The Very Long-Term Durability of TEVAR for Traumatic Aortic Transection Determined by Real-World Evidence

OBJECTIVES: The young age of many aortic transection patients treated with TEVAR requires long term follow-up to determine the durability of the endoprosthesis over a period of time appropriate to the patients’ expected survival. FDA post approval five-year surveillance studies undermined by high rate of patients lost to follow-up, bench testing of graft components limited to ten years, the paucity of long-term outcomes in 2012, prompted a literature search, an ad hoc Real World Evidence summary showing favorable five year TEVAR outcomes, and a case report of a nine year survivor, presented at the 2012 Third Aortic Conference. This abstract reports the results of a search extended to twenty years with results analyzed by ad hoc summing of RWE to realize very long term outcomes of TEVAR for traumatic aortic transection.

METHODS: The author updated the 2011 systematic search and ad hoc summing of TEVAR data to increase the long-term outcomes to twenty years. The iterative process allowed the sample to be refined to explore insights that emerged from the addition of new data. The search found four additional publications with similar data profiles. The new data provided an additional decade of very long-term clinical surveillance of the endograft supported by objective radiologic data of graft integrity and patient-provided health outcome data.

RESULTS: The pooling of the four newer studies added an additional 197 patients with endoleaks in 6 patients, malapposition problems in 2 patients, and successful re-intervention in 3 patients. During long term clinical and radiologic follow-up surveillance to 20 years, no fatal endograft failures occurred.

CONCLUSIONS: The RWE supports a conclusion that TEVAR used for blunt thoracic aortic transection provides a long-term stable and durable repair of the traumatic aortic injury. The long term stable aortic repair constitutes evidence for strategizing a reduction in radiation follow-up studies.