John D Hummel1, Mark A Coppess2, Jeffrey S Osborn3, Raymond Yee4, Jeffrey W H Fung5, Ralph Augostini1, Shelby Li6, Douglas Hine6, Jagmeet P Singh7. 1. Ohio State University, Columbus, Ohio. 2. Stern Cardiovascular Center, Germantown, Tennessee. 3. Intermountain Medical Center, Murray, Utah. 4. London Health Sciences Centre, London, Ontario, Canada. 5. Chinese University of Hong Kong, Shatin, Hong Kong. 6. Medtronic, Mounds View, Minnesota. 7. Massachusetts General Hospital, Boston, Massachusetts.
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.
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.