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.

Hemodynamic evaluation of lower limbs in patients with chronic limb-threatening ischemia.

Revascularization plays an important role in the treatment of chronic limb-threatening ischemia. Evaluation of hemodynamic compromise in the lower extremity is required to optimize the treatment strategy for each patient. A variety of methods have been reported to detect arterial obstruction or impaired foot perfusion. This article reviews each method, clarifying features and limitations.

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.

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.

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.

Direct puncture of an occluded common femoral artery as a new approach for endovascular aortic aneurysm repair.

BACKGROUND: Abdominal aortic aneurysms (AAA) which present with a hostile access are not uncommon. When an arterial occlusion continuously involves from the iliac to the femoropopliteal artery, endovascular aneurysm repair (EVAR) can become complex, necessitating an adjunctive surgical procedure. The present report outlines a successful EVAR which was conducted without any adjunctive surgical procedure for an AAA complicated by extensive access vessel occlusion. CASE PRESENTATION: The patient, an 82-year-old male, had a fusiform 50 mm infrarenal AAA. He had a history of above knee amputation of the right leg due to a gangrene from Buerger's Disease. Despite the continuous occlusions of the right external iliac artery (EIA), common femoral artery (CFA), and superficial femoral and profunda femoris artery, limb ischemia was not observed in his right leg. Since revascularization of the occluded right iliac and femoral arteries was deemed to be too complex technically and no ischemic symptoms were observed, EVAR was performed using the occluded access only for the delivery of the stent graft without restoring the flow. Firstly, the occluded right CFA was punctured under ultrasound guidance. Next, a 0.014 in. guidewire and a microcatheter were successfully navigated to the subintimal space of the right common iliac artery (CIA), these were then exchanged with a reentry device. The reentry device allowed the advancement of a guidewire into the true lumen of the right CIA. Then, a 12Fr sheath for delivery of a contralateral limb was advanced via the occluded right access to aorta, and a 16 Fr sheath for delivery of a main body graft was advanced via a patent left iliac artery. A standard EVAR procedure was subsequently performed. CONCLUSIONS: EVAR was successfully performed for an AAA complicated with an arterial occlusion from the EIA to the SFA using direct puncture of the occluded CFA. This technique could be an effective measure for cases with a hostile access involving the CFA.

Significance of initial hemoglobin levels in severe trauma patients without prehospital fluid administration: a single-center study in Japan.

OBJECTIVES: Hemoglobin (Hb) levels have been considered to remain stable in the early stages of bleeding due to trauma. However, several studies have reported that rapid compensatory fluid shifts cause Hb dilution earlier than previously thought. These reports are from Western countries where it is standard protocol to administer fluids during an emergency, making it almost impossible to eliminate the effect of prehospital intravenous fluid administration on Hb levels. This study aimed to determine the relationship between Hb levels and severity of injury on arrival at the hospital in severe trauma patients without prehospital intravenous fluid administration. METHODS: This single-center observational retrospective study included patients with Abbreviated Injury Scale scores of 3 or above between 2008 and 2014. In Japan, prehospital life-saving technicians were not allowed to administer intravenous fluids until 2014. We investigated whether the difference between the measured blood Hb level at arrival and the corresponding standard blood Hb level for each age group and sex reported in the national survey was associated with the severity of injury and the need for hemostasis. RESULTS: In total, 250 patients were included in this study (median age, 46 years; male patients, 183). The median time from injury to arrival at the hospital was 45 min, and there was no statistical correlation with the initial Hb level on arrival (ρ=0.092, p=0.14). When the study subjects were stratified into four groups according to the initial Hb levels, lower Hb levels correlated with higher rates of requirement for hemostatic interventions (p=0.02) and mortality (p=0.02). In addition, lower Hb levels were associated with the need for hemostasis. CONCLUSION: In severe trauma patients without prehospital intravenous fluid administration, decreased Hb levels on arrival may be associated with the severity of trauma and with the need for hemostasis. LEVEL OF EVIDENCE: Level IV.

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.

Telephone CPR: Current Status, Challenges, and Future Perspectives.

With each successive update of the cardiopulmonary resuscitation (CPR) guidelines, the role of dispatchers in sudden cardiac arrest (CA) has grown. Dispatchers instruct callers in how to perform CPR until the arrival of emergency medical service (EMS) professionals. This is widely known as telephone CPR (TCPR) or dispatch-assisted CPR (DACPR). Studies have shown the efficacy of TCPR in increasing the survival rate of sudden CA. The TCPR process, however, is challenging and needs to be constantly evaluated and refined in order to improve the survival rate of sudden CA victims throughout the world. In this review article, the current status, challenges, and future perspectives of TCPR are discussed with a view to providing a research foundation from which to launch further studies into the effective role of dispatchers in sudden CA.

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.

The effect of 10-min dispatch-assisted cardiopulmonary resuscitation training: a randomized simulation pilot study.

BACKGROUND: Immediate bystander cardiopulmonary resuscitation (CPR) is essential for survival from sudden cardiac arrest (CA). Current CPR guidelines recommend that dispatchers assist lay rescuers performing CPR (dispatch-assisted CPR (DACPR)), which can double the frequency of bystander CPR. Laypersons, however, are not familiar with receiving CPR instructions from dispatchers. DACPR training can be beneficial for lay rescuers, but this has not yet been validated. The aim of this study was to determine the effectiveness of simple DACPR training for lay rescuers. METHODS: We conducted a DACPR simulation pilot study. Participants who were non-health care professionals with no CPR training within 1 year prior to this study were recruited from Nara Medical University Hospital. The participants were randomly assigned to one of the two 90-min adult basic life support (BLS) training course groups: DACPR group (standard adult BLS training plus an additional 10-min DACPR training) or Standard group (standard adult BLS training only). In the DACPR group, participants practiced DACPR through role-playing of a dispatcher and an emergency caller. Six months after the training, all subjects were asked to perform a 2-min CPR simulation under instructions given by off-duty dispatchers. RESULTS: Out of the 66 participants, 59 completed the simulation (30 from the DACPR group and 29 from the Standard group). The CPR quality was similar between the two groups. However, the median time interval between call receipt and the first dispatch-assisted compression was faster in the DACPR group (108 s vs 129 s, p = 0.042). CONCLUSIONS: This brief DACPR training in addition to standard CPR training can result in a modest improvement in the time to initiate CPR. Future studies are now required to examine the effect of DACPR training on survival of sudden CA.

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.

Simplified Endovascular Deep Venous Arterialization for Non-option CLI Patients by Percutaneous Direct Needle Puncture of Tibial Artery and Vein Under Ultrasound Guidance (AV Spear Technique).

The following case report describes the AV spear technique for percutaneous deep venous arterialization. After an ultrasound survey was performed to find the puncture point adjacent to the ankle joint where the posterior tibial vein (PTV) runs superficially to the posterior tibial artery (PTA), percutaneous penetration of the PTV and PTA was conducted. Then a microguidewire was inserted from the distal puncture site into the PTA and advanced into the arterial sheath, establishing a through-and-through wire. A microcatheter was then advanced antegradely over the through-and-through wire. After removing the wire, a hydrophilic guidewire was utilized in order to identify the venous lumen. Finally, a balloon angioplasty was conducted to create an AV fistula, which was reinforced by stent placement.

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.

Quality of dispatch-assisted cardiopulmonary resuscitation by lay rescuers following a standard protocol in Japan: an observational simulation study.

Aim: Bystander cardiopulmonary resuscitation (CPR) is essential for improving the outcomes of sudden cardiac arrest patients. It has been reported that dispatch-assisted CPR (DACPR) accounts for more than half of the incidence of CPR undertaken by bystanders. Its quality, however, can be suboptimal. We aimed to measure the quality of DACPR using a simulation study. Methods: We recruited laypersons at a shopping mall and measured the quality of CPR carried out in our simulation. Dispatchers provided instruction in accordance with the standard DACPR protocol in Japan. Results: Twenty-three laypersons (13 with CPR training experience within the past 2 years and 10 with no training experience) participated in this study. The median chest compression rate and depth were 106/min and 33 mm, respectively. The median time interval from placing the 119 call to the start of chest compressions was 119 s. No significant difference was found between the groups with and without training experience. However, subjects with training experience more frequently placed their hands correctly on the manikin (84.6% versus 40.0%; P = 0.026). Twelve participants (52.2%, seven in trained and five in untrained group) interrupted chest compressions for 3-18 s, because dispatchers asked if the patient started breathing or moving. Conclusion: This current simulation study showed that the quality of DACPR carried out by lay rescuers can be less than optimal in terms of depth, hand placement, and minimization of pauses. Further studies are required to explore better DACPR instruction methods to help lay rescuers perform CPR with optimal quality.

Exendin-4 Prevents Vascular Smooth Muscle Cell Proliferation and Migration by Angiotensin II via the Inhibition of ERK1/2 and JNK Signaling Pathways.

Angiotensin II (Ang II) is a main pathophysiological culprit peptide for hypertension and atherosclerosis by causing vascular smooth muscle cell (VSMC) proliferation and migration. Exendin-4, a glucagon-like peptide-1 (GLP-1) receptor agonist, is currently used for the treatment of type-2 diabetes, and is believed to have beneficial effects for cardiovascular diseases. However, the vascular protective mechanisms of GLP-1 receptor agonists remain largely unexplained. In the present study, we examined the effect of exendin-4 on Ang II-induced proliferation and migration of cultured rat aortic smooth muscle cells (RASMC). The major findings of the present study are as follows: (1) Ang II caused a phenotypic switch of RASMC from contractile type to synthetic proliferative type cells; (2) Ang II caused concentration-dependent RASMC proliferation, which was significantly inhibited by the pretreatment with exendin-4; (3) Ang II caused concentration-dependent RASMC migration, which was effectively inhibited by the pretreatment with exendin-4; (4) exendin-4 inhibited Ang II-induced phosphorylation of ERK1/2 and JNK in a pre-incubation time-dependent manner; and (5) U0126 (an ERK1/2 kinase inhibitor) and SP600125 (a JNK inhibitor) also inhibited both RASMC proliferation and migration induced by Ang II stimulation. These results suggest that exendin-4 prevented Ang II-induced VSMC proliferation and migration through the inhibition of ERK1/2 and JNK phosphorylation caused by Ang II stimulation. This indicates that GLP-1 receptor agonists should be considered for use in the treatment of cardiovascular diseases in addition to their current use in the treatment of diabetes mellitus.