Pulsed Field Ablation for the Treatment of Atrial Fibrillation: PULSED AF Pivotal Trial
Pulsed field ablation uses electrical pulses to cause nonthermal irreversible electroporation and induce cardiac cell death. Pulsed field ablation may have effectiveness comparable to traditional catheter ablation while preventing thermally mediated complications. The PULSED AF pivotal study (Pulsed...
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| Published in | Circulation (New York, N.Y.) Vol. 147; no. 19; pp. 1422 - 1432 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Lippincott Williams & Wilkins
09.05.2023
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| Subjects | |
| Online Access | Get full text |
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| Abstract | Pulsed field ablation uses electrical pulses to cause nonthermal irreversible electroporation and induce cardiac cell death. Pulsed field ablation may have effectiveness comparable to traditional catheter ablation while preventing thermally mediated complications.
The PULSED AF pivotal study (Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF) was a prospective, global, multicenter, nonrandomized, paired single-arm study in which patients with paroxysmal (n=150) or persistent (n=150) symptomatic atrial fibrillation (AF) refractory to class I or III antiarrhythmic drugs were treated with pulsed field ablation. All patients were monitored for 1 year using weekly and symptomatic transtelephonic monitoring; 3-, 6-, and 12-month ECGs; and 6- and 12-month 24-hour Holter monitoring. The primary effectiveness end point was freedom from a composite of acute procedural failure, arrhythmia recurrence, or antiarrhythmic escalation through 12 months, excluding a 3-month blanking period to allow recovery from the procedure. The primary safety end point was freedom from a composite of serious procedure- and device-related adverse events. Kaplan-Meier methods were used to evaluate the primary end points.
Pulsed field ablation was shown to be effective at 1 year in 66.2% (95% CI, 57.9 to 73.2) of patients with paroxysmal AF and 55.1% (95% CI, 46.7 to 62.7) of patients with persistent AF. The primary safety end point occurred in 1 patient (0.7%; 95% CI, 0.1 to 4.6) in both the paroxysmal and persistent AF cohorts.
PULSED AF demonstrated a low rate of primary safety adverse events (0.7%) and provided effectiveness consistent with established ablation technologies using a novel irreversible electroporation energy to treat patients with AF.
URL: https://www.
gov; Unique identifier: NCT04198701. |
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| AbstractList | Pulsed field ablation uses electrical pulses to cause nonthermal irreversible electroporation and induce cardiac cell death. Pulsed field ablation may have effectiveness comparable to traditional catheter ablation while preventing thermally mediated complications.BACKGROUNDPulsed field ablation uses electrical pulses to cause nonthermal irreversible electroporation and induce cardiac cell death. Pulsed field ablation may have effectiveness comparable to traditional catheter ablation while preventing thermally mediated complications.The PULSED AF pivotal study (Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF) was a prospective, global, multicenter, nonrandomized, paired single-arm study in which patients with paroxysmal (n=150) or persistent (n=150) symptomatic atrial fibrillation (AF) refractory to class I or III antiarrhythmic drugs were treated with pulsed field ablation. All patients were monitored for 1 year using weekly and symptomatic transtelephonic monitoring; 3-, 6-, and 12-month ECGs; and 6- and 12-month 24-hour Holter monitoring. The primary effectiveness end point was freedom from a composite of acute procedural failure, arrhythmia recurrence, or antiarrhythmic escalation through 12 months, excluding a 3-month blanking period to allow recovery from the procedure. The primary safety end point was freedom from a composite of serious procedure- and device-related adverse events. Kaplan-Meier methods were used to evaluate the primary end points.METHODSThe PULSED AF pivotal study (Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF) was a prospective, global, multicenter, nonrandomized, paired single-arm study in which patients with paroxysmal (n=150) or persistent (n=150) symptomatic atrial fibrillation (AF) refractory to class I or III antiarrhythmic drugs were treated with pulsed field ablation. All patients were monitored for 1 year using weekly and symptomatic transtelephonic monitoring; 3-, 6-, and 12-month ECGs; and 6- and 12-month 24-hour Holter monitoring. The primary effectiveness end point was freedom from a composite of acute procedural failure, arrhythmia recurrence, or antiarrhythmic escalation through 12 months, excluding a 3-month blanking period to allow recovery from the procedure. The primary safety end point was freedom from a composite of serious procedure- and device-related adverse events. Kaplan-Meier methods were used to evaluate the primary end points.Pulsed field ablation was shown to be effective at 1 year in 66.2% (95% CI, 57.9 to 73.2) of patients with paroxysmal AF and 55.1% (95% CI, 46.7 to 62.7) of patients with persistent AF. The primary safety end point occurred in 1 patient (0.7%; 95% CI, 0.1 to 4.6) in both the paroxysmal and persistent AF cohorts.RESULTSPulsed field ablation was shown to be effective at 1 year in 66.2% (95% CI, 57.9 to 73.2) of patients with paroxysmal AF and 55.1% (95% CI, 46.7 to 62.7) of patients with persistent AF. The primary safety end point occurred in 1 patient (0.7%; 95% CI, 0.1 to 4.6) in both the paroxysmal and persistent AF cohorts.PULSED AF demonstrated a low rate of primary safety adverse events (0.7%) and provided effectiveness consistent with established ablation technologies using a novel irreversible electroporation energy to treat patients with AF.CONCLUSIONSPULSED AF demonstrated a low rate of primary safety adverse events (0.7%) and provided effectiveness consistent with established ablation technologies using a novel irreversible electroporation energy to treat patients with AF.URL: https://www.REGISTRATIONURL: https://www.gov; Unique identifier: NCT04198701.CLINICALTRIALSgov; Unique identifier: NCT04198701. Pulsed field ablation uses electrical pulses to cause nonthermal irreversible electroporation and induce cardiac cell death. Pulsed field ablation may have effectiveness comparable to traditional catheter ablation while preventing thermally mediated complications. Pulsed field ablation uses electrical pulses to cause nonthermal irreversible electroporation and induce cardiac cell death. Pulsed field ablation may have effectiveness comparable to traditional catheter ablation while preventing thermally mediated complications. The PULSED AF pivotal study (Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF) was a prospective, global, multicenter, nonrandomized, paired single-arm study in which patients with paroxysmal (n=150) or persistent (n=150) symptomatic atrial fibrillation (AF) refractory to class I or III antiarrhythmic drugs were treated with pulsed field ablation. All patients were monitored for 1 year using weekly and symptomatic transtelephonic monitoring; 3-, 6-, and 12-month ECGs; and 6- and 12-month 24-hour Holter monitoring. The primary effectiveness end point was freedom from a composite of acute procedural failure, arrhythmia recurrence, or antiarrhythmic escalation through 12 months, excluding a 3-month blanking period to allow recovery from the procedure. The primary safety end point was freedom from a composite of serious procedure- and device-related adverse events. Kaplan-Meier methods were used to evaluate the primary end points. Pulsed field ablation was shown to be effective at 1 year in 66.2% (95% CI, 57.9 to 73.2) of patients with paroxysmal AF and 55.1% (95% CI, 46.7 to 62.7) of patients with persistent AF. The primary safety end point occurred in 1 patient (0.7%; 95% CI, 0.1 to 4.6) in both the paroxysmal and persistent AF cohorts. PULSED AF demonstrated a low rate of primary safety adverse events (0.7%) and provided effectiveness consistent with established ablation technologies using a novel irreversible electroporation energy to treat patients with AF. URL: https://www. gov; Unique identifier: NCT04198701. |
| Author | Onal, Birce Packer, Douglas L. Cerkvenik, Jeffrey Boersma, Lucas V. Marchlinski, Francis E. Verma, Atul Sood, Nitesh Sanders, Prashanthan Tada, Hiroshi Calkins, Hugh Kuck, Karl-Heinz DeLurgio, David B. Natale, Andrea Hindricks, Gerhard Haines, David E. |
| AuthorAffiliation | Heart Center, University of Leipzig, Germany (G.H.) Beaumont Health, Royal Oak, MI (D.E.H.) Southcoast Health Center, Fall River, MA (N.S.) Johns Hopkins Hospital, Baltimore, MD (H.C.) Medtronic, Inc, Minneapolis, MN (B.O., J.C.) Emory Heart & Vascular Center at St. Joseph’s, Atlanta, GA (D.B.D.) St. Antonius Hospital, Nieuwegein and Amsterdam UMC, the Netherlands (L.V.B.) LANS Cardio, Hamburg, Germany (K.-H.K.) University of Fukui, Japan (H.T.) Mayo Clinic–St. Mary’s Hospital, Rochester, MN (D.L.P.) McGill University Health Centre, Montreal, Canada (A.V.) University of Adelaide & Royal Adelaide Hospital, Australia (P.S.) Hospital of the University of Pennsylvania, Philadelphia (F.E.M.) Texas Cardiac Arrhythmia Institute, Austin (A.N.) |
| AuthorAffiliation_xml | – name: McGill University Health Centre, Montreal, Canada (A.V.) – name: Beaumont Health, Royal Oak, MI (D.E.H.) – name: Medtronic, Inc, Minneapolis, MN (B.O., J.C.) – name: Heart Center, University of Leipzig, Germany (G.H.) – name: LANS Cardio, Hamburg, Germany (K.-H.K.) – name: University of Fukui, Japan (H.T.) – name: Mayo Clinic–St. Mary’s Hospital, Rochester, MN (D.L.P.) – name: Texas Cardiac Arrhythmia Institute, Austin (A.N.) – name: Johns Hopkins Hospital, Baltimore, MD (H.C.) – name: Southcoast Health Center, Fall River, MA (N.S.) – name: University of Adelaide & Royal Adelaide Hospital, Australia (P.S.) – name: St. Antonius Hospital, Nieuwegein and Amsterdam UMC, the Netherlands (L.V.B.) – name: Hospital of the University of Pennsylvania, Philadelphia (F.E.M.) – name: Emory Heart & Vascular Center at St. Joseph’s, Atlanta, GA (D.B.D.) |
| Author_xml | – sequence: 1 givenname: Atul surname: Verma fullname: Verma, Atul organization: McGill University Health Centre, Montreal, Canada (A.V.) – sequence: 2 givenname: David E. surname: Haines fullname: Haines, David E. organization: Beaumont Health, Royal Oak, MI (D.E.H.) – sequence: 3 givenname: Lucas V. surname: Boersma fullname: Boersma, Lucas V. organization: St. Antonius Hospital, Nieuwegein and Amsterdam UMC, the Netherlands (L.V.B.) – sequence: 4 givenname: Nitesh surname: Sood fullname: Sood, Nitesh organization: Southcoast Health Center, Fall River, MA (N.S.) – sequence: 5 givenname: Andrea surname: Natale fullname: Natale, Andrea organization: Texas Cardiac Arrhythmia Institute, Austin (A.N.) – sequence: 6 givenname: Francis E. surname: Marchlinski fullname: Marchlinski, Francis E. organization: Hospital of the University of Pennsylvania, Philadelphia (F.E.M.) – sequence: 7 givenname: Hugh surname: Calkins fullname: Calkins, Hugh organization: Johns Hopkins Hospital, Baltimore, MD (H.C.) – sequence: 8 givenname: Prashanthan surname: Sanders fullname: Sanders, Prashanthan organization: University of Adelaide & Royal Adelaide Hospital, Australia (P.S.) – sequence: 9 givenname: Douglas L. surname: Packer fullname: Packer, Douglas L. organization: Mayo Clinic–St. Mary’s Hospital, Rochester, MN (D.L.P.) – sequence: 10 givenname: Karl-Heinz surname: Kuck fullname: Kuck, Karl-Heinz organization: LANS Cardio, Hamburg, Germany (K.-H.K.) – sequence: 11 givenname: Gerhard surname: Hindricks fullname: Hindricks, Gerhard organization: Heart Center, University of Leipzig, Germany (G.H.) – sequence: 12 givenname: Birce surname: Onal fullname: Onal, Birce organization: Medtronic, Inc, Minneapolis, MN (B.O., J.C.) – sequence: 13 givenname: Jeffrey surname: Cerkvenik fullname: Cerkvenik, Jeffrey organization: Medtronic, Inc, Minneapolis, MN (B.O., J.C.) – sequence: 14 givenname: Hiroshi surname: Tada fullname: Tada, Hiroshi organization: University of Fukui, Japan (H.T.) – sequence: 15 givenname: David B. surname: DeLurgio fullname: DeLurgio, David B. organization: Emory Heart & Vascular Center at St. Joseph’s, Atlanta, GA (D.B.D.) |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/36877118$$D View this record in MEDLINE/PubMed |
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| Title | Pulsed Field Ablation for the Treatment of Atrial Fibrillation: PULSED AF Pivotal Trial |
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