Clinical and technical aspects in the multidisciplinary management of peripheral arterial disease: limb salvage by means of integrated care strategy with percutaneous angioplasty in the treatment of critical limb ischemia

INTRODUCTION AND AIM OF THE STUDY: Percutaneous transluminal angioplasty (PTA) has revolutionized the management of peripheral arterial disease. Even in the setting of critical limb ischemia (CLI), similar outcomes have been obtained when PTA and bypass surgery are compared. With PTA, local anesthesia can be used, hospital stay is shorter, and morbidity and mortality rates may be lower. The best results may be achieved when the revascularization with PTA is a part of a strategy of integrated care. Aim of this study was to assess the feasibility of this strategy and to evaluate the mid-term results, mainly in terms of mortality, limb salvage (LS), progression of disease (DP), and need of further revascularizations. METHODS: Between January 2007 and June 2008, 105 patients with 137 critical arterial lesions (137 limbs) underwent elective PTA for CLI in one single centre (Clinique Pasteur – Toulouse – France). The decision to perform PTA was jointly considered by vascular specialist, interventional cardiologist and vascular surgeon. Arterial lesions were codified according to TASC classification, and the arterial tree was categorized into three groups: the aorta and iliac arteries (A-I), the common, superficial and profunda femoral arteries (Fem), and the popliteal and tibial arteries (Pop-Tib). Clinical follow-up was obtained for all patients by office visit or direct telephone call. Periodical non-invasive assessment with duplex ultrasound was systematically performed at 1, 3 and 6 months. All angiographic controls were ischemia-driven. RESULTS: The mean age was 77±10 years, 59 patients (56.2%) were males and 58 (55.2%) were diabetic. Eighty-nine patients (84.8%) were hypertensive, 57 (54.3%) had dyslipidemia, and 71 (67.6%) had significant renal disease. Ten patients (9.5%) had a previous peripheral graft. History of coronary artery disease (CAD) was present in 35 (33.3%) patients and history of cardiac heart failure in 28 (26.7%). Mean left ventricular ejection fraction (LVEF) was 56±10%. Indication to PTA was rest pain with non-healing ulcer in 96 patients (91.4%) and with gangrene in 9 (8.6%). Mean Hct value was 36±5%, mean C reactive protein (CRP) 41±59 mg/l, mean fibrinogen 4.4±1.2 g/l and mean pro-BNP 2343±4278 pg/ml. Five lesions (3.6%) were included in A-I group, 60 (43.8%) in Fem group, and 68 (49.6%) in Pop-Tib group. In four cases (2.9%) PTA concerned lesions in previous grafts. Concerning TASC classification, lesions were mostly type B3 (71.5%) and type C1 (13.9%). Mean lesion diameter was 5.3±1.7 mm and mean lesion length was 55±32 mm. Balloon angioplasty was performed in 127 (92.7%) lesions and stent implantation was required in 81 (59.1%). Mean stent diameter was 6±1.4 mm and mean stent length was 69±44 mm. Subintimal angioplasty was performed to treat occlusions in 46/77 cases (59.7%). Procedural success was achieved in 125 lesions (91.2%). There were 3 (2.2%) procedural complications and 2 in-hospital death (1.9%). The mean hospital stay was 5.3±4.7 days. Clinical follow-up was available for 100% of patients over a mean of 304±161 days. At follow-up, 26 patients (24.8%) had died, 20 (19%) of them for cardiovascular causes. Twelve patients (11.4%) were amputated, and 7 of them (58.3%) were still alive. LS was achieved in 124 (90.5%) limbs. Target lesion revascularization (TLR) was performed in 12 lesions (8.8%) and DP was found in 19 (13.9%). Continuing CLI was found in 15 patients (14.3%). Independent predictors of mortality were LVEF<60% and a level of plasma fibrinogen?4.3 g/l. TLR was associated with smoking habit, dyslipidemia, a previous peripheral graft, and higher plasmatic levels of pro-BNP. DP was associated with a higher prevalence of CAD, the presence of a significant renal disease and placement of shorter stents. LS was associated with lower plasmatic levels of CRP. CONCLUSIONS: PTA in the treatment of CLI is safe, with favourable in-hospital and mid-term outcomes, especially when considered as a part of a strategy of integrated care. Despite its high mortality rate, partly due to the mean age of the population and the presence of significant comorbidities, the high rate of LS and the low TLR rate underline the role of this reperfusion strategy even in a subset of fragile patients with severe and diffused PAD. Moreover, this data confirms that patients with severe arterial disease are prone to die mostly due to cardiac causes and that inflammatory and infection markers may be useful in the pre-procedural risk stratification.INTRODUZIONE E SCOPO DELLO STUDIO: l’angioplastica transluminale percutanea (PTA) ha rivoluzionato il trattamento dell’arteriopatia periferica. Persino nei casi d’ischemia critica dell’arto (CLI), sono stati ottenuti risultati paragonabili a quelli della chirurgia. La PTA consente l’uso dell’anestesia locale, il periodo di ricovero è più breve, morbilità e mortalità si riducono. I risultati migliori vengono raggiunti quando la rivascolarizzazione con PTA è inserita in una strategia di assistenza globale. Lo scopo di questa tesi era accertare la fattibilità di tale strategia e valutarne i risultati a medio termine, in particolare concernenti la mortalità, il salvataggio dell’arto (LS), la progressione della malattia (DP) e la necessità di nuove rivascolarizzazioni. METODI: Nel periodo tra gennaio 2007 e giugno 2008, 105 pazienti con 137 lesioni arteriose critiche (137 gambe) sono stati sottoposti a PTA elettiva per CLI in uno stesso centro (Clinique Pasteur – Toulouse – France). La decisione di eseguire la PTA era presa congiuntamente dall’angiologo, dal cardiologo interventista e dal chirurgo vascolare. Le lesioni arteriose erano codificate secondo la classificazione della TASC, e l’albero arterioso era stato inoltre suddiviso in tre parti: l’aorta e le arterie iliache (A-I), l’arteria femorale comune, superficiale e profonda (Fem), e le arterie poplitee e tibiali (Pop-Tib). Il follow-up clinico è stato ottenuto tramite visite ambulatoriali o conversazione telefonica. Una valutazione periodica non-invasiva mediante eco-doppler veniva eseguita al primo, terzo e sesto mese dalla procedura. I controlli angiografici venivano eseguiti in caso di persistenza dell’ischemia critica. RISULTATI: L’età media della popolazione studiata era 77±10 anni, 59 pazienti (56.2%) erano maschi e 58 (55.2%) diabetici. Ottantanove pazienti (84.8%) erano ipertesi, 57 (54.3%) affetti da dislipidemia, e 71 (67.6%) avevano una rilevante alterazione della funzione renale. Dieci pazienti (9.5%) erano già stati sottoposti a un precedente intervento chirurgico di bypass. Una storia di malattia coronarica (CAD) riguardava 35 (33.3%) pazienti e 28 (26.7%) avevano un’anamnesi positiva per scompenso cardiaco. La frazione di eiezione ventricolare sinistra (LVEF) media era 56±10%. L’indicazione a eseguire la PTA era la presenza di dolori a riposo associata a ulcere persistenti in 96 pazienti (91.4%) e a gangrena in 9 (8.6%). Il valore medio di Hct era 36±5%, il valore medio di proteina C reattiva (CRP) era 41±59 mg/l, quello di fibrinogeno plasmatico 4.4±1.2 g/l e quello di pro-BNP 2343±4278 pg/ml. Cinque lesioni (3.6%) facevano parte del gruppo A-I, 60 (43.8%) del gruppo Fem, e 68 (49.6%) del gruppo Pop-Tib. In 4 casi (2.9%) la PTA riguardava lesioni in precedenti bypass. Riguardo alla classificazione della TASC, le lesioni erano perlopiù di tipo B3 (71.5%) e di tipo C1 (13.9%). Il diametro medio delle lesioni era 5.3±1.7 mm e la lunghezza media 55±32 mm. La PTA col pallone è stata eseguita in 127 (92.7%) lesioni e il posizionamento di uno stent è stato necessario in 81 (59.1%). Il diametro medio dello stent era 6±1.4 mm e la lunghezza media 69±44 mm. L’angioplastica con tecnica subintimale per il trattamento delle occlusioni è stata utilizzata in 46/77 casi (59.7%). Il successo immediato al termine della procedura è stato ottenuto in 125 lesioni (91.2%). Si sono verificati 2 (1.9%) decessi intra-ospedalieri e 3 (2.2%) complicazioni procedurali. Il tempo medio di ricovero è stato di 5.3±4.7 giorni. Il follow-up clinico è stato possibile nel 100% dei pazienti a una media di 304±161 giorni dalla procedura. Al follow-up, 26 pazienti (24.8%) erano morti, 20 (19%) di essi per cause cardiovascolari. Dodici pazienti (11.4%) erano stati amputati, e 7 di essi (58.3%) erano ancora vivi. Il LS è stato ottenuto per 124 gambe (90.5%). La rivascolarizzazione nel precedente sito della PTA (TLR) è stata eseguita in 12 lesioni (8.8%), e una progressione di malattia è stata riscontrata in 19 (13.9%). La persistenza di CLI è stata rilevata in 15 pazienti (14.3%). Una LVEF