Posts Tagged ‘Cardiology’

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St. Luke’s unveils Discovery IGS 730 Hybrid OR from GE Healthcare

St. Luke’s unveils Discovery IGS 730 Hybrid OR from GE Healthcare

St. Luke’s University Hospital unveiled the Discovery IGS 730 Hybrid OR from GE Healthcare today, becoming the first hospital in the United States to offer this exciting new technology. This interventional suite combines the advanced imaging world and the surgical world into the Operating Room. The system received FDA clearance in February 2012.

St. Luke’s University Health Network clinicians traveled to Buc, France three years ago to provide surgical insight that served in the development of the first GE Hybrid OR which comes equipped with laser-guided navigation. The system is completely mobile and can be programmed to move widely within the operating room, giving physicians the ultimate in precision and flexibility during even the most complex procedures.

St. Luke’s and GE Healthcare – a 25-year relationship

“Together with GE healthcare engineers and, from St. Luke’s University Health Network, vascular surgeon Tim Oskin, MD, Section Chief of Vascular Surgery; Raymond Durkin, MD, Chief of Cardiology; and Carol McGee, Supervisor of Interventional Radiology, we are delighted to have been among those to have contributed to the product development of the Discovery IGS 730,” says Hal Folander, MD, Chairman of the Radiology Department and Section Chief of Interventional Radiology at St. Luke’s University Health Network.

“Having been part of the development process from the ground up, we know firsthand how extremely agile and capable this new technology truly is,” says Dr. Folander. “I would say this is probably one of the most revolutionary interventional projects that I’ve seen. The innovation is equivalent to or greater than the invention of the flat panel technology for interventional procedures.”

“We are thrilled to have St. Luke’s be the first U.S. site to use the Discovery IGS 730,” says Suzanne Winter, General Manager, United States and Canada, GE Healthcare, Detection & Guidance Solutions. “With their medical staff we have truly found a key partner willing to progress alongside us when it comes to technological advancements. With this, we are well positioned to address the growing trend in the United States for minimally invasive procedures and we are grateful to have St. Luke’s be our national reference site for future customers, surgeons and interventionalists.”

About the technology

The Discovery IGS 730 Hybrid OR is neither floor- nor ceiling-mounted, and enables full patient access. It has the mobility of a C-arm with the power and image quality of a fixed system. This laser-guided, motorized mobile gantry creates an interventional environment without boundaries. It allows complete access to the patient and multiple parking possibilities, while helping maintain sterility for a flexible and secure OR environment. The unique gantry comes with a new wide bore design, which allows for steep angles ease in 3D acquisition, especially for large patients. Thanks to its flexibility, multiple, or combined endovascular and open procedures, can be done in one room at one time when necessary.

“A tether housing the electrical connection to the unit allows the system to float, providing an additional degree of freedom,” says Dr. Folander. “Its flexibility means the unit can also be moved completely out of the way and into multiple positions.”

Aside from its supreme flexibility, the system also provides a large field, or flat panel, for precise 3D acquisition, according to Dr. Folander. The wide C-arm can help accommodate larger patients; and multiple, or combined procedures can be done in one room at one time if necessary.

“Simply put, it’s a sophisticated interventional environment without boundaries that will enhance how we do complex vascular and cardiac procedures and even trauma cases,” says Dr. Folander. “It could be a true time saver and potentially a life saver, when reverting to surgery, as it could prove especially invaluable in emergency situations when every second counts.”

Complex procedures to be performed in the Hybrid OR

Specialists using the hybrid OR at St. Luke’s include vascular surgeons, cardiothoracic surgeons, interventional cardiologists, cardiac electrophysiologists and interventional radiologists. Procedures to be performed in this new environment include endovascular repair of thoracic and abdominal aortic aneurysms; pacemaker lead extractions; transcatheter aortic valve replacement (TAVR); trauma cases requiring multiple, or combined, procedures. Non-trauma patients requiring combined procedures or surgeries will also be candidates for procedures in the hybrid OR at St. Luke’s.

“In designing the Discovery IGS 730, it was always our goal to provide the latest in OR efficiency – with high-precision imaging capability and exceptional in-room mobility. This solution aims to accommodate a wide range of minimally invasive and surgical procedures. Due to the technological advancement and flexibility of the system we hope it will allow our customers to explore and discover new ways within the OR room,” says Chantal Le Chat, General Manager, GE Healthcare, Detection & Guidance Solutions. “It is clear that St. Luke’s shares this goal and as such represents a great partner.”

The TAVR procedure will be performed in the new Hybrid OR at St. Luke’s by cardiothoracic surgeon Stephen Olenchock, DO, Section Chief, Cardiovascular Surgery, St. Luke’s University Health Network. This leading-edge procedure is approved for patients who are not candidates for open heart surgery procedures, because the risk of an open heart procedure would be too great. Earlier this year, St. Luke’s became one of the first institutions in the country to offer TAVR with the Edwards Sapien valve due to exceptional outcomes and a multidisciplinary team approach.

TAVR is an alternative to open heart surgery for valve replacement in which a catheter is guided through a small incision in the groin and then advanced through the femoral artery. The valve is deployed via catheter. TAVR received FDA approved in November 2011. This procedure is approved for patients who are not candidates for open heart surgery procedures, because the risk of an open heart procedure would be too great. To qualify for TAVR, patients cannot have severe buildup of plaque in the arteries.

Benefits of TAVR include a shorter hospital stay; less anesthesia; less risk of infection; and a faster recovery. Patients avoid a cardiopulmonary bypass, or the use of the heart/lung machine, since the heart continues to beat during the procedure. With the new valve in place, blood flow occurs immediately.

A history of introducing medical innovations

St. Luke’s University Health Network is a show site for GE Healthcare and continues to be a regional leader in offering advanced medical technologies and innovations. In 2002, St. Luke’s was first in the world to offer the GE Innova 4100 large-format digital flat panel detector, providing detailed, real-time fluoroscopic images of human anatomy for radiological procedures. For the past 10 years, the technology has helped physicians treat a wide variety of medical disorders, including peripheral vascular, cardiovascular and neurological diseases and uterine fibroids, without major surgery.

Dr. Folander participated in the study of the Innova 4100, to then become the first user of the system in the US. St. Luke’s was also the first hospital in the region to offer Computed Tomography (CT) scanner in 1978, an early-generation CT scanner from GE Healthcare.

Source : http://www.news-medical.net/news/20121117/St-Lukes-unveils-Discovery-IGS-730-Hybrid-OR-from-GE-Healthcare.aspx

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Novel electrotherapy reduces energy needed to re-establish normal rhythm in the heart

Novel electrotherapy reduces energy needed to re-establish normal rhythm in the heart

Implantable defibrillators currently on the market apply between 600 and 900 volts to the heart, almost 10 times the voltage from an electric outlet, says Ajit H. Janardhan, MD, PhD, a cardiac electrophysiology fellow at the Washington University’s School of Medicine.

After being shocked, he says, some patients get post-traumatic stress disorder. Patients may even go so far as to ask their physicians to remove the defibrillator, even though they understand that the device has saved their lives.

The huge shocks are not only unbearably painful, they damage the heart muscle and have been shown in many studies to be associated with increased mortality. In an advance online edition of the Journal of American College of Cardiology, Janardhan and Igor Efimov, PhD, professor of biomedical engineering in the School of Engineering & Applied Science, report on a low-energy defibrillation scheme that significantly reduces the energy needed to re-establish a normal rhythm in the heart’s main chambers.

They hope this electrotherapy will be much less painful than shocks from existing implantable defibrillators, and may even fall beneath the threshold at which patients begin to perceive pain.

The team has just received a National Institutes of Health grant to develop a prototype low-energy defibrillator for humans and plan to begin clinical trials of the device shortly.

Losing the beat

The lub-dub of the heartbeat begins with an electrical impulse generated by the sinoatrial node, a group of cells on the wall of the right atrium that is the heart’s natural pacemaker.

Spreading through conductive pathways in the heart, the electrical signal first causes the two upper chambers of the heart (the atria) to contract, and then, a split second later, the two lower chambers (the ventricles), coordinated motions that efficiently pump blood to the rest of the body.

The synchronized squeezing of a normal heartbeat is called sinus rhythm, after the node that triggers it.

The rhythm can go wrong in many different ways, but the real killer is ventricular tachycardia. Ventricular tachycardia is an abnormal heart rhythm that starts in the ventricles rather than from the sinoatrial node, and that causes the heart to beat at a rate too fast (tachy is Greek for rapid or fast) to efficiently pump blood to the rest of the body.

Moreover, the rapid heartbeat can degenerate precipitously into ventricular fibrillation, or the loss of all rhythm, says Efimov. During ventricular fibrillation the uncoordinated contraction of heart muscle prevents the heart from pumping blood at all, and without immediate intervention, death quickly follows.

Most people who develop ventricular tachycardia and ventricular fibrillation outside the hospital die, says Janardhan, but studies show that if we implant a defibrillator in patients with a weak heart that does not pump as strongly as it should, we can significantly reduce mortality.

Restarting the rhythm

There are really only three therapies for ventricular tachycardia, Efimov says. One is drugs that reduce the likelihood of tachycardia, but drugs are often ineffective.

The second is ablation, or the deliberate creation of nonconductive scar tissue within the heart that blocks abnormal conductive patterns and redirects electrical activity to more normal pathways.

The major problem with ablation, says Efimov, is recurrence. It’s a temporary measure, not a cure. Patients typically need additional treatment within five years.

The third therapy is an implantable cardioverter defibrillator, or ICD. These devices are placed beneath the skin in the chest and monitor the rate and rhythm of the heart. If they detect ventricular tachycardia, they try to break the rhythm by pacing the heart at a rate faster than its intrinsic rate, a strategy anti-tachycardia pacing.

Anti-tachycardia pacing is very low energy, so low that patients may not even sense it. But it is relatively ineffective when the heart is beating 200 time per minute or faster. At these higher rates, the ICS zaps the heart with a strong electrical shock that resets it and, with luck, allows the pacemaker node to restart it with a normal rhythm.

A novel electrotherapy

The scientists knew from earlier experiments that the voltage needed to shut down ventricular tachycardia depended on the timing of the shock. This led them to ask whether a sequence of multiple, closely timed low-voltage shocks might be more effective than a single high-voltage shock, and be less sensitive to timing.

Indeed it turned out that if they shocked the heart multiple times they could reduce the peak shock amplitude from well over 200 volts to 20 volts, timing no longer mattered, and the therapy worked even if the ventricular tachycardia was very rapid.

Although this electrotherapy involves multiple shocks, the total energy it delivers is still lower than that of a single large shock, roughly 80 times lower.

Why do multiple shocks work better? Arrhythmias generate electrical wave vortices – little electrical tornadoes in the heart – and it is these vortices, or re-entrant circuits, that make the heart beat too fast and prevent it from pumping properly.

But immediately after it contracts, heart muscle goes through a refractory, or unresponsive, period during which it does not respond to electrical stimulation. The multiple shocks may do a better job of extinguishing the re-entrant circuits by creating an area of unresponsive muscle into which the re-entrant wavefront -the electrical tornado – crashes, the scientists suggest.

Relocating the Electrodes

Defibrillators now on the market apply shocks between the right ventricle (RV) and an “active can” located above the chest wall, below the collarbone. The shocks are painful in part because they pass through the chest wall muscle and sensory nerves.

The investigators found they could reduce peak shock voltages by an additional 50 percent if they applied shocks between the RV and coronary sinus (CS), a vessel that collects deoxygenated blood from the heart muscle, rather than through the chest wall. Less energy was required because the shocks were confined to the heart itself, and for the same reason they were also less painful.

In an earlier paper, Efimov’s student Wenwen Li, PhD, now at St. Jude Medical, had reported on a similar strategy for restoring the rhythm of the atria, the two upper chambers of the heart, for a less serious but more common rhythm abnormality.

The team has already developed the first low-energy atrial defibrillator, which will soon be entering clinical trials. They hope for similarly rapid progress with the ventricular defibrillator.

“We think this technology can and will be implemented soon,” says Janardhan. “There’s a lot of cardiac research that may pan out 20 or 30 years from now,” he says, “but as a physician I want something that can help my patients now.”

Source : http://www.news-medical.net/news/20121113/Novel-electrotherapy-reduces-energy-needed-to-re-establish-normal-rhythm-in-the-heart.aspx

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Landmark study could lead to fewer inappropriate shocks from implanted defibrillators

Landmark study could lead to fewer inappropriate shocks from implanted defibrillators

Loyola University Medical Center is among the centers participating in a landmark study that could lead to fewer inappropriate shocks from implanted defibrillators.

Implanted defibrillators save lives by shocking hearts back into a normal rhythm. But sometimes a defibrillator can go off when it’s not necessary, delivering a shock that feels like a kick in the chest.

The study found that reprogramming defibrillators to be less sensitive to irregular heart rhythms reduced the number of inappropriate shocks, while also reducing mortality. The study was presented at a meeting of the American Heart Association Scientific Sessions and is being published in the New England Journal of Medicine.

“Inappropriate shocks can be painful and psychologically traumatic to patients,” said cardiologist Dr. Peter Santucci, medical director of Loyola’s Implant Device Program. “It’s important to reduce these shocks, and results of this study will help us to do this, while also potentially improving patients’ survival.”

Santucci enrolled Loyola patients in the multi-center international trial. Dr. David Wilber, director of Loyola’s Cardiovascular Institute, is a co-author of the paper.

The trial is known as MADIT-RIT (Multicenter Automatic Defibrillator Implantation Trial – Reduce Inappropriate Therapy.) First author is Dr. Arthur J. Moss of the University of Rochester Medical Center.

An implantable cardioverter defibrillator (ICD) is about the size of a pocket watch, and is implanted below the collarbone. Wire leads connect to the heart. The device is designed to protect against tachyarrhythimas — quivering, superfast heartbeats that prevent the heart from pumping blood effectively.

When the heart goes into a tachyarrhythimia, the ICD’s pacemaker is activated. If the pacemaker fails to restore a normal rhythm, the ICD then delivers a powerful electric shock that jolts the heart back into a normal rhythm. But previous research, cited in the new paper, found that ICDs are inappropriately activated in between 8 percent and 40 percent of patients.

Under conventional programming, an ICD may be activated if the heart beats 170 to 199 beats per minute for 2.5 seconds or at least 200 beats per minute for 1 second. If the heart rate does not slow within 5 to 10 seconds, a shock may be delivered.

The study included 1,500 patients, who were randomly assigned to three groups. The first group had ICDs with conventional programming. In the second group, the ICDs would not activate unless the heart beat at least 200 beats per minute. In the third group, the ICDs were programmed to have longer delays before activation (for example, 60 seconds delay when the heart beats 170 to 199 beats per minute).

After an average follow-up of 1.4 years, patients in the second group had a 79 percent reduction in first-time inappropriate ICD activation. Patients in the third group had a 76 percent reduction in first-time inappropriate activation.

There was a 55 percent reduction in deaths in the second group and a 44 percent reduction in deaths in the third group.

Wilber is a professor and Santucci is an associate professor in the Department of Medicine, Division of Cardiology of Loyola University Chicago Stritch School of Medicine.

source : http://www.news-medical.net/news/20121108/Landmark-study-could-lead-to-fewer-inappropriate-shocks-from-implanted-defibrillators.aspx

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Atherotech VAP Lipid Panel demonstrates accuracy in personalized heart disease risk assessment

Atherotech VAP Lipid Panel demonstrates accuracy in personalized heart disease risk assessment

Researchers using the Atherotech VAP® Lipid Panel demonstrated the comprehensive lipid profile’s accuracy in risk stratification through subclass measurement in two abstracts presented today at the American Heart Association (AHA) Scientific Sessions 2012. The VAP Lipid Panel measured cholesterol subclasses in Framingham and TRIUMPH populations, highlighting the lipid panel’s accuracy and potential for improved outcomes in personalized heart disease risk assessment compared to the standard lipid panel, which is inadequate and inaccurate in select patients.

“These findings from TRIUMPH indicate that the more granular assessment of HDL subclasses adds important information beyond that provided by total HDL cholesterol levels alone”

The poster abstract #18939 Impact of LDL Pattern on Risk for CHD in the Framingham Offspring Population presented by study lead author Peter P. Toth, M.D., demonstrated that LDL pattern B (small, dense LDL particles) as measured by the VAP Lipid Panel is an independent risk factor for coronary heart disease (CHD), including acute myocardial infarction (AMI) — or heart attack — and sudden cardiac death.

“We know that traditional risk factors do not fully explain the risk for CHD events,” said Toth, Director of Preventative Cardiology at CGH Medical Center in Sterling, Illinois, and a member of Atherotech’s Medical Advisory Board.

“The results presented today are important because they suggest that LDL subclass measurement, when added to simple LDL concentration, conveys independent CHD risk assessment information leading to more accurate risk stratification and improved outcomes,” said Toth, who has authored or coauthored more than 200 publications and is also president of the National Lipid Association.

LDL can be separated into two phenotypes called pattern A and pattern B. The LDL pattern A subclasses LDL1,2 are composed of larger, more buoyant LDL particles. LDL pattern B subclasses LDL3,4 are composed of smaller, more dense LDL particles, which penetrate the vascular wall more easily.

A second abstract, #16722, HDL Cholesterol Subclasses and Mortality after Acute Myocardial Infarction: The TRIUMPH Prospective Multi-Center Registry, was the subject of an oral presentation by Seth S. Martin, M.D., Fellow, Division of Cardiology, Johns Hopkins Hospital. Using direct measurement of HDL cholesterol subfractions (HLD2 and HDL3) provided by the VAP Lipid Panel, the study showed a 50% relative increase in mortality risk among study participants at two years after hospitalization in the lowest tertile of HDL3 cholesterol versus the middle tertile after adjusting for relevant confounders in the fully adjusted model.

“These findings from TRIUMPH indicate that the more granular assessment of HDL subclasses adds important information beyond that provided by total HDL cholesterol levels alone,” said Martin. “After myocardial infarction, risk information captured in HDL2 and HDL3 cholesterol does not appear to be the same. Our findings speak to the complexity of HDL and help inform this rapidly evolving and intriguing HDL story.”

Study authors examined data from 2,465 patients from the TRIUMPH registry to determine the relative prognostic importance of HDL subclasses (larger, more buoyant HDL2 and smaller, more dense HDL3) after AMI. The Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction Patients’ Health Status (TRIUMPH) study is a prospective, 24-center U.S. study of AMI outcomes.

VAP Lipid Panel Research highlights importance of LDL and HDL subclass identification in heart disease risk assessment and mortality.

“Both presentations add to our knowledge of residual risk and the impact that cholesterol subfractions can have on cardiovascular risk assessment and prognosis,” said Chief Medical Officer Michael E. Cobble, M.D. “These results will lead to more research that further clarifies the role of lipid subfraction measurement, beyond the capabilities of the basic lipid panel, leading to improved risk identification and management.”

source : http://www.news-medical.net/news/20121108/Atherotech-VAP-Lipid-Panel-demonstrates-accuracy-in-personalized-heart-disease-risk-assessment.aspx

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EUROECHO 2012 reveals how imaging improves early diagnosis of atherosclerosis

EUROECHO 2012 reveals how imaging improves early diagnosis of atherosclerosis

“Atherosclerosis is the leading cause of cardiovascular disease and the leading killer in Europe,” said Professor Patrizio Lancellotti, President-Elect of the EACVI and Chairman of the EUROECHO Scientific Programme Committee. “Many of these deaths could be averted by diagnosis at a preclinical stage or early after the onset of symptoms.”

He added: “Echocardiography and other imaging modalities play an important role in the diagnosis of atherosclerosis. For example, many of the features associated with a high risk plaque can now be probed by novel imaging techniques such as ultrasound imaging of carotid intima-media thickness, contrast enhanced ultrasound, magnetic resonance imaging (MRI) and positron emission tomography (PET).”

Professor Luigi Badano, EACVI President, continued: “We now have the tools to image the early signs of atherosclerosis without waiting for symptoms or clinical manifestations.”

This breakthrough is the focus of the first theme of the congress, imaging atherosclerosis.

EUROECHO 2012 is one of the largest echo and imaging meetings in the world and is expected to attract more than 3,000 cardiologists, internists, cardiac surgeons and sonographers from over 90 countries. This year promises four days of the latest science and treatment monitoring options in cardiovascular imaging, with an abundance of news stories for journalists. The full scientific programme is available here.

Nearly 700 original scientific abstracts will be presented by international scientists on hot topics such as increasing the viability of hearts for transplantation, cardiovascular risks in patients with HIV, the links between obstructive sleep apnea and heart disease, and assessing the cardiac damage induced by cancer drugs.

“The aim is to create an exciting forum for both clinicians and scientists to present and discuss the most up-to-date research and clinical findings in echocardiography and cardiovascular imaging,” said Professor Lancellotti. “The most exciting part of the meeting will be dedicated to how new technology on echocardiography (contrast echo, tissue Doppler imaging, 3D echo, stress echocardiography) and other modalities can enter the clinical arena in the interest of the patient.”

The second theme of the congress is non-invasive cardiovascular imaging techniques and outcome. Professor Lancellotti said: “A rapid echo-guided puncture of a pericardial effusion can save the life of a patient with cardiac tamponade.”

He added: “Most often, imaging outcome is derived from risk stratification and detection of any cardiac involvement at an earlier stage. Early detection is of importance because early intervention may slow down the progression of the disease or appropriate follow-up monitoring can be started.”

New echocardiographic techniques such as tissue Doppler imaging and 2D speckle tracking of myocardial dysfunction enable detection of subtle abnormalities in left ventricular function before any changes in ejection fraction (used to define a normal function). Imaging can also be used to detect cardiotoxicity of cancer drugs. Professor Lancellotti said: “We cannot necessarily prevent the cardiotoxicity but we can detect the cardiac effect earlier and then adapt the treatment.”

Special sessions have been organised for delegates under the age of 35 by the EACVI Club 353 committee. EACVI membership in this age group has increased from 5% to 25% over the past year. For the first time this year there will be two young investigator awards, one for clinical research and one for basic research.

Professor Badano concluded: “Today it is not just echocardiography that can improve patient outcome, but also magnetic resonance imaging, computed tomography and nuclear cardiology. Cardiovascular imaging can be used to improve diagnosis, guide interventional procedures and assess the results of cardiac surgery.”

Source : http://www.news-medical.net/news/20121108/EUROECHO-2012-reveals-how-imaging-improves-early-diagnosis-of-atherosclerosis.aspx

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Mesh-covered stent improves restoration of blood flow after PCI in heart attack patients

Mesh-covered stent improves restoration of blood flow after PCI in heart attack patients

A clinical trial found that the use of a next generation, micronet, mesh-covered stent demonstrated improved restoration of blood flow to heart tissue, compared to the use of either bare-metal or drug-eluting stents in heart attack patients undergoing angioplasty. Results of the MASTER trial were presented today at the 24th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium and will appear in the November 6th issue of the Journal of the American College of Cardiology. Sponsored by the Cardiovascular Research Foundation, TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine.

The lack of sufficient restoration of blood flow after an angioplasty (percutaneous coronary intervention) in heart attack patients is a common issue, and can result in increased size of the affected heart tissue, as well as death. The MASTER trial tested a new stent, the MGuard stent that uses a stent covered in a micronet mesh that is designed to prevent or reduce downstream embolization by holding plaque or thrombus in place against the wall of the blocked artery.

Between July 22, 2011 and May 29, 2012, 433 heart attack patients were enrolled and randomized at 50 sites in nine countries. The median age was 59; 24 percent were female. 217 patients received the new stent and 216 patients receiving either a drug-eluting stent (DES) or bare-metal stent (BMS) were in the control group.

The primary endpoint was the rate of complete (?70 percent) ST-segment resolution (STR) at 60-90 minutes following the procedure. In the group of patients with the mesh-covered stent, the rate of compete ST-segment resolution was 57.8 percent; in the control group, the rate was 44.7 percent.

“Among heart attack patients undergoing primary percutaneous coronary intervention, the micronet, mesh-covered stent compared to conventional bare-metal and drug-eluting stents resulted in superior rates of epicardial coronary flow and complete ST-segment resolution,” said study chairman, Gregg W. Stone, MD. Dr Stone is Professor of Medicine at Columbia University College of Physicians and Surgeons and Director of Cardiovascular Research and Education at the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center.

“A larger randomized trial is warranted to verify these findings, and determine whether these benefits result in reduced infarct size and/or improved clinical outcomes,” said Dr. Stone.

Source : http://www.news-medical.net/news/20121025/Mesh-covered-stent-improves-restoration-of-blood-flow-after-PCI-in-heart-attack-patients.aspx

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Combining distal protection devices with nicardipine improves post-PCI outcomes

Combining distal protection devices with nicardipine improves post-PCI outcomes

Researchers at Thomas Jefferson University Hospital have shown that combining distal protection devices with the prophylactic use of the drug nicardipine is more effective at preventing life-threatening complications following a percutaneous coronary intervention (PCI) (angioplasty, stenting) on patients who have undergone previous bypass surgery than distal protection devices alone.

Their findings will be presented on Tuesday, October 23rd, at 8 a.m. at the Transcatheter Cardiovascular Therapeutics (TCT) conference, at the Miami Beach Convention Center by Michael P. Savage, MD, Director of the Cardiac Catheterization Lab at Jefferson.

Angioplasty or stenting on bypass vessels, called saphenous vein grafts, is associated with a high risk of complications due to distal embolization, the dislodging of plaque and clots downstream, impairing blood flow and leaving patients at-risk for a heart attack.

Distal protection devices are commonly used to prevent blockages by catching the dislodged plaque and clot in a basket-like device, allowing blood to filter through the bypassed artery. Still, complications remain in up to 10 percent of patients. Preliminary studies have suggested that prophylactic doses of the drug nicardipine, a common intracoronary vasodilator, can also help in this regard, but never have the two techniques been combined.

Savage and colleagues looked at clinical outcomes at 30 days post-PCI in 163 consecutive patients with prior bypass surgery. Group I consisted of 60 patients who underwent PCI using a distal protection device alone (no pre-treatment with nicardipine); Group II included 103 patients who underwent PCI with a distal protection device and pre-treatment with prophylactic nicardipine.

Both groups had similar baseline demographics including age (early 71 +/- 10 years), diabetes (47 vs. 44 percent) and bypass graft age (13 +/- 6 years). Group II had longer lesion length, requiring a longer stent and placing these patients at higher risk for complications.

At 30-days post-PCI death, heart attack, bypass or repeat PCI occurred in 10 percent of patients in Group I and in only one percent of patients in Group II. Mortality was 3.3 percent in Group I vs. zero in Group II, and incidence of MI was 10 percent in Group I vs. one percent in Group II. There was zero incidence of CABG, repeat PCI or stent thromboses in either group.

“Through the combined power of these two therapies, we have a new approach that is improving outcomes for this high risk subset of patients,” says Savage.

source : http://www.news-medical.net/news/20121023/Combining-distal-protection-devices-with-nicardipine-improves-post-PCI-outcomes.aspx

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Abbott’s Absorb Bioresorbable Vascular Scaffold Launched Internationally

Abbott’s Absorb Bioresorbable Vascular Scaffold Launched Internationally

Abbott’s Absorb Bioresorbable Vascular Scaffold Launched Internationally

Abbott Announces International Launch of the Absorb™ Bioresorbable Vascular Scaffold

World’s First Drug Eluting Bioresorbable Vascular Scaffold has Potential to Revolutionize Treatment of Coronary Artery Disease

Absorb Now Available in More Than 30 Countries Across Europe and Parts of Asia Pacific and Latin America

Clinical Data and Initial Commercial Experience Reinforce Broad Clinical Benefit of Absorb

September 25, 2012

Abbott Park, Illinois (NYSE: ABT) — Abbott announced today that Absorb™, the world’s first drug eluting bioresorbable vascular scaffold (BVS), is now widely available across Europe and parts of Asia Pacific and Latin America. Absorb is a first-of-its-kind device for the treatment of coronary artery disease (CAD). It works by restoring blood flow to the heart similar to a metallic stent, but then dissolves into the body, leaving behind a treated vessel that may resume more natural function and movement because it is free of a permanent metallic stent. Absorb is made of polylactide, a naturally dissolvable material that is commonly used in medical implants such as dissolving sutures.

 

The potential long-term benefits of a scaffold that dissolves are significant. The vessel may expand and contract as needed to increase the flow of blood to the heart in response to normal activities such as exercising; treatment and diagnostic options are broadened; the need for long-term treatment with anti-clotting medications may be reduced; and future interventions would be unobstructed by a permanent implant.

“This innovation represents a true paradigm shift in how we treat coronary artery disease. With the launch of Absorb, a scaffold that disappears after doing its job is no longer a dream, but a reality,” said Patrick W. Serruys, M.D., Ph.D., professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, the Netherlands. “Patients are excited about Absorb since it may allow blood vessels to return to a more natural state and expand long-term diagnostic and treatment options.”

The international launch of Absorb is supported by a robust clinical trial program that encompasses five studies in more than 20 countries around the world. Study data indicate that Absorb performs similar to a best-in-class drug eluting stent across traditional measures such as major adverse cardiovascular events (MACE) and target lesion revascularization (TLR), while providing patients with the added benefits associated with a device that dissolves over time. As the Absorb scaffold dissolves, vascular function is potentially restored to the blood vessel, allowing more blood to flow through the vessel as the body requires.

“Absorb is a leading example of Abbott’s dedication to advancing patient outcomes through innovative technology. Abbott has remained committed to meeting the growing physician and patient demand for a bioresorbable vascular scaffold – from the initial device developed nearly 10 years ago to the expansion of our manufacturing capabilities to support this international launch,” said John M. Capek, executive vice president, Medical Devices, Abbott. “We are proud to be the first company to commercialize a drug eluting bioresorbable vascular scaffold, which has the potential to revolutionize the way physicians treat their patients with coronary artery disease.”

Heart disease is the leading cause of death for men and women around the world, and CAD is the most common type of heart disease.1,2 CAD occurs when arteries that supply blood to the heart become narrowed or blocked, leading to chest pain or shortness of breath and increased risk of heart attack.

About the Absorb Bioresorbable Vascular Scaffold

Absorb is now available in a broad size matrix to support the needs of physicians treating patients with CAD.

The Absorb bioresorbable vascular scaffold, similar to a small mesh tube, is designed to open a blocked heart vessel and restore blood flow to the heart. Absorb is referred to as a scaffold to indicate that it is a temporary structure, unlike a stent, which is a permanent implant. The scaffold provides support to the vessel until the artery can stay open on its own, and then dissolves naturally. Absorb leaves patients with a vessel free of a permanent metallic stent and may allow the vessel to resume more natural function and movement, enabling long-term benefits.3,4

Abbott’s BVS delivers everolimus, an anti-proliferative drug used in Abbott’s XIENCE coronary stent systems. Everolimus was developed by Novartis Pharma AG and is licensed to Abbott by Novartis for use on its drug eluting vascular devices. Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent implantation, due to its anti-proliferative properties.

Absorb is neither approved nor authorized for sale and currently is in development with no regulatory status in the United States. Absorb is authorized for sale in CE Mark countries. Absorb is now available in Europe, the Middle East, parts of Asia Pacific, including Hong Kong, Singapore, Malaysia and New Zealand, and parts of Latin America.

About Abbott Vascular

Abbott Vascular is the world’s leader in drug eluting stents. Abbott Vascular has an industry-leading pipeline and a comprehensive portfolio of market-leading products for cardiac and vascular care, including products for coronary artery disease, vessel closure, endovascular disease and structural heart disease.

About Abbott

Abbott (NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 91,000 people and markets its products in more than 130 countries.

Back in 2006 when we first started to report on Abbott‘s development of bioresorbable stents, we were quite optimistic. Now a representative for the company is telling us that Abbott has finally received European approval for the ABSORB stent, a device that eventually frees the vessel to be in its almost natural, pulsating and re-endothelialized state. This is the world’s first drug-eluting bioresorbable stent and the plan is to slowly roll it out in Europe starting in a limited number of institutions and aiming for a full release toward the end of 2012.

Abbott Gets EU OK for Worlds First Bioresorbable Drug Eluting Stent

ABSORB is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as resorbable sutures. Since a permanent metallic implant is not left behind, a patient’s vessel treated with ABSORB may ultimately have the ability to move, flex and pulsate similar to an untreated vessel. Restoration of these naturally occurring vessel functions, or vascular restoration therapy (VRT), is one of the features that makes ABSORB a significant innovation for patients in the treatment of coronary artery disease. In addition, continuing research indicates that the need to administer long-term dual anti-platelet therapy to patients may be reduced because the temporary scaffold is completely resorbed.

CE Mark approval for ABSORB in Europe was supported by data from the ABSORB clinical trials, which included patient follow-up out to three years. To further study the device in an expanded population, Abbott plans to initiate a randomized, controlled clinical trial in Europe later this year. The study will enroll approximately 500 patients at 40 centers throughout Europe and will compare ABSORB to Abbott’s XIENCE PRIME, which, together with XIENCE V, is the market-leading drug eluting stent system in Europe. The trial will provide additional data to support European commercialization and reimbursement activities. A global trial, including the U.S. and other geographies, is planned for later this year.

Source : http://www.abbott.com/news-media/press-releases/abbott-announces-international-launch-of-the-absorb-bioresorbable-vascular-scaffold.htm

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STENTYS announces European commercial release of new Self-Apposing stent technology

STENTYS announces European commercial release of new Self-Apposing stent technology

STENTYS (FR0010949404 – STNT), a medical technology company commercializing the world’s first and only self-apposing stent to treat Acute Myocardial Infarction (AMI), announced today the European commercial release of an enhanced stent-delivery system for its Self-Apposing® stent.

Stents are implanted in the coronary arteries via a keyhole in the groin or in the wrist under angiography (X-ray imaging). Cardiologists use a delivery catheter to navigate through the arteries, reach the occluded vessel and deploy the stent. The new catheter to implant the STENTYS Self-Apposing stent adds a hydrophilic (slippery) coating and an ergonomic handle that considerably facilitates stent implantation in tortuous vessels.

Gonzague Issenmann, Chief Executive Officer and co-founder of STENTYS, commented: “Feedback from cardiologists suggests the new delivery catheter is very user-friendly and we are confident this product enhancement will allow a greater range of patients to benefit from our STENTYS Self-Apposing stent technology.”

In its latest guidelines on AMI treatment, the European Society of Cardiology (ESC) calls attention to the importance of selecting the appropriate stent size, as the vessel in this setting is contracted and contains thrombus (clot), and to the complications that may result from inappropriate stent sizing. The STENTYS Self-Apposing® Stent solves that “stent-sizing dilemma”: it fits into the contour of a blood vessel, and its shape and diameter adapt as the vessel dilates and the initial clot dissolves during the post-AMI phase.

Source : www.news-medical.net/news/20120927/STENTYS-announces-European-commercial-release-of-new-Self-Apposing-stent-technology.aspx

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STENTYS announces European commercial release of new Self-Apposing stent technology

STENTYS announces European commercial release of new Self-Apposing stent technology

STENTYS (FR0010949404 – STNT), a medical technology company commercializing the world’s first and only self-apposing stent to treat Acute Myocardial Infarction (AMI), announced today the European commercial release of an enhanced stent-delivery system for its Self-Apposing® stent.

Stents are implanted in the coronary arteries via a keyhole in the groin or in the wrist under angiography (X-ray imaging). Cardiologists use a delivery catheter to navigate through the arteries, reach the occluded vessel and deploy the stent. The new catheter to implant the STENTYS Self-Apposing stent adds a hydrophilic (slippery) coating and an ergonomic handle that considerably facilitates stent implantation in tortuous vessels.

Gonzague Issenmann, Chief Executive Officer and co-founder of STENTYS, commented: “Feedback from cardiologists suggests the new delivery catheter is very user-friendly and we are confident this product enhancement will allow a greater range of patients to benefit from our STENTYS Self-Apposing stent technology.”

In its latest guidelines on AMI treatment, the European Society of Cardiology (ESC) calls attention to the importance of selecting the appropriate stent size, as the vessel in this setting is contracted and contains thrombus (clot), and to the complications that may result from inappropriate stent sizing. The STENTYS Self-Apposing® Stent solves that “stent-sizing dilemma”: it fits into the contour of a blood vessel, and its shape and diameter adapt as the vessel dilates and the initial clot dissolves during the post-AMI phase.

Source : http://www.news-medical.net/news/20120927/STENTYS-announces-European-commercial-release-of-new-Self-Apposing-stent-technology.aspx

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