270 results on '"Rao, Sunil V."'
Search Results
2. Evaluating the Use of Unfractionated Heparin with Intra-Aortic Balloon Counterpulsation
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Nuti, Olivia, Merchan, Cristian, Papadopoulos, John, Horowitz, James, Rao, Sunil V., and Ahuja, Tania
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- 2024
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3. Characterization of peripheral artery disease and associations with traditional risk factors, mobility, and biomarkers in the project baseline health study.
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Kercheval, Jacquelyn B., Narcisse, Dennis I., Nguyen, Maggie, Rao, Sunil V., Gutierrez, J. Antonio, Leeper, Nicholas J., Maron, David J., Rodriguez, Fatima, Hernandez, Adrian F., Mahaffey, Kenneth W., Shah, Svati H., and Swaminathan, Rajesh V.
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There is a dearth of research on immunophenotyping in peripheral artery disease (PAD). This study aimed to describe the baseline characteristics, immunophenotypic profile, and quality of life (QoL) of participants with PAD in the Project Baseline Health Study (PBHS). The PBHS study is a prospective, multicenter, longitudinal cohort study that collected clinical, molecular, and biometric data from participants recruited between 2017 and 2018. In this analysis, baseline demographic, clinical, mobility, QoL, and flow cytometry data were stratified by the presence of PAD (ankle brachial index [ABI] ≤0.90). Of 2,209 participants, 58 (2.6%) had lower-extremity PAD, and only 2 (3.4%) had pre-existing PAD diagnosed prior to enrollment. Comorbid smoking (29.3% vs 14%, P <.001), hypertension (54% vs 30%, P <.001), diabetes (25% vs 14%, P =.031), and at least moderate coronary calcifications (Agatston score >100: 32% vs 17%, P =.01) were significantly higher in participants with PAD than in those with normal ABIs, as were high-sensitivity C-reactive protein levels (5.86 vs 2.83, P <.001). After adjusting for demographic and risk factors, participants with PAD had significantly fewer circulating CD56-high natural killer cells, IgM+ memory B cells, and CD10/CD27 double-positive B cells (P <.05 for all). This study reinforces existing evidence that a large proportion of PAD without claudication may be underdiagnosed, particularly in female and Black or African American participants. We describe a novel immunophenotypic profile of participants with PAD that could represent a potential future screening or diagnostic tool to facilitate earlier diagnosis of PAD. NCT03154346, https://clinicaltrials.gov/ct2/show/NCT03154346 [ABSTRACT FROM AUTHOR]
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- 2024
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4. Radial artery diameter does not correlate with body mass index: A duplex ultrasound analysis of 1706 patients undergoing trans-radial catheterization at three experienced radial centers
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Dharma, Surya, Kedev, Sasko, Patel, Tejas, Rao, Sunil V, Bertrand, Olivier F, and Gilchrist, Ian C
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- 2017
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5. Transradial approach for coronary angiography and intervention in the elderly: A meta-analysis of 777,841 patients
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Alnasser, Sami M., Bagai, Akshay, Jolly, Sanjit S., Cantor, Warren J., Dehghani, Payam, Rao, Sunil V., and Cheema, Asim N.
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- 2017
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6. Management of Adults With Anomalous Aortic Origin of the Coronary Arteries: State-of-the-Art Review.
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Gaudino, Mario, Di Franco, Antonino, Arbustini, Eloisa, Bacha, Emile, Bates, Eric R., Cameron, Duke E., Cao, Davide, David, Tirone E., De Paulis, Ruggero, El-Hamamsy, Ismail, Farooqi, Kanwal M., Girardi, Leonard N., Gräni, Christoph, Kochav, Jonathan D., Molossi, Silvana, Puskas, John D., Rao, Sunil V., Sandner, Sigrid, Tatoulis, James, and Truong, Quynh A.
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As a result of increasing adoption of imaging screening, the number of adult patients with a diagnosis of anomalous aortic origin of the coronary arteries (AAOCA) has grown in recent years. Existing guidelines provide a framework for management and treatment, but patients with AAOCA present with a wide range of anomalies and symptoms that make general recommendations of limited applicability. In particular, a large spectrum of interventions can be used for treatment, and there is no consensus on the optimal approach to be used. In this paper, a multidisciplinary group of clinical and interventional cardiologists and cardiac surgeons performed a systematic review and critical evaluation of the available evidence on the interventional treatment of AAOCA in adult patients. Using a structured Delphi process, the group agreed on expert recommendations that are intended to complement existing clinical practice guidelines. [Display omitted] [ABSTRACT FROM AUTHOR]
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- 2023
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7. Outcomes and Institutional Variation in Arterial Access Among Patients With AMI and Cardiogenic Shock Undergoing PCI.
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Mahtta, Dhruv, Manandhar, Pratik, Wegermann, Zachary K., Wojdyla, Daniel, Megaly, Michael, Kochar, Ajar, Virani, Salim S., Rao, Sunil V., and Elgendy, Islam Y.
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Contemporary data comparing the outcomes of transradial access (TRA) vs transfemoral access (TFA) among patients presenting with acute myocardial infarction and cardiogenic shock (AMI-CS) undergoing percutaneous coronary intervention (PCI) are limited. This study examines in-hospital outcomes and institutional variation among patients with AMI-CS undergoing TRA-PCI vs TFA-PCI. Patients admitted with AMI-CS from the NCDR CathPCI registry between April 2018 and June 2021 were included. Multivariable logistic regression and inverse probability weighting models were used to assess the association between access site and in-hospital outcomes. A falsification analysis using non-access site–related bleeding was performed. Among 35,944 patients with AMI-CS undergoing PCI, 25.6% were performed with TRA. The proportion of TRA-PCI increased over the study period (22.0% in the second quarter of 2018 vs 29.1% in the second quarter of 2021; P -trend <0.001). Significant institutional-level variability in the use of TRA-PCI was also observed: 20.9% of all sites using TRA in <2% of PCIs (low utilization) vs 1.9% of all sites using TRA in >80% of PCIs (high utilization). Patients undergoing TRA-PCI had a significantly lower adjusted incidence of major bleeding (odds ratio [OR]: 0.71; 95% confidence interval [CI]: 0.67-0.76), mortality (OR: 0.73; 95% CI: 0.69-0.78), vascular complications (OR: 0.67; 95% CI: 0.54-0.84), and new dialysis (OR: 0.86; 95% CI: 0.77-0.97). There was no difference in non-access site related bleeding (OR: 0.93; 95% CI: 0.84-1.03). Sensitivity analyses revealed similar benefit with TRA-PCI among patients without arterial cross-over. There were no significant interactions observed between TRA-PCI with mechanical circulatory support and in-hospital outcomes. In this large nationwide contemporary analysis of patients with AMI-CS, about quarter of PCIs were performed via TRA with wide variability across US institutions. TRA-PCI was associated with significantly lower incidence of in-hospital major bleeding, mortality, vascular complications, and new dialysis. This benefit was observed irrespective of mechanical circulatory support use. [Display omitted] [ABSTRACT FROM AUTHOR]
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- 2023
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8. International Psychological Well-Being Survey of Interventional Cardiologists.
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Simsek, Bahadir, Rempakos, Athanasios, Kostantinis, Spyridon, Karacsonyi, Judit, Rangan, Bavana V., Mastrodemos, Olga C., Kirtane, Ajay J., Bortnick, Anna E., Jneid, Hani, Azzalini, Lorenzo, Milkas, Anastasios, Alaswad, Khaldoon, Linzer, Mark, Egred, Mohaned, Allana, Salman S., Rao, Sunil V., Sandoval, Yader, and Brilakis, Emmanouil S.
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- 2023
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9. Rationale and Design for the Myocardial Ischemia and Transfusion (MINT) Randomized Clinical Trial.
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Carson, Jeffrey L., Brooks, Maria Mori, Chaitman, Bernard R., Alexander, John H., Goodman, Shaun G., Bertolet, Marnie, Abbott, J. Dawn, Cooper, Howard A., Rao, Sunil V., Triulzi, Darrell J., Fergusson, Dean A., Kostis, William J., Noveck, Helaine, Simon, Tabassome, Steg, Philippe Gabriel, DeFilippis, Andrew P., Goldsweig, Andrew M., Lopes, Renato D., White, Harvey, and Alsweiler, Caroline
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Background: Accumulating evidence from clinical trials suggests that a lower (restrictive) hemoglobin threshold (<8% g/dL) for red blood cell (RBC) transfusion, compared with a higher (liberal) threshold (≥10 g/dL) is safe. However, in anemic patients with acute myocardial infarction (MI), maintaining a higher hemoglobin level may increase oxygen delivery to vulnerable myocardium resulting in improved clinical outcomes. Conversely, RBC transfusion may result in increased blood viscosity, vascular inflammation, and reduction in available nitric oxide resulting in worse clinical outcomes. We hypothesize that a liberal transfusion strategy would improve clinical outcomes as compared to a more restrictive strategy.Methods: We will enroll 3500 patients with acute MI (type 1, 2, 4b or 4c) as defined by the Third Universal Definition of MI and a hemoglobin <10 g/dL at 144 centers in the United States, Canada, France, Brazil, New Zealand, and Australia. We randomly assign trial participants to a liberal or restrictive transfusion strategy. Participants assigned to the liberal strategy receive transfusion of RBCs sufficient to raise their hemoglobin to at least 10 g/dL. Participants assigned to the restrictive strategy are permitted to receive transfusion of RBCs if the hemoglobin falls below 8 g/dL or for persistent angina despite medical therapy. We will contact each participant at 30 days to assess clinical outcomes and at 180 days to ascertain vital status. The primary endpoint is a composite of all-cause death or recurrent MI through 30 days following randomization. Secondary endpoints include all-cause mortality at 30 days, recurrent adjudicated MI, and the composite outcome of all-cause mortality, nonfatal recurrent MI, ischemia driven unscheduled coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting), or readmission to the hospital for ischemic cardiac diagnosis within 30 days. The trial will assess multiple tertiary endpoints.Conclusions: The MINT trial will inform RBC transfusion practice in patients with acute MI. [ABSTRACT FROM AUTHOR]- Published
- 2023
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10. Real-World Examination of Revascularization Strategies for Left Main Coronary Disease in Ontario, Canada.
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Tam, Derrick Y., Fang, Jiming, Rocha, Rodolfo V., Rao, Sunil V., Dzavik, Vladimir, Lawton, Jennifer, Austin, Peter C., Gaudino, Mario, Fremes, Stephen E., and Lee, Douglas S.
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Randomized trials have compared percutaneous coronary intervention and coronary artery bypass grafting (CABG) in patients with left main coronary artery disease undergoing nonemergent revascularization. However, there is a paucity of real-world contemporary observational studies comparing percutaneous coronary intervention (PCI) and CABG. The purpose of this study was to compare the long-term clinical outcomes of CABG versus PCI in patients with left main coronary disease. Clinical and administrative databases for Ontario, Canada, were linked to obtain records of all patients with angiographic evidence of left main coronary artery disease (≥50% stenosis) treated with either isolated CABG or PCI from 2008 to 2020. Emergent, cardiogenic shock, and ST-segment elevation myocardial infarction patients were excluded. Baseline characteristics of patients were compared and 1:1 propensity score matching was performed. Late mortality and major adverse cardiac and cerebrovascular events were compared between the matched groups using a Cox proportional hazard model. After exclusions, 1,299 and 21,287 patients underwent PCI and CABG, respectively. Prior to matching, PCI patients were older (age 75.2 vs 68.0 years) and more likely to be women (34.6% vs 20.1%), although they had less CAD burden. Propensity score matching on 25 baseline covariates yielded 1,128 well-matched pairs. There was no difference in early mortality between PCI and CABG (5.5% vs 3.9%; P = 0.075). Over 7-year follow-up, all-cause mortality (53.6% vs 35.2%; HR: 1.63; 95% CI: 1.42-1.87; P < 0.001) and major adverse cardiac and cerebrovascular events (66.8% vs 48.6%; HR: 1.77; 95% CI: 1.57-2.00) were significantly higher with PCI than CABG. CABG was the most common revascularization strategy in this real-world registry. Patients undergoing PCI were much older and of higher risk at baseline. After matching, there was no difference in early mortality but improved late survival and freedom from major adverse cardiac and cerebrovascular events with CABG. [Display omitted] [ABSTRACT FROM AUTHOR]
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- 2023
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11. Comparing the Classification of Percutaneous Coronary Interventions Using the 2012 and 2017 Appropriate Use Criteria: Insights From 245,196 Patients in the NCDR CathPCI Registry.
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Nelson, Adam J, Inohara, Taku, Rao, Sunil V., Kaltenbach, Lisa A., Wojdyla, Daniel, and Wang, Tracy Y.
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Background: Appropriate use criteria (AUC) have been developed to promote the rational use of percutaneous coronary intervention (PCI) among clinicians and to provide benchmarking feedback to hospitals. The original AUC were published in 2012 and subsequently updated in 2017 to reflect emerging, contemporary evidence however the degree to which the updated guidance re-classifies PCI appropriateness is unknown.Methods: Elective PCI cases from March 1, 2018 until June 30, 2021 were identified from within the NCDR CathPCI database. PCI cases were classified as 'appropriate,' 'uncertain' or 'inappropriate' under 2012 AUC and 'appropriate,' 'may be appropriate' or 'rarely appropriate' under 2017 AUC; those with missing data elements were termed 'not mappable.' Groups that 'remained appropriate' (appropriate in both 2012 and 2017), 'became non-appropriate' ('appropriate' in 2012 but became either 'may be appropriate' or 'rarely appropriate in 2017) and 'became appropriate' ('appropriate' in 2017 but were 'uncertain' or 'inappropriate' in 2012) were descriptively compared. Concordance was assessed by calculation of Cohen's Kappa.Results: A total of 245,196 patients underwent elective PCI across 1669 centers. By 2012 AUC, 44% were classified 'appropriate,' 28% were 'uncertain' and 16% were 'inappropriate' compared with 2017 AUC which considered 34% 'appropriate', 56% may be 'appropriate' and 4% 'rarely appropriate'. Overall fair agreement was observed with a Kappa statistic of 0.40 (95%CI 0.396-0.403). Compared with PCI that 'remained appropriate' under the 2017 AUC, PCI that 'became non-appropriate' in 2017 were more likely to be asymptomatic, less likely to be on anti-anginals and less likely to have complex lesions. Compared with PCI that 'became non-appropriate', PCI that 'became appropriate' had a higher proportion of atypical and non-anginal symptoms and were less likely to have had positive functional tests. Procedural related outcomes were similar across all groups. A total of 29 429 PCI (12.0%) were not mappable by 2012 AUC while 16 077 (6.6%) were not mappable by 2017 AUC.Conclusions: In this contemporary analysis of patients undergoing PCI in the United States, only fair agreement between the 2012 and updated 2017 AUC was observed. While some of this reflects the intention of the updated guidance, the large proportion that were considered 'maybe appropriate' or who 'became non-appropriate' reflect the difficulties of documenting and implementing contemporary AUC guidance. [ABSTRACT FROM AUTHOR]- Published
- 2023
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12. Distal vs Conventional Radial Access for Coronary Angiography and/or Intervention: A Meta-Analysis of Randomized Trials.
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Ferrante, Giuseppe, Condello, Francesco, Rao, Sunil V., Maurina, Matteo, Jolly, Sanjit, Stefanini, Giulio G., Reimers, Bernhard, Condorelli, Gianluigi, Lefèvre, Thierry, Pancholy, Samir B., Bertrand, Olivier, and Valgimigli, Marco
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Emerging evidence from randomized clinical trials (RCTs) comparing distal radial access (DRA) with conventional radial access (RA) is available. The aim of this study was to provide a quantitative appraisal of the effects of DRA) vs conventional RA for coronary angiography with or without intervention. The PubMed, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov databases were searched for RCT comparing DRA vs conventional RA for coronary angiography and/or intervention. Data were pooled by meta-analysis using a random-effects model. The primary endpoint was radial artery occlusion (RAO) at the longest available follow-up. Fourteen studies enrolling 6,208 participants were included. Compared with conventional RA, DRA was associated with a significant lower risk of RAO, either detected at latest follow-up (risk ratio [RR]: 0.36; 95% CI: 0.23-0.56; P < 0.001; number needed to treat [NNT] = 30) or in-hospital (RR: 0.32; 95% CI: 0.19-0.53; P < 0.001; NNT = 28), as well as EASY (Early Discharge After Transradial Stenting of Coronary Arteries) ≥II hematoma (RR: 0.51; 95% CI: 0.27-0.96; P = 0.04; NNT = 107). By contrast, DRA was associated with a higher risk of access site crossover (RR: 3.08; 95% CI: 1.88-5.06; P < 0.001; NNT = 12), a longer time for radial puncture (standardized mean difference [SMD]: 3.56; 95% CI: 0.96-6.16; P < 0.001), a longer time for sheath insertion (SMD: 0.37; 95% CI: 0.16-0.58; P < 0.001), and a higher number of puncture attempts (SMD: 0.59, 95% CI: 0.48-0.69; P < 0.001). Compared with conventional RA, DRA is associated with lower risks of RAO and EASY ≥II hematoma but requires longer time for radial artery cannulation and sheath insertion, more puncture attempts, and a higher access site crossover. [Display omitted] [ABSTRACT FROM AUTHOR]
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- 2022
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13. Position Statement on Vascular Access Safety for Percutaneous Devices in AMI Complicated by Cardiogenic Shock.
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Damluji, Abdulla A., Tehrani, Behnam, Sinha, Shashank S., Samsky, Marc D., Henry, Timothy D., Thiele, Holger, West, Nick E.J., Senatore, Fortunato F., Truesdell, Alexander G., Dangas, George D., Smilowitz, Nathaniel R., Amin, Amit P., deVore, Adam D., Moazami, Nader, Cigarroa, Joaquin E., Rao, Sunil V., Krucoff, Mitchell W., Morrow, David A., and Gilchrist, Ian C.
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In the United States, the frequency of using percutaneous mechanical circulatory support devices for acute myocardial infarction complicated by cardiogenic shock is increasing. These devices require large-bore vascular access to provide left, right, or biventricular cardiac support, frequently under urgent/emergent circumstances. Significant technical and logistical variability exists in device insertion, care, and removal in the cardiac catheterization laboratory and in the cardiac intensive care unit. This variability in practice may contribute to adverse outcomes observed in centers that receive patients with cardiogenic shock, who are at higher risk for circulatory insufficiency, venous stasis, bleeding, and arterial hypoperfusion. In this position statement, we aim to: 1) describe the public health impact of bleeding and vascular complications in cardiogenic shock; 2) highlight knowledge gaps for vascular safety and provide a roadmap for a regulatory perspective necessary for advancing the field; 3) propose a minimum core set of process elements, or "vascular safety bundle"; and 4) develop a possible study design for a pragmatic trial platform to evaluate which structured approach to vascular access drives most benefit and prevents vascular and bleeding complications in practice. [Display omitted] • Major bleeding and vascular complications are common in patients with AMI complicated by cardiogenic shock and contribute to morbidity and mortality. • There is substantial variability in practice relating to vascular access, cardiac critical care delivery, device removal, and vascular closure among institutions and individual operators. • Standardization of vascular access and closure techniques and approach to cardiac critical care management using "safety bundles" have the potential to favorably impact health outcomes during cardiogenic shock care. [ABSTRACT FROM AUTHOR]
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- 2022
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14. Shortening the duration of dual antiplatelet therapy after percutaneous coronary intervention for acute coronary syndrome: A systematic review and meta-analysis.
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Park, Dae Yong, Wang, Peter, An, Seokyung, Grimshaw, Alyssa A., Frampton, Jennifer, Ohman, E Magnus, Rao, Sunil V., and Nanna, Michael G.
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Introduction: The decision to shorten the duration of DAPT following PCI in patients with ACS remains controversial because of the concern for increased ischemic events.Methods: We performed a comprehensive literature search in seven databases to explore the efficacy of 1 to 3 months of DAPT in patients who underwent PCI for ACS. Randomized controlled trials that compared 1 to 3 months with 6 to 12 months of DAPT after PCI for ACS were identified. Integrated hazard ratio (HR) and 95% confidence interval (CI) were calculated by random effects model for each prespecified outcome of interest. Meta-regression analyses were performed to examine the association of outcomes with select patient characteristics.Results: A total of 9 randomized controlled trials consisting of 25,907 patients were included. There was no difference in the hazard of NACE (HR 0.92, 95% CI 0.79-1.07) and MACE (HR 0.96, 95% CI 0.78-1.17) between 1 and 3 months of DAPT and 6 to 12 months of DAPT. However, implementing 1 to 3 months of DAPT was associated with lower hazard of both any bleeding (HR 0.55, 95% CI 0.46-0.66) and major bleeding (HR 0.47, 95% CI 0.36-0.62). Meta-regression revealed a nonsignificant but increasing trend of both NACE and MACE with greater proportion of left main and left anterior descending coronary artery lesions and greater proportion of STEMI included in the trials.Conclusion: Our findings suggest that 1 to 3 months of DAPT has similar efficacy for preventing ischemic events with reduced bleeding risk compared with 6 to 12 months of DAPT. [ABSTRACT FROM AUTHOR]- Published
- 2022
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15. Dual antiplatelet therapy duration after percutaneous coronary intervention using drug eluting stents in high bleeding risk patients: A systematic review and meta-analysis.
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Garg, Aakash, Rout, Amit, Farhan, Serdar, Waxman, Sergio, Giustino, Gennaro, Tayal, Raj, Abbott, Jinette Dawn, Huber, Kurt, Angiolillo, Dominick J., and Rao, Sunil V.
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Background: Optimal dual antiplatelet therapy (DAPT) duration in patients at high bleeding risk (HBR) is not fully defined. We aimed to compare the safety and effectiveness of short-term DAPT (S-DAPT) with longer duration DAPT (L-DAPT) after percutaneous coronary intervention (PCI) with drug eluting stents (DES) in patients at HBR.Methods: We searched for studies comparing S-DAPT (≤3 months) followed by aspirin or P2Y 12 inhibitor monotherapy against L-DAPT (6-12 months) after PCI in HBR patients. Primary end points of interest were major bleeding and myocardial infarction (MI). Random-effects meta-analyses were performed to calculate odds ratios with 95% CIs.Results: Six randomized trials and 3 propensity-matched studies (n = 16,848) were included in the primary analysis. Compared with L-DAPT (n = 8,422), major bleeding was lower with S-DAPT (n = 8,426) [OR 0.68; 95% CI 0.51-0.89] whereas MI did not differ significantly between the 2 groups [1.16; 0.94-1.44]. There were no significant differences in risks of death, stroke or stent thrombosis (ST) between S-DAPT and L-DAPT groups. These findings were consistent when propensity-matched studies were analysed separately. Finally, there was a numerically higher, albeit statistically non-significant, ST in the S-DAPT arm of patients without an indication for OAC [1.98; 0.86-4.58].Conclusions: Among HBR patients undergoing current generation DES implantation, S-DAPT reduces bleeding without an increased risk of death or MI compared with L-DAPT. More research is needed to (1) evaluate risks of late ST after 1 to 3 months DAPT among patients with high ischemic and bleeding risks, (2) defining the SAPT of choice after 1 to 3 months DAPT. [ABSTRACT FROM AUTHOR]- Published
- 2022
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16. Implications of the 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Chest Pain Guideline for Cardiovascular Imaging: A Multisociety Viewpoint.
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Blankstein, Ron, Shaw, Leslee J., Gulati, Martha, Atalay, Michael K., Bax, Jeroen, Calnon, Dennis A., Dyke, Christopher K., Ferencik, Maros, Heitner, Jonathan F., Henry, Timothy D., Hung, Judy, Knuuti, Juhani, Lindner, Jonathan R., Phillips, Lawrence M., Raman, Subha V., Rao, Sunil V., Rybicki, Frank J., Saraste, Antti, Stainback, Raymond F., and Thompson, Randall C.
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- 2022
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17. Patterns and outcomes of drug-eluting coronary stent use in clinical practice
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Rao, Sunil V., Shaw, Richard E., Brindis, Ralph G., Klein, Lloyd W., Weintraub, William S., Krone, Ronald J., and Peterson, Eric D.
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Cardiology ,Medical colleges ,Stent (Surgery) ,Health - Abstract
To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.ahj.2006.03.005 Byline: Sunil V. Rao (a), Richard E. Shaw (b), Ralph G. Brindis (c), Lloyd W. Klein (d), William S. Weintraub (e), Ronald J. Krone (f), Eric D. Peterson (a) Abstract: To determine patterns and outcomes of drug-eluting stents (DES) use in clinical practice. Author Affiliation: (a) The Duke Clinical Research Institute, Durham, NC (b) Sutter Pacific Heart Centers, San Francisco, CA (c) Division of Cardiology, Oakland Kaiser Hospital, Oakland, CA (d) Division of Cardiology, Rush University Medical Center, Chicago, IL (e) Division of Cardiology, Christiana Healthcare Services, Newark, DE (f) Washington University School of Medicine, St. Louis, MO Article History: Received 18 November 2005; Accepted 8 March 2006 Article Note: (footnote) This analysis was supported by The American College of Cardiology National Cardiovascular Data Registry.
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- 2006
18. Highlights from the american college of cardiology annual scientific sessions 2003: March 28 to April 2, 2003
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Petersen, John L., Dery, Jean-Pierre, Fischi, Michael C., Hernandez, Adrian F., Hranitzky, Patrick M., Rao, Sunil V., Rebeiz, Abdallah G., and Singh, Kanwar P.
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Coronary stenosis -- Research ,Coronary stenosis -- Care and treatment ,Cardiology -- Research ,Health ,American College of Cardiology -- Conferences, meetings and seminars - Published
- 2003
19. Electronic alerts to initiate anticoagulation dialogue in patients with atrial fibrillation.
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Gutierrez, J. Antonio, Christian, Ruff T., Aday, Aaron W., Gu, Lin, Schulteis, Ryan D., Shihai, Lu, Petrini, Michaela, Sun, Albert Y., Swaminathan, Rajesh V., Katzenberger, Daniel R., Banerjee, Subhash, and Rao, Sunil V.
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Importance: The benefit of an electronic support system for the prescription and adherence to oral anticoagulation therapy among patients with atrial fibrillation (AF) and atrial flutter at heightened risk for of stroke and systemic thromboembolism is unclear.Objective: To evaluate the effect of a combined alert intervention and shared decision-making tool to improve prescription rates of oral anticoagulation therapy and adherence.Design, Setting, and Participants: A prospective single arm study of 939 consecutive patients treated at a large tertiary healthcare system.Exposures: An electronic support system comprising 1) an electronic alert to identify patients with AF or atrial flutter, a CHA2DS2-VASc score ≥ 2, and not on oral anticoagulation and 2) electronic shared decision-making tool to promote discussions between providers and patients regarding therapy.Main Outcomes and Measures: The primary endpoint was prescription rate of anticoagulation therapy. The secondary endpoint was adherence to anticoagulation therapy defined as medication possession ratio ≥ 80% during the 12 months of follow-up.Results: Between June 13, 2018 and August 31, 2018, the automated intervention identified and triggered a unique alert for 939 consecutive patients with AF or atrial flutter, a CHA2DS2-VASc score ≥2 who were not on oral anticoagulation. The median CHA2DS2-VASc score among all patients identified by the alert was 2 and the median untreated duration prior to the alert was 495 days (interquartile range 123 - 1,831 days). Of the patients identified by the alert, 345 (36.7%) initiated anticoagulation therapy and 594 (63.3%) did not: 68.7% were treated with a non-Vitamin K antagonist oral anticoagulant (NOAC), 22.0% with warfarin, and 9.3 % combination of NOAC and warfarin. Compared with historical anticoagulation rates, the electronic alert was associated with a 23.6% increase in anticoagulation prescriptions. The overall 1-year rate of adherence to anticoagulant therapy was 75.4% (260/345).Conclusion and Relevance: An electronic automated alert can successfully identify patients with AF and atrial flutter at high risk for stroke, increase oral anticoagulation prescription, and support high rates of adherence. [ABSTRACT FROM AUTHOR]- Published
- 2022
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20. Highlights from the American Heart Association Annual Scientific Sessions 2001: November 11 to 14, 2001
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Kandzari, David E., Kay, Joseph, O'Shea, J. Conor, Trichon, Benjamin H., Donahue, Mark, Liao, Lawrence, and Rao, Sunil V.
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Heart diseases -- Research ,Health ,American Heart Association -- Conferences, meetings and seminars - Published
- 2002
21. Treatment of diabetes mellitus: implications of the use of oral agents
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Rao, Sunil V., Bethel, M. Angelyn, and Feinglos, Mark N.
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Type 2 diabetes -- Drug therapy ,Cardiovascular diseases -- Prevention ,Health - Published
- 1999
22. The bleeding risk treatment paradox at the physician and hospital level: Implications for reducing bleeding in patients undergoing percutaneous coronary intervention.
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Amin, Amit P., Frogge, Nathan, Kulkarni, Hemant, Ridolfi, Gene, Ewald, Gregory, Miller, Rachel, Hall, Bruce, Rogers, Susan, Gluckman, Ty, Curtis, Jeptha, Masoudi, Frederick A., and Rao, Sunil V.
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Background: Bleeding is a common and costly complication of percutaneous coronary intervention (PCI). Bleeding avoidance strategies (BAS) are used paradoxically less in patients at high-risk of bleeding: "bleeding risk-treatment paradox" (RTP). We determined whether hospitals and physicians, who do not align BAS to PCI patients' bleeding risk (ie, exhibit a RTP) have higher bleeding rates.Methods: We examined 28,005 PCIs from the National Cardiovascular Data Registry CathPCI Registry for 7 hospitals comprising BJC HealthCare. BAS included transradial intervention, bivalirudin, and vascular closure devices. Patients' predicted bleeding risk was based on National Cardiovascular Data Registry CathPCI bleeding model and categorized as low (<2.0%), moderate (2.0%-6.4%), or high (≥6.5%) risk tertiles. BAS use was considered risk-concordant if: at least 1 BAS was used for moderate risk; 2 BAS were used for high risk and bivalirudin or vascular closure devices were not used for low risk. Absence of risk-concordant BAS use was defined as RTP. We analyzed inter-hospital and inter-physician variation in RTP, and the association of RTP with post-PCI bleeding.Results: Amongst 28,005 patients undergoing PCI by 103 physicians at 7 hospitals, RTP was observed in 12,035 (43%) patients. RTP was independently associated with a higher likelihood of bleeding even after adjusting for predicted bleeding risk, mortality risk and potential sources of variation (OR 1.66, 95% CI 1.44-1.92, P < .001). A higher prevalence of RTP strongly and independently correlated with worse bleeding rates, both at the physician-level (Wilk's Lambda 0.9502, F-value 17.21, P < .0001) and the hospital-level (Wilk's Lambda 0.9899, F-value 35.68, P < .0001). All the results were similar in a subset of PCIs conducted since 2015 - a period more reflective of the contemporary practice.Conclusions: Bleeding RTP is a strong, independent predictor of bleeding. It exists at the level of physicians and hospitals: those with a higher rate of RTP had worse bleeding rates. These findings not only underscore the importance of recognizing bleeding risk upfront and using BAS in a risk-aligned manner, but also inform and motivate national efforts to reduce PCI-related bleeding. [ABSTRACT FROM AUTHOR]- Published
- 2022
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23. Trends in Use and Outcomes of Same-Day Discharge Following Elective Percutaneous Coronary Intervention.
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Bradley, Steven M., Kaltenbach, Lisa A., Xiang, Katelyn, Amin, Amit P., Hess, Paul L., Maddox, Thomas M., Poulose, Anil, Brilakis, Emmanouil S., Sorajja, Paul, Ho, P. Michael, and Rao, Sunil V.
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The aims of this study were to describe trends and hospital variation in same-day discharge following elective percutaneous coronary intervention (PCI) and to evaluate the association between trends in same-day discharge and patient outcomes. Insights on contemporary use of same-day discharge following elective PCI are limited. In a sequential cross-sectional analysis of 819,091 patients undergoing elective PCI at 1,716 hospitals in the National Cardiovascular Data Registry CathPCI Registry from July 1, 2009, to December 31, 2017, overall and hospital-level trends in same-day discharge were assessed. Among the 212,369 patients who linked to Centers for Medicare and Medicaid Services data, the association between same-day discharge and 30-day mortality and rehospitalization was assessed. A total of 114,461 patients (14.0%) were discharged the same day as PCI. The proportion of patients with same-day discharge increased from 4.5% in the third quarter of 2009 to 28.6% in the fourth quarter of 2017. From 2009 to 2017, the rate of same-day discharge increased from 4.3% to 19.5% for femoral-access PCI and from 9.9% to 39.7% for radial-access PCI. Hospital-level variation in the use of same-day discharge persisted throughout (median odds ratio adjusted for year and radial access: 4.15). Risk-adjusted 30-day mortality did not change over time, while risk-adjusted rehospitalization decreased over time and more quickly for same-day discharge (P for interaction <0.001). In the past decade, a large increase in the use of same-day discharge following elective PCI was not associated with worse 30-day mortality or rehospitalization. Hospital-level variation in same-day discharge may represent an opportunity to reduce costs without compromising patient outcomes. [Display omitted] [ABSTRACT FROM AUTHOR]
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- 2021
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24. Venous thromboembolism among patients hospitalized with COVID-19 at Veterans Health Administration Hospitals.
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Gutierrez, J. Antonio, Samsky, Marc D., Schulteis, Ryan D., Gu, Lin, Swaminathan, Rajesh V., Aday, Aaron W., and Rao, Sunil V.
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Patients with coronavirus disease 2019 (COVID-19) are at heightened risk of venous thromboembolic events (VTE), though there is no data examining when these events occur following a COVID-19 diagnosis. We therefore sought to characterize the incidence, timecourse of events, and outcomes of VTE during the COVID-19 pandemic in a national healthcare system using data from Veterans Affairs Administration. [ABSTRACT FROM AUTHOR]
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- 2021
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25. Percutaneous coronary intervention in patients with stable coronary artery disease and left ventricular systolic dysfunction: insights from the VA CART program.
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Brophy, Todd J., Warsavage, Theodore J., Hebbe, Annika L., Plomondon, Mary E., Waldo, Stephen W., Rao, Sunil V., DeVore, Adam D., Gutierrez, J. Antonio, and Swaminathan, Rajesh V.
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Background: Revascularization of ischemic cardiomyopathy by coronary artery bypass grafting has been shown to improve survival among patients with left ventricular ejection fraction (LVEF) ≤35%, but the role of percutaneous coronary intervention (PCI) in this context is incompletely described. This study sought to evaluate the effect of PCI on mortality and hospitalization among patients with stable coronary artery disease and reduced left ventricular ejection fraction.Methods: We performed a retrospective analysis comparing PCI with medical therapy among patients with ischemic cardiomyopathy in the Veterans Affairs Health Administration. Patients with angiographic evidence of 1 or more epicardial stenoses amenable to PCI and LVEF ≤35% were included in the analysis. Outcome data were determined by VA and non-VA data sources on mortality and hospital admission.Results: From 2008 through 2015, a study sample of 4,628 patients was identified, of which 1,322 patients underwent ad hoc PCI. Patients were followed to a maximum of 3 years. Propensity score weighted landmark analysis was used to evaluate the primary and secondary outcomes. The primary outcome of all-cause mortality was significantly lower in the PCI cohort compared with medical therapy (21.6% vs 30.0%, P <.001). The secondary outcome of all-cause rehospitalization or death was also lower in the PCI cohort (76.5% vs 83.8%, P <.001).Conclusions: In this retrospective analysis of patients with ischemic cardiomyopathy with coronary artery disease amenable to PCI and LVEF ≤35%, revascularization by PCI was associated with decreased all-cause mortality and decreased all-cause death or rehospitalization. [ABSTRACT FROM AUTHOR]- Published
- 2021
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26. Interventional cardiologists' perceptions of percutaneous coronary intervention quality measurement and feedback.
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Prabhu, Krishna M, Don, Creighton, Sayre, George G, Kearney, Kathleen E, Hira, Ravi S, Waldo, Stephen W, Rao, Sunil V, Au, David H, and Doll, Jacob A
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Background: Interventional cardiologists receive feedback on their clinical care from a variety of sources including registry-based quality measures, case conferences, and informal peer interactions. However, the impact of this feedback on clinical care is unclear.Methods: We interviewed interventional cardiologists regarding the use of feedback to improve their care of percutaneous coronary intervention (PCI) patients. Interviews were assessed with template analysis using deductive and inductive techniques.Results: Among 20 interventional cardiologists from private, academic, and Department of Veterans Affairs practice, 85% were male, 75% performed at least 100 PCIs annually, and 55% were in practice for 5 years or more. All reported receiving feedback on their practice, including formal quality measures and peer learning activities. Many respondents were critical of quality measure reporting, citing lack of trust in outcomes measures and poor applicability to clinical care. Some respondents reported the use of process measures such as contrast volume and fluoroscopy time for benchmarking their performance. Case conferences and informal peer feedback were perceived as timelier and more impactful on clinical care. Respondents identified facilitators of successful feedback interventions including transparent processes, respectful and reciprocal peer relationships, and integration of feedback into collective goals. Hierarchy and competitive environments inhibited useful feedback.Conclusions: Despite substantial resources dedicated to performance measurement and feedback for PCI, interventional cardiologists perceive existing quality measures to be of only modest value for improving clinical care. Catherization laboratories should seek to integrate quality measures into a holistic quality program that emphasizes peer learning, collective goals and mutual respect. [ABSTRACT FROM AUTHOR]- Published
- 2021
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27. Characteristics and Outcomes of Patients With History of CABG Undergoing Cardiac Catheterization Via the Radial Versus Femoral Approach.
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Manly, David A., Karrowni, Wassef, Rymer, Jennifer A., Kaltenbach, Lisa A., Swaminathan, Rajesh V., Messenger, John C., Abbott, J. Dawn, Seto, Arnold, Panetta, Carmelo, Brilakis, Emmanouil, Nikolakopoulos, Ilias, Gilchrist, Ian C., Kaul, Prashant, Dakik, Habib, and Rao, Sunil V.
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The aims of this study were to examine rates of radial artery access in post–coronary artery bypass grafting (CABG) patients undergoing diagnostic catherization and/or percutaneous coronary intervention (PCI), whether operators with higher procedural volumes and higher percentage radial use were more likely to perform diagnostic catherization and/or PCI via the radial approach in post-CABG patients, and clinical and procedural outcomes in post-CABG patients who undergo diagnostic catherization and/or PCI via the radial or femoral approach. There are limited data comparing outcomes of patients with prior CABG undergoing transradial or transfemoral diagnostic catheterization and/or PCI. Using the National Cardiovascular Data Registry CathPCI Registry, all diagnostic catheterizations and PCIs performed in patients with prior CABG from July 1, 2009, to March 31, 2018 (n = 1,279,058, 1,173 sites) were evaluated. Temporal trends in transradial access were examined, and mortality, bleeding, vascular complications, and procedural metrics were compared between transradial and transfemoral access. The rate of transradial access increased from 1.4% to 18.7% over the study period. Transradial access was associated with decreased mortality (adjusted odds ratio [OR]: 0.83; 95% confidence interval [CI]: 0.75 to 0.91), decreased bleeding (OR: 0.57; 95% CI: 0.51 to 0.63), decreased vascular complications (OR: 0.38; 95% CI: 0.30 to 0.47), increased PCI procedural success (OR: 1.11; 95% CI: 1.06 to 1.16; p < 0.0001), and significantly decreased contrast volume across all procedure types. Transradial access was associated with shorter fluoroscopy time for PCI-only procedures but longer fluoroscopy time for diagnostic procedures plus ad hoc PCI and diagnostic procedures only. Operators with a higher rate of transradial access in non-CABG patients were more likely to perform transradial access in patients with prior CABG. The rate of transradial artery access in patients with prior CABG undergoing diagnostic catheterization and/or PCI has increased over the past decade in the United States, and it was more often performed by operators using a transradial approach in non-CABG patients. Compared with transfemoral access, transradial access was associated with improved clinical outcomes in patients with prior CABG. [Display omitted] [ABSTRACT FROM AUTHOR]
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- 2021
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28. Sounding the alarm: Academic interventional cardiology at a crossroads.
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Klein, Lloyd W and Rao, Sunil V
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- 2021
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29. 2021 ACC Expert Consensus Decision Pathway on Same-Day Discharge After Percutaneous Coronary Intervention: A Report of the American College of Cardiology Solution Set Oversight Committee.
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Rao, Sunil V., Vidovich, Mladen I., Gilchrist, Ian C., Gulati, Rajiv, Gutierrez, J. Antonio, Hess, Connie N., Kaul, Prashant, Martinez, Sara C., Rymer, Jennifer, and Writing Committee
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PERCUTANEOUS coronary intervention , *LEGISLATIVE oversight , *CARDIAC catheterization , *MEDICAL logic , *CARDIOLOGY , *MEDICAL care , *CARDIOVASCULAR system , *POLICY sciences , *DISCHARGE planning - Published
- 2021
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30. Overcoming Obstacles in Designing and Sustaining a High-Quality Cardiovascular Procedure Environment.
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Klein, Lloyd W., Dehmer, Gregory J., Anderson, H. Vernon, and Rao, Sunil V.
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Accurate evaluation of the quality of invasive cardiology procedures requires appraisal of case selection, technical performance, and procedural and clinical outcomes. Regrettably, the medical care delivery system poses a number of obstacles to developing and sustaining a high-quality environment. The purposes of this viewpoint are to summarize the most common impediments, followed to summarize the most common impediments, followed by the optimal ways to design and sustain a quality assurance program to overcome these barriers. A 7-step program to create and implement an effective quality assurance program is outlined. [ABSTRACT FROM AUTHOR]
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- 2020
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31. Coronary revascularization and circulatory support strategies in patients with myocardial infarction, multi-vessel coronary artery disease, and cardiogenic shock: Insights from an international survey.
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Smilowitz, Nathaniel R., Galloway, Aubrey C., Ohman, E. Magnus, Rao, Sunil V., Bangalore, Sripal, Katz, Stuart D., and Hochman, Judith S.
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Cardiogenic shock (CS) complicating acute myocardial infarction (MI) is associated with high mortality. In the absence of data to support coronary revascularization beyond the infarct artery and selection of circulatory support devices or medications, clinical practice may vary substantially.
Methods: We distributed a survey to interventional cardiologists and cardiothoracic surgeons through relevant professional societies to determine contemporary coronary revascularization and circulatory support strategies for MI with CS and multi-vessel coronary artery disease (CAD).Results: A total of 143 participants completed the survey between 1/2019 and 8/2019. Overall, 55.2% of participants reported that the standard approach to coronary revascularization was single vessel PCI of the infarct related artery (IRA) with staged PCI of non-culprit lesions. Single vessel PCI of the IRA only (28.0%), emergency multi-vessel PCI (11.9%), and coronary artery bypass grafting (CABG) (4.9%) were standard approaches at some centers. A plurality of survey respondents (46.9%) believed initial PCI with staged CABG for multi-vessel CAD would be associated with the most favorable outcomes. A minority of respondents believed PCI-only strategies (23.1%) and CABG alone (6.3%) provided optimal care, and 23.1% were unsure of the best strategy. After PCI for CS, Impella (76.9%), intra-aortic balloon pump (IABP) (12.8%), and extra-corporeal membrane oxygenation (ECMO) (7.7%) were preferred. After CABG, IABP (34.3%), Impella (32.2%), and ECMO (28%) were preferred.Conclusions: This survey indicates substantial heterogeneity in clinical care in CS. There is evidence of provider uncertainty and clinical equipoise regarding the optimal management of patients with MI, multi-vessel CAD, and CS.Short Abstract: We sought to determine contemporary practice patterns of coronary revascularization and circulatory support in patients with MI, multi-vessel coronary artery disease (CAD), and cardiogenic shock. A survey was distributed to interventional cardiologists and cardiothoracic surgeons through relevant professional societies. Survey respondents identified substantial heterogeneity in clinical care and evidence of provider uncertainty and clinical equipoise regarding the optimal management of patients with MI, multi-vessel CAD, and CS. [ABSTRACT FROM AUTHOR]- Published
- 2020
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32. Radial versus femoral access for percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction: Trial sequential analysis.
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Osman, Mohammed, Saleem, Maryam, Osman, Khansa, Kheiri, Babikir, Regner, Sean, Radaideh, Qais, Moreland, Jason A., Rao, Sunil V, and Kapadia, Samir
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Background: Randomized controlled trials (RCTs) have yielded conflicting results about the impact of transradial access (TRA) versus transfemoral access (TFA) in patients with ST-segment elevation myocardial infarction (STEMI).Methods: We performed a trial sequential analysis (TSA) of RCTs comparing TRA and TFA in patients with STEMI. The outcomes of interest were 30-day mortality, major bleeding, major adverse cardiovascular events (MACE), myocardial infarction (MI), stroke, and access site complications.Results: A total of 17 studies with 11,992 patients were included in the current TSA. The TRA group had lower 30-day mortality (risk ratio [RR] 0.72, 95% CI 0.58-0.90, P = .003), major bleeding (RR 0.62, 95% CI 0.49-0.79, P = .0001), MACE (RR 0.74, 95% CI 0.58-0.93, P = .01), and access site complications (RR 0.37, 95% CI 0.28-0.48, P < .00001). There was no difference in MI and stroke between the 2groups. Applying TSA boundaries, the z-curve for 30-day mortality, major bleeding, MACE and access site complications crossed the conventional and the TSA boundaries, indicating firm evidence for better outcomes in the TRA group. For MI and stroke, the z-curve failed to cross the conventional and the TSA boundaries for both outcomes, indicating lack of signals of benefit or harm.Conclusions: In the current TSA, the available data from RCTs support improved 30-day mortality, major bleeding, MACE and access site complication rates in STEMI patients treated by PCI through the radial access. [ABSTRACT FROM AUTHOR]- Published
- 2020
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33. Safety and efficacy of antiplatelet regimens after percutaneous coronary intervention using drug eluting stents: A network meta-analysis of randomized controlled trials.
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Garg, Aakash, Rout, Amit, Sharma, Abhishek, Sargsya, Davit, Beavers, Traymon, Tantry, Udaya, Gurbe, Paul, Rao, Sunil V., Kostis, John B., Cohen, Marc, Sargsyan, Davit, and Gurbel, Paul
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Aims: We aimed to determine the efficacy and safety of different anti-platelet regimens after percutaneous coronary intervention (PCI) with drug eluting stent (DES) implantation using a network meta-analysis of randomized controlled trials (RCTs).Methods: RCTs comparing shorter duration (≤6 months) of dual antiplatelet therapy (S-DAPT) with either aspirin (ASA) or P2Y12 inhibitor monotherapy against longer duration (≥12 months) DAPT (L-DAPT) after PCI were searched in the MEDLINE, EMBASE and COCHRANE databases. End-points of interest were all-cause death, cardiovascular (CV) death, myocardial infarction (MI), stent thrombosis (ST), major bleeding and major or minor bleeding. Network meta-analyses were performed using frequentist approach.Results: Eighteen RCTs with total of 57,942 patients met the inclusion and exclusion criteria. This included 14 RCTs (N = 28,853) of S-DAPT with ASA monotherapy and 4 RCTs (N = 29,089) with P2Y12 inhibitor monotherapy. Compared with L-DAPT, the odds of MI were higher with S-DAPT with ASA monotherapy [OR 1.23; 95% CI 1.01-1.48], but not with P2Y12 inhibitor monotherapy [0.98; 0.85-1.14]. Both S-DAPT regimens lowered rates of major bleeding when compared with L-DAPT; ASA monotherapy [0.70; 0.49-1.00] and P2Y12 monotherapy [0.67; 0.45-0.98]. There were no differences in risks of all-cause or CV death between either regimen of S-DAPT and L-DAPT. However, in the acute coronary syndrome subgroup, ASA monotherapy was associated with increased risk of ST [1.55; 1.021-2.36] but P2Y12 monotherapy was not [0.93; 0.58-1.48].Conclusion: Amongst patients undergoing DES implantation, S-DAPT with P2Y12 inhibitor monotherapy reduces bleeding without increased risk of MI or ST compared with L-DAPT. Prospective trials are needed to evaluate if S-DAPT with P2Y12 monotherapy is superior to S-DAPT with ASA monotherapy for ischemic protection. [ABSTRACT FROM AUTHOR]- Published
- 2020
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34. Cardiac remodeling after large ST-elevation myocardial infarction in the current therapeutic era.
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Daubert, Melissa A., White, Jennifer A., Al-Khalidi, Hussein R., Velazquez, Eric J., Rao, Sunil V., Crowley, Anna Lisa, Zeymer, Uwe, Kasprzak, Jaroslaw D., Guetta, Victor, Krucoff, Mitchell W., and Douglas, Pamela S.
- Abstract
Background: The evolution and clinical impact of cardiac remodeling after large ST-elevation myocardial infarction (STEMI) is not well delineated in the current therapeutic era.Methods: The PRESERVATION I trial longitudinally assessed cardiac structure and function in STEMI patients receiving primary percutaneous coronary intervention (PCI). Echocardiograms were performed immediately post-PCI and at 1, 3, 6 and 12 months after STEMI. The extent of cardiac remodeling was assessed in patients with ejection fraction (EF) ≤ 40% after PCI. Patients were stratified by the presence or absence of reverse remodeling, defined as an increase in end-diastolic volume (EDV) of ≤10 mL or decrease in EDV at 1 month, and evaluated for an association with adverse events at 1 year.Results: Of the 303 patients with large STEMI enrolled in PRESERVATION I, 225 (74%) had at least moderately reduced systolic function (mean EF 32 ± 5%) immediately after primary PCI. In the following year, there were significant increases in EF and LV volumes, with the greatest magnitude of change occurring in the first month. At 1 month, 104 patients (46%) demonstrated reverse remodeling, which was associated with a significantly lower rate of death, recurrent myocardial infarction and repeat cardiovascular hospitalization at 1 year (HR 0.44; 95% CI: 0.19-0.99).Conclusion: Reduced EF after large STEMI and primary PCI is common in the current therapeutic era. The first month following primary reperfusion is a critical period during which the greatest degree of cardiac remodeling occurs. Patients demonstrating early reverse remodeling have a significantly lower rate of adverse events in the year after STEMI. [ABSTRACT FROM AUTHOR]- Published
- 2020
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35. Radial Access for Peripheral Interventions.
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Fanaroff, Alexander C., Rao, Sunil V., and Swaminathan, Rajesh V.
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Peripheral vascular intervention (PVI) improves quality of life and reduces major adverse limb events in patients with peripheral arterial disease. PVI is commonly performed via the femoral artery, and the most common adverse periprocedural event is a vascular access complication. Transradial access for PVI has the potential to reduce vascular access complications and improve patient outcomes. Further study is needed to elucidate the risks of stroke, acute kidney injury, and radiation exposure in the setting of transradial PVI. As transradial access for PVI progresses, it will be important to build the evidence base along with procedural experience. [ABSTRACT FROM AUTHOR]
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- 2020
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36. Opportunities for enhancing the care of older patients with ST-elevation myocardial infarction presenting for primary percutaneous coronary intervention: Rationale and design of the SAFE-STEMI for Seniors trial.
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Rymer, Jennifer A., Mandawat, Aditya, Abbott, J. Dawn, Cohen, Mauricio G., Davies, Justin E., Gilchrist, Ian C., Jolly, Sanjit S., Popma, Jeffrey J., Al-Khalidi, Hussein R., Rao, Sunil V., Kong, David, and Krucoff, Mitchell
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Advanced age is directly related to worse outcomes following ST-elevation myocardial infarction (STEMI) and higher complication rates from antithrombotic therapies and primary percutaneous coronary intervention (PCI). Often excluded from clinical trials, seniors presenting with STEMI remain an understudied population despite contributing to 140,000 hospital admissions annually. The SAFE-STEMI for Seniors study is a prospective, multicenter, unblinded, randomized clinical trial designed to examine the efficacy and safety of instantaneous wave-free ratio-guided complete revascularization in multivessel disease, while also investigating other components of STEMI care for patients ≥60 years including the efficacy and safety of zotarolimus-eluting stents for primary PCI and transradial PCI with the Glidesheath Slender and TR band. The SAFE-STEMI trial represents North America's first and only prospective randomized investigational device exemption study to use a Coordinated Registry Network infrastructure with collaborative partnering across industry manufacturers, promoting both efficiency and reduced cost of evidence development for regulatory decisions related to both diagnostic and therapeutic technologies in a single study design. The study has been powered to evaluate 2 independent co-primary end points in a population of older patients with STEMI: (1) third-generation drug-eluting stents for primary PCI and (2) instantaneous wave-free ratio-guided complete revascularization versus infarct-related artery-only revascularization. [ABSTRACT FROM AUTHOR]
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- 2019
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37. Same-day discharge among patients undergoing elective PCI: Insights from the VA CART Program.
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Rymer, Jennifer A., O'Donnell, Colin I., Plomondon, Mary E., Hess, Paul L., Donahue, Mark, Hebert, Paul L., Shroff, Adhir, Swaminathan, Rajesh V., Waldo, Stephen W., Seto, Arnold H., Helfrich, Christian D., and Rao, Sunil V.
- Abstract
Background: Available data suggest that same-day discharge (SDD) after elective percutaneous coronary intervention (PCI) is safe in select patients. Yet, little is known about contemporary adoption rates, safety, and costs in a universal health care system like the Veterans Affairs Health System.Methods: Using data from the Veterans Affairs Clinical Assessment Reporting and Tracking Program linked with Health Economics Resource Center data, patients undergoing elective PCI for stable angina between October 1, 2007 and Sepetember 30, 2016, were stratified by SDD versus overnight stay. We examined trends of SDD, and using 2:1 propensity matching, we assessed 30-day rates of readmission, mortality, and total costs at 30 days.Results: Of 21,261 PCIs from 67 sites, 728 were SDDs (3.9% of overall cohort). The rate of SDD increased from 1.6% in 2008 to 9.7% in 2016 (P < .001). SDD patients had lower rates of atrial fibrillation, peripheral arterial disease, and prior coronary artery bypass grafting and were treated at higher-volume centers. Thirty-day readmission and mortality did not differ significantly between the groups (readmission: 6.7% SDD vs 5.6% for overnight stay, P = .24; mortality: 0% vs. 0.07%, P = .99). The mean (SD) 30-day cost accrued by patients undergoing SDD was $23,656 ($15,480) versus $25,878 ($17,480) for an overnight stay. The accumulated median cost savings for SDD was $1503 (95% CI $738-$2,250).Conclusions: Veterans Affairs Health System has increasingly adopted SDD for elective PCI procedures, and this is associated with cost savings without an increase in readmission or mortality. Greater adoption has the potential to reduce costs without increasing adverse outcomes. [ABSTRACT FROM AUTHOR]- Published
- 2019
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38. Claims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials.
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Brennan, J. Matthew, Wruck, Lisa, Pencina, Michael J., Clare, Robert M., Lopes, Renato D., Alexander, John H., O'Brien, Sean, Krucoff, Mitchell, Rao, Sunil V., Wang, Tracy Y., Curtis, Lesley H., Newby, L. Kristin, Granger, Christopher B., Patel, Manesh, Mahaffey, Kenneth, Ross, Joseph S., Normand, Sharon-Lise, Eloff, Benjamin C., Caños, Daniel A., and Lokhnygina, Yuliya V.
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Background: Medicare insurance claims may provide an efficient means to ascertain follow-up of older participants in clinical research. We sought to determine the accuracy and completeness of claims- versus site-based follow-up with clinical event committee (+CEC) adjudication of cardiovascular outcomes.Methods: We performed a retrospective study using linked Medicare and Duke Database of Clinical Trials data. Medicare claims were linked to clinical data from 7 randomized cardiovascular clinical trials. Of 52,476 trial participants, linking resulted in 5,839 (of 10,497 linkage-eligible) Medicare-linked trial participants with fee-for-service A and B coverage. Death, myocardial infarction (MI), stroke, and revascularization incidences were compared using Medicare inpatient claims only, site-reported events (+CEC) only, or a combination of the 2. Randomized treatment effects were compared as a function of whether claims-based, site-based (+CEC), or a combined system was used for event detection.Results: Among the 5,839 study participants, the annual event rates were similar between claims- and site-based (+CEC) follow-up: death (overall rate 5.2% vs 5.2%; adjusted κ 0.99), MI (2.2% vs 2.3%; adjusted κ 0.96), stroke (0.7% vs 0.7%; adjusted κ 0.99), and any revascularization (7.4% vs 7.9%; adjusted κ 0.95). Of events detected by claims yet not reported by CEC, a minority were reported by sites but negatively adjudicated by CEC (39% of MIs and 18% of strokes). Differences in individual case concordance led to higher event rates when claims- and site-based (+CEC) systems were combined. Randomized treatment effects were similar among the 3 approaches for each outcome of interest.Conclusions: Claims- versus site-based (+CEC) follow-up identified similar overall cardiovascular event rates despite meaningful differences in the events detected. Randomized treatment effects were similar using the 2 methods, suggesting claims data could be used to support clinical research leveraging routinely collected data. This approach may lead to more effective evidence generation, synthesis, and appraisal of medical products and inform the strategic approaches toward the National Evaluation System for Health Technology. [ABSTRACT FROM AUTHOR]- Published
- 2019
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39. Stability After Initial Decline in Coronary Revascularization Rates in the United States.
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Raza, Sajjad, Deo, Salil V., Kalra, Ankur, Zia, Aisha, Altarabsheh, Salah E., Deo, Vaishali S., Mustafa, Rami R., Younes, Ahmad, Rao, Sunil V., Markowitz, Alan H., Park, Soon J., Costa, Marco A., Simon, Daniel I., Bhatt, Deepak L., and Sabik III, Joseph F.
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It remains uncertain how advances in revascularization techniques, availability of new evidence, and updated guidelines have influenced the annual rates of coronary revascularization in the United States. We used the Nationwide Inpatient Sample data from 2005 to 2014 with appropriate weighting to determine national procedural volumes. To present accurately overall percutaneous coronary intervention (PCI) rates, PCI with same-day discharge numbers per year were estimated from the available literature and added to annual PCI procedures performed. Annual PCI rate declined from 353 per 100,000 adults in 2005 to 277 per 100,000 adults in 2009 (P <.001) but remained stable thereafter (P =.50). Annual coronary artery bypass grafting (CABG) rate declined steadily, at a shallower slope than PCI, from 120 per 100,000 in 2005 to 93 per 100,000 in 2009 (P =.02) but remained stable thereafter (P =.60). Similar trends were seen in men and women. Both PCI and CABG rates were lower in women than men over the study period (PCI, 482 to 324/100,000 in men vs 232 to 153/100,000 in women; CABG, 172 to 118/100,000 in men vs 64 to 38/100,000 in women). Annual PCI rates were higher than CABG rates in patients of all age groups including in younger patients (age < 50) and octogenarians. The proportion of coronary revascularization procedures performed per insurance type remained relatively similar across the study period. Annual rates of coronary revascularization have changed significantly over time, potentially because of advances in revascularization techniques, availability of new evidence, and updated guidelines. Rates of PCI declined more steeply than CABG before plateauing but remained higher than rates of CABG across the study period. [ABSTRACT FROM AUTHOR]
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- 2019
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40. Lifting the Regulatory Blanket Off of Covered Stents.
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Rao, Sunil V. and Kandzari, David E.
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- 2023
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41. Ad hoc percutaneous coronary intervention in patients with stable coronary artery disease: A report from the National Cardiovascular Data Registry CathPCI Registry.
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Faridi, Kamil F., Rymer, Jennifer A., Rao, Sunil V., Dai, David, Wojdyla, Daniel, Yeh, Robert W., and Wang, Tracy Y.
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Percutaneous coronary intervention (PCI) may be performed in the same procedure as diagnostic coronary angiography (ad hoc PCI). This study aimed to evaluate current rates of ad hoc PCI use and associated risks of adverse outcomes in patients with stable coronary artery disease (CAD).
Methods: We identified 550,742 patients with stable CAD who underwent PCI in the National Cardiovascular Data Registry CathPCI Registry from 2009 to 2017. We compared in-hospital bleeding, acute kidney injury (AKI), and mortality between patients receiving ad hoc versus non-ad hoc PCI using logistic regression with inverse probability weighted propensity adjustment.Results: Between 2009 and 2017, 82.9% of patients underwent ad hoc PCI. Patients who did not undergo ad hoc PCI had higher prevalence of peripheral vascular disease, heart failure, chronic kidney disease, and coronary artery bypass graft. Ad hoc PCI was associated with lower bleeding risk (adjusted odds ratio [aOR] 0.83, 95% CI 0.79-0.87) but no differences in risks of AKI (aOR 0.95, 95% CI 0.90-1.00) or mortality (aOR 1.09, 95% CI 0.97-1.23) compared with non-ad hoc PCI. Ad hoc PCI was associated with AKI risk in patients with glomerular filtration rate <30 mL/min (interaction P < .001), mortality risk in multivessel PCI (interaction P = .031), and risks of AKI and mortality in PCI of chronic total occlusions (interaction P = .045 and .002, respectively).Conclusions: Ad hoc PCI is extremely common among US patients with stable CAD and is associated with lower bleeding risk but no differences in risks of AKI or mortality compared with non-ad hoc PCI. [ABSTRACT FROM AUTHOR]- Published
- 2019
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42. The OPTIMIZE randomized trial to assess safety and efficacy of the Svelte IDS and RX Sirolimus-eluting coronary stent Systems for the Treatment of atherosclerotic lesions: Trial design and rationale.
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Mauri, Laura, Doros, Gheorghe, Rao, Sunil V., Cohen, David J., Yakubov, Steven, Lasala, John, Wong, S. Chiu, Zidar, James, and Kereiakes, Dean J.
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Coronary stenting without angioplasty pretreatment (direct stenting) may simplify procedures in appropriate lesions. Direct stenting is facilitated by smaller profile coronary stent platforms. The present study was designed for regulatory approval of a novel drug-eluting coronary stent and incorporates both randomized comparison for non-inferiority to an approved predicate device as well as a nested evaluation of subjects eligible for direct stenting. STUDY DESIGN AND OBJECTIVES: Prospective, single-blind, randomized, active-control, multi-center study designed to assess the safety and efficacy of the novel Svelte sirolimus-eluting stent (SES) systems. A total of 1630 subjects with up to 3 target lesions will be randomized 1:1 to the Svelte SES versus either the Xience or Promus everolimus-eluting stents (control). Randomization will be stratified by whether or not a direct stenting strategy is planned by the investigator. The primary endpoint is target lesion failure (TLF) at 12 months post index procedure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization, and the primary analysis is a non-inferiority test with a non-inferiority margin of 3.58%. Secondary clinical endpoints include individual components of TLF, stent thrombosis and measures of procedural resource utilization including contrast administration, fluoroscopy exposure and procedural resource utilization as well as costs. CONCLUSION: The OPTMIZE Trial will evaluate the safety, efficacy and clinical value of the novel Svelte SES in subjects with up to 3 lesions, and will provide a comparison of direct stenting between randomized devices. [ABSTRACT FROM AUTHOR]
- Published
- 2019
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43. Risk of obstructive coronary artery disease and major adverse cardiac events in patients with noncoronary atherosclerosis: Insights from the Veterans Affairs Clinical Assessment, Reporting, and Tracking (CART) Program.
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Gutierrez, J. Antonio, Bhatt, Deepak L., Banerjee, Subhash, Glorioso, Thomas J., Josey, Kevin P., Swaminathan, Rajesh V., Maddox, Thomas M., Armstrong, Ehrin J., Duvernoy, Claire, Waldo, Stephen W., and Rao, Sunil V.
- Abstract
We sought to determine the risk of obstructive coronary artery disease (oCAD) associated with noncoronary atherosclerosis (cerebrovascular disease [CVD] or peripheral arterial disease [PAD]) and major adverse cardiac events following percutaneous coronary intervention (PCI).
Methods: Rates of the angiographic end point of oCAD were compared among patients with and without noncoronary atherosclerosis undergoing coronary angiography within the Veterans Health Administration between October 2007 and August 2015. The primary angiographic end point of oCAD was defined as left main stenosis ≥50% or any stenosis ≥70% in 1, 2, or 3 vessels. In patients who proceeded to PCI, the rate of the composite clinical end point of death, myocardial infarction, or stroke was compared among those with concomitant noncoronary atherosclerosis (CVD, PAD, or CVD + PAD) versus isolated CAD.Results: Among 233,353 patients undergoing angiography, 9.6% had CVD, 12.4% had PAD, and 6.1% had CVD + PAD. Rates of oCAD were 57.9% for neither CVD nor PAD, 66.4% for CVD, 73.6% for PAD, and 80.9% for CVD + PAD. Compared with patients without noncoronary atherosclerosis, the adjusted risk of oCAD with CVD, PAD, or CVD + PAD was 1.03 (95% CI 1.02-1.04), 1.10 (95% CI 1.09-1.11), and 1.12 (95% CI 1.11-1.13), respectively. In patients who underwent PCI, the adjusted hazard for death, myocardial infarction, or stroke among those with CVD, PAD, or CVD + PAD was 1.36 (95% CI 1.26-1.45), 1.53 (95% CI 1.45-1.62), and 1.72 (95% CI 1.59-1.86), respectively.Conclusions: In patients undergoing coronary angiography, noncoronary atherosclerosis was associated with increased burden of oCAD and adverse events post-PCI. [ABSTRACT FROM AUTHOR]- Published
- 2019
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44. Age, STEMI, and Cardiogenic Shock: Never Too Old for PCI?
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Navarese, Eliano P, Rao, Sunil V, and Krucoff, Mitchell W
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- 2019
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45. Reply: Distal Transradial Access in Acute Coronary SyndromesShould We Give the First Try?
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Ferrante, Giuseppe, Rao, Sunil V., and Valgimigli, Marco
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- 2023
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46. Validation of the Academic Research Consortium Definition of High Bleeding Risk: Not Academic Anymore.
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Rao, Sunil V and Wegermann, Zachary K
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- 2020
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47. Ultrasound-guided versus palpation-guided radial artery catheterization in adult population: A systematic review and meta-analysis of randomized controlled trials.
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Moussa Pacha, Homam, Alahdab, Fares, Al-khadra, Yasser, Idris, Amr, Rabbat, Firas, Darmoch, Fahed, Soud, Mohamad, Zaitoun, Anwar, Kaki, Amir, Rao, Sunil V., Kwok, Chun Shing, Mamas, Mamas A., and Alraies, M. Chadi
- Abstract
Background: The radial artery (RA) is routinely used for both hemodynamic monitoring and for cardiac catheterization. Although cannulation of the RA is usually undertaken through manual palpation, ultrasound (US)-guided access has been advocated as a mean to increase cannulation success rates and to lower RA complications; however, the published data are mixed. We sought to evaluate the impact of US-guided RA access compared with palpation alone on first-pass success to access RA.Methods and Results: Meta-analysis of 12 randomized controlled trials comparing US-guided with palpation-guided radial access in 2,432 adult participants was done. Hemodynamic monitoring was the most common reason for RA catheterization. Only 2 randomized controlled trials evaluated patients undergoing cardiac catheterization. Ultrasound-guided radial access was associated with increased first-attempt success rate (risk ratio [RR] 1.35, 95% CI 1.16-1.57]) and decreased failure rate (RR 0.52, 95% CI 0.32-0.87). There were no significant differences in the risk of hematoma (RR 0.43, 95% CI 0.27-1.06), the mean time to first successful attempt (mean difference 25.13 seconds, 95% CI -1.06 to 51.34) or to any successful attempt (mean difference -4.74 seconds; 95% CI -22.67 to 13.18) between both groups.Conclusions: Ultrasound-guided technique for RA access has higher first-attempt success and lower failure rate compared with palpation alone, with no significant differences in access site hematoma or time to a successful attempt. These findings support the routine use of US guidance for RA access. [ABSTRACT FROM AUTHOR]- Published
- 2018
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48. Clinical trials evaluating red blood cell transfusion thresholds: An updated systematic review and with additional focus on patients with cardiovascular disease.
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Carson, Jeffrey L, Stanworth, Simon J, Alexander, John H., Roubinian, Nareg, Fergusson, Dean A, Triulzi, Darrell J, Goodman, Shaun G, Rao, Sunil V., Doree, Carolyn, and Hebert, Paul C
- Abstract
Background: Several new trials evaluating transfusion strategies in patients with cardiovascular disease have recently been published, increasing the number of enrolled patients by over 30%. The objective was to evaluate transfusion thresholds in patients with cardiovascular disease.Methods: We conducted an updated systematic review of randomized trials that compared patients assigned to maintain a lower (restrictive transfusion strategy) or higher (liberal transfusion strategy) hemoglobin concentration. We focused on new trial data in patients with cardiovascular disease. The primary outcome was 30-day mortality. Specific subgroups were patients undergoing cardiac surgery and with acute myocardial infarction.Results: A total of 37 trials that enrolled 19,049 patients were appraised. In cardiac surgery, mortality at 30days was comparable between groups (risk ratio 0.99; 95% confidence interval 0.74-1.33). In 2 small trials (n=154) in patients with myocardial infarction, the point estimate for the mortality risk ratio was 3.88 (95% CI, 0.83-18.13) favoring the liberal strategy. Overall, from 26 trials enrolling 15,681 patients, 30-day mortality was not different between restrictive and liberal transfusion strategies (risk ratio 1.0, 95% CI, 0.86-1.16). Overall and in the cardiovascular disease subgroup, there were no significant differences observed across a range of secondary outcomes.Conclusions: New trials in patients undergoing cardiac surgery establish that a restrictive transfusion strategy of 7 to 8g/dL is safe and decreased red cell use by 24%. Further research is needed to define the optimal transfusion threshold in patients with acute myocardial infarction. [ABSTRACT FROM AUTHOR]- Published
- 2018
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49. Appropriateness and Outcomes of Percutaneous Coronary Intervention at Top-Ranked and Nonranked Hospitals in the United States.
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Sukul, Devraj, Bhatt, Deepak L., Seth, Milan, Zakroysky, Pearl, Wojdyla, Daniel, Rumsfeld, John S., Wang, Tracy, Rao, Sunil V., and Gurm, Hitinder S.
- Abstract
Objectives This study sought to compare the appropriate use and outcomes of percutaneous coronary intervention (PCI) between top-ranked and nonranked hospitals. Background The U.S. News & World Report “Best Hospitals” rankings are an influential consumer-directed publication of hospital quality, and are commonly used in promotional campaigns by hospital systems. Methods Hospitals in the National Cardiovascular Data Registry CathPCI registry between July 1, 2014, and June 30, 2015, were classified as top-ranked if they were included in the 2015 U.S. News & World Report 50 best “Cardiology and Heart Surgery” hospitals. The remaining were classified as nonranked. We compared in-hospital mortality, post-procedural bleeding, post-procedural acute kidney injury, and the proportion of appropriate PCI procedures between top-ranked and nonranked hospitals. Results A total of 509,153 PCIs at 654 hospitals were included, of which 55,550 (10.9%) were performed at 44 top-ranked hospitals. After adjusting for patient case mix, PCIs performed at top-ranked hospitals had similar odds of in-hospital mortality (adjusted odds ratio [aOR]: 0.96; 95% confidence interval [CI]: 0.83 to 1.12; p = 0.64), acute kidney injury (aOR: 1.10; 95% CI: 0.98 to 1.22; p = 0.099), and bleeding (aOR: 1.15; 95% CI: 0.99 to 1.31; p = 0.052). Top-ranked hospitals had a slightly lower proportion of appropriate PCI compared with nonranked hospitals (89.2% vs. 92.8%; OR: 0.56; 95% CI: 0.45 to 0.69; p < 0.001). Conclusions PCI performed at top-ranked hospitals was not associated with superior outcomes compared with PCI at nonranked hospitals. The inclusion of metrics based on clinical data may be important for hospital quality rankings. [ABSTRACT FROM AUTHOR]
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- 2018
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50. Variation in the Adoption of Transradial Access for ST-Segment Elevation Myocardial Infarction: Insights From the NCDR CathPCI Registry.
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Valle, Javier A., Kaltenbach, Lisa A., Bradley, Steven M., Yeh, Robert W., Rao, Sunil V., Gurm, Hitinder S., Armstrong, Ehrin J., Messenger, John C., and Waldo, Stephen W.
- Abstract
Objectives The study sought to define patient, operator, and institutional factors associated with transradial access (TRA) in ST-segment elevation myocardial infarction (STEMI) percutaneous coronary intervention (PCI), the variation in use across operators and institutions, and the relationship with mortality and bleeding. Background TRA for PCI in STEMI is underutilized. Factors associated with TRA are not well described, nor is there variation across operators and institutions or their relationship with outcomes. Methods The authors used hierarchical logistic regression to identify patient, operator, and institutional characteristics associated with TRA use as well as determine the variation in TRA for STEMI PCI from 2009 to 2015. They also described the relationship between operator- and institution-level use and risk-adjusted bleeding and mortality. Results Among 692,433 patients undergoing STEMI PCI, 12% (n = 82,618) utilized TRA. TRA increased from 2% to 23% from 2009 to 2015, but with significant geographic variation. Age, sex, cardiogenic shock, cardiac arrest, operators entering practice before 2012, and nonacademically affiliated institutions were associated with lower rates of TRA. There was significant operator and institutional variation, wherein identical patients would have >8-fold difference in odds of TRA for STEMI PCI by changing operators (median odds ratio: 8.7), and >5-fold difference by changing institutions (median odds ratio: 5.1). Greater TRA use across operators was associated with reduced bleeding (rho = −0.053), whereas TRA use across institutions was associated with reduced mortality (rho = −0.077). Conclusions Transradial access for STEMI PCI is increasing, but remains underutilized with significant geographic, operator, and institutional variation. These findings suggest an ongoing opportunity to standardize STEMI care. [ABSTRACT FROM AUTHOR]
- Published
- 2017
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