title: Cardiac resynchronization therapy device implantation using a new sensor-based navigation system: results from the first human use study.
abstract: 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.
  
  
  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.
  
  
  BACKGROUND
  URL http://www.clinicaltrials.gov. Unique identifier: NCT01519739.
authors.affiliation: Department of Electrophysiology, Heart Centre, University of Leipzig, Leipzig, Germany.
authors.forename: Sergio
authors.initials: S
authors.lastname: Richter
authors.forename: Michael
authors.initials: M
authors.lastname: Döring
authors.forename: Thomas
authors.initials: T
authors.lastname: Gaspar
authors.forename: Silke
authors.initials: S
authors.lastname: John
authors.forename: Sascha
authors.initials: S
authors.lastname: Rolf
authors.forename: Philipp
authors.initials: P
authors.lastname: Sommer
authors.forename: Gerhard
authors.initials: G
authors.lastname: Hindricks
authors.forename: Christopher
authors.initials: C
authors.lastname: Piorkowski
mesh_terms: D000368:Aged; D058409:Cardiac Resynchronization Therapy Devices; D004567:Electrodes, Implanted; D055590:Electromagnetic Phenomena; D004867:Equipment Design; D004869:Equipment Safety; D005240:Feasibility Studies; D005260:Female; D005471:Fluoroscopy; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome
keywords: cardiac resynchronization therapy; electromagnetic navigation; implantation technique; radiation exposure; tracking