Key result
VIZIGO steerable sheath achieves acute success with ~2% major complications in pediatric and ACHD electrophysiology.
Why the study?
The VIZIGO visualizable steerable sheath is widely used during electrophysiology procedures, but data on its safety and effectiveness in pediatric and adult congenital heart disease (ACHD) patients are limited.
What is the safety and acute procedural effectiveness of using the VIZIGO visualizable steerable sheath during electrophysiology procedures in pediatric and adult congenital heart disease patients?
Cohort (n=62)
No
What is the safety and acute procedural effectiveness of using the VIZIGO visualizable steerable sheath during electrophysiology procedures in pediatric and adult congenital heart disease patients?
This first evaluation of the VIZIGO visualizable steerable sheath in pediatric and ACHD patients demonstrates high acute procedural success (93.2% and 83.3%, respectively) and a low major complication rate (1.6%).
Answers are grounded in this paper and cite their sources.
May support sheath selection in pediatric congenital EP cases; extends adult data but leaves open need for prospective validation.
Background The VIZIGO™ visualizable steerable sheath is widely used during electrophysiology procedures; however, data regarding its use in pediatric and adult congenital heart disease (ACHD) patients are limited. Objective To evaluate the safety and effectiveness of the VIZIGO™ visualizable steerable sheath in pediatric and ACHD patients undergoing electrophysiology procedures. Methods We retrospectively reviewed all electrophysiology procedures performed between September 2018 and December 2023 in which the VIZIGO™ sheath was used in pediatric patients (<21 years) and ACHD patients at a single tertiary referral center. Procedural characteristics, acute procedural success and major complications were analyzed. Results Sixty-two patients were included, comprising 44 pediatric and 18 ACHD patients. Left atrial access using the VIZIGO™ sheath was obtained in 14 procedures (22.6%) through transseptal or trans-baffle puncture. Acute procedural success was achieved in 93.2% of pediatric patients and 83.3% of ACHD patients. One major complication occurred (1.6%), consisting of a pericardial effusion requiring drainage following fluoroscopy-guided transseptal puncture in a pediatric patient. No vascular complications attributable to the sheath, thromboembolic or permanent atrioventricular block occurred. Conclusion This study represents, to our knowledge, the first evaluation of the VIZIGO™ visualizable steerable sheath in pediatric and ACHD patients. High acute procedural success and a low rate of major complications were observed across a broad spectrum of electrophysiology procedures in selected pediatric patients, predominantly larger children and adolescents, and in ACHD patients.
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Bienjonetti-Boudreau et al. (2026) conducted a cohort in Pediatric and adult congenital heart disease (ACHD) undergoing electrophysiology procedures (n=62). VIZIGO visualizable steerable sheath was evaluated on Acute procedural success and major complications. The VIZIGO visualizable steerable sheath achieved acute procedural success in 93.2% of pediatric and 83.3% of ACHD patients with a 1.6% major complication rate.
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