Table 2.
Type of device-related complications in the S-ICD and TV-ICD
| S-ICD (N = 36) | TV-ICD (N = 49) | |
|---|---|---|
| Infection, n (%) | 4 (11.1) | 8 (16.3) |
| Pocket/pulse generator | 3 | 3 |
| Lead | 1a | 5a |
| Bleeding, n (%) | 8 (22.2) | 2 (4.1) |
| Thrombotic event, n (%) | 1 (2.8) | 2 (4.1)a |
| Pneumothorax, n (%) | 0 | 4 (8.2)a |
| Lead perforation, n (%) | 0 | 2 (4.1)a |
| Tamponade, n (%) | 0 | 2 (4.1)a |
| Lead repositioning, n (%) | 2 (5.6) | 7 (14.3)a |
| DFT failure | 1 | 0 |
| Lead dislocation | 1a | 5 |
| Lead dysfunction | 0 | 2b |
| Other lead or device complications, n (%) | 21 (58.3) | 22 (44.9) |
| Lead replacement, n (%) | 3 (8.3)a | 9 (18.4)a |
| Lead dysfunction | 0 | 7b |
| Lead dislocation | 2c | 1 |
| Lead perforation | 0 | 1 |
| Inappropriate therapy | 1 | 0 |
| Device malfunction, n (%) | 4 (11.1) | 6 (12.2) |
| Early battery depletion | 3 | 2 |
| Interrogation problem | 1 | 0 |
| Long charging time | 0 | 1 |
| Automatic ICD reset | 0 | 1 |
| Other device malfunction | 0 | 2d |
| Sensing issues, n (%) | 4 (11.1)a,c | 0 |
| Pacing indication, n (%) | 5 (13.9) | 1 (2.0)c |
| Implantation failure, n (%) | 0 | 3 (6.1)a,e |
| DFT failure with subsequent action, n (%) | 3 (8.3)a | 0 |
| Pain or discomfort, n (%) | 2 (5.6)b,c | 3 (6.1) |
DFT, defibrillator threshold testing, ICD, implantable cardioverter-defibrillator, S-ICD, subcutaneous ICD, TV-ICD, transvenous ICD.
Device-related complication that are combined in the endpoint lead-related complications: 1/4 sensing issues in the S-ICD group was a reduced RV sensing of the RV lead (crossover in S-ICD group); 1/3 DFT failure with subsequent action was included as this one was amongst others related to incorrect lead position; one lead repositioning after DFT failure was not included in this combined endpoint as DFT continued to fail after lead repositioning and was therefore not seen as related to the lead; 1/3 implant failures in the TV-ICD group was included in the lead-related endpoint as in this patient RV lead positioning was impossible despite multiple attempts.
Four patients with a lead dysfunction had an increased threshold of which two had also an increased impedance, two patients had an undersensing of the RV lead and three patients had a lead fracture.
Crossover prior to complication. Only 1/2 patients with a lead dislocation, 1/4 patient with sensing issues, and 1/2 patients with pain or discomfort in the S-ICD group had a crossover to TV-ICD before this complication.
One battery/voltage error, one capacitor charging error.
In 2/3 patients there was no venous access during implantation, in 1/3 patients RV lead positioning was impossible despite multiple attempts.