EVToday News

REGULATORY UPDATE
FDA Approves Effient for ACS July 10, 2009—Daiichi Sankyo, Inc. (Parsippany, NJ) and Eli Lilly and Company (Indianapolis, IN) announced that the US Food and Drug Administration has approved Effient (prasugrel) tablets for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndromes (ACS) who are managed with percutaneous coronary intervention (PCI). Daiichi Sankyo and Eli Lilly codeveloped Effient, which was discovered by Daiichi Sankyo and its research partner, Ube Industries, Ltd. (Tokyo, Japan). The companies noted that Effient should be initiated with a loading dose of 60 mg followed by a maintenance dose of 10 mg once daily. In addition, for patients who weigh < 132 lbs (60 kg), physicians should consider lowering the maintenance dose to 5 mg once daily. Patients taking Effient should also take 75 to 325 mg of aspirin orally once daily, as instructed by their doctors. According to the companies, the approval was based on results from the pivotal phase 3 TRITON-TIMI 38 clinical trial, which compared Effient with clopidogrel bisulfate (Plavix, Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership, Bridgewater, NJ) in reducing cardiovascular events in 13,608 ACS patients managed with PCI. The study showed that Effient taken with aspirin had a 19% relative risk reduction of the combined endpoint of cardiovascular death, nonfatal heart attack, or nonfatal stroke versus Plavix taken with aspirin. This benefit was driven predominantly by a reduction in heart attacks. The benefit of Effient compared with Plavix was seen as early as 3 days and continued during the 15 months of the trial. In addition, there were fewer incidents of stent thrombosis in patients treated with Effient compared to Plavix, with a relative risk reduction of approximately 50%. "The data from the TRITON-TIMI 38 phase 3 pivotal trial provide compelling evidence that treatment with prasugrel significantly reduced the combined risk of cardiovascular death, heart attack, or stroke over the current standard of care, clopidogrel, across a wide variety of patient types," commented the trial's lead investigator, Elliott Antman, MD. "Prasugrel is an important new option for patients with ACS who are managed with PCI." Dr. Antman noted that prasugrel was associated with a significantly higher risk of serious bleeding events compared with clopidogrel, but that appropriate patient selection may help reduce this risk. The risk of bleeding was highest in patients treated with Effient who were 75 years of age or older, weighed < 132 pounds (60 kg), or had a history of transient ischemic attacks or stroke. Effient is contraindicated in patients with a history of transient ischemic attack/stroke. It is generally not recommended in patients 75 years of age or older, except for patients in high-risk situations, such as those with diabetes or a history of heart attack. Large-Diameter Gore Viabahn Approved to Treat Iliac Arteries July 21, 2009—W. L. Gore & Associates (Flagstaff, AZ) announced that it has received approval from the US Food and Drug Administration (FDA) to market the latest design for the Gore Viabahn endoprosthesis with heparin bioactive surface for device diameters of 9 to 13 mm for the treatment of peripheral arterial disease (PAD) in the iliac artery. The product enables streamlined deployment on the same 0.035-inch guidewire and tip-to-hub direction as the 5- to 8-mm sizes. Additional modifications to the large-diameter Viabahn include radial device expansion, a contoured proximal edge, and a lower profile that is now available for most sizes. According to Gore, the Viabahn family of endoprosthesis devices features a durable, reinforced, biocompatible, expanded polytetrafluoroethylene liner attached to an external nitinol stent structure. In 2005, the FDA approved the original device configuration of 6- to 8-mm sizes for treating PAD in the superficial femoral artery. In 2007, the company added a 5-mm size, reduced its profile, and added a heparin bioactive surface. In 2008, 9- to 13-mm sizes were approved for improving blood flow in patients with symptomatic PAD in iliac artery lesions. In June 2009, the FDA approved a manufacturing change to the device to remove excess material at the device margin, resulting in a contoured edge at the proximal end. The Viabahn's flexibility enables it to traverse tortuous areas and to conform to the complex anatomy of the artery, the company stated. "The latest improvements to the Gore Viabahn, including a smaller delivery profile and 0.035-inch guidewire compatibility for the larger diameter endografts, will allow us to easily deliver the larger devices to more locations," commented Michael B. Silva Jr, MD. "Treating difficult vascular problems requires good skills and good equipment. The self-expanding, covered Viabahn offers elegant and versatile endovascular solutions to difficult vascular problems." Cook's Zenith TX2 Graft With Pro-Form Approved for TEVAR July 27, 2009—Cook Medical (Bloomington, IN) announced that the US Food and Drug Administration has approved the Zenith TX2 thoracic aortic aneurysm endovascular graft with Pro-Form, which was engineered especially for procedures in which endografts must be positioned in tight aortic arches that are difficult to seal properly. Compared to the company's original TX2 device, the Zenith TX2 graft with Pro-Form has an improved delivery system that provides more controlled deployment. The device helps establish proximal conformity of the device to the aortic wall control during endograft deployment in thoracic endovascular repair, the company stated. Onset's SoloPath Gains CE Mark Approval July 28, 2009—Onset Medical Corporation (Irvine, CA) announced that it has received CE Mark approval to market the SoloPath endovascular access catheter in the European Union. The primary clinical applications for the SoloPath will be to provide quick and safe access of large therapeutic devices through the femoral and iliac arteries into the aortic artery. According to the company, as many as 20% of patients who require replacement aortic heart valves have severe atherosclerotic disease in their leg arteries, which may prevent access of the new percutaneous aortic valves being marketed in Europe by Edwards Lifesciences (Irvine, CA) and Medtronic, Inc. (Minneapolis, MN). Onset's SoloPath is designed to provide access to these diseased arteries with a relatively small catheter size and then be expanded to accommodate the large diameter of percutaneous valve delivery devices. Therefore, the SoloPath may help broaden the number of patients who can be effectively treated with percutaneously implanted aortic heart valves. Another major clinical market for the SoloPath catheter is in the delivery of stent grafts for the treatment of aortic aneurysms. These aortic stent grafts require very large catheter delivery systems. The SoloPath will provide significant clinical advantages in the delivery of these stent grafts, Onset stated. The SoloPath uses Onset's controlled deployment technology in a new approach to procedures requiring minimally invasive access to remote sites within the body. The SoloPath enters the body at approximately one-half the diameter of conventional access sheaths and navigates through the vascular anatomy. Once in position, the device is deployed by radial expansion to expand the sheath and remodel the tissue/vasculature in order to provide unrestricted access for the delivery of therapeutic devices. The company stated that early studies indicate that controlled deployment technology can allow the physician to achieve an easy, one-step access procedure that can potentially reduce vascular/tissue trauma and eliminate the need for other preoperative steps such as vascular stenting, which are often required for access with conventional devices. By eliminating a number of surgical maneuvers, use of the SoloPath may reduce procedural time, surgical expense, and patient recovery time, the company stated. Onset is conducting a multicenter study to further demonstrate the clinical superiority of the SoloPath versus current, conventional access devices. The company expects to launch the SoloPath during the fourth quarter of 2009. EU Approves Nfocus Echo Guiding Catheter July 29, 2009—Nfocus Neuromedical Inc. (Palo Alto, CA) announced that it has earned European CE Mark approval for the Echo distal-access guiding catheter. The company made the announcement at the 6th Annual Meeting of the Society of NeuroInterventional Surgery held July 27 to 31 in Boca Raton, Florida. The Echo has been cleared in Europe to provide support and vessel access in peripheral, coronary, and neurovascular interventional and diagnostic procedures. The guiding catheter is atraumatic and flexible within the distant and smaller target vessel while providing stable and firm support in the larger vessels. The device's unibody construction provides suppleness at the distal end and exceptional support in the proximal section, the company stated. FDA Clears Cook's Advance 35LP Catheter July 15, 2009—Cook Medical (Bloomington, IN) announced that it has received clearance from the US Food and Drug Administration to market the Advance 35LP low-profile balloon dilatation catheter. The device is intended for use in patients with lesions in the femoral, iliac, and renal arteries. The Advance 35LP balloon is compatible with a 0.035-inch wire guide and is designed to address common above-the-knee blockages. According to the company, the Advance 35LP workhorse device joins Cook Medical's Advance product line for the treatment of lesions in the peripheral arteries as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulas. The Advance 18LP is used for the femoral artery and popliteal interventions. The Advance 14LP is reserved for treating the most tortuous anatomies of the lower leg, including the popliteal and infrapopliteal arteries. Each balloon features a low crossing profile and small-sheath compatibility. Advanced thermal setting of the balloon folds improves rewrap and sheath pullback. Double-lumen shaft construction reduces balloon inflation/deflation time and improves pushability while maintaining kink resistance, the company stated.
INDUSTRY NEWS
Terumo Europe Initiates e-MISAGO Registry July 24, 2009—Terumo Europe NV (Leuven, Belgium) announced the initiation of e-MISAGO, a nonrandomized, prospective, multicenter, observational registry with the main objective to validate the safety and efficacy of the company's Misago peripheral self-expanding stent system in real-world patients. According to the company, more than 100 European centers, which will target more than 2,000 patients, are expected to take part in e-MISAGO during the enrollment period scheduled until the end of September 2010. The patients will be followed up at 30 days and 12 months. Terumo Europe also announced the expansion of the Misago stent product range to cover wider indications. In addition to the 6- and 8-mm diameter Misago stents already available, 9- and 10-mm diameter stents, mainly dedicated to iliac arteries, have been added to the product range. The new diameter stents incorporate the Misago product line's rapid-exchange delivery system for precise and easy deployment and for a single-operator technique. The company stated that the Misago stent has been studied in the MISAGO 1 trial, which enrolled 55 patients treated with 83 Misago stents. At 6-month follow-up, the clinical outcomes showed a restenosis rate of 8.5% and a repeat revascularization rate of 3.6%. The results of the ongoing MISAGO 2 study, which enrolled 770 patients in 79 centers, will be presented at the CIRSE 2009 conference to be held September 19 to 23 in Lisbon, Portugal, and at the TCT 2009 conference to be held September 21 to 25 in San Francisco, California. Study Results Presented for Micrus's DeltaPaq July 23, 2009—Micrus Endovascular Corporation (San Jose, CA) announced that study results demonstrated that the company's DeltaPaq microcoil design appears to improve the uniformity of coil distribution within a cerebral aneurysm and the degree of microcoil packing in the aneurysm dome and neck, which may reduce the risk of aneurysm recurrence. The results were presented at the 10th Congress of the World Federation of Interventional and Therapeutic Neuroradiology held June 29 to July 3 in Montreal, Quebec, Canada. Bernard R. Bendok, MD, and Matthew Gounis, PhD, served as principal investigators for the Micrus-sponsored in vitro study. Dr. Benok stated that the objective of this study was to assess whether the type of coil used had an affect on packing density and coil distribution within an aneurysm. "Conventional thinking has been that higher packing density reduces coil compaction and therefore leads to fewer retreatments," commented Dr. Bendok. "This study suggests that the DeltaPaq microcoil may improve uniformity of coil distribution and demonstrated that DeltaPaq had a statistically significant greater packing density compared with traditional helical and complex coil designs. Uniformity of distribution, which was found to be superior with DeltaPaq, is a possible predictor of treatment durability." Ron Benitez, MD, added, "My experience is that with Micrus's Cerecyte coils I see better outcomes than I did when using bare platinum coils. My approach is to frame with 1 or 2 Presidio Cerecyte or MicruSphere coils, followed almost exclusively by DeltaPaq Cerecyte coils. The DeltaPaq coil is more conformable than other filling coils and therefore able to better find open voids in the aneurysm, leading to more complete packing or filling of the aneurysm. I believe that the combination of Cerecyte with DeltaPaq's filling capabilities will lead to a further reduction in my recanalization and retreatment rates." Atrium's ClearWay RX Study Presented July 15, 2009—Atrium Medical Corporation (Hudson, NH) announced that Francesco Prati, MD, presented interim results from the COCTAIL study on the performance of the company's ClearWay RX local therapeutic infusion catheter at the C3/Capital Cardiovascular Conference held June 14 through 17 in Baltimore, Maryland, and at the EuroPCR 2009 meeting held May 17 through 22 in Barcelona, Spain. ClearWay RX is indicated for localized infusion of various diagnostic and therapeutic agents into the coronary and peripheral vasculature. Atrium stated that the COCTAIL study is a multicenter, randomized, and controlled clinical trial. COCTAIL compared local coronary administration of abciximab (ReoPro, Eli Lilly and Company, Indianapolis, IN) through a guide catheter, with local coronary administration of abciximab using the ClearWay RX. The primary objective is to verify whether intracoronary (IC) ClearWay infusion of abciximab is capable of reducing thrombus burden by optical coherence tomography (OCT) as compared to traditional IC guide catheter infusion. The secondary objective is to address whether the administration of abciximab by IC ClearWay RX, as compared to IC guide catheter delivery, can improve macro- and microcirculation postintervention by measuring corrected TIMI frame count (cTFC) and myocardial blush grade. The current interim results are for the first 48 patients. The study will enroll a total of 50 patients. Of the first 48 patients, 39 had evaluable OCT scans, 19 in the ClearWay RX group and 20 in the guide catheter group. The interim results demonstrated that super-selective intracoronary infusion of abciximab through the ClearWay RX catheter significantly reduced thrombus burden as measured by OCT, whereas local guide catheter infusion did not. According to the company, the primary endpoint demonstrated that ClearWay RX significantly reduced the thrombus score by more than 35% (P = .0015), whereas local guide catheter infusion only reduced the thrombus burden by 3.7% (P = NS). There was a statistically significant improvement in the cTFC in the ClearWay RX infusion group compared to the guide catheter infusion group. The ClearWay RX infusion group had an average cTFC of 15.75 versus 20.75 for the guide catheter infusion group (P < .05). The ClearWay RX infusion group had more patients reach a myocardial blush grade of 3, whereas the overall myocardial blush grade showed a trend toward improvement in the ClearWay RX group that was not statistically significant. Additionally, the interim results after intervention showed that the ClearWay RX group had a diameter stenosis of 5.9% versus 11.9% for the guide catheter group (P = .015). The company advised that these findings and this treatment strategy will be further tested in a large, multicenter, randomized, controlled trial known as INFUSE AMI with Principal Investigator Gregg Stone, MD, and Coprincipal Investigator C. Michael Gibson, MD. Terumo Launches New Pinnacle R/O II Sheaths June 25, 2009—Terumo Interventional Systems (Somerset, NJ) announced the expansion of its Pinnacle R/O II radiopaque marker introducer sheaths, which are now available in 4- to 9-F sizes with 6-, 10-, and 25-cm lengths. The company stated that the 10- and 25-cm lengths are appropriate for interventional procedures such as balloon angioplasty or stent placement or with ipsilateral approaches. The 6-cm sheath can be used for superficial access sites. The 4- to 9-F sizes with 6- and 10-cm lengths are also available with mini guidewires (a 0.035-inch wire with 4-F sizes, a 0.038-inch wire for all others). According to Terumo, the Pinnacle R/O II enables interventionists to know the exact sheath tip location during a procedure. Its long, gradual taper on the dilator and sheath leads to easier insertion with less force, which may result in reduced trauma and reduced complications. The Pinnacle R/O II maintains kink resistance, reducing the need for a second sheath, the company stated. Societies Object to Proposed Angioplasty Coding Changes June 18, 2009—On its Web site, The Society of Cardiovascular Angiography and Interventions (SCAI, www.scai.org) has posted a letter to Niles R. Rosen, MD, Medical Director of the National Correct Coding Initiative (NCCI), in response to the Centers for Medicare & Medicaid Services (CMS) and NCCI's April 16 letter proposing coding changes that relate to coverage for angioplasty procedures. SCAI, along with the American College of Cardiology, American College of Radiology, American Roentgen Ray Society, Radiological Society of North America, Society for Vascular Surgery, and Society of Interventional Radiology, wrote to oppose the edits and revisions to the NCCI Policy Manual for Medicare Services that would disallow percutaneous catheter-based angioplasty from being reported with atherectomy when performed in the same noncoronary vessel at the same setting. The societies stated that the proposed edits are in direct conflict with the American Medical Association's currently established national coding conventions for correct coding of percutaneous catheter-based therapeutic interventions. The April 16 letter also addressed NCCI edits for simultaneous open and percutaneous angioplasty, as well as simultaneous open and percutaneous atherectomy. Current coding conventions state that multiples of the same intervention (angioplasty, atherectomy, etc.) are only reported once per vessel. However, there are situations when bilateral procedures may be performed or separate vessels are treated within either leg, the societies stated. Cook's REFORM Trial Completes Enrollment June 15, 2009—Cook Medical (Bloomington, IN) announced the completion of patient enrollment in the REFORM clinical trial of its Formula balloon-expandable stent for treating renal artery stenosis. The trial is designed to evaluate the safety and effectiveness of the Formula device for treating renal artery atherosclerosis against well-established performance data. Investigators enrolled 100 patients at seven sites in the United States. Initial clinical results on the trial's endpoint of revascularization of the target lesion to perfuse the kidney measured at 9 months postprocedure are expected to be available in the second quarter of 2010. US Food and Drug Administration regulatory submissions are expected to be made based on those data, stated the company. "The REFORM trial completed enrollment in record time considering the small number of select investigative sites invited to participate in the trial," commented REFORM Principal Investigator Robert Bersin, MD. "The speed with which enrollment was completed speaks to the comfort the operators, including myself, have with the performance of this dedicated renal stent platform. The acute outcomes have been nothing but superb. The trial is now in follow-up, and we are confident that long-term patient outcomes will be as good as the acute outcomes we observed."
LITERATURE HIGHLIGHTS
Effect of Femoropopliteal Stent Fracture on Patency Studied July 20, 2009—In the Journal of the American College of Cardiology: Cardiovascular Interventions, Osamu Iida, MD, et al published findings from their investigation of the time course of stent patency in the femoropopliteal artery for as long as 4 years (2009;2:665–671). The investigators noted that stent fracture has been related to poor 2-year patency in the femoropopliteal artery. According to the investigators, they studied 239 consecutive patients who underwent provisional de novo stenting with nitinol stents for 333 limbs (Luminexx stent [Bard Peripheral Vascular, Inc., Tempe, AZ] in 91 limbs; Smart stent [Cordis Corporation, Bridgewater, NJ] in 242 limbs) from April 2004 to December 2007. Stent fracture was determined by x-ray with multiple projections. Patency was assessed by Duplex ultrasonography as peak systolic velocity ratio < 2.4 or by angiography (% diameter stenosis < 50%). Primary patency in patients with and without stent fracture at follow-up was assessed along with factors influencing stent fracture. The investigators reported that primary patency was 81%, 74%, 68%, and 65% at 1, 2, 3, and 4 years, respectively. Stent fracture occurred in 14% (78 of 544) of stents and 17% (55 of 333) of limbs. Stent fracture was significantly associated with multiple stent deployments (with fracture, 2.3 ± 0.9 stents vs without fracture, 1.5 ± 0.7 stents; P < .001) and long lesions (with fracture, 208 ± 84 mm vs without fracture, 121 ± 79 mm; P < .001). Primary patency was 68% with fracture versus 83% without fracture at 1 year (P = .03); 65% versus 75% at 2 years (P = .05); 61% versus 69% at 3 years (P = .06); and 61% versus 65% at 4 years (P = .07). Neither type 1 nor type 3 fracture affected patency, although type 2 showed the worst patency. The investigators concluded that stent fracture worsened the patency during the first 2 years, but it apparently did not affect patency beyond 2 years. In particular, complete stent separation did not affect patency. Trends in Treating Lower Extremity PAD Studied July 1, 2009—The Society for Vascular Surgery announced that Philip P. Goodney, MD, et al have published a study in the Journal of Vascular Surgery, assessing national trends in comparative treatments for lower extremity peripheral arterial disease (PAD) (2009;50:54–60). The investigators found that endovascular interventions are now performed much more commonly than bypass surgery when treating lower extremity PAD. They noted that these changes far exceed simple substitution; in fact, more than three additional endovascular interventions were performed for every one procedure declined in lower extremity bypass surgery. During this same time period, major lower extremity amputation rates have fallen by more than 25%. However, further study is needed before any causal link can be established between lower extremity vascular procedures and improved rates of limb salvage in patients with PAD, the investigators concluded. According to the investigators, advances in endovascular interventions have expanded the options that are available for the invasive treatment of lower extremity PAD. Whether endovascular interventions substitute for conventional bypass surgery or they are simply additive has not been investigated, and their effect on amputation rates is unknown. Therefore, the investigators sought to analyze trends in lower extremity endovascular interventions (angioplasty and atherectomy), lower extremity bypass surgery, and major amputation (above and below the knee) in 100% samples of Medicare Part B beneficiaries between 1996 and 2006. Using physician specialty identifiers, the investigators also examined trends in the specialty performing the primary procedure. As detailed in the Journal of Vascular Surgery, from 1996 to 2006, the rate of major lower extremity amputation declined significantly (263 to 188 per 100,000; risk ratio [RR] 0.71; 95% confidence interval [CI], 0.6–0.8). Endovascular interventions increased more than threefold (from 138 to 455 per 100,000; RR = 3.3; 95% CI, 2.9–3.7), whereas bypass surgery decreased by 42% (219 to 126 per 100,000; RR = 0.58; 95% CI, 0.5–0.7). The increase in endovascular interventions consisted both of a growth in peripheral angioplasty (from 135 to 337 procedures per 100,000; RR = 2.49; 95% CI, 2.2–2.8) and the advent of percutaneous atherectomy (from 3 to 118 per 100,000; RR = 43.12; 95% CI, 34.8–52). Investigators noted that percutaneous atherectomy is a particularly new, expensive, and relatively untested treatment; however, its rate of use has increased by more than 4,100%. In 1996, radiologists performed the majority of endovascular interventions, but by 2006, more than 80% of interventions were performed by cardiologists and vascular surgeons. Overall, the total number of all lower extremity vascular procedures nearly doubled during the decade (from 357 to 581 per 100,000; RR = 1.63; 95% CI, 1.5–1.8), reported the investigators. "We suspect new procedures may have translated into better outcomes, given the significant decline in amputation rates," commented Dr. Goodney. "However, other aspects of healthcare provided to patients at risk for amputation have changed along with the rates of surgical and endovascular procedures. Medicare patients are much more likely to receive medical and podiatric care, such as cholesterol monitoring, diabetic foot examinations, and blood glucose monitoring, which are aimed more toward preventing amputation now than they were 10 years ago. Our future work aims to determine if amputation rates are falling because of better medical care, changes in revascularization strategies, or a combination of the two." Dr. Goodney stated that larger and broader clinical trials should compare bypass and endovascular interventions in patients with claudication and critical limb ischemia to further evaluate what medical steps can be taken and what resources should be used to obtain the best functional outcomes in patients with PAD and to prevent death and disability from lower extremity amputation. Stroke Treatment Standards Published July 29, 2009—Philip M. Myers, MD, et al have published performance and training standards for endovascular treatment of ischemic stroke treatment in the Journal of Neurointerventional Surgery (2009;1:10–12). According to the writing group, the purpose of the document is to define what constitutes adequate training to perform neuroendovascular procedures in patients with acute ischemic stroke and what performance standards should be adopted to assess outcomes. The guidelines have been written and approved by multiple neuroscience societies that have been directly involved in the medical, surgical, and endovascular care of patients with acute stroke. The participating member organizations of the Neurovascular Coalition involved in the writing and endorsement of this document are the Society of NeuroInterventional Surgery, the American Academy of Neurology, the American Association of Neurological Surgeons/Congress of Neurological Surgeons Cerebrovascular Section, and the Society of Vascular and Interventional Neurology. The document's introduction notes that endovascular therapy for patients with acute ischemic stroke is an area of intense investigation. The American Stroke Association has given a qualified endorsement of intra-arterial thrombolysis in selected patients. Intra-arterial thrombolysis has been studied in two randomized trials and numerous case series. Although two devices have been granted US Food and Drug Administration approval with an indication for mechanical stroke thrombectomy, none of these thrombectomy devices have demonstrated efficacy for the improvement of patient outcomes, the document states. American Heart Association Publishes Statement on Telemedicine for Stroke July 1, 2009—In Stroke, the American Heart Association has published a policy statement by Lee H. Schwann, MD, et al that provides recommendations for the implementation of telemedicine within stroke systems of care (2009;40:2635–2660). According to the statement, telestroke is defined as consultations that involve a physician who is a stroke expert using a high-quality, bidirectional audio and videoconferencing system to interact with a bedside provider and/or patient/caregiver for the purposes of delivering stroke care or advice. It is not a new medical therapy per se; rather, it is a method used to overcome barriers to the delivery of proven, evidence-based therapies that might otherwise be unavailable for stroke patients. In this context, telemedicine can help to establish an organized stroke systems-of-care model (SSCM) and increase utilization of intravenous thrombolysis and stroke unit care. Telestroke can enable the initiation of cost-effective interventions that have been proven to reduce complications and stroke recurrence and can identify and facilitate transfer of patients in the community for specific tertiary care interventions such as neurointensive care, decompressive surgery for life-threatening, space-occupying cerebral infarction, and prompt surgical or endovascular repair of ruptured cerebral aneurysms. Regarding endovascular therapy and the use of telemedicine for stroke treatment, the statement notes that catheter-based reperfusion (eg, chemical thrombolysis, thromborrhexis, clot retrieval, angioplasty, and/or stenting) may confer benefit in carefully selected patients with acute ischemic stroke who are not eligible for intravenous tissue plasminogen activator thrombolysis or who have failed to respond to it. Although the window for initiation of catheter-based mechanical clot retrieval may be up to 8 or 9 hours after symptom onset, there are currently only 385 interventional neuroradiologists in the United States practicing in 238 hospitals in 45 states. The ability to increase the proportion of ischemic stroke patients who are transported to centers that can provide reperfusion therapy will rely on increased training of appropriate specialists, although it might result in significant cost savings for the healthcare system that could potentially offset the initial capital costs associated with improved diagnostics or interfacility transport. Also in Stroke, the American Heart Association/American Stroke Association published a scientific statement by Dr. Schwamm, et al that is a review of the evidence for using telemedicine within SSCMs (2009;40:2616–2634). As noted in the statement, it aims to provide a comprehensive and evidence-based review of the scientific data evaluating the use of telemedicine for stroke care delivery and to provide consensus recommendations based on the available evidence. Evidence-based recommendations are included for the use of telemedicine in general neurological assessment and primary prevention of stroke, notification and response of emergency medical services, acute stroke treatment including the hyperacute and emergency department phases, hospital-based subacute stroke treatment and secondary prevention, and rehabilitation. Surgery After eEVAR of Ruptured AAA Analyzed July 1, 2009—In a study published in the Journal of Vascular Surgery, Dieter Mayer, MD, et al retrospectively analyzed 102 patients with ruptured abdominal aortic aneurysms (rAAAs) that were treated with emergency endovascular aneurysm repair (eEVAR) from January 1998 to April 2008 (2009;50:1–7). The investigators stated that the background of the study is that open abdomen treatment (OAT) is considered a lifesaving procedure in patients with abdominal compartment syndrome (ACS) after endovascular or open intervention for rAAA. Standardized treatment methods and algorithms for its use are still lacking. The published high mortality rates may reflect difficulties in detecting and treating ACS, especially in patients treated with eEVAR. This study presented standardized algorithms for OAT, including a new technique using a vacuum-assisted closure (VAC) system developed during 10 years of experience with eEVAR for rAAA. In the study, abdominal decompression was performed when intravesical pressure was > 20 mm Hg or when abdominal perfusion pressure was < 50 to 60 mm Hg and concomitant organ deterioration occurred. OAT was initially done with a subcutaneously sutured plastic bag or with a nonsutured zipper drape combined with the VAC/Ethizip (KCI International Inc., Amstelveen, The Netherlands; Ethicon, Somerville, NJ). All patients were switched to VAC/Ethizip as soon as possible. Dressings were generally changed every 3 to 5 days. Intra-abdominal pressure was monitored until stability was observed after delayed direct abdominal closure. The investigators reported that 30-day mortality for eEVAR was 13% (13 of 102) overall, 8% (7 of 82) for patients without ACS, and 30% (6 of 20) for those with ACS. Decompression for ACS was needed in 20 patients (20%) primarily during the intervention (n = 14) or secondarily in the intensive care unit (n = 6). Six of 20 (30%) patients requiring OAT died at ≤ 30 days (4 primary, 2 secondary). A mean of 3.6 (range, 1–12) planned second-look interventions were done per patient at an interval of 3 to 5 days. No bowel lesions were observed. Four patients required antibiotic therapy for abdominal infection, and all infections were resolved. Delayed abdominal wall closure (direct closure, 11; closure with polypropylene mesh, 3; bilateral anterior rectus abdominis sheath turnover flap, 1) was achieved after a median of 6 days (range, 1–47 days). The investigators concluded that the use of standardized novel techniques and a treatment protocol and algorithm for OAT after eEVAR for rAAA were feasible and safe. It decreased the workload of the medical and nursing staff, enhanced patient comfort because the need for dressing changes was minimized, and likely contributed to lower overall mortality in rAAA patients. Delayed direct fascial closure was possible in most patients, added the investigators. Cook's Günther Tulip VCF Shows Long-Term Retrievability July 2, 2009—In the Journal of Vascular and Interventional Radiology, H. Bob Smouse, MD, et al published findings from a study conducted to evaluate the likelihood of successful retrieval of the Günther Tulip vena cava filter (VCF) (Cook Medical, Bloomington, IN) after various implant durations of up to 494 days (2009;20:871–877). Retrievable Günther Tulip VCFs were placed in 554 patients. All patients satisfied the requirements for filter placement. The primary indication for placement was specified for 394 patients (71%) as follows: unspecified trauma (n = 164), bariatric procedures (n = 128), orthopedic procedures (n = 36), and other (n = 66). Filter tilt and vena cava injury were assessed at implantation. Filters were not repositioned after placement. At retrieval, filter orientation, vena cava injury, other device-related incidents, and the degree of difficulty associated with retrieval were reported. According to the investigators, VCF retrieval was attempted in 275 patients and was successful in 248 (90.2%). The mean filter indwell time was 58.9 days (range, 3–494 days). Unsuccessful retrievals (n = 27) were attributed primarily to improper hook orientation (n = 10) or excessive tissue ingrowth at the filter legs (n = 16). Of the remaining 279 patients, 223 withdrew from the study, 41 were associated with a decision to keep the filter as a permanent device, 13 died for reasons unrelated to the study, and 2 had no reported endpoint data. A Kaplan-Meier product-limit survival estimate revealed that the probability of successful device retrieval remained at > 94% at 12 weeks and > 67% at 26 weeks. This study contributes to the body of clinical data related to retrievable filters demonstrating reliable retrieval rates at 12 weeks, with successful retrievals up to 17 months after implantation, the investigators concluded. Study Supports Retrievability of Bard G2 IVC Filter July 29, 2009—In the Journal of Vascular and Interventional Radiology, Hearns W. Charles, MD, et al published findings from a study that was conducted to assess the retrievability of the G2 inferior vena cava (IVC) filter (Bard Peripheral Vascular, Tempe, AZ) and factors influencing the safety and technical success of retrieval (2009;20:1046–1051). In the study, G2 IVC filters were placed in 140 consecutive patients who needed prophylaxis against pulmonary embolism (PE). General indications for filter placement included history of thromboembolic disease (n = 98) and high risk for PE (n = 42). Specific indications included contraindication to anticoagulation (n = 120), prophylaxis in addition to anticoagulation (n = 16), and failure of anticoagulation (n = 4). Filter indwell time, technical success of filter retrieval, and complications related to placement or retrieval were retrospectively evaluated in patients who underwent filter removal. The investigators reported that among the 140 patients who had a G2 IVC filter placed, 27 attempts at filter retrieval were made in 26 patients (1 patient had placement and retrieval of 2 G2 filters over the course of the study). All 26 patients had successful filter retrievals, resulting in a technical success rate of 100%. The mean indwell time was 122 days (range, 11–260 days). These findings demonstrated that there is a high technical success rate associated with the retrieval of the G2 filter that does not appear to be limited by filter tilting. In addition, there appears to be a very low complication rate. In the short term, the it appears that the G2 filter appears to beis associated with a low rate of thrombosis, a low rate of symptomatic PE, a high technical success rate for retrieval, and a good retrieval safety profile, the investigators concluded.Ên