Vascular News Philips supplement – January 2020

January 2020 | Educational Supplement

The next generation hybrid OR Advanced endovascular treatment in a versatile operating room

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This educational supplement has been sponsored by Philips

Interview

Philips Vascular Suite: Excellent vascular care with Azurion FlexArm The new Philips Vascular Suite with FlexArm offers imaging flexibility for diverse procedures and positioning freedom for medical teams, limiting time in the operating room (OR), reducing costs, and helping clinicians to improve patient care. Here, Hans-Henning Eckstein and Heiko Wendorff (Klinikum rechts der Isar, Munich, Germany) discuss their experience with various elements of the new hybrid OR system.

“A major advancement”

We decided to set up a hybrid OR at our hospital because, in general, bringing together diagnostics and therapy in one room is a major advancement, a revolution, and image guided therapy is very useful in vascular surgery in particular. It should be considered standard equipment in any good vascular clinic.

In comparison to the situation we had previously, we have far better imaging than we used to have in that it is more precise with low radiation, which is good for the patient but even more so for the physicians and the nurses in the OR. The benefit goes beyond the hospital too.

Our referring clinicians, for example, can rely on a modern vascular surgical clinic where they can be sure that we are able to make procedures as safe, quick, and efficient as possible. The main benefit for the patient, and also for the referring clinician, is that we are no longer biased to one or the other mode of therapy.

We can now clearly advise the patient.

For example, if a patient had a long occlusion of the femoral artery, we could offer bypass surgery, but could also offer endovascular treatment. We can openly discuss the benefits and drawbacks of both procedures and I think this unbiased advice is very important.

The FlexArm is the most important machine in our OR. In the OR we have to be able to access the patient from both sides, the anaesthetist has to be at the head end of the patient, and then new machinery comes in which also has to fit, and so space is at a premium.

It is very beneficial for the clinical team that the FlexArm system is something that can be brought in from either side of the patient or from above, and can also be moved away once you do not need it any longer.

Better imaging with low radiation The advanced imaging is very important for us in that we are able to get better images

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easier because the angulation is very easy. In addition, peripheral interventions are easier with the FlexArm because you are able to use the angiograph for all parts of the leg, including the toes, so you can treat wherever you need to.

The volume of endovascular aortic arch procedures will increase in the near future.

These are very challenging due to the stroke risk, among other factors, but I think that endografts will be better suited to these kinds of procedures in the future and so we will be able to treat more patients.

Another example would be deep venous interventions. These need very good imaging to be able to treat. The caval vein, for example, has a large diameter of 2–3cm, which a standard C-arm would not pick up.

Flexibility and sterility

Hans-Henning Eckstein

Heiko Wendorff

with low radiation. We are able to take on complicated cases and so in many ways are the last stop for the patient before having to undergo open surgery. It is possible for us to do many intricate procedures in the lower leg, for example, or complicated ones in the renal or mesenteric arteries.

Beneficial in complex interventions

The procedures which benefit the most from the FlexArm system would be complex endovascular aortic interventions like fenestrated endovascular aneurysm repairs (FEVAR), standard EVARs, thoracic EVARs, and branched thoracoabdominal interventions, when you need to come close to the renal and mesenteric arteries, and with the FlexArm machine this is a lot

We decided to set up a hybrid OR because, in general, bringing together diagnostics and therapy in one room is a major advancement.”

The system is very flexible and it is now possible to move the C-arm around the surgeon. You can also store the positions of the C-arm so that even when you move it away, with one button you can use the exact same position and the same angiograph that you had before. This is very important for us because it means less radiation.

The ceiling-mounted element makes it easier to clean the whole OR. For example, it is possible to clean the floor without having to move machines or cables. In terms of sterility, all the requirements of the law and those of our hospital are fullfilled. We are considering taking part in a sterility study with Philips.

Planning and accuracy

Philips VesselNavigator is very important for complex aortic intervention because you can produce a 3D model preoperatively and then add this to the C-arm. You can then see what position the C-arm needs to be in during the procedure and with the press of a button the C-arm will move into this required position.

It is very important to understand better the anatomy of complex aortic cases before the operation and so VesselNavigator really helps in this regard.

Again, there is low radiation with VesselNavigator and, finally, it reduces surgery time because you can preoperatively test a lot of angulation using the 3D model, without having to do this on the patient.

Prof. Hans-Henning Eckstein is Director of the Clinic for Vascular and Endovascular Surgery at Klinikum rechts der Isar in Munich, Germany.

Dr. Heiko Wendorff is Senior Physician of the Clinic for Vascular and Endovascular Surgery at Klinikum rechts der Isar.

January 2020

Technology

Philips Azurion Hybrid OR

“Integral in building my practice”: VesselNavigator in complex vasculature While VesselNavigator can be used for any type of endovascular procedure, it is especially beneficial for complex and tortuous vasculature where it is challenging to accurately navigate and place stents, or for procedures where contrast use should be minimised. Philips VesselNavigator provides an intuitive and continuous 3D roadmap to guide you through vasculature during the entire procedure, which reduces the need for a contrast enhanced run to create a conventional roadmap. Prof. Adam Beck (Division Director of Vascular Surgery and Endovascular Therapy, University of Alabama at Birmingham [UAB], USA) details his clinical experience using the Philips hybrid OR, focusing in particular on the benefits of VesselNavigator in complex interventions.

You are quite unique in performing FEVAR procedures.

Can you tell us more about these?

Fenestrated EVAR procedures are a big Adam Beck part of my practice.

In fact, it is probably the procedure I am most passionate about and is really what I have built my whole practice on. I think that without a hybrid operating room we would not be able to perform those procedures for the most part, and so the Philips system has certainly been integral in building my practice.

What are the biggest challenges of these procedures?

New ultrasound solution: Photorealistic 3D rendering

To meet the needs of complex surgery, high-quality imaging is becoming increasingly important. One of the key features of the Philips hybrid OR is the ability to obtain high-quality, 3D images.

TrueVue, with its virtual light source, is a proprietary advanced 3D ultrasound display method that delivers lifelike 3D ultrasound images.

Probably the biggest challenge is revascularising the patient’s branched vessels or catheterising and then revascularising them. If you use 3D imaging appropriately, it makes that process considerably easier and less stressful. Deploying the endograft becomes easier, and revascularising the branched vessels becomes a lot less of a technical exercise because the deployment is so accurate.

What is the role of advanced imaging like VesselNavigator in FEVAR procedures?

VesselNavigator allows accurate deployment of devices and also has the ability to manage radiation exposure. The C-arm can be positioned perfectly at the start of a case and therefore when I introduce fluoroscopy, there will be an exact perpendicular shot across the origin of the vessel. It takes just a few moments to get out of the endograft and into

the vessel when we use VesselNavigator.

the location of catheters and devices relative to anatomy during interventional procedures.

It can help with the communication of complicated echo images among caregivers in the interventional suite, providing viewing context for the echo image to enhance procedural confidence.

diagnostic or interventional. It can help with the communication of complicated echo images among caregivers in the interventional suite, providing viewing context for the echo image to enhance procedural confidence.

For all 3D volumes

The touchscreen user interface has been designed to improve 3D workflow, and allows users to pinch, zoom and rotate the 3D data set via fingertip control.

TrueVue illuminates tissue detail and creates depth perception with all 3D volumes,

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How has VesselNavigator affected patient outcomes?

Although it is difficult to demonstrate actual patient benefit without a large number of patients, VesselNavigator has allowed us to spend less time in the operating room.

Fingertip control

Clinical perspective

A recent survey found that 90% of 42 clinicians felt that the TrueVue improved viewing of anatomical structures.1

Better visualisation

TrueVue photorealistic 3D rendering is designed for better visualisation of interventional devices. TrueVue’s virtual light source and the simulation of light interacting with tissue can make it simpler to visualise

Images of an endovascular aortic aneurysm repair in two different patients using VesselNavigator. Ring markers indicate the ostia and landing zones.

References

TrueVue

1. Results obtained during user demonstrations performed in December 2017 with the EPIQ CVx and the iE33 systems.

The research was designed and supervised by UseLab GmbH, an independent and objective engineering consultancy and user interface design company. The tests involved 42 clinicians from 17 countries.

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Comment & Analysis

“The best of both worlds”: Renowned limb salvage centre embraces the hybrid OR The Prince of Wales Hospital in Sydney, Australia, is a leading limb salvage centre.

Ramon Varcoe talks though the hospital’s experience with the Philips hybrid OR, highlighting benefits for all involved and concluding that “this is the most user friendly system that we have ever encountered”.

SETTING UP A HYBRID THEATRE AT Prince of Wales was always a priority because it brought the highest quality of patient care to this institution. Our new hybrid is the highest quality hybrid OR in the Southern hemisphere and our patients at Prince of Wales Private Hospital will receive the full benefits of that.

By the very nature of the way we deal with patients with vascular disease in this country, we are often operating on all different parts of the body, from neck to feet, and an operating list will frequently traverse that entirety. At Prince of Wales Private, we are renowned as a limb salvage centre, so patients come to this hospital because they are facing the prospect of limb amputation. As a result, we do a lot of work on lower extremity revascularisation.

I would expect to be really focused on the legs in the new hybrid OR. But equally, we may be doing a carotid procedure or we may be operating on someone’s aorta to prevent them having ruptured aortic aneurysm.

This operating room is a really interesting one, partly related to the table, which is a fully breakable surgical table and differs considerably from the floating tables that

Ramon Varcoe

Referrers and patients can have a great deal of faith that we are providing the highest quality imaging in the most sterile surgical environment.” are in most angiography equipped operating rooms. This enables us to do a full range of open surgical procedures in all sorts of positions with much more versatility and flexibility than what we have had in the past.

The Philips FlexArm system gives us the ability to treat all sorts of patients in a myriad of different ways. We can treat patients with both open surgery and endovascular procedures all at once, which really provides a great deal of benefit to our patients. They can stay in the one stable environment and have all their procedures performed in that

one setting.

That is truly unique and we think we have achieved the best of both worlds. Philips and Getinge working together to install the new hybrid room was a seamless process, and I was really pleased by the way that all played out.

The usability of the Philips FlexArm system is incredible. We have a lot of feedback from our nurses, our radiographers, and of course from the clinician users at the front line to say this is the most user friendly system that they have ever encountered. Part of that comes back to the versatility of the C-arm and the way it moves around the table, and part of it comes back to the Azurion operating system, which is incredibly user friendly. Referrers and patients can have a great deal of faith that we are providing the highest quality imaging in the most sterile surgical environment.

It is likely that this will translate to the best care for patients and that is what we are all here for. Prince of Wales Hospital has been a leader at the forefront of installing hybrid theatres within their hospitals. The new Philips FlexArm system combined with an integrated surgical table provides a completely versatile and state-of-the-art facility for our patients. What that means is that we can go about the business of saving legs in patients who would otherwise have had amputations. The loss of a limb is a devastating experience for patients, their families, and frequently leads to early loss of life.

The most amazing part about the FlexArm is the manoeuvrability of the C-arm around the patient, and that might not sound like much, but these rooms can get very crowded at times and the ability of the C-arm to come in from any direction gives us a huge number of options. It enables us to treat parts of the patient’s body that we would not otherwise have been able to get to easily and therefore derives better care for those patients.

This new FlexArm has great technology to manage the radiation exposure to patients and to the physicians like myself who spend their lives working right next to the machine. That is incredibly important. I anticipate having a 30-year career performing these angiographic procedures so to use low radiation doses is a massive advantage and it is one of the things I love most about this machine.

Prof. Dr. Ramon Varcoe is the Director of Operating Theatres and Director of Vascular Institute at the Prince of Wales Hospital in Sydney, Australia.

All rights reserved. Published by BIBA Publishing, London T:+44 (0)20 7736 8788, publishing@bibamedical.com.

The opinions expressed in this supplement are solely those of Philips and the featured physicians and may not reflect the views of Vascular News.

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January 2020

Multipurpose

Philips Azurion Hybrid OR

Optimise lab performance in a multipurpose hybrid OR OR Manager Joss Giese (University Medical Centre Schleswig Holstein, Kiel, Germany) talks through the multipurpose nature of the Philips hybrid OR, highlighting both clinical and economic benefits. He concludes that the system supports a wide range of clinical procedures in one room with very positive economic benefits.

THE FIRST HYBRID OR AT UKSH Hospital in Kiel, Germany, was opened back in 2013, and it is interesting to note that this first hybrid OR was promoted by the cardiac surgeons and the cardiologists. Our second hybrid OR was built in 2017 and opened in 2018. As well as cardiac surgeons and cardiologists, we also had spine and vascular surgeons involved in the opening of this second hybrid OR.

Kiel operating room

Into the future: The hybrid OR programme at WVU Heart and Vascular Institute

The main reason for us to install this second hybrid OR was that the capacity of one hybrid OR was simply not sufficient, especially when we focus on its multipurpose use. There are an increasing number of disciplines using the vicinity and that is why we decided to open a second room. There are now a number of Joss Giese specialities which use the hybrid ORs in our hospital, including the cardiac surgeons and cardiologists, spine surgeons, vascular surgeons, and interventional radiologists. Of course, many of these specialities will work together in the room, so vascular surgeons with the radiologists, trauma surgeons with the spine surgeons, and cardiac surgeons with the cardiologists.

The addition of hybrid rooms at UKSH and their multipurpose nature have allowed us to perform new procedures in a perfect environment, such as minimally invasive spine surgery, the treatment of structural heart diseases, and complex vascular procedures, which all require the involvement of multiple specialities in one room.

The Azurion system has a number of elements which are specifically helpful in the multipurpose setting. For example, Philips has adopted procedure cards which means you can standardise the setup for any LUKE MARONE

“ Having a vast array of products across the entire spectrum when it comes to vascular care allows Philips to think bigger, to think, ‘Where do we need to go next?’. That is how we wanted to think in Luke Marone (Co-director WVU Heart West Virginia. We wanted and Vascular Insitute, WVU Medicine, a system that could grow Morgantown, USA) and Amy Bush (Vice President, Clinicial Operations, WVU with us, move forward with Medicine) consider the future-readiness us, whatever technology of the multipurpose hybrid OR. may bring.”

January 2020

procedure. The user interaction is very intuitive and the image fusion tools, like VesselNavigator and HeartNavigator, are great support.

Thinking about the benefits of having a multipurpose room for UKSH in particular, we have increased the number of procedures that we have done, reduced room preparation time, and therefore optimised procedure efficiency.

The economic benefits have been very positive. Of course, there is a financial benefit in so many specialities being able to share the expense of the hybrid OR and of being able to conduct so many complex procedures in one location. For the patient, there is a significant clinical benefit in that they are able to undergo complex combined procedures in one room which, before the adoption of the hybrid OR, would not have been possible.

The user interaction is very intuitive and the image fusion tools are great support.”

AMY BUSH

“ From an economic perspective, the future of healthcare is more and more based on what we call value-based healthcare, and as we drive quality we must stay at the top of our game from doing the most advanced procedures in the most efficient manner in the most cost-effective manner.

The Azurion unit is positioning us well and will serve us for years to come.”

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Setup process

Building the hybrid OR: A customer’s view Philips advises hospitals to adopt a five-step approach to building a new hybrid OR: discover the concept, define the procedure mix, outline requirements, design the room, and optimise for use. Eric Beekmans (OR Manager, Maasstad Ziekenhuis, Rotterdam, The Netherlands), shares his experience building a hybrid OR.

Investment

We decided to invest in the Azurion Hybrid OR to replace the first hybrid room that we had installed in 2011. The old one is too small and the air flow system needed to be improved. Furthermore, the Azurion FlexArm was exactly the system we desired because of the compact mobility around the operating area and the compatibility with the laminar airflow system, which gives a lot of flexibility. We did not prefer a footstand because of the large footprint and the limitation in the anaesthesia space. Of course, you also need to park the FlexArm but you have far more freedom of movement and especially the space around the table was decisive. It is fantastic that anaesthesia has the positioning freedom they need.

support. Basically, everyone who plays a role in running the OR was at the table.

The project team answered questions like: what do we want, what is possible in the current situation and what is not, how do we scope, how do we develop the programme requirements, and what is the weight of requirements. This approach enabled everyone to contribute with ideas and needs, like anaesthesia's need for enough space at

Research

What mattered to us is that we wanted Eric Beekmans to be able to use the hybrid OR in all circumstances and for various procedures.

Therefore, we needed the system to comply with the Richtlijn 7 guidelines (Dutch OR airflow certification). We assigned Royal Haskoning to perform a CFD calculation to see the airflow. They mapped this in a simulation study and it appeared that we needed to apply a couple of slats and peripheral facilities to make sure that the flow would come together 20cm below the rail for a decent down flow. With the chosen settings and conditions, the air flows will definitely comply with the RL7 guidelines.

Cooperation

Approach

We involved a very large user group that consisted of OR assistants, anaesthesia staff, physicians, anaesthesiologists, radiology experts, ICT, infection control, and workflow

the head-end for an optimal workflow. It also kept everyone well-informed and aligned.

Maasstad Ziekenhuis room design

Philips played an important role in our project. Besides the support provided during the selection process, they invited us to their headquarters to share their expertise about the air treatment and helped us in performing the simulation study with Royal Haskoning and finding the solution to comply with RL7.

Secondly, they were a very valuable partner in the room design details by drawing all workflows from a clinical perspective.

Study concludes ceilingmounted imaging systems do not affect sterility

Philips and TNO Research (an independent research institute, established by Dutch law) conducted the first study to evaluate the effect of ceiling-mounted imaging systems on colony forming unit (CFU) levels during surgery. The authors concluded that the air quality remains to be far within the thresholds for microbiological air pollution so ceiling-mounted systems have no impact on sterility.

Background

The study investigated the effect of large ceiling-mounted imaging systems combined with undirectional flow (UDF) systems on the air quality during surgery. Floor-mounted systems have also not been studied to date.

The CFU/m3 near the surgical wound and on the instrument table during surgery were measured in four hybrid operating rooms in The Netherlands, where ceiling-mounted

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imaging systems from Philips were used above the patient in their working position.

The results

As shown in Figure 1, when ceiling-mounted imaging systems are used in combination with a large UDF system, there is no impact on sterility. In fact, it is feasible to reach air quality values far below the internationally accepted threshold value of 10 CFU/m3 and

Figure 1. The position of the instrument table can have an influence on the overall cfu/m3 in the hybrid OR.

also far below Philips much lower targets of 5 CFU/m3 for infection-sensitive surgery. In this study, the average value near the surgical wound was 2 CFU/m3 and the average value near the instrument table (when placed directly below the UDF system) was 4.5 CFU/m3.

Read more about the study on www.philips.com/hybridor.

January 2020

Future

Philips Azurion Hybrid OR

Your hybrid OR opens the door to future technology As interventional suites are pressed to do more with less, new solutions are needed to deliver improved care to more patients, while reducing costs, keeping staff healthy and happy, and at the same time enhancing the patient experience.

Here we outline three Philips innovations shaping the future of image guided therapy.

3D device guidance using light

Philips’ Fiber Optic RealShape (FORS) technology sparks a new era in image guidance. This unique technology enables real-time 3D visualisation of the full shape of devices inside the body and this without fluoroscopy.

Following successful pre-clinical trials, Philips has concluded the first-in-human study at the University Medical Center of Utrecht, The Netherlands. The objective was to study the feasibility for using FORS technology in endovascular aortic and peripheral procedures.

According to Joost van Herwaarden, vascular surgeon at University Medical Center of Utrecht, The Netherlands, “FORS appears to be a very promising, revolutionary new technology that has huge potential to improve endovascular procedures”.

Hear more about FORS from the first users: vascularnews.com/fors-technology.

They highlight their current difficulties in conducting image guided procedures, show what the FORS technology enables, share a remarkable moment from the clinical study, and end on their next steps.

Artificial intelligence—a smart assistant in the interventional suite

One of the biggest challenges in the interventional suite for clinicians today is the sheer amount and complexity of data they acquire every day, and the difficulty in deriving meaningful insights from it. This is where artificial intelligence (AI) holds

Fiber Optic RealShape (FORS) technology

January 2020

tremendous promise. With its ability to sift through and extract actionable insights from large amounts of data, AI offers new ways to provide clinical decision support and speed up workflows. AI could help to alleviate the mounting administrative burden in the interventional suite, allowing clinicians to focus more on the procedure and the patient.

FORS appears to be a very promising, revolutionary technology.”

AI offers new ways to speed up workflows.”

Suppose AI is used to automatically track each step of a procedure, log relevant events and actions, and then auto-populate reports with images and measurements acquired during the procedure. A clinician would only have to review, complete, and sign off the pre-populated report at the end of a procedure. AI will also take a growing role in providing real-time clinician decision support. Computer-assisted interpretation of images could go a long a way in further improving accuracy, offering a helping hand

to the clinician.

Augmented reality—a new way of looking at image guided therapy

Another innovation area in image guided therapy is augmented reality (AR). AR has the potential to address a common challenge reported by clinicians in the interventional suite: the need for increased flexibility to move around the patient during a procedure, while still having all relevant patient information in direct view.

This is particularly relevant in procedures such as endovascular repair of aortic aneurysms, where clinicians gain vascular access from both sides of the patient, which frequently leads to compromises in the positioning of the monitors and clinicians who have to strain their necks in order to see images clearly. Imagine having that same information right in front of your eyes, without having to turn your head.

Although still a future concept at this point, it is easy to see how AR technology combined with smart glasses could help clinicians navigate through anatomical structures more accurately—having an impact on quality and efficiency of care, as well as staff experience.

Training, education, and remote assistance are other potential applications of AR. What if you were able to follow a procedure in real time through the eyes of a colleague, and offer specialist advice where needed?

It sounds futuristic, but with AR this could eventually turn into reality.

AR with Hololens

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