Cardiac resynchronization therapy device implantation using a new sensor-based navigation system: results from the first human use study.

BACKGROUND

Cardiac resynchronization therapy (CRT) device implantation can be challenging, time consuming, and fluoroscopy intense. To facilitate left ventricular lead placement, a novel sensor-based electromagnetic tracking system (MediGuide Technology [MGT], St. Jude Medical) has been developed. We report the results of the First Human Use study evaluating the feasibility, safety, and performance of a novel CRT implantation approach using electromagnetic trackable operation equipment.

METHODS AND RESULTS

Fifteen consecutive patients (66±8 years, 53% male) with an established indication for CRT were implanted using the new tracking technology. Demographics, anatomical information, detailed fluoroscopy need, procedure time, and adverse events were collected. Patients were followed up for 4 weeks after implantation. The CRT system was successfully implanted with a lateral or posterolateral left ventricular lead position in all patients. The total procedure time was 116±43 minutes, the median total fluoroscopy time (skin to skin) was 5.2 (Q1-Q3, 3.0-8.4) minutes, and the median fluoroscopy time for left ventricular lead deployment (coronary sinus [CS] cannulation to withdrawal of CS sheath) measured 2.6 (Q1-Q3, 1.6-5.6) minutes. There were no severe complications that required an acute intervention or reoperation during the perioperative and postoperative periods.

CONCLUSIONS

Use of the MGT tracking technology allows for safe and successful CRT implantation with the potential for reduced fluoroscopy time. Future randomized studies are needed to validate these data.

CLINICAL TRIAL REGISTRATION

URL http://www.clinicaltrials.gov. Unique identifier: NCT01519739.