Chronic performance of an active fixation coronary sinus lead

Area of Science:

• Cardiology
• Medical Devices
• Heart Failure Management

Background:

• Cardiac resynchronization therapy (CRT) improves outcomes in heart failure patients.
• Optimal left ventricular (LV) lead placement is crucial for CRT efficacy.
• Challenges in LV lead placement include venous anatomy, phrenic nerve stimulation, and lead dislodgement.

Purpose of the Study:

• To evaluate the safety and effectiveness of the Medtronic StarFix active fixation LV lead.
• To assess implant success, lead performance, and adverse events associated with the lead.

Main Methods:

• A multicenter study enrolled 441 patients meeting standard CRT criteria.
• Patients were followed for a mean of 23 months.
• Implant data, CRT success, LV lead performance, and clinical outcomes were prospectively evaluated.

Main Results:

• The lead demonstrated stable low stimulation thresholds (1.3 ± 1 V) and excellent sensing.
• Successful nonanterior lead placement was achieved in 96.3% of cases.
• Low rates of phrenic nerve stimulation (2.5%) and lead dislodgement (0.7%) were observed.

Conclusions:

• The Medtronic StarFix (4195) active fixation LV lead is safe and highly effective.
• The lead provides expanded lead placement options.
• The device exhibits a remarkably low rate of lead dislodgement.