Endovascular intervention

TUESDAY 9/16/03 9:00 –11:00

AM

and 2:00 – 4:00

Endovascular Intervention Tuesday, September 16, 2003 9:00 –11:00 AM 2:00 – 4:00 PM Exhibit Hall B on the Lower Level (Abstract nos. 361–374)

TCT-361 Percutaneous Peripheral Intervention for Treatment of Claudication is Associated with Sustained Improvement in Health-Related Quality of Life. R.A. Corpus, J.A. House, S.B. Laster, W.C. Daniels, S.P. Marso. Mid-America Heart Institute, Kansas City, Missouri, USA. Background: Despite a burgeoning of percutaneous peripheral interventions (PPIs) for treatment of lifestyle-limiting claudication, there are few data substantiating the benefit of such procedures. The Peripheral Arterial Questionnaire (PAQ) is a recently developed and validated 20-item selfadministered Likert-style instrument that assesses function and quality-oflife limitations specifically caused by peripheral arterial disease. Methods: Health-related quality-of-life assessments using the PAQ were performed on 216 consecutive patients undergoing lower extremity PPI for treatment of lifestyle-limiting claudication at baseline and at 1, 3, 6, and 12 months after the index procedure. Results: Of the 216 patients undergoing PPI, 130 (63%) were men,

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(Exhibit Hall B on the Lower Level)

TCT-362 Drug-Eluting Stents for the Treatment of Obstructive Disease in Infrapopliteal Arteries. A. Schmidt, S. Ropers, S. Braunlich, G. Biamino, D. Scheinert. Clinical and Interventional Angiology, Department of Cardiology, University of Leipzig Heart Center, Leipzig, Sachsen, Germany. Background: Stent implantation for obstructive disease of the infrapopliteal arteries has been associated with a considerable rate of restenosis. Drug-eluting stents seem to be a breakthrough in prevention of restenosis as it has already impressively shown for coronary arteries. We describe the first experience with drug-eluting stents in peripheral arteries below the knee. The primary objective of this registry is to assess the safety and feasibility of drug-eluting stents in infrapopliteal arteries and to determine the restenosis rate angiographically and by intravascular ultrasound (IVUS) at 6-month follow-up. Methods: Between September 2002 and January 2003, 15 patients (7 men, 8 women; mean age, 66 years) with peripheral artery obstructive disease, including infrapopliteal lesions in clinical stage 3 to 6 according to the Rutherford classification were enrolled. At our center, 22 drug-eluting stents (JOSTENT FlexALOJM2 3.0/16 or 3.5/16 mm; JOMED, Rangendingen, Germany) were implanted in 15 stenoses in the anterior (n ⫽ 5) or peroneal (n ⫽ 2) artery or the tibioperoneal trunk (n ⫽ 8). The reference vessel diameter varied between 3.0 and 3.5 mm, the lesion length was 5 to 30 mm. The stent was a stainless steel coronary stent, coated with an aluminumoxide layer embedding the drug FK506 (Takrolimus) in a dose of 230 ␮g per stent. Stent implantation was followed by an IVUS examination. Results: There were no adverse events related to implantation of a drug-eluting stent. All patients were enrolled in a 6-month-follow-up protocol, and 3-month clinical and Doppler sonographic follow-up results are currently available. All 15 patients reported sustained improvement of their condition. A 6-month angiographic and IVUS follow-up is expected. No BP Post

6-month

Prox edge-stent lumen 34.6 ⫾ 11.8 39.9 ⫾ 18.8 Prox edge-stent plaque 27.9 ⫾ 12.4 30.9 ⫾ 14.7 Prox edge-stent vessel 62.5 ⫾ 18.9 70.8 ⫾ 26.6 %Prox plaque burden 44.1 ⫾ 13.4 43.9 ⫾ 15.9 Distal edge-stent lumen 32.6 ⫾ 12.6 36.8 ⫾ 15.0 Distal edge-stent plaque 20.2 ⫾ 10.5 20.9 ⫾ 10.9 Distal edge-stent vessel 52.8 ⫾ 17.9 57.7 ⫾ 21.2 %distal plaque burden 37.4 ⫾ 12.5 35.9 ⫾ 12.6 In-stint Lumen 120.4 ⫾ 32.6 128.4 ⫾ 38.5 Plaque behind Stent 131.5 ⫾ 56.9 136.1 ⫾ 49.0 Vessel behind Stent 251.8 ⫾ 80.4 264.9 ⫾ 76.8 Intimal hyperplasia – 0.39 ⫾ 1.6 %Obstruction – 0.38 ⫾ 1.5

BP p

Post

6-month

0.2 33.8 ⫾ 13.0 36.6 ⫾ 15.8 0.1 34.3 ⫾ 13.2 38.0 ⫾ 17.6 0.06 68.1 ⫾ 17.7 74.7 ⫾ 24.6 0.9 49.9 ⫾ 15.6 50.3 ⫾ 16.2 0.1 29.1 ⫾ 12.2 33.8 ⫾ 15.2 0.5 19.6 ⫾ 12.6 21.9 ⫾ 14.0 0.2 48.8 ⫾ 20.0 55.7 ⫾ 24.8 0.3 38.3 ⫾ 18.6 37.1 ⫾ 16.2 0.3 117.0 ⫾ 33.5 125.1 ⫾ 40.7 0.6 144.7 ⫾ 62.2 152.2 ⫾ 73.3 0.4 261.8 ⫾ 86.8 279.9 ⫾ 103.6 NA – 2.6 ⫾ 7.1 NA – 2.7 ⫾ 8.0

p 0.07 0.08 0.02 0.8 0.04 0.1 0.02 0.6 0.2 0.1 0.04 NA NA

p ⫽ NS versus BP. Conclusion: The implantation of drug-eluting stents in arteries below the knee is feasible and safe. According to short-term clinical data, the use of these stents will improve treatment of complex tibial lesions in patients who are often poor candidates for vascular surgery. 79 (38%) had diabetes, 129 (64%) dyslipidemia, 134 (67%), and hypertension; 96 (46%) were current smokers and the mean age was 68 ⫾ 12 years. Angiographically, 58 (28%) of patients had bilateral disease, 104 (45%) had multilevel disease, and 46 (22%) had total occlusions. At 6 months after PPI, there was a significant and sustained improvement in health-related quality of life (p ⬍0.001 for trend). Conclusion: These data suggest that PPI for the treatment of lifestyle-limiting claudication is effective and associated with a significant and sustained improvement in quality of life.

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TCT-363 Endoluminal Stenting for Obstructive Lesions of the Subclavian Artery: Multicenter Subclavian Artery Registry in Japan. S. Nakamura1, M. Hirose1, E. Saito1, T. Miyauchi1, A. Kanazawa1, K. Hozawa2, H. Nakamura2, K. Yamamoto2, N. Makishima3, S. Nakamura4, J. Koyama4. 1New Tokyo Hospital, Matsudo, Japan; 2 Kasori Hospital, Chiba, Japan; 3Kobari General Hospital, Noda, Japan; 4Secomedic Hospital, Funabashi, Japan.

SEPTEMBER 15–17, 2003

TCT ABSTRACTS/Poster

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TUESDAY 9/16/03 9:00 –11:00

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Background: Obstructive lesions of the subclavian artery can result in arm claudication and symptoms of subclavian steal. Surgical revascularization has been the preferred method for treating these lesions. Our purpose was to evaluate the safety and efficacy of endovascular stenting for treating 165 obstructive lesions of subclavian artery. Methods: We performed 165 endoluminal stenting procedures in 165 patients (114 men; age, 59 ⫾ 12 years). All procedures were performed with Palmaz stents (105 cases) and Wall stents (60 cases), and 105 cases (63.6%) used the transradial approach. Indications for stenting were arm claudication in 132 cases, subclavian steal syndrome in 23 cases, and myocardial ischemia secondary to compromised flow through the internal mammary graft in 10 cases. Results: Procedural success (defined as abolition of the pressure gradient across the aorta and subclavian artery and a residual diameter stenosis ⬍20% without major complications [acute stent thrombosis, myocardial infarction, embolization, emergency surgery, or death]) was achieved in all 165 patients. All patients had symptomatic relief acutely. No patients had any major complications. Baseline diameter stenosis was reduced from 100% to 15.2 ⫾ 8.5%, and the mean systolic pressure difference between the upper extremities was 44.2 ⫾ 14.5 mm Hg to 1.3 ⫾ 2.2 mm Hg (p ⬍0.01). In 149 of 165 patients, we performed follow-up (at 6 to 12 months) angiography and no restenosis was found. Conclusion: Endoluminal stenting of the subclavian artery is safe and effective with high technical success and excellent hemodynamic results. There were no cerebral or distal embolizations.

TCT-364 Influence of Diabetes on Long-Term Outcome After Infrapopliteal Percutaneous Peripheral Intervention. R.A. Corpus, J.A. House, S.B. Laster, W.C. Daniels, S.P. Marso. Mid America Heart Institute. Kansas City, Missouri, USA.

P O S T E R A B S T R A C T S

Background: Lower extremity peripheral arterial disease, typically involving the infrapopliteal vessels, is a significant cause of morbidity in patients with diabetes. As such, perceptions on prohibitively high peri- and postprocedural event rates in diabetes may influence therapeutic strategies. The purpose of this study was to analyze the effect of diabetes on long-term outcomes after infrapopliteal percutaneous peripheral intervention (PPI) in patients with and without diabetes. Methods: From 1980 to 2001, 409 patients (with diabetes, 158; without diabetes, 251) underwent infrapopliteal PPI for palliation of intermittent claudication (IC; n ⫽ 130) or critical limb ischemia (n ⫽ 279). We assessed long-term outcomes in major adverse peripheral vascular events (MAPVE; amputation, repeat PPI, or lower extremity bypass surgery) and mortality.

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(Exhibit Hall B on the Lower Level)

Results: Compared with patients without diabetes undergoing PPI for IC, those with diabetes had more prior PPIs (p ⫽ 0.02); all other baseline and angiographic parameters were similar. Compared with patients without diabetes undergoing PPI for critical limb ischemia, those with diabetes were older (p ⫽ 0.003) and had a longer length of hospital stay (p ⫽ 0.01). No significant differences in long-term MAPVE existed between patients with and without diabetes undergoing PPI for IC. Compared with those without diabetes undergoing PPI for critical limb ischemia, a trend toward higher MAPVE in diabetes was observed. At 4 years, compared with those without diabetes, mortality rates were significantly higher in patients with diabetes undergoing PPI for IC (55% vs 22%, p ⬍0.001) and PPI for critical limb ischemia (61% vs 46%, p ⫽ 0.01). Conclusion: These data suggest that diabetic status alone should not preclude consideration for PPI in diabetes with IC but may be an important determinant of long-term recurrent MAPVE in diabetes with critical limb ischemia. Cumulative mortality rates were significantly worse in patients with diabetes compared with those without diabetes, suggesting a need for aggressive therapeutic strategies directed at cardiovascular comorbidities.

TCT-365 Renal Artery Stenting to Preserve Renal Function. K. Singh1, J.A. Rodriguez2, C. Wood1, V. Ramaiah2, R. Ravi2, R. Gowda2, P. Perkowski2, D.M. Olsen2, E.B. Diethrich2. 1Geisinger Medical Center, Danville, Pennsylvania, USA; 2Arizona Heart Institute, Phoenix, Arizona, USA. Background: Currently, renal artery revascularization in the presence of well-controlled hypertension solely to prevent renal loss is not universally accepted. Our purpose was to determine if renal artery stenting favorably affects renal tissue loss in patients with atherosclerotic renal artery stenosis (ARAS). Methods: At the Arizona Heart Institute, we reviewed all patients who underwent renal artery stenting between January 1993 and June 2000 for bilateral renal arterial stenosis or stenosis of an artery to a single functioning kidney. In addition, pooled analysis of all available studies in the literature was performed to determine the natural history of untreated ARAS. Results: A total of 60 patients underwent percutaneous intervention to 98 arteries; 38 underwent bilateral stenting, 12 had a single functioning kidney, and 10 underwent stenting of a single renal artery in the presence of bilateral stenoses. Mean follow-up duration was 43 months (range, 1 to 108 months). In all, 1 attempted revascularization was unsuccessful, and 1 patient progressed to dialysis and died directly because of the procedure. No other patient progressed to end-stage renal disease requiring dialysis during follow-up. Primary patency rate was 90% and secondary patency rate was 97%. Serum creatinine did not change significantly during follow-up compared with baseline. Pooled analysis from the literature showed an occlusion rate of 20% per year for ⬎75% ARAS and an expected dialysis rate of 6.5% (2% per year) for a population similar to ours Conclusion: Kaplan-Meier curves for both primary and secondary patency rates in our patients showed a statistically significant difference compared with the untreated group. Although not statistically significant, there was a trend toward reduced need for dialysis (1.6% vs 6.5%). The natural history of ARAS progressing to occlusion is favorably altered by renal arterial stenting. If confirmed in a larger number of patients, this would be clinically more relevant than the treatment of renovascular hypertension by renal arterial stenting.

TCT-366 Peak Systolic Velocity on Duplex Renal Scan: A More Reliable Predictor of Angiographically Significant Renal Artery Stenosis.

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SEPTEMBER 15–17, 2003

TCT ABSTRACTS/Poster

TUESDAY 9/16/03 9:00 –11:00

AM

and 2:00 – 4:00

A. Khan, N. Patel, S. Naushad, E. Qureshi, N. Cavros, S. Janzer, J. Martin, J. Shuck. Lankenau Hospital and Research Center, Bryn Mawr, Pennsylvania, USA. Background: Peak systolic velocity of ⬎210 cm/m2 and the ratio of peak velocities between renal arteries and aorta (RAR) ⱖ3.5 are used for the diagnosis of significant renal artery stenosis (RAS). However, data on the correlation between duplex criteria and their association with angiographically significant RAS are limited. Methods: We evaluated 67 renal arteries in 34 patients (mean age, 69 ⫾ 8 years; 46% women) who had both duplex scanning and renal angiography done for the diagnosis of RAS. A vascular specialist, blinded to the results of the angiography, calculated peak systolic velocity, RAR, renal size, and peak diastolic velocity for each patient. An interventional cardiologist scored renal angiogram results by the percent degree of stenosis. Pearson correlation coefficient and ␹2 analysis defined the relation between duplex parameters and angiography. Receiver operating characteristic curves were drawn to determine the PAS and RAR value that best corresponded with ⬎60% RAS on angiography. Results: Baseline clinical demographics were similar among the cohort. Significant correlation exists between duplex criteria of RAR (r ⫽ 0.64, p ⬍0.001) and peak systolic velocity (r ⫽ 0.69, p ⬍0.001) and angiographically ⬎60% RAS, whereas, the kidney size (OR, 0.34) and peak diastolic velocity (OR, 0.52) were unrelated (p ⫽ NS). There is also strong agreement between RAR and peak systolic velocity (␬, 0.832; p ⬍0.0001) in diagnosing RAS. However, in a multivariate model, peak systolic velocity superceded RAR and peak diastolic velocity in predicting angiographically significant RAS (␹2, 65.12; p ⬍0.001). By receiver operating characteristic curve analysis, a peak systolic velocity of 230 cm/m2 (92 ⫾ 6%) and RAR of 4.0 (89 ⫾ 7%) correlated best with ⬎60% RAS by angiography (p ⬍0.001). Conclusion: Peak systolic velocity by renal duplex scan is a better predictor of angiographically ⬎60% renal artery stenosis. According to our study, the currently used values of peak systolic velocity and RAR overestimate the amount of angiographically significant RAS. Further studies with larger cohorts are warranted to appropriately define the duplex criteria.

TCT-367 Long-Term Outcome of Superficial Femoral Artery Stenting Using Nitinol Stents Compared with Stainless Steel Stents: A Multicenter Study. B. Hayerizadeh1, T. Zeller3, H. Krankenberg2, D. Scheinert1,4, A. Rastan2, S. Geier1, S. Braunlich1,4, K. Wegscheider5, G. Biamino1. 1University of Leipzig Heart Center, Leipzig, Leipzig, Germany; 2Center for Cardiology, Angiology and Vascular Interventions, Hamburg, Germany; 3Heart Center Bad Krozingen, Bad Krozingen, Germany; 4Universita¨tklinium Erlangen, Erlangen, Germany; 5Department for Statistics and Econometrics, University of Hamburg, Hamburg, Germany. Background: Data from 4 high-volume centers in Germany were retrospectively evaluated to determine the long-term value of stenting long superficial femoral artery (SFA) lesions using nitinol stents. Methods: Among consecutive SFA stenting procedures in our centers during 1999 and 2000, 163 SFA stenting procedures using the self-expanding nitinol stent (SMART stent, Cordis; group S) were compared with 166 implantation procedures using self-expandable stainless steel stent (WALLSTENT, Boston Scientific) in the same time window (group W). Patients with in-stent stenting and multiple stent types in the same vessel were excluded. Results: Patients’ mean age was 68.5 ⫾ 10.1 years, and 32% were women. There were no statistically significant age or sex differences between the 2 groups. Patients with diabetes comprised 21% of the S

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(Exhibit Hall B on the Lower Level)

group compared with 40% in the W group (p ⫽ 0.001). Clinical symptoms based on Rutherford criteria for the S group and W group were: II, 19% versus 11%; III, 73% versus 75%; IV, 5% versus 11%; V, 3% versus 3%, respectively; p ⫽ 0.023. In all, 18% of the S group had previous target lesion angioplasty compared with 23% in the W group (p ⫽ NS). There was no difference between the 2 groups comparing lesion length (S group, 178 ⫾ 110 mm; vs W group, 197 ⫾ 101 mm; p ⫽ NS), percent stenosis (S group, 97.9 ⫾ 4.8%; vs W group, 97.2 ⫾ 9.9%) and number of stents (S group, 1.8 ⫾ 1.0; vs W group, 1.8 ⫾ 1.0). Overall, stented length was longer in the W group (S group, 120 ⫾ 78 mm vs W group, 143 ⫾ 98 mm; p ⫽ 0.04). Mean follow-up period was 16.9 ⫾ 8 months. Using Kaplan-Meier analysis, 1-year primary patency in the S group was significantly higher compared with the W group (S group, 61 ⫾ 5% vs W group, 30 ⫾ 5%; p ⬍0.0001). The 1-year assisted primary patency increased to 75 ⫾ 4% in the S group and 53 ⫾ 5% in the W group (p ⬍0.0001). Secondary patency at 1-year was 79 ⫾ 4% in the S group versus 64 ⫾ 5% in the W group (p ⫽ 0.007). After maximum adjustment using Cox regression model including all possible confounding factors, the difference between the 2 stents in the occurrence of restenosis was even more obvious and SMART nitinol stents showed 76% less probability of restenosis (odds ratio for primary patency, 0.24 [(95% confidence interval, 0.11 to 0.54; p ⫽ 0.001]). Conclusion: Stenting long SFA lesions with nitinol stents is associated with a significantly better outcome compared with self-expandable stainless steel stents. The long-term secondary patency of about 80% using nitinol stents demonstrates that this technology is safe and clinically very effective with a good durability.

TCT-368 Lower Incidence of Renal Artery Stenosis Among African American Patients Undergoing Angiography. M.A. Arida, M.H. Al-Mallah, G.K. Sohal, L.M. Poisson, R. Parasuraman, A.D. Kugelmass, A.B. Greenbaum. Henry Ford Heart and Vascular Institute, Detroit, Michigan, USA. Background: Renovascular hypertension is an important correctable cause of secondary hypertension. Race has not been shown to be an independent predictor of renal artery stenosis (RAS), but previous studies have had low minority representation. Our aim was to determine the prevalence and clinical predictors of RAS among a cohort of patients undergoing coronary angiography with emphasis on the factor of race. Our hypothesis was that RAS is less prevalent in African Americans. Methods: A retrospective analysis 366 of patients who underwent abdominal angiography during coronary catheterization at an urban tertiary care center between January 2001 and March 2003 was performed. Baseline demographics, laboratory values, and angiographic findings were recorded. Comparisons were made between those with and without significant (⬎50%) RAS. Results: The mean age of the 366 patients was 65 ⫾ 11 years; 48% were women; 44% were African Americans; 90% had hypertension; 41% had diabetes; and 63% had hyperlipidemia. Significant RAS was found in 17.5% with high-grade stenosis (⬎75%) in 10.9%. Baseline demographics stratified by the presence of RAS is displayed (Table). The incidence of significant renal artery stenosis (⬎50%) was lower among African American patients compared with whites (12% vs 22%, respectively; p ⫽ 0.035). By logistic regression, the African American race was independently associated with less RAS (odds ratio, 0.51; 95% confidence interval, 0.29 to 0.90). Other demographics associated with significant RAS included, history of hypertension and refractory hypertension, known carotid disease, known peripheral vascular disease, and renal insufficiency (glomerular filtration rate ⬍50 mL/min).

SEPTEMBER 15–17, 2003

TCT ABSTRACTS/Poster

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P O S T E R A B S T R A C T S

TUESDAY 9/16/03 9:00 –11:00

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Demographic

RAS (%)

No RAS (%)

p Value

AA race HTN Refractory HTN Carotid Disease PVD HDL ⬍ 45 GFR ⬍ 50

42 98 21 14 34 68 41

47 88 8 3 14 51 16

0.034 0.011 0.002 ⬍0.001 ⬍0.001 0.017 ⬍0.001

AA ⫽ African Americans; GFR ⫽ glomerular filtration rate; HDL ⫽ high-density lipoprotein; HTN ⫽ hypertension; PVD ⫽ peripheral vascular disease; RAS ⫽ renal artery stenosis. Conclusion: Significant RAS is less common among African Americans undergoing abdominal aortography during cardiac catheterization. Diagnostic yield may be improved by incorporating race into clinical predictors.

Prevalence and Safety of Renal Artery Stenosis Screening in a Selected Population Undergoing Coronary Angiogram. S. Mansour, T. Lefe`vre, Y. Louvard, P. Dumas, O. Tavolaro, C. Loubeyre, A. Kokis, S. Gunasekaran, M. Rao, M.C. Morice. Institut Cardiovasculaire Paris Sud, Massy, France.

A B S T R A C T S

Background: Renal artery stenosis (RAS) is a progressive disease and a potentially correctable problem. It may be a cause of hypertension and can contribute to progressive renal failure. Methods: The aim of this study was to prospectively determine the prevalence of RAS in a selected group of patients with hypertension, flash pulmonary edema, and/or renal insufficiency undergoing coronary angiography. This group was defined as being at higher risk for RAS according to previous studies. During coronary angiography, patients had a systematic selective renal artery catheterization or abdominal aortography to detect renal artery stenosis. Results: Among 1,176 coronary angiography procedures performed between January 2003 and May 2003, 118 patients were screened. In this selected group, 77 of 118 (65.5%) had significant coronary artery disease (CAD) and 24 of 118 (20%) significant RAS (stenosis ⬎50% by quantitative renal angiography). Bilateral significant RAS was observed in 5% of cases; 26.6% had both RAS and CAD and 3.4% had significant RAS without CAD. Patients with RAS were older (71 ⫾ 9 years vs 67 ⫾ 7 years, p ⫽ 0.004), had diabetes mellitus more often (50 vs 35%, p ⫽ 0.004) and higher systolic blood pressure (152 ⫾ 12 mm Hg vs 132 ⫾ 16 mm Hg, p ⫽ 0.005). No complications (including creatinine increase) were observed after the procedure in relation to selective or nonselective renal angiography. Conclusion: Screening for RAS at the time of coronary angiography in patients with hypertension, renal insufficiency, or with flash pulmonary edema does not increase the risk of complication and has a high diagnostic yield (20% prevalence), which is even greater in patients who are older and have diabetes.

TCT-370 Is There a Place for the Silicon-Carbide–Coated Stent Below the Groin? P. Peeters1, M. Bosiers2, J. Verbist1, K. Deloose2. 1 Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium; 2Department of Vascular Surgery, St. Blasius Hospital, Dendermonde, Belgium. Background: Our purpose was to investigate the effectiveness of Silicon-Carbide– coated stents in superficial femoral artery (SFA) lesions (Peiron) and below-the-knee lesions (Lekton). Methods: The Silicon-Carbide coating prevents direct contact between blood or surrounding tissue and allergenic metal ions, resulting

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(Exhibit Hall B on the Lower Level)

in a limited release of nickel and chromium. The passive diffusion barrier seals the bare metal surface, preventing corrosion and allergic reactions. Furthermore, it reduces the deposition of fibrin, platelets, and leukocytes, significantly lowering the risk of early and late restenosis. From June 2001 to April 2002, 91 patients with 100 SFA lesions ⱕ50 mm have been included in the Peiron group of the trial. Inclusion of patients with short BTK lesions and critical limb ischemia in the Lekton group started in September 2002; 50 will be included by March 2003. Results: To date, our series of Peiron implants in short SFA lesions show a 6-month primary patency of 92% (N ⫽ 88). By September 2003, 12-month results of the Peiron series and 6-month patency rates of the Lekton series will be available. Conclusion: The preliminary results of the Silicon-Carbide stents below the groin are promising. The passive coating significantly increases patency rates after stenting and offers a valuable cost-effective alternative for the more expensive active-coated stents.

TCT-371

TCT-369

P O S T E R

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Initial Experience with the LuMend Frontrunner Catheter for Treatment of Chronic Superficial Femoral Artery Occlusions. B. Roukoz1, A.W. Haider1, S. Surabhi1, H. Arjomand1, A. Espinoza1, J.P. Runyon2, J. Young2, J. Lukes2, S. Goldberg1, D. McCormick1. 1 Drexel University College of Medicine, Philadelphia, Pennsylvania, USA; 2Christ Hospital, Cincinnati, Ohio, USA. Background: Chronic total occlusions (CTO) remain the most common reason for referring patients with significant superficial femoral artery (SFA) disease to surgery. Angioplasty results remain unsatisfactory because of failure to cross the lesion in most cases. We report the initial experience with the CTO Frontrunner catheter in the treatment of CTO in SFAs. Methods: We tested the LuMend CTO Frontrunner catheter, a new device with a metallic blunt jaw tip, designed to microdissect the CTO and enable distal placement of conventional guidewire to facilitate the angioplasty/stenting procedure. A total of 16 chronic (⬎6 months) SFA lesions were treated in 15 patients (11 men and 4 women), with a mean age of 67 years. All patients had debilitating claudication. The average occlusion length was 11 cm (range, 6 to 18 cm). After recanalization of the lesions, guidewires were placed, and angioplasty and stenting were performed. All patients received aspirin and clopidogrel.

Results: Overall, 15 lesions were crossed successfully with the Frontrunner catheter (94% success). There was no perforation. There was 1 case of short subintimal dissection that resolved after stenting. Distal guidewire placement was successful in all crossed lesions. The mean fluoroscopic time for crossing the lesion was 4.2 minutes. Angioplasty was performed in all patients, and 19 stents were placed with excellent results (minimal lumen diameter increased from 0 to 4.2 mm). Over a follow-up period of 2 to 8 months, all patients were asymptomatic. In 2 patients with skin ulcers, healing of the ulcers was observed. Conclusion: The use of blunt microdissection with the Frontrunner catheter to recanalize chronic occlusions in SFAs appears safe and effective. Larger trials are needed to further evaluate the use of this device in these complex lesions.

SEPTEMBER 15–17, 2003

TCT ABSTRACTS/Poster

TUESDAY 9/16/03 9:00 –11:00

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TCT-372 Optical Coherence Reflectometry with Radiofrequency Energy: A New Treatment for Total Occlusions of Peripheral Arteries. R.R. Heuser, A.K. Reese, K.L. Waters. Phoenix Heart Center at St. Joseph’s Hospital and Medical Center, Phoenix, Arizona, USA.

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the vessels were Trial of Angioplasty and Stents in Canada type B1, B2, or C. Results: Technical success (⬍50% residual) was achieved in 64 of 64 limbs (100%). There were no serious device-related adverse events. For 9 months, follow-up evaluation was performed on 47 limbs, with average follow-up of 11 months for all limbs. Primary patency (target lesion revascularization) and average lesion length for all limbs follow (Table).

Background: Chronic total occlusion (CTO) of the peripheral arteries continues to pose a therapeutic dilemma. Although success in opening CTOs is high (iliac artery, 83%; femoral artery, 90%), dissections occur in up to 6% of cases and require stent placement. Methods: To limit complications associated with CTO treatment, we used the Safe-Steer guidewire system (Intraluminal Therapeutics, Carlsbad, CA), which incorporates optical coherence reflectometry to determine tissue types. A total of 9 patients (10 limbs) were treated using the SafeCross 0.35-inch guidewire and angioplasty with or without stenting. Results: Please see Table.

Primary Patency (All) Primary Patency (PTA) Primary Patency (RE)

Baseline Characteristics & Immediate Results on Patients who Underwent Angioplasty of SFA and Popliteal

Avg ⫽ average; PTA ⫽ percutaneous transluminal angioplasty; RE ⫽ remote endarterectomy; SFA ⫽ superficial femoral artery.

Age/ Target Gender Vessel 76/F 69/M 74/M 74/M 71/M 62/M 76/M 77/M 76/F 76/F

L SFA L SFA L SFA R SFA R SFA R SFA R Popl L SFA R SFA L SFA

Occlusion Age

Occlusion Length

12 m 5m 144 m 144 m 12 m 24 m 36 m 1.5 m 36 m 1.25 m 41.6 m

30 cm 8 cm 50 cm 50 cm 13 cm 21 cm 4 cm 10 cm 20.5 cm 30 cm 23.6 cm

ABI RS

FT

Pre

Post

20% 20% 20% 20% 20% 40% 0 20% 100% 0%

14 min 11 min 14 min 31 min 9 min 29 min 6 min 4 min 30 min 6.5 min 15.5 min

0.46 0.38 0.54 0.38 0.72 0.64 0.65 0.73 0.41 0.45 0.54

1.0 0.68 0.75 0.78 1.0 0.71 0.75 0.72 0.55 0.94 0.86

ABI ⫽ ankle-brachial index; FT ⫽ fluoroscopy time; L ⫽ left; Popl ⫽ popliteal; pre ⫽ before procedure; post ⫽ after procedure; R ⫽ right; RS ⫽ residual stenosis; SFA ⫽ superficial femoral artery. Conclusion: All CTOs were crossed successfully, and there were no dissections or perforations. At 30-day follow-up, all patients had improvement or resolution of claudication.

TCT-373 A Prospective, Nonrandomized Evaluation of the Vascular Architects aSpire Covered Stent for the Treatment of Peripheral Arterial Occlusive Disease. P.J. Schubart1,2. 1O’Connor Hospital, San Jose, California, USA; 2Stanford University, Palo Alto, California, USA. Background: The purpose of this study was to evaluate the safety and efficacy of using the aSpire polytetrafluoroethylene-covered nitinol stent for long-segment iliac and superficial femoral peripheral arterial occlusive disease. Balloon angioplasty and stenting has been shown to be effective in treating common iliac lesions but less effective in treating lesions located in the superficial femoral artery (SFA), where 1-year patency rates range from 75% to 85% in short lesions (3 to 4 cm) down to 22% in the long lesions of 16 cm. Methods: A total of 59 patients (64 limbs) with disabling claudication were enrolled at 10 institutions (9 US, 1 Europe). In these patients, 32 vessels were completely occluded, and 32 vessels were stenotic. All vessels were pretreated with either percutaneous transluminal angioplasty (40) or remote endarterectomy (24). Altogether, 36 SFA and 28 iliac arteries, common and external, were treated; average lesion length was 9.3 cm ⫾ 10.4 cm; and 48 (75%) of

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All Lesions SFA

Iliac SFA Avg. Avg. Length Length

Iliac

86%

83%

90%

All Limbs

13.0 cm

4.5 cm

87%

79%

90%

PTA Only

4.4 cm

4.1 cm

83%

88% 75% (external RE Only iliac)

23.3 cm

5.6 cm

Conclusion: Midterm study results demonstrate the safety and promising efficacy of aSpire in the treatment of complex and long stenoses and occlusions in the SFA and iliac artery.

TCT-374 Economic Analysis of the Trellis Catheter: A Combination Mechanical and Pharmacologic Thrombectomy Catheter. D.E. Hilleman, K.A. Packard. Creighton University Cardiac Center, Omaha, Nebraska, USA. Background: The Trellis catheter is a new combined mechanical and pharmacologic thrombectomy catheter used in the management of peripheral arterial occlusions (PAO) and deep vein thrombosis (DVT). Traditional catheter-directed thrombolysis (CDT) requires the use of substantial doses of thrombolytic agents with potential risk of major hemorrhage. The objective of this study was to compare short-term outcomes (lysis rates, bleeding) and cost of the Trellis catheter with CDT in patients with PAO or DVT. Methods: Data on the short-term outcomes of the Trellis catheter were derived from the initial experience in 26 patients with PAO and 11 patients with DVT. Data on CDT were derived from a meta-analysis of published reports with tissue plasminogen activator (tPA). A total of 10 studies with tPA in PAO (n ⫽ 1,450) and 4 studies with tPA in DVT (n ⫽ 118) were identified. Pooled results were weighted by sample size of each study. Outcomes included lysis success rates and bleeding (major hemorrhage and intracranial hemorrhage rates). Costs, which included the thrombolytic agent, angiography suite time, bleeding, and time in the intensive care unit, were compared between Trellis catheter and CDT. Results: Thrombolytic doses were significantly less with the Trellis catheter (tPA 10 mg) compared with CDT (tPA 53 mg). Lysis success was significantly greater with the Trellis catheter compared with CDT in both PAO (96% vs 84%) and DVT (100% vs 89%). Bleeding was significantly less with the Trellis catheter compared with CDT in both PAO and DVT. There were no episodes of major hemorrhage or intracranial hemorrhage with the Trellis catheter. With CDT, major hemorrhage occurred in 11% of PAO and 12% or DVT patients. With CDT, intracranial hemorrhage occurred in 0.4% of PAO and 1.2% of DVT patients. Costs were significantly less for the Trellis catheter than CDT in PAO ($3,216 vs $4,536) and in DVT ($3,010 vs $3,651) because of lower thrombolytic doses, less bleeding, and shorter procedure and intensive care unit time. Conclusion: Preliminary data indicate that Trellis catheter treatment of PAO and DVT is safer and more effective than CDT. In addition, cost of treatment from lower thrombolytic doses and fewer bleeding events is less with the Trellis catheter than with CDT.

SEPTEMBER 15–17, 2003

TCT ABSTRACTS/Poster

159L

P O S T E R A B S T R A C T S