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622


The Impact of a Rigorous Quality Program on 3D Echocardiography Data Quality in an International Multisite Randomized Trial [Letter]

Crowley, Anna Lisa; Yow, Eric; Rabineau, Dawn; Norris, Casey; White, Jennifer; Daubert, Melissa A; Velazquez, Eric J; Barnhart, Huiman; Krucoff, Mitchell W; Rao, Sunil V; Douglas, Pamela S
PMID: 30121272
ISSN: 1876-7591
CID: 5221952

Association of Anemia With Outcomes Among ST-Segment-Elevation Myocardial Infarction Patients Receiving Primary Percutaneous Coronary Intervention

Moghaddam, Nima; Wong, Graham C; Cairns, John A; Goodman, Shaun G; Perry-Arnesen, Michele; Tocher, Wendy; Mackay, Martha; Singer, Joel; Lee, Terry; Rao, Sunil V; Fordyce, Christopher B
BACKGROUND:Anemia may confer a poor prognosis among patients with the acute coronary syndrome. However, few data exist on the association of anemia with in-hospital outcomes, including bleeding, among ST-segment-elevation myocardial infarction patients receiving primary percutaneous coronary intervention. METHODS AND RESULTS:) and multivariate logistic regression were used to evaluate the relationship of anemia on admission with clinical outcomes. Compared with nonanemic patients, anemic patients were more likely to have preexisting hypertension, diabetes mellitus, and prior myocardial infarction. Anemic patients had higher unadjusted rates of in-hospital death (8.1% versus 3.7%; P<0.001), bleeding (18.2% versus 9.4%; P<0.001), and were more likely to develop heart failure (odds ratio [OR], 1.62; 95% CI, 1.19-2.22), shock (OR, 2.35; 95% CI, 1.62-3.40), or cardiac arrest (OR, 1.94; 95% CI, 1.10-3.40) during their hospital stay. Baseline anemia was independently associated with major bleeding (OR, 1.78; 95% CI, 1.25-2.56) but not all-cause mortality (OR, 0.99; 95% CI, 0.57-1.73). There was no significant correlation between anemia and overall reperfusion times (OR, 0.95; 95% CI, 0.74-1.22). CONCLUSIONS:In a contemporary ST-segment-elevation myocardial infarction cohort receiving primary percutaneous coronary intervention, nearly 1 in 5 patients were anemic. Anemia was associated with increased comorbidities and higher-risk features on presentation and was independently associated with subsequent major in-hospital bleeding but not all-cause mortality. These results suggest that anemic ST-segment-elevation myocardial infarction patients may safely receive timely primary percutaneous coronary intervention but with particular consideration for bleeding avoidance strategies.
PMID: 30562086
ISSN: 1941-7632
CID: 5222092

Different Spasmolytic Regimens (Nitroglycerin vs Verapamil) and the Incidence of Radial Artery Occlusion After Transradial Catheterization

Dharma, Surya; Kedev, Sasko; Patel, Tejas; Rao, Sunil V; Gilchrist, Ian C
OBJECTIVE:This study evaluated whether use of different spasmolytic regimens (nitroglycerin or verapamil) administered soon after sheath insertion affects postprocedure radial artery occlusion (RAO) in patients who underwent transradial catheterization. METHODS AND RESULTS:We performed a post hoc analysis of a randomized trial evaluating the use of 500 μg intra-arterial nitroglycerin just before sheath removal in 1706 patients undergoing transradial catheterization. Patients who received 200 μg or 300 μg nitroglycerin after sheath placement (group A; n = 688) were compared with patients who received 5 mg verapamil after sheath placement (group B; n = 1018). The primary endpoint was RAO diagnosed by Doppler ultrasound examination at 1 calendar day after the procedure. Logistic regression was used to determine predictors of RAO. RAO occurred in 16.0% of group A and 5.4% of group B. After adjustment for potential confounders, neither the use of verapamil nor nitroglycerin was associated with RAO (odds ratio [OR], 1.24; 95% confidence interval [CI], 0.51-3.02; P=.62). Radial artery compression >4 hours was the strongest predictor of RAO (OR, 5.41; 95% CI, 2.31-12.65; P<.001). CONCLUSIONS:In this study, the use of verapamil or nitroglycerin as a spasmolytic regimen was not associated with RAO. Given the strong association between duration of radial compression and RAO, further studies are needed to determine the interaction between vasodilator agents and compression protocols on RAO.
PMID: 30504515
ISSN: 1557-2501
CID: 5222062

Preventing Acute Radial Artery Occlusion: A Battle on Multiple Fronts [Comment]

Rymer, Jennifer A; Rao, Sunil V
PMID: 30391385
ISSN: 1876-7605
CID: 5222032

Predictors and Outcomes of Staged Versus One-Time Multivessel Revascularization in Multivessel Coronary Artery Disease: Insights From the VA CART Program

Hu, Peter T; Jones, W Schuyler; Glorioso, Thomas J; Barón, Anna E; Grunwald, Gary K; Waldo, Stephen W; Maddox, Thomas M; Vidovich, Mladen; Banerjee, Subhash; Rao, Sunil V
OBJECTIVES:The aim of this study was to determine predictors and outcomes associated with staged percutaneous coronary intervention (PCI) versus one-time multivessel revascularization (OTMVR) in patients with multivessel coronary artery disease. BACKGROUND:Prior observational studies have not evaluated predictors and outcomes of staged PCI versus OTMVR in a heterogenous population of patients with multivessel coronary artery disease who undergo multivessel revascularization. METHODS:Data from the Veterans Affairs (VA) CART (Clinical Assessment, Reporting, and Tracking) Program were used to evaluate patients who underwent PCI of >2 vessels between October 1, 2007, and September 3, 2014. Associations between individual factors and the decision to perform staged PCI were assessed. Additionally, the impact of measured patient and procedural factors, site factors, and unmeasured site factors on the decision to perform staged PCI was compared. Cox proportional hazards models were used to determine the association between staged PCI and mortality. RESULTS:A total of 7,599 patients at 61 sites were included. The decision to perform staged PCI was driven by procedural characteristics and unmeasured site factors. Staged PCI was associated with lower risk-adjusted mortality compared with OTMVR (adjusted hazard ratio [HR]: 0.78; 95% confidence interval [CI]: 0.72 to 0.84; p < 0.01). This mortality benefit was observed among the ST-segment elevation myocardial infarction (HR: 0.31; 95% CI: 0.21 to 0.47; p < 0.01), non-ST-segment elevation myocardial infarction (HR: 0.74; 95% CI: 0.64 to 0.87; p < 0.01), unstable angina (HR: 0.75; 95% CI: 0.64 to 0.89; p < 0.01) and stable angina (HR: 0.88; 95% CI: 0.77 to 1.00; p = 0.05) groups. CONCLUSIONS:The decision to pursue staged PCI was driven by procedural characteristics and unmeasured site variation and was associated with lower mortality compared with OTMVR. After adjustment, there was an association between staged PCI and reduced mortality. Given the observational nature of these findings, a randomized trial comparing the 2 is needed to guide practice.
PMID: 30466824
ISSN: 1876-7605
CID: 5222052

Association of Same-Day Discharge After Elective Percutaneous Coronary Intervention in the United States With Costs and Outcomes

Amin, Amit P; Pinto, Duane; House, John A; Rao, Sunil V; Spertus, John A; Cohen, Mauricio G; Pancholy, Samir; Salisbury, Adam C; Mamas, Mamas A; Frogge, Nathan; Singh, Jasvindar; Lasala, John; Masoudi, Frederick A; Bradley, Steven M; Wasfy, Jason H; Maddox, Thomas M; Kulkarni, Hemant
Importance:Same-day discharge (SDD) after elective percutaneous coronary intervention (PCI) is associated with lower costs and preferred by patients. However, to our knowledge, contemporary patterns of SDD after elective PCI with respect to the incidence, hospital variation, trends, costs, and safety outcomes in the United States are unknown. Objective:To examine (1) the incidence and trends in SDD; (2) hospital variation in SDD; (3) the association between SDD and readmissions for bleeding, acute kidney injury (AKI), acute myocardial infarction (AMI), or mortality at 30, 90, and 365 days after PCI; and (4) hospital costs of SDD and its drivers. Design, Setting, and Participants:This observational cross-sectional cohort study included 672 470 patients enrolled in the nationally representative Premier Healthcare Database who underwent elective PCI from 493 hospitals between January 2006 and December 2015 with 1-year follow-up. Exposures:Same-day discharge, defined by identical dates of admission, PCI procedure, and discharge. Main Outcomes and Measures:Death, bleeding requiring a blood transfusion, AKI and AMI at 30, 90, or 365 days after PCI, and costs from hospitals' perspective, inflated to 2016. Results:Among 672 470 elective PCIs, 221 997 patients (33.0%) were women, 30 711 (4.6%) were Hispanic, 51 961 (7.7%) were African American, and 491 823 (73.1%) were white. The adjusted rate of SDD was 3.5% (95% CI, 3.0%-4.0%), which increased from 0.4% in 2006 to 6.3% in 2015. We observed substantial hospital variation for SDD from 0% to 83% (median incidence rate ratio, 3.82; 95% CI, 3.48-4.23), implying an average (median) 382% likelihood of SDD at one vs another hospital. Among SDD (vs non-SDD) patients, there was no higher risk of death, bleeding, AKI, or AMI at 30, 90, or 365 days. Same-day discharge was associated with a large cost savings of $5128 per procedure (95% CI, $5006-$5248), driven by reduced supply and room and boarding costs. A shift from existing SDD practices to match top-decile SDD hospitals could annually save $129 million in this sample and $577 million if adopted throughout the United States. However, residual confounding may be present, limiting the precision of the cost estimates. Conclusions and Relevance:Over 2006 to 2015, SDD after elective PCI was infrequent, with substantial hospital variation. Given the safety and large savings of more than $5000 per PCI associated with SDD, greater and more consistent use of SDD could markedly increase the overall value of PCI care.
PMID: 30267035
ISSN: 2380-6591
CID: 5222002

Efficacy and Safety of Drug-Eluting Stents Optimized for Biocompatibility vs Bare-Metal Stents With a Single Month of Dual Antiplatelet Therapy: A Meta-analysis

Shah, Rahman; Rao, Sunil V; Latham, Samuel B; Kandzari, David E
Importance:A significant number of patients receive bare-metal stents (BMSs) instead of drug-eluting stents (DESs) to shorten the duration of dual antiplatelet therapy (DAPT). Emerging evidence suggests that new-generation DESs, particularly those optimized for biocompatibility, may be more efficacious and safer than BMSs, even with a single month of DAPT after stent implantation. Objective:To evaluate the efficacy and safety of DESs compared with BMSs for coronary intervention with a single month of DAPT. Data Sources:Human studies found in PubMed, the Cochrane databases through April 2018, and reference lists of selected articles. Study Selection:Randomized clinical trials were included if they enrolled patients undergoing percutaneous coronary intervention and randomly assigned each patient to treatment with either DESs or BMSs. The additional inclusion criterion was use of only 1 month of DAPT poststent implantation. Data Extraction and Synthesis:Two reviewers independently extracted the data. Odds ratios (ORs) were calculated using random-effects models. Main Outcomes and Measures:The efficacy end points were major adverse cardiac events, myocardial infarction, target vessel revascularization, ischemia-driven target lesion revascularization, cardiac mortality, and all-cause mortality at 1 year. The safety outcomes were stent thrombosis and bleeding complications. Results:Data from 3 randomized clinical trials involving 3943 patients were included (2457 men [62.3%]; mean [SD] age ranging from 75.7 [9.3] years to 81.4 [4.3] years per trial subgroup). Coronary intervention with DESs reduced the rates for major adverse cardiac events (OR, 0.68 [95% CI, 0.57-0.82]; P < .001), target lesion revascularization (OR, 0.38 [95% CI, 0.22-0.67]; P = .001), target vessel revascularization (OR, 0.50 [95% CI, 0.38-0.65]; P < .001), and myocardial infarction (OR, 0.51 [95% CI, 0.31-0.83]; P = .01) compared with BMSs at 1 year. The incidence of stent thrombosis was also lower with DESs compared with BMSs (1.8% vs 2.8%), but this difference was not statistically significant in the random-effects model. Additionally, the 2 stent types did not differ in the risks of all-cause mortality, cardiac mortality, and bleeding. Conclusions and Relevance:In the limited number of randomized clinical trials comparing DESs with BMSs with shortened DAPT durations in patients who have high bleeding risk or are uncertain candidates for prolonged DAPT, coronary intervention with specific DESs optimized for biocompatibility is not only safe but also efficacious, even with only 1 month of DAPT.
PMID: 30383145
ISSN: 2380-6591
CID: 5222022

Heparin use for diagnostic cardiac catheterization with a radial artery approach: An international survey of practice patterns

Bossard, Matthias; Lavi, Shahar; Rao, Sunil V; Cohen, David J; Cantor, Warren J; Bainey, Kevin R; Valettas, Nicholas; Jolly, Sanjit S; Mehta, Shamir R
OBJECTIVES:We aimed to describe global practice patterns of unfractionated heparin (UFH) use for diagnostic transradial cardiac catheterization. BACKGROUND:The use of the radial artery approach for cardiac catheterization is increasing globally. Limited contemporary data exist to support the use or optimal dosing of UFH to prevent radial artery occlusion (RAO) and other thromboembolic complications. METHODS:We performed a web-based international survey of 450 interventional cardiologists from 34 countries. We collected information regarding the experience and use of UFH for diagnostic transradial cardiac catheterization. RESULTS:The survey was conducted between June and July 2016 and was completed by 227 (50.4%) interventional cardiologists. Overall, 83.3% performed >75% of their coronary angiograms via a radial approach, with the plurality (41.9%) having 10-20 years of clinical experience. Of all respondents, 7.5% did not use UFH for routine diagnostic transradial heart catheterization. Of the 92.5% who did use UFH, it was preferentially administered intra-arterially by 60% and intravenously by 40%. The majority (62.6%) of interventionalists used a fixed UFH dose with 5,000 IU being the most common dose (used in 48%). For those using a weight-based UFH (50 IU/kg) dosing regimen for diagnostic procedures (36.1%), the administered UFH dose ranged from 2,000 up to 10,000 IU. CONCLUSIONS:Despite the lack of firm evidence, the majority of interventional cardiologists who participated in the survey use UFH to prevent RAO for diagnostic transradial coronary angiography. However, there exist large practice disparities with regards to dose and route of administration. Given this knowledge gap, a dedicated randomized trial is warranted.
PMID: 29405556
ISSN: 1522-726x
CID: 5221792

Impact of sheath size and hemostasis time on radial artery patency after transradial coronary angiography and intervention in Japanese and non-Japanese patients: A substudy from RAP and BEAT (Radial Artery Patency and Bleeding, Efficacy, Adverse evenT) randomized multicenter trial

Aminian, Adel; Saito, Shigeru; Takahashi, Akihiko; Bernat, Ivo; Jobe, Robert Lee; Kajiya, Takashi; Gilchrist, Ian C; Louvard, Yves; Kiemeneij, Ferdinand; van Royen, Niels; van Leeuwen, Maarten; Yamazaki, Seiji; Matsukage, Takashi; Iglesias, Juan F; Rao, Sunil V
BACKGROUND:During transradial (TR) access, it remains unclear whether differences in baseline patients characteristics and hemostasis care impact the rate of radial artery occlusion (RAO). We sought to compare the rate of RAO after TR access with the 6 French(Fr) Glidesheath Slender (GSS6Fr, Terumo, Japan) or a standard 5 Fr sheath in Japanese and non-Japanese patients. METHODS AND RESULTS:The Radial Artery Patency and Bleeding, Efficacy, Adverse evenT (RAP and BEAT) trial randomized 1,836 patients undergoing TR coronary angiography and/or interventions to receive the GSS6Fr or the standard 5 Fr Glidesheath (GS5Fr, Terumo, Japan). Out of this study population, 1,087 were Japanese patients and 751 non-Japanese patients. The overall incidence of RAO was significantly higher in Japanese patients (3.6% vs. 1.2%, P = 0.002). Use of GSS6Fr was associated with higher rates of RAO than GS5Fr in Japanese patients (5% vs. 2.2%, P = 0.02) and with similar RAO rates in non-Japanese patients (1.3 vs. 1.1%, P = 1). The mean hemostasis time was significantly longer in Japanese patients (378 ± 253 vs. 159 ± 136 min, P < 0.001) and more Japanese patients had a hemostasis time of more than 6 hr (16.2% vs. 4.9%, P < 0.0001). Longer hemostasis time was an independent predictor of RAO (OR per additional hour 1.070, 95% CI 1.008-1.136, P = 0.03). CONCLUSIONS:Use of GSS6Fr was associated with a higher rate of RAO than a standard 5 Fr sheath in Japanese patients but not in non-Japanese patients. Whether improvement in post-procedural care and reduced hemostasis time could impact the incidence of RAO in Japanese patients should be further assessed.
PMID: 29451949
ISSN: 1522-726x
CID: 5221822

Percutaneous or surgical access for transfemoral transcatheter aortic valve implantation

Vora, Amit N; Rao, Sunil V
Transcatheter aortic valve implantation is an important therapeutic option for patients with symptomatic, severe aortic stenosis at increased risk for open surgical aortic valve replacement. Although a number of alternative vascular access sites have been developed, transfemoral access is overwhelmingly the dominant access strategy for this procedure. Access was achieved in the initial clinical experience primarily via surgical cutdown, but more recently, there has been increasing use of a fully percutaneous approach. This is likely driven by improvements in technology, more experience with large bore vascular closure devices (VCDs), and pressures to reduce hospital length of stay. This review will describe temporal trends of percutaneous versus surgical transfemoral access, identify the advantages and disadvantages of each approach, and describe the best practices for achieving safe transfemoral percutaneous access.
PMCID:6242926
PMID: 30505540
ISSN: 2072-1439
CID: 5222072