Kushida CA; Nichols DA; Holmes TH; Quan SF; Walsh JK; Gottlieb DJ; Simon RD; Guilleminault C; White DP; Goodwin JL; Schweitzer PK; Leary EB; Hyde PR; Hirshkowitz M; Green S; McEvoy LK; Chan C; Gevins A; Kay GG; Bloch DA; Crabtree T; Demen WC. Effects of continuous positive airway pressure on neurocognitive function in obstructive sleep apnea patients: the Apnea Positive Pressure Long-term Efficacy Study (APPLES). SLEEP 2012;35(12):1593-1602.

Stent-graft migration among patients treated in the AneuRx clinical trial appears to be largely related to low initial deployment of the device, below the renal arteries, and short proximal fixation length. Significant variation in migration rate among clinical sites highlights the importance of the technical aspects of stent-graft deployment. Advances in intraoperative imaging and deployment techniques that have been made since completion of the clinical trial facilitate precision of device placement below the renal arteries and should increase proximal fixation length. Whether this, together with increased iliac fixation length, will result in lower risk for migration remains to be determined in long-term follow-up studies.

Based on the PTA performance efficacy rate of 33% derived from industry clinical trial data and the medical literature, and the requirement that the bare nitinol stent 12-month efficacy performance goal be set to equal twice this rate, the patency efficacy goal equals 66%. Additional information is provided on safety and other reporting standards and stent integrity evaluation for bare metal stents.

Endovascular management of abdominal aortic aneurysms with the AneuRx stent graft has markedly reduced the risk of aneurysm rupture while eliminating the need for open aneurysm surgery in 98% of patients at 1 year and 93% of patients at 3 years. The device was effective in preventing aneurysm rupture in 99.5% of patients over a 3-year period. The overall patient survival rate was 93% at 1 year and 86% at 3 years.