Investigators from ENRG wanted to know whether outcomes would remain consistently positive after the device was approved and was being used in clinical practice. "We asked this question because there have been instances where an approved device did not perform as well in a real-world setting as it had in a clinical trial leading up to its approval," Ringer says.
In the case of the flow-diverting Pipeline, Ringer continues, the device lived up to expectations. "We tracked the outcomes of patients who had the Pipeline used for aneurysm treatment in standard practice, outside the confines of a study, and we were able to show that the outcomes in fact were quite good."
The study tracked the outcomes of 56 patients treated at the seven centers. Clinicians used an average of two Pipeline devices to treat each aneurysm, and they used coils as well in treating 25 percent of the aneurysms. Of the 19 patients who had a three-month follow-up angiogram, 68 percent had complete, successful occlusion of their aneurysm. The study also reported, in its "most surprising finding," a major complication rate, resulting in permanent disability or death, of 8.5 percent. Four patients with giant aneurysms suffered fatal hemorrhages following their procedure.
"While any adverse outcome is cause for regret, we recognize that these patients had high-risk aneurysms, and other treatment options or observation may have been even riskier," Ringer says. "We will continue watching outcomes as the device bec
|Contact: Cindy Starr|
University of Cincinnati Academic Health Center