Previous studies suggest worse outcomes in patients with variant transthyretin cardiac amyloidosis (ATTR-CA) because of valine-to-isoleucine substitution at Position 122 (V122I) (ATTRv-CA) compared with patients with wild-type (WT) disease (ATTRwt-CA). Given V122I is almost exclusively found in Black patients, it is unclear if this is attributable to the biology of genotype or racial differences. Patients with ATTR-CA diagnosed between January 2001 and August 2021 were characterized into 3 categories: (1) White with ATTRwt-CA (White-WT); (2) Black with V122I ATTRv-CA (Black-V122I), and (3) Black with ATTRwt-CA (Black-WT). Event-free survival (composite of death, left ventricular assist device, or cardiac transplant) was evaluated using univariable and multivariable analyses over a median follow-up of 1.6 (0.7 to 2.90) years. Of 694 ATTR-CA patients, 502 (72%) were White-WT, 139 Black-V122I (20%), and 53 Black-WT (8%). Notably, 28% of Black patients with ATTR-CA had WT disease and not the V122I variant. Using multivariable modeling to adjust for several prognostic features, Black-V122I had higher risk of the composite adverse outcome compared with a grouped cohort of patients with WT disease (White-WT and Black-WT) (hazard ratio [HR] 1.82, confidence interval [CI] 1.30-2.56, p < 0.001). Furthermore, the Black cohort as a whole (Black-V122I and Black-WT) demonstrated greater risk of adverse outcomes compared with White-WT (HR 1.63, CI 1.19-2.24, p=0.002). Black-V122I had greater risk of the primary end point compared with White-WT (HR 1.80, CI 1.27-2.56, p=0.001). Black patients with ATTR-CA have worse event-free survival than White-WT despite risk adjustment. However, it remains unclear whether this is driven by differences in race or genotype given the smaller number of Black-WT patients. Approximately one-quarter of Black patients had WT, of which a greater proportion were female compared with White-WT.
Coronary artery disease (CAD) causes significant morbidity and mortality. Accurate noninvasive evaluation is important to facilitate appropriate diagnosis and treatment. The ubiquitous nature of CAD requires all practitioners, regardless of their specialty, to be familiar with noninvasive diagnostic modalities. This article reviews currently available tests, including specific features, diagnostic and prognostic value, strengths, and limitations.
Statistical analyses are a crucial component of the biomedical research process and are necessary to draw inferences from biomedical research data. The application of sound statistical methodology is a prerequisite for publication in the American Heart Association (AHA) journal portfolio. The objective of this document is to summarize key aspects of statistical reporting that might be most relevant to the authors, reviewers, and readership of AHA journals. The AHA Scientific Publication Committee convened a task force to inventory existing statistical standards for publication in biomedical journals and to identify approaches suitable for the AHA journal portfolio. The experts on the task force were selected by the AHA Scientific Publication Committee, who identified 12 key topics that serve as the section headers for this document. For each topic, the members of the writing group identified relevant references and evaluated them as a resource to make the standards summarized herein. Each section was independently reviewed by an expert reviewer who was not part of the task force. Expert reviewers were also permitted to comment on other sections if they chose. Differences of opinion were adjudicated by consensus. The standards presented in this report are intended to serve as a guide for high-quality reporting of statistical analyses methods and results.
HomeCirculation: Cardiovascular ImagingVol. 14, No. 1ISCHEMIA Trial Free AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyRedditDiggEmail Jump toFree AccessEditorialPDF/EPUBISCHEMIA TrialAre We Still Fighting the Last War? Rory Hachamovitch, MD, MSc Prem SomanMD, PhD Rory HachamovitchRory Hachamovitch Rory Hachamovitch, MD, MSc, Cardiovascular Medicine J1-5, Cleveland Clinic, Euclid Ave, Cleveland, OH 44195. Email E-mail Address: [email protected] or E-mail Address: [email protected] Cardiovascular Imaging Section, Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic Foundation, OH (R.H.). Search for more papers by this author , Prem SomanPrem Soman https://orcid.org/0000-0003-1425-6536 University of Pittsburgh, PA (P.S.). Search for more papers by this author Originally published18 Jan 2021https://doi.org/10.1161/CIRCIMAGING.120.012319Circulation: Cardiovascular Imaging. 2021;14:e012319This article is a commentary on the followingMyocardial Ischemia in the Management of Chronic Coronary Artery DiseaseSee Article by GibbonsWhile the assessment of stress-induced ischemia has long been used to guide the clinical management of stable ischemic heart disease (SIHD), the value of this approach in the identification of therapeutic selection is an unproven hypothesis. After decades of randomized clinical trials (RCT)—including recent trials comparing revascularization and optimal medical therapy (OMT) to OMT alone—the identification of the patient with SIHD who is an optimal revascularization candidate remains uncertain.1–5 The current issue of Circulation: Cardiovascular Imaging contains a historic overview of investigations examining the role of myocardial ischemia in clinical management as a prelude to a discussion of the ISCHEMIA trial (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches).6 This outstanding review touches upon many of the underlying issues and challenges faced when examining these questions.Despite the use of ischemia ascertainment in the inclusion criteria of both the COURAGE trial (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) and the BARI 2D trial (Bypass Angioplasty Revascularization Investigation 2 Diabetes), both failed to demonstrate any survival benefit with the addition of revascularization to OMT.1,7 The failure to define a therapeutic role for ischemia assessment to select revascularization candidates in both the overall study and the relevant nuclear substudies suggested that angiographic characterization of coronary anatomy and, in turn, stress imaging to identify angiography candidates, may not be routinely necessary.On the contrary, the FAME 2 trial (Fractional Flow Reserve versus Angiography for Multivessel Evaluation 2),4 using physiological metrics to guide patient management, claimed improved outcomes for a physiology-base strategy compared with an anatomy-based strategy. Similarly, large, single center observational series of patients referred for clinically ordered cardiac single photon emission-computed tomography (SPECT) MPI suggested that revascularization was associated with improved survival compared with medical therapy alone when an ischemia threshold was exceeded (≈>15% of the myocardium ischemic).8,9 It should be noted that medical therapy in these observational studies was undefined and, as shown in large, prospective, multicenter observational studies, likely suboptimal.10 These observational studies also introduced the paradigm that post-CV imaging patient risk is distinct from improving outcomes with a specific treatment strategy. Those patients who accrued a survival benefit were not those at greatest clinical risk (reduced left ventricular function, myocardial scar) but those with the greatest amount of inducible ischemia.8,11,12Although prior guidelines included a class I recommendation for revascularization in the setting of anatomic CAD with jeopardized myocardium, this use of cardiac imaging is an unproven hypothesis. This hypothesis was, in part, addressed by the recently published ISCHEMIA trial.13,14 Compared with prior RCTs, the initial design of the ISCHEMIA trial13,14 offered an original approach. Enrollment focused on patients with moderate to severe ischemia on stress imaging as determined by core laboratory read (after significant left main lesions were excluded by computed tomographic angiography), and the original trial design was “…adequately powered to demonstrate whether routine revascularization reduces cardiovascular death or nonfatal MI in patients with SIHD and at least moderate ischemia” (end points less susceptible to unintended bias).15,16While ISCHEMIA will undoubtably impact clinical practice, there are several serious issues related to the trial to be considered. Design trade-offs were made to improve generalizability and enhance recruitment. ISCHEMIA’s design used a lower threshold of ischemia (>10% ischemia) than that reported by observational studies using SPECT (>15% ischemia). Further, the trial was inclusive of all stress imaging modalities (SPECT, positron emission tomography), stress echocardiography, and cardiac magnetic resonance imaging, although no data was available at the time justifying this threshold for other modalities.13 Finally, while the observational studies above focused on mortality end points, the ISCHEMIA trial used a composite end point, possibly contributing to the difference in results.During the course of the trial, with an eye to improve recruitment, trial leadership expanded qualifying testing to include exercise treadmill testing without imaging and changed the primary end point to include resuscitated cardiac arrest and hospitalization for unstable angina or heart failure (the latter an option included in the original protocol). Also, enrollment of patients without core laboratory ascertainment of the ischemia threshold was permitted, resulting in about 1 in 7 of patients randomized on the basis of stress imaging having only mild or no ischemia. Of the 5179 patients randomized in ISCHEMIA, only 970 patients underwent stress SPECT with >15% ischemia reported. Finally, it is important to note that, like many RCTs, the proportion of minorities and women recruited were relatively low (<25% women, 4% Black, 16% Hispanic) and the use of bypass surgery in patients with diabetes or multivessel CAD possibly suboptimal.ISCHEMIA’s primary results indicated that in patients with SIHD with moderate-severe ischemia, revascularization did not reduce a composite end point of all-cause mortality, myocardial infarction, or MACE compared with OMT.14 This trial also assessed patient-perceived well-being as measured by the Seattle Angina Questionnaire.17 The authors reported that compared with patients managed conservatively, patients in the invasive arm had greater improvement in angina-related health status. These improvements were more notable in patients with angina at baseline.While the health outcomes portion of ISCHEMIA confirmed improvement in angina frequency with revascularization and OMT over OMT alone, this change was relatively modest at 36 months (0–100 scale with higher scores reflecting less symptoms; mean Seattle Angina Questionnaire 88.6 versus 86.3). The ISCHEMIA cohort was less symptomatic than those in prior RCT (eg, COURAGE). Baseline Seattle Angina Questionnaire frequency score in ISCHEMIA was 81.5 (versus 68.5 in COURAGE) with 35.5% of ISCHEMIA patients having no angina at the time of enrollment. It is important to note when interpreting Seattle Angina Questionnaire scores that a “…change in score of 10 points equaled or exceeded a change perceptible to patients” and constituted a clinically important difference in scores.18 Thus, while the invasive approach resulted in statistically significant improvements in patient symptoms, the magnitude of these gains may have often been marginal.In his review, Dr Gibbons 6 examines these issues closely and lays out the issues leading to a relatively low risk and prevalence of angina in the recruited cohort. As he outlines, numerous studies have documented the decreasing prevalence of abnormal stress imaging studies, particularly studies with extensive ischemia. Similarly, the mortality rates in SIHD cohorts have declined. Pooled analysis of early RCTs examining revascularization versus medical therapy in SIHD reported annualized mortality rates of 3.1% with medical therapy over the initial 10 years after randomization.5 The observational study claiming a 15% ischemia threshold for revascularization benefit in patients tested from 1991 to 1997 reported an overall annualized mortality of 3.3%.9 These rates have been strikingly lower with recent trials and registries with annual mortality rates in the range of 1.3% to 1.7% or less.1–3,19 These lower rates suggest that even if ISCHEMIA had limited the inclusion criteria to patients with >15% ischemia by SPECT, in the context of modern pharmacotherapy and preventive measures, a negative study would have resulted from reduced patient event rates compromising study power. It may be said that the patient management algorithms examined by trials such as ISCHEMIA and COURAGE are based on clinical thinking and data from a past era with inferior treatment options and higher event rates. With the rapid advancement of knowledge regarding CV imaging and treatment of atherosclerosis and subsequent risk, the results of these trials may be indicative of the need for examining new approaches to patient evaluation with a greater focus on atherosclerosis and endothelial function and the possible role of advanced CV imaging.With the addition of ISCHEMIA’s results to our knowledge base, the role of coronary artery revascularization appears to be limited to discrete patient subgroups, such as patients with unacceptable angina, or with severe left ventricular systolic dysfunction secondary to SIHD (as identified by the STICH Trial [Surgical Treatment for Ischemic Heart Failure]).20 On the contrary, patient subgroups with high risk criteria, often considered revascularization candidates in the past, have been shown to do equally well with OMT. These trials do not suggest a failure of revascularization techniques as much as a triumph of medical therapy and preventive measures. Perhaps, they also teach us that assessment of atherosclerosis burden, vasomotor function, and plaque stability are important future foci for advanced CV imaging.It is perhaps important to remind ourselves that ISCHEMIA was a randomized trial of therapies, not diagnostic imaging strategies. The results of ISCHEMIA are applicable to only the minority of stable chest pain patients who are proven to have obstructive CAD and myocardial ischemia. They do not advise us as to the optimal diagnostic strategy for CAD and myocardial ischemia. Nevertheless, several imaging-related questions have arisen since the publication of the trial particularly related to the relevance of functional imaging and the universal need for anatomic imaging to exclude left main disease. Myocardial perfusion imaging will continue to have a central role in the evaluation of stable chest pain since it uniquely establishes an anginal cause for the patient’s symptoms (which may prognosticate improvement of symptoms with revascularization in a manner than anatomy and FFR do not21) and determines LV systolic function, both critical evaluations in the context of ISCHEMIA. It can also suggest the presence of extensive proximal or left main obstructive CAD. A large, randomized trial generalizable to prevalent practice in the United States does not suggest harm from missed left main disease with functional testing and suggests comparable patient outcomes with anatomic or functional testing.22AcknowledgmentsWe acknowledge the assistance and input of Dr Venkatesh Murthy (University of Michigan).Disclosures Disclosures provided by Drs Hachamovitch and Soman in compliance with American Heart Association’s annual Journal Editor Disclosure Questionnaire are available at https://www.ahajournals.org/pb-assets/policies/COI_09_2020-1600719273583.pdf.FootnotesThe opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.Rory Hachamovitch, MD, MSc, Cardiovascular Medicine J1-5, Cleveland Clinic, Euclid Ave, Cleveland, OH 44195. Email [email protected]org or [email protected]comReferences1. Boden WE, O’Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk WJ, Knudtson M, Dada M, Casperson P, Harris CL, et al.; COURAGE Trial Research Group. Optimal medical therapy with or without PCI for stable coronary disease.N Engl J Med. 2007; 356:1503–1516. doi: 10.1056/NEJMoa070829CrossrefMedlineGoogle Scholar2. De Bruyne B, Pijls NH, Kalesan B, Barbato E, Tonino PA, Piroth Z, Jagic N, Möbius-Winkler S, Mobius-Winckler S, Rioufol G, et al.; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease.N Engl J Med. 2012; 367:991–1001. doi: 10.1056/NEJMoa1205361CrossrefMedlineGoogle Scholar3. Douglas PS, Hoffmann U, Lee KL, Mark DB, Al-Khalidi HR, Anstrom K, Dolor RJ, Kosinski A, Krucoff MW, Mudrick DW, et al.; PROMISE investigators. PROspective Multicenter Imaging Study for Evaluation of chest pain: rationale and design of the PROMISE trial.Am Heart J. 2014; 167:796–803.e1. doi: 10.1016/j.ahj.2014.03.003CrossrefMedlineGoogle Scholar4. Pijls NH, Fearon WF, Tonino PA, Siebert U, Ikeno F, Bornschein B, van’t Veer M, Klauss V, Manoharan G, Engstrøm T, et al.; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention in patients with multivessel coronary artery disease: 2-year follow-up of the FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) study.J Am Coll Cardiol. 2010; 56:177–184. doi: 10.1016/j.jacc.2010.04.012CrossrefMedlineGoogle Scholar5. Yusuf S, Zucker D, Peduzzi P, Fisher LD, Takaro T, Kennedy JW, Davis K, Killip T, Passamani E, Norris R. Effect of coronary artery bypass graft surgery on survival: overview of 10-year results from randomised trials by the Coronary Artery Bypass Graft Surgery Trialists Collaboration.Lancet. 1994; 344:563–570. doi: 10.1016/s0140-6736(94)91963-1CrossrefMedlineGoogle Scholar6. Gibbons RJ. Myocardial ischemia in the management of chronic coronary artery disease - past and present.Circ Cardiovasc Imaging. 2021; 14:e011615. doi: 10.1161/CIRCIMAGING.120.011615LinkGoogle Scholar7. Frye RL, August P, Brooks MM, Hardison RM, Kelsey SF, MacGregor JM, Orchard TJ, Chaitman BR, Genuth SM, Goldberg SH, et al.. A randomized trial of therapies for type 2 diabetes and coronary artery disease.N Engl J Med. 2009; 360:2503–2515. doi: 10.1056/NEJMoa0805796CrossrefMedlineGoogle Scholar8. Hachamovitch R, Hayes SW, Friedman JD, Cohen I, Berman DS. Comparison of the short-term survival benefit associated with revascularization compared with medical therapy in patients with no prior coronary artery disease undergoing stress myocardial perfusion single photon emission computed tomography.Circulation. 2003; 107:2900–2907. doi: 10.1161/01.CIR.0000072790.23090.41LinkGoogle Scholar9. Hachamovitch R, Rozanski A, Shaw LJ, Stone GW, Thomson LE, Friedman JD, Hayes SW, Cohen I, Germano G, Berman DS. Impact of ischaemia and scar on the therapeutic benefit derived from myocardial revascularization vs. medical therapy among patients undergoing stress-rest myocardial perfusion scintigraphy.Eur Heart J. 2011; 32:1012–1024. doi: 10.1093/eurheartj/ehq500CrossrefMedlineGoogle Scholar10. Hachamovitch R, Nutter B, Hlatky MA, Shaw LJ, Ridner ML, Dorbala S, Beanlands RS, Chow BJ, Branscomb E, Chareonthaitawee P, et al.; SPARC Investigators. Patient management after noninvasive cardiac imaging results from SPARC (Study of myocardial perfusion and coronary anatomy imaging roles in coronary artery disease).J Am Coll Cardiol. 2012; 59:462–474. doi: 10.1016/j.jacc.2011.09.066CrossrefMedlineGoogle Scholar11. Hachamovitch R. Does ischemia burden in stable coronary artery disease effectively identify revascularization candidates? Ischemia burden in stable coronary artery disease effectively identifies revascularization candidates.Circ Cardiovasc Imaging. 2015; 8:discussion p 8. doi: 10.1161/CIRCIMAGING.113.000352LinkGoogle Scholar12. Hachamovitch R, Rozanski A, Hayes SW, Thomson LE, Germano G, Friedman JD, Cohen I, Berman DS. Predicting therapeutic benefit from myocardial revascularization procedures: are measurements of both resting left ventricular ejection fraction and stress-induced myocardial ischemia necessary?J Nucl Cardiol. 2006; 13:768–778. doi: 10.1016/j.nuclcard.2006.08.017CrossrefMedlineGoogle Scholar13. Maron DJ, Hochman JS, O’Brien SM, Reynolds HR, Boden WE, Stone GW, Bangalore S, Spertus JA, Mark DB, Alexander KP, et al.. International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial: rationale and design.Am Heart J. 2018; 201:124–135. doi: 10.1016/j.ahj.2018.04.011CrossrefMedlineGoogle Scholar14. Maron DJ, Hochman JS, Reynolds HR, Bangalore S, O’Brien SM, Boden WE, Chaitman BR, Senior R, López-Sendón J, Alexander KP, et al.; ISCHEMIA Research Group. Initial invasive or conservative strategy for stable coronary disease.N Engl J Med. 2020; 382:1395–1407. doi: 10.1056/NEJMoa1915922CrossrefMedlineGoogle Scholar15. Stone GW, Hochman JS, Williams DO, Boden WE, Ferguson TB, Harrington RA, Maron DJ. Medical therapy with versus without revascularization in stable patients with moderate and severe ischemia: the case for community equipoise.J Am Coll Cardiol. 2016; 67:81–99. doi: 10.1016/j.jacc.2015.09.056CrossrefMedlineGoogle Scholar16. Rajkumar CA, Nijjer SS, Cole GD, Al-Lamee R, Francis DP. ‘Faith Healing’ and ‘Subtraction Anxiety’ in unblinded trials of procedures: lessons from DEFER and FAME-2 for end points in the ISCHEMIA Trial.Circ Cardiovasc Qual Outcomes. 2018; 11:e004665. doi: 10.1161/CIRCOUTCOMES.118.004665LinkGoogle Scholar17. Spertus JA, Jones PG, Maron DJ, O’Brien SM, Reynolds HR, Rosenberg Y, Stone GW, Harrell FE, Boden WE, Weintraub WS, et al.; ISCHEMIA Research Group. Health-status outcomes with invasive or conservative care in coronary disease.N Engl J Med. 2020; 382:1408–1419. doi: 10.1056/NEJMoa1916370CrossrefMedlineGoogle Scholar18. Spertus JA, Winder JA, Dewhurst TA, Deyo RA, Prodzinski J, McDonell M, Fihn SD. Development and evaluation of the Seattle Angina Questionnaire: a new functional status measure for coronary artery disease.J Am Coll Cardiol. 1995; 25:333–341. doi: 10.1016/0735-1097(94)00397-9CrossrefMedlineGoogle Scholar19. Daly CA, De Stavola B, Sendon JL, Tavazzi L, Boersma E, Clemens F, Danchin N, Delahaye F, Gitt A, Julian D, et al.; Euro Heart Survey Investigators. Predicting prognosis in stable angina–results from the Euro heart survey of stable angina: prospective observational study.BMJ. 2006; 332:262–267. doi: 10.1136/bmj.38695.605440.AECrossrefMedlineGoogle Scholar20. Petrie MC, Jhund PS, She L, Adlbrecht C, Doenst T, Panza JA, Hill JA, Lee KL, Rouleau JL, Prior DL, et al.; STICH Trial Investigators. Ten-year outcomes after coronary artery bypass grafting according to age in patients with heart failure and left ventricular systolic dysfunction: an analysis of the extended follow-up of the STICH Trial (Surgical Treatment for Ischemic Heart Failure).Circulation. 2016; 134:1314–1324. doi: 10.1161/CIRCULATIONAHA.116.024800LinkGoogle Scholar21. Al-Lamee RK, Shun-Shin MJ, Howard JP, Nowbar AN, Rajkumar C, Thompson D, Sen S, Nijjer S, Petraco R, Davies J, et al.. Dobutamine stress echocardiography ischemia as a predictor of the placebo-controlled efficacy of percutaneous coronary intervention in stable coronary artery disease: the stress echocardiography-stratified analysis of ORBITA.Circulation. 2019; 140:1971–1980. doi: 10.1161/CIRCULATIONAHA.119.042918LinkGoogle Scholar22. Douglas PS, Hoffmann U, Patel MR, Mark DB, Al-Khalidi HR, Cavanaugh B, Cole J, Dolor RJ, Fordyce CB, Huang M, et al.; PROMISE Investigators. Outcomes of anatomical versus functional testing for coronary artery disease.N Engl J Med. 2015; 372:1291–1300. doi: 10.1056/NEJMoa1415516CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsRelated articlesMyocardial Ischemia in the Management of Chronic Coronary Artery DiseaseRaymond J. Gibbons,Circulation: Cardiovascular Imaging. 2021;14 January 2021Vol 14, Issue 1Article InformationMetrics Download: 233 © 2021 American Heart Association, Inc.https://doi.org/10.1161/CIRCIMAGING.120.012319PMID: 33455407 Originally publishedJanuary 18, 2021 Keywordsmyocardial ischemiacomputed tomographic angiographyleft ventricular functionEditorialsischemiaangiographyPDF download SubjectsNuclear Cardiology and PETComputerized Tomography (CT)ImagingMagnetic Resonance Imaging (MRI)
Background: To risk stratify patients undergoing single-photon emission computed tomography myocardial perfusion imaging (SPECT-MPI) in accordance with appropriate use criteria for referral to coronary angiography, we developed a risk classification algorithm incorporating appropriate use criteria–defined risk features. We evaluated the association between this algorithm with downstream angiography, revascularization, and all-cause mortality. Methods: We studied consecutive patients who underwent SPECT-MPI from January 1, 2015, to December 31, 2017, and assigned a scan risk of low, intermediate, high, or indeterminate. With this stratification, we assessed referral for angiography and revascularization within 3 months of SPECT-MPI and intermediate-term mortality. Results: Among 12 799 patients, the mean age was 66 years, and a majority were men (56.8%). Most patients were low risk (83.6%) followed by intermediate (9.9%) and high risk (5.2%). Compared with low-risk patients, intermediate- and high-risk patients were more frequently referred for angiography (14.8% and 13.6% versus 2.0%; P <0.001) and revascularization (7.7% and 6.8% versus 0.7%; P <0.001). In 1008 propensity-matched patients, scan risk was independently associated with angiography after adjustment for ischemia, scar, or stress ejection fraction. At a mean follow-up of 2.3 years, mortality was higher with increased scan risk (high, 10.4%; intermediate, 7.1%; low, 4.1%; P <0.001). Compared with low scan risk, intermediate (hazard ratio, 1.37 [95% CI, 1.09–1.72]; P =0.008) and high scan risk (hazard ratio, 1.98 [95% CI, 1.53–2.56]; P <0.001) were associated with mortality in multivariable analysis. Similar findings were observed for those undergoing pharmacological and exercise SPECT-MPI with comparatively worse prognosis among pharmacological patients. Conclusions: This appropriate use criteria–derived risk classification algorithm for SPECT-MPI guided referral for coronary angiography and revascularization and was significantly associated with mortality. This algorithm may serve as an important tool to reaffirm appropriate use criteria and direct management of patients with stable ischemic heart disease undergoing stress testing.
The 2017 European Society of Cardiology (ESC) valvular heart disease guidelines includes gender specific computed tomography (CT) calcium scores within an algorithm to adjudicate severity of low-flow, low-gradient aortic stenosis (AS). It is estimated that at least 10-15% of patients with low-flow,
A 58-year-old man with a history of hypertension and psoriasis presented with acute-onset heart failure with an ejection fraction of 25%-30%. During the work-up, cardiac magnetic resonance imaging showed a pattern of inflammation consistent with sarcoidosis, which was confirmed with (18)F-fluorodeoxyglucose positron emission tomography . The patient was recently initiated on ixekizumab for psoriasis, which was then discontinued. This discontinuation resulted in complete resolution of cardiac sarcoidosis, with establishment of normal ejection fraction. This result suggests a potential causal association of ixekizumab-induced cardiac sarcoidosis, which is a rare phenomenon. Elucidation of the mechanism behind the effect of ixekizumab may provide insights into the possible mechanism(s) behind cardiac sarcoidosis.
Vasodilator stress cardiac magnetic resonance (CMR) offers superior accuracy over single-photon emission computed tomography (SPECT) ([1][1]); however, pharmacological stress cannot reproduce exertional symptoms or signs. We have shown that MR-compatible treadmill stress with CMR offers excellent
Background: To risk stratify patients undergoing SPECT-MPI in accordance with AUC for referral of angiography and revascularization, we developed a novel risk classification scheme incorporating AU...
myocardial perfusion imaging; SPECT; cardiac magnetic resonance; exercise stress Vasodilator stress CMR offers superior accuracy over SPECT(1); however, pharmacological stress cannot reproduce exertional symptoms or signs.We have shown that MR-compatible treadmill stress with CMR offers excellent diagnostic performance vs. SPECT(2).Here, we compared exercise CMR and SPECT costs for ischemic heart disease (IHD) evaluation in a randomized trial (NCT01875315).Adults referred for treadmill stress SPECT were enrolled across 4 centers: men age ≥30 years with chest pain/equivalents, diabetic women age >30 years and all women age ≥40 years with chest pain/equivalents, and individuals with known CAD.Excluded were those with contraindication to CMR or exercise stress(3).Subjects provided written informed consent to participate in this protocol approved across research committees.Subjects randomized to SPECT underwent rest MPI followed by standard Bruce protocol stress and stress MPI.Those randomized to stress CMR had rest cines, then standard Bruce protocol stress.Acquisition of free-breathing cine and perfusion imaging commenced
We previously reported how relative regional strain ratio (RRSR) is prognostic in cardiac amyloidosis (CA), with RRSR > 1 (apical sparing strain pattern) as a significant categorical indicator of poor survival. What is unknown is how RRSR changes over time and how this influences survival. 96
OBJECTIVES:The aim of this study was to compare, using results from the multicenter SPINS (Stress CMR Perfusion Imaging in the United States) study, the incremental cost-effectiveness of a stress cardiovascular magnetic resonance (CMR)-first strategy against 4 other clinical strategies for patients with stable symptoms suspicious for myocardial ischemia: 1) immediate x-ray coronary angiography (XCA) with selective fractional flow reserve for all patients; 2) single-photon emission computed tomography; 3) coronary computed tomographic angiography with selective computed tomographic fractional flow reserve; and 4) no imaging. BACKGROUND:Stress CMR perfusion imaging has established excellent diagnostic utility and prognostic value in coronary artery disease (CAD), but its cost-effectiveness in current clinical practice has not been well studied in the United States. METHODS:A decision analytic model was developed to project health care costs and lifetime quality-adjusted life years (QALYs) for symptomatic patients at presentation with a 32.4% prevalence of obstructive CAD. Rates of clinical events, costs, and quality-of-life values were estimated from SPINS and other published research. The analysis was conducted from a U.S. health care system perspective, with health and cost outcomes discounted annually at 3%. RESULTS:Using hard cardiovascular events (cardiovascular death or acute myocardial infarction) as the endpoint, total costs per person were lowest for the no-imaging strategy ($16,936) and highest for the immediate XCA strategy ($20,929). Lifetime QALYs were lowest for the no-imaging strategy (12.72050) and highest for the immediate XCA strategy (12.76535). The incremental cost-effectiveness ratio for the CMR-based strategy compared with the no-imaging strategy was $52,000/QALY, whereas the incremental cost-effectiveness ratio for the immediate XCA strategy was $12 million/QALY compared with CMR. Results were sensitive to variations in model inputs for prevalence of disease, hazard rate ratio for treatment of CAD, and annual discount rate. CONCLUSIONS:Prior to invasive XCA, stress CMR can be a cost-effective gatekeeping tool in patients at risk for obstructive CAD in the United States. (Stress CMR Perfusion Imaging in the United States [SPINS] Study; NCT03192891.