In a Bolton Medical sponsored event, Piergiorgio Cao, Rome, Italy, and Toru Kuratani, Osaka, Japan, both presented their experience with the company’s Thoracic Arch Branched Device. Kuratani also presented his experience at the CX Complex Edited Live Cases and Case Reports.

Cao spoke to delegates about complex cases in which deployment of the Thoracic Arch Branch device was successful using single- and double-branches. Cao showed 3D CT images that indicated the successful use of the device in single branches in five cases (including ascending and descending aorta dilatation, arch aneurysm, pseudoaneurym, and endoleak amongst other comorbidities such as diabetes and hypertension). He commented that final angiograms of these cases were good.

With the double-branch device, Cao spoke about one patient with a thoracic aortic aneurysm involving the left subclavian artery with no proximal neck posterior to the left circumflex coronary artery (the left circumflex coronary artery and the iliac artery were also very close together). He reported that this was successful but the patient had a type 2 endoleak, which was due to be treated in the coming weeks.

Referring his experience with the device, Kuratani reviewed 3,015 cases of aortic aneurysms. Of these, 2,383 had been treated with a stent graft. He also showed a video to delegates of his team performing a debranching thoracic endovascular aneurysm repair with the Bolton Medical device.

The arch branch technology (based on the Relay non-bare stent plus platform, intended for zone 0 deployments), according to Bolton Medical, incorporates a proximal clasping mechanism intended for repositioning and a V-patch inner sheath for expansion and optimal alignment.

The (single and double) branch graft is expected to be examined via data collected by the company, from further clinical experience and a trial of the branched devices from centres preforming thoracic abdominal aneurysm repair. In phase I of this analysis, the single branch device will be tested in five institutions in six cases. In phase II, the double branch device will be assessed in six cases across six institutions.

Heinz Günther Jakob (Essen, Germany) told CX delegates about a new three-zone aortic arch hybrid prosthesis, which has been designed to reduce ischaemic times by 50%. Jakob reported that the three-stage hybrid graft was created with the aim of reducing the rate of complications seen with the E-vita open hybrid prosthesis (Jotec) in some patients.

He said that it consists of a “descending aortic covered stent graft, followed by a non-covered stent graft for the arch, and a Dacron part for the ascending aorta” and that it has been designed to “reduce ischaemic times by more than 50%.”

The primary indications for the graft would be “sick octogenarians” or in situations where there is “dramatic malperfusion” (such as myocardial infarction, stroke, and prolonged visceral ischaemia). He reported that in a small pig study (of six pigs), there was a technical success rate of 100% and a visceral ischaemia time of 21 minutes.

Jakob concluded: “After passing all regulatory affairs with the hospital, four grafts are under construction for the first-in-man implantation.” He added at present, the graft was just designed to be implanted via conventional surgery (through median sternotomy), but said that “of course” they also planned to assess the transapical or transfemoral route as well.

Today, Martin Funovics (Vienna, Australia) presented data from the Restore (Relay endovascular registry of thoracic diseases) II registry, which he said confirmed the safety of the Relay and Relay NBS thoracic stent grafts (Bolton Medical) in thoracic endovascular aneurysm repair (TEVAR)

Funovics explained that Restore II was a prospective worldwide registry of 234 patients who have undergone TEVAR with a Relay device. He reported that the Relay device was available as a “clasped” version with conventional bare springs and as an unclasped version with covered springs (Relay NBS). Referring to the unclasped version, Funovics said: “This version for the first time has differential attachment modalities for the inner and outer curvature.” The inner two clasps, he commented, that are guided by long levers from behind rather than proximally. “During the opening process, these two levers can slowly and in a very controlled manner guide the inner curvature apeses to the aortic wall.” He added that the device has been specifically designed for the descending aorta.

The patients in the registry, Funovics reported, reflected the “typical TEVAR patient population”, but he added they did have a “substantial amount” of cardiovascular comorbidities compared with the typical TEVAR population.

Funovics commented that with the Relay and Relay NBS devices, the technical success rate was 95.3% and there was a very low rate of systemic complications. Additionally, the rate of mortality following the procedure was similar to other series.

He concluded: “The Restore II registry confirms the safety and efficacy of our differential detachment mode of the inner and outer curvature springs. The results were comparable, especially in terms of neurological complications, to other registries and a relative high rate of technical success was achieved.”