AF pulsed-field ablation device clears safety, efficacy hurdles in pivotal trial: PULSED-AF. ACC23 WCCardio
Application of PFA for PVI, as described by Verma, creates the lesions by exposing the myocardial targets to high-gradient electric fields, leading to a nonthermal electroporation process that rapidly renders myocyte membranes"hyperpermeable," which induces apoptotic cell death.
That may bode well for PFA's uptake in practice should it be approved, Jim W. Cheung, MD, who is not part of PULSED-AF, told theheart.org | Medscape Cardiology. The PULSED-AF trial enrolled 383 adults with symptomatic paroxysmal or persistent AF despite antiarrhythmic meds at 41 centers in North America, Western Europe, Australia, and Japan.
The primary efficacy endpoint consisted of freedom from acute procedural failure, AF recurrence, repeat ablation, direct-current cardioversion, left atrial surgery, or escalation of antiarrhythmic drugs.
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