Five-Year RESCUE Trial Data Evaluate Medtronic's Valiant Captivia Device in Blunt Thoracic Aortic Injury

 

January 30, 2019—Medtronic announced new data supporting the long-term durability, safety, and efficacy of its Valiant Captivia thoracic stent graft system for the treatment of blunt thoracic aortic injury (BTAI). Himanshu J. Patel, MD, presented the findings at the Society of Thoracic Surgeons' 55th annual meeting held January 27–29 in San Diego, California.

The 5-year dataset from the RESCUE trial reports the clinical performance of the Valiant thoracic stent graft with the Captivia delivery system on high-risk cohort of patients with aortic transections undergoing thoracic endovascular aortic repair (TEVAR).

The RESCUE study is a prospective, multicenter, nonrandomized, descriptive study that evaluated a total of 50 patients with BTAI of the descending thoracic aorta.

Patients enrolled in the study had a mean injury severity score (ISS) of 38.4 ± 14.4 and 70% (35/50) of BTAI extent was grade III or higher, including one grade IV free rupture, indicative of this extremely high-risk patient cohort. The extent of arch repair required full (40%; 20/50) or partial (18%; 9/50) left subclavian artery coverage. Of the 31 patients available at 5 years, 90.3% (28/31) received clinical follow-up, while 67.7% (21/31) received follow-up imaging.

As noted by Medtronic, data highlights at 5-year follow-up include:

  • Kaplan-Meier freedom from all-cause mortality was 85.2%
  • No stroke or spinal cord ischemia observed
  • 100% freedom from type I or III endoleaks
  • Kaplan-Meier freedom from secondary procedures of 90.6%
  • 100% freedom from retrograde type A dissections, conversions to open repair, or aortic perforations
  • 100% complete exclusion of the traumatic injury maintained
  • No instances of stent graft kinking, fracture, loss of patency, or migration

Dr. Patel stated in the company's announcement, “These data from the RESCUE trial demonstrate that TEVAR with Valiant Captivia continues to be a valuable, safe, and less-invasive alternative to open surgery for patients facing life-threatening aortic injury of BTAI, especially in the setting of critical multisystem injuries. This is the first 5-year industry-issued dataset ever disseminated. The outcomes demonstrate Valiant Captivia to be a safe and durable therapy for high-risk BTAI patients.”

 

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