EVToday News
| REGULATORY UPDATE |
Cook Medical's Zenith TX2 TEVAR Graft Approved by FDA
May 23, 2008—Cook Medical (Bloomington, IN) announced it has received FDA approval for its Zenith TX2 thoracic aortic aneurysm (TAA) endovascular graft. The Zenith TX2 is indicated to treat patients with aneurysms or ulcers of the descending thoracic aorta having vascular morphology suitable for endovascular repair (TEVAR). Approval for the device indication was based on the 12-month results of Cook's multinational STARZ-TX2 clinical trial, the results of which indicated that TEVAR with the Zenith TX2 is a safe and effective alternative to open surgical repair for the treatment of TAAs in patients with suitable anatomy. The Cook Zenith TX2 includes an uncovered distal stent with fixation barbs to hold the device in place. The device relieves pressure on the aneurysm, reduces the risk of rupture, and in most cases, allows the aneurysmal sac to shrink, the company stated.
FDA Clears GE's LightSpeed CT750 HD Scanner
May 13, 2008—GE Healthcare (Wauwatosa, WI) announced FDA clearance of its high-definition computed tomography (CT) scanner, the LightSpeed CT750 HD, which incorporates GE's Gemstone Detector and Gemstone Spectral Imaging. According to GE, the company found that by changing the molecular structure of garnets, it could develop a scintillator capable of delivering images 100 times faster, with up to 33% greater detail through the body and up to 47% greater detail in the heart than previous-generation scanners. The device's Gemstone Spectral Imaging uses up to 2,496 views per rotation to deliver improved spatial resolution and improved image quality across the entire field of view. Dual-energy fast kV switching registers energies at least 165 times faster than dual-source CT at a .33-second rotation speed. It offers 128 slices of unique data per rotation and 101 user-selectable energy levels for viewing. The faster, clearer images are achieved without sacrificing radiation dose reduction. The CT750 HD improves image quality while reducing dose by up to 50% across the entire body and by as much as 83% for cardiac scans. Additionally, the CT750 HD's improved spatial resolution allows it to reduce calcium blooming artifacts, making accurate stenosis quantification possible. In bench testing, it was able to accurately measure 75% stenosis on a 3-mm vessel within 100 µm, and it showed improvement in low-contrast detection of 40% over the previous release, the company stated.
FDA Approves Medtronic's Talent Thoracic Stent Graft
June 5, 2008—Medtronic Vascular (Santa Rosa, CA) announced FDA approval for the Talent thoracic stent graft for the endovascular repair of aneurysms of the descending thoracic aorta. With a range of 22-mm to 46-mm diameters, the device makes thoracic endovascular aortic repair (TEVAR) accessible to an additional 25% of patients and offers interventionists multiple options to customize devices to the needs of patients and a wider range of anatomies. Ronald Fairman, MD, was Principal Investigator of the Medtronic-sponsored VALOR (Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms) clinical trial.
According to Medtronic, 195 patients were enrolled in the VALOR trial at 38 medical centers between December 2003 and June 2005. All 195 patients received a Talent thoracic stent graft, and their outcomes were compared to 189 open surgical control patients at three centers of excellence who matched selected inclusion/exclusion criteria of the VALOR trial. The Talent group met its primary safety and efficacy endpoints, with an all-cause mortality rate of 16.1% and a successful aneurysm treatment rate of 89.2% at 12 months. In the VALOR trial, the 30-day mortality rate was 2.1%, and the aneurysm-related mortality rate at 12 months was 3.1%. The VALOR data show that TEVAR with the Talent thoracic system resulted in lower mortality than open surgery, as well as low rates of morbidity and device-related adverse events, the company stated.
Gore's TAG Endoprosthesis Approved in Japan for TEVAR
June 5, 2008—Gore & Associates, Inc. (Flagstaff, AZ) announced that it has received regulatory clearance from the Japanese Ministry of Health, Labor, and Welfare to market the Gore TAG thoracic endoprosthesis for the treatment of aneurysms of the descending thoracic aorta. The first postapproval procedure using the device in Japan was conducted by Toru Kuratani, MD, at Osaka University who was supported by Takao Ohki, MD, who has a significant amount of experience with the device. The 1-hour procedure went very smoothly, the company said.
The company noted that the Gore TAG was designated as the highest priority device for expedited regulatory review by the various physician societies in Japan. In the US, the Gore TAG was approved in March 2005. In January 2007, the company received regulatory clearance to market the Gore Excluder AAA endoprosthesis in Japan for the endovascular treatment of abdominal aortic aneurysms.
According to Gore, the TAG device is an extremely flexible ePTFE graft with an outer self-expanding nitinol support structure. In the Gore TAG's pivotal study comparing the device to open surgical repair, patients treated with the endoprosthesis experienced fewer complications, significantly less procedural blood loss, shortened hospital stays, and a two times faster return to normal activity than those treated with open surgery. Through 5 years of follow-up, patients treated with the Gore TAG device experienced a significantly lower incidence of major adverse events and improved aneurysm-related survival than patients treated with open surgery, the company stated.
St. Jude Medical's Strada and TigerWire Approved
June 4, 2008—St. Jude Medical, Inc. (St. Paul, MN) announced CE Mark approval and the European launch of the TigerWire steerable guidewire for use in peripheral arteries. The TigerWire guidewire's tip is designed with enhanced flexibility and distinct zones of flexibility to track and position the guidewire through challenging vessels. The US launch of the TigerWire as part of St. Jude's GuideRight product line was announced on April 30.
On May 7, the company announced FDA clearance and European CE Mark approval of the Strada carotid guiding sheath. St. Jude noted that the Strada's five distinct transition zones provide flexibility on the distal end of the sheath, support on the proximal end of the sheath, and kink resistance for navigating challenging anatomy. The device is available in 80-cm and 90-cm lengths.
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| INDUSTRY NEWS |
Kensey Nash's Endovascular Business Sold to Spectranetics
June 2, 2008—Spectranetics Corporation (Colorado Springs, CO) announced it has completed the closing of the transaction to acquire the endovascular business of Kensey Nash Corporation (Exton, PA) and has begun commercialization of the acquired products. The products acquired are the QuickCat thrombus aspiration catheter, the ThromCat thrombectomy device, and the SafeCross products used to treat chronic total occlusions. The companies announced their agreement to the transaction on May 13. Under the terms of the agreement, Kensey Nash will manufacture the ThromCat and SafeCross products for Spectranetics for an initial 3-year period and will manufacture the QuickCat for a minimum of 6 months.
Spectranetics will be exclusively responsible for global sales and marketing of all endovascular products. Kensey Nash will receive up to $24 million in cash upon closing and the achievement of certain product development and sales milestones as well as royalties on future sales of the ThromCat and SafeCross when product manufacturing is transferred to Spectranetics. There will be no royalty payments related to future sales of the QuickCat product. The transaction, which is subject to customary closing conditions, is expected to close by June 30, 2008, the company stated.
Covidien Acquires Pinyons' Specialty Injection Devices
May 14, 2008—Covidien Ltd. (St. Louis, MO) announced that it has signed an agreement with Pinyons Medical Technology Inc. (Park City, UT) to acquire all assets related to the Pinyons PowrSyringe Injector and PowrSyringe Monitor handheld, manual injection, and inflation devices. These devices facilitate manual x-ray contrast media injections during angiography procedures performed in the cardiac catheterization laboratory and interventional radiology suite. Under the terms of the agreement, Covidien immediately obtains all assets related to these two Pinyons product lines, including all intellectual property, current and future product designs, and regulatory filings and approvals. The injection and inflation devices have received FDA clearance. The Medical Device Manufacturers Association awarded the Pinyons injector a 2008 Medical Design Excellence Award, the company noted.
Volcano Acquires Novelis
May 19, 2008—Volcano Corporation (San Diego, CA) announced that it has acquired Novelis, Inc. (Methuen, MA), a privately held company with proprietary ultrasonic visualization and therapy technology for minimally invasive diagnostic and therapeutic devices. Under the terms of the agreement, Volcano paid approximately $12 million in cash at closing, with an additional $3 million due on the achievement of specific regulatory milestones.
According to Volcano, Novelis's core product line is based on its Forward-Looking Intravascular Ultrasound (FLIVUS) technology. Novelis products include an image-guided crossing catheter that combines visualization, steerability, and radiofrequency tissue ablation to safely cross chronic total occlusions in the coronary and peripheral arteries, and an imaging-only FLIVUS catheter to facilitate current guidewire-based chronic total occlusion crossing techniques. The company expects to file for US and international regulatory approvals on the first of several devices during 2009 and begin commercialization of a stand-alone imaging console in the second half of 2009 in the US and Europe. Novelis's FLIVUS technology platform is expected to build upon Volcano's existing suite of products, including its s5i multimodality integrated platform/hub, the company stated.
Cook Announces FIM Use of Zenith Low Profile Endograft
June 3, 2008—Cook Medical (Bloomington, IN) announced the first-in-man use of the company's Zenith Low Profile AAA endograft system for the treatment of abdominal aortic aneurysms. The radically smaller system has been simplified to eliminate the top cap and uses more highly compressible Z-stent bodies instead of the existing stents used in the current Zenith Flex endografts and features a 16-F delivery sheath. If proven safe and effective in an upcoming clinical trial, Cook's miniaturized device could open endovascular treatment of aneurysms to a new class of patients who currently have only open surgery as a treatment option due to the small diameter of their blood vessels and other anatomic issues. In addition, it may enable physicians to eliminate the need for a surgical cutdown to access the femoral artery and allow the use of the percutaneous entry technique with less trauma, the company stated.
AngioDynamics' Purchase of Diomed Approved by Court
June 4, 2008—AngioDynamics, Inc. (Queensbury, NY) announced today that the US Bankruptcy Court has granted an order approving AngioDynamics' purchase of certain US assets of Diomed Holdings (Andover, MA) and its wholly owned subsidiary, Diomed, Inc. The sale conditions are set forth in a definitive asset purchase agreement, whereby AngioDynamics has agreed to pay $8 million in cash for the US assets and $3 million in cash for certain UK assets of Diomed Limited. The company expects to close the purchase of both the US and UK assets on or about June 16, 2008. The planned acquisitions, announced on April 10, were subject to an auction process administered by the bankruptcy court as a result of Diomed's Chapter 11 bankruptcy proceedings. Diomed manufactures and sells EVLT, its endovenous laser treatment, for varicose veins.
On June 3, AngioDynamics, VNUS Medical Technologies, Inc. (San Jose, CA), and Vascular Solutions (Minneapolis, MN) announced the settlement and resolution of the patent infringement lawsuit between the companies filed in 2005. Under the terms of the agreement, VNUS grants to AngioDynamics and Vascular Solutions, a nonexclusive, nonsublicensable patent license that covers certain products such as disposable endovenous laser fiber kits, laser fibers, and lasers used in the practice of endovenous laser ablation. The licensees, AngioDynamics and Vascular Solutions, stipulated that the VNUS patents-in-suit are valid, enforceable, and were infringed by the licensees. The license requires per-unit royalty payments for AngioDynamics' NeverTough Vena-Cure products and Vascular Solutions' Vare-Lase endovenous laser products sold or shipped in the US until September 11, 2017 and have agreed to an up front payment of $6.8 and $3.1 million, respectively for past infringement of the VNUS.
According to the companies, all litigation between the three parties will be dismissed. The patent infringement lawsuit brought by VNUS against its three endovenous laser competitors, Diomed, AngioDynamics, and Vascular Solutions, had been scheduled to go to trial on June 23 but was stayed due to Diomed's bankruptcy filing. VNUS stated that it plans to file a claim against the Diomed estate for monetary damages attributable to Diomed's alleged past and current infringement of VNUS patents.
Sirtex's Microspheres Studied in Chemotherapy Trials
May 21, 2008—Sirtex Medical Inc. (Wilmington, MA) announced plans for SIRFLOX, an international clinical study evaluating the safety and efficacy of the company's SIR-Spheres yttrium-90 microspheres when administered with the chemotherapy regimen FOLFOX6 (folinic acid, fluorouracil, oxaliplatic) as a first-line therapy in patients with nonresectable colorectal liver metastases compared to chemotherapy alone. The study's principal investigators are Australian oncologists Peter Gibbs, MD, and Guy Van Hazel, MD. The SIRFLOX study will enroll 318 patients at 25 to 35 sites in Australia, New Zealand, the US, and the EU. The primary endpoint is progression-free survival. In the US, the trial will be conducted under an FDA-approved protocol via an investigational device exemption.
According to the company, only a small number of patients meet eligibility criteria for the available treatment options for colorectal liver metastases. Sirtex Medical's SIR-Spheres microspheres are indicated for use in patients with advanced liver tumors when other treatments cannot be used. SIR-Spheres microspheres are indicated for the treatment of nonresectable metastatic colorectal cancer in combination with intra-arterial floxuridine (FUDR, distributed by Faulding Pharmaceutical Co., Paramus, NJ; manufactured by Mayne Pharma Pty. Ltd., Mulgrave, Vic, Australia) chemotherapy. By combining SIR-Spheres microspheres with FOLFOX6 early in the treatment process, the study's goal is to document an improvement in survival time and patient quality of life. Study participants must be 18 years or older and have histological or radiological evidence of liver metastases of the colon or rectum. Patients must also have a life expectancy of at least 3 months without active treatment. After randomization, patients will receive either systemic FOLFOX6 chemotherapy or a combination of FOLFOX6 with SIR-Spheres microspheres. In addition to progression-free survival, study outcomes will be determined by evaluating tumor response rate, toxicity and safety, overall survival, and quality of life.
The company stated that selective internal radiation therapy (SIRT) is a novel treatment for inoperable liver cancer that delivers high doses of radiation directly to the site of tumors. In this minimally invasive SIRT treatment, millions of radioactive SIR-Spheres microspheres are infused via a catheter into the liver where they selectively target liver tumors with a dose of internal radiation up to 40 times higher than conventional radiotherapy while sparing healthy tissue. Clinical trials have confirmed that liver cancer patients treated with SIR-Spheres microspheres have response rates higher than with other forms of treatment, resulting in increased life expectancy, greater periods without tumor activity, and improved quality of life. SIRT has been found to shrink liver tumors more than chemotherapy alone. SIR-Spheres microspheres are approved for use in Australia, the US, and the EU.
On May 14, Sirtex announced the launch of a clinical trial evaluating the effect of treatment with SIR-Spheres microspheres on the survival of patients with unresectable hepatocellular carcinoma (HCC). Interventional radiologist Ravi Murthy, MD, and surgical oncologist T. Clark Gamblin, MD, will serve as coordinating investigators for the study. Sirtex received an FDA investigational device exemption to conduct the trial. The trial is actively recruiting patients at Thomas Jefferson University's Kimmel Cancer Center in Philadelphia, and the company expects to open patient recruitment at additional sites in the coming months. The study will enroll 40 patients over a period of 24 months. Eligible patients must be 18 years or older and have documented HCC disease confined to the liver. The primary objective of the study is to evaluate the effect of SIR-Spheres microspheres on survival rates in patients with HCC. The trial will also assess treatment safety, time-to-disease progression, health-related quality of life, and tumor response to treatment.
According to the company, SIRT using SIR-Spheres yttrium-90 microspheres has been reported in a number of nonrandomized trials to be effective and well tolerated in patients with unresectable HCC, one of the leading causes of cancer-related mortality worldwide. Surgery is the most effective treatment option; however, 90% of patients with HCC have tumors that cannot be surgically removed. Although SIR-Spheres microspheres have been used extensively in other parts of the world for the treatment of HCC, in the US, there is no FDA-approved microsphere therapy for this type of tumor. The aim of this study is to further evaluate the safety and efficacy of microsphere therapy in patients with HCC, the company stated.
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| CONFERENCE COVERAGE |
Large Study Shows Higher Risks for CAS Versus CEA
June 5, 2008—At the Vascular Annual Meeting in San Diego, California, Mohammad H. Eslami, MD, presented a study that compared discharge data from patients who had carotid artery stenting (CAS) or carotid endarterectomy (CEA) in 2005. The investigators noted that CAS patients had a much higher risk of postoperative stroke; a fivefold higher in-hospital mortality rate; and increased hospital charges, especially for those patients who had symptomatic carotid stenosis.
For the study, investigators reviewed discharge records of approximately 124,000 patients in the US with a mean age of 71 years. Of these patients, 91% underwent CEA and 9% underwent CAS. For symptomatic patients, the comparative in-hospital mortality rates were significantly different (1.3% for CEA vs 5.2% for CAS). For asymptomatic patients, in-hospital mortality rates were not significantly different (.25% for CEA and .33% for CAS). Postoperative stroke rates were significantly different in the asymptomatic patients (.91% for CEA vs 1.58% for CAS) but not significantly different in the symptomatic patients, although the trend was the same (1.84% for CEA vs 2.52% for CAS).
Multivariate logistic regression was performed to evaluate independent predictors of postoperative stroke and mortality and showed that CAS was independently predictive of increased mortality. Overall length of stay was significantly lower for asymptomatic CAS patients, but it was significantly higher for symptomatic CAS patients (5.4 days for CEA vs 6.8 days for CAS). Mean overall charges for hospital stays were $22,800 for CEA versus $35,000 for CAS. For asymptomatic patients, mean costs were $21,700 for CEA and $32,400 for CAS. Costs for symptomatic patients were $37,000 for CEA and $63,800 for CAS, a significant difference.
"Before this study, no specific ICD-9 procedure code was available for CAS, making it difficult to examine outcomes at the national level," commented Dr. Eslami. "The role of CAS in the management of asymptomatic and symptomatic carotid artery stenosis remains uncertain due in part to conflicting results from relatively small clinical studies."
Although the current research included a large representative sample, the study could not control for case severity. However, Dr. Eslami stated that the magnitude of the higher stroke and mortality rates after CAS as currently performed in the US is disturbing. If these results, including hospital charges, are verified in another large US database, a reappraisal of the use of CAS in the US would be warranted, he asserted. Studies such as this one, he said, should increase caution about CAS as an equal alternative to CEA, but it should not be viewed as an indictment of CAS.
"As an endovascular surgeon who performs CAS based on Centers for Medicare and Medicaid Services guidelines," added Dr. Eslami, "I believe that CAS should currently be viewed as an extension of therapy available for patients with symptomatic carotid stenosis and not as a replacement. Large multicenter prospective studies eventually will define the rule of CAS in the treatment of patients with carotid stenosis."
CAS Training and Mentoring Program Established by SVS
June 6, 2008—At the Vascular Annual Meeting in San Diego, California, the Society for Vascular Surgery (SVS) announced the establishment of the Carotid Artery Stenting Training and Mentoring Program, which is designed for interventionists who want to develop or expand their expertise in carotid arterial interventions. The program provides quality education and hands-on skills in carotid arterial procedures under the instruction of expert faculty. It is specifically designed for interventionists who are credentialed to perform endovascular procedures and have some cerebral angiography experience, but minimal carotid artery stenting experience. The goal of the program is to maintain the highest standards of care for patients with carotid artery disease by ensuring that well-qualified surgeons pursue a rigorous course of training in CAS leading to the achievement of specific training goals. The SVS's Carotid Artery Stenting Training and Mentoring Program is supported by an educational grant from the Cordis Cardiac & Vascular Institute, which was established in 2006 by Cordis Corporation (Warren, NJ) to provide physicians and other health care providers with educational and clinical resources for the advancement of the understanding and treatment of a broad range of cardiac and vascular conditions, including coronary artery disease and stroke, the SVS stated.
Infrainguinal Bypass Surgery Has Significant Morbidity
June 5, 2008—At the Vascular Annual Meeting in San Diego, California, Glenn LaMuraglia, MD, presented findings from a new database and early outcomes study indicating that a number of clinical and anatomic factors influence the decision between infrainguinal bypass surgeries (BPG) and endovascular procedures used to treat lower extremity vascular disease. The National Surgical Quality Improvement Program provided statistics for 2,404 BPGs (42% infrapopliteal distal anastomosis; 29% prosthetic). An analysis was performed from this detailed major morbidity and mortality database derived from multiple private sector hospitals around the country. The study investigators at Massachusetts General Hospital in Boston reinforced the precept that stringent indications for BPG should be maintained. When clinically and anatomically feasible, endovascular procedures should be considered as the initial therapy for infrainguinal arterial reconstruction because they have been previously reported to carry lower complication rates. Dr. LaMuraglia noted that the decision to use BPG and endovascular procedures to treat lower-extremity vascular disease is partly dependent on periprocedural outcomes. These results help place the morbidity of lower extremity bypass surgery in the proper perspective.
Dr. LaMuraglia reported that the study patients ranged in age from 66 to 69 years, 66% were male, 44% had diabetes, and the indication for surgery was limb salvage in 48%. The 30-day composite mortality/major morbidity rate was 19.5%. The overall mortality rate was 2.7% and correlated with patient age, weight, significant dyspnea, dialysis, history of transient ischemic attacks, and bleeding disorders.
The investigators found that major complications occurred in 18.7% of the patients, including 7.4% graft thromboses and 11.7% wound infections. Major systemic complications occurred in 5.9% and correlated to age, history of myocardial infarctions, dialysis, impaired sensorium, and general anesthesia. Major operative site-related complications occurred in 15.1% and correlated to a history of chronic obstructive pulmonary disease, limb salvage, impaired sensorium, nonindependent preoperative functional status, and operative time.
"Our study shows that infrainguinal BPG carries with it a nontrivial complication rate, which we need to fully appreciate," commented Dr. LaMuraglia. "The results of this study, which delineates the systemic and the local surgical complications, should assist us in taking better care of our patients with lower extremity ischemia."
EVAR of Ruptured Thoracic Aneurysms Reduces Mortality
June 5, 2008—At the Vascular Annual Meeting in San Diego, California, a study of endovascular repair of ruptured thoracic aortic aneurysms (r-TAAs) was associated with markedly reduced mortality and improved midterm survival, when compared to open surgical approach in a prospective intent-to-treat longitudinal study. Treatment and postoperative care, surgical repair of r-TAAs has continued to have a high morbidity and mortality rates despite improvements in perioperative diagnosis.
Manish Mehta, MD, presented findings of a study of 121 patients who presented emergently with r-TAAs since 2001 at The Vascular Institute for Health and Disease at Albany Medical Center. Of these patients, 43% underwent emergent thoracic endovascular aneurysm repair (TEVAR), and 57% had emergent open surgical repair. Compared to the open surgical group, the endovascular patients had significantly higher pre-existing defined comorbidities, including coronary artery disease (47% vs 17%), hypertension (69% vs 30%), chronic obstructive pulmonary disease (21% vs 4%), and chronic renal insufficiency (16% vs 4%). Neurological complications, including paraplegia and stroke, occurred more frequently in the open group (16% vs 5%). Over a mean follow-up of 15 months, 11% of the patients in the endovascular group and 16% of the patients in the open surgical group required secondary adjunctive procedures.
According to Dr. Mehta, use of endovascular techniques for emergent treatment of r-TAA increased annually from 29% in 2005 to 67% in 2006, and up to 90% in 2007. Before 2005, open surgical repair of r-TAA was the primary treatment of choice. The surgeons at the Vascular Institute for Health and Disease stated that the ability to treat r-TAA by endovascular means has had a significant impact on improving patient survival.
"The life table analysis indicated the cumulative survival in the endovascular group to be significantly better than the open surgical group at 30 days (71% vs 44%), at 1 year (51% vs 33%), at 2 years (45% vs 33%), and at 3 years (45% vs 26%)," observed Dr. Mehta. "Besides improving on the morbidity and mortality of these complex high-risk procedures, with an endovascular approach, we can expand on offering this treatment to patients with significant comorbidities who might otherwise be left untreated."
EVAR Approval Resulted in Decrease of Total AAA Deaths
June 5, 2008—At the Vascular Annual Meeting in San Diego, California, Kristina Giles, MD, reported that, in the US population, deaths from all abdominal aortic aneurysms (AAAs) as well as the total number of ruptured AAAs is declining, whereas the number of elective repairs is increasing. The findings were based on an analysis of nationwide database of hospital discharges from 1988–2005 conducted by Marc Schermerhorn, MD, and colleagues at Beth Israel Deaconess Medical Center in Boston. The database used in this study represented a 20% sample of national nonfederal hospital admissions (with sample weights allowing extrapolation to 100%) and the decreased mortality rates support the benefit of EVAR rather than open surgery in suitable patients. Dr. Schermerhorn noted before the meeting that these improved results coincide with the introduction of endovascular aneurysm repair (EVAR), approved by the FDA in 1999.
According to the investigators, during the last 17 years, the average number of elective repairs performed annually has increased from 34,147 to 35,744. Conversely, the overall annual number of ruptures of AAAs decreased from 9,662 before the approval of EVAR to 7,017 after the approval of EVAR, and rupture repairs decreased from 6,607 to 4,617.
The investigators calculated the deaths from elective repair, ruptured repair, and ruptured aneurysms without repair. The overall annual number of aneurysm-related deaths was 6,741 before the approval of EVAR (1988–1999) and 4,640 after the approval of EVAR (2000–2005). Patient mortality during the endovascular era decreased from 5,309 in 2000 to 3,949 in 2005. The average death rate after rupture repair dropped from 45% before the approval of EVAR to 41% after the approval of EVAR.
After the approval of EVAR, the average number of annual deaths in each classification decreased as follows: elective AAA repair, from 1,598 to 1,136; ruptured AAA repair, from 2,978 to 1,875; and ruptured AAA without repair, from 2,238 to 1,629. Additionally, the overall mortality rate with elective repair has decreased after EVAR was introduced, from 4.7% to 3.2%, with an average mortality rate with EVAR of 1.4%. By comparison, the mortality rate of standard open surgical elective repair was 4.7% and declined to 4.5% after the approval of EVAR, the investigators noted.
SVS's National Carotid Outcomes Registry Presented
June 6, 2008—At the Vascular Annual Meeting in San Diego, California, the Society for Vascular Surgery (SVS) announced that its Outcomes Committee presented current data from the SVS Vascular Registry on Carotid Procedures. The registry was developed by SVS in response to the Centers for Medicare and Medicaid Services' (CMS) National Coverage Decision (NCD) on carotid artery stenting (CAS). The NCD requires institutions that are performing this procedure to provide data points that include mortality and major vascular complications rates. Although CMS requires data submission only on CAS, SVS designed the Vascular Registry to collect similar data on carotid endarterectomy (CEA) to allow comparison of outcomes, with potential for expansion to other procedures.
According to Anton N. Sidawy, MD, Vice President of the SVS and member of the SVS Vascular Registry Outcomes Committee, the registry is on-line. It offers provider-reported data including preprocedure demographics, medical history, symptom status, diagnostic imaging, procedural information, complications, and follow-up. An independent data center maintains the database, which is HIPAA-compliant and auditable. Both CAS and CEA providers from seven specialties contribute data to the registry. Electronic data entry began July 11, 2005. Currently, there are discharge data on 6,403 procedures that have been entered by 287 providers at 56 centers on 2,763 CAS patients (1,450 with 30-day outcomes, 52.5%) and 3,259 CEA patients (1,368 with 30-day outcomes, 42%).
Of the total cohort, 98% of CEA and 70.7% of CAS procedures were performed for atherosclerotic disease. Of the CAS procedures, 22.3% were performed for restenosis and 4.5% were performed for radiation-induced stenosis. Of the CAS procedures, 49.2% were performed for symptomatic disease, whereas 42.4% of CEAs were performed for symptomatic disease.
The CAS patients had a higher prevalence of preprocedure stroke, amaurosis fugax, coronary artery disease, myocardial infarction (MI), congestive heart failure, chronic obstructive pulmonary disease, and cardiac arrhythmia. For CAS, the death/stroke/MI rates at 30 days were 7.13% for symptomatic patients and 4.6% for asymptomatic patients. For CEA, the death/stroke/MI rates at 30 days were 3.75% in symptomatic patients and 1.97% in asymptomatic patients. After risk adjustment for age, history of stroke, diabetes, and ASA grade (ie, significant confounders in outcomes using backward elimination), logistic regression analysis demonstrated better outcomes after CEA.
"The SVS Vascular Registry provides an excellent venue for collection of CAS data to meet CMS facility recertification requirements," commented Dr. Sidawy. "With continued enrollment and follow-up, analysis of the SVS Registry will supplement randomized trials by providing real-world comparisons of CAS and CEA with sufficient numbers to serve as an outcome assessment tool of important patient subsets and across the spectrum of peripheral vascular procedures."
SVS and ABS Agree on Certification Standards
May 12, 2008—The Society for Vascular Surgery (SVS) and the American Board of Surgery (ABS) released a joint statement regarding vascular surgery training and certification. According to the organizations, the leadership of the SVS has been focusing since its 2007 annual meeting on the continuing development of the primary certificate in vascular surgery and the evolution of vascular surgery as a separate specialty, independent of general surgery. The SVS then developed a series of issues that it requested the ABS to address. At a December meeting of the leadership of the SVS and ABS, agreements on these issues were reached that were subsequently approved at the ABS January board meeting.
Among these issues were the recognition that with the dramatic change in the nature of vascular surgery during the last 10 years and the increased role of endovascular technologies, general surgery residents are no longer trained to treat the full spectrum of arterial vascular disease. Therefore, the SVS-ABS stated that vascular surgery fellowship training is now essential for finishing residents who wish to practice in this area. The other issues can be found on SVS's vascularweb.org Web site, which has posted the complete document "SVS and ABS Joint Statement on Vascular Surgery Training and Certification."
CRF to Collaborate on ACC.i2 and SCAI Presents 2009 Plans
May 28, 2008—The American College of Cardiology (ACC) and the Cardiovascular Research Foundation have announced a 5-year partnership to jointly sponsor the ACC.i2 interventional cardiology meeting. The ACC.i2 is held in conjunction with the ACC's Annual Scientific Session. The collaboration will begin with the ACC.09 meeting in Orlando, Florida, on March 28 to 31, 2009. Additional details about the meeting will be announced in the coming weeks online at www.acc.org and www.crf.org.
On May 15, the Society for Cardiovascular Angiography and Interventions (SCAI) announced that it will hold its 2009 Annual Scientific Sessions on May 6 to 9, 2009, at Caesar's Palace, Las Vegas, Nevada. The meeting will move to a late February or early March meeting time beginning in 2010. SCAI past president Ted Feldman, MD, will chair the 2009 meeting. Additional meeting details will be announced in the coming weeks and will be available online at www.scai.org. SCAI and the ACC announced on April 25 they would return to the traditional individual meeting formats for the SCAI Annual Scientific Sessions and the ACC.i2 Summit in 2009. In 2008, the SCAI meeting was partnered with the ACC.i2 Summit during the ACC's annual meeting in Chicago at the end of March.
SCAI's Stroke Intervention Training Program Launched
June 3, 2008—The Society for Cardiovascular Angiography and Interventions (SCAI) announced that the launch of an interactive, simulation-based, stroke intervention course, "SCAI Core Curriculum in Introductory Neuro Rescue." The program, developed for cardiologists already experienced in coronary and carotid artery stenting, introduces physicians to acute stroke intervention and provides hands-on simulation in clot removal. Each session is limited to 20 experienced interventional cardiologists in order to provide extensive hands-on training, allowing participants to practice removing clots from the brain on a unique simulation system. Clots are removed using a newly FDA-approved catheter-based clot-retrieval device. SCAI's new patient and physician education program, Seconds Count, offers comprehensive information about cardiovascular disease.
SCAI Secretary and Program/Course Director Christopher U. Cates, MD, explained that course participants practiced removing a clot from the brain in the cardiac catheterization lab under the simulated circumstances that match what they would experience while treating a stroke patient. SCAI Past President Bonnie H. Weiner, MD, noted that as the procedure evolves, SCAI will also work with other societies and agencies to assess the effectiveness of these interventions against existing benchmarks for the treatment of stroke. More information about the Seconds Count program is available online at www.scai.org or www.seconds-count.org.
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| LITERATURE HIGHLIGHTS |
CABERNET's 1-Year Results Published for NexStent
June 1, 2008—One-year results from the CABERNET (Carotid Artery Revascularization Using the Boston Scientific EPI Filter Wire EZ and the EndoTex NexStent) trial were published by L. Nelson Hopkins, MD, et al in Catheterization and Cardiac Interventions (2008;71:950-960). An accompanying editorial by Issam D. Moussa, MD, considers the implications of the data (2008;71:961-962).
According to the investigators, the multicenter, single-arm CABERNET trial evaluated outcomes in high-surgical-risk patients with carotid artery stenosis treated with the NexStent (EndoTex Interventional Systems, Cupertino, CA; acquired by Boston Scientific Corporation, Natick, MA, in January 2007) and the FilterWire EX/EZ Emboli Protection System (Boston Scientific Corporation). The investigators concluded that the CABERNET trial demonstrated that carotid stenting (CAS) with NexStent and FilterWire is noninferior to traditional carotid endarterectomy (CEA) at 1 year in high-surgical-risk patients based on historical controls.
As detailed by the investigators, CABERNET enrolled 454 high-surgical-risk patients with carotid stenosis by angiography 50% for symptomatic patients and 60% for asymptomatic patients. The comparator primary endpoint was the 1-year major adverse event ([MAE] defined as any death, stroke, or myocardial infarction) rate. It was compared with a proportionally weighted objective performance criterion (OPC) of 12.1% representative of published CEA results in similar patients plus a prespecified noninferiority margin (delta) of 4%. A second primary endpoint was the composite rate of 30-day MAE plus late (31–365 days) ipsilateral stroke. Symptoms of carotid stenosis were present in 24.2% of patients; 36.6% of patients were considered to be at high surgical risk due to comorbid risk factors and 63.4% due to anatomic risk factors. The rate of 30-day MAE plus late ipsilateral stroke was 4.7% (20/438). The comparator primary endpoint of 1-year MAE was 11.6% (51/438) and was noninferior to the OPC of 12.1% (95% upper confidence interval of 14.5% vs OPC plus delta of 16.1%; P=.005). The late ipsilateral stroke rate was 0.7%, and target vessel revascularization rate at 1 year was 2.4%, the investigators reported.
Cerecyte Microcoil Studied to Treat Cerebral Aneurysms
June 5, 2008—Micrus Endovascular Corporation (San Jose, CA) announced the publication of positive data from two clinical studies evaluating the use of the company's bioactive Cerecyte microcoil in the treatment of cerebral aneurysms. Cerecyte platinum microcoils contain a polyglycolic acid filament that researchers suggest may accelerate the healing process, the company stated.
Erol Veznedaroglu, MD, et al published findings on the impact of the Micrus bioactive Cerecyte detachable coils on reducing recurrence rates in Neurosurgery (2008;62:799-806). In the study, the investigators evaluated 81 patients with 89 aneurysms treated exclusively with Cerecyte bioactive microcoils for safety, durability, and effectiveness on recanalization rates. Of the 89 aneurysms, 65% were ruptured, and the mean aneurysm size was 7 mm. Follow-up angiography at a mean of 11.2 months demonstrated a total recurrence rate of 10.7% and recurrences requiring retreatment of 6.7%.
"The Cerecyte bioactive coil seems safe and effective for use in both ruptured and unruptured aneurysms, and the fact that the bioactive polymer is located within the coil makes for handling characteristics similar to those of bare platinum coils," commented Dr. Veznedaroglu.
On May 16, Serdar Geyik, MD, et al published online ahead of print in Neuroradiology, "Endovascular Treatment of Intracranial Aneurysms With Bioactive Cerecyte Coils: Effects on Treatment Stability." The investigators evaluated midterm angiographic follow-up data to assess Cerecyte bioactive microcoils' durability and efficacy in preventing recanalization. The results were based on 78 patients with 84 intracranial aneurysms treated exclusively with Cerecyte bioactive coils. Of those 78 aneurysms, 48 were ruptured and 36 were incidental; 77 were small (<10 mm), six were large (10–25 mm), and one was giant (>25 mm). Follow-up angiography was obtained in 80 aneurysms over a 6-month to 2-year time period, with an overall recanalization rate of 11.3%. Procedure-related morbidity and mortality rates were 2.6% and 1.3%, respectively.
"Although our results provided an improved initial treatment success with relatively low complication and recurrence rates compared to those reported for bare-platinum coils, the effectiveness of Cerecyte bioactive coils in preventing aneurysm recurrence remains to be proven by the ongoing controlled, multicenter, randomized CERECYTE trial," commented investigator Saruhan Cekirge, MD. The company expects further clinical data to be published from individual clinical series, as well as the results from the company's 500-patient CERECYTE prospective, randomized trial conducted by Andrew J. Molyneux, MD.
Ultrasound-Activated Microspheres Studied
May 1, 2008—In Stroke, Andrei V. Alexandrov, MD, et al have published a pilot randomized clinical safety study of sonothrombolysis augmentation with ultrasound-activated perflutren-lipid microspheres for acute ischemic stroke (2008;39:1464-1469). The investigators found that perflutren microspheres reached and permeated beyond intracranial occlusions with no increase in symptomatic intracranial hemorrhage (ICH) after systemic thrombolysis. This suggests the feasibility of further microsphere dose-escalation studies and development of drug delivery to tissues with compromised perfusion, the investigators concluded
According to the investigators, ultrasound transiently expands perflutren-lipid microspheres, transmitting energy momentum to surrounding fluids. They now report a pilot safety/feasibility study of ultrasound-activated microspheres with systemic tissue plasminogen activator (tPA). In the study, stroke patients treated within 3 hours of onset had abnormal TIBI (thrombolysis in brain ischemia) residual flow grades 0 to 3 before tPA on transcranial Doppler (TCD). Randomization included controls (tPA+TCD) or target (tPA+TCD+2.8 mL microspheres). The primary safety endpoint was symptomatic ICH with worsening by four NIHSS points within 72 hours.
Fifteen subjects were randomized 3:1 to target (n=12) or control (n=3). After treatment, asymptomatic ICH occurred in three target subjects and one control subject, and symptomatic ICH was not seen in any study subject. Microspheres reached middle cerebral artery occlusions in all target subjects at velocities higher than surrounding residual red blood cell flow: 39.8±11.3 versus 28.8±13.8 cm/second (P<.001). In 75% of subjects, microspheres permeated to areas with no pretreatment residual flow, and in 83% residual flow velocity improved at a median of 30 minutes from start of microsphere infusion (range, 30 seconds to 120 minutes) by a median of 17 cm/second (118% above pretreatment values).
To provide perspective, current study recanalization rates were compared with the tPA control arm of the CLOTBUST (Combined Lysis of Thrombus in Brain Ischemia With Transcranial Ultrasound and Systemic TPA) trial: complete recanalization (50% vs 18%), partial (33% vs 33%), and none (17% vs 49%; P=.028). At 2 hours, sustained complete recanalization was 42% versus 13% (P=.003), and NIHSS scores 0 to 3 were reached by 17% versus 8% (P=.456), the investigators reported.
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