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Transfusion in Ischemic Heart Disease: Correlation, Confounding, and Confusion [Comment]

Rao, Sunil V; Vora, Amit N
PMID: 26653626
ISSN: 1558-3597
CID: 5224512

Simplified Predictive Instrument to Rule Out Acute Coronary Syndromes in a High-Risk Population

Fanaroff, Alexander C; Schulteis, Ryan D; Pieper, Karen S; Rao, Sunil V; Newby, L Kristin
BACKGROUND:It is unclear whether diagnostic protocols based on cardiac markers to identify low-risk chest pain patients suitable for early release from the emergency department can be applied to patients older than 65 years or with traditional cardiac risk factors. METHODS AND RESULTS/RESULTS:In a single-center retrospective study of 231 consecutive patients with high-risk factor burden in which a first cardiac troponin (cTn) level was measured in the emergency department and a second cTn sample was drawn 4 to 14 hours later, we compared the performance of a modified 2-Hour Accelerated Diagnostic Protocol to Assess Patients with Chest Pain Using Contemporary Troponins as the Only Biomarker (ADAPT) rule to a new risk classification scheme that identifies patients as low risk if they have no known coronary artery disease, a nonischemic electrocardiogram, and 2 cTn levels below the assay's limit of detection. Demographic and outcome data were abstracted through chart review. The median age of our population was 64 years, and 75% had Thrombosis In Myocardial Infarction risk score ≥2. Using our risk classification rule, 53 (23%) patients were low risk with a negative predictive value for 30-day cardiac events of 98%. Applying a modified ADAPT rule to our cohort, 18 (8%) patients were identified as low risk with a negative predictive value of 100%. In a sensitivity analysis, the negative predictive value of our risk algorithm did not change when we relied only on undetectable baseline cTn and eliminated the second cTn assessment. CONCLUSIONS:If confirmed in prospective studies, this less-restrictive risk classification strategy could be used to safely identify chest pain patients with more traditional cardiac risk factors for early emergency department release.
PMCID:4845272
PMID: 26667086
ISSN: 2047-9980
CID: 5224522

Collaborative quality improvement vs public reporting for percutaneous coronary intervention: A comparison of percutaneous coronary intervention in New York vs Michigan

Boyden, Thomas F; Joynt, Karen E; McCoy, Lisa; Neely, Megan L; Cavender, Matthew A; Dixon, Simon; Masoudi, Frederick A; Peterson, Eric; Rao, Sunil V; Gurm, Hitinder S
INTRODUCTION/BACKGROUND:Public reporting (PR) is a policy mechanism that may improve clinical outcomes for percutaneous coronary intervention (PCI). However, prior studies have shown that PR may have an adverse impact on patient selection. It is unclear whether alternatives to PR, such as collaborative quality improvement (CQI), may drive improvements in quality of care and outcomes for patients receiving PCI without the unintended consequences seen with PR. METHODS:Using National Cardiovascular Data Registry CathPCI Registry data from January 2011 through September 2012, we evaluated patients who underwent PCI in New York (NY), a state with PR (N = 51,983), to Michigan, a state with CQI (N = 53,528). We compared patient characteristics, the quality of care delivered, and clinical outcomes. RESULTS:Patients undergoing PCI in NY had a lower-risk profile, with a lower proportion of patients with ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, or cardiogenic shock, compared with Michigan. Quality of care was broadly similar in the 2 states; however, outcomes were better in NY. In a propensity-matched analysis, patients in NY were less likely to be referred for emergent, urgent, or salvage coronary artery bypass surgery (odds ratio [OR] 0.67, 95% CI 0.51-0.88, P < .0001) and to receive blood transfusion (OR 0.7, 95% CI 0.61-0.82, P < .0001), and had lower in-hospital mortality (OR 0.72, 95% CI 0.63-0.83, P < .0001). CONCLUSIONS:Public reporting of PCI data is associated with fewer high-risk patients undergoing PCI compared with CQI. However, in comparable samples of patients, PR is also associated with a lower risk of mortality and adverse events. The optimal quality improvement method may involve combining these 2 strategies to protect access to care while still driving improvements in patient outcomes.
PMCID:6948714
PMID: 26678645
ISSN: 1097-6744
CID: 5224532

Transradial Versus Transfemoral Access in Patients Undergoing Rescue Percutaneous Coronary Intervention After Fibrinolytic Therapy

Kadakia, Mitul B; Rao, Sunil V; McCoy, Lisa; Choudhuri, Paramita S; Sherwood, Matthew W; Lilly, Scott; Kobayashi, Taisei; Kolansky, Daniel M; Wilensky, Robert L; Yeh, Robert W; Giri, Jay
OBJECTIVES/OBJECTIVE:The purpose of this study was to assess usage patterns of transradial access in rescue percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) and associations between vascular access site choice and outcomes. BACKGROUND:Transradial access reduces bleeding and mortality in STEMI patients undergoing primary PCI. Little is known about access site choice and outcomes in patients undergoing rescue PCI after receiving full-dose fibrinolytic therapy for STEMI. METHODS:Patients in the National Cardiovascular Data Registry's CathPCI Registry undergoing rescue PCI for STEMI between 2009 and 2013 were studied. Patients were divided on the basis of access site. Patterns of access use and baseline demographics were noted. Unadjusted and propensity-matched analyses were performed comparing in-hospital bleeding, vascular complications, and mortality outcomes among transradial and transfemoral access patients. The falsification endpoint of gastrointestinal bleeding was specified to assess for persistent unmeasured confounding. RESULTS:Transradial access was used in 14.2% of cases. In propensity-matched analyses, transradial rescue PCI was associated with significantly less bleeding than transfemoral access (odds ratio [OR]: 0.67; 95% confidence interval [CI]: 0.52 to 0.87; p = 0.003), but not mortality (OR: 0.81; 95% CI: 0.53 to 1.25; p = 0.35). Gastrointestinal bleeding was less frequent in the radial group (OR: 0.23; 95% CI: 0.05 to 0.98; p = 0.05). CONCLUSIONS:In a large, "real-world" registry, transradial access was used in a minority of cases and was associated with significantly less bleeding than transfemoral access in patients undergoing rescue PCI. However, given persistent differences in a falsification endpoint, the influence of treatment-selection bias on these results cannot be ruled out. Further studies are needed to determine predictors of bleeding and mortality in this understudied high-risk group.
PMID: 26718516
ISSN: 1876-7605
CID: 5224572

Radial Approach: Fundamental Techniques and Evidence [Editorial]

Rao, Sunil V
PMID: 28582056
ISSN: 2211-7466
CID: 5225172

Radiation exposure in relation to the arterial access site used for diagnostic coronary angiography and percutaneous coronary intervention: a systematic review and meta-analysis

Plourde, Guillaume; Pancholy, Samir B; Nolan, Jim; Jolly, Sanjit; Rao, Sunil V; Amhed, Imdad; Bangalore, Sripal; Patel, Tejas; Dahm, Johannes B; Bertrand, Olivier F
BACKGROUND: Transradial access for cardiac catheterisation results in lower bleeding and vascular complications than the traditional transfemoral access route. However, the increased radiation exposure potentially associated with transradial access is a possible drawback of this method. Whether transradial access is associated with a clinically significant increase in radiation exposure that outweighs its benefits is unclear. Our aim was therefore to compare radiation exposure between transradial access and transfemoral access for diagnostic coronary angiograms and percutaneous coronary interventions (PCI). METHODS: We did a systematic review and meta-analysis of the scientific literature by searching the PubMed, Embase, and Cochrane Library databases with relevant terms, and cross-referencing relevant articles for randomised controlled trials (RCTs) that compared radiation parameters in relation to access site, published from Jan 1, 1989, to June 3, 2014. Three investigators independently sorted the potentially relevant studies, and two others extracted data. We focused on the primary radiation outcomes of fluoroscopy time and kerma-area product, and used meta-regression to assess the changes over time. Secondary outcomes were operator radiation exposure and procedural time. We used both fixed-effects and random-effects models with inverse variance weighting for the main analyses, and we did confirmatory analyses for observational studies. FINDINGS: Of 1252 records identified, we obtained data from 24 published RCTs for 19 328 patients. Our primary analyses showed that transradial access was associated with a small but significant increase in fluoroscopy time for diagnostic coronary angiograms (weighted mean difference [WMD], fixed effect: 1.04 min, 95% CI 0.84-1.24; p<0.0001) and PCI (1.15 min, 95% CI 0.96-1.33; p<0.0001), compared with transfemoral access. Transradial access was also associated with higher kerma-area product for diagnostic coronary angiograms (WMD, fixed effect: 1.72 Gy.cm2, 95% CI -0.10 to 3.55; p=0.06), and significantly higher kerma-area product for PCI (0.55 Gy.cm2, 95% CI 0.08-1.02; p=0.02). Mean operator radiation doses for PCI with basic protection were 107 muSv (SD 110) with transradial access and 74 muSv (68) with transfemoral access; with supplementary protection, the doses decreased to 21 muSv (17) with transradial access and 46 muSv (9) with transfemoral. Meta-regression analysis showed that the overall difference in fluoroscopy time between the two procedures has decreased significantly by 75% over the past 20 years from 2 min in 1996 to about 30 s in 2014 (p<0.0001). In observational studies, differences and effect sizes remained consistent with RCTs. INTERPRETATION: Transradial access was associated with a small but significant increase in radiation exposure in both diagnostic and interventional procedures compared with transfemoral access. Since differences in radiation exposure narrow over time, the clinical significance of this small increase is uncertain and is unlikely to outweigh the clinical benefits of transradial access. FUNDING: None.
PMID: 26411986
ISSN: 1474-547x
CID: 1789692

Comparison of quality-of-life measures after radial versus femoral artery access for cardiac catheterization in women: Results of the Study of Access Site for Enhancement of Percutaneous Coronary Intervention for Women quality-of-life substudy

Hess, Connie N; Krucoff, Mitchell W; Sheng, Shubin; Anstrom, Kevin J; Barham, W Britt; Gilchrist, Ian C; Harrington, Robert A; Jacobs, Alice K; Mehran, Roxana; Messenger, John C; Mark, Daniel B; Rao, Sunil V
BACKGROUND: In the SAFE-PCI for Women trial, patient preference for radial access for future procedures was greater than for femoral access. We sought to assess whether radial or femoral access impacts formal measures of quality-of-life (QOL) among women undergoing cardiac catheterization. METHODS: We assessed QOL using European quality of life-5 dimensions (EQ-5D) and EQ visual analog scale (EQ-VAS) scores among 304 women randomized to radial or femoral arteriotomy in the SAFE-PCI for Women trial at sites with QOL substudy approval. Patient surveys were administered at baseline, hospital discharge, and 30 days (for percutaneous coronary intervention patients). RESULTS: Women randomized to both treatments had similar EQ-5D index and EQ-VAS scores at baseline, hospital discharge, and 30-day follow-up. After adjustment for baseline scores, there was no effect of assigned treatment on EQ-5D (discharge 0.004; 95% CI -0.03 to 0.04; 30 days -0.03; 95% CI -0.09 to 0.02) or EQ-VAS (discharge -1.31; 95% CI -4.74 to 2.12; 30 days -2.10; 95% CI -8.92 to 4.71) scores. At discharge, 60.5% versus 63.5% (P = .60) of patients in radial and femoral groups were free from access site pain; at 30 days, rates were 85.7% versus 77.6% (P = .30), respectively. Patient preference for the same access strategy for repeat procedures was greater in the radial versus femoral group (77.2% vs 26.8%; P < .0001). CONCLUSIONS: Using established QOL instruments, we did not measure any difference in QOL or functional status according to access site strategy in women undergoing cardiac catheterization, yet patient preference for the radial approach was significantly greater. Other factors influencing patient choice for radial access should be investigated.
PMID: 26299236
ISSN: 1097-6744
CID: 1762842

Elinogrel

Chapter by: Chung, Matthew J.; Rao, Sunil V.
in: ANTIPLATELET THERAPY IN CARDIOVASCULAR DISEASE by
pp. 173-179
ISBN: 978-1-118-49398-4
CID: 5227422

The current state of medical simulation in interventional cardiology: a clinical document from the Society for Cardiovascular Angiography and Intervention's (SCAI) Simulation Committee

Green, Sandy M; Klein, Andrew J; Pancholy, Samir; Rao, Sunil V; Steinberg, Daniel; Lipner, Rebecca; Marshall, Jeffery; Messenger, John C
OBJECTIVES/OBJECTIVE:To assess the current use and application of simulators in interventional cardiology. BACKGROUND:Despite a paucity of data on the efficacy of simulation in medicine, cardiovascular simulation training is now a mandated part of cardiovascular fellowship training. Additionally, simulators have been endorsed by the Food and Drug Administration as a way to teach physicians new and novel procedures. We sought to establish the current use of simulators in cardiovascular medicine. METHODS:A systematic review was done of available training programs, and currently existing data regarding simulation training. A panel of experts was convened to review this data and provide recommendations as how simulation should be used in the field of interventional cardiology. RESULTS:This document provides a comprehensive review of the current state of simulation and how we as a society must formulate well validated studies to more closely examine and explore how this technology can be further studied and validated. CONCLUSIONS:Simulation will likely take on a larger role in cardiovascular training and maintenance of certification, but at the current time lacks a large body of evidence for its use.
PMID: 23737458
ISSN: 1522-726x
CID: 5223722

Anticoagulation in transradial percutaneous coronary intervention

Appleton, Darryn L; Cooke, Richard H; Rao, Sunil V; Jovin, Ion S
Transradial percutaneous coronary intervention (PCI) is associated with significant reductions in access site complications and major bleeding as compared with the transfemoral approach. Bivalirudin is now the most commonly used anticoagulant for transradial PCI in the United States, while weight adjusted unfractionated heparin remains the most common choice outside the United States. A growing number of reports suggest that transradial intervention may offer improved outcomes across a variety of clinical situations, including those at the highest risk of bleeding complications, such as those with acute myocardial infarction. The following review provides an overview of the studies evaluating anticoagulation in transradial PCI and a rationale for the combination of the transradial approach to coronary interventions with an optimal anticoagulant strategy to reduce both access site and nonaccess site-related bleeding.
PMID: 23766092
ISSN: 1522-726x
CID: 5223752