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NDT Advance Access originally published online on January 31, 2007
Nephrology Dialysis Transplantation 2007 22(4):1144-1149; doi:10.1093/ndt/gfl764
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© The Author [2007]. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

Percutaneous transluminal angioplasty is feasible and effective in patients on chronic dialysis with severe peripheral artery disease

Lanfroi Graziani1, Antonio Silvestro1, Vittorio Bertone2, Ermanna Manara3, Alberto Alicandri4, Giovanni Parrinello5 and Annunciata Manganoni6

1Servizio di Emodinamica, Istituto Clinico "Città di Brescia", Brescia, 2Unità di Diabetologia, Casa di Cura Clinica Castelli, Bergamo, 3Unità Operativa di Medicina e Oncologia, Istituti Ospedalieri di Cremona, Cremona, 4Unità di Medicina Interna, Spedali Civili di Brescia, Brescia, 5Sezione di Statistica Medica e Biometria, Università di Brescia, Brescia and 6Servizio UFA Nefrologia e Dialisi, Ospedale Val Camonica-Sebino, Esine, Italy

Correspondence and offprint requests to: Dr Lanfroi Graziani, Servizio di Emodinamica, Istituto Clinico Città di Brescia, Via Gualla 15, 25123 Brescia, Italy. Email: langrazi{at}tin.it



   Abstract
Top
 Abstract
Introduction
 Subjects and methods
 Results
 Discussion
 Conclusions
 References
 
Background. Peripheral arterial disease (PAD) is common among patients on chronic dialysis. Despite severe clinical manifestations, the indication for bypass surgery is controversial, because of the high morbidity and mortality rate of these patients. The less invasive percutaneous transluminal angioplasty (PTA) is a possible alternative, but data about PTA in dialysis patients are scarce.

Methods. We followed 107 dialysis patients (mean age 67 ± 10, 75 males) with 132 ischaemic limbs (97% with critical limb ischaemia and ischaemic foot lesions or rest pain) consecutively treated by PTA.

Results. PTA was successful in 97% of cases. Median follow-up was 22 months. Cumulative limb salvage rates at 12, 24, 36 and 48 months were 86, 84, 84 and 62%, respectively. Log-rank test showed an association between major amputation and baseline presence of foot lesions (P = 0.04). This association was confirmed by a Cox survival multivariate analysis [hazard ratio (HR) = 7.03, 95% confidence interval (CI) = 1.1–43.0, P = 0.035]. Limb salvage without any new intervention on the same leg was achieved in 70% of the cases, and was associated with the absence of diabetes mellitus (P = 0.01), lower number of treated lesions (P = 0.04) and proximal level (iliac and/or femoro–popliteal) of PTA (P < 0.001). Independent predictors were diabetes mellitus (HR = 3.47, 95% CI = 1.31–9.17, P = 0.01) and proximal PTA (HR = 0.28, 95% CI = 0.08–0.94, P = 0.04). Fifty-three (49%) patients died during follow-up. Patients older than 67 years (the median value in our sample) had a 2.4-fold increase in mortality risk (95% CI = 1.4–4.1, P < 0.001).

Conclusions. PTA is feasible and effective in dialysis patients with PAD, and should be preferred to other more invasive interventions.

Keywords: critical limb ischaemia; dialysis; end-stage renal disease; percutaneous transluminal angioplasty; peripheral artery disease



   Introduction
Top
 Abstract
 Introduction
Subjects and methods
 Results
 Discussion
 Conclusions
 References
 
End-stage renal disease (ESRD) and chronic dialysis are associated with a higher prevalence of lower limb peripheral artery disease (PAD) [1]. Since life expectancy, which is limited among ESRD subjects [2], is further decreased in PAD patients on chronic dialysis [3], the treatment of peripheral vascular complications in such patients is controversial [4]. Furthermore, in dialysis subjects, PAD is accompanied by diffuse vascular calcifications [5] and involvement of distal infrapopliteal and foot arteries [6].

With respect to clinical manifestations, as compared with PAD non-dialysis patients, PAD patients on chronic dialysis have an increased risk of critical limb ischaemia (CLI) and limb loss [7]. It has been shown that complications from CLI are among the main causes of death in dialysis patients [8] and survival is reduced after major amputation [9]. Therefore, theoretically the possibility of restoring appropriate blood flow to the foot should always be evaluated.

Bypass surgery in ESRD patients may be difficult to perform because of the hard calcifications of distal vessels. A poor limb salvage rate after surgical revascularization has been reported, with associated high perioperative mortality [10–12].

Percutaneous transluminal angioplasty (PTA) represents a valid alternative to bypass surgery in most patients with PAD of lower limbs, showing a better safety profile and good clinical efficacy [13,14]. As compared with the indications initially furnished by an expert committee [15], the application of PTA has been extended in the past years [16], also to important technical improvements in adopted devices. Nevertheless, although the downsizing of materials can facilitate the treatment of infrapopliteal arteries, typically affected in ESRD patients, experience and ability of the single surgeon are required to approach calcified lesions of distal and thin vessels.

Up to date, few data are available on endovascular treatment of lower limb PAD in ESRD patients [17]. The aim of the present study is to assess the feasibility and efficacy of endovascular catheter-based techniques for severe PAD in patients on chronic dialysis.



   Subjects and methods
Top
 Abstract
 Introduction
 Subjects and methods
Results
 Discussion
 Conclusions
 References
 
Patients
The study population includes 107 (132 ischaemic limbs) consecutive ESRD patients on chronic dialysis treated at our institution for symptomatic PAD between 2000–2004. All patients were on chronic dialysis, for at least 6 months. Ethic Committee approval was not required for this retrospective review.

All patients were on haemodialysis, except one who was on peritoneal dialysis. They were referred to our institution for angiography and, whenever possible, endovascular treatment by several Dialysis and Diabetic Foot Centres in middle and northern Italy. Patients were screened at their originating centre for the presence of PAD because of suspicious symptoms such as leg pain or other complaints while walking, rest pain or presence of skin lesions (ulcer and/or gangrene). PAD screening was carried out by Duplex scanning and measurement of transcutaneous oximetry. Ankle–brachial index measurement is of little utility in this category of patients with continuous vessel calcification and less compressible vessel [5]. Once an objective demonstration of PAD presence was obtained, patients were referred to us. Out of the 112 dialysis patients sent to us in the study period, 5 were excluded because angiography did not find any relevant lesions to be treated in those subjects and, thus, there was no indication to perform endovascular treatment.

Endovascular procedure
The procedures were performed by a single experienced operator (LG) under local anaesthesia through an antegrade puncture of the ipsilateral common femoral artery. In the case of obstructions along the iliac axis and/or at the common femoral artery level, the procedure was performed by means of controlateral femoral artery catheterization. A 5–7 French sheath was positioned to perform a preliminary angiography. In the case of significant obstructions (≥50% diameter reduction), sodium heparin (5000 IU) was given intra-arterially and PTA attempted. In no case, after angiography, was it decided that the anatomic characteristics of obstructions were unsuitable for endovascular revascularization attempt. The aim of the procedure was to treat each iliac, femoro–popliteal and below-the-knee significant obstructions, in order to obtain direct flow to the foot. Alternatively, in the case that it was not possible to attain tibial artery revascularization and/or good collateral branches from distal peroneal to foot arteries, the PTA scope could be used to gain direct flow through the peroneal artery. In the case of iliac stenosis or occlusion, crossing was made by 0.035'' idrophilic wire, predilatation, if necessary, by mean of 5–6 mm diameter balloon catheters, and final treatment by using balloon-expandable Palmaz-type stent or deployment of self-expandable nitinol stent. Superficial femoral and popliteal artery lesions were usually crossed by using 0.035'' wires, whereas dilatations were performed by 4–6 mm diameter balloon catheters. To achieve good angiographic results, prolonged dilatation time (180 s) was used. In infrapopliteal arteries, crossing of lesions was performed by using 0.014'' coronary-type idrophilic stiff guide-wires. For dilatation, balloon sizes were in the range 1.5–3.5 mm. In the case of a non-satisfactory result (residual stenosis >30% and/or flow-limiting dissection), a new prolonged dilatation was performed. If angiograghy still did not show a good result, stent release was considered. All patients were treated with antiplatelet drugs after the procedure (ticlopidine 250 mg b.i.d., clopidogrel 75 mg/day for 60 days following the procedure, then either ticlopidine 250 mg/day or aspirin 100–300 mg/day).

Morphological classification
All patients with isolated below-the-groin disease were categorized according to a new morphological classification of disease severity based on seven classes of increasing arterial involvement (Table 1). This classification, routinely used in our catheterization laboratory, was adopted to define significant improvement of morphological disease condition after endovascular treatment.


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  		Table 1. Morphological classification of below-the-groin arterial lesion distribution based on seven classes of progressive severity

 
Follow-up
After discharge, patients were referred to their originating dialysis and/or diabetic foot centres and followed by physicians working in those centres. Data were obtained from us by periodic telephonic consultations with colleagues treating those patients. Study endpoints were: target extremity revascularization (TER), major amputation and death. Minor amputations were assessed but not quoted as study endpoints.

Definitions
CLI was defined according to the TransAtlantic Inter-Society Consensus (TASC) criteria [15]. In all treated limbs, technical success was defined by absence of residual obstructions after treatment. A treated artery was considered free from residual obstructions in the case of residual stenosis <30% and in the absence of flow-limiting dissections on the final angiogram. In the case of isolated below-the-groin disease, the aforementioned morphological classification of disease severity was applied and a significant improvement was defined by a downward shift of at least one category. The endovascular intervention was considered as an inflow procedure if performed at iliac and/or femoro–popliteal levels, and a below-the-knee (BTK) intervention if performed at the infrapopliteal level. Primary clinical efficacy was defined as limb salvage without any TER. Major amputation was defined as limb loss above the metatarsal level, whereas minor amputation referred to transmetatarsal amputation or removal of more distal parts of the lower extremity.

Statistical analysis
Demographic and clinical characteristics of the study population are reported as mean ± SD for continuous variables or as median and interquartile range (IQR) according to their distribution and as number (percentage) for categorical variables. All limbs with attempted revascularization were included (intention-to-treat analysis). Cumulative event rates were estimated with Kaplan–Meier survival curves, and possible statistical differences were evaluated by the log-rank test. The considered variables were as follows: age, gender, diabetes mellitus, hypertension, hyperlipidaemia, smoking habit, coronary artery disease, time from dialysis start, foot lesions, morphological classification of disease severity before and after PTA, PTA-induced change in morphological classification, direct tibial flow after PTA, number of treated lesions, kind (stenosis or occlusion) of lesion, and the level of the intervention, which was considered inflow PTA if performed at iliac and/or femoro–popliteal level, BTK PTA if performed at the infrapopliteal level and a combination of inflow + BTK PTA if both the levels were treated. Independent associations between variables and outcome were tested by multivariate Cox regression models. An approximate jack-knife estimate of the variance was estimated to take into account the correlation related to data of the same subject. A P value <0.05 was considered statistically significant.



   Results
Top
 Abstract
 Introduction
 Subjects and methods
 Results
Discussion
 Conclusions
 References
 
Baseline characteristics of patients and treated vessels and lesions are reported in Table 2. Diabetes mellitus was present in 54% of the patients. Four patients had had a previous controlateral major amputation. In most cases (97%), indication for the endovascular treatment was CLI with skin defects and/or rest pain. The most common treated segment was a combination of femoro–popliteal and BTK arteries. A total of 259 lesions were treated. In 48% of the treated limbs there was at least one occlusion, and at least an occlusion longer than 10 cm was found in 30% of the limbs. Two patients presented with a previous (>6 months) femoro–popliteal bypass graft, which was still patent in one case. Stents were used in 12 (9%) limbs. Elective stent deployment was limited to the iliac axis (n = 9), whereas it was the second choice in the case of a non-satisfactory result in the femoro–popliteal segment (n = 3). No stent was used in BTK vessels. No major periprocedural complication or in-hospital mortality was observed. In four cases distal embolization occurred: two were solved by catheter aspiration, and two by local fibrinolysis, with no clinical consequences overall. In six cases a small haematoma was observed at the entry site. The endovascular procedure was accompanied by a minor amputation in 16% of cases. Figure 1 shows an example of recanalization of an occlusion of distal anterior tibial artery and dorsal pedal arch by PTA.


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  		Table 2. Characteristics of 107 dialysis patients with 132 ischaemic limbs undergoing endovascular treatment

 

Figure 1
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  		Fig. 1. Example of recanalization by PTA of an occlusion involving distal anterior tibial artery and dorsal arch.

 
Primary technical success was achieved in 128 (97%) limbs. In 82 (62%) limbs, a direct flow to the foot was obtained through the anterior and/or posterior tibial artery. In 111 (84%) limbs, at least one of the infrapopliteal arteries, including peroneal artery, was patent and with direct flow after the procedure. Our morphological classification (Table 1) was applied to 123 limbs with isolated below-the-groin disease. A downshift of at least one class according to the proposed morphological classification was obtained in 116 out of 123 limbs (94%).

Median follow-up after intervention was 22 months, IQR = 16–30. A new intervention on the same leg was performed in 23 (17%) legs. A single new TER was necessary in 13 (10%) limbs, 2 TER during follow-up in 7 (5%), and up to 4 in 3 (2%) limbs.

Major amputation during follow-up was necessary in 20 (15.1%) limbs. Table 3 reports characteristics of patients and limbs divided according to the occurrence of major amputation during the follow-up period. The cumulative limb salvage rates (and 95% CI) at 12, 24, 36 and 48 months were 86 (80–93%), 84 (77–91%), 84 (77–91%) and 62% (39–99%), respectively. As shown in Figure 2, upper panel, major amputation tended to occur more commonly in the case of diabetes mellitus (P = 0.06 by log-rank test). Presence at baseline of ulcer and/or gangrene of the foot was significantly associated (P = 0.04, by log-rank test) with major amputation (Figure 2, lower panel). In a multivariate analysis, presence at baseline of ulcer and/or gangrene of the foot was an independent predictor of major amputation (HR = 7.03, 95% CI = 1.1–43.0, P = 0.035). In the subgroup of limbs with baseline presence of foot ulcer and/or gangrene, the cumulative limb salvage rates (and 95% CI) at 12, 24, 36 and 48 months were 82 (75–91%), 80 (72–89%), 80 (72–89%) and 49% (21–100%), respectively.


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  		Table 3. Demographic and clinical characteristics of patients, and PTA data of limbs divided according to the occurrence or not of major amputation during follow-up

 

Figure 2
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  		Fig. 2. Kaplan–Meier survival curve of amputation-free time for limbs, divided according to the presence or not of diabetes mellitus (upper panel) and foot lesions (lower panel).

 
Primary clinical efficacy, defined as limb salvage without any TER procedures, was obtained during the follow-up period for 92 limbs (70%). Factors associated with primary efficacy at the univariate analysis were diabetes mellitus (P = 0.01, by log-rank test), number of treated lesions (P = 0.04), number of occlusions (P = 0.02) and level of the intervention (P < 0.001). In a Cox proportional hazard regression model, factors independently associated with primary clinical efficacy were diabetes mellitus (HR = 3.47, 95% CI = 1.31–9.17, P = 0.01), and a proximal level (inflow PTA) of the intervention (HR = 0.28, 95% CI = 0.08–0.94, P = 0.04).

Fifty-three (49%) patients died during follow-up. Eight (8%) patients died during the first month of follow-up. No death was related to the PTA procedure. Cumulative patients survival (and 95% CI) at 12, 24, 36 and 48 months was 66 (59–75%), 57 (49–67%), 42 (32–55%) and 23% (12–43%), respectively. Patients older than 67 years (the median value in our sample) had an HR of 2.4 (95% CI = 1.4–4.1, P < 0.001).



   Discussion
Top
 Abstract
 Introduction
 Subjects and methods
 Results
 Discussion
Conclusions
 References
 
This is the first study to report data about mid-term outcome of endovascular treatment of severe PAD in a large series of consecutive dialysis patients, affected, in the majority of cases, by CLI with foot ulcer and/or gangrene. Our results indicate that PTA is safe and effective in this subset of extremely complicated subjects. Overall, the limb salvage rates at 2 and 4 year follow-up were 84 and 62%, respectively, whereas they were 80 and 49% if only patients with foot lesions were considered.

Technical considerations
Technical success was achieved in 96% of cases, and among limbs with isolated infrainguinal disease, a downward shift of at least one category according to the applied morphological score was observed in 94% of cases. These results are similar to previous reports [17], and thus are absolutely satisfactory considering that in the present series of dialysis patients, no case was a priori considered unsuitable for PTA attempt on the basis of angiographic findings. Endovascular treatment in the case of chronic dialysis may be technically challenging because of different factors: (i) the prevalent localization of lesions in distal vessels, with poor run-off, (ii) the calcified nature of very tight stenoses which make the crossing by balloon catheter problematic. To approach this kind of situation in the best possible way, it is essential to have high support by choosing an antegrade ipsilateral strategy; furthermore, it is advisable to use coronary-type thin (0.014'') and stiff guide-wires. Over such wires, it is possible to use a balloon catheter with the lowest possible profile. Even in the case of long occlusions, we discourage the primary use of subintimal angioplasty because the re-entry could be very difficult due to the extremely calcified nature of the lesions.

Limb salvage
We obtained a satisfactory limb salvage rate: overall during follow-up only 15% of limbs underwent major amputation. In the paper by Brosi et al. [17], a technical success rate of 97% is reported with a limb salvage rate of 73% at 1 year follow-up. Compared to that study, the present one is different due to the larger number of patients, larger proportion of subjects presenting with CLI and longer follow-up. The salvage rate in the present study seems to be better than that in the survey by Brosi et al. which, however, included only patients undergoing BTK angioplasty, with or without an additional inflow procedure.

Several papers describe the outcome of dialysis patients with PAD treated by bypass surgery [10–12,18]. The 2 year cumulative limb salvage rate reported has been in the range 50–85%. The 2 year cumulative salvage rate in our study is at the upper limit of this range. This is a relevant result considering that we performed intention-to-treat analysis and that in our series PTA has been performed on consecutive patients with no previous selection on the basis of angiographic or clinical criteria, which, on the contrary, are extensively used to select patients undergoing surgical revascularization. Furthermore, PTA is a less invasive procedure and should anyway be preferred because it is less expensive, with low complication and mortality rate, and, very importantly, its failure does not preclude future new endovascular intervention or bypass surgery [19]. In particular, in the case of foot ulcer, the restenosis occurrence, which is the main shortcoming of PTA, could be of little importance if the vessel remains open for the time necessary to promote ulcer healing. Indeed, it is thought that in CLI, and in the particular case of BTK angioplasty, angiographic restenosis is much higher than clinical reoccurrence [19].

Morphological scores
Disease severity in terms of obstructive burden in this series of patients was expressed by a new classification, which considers the number and the below-the-groin location of stenoses and occlusions. The need of such a score is due to the fact that haemodynamic impairment may be hardly expressed by other parameters in these patients, as ankle pressure may be strongly influenced by reduced arterial compressibility due to vascular calcification [5] and transcutaneous oximetry is influenced by other factors such as microcirculatory impairment [20]. Our score could be also applied to subjects with diabetes mellitus who share with dialysis patients' prevalent below-the-groin arterial involvement and diffuse vascular calcifications [6].

Mortality
Our data confirm the high mortality rate of dialysis patients with PAD [3,8]. Nevertheless, PTA, by avoiding limb loss and favouring symptom recovery, may result in important enhancement of quality of life. Considering that consequences of CLI are a direct cause of death in these patients [8], and that after major amputation survival is further reduced [9], one might conclude that revascularization improves survival in these patients. The reported 5 year survival rate in ESRD patients starting dialysis with CLI has been as low as 10% [8], whereas the 4 year cumulative survival in our population was 23%. Future studies are needed to verify whether an optimal revascularization may significantly decrease the mortality rate in dialysis patients with CLI.

Study limitations
Some limitations of the present study warrant discussion. First, wound care, which is important to promote limb salvage, has been provided by different physicians from different dialysis and/or diabetic foot centres. Thus, we cannot exclude that the quality of care may have been dissimilar for different patients. Second, we did not measure haemodynamic changes after PTA in terms of ankle and toe pressures. However, as stated earlier, those measurements are strongly influenced by vascular calcifications, which are extremely common in dialysis subjects [5]. Third, follow-up information was obtained by telephone consultation and not by physically visiting of the patients. However, considering that chosen endpoints were very easy to be assessed (death, major amputation and TER) and colleagues consulted were those treating patients every day and thus very familiar with them, follow-up data obtained can be considered appropriate.



   Conclusions
Top
 Abstract
 Introduction
 Subjects and methods
 Results
 Discussion
 Conclusions
References
 
Our data indicate that PTA is feasible and effective in most patients on chronic dialysis and CLI, with a limb salvage rate similar to the highest reported in literature for a surgical series [19]. Given the high comorbidity and reduced life expectancy of these patients [2,8], PTA should be the procedure of choice in the case of symptomatic PAD, because it is less invasive and expensive than open surgery. Future studies are needed to investigate the impact of optimal revascularization on survival in dialysis patients with CLI.

Conflict of interest statement. None declared.



   References
Top
 Abstract
 Introduction
 Subjects and methods
 Results
 Discussion
 Conclusions
 References
 

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  7. Faglia E, Clerici G, Clerisi J, et al. (2006) Early and five-year amputation and survival rate of diabetic patients with critical limb ischemia: data of a cohort of 564 patients. Eur J Vasc Endovasc Surg 32:484–490.[CrossRef][ISI][Medline]
  8. Koch M, Trapp R, Kulas W, Grabensee B. (2004) Critical limb ischaemia as a main cause of death in patients with end-stage renal disease: a single-centre study. Nephrol Dial Transplant 19:2547–2552.[Abstract/Free Full Text]
  9. Eggers PW, Gohdes D, Pugh J. (1999) Nontraumatic lower extremity amputations in the Medicare end-stage renal disease population. Kidney Int 56:1524–1533.[CrossRef][ISI][Medline]
  10. Sanchez LA, Goldsmith J, Rivers SP, et al. (1992) Limb salvage surgery in end stage renal disease: is it worthwile? J Cardiovasc Surg 33:344–348.[Medline]
  11. Johnson BL, Glickman MH, Bandvk DF, Esses GE. (1995) Failure of foot salvage in patients with end-stage renal disease after surgical revascularization. J Vasc Surg 22:280–285.[CrossRef][ISI][Medline]
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  15. Dormandy JA and Rutherford RB. (2000) Management of peripheral arterial disease (PAD). TASC Working Group. TransAtlantic Inter-Society Consensus (TASC). J Vasc Surg 31:Suppl, 1–296.[CrossRef][ISI][Medline]
  16. Leville CD, Kashyap VS, Clair DG, et al. (2006) Endovascular management of iliac artery occlusions: extending treatment to TransAtlantic Inter-Society Consensus class C and D patients. J Vasc Surg 43:32–39.[CrossRef][ISI][Medline]
  17. Brosi P, Baumgartner I, Silvestro A, et al. (2005) Below-the-knee angioplasty in patients with end-stage renal disease. J Endovasc Ther 12:704–713.[CrossRef][ISI][Medline]
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Received for publication: 2. 8.06
Accepted in revised form: 22.11.06


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