To study the pharmacokinetic profile after hepatic arterial embolization with superabsorbent microspheres (QuadraSpheres) loaded with doxorubicin.
Materials and Methods
Rabbits with hepatic VX2 tumors were treated with intra-arterial administration of QuadraSpheres loaded with doxorubicin, or transarterial chemoembolization (TACE) using doxorubicin, Lipiodol and Embospheres, or hepatic arterial infusion (HAI) of doxorubicin. Tumor specimens were evaluated by fluorescence microscopy, and plasma and tumor concentrations of doxorubicin were measured.
The peak plasma concentration of doxorubicin was lower in the QuadraSphere group (309.9 ng/ml) than in the HAI (673.4 ng/ml) or TACE (360.5 ng/ml) groups, suggesting higher tumor retention in the QuadraSphere group. Intratumoral doxorubicin levels declined to negligible levels at 1 and 3 days after treatment, respectively in the HAI and TACE groups. In the QuadraSphere groups, intratumoral doxorubicin level declined after day 1, but was still detectable at 14 days after treatment and was higher than that in the other groups at 1, 3, and 7 days. Intratumoral doxorubicin fluorescence was detected at all time points in the QuadraSphere group, but only at 1 day after treatment in the TACE group.
Hepatic arterial administration of doxorubicin-loaded QuadraSpheres enables the sustained release of doxorubicin to hepatic tumors.
Hepatic artery embolization; Drug-eluting microspheres; Pharmacokinetics
To compare treatment response after transarterial chemoembolization (TACE) for hepatocellular carcinoma (HCC) in patients with and without a transjugular intrahepatic portosystemic shunt (TIPS).
Materials and Methods
A retrospective review of patients who underwent conventional TACE for HCC between January 2005 and December 2009 identified 10 patients with patent TIPS. From the same time period, 23 patients without TIPS were selected to control for comparable Model for End-Stage Liver Disease and Child–Pugh–Turcotte scores. The two groups showed similar distribution of Barcelona Clinic Liver Cancer and United Network of Organ Sharing stages. Target HCC lesions were evaluated according to the modified response evaluation criteria in solid tumors (mRECIST) guidelines. Transplantation rate, time to tumor progression, and overall survival (OS) were documented.
After TACE, the rate of complete response was significantly greater in non-TIPS patients compared with TIPS patients (74 vs. 30 %, p = 0.03). Objective response rate (complete and partial response) trended greater in the non-TIPS group (83 vs. 50 %, p = 0.09). The liver transplantation rate was 80 and 74 % in the TIPS and non-TIPS groups, respectively (p = 1.0). Time to tumor progression was similar (p = 0.47) between the two groups. OS favored the non-TIPS group (p = 0.01) when censored for liver transplantation.
TACE is less effective in achieving complete or partial response using mRECIST criteria in TIPS patients compared with those without a TIPS. Nevertheless, similar clinical outcomes may be achieved, particularly in TIPS patients who are liver-transplantation candidates.
Interventional oncology; Transjugular intrahepatic portosystemic shunt; Transarterial chemoembolization; Hepatocellular carcinoma
The drop-off risk for patients awaiting liver transplantation for hepatocellular carcinoma (HCC) is 22%. Transplant liver availability is expected to worsen, resulting in longer waiting times and increased drop-off rates. Our aim was to determine whether chemoembolization can decrease this risk.
Patients and Methods
Eighty-seven consecutive HCC patients listed for liver transplant (Milan criteria) underwent statistical comparability adjustments using the propensity score (Wilcoxon, Fisher’s, and chi-square tests). Forty-three nonchemoembolization patients and 22 chemoembolization patients were comparable for Child-Pugh and Model for End-Stage Liver Disease scores, tumor size and number, alpha fetoprotein (AFP) levels, and cause of cirrhosis. We calculated the risk of dropping off the transplant list by assigning a transplant time to those who dropped off (equal probability with patients who were on the list longer than the patient in question). The significance level was obtained by calculating the simulation distribution of the difference compared with the permutations of chemoembolization versus nonchemoembolization assignment of the patients. Kaplan–Meier estimators (log-rank test) were used to determine survival rates.
Median follow-up was 187 ± 110 weeks (range 38 to 435, date of diagnosis). The chemoembolization group had an 80% drop-off risk decrease (15% nonchemoembolization versus 3% chemoembolization, p = 0.04). Although survival was better for the chemoembolization group, it did not reach statistical significance. Two-year survival for the nonchemoembolization and chemoembolization group was 57.3% ± 7.1% and 76.0% ± 7.9%, respectively (p = 0.078).
Chemoembolization appears to result in a significant decrease in the risk of dropping off liver transplant list for patients with HCC and results in a tendency toward longer survival.
Chemoembolization; Liver transplantation; HCC; Milan criteria; Drop off risk
This study was designed to evaluate the relationship between the minimal margin size and local tumor progression (LTP) following CT-guided radiofrequency ablation (RFA) of colorectal cancer liver metastases (CLM).
An institutional review board-approved, HIP-PA-compliant review identified 73 patients with 94 previously untreated CLM that underwent RFA between March 2003 and May 2010, resulting in an ablation zone completely covering the tumor 4–8 weeks after RFA dynamic CT. Comparing the pre- with the post-RFA CT, the minimal margin size was categorized to 0, 1–5, 6–10, and 11–15 mm. Follow-up included CT every 2–4 months. Kaplan–Meier methodology and Cox regression analysis were used to evaluate the effect of the minimal margin size, tumor location, size, and proximity to a vessel on LTP.
Forty-five of 94 (47.9 %) CLM progressed locally. Median LTP-free survival (LPFS) was 16 months. Two-year LPFS rates for ablated CLM with minimal margin of 0, 1–5 mm, 6–10 mm, 11–15 mm were 26, 46, 74, and 80 % (p < 0.011). Minimal margin (p = 0.002) and tumor size (p = 0.028) were independent risk factors for LTP. The risk for LTP decreased by 46 % for each 5-mm increase in minimal margin size, whereas each additional 5-mm increase in tumor size increased the risk of LTP by 22 %.
An ablation zone with a minimal margin uniformly larger than 5 mm 4–8 weeks postablation CT is associated with the best local tumor control.
Ablation; Radiofrequency ablation; Minimal margin; Local tumor progression; Colon cancer liver metastasis; Image guided; CT guided; Ablation margin evaluation method
Intermediate-stage hepatocellular carcinoma (HCC) is usually treated with locoregional therapy using transarterial chemoembolization (TACE). Transarterial radioembolization (TARE) using β-emitting yttrium-90 integral to the glass matrix of the microspheres is an alternative to TACE. This retrospective case-control study compared the outcomes and safety of TARE versus TACE in patients with unresectable HCC.
Materials and Methods
Patients with unresectable HCC without portal vein thrombosis treated with TARE between 2005 and 2008 (n = 61) were retrospectively frequency-matched by age, sex, and liver dysfunction with TACE-treated patients (n = 55) in the Mayo Clinic Hepatobiliary Neoplasia Registry. Imaging studies were reviewed, and clinical and safety outcomes were abstracted from the medical records.
Complete tumor response was more common after TARE (12 %) than after TACE (4 %) (p = 0.17). When complete response was combined with partial response and stable disease, there was no difference between TARE and TACE. Median survival did not differ between the two groups (15.0 months for TARE and 14.4 months for TACE; p = 0.47). Two-year survival rates were 30 % for TARE and 24 % for TACE. TARE patients received fewer treatments (p <0.001). Fifty-nine (97 %) TARE patients received outpatient treatment. In contrast, 53 (98 %) TACE patients were hospitalized for ≥1 day (p <0.001). Compared with TACE, TARE was more likely to induce fatigue (p = 0.003) but less likely to cause fever (p = 0.02).
There was no significant difference in efficacy between TARE and TACE. TARE patients reported more fatigue but had less fever than TACE patients. Treatment with TARE required less hospitalization than treatment with TACE. These findings require confirmation in randomized trials.
Chemoembolization; Efficacy; Hepatocellular carcinoma; Radioembolization; Safety; Yttrium-90
To determine the magnitude and spatial distribution of temperature elevations when using 480 kHz RF and 2.45 GHz microwave energy in ex vivo liver models.
Materials and Methods
A total of sixty heating cycles (20 s at 90 W) were performed in normal, RF ablated and microwave ablated liver tissues (n=10 RF and n=10 microwave in each tissue type). Heating cycles were performed using a 480 kHz generator and 3 cm cooled-tip electrode (RF) or a 2.45 GHz generator and 14-gauge monopole (microwave) and designed to isolate direct heating from each energy type. Tissue temperatures were measured using fiberoptic thermosensors 5, 10 and 15 mm radially from the ablation applicator at the depth of maximal heating. Power delivered, sensor location, heating rates and maximal temperatures were compared using mixed effects regression models.
No significant differences were noted in mean power delivered or thermosensor locations between RF and microwave heating groups (P>0.05). Microwaves produced significantly more rapid heating than RF at 5, 10 and 15mm in normal tissue (3.0 vs. 0.73, 0.85 vs. 0.21 and 0.17 vs. 0.09 °C/s; P<.05); and at 5 and 10mm in ablated tissues (2.3 ± 1.4 vs. 0.7 ± 0.3, 0.5 ± 0.3 vs. 0.2 ± 0.0 C/s, P<.05). The radial depth of heating was approximately 5mm greater for microwaves than RF.
Direct heating obtained with 2.45 GHz microwave energy using a single needle-like applicator is faster and covers a larger volume of tissue than 480 kHz RF energy. Keywords: microwave ablation, direct heating, thermal ablation
microwave ablation; direct heating; thermal ablation
To evaluate the safety and efficacy of prophylactic uterine artery embolization (UAE)-assisted cesarean section for the prevention of intrapartum hemorrhage.
Materials and Methods
Twelve consecutive pregnant women (mean age 31 years; range 25–38) with uterine scarring and placenta previa and/or placenta accreta underwent UAE in conjunction with cesarean section to prevent intrapartum hemorrhage. For UAE, the left uterine artery was catheterized prophylactically under fluoroscopic guidance before the cesarean section incision was made. After the infant had been delivered, bilateral UAE was performed with the placenta still in situ. After successful bilateral UAE, the placenta was detached from the uterine wall.
Technical success was achieved in all 12 cases. Ten patients retained their uterus, and the other 2 underwent hysterectomy. The mean operative blood loss was 1,391 mL (range 600–3,600 mL). The total mean fluoroscopy time and mean absorbed dose (air kerma) were 9 min 40 s (range 4 min 35 s–15 min 24 s) and 91.79 mGy (range 30.2–171), respectively. The average fetal fluoroscopy time was 1 min 42 s (range 41 s to 3 min 16 s) with an average X-ray dose of 17.66 mGy (range 6.04–23.90).
UAE-assisted cesarean section is safe and effective in the prevention of intrapartum hemorrhage in patients with uterine scarring and/or placental abnormalities.
Uterine artery embolization; Intrapartum hemorrhage; Abnormal placentation; Hysterectomy; Cesarean section
This study was designed to determine the tumorigenicity of the AS30D HCC cell line following orthotopic injection into rat liver and preliminarily characterize the tumor model by both magnetic resonance imaging (MRI) and ultrasound (US) as well as histopathology and immunohistochemistry.
AS30D cell line in vitro proliferation was assessed by using MTT assay. Female rats (N = 5) underwent injection of the AS30D cell line into one site in the liver. Rats subsequently underwent MR imaging at days 7 and 14 to assess tumor establishment and volume. One rat underwent US of the liver at day 7. Rats were euthanized at day 7 or 14 and livers were subjected to gross, histopathologic (H&E), and immunohistochemical (CD31) analysis to assess for tumor growth and neovascularization.
AS30D cell line demonstrated an in vitro doubling time of 33.2 ± 5.3 h. MR imaging demonstrated hyperintense T2-weighted and hypointense T1-weighted lesions with tumor induction in five of five and three of three sites at days 7 and 14, respectively. The mean (SD) tumor volume was 126.1 ± 36.2 mm3 at day 7 (N = 5). US of the liver demonstrated a well-circumscribed, hypoechoic mass and comparison of tumor dimensions agreed well with MRI. Analysis of H&E- and CD31-stained sections demonstrated moderate-high grade epithelial tumors with minimal tumor necrosis and evidence of diffuse intratumoral and peritumoral neovascularization by day 7.
AS30D HCC cell line is tumorigenic following orthotopic injection into rat liver and can be used to generate an early vascularizing, slower-growing rat HCC tumor model.
Hepatocellular carcinoma; Rat model; Magnetic resonance imaging
A new melphalan hemoperfusion filter (GEN 2) was evaluated in a simulated-use porcine model of percutaneous hepatic perfusion (PHP). The current study evaluated melphalan filtration efficiency, the transfilter pressure gradient, and the removal of specific blood products.
Materials and Methods
A porcine PHP procedure using the GEN 2 filter was performed under Good Laboratory Practice conditions to model the 60-min clinical PHP procedure.
The mean filter efficiency for removing melphalan in six filters was 99.0 ± 0.4 %. The transfilter pressure gradient across the filter averaged 20.9 mmHg for the 60-min procedure. Many blood components, including albumin and platelets, decreased on average from 3.55 to 2.02 g/dL and from 342 to 177 × 10.e3/μL, respectively, during the procedure.
The increased melphalan extraction efficiency of the new filter is expected to decrease systemic melphalan exposure. In addition, the low transfilter pressure gradient resulted in low resistance to blood flow in the GEN 2 filter, and the changes to blood components are expected to be clinically manageable.
Electronic supplementary material
The online version of this article (doi:10.1007/s00270-013-0826-5) contains supplementary material, which is available to authorized users.
Percutaneous hepatic perfusion; Cancer; Melphalan; Liver; Chemofiltration; Porcine
To retrospectively evaluate risk factors for aggravation of esophageal varices (EV) within 1 year after balloon-occluded retrograde transvenous obliteration (B-RTO) of gastric varices (GV) and to clarify suitable timing for upper endoscopy to detect EV aggravation after B-RTO.
Participants included 67 patients who underwent B-RTO for GV between January 2006 and December 2010. Whether EV aggravation occurred within 1 year was evaluated, and the time interval from B-RTO to aggravation was calculated. Factors potentially associated with EV aggravation were analyzed.
B-RTO was successfully performed in all patients. EV aggravation at 1 year after B-RTO was found in 38 patients (56.7 %). Multivariate logistic regression analysis showed that total bilirubin (T-bil) (P = 0.032) and hepatic venous pressure gradient (HVPG) (P = 0.011) were significant independent risk factors for EV aggravation after B-RTO. Cutoff values of T-bil and HVPG yielding maximal combined sensitivity and specificity for EV aggravation were 1.6 mg/dL and 13 mmHg, respectively. The patients with T-bil ≥ 1.6 mg/dL or HVPG ≥ 13 mmHg had a median aggravation time of 5.1 months. All five patients with ruptured EV belonged to this group. In contrast, patients with T-bil < 1.6 mg/dL and HVPG < 13 mmHg had a median aggravation time of 21 months.
T-bil and HVPG were significant independent risk factors for EV aggravation after B-RTO. The patients with T-bil ≥ 1.6 mg/dL or HVPG ≥ 13 mmHg require careful follow-up evaluation, including endoscopy.
Embolization; Portal vein hypertension; Transcatheter therapy; Varices; Venous intervention
This study examined the safety, pharmacokinetics, and efficacy of transarterial chemoembolization of hepatocellular carcinoma (HCC) using a newly developed size of a superabsorbent polymer drug-eluting embolic material.
Forty-five patients with documented HCC (Child–Pugh score A/B: 55.5 %/44.5 %) were embolized with HepaSphere microspheres 30–60 μm with escalation of lesion, dose, and frequency of re-embolization. Local response was evaluated with modified response evaluation criteria in solid tumors (mRECIST). Plasma levels of doxorubicin were measured in 24 patients at baseline and at 5, 20, 40, 60, and 120 min, at 6, 24, and 48 h, and at 7 days, respectively, to determine doxorubicin in plasma (Cmax) and area under the curve (AUC). Measurements of three patients who underwent lipiodol-based conventional chemoembolization (c-TACE) were also performed.
TACE with HepaSphere was well tolerated with an acceptable safety profile and no 30-day mortality. Response rates were calculated on intention-to-treat basis with complete response (CR) in 17.8 % reaching 22.2 % for the target lesion. Overall partial response (PR) was seen in 51.1 %, stable disease in 20 %, and progressive disease in 11.1 % of patients. Overall objective response (CR + PR), including patients treated at all dosages of doxorubicin, was seen in 68.9 % of cases. After a median follow-up of 15.6 months, 1-year survival is 100 %. Doxorubicin AUC was significantly lower in patients with HepaSphere 30–60 μm (35,195 ± 27,873 ng × min/ml) than in patients with conventional TACE (103,960 ± 16,652 ng × min/ml; p = 0.009). Cmax was also significantly lower with HepaSphere 30–60 μm (83.9 ± 32.1 ng/ml) compared with c-TACE (761.3 ± 58.8 ng/ml; p = 0.002).
HepaSphere 30–60 μm is an effective drug-eluting embolic material with a favourable pharmacokinetic profile.
Conventional chemoembolization (c-TACE); Hepatocellular carcinoma (HCC); HepaSphere; Drug eluting chemoembolization
The majority of episodes of spontaneous posterior epistaxis treated with embolisation are idiopathic in nature. The angiographic findings are typically normal. Specific angiographic signs are rare and may include the following: a tumour blush, telangiectasia, aneurysm, and/or extravasation. Selective internal carotid artery (ICA) angiography may show rare causes of epistaxis, such as traumatic or mycotic aneurysms, which require different treatment approaches. Complete bilateral selective external and internal carotid angiograms are essential to evaluation. The images should be analysed for detection of central retinal blush in the external carotid artery (ECA) and anastomoses between the branches of the ECA and ICA. Monocular blindness and stroke are two of the most severe complications. Embolisation aims to decrease flow to the bleeding nasal mucosa while avoiding necrosis of the nasal skin and palate mucosa. Embolisation is routinely performed with a microcatheter positioned in the internal maxillary artery distal to the origin of the meningeal arteries. A guiding catheter should be placed in the proximal portion of the ECA to avoid vasospasm. Embolisation with microparticles is halted when the peripheral branches of the sphenopalatine artery are occluded. The use of coils is not recommended because recurrent epistaxis may occur due to proximal embolization; moreover, the option of repeat distal embolisation is lost. The success rate of embolisation therapy (accounting for late recurrence of bleeding) varies between 71 and 94 %. Results from endoscopic surgery are quite comparable. When epistaxis is refractory to nasal packing or endoscopic surgery, embolisation is the treatment of choice in some centres.
Posterior epistaxis; Selective percutaneous embolisation; Endovascular intervention
We evaluated our initial experience of performing sclerotherapy for symptomatic hepatic cysts using polidocanol foam instead of a liquid sclerosant.
Three consecutively registered patients with symptomatic hepatic cysts (one with polycystic liver disease) underwent polidocanol foam sclerotherapy. A pigtail catheter was inserted into the targeted cyst following percutaneous cyst puncture under ultrasound guidance, and the cyst fluid was aspirated. To confirm the absence of communications between the cyst and surrounding hepatic vessels, 3 % polidocanol foam sclerosant was injected at a 1:4 ratio of polidocanol to air following digital subtraction cystography with carbon dioxide. C-arm computed tomography (CT) guidance also was used to monitor foam filling of the targeted cyst. The maximum dose of sclerosant injected per treatment session did not exceed 10 ml. The catheter was kept unclamped overnight for open drainage, and additional sclerotherapy sessions were performed on subsequent days, if needed.
Efficient sclerotherapy was achieved with an average of two sessions. The initial mean cyst volume was 1,052 ml, and gradual resolution was observed without recurrence. The mean reduction rate was 97.9 % (97.7–98.3 %), and all cyst-associated symptoms disappeared. The median follow-up period was 17 (range 6–21) months. Although one patient experienced moderate-grade fever and another moderate pain at the puncture site, no major complications were observed.
Polidocanol foam sclerotherapy is a safe and effective treatment for symptomatic hepatic cysts.
Hepatic cyst; Sclerotherapy; Polidocanol foam; Carbon dioxide; C-arm CT
Personalized therapies play an increasingly critical role in cancer care; Image guidance with multimodality image fusion facilitates the targeting of specific tissue for tissue characterization, and plays a role in drug discovery and optimization of tailored therapies. PET, MRI and contrast enhanced CT may offer additional information not otherwise available to the operator during minimally invasive image guided procedures such as biopsy and ablation. With use of multimodality image fusion for image-guided interventions, navigation with advanced modalities does not require the physical presence of the PET, MRI, or CT imaging system. Several commercially available methods of image fusion and device navigation are reviewed along with an explanation of common tracking hardware and software. An overview of current clinical applications for multimodality navigation is provided.
Bleeding from mesenteric varices associated with portal hypertension is occasionally life-threatening. A 53-year-old man who had undergone esophageal transection for esophageal varices and balloon-occluded retrograde transvenous obliteration for gastric varices presented with melena due to ruptured mesenteric varices. He was treated by injecting N-butyl-2-cyanoacrylate via an abdominal wall vein to obtain retrograde transvenous obliteration.
To evaluate safety in an interim analysis of transarterial chemoembolization (TACE) with doxorubicin-eluting beads (DEB) in 13 patients with hepatic metastases from neuroendocrine tumors (NETs) as part of a phase II trial.
Institutional Review Board approval and informed consent were obtained. Thirteen patients completed preliminary safety analysis. Their mean age was 65 years, Eastern Cooperative Oncology Group status was 0/1, tumor burden range was 4–75 %, and mean targeted tumor size was 5.9 cm. Up to four DEB-TACE sessions (100–300 μm beads loaded with ≤100 mg doxorubicin) within 6 months were allowed. Tumor response was assessed by magnetic resonance imaging 1 month after treatment using contrast-enhancement [European Association for the Study of the Liver (EASL) and size Response Evaluation Criteria in Solid Tumors (RECIST)] criteria. Safety was assessed by National Cancer Institute Common Terminology Criteria.
DEB-TACE was successfully performed in all 13 patients. At 1 month follow-up, there was a mean 12 % decrease in tumor size (p <0.0003) and a 56 % decrease in tumor enhancement (p <0.0001). By EASL criteria, the targeted lesion objective response rate was 78 %. Grade 3 to 4 toxicities were fatigue (23 %), increased alanine amino transferase (15 %), hyperglycemia (15 %), and abdominal pain (8 %). Seven patients developed bilomas (54 %); all of these patients had multiple small (<4 cm) lesions. Subsequently, four underwent percutaneous drainage, three for abscess formation and one for symptoms related to mass effect.
Although biloma and liver abscess are known risks after TACE, the high incidence in our study population was unexpected and forced interruption of the trial. Although this occurred in a small group of patients, we have changed our technique and patient selection as a result of these findings, thus allowing resumption of the trial.
Biliary injury; Chemoembolization; Drug-eluting beads; Neuroendocrine metastases
A 67-year-old woman resented with an acute type A aortic dissection, which was treated surgically with aortic valve replacement as a composite graft with reimplantation of the coronary arteries. At the end of surgery, a left-ventricular venting catheter was placed through the apex and closed with a buffered suture. Consecutive computed tomography (CT) examinations verified a growing apex pseudoaneurysm. Communication between the ventricle and the pseudoaneurysm was successfully closed with an Amplatz septal plug by the transfemoral route. Follow-up CT showed an additional pseudoaneurysm, which also was successfully closed using the same method.
The Zilver PTX drug-eluting stent (Cook Ireland Ltd., Limerick, Ireland) represents an advance in endovascular treatments for atherosclerotic superficial femoral artery (SFA) disease. Clinical data demonstrate improved clinical outcomes compared to bare-metal stents (BMS). This analysis assessed the likely impact on the French public health care budget of introducing reimbursement for the Zilver PTX stent.
A model was developed in Microsoft Excel to estimate the impact of a progressive transition from BMS to Zilver PTX over a 5-year horizon. The number of patients undergoing SFA stenting was estimated on the basis of hospital episode data. The analysis from the payer perspective used French reimbursement tariffs. Target lesion revascularization (TLR) after primary stent placement was the primary outcome. TLR rates were based on 2-year data from the Zilver PTX single-arm study (6 and 9 %) and BMS rates reported in the literature (average 16 and 22 %) and extrapolated to 5 years. Net budget impact was expressed as the difference in total costs (primary stenting and reinterventions) for a scenario where BMS is progressively replaced by Zilver PTX compared to a scenario of BMS only.
The model estimated a net cumulative 5-year budget reduction of €6,807,202 for a projected population of 82,316 patients (21,361 receiving Zilver PTX). Base case results were confirmed in sensitivity analyses.
Adoption of Zilver PTX could lead to important savings for the French public health care payer. Despite higher initial reimbursement for the Zilver PTX stent, fewer expected SFA reinterventions after the primary stenting procedure result in net savings.
Budget impact model; Drug-eluting stent; Paclitaxel-eluting stent; Peripheral artery disease; Superficial femoral artery
Stenting in intracranial atherosclerotic disease (ICAD) is increasingly debated, due to issues of procedural safety, technical efficacy, and in-stent recurrent stenoses (ISR). In the present study, feasibility, safety, and efficacy of angioplasty using a drug-eluting balloon (DEB) followed by the implantation of a self-expanding stent (Enterprise) were evaluated for the treatment of ICAD lesions.
Fifty-two patients (median age: 71 years; range: 54–86 years; male/female ratio 37:15) underwent stenting of high-grade ICAD lesions between February 2010 and November 2011 in a single center. Angioplasty using a paclitaxel coated SeQuent Please (B. Braun, Germany) or DIOR (Eurocor, Germany) coronary PTCA balloon, followed by the implantation of a self-expanding stent (Enterprise, Codman, USA) was performed in 54 lesions. Angiographic and clinical follow-up was performed at 6 and 12 weeks, 6 and 12 months, and yearly thereafter. Technical success rate, periprocedural complications, occurrence of recurrent ischemic symptoms, and the development of an ISR were analyzed.
Angioplasty using a DEB followed by stent implantation was successfully performed in 44 (81 %) cases. DEB insertion failed in 19 % of the cases and angioplasty was finally performed using a conventional PTCA balloon. The combined procedure related permanent neurologic morbidity and mortality rate (stroke, ICH, and subarachnoid hemorrhage) at 30 days and beyond was 5 %. Angiographic and clinical follow-up were obtained in 33 (61 %) lesions in 32 patients. Recurrent stenosis was seen in one (3 %) lesion.
Angioplasty and stenting using a DEB is safe and yields encouragingly low ISR rates. Further technical developments to improve lesion accessibility are, nevertheless, mandatory.
Neurointerventions; Arterial intervention; Angioplasty/angiogram