Catheterization and Cardiovascular Interventions 76:1047–1054 (2010)

PERIPHERAL VASCULAR DISEASE

Original Studies

Angiographic Patency and Clinical Outcome After

Balloon-Angioplasty for Extensive
Infrapopliteal Arterial Disease
Andrej Schmidt,1,2* MD, Matthias Ulrich,1 MD, Bert Winkler,1 Christina Klaeffling,3 MD,
Yvonne Bausback,1 MD, Sven Bräunlich,1 MD, Spiridon Botsios,4 MD, Hans-Joachim Kruse,5 MD,
Ramon L. Varcoe,6 FRACS (Vasc), MD, Steven Kum,1 MD, and Dierk Scheinert,1,2 MD
Background and objective: Restenosis-rate after balloon-angioplasty of long segment
tibial arterial disease is largely unknown. We investigated the restenosis-rates angiograph-
ically in patients with critical limb ischemia (CLI) due to extensive infrapopliteal lesions.
Methods: Angioplasty for infrapopliteal lesions exclusively
80 mm in length was per-
formed using dedicated 80–120 mm long low-profile balloons. Follow-up included angiog-
raphy at 3 months and clinical assessment at 3 and 15 months. Results: Angioplasty was
performed in 77 infrapopliteal arteries of 62 limbs of 58 CLI patients with a Rutherford class
4 in 16 (25.8%) limbs and Rutherford class 5 in 46 limbs (74.2%). Average lesion length was
18.4 cm. Treated arteries were stenosed in 35.1% and occluded in 64.9%. After 3 months, a
clinical improvement (marked reduction of ulcer-size or restpain) was seen in 47 (75.8%)
limbs, 14 (22.6%) limbs were clinically unchanged and 1 (1.6%) limb showed a clinical dete-
rioration. Angiography at 3 months showed no significant restenosis in 24 of 77 (31.2%)
treated arteries, a restenosis
50% in 24 (31.2%) arteries and a reocclusion in 29 of 77
(37.6%). At 15 months death rate was 10.5%. After repeat angioplasty in case of restenosis
cumulative clinical results at 15 months were minor amputations in 8.1%, no major amputa-
tions resulting in a limb-salvage rate of 100% with no patient requiring bypass surgery.
Conclusions: Restenosis-rate after angioplasty of extensive infrapopliteal arterial disease
is high and occurs early after treatment. Despite this the clinical results are excellent, espe-
cially given the length of the arterial segments diseased. VC 2010 Wiley-Liss, Inc.

Key words: arterial occlusive disease; balloon angioplasty; tibial arteries; restenosis;
critical limb ischemia; limb salvage
INTRODUCTION
A growing number of publications demonstrate the
clinical success of endovascular treatment of infrapo-
pliteal arteries with obstructions of different complex-
ity in patients with critical limb ischemia (CLI) [1–5].
However, it is still believed that interventional treat-
ment is more successful in shorter rather than longer
lesions and bypass surgery is still recommended as first
choice therapy in case of extensively diseased infrapo-
pliteal arteries [6,7]. Unfortunately many CLI patients,
especially those with diabetes mellitus, present with
long diffuse arteriosclerotic disease below the knee
(BTK) [8]. These patients are however often, due to
concomitant diseases and advanced age, not good sur-
1
Department of Internal Medicine I, Angiology, Cardiology,
Park Hospital Leipzig, Leipzig, Germany
2
Department for Angiology, Heart Center Leipzig, Leipzig, Germany
3
Clinic for Cardiology Frankfurt University, Frankfurt, Germany
4
Department of Vascular Surgery, Park Hospital Leipzig, Germany
5
Department of Angiology, Zschopau, Germany
6
Department of Surgery, Prince of Wales Hospital and Univer-
sity of New South Wales, Sydney, Australia
Conflict of interest: Nothing to report.
*Correspondence to: Andrej Schmidt, MD, Medizinische Klinik I,
Angiologie, Kardiologie, Parkkrankenhaus Leipzig, Strümpellstrasse
41, Leipzig 04289, Germany. E-mail: andrej.schmidt@gmx.de
Received 16 April 2010; Revision accepted 10 May 2010
DOI 10.1002/ccd.22658
Published online 6 October 2010 in Wiley Online Library
(wileyonlinelibrary.com).

V
C 2010 Wiley-Liss, Inc.
1048 Schmidt et al.

gical candidates making an endovascular treatment All patients were taking aspirin 100 mg once daily.
preferable. Besides the scepticism as to whether long After sheath insertion, an intra-arterial bolus of 5,000
infrapopliteal obstructions can be treated intervention- IU heparin was administered. An additional 5,000 IU
ally with acceptable results at all, the high restenosis- unfractionated heparin was given for interventions that
rate of this arterial segment is thought to support lasted longer than 1 hr. After angioplasty intra-arterial
bypass surgery as first line therapy [9]. Data concern- nitroglycerine 200–300 lg was routinely administered
ing the restenosis-rate of infrapopliteal arteries is rare, to limit vasospasm. The regime of postinterventional
especially in cases of extensive BTK-disease, and the anticoagulation was left to the discretion of the inter-
reliability of duplex-sonography for analysis of resteno- ventionalist and may include Clopidogrel 75 mg once
sis of BTK-arteries is often questioned [2,10]. Further- daily for 4 or low-molecular weight heparin for
more, the importance of a restenosis for CLI patients 2 weeks. At a minimum all patients had at least 100
after treatment for exclusively long infrapopliteal mg aspirin daily live-long.
arteries is not clear.
Therefore, the purpose of this registry was to sys- Endpoints
tematically assess the restenosis-rate after successful
The primary endpoint of this study was to assess the
balloon-angioplasty of exclusively extensive infrapopli-
angiographical restenosis-rate after balloon-angioplasty
teal arterial disease and to evaluate the clinical signifi-
of long infrapopliteal arterial disease. Invasive follow-
cance of a restenosis for the patient with CLI.
up was scheduled at 3 months according to our hospital
standards. Selective angiography in two different angu-
METHODS lations was performed using an antegrade access via a
4 Fr sheath. Angiograms were analyzed on site by two
Consecutive patients with CLI and successful recan-
investigators based on visual estimate. Binary resteno-
alization of diffuse infrapopliteal arterial lesions (steno-
sis was calculated using a 50% diameter reduction
sis
70% or occlusion with a lesion-length of
80
threshold. Secondary endpoint was clinical outcome at
mm) were included in the study. Patients with shorter
3 and 15 months after angioplasty. Because 3 months
lesions were excluded. In a small percentage patients
after successful recanalization is a relatively short pe-
with inflow lesions were accepted, if the lesion was
riod and complete healing cannot be expected for all
estimated not to be the disease mainly responsible for
CLI patients at this time, we did not only measure the
CLI and angioplasty could be performed during the
clinical improvement by Rutherford classes but also
same treatment-session.
the tendency to heal as measured by marked (
50%)
Angioplasty was performed from either a cross-over-
reduction of ulcer-size/depth by visual assessment or
approach using a 5 or 6 French 90 cm sheath (Cook,
reduction of restpain. Furthermore, minor and major
Bloomington, IN) or an antegrade ipsilateral approach
amputations and the necessity for bypass-surgery were
using a 4 to 6 French sheath (Terumo, Tokyo, Japan).
assessed. Clinical status during follow-up was eval-
The stenosis or occlusion was crossed using a hydro-
uated by two physicians, accredited in internal medi-
philic tipped 0.01800 guidewire (V18-control [Boston
cine/angiology and vascular surgery, who are in charge
Scientific, Natick, MA]) or a hydrophilic tipped 0.01400
for wound-assessment and wound-treatment in our vas-
guidewire (PT2 [Boston Scientific]) with a length of
cular center.
300 cm. A dedicated support-catheter (Diver [Invatec,
An ankle-brachial-index (ABI) was not performed
Roncadelle, Italy]) or a balloon was directly used to
regularly due to the high percentage of mediasclerosis
support the guidewire. The balloons had a length of
in patients with diabetes mellitus [11] and the potential
80–120 mm and diameter of 2.0–3.5 mm (Submarine
hazard of compressing the recanalized artery through
Plus or Amphirion Deep [Invatec, Roncadelle, Italy]).
the external forces exerted by the pressure-cuff.
Diameters of 2.0–2.5 mm were used in the lower and
Duplex-ultrasound was also not performed regularly
middle part and diameters of 2.5–3.5 mm in the middle
during the follow-up examinations due to the well
and proximal part of the lower leg. Inflation-time was
known uncertainty in assessing the restenosis of infra-
initially 1 min with inflation pressures of 10–14 atmos-
popliteal arteries [2,10].
pheres. A second prolonged dilation of up to 5 min
was performed for an unsatisfactory result, either due
to residual stenosis >30% or a significant dissection. Statistical Analysis
Interventional success was defined as at least one infra- Continuous data are given as mean values  stand-
popliteal artery restoration in continuity without resid- ard deviation. For comparison of the clinical outcome
ual stenosis. All patients had a duplex study on day 1 within the whole study-group before treatment and dur-
after to confirm the patency of the target arteries. ing the follow-up examination the Wilcoxon-test was
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
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 Angioplasty of Extensive Infrapopliteal Disease 1049

TABLE I. Demographic Patient Data TABLE II. Location of Angioplasty

Mean age (years) (mean  SD) 70.5  8.08 N arteries
Male gender, n (%) 38 (65.5%) treated (% of Stenosis
Diabetes mellitus, n (%) 52 (89.7%) Location treated legs) (
70–99%) Occlusion
Smoking habit, n (%) 11 (19.0%)
Art. hypertension, n (%) 56 (96.6%) Proximal angioplasty 14 (23%) 12 2
Hypercholesterolemia, n (%) 31 (53.4%) CFA 1 (2%) 1 0
Coronary artery disease, n (%) 29 (50.0%) SFA 6 (10%) 6 1
Renal insufficiency (Crea >1.5 mg /dl), n (%) 30 (51.7%) Popliteal artery 7 (11%) 5 1
Cerebrovascular disease, n (%) 9 (15.5%) Infrapopliteal angioplasty 77 (100%) 27 50
ASA-score (mean  SD) 3.31  0.64 Anterior tibial artery 32 (52%) 11 21
ASA-score III 35 (60.3 %) Posterior tibial artery 25 (40%) 9 16
ASA-score IV 19 (32.8 %) Peroneal artery 18 (29%) 9 9
Tibioperoneal trunk 2 (3%) 0 2

TABLE III. Diameter of Balloons Used for Angioplasty (in mm)

used. For the investigation of the influence of an addi-
tional angioplasty of lesions proximal to the tibial
arteries and a re-PTA during the 3-month follow-up on
the clinical outcome the Mann-Whitney-U-test was per-
formed. In cases of analysis of more than two inde-
pendent samples like the influence of the arterial status
during follow-up on the clinical situation, the H-test of
Kruskal-Wallis was used. A P-value of <0.05 was con-
sidered statistically significant. The software used for
statistical analysis was the SPSS version 12.0.
RESULTS
Patients
Between December 2003 to March 2007, 168 crit-
ically ischemic limbs in 145 patients fulfilling the
inclusion criteria (extensive infrapopliteal arterial dis-
ease
80 mm in length) were treated through endovas-
cular means in our center. In 144 (85.7%) limbs tech-
nical success with restoration of at least one vessel was
achieved. As our hospital serves as a supraregional
referral center, only patients living a reasonable dis-
tance from our hospital were rescheduled for the 3-
months angiographical follow-up examinations at our
center. These were 77 patients, for which no other
selection criteria applied. The remaining patients were
followed locally by the referring hospitals or practi-
tioners. Of this group of 77 patients 58 (75%) returned
for the 3-months follow-up. Reasons of the 19 patients
(25%) not to return for follow-up were different but
mainly unwillingness to undergo repeat hospitalization
and angiography.
In the 58 patients, who represent the study-group, 77
of 81 (95.1%) infrapopliteal arteries of 62 legs with
critical ischemia were successfully treated by balloon-
angioplasty. The demographic data of these patients
are given in Table I.
CLI was classified as Rutherford category 4 in 16/62
(25.8%) limbs and Rutherford category 5 in 46/62
Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
3.5 mm 3.0 mm 2.5 mm 2.0 mm
3% 9% 52% 36%
limbs (74.2%). Inevitable minor amputation was per-
formed prior to angioplasty in 10 patients (9 toes and 1
transmetatarsal amputation). Before treatment 17 legs
had one patent BTK artery, which was in all except
three cases the peroneal artery. The other 45 legs had
complete or functional occlusion of all three tibial
arteries. 35.1% of target arteries were stenosed and
64.9% occluded. The average lesion length was 18.3 
7.5 cm, with 16.9  7.5 cm in the stenosed vessels
and 19.2  7.4 cm in the occluded ones.
Angioplasty
The artery revascularized and the number of arteries
to be treated was in each case left to the discretion of
the interventionist performing the procedure. A single
artery was revascularized in 51 limbs, two vessels in
10 limbs, and all three in two limbs resulting in 77
recanalized arteries (Table II). In four limbs recanaliza-
tion of the target, infrapopliteal artery was unsuccessful
however in each instance recanalization of an alterna-
tive tibial artery was possible. In a single case, a retro-
grade approach via a transpedal access was attempted
and was successful after failure from the antegrade
approach. Mean balloon diameter for the tibial arteries
was 2.36  0.36, mainly 2.5 mm and 2.0 mm balloons
were used (Table III). In 14/62 limbs (22.6%) an
inflow lesion was treated during the same intervention
(Table II). Bail-out stenting was performed in 11 cases
for significant dissections that did not resolve after a
second prolonged balloon-dilatation. In all of these
cases, a coronary balloon-expandable stent was used
with a maximum length of 33 mm (Sonic, Cordis Cor-
poration, Miami Lakes, US). A residual stenosis less
than 30% was technically acceptable.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
1050 Schmidt et al.

Fig. 1. (a) Total occlusion of the anterior tibial artery, subtotal stenosis of the proximal part
of the peroneal artery and occlusion of the distal posterior tibial artery. (b) After angioplasty
of the anterior tibial artery and peroneal artery. (c) Reocclusion of the anterior tibial artery
and restenosis of the peroneal artery 3 months later.

Peri-Procedural Outcomes amputation performed, resulting in a limb-salvage rate

Early failure with reocclusion was detected by
duplex ultrasound in one artery on day 1 and repeat
angioplasty performed to successfully recanalize. Com-
plications prior to discharge were one groin haematoma
requiring surgical correction and blood transfusion, one
groin haematoma managed conservatively and one
femoral pseudoaneurysm that was successfully treated
with ultrasound guided compression. Guidewire perfo-
ration during passage of an occluded tibial artery
occurred in a single patient who suffered no adverse
consequences. There was no angiographic or clinical
evidence of peripheral embolization in any patient.
Follow-Up
At 3 months follow-up (mean 3.5  1.6 months),
clinical improvement (reduction in size and/or depth of
ulceration or improvement of restpain) was seen in 47/
62 (75.8%) limbs, 14/62 (22.6%) were clinically
unchanged and 1/62 (1.6%) limb deteriorated. Improve-
ment of at least one Rutherford category was found in
33/62 (53.2%) limbs. Minor amputations had to be per-
formed in 5/62 (8.1%) limbs (four toes, one metatarsal)
during the time-span from day 0 to the 3 months fol-
low-up. There was no bypass surgery and no major
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
of 100% at 3 months.
Three month angiography found <50% restenosis in
24 of the 77 treated arteries (31.2%), a restenosis

50% in 24/77 (31.2%) vessels and an occlusion in
29/77 (37.6%) (Fig. 1). Of all 53 arteries with resteno-
sis or reocclusion the entire treated segment was
effected in 43/53 (81%), whereas in only 10 arteries
(19%) the restenosis was focal, not involving the entire
treated segment. The mean length of the restenosed or
reoccluded segment was 15.5  8.7 cm. When limbs
rather than arteries were examined 35.5% had at least
one treated artery free of restenosis with 64.5% having
all treated vessels restenosed or occluded. Angiography
at 3 months was performed as selective angiography
and the amount of contrast usually did not exceed 60
ml. None of the patients developed clinically apparent
contrast nephropathy later on.
In patients/limbs without restenosis improvement of
at least one Rutherford category was found in 68.2%
and in 52.5% if restenosis or reocclusion occurred,
which was not significantly different (P ¼ 0.67). How-
ever, patients which were found to have all three
arteries occluded at the 3-months follow-up (23/62)
faired significantly clinically worse with improvement
of at least one Rutherford-category in only 39.1% com-
pared with those with at least one artery without

TABLE IV. Clinical Improvement in Correlation to Restenosis
at the 3 Months Follow-Up
3 Months improvement of
Limbs at least one Rutherford class
No restenosis 68.2%
With restenosis 52.5%
>1 Artery free of restenosis 75.0%*
1 Artery free of restenosis 61.5%*
All 3 arteries occluded 39.1%a
*P ¼ 0.025.
a
Compared with P ¼ 0.025.
TABLE V. Clinical Improvement at 15 Months in Correlation to
Repeat Angioplasty
15 months FU clinical improvement
(at least one Rutherford class)
Angioplasty at No angioplasty at
3 month FU 3 month FU
Compared with baseline 69.6% 82.1%
Compared with 3 month FU 60.9% 42.9%
FU ¼ follow-up; angioplasty compared with no angioplasty P ¼ NS.
restenosis (31/62) or those with more than one artery
free of >50% restenosis (8/62), where clinical improve-
ment of at least one Rutherford-category was seen in
61.3% and 75.0% respectively (P ¼ 0.025) (Table IV).
Comparison of the 14 patients who had an additional
angioplasty of inflow lesions to those with exclusively
infrapopliteal lesions showed no difference in clinical
improvement (87.6% vs. 75.0%; P ¼ 0.57) or improve-
ment of at least one Rutherford category (57.1% vs.
54.2%; P ¼ 0.62).
At the 3-month angiographic follow-up reinterven-
tion with balloon-angioplasty was performed in 31/62
limbs (50%). The indication for reintervention was
ongoing CLI (Rutherford category 4 and 5), or in the
context of progressive wound-healing if all 3 arteries
showed significant disease (
50% stenosis or occlu-
sion).
Long-term clinical data were collected after a mean
follow-up of 15.4  6.2 months. One patient was lost
to follow-up, leaving 57 patients for further analysis.
Six of fifty-seven (10.5%) patients died during this pe-
riod, three due to cardiac disorders, two of unknown
causes, and one patient died due to pancreatic cancer,
leaving 51 patients with 51 treated limbs for the long
term analysis. Comparable with the 3-months results,
76.5% of the limbs showed further clinical improve-
ment (marked reduction of ulcer size/ depth or rest-
pain) and 51% improved at least one Rutherford cate-
gory. Patients showed similar clinical improvement (at
least one Rutherford class) whether they were reinterv-
ened at 3 months or not, whether compared with the
Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Angioplasty of Extensive Infrapopliteal Disease 1051
Fig. 2. Rutherford classes at baseline and follow-up.
clinical situation at baseline or with the 3-months fol-
low-up situation (Table V). At 15 months 2/51 limbs
were still in Rutherford category 4 and 11/51 in Ruth-
erford category 5 (Fig. 2). Beyond 3 months posttreat-
ment no additional minor amputations were necessary.
No major amputation occurred and no bypass surgery
was required, resulting in a limb salvage rate of 100%.
DISCUSSION
Target lesion selection is thought to be crucial to the
success of endovascular therapy for crural arteries in
patients with CLI [6,7]. The TransAtlantic InterSociety
Consensus (TASC-I) guidelines published in 2000 cate-
gorized stenoses with a length of 1–4 cm and occlu-
sions longer than 2 cm as TASC C and D lesions
respectively. They recommended these to be treated
surgically in preference to an endovascular approach.
In adherence to these guidelines, it was estimated that
only 20–30% of patients with tibial disease would have
favorable anatomy for an endovascular approach [12].
The recently revised TASC-II guidelines state ‘‘There
is increasing evidence to support a recommendation for
angioplasty in patients with CLI and infrapopliteal ar-
tery occlusion.’’ Although lesion length was no longer
used to determine a recommendation for treatment,
angioplasty of longer infrapopliteal lesions is still
believed to result in an inferior outcome compared to
shorter lesions [6].
In this study, we could demonstrate that using long
balloons designed for the treatment of extensive infra-
popliteal disease very acceptable clinical results can be
achieved. Besides the mean lesion-length of 183 mm, a
high proportion of occlusions (65%) added to the com-
plexity of the lesions. Our results are consistent with the
few preceding publications that have demonstrated
angioplasty of these long lesions is technically feasible
and derives an excellent clinical response [3,4,13].
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
1052 Schmidt et al.
Furthermore, we intentionally selected patients with pre-
dominantly isolated infrapopliteal disease to demonstrate
more clearly the effect of angioplasty of this arterial
segment explicitly on the healing-process. With 100%
limb-salvage after a mean follow-up of 15 months, we
had similar success to that which was achieved in
another publication with 107 patients and exclusively
balloon-angioplasty of long obstructions of the tibial
segment [3], which achieved 93% limb-salvage after a
follow-up of 3 years. These results suggest that an
interventional recanalization technique in such patients
is not inferior in terms of clinical outcome compared
with pedal-bypass surgery. Complications in our study
were uncommon which is consistent with other series
[3,4,13]. Access-site complications are rare using 4 or
5 Fr sheaths, which are sufficient for balloon-catheters
dedicated for tibial interventions. It is of note that pe-
ripheral embolization was not encountered in our
patients nor in similar series [3,4,13]. This may indi-
cate a low thrombus burden in these lesions, even in
total occlusions.
Restenosis of infrapopliteal angioplasty has long
been a criticism of the technique despite a very limited
number of studies quantifying it with angiogram [9].
The key objective of our study was the angiographical
assessment of the restenosis-rate after infrapopliteal
angioplasty and therefore adds significantly to the pau-
city of data. The few publications available with angio-
graphic follow up have demonstrated both a high reste-
nosis and low patency rate. Rand et al. [15] found a
patency-rate of 45.6% 6 months after balloon-angio-
plasty in lesions with a mean lesion-length of 24 mm
using CT-angiography. Soder et al. [5] found a binary
restenosis rate of 48% at 10 months following balloon-
angioplasty of relatively short lesions (mean length
77 mm) compared with our patient-group. It is not sur-
prising that the restenosis-rate was directly proportional
to the length of the lesion in that study. Until now, no
one has angiographically investigated the restenosis
rate of extensive lesions as long as in our study. Using
duplex-sonography Ferraresi et al. [3] found a resteno-
sis in 47% at 1 year after balloon-angioplasty of
obstructions with a mean lesion-length of 210 mm.
Our angiographical restenosis-rate of 68.8% in a
patient-group with a similar mean lesion-length of 183
mm only 3 months after PTA is clearly much higher.
Several authors have questioned the reliability of
duplex-ultrasound for the evaluation of restenosis in
this region [2,10] suggesting it differs from other arte-
rial segments like the superficial femoral artery. Well-
conducted evaluations of duplex-criteria comparing it
to the gold-standard of angiography do not exist for
the infrapopliteal region [16]. Accordingly Bosiers
et al. [2] found no correlation between duplex ultra-
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
sound and angiography in assessing restenosis after an
interventional treatment of tibial arteries and that
duplex systematically underestimated the degree of re-
stenosis compared to angiography.
The question remains whether restenosis is a clini-
cally relevant endpoint in CLI. Additional blood flow
whilst required for ulcer healing and resolution of
infection may not be needed for maintaining skin in-
tegrity, therefore a restenosis after healing may confer
no clinical deterioration [3,11,17]. As such, despite our
high-restenosis rate, 68.8% at 3 months, 75.8% were
clinically improved and no limbs were lost even out to
15 months. Although we have followed recommended
reporting standards for endovascular revascularization
by using binary restenosis, it is possible, however, that
patency is the more clinically relevant endpoint [10].
We found that 62.4% were patent on angiography
which closely aligned to the 75.8% of those patients
showing clinical improvement and the 53.2% that
improved Rutherford categories.
Time to complete healing after recanalization varies
widely and can be prolonged with a mean healing time
of 3–5 months or even longer [4,18,19]. In support of
this, 53% of the limbs in our study were still classified
Rutherford category 4 or 5 after 3 months. Therefore,
an examination for a potential restenosis during the
healing-process in those with a slow healing rate or
incomplete healing after a distinct period of time might
be justified as restenosis might influence further heal-
ing negatively. In fact, although 52% of the patients
with restenosis showed a clinical improvement after
3 months in our series, those without restenosis seemed
to improve the most and patients with an occlusion of
all three arteries were the least healed group with only
39% clinical improvement over the first 3 months. We
therefore suggest that repeat angioplasty is reasonable
in those with restenosis and additionally in those with
recurrent three-vessel disease due to restenosis at this
time. However, further studies comparing patients with
planned reangiograms to a patient-group with strict
indications for a repeat angiography/angioplasty are
necessary to define the optimal strategy.
There is much tibial angioplasty technique that
remains uncertain as well as future technological
improvements which may result in better outcomes in
this challenging group of patients. Several technical
issues warrant discussion. First the choice of the bal-
loon-diameter, which was 2.4 mm in mean in our se-
ries, might be considered rather conservative and a
more aggressive treatment might have led to a higher
patency-rate. Additionally duration of the balloon-infla-
tion time longer than 1 min, as in our patient-group,
might be superior. As demonstrated by another work-
ing-group, inflation-times of 10 min are practicable [3].

Some other groups have a preference for a subintimal
recanalization technique rather than our preferred trans-
luminal wire passage [13]. Success-rates and clinical
results are difficult to compare and angiographic reste-
nosis-data do not exist for this technique. Our tech-
nique for infrapopliteal occlusions, as of other work-
ing-groups [3], is to attempt an intravascular recanali-
zation, which seems to be possible in most of the cases
and to reserve the subintimal recanalization-technique
in case of failure. The use of bare metal and drug elut-
ing stents [20] to improve the patency-rate has shown
some promise, however they have never been used in
long tibial arterial disease systematically to improve
the outcomes. Finally, drug-coated balloons have
recently come in to the mix with early trials suggesting
reduced restenosis in the superficial femoral artery
[21].
Limitations of the Study
In this registry, patients were only included after a
successful intervention, which was achieved in 85.7%
of our patient-population during the study-period. By
including the unsuccessful attempts in the analysis the
clinical results would likely have been inferior. How-
ever, recently, we showed that using more sophisti-
cated techniques such as the retrograde transpedal
approach [22] a much higher technical success-rate can
be achieved in these extensive infrapopliteal obstruc-
tions.
Although no exclusion criteria, patients with major
tissue loss (Rutherford class 6) did not participate in
this registry. These patients have an established higher
risk of limb loss which may have skewed our result.
Not all patients assigned for the 3-months follow-up
were willing to undergo repeat angiography, therefore
restenosis-results might be biased. However, to expect
more than 75% to return for follow-up is unrealistic in
this patient-group of advanced age and many comor-
bidities.
CONCLUSION
The restenosis-rate after balloon-angioplasty of
extensive infrapopliteal disease is particularly high. De-
spite this, excellent clinical results can be achieved.
Larger and potentially randomized studies must be per-
formed to investigate whether it is reasonable to incor-
porate repeat angioplasty into the treatment algorithm
for all patients with extensive infrapopliteal lesions or
only those with unsatisfactory healing. All future tech-
niques will be held to account up against these very re-
spectable clinical results achieved with simple balloon-
angioplasty.
Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Angioplasty of Extensive Infrapopliteal Disease 1053
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