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Cardiac Interventions Today News
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| REGULATORY UPDATE |
FDA Approves Abbott Vascular's Xience V and Boston Scientific's Promus Coronary DESs
July 2, 2008—Abbott Vascular (Santa Clara, CA) and Boston Scientific Corporation (Natick, MA) separately announced that the FDA has approved Abbott Vascular's Xience V and Boston Scientific's Promus everolimus-eluting coronary stent systems for the treatment of coronary artery disease. The Xience V stent and the Promus stent are identical products sold by the respective companies under the different brand names. The Promus stent is a private-labeled Xience V stent system manufactured by Abbott Vascular and distributed by Boston Scientific under an agreement executed before the 2006 acquisition of Guidant Corporation by Boston Scientific. Both companies announced that their respective products would be launched immediately in the US.
Abbott Vascular stated that the Xience V will be available on both over-the-wire and rapid-exchange delivery systems. The device was launched in Europe and other international markets in October 2006. In Japan, it is under review for regulatory approval.
Boston Scientific stated that the Promus stent is also commercially available in Europe and certain other international markets. With FDA approval of the Promus, the company noted that it now offers two distinct drug-eluting stent platforms—Promus and the Taxus Express2 paclitaxel-eluting coronary stent system. Taxus Express has been available in the US since 2004, and the Taxus Liberté stent, which has been available in Europe since 2006, is pending FDA approval and is not currently available in the US. Boston Scientific will continue to market its internally developed paclitaxel-eluting Taxus stent systems.
According to Abbott Vascular, the Xience V demonstrated superiority over the Taxus Express paclitaxel-eluting coronary stent system in two randomized head-to-head clinical trials. The clinical program for Xience V includes long-term data from a total of 1,362 patients enrolled in the SPIRIT FIRST, SPIRIT II, and SPIRIT III trials. Also, continued access and postapproval programs will enroll more than 14,000 Xience V patients. Abbott Vascular noted that the FDA approved Xience V based in large part on superior results from the 1,002-patient SPIRIT III US pivotal clinical trial. SPIRIT III trial data were summarized in the News section of the May/June issue of Cardiac Interventions Today.
According to Boston Scientific, the Promus stent is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (up to 28 mm long) with reference vessel diameters of 2.5 to 4 mm. The company stated that the next-generation Promus is a highly deliverable stent made from cobalt chromium, which allows for thinner struts without sacrificing strength or visibility. The Abbott-sponsored SPIRIT clinical trials, which supported FDA approval for both devices, indicate that the combination of the polymer/stent platform and the controlled release of the everolimus drug results in excellent deliverability, a strong safety profile, low levels of late loss, and improved efficacy, Boston Scientific stated.
On July 9, Abbott Vascular announced commencement of the XIENCE V USA postapproval study of the Xience V. Six hospitals have been recruiting and enrolling patients since the device received FDA approval on July 2. The company stated that the XIENCE V USA study will evaluate the safety and effectiveness of the Xience V in a real-world clinical setting out to 5 years. The study is designed to evaluate at least 5,000 coronary artery disease patients treated with the device at approximately 250 centers across the US. The primary endpoint of XIENCE V USA is a measure of stent thrombosis every year out to 5 years, as defined by the Dublin/Academic Research Consortium. The coprimary endpoint of the study is the composite rate of cardiac death and any myocardial infarction (Q-wave or non–Q-wave) in patients at 1 year. Secondary endpoints of the study include patient compliance with prescribed antiplatelet medication, measures of retreatment by stenting or surgery, and device and procedural success. The Abbott-sponsored XIENCE V USA study data will also apply to the Boston Scientific's Promus stent system.
FDA Extends Review Period for Prasugrel and TRILOGY ACS Phase 3 Trial Commences
June 23, 2008—Daiichi Sankyo Company, Ltd. (Tokyo, Japan) and Eli Lilly and Company (Indianapolis, IN) announced that the FDA has extended the review period for the prasugrel new drug application (NDA) based on supplemental information provided during the review period. The NDA was granted priority review by the FDA in February 2008. The 3-month extension allows the FDA time to complete its review. The new FDA action date for prasugrel is September 26, 2008. The proposed indication for prasugrel, an oral antiplatelet agent, is for the treatment of patients with acute coronary syndromes (ACS) being managed with percutaneous coronary intervention.
The companies also confirmed the start of the TRILOGY ACS (Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes) trial, a large phase 3 clinical trial to compare the effects of prasugrel against clopidogrel (Plavix/Iscover, Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership, New York, NY) in medically managed ACS patients. The study will include approximately 10,000 patients at more than 800 hospitals in 35 countries. Daiichi Sankyo and Eli Lilly are conducting the study in conjunction with the Duke Clinical Research Institute. TRILOGY ACS is a multicenter, double-blind, randomized, controlled trial to evaluate the safety and efficacy of prasugrel against clopidogrel in reducing the risk of cardiovascular death, heart attack, or stroke in ACS patients who are to be medically managed without a planned artery-opening procedure.
St. Jude's HydroSteer Wires Receive CE Mark Approval
July 10, 2008—St. Jude Medical, Inc. (St. Paul, MN) today announced CE Mark approval and the European launch of its line of HydroSteer hydrophilic-coated nitinol guidewires. According to the company, the HydroSteer guidewires feature a lubricious hydrophilic coating for easy maneuverability. The design provides excellent control of the guidewire's tip and steerability to navigate challenging vascular structures. The nitinol core resists kinking while providing flexibility. The radiopaque polymer jacket enhances visualization. A torque device enhances steerability by aiding directional control, the company stated.
Cook Medical's GTX BMS Approved in Europe
June 16, 2008—Cook Medical (Bloomington, IN) announced that its cardiology unit, Global Therapeutics, has received CE Mark approval for the GTX new cobalt chromium bare-metal coronary stent and that the company has commenced an immediate market launch of the device in Europe. The company stated that the GTX stent has been engineered to eliminate technical challenges, such as recoil, stent balloon retention, and stent spring-back. Global Therapeutics is also developing a drug-eluting stent technology using the GTX platform and an improved antisense gene therapy application developed by its partner, AVI BioPharma, Inc. (Corvallis, OR) to inhibit the proliferation of a gene known to induce the restenosis process. The clinical trial is expected to begin in the third quarter of 2008 in Europe, the company stated.
FDA Warns CT Scans May Cause Device Malfunctions
July 14, 2008—The FDA Center for Devices and Radiological Health issued a preliminary public health notification alerting healthcare professionals to the possibility that the x-rays used during CT examinations may cause some implanted and external electronic medical devices to malfunction. The notification also provides recommendations to reduce the potential risk. The complete notification is available on the FDA Web site, www.fda.gov/cdrh, including requirements and procedures for reporting adverse events.
Problems with electronic medical devices that might be caused by CT scanner interference include generation of spurious signals, including cardiac defibrillation pulses, misinterpretation of signals produced by the x-rays as actual biological signals, missed detection of actual biological signals, and resetting or reprogramming of device settings. The type of effect, if any, is likely to depend on the device type, the manufacturer, and the model.
According to the FDA, most patients with electronic medical devices undergo CT scans without any adverse consequences; however, the agency has received a small number of reports of adverse events in which CT scans may have interfered with electronic medical devices, including pacemakers, defibrillators, neurostimulators, and implanted or externally worn drug-infusion pumps. There have been similar reports in the literature. To date, no patient deaths have been reported from CT scanning of implanted or externally worn electronic medical devices.
In the reports received by the FDA, the following adverse events were likely to have been caused by x-rays from CT scans: unintended "shocks" (ie, stimuli) from neurostimulators, malfunctions of insulin infusion pumps, and transient changes in pacemaker output pulse rate. The agency noted that malfunctions of this kind, which can result from direct exposure of the medical device to the high x-ray dose rates generated by some CT equipment, are different from those related to MRI scanning, which are caused by strong electric and magnetic fields.
The FDA recommended that before beginning a CT scan, operators should use CT scout views to determine if implanted or externally worn electronic medical devices are present and if so, their location relative to the programmed scan range. For CT procedures in which the medical device is in or immediately adjacent to the programmed scan range, the operator should (1) determine the device type, (2) if practical, try to move external devices out of the scan range, (3) ask patients with neurostimulators to shut off the device temporarily while the scan is performed, and (4) minimize x-ray exposure to the implanted or externally worn electronic medical device by using the lowest possible x-ray tube current consistent with obtaining the required image quality and making sure that the x-ray beam does not dwell over the device for more than a few seconds.
The FDA stressed that, for CT procedures that require scanning over the medical device continuously for more than a few seconds, as with CT perfusion or interventional exams, attending staff should be ready to take emergency measures to treat adverse reactions if they occur.
After CT scanning directly over the implanted or externally worn electronic medical device: (1) have the patient turn the device back on if it had been turned off before scanning; (2) have the patient check the device for proper functioning, even if the device was turned off; and (3) advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan.
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| LITERATURE HIGHLIGHTS |
AHA Scientific Statement Addresses Coronary Imaging
June 27, 2008—David Bluemke, MD, et al have published online ahead of print in Circulation an American Heart Association (AHA) scientific statement on noninvasive coronary artery imaging, magnetic resonance angiography (MRA) and multidetector computed tomography angiography (CTA). The scientific statement is from the AHA Committee on Cardiovascular Imaging and Intervention of the Council on Cardiovascular Radiology and Intervention, and the Councils on Clinical Cardiology and Cardiovascular Disease in the Young.
The statement discusses and summarizes MRA and CTA, imaging modalities that may be used for coronary artery evaluation. Because the advantages and limitations of CT to assess the presence and extent of coronary arterial calcification are discussed in a separate document sponsored by the AHA, the assessment of coronary arterial calcification is not presented in this statement. The statement discusses technical issues, applications, advantages, and limitations for both MRA and CTA. The investigators then provide recommendations for current and future uses. To accomplish this, the Writing Committee conducted a comprehensive review of the literature published between 1990 and 2006. Literature searches of the PubMed/MEDLINE databases were undertaken to identify pertinent English-language articles. The major search terms included coronary angiography, coronary disease, coronary vessels, humans, magnetic resonance angiography, tomography, and x-ray computed.
According to the investigators, noninvasive coronary CTA and MRA represent substantial advances that may ultimately be valuable for diagnosis of significant coronary artery disease. The chief advantages of coronary CTA compared with MRA are wider availability, higher spatial resolution, and more consistent, shorter examinations with better patient adherence. Advantages associated with coronary MRA are a lack of ionizing radiation and a lack of administration of iodinated contrast material. Both tests are presently suboptimal for patients with atrial fibrillation and other arrhythmias, and image quality may be further reduced by high body mass. Specific recommendations for use of these technologies are expected to change along with advances in scanner hardware and software, the investigators noted.
The investigators presented the following general statements that represent the consensus opinions of the writing group. (The classification of recommendations and levels of evidence for each recommendation are expressed in the American College of Cardiology/AHA format. They are outlined in the statement.)
Neither coronary CTA nor MRA should be used to screen for coronary artery disease in patients who have no signs or symptoms suggestive of coronary artery disease.
No multivendor trial data are available for coronary multidetector CTA or for present whole-heart coronary MRA. Thus, the applicability of these methods beyond the reporting research centers is unknown. Ideally, both multivendor and additional multicenter validation of these methods should be performed.
(1) The potential benefit of noninvasive coronary angiography is likely to be greatest and is reasonable for symptomatic patients who are at intermediate risk for coronary artery disease after initial risk stratification, including patients with equivocal stress test results. (2) Diagnostic accuracy favors coronary CTA over MRA for these patients. (3) Concerns regarding radiation dose limit the use of coronary CTA in high-risk patients who have a very low pretest likelihood of coronary stenoses; patients with a high pretest likelihood of coronary stenoses are likely to require intervention and invasive catheter angiography for definitive evaluation; thus, CTA is not recommended for those individuals. (4) Pronounced coronary calcification may negatively impact interpretability and accuracy of coronary CTA and thus, the usefulness of CTA is uncertain in these individuals.
Anomalous coronary artery evaluation can be performed by either CTA or MRA; radiation-protection concerns indicate that MRA is preferred when it is available.
Reporting of coronary CTA and MRA results should describe any limitations to the technical quality of the examination and the size of the vessels, descriptions of coronary anomalies, coronary stenosis, and significant noncardiac findings within the field of view.
Continued research in cardiac CT and MR imaging is encouraged to determine the potential of these noncatheter-based modalities to detect, characterize, and measure atherosclerotic plaque burden, as well as its change over time or as the result of therapy.
Study Measures Impact of Prevention on CVD Rates
July 7, 2008—A study published online ahead of print in Circulation by Richard Kahn, PhD, et al concluded that aggressive application of nationally recommended prevention activities could prevent a high proportion of the coronary artery disease events and strokes that are otherwise expected to occur in adults in the US. However, the investigators found that most of the prevention activities will substantially increase costs as they are currently delivered. If preventive strategies are to achieve their full potential, ways must be found to reduce the costs and deliver prevention activities more efficiently, the investigators asserted.
The investigators noted that cardiovascular disease (CVD) is prevalent and expensive, and although many interventions are recommended to prevent CVD, the potential effects of a comprehensive set of prevention activities on CVD morbidity, mortality, and costs have never been evaluated. Therefore, the study was conducted to determine the effects of 11 nationally recommended prevention activities on CVD-related morbidity, mortality, and costs in the US.
As detailed in Circulation, the study used person-specific data from a representative sample of the US population (National Health and Nutrition Education Survey IV) to determine the number and characteristics of adults aged 20 to 80 years in the US who are candidates for different prevention activities related to CVD. The Archimedes model was used to create a simulated population that matched the real US population, person by person. The investigators then used the model to simulate a series of clinical trials that examined the effects over the next 30 years of applying each prevention activity one by one, or all together, to those who are candidates for the various activities and compared the health outcomes, quality of life, and direct medical costs to current levels of prevention and care. This study was conducted under two sets of assumptions about performance and compliance: 100% success for each activity and lower levels of success considered aggressive but still feasible. The investigators determined that approximately 78% of US adults aged 20 to 80 years are candidates for at least one prevention activity.
On July 14, Circulation published online ahead of print an article, "Translating Research Into Practice for Healthcare Providers," by Daniel W. Jones, MD, et al regarding the American Heart Association's strategy for building healthier lives, free of cardiovascular diseases and stroke. The article is the first in a two-part series that will present an overview of the work the AHA has undertaken to translate evidence into practice for healthcare professionals. The authors describe the extensive work of the AHA to support and advance the delivery of evidence-based medicine, which includes the following: (1) supporting scientific discovery and the next generation of healthcare professionals and researchers; (2) disseminating scientific information; (3) developing evidence-based guidelines and statements; (4) creating and advocating for the implementation of performance indicators/measures; (5) developing clinical decision support and quality improvement tools; and (6) developing directed-cause campaigns. All of these functions can lead to improved patient care, the authors state. The article also discusses the need for novel approaches and some of the AHA's evolving strategies to help address gaps in care. The second article will examine the AHA's efforts to engage and empower healthcare consumers to become more involved with their own health and health care.
Study Evaluates Amplatzer PFO Closure Complications
July 1, 2008—In Catheterization & Cardiovascular Interventions, Zahid Amin, MD, et al published findings from an evaluation of all complications that occurred during or after cardiac catheterizations for closure of patent foramen ovale (PFO) with the Amplatzer PFO closure device (AGA Medical Corporation, Plymouth, MN) to determine the cause of the complications and recommend techniques to minimize complications in the future (2008;72:74-79). Rare complications were reported to the manufacturer of the Amplatzer PFO occluder since the introduction of the device, the investigators noted.
In the study, a panel of independent physicians reviewed all complications reported to the manufacturer to determine whether a complication was related to the device or related to the cardiac catheterization procedure. Demographic data, echocardiograms, operative reports, and time to occurrence of complications were reviewed. A total of 11 events were reported. Only two patients had device-related complications (erosion), an incidence of .018%. Two patients were found to have an additional atrial septal defect after PFO closure. Two patients were thought to have an inflammatory reaction without any serious sequelae. Five complications were related to the cardiac catheterization procedure (atrial appendage perforation). The investigators found that device-related complications after Amplatzer PFO occluder placement are extremely rare and that cardiac catheterization-related complications appear to be the most common cause of the hemodynamic compromise. Careful manipulation of catheters and wires and recognition of the location of the catheter by fluoroscopy and echocardiography will decrease the risk of such complications, the investigators concluded.
Medtronic's Interceptor Plus AMETHYST Data Published
June 1, 2008—The results of the AMETHYST (Assessment of the Medtronic AVE Interceptor Saphenous Vein Graft Filter System) randomized controlled trial were published by Dean J. Kereiakes, MD, et al in the Journal of the American College of Cardiology: Cardiovascular Interventions (2008;1:248-257). In AMETHYST, the investigators evaluated the relative safety and efficacy of the novel Interceptor Plus coronary filter system (Medtronic Vascular, Santa Rosa, CA) compared with approved embolic protection devices (eg, GuardWire, Medtronic Vascular and FilterWire EZ, Boston Scientific Corporation, Natick, MA) during percutaneous coronary intervention (PCI) of degenerative saphenous vein grafts (SVG). The investigators concluded that the Interceptor Plus coronary filter system is noninferior in safety and efficacy to 30 days when compared with the GuardWire and FilterWire EZ distal embolic protection devices.
As the investigators noted, the background of the study was that PCI of degenerative SVG is associated with embolization of atherothrombotic debris and subsequent myocardial infarction in a significant portion of patients. The use of distal embolic protection devices has previously been demonstrated to reduce major adverse cardiovascular events associated with PCI in these patients.
In this multicenter, randomized noninferiority trial, 797 patients undergoing PCI with stenting of SVG stenoses (de novo or restenotic) with reference vessel diameter 2.5 to 5.25 mm were randomly assigned 2:1 to either the Interceptor Plus (n=533) or control distal protection devices (GuardWire [n=191], FilterWire EZ [n=73]) at the physician's discretion. The trial's primary clinical endpoint (composite occurrence of death, myocardial infarction, or urgent repeat revascularization through 30 days) was observed in 8% of Interceptor patients and 7.3% of control-treated patients (P=.025 for noninferiority; P=.77 for difference). Key secondary endpoints for device and procedural success were similar between randomly assigned treatment strategies.
Studies Published of Abciximab Bolus in PCI
July 1, 2008—Two studies of abciximab bolus administration with percutaneous coronary interventions have been published in the American Heart Journal and in Circulation.
In the American Heart Journal, Olivier F. Bertrand, MD, PhD, et al published the 1-year clinical outcome data in patients after abciximab bolus-only compared to patients with abciximab bolus and 12-hour infusion in the randomized Early Discharge after Transradial Stenting of Coronary Arteries (EASY) study (2008;156:135-140). The investigators concluded that in patients pretreated with clopidogrel and undergoing uncomplicated coronary artery stenting, there is no difference in the 6- and 12-month outcomes between patients treated with abciximab bolus only versus those treated with bolus + infusion, a finding consistent with the initial 30-day outcomes.
According to Dr. Bertrand and colleagues in the EASY study, long-term clinical follow-up has shown a significant benefit after percutaneous coronary intervention (PCI) for abciximab bolus followed by 12-hour infusion over placebo or bolus only. With contemporary techniques and clopidogrel pretreatment, it is unknown whether the 12-hour infusion is still associated with a clinical benefit. The purpose of the EASY study is to compare 6- and 12-month clinical outcomes in patients treated after PCI with abciximab bolus only and abciximab bolus followed by 12-hour infusion.
In the study, after a bolus of abciximab (0.25 mg/kg) and uncomplicated transradial coronary stenting, 1,005 patients were randomized either to same-day discharge and no infusion of abciximab (bolus-only group, n=504) or to overnight hospitalization and 12 hours (0.125 µg/[kg/min]) of abciximab infusion (bolus + infusion group, n=501). The rate of major adverse cardiovascular events (MACE) was evaluated at 30 days, 6 months, and 12 months.
As detailed in the American Heart Journal, at 30 days, the rate of MACE, including death, myocardial infarction, and target vessel revascularization, was similar in the two groups: 1.4% in the bolus-only group versus 1.8% in the bolus + infusion group (P=.63). At 6 months, the MACE rate was 5.6% in the two randomized groups. At 12 months, the MACE rate was also similar in both groups: 8.7% in the bolus-only group and 9.2% in the bolus + infusion group (hazard ratio .97; 95% CI, .79–1.20, P=.8). Similar efficacy was also observed in several subgroups including higher-risk patients such as those with elevated troponin T before PCI.
In Circulation, Holger Thiele, MD, et al have published a study in which they conclude that intracoronary bolus administration of abciximab in primary percutaneous coronary intervention (PCI) is superior to standard intravenous treatment with respect to infarct size, extent of microvascular obstruction, and perfusion (2008;118:49-57).
According to the the investigators, the background of their study is that it is known that abciximab reduces major adverse cardiac events in patients with ST-elevation myocardial infarction undergoing primary PCI. Intracoronary abciximab bolus application results in high local drug concentrations and may be more effective than a standard intravenous bolus.
As detailed in Circulation, patients undergoing primary PCI were randomized to either intracoronary (n=77) or intravenous (n=77) bolus abciximab administration with subsequent 12-hour intravenous infusion. The study's primary endpoint was infarct size and extent of microvascular obstruction as assessed by delayed enhancement magnetic resonance. Secondary endpoints were ST-segment resolution at 90 minutes, thrombolysis in myocardial infarction (TIMI) flow and perfusion grades after PCI, and the occurrence of major adverse cardiac events within 30 days. The median infarct size was 15.1% (interquartile range, 6.1% to 25.2%) in the intracoronary versus 23.4% (interquartile range, 13.6% to 33.2%) in the intravenous group (P=.01). Similarly, the extent of microvascular obstruction was significantly smaller in intracoronary patients compared with intravenous abciximab patients (P=.01). Myocardial perfusion measured as early ST-segment resolution was significantly improved in intracoronary patients with an absolute ST-segment resolution of 77.8% (interquartile range, 66.7% to 100%) versus 70% (interquartile range, 45.2% to 83.5%; P=.006). TIMI flow after PCI was not different between treatment groups (P=0.51), but there was a trend toward an improved perfusion grade (P=.09). There was also a trend toward a lower major adverse cardiac event rate after intracoronary versus intravenous abciximab application (5.2% vs 15.6%; P=.06; relative risk, .33; 95% CI, .09–1.05), the investigators reported in Circulation.
Stenting Results Compared in BMS Era and DES Era
June 25, 2008—Findings from a study that compared outcomes of Medicare beneficiaries who underwent nonemergent coronary stenting before and after the availability of drug-eluting stents (DESs) were published by David J. Malenka, MD, et al in the Journal of the American Medical Association (2008;299:2868-2876). The investigators noted that although DESs reduce restenosis rates relative to bare-metal stents (BMSs), concerns have been raised that DESs may also be associated with an increased risk of stent thrombosis. This study focused on the effect of stent type on population-based interventional outcomes. The investigators concluded that the widespread adoption of DESs into routine practice was associated with a decline in the need for repeat revascularization procedures and had similar 2-year risks for death or ST-elevation myocardial infarction (STEMI) compared to BMSs.
According to the investigators, this is an observational study of 38,917 Medicare patients who underwent nonemergent coronary stenting from October 2002 through March 2003, when only BMSs were available (BMS-era cohort) and 28,086 similar patients who underwent coronary stenting from September through December 2003, when 61.5% of patients received a DES and 38.5% received a BMS (DES-era cohort). Follow-up data were available through December 31, 2005. The main outcome measures were coronary revascularization (percutaneous coronary intervention, coronary artery bypass surgery), STEMI, and survival through 2 years of follow-up.
The investigators reported that relative to the BMS era, patients treated in the DES era had lower 2-year risks for repeat percutaneous coronary interventions (17.1% vs 20%; P<.001) and coronary artery bypass surgery (2.7% vs 4.2%; P<.01). The difference in need for repeat revascularization procedures between these two eras remained significant after risk adjustment (hazard ratio, .82; 95% confidence interval, .79–.85). There was no difference in unadjusted mortality risks at 2 years (8.4% vs 8.4%; P=.98), but a small decrease in STEMI existed (2.4% vs 2%; P<.001). The adjusted hazard ratio of death or STEMI at 2 years was similar (hazard ratio, 0.96; 95% confidence interval, .92–1.01), the investigators found.
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| INDUSTRY NEWS |
Inoperable Atresia Treated With Stereotaxis's Niobe
July 16, 2008—Stereotaxis, Inc. (St. Louis, MO) announced that the pediatric cardiology team at the Heart and Diabetes Center of North Reinland-Westphalia in Bad Oeynhausen, Germany, successfully performed a first-of-its-kind procedure to treat pulmonary atresia in a 10-year-old boy. The team performed the procedure with the Stereotaxis Niobe magnetic navigation system. The team was lead by Nikolaus Haas, MD, Director of the Catheterization Laboratory in the Department of Congenital Heart Defects at the Heart and Diabetes Center. The case underscores the value of the Niobe navigation system as a platform for a broad range of interventional procedures beyond its core electrophysiology applications, the company stated.
According to the company, the patient had failed a previous surgical attempt to correct the atresia because there were no vessels of adequate size or quality to utilize. After two conventional catheterization attempts, Dr. Haas's team used Stereotaxis's software to create a 3D model of the tortuous vessels that had replaced this patient's absent pulmonary artery. Using the Niobe magnetic navigation system, the team then navigated a magnetic guidewire through the entire length of the difficult vessel and placed a specialized stent to permit increased blood flow from the aorta to the left lung, increasing the amount of oxygen that can be pumped throughout the body. The patient was discharged from the hospital within 2 days after the procedure.
Before the procedure, the patient was cyanotic and could not walk 100 meters without running out of breath. After the procedure, the patient's color is good, and he is able to walk more than 1,000 meters before needing to rest. Dr. Haas believes that the patient will experience still greater improvement after a second, planned procedure to improve blood flow to his right lung and that the patient is well on the road to being able to participate in day-to-day activities, such as walking to school and playing with friends.
Dr. Haas stated that, based on this initial experience with the Stereotaxis Niobe system, his team has already scheduled another patient with pulmonary atresia for the procedure. He added that in their current patient population alone, there are at least 20 additional children with this disease who can benefit from the unique capabilities of the Stereotaxis technology.
Prescient's vProtect Studied to Treat Vulnerable Plaque
June 30, 2008—Prescient Medical, Inc. (Doylestown, PA) announced commencement of the SECRITT I (Study to Evaluate Preventive Treatment of Potentially Life-Threatening Vulnerable Plaque) pilot study designed to evaluate the company's vProtect luminal shield as a treatment for vulnerable plaques in the coronary arteries. The shield was designed for use in soft lesions with features including easy, self-expanding deployment and ultra-thin struts that, the company says, make it well suited for use in vulnerable plaque and useful in other lesions in which balloon-expanding stents are currently used. The vProtect luminal shield's design matches the mechanical properties of the coronary artery and may reduce some of the adverse effects associated with traditional stents, the company stated.
Professor Patrick W. Serruys, MD, led an interventional cardiology team in the initial case in which a vProtect luminal shield was placed in the left anterior descending coronary artery of a 64-year-old man at Erasmus Medical Center in Rotterdam, The Netherlands.
According to the company, the SECRITT investigators plan to place the self-expanding vProtect device in 15 patients with plaques identified as vulnerable by a combination of ultrasound and optical imaging techniques. These patients will be matched with 15 control patients who will not receive the shield. All patients are elective patients that have been referred to the catheterization lab for the treatment of a major lesion impairing normal cardiac function. All 30 patients will undergo follow-up diagnostic catheterizations 6 months after the initial treatment visit, at which time their lesions will be re-evaluated. This information will enable the investigators to observe whether the shield has stabilized the target lesions, the company stated.
The company noted that recent studies have shown that most culprit lesions in myocardial infarctions (MIs) narrow the vessel lumen by <50% before the infarct, and only 15% of acute MIs arise from lesions that are >60% narrowed on a previous angiogram. Most of these vulnerable plaques would not be eligible for treatment with angioplasty and stenting. The vProtect luminal shield is also undergoing clinical testing for indications in which traditional stents are used—in relatively stable, flow-limiting coronary lesions, the company stated.
"We are very good at opening arteries that are blocked, but we have not succeeded in preventing MIs related to plaque rupture," commented Dr. Serruys. "Now is the time to take a new approach, to try to prevent the plaque rupture and prevent the acute event, rather than try to repair the damage after the fact. The kind of plaques we are treating in SECRITT do not cause symptoms or seriously affect blood flow, but they are prone to rupture, which can cause thrombus. The vProtect luminal shield is designed to prevent that rupture, thereby preventing the thrombus, and the resulting MIs."
SCAI Creates Structural Heart Disease Council
June 18, 2008—The Society for Cardiovascular Angiography and Interventions (SCAI) announced the creation of the Structural Heart Disease Council to develop guidelines and training standards for the emerging interventional cardiology subspecialty field of structural heart disease. The council's mission includes encouraging research, delivering professional education, facilitating development of guidelines, fostering advocacy, and promoting public education and communication about the potential of interventional therapies for congenital and acquired structural heart conditions. SCAI stated that the Structural Heart Disease Council will create a forum for worldwide collaboration on issues facing cardiovascular specialists who treat structural heart disease, so that they have guidelines, tools, and resources that will help them to provide optimal patient care. SCAI envisions a multispecialty effort to promote communication and cooperation among organizations and cardiovascular societies in the field.
Ziyad M. Hijazi, MD, president of SCAI, and Ted Feldman, MD, past president of SCAI, will co-chair the SCAI Structural Heart Disease Council.
Among the goals for the SCAI Council is to facilitate the development of guidelines for training of physicians in structural heart disease intervention in collaboration with both the American Board of Internal Medicine and the American Board of Pediatrics. The Council will also facilitate in establishing objective performance criteria for interventional therapies in structural heart conditions, including aortic valve replacement, mitral valve repair/replacement techniques, pulmonary valve replacement, left atrial appendage closure, and mitral and aortic paravalvar leaks. The SCAI Structural Heart Disease Council will include SCAI Fellow members, as well as representatives from a diverse range of professional medical societies committed to working together to advance the field and achieve the highest-quality care for patients.
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