ABSTRACT
PURPOSE: This study was designed to assess the effect of calcium on the efficacy of DEB during revascularization of steno-obstructive SFA lesions. METHODS: Sixty patients with de novo lesions of the superficial femoral artery underwent endovascular treatment with drug eluting balloons (DEB). DEB was selected according to vessel reference diameter (1:1). In case of residual stenosis > 50 % or flow-limiting dissection, postdilatation with conventional balloon or provisional stenting was done. Patients were classified into eight groups according to circumferential distribution of calcium on CT-angiography axial images (from 0° to 360°) and to its length (length < or > 3 cm) evaluated with digital-subtraction-angiography. Ankle-brachial index (ABI), late lumen loss (LLL), target lesion revascularization (TLR), primary (PP) and secondary (SP) patency, major adverse events (MAE), and Rutherford shift were evaluated at 1-year follow-up and correlated with the amount of calcium. RESULTS: Revascularization was successful in all cases. Flow-limiting dissection occurred in five cases (8.3 %) with a higher circumferential degree of calcium and solved in three cases with postdilatation and in the other two with provisional stenting. DEB effect was lower in patients with higher degree of calcium (>270° vs. <90°): ABI 0.71 ± 0.07 versus 0.92 ± 0.07; LLL 0.75 ± 0.21 versus 0.45 ± 0.1; PP 50 versus 100 %; SP 50 versus 100 %; TLR 25 versus 0 %; MAE 25 versus 0 %. CONCLUSIONS: Calcium represents a barrier to optimal drug absorption. Circumferential distribution seems to be the most influencing factor with the worst effect noticed in 360° calcium presence.
Subject(s)
Angioplasty, Balloon/instrumentation , Arterial Occlusive Diseases/blood , Arterial Occlusive Diseases/therapy , Calcium/blood , Drug Carriers , Endovascular Procedures , Femoral Artery , Peripheral Vascular Diseases/blood , Peripheral Vascular Diseases/therapy , Aged , Angiography , Arterial Occlusive Diseases/diagnostic imaging , Female , Humans , Limb Salvage , Lower Extremity/blood supply , Lower Extremity/diagnostic imaging , Male , Middle Aged , Peripheral Vascular Diseases/diagnostic imaging , Stents , Treatment Outcome , UltrasonographyABSTRACT
AIM: The aim of the present paper was to make a report of the 12-month clinical outcomes of the DEBELLUM (Drug-Eluting-Balloon-Evaluation-for-Lower-Limb- mUltilevel-treatMent) randomized trial. METHODS: From September 2010 to March 2011, 50 patients were randomized between drug eluting balloon (DEB, N.=25) and conventional angioplasty balloon (PTA, N.=25). Patients were symptomatic for claudication and critical limb ischemia, with de novo stenosis or occlusion in the femoropopliteal (SFA) and infrapopliteal (BTK) region. Only in the SFA primary stenting was allowed and postdilatation performed with DEB or PTA depending on the assigned group. RESULTS: One hundred and twenty-two lesions were treated: 92 (75.4%) SFA, 30 (24.6%) BTK. Twenty (40%) patients presented multilevel concomitant femoropopliteal and infra-popliteal lesions. Late lumen loss (LLL) was 0.64±0.9 mm in DEB group vs. 1.81±0.1 mm in the control group (P=0.01). In non-stented segment LLL was 0.63±0.9 mm (DEB) vs. 1.70±0.6 mm (PTA), P<0.01. In the stent subgroup was LLL 0.65±0.2 mm (DEB) vs. 1.91±0.3 mm (PTA), P<0.01. In the femoropopliteal region the overall LLL was 0.61±0.8 mm for DEB vs. 1.84±0.3 mm for PTA (P=0.02). BTK the overall LLL was 0.66±0.9 mm (DEB) vs. 1.69±0.5 mm (PTA) (P=0.03). The overall TLR was 12.2% for DEB and 35.3% for PTA (P<0.05). Amputation rate was 4% (DEB) vs. 12% (PTA), P=0.36. Thrombosis was 4% (DEB) vs. 8% (PTA), P≥0.05. Major adverse events 24% (DEB) vs. 60% (PTA), P<0.05. ABI improved more in the DEB group: 0.81±0.3 vs. 0.68±0.13 (P=0.02). Fontaine stage increased (from II b to I) 80% DEB vs. 56% PTA (P<0.05). CONCLUSION: Results confirm and reinforce initial 6-month outcomes. In.Pact DEB balloons can be considered efficient to reduce restenosis rate.
Subject(s)
Angioplasty, Balloon/instrumentation , Cardiovascular Agents/administration & dosage , Drug Carriers , Femoral Artery , Intermittent Claudication/therapy , Ischemia/therapy , Lower Extremity/blood supply , Peripheral Arterial Disease/therapy , Popliteal Artery , Vascular Access Devices , Aged , Aged, 80 and over , Amputation, Surgical , Angioplasty, Balloon/adverse effects , Ankle Brachial Index , Critical Illness , Equipment Design , Female , Femoral Artery/physiopathology , Hemodynamics , Humans , Intermittent Claudication/diagnosis , Intermittent Claudication/physiopathology , Ischemia/diagnosis , Kaplan-Meier Estimate , Limb Salvage , Male , Middle Aged , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/physiopathology , Popliteal Artery/physiopathology , Risk Factors , Rome , Thrombosis/etiology , Time Factors , Treatment Outcome , Vascular PatencyABSTRACT
Renal angiomyolipoma (AML) is a benign mesenchymal tumour. AML often leads to haemorrhagic complications such as retroperitoneal haematoma. Treatment varies from case to case, ranging from minimally invasive approaches such as selective embolization of the renal artery to invasive wedge resection, partial nephrectomy or, in more severe cases, radical nephrectomy. Here we report a case of retroperitoneal haematoma secondary to AML, treated with conservative approach by super-selective embolization of the lower-pole segmental renal artery.
