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Purpose The present study was designed to address the hypothesis that radiofrequency (RF) thermal ablation, as represented by the ClosureFAST system, is associated with improved recovery and quality-of-life (QOL) parameters compared with 980-nm endovenous laser (EVL) thermal ablation of the great saphenous vein (GSV). Materials and Methods Eighty-seven veins in 69 patients were randomized to ClosureFAST or 980-nm EVL treatment of the GSV. The study was prospective, randomized, single-blinded, and carried out at five American sites and one European site. Primary endpoints (postoperative pain, ecchymosis, tenderness, and adverse procedural sequelae) and secondary endpoints (venous clinical severity scores and QOL issues) were measured at 48 hours, 1 week, 2 weeks, and 1 month after treatment. Results All scores referable to pain, ecchymosis, and tenderness were statistically lower in the ClosureFAST group at 48 hours, 1 week, and 2 weeks. Minor complications were more prevalent in the EVL group ( P = .0210); there were no major complications. Venous clinical severity scores and QOL measures were statistically lower in the ClosureFAST group at 48 hours, 1 week, and 2 weeks. Conclusions RF thermal ablation was significantly superior to EVL as measured by a comprehensive array of postprocedural recovery and QOL parameters in a randomized prospective comparison between these two thermal ablation modalities for closure of the GSV.

PURPOSE To determine early and late outcomes of transluminal endografting (TE) in patients with abdominal aortic aneurysm (AAA), stratified by predicted risk of procedure-related mortality with conventional operation. MATERIALS AND METHODS A retrospective study was conducted in consecutive risk-stratified AAA patients undergoing TE at a not-for-profit cardiovascular referral center from March 1994 through November 2000 with follow-up through February 2001. With use of conventional risk strata (0= low, 1=minimal, 2=moderate, and 3=high), predicted procedure-related mortalities were 0%–1% in stratum 0 ( n = 40), 1%–3% in stratum 1 ( n = 118), 3%–8% in stratum 2 ( n = 116), and 8%–30% in stratum 3 ( n = 31). Main outcome measures were: (i) TE procedural success, (ii) procedure-related mortality, (iii) major nonfatal complications, (iv) composite adverse outcome (ii 1 iii), (v) length of stay (LOS), (vi) freedom from AAA rupture, (vii) late survival, (viii) late complications, and (ix) endoleaks and their classification and management. RESULTS Women were significantly less likely than men to qualify for and undergo endografting: 24 of 91 (26.4%) women underwent TE, compared to 281 of 684 (41.1%) men. Of 305 attempted TE procedures, 291 (95.4%) were successful, four (1.3%) were urgently converted to open repair, and 10 (3.3%) were aborted. Procedure-related mortalities occurred in eight cases (2.6%) overall and one of 40 (2.5%), one of 118 (0.8%), four of 116 (3.4%), and two of 31 (6.5%) cases for risk strata 0–3, respectively. Perioperative survivors were significantly younger than nonsurvivors (74.3 y ± 9 vs 81.6 y ± 5.1; P = .0087). Forty-six patients (15.1%) had major complications. Composite adverse outcome was worse for patients in stratum 3 than those in stratum 1 ( P = .0296) and those in strata 0, 1, and 2 combined ( P = .026). Procedure-related mortality declined with institutional experience, from 4% among the first 100 patients undergoing TE to 1% among the last 105. For strata 0–3, median LOS were 2, 3, 3, and 4 days, respectively. Seventy patients (22.9%) had 75 endoleaks, of which 30 necessitated additional procedures, 17 self-resolved, and 22 were untreated as of March 1, 2001. Five patients with endoleak died of unrelated causes. One late-onset type IA endoleak (26 mo) resulted in the only AAA rupture and death in the follow-up period among the 291 patients who underwent successful transluminal endograft implantation. Actuarial survival rates at 1 year after TE were 90.3% ± 1.9% for the overall study group and 97.5% ± 2.5%, 94% ±2.5%, 86.9% ±3.3%, and 81.3% ±7.7% for risk strata 0–3, respectively. At 5 years, overall actuarial survival was 69.6% ±6.1%. Thirty-eight late deaths were attributable to post-TE AAA rupture ( n = 1), AAA rupture late after failed TE with no further treatment ( n = 1), other cardiovascular disorders ( n = 7), cancer ( n = 15), other causes ( n = 10), and unknown causes ( n = 4). Late deaths occurred in risk strata 0–3 at the following rates: two of 40 (5%), 10 of 118 (8.5%), 16 of 116 (13.8%), and 10 of 31 (32.3%), respectively (stratum 0 vs stratum 3, P = .0017; stratum 1 vs stratum 3, P = .003). CONCLUSIONS TE is safe and confers durable protection against AAA rupture in treated populations. Still, protection is not absolute in patients with endoleaks, because late AAA enlargement and even rupture can occur. Given current knowledge, technology, and practice, careful patient selection and close surveillance of patients after implantation of transluminal endografts is essential.

Purpose Platinum embolization coils produce significant CT artifacts and require multiple devices to occlude vessels. A polymer coil-plug represents an attractive alternative, offering minimal CT artifact and occlusion in a single delivery sequence. Here, we report on the short and long-term vascular occlusion capability and biocompatibility of the novel MedusaTM Vascular Plug. Materials and Methods The MedusaTM Vascular Plug (MVP) is constructed from a radiopaque polymer and is a single unit multi-coiled design. MedusaTM Vascular Plugs (EndoShape Inc., Boulder, CO) were delivered into 72 vessels in 17 acute ovine and porcine studies and in 13 arteries in 13 chronic (26 weeks) ovine studies with contralateral metal coil controls. Devices were evaluated for occlusion time in small and large arteries and veins. Extensive laboratory biocompatability testing was also conducted on the MVP. Results In the acute studies, the MedusaTM Vascular Plugs were deployed into 61 deep femoral, femoral, common femoral, and iliac arteries ranging from 4.8 to 9.4 mm diameter (mean 6.1 mm) and in 11 hypogastric, femoral, common femoral, renal, external iliac, and uterine veins from 4 to 10 mm (mean 7 mm). Vessel occlusion was confirmed in all vessels after fluoroscopic contrast injection. The MVP formed a single compact coil pack in all studies with minimal CT artifact. Arterial occlusion times ranged from 1 to 11 minutes (mean 3.8 minutes) and venous occlusion times ranged from 0.3 to 5.5 minutes (mean 2.2 minutes). In the chronic studies, vascular occlusion was compared to contra-lateral metal coil packs (Cook SST coils, Bloomington, IN) at 21 days and 1, 3, and 6 months. At the specified end points, the MedusaTM Vascular Plugs produced occlusion in 12 of 13 animals. The control coils were occluded in 5 of 13 animals. The MVP passed 15 biocompatability tests, including toxicity, mutagenicity, pyrogenicity, cytotoxicity, and hemolysis (NAMSA and Nelson Labs). Conclusion The MedusaTM Vascular Plug provides complete occlusion of a wide variety of sizes and types of blood vessels. Durable occlusion has been confirmed in long term studies. This radiopaque polymer vascular plug may offer an attractive option to platinum embolic coils.