One-year prospective quality-of-life outcomes in patients treated with angioplasty for symptomatic peripheral arterial disease
Article Outline
Background
Despite lower reported patency rates than open bypass, percutaneous transluminal angioplasty (PTA) may result in symptom relief, limb salvage, maintenance of ambulation and independent living, and overall improved quality of life. The goal of this study was to prospectively assess quality of life and functional outcomes after angioplasty and stenting in patients with chronic leg ischemia.
Methods
From August to December 2002, 84 patients with 118 chronically ischemic limbs underwent PTA with or without stenting as part of an ongoing prospective project performed to examine management of symptomatic peripheral arterial disease. All patients completed a preprocedure health questionnaire (Short Form 36) to provide adequate baseline data. Each patient was followed up every 3 months after treatment for 1 year to determine traditional outcomes of arterial patency, limb salvage, survival and amputation-free survival, and functional outcomes assessed according to improvement in quality of life, maintenance of ambulatory status, and maintenance of independent living status. The entire cohort was analyzed, as were subgroups of patients with lifestyle-limiting claudication and those with critical limb ischemia. Outcomes were analyzed by using Kaplan-Meier life-table analysis, the log-rank test for survival curves, and the one-sample t test. A Cox proportional hazard model was used to determine whether presentation and level of disease were independent predictors of outcome.
Results
Of the 84 patients, 54 (64.3%) were treated for claudication (34 aortoiliac occlusive disease and 20 infrainguinal disease), and 30 (35.7%) were treated for critical limb ischemia (11 aortoiliac occlusive disease and 19 infrainguinal disease). One-year results for the 54 patients with claudication were as follows: primary patency, 78.5%; limb salvage, 100%; amputation-free survival, 96.3%; survival, 96.3%; maintenance of ambulation status, 100%; and maintenance of independence, 100%. There was statistical improvement in all physical function categories, including physical function (29.4 ± 8.9 vs 37.1 ± 11.3; P < .0001), role-physical (32.5 ± 11.3 vs 39.5 ± 13.0; P = .0001), bodily pain (35.8 ± 8.5 vs 42.9 ± 10.9; P < .0001), and aggregate physical scoring (31.1 ± 9.7 vs 38.1 ± 11.5; P < .0001). One-year results for the 30 patients with critical limb ischemia were as follows: primary patency, 35.2%; limb salvage, 77.2%; amputation-free survival, 50.0%; survival, 60.0%; maintenance of ambulation status, 75.8%; and maintenance of independence, 92.8%. There was statistical improvement in bodily pain resolution (35.3 ± 12.0 vs 46.6 ± 12.0; P = .0009). Cox models with hazard ratios (HRs) revealed that presentation was a significant predictor for outcomes of primary patency (HR, 4.2; P= .0002), secondary patency (HR, 6.0; P < .0001), limb salvage (HR, 20.2; P = .0047), survival (HR, 10.9; P = .0002), and amputation-free survival (HR, 11.2; P < .0001). Conversely, the level of disease was predictive of outcome only for primary patency (HR, 1.8; P = .00289).
Conclusions
Despite inferior reconstruction patency rates when compared with the historical results of open bypass, PTA provides excellent functional outcomes with good patient satisfaction, especially for treating claudication. These findings support a more liberal use of PTA intervention for patients with vasculogenic claudication.
Attitudes regarding the appropriate treatment of peripheral atherosclerosis have evolved significantly over the past 20 years. Originally, vascular surgeons relegated angioplasty to the radiologists and considered the therapy second rate because of intrinsic technical limitations and inferior patency rates when compared with open surgery. As vascular surgeons have learned endovascular skills, they have become agreeable to peripheral angioplasty as a tool to treat lower extremity ischemia. Similarly, attitudes regarding the treatment of chronic lower extremity ischemia have changed as well. Stimulated by recently published studies demonstrating the functional benefit of early intervention on claudicants1 and the occasional futility of treating desperate cases of limb salvage,2 our treatment tendencies have evolved accordingly. Arguably, today our attitude toward the aggressive interventional treatment of claudication is at an all-time peak, and the primary interventional treatment of choice is percutaneous transluminal angioplasty (PTA).
It has long been accepted that results after PTA yield inferior patency but lower perioperative mortality when compared with open bypass.3 Fueled by our changing attitudes, we have adopted a policy of liberal PTA use in claudicants with observations that it is initially beneficial in most cases, it is safe, and it does little harm. This observation has forced us to re-examine our end points of success. With increasing acceptance, most now appreciate that improved quality of life, enhanced patient satisfaction, maintenance of ambulation, and maintenance of independence supersede arterial reconstruction patency as the most important determinants of success. Despite this, there is a paucity of objective data to support this belief. The purpose of this prospective study, therefore, was to objectively assess quality of life and functional outcomes after PTA in patients with lower extremity peripheral arterial disease (PAD).
Methods
From August 1, 2002, to December 31, 2002, all patients participating in the LEGS (Lower Extremity Grading System) prospective study protocol at our institution who underwent PTA for the treatment of symptomatic lower extremity PAD were assessed for quality-of-life and functional outcome changes as a result of their intervention. We identified 84 patients and 118 limbs treated by PTA for claudication (54 [64.3%] patients and 78 [66.1%] limbs) or for critical limb ischemia (30 [35.7%] patients and 40 [33.9%] limbs). Interventions included 44 femoral-popliteal or tibial angioplasty procedures (11 with stent) and 74 aortoiliac angioplasty procedures (73 with stent). The 44 infrainguinal interventions consisted of 29 SFA, 3 popliteal, 5 tibial, and 7 multilevel angioplasties.
The LEGS treatment algorithm (Fig) was used to direct therapy for all patients presenting for the invasive management of symptomatic lower extremity PAD during this time.4 This study represents a population of patients who had experienced medical management failure and met clinical indications for intervention. Medical management typically consists of smoking cessation counseling and a 3- to 12-month trial of both supervised and unsupervised walking exercise. The use of this treatment algorithm, which was studied under institutional review board approval with the results of treatment being previously reported,5, 6 typically designated claudicants and patients with critical limb ischemia and short segment arterial stenoses to PTA. This study population (mean age, 64.5 ± 11.2 years; median, 65.5 years; range, 38-84 years) consisted of 56 men and 28 women (74 white and 10 black) who had the following comorbidities: diabetes mellitus (44.1%), a history of cigarette smoking (85.7%), and severe coronary artery disease (16.7%), as assessed by the LEGS score outcomes study.5
Fig.
Percutaneous transluminal angioplasty was offered to patients who presented with operative indications for symptomatic peripheral arterial disease of the lower extremities on the basis of an aggregate score of 10 to 19 by using the LEGS (Lower Extremity Grading System) score, shown below.
Each patient was assessed for baseline ambulatory status and resident living status. Also, each patient completed an Short Form 36 (SF-36) health assessment survey. For the purpose of the study, ambulatory status was classified as being ambulatory, ambulatory but homebound, nonambulatory/transfer only, or nonambulatory/bedridden. Living status was classified as independent at home, living in an assisted-living facility (a communal facility where independence for its residents is allowed but meals are provided and assistance is given as needed), or living in a nursing home (defined as a facility where all daily functions are assisted by personnel at the institution).
The SF-36 health assessment survey offers patients a chance to make an informal estimate of their own overall health and well-being. The survey measures 10 areas of health: physical function, role-physical, bodily pain, general health, vitality, social function, role-emotional, mental health, an aggregate physical health score, and an aggregate mental health score.7
Patients were followed up every 3 months for 1 year. The SF-36 survey was repeated at 6 and 12 months. Outcome measures included arterial reconstruction patency (determined by thrombosis of the treated vessel as detected at physical examination and confirmed at duplex ultrasound scanning or by deterioration to preinterventional ankle-brachial index), limb salvage, mortality and amputation-free survival rates, maintenance of ambulatory status (a change in ambulation status was defined as a deleterious change in the ambulation category listed previously), maintenance of independent living status (a change in independent living status was defined as a deleterious change in the independent living category listed previously), and a change in the SF-36 health survey score.
Arterial reconstruction patency, limb salvage, survival, amputation-free survival, maintenance of ambulation, and maintenance of independence were measured by using Kaplan-Meier life-table analysis, and associated survival curves were compared by using the log-rank test. Preprocedure SF-36 scores were compared with postprocedure SF-36 scores by using the one-sample t test. A Cox proportional hazard model was used, when appropriate, to measure the ability of a specific variable to predict outcome.
Results
One-year follow-up was completed for all 118 limbs treated. Primary patency, secondary patency, and limb salvage are shown in Table I for the entire cohort and segregated by treatment indication (claudication or critical limb ischemia). Of the 118 limbs treated, there were no early (<30 days; in-hospital) deaths or major complications; however, there were 11 early primary failures. Four of these failed PTAs were salvaged by additional PTA for secondary patency. Primary and secondary patency rates were 73.2% and 87.7%, respectively, at 6 months and 64.7% and 83.8% at 1 year. As can be seen in Table I, patients with critical limb ischemia had statistically significantly inferior patency as compared with patients with claudication. Seven patients lost a total of eight limbs at 1 year for a Kaplan-Meier limb salvage rate of 93.4%. There was no limb loss in the claudication group—a difference that was statistically significant. Three of the eight patients requiring major limb amputation were able to salvage ambulation with the use of a prosthetic limb.
Table I. Technical outcomes at 6 months and 1 year
| Variable | No. Limbs | Primary patency (%) | Secondary patency (%) | Limb salvage (%) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6 mo | 95% CI | 1 y | 95% CI | 6 mo | 95% CI | 1 y | 95% CI | 6 mo | 95% CI | 1 y | 95% CI | ||
| Overall | 118 | 73.2 | 64.9-81.5 | 64.7 | 55.7-73.6 | 87.7 | 81.6-93.7 | 83.8 | 77.0-90.7 | 95.4 | 91.5-99.3 | 93.4 | 88.7-98.1 |
| Claudication | 78 | 87.9 | 80.5-95.3 | 78.5 | 69.1-87.8 | 97.3 | 93.7-100.0 | 94.6 | 89.5-99.7 | 100 | — | 100 | — |
| CLI | 40 | 42.3 | 25.4-59.1 | 35.2 | 18.6-51.8 | 67.9 | 52.6-83.1 | 61.1 | 44.7-77.5 | 85.0 | 72.6-97.3 | 77.2 | 62.0-92.4 |
Survival and amputation-free survival for the entire series and by indication for treatment are shown in Table II. Patients experienced an 81.4% and a 79.7% amputation-free survival rate at 6 months and 1 year, respectively. At 1 year, 14 patients, 12 in the critical limb ischemia group, died, for a Kaplan-Meier survival rate of 83.3%. Survival and amputation-free survival were significantly lower in the critical limb ischemia group.
Table II. Analysis of survival outcomes for PTA at 6 months and 1 year
| Variable | No. Limbs | Survival (%) | Amputation-free survival (%) | ||||||
|---|---|---|---|---|---|---|---|---|---|
| 6 mo | 95% CI | 1 y | 95% CI | 6 mo | 95% CI | 1 y | 95% CI | ||
| Overall | 84 | 83.3 | 75.4-91.3 | 83.3 | 75.4-91.3 | 81.4 | 74.3-88.4 | 79.7 | 72.4-86.9 |
| Claudication | 54 | 96.3 | 91.3-100.0 | 96.3 | 91.3-100.0 | 96.3 | 90.0-99.8 | 96.3 | 90.0-99.8 |
| CLI | 30 | 60.0 | 42.5-77.5 | 60.0 | 42.5-77.5 | 55.0 | 39.6-70.4 | 50.0 | 34.5-65.5 |
Maintenance of ambulatory status and maintenance of living status for the entire series and by indication for treatment are shown in Table III. Of the 84 patients, only 5 patients experienced a decline in their preprocedure ambulatory ability at 6 months, and only 6 patients experienced a decline at 1 year, for rates of 93.7% and 92.3%, respectively. There were no nursing home patients before the procedure, and there were only two patients who lived in an assisted living facility at the time of presentation. The remaining 82 patients lived at home, either alone or with family members. Only three patients experienced a change in preprocedure living status. Two of these patients were admitted to a nursing home shortly after discharge from the hospital after successful endovascular procedures, and a third was admitted to a nursing home after bilateral above-knee amputations. Each of these three patients was in the group with critical limb ischemia. Kaplan-Meier life-table analysis revealed a 6-month maintenance-of-living-status rate of 97.5% at 6 months and 96.1% at 1 year. All patients in the claudication group maintained their ambulatory status and their independent living status at 1 year, compared with 75.8% and 87.3%, respectively, for the critical limb ischemia group, a difference that was statistically significant.
Table III. Analysis of functional outcomes for PTA at 6 months and 1 year
| Variable | No. Limbs | Ambulation maintenance (%) | Independence maintenance (%) | ||||||
|---|---|---|---|---|---|---|---|---|---|
| 6 mo | 95% CI | 1 y | 95% CI | 6 mo | 95% CI | 1 y | 95% CI | ||
| Overall | 84 | 97.3 | 88.3-99.1 | 92.3 | 86.4-98.2 | 97.5 | 94.1-100.0 | 96.1 | 91.8-100.0 |
| Claudication | 54 | 100 | — | 100 | — | 100 | — | 100 | — |
| CLI | 30 | 80.8 | 65.5-96.2 | 75.8 | 58.5-93.1 | 92.8 | 83.2-100.0 | 87.3 | 73.5-100.0 |
When looking at data by the level of disease treated, aortoiliac disease fared better than infrainguinal disease overall. The primary and secondary patency rates at 1 year for aortoiliac intervention vs infrainguinal intervention were 67.6% and 84.5% vs 45.6% and 78.2%, respectively. Limb salvage and amputation-free survival rates at 1 year for aortoiliac intervention vs infrainguinal intervention were 97% and 88.9% vs 85.4% and 64.1%, respectively. Although these differences were both statistically and clinically significant, the indication for intervention (claudication vs critical limb ischemia) was more predictive of eventual outcome than the level of disease treated. With a Cox proportional hazard model, the level of disease was found to be a statistically significant independent predictor of outcome for only one parameter: primary patency (hazard ratio [HR], 1.8; P = .0289). In contrast, the indication for intervention was found to be a statistically significant independent predictor of outcome for death (HR, 10.9; P = .002), amputation-free survival (HR, 11.2; P = .0001), primary patency (HR, 4.2; P = .002), secondary patency (HR, 6.0; P = .0001), and limb salvage (HR, 20.2; P = .0047). When considering the level of disease treated and the indication for the procedure, the best performers were claudicants receiving PTA of the aortoiliac arteries (primary patency, 78.9%; secondary patency, 92.3%; limb salvage, 100%; survival, 97.1%; amputation-free survival, 97.1%; maintenance of ambulation, 100%; and maintenance of independent living status, 100%). The worst performers were patients with critical limb ischemia receiving PTA of the infrainguinal vessels (primary patency, 23.1%; secondary patency, 56%; limb salvage, 65.6%; survival, 52.6%; amputation-free survival, 42.1%; maintenance of ambulation, 69.2%; and maintenance of independent living status, 93.8%).
A total of 70 patients received a pretreatment, 6-month, and 1-year SF-36 survey. When considering the entire group, there was statistically significant improvement in all categories except general health and role-emotional at 6 months. At 1 year, all physical health categories showed statistically significant improvement, but no emotional or mental health category was statistically improved. A comparison of pretreatment, 6-month, and 1-year SF-36 health assessment surveys for patients with claudication vs critical limb ischemia is shown in Table IV. Patients with claudication significantly improved all outcome measures with the exception of general health at 6 months and general health, vitality, role-emotional, mental health, and aggregate mental health at 1 year. In contrast, there was no statistically significant improvement from pretreatment SF-36 assessment in patients with critical limb ischemia at 1 year in any category except bodily pain and role-emotional. Likewise, a comparison of pretreatment, 6-month, and 1-year SF-36 health assessment surveys for patients with aortoiliac occlusive disease vs infrainguinal disease is shown in Table V. Patients with aortoiliac occlusive disease significantly improved all outcome measures at 1 year with the exception of general health, role-emotional, mental health, and aggregate mental health. Patients with infrainguinal disease improved at 1 year in physical function, bodily pain, and aggregate physical health.
Table IV. Results of the Short Form 36 health survey before and after endovascular intervention for claudication and critical limb ischemia
| Variable | Before treatment | 6-mo follow-up | 1-y follow-up | Difference at 1 y | P value |
|---|---|---|---|---|---|
| Claudication (n = 52) | |||||
 Physical function | 29.4±8.9 | 37.6±13.1⁎ | 37.1±11.3 | +9.2 | <.0001⁎ |
| Role-physical | 32.5±11.3 | 38.9±11.9⁎ | 39.5±13.0 | +7.0 | .0001⁎ |
| Bodily pain | 35.8±8.5 | 44.0±10.8⁎ | 42.9±10.9 | +7.2 | <.0001⁎ |
| General health | 41.3±11.5 | 42.4±11.4 | 41.2±11.9 | −0.2 | .91 |
| Vitality | 42.7±13.1 | 49.9±12.6⁎ | 45.7±15.0 | +3.0 | .18 |
| Social function | 39.8±15.2 | 45.9±11.2⁎ | 46.9±12.9 | +7.1 | .0015⁎ |
| Role-emotional | 40.8±16.9 | 46.1±12.4⁎ | 43.0±15.6 | +2.2 | .38 |
| Mental health | 55±15.1 | 51.3±11.3⁎ | 48.8±14.8 | +3.3 | .07 |
| Agg physical | 31.1±9.7 | 37.2±13.5⁎ | 38.1±11.5 | +7.0 | <.0001⁎ |
| Agg mental | 49.0±15.2 | 53.9±9.8⁎ | 50.8±13.2 | +1.8 | .38 |
| Critical limb ischemia (n = 18) | |||||
| Physical function | 27.2±10.3 | 29.0±13.3 | 30.1±14.3 | +2.9 | .30 |
| Role-physical | 30.2±14.0 | 33.7±14.3 | 30.9±13.3 | +0.7 | .85 |
| Bodily pain | 35.3±12.0 | 42.4±11.5⁎ | 46.6±12.0 | +11.2 | .0009⁎ |
| General health | 36.6±9.2 | 36.3±9.7 | 38.0±10.7 | +1.4 | .57 |
| Vitality | 41.1±13.2 | 44.3±12.0 | 42.9±14.9 | +1.7 | .56 |
| Social function | 35.9±16.0 | 39.3±15.3 | 40.5±14.1 | +4.5 | .19 |
| Role-emotional | 42.9±16.5 | 40.3±18.2 | 32.8±18.8 | −10.2 | .042⁎ |
| Mental health | 42.8±13.1 | 46.1±12.6 | 40.3±15.6 | −2.5 | .51 |
| Agg physical | 27.6±13.9 | 30.5±12.5 | 32.1±13.4 | +4.6 | .17 |
| Agg mental | 49.0±11.6 | 49.9±12.1 | 43.9±15.3 | −5.0 | .15 |
⁎ Statistically significant (P< .05). |
Table V. Results of the Short Form 36 health survey before and after endovascular intervention for aortoiliac disease and infrainguinal disease
| Variable | Before treatment | 6-mo follow-up | 1-y follow-up | Difference at 1 y | P value |
|---|---|---|---|---|---|
| Aortoiliac (n = 42) | |||||
| Physical function | 29.4±8.9 | 38.8±12.6⁎ | 37.1±11.3 | +7.7 | <.0001⁎ |
| Role-physical | 32.5±11.3 | 39.3±12.0⁎ | 39.2±12.8 | +6.7 | .0005⁎ |
| Bodily pain | 35.8±9.1 | 44.2±11.2⁎ | 46.0±9.4 | +10.2 | <.0001⁎ |
| General health | 40.7±11.5 | 42.2±11.7 | 39.6±11.7 | −1.1 | .54 |
| Vitality | 40.2±13.6 | 49.9±13.2⁎ | 45.9±114.0 | +5.7 | .0180⁎ |
| Social function | 38.0±15.3 | 45.4±11.8⁎ | 46.0±12.3 | +8.0 | .0008⁎ |
| Role-emotional | 40.7±16.7 | 46.9±12.3 | 42.6±15.5 | +1.8 | .59 |
| Mental health | 44.7±14.7 | 51.2±10.9⁎ | 48.0±13.5 | +3.3 | .14 |
| Agg physical | 31.0±10.4 | 37.7±13.2⁎ | 37.7±12.2 | +6.7 | .0002⁎ |
| Agg mental | 47.6±14.8 | 53.8±10.0⁎ | 50.4±12.0 | +2.8 | .28 |
| Infrainguinal (n = 28) | |||||
| Physical function | 28.1±9.8 | 30.3±13.6 | 33.4±13.3 | +5.3 | .0195⁎ |
| Role physical | 31.1±13.1 | 35.1±113.5 | 335.4±13.4 | +4.3 | .14 |
| Bodily pain | 35.4±10.0 | 42.8±10.7⁎ | 41.5±11.8 | +6.1 | .0161⁎ |
| General health | 39.3±10.6 | 38.8±10.9 | 42.5±9.6 | +3.2 | .10 |
| Vitality | 45.4±11.7 | 46.2±11.6 | 45.1±14.8 | −0.3 | .91 |
| Social function | 39.9±15.7 | 42.4±13.6 | 45.3±12.7 | +5.5 | .08 |
| Role-emotional | 42.3±17.1 | 41.2±16.4 | 39.2±17.3 | −3.1 | .31 |
| Mental health | 45.0±14.7 | 48.0±13.0 | 46.0±15.0 | +1.0 | .69 |
| Agg physical | 28.9±11.9 | 32.1±13.5 | 35.3±11.7 | +6.3 | .0210⁎ |
| Agg mental | 51.0±13.5 | 51.5±11.1 | 48.8±14.0 | −2.2 | .40 |
⁎ Statistically significant (P< .05). |
Discussion
In the hands of appropriately trained proceduralists, PTA has become a reliable technical alternative to surgical bypass in many cases. Early technical success for most lesions treated exceeds 90%, and periprocedural morbidity is low.8 However, most vascular surgeons consider intermediate and long-term results to be inferior to those with open bypass. Although this may be true when arterial reconstruction patency is measured, it may not be the case when functional outcomes (such as maintenance of independence) are measured or when subjective quality-of-life outcomes (such as patient satisfaction) are used. Objective data in the latter category are sparse.
The purpose of this study was to investigate functional and quality-of-life outcomes in a group of patients undergoing endovascular treatment for claudication and critical limb ischemia. To do this, we prospectively followed up 84 patients who underwent PTA for symptomatic lower extremity PAD: 54 for claudication and 30 for critical limb ischemia. In addition to the traditional measures of patency, survival, and limb salvage, we assessed maintenance of ambulatory status, maintenance of independent living status, and subjective well-being by using the SF-36 health assessment survey before and after intervention. We were able to achieve acceptable technical success, including an 83.8% 1-year arterial reconstruction secondary patency rate, an overall 93.4% limb salvage rate, an 83.3% survival rate, and nearly an 80% amputation-free survival rate—findings comparable to those of many previously reported studies.3, 8 Findings unique to this study included a notable 1-year maintenance-of-ambulation rate of 92.3% and a maintenance-of-independent-living-status rate of 96.1%. Also, SF-36 health assessment significantly improved for the overall series in nearly every category at 6 months and for nearly all physical status measures at 1 year. General health assessment and most of the emotional assessment categories were unchanged at 1 year for the overall group.
As with traditional outcomes (patency and limb salvage), quality-of-life assessment was significantly affected by the indication for treatment. Claudicants consistently outperformed patients undergoing treatment for critical limb ischemia in nearly every SF-36 parameter measured. These differences persisted regardless of the arterial level treated (infrainguinal vs aortoiliac). However, despite this, patients with critical limb ischemia were able to maintain both their ambulatory ability and independent living status; more than 75% of patients were both ambulatory and independent at 1 year. Further examination showed that quality-of-life gains as measured by the SF-36 survey for claudicants at 6 months deteriorated in several categories at 1 year. This can perhaps be explained by a corresponding loss of primary patency in the same time interval.
It can be concluded that although claudicants feel better and feel better about their overall health than patients with critical limb ischemia, PTA achieves very good functional outcomes for both groups of patients at 1 year. Despite a disappointing and dismal primary patency rate of 35% in patients with critical limb ischemia, PTA seems to be very beneficial for measuring functional parameters such as maintenance of ambulation and independence. Although it would be interesting to measure these parameters against untreated controls (a conceded limitation of this study), it is still reasonable to conclude that, on the basis of preserving functionality at least in the short term, PTA is worthwhile in patients, regardless of presentation, who are amenable to this therapy.
It is important to remember that patients treated in this series were assigned treatment by the LEGS score protocol. This protocol tends to designate claudicants and functionally/medically high-risk patients to PTA.4 We believe that this explains the survey results of the SF-36 self-assessment for the critical limb ischemia group. The LEGS treatment algorithm generally selects sicker patients for PTA, using the rationale that good-risk patients live longer and thus need the benefit of more durable open procedures. It also uses the corollary that poorer-risk patients do not tolerate open surgery as well, do not need the durability of open operations, and thus are better treated with PTA. It is reasonable, therefore, to postulate that had we taken better-risk limb salvage candidates, the SF-36 data may have been different.
Irrespective of this, however, the data for patients with claudication are interesting and seem to support an argument for a more aggressive approach for patients with non–limb-threatening PAD. These findings are similar to those of Feinglass et al,1 who performed a functional outcomes assessment of more than 500 patients with claudication, 104 of whom underwent arterial intervention. They demonstrated considerable improvement in functional outcome for these patients as compared with a series of matched and unmatched controls who underwent medical management and concluded that intervention shows a measurable benefit for patients with claudication. Although the mainstay of therapy for claudication continues to be smoking cessation and monitored exercise (walking), this treatment modality has documented shortcomings. If one were to critically assess the literature regarding the noninterventional treatment of claudication, one could conclude that success, defined as the ability to walk and perform the tasks of daily living without leg pain, is possible in only one third of patients treated. Substance abuse data regarding cigarette smoking cessation published in the 1980s suggest that only one third of patients with smoking-related diseases will ever completely quit smoking cigarettes.9 Likewise, literature from Europe has suggested that only one third of patients are both physically able and mentally willing to participate in a meaningful exercise program to correct their claudication.10 Considering this, noninterventional therapy leaves up to two thirds of its sufferers without hope for a successful outcome.
Classic teaching would argue that the relatively benign natural history of claudication does not justify intervention. Studies also show that the benefits after revascularization when exercise performance is measured are more subjective than objective. In a study by Gardner and Killewich,11 it was not possible to demonstrate improved objective performance in the form of improved walking distance after revascularization, despite patients’ subjective belief that they were walking farther than before their intervention. They concluded from their findings that the benefits of revascularization are often subjective and that exercise training after intervention is necessary to accommodate the chronic muscle deconditioning that occurs with chronic PAD. Other studies have shown that the subjective benefits of PTA are often lost by 1 year when compared with cohorts subjected to supervised exercise and smoking cessation only.12, 13 Clearly this highlights the most glaring pitfall of our study: a follow-up of only 1 year. It would be interesting to retest the self health assessment in our study population at 2 years. Another possible shortcoming to our study is the method chosen to measure health-related quality of life. The SF-36 is considered a generic health-related quality-of-life measure. Reports from Europe have suggested that disease-specific quality-of-life questionnaires designed for patients with PAD may provide more reliable quality-of-life data.14, 15 However, a recent report by Izquierdo-Porrera et al16 suggests that the SF-36 questionnaire is as effective as disease-specific questionnaires. Our study used only the generic SF-36. Despite these shortcomings, patients treated in this prospective trial generally believed that they benefited from interventional therapy. These data incrementally add to the growing body of evidence rationalizing a more aggressive approach for claudication.
Finally, this trial exposes the problematic patient population with critical limb ischemia. Although PTA seemed to preserve the ability to walk and maintain independence, it did not seem to improve overall quality-of-life. In other data published from our institution, the postoperative functional outcome was often predetermined by the functional status of the patient at presentation.17 Elderly patients with preoperative ambulatory impairment, dementia, and end-stage renal disease often achieved very little improvement in their functional performance after objectively successful revascularization, regardless of whether the treatment was PTA or open bypass. On the basis of this experience, it has been our opinion that we overtreat some patients with critical limb ischemia. If one were to take a skeptical perspective, the data in this report show that PTA resulted in amputation-free survival in only half the cases and provided no improvement in patient health self-assessment. These outcomes are far from an endorsement of PTA for the treatment of patients with critical limb ischemia. All things considered, the aggregate findings of this report have done little to change our original opinion. Clearly, more prospective research in this area is needed to determine which patients will derive a functional benefit from intervention and which will not.
In summary, technological advancements in the percutaneous treatment of PAD have enabled proceduralists to successfully treat more complex arterial lesions. Despite documented limitations in the technical parameter of arterial patency, excellent functional outcomes with good quality-of-life assessment are attainable with PTA. This is particularly true in patients with claudication. On the grounds of improving functionality, our findings support a growing body of literature advocating a more aggressive percutaneous interventional approach to patients with vasculogenic claudication.
Author contributions
References
- . Functional status and walking ability after lower extremity bypass grafting or angioplasty after intermittent claudication (results from a prospective outcomes study) . J Vasc Surg . 2000;31:93–103
- . Patient recovery after infrainguinal bypass grafting for limb salvage . J Vasc Surg . 1998;27:256–266
- . Management of peripheral arterial disease . J Vasc Surg . 2000;31(Suppl):117–121
- The LEGS score (a proposed scoring system to direct treatment of chronic lower extremity ischemia) . Ann Surg . 2003;237:812–819
- The invasive treatment of chronic limb ischemia according to the Lower Extremity Grading System (LEGS) score (a six-month report) . J Vasc Surg . 2004;39:1268–1276
- Does a standardization tool to direct invasive therapy of symptomatic lower extremity peripheral arterial disease improve outcomes? . J Vasc Surg . 2004;40:907–915
- . September 20 The SF-36 Health Survey (version 2.0) technical note . Boston: Health Assessment Lab; 1996; (update September 27, 1997)
- . Management of peripheral arterial disease . J Vasc Surg . 2000;31(Suppl):S110
- . The effect of advice to stop smoking on arterial disease patients assessed by serum thiocyanate levels . J Cardiovasc Surg (Torino) . 1980;5:568–569
- An epidemiologic study of the value and limits of physical therapy/exercise therapy in Fontaine stage II arterial occlusive disease . Vasa Suppl . 1992;38:1–40
- . Lack of functional benefits following infrainguinal bypass in peripheral arterial occlusive disease patients . Vasc Med . 2001;6:9–14
- . Exercise training versus angioplasty for stable claudication. Long and medium term results of a prospective, randomised trial . Eur J Vasc Endovasc Surg . 1996;11:409–413
- Randomised controlled trial of percutaneous transluminal angioplasty for intermittent claudication . Eur J Vasc Endovasc Surg . 1996;12:167–172
- . Developing the Vascular Quality of Life Questionnaire (a new disease-specific quality of life measure for the use in lower limb ischemia) . J Vasc Surg . 2001;33:679–687
- Comparison of generic and disease-specific questionnaires for the assessment of quality of life in patients with peripheral arterial disease . J Vasc Surg . 2005;41:261–268
- Relationship between objective measures of peripheral arterial disease severity to self reported quality of life in older adults with intermittent claudication . J Vasc Surg . 2005;41:625–630
- Postoperative outcomes according to preoperative medical and functional status after infrainguinal revascularization for critical limb ischemia in patients 80 years and older . Am Surg . 2005;71:640–646
Competition of interest: none.
PII: S0741-5214(06)00783-X
doi:10.1016/j.jvs.2006.04.045
© 2006 The Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.
