PFA pulmonary vein isolation (PVI) between June and September 2024. Experimental group:PulseSelect+EnSite (Abbott), Control Group:Varipulse+CARTOAll procedures were performed by the same experienced operator (S.M.; >1500 cases of radiofrequency ablation; >1000 cases of cryoballoon) to minimize the impact of procedural variability on outcomes.

Specific Research Results

• Detected in 8 patients (50.0%)Asymptomatic BrainInjury (SCL), all patients had multiple lesions. Seven patients had medium-sized lesions, and three patients had larger lesions. The incidence of SCL in the control group (6/7, 85.7%) was significantly higher than that in the experimental group (2/9, 22.2%), P=0.04. Patients in the control group had 13 (3-19) lesions; compared with the experimental group, the incidence of SCL (6/7 [85.7%] vs. 1/9 [11.1%]; P<0.01) and the incidence of medium/large lesions (6/7 [85.7%] vs. 1/9 [11.1%]; P<0.01) were significantly higher in the control group. Three patients in the control group had larger lesions (21, 13, and 10 mm).

• The activated clotting time of the control group was maintained at >350 seconds, while that of the experimental group was maintained at >300 seconds.

• The total number of PFA ablations (55.6±4.2 vs. 32.4±2.5; P<0.001) and the total number of released pulses (222.2±17.0 vs. 97.3±7.5; P<0.001) in the control group were both significantly higher than those in the experimental group.

• The operation time in the left atrium (69.1±7.7 vs. 66.0±12.2 minutes; P=0.56), the interval between the first and last ablation (54.1±7.7 vs. 46.9±7.2 minutes; P=0.07), and the interval between the first and last ablation for PVI (26.8±5.4 vs. 26.3±6.3 minutes; P=0.86) were similar between the control group and the experimental group.

• All procedures were performed using a single PFA catheter via a single transseptal access without catheter exchange, except for one patient in the trial group.

These single-center clinical studies have shown that Medtronic'sPulseSelect vs. Johnson & JohnsonVaripulse Has LowerIncidence of SCL. However, this study has significant limitations: it is a single-center study involving very few patients, and the research was conducted before October of last year.

Johnson & Johnson this yearMarch UpdateVaripulse Instructions for Use, AfterwardsVaripulse Treatment RelatedNerveBlood VesselThe incidence has dropped significantly. Of course, the current clinical research dataVaripulseThe incidence of asymptomatic stroke is still higher than that of mainstream PFA products (InspIRE Study Shows OptimizationAfter the workflowThe incidence of asymptomatic stroke was 12.1%, whilePulseSelectPULSED-AF Study ShowsThe incidence rate of asymptomatic stroke is 8.9%.）。

The neurovascular issues triggered by Varipulse treatment remain Johnson & Johnson Electrophysiology's biggest pain point and Achilles' heel, often targeted by giants like Medtronic and Boston Scientific. It is hoped that Johnson & Johnson will further optimize this aspect in the future to eliminate this weakness.