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Trial Design Principles for Patients at High Bleeding Risk Undergoing PCI: JACC Scientific Expert Panel

Capodanno, Davide; Morice, Marie-Claude; Angiolillo, Dominick J; Bhatt, Deepak L; Byrne, Robert A; Colleran, Roisin; Cuisset, Thomas; Cutlip, Donald; Eerdmans, Pedro; Eikelboom, John; Farb, Andrew; Gibson, C Michael; Gregson, John; Haude, Michael; James, Stefan K; Kim, Hyo-Soo; Kimura, Takeshi; Konishi, Akihide; Leon, Martin B; Magee, P F Adrian; Mitsutake, Yoshiaki; Mylotte, Darren; Pocock, Stuart J; Rao, Sunil V; Spitzer, Ernest; Stockbridge, Norman; Valgimigli, Marco; Varenne, Olivier; Windhovel, Ute; Krucoff, Mitchel W; Urban, Philip; Mehran, Roxana
Investigating the balance of risk for thrombotic and bleeding events after percutaneous coronary intervention (PCI) is especially relevant for patients at high bleeding risk (HBR). The Academic Research Consortium for HBR recently proposed a consensus definition in an effort to standardize the patient population included in HBR trials. The aim of this consensus-based document, the second initiative from the Academic Research Consortium for HBR, is to propose recommendations to guide the design of clinical trials of devices and drugs in HBR patients undergoing PCI. The authors discuss the designs of trials in HBR patients undergoing PCI and various aspects of trial design specific to HBR patients, including target populations, intervention and control groups, primary and secondary outcomes, and timing of endpoint reporting.
PMID: 32943165
ISSN: 1558-3597
CID: 4593422

Management of Acute Myocardial Infarction During the COVID-19 Pandemic: A Position Statement From the Society for Cardiovascular Angiography and Interventions (SCAI), the American College of Cardiology (ACC), and the American College of Emergency Physicians (ACEP)

Mahmud, Ehtisham; Dauerman, Harold L; Welt, Frederick G P; Messenger, John C; Rao, Sunil V; Grines, Cindy; Mattu, Amal; Kirtane, Ajay J; Jauhar, Rajiv; Meraj, Perwaiz; Rokos, Ivan C; Rumsfeld, John S; Henry, Timothy D
The worldwide pandemic caused by the novel acute respiratory syndrome coronavirus 2 has resulted in a new and lethal disease termed coronavirus disease-2019 (COVID-19). Although there is an association between cardiovascular disease and COVID-19, the majority of patients who need cardiovascular care for the management of ischemic heart disease may not be infected with this novel coronavirus. The objective of this document is to provide recommendations for a systematic approach for the care of patients with an acute myocardial infarction (AMI) during the COVID-19 pandemic. There is a recognition of two major challenges in providing recommendations for AMI care in the COVID-19 era. Cardiovascular manifestations of COVID-19 are complex with patients presenting with AMI, myocarditis simulating an ST-elevation myocardial infarction (STEMI) presentation, stress cardiomyopathy, non-ischemic cardiomyopathy, coronary spasm, or nonspecific myocardial injury, and the prevalence of COVID-19 disease in the U.S. population remains unknown with risk of asymptomatic spread. This document addresses the care of these patients focusing on 1) the varied clinical presentations; 2) appropriate personal protection equipment (PPE) for health care workers; 3) role of the Emergency Department, Emergency Medical System and the Cardiac Catheterization Laboratory; and 4) Regional STEMI systems of care. During the COVID-19 pandemic, primary PCI remains the standard of care for STEMI patients at PCI capable hospitals when it can be provided in a timely fashion, with an expert team outfitted with PPE in a dedicated CCL room. A fibrinolysis-based strategy may be entertained at non-PCI capable referral hospitals or in specific situations where primary PCI cannot be executed or is not deemed the best option.
PMCID:7173829
PMID: 32330544
ISSN: 1558-3597
CID: 5222702

Multimodality Imaging in Evaluation of Cardiovascular Complications in Patients With COVID-19: JACC Scientific Expert Panel

Rudski, Lawrence; Januzzi, James L; Rigolin, Vera H; Bohula, Erin A; Blankstein, Ron; Patel, Amit R; Bucciarelli-Ducci, Chiara; Vorovich, Esther; Mukherjee, Monica; Rao, Sunil V; Beanlands, Rob; Villines, Todd C; Di Carli, Marcelo F
Standard evaluation and management of the patient with suspected or proven cardiovascular complications of coronavirus disease-2019 (COVID-19), the disease caused by severe acute respiratory syndrome related-coronavirus-2 (SARS-CoV-2), is challenging. Routine history, physical examination, laboratory testing, electrocardiography, and plain x-ray imaging may often suffice for such patients, but given overlap between COVID-19 and typical cardiovascular diagnoses such as heart failure and acute myocardial infarction, need frequently arises for advanced imaging techniques to assist in differential diagnosis and management. This document provides guidance in several common scenarios among patients with confirmed or suspected COVID-19 infection and possible cardiovascular involvement, including chest discomfort with electrocardiographic changes, acute hemodynamic instability, newly recognized left ventricular dysfunction, as well as imaging during the subacute/chronic phase of COVID-19. For each, the authors consider the role of biomarker testing to guide imaging decision-making, provide differential diagnostic considerations, and offer general suggestions regarding application of various advanced imaging techniques.
PMCID:7375789
PMID: 32710927
ISSN: 1558-3597
CID: 5222792

Navigation of a Dormant AV Fistula for PCI in a Patient With High-Risk NSTEMI [Case Report]

Friede, Kevin A; Wegermann, Zachary K; Rao, Sunil V
Arteriovenous (AV) fistulae for hemodialysis in patients with end-stage renal disease usually prevents ipsilateral transradial access (TRA) for coronary angiography. We present a case of coronary angiography and percutaneous coronary intervention via left TRA with navigation through a dormant AV fistula in a patient with limited vascular access. (Level of Difficulty: Intermediate.).
PMCID:8312011
PMID: 34317031
ISSN: 2666-0849
CID: 5223032

Splanchnic Nerve Block for Chronic Heart Failure

Fudim, Marat; Boortz-Marx, Richard L; Ganesh, Arun; DeVore, Adam D; Patel, Chetan B; Rogers, Joseph G; Coburn, Aubrie; Johnson, Inneke; Paul, Amanda; Coyne, Brian J; Rao, Sunil V; Gutierrez, J Antonio; Kiefer, Todd L; Kong, David F; Green, Cynthia L; Jones, W Schuyler; Felker, G Michael; Hernandez, Adrian F; Patel, Manesh R
OBJECTIVES:We hypothesized that splanchnic nerve blockade (SNB) would attenuate increased exercise-induced cardiac filling pressures in patients with chronic HF. BACKGROUND:Chronic heart failure (HF) is characterized by limited exercise capacity driven in part by an excessive elevation of cardiac filling pressures. METHODS:This is a prospective, open-label, single-arm interventional study in chronic HF patients. Eligible patients had a wedge pressure ≥15 mm Hg at rest or ≥25 mm Hg with exercise on baseline right heart catheterization. Patients underwent cardiopulmonary exercise testing with invasive hemodynamic assessment, followed by percutaneous SNB with ropivacaine. RESULTS:(9.1 ± 2.5 vs. 9.8 ± 2.7 ml/kg/min; p = 0.053). CONCLUSIONS:SNB reduced resting and exercise-induced pulmonary arterial and wedge pressure with favorable effects on cardiac output and exercise capacity. Continued efforts to investigate short- and long-term effects of SNB in chronic HF are warranted. Clinical Trials Registration (Abdominal Nerve Blockade in Chronic Heart Failure; NCT03453151).
PMID: 32535123
ISSN: 2213-1787
CID: 5222772

Response by Amin et al to Letters Regarding Article, "The Evolving Landscape of Impella Use in the United States Among Patients Undergoing Percutaneous Coronary Intervention With Mechanical Circulatory Support" [Comment]

Amin, Amit P; Rao, Sunil V; Bach, Richard G; Curtis, Jeptha P; Desai, Nihar; McNeely, Christian; Al-Badarin, Firas; House, John A; Kulkarni, Hemant; Masoudi, Frederick A; Spertus, John A
PMID: 32776840
ISSN: 1524-4539
CID: 5222822

Limitations of Observational Analyses of Multivessel PCI in Cardiogenic Shock [Comment]

Rao, Sunil V; Thiele, Holger
PMID: 32763079
ISSN: 1876-7605
CID: 5222812

Performance Metrics to Improve Quality in Contemporary Percutaneous Coronary Intervention Practice

Klein, Lloyd W; Anderson, H Vernon; Rao, Sunil V
PMID: 32374347
ISSN: 2380-6591
CID: 5222732

A systematic review of randomized trials comparing double versus triple antithrombotic therapy in patients with atrial fibrillation undergoing percutaneous coronary intervention

Sullivan, Alexander E; Nanna, Michael G; Rao, Sunil V; Cantrell, Sarah; Gibson, C Michael; Verheugt, Freek W A; Peterson, Eric D; Lopes, Renato D; Alexander, John H; Granger, Christopher B; Yee, Megan K; Kong, David F
BACKGROUND:Prior randomized controlled trials (RCT) evaluating the optimal antithrombotic therapies for patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) have not been powered to evaluate ischemic outcomes. We compared double therapy with oral anticoagulation (OAC) and a P2Y12 inhibitor to triple therapy with an OAC + dual antiplatelet therapy in patients with AF requiring PCI. METHODS:Using PRISMA guidelines, we searched for RCTs including patients with AF as an indication for OAC and undergoing PCI or medical management of acute coronary syndrome. The results were pooled using fixed-effects and random-effects models to estimate the overall effect of double therapy versus triple therapy on ischemic and bleeding outcomes. RESULTS:= 64%), as were intracranial hemorrhages (19/5470 vs. 30/4710; fixed effect model OR 0.54, 95% CI 0.31-0.96). CONCLUSIONS:Double therapy in patients with AF requiring OAC following PCI or Acute coronary syndrome has a significantly better safety profile than triple therapy but may be associated with a modest increased risk of stent thrombosis.
PMCID:7211549
PMID: 31713326
ISSN: 1522-726x
CID: 5222512

Cardiac Imaging in the Post-ISCHEMIA Trial Era: A Multisociety Viewpoint

Shaw, Leslee; Kwong, Raymond Y; Nagel, Eike; Salerno, Michael; Jaffer, Farouc; Blankstein, Ron; Dilsizian, Vasken; Flachskampf, Frank; Grayburn, Paul; Leipsic, Jonathan; Marwick, Tom; Nieman, Koen; Raman, Subha; Sengupta, Partho; Zoghbi, William; Pellikka, Patricia A; Swaminathan, Madhav; Dorbala, Sharmila; Thompson, Randall; Al-Mallah, Mouaz; Calnon, Dennis; Polk, Donna; Soman, Prem; Beanlands, Rob; Garrett, Kirk N; Henry, Timothy D; Rao, Sunil V; Duffy, Peter L; Cox, David; Grines, Cindy; Mahmud, Ehtisham; Bucciarelli-Ducci, Chiara; Plein, Sven; Greenwood, John P; Berry, Colin; Carr, James; Arai, Andrew E; Murthy, Venkatesh L; Ruddy, Terrence D; Chandrashekhar, Y
PMID: 32762886
ISSN: 1876-7591
CID: 5222802