Postmarket Data Support Cook's Zenith t-Branch Endograft to Treat TAAA
April 17, 2019—An off-the-shelf endograft (Zenith t-Branch, Cook Medical) for the treatment of thoracoabdominal aortic aneurysm (TAAA) provides a safe and straightforward solution for a wide range of patients—including emergency cases—according to findings presented by Martin Austermann, MD, at the Charing Cross Symposium, held April 15–18 in London, United Kingdom.
Dr. Austermann presented the short-term results of a postmarket multicenter observational study evaluating the use of the t-Branch endograft in routine clinical care.
As noted in the Charing Cross Symposium press release, endovascular repair is increasingly being used to treat patients with TAAA, but manufacturing of customized stents can take up to 8 weeks, limiting their use in urgent cases. Cook launched the Zenith t-Branch device in September 2012 as an immediate solution for patients with any type of TAAA. The endograft has four downward-facing cuffs for the renal and visceral arteries and can be further extended at the proximal end with tapered off-the-shelf components, enabling interventionists to accommodate individual patient anatomy. Previous studies have suggested that it is suitable for approximately half of the patients who would otherwise be treated with custom-made endografts.
In the study of the t-Branch device, 80 patients were enrolled at two sites in Germany and one in Sweden between September 2012 and November 2017, of whom 96% were treated for aneurysms and 4% for dissections. Half of the procedures were performed in a staged fashion.
Dr. Austermann reported that the primary outcome was procedure-related mortality and morbidity at 30 days. The technical success rate was 100%. There was one death within 30 days, and there were no ruptures or conversions.
In the Charing Cross Symposium announcement, Dr. Austermann advised that the design of the t-Branch lends it to broad applicability, including urgent cases, and commented, “Planning the procedure is easy and implantation is very safe and straightforward. In emergency cases, the use of t-Branch saves lives.”