Crossley George H, Biffi Mauro, Johnson Ben, Lin Albert, Gras Daniel, Hussin Azlan, Cuffio Allen, Collier Jack L, El-Chami Mikhael, Li Shelby, Holloman Keith, Exner Derek V
Vanderbilt Heart and Vascular Institute, Nashville, Tennessee.
Institute of Cardiology, S. Orsola-Malpighi Hospital, Bologna, Italy.
Heart Rhythm. 2015 Apr;12(4):751-8. doi: 10.1016/j.hrthm.2014.12.019. Epub 2014 Dec 19.
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.
A prospective clinical study was conducted to investigate the safety and effectiveness of these new leads in 27 countries.
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.
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.
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.
美敦力Attain Performa四极导线在每个电极上都带有类固醇，可提供16种起搏向量。这包括中间两个电极之间的短双极配置。
在27个国家进行了一项前瞻性临床研究，以调查这些新型导线的安全性和有效性。
纳入符合心脏再同步化治疗除颤器标准的患者（平均年龄68岁；71%为男性）。所有植入患者在植入后1、3和6个月进行随访。每次随访时测量起搏夺获阈值（PCT）值。不良事件发生时进行报告。
在1124例尝试植入左心室（LV）导线的患者中，1097例（97.6%）成功植入了Attain Performa导线。报告了36例与LV导线相关的并发症（6个月时与LV导线相关的无并发症生存率为96.9%）。81例患者（7.2%）发生膈神经刺激（PNS），其中仅3例（0.3%）需要手术干预。6个月时，程控向量处的平均PCT为（1.1±0.8）V，94.4%的患者PCT≤2.5V。所有16种程控极性至少在1例患者中使用过，17%的患者使用了短双极配置。
这项大型多中心研究表明，Attain Performa四极LV导线植入成功率高，并发症发生率低。PCT较低且随时间稳定。观察到植入后PNS发生率较低，通过重新程控可轻松解决PNS病例。非标准向量常用于LV起搏。
