248

Laser Angioplasty of Peripheral Arterial Occlusive Disease P. E. Huppert', H. Seboldt', S. H. Duda' , H. Se tter', C. D. Claussen', and H.-E. Hoff meister' 1

Dep ar tm ent of Diagncstic Radiology

z Dep artme nt of Cardlovasc ular Surgery Eberhard -Karl s-Unive rsität Tübingen . Tüblngen. Germany

Ta evalutate the impact of laser abla tion of arterioscler otic mater ial on the lang-term resuits of tra nsluminal a ngioplast y, 103 patients were treat ed by laser-assisted reca naliza tion of per iphera l ar terial occlusion and followed-up for 6 an d 12 months . Two pulsed laser syste ms (308 nm-excimer laser and 504 nm-dyc laser ) were tes ted . Laser energy was transmitted via wire-guided 4.5-, 7· a nd 9-Fre nch multifiber catheters. Sta nd-alone laser angioplasty was possible in 22 % of the pat ien ts. es pecially in the poplitea l and the lower-limb arteries. Compar ed to the resul ts of balloon dilatatic n in the litera tu re, the clinical success rat e at 6 a nd 12 mont hs after the treat men t wa s better in occlusions with a length betw een 6 and 10 cm. however no impro vement was see n in eithe r shorter or Ionger occlusion. Due to the limited size of percutaneously a pplicable cat heters. laser tr eatm ent and pretreatment see med to be of most benefit in distal femoro popliteal arteries an d in lower-limb arteries. Cllnical im provement after revascularization depen ds on a sufflcient run -offi n brau eh ing vessels distal to the reca nalized artery segment. Key words Arteries. extr emities - Arteries, laser angioplasty - Arte ries. tra nsluminal angioplasty - Lasers

Introducti on The therap y of chro nic ar terial occlusions has to tak e int o account the progression of und erlying arterio sc1eroti c diseas e. In relation to the type of lesion , percutaneous revascularization methods, such as ballon dilata tion , at herectomy and laser angioplast y are used to avoid or postp one surgical treat ment. Laser ene rgy can he ut ilized to support the passage of guide wire -resis tant occlusion s or to debulk arte riosc1e rotic material for restori ng arterial perfu sion . The rat e of successful primary recanalization in long arte rial occlusion could not be improved by th e use of continuous -wave lasers (6 ,9) .

EtTective ah lation of arteriosclerot ic material has heen shown for pulsed laser syste ms such as th e excimer las er (3, 10) and th e dye iaser (12. 14). The safety of both laser Thorac. eardiovase. Surgeon 39 ( 991 ) (Supplement) 248-25 1 © Georg Thieme Verlag Stuttgart - New York

Las erangiopl asti e der peripheren arteriell en Versc hlus skr ankheit Ziel der Unte rs uchung wa r es zu prü fen , inwieweit die Ablatio n von arteriosklerotischem Verschluß mat eria l mittels Laser en ergie das klinische La ngzeitresultat der transluminalen Angtoplastie beeinflußt. Hierzu wurden 103 periphere arterielle Gefäßverschlüsse laserassistiert reka nalisier t und die Patienten üb er 6 und 12 Monate naehbeobachtet. Es wurden zwei gepu lste Lasersysteme (308 nm Exclmer-Lase r und 506 nm Fa rbstoffLaser ) getestet. Die Laser ener gie wurde durch führungsdra htgesteuerte 4.5-. 7-, und v-Fren ch-Multffaserkathcter übert ragen. Eine Laserang ioplastie ohne zusätzliche Ballondilat ation war bei 22 % der Patienten ausreichend , insbesondere bei Vorliegen poplitealer und kru rale r Verschlüsse . Verglichen mit Langzeitergebnissen der Ballona ngiop lastie aus der Literatur war die klinische Erfolgsrate 6 bzv..'. 12 Mona te nach Laserangioplastie nur bei Patienten mit Versc hlüsse n einer Lä nge zwischen 6 und 1Dem verbesse rt. Bei kürz eren und auch bei länger en Gefäßversc hlüssen zeigte n sich dagegen keine besser en Result ate. Wegen der limitiert en Größe per kuta n einführb ar er Laserkathete r ist eine vollstä ndige oder überwiegen de Beseitigung des Verschluß mate rials nur in distalen femoropoplitealen und in kru ralen Arte rien er reichba r . Die klinische Besse rung nach Reka nalisation wir d se hr sta rk vom peripheren Abst rom über ein suffizientes Verteilerseg me nt bestimmt.

systems in peripherai angioplasty has also heen de monstrated in clinical practice (1, 5, 11, 15; 13). The pur pose of our study in 103 patients was to evaluate the impact of pulsed laser debulking on the long-term su ccess ra te in percutan eously treated arterial occlusions . Material and Methuds From March 1989 to October 1990, 110 patient s were recru ited for laser a ngioplas ty (LA) of tota l peripher al arte rial ocdusions . The patient population cons isted of 79 men and 3 1 wom en rage range: 41 - 87 years : mea n. 66 .5 years}. Arterial c cclusive disease was present at Fontain e stage IIb in 65 pat ients. at stage 11I in 25 pati ents a nd at stago IV in 20 pat ients. Diabetes was present in 28 patients and 60 patients were past smokers. Ta ble 1 summa rizes the len gths a nd locations ofthe occlusions tre ated . The length was below Sem in 65 patie nts. more tha n Se m in 45 patien ts and more than 1Dem in 10 pat ients. The treatment was performed und er loeal a nesthesia via an ipsilaterally pla ced introducer shea th (6-F to 9-F). After prim ar y recanalization by the use of stee ra ble guide wires a nd the roadma p

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Summary

Las er Aflgioplasty o[Peripheral Arterial Occlus ive Disease Locationandlenght of occlusions recruited forlaserangioplasty.

Location

n

Length(em) 2-5 6-10

> 10

mean

Ihac Femcropopliteal

17 78 15 110

14 37 14 65

1 9 0 10

3.4 7.6 3.6 6.8

Lower-lirnb Total

2 32 1 35

tomatology of at least one Fontaine stage combined with an lncrease oft he ankle-branchial Index ofa t least 0.2. Patients treated by the excimer laser had a c1 inical follow-up of 12 mc nths and patients treated by the dye laser of 6 months. A reocclusion was s uspected if symptoms recu rr ed and the ankle-branchial index decreased 0.2 or more , compared to the two-day posttreatmen t status. In all pat len ts with suspected reoccluslon . the diagnosis was confirmed or exclu ded by angiography.

Table2 Technical success rate and cne-year clinical success rate ot excirner laser-assisted angioplasty (LA) in relation to the lenght of arterial occlusions recanalized.

Results

Lenght ot occlusion (em)

n

Technical success m of recana lization

Clinical sussess at 1 yr after LA

The tec hnical success of re canalization w as ac hieved in

2- 5 6-10 >10 Total

50 23 7 80

47/ 50 (94%) 20/23 (87%) 5/ 7 (71%) 72/ 80 (90%)

34/46 (74%) 15/22 (68%) 2/ 7 (29%) 51175 (68%)

46 22 7 75

n = number of pat ients recruitedtorLA m = numberof patients followed-upto one yearatter LA.

Table 3 Technical and ctinical outcome in 110 patientsrecruitedfor excimer laser angioplasty (ELA) and dye taser angioplasty (DLA).

Patients recruited Successfu l guidewire passage Successfu! recanalization Initial clinical success Clin icaf longtermsuccess

ELA n

DLA n

total n

80 75 72 67 68%(51175-1 12 months

30 28 26 26 73%(22/30) 6 months

110 103(94%) 98 (89%1 93(84%1

. 5 pati ents lost to Iollow-up after ELA.

tech nique . mu ltifiber laser catheters ' wer e gently advaneed over the wire aeross the occlusion simultaneously emitti ng pulsed laser energy. Cath et cr ad vancement was slowed down if an increas ed resistance was noticed. Laser catheter passages were repeated tw o to six tim es un til the recanalized vessel diameter matched the siz e of the laser catheter or no furhter luminal wide rring was obtained. 9-F laser catheters were used in the illac. 7-F in the femoropopliteal and 4.5·F catheters in the lower-Iimb arteri es . Ba1l00n dilatation was performed subsquently if a stenosis of more than 30 % per sisted after the laser procedure. Guide wire passage succeede d in 103 of 110 patients (94 %) as a pr erequisite for the application oflas er energy. Two types ofpuls ed laser systems w ere tested. Seventy-flve patients were treated by the use of a 308· nm excime r las er " working wit h a pulse -wid th of 60 nsec. an energy per pulse of 10- 20 mJ and a rep etition rate of 20- 40 Hz. Twenty-eight patients were treated with a 504 ·nm flas hlarnp-ex cited dye las er ' working with a pulse-width of 1.4 usec , an energy per pulse of 40- 110 mJ and a repe tition rate of

10Hz. During the procedure. 5000 to 10000 units of heparin we re administered and intermittent flush ing via the introducer sheath was performed using heparinized saline. Heparinization w as continued by i.v. a pplicalton of 1000 units per hour for 24 hours Iocclu sio n length less than 5 cml or 48 hours (occlusio n length more than 5 cm ). The technical success of recanalization was defined as pat ency of the treated vesel se gme nt without a residual stenosis of 50 %or more. Clinical success was defined as an improvemcnt in symp -

89 % (98 of 110 pr ocedures), followed by a clinieal sho rt term sueeess in 84 % (93 patients). In 7 pati ents guid e wire passage failed a nd in 5 pati ents poplitea l and lower -limb a rt eries reoeclud ed des pite the laser and balloon proeed ure. In 5 patien ts wi th femorop oplit eal oc clus ions , re canaIi zed teehnieally sueeessfully. clinieal improvem ent did not a ppea r beeause of a ma rked redu eed dista l run-off. In the excim er las er group, 62 pati ent s were trea te d clinieally suecessfully a nd followed -up to 12 month s (3 teeh nieal a nd 5 elinieal failures, 5 patie nts lost to follow-u p). Wirhin this per iod , 11 reocclus ions occ urred giving a cliniea l sueeess rate of 68 % (51/75 patients followe d-u p}, Related to the nu mber of initial sueeessfullyt reated patients , the one -year sueeess rate was 82 % (51162). Th e ra te of reocclusion dep ended on the length of lesion s (Tabl e 2). Re occlu s ions occurred more freque ntly if the le si on s were

langer th an 10 em and resid ual stenoses ofmo re th an 30 % or large disseetions per si sted after re canali zation . Fo ur pat ie nts with re occlu si on s we re diab eti c.

In the dye laser gro up, 26 pati ent s were treated elinieally sueeessfully and had a follow-up of 6 months . In this patien t population 4 reo cclu si on s occ urred. giving a success

rat e of 73 % (22/3 0 pati ent sl . Relat ed to the numb er of initia lly sueeessfully treated patients, the suceess rate is 85 % (22/26 ). The teehni eal a nd clinieal outeom e ofthe pati ent s in the ex cimer las e r and dye laser gro ups a re summar ized in

Tabl e 3. Fa ilures of the las er proce dur e were ca use d by inc om -

plete laser eatheter passages du e to an insufficient "pus ha bility" of the multifib er ea the ters in 5 pati ents (2 exeime r laser -treated , 3 dye laser-trea ted) a nd in 8 patie nts by a total vess el reobstru etion afte r withd rawal oft he laser eat he te r (5 in exeime r laser and 3 in dye laser a ngioplasty). ln 8 ofthese patients, pat eney was obta ined by ba lloon dilata tion usin g low-profile balloon eat heters (ultrathin ba lloon dilatati on catheterl", In 5 pati ents reean alizat ion failed , thu s mak ing bypa ss surgery necessa ry, In 23 of 103 pati ents (22%) ad ditional balloon dilatation w as not necessa ry afte r total or partial recan aIization

by laser debulking (Fig. 1). The mea n grade of residual steno ses w as 4 9 %in the excime r las er group an d 48% in th e

dye laser gro up. Balloon dilatation was ma nd atory in iliae a rte ries , inevitable in 85 % of th e femoropopliteal a rte ri es , but neeessary on ly in 50 % ofthe lower -lirnb lesions (Fig. 2). The spee d of laser eatheter advaneement duri ng reeanali zati on was 18-24 mm per minute using th e pulsed dye lase r and on1y 2-S mm pe r minute using tbe e xci me r

I

2

3

Cera m optec Corporation , Bann , Germany Techno las Corporarinn. Grä fe1fing , Germany Cande la Laser Corpo rati on , Wayland, MA. USA

, Bost on Seientific Corporation . Wate rt own. MA. USA

249

laser , The more powe rful a blatio n of the dye laser ea used le w-grade disse etions in 41 % of the procedu res , visible a ng iographieally. These disseetions did not obsruet vessel lum en .

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Table1

Thorac . cardiovasc. Surgeofl 40 (1992)

Thorac. cardiovasc. Surgeon 39 (1991)

P. E.lIuppert.11.S eboldt. S. JI. Duda.H. Se iler. C. D. Cloussen. and II. -E. lIoffmeist er

Due to the over the wire access, peforation and dissection oft he laser eat hete r could be avoided in all pati ent s.ln 8 patient s embolization oceurred, eaused by the balloon angioplasty in 7 patients and by the laser recanalization in one patient. In 5 of these pat ients loeal thro mbolysis suceeeded, 3 pati ent s ha d to be operated.

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Fig. 1 Stand-alcne excimerlaser angioplasty in the distal femoropopliteal artery. 62-year-old womansufferingfrom intermittent claudicatton with awalking distance of 100m. a) Sem-leng occlusion of the right distal femoropophteal artery b}residualstenoses between50%and70%aftertwo passagesof a 9-Flaser catheter c) after 4 pessages ot the laser catheter, 30- 50 %residualstenoses d}final result after6 passages of the lasercatheter with aresidual stenosisbelow 30%

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Fig. 2 Dye laser-assisted angioplastyof a long lower-Iimb artery occluston 68-year-old man with pedal ulcera dueto ehreniearterial occlustve disease. a)6cm-longoccluslon of the hbuer artery andstenoses of thetibioftbutar trunk. The anterior andcostertor tibial arteriesare occluded completely b) Aftertwo passages of a 4.5·Flaser catheter a subtotal recanalizatlon is obtan ec. snort residual stenoses between 30 %and50 %remained. c)Anglegram afterSmrn- balloon dilatation showed normal diameter ot the fibular arteryandthe tibiotibulartrunk

Tran sluminal balloon dilatation is widely accepted as the techn ique of choice for pereutaneous treatment of arteriosclerotic stenosis in the lower extremity. However , longterm resu lts after the recanalization of femoropopliteal oeclusions are less promising. Pateney rates between 45 % an d 55 % at one yea r afte r balloon dilatation have been re ported for representative studies including large num bers of pati ents (2, 7, 8). The clinical sueeess rate in our pat ient population was 73 % at six mont hs afte r dye laser -assisted a ngioplasty and 68 l Yo at one yea r after excimer laserass isted angio plasty. These results ar e close to the range of success rates after balloon dilatation in stenotic lesions which wer e repor ted in the literatur e as 74 % to 81 % (2, 4, 7. 8). The improvement in the treatment of occlusions is probably due to the deb ulking of arterioscle rotie ma terial, whieh eonverts oeclusion into ste noses prior to dilatation in most of th e pat ien ts. Assess rnent of success rates has to eonsider the length of oeclusions trea ted . In short lesions (2- 5 em) an d in very long oeclusions (more than lOem) ea rly res ults and Iongterm res ults are similar to those after balloon dilatation. In occlusions with a length between 6 an d IOcm , the clinieal sueeess rate at one year after excime r laser angioplastywas 68 %, wh ich mea ns an improve ment in eomparison to the resu lts ofba lloon angioplasty (2, 4, 7, 8). The most frequent angiogra phic finding in patients with reocclusions was an unsatisfaetory angiomor phological result including residual stenosis and disseetion in reea nalize d lesions of mor e tha n 5 em. As expecte d, these are th e same predietors ofreoeclusion as in balloon dilatation (2, 8). The clinieal sueeess ofreea nalization is decisively influenced by th e distai run-off Most benefit results if recanalization is per formed proximally to sufficient branehing vesseI segmen ts. Due to the Iimited size oflase r cathet ers , wh ich can be used percutan eously, desir able LA, without orwith the minimal mechani eal balloon dilatation elTeet to the arterial wall, ean be realized only in dista l femoro poplitea l arte ries and in lower -limb arte ries. Pulsed dye laser energy within the blue-green spectral range shows plaque-selective ablation properties 614), which result in an elTeetive debulking of arteriosclerotie mat erial (12, 14). In our studies, the mean speed of laser catheter adva ncement durin g dye laser -recan alization was 22 mm per minute, which is about 4 to 5 times higher than th e eorres pond ing value determined in excimer laser ang ioplasty. On the other hand, the appli cati on of dye laser energy of more than 70 mJ per pulse was related to an increase d freq ueney of low-grad e dissections. These dissections ar e probably eause d by shoc k-wave elTeets. To redu ce these elTeets, dye laser angioplasty should be started at an energy level of about 70 mJ per pulse. This radiant exposure is above th e ablation threshold for plaque material (14). If a persistent resistanee aga inst the catheter movement indi-

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250

01 Perip heral Arterial Occlu s iv e Dis eu s e

eates an inerea sed tiss ue abl atio n threshold, the en ergy applied should be raised gradually. In conclusion, the follow-up data of ou r pati ents show th at th e debu lking of arte riosclerotie materi al by th e application of pulsed laser ene rgy via multi fiber cat hete rs was better than the clinieal results ofballoon angioplasty only in les ions with a len gth between 6 to 10 em. In shorter, as weil as in lan ger . occlus ions the result s remaine d similar . Laser tr eatment or pr etr eatm en t should be performed pr efera bly in distal fem or opapliteal a rte ries and in lower-limb arteries to inerease the eiTeet of debulking in relation to the eiTeet of meehanieal dilatat ion . Sueeess ful lase r -ass isted reeanalization of femorop opliteal occlusions can pr event or postpo ne bypass surg er y but sho uld be per formed only if at lea st Fontaine stage IIb disease is pr esent. However , recanalization of occlus ions in the lower-limb arteries is indicat ed if a patient suiTers from at least Font ain e stage III diseas e. Refere nces 1

2

3

-I

b

Adler. L.. A. Lituack. W. S. Grundfest. A. 1lickey. 1. Segalowitz, a nd J. S. Forrester: Excimer La ser Ballo on Angioplasty Treatment of Perip her al Vascular Occlusions and Stenoses Iabstr.I Ra diology 169 (1988) 276 Gallino. A.. F. Mahler. P. Probs t. and B. Nachbur. Percuta neous Transluminal Ang ioplasty of the Arte ries ofthe Lower Limbs: A 5· yea r Pollow-up. Circulation 70 (198 4) 619- 623 Grundfest. W. S .. P. Ltmack . J. S. Forrester et ai.: Laser Ablatio n of Huma n Athe rosclerotic Plaque wit hout Adja cen t Tisue Injury. J. Am. Coll. Cardio !. 5 (1985) 929- 933 He toes. H, C.. R. I. White. R. R. Murrau et al.: La ng-ter m Results of Superficial Fem or a l Arte ry Angioplasty . AJ R 146 (1986 ) 102 5- 10 29 Huppe rt. P. E., S. H. Dudc. H. Seboldt, K. R. Karsch. und C. D. Claussen: Periphe re Excimer-Lase rangioplastie. Indikationen. Methode und klinische Ergeb nisse. Dtseh. med. Wseh r. 116 (199 1) 161 -167 Jeans. W D.. P. M urphy, A. O. Huq hes. AI. Herrocks. and R. N. Baird: Rand om ized Tria l of La ser -assisted Passage through

Thorac. cardiovasc. Su rgeon 40 (1992) Occluded Fem oro popliteal Arteries . The Brit. J . Rad iol. 6 3 (l 9901 19-21 t Johnston. W, M. Rae. S. A. Hogg-Johns ton etal.: 5-yea r Results ofa Prosp eetive Study of Per cuta neous Tra nslumlnal Angio plasty. Ann. Surg. 206 (1987 l 403-413 8 Krep el. V. M.. G. J. van Andel. W F. M. van Erp. and B. J. Breslau: Pereuta neous Transluminal Angioplasty of the Fem oro po pliteal Arte ry : Initial and Long-term Results. Rad iology 165 (l985 ) 325-328 9 l.ammer, 1., E. Pilger, F. Kamel et al.: Laser Angioplasty. Resu lts of a Prospeetive . Multicen tre Study at Scyea r Polleev-u p. Radiology 178 (1991) 335-337 10 Litvack. F., L. Doyle, W. S. Grundfest et ai.: In vive Excime r La ser Ablation: Acute a nd Chron ic EfTects on Can ine Aorta . Circulation 74 Isuppl 2) (1986) 360 11 Litva ck. F.. ~V. S. Grundfest. L.Adler et al.: Percutaneous Excimer Lase r and Exeimer Laser-assisted Angiop lasty of the Lowe r Extre mities: Results or Initi al Clinica l Tr ia l. Ra dio logy 172 (1989) 33 1-335 12 Murray, A.. R. Bas u. C. wette. and R. F. AI. Wood: Defining Para meters for Per iph er al Laser Ang ioplasty . Eur . J. Vase. Surg. 3 (1989) 31-36 13 Murray, A.. D. C.Mitekelt. M. Gras ty . R. F. ,\-1. Wood. D. H. Edwards. and R. Basu: Periphera l La ser Angioplasty with Pulsed Dye Lase r and Ba ll-tlpped Optiea l Fibr es. The Lan cet 23/30 (1989) 1471- 14 74 H Prince. M. R.. T. F. Deu tsch. A. H. Shapiro et al.: Selecti ve Ablation of Atheromas using a Flas hla mp-exeited Dye Laser at 465 nm. Proe. Natl. Aead. Sei. USA 83 (1986) i064 - 7068 15 S chwarten. D.. and w. B. Cutcliff: Use of Excime r La ser in the Pereuta neous Manageme nt of Peripheral Athe ros clerosis Ia bstr .). lIadiology 165 (198 7) 276

P. E. Huppert Depar tment of Diagnostic Radiology Eberhard-Ka rls-University Tü bingen Hopp e-Seyler -Str . 3 D-7400 Tü bingen Germa ny

251

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Laser Angioplusty

Laser angioplasty of peripheral arterial occlusive disease.

To evaluate the impact of laser ablation of arteriosclerotic material on the long-term results of transluminal angioplasty, 103 patients were treated ...
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