Maurizio De Luca MD Department of Surgery – Regional Hospital of Vicenza – Italy XXI Congresso...

Maurizio De Luca MD

Department of Surgery – Regional Hospital of Vicenza – ItalyDepartment of Surgery – Regional Hospital of Vicenza – Italy

XXI Congresso Nazionale SICOB

Cagliari, 25-27 Aprile 2013

La Gestione degli insuccessi del calo ponderale in Chirurgia Bariatrica

Strategie di Trattamento dopo fallimento di Bendaggio Gastrico

Maurizio De Luca MD Executive SurgeonGeneral Secretary of Italian Society of Bariatric SurgeryEmail: [email protected]

2

LAGB – first choice for obesity surgery


Laparoscopic Adjustable Gastric Banding Development phase (pre-2000) Established phase (post-2000)

Significant numbers received perigastric implants

All pars-flaccida

Laparoscopic surgery in its infancy – few surgeons with experience

Advanced laparoscopic techniques well established and widely disseminated

No specialist obesity surgery centres Many internationally recognised Centres of Excellence

Early band technology – high failure rates due to leakage, erosions and tubing/access port probems.

Improved band engineering and design, eliminating previous problems and offering innovations – eg development of rapid fixation technology for access port

Little experience with band adjustment, erosion, pouch dilatation, prolapse etc

Greater recognition of perils of over-adjustment and need for close follow-up and early intervention when problems arise.

Two phases of LAGB development

Authors Size of

cohort

Duration of

follow-up

Implantation Operative

mortality

Port/tubing

problems (e.g.

leakage &

infection)

Slippage/pouch

dilatation

Erosion

%

Re-operation

rate

% EWL

Pre-2000

Tolonen et al 280 7 years PF 0 10.6% 6.5% 3.3% 24.4% 56% at 7 years

Steffen et al 824 5 years PF 0 6.8% 2.7% 1.6% Major 16.5%

(minor 6.8%)

57% at 5 years

Chevallier et al 1,000 7 years PG 37.8%

PF 62.2%

0 5.7% 10.4% 0.3% 11% Not reported

Zehetner et al 190 6 years PF 0 2.6% 2.6% 2.1% 8.5% 50% after 2 ys

Toouli et al 1,000 8 years PG 4.2%

PF 95.8%

0 6.7% 3.0% 3.1% 14.5% 52% at 8 years

Chevallier et al 400 2 years PG 94.5%

PF 5.5%

0 7.5% 8.5% 0% 8.8% 52.7% at 2

years

Zinzindohoue et

al [36]

500 3 years PG 77.4%

PF 22.6%

0 7.8% 8.6% 0% 10.4% 54.8% at 3

years

Ceelen et al 625 3 years PG 0 2.9% 5.6% 0% 7.8% 47.4%

Gastric Banding Studies before 2000

Authors Size of

cohort

Duration of

follow-up


mortality

Port/tubing

problems (e.g.

leakage &

infection)

Slippage/pouch

dilatation

Erosion

%

Re-operation

rate

% EWL

Pre-2000

Favretti et al 1,791 12 years PG 77.8%

PF 21.5%

0 11.2% 3.9% 0.9% 5.9% 38.5% at 10 years

Vertruyen et al 543 7 years PG 0 2.9% 4.6% 0.9% 6.8% 52% at 7 years

Michelleto et al 684 5 years PG 47%

PF 53%

0 6.8% 6.1% 1% 6.3% 54% at 5 years

Weiner R et al 984 8 years RG 58.7%

Mixed 41.3%

0 2.5% 4.5% 0.3% 3.9% 59.3% after 8 years

O’Brien et al 709 6 years PG 0 3.6% 12.5% 2.8% 18.9% 57% at 6 years

Belachew et al 763 4 years PF 0.1% 2.6% 7.7% 0.9% 10.5% 50-60% at 4years +

Dargent et al 1,180 7 years PG/PF (not stated) 0.16% N/S 8.8% 1.8% 12.7% 50% at 7 years

Mittermair et al 454 3 years PF 0 9.7% 2.0% 3.1% 7.9% 72% at 3 years

Balsiger et al 196 7 years PF 0 7.5% 12% 1% 32% 61% at 7 years

Gastric Banding Studies before 2000

Authors Size of

cohort

Duration of

follow-up


mortality

Port/tubing

problems (e.g.

leakage &

infection)

Slippage/pouch

dilatation

Erosion

%

Re-operation

rate

% EWL

Post-2000

Ponce et al 1,014 4 years PG 4.3%

PF 95.7%

0 1.2% 2.3% 0.2% 8 bands

explanted

64.3% at 4

years

Ren et al 445 1 year PF 0.2% 2.2% 3.1% 0.2% 7.2% 44.3% at 1

year

Parikh et al 749 3 years PF 0 2.4% 2.9% 0.1% 10.7% 52% at 3 years

Holloway et al [41] 500 3 years PF 0.2% 9.2% 5.0% 1.0% n/s 65% at 3 years

Sarker et al 409 3 years PF 0.2% 4.2% 5.4% 0.2% 12.2% 53.3% at 3 yrs

Gastric Banding Studies after 2000


Gastric BandingStudies Before vs After the year 2000 : difference?

50-60 %EWL before and after 2000

Steffen 57%EWL 824 pts 5 yBelachew 55%EWL 763 pts 4y before 2000Parikh 52%EWL 749 pts 3y after 2000Ponce 64%EWL 1014pts 4y

Efficacy – Weight Loss

Steffen R, Biertho L, Ricklin T, et al (2003). Laparoscopic Swedish adjustable gastric banding: a five-year prospective study. Obes Surg 13:404-411

Belachew M, Belva PH, Desaive C (2002) Long-term results of laparoscopic adjustable gastric banding for the treatment of morbid obesity. Obes Surg 12:564-568

Parikh MS, Fielding G, Ren CJ (2005) US experience with 749 laparoscopic adjustable gastric bands: Intermediate outcomes. Surg Endosc 19:1631-1635

Ponce J, Paynter S, Fromm R

Laparoscopic adjustable gastric banding: 1,014 consecutive cases. J Am Coll Surg 201:529-535 2005


137 studies (33 SAGB and 104 LAGB) – 29980 Patients

3-Year mean weight loss was 53.3%

Cunneen SA, Phillips E, Fielding G et al. Studies of Swedish adjustable gastric band and Lap-band: systematic review and meta-analysis. Surg Obes Relat Dis 2008; 4: 174-85

Efficacy – Weight Loss

LAGB vs RYGBP – long-term outcomesSystematic review of medium-term weight loss after bariatric operationsEvaluation of 43 reports fulfilled the entry criteria (18 RYGBP; 18 LAGB; 7 BPD)

%EWL%EWL

Years of Follow UpYears of Follow Up

O’Brien PE et al. Obes Surg 2006; 16:1032-1040



No significant difference in Operative Mortality

Steffen 0% 824 pts 5 yFavretti 0.% 1791 pts 12 yBelachew 0.1% 763 pts 4y before 2000Parikh 0% 749 pts 3y after 2000Ren 0.2% 445 pts 1y

Operative Mortality


Favretti F, Segato G, Ashton D, et al (2007) Laparoscopic adjustable gastric banding in 1,791 consecutive obese patients: 12-year results. Obese Surg 17:168-175


Parikh MS, Fielding G, Ren CJ (2005) US experience with 749 laparoscopic adjustable gastric bands: Intermediate outcomes. Surg Endosc 19:1631-1635

Ren CJ, Weiner M, Allen RW (2004) Favourable early results of gastric banding for morbid obesity: The American experience. Surg Endosc 18:543-546


137 studies (33 SAGB and 104 LAGB) – 29980 Patients

early mortality ≤0.1%

Cunneen SA, Phillips E, Fielding G et al. Studies of Swedish adjustable gastric band and Lap-band: systematic review and meta-analysis. Surg Obes Relat Dis 2008; 4: 174-85

Operative Mortality



Drammatically lower stomach slippage rate from Perigastric tecnique vs pars Flaccida tecnique

Ponce 20.5% in PG vs 1.4%

O’Brien four time higher in PG

Stomach Slippage

Ponce J, Paynter S, Fromm R Laparoscopic adjustable gastric banding: 1,014 consecutive cases. J Am Coll Surg 201:529-535 2005

O’Brien, PE, Dixon JB, Anderson M . A prospective randomized trial of placement of the laparoscopic adjustable gastric band: comparison of the perigastric and pars flaccida pathways. Obes Surg;15:820-6 2005



No significant difference in Gastric Erosion Rate

Chevallier 0% 400 pts 2 yFavretti 0.9% 1791 pts 12 yTolonen 3.3% 280 pts 7 y before 2000Watkins 0.1% 2411 pts 3y after 2000Singhal 0.09% 1140 pts 3y

Gastric Erosion

Chevallier JM, Zinzindohoue F, Douard R, et al (2004) Complications after laparoscopic adjustable gastric banding for morbid obesity: Experience with 1,000 patients over 7 years. Obes Surg 14:407-414


Tolonen P, Victorzon M, Makela J (2008). 11-year experience with laparoscopic adjustable gastric banding - What happened to the first 123 patients? Obes Surg 18: 251-255

Watkins BM, Ahroni JH, Michaelson R, et al (2008) Laparoscopic adjustable gastric banding in an ambulatory surgery center. Surg Obes Rel Dis 4 (Suppl):S56-62 Singhal R, Kitchen M, Ndirika S, et al (2008) The “Birmingham” stitch” - Avoiding slippage in laparoscopic gastric banding. Obes Surg 18:359-363



Less common rate due to improved band design and surgical technique

Mittermair 9.7% 454 pts 3 yFavretti 11% 1791 pts 12 yTolonen 10.6% 280 pts 7 y before 2000Parikh 0%s 749pts 3y after 2000Singhal 0.35% 1140 pts 3y

Port Tubing leakage and infection

Mittermair RP, Weiss H, Nehoda H, et al (2003) Laparoscopic Swedish adjustable gastric banding: 6-year follow-up and comparison to other laparoscopic bariatric procedures. Obes Surg 13:412-417



Watkins BM, Ahroni JH, Michaelson R, et al (2008) Laparoscopic adjustable gastric banding in an ambulatory surgery center. Surg Obes Rel Dis 4 (Suppl):S56-62 Singhal R, Kitchen M, Ndirika S, et al (2008) The “Birmingham” stitch” - Avoiding slippage in laparoscopic gastric banding. Obes Surg 18:359-363



Drammatically reduced due to improved band design and surgical technique

Steffen major 16.5% - minor 6.8% 824 pts 5yBelachew 10.5% 763 pts 4 y Tolonen 24,4% 280 pts 7 y before 2000Sarker 2.6%s 7409 pts 3y after 2000Singhal 2.1% 1140 pts 3y

Reoperation Rate




Sarker S, Myers J, Serot J, et al (2006) Three-year follow-up weight loss results for patients undergoing laparoscopic adjustable gastric banding at a major university medical center: Does the weight loss persist? Am J Surg 191:372-376

Singhal R, Kitchen M, Ndirika S, et al (2008) The “Birmingham” stitch” - Avoiding slippage in laparoscopic gastric banding. Obes Surg 18:359-363



Reduced to the surgical skill

Vertruyen MMicheletto G 60-150 minDargent J before 2000Watkins 40 min after 2000

Length of procedure

Vertruyen M (2002) Experience with Lap-Band system up to 7 years. Obes Surg 12: 569-572 Micheletto G, Roviaro G, Lattuada E, et al (2006) Adjustable gastric banding for morbid obesity. Our experience. Ann Ital Chir 77:397-400

Dargent J (1999) Laparoscopic adjustable gastric banding: Lessons from the first 500 patients in a single institution. Obes Surg 9:446-452

Watkins BM, Ahroni JH, Michaelson R, et al (2008) Laparoscopic adjustable gastric banding in an ambulatory surgery center. Surg Obes Rel Dis 4 (Suppl):S56-62



Reduced up to ambulatory basis

Vertruyen MMicheletto G 3-4 daysDargent J before 2000Watkins ambulatory after 2000Coburn

Hospital Stay

Vertruyen M (2002) Experience with Lap-Band system up to 7 years. Obes Surg 12: 569-572 Micheletto G, Roviaro G, Lattuada E, et al (2006) Adjustable gastric banding for morbid obesity. Our experience. Ann Ital Chir 77:397-400

Dargent J (1999) Laparoscopic adjustable gastric banding: Lessons from the first 500 patients in a single institution. Obes Surg 9:446-452

Watkins BM, Ahroni JH, Michaelson R, et al (2008) Laparoscopic adjustable gastric banding in an ambulatory surgery center. Surg Obes Rel Dis 4 (Suppl):S56-62

Coburn C et al. Laparoscopic Gastric Banding is Safe in Outpatient Surgical Centres. Obes Surg 2010; Published Online, January.



Efficacy – Weight Loss in extreme cases

Torchia F, Mancuso V et al (2008) LapBand system® in super-superobese patients (>60 kg/m2): 4-year results. Obes Surg [Epub ahead of print]

. Fielding GA, Duncombe JE (2005) Laparoscopic adjustable gastric banding in severely obese adolescents. Surg Obes Relat Dis 1:399-405 52. Taylor CJ, Layani L (2006) Laparoscopic adjustable gastric banding in patients > or + 60 years old: Is it worthwhile? Obes Surg 16:1579-1583

Different Studies show that there are not differences in terms of safety and efficacy in Super-obese, Adolescents and Elderly Pts


LAGB– long-term outcomes

0 operative mortality

91% follow-up with 5.9% re-operation rate

Mean EWL% at 10 years was approximately 40%

9


Kg 1307

976 819 690 612 523 381 269 197 125 48 12 3

484

374

317 274 242 204 151 113 70 4115

3

Laparoscopic Gastric Banding for 1800 Patients: 12 Years Results

Results in Super e Morbid Obese (BMI)



Results in Super e Morbid Obese (% EWL)

%EWL

1307

976 819 690612

523 381 269 197 12548

12

3

484

374

317 274

242 204 151 113 70 41 153



Major Complications Requiring Reoperation (106/1791 pts.; Sept 1993-Dec 2005)

Complications Number Rate of Complications

Reoperation Number Rate of Reoperation

Stomach Slippage +

Pouch Dilatation

70 3.9% • Removal • Repositioning

20

50

1.1%

2.8%

Erosion 16 0.9% Removal 16 0.9%

Psychological Intolerance

14 0.7% Removal 14 0.7%

Miscellaneous

(HIV, Infections, Microperforation)

5 0.27% Removal 5 0.27%

Gastric Necrosis 1 0.05% Gastrectomy 1 0.05%

Total 106 5.9% Total 106 5.9%

Unsatisfactory Results

(Lack of Compliance)

41 2.3% • BPD• Removal• “BandInaro”

5

12

24

0.27%

0.7%

1.3%


Lap-Band Patients: No Responders


… about “no responders”….

Strategie di trattamento dopo fallimento di Bendaggio Gastrico


No Responders

• Gastric Bypass and Functional Gastric Bypass

• Sleeve Gastrectomy

• Scopinaro or Duodenal Switch

• Mini Gastric Bypass


Sleeve GastrectomyVicenza Series

14 Patients (December 2006 to January 2008)

F/M 9/5

14 cases of remedial surgery

5-6 green and blue staple cartridge after full devascularization and mobilization af the greater gastric curve

Running suture by 3-0 Prolene over-sewed the staple-line

Mean operative time was 95 min (70-135)

No peri-operative or post-operative complication

No mortality

cccccccccccccccccccc


Maurizio De Luca

Gastric Bypass

Small gastric pouchRoux –en-Y gastrointestinal anastomosis

Food Intake reductionEarly satietyPost-prandial discomfortPartial lipid malabsorption

Functional Bypass

Maurizio De Luca

Bilio Pancreatic Diversion

BilioPancreatica Diversion (Scopinaro 1976)

distal gastrectomy gastric reservoir 200-300 mlcommon channel 50 cmalimentary channel 200 cm

Maurizio De Luca

Bilio Pancreatic Diversion

BilioPancreatic Diversion Duodenal Switch (Hess 1988)

vertical gastrectomy gastric reservoir 150-200 mlduodenal switchcommon channel 100cmalimentary channel 150 cm


Effects of BPD on comorbidities.

Scopinaro N, Adami FA, Marinari GM et al. BilioPancreatic Diversion: Two Decades of Experience. Update: Surgery for the Morbidly Obese Patient. F-D Communication. Deitel M, Cowan G, 2000, Chap 23, 227-258


Duodenal Switch

Complication (Hess: 440 pts.)

Medical perioperative complicationDeep vein thrombofiblitis 0.75%Non-fatal pulmonary embolism 0.5%Pneumonia 0.5%ARDS 0.25%

Surgical ComplicationSplenectomy (incidental) 0.75%Duodenal Leak 1.5%Distal Roux-en-Y Leak 0.25%Post-op bleeding (requiring surgery) 0.5%Abscess (not related to leaks) 0.25%

Late Surgical complicationDuodenal stoma obstruction 0.75%Small Bowel obstruction 1.5%

Hess DS. Biliopancreatic Diversion with Duodenal Switch. Obes Surg. 8, 267-282, 1998


Nutrients Most at Risk

Iron

Calcium

Zinc

VitaminD

Vitamin A

Vitamin K

Protein

Dolen K et al. A clinical and nutritional comparison of biliopancreatic diversion with and without duodenal switch. Ann Surg 2004; 240-51

Slater GH, Serum fat-soluble vitamin deficiency and abnormal calcium metabolism after malabsorptive bariatric surgery. J Gastrointestinal Surg 2004; 8: 48-65


BPD Standad and BPD DS prevalence side-effects

Marceau P., Hould F, Lebel S et al. Malabsorbitive Obesity Surgery. The Surgical Clinics of North America. 2001, 81,5, 1113-1127

.

(p<0.0001 by Fisher t-test)

Maurizio De Luca

Less surgery compared with GBP and BPD

Low peri-operative comorbidities compared with GBP and BPD

Long Term Weight Loss as BPD (75% EWL at 10 yrs)

Resolution or improvement of Diabetes in 89% of Pts at 7 yrs

Resolution of hyperlipidemia in 92% of Pts at 7 yrs

Absence of BPD side effects (like diarrhea, hemorrhoids, proctitis etc.)

Absence metabolic side effects of BPD (protein malnutrition)

20-30 ml Gastric pouch

One gastro-jejunal anastomosis with a diameter of 1.5-2 cm

L-L anastomosis and non T-L anastomosis

Antireflux Stitches

Omega Loop 200-220 cm (different mechanism of Billroth II)

Antecolic anastomosis (avoiding holes in the mesocolon)

Mini Gastric BypasOmega Loop Long Limb Gastric Bypass Single Anastomosis

One Anastomosis Gastric Bypass: a simple, safe and efficient surgical procedure for treating morbid obesityM Garcia Caballero and M CarbajoNutricion Hospitalaria, XIX, (6) 372-375, 2004


BARIATRIC SURGERY Sequential Treatment

LAP BAND

Treated

(72% of pts)

Undertreated

Malabsorption

Treated(Comorbiditie

s)


BARIATRIC SURGERY Sequential Treatment

LAP BAND Treated

(72% of pts)

Undertreated

Single Anastomosis Omega Loop Gastric Bypass

Malapsorbitive procedure

No compliant Patients


The majority of Studies shows that LAGB is a safe and effective procedure

Operative mortality of 0-0.1%

Excess Weight Loss (%EWL) of 50-60%

Commensurate to this degree of weight loss, almost all studies show substantial improvements in obesity related comorbidities such as Hypertension, Type II Diabetes,and Dyslipidemia

LAGB has been shown to be both safe and effective in super-obese, adolescents, older patients

Conclusion 1


The lessons from the development phase (before 2000) of LAGB taught , in the estabilished phase (after 2000), surgical techniques and band technologies

There is no agreement, to date, regarding:1. LAGB indications2. role of the multidisciplinary team3. algorithm of band inflation

Redo Surgery in case of failure of LAGB is easy to be performed(sleeve gastrectomy, gastric bypass, mini gastric bypass, BPD)

Conclusion 2

3 parameters of paramount importance for:• further weight loss• further reduction of reoperation rate

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Maurizio De Luca MD Department of Surgery – Regional Hospital of Vicenza – Italy XXI Congresso...

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