Comparing the impact of the loss of patency between treatment with drug-coated balloon angioplasty and drug-eluting stent placement.

OBJECTIVE: To compare the results of endovascular treatment with drug-eluting stents (DES) and drug-coated balloons (DCB) in atherosclerotic lesions in the femoropopliteal artery, as well as to assess restenotic patterns. METHODS: Clinical data from 617 cases treated with DES or DCB for femoropopliteal diseases were analyzed in this multicenter, retrospective cohort study. From these, 290 DES and 145 DCB cases were extracted by propensity score matching. Outcomes investigated were 1- and 2-year primary patency, reintervention, and restenotic pattern and its impact on symptoms in each group. RESULTS: The primary patency rates at 1 and 2 years in the DES group were superior to those in the DCB group (84.8% and 71.1% vs 81.3% and 66.6%, P = .043), whereas there was no significant difference in freedom from target lesion revascularization (91.6% and 82.6% vs 88.3% and 78.8%, P = .13). Compared with what was measured before the index procedures, exacerbated symptoms, rate of occlusion, and an increase in the occluded length at loss of patency were more frequent in the DES group than in the DCB group. The odds ratios were 3.53 (95% confidence interval, 1.31-9.49; P = .012), 3.61 (1.09-11.9; P = .036), and 3.82 (1.15-12.7; P = .029), respectively. On the other hand, the frequency of an increase in lesion length and requirement of target lesion revascularization were similar between the two groups. CONCLUSIONS: Primary patency was significantly higher at 1 and 2 years in the DES than in the DCB group. However, DES were associated with exacerbated clinical symptoms and complicated lesion characteristics at the point of loss of patency.

Outcomes of embolization procedures for type II endoleaks following endovascular abdominal aortic repair.

OBJECTIVE: The objective of this study was to investigate the mid-term outcomes of embolization procedures for type II endoleak after endovascular abdominal aortic repair, and clarify the risk factors for aneurysm enlargement after embolization procedures. METHODS: This was a retrospective multicenter registry study enrolling patients who underwent embolization procedures for type II endoleaks after EVAR from January 2012 to December 2018 at 19 Japanese centers. The primary end point was the rate of freedom from aneurysm enlargement, more than 5 mm in the aortic maximum diameter, after an embolization procedure. Demographic, procedural, follow-up, and laboratory data were collected. Continuous variables were summarized descriptively, and Kaplan-Meier analyses and a Cox regression model were used for statistical analyses. RESULTS: A total of 315 patients (248 men and 67 women) were enrolled. The average duration from the initial embolization procedure to the last follow-up was 31.6 ± 24.6 months. The rates of freedom from aneurysm enlargement at 3 and 5 years were 55.4 ± 3.8% and 37.0 ± 5.2%, respectively. A multivariate analysis revealed that a larger aortic diameter at the initial embolization procedure and the presence of a Moyamoya endoleak, defined as heterogeneous contrast opacity with an indistinct faint border, were associated with aneurysm enlargement after embolization management. CONCLUSIONS: The embolization procedures were generally ineffective in preventing further expansion of abdominal aortic aneurysms in patients with type II endoleaks after EVAR, especially in patients with a large abdominal aortic aneurysm and/or a presence of a Moyamoya endoleak.

Successful Sac Embolization to Eliminate a Type 2 Endoleak After Thoracic Endovascular Aortic Repair by Penetration of a Vascular Plug Implanted in a Left Subclavian Artery.

PURPOSE: To describe a technique of vascular plug penetration by a guidewire with a heavy tip load for additional embolization of a type 2 endoleak after endovascular aortic aneurysm repair (EVAR). TECHNIQUE: The technique of vascular plug penetration is effective for additional embolization of a type 2 endoleak, when large arteries such as left subclavian artery (LSA) or hypogastric artery remain patent even after the embolization of the vessel has been performed using a vascular plug and are responsible for the endoleak. A tapered guidewire with a heavy tip load enables the penetration of the disk of the plug, followed by introduction of a microcatheter into the endoleak nidus. In the presented case, the technique successfully eliminated a type 2 endoleak in a thoracic aortic aneurysm for which a patent LSA despite the embolization by a vascular plug was responsible. CONCLUSION: The technique of vascular plug penetration allows an access to an endoleak cavity via a vascular plug placed in an aortic side branch for additional embolization of a type 2 endoleak after EVAR.

Drug Eluting Versus Covered Stent for Femoropopliteal Artery Lesions: Results of the ULTIMATE Study.

OBJECTIVE: Stent grafts (SG) and drug eluting stents (DES) have emerged to combat intimal hyperplasia. It remains unclear which type of stent yields superior outcomes in femoropopliteal (FP) arterial lesions. This study compared the clinical data between the VIABAHN SG and the Eluvia DES two years after endovascular treatment. METHODS: In this retrospective multicentre study, 504 cases with a lesion length > 10 cm treated either with SG or DES were analysed. Ankle brachial index (ABI) measurements were conducted before and after the endovascular procedure, and every three months thereafter. When the ABI dropped ≥ 0.15 compared with the baseline value, a duplex ultrasound was conducted to check stent patency. The outcome measures were stent patency rates, freedom from target lesion revascularisation (TLR), stent thrombosis, and acute limb ischaemia (ALI) accompanying loss of patency rates. Propensity score matching (PSM) was performed to adjust for confounding baseline characteristics. RESULTS: PSM extracted 219 limbs in the SG group and 109 limbs in the DES group. Compared with the SG group, the DES group had statistically significantly higher rates of freedom from TLR (86.0 ± 4.2% vs. 73.1 ± 4.8%, p = .040), and ALI accompanying loss of patency (98.9 ± 1.1% vs. 93.5 ± 1.8%, p = .029) at two years. Primary patency (75.9 ± 5.9% vs. 69.5 ± 5.9%, p = .087) and freedom from stent thrombosis (90.4 ± 3.3% vs. 81.2% ± 3.0%, p = .11) were not statistically significantly different. For lesions ≤ 15 cm, primary patency in the DES group was statistically significantly better than the SG group. CONCLUSION: FP lesions treated with Eluvia DES had a higher primary patency rate in lesions ≤ 15 cm, freedom from clinically driven TLR and ALI accompanying loss of patency than the VIABAHN SG.

Efficacy of Multichannel Balloon Angioplasty in Calcified Common Femoral Artery Lesions.

This report describes 7 cases in which multichannel balloon angioplasty was performed for severely calcified common femoral artery stenosis. After the successful passage of a guidewire through the stenosis, another guidewire with a tip load of 12g or 14 g was passed through a different channel inside the calcified plaques, followed by balloon angioplasty via each route. After the procedure, ankle brachial index improved from 0.49 ± 0.23 to 0.89 ± 0.05 on an average, and 6 of the 7 patients had patent arteries at a median follow-up period of 13 months. Multichannel balloon angioplasty offers the promise of being an effective endovascular intervention to expand calcified lesions.

Vessel Calcification as a Risk Factor for In-Stent Restenosis in Complex Femoropopliteal Lesions After Zilver PTX Paclitaxel-Coated Stent Placement.

Purpose: To evaluate the effect of vessel calcification on in-stent restenosis (ISR) after drug-coated stent (DCS) placement in the femoropopliteal segment. Materials and Methods: A retrospective multicenter study was undertaken involving 220 consecutive symptomatic patients (mean age 73.1±8.3 years; 175 men) with femoropopliteal lesions in 230 limbs treated with the Zilver PTX DCS and having duplex surveillance after the endovascular procedures. Mean lesion length was 16.4±9.8 cm (range 2-40); there were 104 (45.2%) total occlusions and 68 (29.6%) in-stent restenoses (ISR). Twenty (8.7%) vessels had no runoff. The majority of lesions (148, 64.3%) were calcified according to the peripheral arterial calcium scoring system (PACSS). Primary patency was evaluated by duplex. Lesions were classified as either PACSS 0-2 (none or unilateral wall calcification) or PACSS 3 and 4 (bilateral wall calcification). Multivariate analysis was performed to identify variables associated with ISR; the results are given as the hazard ratio (HR) and 95% confidence interval (CI). Results: The 1-, 2-, and 5-year primary patency and freedom from clinically-driven target lesion revascularization estimates were 75.9%, 63.6%, and 45.0%, and 84.7%, 73.7%, and 54.2%, respectively. Major amputations were performed on 4 limbs during follow-up. In multivariate analysis, vessel calcification (adjusted HR 1.718, 95% CI 1.035 to 2.851, p=0.036) was significantly correlated with the occurrence of ISR, along with lesion length (adjusted HR 1.041, 95% CI 1.013 to 1.070, p=0.003), and cilostazol administration (adjusted HR 0.476, 95% CI 0.259 to 0.876, p=0.017). Conclusion: This study suggested that bilateral vessel wall calcification was an independent risk factor for ISR in complex femoropopliteal lesions after Zilver PTX DCS placement, along with lesion length; cilostazol administration had a protective effect.

Coil-In-Plug Technique Using the Amplatzer Vascular Plug II to Occlude a Portosystemic Shunt.

INTRODUCTION: The family of Amplatzer Vascular Plugs (AVPs) is characterized by their precise deployment and high resistance to migration. However, a risk of recanalization of the embolized vessels has been reported. To augment the effectiveness of embolization, the coil-in-plug (CIP) technique was developed, exclusively using AVP I or IV. However, these plugs cannot be used for large vessels like portovenous shunt because of the size limitation. AVP II has a larger-sized model up to 22 mm. This article reports two cases of embolizing high-flow and large-caliber portosystemic shunts where the CIP technique with multilayer AVP II was effectively employed. MATERIALS AND METHODS: The CIP technique using AVP II was utilized for one case with a portocaval shunt and another with a splenorenal shunt. CIP was established with wire penetration through the multilayer meshes, followed by a microcatheter insertion. After the microcatheter was positioned in the central lobe, the internal space was embolized tightly using pushable or detachable coils. RESULTS: A use of guidewire with a high tip load enabled an establishment of CIP and complete occlusion of the target vessels immediately without migration of the embolic devices in both cases. The symptom of encephalopathy improved after the procedure in both the case of the portocaval and the splenorenal shunt. CONCLUSION: The CIP technique with the AVP II was safe and effective to achieve complete occlusion of the large-caliber portosystemic shunts.

Penetration of Dissected Membrane for False Lumen Embolization in a Case of Chronic Aortic Dissection.

Background: Patent false lumens carry a high risk of aortic events including rupture. False lumen embolization is a useful method to promote thrombosis of false lumen. In the case presented here, direct penetration of the dissected membrane was employed to obtain access to the false lumen, enabling embolization. Case report: The case was a 64-year-old female who developed a Stanford type A acute aortic dissection. Replacement of ascending aorta and aortic arch with frozen elephant trunk technique was performed. After the operation, there was a residual flow through the false lumen in the descending thoracic and abdominal aorta. Twenty months later, the patient complained of sudden back pain, and a CT scan demonstrated another new dissection at the distal edge of the open stent. Additionally, the false lumen that had remained since the onset of the type A aortic dissection enlarged during the observation period. An endovascular procedure was planned to exclude the false lumen. Despite closing all communicating channels between true and false lumen using a vascular plug, coils, and stent grafts, the false lumen continued to expand due to the residual flow at the visceral segment. The origin responsible for the flow was not identified. To perform an embolization of the false lumen, access into the false lumen was obtained by penetration of the dissected flap using a trans-septal needle. Following the successful penetration of the flap, embolization of the false lumen was performed using coils and glue. After the embolization, an angiogram of the false lumen confirmed the significant reduction of leakage into the true lumen. The size of the aorta and false lumen decreased after the embolization. Conclusion: Direct penetration of the dissected membrane of the aorta was a safe and useful measure for regaining access to the false lumen and for the following endovascular intervention.

Balloon-oriented puncture for creating an access for endovascular aortic aneurysm repair in a case of iliac and femoral artery occlusion.

BACKGROUND: Abdominal aortic aneurysms (AAA) with iliac artery occlusive diseases are not uncommon. When an occlusion extends from iliac artery to common femoral artery (CFA), adjunctive procedures such as endareterectomy of CFA and angioplasty of iliac artery are performed prior to endovascular aneurysm repair (EVAR). Alternatively, aorto-uni-iliac stentgrafting with femoro-femoro bypass surgery could be performed. If run off vessels such as superficial femoral artery (SFA) and profunda femoris artery (PFA) are both occluded in addition to the CFA, surgical procedures may become extremely complex, with much longer procedure time. We present an unusual case of AAA with arterial occlusion ranging from external iliac artery (EIA) to superficial and profunda femoris arteries, which was fully managed with endovascular means. CASE PRESENTATION: The patient was a 76 year old male who was found incidentally to have a fusiform infrarenal AAA, the size of which was 55 mm in maximal transverse diameter. Despite the occlusions of left EIA, CFA and proximal parts of SFA and PFA, he did not have ischemic symptoms in his left leg due to the development of abundant collateral networks from left internal iliac artery. The patient had a past history of endarterectomy of left CFA. Since a repeated endarterectomy or interposition grafting of the CFA were deemed extremely difficult, without any patent runoff vessel, EVAR was performed using the occluded vessel simply as a conduit for the delivery of the endograft, without revascularizing the vessel. An angioplasty balloon was delivered from right CFA to the occluded left CFA through a subintimal space. A percutaneous puncture of the expanded balloon was done at the occluded left CFA under fluoroscopy, inserting the guidewire into the punctured balloon, finally establishing the through and through wire. EVAR was successfully performed using AFX unibody stentgraft without any complication. CONCLUSION: AAA with access vessel occlusions from EIA to SFA was successfully treated with EVAR with the aid of the balloon oriented percutaneous puncture technique. Having the technique as an armamentarium can broaden the application of EVAR for AAA with the complicated access.

Multicentre randomised controlled trial to evaluate the efficacy of pre-emptive inferior mesenteric artery embolisation during endovascular aortic aneurysm repair on aneurysm sac change: protocol of Clarify IMA study.

INTRODUCTION: Type II endoleak (EL) is frequently seen after endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA) and is often considered responsible for aneurysm sac enlargement if it persists. In order to reduce type II EL and consequent sac enlargement, pre-emptive embolisation of the inferior mesenteric artery (IMA), which is a main source for persistent type II EL, has been introduced in many vascular centres. At present, there is a lack of robust evidence to support the efficacy of pre-emptive embolisation of IMA on reduction of persistent type II EL with subsequent sac shrinkage. METHOD AND ANALYSIS: This multicentre, randomised controlled trial will recruit 200 patients who have fusiform AAA ≥50 mm/rapidly enlarging fusiform AAA, with patent IMA, and randomly allocate them either to a pre-emptive IMA embolisation group or non-embolisation control group in a ratio of 1:1. The primary endpoint is the difference of aneurysm sac volume change assessed by CT scans between the pre-emptive IMA embolisation group and the control group at 12 months after EVAR. The secondary endpoints are defined as change of aneurysm sac volume in both groups at 6 and 24 months, freedom from sac enlargement at 12 and 24 months after EVAR, prevalence of type II EL at 1, 6, 12 and 24 months evaluated by contrast-enhanced CT, reintervention rate, aneurysm related mortality, overall survival, perioperative morbidity, volume of contrast media used during EVAR and dosage of radiation. ETHICS AND DISSEMINATION: The protocol has been reviewed and approved by the ethics committee of Nara Medical University (No. 2113). The findings of this study will be communicated to healthcare professionals, participants and the public through peer-reviewed publications, scientific conferences and the University Hospital Medical Information Network Clinical Trials Registry home page. TRIAL REGISTRATION NUMBER: UMIN000035502.

Spontaneous Collapse of Balloon Expandable Stent in Heavily Calcified Aorta.

Balloon expandable stents (BES), which are made of stainless steel, are vulnerable to external compression, leading to deformation or collapse/fracture of the stents. In this report, two cases of complete collapse of BES are presented. In both cases, BES were placed in a heavily calcified aorta and subsequently collapsed without any evidence of external compression. Repeated pulsation of heavily calcified aorta was presumed to be the cause of the stent collapse.