Pulsed field ablation confers successful outcomes in real-world population
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Key takeaways:
- In a real-world registry of patients who had pulsed field ablation for AF, complication rates were low and most patients did not have AF recurrence at 1 year.
- The operator learning curve was fast in most cases.
In the EU-PORIA real-world registry of patients with atrial fibrillation who underwent pulsed field ablation, most patients did not have recurrence at 1 year and the learning curve for operators was quick.
“EU-PORIA reflects data coming from seven European centers,” Boris Schmidt, MD, professor of medicine at Cardioangiologisches Centrum Bethanien in Frankfurt, Germany, told Healio. “We wanted to see how this new ablation technology is adopted in real life. What kind of patients are being treated with the device in which way? What is the ablation strategy that operators use? What is the patient population in terms of type of ablation? How do they use it in the clinical scenario? And then, of course, what is the risk for procedural complications and the benefits of this new ablation modality. We also wanted to see what the learning curve is for the operators.”
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The EU-PORIA registry included all 1,233 patients (mean age, 66 years; 39% women; 60% with paroxysmal AF; 45% with prior use of class I or III antiarrhythmic drugs) with AF treated with the pulsed field ablation system (Farawave, Farapulse/Boston Scientific) by 42 operators at seven high-volume centers between March 25, 2021, and May 31, 2022. The outcomes of interest presented by Schmidt at Heart Rhythm 2023 were procedural safety, freedom from atrial arrhythmias at 1 year and the operator learning curve stratified by years of previous AF ablation experience and by previous primary ablation modality.
Among the cohort, the mean skin-to-skin procedure time was 58 minutes, 80% had deep sedation and 14% had ablation beyond pulmonary vein isolation, according to the researchers.
The rate of major complications was 1.7%, with two-thirds being pericardial tamponade and the rest being stroke (including one fatal stroke) or transient ischemic attack, Schmidt said during a presentation. The rate of minor complications was 1.9%, the most common of which was vascular access site complications, he said.
The rate of freedom from AF/atrial tachycardia (AT) recurrence at 1 year was 74% (95% CI, 71-76), Schmidt said.
In a multivariate analysis, higher CHA2DS2-VASc score (OR = 1.104; 95% CI, 1.026-1.188; P = .008) and higher BMI (OR = 1.03; 95% CI, 1.008-1.053; P = .008) were associated with increased odds of AF/AT recurrence, whereas paroxysmal AF was associated with lower odds (OR = 0.577; 95% CI, 0.458-0.728; P < .001), according to the researchers.
The paroxysmal AF finding “highlights the findings that early treatment of atrial fibrillation is so important,” Schmidt told Healio. “Patients should not wait until they go into persistent forms of atrial fibrillation.”
The 1-year rate of freedom from AF/AT recurrence was highest in those with paroxysmal AF (80%) compared with persistent AF (66%) and longstanding persistent AF (67%; P for paroxysmal vs. persistent < .001; P for paroxysmal vs. longstanding persistent = .02; P for persistent vs. longstanding persistent = .7), Schmidt and colleagues found.
Skin-to-skin procedure time was highest in operators with more than 5 years of experience (P = .0878), but fluoroscopy time was highest in those with less than 2 years of experience (P = .0011), according to the researchers. There were no differences by experience in safety or efficacy measures.
The 1-year rate of freedom from AF/AT recurrence was 76% in procedures by operators with more than 5 years of experience, 72% in procedures by operators with 2 to 5 years of experience and 65% in procedures by operators with less than 2 years of experience, the researchers found.
“It’s important to see that pulsed field ablation can be used by a large subset of operators from different backgrounds in a very similar way,” Schmidt told Healio. “These results confirm the safety profile. Serious complications occurred early, but not after going through the learning curve. Even though this is early in the use of the technology, we can produce results consistent with technologies that have been around for many years.”
Skin-to-skin procedure time and fluoroscopy time were longest in operators whose previous experience was radiofrequency ablation compared with those experienced in cryoballoon ablation or those experienced in both (P for both < .001), Schmidt said, noting there was no difference by technology experience category in freedom from AF/AT recurrence at 1 year.
“People who are using point-by-point [radiofrequency] ablation do have a little more difficulties in adopting the workflow, but in turn, people who have experience with single-shot ablations like the cryoballoon do much better at adopting the workflow quickly,” he said.
Of interest, 55% of patients received pulsed field ablation without prior use of antiarrhythmic drugs, Schmidt told Healio.
“This is a very progressive approach because current guidelines only recommend primary ablation without previous treatment with drugs for select patients with heart failure,” he said. “Obviously, current clinical practice has already changed. European physicians are recommending ablation much earlier in the disease process. If this being the right approach is confirmed in future studies, then the demand for catheter ablation will rise dramatically. We would need more centers and operators performing more procedures in a shorter period of time. One of the strengths of [pulsed field ablation] is that procedure times are so quick and learning curves are so short that the growing demand for catheter ablation may be satisfied by this technology that eases the use for even unexperienced operators, and may increase the ability to increase case volume at centers.”
Perspective
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The recently presented data from the EU-PORIA registry informs us on the real-world outcomes from the use of pulsed field ablation as an energy source for ablation of AF. This was a registry including seven high-volume centers with over 1,200 cases of AF ablation in both paroxysmal and persistent patients. Results showed an impressive primary safety endpoint, with a 1.7% major complication rate and a 1.9% minor complication rate. The primary efficacy endpoint was in line with current efficacy outcomes using other sources of energy for ablation, with a cumulative freedom from AF and AT of 74% at one year. What was noted was a definite increase in procedural efficiency, with overall procedure times in the range of 1 hour for pulmonary vein isolation. Another noted take-home point was that operator experience with prior AF appeared to have no significant influence on clinical outcomes or safety in this registry.
The implications for clinical practice as a result of these data are that pulsed field ablation could likely replace the use of either cryothermal or radiofrequency energy for pulmonary vein isolation procedures within the next coming years. This will likely predominantly have an effect on procedural efficiency, without any significant compromise in either procedural safety or efficacy.
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Schmidt B, et al. Late Breaking Clinical Trials and Science – Atrial Fibrillation. Presented at: Heart Rhythm 2023; May 19-21, 2023; New Orleans (hybrid meeting).
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