Clinical and Industry News


Compiled by CathLab Digest

Compiled by CathLab Digest

Cardiovascular Credentialing International to Sunset On-the-Job Training as Qualification Pathway for Invasive Registry Examination

Effective July 1, 2013, Cardiovascular Credentialing International (CCI) will officially remove the RCIS1 Qualification (also referred to as the On-the-Job Training qualification) that allows applicants who ONLY have two (2) years (full-time or full-time equivalent) working in Invasive Cardiovascular Technology, at the time of application, to qualify for CCI’s Invasive Registry examination. The Invasive Registry examination is the required examination for the Registered Cardiovascular Invasive Specialist (RCIS) credential.

The CCI Board of Trustees made this decision to change examination qualifications after consulting with organizations and members of the invasive cardiovascular professional community. CCI recognizes the need for formal education in this field of practice; this is consistent with minimum standards for professional licensure and elevates the overall status of the RCIS credential.

Applicants who wish to apply for the Invasive Registry examination under qualification pathway RCIS1 will have to submit their application by or before June 30, 2013 to be considered. Applications based on the RCIS1 qualification, postmarked after June 30, 2013 will not be processed and will be returned to the applicant instructing him or her to apply under the available qualification pathways.

At this point, there is no foreseen change to the remaining RCIS qualification pathways (RCIS2, RCIS3, RCIS4, and RCIS5). This change in qualification pathways ONLY affects the RCIS credential, no changes to qualifications for any other CCI credential are being made at this time.

The Registered Cardiovascular Invasive Specialist (RCIS) credential is the only internationally recognized credential that demonstrates the obtainment of all the skills and knowledge required to function in the cardiac catheterization laboratory. The RCIS credential is administered and governed by CCI. The RCIS credentialing program is accredited by the American National Standards Institute under the International Standards Organization’s ISO/IEC 17024 accreditation guidelines.

CCI is a not-for-profit corporation established for the purpose of administering credentialing examinations as an independent credentialing agency. CCI began credentialing cardiovascular professionals in 1968.

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Most Heart Attack Patients Needing Procedure Such As Balloon Angioplasty At Another Hospital Not Transferred in Recommended Time

Only about 10 percent of patients with a ST-segment elevation myocardial infarction (STEMI) who need to be transferred to another hospital for a PCI are transferred within the recommended time of 30 minutes, according to a study in the June 22/29 issue of JAMA.

“Primary percutaneous coronary intervention is the preferred method of reperfusion for patients with STEMI, yet approximately 75 percent of hospitals in the United States currently do not have acute PCI capability. Patients with STEMI who present initially to these STEMI referral hospitals are frequently transferred to a STEMI receiving hospital for primary PCI,” according to background information in the article. “Most important, the duration of time from arrival to discharge at the first hospital (i.e., the door-in to door-out [DIDO] time) is largely unknown. Furthermore, patient characteristics related to substantial delays in DIDO time, as well as the effect of this initial delay on subsequent treatment and outcomes, are also uncertain.” The DIDO measure is increasingly being advocated as an important metric of processes of care to expedite reperfusion, and a national benchmark of less than 30 minutes has been recommended.

Tracy Y. Wang, MD, MHS, MSc, of Duke University Medical Center, Durham, NC, and colleagues conducted a study to examine the time to reperfusion and patient outcomes associated with a DIDO time of 30 minutes or less. The study included data on 14,821 patients with STEMI transferred to 298 STEMI receiving centers for primary PCI in the Intervention Outcomes Network Registry (ACTION) Registry-Get With the Guidelines between January 2007 and March 2010.

Among the STEMI patients in the study transferred to a STEMI receiving hospital for primary PCI, the median (midpoint) DIDO time was 68 minutes. Only 1,627 patients (11 percent) had a DIDO time of 30 minutes or less; 56 percent had a DIDO time of greater than 60 minutes and 35 percent had a DIDO time of greater than 90 minutes. Independent patient characteristics associated with a DIDO time greater than 30 minutes included older age, female sex, off-hours presentation, and nonemergency medical services transport to the first hospital.

The researchers found that patients with a DIDO time of 30 minutes or less were more likely to undergo primary PCI after arriving at the STEMI receiving hospital compared with patients with a DIDO time greater than 30 minutes (95.9 vs. 90.5 percent). Overall door-to-balloon (D2B) time was significantly shorter for patients with a DIDO time of 30 minutes or less compared with those with a DIDO time greater than 30 minutes (median [midpoint], 85 vs. 127 minutes). The percentage of patients with an overall D2B time of 90 minutes or less was significantly higher for patients with a DIDO time of 30 minutes or less compared with those with a DIDO time greater than 30 minutes (60 percent vs. 13 percent); similar results were observed for the percentage of patients achieving an overall D2B time of 120 minutes or less.

During the study period, the researchers observed a 5.5 percent in-hospital mortality rate that was significantly higher among patients with a DIDO time greater than 30 minutes (5.9 percent) compared with patients who had a DIDO time of 30 minutes or less (2.7 percent).

“DIDO time is a new reperfusion performance measure for patients with STEMI who require interhospital transfer for primary PCI. Our study shows that patients with a DIDO time of 30 minutes or less are more likely to achieve an overall D2B time of less than 90 minutes and are associated with lower risk-adjusted mortality compared with patients who had a DIDO time greater than 30 minutes, thus affirming the importance of DIDO time as a metric for reperfusion quality. Significantly, the majority of transferred patients with STEMI nationwide do not meet the recommended 30-minute benchmark, suggesting that further attention and improvement of this performance measure will translate into substantial improvement in the timeliness of primary PCI and clinical outcomes for transferred STEMI patients,” the authors write.

Source: JAMA 2011;305[24]2540-2547.


Boston Scientific Announces Global Launch of Mustang PTA Balloon Catheter

Boston Scientific Corporation announced the global launch of its Mustang™ PTA Balloon Catheter, a deliverable 0.035-inch percutaneous transluminal angioplasty (PTA) catheter designed for a wide range of peripheral angioplasty procedures.  The Company plans to launch the product immediately in the U.S., Europe and other international markets.

Boston Scientific developed the Mustang PTA Balloon Catheter to meet physician needs for a low-profile, high-pressure balloon catheter in a wide range of sizes.  It is the first to use Boston Scientific’s NyBax™ Balloon Material, a proprietary co-extrusion of nylon and Pebax® polymers engineered to provide high-pressure, non-compliant dilatation in a low-profile balloon. The Mustang Balloon Catheter offers excellent rated burst pressure (up to 24 atmospheres) and is the only 7 x 200 mm balloon compatible with a 5 French introducer sheath.  It is available in 203 sizes.


Size, Strength of Heart’s Right Side Differs by Age, Gender, Race/Ethnicity

The size and pumping ability of the right side of the heart differs by age, gender and race/ethnicity, according to the first large imaging study of the right ventricle.

The study, reported in Circulation: Journal of the American Heart Association, also suggests that understanding the fundamental differences in the right side of the heart gives doctors and researchers a basis for determining what is abnormal. The researchers think that changes in right ventricle size and function may be a sign of cardiopulmonary disease.

“The right ventricle pumps blood to the lungs to pick up oxygen, so all types of lung diseases — chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, pulmonary hypertension, and sleep apnea — can affect the right side of the heart,” said Steven Kawut, MD, MS, study author. “These results show underlying differences in people without clinical heart disease and could explain the variability of the right ventricular response in people with cardiopulmonary disease.”

The researchers found that the right ventricle is:

  • Smaller but pumps harder in older adults.
  • Larger in men than women.
  • Smaller in African-Americans and larger in Hispanics, compared with Caucasians.

In most studies on the heart, researchers have focused on the more-easily-imaged left ventricle, the region of the heart affected by systemic high blood pressure and other common conditions. Some of the relationships between gender, age and race/ethnicity found in the new study are different from what’s known about the left ventricle. For example, the left ventricle increases in mass with age and is larger in African-Americans than Caucasians.

“It’s not surprising that the relationships are different, since the right and left ventricles differ in their development in the embryo, their shape, and the area of the body they serve,” said Kawut, associate professor of medicine and epidemiology and director of the pulmonary vascular disease program at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia.

The researchers examined magnetic resonance images of the right ventricles of 4,204 men and women, average age 61.5, participating in the Multi-Ethnic Study of Atherosclerosis (MESA). MESA is a multicenter research project tracking the development of cardiovascular disease in 6,814 Caucasians, African-Americans, Hispanics and Chinese-Americans who did not have clinically-diagnosed heart disease at the beginning of the study.

Using norms derived from the study, 7.3 percent of the participants would be considered to have right ventricular hypertrophy and 5.9 percent to have dysfunction of the right ventricle.

If validated in future research, the norms can help physicians identify patients with abnormal right ventricle structure or function.

“If right ventricle abnormalities are found, it should heighten suspicion for underlying cardiopulmonary disease,” Kawut said.

The new findings may help test effectiveness of treatments that could be developed for right ventricle dysfunction.

“This study is a first step, but we need to see how the right ventricle changes over five to 10 years in these ‘normal’ people, many of whom have COPD, sleep apnea and other common lung problems,” Kawut said.

The National Heart, Lung, and Blood Institute funded the study.


Omega-3 May Cut Risk of Artery Disease, Heart Attacks for Patients With Stents

Omega-3 fatty acids, combined with aspirin and clopidogrel, significantly changed the blood-clotting process and may reduce the risk of heart attacks in patients with stents in their heart arteries, according to research reported in Arteriosclerosis, Thrombosis and Vascular Biology: Journal of the American Heart Association.

Foods rich in omega-3, such as salmon and other oily fish, have been previously shown in other studies to reduce the risk of heart problems in people with coronary artery disease. In this study, the participants were given the pill form of omega-3 (1,000 milligrams n-3 PUFA daily) and were encouraged to increase their consumption of oily fish.

“There are no other studies on omega-3 effects in patients who were already being treated with optimal medical therapy after stent placement,” said Grzegorz Gajos, MD, PhD, lead author and assistant professor of cardiology at Jagiellonian University in Krakow, Poland. “This was a proof of concept study. We were looking for any effect and what it might be.”

The Omega-PCI Study — a double-blind, placebo-controlled trial — found patients who received the omega-3 pills with aspirin and clopidogrel had blood clots more susceptible to destruction than patients who received only the two blood thinners. The research team particularly targeted the protein fibrin and the interlaced structure it forms in coagulated blood.

Gajos and colleagues examined findings from 54 patients (41 men, 13 women, average age 62.8 years) who participated in the trial, conducted at John Paul II Hospital in Krakow.

This study evaluated the effects of omega-3 in patients with stable coronary artery disease who had received a stent. Previously, the researchers had reported that adding omega-3 to clopidogrel after stenting significantly lowered the platelet response in clotting.

For this study researchers randomly selected 24 patients as controls and 30 for treatment before their heart procedures. Both groups received the same daily doses of aspirin and clopidogrel for four weeks after stenting. The treatment group received 1,000 milligrams of omega-3 daily and the controls received a placebo each day.

The study showed that, in comparison with the control group, the omega-3 treated patients:

  • Produced less thrombin.
  • Formed clots with an altered and favorable structure — including larger pores — that made them easier to disrupt. Therefore the clot-destruction time was 14.3 percent shorter. This might prove important in protecting patients, especially those with drug-eluting stents who occasionally develop potentially fatal late clots.
  • Had less oxidative stress.
  • Showed no significant changes in fibrinogen and clotting factor (II, XIII) levels. Fibrinogen is a protein produced by the liver. This protein helps stop bleeding by helping the formation of blood clots. Fibrinogen is converted by thrombin into fibrin during blood coagulation. The implication of this finding suggests that changes in the three biomolecules had no role in reducing the treatment group’s thrombin generation and altering the structure of blood clots that formed, Gajos said.

Study participants experienced only mild adverse side effects and the number of events did not vary significantly between the two groups. There were not enough participants to assess clinical benefit from the changes in the clotting process.

Another limitation of the study was the inability to extrapolate the findings to healthy individuals, those with a high coronary artery disease risk, and those not taking aspirin and/or clopidogrel.

“We are planning a larger follow-up study that will include outcomes and continue indefinitely,” Gajos said.


Low-Carb, Higher-Fat Diets Add No Arterial Health Risks to Obese People Seeking to Lose Weight

“Overweight and obese people appear to really have options when choosing a weight-loss program, including a low-carb diet, and even if it means eating more fat,” says the studies’ lead investigator exercise physiologist Kerry Stewart, EdD.

Stewart, a professor of medicine and director of clinical and research exercise physiology at the Johns Hopkins University School of Medicine and its Heart and Vascular Institute, says his team’s latest analysis is believed to be the first direct comparison of either kind of diet on the effects to vascular health, using the real-life context of 46 people trying to lose weight through diet and moderate exercise. The research was prompted by concerns from people who wanted to include one of the low-carb, high-fat diets, such as Atkins, South Beach and Zone, as part of their weight-loss program, but were wary of the diets’ higher fat content.

In the first study, the Johns Hopkins team studied 23 men and women, weighing on average 218 pounds and participating in a six-month weight-loss program that consisted of moderate aerobic exercise and lifting weights, plus a diet made up of no more than 30 percent of calories from carbs, such as pastas, breads and sugary fruits.  As much as 40 percent of their diet was made up of fats coming from meat, dairy products and nuts.

This low-carb group showed no change after shedding 10 pounds in two key measures of vascular health: finger tip tests of how fast the inner vessel lining in the arteries in the lower arm relaxes after blood flow has been constrained and restored in the upper arm (the so-called reactive hyperemia index of endothelial function), and the augmentation index, a pulse-wave analysis of arterial stiffness.

Low-carb dieters showed no harmful vascular changes, but also on average dropped 10 pounds in 45 days, compared to an equal number of study participants randomly assigned to a low-fat diet. The low-fat group, whose diets consisted of no more than 30 percent from fat and 55 percent from carbs, took on average nearly a month longer, or 70 days, to lose the same amount of weight.

“Our study should help allay the concerns that many people who need to lose weight have about choosing a low-carb diet instead of a low-fat one, and provide re-assurance that both types of diet are effective at weight loss and that a low-carb approach does not seem to pose any immediate risk to vascular health,” says Stewart. “More people should be considering a low-carb diet as a good option,” he adds.

Because the study findings were obtained within three months, Stewart says the effects of eating low-carb, higher-fat diets versus low-fat, high-carb options over a longer period of time remain unknown.

However, Stewart does contend that an over-emphasis on low-fat diets has likely contributed to the obesity epidemic in the United States by encouraging an over-consumption of foods high in carbohydrates. He says high-carb foods are, in general, less filling, and people tend to get carried away with how much low-fat food they can eat. More than half of all American adults are estimated to be overweight, with a body mass index, or BMI, of 26 or higher; a third are considered to be obese, with a BMI of 30 or higher.

Stewart says the key to maintaining healthy blood vessels and vascular function seems — in particular, when moderate exercise is included — less about the type of diet and more about maintaining a healthy body weight without an excessive amount of body fat.

Among the researchers’ other key study findings, to be presented separately at the conference, was that consuming an extremely high-fat McDonald’s breakfast meal, consisting of two English muffin sandwiches, one with egg and another with sausage, along with hash browns and a decaffeinated beverage, had no immediate or short-term impact on vascular health. Study participants’ blood vessels were actually less stiff when tested four hours after the meal, while endothelial or blood vessel lining function remained normal.

Researchers added the McDonald’s meal challenge immediately before the start of the six-month investigation to separate any immediate vascular effects from those to be observed in the longer study. They also wanted to see what happened when people ate a higher amount of fat in a single meal than recommended in national guidelines.

Previous research had suggested that such a meal was harmful, but its negative findings could not be confirmed in the Johns Hopkins’ analysis.  The same meal challenge will be repeated at the end of the study, when it is expected that its participants will still have lost considerable weight, despite having eaten more than the recommended amount of fat.

“Even consuming a high-fat meal now and then does not seem to cause any immediate harm to the blood vessels,” says Stewart.  However, he strongly cautions against eating too many such meals because of their high salt and caloric content.  He says this single meal — at over 900 calories and 50 grams of fat — is at least half the maximum daily fat intake recommended by the American Heart Association and nearly half the recommended average daily intake of about 2,000 calories for most adults.

All study participants were between the age of 30 and 65, and healthy, aside from being overweight or obese. Researchers say that in the first study, because people were monitored for the period they lost the same amount of weight, any observed vascular differences would be due to what they ate.

Funding for the study was provided by the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health (NIH), with additional assistance from the Johns Hopkins Bayview Institute for Clinical Translational Research, also funded by the NIH.


Carotid Artery Interventions for Cerebrovascular Disease Compared

New data in the June 2011 issue of the Journal of Vascular Surgery®, the official publication of the Society for Vascular Surgery®, reveals that carotid endarterectomy may be the preferred treatment for women who require intervention for cerebrovascular disease. The study notes that the results of carotid angioplasty and stenting (CAS) have not been extensively analyzed in female patients.

According to Caron B. Rockman, MD, lead author and Associate Professor of surgery at New York University Medical Center in New York City, a total of 54,658 cases were reviewed from the Nationwide Inpatient Sample between 2004 and 2005. “A total of 94.2% of the patients had carotid endarterectomy while 5.8% had CAS,” said Dr. Rockman. “Women comprised 42.3% of the analyzed cases and were significantly less likely to undergo CAS than men (5.4 vs. 6.1%).”

Despite concerns from early, randomized trials that women might have higher rates of complications than men after undergoing carotid endarterectomy, in the current study, researchers noted that women and men had equivalent rates of perioperative stroke when undergoing carotid endarterectomy (1.0 vs. 1.0%) and CAS (2.7 vs. 2.%).

Overall, women and men were equally likely to be symptomatic with a previous TIA (transient ischemic attack) or stroke before undergoing their carotid artery procedure (5.3 vs. 5.3%). It was noted that symptomatic women had a significantly higher overall rate of perioperative stroke than symptomatic men (3.8 vs. 2.3%). Dr. Rockman added that although women had a slightly higher complication rate, it was still well within the acceptable range for symptomatic patients undergoing cerebrovascular intervention.

More importantly, asymptomatic women had a significantly lower perioperative stroke rate after carotid endarterectomy than after CAS (0.9 vs. 2.1%). Rates of perioperative stroke additionally showed a trend favoring carotid endarterectomy as opposed to CAS among symptomatic women (3.4 vs. 6.2%) as well.

Researchers noted that the benefit of carotid endarterectomy in female patients has been questioned by various randomized, prospective trials, particularly in asymptomatic cases; several have noted an increase in perioperative stroke among women after carotid endarterectomy. However, they added that the outcome of carotid angioplasty and stenting had not been extensively examined in women.

“An unexpected finding from our current analysis was that there appears to be a sex-based selection bias with regard to the type of carotid intervention performed,” said Dr. Rockman. “Men were more likely to undergo CAS than women (6.1 vs. 5.4%) and asymptomatic men were more likely to undergo CAS than asymptomatic women (5.8 vs. 4.8%). In contrast to these findings, symptomatic male patients were less likely to undergo CAS than symptomatic female patients (11.9 vs. 13.5%).”  The precise reasons for these potential biases remain unclear at this time.     

“Our analysis reveals that the concern regarding an increased perioperative stroke rate after carotid endarterectomy among asymptomatic women appears to be unfounded,” added Dr. Rockman. “Overall, regardless of symptomatic status or the procedure performed, female patients undergoing carotid intervention had a nearly equivalent outcome compared with their male counterparts. Our findings suggest that women do not have an increased rate of perioperative complications as compared to men after intervention for carotid occlusive disease and that the indications for carotid intervention should not be influenced by their sex.”  Furthermore, carotid endarterectomy may be the preferred treatment in women who warrant intervention for cerebrovascular disease unless compelling reasons exist to perform CAS.


Hospital Quality Affects Wait Time for PCI, Black Patients Affected

Black patients having a heart attack wait longer at hospitals than white patients to get advanced procedures that will restore blood flow to their hearts, according to a University of Michigan Health System study. The differences in care may be explained by hospital quality, rather than the race of individual patients. Black patients were much more likely to go to slow hospitals than were whites, and as a result waited six hours longer to get life-saving procedures. Most elderly black patients received care in a small number of hospitals that take longer to transfer their patients, regardless of race, according to the U-M study published in the July issue of Medical Care, the journal of the American Public Health Association.

“These data suggest that an individual’s race may play much less of a role in generating differences in care, while the hospitals where black patients often go may be even more important,” says study lead author Colin R. Cooke, MD, a Robert Wood Johnson Clinical Scholar at the University of Michigan.

Researchers analyzed nearly 26,000 Medicare patient records for the study that looked at how hospitals across the nation may influence racial differences in health care.

The U-M authors note that the causes for delays in hospitals that serve a greater number of black patients is not clear, but based on prior research speculate that quality of care at these hospitals may be worse.

Strapped by financial constraints, safety-net hospitals may forego development of a ‘quality improvement culture’ or limit adoption of computer order entry or electronic medical records, infrastruture which may improve the quality of care.

The most important step in improving cardiovascular care for black patients is addressing organizational issues and resources at hospitals where black patients seek medical care, authors say.


Solent Omni Introduced to AngioJet® Solent™ Family of Thrombectomy Catheters

Medrad Interventional (Indianola, Penn.) has announced the most recent addition to the Solent Family of thrombectomy catheters, designed for large, difficult-to-remove thrombus for peripheral vasculature. The Solent Omni is available in a 120-cm length, offering a longer reach as compared to the 90-cm Solent Proxi. The Solent catheters are enabled for Power-Pulse Delivery, allowing them to be used to power-infuse lytic into the thrombus. The family is part of the growing portfolio of specialized thrombectomy devices available for use with the AngioJet Ultra System. In response to requests from interventionalists, the Solent catheters offer the highest clot-removing power in the AngioJet range and allow swapping of guidewires during the procedure. A port with stop cock has been added to the catheter’s hub to facilitate in situ contrast injection. The Solent catheters are also constructed with flexible, polymer-clad spiral shafts and hydrophilic coating on the distal section to improve handling compared to earlier designs.

Like all AngioJet thrombectomy catheters, the Solent catheters are based on the AngioJet Cross-stream® technology — utilizing high-speed saline jets contained inside the catheter tip to create a powerful low-pressure zone that entrains and removes clot.

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