Vincent L. Oliva

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.

Günther Tulip Retrievable Vena Cava Filter: Results from the Registry of the Canadian Interventional Radiology Association

PURPOSE To report data collected by the Canadian Registry of the Günther Tulip Retrievable Filter (GTF). MATERIALS AND METHODS Between February 1998 and December 2000, 90 patients at eight hospitals underwent implantation of 91 GTFs. There were 45 male patients and 45 female patients, age 17-88 years, with a mean age of 49 years. Indications for filter placement were pulmonary embolism (PE) or deep vein thrombosis (DVT) with a contraindication to anticoagulation in 83 patients, prophylaxis after massive PE in one, prophylaxis for proximal free-floating thrombus in one, and prophylaxis with no DVT or PE in six patients (major trauma, n = 4; high preoperative risk, n = 2). GTF retrieval was attempted in selected patients from a right internal jugular vein approach. RESULTS One GTF was inadvertently placed in the right iliac vein and could not be retrieved. There were no other major placement complications. GTF retrieval was attempted in 52 patients (53 GTFs); 52 GTFs were successfully retrieved from 51 patients. Implantation times were 2-25 days (mean, 9 d). Of these 51 patients, 37 underwent follow-up for 5-420 days (mean, 103 d) after filter retrieval. Four patients (8% of retrieved GTFs) required reinsertion of a permanent filter 17-167 days (mean, 78 d) after GTF retrieval as a result of bleeding from anticoagulation (n = 2) or because the patient required further surgery (n = 2). One other patient had recurrent DVT 230 days after retrieval; no PE or other complication was documented in the retrieval group. GTFs were not retrieved from 39 patients for various reasons. Of these 39 patients, 25 underwent follow-up 7-420 days (mean, 85 d) after filter placement. Two patients developed filter occlusion (5%); no other complications were documented. CONCLUSION The GTF has a broad range of utility: it can be used as a permanent filter or retrieved after implantation periods of 15 days and possibly longer. However, indications for retrieval require further study, as does the maximum implantation time.

The 6-F nitinol TrapEase inferior vena cava filter: Results of a prospective multicenter trial

PURPOSE The authors report the first results of a new 6-F symmetrically designed permanent nitinol inferior vena cava (IVC) filter, the Cordis TrapEase, evaluated in a multicenter prospective study with 6-months of follow-up. MATERIALS AND METHODS A total of 65 patients (29 men, 36 women) who ranged in age from 37 to 96 years (mean age, 68 years) and who were at high risk of pulmonary embolism (PE) were enrolled in 12 centers in Europe and Canada. The study was approved by the institutional review boards at all centers. Study objectives were to evaluate filter effectiveness, filter stability, and caval occlusion. Indications for filter placement were deep vein thrombosis with recurrent thromboembolism and/or free-floating thrombus with contraindication to anticoagulation in 37 patients, and complications in achieving adequate anticoagulation in 28 patients. Follow-up included clinical examination, plain film, Doppler ultrasound, CT scan, and nuclear medicine. RESULTS The analysis of the data revealed a technical success of 95.4% (three filter-system related implantations not at the intended site, no events of filter tilting) and a clinical success of 100% at 6 months (no cases of symptomatic PE), the study primary endpoint. There were no cases (0%) of filter migration, insertion site thrombosis, filter fracture, or vessel wall perforation. During the study period, there were two cases of filter thrombosis: one case of early symptomatic thrombosis that was successfully treated in the hospital, and one case of nonsymptomatic filter thrombosis detected at 1-month follow-up, with spontaneous recanalization at 3 months. In the latter patient, some residual thrombus was still detected at 6 months. Of the study population of 65 patients, there were 23 deaths. These deaths were not related to the device or the implantation procedure but to the underlying disease process. CONCLUSION This study demonstrates the new nitinol permanent IVC filter to be a safe and an effective device, with a low overall complication rate, for use in patients with thromboembolic disease at high risk of PE.

The Jonas Study: Evaluation of the Retrievability of the Cordis OptEase Inferior Vena Cava Filter

PURPOSE To evaluate the success, safety, and efficacy of the retrieval of the OptEase Permanent/Retrievable Vena Cava Filter (Cordis, Warren, NJ), when implanted for temporary protection against venous thromboembolism. MATERIALS AND METHODS This prospective, multicenter, non-randomized study enrolled 27 patients who needed temporary protection against pulmonary embolism in whom the intent at the time of filter insertion was retrieval of the OptEase filter. Patients presented with deep venous thrombosis (n = 17), pulmonary embolism (PE) (n = 6), and high risk for PE without thromboembolic disease (n = 4). Assessments included duplex sonography of the access site performed within 24 hours of device implantation and retrieval. All patients underwent cavography before and after filter placement and filter retrieval. Contrast-enhanced computed tomography (CT) of the abdomen and clinical follow-up was performed at 1 month after device retrieval. RESULTS Of the 27 enrolled patients, 21 patients (77.8%) met the criteria for retrieval and all 21 patients (100%) had filters successfully retrieved with no associated adverse events. Retrieval was not attempted in six patients as a result of ongoing contraindication to anticoagulation (n = 3), large trapped thrombi within the filter (n = 2), and poor patient prognosis (n = 1). Time to retrieval ranged from 5 to 14 days with a mean implantation time of 11.1 days +/- 1.82. No symptomatic pulmonary embolism, vena cava wall injury, vena cava stenosis, significant bleeding, filter fracture, or filter migration was observed. Nineteen of the 21 patients (90.5%) were followed for 1-month post-retrieval with no device-related adverse events or symptomatic PE. Caval patency was documented in 18 of these 19 patients with CT. Two patients were lost to follow-up, and one patient refused to undergo CT examination. CONCLUSION The OptEase permanent/retrievable vena cava filter can be safely and successfully retrieved up to 14 days in patients who no longer require inferior vena cava filter protection against pulmonary embolism.

Embolization of Pulmonary Arteriovenous Malformations with Amplatzer Vascular Plugs: Safety and Midterm Effectiveness

PURPOSE To evaluate the safety and effectiveness of Amplatzer vascular plugs (AVPs) for percutaneous closure of arteries feeding pulmonary arteriovenous malformations (PAVMs). MATERIALS AND METHODS Over a 45-month period, 24 consecutive patients with at least one PAVM treated with an AVP were selected from a database on patients with a PAVM who received embolotherapy. Immediate technical success was defined as the complete absence of flow through the PAVM after embolization without the need for additional embolization material. Success on follow-up imaging was defined as a reduction in size of at least 70% of the aneurysm or draining vein on follow-up computed tomography or the absence of flow through the PAVM on a subsequent pulmonary angiogram. RESULTS Thirty-seven AVPs were used to close 36 feeding arteries in 35 PAVMs in seven male and 17 female patients aged 11-86 years (mean age, 50 y). Technical success was achieved in 35 feeding arteries (97%). One feeding artery required two AVPs for closure. There were no immediate procedure-related complications. At a mean clinical follow-up of 322 days (range, 1-1,126 d), all patients were alive without new PAVM-related complications. Imaging follow-up was available for 29 embolized vessels (81%) with a mean follow-up of 418 days (range, 40-937 d), and recanalization occurred in two treated vessels (7%). CONCLUSIONS AVPs are safe and effective for closure of PAVMs feeding vessels that can be reached with a guiding catheter, with an acceptable rate of recanalization.

Pain and Quality of Life Assessment after Endovascular Versus Open Repair of Abdominal Aortic Aneurysms in Patients at Low Risk

PURPOSE To compare functional autonomy, quality of life (QOL), and pain control after endovascular and open repair (OR) of abdominal aortic aneurysms. MATERIALS AND METHODS Forty patients with a low surgical risk profile and anatomic compatibility for stent-graft therapy were randomized to receive OR or endovascular aneurysm repair (EVAR). Technical and clinical success as well as mortality were assessed in both groups and compared by Kaplan-Meier analysis. Functional autonomy and QOL were assessed by Karnofsky score and Short Form 36 (SF-36) questionnaire. Pain control was assessed by a numeric rating scale and Brief Pain Inventory questionnaire. QOL outcomes by means of the SF-36 and pain questionnaires were compared with use of mixed-effects models for repeated-measures analysis. RESULTS All procedures were technically successful in both groups. Three late clinical failures requiring surgical conversion or repeated intervention were observed in the EVAR group and one was observed in the OR group. There was no significant difference between groups in terms of functional autonomy or QOL. No difference in pain level was evident during the early postoperative period, whereas the pain level was lower in the OR group after 1 month. Opioid analgesic drug consumption was significantly greater in the OR group during the postoperative period. Mean hospitalization duration was shorter in the EVAR group than in the OR group (4.5 days +/- 2.4 vs 11.5 days +/- 8.1; P= .001). CONCLUSION EVAR has no advantage over OR in patients at low risk in terms of functional autonomy, QOL, and pain control. However, EVAR was associated with shorter hospitalization durations compared with OR.

Recovery G2 Inferior Vena Cava Filter: Technical Success and Safety of Retrieval

PURPOSE To assess the safety and technical success of the retrieval of the Recovery G2 filter when implanted for temporary protection against pulmonary embolism. MATERIALS AND METHODS The Recovery G2 inferior vena cava (IVC) filter was placed in 120 consecutive patients between September 2005 and September 2006 in a single center. Patients had deep venous thrombosis (DVT) (n = 63), pulmonary embolism and DVT (n = 55), and high risk for pulmonary embolism without recent thromboembolic disease (n = 2). Indications for filter placement included contraindication to anticoagulation (n = 106), failure of anticoagulation (n = 11), and prophylaxis in addition to anticoagulation (n = 3). In patients eligible for filter removal, the authors measured the mean implantation time, filter retrieval success rate, and retrieval procedure time. In addition, they assessed filter tilting, migration, caval penetration, thrombus within the filter, fracture, and caval injury or stenosis. RESULTS In the 51 patients who met the criteria for filter removal, filter tilting (>15 degrees ) was seen in six patients (12%), small thrombi were seen in filters of 15 patients (29%), presumed caval penetration was seen in nine patients (18%), and caudal filter migration was seen in two patients (3.9%). There were no fractures or cephalic migrations. Removal attempts were successful in all 51 patients (100%). The mean implantation time was 53.4 days (range, 7-242 days), and the retrieval procedure time averaged 16.8 minutes (range, 5-60 minutes). CONCLUSIONS Retrieval of the Recovery G2 filter is safe and can be performed successfully in patients who no longer need IVC filtration.

PTFE-covered self-expanding nitinol stents for the treatment of severe iliac and femoral artery stenoses and occlusions: final results from a prospective study.

Purpose: To evaluate the technical performance, safety, and 1-year clinical efficacy of polytetrafluoroethylene (PTFE)-covered nitinol stents in the treatment of atherosclerotic iliac and superficial femoral artery (SFA) disease. Methods: The multicenter, prospective, nonrandomized COVENT study involved 98 patients (70 men; mean age 64±10 years) who received PTFE-covered nitinol stents in 107 arteries (60 iliac and 47 SFAs) after predilation. The average lesion length was 50 mm in the SFA and 45 mm in the iliac arteries. Postdilation was performed when necessary. Duplex ultrasound and ankle-brachial index (ABI) were performed at discharge and at 1, 6, and 12 months in follow-up. Results: In total, 130 stents were placed successfully in 97 (99%) of 98 patients. One stent was misplaced during deployment and required subsequent surgical removal. The average stenosis grade was reduced from 98% to 6% in the SFAs and from 96% to 4% in the iliac arteries after covered stent placement. There was a significant rise of the mean ABI from 0.64 at baseline to 0.97 and 0.95 at 1 and 12 months, respectively (p < 0.001). There were 7 primary covered stent occlusions (6.5% of 107 stented lesions: 3 not treated, 2 bypassed, 2 dilated or stented) and 5 (4.7%) recurrent in-stent occlusions (1 bypassed, 2 dilated, 2 untreated) during the 1-year follow-up. Primary patency rates were 92% at 6 months and 89.8% at 12 months for the entire cohort. Secondary patency rates were 98% and 95.6%, respectively. No statistically significant differences were observed in the primary patency rates for the SFAs (89.3% at both 6 and 12 months) versus the iliac arteries (94.3% at 6 months and 90.7% at 12 months). Conclusions: Primary implantation of PTFE-covered nitinol stents in the iliac and superficial femoral arteries is technically feasible, safe, and effective, with excellent 1-year patency.

Measurements and detection of abdominal aortic aneurysm growth: Accuracy and reproducibility of a segmentation software

PURPOSE To validate the reproducibility and accuracy of a software dedicated to measure abdominal aortic aneurysm (AAA) diameter, volume and growth over time. MATERIALS AND METHODS A software enabling AAA segmentation, diameter and volume measurement on computed tomography angiography (CTA) was tested. Validation was conducted in 28 patients with an AAA having 2 consecutive CTA examinations. The segmentation was performed twice by a senior radiologist and once by 3 medical students on all 56 CTAs. Intra and inter-observer reproducibility of D-max and volumes values were calculated by intraclass correlation coefficient (ICC). Systematic errors were evaluated by Bland-Altman analysis. Differences in D-max and volume growth were compared with paired Students t-tests. RESULTS Mean D-max and volume were 49.6±6.2mm and 117.2±36.2ml for baseline and 53.6±7.9mm and 139.6±56.3ml for follow-up studies. Volume growth (17.3%) was higher than D-max progression (8.0%) between baseline and follow-up examinations (p<.0001). For the senior radiologist, intra-observer ICC of D-max and volume measurements were respectively estimated at 0.997 (≥0.991) and 1.000 (≥0.999). Overall inter-observer ICC of D-max and volume measurements were respectively estimated at 0.995 (0.990-0.997) and 0.999 (>0.999). Bland-Altman analysis showed excellent inter-reader agreement with a repeatability coefficient <3mm for D-max, <7% for relative D-max growth, <6ml for volume and <6% for relative volume growth. CONCLUSION Software AAA volume measurements were more sensitive than AAA D-max to detect AAA growth while providing an equivalent and high reproducibility.