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Subintimal recanalization of difficult iliac and femoral artery chronic total occlusions using a reentry device: a single-center experience
SUNDAY: Scientific Sessions
S18
’
Sunday
Scientific Session
Materials and Methods: A single center retrospective review was conducted to examine the long-term effects of stenting in patients diagnosed with TRAS resulting in acute, acute on chronic, or chronic kidney disease. Angiography was performed when there was either a clinical suspicion of TRAS or after MRA confirmed moderate to severe stenosis. The clinical diagnosis of TRAS was based on uncontrolled refractory or new-onset hypertension or azotemia and unexplained graft dysfunction in the absence of another diagnosis, such as rejection, obstruction, or infection. Between 12/2003 and 7/2012, 38 patients underwent stenting for TRAS. 24 males and 14 females, average age at stent placement was 56.2 years. Mean change in estimated glomerular filtration rate (eGFR) following intervention was used to determine the clinical success of transplant renal artery angiography and stenting. Results: The mean eGFR level in 38 patients with kidney dysfunction was 27.8 ⫾ 12.9 mL/min/1.73 m2 at the time of diagnosis of TRAS. After all patients were successfully treated with angiography and stent placement, the patients were evaluated six months later. The mean eGFR level increased to 38.0 ⫾ 12.0 mL/min/1.73 m2 (P ¼ 0.0004), making the mean reduction of 10.2 mL/min/1.73 m2 within six months statistically significant. Only one of the 38 patients required reintervention. No patient required re-transplantation. Conclusion: Transplant renal artery stenosis is a recognized complication of a transplanted kidney resulting in renal insufficiency. Transplant renal artery angioplasty and stenting demonstrates high clinical success with improvement in overall transplant renal function. Further studies are warranted to demonstrate long-term outcomes.
9:04 AM
Abstract No. 20
Clopidogrel resistance: a novel risk factor for repeat procedures after peripheral angioplasty or stenting S. Spiliopoulos, G. Pastromas, P. Kitrou, D. Karnabatidis, K. Katsanos, A. Diamantopoulos, D. Siablis; Interventional Radiology, Patras University Hospital, Patras, Greece Purpose: To investigate the incidence and clinical significance of platelet responsiveness in patients receiving clopidogrel following peripheral angioplasty procedures. Materials and Methods: This prospective study included patients receiving antiplatelet therapy with clopidogrel 75mg after infrainguinal angioplasty or stenting and who presented to our department during routine follow-up. Clopidogrel responsiveness was tested using the VerifyNowP2Y12 Assay. Patients with residual platelet reactivity units (PRU)Z235 were considered as non-responders (resistance to clopidogrel, group R), while patients with PRUo235 were considered as normal (group N). Primary endpoints were incidence of resistance to clopidogrel and target limb reintervention (TLR)-free survival, while secondary endpoints included limb salvage rates and the identification of any independent predictors influencing clinical outcomes. Results: In total, 113 consecutive patients (mean age 69⫾8years) with 139 limbs were enrolled. Following clopidogrel responsiveness analysis, 61 patients (53.9%) with 73 limbs (52.5%) were assigned to group R and 52 patients (46.1%) with 66 limbs (47.5%) to group N. Mean follow-up interval was 27.7⫾22.9 months(range:3-95months). Diabetes, critical limb ischemia and renal disease were associated with clopidogrel resistance (Fisher’s exact test;po0.05). According to the
’
JVIR
Kaplan-Meier analysis TLR-free survival was significantly superior in group N compared to group R (20.7% vs. 1.9% respectively, at 7 years follow-up;p¼0.001), while resistance to clopidogrel was identified as the only independent predictor of decreased TLR-free survival (HR: 0.536, 95%CI:0.31-0.90;p¼0.01). Cumulative TLR rate was significantly increased in group R compared to group N [71.2% (52/73) vs. 31.8% (21/66), respectively; po0.001)]. Limb salvage was similar in both groups. Conclusion: Resistance to clopidogrel was related with significantly more re-interventions following peripheral angioplasty procedures.
9:12 AM
Abstract No. 21
Preservation of the superior gluteal artery in patients with internal iliac artery aneurysm using iliac bifurcated device and viabahn stent grafts, a single institution experience T.L. Graham, K. Tan; University Health Network, Toronto, ON, Canada Purpose: To evaluate the feasibility and efficacy of extension of iliac branch graft (IBG) into the superior gluteal artery in endovascular repair of complex aortoiliac aneurysms Materials and Methods: From May 2009 to December 2012, 7 men (mean age 76 years, range 69-85 y) were treated with IBG with stent graft extension into the superior gluteal artery. Indications were abdominal aneurysm with internal iliac artery aneurysm (n¼5), repair of type III endoleak in a patient initially managed with EVAR and IBG alone (n¼1), and expanding internal iliac aneurysm in a patient treated with a surgical aortobifemoral graft (n¼1). Post-operative endoleak and patency rates were determined by CT (n¼7) within 4 weeks of placement, with clinical follow-up for symptoms of pelvic ischemia. Average follow-up was 3.5 months (range 1 month - 15 months). Results: Technical success, as defined by successful extension into the superior gluteal artery with no intraprocedural endoleak, was 100% (7/7). There were no cases of post-procedural endoleak. All stent-implanted internal iliac aneurysms remain stable in size, with no aneurysm rupture or death recorded. All superior gluteal artery stent grafts remain patent on follow-up CT angiography. None of the patients have new symptoms of pelvic ischemia. Conclusion: Preservation of the superior gluteal artery is technically feasible with excellent short-term results in treatment of patients with aortoiliac aneurysms. This technique presents an opportunity for preservation of pelvic perfusion in patients with complex anatomy not amenable to conventional IBG placement in the internal iliac artery.
9:20 AM
Abstract No. 22
Subintimal recanalization of difficult iliac and femoral artery chronic total occlusions using a reentry device: a single-center experience F. Berlin, R. Lookstein, A.M. Fischman, E. Kim, S. Ellozy, S. Nowakowski, R.S. Patel; Radiology, Mount Sinai, New York, NY Purpose: To present our experience with the technical outcome of the endovascular recanalization of occluded iliac and femoral arteries using Outback LTD reentry catheter when
JVIR
’
Scientific Session
Sunday
Scientific Session 3 Tumor Ablation I Sunday, April 14, 2013 1:30 PM – 3:00 PM Room: 288 1:30 PM
Abstract No. 23
Feasibility of high-intensity–focused ultrasound (HIFU) for treatment of polycystic ovarian syndrome: potential for noninvasive treatment I.A. Shehata,, J. Ballard, A. Casper, E. Cressman, E.S. Ebbini; 1College of Science and Engineering, University of Minnesota, Minneapolis, MN; 2Department of Radiodiagnosis and Interventional Radiology, Cairo University, Cairo, Egypt; 3Department of Diagnostic Radiology, University of Minnesota, Minneapolis, MN Purpose: Polycystic ovarian syndrome (PCOS) affects 5-10 % of females in the child bearing period and is a common cause of infertility in this population. Surgical treatment is indicated for
S19
patients resistant to medical management. We investigate the feasibility of using HIFU as a non-invasive treatment of PCOS. Materials and Methods: Ex-vivo canine ovaries fixed in gelatin were held in degassed water in front of an integrated 3.5 MHz dual mode ultrasound array (DMUA) system fenestrated to allow simultaneous use of a diagnostic transducer. DMUAs are transducers capable of imaging and treating with HIFU simultaneously using the same elements. Synthetic aperture (SA) and single transmit focus (STF) imaging were used to guide the treatment and HIFU shots (about 9-11 kW/cm2, 2 sec exposure time) were done at 6-7 mm depth. Ovaries were then sectioned and photographed to inspect the resultant damage. Results: Echogenic changes were observed on imaging at the focal spot. Localized damage ( 85 mm) was detected at the cortico-medullary interface; corresponding to the site of the echogenic changes. The ovarian surface was smooth and intact. SA imaging clearly showed the anatomical details of the ovaries. Conclusion: We report the first use of DMUAs for potential treatment of PCOS by HIFU. Results demonstrate the feasibility of inducing thermal damage in ovaries without significant damage to the ovarian surface. This could potentially reduce the incidence of post-operative pelvic adhesions. Further, it should be possible to apply HIFU through a transvaginal probe, thus eliminating the risk associated with laparoscopy. SA imaging provided high resolution imaging that can guide the treatment. Further research is still needed to refine the exposure parameters and provide histological characterization of the HIFU induced damage.
1:38 PM
Abstract No. 24
Increased risk of thrombosis following imageguided percutaneous cryoablation of renal tumors J.B. Hartman, N. Bhojwani, D. Corn, M.M. Cooney, A. Paspulati, J. Prologo; 1School of Medicine, Case Western Reserve University, Cleveland, OH; 2Department of Radiology, University Hospitals Case Medical Center, Cleveland, OH; 3Division of Hematology and Oncology, University Hospitals Case Medical Center, Cleveland, OH; 4 Case Western Reserve University, Cleveland, OH; 5 Division of Vascular and Interventional Radiology, University Hospitals Case Medical Center, Cleveland, OH Purpose: Hypercoagulable states have been described following cryotherapy. The purpose of this study is to determine if there is an increased incidence of thrombotic events in patients who undergo CT guided percutaneous renal tumor cryoablation. Materials and Methods: Data was collected through a retrospective chart review of all image-guided percutaneous cryoablations of renal tumors performed at our institution between September 2006 and June 2012; inclusion was limited to those patients having localized renal tumors and at least 30 days of follow up. Of these 128 patients, 25 had non-localized renal cancer, 9 lacked follow up data and 3 had their procedures aborted, excluding them from the study. The remaining sample consisted of 91 patients (total mean age ¼ 67.8), with 33 females (mean age ¼ 67; range: 34-87) and 58 males (mean age ¼ 69.4; range ¼ 31-88). The primary outcome was incidence of any thrombotic event within the first year post cryoablation. Patients’ medical records were examined for evidence of any type of thrombotic event. Incidence rates were calculated as cumulative incidence and as person-time (events per 100 patient-years).
SUNDAY: Scientific Sessions
conventional tools and techniques fail to reenter the true arterial lumen. Materials and Methods: A retrospective review was performed on 33 consecutive patients (25 men; mean age þ/- SD, 75 years þ/- 12) who underwent endovascular treatment for iliac and femoral arterial occlusions during a period of 67 months, from December 2006 to July 2012, at a single tertiary-care medical center. The Outback LTD reentry catheter was used to regain access into the true arterial lumen over a 0.014-in wire from the subintimal space following unsuccessful attempts with conventional guidewires. Immediate and late adverse effects (mean length of follow-up 12 months) were assessed. Results: Procedure outcome was improved by achieving true lumen reentry in 79% (n ¼ 26) of patients with iliac and femoral occlusions. Causes of failure included inability to re-enter the true lumen (n¼5), acute angle of aortic bifurcation (n¼1), and difficulty tracking the device through the lesion (n¼1). Encountered acute procedure-related complications included acute thrombosis of the CFA and SFA (n¼1), iliac artery perforation (n¼2), and distal embolization (n¼1). These complications were corrected immediately with endovascular techniques (n¼3) or open surgical embolectomy (n¼1), without any procedure-related late adverse effects. Conclusion: This study shows that use of reentry catheters significantly improves the outcome of endovascular treatments in patients who otherwise would have required surgical intervention with its associated higher morbidity, cost, and hospital stay with no long term adverse effects. The incidence of iliac complications is concerning, however the majority of complications could be managed with endovascular techniques. In conclusion, the Outback LTD reentry catheter is an effective endovascular tool, the use of which enhances the likelihood of successful subintimal recanalization of chronic occlusions in iliac and femoral arteries.
’
S18
’
Sunday
Scientific Session
Materials and Methods: A single center retrospective review was conducted to examine the long-term effects of stenting in patients diagnosed with TRAS resulting in acute, acute on chronic, or chronic kidney disease. Angiography was performed when there was either a clinical suspicion of TRAS or after MRA confirmed moderate to severe stenosis. The clinical diagnosis of TRAS was based on uncontrolled refractory or new-onset hypertension or azotemia and unexplained graft dysfunction in the absence of another diagnosis, such as rejection, obstruction, or infection. Between 12/2003 and 7/2012, 38 patients underwent stenting for TRAS. 24 males and 14 females, average age at stent placement was 56.2 years. Mean change in estimated glomerular filtration rate (eGFR) following intervention was used to determine the clinical success of transplant renal artery angiography and stenting. Results: The mean eGFR level in 38 patients with kidney dysfunction was 27.8 ⫾ 12.9 mL/min/1.73 m2 at the time of diagnosis of TRAS. After all patients were successfully treated with angiography and stent placement, the patients were evaluated six months later. The mean eGFR level increased to 38.0 ⫾ 12.0 mL/min/1.73 m2 (P ¼ 0.0004), making the mean reduction of 10.2 mL/min/1.73 m2 within six months statistically significant. Only one of the 38 patients required reintervention. No patient required re-transplantation. Conclusion: Transplant renal artery stenosis is a recognized complication of a transplanted kidney resulting in renal insufficiency. Transplant renal artery angioplasty and stenting demonstrates high clinical success with improvement in overall transplant renal function. Further studies are warranted to demonstrate long-term outcomes.
9:04 AM
Abstract No. 20
Clopidogrel resistance: a novel risk factor for repeat procedures after peripheral angioplasty or stenting S. Spiliopoulos, G. Pastromas, P. Kitrou, D. Karnabatidis, K. Katsanos, A. Diamantopoulos, D. Siablis; Interventional Radiology, Patras University Hospital, Patras, Greece Purpose: To investigate the incidence and clinical significance of platelet responsiveness in patients receiving clopidogrel following peripheral angioplasty procedures. Materials and Methods: This prospective study included patients receiving antiplatelet therapy with clopidogrel 75mg after infrainguinal angioplasty or stenting and who presented to our department during routine follow-up. Clopidogrel responsiveness was tested using the VerifyNowP2Y12 Assay. Patients with residual platelet reactivity units (PRU)Z235 were considered as non-responders (resistance to clopidogrel, group R), while patients with PRUo235 were considered as normal (group N). Primary endpoints were incidence of resistance to clopidogrel and target limb reintervention (TLR)-free survival, while secondary endpoints included limb salvage rates and the identification of any independent predictors influencing clinical outcomes. Results: In total, 113 consecutive patients (mean age 69⫾8years) with 139 limbs were enrolled. Following clopidogrel responsiveness analysis, 61 patients (53.9%) with 73 limbs (52.5%) were assigned to group R and 52 patients (46.1%) with 66 limbs (47.5%) to group N. Mean follow-up interval was 27.7⫾22.9 months(range:3-95months). Diabetes, critical limb ischemia and renal disease were associated with clopidogrel resistance (Fisher’s exact test;po0.05). According to the
’
JVIR
Kaplan-Meier analysis TLR-free survival was significantly superior in group N compared to group R (20.7% vs. 1.9% respectively, at 7 years follow-up;p¼0.001), while resistance to clopidogrel was identified as the only independent predictor of decreased TLR-free survival (HR: 0.536, 95%CI:0.31-0.90;p¼0.01). Cumulative TLR rate was significantly increased in group R compared to group N [71.2% (52/73) vs. 31.8% (21/66), respectively; po0.001)]. Limb salvage was similar in both groups. Conclusion: Resistance to clopidogrel was related with significantly more re-interventions following peripheral angioplasty procedures.
9:12 AM
Abstract No. 21
Preservation of the superior gluteal artery in patients with internal iliac artery aneurysm using iliac bifurcated device and viabahn stent grafts, a single institution experience T.L. Graham, K. Tan; University Health Network, Toronto, ON, Canada Purpose: To evaluate the feasibility and efficacy of extension of iliac branch graft (IBG) into the superior gluteal artery in endovascular repair of complex aortoiliac aneurysms Materials and Methods: From May 2009 to December 2012, 7 men (mean age 76 years, range 69-85 y) were treated with IBG with stent graft extension into the superior gluteal artery. Indications were abdominal aneurysm with internal iliac artery aneurysm (n¼5), repair of type III endoleak in a patient initially managed with EVAR and IBG alone (n¼1), and expanding internal iliac aneurysm in a patient treated with a surgical aortobifemoral graft (n¼1). Post-operative endoleak and patency rates were determined by CT (n¼7) within 4 weeks of placement, with clinical follow-up for symptoms of pelvic ischemia. Average follow-up was 3.5 months (range 1 month - 15 months). Results: Technical success, as defined by successful extension into the superior gluteal artery with no intraprocedural endoleak, was 100% (7/7). There were no cases of post-procedural endoleak. All stent-implanted internal iliac aneurysms remain stable in size, with no aneurysm rupture or death recorded. All superior gluteal artery stent grafts remain patent on follow-up CT angiography. None of the patients have new symptoms of pelvic ischemia. Conclusion: Preservation of the superior gluteal artery is technically feasible with excellent short-term results in treatment of patients with aortoiliac aneurysms. This technique presents an opportunity for preservation of pelvic perfusion in patients with complex anatomy not amenable to conventional IBG placement in the internal iliac artery.
9:20 AM
Abstract No. 22
Subintimal recanalization of difficult iliac and femoral artery chronic total occlusions using a reentry device: a single-center experience F. Berlin, R. Lookstein, A.M. Fischman, E. Kim, S. Ellozy, S. Nowakowski, R.S. Patel; Radiology, Mount Sinai, New York, NY Purpose: To present our experience with the technical outcome of the endovascular recanalization of occluded iliac and femoral arteries using Outback LTD reentry catheter when
JVIR
’
Scientific Session
Sunday
Scientific Session 3 Tumor Ablation I Sunday, April 14, 2013 1:30 PM – 3:00 PM Room: 288 1:30 PM
Abstract No. 23
Feasibility of high-intensity–focused ultrasound (HIFU) for treatment of polycystic ovarian syndrome: potential for noninvasive treatment I.A. Shehata,, J. Ballard, A. Casper, E. Cressman, E.S. Ebbini; 1College of Science and Engineering, University of Minnesota, Minneapolis, MN; 2Department of Radiodiagnosis and Interventional Radiology, Cairo University, Cairo, Egypt; 3Department of Diagnostic Radiology, University of Minnesota, Minneapolis, MN Purpose: Polycystic ovarian syndrome (PCOS) affects 5-10 % of females in the child bearing period and is a common cause of infertility in this population. Surgical treatment is indicated for
S19
patients resistant to medical management. We investigate the feasibility of using HIFU as a non-invasive treatment of PCOS. Materials and Methods: Ex-vivo canine ovaries fixed in gelatin were held in degassed water in front of an integrated 3.5 MHz dual mode ultrasound array (DMUA) system fenestrated to allow simultaneous use of a diagnostic transducer. DMUAs are transducers capable of imaging and treating with HIFU simultaneously using the same elements. Synthetic aperture (SA) and single transmit focus (STF) imaging were used to guide the treatment and HIFU shots (about 9-11 kW/cm2, 2 sec exposure time) were done at 6-7 mm depth. Ovaries were then sectioned and photographed to inspect the resultant damage. Results: Echogenic changes were observed on imaging at the focal spot. Localized damage ( 85 mm) was detected at the cortico-medullary interface; corresponding to the site of the echogenic changes. The ovarian surface was smooth and intact. SA imaging clearly showed the anatomical details of the ovaries. Conclusion: We report the first use of DMUAs for potential treatment of PCOS by HIFU. Results demonstrate the feasibility of inducing thermal damage in ovaries without significant damage to the ovarian surface. This could potentially reduce the incidence of post-operative pelvic adhesions. Further, it should be possible to apply HIFU through a transvaginal probe, thus eliminating the risk associated with laparoscopy. SA imaging provided high resolution imaging that can guide the treatment. Further research is still needed to refine the exposure parameters and provide histological characterization of the HIFU induced damage.
1:38 PM
Abstract No. 24
Increased risk of thrombosis following imageguided percutaneous cryoablation of renal tumors J.B. Hartman, N. Bhojwani, D. Corn, M.M. Cooney, A. Paspulati, J. Prologo; 1School of Medicine, Case Western Reserve University, Cleveland, OH; 2Department of Radiology, University Hospitals Case Medical Center, Cleveland, OH; 3Division of Hematology and Oncology, University Hospitals Case Medical Center, Cleveland, OH; 4 Case Western Reserve University, Cleveland, OH; 5 Division of Vascular and Interventional Radiology, University Hospitals Case Medical Center, Cleveland, OH Purpose: Hypercoagulable states have been described following cryotherapy. The purpose of this study is to determine if there is an increased incidence of thrombotic events in patients who undergo CT guided percutaneous renal tumor cryoablation. Materials and Methods: Data was collected through a retrospective chart review of all image-guided percutaneous cryoablations of renal tumors performed at our institution between September 2006 and June 2012; inclusion was limited to those patients having localized renal tumors and at least 30 days of follow up. Of these 128 patients, 25 had non-localized renal cancer, 9 lacked follow up data and 3 had their procedures aborted, excluding them from the study. The remaining sample consisted of 91 patients (total mean age ¼ 67.8), with 33 females (mean age ¼ 67; range: 34-87) and 58 males (mean age ¼ 69.4; range ¼ 31-88). The primary outcome was incidence of any thrombotic event within the first year post cryoablation. Patients’ medical records were examined for evidence of any type of thrombotic event. Incidence rates were calculated as cumulative incidence and as person-time (events per 100 patient-years).
SUNDAY: Scientific Sessions
conventional tools and techniques fail to reenter the true arterial lumen. Materials and Methods: A retrospective review was performed on 33 consecutive patients (25 men; mean age þ/- SD, 75 years þ/- 12) who underwent endovascular treatment for iliac and femoral arterial occlusions during a period of 67 months, from December 2006 to July 2012, at a single tertiary-care medical center. The Outback LTD reentry catheter was used to regain access into the true arterial lumen over a 0.014-in wire from the subintimal space following unsuccessful attempts with conventional guidewires. Immediate and late adverse effects (mean length of follow-up 12 months) were assessed. Results: Procedure outcome was improved by achieving true lumen reentry in 79% (n ¼ 26) of patients with iliac and femoral occlusions. Causes of failure included inability to re-enter the true lumen (n¼5), acute angle of aortic bifurcation (n¼1), and difficulty tracking the device through the lesion (n¼1). Encountered acute procedure-related complications included acute thrombosis of the CFA and SFA (n¼1), iliac artery perforation (n¼2), and distal embolization (n¼1). These complications were corrected immediately with endovascular techniques (n¼3) or open surgical embolectomy (n¼1), without any procedure-related late adverse effects. Conclusion: This study shows that use of reentry catheters significantly improves the outcome of endovascular treatments in patients who otherwise would have required surgical intervention with its associated higher morbidity, cost, and hospital stay with no long term adverse effects. The incidence of iliac complications is concerning, however the majority of complications could be managed with endovascular techniques. In conclusion, the Outback LTD reentry catheter is an effective endovascular tool, the use of which enhances the likelihood of successful subintimal recanalization of chronic occlusions in iliac and femoral arteries.
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