Clinical improvement after extracranial venoplasty in multiple sclerosis.

PURPOSE: This study proposed to prospectively evaluate safety and clinical changes in outpatient endovascular treatment in patients with multiple sclerosis (MS) and chronic cerebrospinal venous insufficiency (CCSVI). MATERIALS AND METHODS: Two hundred fifty-nine patients with MS were followed with the Multiple Sclerosis Impact Scale (MSIS-29) before and for 1 and 6 months after treatment of extracranial internal jugular vein and azygos vein stenoses and occlusions using venous angioplasty, as well as stent placement in 2.5% of patients. Before treatment, the patients were tested with magnetic resonance (MR) venography and flow quantification. RESULTS: We found statistically significant improvements in the MSIS-29 scores (P < .01) at both 1 and 6 months. At 1 and 6 months, 67.9% and 53.6% were improved on the physical scale, respectively, and 53.0% and 44.4% were improved on the psychological scale, respectively. Women showed greater improvement than did men on the physical scale at 6 months (P = .01). Patients with primary progressive MS (PPMS) showed less improvement than did those with relapsing-remitting MS (RRMS) on the psychological scale at 1 month, and venoplasty treatment of more vein sites versus fewer vein sites showed greater improvement on the physical scale at both 1 and 6 months. Fifteen patients (6.3%) reported recurrent symptoms after clinical improvement and were treated again. There was one serious adverse event, a deep venous thrombosis at the catheter insertion site, which resolved with treatment. CONCLUSIONS: Endovascular treatment of CCSVI in patients with MS appears to be a safe procedure resulting in significant clinical improvement.

Results of a Pilot Study on the Safety and Early Efficacy of Novel Polymethyl Methacrylate Microspheres and a Hyaluronic Acid Device for the Treatment of Low Back Pain Caused by Degenerative and Diseased Intervertebral Discs of the Lumbar Spine.

Background Low back pain (LBP) costs the healthcare system billions of dollars each year. Intervertebral disc (IVD) degeneration is a significant cause of LBP, due to structural defects, biomechanical instability, and inflammation. First-line therapy for patients with LBP includes physical therapy, medication, and steroid injections. DiscSealTM was developed to provide patients who are refractory to first-line therapy with a minimally invasive treatment alternative to invasive surgical procedures. The product is a combination of poly-methyl methacrylate (PMMA) microspheres in hyaluronic acid (HA) that is injected under modified discography into the IVD. Methods Two pain specialist centers in Australia recruited eligible participants who were followed up for 180 days post-procedure. The procedure was conducted using a modified discography technique. Low back and leg pain was reported using the Visual Analogue Scale (VAS) while other endpoints included were Oswestry Disability Index (ODI), Clinician and Patient Global Impact of Change, and Patient Rating of Overall Health Status. The general analytical approach for all endpoints was descriptive in nature and 95% confidence intervals of means were estimated. Results The pilot study achieved its primary objective which was an absence of peri-treatment or post-treatment device-related Serious Adverse Events (SAE) during the first 90 days. There were no device-related serious adverse events recorded throughout the study. The mean LBP percentage change from baseline at 90 and 180 days was -27.0% and -42.3% respectively. The mean ODI percentage change from baseline at 90 and 180 days was -22.3 and -14.2% respectively. End of study improvements shows a 67.8% (20.83) increase in Overall Health Status, as well as positive results for Participant and Clinician Global Impact of Change. These results were achieved based on treating one diseased IVD, although 83.3% of patients were diagnosed with multiple diseased IVDs. Conclusions The results from this pilot study showed that DiscSealTM is safe and well-tolerated. Early efficacy shows that DiscSealTM may be a promising treatment option for people suffering from discogenic LBP that have not responded to first-line treatment options. A larger, statistically powered study where all diseased discs are treated should be completed to validate the promising results from this early feasibility study.

Endograft use in the femoral and popliteal arteries.

The results of infra-inguinal intervention for atherosclerotic occlusive disease have not changed dramatically in the last 15 years despite the advent of many different designs of uncovered stents. "Plain old balloon angioplasty" remains the treatment of choice for short lesions (<3 cm) with good morphologic characteristics. Stents have improved suboptimal angioplasty results somewhat, but results in longer lesions >5 cm have remained poor in most series. Although there are no endografts currently approved for arterial use by the FDA, expanded polytetraflouroethylene (ePTFE) covered endoprostheses are available and their use in the femoropopliteal arteries can dramatically improve the results of endovascular treatment for longer lesions and allow one to treat vascular ruptures and aneurysms. In this article, we will review the published results for the use of endografts in the femoropopliteal arteries and describe what we believe to be the current indications for their use.

Long-term patency and clinical outcome of the Viabahn stent-graft for femoropopliteal artery obstructions.

PURPOSE: To assess the long-term patency of the Viabahn stent-graft after placement for the treatment of occlusive disease of the femoropopliteal artery (FPA). MATERIALS AND METHODS: Viabahn stent-grafts were placed into 87 limbs in 76 patients for the treatment of atherosclerotic occlusive disease of the FPA. Mean lesion length was 14.2 cm (range, 2.8-40 cm), with 80 of 87 lesions (92%) at least 7 cm in length. Patients were followed by duplex ultrasound (US), resting ankle brachial index (ABI) measurement, and clinical status at 6 months, 1 year, and yearly thereafter for a maximum of 8.5 years. A systolic velocity ratio greater than 2.0 on duplex US anywhere in the FPA was defined as a loss of primary vessel patency. RESULTS: Primary, primary assisted, and secondary vessel patency rates were 76%, 87%, and 93%, respectively, at 1 year and 55%, 67%, and 79%, respectively, at 4 years. Mean resting ABI improved from 0.70 before the procedure to 0.90 as of the most recent follow-up (P<.001). Mean Rutherford-Becker classification improved from 3.4 before the procedure to 0.68 as of the most recent follow-up (P<.001). Eighty-eight percent of limbs showed a maintained improvement in clinical status. Primary patency was independent of lesion length and type but dependent on device diameter (P=.001). The primary vessel patency rate in devices of at least 7 mm (n=21) was 82% at 4 years. No stent fractures were observed despite the use of multiple overlapping stent-grafts in 36.8% of limbs (n=32). CONCLUSIONS: This study demonstrates durable vessel patency to 4 years for long Transatlantic Inter-Society Consensus class C and D lesions treated with the Viabahn stent-graft. Results were independent of lesion length and type but dependent on device diameter. This study helps confirm the durability and clinical utility of this device in the treatment of FPA occlusive disease.

Long-term results of ePTFE stent-graft versus angioplasty in the femoropopliteal artery: single center experience from a prospective, randomized trial.

PURPOSE: To describe a single-center experience as part of a U.S. multicenter prospective randomized trial of PTA versus percutaneous transluminal angioplasty (PTA)- and ePTFE (expanded polytetrafluoroethylene)-covered endoprosthesis placement for the treatment of superficial femoral artery (SFA) and proximal popliteal artery stenoses and occlusions. MATERIALS AND METHODS: Twenty-eight patients with claudication or ischemia were treated by PTA alone (n = 13) or PTA and endoprosthesis placement (n = 15). Baseline characteristics, including exercise ankle/brachial index (ABI), number of patent runoff vessels, Rutherford-Becker ischemia score, and lesion length, were equivalent. Follow-up included postprocedure, objective, noninvasive vascular evaluation and a clinical status scale for a minimum of 24 months. RESULTS: Technical success was achieved in 15 of 15 patients (100%) in the endoprosthesis group and 12 of 13 patients (92%) in the PTA group. Complications in the endoprosthesis group included clinically significant embolization (n = 1, successfully treated by thrombolysis) and transient thigh pain that required medication in three patients (20%). Clinical improvement was achieved initially in all patients with a significant increase in exercise ABI in both groups (mean increase from baseline was 0.51 with 95% CI: 0.37-0.64 in endoprosthesis patients and 0.39 with 95% CI: 0.31-0.47 in PTA patients; P =.13). At 6-month follow-up with duplex US, 93% of patients (14 of 15) treated with the Hemobahn endoprosthesis (W.L. Gore & Associates, Flagstaff, AZ) remained primarily patent versus 42% of patients (five of 12) treated with PTA alone. At 2 years follow-up, primary patency remained 87% (13 of 15 patients) in the endoprosthesis group versus only 25% (three of 12 patients) in the PTA group (P =.002). Exercise ABI was >0.15 higher than baseline in 93% of patients (14 of 15) treated with endoprosthesis placement versus 54% of patients (seven of 13) treated by PTA alone. Clinical success was maintained in 87% of patients (13 of 15) in the endoprosthesis group versus 46% of patients (six of 13) in the PTA group. CONCLUSION: This single-center experience with placement of the Hemobahn endoprosthesis (W.L. Gore & Associates) in the SFA demonstrated a statistically significant improvement in both patency and clinical outcome compared with PTA alone.

The Nitinol SMART stent vs Wallstent for suboptimal iliac artery angioplasty: CRISP-US trial results.

PURPOSE: The Cordis Randomized Iliac Stent Project-US (CRISP-US) trial evaluated, with an equivalence design, the performance of the shape memory alloy recoverable technology (SMART) nitinol self-expanding stent and the stainless steel Wallstent for treating iliac artery disease after suboptimal percutaneous transluminal angioplasty (PTA). MATERIALS AND METHODS: This multicenter, prospective, randomized trial comprised 203 patients with chronic limb ischemia who received either the SMART stent (n = 102) or the Wallstent (n = 101) after suboptimal PTA. The primary equivalence end point was a composite of 9-month restenosis, 30-day death, and 9-month target vessel revascularization. Functional, clinical, and hemodynamic assessments were made at hospital discharge and at 1, 6, 9, and 12 months. RESULTS: The 9-month composite end point rate was equivalent for the SMART stent and Wallstent (6.9% vs 5.9%), with low rates of restenosis (3.5% vs 2.7%), death (2.0% vs 0.0%), and revascularization (2.0% vs 4.0%) in the two groups. Primary patency at 12 months was 94.7% and 91.1% with the SMART stent and Wallstent, respectively. Functional and hemodynamic improvement was also comparable between the groups. The acute procedural success rate was higher in the SMART stent group (98.2% vs 87.5%; P =.002). The frequency of major adverse events was similar at 1 year (4.9% vs 5.9%). CONCLUSIONS: The performance of the SMART stent was equivalent to that of the Wallstent for treating iliac artery stenosis. The design characteristics of the SMART stent may contribute to greater procedural success and more accurate stent deployment.