manesh patel

Non-invasive assessment of stable chest pain patients is a critical determinant of resource utilization and clinical outcomes. Increasingly coronary computed tomography angiography (CCTA) with selective CCTA-derived fractional flow reserve (FFRCT) is being used. The ADVANCE Registry, is a large prospective examination of using a CCTA and FFRCT diagnostic pathway in real-world settings, with the aim of determining the impact of this pathway on decision-making, downstream invasive coronary angiography (ICA), revascularization, and major adverse cardiovascular events (MACE). A total of 5083 patients with symptoms concerning for coronary artery disease (CAD) and atherosclerosis on CCTA were enrolled at 38 international sites from 15 July 2015 to 20 October 2017. Demographics, symptom status, CCTA and FFRCT findings, treatment plans, and 90 days outcomes were recorded. The primary endpoint of reclassification between core lab CCTA alone and CCTA plus FFRCT-based management plans occurred...

The aim of this study was to investigate the clinical outcomes of patients deferred from coronary revascularization on the basis of instantaneous wave-free ratio (iFR) or fractional flow reserve (FFR) measurements in stable angina pectoris (SAP) and acute coronary syndromes (ACS). Assessment of coronary stenosis severity with pressure guidewires is recommended to determine the need for myocardial revascularization. The safety of deferral of coronary revascularization in the pooled per-protocol population (n = 4,486) of the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation) and iFR-SWEDEHEART (Instantaneous Wave-Free Ratio Versus Fractional Flow Reserve in Patients With Stable Angina Pectoris or Acute Coronary Syndrome) randomized clinical trials was investigated. Patients were stratified according to revascularization decision making on the basis of iFR or FFR and to clinical presentation (SAP or ACS). The primary endpoint was major adver...

Purpose To assess concordance and relative prognostic utility between central core laboratory and local site interpretation for significant coronary artery disease (CAD) and cardiovascular events. Materials and Methods In the Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) trial, readers at 193 North American sites interpreted coronary computed tomographic (CT) angiography as part of the clinical evaluation of stable chest pain. Readers at a central core laboratory also interpreted CT angiography blinded to clinical data, site interpretation, and outcomes. Significant CAD was defined as stenosis greater than or equal to 50%; cardiovascular events were defined as a composite of cardiovascular death or myocardial infarction. Results In 4347 patients (51.8% women; mean age ± standard deviation, 60.4 years ± 8.2), core laboratory and site interpretations were discordant in 16% (683 of 4347), most commonly because of a finding of significant CAD by site but n...

Background— Morbidity and mortality conference is a common educational and quality improvement activity performed in cardiac catheterization laboratories, but best practices for case selection and for maximizing the effectiveness of peer review have not been determined. Methods and Results— We reviewed the 10-year percutaneous coronary intervention morbidity and mortality conference experience of an academic medical center. Cases were triggered for review by the occurrence of prespecified procedural events. Summary reports from morbidity and mortality conference discussions were linked to clinical data from the Duke Databank for Cardiovascular Disease to compare baseline and procedural characteristics and to assess postdischarge outcomes. Of 11 786 procedures, from 2004 to 2013, 157 (1.3%) were triggered for review. The most frequent triggering events were cardioversion/defibrillation (72, 0.6%), unplanned use of mechanical circulatory support (64, 0.5%), and major dissection (41, 0...

The American College of Cardiology, Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, and American Association for Thoracic Surgery, along with key specialty and subspecialty societies, have completed a 2-part revision of the appropriate use criteria (AUC) for coronary revascularization. In prior coronary revascularization AUC documents, indications for revascularization in acute coronary syndromes (ACS) and stable ischemic heart disease were combined into 1 document. To address the expanding clinical indications for coronary revascularization, and in an effort to align the subject matter with the most current American College of Cardiology/American Heart Association guidelines, the new AUC for coronary artery revascularization were separated into 2 documents addressing ACS and stable ischemic heart disease individually. This document presents the AUC for ACS. Clinical scenarios were developed to mimic patient presentations encountered in everyday practice and included information on symptom status, presence of clinical instability or ongoing ischemic symptoms, prior reperfusion therapy, risk level as assessed by noninvasive testing, fractional flow reserve testing, and coronary anatomy. This update provides a reassessment of clinical scenarios that the writing group felt to be affected by significant changes in the medical literature or gaps from prior criteria. The methodology used in this update is similar to the initial document but employs the recent modifications in the methods for developing AUC, most notably, alterations in the nomenclature for appropriate use categorization. A separate, independent rating panel scored the clinical scenarios on a scale of 1 to 9. Scores of 7 to 9 indicate that revascularization is considered appropriate for the clinical scenario presented. Scores of 1 to 3 indicate that revascularization is considered rarely appropriate for the clinical scenario, whereas scores in the mid-range (4 to 6) indicate that coronary revascularization may be appropriate for the clinical scenario. Seventeen clinical scenarios were developed by a writing committee and scored by the rating panel: 10 were identified as appropriate, 6 as may be appropriate, and 1 as rarely appropriate. As seen with the prior coronary revascularization AUC, revascularization in clinical scenarios with ST-segment elevation myocardial infarction and non–ST-segment elevation myocardial infarction were considered appropriate. Likewise, clinical scenarios with unstable angina and intermediate- or high-risk features were deemed appropriate. Additionally, the management of nonculprit artery disease and the timing of revascularization are now also rated. The primary objective of the AUC is to provide a framework for the assessment of practice patterns that will hopefully improve physician decision making.

Coronary computed tomographic angiography (CTA) plus estimation of fractional flow reserve using CTA (FFRCT) safely and effectively guides initial care over 90 days in patients with stable chest pain. Longer-term outcomes are unknown. The study sought to determine the 1-year clinical, economic, and quality-of-life (QOL) outcomes of using FFRCT instead of usual care. Consecutive patients with stable, new onset chest pain were managed by either usual testing (n = 287) or CTA (n = 297) with selective FFRCT (submitted in 201, analyzed in 177); 581 of 584 (99.5%) completed 1-year follow-up. Endpoints were adjudicated major adverse cardiac events (MACE) (death, myocardial infarction, unplanned revascularization), total medical costs, and QOL. Patients averaged 61 years of age with a mean 49% pre-test probability of coronary artery disease. At 1 year, MACE events were infrequent, with 2 in each arm of the planned invasive group and 1 in the planned noninvasive cohort (usual care strategy)....

Substantial geographic variation exists in percutaneous coronary intervention (PCI) use across the United States. It is unclear the extent to which high PCI utilization can be explained by PCI for inappropriate indications. The objective of this study was to examine the relationship between PCI rates across regional healthcare markets utilizing hospital referral regions (HRRs) and PCI appropriateness. The number of PCI procedures in each HRR was obtained from the 2010 100% Medicare limited data set. HRRs were divided into quintiles of PCI utilization with increasing rates of utilization progressing to quintile 5. NCDR CathPCI Registry® data were used to evaluate patient characteristics, appropriate use criteria (AUC), and outcomes across the HRR quintiles defined by PCI utilization with the study population restricted to HRRs where ≥ 80% of the PCIs were performed at institutions participating in the registry. PCI appropriateness was defined using 2012 AUC by the American College of...

The first Appropriate Use Criteria (AUC) for coronary revascularization was published in 2009 with an update published in 2012(1,2). A new version of the AUC for coronary revascularization is currently under development and will hopefully address some of the constructive criticisms directed at the earlier versions. The use of AUC is increasing and several other organizations have developed AUC for different procedures outside the cardiovascular arena. For example, orthopedic surgeons now have AUC for several of their common procedures, the American Academy of Dermatology has AUC for Mohs surgery, and recently AUC for placement of Foley catheters was published(3-5). With the increasing development, promotion and adoption of AUC it is reasonable to ask a critical question. What are the effects of AUC on the delivery of cardiovascular care? This is a fair question as the AUC are intended to address the rational use of coronary revascularization, provide a practical standard upon which ...

The optimal treatments to improve functional status and quality of life in patients with intermittent claudication (IC) are unknown. We assessed the comparative effectiveness of supervised exercise, medical therapy, and endovascular or surgical revascularization in patients with IC. Two

Atherosclerosis is a systemic vascular disorder, involving multiple arterial territories. This project sought to investigate the relationship between lower extremity peripheral artery disease (PAD) and carotid artery stenosis (CAS) in a large self-referred population. Data from the ankle brachial index (ABI) and carotid duplex ultrasound were analyzed from 3.67 million US subjects in the Life Line Screening program between 2004 and 2008. PAD was defined by ABI<0.9 and CAS was defined by greater than 50% stenosis. Multivariate logistic regression analysis was used to estimate odds of CAS by PAD status and severity. Mean age of the population was 63.7 ± 10.6 years and 64% were women. The prevalence of PAD and CAS was 4.1% and 3.9%, respectively. Subjects with PAD had a higher prevalence of CAS than those without PAD (18.8% vs. 3.3%, P < 0.0001). In multivariate analysis, PAD was associated with greater odds of CAS (OR 3.28, 95% CI 3.22-3.34). Both symptomatic (OR 3.66, 95% CI 3....

Cardiac magnetic resonance imaging is an attractive noninvasive metric and has genuine potential to constitute a reliable surrogate end point in ST-elevation myocardial infarction. However, these measures must be demonstrated as a valid proxy to predict clinical outcome. In conclusion, the current review evaluates the utility of cardiac magnetic resonance as a surrogate measurement of myocardial infarct size, left ventricular function, microvascular obstruction, and myocardial salvage in ST-elevation myocardial infarction exploring the temporal relations specific to each assessment.

No consistent differential effects were observed for other outcomes (few studies reported long-term outcomes), including death, car- diovascular events, quality of life, rate of single antihypertensive agent use, lipid levels, progression to diabetes, left ventricular mass or function, and kidney disease. Consistent fair- to good-quality evidence showed that ACE inhibitors were associated with a greater risk for cough. There were

Peripheral vascular intervention (PVI) is an effective treatment option for patients with peripheral artery disease (PAD). In 2008, Medicare modified reimbursement rates to encourage more efficient outpatient use of PVI in the United States. The purpose of this study was to evaluate trends in the use and clinical settings of PVI and the effect of changes in reimbursement. Using a 5% national sample of Medicare fee-for-service beneficiaries from 2006 to 2011, we examined age- and sex-adjusted rates of PVI by year, type of procedure, clinical setting, and physician specialty. A total of 39,339 Medicare beneficiaries underwent revascularization for PAD between 2006 and 2011. The annual rate of PVI increased slightly from 401.4 to 419.6 per 100,000 Medicare beneficiaries (p = 0.17), but the clinical setting shifted. The rate of PVI declined in inpatient settings from 209.7 to 151.6 (p < 0.001), whereas the rate expanded in outpatient hospitals (184.7 to 228.5; p = 0.01) and office-ba...

No consistent differential effects were observed for other outcomes (few studies reported long-term outcomes), including death, car- diovascular events, quality of life, rate of single antihypertensive agent use, lipid levels, progression to diabetes, left ventricular mass or function, and kidney disease. Consistent fair- to good-quality evidence showed that ACE inhibitors were associated with a greater risk for cough. There were

Anticoagulation prophylaxis for stroke is recommended for at-risk patients with either persistent or paroxysmal atrial fibrillation (AF). We compared outcomes in patients with persistent vs. paroxysmal AF receiving oral anticoagulation. Patients randomized in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET-AF) trial (n = 14 264) were grouped by baseline AF category: paroxysmal or persistent. Multivariable adjustment was performed to compare thrombo-embolic events, bleeding, and death between groups, in high-risk subgroups, and across treatment assignment (rivaroxaban or warfarin). Of 14 062 patients, 11 548 (82%) had persistent AF and 2514 (18%) had paroxysmal AF. Patients with persistent AF were marginally older (73 vs. 72, P = 0.03), less likely female (39 vs. 45%, P < 0.0001), and more likely to have previously used vitamin K antagonists (64 vs. 56%, P <...

This study sought to investigate the long-term effectiveness of drug-eluting stents (DES) versus bare-metal stents (BMS). Improved recanalization techniques have increased interest in percutaneous coronary intervention (PCI) for chronic total coronary occlusion (CTO). The long-term effectiveness of DES and BMS is not known. We used data from 10,261 stable patients age ≥65 years at 889 U.S. hospitals who underwent CTO PCI from January 1, 2005, to December 31, 2008, in the NCDR (National Cardiovascular Data Registry) CathPCI Registry with linked Medicare inpatient claims for follow-up. Patient and procedural characteristics, and 30-month death, myocardial infarction, revascularization, and hospitalization for bleeding were evaluated by stent type. Outcomes following stenting were adjusted and compared using propensity score matching. DES were used for CTO PCI in 8,218 (80%) and BMS in 2,043 (20%). DES patients were younger (74.0 vs. 75.5 years, p < 0.001), had longer lesions (18.8 vs. 16.5 mm, p < 0.001), received more stents (≥2 stents in 45.7% vs. 37.9%, p < 0.001), and underwent multivessel PCI (18.9% vs. 15.1%, p < 0.001). DES implantation was associated with a lower hazard of mortality (hazard ratio [HR]: = 0.72, 95% confidence interval [CI]: 0.60 to 0.86, p < 0.001), a similar hazard for myocardial infarction (HR: 0.85, 95% CI: 0.61 to 1.19, p = 0.35), and subsequent revascularization (HR: 0.94, 95% CI: 0.79 to 1.12, p = 0.48), including PCI (HR: 0.98, 95% CI: 0.83 to 1.19, p = 0.87) and coronary artery bypass grafting (HR: 0.71, 95% CI: 0.46 to 1.10, p = 0.12). Hospitalization for bleeding was also similar for DES versus BMS (HR: 0.92; 95% CI: 0.61 to 1.39, p = 0.70). Compared with BMS, DES use in stable patients undergoing CTO PCI was associated with lower mortality, as well as similar myocardial infarction and repeat revascularization rates without an increase in subsequent bleeding requiring hospitalization.

In the ROCKET AF (Rivaroxaban-Once-daily, oral, direct Factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation) trial, marked regional differences in control of warfarin anticoagulation, measured as the average individual patient time in the therapeutic range (iTTR) of the international normalized ratio (INR), were associated with longer inter-INR test intervals. The standard Rosendaal approach can produce biased low estimates of TTR after an appropriate dose change if the follow-up INR test interval is prolonged. We explored the effect of alternative calculations of TTR that more immediately account for dose changes on regional differences in mean iTTR in the ROCKET AF trial. We used an INR imputation method that accounts for dose change. We compared group mean iTTR values between our dose change-based method with the standard Rosendaal method and determined that the differences between approaches depended on the ba...

We investigated clinical characteristics and outcomes of patients with significant valvular disease (SVD) in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) trial. ROCKET AF excluded patients with mitral stenosis or artificial valve prostheses. We used Cox regression to adjust comparisons for potential confounders. Among 14 171 patients, 2003 (14.1%) had SVD; they were older and had more comorbidities than patients without SVD. The rate of stroke or systemic embolism with rivaroxaban vs. warfarin was consistent among patients with SVD [2.01 vs. 2.43%; hazard ratio (HR) 0.83, 95% confidence interval (CI) 0.55-1.27] and without SVD (1.96 vs. 2.22%; HR 0.89, 95% CI 0.75-1.07; interaction P = 0.76). However, rates of major and non-major clinically relevant bleeding with rivaroxaban vs. warfarin were higher in patients with SVD (19.8% rivaroxaban vs. 16.8% warfari...

Diagnostic coronary angiography in asymptomatic patients may lead to inappropriate percutaneous coronary intervention (PCI) due to a diagnostic-therapeutic cascade. Understanding the association between patient selection for coronary angiography and PCI appropriateness may inform strategies to minimize inappropriate procedures. To determine if hospitals that frequently perform coronary angiography in asymptomatic patients, a clinical scenario in which the benefit of angiography is less clear, are more likely to perform inappropriate PCI. Multicenter observational study of 544 hospitals participating in the CathPCI Registry between July 1, 2009, and September 30, 2013. Hospital proportion of asymptomatic patients at diagnostic coronary angiography and hospital rate of inappropriate PCI as defined by 2012 appropriate use criteria for coronary revascularization. Of 1 225 562 patients who underwent elective coronary angiography, 308 083 (25.1%) were asymptomatic. The hospital proportion...

Lower extremity peripheral artery disease (PAD) has been proposed as a 'coronary heart disease (CHD) risk equivalent'. We aimed to examine whether PAD confers similar risk for mortality as incident myocardial infarction (MI) and whether risk differs by gender. Using nationwide Danish administrative registries (2000-2008), we identified patients aged ≥40 years with incident PAD (PAD only, n = 35,628), incident PAD with a history of MI (PAD + MI, n = 7029), and incident MI alone (MI alone, n = 71,115). Patients with PAD only tended to be younger, female, and have less comorbidity than the other groups. During follow up (median 1051 d, IQR 384-1938), we found that MI-alone patients had greater risk of adverse outcomes in the acute setting (first 90 d); however, the PAD-only and PAD + MI groups had higher long-term mortality at 7 years than those with MI alone (47.8 and 60.4 vs. 36.4%, respectively; p < 0.0001). After adjustment, the PAD-only and PAD + MI groups had a higher ...

Nonvalvular atrial fibrillation is common in elderly patients, who face an elevated risk of stroke but difficulty sustaining warfarin treatment. The oral factor Xa inhibitor rivaroxaban was noninferior to warfarin in the Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF). This prespecified secondary analysis compares outcomes in older and younger patients. There were 6229 patients (44%) aged ≥75 years with atrial fibrillation and ≥2 stroke risk factors randomized to warfarin (target international normalized ratio=2.0-3.0) or rivaroxaban (20 mg daily; 15 mg if creatinine clearance <50 mL/min), double blind. The primary end point was stroke and systemic embolism by intention to treat. Over 10 866 patient-years, older participants had more primary events (2.57% versus 2.05%/100 patient-years; P=0.0068) and major bleeding (4.63% versus 2.74%/100 patient-years; P<0.0001). Stroke/systemic embolism rates were consistent among older (2.29% rivaroxaban versus 2.85% warfarin per 100 patient-years; hazard ratio=0.80; 95% confidence interval, 0.63-1.02) and younger patients (2.00% versus 2.10%/100 patient-years; hazard ratio=0.95; 95% confidence interval, 0.76-1.19; interaction P=0.313), as were major bleeding rates (≥75 years: 4.86% rivaroxaban versus 4.40% warfarin per 100 patient-years; hazard ratio=1.11; 95% confidence interval, 0.92-1.34; <75 years: 2.69% versus 2.79%/100 patient-years; hazard ratio=0.96; 95% confidence interval, 0.78-1.19; interaction P=0.336). Hemorrhagic stroke rates were similar in both age groups; there was no interaction between age and rivaroxaban response. Elderly patients had higher stroke and major bleeding rates than younger patients, but the efficacy and safety of rivaroxaban relative to warfarin did not differ with age, supporting rivaroxaban as an alternative for the elderly.

The American College of Cardiology Foundation, in collaboration with the Society for Cardiovascular Angiography and Interventions and key specialty and subspecialty societies, conducted a review of common clinical scenarios where diagnostic catheterization is frequently considered. The indications (clinical scenarios) were derived from common applications or anticipated uses, as well as from current clinical practice guidelines and results of studies examining the implementation of noninvasive imaging appropriate use criteria. The 166 indications in this document were developed by a diverse writing group and scored by a separate independent technical panel on a scale of 1 to 9, to designate appropriate use (median 7 to 9), uncertain use (median 4 to 6), and inappropriate use (median 1 to 3). Diagnostic catheterization may include several different procedure components. The indications developed focused primarily on 2 aspects of diagnostic catheterization. Many indications focused on...

Red blood cell transfusion is associated with increased mortality among patients with acute coronary syndromes, but little is known about the consequences of transfusion in a contemporary setting of ST-segment elevation myocardial infarction. We describe the association between transfusion and 90-day mortality among patients with acute myocardial infarction treated with primary percutaneous coronary intervention. Analyses were performed on 5532 patients with ST-elevation myocardial infarction from the Assessment of Pexelizumab in Acute Myocardial Infarction trial. The primary objective of this analysis was to ascertain the relation between red blood cell transfusion and 90-day mortality in patients with recent myocardial infarction. We initially determined the baseline and in-hospital predictors of transfusion (multivariable logistic regressions) and subsequently assessed the association between transfusion and mortality using a series of Cox proportional hazards regression combined to a landmark analyses. A total of 213 patients (3.9%) received a transfusion. Transfusion remained significantly associated with mortality [hazards ratio = 2.16 (1.20-3.88)], despite adjustment for baseline characteristics, in-hospital co-interventions, and for propensity of receiving a transfusion. Among patients who survived to hospital discharge, however, the hazard of death was not different in patients treated with transfusion. Transfusion is associated with 90-day mortality in acute myocardial infarction treated with primary percutaneous coronary intervention. Although transfusion may be causally related to mortality, it is likely that at least part of the association is due to confounding. This association illustrates the complex relationship between transfusion, bleeding, and mortality and underscores the need for further research to understand the relationship between transfusion and clinical outcomes.