EVToday News
| REGULATORY UPDATE |
FDA Clears Cook's Celect for Retrievability Indication
March 18, 2008—Cook Medical (Bloomington, IN) announced that the FDA granted 510(k) clearance for the Celect vena cava filter for the prevention of recurrent pulmonary embolism via placement in the vena cava and now can be optionally retrieved when clinically indicated. In 2007, the FDA cleared the Celect filter for permanent placement. In 2006, the Celect filter was approved for permanent and retrieval indications in Canada, Australia, and Europe. Cook Medical's Günther Tulip vena cava filter was first approved for use in Europe in 1992 and received FDA clearance in October 2000 for permanent placement and in October 2003 for retrievable use.
Japan Approves Cordis's Carotid Devices for Reimbursement
April 1, 2008—Johnson & Johnson K.K. Medical Company (Tokyo, Japan) announced it has received reimbursement approval from the Japanese Ministry of Health, Labor, and Welfare for the Precise nitinol stent and Angioguard XP emboli capture guidewire devices (Cordis Corporation, a Johnson & Johnson company, Warren, NJ) for the treatment of carotid artery disease. According to the company, the Precise and Angioguard XP are the first carotid devices approved and reimbursed in Japan to treat carotid artery disease in patients at high risk for adverse events from a carotid endarterectomy. Use of the Precise and Angioguard XP is supported by the large, randomized clinical SAPPHIRE trial, which demonstrated the potential benefits of carotid artery stenting in patients who are ineligible, or considered high-risk, for a carotid endarterectomy. The Cordis carotid system has been studied in more than 3,000 patients across both SAPPHIRE and the Carotid Artery Stent Education System PostMarketing Study (CASES-PMS) and demonstrated low stroke rates in both.
"The reimbursement approval of Precise and Angioguard in Japan represents a major advance in the minimally invasive treatment of patients at risk of stroke with carotid artery disease," commented neurosurgeon Nobuyuk Sakai, MD, PhD, of Kobe City General Hospital. "We anticipate many patients who are either ineligible or at high risk for traditional surgery will strongly benefit from this new breakthrough treatment option."
FDA Approves Gore's REVISE Study
April 7, 2008—Gore & Associates (Flagstaff, AZ) announced that the FDA has approved the company's REVISE (Vascular Access Revision with Viabahn Endoprosthesis vs Percutaneous Transluminal Angioplasty [PTA]). REVISE is a randomized, multicenter clinical trial intended to establish efficacy and safety of the Gore Viabahn with Propaten bioactive surface, which uses a proprietary end-point covalent bonding mechanism of heparin, to revise arteriovenous grafts at the venous anastomosis in hemodialysis patients. The study will randomize patients to the Viabahn and to PTA. The company expects study enrollment to begin in spring 2008.
"The study is designed to demonstrate the clinical benefit of using a stent graft for arteriovenous graft revisions, rather than PTA alone," commented Tom Vesely, MD, Medical Director of the REVISE study. "With a focus on target lesion primary patency, the study is designed to show an increased amount of time between interventions in dialysis access grafts."
CE Mark Approved for Lumen's FiberNet EPS in SVG
March 27, 2008—Lumen Biomedical, Inc. (Plymouth, MN) announced CE Mark approval for the company's FiberNet embolic protection system (EPS) in saphenous vein graft (SVG) interventions. The FiberNet EPS is a three-dimensional depth filter composed of polymeric fibers with the ability to capture particles as small as 40 µm. The FiberNet filter allows for placement in distal lesions, thus providing physicians with additional options in SVG recanalization. Robert L. Feldman, MD, is the top enroller in the US investigational device exemption trial, Evaluating the Use of the FiberNet Embolic Protection System in Saphenous Vein Grafts: The RETRIEVE study.
"I have used many distal and proximal devices for embolic protection when treating saphenous vein graft disease," commented Dr. Feldman. "The FiberNet filter is the most effective distal protection device I have used; the ease of use is excellent."
FDA Reinforces Need for Continued Surveillance of EVAR Patients
March 17, 2008—Daniel G. Schultz, MD, the Director of the FDA's Center for Devices and Radiological Health (CDRH) issued a public health notification (PHN) updating data on mortality associated with Medtronic Vascular's (Santa Rosa, CA) AneuRx stent graft system. According to Dr. Schultz, this notification is made to re-emphasize the need for continued surveillance of patients treated with endovascular grafts and to provide physicians with updated information on the mortality risks associated with the use of the AneuRx device to prevent abdominal aortic aneurysm (AAA) rupture. Medtronic stated that this PHN is consistent with the company's 5-year clinical data update, which was distributed with the October 2007 issue of Endovascular Today.
Dr. Schultz stressed that this notification focuses on the AneuRx system because it is the only currently marketed device with a significant number of patients with clinical follow-up at 5 years. Medtronic noted that as one of the first commercially available AAA stent grafts approved in the US, the AneuRx system has the longest and largest dataset of patients treated with early stent graft devices. The other devices on the market are the Powerlink (Endologix, Inc., Irvine, CA), the Excluder (Gore & Associates, Flagstaff, AZ), and the Zenith (Cook Medical, Bloomington, IN). The CDRH's complete notification with recommendations is available online at www.fda.gov/cdrh.
According to Dr. Schultz, the CDRH's earlier notifications suggested an increasing trend in aneurysm-related mortality (ARM) among AneuRx graft patients. The CDRH had estimated that late ARM was approximately 0.4% per year. The CDRH now has additional, longer-term data that suggest that ARM continues to increase after 3 years from the implant, reaching 1.3% by year 4 and 1.5% by year 5. These rates are substantially higher than the mortality rate for open surgical repair, which averages 0.18% per year with a range of 0% to 0.3% per year, stated Dr. Schultz.
Medtronic responded that the CDRH's analysis focused on late ARM and did not cover the early benefits of endovascular aneurysm repair. The company noted that recent level-1 evidence from the UK EVAR-1 trial published in The Lancet showed the short-term benefits of endovascular repair (1.7%) versus open surgical repair (4.7%) are significant and are consistent with the AneuRx (2005;365:2179-2186). This benefit was sustained out to 4 years as demonstrated by the EVAR-1 trial results. The FDA analysis estimated an average 0.18% per year mortality rate for open surgical repair, which was based on a review of historical published literature. Based on the EVAR-1 trial, the average mortality rate for open repair was 0.58% per year. The cumulative long-term freedom from ARM of 96% from the EVAR-1 endovascular group compared favorably to the AneuRx freedom from ARM at 4 years of 96%. Additionally, the EVAR-1 surgical control group freedom from ARM was 93% at 4 years, the company stated.
According to the CDRH, clinicians should consider the information available in the product labels and in the yearly clinical updates from Medtronic and other graft manufacturers when selecting treatment options for patients with AAAs and in following previously treated patients.
The clinical updates for three of the currently marketed AAA endovascular grafts, the AneuRx, Powerlink, and Excluder, are available online at www.medtronic.com/physician/aneurx/experience, www.endologix.com/health_clinical.php, and www.goremedical.com/excluder/annualupdate.html. The Cook Zenith clinical update can be obtained by request at www.cookmedical.com/home.do.
FDA Approves Pivotal Study of PLC Systems' RenalGuard
March 20, 2008—PLC Systems Inc. (Franklin, MA) announced that it has received conditional approval from the FDA to begin enrollment in a US pivotal trial to study the effectiveness of the company's RenalGuard therapy and RenalGuard system in the prevention of contrast-induced nephropathy. Principal Investigators are Charles Davidson, MD, and Richard J. Solomon, MD. The study is designed as an adaptive, randomized controlled trial at up to 30 sites in the US. Enrollment in the trial is expected to last through 2009 and will include a minimum of 246 patients.
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| INDUSTRY NEWS |
Boston Scientific Sells TriVascular EVAR Program
March 31, 2008—Boston Scientific Corporation (Natick, MA) announced the sale of Boston Scientific Santa Rosa Corp., formerly known as TriVascular, Inc., to TriVascular2 Holding Company (TV2, Santa Rosa, CA), a privately held company that was newly formed to develop novel endovascular repair devices to treat abdominal aortic aneurysms. Boston Scientific Santa Rosa Corp. holds equipment and intellectual property related to the TriVascular endovascular aortic repair (EVAR) program. Terms of the sale include $30 million in cash paid at closing to Boston Scientific and a warrant allowing Boston Scientific to purchase a minority interest in TV2. In April 2005, Boston Scientific acquired TriVascular, which was founded to develop EVAR devices and procedures for treating abdominal aortic aneurysms. In 2006, Boston Scientific discontinued its EVAR program and subsequently elected to sell TriVascular as part of a previously announced plan to divest nonstrategic assets.
TV2 announced receipt of a $65 million Series A preferred financing led by MPM Capital (South San Francisco, CA) and New Enterprise Associates, Inc. (NEA, Menlo Park, CA) to acquire the Boston Scientific property. Other investors in the new company are Delphi Ventures (Menlo Park, CA) and Kearny Venture Partners (San Francisco, CA), successor funds of the largest institutional shareholders of TriVascular, Inc., before its acquisition by Boston Scientific. Michael Chobotov, PhD, will be TV2's President and Chief Executive Officer, the role he held prior to the company's acquisition by Boston Scientific. He will be joined by two other key founders of the original TriVascular, Robert G. Whirley, PhD, as the company's Vice President, Research and Development, and Joseph W. Humphrey, PhD, as Vice President, Manufacturing Technologies, TV2 stated.
Gore Commences PRODIGY Study
March 28, 2008—Gore & Associates (Flagstaff, AZ) announced that Principal Investigator Richard Neville, MD, enrolled the first patient in the Gore PRODIGY (Comparison of Primary Patency Between Gore Propaten Vascular Graft and Disadvantaged Autologous Vein Graft for Below-Knee Arterial Bypass) study at Georgetown University Medical Center. PRODIGY is a prospective, randomized, multicenter study designed to demonstrate noninferiority in patency performance of the Propaten vascular graft as compared to disadvantaged autologous vein graft in a below-knee peripheral bypass application. The study will enroll approximately 280 patients at 20 centers in the US. The patients will be followed for 3 years and will be evaluated for several other secondary outcomes including safety, quality of life, and limb salvage.
According to the company, the FDA cleared the Propaten vascular graft in November 2006 for peripheral use, including lower limb bypass and dialysis access surgery. The device features the anticoagulant heparin, which is anchored to the luminal surface. The device is designed to address the gap in clinical performance between synthetic and vein grafts by bonding heparin to the surface of the graft using a proprietary end-point covalent bonding mechanism.
"An autologous greater saphenous vein is considered to be the gold standard for bypass procedures below the knee; however, it may not always be available or may be of poor quality, and prosthetic grafts have not worked well in the past," commented Dr. Neville. "However, initial studies have shown the Propaten vascular graft to be clinically effective with results approaching those of venous conduits. This landmark clinical trial will provide the medical community with valuable data that speak to the performance of the Propaten vascular graft as compared to venous conduits in these difficult clinical situations where the limb is often at risk."
Abraxis Initiates Phase 2 Study of Coroxane for Restenosis Prevention
April 2, 2008—Abraxis BioScience, Inc. (Los Angeles, CA) announced it has initiated enrollment in its phase 2 clinical trial to evaluate the efficacy and safety of Coroxane for the prevention and reduction of restenosis following revascularization of the superficial femoral artery. Coroxane (nanometer-sized paclitaxel, Abraxane, marketed under the trade name Coroxane) is a novel, solvent-free, albumin-bound form of paclitaxel used for cardiovascular applications. Abraxane is the first approved protein-bound nanometer-sized solvent-free taxane and is the first commercial product to validate Abraxis's proprietary nab (nanoparticle albumin-bound) technology platform. Abraxane for injectable suspension is currently marketed for breast cancer treatment. Earlier preclinical and clinical studies investigated the potential for Coroxane as an alternative to drug-eluting stents in the coronary arteries. Systemic application of Coroxane could be useful for the management of restenosis in both cardiac and peripheral vascular settings, the company stated.
Led by Principal Investigator John Rundback, MD, the phase 2 trial is a randomized, open-label, prospective, multicenter study that will compare the safety and efficacy of three different Coroxane dosing schedules to primary percutaneous balloon angioplasty with provisional stenting, the standard treatment for stenosis in the superficial femoral artery. Approximately 150 patients will be monitored for restenosis of the target vessel at 9 months as evaluated by angiography and duplex ultrasound. The study is an important step forward in providing a treatment alternative to patients with moderate- to long-segment superficial femoral artery disease using Coroxane, according to Dr. Rundback.
"The novel mode of delivery allows platform-independent treatment and can be used regardless of the initial revascularization method," commented Dr. Rundback. "Because drug-eluting stents have not yet clearly shown long-term benefit, a different strategy for delivering this very bioactive agent to the site of balloon injury has tremendous potential to expand the therapeutic options and improve outcomes for these patients."
Cook Medical Commences REFORM Clinical Trial
March 19, 2008—Cook Medical (Bloomington, IN) announced that the FDA has approved initiation of the REFORM clinical trial to evaluate the safety and effectiveness of the Formula 418 balloon-expandable stent in the treatment of renal artery atherosclerosis against well-established performance data. REFORM will enroll up to 100 patients at up to 30 investigative sites in the US. Initial results are expected to be available in the second quarter of 2010. REFORM's national Principal Investigator is Rajesh M. Dave, MD.
According to Cook Medical, the Formula 418 balloon-expandable stent is intended for the long-term treatment of patients with atherosclerotic de novo or restenotic lesions following suboptimal angioplasty. The device also features an increased number of stent crowns, improving stent circularity and may improve wall apposition of the stent to the renal artery. The Formula 418 is an investigational device and is not currently indicated for renal artery stenosis in the US, the company advised.
"I am impressed with the very low profile of the Formula stent and its ability to cross the stenosed renal arteries," commented Dr. Dave. "The stent system does not shorten and reliably opens up on both ends, which enhances my ability to place the stent more accurately. Our first patient had severely stenosed arteries within both kidneys along with severe uncontrolled hypertension but is now doing very well."
Angiotech to Market Rex Medical's Option IVC Filter
March 13, 2008—Angiotech Pharmaceuticals, Inc. (Vancouver, British Columbia) announced that it has entered into a definitive licensing agreement with Rex Medical, LP (Conshohocken, PA) for exclusive worldwide rights to market and distribute the Rex Medical's Option inferior vena cava (IVC) filter for the clinical management of pulmonary embolism (PE). The nitinol Option IVC filter is specifically designed for long-term retrieval after device implantation. It features a low-profile 5-F (6-F outer diameter) delivery system. The filter is designed with symmetric flared struts to direct clot volume into the center of the vessel for maximum dissolution and preservation of blood flow, thus allowing for the capture of clinically significant clots and protection against PE. Intended to be used as both a permanent or retrievable IVC filter, the self-centering filter promotes optimal positioning and stability within the IVC, the company stated.
According to Angiotech, the Option IVC filter is expected to receive regulatory approval for both permanent and retrievable indications. Rex Medical expects that the Option IVC filter will be commercially available in the US and EU by the end of 2008, pending regulatory approval. The Option's US clinical study enrollment is expected to be completed by the end of the second quarter of 2008. FDA filing for 510(k) approval will be completed in the near term. Rex Medical has filed for the CE Mark and is awaiting approval from the European regulatory bodies.
"I am impressed with the Option IVC filter's low-profile delivery system and novel nitinol design," commented Matthew S. Johnson, MD, lead investigator of the Option clinical trial. "Results to date suggest that it prevents PE as well as any commercially available filter. And, despite its remarkable stability, the Option has been safely and successfully retrieved at long intervals—up to 175 days in the US IDE."
Diomed Agrees to Be Sold to AngioDynamics
April 10, 2008—Diomed Holdings, Inc. (Andover, MA) announced that it has entered into an asset purchase agreement with AngioDynamics, Inc. (Queensbury, NY) for the sale of Diomed's US operations for $8 million in cash. Diomed develops and commercializes minimal and microinvasive medical procedures, including the company's EVLT endovenous laser ablation treatment for varicose veins. The assets subject to the agreement exclude the proceeds of Diomed's settlement with AngioDynamics of US patent #6,398,777, covering the endovascular treatment of varicose veins, under which AngioDynamics agreed to pay $7 million. Also excluded are the proceeds of Diomed's anticipated $3.6 million settlement with Vascular Solutions, Inc. (Minneapolis, MN), which is pending bankruptcy court approval, as well as certain patents.
On March 14, 2008, Diomed Holdings, Inc. and its wholly-owned subsidiary, Diomed, Inc. filed a voluntary petition under Chapter 11 of the US Bankruptcy Code in the US Bankruptcy Court. Since that time, Diomed has been operating as a debtor in possession while pursuing the sale of its US operating assets. Diomed expects to complete the asset sale to AngioDynamics within approximately 60 to 90 days and to sell its remaining assets in due course, subject to the approval of the bankruptcy court. The original bankruptcy petition had contemplated that Diomed would sell certain operating assets to Biolitec AG (East Longmeadow, MA), a manufacturer of medical lasers, optical fibers, and other products. Instead, the AngioDynamics transaction will be pursued.
According to Diomed, AngioDynamics has also agreed to pay $3 million in cash for certain of the assets of Diomed Ltd (Cambridge, UK), the UK subsidiary of Diomed Inc, which filed for insolvency administration under UK laws contemporaneously with Diomed's bankruptcy filing in the US. The closing of AngioDynamics' agreement with Diomed Holdings, Inc. is conditioned upon AngioDynamics' acquisition of Diomed Ltd's assets and is subject to, among other conditions, court approval and an auction process administered by the courts, under which other interested parties may present competing offers.
The asset purchase agreement contemplates that Diomed will use its existing cash, receivables, and ongoing revenues to fund its operations while it operates under Chapter 11, and, if necessary, may include up to $1.3 million in debtor-in-possession financing from AngioDynamics. The contemplated debtor-in-possession financing will also be subject to bankruptcy court approval, Diomed stated.
Medtronic Launches Xcelerant Hydro Delivery System for Talent AAA Stent Graft in Europe
March 12, 2008—Medtronic Vascular (Santa Rosa, CA) announced the European market launch of the Talent abdominal stent graft on the new Xcelerant Hydro delivery system, which features a hydrophilic coating designed to aid navigation of the device through tight and tortuous arteries by reducing friction with the artery wall. The device is intended for the endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAA).
The company noted that the Xcelerant Hydro delivery system was shown in bench testing to generate a 99% reduction in friction compared to the previous delivery system, which does not have the hydrophilic coating. The device features an integrated sheath that contributes to the system's low-profile characteristics, which are intended to enable excellent tracking and access through small vessels.
According to Medtronic, EVAR has been shown to be an effective therapy for AAAs, with fewer postoperative complications and shorter recovery times than open surgical repair. In The Lancet, Professor Roger M. Greenhalgh, MD, for the EVAR trial participants, published a UK study that the 30-day mortality rate for EVAR patients was 1.7% compared to 4.7% for patients who underwent open repair, a nearly threefold difference (2004;364:843-848). Similarly, the New England Journal of Medicine recently published results from a US study by Marc L. Schermerhorn, MD, et al indicating that perioperative mortality was significantly lower after EVAR than after open repair (1.2% vs 4.8%; a fourfold difference) (2008;358:464-474).
"The Xcelerant Hydro delivery system is a significant innovation that will make EVAR using the Talent stent graft a treatment option for more patients with abdominal aortic aneurysms," commented Dierk Scheinert, MD, PhD, the leader of the first team to implant the device using the new delivery system. "It will simplify the procedure for endovascular interventionists in treating patients whose iliac arteries are difficult to navigate when they are small and tortuous."
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| CONFERENCE COVERAGE |
Interventional Procedures Shown to Be Safe for Octogenarians
March 18, 2008—The Society of Interventional Radiology (SIR) announced that a study presented at its 33rd Annual Scientific Meeting demonstrated that seniors over the age of 80 can safely undergo diagnostic angiography and arterial interventions—such as vascular stenting and angioplasty—and do just as well as younger patients. The study indicates that seniors (aged 85–93 years) tolerated these procedures well, avoided surgery, and could be treated as outpatients regardless of age. The investigators compared the outcomes of the treatments in the octogenarians to those of patients aged 50 to 79 years who had an equivalent procedure during the same time period by the same doctor. The study included 64 octogenarians who had arterial angioplasty and/or stenting to treat peripheral arterial disease or to improve blood flow to the kidneys by opening blocked arteries that deliver blood to that organ. All were treated as outpatients and followed after discharge from the hospital. The investigators concluded that diagnostic arteriography and arterial interventions can be safely performed on octogenarians as outpatient procedures, even without the routine use of closure devices. Octogenarians seem to tolerate arteriography and arterial interventions as well as younger patients. Octogenarians do not need admission for these procedures, the investigators stated. SIR's Abstract 131 of the study, "Outpatient Arteriography and Arterial Intervention in Octogenarians: Is It Safe?" is available at www.SIRmeeting.org.
According to investigator George G. Hartnell, MD, doctors may be reluctant to send an older person for treatment in some cases. But, he said, there is no reason for seniors with leg pain caused by peripheral arterial disease to put up with pain, limited mobility, and diminished quality of life. Likewise, treating blocked renal arteries can improve kidney function and treat high blood pressure if caused by diminished renal blood flow. Previously, the risks of angiography, x-ray images of the arteries with contrast and arterial interventions, such as angioplasty and stenting, were thought to increase with age. Older seniors were even excluded from some interventional trials because of the perception that they were too frail to participate. Some physicians, both interventionists and referring physicians, incorrectly think that octogenarians requiring these procedures should be admitted to hospitals, Dr. Hartnell stated.
"What is an appropriate treatment at 55 is just as safe and appropriate at 85," commented Dr. Hartnell. "Older seniors can be treated as outpatients, and age did not increase the risk. This is very relevant because the incidence of clogged arteries increases with age, and peripheral arterial disease affects 12% to 20% of Americans aged 65 and older."
UFE Treatment Highlighted in Studies Presented at SIR
March 18, 2008—The Society of Interventional Radiology (SIR) announced that a study presented by John Lipman, MD, at its 33rd Annual Scientific Meeting shows that of 105 patients in the Atlanta metro area, only 18% of the women who saw a private practice gynecologist were told about minimally invasive uterine fibroid embolization (UFE) as a treatment option. The majority of women who sought treatment from their private practice gynecologists for uterine fibroids were only offered hysterectomy or myomectomy surgery. However, Kaiser Permanente, which standardizes many medical protocols, has its gynecologists discuss all the treatment options with their patients, including UFE. Of the women who self-referred to interventions, the majority found out about UFE on their own primarily through the Internet or through a media advertisement. In some cases, they obtained referrals from their gynecologists, but only after asking about the treatment. SIR's Abstract 143 of the study "Community Awareness of UAE as a Treatment Option for Women Suffering With Symptomatic Fibroids," can be found at www.SIRmeeting.org.
According to Dr. Lipman, the hysterectomy numbers in the US have changed very little in the past decade, despite the demonstrated long-term safety and efficacy of UFE. Notably, of all of the available treatment options for fibroids, the largest published series is the UFE National Fibroid Registry, which has published information on the UFE treatment of more than 3,000 women. The 3-year data from this trial were recently published by Scott C. Goodwin, MD, et al in Obstetrics & Gynecology (2008;111:22-33). Interventionists have consistently published in gynecology journals to increase awareness of the treatment, Dr. Lipman stated. Using MRI, they can provide second opinions and assess whether UFE is a treatment option.
"Women with fibroids need to be given all of their options—not just the ones that gynecologists can offer," commented Dr. Lipman. "Physicians need to incorporate UFE into the treatment algorithm for patients suffering with uterine fibroids. The patient should not have to be the one to suggest her treatment; that is the physician's responsibility. Gynecologists need to be the ones taking the lead on this."
Also at the SIR meeting, Alisa Suzuki, MD, presented a study showing that UFE provides significant symptom relief for women whose focused ultrasound (FUS) treatment failed. According to Dr. Suzuki, primary care physicians and gynecologists can feel confident in informing patients that a failed FUS treatment does not require subsequent gynecological surgery. Those women can be successfully treated with UFE. Patients with a single large fibroid are candidates for FUS; patients with many fibroids, which is more common, would be better treated with UFE. There are limited long-term follow-up data for FUS and limited information on fibroid recurrence rates. In this retrospective study, seven post-FUS patients who experienced therapeutic failure and were subsequently retreated with UFE were reviewed. In all patients, their symptoms—such as heavy menstrual bleeding and the sensation of fullness or pressure in the lower abdomen—improved.
FUS focuses high-frequency, high-energy sound waves to generate heat at a specific point within the fibroid tissue to shrink the fibroid and relieve symptoms. FUS has been approved by the FDA for several years, but the number of procedures performed is still limited because there are few institutions providing FUS. SIR's Abstract 142, "When Sound Fails: Efficacy of Uterine Artery Embolization for Focused Ultrasound Surgery Therapeutic Failures," can be found at the SIR Web site.
"FUS is a newer procedure for uterine fibroids and whether it provides sustained symptom relief is still being evaluated. My research shows that when FUS fails, these women could benefit from UFE," commented Dr. Suzuki. "UFE is widely available; patients can easily obtain information about this interventional radiology treatment on the Internet. Women should ask for a consult with an interventionist who can determine from MRI imaging whether they are candidates for either procedure."
Renal Artery Stenting Falls Short in ASTRAL Trial
April 1, 2008—The American College of Cardiology (ACC) and the Society for Cardiovascular Angiography and Interventions (SCAI) announced that the largest-ever randomized study to evaluate the effectiveness of catheter-based interventions in patients with narrowing of the renal artery has shown that angioplasty and stenting offer no benefit over medical therapy. Among patients who completed 1 year of follow-up, there were no differences in the change in kidney function, blood pressure control, or the rates of major cardiovascular illness, according to the Angioplasty and Stenting for Renal Artery Lesions (ASTRAL) trial. Philip A. Kalra, MD, presented findings from the ASTRAL trial reported at the SCAI Annual Scientific Sessions in Partnership with ACC i2 Summit in Chicago. The study also found that 3% of patients who underwent renal artery intervention experienced a serious procedural complication, including poorly positioned stents as well as perforation and dissection of the renal artery, the ACC and SCAI stated.
According to the ACC and SCAI, the purpose of the study was to evaluate the clinical effectiveness of renal artery stenting. The investigators recruited 806 patients with atherosclerotic renal vascular disease (ARVD) from 54 medical centers in the UK and four in Australia and New Zealand. Patients presented with renal failure, with an average serum creatinine level of approximately 2 mg/dL. Baseline blood pressure averaged 151/76 mm Hg. More than half were current or former smokers, nearly one-third had diabetes, and nearly half had coronary artery disease. The average degree of renal artery stenosis at baseline was 76%.
The investigators randomly assigned patients to catheter-based intervention plus medical therapy or medical therapy alone. Renal artery stenting was successful in widening the renal artery, achieving a residual stenosis of <50% in 88% of patients. After 1 year of follow-up, however, there were no differences in the change in serum creatinine levels (increased 0.2 mg/dL in both groups) or in rates of renal events, including acute renal failure. Even in the highest-risk patients, defined as those having a baseline creatinine level in the highest third, or who had experienced a rapid deterioration in kidney function in the preceding year—renal artery angioplasty and stenting offered no significant renal functional benefit at 1 year, but patient numbers in these subgroups were fairly small.
Blood pressure decreased slowly over time, and by 4 years, averaged 146/74 mm Hg in both groups. At 1 year, there was no significant difference in the rates of heart attack, stroke, hospitalization for chest pain, or heart failure or the need for coronary intervention or bypass surgery. The risk-adjusted mortality rate was the same in the two groups.
Dr. Kalra stated, "In this study, we were looking at the majority of patients with renal artery stenosis—those in whom there is substantial uncertainty about whether to revascularize. The message is, you don't put a stent in these patients without more careful evaluation. More often than not, it will make no difference whatsoever in clinical outcomes. However, some patients with renal artery stenosis have more definite indications for revascularization, such as acute renal failure or severe acute heart failure, and they should continue to receive this therapy."
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| LITERATURE HIGHLIGHTS |
Three-Year SAPPHIRE Data Published
April 10, 2008—The New England Journal of Medicine has published the 3-year results of the SAPPHIRE (Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy) study by Hitinder S. Gurm, MD, et al (2008;358:1572-1579). The SAPPHIRE investigators concluded that, in this trial of patients with severe carotid artery stenosis and increased surgical risk, no significant difference could be shown in long-term outcomes between patients who underwent carotid artery stenting (CAS) with an embolic protection device and those who underwent carotid endarterectomy (CEA). The SAPPHIRE trial, sponsored by Cordis Corporation (Warren, NJ), specifically studied Cordis's Precise nitinol carotid stent and delivery systems (5.5 F and 7 F) with the company's Angioguard XP distal protective embolic capture guidewire.
According to the investigators, the randomized trial evaluated CAS with the use of an embolic protection device as compared with CEA in 334 patients at increased risk for complications from CEA who had either a symptomatic carotid artery stenosis of ≥50% of the luminal diameter or an asymptomatic stenosis of ≥80%. The prespecified major secondary endpoint at 3 years was a composite of death, stroke, or myocardial infarction within 30 days after the procedure or death or ipsilateral stroke between 31 days and 1,080 days (3 years). Three-year data were available for 260 patients (77.8%), including 85.6% of patients in the CAS group and 70.1% of patients in the CEA group. The prespecified major secondary endpoint occurred in 41 patients in the CAS group (cumulative incidence, 24.6%; Kaplan-Meier estimate, 26.2%) and 45 patients in the CEA group (cumulative incidence, 26.9%; Kaplan-Meier estimate, 30.3%) (absolute difference in cumulative incidence for the stenting group, -2.3%; 95% confidence interval, -11.8 to 7). There were 15 strokes in each of the two groups, of which 11 in the CAS group and nine in the CEA group were ipsilateral, the investigators reported.
TEVAR Compared to Surgery for Traumatic Aortic Injury
April 1, 2008—In the Journal of Vascular and Interventional Radiology, Richard Owen, MD, et al published findings from a comparison of immediate and midterm outcomes of open surgical repair versus thoracic endovascular repair (TEVAR) of traumatic thoracic aortic injuries (2008;19:479-486). Health records were used to identify patients with traumatic injury presenting between April 1995 and September 2006. Preoperative patient characteristics, intraoperative variables, procedural costs, and outcomes were recorded. The investigators concluded that TEVAR of traumatic thoracic aortic injury is associated with lower perioperative mortality and morbidity rates than open surgical repair, with no significant graft-related complications on midterm follow-up. The study data support the continued use of TEVAR in this context, the investigators stated.
As reported in the article, the investigators identified 103 patients with traumatic thoracic aortic injury, of whom 22 died before treatment, 19 were treated conservatively, 36 received open surgical repair, and 26 received TEVAR. In the open surgical group, time from diagnosis to treatment was 8 hours, the 30-day mortality rate was 11.1%, and all deaths occurred intraoperatively. Thoracic nerve injury occurred in four patients (12.5%), pneumonia in 12 (37.5%), temporary renal failure in one (3%), paraparesis in three (9.4%), and paraplegia in five (15.6%). On follow-up (mean, 61 months), postthoracotomy pleural reaction was seen in three cases (9.4%). In the TEVAR group, time to treatment was 38 hours (P<.01), and the 30-day mortality rate was 7.4% with no intraoperative deaths. Pneumonia was seen in two cases (8.3%), and left arm ischemia was seen in two of 17 patients in whom the left subclavian artery was covered. On midterm follow-up (mean, 17 months), there were no graft failures or repeat aortic interventions. Costs of each procedure were initially comparable, but follow-up expenses with TEVAR were Can $1,284 more per year.
High ABI Associated With Increased Mortality, Decreased QOL
April 1, 2008—A study of peripheral arterial disease (PAD) published by Matthew A. Allison, MD, et al in the Journal of the American College of Cardiology sought to determine if an ankle-brachial index (ABI) ≥1.4 is associated with reduced quality of life (QOL) (2008;51:1292-1298). ABI values of ≥1.4 have been associated with some cardiovascular disease (CVD) risk factors and increased mortality, but the relationship to other disease morbidity, such as reduced QOL, has not been previously evaluated, the investigators stated.
As detailed by the investigators, the PARTNERS (PAD Awareness, Risk and Treatment: New Resources for Survival) program was a national cross-sectional study of 7,155 patients aged >50 years recruited from 350 primary care sites. All sites performed the ABI using a Doppler device and a standardized technique. A total of 296 subjects had an ABI ≥1.4 in at least one leg, and 4,420 had an ABI between 0.9 and 1.4. Diabetes, male gender, and waist circumference were positively associated with a high ABI, and smoking and dyslipidemia were inversely associated with a high ABI. After adjustment for age, gender, and the traditional CVD risk factors and accounting for multiple comparisons, the high ABI group had significantly higher odds for foot ulcers (P<.005) and borderline associations with heart failure, stroke, and neuropathy. After the same adjustments and adjusting for patients with other CVD, the high ABI group scored two points lower on the physical component scale on the Medical Outcomes Study Standard Form-36 and 5.5 points lower on the Walking Impairment Questionnaire walking distance domain (P<.05 for both). Individuals with a high ABI have increased odds for foot ulcers and neuropathy, as well as lower scores on some physical functioning QOL domains, the investigators concluded in the article.
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