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Original Research |
1 Department of Radiology, Medical University Graz, University Hospital Graz,
Auenbruggerplatz 9, Graz A-8036, Austria.
2 Institute of Medical Informatics, Statistics and Documentation, Medical
University Graz, Graz, Austria.
3 Department of Angiology, Medical University Graz, University Hospital Graz,
Graz, Austria.
4 Central Institute of Roentgendiagnostics, LKH, Klagenfurt, Austria.
Received August 12, 2005;
accepted after revision December 7, 2005.
Address correspondence to H. A. Deutschmann
(hannes.deutschmann{at}meduni-graz.at).
Abstract
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SUBJECTS AND METHODS. Changes in quality of life were prospectively evaluated in 190 patients before and 1, 3, 6, and 12 months after treatment. Physical, emotional, and general health components were determined using the short-form (36 items) health survey (SF-36). Claudicant patients were compared with patients who had critical limb ischemia. The influence of the lesion location (iliac, femoropopliteal, or crural) restenosis, and additional interventions on quality of life were evaluated.
RESULTS. Six- and 12-month follow-up data were available for 136 and 103 patients, respectively. Significant improvements in quality of life were observed in most of the patients after the intervention. Many of the SF-36 scores decreased from the 6- to the 12-month follow-up but remained significantly higher than the score before the intervention. Reduction of bodily pain was the most evident effect of treatment. Claudicant patients seemed to benefit more from treatment than patients with critical limb ischemia. In terms of SF-36 scores, percutaneous transluminal angioplasty of the crural arteries was equally as effective as endoluminal revascularization of the iliac and femoropopliteal arteries and multilevel interventions were as effective as single-level interventions. The occurrence of a restenosis was significantly related to lower SF-36 scores, and restenosis not followed by a second intervention was associated with lower SF-36 scores.
CONCLUSION. Although there were several differences between the groups, significant improvements in quality of life up to 12 months after endoluminal therapy were observed in most patients.
Keywords: endoluminal therapy • extremities • interventional radiology • leg • peripheral vascular disease • stents
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The study end point was defined as either completion of the 12-month follow-up questionnaire or the need for the patient to undergo a surgical procedure interfering with the quality-of-life analysis. Patients were instructed to complete a questionnaire before an endovascular or surgical intervention was performed. The study was approved by the institutional review board, and informed consent was obtained from all patients.
Interventions
All interventions were performed using a standardized technique. Technical
success was defined as residual stenosis with less than 30% lumen reduction.
In the iliac arteries, in case of an unsatisfactory angioplasty result (i.e.,
residual stenosis of 3 30%, translesional residual mean pressure
gradient of > 10 mm Hg, or both), a stent was placed
[14]. In 38 (20%) patients,
interventions of the iliac arteries were performed. Of these, PTA was
performed in 19 (50%) patients, and PTA followed by selective placement of
several different stents in the other 19 (50%) patients. The following stents
were used: Smart stent (n = 13) (Cordis Endovascular), Palmaz
Corinthian stent (n = 2) (Cordis Endovascular), and Symphony
(n = 4) (Boston Scientific) stents.
To ensure proper expansion after insertion, all stents were dilated using a balloon. In 152 (80%) patients, PTA of the femoropopliteal arteries, crural arteries, or both were performed. There were 115 (60.5%) femoropopliteal interventions, seven (3.7%) isolated crural interventions, and 30 (15.8%) multilevel interventions (femoropopliteal and crural interventions, n = 25, iliac and femoropopliteal interventions, n = 5).
Clinical Follow-Up
In all patients, color duplex sonography examinations of the pelvic and
lower extremity arteries were performed before the intervention. In addition,
in many patients MR angiography performed before the intervention was
available. Furthermore, color duplex sonography examinations were scheduled 1,
3, 6, and 12 months after the intervention. In cases in which the patient's
clinical situation had deteriorated, conventional angiography or MR
angiography was performed to confirm the findings of color duplex sonography.
Careful assessment of changes in ischemic pain and the healing tendency of
ulcers was performed at each scheduled follow-up. Ischemic pain, healing
tendency of ulcers, or both were rated on a 3-point scale: 1 = improvement of
symptoms, 2 = no change, 3 = deterioration of symptoms. To be able to estimate
the clinical changes also in noncompliant patients who missed the scheduled
follow-up examination, the referring general practitioners, angiologists, or
vascular surgeons were contacted to obtain further information about changes
of medication, pulse status, and healing of ulcers. Furthermore, the pain-free
walking distance was assessed at each scheduled follow-up in all patients.
Quality of Life
For the assessment of health-related quality of life, the standard German
version (International Quality of Life Assessment [IQOLA] short-form health
survey with 36 items [SF-36], 1992) of the medical outcomes study form SF-36
was used [15,
16]. The German version of the
SF-36 survey was translated and validated according to the methodology
developed by the International Quality-of-Life Assessment Group
[17]. The SF-36 survey is
accepted as an entirely appropriate health assessment instrument in patients
with claudication [18,
19]. The self-administered
questionnaire is widely used in medical and health services research and
contains 36 items used to measure the following eight multiitem dimensions of
quality of life: physical functioning, social functioning, role limitations
due to physical problems, role limitations due to emotional problems, bodily
pain, mental health, vitality, and general health perceptions.
For each dimension, the item scores are coded, summed, and transformed to produce a score ranging from 0% (worst quality of life) to 100% (best possible quality of life measured by the questionnaire). All patients were asked to complete a copy of the questionnaire the day before the intervention and 1, 3, 6, and 12 months after the intervention. The first copy was collected by the study coordinator. The follow-up questionnaires were either collected in the course of a follow-up color duplex sonography examination or were sent by mail. Telephone calls were made to remind patients to complete the questionnaire in cases of missing questionnaires.
Statistical Analysis
Patients were grouped according to the PAD stage (stage IIa or IIb vs stage
III or IV) and the location of the treated lesion (iliac vs infrainguinal
arteries, single-level interventions vs multilevel interventions). Descriptive
statistics were used to calculate frequencies and percentages of baseline
characteristics of the patients. Baseline differences of metric variables
between the groups were assessed using the Student's t test.
Categoric variables were compared using the chi-square test. The Spearman's
rank correlation was used to assess significant relationships between baseline
characteristics and changes in quality-of-life scores. The Wilcoxon's signed
rank test for matched pairs was applied to assess changes in quality-of-life
scores before and at the time of the follow-up within each group. The
Mann-Whitney U test was used to test for differences in changes in
quality-of-life scores over time between the groups.
The effect sizes were calculated by dividing the difference between the mean pretreatment score and the mean posttreatment score by the SD of the mean pretreatment score. The use of effect sizes has been strongly recommended to enable changes in quality of life in different populations to be compared [20, 21]. Effect sizes of at least 0.2 were considered to be small and of no clinical significance, effect sizes of at least 0.5 were considered to be moderate and clinically significant, and effect sizes of 0.8 or greater were considered to be large and of clear clinical significance [22]. A two-sided p value of less than 0.05 was considered to be statistically significant. Statistical calculations were performed with the SPSS statistical package (version 10.0, 1999, SPSS).
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According to the study protocol, 10 (5.3%) patients dropped out during the study because an additional surgical intervention was needed. In four of these 10 patients, the initial intervention was not successful technically, with a residual stenosis of between 30% and 80%. In two, bypass surgery 4 days and 3 weeks after the initial intervention, respectively, was performed. In the two remaining patients, amputation was performed 2 months after the initial intervention in one and surgical bypass was performed 4 months after the initial intervention in the other. Follow-up questionnaires were obtained before the second intervention in these four patients.
In six of the 10 patients who dropped out because an additional surgical intervention was needed, the initial intervention was technically successful. In three of these patients, no follow-up questionnaires could be obtained before the second intervention: In one patient, occlusion of the distal aorta 2 days after iliac artery stent placement led to surgical thromboendarterectomy and consecutive bypass surgery; in a second patient, one stent occlusion in the common iliac artery 7 days after placement was treated with surgical thromboendarterectomy; and, in the third patient, amputation of the lower leg was needed 1 month after the initial intervention. In three other patients, in whom bypass surgery was performed 1 month (n = 1, contralateral) and 3 months (n = 2, ipsilateral and contralateral) after the initial intervention, the 1- and 3-month follow-up questionnaires were available.
Patients
The baseline characteristics of 190 patients with PAD are given in Tables
1 and
2. Summing the scores for the
eight dimensions assessed using the SF-36 survey for all 190 patients, we
found that there was a significant increase in the scores from before the
intervention to the 1-month follow-up for each of the dimensions except social
functioning and general health perception
(Fig. 1). The effect size was
0.98 SD (p < 0.001) for physical functioning, 0.79 SD (p
< 0.001) for role limitations due to physical problems, 0.16 SD (p
= 0.03) for role limitations due to emotional problems, 0.63 SD (p
< 0.001) for vitality, 0.51 SD (p < 0.001) for mental health,
0.17 SD (p = 0.07) for social functioning, 1.46 SD (p <
0.001) for bodily pain, and -0.14 SD (p = 0.23) for general health
perception (Fig. 2). At the 3-
and 6-month follow-ups, the scores remained unchanged, but a decrease in the
scores from the 6- to the 12-month follow-ups was observed for all dimensions
except role limitations due to emotional problems, social functioning, and
general health perception (Figs.
1 and
2). This trend was similar for
all groups but was not statistically significant.
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Claudicant patients (PAD stages IIa and IIb) were significantly younger than patients with critical limb ischemia (PAD stages III and IV: mean age, 66.6 ± 10.7 [SD] vs 71.2 ± 9.5 years, respectively; p < 0.005) and reported a significantly longer pain-free walking distance (141 ± 153 vs 64 ± 55 m, p < 0.001, Table 1). The prevalence of coronary heart disease (25/130 vs 25/60, p < 0.001) and diabetes mellitus (39/130 vs 31/60, p = 0.006) was significantly lower in claudicant patients than in patients with critical limb ischemia (Table 1). Compared with claudicant patients, patients with critical limb ischemia (PAD stages III and IV) showed significantly lower scores for physical functioning (mean score for patients with critical limb ischemia vs mean score for claudicant patients, 24.8 vs 39.9; p < 0.001), role limitations due to physical problems (5.6 vs 17.1, p = 0.01), role limitations due to emotional problems (28.5 vs 41.8, p = 0.003), vitality (28.1 vs 38.3, p < 0.001), and bodily pain (13.9 vs 23.4, p = 0.01) at baseline (Fig. 3).
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No difference in terms of SF-36 scores was found between patients who underwent single-level interventions and those who underwent with multilevel interventions.
Interventions
The mean grade of stenosis for all lesions was 84.4% ± 11.1%. The
mean length of occlusion was 0.98 ± 6.4 cm. Of 190 interventions, 168
(88.4%) were considered technically successful (i.e., residual stenosis of
< 30%). In 24 (14.3%) of these patients, a second intervention due to
restenosis or reocclusion was performed. Nine (4.8%) of 190 interventions were
only partially successful (i.e., one of multiple treated lesions showed a
residual stenosis of 3 30%). In one (11.1%) of these patients, a
second intervention was performed. Thirteen (6.8%) of 190 interventions were
considered technically not successful (i.e., residual stenosis of > 30%:
iliac arteries, n = 2, femoropopliteal arteries, n = 9,
crural arteries, n = 2). In seven (53.8%) of these patients, a second
intervention was performed.
The number of reinterventions in patients with technically not successful
interventions was significantly higher than in patients with technically
successful interventions (
2 = 13.18, p = 0.002). The
time to reintervention was significantly shorter in patients with not
successful interventions than in patients with successful interventions (3.4
± 1.1 vs 5.7 ± 3.2 months, respectively; p = 0.08).
Because of the different grades of residual stenosis, the combination of
either not successful or only partially successful intervention, and the small
number of patients, a statistical analysis of possible differences in quality
of life between patients with technically not successful or only partially
successful interventions and patients with successful interventions was not
performed.
We found no significant differences in SF-36 scores among iliac, femoropopliteal, and crural interventions. There was no significant difference between patients with single-level interventions (n = 160) and patients with multilevel interventions (n = 30). There was no significant correlation between the grade of stenosis at the time of the intervention and changes in quality of life as assessed by Spearman's correlation.
Compared with patients with technically successful primary interventions,
patients with residual stenosis of 
30% and no subsequent intervention
(18/25) showed significantly lower scores for bodily pain (effect size, 0.44
vs 1.6 SD, respectively; p = 0.02) and physical functioning (0.87 vs
0.99 SD, p = 0.03) at 1 month, for bodily pain (0.49 vs 1.6 SD,
p = 0.04) at 3 months, and for bodily pain (0.35 vs 1.4 SD,
p = 0.04) and social functioning (-0.35 vs 0.15 SD, p =
0.007) at 6 months.
Patients with restenosis followed by a successful secondary intervention showed no differences in SF-36 scores at 1-, 3-, and 6-month follow-up compared with patients who underwent a primary intervention that was successful. Only at the 12-month follow-up were lower scores observed for vitality (effect size, 0.01 vs 0.7 SD, p = 0.02), mental health (0.06 vs 0.65 SD, p = 0.03), and general health perception (-1.4 vs -0.11 SD, p < 0.001).
Patients in whom a significant stenosis was diagnosed during follow-up and who had no successful secondary intervention showed significantly lower scores for physical functioning (effect size, 0.47 vs 1.07 SD, respectively; p = 0.03), vitality (effect size, 0.09 vs 0.65 SD; p = 0.02), bodily pain (1.4 vs 2.1 SD, p =0.02), and general health perception (-0.01 vs -0.87, p = 0.04) at the 1-month follow-up compared with patients without restenosis. Furthermore, lower scores for bodily pain (1.4 vs 2.5 SD, p = 0.04) and general health perception (-1.4 vs -0.2 SD, p = 0.007) were observed at the 3-month follow-up. At 6 months, lower scores for physical functioning (0.2 vs 0.8 SD, p =0.04) and social functioning (-0.2 vs 0.14 SD, p = 0.007) and at 12 months for physical functioning (-0.4 vs 0.8 SD, p = 0.04), vitality (-0.6 vs 0.7 SD, p < 0.01), social functioning (-0.8 vs 0.16 SD, p < 0.01), and bodily pain (1.2 vs 2.1 SD, p = 0.04) were observed.
Clinical Follow-Up
A statistically significant relation between deterioration of the symptoms
associated with PAD and the quality-of-life scores was found. Patients who
reported a deterioration in the clinical symptoms showed significantly lower
scores for all SF-36 domains at 1, 3, 6, and 12 months (p < 0.05)
except role limitations due to emotional problems and social functioning at 12
months. Furthermore, the walking distance was significantly correlated to
SF-36 scores at 1, 3, 6, and 12 months, except for role limitations due to
emotional problems at 6 and 12 months (range of Spearman's correlation
coefficients, 0.34-0.74; p < 0.001). Follow-up examinations on
color-coded duplex sonography, catheter angiography, or MR angiography were
available in 93 (49%) patients. In 56 (60.2%) of the 93 patients (29.5% of all
patients), a significant stenosis (i.e., lumen reduction 3 30%) was
detected during follow-up: 43 restenoses at the site of the intervention and
five ipsilateral and eight contralateral de novo lesions. Endoluminal
treatment was performed in 35 (62.5%) of these patients. The site of the
reintervention was the site of the initial intervention in 24 patients, the
ipsilateral leg in four patients, and the contralateral leg in seven patients.
The mean time from the initial intervention to the reintervention was 5.8
± 3.3 months.
The occurrence of a restenosis was related to lower scores for physical functioning (p < 0.001), role limitations due to emotional problems (p < 0.04), vitality (p = 0.0014), mental health (p = 0.006), bodily pain (p = 0.002), and general health perception (p = 0.0013) at 1 month. At 3 months, lower scores were observed for vitality (p = 0.02), bodily pain (p = 0.047), and general health perception (p = 0.0012). At 6 months, lower scores were observed for role limitations due to emotional problems (p = 0.03), vitality (p = 0.006), bodily pain (p = 0.002), and general health perception (p = 0.009). At 12 months, lower scores were observed for physical functioning (p = 0.04), vitality (p = 0.017), mental health (p = 0.025), social functioning (p = 0.01), bodily pain (p = 0.005), and general health perception (p = 0.011).
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A positive effect on the quality of life of claudicant patients is also reported for conservative treatment methods such as exercise therapy [23]. However, in a cost-effectiveness analysis including different treatment options, PTA proved to be more cost-effective than exercise alone and the cost-effectiveness ratio of PTA was within the generally accepted range [24]. Given these results and considering the results of the current study, the higher costs of PTA compared with conservative treatment seem to be justified.
The highest impact of endoluminal treatment on quality-of-life scores was observed for the physical components of the SF-36—namely, physical functioning, role limitations due to physical problems, and bodily pain. The effect sizes for these scales were higher than the effect sizes for role limitations due to emotional problems, mental health, and vitality. Similar results were observed for all groups and for the immediate postinterventional follow-up and up to 12 months. These results are in line with those of previous studies assessing the influence of PTA or of prostaglandin E1 administration on quality of life [7, 13, 25]. A possible explanation may be that the main effect of the revascularization is the reduction of pain and a subsequent increase of the pain-free walking distance. Furthermore, emotional components are influenced by significant comorbidity such as coronary heart disease and diabetes mellitus, neither of which is influenced by the endoluminal therapy [26, 27].
In this study, not only claudicant patients but also patients with critical limb ischemia were included. At baseline, claudicant patients were significantly younger in age, reported a longer pain-free walking distance, and had a lower prevalence of coronary heart disease and diabetes mellitus than patients with critical limb ischemia (Table 1). Furthermore, claudicant patients showed significantly higher scores for several SF-36 scales at baseline. Similar results were observed by Chetter et al. [28].
To exclude possible influences of differences at baseline, we included an objective measurement of the true changes of quality-of-life scores: the effect size. This method of measuring changes in quality-of-life scores before and after treatment or during the follow-up period was proposed by the investigators of several studies to ensure comparability among different investigations [20, 21, 29]. Within the first 6 months after revascularization, claudicant patients showed significantly higher scores and effect sizes for several SF-36 dimensions than patients with critical limb ischemia. At the 12-month follow-up, no significant differences between the two groups could be observed. This may be due to the reduced health condition of many of the patients with critical limb ischemia, which was caused, to a great extent, by factors of comorbidity that are not influenced by endoluminal therapy [26, 27]. These results suggest that claudicant patients especially may benefit from endoluminal therapy and that the most pronounced effect of treatment can be expected within the immediate postinterventional period.
The efficacy of endoluminal treatment did not seem to be determined by the distribution of arteriosclerotic disease. There were no significant differences in SF-36 scores between patients with lesions of the iliac arteries, most of whom were heavy smokers, and patients with infrainguinal lesions, most of whom were diabetic. Furthermore, no significant differences were found between interventions of the crural arteries compared with interventions of the femoropopliteal or iliac arteries. Therefore, balloon dilatation of a single stenosis of the crural arteries seems to be equally effective in terms of SF-36 scores compared with PTA of the femoropopliteal and iliac arteries. However, a prospective investigation in patients with crural artery stenosis comparing a treatment versus a nontreatment group remains to be performed.
We did not observe significant differences of SF-36 scores between patients who underwent single-level interventions compared with those who underwent multilevel interventions. This finding suggests that the risk of developing a restenosis or reocclusion is not increased for patients in whom more than one vascular region is affected compared with patients with single lesions. However, we did not assess whether untreated lesions were present in patients who underwent single-level interventions. Therefore, conclusions about the usefulness of multilevel interventions should be drawn with reservation.
In this study, significantly lower values for certain SF-36 scores were observed if failed technical success of the primary intervention or detection of a significant restenosis during follow-up was not followed by a successful secondary intervention. This may underline the importance of achieving the lowest possible grade of residual stenosis or, if not possible, of performing secondary interventions to allow a better quality of life.
Several limitations of the study should be considered. First, follow-up examinations with color-coded duplex sonography, MR angiography, or catheter angiography could be obtained in only 93 (49%) patients. However, in these patients, the occurrence of a restenosis was related to lower scores for several of the SF-36 domains at 1, 3, 6, and 12 months. Second, a high correlation of SF-36 domains with clinical symptoms has been reported [30]. Therefore, careful assessment of changes in symptoms associated with PAD (e.g., pain, healing of ulcers) was performed at each scheduled follow-up. The results suggest that a deterioration in clinical symptoms associated with PAD may be related to lower scores for several SF-36 domains at 1, 3, 6, and 12 months. However, the ankle-brachial index was assessed in only a small number of patients. Furthermore, no validated score for assessing pain and no standardized criteria for measuring the healing of ulcers (e.g., largest diameter or deepest portion) were applied. Third, changes of SF-36 scores may be attributed to placebo effects. However, because the most marked changes of SF-36 scores were observed for physical functioning, role limitations due to physical problems, and bodily pain and only small changes were observed for role limitations due to emotional problems and mental health, a major bias due to placebo effects seems unlikely.
In conclusion, significant improvements in quality of life were observed in most of the patients after endoluminal therapy. Although there were several differences between the groups, immediate and lasting increases of SF-36 scores up to 12 months after the intervention could be observed in most of the patients. However, prospective randomized trials comparing endoluminal treatment with conservative treatment are necessary to further elucidate the benefit of endoluminal therapy with regard to health-related quality of life.
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