News from the American Heart Association Meeting (AHA)

The ACC and AHA Launch National Alliance To Reduce Door-to-Balloon (D2B) Times

The American College of Cardiology (ACC), together with the American Heart Association (AHA) and other key national healthcare organizations, announced the launch of its latest quality campaign, Door to Balloon (D2B): An Alliance for Quality. A Guidelines Applied in Practice (GAP) Program, the D2B campaign is aimed at improving the timeliness of lifesaving therapy for patients with heart attacks at U.S. hospitals that perform emergency angioplasty.

Previously published guidelines developed by the ACC and the AHA recommend that hospitals treating STEMI patients with percutaneous coronary intervention (PCI) should reliably achieve a door-to-balloon time of 90 minutes or less. However, accomplishing this level of performance is an organizational challenge and many patients are not treated within the guideline recommendation. Thus, improving timeliness of treatment represents an important opportunity to improve the quality of patient care.

Harlan M. Krumholz, MD, SM, FACC, chair of the D2B Working Group and a multidisciplinary team conducted a study funded by the National Heart, Lung and Blood Institute in which 365 hospitals were surveyed to identify strategies that were significantly associated with a faster door-to-balloon time. Data from this study were simultaneously presented at AHA’s Annual Scientific Sessions in Chicago and published in the New England Journal of Medicine.

Several evidence-based strategies have been identified to assist hospitals in reducing their door-to-balloon times. The strategies involve multiple departments and require a systems approach. They include:

The emergency medicine physicians activate the catheterization laboratory (cath lab)

A single call activates the cath lab

The cath lab team arrives and is ready within 20-30 minutes

Real-time data feedback in the emergency department and the cath lab

Senior management commitment

Team-based approach

Over the coming months, participating hospitals will receive an implementation manual and tool kit, as well as information on how to best construct the team needed to implement the changes; what the roles and responsibilities of each member should be; and how to identify the point person for the project within each primary PCI hospital.

An update on the campaign will be given at the ACC’s Annual Meeting, ACC.07, in New Orleans from March 24-27, 2007.

Most U.S. Hospitals too Slow in Handling Heart Attacks

Most U.S. hospitals do not move fast enough to treat heart attack victims with life-saving emergency angioplasties, according to a study. The study, published in the November 16 New England Journal of Medicine showed that many hospitals did not follow federal guidelines to carry out the procedure in a timely fashion.

The faster doctors carry out the procedure, the higher the probability of survival, according to the study, which coincides with a meeting of the American Heart Association in Chicago.

Researchers from Yale School of Medicine identified several ways to speed up door-to-balloon time. The study, which included 365 U.S. hospitals, showed that the delay in performing angioplasty varied from between 55 and 120 minutes after arriving at the emergency room.

Federal recommendations are for less than 90 minutes. The risk of death rises 42 percent if the procedure is delayed at least 30 minutes, according to the researchers. Slightly more than one-third of heart attack victims in the United States obtain an angioplasty within the first 90 minutes. To gain time, the researchers urge activating the catheterization laboratory while the victim is on his way to the hospital, as well as improving coordination of hospital personnel and having a cardiologist on round-the-clock duty.

Despite the effectiveness of these strategies, a minority of the hospitals surveyed were using them, even though many of the strategies were feasible and could be immediately implemented, said lead author Elizabeth Bradley.

The publication of the research also coincides with the launch of a new campaign by the American College of Cardiology and the American Heart Association to speed up angioplasties and encourage hospitals to implement the strategies. One-third of the approximately 865,000 annual heart attacks in the United States can be treated with angioplasty.

Late Reperfusion Fails to Reduce Cardiovascular Complications

Balloon angioplasty plus stenting failed to reduce major cardiovascular complications in patients who had the procedure three to 28 days after a heart attack, researchers reported at the American Heart Association’s Scientific Sessions 2006. Results of the Occluded Artery Trial (OAT), a National Heart, Lung, and Blood Institute (NHLBI) funded international, randomized clinical study, were presented in a late-breaking clinical trials session. The trial included 2,166 people and is the largest and longest study to compare very late reperfusion to medication alone.

OAT was designed to help resolve a controversy about treatment of over one hundred thousand heart attack survivors in the United States alone each year: whether late opening of blocked coronary arteries would provide any long-term benefits to stable patients, said Judith S. Hochman, MD, OAT study chair and Harold Snyder Family Professor of Cardiology, clinical chief and director of the Cardiovascular Clinical Research Center at the New York University School of Medicine in New York City.

Treatment to reopen totally blocked arteries reduces damage and improves survival if given during the first 12 hours of a heart attack, and up to 36 hours in selected unstable patients. However, an estimated one-third of eligible patients do not receive reperfusion therapy in that timeframe because many of them arrive at the hospital after the treatment window has closed.

In the United States, many physicians favor mechanical opening of totally occluded arteries in stable patients even after the treatment window has closed despite the lack of evidence based on large, randomized, controlled trials on the issue, said Gervasio A. Lamas, MD, study co-chair and director of Cardiovascular Research and Academic Affairs at Mount Sinai Medical Center in Miami, Fla.

OAT tested the hypothesis that percutaneous coronary intervention (PCI) with stenting would be better than medication alone if performed three to 28 days after a heart attack in stable patients who were at increased risk of long-term events death, repeat heart attack and heart failure and who had a totally occluded coronary artery causing the heart attack. Most of these patients had only one coronary artery with severe disease. The primary endpoint was a composite of death, repeat heart attack or heart failure after an average of three years of follow up.

Stenting was required when feasible, with investigators free to choose bare-metal or drug-eluting stents. Most patients did not receive drug-eluting stents. The researchers followed the patients for an average of three years by telephone or through clinic visits and used medical records to check on the clinical events of interest. The endpoints were verified by an independent classification central committee. Maryland Medical Research Institute was the data coordinating center, led by Genell L. Knatterud, PhD.

The study results show no statistically significant differences between the late PCI and medication group in the occurrence of death, heart attacks or heart failure. However, the researchers found an unsettling trend toward more heart attacks in the late PCI group than in the medication group. PCI-assigned patients tended to have excess rates of repeat heart attack, including non-procedure-related events. In addition, elevation of cardiac markers was significantly more common in the PCI group soon after randomization to that treatment arm.

Although the rate of repeat heart attacks did not reach the level of statistical significance, the trend is worrisome, Hochman said. Further analysis and longer follow-up is required to understand the clinical consequences of these heart attacks. These unexpected results are remarkably consistent among all subgroups, including those at highest risk of adverse left ventricular remodeling, such as those with low ejection fraction.

There were fewer patients with angina in the PCI-assigned group at four months and at one year. However, the overall occurrence of angina was low and declined in both groups, and at three years there was no significant difference between groups in the proportion of patients with angina.

OAT included a substudy called the Total Occlusion Study of Canada (TOSCA)-2 Trial. It used repeat pictures of the coronary arteries and left ventricle in the hearts of a subgroup of 381 subjects in the PCI and medication groups, which was led by Vladimir Dzavik, MD., University Health Network, Toronto General Hospital, Canada and Christopher E. Buller, MD, Vancouver General Hospital, Canada. This study found that the opened artery stayed open at one year in most patients who had the angioplasty but their heart function was not better than the medication group. A subset of those who had additional measurements showed less adverse enlargement of the heart in the PCI group. However, this did not translate into clinical benefit. There may be competing processes whereby repeat heart attacks offset this potential benefit.

Results of the 2,166-patient OAT Trial found no reduction in major cardiovascular events over an average follow-up of three years and a signal of excess non-fatal heart attack when routine PCI was performed on stable patients who still have an occluded IRA following a heart attack, Hochman said. Our findings should lead to lower rates of unnecessary coronary interventions in this specific group of stable patients, which should result in substantial healthcare cost savings. Early treatment of heart attacks remains a critically important therapy.

Drug-eluting Stents May Restore Blood Flow to Lower Legs

Drug-eluting stents may be a feasible and safe treatment option to restore and maintain blood flow through small occluded vessels in the lower leg, according to a small, one-year study reported at the American Heart Association’s Scientific Sessions 2006.

Initial experience with 10 patients in this study indicates that drug-eluting stents reduce the risk of restenosis. There was no restenosis in 90% of participants. This is in contrast to the expected 50% of patients who have required treatment for restenosis in previous studies, researchers said.

This is a very common problem that is associated with significant morbidity and mortality, said Arthur G. Grant, MD, the study’s lead author and an interventional cardiology fellow at Ochsner Medical Center in New Orleans. It is something that we need to do a better job of treating. This is an exciting first step toward getting some answers to a difficult problem.

In this study, Grant reported findings from the first 10 patients, all of whom have been followed for at least a year. One patient had claudication and nine had severe arterial narrowing that placed them at risk of amputation. Nine patients didn't require additional procedures to open the artery after stent placement and haven’t had complications for at least a year. The one treatment failure involved a patient who developed a blood clot in the stent three weeks after it was placed and required emergency angioplasty to restore blood flow.

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