Cryoballoon ablation for persistent AF safe with low event rate
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Pulmonary vein isolation with cryoballoon ablation was safe and effective in patients with persistent atrial fibrillation during 12-month follow-up, according to data from the STOP Persistent AF trial.
Data from this trial supported the recent expanded FDA approval for the cardiac cryoablation catheter system (Arctic Front, Medtronic) for use in patients with persistent AF.
“This tells us that for a patient with early persistent atrial fibrillation, a treatment strategy focused on just simply getting rid of the high-yield area using pulmonary vein isolation with a quick lower-risk procedure such as the cryoballoon ablation is very effective in treating this,” Wilber W. Su, MD, chief of cardiac electrophysiology at Banner – University Medicine Heart Institute Phoenix, told Healio.
AF episodes up to 6 months
In the single-arm trial published in HeartRhythm, researchers analyzed data from 165 patients (mean age, 65 years, 70% men; left atrial diameter, 4.2 cm; BMI, 31 kg/m2) with drug-refractory with episodes that lasted longer than 7 days but shorter than 6 months. All patients underwent pulmonary vein isolation-only cryoballoon ablation.
“All of the approved products are focused on just [paroxysmal AF], which leaves probably most of the atrial fibrillation untreated, and there are not good data to guide physicians on what to do,” Su said in an interview. “This is looking at expanding the indication of ablation to beyond paroxysmal atrial fibrillation.”
Follow-up was conducted during a 12-month period that included phone calls, trans-telephonic monitoring and in-office visits. ECGs were recorded at each in-office visit at 3, 6 and 12 months, and 24-hour Holter monitoring was performed at 6 and 12 months.
The primary efficacy endpoint was 12-month freedom from 30 seconds or longer episodes of AF, atrial tachycardia or atrial flutter after a blanking period of 90 days. Secondary endpoints focused on quality of life assessed by SF-12 and the AF Effect on Quality of Life questionnaires, both of which were administered before the procedure, at 6 and 12 months.
The total procedure time was 121 minutes, with a left atrial dwell time of 102 minutes and a fluoroscopy time of 19 minutes.
The primary efficacy endpoint occurred in 54.8% of patients (95% CI, 46.7-62.1). One primary safety event occurred (0.6%; 95% CI, 0.1-4.4), which was an aortic root perforation during transseptal puncture that occurred during a planned repeat ablation at 163 days after the index procedure.
From baseline to 12 months, the AF Effect on Quality of Life score improved by 25.8 points (95% CI, 22.1-29.5; P < .001). Similar improvements were observed for the SF-12, which increased by 5 points during this time period (95% CI, 3.5-6.5; P < .001).
‘Robust evidence’
“Now we have very robust evidence to offer patients even with persistent atrial fibrillation that just going in to do a very defined procedure of ablating the pulmonary vein with cryoballoon procedure is a very viable approach,” Su told Healio. “For our center to do a cryoballoon ablation, it’s about a 1-hour process and a same-day discharge, and complication rates are exceedingly low. ... At the end of the day, what’s most important for any therapy is first do no harm, and cryoballoon fit that niche for the longest time, but we never knew if it was a great idea to use this product for persistent AF.”
For more information:
Wilber W. Su, MD, can be reached at wilwsu@gmail.com.
Perspective
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John D. Day, MD, FACC, FHRS
Studies on the impact of cryoballoon ablation for persistent AF are limited, especially with a more rigorous follow-up to determine arrhythmia recurrence.
There were several important findings from this study. No. 1, cryoballoon ablation was very safe with minimal complications. No. 2, using the cryoballoon to do pulmonary vein isolation for persistent AF had a success rate similar to other published trials for persistent AF.
The results of this study suggest that using the cryoballoon for persistent AF ablation is a reasonable strategy.
What we really need in the field is conclusive proof that ablating targets other than pulmonary vein isolation (this study only targeted the pulmonary veins) can meaningfully increase the success rate. Even though this study had rigorous follow-up, a 55% success rate for freedom from persistent AF at 1 year is not optimal.
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