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Sex Differences in Treatment and Outcomes in Non-ST-Elevation Acute Coronary Syndrome: A Persistent Disparity [Editorial]

Siller-Matula, Jolanta M; Shah, Binita
PMID: 33430605
ISSN: 1941-7632
CID: 4798612

Anti-inflammatory therapy for COVID-19 infection: the case for colchicine

Reyes, Aaron Z; Hu, Kelly A; Teperman, Jacob; Wampler Muskardin, Theresa L; Tardif, Jean-Claude; Shah, Binita; Pillinger, Michael H
The search for effective COVID-19 management strategies continues to evolve. Current understanding of SARS-CoV-2 mechanisms suggests a central role for exaggerated activation of the innate immune system as an important contributor to COVID-19 adverse outcomes. The actions of colchicine, one of the oldest anti-inflammatory therapeutics, target multiple mechanisms associated with COVID-19 excessive inflammation. While many COVID-19 trials have sought to manipulate SARS-CoV-2 or dampen the inflammatory response once patients are hospitalised, few examine therapeutics to prevent the need for hospitalisation. Colchicine is easily administered, generally well tolerated and inexpensive, and holds particular promise to reduce the risk of hospitalisation and mortality due to COVID-19 in the outpatient setting. Successful outpatient treatment of COVID-19 could greatly reduce morbidity, mortality and the demand for rare or expensive care resources (front-line healthcare workers, hospital beds, ventilators, biological therapies), to the benefit of both resource-replete and resource-poor regions.
PMID: 33293273
ISSN: 1468-2060
CID: 4708902

Long-term outcomes after transcatheter aortic valve replacement with minimal contrast in chronic kidney disease

Rzucidlo, Justyna; Jaspan, Vita; Paone, Darien; Jilaihawi, Hasan; Xia, Yuhe; Kapitman, Anna; Nakashima, Makoto; He, Yuxin; Ibrahim, Homam; Pushkar, Illya; Neuburger, Peter J; Saric, Muhamed; Bamira, Daniel; Paschke, Sonja; Kalish, Chloe; Staniloae, Cezar; Shah, Binita; Williams, Mathew
BACKGROUND:Patients with renal insufficiency have poor short-term outcomes after transcatheter aortic valve replacement (TAVR). METHODS:Retrospective chart review identified 575 consecutive patients not on hemodialysis who underwent TAVR between September 2014 and January 2017. Outcomes were defined by VARC-2 criteria. Primary outcome of all-cause mortality was evaluated at a median follow-up of 811 days (interquartile range 125-1,151). RESULTS:Preprocedural glomerular filtration rate (GFR) was ≥60 ml/min in 51.7%, 30-60 ml/min in 42.1%, and < 30 ml/min in 6.3%. Use of transfemoral access (98.8%) and achieved device success (91.0%) did not differ among groups, but less contrast was used with lower GFR (23 ml [15-33], 24 ml [14-33], 13 ml [8-20]; p < .001). Peri-procedural stroke (0.7%, 2.1%, 11.1%; p < .001) was higher with lower GFR. Core lab analysis of preprocedural computed tomography scans of patients who developed a peri-procedural stroke identified potential anatomic substrate for stroke in three out of four patients with GFR 30-60 ml/min and all three with GFR <30 ml/min (severe atheroma was the most common subtype of anatomical substrate present). Compared to GFR ≥60 ml/min, all-cause mortality was higher with GFR 30-60 ml/min (HR 1.61 [1.00-2.59]; aHR 1.61 [0.91-2.83]) and GFR <30 ml/min (HR 2.41 [1.06-5.48]; aHR 2.34 [0.90-6.09]) but not significant after multivariable adjustment. Follow-up echocardiographic data, available in 63%, demonstrated no difference in structural heart valve deterioration over time among groups. CONCLUSIONS:Patients with baseline renal insufficiency remain a challenging population with poor long-term outcomes despite procedural optimization with a transfemoral-first and an extremely low-contrast approach.
PMID: 33180381
ISSN: 1522-726x
CID: 4665422

Colchicine Use and Incident Coronary Artery Disease in Male Patients with Gout

Shah, Binita; Toprover, Michael; Crittenden, Daria B; Jeurling, Susanna; Pike, V Courtney; Krasnokutsky, Svetlana; Xia, Yuhe; Fisher, Mark C; Slobodnick, Anastasia; Tenner, Craig T; Katz, Stuart D; Pillinger, Michael H
BACKGROUND:Inflammation is associated with coronary artery disease (CAD) and myocardial infarction (MI). Patients with gout are at increased risk of MI, and colchicine is associated with a reduced risk of MI. The objective of this study was to determine whether colchicine prevents incident development of CAD in patients with gout. METHODS:This retrospective study followed a cohort of male gout patients without known CAD at the time of gout diagnosis in the VA New York Harbor Healthcare System. The association between colchicine use and development of incident CAD, defined as evidence of ischemia or obstructive CAD on stress test or angiography, was determined using an inverse probability weighted (IPW) cox proportional hazard model. RESULTS:Among 178,877 patients, 1,638 met gout criteria, of whom 722 patients without known CAD at baseline (446 colchicine users and 276 non-users) were followed for a median of 96 months [57-117]. A trend toward association between colchicine use and reduced incident CAD was observed but not statistically significant (IPW HR 0.49 [0.23-1.05]). In patients without chronic kidney disease, colchicine use was associated with a lower rate of incident CAD (interaction p=0.005, IPW HR 0.31 [0.14-0.70]). Colchicine was also associated with a lower rate of the composite of incident CAD and MI (IPW HR 0.37 [0.16-0.83]). CONCLUSIONS:In male patients with gout and no known CAD, a trend of reduced incident CAD was observed with colchicine use that was not statistically significant. Larger, prospective studies will be required to definitively assess the primary prevention benefit of colchicine.
PMID: 32454073
ISSN: 1916-7075
CID: 4451692

SCAI Position Statement on the Performance of Percutaneous Coronary Intervention in Ambulatory Surgical Centers

Box, Lyndon C; Blankenship, James C; Henry, Timothy D; Messenger, John C; Cigarroa, Joaquin E; Moussa, Issam D; Snyder, Richard W; Duffy, Peter L; Carr, Jeffrey G; Tukaye, Deepali N; Ang, Lawrence; Shah, Binita; Rao, Sunil V; Mahmud, Ehtisham
The Centers for Medicare and Medicaid Services (CMS) began reimbursement for percutaneous coronary intervention (PCI) performed in ambulatory surgical centers (ASC) in January 2020. The ability to perform PCI in an ASC has been made possible due to the outcomes data from observational studies and randomized controlled trials supporting same day discharge (SDD) after PCI. In appropriately selected patients for outpatient PCI, clinical outcomes for SDD or routine overnight observation are comparable without any difference in short-term or long-term adverse events. Furthermore, a potential for lower cost of care without a compromise in clinical outcomes exists. These studies provide the framework and justification for performing PCI in an ASC. The Society for Cardiovascular Angiography and Interventions (SCAI) supported this coverage decision provided the quality and safety standards for PCI in an ASC were equivalent to the hospital setting. The current position paper is written to provide guidance for starting a PCI program in an ASC with an emphasis on maintaining quality standards. Regulatory requirements and appropriate standards for the facility, staff and physicians are delineated. The consensus document identified appropriate patients for consideration of PCI in an ASC. The key components of an ongoing quality assurance program are defined and the ethical issues relevant to PCI in an ASC are reviewed. This article is protected by copyright. All rights reserved.
PMID: 32406995
ISSN: 1522-726x
CID: 4438192

The IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact (IMPROVE) trial: Study design and rationale

Shlofmitz, Evan; Torguson, Rebecca; Mintz, Gary S; Zhang, Cheng; Sharp, Andrew; Hodgson, John McB; Shah, Binita; Kumar, Gautam; Singh, Jasvindar; Inderbitzen, Becky; Weintraub, William S; Garcia-Garcia, Hector M; Di Mario, Carlo; Waksman, Ron
Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) has been shown in clinical trials, registries, and meta-analyses to reduce recurrent major adverse cardiovascular events after PCI. However, IVUS utilization remains low. An increasing number of high-risk or complex coronary artery lesions are treated with PCI, and we hypothesize that the impact of IVUS in guiding treatment of these complex lesions will be of increased importance in reducing major adverse cardiovascular events while remaining cost-effective. The "IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact" trial (registered on NCT04221815) is a multicenter, international, clinical trial randomizing subjects to IVUS-guided versus angiography-guided PCI in a 1:1 ratio. Patients undergoing PCI involving a complex lesion are eligible for enrollment. Complex lesion is defined as involving at least 1 of the following characteristics: chronic total occlusion, in-stent restenosis, severe coronary artery calcification, long lesion (≥28 mm), or bifurcation lesion. The clinical investigation will be conducted at approximately 120 centers in North America and Europe, enrolling approximately 2,500 to 3,100 randomized subjects with an adaptive design. The primary clinical end point is the rate of target vessel failure at 12 months, defined as the composite of cardiac death, target vessel-related myocardial infarction, and ischemia-driven target vessel revascularization. The co-primary imaging end point is the final post-PCI minimum stent area assessed by IVUS. The primary objective of this study is to assess the impact of IVUS guidance on the PCI treatment of complex lesions.
PMID: 32866927
ISSN: 1097-6744
CID: 4593912

Considerations for Cardiac Catheterization Laboratory Procedures During the COVID-19 Pandemic Perspectives from the Society for Cardiovascular Angiography and Interventions Emerging Leader Mentorship (SCAI ELM) Members and Graduates

Szerlip, Molly; Anwaruddin, Saif; Aronow, Herbert D; Cohen, Mauricio G; Daniels, Matthew J; Dehghani, Payam; Drachman, Douglas E; Elmariah, Sammy; Feldman, Dmitriy N; Garcia, Santiago; Giri, Jay; Kaul, Prashant; Kapur, Navin; Kumbhani, Dharam J; Meraj, Perwaiz M; Morray, Brian; Nayak, Keshav R; Parikh, Sahil A; Sakhuja, Rahul; Schussler, Jeffrey M; Seto, Arnold; Shah, Binita; Swaminathan, Rajesh V; Zidar, David A; Naidu, Srihari S
PMID: 32212409
ISSN: 1522-726x
CID: 4358562

Gout and Progression of Aortic Stenosis

Adelsheimer, Andrew; Shah, Binita; Choy-Shan, Alana; Tenner, Craig T; Lorin, Jeffrey D; Smilowitz, Nathaniel R; Pike, V Courtney; Pillinger, Michael H; Donnino, Robert
BACKGROUND:Patients with aortic stenosis are nearly twice as likely to have a diagnosis of gout compared with individuals without aortic valve disease. METHODS:, and/or decrease in left ventricular ejection fraction due to aortic stenosis. RESULTS:/year [-0.16, -0.01], p=0.09); annualized change in peak velocity and mean gradient did not differ between groups. CONCLUSIONS:Progression to severe aortic stenosis was more frequent in patients with gout versus those without gout supporting the hypothesis that gout is a risk factor for aortic stenosis.
PMID: 32081657
ISSN: 1555-7162
CID: 4312662

Impact of COVID-19 pandemic on STEMI care: An expanded analysis from the United States

Garcia, Santiago; Stanberry, Larissa; Schmidt, Christian; Sharkey, Scott; Megaly, Michael; Albaghdadi, Mazen S; Meraj, Perwaiz M; Garberich, Ross; Jaffer, Farouc A; Stefanescu Schmidt, Ada C; Dixon, Simon R; Rade, Jeffrey J; Smith, Timothy; Tannenbaum, Mark; Chambers, Jenny; Aguirre, Frank; Huang, Paul P; Kumbhani, Dharam J; Koshy, Thomas; Feldman, Dmitriy N; Giri, Jay; Kaul, Prashant; Thompson, Craig; Khalili, Houman; Maini, Brij; Nayak, Keshav R; Cohen, Mauricio G; Bangalore, Sripal; Shah, Binita; Henry, Timothy D
OBJECTIVE:To evaluate the impact of COVID-19 pandemic migitation measures on of ST-elevation myocardial infarction (STEMI) care. BACKGROUND:We previously reported a 38% decline in cardiac catheterization activations during the early phase of the COVID-19 pandemic mitigation measures. This study extends our early observations using a larger sample of STEMI programs representative of different US regions with the inclusion of more contemporary data. METHODS:Data from 18 hospitals or healthcare systems in the US from January 2019 to April 2020 were collecting including number activations for STEMI, the number of activations leading to angiography and primary percutaneous coronary intervention (PPCI), and average door to balloon (D2B) times. Two periods, January 2019-February 2020 and March-April 2020, were defined to represent periods before (BC) and after (AC) initiation of pandemic mitigation measures, respectively. A generalized estimating equations approach was used to estimate the change in response variables at AC from BC. RESULTS:Compared to BC, the AC period was characterized by a marked reduction in the number of activations for STEMI (29%, 95% CI:18-38, p < .001), number of activations leading to angiography (34%, 95% CI: 12-50, p = .005) and number of activations leading to PPCI (20%, 95% CI: 11-27, p < .001). A decline in STEMI activations drove the reductions in angiography and PPCI volumes. Relative to BC, the D2B times in the AC period increased on average by 20%, 95%CI (-0.2 to 44, p = .05). CONCLUSIONS:The COVID-19 Pandemic has adversely affected many aspects of STEMI care, including timely access to the cardiac catheterization laboratory for PPCI.
PMID: 32767652
ISSN: 1522-726x
CID: 4555742

COVID-19 and the Heart and Vasculature: Novel Approaches to Reduce Virus-Induced Inflammation in Patients With Cardiovascular Disease

Kadosh, Bernard S; Garshick, Michael S; Gaztanaga, Juan; Moore, Kathryn J; Newman, Jonathan D; Pillinger, Michael; Ramasamy, Ravichandran; Reynolds, Harmony R; Shah, Binita; Hochman, Judith; Fishman, Glenn I; Katz, Stuart D
The coronavirus disease 2019 (COVID-19) pandemic presents an unprecedented challenge and opportunity for translational investigators to rapidly develop safe and effective therapeutic interventions. Greater risk of severe disease in COVID-19 patients with comorbid diabetes mellitus, obesity, and heart disease may be attributable to synergistic activation of vascular inflammation pathways associated with both COVID-19 and cardiometabolic disease. This mechanistic link provides a scientific framework for translational studies of drugs developed for treatment of cardiometabolic disease as novel therapeutic interventions to mitigate inflammation and improve outcomes in patients with COVID-19.
PMID: 32687400
ISSN: 1524-4636
CID: 4551152