Initial clinical experience with the modified Zenith "Pro-Form" TX2 thoracic endograft

Area of Science:

• Vascular Surgery
• Cardiovascular Devices
• Medical Technology

Background:

• Thoracic aortic diseases pose significant risks.
• Endovascular repair offers a less invasive treatment option.
• New stent-graft devices require rigorous safety and efficacy evaluation.

Purpose of the Study:

• To evaluate the safety and efficacy of the Zenith TX2 thoracic stent-graft with Pro-Form.
• To assess the device's performance in treating various descending thoracic aortic pathologies.
• To investigate stent-graft conformance in challenging aortic anatomies.

Main Methods:

• Prospective study of 27 patients treated with Zenith TX2 stent-graft (March 2009-present).
• Diverse pathologies included aneurysms, dissections, endoleaks, ulcer, and rupture.
• Analysis of proximal landing zone distribution and aortic angulation.

Main Results:

• Successful deployment in all cases with no intraoperative complications or mortality.
• Postoperative morbidity included respiratory failure (1), transient renal failure (3), and post-implantation syndrome (2).
• 100% clinical success at 1 and 6 months, with no type I endoleaks; excellent conformance except in one severely angulated aorta.

Conclusions:

• The Zenith TX2 thoracic stent-graft with Pro-Form is safe and effective for thoracic aortic pathology.
• The device demonstrates excellent conformance, even in anatomically challenging cases.
• Further validation in larger studies with longer follow-up is warranted.