Lower-Profile Graft for TEVAR Demonstrates Safety, Device Success Out to 1 Year
A lower-profile graft
device for thoracic endovascular aortic repair (TEVAR) appears to provide at
least comparable procedural safety and freedom from major adverse events
compared with earlier iterations, suggesting a potential for wider
applicability of the procedure in patients with smaller access vessels,
according to a study published online August 1, 2015, ahead of print in
the Journal of Vascular Surgery.
For the study, Karl A. Illig, MD, of the University of South Florida Morsani College of Medicine (Tampa, FL), and colleagues looked at 110 patients (mean age 72 years; 41.8% women) who received the Zenith Alpha thoracic endovascular graft (Cook Medical) between March 2010 and January 2013 at 23 centers in Europe, Japan, and the United States.
The majority of patients (82%) were enrolled for aneurysms (mean diameter 61 mm), and the rest were enrolled for penetrating ulcers. The primary anatomical criteria for TEVAR were a proximal neck seal zone ≥ 20 mm, an aortic arch radius ≥ 20 mm, and a neck diameter of 15 to 42 mm.
Technical success was achieved in 98%, with 36% of cases done percutaneously. Within 30 days, there were no reported deaths, aortic ruptures, or conversions to open repair. The 30-day freedom from major adverse event rate (primary safety endpoint) was 96.4%, meeting the performance goal of 80.6% (P < .001).
Two patients experienced procedure-related perioperative strokes. Of these, 1 was severe and the patient died 253 days later, the only death within 1 year judged to be related to thoracic aneurysm. This resulted in a 99% rate of freedom from thoracoabdominal aneurysm-related mortality and 95% survival at 1 year.
Also at 1 year, freedom from MI and renal failure were both 97%, freedom from stroke was 95%, and freedom from paraplegia or paralysis was 100%.
Device success at 12 months (primary efficacy endpoint) was 95.5%, meeting the performance goal of 80.7% (P < .001).
Minimum Seal Length Important
Although no patient experienced a proximal type I endoleak, 4 had distal type I endoleak at 1 or more time points within the first year. Graft undersizing and inadequate length of seal zones were considered contributing factors.
“We would like to emphasize that to ensure long-term success, achieving and maintaining a minimum seal length of 20 mm both proximally and distally is essential,” the study authors write. “This can be best assured through careful planning and sizing of the device based on the length of the greater curve of the aneurysm as well as careful device placement and evaluation of [device deployment] completion imaging during the procedure.”
According to Dr. Illig and colleagues, the original Zenith device used introducer sheaths measuring 20 F to 22 F (7.7 mm to 8.5 mm in outer diameters). The newer device is inserted via a lower-profile hydrophilic sheath measuring 16 F, 18 F, or 20 F (6.0 mm, 7.1 mm, or 7.7 mm in outer diameter, respectively). They conclude that the lower-profile device “in many ways performs better than the previous device.”
They add that it “seems intuitive that a smaller hole in the access vessel, less trauma to the iliac vessels, and a lower incidence or shorter duration of obstruction to lower extremity flow during the procedure will yield better overall outcomes.” Based on the current study, the study authors say, “outcomes appear promising and suggest expanded TEVAR applicability, including its use in women and patients with a smaller stature.”
Source:
Illig
KA, Ohki T, Hughes GC, et al. One-year outcomes from the international multicenter
study of the Zenith Alpha thoracic endovascular graft for thoracic endovascular
repair. J Vasc Surg. 2015;Epub ahead of print.
Disclosures:
- The study was sponsored by Cook Medical.
- Dr. Illig reports no relevant conflicts of interest.
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L.A. McKeown is a Senior Medical Journalist for TCTMD, the Section Editor of CV Team Forum, and Senior Medical…
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