RESCUE Data Published for Medtronic's Valiant Captivia to Treat Blunt Aortic Injury

April 10, 2013—Ali Khoynezhad, MD, et al have published results from the RESCUE trial in the Journal of Vascular Surgery (2013;57:899-905). RESCUE is a prospective, nonrandomized, multicenter trial using the Medtronic Valiant Captivia stent graft (Medtronic, Inc., Minneapolis, MN) to evaluate the early outcomes of patients undergoing thoracic endovascular aortic repair for blunt thoracic aortic injuries.

In November 2012, Medtronic announced that the Valiant Captivia device received expanded approval for thoracic endovascular aortic repair of isolated lesions (excluding dissections) of the descending segment of the thoracic aorta, including transections, from the US Food and Drug Administration.

As detailed in the Journal of Vascular Surgery, RESCUE was conducted at 20 sites in North America. Fifty patients with blunt thoracic aortic injuries were enrolled between April 2010 and January 2012 and will be followed for 5 years. The injuries were classified into categories (grades I-IV) based on severity: intimal tear, intramural hematoma, pseudoaneurysm, or rupture. The primary endpoint was 30-day all-cause mortality. Secondary endpoints were adverse events occurring within 30 days that were related to the procedure, device, or aorta, and aortic-related mortality. Technical success was measured as successful device delivery and deployment.

In the RESCUE study, 76% (38/50) of patients in the study were male with mean age of 41 ± 17 years. The investigators implanted 51 Medtronic Valiant Captivia thoracic stent grafts and a single Medtronic Talent thoracic stent graft within a median of 1 day after injury (mean, 1.8 ± 4 days).

According to the investigators, 70% (35/50) of aortic injuries were grade III or higher, including one patient with free rupture. The mean injury severity score was 38 ± 14, and 54% percent of stent grafts were ≤ 26 mm (28/52). The left subclavian artery was completely covered in 40% of patients (20/50) and partially covered in 18% of patients (9/50). Four patients underwent subclavian artery revascularization, one at the time of the endograft procedure and three others after developing arm ischemia after the initial endograft procedure. Cerebral spinal fluid was drained in two patients.

The investigators reported that the median procedure time was 91 minutes, and median hospital stay was 12 days. There was 100% successful device delivery and deployment. Four (8%) patients died within 30 days. Nonfatal adverse events within 30 days that were related to the procedure, device, or aorta were experienced by 12% (6/50) of patients. There were no reported nonfatal adverse events related to the device. A single death was conservatively adjudicated as device-, procedure-, and aorta-related because of insufficient information. No patient developed spinal cord injury, and there were no cerebrovascular accidents. However, one patient had an anoxic brain injury after aortic rupture. No patient underwent conversion to open repair or required an endovascular reintervention.

Based on the early outcomes, the RESCUE investigators concluded that the Medtronic Valiant Captivia stent graft appears to be a promising treatment modality for blunt thoracic aortic injuries. They advised that long-term follow-up is necessary to substantiate the effectiveness of thoracic endovascular aortic repair in treatment of blunt thoracic aortic injuries.