Zingarini study

Zingarini et al. (2021)

Permanent His bundle pacing using a new tridimensional delivery sheath and a standard active fixation pacing lead: The telescopic technique

Zingarini G et al., Journal of Cardiovascular Electrophysiology, January 2021.
doi: 10.1111/jce.14869

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Introductory Summary

Study Objective

  • To describe the initial experience of permanent His-bundle pacing (HBP) performed with a hybrid telescopic technique, using the newly released Selectra 3D sheath1 and the standard, stylet-driven pacing lead Solia S 601 in combination

Study Design and Characteristics

  • Single-center study
  • 17 consecutive patients with bradycardia indication enrolled from April to August 2020 at the University Hospital of Perugia, Italy
  • Follow-ups scheduled at 1, 6, and 12 months after implantation2

Key Result 1

Zinarini Study Key Result1

Key Result 2

Zinarini Study Key Result 2

Key Result 2

Zinarini Study Key Result 3

Clinical Relevance

  • This study report describes the first experience of permanent HBP performed with a new, specific delivery sheath (Selectra 3D)1 and a stylet-driven pacing lead with an extendable-retractable active screw (Solia S 60).1
  • The early results of this study show that HBP performed with these new tools is feasible, safe and achieves clinically acceptable electric performance both at implantation and at 1 month after implantation.3
Study Objective
  • To describe the initial experience of permanent His-bundle pacing (HBP) performed with a hybrid telescopic technique, using the newly released Selectra 3D sheath1 and the standard, stylet-driven pacing lead Solia S 601 in combination
Clinical Sites
  • University Hospital of Perugia, Italy
Sample Size
  • N = 17
Main Inclusion Criteria
  • Consecutive patients over 18 years old scheduled for permanent pacing to treat bradycardia conditions according to guidelines
Main Exclusion Criteria
  • Candidates for cardiac resynchronization therapy were excluded.
Products
  • Selectra 3D sheath1 and the standard, stylet-driven pacing lead Solia S 601 in combination

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Publication
Zingarini Study Leaflet

1 BIOTRONIK, Berlin, Germany
2 At date of publication, the study was ongoing.
3 Partially extracted from the conclusion by Zingarini et al. (2021).
4 One patient showed only myocardial capture at follow-up. Lead revision was not performed due to stable myocardial capture threshold.