Left Atrial Ridge Edema After VARIPULSE pulsed field ablation: Correlation With Early Peri-device leak

Q: What are the key findings of this study?

Combined VARIPULSE pulsed field ablation and LAAO increased LAA ridge thickness by 1.21 mm (30.45%, P<0.001) while achieving 100% complete sealing (0% peri-device leak) at 90 days.

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: Atrial fibrillation (n=40). Intervention: VARIPULSE pulsed field ablation combined with left atrial appendage occlusion (Watchman FLX or LACbes) vs. Pre-ablation baseline (single-arm study). Primary outcome: Presence of residual shunt (peri-device leak) of the left atrial appendage occluder at 90 days, alongside acute change in LAA ridge thickness (MD 1.21 mm, 95% CI 0.96-1.47, p=<0.001).

Q: What does this research mean for the field?

Combined VARIPULSE pulsed field ablation and left atrial appendage occlusion induces significant acute left atrial ridge edema without compromising 90-day device sealing or increasing peri-device leak. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.NEUTRAL.

Q: What question did this study set out to answer?

To assess procedural safety, left atrial ridge anatomical changes, and early peri-device leak following combined VARIPULSE pulsed field ablation and left atrial appendage occlusion.

Ké Li; Rui wang; Jia Qi Jin; Mingyu Wang; Qiuxia Duan; Ying Zhang; Zongjun Liu

doi:10.21203/rs.3.rs-10987861/v1

October 22, 2026Open Access

Left Atrial Ridge Edema After VARIPULSE pulsed field ablation: Correlation With Early Peri-device leak

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Key result

Combined PFA and LAAO thickens the ridge by ~1.2 mm while maintaining 100% sealing.

MD +1.21 mm
95% CI 0.96-1.47
P<0.001
n=40

Why the study?

Clinical studies of combined pulsed field ablation and left atrial appendage occlusion for atrial fibrillation mainly focus on procedural safety and recurrent arrhythmia, while subtle post-ablation anatomical changes in the left atrial ridge remain rarely recognized and scarce in Chinese domestic literature.

Does combined one-stage pulsed field ablation using the VARIPULSE system and left atrial appendage occlusion affect left atrial appendage ridge thickness and 90-day peri-device leak in patients with atrial fibrillation?

Key Points

To assess procedural safety, left atrial ridge anatomical changes, and early peri-device leak following combined VARIPULSE pulsed field ablation and left atrial appendage occlusion.
Single-center retrospective cohort study of 40 consecutive patients with atrial fibrillation undergoing combined pulsed field ablation and left atrial appendage occlusion.
Left atrial appendage ridge thickness and orifice diameter were measured by transesophageal echocardiography immediately before and after pulsed field ablation.
Pulmonary vein isolation was performed using the VARIPULSE system, followed by occluder implantation using Watchman FLX (21/40) or LACbes (19/40), with follow-up at 90 days.
Left atrial ridge thickness increased significantly from 4.10±0.71 mm pre-ablation to 5.31±0.89 mm post-ablation, an increase of 1.21±0.50 mm (95% CI: 0.96–1.47 mm, P<0.001) or 30.45±12.69%.
Implantation was successful in 40 of 40 patients (100%), and complete sealing with 0 mm peri-device leak was confirmed in 100% of patients at 90-day follow-up.
No deaths, strokes, major bleeding events, device-related thrombi, device embolizations, or intervention-requiring pericardial effusions occurred perioperatively or through 90 days.

Study Design

Type

Cohort (n=40)

Multicenter

No

Structured PICO

Does combined one-stage pulsed field ablation using the VARIPULSE system and left atrial appendage occlusion affect left atrial appendage ridge thickness and 90-day peri-device leak in patients with atrial fibrillation?

P

Population

40 Chinese patients (mean age 70.8 years, 47.1% female) with paroxysmal or persistent atrial fibrillation undergoing combined pulsed field ablation and left atrial appendage occlusion, followed for 90 days.

E

Exposure

Combined one-stage pulsed field ablation (PFA) for pulmonary vein isolation (PVI-only in 15%, PVI plus left atrial posterior wall ablation in 85%) using the VARIPULSE system, immediately followed by left atrial appendage occlusion (LAAO) using Watchman FLX (21/40) or LACbes (19/40) devices guided by transesophageal echocardiography (TEE), with post-procedural oral anticoagulation for up to 90 days.

O

Outcome

Presence of residual shunt (peri-device leak) of the left atrial appendage occluder at 90 days evaluated by contrast-enhanced cardiac computed tomography or transesophageal echocardiography, and immediate post-procedural change in left atrial appendage ridge thickness measured via transesophageal echocardiography.surrogate

Main Result

Mean Difference: 1.21 (95% CI 0.96–1.47)

Absolute Event Rate: 5.31% vs 4.1%

p-value: p=<0.001

Limitations

Single-center retrospective observational design with a small sample size of 40 patients, limiting generalizability and potentially introducing selection bias
Follow-up duration was limited to 90 days, leaving long-term efficacy and safety outcomes unclear
Only quantified immediate thickening of the LAA ridge after PFA without exploring dynamic changes during long-term follow-up
Absence of a control group (such as radiofrequency ablation combined with LAAO or simple LAAO)
All procedures were performed by experienced physicians in a specialized cardiovascular center
Single-center, retrospective observational study with a relatively small sample size of 40 patients, limiting generalizability and introducing potential selection bias
Follow-up duration limited to 90 days, leaving long-term efficacy and safety outcomes unclear
All operations were performed by experienced physicians in a specialized cardiovascular center

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Implication

Combined one-stage VARIPULSE pulsed field ablation and left atrial appendage occlusion is safe and feasible, demonstrating that despite an immediate 30.45% increase in left atrial appendage ridge thickness post-ablation, 100% complete device sealing with zero peri-device leak is achieved at 90 days.

Abstract

Background: Pulsed field ablation (PFA) combined with left atrial appendage occlusion (LAAO) is an emerging one-step strategy for atrial fibrillation. Current clinical studies mainly focus on procedural safety and recurrent arrhythmia, while subtle anatomical changes after PFA, especially alterations of the left atrial ridge, are rarely recognized. This cohort represents a preliminary real-world experience of one-stage PFA+LAAO using the VARIPULSE system in Chinese patients, where related anatomical morphological data remain scarce in domestic literature. Methods: In this single-center retrospective cohort study, 40 consecutive patients underwent combined PFA and LAAO. LAA ridge thickness and LAA orifice diameter were measured via transesophageal echocardiography before and after ablation.The primary follow-up endpoint at 90 days was the presence of residual shunt of the LAA occluder. Periprocedural adverse events were analyzed descriptively as secondary outcomes. Results: Implant success was achieved in all 40 patients (100%), with no deaths, strokes, major bleeding events, or intervention-requiring pericardial effusions observed. No complications such as hemolysis, air-bubble stroke, phrenic nerve palsy, or coronary artery spasm occurred intraoperatively. All patients underwent pulmonary vein isolation (PVI) with VARIPULSE, followed by LAAO with Watchman FLX (21/40) or LACbes (19/40) guided by transesophageal echocardiography (TEE). Post-PFA, LAA ridge thickness increased significantly by 1.21±0.50 mm ( P <0.001) ,30.45±12.69%. At 90-day follow-up, complete sealing (0 mm peri-device leak) was achieved in 100% of patients, with no device-related thrombus (DRT) or embolization observed. Conclusion: Combined PFA and LAAO was feasible with high implant success, low periprocedural complication rates, and favorable outcomes through 90 days. This integrated approach offers a promising “one-stop” strategy for patients with AF requiring rhythm control and stroke prevention. we observed a mean 30.45% increase in LAA ridge thickness immediately following PFA. This study provides preliminary anatomical evidence for postoperative structural changes after VARIPULSE PFA.

Discussion

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Cite This Study

Li et al. (2026) conducted a cohort in Atrial fibrillation (n=40). VARIPULSE pulsed field ablation combined with left atrial appendage occlusion (Watchman FLX or LACbes) vs. Pre-ablation baseline (single-arm study) was evaluated on Presence of residual shunt (peri-device leak) of the left atrial appendage occluder at 90 days, alongside acute change in LAA ridge thickness (MD 1.21 mm, 95% CI 0.96-1.47, p=<0.001). Combined VARIPULSE pulsed field ablation and LAAO increased LAA ridge thickness by 1.21 mm (30.45%, P<0.001) while achieving 100% complete sealing (0% peri-device leak) at 90 days.

synapsesocial.com/papers/6ae28f3bcbadf70daf6c4436 https://doi.org/10.21203/rs.3.rs-10987861/v1

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Left Atrial Ridge Edema After VARIPULSE pulsed field ablation: Correlation With Early Peri-device leak

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Left Atrial Ridge Edema After VARIPULSE pulsed field ablation: Correlation With Early Peri-device leak

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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