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Real-World Data on the Intravascular Microaxial Left Ventricular Flow Pump (Impella) in High-Risk Patients

Rao, Sunil V
Mechanical circulatory support (MCS) devices maintain or improve hemodynamic profiles in patients at risk for hemodynamic deterioration during percutaneous coronary intervention (PCI) or those in cardiogenic shock. Clinical trials of MCS have been difficult to complete due to challenges with equipoise; however, there are several "real-world" comparative effectiveness analyses of outcomes of patients undergoing high-risk PCI or cardiogenic shock with different MCS. This review summarizes the real-world data on Impella and intra-aortic balloon pump, 2 of the most commonly used MCS, and provides insight into the limitations of such data and challenges to completing clinical trials.
PMCID:8176068
PMID: 34085421
ISSN: 1738-5520
CID: 5222992

Interventional cardiologists' perceptions of percutaneous coronary intervention quality measurement and feedback

Prabhu, Krishna M; Don, Creighton; Sayre, George G; Kearney, Kathleen E; Hira, Ravi S; Waldo, Stephen W; Rao, Sunil V; Au, David H; Doll, Jacob A
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.
PMID: 33567319
ISSN: 1097-6744
CID: 5222912

Percutaneous coronary intervention in patients with stable coronary artery disease and left ventricular systolic dysfunction: insights from the VA CART program

Brophy, Todd J; Warsavage, Theodore J; Hebbe, Annika L; Plomondon, Mary E; Waldo, Stephen W; Rao, Sunil V; DeVore, Adam D; Gutierrez, J Antonio; Swaminathan, Rajesh V
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.
PMID: 33567318
ISSN: 1097-6744
CID: 5222902

Characteristics and Outcomes of Patients With History of CABG Undergoing Cardiac Catheterization Via the Radial Versus Femoral Approach

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; Rao, Sunil V
OBJECTIVES: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. BACKGROUND:There are limited data comparing outcomes of patients with prior CABG undergoing transradial or transfemoral diagnostic catheterization and/or PCI. METHODS: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. RESULTS: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. CONCLUSIONS: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.
PMID: 33812824
ISSN: 1876-7605
CID: 5222952

The association between coronary graft patency and clinical status in patients with coronary artery disease

Gaudino, Mario; Di Franco, Antonino; Bhatt, Deepak L; Alexander, John H; Abbate, Antonio; Azzalini, Lorenzo; Sandner, Sigrid; Sharma, Garima; Rao, Sunil V; Crea, Filippo; Fremes, Stephen E; Bangalore, Sripal
The concept of a direct association between coronary graft patency and clinical status is generally accepted. However, the relationship is more complex and variable than usually thought. Key issues are the lack of a common definition of graft occlusion and of a standardized imaging protocol for patients undergoing coronary bypass surgery. Factors like the type of graft, the timing of the occlusion, and the amount of myocardium at risk, as well as baseline patients' characteristics, modulate the patency-to-clinical status association. Available evidence suggests that graft occlusion is more often associated with non-fatal events rather than death. Also, graft failure due to competitive flow is generally a benign event, while graft occlusion in a graft-dependent circulation is associated with clinical symptoms. In this systematic review, we summarize the evidence on the association between graft status and clinical outcomes.
PMID: 33709098
ISSN: 1522-9645
CID: 4809562

Pumping up best practices in radial artery access: prolonged occlusion flow-mediated dilation improves radial artery access success

Rao, Sunil V; Wegermann, Zachary K
PMID: 33749599
ISSN: 1969-6213
CID: 5222942

Invasive Management of Acute Myocardial Infarction Complicated by Cardiogenic Shock: A Scientific Statement From the American Heart Association

Henry, Timothy D; Tomey, Matthew I; Tamis-Holland, Jacqueline E; Thiele, Holger; Rao, Sunil V; Menon, Venu; Klein, Deborah G; Naka, Yoshifumi; Piña, Ileana L; Kapur, Navin K; Dangas, George D
Cardiogenic shock (CS) remains the most common cause of mortality in patients with acute myocardial infarction. The SHOCK trial (Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock) demonstrated a survival benefit with early revascularization in patients with CS complicating acute myocardial infarction (AMICS) 20 years ago. After an initial improvement in mortality related to revascularization, mortality rates have plateaued. A recent Society of Coronary Angiography and Interventions classification scheme was developed to address the wide range of CS presentations. In addition, a recent scientific statement from the American Heart Association recommended the development of CS centers using standardized protocols for diagnosis and management of CS, including mechanical circulatory support devices (MCS). A number of CS programs have implemented various protocols for treating patients with AMICS, including the use of MCS, and have published promising results using such protocols. Despite this, practice patterns in the cardiac catheterization laboratory vary across health systems, and there are inconsistencies in the use or timing of MCS for AMICS. Furthermore, mortality benefit from MCS devices in AMICS has yet to be established in randomized clinical trials. In this article, we outline the best practices for the contemporary interventional management of AMICS, including coronary revascularization, the use of MCS, and special considerations such as the treatment of patients with AMICS with cardiac arrest.
PMID: 33657830
ISSN: 1524-4539
CID: 4801572

Sounding the alarm: Academic interventional cardiology at a crossroads [Editorial]

Klein, Lloyd W; Rao, Sunil V
PMID: 33249094
ISSN: 1097-6744
CID: 5222872

Ventricular Fibrillation Due to Aortocoronary Vein Graft Spasm During Angiography: Case Report and Literature Review [Case Report]

Arps, Kelly; Chakravartti, Jaidip; Hess, Connie N; Rao, Sunil V
A 69-year-old man underwent coronary angiography 7 years after coronary artery bypass. Saphenous vein graft spasm was observed during contrast injection, resulting in ventricular fibrillation. Angiography 6 years later showed graft patency. Vein graft spasm after coronary artery bypass grafting is rarely described. Further investigation is needed regarding incidence, mechanism, and clinical outcomes. (Level of Difficulty: Beginner.).
PMID: 34317543
ISSN: 2666-0849
CID: 5223042

Algorithms for challenging scenarios encountered in transradial intervention

Sawant, Abhishek C; Rizik, David G; Rao, Sunil V; Pershad, Ashish
Transradial intervention (TRI) was first introduced by Lucien Campeau in 1989 and since then has created a lasting impact in the field of interventional cardiology. Several studies have demonstrated that TRI is associated with fewer vascular site complications, offer earlier ambulation and greater post-procedural comfort. Patients presenting with ST Segment Elevation Myocardial Infarction (STEMI) have experienced survival benefit and higher quality-of-life metrics as well with TRI. While both the updated scientific statement by the American Heart Association and the 2017 European Society of Cardiology guidelines recommend a "radial first" approach there appears to be a lag in physicians adapting TRI as the preferred vascular access. We present a review focusing on identification and management of TRA related challenges and complications using a systematic algorithmic approach.
PMCID:8065373
PMID: 33865510
ISSN: 2213-3763
CID: 5222972