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2 years, 10 months ago

Minimally invasive spine surgery and computer assisted navigation systems

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Neurosurgery
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CAN systems
commentary
computer assisted navigation systems
minimal access spinal surgery
MISS
spine surgery
  • Over the past 2 decades minimally invasive surgery and computer assisted navigation (CAN) systems have significantly changed spine surgery
  • Minimally invasive spine surgery (MISS) has become a significant subspeciality accounting for ~50% of all spine surgeries undertaken in the US
  • Together MISS and CAN systems promise enhanced precision, improved outcomes, and lower costs
  • CAN systems provide surgeons with improved visibility of the operating site, but emit hazardous radiation that can cause cancer
  • Spine surgery appears to be winning the challenge to increase the development of minimally invasive surgery while decreasing harmful radiation in the operating room
  • MISS is positioned to grow and increase its market share but faces some headwinds
 
- Low back pain and the global spine industry - 
 
Minimally invasive spine surgery and computer assisted navigation systems
 
Minimally invasive spine surgery (MISS) requires only a small incision and uses specialized instruments and techniques that minimize cutting and results in minimal damage of body tissue. The technique serves the increasing prevalence of degenerative spinal disorders, attributed to sedentary lifestyles of aging populations, which have helped to drive the growth of a global spinal implants and devices market. In addition to the increased availability of biologics and customizable implants and the refinement of operative techniques, the development of MISS has been supported by advances in imaging and navigation technologies that make surgical targets virtual on a monitor to improve the accuracy and precision of surgical interventions. Today, there is a growing body of research demonstrating MISS’s advantages over the traditional open approach.  However, computer assisted navigation (CAN) systems tend to emit harmful ionizing radiation that can cause cancer. Reducing radiation in the OR while improving the quality of image guidance is expected to fuel further growth of MISS.
 
 In this Commentary

This Commentary focuses on minimally invasive spine surgery and computer assisted navigation systems. Two technologies, which have changed the landscape of modern spine surgery and offer potential benefits for both patients and surgeons. Has MISS reached its market saturation? If not, what will affect the speed and extent of its further adoption? 
 
Minimally invasive and open spine surgery

Over the past 2 decades, MISS has become a significant subspeciality and currently accounts for ~50% of all spine surgeries undertaken in the US. It is positioned to increase its influence over the next decade but faces some headwinds.

As a general principle, it is preferable to intrude as little as possible when carrying out a surgical procedure to minimise damage to surrounding tissue and to speed up recovery time. Many spine procedures that once required invasive operations (open surgery) have been replaced with MISS techniques.

Open spine surgery typically involves relatively long incisions down the back to give the surgeon the best view of, and access to, the anatomy. During such procedures, it is sometimes necessary to cut through and move aside muscles and tendons to reach the affected area, which can cause damage to these tissues and prolong recovery.

In MISS the surgeon makes a small incision and then inserts a device called a tubular retractor, a stiff, tube-shaped tool that creates a tunnel to the problem area of the spine by gently pushing aside the muscle and soft tissue around the affected area. The surgeon can then put small tools through the tunnel to work on the spine and use a special microscope to view real-time X-ray images of the spine. This approach results in less damage to the muscles and soft tissues that surround the spine, which leads to a more expedited recovery.

MISS has gained popularity both with patients and clinicians and has become increasingly feasible for the management of a range of spinal disorders. Progress has been made in the development of a direct lateral approach [from the side] as well as improvements of tubular retractors. Common spine surgery treatments available through minimally invasive methods include degenerative disc disorders, herniated discs, lumbar spinal stenosis, spinal deformities such as scoliosis, spinal infections, spinal instability including spondylolisthesis, vertebral compression fractures, and spinal tumours. In 2020, MISS procedures accounted for ~50% of all spine surgeries performed in the US, which had increased from ~16% in 2012.

According to David Bell, a consultant neurosurgeon at King’s College Hospital, London, who specialises in complex spine surgery, MISS significantly improves the patient experience by, “reducing the size of the incision and the amount of tissue manipulation . . .  It also minimises post-operative discomfort, cuts infection rates, lessens blood loss and reduces a patient’s recuperation time”. See video below.
 
 
The evidence

There is a growing body of research to support the benefits of MISS, which include: (i) reduced trauma to muscles and soft tissue, (ii) better cosmetic results from smaller incisions, (iii) less blood loss, (iv) reduced risk of infection, (v) faster recovery time and less rehabilitation, (vi) diminished reliance on pain medications, and (vii) reduced hospital stays. A further perceived benefit is the increasing range of MISS undertaken in outpatient settings. Such benefits are likely to fuel the refinement of surgical techniques based on patient outcomes, and lead to the growth of MISS.
 
However, not all studies are so positive about the benefits of MISS. A 2017 review of 17 randomized controlled trials, which compared MISS against open procedures for three common disorders, concluded that, “the evidence do not support MISS over open surgery for cervical or lumbar disc herniation”. The study suggests that there were some advantages for transforaminal lumbar interbody fusion (TLIF), [a procedure that melds the front and back sections of the spine through a posterior approach], but “at the cost of higher revision rates, higher readmission rates and more than twice the amount of intraoperative fluoroscopy”. [an imaging technique employed to improve intraoperative visualization of the operating field, which emits hazardous radiation]. The study concludes that, “Regardless of patient indication, MISS exposes the surgeon to significantly more radiation”. 

Two papers published in the January 2020 edition of the Journal of Spine Surgery report on a global survey of 430 surgeons to assess the extent of MISS and the training surgeons receive. The response rate was significant at 67%. 33% of respondents were neurosurgeons, 55% orthopaedic surgeons and 12% were surgeons with other postgraduate training. One research paper concludes that, “endoscopic spinal surgery is now the most commonly performed MISS technique”, and the other suggests that, “very few MISS surgeons are fellowship trained but attend workshops and various meetings suggesting that many of them are self-thought. Orthopaedic surgeons were more likely to implement endoscopic spinal surgery into the routine clinical practice”.
A review of the state of MISS reported in the June 2019 edition of the Journal of Spine Surgery confirms MISS as a significant subspeciality, “evidenced by the large and constantly growing body of literature on this topic”, and driven by “significant advancements in imaging and navigation technologies, refinement of operative techniques, availability of biologics and customizable implants, and most importantly, evidence of feasibility, efficacy, safety and value, compared to traditional approaches as demonstrated by the current literature”.
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If spine surgery fails to relieve low back pain why is it increasing?


 
Unmistakably, over the past two decades, MISS has become increasingly feasible, efficient, and popular. An important question is, how fast is MISS advancing? There is a paucity of research, which addresses this question. However, a global survey of spine surgeons published in the January 2020 edition of the Journal of Spine Surgery provides some insights. Findings suggest there are regional variations in the acceptance and utilization of MISS. The study surveyed 586 spine surgeons in 5 major regions of the world, which yielded 292 usuable responses: a significant response rate of ~50%. 70% of spine surgeons in Asia and South America thought MISS was accepted into mainstream spinal surgery in their practice areas compared to 63% of spine surgeons in North America, 53% in Europe and 50% in Africa & the Middle East. The percentage of spine surgeons that reported using MISS was higher: Asia (97%), Europe and South America (89%), and Africa & the Middle East (88%). Surgeons in North America reported the lowest rate of MISS implementation globally.  
 
Although innovations and techniques in MISS have continued to develop over the past decade, a significant percentage (~50% in the US) of surgeons are understood to use open surgical techniques. Reasons for this include: (i) lack of adequate surgeon training and experience, (ii) the steep learning curve needed for MISS, (iii) inadequate hospital resources and (iv) the patchiness of research on the benefits of MISS. It seems reasonable to suggest that such factors affect the adoption rate of MISS. But perhaps the most significant factor influencing the speed of its adoption will be the rate of development of robotic surgical systems. An understanding of the impact of these factors will help producers hone their strategies and business models.
 
Computer assisted navigation systems

A common therapy to correct spinal disorders is fusion, which melds together two or more vertebrae so that they heal into a single, solid bone. Spinal fusion surgeries use implants of biocompatible materials, such as titanium, as well as rods, plates, screws, and interbody cages and account for the largest segment of the global spine market.
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Low back pain, spine surgery and market shifts
During spinal fusion procedures, pedicle screws are used for spinal fixation, stability, and fusion. The incorporation of such screws into spine surgery in the early 1960s was a significant advance because it offered stability and decreased rates of pseudarthrosis [failure of a fractured bone to heal] compared to previous methods. However, subsequent studies suggested that there was a percentage of pedicle screws inaccurately placed, which could harm adjacent structures and potentially have mechanical, neurological, and vascular consequences for patients.
Image guidance systems were a noteworthy development in spine surgery to reduce the morbidity associated with the mispositioning of pedicle screws and today such systems are used widely. Fluoroscopy, an early guidance method, provided real-time X-ray imaging for guiding interventional procedures, which resulted in more accurate placement of screws, but such systems emitted hazardous ionizing radiation that surgeons, patients, and OR staff were subjected to. Any spine surgery that is visualized with fluoroscopy can involve 10 to 12X higher amounts of radiation from the use of X-rays compared to non-surgical procedures. Compared to a hip surgeon, a spine surgeon can experience 50X more harmful emissions over the course of a professional career and this has been linked to the development of cancers. Reducing radiation exposure is an important challenge.
 
Guided systems and reduced radiation

Newer intraoperative navigation modalities have been found to reduce radiation exposure significantly compared to traditional fluoroscopic guided percutaneous surgical techniques, and have become an important addition in spine surgery. Real-time image guidance, along with continuous computation and scan integration by the navigation system, allows a surgeon to visualize a comprehensive 3D picture of the operating site. Intraoperative computerized tomography (CT) scans [the use of X-rays and a computer to create detailed images of the operating site], together with infrared and other optical guidance technologies have substantially increased the accuracy and precision of spine surgeons to place pedicle screws. 
 
One such enhanced guidance system is ultralow radiation imaging (ULRI) coupled with image enhancement and instrument tracking (IE/IT). This is a new image modifier that allows a computer to show real-time movement of an instrument as it is adjusted, mimicking live fluoroscopy, but without continuous radiation production. Recent research suggests that ULRI-IE/IT systems, “can dramatically reduce radiation output and the number of images acquired and time needed to perform fluoroscopic procedures”. 
 
There are numerous FDA approved advanced CAN systems but let us briefly describe some popular ones. The Airo Mobile Intraoperative CT-based Spinal Navigation system was approved by the FDA in 2013, and developed by Brainlab, a privately held German MedTech company headquartered in Munich. The technology is one of the pioneers of advanced surgical navigation platforms and has many similarities to other CAN systems. It uses a mobile circular scanner attached to the operating table for 360° imaging, and a scanning stereotactic camera, which uses a set of three coordinates for instrument registration. Research published in the July 2018 edition of the Journal of Neurosurgery suggests that the Airo “mobile CT scanner reduced the rate of screw repositioning, which enhanced patient safety and diminished radiation exposure for patients, but it did not improve overall accuracy compared to that of a mobile 3D platform”.
 
Another popular system is Medtronic’s Stealth Station Spine Surgery Imaging and Surgical Navigation with O-arm, a portable imaging device that fits over the surgical table to take images of the operating field. This uses similar technology to Brainlab’s Airo, but opens at 90° to allow for mobilization around the patient. A third system is produced by Ziehm Imaging, another German company, which specializes in the development and manufacture of mobile C-arms [imaging devices that can be used flexibly in operating rooms]. In 2015, the company received FDA approval for the Ziehm Vision FD Vario 3D with NaviPort Integration. This is an intuitive technology, which obtains images via a 190° rotation with a C-arm around the patient and provides surgeons with, “crystal-clear and distortion-free 3D images for maximum intraoperative visualization of anatomical structures”. However, if its reference clamps are moved after the initial registration process, repeat CT scanning is required to re-register the clamps. Stryker’s SpineMask Tracker and SpineMap Software system overcome this problem by gluing its reference trackers to patients.
 
With the widespread use of CAN systems in spine surgery there is an increasing number of studies, which demonstrate the advantages of such technologies. For example, two large meta-analyses suggest that CAN systems significantly increase the accuracy of pedicle screw placement compared to freehand placement. Research also suggests that patients who undergo CAN pedicle screw placement have lower complication rates than those who undergo freehand placement.
 
Notwithstanding, findings of a global survey conducted in 2013 and reported in the September 2019 edition of The Spine Journal suggest that ~78% of surgeons still use two-dimensional fluoroscopy during spine surgery. Despite the improved accuracy and reduced radiation provided by advanced computer-assisted spine navigation systems. This could be associated with costs, prolonged operative times, and their cumbersome nature.
 
Machine-vision image guided surgery system

7D Surgical, a Toronto based company that develops advanced optical technologies, has sought to overcome challenges inherent in traditional CAN systems by developing a machine-vision image guided surgery platform, [FLASH™]. The technology employs a satellite-based global positioning system (GPS), to create a 3D image of a patient’s anatomy, and uses visible light coupled with machine-vision algorithms that eliminate exposure to intraoperative radiation. Other benefits of 7D’s system include its rapid set up time and its minimal workflow disturbance. The fact that its navigation camera is integrated into the surgical light, eliminates the need to stop surgery and position supplemental surgical equipment, thereby allowing for continuous access to the surgical field. Further, and unique to FLASH™, is the fact that its reference clamp can be repositioned, and images re-registered within ~20 seconds. This facilitates seamless clinical applicability and reverses many of the drawbacks of preceding navigation systems. In May 2021, SeaSpine, a Nasdaq traded spine company, announced the acquisition of 7D in a deal valued at US$110m. In July 2021 SeaSpine received FDA approval of 7D’s advanced guidance system for MISS.
 
Takeaways

Over the past two decades, MISS has had a significant impact and established itself as a subspeciality throughout the world. Although it is difficult to calculate, it appears that ~50% of spine surgeries could still be open procedures. This suggests that strategic questions facing producers include whether MISS will expand further, and if so, at what speed. This Commentary suggests some factors, which are likely to impede the adoption rate of MISS. However, perhaps the most significant challenge to MISS is not the prevalence of open surgery, but the rapid rise and adoption of robotic surgical systems. Research published in the January 2020 edition of the Journal of the American Medical Association on the trends in the adoption of robotic surgery concludes, “Hospitals that launched robotic surgery programs had a broad and immediate increase in the use of robotic surgery, which was associated with a decrease in traditional laparoscopic minimally invasive surgery”. Robotic surgical systems in spine surgery is the subject of a forthcoming Commentary.
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2 years, 10 months ago

If spine surgery fails to relieve low back pain why is it increasing?

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Neurosurgery
Tags:
commentary
complex spine surgery
LBP
low back pain
lumbar spinal fusion
spine fusion
  • Surgery has become a common therapy for low back pain (LBP) and degenerative disc disorders, but it often fails to relieve pain
  • The incidence rates of spine surgery are high and increasing and contribute to a US$10bn global spinal implant and devices market
  • We attempt to explain a paradox: If spine surgery fails to relieve LBP why is it increasing?
 
  
If spine surgery fails to relieve low back pain why is it increasing?
 
 
Low back pain (LBP) is a common age-related condition. In 2017, its point prevalence was ~7.5% of the global population, or ~0.58bn people. The condition is associated with degenerative disc disorders and is a leading cause of most years lived with disability. Spinal fusion is a common neurosurgical or orthopaedic surgical treatment to correct degenerative spinal disorders that can present as LBP. The procedure joins small bones in your spine (vertebrae), and can be performed at any level in your spine. The basic idea is to fuse together two or more vertebrae so that they heal into a single, solid bone. Such procedures have fuelled a global spinal implant and devices industry valued at ~US$10bn, growing at a compound annual growth rate (CAGR) of ~5% and concentrated in wealthy nations; the US, the EU-27 and Japan. Spinal fusion accounts for the largest share of this market, and is projected to reach ~US$8.5bn by 2026, exhibiting a CAGR of ~3.6%.
 
LBP is challenging to diagnose, and effective treatment is elusive, but surgical therapies have become commonplace with a significant proportion failing to relieve pain. So, why is spine surgery increasing? 
 
In this Commentary
 
Surgery may be able to fix the condition of degenerative disc disorders, but not eliminate pain. After spine surgery, a percentage of patients still experience pain, called ‘failed back syndrome’, which is characterized by a continuation of pain and an inability to return to normal activities. This has led to the paradox: If spine surgery fails to relieve LBP why is it increasing? We suggest 7 factors, acting in concert, help to explain this paradox, but stress that the evidence we present is circumstantial.
 
1. Clinical guidelines for LBP
 
Clinical practice guidelines are developed by multi-disciplinary teams of health professionals using an evidence-based approach, combining the best research available with expert consensus on best practice. In the UK, the National Institute for Health and Care Excellence. (NICE) is the body responsible for producing such guidelines. In the US the Institute of Medicine (IOM) first recommended the development of guidelines in 1990. Soon afterwards, several professional healthcare organizations such as the North American Spine Association (NASS) began producing their own guidelines for specific disorders. For this Commentary we use clinical guidelines provided by NICE and NASS.

As a first line therapy for LBP, NICE recommends a treatment package of, “exercise in all its forms, - e.g., stretching, strengthening, aerobics or yoga - advice and education, and if necessary, the inclusion of manual and psychological therapies”.

According to Spine Health, in the US therapies for LBP and degenerative disc disorders, “are primarily to reduce baseline pain and prevent pain flare-ups as much as possible. Most cases of degenerative disc pain are manageable through a combination of pain management methods, exercise/physical therapy, and lifestyle modifications”.

NASS 2020 guidelines for the ‘Diagnosis and Treatment of Low Back Pain’ pose 12 critical questions on the efficacy of the use of surgical treatment versus medical/interventional treatment, and conclude that it is unable to answer the questions because of the dearth of evidence. Here inter alia is a flavour of the questions posed by NASS:
  • Q In patients with LBP, does surgical treatment versus medical/interventional treatment alone decrease the duration of the pain, decrease the intensity of the pain, increase the functional outcomes of treatment, and improve the return-to-work rate?
  • Q In patients undergoing surgery for low back pain, which fusion technique [the question lists 5 common techniques] results in the best outcomes for the following: decrease the duration of pain, increase the functional outcomes of treatment, and improve the return-to-work rate?  
  • Q In patients undergoing fusion surgery for low back pain, does the use of bone growth stimulators  (versus fusion alone), decrease the duration of pain, increase the functional outcomes of treatment, and improve the return-to-work rate?
  • Q In patients undergoing fusion surgery for low back pain, does the use of BMP [bone morphogenetic proteins] (versus fusion alone), decrease the duration of pain, increase the functional outcomes of treatment, and improve the return-to-work rate?
  • Q In patients with LBP are there predictive factors, which determine the benefit of initial treatment with surgical intervention versus initial medical/interventional treatment?
NASS answers all 12 questions with the same statement: “A systematic review of the literature yielded no studies to adequately address this question”. This emphasises the absence of clinical evidence to confidently determine efficacious surgical therapies for LBP. NASS stresses that its guidelines are not intended to be viewed as a “standard of care”, but as “recommendations to assist in delivering optimum, efficacious treatment and functional recovery from nonspecific low back pain”.
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Low back pain, spine surgery and market shifts
2. Poor prognostic indicators for spinal surgery
 
This dearth of evidence makes therapy decisions challenging for clinicians. A study published in the 2018 edition of the Asian Spine Journal suggests that a proportion of the large and increasing spine fusion surgeries performed to reduce LBP and degenerative disc disorders fails because of weak prognostic indicators. Researchers stress that, “spine surgeons need to be well aware of the many poor prognostic indicators for spinal surgery”. The lack of high-quality evidence to support the use of spinal fusion for LPB fosters disagreement among physicians as to when spinal fusion should be performed. 
 
 In the video below Nick Thomas, a consultant neurosurgeon at King’s College Hospital, London, describes some of the challenges of poor prognostic indicators for LBP: “Dilemmas of managing low back pain arise because we (clinicians) have precious few pre-operative investigations that give us a clear idea as to whether a spinal fusion may or may not work. When an MRI is taken it can be very difficult to determine whether the degenerative discs one sees on the scan are normal age-related changes or whether they truly reflect a problem that might be generating the back pain”, says Thomas.
 
 
Such dilemmas in the management of LBP are not made easier by the fact that there are few studies, which compare spinal fusion to a placebo procedure. Most spine surgery research compares one fusion technique to another or to a form of non-surgical treatment. According to a study published in the March 2020 edition of The Lancet , “Over the past 10 years there has been increasing recognition of the importance of the placebo effect, particularly how strong this effect could be for a surgical procedure that involves high-intensity medical care, strong analgesia, and often physiotherapy”. Findings of recent placebo-controlled surgical trials for common vertebroplasty procedures [a procedure for stabilizing compression fractures in the spine], in which special cement is injected into a fractured vertebra, “have been shown to be largely ineffective, but continue to be in common use”. Further, randomised clinical studies, which are regarded as providing the highest-quality evidence, suggest that spinal fusion has little advantage over a well-structured rehabilitation programme for LBP.
 
A study published in the December 2018 edition of the Journal of Internal Medicine analysed data from 33 randomized controlled trials and other studies comparing spinal fusion to nonoperative solutions for LBP and degenerative spine conditions, and concluded that, “The overwhelming evidence simply doesn’t support spinal fusion (and its high costs and risks) for back pain and degenerative spine conditions over nonoperative solutions”. A 2019 WHO Bulletin entitled ‘Care for low back pain: can health systems deliver?’ suggests that, “many healthcare systems are not designed to support physical and psychological therapies for LBP”, and stresses that, “major international clinical guidelines now recognize that many people with low back pain require little or no formal treatment”.
 
3. Uncertainties of diagnosing LBP
 
Adding to poor prognostic indicators are the difficulties of diagnosing LBP. The aetiology of LBP is rarely precisely identified. Findings also suggest that a pathoanatomical diagnosis of LBP can only be made in ~5% to 7% of patients. LBP in patients where no such diagnosis is possible is often labelled, unscientifically, “chronic LBP”.
 
A 2016 study suggests that in ~80% to 95% of patients with LBP the cause cannot be determined despite the existence of sophisticated imaging techniques and a plethora of diagnostic tests. It seems reasonable to suggest that challenges associated with diagnosing LBP could provide tacit support for clinicians to continue carrying out surgical procedures they were trained to perform.
 
4. Rapidly ageing populations
 
A rapidly increasing global geriatric population is a significant factor driving the growth of the spinal fusion market. According to the United Nations, ~16% of the world’s population will be ≥65 by 2050. In North America and Europe, ~25% of their respective populations will be aged ≥65 by 2050. Common disorders of old age include LBP and degenerative disc disorders.
 
Age is significant because most spinal fusion procedures are performed on individuals ≥60 living in wealthy nations. This age cohort is the fastest-growing demographic in the principal spine markets of the US, Western Europe, and Japan. For example, the US has ~49m people (~15% of the population) who are aged ≥65. This cohort is projected to reach ~84m by 2050. The EU-27 has ~90m people (~20% of the population) ≥65. By 2050 the EU population ≥65 is expected to reach ~130m. The population structure of the UK is similar to that generally observed in the EU-27 with ~12m people aged ≥65, ~18.5% of the population, which is projected to double by 2050. Japan has the oldest population in the world with ~36m people (~29% of the population) who are ≥65. By 2025, Japan’s ≥65 population is expected to decrease to ~33m, but the percentage of the population ≥65 is projected to increase to ~32%. It seems reasonable to suggest that these vast and rapidly increasing older population cohorts are significant drivers of the growth of age-related LBP and the consequent increasing incidence rates of spine surgeries.

Global life expectancy has continued rising and is expected to reach 77 years by 2050, up from 70 in 2015. The number of people ≥65, who account for most spine surgeries, will climb by >60% in the next 15 years: from ~0.6bn in 2015 to ~1bn by 2030. The phenomena of aging and shrinking populations, means that every year, a shrinking pool of working-age people are forced to support an expanding pool of ageing patients with LBP and degenerative disc disorders. In the medium to long term such support seems unsustainable.
 
5. Obesity
 
The prevalence of LBP in individuals ≥65 who are also obese is significantly higher than in people who are of average weight. Not only are the populations in the principal spine markets ageing, but they are also experiencing rising incidence rates of obesity. According to the World Health Organisation, obesity throughout the world has nearly tripled since 1975. Today, there are ~2bn adults overweight, of those, ~650m are obese [body mass index (BMI) ≥30 kg/m²]. In England ~28% of adults are obese and a further 36% are overweight. In the US, 43% of people ≥60 is obese. From 2000 to 2018, the prevalence of obesity in the US increased from 31% to 42%, and the prevalence of extreme obesity [BMI ≥40 kg/m²] increased from 5% to 9%. 
 
6. High costs of spine surgeries
 
Most spine surgeries in the US have been covered by health insurance operating a fee-for-service model. A future Commentary describes how this model is changing. Notwithstanding, fee-for-service has meant that healthcare providers have been able to charge significant amounts for their services and oblige insurance companies to reimburse them, while inflicting minimal costs on patients. Although there is a paucity of studies which analyse recent trends in spinal fusion volume, utilization, and reimbursements, Medicare [a US national health insurance programme] payment trends have seen a decreasing allocation of reimbursements for surgeons generally. Research published in the October 2020 edition of The Spine Journal suggests that this, “may be the effect of value-based cost reduction measures, especially for high-cost orthopaedic and spine surgeries”.
 
Each year in the US, >$90bn is spent on low-back pain alone and ~1.6m spinal surgeries are performed. The cost of a single-level spinal fusion in a less expensive region of the US is ~US$65,000 for Medicare or ~US$100,000 with private insurance. In more expensive areas, such as New York or Los Angeles, these costs can grow by 2 to 3 times. In remote regions, such as eastern Wyoming and Alaska, high costs of surgical procedures can be a function of the scarcity of specialist clinicians. Such high costs could be an incentive for physicians to perform surgery. Research supports this by suggesting that clinicians are more likely to recommend surgery, even though it is neither the optimum nor the only treatment option available.
 
7. Benign reimbursement policies
 
Historically, in the US, third-party payors have tended to reimburse spine surgery for LBP more than non-invasive therapies. Insurers have also tended to reimburse surgical services rather than patient outcomes, although this is changing. For decades, the overwhelming percentage of patients bore little responsibility for the cost of spine surgeries. However, a 2016 New York Times article  reported that reimbursement policies for spine surgery were beginning to change, and suggested that, “financial disincentives accomplished something that scientific evidence alone didn’t”. The Times article drew on findings of research published in the June 2016 edition of the journal Spine, which argued that, “spinal fusion rates continued to soar in the US until 2012, shortly afterwards Blue Cross of North Carolina said it would no longer pay”. It seems reasonable to assume that benign reimbursement policies helped to drive the increase in spine surgeries. However, following the Blue Cross decision other insurers followed, and US payors started to move away from a fee-for-service model towards  reimbursing “value”. This shift, which is expected to continue, has slowed the growth rate of common spine surgeries.
 
Takeaways
 
Over the past three decades, the escalating prevalence of LBP, the challenges of diagnosing the condition, rapidly ageing populations, rising incidence rates of obesity, high costs of spine surgeries, and benign reimbursement policies, have all contributed to what has become a global spinal implant and devices industry. Such conditions encouraged an ecosystem in which the incidence rates of spine surgeries have soared, while LBP has persisted in a significant percentage of patients following surgery. Although the spine market is beginning to transform itself by moving away from a fee-for-service model towards a value-based model, which aims at providing patients with the best outcomes at the lowest cost, do not underestimate the time it will take for this transformation to succeed. Indeed, it seems reasonable to suggest that, given the structure and nature of the industry, the paradox that this Commentary attempts to explain will persist, at least for the near to medium term.
 
Post Scriptum
 
Findings of a 2016 study in the peer reviewed Malaysian Orthopaedic Journal conclude that, “The spine, unfortunately, has been labelled as a profit centre and there are allegations of conflicts of interest in the relationship of doctors with the multi-billion-dollar spinal devices industry. The spine industry has a significant influence not only on research publications in peer review journals, but also on decisions made by doctors, which can have a detrimental effect on the welfare of the patient”.
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2 years, 11 months ago

Low back pain, spine surgery and market shifts

HealthPad
Directory:
Neurosurgery
Tags:
commentary
complex spine surgery
LBP
lower back pain
spine devices
spine fusion
  • Low back pain (LBP) and degenerative spinal disc disorders are leading age-related causes of disability throughout the world
  • Global populations continue to age, and incidence rates of LBP and degenerative disc disorders continue to increase
  • Surgery has become a common therapy for the conditions and their incidence rates have risen sharply over the past two decades
  • This has fuelled a global US$10bn spinal implant and devices market
  • Spine surgeries tend to be paid for by working age populations
  • In wealthy spine markets working age cohorts are shrinking
  • This suggests spending levels on spine surgery will be squeezed
  • The knock-on effects of this are likely to put pressure on spine companies to adapt their strategies and business models
 
Low back pain and the global spine industry

Low back pain, spine surgery and market shifts
 
Low back pain (LBP) is a common age-related health condition associated with degenerative spinal disorders, and recognised by the World Health Organisation (WHO) as one of the top ten global disease burdens. In most wealthy nations, low birth rates and relatively high life expectancy have resulted in the number of working age people shrinking and the number of retirees with sedentary lifestyles increasing. This has led to a high prevalence of LBP and age-related spinal disorders.
 
First-line clinical guidelines for LBP recommend non-surgical treatments and encourage physicians to be cautious about surgical solutions. Diagnosing LBP is challenging, and doctors constantly contend with treatment dilemmas. However, over the past three decades spine surgery has become a significant therapy for LBP.
 
A common procedure used to treat a range of degenerative disc disorders, which present as LBP, is spinal fusion. This is a neurosurgical or orthopaedic surgical technique to permanently connect two or more vertebrae in your spine so that they heal into a single, solid bone. The procedure can be performed at any level in the spine and prevents any movement between the fused vertebrae. The technique is designed to mimic the normal healing process of broken bones.
 
In this Commentary
 
This Commentary suggests that as global populations have aged, so the incidence rates of LBP and degenerative disc disorders have increased and become a leading cause of age-related disability throughout the world. Spine surgery has become a common therapy for the conditions. This has fuelled a global spinal implant and devices market. Spine surgeries tend to be paid for by working age populations, which are shrinking in the wealthy spine markets of the world. This suggests that spending levels on spine surgeries will be squeezed and this will put pressure on spine companies to transform their strategies and business models.
 
The global burden of LBP

A series of three research papers on LBP and its associated disabilities published in the March 2018 edition of The Lancet estimate that ~0.54bn people worldwide are living with LBP, which has risen by more than 50% since 1990, and is projected to increase even more as the world's population ages and as populations in lower- and middle-income countries move to urban centres and adopt more sedentary lifestyles.
 
The importance given to treating LBP is because of the significant burden it inflicts on individuals, healthcare systems and productivity. The Global Burden of Disease Study 2017 suggests that LBP accounts for some of the highest numbers of disability-adjusted life years (DALYs) worldwide [DALY is a measure of overall disease burden, expressed as the number of years lost due to ill-health, disability or early death].
 
According to the UK’s 2014 NHS National Pathfinder Study, LBP is responsible for the loss of 2,313 DALYs per 100,000. This is a substantially higher ratio than the remainder of musculoskeletal conditions (911), depression (704) and diabetes (337) combined, and accounts for 11% of the overall disability burden from all diseases in the UK, where the burden of LBP is on the increase both in absolute (~3.7%) and proportionate (~7 to 8.5%) terms. The increased prevalence of LBP creates added demand and escalating costs for NHS England, estimated to be >£12.3bn (US$17bn) per year.
A 2012 study published in The Spine Journal suggests that LBP accounts for >3% of all visits to A&E in the US and estimates that each year, “>2m episodes of LBP occur among an at risk population of over 1.48bn person-years for an incidence rate of 1.39 per 1,000 person-years”. Findings of a 2016 study suggest that, “US adults with LBP are socioeconomically disadvantaged, make frequent healthcare visits and are often covered by government-sponsored health insurance”. The US Bureau of the Census estimates that, each year, LBP costs Americans ~US$50bn in healthcare costs. If you add in lost wages and decreased productivity, this figure easily rises to >US$100bn.

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Age of the aged and low back pain
LBP and degenerative spinal disorders

In the video below Ranj Bhangoo, a consultant neurosurgeon at King’s College Hospital, London explains how LBP and degenerative disc disorders are overwhelmingly the result of normal wear and tear, which occur over time as you grow older. Years of constant use and absorbing daily shocks take their toll, which suggests that, sometime during your lifetime, you will suffer from LBP. In most cases, it is not your spinal vertebrae that experience the effects of the wear and tear, but the 23 cartilage-based structures (discs), which sit between your vertebrae. These are filled with a jelly-like substance and act as shock absorbers, help to hold your vertebrae together and facilitate slight mobility in your spine. As you age, your discs lose their jelly-like substance, start to crack, and begin to naturally degenerate. This is believed to manifest itself as LBP, which can radiate down your leg and cause a condition called sciatica.
 
 
Spine surgery
 
If you are over 50, suffer from LBP, live in the US, Europe, or Japan, and have medical insurance, it is likely that during your lifetime you will have surgery to reduce your pain following a period of a non-surgical therapy. Scientific evidence supports surgery in a select group of patients who have failed to respond to non-operative treatments over a minimum of six months. However, a significant percentage of spine operations fail to relieve back pain and between 10% and 46% of primary spine procedures require revision surgeries.
 
In the video below, Ranj Bhangoo describes the care taken by clinicians not to rush into surgery for LBP.  When a patient presents with back pain, it is important to ask three questions: “Is the history of the pain compatible with a particular disc causing that pain? Does an examination suggest that a particular disc is causing the problem? Does a scan show that the disc you thought was the problem is the problem? If the answers ‘fit”, then there might be benefit in considering some treatment options, but not necessarily surgery. . . . . . Because 90% of us will get back pain at some point in our lives, 90% of us don’t need an operation”, says Bhangoo, whose opinion resonates with that of the Mayo Clinic: “Back surgery can help relieve some causes of back pain, but it’s rarely necessary,” and although “back pain is extremely common, surgery often fails to relieve it”.

 
 
 
Clinical dilemmas

Although first line clinical guidelines recommend non-surgical treatments for LBP and degenerative disc disorders and clinicians are cautious about possible treatment options, over the past three decades surgery has become a relatively common therapy for LBP and has fuelled a global spinal implant and devices market. The Lancet’s 2018 studies on LBP suggest that, “gaps between evidence and practice exist, with limited use of recommended first-line (non-surgical) treatments and inappropriately high use of surgery”.
 
However, the nature of evidence underpinning the use of non-surgical treatments for LBP does not help clinicians in their choice of therapies. A research paper, published in the March 2020 edition of the BMC Medical Journal, critically appraises the current evidence for non-surgical therapies for LBP and concludes that while, “pain management services may be cost effective for the management of low back pain the quality of evidence is variable”.
  
Spinal fusion

Spinal fusion is a common surgical therapy for a number of spinal disorders, some of which may present as LBP and include: (i) degenerative disc disease, which occurs when one or more of your discs between your vertebrae deteriorate and cause pain, (ii) spondylolisthesis, which occurs when one of your lower vertebrae slips forward onto the bone directly beneath it, (iii) spinal stenosis, a narrowing of the spaces within your spine, most often in your lower back and neck, which can put pressure on the nerves that travel through your spine, (iv) kyphosis, a spinal disorder in which an excessive outward curve of your spine results in an abnormal rounding of your upper back, and (v) scoliosis, which is a sideways curvature of your spine.
 
Despite being a common procedure, spinal fusion is a major surgery, which can be associated with significant morbidity and occasionally with mortality. In the video below Nick Thomas, a consultant neurosurgeon at King’s College Hospital, London, describes spinal fusion, which in certain circumstances, may be beneficial in improving pain.
 
 
Incidence rates of spinal fusion increasing

According to findings published in the March 2019 edition of the journal Spine, >2m spinal fusions were performed in the US in 2015. This represented an increase of 32% since 2004, with the largest increase (73%) among patients ≥65. Outcomes of spinal fusion procedures vary depending on the condition for which the surgery is performed. When performed for spinal deformities and spondylolisthesis, reported outcomes are generally favourable. However, the success rate of spinal fusion as a therapy for LBP and degenerative disc disorders is patchy.
 
Evolving techniques

Given these uncertainties, emphasis has been given to several evolving techniques such as interbody fusion and lumbar disc arthroplasty, which are more complex, technically demanding, and higher risk types of fusion. The former procedure involves removing your intervertebral disc and joining two or more vertebrae together using screws and interbody spine cages. These are hollow threaded cylindrical implants commonly constructed of polyetheretherketone (PEEK) and titanium, which have desirable biocompatibility and mechanical properties. Cages are filled with bone graft, and eventually become part of your spine.


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Can 3D printing and the use of new alloys reduce the high costs of producing and marketing spinal implants?
 
The latter procedure replaces a damaged spinal disc with an artificial one designed to support your vertebrae while preserving motion. These, and other hybrid techniques, are still relatively novel procedures despite promising near-term outcomes. Long-term studies demonstrating their superiority over traditional spinal fusion are required before they may be recommended to replace traditional fusion as the gold standard.

Further, recent scientific advances have allowed clinicians to explore innovative stem cell therapies in spinal fusion procedures in attempts to reduce morbidity and compensate for the limitations of autografts. However, results of research have not yet been translated into common practices to treat patients.
The incidence rates of spine surgery in the US

The US has the highest rate of spine surgeries in the world. In the 1980s rates increased by 55%. In the 1990s studies of spine surgery rates became more challenging because >20% of common spine procedures shifted to out-patient settings. Extrapolations from ambulatory surgical data suggest that throughout the 1990s, spine surgery rates continued to rise. The most rapid increase was for spinal fusion, which tripled during the decade and accounted for an increasing proportion of all spine procedures.
 
Since the 1990s, numerous studies have described the continued growth of spine surgery in the US, where today ~1.6m spine procedures are performed annually. Between 2004 and 2015, the volume of spinal fusions increased by 62%. During this 12-year period, aggregate hospital costs increased 177%, exceeding US$10bn in 2015 and averaging >US$50,000 per admission. A 1994 international comparative study found that, “the rate of back surgery in the US was at least 40% higher than in any other country and was more than five times that in England. Back surgery rates increased almost linearly with the per capita supply of orthopaedic and neurosurgeons in the country”.
 
The spinal implant and devices market

Over the past four decades, the high and increasing prevalence of spine surgeries has contributed to a high margin, profitable, global spinal implant and devices industry, comprised of ~400 companies but dominated by just four large American corporations: Medtronic, DePuy Synthes (Johnson & Johnson), NuVasive  and Stryker. These four control ~70% of the market, which in 2019 was valued at ~US$10.3bn, projected to grow at a compound annual growth rate (CAGR) of ~5%, and reach ~US$14bn by 2025. The US market segment alone was valued in 2020 at ~US$7.5bn, growing at a CAGR of 5.3% and expected to reach ~US10bn by 2025.
 
These spine market numbers include revenue from implants, instruments, and surgical assistance systems (robotics and navigation) to treat a variety of conditions. The industry has benefitted from advances in spine surgery technologies, the launch of novel bone grafting products and the increasing adoption of minimally invasive spine surgery (MISS). However, spinal fusion devices are the second largest segment of spine products behind plates and screws.
 
As a possible consequence of the industry’s rapid growth and relatively high margins, many spine companies have come to rely on linear supply chains and developed “cosy labour-intensive relationships” between producers, clinicians, hospitals, and payors. However, the high cost of spine surgery, tightening regulations and more stringent reimbursement policies threaten this business model.
 
Good news for spine companies

We know that age-related LBP and degenerative spinal disorders are significantly correlated to the incidence rates of spine surgery. The good news for the spine market is that, “virtually every country in the world is experiencing growth in the number and proportion of older persons in their populations”, and global life expectancy is rising and is expected to reach 77 years by 2050, up from 70 in 2015. The number of people ≥65, who account for most incidence of spine surgeries, is expected to increase by >60% in the next decade, from just >0.6bn in 2015 to ~1bn by 2030. A study published in the March 2020 edition of the Journal of the American Medical Association (JAMA) suggests that between 1996 and 2016, Americans spent ~US$134bn on therapies for back pain, which is more than that spent on the combined treatments for diabetes and heart disease.
 
Bad news for spine companies
 
Working age populations in the US and other spine markets ‘pay’ for the surgeries of the large and growing cohorts of retirees with sedentary lifestyles and LBP. However, working aged populations in these regions are declining because of falling fertility rates and professional women delaying motherhood. This suggests, ceteris paribus, that for the foreseeable future, a shrinking pool of working-age people will be forced to support expensive spine surgeries for a vast and rapidly expanding cohort of aging retirees.  Thus, it seems reasonable to suggest that the current trajectory of spending on spine surgeries in the major spine markets of the world is unsustainable, and increasingly, likely to exert downward fiscal pressure on spine companies.
 
Changing ecosystem

Such demographic trends are already exerting pressure on the spine market to deliver enhanced clinical outcomes at lower costs. For example, US reimbursement policies have moved away from a fee-for-service model towards a value-based model, which aims to utilize resources more efficiently by shifting the costs of over-treatment, revision surgeries and adverse clinical outcomes from payors to providers. Similar shifts are taking place in Europe and Japan. For example, in Europe fiscal pressure on healthcare systems has meant rationing and/or delaying elective spine surgeries. In Japan, more spine surgery costs are being shifted to employers and patients.
 
Population effectiveness

In wealthy spine markets decisions that used to be the sole preserve of doctors are increasingly being made by regulators, hospital administrators and other non-clinicians. This broader set of influencers have different objectives to doctors and prioritize cost effectiveness or even just costs. This is fuelling a shift away from individual patient outcomes towards a focus on the cost effectiveness of specific spine procedures on a given population. For example, the overall improvement within a cohort of patients ≥65 with LBP and degenerative disc disorders and a given level of spending by a hospital group on spinal fusions.
 
Innovations increasing in significance
 
Such shifts have encouraged innovations, which enhance outcomes and are positioned to change the standard of spine care. These include, minimally invasive spine surgery (MISS), robotics, computer assisted navigation, motion preserving technologies, and ortho-biologics, which will be discussed in future Commentaries. For now, let us finish by suggesting that such innovations could erode the competitiveness of traditional spine companies that are slow to change, and enhance the competitiveness of companies with the mindset, resources, and capabilities to invest in these evolving technologies.
 
Takeaways

Fiscal, technological, and demographic trends are driving the demand for competitively priced spinal implants and devices. Cost conscious US hospitals have consolidated to increase their buying power. Purchasing has become more centralized as hospital groups have leveraged their scale by standardizing processes and procedures across facilities. Providers have sharpened their focus on the cost effectiveness of spinal implants and devices and engaged in M&A activities to enhance their scale, R&D, and marketing. This has expanded the range of product offerings a single company supplies, but also it has increased market concentration, which advantages a few large dominant companies. The effect of these trends has yet to transform the strategies and business models of the overwhelming majority of traditional medium to small size spine companies, which will be needed for them to remain relevant in the future.
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3 years ago

Degenerative disc disease is not a disease

Ranjeev Bhangoo
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3 years ago

Surgery for degenerative disc disease

Ranjeev Bhangoo
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Sanjay Sharma

INTERVENTIONAL PAIN PHYSICIAN
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We are a team of specialist medical professionals. interventional pain physicians and Neurosurgeon,whose purpose is to relieve painful conditions of spine & joints. by using advance innovative approach with proven technology.Patients failed to respond to routine medical treatment. Our medical experts from india ,USA,europe,indonesia,middle east.put forth a joint opinion on selected cases by using advance medical knowledge & technically expertise.
JPRC is backed up by DR SANJAY SHARMA MBBS,DA,FIPM & Dr Tramboo MD FIPP (USA). Dr Lalit Bhardwaj Neuro trambo is examiner for FIPP exams and director of relives pain clinic. Dr. tramboo is also board of director for TRUMINIM. Dr tramboo is inventer of novel technique for percutaneous laminoplasty.


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4 years ago

How can you reduce the risk of having a stroke EDITED

Christos Tolias
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Dr. Sarang Rote

Best Neurosurgeon in Pune
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Dr. Sarang Rote is a Consultant Neurosurgeon & Neurointerventionist in Pune. He had very well focused training from specialty-specific Legends in Neurosurgery as well as with new generation Neurosurgeons around the world. He is trained in Neurointervention to form the pioneers of Neurointervention and many others. Also, he is well trained in the use of all-new advanced minimal invasive modalities, and technology. His area of interest are-

Cerebrovascular diseases for which he offers microscopic cerebrovascular neurosurgery as well as endovascular neurosurgery i.e. Neurointervention.
Skull base tumors & other lesions for which he offers microscopic as well as endoscopic skull base neurosurgery.
Stroke intervention & surgery.


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4 years, 6 months ago

Standard, silver or antibiotic?

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  • Hydrocephalus is a chronic condition that occurs when excess cerebrospinal fluid (CSF) collects in your brain’s ventricles and increases pressure inside your head
  • Failure to treat the condition can lead to morbidity and death
  • First line therapy is the surgical insertion of a ventriculoperitoneal shunt (VPS) to restore your CSF circulation
  • A significant risk with the procedure is infection
  • To reduce infection manufacturers’ impregnate standard shunts with either silver or antibiotics and market the impregnated shunts at higher prices
  • Which VPS (standard, silver or antibiotic) provides patients with the most protection from infection?
  • Which VPS is most cost effective for healthcare systems?

 

Standard, silver or antibiotic?

 

“It” affects people in all walks of life and from every socioeconomic background throughout the world. “It” is as common as Down's Syndrome and more common than Spina Bifida. One out of every 1,000 babies are born with “it”. “It” affects about 1m people in the US  and “it” is the most common reason for brain surgery in children.
 
“It” is Hydrocephalus; a chronic condition that occurs when excess cerebrospinal fluid (CSF) collects in your brain’s ventricles, (fluid-filled areas). CSF disperses from your ventricles around your brain and spinal cord. Too much CSF may result in an accumulation of fluid, which can cause the pressure inside of your head to increase. In a child, this causes the bones of an immature skull to expand and separate to a larger-than-normal appearance.

There are no medical therapies to effectively treat hydrocephalus. The only viable treatment is surgical. The gold standard therapy is the insertion of a ventriculoperitoneal shunt (VPS), which is a common surgical procedure to restore your CSF circulation, regulate its flow and allow you to have a normal daily life. Notwithstanding, a significant challenge is infection at the site of the surgical wound, the shunt or in the cerebrospinal fluid itself (meningitis). This effects about 15% of hydrocephalus patients and may result in further surgeries, extended hospital stays, a reduction in your quality of life and a significant hike in healthcare costs.

To reduce potential infection manufacturers’ impregnate standard shunts with either silver (silver has benefits in reducing or preventing infection) or antibiotics and market the impregnated shunts at higher prices.
 
In this Commentary

 

This Commentary describes hydrocephalus and reports findings of a clinical study designed to determine, which ventriculoperitoneal shunt (standard, silver or antibiotic) provides patients with the most protection against infection and which type of shunt is most cost effective for healthcare systems. For completeness the Commentary briefly describes the causes of hydrocephalus, its signs and symptoms and how the condition is diagnosed.  Also, the Commentary briefly describes the procedure to insert a ventriculoperitoneal shunt.

 

Hydrocephalus
 
Hydrocephalus is a condition that occurs when excess CSF collects in your brain’s ventricles. CSF cushions your brain and protects it from injury inside your skull. Also, the fluid acts as a delivery system for nutrients that your brain needs and takes away waste products. Normally, CSF flows through these ventricles to the base of the brain. The fluid then bathes your brain and spinal cord before it is reabsorbed into your blood. When this normal flow is disrupted, the build-up of fluid can create harmful pressure on your brain’s tissues, which can damage your brain.
 
There are two principal classifications for hydrocephalus: (i) communicating and (ii) non-communicating hydrocephali. Both can be subdivided into congenital (present at birth) and acquired (occurs following birth). Communicating hydrocephalus can also be subdivided into normal pressure hydrocephalus (NPH) and hydrocephalus ex-vacuo, which occurs when there is damage to your brain caused by stroke or injury. It is generally understood that congenital hydrocephalus can be caused by genetic defects, which can be passed from one or both parents to a child, but the direct hereditary links are still being investigated. Notwithstanding, experts have found a connection between a rare genetic disorder called L1 syndrome and hydrocephalus. L1 syndrome is a group of conditions that mainly affects the nervous system and occurs almost exclusively in males.
 
Most babies born with hydrocephalus or who develop hydrocephalus as infants will have a normal lifespan, and approximately 40 to 50% will have normal intelligence. Seizure disorders have been diagnosed in about 10% of children with hydrocephalus and the mortality rate for infants is approximately 5%.
 
In the video below Sanj Bassi, a Consultant Neurosurgeon at King’s College Hospital, London and a member of the London Neurosurgery Partnership, describes hydrocephalus:

 

Causes
 
Some premature babies have bleeding in the brain, which can block the flow of CSF and cause hydrocephalus. Other possible causes of the condition include: X-linked hydrocephalus, which is caused by a mutation of the X chromosome and rare genetic disorders such as Dandy Walker malformation. This  is  a congenital (present at birth) defect, which affects the back part of the brain (the cerebellum) that controls movement, behaviour and cognitive ability. The most common cause of congenital hydrocephalus is an obstruction called aqueductal stenosis, which occurs when the long, narrow passageway between your third and fourth ventricles (the aqueduct of Sylvius) is narrowed or blocked, perhaps because of infection, haemorrhage, or a tumour. Other conditions, such as neural tube defects (like spina bifida), are also associated with hydrocephalus.

Signs and symptoms
 
Early signs of hydrocephalus in infants include bulging fontanel, which is the soft membranous gaps between the cranial bones on the surface of the infant skull; a rapid increase in head circumference; eyes that are fixed downward and poor feeding. In both infants and adults, symptoms include seizures; fuzzy vision, nausea, vomiting and excessive sleepiness. 

Diagnosing hydrocephalus
 
The diagnosis of hydrocephalus may be made before birth by an antenatal ultrasound. However, in many cases, hydrocephalus does not develop until the third trimester of a pregnancy and, therefore, may not be detected on an antenatal ultrasound. Congenital hydrocephalus may be diagnosed at birth. Important considerations include antenatal and birth history of your baby and whether there is a family history of hydrocephalus. Physical examination at birth can also detect hydrocephalus. A measurement of the circumference of your baby’s head is taken and compared to a graph that can identify normal and abnormal ranges for a baby’s age. Of interest to an early diagnosis for hydrocephalus are the developmental milestones in older babies since the condition may be associated with developmental delay, which might require further medical investigations for potential underlying problems. Other tests that may be performed to confirm a diagnosis of hydrocephalus include magnetic resonance imaging (MRI) and a computed tomography (CT) scan. MRI or CT images can reveal swellings of your brain or another condition that might be causing your symptoms, such as a tumour.
 
 In the video below Bassi describes how hydrocephalus is diagnosed:
 
 

 
 
Insertion of a ventriculoperitoneal shunt 
 
Although currently there is no known way to prevent or cure hydrocephalus, with early detection and appropriate intervention, the future for many patients with the condition is promising. The  gold standard treatment option available today is the surgical insertion of a ventriculoperitoneal shunt.

A shunt consists of two thin, long flexible hollow tubes, called catheters, with a valve that keeps fluid from your brain flowing in the right direction and at the proper rate and thereby reduces brain pressure to a safe level. To install a shunt a surgeon will make a small insertion behind your ear and also drill a small borehole in your scull. One catheter is then threaded into one of your brain’s ventricles through the hole in your scull, and the other is inserted behind your ear and threaded subcutaneously down to your chest and into your abdomen where excess CSF can drain safely, and your body can reabsorb it. Your surgeon may attach a tiny pump to both catheters and place it under the skin behind your ear. The pump will automatically activate to remove fluid when the pressure in your skull increases. Shunts can be programmable (externally adjustable by a magnetic device) to activate when the fluid increases to a certain volume, or non-programmable. Most surgeons tend to choose a programmable model, despite the fact that in clinical studies both types perform comparably.
 
In the video below Sanj Bassi describes both VPS therapy and some temporary treatment options for hydrocephalus. The latter includes medicines, which decrease the production of CFS, draining fluid from the spine via a lumbar puncture and draining fluid directly from your head into a bag via an external drainage system.

 
 
 
The Lancet study
 

To determine the relative clinical benefits and cost-effectiveness of the three different ventriculoperitoneal shunts (standard, silver or antibiotic) following their de novo insertions, the UK’s National Institute for Health Research funded a large prospective multi-centre randomised controlled clinical study - The British Antibiotic and Silver Impregnated Catheters for Ventriculoperitoneal Shunts Study - (BASICS). Findings were published in the September 2019 edition of The Lancet. These concluded that shunts impregnated with antibiotics significantly reduce the risk of infection and also healthcare costs compared to both standard shunts and those impregnated with silver. Conor Mallucci, Consultant Paediatric Neurosurgeon at Alder Hey Children’s Hospital, Liverpool, UK, and lead author of the study, suggests that shunts impregnated with antibiotics should be, “the first choice for patients with hydrocephalus undergoing insertion of their first ventriculoperitoneal shunt”.

 

The Study’s clinical findings
 
Patient recruitment for the study took place between 2013 and 2017. Principal investigators assessed 3,505 patients and recruited 1,605 (children and adults) from 19 specialist neurosurgical centres across the UK & Ireland. Participants presented with hydrocephalus of any aetiology [including idiopathic intracranial hypertension (IIH), which is a condition with an unknown cause or causes and associated with raised fluid pressure around the brain]. All required an insertion of their first ventriculoperitoneal shunt.
 
All shunts used in the study were CE marked medical devices intended for the condition. Participants were randomly assigned to three groups: one group of 536 received a standard shunt, another of 531 received a silver impregnated shunt, and a third group of 538 received an antibiotic impregnated shunt. The minimum patient follow-up period was six months and the maximum two years. Six per cent of evaluable patients in both the standard and silver groups presented with infections and required a shunt revision. This compared to only 2% in the antibiotic impregnated shunt group that became infected and needed revising. The difference is significant.
 
The Study’s economic findings
 
The study’s clinical significance is enhanced by the fact that it provides the first health economic analysis of different VPS therapies from a UK perspective. Findings suggest that using an antibiotic impregnated VPS rather than either a standard shunt or those impregnated with silver, would result in annual savings to NHS England of approximately £135,753 (US$166,795) per infection avoided, which amounts to annual savings of some £7m (US$8.6m).
 
The research has a further significance because, despite the high medical costs of treating hydrocephalus, the annual spend  on hydrocephalus research is relatively low. For example, the US National Institutes of Health (NIH) invests less than US$8m per year in hydrocephalus research. This means that there is a dearth of clinical studies associated with the condition and no long-term follow-up research over the lifetime of patients.
 
Although BASICS is a significant study it should be mentioned that it is restricted by the relatively low proportion of patient-reported outcomes: 32, 31 and 12 reported infections after insertion of the standard, silver and antibiotic VPS’s respectively. 
 
Takeaways
 
This Commentary describes the findings of an important, well-conceived and well-executed clinical study of hydrocephalus. Its importance is derived from the fact that there’s a dearth of large prospective multi-centre randomised controlled clinical studies on hydrocephalus. The study’s findings are significant because they unequivocally suggest that, not only are antibiotic impregnated ventriculoperitoneal shunts more likely to deliver better clinical outcomes, but using them, instead of standard or silver impregnated ventriculoperitoneal shunts, would result in a substantial reduction in healthcare costs.
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6 years, 4 months ago

Age of the aged and low back pain

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  • In high-income countries populations are aging
  • By 2050 the world population of people over 60 is projected to reach 2bn
  • Age-related low back pain is the highest contributor to disability in the world
  • Over 80% of people will experience back pain at some point in their life
  • Older people with back pain have a higher chance of dying prematurely
  • The causes of back pain are difficult to determine which presents challenges for the diagnosis and management of the condition
  • The US $100bn-a-year American back pain industry is “ineffective”
  • Each year 10,000 and 300,000 spine fusion surgeries are carried out in the UK and US respectively
  • 20% of spinal fusion surgeries are undertaken without good evidence
  • In 10 to 39% of spine surgery patients pain continues or worsens after surgeries
 
Age of the aged and low back pain
 
A triumph of 20th century medicine is that it has created the “age of the aged”. By 2050 the world population of people aged 60 and older is projected to be 2bn, up from 900m in 2015. Today, there are 125m people aged 80 and older and by 2050 there is expected to be 434m people in this age group worldwide. The average age of the UK population has reached 40. Some 22% will be over 65 by 2031, and this will exceed the percentage of the UK population under 25. 33% of people born today in the UK can expect to live to 100. However, this medical success is the source of rapidly increasing age-related disorders, which present significant challenges for the UK and other high-income nations. Low back pain (LBP) is the most common age-related pain disorder, and ranked as the highest contributor to disability in the world. 
 
At some point back pain affects 84% of all adults in developed economies. Research published in 2017 in the journal Scoliosis Spinal Disorders suggests that LBP is the most common health problem among older adults that results in pain and disability. The over 65s are the second most common age group to seek medical advice for LBP, which represents a significant and increasing workload for health providers. Each year back pain costs the UK and US Exchequers respectively some £5bn and more than US635bn in medical treatment and lost productivity. LBP accounts for 11% of the total disability of the respective populations. This Commentary discusses therapies for LBP, and describes the changing management landscape for this vast and rapidly growing condition.
 
Your spine and LBP

 

Your spine, which supports your back, consists of 24 vertebrae, bones stacked on top of one another.  At the bottom of your spine and below your vertebrae are the bones of your sacrum and coccyx. Threading through the entire length of your vertebrae is your spinal cord, which transmits signals from your brain to the rest of your body. Your spinal cord ends in your lower back, and continues as a series of nerves, which resemble a horse’s tail, hence its medical name, ‘cauda equine’. Between each vertebra are discs. In younger people discs contain a high degree of water. This gives them the ability to act like shock absorbers. During the normal aging process discs lose much of their water content and degenerate. Such degenerative spinal structures may result in a herniated disc when the disc nucleus extrudes through the disc’s outer fibres, or a compression of nerve roots, which may lead to radiculopathy. This is a condition more commonly known as sciatica, which is pain caused by compression of a spinal nerve root in the lower back that is often associated with the degeneration of an intervertebral disc, and can manifest itself as pain, numbness, or weakness of the buttock and outer side of the leg.

 

Challenges in diagnosis
 
Because your back is comprised of so many connected tissues, which include bones, muscles, ligaments, nerves, tendons, and joints, it is often difficult for doctors to say with confidence what causes back pain even with the help of X-rays and MRI scans. Usually, LBP does not have a serious cause. In the majority of cases LBP will reduce and often disappear within 4 to 6 weeks, and therefore can be self-managed by keeping mobile and taking over-the-counter painkillers. However, in a relatively small proportion of people with LBP, the pain and disability can persist for many months or even years. Once LBP has been present for more than a year few people return to normal activities. There is not sufficient evidence to suggest definitive management pathways for this group that accounts for the majority of the health and social costs associated with LBP.
 
Assessing treatment options for back pain

Ranjeev Bhangoo, a consultant neurosurgeon at Kings’ College Hospital Trust, London, and the London Neurosurgery Partnership describes the nature and role of intervertebral discs and how treatment options should be assessed.

“When a person presents with a problem in the lower back, which might manifest as leg or arm pain, you need to ask 3 questions: (i) is the history of the pain compatible with a particular disc causing the problem?  (ii) Does an examination suggest that a particular disc is causing a problem? And (iii) does a scan show that the disc you thought was the problem is the problem? If all 3 answers align, then there maybe some good reason to consider treatment options. If the 3 answers are not aligned, be weary of a surgeon suggesting intervention because 90% of us will experience back pain at some point in our lives, and 90% of the population don’t need back surgery.”
 
 
Back pain requiring immediate medical attention
 
Although the majority of LBP tends to be benign and temporary, people should seek immediate medical advice if their back pain is associated with certain red flags such as loss of bladder control; loss of weight, fever, upper back or chest pain; or if there is no obvious cause for the pain; or if the pain is accompanied by weakness, loss of sensation or persistent pins and needles in the lower limbs. Also, people with chronic lifetime conditions such as cancer should pay particular attention to back pain.
 
Epidemiology of LBP

Back pain affects approximately 700m people worldwide. A 2011 report by the US Institute of Medicine, estimates that 100m Americans are living with chronic back pain, which is more than the total affected by heart disease, cancer, and diabetes combined. This represents a vast market for therapies that include surgery and the prescription of opioids. Estimates of the prevalence of LBP vary significantly between studies. There is no convincing evidence that age affects the prevalence of back pain, and published data do not distinguish between LBP that persists for more than, or less than, a year. Each year LBP affects some 33% of UK adults, and around 20% of these - about 2.8m - will consult their GP. One year after a first episode of back pain, 62% of people still experience pain, and 16% of those initially unable to work are not working after 1 year. Typically in about 60% of cases pain and disability improve rapidly during the first month after onset.

 

Non-invasive therapies for LBP

The most common non-invasive treatment for LBP is non-steroidal anti-inflammatory drugs (NSAIDs), but also other pain medication may include paracetamol, oral steroids, gabapentin/pregabalin, opioids and muscle relaxants, antidepressants, chiropractic manipulation, osteopathy, epidural injections, transcutaneous electrical nerve stimulation (TENS), ultrasound that uses vibration to deliver heat and energy to parts of the lower back, physiotherapy, massage, and acupuncture.
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Prelude to surgery
 
Despite the range of non-invasive therapies for LBP, the incidence of lumbar spinal fusion surgery for ordinary LBP increased significantly over the past 2 decades without definitive evidence of the efficacy of the procedure. Recent guidelines from UK and US regulatory bodies have instructed doctors to consider more conservative therapies for the management of back pain, and this has resulted in the reduction in the incidence of spinal fusion surgeries.
 
Notwithstanding, because there has been clear recognition of the paucity of evidence for reliable rates of improvement following fusion for back pain surgery, it does not necessarily follow that fusions should never be done and indeed there are many instances where fusions are strongly supported by evidence. The gold standard for diagnosing degenerative disc disease is MRI evidence, which has formed the principal basis for surgical decisions in older adults. However, studies suggest that although MRI evidence indicates that degenerative change in the lumbar spine is common among people over 60, the overwhelming majority do not have chronic LBP.
 
Increasing prevalence of spinal fusion surgery
 
Each year, NHS England undertakes some 10,000 spinal surgeries for LBP at a cost of some £200m, which is in addition to the large and growing number of patients receiving epidurals that cost the NHS about £9bn a year, and they too have low evidence as to their efficacy. In the US more than 300,000 back surgeries are performed each year. In 10 to 39% of these cases, pain may continue or even worsen after surgery; a condition known as ‘failed back surgery syndrome’. In the US, about 80,000 new cases of failed back surgery syndrome are accumulated each year. Pain after back surgery is difficult to treat, and many patients are obliged to live with pain for the rest of their lives, which causes significant disability.
  
Back pain and premature death
 
A study by researchers from the University of Sydney published in 2017 in the European Journal of Pain found that older people with persistent chronic back pain have a higher chance of dying prematurely. The study examined the prevalence of back pain in nearly 4,400 Danish twins over 70. They then compared their findings with the death registry and concluded that, "Older people reporting spinal pain have a 13% increased risk of mortality per year lived, but the connection is not causal." According to lead author Matthew Fernandez, “This is a significant finding as many people think that back pain is not life-threatening.” Previous research has suggested that chronic pain can wear down peoples’ immune systems and make them more vulnerable to disease.
 
Spinal fusion
 
While recognizing that a relatively small group of elite spine surgeons, mostly from premier medical institutions, regularly carry out essential complex surgeries required for dire and paralysis-threating conditions such as traumatic injuries, spinal tumors, and congenital spinal abnormalities, the majority of procedures undertaken by a significant number of spine surgeons have been elective fusion procedures for people diagnosed with pain, which is referred to as “axial”, “functional” and “ non-specific”.  People most likely to benefit from spine surgery are the young, fit and healthy. This is according to a study undertaken by the American Spine Research Association. Notwithstanding, the study also suggests that the typical American candidate for spinal fusion surgery is an overweight, over 55 year old smoker on opioids.
 
Steady growth projected for the spinal fusion market

The spine surgery market is relatively mature and dominated by a few global corporations: Medtronic, DePuy, Stryker, and Zimmer-Biomet. According to a 2017 report from the consulting firm GlobalData the market for spinal fusion, which includes spinal plating systems, interbody devices, vertebral body replacement devices, and pedicle screw systems is set to rise from approximately US$7bn in 2016 to US$9bn by 2023, representing a compound annual growth rate of 3.4%. The increasing prevalence of age-related degenerative spinal disorders, and continued technological advances in spinal fusion surgeries, such as expandable interbody cages and navigation systems, and the increased adoption of minimally invasive techniques, have driven this relatively steady market growth.
 
Spinal fusion surgery

Lumbar spinal fusion surgery has been performed for decades. It is a technique, which unites - fuses - 1 or more vertebrae to eliminate the motion between them. The procedure involves placing a bone graft around the spine, which, over time, heals like a fracture and joins the vertebrae together. The surgery takes away some spinal flexibility, but since most spinal fusions involve only small segments of the spine the surgery does not limit motion significantly.
 
Lumbar spinal fusion

Fusion using bone taken from the patient - autograft - has a long history of use, results in predictable healing, and currently is the “gold standard” source of bone for a fusion. One alternative is an allograft, which is cadaver bone that is typically acquired through a bone bank. In addition, several artificial bone graft materials have been developed, and include: (i) demineralized bone matrices (DBMs), which are created by removing calcium from cadaver bone. Without the mineral the bone can be changed into putty or a gel-like consistency and used in combination with other grafts. Also it may contain proteins that help in bone healing; (ii) bone morphogenetic proteins (BMPs), which are powerful synthetic bone-forming proteins that promote fusion, and have FDA approval for certain spine procedures, and (iii) ceramics, which are synthetic calcium/phosphate materials similar in shape and consistency to the patient’s own bone.
 
Different approaches to fusion surgery

Spinal fusion surgery can be either minimally invasive (MIS) or open. The former is easily marketable to patients because smaller incisions are often perceived as superior to traditional open spine surgery. Notwithstanding, open fusion surgery may be performed using surgical techniques that are considered "minimally invasive", because they require relatively small surgical incisions, and do minimal muscle or other soft tissue damage. After the initial incision, the surgeon moves the muscles and structures to the side to see your spine. The joint or joints between the damaged or painful discs are then removed, and then screws, cages, rods, or pieces of bone grafts are used to connect the discs and keep them from moving. Generally, MIS decreases the muscle retraction and disruption necessary to perform the same operation, in comparison to the traditional open spinal fusion surgery, although this depends on the preferences of individual surgeons. The indications for MIS are identical to those for traditional large incision surgery. A smaller incision does not necessarily mean less risk involved in the surgery.

There are three main approaches to fusion surgery, (i) the anterior procedure, which approaches your spine from the front and requires an incision in the lower abdomen, (ii) a posterior approach is done from your back, and (iii) a lateral approach from your side.
 
Difficulty identifying source of back pain
 
A major obstacle to the successful treatment of spine pain by fusion is the difficulty in accurately identifying the source of a patient’s pain. The theory is that pain can originate from spinal motion, and fusing the vertebrae together to eliminate the motion will get rid of the pain. Current techniques to precisely identify which of the many structures in the spine could be the source of a patient’s back pain are not perfect. Because it can be challenging to locate the source of pain, treatment of back pain alone by spinal fusion is somewhat controversial. Fusion under these conditions is usually viewed as a last resort and should be considered only after other nonsurgical measures have failed.
 
Spinal fusion surgery is only appropriate for a very small group of back pain sufferers

Nick Thomas, also a consultant neurosurgeon at King’s College Hospital Trust, London and the London Neurosurgery Partnership suggests there are a scarcity of preoperative tests to indicate whether spinal lumbar fusion surgery is appropriate, and stresses that spinal fusion is appropriate only for a small group of patients who present with back pain.
 
“The overwhelming majority of patients who present with low back pain will be treated non operatively. In a few very select cases, spinal fusion may be appropriate. A challenge in managing low back pain is that there are precious few pre-operative investigations that give a clear indication of whether a spinal fusion may or may not work. Even with MRI evidence it can be very difficult to determine whether changes in a disc are the result of the normal process of degeneration or whether they reflect a problem that might be generating the back pain. If patients fail to respond to non-operative treatments they may well consider spinal fusion. A very small group of patients, who present with a small crack in one of the vertebrae bones - pars defect - or slippage of the vertebrae - spondylolisthesis - may favorably respond to spinal fusion. In patients where the cause of the back pain is less clear the success rate of spinal fusion is far less.” See video:
 
 
Back pain industry

In a new book entitled Crooked published in 2017, investigative journalist Cathryn Jakobson Ramin suggests that the US $100bn a year back pain industry is, “often ineffective, and sometimes harmful”. Ramin challenges the assumptions of a range of therapies for back pain, including surgery, epidurals, chiropractic methods, physiotherapy, and analgesics. She is particularly damning about lumbar spinal fusion surgery.  In the US 300,000 of such procedures are carried out each year at a cost of about $80,000 per surgery. Ramin suggests these have a success rate of 35%.
 
Over a period of 6 years Ramin interviewed spine surgeons, pain specialists, physiotherapists, and chiropractors. She also met with patients whose pain and desperation led them to make life-changing decisions. This prompted her to investigate evidence-based rehabilitation options and suggest how these might help back pain sufferers to avoid the range of current therapies, save time and money, and reduce their anxiety. According to Ramin people in pain are poor decision makers, and the US back pain industry exemplifies the worst aspects of American healthcare. But this is changing.
 
New Guidelines for LBP
 
In February 2017, the American College of Physicians published updated guidelines, which recommended surgery only as a last resort. Also, it said that doctors should avoid prescribing opioid painkillers for relief of back pain, and suggested that before patients try anti-inflammatories or muscle relaxants, they should try alternative therapies such as exercise, acupuncture, massage therapy or yoga. Doctors should reassure their patients that they would get better no matter what treatment they try. The guidelines also said that steroid injections were not helpful, and neither was paracetamol, although other over-the-counter analgesics such as aspirin or ibuprofen could provide some relief. The UK’s National Institute for Health and Care Excellence (NICE) has also updated its guidelines (NG59) for back pain management. These make it clear that in a significant proportion of back pain surgeries is not efficacious. The new guidelines instruct doctors to recommend various aerobic and biomechanical exercise, NHS England and private health insurers are changing their reimbursement policies. As a consequence the incidence of back surgeries have fallen significantly.
 
In perspective

Syed Aftab, a Consultant Spinal Orthopaedic Surgeon at the Royal London, Barts Health NHS Trust, welcomes the new guidelines, but warns that, “We should be careful that an excellent operation preformed by some surgeons on some patients does not get ‘vilified’. If surgeons stop preforming an operation because of the potential of being vilified, patients who could benefit from the procedure lose out”.
 
Surgical cycle

“There seems to be a 20-year cycle for surgical procedures such as lumbar fusion. The procedure starts, some patients benefit and do well. This encourages more surgeons to carry out the procedure. Over time, indications become blurred, and the procedure is more widely used by an increasing number of surgeons. Not all patient do well. This leads to surgeons being scrutinized, some vilified, the procedure gets a bad name, surgeons stop preforming the operation, and patients who could benefit from the procedure lose out,” says Aftab, who is also a member of Complex Spine London, a team of spinal surgeons and pain specialists who focus on an evidence based multidisciplinary approach to spinal pathology.
 
Takeaway
 
LBP is a common disabling and costly health challenge. Although therapies are expensive, not well founded on evidence, and have a relatively poor success rate, their prevalence has increased over the past 2 decades, and an aging population does not explain this entirely. Although the prevalence of lumbar spinal fusion surgery has decreased in resent years, the spine has become a rewarding source of income for global spine companies, and also there have been allegations of conflicts of interest in this area of medicine. With the new UK and US guidelines the tide has changed, but ethical questions albeit historical still should be heeded.
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