Long-term patency of vascular grafts of the Ra Long-term patency of vascular grafts of the Ra K type with collagen – results after 10 years K type with collagen – results after 10 years

experience experience

MUDr.Robert Vlachovský, doc.MUDr. Zdeněk Gregor, CSc., MUDr.Robert Vlachovský, doc.MUDr. Zdeněk Gregor, CSc., MUDr.Zdeněk Kříž, doc.MUDr.Robert Staffa, Ph.D., MUDr.Zdeněk Kříž, doc.MUDr.Robert Staffa, Ph.D.,

MUDr.Martin DvořákMUDr.Martin Dvořák

II Surgical ClinII Surgical Cliniic, U sv. Anny Teaching Hospitalc, U sv. Anny Teaching HospitalPekařská 53, Brno 656 91, Czech RepublicPekařská 53, Brno 656 91, Czech Republic

X X Slovak congress of vascular surgery with international participation Slovak congress of vascular surgery with international participation April 3-6 2006, Jasná, SlovakiaApril 3-6 2006, Jasná, Slovakia

HistoryHistory1906 – 1906 – autologous vein graft autologous vein graft ((Carrel ndGuthrieCarrel ndGuthrie) ) 1950s – arterial homografts (1950s – arterial homografts (Gross, Hurwith, Bill)Gross, Hurwith, Bill)

1966 – 1966 – venous allotransplant, cryopreservation venous allotransplant, cryopreservation ((Barner,Lavelock a Barner,Lavelock a BishopBishop))

xenogenous biological graftsxenogenous biological grafts▼▼

1952 – 1952 – synthetic materials synthetic materials ((Voorhees,Jaretski,BlakemoreVoorhees,Jaretski,Blakemore))1955 – 1955 – nylon grafts, crimping nylon grafts, crimping ((Edvards,TappEdvards,Tapp))

1956 – 1956 – knitted seamless graft made of Orlon fibreknitted seamless graft made of Orlon fibre1960s – knitted and woven grafts made of polyester1960s – knitted and woven grafts made of polyester

1958 – 1958 – start of manufacture of artificial vascular grafts in start of manufacture of artificial vascular grafts in Czechoslovakia, 1961 first implantation of these grafts Czechoslovakia, 1961 first implantation of these grafts

Ra K (Ra K (knitted vascular graft with collagenknitted vascular graft with collagen))

→→ Ra 1v K – Ra 1v K – vascular graft, straight, crimped, with collagenvascular graft, straight, crimped, with collagen → → Ra bv K – cévní protéza bifurkační, vrapovaná s kolagenemRa bv K – cévní protéza bifurkační, vrapovaná s kolagenem

knitted vascular graft made of biologically inert polyester fibre and knitted vascular graft made of biologically inert polyester fibre and coated on the outer side with a continuous film of chemically coated on the outer side with a continuous film of chemically modified bovine collagen of type Imodified bovine collagen of type IManufacturer: Výzkumný ústav pletařský, a.s., Brno (Metea® Manufacturer: Výzkumný ústav pletařský, a.s., Brno (Metea® Division)Division)

Study - designStudy - designaim: to evaluate objectively the 10 years’ clinical aim: to evaluate objectively the 10 years’ clinical experience with this kind of graft in the aortofemoral area experience with this kind of graft in the aortofemoral area (especially the long-term patency)(especially the long-term patency)

prospective descriptive non-randomized study on 103 prospective descriptive non-randomized study on 103 patients (operated on in the years 1992-1996) in whom an patients (operated on in the years 1992-1996) in whom an aortofemoral bypass was implanted and who met the aortofemoral bypass was implanted and who met the requirements of the methodology of a clinical study requirements of the methodology of a clinical study according to EN 540:1993 and EN 12006-2:1998according to EN 540:1993 and EN 12006-2:1998for each patient, a file - Clinical Research Records – was for each patient, a file - Clinical Research Records – was established in which all data were storedestablished in which all data were stored

the set did not include patients operated on for ruptured the set did not include patients operated on for ruptured AAAAAA

the 30th postoperative day – dividing line between early the 30th postoperative day – dividing line between early and late complications and late complications

infections (both early and late) are classified according to infections (both early and late) are classified according to Szilagyi Szilagyi the state of graft patency was ascertained by objective the state of graft patency was ascertained by objective examination (palpation, Doppler pencil) at regular checkups examination (palpation, Doppler pencil) at regular checkups after 1, 3, 6, 12 months after surgery and then at intervals after 1, 3, 6, 12 months after surgery and then at intervals of 6 to 12 monthsof 6 to 12 months

Patients’ characteristicsPatients’ characteristics

5 women, 98 men5 women, 98 men

Average age is 57,3 Average age is 57,3 years (24-76)years (24-76)

the largest group the largest group consists of patients consists of patients from from 50 to 59 years of 50 to 59 years of ageage

in 69% of pacients in 69% of pacients (71) (71) the main reason the main reason for operation was for operation was claudicationclaudication, in 31% , in 31% critical ischaemia of a critical ischaemia of a limb (limbs)limb (limbs)

1 0

26

3532

9

0

510

15

20

2530

35

40

decades of agenu

mbe

r of

pat

ient

s

20 - 29 years 30 - 39 years40 - 49 years 50 - 59 years60 - 69 years 70 - 79 years

Set of pacients - Set of pacients - characteristicscharacteristics

perioperative mortality perioperative mortality was 3.9% (4 cases of was 3.9% (4 cases of exitus in the early exitus in the early postoperative period – postoperative period – all with more than one all with more than one risk factor, ICHS, 3 x risk factor, ICHS, 3 x IM), altogether 27 IM), altogether 27 patients died during patients died during the follow-up period the follow-up period (26.2%)(26.2%)average time of graft average time of graft patency follow-up was patency follow-up was 62.5 months (ranging 62.5 months (ranging from 2 to 120 months)from 2 to 120 months)

85,4%

10,7%3,9%

aorto-bifemoral graft (88)aorto-femoral graft (11)aorto-biiliac graft (4)

Summary of diagnosesSummary of diagnoses

49,6%

18,6%14,5% 14,5%

5,8%

Leriche syndrome (51)asympt. AAA (18)sympt. AAA (14)sten. or oblit. AIC or AIE (14)aneurysm AIC or AIE (6)

Risc faktorsRisc faktors

63,8%

42,5%

52,5% 53,8%

23,4%

38,3%

14,4%

smoking (66) DM (44)hypertension (54) dyslipoproteinemia (55)obesity (24) ICHS (39)COM (14)

Early complication - overviewEarly complication - overview

typetype Number of surgeries Number of surgeries (%)(%)

Skin infection and Skin infection and subcutaneous infection subcutaneous infection

(Szilagyi I,II)(Szilagyi I,II)

15 (14,6%)15 (14,6%)

Reoperations - otherReoperations - other 13 (12,6%)13 (12,6%)

Reoperations - Reoperations - vascularvascular

2 (1,9%)2 (1,9%)

TrombosisTrombosis 2 (1,9%)2 (1,9%)

EmbolismEmbolism 1 (0,9%)1 (0,9%)

BleedingBleeding 1 (0,9%)1 (0,9%)

AmputationAmputation 2 (1,9%)2 (1,9%)

Late complications - overviewLate complications - overviewtypetype Number of surgeries Number of surgeries

(%)(%)Skin infection and Skin infection and

subcutaneous infection subcutaneous infection (Szilagyi I,II)(Szilagyi I,II)

2 (1,9%)2 (1,9%)

Graft infection (Szilagyi Graft infection (Szilagyi III)III)

3 (2,9%)3 (2,9%)

PseudoaneurysmsPseudoaneurysms 4 (3,9%)4 (3,9%)Reoperations - vascularReoperations - vascular 18 (17,5%)18 (17,5%)

ThrombosisThrombosis 11 (10,7%)11 (10,7%)EmbolismEmbolism 0 (0%)0 (0%)

AmputationAmputation 5 (4,9%)5 (4,9%)

Long-term patencyLong-term patency

cumulative primary and secondary cumulative primary and secondary patency was evaluated after 1, 3, 5 and patency was evaluated after 1, 3, 5 and 10 years – was evaluated using Kaplan-10 years – was evaluated using Kaplan-Meier survival analysis (life table analysis), Meier survival analysis (life table analysis), similarly also cumulative limb-saving was similarly also cumulative limb-saving was evaluatedevaluatedfurther, other factors influencing long-further, other factors influencing long-term patency were evaluated using term patency were evaluated using univariate and multivariate analysis univariate and multivariate analysis (infrainguinal arteries affections, stenosis (infrainguinal arteries affections, stenosis or obliteration of AFP, surgery time, or obliteration of AFP, surgery time, location of distal anastomosis)location of distal anastomosis)

Long-term patencyLong-term patencyPatency curve after 1,3.5 and 10 yeaafter graft implantation

(life table analysis)

89,0%

93,0%

98,0%99,0%

100,0%

85,0%88,0%

96,0%97,0%

75,0%

80,0%

85,0%

90,0%

95,0%

100,0%

0 1 3 5 10

time from surgery (years)

gra

ft p

ate

ncy

(%

)

secondary patency primary patency

Long-term patency after 5 Long-term patency after 5 years years - comparison - comparison

100,0%

90,0%90,0%

86,0%

96,0%

87,5%

94,7%96,5%

87,0%

100,0%

93,0%93,0%95,0%

50%

100%

secondary patency

Littooy F.N., 1993, USA

Hirt S.W., 1991, Germany

Tada Y., 1993, Japan

van der Akken, 1994, theNetherlandsFriedman S.G., 1995, USA

Zannetti S., 1996, USA

de Vries S.O., 1997, TheNetherlandsZukauskas G., 1998, Kuwait

Meister R.H., 1998, Germany

Onohara T., 2000, Japan

Mingoli A., 2001, USA

Prager M., 2001, Austria

Vlachovský R., 2006, CzechRepublic

Long-term patency after Long-term patency after 1010 years years - comparison- comparison

89,0% 90,0%

80,0%

91,0%

96,0%

89,0%

81,8%

50,0%

100,0%

secondary patency

Littooy F.N., 1993, USA

Nevelsteen A., 1991, Belgium

van der Vliet J.A., 1994, theNetherlandsUrayama H., 1998, Japan

de Vries S.O., 1997, theNetherlandsPrager M.R., 2003, Austria

Vlachovský R., 2006, CzechRepublic

Conclusions Conclusions Implantation of an aortofemoral Implantation of an aortofemoral graft is a procedure with graft is a procedure with excelent long-term patencyexcelent long-term patency and limb salvage and limb salvage – kumulative – kumulative limb salvage is 94 % (5 years) limb salvage is 94 % (5 years) and 90 % (10 years) and 90 % (10 years) Cardiac preparation and Cardiac preparation and intensive perioperative intensive perioperative monitoringmonitoring can improve can improve perioperative mortalityperioperative mortalityLifelong follow-upLifelong follow-up is a is a condition for timely detection of condition for timely detection of possile developing complicationspossile developing complicationsaccording to univariate analysis according to univariate analysis ,, affection of arterial bed under affection of arterial bed under ligamentligament („poor run-off“) („poor run-off“) is a is a statistically important factor statistically important factor influencing long-term patency influencing long-term patency Our results are Our results are comparable comparable with those obteind at centers with those obteind at centers abroadabroad and v and v currently we currently we dispose of a high-quality and dispose of a high-quality and economically affordable graft economically affordable graft made by a Czech manufacturermade by a Czech manufacturer..

Thank you for your Thank you for your attention.attention.