Subintimal Angioplasty as a Primary Modality in the Management of Critical Limb Ischemia: Comparison...

Name /enth/11_407 05/27/2004 02:49PM Plate # 0-Composite pg 65 # 1

J ENDOVASC THER2004;11:000–000

Wednesday May 26 2004 07:41 PM • Allen Press • DTPro GALLEY 65 enth 11_407 Mp_65 • File # 07TQ

Q 2004 by the INTERNATIONAL SOCIETY OF ENDOVASCULAR SPECIALISTS Available at www.jevt.org

lVASCULAR FELLOWS AWARD l

Subintimal Angioplasty as a Primary Modalityin the Management of Critical Limb Ischemia:Comparison to Bypass Grafting for Aortoiliacand Femoropopliteal Occlusive Disease

Niamh Hynes, AFRCSI; Yousaf Akhtar, FRCS; Brian Manning, MD, AFRCSI;

Muyiwa Aremu, MSc, FRCSI; Kenneth Oiakhinan, FRCSI;

Donald Courtney, MCh, FRCSI; and

Sherif Sultan, MD, FRCS (Gen/Vasc), EBQS/VASC

Western Vascular Institute, Department of Vascular and Endovascular Surgery,University College Hospital Galway, Newcastle Road, Galway, Ireland

l l

Purpose: To compare the 30-day morbidity, mortality, length of hospital stay, and patencyrates in patients with critically ischemic limbs treated with subintimal angioplasty (SA)versus standard bypass surgery.Method: Between October 2001 and August 2003, 137 patients (74 women; mean age 70years, range 43–92) with critical limb ischemia underwent subintimal angioplasty (n588)or bypass surgery (n549) for superficial femoral artery (SFA) or aortoiliac lesions. All pa-tients had lesions classified as C or D according to the TransAtlantic Inter-Society Consen-sus. Data was retrieved from hospital inpatient inquiry and VascuBase. Parallel group com-parison was used in performing a prospective observational study.Results: Primary technical success was 100% for both SA and bypass grafting. Thirty-daysurvival was 100% in the SFA-SA and aortoiliac bypass groups and 96% and 93%, respec-tively, in the SFA bypass and aortoiliac SA groups. Limb salvage was 97% and 82% in theSFA-SA and SFA bypass groups, respectively; at the aortoiliac levels, the rates were 100%and 86% for SA versus bypass. Subintimal angioplasty significantly reduced hospital stay(p,0.001). Primary patency was not statistically different in the SA versus bypass groups;however, secondary patency was higher in the SFA bypass group.Conclusions: Frequent clinical follow-up and a duplex surveillance program are necessaryto maintain patency in this cohort. Subintimal angioplasty is increasingly replacing bypasssurgery in the management of critical limb ischemia without compromising primary pa-tency, limb salvage, patient survival, or subsequent vascular intervention.

J Endovasc Ther 2004;11:000–000

Key words: critical limb ischemia, subintimal angioplasty, superficial femoral artery, fem-oropopliteal bypass, aortoiliac bypassl l

The annual ISES/International Congress Peripheral Vascular Fellows’ Research Competition held onFebruary 9, 2004, at International Congress XVII on Endovascular Interventions (Scottsdale, Arizona,USA) evaluated participants on both their oral and written presentations. ISES congratulates the 2004winners of the ISES Endovascular Fellows’ Research Award in the categories of Laboratory Scienceand Clinical Research.

Address for correspondence and reprints: Mr. Sherif Sultan, Consultant Vascular & Endovascular Sur-geon, Department of Vascular & Endovascular Surgery, Western Vascular Institute, University CollegeHospital, Galway, Ireland. Fax: 353-9-154-2360; E-mail: [email protected]


SUBINTIMAL ANGIOPLASTY IN CLIHynes et al.



l l

TABLE 1

Patient Demographics

SFA SA(n 5 74)

FP Bypass(n 5 28*)

AortoiliacSA (n 5 14)

AortoiliacBypass (n 5 21)

Totals137

Mean age, yMen/womenDiabeticsSmokersASA IV

7130/4417 (23%)42 (57%)42 (57%)

7312/168 (28%)

21 (75%)18 (64%)

708/61 (7%)

10 (77%)8 (57%)

6313/85 (24%)

19 (90%)4 (19%)

7063/7431 (23%)92 (67%)72 (53%)

Rutherford:

Class 4Class 5Class 6

24 (32%)36 (49%)14 (19%)

8 (29%)14 (50%)6 (21%)

8 (57%)5 (36%)1 (7%)

10 (47%)6 (29%)5 (24%)

50 (36%)61 (45%)26 (19%)

TASC C/D 54%/46% 10%/90% 40%/60% 10%/90% 37%/63%

Runoff:

1 vessel2 vessel3 vessel

38 (51%)26 (35%)10 (14%)

19 (68%)6 (21%)3 (11%)

5 (36%)5 (36%)4 (28%)

6 (29%)9 (42%)6 (29%)

68 (50%)46 (33%)23 (17%)

l lSFA: superficial femoral artery, SA: subintimal angioplasty, FP: femoropopliteal, ABI: an-kle-brachial index, TASC: TransAtlantic Inter-Society Consensus, ASA: American Societyof Anesthesiologists.* Femoropopliteal (above-knee: below-knee)/Femorodistal 5 16 (11:5)/12.

Nearly forty years ago, Dotter and Judkins de-scribed percutaneous transluminal angioplas-ty.1 Since then, it has had an increasingly im-portant role in the treatment of peripheralvascular disease.2,3 Endovascular therapy hasbeen shown to be as effective as reconstruc-tive vascular surgery in salvaging critically is-chemic limbs, as well as having a more fa-vorable survival rate.4 In 1987, Bolia et al.5

accidentally created a subintimal plane whiletreating a 15-cm popliteal occlusion. Sincethen a modification of this technique has al-lowed treatment of long occlusions not ame-nable to percutaneous transluminal angio-plasty and has broadened the indications forendovascular management.6

The aim of this study was to compare the30-day morbidity, mortality, length of hospitalstay, and patency rates in patients with criti-cally ischemic limbs treated with subintimalangioplasty (SA) or standard bypass surgeryfor aortoiliac and femoropopliteal (FP) athero-sclerotic arterial occlusive disease.

METHODS

Between October 2001 and August 2003, 137patients (74 women; mean age 70 years,

range 43–92) were treated for critical limb is-chemia (CLI). Of these CLI patients, 88 under-went subintimal angioplasty (SA) and 49 hadbypass surgery. Data was retrieved from hos-pital inpatient enquiry and VascuBase. Thepatients were followed at regular intervalsduring our surveillance program. A parallelgroup comparison was used in performingthis prospective observational study.

Entry to the study was limited to those pa-tients in whom major amputation wasthought to be inevitable in the absence of sig-nificant hemodynamic improvement. All pa-tients had rest pain, ulcers, or gangrenecaused by peripheral arterial occlusive dis-ease (Rutherford categories 4 to 67), with anankle-brachial index (ABI) ,0.5 or a reducedtoe pressure (,30 to 50 mmHg). The arterialocclusions were .5 cm in length for bothtreatment groups (C or D lesions by theTransAtlantic Inter-Society Consensus [TASC]classification).8 Patient demographics areshown in Table 1.

Initial management was aimed at achievingadequate pain control, eliminating infection,preventing progression of thrombosis, andoptimizing cardiac and respiratory functionwhile the morphology of the disease was es-





tablished. All patients in this study had pre-operative ABI measurement and duplex scanas triage for endovascular management orbypass surgery. Indications for surgical inter-vention were the presence of an echolucentshadow in the femoral artery, as visualized onduplex scan, and the absence of a ‘‘nipple.’’Both these findings render the lesion unsuit-able for subintimal angioplasty. An echolu-cent shadow in the femoral artery indicatesthe presence of thrombus and the associateddanger of distal embolization or re-thrombo-sis. The absence of a nipple (indicating a flushocclusion) makes it difficult to initiate the sub-intimal dissection plane. In addition, if treat-ing a flush occlusion at the origin of the su-perficial femoral artery (SFA), the origin of theprofunda femoral artery may be compro-mised either by dissection or by the subse-quent balloon angioplasty. Patients withecholucent material in the iliac arteries un-derwent magnetic resonance angiography(MRA). All patients were brought to the op-erating theater on an intention-to-treat basis.

Adjuvant pharmacological manipulationwas aimed at reducing failures due to throm-bosis, myointimal hyperplasia, or further pro-gression of atherosclerosis. The reduction ofcardiovascular morbidity and mortality is animportant consideration. All patients in thisseries were treated with aspirin, pravastatin,and cardioselective beta-blocker during andafter treatment. Postoperatively, clopidogrelwas added for 1 year. This ‘magic bullet’ treat-ment strategy has statistically improved theoverall outcome of high-risk patients with pe-ripheral vascular disease.9

A surveillance program was initiated for allpatients in the series. Patients were seenpostoperatively, at 6 weeks, 3 months, 6months, 9 months, and yearly thereafter. Theprogram consisted of measurement of restingand, if possible, postexercise ABIs, as well asduplex scanning of the entire length of thegraft, with calculation of peak systolic veloci-ties and the velocity ratios across all identifiedlesions. This surveillance modality is capableof detecting stenosis ,50%,10,11 allowing ear-ly detection and management of restenosis.A stenosis between 50% and 75% on duplexscan, together with a drop in ABI .0.15 in the

presence of deterioration in clinical status,was taken as an indication for reintervention.

Outcome Measures

Technical success was satisfactory comple-tion of the procedure with restoration of distalflow; perforation was not regarded as a tech-nical failure in subintimal angioplasty. In linewith the TASC document on the managementof peripheral arterial disease,8 a procedurewas defined as successful only if it fulfilledthe criteria of symptomatic relief, hemody-namic success, and patency. Clinical successwas defined as a combination of symptomaticimprovement and objective hemodynamicsuccess (a .0.15 increase in ABI as a stand-alone criterion or 0.10 if combined with symp-tomatic criteria).

Symptomatic improvement required an up-ward shift of at least one category on theRutherford scale7 with the exception of thosewith actual tissue loss (category 5). These pa-tients were required to achieve a level of clau-dication (category 3) in order to be consideredimproved. Relief of rest pain was defined forthe purposes of this study as ‘‘complete reliefof pain without the use of any analgesics.’’Patients with transdermal ulcers were includ-ed, although ischemic cracks between thetoes or on the heel were not used as measur-able endpoints. Total ulcer healing was takenas the primary endpoint, rather than merely atendency to healing or reduction in ulcer size.Only amputations above the level of the midforefoot were counted as major amputations.

A distinction was made between clinicalsuccess, which applied to the entire limb, andpatency, which applied to the revascularizedor bypassed segment only. Primary patencywas defined as uninterrupted patency follow-ing the initial procedure. Assisted primary pa-tency was used to report outcomes after pro-phylactic interventions. Secondary patencywas taken to mean patency following the ini-tial procedure or following a re-interventionto restore patency of an occluded graft or ves-sel. After either a surgical or endovascularprocedure, secondary patency implied theneed for reopening the treated segment by asecond intervention. The primary endpointwas event-free survival. Nonfatal events in-





l l

TABLE 2

Treatment Outcome

SFA/SA(n 5 74)

FP Bypass(n 5 28)

Aortoiliac/SA (n 5 14)


Technical successMean hospital stay, dMean ABI pre/postLimb salvage, %

100%15 (2–97)0.4/0.6

97

100%37 (9–197)0.4/0.6

82

100%15 (2–108)0.4/0.9

100

100%25 (8–54)0.45/0.75

8630-Day survival, %Primary/secondary patencies, %Patients with .1 procedure

10084/9810 (13%)

9668/1002 (11%)

9393/1001 (7%)

10081/952 (9%)

l lSFA: superficial femoral artery, SA: subintimal angioplasty, FP: femoropopliteal, ABI: an-kle-brachial index.

Figure 1l In a 58-year-old man with left leg critical ischemia, the preoperative duplex ultra-sound scan showed a 25-cm occlusion (shown by the arrow in the intraoperative angiogram,A). Postoperative duplex ultrasound showed minimal stenosis in the proximal and mid SFA,but symptomatically the patient had improved from critical ischemia to intermittent claudi-cation. (B) MRA 7 months postoperatively; note the overestimation of the degree of stenosisby MRA.

cluded major amputation, non-healing ische-mic ulcers, ischemic rest pain, myocardial in-farction, and ischemic stroke.

RESULTS

The technical success (Table 2) for both by-pass surgery and SA was 100% (Figs. 1–3).One perforation occurred during SA; this wastreated using 2 uncovered nitinol SMARTstents, and the procedure was completed suc-cessfully. In all, 10 patients had stenting fol-lowing SFA-SA (elastic recoil with pressuredifference, dissection, perforation, or throm-

bosis). Stents were used in the majority (79%)of the aortoiliac SA cases.

Two patients (1 FP bypass and 1 aortoiliacSA) succumbed to MIs in the 30-day postop-erative period. There was no statistically sig-nificant difference in the mortality rates be-tween the groups (p50.3). Other complications(Table 3) included 2 non-fatal perioperative MIsin the SFA-SA group. One patient in the samegroup developed significant atelectasis post-operatively; there were also 3 clinically signif-icant hematomas (requiring transfusion, evac-uation or prolonged hospitalization) in theSFA-SA group.





Figure 2lAn 81-year-old woman with right lower limb critical ischaemia managed by sub-intimal angioplasty. Completion angiography showed 2 areas of stenosis resistant to balloondilation. Intraoperative measurement of the pressure gradient across the stenosis showed adrop in pressure .20 mmHg, indicating a high risk of restenosis. (A) An Intercoil stent wasdeployed across the proximal lesion (upper arrow) in the hope that the increase in inflowmight reduce the pressure drop across the distal lesion. However, this was not the case, soa second coil (lower arrow) was deployed distally. (B) The MRA 9 months later showed apatent vessel with a smooth outline due to remodeling (arrows point to stent positions).Incidentally, this patient had a contralateral occlusion, but as she had symptoms of claudi-cation only, it was managed conservatively.

In the FP bypass group, 1 patient developedan infected pseudoaneurysm and went on tohave an above-knee amputation. One patienthad an AV fistula that was successfully ligat-ed. One patient in the aortoiliac SA group hada hematoma that required a blood transfu-sion. In the aortoiliac bypass group, 1 patientdeveloped pneumonia postoperatively; 1 pa-tient developed congestive heart failure; 1 pa-tient had an infected graft, which was excised,and another patient developed a seromaabove the graft.

There was a significant difference in themean length of hospital stay among the 4treatment groups even after adjustment forpotential risk factors (diabetes, smoking, ASAgrade). The mean length of stay for the FPbypass group was significantly higher than inthe SFA-SA group (p,0.001). In the aortoiliacgroups, the lengths of stay for the SA groupwas significantly lower than for the bypassgroup (p,0.05).

The mean follow-up was 15.060.6 months.

In the SFA-SA group, 10 (13%) patients had.1 procedure (Table 2): 7 had repeat angio-plasties (1 had a subsequent FP bypass) while3 patients had FP bypass without attemptedangioplasty due to the presence of echolucentmaterial in the SFA. In the FP bypass group,1 patient had ligation of a pseudoaneurysmand another had a jump graft (FP to posteriortibial), giving a re-intervention rate of 11%.One (7%) patient in the aortoiliac-SA grouphad a repeat angioplasty. In the aortoiliac by-pass group, 1 patient underwent excision ofan infected graft and another patient had agroin hematoma evacuated (9% re-interven-tion rate). The difference in re-interventionrates among the 4 subgroups was not statis-tically significant (p50.72)

Cumulative patency was assessed usinglife-table analysis (Table 4, Fig. 4). There wasno significant difference between the patencyrates of the SA versus bypass groups(p.0.05). There was no statistical significancein the odds of achieving primary patency





Figure 3lThree-month postoperative MRA in a56-year-old woman with left critical lower limb is-chaemia due to an 8-cm left common iliac occlu-sion, which was managed by subintimal angio-plasty and implantation of a 1036-cm SMARTstent. Note the drop of signal across the stent inthe MRA. The patient remains hemodynamicallyand symptomatically patent.

l l

TABLE 3

Complications

SFA SA(n 5 74)

FP Bypass(n 5 28*)


AortoiliacBypass (n 5 21) Total

SystemicCardiac:

MI fatal/nonfatalCHF

0/20

1/00

1/00

0/01

2/21

Pulmonary:

AtelectasisPneumonia

10

01

11

Graft

Graft infectionPseudoaneurysmAV fistula

11

1 111

Wound

HematomaSeroma

3 11

41

l lSFA: superficial femoral artery, SA: subintimal angioplasty, FP: femoropopliteal, MI: myo-cardial infarction, CHF: congestive heart failure, AV: arteriovenous.

across the 4 treatment groups while control-ling for all other risk factors (age, male sex,diabetes mellitus, smoking, TASC category,Rutherford classification). The only variablethat significantly affected the odds of primarypatency was the runoff status (p50.026).

DISCUSSION

Both Wolf et al.12 and Holme and colleagues13

have previously reported comparable out-comes in terms of amputation free survivalfor patients with critical limb ischemia (CLI)when prospectively randomized to either en-dovascular or open surgical management.However, they did not differentiate betweenpatients with aortoiliac and infrainguinal dis-ease, supporting our findings that the level ofarterial occlusion does not influence the clin-ical outcome.

Subintimal angioplasty attempts to over-come the problems of intraluminal angioplas-ty by creating a new lumen. Although initiallydescribed by the Leicester group5 for femo-ropopliteal and crural lesions, this techniquehas been extended to include iliac occlusions.We successfully used SA for both femoropop-liteal and iliac occlusions based on a defini-tion of SA as endovascular management of





l l

TABLE 4

Patency rates

SFA SA(n 5 74)

FP Bypass(n 5 28)



PrimaryAssisted primaryCumulative primarySecondarySymptomaticHemodynamic

84%98%95%98%95%98%

68%100%68%

100%82%64%

93%100%93%

100%93%93%

81%100%81%95%81%81%

l lSFA: superficial femoral artery, SA: subintimal angioplasty, FP: femoropopliteal.

Figure 4lPatency curves for (A) SFA-SA and FPbypass (broken line indicates standard error.10%)and (B) aortoiliac SA versus bypass.

arterial occlusive lesions .5 cm in length. SAis undoubtedly operator-dependent. Althoughthe present series at University College Hos-pital Galway reported results of 88 patients,the principal operator had experience withperforming .400 cases in another institu-tion.3

Reports in the literature seem to suggest

that failure to re-enter the vessel true lumendistal to the occlusion is the most frequentlyencountered technical problem. However,from our own series, the most common causeof failure was thrombosis. This was treated byon-table thrombolysis with tissue plasmino-gen activator and aspiration using a 5-F VanAndel catheter.

The Leicester group14 reported a 90% tech-nical success rate for SFA subintimal angio-plasty in a series of patients with a mean 15-cm occlusion length. The major morbidity/mortality rate was 2.5%. However, Bolia etal.,5 Molloy et al.,6 and Lipsitz et al.15 did notselect their patients using duplex ultrasoundto exclude patients with echolucent shadowsin the target artery. We had a technical suc-cess rate of 100% in a series of patients witha mean occlusion length of 18 cm. Our majormorbidity/mortality rate was 4%, despite ourcurrent practice of avoiding digital subtrac-tion angiography as a primary investigatingtool and relying more on noninvasive meth-ods of duplex angiography and MRA.

Technical success rates of 76% to 80% havebeen reported in some studies of femoropop-liteal lesions.5,14 Of these technical successes,up to 84% show clinical improvement at 6months.10 In our study, the technical successrate was 100%, with a 1-month cumulative pa-tency of 95.5%. The Leicester series6 of 200consecutive femoropopliteal occlusionsquotes hemodynamic and symptomatic 1-year patency of 71% and 73%, respectively.Our cumulative 1-year patency rate was95.5%, which supports our opinion that astrict duplex ultrasound protocol is necessary





to ensure that good technical success is fol-lowed by high patency rates. Although paten-cy rates do not appear to be influenced bysymptoms or level of disease, in our series itwas significantly affected by runoff status. Pa-tients with 3-vessel runoff did much betterthan those patients who had only 1 patentdistal vessel. Patency can, however, be un-derestimated due to the rigorous reportingcriteria of the Society for Vascular Surgery.7

In regards to workload, the Leicester group6

showed that 42.3% of patients with CLI couldbe treated with angioplasty alone, while a fur-ther 6.3% were treated with a combination ofbypass and angioplasty. In our study, 87% ofpatients were treated with SA alone, and only5.4% of these required subsequent surgery. Inno case was subsequent bypass surgerymore distal than would have been requiredbefore the attempt at subintimal angioplasty.

Lipsitz et al.15 reported 2 patients who un-derwent subintimal angioplasty after a failedbypass. Both were performed for a threatenedlimb, were technically successful, and re-mained patent at 8 and 26 months, respec-tively. Although this is a very attractive poten-tial application of SA in that it can avoid thetechnical difficulties associated with re-oper-ative bypass surgery, no patient in our bypassgroup required SA.

Our treatment objectives were limb salvageand relief of the symptoms of CLI using thesafest and most minimally invasive approach.Our 1-year limb salvage rate was 97% in theangioplasty group compared to 82% in thebypass group, which compares with the 1-year limb salvage rate of 88% reported by theLeicester group.6

Blair et al.16 compared angioplasty and sur-gery for limb-threatening ischemia in a ret-rospective, nonrandomized trial. The angio-plasty group showed an initial success rate of72% but with a high subsequent failure rate,such that at 2 years the patency was 18%.This contrasts with the surgery group, whichhad a 2-year patency rate of 68% for femo-ropopliteal bypass. However, their limb sal-vage rates were 78% in the angioplasty groupand 90% femoropopliteal bypass. The limbsalvage rate in the angioplasty group wasachieved by secondary procedures in 59% ofpatients, including surgical bypass in 16 pa-

tients. Only 35% of limbs were salvaged by asingle angioplasty compared with 64% oflimbs salvaged by a single bypass graft. Thisstudy was published 14 years ago. In light ofnew advances in endovascular technique,combined with improvements in anesthesia,these figures are now outdated, as the pre-sent study illustrates. The technical successrate was 100% in the SFA-SA group, with a 2-year patency rate of 92.7% (SE 4.91%). In thefemoropopliteal bypass group the 2-year pa-tency rate was 68.4% (SE 17.1%) with an ini-tial success rate of 100%. Limb salvage was97% in the SA group and 82% in the bypassgroup; 87% had a single angioplasty and 89%had a single bypass graft.

In a series of 71 limbs with atheroscleroticSFA occlusion, Gordon et al.17 used balloondilation, stent deployment, and thrombolysis(27%) in the management of periproceduralthrombosis. The 1 and 3-year patency rateswere 55% and 30%, respectively, leading theauthor to conclude that ‘‘angioplasty andstenting yielded higher patency rates thanhistorical controls.’’ This series, and otherslike it,18 did not contain a control group thatcould be used to compare clinical outcomesbetween angioplasty alone and with stenting.A trial of 32 patients with femoropopliteal oc-clusions randomized to angioplasty alone orin combination with a Strecker stent failed todemonstrate an improvement in clinical or ra-diological patency associated with stent de-ployment.19 However, this study was under-powered. The investigation did suggest thatstent placement in the SFA was associatedwith an increased rate of restenosis, whichlimited the efficacy of the technique.

Gray et al.20 also reported a high incidenceof stent-induced restenosis. They calculatedthat the median time to restenosis or occlu-sion following stent placement in the SFA was6 months. All the SFA stents deployed in ourseries have remained patent at a mean fol-low-up of 862.7 months. At present, the ma-jor limitation to primary stenting followingSFA angioplasty is the occurrence of myoin-timal hyperplasia causing arterial restenosisand stent failure. The high incidence of stentfailure has led several authors to recommendlimited use of primary stenting.21,22 Our indi-cations for stenting are limited to manage-





ment of elastic recoil, dissection, perforationand thrombosis.3

Studies on the prognosis of patients withCLI gave an overall mortality rate of 19.1% at12 months, similar to the prognosis of myo-cardial infarction and stroke. In view of this,endovascular management is a preferablemode of intervention in patients with signifi-cant comorbid disease, as they usually havepoor survival due to advancing age and car-diovascular and cerebrovascular disease.Overall survival rate in our group was 91% at1 year. It is therefore prudent to prioritizeshort-term symptom relief over long-term pa-tency.23

Many CLI patients have multilevel diseaseand may require concomitant lower level re-vascularization. Combined endovascular/sur-gical procedures have had success in this re-gard. Iliac artery angioplasty to improveinflow for an infrainguinal arterial reconstruc-tion has been shown to be successful in care-fully selected patients.24,25 In our series, 3 pa-tients in the aortoiliac angioplasty group hadconcomitant distal revascularization. One pa-tient had CIA angioplasty and stenting with afemorofemoral crossover graft; another had aright CIA angioplasty and stenting with a rightto left femorofemoral crossover graft andright femoropopliteal above-knee bypassgraft. The third patient had a right CIA angio-plasty and stent and a right femoropoplitealbelow-knee bypass graft. All have remainedpatent (average length of primary patency 14months) at the time of this study.

Long-term results of iliac angioplasty liveup to the promise of durable effectiveness,suggested by early reports, and have been re-confirmed by several large series.26–30 Tech-nical success rates for balloon angioplasty ofiliac stenoses, based on intention-to-treat, ex-ceed 95% and yield 1 to 3-year primary paten-cy rates of ;80% and 65%, respectively, withassisted primary rates of about 75% and 80%.With the availability of stents after 1989,many studies reported increased 1 and 3-yearprimary patency rates with stenting on both aselective and routine basis.31–38 At present, nodata exists to support the practice of routineprimary stenting for iliac lesions. Their use-fulness in the management of elastic recoil,

dissection, and thrombosis are, however, welldocumented.39

Reported patency rates for angioplasty ofiliac occlusions are, as expected, less thanthose for stenoses.40,41 Technical success and1 and 3-year primary patency are both im-proved with stenting. One and 3-year patencyrates of ;75% and 65%, respectively, havebeen reported with appropriate patient selec-tion.42 Stenting of recurrent iliac lesions wasseen to enhance patency by 5% to 10% atboth time intervals. The TASC Working Grouprecommends that TASC D lesions (.10 cm)be treated by surgery. The management ofTASC C lesions still remains controversial, buttechnical developments in endovascular man-agement have led to reasonable successrates. All the patients in our series had TASCC or D lesions, with a mean occlusion lengthof 9 cm. Lesions ,5 cm (TASC A or B) aretreated by intraluminal balloon angioplasty,as recommended by the TASC WorkingGroup. The TASC document, however, makesno allowances for the use of subintimal an-gioplasty. In lesions .5 cm, we assume thatthey are treated by subintimal angioplasty.Most studies of endovascular management ofaortoiliac atherosclerotic disease refer toTASC A or B lesions. Little is reported on theapplication of the subintimal technique to iliacangioplasty. In our study, technical successwas 100%, with cumulative and assisted pri-mary patency rates of 93% and 100%, respec-tively. When the results of aortoiliac SA areweighed against aortobifemoral bypass, per-haps the most successful of all open interven-tions, they compare favorably. There was nosignificant difference between patency ratesin the aortoiliac SA and bypass groups, evenwhen controlling for ASA grade, presentingsymptoms, and lesion TASC grade.

The TASC document concludes that pa-tients with diffuse arterial disease are besttreated by surgery where possible.8 However,surgery is physiologically challenging for thisfrail group of patients. Subintimal angioplastyenables treatment of more complex diseasepatterns than conventional intraluminal dila-tion, broadening the indications for endovas-cular treatment. Computer modeling hasshown that angioplasty for ischemic rest paincan increase quality adjusted life expectancy





and decrease lifetime treatment cost com-pared with surgery.43

Total in hospital costs per admission for pe-ripheral revascularization procedures arehighly variable and are significantly increasedby procedure-related complications, increas-ing age, female sex, therapy for critical limbischemia, and the presence of coronary arterydisease. In this study, however, the length ofhospital stay was significantly reduced in theangioplasty group compared to the bypasspatients, which reflects the reduced anesthe-sia requirements with a minimally invasiveapproach, as well lower complication ratesand less need for intensive care. This has sig-nificant economic implications. Reduced hos-pital stay and shorter operating time enablesa faster turnover of patients, with symptom-atic relief reducing the requirements for on-going tissue viability and nursing care.

In conclusion, SA is increasingly replacingbypass surgery in the management of criticallimb ischemia without compromising primarypatency, limb salvage, patient survival, orsubsequent vascular intervention. The aim oftreatment should be limb salvage and symp-tom relief rather than long-term patency, withminimal invasiveness and economic costs.We recommend that subintimal angioplasty isfirst-line management in limb-threatening is-chemia. It seems appropriate that vascularsurgeons skilled in both endovascular andopen surgical techniques should make thetherapeutic decisions.

Acknowledgments: The authors would like to acknowl-edge the work of the Vascular Laboratory technologistsSandra Nicholls, Chief Technologist; Cathy McInerney,Senior Technologist; Lisa Donlon; and Anne Fahy for theircooperation and expertise. We also wish to acknowledgethe Radiology Department in U.C.H.G. and express ourgratitude to Dr. John Newell, Department of Statistics,National University of Ireland.

REFERENCES

1. Dotter CT, Judkins MP. Transluminal treatmentof arteriosclerotic obstruction. Description of anew technic and a preliminary report of its ap-plication. Circulation. 1964;30:654–670.

2. Nasr MK, McCarthy RJ, Hardman J, et al. Theincreasing role of percutaneous transluminalangioplasty in the primary management of crit-

ical limb ischaemia. Eur J Vasc Endovasc Surg.2002;23:398–403.

3. Sultan S, Colgen MP, Madhaven P, et al. In: YaoJST, Pearce WH, eds. Advances in VascularSurgery. Vol. 25, Chicago: Precept Press; 2001:265–276.

4. Motarjeme A. PTA and thrombolysis in leg sal-vage. J Endovasc Surg. 1994;1:81–87.

5. Bolia A, Miles KA, Brennan J, et al. Percuta-neous transluminal angioplasty of occlusionsof the femoral and popliteal arteries by subin-timal dissection. Cardiovasc Intervent Radiol.1990;13:357–363.

6. Molloy KJ, Nasim A, London NJM, et al. Per-cutaneous transluminal angioplasty in thetreatment of critical limb ischemia. J EndovascTher. 2003;10:298–303.

7. Rutherford RB, Baker JD, Ernst C, et al. Rec-ommended standards for reports dealing withlower extremity ischemia: revised version. JVasc Surg. 1997;26:517–538.

8. TASC Working Group. Management of periph-eral arterial disease. Outcome assessmentmethodology in peripheral arterial disease.TransAtlantic Inter-Society Consensus (TASC).Eur J Vasc Endovasc Surg. 2000;19(Suppl. A):S30–S39.

9. Oaikhinan K, Akhtar Y, Hynes N, et al. A com-parative parallel group study with and withoutthe ‘magic bullet’ in the perioperative and post-operative period for abdominal aortic aneu-rysm surgery and femoropopliteal segment re-vascularization. Does the ‘magic bullet’improve the 30-day morbidity and mortalityoutcome? Ir J Med Sci. 2003;172:S2–27.

10. Londrey GL, Hodgson KJ, Spadone DP, et al.Initial experience with color-flow duplex scan-ning of infrainguinal bypass grafts. J VascSurg. 1990;12:284–290.

11. Vroegindeweij D, Tielbeek AV, Buth J, et al. Pat-terns of recurrent disease after recanalizationof femoropopliteal artery occlusions. Cardio-vasc Intervent Radiol. 1997;20:257–262.

12. Wolf GL, Wilson SE, Cross AP. Percutaneoustransluminal angioplasty versus open surgeryfor peripheral arteriosclerosis. Report of a pro-spective randomized trial in a selected groupof patients. J Vasc Surg. 1989;9:1–9.

13. Holm J, Arfvidsson B, Jivegard L, et al. Chroniclower limb ischaemia. A prospective random-ised controlled study comparing the 1-year re-sults of vascular surgery and percutaneoustransluminal angioplasty (PTA). Eur J VascSurg. 1991;5:517–522.

14. London NJ, Srinivasan R, Naylor AR, et al.Subintimal angioplasty of femoropopliteal ar-





tery occlusions: the long-term results. Eur JVasc Surg. 1994;8:148–155.

15. Lipsitz EC, Ohki T, Veith FJ, et al. Does subin-timal angioplasty have a role in the treatmentof severe lower extremity ischaemia? J VascSurg. 2003;37:386–391.

16. Blair JM, Gewertz BL, Moosa H, et al. Percu-taneous transluminal angioplasty versus sur-gery for limb-threatening ischemia. J VascSurg. 1989;9:698–703.

17. Gordon IL, Conroy RM, Arefi M, et al. Three-year outcome of endovascular treatment of su-perficial femoral artery occlusion. Arch Surg.2001;136:221–228.

18. Cheng SW, Ting AC, Wong J. Endovascularstenting of superficial femoral artery stenosisand occlusions: results and risk factor analysis.Cardiovasc Surg. 2001;9:133–140.

19. Zdanowski Z, Albrechtsson U, Lundin A, et al.Percutaneous transluminal angioplasty with orwithout stenting for femoropopliteal occlu-sions? A randomized controlled study. Int An-giol. 1999;18:251–255.

20. Gray BH, Sullivan TM, Childs MB, et al. Highincidence of restenosis/occlusion of stents inthe percutaneous treatment of long-segmentsuperficial femoral artery disease after subop-timal angioplasty. J Vasc Surg. 1997;25:74–83.

21. Gray BH, Olin JW. Limitations of percutaneoustransluminal angioplasty with stenting for fem-oropopliteal arterial occlusive disease. SeminVasc Surg. 1997;10:8–16.

22. Lampmann LE. Stenting in the femoral super-ficial artery: an overview. Eur J Radiol. 1999;29:276–279.

23. Bertele V, Roncaglioni MC, Pangrazzi J, et al.Clinical outcome and its predictors in 1560 pa-tients with critical limb ischaemia. Chronic Crit-ical Leg Ischaemia Group. Eur J Vasc EndovascSurg. 1999;18:401–410.

24. Marin ML, Veith FJ, Sanchez LA, et al. Endo-vascular aortoiliac grafts in combination withstandard infrainguinal arterial bypasses in themanagement of limb-threatening ischemia:preliminary report. J Vasc Surg. 1995;22:316–325.

25. Timaran CH, Ohki T, Gargiulo NJ, et al. Iliac ar-tery stenting in patients with poor distal runoff:influence of concomitant infrainguinal arterialreconstruction. J Vasc Surg. 2003;38:479–485.

26. Harris RW, Dulawa LB, Andros G, et al. Percu-taneous transluminal angioplasty of the lowerextremities by the vascular surgeon. Ann VascSurg. 1991;5:345–353.

27. Tegtmeyer CJ, Hartwell GD, Selby JB, et al. Re-sults and complications of angioplasty in aor-

toiliac disease. Circulation. 1991;83(2 Suppl):I53–I60.

28. Jeans WD, Armstrong S, Cole SEA, et al. Fateof patients undergoing transluminal angioplas-ty for lower-limb ischemia. Radiology. 1990;177:559–564.

29. Johnston KW. Iliac arteries: reanalysis of re-sults of balloon angioplasty. Radiology. 1993;186:207–212.

30. Jorgensen B, Skovgaard N, Norgard J, et al.Percutaneous transluminal angioplasty in 226iliac artery stenoses: role of the superficialfemoral artery for clinical success. Vasa. 1992;21:382–386.

31. Gupta AK, Ravimandalam K, Rao VR, et al. To-tal occlusion of iliac arteries: results of balloonangioplasty. Cardiovasc Intervent Radiol. 1993;16:165–177.

32. Bosch JL, Hunink MG. Meta-analysis of the re-sults of percutaneous transluminal angioplastyand stent placement for aortoiliac occlusivedisease. Radiology 1997;204:87–96.

33. Murphy TP, Webb MS, Lambiase RE, et al. Per-cutaneous revascularization of complex iliacartery stenoses and occlusions with the use ofWallstents: three-year experience. J Vasc IntervRadiol. 1996;7:21–27.

34. Laborde JC, Palmaz JC, Rivera FJ, et al. Influ-ence of anatomic distribution of atherosclero-sis on the outcome of revascularization with il-iac stent placement. J Vasc Interv Radiol. 1995;6:513–521.

35. Brewster DC. Clinical and anatomical consid-erations for surgery in aortoiliac disease andresults of surgical treatment. Circulation. 1991;83(2 Suppl):I42–I52.

36. Tetteroo E, van der Graaf Y, Bosch JL, et al.Randomised comparison of primary stentplacement versus primary angioplasty fol-lowed by selective stent placement in patientswith iliac-artery occlusive disease. Dutch IliacStent Trial Study Group. Lancet. 1998;351:1153–1159.

37. Palmaz JC, Laborde JC, Rivera FJ, et al. Stent-ing of iliac arteries with the Palmaz stent: ex-perience from a multicenter trial. CardiovascIntervent Radiol. 1992;15:291–297.

38. Strecker EP, Hagen B, Liermann D, et al. Iliacand femoropopliteal vascular occlusive dis-ease treated with flexible tantalum stents.Cardiovasc Intervent Radiol. 1993;16:158–164.

39. Cambria RA, Farooq MM, Mewissen MW, et al.Endovascular therapy of iliac arteries: routineapplication of intraluminal stents does not im-





prove clinical patency. Ann Vasc Surg. 1999;13:599–605.

40. Blum U, Gabelmann A, Redecker M, et al. Per-cutaneous recanalization of iliac artery occlu-sions: results of a prospective study. Radiolo-gy. 1993;189:536–540.

41. Rutherford RB, Durham J. Percutaneous bal-loon angioplasty for arteriosclerosis obliterans:long-term results. In: Yao JST, Pearce WH, eds.

Techniques in Vascular Surgery. Philadelphia:WB Saunders; 1992:329–345.

42. Wolf YG, Schatz RA, Knowles HJ, et al. Initialexperience with the Palmaz stent for aortoil-iac stenoses. Ann Vasc Surg. 1993;7:254–261.

43. Hunink MG, Wong JB, Donaldson MC, et al. Re-vascularization for femoropopliteal disease. Adecision and cost-effectiveness analysis.JAMA. 1995;274:165–171.

Subintimal Angioplasty as a Primary Modality in the Management of Critical Limb Ischemia: Comparison...

Documents

Transcript of Subintimal Angioplasty as a Primary Modality in the Management of Critical Limb Ischemia: Comparison...