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Abstract No. 170: Five year outcomes of drug eluting stents in renal artery stenosis
JVIR 䡲 Scientific Sessions
Tuesday 䡲 S73
Conclusion: Based on these preliminary data, UFE appears to significantly improve LUTS and urinary-related QoL with no effect on incontinence. Obesity seems to attenuate this effect.
3:06 PM
Abstract No. 169
Comparison of polyvinyl alcohol and tris-acryl gelatin microspheres for uterine fibroid embolization: Results of a single-center randomized study R. Shlansky-Goldberg1, M. Rosen1, J. Mondschein1, W. Stavropoulos1, S. Trerotola1, J. Diaz-Cartelle2; 1 Hospital of the University of Pennsylvania, Philadelphia, PA; 2Boston Scientific, Marlborough, MA Purpose: To assess the efficacy of 2 embolic agents in treating symptomatic fibroids. Fibroids are the most common benign pelvic tumor successfully treated by uterine fibroid embolization (UFE). There is considerable interest in the shape, type and performance of embolic material. We will present 24 hour (h), 3and 12-month (mo) outcomes after treatment with polyvinylalcohol microspheres (sPVA) versus tris-acryl gelatin microspheres (EMS). sPVA Patients with ⱖ91%-⬎99% infarction Patients with 100% infarction
3:18 PM
⫺48.4⫾26.2 48.2⫾25.0
45.9⫾26.9
13.8% 86.2%
Abstract No. 170
Five year outcomes of drug eluting stents in renal artery stenosis R. Pannu, M.A. McKusick, G. Oderich, S. Misra; Mayo Clinic, Rochester, MN Purpose: Drug eluting stents (DES) are used for treatment of stenosis involving the coronary arteries. There have been reports describing the use of DES for the treatment of atherosclerotic renal artery stenosis (RAS). We present the clinical outcomes and primary patency rates of patients treated with DES for atherosclerotic RAS in arteries ⱕ 4mm of diameter. Materials and Methods: We performed a retrospective chart review of patients treated with DES for RAS over 5 years. The primary endpoints included death, loss of primary patency, change in blood pressure (BP), number of anti-hypertensive medications, hemodialysis (HD), or renal transplantation during the time of follow-up. Results: 34 patients ((22 females), mean age 71 years ⫾ 10) underwent treatment of 58 RAS for worsening renal function (n⫽26) and uncontrolled hypertension (n⫽22). Forty six renal
P value
sPVA
EMS
1.00 0.35
10.7% 82.1%
0.16
⫺45.4⫾24.9
3 months 3.6% 85.7% 12 months ⫺41.2⫾24.3
0.99
47.5⫾24.4
47.2⫾26.4
P value 0.61 1.00 0.47 0.49
arteries (RA) with ⱕ 4mm diameter were treated with DES (28 sirolimus coated stents, 13 paclitaxel coated stents, and 5 everolimus coated stents) with a mean diameter of 3.44 ⫾ 0.05 mm and a mean length of 16.02 ⫾ 5.67 mm. The average follow-up was 30 ⫾ 23 months. Post procedure, mean systolic BP decreased by 27mmHg (P ⬍ 0.0001), mean diastolic BP decreased 6mmHg (P ⫽ 0.0078), and the mean of number of anti-hypertensive medications decreased by 0.5 medication (P ⫽ 0.0037). No significant changes in mean serum creatinine, kidney size, or resistive index noted. By Kaplan-Meier estimates, the primary patency of DES was 69.8% at 54 months (SE⫽ 0.0998). Of the 34 patients, 4 died due to cardiovascular events (1⬍30days, 3⬎30days); 1 patient developed post intervention RA spasm and was started on chronic HD; 2 patients were started on chronic HD 6 months post intervention; 1 patient was on HD for less than 30 days; two developed transient acute renal failure after intervention, likely contrast related. Conclusion: Treatment of stenoses involving the renal artery can be achieved with DESs with good restenosis results; Prospective randomized trials are needed to evaluate use of DESs in renal artery stenosis treatment.
TUESDAY: Scientific Sessions
Uterine Fibroid-specific Quality of Life Symptom Score change from baseline Fibroid-specific Health-related Quality of Life Subscales change from baseline
EMS 24 hours 16.7% 76.7% 3 months ⫺41.4⫾26.7
Materials and Methods: This was a randomized, prospective, single-center study enrolling 60 women with symptomatic fibroids. UFE with sPVA (Contour SETM; N⫽30; 700 –900i and 900 –1200i using a near stasis or stasis endpoint) and EMS (EmbosphereTM; N⫽30; 500 –700 using a “pruned tree” endpoint) was performed. Infarction rates were calculated for dominant fibroid (DF), small ⬍2 cm non-dominant fibroids (SNDF) and large ⬎2 cm non-dominant fibroids (LNDF). Currently, 75% of patients have been followed for 12 months. The primary endpoint was fibroid devascularization at 24 h measured by contrastenhanced MRI assessed by a blinded reviewer. Results: Baseline characteristics were similar between groups. The primary endpoint was comparable between treatments (ⱕ91% DF infarction: sPVA 100% vs EMS 93.3%, P⬍0.001). Complete infarction (100%) was also similar between arms at 24 h and 3 mo (Table). SNDF and LNDF infarction were similar, (P⫽0.30 and P⫽0.51, respectively at 24 h, P⫽0.78 and P⫽0.59 at 3 mo). Symptom severity was reduced and quality of life improved to the same degree at 3 and 12-mo in each cohort (Table). Secondary 12-mo outcomes will be complete by the time of the presentation. Conclusion: Fibroid devascularization at 24h after treatment with sPVA or EMS microspheres can be considered comparable when using stasis as an endpoint with sPVA. The clinical effects are so far maintained up to 12 mo.
Tuesday 䡲 S73
Conclusion: Based on these preliminary data, UFE appears to significantly improve LUTS and urinary-related QoL with no effect on incontinence. Obesity seems to attenuate this effect.
3:06 PM
Abstract No. 169
Comparison of polyvinyl alcohol and tris-acryl gelatin microspheres for uterine fibroid embolization: Results of a single-center randomized study R. Shlansky-Goldberg1, M. Rosen1, J. Mondschein1, W. Stavropoulos1, S. Trerotola1, J. Diaz-Cartelle2; 1 Hospital of the University of Pennsylvania, Philadelphia, PA; 2Boston Scientific, Marlborough, MA Purpose: To assess the efficacy of 2 embolic agents in treating symptomatic fibroids. Fibroids are the most common benign pelvic tumor successfully treated by uterine fibroid embolization (UFE). There is considerable interest in the shape, type and performance of embolic material. We will present 24 hour (h), 3and 12-month (mo) outcomes after treatment with polyvinylalcohol microspheres (sPVA) versus tris-acryl gelatin microspheres (EMS). sPVA Patients with ⱖ91%-⬎99% infarction Patients with 100% infarction
3:18 PM
⫺48.4⫾26.2 48.2⫾25.0
45.9⫾26.9
13.8% 86.2%
Abstract No. 170
Five year outcomes of drug eluting stents in renal artery stenosis R. Pannu, M.A. McKusick, G. Oderich, S. Misra; Mayo Clinic, Rochester, MN Purpose: Drug eluting stents (DES) are used for treatment of stenosis involving the coronary arteries. There have been reports describing the use of DES for the treatment of atherosclerotic renal artery stenosis (RAS). We present the clinical outcomes and primary patency rates of patients treated with DES for atherosclerotic RAS in arteries ⱕ 4mm of diameter. Materials and Methods: We performed a retrospective chart review of patients treated with DES for RAS over 5 years. The primary endpoints included death, loss of primary patency, change in blood pressure (BP), number of anti-hypertensive medications, hemodialysis (HD), or renal transplantation during the time of follow-up. Results: 34 patients ((22 females), mean age 71 years ⫾ 10) underwent treatment of 58 RAS for worsening renal function (n⫽26) and uncontrolled hypertension (n⫽22). Forty six renal
P value
sPVA
EMS
1.00 0.35
10.7% 82.1%
0.16
⫺45.4⫾24.9
3 months 3.6% 85.7% 12 months ⫺41.2⫾24.3
0.99
47.5⫾24.4
47.2⫾26.4
P value 0.61 1.00 0.47 0.49
arteries (RA) with ⱕ 4mm diameter were treated with DES (28 sirolimus coated stents, 13 paclitaxel coated stents, and 5 everolimus coated stents) with a mean diameter of 3.44 ⫾ 0.05 mm and a mean length of 16.02 ⫾ 5.67 mm. The average follow-up was 30 ⫾ 23 months. Post procedure, mean systolic BP decreased by 27mmHg (P ⬍ 0.0001), mean diastolic BP decreased 6mmHg (P ⫽ 0.0078), and the mean of number of anti-hypertensive medications decreased by 0.5 medication (P ⫽ 0.0037). No significant changes in mean serum creatinine, kidney size, or resistive index noted. By Kaplan-Meier estimates, the primary patency of DES was 69.8% at 54 months (SE⫽ 0.0998). Of the 34 patients, 4 died due to cardiovascular events (1⬍30days, 3⬎30days); 1 patient developed post intervention RA spasm and was started on chronic HD; 2 patients were started on chronic HD 6 months post intervention; 1 patient was on HD for less than 30 days; two developed transient acute renal failure after intervention, likely contrast related. Conclusion: Treatment of stenoses involving the renal artery can be achieved with DESs with good restenosis results; Prospective randomized trials are needed to evaluate use of DESs in renal artery stenosis treatment.
TUESDAY: Scientific Sessions
Uterine Fibroid-specific Quality of Life Symptom Score change from baseline Fibroid-specific Health-related Quality of Life Subscales change from baseline
EMS 24 hours 16.7% 76.7% 3 months ⫺41.4⫾26.7
Materials and Methods: This was a randomized, prospective, single-center study enrolling 60 women with symptomatic fibroids. UFE with sPVA (Contour SETM; N⫽30; 700 –900i and 900 –1200i using a near stasis or stasis endpoint) and EMS (EmbosphereTM; N⫽30; 500 –700 using a “pruned tree” endpoint) was performed. Infarction rates were calculated for dominant fibroid (DF), small ⬍2 cm non-dominant fibroids (SNDF) and large ⬎2 cm non-dominant fibroids (LNDF). Currently, 75% of patients have been followed for 12 months. The primary endpoint was fibroid devascularization at 24 h measured by contrastenhanced MRI assessed by a blinded reviewer. Results: Baseline characteristics were similar between groups. The primary endpoint was comparable between treatments (ⱕ91% DF infarction: sPVA 100% vs EMS 93.3%, P⬍0.001). Complete infarction (100%) was also similar between arms at 24 h and 3 mo (Table). SNDF and LNDF infarction were similar, (P⫽0.30 and P⫽0.51, respectively at 24 h, P⫽0.78 and P⫽0.59 at 3 mo). Symptom severity was reduced and quality of life improved to the same degree at 3 and 12-mo in each cohort (Table). Secondary 12-mo outcomes will be complete by the time of the presentation. Conclusion: Fibroid devascularization at 24h after treatment with sPVA or EMS microspheres can be considered comparable when using stasis as an endpoint with sPVA. The clinical effects are so far maintained up to 12 mo.