Long-term performance of VDD vs. VVI ICD leads: a single-manufacturer analysis based on product performance report
F Gausz, D Fodor, M Miklos, A Benak, D Kranyak, L Saghy, T Szili-Torok, M VamosAbstract
Background
VDD ICDs utilize a single ventricular lead with an integrated floating atrial sensing dipole. Providing reliable atrial sensing, the main advantage of VDD ICDs is the enhanced detection of atrial arrhythmias compared to conventional VVI devices. Developed in the 2000s, the recently used modern VDD leads were first introduced in Europe and in the United States (US) in the early 2010s. While VDD leads can provide more information, they have a more complex design, which potentially carries a higher risk of lead failure over time. Therefore, assessing the long-term performance and reliability of these leads is essential.
Purpose
We aimed to compare the long-term performance of VDD ICD leads with conventional VVI ICD leads by analyzing the most recent product performance report provided by the exclusive manufacturer of VDD ICDs.
Methods
Data from the latest cardiac rhythm management product performance report (1st Edition 2025) of a single manufacturer were extracted. All single-coil, active fixation ICD leads were included with US release dates from 2011 onward. Using available sample sizes, we established representative groups of VVI and VDD ICD leads for each year post-implantation (from 1 to 11 years). Lead survival was evaluated by calculating survival probabilities and odds ratios (OR) for lead failure, with 95% confidence intervals (CI). A p-value of ≤0.05 was considered statistically significant.
Results
The baseline lead number was 42735 in the VDD and 37236 in the VVI group. Except for the 1-year post-implantation data – which showed a higher risk for lead failure in VDD group (OR 1.288, 95% CI 1.046–1.586, p=0.017) – no significant differences in lead performance were observed at any subsequent post-implantation year. At 11 years post-implantation, the survival probability was 92.7% in the VDD and 93.4% in the VVI group. The OR for lead failure was 1.116 (95% CI 0.891–1.397, p=0.339) for the VDD vs. VVI group 11 years after implantation.
Conclusion
The long-term performance of VDD leads proved to be similar to conventional VVI ICD leads, supporting their reliability over extended periods.Graphical abstract