BACKGROUND: Catheter ablation of ventricular arrhythmias, one of the most rapidly growing procedures in cardiac electrophysiology, is associated with magnetic resonance imaging–detected brain lesions in more than half of cases. Although a retrograde aortic approach is conventional, modern tools enable entry through a transseptal approach that may avoid embolization of debris from the arterial system. We sought to test the hypothesis that a transseptal puncture would mitigate brain injury compared with a retrograde aortic approach. METHODS: The TRAVERSE trial (Transseptal Versus Retrograde Aortic Ventricular Entry to Reduce Systemic Emboli) was a multicenter randomized controlled comparative effectiveness trial. Patients with left ventricular arrhythmias undergoing catheter ablation procedures were randomly assigned to a transseptal puncture approach compared (1:1) with a retrograde aortic approach. The primary outcome was the presence of an acute brain lesion detected by magnetic resonance imaging. Secondary outcomes included clinically manifest complications, procedural efficacy, and 6-month neurocognitive assessments. RESULTS: Among the 62 patients randomly assigned to a retrograde aortic approach with postoperative brain magnetic resonance imaging, 28 (45%) exhibited an acute brain lesion compared with 19 of the 69 (28%) of those randomized to a transseptal puncture ( P =0.036). No differences in clinically manifest complications or procedural efficacy were observed. More patients in the retrograde aortic arm were categorized as having a high likelihood of cognitive impairment at 6 months (33% compared with 19% of those in the transseptal arm), but substantial loss to follow-up was present. CONCLUSIONS: Among patients undergoing left ventricular catheter ablation procedures, a transseptal approach reduced the risk of acute brain lesions by nearly half compared with a retrograde aortic approach without sacrificing safety or efficacy. Given a likely embolic pathogenesis, the brain magnetic resonance imaging findings may reflect a propensity to other organ damage; these findings may extend to other procedures requiring left ventricular entry. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03946072.
Use of three-dimensional electroanatomic mapping for epicardial access: needle tracking, electrographic characteristics, and clinical application
Abstract Aims Pericardiocentesis is usually completed under fluoroscopy. The electroanatomic mapping (EAM) system allows visualizing puncture needle tip (NT) while displaying the electrogram recorded from NT, making it possible to obtain epicardial access (EA) independent of fluoroscopy. This study was designed to establish and validate a technique by which EA is obtained under guidance of three-dimensional (3D) EAM combined with NT electrogram. Methods and results 3D shell of the heart was generated, and the NT was made trackable in the EAM system. Unipolar NT electrogram was continuously monitored. Penetration into pericardial sac was determined by an increase in NT potential amplitude and an injury current. A long guidewire of which the tip was also visible in the EAM system was advanced to confirm EA. Epicardial access was successfully obtained without complication in 13 pigs and 22 patients. In the animals, NT potential amplitude was 3.2 ± 1.0 mV when it was located in mediastinum, 5.2 ± 1.6 mV when in contact with fibrous pericardium, and 9.8 ± 2.8 mV after penetrating into pericardial sac (all P ≤ 0.001). In human subjects, it measured 1.54 ± 0.40 mV, 3.61 ± 1.08 mV, and 7.15 ± 2.88 mV, respectively (all P < 0.001). Fluoroscopy time decreased in every 4–5 cases (64 ± 15, 23 ± 17, and 0 s for animals 1–4, 5–8, 9–13, respectively, P = 0.01; 44 ± 23, 31 ± 18, 4±7 s for patients 1–7, 8–14, 15–22, respectively, P < 0.001). In five pigs and seven patients, EA was obtained without X-ray exposure. Conclusion By tracking NT in the 3D EAM system and continuously monitoring the NT electrogram, it is feasible and safe to obtain EA with minimum or no fluoroscopic guidance.
Incidence and Clinical Significance of New-Onset Device-Detected Atrial Tachyarrhythmia
Background: Despite the clear association between atrial fibrillation and risk for thromboembolic events (TEs), the clinical significance of new-onset device-detected atrial tachyarrhythmia (DDAT) and TE remains disputed. We aimed to determine the risk of TE in patients with new-onset DDAT. Methods and Results: The OVID Medline, Cochrane, and Scopus databases (inception to November 2016) were searched. Randomized controlled trials, prospective, or retrospective studies of pacemaker or defibrillator patients reporting incidence of DDAT were selected. Summary statistics were used for analysis. Of 4893 reports identified, 28 studies following 24 984 patients were included: average age 69.9 years, 34.7% women, mean study duration 21.8±18.6 months. New-onset DDAT was observed in 23% of patients. Among 9 studies (n=8181) reporting TE, the absolute incidence was 2.1%. TE risk was significantly greater among patients with new-onset DDAT (relative risk [RR], 2.88; 95% CI, 1.79–4.64; P <0.001). TE risk was correlated with DDAT duration, with an increased risk associated with DDAT ≥5 minutes (RR, 3.86; 95% CI, 2.04–7.30; P <0.001) compared with <1 minute (RR, 1.77; 95% CI, 1.15–2.74; P =0.01). Notably, the risk of TE was also increased in patients with adjudicated atrial electrograms (RR, 3.60; 95% CI, 2.06–6.30; P <0.001) compared with nonadjudicated electrograms (RR, 2.05; 95% CI, 1.06–3.97; P =0.03), even when lower mean thresholds for detection were used. Conclusions: New-onset DDAT is common, affecting close to one quarter of all patients with implanted pacemakers or defibrillators. Adjudication of atrial electrograms further identifies at-risk patients, even when relatively short detection thresholds are used.