Femorodistal ePTFE-bypass grafting using femorocrural patch prosthesis (FCPP). Results of a prospective clinical study
Summary
Femorodistal bypass using exclusively PTFE is known to have a poor prognosis, mostly because of the development of myointimal hyperplasia (MIH). Several vein patch techniques are established but the role of hemodynamics within the anastomotic site has only been explained insufficiently and is hardly considered clinically. In a prospective study, between 6/1992 and 7/1998 129 patients (89 m/40 f, mean age 65.2 ± 10.0 years) with critical limb ischemia and no usable saphenous vein were included to undergo femorodistal ePTFE bypass grafting with a new, hemodynamically optimized distal end-to-side anastomosis. Patients were followed at 6-month intervals with clinical investigation and color-coded Doppler sonography. Primary and secondary graft patency (PPR, SPR), limb salvage, and patient survival were calculated according to Kaplan-Meier. With a median follow-up of 45 (range 6 to 72) months, PPR and SPR at 1, 3 and 5 years were 63.0, 35.7 and 27.6 % and 74.5, 44.8 %, and 37.6 %, respectively. Limb salvage at 1, 3 and 5 years was 86.4 %, 78.7 % und 73.2 %. There was no perioperative mortality. Graft infection occurred in 7 patients (5.2 %). ePTFE bypass grafting represents a valuable option for infragenicular and crural reconstruction in the absence of autologous vein. The new anastomotic design was feasible and represents another adjunct to possibly improve patency of femorodistal bypass allografts.
Zusammenfassung
Die femoro-distale Rekonstruktion unter ausschließlicher Verwendung von ePTFE gilt als problematisch und ist prinzipiell durch die Entwicklung der myointimalen Hyperplasie (MIH) gefährdet. Verschiedene Venenpatchplastiken sind bisher verwendet worden. Die Rolle der Hämodynamik im Anastomosenbereich ist bis dato nur unzureichend geklärt und wird klinisch kaum berücksichtigt. In einer prospektiven Beobachtungsstudie wurden von 6/1992 bis 7/1998 insgesamt 129 Patienten (89 m/40 w, mittleres Alter 65,2 ± 10,0 Jahre) in den klinischen Stadien III/IV (Fontaine) der peripheren arteriellen Verschlußkrankheit durch femoro-distale ePTFE-Bypassrekonstruktion mit einer hämodynamisch optimierten distalen termino-lateralen Anastomosenform behandelt. Es wurden nur Patienten eingeschlossen, bei denen keine autologe V. saphena magna oder parva zur Verfügung stand. Kontrolluntersuchungen erfolgten klinisch und mittels farbcodierter Dopplersonographie nach 1 und 6 Monaten und danach jährlich. Die primären und sekundären Bypassoffenheitsraten sowie die kumulativen Wahrscheinlichkeiten für Extremitätenerhalt und Überleben der Patienten wurden nach Kaplan-Meier berechnet. Bei einem Follow-up von 6 bis 72 (median 45) Monaten betrugen die primären und sekundären 1-, 3- und 5-Jahres-Offenheitsraten jeweils 63,0/74,5 %, 35,7/44,8 % und 27,6/37,6 %. Der Erhalt der Extremität nach 1, 3 und 5 Jahren gelang in jeweils 86,4 %, 78,7 % und 73,2 %. Perioperativ trat kein Todesfall ein. Eine Protheseninfektion wurde bei 7 Patienten (5,2 %) beobachtet. Die ausschließliche Verwendung von ePTFE stellt bei nicht verfügbarer autologer Vene eine wertvolle Option der femoro-distalen infragenualen Revaskularisation mittels Bypass dar. Die Verwendung einer hämodynamisch optimalen Anastomosenform erwies sich als klinisch realisierbar und führt potentiell zu einer Verbesserung der Offenheitsraten femoro-infragenualer und -kruraler allogener Bypassrekonstruktionen.
Key words
Femoroinfragenicular bypass - Critical limb ischemia - ePTFE grafts - Anastomotic technique - Patency rates - Limb salvage
Schlüsselwörter
Femoro-distaler Bypass - ePTFE - Anastomosentechnik - Ergebnisse - Offenheitsraten
Literatur
1
Ascer E, Collier P, Gupta S K, Veith F J.
Reoperation for polytetraethylene bypass failure: the importance of distal outflow site and operative technique in determining outcome.
J Vasc Surg.
1987;
5
298-310
2
Ascer E, Gennaro M, Pollina R M, Ivanov M, Yorkovich W R, Ivanov M, Lorensen E.
Complementary distal arteriovenous fistula and deep vein interposition: A five-year experience with a new technique to improve infrapopliteal prosthetic bypass patency.
J Vasc Surg.
1996;
24
134-143
3
Bassiouny H S, White S, Glagov S, Choi E, Giddens D P, Zarins C K.
Anastomotic intimal hyperplasia: mechanical injury or flow induced.
J Vasc Surg.
1992;
15
708-717
4
Bastounis E, Georgopoulos S, Maltezos C, Alexiou D, Chiotopoulos D, Bramis J.
PTFE-vein composite grafts for critical limb ischemia: a valuable alternative to all-autogenous infrageniculate reconstructions.
Eur J Vasc Endovasc Surg.
1999;
18
127-132
5
Brennan J A, Enzler M A, Da Silva A, How T V, Harris P L.
New graft design to inhibit myointimal hyperplasia in small vessel anastomoses.
Br J Surg.
1996;
83
1383-1384
6
Calligaro K D, Syrek J R, Dougherty M J, Rua I, Raviola C A, DeLaurentis D A.
Use of arm and lesser saphenous vein compared with prosthetic grafts for infrapopliteal arterial bypass: Are they worth the effort.
J Vasc Surg.
1997;
26
919-927
7
Chang B B, Darling R C, Bock D E M, Shah D M, Leather R P.
The use of spliced vein bypasses for infrainguinal arterial reconstruction.
J Vasc Surg.
1995;
21
403-412
8
Chevru A, Moore W.
An overview of intimal hyperplasia.
Surg Gynecol Obstet.
1990;
171
433-442
9
Christenson J T, Broomé A, Norgren L, Eklöf B.
Revascularization of popliteal and below-knee arteries with polytetrafluoroethylene.
Surgery.
1985;
97
141-149
10
Da Silva A F, Carpenter T, How T V, Harris P L.
Stable vortices within vein cuffs inhibit anastomotic myointimal hyperplasia.
Eur J Vasc Endovasc Surg.
1997;
14
157-163
11
Dardik H.
The second decade of experience with the umbilical vein graft for lower-limb revascularization.
Cardiovasc Surg.
1995;
3
265-269
12
Donaldson M C, Whittemore A D, Mannick J A.
Further experience with all-autogenous tissue policy for infrainguinal reconstruction.
J Vasc Surg.
1993;
18
41-48
13
Faries P L, Arora S, Pomposelli F B, Pulling M C, Smakowski P, Rohan D I, Gibbons G W, Akbari C M, Campbell D R, LoGerfo F W.
The use of arm vein in lower-extremity revascularization: Results of 520 procedures performed in eight years.
J Vasc Surg.
2000;
31
50-59
14
Hamsho A, Nott D, Harris P L.
Prospective randomized trial of distal arteriovenous fistula as an adjunct to femoro-infrapoplitael PTFE bypass.
Eur J Vasc Endovasc Surg.
1999;
17
197-201
15
Jakobsen H L, Baekgaard N, Christoffersen J K.
Below-knee popliteal and distal bypass with PTFE and vein cuff.
Eur J Vasc Endovasc Surg.
1998;
15
327-330
16
Kansal N, Pappas P J, Gwertzman G A, Silva M B, Jamil Z, Lee B C, Chan F, Padberg F T, Hobson R W.
Patency and limb salvage for polytetrafluoroethylene bypasses with vein interposition cuffs.
Ann Vasc Surg.
1999;
13
386-392
17
Kaplan E L, Meier P.
Nonparametric estimation from incomplete observations.
J Am Stat Assoc.
1958;
53
457-481
18
Kissin M, Kansal N, Pappas P J, DeFouw D O, Durán W N, Hobson R W.
Vein interposition cuffs decrease the intimal hyperplastic response of polytetrafluoroethylene bypass grafts.
J Vasc Surg.
2000;
31
69-83
19
Londrey G L, Ramsay D E, Hodgson K J, Barkmeier L D, Sumner D S.
Infrapopliteal bypass for severe ischemia: comparison of autogenous vein, composite, and prosthetic grafts.
J Vasc Surg.
1991;
13
631-636
20
Martin R S, Edwards W H, Mulherin J L, Edwards W H, Jenkins J M, Hoff S J.
Cryopreserved saphenous vein allografts for below-knee lower extremity revascularization.
Ann Surg.
1994;
219
664-670
21
Miller J H, Foreman R K, Ferguson L, Faris L.
Interposition vein cuff for anastomoses of prostheses to small artery.
Aust NZ J Surg.
1984;
54
283-285
22
Neville R F, Attinger C, Sidawy A N.
Prosthetic bypass with a distal vein patch for limb salvage.
Am J Surg.
1997;
174
173-176
23
Parsons R E, Suggs W D, Veith F J, Sanchez L A, Lyon R T, Marin M L, Goldsmith J, Faries P L, Wengerter K R, Schwartz M L.
Polytetrafluoroethylene bypasses to infrapopliteal arteries without cuffs or patches: A better option than amputation in patients without autologous vein.
J Vasc Surg.
1996;
23
247-356
24
Rückert R I, Krüger U, Heise M, Müller P, Scholz H.
Experimentelle Optimierung der Hämodynamik distaler termino-lateraler Bypass-Anastomosen, Entwicklung einer neuen Anastomosenform.
Langenbecks Archiv Chir.
1996;
(Suppl I)
215-219
25
Rückert R I, Settmacher U, Krüger U, Scholz H.
Femorodistal PTFE bypass grafting for severe ischemia: Results of a prospective clinical study using a new distal anastomosis with optimized hemodynamics.
Eur J Vasc Endovasc Surg.
2000;
20
51-56
26
Sayers R D, Raptis S, Berce M, Miller J H.
Long-term results of femorotibial bypass with vein or polytetrafluoroethylene.
Br J Surg.
1998;
85
934-938
27 Scholz H, Settmacher U, Krüger U, Zanow J. Arterienchirurgie. In: Schulte KL, Bollinger A (Hrsg): Kappert - Lehrbuch und Atlas der Angiologie. X. Aufl, Huber, Bern 1998; 407-448
28
Schweiger H, Klein P, Lang W.
Tibial bypass grafting for limb salvage with ringed polytetrafluoroethylene prostheses: Results of primary and secondary procedures.
J Vasc Surg.
1993;
18
867-874
29
Shah D M, Darling C, Chang B B, Fitzgerald K M, Paty P S, Leather R P.
Long-term results of in situ saphenous vein bypass.
Ann Surg.
1995;
222
438-448
30
Siegman F A.
Use of a venous cuff for graft anastomosis.
Surg Gynecol Obstet.
1979;
148
930
31
Sladen J G, Reid J D, Maxwell T M, Downs A R.
Superficial femoral vein: a useful autogenous harvest site.
J Vasc Surg .
1994;
20
947-952
32
Sottiurai V S.
Biogenesis and etiology of distal anastomotic intimal hyperplasia.
Int Angiol.
1990;
9
59-69
33
Stonebridge P A, Pescott R J, Ruckley C V.
Randomized trial comparing infrainguinal polytetrafluoroethylene bypass grafting with and without vein interposition cuff at the distal anastomosis.
J Vasc Surg.
1997;
26
543-550
34
Taylor L M, Edwards J M, Porter J M.
Present status of reversed vein bypass grafting: five year results of a modern series.
J Vasc Surg.
1990;
11
193-206
35
Taylor R S, Loh A, McFarland R J, Cox M I, Chester J F.
Improved technique for polytetrafluoroethylene bypass grafting: long-term results using anastomotic vein patches.
Br J Surg.
1992;
79
348-354
36
Tyrrell M R, Wolfe J HN.
New prosthetic venous collar anastomotic technique. Combining the best of other procedures.
Br J Surg.
1991;
78
1016
37
Veith F J, Gupta S K, Ascer E, White-Flores S, Samson R H, Scher L A, Towne J B, Bernhard V M, Bonier P, Flinn W R, Astelford P, Yao J ST, Bergan J J.
Six-year prospective multicenter randomized comparison of autologous saphenous vein and expanded polytetrafluoroethylene grafts in infragenual arterial reconstructions.
J Vasc Surg.
1986;
3
104-114
38
Whittemore A D, Kent K C, Donaldson M C, Couch N P, Mannick J A.
What is the proper role of polytetrafluoroethylene grafts in infrainguinal reconstruction.
J Vasc Surg.
1989;
10
299-305
Dr. R. I. Rückert
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