Fractional flow reserve in below the knee arteries with critical limb ischemia and validation against gold-standard morphologic, functional measures and long term clinical outcomes.

Abstract

INTRODUCTION: The aim of this study was to assess the applicability of fractional flow reserve measurement (FFR) in below-the-knee (BTK) arteries and to evaluate its correlation with non-invasive functional parameters before and after angioplasty. METHODS: We enrolled 39 patients with severe BTK arterial lesions. Inclusion criteria were critical limb ischemia (Rutherford 4-6) and angiographically proven arterial stenosis of the distal lower limb (percent diameter stenosis >/=70%). Exclusion criteria were chronic total occlusion, diabetic foot syndrome and non-viable distal lower limb. The transstenotic distal/proximal pressure ratio was measured under resting (Pd/Pa) and hyperemic (FFR) conditions induced by 40mg intra-arterial Papaverin and was compared with quantitative angiography-, laser Doppler- and duplex ultrasound-derived measurements before and after percutaneous angioplasty (PTA). RESULTS: Comparing measurements before and after PTA, we found significant improvements in the resting Pd/Pa values (0.79 [0.67-0.90] vs 0.90 [0.85-0.97]; p<0.001) and FFR values (0.60+/-0.19 vs 0.76+/-0.15; p<0.001), respectively. At baseline, Pd/Pa ratio and FFR were significantly albeit weakly correlated with % area stenosis (r:-0.31, p=0.05 and r:-0.31, p=0.05, respectively). After PTA, neither Pd/Pa nor FFR remained correlated with % area stenosis. Similarly, prior PTA, Pd/Pa ratio and FFR were significantly correlated with TcO2% and perfusion unit change (r:0.48, p<0.01 and r:0.34, p<0.05, respectively), but after intervention, these significant correlations vanished. Pd/Pa and FFR values did not show correlation with duplex ultrasound-derived measurements. At 1year, major adverse events (MAEs) and major adverse cardiovascular and cerebrovascular (MACCEs) were observed in 7 (17.9%) and in 9 (23.1%) patients, respectively. CONCLUSION: CLI due to severe BTK arterial disease was associated with several impediments of baseline pressure measurements which were significantly improved after successful PTA and stenting. Significant relationships between pressure data and functional and imaging parameters existed prior intervention but vanished after. Further studies are required to determine the clinical value of pre- and post-PTA pressure measurements in BTK arterial disease.