Evaluation of safety and efficacy of the S.M.A.R.T.® Flex Vascular Stent System (OPEN study).

OBJECTIVES: The OPEN study evaluated the safety and efficacy of the S.M.A.R.T.® Flex Vascular Stent System in patients with femoropopliteal arterial disease. BACKGROUND: Long-term data on endovascular treatments of femoropopliteal arterial disease are required to establish the repair durability. METHODS: The OPEN study was a multicenter, single-arm, prospective study comparing primary safety and efficacy outcomes to performance goals (PG) developed for bare nitinol stents. Patients with symptoms due to a single, ≤180 mm length, de novo femoropopliteal arterial lesion with >70% stenosis were enrolled and followed for 36 months. Subjects with lesions ≤150 mm served as the initial comparison cohort for the PG (other cohorts were analyzed if the PG was met). RESULTS: 257 subjects with lesions ≤180 mm were enrolled. The mean lesion length was 71 ± 46 mm, and 52.5% had severe claudication. The primary safety endpoint (freedom from all-cause death, index limb amputation, and target lesion revascularization [TLR] through 30 days) was met in 98.8% (96.5%, 99.6%) of subjects in the comparison cohort, meeting the PG (88.0%). The primary efficacy endpoint (comparison cohort vessel patency at 12 months) was 68.4% (61.1%, 74.8%), where the lower limit of the 95% confidence interval did not meet the 66.0% PG. Freedom from TLR in the per-protocol cohort at 12-, 24-, 36-month was 84.7%, 74.6%, and 72.8%, respectively. The 24-month stent fracture rate was 4.3%, with no new fractures identified at 36 months. CONCLUSION: The results show promising long-term safety and effectiveness for the S.M.A.R.T.® Flex Vascular Stent System in patients with femoropopliteal arterial disease.

Five-year results of the INSPIRATION study for the INCRAFT low-profile endovascular aortic stent graft system.

OBJECTIVE: We present the 5-year results of a prospective regulatory study of the INCRAFT device, a low-profile endovascular stent graft system for repair of abdominal aortic aneurysms. METHODS: This was an open-label prospective nonrandomized single-arm study enrolling in centers in the United States and Japan. The primary effectiveness outcome was successful aneurysm treatment and the primary safety outcome was the incidence of major adverse events at 30 days after the procedure. Major long-term outcomes were mortality, reintervention, adverse limb outcomes, and suprarenal stent fracture. RESULTS: One hundred and ninety patients (mean age, 73.8 ± 7.6 years; 90% male; 69% white and 30% Asian) were enrolled from 32 centers throughout the United States and Japan. Minimal access vessel size was less than 7 mm on both sides in 43.9% of the study cohort. Thirty-day major adverse events occurred in 3.2% of patients (6/190). Periprocedural technical success was 94.1% (176/187). Successful aneurysm treatment was 100% at 30 days and 87.9% at 1 year. Two patients required open conversion for thromboembolic complications, 3 developed new type I or III endoleaks, and 7 experienced graft or limb occlusion. Freedom from graft occlusion was 96 ± 2% at 1 year and 94 ± 2% at 5 years. Freedom from stent fracture was 97 ± 1% at 1 year and 87 ± 3% at 5 years. Freedom from aneurysm-related mortality was 99 ± 1% at 1 and 5 years. CONCLUSIONS: This study demonstrates good efficacy and safety and a very low rate of aneurysm related deaths with the INCRAFT device in a population with a high proportion of challenging anatomy.

Utility of a Power Aspiration-Based Extraction Technique as an Initial and Secondary Approach in the Treatment of Peripheral Arterial Thromboembolism: Results of the Multicenter PRISM Trial.

PURPOSE: To investigate the safety and initial efficacy of XTRACT, a power aspiration-based extraction technique for treatment of peripheral arterial thromboembolism with the use of the Penumbra/Indigo system. MATERIALS AND METHODS: A total of 79 patients were enrolled: 39 (49.4%) underwent XTRACT as the initial therapy and 40 (50.6%) underwent XTRACT after failed catheter-directed thrombolysis or other mechanical intervention or for removal of distal emboli that occurred during an intervention. Occlusion locations were as follows: 36.7% (n = 29) in the profunda, common, or superficial femoral artery; 35.4% (n = 28) in the popliteal artery; 15.2% (n = 12) in the tibial artery; 7.6% (n = 6) in the peroneal artery; and the remainder in the common iliac (n = 1), external iliac (n = 1), sciatic (n = 1), and brachial (n = 1) arteries. RESULTS: Complete or near-complete revascularization (Thrombolysis In Myocardial Infarction [TIMI] grade 2/3 flow) was achieved in 87.2% of patients (68 of 78) immediately after the XTRACT procedure and before any other intervention. Successful revascularization was achieved in 79.5% of patients (31 of 39) as an initial treatment and in 92.5% (37 of 40) as salvage or secondary therapy. After additional adjunctive endovascular interventions, TIMI grade 2/3 flow was achieved in 96.2% of patients (76 of 79). Complete thrombus removal and restoration of normal flow (TIMI grade 3) was achieved in 77.2% of patients (61 of 79) after all endovascular treatment was completed. No patients required surgical revascularization. No device-related adverse events occurred. CONCLUSIONS: XTRACT was safe and effective for revascularization of acute or subacute peripheral arterial occlusions as a primary therapy or as a secondary therapy after other endovascular techniques had failed.

Cerebral Granulomatous Inflammation Secondary to Hydrophilic Polymer Embolization Following Thrombectomy.

BACKGROUND Given the recent completion of multiple trials demonstrating the benefit of endovascular mechanical thrombectomy for select patients with proximal large artery occlusive ischemic strokes, there has been a large increase in the performance of these procedures. In the context of increased thrombectomy performance, there have also been increased reports of rare occurrences of granulomatous inflammatory response to the hydrophilic polymer which coat many of these interventional devices. CASE REPORT A 59-year-old female presented with a complete occlusion of her right proximal middle cerebral artery (MCA) and imaging showed a large area of penumbra. Cerebral angiogram and mechanical thrombectomy were successfully performed with reversal of clinical symptoms. Eight months following her stroke, she developed progressive recurrence of left-sided neurological deficits. After extensive workup culminating in tissue sampling, she was found to have developed granulomatous inflammation surrounding microscopic embolization of hydrophilic polymer, which is used to coat many interventional devices such as wires and catheters. The patient responded both clinically and radiographically to anti-inflammatory steroid therapy. CONCLUSIONS Recognizing the significant potential morbidity of a large vessel ischemic stroke and the expanded use of endovascular interventions aimed at staving off this disability, there are emerging and at times indolent complications from the use of hydrophilic polymer coated wires and catheters. This rare and potentially under-recognized complication should be considered in the differential for any patient with new neurological findings following cerebral intervention, especially given the consideration that this appears to a treatable complication.

Preclinical evaluation of the InCraft" aortic endograft in a sheep model.

Animal models remain the gold standard for the preclinical evaluation of tissue response, sealing and integrity of aortic endografts. Preclinical testing of the InCraft® device was performed to evaluate these attributes. Through the femoral arteries of eight male crossbred sheep, 22 mm diameter InCraft® Aortic Bifurcate devices were deployed in the abdominal aortas, and shortened 13 mm diameter iliac limbs were deployed in the right iliac arteries. Vessels were excised for radiographic and histopathologic assessment at six months. There were no instances of graft thrombosis, type I endoleak or endograft migration. No fractures of the stents or fixation barbs were observed. There were minimal inflammatory changes on histology, characterized by histiocytes and multinucleated giant cells located along the fabric. The InCraft® device has favorable tissue compatibility and functions well in a sheep model, maintaining patency and sealing without migration, stent fracture or abnormal histologic changes.

Current hospital costs and medicare reimbursement for endovascular abdominal aortic aneurysm repair.

OBJECTIVE: The purpose of this study was to analyze the current inpatient hospital cost and Medicare reimbursement of endovascular abdominal aortic aneurysm repair (EVAR) at different hospitals. METHODS: The cost of EVAR from October 2000 to October 2001 with two commercially available endografts (Ancure, Guidant Endovascular Solutions, Menlo Park, Calif; and AneuRx, Medtronic AVE, Santa Rosa, Calif) was retrospectively analyzed at seven hospitals. Three university (n = 111) and four community hospitals (n = 110) from different regions of the country participated in the survey. Consecutive cases with complete financial records were included. Hospital finance departments provided their best estimates of hospital costs, including overhead for operating room, endograft, medical supply, bed, radiology, laboratory, and pharmacy services and reimbursement on the basis of hospital-specific Diagnostic Related Groups (DRG) 110 or 111. Detailed hospital charges and International Clinical Diagnosis codes also were reviewed from Universal Billing-92 forms submitted to Medicare. An additional cost analysis was performed by the authors to validate the estimates of the hospital financial departments. Outliers of more than three standard deviations from the mean were excluded. RESULTS: The mean total hospital cost was $22,999, and mean reimbursement, weighted by case mix, was $20,837, resulting in a net loss of $2162. The majority of EVAR cost was from the device (57%) and other medical supplies (16%). EVAR was reimbursed on the basis of DRG 110 in 78% of cases and of DRG 111 in 22%. Reimbursement varied widely by hospital and location (mean, $20,837; range, $14,818 to $35,343; standard deviation, $5450). With the exclusion of one hospital where reimbursement was not based on the DRG, cases reimbursed with DRG 110 resulted in an average loss of $2200, while the average loss was $9198 with DRG 111. The mean net loss for hospitals reimbursed with the DRG system was $3898. CONCLUSION: EVAR reimbursement is presently inadequate to cover hospital expenses. Substantial financial losses occurred at four of the participating centers. University hospitals fared surprisingly better because of higher reimbursement.