News

Corindus Announces First Robotic-Assisted PCI Procedures in CorPath^® PRECISE Clinical Trial

Study underway to evaluate robotic-assisted placement of coronary guidewires and stent/balloon catheters Corindus Vascular Robotics, a developer of precision vascular robotics, announced that the clinical trial of its CorPath^® PRECISE (Percutaneous Robotic-Enhanced Coronary Intervention Study) has begun. The first percutaneous coronary intervention (PCI) procedures using the CorPath 200 System were performed at NewYork-Presbyterian Hospital/Columbia University Medical Center in New York and St. Elizabeth’s Medical Center in Boston. “For the very first time in my career, I was able to perform a PCI procedure without wearing a lead apron,” said Jeffrey W. Moses, MD, investigator of the CorPath PRECISE trial, director of Interventional Cardiology at New York-Presbyterian Hospital, director of the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center, professor of medicine at Columbia University College of Physicians and Surgeons, and professor of medicine at Weill Cornell Medical College, New York, New York. “The CorPath System’s radiation-shielded cockpit provided an optimal view of the angiography screen, and allowed me to easily manipulate the guidewire and accurately place the stent. I was impressed — this trial has the potential to significantly impact how we care for patients in the cath lab.” The trial is a prospective, single-arm, multi-center study, which will initially enroll 154 patients. Investigators will evaluate the safety and effectiveness of the CorPath 200 System in delivering and manipulating coronary guidewires and stent/balloon systems in PCI procedures. The trial is led by the co-principal investigators Giora Weisz, MD, co-director of clinical services at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center and assistant professor of medicine at Columbia University College of Physicians and Surgeons, New York, New York, and Joseph P. Carrozza, MD, Chief of Cardiovascular Medicine at St. Elizabeth’s Medical Center, Boston, Mass. “I am pleased to lead and take part in a trial that is addressing a long-time need in the cath lab — improved safety and ergonomics,” said Dr. Carrozza. “The comfortable, seated position allowed me to focus solely on the patient’s physiology, while I was able to precisely control the guidewire and stent movements, even in 1-mm increments. Our first case was successful, and I look forward to performing more procedures using CorPath.” The CorPath PRECISE trial will be conducted at leading medical centers across the United States, including New York-Presbyterian/Columbia, St. Elizabeth’s Medical Center, Virginia Commonwealth University Medical Center in Richmond, Va., St. Joseph’s Hospital Health Center in Syracuse, New York, and Swedish Medical Center in Seattle. The results of this study will be the basis for a pre-market clearance [510(k)] application to the FDA. Note: The CorPath 200 System is an investigational device and limited by federal law to investigational use only. ————————————————————

First Dedicated Cardiovascular Center at UC San Diego Ready for Patients

On Sunday, April 3, 2011, the gleaming glass doors of the UC San Diego Sulpizio Cardiovascular Center (SCVC), San Diego, California, will welcome patients from across the county and around the world. Six years after receiving a naming gift from the Sulpizio family, the center will open as the region’s first comprehensive, state-of-the art cardiovascular patient care and research facility. UC San Diego Health System leadership, donors, friends, and community leaders joined in a ceremonial ribbon cutting on March 4, 2011. “We’ve aspired to this kind of center for 40 years,” said SCVC director, Kirk Peterson, MD, FACP, FACC, who is also professor of clinical cardiology and a cardiology consultant for the Naval Regional Medical Center and the VA San Diego Healthcare System. “The SCVC represents the culmination of that effort — to have a facility in which all disciplines render cardiac care — housed where we can all work in close proximity.” “This type of collaboration is unique and does not exist anywhere else in San Diego,” said Michael Madani, MD, associate professor of surgery and co-director of the SCVC. “Already, there has been a lot of positive energy generated by combining our efforts and working as a team under the same leadership.” The four-story, 128,000-square-foot building has four operating rooms, four catheterization labs, 22 day beds, 27 acute care beds and an expanded emergency department, shared with Thornton Hospital. “The SCVC is a community resource,” said Ehtisham Mahmud, MD, FACC, professor of medicine and cardiology, director of interventional cardiology and cardiovascular catheterization labs and co-director of the SCVC. “Cardiovascular medicine and surgical specialists will work together to determine optimal treatment strategies and, as the only comprehensive academic medical center in the region, we also train and educate the next generation of specialists in these fields.” ————————————————————

Heart Damage Improves, Reverses After Stem Cell Injections in a Preliminary Human Trial

Researchers have shown for the first time that stem cells injected into enlarged hearts reduced heart size, reduced scar tissue and improved function to injured heart areas, according to a small trial published in Circulation Research: Journal of the American Heart Association. Researchers said that while this research is in the early stages, the findings are promising for the more than five million Americans who have enlarged hearts due to damage sustained from heart attacks. These patients can suffer premature death, have major disability, and experience frequent hospitalizations. Options for treatment are limited to lifelong medications and major medical interventions, such as heart transplantation, according to Joshua M. Hare, MD, the study’s senior author and professor of medicine and director of the Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, University of Miami in Miami, Fla. Using catheters, researchers injected stem cells derived from the patient’s own bone marrow into the hearts of eight men (average age 57) with chronically enlarged, low-functioning hearts. “The injections first improved function in the damaged area of the heart and then led to a reduction in the size of the heart. This was associated with a reduction in scar size. The effects lasted for a year after the injections, which was the full duration of the study,” Hare said. Specifically, researchers found:

• Heart size decreased an average of 15 percent to 20 percent, which is about three times what is possible with current medical therapies.
• Scar tissue decreased by an average of 18.3 percent.
• There was dramatic improvement in the function, or contraction, of specific heart areas that were damaged.

“This therapy improved even old cardiac injuries,” Hare said. “Some of the patients had damage to their hearts from heart attacks as long as 11 years before treatment.” The researchers had used two different types of bone marrow stem cells in their study — mononuclear or mesenchymal stem cells. The study lacked the power to determine if one type of cell works better than the other. All patients in the study benefited from the therapy and tolerated the injections with no serious adverse events. Hare’s study assessed the effect of stem cell injections differently from other studies of post-heart attack stem cell treatment. His team measured contractility, scar size and structural changes of the heart. “Studies of bone marrow cell therapy for ischemic heart disease in animals have shown improved ejection fraction. However, this measurement has not reliably translated to early phase studies in humans,” Hare said. “Ejection fraction may not be the best way to measure the success of stem cell therapy in the human heart.” Hare also said their findings suggest that patients’ quality of life could improve as the result of this therapy because the heart is a more normal size and is better functioning. “But, we have yet to prove this clinical benefit — this is an experimental therapy in phase one studies. These findings support further clinical trials and give us hope that we can help people with enlarged hearts.” ————————————————————

You’ve Gotta Have Heart: Positive Outlook Increases Heart Patients’ Survival

Cardiac patients with optimistic expectations about their recovery were 30 percent less likely to die over the next 15 years than patients with less optimistic expectations, regardless of the severity of their heart disease, according to researchers at Duke University Medical Center. “This study is unique because it shows that a patient’s attitude toward their disease not only impacts their ability to return to a normal lifestyle but also their health over the long term and ultimately their survival,” said John C. Barefoot, PhD, the study’s lead author. The new findings are published in the Archives of Internal Medicine. Researchers followed heart patients after they had diagnostic coronary angiography. While past studies have evaluated how patients’ expectations affect their ability to do daily activities, such as work and exercise, Barefoot says the new findings take that research one step further by demonstrating that one’s outlook has an effect on physical health and survival. More than 2,800 patients with coronary disease were given a psychological questionnaire and asked to evaluate their expectations about their ability to recover from the illness and return to a regular routine. After 15 years, 1,637 patients had died and 54 percent (885 deaths) were due to cardiovascular disease. Barefoot says that the higher risk of death remained even after controlling for a range of factors, including the severity of the coronary disease, age, gender, income, depression, social support, and overall functional ability when they were hospitalized. “We know there is a relationship between depression and increased rates of mortality,” Barefoot says. “These findings demonstrate the magnitude of the impact of patient expectations on the recovery process above and beyond depression and other psychological or social factors.” Barefoot says that optimists may more effectively use coping strategies, such as diligently following their treatment plan, which may positively impact their recovery. Another theory is that negative thoughts can lead to tension and stress, which can have damaging effects on the body. “The take-home message is that having positive expectations can not only make you feel better, but also potentially live longer,” Barefoot says. This research was supported by grants from the National Heart, Lung, and Blood Institute. ————————————————————

‘Good Cholesterol’ Structure Identified, Could Help Explain Protective Effects

University of Cincinnati (UC) researchers have determined the structure of human HDL cholesterol and say the finding could help explain how this “fat packet” protects against cardiovascular diseases, including heart attack and stroke. The study, led by W. Sean Davidson, PhD, professor in UC’s pathology and laboratory medicine department, was published March 13, 2011, in the journal Nature Structural & Molecular Biology. HDL (high-density lipoproteins) also known as “good cholesterol,” are packets of protein and fat that deliver fat to specific locations within the body. There is an increasing effort to create drugs that help to raise levels of HDL working in conjunction with existing drugs that lower “bad cholesterol,” or low-density lipoproteins (LDL). Studies of synthetically derived HDL have shown that an abundant protein in HDL, apolipoprotein A-I, plays a key role in HDL’s cardioprotective anti-inflammatory and anti-oxidative properties. “Unfortunately, we’ve known very little about the molecular details that explain HDL’s protective effects,” says Davidson. “A major reason for this is an almost complete lack of understanding of HDL’s structure and how it interacts with other important plasma factors.” Rong Huang, PhD, a post-doctoral fellow in Davidson’s laboratory, has isolated human HDL and analyzed its 3-D structure as it circulates in human plasma. “Previous studies have only focused on synthetic HDL made in the test tube,” Davidson says. “By isolating human HDL, we were able to focus on the broad range of HDL particles actually circulating in humans.” Team members used a series of sophisticated spectroscopic and mass spectrometric techniques to study HDL and have found that proteins of HDL form a cage-like structure that encapsulates its fatty cargo. They determined that most of the HDL particles circulating in human plasma are remarkably similar in structure; however, they found evidence that the particles have a twisting or shock absorber-like motion that allows them to adapt to changes in particle fat content. By determining the structure of HDL, Davidson and his team were able to conclude that the majority of physiological interactions occurring with HDL, including its twisting movements, occur at the particle surface, which is dominated by the cardioprotective protein apolipoprotein A-I. This monopolization of the particle surface, Davidson says, suggests that other proteins have very little room to bind to HDL and probably have to interact with the protein itself, which could explain how apolipoprotein A-I plays such a dominant role in HDL function and its protective effects. “This work presents the first detailed models of human plasma HDL and has important implications for understanding key interactions in plasma that modulate its protective functions in the context of cardiovascular disease,” says Davidson. The study was funded by grants from the National Institutes of Health and its National Heart, Lung, and Blood Institute, as well as funds from the American Heart Association. ————————————————————

Insufficient Women Enrolled In Clinical Trials For Heart Devices

Despite a long-standing requirement for medical device makers to include women in studies they submit to the Food and Drug Administration for device approval, only a few include enough women or analyze how the devices work specifically in women, according to research reported in Circulation: Cardiovascular Quality and Outcomes. “Women and men differ in their size, bleeding tendencies, and other factors that are directly relevant to how the devices will work,” said Rita F. Redberg, MD, MSc, senior author of the study and professor of medicine and director of Women’s Cardiovascular Services at the University of California, San Francisco. “It is likely that the benefits and risks of devices are different in women. Despite the directive to find out, it isn’t happening.” In 1994, the Center for Devices and Radiological Health instituted a policy that all FDA submissions seeking new device approval must contain:

• A gender-bias statement explaining whether the proportion of men and women in the study reflects the proportion of men and women who have the condition being treated.
• Differences in the safety and effectiveness of the device in women.

In their analysis, researchers reviewed 123 studies contained in the pre-market approval applications for 78 high-risk cardiovascular devices (the category that includes heart valves and implanted defibrillators) that gained FDA approval between 2000 and 2007. In 28 percent of the studies, FDA summaries of the evidence didn’t report the gender of study participants. In those that did, men made up an average of 67 percent. The investigators found that the required gender-bias statement was present in only 41 percent of the studies. Of studies that included the statement, 94 percent discussed examining their results by sex, and 26 percent reported differences in device safety or effectiveness between men and women. In the studies that omitted the gender-bias statement, only 11 percent presented any gender-specific results or discussion. Studies involving fewer than 50 patients were not included in the analysis of sex-specific reporting. Because non-approved pre-market applications are not publicly available, the researchers could not determine whether these contained a similar percentage of gender-bias statements. In approved applications, the reviewers found instances in which researchers used inaccurate grounds to exclude women. In some cases, the proportion of women with a heart condition was understated. In others, applicants declared their gender breakdown to be equivalent to previous studies without acknowledging that the previous studies included a disproportionately low number of women. Between 2000 and 2007, the proportion of women enrolled in studies or the number of successful applications that included the gender-bias statement didn’t increase. “We found no encouraging trends,” Redberg said. “Failure to include women in clinical trials has been a big problem for a long time and it isn’t improving, so further action is needed.” She suggests strict enforcement of the current requirements, including sending applications back without review until the required statements are submitted. Women should ask directly about the data if a device is recommended to them, Redberg said. “Ask how many women it was tested in and how the results looked in those women. Unfortunately, all too often we approve devices based on results in men and assume they will be the same in women. That is not a reasonable assumption, even if a device is being marketed specifically to women.” Note: Redberg is a member of the FDA Circulatory System Devices Panel, but her comments are independent and don’t necessarily reflect the views of the panel or the FDA. ————————————————————

MEDRAD Interventional Introduces Next-Generation Aspiration Catheter, the Fetch^®2 Catheter

Performance improvements in the new device include a flexible, variable pitch coiled shaft for improved kink resistance. Other performance enhancements include an enhanced distal radiopaque marker band for improved visibility and positioning marker bands to minimize the need for fluoroscopy. For operator convenience, Fetch2 also provides dual syringes and filter baskets with a more accessible, clear tray package. The defining features of the earlier Fetch aspiration catheter have been retained, such as low 4.2 Fr catheter profile and convex-cut distal opening. Despite its low profile, the Fetch2 catheter has demonstrated effective clot-removing ability. ————————————————————

ACC/AHA Release Focused Update to the Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction

The American College of Cardiology (ACC) and the American Heart Association (AHA) have released a focused update to the 2007 guidelines for the management of patients with unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI). This focused update allows clinical practice guidelines to keep pace with and respond promptly to the steady stream of new data on which previous diagnosis and care recommendations are based. “By taking another look at the guidelines, and creating a focused update, cardiologists are better able to target advanced therapies and interventional strategies to those at greatest risk,” said R. Scott Wright, MD, professor of medicine and consultant in Cardiology and Acute Coronary Care at the Mayo Clinic, and lead author of the focused update. “We are in an era of incremental improvement in the treatment of patients with acute coronary syndromes. In the absence of a paradigm shift, the future will see incremental benefit as we learn to fine-tune the applications of therapies and revascularization. The challenge is to keep up with the fields of new data.” According to the writing committee, there have been major advances in the management of UA/NSTEMI patients over the past three years that center on four important areas:

1. The timing of acute interventional therapy in patients with non-ST-elevation myocardial infarction has been better clarified by a number of studies. Immediate catheterization and intervention does not offer a benefit over initial medical stabilization followed by early catheterization and intervention in all but the highest risk populations.
2. The timing, duration and application of dual antiplatelet therapy and triple antiplatelet therapy have been clarified with further evidence supporting the role of triple antiplatelet therapy in high-risk patients and dual antiplatelet therapy in all other patients. Additionally, there are at least two thienopyridines that can be used as one of the two agents in dual antiplatelet therapy.
3. The role and potential benefit of invasive therapies in patients with advanced renal dysfunction has been further clarified by data.
4. Participation in a quality of care data registry designed to track and measure outcomes, complications, and adherence to evidence-based processes of care and quality improvement for UA/NSTEMI can drive quality improvement for acute coronary syndromes (ACS).

The 2007 guidelines put into practice an initial non-invasive set of preliminary tests; recommended the use of antiplatelet therapy clopidogrel for at least one year after receiving a drug-eluting stent; highlighted the importance of blood pressure control; and advised cessation of non-steroidal anti-inflammatory drugs (NSAIDS) use for all UA/NSTEMI patients during hospitalization. The 2011 focused update incorporates late-breaking clinical trial results presented in 2008 and 2009, as well as selected data presented through April 2010 that may impact guideline recommendations. These include clarification of the timing and role of invasive therapy with ACS; which patient subgroups should have dual antiplatelet therapy versus triple antiplatelet therapy; and the role of invasive therapy in patients with chronic kidney disease. The 2011 focused update also further incorporates the risk-score risk analysis into clinical decision-making; platelet function and platelet genotype testing; the duration of thienopyridine therapy in patients treated with drug-eluting stents; and the clarification of renal function prior to use of contrast agents with diagnostic angiography. Lastly, the focused update promotes the use of quality of care registries and data repositories to promote quality and increased use of evidence-based medicine. “While the analysis of standard practices is ongoing, this focused approach allows for continual review of new evidence and efficient implementation of important science and treatment trends that could have a major impact on patient outcomes and quality of care,” Wright said. “The clarification of timing and role of invasive therapy, as well as the ability or lack thereof for invasive therapy to offer a benefit in patients with advanced renal dysfunction, is a perfect example of the importance of continuous treatment guidelines review.” The 2011 focused update will be published in the Journal of the American College of Cardiology and Circulation: Journal of the American Heart Association, and will be posted ahead of print on the ACC (www.cardiosource.org) and AHA (www.americanheart.org) websites.