What is the clinical evidence from this study?

Study design: Other. Population: Symptomatic persistent atrial fibrillation (PersAF) (n=23). Intervention: Cryoballoon-based pulmonary vein isolation (PVI) plus left atrial appendage isolation (LAAI) followed by LAA closure. Primary outcome: Durable LAA isolation at remapping.

April 16, 2026Open Access

Cryoballoon-Based Left Atrial Appendage Isolation and Closure in Patients with Atrial Fibrillation—The LALALAND Pilot Study

Key Result

Cryoballoon-based left atrial appendage isolation (LAAI) achieved durable isolation in 74% of patients but was associated with a 26% rate of LAA thrombus formation prior to closure.

Key Points

The study aims to evaluate the clinical impact of cryoballoon-based left atrial appendage isolation in patients with persistent atrial fibrillation.
Prospective, interventional, single-centre design
Enrolled consecutive patients with symptomatic persistent atrial fibrillation
Performed pulmonary vein isolation plus left atrial appendage isolation using cryoballoon
Conducted percutaneous LAA closure 2-3 months after ablation
Assessed LAA isolation durability using invasive remapping studies.
100% of pulmonary veins were successfully isolated using the cryoballoon technology
91% of left atrial appendage isolations remained effective post-procedure
LAA thrombus formation occurred in 26% of patients after isolation
Durability of LAA isolation successful in 74% of patients
65% of patients maintained stable sinus rhythm during follow-up of 13 months.

Structured PICO

Does cryoballoon-based left atrial appendage isolation and closure in addition to pulmonary vein isolation improve outcomes in patients with persistent atrial fibrillation?

Population

23 consecutive patients with symptomatic persistent atrial fibrillation (PersAF)

Intervention

Pulmonary vein isolation (PVI) plus left atrial appendage isolation (LAAI) using a cryoballoon system, followed by percutaneous LAA closure within 2-3 months

Outcome

Clinical impact of CB-based LAAI in addition to PVI, including LAAI durability, LAA thrombus formation, and sinus rhythm maintenance

Cryoballoon-based LAA isolation in persistent AF achieves durable isolation and rhythm control but carries a significant risk of LAA thrombus formation, necessitating early LAA closure.

Limitations

Significant risk of thrombus formation in the LAA, even with appropriate OAC
Further evidence is needed to establish clear best practices

Abstract

Background: Atrial fibrillation (AF) remains the most common cardiac arrhythmia, with pulmonary vein isolation (PVI) established as the cornerstone of interventional treatment. However, in patients with persistent AF (PersAF), the success rates of PVI alone tend to be limited. A promising additional target is the left atrial appendage (LAA). In recent years, cryoballoon (CB) technology has become a tool for achieving durable PVI. Its application for LAAI has been investigated as a potentially advantageous alternative to radiofrequency ablation, and a positive effect on long-term outcome has been reported. However, the available data is limited. This study sought to investigate the clinical impact of CB-based LAAI in addition to PVI. Methods: This is a prospective, interventional, single-centre study. Consecutive patients with symptomatic PersAF were prospectively enrolled. In total 23 patients with PersAF underwent PVI plus LAAI using the CB system. Percutaneous LAA closure was performed within 2–3 months in all patients by implanting an endocardial LAA-closure device. Prior to LAA closure, LAAI durability was systematically assessed by invasive remapping studies. Results: A total of 100% of PVs were successfully isolated using the CB only (n = 91/91). Concerning LAAIs, a total of 21/23 (91%) remained isolated at the end of the procedure. After the ablation procedure including LAAI, all patients were scheduled for TEE assessment and LAA closure. TEE was performed after a mean of 54 ± 19 days. In 6/23 (26%) patients, LAA thrombus formation was detected after LAAI. A total of 23/23 patients (100%) received LAAC after a mean of 72 ± 45 days. Durability of LAAI was assessed utilizing a spiral mapping catheter in 23/23 patients (100%). In a total of 17/23 (74%) patients, durable LAA isolation was detected. Durable PVI of all PVs was detected in 16/23 (70%) patients. During a mean follow-up of 13 ± 3.4 months, stable sinus rhythm was maintained in 15 (65%) patients. The LAA showed reconnection in 3/23 (13%) patients, with arrhythmia recurrence. During follow-up, one stroke (318 days after LAAC) and one device thrombus (56 days after LAAC) occurred. Conclusions: While CB-based LAAI may offer benefits in managing persistent AF, it presents a significant risk of thrombus formation in the LAA, even with appropriate OAC. Early closure of the LAA following LAAI appears promising in mitigating these risks, but further evidence is needed to establish clear best practices.