Safety and efficacy of endovascular treatment of chronic ischemia of the lower limbs in 6-months follow-up

Introduction

Treatment of the peripheral arterial occlusive disease (PAOD) depends on the severity of ischemia. In patient with intermittent claudication (IC) the primary goal is to improve the comfort of living – it has not been proved, that revascularisation increases the limb salvage rate. In critical limb ischemia (CLI) the aim is to save the limb – to avoid both the permanent disability of the patient and the costs related to amputation – social costs and the costs covered by the health insurance system. The aim of revascularisation is also to preserve life – it has been shown that the CLI patients die earlier if the revascularisation was unsuccessful or not attempted [1−3].

The optimal choice between different modes of PAOD treatment: conservative treatment, vascular surgery, endovascular therapy or primary amputation should take into account safety, effectiveness and costs of each of these modalities. It is worthwhile to analyse data from our own country as reports from abroad based on observations made within a differently organised and reimbursed health system may substantially differ from what one can obtain in Poland. Also, it is worthwhile to find what can be achieved when a treatment strategy implementing the results of up to date medical trials, and taking into account the current reimbursement system effective in Poland is used. Each medical trial assesses the efficacy and safety of a specific treatment technique used when some medical and anatomical conditions are met. Accordingly, the results are representative for a subset of PAOD patients who fulfill conditions specified in the study protocol. It is interesting to assess the efficacy and safety of a combined use of all techniques in the treatment of a large population of patients, with a full complexity of arterial lesions which one can find in daily practice.

The aim of the study

The aim of the paper is to provide data on the safety and efficacy of endovascular treatment of PAOD. The observation was carried out in a centre of interventional angiology performing some 1,300 of endovascular procedures a year, out of which some 70% are performed in order to treat the PAOD.

Material and methods

The analysis is based on data recorded prospectively in the Malopolska Endovascular Registry [4] and relates to all procedures and patients treated within a full year, between 1st of August 2010 and 31st of July 2011. Authors tried to estimate:

– the safety of a single endovascular procedure;

– the proportion of patients in whom the treatment is successful at 6 months of follow-up (the treatment was meant as either a single or a series of endovascular procedures performed sequentially until an optimal result is obtained);

– the amputation free survival and freedom from MACE at 6 months.

The treatment and follow-up was carried out in the Department of Angiology of the Jagiellonian University in Cracow, which is the largest provider of peripheral arterial endovascular treatment in the south-eastern part of Poland, performing annually some 1,300 peripheral endovascular procedures, out of which some 70% were procedures performed in order to treat the PAOD.

Techniques of endovascular treatment

The main goal was to increase the blood flow to the ischemic region by restoration of the patency of axial arteries of the limbs. When this was impossible due to technical reasons, an attempt was made to increase the blood inflow into the collateral circulation. Sometimes, when complex lesions were treated, a staged procedure was performed, for example, an iliac artery was recanalised intitially and the arteries of the femoro-popliteal or below the knee (BTK) segments were treated in the next step. Therefore the total number of performed endovascular procedures exceeds the total number of treated legs. The end part of a staged procedure was regarded the end of treatment. If two legs were treated in one patient each leg was observed and analysed separately in appropriate time intervals. Even though a single arterial puncture was performed in the most of these cases, the treatment was regarded as two separate procedures.

Vascular access

A femoral artery retrograde access – either ipsi – or contralateral – was used for most of the revascularisation procedures within the aorto-iliac segment. An upper limb arterial access was used infrequently.

In femoro-popliteal or below the knee (BTK) revascularisations we preferentially used an ispilateral, antegrade puncture of a proximal part of the superficial femoral artery. Less frequently, the common femoral artery puncture was performed. An access via left axillary atery or contralateral common femoral artery was rarely used, mainly in cases when obstructive lesions were located near the ipsilateral superficial femoral artery origin.

When we could not pass the guidewires into the arterial lumen beyond an occlusion, ancillary methods were used: either a distal arterial, retrograde puncture was performed (using anterior tibial, posterior tibial, peroneal or superficial femoral artery for arterial access) or a recanalisation device was used – the Outback (Cordis, a Johnson & Johnson Co, Miami Lakes, FL, USA) or the Pioneer (Medtronic, Inc., Minneapolis, Minnesota, USA).

In most of the cases, after the sheath removal a compression of the puncture site was performed. An arterial closure device, mainly the AngioSeal (St Jude Medical, Minnetonka, Minnesota, USA), was used in a minority, mainly in restless, non-cooperative patients or in patients with end stage renal disease.

Treatment options

Treatment was planned in accordance with the TASC 2 guidelines, based on clinical presentation, findings on angiography or computed tomography of the lower legs and taking into account the risks related to invasive treatment – open surgery or endovascular procedure.

Stent angioplasty was the most frequently used endovascular treatment modality, plain percutaneous transluminal angioplasty (PTA) being the second most common. In severe calcifications of the femoro-popliteal segment, directional atherectomy or scoring balloon angioplasty were used. Drug eluting balloon (DEB) angioplasty, other forms of PTA or drug eluting stents (with the exception of BTK stent angioplasty) were not used. Local fibrinolysis was used in acute arterial thrombosis. High radial force stents (Supera, IDEV) were utilised in a few cases.

In patients with borderline kidney insufficiency and in some cases of BTK angioplasty, intravascular ultrasonography was used in order to decrease the dose of the contrast media or to measure precisely the diameter of an occluded BTK artery, thus to determine the best diameter of the balloon of the PTA catheter and optimise the angioplasty results.

In the aorto-iliac segment direct stenting was preferentially used. Stent assisted angioplasty was used only when it was impossible to pass the stent through the stenotic segment without predilatation or when severe calcifications and low diameter of the arteries increased the probability of vessel rupture or could preclude full expansion of the stent. PTA without stenting was seldom performed. No other endovascular techniques were used in this anatomical location.

The way obstructive lesions in the femoro-popliteal segment were treated depended on the location, type and length of the lesion. The TASC 2 ‘A’ lesions were preferentialy treated by means of stent-assisted PTA. In TASC 2 ‘B’, ‘C’ and ‘D’ lesions located within the superficial femoral artery direct stenting was the preferred technique. Long lesions within the popliteal artery were preferentially treated by stent-assisted angioplasty, using balloon catheters with long balloons and balloons with diameter slightly inferior to the nominal diameter of the artery. In massive calcifications of the arteries either directional atherectomy or scoring balloon angioplasty were preferentially used. Subintimal angioplasty using the Bolia technique [5] was used on a few occasions.

Common femoral artery (CFA) or deep femoral artery (DFA) angioplasty were performed rarely, mostly as a form of bridge therapy – before a scheduled vascular surgery. It was performed in order to maintain the patency of a treated, adjacent arterial segment, for example, an angioplasty of a CFA tight stenosis was performed just after a successful recanalisation of the ipsilateral external iliac artery. The angioplasty of the CFA or DFA was also performed in cases of acute complications of the endovascular procedure – thrombosis or embolisation of these vessels – and when lesions were located at the superficial femoral artery (SFA) origin.

Balloon angioplasty utilising microcatheters with long balloons and, if necessary, scoring balloon angioplasty were preferentially used in the BTK arteries. Stents were implanted in approximately 12% of the BTK interventions. Drug eluting stents (DES) were implanted solely into the proximal part of the BTK arteries in cases of short occlusions, in flow limiting dissections of the vessels or to optimise the results of distal popliteal artery stenting. There were no other endovascular techniques used in the BTK region.

Control angiography (started out at the level of treated region and finished at the level of the foot) were done at the end of the each endovascular procedure. The visual assessment of the revascularisation were performed and categorized into one of four groups: increase in flow through axial artery(-ies), increase in flow through collateral artery(-ies), no visible change in flow, worsening of flow. Also complications (distal embolisations, thrombosis, discetions and vessels ruptures) were looked for in control angiography. The endovascular treatment of the complications was preferred. If possible, complications were treated immediately (during the same procedure which lead to the complication) and then were marked in the Registry as extension of the range of the endovascular procedure. All complications requiring invasive treatment which required surgical treatment or were not treated immediately were included into the re-intervention group and shown as serious adverse events (SAE).

Medical treatment

Patients treated by bare stent implantation were maintained on double antiplatelet medication (ASA and clopidogrel) for at least 4 weeks and then it was switched to one antiplatelet medication for lifelong. Those who were treated with drug eluting stent (DES) implantation received a double antiplatelet therapy for 12 months and then it was switched to one antiplatelet medication for lifelong. The rest were maintained on a single antiplatelet medication lifelong. All patients received statins in moderate to high dose-depending on drug tolerance. Risk factors for PAOD were sought for and eliminated. Treatment of concomitant diseases was carried out as needed.

Safety of endovascular procedures

Safety of the endovascular treatment was assessed by monitoring the perioperative serious adverse events (SAE). The SAE included death, TIA and stroke, acute coronary syndrome, leg amputation (other than necrectomy limited to the foot), need of the surgical or endovascular reintervention and severe heart failure occurring up to 1 month after the treatment. The SAE rate was calculated by dividing the number of the recorded complications by the number of all performed endovascular procedures, including all steps in multistage treatment as well as reinterventions after previous treatment.

Effects at 6 months follow-up

The results of the endovascular treatment was categorized into one of three groups: failure of primary procedure, no change and primary success.

The failure of primary procedure indicated exacerbation of the ischemia by at least 1 stage according to the Rutherford classification, amputation of the treated leg above the ankle level or reintervention (surgical or endovascular) within treated region. Primary success indicated reduction of the ischemia by at least 1 according to the Rutherford classification without reintervention. Other results were classified as the lack of improvement.

Frequency of the CLI (defined according to the TASC 2 consensus) [1] as well as the value of the ankle-brachial index (ABI) or if needed the toe-brachial index (TBI) and quality of life before treatment and after follow-up were measured. Also occurrence of major adverse clinical effects (MACE) – i.e. death, TIA and stroke, acute coronary syndrome, leg amputations (other than necrectomy limited to the foot), surgical or endovascular reintervention within the treated segment occurring up to 6 months after procedure) were monitored. The MACE rate was calculated by dividing the number of MACE events by the number of treated patients.

Clinical status was evaluated during scheduled visits 1, 3 and 6 months after the procedure or during the extra visit in the case of exacerbation of the ischemia.

The VascuQoL and EuroQuol (EQ5D-3L) questionnaires were used for assessment of the quality of life [6−8]. Only patients who filed up the questionnaires before treatment and after follow-up completely were analyzed.

We were at pains to achieve regular follow-up visits of all patients. If the patient could not appear in person the basic clinical information (estimation of the ischemia according to the Rutherford classification, appearance of the adverse events) were collected by phone, by the trained nurse.

Every endovascular procedure was categorized into the appropriate anatomical group according to the lowermost treated segment. For example, if the endovascular treatment involved arteries of the femoro-popliteal and BTK regions (regardless one or multi-stage treatment) procedure was classified into the BTK group.

Table I. Indications for treatment according to the Rutherford classification and classification of the lesions according to the TASC 2, in relation to the vascular segments of all treated legs (including multi step treatment)
Tabela I. Wskazania do leczenia wewnątrznaczyniowego według klasyfikacji Rutherford oraz morfologiczna klasyfikacja zmian według klasyfikacji TASC 2 w odniesieniu do poszczególnych segmentów anatomicznych

Poziom anatomiczny
(anatomical level)

Aortalno-biodrowy
(aorto-iliac)
n = 279

Udowo-podkolanowy
(femoro-popliteal)
n = 256

Poniżej kolana (BTK)
n = 298 

Ogółem (total)
n = 833

Stopień niedokrwienia
stage of ischemia

n (%)

n (%)

n (%)

n (%)

Rutherford 1

1 (0.4)

0 (0)

0 (0)

1 (0,1)

Rutherford 2

6 (2.1)

5 (2)

0 (0)

11 (1,3)

Rutherford 3

239 (85.6)

168 (65.6)

73 (24,5)

480 (57,6)

Rutherford 4

14 (5)

33 (12.9)

52 (17,4)

99 (11,9)

Rutherford 5

17 (6.1)

43 (16,8)

149 (50)

209 (25,1)

Rutherford 6

2 (0.7)

7 (2,7)

24 (8,1)

33 (4)

Klasyfikacja TASC
(TASC classification)

 

 

 

 

TASC A

120 (43)

43 (16.8)

 

 

TASC B

98 (35.1)

79 (30.8)

 

 

TASC C

29 (10.4)

59 (23)

 

 

TASC D

31 (11.1)

75 (29.3)

 

 

Total number of performed procedures (980) exceeds total number of treated legs (833) because in some cases treatment required more then one procedure. *in one case the T ASC 2 classification not applicable — an internal iliac artery PTA was performed in a patient with buttock claudication;

Statistical analysis

All categorical variables were expressed as frequencies/percentages (eg. clinical improvement, complications, failure of the therapy) or as mean values ± standard deviations (ABI, QoL). Between groups comparisons were assessed by Pearson c2 Test or Fisher’s Exact Test. Differences between means were evaluated using paired Student’s t-test or Wilcoxon test. All statistical tests were two-sided. Statistical significance was defined at a p-value less than 5%. The analysis was performed with JMP 9.0.0. software.

Results

Indication for treatment, anatomical segment, angiographic results, periprocedural complications

A total of 980 endovascular procedures were performed to treat 761 patients (833 limbs, CLI in 341 limbs – 41.6%). The details are listed in table 1.

Overall an angiographic improvement in terms of visible increase in blood flow was seen in majority of cases. Good angiographic result – flow increase through the axial vessels or through the collaterals was seen in 97.7% and 95.3% of the endovascular procedures performed to treat the non-CLI and CLI patients, respectively (tab. 2, fig. 1).

Table II. Effect of the endovascular procedure as of visual assessment of postprocedural angiography. CLI — critical limb ischemia
Tabela II. Wynik zabiegu w ocenie angiografii na zakończenie zabiegu wewnątrznaczyniowego; KNK — krytyczne niedokrwienie kończyn

Wynik w ocenie końcowej angiografii (angiographic result)

 

Poprawa napływu przez tętnice osiowe (increase in flow through axial arteries)

Poprawa napływu przez krążenie oboczne (increase in flow through collateral arteries)

Brak zmian napływu
(no change in flow)

Pogorszenie napływu
(deterioration of flow)

Pacjenci z KNK
(CLI patients)

362 (88.7%)

27 (6.6%)

14 (3.4%)

5 (1.2%)

Pacjenci z chromaniem
(non — CLI patients)

557 (97.4%)

2 (0.3%)

12 (2.1%)

1 (0.2%)

Figure 1. Effects of the endovascular procedure as of visual assessment of postprocedural angiography; CLI — critical limb ischemia, IC — intermittent claudication; increase via axial artery — increase in flow to the periphery vial axial artery (-ies), increase via collaterals — increase in flow via collateral arteries, no change — no change in flow to the periphery, detrerioration of flow — visible decrease of flow to the periphery
Rycina 1. Wynik zabiegu w ocenie angiografii na zakończenie zabiegu wewnątrznaczyniowego; KNK — krytyczne niedokrwienie kończyn; IC — chromanie przestankowe; wzrost tętnicami osiowymi — wzrost napływu na obwód naczyniami osiowymi; wzrost kolateralnie — wzrost napływu na obwód przez naczynia krążenia obocznego, brak zmian — brak zauważalnych zmian w napływie na obwód, pogorszenie przepływu — zauważalny spadek napływu krwi na obwód

The serious adverse events (SAE) are listed in detail in table 3 and figure 2.

Table III. Perioperative serious adverse events (SAE)
Tabela III. Poważne zdarzenia niepożądane (SAE) do 30 dni od zabiegu

Poważne zdarzenia niepożądane do 30 dni (SAE up to 30 days after treatment)

 

KNK (CLI)
n = 408

Chromanie (non-CLI) n = 572

 

Zgon (death)

6 (1.5%)

0

p < 0.001

Amputacja (amputation)

11 (2.7%)

0

p < 0.001

Reinterwencje wewnątrznaczyniowa
(endovascular reintervention)

5 (1.2%)

2 (0.3%)

NS

Doraźne leczenie chirurgiczne
(urgent vascular surgery)

1 (0.2%)

1 (0.2%)

NS

OZW (ACS)

2 (0.5%)

1 (0.2%)

NS

Udar/TIA (stroke/TIA)

1 (0.2%)

0

NS

Inne ciężkie (other severe)

2 (0.5%)

4 (0.7%)

NS

Razem (total)

28 (6.9%)

8 (1.3%)

p < 0.01

n — number of endovascular procedures, ACS — acute coronary syndrome, TIA — transient ischemic attack. The “other severe complications” category includes two cases of acute left heart failure, 1 MAS syndrome, 1 haemoragic shock caused by rupture of the iliac artery (treated effectively with covered stent), 1 massive DVT, 1 hepatic insufficiency resulting from a statin therapy.

Figure 2. SAE up to 30 days after en dovascular procedure — the rate of complicated procedures and type of complications; amput — amputation above the ankle, endovasc — repeated endovascular treatment, vasc — vascular surgery, ACS — acute coronary syndrome; CLI — critical limb ischemia, IC — intermittent claudication
Rycina 2. Poważne zdarzenia niepożądane do 30 dni po zabiegu (SAE) — odsetek powikłanych zabiegów i rodzaj powikłania; amput. — amputacja powyżej stawu skokowego; endowask. — ponowny zabieg wewnątrznaczyniowy, vasc — operacja naczyniowa, OZW — ostry zespół wieńcowy, KNK — krytyczne niedokrwienie kończyn, IC — chromanie przestankowe

The 30-day mortality rate for the whole group was 0.6%: there were 6 deaths in the CLI group (1.5%) while there were no deaths in IC group (p < 0.001).

There was a need of urgent surgical revascularization in two cases (0.4%): 1 due to a common femoral artery thrombosis resulting from postprocedural groin compression in a CLI patient and 1 due to a distal embolisation to the tibio-peroneal trunk, which occurred after a PTA of the contralateral common iliac artery in a non-CLI patient. There were 36 more complications which required an extension of the endovascular procedure (artery rupture, haemorrhage, peripheral embolisation, vessel dissection and other) – all of them were successfully treated using endovascular techniques. Overall major perioperative SAE were more common in the CLI patients (28 cases – 6.9%) compared to the non-CLI patients (8 cases – 1.3%; p < 0.001).

Table IV. Clinical results after 6 months follow-up legs treated for CLI
Tabela IV. Wyniki 6-miesięcznej obserwacji leczonych kończyn z powodu krytycznego niedokrwienia

Pacjenci leczeni z powodu krytycznego niedokrwienia kończyn (patients treated for critical limb ischemia CLI)

Poziom anatomiczny (anatomical level)

Aortalno-biodrowy
(aorto-iliac)

n (%)

Udowo-podkolanowy
(femoro-popliteal)

n (%)

Poniżej kolana (BTK)

n (%)

Ogółem (total)

n (%)

Pacjenci (patients)

32

83

217

332

Kończyny (legs)

33

83

225

341

Results after 6 months follow-up

Pierwotny sukces
#(primary success)

20 (60.6)

44 (53)

120 (53.3)

184 (54)

Brak poprawy
(no change)

3 (0.9)

17 (20.5)

50 (22.2)

70 (20.5)

Niepowodzenie
(primary failure)*

7 (21.2)

17 (20.5)

43 (19.1)

67 (19.7)

amputacja

6 (18.1)

5 (6)

15 (6.7)

26 (7.6)

reinterwencja

0 (0)

10 (12)

28 (12.4)

38 (11.1)

pogorszenie

1 (3)

2 (2.4)

5 (2.2)

8 (2.3)

Zgon (death)

2 (6)

5 (6)

17 (7.5)

24 (7)

Brak kontaktu
(lost to follow up)

1 (3)

0 (0)

0 (0)

1 (0.3)

Zaawansowanie niedokrwienia 6 miesięcy po zabiegu (severity of ischemia at 6 months)

Kończyny bez KNK
(legs without CLI)

19 (79.2)

50 (68.5)

116 (58.6)

185 (62.7)

Kończyny z KNK
(legs with CLI)

5 (20.8)

23 (31.5)

82 (41.4)

110 (37.3)

#primary success — reduction of the ischemia by at least 1 according to the Rutherford classification without reintervention or amputation, *primary failure was defined as exacerbation of the ischemia by at least 1 stage according to the Rutherford classification, need of revascularisation or amputation

Results at 6 months

The results are listed in the table 4 and 5.

Over the course of 6 months 30 patients died – 24 in the CLI (7%) and 6 in the IC group (1.2%; p < 0.001). One death occurred during follow-up in a patient who had undergone 2 procedures (bilateral PTA of the iliac arteries); 4 patients were lost to follow-up (0.5%). Thus, of the 761 patients and 833 treated limbs, 727 patients and 798 treated limbs were available for analysis. Some 87% of patients were evaluated during their follow-up visits, the rests of the patients were interviewed over the phone.

Primary success of treatment – an increase by at least 1 Rutherford category without the need for re-intervention, was noted in 596 limbs (71.5%) – 184 in the CLI (54%) and 412 in IC (83.7%; p < 0.001)

Table V. Clinical results after 6 months follow-up legs treated because of claudication
Tabela V. Wyniki 6-miesięcznej obserwacji kończyn leczonych z powodu chromania

Pacjenci leczeni z powodu chromania przestankowego (patients treated for claudicationI)

Poziom anatomiczny (anatomical level)

Aortalno-biodrowy
(aorto-iliac)
n (%)

Udowo- podkolanowy
(femoro-popliteal)
n (%)

Poniżej kolana
(BTK)
n (%)

Ogółem
(total)
n (%)

Pacjenci (patients)

193

165

71

429

Kończyny (legs)

246

173

73

492

Wyniki leczenia po 6 miesiącach od zabiegu (results after 6 months follow-up)

Pierwotny sukces
# (primary success)

210 (85.4)

147 (85)

55 (75.3)

412 (83.7)

Brak poprawy (no change)

24 (9.7)

23 (13.3)

10 (13.7)

57 (11.6)

Niepowodzenie (primary failure)*

4 (1.6)

3 (1.7)

8 (10.9)

15 (3)

amputacja

0 (0)

0 (0)

1 (1.4)

1 (0.2)

reinterwencja

3 (1.2)

3 (1.7)

6 (8.2)

12 (2.4)

pogorszenie

1 (0.4)

0 (0)

2 (2.7)

3 (0.6)

zgon (death)

5 (2)

0 (0)

1 (1.4)

6 (1.2)

Brak kontaktu (lost to follow up)

3 (1.2)

0 (0)

0 (0)

3 (0.6)

Zaawansowanie niedokrwienia 6 miesięcy po zabiegu (severity of ischemia At 6 months)

Kończyny bez KNK (legs without CLI)

237 (99.6)

173 (100)

69 (97.2)

479 (99.4)

Kończyny z KNK (legs with CLI)

1 (0.4)

0 (0)

2 (2.8)

3 (0.6)

#primary success — reduction of the ischemia by at least 1 according to the Rutherford classification without reintervention or amputation; *exacerbation/therapy failure was defined as exacerbation of the ischemia by at least 1 stage according to the Rutherford classification, need of revascularization or amputation

There were 26 limb amputations in the CLI group (7.6% – 10 below the knee and 16 above the knee). There was 1 above the knee amputation in the non-CLI patient (0.2%; p < 0.001).

There were 50 endovascular and no surgical reinterventions beyond the perioperative period (6%) — 38 in the CLI (11.1%) and 12 in the IC group (2.4%, p = 0.002). In 4 CLI patients a staged, combined — percutaneous and surgical — procedures were performed: initially a percutaneous treatment within the aorto-iliac segment was undertaken which was later supplied by a surgical reconstruction of common femoral and/or profunda femoris artery. In 11 limbs an exacerbation of the ischemia (despite reintervention in 3 cases) was noted (1.3%) – 8 in the CLI (2.3%) and 3 in the IC patients (0.6%; p < 0.001). The severity of ischemia did not change in 127 limbs (15.2%) – 70 in the CLI (20.5%) and 57 in the IC patients (11.6%; p < 0.001).

A significant improvement of the ABI was observed for the whole group of patients (0.5 ± 0.33 v. 0.8 ± 0.34, p < 0.01). There were no differences in the ABI improvement between CLI and IC patients.

Figure 3. VascQOL dimensions mean scores ± SD before (light tan) and after 6 months of treatment (dark tan) in CLI patients
Rycina 3. Średnie wartości dla wymiarów VascQOL ± odchylenie standardowe przed (jasny odcień) i 6 miesięcy po zabiegu (ciemny odcień); chorzy z krytycznym niedokrwieniem kończyn

Figure 4. VascQOL dimensions mean scores ± SD before (light tan) and after 6 months of treatment (dark tan) in IC patients
Rycina 4. Średnie wartości dla wymiarów VascQOL ± odchylenie standardowe przed (jasny odcień) i 6 miesięcy po zabiegu (ciemny odcień); chorzy z chromaniem przestankowym (IC)

Quality of life increased significantly for the whole population of patients at 6 month follow. Significant improvement was noted for each domain evaluated by vascular specific form – VascQoL questionnaire and for most of the domains evaluated by the generic form – EuroQuol questionnaire. No significant improvement was seen in the self-care dimension for both CLI and non-CLI patients and in usual activity dimension for non-CLI patients as of EuroQuol assessment (fig. 3−6, tab. 6, 7).

Freedom from major adverse cardiovascular events (MACE) was 74.3% (246/331) in the CLI patients and 92% in the non-CLI patients (392/426; p < 0.001).

Amputation-free survival was 86.4% in the CLI patients (285/331 patients) and 98.4% in the non-CLI patients (418/429 patients; p < 0.001) (fig. 7). Freedom from all-cause death (probability of survival) was 92.4% for CLI and 98% for IC patients. Freedom from clinically driven revascularization was 94% (88%) for CLI and 97.5% for IC patients).

Figure 5. EuroQuol dimensions mean scores ± SD before (light tan) and after 6 months pf treatment (dark tan) in CLI patients
Rycina 5. Średnie wartości dla wymiarów EuroQuol odchylenie standardowe przed (jasny odcień) i 6 miesięcy po zabiegu (ciemny odcień); chorzy z krytycznym niedokrwieniem kończyn

Figure 6. EuroQuol dimensions mean scores ± SD before (light tan) and after 6 months of treatment (dark tan) in IC patients
Rycina 6. Średnie wartości dla wymiarów EuroQuol ± błąd standardowe przed (jasny odcień) i 6 miesięcy po zabiegu (ciemny odcień); chorzy chromaniem przestankowym

Conclusion

Endovascular treatment of peripheral arterial occlusive disease in a 6 month observation provides satisfactory results and is safe. Results in claudicants are significantly better than in patients with CLI.

In IC, the primary success at 6 months (i.e. improvement without re-intervention) was seen in 83.7% while failure of primary treatment was seen in 3% of patients. Periprocedural serious adverse events (SAE) were noted in 1.3% procedures, and at 6 months the MACE was recorded in 8% of patients. There was a single major amputation performed at 6 months in a patient treated endovascularly for a stenosis of a femoro-popliteal by-pass graft. The patient has not come to any of the follow-up visits and lost his leg some 6 month after the PTA (information via the phone call). Overall, the amputation free survival in claudicants was 98.4%.

Table VI. Quality of life before and 6 month after treatment as of disease — specific VascQOL questionnaire assessment (mean ± SD).
Tabela VI. Jakość życia przed i 6 miesięcy po leczeniu w ocenie na podstawie kwestionariusza swoistego dla schorzenia VascQOL (średnia ± odchylenie standardowe)

Domain (domena)

Przed leczeniem
(before treatment)

Po 6 miesiącach
(after 6 months)

Wskazania do leczenia
(indication for treatment)

Pain (ból)

2.2 ± 1.2 
3.4 ± 1.4

3.7 ± 1.4*
4.5 ± 1.5*

CLI
IC

Symptoms (objawy)

2.4 ± 1.2
3.8 ± 1.9

4.0 ± 1.3*
4.8 ± 1.3*

CLI
IC

Social (funkcje społeczne)

2.6 ± 1.5 
3.5 ± 1.9

3.9 ± 1.7*
4.8 ± 1.8*

CLI
IC

Activity (aktywność )

2.1 ± 1.0 
3.1 ± 1.3

3.6 ± 1.3*
4.3 ± 1.4*

CLI
IC

Emotions (emocje)

2.5 ± 1.2 
3.8 ± 1.5

4.1 ± 1.5*
5.0 ± 1.4*

CLI
IC

Total (łącznie)

2.3 ± 1.0 
3.5 ± 1.3

3.8 ± 1.3*
4.7 ± 1.4*

CLI
IC

Asterix denotes significance of the difference at p < 0,05; CLI — critical limb ischemia, IC — intermittent claudication

Table VII. Quality of life before and 6 month after treatment as of a generic EuroQuol questionnaire assessment (mean ± SD)
Tabela VII. Jakość życia przed i 6 miesięcy po leczeniu w ocenie na podstawie kwestionariusza ogólnego EuroQuol (średnia ± odchylenie standardowe)

Domain (domena)

Przed leczeniem
(before treatment)

Po 6 miesiącach
(after 6 months)

Wskazania do leczenia
(indication for treatment)

Mobility (poruszanie)

2.1 ± 0.4 
1.9 ± 0.3

1.9 ± 0.4*
1.8 ± 0.5*

CLI
IC

Self-care (samoopieka)

1.6 ± 0.6 
1.2 ± 0.4

1.6 ± 0.6 
1.3 ± 0.5

CLI
IC

Usual activities
(codzienna aktywność)

2.1 ± 0.6

1.7 ± 0.6

1.8 ± 0.6*

1.6 ± 0.6

CLI

IC

Pain (ból)

2.4 ± 0.5

2.1 ± 0.5

2.0 ± 0.5*

1.8 ± 0.5*

CLI

IC

Depresion/anxiety (depresja/lęk)

2.2 ± 0.5

1.9 ± 0.6

1.9 ± 0.5*

1.6 ± 0.6*

CLI

IC

Visual analogue scale
(wizualna skala analogowa)

42.6 ± 19

52.1 ± 19.2

57.7 ± 19*

63.2 ± 19.7*

CLI

IC

Asterix denotes significance of the difference at p < 0.05; CLI — critical limb ischemia, IC — intermittent claudication

In CLI the primary success at six months was noted in 54% and failure of primary treatment in 19.7% of treated limbs. Periprocedural SAE were seen in 6.9%. At 6 months the amputation free survival was 86.4% and freedom from the MACE was 74.3%.

Figure 7. Amputation free survival; dashed line — patients treated for critical limb ischemia (CLI), solid line — patients treated for claudication (IC)
Rycina 7. Przeżycie bez amputacji; linia przerywana — chorzy leczeni z powodu krytycznego niedokrwienia kończyn (CLI), linia ciągła — chorzy leczeni z powodu chromania przestankowego (IC)

A significant improvement in disease-specific and generic measures of the quality of life was noted in both claudicants and CLI patients.

In as many as 28.7% of the CLI-patients ischemic leg ulcers or necroses could not be cured within the 6 month observation period, meaning the CLI was not eliminated even though the success in the angiographic evaluation had been obtained in 95.3% of procedures. Inability to heal the trophic lesions commonly occurred despite the fact that patients commonly reported a marked decrease of pain intensity after the procedure. The cause of the treatment failure – inability to cure the leg ulcers in these cases could be suboptimal treatment of the lesions resulting from a limited access to units which provide specialised treatment of chronic wounds. To achieve optimal results in trophic lesion treatment it is necessary to provide complex therapy i.e. wound surgery, plastic surgery, orthopaedic surgery, podiatric aid, physical therapy and proper medical treatment. Observation from centres in other countries show that the best results in CLI therapy are achieved when patients are treated in interdisciplinary clinics which offer such complex approach to treatment [9−11].

Data reported in the literature show that surgical treatment of PAOD is more risky and in short term less effective than endovascular therapy. Reported perioperative mortality in CLI surgical treatment is 3.5–5.5%. Also, perioperative amputation rate, reintervention rate and the rate of cardiovascular incidents i.e. ACS, TIA or stroke exceeds respective complication rates presented herein and both surgical and endovascular treatment effects are very much superior to the effects of conservative treatment [12−15]. It should, however, be kept in mind, that only randomized trials, and ensurance of equal distribution of complication risk factors in both arms of o trial – surgical and endovascular – together with a longer observation period may provide a valuable comparison of both treatment modalities. The reported long term observations show that surgery provides better late effects than percutaneous interventional therapy [12−15].

Safety and effects of treatment were dependent on the anatomical location of the lesions. The results obtained from the procedures performed on the aorto-illiac segment are better than in the femoro-popliteal segment, while these, in turn, were better than the results obtained from procedures performed in the infrapopliteal segment. However, it should be kept in mind, that because of the accepted definition of the level of procedure, the category of infrapopliteal procedures includes many multilevel interventions, thus patients with the most advanced lesions in blood vessels. Likewise, the category of femoro-popliteal interventions includes procedures performed on both iliac arteries and the arteries located between the inguinal ligament and the popliteal artery trifurcation.

Noticeable is the low frequency of emergency open vascular surgeries performed to treat complications of endovascular procedures which were not amenable by endovascular treatment (2 cases — 0.4%). While complications which required treatment occured in 38 cases, they were in 36 cases effectively treated by endovascular means, usually during the index procedure. Results of subsequent observations [4, 16, 17] question the reasoning behind the requirement for an obligatory presence of on-site vascular surgery unit at each centre performing endovascular treatment for PAOD [18]. Our findings are in common with conclusions drawn from an analysis of outcomes of percutaneous cardiac interventions (PCI) at hospitals with and without on-site cardiac surgery [19], which on o group of 18,867 PCI cases has convincingly shown, that cardiac surgery back-up has nothing to offer in terms of safety of the PCI. It is worth adding that not a single patient that we have treated required an immediate surgery.

The number of periprocedural acute coronary syndromes was higher than the number of periprocedural vascular surgeries. Hence, it seems that for a unit dealing with percutaneous PAOD treatment it would be more reasonable to collaborate more closely with units which perform PCI , and our observations should be taken into account by those who are responsible for effecting the quality in medicine. What needs to be emphasized here is that providing high efficiency of endovascular complication treatment requires high qualifications of the staff and a wide range of special equipment without which the effective treatment of complications would not be possible.

The observation was performed in a centre which has the largest tradition in endovascular treatment of PAOD in south-eastern Poland and which performs around 60% of all endovascular procedures in Małopolska, a region inhabited by 3.3 million people. Therefore the results presented here may be used to draw conclusions on both the structure of procedural requirements as well as on results which may be obtained in treatment of PAOD by means of endovascular therapy.

The post-procedure observation was limited to a short period of time. One may expect more cases of restenosis/reoclussion in the oncoming months and more cases in need for a re-intervention, thus making the late effects of treatment less favourable.

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