Noticias

Noticias

  • Título: Seen and heard at Charing Cross 2016 in London – April 26-29: by Dr. Frank Criado
  • Fecha: 31-05-2016

  • Seen and heard at Charing Cross 2016 in London – April 26-29

    Frank J Criado, MD, FACS, FSVM


    The headline on the front page of the CX Daily News of Wednesday April 27 summed up nicely what we saw and heard in the Upper (main) Auditorium the first day (April 26): “Good day for drug-coated balloons, swirling flow stents and drug-eluting stents”.

    Clearly DCB angioplasty keeps rising, especially for moderate length non-complex SFA lesions. Support for the use of pre-treatment in calcified and severe disease is on the ascendancy as well, either in the form of balloon pre-dilatation or atherectomy/debulking followed by DCB angioplasty to diminish the risk of restenosis or re-occlusion.

    The use of pre-dilatation before DCB was discussed at length, Overall, there was ample support (87% of the audience polled at the time) for its use, especially for complex, calcified and severe disease

    Various approaches were discussed positively for treatment of long and very long lesions, including the use of a single long stent, and various combinations of therapies as discussed. And there was support also for a continuing role of surgical bypass.

    Together with optimal medical therapy and smoking cessation, supervised exercise was shown (again) as an excellent tool for management of claudicators – without intervention. But on the downside, it has emerged that it is costly and patients’ non-compliance is quite high.


    New data were presented on a a few important areas of the PAD landscape:

    * Presentation of the CTO imaging cohort from the Medtronic IN.PACT Global Study revealed excellent outcomes after use of the Admiral DCB angioplasty catheter for such extensive disease: primary patency of 84.4% and clinically-driven TLR of 12.2% at 1 year;

    * There was also re-affirmation of the excellent results IN.PACT Admiral DCB achieves in diabetics and in women;

    * Additionally, Dr. Virmani delivered an impressive talk on the differences between Admiral and Lutonix DCB devices, and why the results seem significantly better with the former. She showed studies and histology images that clearly demonstrate the ability of the IN.PACT Admiral formulation and design to deliver the Paclitaxel drug in a more efficient way and, most significantly, with more sustained action within the vessel wall where it remains for a much longer period of time (3-6 months) when compared with Lutonix;

    * The 12-month interim data for Spectranetics ILLUMENATE Global Study showed a primary patency rate of 84.7% at 1 year. This is another piece of information that re-affirms the excellent results achieved when using the Stellarex DCB balloon – still awaiting FDA approval. The observation was again made that Stellarex matches the best results achievable with DCB angioplasty (with any device) and doing so with a lower level of drug concentration (as stated by Prof. Zeller);

    * Prof. Gaines made an impactful presentation on “swirling flow”, bringing to our attention that blood flow is not naturally laminar but helical or swirling. And that stents inducing such flow pattern improve outcomes. He then focused on the design and early results with use of Veryan’s Biomimetic stent (not available in the USA) that promises to deliver DES-like results. The Supera stent shares some of the same characteristics and is rapidly emerging as a superior tool for complex disease and anatomically challenging segments (ie. the popliteal artery). There was a consensus of sorts that helical stents and biomimetics will be the design of choice moving forward;

    * An update on the 5-year results of Zilver PTX DES stent results was presented. And the study continues to impress.


    I was a bit surprised that, as a technology class, atherectomy received relatively little attention. One significant talk on the use of combined directional atherectomy/DCB angioplasty suggested (again) that it may well prove to become a winning strategy for complex lesions – in-stent restenosis included.


    The second and third days were all about the aorta and endograft technologies. Most impactful was the session on Meta-analysis of Individual Patient Data from the combined EVAR1, DREAM, OVER and ACE randomized clinical trials that compared elective endovascular repair (EVAR) and open surgical repair (OR) of AAA. The meta-analysis revealed that, overall, there was no difference with regard to survival benefit (either total or aneurysm-related) between EVAR and OR over the first 5 years of follow-up. The investigators noted that in the first 6 months after randomization, total and aneurysm-related mortality was lower in the EVAR group. But at 12 months, there was no difference between groups for health-related quality of life. There was discussion and speculation on the reasons why the initial benefit of EVAR had disappeared.

    And for the first time, the 15-year results of the EVAR 1 trial were presented. Important to keep in mind, these data are based on devices implanted between 1999 and 2005 – the first generation of commercial stent-grafts. The re-intervention rate was high for EVAR, and they occurred throughout the follow-up period. Aneurysm-related mortality also occurred throughout the follow-up period.

    As previously noted in the 2010 Annals of Surgery article by Wyss et al., EVAR was associated with a rupture rate of 0.7 ruptures per 100 person-years. The death rate associated with secondary sac rupture was 67%. The “cluster of concerns” described in the 2010 article was again emphasized: endoleaks types I and III, endoleak II with sac expansion, device migration and kinking. Panelists and audience discussed the never-ending requirement for surveillance and follow-up, and the absolute need to detect

    sac expansion before rupture. “A perfectly good and well placed endograft can leak later due to continued aortic dilatation and expansion.”

    Most intriguing was also the apparent higher occurrence of cancer in the long haul on EVAR patient – not after OR. Several remarked that radiation exposure is likely the culprit, and that present-day CT scan studies deliver 20 times less radiation than those used in the year 2000.


    The EVAS technique and use of Endologix Nellix device received a great deal of attention as the results of the Global Registry were presented. Nellix performance continues to impress as it seems capable of producing excellent outcomes on good and bad AAA anatomies alike, and virtually eliminating type II endoleaks. A number of type I endoleaks have been reported, especially early-on in the investigators’ experience, and largely related to technique shortcomings that are being addressed and overcome. FDA approval of the Nellix device is eagerly awaited, and expected later in 2016.

    On a related topic, the Arsenal Medical/Medtronic project was presented (by Andrew Holden) for the first time in a public forum: this sac-filling and sac-sealing technology is based on the use of a polymer that is delivered to the aneurysm sac after implantation of a conventional stent-graft. Holden specified that “key product design features include a polymer that is specifically engineered for sac sealing with room temperature storage and limited on-site prep with an automated polymer dispensing and monitoring system that stops dispensing when the sac is sealed. This polymer is a thick flowing material when dispensed that preferentially fills open spaces around the graft before filling narrower spaces, and then becomes an

    elastic solid. The material properties allow the polymer to minimally penetrate into branch ostia in a predictable way. It is radiopaque to allow monitoring while dispensing but not to obscure graft visibility”. Biocompatibility studies are currently being performed and first-in-human clinical studies are planned for 2017.



  • Fuente: endovascular.es