Endovascular Repair of Mitral Valve Alternative to Surgery In EVEREST II, the MitraClip Shows Superior Safety, Similar EffectivenessA catheter-mounted device that acts like a clothespin to clip together the flaps of a leaky heart valve is a safe and effective alternative to open-chest surgery in selected patients with mitral regurgitation, according to research presented at the American College of Cardiology’s 59th annual scientific session. The Endovascular Valve Edge-to-Edge Repair Study (EVEREST II) involved patients with significant regurgitation through the mitral valve. The study showed that patients treated with the MitraClip valve repair system were one-sixth as likely as surgical patients to experience a serious complication within 30 days of the procedure. After one year, the clinical effectiveness of the two treatment strategies appeared similar. “As clinicians, we have seen our patients transformed from highly symptomatic to highly functional with a catheter procedure – and without a long hospital stay or a long recovery period,” said Ted Feldman, MD, director of the cardiac catheterization laboratory for NorthShore University Health System, Evanston, IL. “The real excitement is seeing our experience with individual patients reflected in trial results in a clear way.” More than 250,000 people in the United States are diagnosed with mitral regurgitation each year. The MitraClip procedure typically allows patients to engage in normal daily activities within a week, versus 6 weeks with surgery. A needle puncture in the wall separating the upper chambers of the heart enables the catheter to pass into the left atrium, where the clip is opened up like a clothespin. It is then passed through the mitral valve into the left ventricle. When the heart contracts, the leaflets of the mitral valve fall into the clip, which is then closed, pinning the edges of the leaflets together at their centers. The result is a bow-tie-shaped opening that permits blood flow from the left atrium to the left ventricle during relaxation of the heart, and enables the valve to close more effectively during contraction, rather than allowing leakage of blood backward into the left atrium. The EVEREST II study was designed to evaluate the safety and effectiveness of the MitraClip procedure in comparison with open-chest mitral valve surgery. For the study, researchers from 37 North American medical centers recruited 279 patients who fit the American College Cardiology/American Heart Association guidelines for mitral valve surgery (moderate-to-severe [Grade 3+] or severe [Grade 4+] mitral regurgitation). Patients were randomly assigned in a 2-to-1 ratio to treatment with the MitraClip device (184 patients) or mitral valve repair or replacement surgery (95 patients). The MitraClip procedure was successful in 137 patients, and of these, 136 were available for inclusion in the data analysis at 30 days; 79 surgical patients were available for 30-day follow-up. The comparative safety of the two procedures was gauged by major adverse clinical events (MACE) at 30 days. The 30-day MACE rate in the MitraClip group was 9.6% (representing transfusions in 8.8% and gastrointestinal complications in 0.7%), as compared with 57% in the surgery group (transfusions, 53.2%; need for a ventilator for more than 48 hours, 5.1%; urgent/emergency surgery, 5.1%; death, 2.5%; and stroke, 2.5%). The difference between the two groups represented a highly significant finding of superior safety with the MitraClip, according to the researchers. The comparative effectiveness of the two procedures was gauged at 12 months by freedom from a combination of death, new surgery for mitral valve dysfunction, or more than mild mitral regurgitation. Clinical success was achieved at 12 months by 72.4% of patients treated with the MitraClip and 87.8% of those treated with surgery, a highly significant finding of the “noninferiority” of the MitraClip. At 30 days, quality of life was significantly improved in the MitraClip group, but was worse in the surgery group. By 12 months, both groups reported significant improvement in quality of life. The EVEREST II study was funded by Evalve, which also provides research funding to NorthShore University Health System. Dr. Feldman is a consultant to Abbott, which recently acquired Evalve.
More Research Needed to Determine Best Treatment of Multi-Vessel CAD During Primary PCI for STEMI Multi-vessel Primary PCI is Performed Frequently Despite Current Recommendations to the ContraryNearly 14% of Medicare beneficiaries admitted with a primary diagnosis of ST-segment elevation myocardial infarction (STEMI) undergo multi-vessel primary percutaneous coronary intervention (PCI), despite recommendations from the American College of Cardiology and the American Heart Association to intervene on only the culprit vessel. Those patients undergoing multi-vessel intervention experience higher unadjusted morbidity/mortality than those patients undergoing single-vessel PCI. However, multi-vessel PCI was not a significant predictor of mortality once co-morbid conditions were controlled in the regression model. These are among the findings of new research presented this week by Dr. Aaron D. Kugelmass of Baystate Medical Center at the American College of Cardiology’s Scientific Sessions 2010 in Atlanta. Read the research at: http://tinyurl.com/ycue7xb. According to the study, STEMI patients undergoing multi-vessel PCI were more likely to be male, experience cardiogenic shock and have a drug-eluting stent. They also experience increased unadjusted in-hospital mortality, are more likely to experience acute renal failure, and have a lower incidence of CABG than those undergoing single-vessel PCI. The research, funded and conducted by Cardiac Data Solutions, studied data on Medicare beneficiaries (MB) with a primary diagnosis of STEMI (first diagnosis code) that underwent a PCI during hospitalization between October 1, 2006 and September 30, 2007 and included 24,189 MB. The study compared the following clinical outcomes between the MB undergoing single-vessel versus multi-vessel PCI: acute renal failure, new-onset hemodialysis, any vascular complication, observed mortality, expected mortality, and stent type and usage. “The study supports the current recommendations that STEMI patients undergo culprit vessel PCI only; however, prospective assessment of this question is needed to identify the best treatment strategy for patients with STEMI and multi-vessel CAD,” said April Simon, RN, MSN, president of Cardiac Data Solutions and one of the researchers. For more information, visit http://www.cardiacdatasolutions.com.
GE’s Virtual Sleep Lab Enables Sleep Apnea Testing in Hospitalized Cardiac Patients Half of Heart Disease Patients Have Sleep Apnea, 80% of Sleep Apnea Patients Remain UndiagnosedGE Healthcare introduced Mars® Virtual Sleep Lab (VSL), the first device to provide a streamlined view of quantitative cardiac and sleep apnea analysis from any GE-monitored inpatient bed, helping enhance speed of diagnosis. Mars VSL was featured at the American College of Cardiology (ACC) 59th Annual Scientific Session. Integrating a sleep disorder diagnostic tool into hospital cardiac care represents an important advance, as obstructive sleep apnea (OSA) impacts up to 50% of all heart disease patients.1 When sleep disorders are diagnosed and treated early, it has been shown to improve cardiac conditions. Left undiagnosed, sleep apnea can increase heart disease risks. More than 80% of individuals with moderate-to-severe OSA have not been clinically diagnosed.2 Powered by the WideMed Ltd. Morpheus® Hx sleep apnea diagnosis program, Mars VSL enables OSA diagnosis right from the hospital bed. This transforms inpatient rooms into virtual sleep labs, and enables a bedside diagnosis by improving utilization of monitored data to provide diagnostic information. According to a recent Journal of Clinical Sleep Medicine study, connecting the WideMed automated sleep analysis system to hospital monitors achieves results highly correlated with the standard test conducted in sleep labs, called polysomnography.3 Mars VSL automatically reports on clinical data that is critical for making a sleep apnea diagnosis, such as apnea hypopnea index, sleep staging and respiratory events. Following a sleep apnea diagnosis, an AutoPAP device can be immediately prescribed while the patient is still in the hospital. This increases the chance that OSA patients can begin treatment before other complications develop. Mars VSL enables not only sleep apnea diagnostic testing, but also quantitative Holter analysis for in-hospital cardiac patients. Hospitals can use Mars VSL with existing cardiac technologies.
1. Milleran O, et al. Eur Heart J 2004 May; 25:728-734. 2. The Medical Cost of Undiagnosed Sleep Apnea. V. Kapur, et al. SLEEP, Vol. 22, No. 66, 1999. 3. An Automated Sleep-Analysis System Operated through a Standard Hospital Monitor. O. Amir, et al. Journal of Clinical Sleep Medicine, Vol. 6, No. 1, 2010.
Extended Use of Dual Antiplatelet Therapy Not Effective Dual antiplatelet therapy no more effective than aspirin-only therapy for long-term treatmentCoronary patients should not continue dual antiplatelet therapy one year after receiving a drug-eluting stent, according to research presented at the American College of Cardiology’s 59th annual scientific session. The optimal duration of dual antiplatelet therapy administration following drug-eluting stent implantation had not previously been determined. For this study, patients either continued to receive clopidogrel 12 months after drug-eluting stent implantation or discontinued the medication. A total of 2,701 patients, who had had no major complications in the year since receiving drug-eluting stents, were randomized to the clopidogrel discontinuation group (1,344 patients) or the clopidogrel continuation group (1,357 patients). During a follow-up period which had a median of 19.2 months, the cumulative risk of the primary outcome (a composite measure of cardiac death and heart attack) at two years was 1.8% with dual antiplatelet therapy versus 1.2% with aspirin-only therapy. The individual risks of death, myocardial infarction, stroke, stent thrombosis, repeat revascularization or major bleeding were not different between the two groups. However, in the group that received dual antiplatelet therapy, there was a nonsignificant increase in the composite risk of death, heart attack or stroke and in the composite risk of cardiac death, heart attack or stroke. “Extended use of dual antiplatelet therapy beyond 12 months among patients who received drug-eluting stents was not significantly more effective than aspirin-only therapy in reducing the rate of cardiac death or heart attack,” said Dr. Seung-Jung Park, of the Asan Medical Center, Seoul, South Korea and the study’s lead researcher. “These findings provide a key direction for the future of post-drug-eluting stent treatment.” Despite the findings, Dr. Park did caution that these findings should be confirmed or refuted through larger, randomized clinical trials with longer-term follow up. Dr. Park reports no disclosures.
Toshiba Introduces New X-Ray System with 12”x12” Flat Panels and Hybrid Catheterization Table at ACC 2010When working on patients in a hybrid setting, it is critical the imaging system provides outstanding image quality, as well as the flexibility to reach ancillary equipment and the patient quickly and easily. Toshiba America Medical Systems, Inc. showcased its Infinix™ VF-i biplane system with two identical 12’’ x 12’’ flat panel detectors and the CAT 880B hybrid catheterization table at this year’s American College of Cardiology (ACC) annual meeting. The new mid-sized 12’’ x 12” flat panel detector expands the versatility of the Infinix-i line, which features a five-axis C-arm positioner and enables unprecedented patient access and coverage. The new mid-sized flat panel detector covers more anatomical area in one view. The ability to see more anatomy in one view reduces C-arm movement or table panning and decreases overall procedure time. The flexible system accommodates acquiring all standard views of the heart and is also beneficial when imaging anatomy outside the heart. Along with the new mid-sized detector, the Infinix-i five-axis systems are now available with the new CAT 880B tilt/cradle hybrid catheterization table. This table is designed to allow greater positioning flexibility and patient access during imaging and surgery. The table functionality with side-to-side cradle and head-to-toe tilt permits clinicians to angle the table in the optimal position to complete procedures. The flexibility and ergonomic design enhance the clinicians’ ability to work around the patient and accommodate views that conventional angiographic tables cannot achieve. The new hybrid catheterization table features a 550-pound table weight limit, making this table ideal for a range of patients, from pediatric to bariatric. It also allows for angulations of up to 16 degrees in all four directions and offers the lowest tabletop height available. The 75-cm table height is particularly important for open surgical procedures, as it provides ultimate patient access and physician comfort, regardless of the procedure being performed. With the new table, Toshiba’s Infinix-i five-axis x-ray systems are designed to accommodate endovascular catheter-based techniques, open surgical settings or a combined hybrid approach.
Study Shows Superior Efficacy for Taxus® Express® Stents at One Year Compared to Bare-Metal Stents in Diabetic Patients Experiencing Heart AttackBoston Scientific applies to FDA for expanded indications for Taxus Express and Taxus® Liberte® Stents in AMI patients Boston Scientific Corporation announced results from an analysis of one-year subset data from the HORIZONS AMI trial assessing the impact of diabetes on clinical and angiographic outcomes in heart attack patients treated with the Taxus® Express2™ paclitaxel-eluting stent system or the Express® bare-metal stent. The results demonstrated that the Taxus Express stent significantly reduced ischemia-driven target lesion revascularization (TLR) at one year and binary in-stent restenosis at 13 months in diabetic patients experiencing an acute myocardial infarction (AMI) compared to an otherwise identical bare-metal control stent. Analysis of the data was presented at the American College of Cardiology Annual Scientific Sessions by Bernhard Witzenbichler, MD, Department of Cardiology and Pneumology, Universitatsmedizin Berlin. The Company also announced it has submitted an application to the U.S. Food and Drug Administration (FDA) requesting expansion of the indications for use of the Taxus Express and Taxus Liberte® stents to include patients experiencing AMI. “Results from the HORIZONS AMI trial showed impressive efficacy benefits at one year for diabetic AMI patients treated with the Taxus Express Stent when compared to bare-metal stents,” said Keith Dawkins, MD, Senior Vice President and Chief Medical Officer for Boston Scientific. “The data also showed comparable safety outcomes for Taxus Express and bare-metal stents in diabetic patients. This study provides important data to physicians regarding the use of drug-eluting stents in high-risk AMI patients, especially those with diabetes, during the early hours of a heart attack.” HORIZONS AMI results demonstrated that the Taxus Express stent significantly reduced ischemia-driven TLR compared to the bare-metal control stent (BMS) in both diabetic patients (5.2% vs. 11.2%, p=0.03, a 54% reduction), and non-diabetic patients (4.3% vs. 6.8%, p=0.02, a 37% reduction). Binary in-stent restenosis at 13 months was also significantly reduced for diabetic patients treated with the Taxus Express stent compared to BMS (8.2% vs. 43.9%, pPERSEUS Trial Results Demonstrate Positive Safety and Efficacy Outcomes for Boston Scientific’s Novel Platinum Chromium Taxus® Element™ Stent System Boston Scientific Corporation announced 12-month results from its PERSEUS clinical program that demonstrated positive safety and efficacy outcomes in workhorse lesions for the platinum chromium Taxus® Element™ paclitaxel-eluting stent system compared to the Taxus Express2™ paclitaxel-eluting stent system. Researchers also reported a similar safety profile and statistically superior efficacy outcomes in small vessels for the Taxus Element stent compared to a historical control group of patients receiving the Express bare-metal stent. Analysis of the data was presented at the American College of Cardiology Annual Scientific Sessions during a late-breaking trial session by Dean Kereiakes, MD, Medical Director at The Christ Hospital Heart and Vascular Center and The Lindner Research Center in Cincinnati and the principal investigator for the PERSEUS clinical program. “We are very encouraged by the one-year data demonstrating positive safety and efficacy outcomes for the Taxus Element Stent and its innovative platinum chromium alloy,” said Dr. Kereiakes. “In my experience, the Taxus Element Stent offers increased flexibility, visibility and deliverability compared with currently available products. The PERSEUS data confirm that the proven Taxus drug and polymer combination has been successfully transferred to the Element platform with excellent performance and comparable safety.” The Taxus Element stent is designed specifically for coronary stenting. The novel stent architecture and proprietary platinum chromium alloy combine to offer greater radial strength and flexibility. The stent architecture helps create consistent lesion coverage and drug distribution while improving deliverability, which is enhanced by an advanced catheter delivery system. The higher density alloy provides superior visibility and reduced recoil while permitting thinner struts compared to prior-generation stents.1 The PERSEUS clinical program compares the TAXUS Element Stent to prior-generation stents in more than 1,600 patients in two parallel trials at 90 centers worldwide. The pivotal PERSEUS Workhorse trial is evaluating the safety and efficacy of the Taxus Element stent compared to Boston Scientific’s first-generation Taxus Express stent in 1,262 patients with de novo lesions. The prospective, randomized (3:1) trial met its primary endpoint of non-inferiority for target lesion failure2 (TLF) at 12 months with rates of 5.6% for the Taxus Element stent and 6.1% for the Taxus Express stent.3 The secondary endpoint of in-segment percent diameter stenosis at nine months as measured by quantitative coronary angiography (QCA) was also met. Workhorse results also demonstrated similar safety for the Taxus Element stent as demonstrated by low rates of major adverse cardiac events (MACE) and stent thrombosis. All components of MACE, including cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR) were similar to the Taxus Express stent control. A numerically lower rate of non-Q-wave MI for the Taxus Element stent resulted in lower overall MI (2.2 vs. 2.9%, p=0.48). Stent thrombosis rates using the Academic Research Coalition (ARC) definite/probable definition were statistically similar for the TAXUS Element Stent and the TAXUS Express Stent (0.4 and 0.3 %, p>0.99). Results were also presented from the PERSEUS Small Vessel trial, a single-arm study which compares the Taxus Element stent in 224 patients with small vessels (> or = 2.25 to The Taxus Element stent is an investigational device in the U.S. and is limited by applicable law to investigational use only and are not available for sale.
1. Based on bench testing. Data on file with Boston Scientific. 2. TLF is defined as ischemia-driven target lesion revascularization (TLR) or myocardial infarction/cardiac death related to the target vessel. Complete trial design at Allocco et al., Trials 2010, 11:1. 3. Bayesian probability of non-inferiority = 99.96 percent.
Siemens at ACC 2010: Interventional Cardiology and Cardiovascular IT SolutionsThe Artis zeego® is a multi-axis system that enables variable working height and unparalleled positioning, without impacting the laminar air flow field. The Artis zeego is part of the Artis zee® family. syngo® DynaCT Cardiac, available with all Artis zee systems, supports cross-sectional 3D images of the beating heart via rotational angiography. The Artis zeego is now available with small detector, which enables cardiologists to have optimized visualization of the heart while achieving steeper angles. A medical grade large display has a full-color, 56-inch screen where users can select their preferred screen layout for the planned procedure at tableside. The Artis zee family also now integrates with IZ3D, a new online quantitative measurement tool which provides high-speed quantification for accurate lesion measurement. Physicians can use the tool to assess a lesion’s diameter profile and the degree of stenosis via a 3D model of the vessel. This model can be rotated freely in space to eliminate foreshortening effects. syngo® Dynamics is Siemens’ multi-modality image viewing and archiving system. syngo Dynamics version 9.01 introduces new administrative tools to enhance the clinical experience, supports additional reductions in report turnaround time and offers real time display of key performance indicators (KPIs). Soarian® Quality Measures automates chart abstraction and helps expedite the submission of quality measures, as defined by the Centers for Medicare and Medicaid Services (CMS) and The Joint Commission. For cardiologists, Soarian Quality Measures automatically abstracts and presents the relevant evidence from the two heart-related CMS topics: acute myocardial infarction and heart failure. syngo.via2 places special focus on reading efficiency through automated case preparation and structured case navigation across multiple specialties, including cardiology. For further information, please visit: www.siemens.com/healthcare.
1. This information about this product is preliminary. The product is under development and not commercially available for sale in the U.S. and its future availability cannot be ensured. 2. syngo.via can be used as a standalone device or together with a variety of syngo.via-based software options, which are medical devices in their own rights.
Gold Nanoparticles Zap Plaque in ArteriesA new procedure using biophotonics and nanotechnology could offer a new treatment to reduce arterial plaque buildup, according to research presented at the American College of Cardiology’s 59th annual scientific session. A team of researchers based in Russia, with the cooperation of research labs in The Netherlands, used gold nanoparticles to successfully destroy arterial plaques. The trial was led by Sergey Kutepov, MD, and managed by Alexandr Kharlamov, MD, of the Urals State Medical Academy in Russia. In the trial, 27 patients were split up into three groups, including a saline control group of 10. Among the 17 patients with stable angina, one group received nanoparticles and near-infrared laser treatments and the second group received adult stem cells with intracellular nanoparticles and near-infrared laser. “This new treatment technique provides not only higher efficacy of plaque destruction, but also the absence of a foreign body in the artery after the procedure (as in stenting) leading to minimal complications such as restenosis,” Dr. Kharlamov said. “This research project highlights the potential of nano biotechnologies in modern cardiology and development of new invasive clinical approaches to improve the management of coronary artery disease, and enhance survival rate and quality of life in cardiac patients.” The first group had nanoparticles placed directly into the site of the plaque with a local delivery system (an ultrasound-mediated albumin-coated gas-filled microbubbles system with surface antibodies). In the second group, nanoparticles were placed intracellularly in circulating progenitor cells, which are similar to adult stem cells, and then planted at the site of the plaque. Both groups received silica-gold nanoparticles, with a radius of just 80 nanometers. Prior to intervention, the coronary artery disease of both groups was investigated using intravascular ultrasound mapping. Three days after the nanoparticles were implanted, they were exposed to radiation from a laser to heat the particles. Researchers exposed the plaque to the laser using a catheter and under the protection of antithrombotic therapy. The result was that the plaques were partially destroyed. Magnetic resonance temperature imaging demonstrated that plaques reached temperatures 38.1±6.5 Celsius (about 100 degrees Fahrenheit) within 4-6 minutes of being exposed to the laser. Slightly more than 97% of the plaque was destroyed in the group with nanoparticles placed in circulating progenitor cells and 64.1% of plaque was destroyed in the group that had the local delivery system. Blood flow was restored in 100% of the patients. Intravascular ultrasound showed total degradation and loss of plaque’s typical structure in the progenitor cells group. Destruction of plaque’s fibrous cap was observed in 100% of patients. The team experienced no severe complications at a 12-month follow-up period after the procedures. Intravascular ultrasound showed restoration of the blood vessel structure in 12 months after the procedure. Also, none of the patients experienced long-term cases of restenosis. However, on the basis of the previous experimental data, fatal atherothrombosis is one of the most probable complications in these patients, limiting some clinical perspectives. “While the findings of our research study are exciting and the potential for nanobiotechnology in advancing cardiac care, the small sample size of our study does necessitate larger studies to ensure the efficacy and safety of these procedures,” Dr. Kharlamov said.
Inadequate Response to Clopidogrel Leads to Higher Incidence of Major Adverse Cardiac Events in Patients Who have Undergone PCIResults suggest increased need for quantifying patient response to clopidogrel through point-of-care testing Accumetrics, Inc., developer and marketer of the VerifyNow® System, a point-of-care system for measuring platelet reactivity to multiple antiplatelet agents, announced the presentation of a 2,000 patient meta-analysis examining patient response to antiplatelet therapy after percutaneous coronary intervention (PCI). Data from the patient-level meta-analysis show that individuals with an inadequate response to clopidogrel have a higher incidence of major adverse cardiac events. Somjot S. Brar, MD, director of vascular medicine and staff interventional cardiologist at Kaiser Permanente, presented the results at the American College of Cardiology’s 59th annual scientific session. “Our data suggest that approximately 35% of patients undergoing PCI have poor response to clopidogrel, which is consistent with previous findings,” said Dr. Brar. “These patients with inadequate response identified by the VerifyNow test may have twice the risk of ischemic events or death.” The analysis showed results consistent with previous publications on the clinical utility and importance of assessing response to antiplatelet therapy using the VerifyNow P2Y12 platelet function test, including the recently published POPular trial (JAMA, Feb 2010). Dr. Brar continued, “These data could not have come at a more appropriate time based on the FDA’s recent warning that genetic differences may reduce the effectiveness of clopidogrel. Many studies, including our own, have repeatedly shown that there are several factors, including genetics, concomitant medications and pre-existing conditions such as diabetes, that influence the effectiveness of clopidogrel and ultimately clinical outcomes.” Platelet function tests, such as the VerifyNow P2Y12 Test, measure the combined effect of all of these factors.
Abbott Announces Positive Data From ABSORB Trial on Its Bioresorbable Vascular Scaffold TechnologyNew Data From Second Phase Shows No Blood Clots, No Repeat Procedures and Very Low MACE Abbott announced positive 30-day results from the first 101 patients enrolled in the second phase of the ABSORB trial. Patients treated with Abbott’s bioresorbable vascular scaffold (BVS), under clinical investigation in Europe, demonstrated no cases of thrombosis, no need for repeat procedures (ischemia-driven target lesion revascularization) and a very low rate of major adverse cardiac events (2.0%) at 30 days. The first phase of the ABSORB trial generated positive data on 30 patients out to three years. Data from the second phase of the trial was presented at the American College of Cardiology’s 59th annual scientific session. “The positive 30-day results reaffirm my belief that a device that bioresorbs, or disappears, into the body after restoring blood flow is the next logical step in the treatment of cardiovascular disease,” said Patrick W. Serruys, MD, PhD, professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, the Netherlands, and principal investigator for the ABSORB trial. “The continuing positive results of the ABSORB trial and the clinical benefits demonstrated to date by Abbott’s bioresorbable technology show promise that a bioresorbable scaffold is on its way to becoming a clinical reality and will be the next revolution in interventional cardiology.” This second phase of the ABSORB clinical trial (Cohort B) enrolled 101 patients from 12 centers in Europe, Australia and New Zealand, and incorporates device enhancements designed to improve deliverability and vessel support. Abbott’s investigational BVS is made of polylactide, a proven biocompatible material that is commonly used in medical implants, such as dissolving sutures. The ABSORB trial is a prospective, non-randomized (open label), two-phase study that enrolled 131 patients from Australia, Belgium, Denmark, France, The Netherlands, New Zealand, Poland and Switzerland. Key endpoints of the study include assessments of safety – MACE and treated site thrombosis rates – at 30 days; six, nine, 12, 18 and 24 months; with additional annual clinical follow-up for up to five years, as well as an assessment of the acute performance of the bioresorbable vascular scaffold, including successful deployment of the system. Other key endpoints of the study include imaging assessments by angiography, intravascular ultrasound (IVUS), optical coherence tomography (OCT), and other state-of-the-art invasive and non-invasive imaging modalities at six, 12, 18 and 24 months. Abbott’s bioresorbable technology delivers everolimus, a drug that inhibits tissue proliferation. Everolimus, developed by Novartis Pharma AG, is a proliferation signal inhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on its vascular devices. Everolimus has been shown to inhibit treated site neointimal growth in the coronary vessels following vascular device implantation, due to its anti-proliferative properties.
New Guidelines Aim to Prevent Unnecessary Death from Thoracic Aortic DiseaseMulti-disciplinary team of experts weighs in on diagnosis and management When actor John Ritter died suddenly in 2003 from a tear in his thoracic aorta, that tragedy brought attention to a rare but deadly condition that takes the lives of an estimated 10,000 Americans each year. Now, new clinical guidelines spearheaded by the American College of Cardiology (ACC) and the American Heart Association (AHA) not only offer new recommendations for the diagnosis and management of thoracic aortic disease (TAD), they deliver a powerful message to physicians and patients: Early diagnosis and treatment can save lives. “If thoracic aortic disease can be detected early and managed, it gives us the opportunity to select patients for surgical or endovascular repair when the patient is stable,” said Loren F. Hiratzka, MD, who chaired the guidelines writing committee and is the medical director of cardiac surgery for TriHealth, Inc. (Bethesda North and Good Samaritan Hospitals) in Cincinnati, OH. “The results of treatment for stable disease are far better than for acute — and often catastrophic — aortic rupture or dissection.” The new guidelines appear in the April 6, 2010, issues of the Journal of American College of Cardiology (JACC) and Circulation: Journal of the American Heart Association, as well as on websites of the ACC (www.acc.org) and the AHA (www.americanheart.org). They were developed in collaboration with the American Association for Thoracic Surgery (AATS), American College of Radiology (ACR), American Stroke Association (ASA), Society of Cardiovascular Anesthesiologists (SCA), Society for Cardiovascular Angiography and Interventions (SCAI), Society of Interventional Radiology (SIR), Society of Thoracic Surgeons (STS), and Society for Vascular Medicine (SVM). The American College of Emergency Physicians (ACEP) and the American College of Physicians (ACP) were also represented on the writing committee. Recent scientific and clinical advances drove the development of guidelines to aid physicians in the diagnosis and management of aortic dissection, aortic aneurysm and other forms of TAD, said Kim A. Eagle, MD, director of the University of Michigan Cardiovascular Center in Ann Arbor and co-author of the guidelines. “We now have a deeper understanding of the genetic underpinnings of TAD, and we continue to expand our knowledge in this area,” he said. “There have been rapid advances in noninvasive imaging. Medical therapy is much better. Open surgical techniques with anesthesia have improved dramatically. We can even use endovascular approaches in some patients.” Risk factors for TAD include poorly controlled high blood pressure, advancing age, male gender, atherosclerosis, inflammatory diseases that damage the blood vessels, and certain genetic conditions that weaken connective tissue, such as Marfan syndrome. In addition, people whose aortic valve has only two leaflets (bicuspid valve) instead of the normal three leaflets may be at increased risk for an aortic aneurysm. Pregnancy, intense weight lifting and cocaine use increase the risk of aortic dissection. One of the most important messages in the guidelines is that TAD often runs in families. As a result, family history is a critical tool for uncovering undiagnosed cases of TAD. Additional highlights from the TAD guidelines include: • Imaging of the thoracic aorta by computed tomography (CT), magnetic resonance imaging (MRI) or, in some cases, echocardiography is the best way to detect TAD and determine future risk. A chest x-ray alone is not sufficient. • Patients with genetic conditions that increase the risk of TAD should have aortic imaging at the time of diagnosis to establish the size of the aorta, with periodic follow-up imaging thereafter. • All patients with a bicuspid aortic valve should be evaluated to determine whether the aorta is dilating, or widening. • The symptoms of acute aortic dissection, which can mimic those of a heart attack or another cause of chest pain, often make it difficult to arrive at a prompt diagnosis and may delay life-saving treatment. Physicians should keep aortic dissection in mind when asking questions about medical history, family history, and the type and pattern of pain, and when examining the patient. • Aortic dissection involving the ascending aorta is a life-threatening emergency that should be treated surgically. • Aortic dissection involving the descending thoracic aorta may often be managed with medications that control the blood pressure and heart rate, unless life-threatening complications develop. Additional medical therapy may include statins to lower elevated blood cholesterol levels. • Minimally invasive endovascular techniques are an option in some patients with aneurysm or dissection of the descending thoracic aorta. • All immediate relatives of a patient with thoracic aortic aneurysm or dissection, or a bicuspid aortic valve, should be evaluated by a cardiovascular physician and undergo aortic imaging to measure the size of the aorta and identify asymptomatic disease. Not all health insurers pay for aortic imaging in high-risk asymptomatic patients, particularly based on family history, Dr. Hiratzka said. “I hope the new guidelines will change that,” he said. “It could be lifesaving.”
Cardiac Events May be Related to Stock Market TrendsHeart attack frequency and stock market fluctuations may be related, according to research presented at the American College of Cardiology’s 59th annual scientific session. The 2008-2009 U.S. stock market crisis led researchers to examine whether the effects extend beyond people’s wallets, possibly increasing the likelihood of heart attacks among those with ischemic heart disease. In this pilot observational study, authors report results for patients who came to the Duke Hospital catheterization lab between January 2006 and July 2009 using data from the Duke Databank for Cardiovascular Disease. To be included, patients had to have suffered a heart attack within three days prior to cardiac catheterization. Data was then plotted against the stock market daily values during the same period of time. “In analyzing our local patient population undergoing catheterization during the recent period of increased volatility in the stock market, we found that when stock market values decreased, heart attacks seemed to increase, and then decreased when stock trends improved,” said Mona Fiuzat, PharmD, Duke University Medical Center, Durham, N.C., and lead investigator of the study. “While more and larger studies are needed to examine the reason for these findings, it’s important for healthcare providers to be aware of social stressors that may potentially affect their patients.” Despite previous studies showing that mental stress and traumatic events, such as those associated with 9/11 and Hurricane Katrina, may increase the risk of cardiac events including heart attacks, there is limited data looking specifically at a correlation between economic trends and cardiovascular events, according to researchers. Possible psychological or environmental contributing stressors include alterations in cell function, changes in platelet reactivity, stress hormone changes, immune/inflammatory changes, as well as social support factors. Authors stress that these are preliminary findings from a local database that need validation and confirmation in a larger, more inclusive cohort. The researchers are planning a larger extended study.
Rheolytic Thrombectomy Before Stenting Found Superior to Stenting Alone in Acute MI Patients: JETSTENTThe randomized, prospective JETSTENT trial* enrolled 501 patients at eight sites across Europe and South America between December 2005 and September 2009 to determine how use of a rheolytic thrombectomy system would affect myocardial reperfusion and clinical outcomes for patients with acute ST-segment elevation myocardial infarction. The trial’s primary endpoints were ST-segment resolution at 30 to 45 minutes post-procedure and final infarct size at 30 days. Clinical endpoints included a composite of death, heart attack, target vessel revascularization, and stroke at one, six, and 12 months, as well as a composite of death and readmission for congestive heart failure at 12 months. Significantly more patients receiving rheolytic thrombectomy in addition to direct stenting experienced resolution of their ST-segment elevation in the designated time frame than those patients receiving stenting alone, at 85.8% and 78.8%, respectively. Additionally, while no significant differences were revealed in infarct size as assessed by 1-month scintigraphy (median infarct size was 11), the researchers found a value of 6% in the thrombectomy arm and 12.6% in the direct stenting alone arm. The researchers also found a significant decrease in major cardiovascular adverse events both at 1 month and at 6 months for patients randomized to receive rheolytic thrombectomy than patients in the direct stenting alone arm (3.1% versus 6.9% and 11.9% versus 20.6%, respectively). The researchers did not find a significant difference between the study’s other surrogate endpoints, including myocardial blush grade and the corrected TIMI frame count.