L uso di protesi biologiche nelle rivascolarizzazioni poplitee

Transcription

1 L uso di protesi biologiche nelle rivascolarizzazioni poplitee V. Dorrucci Ospedale dell Angelo - Venice - ITALY Department of Cardio-Thoracic- Vascular Surgery Unit of Vascular and Endovascular Surgery

2 Summary of venous bypass literature for below knee bypass large Meta analysis with numerous publications Dalmann & Taylor (Ann Vasc Surg 1990) review of publications from Ziegler (Ann Vasc Surg 2011) review of publications from only below knee, crural and pedal included Technique: in-situ / reversed / mixed or technique not specified 11 relevant publications from 2010 to 2015 only publications with >100 patients included Total patients (min max ) 7% above knee, 27% below knee, 52% crural, 14% pedal Technique: in-situ / reversed / mixed or technique not specified Slide and data courtesy: Wolfgang Meichelböck and Kim Houlind ESVB 2015

3 Summary of venous bypass literature for below knee bypass Implantation site: Below-knee fem-pop and crural vast majority 90% Pedal - some, above knee fem-pop very few No trend/significant difference in patency or limb salvage rates regarding the technique used Very few publications beyond 5 years results (lots of patients die within 5 years) Patency rates %* 1 year 3 years 5 years Primary patency 75% (58-86%) 69% (39-83%) 60% (32-71%) Secondary patency 85% (70-96%) 78% (70-87%) 73% (60-83%) Limb salvage 89% (79-94%) 82% (72-87%) 81% (66-89%) *non-weighted average of all publications (range) Excellent long term patency and limb salvage rates make the venous bypass still the first choice for revascularization in critical limb ischemia (CLI) Slide and data courtesy: Wolfgang Meichelböck and Kim Houlind ESVB 2015

4 Biosynthetic prosthesis to resemble autologous vein Haemocompatible Smooth, non-thrombogenic flow surface Good long-term patency, even with poor runoff Biocompatible Rapidly integrated into host tissue Good resistance to infection Rapid haemostasis after puncturing Non-porous No seeping or seroma formation No needle-hole bleeding No tissue ingrowth Good compliance Little intimal hyperplasia Can be anastomosed directly to peripheral blood vessels No need for cuffs, patches or jump grafts

5 Biosynthetic prosthesis: Omniflow II The Omniflow II prosthesis is a biosynthetic device formed from stabilised sheep collagen with an integral polyester mesh. It is produced by inserting polyester mesh-covered mandrels beneath the cutaneous muscle of adult sheep for a period of weeks. The collagen-encapsulated tubes are harvested and stabilised using glutaraldehyde. From : Bio Nova International Pty Ltd, Melbourne, Australia

6 Rapid integration into host tissue From : Bio Nova International Pty Ltd, Melbourne, Australia

7 Technical details Handles like a saphenous vein Thin and supple Cut, trimmed and shaped with ease Easy to suture Excellent suture retention Minimal suture-hole bleeding with standard sutures Can be anastomosed directly to peripheral vessels No need for cuffs, patches or jump grafts

8 Omniflow Femoro-popliteal bypass - early results (Koch et al. University Graz Austria ) 274 patients, mean 70 y (41-88y) CLI (III/VI) 274 (100%) Patency / limb salvage at 3 years (above 3 y SE >5%) Patency Ruf-Off Above knee Below knee Crural (2y) Results: Mortality 3 (1.1%) 6 (2.1%) wound infections No (0%) grafts infection 3 aneurysmal dilatations Primary Good (2-3 vessels) 62% 55% Primary Bad (0-1, ips) 44% 35% 29% Secondary Good (2-3 vessels) 76% 59% Secondary Bad (0-1, ips) 65% 46% 36% Limb salvage 81% 71% 60% 111 (41%) no antiplatelet or OAC medication at all!! Conclusion: The Omniflow prosthesis in general was found both to perform adequately as a vascular prosthesis when autogenous conduits were unavailable Koch G, et al. Analysis of 274 Omniflow Vascular Prostheses implanted over an eight-year period. Aust N Z J Surg. 1997;67(9):637-9.

9 Omniflow Femoro-popliteal bypass - recent results The Omniflow II Biograft Long term experience with implantation in femoropopliteal position Dünschede F. Stabrauskaite J. Doemland M. Vahl C.-F. Dorweiler B. (University of Mainz, Germany ) 2006 July 2013 (Follow up until Aug 2014 median 39 months) 131 patients, med. 69 y (44-89y), 43 (33%) female 141 Omniflow operations (8 bi lateral + 2 second implants) Claudication (IIb) 58 (42%) CLI (III/VI) 60 (43%) III 20 (14%) / IV 40 (29%) ALI 17 (12%) Popliteal aneurysm 4 (3%) position n % above knee 32 23% below knee % Ø 5 mm 26 19% Ø 6 mm % Duenschede F. Gefässchirurgie :

10 Omniflow Femoro-popliteal bypass - recent results The Omniflow II Biograft Long term experience with implantation in femoropopliteal position Dünschede F. Stabrauskaite J. Doemland M. Vahl C.-F. Dorweiler B. (University of Mainz, Germany ) Results: 4 (3 %) 30 d mortality 16 (11,5%) early occlusions 11 successful thrombectomies 4 new vein bypass (contralat. vein) + 1 new Onmiflow bypass 1 (0.7%) % infection rate 3 (2.1%) aneurysms/degenerations all repaired/replaced without any further consequences 5 Major Amputations (5 years) 2 in stage IV (CLI) 3 with acute thrombosed popliteal aneurysm and distal occlusion 5 years results Patency % Primary 37% Primary assisted 58% Secondary 69% Limb Salvage 95% Duenschede F. Gefässchirurgie :

11 Ospedale dell Angelo Venice/Mestre - ITALY Department of Cardio-Thoracic- Vascular Surgery Unit of Vascular and Endovascular Surgery The Hospital of Angelo was opened in Jan Hub of Venice Province and a regional (Veneto) tertiary referral center Serving a resident population of Angelo Hospital s vascular unit : 9 full-time vascular surgeons - 24/7 elective & emergency vascular service 14 beds vascular surgical ward + 4 beds for Week-surgery/Day Surgery 550 arterial vasc. procedures / year (broad spectrum of vascular disease)

12 Omniflow II infrainguinal graft bypass revascularization: a preliminary analysis of 79 patients From 2002 to 2016: 748 infrainguinal bypass performed in our institution. We have identified 79 patients undergone peripheral vascular reconstruction with Omniflow II. Method and Data analysis: Retrospective All medical records have been reviewed. Graft Patency: Patency has been counted with the last information of patency in the medical records. Limb Salvage: Patients without recent information on patency have been called (Dec-2016) and interviewed by telephone regarding major amputation (patency was not counted, as the bypass could also be occluded)

13 Risk factors Total n (%) Redo = Omniflow as sec. procedúre Omniflow prim. procedure Total 79 (100%) 28 (35%) 51 (65%) Gender Omniflow II infrainguinal graft bypass revascularization: a preliminary analysis of 79 patients Patient data / Risk factors: 42 (64.6%) 23 (35.4%) 19 (67.9%) 9 (32.1%) 33 (64.7%) 18 (35.3%) p-value Diabetic (Insulin Dependent) 39 (49%) 8 (29%) 31 (61%) Cholesterol (Genetic / Familial hypercholesterolemia) Age (years) 71.7 ± 9.6 y Range: years (8%) 3 (11%) 3 (6%) Ischemic Heart Disease 32 (41%) 13 (46%) 19 (37%) Hypertension (all causes) 42 (53%) 17 (61%) 25 (49%) Smoker (active) 40 (50%) 15 (54%) 25 (49%) On Dialysis 6 (8%) 0 (0%) 6 (11%) Neoplasia (Cancer) 17 (22%) 4 (14%) 13 (26%) 0.391

14 Omniflow II infrainguinal graft bypass revascularization: a preliminary analysis of 79 patients Classification of Peripheral Arterial Disease: Fontaine's Stages Group (n) II B III IV Popliteal Aneurysm (PA) Acute Limb Ischemia (ALI) p-value Total (79) 11 (14%) 28 (35%) 29 (37%) 6 (8%) 5 (6%) Redo (28) 3 (11%) 11 (39%) 11 (39%) 0 (0%) 3 (11%) First choice (51) 8 (16%) 17 (33%) 18 (35%) 6 (12%) 2 (4%) CLI (72%)

15 Omniflow II infrainguinal graft bypass revascularization: a preliminary analysis of 79 patients Risk factors Total n (%) Redo = Omniflow as sec. procedúre Omniflow prim. procedure Total 79 (100%) 28 (35%) 51 (65%) External Iliac popliteal BK 2 (3%) 2 (7%) 0 (0%) Fem-Pop AK (PI) 7 (9%) 2 (7%) 5 (10%) Fem-Pop BK (PIII) 53 (67%) 18 (64%) 35 (69%) Fem-TTP 14 (18%) 3 (11%) 11 (22%) Fem-Crural 3 (4%) 3 (11%) 0 (0%) p-value Composite bypass with vein 14 (18%) 4 (14%) 10 (20%) Adjuvant AV-Fistula 7 (9%) 3 (11%) 4 (8%) Adjuvant TEA/Patch 14 (18%) 5 (18%) 9 (18%) 1.000

16 Omniflow II infrainguinal graft bypass revascularization: a preliminary analysis of 79 patients Postoperative Medication n (%) On Statin Therapy 65 (100%) On Antiplatelet Therapy 65 (100%) On additional Oral Anticoagulant Therapy 8 (12.3%) In our institution we prefer to put all patients under sodic heparin infusion for 1-2 days during the immediate post-operative time just to guarantee a fuctionally stabilization of the graft. All patients are discharged with own admission therapy. In that case all of them had an antiplatelet + statin. We prescribe OAT for bypass patency purpose only if the patient has a bypass thrombosis after discharge despite the antiplatelet therapy.

17 Omniflow II infrainguinal graft bypass revascularization: a preliminary analysis of 79 patients Results Total n (%) Redo = Omniflow as sec. procedúre Omniflow prim. procedure p-value Bypass thrombosis within 30 days 4 (5%) 1 (4%) 3 (6%) Mortality/ Perioperative Death (30 days) 4 (5%) 2 (7%) 2 (7%) Major amputation (30 days) 3 (4%) 1 (4%) 3 (6%) Omniflow Infection day 421 redo with vein Omniflow Aneurysm formation (postop) at 4.5 years, explant, redo 1 (1%) 1 (4%) 0 (0%) (1%) 1 (4%) 0 (0%) - - Follow-up Time Mean ± SD Range All 79 patients 3.2 ± 2.7 y 3 d 11.2 years

18 Primary patency rate / 5 years 5y 55.9% / SE 8.1% Time 0 m 36 m 60 m n Pat:

19 Primary assisted patency rate / 5 years 5y 66.2% / SE 8.2% Time 0 m 36 m 60 m n Pat:

20 Secondary patency rate / 5 years 5y 69.7% / SE 8.0% Time 0 m 36 m 60 m n Pat:

21 Limb Salvage rate / 5 years 5y 74.3% / SE 7.5% 3 of 11 major amputations during the first 30 days Time 0 m 36 m 60 m n Pat:

22 Survival / free from death after OP 5y 53.3% / SE 8.4% 21 patients died after OP SURVIVAL: Mean: 6.8 years Median: 7.4 years Remember 50% of patients with CLI die within 5 years Time 0 m 3y 5y 7 y 9 y n Pat:

23 Summary: 3 & 5 year Kaplan Meier analysis Omniflow II - 79 patients Parameter 3-years (SE) 5 years % (SE) Primary patency rate 67.1 % (6.4 %) 55.9 % (8.1 %) Primary assisted patency rate 78.3 % (5.5 %) 66.2 % (8.2 %) Secondary patency rate 81.8 % (5.3 %) 69.7 % (8.0 %) Limb Salvage rate 85.6 % (4.8 %) 74.3 % (7.5 %) Very high patency rates (consequent statins + antiplatelet /OAC medication?) Very high limb salvage rate - almost in the range of vein Survival Mean (95% CI) Median (95% CI) Survival (free from death) 6.8 years ( y) 7.4 years ( y)

24 Comparison of Omniflow results vs vein and own data Koch (1997) Below-knee Omniflow Venice (2016) Omniflow Dünschede (2015) fem-pop ak/bk Omniflow Debus (2013) vein Debus (2013) PTFE & Dacron Venice (2016) Omniflow vein bypass literature ( ) n 107 (bk) Time 3 years 3 years 5 years 5 years 5 years 5 years 5 years Primary pat. 35% - 55% 67% 37% 61% 34% 56% 60% (32-71%) Prim. Ass. Pat % 59% 66% Secondary pat. 46%-59% 82% 69% 64% 37% 70% 73% (60-83%) www Limb salvage 71% 86% 95% 73% (64-81%) 57% (51-62%) 74% 81% (66-89%) Early occlusions (8%) 16 (12%) (8%) Graft aneurysm 3 (1.1%) 1 (1.2%) 3 (2.1%) (1.2%) Graft infection 0 (0%) 1 (1.2%) 1 (0.7%) (1.2%)

25 Omniflow II infrainguinal graft bypass revascularization: a preliminary analysis of 79 patients. Conclusion For us the Omniflow II prosthesis serves as an excellent option which showed very good long term results. The Omniflow II is our preferred bypass material in many cases (critical patient, infection site, redo surgery) Vein still remains the preferred bypass material but for the Biosynthetic Prosthesis we need more trials (national data base)