Evolving concepts and management of endoleaks after endovascular aneurysm repair: where do we stand in 2019?

In recent years, there has been tremendous progress in endovascular aneurysm repair (EVAR) techniques and devices. This process has seen a change in incidence, risk factors, and treatment of endoleaks as well as in follow-up protocols after EVAR. In particular, recent literature has highlighted new concepts in the evaluation and prevention/treatment of type I and II endoleak after standard EVAR. There is also recent evidence regarding new imaging protocols for follow-up after EVAR, which include magnetic resonance imaging and contrast-enhanced ultrasound. This comprehensive review aims to outline the most recent concepts on imaging follow-up, pathophysiology/risk factors, and management of endoleaks.

Drug coated balloons in BTK - just too early?

Patients with infra-popliteal arterial disease are generally considered challenging due to the usual presence of multi-vessel atherosclerotic disease. Several treatment options have been used by different authors but none of them can be considered ideal. In the last few years drug coated balloons have gained popularity especially due to the extraordinary results in the femoro-popliteal region. Following the great success, phisicians started to use this promising device also in the below-the-knee (BTK) region. The initial enthusiasm correlated to some studies is not confirmed by the largest randomized trial, IN.PACT Deep, comparing In.Pact DCB vs. standard PTA. This trial failed completely to show the superiority of DCB.The negative outcome was mainly correlated to safety issues with an amputation rate higher for the drug coated balloon when compared to the conventional balloon (8.8% DCB vs 3.6% PTA, p=0.08). A thorough evaluation has been performed to justify these negative outcomes, given the good results reported by other studies. But nowadays is still difficult to find a clear explanation. Especially for this negative outcome and for the big difference, in term of results, beteween the different studies in the BTK region and also betwenn the above and below the knee regions more trials are mandatory.

Retrograde recanalization of complex SFA lesions indications and techniques.

Femoro-popliteal segment is often characterized by diffuse and severe steno-obstructive atheroclerotic disease. Most recent guidelines recommended endovascular techniques as a valid and safe treatment in highly symptomatic patients (Rutherford class 4 to 6) with complex femoropopliteal lesions (TASC C and D). Continuous technical development is increasing the efficacy of the endovascular technique with the introduction of new dedicated devices. In most complex situation also retrograde recanalization can be applied. The main indication to this technique is when conventional antegrade recanalisation fails or cannot be apply. The most common retrograde access is through the popliteal artery. However many operators do not like this approach due to the technical issue correlated to the patient position. Recently several reports have been published keeping the patient supine improving patient comfort and operator activity. This tehnique was also affected by several complications at the level of the popliteal puncture site, but those were resolved with the improvement of technique and operator skills. Hence several Authors described different variants of such technique (subintimal techniques, patient in supine position, puncture of the distal superficial femoral artery, tibial/pedal artery access) all obtaining an high rate of success with a low complication rate. In conclusion retrograde recanalization can be considered a safe and effective technique for complex femoral lesions. It is also less expensive than recanalisation devices, less time consuming and can increase the outcome due to the higher percentage of intraluminal recanalization.

Drug-coated balloons and drug-eluting stents: clinical effectiveness revisited.

Critical limb ischemia (CLI) is a common and devastating manifestation of peripheral arterial disease leading to ischemic rest pain, ulcerations, gangrene and tissue loss. Thus advanced endovascular techniques have been developed in order to achieve higher success rate, such as retrograde recanalisation and drug eluting devices. However, the correlation between patency of the vessels and clinical outcome (limb salvage, ulcer healing, Rutherford class improvement) is still debated. We reviewed the most recent trials and studies investigating the clinical effectiveness of drug eluting stents and balloons for the treatment of CLI.

Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease.

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.

The "DEBELLUM"--lower limb multilevel treatment with drug eluting balloon--randomized trial: 1-year results.

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.