CRYO4PERSISTENT AF: Cryoballoon ablation improved outcomes at 1 year

Serge Boveda

MUNICH — Treatment of persistent atrial fibrillation with a single pulmonary vein isolation-only ablation procedure using a second-generation cryoballoon was successful, significantly reduced AF-related symptoms and improved quality of life, according to data presented at the European Society of Cardiology Congress.

“These findings make a significant contribution to the body of clinical evidence that support a [pulmonary vein isolation]-only ablation as a reasonable treatment option for patients with [persistent] AF,” Serge Boveda, MD, of the department of rhythmology at Clinique Pasteur in Toulouse, France, and colleagues wrote in a simultaneous publication in JACC: Clinical Electrophysiology.

The CRYO4PERSISTENT AF trial enrolled 101 patients (mean age, 62 years; 74% men; left ventricular ejection fraction, 56%; left atrial diameter, 43 mm) with persistent AF who underwent a single cryoballoon ablation procedure. At least one antiarrhythmic drug prescription failed or was refused before the procedure.

Mean procedure time was 53 minutes with the cryoballoon. Pulmonary vein isolation was achieved in 98% of patients with a 28-mm balloon; 2% of patients required additional ablation with a 23-mm size balloon.

Only three patients in sinus rhythm remained on antiarrhythmic medication at study completion, according to a press release.

At 12 months, freedom from AF, atrial flutter and atrial tachycardia 30 seconds or more after a 90-day blanking period, occurred in 60.7% of patients. In the failure group, 17 patients required a repeat ablation and eight patients required cardioversion at the time of an arrhythmia recurrence. The primary result was presented in March at EHRA 2018, the Annual Congress of the European Heart Rhythm Association.

In new results, fewer patients had arrhythmia-related symptoms at 12 months after the procedure compared with baseline (16% vs. 92%; P < .0001). Symptom reduction was statistically significant at 12 months for all except syncope: dizziness, rapid heartbeat, palpitations, fatigue and dyspnea (P for all < .01). Severity of symptoms also decreased after cryoballoon treatment, from 2.1 to 1.3 (P < .01) using the European Heart Rhythm Association AF Symptom Score. NYHA class HF improved by one or more functional class in 47% of patients from baseline to 12 months, according to the release.

Symptom reduction was supported by significant improvements in quality-of-life scores at 12 months. Patients treated with cryoballoon ablation experienced a 7.1-point average improvement in physical quality and a 3.3-point average improvement in mental health quality component scores using the SF-36 Short Form Health Survey, according to the release.

The complication rate was low at 4%. Transient phrenic nerve injury was the only cryoballoon-related complication, which was reported in 2% of patients and resolved before hospital discharge.

“The results of this study complement earlier findings and appear to suggest that a pulmonary vein isolation-only approach using exclusively the cryoballoon is a reasonable first-line ablation strategy for the treatment of symptomatic persistent AF as recommended in the 2016 European Society of Cardiology Guidelines and 2017 Heart Rhythm Society/[European Heart Rhythm Association] consensus statement,” the researchers wrote in the JACC: Clinical Electrophysiology.

Suneet Mittal, MD, director of the electrophysiology laboratory at The Valley Hospital in Ridgewood, New Jersey, discussed the findings in an editorial published in JACC: Clinical Electrophysiology.

“The simplicity and low complication rate are admirable and attractive; the 12-month efficacy seems comparable to reports using [radiofrequency] energy and other lesion sets but far from where patients and clinicians expect from the index ablation procedure.

“In the end, depending on your perspective, the glass remains either half full or half empty when it comes to using the cryoballoon in patients with persistent AF.” – by Darlene Dobkowski

References:

Chun J, et al. Abstract P5761. Presented at: European Society of Cardiology Congress; Aug. 25-29, 2018; Munich.

Boveda S, et al. JACC Clin Electrophysiol. 2018;doi:10.1016/j.jacep.2018.07.007.

Mittal S. JACC Clin Electrophysiol. 2018;doi:10.1016/j.jacep.2018.08.004.

Disclosures: The trial was funded by Medtronic. Boveda reports he received consultant fees from Boston Scientific, Livanova and Medtronic. Mittal reports he consults and has received honoraria from Abbott, Boston Scientific, Medtronic and SentreHeart. Please see the study for all other authors’ relevant financial disclosures.