From the New England Society for Vascular Surgery
Infrapopliteal angioplasty for critical limb
ischemia: Relation of TransAtlantic InterSociety
Consensus class to outcome in 176 limbs
Kristina A. Giles, MD, Frank B. Pomposelli, MD, Allen D. Hamdan, MD, Seth B. Blattman, MD,
Haig Panossian, BS, and Marc L. Schermerhorn, MD, Boston, Mass
Objective: Recent data suggest that percutaneous transluminal angioplasty (PTA) may be appropriate primary therapy for
critical limb ischemia (CLI). However, little data are available regarding infrapopliteal angioplasty outcomes based on
TransAtlantic InterSociety Consensus (TASC) classification. We report our experience with infrapopliteal angioplasty
stratified by TASC lesion classification.
Methods: From February 2004 to March 2007, 176 consecutive limbs (163 patients) underwent infrapopliteal angioplasty
for CLI. Stents were placed for lesions refractory to PTA or flow-limiting dissections. Patients were stratified by TASC
classification and suitability for bypass grafting. Primary outcome was freedom from restenosis, reintervention, or
amputation. Primary patency, freedom from secondary restenosis, limb salvage, reintervention by repeat angioplasty or
bypass, and survival were determined.
Results: Median age was 73 years (range, 39-94 years). Technical success was 93%. Average follow-up was 10 months
(range, 1-41 months). At 1 and 2 years, freedom from restenosis, reintervention, or amputation was 39% and 35%,
conventional primary patency was 53% and 51%, and freedom from secondary restenosis and reintervention were 63% and
61%, respectively. Limb salvage was 84% at 1, 2, and 3 years. Within 2 years, 15% underwent bypass and 18% underwent
repeat infrapopliteal PTA. Postoperative complications occurred in 9% and intraprocedural complications in 10%. The
30-day mortality was 5% (9 of 181). Overall survival was 81%, 65%, and 54% at 1, 2, and 3 years. TASC D classification
predicted diminished technical success (75% D vs 100% A, B, and C; P < .001), primary restenosis, reintervention, or
amputation (hazard ratio [HR], 3.4; 95% confidence interval [CI], 2.1-5.5, P < .001), primary patency (HR, 2.2; 95%
CI, 1.3-3.9, P < .004), secondary restenosis (HR, 3.2; 95% CI, 1.6-6.4, P ? .001), and limb salvage (HR, 2.6; 95% CI,
1.1-6.3, P < .05). Unsuitability for surgical bypass also predicted restenosis, reintervention, or amputation, secondary
restenosis, need for repeated angioplasty, and inferior primary patency and limb salvage rates.
Conclusion: Infrapopliteal angioplasty is a reasonable primary treatment for CLI patients with TASC A, B, or C lesions.
Restenosis, reintervention, or amputation was higher in patients who were unsuitable candidates for bypass; however, an
attempt at PTA may be indicated as an alternative to primary amputation. Although restenosis, reintervention, or
amputation is high after tibial angioplasty for CLI, excellent limb salvage rates may be obtained with careful follow-up
and reinterventions when necessary, including bypass in 15%. (J Vasc Surg 2008;48:128-36.)
Good technical and clinical results have been obtained
with pedal bypass for the treatment of tibial occlusive
disease causing limb ischemia.1A combination of excellent
durability and low mortality make this procedure an attrac-
tive option for patients with a threatened extremity. How-
ever, significant morbidity can be associated with distal
bypass surgery. A mortality rate approximating 2% is typi-
cally cited, but some studies have found rates as high as 5%
for distal bypass surgery. Patients may lack conduit or
target, be nonambulatory, have a limited life expectancy,
have an extensive soft tissue infection overlying a bypass
target, or infrequently have comorbidities that make them
an unacceptable risk. In these patients, percutaneous trans-
luminal angioplasty (PTA) may constitute a feasible revas-
cularization method rather than primary amputation.
Recently, the Bypass Versus Angioplasty in Severe Isch-
emia of the Leg (BASIL) study suggested that if the anatomy
priate first therapy even if the patient is a good candidate for
bypass. Ideal anatomy was not well defined in BASIL, how-
ever, and outcomes were not stratified by the distal extent of
disease (superficial femoral/popliteal/tibial).7
Outcomes of tibial PTA are difficult to predict from the
existing literature owing to a lack of details regarding
indications for intervention and lesion characteristics.6-17
The TransAtlantic InterSociety Consensus (TASC) criteria
represents a standardized definition for lesion characteris-
tics (Table I).8,9Our objective was to review our results of
infrapopliteal angioplasty stratifying patients by anatomic
characteristics according to the TASC classification.
We performed a retrospective study analyzing periop-
erative and follow-up outcomes of infrapopliteal angio-
plasty for patients with critical limb ischemia. The study
From Beth Israel Deaconess Medical Center.
Competition of interest: none.
Presented at the Thirty-fourth Annual Meeting of the New England Society
for Vascular Surgery, Ledyard, Conn, Oct 5-7, 2007.
Reprint requests: Marc Schermerhorn, MD, Beth Israel Deaconess Medical
Center, 110 Francis St, 5B, Boston, MA 02215 (e-mail: mscherm@
Copyright © 2008 by The Society for Vascular Surgery.
protocol was approved by the Beth Israel Deaconess Med-
ical Center (BIDMC) Institutional Review Board.
Subjects and setting. All patients who underwent an
endovascular procedure performed by a member of the
Division of Vascular and Endovascular Surgery at the
BIDMC consecutively from February 2004 to March 2007
were recorded in a computerized vascular registry. Demo-
graphics, procedural details, and in-hospital outcomes are
prospectively recorded in this registry. From this database,
we retrospectively reviewed all patients who underwent an
attempt at a percutaneous, infrapopliteal angioplasty pro-
cedure on a native vessel.
Interventions were performed for critical limb ischemia
(CLI), defined as tissue loss, rest pain, or a stenosis in the
outflow vessel of a tibial bypass combined with low graft
flow velocities that threatened the graft viability. Not in-
cluded in this review are five interventions that were
performed during this time period for disabling claudi-
cation in patients who also had concurrent femoropop-
liteal disease. Preoperative segmental pressures and
Doppler waveforms were obtained in all elective cases. In
our patients with diabetes, we routinely obtain forefoot
pulse volume recordings because of the well-known un-
reliability of ankle-brachial index (ABI) measurements in
these patients. Palpable distal pulses were absent in all
patients, and all patients with preoperative vascular stud-
ies had dampened forefoot pulse volume recordings.
Most cases were performed in a dedicated angiography
suite, initially in a cardiac catheterization laboratory and
eventually in an operating room endovascular suite. A few
C-arm. Most procedures were performed under conscious
for patients unable to adequately lie still.
All patients were anticoagulated with heparin during
the procedure to an activating clotting time of 250 to 300
seconds. After the procedure, patients were given a loading
dose of clopidogrel and maintained on a 75-mg daily dose
for at least 30 days, along with aspirin and statin therapy
Cases were performed using 5F or 6F sheaths preferen-
tially through retrograde contralateral and occasionally
through antegrade ipsilateral access. No brachial or other
upper extremity access was used. Preference was given to
using 0.014- or 0.018-inch guidewire and catheter sys-
tems. Angioplasty was performed with noncompliant low-
profile balloons. Repeated 2- to 3-minute inflations or
cutting balloon angioplasty were performed if significant
residual stenosis or flow-limiting dissection was present
after a first angioplasty attempt. Subintimal angioplasty was
performed for complete occlusions that could not be
crossed within the lumen. Stents were placed only for
flow-limiting dissections or residual stenosis ?30% after
primary angioplasty. The type of stent used depended on
is a low-profile self-expanding nitinol stent.
Measurements. We recorded patient demographics,
TASC classification, indication, and bypass candidacy sta-
tus. The primary outcome variable was freedom from reste-
nosis, reintervention, or amputation. Secondary outcomes
were technical success, procedural and postoperative com-
plications, conventional primary patency, secondary reste-
nosis, tissue healing, limb salvage, reintervention, and pa-
TASC classification was assessed for the individual ves-
sel that underwent intervention. If more than one vessel
had a successful intervention, the limb was assigned the
worst of the TASC classes for lesions in series (eg, tibio-
peroneal trunk and posterior tibial) and the lesser class for
lesions in parallel (eg, anterior tibial and posterior tibial).
The indication for the procedure was classified as tissue
loss (gangrene or nonhealing ulcer) or rest pain. A few
patients were treated for the presence of tibial outflow
stenosis in the native tibial artery distal to an existing vein
graft with low graft velocities. All bypass grafts had initially
been placed for either tissue loss or rest pain.
Patients were deemed unsuitable candidates for a by-
pass procedure if they lacked a bypass target or an adequate
vein conduit. A small number of patients had underlying
conditions precluding surgery, including severe dementia,
significant medical comorbidities, nonambulatory status,
or open wounds overlying the only potential bypass target.
Outcome variables. Technical success was defined as
a residual stenosis of ?30% as assessed on single-view
completion angiography. Adjunctive procedures included
stent placement, mechanical atherectomy, mechanical
thrombectomy, thrombolysis, or intra-arterial nitroglyc-
erin infusion to treat flow-limiting spasm. Concomitant
procedures included superficial femoral artery, popliteal, or
vein graft angioplasty or stent placement, or both.
Patients were seen for follow-up typically at 2 weeks,
then every 3 months for 1 year, and every 6 months
thereafter, or more frequently if stenoses were detected or
to monitor wound healing. Restenosis and patency were
assessed with duplex ultrasound (DUS) analysis of the
treated vessel, Doppler waveforms, segmental pressures,
pulse volume recordings, and when indicated, angiogra-
phy. All noninvasive vascular studies were performed in one
of two vascular laboratories by a dedicated vascular techni-
cian and interpreted by a staff vascular surgeon.
The primary outcome was freedom from tibial resteno-
sis, reintervention, or major amputation. Restenosis was
Table I. TransAtlantic Inter-Society Consensus
classification for infrapopliteal lesions9
Classification Lesion characteristics
Single stenosis ?1 cm long
Multiple focal stenoses ?1 cm long or 1 or
2 stenoses ?1 cm involving the
Stenoses 1 to 4 cm long, occlusion 1 to 2
cm long, or extensive stenosis involving
Occlusion ?2 cm long or diffusely diseased
TASC, TransAtlantic Inter-Society Consensus.
JOURNAL OF VASCULAR SURGERY
Volume 48, Number 1
Giles et al 129
term follow-up and cost data are needed to thoroughly
define the appropriate role for infrapopliteal PTA.
Conception and design: MS, SB, AH, FP
Analysis and interpretation: SB, KG, HP
Data collection: SB, KG, HP
Writing the article: KG, SB
Critical revision of the article: MS, FP, AH
Final approval of the article: MS, KG, AH, FP
Statistical analysis: KG, MS, SB
Obtained funding: FP, AH, MS
Overall responsibility: MS
1. Pomposelli FB, Kansal N, Hamdan AD, Belfield A, Sheahan M, Campbell
DR, et al. A decade of experience with dorsalis pedis artery bypass: analysis
of outcome in more than 1000 cases. J Vasc Surg 2003;37:307-15.
2. Harrington EB, Harrington ME, Schanzer H, Jacobson JH, Haimov
M. The dorsalis pedis bypass—moderate success in difficult situations.
J Vasc Surg 1992;15:409-16.
3. Varty K, Nydahl S, Nasim A, Bolia A, Bell PR, London JM. Results of
surgery and angioplasty for the treatment of chronic severe lower limb
ischaemia. Eur J Vasc Endovasc Surg 1998;16:159-63.
4. Conte MS, Belkin M, Upchurch GR, Mannick JA, Whittemore AD,
Donaldson MC. Impact of increasing comorbidity on infrainguinal
reconstruction: a 20-year perspective. Ann Surg 2001;233:445-52.
5. Feinglass J, Pearce WH, Martin GJ, Gibbs J, Cowper D, Sorensen M.
Postoperative and amputation-free survival outcomes after femorodistal
bypass grafting surgery: findings from the Department of Veterans
Affairs National Surgical Quality Improvement Program. J Vasc Surg
The influence of subintimal angioplasty on level of amputation and limb
salvage rates in lower limb critical ischaemia: a 15-year experience. Eur
J Vasc Endovasc Surg 2005;30:291-9.
7. Adam DJ, Beard JD, Cleveland T, Bell J, Bradbury AW, Forbes JF, et al.
BASIL trial participants. Bypass versus angioplasty in severe ischemia of
the leg (BASIL): multicentre, randomized controlled trial. Lancet
8. Dormandy JA, Rutherford RB, TASC Working Group. TransAtlantic
Inter-Society Concensus (TASC). Management of peripheral arterial
disease (PAD). J Vasc Surg 2000;31:S1-296.
9. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes
FGR. Inter-Society Consensus for the Management of Peripheral Arte-
rial Disease (TASC II). Eur J Vasc Endovasc Surg 2007;33(suppl 1):
10. Kudo T, Chandra FA, Ahn SS. The effectiveness of percutaneous
balloon angioplasty for the treatment of critical limb ischemia: a 10-year
experience. J Vasc Surg 2005;41:3.
11. Rutherford RB, Baker JD, Ernst C, Johnston KW, Porter JM, Ahn S, et
al. Recommended standards for reports dealing with lower extremity
ischemia: revised version. J Vasc Surg 1997;26:517-38.
12. Haider SN, Kavanagh EG, Forlee M, Colgan MP, Madhavan P, Moore
DJ, et al. Two-year outcome with preferential use of Infrainguinal
angioplasty for critical ischemia. J Vasc Surg 2006;43:504-12.
13. Lofberg AM, Lorelius LE, Karacagil S, Westman B, Almgren B, Ber-
qgvist D. The use of below-knee percutaneous transluminal angioplasty
in arterial occlusive disease causing chronic critical limb ischemia.
Cardiovasc Intervent Radiol 1996:19:317-22.
14. Dorros G, Jaff MR, Dorros AM, Mathiak LM, He T. Tibioperoneal
(outflow lesion) angioplasty can be used as primary treatment in 235
patients with critical limb ischemia: five-year follow-up. Circulation
15. Faglia E, Mantero M, Caminiti M, Caravaggi C, De Giglio R, Pritelli C.
treatment of ischaemic diabetic foot ulcers: clinical results of a multi-
centric study of 221 consecutive diabetic subjects. J Intern Med 2002;
16. Kandarpa K, Becker GJ, Hunink M, McNamara TO, Rundback JH,
Trost DW, et al. Transcatheter interventions for the treatment of
peripheral atherosclerotic lesions: part 1. J Vasc Interv Radiol 2001;12:
17. Parsons RE, Suggs WD, Lee JJ, Sanchez LA, Lyon RT, Veith FJ.
Percutaneous transluminal angioplasty for the treatment of limb threat-
ening ischemia: do the results justify an attempt before bypass grafting?
J Vasc Surg 1998;28:1066-71.
Tibial angioplasty as an alternative strategy in patients with critical limb
ischemia: a 10-year experience. Ann Vasc Surg 2005;19:63-8.
19. Nasr MK, McCarthy RJ, Hardman J, Chalmers A, Horrocks M. The
increasing role of percutaneous transluminal angioplasty in the primary
management of critical limb ischaemia. Eur J Vasc Endovasc Surg
20. Matsagas MI, Rivera MA, Tran T, Mitchell A, Robless P, Davies AH.
Clinical outcome following infra-inguinal percutaneous transluminal
angioplasty for critical limb ischemia. Cardiovasc Intervent Radiol
21. Melliere D, Berrahal D, D’Audiffret A, Desgranges P, Allaire E, Bec-
quemin JP. Percutaneous transluminal angioplasty in patients with
ischemic tissue necrosis is worthwhile. Cardiovasc Surg 2001;9:122-6.
22. Balmer H, Mahler F, Do DD, Triller J, Baumgartner I. Balloon angio-
plasty in chronic critical limb ischemia: factors affecting clinical and
angiographic outcome. J Endovasc Ther 2002;9:403-10.
23. Danielsson G, Albrechtsson U, Norgen L, Ribbe E, Thome J,
Zdanowski Z. Percutaneous transluminal angioplasty of crural arteries:
diabetes and other factors influencing outcome. Eur J Vasc Endovasc
24. Vraux H, Hammer F, Verhelst R, Goffette P, Vandeleene B. Subintimal
angioplasty of tibial vessel occlusions in the treatment of critical limb
ischaemia: mid-term results. Eur J Vasc Endovasc Surg 2000;20:441-6.
25. Blair JM, Gewertz BL, Moosa H, Lu CT, Zarins CK. Percutaneous
transluminal angioplasty versus surgery for limb-threatening ischemia.
J Vasc Surg 1989;9:698-703.
26. Conte MS, Bandyk DF, Clowes AW, Moneta GL, Seely L, Lorenz TJ,
et al. Results of PREVENT III: a multicenter, randomized trial of
edifoligide for the prevention of vein graft failure in lower extremity
bypass surgery. J Vasc Surg 2006;43:742-51.
27. Molloy KJ, Nasim A, London NJ, Naylor AR, Bell PR, Fishwick G.
Percutaneous transluminal angioplasty in the treatment of critical limb
ischemia. J Endovasc Ther 2003;10:298-303.
28. Feinglass J, Pearce WH, Martin GJ, Gibbs J, Cowper D, Sorensen M, et
al. Postoperative and late survival outcomes after major amputation:
findings from the Department of Veterans Affairs National Surgical
Quality Improvement Program. Surgery 2001;130:21-9.
29. Aulivola B, Hile CN, Hamdan AD, Sheahan MG, Veraldi JR, Skillman
JJ, et al. Major lower extremity amputation: outcome of a modern
series. Arch Surg 2004;139:395-9.
E. Prospective trial of infrapopliteal artery balloon angioplasty for
critical limb ischemia: angiographic and clinical results. J Vasc Interv
Submitted Nov 12, 2006; accepted Feb 14, 2008.
JOURNAL OF VASCULAR SURGERY
136 Giles et al