The CX Innovation Showcase is dedicated to highlighting what it takes for a physician-inventor to succeed and for innovative ideas in the vascular and endovascular arena to thrive. Yesterday’s session brought together leading industry experts, physician-inventors, engineers, medtech investors and start-up companies all focused on improving vascular disease management.
Chaired by Stephen Greenhalgh, the 2015 Innovation Showcase covered innovations across five areas: endovascular aortic, complex aortic endografting, peripheral, diagnostic and vascular access.
Andrew Holden (Auckland, New Zealand) presented for the first time at a scientific meeting, the first-in-man experience with the Advance 35 scoring balloon (Cook Medical) in haemodialysis fistula stenosis. He noted that it is well known that stenosis in the haemodialysis access circuit is a common complication for patients on haemodialysis, adding that regular surveillance is important, especially after intervention because restenosis is common. Holden said that the para-anastomotic and outflow stenoses are often resistant to angioplasty using conventional angioplasty balloons at nominal pressures, and frequently, ancillary measures are required, such as scoring or high pressure balloon angioplasty. These ancillary procedures, he said, come at a financial cost as well as a morbidity cost related to upsizing sheaths and guidewire exchanges.
In the early experience with a 0.035” guidewire compatible scoring balloon, specifically designed for the management of fistula stenosis, 39 stenotic lesions in 28 patients were treated. Acute procedural success, as defined by a residual stenosis of <30% was achieved in 38 of 39 patients (97%).
“This compares very favourably to an audit of consecutive patients at the same centre treated with standard angioplasty balloons where procedural success was only 48%. In the trial only one patient required an ancillary procedure to optimise the result where 11 patients required cutting balloon or high pressure balloon angioplasty in the audit group,” Holden reported.
Optical coherence tomography in a sub-group of patients confirmed the scoring effect in treated vessels. At one month, patency was 100%. Six-month patency will be evaluated soon.
“These promising results suggest this 0.035” guidewire compatible scoring technology could become a ‘first line’ tool for the treatment of dialysis fistula stenosis,” Holden concluded.
Bao Bui (Sherbrooke, Canada) made a case for in vivo antegrade fenestration of renal arteries in pararenal abdominal aortic aneurysms (AAA). He said that in vivo fenestration is associated with a low leak rate, it is easy to learn and to perform, there is no wait time using off-the-shelf devices, and the device is possible for emergency use.
He concluded stating that based on initial results (five patients, no leak and no migration 10 months follow-up, all AAAs and the TAAA have decreased in size), in vivo antegrade fenestration is a very promising, reliable technique that is easy to perform with existing devices.
Complex aortic endografting
Patrick Kelly (Sioux Falls, USA) looked at a paravisceral non-anatomical branch endograft system. Noting that repairing short neck, pararenal, paravisceral, and type IV thoracoabdominal aortic aneurysms is challenging because moving the seal zone more proximally increases the risk of paraplegia, he presented a novel approach for sealing just above the celiac.
“We envision the device to be completely off-the-shelf, to lessen or completely negate the need for rotational alignment, and deliver ordered, well-developed flow to the branch arteries. Until the devices are pre-manufactured, we are using physician-modified versions for patients with limited options. The device is made with a diaphragm, which allows for minimal aortic coverage,” Kelly said.
He explained that the paravisceral stent graft configuration is built from a 28–36mm Endurant stent graft (Medtronic) which is shortened to 30mm with the suprarenal fixation hooks left attached. The diaphragm is created from an ePTFE vascular patch. The lumens are made from Viabahn stent grafts (Gore). The paravisceral stent graft is introduced through the groin. The bridging stents for the renal arteries, SMA, and coeliac are introduced through the arm. Once the visceral segment is excluded, a standard EVAR is performed to exclude the remainder of the infrarenal aorta.
“Our experience to date has been one of excellent technical success and early branch vessel patency,” Kelly concluded.
Pierre Galvagni Silveira gave the early clinical results of the TAMBE (Gore) thoracoabdominal branch endoprosthesis. He reported that at 30-day follow-up there was no endoleak and treated branch patency was 100%.
Silveira concluded stating, “The TAMBE device is the only ‘all-in-one’ pre-cannulated off-the-shelf system, including aortic component and side branch stent graft. While the initial results are promising, longer term outcomes are needed to confirm this early experience.”
Shin Ishimaru (Saitama, Japan) presented the Najuta endograft for total branch repair. He said that the primary concept of Najuta was to design a tailor-made endograft suitable for the aorta of each individual patient. “The proximal end of the device is placed between zone 0 and 2, which constitutes the highly critical region involved with the aortic arch and branch arteries. Fixation of the endograft is successful if there is at least 20mm of healthy aorta from the left carotid or subclavian arteries to the margin of the aneurysm,” Ishimura said.
He concluded adding that with almost 200 cases now done in Japan, and five-year data on the horizon, the Najuta fenestrated endograft is a “promising device for aortic arch application”.
Jan Heyligers (Tilburg, Netherlands) discussed spiral vein reconstruction using the greater saphenous vein to reconstruct a neo-aorta in infected cases. Heyligers noted that research has shown spinal vein reconstruction to be technically feasible and a successful alternative for the Glagett-Nevelsteen procedure. He said that the advantages are that no training is necessary, there is no learning curve, diameter is not an issue and there is no morbidity when harvesting the deep vein.
Stephen Williams (Baltimore, USA) discussed helical 3D stenting with the BioMimics 3D stent (Veryan), maintaining that the Mimics data indicate in-stent swirling flow/endothelial wall shear stress could be beneficial to maintain long-term patency. “This is really the only stent in 12–24-month range study to date that seems to offer this improvement in avoidance of late restonotic events,” Williams noted.
He later announced that the US IDE trial for the BioMimics stent is upcoming, with the first enrolment expected by the end of this quarter.
Patrick Kelly presented the early results of paclitaxel after endorevascularisation, concluding that drug infusion balloons could have great potential.
“We believe it to be more favourable [than drug-coated balloons] in many regards, including: shorter regulatory path, lower device cost, and more flexibility in the therapeutic used,” Kelly maintained.
He explained that he has been working on this project with two parallel paths: clinical research using an already available infusion balloon, and bench top and animal research to evaluate various excipients. “In the clinic, we have seen an improvement in freedom from binary restenosis and freedom from target lesion revascularisation. On the benchtop and in animals we have evaluated cremaphor, urea, contrast, and Abraxane.”
He reported that notably, “Abraxane shows superior tissue penetration in our animal models when quantified with a validated high performance liquid chromatography method. The Abraxane is also superior in terms of biocompatibility without the need for any toxic solubility agents.”
The next step in the research will include a prospective randomised blinded clinical study of 150 limbs with de novo lesions.
David King (London, UK) returned to the CX Innovation Showcase this year after his winning pitch in the 2014 Dragons’ Den. Yesterday, he presented his Blue Dop technology (with which he won the 2014 £1000 Dragons’ Den prize), and made a case for the technology’s empowerment of nurses in vascular investigations.
King said that Blue Dop empowers tissue viability nurses working in the community to start patient treatment immediately, thus reducing costs for GP practices, reducing the number of hospital referrals, speeding up the patient treatment “journey” and reducing the load on vascular labs.
Dragons slayed by new dialysis graft technology
In the tradition of the CX Innovation Showcase, the highly-anticipated Dragons’ Den did not disappoint in 2015 with presentations of 15 new and innovative ideas from physician-inventors from all over the world.
With much to consider after two hours of impressive presentations, Jeffrey Lawson (Durham, USA) came out on top, winning over the Dragons and gaining the most votes in his favour for his dialysis graft technology.
Lawson spoke to CX Daily News about his technology stating, “It is a novel dialysis graft that is meant to protect patients when their dialysis graft needs to be cannulated by a sharp needle. You can only cannulate the graft or the blood-flowing portion safely and reliably—that is the nature of the innovation.”
In terms of progress, Lawson reported that animal testing with the device has been done and a very mature prototype design has been developed. Further, he said that his team has met with the US Food and Drug Administration (FDA) in light of plans for the first-in-man implant.
Commenting on the value of the Dragons’ Den, Lawson said, “It is a wonderful opportunity, and it is fun. It is also really good to see other people’s technology making progress.”
Speaking to CX Daily News, course director and chairman, Stephen Greenhalgh said, “The feedback I received from the Dragons was that this year saw the most wide-ranging, innovative group of presentations that we have ever had at Charing Cross, and based on voting results—where varying presentations received recognition from the individual Dragons—it shows how closely fought it was.”
Speaking of the future of the CX Dragons’ Den, Greenhalgh added, “I just want to ensure that Charing Cross always provides a platform for early stage innovation.”
Honourable mention was also given to Peter Philips (Didcot, UK) for his ideal compression stocking; Tim Chuter (San Francisco, USA) for his Inchworm balloon; and Lindsay Machan (Vancouver, Canada) for his uniform pressure non-straightening angioplasty balloon.