At the International Congress in Phoenix, Dr Mark Farber, University of North Carolina, discussed the preliminary results of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms (VALOR) trial. This particular talk focused on one of the three arms of the trial, namely the high-risk, non-surgical group.
The objective of the study was to examine the safety and efficacy of the Medtronic Vascular Talent stent graft system for patients with thoracic aortic disease who were at high-risk from open surgery (SVS3) and/or non-surgical candidates not associated with SVS scoring. Inclusion criteria included proximal and distal aortic non-aneurysmal neck diameter between 18-42mm.
It is a prospective, non-randomized, multi-center study with a primary endpoint of “all cause” mortality at 12 months comparing open surgical repair against minimally invasive endovascular stent treatment using the Talent stent graft system. A total of 137 patients were recruited to this arm, with 75% of those presenting with aneurysmal disease.
The median diameter aneurysm treated was 54mm, with a median aneurysm length of 102mm. Only one patient required conversion resulting in a deployment success rate of 98%. Twenty four patients (18%) had previously undergone abdominal aortic aneurysm repair. The mean duration of the procedure was 2.9 hours and the hospital stay 9.9 days.
The results showed that 30-day mortality was 7.3% (10 patients), one patient had paraplegia (<1%) and 7.3% (10 patients) of patients suffered a stroke. Endoleaks after 30-days were 9% (11/117). At eight months, two patients have had migration >5mm (from one month); however there were no losses in stent graft patency, integrity or evidence of twisting. One patient reported evidence of kinking and one patient had aneurysm enlargement >5mm. Overall there was 75% survival rate at 8 months.
In conclusion, Farber said that the results demonstrate highly favorable preliminary outcomes in a high-risk non surgical population of patients historically managed with watchful waiting. Procedural success was high, whilst operative mortality, incidence of stroke and paraplegia rates were low. “We believe these outcomes are predictive of the ‘real-world’ application of this technology. However, long-term follow-up will be required to demonstrate durability and prevention of thoracic aortic-related mortality.
Final VALOR results should be available in mid-2006, with approval for the Talent system anticipated in late 2006 or early 2007.