Molecular immuno-imaging improves tumor detection in head and neck cancer.

Detection and accurate delineation of tumor is important for the management of head and neck squamous cell carcinoma (HNSCC) but is challenging with current imaging techniques. In this study, we evaluated whether molecular immuno-imaging targeting myeloperoxidase (MPO) activity, an oxidative enzyme secreted by many myeloid innate immune cells, would be superior in detecting tumor extent compared to conventional contrast agent (DTPA-Gd) in a carcinogen-induced immunocompetent HNSCC murine model and corroborated in human surgical specimens. In C57BL/6 mice given 4-nitroquinoline-N-oxide (4-NQO), there was increased MPO activity in the head and neck region as detected by luminol bioluminescence compared to that of the control group. On magnetic resonance imaging, the mean enhancing volume detected by the MPO-targeting agent (MPO-Gd) was higher than that by the conventional agent DTPA-Gd. The tumor volume detected by MPO-Gd strongly correlated with tumor size on histology, and higher MPO-Gd signal corresponded to larger tumor size found by imaging and histology. On the contrary, the tumor volume detected by DTPA-Gd did not correlate as well with tumor size on histology. Importantly, MPO-Gd imaging detected areas not visualized with DTPA-Gd imaging that were confirmed histopathologically to represent early tumor. In human specimens, MPO was similarly associated with tumors, especially at the tumor margins. Thus, molecular immuno-imaging targeting MPO not only detects oxidative immune response in HNSCC, but can better detect and delineate tumor extent than nonselective imaging agents. Thus, our findings revealed that MPO imaging could improve tumor resection as well as be a useful imaging biomarker for tumor progression, and potentially improve clinical management of HNSCC once translated.

Safety and Efficacy of Percutaneous Lumbar Discectomy and Percutaneous Disc Cementoplasty for Painful Lumbar Disc Herniation in Patients over 60 Years.

PURPOSE: To determine the safety and efficacy of percutaneous lumbar discectomy (PLD) and percutaneous disc cementoplasty (PDCP) for painful lumbar disc herniation (LDH) in patients >60 years of age. MATERIALS AND METHODS: Sixteen older patients (mean age, 71.00 ± 6.24 years) with painful LDH were treated with PLD and PDCP. The outcome data (the Macnab criteria, visual analog scale score, and Oswestry disability index) were collected preoperatively; at 1 week postoperatively; at posttreatment months 1, 3, and 6; and every 6 months thereafter. In addition, treatment duration, injection volume of bone cement, length of hospital stay, and complications were assessed. RESULTS: Treatment was successful in all patients. The pain relief rate at the last follow-up was 87.5%. Six, 8, and 2 patients showed excellent, good, and fair results, respectively; no patient showed a poor result. The average visual analog scale for back and leg pain decreased from 6.75 ± 1.06 and 7.00 ± 0.89 before the procedure to 2.81 ± 1.60 and 2.87 ± 1.75 at 1 month, 2.79 ± 1.58 and 2.71 ± 1.64 at 6 months, and 2.90 ± 1.73 and 3.00 ± 1.76 at 1 year, respectively. The scores were 2.44 ± 1.63 and 2.44 ± 1.71, respectively, at the last follow-up. The Oswestry disability index also changed after the procedure, with significant differences between baseline scores and those at each follow-up (P < .001). The mean procedure duration, injection volume of bone cement, and length of hospital stay were 55.69 ± 5.86 minutes, 2.50 ± 0.63 mL, and 7.06 ± 2.41 days, respectively. There were no complications. CONCLUSIONS: The combination of PLD and PDCP is feasible, safe, and effective for older patients with painful LDH.

Technical feasibility and tissue reaction after silicone-covered biodegradable magnesium stent insertion in the oesophagus: a primary study in vitro and in vivo.

OBJECTIVES: Determine the feasibility of and tissue response to biodegradable magnesium-silicone stent insertion into the oesophagus of rabbits. METHODS: Mechanical compression-recovery and degradation behaviours of the stents were investigated in vitro. Thirty rabbits were randomly divided into a magnesium-silicone stent group (n = 15) that received stent insertion into the lower 1/3 of the oesophagus under fluoroscopic guidance and a control group (n = 15). Oesophagography was performed at 1, 2 and 4 weeks. Five rabbits in each group were euthanized at each time point for histological examination. RESULTS: Magnesium-silicone stents showed good flexibility and elasticity, and degraded more slowly than bare stents at pH 4.0 and 7.4. All stent insertions were well tolerated. The oesophageal diameters at 1, 2 and 4 weeks were 9.7 ± 0.7, 9.6 ± 0.8 and 9.6 ± 0.5 mm, respectively (vs. 9.2 ± 0.8 mm before intervention; P > 0.05). Stent migration occurred in six rabbits (one at 1 week, one at 2 and four at 4). Microscopy demonstrated dilation of the oesophageal wall within 1 week of insertion. Oesophageal injury and collagen deposition following stent insertion were similar to control (P > 0.05). CONCLUSIONS: Oesophageal magnesium-silicone stent insertion was feasible and provided reliable support for 2 weeks without causing oesophageal injury or collagen deposition. KEY POINTS: • Mg stent provided apparently adequate radial force and silicone membrane reduced magnesium biodegradation • Stent insertion provided good support for at least 2 weeks before biodegradation • Stenting effectively resulted in oesophageal wall remodelling, without demonstrable injury.

String-like lumen in below-the-knee chronic total occlusions on contrast-enhanced magnetic resonance angiography predicts intraluminal recanalization and better blood flow restoration.

OBJECTIVES: To determine whether string-like lumina (SLs) on contrast-enhanced magnetic resonance angiography (CE-MRA) predict better outcomes in diabetic patients with below-the-knee (BTK) chronic total occlusions (CTOs). METHODS: This study involved 317 long-segment (>5 cm) BTK CTOs of 245 patients that were examined using CE-MRA and treated using endovascular angioplasty. An SL with a CTO was slowly filled with blood on conventional CE-MRA. Univariate and multivariate analyses were performed to identify predictors of procedural success, recanalisation method and immediate blood flow restoration. The target-lesion patency and limb-salvage rates were assessed. RESULTS: SL-positive CTOs (n = 60) achieved a higher technique success rate, preferred intraluminal angioplasty and better blood flow restoration than SL-negative CTOs (n = 257, P < 0.05). Multivariate analyses revealed that lesion length was the independent predictor of procedural success (P = 0.028). SL was a predictor of intraluminal angioplasty (P < 0.001) and good blood-flow restoration (P = 0.004). Kaplan-Meier analyses at 12 months revealed a higher target lesion patency rate (P = 0.04) and limb-salvage rate (P = 0.35) in SL-positive CTOs. CONCLUSIONS: In patients with BTK CTOs, SL predicted intraluminal angioplasty and good blood-flow restoration for BTK CTOs. KEY POINTS: • Intraluminal recanalisation was more frequently used for BTK-CTOs with SLs than without • CTO length was the only independent predictor of successful CTO recanalisation • SL was the only predictor of intraluminal angioplasty for BTK-CTOs • SL and CTO length were predictors of good blood-flow restoration after recanalisation • Restenosis-free and limb-salvage rates were better for SL-positive CTOs than SL-negative CTOs.

Percutaneous Vertebroplasty for Palliative Treatment of Painful Osteoblastic Spinal Metastases: A Single-Center Experience.

PURPOSE: To evaluate safety and efficacy of fluoroscopy-guided percutaneous vertebroplasty (PVP) for painful osteoblastic spinal metastases. MATERIALS AND METHODS: PVP was performed in 39 consecutive patients (median age, 60.1 y ± 9.5) with 51 osteoblastic metastatic spinal lesions; 14 patients had pathologic fractures. The patients were followed for 3-30 months (average, 14.5 mo ± 7.4). Visual analog scale (VAS), Oswestry Disability Index (ODI), and Karnofsky performance scale (KPS) were used to evaluate pain, quality of life, and performance status before the procedure and at 3 days and 1, 3, 6, 12, and 18 months after the procedure. RESULTS: Technical success was achieved in all patients. Minimal follow-up time was 3 months. Mean VAS scores declined significantly from 7.4 ± 1.1 before the procedure to 2.5 ± 0.9 by day 3 after the procedure and were 2.1 ± 1.1 at 1 month, 2.0 ± 1.1 at 3 months, 1.9 ± 1.1 at 6 months, 1.8 ± 0.9 at 12 months, and 1.7 ± 0.7 at 18 months after the procedure (P < .001). ODI and KPS scores also changed after the procedure, with significant differences between baseline scores and at each follow-up examination (P < .001). Extraosseous cement leakage occurred in 15 cases without causing any clinical complications. CONCLUSIONS: PVP is a safe and effective treatment for painful osteoblastic spinal metastases. It can relieve pain, reduce disability, and improve function.

Runoff detected by magnetic resonance angiography as an indicator for better recanalization outcomes in below-the-knee chronic total occlusions in diabetic patients.

PURPOSE: To compare the feasibility and efficacy of recanalizing below-the-knee (BTK) chronic total occlusions (CTOs) between patients with good or poor distal runoff based on magnetic resonance angiography (MRA) scans. METHODS: Two hundred long-segment BTK CTOs in 171 limbs of 113 diabetic patients (58 men; mean age 69.8±1.9 years) were divided into good distal runoff (GDR: 119 lesions, 98 limbs) or poor distal runoff groups (PDR: 81 lesions, 73 limbs) based on baseline MRA findings. After angioplasty, modified thrombolysis in myocardial ischemia (mTIMI) grades and ankle-brachial index (ABI) were used to assess immediate outcomes. Regularly scheduled duplex or MRA imaging was performed in follow-up. The restenosis and limb salvage rates were compared. RESULTS: The success rates were 93.3% and 87.7% in the GDR and PDR groups, respectively (p=0.21); subintimal angioplasty was more common in the PDR group (93.0% vs. 63.1%, p<0.01). Completion angiography indicated an mTIMI grade 3 blood flow in 71.2% lesions in the GDR patients and in 52.1% in the PDR (p=0.01) group. Improvement in the ABI was greater in the GDR limbs (p<0.001 vs. PDR). Mean imaging follow-up was 10.8±6.9 months in the GDR group and 11.1±6.6 months in the PDR group. Kaplan-Meier analysis showed a better restenosis-free rate in the GDR group (80.6% vs. 61.7%; p=0.02) at 12 months and for lesions with mTIMI grade 3 flow (p<0.01). At 24 months, Kaplan-Meier analysis revealed a better limb salvage rate in the GDR group (84.2% vs. 54.6%; p=0.02). CONCLUSION: Distal runoff detected using MRA could be a predictor for successful intraluminal recanalization, better distal tissue perfusion, improved long-term patency, and better limb salvage for patients with BTK CTOs.

Percutaneous radiologic gastrostomy via nasopharyngeal intubation for the treatment of patients with complete malignant pharyngoesophageal obstruction.

BACKGROUND/AIMS: For patients with complete malignant pharyngoesophageal obstruction (CMPO), percutaneous radiologic gastrostomy (PRG) under ultrasound/CT guidance can complicate it to cause failure due to unsatisfied stomach filling. In this study, we retrospectively investigated whether PRG via nasopharyngeal intubation is feasible and effective for these patients. METHODOLOGY: PRG via nasopharyngeal intubation was attempted in 21 patients with CMPO (mean 70.8 ± 8.23 years). The technique comprised a dilation of the stomach via nasopharyngeal intubation using a catheter, followed by fluoroscopically guided puncture and gastrostomy tube placement. Complications including hemorrhage, peritonitis, gastrojejunocolic fistula, infection of puncture site, tube blocking and outleakage was observed during and after the procedure. RESULTS: A 5F catheter was successfully inserted to the stomach under fluoroscopical guidance and subsequent PRG was performed in all 21 patients. Minor complications occurred in 14.3% patients including mild infection of the fistula in 1, tube blocking in 1 and unexpected tube drawing out in 1. Follow-up nutrition indexes revealed obvious improved nutrition compared to before PRG (P < 0.05). CONCLUSION: PRG via nasopharyngeal intubation was simple, feasible and effective for patients with CMPO.

Accurate diagnosis of small cerebral aneurysms ≤5 mm in diameter with 3.0-T MR angiography.

PURPOSE: To evaluate the diagnostic accuracy of three-dimensional (3D) time-of-flight (TOF) magnetic resonance (MR) angiography at 3.0 T in the detection of small cerebral aneurysms. MATERIALS AND METHODS: The institutional review board approved the study protocol, and patients or qualifying family members provided informed consent. A total of 403 consecutive patients undergoing 3D TOF MR angiography and digital subtraction angiography (DSA) were prospectively enrolled. Small aneurysms were those 5 mm in diameter or smaller. DSA served as the reference standard. Three observers were blinded to clinical and DSA results, and they independently analyzed all 3D TOF MR angiographic data sets. Interobserver agreement was expressed in terms of Cohen κ value for categorical variables. Accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of 3D TOF MR angiography in the detection of cerebral aneurysms were determined by using patient-, aneurysm-, and location-based evaluations. RESULTS: Of 403 patients, 273 aneurysms were detected with DSA in 230 patients. Patient-based evaluation with 3D TOF MR angiography at 3.0 T yielded an accuracy of 96%-97%, a sensitivity of 98.2%-98.7%, a specificity of 93.2% -94.8%, a PPV of 94.9%-96.2%, and an NPV of 97.6%-98.2% in the detection of cerebral aneurysms. Aneurysm-based evaluation yielded an accuracy of 96.4%-97.3%, a sensitivity of 98.5%-98.9%, a specificity of 93.2%-94.9%, a PPV of 95.7%-96.8%, and an NPV of 97.6%-98.2%. Aneurysm-location evaluations yielded similar results. CONCLUSION: Three-dimensional TOF MR angiography is a noninvasive method that shows promising diagnostic accuracy in the detection of small cerebral aneurysms.

Patency of runoff detected by MR angiography at 3.0 T with cuff-compression: a predictor of successful endovascular recanalization below the knee.

OBJECTIVES: Our aim was to assess the reliability of detecting distal runoff vessels using contrast-enhanced MR angiography (CE-MRA) that were occult on digital subtraction angiography (DSA) for predicting the outcome of endovascular recanalization (ER). METHODS: This retrospective analysis comprised 63 patients with diabetes (98 limbs) who underwent ER for infrapopliteal lesions. Before ER, they underwent CE-MRA and DSA for peripheral arterial disease; runoff vessels were detected with CE-MRA, but not with DSA. Immediate and follow-up postoperative outcomes were assessed. Univariate analysis was performed to identify variables associated with successful ER. RESULTS: Successful ER was achieved in 85.7 % of limbs, and runoff score was significantly lower than in failure limbs (5.1 ± 1.1 vs. 6.2 ± 1.3; P < 0.05). During follow-up, sustained ankle-brachial index (ABI) improvement was found in 76.6 % claudication patients, and walking distance improvement in 86.5 %; pain was relieved in 70.6 % of critical limb ischemia (CLI) limbs, ulceration healed in 81.3 %, and limb-salvage rate was 100 %. Restenosis/occlusion rate was higher for patients with CLI at 12 months (48.8 % vs. 96.3 % in claudication; P < 0.01). Runoff score was associated with a significantly higher likelihood of ER success (odds ratio = 4.096, 95 % confidence interval: 2.056-8.158; P < 0.001). CONCLUSION: Runoff vessels detected using CE-MRA could indicate immediate success and better outcome of ER for infrapopliteal occlusions. KEY POINTS: • 3-T MRA with cuff compression displayed distal below-the-knee (BTK) runoffs better than DSA • Detected runoffs indicate high recanalization rate and good clinical outcome • Runoff display provides potential opportunity to perform other backup recanalization strategies.

Prevalence of unruptured cerebral aneurysms in Chinese adults aged 35 to 75 years: a cross-sectional study.

BACKGROUND: The reported prevalence of unruptured cerebral aneurysms (UCAs) varies widely. OBJECTIVE: To measure the prevalence of UCAs by using 3-dimensional time-of-flight magnetic resonance angiography in adults aged 35 to 75 years. DESIGN: Cross-sectional study done between June 2007 and June 2011. SETTING: Two communities chosen at random from 2 districts (1 urban and 1 suburban) in Shanghai, China. PARTICIPANTS: 4813 adults aged 35 to 75 years. MEASUREMENTS: Three-dimensional time-of-flight magnetic resonance angiography, interpreted by 3 observers blinded to the participants' information, was used to identify the location and size of UCAs and to estimate the overall, age-specific, and sex-specific prevalence. RESULTS: 369 UCAs were found in 336 participants (130 men and 206 women); 4477 participants had no evidence of UCAs. The prevalence was 7.0% overall (95% CI, 6.3% to 7.7%), with 5.5% for men (CI, 4.6% to 6.4%) and 8.4% for women (CI, 7.3% to 9.5%). The overall prevalence of UCAs was higher in women than in men (P < 0.001) and peaked at ages 55 to 64 years in men and women. The UCAs were mostly located in the internal carotid artery (81%), and 90.2% had a maximum diameter less than 5 mm. Mean diameter was larger in women than in men (3.7 mm vs. 3.2 mm; P < 0.009). LIMITATION: Participants were from 2 communities selected from 2 districts in Shanghai, and adults older than 75 years were not studied. CONCLUSION: The overall prevalence of UCAs was 7.0% in Chinese adults aged 35 to 75 years, and most lesions had a diameter less than 5 mm. PRIMARY FUNDING SOURCE: National Natural Science Foundation of China.

Endovascular treatment of symptomatic severe intracranial atherosclerotic stenosis with a novel intracranial dedicated drug-eluting stent: a more effective treatment approach.

Background: Endovascular treatment of severe intracranial atherosclerotic stenosis (ICAS) using coronary drug-eluting stents (DESs) significantly reduces the risk of in-stent restenosis (ISR) and stroke recurrence. However, there are few reports regarding the treatment of ICAS with intracranial dedicated DES. Herein, we present our experience with the feasibility, safety, and medium-term follow-up outcomes of a novel intracranial DES, named NOVA stent, in patients with symptomatic severe ICAS (≥70%). Methods: From December 2021 to May 2022, patients with symptomatic severe ICAS who underwent implantation of the NOVA stent in our institution were retrospectively analyzed for procedural results, perioperative complications, imaging and clinical follow-up outcomes. Results: Twenty-four patients, 16 (66.7%) with anterior circulation lesions and 8 (33.3%) with posterior circulation lesions, were enrolled. All patients with intracranial ICA (n = 6), middle cerebral artery (n = 10), basilar artery (n = 3), intracranial vertebral artery (n = 3), and the vertebrobasilar junction (n = 2) stenosis were treated successfully using NOVA stents. The severity of stenosis ranged from 75 to 96% (mean 85.9%) before treatment and this was reduced to 0 to 20% (mean 8.6%) immediately after stent placement. Symptomatic distal embolism occurred in one case; however, there were no other perioperative complications. The mean follow-up duration was 12.2 ± 1.06 months. No symptomatic ischemic events occurred during follow-up. Follow-up cerebral angiography was performed in 22 of 24 patients (91.7%), and significant ISR occurred in one patient (4.2%). Conclusion: Our results demonstrate that implantation of the novel intracranial DES NOVA in severe ICAS is feasible, safe, and effective in selected cases, reducing the incidence of ISR, and showing excellent midterm clinical outcomes, providing a promising option for ICAS treatment.

Geometric, hemodynamic, and pathological study of a distal internal carotid artery aneurysm model in dogs.

BACKGROUND AND PURPOSE: We created a distal internal carotid artery side-wall aneurysm model in dogs and compared its geometric, hemodynamic, and histological similarities with human models. METHODS: Eight distal internal carotid artery-shaped devices were constructed using rapid prototyping, and 8 aneurysms were created via surgical reconstruction and elastase incubation. The geometric and hemodynamic parameters of the aneurysm and the parent artery of the dog and human models were compared, and histological response was evaluated at 12 weeks. RESULTS: Eight aneurysms were successfully created with good geometric simulation of the arteries between the dog and human models. Hemodynamic analysis revealed similar changes in the hemodynamic parameters both in the aneurysm sac and in the parent artery of the dog and human models. Histological analysis revealed internal elastic lamina discontinuity, elastic fiber disruption, a thinner muscular layer, increased smooth muscle cell proliferation rate, increased inflammation cell infiltration, and higher matrix metalloproteinase-2 and matrix metalloproteinase-9 expression indices in the medial aneurysm wall. CONCLUSIONS: The distal internal carotid artery aneurysm model in dogs is feasible and exhibited considerable geometric, hemodynamic, and histological similarities with the original human models.

New method for retrospective study of hemodynamic changes before and after aneurysm formation in patients with ruptured or unruptured aneurysms.

BACKGROUND: Prospective observation of hemodynamic changes before and after formation of brain aneurysms is often difficult. We used a vessel surface repair method to carry out a retrospective hemodynamic study before and after aneurysm formation in a ruptured aneurysm of the posterior communicating artery (RPcomAA) and an unruptured aneurysm of the posterior communicating artery (URPcomAA). METHODS: Arterial geometries obtained from three-dimensional digital subtraction angiography of cerebral angiograms were used for flow simulation by employing finite-volume modeling. Hemodynamic parameters such as wall shear stress (WSS), blood-flow velocity, streamlines, pressure, and wall shear stress gradient (WSSG) in the aneurysm sac and at the site of aneurysm formation were analyzed in each model. RESULTS: At "aneurysm" status, hemodynamic analyses at the neck, body, and dome of the aneurysm revealed the distal aneurysm neck to be subjected to the highest WSS and blood-flow velocity, whereas the aneurysm dome presented the lowest WSS and blood-flow velocity in both model types. More apparent changes in WSSG at the aneurysm dome with an inflow jet and narrowed impaction zone were revealed only in the RPcomAA. At "pre-aneurysm" status, hemodynamic analyses in both models showed that the region of aneurysm formation was subjected to extremely elevated WSS, WSSG, and blood-flow velocity. CONCLUSIONS: These data suggest that hemodynamic analyses in patients with ruptured or unruptured aneurysms using the vessel surface repair method are feasible, economical, and simple. Our preliminary results indicated that the arterial wall was subjected to elevated WSS, WSSG and blood-flow velocity before aneurysm generation. However, more complicated flow patterns (often with an inflow jet or narrowed impaction zone) were more likely to be observed in ruptured aneurysm.

Application of the newly developed stents in the treatment of benign cardia stricture: an experimental comparative study.

BACKGROUND: Retrievable temporary stent placement has recently been suggested as a potential treatment for benign esophageal stricture. OBJECTIVE: To assess the efficacy of a newly designed cardia stent for the treatment of benign cardia stricture in a canine model compared with groups that received pneumatic dilation or standard esophageal stent insertion. DESIGN: Basic experimental study. SETTING: GI interventional center. PATIENTS: Forty-eight dog models were randomly divided into a control group (no stent insertion) (n=12), a pneumatic dilation group (PDG) (n=12), a standard esophageal stent group (SESG) (n=12), and a novel cardia stent group (NCSG) (n=12). INTERVENTIONS: Pneumatic dilation, standard esophagus stent, cardia stent. MAIN OUTCOME MEASUREMENTS: Lower esophageal sphincter pressures and the 5-minute barium height were assessed before and immediately after the procedure, after 1 week, and at 1-, 3-, and 6-month follow-up. Three dogs in each group were killed for histological examination. RESULTS: Stent insertion was tolerated by all dogs, with a lower migration rate in the NCSG (0% vs 41.7% in the SESG; P=.0373). At the 6-month follow-up, the lower esophageal sphincter pressure and 5-minute barium height values in the NCSG were still stable compared with those in the PDG and SESG (P<.05). Immunohistochemistry for mouse anti-proliferating cell nuclear antigen and α-smooth muscle actin revealed a stronger inflammatory reaction peak in the PDG than in the SESG and NCSG (P<.05). Collagen proliferation was most severe after 6 months in the PDG (P<.05). LIMITATIONS: Longer follow-up studies are required to assess whether the recurrence rate is lower because of less inflammation and scarring. CONCLUSIONS: The novel cardia stent was more effective than pneumatic dilation or a standard stent in this canine model.

Batroxobin plus aspirin reduces restenosis after angioplasty for arterial occlusive disease in diabetic patients with lower-limb ischemia.

PURPOSE: Aspirin is routinely given to reduce vascular events after angioplasty. Batroxobin has been shown to effectively prevent thrombosis after angioplasty via inhibition of the fibrinogen concentration. In this randomized clinical trial, the hypothesis that batroxobin plus aspirin is more effective than aspirin alone in reducing the incidence of restenosis/reocclusion in patients with diabetes undergoing angioplasty for lower-limb ischemia. MATERIALS AND METHODS: Patients with diabetes and symptomatic arterial obstructions (N = 129) were randomized to receive aspirin 100 mg/d plus batroxobin 5 IU every other day for six doses (n = 58) or aspirin alone (n = 71). The primary outcome was restenosis documented by magnetic resonance (MR) angiography or duplex imaging at 12 months. Secondary outcomes included amputation above the ankle, death, and cumulative rate of amputation or death. Kaplan-Meier analysis was used to evaluate limb salvage and survival rates. RESULTS: After 12 months, restenosis had occurred in 43.1% and 29.7% of patients in the control and batroxobin groups, respectively (P = .0018). MR angiography and duplex imaging revealed an improved restenosis rate for infrapopliteal lesions and for lesions longer than 10 cm (P = .0016). The primary and cumulative secondary outcomes indicated significant improvements in restenosis rate, symptom relief, and amputation rates in the batroxobin group compared with the aspirin-only group. Kaplan-Meier analysis showed limb salvage and survival rates of 78.3% in the aspirin-only group and 92.2% in the batroxobin group 12 months after angioplasty (log-rank test, P = .0414). CONCLUSIONS: Batroxobin plus aspirin reduced the rate of restenosis after arterial angioplasty, particularly in lesions located below the knee and in those longer than 10 cm, with better clinical symptom relief and improved rate of limb salvage.

Treatment of carotid siphon aneurysms by use of the Willis stent graft: an angiographic and histopathological study.

OBJECTIVE: We designed a carotid siphon (CS) aneurysm model in dogs to test a new stent graft (the Willis covered stent) and compared tissue reaction over 12-month follow-up versus a comparison group with stents implanted in straight vessels. METHODS: Twenty-four saccular sidewall aneurysms (group A) and 12 CS aneurysms (group B) were created surgically. A Willis stent graft was implanted in each aneurysm. Angiography was performed immediately and at 1-, 3-, 6- and 12-month post-implantation to investigate aneurysm isolation, endoleak, stent angulation, parent artery (PA) patency and restenosis. Light and scanning electron microscopy were used to identify aneurysmal sac thrombi, intima hyperplasia and endothelial progress. RESULTS: Immediate angiography demonstrated mild endoleak in two aneurysms and three stent angulations in group B. Follow-up at 12 months revealed resolved endoleaks, occlusion in one PA and mild stenosis in three in group B. In group A, occlusion occurred in one PA and mild stenosis in two. Light microscopy revealed new intima, and all aneurysm sacs were filled with thrombi. In group B, endothelial progress was complete at 12 months, and closely correlated with haemodynamic changes. CONCLUSIONS: Application of a Willis stent graft is a feasible method of treating CS aneurysms, and it exhibits a prolonged endothelial progress compared with that in straight vessels.

Retrograde transdorsal-to-plantar or transplantar-to-dorsal intraluminal re-entry following unsuccessful subintimal angioplasty for below-the-ankle arterial occlusion.

PURPOSE: To assess the technical feasibility and efficacy of transdorsal-to-plantar (TDP) or transplantar-to-dorsal (TPD) intraluminal re-entry following unsuccessful subintimal angioplasty for arterial occlusion below the ankle. METHODS: TDP or TPD retrograde intraluminal re-entry angioplasty was attempted in 8 limbs of 8 diabetic patients (5 men; mean age 74.5 ± 7.76 years, range 62-81) with chronic below-the-ankle arterial occlusive disease when standard transtibial subintimal angioplasty failed. The clinical symptoms, dorsal or plantar arterial pulse volume scores, and ankle-brachial indexes (ABI) were compared before and after the procedures. At follow-up, pain relief, wound healing, limb salvage, and the presence of any restenosis of the target vessels were evaluated. RESULTS: TDP or TPD retrograde intraluminal re-entry angioplasty was performed successfully in 5 (62.5%) patients; foot pain improved, with median pulse volume scores and ankle-brachial indexes increasing from 0.60 ± 0.55 and 0.32 ± 0.20 before to 2.40 ± 0.55 and 0.75 ± 0.12, respectively, after the procedure (p<0.01 for both). At the end of follow-up, the visual analogue scale improved from 7.40 ± 1.14 to 2.20 ± 1.48 (p=0.002). Ulcers in 2 of the successfully treated patients either healed (n=1) or improved (n=1). No amputation occurred. Restenosis of 1 target vessel was revealed by magnetic resonance angiography. CONCLUSION: TDP and TPD retrograde intraluminal re-entry techniques are feasible and effective in the treatment of foot ischemia in diabetic patients when standard below-the-ankle angioplasty has failed.

Application of the Willis covered stent in the treatment of aneurysm in the cisternal segment of the internal carotid artery: a pilot comparative study with midterm follow-up.

PURPOSE: To compare the use of the Willis stent-graft versus coil embolization for complicated aneurysms in the cisternal segment of the internal carotid artery (ICA). METHODS: Thirty-four patients (19 women; mean age 46.7+/-16.8 years, range 3-79) with 36 complicated aneurysms were treated either by Willis covered stents (n = 19) or by coil embolization (n = 17). Follow-up angiography was performed to investigate aneurysm recurrence, endoleak, and parent artery stenosis. Kaplan-Meier curves were constructed to compare the freedom from recurrence and parent artery stenosis rates in both groups. Clinical follow-up data were retrospectively analyzed and categorized as fully recovered, improved, unchanged, or worsened. RESULTS: In the covered stent group, total exclusion was immediately achieved in 13 aneurysms; there were 5 minor endoleaks and 1 delivery failure. In the patients treated with coil embolization, total/near-total occlusion was achieved in 7 aneurysms, subtotal in 8, and partial in 2. Acute thrombosis occurred in 1 patient in each group, while 1 patient experienced recurrent hemorrhage after embolotherapy. Follow-up angiography (mean 14.3+/-9.4, range 3-31) revealed that 16 aneurysms were completely isolated in the stent-graft group, with only 2 mild in-stent stenoses. Eighteen months after the procedure, Kaplan-Meier analysis showed recurrence-free rates of 93.3% and 50% for the stent-graft versus coil groups, respectively; freedom from parent artery stenosis was 87.5% and 100%. Symptoms were fully eliminated in 9 patients in each group; they were improved in 3 and 5, unchanged in 2 and 2, and worsened in 1 and 0, respectively, at the end of the follow-up period. CONCLUSION: Willis stent-graft application is an alternative to treat complicated aneurysms in the cisternal segment of the ICA. In the case of a tortuous parent artery or potential side branch coverage, however, it is still not a first choice therapy.

13-year follow-up of a prospective comparison of the long-term clinical efficacy of temporary self-expanding metallic stents and pneumatic dilatation for the treatment of achalasia in 120 patients.

OBJECTIVE: The purpose of this article is to compare the efficacy of self-expanding metallic stents and pneumatic dilation for the long-term clinical treatment of achalasia. SUBJECTS AND METHODS: Patients diagnosed with achalasia (n = 120) were allocated for treatment with pneumatic dilation (n = 30; group A) or a temporary self-expanding metallic stent with a diameter of 20 mm (n = 30; group B), 25 mm (n = 30; group C), or 30 mm (n = 30; group D). Data on clinical symptoms, complications, and long-term clinical outcomes were collected, and follow-up was performed at 6 months and at 1, 3-5, 5-8, 8-10, and more than 10 years after surgery. RESULTS: Pneumatic dilation and stent placement were technically successful in all patients. The follow-up at more than 10 years revealed that the clinical remission rate in group D (83.3%) was higher than that in groups A (0%), B (0%), and C (28.6%), and the overall cumulative clinical failure rate in group D (13%) was lower than that in groups A (76.7%), B (53.3%), and C (26.7%). Patients in group D exhibited reduced dysphagia scores and lower esophageal sphincter pressures and had normal levels of barium height and width during the follow-up periods, whereas these markers increased with time in the other groups. The duration of primary patency in group D was also longer than that in groups A, B, and C. CONCLUSION: A temporary self-expanding metallic stent with a diameter of 30 mm has superior clinical efficacy for the treatment of achalasia compared with pneumatic dilation or self-expanding metallic stents with diameters of 20 or 25 mm.

Comparison of temporary stent insertion with pneumatic dilation of the same diameter in the treatment of achalasia patients: a retrospective study.

BACKGROUND AND AIM: To retrospectively analyze and compare the clinical efficacy of temporary stent insertion with pneumatic dilation of the same diameter in the treatment of achalasia based on a long-term follow up. METHODS: A total of 101 treated achalasia patients were divided into a pneumatic dilation group (Group A, n = 38) and a temporary stent insertion group (Group B, n = 63). The diameter of the balloon or stent used was 30 mm. The total symptom scores (TSS) and esophageal manometry were used to assess the symptoms and lower esophageal sphincter (LES) pressure improvement. Barium swallow-esophageal studies were used to assess esophageal emptying objectively. TSS and LES pressure improvement were assessed, recorded, and compared during the regular interval follow up. RESULTS: Forty-nine pneumatic dilations and 65 stent insertions were successfully performed in all patients under fluoroscopy. Complications included pain, reflux, and bleeding, which occurred in nine (23.6%), eight (21.1%), and three (8%) patients in Group A, and in 27 (42.9%), eight (12.7%), and 10 (15.9%) patients in Group B, respectively. The stent was retained approximately 4-7 days and was retrieved via endoscope. TSS, esophageal manometry, and barium esophagram post-treatment significantly improved compared to those given pretreatment (P < 0.0001). At the end of follow up, TSS and LES pressure in Group B were 4.00 +/- 1.00 and 43.67 +/- 12.66 mmHg, compared to 10.20 +/- 0.45 (P = 0.0096) and 58.60 +/- 8.65 mmHg (P = 0.1687) in Group A. The Kaplan-Meier method revealed better symptom remission in Group B compared to Group A (log-rank test, P = 0.0212). CONCLUSION: Retrievable stent placement is more effective than the same diameter pneumatic dilation for the treatment of achalasia with a long-term follow up.