American College of Cardiology

  
 


Archive of issues

 

 

 EDWARD A. GEISER, MD
ACC '04 Program Committee Chair

JAMIE B. CONTI, MD
ACC '04 Program Committee Co Chair

    
 

In this Issue:
 Dr. Pepine reflects on His Year as ACC President
Late-Breaking Clinical Trials Examine New Therapies for Cardiovascular Disease
Health Care and the 2004 Elections
Young Investigators Awards
Health Policy Symposium Sheds Light On Off-Label Use
Distinguished Awardees Honored at Convocation
Experts Explore New Developments in Nuclear Cardiology
Slate of Officers and Trustees Announced
ACCF Cosponsors Intervention 2004™

Dr. Pepine Reflects on His Year as ACC President
Carl J. Pepine, MD, MACC, completed his term as ACC President last night at Convocation. He shared some of his thoughts on the past year and what lies ahead for the College.

What do you consider the highlight of your year as president?

All the circumstances that led up to and include the 35th Bethesda Conference have been vital to the future of cardiovascular medicine. The gathering and presentation of the data that prove the workforce shortage exists, and consideration of all the factors that created it and how it affects our patient care, our practice, and the numbers attracted to our specialty is really essential to moving forward—both as individual physicians and as a professional association. Finding solutions to the challenges that lie ahead on that will continue to demand our focused attention. The workforce situation affects all of us—today, it affects the quality of our professional and personal lives, and in the long term it will affect our retirement and the future of our specialty. But when supply doesn’t react to market demand, there is always a cost consequence. Unfortunately, cardiovascular care and patients will bear this cost.

Another milestone, of course, is the decision to relocate Heart House to downtown Washington, D.C. This step in the College’s development is going to move us closer to key leaders we need to align ourselves with as national health policy continues to evolve. Many of our current advocacy campaigns will benefit from the proximity we hope to achieve with government officials and elected leaders. So that was another important step taken this year.

A third major initiative underway is the development of a code of ethical conduct to guide us in the complex relationships that develop in the contemporary practice, business, and institutional environments we work in. Distinct guidelines that spell out acceptable conduct and acceptable business relationships are going to become a valuable tool for the College in the future.

Finally, we conducted our first-ever community event to give back something to the city hosting our Annual Scientific Session. We conducted cardiovascular health screenings and increased awareness of CV disease in women.

What issues will you work on as immediate past president?

We have so much in front of us: medical liability reform, reimbursement issues. These will continue to engage me.

All four of the issues I mentioned earlier grew out of my natural interest in their outcomes. That won’t change. I remain chairman of the Property Task Force and will continue to be involved in relocating the Heart House of the Future. And I’ll certainly continue to actively address the workforce crisis in cardiovascular medicine as a member of the team to implement the recommendations from the Bethesda Conference. It’s an issue that requires our vigilant attention, and the solutions aren’t yet fully formed with specifics.

Are there any special thanks or acknowledgments you’d like to make?

Because this meeting in New Orleans has been unique for so many reasons, I’d like to acknowledge the fact that this is the first meeting in several years to be conducted under more “normal” circumstances, with less urgent security issues at the forefront, and a more optimistic economic outlook. The result is attendance beyond what we’ve experienced in recent years, and that’s very gratifying for everyone concerned. And being in this laid-back, warm, and welcoming city is a wonderful change of pace for many of us. In addition, the College’s campaign to target women about becoming aware of their cardiovascular risk factors couldn’t ask for a better spokesperson or a better face than that of Mrs. Bush, who so graciously accepted our invitation to speak about a cause she genuinely cares about and has helped illuminate. Her visit to New Orleans underscores the fact that this city has one of the highest rates of heart disease in the nation, and that women, their physicians, and their family members can actually make a difference in changing that statistic.

Of course, I’d like to acknowledge the support I’ve received from the Board of Trustees, the Board of Governors, and all the volunteers who devote countless hours to the ACC’s committees, task forces, and working groups. Without their hard work, we could not have accomplished so much this year: new practice guidelines, new educational products, new education programs, and of course, this very successful Annual Scientific Session that has gathered our community together for our very crucial exchange of science, technology, results of clinical trials, case presentations, and so much more. It’s been a pleasure to work with so many fine professionals, within our membership and on the ACC staff.

Late-Breaking Clinical Trials Examine New Therapies for Cardiovascular Disease
The Late-Breaking Clinical Trials II session on Tuesday featured eight trials evaluating a variety of drugs and therapies to manage cardiovascular risk factors and treat CV disease, including chronic heart failure, hypertension, and mitral valve regurgitation.

STRATUS-US and RIO-LIPIDS Trials
The STRATUS-US Trial (Smoking Cessation in Smokers Motivated to Quit) is multicenter placebo-controlled trial designed to evaluate the effectiveness of rimonabant, a new drug that targets the endocannaboid system, in helping motivated smokers to quit smoking and thereby reduce their risk of developing major cardiovascular events.

According to Robert M. Anthenelli, MD, from the University of Cincinnati College of Medicine, who presented the study, significantly more smokers given a 20 mg dose of rimonabant quit smoking than those given a placebo (27.6 percent versus 16.1 percent). The drug also markedly reduced post-cessation weight gain in the treated group.

A related study, RIO-LIPIDS (Weight Reducing and Metabolic Effects in Overweight/Obese Patients with Dyslipidemia), reported by Jean-Pierre Després, PhD, from the Laval Hospital Research Center in Quebec, found that 20 mg rimonabant not only resulted in a significant weight loss in treated patients but also reduced their serum triglyceride levels, number of small low-density lipoprotein particles, C-reactive protein concentrations, and adiponectin levels.

Myoblast Transplantation
Nabil Dib, MD, from the Arizona Heart Institute in Phoenix, reported a long-term follow-up study of the feasibility and safety of autologous skeletal myoblast transplantation for patients undergoing coronary artery bypass graft surgery. This phase I trial evaluated the results of transplanting skeletal myoblasts, cells thought to be ischemia resistant, during bypass surgery in 22 patients with coronary artery disease. Dr. Nib said that the procedure was found to be feasible and safe and that further trials are warranted. The transplanted cells were able to regenerate scarred myocardial tissue and make it viable after ischemic injury.

WATCH Trial
The results of the WATCH Trial (Warfarin and Antiplatelet Trial in Chronic Heart Failure) were presented by Barry M. Massie, MD, from the University of California, San Francisco, who said that this trial of warfarin versus aspirin and aspirin versus clopidogrel for patients with symptomatic heart failure was discontinued early, in June 2002, because of low enrollment. The study was designed to include 4,500 patients but only 40 percent of that number were actually enrolled.

At the time the trial was discontinued, results showed no significant difference among the agents studied in the trial’s endpoints of all-cause mortality, nonfatal myocardial infarction, and nonfatal stroke. However, warfarin was associated with fewer hospitalizations of heart failure patients than aspirin. Additional studies are needed, concluded Dr. Massie.

Endovascular Mitral Valve Repair
A Phase I trial of percutaneous mitral valve repair using the edge-to-edge surgical technique showed that the procedure is technically possible and successful in reducing mitral regurgitation in some patients, according to Ted Feldman, MD, from Evanston Northwestern Hospital in Evanston, Ill., who reported the study yesterday.

The novel endovascular, catheter-based procedure uses a special device that places a clip in the mitral valve to treat prolapse. Ten patients have been treated so far. In one patient, the clip detached, and three other patients had the clip removed surgically because it was unable to reduce regurgitation. The remaining six patients had successful procedures and showed evidence of reduced mitral regurgitation for up to six months.

SYNERGY Trial
The SYNERGY Trial (Superior Yield of the New Strategy of Enoxaparin, Revascularization and Glycoprotein IIb/IIIa Inhibitors) evaluated the use of enoxaparin versus unfractionated heparin in 10,027 patients at high risk for acute coronary syndrome.

The study found that enoxaparin was not superior to unfractionated heparin but it was as effective and that enoxaparin can be considered a safe and effective alternative to unfractionated heparin for patients at high risk of acute coronary syndrome, said James Ferguson, MD, from St. Luke’s Episcopal Hospital, Houston. However, enoxaparin was associated with a higher incidence of major bleeding than heparin.

INVEST Trial
Franz H. Messerli, MD, from the Ochsner Clinic in New Orleans, reported results from the INVEST Trial (International Verapamil SR-Trandolapril Study) showing that low diastolic blood pressure is associated with increased mortality and cardiovascular morbidity — the socalled J-shaped curve phenomenon.

All 22,000 patients in the study were treated for coronary artery disease and hypertension. The endpoints were first occurrence of death, nonfatal myocardial infarction, and non-fatal stroke. Dr. Messerli said that the incidence of myocardial infarction and stroke began to increase as the patients’ diastolic blood pressure fell below 84 mmHg and kept rising as diastolic pressure went lower. Previous coronary revascularization, however, seemed to have a protective effect.

ALLHAT Study
The ALLHAT study (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) looked at racial differences in response to the treatment of hypertension among 42,418 patients using angiotensin-converting enzyme inhibitors and found that ACE inhibitors are significantly less effective at lowering blood pressure and reducing the risk of heart failure and stroke in blacks than in non-blacks.

The black patients treated with ACE inhibitors had 19 percent higher stroke rates and 14 percent higher mortality rates than black patients treated with diuretics, said Curt D. Furberg, MD, from Wake Forest University School of Medicine, Winston-Salem, N.C. He concluded that ACE inhibitors cannot be recommended as first-line therapy for hypertensive black patients, but that they are effective therapy for non-blacks.

Health Care is “Upper Second Tier” Issue of 2004 Election
 If you haven’t yet made up your mind about how you’ll vote in November, the analyses presented by two top political consultants at the “Health Care and Elections 2004” session might help you weigh each candidate’s messages before you cast your vote.

In his introductory remarks, Dr. John Schaeffer, co-chair of the ACC Advocacy Committee, said that it was important for physicians to pay attention to election messages and to stay politically informed and active to identify those candidates, political action committees, and issues that can help achieve “our needs as cardiovascular physicians.”

Political strategist Ed Goeas of The Tarrance Group, a national Republican polling firm, addressed the well-attended session first and described the trends apparent in most elections and those unique to this presidential campaign. He referenced the “49 percent nation,” a phrase coined by a USA Today reporter to describe the persistent trend over the last 16 years to elect a president without a majority vote. “Ticketsplitters are half [the number] they were a few years ago,” he said.

Political strategist Celinda Lake, of Lake, Snell, Perry & Associates, presented the Democratic counterpart to Mr. Goeas’ remarks and forecast that voter turnout would be key to either candidate’s success. As a demographic, unmarried women in particular, have huge potential to make a difference in the election, she said. Mr. Goeas identified the dominant issues of the 2004 campaign as Medicare, health care, education, taxes, and moral issues. And he forecast that the major party candidates wouldn’t pick just one or two issues to discuss, but that all the issues would predominate the campaign. Within the next two weeks, the Republican party will release campaign messages via “a $10 million TV buy,” he said.

The two partisan experts agreed that health care issues were high-ranking concerns among all Americans, behind top-tier issues such as the war in Iraq, the war on terrorism, the national economy, and job growth, running nose to nose with education as “upper second tier” issues. Ms. Lake said that according to poll information, voters focus on health care access, quality, and choice. She said that, overwhelmingly, voters are concerned about health care costs and tend to view the issue as part of a major economic problem.

The rising cost of health care coverage for small businesses, according to Lake, is “one reason there is no [expansion in] jobs creation.” But rising health care costs could make 2004 “the health care election,” she said. Health care is viewed as a personal economic issue, she added. “It’s an issue [of concern] that wins out over taxes.” Both strategists agreed that health care issues are powerful because they provide direct dialog on issues voters care about, they relate to the economy, and they relate to “character dynamics” of both party candidates.

“Health care is a good illustration,” Lake said, of how candidates have formed relationships with industry, accepting large campaign donations from the pharma or care management industry, for instance. “Halliburton is a household word now,” she quipped.

Top-ranking health care issues, according to polling information, Lake said, are lowering the costs of prescription drugs, lowering the costs of health care insurance, and protecting the uninsured. She agreed with her Republican colleague that, “medical liability is beginning to be seen by voters as a key cost to them personally.” But, she added, “they tend not to think cost rests here, but with profits earned by health care management companies.”

Celinda Lake forecast that campaign messages, federally and in state races, would focus on anticorporate populism, the uninsured, and patriotism. She specified that congressional candidates and other state candidates might run on initiatives related to the correction of problems encountered at nursing homes, i.e. high costs, resident abuse, and neglect.

“Voters believe that health care is a right, not a privilege,” said Ed Goeas, reinforcing the fact that voters tend to believe that “unfair profits” are gained from costs they underwrite.

Because one-fourth of the electorate now pay for their own health care coverage, said Lake, the biggest difference in this election is that more Americans are more aware of health care costs than during any past election.

Young Investigator Awards Announced at Convocation
 The winners of the 2004 Young Investigators Awards were announced at the College’s 53rd Annual Convocation Ceremony on Tuesday evening.

Clinical Investigations—Cardiology and Cardiovascular Surgery
First Place: William S. Kerwin, PhD, University of Washington, Seattle
Second Place: Robert Wolk, MD, Mayo Clinic, Rochester, Minn.
Honorable Mention: Charalambos Antoniades, MD, Hippokration Hospital, Athens, Greece; Elizabeth Fortescue, MD, Children's Hospital, Boston; Oussama Wazni, MD, The Cleveland Clinic

Physiology, Pharmacology, and Pathology
First Place: Saumya Sharma, MD, University of Texas Houston Medical Center
Second Place: Young-Sup Yoon, MD, St. Elizabeth's Medical Center, Boston
Honorable Mention: Takayasu Arai, MD, Stanford University Medical Center, California; Andrew Maree, MD, The Royal College of Surgeons in Ireland; Yoshiyuki Rikitake, MD, Brigham & Women's Hospital, Boston

Molecular and Cellular Cardiology
First Place: Subodh Verma, MD, University of Toronto, Canada
Second Place: Angela Taylor, MD, University of Virginia, Charlottesville
Honorable Mention: Alok S. Pachori, PhD, Harvard Medical Center, Boston; Yao Liang Tang, MD, University of Florida, St. Petersburg; Yasuhiko Sakata, Brigham & Women's Hospital, Boston.

Health Policy Symposium Sheds Light On Off-Label Use
 When a physician decides to use a drug or device for off-label purposes, the burden of responsibility for that action falls on the physician’s shoulders. Tuesday’s Health Policy Symposium educated attendees on how various government agencies view off-label situations.

“The mission of the ACC is to advocate for quality cardiovascular care through education, research promotion, development and application of guidelines, and through influencing health care policy,” said moderator Janet Wright, MD. “The practice of medicine requires physicians to act in the best interest of our patients. If physicians use a product for an indication not approved in the labeling, it’s our obligation to be well informed about that product, and to base our decisions on sound medical evidence and scientific rationale.”

The problem of off-label usage begins with the very definition itself.

“For devices, it is sometimes difficult to perceive differences between ‘labeled use’ and ‘use included but not named,’” said Deborah Wolf, regulatory counsel with the FDA’s Office of Compliance. “Intended use reflects the company’s intent for the specific use of a device.”

Ms. Wolf directed physicians to a new FDA Web page that contains information on approved products for prevention, diagnosis, and treatment of heart conditions: www.fda.gov/hearthealth. It includes full descriptions and patient instructions for many medications, medical devices, and diagnostic tests for cardiovascular disease.

Off-label uses sometimes arise from the restrictive nature of the clinical trials.

Ashley Boam, MSBE, chief of the FDA’s Interventional Cardiology Devices Branch in the Division of Cardiovascular Devices, called on physicians to construct research trials that better reflect diversity.

“Our typical clinical trials have pretty vanilla patient populations,” she said. “I encourage you to work with the agency to come up with creative clinical trial designs that address the complexities of the nonvanilla, real-world population.”

When it comes to off-label coverage, the Centers for Medicare and Medicaid Services generally leaves that decision to its local contractors, said Steve Phurrough, MD, director of the centers’ Coverage and Analysis Group.

“I want to dispel a rumor I’ve heard lately: The CMS is not currently planning any national policy to broadly noncover all offlabel indications for devices,” he said. “When coverage decisions are made, our decisions are not brand-specific, but they will specify that whatever is used has to be FDA-approved”

The FTC has it easy compared to the FDA, joked Matthew Daynard, senior attorney in the FTC’s Division of Advertising Practices.

“Whether it’s intended use or off-label use, it’s all the same to us. We care whether or not its claims are true,” Mr. Daynard said. He pointed out that the FDA has primary jurisdiction for the labeling of devices, OTC, and all prescription drug ads, while the FTC has primary jurisdiction for the advertising of devices, services, and OTC drugs.

“We don’t pre-approve ads, so before you send your ad out, be sure it’s accurate, because you can’t say once it’s in print, ‘oh, I didn’t mean it.’”

Distinguished Awardees Honored at Convocation
 The following cardiovascular specialists were recognized for their outstanding achievements at the 53rd annual Convocation on Tuesday evening.

Raymond J. Gibbons, MD, of Rochester, Minn., received the Distinguished Fellowship Award. Dr. Gibbons has held numerous important College positions, including key posts chairing the Cardiovascular Imaging Committee, the Task Force on Practice Guidelines, the Committee to Revise the Exercise Testing Guidelines, and the Committee to Write Guidelines for the Management of Stable Angina. His contributions as a clinical investigator have been widely acclaimed in the field of cardiovascular imaging.

Francois M. Abboud, MD, of Iowa City, Iowa, received the Distinguished Scientist Award (Basic Domain). Under his leadership, the University of Iowa Cardiovascular Research Center has become one of the most prestigious cardiovascular training centers in the world. Through his discovery of evolutionary conserved mechanosensitive molecules and his work on the effects of gene transfer and transgenic mutations on the baroreflex mechanism, he has contributed basic scientific discoveries with enormous potential for effectively battling cardiovascular disease.

Robert M. Califf, MD, of Durham, N.C., received the Distinguished Scientist Award (Clinical Research). One of the pioneers of the Duke Database for Cardiovascular Disease, Dr. Califf significantly contributed to the creation of an observational database at the foundation of what is now known as the Duke Clinical Research Institute. Dr. Califf also has served as a key advisor to the National Institutes of Health and the U.S. Food and Drug Administration, and has aided public-private partnerships in gaining a better understanding of cardiovascular therapeutics.

George A. Diamond, MD, of Los Angeles, received the Distinguished Service Award. Among Dr. Diamond’s most profound contributions to health care delivery is his work in the area of Bayesian analysis and its application to diagnostic testing. His seminal work in the clinical diagnosis of coronary artery disease advanced the concept that a test’s diagnostic accuracy depended on the prevalence of disease conditions. Subsequently, this concept was incorporated into general health care diagnostic testing far beyond the confines of cardiovascular medicine.

Joseph S. Alpert, MD, of Tucson, Ariz., received the Gifted Teacher Award. As head of the Department of Medicine at the University of Arizona Health Sciences Center and a professor of medicine, Dr. Alpert has mentored and supervised many fellows in cardiology at home and abroad. Many of his fellows have distinguished themselves as directors or chairs of Divisions of Cardiology. He continues setting teaching standards as a member of the ACC Publications Committee and the ACC/AHA Consensus Conference on Ethics.

Keyur H. Parikh, MD, of Ahmedabad, India, received the International Service Award. Born of Indian heritage in East Africa, Dr. Parikh set his sights on becoming a physician so that he could take his skills to India where they might benefit those most in need. His journeyed to the United States, where he acquired his continuing cardiovascular education. After establishing a successful cardiology practice in the San Francisco Bay area, he uprooted himself mid-career to move to Ahmedabad, a city bereft of any cardiology programs. There, he funded a catheterization laboratory and established a hospital with sophisticated cardiology programs. He has lectured and conducted training courses throughout India and distinguished himself as a philanthropic health care leader in the aftermath of India’s recent natural disasters.

Costas T. Lambrew, MD, of Scarborough, Maine, received the designation of Master of the American College of Cardiology in recognition of his long and distinguished career in cardiology and as an ACC Fellow. A former Trustee, Dr. Lambrew served on the ACC /AHA Task Force on Performance Measures and the subsequent writing groups for acute myocardial infarction and congestive heart failure. He championed the concept of the cardiac care team until 2003, when the ACC Board approved ACC membership for qualified nurses and physician assistants.

William C. Roberts, MD, of West Haven, Conn., received the designation of Master of the American College of Cardiology. Known as an extraordinary pathologist and clinical educator, Dr. Roberts has made extensive contributions to the ACC and other leading cardiovascular institutions. He is a leading advocate of aggressive measures to slow the atherosclerotic process.

David J. Sahn, MD, of Portland, Ore., received the designation of Master of the American College of Cardiology. A longserving Fellow, educator, and thought leader, Dr. Sahn is best known for advancing collaboration between adult and pediatric cardiovascular specialists and working at the frontiers of physics and engineering to advance diagnostic imaging.

Samuel L. Wann, MD, of Milwaukee, Wisc., received the designation of Master of the American College of Cardiology. In addition to his clinical and academic achievements, Dr. Wann founded the Foundation for International Medical Exchange to improve cardiac care abroad. His leadership in advocacy has increased visibility of key issues and the need for long-term strategies. He also has served as a volunteer in the care of uninsured patients.

Experts Explore New Developments in Nuclear Cardiology
 Nuclear cardiology is a rapidly evolving field that has an important impact on the evaluation and management of patients with cardiac disease. During a session on “Evolving Concepts in Nuclear Cardiology,” experts described two of the latest developments in nuclear cardiology —meta-iodobenzyl guandine I (MIBG) imaging and the use of betamethyliodophenyl- pentadecanoic acid (BMIPP) to image ischemic memory.

Steven R. Bergmann, MD, from Beth Israel Medical Center in New York, described a multicenter study of the use of 123I-BMIPP to image ischemic memory in the myocardium of 32 patients being evaluated for chest pain. The patients underwent a Thallium stress test and then rest BMIPP imaging studies.

BMIPP uptake occurs in the fatty acids metabolic pathway and the uptake increases over time. “During ischemia, fatty acid metabolism changes,” Dr. Bergmann said. “Alterations in fatty acid metabolism persist after ischemia is resolved. BMIPP imaging of fatty acid pathways can identify antecedent, resolved ischemia. However, additional studies are clearly needed.”

Myron C. Gerson, MD, from Cincinnati, said:

  • It may have a role as a memory tracer for ischemia.
  • It may predict sudden cardiac death and the need for an implantable defibrillator.
  • It has potential for clarifying some of the mechanisms of heart failure progression.
  • It is a powerful prognosticator for heart failure patients with dilated cardiomyopathy.

“In addition, I think MIBG is important because it offers us the opportunity to have the 123I tracer available for the future,” Dr. Gerson said. “The future of nuclear cardiology may well be molecular cardiology. The 123I tracer can readily label small molecules.”

He suggested that a rest injection of BMIPP given in an emergency room followed by imaging later on might identify antecedent ischemia. “This imaging study is quite promising and something we should explore further.”

“So, is MIBG imaging ready for clinical use?” Dr. Gerson asked. “It’s not ready from a practical standpoint,” but it should continue to be developed for future use. Currently, MIBG is not readily available; its cost is high and not reimbursed by insurance carriers; and large clinical trials on its value in cardiac imaging have not been conducted yet.

Slate of Officers and Trustees Announced
 Election of the 2004-05 officers and Board of Trustees was held during the Annual Business Meeting on Monday.

  • Michael J. Wolk, MD, automatically assumed the office of president at last night’s Convocation.
  • Pamela S. Douglas, MD, of Madison, Wisc., became presidentelect, and Steven E. Nissen, MD, of Cleveland, became vice president.

The following members were approved as trustees and began their five-year terms (2004–09):

  • Michael D. Freed, MD;
  • David R. Holmes, Jr., MD;
  • Michael J. Mirro, MD; and
  • Miguel A. Quiñones, MD.

ACCF Cosponsors Intervention2004™
 The ACC Foundation has announced its cosponsorship of Intervention2004 scheduled for June 3–5, 2004, in Atlanta; Boston; Cleveland; Minneapolis, Minn.; and San Jose, Calif. The College is partnering with Moceri Management to present the premier interventional cardiology educational symposium for cardiac care team members.

The symposium, designed for cardiovascular practice directors, partners, and senior cardiologists interested in coronary and peripheral intervention, thrombosis, angiogenesis, and imaging, will provide tools and experience to support growth and mastery as cardiovascular care providers.

Leading physicians from across the United States will link together via satellite to share live case presentation discussions, lectures and debates, and interactive point-counterpoint analysis on the latest research and practice trends from regionally convenient locations.

This program is supported by educational grants from various U.S. hospitals and commercial organizations. For a complete list of supporters, or to register, visit www.InterventionSymposium.com.