J ENDOVASC THER

2008;15:383–389 383

¤CLINICAL INVESTIGATION ¤

Complications After Peripheral Vascular Interventions

in Octogenarians
Petra Dick, MD; Borner Barth, MD; Wolfgang Mlekusch, MD; Schila Sabeti, MD;
Jasmin Amighi, MD; Oliver Schlager, MD; Renate Koppensteiner, MD; Erich Minar, MD;
and Martin Schillinger, MD

Department of Angiology, Medical University Vienna, Austria.

¤ ¤
Purpose: To investigate the incidence of complications after peripheral vascular
interventions in patients aged 80 years and older compared to patients below the age of 80.
Methods: During a 20-month period, 619 consecutive patients (354 men; mean age
67 years, range 59–87) undergoing balloon angioplasty and stenting for lower limb
revascularization were enrolled in the study. The incidence of procedure-related, access-
site, and major complications within 30 days post intervention were recorded and
compared between patients aged 80 years and older (n572, 11.6%) and those under
80 years of age.
Results: Complication rates were significantly higher in octogenarians compared to
patients below 80 years, including the rates of overall complications (18.1% versus 8.5%,
p50.010), major complications (11.1% versus 1.8%, p,0.001), all access site complications
(12.5% versus 4.9%, p50.009), and access site bleeding complications (12.5% versus 2.2%,
p,0.001). By multivariable analysis, octogenarians had a 2.49-fold increased adjusted risk
(95% CI 1.10 to 5.65, p50.029) for any postintervention complication and a 10.99-fold
increased adjusted risk (95% CI 2.76 to 45.74, p50.001) for major complications compared
to patients below 80 years. No specific risk factor for complications or major complications
within the octogenarian population could be identified.
Conclusion: Patients aged 80 years and older have a dramatically increased risk,
particularly for major complications, after peripheral vascular interventions. Identification
of risk factors and development of preventive strategies are urgently needed to improve
procedure safety in this extremely vulnerable population.
J Endovasc Ther 2008;15:383–389
Key words: peripheral artery disease, peripheral interventions, balloon angioplasty, stent,
revascularization, complications, age, octogenarians
¤ ¤

Endovascular therapy for revascularization of related complications also increases.2–9 Cur-

peripheral artery disease (PAD) yields high
technical and clinical success rates and
generally a low incidence of complications.1
The minimally invasive approach, therefore,
is considered the first therapeutic option for
revascularization, particularly in morbid pop-
ulations and elderly patients. However, with
advanced patient age, the risk for procedure-
rent data on the risks in octogenarians mainly
come from coronary and carotid interven-
tions.3–9 In particular, the occurrence of
bleeding, renal failure, and systemic athero-
thrombotic events, such as myocardial infarc-
tion and stroke, seem to influence the out-
come of percutaneous procedures in elderly
patients.5,8,9 The hazards associated with

The authors have no commercial, proprietary, or financial interest in any products or companies described in this article.
Address for correspondence and reprints: Martin Schillinger, MD, Department of Angiology, Medical University Vienna,
Vienna General Hospital, Waehringer Guertel 18-20, A 1090 Vienna, Austria. E-mail: martin.schillinger@meduniwien.ac.at

ß 2008 by the INTERNATIONAL SOCIETY OF ENDOVASCULAR SPECIALISTS Available at www.jevt.org

384 PERIPHERAL VASCULAR INTERVENTIONS IN OCTOGENARIANS
Dick et al.
peripheral vascular interventions in elderly
patients are less extensively investigated.
We investigated the incidence of procedur-
al, access-site, and major complications with-
in 30 days after lower limb revascularization
in patients aged 80 years and older compared
to patients below the age of 80. Furthermore,
we sought to identify predictors for these
complications within the octogenarian popu-
lation.
METHODS
A prospectively maintained registry database
was interrogated to identify all consecutive
patients with atherosclerotic PAD who under-
went lower limb revascularization procedures
within a recent 20-month period. Patients
with intermittent claudication were included,
as were those with chronic critical limb
ischemia (CLI) who underwent balloon angio-
plasty and stenting in the iliac, femoropopli-
teal, and/or tibioperoneal segments. Patients
undergoing local thrombolysis or brachyther-
apy were excluded. Laser atherectomy, cryo-
plasty, and other debulking techniques were
not performed at our institution during the
study period. No other specific inclusion or
exclusion criteria were applied. The registry
was approved by the Institutional Review
Board and Ethics Committee, and all patients
provided written informed consent.
From the initial search, 619 consecutive
patients (354 men; mean age 67 years, range
59–87) undergoing balloon angioplasty and
stenting for lower limb revascularization were
enrolled in the study. Demographic data and
clinical characteristics of the octogenarians
(n572, 11.6%) compared to patients below
the age of 80 years are given in Table 1.
Patient Data
Demographic data, clinical characteristics,
traditional cardiovascular risk factors, current
medication, laboratory findings, intervention-
al data, and patient outcomes were recorded.
All patients underwent standard laboratory
testing including complete blood count, glob-
al coagulation tests, and lipid parameters at
baseline. Interventional data included access
site, access route, sheath size, target lesion
J ENDOVASC THER
2008;15:383–389
length, degree of stenosis, interventional
strategy (balloon angioplasty with or without
stenting), duration of fluoroscopy, amount of
contrast agent, dosage of heparin, and occur-
rence of periprocedural complications. Du-
plex ultrasound was performed in all patients
the day after the procedure and included an
assessment of the access site as well as re-
evaluation of the treated segment. Accuracy
of all data within the registry was checked by
two independent physicians.
Study Endpoints
The primary endpoint was the occurrence
of any complication up to 30 days, including
procedure-related (artery rupture, emboliza-
tion resulting in CLI, acute or subacute
occlusion, access-site bleeding during or after
the procedure) and access-site sequelae
(pseudoaneurysms, arteriovenous fistulas,
hematoma of any size, retroperitoneal bleed-
ing, or puncture-related vascular dissection/
occlusion of the access vessel) diagnosed by
duplex ultrasound or computed tomography
(CT). The secondary endpoint was the occur-
rence of major complications, including
myocardial infarction (MI), stroke, or major
bleeding.
Definitions
Rupture of the treated artery was defined as
pulsatile extravasation of contrast media
visualized by angiography. Critical emboliza-
tion was defined as de novo flush occlusion
of all outflow vessels distal to the treated
segment associated with acute onset or
significant worsening of ischemic rest pain
that could not be resolved by endovascular
techniques within the same session. Acute
(,24 hours) or subacute (#30 days) occlusion
of the treated segment was assessed by
duplex ultrasound and confirmed by repeat
angiography of the target vessel. Major
bleeding was defined as bleeding resulting
in a decrease in hemoglobin by 2 mg/dL or
requiring transfusion or surgical or endovas-
cular repair.
MI was defined as chest pain associated
with electrocardiographic ST-segment eleva-
tion in at least 2 leads, and/or de novo left
J ENDOVASC THER PERIPHERAL VASCULAR INTERVENTIONS IN OCTOGENARIANS 385
2008;15:383–389 Dick et al.

¤ ¤
TABLE 1
Demographic Data and Clinical Characteristics of Patients Aged 80 or Above
Compared to Patients Below the Age of 80
,80 Years (n5547, 88%) $80 Years (n572, 12%) p
Age 67 (59–74) 84 (81–87) —
Male sex 329 (60%) 25 (35%) ,0.001
Body mass index, kg/m2 25.9 (23.8–28.5) 24.1 (22.0–25.7) ,0.001
Hypertension 405 (74%) 54 (75%) 0.86
Diabetes mellitus 213 (39%) 23 (32%) 0.25
Current smoking 241 (33%) 7 (10%) ,0.001
Hyperlipidemia 438 (80%) 56 (78%) 0.65
Hemoglobin, mg/dL 13.9 (12.6–14.9) 13.0 (11.9–13.7) ,0.001
Thrombocyte count, g/L 248 (202–284) 234 (107–285) 0.44
Activated partial thromboplastin time, s 34.1 (31.7–37.5) 30.4 (32.2–36.4) 0.013
Glycated hemoglobin,% 6.2 (5.7–7.0) 6.4 (5.9–7.0) 0.22
LDL cholesterol, mg/dL 125 (103 to 152) 115 (87 to 133) 0.003
C-reactive protein, mg/dL ,0.5 (,0.5–1.0) ,0.5 (,0.5–0.9) 0.46
PAD stage 0.003
Intermittent claudication 444 (81%) 46 (64%)
Ischemic rest pain 39 (7%) 10 (14%)
Ischemic ulcers 64 (12%) 16 (22%)
Maximum walking distance, m 82 (34–141) 50 (0–100) 0.011
Baseline ABI 0.57 (0.41–0.72) 0.53 (0.39–0.64) 0.11
Coronary artery disease ,0.001
CCS 1 116 (21%) 30 (42%)
CCS 2 103 (19%) 16 (22%)
CCS 3 13 (2%) 3 (4%)
History of MI 124 (23%) 23 (32%) 0.082
History of stroke 73 (13%) 9 (13%) 0.92
ASA (100 mg/d) 365 (67%) 54 (75%) 0.16
Clopidogrel (75 mg/d) 180 (33%) 22 (31%) 0.69
Phenprocoumon 54 (10%) 4 (6%) 0.24
Statin therapy 308 (56%) 40 (56%) 0.90
Target segment 0.21
Iliac 140 (26%) 12 (17%)
Femoropopliteal 311 (57%) 48 (67%)
Tibioperoneal 96 (18%) 12 (17%)
French size 0.28
4 42 (8%) 8 (11%)
5 68 (12%) 7 (10%)
6 282 (52%) 44 (61%)
7 157 (29%) 13 (18%)
Contrast agent, mL 180 (119–230) 153 (110–200) 0.028
Heparin, U 5000 5000 —
Stent implantation 225 (41%) 17 (24%) 0.004
Closure device 149 (27%) 12 (17%) 0.055
¤ ¤
Data are given as medians and interquartile range (from the 25th to the 75th percentile) or counts and percentages.
LDL: low-density lipoprotein, PAD: peripheral artery disease, ABI: ankle-brachial index, CCS: Canadian
Cardiovascular Society, MI: myocardial infarction. ASA: acetylsalicylic acid.

bundle branch block, and/or elevation of
creatine kinase (CK)/CK-MB cardiac enzymes.
The occurrence of stroke was diagnosed by
an independent neurologist and was verified
by cranial magnetic resonance imaging or
cranial computed tomography (CT) (.24
hours after onset of symptoms). Renal failure
was defined by the necessity to perform
intermittent or permanent renal replacement
therapy.
386 PERIPHERAL VASCULAR INTERVENTIONS IN OCTOGENARIANS J ENDOVASC THER
Dick et al. 2008;15:383–389

¤ ¤
TABLE 2
Complications After Lower Limb Percutaneous Procedures in Patients Aged 80 or Above
Compared to Patients Below the Age of 80
,80 Years $80 Years
(n5547, 88%) (n572, 12%) p
Overall complications 47 (8.5%) 13 (18.1%) 0.010
Periprocedural complications 1 (0.2%) 2 (2.8%) 0.037
Arterial rupture 0 2 (2.8%) 0.013
Access site bleeding 1 (0.2%) 0 0.99
Critical embolization 0 0 —
Major complications 10 (1.8%) 8 (11.1%) ,0.001
Myocardial infarction 1 (0.2%) 4 (5.6%) ,0.001
Stroke 7 (1.3%) 2 (2.8%) 0.32
Renal failure 1 (0.2%) 1 (1.4%) 0.22
Major bleeding 1 (0.2%) 1 (1.4%) 0.22
Any bleeding complication 12 (2.2%) 9 (12.5%) ,0.001
Groin hematoma 10 (1.8%) 8 (11.1%) ,0.001
Retroperitoneal hematoma 1 (0.2%) 0 0.99
Major bleeding 1 (0.2%) 1 (1.4%) 0.22
Other access-site complications 27 (4.9%) 9 (12.5%) 0.009
Pseudoaneurysm 16 (2.9%) 4 (5.5%) 0.27
Areteriovenous fistula 4 (0.5%) 0 0.99
Groin infection 0 0 —
Access vessel dissection/occlusion 5 (0.9%) 1 (1.4%) 0.52
Late bleeding (.24 hours) 3 (0.6%) 4 (5.5%) 0.004
Target segment acute/subacute occlusion 10 (2.8%) 0 0.62
¤ ¤

Statistical Analysis icant. Calculations were performed using

Continuous data are given as medians and
interquartile range (from the 25th to the 75th
percentile); discrete data are presented as
counts and percentages. Chi-square, Mann-
Whitney U, and Fisher exact tests were applied
for univariate comparisons, as appropriate.
Multivariable logistic regression analysis was
done to assess the risk for overall complica-
tions and major complications in octogenari-
ans compared to patients below the age of 80
and to adjust for potentially confounding
factors. Variables in the univariate analysis
that were imbalanced between the 2 age
groups (indicated by p,0.1) and established
predictors of complications were entered into
the multivariable model as covariates. The
results of the logistic regression models are
presented as the odds ratio (OR) and the 95%
confidence interval (95% CI). Multiplicative
interaction terms and log likelihood ratio tests
were used to assess potential interactions
between baseline variables, patient age, and
occurrence of complications. The Hosmer-
Lemeshow test was used to assess the model
fit. P,0.05 was considered statistically signif-
SPSS for Windows (version 15.0; SPSS Inc.,
Chicago, IL, USA).
RESULTS
Complication rates were markedly higher in
octogenarians compared to younger patients
for most parameters (Table 2). The rate of
overall complications (18.1% versus 8.5%,
p50.010), major complications (11.1% versus
1.8%, p,0.001), all access-site complications
(12.5% versus 4.9%, p50.009), and access-site
bleeding (12.5% versus 2.2%, p,0.001) were
significantly more frequently encountered in
octogenarians compared to patients below
80 years, respectively.
By multivariable analysis, octogenarians
had a 2.49-fold increased adjusted risk (95%
CI 1.10 to 5.65, p50.029) for any postinterven-
tion complication and a 10.99-fold increased
adjusted risk (95% CI 2.76 to 45.74, p50.001)
for major complications compared to youn-
ger patients, respectively. The final models
were adjusted for gender, body mass index,
current smoking, low-density lipoprotein cho-
J ENDOVASC THER PERIPHERAL VASCULAR INTERVENTIONS IN OCTOGENARIANS
2008;15:383–389
lesterol, hemoglobin level, activated partial
thromboplastin time at baseline, history of
MI, PAD stage (intermittent claudication, rest
pain, ischemic ulcers), maximum walking
distance, coronary artery disease, use of
stents, use of closure devices (Vasoseal,
Angioseal, or Perclose), and amount of con-
trast agent.
Multivariate analysis did not identify any
significant predictor for complications within
the octogenarian group. In particular, the
presence of CLI did not add to the risk of
octogenarian status (p50.67, log likelihood
ratio). Furthermore, the use of arterial closure
devices was not significantly associated with a
reduction in access site complications in either
age group, although the number of patients
receiving a closure device was quite small.
DISCUSSION
Octogenarians had a dramatically increased
risk for major and minor complications after
percutaneous interventions in lower limb
arteries compared to younger patients. An
11% incidence of major complications and an
18% incidence of overall complications con-
tradict the general notion of ‘‘safe’’ endovas-
cular procedures in elderly patients. Unfortu-
nately, we were unable to identify specific risk
factors for poor outcome within the octoge-
narian population.
Several issues arise when discussing the
underlying pathophysiology of the increased
risk for complications after endovascular
procedures in the octogenarian population.
Firstly, elderly patients are more likely to
suffer from coronary artery disease, including
more extensive coronary atherosclerosis and
mainly diffuse multivessel coronary disease,
with higher prevalence of previous coronary
bypass surgery. Additionally, congestive
heart failure, evidence of left ventricular
hypertrophy, and a lower left ventricular
ejection fraction are more common in this
age group, as well as PAD, renal insufficiency,
and pulmonary disease.5,6,10 It is, therefore,
not surprising that higher periprocedural
complication rates have been reported after
coronary interventions in these patients.1
Interestingly, the distribution of risk factors
in octogenarians differs compared to younger
387
Dick et al.
patients, especially those ,70 years old.
Octogenarians are less likely to suffer from
diabetes mellitus or to be current smokers,
but in contrast to the younger population,
female sex is the predominant gender in this
age group.5,10 In this context, women are
known to be at higher risk for vascular
complications following minimally invasive
procedures. Compared to their male counter-
parts, women have a higher incidence of
comorbid diseases, are older, have smaller
vessel diameters, and have higher prevalenc-
es of hypertension, diabetes mellitus, hyper-
cholesterolemia, PAD, and unstable angi-
na.12,13
Secondly, octogenarians have a higher
incidence of arterial hypertension, which is
associated with a decrease in diastolic blood
pressure combined with an increase in
systolic blood pressure.14 This likely reflects
changes in the vessel wall due to natural
arterial aging, as arterial hypertension, es-
pecially isolated systolic hypertension,
indicates the extent of vessel wall stiff-
ness.14,15,16 A structural modification of the
arterial wall, involving increases in medial
thickness, collagen content, and collagen/
elastin ratio with a decrease in elastin
density, is associated with age. Decreased
elastin cross-linking and increased elastin
degradation in the extracellular matrix re-
duced compliance, leading to a stiffer arte-
rial wall.17,18,19,20 Several noninvasive mea-
surements indicate that the thickness of the
intimal and medial layers increase nearly 3-
fold between ages 20 and 90, even in the
absence of atherosclerosis.15,17
Thirdly, aging results in vascular calcifica-
tion within the medial and intimal layers, with
loss of elasticity. The underlying mechanism
is described as induction of osteogenesis
combined with loss of mineralization inhibi-
tors. Medial calcification increases pulse
pressure by contributing to total vascular
stiffness, and atherosclerotic calcification
may facilitate arterial dissection after balloon
injury.14,21 Fourthly, endothelium-dependent
vasodilation progressively declines with age.
Loss of prostacyclin and nitric oxide–derived
vasodilation within the aging vessel wall
ultimately leads to impaired endothelial func-
tion, with enhanced reactivity to vasocontric-
388 PERIPHERAL VASCULAR INTERVENTIONS IN OCTOGENARIANS
Dick et al.
tors.22 In summary, normal age-associated
changes in cardiovascular structure and func-
tion interact with pathophysiological disease
mechanisms and determine the risk for local
and systemic complications after endovascu-
lar procedures.
Unfortunately, we could not identify specif-
ic risk factors for complications within the
octogenarian population. Interestingly, the
use of access-site closure devices did not
improve the safety of the procedure. From the
present study, we are therefore unable to
speculate on preventive strategies to reduce
the risk for complications in octogenarians.
Nevertheless, in routine clinical practice, two
potentially important issues arise. Firstly, in
light of the relatively high complication rate,
indications to perform endovascular treat-
ment rather than conservative therapy should
be carefully considered, particularly in pa-
tients with intermittent claudication. Second-
ly, when interventions are performed, even in
the absence of other risk factors, octogenar-
ians have to be classified as high-risk patients
by virtue of their age alone.
Limitations
The study was purely observational, so
selection bias for or against endovascular
therapy rather than conservative medical or
surgical treatment thus may have played a
role. Furthermore, the study was not random-
ized with respect to the use of closure
devices. The proportion of patients receiving
a closure device was relatively small, so the
impact of closure devices on access site
complications in elderly patients remains to
be determined, and a potentially beneficial
effect cannot be excluded from the present
data.
Conclusion
Patients aged 80 years and older have a
dramatically increased risk for minor and,
particularly, for major complications after
peripheral vascular interventions. Develop-
ment of preventive strategies is urgently
required to improve the procedure safety in
this vulnerable population.
J ENDOVASC THER
2008;15:383–389
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