Final operative and midterm results of the European experience in the RELAY Endovascular Registry for Thoracic Disease (RESTORE) study

Abstract

Purpose: Thoracic endovascular aortic repair is increasingly becoming the standard treatment of many thoracic aortic pathologies. New reliable and accurate stent grafts are emerging to widen the endovascular treatment options. We report the results of RELAY (Bolton Medical, Barcelona, Spain) in the large RELAY Endovascular Registry for Thoracic Disease (RESTORE) European registry.

Methods: RESTORE is a multicenter, prospective European registry involving 22 centers in seven European countries. The RELAY device is composed of a stent graft (self-expanding nitinol stents and a polyester vascular graft) and a delivery device specifically designed for the thoracic aorta. Included were acute and elective patients presenting with a variety of pathologies (aneurysms, dissections, ulcerations, intramural hematomas, pseudoaneurysms) and lesions in different aortic and anatomic locations (ascending, arch, descending and thoracoabdominal).

Results: The registry enrolled 304 patients from April 2005 to January 2009. All-cause mortality at 30 days was 7.2%. Freedom from all cause mortality and freedom from device- and procedure-related mortality at 2 years were 78.5% and 95.9%, respectively. An average of 1.26 graft components were used per patient, with a technical success of 97.7% irrespective of the etiology. Early endoleak rate was 4.6%. Perioperatively, stroke and paraplegia were registered in 1.6% and 2.0%, respectively.

Conclusions: The results of RESTORE support the safety of thoracic endovascular aortic repair with the RELAY stent graft, even in acute and complicated situations. The device was highly efficient in angulated aortic anatomies, with acceptable mortality and a low rate of neurologic complications.