ACC/AHA Task Force Members Jeffrey L. Anderson, MD, FACC, FAHA, Chair, Jonathan L. Halperin, MD, FACC, FAHA, Chair-Elect, Nancy M. Albert, PhD, CCNS, CCRN, FAHA, Biykem Bozkurt, MD, PhD, FACC, FAHA, ...Ralph G. Brindis, MD, MPH, MACC, Mark A. Creager, MD, FACC, FAHA§§Task Force member during the writing effort., Lesley H. Curtis, PhD, FAHA, David DeMets, PhD, Robert A. Guyton, MD, FACC§§, Judith S. Hochman, MD, FACC, FAHA, Richard J. Kovacs, MD, FACC, FAHA, E. Magnus Ohman, MD, FACC, Susan J. Pressler, PhD, RN, FAHA, Frank W. Sellke, MD, FACC, FAHA, Win-Kuang Shen, MD, FACC, FAHA, William G. Stevenson, MD, FACC, FAHA§§, Clyde W. Yancy, MD, FACC, FAHA§§ Table of Contents Preamble... An organized and directed approach to a thorough review of evidence has resulted in the production of clinical practice guidelines that assist clinicians in selecting the best management strategy for an individual patient. ...clinical practice guidelines can provide a foundation for other applications, such as performance measures, appropriate use criteria, and both quality improvement and clinical decision support tools. ...in view of the increasing number of comparative effectiveness studies, comparator verbs and suggested phrases for writing recommendations for the comparative effectiveness of one treatment or strategy versus another are included for COR I and IIa, LOE A or B only.\n Charney Division of Cardiology; Associate Director, Health Care Center None None None None None None Craig R. Smith Content Reviewer Columbia University College of Physicians and Surgeons--Professor of Surgery; Chair, Department of Surgery; New York-Presbyterian Hospital/Columbia University Medical Center--Surgeon-in-Chief None None None Edwards Lifesciences--PI None None Ruth H. Strasser Content Reviewer--AIG Heart Centre,University Hospital, University of Technology, Dresden--Professor, Director, and Chair, Internal Medicine and Cardiology Clinic; Medical Director, Heart Centre None None None None Abbottdagger AstraZenecadagger Bayerdagger Biosensorsdagger Pfizerdagger None Rakesh Suri Content Reviewer Mayo Clinic--Associate Professor of Surgery None None None None Edwards Lifesciencesdagger Sorindagger St. Jude Medicaldagger None Vinod Thourani Content Reviewer--Surgeon Council Emory University Edward Lifesciences Sorin St. Jude Medical None Apica Cardiovasculardagger Maquet None None Alec Vahanian Content Reviewer Hospital Bichat--Department de Cardiologie Abbott Vascular Edwards Lifesciences Medtronic St. Jude Medical Valtech None None None None None Andrew Wang Content Reviewer Duke University Medical Center--Professor of Medicine None None None Abbott Vascularlow * Edwards Lifescienceslow * None Defendant, Sudden death, 2012 * This table represents the relationships of reviewers with industry and other entities that were disclosed at the time of peer review and determined to be relevant to this document. Names are listed in alphabetical order within each category of review.According to the ACC/AHA, a person has a relevant relationship IF: a) The relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the document; or b) The company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competing drug or device addressed in the document; or c) The person or a member of the person's household, has a reasonable potential for financial, professional or other personal gain or loss as a result of the issues/content addressed in the document.AATS indicates American Association for Thoracic Surgery; ACC, American College of Cardiology; AHA, American Heart Association; AIG, Association of International Governors; ASE, American Society of Echocardiography; DSMB, Data and Safety Monitoring Board; MRI, magnetic resonance imaging; NIH, National Institutes of Health; NYU, New York University; PARTNERS, Placement Of Aortic Transcatheter Valves; PI, Principal Investigator; SCA, Society of Cardiovascular Anesthesiologists; SCAI, Society for Cardiovascular Angiography and Interventions; STS, Society of Thoracic Surgeons; and VA, Veterans Affairs.
Abstract Most cardiomyopathies are familial diseases. Cascade family screening identifies asymptomatic patients and family members with early traits of disease. The inheritance is autosomal dominant ...in a majority of cases, and recessive, X-linked, or matrilinear in the remaining. For the last 50 years, cardiomyopathy classifications have been based on the morphofunctional phenotypes, allowing cardiologists to conveniently group them in broad descriptive categories. However, the phenotype may not always conform to the genetic characteristics, may not allow risk stratification, and may not provide pre-clinical diagnoses in the family members. Because genetic testing is now increasingly becoming a part of clinical work-up, and based on the genetic heterogeneity, numerous new names are being coined for the description of cardiomyopathies associated with mutations in different genes; a comprehensive nosology is needed that could inform the clinical phenotype and involvement of organs other than the heart, as well as the genotype and the mode of inheritance. The recently proposed MOGE(S) nosology system embodies all of these characteristics, and describes the morphofunctional phenotype (M), organ(s) involvement (O), genetic inheritance pattern (G), etiological annotation (E) including genetic defect or underlying disease/substrate, and the functional status (S) of the disease using both the American College of Cardiology/American Heart Association stage and New York Heart Association functional class. The proposed nomenclature is supported by a web-assisted application and assists in the description of cardiomyopathy in symptomatic or asymptomatic patients and family members in the context of genetic testing. It is expected that such a nomenclature would help group cardiomyopathies on their etiological basis, describe complex genetics, and create collaborative registries.
Objectives This study sought to report full 1-year results, detailed magnetic resonance imaging analysis, and determinants of efficacy in the prospective, randomized, controlled CADUCEUS ...(CArdiosphere-Derived aUtologous stem CElls to reverse ventricUlar dySfunction) trial. Background Cardiosphere-derived cells (CDCs) exerted regenerative effects at 6 months in the CADUCEUS trial. Complete results at the final 1-year endpoint are unknown. Methods Autologous CDCs (12.5 to 25 × 106 ) grown from endomyocardial biopsy specimens were infused via the intracoronary route in 17 patients with left ventricular dysfunction 1.5 to 3 months after myocardial infarction (MI) (plus 1 infused off-protocol 14 months post-MI). Eight patients were followed as routine-care control patients. Results In 13.4 months of follow-up, safety endpoints were equivalent between groups. At 1 year, magnetic resonance imaging revealed that CDC-treated patients had smaller scar size compared with control patients. Scar mass decreased and viable mass increased in CDC-treated patients but not in control patients. The single patient infused 14 months post-MI responded similarly. CDC therapy led to improved regional function of infarcted segments compared with control patients. Scar shrinkage correlated with an increase in viability and with improvement in regional function. Scar reduction correlated with baseline scar size but not with a history of temporally remote MI or time from MI to infusion. The changes in left ventricular ejection fraction in CDC-treated subjects were consistent with the natural relationship between scar size and ejection fraction post-MI. Conclusions Intracoronary administration of autologous CDCs did not raise significant safety concerns. Preliminary indications of bioactivity include decreased scar size, increased viable myocardium, and improved regional function of infarcted myocardium at 1 year post-treatment. These results, which are consistent with therapeutic regeneration, merit further investigation in future trials. (CArdiosphere-Derived aUtologous stem CElls to reverse ventricUlar dySfunction CADUCEUS; NCT00893360 )
Abstract Treatment of acute myocardial infarction (AMI) has improved significantly in recent years, but many patients have adverse left ventricular (LV) remodeling, a maladaptive change associated ...with progressive heart failure. Although this change is usually associated with large infarcts, some patients with relatively small infarcts have adverse remodeling, whereas other patients with larger infarcts (who survive the first several days after AMI) do not. This paper reviews the relevant data supporting the hypothesis that individual differences in the intensity of the post-AMI inflammatory response, involving 1 or more inflammatory-modulating pathways, may contribute to adverse LV remodeling. It concludes by outlining how individual variations in the inflammatory response could provide important novel therapeutic targets and strategies.
Abstract Aortic stenosis (AS) is one of the most common valvular diseases encountered in clinical practice. Current guidelines recommend aortic valve replacement (AVR) when the aortic valve is ...severely stenotic and the patient is symptomatic; however, a substantial proportion of patients with severe AS are asymptomatic at the time of first diagnosis. Although specific morphological valve features, exercise testing, stress imaging, and biomarkers can help to identify patients with asymptomatic severe AS who may benefit from early AVR, the optimal management of these patients remains uncertain and controversial. The current report presents a comprehensive review of the natural history and the diagnostic evaluation of asymptomatic patients with severe AS, and is followed by a meta-analysis from reported studies comparing an early AVR strategy to active surveillance, with an emphasis on the level of evidence substantiating the current guideline recommendations. Finally, perspectives on directions for future investigation are discussed.
Abstract Background Beta-blocker therapy after acute myocardial infarction (MI) improves survival. Beta-blocker doses used in clinical practice are often substantially lower than those used in the ...randomized trials establishing their efficacy. Objectives This study evaluated the association of beta-blocker dose with survival after acute MI, hypothesizing that higher dose beta-blocker therapy will be associated with increased survival. Methods A multicenter registry enrolled 7,057 consecutive patients with acute MI. Discharge beta-blocker dose was indexed to the target beta-blocker doses used in randomized clinical trials, grouped as >0% to 12.5%, >12.5% to 25%, >25% to 50%, and >50% of target dose. Follow-up vital status was assessed, with the primary endpoint of time-to-death right-censored at 2 years. Multivariable and propensity score analyses were used to account for group differences. Results Of 6,682 patients with follow-up (median 2.1 years), 91.5% were discharged on a beta-blocker (mean dose 38.1% of the target dose). Lower mortality was observed with all beta-blocker doses (p < 0.0002) versus no beta-blocker therapy. After multivariable adjustment, hazard ratios for 2-year mortality compared with the >50% dose were 0.862 (95% confidence interval CI: 0.677 to 1.098), 0.799 (95% CI: 0.635 to 1.005), and 0.963 (95% CI: 0.765 to 1.213) for the >0% to 12.5%, >12.5% to 25%, and >25% to 50% of target dose groups, respectively. Multivariable analysis with an extended set of covariates and propensity score analysis also demonstrated that higher doses were not associated with better outcome. Conclusions These data do not demonstrate increased survival in patients treated with beta-blocker doses approximating those used in previous randomized clinical trials compared with lower doses. These findings provide the rationale to re-engage in research to establish appropriate beta-blocker dosing after MI to derive optimal benefit from this therapy. (The PACE-MI Registry Study—Outcomes of Beta-blocker Therapy After Myocardial Infarction OBTAIN: NCT00430612 )
Exercise testing has an established role in the evaluation of patients with valvular heart disease and can aid clinical decision making. Because symptoms may develop slowly and indolently in chronic ...valve diseases and are often not recognized by patients and their physicians, the symptomatic, blood pressure, and electrocardiographic responses to exercise can help identify patients who would benefit from early valve repair or replacement. In addition, stress echocardiography has emerged as an important component of stress testing in patients with valvular heart disease, with relevant established and potential applications. Stress echocardiography has the advantages of its wide availability, low cost, and versatility for the assessment of disease severity. The versatile applications of stress echocardiography can be tailored to the individual patient with aortic or mitral valve disease, both before and after valve replacement or repair. Hence, exercise-induced changes in valve hemodynamics, ventricular function, and pulmonary artery pressure, together with exercise capacity and symptomatic responses to exercise, provide the clinician with diagnostic and prognostic information that can contribute to subsequent clinical decisions. Nevertheless, there is a lack of convincing evidence that the results of stress echocardiography lead to clinical decisions that result in better outcomes, and therefore large-scale prospective randomized studies focusing on patient outcomes are needed in the future.
A Report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, Society for Cardiovascular Angiography and Interventions, American Association for Thoracic Surgery, ...American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Failure Society of America, Heart Rhythm Society, Society of Critical Care Medicine, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and Society of Thoracic Surgeons Technical Panel Pamela S. Douglas, MD, MACC, FAHA, FASE, Moderator Manesh R. Patel, MD, FACC, Writing Group Liaison Steven R. Bailey, MD, FACC, FSCAI, FAHA, Writing Group Liaison Philip Altus, MD, MACPdaggerAmerican College of Physicians Representative Denise D. Barnard, MD, FACCdouble daggerHeart Failure Society of America Representative James C. Blankenship, MD, MACC, FSCAI* Donald E. Casey, Jr, MD, MPH, MBA, FACP, FAHAdagger Larry S. Dean, MD, FACC, FAHA, FSCAI* Reza Fazel, MD, MSc, FACC§American Society of Nuclear Cardiology Representative Ian C. Gilchrist, MD, FACC, FSCAI, FCCM||Society of Critical Care Medicine Representative Clifford J. Kavinsky, MD, PhD, FACC, FSCAI* Susan G. Lakoski, MD, MS¶American Heart Association Representative D. Elizabeth Le, MD, FACC, FASE#American Society of Echocardiography Representative John R. Lesser, MD, FACC, FSCAI, FSCCT**Society of Cardiovascular Computed Tomography Representative Glenn N. Levine, MD, FACC, FAHAdaggerdaggerSociety for Cardiovascular Magnetic Resonance Representative Roxana Mehran, MD, FACC, FACP, FCCP, FESC, FAHA, FSCAIdouble daggerdouble daggerAmerican College of Cardiology Foundation Representative Andrea M. Russo, MD, FACC, FHRS§§Heart Rhythm Society Representative Matthew J. Sorrentino, MD, FACCdouble daggerdouble dagger Mathew R. Williams, MD, FACC|||American Association for Thoracic Surgery/Society of Thoracic Surgeons Representative John B. Wong, MD, FACPdouble daggerdouble dagger Appropriate Use Criteria Task Force Michael J. Wolk, MD, MACC, Chair Steven R. Bailey, MD, FACC, FSCAI, FAHA Pamela S. Douglas, MD, MACC, FAHA, FASE Robert C. Hendel, MD, FACC, FAHA, FASNC Christopher M. Kramer, MD, FACC, FAHA James K. Min, MD, FACC Manesh R. Patel, MD, FACC Leslee Shaw, PhD, FACC, FASNC Raymond F. Stainback, MD, FACC, FASE Joseph M. Allen, MA Table of Contents Abstract... Preface In an effort to respond to the need for the rational use of cardiovascular services, including imaging and invasive procedures in the delivery of high-quality care, the American College of Cardiology Foundation (ACCF) in collaboration with other professional organizations has undertaken a process to determine the appropriate use of cardiovascular procedures for selected patient indications.
Abstract The prevalence of patients with concomitant heart failure (HF) and diabetes mellitus (DM) continues to increase with the general aging of the population. In patients with chronic HF, ...prevalence of DM is 24% compared with 40% in those hospitalized with worsening HF. Patients with concomitant HF and DM have diverse pathophysiologic, metabolic, and neurohormonal abnormalities that potentially contribute to worse outcomes than those without comorbid DM. In addition, although stable HF outpatients with DM show responses that are similar to those of patients without DM undergoing evidence-based therapies, it is unclear whether hospitalized HF patients with DM will respond similarly to novel investigational therapies. These data support the need to re-evaluate the epidemiology, pathophysiology, and therapy of HF patients with concomitant DM. This paper discusses the role of DM in HF patients and underscores the potential need for the development of targeted therapies.
Abstract Objective Paravalvular regurgitation is a known complication after transcatheter and sutureless aortic valve replacement. Paravalvular regurgitation also may develop in patients undergoing ...percutaneous mitral valve replacement. There are few studies on contemporary surgical valve replacement for comparison. We sought to determine the contemporary occurrence of paravalvular regurgitation after conventional surgical valve replacement. Methods We performed a single-center retrospective database review involving 1774 patients who underwent valve replacement surgery from April 2004 to December 2012: aortic in 1244, mitral in 386, and combined aortic and mitral in 144. Follow-up echocardiography was performed in 73% of patients. Patients with endocarditis were analyzed separately from noninfectious paravalvular leaks. Statistical comparisons were performed to determine differences in paravalvular regurgitation incidence and survival. Results During follow-up, 1+ or greater (mild or more) paravalvular regurgitation occurred in 2.2% of aortic cases and 2.9% of mitral cases. There was 2+ or greater (moderate or more) paravalvular regurgitation in 0.9% of aortic and 2.2% of mitral cases ( P = .10). After excluding endocarditis, late noninfectious regurgitation 2+ or greater was detected in 0.5% of aortic and 0.4% of mitral cases ( P = .93); there were no reoperations or percutaneous closures for noninfectious paravalvular regurgitation. Conclusions In an academic medical center, the overall rate of paravalvular regurgitation is low, and late clinically significant noninfectious paravalvular regurgitation is rare. The benchmark for paravalvular regurgitation after conventional valve replacement is high and should be considered when evaluating patients for transcatheter or sutureless valve replacement.
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