Real-World Clinical Outcomes and Efficiency of a New Steerable Sheath Technology for Radio-Frequency Ablation in Chinese Patients with Atrial Fibrillation

Author(s)

Xie Q1, Zhao Y1, Zhang C1, Chen C2, Yan L2, Chen W3
1Xiangya Hospital of Central South University, Changsha, China, 2Changsha Normin Health Technology Ltd, Changsha, China, 3Normin Health Consulting Ltd, Mississauga, ON, Canada

OBJECTIVES: To assess real-world clinical utility of a steerable sheath (VIZIGO, Biosense Webster, Inc) for radiofrequency ablation (RA) through the comparisons with fixed curve sheath (NaviEase, Synaptic Medical) in Chinese patients with atrial fibrillation (AF).

METHODS: Adult patients who underwent their first RA for AF by the same electrophysiologist from January to November 2021 in a Chinese tertiary care hospital were identified and included. Patients who experienced cardiovascular events within 3 months before ablation were excluded. Multivariate generalized linear regression analyses were performed to assess the association between the sheath type (VIZIGO vs. NaviEase) and the main outcome measures related to clinical utility after adjusting for patient characteristics and surgery types.

RESULTS: Fourteen patients using VIZIGO sheath and 34 patients using NaviEase sheath for RA were included in the data analysis. The VIZIGO sheath group was associated with significantly higher proportions of left atrium with diameter >45 mm (21.4% vs. 3.0%, P=0.039) or volume >=145 ml (64.3% vs. 23.5%, P=0.007) than the NaviEase sheath group. Using VIZIGO sheath for RA was associated with significantly shorter total pulmonary vein isolation (PVI) fluoroscopy time [coefficient -0.859, 95% confidence interval (CI) -1.501 to -0.204, p=0.014] and post-RA hospital length of stay (LOS) (coefficient -0.303, 95% CI -0.608 to -0.048, p=0.018) than using NaviEase sheath in the multivariate generalized regression analyses. According to the patient characteristics of the included patients, the predicted total PVI fluoroscopy time (1.6+/-1.6 minutes vs. 3.9+/-3.8 minutes, p<0.001) and post-RA LOS (2.2+/-0.9 days vs. 2.9+/-1.2 days, p<0.001) were significantly shorter for VIZIGO sheath.

CONCLUSIONS: A steerable sheath was more likely to be used in RA for Chinese AF patients with a larger left atrium. Relative to fixed curve sheath, steerable sheath used for RA could significantly save PVI fluoroscopy time and reduce post-RA LOS in a Chinese hospital setting.

Conference/Value in Health Info

2022-11, ISPOR Europe 2022, Vienna, Austria

Value in Health, Volume 25, Issue 12S (December 2022)

Code

CO53

Topic

Clinical Outcomes, Medical Technologies, Study Approaches

Topic Subcategory

Clinical Outcomes Assessment, Electronic Medical & Health Records, Medical Devices

Disease

SDC: Cardiovascular Disorders (including MI, Stroke, Circulatory), STA: Medical Devices, STA: Surgery

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