Stephan H. Duda

Sirolimus-Eluting Stents for the Treatment of Obstructive Superficial Femoral Artery Disease Six-Month Results

Background—Stent implantation for obstructive femoropopliteal artery disease has been associated with poor long-term outcomes. This study evaluated the effectiveness of shape memory alloy recoverable technology (SMART) nitinol self-expanding stents coated with a polymer impregnated with sirolimus (rapamycin) versus uncoated SMART stents in superficial femoral artery obstructions. Methods and Results—Thirty-six patients were recruited for this double-blind, randomized, prospective trial. All patients had chronic limb ischemia and femoral artery occlusions (57%) or stenoses (average lesion length, 85±57 mm). Patients were eligible for randomization after successful guidewire passage across the lesion. Eighteen patients received sirolimus-eluting SMART stents and 18 patients received uncoated SMART stents. The primary end point of the study was the in-stent mean percent diameter stenosis, as measured by quantitative angiography at 6 months. The in-stent mean percent diameter stenosis was 22.6% in the sirolimus-eluting stent group versus 30.9% in the uncoated stent group (P =0.294). The in-stent mean lumen diameter was significantly larger in the sirolimus-eluting stent group (4.95 mm versus 4.31 mm in the uncoated stent group;P =0.047). No serious adverse events (death or prolonged hospitalization) were reported. Conclusions—The use of sirolimus-eluting SMART stents for superficial femoral artery occlusion is feasible, with a trend toward reducing late loss compared with uncoated stents. The coated stent also proved to be safe and was not associated with any serious adverse events.

Drug-Eluting and Bare Nitinol Stents for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery: Long-Term Results from the SIROCCO Trial

Purpose: To review clinical outcomes of patients with chronic limb ischemia and TASC type C lesions treated with sirolimus-eluting versus bare SMART nitinol self-expanding stents. Methods: Data were obtained from a randomized, multicenter, double-blinded study conducted in 2 phases. All 93 patients had chronic limb ischemia and superficial femoral artery (SFA) occlusions or stenoses (average lesion length 8.3 cm). In total, 47 patients (31 men; mean age 66.3±9.1 years, range 50–84) received the sirolimus-eluting SMART stent and 46 patients (36 men; mean age 65.9 ± 10.8 years, range 38–83) received a bare SMART nitinol stent. Both groups were followed for a mean 24 months. Results: Both the sirolimus-eluting and the bare SMART stents were effective in revascularizing the diseased SFA and in sustaining freedom from restenosis. For both types of stents, improvements in ankle-brachial indices (ABI) and symptoms of claudication were maintained over 24 months (median 24-month ABI 0.96 for the sirolimus group versus 0.87 for the bare stent group, p>0.05). At 24 months, the restenosis rate in the sirolimus group was 22.9% versus 21.1% in the bare stent group (p>0.05). The cumulative in-stent restenosis rates according to duplex ultrasound were 4.7%, 9.0%, 15.6%, and 21.9%, respectively, at 6, 9, 18, and 24 months; the rates did not differ significantly between the treatment groups. The TLR rate for the sirolimus group was 6% and for the bare stent group 13%; the TVR rates were somewhat higher: 13% and 22%, respectively. Mortality rates did not differ significantly between the groups. Conclusion: These data demonstrate that the sirolimus-eluting and the bare SMART stent are effective, safe, and free from restenosis in a majority of patients for up to 24 months. Because the restenosis rate in the bare stent group is unexpectedly low, no significant difference could be found between the sirolimus-eluting and the bare SMART stents.

Sirolimus-Eluting versus Bare Nitinol Stent for Obstructive Superficial Femoral Artery Disease: The SIROCCO II Trial

PURPOSE To investigate further the safety and efficacy of the sirolimus-eluting S. M.A.R.T. Nitinol Self-expanding Stent by comparison with a bare stent in superficial femoral artery (SFA) obstructions. MATERIALS AND METHODS This randomized, double-blind study involved 57 patients (29 in the sirolimus-eluting stent group and 28 in the bare stent group) with chronic limb ischemia and SFA occlusions (66.7%) or stenoses (average lesion length, 81.5 mm +/- 41.2). Stent implantation followed standard interventional techniques and a maximum of two stents could be implanted. The primary endpoint was the in-stent mean lumen diameter at 6 months as determined by quantitative angiography. RESULTS Both stent types were effective in revascularizing the diseased SFA and allowing sustained patency for at least 6 months. There was no statistically significant difference between treatment groups in the in-stent mean lumen diameter at 6 months (4.94 mm +/- 0.69 and 4.76 mm +/- 0.54 mm for sirolimus-eluting and bare stent groups, respectively; P = .31). Although the diameter of the target lesion tended to be larger and percent stenosis tended to be lower with the sirolimus-eluting stent, there were no statistically significant differences between treatments in terms of any of the variables. The mean late loss values were 0.38 mm +/- 0.64 and 0.68 mm +/- 0.97 for the sirolimus-eluting stent group and the bare stent group, respectively (P = .20). The binary restenosis rates, with a cutoff of 50% at 6 months, were zero in the sirolimus-eluting stent group and 7.7% in the bare stent group (P = .49). Clinical outcomes matched angiographic outcomes with improvements in ankle-brachial index and symptoms of claudication. There was no significant difference between treatments in terms of adverse events. CONCLUSION Although there is a trend for greater efficacy in the sirolimus-eluting stent group, there were no statistically significant differences in any of the variables.

Massive pulmonary embolism: percutaneous emergency treatment by pigtail rotation catheter.

OBJECTIVES This study was designed to assess the feasibility, efficacy and safety of mechanical fragmentation of pulmonary emboli using a new rotational pigtail catheter system. BACKGROUND Acute massive pulmonary embolism associated with right ventricular dysfunction is frequently lethal, despite high-dose thrombolytic therapy. Adjunctive catheter fragmentation may prevent a fatal outcome. METHODS In 20 patients (age 58.9+/-10.5 years) with severe hemodynamic impairment, massive pulmonary emboli were fragmented by mechanical action of the rotating pigtail. Fifteen patients received thrombolysis after embolus fragmentation or no thrombolysis at all (noninterference group). RESULTS Prefragmentation pulmonary arterial occlusion was 68.6 +/- 11.3% for both lungs. Pulmonary placement and navigation of the fragmentation catheter was easy and rapid. Fragmentation time was 17+/-8 min. The noninterference group showed a decrease pre- to postfragmentation of shock index from 1.28+/-0.53 to 0.95+/-0.38 (p = 0.011), mean pulmonary artery pressure from 31+/-5.7 to 28+/-7.5 mm Hg (p = 0.02) and a recanalization by fragmentation of 32.9+/-11.8% (mean angiographic score per treated lung from 7.4 to 5.0). Overall mortality was 20%. CONCLUSIONS Fragmentation by pigtail rotation catheter provided for a rapid and safe improvement of the hemodynamic situation and an average recanalization of about one-third of the pulmonary embolic occlusion. The method appears useful especially in high-risk patients threatened by right ventricular failure, to accelerate thrombolysis, and as a minimal-invasive alternative to surgical embolectomy.

A survey of stent designs

Over 100 different stent designs are currently being marketed or are in evaluation for vascular and non-vascular indications. This paper attempts to differentiate stent designs by engineering aspects. A stent design pyramid is presented, which breaks the differentiating aspects into materials, raw material forms, fabrication methods, geometrical features, and additions. The primary distinguishing factor in all groups is balloon-expansion versus self-expandability. Typical examples for each category of the pyramid are shown.

Physical Properties of Endovascular Stents: An Experimental Comparison

PURPOSE Different endovascular stent types (AVE Bridge, AVE Bridge X, Memotherm, Palmaz Large, Palmaz Medium, Palmaz-Schatz Long-Medium, Perflex, S.MA.R.T., Symphony, and Wall-stent) of 4 cm length and 8 mm diameter were subjected to standardized physical tests. MATERIALS AND METHODS The metal mass of each stent was assessed by weighing. The balloon-expandable stents were pneumatically tested for hoop strength. In self-expanding stents, radial resistive force and chronic outward force were determined with use of a loop test. Stent delivery system pushability was assessed in a crossover model. Stent radiopacity was analyzed quantitatively. RESULTS The hoop strength of the balloon-expandable stents ranged from 15.8 N/cm (Perflex) to 28.9 N/cm (AVE Bridge X). The stent weight increased with greater hoop strength (Perflex, 0.046 g/cm vs. AVE Bridge X, 0.061 g(cm). The self-expanding stents had a radial resistive force between 0.39 N/cm (Wallstent) and 1.7 N/cm (Smart). The flexible balloon-expandable stents showed pushability values between 0.13/N (AVE Bridge) and 0.20/N (Perflex). The self-expanding stents had flexibilities between 0.13/N (Memotherm) and 0.24/N (Symphony). Radiopacity assessed with use of a phantom simulating the iliac region ranged from 92 (Palmaz Large) to 115 (AVE Bridge) on a 256-point gray scale (0 = black, 256 = white). CONCLUSIONS There is no stent with ideal physical properties. However, depending on the characteristics of the arterial lesion to be treated, the most appropriate stent can be chosen.

MR imaging in the presence of vascular stents: A systematic assessment of artifacts for various stent orientations, sequence types, and field strengths.

A systematic evaluation of the potential quality of magnetic resonance images recorded in the presence of metallic stents was performed on a low‐field open imager operating at 0.2 T and on a high‐field closed unit operating at 1.0 T. Eight different stent types were examined by two‐dimensional gradient‐echo sequences with echo times of 4 and 10 msec and by a fast spin‐echo technique. In addition, a three‐dimensional gradient‐echo sequence was applied with an echo time of 2.4 msec. A set of sequence and slice parameters was used on both scanners. Thus, artifacts due to susceptibility effects depending on the magnetic field strength could be distinguished from radiofrequency shielding effects in the lumen of the stents (independent of the field strength). Nine different orthogonal orientations of the stent axis and the image (in terms of slice, read, and phase‐encoding direction) were tested, and the artifacts (extension of signal void and visibility of the lumen) were compared. The optimal strategy for visualization of vascular and perivascular regions outside the stents was fast spin‐echo imaging with the stent axis and read direction parallel to the static field. Susceptibility‐induced signal void in gradient‐echo images was minimal using the three‐dimensional approach. Increased transmitter amplitudes above usual values provided clearly improved insight in the lumen using gradient‐echo sequences. J. Magn. Reson. Imaging 2000;12:606–615.

Drug eluting stents-potential applications for peripheral arterial occlusive disease

Many different approaches have been evaluated to prevent restenosis in stents after vascular implantation. Currently, drug-eluting stents are extremely promising in suppressing neointimal hyperplasia. Various animal studies and randomized trials in humans have shown excellent results in terms of safety and efficacy during intermediate-term follow-up. This article will give an overview of experimental and clinical data of the different agents in published and ongoing trials.

Embolization of renal vascular lesions: Clinical experience with microcoils and tracker catheters

After biopsy (n=6) and nephrostomy (n=1) of three native and four transplanted kidneys, gross hematuria, hypertension, and deterioration of function necessitated performance of transarterial embolization. Angiography revealed five arteriovenous fistulas (AVFs), one pseudoaneurysm, and one arteriocaliceal fistula. Superselective catheterization was accomplished using 5 Fr standard diagnostic catheters and 3 Fr coaxial Tracker catheters. Four of five AVFs were embolized successfully by inserting unfibered (2 patients) and fibered (2 patients) platinum coils (diameters 2 mm and 4 mm, respectively). For one AVF, additional injection of butylcyanoacrylate was necessary. The pseudoaneurysm was embolized successfully by such injection, and the arteriocaliceal fistula was occluded using one unfibered 2-mm coil. Embolization stopped the bleeding in all patients. One week after treatment, renal function was improved in 5 patients and remained unaffected in 2. Superselective embolization using Tracker catheters and fibered microcoils is an effective, safe treatment of renal vascular lesions.

Noninvasive procedures for diagnosis of renovascular hypertension in renal transplant recipients : a prospective analysis

The purpose of this study was to clarify the selectivity and specificity of noninvasive procedures for diagnosis of clinically suspected posttransplant renovascular hypertension. We prospectively investigated 25 renal transplant recipients with arterial hypertension and clinically suspected stenosis of the graft artery (8 female and 17 male patients; ages 45±15 years). We performed a captopril test with 25 mg captopril (n=25), renography with technetium-99m diethylene triamine penta-acetic acid (99mTc-DTPA) before and after angiotensin-converting enzyme (ACE) inhibition with determination of glomerular filtration rate (GFR) and effective renal plasma flow (ERPF) (n=23) and color-coded duplex ultrasonography of the transplant kidney vessels (n=24). Renal transplant artery stenosis (RTAS) was excluded by renal arteriography in 20 patients and by operative evaluation or clinical follow-up in 5 patients. We identified 4 patients with RTAS and renovascular hypertension. The noninvasive methods showed the following results (sensitivity/specificity): (1) captopril test: 75%/67%; (2) renography combined with ACE-inhibition: 75%/84%; and (3) color-coded duplex ultrasonography: 100%/75%. We conclude that in patients with clinical evidence of RTAS most noninvasive diagnostic procedures are not sufficiently accurate to exclude the diagnosis. Only color-coded duplex ultrasonography did not fail to detect all patients with RTAS and may act as a screening test. Intraarterial renal angiography remains the most reliable and as-yet indispensable diagnostic test for transplant recipients to rule out RTAS.