For the very first time, three full-scale sterile hybrid operating suites from GE Healthcare, Philips and Siemens were on display at CX. The importance of quality imaging as a prerequisite for improved clinical outcomes was emphasised in every section of the main programme. This went hand in hand with calls from physicians for high-quality image availability in the intraoperative setting.

Imaging is certainly at the heart of endovascular intervention, and it is now widely accepted that using the best available imaging can have a direct impact on achieving the best clinical results. With the blurring of boundaries between specialties in the endovascular arena, there was a clear need expressed by clinicians at CX for improved imaging at the intraoperative stage. Delegates at CX35 are split in nearly equal proportions along the disciplines of vascular surgery, interventional radiology and interventional cardiology.

Georg Nollert, director, Global Marketing, Siemens, told CX Daily News: “I am very happy that the focus on imaging is increasing. In the past, vascular surgeons were satisfied with inferior image quality and other interventionalists such as radiologists and cardiologists benefited from using the best available imaging. I believe that surgeons ought to have the same image quality in order to get the best results.”

In the preoperative and postoperative setting, ultrasound and other sophisticated imaging modalities such as CT or MRI are widely available. Nollert said: “Intraoperatively, however, imaging was limited to the use of C-arms (2D fluoroscopy) in the past. Therefore,  one available solution was to enable the superimposition of the preoperative images with the intraoperative images. Using preoperative CT or MRI, this then creates the 3D road map that interventionalists could use for very sophisticated interventions.

“Another possibility was just to use intraoperative cone beam CT, and we are getting close to conventional CT quality with this. The elegance of this solution is that the images are automatically registered to the patient and there is, on the other hand, the actual anatomy of the patient on the table that is probably not the anatomy that you have on the [preoperative] CT (because he is in a different position and may also be in a different state of hydration). We therefore believe that the most precise imaging is done intraoperatively, particularly when you have inserted wires or other devices that have changed the anatomy. This might bring up the issue of distortion/deformation of the vessels which can be quite substantial and the overlay could somehow suggest that the operator is in the right lumen, even if they are not.”

Nollert told CX Daily News that in the past, the issue with cone beam CT was one of image quality, particularly with reference to contrast resolution and that Siemens has been working on improving this aspect. “We now have new algorithms to reduce metal artifacts and also better detectors in the latest family of systems, the Artis Q. Artis Zeego also has the latest technology and the latest detectors and we have increased the contrast resolution for cone beam CT substantially. It is important to bear in mind that all cone beam CT is not equal. We have new protocols that result in the quality being much superior to regular/conventional CT. However, image quality for cone beam CT depends on reconstruction algorithms, and how you deal with artifacts and distortion, and those algorithms are widely different in the market.”

He highlighted that the Artis Zeego was a flexible, robotic system that can adjust to the table and to being used by the whole team in the operating room. The system also allows for maintenance of the sterility and environment of the operating room as it keeps the ceiling free for uninterrupted laminar flow, or use of operating room lamps, for example. “With regard to 3D capability, the Artis Zeego has some absolutely unique features and can image large volumes, fast and achieve a superior image quality,” he said.

Clinicians in the session made the point that the robotic arm with the automated motion had the drawback that the user could not always predict how the system was going to move and often found that it was quite hard to anticipate the movement.

Kirsten Zuurmond, clinical scientist, Philips Healthcare and Koen Noordermeer, Business Development Manager, Philips Healthcare, told CX Daily News: “Philips is very concerned about the quality of intraoperative imaging. In order to reduce radiation dose and contrast values, Philips offers the possibility of fusion imaging where clinicians use the preoperative CT as a navigational map during the procedure. We also offer the flexibility of working with cone beam CT, such as in emergency situations, so that it is possible to make an accurate 3D image at the intraoperative stage.

They highlighted the flexibility of positioning the c-arm Philips system within the hybrid operating room, the advantages offered by the new system Alluraclarity, in achieving significant dose reduction, without compromising on the image quality available to physicians.

3D superimposition on fluoroscopy is not yet ideal

During the Monday morning session the issue of distortion resulting from overlaying preoperative 3D images intraoperatively was discussed. A panel comprising of chairman Peter Taylor Tara Mastracci, Cleveland, USA, Krassi Ivancev and Ian Loftus, both London, UK, noted that with fusion imaging, there was no compensation for vascular distortion and that there was imprecise fusion usage for endograft positioning and cannulation of target arteries.

“One of the issues that many clinicians have with fusion imaging is its lack of responsiveness to deformation, but most believe that a fix is on the horizon,” Mastracci said. Sixty two per cent of the audience in the session also voted against the motion that fusion of preoperative datasets is ideal.

Zuurmond highlighted that clinical opinion was clearly divided on the topic with some clinicians experiencing a high degree of accuracy. She then also explained that the company was focusing on the ostia as a target in fenestrated EVAR procedures and noted that they hoped to provide the extra help that could be useful in the area.

Noordermeer then added: “We see the benefit of the current technology but are of course working on improvements for the future to make it even more accurate and applicable. We are interested in is bringing solutions that are easier to use in the hybrid operating room and are working on automating workflow steps, making access easier and providing stepwise guidance for physicians.”

Ease of use

Gregory McIff, global director, Cardiovascular Strategic Marketing and Delphine Germain, global product manager for Hybrid OR, GE Healthcare, told CX Daily News that flexibility in the operating room, ease of use for physicians and advanced image quality were optimised to the best degree that technology allowed today in the GE systems.

In response a questions about image quality not being as good as it could be at the time of intervention, McIff noted that image quality was subjective to the user. “We know from technology that a flat panel detector gives a clearer image than an image intensifier system, so you are going to see some changes in that. But when you are dealing with aortic interventions the ability of a system to provide good imaging is perhaps, adequate. You can always have better imaging—I would love to drive a Rolls Royce, but I have to make do with my Chevrolet!”

Germain said, “We definitely emphasise that the system is easy to use. You can have the best thing in life, but it has got to be accessible, not complicated to use, too. This is an area we will keep investing in: improving the ease of use. We already have systems that allow surgeons to learn fusion imaging from tableside. With regard to superimposing preoperative imaging data within the Hybrid OR, the technique is getting complicated and it is important for us to make sure that people can use it on a routine basis.”

Both highlighted that GE focused on combining the best of the hybrid operating room with the best of the advanced imaging techniques. They drew attention to the fact that the Discovery IGS 730 was not mounted either on the wall or on the ceiling but that it could move freely in the room.

 
“The system confers the benefit of mobile systems that can move in the room freely so that clinicians can have access to patients, and at the same time have the ability to be brought back into imaging position and have all the advantages of a fixed system in terms of imaging such as 3D imaging and 3D fusion,” they said.

This year, the ilegx multidisciplinary team, continuing in its aim to reduce the number of leg amputations, broadcast—for the first time—edited live below-the-knee endovascular procedures to the Far East, in association with Abbott Vascular. Also, as part of the ilegx programme, the King’s College Hospital Open Access System showed the latest treatment options for diabetic foot. Innovative methods of foot revascularisation were also discussed and a guidewire tutorial was taught.

The morning session titled “Electronic Endovascular Education—Edited live cases broadcast online to the Far East”, chaired by Max Amor (Essey-les-Nancy, France) and Roger Greenhalgh (London, UK) showed delegates three complex below-the-knee procedures from Germany, Italy and France.

The first case was performed by Andrej Schmidt in December 2012 in Leipzig, Germany. The second procedure was carried out by Roberto Ferraresi in March 2013 in Milan, Italy, and Eric Ducasse undertook the third case in Bordeaux, France, in March 2013. Ducasse said: “In the past decades we have seen major advances in the treatment of below-the-knee lesions with dedicated materials and retrograde approaches to peripheral arterial disease.” For this case, Ducasse showed below-the-knee techniques using Abbott Vascular materials. He showed a retrograde approach through the peroneal artery followed by guide wire proximal recapture and successful balloon angioplasty.

After each case, Dierk Scheinert, Leipzig, Germany; Flavio Airoldi, Sesto San Giovanni, Italy; Ferraresi, and Ducasse, answered questions, via video link, from delegates watching in the Far East. Questions came from Japan and India, and also from Tunisia.

At the end of the session, Greenhalgh told delegates: “This Electronic Endovascular Education session has been a wonderful experience with great educational value. I have to thank these physicians from Germany, France and Italy for those fantastic results and for sharing with us all that can be done to save legs.” 

He added: “This experience forms part of the CX ilegx Collaboration Day and ilegx stands for interdisciplinary management of legs because we are concerned that too many legs are being amputated,”

Greenhalgh told CX Daily News: “In these times of economic difficulties—when flight costs are on the rise—this online educational experience could be a cost-effective way of sharing education. We would like to invite the participants of this experience to share their opinion via twitter or facebook on whether this should be a pattern to be followed in future CX meetings” 

King’s College Hospital Open Access System aims to save diabetic foot

The King’s College Hospital Open Access System, London, UK, “includes a multidisciplinary team of podiatrists, nurses, microbiologists, vascular surgeons, orthopaedic surgeons, diabetologists and interventionalists dedicated to providing an urgent, immediate treatment to patients who are at risk of developing necrosis, gangrene and losing their legs,” Michael Edmonds, King’s College Hospital, told CX Daily News. “The two drivers for this—in diabetic patients—are infection and ischaemia. Rapid diagnosis of infection and rapid treatment will prevent the progression of the necrosis. At the same time, the vascular system should be addressed and we should go forward with revascularisation, either with angioplasty or bypass, depending on the degree of the circulation problem as soon as possible,” he added. Edmonds presented an update entitled “Rapid referral and treatment within the concept of the diabetic foot attack” at the CX ilegx session.

Physicians with different specialties from the King’s College Hospital Open Access System also gave presentations at the ilegx Collaboration Day on their experience treating diabetic foot as a multidisciplinary team.

Jason Wilkins, London, UK, presented a modern interventional approach to the diabetic foot. He told delegates, “The modern interventional approach to the diabetic foot begins with teamwork and recognition of patient-centred care being at the forefront of the team approach. Ischaemia with neuropathy or infection is considered an emergency and robust patient pathways are mandatory in providing timely intervention.”

Wilkins highlighted that revascularisation was a basic requirement for successful treatment and amputation prevention. “Revascularisation may be surgical, radiological or a combined approach according to the presentation and nature of disease and distribution,” he commented.

According to Wilkins, modern techniques and equipment provide the interventionalist with excellent tools for revascularisation with angioplasty, stenting and recanalisation of multiple long occlusions. He said: “The understanding and availability of modern equipment and techniques along with an effective multidisciplinary and timely approach to urgent revascularisation result in improved outcomes for our patients.”

Hisham Rashid, vascular surgeon, London, UK, presented “Distal and ultra-distal bypass: a discussion on the foot angiosomes—fact or fiction?”

Rashid told delegates that the angiosome concept was developed in 2006 by Attinger. He commented on a study—in press—that he undertook to evaluate the impact of the angiosome concept in a group of 142 diabetic and non-diabetic patients who underwent distal and ultra-distal bypass surgery for critical limb ischaemia with significant foot tissue loss. Rashid reported: “In this cohort of patients the healing and time to healing was not affected by the angiosome revascularised, but was significantly affected by the quality of the arterial pedal arch. In patients with no pedal arch, the healing was significantly slower and inadequate compared to the complete and incomplete pedal arch subgroups. However the amputation-free survival rates were similar in all groups.”

International input to limb salvage

Also, as part of the Kings College Hospital Access System programme, speakers from Europe and USA gave their views and experiences on limb salvage.

Carlo Setacci, Siena, Italy, talked on the latest guidelines on diabetic foot treatment: The Italian consensus document. Carlo Caravaggi, Milan, Italy, presented a new integrated surgical approach—based on timing—to reconstruct the diabetic foot.   Christopher Attinger, Washington, USA, told delegates about surgical care of the wound with debridement and planning of amputations and reconstruction. An interventional approach to the diabetic critical limb ischaemia patients vs. non-diabetics was presented by Roberto Ferraresi, Milan, Italy. David Armstrong, Tuscan, USA, spoke on techniques to correct foot deformity by surgical means.

Revascularisation challenges

In the afternoon, Roger Greenhalgh, London, UK, chaired the session on revascularisation challenges on the treatment of critical limb ischaemia.

Frank Vermassen, Ghent, Belgium, highlighted the importance of keeping vessel patency in the long run. He said: “Sustained patency of the wound-related artery is mandatory to optimise the chance for wound healing, to avoid repeat intervention and to preserve the limb.” Thomas Zeller, Bad Krozingen, Germany, said: “Patency is necessary but not sufficient for wound healing and ultimate limb salvage.” He added, “Drug-eluting balloons may be the solution to achieve the necessary patency levels within the extensive multivessel arterial disease typical of critical limb ischaemia.”

In the discussion, the question of using more than one balloon to achieve the necessary patency in critical limb ischaemia patients was raised. However, this approach would increase costs. Greenhalgh made the point that only patients with insurance companies willing to pay for this and patients who can afford it would receive the treatment.

At the Abbott Satellite Symposium, yesterday, Ian Loftus (London, UK) reviewed the data for percutaneous closure in endovascular aortic procedures, stating that the percutaneous closure approach was “technically feasible in most cases, is safe, and leads to early mobilisation and reduced length of stay”

Loftus explained that with endovascular aortic aneurysm repair (EVAR), the traditional femoral cutdown for vessel access was still used in many cases. He commented: “Studies have demonstrated groin complication rates ranging from 5% to 15% associated with femoral cutdowns, including wound infections and lymphatic leaks. This can hinder recovery and lead to prolonged length of stay.”

He added that a percutaneous approach using arterial closure devices could potentially avoid many of these complications. Loftus reported: “Previous series and a single small randomised trial have demonstrated high technical success rates and significantly shorter operation times, quicker time to ambulation, reduced length of stay and reduced overall procedural costs associated with using the Abbott Prostar XL device [for percutaneous closure].”

According to Loftus, data from a US multicentre randomised clinical trial comparing percutaneous closure using the Proglide closure device (Abbott Vascular) with standard surgical cutdown found that major access site complications were significantly lower in the percutaneous group (6% vs. 10% for surgical cutdown) and that minor complications were halved (4% vs. 8%). He added: “There was also a significantly shorter procedural time (106 vs. 141 minutes) and time to haemostasis (10 vs. 23 minutes).”

Concluding, Loftus stated: “Complete percutaneous treatment is technically feasible in most cases, is safe and leads to early mobilisation and reduced length of stay”. He commented that the complication profile of this approach was different form the open approach, but said complications could be minimised with “prudent case selection, training and careful device deployment.”

Also at the “Close with confidence” symposium, Matt Thompson (London, UK) spoke about “tips and tricks” for percutaneous closure. These tips included being aware of blood clots, the importance of being patient, and advice on accessing the common femoral artery. He said: “Getting the correct puncture site is absolutely key to a successful procedure. Ultrasound is the best way of ensuring accuracy of puncture.” He concluded that the percutaneous approach was now the default approach for all endovascular procedures at his centre (St George’s Vascular Institute, London) and they had seen an improvement in patient outcomes after adopting the approach. Thompson added there was “definitely a learning curve” with the percutaneous closure approach.