We have developed a method to discriminate life-threatening ventricular arrhythmias by observing the QRS complex of the electrocardiogram (ECG) in each heartbeat. Changes in QRS complexes due to rhythm origination and conduction path were observed with the Fourier transform, and three kinds of rhythms were discriminated by a neural network. In this paper, the potential of our method for clinical uses and real-time detection was examined using human surface ECG's and intracardiac electrograms (EGM's). The method achieved high sensitivity and specificity (> or = 0.98) in discrimination of supraventricular rhythms from ventricular ones. We also present a hardware implementation of the algorithm on a commercial single-chip CPU.
Background:
The tissue selectivity of pulsed field ablation (PFA) provides safety advantages over radiofrequency ablation in treating atrial fibrillation. One-shot PFA catheters have been shown capable of performing pulmonary vein isolation, but not flexible lesion sets such as linear lesions. A novel lattice-tip ablation catheter with a compressible 9-mm nitinol tip is able to deliver either focal radiofrequency ablation or PFA lesions, each in 2 to 5 s.
Methods:
In a 3-center, single-arm, first-in-human trial, the 7.5F lattice catheter was used with a custom mapping system to treat paroxysmal or persistent atrial fibrillation. Toggling between energy sources, point-by-point pulmonary vein encirclement was performed using biphasic PFA posteriorly and either temperature-controlled irrigated radiofrequency ablation or PFA anteriorly (RF/PF or PF/PF, respectively). Linear lesions were created using either PFA or radiofrequency ablation.
Results:
The 76-patient cohort included 55 paroxysmal and 21 persistent atrial fibrillation patients undergoing either RF/PF (40 patients) or PF/PF (36 patients) ablation. The pulmonary vein isolation therapy duration time (transpiring from first to last lesion) was 22.6±8.3 min/patient, with a mean of 50.1 RF/PF lesions/patient. Linear lesions included 14 mitral (4 RF/2 RF+PF/8 PF), 34 left atrium roof (12 RF/22 PF), and 44 cavotricuspid isthmus (36 RF/8 PF) lines, with therapy duration times of 5.1±3.5, 1.8±2.3, and 2.4±2.1 min/patient, respectively. All lesion sets were acutely successful, using 4.7±3.5 minutes of fluoroscopy. There were no device-related complications, including no strokes. Postprocedure esophagogastroduodenoscopy revealed minor mucosal thermal injury in 2 of 36 RF/PF and 0 of 24 PF/PF patients. Postprocedure brain magnetic resonance imaging revealed diffusion-weighted imaging+/fluid-attenuated inversion recovery- and diffusion-weighted imaging+/fluid-attenuated inversion recovery+ asymptomatic lesions in 5 and 3 of 51 patients, respectively.
Conclusions:
A novel lattice-tip catheter could safely and rapidly ablate atrial fibrillation using either a combined RF/PF approach (capitalizing on the safety of PFA and the years of experience with radiofrequency energy) or an entirely PF approach.
Registration:
URL:
https://www.clinicaltrials.gov
; Unique identifiers: NCT04141007 and NCT04194307.
Both the uninterrupted and interrupted DOAC protocols revealed a low risk of symptomatic thromboembolisms and major bleeding events and similar incidence of SCILs and minor bleeding events and may be feasible for periprocedural anticoagulation in NVAF patients undergoing catheter ablation.
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