Durable outcomes of thoracic endovascular aortic repair with Zenith TX1 and TX2 devices

J Vasc Surg. 2017 May;65(5):1287-1296. doi: 10.1016/j.jvs.2016.11.029. Epub 2017 Feb 16.

Abstract

Objective: Long-term data regarding the safety and durability of thoracic endovascular aortic repair (TEVAR) are limited. The study objective was to evaluate the long-term outcomes of TEVAR in high-risk patients with descending thoracic aortic pathology.

Methods: High-risk patients were treated with thoracic endografts (2001-2011) under a prospective, physician-sponsored, investigational device exemption trial. Three-dimensional reconstructions and measurements were performed on computed tomography scans acquired before discharge, at 1, 6, and 12 months, and then yearly thereafter.

Results: The study included 200 patients, of whom 171 were treated for thoracic aneurysm, 28 for chronic dissection, and 1 for aortobronchial fistula. Patients were monitored for an average of 4.8 ± 3.3 years, and 93 (46.5%) were monitored for >5 years. Operative mortality was 6.5%. Survival at 30 days and at 1, 5, and 9 years was 94.0%, 85.8%, 55.6%, and 31.4%, and freedom from aneurysm-related death was 94.0%, 92.4%, 91.7%, 91.7%, respectively. Sixty-one endoleaks occurred in 54 patients (28%). Sixty-seven reinterventions were performed in 50 patients. Overall freedom from reintervention at 30 days, 1, 5, and 9 years was 87.9%, 82.9%, 75.5%, and 64.0%, respectively. Forty-seven reinterventions (70%) were thoracic aneurysm-related, 35 (74%) of which were endovascular procedures. Thirty of these were to correct endoleaks at a median of 1.4 years (interquartile range, 0.2-5.0 years).

Conclusions: TEVAR is durable and associated with high long-term aneurysm-related survival. Long-term imaging follow-up remains critical to identify endoleaks or rare device durability issues, most of which can be monitored or managed with endovascular therapies.

Publication types

  • Clinical Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Aged
  • Aorta, Thoracic / diagnostic imaging
  • Aorta, Thoracic / surgery*
  • Aortic Diseases / diagnostic imaging
  • Aortic Diseases / mortality
  • Aortic Diseases / surgery*
  • Aortography / methods
  • Blood Vessel Prosthesis Implantation / adverse effects
  • Blood Vessel Prosthesis Implantation / instrumentation*
  • Blood Vessel Prosthesis Implantation / mortality
  • Blood Vessel Prosthesis*
  • Computed Tomography Angiography
  • Disease-Free Survival
  • Endovascular Procedures / adverse effects
  • Endovascular Procedures / instrumentation*
  • Endovascular Procedures / mortality
  • Female
  • Humans
  • Imaging, Three-Dimensional
  • Kaplan-Meier Estimate
  • Male
  • Ohio
  • Postoperative Complications / etiology
  • Postoperative Complications / mortality
  • Postoperative Complications / therapy
  • Prospective Studies
  • Prosthesis Design
  • Radiographic Image Interpretation, Computer-Assisted
  • Retreatment
  • Risk Factors
  • Stents*
  • Time Factors
  • Treatment Outcome