Table 1.
Summary of potential benefits and risk of newly designed IS-4/DF-4 connectors and leads
| Potential benefits | Potential risks |
|---|---|
| Treatment related | |
| • Shorter and more convenient implantation procedure | |
| • Enables multipolar P/S leads (e.g. for LV pacing) | |
| Safety related | |
| • Reduced risk of lead-to-port mismatch | • Spring contacts (instead of set screws) may be prone to connection problems |
| • Reduced risk of unset set screws | • Complex connector design may give rise to sealing failures |
| • Reduced risk of abrasion | • DF-4 connector does not allow additional pace/sense leads in case of sensing problems (only by use of special adaptor, not available yet) |
| • New set of seals at device replacement | • DF-4 connector does not allow additional shock lead (e.g. subcutaneous array) in case of elevated defibrillation threshold (only by use of a special adaptor, not available yet) |
| • Requires specially-designed cables for intra-operative testing. Higher risk of incompatibility in case of device replacement | |
| • Inability to add an additional shock or pace/sense lead without an adaptor | |
| Patient-related | |
| • Less material in the device pocket | |
| • Reduced size of device header |