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Il ruolo del blocco vagale nel trattamento dell’obesità e delle sue comorbidità.

Il ruolo del blocco vagale nel trattamento dell’obesità e delle sue comorbidità. Luca Busetto Dipartimento di Medicina - Università di Padova Clinica Medica 1 – Unità Bariatrica. Nervo Vago: Un elemento del sistema di regolazione del bilancio energetico. Ghrelin GLP-1/PYY.

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Il ruolo del blocco vagale nel trattamento dell’obesità e delle sue comorbidità.

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  1. Il ruolo del blocco vagale nel trattamento dell’obesità e delle sue comorbidità. Luca Busetto Dipartimento di Medicina - Università di Padova Clinica Medica 1 – Unità Bariatrica

  2. Nervo Vago: Un elemento del sistema di regolazione del bilancio energetico. Ghrelin GLP-1/PYY

  3. Nervo Vago: Un potenziale target per il trattamento dell’obesità. • 20% dellefibrevagalisono EFFERENTI • (dal SNC allostomaco) • MOTORIE • Secrezioneacidagastrica • Secrezioneenzimidigestivi • Capacitàgastrica • Svuotamentogastrico • SENSITIVE • Fame • Sazietà • Metabolismoenergetico • Regolazionepressoria • 80% dellefibrevagalisono AFFERENTI • (dallostomaco al SNC)

  4. Kral JG. Vagotomy for treatment of severe obesity. Lancet 1978;30:307. • Kral JG, Görtz L, Hermasson G, et al. Gastroplasty for obesity: long-term • weight loss improved by vagotomy. World J Surg 1993;17:75. • - Boss TJ, Trus T, Peters JH, et al. Laparoscopic truncal vagotomy for weight-loss • a prospective, dual center safety and efficacy study. Surg Endosc 2008;22:S146. • Angrisani L, Cutolo PP, Ciciriello MB, et al. Laparoscopic adjustable gastric • banding with truncal vagotomy versus laparoscopic adjustable gastric banding • alone: interim results of a prospective randomized trial. SOARD 2009;5:435. • Martin MB, Erle KR. Laparoscopic adjustable gastric banding with truncal • vagotomy: any increased weight loss? Surg Endosc 2011;25:2522. Kral JG et al. World J Surg 2009;33:1995

  5. VBLOC TherapyDelivered via the Maestro System • VBLOC Therapy: Bloccovagaleintermittentedurante le ore di veglia • erogato da un pacemaker impiantatosottocutetramite due elettrodi • fissatiallabrancaanteriore e posteriore del nervovago a livellodella • giunzione gastro-esofagea.

  6. VBLOC TherapyDelivered via the Maestro System

  7. VBLOC Therapy: procedura

  8. Protein Carbohydrates Fat Earlier Fullness and Less Hunger Reduced Portion Size Reduced Calories 30 % EWL from Implant Earlier fullness 2250 2000 1750 20% 1500 1250 20% Change from Baseline (%) 22% 43% Calories (kcal %) 23% Change from Baseline (%) 1000 Reduced hunger 44% 40% 750 41% 500 37% 36% 38% 250 36% 40 Pre-implant 4 weeks 6 months 12 weeks Therapy Initiation 0 4 weeks 12 weeks 6 months Pre-implant 4 weeks 12 weeks 6 months (n=10) (n=10) (n=8) (n=9) Camilleri M et al. Surgery 2008;143:723

  9. Sarr MG et al. ObesSurg 2012;22:1771

  10. %EWL 17±2 vs 16±2 % Sarr MG et al. ObesSurg 2012;22:1771

  11. Sarr MG et al. ObesSurg 2012;22:1771

  12. Week 2 Week 4 12 Months Baseline BP 145/89 145/89 145/89 Reduction in Blood Pressure (mmHg) Systolic Blood Pressure Diastolic Blood Pressure Ending BP 128/80 128/81 127/79 Sarr MG et al. ObesSurg 2012;22:1771

  13. Intermittent neural transmission block of the intra-abdominal vagus induces sustained blood pressure reduction in obese subcjets. Tweden KS et al. AHA 2012 Abstr 13195

  14. VBLOC Therapy2^ generation device • ReCharge Study • (2011-2016) • Randomized controlled trial in 233 obese patients • Builds on previous trial learning; Similar design to EMPOWER trial and uses ENABLE device learning • 2nd Generation device which averages 12+ hours use • No charge will be delivered to vagus nerve in the control group • Endpoints: • Greater EWL for Treated v. Control • Responder Analysis • Safety • Unblinding expected EOY 2012; announce results Q1 2013 EMPOWER Trial (2008-2013) Randomized controlled trial in 294 obese patients • 1st Generation RF device • Endpoints: • Greater EWL for Treated v. Control • Responder Analysis • Safety • Results: • Safety results were excellent • An unanticipated therapeutic effect appeared to have been delivered to patients in the control arm thus comparative efficacy endpoint not met • Dose effect -Clinically significant weight loss in patients who used the device ≥ 9 hours per day in treated and control groups

  15. RECHARGE Study: Safety Results No deaths, no unanticipated adverse device effects. Implant/revision procedure, device, therapy-related SAEs in treated subjects (primary safety endpoint): 3.1% vs. 15% pre-specified limit, CI (1.0 - 7.1%); p<0.0001. 93% of subjects were active in the blinded trial at 12 months.

  16. RECHARGE Study: Efficacy ResultsMean %EWL in ITT population.

  17. RECHARGE Study

  18. RECHARGE Study: Efficacy ResultsResponders Analysis in ITT Population.

  19. RECHARGE Study:Efficacy results in Per Protocol Population.

  20. Il blocco intermittente della trasmissione nervosa a livello del vago intra-addominale è associato ad un significativo calo ponderale. Il calo ponderale con questa metodica è risultato significativamente superiore al placebo in uno studio randomizzato controllato. La tecnica appare sostanzialmente sicura e gli effetti collaterali molto ridotti. Possono esservi effetti sulla pressione indipendenti dal calo ponderale. VBLOC Therapy: Conclusioni

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