Abstract
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.
Original language | English |
---|---|
Pages (from-to) | 1010-1015 |
Number of pages | 6 |
Journal | Europace : European pacing, arrhythmias, and cardiac electrophysiology |
Volume | 18 |
Issue number | 7 |
DOIs | |
Publication status | Published - Jul 2016 |
Keywords
- Adult
- Aged
- Cardiac Surgical Procedures/education
- Databases, Factual
- Defibrillators, Implantable
- Electric Countershock
- Female
- Follow-Up Studies
- Humans
- Kaplan-Meier Estimate
- Learning Curve
- Male
- Middle Aged
- Multivariate Analysis
- Proportional Hazards Models
- Prosthesis Implantation/education
- Registries
- Risk Factors
- Treatment Outcome