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Year

  • 2016 (1)

Author

  • Barr, Craig S. (1)
  • Boersma, Lucas (1)
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Search Results for all work with filters:

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Article

The learning curve associated with the introduction of the subcutaneous implantable defibrillator

by Reinoud Knops; Tom F. Brouwer; Craig S. Barr; Dominic A. Theuns; Lucas Boersma; Raul Weiss; Petr Neuzil; Marcoen Scholten; Pier D. Lambiase; Angel Rodrigo Leon; Margaret Hood; Paul W. Jones; Nicholas Wold; Andrew A Grace; Louise R. A. Olde Nordkamp Nordkamp; Martin C. Burke

2016

Subjects
  • Health Sciences, Medicine and Surgery
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Abstract:Close

Aims: The subcutaneous implantable cardioverter defibrillator (S-ICD) was introduced to overcome complications related to transvenous leads. Adoption of the S-ICD requires implanters to learn a new implantation technique. The aim of this study was to assess the learning curve for S-ICD implanters with respect to implant-related complications, procedure time, and inappropriate shocks (IASs). Methods and results: In a pooled cohort from two clinical S-ICD databases, the IDE Trial and the EFFORTLESS Registry, complications, IASs at 180 days follow-up and implant procedure duration were assessed. Patients were grouped in quartiles based on experience of the implanter and Kaplan-Meier estimates of complication and IAS rates were calculated. A total of 882 patients implanted in 61 centres by 107 implanters with a median of 4 implants (IQR 1,8) were analysed. There were a total of 59 patients with complications and 48 patients with IAS. The complication rate decreased significantly from 9.8% in Quartile 1 (least experience) to 5.4% in Quartile 4 (most experience) (P = 0.02) and non-significantly for IAS from 7.9 to 4.8% (P = 0.10). Multivariable analysis demonstrated a hazard ratio of 0.78 (P = 0.045) for complications and 1.01 (P = 0.958) for IAS. Dual-zone programming increased with experience of the individual implanter (P < 0.001), which reduced IAS significantly in the multivariable model (HR 0.44, P = 0.01). Procedure time decreased from 75 to 65 min (P < 0.001). The complication rate and procedure time stabilized after Quartile 2 ( > 13 implants). Conclusion: There is a short and significant learning curve associated with physicians adopting the S-ICD. Performance stabilizes after 13 implants.
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