Industry Insider
Clinical and Industry News - Lifestyle, Weight Loss and Diabetes
February 2006
Lifestyle Changes Can Quickly Reverse Heart Risks
In less than a month, individuals can reverse serious heart disease risk factors by making significant lifestyle changes, researchers are reporting.
In an encouraging study conducted on overweight men, researchers found that after three weeks on a high-fiber, low-fat diet and adding up to 60 minutes of daily walking, about half of the study participants reversed or a constellation of unhealthy risk factors called the "metabolic syndrome."
"Our study found that when an individual partakes in a fairly intensive diet and exercise lifestyle modification, that significant changes in their health can be noted in a short period of time," said one of the study’s authors, Christian Roberts, an assistant researcher in the physiological sciences department at the University of California, Los Angeles.
"Most of the population is under the belief that it takes a long time to see improvement. But, we found that we could reverse diabetes and metabolic syndrome within three weeks, despite the fact that these men were still obese," he said. Results of the study appear in the Jan. 10 online issue of the Journal of Applied Physiology.
"I'm glad that more and more people are getting the message out that you can make a difference with lifestyle changes. Even just 10 pounds of weight loss makes a huge difference in blood sugar, blood pressure and your overall well being," said Dr. Katherine Nori, an internist with Beaumont Hospital's Weight Control Center in Royal Oak, Mich.
Thirty-one men between the ages of 46 and 76 participated in the new study. All of the men were either overweight or obese. All of the volunteers had at least one risk factor for metabolic syndrome, and 15 were diagnosed with metabolic syndrome. Thirteen of the men had type 2 diabetes. Several had neither condition.
For three weeks, the men took part in a residential diet and exercise program. Their diets and Weight loss plans were designed at the Pritikin Longevity Center and included 65 to 70 percent complex carbohydrates (fruits, vegetables and whole grains), 15 to 20 percent protein (soy, beans, nuts and occasionally fish and poultry), and 12 to 15 percent fat (less than half from saturated fat).
The study participants were allowed to eat as much as they wanted of fruits, vegetables and whole grains, so Roberts said they weren't left feeling hungry.
Additionally, the men began exercising 45 to 60 minutes daily on a treadmill and did both level and graded walking. Roberts said the men walked at a moderate pace, which meant they could talk while exercising, but if they increased the intensity of their workout a little bit, talking became difficult.
The men lost about two to three pounds each week of the study, but they still remained overweight or obese at the end of the three-week period.
The researchers measured blood levels of cholesterol, insulin and markers of inflammation both before and after the study. At the start of the study, 48 percent of the men had metabolic syndrome, while at the end just 19 percent still did. Forty-two percent had diabetes at the start of the study, but only 23 percent did at the end. The average LDL, or "bad," cholesterol reading went down 25 percent.
"If you have diabetes or metabolic syndrome, you need to know that they are reversible, and you can improve your heart disease risk profile without normalizing your body weight," Roberts said.
Both Roberts and Nori said it was the combination of diet and exercise that affected these dramatic changes, and that neither measure alone is as powerful as the two together. And, both said you have to maintain the changes in order to sustain the health benefits.
"People have the power within themselves to make a difference. Weight loss and exercise consistently improve heart disease risk, and this is something you have control over. You have the ability to dramatically improve whatever level you're at," said Nori. Witt Biomedical Achieves Best in KLAS for Cardiology PACS and Cardiology Reporting & Documenting KLAS, an independent research firm specializing in monitoring and reporting performance of healthcare information technology vendors, announced that Witt Biomedical has achieved Best in KLAS for two KLAS market segments, Cardiology PACS and Cardiology Reporting & Documenting, for 2005. In addition, the 2005 Top 20 Year-End Best in KLAS report named Witt Biomedical the Specialty Niche Category Leader for Cardiology Hemodynamics. This news follows the recent announcement that Witt achieved Number One status in the October 2005 KLAS Cardiology IT Report: Hemodynamics & Clinical Reporting.
Witt’s KLAS ratings are published in the 2005 Top 20 Year-End Best in KLAS report. This report is a summary of the performance data collected over the past 13 months from healthcare professionals and IT Executives. Included in the report is a ranking of the Top 20 vendors overall, as well as a ranking of the top vendors in key areas of performance. Vendors and products are broken down into 26 key market segments. According to KLAS, Specialty Niche categories must have at least two products that meet the KLAS minimum for statistical confidence in order for a product to earn category leader status. To learn more about the 2005 Top 20 Year-End Best in KLAS report, visit www.healthcomputing.com. Aspirin Reduces the Risk of Cardiovascular Events in Men and Women, Though Effects Differ Between Sexes An analysis of previous studies indicates that use of aspirin significantly reduces the risk of cardiovascular events in women and in men, due to reducing the risk of stroke in women and reducing the risk of heart attack in men, according to a study in the January 18 issue of the Journal of the American Medical Association.
Although the benefits of aspirin therapy for reducing the risk of myocardial infarction, stroke, and vascular death among men and women with preexisting cardiovascular disease are well-established, the role of aspirin in primary prevention is less clear. It has not been clear if there is a differential beneficial effect between men and women.
Jeffrey S. Berger, MD, MS, of Duke University, Durham, NC, and colleagues performed a sex-specific meta-analysis of aspirin therapy for the primary prevention of cardiovascular events to better understand the association of sex with the response to aspirin. The researchers performed a search of databases to identify randomized controlled trials of aspirin therapy in participants without cardiovascular disease that reported data on heart attack, stroke, and cardiovascular death. Six trials with a total of 95,456 individuals were identified; three trials included only men, one included only women, and two included both sexes. The authors examined a combined endpoint of any major cardiovascular event (cardiovascular death, nonfatal heart attack, or nonfatal stroke), and each of these individual components separately.
The researchers found that among the 51,342 women, there were 625 strokes, 469 heart attacks, and 364 cardiovascular deaths. Aspirin therapy was associated with a significant 12 percent reduction in cardiovascular events and a 17 percent reduction in stroke, which was a reflection of a 24 percent reduced rate of ischemic stroke. There was no significant effect on heart attacks or cardiovascular death.
Among the 44,114 men, there were 597 strokes, 1,023 heart attacks, and 776 cardiovascular deaths. Aspirin therapy was associated with a significant 14 percent reduction in cardiovascular events and a 32 percent reduction in heart attacks. There was no significant effect on stroke or cardiovascular death. Aspirin treatment resulted in an approximately 70 percent increase in the risk of major bleeding events among women and men.
The authors add that aspirin therapy for an average of 6.4 years results in an average absolute benefit of approximately 3 cardiovascular events prevented per 1,000 women and 4 cardiovascular events prevented per 1,000 men.
¦the favorable effect of aspirin on the combined risk of cardiovascular events for women and men is apparent from these randomized studies. Aspirin use is also associated with a significant risk of major bleeding irrespective of sex. Both the beneficial and harmful effects of aspirin should be considered by the physician and patient before initiating aspirin for the primary prevention of cardiovascular disease in both sexes, the authors conclude. Source: JAMA 2006;295:306-313. Terumo Interventional Systems to Part Ways with Boston Scientific Corporation in Vascular Interventional Products Business With the vascular interventions market surging 12 percent annually, Terumo Medical Corp. a division of Terumo Corp. announced that it will launch a new direct sales, marketing, and distribution strategy in the United States and Latin America.
The new strategy will strengthen relationships between Terumo and thousands of specialists across the United States and throughout Latin America, including interventional radiologists, interventional cardiologists, interventional neuroradiologists and vascular surgeons. The announcement comes in support of Terumo Corp.’s global strategy to expand its presence in all markets with particular focus on the United States, a market that accounts for approximately 50 percent of all interventional products sold worldwide.
The new strategy replaces the 15-year relationship between Terumo and Boston Scientific through which Boston Scientific provided marketing, sales and distribution of Terumo’s vascular interventional products.
The new strategy, which goes into effect April 1, 2006, enables Terumo Interventional Systems and Terumo Latin American Corp. to take over the marketing, sales, distribution and service of its full line of interventional vascular products, including Glidewire® hydrophilic coated guidewires considered the gold standard in wires used to access and cross difficult to treat lesions; Glidecath® hydrophilic coated catheters; and Pinnacle introducer sheaths. Terumo currently employs this strategy for its full line of peripheral embolization products, including Bead Block microspheres and Progreat microcatheters. OmniSonics’ Resolution® Endovascular System Receives 510(k) Clearance from FDA The U.S. Food and Drug Administration (FDA) has given 510(k) clearance for the Resolution® Endovascular System for treatment of thrombosed synthetic hemodialysis access grafts. There are approximately 300,000 patients on hemodialysis in the U.S., according to the U.S. Renal Data System (USRDS), and the number is growing at around 5% per year. Every year a large number of these patients suffer occlusions of their grafts. Greater than 90,000 graft thrombectomies are performed on these patients annually to allow patients to continue hemodialysis treatment.
Early physician response has been encouraging. Dr. John Martin (Anne Arundel Medical Center, Annapolis, MD) was among the first to use the device and commented, The Resolution Endovascular System rapidly clears the graft and reestablishes flow within minutes. I believe this ultrasonic technology may be ideal for peripheral applications, such as deep vein thrombosis.
The Resolution Endovascular System uses OmniWave Technology to deliver low-power acoustic energy 360 degrees around the active length of the Resolution Therapeutic Wire to rapidly resolve blood clots. Acoustic energy is unique in that it dissolves the thrombus, but does not damage the surrounding structures. OmniSonics believes that the OmniWave technology is a platform with many additional future applications to treat unmet clinical needs in vascular occlusive disease. OmniSonics is currently developing OmniWave Technology to apply it to deep vein thrombosis, peripheral arterial limb ischemia and catheter clearance, as well as investigating neurovascular and coronary applications.
The Resolution Endovascular System consists of two primary components, the Generator and the Resolution System Kit. The Resolution System Kit consists of a handpiece with attached wire and accessory irrigation tubing. The Generator controls an electrical signal to power the handpiece. The handpiece converts the electronic signal from the generator to low-power ultrasonic energy transmitted down the length of the Resolution Therapeutic Wire. The Resolution Therapeutic Wire distributes ultrasonic energy waves that generate a cavitational streaming effect that breaks the fibrin bonds.
Treatment with the Resolution Endovascular System utilizes typical interventional technique and is compatible with common interventional devices (5Fr and .035 wire compatibility). Medication Plus Beta-Blocker Helps Prevent Shocks from Implantable Cardioverter Defibrillator Use of the medication amiodarone in combination with a beta-blocker is effective in preventing shocks that can occur from an implantable cardioverter defibrillator, according to a study in the January 11 issue of the Journal of the American Medical Association.
Antiarrhythmic drugs such as amiodarone and sotalol have the potential for reducing both appropriate and inappropriate shocks, but their relative efficacy to prevent shocks compared with standard therapy with a beta-blocker is unknown. Amiodarone has multiple effects on the heart; however, despite decades of use, it has never been compared with beta-blockers in a randomized controlled study. Sotalol is a beta-blocker with properties that are thought to help prevent ICD shocks, although previous studies have shown mixed results with this medication.
Stuart J. Connolly, MD, of McMaster University, Hamilton, Ontario, Canada, and colleagues compared amiodarone plus a beta-blocker, sotalol alone, or standard beta-blocker therapy alone for prevention of ICD shocks in the OPTIC study. The randomized controlled trial included 412 patients from 39 outpatient ICD clinical centers located in Canada, Germany, United States, England, Sweden, and Austria, and was conducted from January 13, 2001, to September 28, 2004. Patients were eligible if they had received an ICD within 21 days for inducible or spontaneously-occurring ventricular tachycardia (VT) or ventricular fibrillation (VF). Patients were randomized to treatment for 1 year of amiodarone plus beta-blocker, sotalol alone, or beta-blocker alone.
A significant reduction (56 percent) was observed in the risk of a shock when the 274 patients randomized to either of the two active treatment groups, sotalol or amiodarone plus beta-blocker, were compared with the 138 patients randomized to beta-blocker alone. Amiodarone plus beta-blocker significantly reduced (73 percent) the risk of shock compared with beta-blocker alone and sotalol (57 percent reduction). There was a non-significant trend for sotalol to reduce the risk of shock compared with beta-blocker alone.
In patients randomized to beta-blocker alone, the annual risk of any shock was 38.5 percent. The annual risk of an appropriate shock (for VT or VF) was 22.0 percent and the annual risk of an inappropriate shock (mostly for supraventricular arrhythmia) was 15.4 percent. Both types of shock were significantly reduced by amiodarone plus beta-blocker but not significantly reduced by sotalol. Adverse pulmonary and thyroid events, and symptomatic bradycardia were more common among patients receiving amiodarone.
Should amiodarone or sotalol be administered immediately after ICD implantation or some time before a first shock occurs? By delaying therapy, one reduces the risk of drug-related adverse effects; however, this needs to be balanced against the adverse experience of receiving shock therapy. Fourteen patients (10 percent) receiving beta-blocker alone experienced their first shock as multiple (2 shocks or more within 24 hours). On the other hand, a majority of patients did not have a shock in the year of follow-up in this OPTIC trial. Therapeutic decisions should be individualized, taking into account possible improvements in quality of life and small but increased risks of drug-related adverse effects, the authors conclude. Source: JAMA 2006;295:165-171. Abbott Receives FDA Approval for StarClose Vascular Closure System Abbott announced it received Food and Drug Administration (FDA) approval to market its StarClose Vascular Closure System, a new vessel closure device.
StarClose introduces a tiny circumferential flexible clip onto the surface of the femoral artery, closing the artery securely in a matter of seconds following diagnostic catheterization procedures. The StarClose clip is designed for delivery through the sheath, a feature intended to avoid contact with the skin and thus decrease the risk of infection. Physicians can deliver the clip to the surface of a femoral artery with a series of four clicks of the device. The clip is made of nitinol, a nickel-titanium composite that remembers its shape once released from the StarClose device.
Abbott completed the CLIP (Clip CLosure In Percutaneous Procedures) Study to gain approval for StarClose. The CLIP Study compared the safety and efficacy of StarClose versus manual compression in 208 patients who underwent diagnostic catheterization procedures. The StarClose device showed a significant advantage over manual compression in time to hemostasis (cessation of bleeding) and time to ambulation (walking around). Median time to hemostasis was 16.8 seconds for the 136 StarClose patients versus 15.0 minutes for the 72 patients who underwent manual compression. No infections or major vascular complications were observed in either group. Major vascular complications were defined as vascular injury requiring repair, new ipsilateral lower extremity ischemia, transfusion, infection and nerve injury.
Preliminary data from the study indicated that patients whose vessels were closed with StarClose were able to get up and walk approximately two hours earlier and leave the hospital approximately two hours sooner than those who underwent vessel closure with standard manual compression.
Abbott launched StarClose in Europe in 2004, where it has been used successfully in over 55,000 procedures to date. Having Sibling With Cardiovascular Disease Associated With Higher CVD Risk, Compared to Other Common Risk Factors Middle-aged adults who have a sibling with cardiovascular disease (CVD) have a 45 percent increased risk for CVD, a risk that is greater than that conferred by having parents with CVD, according to a study in the Journal of the American Medical Association.
Cardiovascular disease in a first-degree relative confers increased risk for CVD, but whether familial CVD is truly an independent risk factor remains controversial. Risk associated with CVD in siblings is uncertain because published estimates are largely derived from case-control studies that generally lack sibling CVD event validation. Furthermore, estimates regarding magnitude of risk associated with a history of sibling CVD vary greatly. Accurate information about familial CVD will have increasing importance in prevention and treatment of CVD in the post-genome era.
Joanne M. Murabito, MD, ScM, of the Framingham Heart Study, Framingham, Mass., and colleagues conducted a study to determine whether the occurrence of a validated sibling CVD event predicted CVD events in a cohort of middle-aged adults, and examined the impact of sibling CVD over and above that of parental CVD. The researchers analyzed data from the Framingham Offspring Study, a part of the Framingham Heart Study, a population-based study initiated in 1948 with the offspring cohort initiated in 1971. Participants were members of the offspring cohort aged 30 years or older, free of CVD, and with at least 1 sibling in the study. All were followed up for eight years.
Among 973 person-examinations in those who had a sibling with CVD group (average age, 57 years) and 4,506 person-examinations in those with no sibling with CVD group (average age, 47 years), 329 CVD events occurred during follow-up. The researchers found that sibling CVD was associated with a 55 percent increased risk for incident CVD; this association persisted even after adjustment for risk factors (45 percent increased risk). The attributable risk percentage for sibling CVD was 27.4 percent; this represents the proportion of the eight-year CVD risk among those in the sibling CVD group that theoretically would not have occurred if members of the group had not had a sibling with CVD.
Using validated events and a prospective design, our study substantially extends the knowledge base regarding the importance of sibling CVD. We observed that sibling CVD confers increased risks of CVD events above and beyond traditional risk factors and parental premature CVD. Thus, sibling CVD should be considered as important as parental premature CVD in the assessment of risk. Further investigation is needed to better understand why sibling history may be a stronger predictor for CVD than parental history, including exploration of the contribution of an early shared environment to increased sibling risk. Moreover, investigation of whether to incorporate sibling CVD as well as parental CVD into existing risk prediction and prevention algorithms is warranted, the authors conclude. Source: JAMA 2005; 294:3117-3123. CoreValve Successfully Initiates First North American Clinical Trial CoreValve announced that follow-up testing conducted several days after the first percutaneous ReValving procedure performed in North America to replace a patient’s defective aortic heart valve showed perfect functioning and anchoring of the new biological heart valve.
Because of ReValving, the 64-year-old high-surgical-risk female patient was able to avoid open-heart surgery. The successful procedure was performed by Dr. Raoul Bonan, an interventional cardiologist at the Montreal Heart Institute, Quebec, Canada. He was assisted by Montreal Heart Institute colleagues Dr. Raymond Cartier, cardiac surgeon, and Dr. Andre Denault, cardiac anesthesiologist. In addition, Dr. Bonan also was assisted by Dr. Jean-Claude Laborde, an interventional cardiologist at Clinique Pasteur, Toulouse, France, who has had extensive clinical experience with the CoreValve Percutaneous ReValving System.
CoreValve has developed a system for replacing an aortic heart valve via a percutaneous approach on a beating heart. Excluding prep time, the second-generation CoreValve Percutaneous ReValving System holds, delivers and places a porcine pericardial-tissue bioprosthesis, via a small, 21 French-sized catheter, during a 15-minutes-or-less procedure performed by an interventional cardiologist in a cath lab setting.
It is important to point out that this patient’s pre-op condition was substantially impaired by a very severe idiopathic pulmonary fibrosis and a significant stenotic aortic heart valve, said Dr. Jacques Séguin, founder, chairman and CEO of CoreValve. In fact, she was not considered a candidate for open-heart surgery by the surgeons at the Montreal Heart Institute because of her high-risk status (i.e., severe idiopathic pulmonary fibrosis) and, in short, this patient was out of options had it not been for CoreValve’s non-surgical ReValving approach to treat her defective aortic heart valve.
Dr. Raoul Bonan noted, In this patient’s particular situation, her cardiac function is now greatly improved as evidenced by post-procedure echocardiography. Considering that, pre-ReValving, she was NYHA functional classification IV, this rapid turnaround of cardiovascular function is dramatic. The fact that we could perform this procedure in a cath lab is further evidence that ReValving has tremendous potential to non-surgically treat the large numbers of patients who have diseased aortic heart valves but who are not good candidates for surgery. Patients Who Could Benefit Most are Least Likely to Take Drugs Regularly Nearly half the coronary artery disease (CAD) patients in a seven-year study admitted they don’t consistently take beta blockers, cholesterol-lowering drugs and other medications that could extend their lives, researchers report in Circulation: Journal of the American Heart Association.
Recent focus has been on ensuring that hospitalized patients are prescribed the proper preventive medications at discharge.
However, attention should also be focused on improving long-term and consistent use of those medications, said Kristin Newby, MD, lead author of the study and associate professor of medicine at Duke University Medical Center in Durham, NC.
Researchers examined changes in the prevalence and consistency of use of evidence-based secondary prevention medications. From 1995-2002, they found the use of therapies with proven survival benefit in CAD patients has improved. However, their use remains less than what is optimally needed, Newby said. Consistent adherence to these medications was lower despite the fact that failure to use them was associated with lower survival rates.
Researchers tapped the Duke Databank for Cardiovascular Disease to analyze medication adherence among 31,750 patients who had undergone a cardiac procedure at Duke, had at least one coronary artery more than 50 percent blocked or had heart bypass surgery. All patients reported their use of aspirin, beta blockers and lipid-lowering drugs in annual surveys.
Patients had to have at least two consecutive surveys returned during the study. Consistent use was defined as reporting use of medications on at least two consecutive occasions and continuing to report use through the end of the study period. Angiotensin-converting enzyme (ACE) inhibitors were reported for patients with and without heart failure. Researchers found the use of all drugs and combinations increased each year. By 2002:
83 percent of patients reported using aspirin; 61 percent reported using a beta blocker; 63 percent reported taking a lipid-lowering drug; 54 percent used aspirin plus beta blocker; and 39 percent reported using all three drugs. However, consistent use during the study period was lower. Researchers found: 71 percent of patients said they used aspirin consistently; 46 percent adhered to beta blockers; 44 percent stuck with a lipid-lowering drug; 36 percent committed to aspirin plus beta blocker; and only 21 percent used all three consistently.
Among patients who had not experienced heart failure, 39 percent reported using ACE inhibitors in 2002; however, consistent use was at 20 percent. Among patients who had experienced heart failure, ACE inhibitor use was 51 percent in 2002 and consistent use was 39 percent.
Consistent use of any of the therapies was associated with higher survival rates. An association was not found, however, among patients who used ACE inhibitors but had not experienced heart failure. Older patients, those with heart failure, smokers and diabetics were least likely to consistently take medication.
These are the groups with the highest risk of poor outcome, and therefore the groups that could potentially benefit the most from sustained therapy, Newby said. As a remedy, she suggested educational and adherence intervention programs implemented via pharmacists and medical care providers.
Researchers acknowledge that because the patients were mostly from North Carolina and southern Virginia, the results may not be representative of the entire U.S. population.
Patients with CAD, their families and their care providers should be familiar with the therapies that improve clinical outcomes and understand the importance of taking them regularly, Newby said. Each of these individuals plays a critical role in ensuring not only that the drugs are prescribed, but also that they continue to be taken during long-term management of CAD.
Newby said that teams of researchers, clinicians, nurses, pharmacists, policy-makers, patients and their families should continue to work on solutions to guarantee improved and consistent long-term use of evidence-based secondary prevention therapies. Administering Stem Cells to Patients With Myocardial Infarction Leads to a Reduction of the Infarct Researchers at the Catholic University of Leuven (The Netherlands), connected with the University Hospital-Gasthuisberg, the Stem Cell Institute Leuven (SCIL), and the Flanders Interuniversity Institute for Biotechnology (VIB), published a breakthrough in the treatment of patients with acute myocardial infarction. Their research shows that the administration of a patient’s own stem cells has a significant positive effect on the heart’s recovery: in the patients studied, the size of the infarct was clearly reduced. The use of stem cells appears to be safe, and to date, no side effects have occurred that can be attributed to the stem cells. The study is being published in The Lancet.
The researchers in Leuven tested the administration of bone marrow stem cells on patients stricken with acute myocardial infarction. Sixty-seven patients in the study underwent balloon angioplasty, and within 24 hours, some patients received an injection of stem cells from their own bone marrow and some received an aqueous (placebo) solution. The study was double-blind.
Improvement in the global functioning of the left ventricle was comparable in both the control group and the stem cell group. However, a clear global improvement in function was found in the sub-group of patients who had been afflicted with the most serious infarctions. Moreover, the reduction of the size of infarct was significantly greater in all patients in the stem cell group and correlated with a better preserved regional left ventricle function. The researchers note that further studies need to be conducted.
In an encouraging study conducted on overweight men, researchers found that after three weeks on a high-fiber, low-fat diet and adding up to 60 minutes of daily walking, about half of the study participants reversed or a constellation of unhealthy risk factors called the "metabolic syndrome."
"Our study found that when an individual partakes in a fairly intensive diet and exercise lifestyle modification, that significant changes in their health can be noted in a short period of time," said one of the study’s authors, Christian Roberts, an assistant researcher in the physiological sciences department at the University of California, Los Angeles.
"Most of the population is under the belief that it takes a long time to see improvement. But, we found that we could reverse diabetes and metabolic syndrome within three weeks, despite the fact that these men were still obese," he said. Results of the study appear in the Jan. 10 online issue of the Journal of Applied Physiology.
"I'm glad that more and more people are getting the message out that you can make a difference with lifestyle changes. Even just 10 pounds of weight loss makes a huge difference in blood sugar, blood pressure and your overall well being," said Dr. Katherine Nori, an internist with Beaumont Hospital's Weight Control Center in Royal Oak, Mich.
Thirty-one men between the ages of 46 and 76 participated in the new study. All of the men were either overweight or obese. All of the volunteers had at least one risk factor for metabolic syndrome, and 15 were diagnosed with metabolic syndrome. Thirteen of the men had type 2 diabetes. Several had neither condition.
For three weeks, the men took part in a residential diet and exercise program. Their diets and Weight loss plans were designed at the Pritikin Longevity Center and included 65 to 70 percent complex carbohydrates (fruits, vegetables and whole grains), 15 to 20 percent protein (soy, beans, nuts and occasionally fish and poultry), and 12 to 15 percent fat (less than half from saturated fat).
The study participants were allowed to eat as much as they wanted of fruits, vegetables and whole grains, so Roberts said they weren't left feeling hungry.
Additionally, the men began exercising 45 to 60 minutes daily on a treadmill and did both level and graded walking. Roberts said the men walked at a moderate pace, which meant they could talk while exercising, but if they increased the intensity of their workout a little bit, talking became difficult.
The men lost about two to three pounds each week of the study, but they still remained overweight or obese at the end of the three-week period.
The researchers measured blood levels of cholesterol, insulin and markers of inflammation both before and after the study. At the start of the study, 48 percent of the men had metabolic syndrome, while at the end just 19 percent still did. Forty-two percent had diabetes at the start of the study, but only 23 percent did at the end. The average LDL, or "bad," cholesterol reading went down 25 percent.
"If you have diabetes or metabolic syndrome, you need to know that they are reversible, and you can improve your heart disease risk profile without normalizing your body weight," Roberts said.
Both Roberts and Nori said it was the combination of diet and exercise that affected these dramatic changes, and that neither measure alone is as powerful as the two together. And, both said you have to maintain the changes in order to sustain the health benefits.
"People have the power within themselves to make a difference. Weight loss and exercise consistently improve heart disease risk, and this is something you have control over. You have the ability to dramatically improve whatever level you're at," said Nori. Witt Biomedical Achieves Best in KLAS for Cardiology PACS and Cardiology Reporting & Documenting KLAS, an independent research firm specializing in monitoring and reporting performance of healthcare information technology vendors, announced that Witt Biomedical has achieved Best in KLAS for two KLAS market segments, Cardiology PACS and Cardiology Reporting & Documenting, for 2005. In addition, the 2005 Top 20 Year-End Best in KLAS report named Witt Biomedical the Specialty Niche Category Leader for Cardiology Hemodynamics. This news follows the recent announcement that Witt achieved Number One status in the October 2005 KLAS Cardiology IT Report: Hemodynamics & Clinical Reporting.
Witt’s KLAS ratings are published in the 2005 Top 20 Year-End Best in KLAS report. This report is a summary of the performance data collected over the past 13 months from healthcare professionals and IT Executives. Included in the report is a ranking of the Top 20 vendors overall, as well as a ranking of the top vendors in key areas of performance. Vendors and products are broken down into 26 key market segments. According to KLAS, Specialty Niche categories must have at least two products that meet the KLAS minimum for statistical confidence in order for a product to earn category leader status. To learn more about the 2005 Top 20 Year-End Best in KLAS report, visit www.healthcomputing.com. Aspirin Reduces the Risk of Cardiovascular Events in Men and Women, Though Effects Differ Between Sexes An analysis of previous studies indicates that use of aspirin significantly reduces the risk of cardiovascular events in women and in men, due to reducing the risk of stroke in women and reducing the risk of heart attack in men, according to a study in the January 18 issue of the Journal of the American Medical Association.
Although the benefits of aspirin therapy for reducing the risk of myocardial infarction, stroke, and vascular death among men and women with preexisting cardiovascular disease are well-established, the role of aspirin in primary prevention is less clear. It has not been clear if there is a differential beneficial effect between men and women.
Jeffrey S. Berger, MD, MS, of Duke University, Durham, NC, and colleagues performed a sex-specific meta-analysis of aspirin therapy for the primary prevention of cardiovascular events to better understand the association of sex with the response to aspirin. The researchers performed a search of databases to identify randomized controlled trials of aspirin therapy in participants without cardiovascular disease that reported data on heart attack, stroke, and cardiovascular death. Six trials with a total of 95,456 individuals were identified; three trials included only men, one included only women, and two included both sexes. The authors examined a combined endpoint of any major cardiovascular event (cardiovascular death, nonfatal heart attack, or nonfatal stroke), and each of these individual components separately.
The researchers found that among the 51,342 women, there were 625 strokes, 469 heart attacks, and 364 cardiovascular deaths. Aspirin therapy was associated with a significant 12 percent reduction in cardiovascular events and a 17 percent reduction in stroke, which was a reflection of a 24 percent reduced rate of ischemic stroke. There was no significant effect on heart attacks or cardiovascular death.
Among the 44,114 men, there were 597 strokes, 1,023 heart attacks, and 776 cardiovascular deaths. Aspirin therapy was associated with a significant 14 percent reduction in cardiovascular events and a 32 percent reduction in heart attacks. There was no significant effect on stroke or cardiovascular death. Aspirin treatment resulted in an approximately 70 percent increase in the risk of major bleeding events among women and men.
The authors add that aspirin therapy for an average of 6.4 years results in an average absolute benefit of approximately 3 cardiovascular events prevented per 1,000 women and 4 cardiovascular events prevented per 1,000 men.
¦the favorable effect of aspirin on the combined risk of cardiovascular events for women and men is apparent from these randomized studies. Aspirin use is also associated with a significant risk of major bleeding irrespective of sex. Both the beneficial and harmful effects of aspirin should be considered by the physician and patient before initiating aspirin for the primary prevention of cardiovascular disease in both sexes, the authors conclude. Source: JAMA 2006;295:306-313. Terumo Interventional Systems to Part Ways with Boston Scientific Corporation in Vascular Interventional Products Business With the vascular interventions market surging 12 percent annually, Terumo Medical Corp. a division of Terumo Corp. announced that it will launch a new direct sales, marketing, and distribution strategy in the United States and Latin America.
The new strategy will strengthen relationships between Terumo and thousands of specialists across the United States and throughout Latin America, including interventional radiologists, interventional cardiologists, interventional neuroradiologists and vascular surgeons. The announcement comes in support of Terumo Corp.’s global strategy to expand its presence in all markets with particular focus on the United States, a market that accounts for approximately 50 percent of all interventional products sold worldwide.
The new strategy replaces the 15-year relationship between Terumo and Boston Scientific through which Boston Scientific provided marketing, sales and distribution of Terumo’s vascular interventional products.
The new strategy, which goes into effect April 1, 2006, enables Terumo Interventional Systems and Terumo Latin American Corp. to take over the marketing, sales, distribution and service of its full line of interventional vascular products, including Glidewire® hydrophilic coated guidewires considered the gold standard in wires used to access and cross difficult to treat lesions; Glidecath® hydrophilic coated catheters; and Pinnacle introducer sheaths. Terumo currently employs this strategy for its full line of peripheral embolization products, including Bead Block microspheres and Progreat microcatheters. OmniSonics’ Resolution® Endovascular System Receives 510(k) Clearance from FDA The U.S. Food and Drug Administration (FDA) has given 510(k) clearance for the Resolution® Endovascular System for treatment of thrombosed synthetic hemodialysis access grafts. There are approximately 300,000 patients on hemodialysis in the U.S., according to the U.S. Renal Data System (USRDS), and the number is growing at around 5% per year. Every year a large number of these patients suffer occlusions of their grafts. Greater than 90,000 graft thrombectomies are performed on these patients annually to allow patients to continue hemodialysis treatment.
Early physician response has been encouraging. Dr. John Martin (Anne Arundel Medical Center, Annapolis, MD) was among the first to use the device and commented, The Resolution Endovascular System rapidly clears the graft and reestablishes flow within minutes. I believe this ultrasonic technology may be ideal for peripheral applications, such as deep vein thrombosis.
The Resolution Endovascular System uses OmniWave Technology to deliver low-power acoustic energy 360 degrees around the active length of the Resolution Therapeutic Wire to rapidly resolve blood clots. Acoustic energy is unique in that it dissolves the thrombus, but does not damage the surrounding structures. OmniSonics believes that the OmniWave technology is a platform with many additional future applications to treat unmet clinical needs in vascular occlusive disease. OmniSonics is currently developing OmniWave Technology to apply it to deep vein thrombosis, peripheral arterial limb ischemia and catheter clearance, as well as investigating neurovascular and coronary applications.
The Resolution Endovascular System consists of two primary components, the Generator and the Resolution System Kit. The Resolution System Kit consists of a handpiece with attached wire and accessory irrigation tubing. The Generator controls an electrical signal to power the handpiece. The handpiece converts the electronic signal from the generator to low-power ultrasonic energy transmitted down the length of the Resolution Therapeutic Wire. The Resolution Therapeutic Wire distributes ultrasonic energy waves that generate a cavitational streaming effect that breaks the fibrin bonds.
Treatment with the Resolution Endovascular System utilizes typical interventional technique and is compatible with common interventional devices (5Fr and .035 wire compatibility). Medication Plus Beta-Blocker Helps Prevent Shocks from Implantable Cardioverter Defibrillator Use of the medication amiodarone in combination with a beta-blocker is effective in preventing shocks that can occur from an implantable cardioverter defibrillator, according to a study in the January 11 issue of the Journal of the American Medical Association.
Antiarrhythmic drugs such as amiodarone and sotalol have the potential for reducing both appropriate and inappropriate shocks, but their relative efficacy to prevent shocks compared with standard therapy with a beta-blocker is unknown. Amiodarone has multiple effects on the heart; however, despite decades of use, it has never been compared with beta-blockers in a randomized controlled study. Sotalol is a beta-blocker with properties that are thought to help prevent ICD shocks, although previous studies have shown mixed results with this medication.
Stuart J. Connolly, MD, of McMaster University, Hamilton, Ontario, Canada, and colleagues compared amiodarone plus a beta-blocker, sotalol alone, or standard beta-blocker therapy alone for prevention of ICD shocks in the OPTIC study. The randomized controlled trial included 412 patients from 39 outpatient ICD clinical centers located in Canada, Germany, United States, England, Sweden, and Austria, and was conducted from January 13, 2001, to September 28, 2004. Patients were eligible if they had received an ICD within 21 days for inducible or spontaneously-occurring ventricular tachycardia (VT) or ventricular fibrillation (VF). Patients were randomized to treatment for 1 year of amiodarone plus beta-blocker, sotalol alone, or beta-blocker alone.
A significant reduction (56 percent) was observed in the risk of a shock when the 274 patients randomized to either of the two active treatment groups, sotalol or amiodarone plus beta-blocker, were compared with the 138 patients randomized to beta-blocker alone. Amiodarone plus beta-blocker significantly reduced (73 percent) the risk of shock compared with beta-blocker alone and sotalol (57 percent reduction). There was a non-significant trend for sotalol to reduce the risk of shock compared with beta-blocker alone.
In patients randomized to beta-blocker alone, the annual risk of any shock was 38.5 percent. The annual risk of an appropriate shock (for VT or VF) was 22.0 percent and the annual risk of an inappropriate shock (mostly for supraventricular arrhythmia) was 15.4 percent. Both types of shock were significantly reduced by amiodarone plus beta-blocker but not significantly reduced by sotalol. Adverse pulmonary and thyroid events, and symptomatic bradycardia were more common among patients receiving amiodarone.
Should amiodarone or sotalol be administered immediately after ICD implantation or some time before a first shock occurs? By delaying therapy, one reduces the risk of drug-related adverse effects; however, this needs to be balanced against the adverse experience of receiving shock therapy. Fourteen patients (10 percent) receiving beta-blocker alone experienced their first shock as multiple (2 shocks or more within 24 hours). On the other hand, a majority of patients did not have a shock in the year of follow-up in this OPTIC trial. Therapeutic decisions should be individualized, taking into account possible improvements in quality of life and small but increased risks of drug-related adverse effects, the authors conclude. Source: JAMA 2006;295:165-171. Abbott Receives FDA Approval for StarClose Vascular Closure System Abbott announced it received Food and Drug Administration (FDA) approval to market its StarClose Vascular Closure System, a new vessel closure device.
StarClose introduces a tiny circumferential flexible clip onto the surface of the femoral artery, closing the artery securely in a matter of seconds following diagnostic catheterization procedures. The StarClose clip is designed for delivery through the sheath, a feature intended to avoid contact with the skin and thus decrease the risk of infection. Physicians can deliver the clip to the surface of a femoral artery with a series of four clicks of the device. The clip is made of nitinol, a nickel-titanium composite that remembers its shape once released from the StarClose device.
Abbott completed the CLIP (Clip CLosure In Percutaneous Procedures) Study to gain approval for StarClose. The CLIP Study compared the safety and efficacy of StarClose versus manual compression in 208 patients who underwent diagnostic catheterization procedures. The StarClose device showed a significant advantage over manual compression in time to hemostasis (cessation of bleeding) and time to ambulation (walking around). Median time to hemostasis was 16.8 seconds for the 136 StarClose patients versus 15.0 minutes for the 72 patients who underwent manual compression. No infections or major vascular complications were observed in either group. Major vascular complications were defined as vascular injury requiring repair, new ipsilateral lower extremity ischemia, transfusion, infection and nerve injury.
Preliminary data from the study indicated that patients whose vessels were closed with StarClose were able to get up and walk approximately two hours earlier and leave the hospital approximately two hours sooner than those who underwent vessel closure with standard manual compression.
Abbott launched StarClose in Europe in 2004, where it has been used successfully in over 55,000 procedures to date. Having Sibling With Cardiovascular Disease Associated With Higher CVD Risk, Compared to Other Common Risk Factors Middle-aged adults who have a sibling with cardiovascular disease (CVD) have a 45 percent increased risk for CVD, a risk that is greater than that conferred by having parents with CVD, according to a study in the Journal of the American Medical Association.
Cardiovascular disease in a first-degree relative confers increased risk for CVD, but whether familial CVD is truly an independent risk factor remains controversial. Risk associated with CVD in siblings is uncertain because published estimates are largely derived from case-control studies that generally lack sibling CVD event validation. Furthermore, estimates regarding magnitude of risk associated with a history of sibling CVD vary greatly. Accurate information about familial CVD will have increasing importance in prevention and treatment of CVD in the post-genome era.
Joanne M. Murabito, MD, ScM, of the Framingham Heart Study, Framingham, Mass., and colleagues conducted a study to determine whether the occurrence of a validated sibling CVD event predicted CVD events in a cohort of middle-aged adults, and examined the impact of sibling CVD over and above that of parental CVD. The researchers analyzed data from the Framingham Offspring Study, a part of the Framingham Heart Study, a population-based study initiated in 1948 with the offspring cohort initiated in 1971. Participants were members of the offspring cohort aged 30 years or older, free of CVD, and with at least 1 sibling in the study. All were followed up for eight years.
Among 973 person-examinations in those who had a sibling with CVD group (average age, 57 years) and 4,506 person-examinations in those with no sibling with CVD group (average age, 47 years), 329 CVD events occurred during follow-up. The researchers found that sibling CVD was associated with a 55 percent increased risk for incident CVD; this association persisted even after adjustment for risk factors (45 percent increased risk). The attributable risk percentage for sibling CVD was 27.4 percent; this represents the proportion of the eight-year CVD risk among those in the sibling CVD group that theoretically would not have occurred if members of the group had not had a sibling with CVD.
Using validated events and a prospective design, our study substantially extends the knowledge base regarding the importance of sibling CVD. We observed that sibling CVD confers increased risks of CVD events above and beyond traditional risk factors and parental premature CVD. Thus, sibling CVD should be considered as important as parental premature CVD in the assessment of risk. Further investigation is needed to better understand why sibling history may be a stronger predictor for CVD than parental history, including exploration of the contribution of an early shared environment to increased sibling risk. Moreover, investigation of whether to incorporate sibling CVD as well as parental CVD into existing risk prediction and prevention algorithms is warranted, the authors conclude. Source: JAMA 2005; 294:3117-3123. CoreValve Successfully Initiates First North American Clinical Trial CoreValve announced that follow-up testing conducted several days after the first percutaneous ReValving procedure performed in North America to replace a patient’s defective aortic heart valve showed perfect functioning and anchoring of the new biological heart valve.
Because of ReValving, the 64-year-old high-surgical-risk female patient was able to avoid open-heart surgery. The successful procedure was performed by Dr. Raoul Bonan, an interventional cardiologist at the Montreal Heart Institute, Quebec, Canada. He was assisted by Montreal Heart Institute colleagues Dr. Raymond Cartier, cardiac surgeon, and Dr. Andre Denault, cardiac anesthesiologist. In addition, Dr. Bonan also was assisted by Dr. Jean-Claude Laborde, an interventional cardiologist at Clinique Pasteur, Toulouse, France, who has had extensive clinical experience with the CoreValve Percutaneous ReValving System.
CoreValve has developed a system for replacing an aortic heart valve via a percutaneous approach on a beating heart. Excluding prep time, the second-generation CoreValve Percutaneous ReValving System holds, delivers and places a porcine pericardial-tissue bioprosthesis, via a small, 21 French-sized catheter, during a 15-minutes-or-less procedure performed by an interventional cardiologist in a cath lab setting.
It is important to point out that this patient’s pre-op condition was substantially impaired by a very severe idiopathic pulmonary fibrosis and a significant stenotic aortic heart valve, said Dr. Jacques Séguin, founder, chairman and CEO of CoreValve. In fact, she was not considered a candidate for open-heart surgery by the surgeons at the Montreal Heart Institute because of her high-risk status (i.e., severe idiopathic pulmonary fibrosis) and, in short, this patient was out of options had it not been for CoreValve’s non-surgical ReValving approach to treat her defective aortic heart valve.
Dr. Raoul Bonan noted, In this patient’s particular situation, her cardiac function is now greatly improved as evidenced by post-procedure echocardiography. Considering that, pre-ReValving, she was NYHA functional classification IV, this rapid turnaround of cardiovascular function is dramatic. The fact that we could perform this procedure in a cath lab is further evidence that ReValving has tremendous potential to non-surgically treat the large numbers of patients who have diseased aortic heart valves but who are not good candidates for surgery. Patients Who Could Benefit Most are Least Likely to Take Drugs Regularly Nearly half the coronary artery disease (CAD) patients in a seven-year study admitted they don’t consistently take beta blockers, cholesterol-lowering drugs and other medications that could extend their lives, researchers report in Circulation: Journal of the American Heart Association.
Recent focus has been on ensuring that hospitalized patients are prescribed the proper preventive medications at discharge.
However, attention should also be focused on improving long-term and consistent use of those medications, said Kristin Newby, MD, lead author of the study and associate professor of medicine at Duke University Medical Center in Durham, NC.
Researchers examined changes in the prevalence and consistency of use of evidence-based secondary prevention medications. From 1995-2002, they found the use of therapies with proven survival benefit in CAD patients has improved. However, their use remains less than what is optimally needed, Newby said. Consistent adherence to these medications was lower despite the fact that failure to use them was associated with lower survival rates.
Researchers tapped the Duke Databank for Cardiovascular Disease to analyze medication adherence among 31,750 patients who had undergone a cardiac procedure at Duke, had at least one coronary artery more than 50 percent blocked or had heart bypass surgery. All patients reported their use of aspirin, beta blockers and lipid-lowering drugs in annual surveys.
Patients had to have at least two consecutive surveys returned during the study. Consistent use was defined as reporting use of medications on at least two consecutive occasions and continuing to report use through the end of the study period. Angiotensin-converting enzyme (ACE) inhibitors were reported for patients with and without heart failure. Researchers found the use of all drugs and combinations increased each year. By 2002:
83 percent of patients reported using aspirin; 61 percent reported using a beta blocker; 63 percent reported taking a lipid-lowering drug; 54 percent used aspirin plus beta blocker; and 39 percent reported using all three drugs. However, consistent use during the study period was lower. Researchers found: 71 percent of patients said they used aspirin consistently; 46 percent adhered to beta blockers; 44 percent stuck with a lipid-lowering drug; 36 percent committed to aspirin plus beta blocker; and only 21 percent used all three consistently.
Among patients who had not experienced heart failure, 39 percent reported using ACE inhibitors in 2002; however, consistent use was at 20 percent. Among patients who had experienced heart failure, ACE inhibitor use was 51 percent in 2002 and consistent use was 39 percent.
Consistent use of any of the therapies was associated with higher survival rates. An association was not found, however, among patients who used ACE inhibitors but had not experienced heart failure. Older patients, those with heart failure, smokers and diabetics were least likely to consistently take medication.
These are the groups with the highest risk of poor outcome, and therefore the groups that could potentially benefit the most from sustained therapy, Newby said. As a remedy, she suggested educational and adherence intervention programs implemented via pharmacists and medical care providers.
Researchers acknowledge that because the patients were mostly from North Carolina and southern Virginia, the results may not be representative of the entire U.S. population.
Patients with CAD, their families and their care providers should be familiar with the therapies that improve clinical outcomes and understand the importance of taking them regularly, Newby said. Each of these individuals plays a critical role in ensuring not only that the drugs are prescribed, but also that they continue to be taken during long-term management of CAD.
Newby said that teams of researchers, clinicians, nurses, pharmacists, policy-makers, patients and their families should continue to work on solutions to guarantee improved and consistent long-term use of evidence-based secondary prevention therapies. Administering Stem Cells to Patients With Myocardial Infarction Leads to a Reduction of the Infarct Researchers at the Catholic University of Leuven (The Netherlands), connected with the University Hospital-Gasthuisberg, the Stem Cell Institute Leuven (SCIL), and the Flanders Interuniversity Institute for Biotechnology (VIB), published a breakthrough in the treatment of patients with acute myocardial infarction. Their research shows that the administration of a patient’s own stem cells has a significant positive effect on the heart’s recovery: in the patients studied, the size of the infarct was clearly reduced. The use of stem cells appears to be safe, and to date, no side effects have occurred that can be attributed to the stem cells. The study is being published in The Lancet.
The researchers in Leuven tested the administration of bone marrow stem cells on patients stricken with acute myocardial infarction. Sixty-seven patients in the study underwent balloon angioplasty, and within 24 hours, some patients received an injection of stem cells from their own bone marrow and some received an aqueous (placebo) solution. The study was double-blind.
Improvement in the global functioning of the left ventricle was comparable in both the control group and the stem cell group. However, a clear global improvement in function was found in the sub-group of patients who had been afflicted with the most serious infarctions. Moreover, the reduction of the size of infarct was significantly greater in all patients in the stem cell group and correlated with a better preserved regional left ventricle function. The researchers note that further studies need to be conducted.
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