1. Centro per lo Studio, la Ricerca E la Terapia dell’Obesità C.S.R.T.O. Direttore: dott. Pietro Pizzi Policlinico di Monza. Via Amati 111. 20052 Monza E-mail: pietro.pizzi@policlinicodimonza.itpietro.pizzi@policlinicodimonza.it pietro_pizzi@libero.it

2. XXICONGRESSO NAZIONALE S.I.C.O.B. Società Italiana di Chirurgia dell’Obesità e Malattie Metaboliche CAGLIARI - 25-27 APRILE 2013 Policlinico di Monza. Via Amati 111. 20052 Monza E-mail: pietro.pizzi@policlinicodimonza.itpietro.pizzi@policlinicodimonza.it pietro_pizzi@libero.it

3. BMI-EWL trends, short and long-term slippages in patients operated with the new-HAGA LAGB(Heliogast System) for morbid obesity, according to four different techniques. Definitive results (follow-up 48 months)in a pilot prospective randomized study. P.Pizzi*, A:Alberti*, G.De Lorenzis**, M.Pizzi* * Centro per lo Studio, la Ricerca e la Terapia dell’Obesità (C.S.R.T.O.). Policlinico di Monza ** Centro dell’Obesità. Casa di Cura Città di Parma Centro per lo Studio, la Ricerca e la Terapia dell’Obesità. C.S.R.T.O. Direttore dott. P.Pizzi

4. XVII Congresso S.I.C.O.B. – Roma 2009 BMI-EWL trends, short and long-term complications in 154 patients operated with the new-HAGA LAGB(Heliogast System) for morbid obesity, according to four different techniques. A pilot prospective randomized study. P.Pizzi*, A:Alberti*, D.Lochis*, G.De Lorenzis**, G.Mari***, M.Pizzi*** * Centro per lo Studio, la Ricerca e la Terapia dell’Obesità (C.S.R.T.O.). Policlinico di Monza ** Centro dell’Obesità. Casa di Cura Città di Parma *** Università degli Studi di Milano Centro per lo Studio, la Ricerca e la Terapia dell’Obesità. C.S.R.T.O. Direttore dott. P.Pizzi

5. 5 Methods 1 154 patients enrolled were randomly assigned to four groups according to the different surgical techniques: 1.“pars flaccida tech” with anterior fixation pts. 38 2.“pars flaccida tech” without anterior fixation pts. 39 3.“two-steps perigastric tech” with anterior fixation pts. 39 4. “two-steps perigastric tech” without anterior fixation pts. 38 Centro per lo Studio, la Ricerca e la Terapia dell’Obesità. C.S.R.T.O. Direttore dott. P.Pizzi

6. Methods 2 Long-term study (24 months) 132 consecutive patients operated with the new-HAGA LAGB (Heliogast Sustem) Between September 2008 to Mars 2009 Centro per lo Studio, la Ricerca e la Terapia dell’Obesità. C.S.R.T.O. Direttore dott. P. Pizzi Long-term study (48 months) 120 consecutive patients operated with the new-HAGA LAGB (Heliogast Sustem) Between September 2008 to Mars 2009

7. Results 1 Preliminary study 154 pts. 27:127 = M:F Mean age 38.7 M (18-53) 40.3 F (16-66) International HAGA results : 6658 pts. 39.3 M (16-68) 41.2 F (16-71) Centro per lo Studio, la Ricerca e la Terapia dell’Obesità. C.S.R.T.O. Direttore dott. P. Pizzi Long-term study (24 months) 132 pts. 17:115 = M:F Mean age 38.6 M (18-53) 40.2 F (16-66)

8. Results 2 Long-term study (36 months December 2011) 128 pts. 15:113 = M:F Mean age 38.4 M (18-53) 40.1 F (16-66) Centro per lo Studio, la Ricerca e la Terapia dell’Obesità. C.S.R.T.O. Direttore dott. P. Pizzi Long-term study (48 months December 2012) 120 pts. 12:108 = M:F Mean age 38.2 M (18-53) 40.2 F (16-66)

9. Results 3 Preliminary study 154 pts. 27:127 = M:F Mean BMI 44.6 M 42.1 F International HAGA results : 6011 pts. 43.2 M 42.9 F Centro per lo Studio, la Ricerca e la Terapia dell’Obesità. C.S.R.T.O. Direttore dott. P. Pizzi Long-term study (24 months December 2010) 132 pts. 17:115 = M:F Mean BMI 30.7 M 29.2 F

10. Results 4 Long-term study (36 months December 2011) 128 pts. 15:113 = M:F Mean BMI 30.6 M 28.8 F International HAGA results : 6658 pts. 32.4 M 29.6 F Centro per lo Studio, la Ricerca e la Terapia dell’Obesità. C.S.R.T.O. Direttore dott. P. Pizzi Long-term study (48 months December 2012) 120 pts. 15:113 = M:F Mean BMI 30.4 M 28.9 F Internetional HAGA results: 8254 pts. 32.5 M 29.5 F

11. Results 5 Preliminary study (6 months) 154 pts. 27:127 = M:F Mean EWL evaluation at 3 months on 107 pts. 17.3 M : 18.1 F International HAGA results : 6235 pts. 17.1 M 17.8 F Mean EWL evaluation at 6 months on 39 pts. 27.7 M : 31.3 F International HAGA results : 6011 pts: 27.0 M 29.0 F Centro per lo Studio, la Ricerca e la Terapia dell’Obesità. C.S.R.T.O. Direttore dott. P. Pizzi Long-term study (18 months) 147 pts. 24:123 = M:F Mean EWL evaluation at 12 months on 147 pts 41.6 M : 46.9 F International HAGA results : 6328 pts. 42.1 M 45.6 F Mean EWL evaluation at 18 months on 147 pts. 49.3 M : 54.5 F International HAGA results: 6500 pts. 48.5 M 53.8 F

12. Results 6 Long-term study (24 months December 2010) 132 pts. 17:115 = M:F Mean EWL evaluation at 12 months on 147 pts 41.6 M : 46.9 F International HAGA results : 6328 pts. 42.1 M 45.6 F Mean EWL evaluation at 24 months on 132 pts. 49.8 M : 54.7 F International HAGA results: 6658 pts. 42.1 M 45.6 F Centro per lo Studio, la Ricerca e la Terapia dell’Obesità. C.S.R.T.O. Direttore dott. P. Pizzi Long-term study (48 months December 2012) 128 pts. 15:113 = M:F Mean EWL evaluation at 36 months on 128 pts 49.7 M : 54.9 F International HAGA results : 6658 pts. 49.1 M 53.9 F Mean EWL evaluation at 48 months on 120 pts. 49.7 M : 54.9 F International HAGA results: 8254 pts. 49.0 M 53.8 F

13. Results 7 Long-term study (24 months) 132 pts. 17:115 = M:F Slippage 3 pts. Female 1° pt.: 8 months after surgery 2° pt.: 9 months after surgery 3° pt.:20 months after surgery 1 pt. Male 4° pt.:15 months after surgery Centro per lo Studio, la Ricerca e la Terapia dell’Obesità. C.S.R.T.O. Direttore dott. P. Pizzi Long-term study (24 months December 2010) 1° pt. (F): “pars flaccida” technique without anterior fixation 2° pt. (F): “two-steps perigastric” technique without anterior fixation 3° pt. (F): “pars flaccida” technique without anterior fixation 4° pt. (M): “two-steps perigastric” technique without anterior fixation

14. Results 8 1° pt. (F): slippage 8 months after surgery September 2008: band placement BMI 41.7 May 2009: slippage with gastric obstruction (BMI 30.1) and band re-placement October 2009: new slippage without gastric obstruction (BMI 34.5) and indication for RYGBP Centro per lo Studio, la Ricerca e la Terapia dell’Obesità. C.S.R.T.O. Direttore dott. P. Pizzi 2° pt. (F): slippage 9 months after surgery December 2008: band placement BMI 43.6 September 2009: slippage with subtotal gastric obstruction (BMI 33.8) and band re-placement December 2010 (BMI 26.9)

15. Results 9 3° pt. (F): slippage 20 months after surgery January 2009: band placement BMI 44.3 September 2010: slippage with subtotal gastric obstruction (BMI 27.2) and band re-placement December 2010 (BMI 26.7) Centro per lo Studio, la Ricerca e la Terapia dell’Obesità. C.S.R.T.O. Direttore dott. P. Pizzi 4° pt. (M): slippage 15 months after surgery Mars 2009: band placement BMI 42.9 June 2010: slippage with subtotal gastric obstruction (BMI 26.8) and band re-placement December 2010 (BMI 26.5)

16. Conclusions 1 Preliminary study (6 months) In our study the new-HAGA LAGB (Heliogast System) for morbid obesity is a safe and well reproducible procedure for all the four different techniques we used. In all groups we found an efficacy in the BMI and EWL trends at 3 and 6 months. Our results were similar or even better than the International HAGA LAGB results. Centro per lo Studio, la Ricerca e la Terapia dell’Obesità. C.S.R.T.O. Direttore dott. P. Pizzi Long-term study (24 months December 2010) 132 pts. 17:115 = M:F 3 pts. Female and 1 pt. Male with complications (slippage) 1° pt.(F): 8 months after surgery 2° pt.(F): 9 months after surgery 3° pt.(F):20 months after surgery 4°pt.(M):15 months after surgery

17. Conclusions 2 Long-term study (24 months December 2010) From Mars 2009 to December 2010 we operated of new-HAGA LAGB (Heliogast System) 528 patients: 513 pts. with “pars flaccida”technique and anterior fixation 15 pts. with “two-steps perigastric” technique and anterior fixation Centro per lo Studio, la Ricerca e la Terapia dell’Obesità. C.S.R.T.O. Direttore dott. P. Pizzi Long-term study (24 months) From Mars 2009 to December 2010 we operated of new-HAGA LAGB (Heliogast System) 528 patients: all patients with anterior fixation. NO SLIPPAGES extra study group

18. Conclusions 3 Long-term study (36 months December 2011) 128 pts 15:113 = M:F From September 2008 to December 2011 we operated with the new- HAGA LAGB (Heliogast System) 912 patients for morbid obesity. 8 pts. (study group of 154 pts.) with slippages (1 pt. with anterior fixation and 7 pts. without anterior fixation). 3 pts. (extra study group of 154 pts.) with slippages ( all with anterior fixation and old HAGA). Long-term study (24 months December 2010) From September 2008 to December 2010 we operated with the new-HAGA LAGB (Heliogast System) 682 patients for morbid obesity 4 pts. (study group of 154 pts.) with slippages (all pts. without anterior fixation).

19. Conclusions 4 Long-term study slippages (24 months December 2010) 132 pts. 17:115 = M:F 3 pts. Female and 1 pt. Male with complications (slippage) 1° pt.(F): 8 months after surgery 2° pt.(F): 9 months after surgery 3° pt.(F):20 months after surgery 4°pt.(M):15 months after surgery Centro per lo Studio, la Ricerca e la Terapia dell’Obesità. C.S.R.T.O. Direttore dott. P. Pizzi Long-term study slippages (36 months December 2011) 128 pts. 15:113 = M:F December 2010 4 pts. (3 F, 1 M) without anterior fixation December 2011 1 pts. (M) with anterior fixation 3 pts ( 2M, 1F) without anterior fixation

20. Conclusions 5 Long-term study slippages (36 months December 2011) 128 pts. 15:113 = M:F 4 pts. Female and 4 pt. Male with complications (slippage) 1° pt.(F): 8 months after surgery 2° pt.(F): 9 months after surgery 3° pt.(M):15 months after surgery 4°pt.(F):20 months after surgery 5° pt.(M):22 months after surgery 6° pt.(M):23 months after surgery 7° pt. (F): 29 months after surgery 8° pt.(M):31 months after surgery Centro per lo Studio, la Ricerca e la Terapia dell’Obesità. C.S.R.T.O. Direttore dott. P. Pizzi Long-term study slippages (48 months December 2012) 120 pts. 12:108 = M:F From September 2008 to December 2012 we operated with the new- HAGA LAGB (Heliogast System) 1193 patients for morbid obesity. 2 pt. Female with complications (slippage, all without anterior fixation and “pars flaccida” technique)

21. Conclusions 6 Long-term study slippages (48 months December 2012) 120 pts. 12:108 = M:F From September 2008 to December 2012 we operated with the new- HAGA LAGB (Heliogast System) 1193 patients for morbid obesity. 2 pt. Female with complications (slippage, all without anterior fixation and “pars flaccida” technique) Centro per lo Studio, la Ricerca e la Terapia dell’Obesità. C.S.R.T.O. Direttore dott. P. Pizzi Long-term study slippages (48 months December 2012) 120 pts. 12:108 = M:F 10 slippages 9 pts. without anterior fixation 1 pt. with anterior fixation

22. Conclusions 7 From October 2010 we utilize an stitch under new-HAGA between the gastric greater curvature, gastric body and lesser gastric curvature. We feel that this technique decrease the number of slippages. We performed a randomized study in 100 patients operated with the new-HAGA (Heliogast System) LAGB for morbid obesity with “pars flaccida” technique, all without anterior fixation: 50 pts. with stitch and 50 pts. without stitch under band. A longer follow-up will give us the chance to evaluate the incidence of slippages.

24. Conclusions 8 Possible causes of slippage Patient’s compliance missing Gastric banding structure Gastric banding with anterior fixation Gastric banding without anterior fixation Gastric pouch to big Etcetera !!!!!!!!

25. Centro per lo Studio, la Ricerca E la Terapia dell’Obesità C.S.R.T.O. Direttore: dott. Pietro Pizzi Policlinico di Monza. Via Amati 111. 20052 Monza E-mail: pietro.pizzi@policlinicodimonza.itpietro.pizzi@policlinicodimonza.it pietro_pizzi@libero.it