Why not consider establishing an NHS Endobarrier Service at your Hospital?

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Roy Carpenter
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1 Why not consider establishing an NHS Endobarrier Service at your Hospital? Dr Bob Ryder, Consultant Diabetologist, SWBH, Birmingham, ABCD Autumn Meeting, Brighton, November 10, 2016

2 Endobarrier implantable duodenal-jejunal liner Fluoropolymer wall Nitinol Anchor Roux-en-Y gastric bypass surgery 60 cm impermeable sleeve Minimally invasive

$In-Phase Out of phase Baseline Fat fraction 22.$ $4% 4-months post-endobarrier Fat fraction 0.$

3 Summary Liver fat pre- and post-mr images In-Phase Out of phase Baseline Fat fraction 22.4% 4-months post-endobarrier Fat fraction 0.5% Data presented at DDW 2016, San Diego USA, May 2016

4 MRI analysis: Summary mean fat fraction (n8) (Impact of four months Endobarrier treatment) Hepatic fat: 14.9 ± 9.4% to 2.9 ± 4.5%, p=0.003 Pancreatic fat: 6.9 ± 8.5% to 1.3 ± 8.9%, p=0.02 Data presented at DDW 2016, San Diego USA, May 2016

5 First 25 NHS Service patients baseline characteristics Parameter n=25 Age (years) ±7.5 Sex (% male) 56.0 Ethnicity (% Caucasian) 44.0 *Diabetes duration (yrs) 12.0 ( ) Taking insulin (%) 60.0 *median(interquartile range)

6 Summary NHS Endobarrier service at SWBH (n=25) Parameter Baseline 1 year Difference P-value, n=25 Weight (kg) 118.5± ± ± BMI (kg/m 2 ) 41.1± ± ± HbA1c (mmol/mol) 81.2± ± ± HbA1c (%) 9.6± ± ± Systolic Blood Pressure 137.7± ± ± ALT 32.0± ± ± Total Daily Insulin Dose* [median(iqr),n=15] 104(60-135) 12(0-65) *NB 6 of the 15 (40%) patients were able to discontinue insulin

7 Independent Endobarrier Worldwide Registry established About to go live

7 kg/m 2 HbA1c 58 mmol/mol (7.5%) Weight 115.

8 Research patient Before 12 months After HbA1c 109 mmol/mol (12.1%) Weight kg BMI 44.7 kg/m 2 HbA1c 58 mmol/mol (7.5%) Weight kg =Weight loss 21.9 kg (nearly 3.5 stone) BMI 37.6 kg/m 2

9 Research patient Before 12 months After HbA1c 77 mmol/mol (9.2%) Weight = kg BMI = 35.3 kg/m 2 Insulin 100 units HbA1c 40 mmol/mol (5.8%) Weight 80.0 kg =Weight loss 25.6 kg (over 4 stone) BMI 26.7 kg/m 2 Insulin no longer required

10 NHS service patient Before 12 months After HbA1c 61 mmol/mol (7.7%) Weight = 86.6 kg BMI = 35.1 kg/m 2 Obstructive sleep apnoea requiring CPAP HbA1c 43 mmol/mol (6.1%) Weight = 65.6 kg =weight loss 21.0kg (over 3 stone) BMI = 26.2 kg/m 2 CPAP no longer required

Before NHS service patient 12 months After HbA1c 76 mmol/mol (9.1%) Weight = 116.

0 kg/m 2 Insulin 42units daily Idiopathic interstitial pneumonitis requiring ambulatory

11 Before NHS service patient 12 months After HbA1c 76 mmol/mol (9.1%) Weight = kg BMI = 38.0 kg/m 2 Insulin 42units daily Idiopathic interstitial pneumonitis requiring ambulatory oxygen therapy HbA1c 49 mmol/mol (6.6%) Weight = 88 kg =Weight loss 28.4 kg (4.5 stone) BMI = 28.8 kg/m 2 Insulin no longer required Ambulatory oxygen therapy no longer required

12 Before NHS service patient 12 months After HbA1c 70 mmol/mol (8.6%) Weight = 82.9 kg BMI = 33.6 kg/m 2 (Obese BMI) HbA1c 51 mmol/mol (6.8%) Weight = 62.2 kg =Weight loss 20.7 kg (over 3 stone) BMI = 24.7 kg/m 2 (Normal BMI)

ml/min/1.73m 2 HbA1c = 50 mmol/mol (6.7 %) Wt = 73 kg = weight loss 19.

13 NHS service patient Before 12 months After HbA1c = 69 mmol/mol (8.5 %) Wt = 92.4 kg BMI = 36 kg/m 2 Insulin 147 units daily Creatinine 153 umol/l egfr 30 ml/min/1.73m 2 HbA1c = 50 mmol/mol (6.7 %) Wt = 73 kg = weight loss 19.4 kg (3 stone) BMI = 27 kg/m 2 Insulin no longer required Creatinine 106 umol/l egfr 46 ml/min/1.73m 2

57mmol/mol (7.4%) Wt = 76.8kg =Weight loss 21.4 kg (well over 3 stone) BMI = 24.

14 NHS service patient Before 12 months After HbA1c = 64mmol/mol (8%) Wt = 98.2kg BMI = 31.3kg/m 2 (Obese BMI) Insulin 80 units daily Professional driver (Taxis, would like HGV) HbA1c = 57mmol/mol (7.4%) Wt = 76.8kg =Weight loss 21.4 kg (well over 3 stone) BMI = 24.2kg/m 2 (Normal BMI) Insulin no longer required Now off insulin so can drive heavy goods vehicles without issue which was his ambition

15 NHS service patient Before 12 months After HbA1c 128 mmol/mol (13.9%) Weight = 102 kg BMI = 39.3 kg/m 2 (Obese BMI) Insulin 260 units HbA1c 49 mmol/mol (6.6%) Weight 64.2 kg =Weight loss 37.8 kg (nearly 6 stone) BMI kg/m 2 (Normal BMI) Insulin no longer required

16 To maintain 260 units of insulin/day she required to use 316 insulin pens per year =

17 1,095 blood glucose tests/year ( 440 = cheapest) 1,460 pen needles/year ( 89.25) 1,095 lancing devices/year ( 71.06) 3 sharps bins for sharps disposal/year ( 35)

18 Before NHS service patient 12 months After Insulin 260 units = cost /year NO Insulin = Cost saving /year

19 Establishing an NHS Summary Endobarrier Service - requirements Enthusiasm, entrepreneurial spirit, dogged determination Ideally your local senior management on board Friendly local endoscopists Get your CCG on board

20 Summary The funding arrangement in Birmingham: We have agreed with our commissioner a two-fold charge, being; a) The application of a standard national tariff for the endoscopy procedure to insert Endobarrier, and again the same code for removal of Endobarrier code FZ71C. ( 790) b) Agreement of a Local Variation that tops up the national tariff value by the pass through cost of the Endobarrier device. ( 3300 including VAT) NB this is NHS funding speak

21 To discuss further by all means contact me:

These patients are typical of our Endobarrier treated patients. The ones we included here are often the ones demonstrating additional benefits over

These patients are typical of our Endobarrier treated patients. The ones we included here are often the ones demonstrating additional benefits over above weight and HbA1c. 12 months After HbA1c 109 mmol/mol