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1.
J Vasc Interv Radiol ; 33(1): 50-59, 2022 01.
Article in English | MEDLINE | ID: mdl-34628039

ABSTRACT

PURPOSE: This study aimed to demonstrate the efficacy and safety of the SoundBite Crossing System‒Peripheral (SCS-P) to facilitate crossing chronic total occlusions (CTOs) of infrainguinal arteries. MATERIALS AND METHODS: This clinical trial was approved by the Ethics Committees of all 4 participating centers and enrolled 52 patients with symptomatic de novo infrainguinal CTOs. Technical device success, the primary efficacy endpoint, was defined as the ability to facilitate the treatment of the target lesion by crossing a portion or the whole length of the CTO. Freedom from SCS-P-related major adverse events (MAEs) at 30 days after the procedure was the primary safety endpoint. RESULTS: The SCS-P met the primary efficacy and safety endpoints in 92.3% (48/52) and 100% (52/52) of subjects, respectively. Technical device success with postprocedural patency and freedom from SCS-P-related MAEs was achieved in 88.5% (46/52) of subjects. The mean CTO crossing time was 20.0 minutes ± 30.8, and the SCS-P was able to traverse the whole CTO and enter the distal true lumen without the need of any other device in 59.6% (31/52) of subjects. The mean Rutherford category and ankle-brachial index improvement at the 30-day follow-up was 2.4 ± 1.17 and 0.23 ± 0.22, respectively. CONCLUSIONS: The SCS-P demonstrated a satisfactory safety and performance profile to cross peripheral CTOs and enter the distal true lumen of infrainguinal CTOs.


Subject(s)
Peripheral Arterial Disease , Ankle Brachial Index , Chronic Disease , Femoral Artery , Humans , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/therapy , Prospective Studies , Treatment Outcome
2.
Cardiovasc Intervent Radiol ; 44(3): 368-375, 2021 Mar.
Article in English | MEDLINE | ID: mdl-33225377

ABSTRACT

PURPOSE: To report additional endpoints, including 2-year primary patency, patient outcomes, and safety results, as well as the initial assessment of hypoechogenic halo from the IMPERIAL Randomized Controlled Trial (RCT). MATERIALS AND METHODS: IMPERIAL RCT is a prospective, randomized (2:1), multicenter study of patients with symptomatic femoropopliteal artery lesions (length 30-140 mm, Rutherford category 2-4) treated with the Eluvia paclitaxel-eluting nitinol stent or the Zilver PTX paclitaxel-coated stent. Two-year follow-up included patency, safety, and mortality assessments and core laboratory-reviewed B-mode ultrasound imaging to screen for hypoechogenic halo in the stented segment, and assess blood flow. RESULTS: At 24 months, all-cause mortality was 7.1% (21/295) for Eluvia and 8.3% (12/145) for Zilver PTX (P = 0.6649). The clinically driven target lesion revascularization rate was significantly less for patients treated with Eluvia vs Zilver PTX (12.7% vs 20.1%; P = 0.0495). The Kaplan-Meier estimate of primary patency at 24 months was 83.0% for Eluvia and 77.1% for Zilver PTX (log rank P = 0.1008). Transverse ultrasound imaging was implemented during the 24-month follow-up window and was evaluable for 27.5% (128/465) of patients. Hypoechogenic halo prevalence rates did not differ significantly between Eluvia and Zilver PTX study arms (33.7% [29/86] vs 21.4% [9/42]; P = 0.153). In no case was flow documented within the halo; no adverse events were associated with these ultrasound findings. CONCLUSION: Two-year follow-up suggests a sustained advantage for Eluvia for avoiding target lesion revascularization. Initial hypoechogenic halo assessment showed no difference in prevalence between the study arms, no flow within the halo, and no associated adverse events. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov identifier NCT02574481. Date of registration: October 14, 2015. LEVEL OF EVIDENCE: Level 1; randomized controlled trial.


Subject(s)
Drug-Eluting Stents , Endovascular Procedures/methods , Femoral Artery/surgery , Paclitaxel/administration & dosage , Peripheral Arterial Disease/therapy , Popliteal Artery/surgery , Aged , Female , Femoral Artery/physiopathology , Follow-Up Studies , Humans , Male , Popliteal Artery/physiopathology , Prospective Studies , Treatment Outcome , Vascular Patency
3.
J Endovasc Ther ; 27(5): 693-705, 2020 10.
Article in English | MEDLINE | ID: mdl-32583749

ABSTRACT

Purpose: To report the 36-month outcomes from the prospective, multicenter, single-arm IN.PACT Global Study (ClinicalTrials.gov identifier NCT01609296) evaluating the performance of the IN.PACT Admiral drug-coated balloon (DCB) in real-world patients with femoropopliteal occlusive disease. Materials and Methods: The IN.PACT Global Study was conducted at 64 international sites and enrolled 1535 patients with complex lesions, which included bilateral disease, multiple lesions, de novo in-stent restenosis, long lesions, and chronic total occlusions. The predefined full clinical cohort included 1406 patients (mean age 68.6 years; 67.8% men) with claudication or rest pain treated with the study DCB. Mean lesion length was 12.09±9.54 cm; 18.0% had in-stent restenosis, 35.5% were totally occluded, and 68.7% were calcified. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated through 36 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization within 36 months. All safety and revascularization events were reviewed by an independent clinical events committee. Results: The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was 76.9%. The composite safety endpoint was achieved in 75.6% of patients. The 36-month all-cause mortality rate was 11.6%, and the major target limb amputation rate was 1.0%. The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was significantly lower in patients with chronic limb-threatening ischemia (CLTI) compared with claudicants (67.6% vs 78.0%; p=0.003). Lesions affecting both the superficial femoral artery (SFA) and popliteal artery had lower Kaplan-Meier freedom from CD-TLR through 36 months (69.2%) than either isolated SFA (79.7%) or popliteal artery lesions (76.5%; log- rank p<0.001). Predictors of CD-TLR through 36 months included increased lesion length, reference vessel diameter ≤4.5 mm, in-stent restenosis, bilateral disease, CLTI, and hyperlipidemia. Conclusion: DCB angioplasty with the IN.PACT Admiral DCB for femoropopliteal disease in a diverse and complex real-world population is associated with sustained clinical efficacy and low rates of reinterventions at 3 years after the initial procedure.


Subject(s)
Angioplasty, Balloon/instrumentation , Cardiovascular Agents/administration & dosage , Coated Materials, Biocompatible , Femoral Artery , Intermittent Claudication/therapy , Ischemia/therapy , Paclitaxel/administration & dosage , Peripheral Arterial Disease/therapy , Popliteal Artery , Aged , Angioplasty, Balloon/adverse effects , Cardiovascular Agents/adverse effects , Constriction, Pathologic , Female , Femoral Artery/diagnostic imaging , Femoral Artery/physiopathology , Humans , Intermittent Claudication/diagnostic imaging , Intermittent Claudication/physiopathology , Ischemia/diagnostic imaging , Ischemia/physiopathology , Limb Salvage , Male , Middle Aged , Paclitaxel/adverse effects , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/physiopathology , Popliteal Artery/diagnostic imaging , Popliteal Artery/physiopathology , Prospective Studies , Recovery of Function , Registries , Severity of Illness Index , Time Factors , Treatment Outcome , Vascular Patency
4.
Lancet ; 392(10157): 1541-1551, 2018 10 27.
Article in English | MEDLINE | ID: mdl-30262332

ABSTRACT

BACKGROUND: The clinical effect of a drug-eluting stent in the femoropopliteal segment has not been investigated in a randomised trial with a contemporary comparator. The IMPERIAL study sought to compare the safety and efficacy of the polymer-coated, paclitaxel-eluting Eluvia stent with the polymer-free, paclitaxel-coated Zilver PTX stent for treatment of femoropopliteal artery segment lesions. METHODS: In this randomised, single-blind, non-inferiority study, patients with symptomatic lower-limb ischaemia manifesting as claudication (Rutherford category 2, 3, or 4) with atherosclerotic lesions in the native superficial femoral artery or proximal popliteal artery were enrolled at 65 centres in Austria, Belgium, Canada, Germany, Japan, New Zealand, and the USA. Patients were randomly assigned (2:1) with a site-specific, web-based randomisation schedule to receive treatment with Eluvia or Zilver PTX. All patients, site personnel, and investigators were masked to treatment assignment until all patients had completed 12 months of follow-up. The primary efficacy endpoint was primary patency (defined as a peak systolic velocity ratio ≤2·4, without clinically driven target lesion revascularisation or bypass of the target lesion) and the primary safety endpoint was major adverse events (ie, all causes of death through 1 month, major amputation of target limb through 12 months, and target lesion revascularisation through 12 months). We set a non-inferiority margin of -10% at 12 months. Primary non-inferiority analyses were done when the minimum sample size required for adequate statistical power had completed 12 months of follow-up. The primary safety non-inferiority analysis included all patients who had completed 12 months of follow-up or had a major adverse event through 12 months. This trial is registered with ClinicalTrials.gov, number NCT02574481. FINDINGS: Between Dec 2, 2015, and Feb 15, 2017, 465 patients were randomly assigned to Eluvia (n=309) or to Zilver PTX (n=156). Non-inferiority was shown for both efficacy and safety endpoints at 12 months: primary patency was 86·8% (231/266) in the Eluvia group and 81·5% (106/130) in the Zilver PTX group (difference 5·3% [one-sided lower bound of 95% CI -0·66]; p<0·0001). 259 (94·9%) of 273 patients in the Eluvia group and 121 (91·0%) of 133 patients in the Zilver PTX group had not had a major adverse event at 12 months (difference 3·9% [one-sided lower bound of 95% CI -0·46]; p<0.0001). No deaths were reported in either group. One patient in the Eluvia group had a major amputation and 13 patients in each group required target lesion revascularisation. INTERPRETATION: The Eluvia stent was non-inferior to the Zilver PTX stent in terms of primary patency and major adverse events at 12 months after treatment of patients for femoropopliteal peripheral artery disease. FUNDING: Boston Scientific.


Subject(s)
Drug-Eluting Stents , Femoral Artery , Paclitaxel/administration & dosage , Peripheral Arterial Disease/therapy , Popliteal Artery , Tubulin Modulators/administration & dosage , Adult , Aged , Angiography , Endovascular Procedures/instrumentation , Endovascular Procedures/methods , Female , Femoral Artery/diagnostic imaging , Femoral Artery/pathology , Humans , Male , Middle Aged , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/pathology , Polymers , Popliteal Artery/diagnostic imaging , Popliteal Artery/pathology , Single-Blind Method , Surface Properties , Vascular Patency
5.
J Cardiovasc Surg (Torino) ; 59(4): 529-537, 2018 Aug.
Article in English | MEDLINE | ID: mdl-29790720

ABSTRACT

BACKGROUND: The aim of this study was to examine the safety and efficacy of the SoundBite™ Crossing System for the recanalization of infrainguinal chronic total occlusion (CTO) lesions. CTOs are frequent among patients with severe claudication or critical limb ischemia. Failure to recanalize CTOs remains common and is associated with poor prognosis. The SoundBite™ Crossing System (SoundBite Medical Solutions Inc., Montreal, QC, Canada) is a newly developed device that uses a 0.018-inch wire (SoundBite™ Active Wire) to deliver acoustic shock waves to the distal tip of a steerable guidewire to facilitate directed penetration of the proximal cap and crossing of the occlusion. METHODS: Symptomatic patients with de novo infrainguinal CTOs from 3 centers were enrolled in a prospective, single-arm feasibility study. The primary endpoint was 30-day device success defined as composite of technical success, defined as penetration and progression within the CTO with the SoundBite™ Active Wire followed by complete recanalization, and freedom from device-related major adverse events including death, urgent amputation, clinically-driven target vessel revascularization, perforation, type ≥C dissection, or distal embolization requiring intervention. RESULTS: Thirty-seven patients including 41 CTO lesions were enrolled in this study. CTO length ranged from 10 mm to 270 mm (mean 97.9±77.4 mm), and moderate-to-severe calcification was present in 24 (58.5%) of the treated lesions. CTOs were successfully crossed in 34 (91.9%) patients. No device-related adverse events occurred, resulting in a 30-day device success rate of 91.9%. Compared with baseline, 30-day ankle brachial index (0.66±0.24 versus 0.89±0.20; P<0.001) and Rutherford class (3 [2, 4] versus 0 [0, 1], P<0.001) significantly improved. CONCLUSIONS: The SoundBite™ Active Wire Crossing System feasibility study demonstrates a favorable safety and efficacy profile for the SoundBite™ Active Wire in infrainguinal CTOs.


Subject(s)
Arterial Occlusive Diseases/surgery , Endovascular Procedures/instrumentation , Femoral Artery , Vascular Access Devices , Aged , Angiography , Arterial Occlusive Diseases/diagnosis , Chronic Disease , Equipment Design , Female , Follow-Up Studies , Humans , Male , Prospective Studies , Treatment Outcome
6.
J Vasc Interv Radiol ; 29(4): 524-530.e2, 2018 04.
Article in English | MEDLINE | ID: mdl-29478796

ABSTRACT

PURPOSE: To investigate the current status and evolution of both the interventional radiologist's role as a clinician and the practice of interventional radiology (IR) over the past decade in Canada. MATERIALS AND METHODS: In 2015, an online survey was e-mailed to 210 interventional radiologists, including all Canadian active members of the Canadian Interventional Radiology Association (CIRA) and nonmembers who attended CIRA's annual meeting. Comparisons were made between interventional radiologists in academic versus community practice. The results of the 2015 survey were compared with CIRA's national surveys from 2005 and 2010. RESULTS: A total of 102 interventional radiologists responded (response rate 49%). Significantly more academic versus community interventional radiologists performed chemoembolization, transjugular intrahepatic portosystemic shunt, aortic interventions, and arteriovenous malformation embolization (P < .05). Ninety percent of respondents were involved in longitudinal patient care, which had increased by 42% compared with 2005; 46% of interventional radiologists had overnight admitting privileges, compared with 39% in 2010 and 29% in 2005. Eighty-six percent of interventional radiologists accepted direct referrals from family physicians, and 83% directly referred patients to other consultants. Sixty-three percent participated in multidisciplinary tumor board. The main challenges facing interventional radiologists included a lack of infrastructure, inadequate remuneration for IR procedures, and inadequate funding for IR equipment. Significantly more community versus academic interventional radiologists perceived work volume as an important issue facing the specialty in 2015 (60% vs 34%; P = .02). CONCLUSIONS: Over the past decade, many Canadian interventional radiologists have embraced the interventional radiologist-clinician role. However, a lack of infrastructure and funding continue to impede more widespread adoption of clinical IR practice.


Subject(s)
Radiology, Interventional/trends , Canada , Humans , Societies, Medical , Surveys and Questionnaires
7.
Urol Case Rep ; 13: 66-68, 2017 Jul.
Article in English | MEDLINE | ID: mdl-28462159

ABSTRACT

A 21 year-old male underwent nephrostomy tube insertion for hydronephrosis due to a large para-aortic adenopathy of a testicular tumor. In order to reduce infections during chemotherapy, a ureteral stent was placed. While removing the nephrostomy tube, a pulsatile bleeding was found and a renal angiography was done. A pseudoaneurysm of his first left lumbar (L1) artery communicating with the nephrostomy's access site was found. An embolization was performed with coils in the left L1 artery and one of its subdivisions. Post-embolization controls revealed no bleeding. On the follow-up CT, there were no suspicious retroperitoneal mass.

8.
J Invasive Cardiol ; 29(4): E47-E50, 2017 Apr.
Article in English | MEDLINE | ID: mdl-28368848

ABSTRACT

Chronic total occlusion (CTO) lesions are frequent in patients with peripheral and coronary artery disease, and associated with a higher risk of adverse events, including mortality, decreased quality of life, and increased health-care costs. Percutaneous intervention of CTO lesions has been associated with a lower procedural success rate, and current dedicated CTO devices may be of limited use for the non-CTO expert, and associated with increased intraprocedural complication rates. The SoundBite Crossing System (SoundBite Medical Solutions, Inc) is a newly developed device using shockwaves (short-duration, high-amplitude pressure pulses) to facilitate penetration of the proximal cap and crossing of the occlusion. The current report describes the first use of the SoundBite Crossing System in the recanalization of human ex vivo occluded arteries below the knee during a simulated procedure performed under fluoroscopy. Microcomputed tomography and histologic evaluation of the occluded and recanalized segment are provided to support therapeutic mechanism.


Subject(s)
Arterial Occlusive Diseases/surgery , Endovascular Procedures/instrumentation , Surgery, Computer-Assisted/methods , Tibial Arteries , Aged, 80 and over , Angiography , Arterial Occlusive Diseases/diagnosis , Chronic Disease , Equipment Design , Female , Fluoroscopy , Humans , X-Ray Microtomography
9.
Catheter Cardiovasc Interv ; 89(6): 1069-1077, 2017 May.
Article in English | MEDLINE | ID: mdl-28296239

ABSTRACT

OBJECTIVES: The SuperNOVA trial was designed to evaluate performance of the Innova Vascular Self-Expanding Stent System (Boston Scientific, Marlborough, MA) for treating lesions in the femoropopliteal arteries. METHODS: Patients with chronic lower limb peripheral artery disease (Rutherford category 2, 3, or 4) and atherosclerotic lesions in the native superficial femoral and/or proximal popliteal artery (lengths 30-190 mm) were enrolled in this single-arm, multinational study. Major adverse events (MAEs) were defined as all-cause death through 1 month, target limb major amputation, and target lesion revascularization (TLR). Vessel primary patency was defined as core laboratory-adjudicated duplex ultrasonography-derived peak systolic velocity ratio ≤2.4 in the absence of TLR, surgical bypass of the target lesion, or major amputation of the target limb. Primary safety and efficacy endpoints were evaluated at 12 months, with follow-up through 24 months also reported. RESULTS: SuperNOVA patients (N = 299; mean age 67.4 ± 9.7 years, 74% men, 41% with diabetes) had a mean lesion length of 93.2 mm. The MAE-free rate was 99.7% at 30 days, 85.8% at 12 months, and 77% at 24 months. Kaplan-Meier estimates of primary patency and TLR-free rates were 68.7% and 78.0%, respectively, at 24 months. Clinical improvements were sustained through 2 years, with 80% of patients displaying no or minimal symptoms (Rutherford category 0-1) at 24 months. CONCLUSIONS: In the SuperNOVA study, the Innova Stent System demonstrated an excellent safety profile and acceptable clinical outcomes despite the challenging anatomical characteristics of the lesions. © 2017 Wiley Periodicals, Inc.


Subject(s)
Angioplasty, Balloon/instrumentation , Femoral Artery , Peripheral Arterial Disease/therapy , Popliteal Artery , Self Expandable Metallic Stents , Aged , Alloys , Angioplasty, Balloon/adverse effects , Disease-Free Survival , Europe , Female , Femoral Artery/diagnostic imaging , Femoral Artery/physiopathology , Humans , Japan , Kaplan-Meier Estimate , Male , Middle Aged , North America , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/physiopathology , Popliteal Artery/diagnostic imaging , Popliteal Artery/physiopathology , Prospective Studies , Prosthesis Design , Risk Factors , Time Factors , Treatment Outcome , Ultrasonography, Doppler, Duplex , Vascular Patency
10.
J Invasive Cardiol ; 29(2): E17-E20, 2017 Feb.
Article in English | MEDLINE | ID: mdl-28145875

ABSTRACT

Chronic total occlusion (CTO) lesions are frequent in patients with peripheral and coronary artery disease, and are associated with a higher risk of adverse events, including mortality, decreased quality of life, and increased health-care costs. Percutaneous intervention of CTO lesions has been associated with a lower procedural success rate, and current dedicated CTO devices may be of limited use for non-CTO experts, and associated with increased intraprocedural complication rates. The SoundBite Crossing System (SoundBite Medical Solutions, Inc) is a newly-developed device using shockwaves (short-duration, high-amplitude pressure pulses) delivered to the tip of guidewire to facilitate penetration of the proximal cap and crossing of the occlusion. The current report describes the first-in-man use of the SoundBite Crossing System in the recanalization of two occluded lower-limb arteries.


Subject(s)
Angioplasty/instrumentation , Arterial Occlusive Diseases/surgery , Femoral Artery , Vascular Access Devices , Aged , Arterial Occlusive Diseases/diagnosis , Chronic Disease , Computed Tomography Angiography , Equipment Design , Humans , Male
12.
Can J Urol ; 16(4): 4765-9; discussion 4769, 2009 Aug.
Article in English | MEDLINE | ID: mdl-19671235

ABSTRACT

INTRODUCTION: Nutcracker syndrome (NCS) is a rare condition characterized by the entrapment of the left renal vein (LRV) between the superior mesenteric artery (SMA) and the aorta. It was first described in 1950 and the term nutcracker was attributed by de Schepper in 1972. CLINICAL CASE: A 20-year-old female patient was admitted to the urology department with a history of hematuria and left flank pain. Basic hematuria investigation was inconclusive. Further investigation revealed a nutcracker syndrome on retrograde phlebography. Surveillance was the option first chosen. Three years later and after several symptomatic episodes, an intravascular stenting procedure was performed. DISCUSSION: NCS is defined by the compression of the LRV between the SMA and the aorta. Clinical manifestations include left flank pain, hematuria and pelvic congestion syndrome (PCS). Diagnosis is based on history, physical examination, basic lab tests and imaging. Sequence of tests can be composed of Doppler ultrasound (DUS), computed tomography scan (CT scan) or magnetic resonance imaging study (MRI) and retrograde phlebography with pressure gradient to confirm the diagnosis. Management options include surveillance, intravascular and extravascular stenting procedures as well as open procedures. CONCLUSION: NCS is a rare condition that represents a challenge for urologists in terms of accurate diagnosis and proper management.


Subject(s)
Renal Veins/surgery , Stents , Vascular Diseases/surgery , Aorta, Abdominal , Female , Humans , Mesenteric Artery, Superior , Syndrome , Vascular Surgical Procedures/methods , Young Adult
14.
Can Assoc Radiol J ; 58(2): 79-87, 2007 Apr.
Article in English | MEDLINE | ID: mdl-17521052

ABSTRACT

The development of acute renal failure significantly complicates intravascular contrast medium (CM) use and is linked with high morbidity and mortality. The increasing use of CM, an aging population, and an increase in chronic kidney disease (CKD) will result in an increased incidence of contrast-induced nephropathy (CIN)-unless preventive measures are used. The Canadian Association of Radiologists has developed these guidelines as a practical approach to risk stratification and prevention of CIN. The major risk factor predicting CIN is preexisting CKD, which can be predicted from the glomerular filtration rate (GFR). In terms of being an absolute measure, serum creatinine (SCr) is an unreliable measure of renal function. Patients with GFR >60 mL/min have a very low risk of CIN, and preventive measures are generally unnecessary. When GFR is <60 mL/min, preventive measures should be instituted. The risk of CIN is greatest in patients with GFR <30 mL/min. Preventive measures: Alternative imaging that does not require CM should be considered. Fluid volume loading is the single most important protective measure. Nephrotoxic medications should be discontinued 48 hours prior to the study. CM volume and frequency of administration should be minimized, but satisfactory image quality should still be maintained. High-osmolar contrast should be avoided in patients with renal impairment. There is some evidence to suggest that iso-osmolar contrast reduces the risk of CIN among patients with renal impairment, but further study is necessary to determine whether iso-osmolar contrast is superior to low-osmolar contrast. Acetylcysteine (AC) has been advocated to reduce the incidence of CIN; however, not all studies have shown a benefit, and it is difficult to formulate evidence-based recommendations at this time. Its use may be considered in high-risk patients but is not considered mandatory.


Subject(s)
Acute Kidney Injury/prevention & control , Contrast Media/adverse effects , Acetylcysteine/therapeutic use , Adult , Aging , Child , Chronic Disease , Contrast Media/administration & dosage , Drug Interactions , Fluid Therapy , Free Radical Scavengers/therapeutic use , Glomerular Filtration Rate/physiology , Humans , Hypoglycemic Agents/adverse effects , Kidney Diseases/complications , Metformin/adverse effects , Renal Dialysis , Risk Assessment
15.
J Endovasc Ther ; 14(2): 158-67, 2007 Apr.
Article in English | MEDLINE | ID: mdl-17484531

ABSTRACT

PURPOSE: To examine in a canine model the feasibility of antegrade fenestration of abdominal aortic stent-grafts to preserve the patency of the renal arteries. METHODS: Two large dogs underwent antegrade fenestration of stent-grafts in the perirenal aorta. Before fenestration, bare stents were inserted in both renal arteries as fluoroscopic landmarks. A 12-mm iliac extension served as the canine aortic endograft. The first procedure was done under ultrasound and fluoroscopic guidance, using an intravascular ultrasound (IVUS) probe inserted in the vena cava and a Pioneer IVUS catheter. The second was performed exclusively under fluoroscopic guidance with a Brockenbrough needle. Angiograms and duplex ultrasound were planned for 1 month, after which the dogs would be sacrificed for autopsy. The explanted endograft was subjected to biomaterials analysis, with a focus on fabric tear. RESULTS: Perforation of the aortic graft and catheterization of the renal arteries with a floppy guidewire were possible in both animals. In dog 1, aortic graft dilation and subsequent fenestration were not possible, and the experiment was terminated. However, the procedure was successful in both renal arteries of dog 2. At 1-month follow-up in this dog, both renal arteries were patent. Stent fractures were observed bilaterally. There was no extension of the damage to the fabric beyond the area of fenestration. CONCLUSION: In vivo antegrade fenestration of aortic endografts is technically feasible. However, improvements in technique, instrumentation, and materials are required to make it a reliable and reproducible way of allowing stent-graft vascularization of aortic side branches.


Subject(s)
Aorta, Abdominal/surgery , Blood Vessel Prosthesis Implantation , Blood Vessel Prosthesis , Renal Artery/surgery , Stents , Animals , Aorta, Abdominal/diagnostic imaging , Aortography , Dogs , Feasibility Studies , Models, Animal , Prosthesis Design , Radiography, Interventional , Renal Artery/diagnostic imaging , Time Factors , Ultrasonography, Interventional , Vascular Patency
16.
Cancer ; 103(12): 2606-15, 2005 Jun 15.
Article in English | MEDLINE | ID: mdl-15880378

ABSTRACT

BACKGROUND: The treatment of malignant brain tumors is hampered by the presence of the blood-brain barrier, which limits chemotherapy penetration to the central nervous system (CNS). In recent years, different strategies have been designed to circumvent this physiologic barrier. The osmotic blood-brain barrier disruption (BBBD) procedure is one such strategy, and has been studied extensively in preclinical and clinical studies. The authors detail their experience so far with the procedure in the context of an open Phase II study in the treatment of malignant brain tumors. METHODS: Patients with histologically proven malignant gliomas, primitive neuroectodermal tumors, primary CNS lymphomas, and metastatic disease to the brain were eligible. Patients enrolled were treated every 4 weeks (1 cycle) for < or = 12 cycles. A methotrexate-based regimen was offered to patients with lymphomas, whereas a carboplatin-based regimen was offered to patients with all other histologies. Before intraarterial chemotherapy infusion, patients were submitted to an osmotic BBBD procedure. RESULTS: Seventy-two patients were included in the current report. The overall median survival times (MST) from treatment initiation for glioblastoma multiforme (GBM), anaplastic oligodendrogliomas, primary CNS lymphomas, and metastases were, respectively, 9.1, 13.9, not reached, and 9.9 months, whereas time to disease progression was 4.1, 9.2, 12.3, and 3.3 months. The MST from diagnosis was 32.2 months for GBM. CONCLUSIONS: These encouraging results prompted the authors to further refine their knowledge of the potential contribution of this procedure in the treatment of brain tumors. These authors designed a randomized Phase III study for patients with GBM that is now open.


Subject(s)
Antimetabolites, Antineoplastic/therapeutic use , Antineoplastic Agents/therapeutic use , Blood-Brain Barrier/drug effects , Brain Neoplasms/drug therapy , Carboplatin/therapeutic use , Infusions, Intra-Arterial , Methotrexate/therapeutic use , Adolescent , Adult , Aged , Astrocytoma/drug therapy , Astrocytoma/pathology , Brain Neoplasms/secondary , Child , Disease Progression , Drug Delivery Systems , Female , Glioblastoma/drug therapy , Glioblastoma/pathology , Humans , Lymphoma/drug therapy , Lymphoma/pathology , Male , Middle Aged , Neuroectodermal Tumors, Primitive/drug therapy , Neuroectodermal Tumors, Primitive/pathology , Oligodendroglioma/drug therapy , Oligodendroglioma/pathology , Survival Rate , Time Factors
17.
Radiographics ; 25(1): 157-73, 2005.
Article in English | MEDLINE | ID: mdl-15653593

ABSTRACT

The recent development of aortic stent-grafts has brought the management of thoracic aortic diseases into the realm of interventional radiology. Stent-graft placement is now an alternative to surgery for the treatment of descending thoracic aortic aneurysms, ulcers, and fistulas and is sometimes indicated in cases of mycotic aneurysm, posttraumatic aortic rupture, or thoracic descending aortic dissection. Pretreatment imaging is crucial for evaluating patient eligibility, selecting the appropriate stent-graft, and planning the intervention. Stent-graft treatment of long atherosclerotic aneurysms, lesions close to aortic branch vessels, and aortic dissections is subject to technical pitfalls, and adverse events such as endoleaks, stent migration or misplacement, aortic perforation, and vascular trauma will require specific interventions, although they occur in only a minority of patients. Thoracic stent-graft placement in good surgical candidates remains controversial because long-term results are unknown. However, short-term morbidity and mortality rates from endovascular treatment compare favorably with those from surgery, and stent-graft placement is proving to be a safe, minimally invasive, and effective treatment for thoracic aortic diseases and is already the best option in many affected patients who are poor surgical candidates.


Subject(s)
Aortic Diseases/surgery , Blood Vessel Prosthesis , Stents , Aorta, Thoracic , Blood Vessel Prosthesis/adverse effects , Combined Modality Therapy , Equipment Design , Humans , Prosthesis Design , Stents/adverse effects
18.
AJNR Am J Neuroradiol ; 25(5): 830-4, 2004 May.
Article in English | MEDLINE | ID: mdl-15140730

ABSTRACT

The blood-brain barrier disruption (BBBD) procedure is an established strategy to enhance drug delivery to brain tumors. Complication rates associated with this procedure are usually low, but when complications do occur, they usually mandate discontinuation of treatment. Orbital pseudotumor is an inflammatory condition of one or more extraocular muscles that produces limitation of ocular motility. Patients usually experience sudden diplopia associated with orbital pain, conjunctival chemosis and injection, and proptosis. Imaging of the orbit shows diffuse enlargement of the extraocular muscles, exophthalmia, and, rarely, sinusal or intracranial infiltration. On pathologic examinations, the soft tissues of the orbit are infiltrated with a mixture of eosinophils, lymphocytes, and plasma cells. Many etiologies can induce this syndrome, including the intracarotid infusion of platinum molecules. As part of a phase II study, a total of 110 patients were treated for malignant brain tumors with intra-arterial carboplatin, enhanced by the BBBD procedure, at the Sherbrooke University Hospital. Here we report on three patients who developed orbital pseudotumor ipsilateral to the carotid infused a few hours to days after the procedure. After the occurrence of this syndrome in the first patient, we developed a technical modification to the procedure that enabled uninterrupted treatment in the other two patients. This modification was as follows: after the mannitol infusion, and before carboplatin, the catheter was changed for a 3.5 tracker and was repositioned just above the emergence of the ophthalmic artery.


Subject(s)
Antineoplastic Agents/administration & dosage , Antineoplastic Agents/adverse effects , Carboplatin/administration & dosage , Carboplatin/adverse effects , Orbital Pseudotumor/chemically induced , Orbital Pseudotumor/prevention & control , Adult , Aged , Blood-Brain Barrier , Carotid Arteries , Female , Humans , Infusions, Intra-Arterial/methods , Male , Middle Aged , Osmosis , Recurrence
19.
Urology ; 62(5): 941, 2003 Nov.
Article in English | MEDLINE | ID: mdl-14624930

ABSTRACT

Pulsatile scrotal masses are extremely rare. We report the first case of pulsatile and painful scrotal mass that had an arterial collateral circulation, equivalent to an arterioarterial shunt, feeding an excluded internal iliac artery aneurysm after aortobifemoral bypass surgery.


Subject(s)
Collateral Circulation , Iliac Aneurysm/complications , Scrotum/blood supply , Aged , Aorta, Abdominal/surgery , Blood Vessel Prosthesis Implantation , Femoral Artery/surgery , Humans , Iliac Aneurysm/surgery , Iliac Artery/pathology , Iliac Artery/surgery , Male , Mesenteric Arteries/pathology , Pain/etiology , Postoperative Complications/etiology , Pulsatile Flow
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