Hospital Reports Europe – Improving the Safety and Cost Effectiveness of Neurosurgery Procedures

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SPECIAL REPORT

Improving the Safety and Cost Effectiveness of Neurosurgery Procedures The Impact of Robotics on Stereotactic Surgery Adding Precision to the Neurosurgeon’s Skill Robots in the Theatre Specific Benefits and Wider Returns Infinite Demand Meets Finite Supply

Sponsored by

Published by Global Business Media


Delivering precision through knowledge and expertise

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om Advanced engineering solutions for stereotactic neurosurgery Renishaw is applying precision engineering technology to the challenges of functional neurosurgery. Our aim is to help leading clinicians to enhance the safety and cost-effectiveness of their procedures, whilst improving patient outcomes through accurate delivery of implantable devices. Our range of products are designed to enable surgeons to deliver devices with greater confidence and accuracy relative to targeted brain anatomy. We are also working with a number of medical technology and biotech companies on the development and optimisation of next-generation drug delivery systems for the treatment of neurodegenerative, neuro-oncology and orphan diseases.

For more information visit www.renishaw.com/neuro

Renishaw plc Wotton Road, Charfield, Wotton-under-Edge, Gloucestershire, GL12 8SP, United Kingdom T +44 (0)1453 524524 F +44 (0)1453 524901 E neuro@renishaw.com

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IMPROVING THE SAFETY AND COST EFFECTIVENESS OF NEUROSURGERY PROCEDURES

SPECIAL REPORT

Improving the Safety and Cost Effectiveness of Neurosurgery Procedures The Impact of Robotics on Stereotactic Surgery Adding Precision to the Neurosurgeon’s Skill

Contents

Robots in the Theatre Specific Benefits and Wider Returns Infinite Demand Meets Finite Supply

Foreword

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John Hancock, Editor

The Impact of Robotics on Stereotactic Surgery

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Stuart Campbell, Clinical Sales Development Manager for the Neurological Products Division, Renishaw plc Sponsored by

Published by Global Business Media

Published by Global Business Media Global Business Media Limited 62 The Street Ashtead Surrey KT21 1AT United Kingdom Switchboard: +44 (0)1737 850 939 Fax: +44 (0)1737 851 952 Email: info@globalbusinessmedia.org Website: www.globalbusinessmedia.org Publisher Kevin Bell Business Development Director Marie-Anne Brooks Editor John Hancock Senior Project Manager Steve Banks Advertising Executives Michael McCarthy Abigail Coombes Production Manager Paul Davies For further information visit: www.globalbusinessmedia.org

The History of the Talairach Stereotactic Frame The Development of Deep Brain Stimulation (DBS) The Use of Robotics in DBS Improving Patient Experience with Surgical Software Renishaw plc

Adding Precision to the Neurosurgeon’s Skill John Hancock, Editor

What Conditions Do Neurosurgeons Treat? The Application of Stereotactic Surgery Robot Technology Adds Further Capabilities and Refinement

Robots in the Theatre

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Camilla Slade, Staff Writer

Neurosurgery: A Challenging and Satisfying Specialty Risks Associated with Neurosurgery What Robots Can Deliver

Specific Benefits and Wider Returns

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Peter Dunwell, Medical Correspondent

Robots in Surgery: Benefits and Challenges Robots and Stereotactic Surgery Specific Benefits and the Wider Picture

Infinite Demand Meets Finite Supply The opinions and views expressed in the editorial content in this publication are those of the authors alone and do not necessarily represent the views of any organisation with which they may be associated. Material in advertisements and promotional features may be considered to represent the views of the advertisers and promoters. The views and opinions expressed in this publication do not necessarily express the views of the Publishers or the Editor. While every care has been taken in the preparation of this publication, neither the Publishers nor the Editor are responsible for such opinions and views or for any inaccuracies in the articles.

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John Hancock, Editor

A Specialty Under Pressure Faster Work but Better Work A System That Works for the Surgeon and Works for the Patient The Future for Stereotactic Robotics in Neurosurgery

References 14

© 2018. The entire contents of this publication are protected by copyright. Full details are available from the Publishers. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical photocopying, recording or otherwise, without the prior permission of the copyright owner.

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IMPROVING THE SAFETY AND COST EFFECTIVENESS OF NEUROSURGERY PROCEDURES

Foreword

O

nce the stuff of science fiction, in just a

can provide stable, precise spatial positioning of

quarter of a century, surgical robotics

surgical tools used during DBS procedures and their

have progressed from rare and specialised

neuroinspire™ software, to create digital, interactive

applications using large and expensive equipment

3D models of the brain.

to a wide range of capabilities using much more

This article is followed by a brief review of

manageable equipment and able to work in the

neurosurgery, the conditions that a neurosurgeon

most delicate of surgical applications such as are

might be called upon to treat, an overview of

found in neurosurgery. Given the current pace of

stereotactic surgery and an overview of surgical

development and the increasing possibilities that

robotics plus how these technologies can enhance

are presenting themselves, this is a very good

the projection of a neurosurgeon’s skills. Next,

time to take a look at robotic neurosurgery and

Camilla Slade considers the different neurosurgical

its very close companion technology, stereotaxy

procedures, the risks that can be associated with

– together, we call them stereotactic robotic

neurosurgery and how this is leading to a growing

neurosurgery. So, in this Report, we have taken

requirement for the capabilities that robots can

a closer look at stereotactic robotics, where they

deliver. Peter Dunwell then looks at how stereotactic

have evolved from, what they do, the drivers that

robots can improve consistency and accuracy in

are behind the development of this technology,

neurosurgery, the clear benefits that offers and, in

why they are useful and where the next stages of

particular, how it can deliver better patient outcomes

development might take them.

for a wider range of neurological conditions. Finally,

The Report opens with an article by Stuart Campbell,

we review some of the drivers that are making robots

Clinical Sales Development Manager for Neurological

into an ever more realistic solution, the importance

Products Division of global engineering company,

of technology in improving every dimension of

Renishaw, which looks at the impact of robotics

neurosurgery, what should be considered when

on stereotactic surgery from its early beginnings

selecting a system and what is the future outlook in

pioneered by Jean Talairach in Paris in 1938, up to

this very exciting field of surgical technology.

modern neurological products such as Deep Brain Stimulation (DBS). The article goes on to describe Renishaw’s neuromate® stereotactic robot which

John Hancock Editor

John Hancock, an Editor of Hospital Reports Europe, has worked in healthcare reporting and review for many years. A journalist for more than 25 years, John has written and edited articles, papers and books on a range of medical and management topics. Subjects have included management of long-term conditions, elective and non-elective surgery, wound management, complex health issues, Schizophrenia, health risks of travel, local health management and NHS management.

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IMPROVING THE SAFETY AND COST EFFECTIVENESS OF NEUROSURGERY PROCEDURES

The Impact of Robotics on Stereotactic Surgery Stuart Campbell, Clinical Sales Development Manager for the Neurological

Delivering precision

Products Division, Renishaw plc

through knowledge and expertise

P

SYCHIATRIST, JEAN Talairach arrived at Sainte Anne Hospital, Paris, in 1938. At the time, the 28-year-old had a small amount of formal training in neurosurgery but, after being encouraged by the hospital’s resident neurosurgeon, Marcel David, he switched disciplines. Talairach spent the next 68 years of his life addressing the common challenges faced in contemporary neurosurgery. His insight drove innovation in the field and, to this day, his procedures and techniques are replicated in operating rooms across the world. Here, Stuart Campbell, Clinical Sales Development Manager for the Neurological products Division of global engineering company Renishaw, explores the impact that stereotactic surgery has had on the medical industry.

The History of the Talairach Stereotactic Frame In the 1940s, when Talairach had only just started practising neurosurgery, frontal lobotomy was routinely used as a treatment for mental health conditions. Antipsychotic medicine was not yet available, so this extremely invasive procedure was one of the few options available to medics. Neurosurgeons needed a way to safely and accurately target structures located deep in the brain, so Talairach devised a frame that could be fitted to the patient’s head, acting as a reference point when targeting structures and guiding surgical tools along a pre-planned trajectory. This process of mapping the brain is now routinely used in the process of stereotaxy, with surgeons regularly using it in the treatment of neurological conditions such as epilepsy and Parkinson’s disease. However, the technology used to carry out the process has advanced significantly. The prototype of Talairach’s frame for stereotactic neurosurgery was knocked together by the hospital’s maintenance man. It featured a rectangular double-layer grid, perforated with holes at regular intervals. It was these

holes that would guide surgical equipment during procedures. With computed tomography (CT) and magnetic resonance imaging (MRI) not yet available, Talairach and his team were dependent on X-rays for pre-surgical imaging. Positive-contrast dye would be injected into the blood vessels in the brain to ensure that they were visible. By keeping the frame in place during the X-ray, surgeons would be able to identify the precise location of features of interest with reference to the grid. Modern neurosurgical products, such as those designed by Renishaw, build on the principals of discipline and precision that defined Talairach’s work. Assisted by technology, neurosurgeons have been able to decrease surgery time and increase patient safety during surgical procedures, such as Deep Brain Stimulation (DBS), biopsies, neuroendoscopy and Stereoelectroencephalography (SEEG).

The Development of Deep Brain Stimulation (DBS) At around the same time that Talairach started practising neurosurgery, it was found that lesioning, or destroying, specific areas in the brain could help treat certain movement disorders. When areas of the brain involved in the disorder were lesioned, symptoms often improved. Soon after these findings were tried and tested, lesioning surgeries became a standard treatment for reducing motor control problems caused by conditions such as Parkinson’s disease. Unfortunately, lesioning was not always effective in reducing negative symptoms and often resulted in damaging side effects for the patient. One of the main problems with this type of surgery is that the effects cannot be undone – a lesioned brain structure is permanently destroyed. As a result, unwanted side effects are usually irreversible. In the late 1980s, a discovery was made that offered a safer alternative to lesioning surgeries. Medics found that the same effects could be achieved by stimulating the tissue with harmless pulses of electricity. Like drug therapies, surgeons

Advanced engineering solutions for stereotactic neurosurgery Renishaw is applying precision engineering technology to the challenges of functional neurosurgery. Our aim is to help leading clinicians to enhance the safety and cost-effectiveness of their procedures, whilst improving patient outcomes through accurate delivery of implantable devices.

For more information visit www.renishaw.com/neuro

Renishaw plc Wotton-under-Edge, Gloucestershire GL12 8JR United Kingdom T +44 (0)1453 524524 F +44 (0)1453 524901 E neuro@renishaw.com

www.renishaw.com

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IMPROVING THE SAFETY AND COST EFFECTIVENESS OF NEUROSURGERY PROCEDURES

This process of mapping the brain is now routinely used in the process of stereotaxy, with surgeons regularly using it in the treatment of neurological conditions such as epilepsy and Parkinson’s disease

could tailor the electrical stimulation to match the exact needs of each patient. On top of this, the electrical stimulation could be localised, so only intended parts of the brain were treated. DBS treatments were tested on an experimental basis for several years, with positive treatment results continuously being observed. In 2002, the use of DBS for conditions such as Parkinson’s disease was approved by the Food and Drug Administration (FDA).

The Use of Robotics in DBS DBS is a technique that relies on the precise placement of electrodes and targeting structures deep in the brain. Stereotactic procedures, such as DBS, can be hampered by inaccurate positioning. This can be caused by several factors, of which human error is only one. Using a stereotactic robot reduces the degree of error by precisely positioning the surgical tools to pre-programmed co-ordinates with a high degree of accuracy and reproducibility. While the neurosurgeon retains complete control during the procedure, they are able to accurately manoeuvre the articulated robotic arm, which serves as a solid base for mounting and manipulating surgical tools. During DBS procedures, pre-surgical preparation is carried out and involves fitting a frame to the patient’s head to act as a reference system. This is followed by taking a combination of MRI and CT scans and pre-operative X-rays. This data is used to carefully plan the trajectories, avoiding sulci and blood vessels, to take the safest path to the target. The process of identifying the patient’s position within 3D space is known as patient registration.

Renishaw’s neuromate® stereotactic robot can provide stable, precise spatial positioning of surgical tools. Using the neurolocate™ attachment in partnership with intraoperative imaging technology, patients can be registered in theatre, reducing the overall time spent on the procedure. Stereotactic robots, such as Renishaw’s neuromate®, can then be used to position the drill, with which the surgeon creates a burr hole. The robot helps ensure that the burr hole is accurately positioned, orientated and centred on the trajectory axis. Stimulation electrodes are implanted next, with the robot positioned so that the tip of the electrode enters the burr hole along the planned trajectory. The trajectory is not limited in the same way as a conventional stereotactic frame, since the robotic tool can be orientated in any direction through the burr hole. Renishaw’s neuroguide™ can also be integrated into existing practice. This enables surgeons to opt for a DBS procedure with very precise lead placement accuracy and efficient procedure times. Once in position at the target location, the patient is woken from the general anaesthetic and the procedure continues under local anaesthetic. Each of the inner micro-electrodes is tested at different positions, with the robot and macroelectrode fixed in place. This is facilitated by moving the inner electrode along the trajectory with a third-party micro-drive mounted on the tool holder of the robot. The electrophysiological readings allow the surgeon to find the optimum location to stimulate, while minimising side effects. In addition to DBS, stereotactic robots can also be used with different tools to perform biopsies and the implantation of electrodes for SEEG monitoring, which is used to treat epilepsy.

Improving Patient Experience with Surgical Software

RENISHAW NEUROMATE® STEREOTACTIC ROBOT

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As well as the introduction of stereotactic robots, neurosurgeons have also progressed to using surgical software, such as Renishaw’s neuroinspire™ software, to create digital, interactive 3D models of the brain. With these models, surgeons can explore trajectories, experiment with tools and optimise the surgical procedure in advance of the patient entering the operating theatre. Surgical planning software provides the tools that assist surgeons with the planning of most stereotactic procedures. In particular, Renishaw’s neuroinspire™ software provides neurosurgeons with an easy-to-use platform for target identification and trajectory planning. The software fuses MRI and CT datasets into a 3D volume, enabling neurosurgeons to explore the


IMPROVING THE SAFETY AND COST EFFECTIVENESS OF NEUROSURGERY PROCEDURES

Delivering precision through knowledge and expertise

RENISHAW NEUROINSPIRE™ FOR PLANNING SEEG PROCEDURES

best available approach to the target, avoiding key anatomy and blood vessels. Trajectories are defined by the use of a target and entry point. Neurosurgeons can select their chosen electrode from a drop down catalogue and can include a safety zone to reduce risk of collision with key anatomy. Using a virtual electrode also allows neurosurgeons to align the contact tip with the target. The path that the trajectory takes through the brain can be checked using reconstructed surgeon-eye and trajectory views. Neuroinspire™ software allows for surgeries to be planned well in advance of the procedure, reducing surgery time and improving patient experience. The techniques pioneered by Talairach in the gothic, cathedral-like operating room of Sainte Anne Hospital formed some of the central tenets of modern neurosurgery. Despite initially not having a recognised background, he is now widely credited as the father of imageguided stereotaxy. Advancements in technology have enhanced the procedure and, today, stereotactic surgeries improve the lives of thousands of patients around the world. As for Talairach, he published his final stereotactic atlas at the age of 82 and continued to work for a number of years after.

Renishaw plc UK-based Renishaw is a world leading engineering technologies company, supplying products used for applications as diverse as jet engine and wind turbine manufacture, through to dentistry and brain surgery. It has over 4,000 employees located in the 35 countries where it has wholly owned subsidiary operations. For the year ended June 2017 Renishaw recorded sales of £536.8 million of which 95% was due to exports. The company’s largest markets are China, the USA, Japan and Germany. Throughout its history Renishaw has made a significant commitment to research and development, with historically between 14 and 18% of annual sales invested in R&D and engineering. The majority of this R&D and manufacturing of the company’s products is carried out in the UK. The Company’s success has been recognised with numerous international awards, including eighteen Queen’s Awards recognising achievements in technology, export and innovation.

Further information at www.renishaw.com

Advanced engineering solutions for stereotactic neurosurgery Renishaw is applying precision engineering technology to the challenges of functional neurosurgery. Our aim is to help leading clinicians to enhance the safety and cost-effectiveness of their procedures, whilst improving patient outcomes through accurate delivery of implantable devices.

For more information visit www.renishaw.com/neuro

In 2002, the use of DBS for conditions such as Parkinson’s disease was approved by the Food and Drug Administration (FDA).

Renishaw plc Wotton-under-Edge, Gloucestershire GL12 8JR United Kingdom T +44 (0)1453 524524 F +44 (0)1453 524901 E neuro@renishaw.com

www.renishaw.com

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IMPROVING THE SAFETY AND COST EFFECTIVENESS OF NEUROSURGERY PROCEDURES

Adding Precision to the Neurosurgeon’s Skill John Hancock, Editor Neurosurgery is a delicate process; so the use of stereotactic surgery and the arrival of robots will add welcome tools to the surgeon’s capability

There is another technology whose development has added further capability to stereotactic surgery and to the precision with which a surgeon can operate: that technology is robotics

O

F ALL the disciplines whose skills are needed when things go wrong with us, neurosurgery is probably the one invested with most wonder by the population at large. The term ‘Brain Surgery’ has come to epitomise the deployment of extreme skill.

What Conditions Do Neurosurgeons Treat? But what do neurosurgeons actually do? “[They] diagnose, assess and perform surgery to treat disorders of the nervous system. They operate on the central nervous system (brain and spinal cord) and the peripheral nervous system which can involve any area of the body.” There wouldn’t be much to add to Health Education England’s summary of the function,1 but neurosurgeons treat a range of conditions and the guide continues to list some of the main ones: • Tumours of the brain, spine and skull; • Trauma to the head and spinal cord; •D egenerative spinal conditions and prolapsed discs; • Cerebral (brain) aneurysms and strokes; • Epilepsy; • Infections; •M ovement disorders such as Parkinson’s disease; • Certain psychiatric disorders; • Congenital conditions such as spina bifida; •C onditions that affect cerebro-spinal fluid flow such as hydrocephalus; •P ituitary tumours and neuroendocrine disorders. As can be seen, these are largely physical conditions affecting the brain and nervous system. While psychiatric disorders are listed, neurosurgery is not commonly used to treat mental health problems, but there might be limited cases of severe depression, severe anxiety disorders or severe obsessive compulsive disorder (OCD) where neurosurgery could be tried if other treatments have failed2.

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As a speciality, neurosurgery is relatively young. The Royal College of Surgeons3 explains that “The specialty developed in the first half of the twentieth century through the treatment of head and brain injuries. Subsequent advances in technology, intensive care and sophisticated non-invasive procedures have widened the scope of neurosurgical practice to include oncology services and neurovascular as well as trauma.” The paper continues to list the sub-specialities that have developed in the discipline.

The Application of Stereotactic Surgery One surgical development that neurosurgery has used to a significant degree is stereotaxy or stereotactic surgery. For this, Wikipedia4 offers a neat definition, “Stereotactic surgery or stereotaxy is a minimally invasive form of surgical intervention which makes use of a threedimensional coordinate system to locate small targets inside the body and to perform on them some action such as ablation, biopsy, lesion, injection, stimulation, implantation, radiosurgery (SRS), etc.” This has proved particularly efficacious in neurosurgery where, because of the nature of where the surgeon needs to operate, millimetres can be the difference on which a successful outcome turns. So, coming to the specific application of stereotactic brain surgery, UR Medicine5 tells us that, “A stereotactic brain surgery is a surgical procedure where lesion, frequently a brain tumor, is removed with assistance of image guidance, that is previously obtained images (usually an MRI) are used to guide the surgeon to the exact location of the lesion to facilitate as accurate a pathway through the brain and safe removal of as much abnormal tissue as possible while leaving normal, healthy brain relatively intact.” So stereotaxy in neurosurgery involves the construction and application of a framework that fits over the head and includes guide


IMPROVING THE SAFETY AND COST EFFECTIVENESS OF NEUROSURGERY PROCEDURES

Delivering precision through knowledge and expertise

holes that have been lined up to ensure that the instrument, laser or radiosurgery beam is directed with, literally, engineered accuracy to reach the part that has to be treated or removed, but not damage any of the parts that have to be passed in order to reach the operating site. It is a tool that enables a neurosurgeon to apply their skills with maximum precision to achieve optimum results. But there is another technology whose development has added further capability to stereotactic surgery and to the precision with which a surgeon can operate: that technology is robotics.

Robot Technology Adds Further Capabilities and Refinement Robots have colonised a host of workspaces and their progress is predicted to have them autonomously performing many of the routine tasks used in manufacturing but also, because of their extreme precision, robots are especially suited as a tool to add millimetre precision to a surgeon’s knowledge and skill. And, combined with Stereotaxy, robots can revolutionise the speed and quality of a surgical procedure and greatly extend the scope of what is possible. “In SEEG [stereoelectroencephalography] we place up to 20 intracerebral electrodes in order to identify the epileptogenic zone and map eloquent structures. Thanks to the use of the [robotic] system, every target can be reached with a combination of speed and submillimetric accuracy.” Was how Dr. Francesco Cardinale, Neurosurgeon, Ospedale Niguarda Ca’Granda, Milan, Italy, described the use of robotics. Emphasising the additional scope that robotics can offer. Mr. David Sandeman, Consultant neurosurgeon, Southmead Hospital, Bristol, UK added, “The precision of robotic guided SEEG

has revolutionised surgery to cure epilepsy, allowing us to offer cures to a whole new cohort of patients.” (author’s italics). Notwithstanding those comments, as recently as May 2017, the Journal of Neurosurgery6 reported that, “to date neurosurgery has not seen as broad an adoption of robotic techniques.” continuing to add,“ Several aspects of our subspecialty lend themselves to the need and implementation of robotics…” The journal then lists the ‘aspects’ to which it refers as: 1. T he rich history of neurosurgical innovation in stereotaxy and navigated localization; 2. T he tight anatomical confines that are armoured by and oriented very specifically to bony structures; 3. The microsurgical nature of our procedures; 4. The highly technical nature of the field; 5. T he growth and need for growth in minimally invasive neurosurgery; and 6. A culture that adopts and embraces new technology with optimism. But, perhaps the strongest expression of what a robot can achieve in neurosurgery can be found in the title of an article in Futurism, Health & Medicine7, “This Robot Completes a 2-Hour Brain Surgery Procedure in Just 2.5 Minutes”. The May 2017 statement is based on research at the University of Utah that was published in the journal Neurosurgical Focus. With neurosurgery in particular, the consequences of straying from a very tightly defined path to the treatment site and/or of any level of collateral damage are acute. In that context, any technology solution will be welcome.

Advanced engineering solutions for stereotactic neurosurgery Renishaw is applying precision engineering technology to the challenges of functional neurosurgery. Our aim is to help leading clinicians to enhance the safety and cost-effectiveness of their procedures, whilst improving patient outcomes through accurate delivery of implantable devices.

For more information visit www.renishaw.com/neuro

Renishaw plc Wotton-under-Edge, Gloucestershire GL12 8JR United Kingdom T +44 (0)1453 524524 F +44 (0)1453 524901 E neuro@renishaw.com

www.renishaw.com

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IMPROVING THE SAFETY AND COST EFFECTIVENESS OF NEUROSURGERY PROCEDURES

Robots in the Theatre Camilla Slade, Staff Writer Machines that deliver a surgeon’s skills more precisely and consistently than any human hand or eye could do

Neurosurgery is a fascinating specialty that offers the prospect of curing patients with a wide range of benign pathologies as well as improving and prolonging the quality of life for patients with debilitating neurological diseases

Neurosurgery: A Challenging and Satisfying Specialty

Risks Associated with Neurosurgery

From John Hancock’s article we know that neurosurgeons prevent, diagnose and treat disorders of the nervous system, including the brain, spinal cord and peripheral nerves. Not my words but from the BMA8, which continues to ask why would a surgeon opt for this specialty, and to answer itself that it might be “the variety, every day brings a challenge.” and that, with the constant improvement in our knowledge of the brain and central nervous system, it is possible to see immediate results. The BMJ9 offers a useful list of the main subspecialties…

Of course, the over-riding concern for any surgeon is patient safety and here the statistics suggest that anything that improves performance in that area would be welcome. While there are no statistics for neurosurgery specifically, The Guardian11 reported in December 2016 that, “after changing the way it collates data in May 2015 regarding incidents in which patient safety is endangered, NHS England says that 30 surgical errors and 19 wrong-site surgeries occurred in 2015-16, as did another 691 cases of a ‘surgical/ invasive procedure incident’”. There is always a risk of complications occuring during an operation and not all can be attributed to error, but the less, the better. The NHS England, Clinical Human Factors Group paper ‘Never’12, sets out a number of typical failures including a neurosurgical case where ‘A patient had a surgical implant inserted into his spine in the wrong joint – one below where it was supposed to be.’ Of particular interest for us is the reason for the error. “A metal device was held above the spine as a marker for identifying the correct level under X-ray control but, once the X-ray machine was removed, the device was not secured to the patient/bone.” It shows how critical it is that placing of any procedure or insert is controlled with the most accuracy possible. Even stereotactic surgery is not immune from error. NCBI Resources, ‘Pitfalls in precision stereotactic surgery’13 reports that, “Precision is dependent on minimizing errors at every step of the stereotactic procedure.” One area of risk in stereotactic surgery is distortion of the MRI images used to visualise intracranial structures on which the report suggests, “nearcomplete distortion correction can be reliably achieved with modern machines.”

• Neuro-oncology; • Neurovascular surgery; • Paediatric neurosurgery; • Skull base surgery; • Spinal surgery; • Traumatology. … as well as a more emotional reason for becoming a neurosurgeon, “Neurosurgery is a fascinating specialty that offers the prospect of curing patients with a wide range of benign pathologies as well as improving and prolonging the quality of life for patients with debilitating neurological diseases.” But neurosurgery is not for the faint-hearted: it is very demanding when working, with the need for dexterity, co-ordination and, given the length of some procedures, stamina, plus with the need to keep up to date with a lot of developments such as the latest technologies applicable to the specialism. John Hancock listed the conditions for which neurosurgery might be applicable and some of the subspecialties are listed above, but there is a further dimension to this specialty – the different types of surgery. While there won’t be space to list them all, just the different types of brain surgery illustrate the complexity with craniotomy, biopsy, minimally invasive endonasal endoscopic surgery, minimally invasive neuroendoscopy and deep brain stimulation. For full details, go to Healthline10, ‘Brain Surgery’.

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What Robots Can Deliver Those ‘modern machines’ would include robots. The British Journal of Anaesthesia’s, ‘The evolution of robotic surgery: surgical and anaesthetic aspects’14 reports that, “Robotic


IMPROVING THE SAFETY AND COST EFFECTIVENESS OF NEUROSURGERY PROCEDURES

Delivering precision through knowledge and expertise

surgery pushes the frontiers of innovation in healthcare technology towards improved clinical outcomes.” The abstract continues to outline the evolution of robotic surgical platforms, including stereotactic. Perhaps it is no surprise, given that healthcare systems today are under ever greater pressure from several sides (cost, time, litigation risk, number of patients, available therapies and treatments…), that robots are a growing presence in developed healthcare systems. It isn’t that they can replace a surgeon’s skills; it is that they can improve the deployment and effectiveness of those skills by eliminating inconsistencies. UK-RAS (Robotics and Autonomous Systems) 2016 report, ‘Surgical Robotics: The Next 25 Years’15 speaks to the key benefits of this developing sector, “Medical robots… represent one of the fastest growing sectors in the medical devices industry. One of the key areas of medical robotics is the development of surgical robots for minimally invasive surgery and microsurgery.” It is that finesse that robots contribute that enables surgeons to tackle procedures that would be problematical with human deployment of instruments whereas robots can be programmed to work with unshakable millimetre accuracy, enabling surgeons to direct operations requiring a finesse that might have once seemed unfeasible. The report continues to address the cost issue, inasmuch as robots are expensive

machines requiring expensive software. The solutions include concentration of certain capabilities in regional centres which would certainly be in line with the way the UK NHS is currently going. It also looks into a future where the Science Fiction concept of machines going into the body (‘Fantastic Voyage’ – 1966) will become a reality. Like many technology developments, robotics in all fields, including surgery, are evolving at an exponential rate and, looking at that cost concern, MediSens16 suggests “Robotic surgery is still very expensive which can make it prohibitive for many hospitals and health-care centres. Studies have shown, however, that robotic surgery cuts down on the trauma and healing time for specific applications… [with] minimal invasiveness for the patient, enhanced microsurgery and precision capabilities for the surgeon, and cost optimisation for the healthcare system, due to patients’ shorter recovery time.” In 2015, the authors of ‘Robotics in Neurosurgery: Evolution, Current Challenges and Compromises’17 wrote, “Robotic-assisted surgery has revolutionised several surgical fields, yet robotic-assisted neurosurgery is limited by available technology.” That might have been true as recently as 2015 but, from a combination of need and the availability of rapidly developing robotic systems, it is unlikely to be the case in the future.

Advanced engineering solutions for stereotactic neurosurgery Renishaw is applying precision engineering technology to the challenges of functional neurosurgery. Our aim is to help leading clinicians to enhance the safety and cost-effectiveness of their procedures, whilst improving patient outcomes through accurate delivery of implantable devices.

For more information visit www.renishaw.com/neuro

Renishaw plc Wotton-under-Edge, Gloucestershire GL12 8JR United Kingdom T +44 (0)1453 524524 F +44 (0)1453 524901 E neuro@renishaw.com

www.renishaw.com

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IMPROVING THE SAFETY AND COST EFFECTIVENESS OF NEUROSURGERY PROCEDURES

Specific Benefits and Wider Returns Peter Dunwell, Medical Correspondent When it comes to the need for high precision procedures, robots and stereotaxy make a formidable partnership

The improvement of accuracy in stereotactic procedures, the close integration with imaging devices and the use of hands-on surgery concept will greatly improve the overall quality of computer integrated neurosurgery

R

OBOTS HAVE been familiar participants in the workplace for decades. As long ago as 1978, Fiat advertised its Strada model as “Handbuilt by Robots”. This might seem some way off the subject of this paper but it is actually very pertinent. The reason that Fiat used the fact that their car was built by robots was because the firm had, at the time, an appalling record for poor build quality. Poor quality that the public assumed arose from a careless workforce and that stopped motorists from buying the cars. Whether or not that was true of the workforce, by focusing on the fact that the new model was built by robots, Fiat was able to imply that there would be no quality problems because robots cannot be distracted, do not get tired or bored, and follow their processes with 100% precision and consistency. Quality and consistency, it saved the business and if those attributes are important when building a car, they’re even more important in the field of neurosurgery.

Robots in Surgery: Benefits and Challenges The first application of a robot in surgery happened in 1985, and it was in support of a neurosurgical procedure. Today, the most common systems in robotic surgery are dependent systems, where the surgeon retains full control of the surgical instruments. In 2011, Springer Business Books ‘Robotics in Neurosurgery’18 concluded, “Use of robots in surgery, especially in neurosurgery, has been a fascinating idea since the development of industrial robots. Using the advantages of a robot to complement human limitations could potentially enhance surgical possibilities, other than making it easier and safer.” According to ‘Robotics in Neurosurgery: Evolution, Current Challenges and Compromises’19 “The use of robotic systems in neurosurgery may help increase surgical accuracy and allow surgeons to perform more complicated operations. However, our current 10 |WWW.HOSPITALREPORTS.EU

robotic technology is limited due in part to anatomical challenges, so other specialty areas have grown much faster than neurosurgery… but researchers continue to work on creating a believable virtual environment that can replicate actual surgeries.” That note of caution was sounded in 2015 and since then, there have been significant advances that will enable robots to deliver the promise of more complicated operations while they have also overcome the challenges cited.

Robots and Stereotactic Surgery Often, the best development for a technology is when it is harnessed with another technology in a process known as convergence. We have seen it in our daily lives with devices that take photographs, play music, keep calendars, help to browse the Internet, send emails and, by the way, you can also make phone calls on them. For surgical robots, the technology with which they have been successfully partnered in neurosurgery is the stereotactic frame. “Precision is the ultimate aim of stereotactic technique. Demands on stereotactic precision reach a pinnacle in stereotactic functional neurosurgery.“ That’s the conclusion of NCBI’s paper ‘Pitfalls in precision stereotactic surgery’20. But, as we’ve said before in this Report, the intention is to use robotics to enhance a surgeon’s performance rather than to replace them, something often called cooperative control. In ‘Future Trends in Robotic Neurosurgery’21, the authors cite, “The ongoing neurosurgical research project at the Johns Hopkins University (JHU) is a good example of the cooperative control concept. The system is based on a modified NeuroMate surgical robot that is capable of helping and increasing the performance of human surgeons.” And the same paper highlights that partnership between surgical robotics and the stereotactic frame, confirming that, “the improvement of accuracy in stereotactic procedures, the close integration


IMPROVING THE SAFETY AND COST EFFECTIVENESS OF NEUROSURGERY PROCEDURES

Delivering precision through knowledge and expertise

with imaging devices and the use of hands-on surgery concept will greatly improve the overall quality of computer integrated neurosurgery.” So what is this stereotactic procedure? The authors of the ‘Review of Robotic Technology for Stereotactic Neurosurgery’22 summed it up beautifully, “Stereotaxis has been derived from the Greek, meaning a ‘three-dimensional, orderly arrangement’, which is based on the principle that a volume like the brain can be mapped according to a specific coordinate system using precise measurements… The ability to correlate anatomical data with objective spatial mapping has opened the way to minimally invasive and safer structural stereotaxy, also known as keyhole neurosurgery” In the paper’s conclusion, the authors confirm the positive contribution already made by robots in neurosurgical practice, “The robotic solutions which are currently available for stereotactic surgeries can easily enhance the surgeons’ performance…” adding that robotic solutions, “are becoming easier and more intuitive to use as this technology evolves.”

Specific Benefits and the Wider Picture Looking at one more frequently used neurosurgical procedure, Karger ‘Review on Factors Affecting Targeting Accuracy of Deep Brain Stimulation Electrode Implantation between 2001 and 2015’23 reports, “Deep brain stimulation

(DBS) is an established therapy for the treatment of medication-refractory movement disorders like Parkinson’s disease. In this treatment, programmed electrical pulses sent from the implanted electrode are used to modulate the activities of target neurons located deep in the brain… Effective stimulation of deep brain targets depends on the accurate implantation of the DBS electrode.” And in the paper’s conclusion, “Accurate implantation of the DBS electrode into the brain is of greatest importance for effective stimulation.” All of these papers and articles point in the same direction, precision and consistency are critical elements in successful outcomes for neurosurgery and it has been well established that robots have these attributes to a very high degree. These days, any development has to contribute to the wider picture: the NHS and other healthcare systems are under pressure. This arises from the success of being able to treat many more conditions and the growing size of the population, which increases demand to be set against the finite resources on which the system can draw. The Nuffield Trust says, “Reducing the pressure on hospital bed capacity is one of the key challenges currently facing the NHS… a more effective way to contain the growing demand for beds may be to focus on reducing length of hospital stay.” In that context, robots capability to perform less intrusive and more precise operations look like a very good contributor to those shorter hospital stays.

Advanced engineering solutions for stereotactic neurosurgery Renishaw is applying precision engineering technology to the challenges of functional neurosurgery. Our aim is to help leading clinicians to enhance the safety and cost-effectiveness of their procedures, whilst improving patient outcomes through accurate delivery of implantable devices.

For more information visit www.renishaw.com/neuro

Renishaw plc Wotton-under-Edge, Gloucestershire GL12 8JR United Kingdom T +44 (0)1453 524524 F +44 (0)1453 524901 E neuro@renishaw.com

www.renishaw.com

WWW.HOSPITALREPORTS.EU| 11


IMPROVING THE SAFETY AND COST EFFECTIVENESS OF NEUROSURGERY PROCEDURES

Infinite Demand Meets Finite Supply John Hancock, Editor Selecting a Stereotactic Robotic solution to help address a growing demand for neurological surgical services

Current developments in surgical robotics aim to reduce some procedures in brain surgery by 50 times; i.e. reduce a current 2 hour procedure to two and a half minutes

A Specialty Under Pressure As with every aspect of the National Health Service, neurosurgery is a discipline under pressure and for all the same reasons of increasing demand having to be met from finite resources. The Society of British Neurological Surgeons has assembled some figures to illustrate the pressures on neurosurgical services in Britain24. In essence, they tell us that, for a population of just under 63 million, in one year there are likely to be just under 63,000 neurosurgical admissions to hospital resulting in some 43,500 operations. That’s 379 admissions and 262 operations for every neurosurgical consultant. By any reckoning, this adds up to pressure. For instance, the standard recommended in Safe Neurosurgery 2000 for annual operations per consultant was 180-250. One way in which this quart of work could be safely fitted into the pint pot of time available would be to reduce the times of operations or of procedures within those operations.

Faster Work but Better Work Futurism25 in 2017 suggested that current developments in surgical robotics aim to reduce some procedures in brain surgery by 50 times; i.e. reduce a current 2 hour procedure to two and a half minutes. The possibilities were explored in the ‘Review of Robotic Technology for Stereotactic Neurosurgery’26 which suggested that robots would be able to improve times and outcomes in a number of ways by reducing the numbers of steps in each procedure and because their millimetre precision and immunity from fatigue ensures absolute steadiness and increases the possibilities achievable with surgery. Another consideration is the growing trend to litigation when patients feel they have a grievance. Use of stereotactic robotics would reduce the likelihood of a procedure not being performed to plan.

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A System That Works for the Surgeon and Works for the Patient Semantic Scholar27 confirms that, “The quality of health care is ultimately judged by the impact of specific health services on the patient’s health status. Improving quality involves identifying and using health services that, when properly executed, produce the greatest improvement in health status.” And, also Semantic Scholar28 but in a different place, “Robotic-assisted neurosurgery may help increase accuracy and allow surgeons to perform more complicated operations.” The point is that, a system that can enable the surgeon to perform procedures that he or she would find difficult relying just on a steady hand will extend the range of feasible treatments and that will add significantly to patient comfort. Similarly, a system that can consistently repeat a procedure with millimetre precision will also add to comfort and will enhance patient safety. Stereotactic robots have been shown to be able to achieve previously difficult to impossible procedures and to offer greater precision than manual only operation. So, what considerations should be borne in mind when choosing a stereotactic robot solution? These days, cost has to always be the first consideration because, much as it might not be palatable, every institution has to work within a budget. However, while the initial cost of robots and their software is high, there are steps being taken to reduce those costs and, time will also bring down costs as development expenses are covered. Also, any initial cost should be offset against the savings that will follow from the time saving, better outcomes in terms of patient satisfaction, shorter hospital stays, reduced error rates with the concomitant reduction in litigation costs and that indefinable value, greater public trust. Other considerations


IMPROVING THE SAFETY AND COST EFFECTIVENESS OF NEUROSURGERY PROCEDURES

Delivering precision through knowledge and expertise

would include ease of mobility of the robotic device and its size, i.e. its impact on access for the human surgeon. Throughout this paper the matters of precision and consistency have been mentioned and they are both important considerations in the selection of a device. Reliability is also an important consideration, in the context of being able to deliver any of the benefits of stereotactic robotics, plus ease of use – the easier it is to use, the more likely that it will be used properly.

The Future for Stereotactic Robotics in Neurosurgery Notwithstanding that stereotactic robotic neurosurgery is already futuristic enough, no development of this nature should stand still. Whatever benefits any technology might bring to patients today will soon be taken for granted so that even greater things will be expected. So what does the future hold? Semantic Scholar (see reference 28 above) offers a succinct future view. The speculation is that research might follow several different paths, a suggestion borne out by other material. For instance, “In the future, robots may be completely autonomous, completely dependent, or even a hybrid of these 2 types of machines.” The paper does continue to outline some of the challenges of complexity that would have to be taken into account for total autonomy to be practical, mainly the differences between patients and their specific conditions

and the robot’s current inability to ‘think on its feet’, i.e. make on-demand adjustments to manage unexpected developments. The Semantic Scholar also suggests that it should be possible for robots to operate in a guided mode during key processes in the operation and wholly autonomously during other subroutines such as “wound closing clamping and basic manipulation.” As well as big developments in what robots are available, there might well be developments in further miniaturisation of robotic tools to further improve access to operating sites within the brain and nervous system. Other developments that might support the greater use of robotics in surgery could be in the management of the body rather than in the robotic devices themselves. For instance, in ‘Future trends in Robotic Neurosurgery’29 the authors point out that, “the compactness of the head allows less soft tissue motion during the intervention, enabling a more accurate use of pre-operative planning.” But that, “once the skull is open during the procedure, there may be significant tissue motion.” So an area for future development would include compensating for brain shift and that would extend the range of possibilities for procedures such as stereotactic robotics. In conclusion, there will be many future developments in the wider field of robotics, artificial intelligence and machine learning that will be incorporated into surgical robotics.

Advanced engineering solutions for stereotactic neurosurgery Renishaw is applying precision engineering technology to the challenges of functional neurosurgery. Our aim is to help leading clinicians to enhance the safety and cost-effectiveness of their procedures, whilst improving patient outcomes through accurate delivery of implantable devices.

For more information visit www.renishaw.com/neuro

Renishaw plc Wotton-under-Edge, Gloucestershire GL12 8JR United Kingdom T +44 (0)1453 524524 F +44 (0)1453 524901 E neuro@renishaw.com

www.renishaw.com

WWW.HOSPITALREPORTS.EU| 13


IMPROVING THE SAFETY AND COST EFFECTIVENESS OF NEUROSURGERY PROCEDURES

References: 1

NHS Health Careers www.healthcareers.nhs.uk/explore-roles/doctors/roles-doctors/surgery/neurosurgery

2

Mind www.mind.org.uk/information-support/drugs-and-treatments/neurosurgery-for-mental-disorder-nmd/#.WrJPRWq5vmE

3

Royal College of Surgeons www.rcseng.ac.uk/news-and-events/media-centre/media-background-briefings-and-statistics/neurosurgery/

4

Wikipedia en.wikipedia.org/wiki/Stereotactic_surgery

5

UR Medicine www.urmc.rochester.edu/neurosurgery/for-patients/treatments/stereotactic-brain-surgery.aspx

6

JNS Journal of Neurosurgery thejns.org/doi/full/10.3171/2017.2.FOCUS1783

7

Futurism futurism.com/this-robot-completes-2-hour-brain-surgery-procedure-just-25-minutes/

8

BMA www.bma.org.uk/advice/career/studying-medicine/insiders-guide-to-medical-specialties/nhs-career-choices/surgical-specialties

9

BMJ careers.bmj.com/careers/advice/A_career_in_neurosurgery

10

Healthline www.healthline.com/health/brain-surgery#purpose

11

The Guardian www.theguardian.com/society/2016/dec/31/serious-mistakes-nhs-patient-care-rising-figures-reveal-hospitals

12

Clinical Human Factors Group www.england.nhs.uk/wp-content/uploads/2013/11/DH-2.pdf

13

NCBI Resources www.ncbi.nlm.nih.gov/pmc/articles/PMC3400482/

14

BJA British Journal of Anaesthesia academic.oup.com/bja/article-abstract/119/suppl_1/i72/4638479?redirectedFrom=fulltext

15

UK-RAS Network hamlyn.doc.ic.ac.uk/uk-ras/sites/default/files/UK_RAS_WP_SR25yr_web.pdf

16

MediSens medisens-conference.com/2018/01/22/how-sensor-technologies-will-transform-the-surgical-robots-of-the-future/

17

Semantic Scholar pdfs.semanticscholar.org/5417/b6bdb1b1a9d96211935ea1e403bb5aacb74a.pdf

18

Springer Link, Robotics in Neurosurgery link.springer.com/chapter/10.1007%2F978-1-4419-1126-1_30

19

Semantic Scholar pdfs.semanticscholar.org/5417/b6bdb1b1a9d96211935ea1e403bb5aacb74a.pdf

20

NCBI Resources www.ncbi.nlm.nih.gov/pmc/articles/PMC3400482/

21

Semantic Scholar pdfs.semanticscholar.org/a724/65991db33e329d089d22a3f74a2cc80b0798.pdf

RE Public ‘Review of Robotic Technology for Stereotactic Neurosurgery’ re.public.polimi.it/retrieve/handle/11311/944155/51698/Stereotactic%20robot%20review.pdf 22

23

Karger, ‘Stereotactic and Functional Neurosurgery’ www.karger.com/Article/FullText/449206

24

Society of British Neurological Surgeons, ‘British Neurosurgical Workforce Plan 2000-2015’ www.sbns.org.uk/index.php/download_file/view/101/83/

25

Futurism futurism.com/this-robot-completes-2-hour-brain-surgery-procedure-just-25-minutes/

RE Public ‘Review of Robotic Technology for Stereotactic Neurosurgery’ re.public.polimi.it/retrieve/handle/11311/944155/51698/Stereotactic%20robot%20review.pdf 26

27

Semantic Scholar pdfs.semanticscholar.org/adb0/90f8ef1a452503f296f2de372de7db722139.pdf

28

Semantic Scholar pdfs.semanticscholar.org/5417/b6bdb1b1a9d96211935ea1e403bb5aacb74a.pdf

29

Springer Link, ‘Future Trends in Robotic Neurosurgery’ link.springer.com/chapter/10.1007/978-3-540-69367-3_62

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www.renishaw.com


IMPROVING THE SAFETY AND COST EFFECTIVENESS OF NEUROSURGERY PROCEDURES

Notes:

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