Three-Year STRATO Data Support Cardiatis' MFM Device for TAAA Repair

June 20, 2016—Three-year outcomes from the STRATO trial were published by Claude D. Vaislic, MD, et al online ahead of print in the Journal of Endovascular Therapy (JEVT). STRATO is evaluating the safety and efficacy of the MFM (multilayer flow modulator) device (Cardiatis) for repair of thoracoabdominal aortic aneurysms (TAAAs).

The investigators sought to evaluate midterm outcomes of endovascular repair of type 2 and 3 TAAAs using the MFM device in patients who are unsuitable for open surgery or the use of fenestrated stent grafts. 

As summarized in JEVT, the prospective, multicenter, nonrandomized STRATO trial enrolled 23 patients (mean age, 75.8 years; 19 men) with Crawford type 2 and 3 TAAA (mean diameter, 6.5 cm) who were implanted with the MFM device between April 2010 and February 2011. Outcomes included all-cause mortality and stable aneurysm thrombosis with associated branch vessel patency.

The investigators reported that through 36 months, there were seven deaths (none confirmed as aneurysm related) and no cases of spinal cord injury, device migration or fracture, or respiratory, renal, or peripheral complications. Three patients were lost to follow-up, and two devices were explanted. The device was patent in the 11 remaining patients at 3 years. 

Stable aneurysm thrombosis was achieved in 15 of 20 patients at 12 months, 12 of 13 patients at 24 months, and 10 of 11 patients at 36 months. The rate of branch patency was 96% at 12 months (primary patency), 100% at 24 months, and 97% at 36 months. Nine patients experienced endoleaks (attachment site or device overlap). Nine patients underwent 11 reinterventions (three surgical).

Maximum aneurysm diameter was stable for 18 of 20 patients at 12 months, 11 of 13 patients at 24 months, and 9 of 11 patients at 36 months.

For 10 patients who underwent CT imaging at 36 months, the mean ratio of aneurysm flow volume to total volume had decreased by 83%; the mean ratio of thrombus volume to total volume increased by 159%.

Through 3 years, endovascular repair with the MFM device appears to be safe and effective while successfully maintaining branch vessel patency, concluded the investigators in JEVT.