Is there already a place for endovascular treatment of the common femoral artery?

Surgical endarterectomy has been considered the prefered technique for treating the common femoral artery (CFA). Although favorable endovascular treatment results of the CFA have recently become available, losing the groin area as an important acess site is still the major concern for this technique to become the golden standart. Nevertheless, the endovascular approach has shown, through several studies, including our experience, the capacity to establish itself as a complementery treatment for the modern vascular surgeon.

Early experience with the EntrustTM delivery system for stent treatment of the lower extremities' arteries via transbrachial approach.

AIM: The femoral artery remains the access of choice in the majority of peripheral vascular interventions. However, specific conditions indicate catheterization of the brachial artery. Contrary to balloon catheters, the majority of stent delivery systems are too short to facilitate transbrachial implantation of self-expandable stents (SES) in the superficial femoral artery (SFA). We report our experience with a new 150 cm working length SES-delivery system for transbrachial lower extremity interventions. METHODS: All patients treated with the Entrust(TM) delivery system (EDS) for lower extremity peripheral arterial disease (PAD) via a transbrachial access between December 2012 and February 2014 were included into this study. All data were prospectively collected and analyzed. Primary endpoints were the feasibility and safety of the EDS in the transbrachial setting. Secondary endpoints consisted of stent length accuracy after deployment, early clinical outcome and perioperative complications. RESULTS: Thirty-seven EverFlex(TM) stents with Entrust(TM) delivery system were implanted transbrachially in twenty-eight (N.=28) patients. The transbrachial implantation of a SES using the EDS was feasible in all patients. Stent compression or elongation >10%, premature jumping or movements of the implanted stents were not observed in any patient. Although no stent fractures were observed, a single stent occlusion was noticed. Early clinical success was achieved in all but one patient, with one patient requiring a surgical revision of the puncture site due to pseudoaneurysm. CONCLUSION: The early experience with the new SES-delivery system suggests that EDS enables the safe and effective treatment of the lower extremities PAD via a transbrachial approach. However, further evaluation is needed to define whether the use of the new long shaft stent delivery system influences the performance of the EverFlex(TM) stent in the long run.

New devices for a better endovascular approach.

The endovascular approach has known a great evolution in terms of vessel patency and treatment possibilities. Longer and more complex lesions with a difficult anatomy can be addressed by a range of endovascular tools. However, to maintain the patency of the treated lesion is the true challenge. In order to fulfill these long-term expectations, newer devices have been developed. The drug-coated balloon combines local drug uptake with no residual material after treatment. To maintain patency and prevent recoil of the arterial wall, the drug-eluting stent has been created to offer stent support with an antiproliferative drug. The main drawbacks of the drug-coated balloon and the drug-eluting stent are being addressed by the drug-eluting absorbable scaffold. The initial scaffolding support in combination with the drug release during a prolonged period, poses the same advantages while the scaffold is being metabolized over time. This continuing evolution in endovascular tools paves the way to an endovascular treatment for the majority of peripheral artery diseases.

Midterm results of the transarterial use of Onyx in the treatment of persisting type II endoleaks after EVAR.

AIM: Type II endoleaks with growing aneurysm sac >5 mm in diameter after EVAR require treatment. Different treatment options have been reported. The aim of this study was to evaluate the use of an ethylene-vinyl alcohol copolymer (Onyx) in an endovascular approach. METHODS: Between January 2010 and December 2011, 10 consecutive patients with persistent type II endoleaks leading to aneurysm growth >5 mm were treated in our center by transarterial Onyx embolization by super selective cannulation of the endoleak with microcatheters. Technical success was defined as transarterial Onyx deployment directly into the aneurysm sac. Clinical success was defined as stable or shrinking axial aneurysmal diameter during follow- up using an angiographic computed tomography. RESULTS: Ten patients with 13 persistent type II endoleaks leading to aneurysm sac growth of >5 mm were identified in the time period. Technical success was 92% (12/13 patients). Two patients underwent a staged procedure because several, unconnected type II endoleaks were present. In one patient a cannulation of the inflow vessel responsible for the endoleak was not possible, continued efforts led to a rupture of the hypogastric artery which was treated by covered stent implantation. In one patient an extravasation of onyx out of the aneurysm sac into the inferior vena cava during the embolization process made a transvenous goose snare maneuver necessary to retrieve the dislocated copolymer. No further complications were observed during the mean follow-up of 19.8 months (range, 3-31 months). In all patients with successful embolization the aneurysm sac remained stable or was decreased within the follow-up period. CONCLUSION: Use of Onyx in the endovascular treatment of type II endoleaks after EVAR is feasible, safe when accurately deployed and efficient. Further studies are necessary to evaluate the value of the different treatment modalities (translumbar vs. transarterial).

Drug-eluting technologies in femoral artery lesions.

The treatment of femoropopliteal lesions has known an important evolution in the last years. An important limitation of current endovascular therapy remains the occurrence of restenosis. In order to minimize restenosis rates, drug eluting technologies are evolving. The use of drug-eluting stents (DES) in coronary arteries shows beneficial results, leading to investigation of DES in femoropopliteal arteries. In this article, we give an overview of current available data on treatment with drug eluting technologies in the superficial femoral artery (SFA). This paper summarizes also the current available data of the use of drug-coated balloons (DCB) in the femoropopliteal tract. Currently, no data are available on the use of DCB in long lesions. A drug eluting bioresorbable scaffold seems to be very promising in coronary arteries. The transfer to the peripheral area is nowadays ongoing. Which technique and device for which lesion and patient requires further investigation to build up a real evidence based SFA treatment strategy.

BRAVISSIMO: 12-month results from a large scale prospective trial.

The BRAVISSIMO study is a prospective, non-randomized, multi-center, multi-national, monitored trial, conducted at 12 hospitals in Belgium and 11 hospitals in Italy. This manuscript reports the findings up to the 12-month follow-up time point for both the TASC A&B cohort and the TASC C&D cohort. The primary endpoint of the study is primary patency at 12 months, defined as a target lesion without a hemodynamically significant stenosis on Duplex ultrasound (>50%, systolic velocity ratio no greater than 2.0) and without target lesion revascularization (TLR) within 12 months. Between July 2009 and September 2010, 190 patients with TASC A or TASC B aortoiliac lesions and 135 patients with TASC C or TASC D aortoiliac lesions were included. The demographic data were comparable for the TASC A/B cohort and the TASC C/D cohort. The number of claudicants was significantly higher in the TASC A/B cohort, The TASC C/D cohort contains more CLI patients. The primary patency rate for the total patient population was 93.1%. The primary patency rates at 12 months for the TASC A, B, C and D lesions were 94.0%, 96.5%, 91.3% and 90.2% respectively. No statistical significant difference was shown when comparing these groups. Our findings confirm that endovascular therapy, and more specifically primary stenting, is the preferred treatment for patients with TASC A, B, C and D aortoiliac lesions. We notice similar endovascular results compared to surgery, however without the invasive character of surgery.

The Zilver® PTX® Single Arm Study: 12-month results from the TASC C/D lesion subgroup.

AIM: The aim of the present article was to report the 12-month results of the Zilver® PTX® Single Arm StudyTASC C/D de novo lesion subgroup. METHODS: The Zilver PTX Drug-Eluting Peripheral Stent is a self-expanding nitinol stent with a polymer-free paclitaxel coating. This is a prospective, single-arm, multicentre clinical study evaluating the Zilver PTX Drug-Eluting Peripheral Stent for treating patients with symptomatic lesions in the above-the-knee femoropopliteal artery. This study enrolled 787 patients (900 lesions) with Rutherford class 2 or higher treated with the Zilver PTX stent; 135 were long de novo lesions, corresponding to TASC II Class C or D. RESULTS: The 135 long lesions had a mean length of 226.1±43.6 mm. The 12-month Kaplan-Meier estimates included a 77.6% primary patency rate, an 84.7% event-free survival rate, and an 85.4% rate of freedom from target lesion revascularization (TLR). The 12-month stent fracture rate was 2.1%. CONCLUSION: The primary patency rates in the analysis of the TASC C/D de novo lesion subgroup of the Zilver PTX Single Arm Study indicate that endovascular therapy outcomes with a paclitaxel eluting stent may equal those of bypass surgery. Endovascular treatment with DES may play an important role for treatment of patients who present with TASC C or D femoropopliteal lesions.

Refining stent technologies for femoral interventions.

Stents were created as a mechanical scaffold to prevent vessel recoil and luminal renarrowing after percutaneous transluminal angioplasty (PTA). In femoropopliteal arteries, indication for stent implantation remains a topic much debated on, especially in long lesion configurations. Ever since the first stents were introduced on the market, in-stent restenosis (ISR) has been an important issue. The evolution in stent design has known a major progression in the last decades from the first generation of stents, plagued with high fracture rates and low primary patency rates, to the design of newer stents to tackle these outcomes. More flexible and longer stents decreased the high fracture rates and drug-eluting stents offered a solution to the restenosis rates by local drug application. The difficult recrossibility of the lesion because of the presence of a permanent vascular scaffold is an obstacle that the drug-coated balloon (DCB) overcomes. Future perspectives in the treatment of femoropopliteal lesions are found in the bioresorbable stent implantation. The bioresorbable stent combines the advantages of a drug-eluting scaffolding stent without the remainder of a foreign object in the long-term. Further investigations in this area will eventually evolve in the creation of a superior endovascular treatment modality with high long-term patency rates and minimal detriments.

In lower extremity PTAs intraluminal is better than subintimal.

With subintimal recanalization, a channel is deliberately created by dissecting the vessel wall in order to replace the native occluded lumen. This is opposed to intraluminal recanalization, where passage of an arterial obstructive lesion is performed by central luminal navigation. Both intraluminal and subintimal treatment has its proponents and adversaries. The appreciation of an investigator for a certain technique is commonly related to the training received and the personal experience. Yet, the intraluminal technique uses the clinically preferred route for adjunctive treatment, such as balloon angioplasty or stent deployment. A wide variety of devices designed to obtain intraluminal lesion passage is available and is currently being used in vascular centers worldwide. With intraluminal techniques, success rates of up to 95% have been reported.

Endovascular procedures and new insights in diabetic limb salvage.

Critical limb ischemia (CLI) is affecting an increasing number of patients, mainly due to an ageing population and the growing number of diabetics. Clinically, CLI is characterized by rest pain, non-healing foot wounds and gangrene, due to insufficient arterial blood supply. Limb preservation should be the goal in patients with diabetic foot due to tibial occlusive disease. As surgery is associated with considerable morbidity and mortality rates, endovascular therapy can offer a valuable alternative. Small-diameter below-the-knee arteries that were previously unamenable to surgical methods, can now be reached and treated. Currently, many endovascular techniques are available, from regular PTA and bare metal stents to drug-coated balloons and drug-eluting stents. In our opinion the results of endovascular therapy for below-the-knee vessels will be further improved by the continuous technical evolution and new material developments. In the light of the current evolution towards minimally invasive techniques, an increasing number of experienced centers will be able to treat the vast majority of all below-the-knee arterial pathology by endovascular means.

BRAVISSIMO study: 12-month results from the TASC A/B subgroup.

AIM: The BRAVISSIMO study is a prospective, non-randomized, multicenter, multinational, monitored trial, conducted at 12 hospitals in Belgium and 11 hospitals in Italy. This manuscript reports on the BRAVISSIMO TASC A&B iliac lesion cohort, based on data collected up to the 13-month time point. The primary endpoint of the study is primary patency at 12 months, defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (>50%, systolic velocity ratio no greater than 2.0) and without Target Lesion Revascularization (TLR) within 12 months. METHODS: Between July 2009 and February 2010, a total of 190 patients who presented with TASC A or TASC B aorto-iliac lesions were included, of which 140 patients were enrolled in Belgium and 50 in Italy. RESULTS: The demographic data were comparable for the TASC A and TASC B patients groups. The number of occlusions, the average degree of stenosis, the average lesion length was significantly higher in the group of TASC B lesions, which is congruent with the TASC lesions definitions. Similarly, there were significantly more unilateral lesions in the TASC A group, compared to the TASC B group. The 12-month primary patency rate was 94.0% for TASC A lesions and 96.5% for TASC B lesions, which is not statistically significant. The 12-month primary patency rate was 92.9% in lesions treated with the Omnilink Elite stent, 97.1% in lesions treated with the Absolute Pro stent groups, and 100% in lesions treated with both stents. CONCLUSION: Our findings confirm that endovascular therapy, and more specifically primary stenting, is the preferred treatment for patients with TASC A/B aortoiliac lesions. Currently, we are collecting the 12-month data for the TASC C/D subgroup in the BRAVISSIMO study. Upon release of the results from this subgroup, we will be able to compare the results from both arms of this large-scale international study.

Drug-eluting stents below the knee.

The fear that early thrombosis and late luminal loss due to intimal hyperplasia formation potentially leads to insufficient long-term patency rates can explain the reluctance on implanting stents in small diameter below-the-knee (BTK) arteries. Drug-eluting stent (DES) technology was developed to prevent early thrombosis and late luminal loss to potentially improve long-term patency rates. Currently, the first level 1 evidence from prospective, randomized, controlled DESTINY and ACHILLES studies indicate that the implantation of DES in short lesion lenghts in the infrapopliteal vasculature leads to favorable outcomes with high primary patency rates. This makes that primary DES placement can be recommended as treatment strategy in short BTK-lesions.

Importance of exchange of vascular trainees among centers.

Training in surgery has for a long time been based on the classical model of master-apprentice, leading to the creation of "schools" comparable to the famous painter schools of Rubens, Rembrandt and many others during the Middle Ages. Although it may offer some advantages, this model is no longer suitable today. Modern vascular surgery covers several fields, including not only open vascular and endovascular treatment, but also non-invasive diagnosis and medical treatment of vascular diseases in different parts of the human body. However, the goal of training remains the formation of a "holistic vascular surgeon", with knowledge of and experience in all these areas. As most training centers are more focused on and have more expertise in one or some of these areas, an ideal training curriculum would consist of a rotation between different centers with different points of attention and possibly even rotations in other specialties, such as interventional radiology, vascular medicine or ultrasonography. Such an exchange cannot only be beneficial for the trainee but contact with trainees with a different background can also offer an added value to the training center. Thanks to new ways of communication and transportation, exchange of trainees, even in different countries, has become much easier. Nevertheless, a problem often arises concerning the requirements for training as, despite the many efforts already undertaken, it still differs significantly between different countries. The development of a core-curriculum and mutual recognition of training centers is urgently needed and further steps in the harmonization of training programs and requirements need to be stimulated.

Impact of stent design on the outcome of intervention for carotid bifurcation stenosis.

Over the past several years, there has been continued significant interest in refinement of patient selection, devices, procedures and protocols in an effort to optimize the outcome of percutaneous intervention for carotid bifurcation stenosis, including: ongoing National Institutes of Health and manufacturer trials and registries; the further refinement of existing devices and emergence of new platforms to attain distal embolic protection; ongoing study of what really constitutes a high-risk carotid surgery or stenting patient; and attention to device characteristics and patient-device matching. Within the latter area, considerable interest has focused on stent characteristics that have the potential to impact short and long-term outcome when compared with other stent design strategies when studied in large series. The stent in carotid artery intervention occupies a unique role in that after the embolic protection system has been removed, it is the main line of defense (in concert with aggressive dual antiplatelet therapy) from embolic and thromboembolic complications that may arise from the newly remodeled plaque after post-stent angioplasty. In this review, we aim to update the current status of efforts to relate stent design strategy to outcome in intervention for extracranial carotid artery disease with a focus primarily on the function of "free cell area" (typically lower with closed-cell stents and higher with open-cell stents) in analyses of outcome in carotid artery stenting. Also, the potential role of closed-cell vs. open-cell stent selection in other reports related to carotid artery stenting outcome or complications is reviewed. Rigorous studies have examined the issue of free cell area and arrived at disparate conclusions. Randomized data on the impact of free cell area and cell design strategy on carotid intervention are presently lacking. However, we believe sufficient data and rationale exist 1) to warrant ongoing study of the impact of stent design on outcome in carotid intervention; and 2) to make consideration of closed-cell (low free cell area) stent use a reasonable approach to device selection--when patient factors, lesion characteristics, or device availability make doing so possible.

Prevention and treatment of in-stent restenosis.

In-stent restenosis has always been an important issue, since the launch of the first stents on the market. The occurrence of in-stent restenosis (ISR) is due to two main reasons. First, the presence of stent fractures significantly influences restenosis rates. Second, the continuous interaction between the permanently implanted artificial material and the vessel tissue, leads to physical irritation, long-term endothelial dysfunction, or chronic inflammatory reactions. In the Literature only very limited data on ISR treatment in the peripheral arteries are available. There are no peer-reviewed publications or studies with in-depth follow-up on this specific indication. The underlying reason for this probably being that currently available treatments do not yield satisfactory results. However, the continuing search for better solutions and the technological evolution lead to the introduction of the Viabahn with PROPATEN coating, DES and DCB, which may result in the first promising treatment options for ISR.

The role of carotid artery stenting for recent cerebral ischemia.

Patients with cerebral ischemia as a result of acute cervical internal carotid artery occlusion are generally considered to have a poor prognosis. Despite maximal medical treatment, a better treatment for patients with acute ischemic stroke who present with serious neurologic symptoms on admission or continue to deteriorate neurologically due to a total occlusion, a dissection or a high-grade stenosis of the internal carotid artery is required. An effective intervention to improve their neurologic symptoms and clinical outcome has not yet been established and represents a challenging and complex problem. Treatment of acute symptomatic occlusion of the cervical internal carotid artery includes intravenous administration of thrombolytic agent, carotid endarterectomy and an interventional approach (intra-arterial administration of thrombolytic agent, transluminal angioplasty with or without stenting). The endovascular interventional approach is becoming a part of the stroke therapy armamentarium for intracranial occlusion. It may also now be considered in select patients with acute internal carotid artery occlusion. Stenting and angioplasty for acute internal carotid artery occlusion appears to be feasible, safe and may be associated with early neurological improvement. The encouraging preliminary results await confirmation from prospective, randomized studies.

Endovascular management of acute limb ischemia.

Acute limb ischemia (ALI) refers to a rapid worsening of limb perfusion resulting in rest pain, ischemic ulcers or gangrene. With an estimated incidence of 140 million/year, ALI is serious limb-threatening and life-threatening medical emergency demanding prompt action. Three prospective, randomized clinical trials provide data on trombolytic therapy versus surgical intervention in patients with acute lower extremity ischemia. Although they did not give us the final answer, satisfactory results are reported for percutaneous thrombolysis compared with surgery. Moreover, they suggest an important advantage of thrombolysis in acute bypass graft occlusions. Therefore, we believe thrombolytic therapy should be a part of the vascular surgeon's armamentarium to safely and successfully treat ALI patients.

The use of the cryoplasty technique in the treatment of infrapopliteal lesions for Critical Limb Ischemia patients in a routine hospital setting: one-year outcome of the Cryoplasty CLIMB Registry.

AIM: It was the objective of the Cryoplasty CLIMB to evaluate the effectiveness of the PolarCath device in a standard clinical practice in the treatment of infrapopliteal lesions in critical limb ischemia patients. METHODS: Between May 2007 and July 2008, 100 patients (72 years, 67%male) with CLI were enrolled in the trial for the treatment of 100 infrapopliteal stenoses or occlusions. The mean lesion length and diameter stenosis were 54.9+/-55.8 mm and 91.3+/-8.3%. Primary endpoint was defined as 12-month primary patency based on duplex. Secondary endopoints were immediate success and 12-month limb salvage and survival rate. RESULTS: Multiple cryoplasty cycles were performed in 56 cases (2.1 inflations per patient) and in 4 the use of a different size balloon was required. The immediate technical success rate was 95.0% and the stent rate was 17.0%. The 12 month primary patency, limb salvage and survival rates were 55.9+/-7.4%, 93.8+/-2.5% and 81.8+/-3.9%, respectively. Stratification for lesion length did not show significant outcome differences for lesions < or =50.0 mm and those >50.0 mm neither for primary patency (P=0.94), nor for limb salvage (P=0.32). CONCLUSION: The cryoplasty technique is effective for the treatment of infrapopliteal lesions in CLI patients. The results seem to be within the range of those of conventional PTA. Especially for shorter lesion (<50.0 mm), the wide-spread use of cryoplasty is not recommended. For lesions with a minimal length of 50.0 mm, the results are encouraging.

Carotid endovascular interventions: patient selection, devices, techniques and tips.

The optimal treatment of patients with asymptomatic or symptomatic carotid artery disease (CAD) has been a long-lasting debate. The choice between carotid endarterectomy (CEA), carotid artery stenting (CAS) and/or optimal medical therapy to treat patients with CAD, depends on their risk profile. Recent data from EVA-3S, SPACE randomized trials failed to demonstrate non-inferiority for CAS over CEA. However, other publications suggest that with growing experience and the development of dedicated CAS technology, CAS can be performed safely and efficiently. The success of carotid stenting does not solely depend on the operator's skills and experience, but also on the adequate selection of carotid stents and cerebral protection devices. Currently, CAS practitioners are confronted with a large number of dedicated CAS devices (stents and embolic protection devices). This wide array of products makes individual treatment strategies difficult to generalise as no single device possesses all of the optimal features to treat all types of carotid plaques and patients. This article reviews the principles of patient selection and device selection in contemporary CAS practice.