Real-World Assessment of Acute Left Ventricular Lead Implant Success and Complication Rates: Results from the Attain Success Clinical Trial

Pacing Clin Electrophysiol. 2016 Nov;39(11):1246-1253. doi: 10.1111/pace.12939. Epub 2016 Oct 4.

Abstract

Background: Left ventricular lead (LVL) implant success rates have historically ranged between 70.5% and 95.5%. To date, there are few large studies that evaluate LVL implant success utilizing a single family of delivery catheters and leads. The Attain Success study was a prospective nonrandomized multicenter global study with the main objectives of assessing single-system LVL implant success and complication rates.

Methods: Patients undergoing cardiac resynchronization therapy implantation were eligible for enrollment. There was no prespecified level of experience for investigator participation. LVL implant success and complication rates were assessed though 3 months of follow-up.

Results: A total of 2,014 patients (69.1 ± 12.0 years, 71% male and 38% atrial fibrillation) were enrolled from 114 centers with a follow-up of 3.5 ± 2.1 months. Coronary sinus cannulation success rate was 96.4% with Attain Family delivery catheters. Implant success rate for Attain Family leads using Attain Family catheters was 94.0%; overall LVL implant success rate was 97.1%. Median procedure time was 4 minutes for cannulation and 9 minutes for LVL placement. Median fluoroscopy time was 17 minutes and median contrast used was 25 cc. There were 55 catheter or LVL-related complications in 53 subjects; the majority were LVL dislodgements (34, 1.7%) and extracardiac stimulation (11, 0.5%). The Kaplan-Meier estimate of the 3-month complication probability was 2.6%.

Conclusion: This study represents the largest prospective evaluation of LVL implantation to date, revealing a high LVL implant success rate and low complication rate using a single family of leads and delivery catheters.

Keywords: cardiac resynchronization; coronary sinus; left ventricular lead.

MeSH terms

  • Aged
  • Cardiac Resynchronization Therapy*
  • Female
  • Follow-Up Studies
  • Heart Ventricles
  • Humans
  • Male
  • Postoperative Complications
  • Prospective Studies
  • Prostheses and Implants*
  • Treatment Outcome