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Temporal Trends in Bleeding among Acute Coronary Syndrome Patients: Is It Going Up or Down? Does It Matter? [Comment]

Vora, Amit N; Rao, Sunil V
PMID: 26279286
ISSN: 1421-9751
CID: 5224432

Impact of access site choice on outcomes of patients with cardiogenic shock undergoing percutaneous coronary intervention: A systematic review and meta-analysis

Pancholy, Samir B; Palamaner Subash Shantha, Ghanshyam; Romagnoli, Enrico; Kedev, Sasko; Bernat, Ivo; Rao, Sunil V; Jolly, Sanjit; Bertrand, Olivier F; Patel, Tejas M
BACKGROUND:The benefit of transradial access (TRA) in patients with cardiogenic shock (CS) is uncertain. We sought to determine the benefits of TRA in patients with CS undergoing coronary angiography/intervention. METHODS:MEDLINE, Embase, Cochrane Central, and electronic databases were searched for studies that assessed the following: (1) patients with CS who underwent percutaneous coronary intervention (PCI) and (2) the association between choice of arterial access, 30-day all-cause mortality, and 30-day major adverse cardiac and cerebral events (MACCEs) using random-effects model. RESULTS:From 3,652 retrieved citations, 8 studies involving 8,131 patients with CS undergoing PCI (via TRA: 2,321 patients, via TFA: 5,810 patients) were included. Transradial access was associated with significantly reduced risk for all-cause mortality (unadjusted: risk ratio [RR] 0.60, 95% CI 0.52-0.71, P < .001, I(2) = 29%, 8 included studies; adjusted: RR 0.55, 95% CI 0.46-0.65, P < .001, I(2) = 0%, 6 included studies) and MACCE (unadjusted: RR 0.68, 95% CI 0.63-0.73, P < .001, I(2) = 0%, 6 included studies; adjusted: RR 0.63, 95% CI 0.52-0.75, P < .001, I(2) = 0%, 4 included studies) at 30 days when compared with TFA. CONCLUSIONS:Transradial access is associated with reduced mortality and MACCE at 30 days in patients with CS undergoing PCI. Considering the possible influence of selection bias on the effect estimate in our analysis, randomized controlled trials are needed to better assess this association.
PMID: 26299234
ISSN: 1097-6744
CID: 5224442

The Multidimensionality of Cardiovascular Procedures [Comment]

Rao, Sunil V
PMID: 26477636
ISSN: 1558-3597
CID: 5224462

A randomized, double-blind, placebo-controlled trial to evaluate the safety and effectiveness of intracoronary application of a novel bioabsorbable cardiac matrix for the prevention of ventricular remodeling after large ST-segment elevation myocardial infarction: Rationale and design of the PRESERVATION I trial

Rao, Sunil V; Zeymer, Uwe; Douglas, Pamela S; Al-Khalidi, Hussein; Liu, Jingyu; Gibson, C Michael; Harrison, Robert W; Joseph, Diane S; Heyrman, Reinilde; Krucoff, Mitchell W
Postinfarction left ventricular (LV) remodeling can result in chronic heart failure and functional impairment. Although pharmacological strategies for established heart failure can be beneficial, preventing remodeling remains a challenge. Injectable bioabsorbable alginate or "bioabsorbable cardiac matrix" (BCM), composed of an aqueous mixture of sodium alginate and calcium gluconate, is a sterile colorless liquid that is a polysaccharide polymer produced from brown seaweed. When exposed to excess ionized calcium present in infarcted myocardium, BCM assembles to form a flexible gel, structurally resembling extracellular matrix, which provides temporary structural support to the infarct zone through and beyond the time needed for mature fibrotic tissue to develop. The PRESERVATION I trial is an early phase randomized, double-blind, placebo-controlled trial comparing intracoronary application of 4 mL of BCM with saline control in patients who develop large infarctions after successful reperfusion of large ST-segment elevation myocardial infarction (MI). Subjects will be randomized 2:1 to either BCM or saline control and will have the study device deployed through an intracoronary microcatheter in the infarct-related artery 2 to 5 days after index ST-segment elevation MI treated with successful primary or rescue percutaneous coronary intervention. The primary effectiveness end point is the absolute change in LV diastolic volume index as measured by 3-dimensional echocardiography from baseline to 6 months after BCM deployment. Secondary effectiveness end points include clinical outcomes, patient-reported quality of life, additional echocardiographic measures, and functional status measures. In summary, the PRESERVATION I trial is a randomized double-blind trial evaluating the effectiveness and safety of the novel device BCM in preventing LV remodeling patients who have large MIs despite undergoing successful primary or rescue percutaneous coronary intervention.
PMID: 26542501
ISSN: 1097-6744
CID: 5224482

Proficiency With Vascular Access: Don't Rob Peter to Pay Paul [Editorial]

Rao, Sunil V; Nolan, Jim
PMID: 26604057
ISSN: 1876-7605
CID: 5224502

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