Efficacy of percutaneous transluminal angioplasty in chronic critical limb ischaemia

Abstract

Aim: To determine the one-year efficacy and the health-related quality of life in patients with critical limb ischemia (CLI) treated by percutaneous transluminal angioplasty (PTA). Methods: A prospective, longitudinal, observational study design was employed. All patients with CLI (Rutherford category 4 – 6) booked for PTA between May and December 2017 at the National hospital were invited to take part in the study. Participants were seen pre-PTA for baseline data, and one week, six months and one-year post-PTA to assess the interventional outcome. Study endpoints included the amputation-free survival (AFS), major and minor adverse limb events, major adverse cardiovascular and cerebrovascular events (MACCE), clinical failure endpoint (clinical deterioration or relapse) and haemodynamic failure endpoint (revascularisation or lack to significantly improve ABPI or TBPI). Haemodynamic parameters (ankle brachial pressure index (ABPI), toe brachial pressure index (TBPI) and spectral Doppler waveform analysis were measured at each visit. The peripheral artery disease quality of life (PADQOL) questionnaire was used to determine patient-related outcomes in terms of quality of life (QoL). Results: A total of 30 participants (mean age of 70.9 years old) with rest pain (20%), tissue loss distal to metatarsals (53.3%) and tissue loss proximal to metatarsals (26.7%) were recruited. At one year, the AFS rate was 93.3%, the clinical failure rate was 10.7% and the mean Rutherford category was significantly better (P < 0.001). The clinical improvement was also reflected in the improved trends in the QoL in terms of physical functioning (P = 0.006) and social relationship (P = 0.059). However, these outcomes were not solely due to the PTA intervention but also due to the adjunct treatment required in 60% of the participants post-PTA, where 20% had a major reintervention, 16.7% had a minor reintervention and 40% had a minor amputation. Additionally, 20% of the participants had a cardiovascular disease up to a year post-PTA. The adjunct treatment needed and the consecutive cardiovascular and limb events resulted in deterioration trend in the QoL in terms of fear and uncertainty (P = 0.231). Conclusions: This study highlighted that while PTA conclude good efficacy results and improvement in QoL in terms of physical functioning, the need for adjunct treatment and consecutive limb events in a large proportion of these patients leads to increased fear and uncertainty. Psychological support may be an important aspect which warrants more attention, together with close surveillance of patients after PTA for timely detection of deterioration and further prevention of lower limb events.