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The Future of Circulation: Cardiovascular Interventions: Changing, Creating, and Maturing [Editorial]

Rao, Sunil V
PMID: 30002091
ISSN: 1941-7632
CID: 5221922

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

Ultrasound-guided versus palpation-guided radial artery catheterization in adult population: A systematic review and meta-analysis of randomized controlled trials

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; Alraies, M Chadi
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.
PMID: 30077047
ISSN: 1097-6744
CID: 5221942

Cardiac allograft vasculopathy: A review

Lee, Michael S; Tadwalkar, Rigved V; Fearon, William F; Kirtane, Ajay J; Patel, Amisha J; Patel, Chetan B; Ali, Ziad; Rao, Sunil V
Cardiac allograft vasculopathy (CAV) is a complex disease that remains a significant cause of morbidity and mortality after orthotopic heart transplantation (OHT). Originating as a result of inflammatory response, the development and progression of CAV is attributed to endothelial dysfunction, cellular infiltration, and a wide-range of genetic and patient factors. The detection of CAV remains a diagnostic challenge, as symptoms can be variable or absent. While coronary angiography remains the initial test of choice for the diagnosis and surveillance of CAV, intravascular imaging (either by ultrasound or optical coherence tomography) and physiologic assessments are useful adjuncts in the cardiac catheterization laboratory. Positron emission tomography, computed tomographic, and magnetic resonance imaging may have a role increasing the time interval between invasive screening tests for prognosis. Medical management should include a statin, vasodilator, and tailored immunosuppressive regimen that maximally decrease allograft rejection and CAV progression while causing minimal side effects. Patients that are less responsive to pharmacotherapy should be considered for invasive management with percutaneous coronary intervention. Although surgical revascularization is a poor option, repeat OHT is the only definitive treatment option but given its morbidity should be reserved for a highly selected patient population.
PMID: 30265435
ISSN: 1522-726x
CID: 5221992

Two-year mortality of primary angioplasty for acute myocardial infarction during regular working hours versus off-hours

Dharma, Surya; Dakota, Iwan; Sukmawan, Renan; Andriantoro, Hananto; Siswanto, Bambang Budi; Rao, Sunil V
BACKGROUND:Studies with short-term follow-up found higher mortality in patients with STEMI who underwent primary PCI during off-hours as compared to regular working hours. We analyzed the interaction between one and two-year survival of patients with STEMI who underwent primary PCI during regular working hours and off-hours in a tertiary care academic teaching hospital. METHODS:A total of 1126 STEMI patients treated with primary PCI between 2008 and 2013 were analyzed. Two-years follow-up were available in 941 (83%) patients. Multivariable survival analysis was used to estimate the relationship between treatment during off-hours versus regular hours and the incidence of all-cause mortality at 2-years follow-up. Logistic regression was used to calculate interaction p-values between time of admission and time (between ≤1 year and ≤2 year). RESULTS:At 2-years, the mortality rate of patients admitted during off-hours and regular hours was similar (15% vs. 19%; adjusted hazard ratio 0.77; 95% confidence interval 0.52-1.16). Of the 941 patients, those who admitted during off-hours (N = 717) had similar median door-to-device time (94 min vs. 91 min), final Thrombolysis In Myocardial Infarction 3 flow grade (93% vs. 91%) and use of dual antiplatelet within 24 h (96% vs. 98% respectively) as compared with regular hours admission (N = 224). There were no mortality difference observed between one year and two years (p interaction >0.05). CONCLUSION:In this analysis, the similar mortality observed at one year between patients with STEMI treated by primary PCI during off-hour and regular hour were maintained at two years.
PMID: 29730236
ISSN: 1878-0938
CID: 5221872

Associations Between Complex PCI and Prasugrel or Clopidogrel Use in Patients With Acute Coronary Syndrome Who Undergo PCI: From the PROMETHEUS Study

Chandrasekhar, Jaya; Baber, Usman; Sartori, Samantha; Aquino, Melissa; Kini, Annapoorna S; Rao, Sunil; Weintraub, William; Henry, Timothy D; Farhan, Serdar; Vogel, Birgit; Sorrentino, Sabato; Ge, Zhen; Kapadia, Samir; Muhlestein, Joseph B; Weiss, Sandra; Strauss, Craig; Toma, Catalin; DeFranco, Anthony; Effron, Mark B; Keller, Stuart; Baker, Brian A; Pocock, Stuart; Dangas, George; Mehran, Roxana
BACKGROUND:inhibitors might offer enhanced benefit against thrombotic events in complex percutaneous coronary intervention (PCI). We examined prasugrel use and outcomes according to PCI complexity, as well as analyzing treatment effects according to thienopyridine type. METHODS:PROMETHEUS was a multicentre observational study that compared clopidogrel vs prasugrel in acute coronary syndrome patients who underwent PCI (n = 19,914). Complex PCI was defined as PCI of the left main, bifurcation lesion, moderate-severely calcified lesion, or total stent length ≥ 30 mm. Major adverse cardiac events (MACE) were a composite of death, myocardial infarction, stroke, or unplanned revascularization. Outcomes were adjusted using multivariable Cox regression for effect of PCI complexity and propensity-stratified analysis for effect of thienopyridine type. RESULTS:The study cohort included 48.9% (n = 9735) complex and 51.1% (n = 10,179) noncomplex patients. Second generation drug-eluting stents were used in 70.1% complex and 66.2% noncomplex PCI patients (P < 0.0001). Complex PCI was associated with greater adjusted risk of 1-year MACE (hazard ratio [HR], 1.29; 95% confidence interval [CI], 1.20-1.39; P < 0.001). Prasugrel was prescribed in 20.7% of complex and 20.1% of noncomplex PCI patients (P = 0.30). Compared with clopidogrel, prasugrel significantly decreased adjusted risk for 1-year MACE in complex PCI (HR, 0.79; 95% CI, 0.68-0.92) but not noncomplex PCI (HR, 0.91; 95% CI, 0.77-1.08), albeit there was no evidence of interaction (P interaction = 0.281). CONCLUSIONS:Despite the use of contemporary techniques, acute coronary syndrome patients who undergo complex PCI had significantly higher rates of 1-year MACE. Adjusted magnitude of treatment effects with prasugrel vs clopidogrel were consistent in complex and noncomplex PCI without evidence of interaction.
PMID: 29475531
ISSN: 1916-7075
CID: 2991192

Comparison of Radial Access, Guided Femoral Access, and Non-Guided Femoral Access Among Women Undergoing Percutaneous Coronary Intervention

Koshy, Linda M; Aberle, Laura H; Krucoff, Mitchell W; Hess, Connie N; Mazzaferri, Ernest; Jolly, Sanjit S; Jacobs, Alice; Gibson, C Michael; Mehran, Roxana; Gilchrist, Ian C; Rao, Sunil V
OBJECTIVES:This study was conducted to determine the association between radial access, guided femoral access, and non-guided femoral access on postprocedural bleeding and vascular complications after percutaneous coronary intervention (PCI). BACKGROUND:Bleeding events and major vascular complications after PCI are associated with increased morbidity, mortality, and cost. While the radial approach has been shown to be superior to the femoral approach in reducing bleeding and vascular complications, whether the use of micropuncture, fluoroscopy, or ultrasound mitigates these differences is unknown. METHODS:We conducted a post hoc analysis of women in the SAFE-PCI for Women trial who underwent PCI and had the access method identified (n = 643). The primary endpoint of postprocedure bleeding or vascular complications occurring within 72 hours or at discharge was adjudicated by an independent clinical events committee and was compared based on three categories of access technique: radial, guided femoral (fluoroscopy, micropuncture, ultrasound), or non-guided femoral (none of the aforementioned). Differences between the groups were determined using multivariate logistic regression using radial access as the reference. RESULTS:Of the PCI population, 330 underwent radial access, 228 underwent guided femoral access, and 85 underwent non-guided femoral access. There was a statistically significant lower incidence of the primary endpoint with radial access vs non-guided femoral access; however, there was no significant difference between radial approach and femoral access guided by fluoroscopy, micropuncture, or ultrasound. CONCLUSIONS:This post hoc analysis demonstrates that while radial access is safer than non-guided femoral access, guided femoral access appears to be associated with similar bleeding events or vascular complications as radial access.
PMID: 29035844
ISSN: 1557-2501
CID: 2985222

Sex-related differences in outcomes among men and women under 55 years of age with acute coronary syndrome undergoing percutaneous coronary intervention: Results from the PROMETHEUS study

Chandrasekhar, Jaya; Baber, Usman; Sartori, Samantha; Faggioni, Michela; Aquino, Melissa; Kini, Annapoorna; Weintraub, William; Rao, Sunil; Kapadia, Samir; Weiss, Sandra; Strauss, Craig; Toma, Catalin; Muhlestein, Brent; DeFranco, Anthony; Effron, Mark; Keller, Stuart; Baker, Brian; Pocock, Stuart; Henry, Timothy; Mehran, Roxana
BACKGROUND:Young women undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) experience greater adverse events than men, potentially due to under-treatment. We sought to compare the 1-year outcomes by sex in patients ≤55 years of age from a contemporary PCI cohort. METHODS:PROMETHEUS was a retrospective multicenter observational US study comparing outcomes in clopidogrel and prasugrel treated patients following ACS PCI. MACE was defined as a composite of death, myocardial infarction, stroke or unplanned revascularization. Clinically significant bleeding was defined as bleeding requiring transfusion or hospitalization. Hazard ratios were generated using multivariable Cox proportional hazards regression. RESULTS:The study cohort included 4,851 patients of which 1,162 (24.0%) were women and 3,689 (76.0%) were men. In this cohort, the prevalence of diabetes (41.0 vs. 27.9%) and chronic kidney disease (12.7 vs. 7.2%) was higher among women compared with men. Irrespective of sex, prasugrel was used in less than one-third of patients (31.8% in men vs. 28.1% in women, P = 0.01). Unadjusted, 1-year MACE (21.1% vs. 16.2%, P < 0.001) and bleeding (3.6% vs. 2.2%, P = 0.01) was significantly higher in women compared with men, but these results were no longer significant after adjustment for risk (HR 1.13, 95% CI 0.94-1.36 for MACE and HR 1.31, 95% CI 0.85-2.04 for bleeding). CONCLUSION/CONCLUSIONS:Women ≤ 55 years of age undergoing ACS PCI have significantly greater comorbidities than young men. Despite a higher risk clinical phenotype in women, prasugrel use was significantly lower in women than men. Female sex was associated with a significantly higher risk of 1-year MACE and bleeding than male sex, findings that are attributable to baseline differences. © 2016 Wiley Periodicals, Inc.
PMID: 27152497
ISSN: 1522-726x
CID: 5490612

Associations Between Chronic Kidney Disease and Outcomes With Use of Prasugrel Versus Clopidogrel in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: A Report From the PROMETHEUS Study

Baber, Usman; Chandrasekhar, Jaya; Sartori, Samantha; Aquino, Melissa; Kini, Annapoorna S; Kapadia, Samir; Weintraub, William; Muhlestein, Joseph B; Vogel, Birgit; Faggioni, Michela; Farhan, Serdar; Weiss, Sandra; Strauss, Craig; Toma, Catalin; DeFranco, Anthony; Baker, Brian A; Keller, Stuart; Effron, Mark B; Henry, Timothy D; Rao, Sunil; Pocock, Stuart; Dangas, George; Mehran, Roxana
OBJECTIVES:This study sought to compare clinical outcomes in a contemporary acute coronary syndrome (ACS) percutaneous coronary intervention (PCI) cohort stratified by chronic kidney disease (CKD) status. BACKGROUND:Patients with CKD exhibit high risks for both thrombotic and bleeding events, thus complicating decision making regarding antiplatelet therapy in the setting of ACS. METHODS:The PROMETHEUS study was a multicenter observational study comparing outcomes with prasugrel versus clopidogrel in ACS PCI patients. Major adverse cardiac events (MACE) at 90 days and at 1 year were defined as a composite of death, myocardial infarction, stroke, or unplanned revascularization. Clinically significant bleeding was defined as bleeding requiring transfusion or hospitalization. Cox regression multivariable analysis was performed for adjusted associations between CKD status and clinical outcomes. Hazard ratios for prasugrel versus clopidogrel treatment were generated using propensity score stratification. RESULTS:The total cohort included 19,832 patients, 28.3% with and 71.7% without CKD. CKD patients were older with greater comorbidities including diabetes and multivessel disease. Prasugrel was less often prescribed to CKD versus non-CKD patients (11.0% vs. 24.0%, respectively; p < 0.001). At 1 year, CKD was associated with higher adjusted risk of MACE (1.27; 95% confidence interval: 1.18 to 1.37) and bleeding (1.46; 95% confidence interval: 1.24 to 1.73). Although unadjusted rates of 1-year MACE were lower with prasugrel versus clopidogrel in both CKD (18.3% vs. 26.5%; p < 0.001) and non-CKD (10.9% vs. 17.9%; p < 0.001) patients, associations were attenuated after propensity stratification. Similarly, unadjusted differences in 1-year bleeding with prasugrel versus clopidogrel (6.0% vs. 7.4%; p = 0.18 in CKD patients; 2.6% vs. 3.5%; p = 0.008 in non-CKD patients) were not significant after propensity score adjustment. CONCLUSIONS:Although risks for 1-year MACE were significantly higher in ACS PCI patients with versus without CKD, prasugrel use was 50% lower in patients with renal impairment. Irrespective of CKD status, outcomes associated with prasugrel use were not significant after propensity adjustment. These data highlight the need for randomized studies evaluating the optimal antiplatelet therapy in CKD patients with ACS.
PMID: 28780028
ISSN: 1876-7605
CID: 5491092

Use of prasugrel vs clopidogrel and outcomes in patients with acute coronary syndrome undergoing percutaneous coronary intervention in contemporary clinical practice: Results from the PROMETHEUS study

Baber, Usman; Sartori, Samantha; Aquino, Melissa; Kini, Annapoorna; Kapadia, Samir; Weiss, Sandra; Strauss, Craig; Muhlestein, J Brent; Toma, Catalin; Rao, Sunil V; DeFranco, Anthony; Poddar, Kanhaiya L; Chandrasekhar, Jaya; Weintraub, William; Henry, Timothy D; Bansilal, Sameer; Baker, Brian A; Marrett, Elizabeth; Keller, Stuart; Effron, Mark; Pocock, Stuart; Mehran, Roxana
BACKGROUND AND OBJECTIVES/OBJECTIVE:We sought to determine the frequency of use and association between prasugrel and outcomes in acute coronary syndrome patients undergoing percutaneous coronary intervention (PCI) in clinical practice. METHODS:PROMETHEUS was a multicenter observational registry of acute coronary syndrome patients undergoing PCI from 8 centers in the United States that maintained a prospective PCI registry for patient outcomes. The primary end points were major adverse cardiovascular events at 90days, a composite of all-cause death, nonfatal myocardial infarction, stroke, or unplanned revascularization. Major bleeding was defined as any bleeding requiring hospitalization or blood transfusion. Hazard ratios (HRs) were generated using multivariable Cox regression and stratified by the propensity to treat with prasugrel. RESULTS:Of 19,914 patients (mean age 64.4years, 32% female), 4,058 received prasugrel (20%) and 15,856 received clopidogrel (80%). Prasugrel-treated patients were younger with fewer comorbid risk factors compared with their counterparts receiving clopidogrel. At 90days, there was a significant association between prasugrel use and lower major adverse cardiovascular event (5.7% vs 9.6%, HR 0.58, 95% CI 0.50-0.67, P<.0001) and bleeding (1.9% vs 2.9%, HR 0.65, 95% CI 0.51-0.83, P<.001). After propensity stratification, associations were attenuated and no longer significant for either outcome. Results remained consistent using different approaches to adjusting for potential confounders. CONCLUSIONS:In contemporary clinical practice, patients receiving prasugrel tend to have a lower-risk profile compared with those receiving clopidogrel. The lower ischemic and bleeding events associated with prasugrel use were no longer evident after accounting for these baseline differences.
PMID: 28577683
ISSN: 1097-6744
CID: 5225122