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The mission of the American Heart Association is to be a relentless force for a world of longer, healthier lives. The American Heart Association has consistently prioritized the needs and perspective of the patient in taking positions on healthcare reform while recognizing the importance of biomedical research, providers, and healthcare delivery systems in advancing the care of patients and the prevention of disease. The American Heart Association’s vision for healthcare reform describes the foundational changes needed for the health system to serve the best interests of patients and to achieve health care and coverage that are adequate, accessible, and affordable for everyone living in the United States. The American Heart Association is committed to advancing the dialogue around healthcare reform and has prepared this updated statement of our principles, placed in the context of the advances in coverage and care that have occurred after the passage of the Affordable Care Act, the rapidly changing landscape of healthcare delivery systems, and our evolving recognition that efforts to prevent cardiovascular disease can have synergistic benefit in preventing other diseases and improving overall well-being. These updated principles focus on expanding access to affordable health care and coverage; enhancing the availability of evidence-based preventive services; eliminating disparities that limit the availability and equitable delivery of health care; strengthening the public health infrastructure to respond to social determinants of health; prioritizing and accelerating investments in biomedical research; and growing a diverse, culturally competent health and healthcare workforce prepared to meet the challenges of delivering high-value health care.

The healthcare system is undergoing a transition from paying for volume to paying for value. Clinicians, as well as public and private payers, are beginning to implement alternative delivery and payment models, such as the patient-centered medical home, accountable care organizations, and bundled payment arrangements. Implementation of these new models will necessitate delivery system transformation and will actively involve all fields of medical care, in particular medicine and surgery. This call to action, on behalf of the American Heart Association’s Expert Panel on Payment and Delivery System Reform, serves to offer support and direction for further involvement by the American Heart Association. In doing so, it (1) provides baseline review and definition of the present models and some of the early results of these delivery models, including outcomes; (2) initiates a conversation within the American Heart Association on the impact of payment and delivery system reform, as well as how the American Heart Association should engage in the interest of patients; (3) issues a call to action to our organization and to cardiovascular and stroke health professionals across the country to become educated about these models so to as to understand their impact on patient care; and (4) asks the government and other funding agencies, including the American Heart Association, to begin supporting and prioritizing meaningful research endeavors to further evaluate these models.

In 2007, the Society for Cardiovascular Angiography and Interventions (SCAI) published an Expert Consensus Document titled “The Current Status and Future Direction of Percutaneous Coronary Intervention without On-Site Surgical Backup.”1 This document summarized the available data on the performance of percutaneous coronary intervention (PCI) without on-site surgery in the United States (US), reviewed the existing literature, examined the recommendations for the performance of PCI in this setting from several professional organizations abroad and from experienced programs in the US, defined the best practices for facilities engaged in PCI without on-site surgery and made recommendations for the future role of PCI without on-site surgery. Since publication of that document, new studies, meta-analyses, and randomized trials have been published comparing PCI with and without on-site surgery. In addition, the total number of PCIs performed annually has decreased, reports about the overuse of PCI have emerged, and appropriate use criteria for coronary revascularization have been published. A noteworthy change occurred in the 2011 PCI guideline in which elective PCI was upgraded to Class IIb and primary PCI was upgraded to Class IIa at facilities without on-site surgery.2 Several tables on the structure and operation of programs without on-site surgery from the 2007 SCAI Expert Consensus Document were used in the 2011 PCI guideline recommendations. Finally, new updates of the ACCF/SCAI Expert Consensus Document on Cardiac Catheterization Laboratory Standards and the ACCF/AHA/SCAI Clinical Competence in Coronary Artery Interventional Procedures have been published.3,4 Although many of the concerns about the safety of PCI without on-site surgery have been resolved, there are new issues to consider as the delivery of PCI continues to evolve in the US. Accordingly, the SCAI, ACCF, and AHA have engaged in this effort to reevaluate the current status of PCI without on-site surgery in the US. …

The complexity and global scope of cardiovascular disease have reached unparalleled heights. No sooner do we achieve success in treating and managing some forms of cardiovascular disease than new ones such as metabolic stress-induced pathologic remodeling emerge with alarming incidence and severity. To address these evolving challenges head on, a multidisciplinary strategy is required. Physicians and surgeons, scientists, advanced practice providers, nurses, and pharmacists are working together around the world to prevent disease or, when present, to slow, halt, and even reverse its progression. It is the aspiration, indeed firm commitment, of the Circulation editorial team to foster this progress across the full spectrum of cardiovascular professional activities. We will work hard to …

The mission of the American Heart Association/American Stroke Association includes increasing access to high-quality, evidence-based care that improves patient outcomes such as health-related quality of life and is consistent with the patients’ values, preferences, and goals. Awareness of and access to palliative care interventions align with the American Heart Association/American Stroke Association mission. The purposes of this policy statement are to provide background on the importance of palliative care as it pertains to patients with advanced cardiovascular disease and stroke and their families and to make recommendations for policy decisions. Palliative care, defined as patient- and family-centered care that optimizes health-related quality of life by anticipating, preventing, and treating suffering, should be integrated into the care of all patients with advanced cardiovascular disease and stroke early in the disease trajectory. Palliative care focuses on communication, shared decision making about treatment options, advance care planning, and attention to physical, emotional, spiritual, and psychological distress with inclusion of the patient’s family and care system. Our policy recommendations address the following: reimbursement for comprehensive delivery of palliative care services for patients with advanced cardiovascular disease and stroke; strong payer-provider relationships that involve data sharing to identify patients in need of palliative care, identification of better care and payment models, and establishment of quality standards and outcome measurements; healthcare system policies for the provision of comprehensive palliative care services during hospitalization, including goals of care, treatment decisions, needs of family caregivers, and transition to other care settings; and health professional education in palliative care as part of licensure requirements.

In this review, we will attempt to envision not just emerging changes in training in each of our specialties, but also some of the general directions in which the field of postgraduate medical education will evolve. Although the formal training programs in our professional areas are at distinctive phases in the transition from a traditional time-limited apprenticeship model to one that is focused on the quantitative assessment of competency, they each share the burdens of adapting to increasingly rapid change in the fundamental knowledge base and in patterns of care delivery. These challenges come at a time when there is increasing uncertainty in reimbursement and job security for clinicians in cardiovascular disease. We have tried to highlight specific developments in the relevant sections, but it is clear that the external and internal pressures in each cardiovascular specialty and our responses to these pressures overlap considerably. By learning from each other and adopting best practices, we will be better able to cope with the inevitable change that professional education promises in the next decade and beyond. The education and training of physicians in pediatric cardiology continues to evolve with a recent paradigm shift in training from proscriptive time-based or procedural number-based recommendations for training to competency-based objectives. The 2015 training guidelines for Pediatric Cardiology programs were revised by task force members that included representatives from all relevant professional societies (American Academy of Pediatrics, American College of Cardiology, and American Heart Association) and the Society of Pediatric Cardiology Training Program Directors.1 The 2015 guidelines highlight the paradigm shift toward competency. Although previous guidelines were based on the assumption that competency for given activities, tasks, or procedures would naturally follow from proscriptions of months of exposure and numeric targets, the new guidelines reflect the reality that it is competence that is the …

Influencing public policy through advocacy is an essential strategy used by the American Heart Association/American Stroke Association (AHA/ASA) to achieve its health impact goals and programmatic objectives, which include helping all Americans lead healthier lives and reducing the incidence and consequences of cardiovascular disease and stroke. This advocacy work involves and engages the association's national officers, researchers, volunteer advocates, staff, and the general public and is a core strategy and key work process of the AHA/ASA. The organization's strategic approach to influencing public policy and leveraging its science and evidence base is not well known. This article provides the historical context of AHA advocacy, the organizational and legal structure under which these activities are carried out, the process used to develop the association's public policy positions and goals, the approaches used to achieve these goals, and the methods that have been developed to evaluate progress. This statement also examines the various tools and tactics that advocacy organizations use to influence public policy and specifically how the AHA/ASA conducts policy research, legislative and regulatory lobbying, coalition building and grassroots mobilization, and media advocacy. Finally, the ways that AHA/ASA evaluates the impact of its advocacy efforts are discussed, highlighting specific case studies and a brief summary of the association's 2010 to 2013 public policy agenda. The AHA's efforts to translate the science of cardiovascular disease and stroke into meaningful public policy began in earnest in the early 1980s. The association established a full-time office in Washington, DC, in early 1981 that was initially focused on increasing federal research funding administered by the National Institutes of Health.1 Other early policy priorities included tobacco control and support for programs that increased access to automated external defibrillators (AEDs), new clinical preventive benefits in the Medicare program, and nutrition policy. The commitment and involvement of …

This expert consensus document was developed by the American College of Cardiology Foundation (ACCF), the American College of Gastroenterology (ACG), and the American Heart Association (AHA). Expert consensus documents inform practitioners, payers, and other interested parties of the opinion of ACCF and document cosponsors concerning evolving areas of clinical practice or medical technologies. Expert consensus documents cover topics for which the evidence base, experience with technology, or clinical practice is not considered sufficiently well developed to be evaluated by the formal ACCF/AHA Practice Guidelines process. Often, the topic is the subject of considerable ongoing investigation. Thus, the reader should view the expert consensus document as the best attempt of the ACCF and document cosponsors to inform clinical practice in areas where rigorous evidence may not yet be available. To avoid actual, potential, or perceived conflicts of interest that may arise as a result of industry relationships or personal interests among the writing committee, all members of the writing committee, as well as peer reviewers of the document, are asked to disclose all current healthcare-related relationships and those existing 12 months before initiation of the writing effort. The ACCF Task Force on Clinical Expert Consensus Documents (CECD) reviews these disclosures to determine which companies make products (on market or in development) that pertain to the document under development. Based on this information, a writing committee is formed to include a majority of members with no relevant relationships with industry (RWI), led by a chair with no relevant RWI. Authors with relevant RWI are not permitted to draft or vote on text or recommendations pertaining to their RWI. RWI are reviewed on all conference calls and updated as changes occur. Author and peer reviewer RWI pertinent to this document are disclosed in Appendixes 1 and 2, respectively. Additionally, to ensure complete transparency, …

Determining the comparative effectiveness of different treatment modalities provides a potentially useful approach for improving clinical decision making and patient outcomes. There are, however, differing views of the definition, scope, and application of comparative effectiveness research that have led to considerable controversy. As a mission-driven volunteer organization that focuses on optimal cardiovascular health for all Americans and on the best interests of patients with cardiovascular diseases and stroke, the American Heart Association offers the following principles on comparative effectiveness research.

This week, thousands of healthcare providers and scientists from throughout North America and from >70 countries have come to this conference. We are here in New Orleans, a city that was devastated by Hurricane Katrina in 2005. This community is still recovering and rebuilding. By attending this meeting, we are providing support for the people of New Orleans and helping the city flourish again. We are also here today at an exciting moment of transformation in the United States. Just 5 days ago, we elected a new president, and our nation’s mood is one of hope and expectation. Many believe that this change in our nation’s leadership marks a new era of opportunity. Like New Orleans, the United States was stricken by an almost unfathomable assault and disaster early in this new century. Our nation has struggled to understand that disaster. Some of our responses have been unsettling, both to us and to many of our friends. But we are now looking to the future with new confidence. In this moment of opportunity and renewed hope, let us remind ourselves that all of us here today, as well as our colleagues in the healthcare professions, are de facto leaders in our communities by virtue of our education and our professional responsibilities for others. In addition to our individual roles in clinical medicine, research, and many related fields, we are also citizen leaders in our societies. “To whom much is given, much is required” certainly applies to us. And this is what I would like to talk to you about today. I want us to acknowledge our shared mission as citizen leaders and challenge ourselves to consider the implications of this rallying cry, which is just a nuance away from the American Heart Association’s newly defined mission statement: “Building healthier lives, …

The report by Culler and associates1 in this issue of Circulation provides useful information about the trends and outcomes of coronary revascularization procedures currently being performed in the United States. Data acquisition for this analysis of coronary revascularization activity from 2008 through 2012 required tedious mining of 2 complex data sets maintained by the Centers for Medicare and Medicaid Services. In addition to the Medicare Provider Analysis and Review file, which contains all inpatient claims for Medicare beneficiaries, they reviewed the Medicare Outpatient File, which contains claims for “nonadmission” services, specifically data on outpatient procedures. This latter review was necessary because many percutaneous coronary interventions (PCIs) are now done in acute hospital settings but with patients classified as outpatients or hospitalized but under observation status. An obvious limitation of this report of current revascularization trends is the fact that only Medicare patient data were analyzed. Coronary revascularizations of Medicare beneficiaries, however, are believed to represent a modest majority of such procedures and to reliably reflect total revascularization activity in the United States. Article see p 362 This report presents an exhaustive review of all revascularizations performed on Medicare beneficiaries who underwent either PCI or coronary artery bypass grafting (CABG) during the 5-year study period. It is unclear why the authors refer to primary and secondary PCI and CABG. This distinction appears to be meaningless for PCI patients. In addition, they report 90-day postdischarge mortality rates but do not describe how this late postdischarge mortality information was obtained and validated. The principal value of the report is the patient volume information and the analysis of total coronary revascularization procedures done during the recent 5-year period, along with likely accurate early postprocedure mortality data on all Medicare program patients having PCI or CABG surgery during this time. Analysis of the PCI …

One of the most hotly debated and polarizing issues in cardiac surgery has been whether coronary artery bypass grafting (CABG) without the use of cardiopulmonary bypass or cardioplegia (off-pump CABG, or OPCAB) is superior to that performed with the heart-lung machine and the heart's being chemically arrested (standard CABG). Various clinical trials are reviewed comparing the 2 surgical strategies, including several large retrospective analyses, meta-analyses, and the randomized trials that address different aspects of standard CABG and OPCAB. Although definitive conclusions about the relative merits of standard CABG and OPCAB are difficult to reach from these varied randomized and nonrandomized studies, several generalizations may be possible. Patients may achieve an excellent outcome with either type of procedure, and individuals' outcomes likely depend more on factors other than whether they underwent standard CABG or OPCAB. Nevertheless, there appear to be trends in most studies. These trends include less blood loss and need for transfusion after OPCAB, less myocardial enzyme release after OPCAB up to 24 hours, less early neurocognitive dysfunction after OPCAB, and less renal insufficiency after OPCAB. Fewer grafts tend to be performed with OPCAB than with standard CABG. Length of hospital stay, mortality rate, and long-term neurological function and cardiac outcome appear to be similar in the 2 groups. To definitively answer the remaining questions of whether either strategy is superior and in which patients, a large-scale prospective randomized trial is required. (Circulation. 2005;111:2858-2864.)

The past year in cardiac surgery has been particularly fertile from an academic point of view, with the results of 2 large clinical trials (NOBLE [Nordic-Baltic-British Left Main Revascularisation Study] and EXCEL [Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization]) providing additional information about percutaneous coronary intervention versus bypass surgery for the treatment of left main …

The American College of Cardiology/American Heart Association (ACC/AHA) Task Force on Practice Guidelines was formed to gather information and make recommendations about appropriate use of technology for the diagnosis and treatment of patients with cardiovascular disease. Percutaneous coronary

The American College of Cardiology (ACC)/American Heart Association (AHA) Task Force on Practice Guidelines was formed to make recommendations regarding the diagnosis and treatment of patients with known or suspected cardiovascular disease. Coronary artery disease (CAD) is the leading cause of death in the United States. Unstable angina (UA) and the closely related condition non–ST-segment elevation myocardial infarction (NSTEMI) are very common manifestations of this disease. These life-threatening disorders are a major cause of emergency medical care and hospitalizations in the United States. In 1996, the National Center for Health Statistics reported 1 433 000 hospitalizations for UA or NSTEMI. In recognition of the importance of the management of this common entity and of the rapid advances in the management of this condition, the need to revise guidelines published by the Agency for Health Care Policy and Research (AHCPR) and the National Heart, Lung and Blood Institute in 1994 was evident. This Task Force therefore formed the current committee to develop guidelines for the management of UA and NSTEMI. The present guidelines supersede the 1994 guidelines. The customary ACC/AHA classifications I, II, and III summarize both the evidence and expert opinion and provide final recommendations for both patient evaluation and therapy: Class I: Conditions for which there is evidence and/or general agreement that a given procedure or treatment is useful and effective . Class II: Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a procedure or treatment. Class IIa: Weight of evidence/opinion is in favor of usefulness/efficacy. Class IIb: Usefulness/efficacy is less well established by evidence/opinion. Class III: Conditions for which there is evidence and/or general agreement that the procedure/treatment is not useful/effective and in some cases may be harmful. The weight of the evidence was ranked highest (A) if the data …

The American College of Cardiology/American Heart Association (ACC/AHA) Task Force on Practice Guidelines was formed to make recommendations regarding the appropriate use of diagnostic tests and therapies for patients with known or suspected cardiovascular disease. Coronary artery bypass graft (CABG) surgery is among the most common operations performed in the world and accounts for more resources expended in cardiovascular medicine than any other single procedure. Since the original Guidelines were published in 1991, there has been considerable evolution in the surgical approach to coronary disease, and at the same time there have been advances in preventive, medical, and percutaneous catheter approaches to therapy. These revised guidelines are based on a computerized search of the English literature since 1989, a manual search of final articles, and expert opinion. As with other ACC/AHA guidelines, this document uses ACC/AHA classifications I, II, and III as summarized below: Class I: Conditions for which there is evidence and/or general agreement that a given procedure or treatment is useful and effective. Class II: Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness or efficacy of a procedure. Class IIa: Weight of evidence/opinion is in favor of usefulness/efficacy. Class IIb: Usefulness/efficacy is less well established by evidence/opinion. Class III: Conditions for which there is evidence and/or general agreement that the procedure/treatment is not useful/effective and in some cases may be harmful. ### A. Hospital Outcomes Seven core variables (priority of operation, age, prior heart surgery, sex, left ventricular [LV] ejection fraction [EF], percent stenosis of the left main coronary artery, and number of major coronary arteries with significant stenoses) are the most consistent predictors of mortality after coronary artery surgery. The greatest risk is correlated with the urgency of operation, advanced age, and 1 or more prior coronary bypass surgeries. Additional variables that are related …

Preoperative anemia in a patient requiring cardiac surgery generally is not considered an independent risk factor for an unfavorable outcome. Older and sicker patients, especially women, are more likely to be anemic, but these patients often are at higher risk because of other coexisting comorbidities. It is these other comorbidities and risk factors that are accounted for in most risk-prediction models of patients undergoing heart surgery. The present report by Kulier et al1 demonstrates that anemia itself is a risk factor and that the degree of risk is proportional to the level of anemia. This finding, however, uncovers a common dilemma in the management of cardiac surgery patients. The controversy revolves around whether and even how best to deal with the anemia that is encountered in most cardiac surgery patients before, during, and after the surgery. This “transfusion” dilemma is a result of many equally compelling reports on the detrimental effects of blood transfusions in critically ill postoperative patients, including specific reports in cardiac surgery populations. Article p 471 It is well recognized that moderate to severe preoperative anemia, with hemoglobin (Hb) levels of 10 g/dL or less, can complicate what would otherwise be a straightforward cardiac operation. The hemodilution that occurs as a result of the pump priming volume required to establish cardiopulmonary bypass may not be tolerated by anemic patients without the addition of red blood cells (RBCs) to the prime or to the pump circuit once bypass has begun. In addition, tolerable levels of anemia in the perioperative and early postoperative phase for younger cardiac surgery patients may not be tolerated in older patients who are prone to excessive vasodilation and inadequate cerebral or renal perfusion in the perioperative period without RBC transfusion and better oxygen-delivery capacity. Overshadowing these considerations has been the suggestion by some …

Virtually all cardiac surgeons and their referring cardiologists know that the most effective and reliable coronary artery bypass conduit is the pedicled internal thoracic (mammary) artery (LITA) when placed to the left anterior descending artery coronary artery (LAD). This first choice of bypass graft conduits is based on convincing evidence of improved survival in patients with critical LAD disease in whom an LITA graft has been placed.1,2 The importance of an LITA graft when bypassing the LAD is so well accepted that it is now used as a quality indicator in the assessment of the performance of cardiac surgery programs in coronary artery bypass graft surgery (CABG).3 Article p 684 Unfortunately, how best to construct bypass grafts to other diseased coronary arteries in CABG patients, the vast majority of whom have multivessel disease and require several grafts, is not nearly as clearly understood. What is known is that the widely used saphenous vein graft has a significant and progressive failure rate; the probability of having a well-functioning vein graft 10 years after CABG is ≈60%.4 Because the remarkably durable LITA graft is so reliable and the saphenous vein graft so prone to progressive atherosclerosis-like deterioration, it has been most surgeons’ hope that “arterial” conduits might be the answer to improving graft durability and the effectiveness of CABG surgery. The Radial Artery Patency Study (RAPS) Investigators, surgeons from 12 Canadian hospitals and 1 New Zealand hospital, have addressed the question of whether an arterial graft, in this case the radial artery, will outperform the saphenous vein as a bypass conduit. In a previous report on this same well-designed randomized trial, Desai and colleagues5 demonstrated that radial artery grafts have lower rates of angiographically defined graft occlusion at a 1-year follow-up compared with saphenous vein grafts. In the …

This executive summary and recommendations appears in the November 3, 1998, issue of Circulation . The guidelines in their entirety, including the ACC/AHA Class I, II, and III recommendations, are published in the November 1, 1998, issue of the Journal of the American College of Cardiology . Reprints of both the full text and the executive summary and recommendations are available from both organizations. During the past 2 decades, major advances have occurred in diagnostic techniques, the understanding of natural history, and interventional cardiological and surgical procedures for patients with valvular heart disease. The information base from which to make clinical management decisions has greatly expanded in recent years, yet in many situations, management issues remain controversial or uncertain. Unlike many other forms of cardiovascular disease, there is a scarcity of large-scale multicenter trials addressing the diagnosis and treatment of valvular disease from which to derive definitive conclusions, and the literature represents primarily the experiences reported by single institutions in relatively small numbers of patients. The Committee on Management of Patients With Valvular Disease was given the task of reviewing and compiling this information base and making recommendations for diagnostic testing, treatment, and physical activity. These guidelines follow the format established in previous American College of Cardiology/American Heart Association (ACC/AHA) guidelines for classifying indications for diagnostic and therapeutic procedures: Class I: Conditions for which there is evidence and/or general agreement that a given procedure or treatment is useful and effective Class II: Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a procedure or treatment IIa. Weight of evidence/opinion is in favor of usefulness/efficacy IIb. Usefulness/efficacy is less well established by evidence/opinion. Class III: Conditions for which there is evidence and/or general agreement that the procedure/treatment is not useful and in some cases …

Background The relationship among the maternal, placental, and uniquely shunted embryonic circulation was explored to provide access to the embryonic cardiovascular system in utero. Manipulation of gene expression in the developing heart would be particularly useful for studying the effects of altered gene expression on cardiac development and in the etiology of congenital cardiac anomalies. Methods and Results Dye studies demonstrated that intraplacental injection allows direct access to the embryonic cardiac and systemic circulation. To evaluate the efficacy of cardiac gene transfer using this approach, replication-deficient recombinant adenoviral vectors encoding luciferase or β-galactosidase as reporter genes were injected intraplacentally into embryonic day (E)12.5 murine embryos, an age at which the mass of the heart was observed to be large compared with other organs. Embryos were assayed for transgene expression at E15.5 and at birth. Survival rates at these times were similar among vector-injected and control groups. At E15.5 and at birth, luciferase activity within the heart was 9- and 23-fold higher, respectively, than in the remainder of the embryo, although levels of expression were generally lower at birth than during embryonic life. β-Galactosidase expression was observed within all regions of the embryonic heart and was localized to ≈15% of atrial and ventricular cells. Conclusions Intraplacental delivery of adenovirus at embryonic day 12.5 results in somatic gene transfer to the murine embryonic heart, which persists at least until birth. The combination of intraplacental injection to directly access the fetal coronary circulation and injection at E12.5 when the mass of the heart is large compared with other organs results in transgene expression in cardiac cells. Intraplacental injections early in embryonic life may thus be useful to study the effects of temporal manipulation of gene expression on cardiac development and disease.

Preamble It is clearly important that the medical profession plays a significant role in critically evaluation of the use of diagnostic procedures and therapies in the management or prevention of disease. Rigorous and expert analysis of the available data documenting relative benefits and risks of those procedures and therapies can produce helpful guidelines that …

Background Cardiomyoplasty (CM) is a novel surgical therapy for dilated cardiomyopathy. In this procedure, the latissimus dorsi muscle is wrapped around the heart and chronically paced synchronously with ventricular systole. While studies have found symptomatic improvement from this therapy, the mechanisms by which CM confers benefit remain uncertain. This study sought to better define these mechanisms by means of serial pressure-volume relation analysis. Methods and Results Serial pressure-volume studies were performed by the conductance catheter method in three patients (total to date) with dilated cardiomyopathy (New York Heart Association class III) who underwent CM. Data were measured at baseline (before surgery) and at 6 and 12 months after CM. Chronic left ventricular (LV) systolic and diastolic changes induced by CM were evaluated with the stimulator in its stable pacing mode (every other beat) and after temporarily suspending pacing. CM-stimulated beats were compared with pacing-off beats to evaluate active systolic assist effects of CM. In each patient, CM resulted in a chronic lowering of cardiac end-diastolic volume and an increased ejection fraction. Most notably, the end-systolic pressure-volume relation shifted leftward, consistent with reversal of chronic chamber remodeling. In contrast, the diastolic pressure-volume relation was minimally altered, and the loops shifted down along the same baseline relation. These marked chronic changes in LV function measurable with CM stimulation off contrasted to only minor acute effects observed when the muscle wrap was activated. This suggests that the benefit of CM derived less from active systolic assist than from remodeling, perhaps because of an external elastic constraint. Conclusions These data, while limited to a small number of patients, suggest that CM can reverse remodeling of the dilated failing heart. While systolic squeezing assist effects of CM may play a role in some patients, our study found that this was not required to achieve substantial benefits from the procedure. We speculate that CM may act more passively, like an elastic girdle around the heart, to help reverse chamber remodeling.

Building healthier lives, free of cardiovascular diseases and stroke” is the mission of the American Heart Association (AHA). The AHA realizes that the current healthcare crisis in the United States threatens this mission. Thus, we have prepared this statement regarding healthcare reform with particular emphasis on cardiovascular diseases and stroke. We intend to promote and actively engage in a dialogue within the country that addresses these critical issues. There is an urgent need to reform our healthcare system to improve the lives of individuals who have (or who are at risk for developing) cardiovascular diseases and stroke. Nearly 15 years have passed since healthcare reform became a prominent national policy issue. In 1993 and 1994, a series of articles appeared in Circulation describing the principles, recommendations and concerns of the AHA regarding healthcare reform.1–6 Tremendous accomplishments have been made over the intervening years in the biological and clinical sciences, resulting in significant improvements in the prevention, diagnosis and treatment of cardiovascular diseases and stroke. Unfortunately, new challenges threaten to reverse these gains, including the aging of the population and unwise lifestyle choices related to smoking, diet and physical activity. Children with congenital heart disease, who formerly would have died, now survive to confront these challenges. Barriers—often arising from the cost of care in the current healthcare system—make the delivery of patient-centered health care increasingly difficult. Many patients cannot readily access high-quality, evidence-based healthcare services, and healthcare providers face similar difficulties when trying to deliver these services. With over 46 million uninsured individuals in the United States and continued increases in the cost of both health insurance and health care, the need for meaningful healthcare reform is much greater today than it was 15 years ago. Unfortunately, the 46 million uninsured individuals include over 8 million children who have limited …

Background—The purpose of this statement is to update the recommendations by the American Heart Association (AHA) for the prevention of infective endocarditis that were last published in 1997.Methods and Results—A writing group was appointed by the AHA for their expertise in prevention and treatment of infective endocarditis, with liaison members representing the American Dental Association, the Infectious Diseases Society of America, and the American Academy of Pediatrics. The writing group reviewed input from national and international experts on infective endocarditis. The recommendations in this document reflect analyses of relevant literature regarding procedure-related bacteremia and infective endocarditis, in vitro susceptibility data of the most common microorganisms that cause infective endocarditis, results of prophylactic studies in animal models of experimental endocarditis, and retrospective and prospective studies of prevention of infective endocarditis. MEDLINE database searches from 1950 to 2006 were done for English-language papers using the following search terms: endocarditis, infective endocarditis, prophylaxis, prevention, antibiotic, antimicrobial, pathogens, organisms, dental, gastrointestinal, genitourinary, streptococcus, enterococcus, staphylococcus, respiratory, dental surgery, pathogenesis, vaccine, immunization, and bacteremia. The reference lists of the identified papers were also searched. We also searched the AHA online library. The American College of Cardiology/AHA classification of recommendations and levels of evidence for practice guidelines were used. The paper was subsequently reviewed by outside experts not affiliated with the writing group and by the AHA Science Advisory and Coordinating Committee.Conclusions—The major changes in the updated recommendations include the following: (1) The Committee concluded that only an extremely small number of cases of infective endocarditis might be prevented by antibiotic prophylaxis for dental procedures even if such prophylactic therapy were 100% effective. (2) Infective endocarditis prophylaxis for dental procedures is reasonable only for patients with underlying cardiac conditions associated with the highest risk of adverse outcome from infective endocarditis. (3) For patients with these underlying cardiac conditions, prophylaxis is reasonable for all dental procedures that involve manipulation of gingival tissue or the periapical region of teeth or perforation of the oral mucosa. (4) Prophylaxis is not recommended based solely on an increased lifetime risk of acquisition of infective endocarditis. (5) Administration of antibiotics solely to prevent endocarditis is not recommended for patients who undergo a genitourinary or gastrointestinal tract procedure. These changes are intended to define more clearly when infective endocarditis prophylaxis is or is not recommended and to provide more uniform and consistent global recommendations.

New surgical procedures, imaging modalities, and medical devices have improved therapy for many patients and made treatment possible for others who have had few options in the past. In February 2004, the National Heart, Lung, and Blood Institute’s (NHLBI) Advisory Council proposed that the institute evaluate the status and future directions in cardiac surgery. In response to this recommendation, the NHLBI convened a working group of cardiac surgeons on May 7 and 8, 2004, to assess the state of cardiac surgery research, identify critical gaps in current knowledge, determine areas of opportunity, and obtain specific recommendations for future research activities. The working group discussed surgical revascularization, novel surgical approaches, valvular research directions, biotechnology and cell-based therapy, heart failure, imaging modalities, and barriers to clinical research and presents its recommendations here.

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Background— Apelin has been shown ex vivo to be a potent cardiac inotrope. This study was undertaken to evaluate the in vivo effects of apelin on cardiac function in native and ischemic cardiomyopathic rat hearts using a novel combination of a perivascular flow probe and a conductance catheter. Methods and Results— Native rats (n =32) and rats in heart failure 6 weeks after left anterior descending coronary artery ligation (n =22) underwent median sternotomy with placement of a perivascular flow probe around the ascending aorta and a pressure volume conductance catheter into the left ventricle. Compared with sham-operated rats, the ligated rats had significantly decreased baseline Pmax and max dP/dt. Continuous infusion of apelin at a rate of 0.01 μg/min for 20 minutes significantly increased Pmax and max dP/dt compared with infusion of vehicle alone in both native and failing hearts. Apelin infusion increased cardiac contractility, indicated by a significant increase in stroke volume (SV) without a change in left ventricular end diastolic volume (102±16% change from initial SV versus 26±20% for native animals, and 110±30% versus 26±11% for ligated animals), as well as an increase in preload recruitable stroke work (180±24 mm Hg versus 107±9 mm Hg for native animals). Conclusions— The present study is the first to show that apelin has positive inotropic effects in vivo in both normal rat hearts and rat hearts in failure after myocardial infarction. Apelin may have use as an acute inotropic agent in patients with ischemic heart failure.

Background— Enhanced activity of matrix metalloproteinases (MMPs) has been associated with extracellular matrix degradation and ischemic heart failure in animal models and human patients. This study evaluated the effects of MMP inhibition by gene transfer of TIMP-1 in a rat model of ischemic cardiomyopathy. Methods and Results— Rats underwent ligation of the left anterior descending coronary artery with direct intramyocardial injection of replication-deficient adenovirus encoding TIMP-1 (n=8) or null virus as control vector (n=8), and animals were analyzed after 6 weeks. Both systolic and diastolic cardiac function was significantly preserved in the TIMP-1 group compared with control animals (maximum left ventricular [LV] pressure: TIMP-1 70±10 versus control 56±12 mmHg, P P P P P P P Conclusions— TIMP-1 gene transfer inhibits MMP activity and preserves cardiac function and geometry in ischemic cardiomyopathy. The reduction in myocardial fibrosis may be primarily responsible for the improved diastolic function in treated animals. TIMP-1 overexpression is a promising therapeutic target for continued investigation.

Background— Despite advances in surgical and percutaneous coronary revascularization, ongoing ischemia that is not amenable to standard revascularization techniques is a major cause of morbidity and mortality. Hepatocyte Growth Factor (HGF) has potent angiogenic and anti-apoptotic activities, and this study evaluated the functional and biochemical effects of HGF gene transfer in a rat model of postinfarction heart failure. Methods and Results— Lewis rats underwent ligation of the left anterior descending coronary artery with direct intramyocardial injection of replication-deficient recombinant adenovirus encoding HGF (n=10) or empty null virus as control (n=9), and animals were analyzed after six weeks. Pressure-volume conductance catheter measurements demonstrated significantly preserved contractile function in the HGF group compared with Null control animals as measured by maximum developed LV pressure (79±5 versus 56±4 mm Hg, P P P P P L expression in the HGF animals. Conclusions— Hepatocyte Growth Factor gene transfer following a large myocardial infarction results in significantly preserved myocardial function and geometry, and is associated with significant angiogenesis and a reduction in apoptosis. This therapy may be useful as an adjunct or alternative to standard revascularization techniques in patients with ischemic heart failure.

Apoptosis secondary to acute ischemia and chronic remodeling is implicated as a mediator of heart failure. This study was designed to assess the effect of in vivo viral gene transfer of the anti-apoptotic factor Bcl-2 to block apoptosis and preserve ventricular geometry and function.In a rabbit model of regional ischemia followed by reperfusion, an experimental group treated with adeno-Bcl-2 was compared with a control group receiving empty vector adeno-null. Function was assessed by echocardiography, and sonomicrometry of the border zone was compared with the normal left ventricle (LV). Animals were killed at 6 weeks, and an additional group was killed after 3 days to see whether virus administration conferred an immediate effect. Animals that were administered Bcl-2 maintained higher ejection fractions at 2, 4, and 6 weeks compared with controls. Sonomicrocrystals demonstrated greater protection of border zone fractional shortening at 6 weeks. The Bcl-2 group had superior preservation of LV geometry with less ventricular dilatation and wall thinning. There was also reduced apoptosis compared with the controls. Finally, in the animals killed at 3 days, no functional difference was observed between the Bcl-2 and control groups.Gene transfer of Bcl-2 preserves LV function after ischemia despite the absence of an observed acute protective effect. The benefit at 6 weeks is postulated to result from a Bcl-2-mediated reduction in apoptosis and ventricular remodeling. Adeno-Bcl-2 administration offers a potential strategy to protect the heart from late postischemic heart failure.

Background Apoptosis secondary to acute ischemia and chronic remodeling is implicated as a mediator of heart failure. This study was designed to assess the effect of in vivo viral gene transfer of the anti-apoptotic factor Bcl-2 to block apoptosis and preserve ventricular geometry and function. Methods and Results In a rabbit model of regional ischemia followed by reperfusion, an experimental group treated with adeno-Bcl-2 was compared with a control group receiving empty vector adeno-null. Function was assessed by echocardiography, and sonomicrometry of the border zone was compared with the normal left ventricle (LV). Animals were killed at 6 weeks, and an additional group was killed after 3 days to see whether virus administration conferred an immediate effect. Animals that were administered Bcl-2 maintained higher ejection fractions at 2, 4, and 6 weeks compared with controls. Sonomicrocrystals demonstrated greater protection of border zone fractional shortening at 6 weeks. The Bcl-2 group had superior preservation of LV geometry with less ventricular dilatation and wall thinning. There was also reduced apoptosis compared with the controls. Finally, in the animals killed at 3 days, no functional difference was observed between the Bcl-2 and control groups. Conclusions Gene transfer of Bcl-2 preserves LV function after ischemia despite the absence of an observed acute protective effect. The benefit at 6 weeks is postulated to result from a Bcl-2–mediated reduction in apoptosis and ventricular remodeling. Adeno–Bcl-2 administration offers a potential strategy to protect the heart from late postischemic heart failure.

The Society of Thoracic Surgeons' National Cardiac Database (NCD), which is housed and managed at the Duke Clinical Research Institute, has set the standard for effective professional society–sponsored clinical registries. Nearly 90% of US hospitals performing cardiac surgery participate in the NCD. In addition to accruing mortality and morbidity outcomes information from >3.6 million cardiac surgery patients since 1989, the NCD has been used to develop risk models for cardiac surgery procedures that are widely used to assess the appropriateness of surgical intervention. The NCD also has been used for continuous quality improvement (CQI) efforts when tracking process measures of care in cardiac surgery patients, such as the use of the internal mammary artery in coronary artery bypass grafting (CABG) procedures, or the use of preoperative β-blockade therapy.1 Article see p 39 This present report clearly demonstrates the effectiveness of a straightforward CQI intervention, ensuring that patients received appropriate discharge medications after CABG.2 Some would dispute the authors' characterization of this intervention as “low intensity.” In fact, it is a serious intervention, because coronary atherosclerosis is a lifetime illness. Established coronary artery disease requires effective secondary prevention measures after bypass surgery to sustain cardiac improvement and lasting health. The authors accurately describe the occasion of discharge instruction for CABG patients as a teachable moment. Unfortunately, in our compartmentalized healthcare delivery system, some cardiac patients do not receive a full lesson plan on how to deal with their coronary …

The American College of Cardiology/American Heart Association (ACC/AHA) Guidelines for the Management of Patients With Acute Myocardial Infarction have been reviewed over the past 2.5 years since their initial publication in the Journal of the American College of Cardiology (1996;28:1328–1428) to ensure their continued relevancy. The guidelines have been updated to include the most significant advances that have occurred in the management of patients with acute myocardial infarction (AMI) during that time frame. This update was developed to keep the guidelines current without republishing the entire document. This effort represents a new procedure of the ACC/AHA Task Force on Practice Guidelines. These guidelines will be reviewed and updated as necessary until it is deemed appropriate to revise and republish the entire document. The guidelines, incorporating the update, are available on the Web sites of both the American College of Cardiology (www.acc.org) and the American Heart Association (www.americanheart.org). In the Web site version, deleted text is indicated by strikeout, and new/revised text is presented as double-underlined type. Reprints of the original document with the revised sections appended are available from both organizations (see information below). The following is a listing of the recommendations made by the ACC/AHA Task Force on Practice Guidelines in the ACC/AHA Task Force Report “ACC/AHA Guidelines for the Management of Patients With Acute Myocardial Infarction.” More detailed information regarding the evidence and the rationale for these recommendations can be found in the full text of the guidelines themselves, which appears in the November 1996 and September 1999 (update) issues of the Journal of the American College of Cardiology. As in previous guidelines, the American College of Cardiology and the American Heart Association have used the following classification system in which indications for a diagnostic procedure, a particular therapy, or intervention are designated as: Class I: Conditions for …

Improvements in solid-state digital technology have enhanced transtelephonic transmission of electrocardiography (ECG) data and increased the accuracy of software-based analysis systems. These advances, in addition to better signal quality and greater computer arrhythmia interpretation capabilities, have opened new potential uses for ambulatory electrocardiography (AECG). Traditional uses of AECG for arrhythmia detection have expanded as the result of increased use of multichannel and telemetered signals. The clinical application of arrhythmia monitoring to assess drug and device efficacy has been further defined by new studies. The analysis of transient ST-segment deviation remains controversial, but considerably more data are now available, especially about the prognostic value of detecting asymptomatic ischemia. Heart rate variability (HRV) analysis has shown promise for predicting mortality rates in cardiac patients at high risk. Despite these advances, a true automated analysis system has not been perfected and technician/physician participation is still essential. The widespread availability and low cost of personal computers and workstations has allowed for the development of extremely sophisticated and automated signal processing algorithms. Current AECG equipment provides for the detection and analysis of arrhythmias and ST-segment deviation as well as more sophisticated analyses of R-R intervals, QRS-T morphology including late potentials, Q-T dispersion, and T-wave alternans. There are 2 categories of AECG recorders: continuous recorders, typically used for 24 to 48 hours to investigate symptoms and ECG events that are likely to occur within that time frame, and intermittent recorders, which may be used for long periods of time (weeks to months) to provide briefer, intermittent recordings for investigating events that occur infrequently. ### A. Continuous Recorders Rapidly evolving technologies now allow for direct recording of the ECG signal in a digital format using solid-state recording devices. The direct digital recording avoids all of the biases introduced by the mechanical features of tape recording devices and the problems associated with …

A. Organization of Committee and Evidence Review The American College of Cardiology/American Heart Association (ACC/AHA) Task Force on Practice Guidelines was formed to make recommendations regarding the diagnosis and treatment of patients with known or suspected cardiovascular disease. Ischemic heart disease is the single leading cause of death in the United States. The most common manifestation of this disease is chronic stable angina. Recognizing the importance of the management of this common entity and the absence of national clinical practice guidelines in this area, the task force formed the Committee on Management of Patients With Chronic Stable Angina to develop guidelines for the management of stable angina. Because this problem is frequently encountered in the practice of internal medicine, the task force invited the American College of Physicians–American Society of Internal Medicine (ACP–ASIM) to serve as a partner in this effort by identifying 3 general internists to serve on the committee. The guidelines are arbitrarily divided into 4 sections: diagnosis, risk stratification, treatment, and patient follow-up. Experienced clinicians will quickly recognize that the distinctions between these sections may be arbitrary and unrealistic for individual patients. However, for most clinical decision making, these divisions are helpful and facilitate the presentation and analysis of the available evidence. Detailed evidence was developed whenever possible. The weight of the evidence was ranked highest (A) if the data were derived from multiple randomized clinical trials involving large numbers of patients and intermediate (B) if the data were derived from a limited number of randomized trials involving small numbers of patients or careful analyses of nonrandomized studies or observational regis-tries. A low rank (C) was given when expert consensus was the primary basis for the recommendation. The customary ACC/AHA classifications I, II, and III are used in tables that summarize both the evidence and expert opinion and provide final recommendations for both patient …

This document revises and updates the original “Guidelines for Coronary Angiography,” published in 1987. This executive summary and recommendations appears in the May 4, 1999, issue of Circulation . The guidelines in their entirety, including the American College of Cardiology/American Heart Association (ACC/AHA) class I, II, and III recommendations, are published in the May 1999 issue of the Journal of the American College of Cardiology . Reprints of both the full text and executive summary and recommendations are available from both organizations. The frequent and still growing use of coronary angiography, its relatively high costs, its inherent risks, and the ongoing evolution of its indications provide the reasons for this revision. The committee appointed to develop this document included private practitioners and academicians who were selected to represent both experts in coronary angiography and senior clinician consultants. Representatives from the family practice and internal medicine professions were also included on the committee. In addition to reviewing the original document, the committee conducted a search of the literature for the 10 years preceding development of these guidelines. Evidence was compiled and ranked by the committee. Whereas randomized trials are often available for reference in the development of treatment guidelines, randomized trials regarding the use of diagnostic procedures such as coronary angiography are rarely available. This document uses the ACC/AHA classifications of class I, II, and III. These classes summarize the indications for coronary angiography as follows: Class I: Conditions for which there is evidence and/or general agreement that this procedure is useful and effective. Class II: Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of performing the procedure. Class IIa: Weight of evidence/opinion is in favor of usefulness/ efficacy. Class IIb: Usefulness/efficacy is less well established by evidence/opinion. Class III: Conditions for which there …

Percutaneous transluminal angioplasty (PTA) was used successfully to treat coarctation restenosis in seven patients. The patients were 10 months to 17 years old at the time of the angioplasty, and the initial coarctation repair had been performed 10 months to 16 1/2 years previously. PTA reduced the systolic pressure gradient across the coarctation from a mean of 58 mm Hg before the procedure to a mean of 13 mm Hg immediately after PTA. Follow-up has been from 1 to 14 months and indicates that the decrease in the systolic pressure gradient is persistent.

Transluminal balloon valvuloplasty was used to treat congenital pulmonary valve stenosis in 20 patients. Follow-up cardiac catheterization was performed in 11 patients at intervals of from 2 to 12 months after the procedure. Peak systolic pressure gradient across the pulmonic valve decreased from 68 +/- 27 to 23 +/- 5 mm Hg (p less than .001) after valvuloplasty. There were no complications. Follow-up catheterization demonstrated persistent relief of right ventricular hypertension in the patients with typical pulmonary valve stenosis.

Nifedipine, a slow-channel calcium blocker, is thought to provide useful myocardial protection during prolonged total ischemia and reperfusion. An isolated, isovolumic, feline heart model was used to asses the effectiveness of nifedipine in both cardioplegic (100 microgram/10 ml) and noncardioplegic (10 microgram/10 ml) doses for providing myocardial preservation during 90 minutes of hypothermic ischemic arrest and 45 minutes of normothermic reperfusion. Use of nifedipine was compared to hypothermia (27 degrees C) alone and to hypothermia with potassium cardioplegia. Ventricular function was assessed by recovery of isovolumic left ventricular developed pressure and dP/dt. Myocardial carbon dioxide tension (PCO2) and myocardial oxygen tension (PO2) were measured by mass spectrometry. Potassium cardioplegia and the higher dose of nifedipine resulted in immediate asystole. The rates of rise of PCO were greatest in the group receiving 10 microgram nifedipine and in the control group. The rates of rise in the two cardioplegic groups were significantly lower. Recovery of ventricular function was significantly lower with low-dose nifedipine than with potassium cardioplegia. Higher dose nifedipine resulted in a return of function, which was no different than with potassium cardioplegia. Morphologic protection was better with higher dose nifedipine and potassium cardioplegia than with either low-dose cardioplegia or hypothermia alone. These results demonstrate that nifedipine in a cardioplegic dose results in preservation of myocardial structure and function that is similar to that obtained with potassium cardioplegia. In lower noncardioplegic dose, nifedipine does not appear to offer additional protection compared to hypothermia alone. Whether persistent depression of ventricular contractility will limit nifedipine's clinical usefulness as a myocardial protection agent will require further study.