George H Crossley1, Mauro Biffi2, Ben Johnson3, Albert Lin4, Daniel Gras5, Azlan Hussin6, Allen Cuffio7, Jack L Collier8, Mikhael El-Chami9, Shelby Li10, Keith Holloman10, Derek V Exner11. 1. Vanderbilt Heart and Vascular Institute, Nashville, Tennessee. Electronic address: george.crossley@vanderbilt.edu. 2. Institute of Cardiology, S. Orsola-Malpighi Hospital, Bologna, Italy. 3. Iowa Heart Center, West Demoines, Iowa. 4. Northwestern University, Chicago, Illinois. 5. Nouvelles Cliniques Nantaises, Nantes, France. 6. Institut Jantung Negara, Lumar, Malaysia. 7. Sentara Norfolk General Hospital, Norfolk, Virginia. 8. Oklahoma Heart Hospital, Oklahoma City, Oklahoma. 9. Division of Cardiology-Section of Electrophysiology, Emory University School of Medicine, Atlanta, Georgia. 10. Medtronic, Inc., Minneapolis, Minnesota. 11. University of Calgary, Calgary, Alberta, Canada.
Abstract
BACKGROUND: The Medtronic Attain Performa quadripolar leads provide 16 pacing vectors with steroid on every electrode. This includes a short bipolar configuration between the middle 2 electrodes. OBJECTIVE: A prospective clinical study was conducted to investigate the safety and effectiveness of these new leads in 27 countries. METHODS: Cardiac resynchronization therapy with defibrillator candidates were enrolled (mean age 68 years; 71% men). All implanted subjects were followed at 1, 3, and 6 months postimplant. Pacing capture threshold (PCT) values were measured at each visit. Adverse events were reported upon occurrence. RESULTS: Of 1124 subjects in whom a left ventricular (LV) lead was attempted, 1097 (97.6%) were successfully implanted with an Attain Performa lead. Thirty-six LV lead-related complications were reported (the 6-month LV lead-related complication-free survival rate was 96.9%). Phrenic nerve stimulation (PNS) occurred in 81 subjects (7.2%), with only 3 (0.3%) requiring surgical intervention. At 6 months, the mean PCT at the programmed vector was (1.1 ± 0.8) V and 94.4% of subjects had a PCT of ≤2.5 V. All 16 programming polarities were used in at least 1 patient, and short bipolar configurations were used in 17% of subjects. CONCLUSION: This large multicenter study demonstrated a high success rate for the implantation of Attain Performa quadripolar LV leads with a low complication rate. The PCT was low and stable over time. A low rate of postimplantation PNS was observed, and cases of PNS were readily resolved with reprogramming. Nonstandard vectors were often used for LV pacing.
BACKGROUND: The Medtronic Attain Performa quadripolar leads provide 16 pacing vectors with steroid on every electrode. This includes a short bipolar configuration between the middle 2 electrodes. OBJECTIVE: A prospective clinical study was conducted to investigate the safety and effectiveness of these new leads in 27 countries. METHODS: Cardiac resynchronization therapy with defibrillator candidates were enrolled (mean age 68 years; 71% men). All implanted subjects were followed at 1, 3, and 6 months postimplant. Pacing capture threshold (PCT) values were measured at each visit. Adverse events were reported upon occurrence. RESULTS: Of 1124 subjects in whom a left ventricular (LV) lead was attempted, 1097 (97.6%) were successfully implanted with an Attain Performa lead. Thirty-six LV lead-related complications were reported (the 6-month LV lead-related complication-free survival rate was 96.9%). Phrenic nerve stimulation (PNS) occurred in 81 subjects (7.2%), with only 3 (0.3%) requiring surgical intervention. At 6 months, the mean PCT at the programmed vector was (1.1 ± 0.8) V and 94.4% of subjects had a PCT of ≤2.5 V. All 16 programming polarities were used in at least 1 patient, and short bipolar configurations were used in 17% of subjects. CONCLUSION: This large multicenter study demonstrated a high success rate for the implantation of Attain Performa quadripolar LV leads with a low complication rate. The PCT was low and stable over time. A low rate of postimplantation PNS was observed, and cases of PNS were readily resolved with reprogramming. Nonstandard vectors were often used for LV pacing.
Authors: Jonathan M Behar; Hui Men Selina Chin; Steve Fearn; Julian O M Ormerod; James Gamble; Paul W X Foley; Julian Bostock; Simon Claridge; Tom Jackson; Manav Sohal; Antonios P Antoniadis; Reza Razavi; Tim R Betts; Neil Herring; Christopher Aldo Rinaldi Journal: JACC Clin Electrophysiol Date: 2017-02
Authors: Shasank Rijal; Jonathan Wolfe; Rohit Rattan; Asad Durrani; Andrew D Althouse; Oscar C Marroquin; Sandeep Jain; Suresh Mulukutla; Samir Saba Journal: Indian Pacing Electrophysiol J Date: 2016-10-24
Authors: M Ziacchi; I Diemberger; A Corzani; C Martignani; A Mazzotti; G Massaro; C Valzania; C Rapezzi; G Boriani; M Biffi Journal: Sci Rep Date: 2018-09-05 Impact factor: 4.379