In October 2007, the Foresight report, Tackling Obesities: Future Choices, predicted that if no action was taken, 60% of men and 50% of women would be obese by 2050. More recently, the report Healthy Lives, Healthy People: a call to action on obesity in England revealed that the UK is yet to see signs of a sustained decline in this worrying trend, while health inequalities relating to obesity also continue to pose a challenge. According to figures from the Department of Health,1 a total of 23% of adults are obese (with a body mass index [BMI] of over 30); while 61.3% are either overweight or obese (with a BMI of over 25). Some 23.1% of 4-5 year-olds are overweight or obese, while the figure for 10–11-year-olds is even higher at 33.3%.1 Obesity not only presents a major risk factor for diseases such as type 2 diabetes, cancer and heart disease, it also has financial implications for the NHS – excess weight is reported to cost the health service more than £5 bn each year.1 In April 2011, the first audit from the National Bariatric Surgery Registry found that bariatric surgery could be used as an alternative and cost-effective treatment to prevent a number of obesity-related health problems including type 2 diabetes.
The audit, which looked at data from 8,710 operations, found that 85.5% of people, who had type 2 diabetes prior to surgery. had seen an improvement in their condition after two years. The audit suggested that, by the time severely obese patients reach surgery, around two thirds have three or more associated diseases, while one in ten have five or more. A third will have high blood pressure; over a quarter have diabetes; nearly a fifth have high cholesterol and one sixth will suffer from sleep apnoea. As well as losing, on average, 57.8% of excess weight, improvement was recorded in all associated disease at 12 months follow-up (See Table 1). The audit concluded that long-term sufferers (some of whom have had the disease for more than ten years), take the longest to go into remission – highlighting the need to operate early on in the disease progression to obtain the best health gains for patients. The audit further highlighted the fact that obesity surgery had, so far, demonstrated a good safety record in the UK – reporting an in-hospital mortality rate of just 0.1%, which compares favourably with other forms of established surgery. More recently, the National Bariatric Surgery Registry findings were supported by research presented at the American College of Cardiology’s 61st Annual Scientific Session.2 Bariatric or ‘metabolic’ surgery was found to be more effective than intensive medical management, alone, in managing uncontrolled type 2 diabetes, for overweight or obese patients, after one year. People with uncontrolled diabetes have a much higher risk of cardiovascular complications, including heart attack, stroke and the development of secondary complications like neuropathy, retinopathy and amputation. Patients undergoing one of two stomach-reducing procedures – either laparoscopic gastric bypass or sleeve gastrectomy – in addition to medical therapy were three to four times more likely to achieve glycaemic control (a measure of diabetes control defined using HbA1c) after one year of treatment compared to those who only received intensive medical therapy.
A randomised controlled trial, STAMPEDE compared the effect of these two procedures to intensive medical therapy in helping patients achieve target goals. Although the American Diabetes Association recommends an HbA1c of less than 7%, researchers set a more aggressive (6.0%) target as a primary endpoint for the trial. This was achieved in 12.2% of the medical treatment group versus 42.0% for gastric bypass (P=0.002) and 36.7% for sleeve gastrectomy (P=0.008). In addition, people in the surgical groups had a much larger reduction in their HbA1c (2.9 vs 1.4 points), significantly greater weight loss, and reduced reliance on medications compared to those receiving medical therapy alone. “For about a century, we have been treating diabetes with pills and injections and this is one of the first studies to show that surgical therapy may, at least in some patients, be much more effective than the polypharmacy approach to treating this disease,” said Philip Schauer, the study’s lead investigator and director of the Bariatric and Metabolic Institute at the Cleveland Clinic. “It is a potential paradigm change. In patients with moderate to severe diabetes, medication therapy alone can only get them so far; they are often still well above the target of good glycaemic control.” A total of 150 patients (49±8 years, 66% female) were randomly assigned to one of three treatment groups: intensive medical therapy only, which includes a combination of counseling, lifestyle changes and medications; medical therapy plus Roux-en-Y gastric bypass; or medical therapy plus sleeve gastrectomy. Sleeve gastrectomy entails removing part of the stomach to reduce its volume by 75% to 80%; gastric bypass in the simplest terms involves two operations, the first to reduce the stomach to 2% to 3% of its usual volume (going from the size of a football to a golf ball) and the second to connect the new gastric pouch directly into the intestine to bypass the stomach. All patients had some degree of obesity (BMI of 27 to 43 kg/m2). Secondary outcomes included safety and adverse event rates, measures of glycaemic control, weight loss, co-morbidity status and cardiovascular risk profile. At 12 months, glycaemic control improved in all three groups with a mean HbA1c of 7.5% ±1.8, 6.4% ±0.9, and 6.6% ±1.0 for medical therapy, gastric bypass and sleeve gastrectomy, respectively. In general, there were no major differences in blood pressure and cholesterol control between the groups.
Patients in the surgical groups saw a significant improvement in glycaemic control and were able to dramatically reduce the number of glucose, cholesterol and blood pressure-lowering medications they were taking. Medication use generally increased for those in the medical treatment group. “Even though patients were given very intensive treatment, including new drugs, the surgical therapies were still superior,” said Dr Schauer. “The improvement in patients undergoing surgery was so rapid that many were able to come off their medications before leaving the hospital.” Weight loss was five times greater for patients who received gastric bypass or sleeve gastrectomy compared with medical therapy (roughly 55 to 64 pounds compared to 12 pounds). Dr Schauer said the findings suggest that even those patients who are not severely obese (those with a BMI of 27, for example), may benefit from surgery in much the same way as those with a higher BMI. He added that surgery is not without risks, however. There was, as expected, a higher rate of complications in the surgery groups – although there were no related deaths or life-threatening or debilitating complications. The most common issues were short-term dehydration, bleeding and one leak. Four out of 100 surgical patients needed operative intervention to manage complications occurring within the 12-month follow-up period.
Cardiovascular benefits
According to a study, published in JAMA earlier this year, bariatric surgery also reduces long-term incidence of cardiovascular deaths and events, such as heart attack and stroke.3 Lars Sjöström, M.D., Ph.D., of the University of Gothenburg, Sweden, and colleagues, tested the hypothesis that bariatric surgery is associated with a reduced incidence of cardiovascular events. The study (Swedish Obese Subjects [SOS]) is an ongoing, non-randomised, prospective, controlled study conducted at 25 public surgical departments and 480 primary healthcare centres in Sweden, and includes 2,010 obese participants who underwent bariatric surgery and 2,037 matched obese controls who received usual care. Patients aged 37 to 60 years, with a BMI of at least 34 in men and at least 38 in women, were included in the study and underwent gastric bypass (13.2%), banding (18.7%), or vertical banded gastroplasty (68.1%). The average changes in body weight after 2, 10,15, and 20 years were -23%, -17%, -16%, and -18% in the surgery group and 0%, 1%, -1%, and -1% in the control group respectively. Follow-up showed that there were 49 cardiovascular deaths among the patients in the control group and 28 cardiovascular deaths among the patients in the surgery group. In total (fatal and non-fatal), there were 234 cardiovascular events among patients in the control group and 199 cardiovascular events among patients in the surgery group. Bariatric surgery was associated with a reduced number of fatal heart attack deaths (22 in the surgery group vs 37 in the control group), as well as a reduction in total heart attack incidence. It was also associated with a reduced number of fatal stroke events and total stroke events.
Cognitive improvement
Research also suggests that there may be other surprising health benefits associated with bariatric surgery. John Gunstad, an associate professor in Kent State University’s Department of Psychology, and a team of researchers also found a link between weight loss and improved memory and concentration.4 A study carried out by the researchers showed that patients exhibited improved memory function after bariatric surgery. The research team studied 150 participants (109 bariatric surgery patients and 41 obese control subjects) at Cornell Medical College and Weill Columbia University Medical Center, both in New York, and the Neuropsychiatric Research Institute in Fargo, N.D. Many bariatric surgery patients exhibited impaired performance on cognitive testing, according to the study’s report. The researchers discovered that bariatric surgery patients demonstrated improved memory and concentration 12 weeks after surgery, improving from the slightly impaired range to the normal range.
Psychological impact
While there is a growing body of evidence highlighting the health benefits arising from bariatric surgery, careful consideration also needs to be given to the psychological impact of surgery, according to researchers from the University of the West of England and Southmead Hospital, Bristol.5 The researchers followed 25 patients, aged from 30 to 58 years and recorded their experience 12 months after receiving a post-laparoscopic gastric banding operation. Some 64% of the participants had type 2 diabetes. Although the people who took part in the study reported significant health benefits such as improved blood glucose levels and lower cholesterol and blood pressure levels, they also found that living with the gastric band had a strong, negative psychological impact on their daily lives. The majority reported that having a gastric band was as hard as having to diet and that losing the opportunity to eat as a coping strategy left them struggling to cope with distressing life events. Lead researcher, Dr Andrew Johnson, from Southmead Hospital, said the findings showed that having a gastric band should not be seen as ‘the easy option’ when it comes to losing weight. “This operation has a strong psychological impact as well as a physical one and we found that regular psychological support is needed to help people cope with the realities of having the device fitted,” he commented. Diabetes UK subsequently issued a statement that surgery ‘should only be considered if sustained attempts to lose weight through diet and lifestyle changes have been unsuccessful’, adding that patients need to be made aware of the psychological consequences of having the procedure, when considering surgery.5
Access to surgery
Currently, NICE guidelines state that people with a BMI of 40, or more or those with a BMI of 35 plus associated diseases, should be considered for surgery. While a large number of patients may be eligible, and wish to have an operation, many are denied access to bariatric surgery on the NHS – despite a growing body of evidence, highlighting the positive effects on health outcomes. The Royal College of Surgeons (RCS) has spoken out against the ‘postcode lottery’ encountered by patients and has called for national action – stating that ‘lives are being lost due to local delegation of a key health policy’.6,7 In particular, it stresses that only a fraction of those severely obese patients who are eligible can access treatment – despite the fact that economic analysis has found that surgery pays for itself within a year.8,9 The RCS reported that constraints on NHS funding mean that, in some areas, NHS decision makers opt to ignore professional guidelines and deny patients access to surgery. In addition, it has claimed that patients, who already meet the criteria, are being forced to wait until either they become more obese or develop life-threatening illness such as diabetes or stroke. While some care providers adhere to NICE guidelines, others raise the bar so that only the most extremely ill patients – those with a BMI of 50 or 60 with obesity related illness – are referred for surgery. The RCS pointed out that there is no clinical evidence to support this practice. In fact, evidence suggests that not only do these patients have less to gain from surgery but are far more likely to suffer serious complications. An anonymous survey of UK bariatric surgeons, conducted by the RCS, found that approximately two thirds of surgeons said patients, who were eligible under NICE guidelines were refused surgery in their centres.7 A report by the Office of Health Economics (for the Royal College of Surgeons of England, National Obesity Forum, Allergan and Covidien) concluded that failure by the NHS to provide costeffective surgical treatment for morbid obesity is costing the wider economy hundreds of millions of pounds a year.9 The analysis concluded that:
• If just 5% of NICE-eligible patients were to receive bariatric surgery, the total net gain to the economy within three years would be £382 m.
• If 25% of NICE-eligible patients were to receive bariatric surgery, the total net gain to the economy within three years would be £1.3 bn.
• The UK Government could also expect savings in benefit payments in the region of £35 m-£150 m.
• Direct healthcare cost savings of around £56 m per annum to the NHS in reduced prescriptions and GP visits if NICE guidance was followed.
Nevertheless, figures from the NHS Information Centre show an upward trend in the number of patients undergoing bariatric surgery. The number of hospital procedures for weight-loss stomach surgery rose to 8,087 in 2010/11 – 12% higher than in 2009/10 when there were 7,214. In the last decade, procedures saw a 30-fold increase from just 261 in 2000/01 to the current level – though figures for more recent years also include procedures carried out to maintain an existing gastric band rather than fit a new one. Of the 8,087 procedures for weight-loss bariatric surgery carried out in 2010/11, 1,444 were, in fact, for maintenance of an existing band.10 Ultimately, the increasing number of morbidly obese patients undergoing surgery will present the health service with some practical challenges, along with important safety issues for patients, as well as staff. These issues will be examined in CSJ as part of a series of articles focusing on bariatric patient care. Some important developments are also anticipated, later this year, which will have a significant influence on the way care is delivered – including the publication of the ‘Bariatric Surgery Study’ by the National Confidential Enquiry into Patient Outcome and Death (NCEPOD). The findings from this report will help identify variability and remediable factors in the process of care for patients undergoing bariatric surgery, and CSJ will be reporting on the results as they become available. :
References
1 Department of Health, Healthy Lives, Healthy People: A call to action on obesity in England. 13 October 2011. 2 Dr Schauer, Comparison of Bariatric Surgical Procedures and Advanced Medical Therapy for the Treatment of Type 2 Diabetes in Patients with Moderate Obesity: 1 Year STAMPEDE Trial Results, presented Monday, 26 March 2012 at the American College of Cardiology’s 61st Annual Scientific Session. Study simultaneously published in the New England Journal of Medicine and released online at the time of presentation. 3 Lars Sjöström et al. Bariatric Surgery and Long-term Cardiovascular Events, The Journal of the American Medical Association (JAMA); January 2012. 4 News release accessed online www.kent.edu/CAS/Psychology/news/newsd etail.cfm?newsitem=4B46DFCA-EB9E- 874D-A51FCA7489071C80, April 2011. 5 Research presented at the Diabetes UK Annual Professional Conference, 4 March 2010. Press release: Weight loss surgery can lead to psychological distress. Accessed at www.diabetes.org.uk 6 Royal College of Surgeons. Press release: College response to NHS Information Centre press release on obesity surgery. 10 February 2010. Accessed at: www.rcseng.ac.uk 7 Conference of UK bariatric surgeons, held at the Royal College of Surgeons of England. 21 January 2010. Source: press release: Conference hears of ‘unfair and unethical’ access to NHS weight loss surgery. Accessed at: www.rcseng.ac.uk 8 RCS comment on NHS Obesity statistics. 24 February 2011. Accessed at: www.rcseng.ac.uk 9 Office of Health Economics. Shedding The Pounds: Obesity Management. NICE Guidance And Bariatric Surgery In England; September 2010. 10 NHS Information Centre. Statistics on obesity, physical activity and diet: England. 2012, 23 February 2012. Accessed at: www.ic.nhs.uk/pubs/opad12