Debate Vaginal surgery for POP -To mesh

Transcription

1 Debate Vaginal surgery for POP -To mesh 吳銘斌 Ming-Ping Wu 1,2, Director, Div. Urogynecology & Pelvic Floor Reconstruction, Dept. Obstetrics and Gynecology 1, Chi Mei Foundation Hospital, Tainan, Taiwan; College of Medicine, Taipei Medical University 2, Taipei, Taiwan

2 Pelvic organ prolapse (POP) 個案 & 待解決的問題 子宮脫垂合併膀胱及直腸膨出 傳統的治療方式就是子宮切除 Q1: 難道患有子宮脫垂就一定要切除子宮嗎? Q2: 切除了子宮, 脫垂現象就會完全改善嗎? Q3: 萬一 以後膀胱再脫垂時怎麼辦呢?

3 Pre-OP POP-Q Post-OP Pre-Op Bump RC 1996 AJOG Post-op 3 mons

4 Classification pelvic reconstructive surgery Anterior compartment Anterior repair/ paravaginal repair + prosthestic reinforcement Continence surgery ± sling, Burch colposuspension, bulking agents Middle compartment Abdominal hysterectomy+ sacrocolpopexy Vaginal hysterectomy+ iliococcygeus/ sacrospinous fixation+ prosthestic reinforcement Abdominal or vaginal sacrospinous/ sacrohysteropexy Posterior compartment Posterior repair + prosthestic reinforcement Rectopexy Anal sphincter repair Birch C 2002 Curr Opin Obstet Gynecol

5 Why do we need prostheses in pelvic reconstructive surgery? The high recurrence rate after surgery for pelvic organ prolapse (POP) makes the more refined reconstructive surgery imperative High failure rate 30% (Olsen AL 1997 Obstet Gynecol) The long-term anatomic outcomes of traditional cystocele repair High failure rate 37% (Quiroz LH 2006 Contemp Ob/Gyn) Therefore, biological and synthetic prostheses merged as adjuvant materials.

6 Reasons for surgical failure Poor patient selection Suboptimal surgical technique Inappropriate choice of suture materials Persistence of predisposing risk factors Poor tissue quality Impaired healing Chronic increased intra-abdominal pressure due to COPD, asthma, or constipation High-grade cystocele Age 60 or above Whitesides JL 2005 Obstet Gynecol Surv

7 vagina Pelvic support pubovervical f. rectum bladder ATFP Sacro-spinous lig vagina Rectovaginal f. rectum bladder

8 Pelvic organ prolapse (POP) X It breaks but not attenuates!!!

9 Key questions considering prosthetic materials 1) Does it improve the function of the repair? 2) Does it improve the durability of the repair? 3) Does the graft increase the rate of complication?

10 History of prosthesis Inguinal hernia repair in general surgery 43% recurrence in the suture repair group 24% in the mesh augmented repair group Luijendij R 2000 NEJM History of synthetic non-absorbable prostheses 1903 metallic silver mesh 1938 Nylon 1956 Dacron (Mersilene) 1958 polypropylene (Marlex)

11 Advantages of prostheses the surgeon can repair all vaginal defects faster and with less effort. Well anatomic support anterior compartment, anchored to ATFP Level II attachment Posterior compartment, to the level of the ischial spine, level I support. (DeLancey 1992 JOL Am J Obstet Gynecol) Concomitant surgery POP + SUI using different shaped materials.

12 The purposes of prosthesis in pelvic reconstructive surgery The purposes of prostheses in pelvic reconstructive surgery are to substitute the lacking supportive tissue, to reinforce the inadequate tissue, to generate new supportive tissue, to consolidate the insufficient surgical technique.

13 The Evolution of Pelvic Reconstructive Surgeries Abdominal sacrocolpopexy± mesh Tension-free vaginal mesh + procedural kits* Vaginal repair of anterior, posterior compartment + mesh??? Biologic materials** Sacro-spinous lig. suspension VTH+ A-P colporrhaphy *Prolift (J&J); Perigee+Apogee (AMS); post. IVS (Tyco); Nazca (Promedon) **SIS (Cook); Pelvicol (Bard) Huang KH & Wu MP Incont Pelvic Floor Dysfunc

14 Ideal prostheses Must Have better in vivo response than autologous tissue Be chemically inert Be able to be modeled in the required shape Be able to sterilized Be resistant to infection Must not Physically modified by tissue fluids Induced an inflammatory reaction or antibodies Be carcinogenic Induce allergy or hypersensitvity Promote adhesion at the surface of contact or viscera Cossen M 2003 Int Urogyn J

15 The different prostheses in pelvic reconstructive surgery Baessler & Maher 2006 Curr Opin Obs Gyn

16 The comparison of the microscopic appearance of synthetic prostheses. Birch C 2005 Best Proc Res Clin Obstet Gynecol

17 Classification of Synthetic Prostheses Type Fiber type Pore size I Monofilament macroporous > 75µ component polypropylene Brand names Prolene (Ethicon) Marlex (Bard) Atrium (Atrium) II monofilament microporous < 10µ eptfe Gore-Tex (Gore) III Multifilament micro/macroporous polyethylene Mersilene (Ethicone) Teflon (Dupont) SurgiPro (Tyco) IV submicronic < 1µ polypropylene sheet Silastic (Dow Corning) Cellgard (Hoescht) Birch C 2002 Curr Opin Obstet Gynecol

18 Different Synthetic Prostheses

19 Classification of absorbable synthetic & biologic prostheses Type Fiber type Pore size component Brand names absorbable Xenograft Allograft Autologous mono/ multifilament Multi filament Polypropyle/ polyglactin 910 Polyglactin 910 Porcine small intestine Bovine pericardium Dura mater Fascia lata Rectus shealth Fasica lata Vaginal mucosa Vypro (Ethicone) Vicyl (Ethicone) SIS (Cook) Pelvicol (Bard)

20 The Evolution of Pelvic Reconstructive Surgeries Sacro-spinous lig. suspension Vaginal repair of anterior, posterior compartment + mesh Abdominal sacrocolpopexy± mesh Biologic materials** Tension-free vaginal mesh ± procedural kits* VTH+ A-P colporrhaphy Huang KH & Wu MP Incont Pelvic Floor Dysfunc

21 Abdominal sacro-colpopexy with synthetic mesh: surgical outcomes Birch C Fynes MM 202 Curr Opin Obstet Gynecol

22 Abdominal sacro-colpopexy with synthetic mesh: surgical outcomes A systematic review of 98 articles success rates for apical support of % support of all segments of % [Nygaard IE 2004 Obstet Gynecol ]. Synthetic rather than biological prostheses randomized trial polypropylene mesh (91% cure) better than cadaveric fascia lata (68% cure) (p= 0.007) at 1 year follow-up in favor of the polypropylene mesh group at POP-Q points Aa and C, as well as overall prolapse stages, sig. [Culligan PJ 2005 Obstet Gynecol].

23 The Evolution of Pelvic Reconstructive Surgeries Sacro-spinous lig. suspension Vaginal repair of anterior, posterior compartment + mesh Abdominal sacrocolpopexy± mesh Biologic materials** Tension-free vaginal mesh ± procedural kits* VTH+ A-P colporrhaphy Huang KH & Wu MP Incont Pelvic Floor Dysfunc

24 Anterior compartment repairs with prosthetic reinforcement Sig. Sig. The available data on permanent synthetic prostheses sparse, small, retrospective series, short-term follow-up. Birch C 2005 Best Practice & Research

25 Anterior vaginal wall prolapse repair with nonabsorbable mesh high anatomical cure rates polypropylene meshes 87%, 91.6%, 100% (Salvatore S 2002 Neurourol Urodyn, de Tayrac R 2005 J Reprod Med, Milani R et al BJOG) with relatively high mesh erosion rates 8.3%, 13% (de Tayrac R et al J Reprod, Salvatore S al Neurourol Urodyn, Med, Milani R et al BJOG) Worsening dyspareunia anterior mesh repair, 20% posterior mesh repair 63% (Milani R et al BJOG) Comparable incidence of de novo dyspareunia In patients with (9%) without (11%) vaginal erosion (p=0.85) (Deffieux X et al Int Urogyn J)

26 How do you read this?

27 The Evolution of Pelvic Reconstructive Surgeries Abdominal sacrocolpopexy± mesh Biologic materials** Tension-free vaginal mesh ± procedural kits* Vaginal repair of anterior, posterior compartment + mesh Sacro-spinous lig. suspension VTH+ A-P colporrhaphy *Prolift (J&J); Perigee+Apogee (AMS); post. IVS (Tyco); Nazca (Promedon) Huang KH & Wu MP Incont Pelvic Floor Dysfunc

28 Advantages of procedural kits-i Simple and efficient surgical technique Reduced surgery time Short learning curve Simple and precise transfer of the anchoring arms. Simplified tension-free system

29 Advantages of procedural kits-ii Improved tissue integration Macroporous polypropylene mesh promotes tissue in-growth and minimizes erosion and exposition risk. Anatomically-designed needle system Minimally invasive needles enable easy and accurate placement. The handle s ergonomic design provides optimal control over the needle s insertion.

30 Gynecare Prolift Pelvic Floor Repair System

31 Gynecare Prolift Pelvic Floor Repair System Anterior incision

32 The Perigee System American Medical Systems, Minnetonka, MN, USA

33 Nazca POP repair system Nazca TC Prepubic Approach + Transobturator Approach Promedon (Cordoba, Argentina)

34 Options TVM +/- TVT-O A B TVT-O Ant. Prolift or Perigee Post. Prolift or Apogee or post IVS Preserved uterus Gynecare, J&J AMS; Tyco Hysterectomized

35 TVM- Prolift A retrospective multicentric study (N=106), perioperative and immediate post-operative results, Success rate: 95.3% (failure rate 4.7%) recurrent prolapse even asymptomatic or low grade symptomatic prolapse Mesh exposure 4.7% (5/110) 2/ 5 required a surgical management Prolift seems to be a safe technique to correct POP. However, anatomical and functional results of a long-term follow-up has not yet to confirm the effectiveness and safety of the procedure [Fatton B 2006 Int Urogyn J].

36 Mesh erosion or migration Current available mesh polypropylene 0.5%, polyethylene terephthalate (Mersilene) 3.1% (J&J) Gore-Tex 3.4% (Gore) polyethylene 5.0% (Marlex) (Bard) Teflon 5.6% (DuPont) Nygaard IE 2004 Obstet Gynecol. Huang KH & Wu MP Incont Pelvic Floor Dysfu

37 Mesh erosion due to different materials Type II, III : 20 30% woven, multi-filamentous in nature limited host-tissue ingrowth leading to erosions, draining sinuses, and fistulae. (Debodinance P et al Eur J Obstet Gynecol Reprod Biol ],[Julian TM 1996 Am J Obstet Gynecol) 17% intravaginal slingplasty (Tyco.) (Siegel AL et al J Urol) Type I: 0.5-5% (Fatton B et al Int Urogyn J)

38 Mesh erosion due to different Approach approaches abd. sacro-colpopexy 3.2% sacral colpoperineopexy 4.5% Suture vaginally, introduce mesh abd. 16% Introduce mesh vaginally 40% (Visco AG 2001 Am J Obstet Gyneol) Techniques Erosion 17.5% 2.7% in the avoidance of T-shaped colpotomies, concomitant hysterectomy and perineal incision (Debodinance P 2004 J Gynecol Obstet Biol Reprod)

39 Take-home message-1 The high recurrence rate after surgery for pelvic organ prolapse (POP) makes the more refined reconstructive surgery mandatory. The prostheses are viewed as a scaffold for tissue in-growth and not as a permanent bridge. The use of synthetic prostheses is well established in sacro-colpopexy, controversial for repair of anterior and posterior wall defects.

40 Take-home message-2 Synthetic prostheses may have slightly higher success rates but higher erosion rate biologic materials: better tolerated & lower erosion rate. Which prostheses (synthetic or biological) is superior in vaginal surgery currently: inconclusive Ideal prostheses with various characters are not available currently, synthetic non-absorbable, synthetic absorbable, mixed The surgeons themselves should be the synthetic, or biological? decision-makers, not the manufacturers!

41 奇美醫院婦產部婦女泌尿科吳銘斌醫師 Thank you!