626 results on '"Timothy D Henry"'
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2. Impaired therapeutic efficacy of bone marrow cells from post-myocardial infarction patients in the TIME and LateTIME clinical trials.
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Xiaoyin Wang, Lourdes I Chacon, Ronak Derakhshandeh, Hilda J Rodriguez, Daniel D Han, Dmitry S Kostyushev, Timothy D Henry, Jay H Traverse, Lem Moyé, Robert D Simari, Doris A Taylor, and Matthew L Springer
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Medicine ,Science - Abstract
Implantation of bone marrow-derived cells (BMCs) into mouse hearts post-myocardial infarction (MI) limits cardiac functional decline. However, clinical trials of post-MI BMC therapy have yielded conflicting results. While most laboratory experiments use healthy BMC donor mice, clinical trials use post-MI autologous BMCs. Post-MI mouse BMCs are therapeutically impaired, due to inflammatory changes in BMC composition. Thus, therapeutic efficacy of the BMCs progressively worsens after MI but recovers as donor inflammatory response resolves. The availability of post-MI patient BM mononuclear cells (MNCs) from the TIME and LateTIME clinical trials enabled us to test if human post-MI MNCs undergo a similar period of impaired efficacy. We hypothesized that MNCs from TIME trial patients would be less therapeutic than healthy human donor MNCs when implanted into post-MI mouse hearts, and that therapeutic properties would be restored in MNCs from LateTIME trial patients. Post-MI SCID mice received MNCs from healthy donors, TIME patients, or LateTIME patients. Cardiac function improved considerably in the healthy donor group, but neither the TIME nor LateTIME group showed therapeutic effect. Conclusion: post-MI human MNCs lack therapeutic benefits possessed by healthy MNCs, which may partially explain why BMC clinical trials have been less successful than mouse studies.
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- 2020
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3. SCAI Expert Consensus Statement on the Management of Patients With STEMI Referred for Primary PCI
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Jacqueline E. Tamis-Holland, MD, FSCAI (Chair), J. Dawn Abbott, MD, FSCAI, Karim Al-Azizi, MD, FSCAI, Nitin Barman, MD, Anna E. Bortnick, MD, PhD, MSc, FSCAI, Mauricio G. Cohen, MD, FSCAI, Payam Dehghani, MD, FSCAI, Timothy D. Henry, MD, MSCAI, Faisal Latif, MD, FSCAI, Mohammad Madjid, MD, FSCAI, Celina M. Yong, MD, MBA, MSc, FSCAI, and Yader Sandoval, MD, FSCAI (Co-Chair)
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intravascular imaging ,mechanical circulatory support ,microvascular obstruction ,no reflow ,PCI ,STEMI ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
ST-elevation myocardial infarction (STEMI) remains a leading cause of morbidity and mortality in the United States. Timely reperfusion with primary percutaneous coronary intervention is associated with improved outcomes. The Society for Cardiovascular Angiography & Interventions puts forth this expert consensus document regarding best practices for cardiac catheterization laboratory team readiness, arterial access with an algorithm to help determine proper arterial access in STEMI, and diagnostic angiography. This consensus statement highlights the strengths and limitations of various diagnostic and therapeutic interventions to access and treat a patient with STEMI in the catheterization laboratory, reviews different options to manage large thrombus burden during STEMI, and reviews the management of STEMI across the spectrum of various anatomical and clinical circumstances.
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- 2024
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4. The Revolution of STEMI Care: A Story of Resilience, Persistence, and Success
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Paul Bamford, MBChB, Timothy D. Henry, MD, William W. O’Neill, MD, and Cindy L. Grines, MD
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interventional cardiology ,percutaneous transluminal coronary angioplasty ,primary percutaneous coronary intervention ,ST-elevation myocardial infarction ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Published
- 2024
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5. Age and shock severity predict mortality in cardiac intensive care unit patients with and without heart failure
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Mitchell Padkins, Thomas Breen, Nandan Anavekar, Sean vanDiepen, Timothy D. Henry, David A. Baran, Gregory W. Barsness, Kianoush Kashani, David R. Holmes Jr, and Jacob C. Jentzer
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Age ,Shock ,Mortality ,Cardiac intensive care unit ,Critical care ,Cardiogenic shock ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Abstract Aims Age is an important risk factor for mortality among patients with cardiogenic shock and heart failure (HF). We sought to assess the extent to which age modified the performance of the Society for Cardiovascular Angiography and Interventions (SCAI) shock stage for in‐hospital and 1 year mortality in cardiac intensive care unit (CICU) patients with and without HF. Methods and results We retrospectively reviewed unique admissions to the Mayo Clinic CICU during 2007–2015 and stratified patients by age and SCAI shock stage. The association between age and in‐hospital mortality was analysed using multivariable logistic regression, and 1 year mortality was analysed using Cox proportional hazards analysis, both in the entire cohort and among patients with an admission diagnosis of HF or acute coronary syndrome (ACS). The final study population included 10 004 unique patients with a mean age of 67 ± 15 years, including 46.1% with HF and 43.1% with ACS. Older patients more frequently had HF and had more extensive co‐morbidities, higher illness severity, more organ failure, and differential use of critical care therapies. The percentage of patients with SCAI shock stages A, B, C, D, and E were 46%, 30%, 16%, 7%, and 1%, respectively. Patients with HF were older, had greater severity of illness and higher SCAI shock stage, and had higher rates of death at all time points. In‐hospital mortality occurred in 908 (9%) patients, including 549 (12%) patients with HF (61% of all hospital deaths). Age was independently associated with hospital mortality (adjusted odds ratio per 10 years 1.3, 95% confidence interval 1.2–1.4, P
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- 2020
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6. CD34+ cell therapy significantly reduces adverse cardiac events, health care expenditures, and mortality in patients with refractory angina
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Grace L. Johnson, Timothy D. Henry, Thomas J. Povsic, Douglas W. Losordo, Ross F. Garberich, Larissa I. Stanberry, Craig E. Strauss, and Jay H. Traverse
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CD34+ stem cells ,cost analysis ,major adverse cardiac events ,refractory angina ,Medicine (General) ,R5-920 ,Cytology ,QH573-671 - Abstract
Abstract Patients with refractory angina who are suboptimal candidates for further revascularization have improved exercise time, decreased angina frequency, and reduced major adverse cardiac events with intramyocardial delivery of CD34+ cells. However, the effect of CD34+ cell therapy on health care expenditures before and after treatment is unknown. We determined the effect of CD34+ cell therapy on cardiac‐related hospital visits and costs during the 12 months following stem cell injection compared with the 12 months prior to injection. Cardiac‐related hospital admissions and procedures were retrospectively tabulated for patients enrolled at one site in one of three double‐blinded, placebo‐controlled CD34+ trials in the 12 months before and after intramyocardial injections of CD34+ cells vs placebo. Fifty‐six patients were randomized to CD34+ cell therapy (n = 37) vs placebo (n = 19). Patients randomized to cell therapy experienced 1.57 ± 1.39 cardiac‐related hospital visits 12 months before injection, compared with 0.78 ± 1.90 hospital visits 12 months after injection, which was associated with a 62% cost reduction translating to an average savings of $5500 per cell therapy patient. Patients in the placebo group also demonstrated a reduction in cardiac‐related hospital events and costs, although to a lesser degree than the CD34+ group. Through 1 January 2019, 24% of CD34+ subjects died at an average of 6.5 ± 2.4 years after enrollment, whereas 47% of placebo patients died at an average of 3.7 ± 1.9 years after enrollment. In conclusion, CD34+ cell therapy for subjects with refractory angina is associated with improved mortality and a reduction in hospital visits and expenditures for cardiac procedures in the year following treatment.
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- 2020
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7. STEMI care 2021: Addressing the knowledge gaps
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Mehmet Yildiz, Spencer R. Wade, and Timothy D. Henry
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ST-segment elevation myocardial infarction ,Regional systems ,Cardiogenic shock ,Out-of-hospital cardiac arrest ,Covid-19 ,Cangrelor ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Tremendous progress has been made in the treatment of ST-segment elevation myocardial infarction (STEMI), the most severe and time-sensitive acute coronary syndrome. Primary percutaneous coronary intervention (PCI) is the preferred method of reperfusion, which has stimulated the development of regional STEMI systems of care with standardized protocols designed to optimize care. However, challenges remain for patients with cardiogenic shock, out-of-hospital cardiac arrest, an expected delay to reperfusion (>120 min), in-hospital STEMI, and more recently, those with Covid-19 infection. Ultimately, the goal is to provide timely reperfusion with primary PCI coupled with the optimal antiplatelet and anticoagulant therapies. We review the challenges and provide insights into the remaining knowledge gaps for contemporary STEMI care.
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- 2021
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8. 'Back to the Future' for STEMI?
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Robert F. Riley, MD, MS, Dean J. Kereiakes, MD, Ehtisham Mahmud, MD, Timothy D. Smith, Cindy Grines, MD, and Timothy D. Henry, MD
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acute coronary syndrome ,complication ,public health ,STEMI ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Published
- 2020
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9. Interaction of COVID-19 With Common Cardiovascular Disorders
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Peter K. Boulos, Scott V. Freeman, Timothy D. Henry, Ehtisham Mahmud, and John C. Messenger
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Physiology ,Cardiology and Cardiovascular Medicine - Abstract
The onset and widespread dissemination of the severe acute respiratory syndrome coronavirus-2 in late 2019 impacted the world in a way not seen since the 1918 H1N1 pandemic, colloquially known as the Spanish Flu. Much like the Spanish Flu, which was observed to disproportionately impact young adults, it became clear in the early days of the coronavirus disease 2019 (COVID-19) pandemic that certain groups appeared to be at higher risk for severe illness once infected. One such group that immediately came to the forefront and garnered international attention was patients with preexisting cardiovascular disease. Here, we examine the available literature describing the interaction of COVID-19 with a myriad of cardiovascular conditions and diseases, paying particular attention to patients diagnosed with arrythmias, heart failure, and coronary artery disease. We further discuss the association of acute COVID-19 with de novo cardiovascular disease, including myocardial infarction due to coronary thrombosis, myocarditis, and new onset arrhythmias. We will evaluate various biochemical theories to explain these findings, including possible mechanisms of direct myocardial injury caused by the severe acute respiratory syndrome coronavirus-2 virus at the cellular level. Finally, we will discuss the strategies employed by numerous groups and governing bodies within the cardiovascular disease community to address the unprecedented challenges posed to the care of our most vulnerable patients, including heart transplant recipients, end-stage heart failure patients, and patients suffering from acute coronary syndromes, during the early days and height of the COVID-19 pandemic.
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- 2023
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10. Value of Registries in ST‐Segment–Elevation Myocardial Infarction Care in Both the Pre–Coronavirus Disease 2019 and the Coronavirus Disease 2019 Eras
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Ralph G. Brindis, Eric R. Bates, and Timothy D. Henry
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Editorials ,acute coronary syndrome ,coronary artery disease ,coronavirus disease 2019 ,percutaneous coronary intervention ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Published
- 2021
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11. Randomized Trial of Targeted Transendocardial Mesenchymal Precursor Cell Therapy in Patients With Heart Failure
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Emerson C. Perin, Kenneth M. Borow, Timothy D. Henry, Farrell O. Mendelsohn, Leslie W. Miller, Elizabeth Swiggum, Eric D. Adler, David H. Chang, R. David Fish, Alain Bouchard, Margaret Jenkins, Alex Yaroshinsky, Jack Hayes, Olga Rutman, Christopher W. James, Eric Rose, Silviu Itescu, and Barry Greenberg
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Cardiology and Cardiovascular Medicine - Published
- 2023
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12. Extracorporeal Membrane Oxygenation for Cardiogenic Shock: When to Open the Parachute?
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Timothy D. Henry, Demetri Yannopoulos, and Sean van Diepen
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Physiology (medical) ,Cardiology and Cardiovascular Medicine - Published
- 2023
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13. Confronting system barriers for ST- elevation MI in low and middle income countries with a focus on India
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Sameer Mehta, Christopher Granger, Cindy Lee Grines, Alice Jacobs, Timothy D. Henry, Ivan Rokos, Alexandra Lansky, Andreas Baumbach, Roberto Botelho, Alexandra Ferre, Isaac Yepes, Roopa Salwan, Jamshed Dalal, Jitendra Makkar, Neeraj Bhalla, Sundeep Mishra, Vinod Vijan, and Shirish Hiremath
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STEMI ,ACC/AHA guidelines ,PPCI ,Telemedicine ,Surgery ,RD1-811 ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Our previous research found seven specific factors that cause system delays in ST-elevation Myocardial infarction management in developing countries. These delays, in conjunction with a lack of organized STEMI systems of care, result in inefficient processes to treat AMI in developing countries. In our present opinion paper, we have specifically explored the three most pertinent causes that afflict the seven specific factors responsible for system delays. In doing so, we incorporated a unique strategy of global STEMI expertise. With this methodology, the recommendations were provided by expert Indian cardiologist and final guidelines were drafted after comprehensive discussions by the entire group of submitting authors. We expect these recommendations to be utilitarian in improving STEMI care in developing countries.
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- 2018
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14. Circulating Biomarkers to Identify Responders in Cardiac Cell therapy
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Jesse V. Jokerst, Nicholas Cauwenberghs, Tatiana Kuznetsova, Francois Haddad, Timothy Sweeney, Jiayi Hou, Yael Rosenberg-Hasson, Eric Zhao, Robert Schutt, Roberto Bolli, Jay H. Traverse, Carl J. Pepine, Timothy D. Henry, Ivonne H. Schulman, Lem Moyé, Doris A. Taylor, and Phillip C. Yang
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Medicine ,Science - Abstract
Abstract Bone marrow mononuclear cell (BM-MNC) therapy in ST-elevation acute myocardial infarction (STEMI) has no biological inclusion criteria. Here, we analyzed 63 biomarkers and cytokines in baseline plasma samples from 77 STEMI patients treated with BM-MNCs in the TIME and Late-TIME trials as well as 61 STEMI patients treated with placebo. Response to cell therapy was defined by changes in left ventricular ejection fraction, systolic/diastolic volumes, and wall motion indexes. We investigated the clinical value of circulating proteins in outcome prediction using significance testing, partial least squares discriminant analysis, and receiver operating characteristic (ROC) analysis. Responders had higher biomarker levels (76–94% elevated) than non-responders. Several biomarkers had values that differed significantly (P 0.70 including interleukin 15. These biomarkers were not involved in the placebo-treated subjects suggesting that they may have predictive power. We conclude that plasma profiling after STEMI may help identify patients with a greater likelihood of response to cell-based treatment. Prospective trials are needed to assess the predictive value of the circulating biomarkers.
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- 2017
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15. Prehospital Activation of Hospital Resources (PreAct) ST‐Segment–Elevation Myocardial Infarction (STEMI): A Standardized Approach to Prehospital Activation and Direct to the Catheterization Laboratory for STEMI Recommendations From the American Heart Association's Mission: Lifeline Program
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Michael C. Kontos, Michael R. Gunderson, Jessica K. Zegre‐Hemsey, David C. Lange, William J. French, Timothy D. Henry, James J. McCarthy, Claire Corbett, Alice K. Jacobs, James G. Jollis, Steven V. Manoukian, Robert E. Suter, David T. Travis, and J. Lee Garvey
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emergency department ,emergency medical services ,myocardial infarction ,ST‐segment–elevation myocardial infarction ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Published
- 2020
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16. Association of Cognitive Impairment With Treatment and Outcomes in Older Myocardial Infarction Patients: A Report From the NCDR Chest Pain–MI Registry
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Akshay Bagai, Anita Y. Chen, Jacob A. Udell, John A. Dodson, David D. McManus, Mathew S. Maurer, Jonathan R. Enriquez, Judith Hochman, Abhinav Goyal, Timothy D. Henry, Martha Gulati, Kirk N. Garratt, Matthew T. Roe, and Karen P. Alexander
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cognitive impairment ,myocardial infarction ,percutaneous coronary intervention ,health services research ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Background Little is known regarding use of cardiac therapies and clinical outcomes among older myocardial infarction (MI) patients with cognitive impairment. Methods and Results Patients ≥65 years old with MI in the NCDR (National Cardiovascular Data Registry) Chest Pain–MI Registry between January 2015 and December 2016 were categorized by presence and degree of chart‐documented cognitive impairment. We evaluated whether cognitive impairment was associated with all‐cause in‐hospital mortality after adjusting for known prognosticators. Among 43 812 ST‐segment–elevation myocardial infarction (STEMI) patients, 3.9% had mild and 2.0% had moderate/severe cognitive impairment; among 90 904 non–ST‐segment–elevation myocardial infarction (NSTEMI patients, 5.7% had mild and 2.6% had moderate/severe cognitive impairment. A statistically significant but numerically small difference in the use of primary percutaneous coronary intervention was observed between patients with STEMI with and without cognitive impairment (none, 92.1% versus mild, 92.8% versus moderate/severe, 90.4%; P=0.03); use of fibrinolysis was lower among patients with cognitive impairment (none, 40.9% versus mild, 27.4% versus moderate/severe, 24.2%; P
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- 2019
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17. Contemporary Management of Refractory Angina
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Rebekah, Lantz, Odayme, Quesada, Georgia, Mattingly, and Timothy D, Henry
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Risk Factors ,Myocardial Ischemia ,Quality of Life ,Humans ,Coronary Artery Disease ,Cardiology and Cardiovascular Medicine ,Article ,Angina Pectoris - Abstract
Refractory angina is defined as chest pain caused by coronary ischemia in patients on maximal medical therapy and not amenable to revascularization despite advanced coronary artery disease. The long term prognosis has improved with optimal medical therapy including risk factor modification. Still, patients are left with major impairment in quality of life and have high resource utilization with limited treatment options. We review the novel invasive and non-invasive therapies under investigation for refractory angina.
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- 2022
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18. Safety of Provocative Testing With Intracoronary Acetylcholine and Implications for Standard Protocols
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Tatsunori Takahashi, Bruce A. Samuels, Weijia Li, Manish A. Parikh, Janet Wei, Jeffery W. Moses, William F. Fearon, Timothy D. Henry, Jennifer A. Tremmel, and Yuhei Kobayashi
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Spasm ,Meta-Analysis as Topic ,Ventricular Fibrillation ,Coronary Vasospasm ,Humans ,Coronary Angiography ,Cardiology and Cardiovascular Medicine ,Coronary Vessels ,Acetylcholine - Abstract
Heterogeneity in diagnostic criteria and provocation protocols has posed challenges in understanding the safety of coronary provocation testing with intracoronary acetylcholine (ACh) for the contemporary diagnosis of epicardial and microvascular spasm.We examined the safety of testing and subgroup differences in procedural risks based on ethnicity, diagnostic criteria, and provocation protocols.PubMed and Embase were searched in November 2021 to identify original articles reporting procedural complications associated with intracoronary ACh administration. The primary outcome was the pooled estimate of the incidence of major complications including death, myocardial infarction, ventricular tachycardia/fibrillation, and shock.A total of 16 studies with 12,585 patients were included in the meta-analysis. The overall pooled estimate of the incidence of major complications was 0.5% (95% CI: 0.0%-1.3%) without any reports of death. Exploratory subgroup analyses revealed that the pooled incidence of major complications was significantly higher in the studies that followed the contemporary diagnosis criteria for epicardial spasm defined as ≥90% diameter reduction (1.0%; 95% CI: 0.3%-2.0%) but significantly lower in Western populations (0.0%; 95% CI: 0.0%-0.45%). The rate of positive epicardial spasm and the incidence of major complications were similar between provocation protocols using the maximum ACh doses of 100 μg and 200 μg.Intracoronary ACh administration for the contemporary diagnosis of epicardial and microvascular spasm is a safe procedure. Moreover, excellent safety records are observed in Western populations primarily presenting with myocardial ischemia and/or infarction with nonobstructive coronary arteries. This study will help standardize ACh testing to improve clinical diagnosis and ensure procedural safety.
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- 2022
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19. Trends in Clinical Presentation, Management, and Outcomes of STEMI in Patients With COVID-19
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Santiago Garcia, Payam Dehghani, Larissa Stanberry, Cindy Grines, Rajan A.G. Patel, Keshav R. Nayak, Avneet Singh, Wah Wah Htun, Ameer Kabour, Nima Ghasemzadeh, Cristina Sanina, Joseph Aragon, M. Chadi Alraies, Catherine Benziger, Brynn Okeson, Ross Garberich, Frederick G. Welt, Laura Davidson, Abdul Moiz Hafiz, Deepak Acharya, Jay Stone, Aditya Mehra, Shy Amlani, Ehtisham Mahmud, Jay Giri, Mehmet Yildiz, and Timothy D. Henry
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Percutaneous Coronary Intervention ,COVID-19 ,Humans ,ST Elevation Myocardial Infarction ,Hospital Mortality ,Prospective Studies ,Cardiology and Cardiovascular Medicine - Abstract
We previously reported high in-hospital mortality for ST-segment elevation myocardial infarction (STEMI) patients with COVID-19 treated in the early phase of the pandemic.The purpose of this study was to describe trends of COVID-19 patients with STEMI during the course of the pandemic.The NACMI (North American COVID-19 STEMI) registry is a prospective, investigator-initiated, multicenter, observational registry of hospitalized STEMI patients with confirmed or suspected COVID-19 infection in North America. We compared trends in clinical characteristics, management, and outcomes of patients treated in the first year of the pandemic (January 2020 to December 2020) vs those treated in the second year (January 2021 to December 2021).A total of 586 COVID-19-positive patients with STEMI were included in the present analysis; 227 treated in Y2020 and 359 treated in Y2021. Patients' characteristics changed over time. Relative to Y2020, the proportion of Caucasian patients was higher (58% vs 39%; P 0.001), patients presented more frequently with typical ischemic symptoms (59% vs 51%; P = 0.04), and patients were less likely to have shock pre-PCI (13% vs 18%; P = 0.07) or pulmonary manifestations (33% vs. 47%; P = 0.001) in Y2021. In-hospital mortality decreased from 33% (Y2020) to 23% (Y2021) (P = 0.008). In Y2021, none of the 22 vaccinated patients expired in hospital, whereas in-hospital death was recorded in 37 (22%) unvaccinated patients (P = 0.009).Significant changes have occurred in the clinical characteristics and outcomes of STEMI patients with COVID-19 infection during the course of the pandemic.
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- 2022
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20. Implications of the 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Chest Pain Guideline for Cardiovascular Imaging
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Ron Blankstein, Leslee J. Shaw, Martha Gulati, Michael K. Atalay, Jeroen Bax, Dennis A. Calnon, Christopher K. Dyke, Maros Ferencik, Jonathan F. Heitner, Timothy D. Henry, Judy Hung, Juhani Knuuti, Jonathan R. Lindner, Lawrence M. Phillips, Subha V. Raman, Sunil V. Rao, Frank J. Rybicki, Antti Saraste, Raymond F. Stainback, Randall C. Thompson, Eric Williamson, Koen Nieman, Jennifer A. Tremmel, Pamela K. Woodard, Marcelo F. Di Carli, and Y.S. Chandrashekhar
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Radiology, Nuclear Medicine and imaging ,Cardiology and Cardiovascular Medicine - Published
- 2022
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21. QFR Facilitated Functional Lesion Assessment to Guide Revascularization
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Timothy D. Henry and Dean J. Kereiakes
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Cardiology and Cardiovascular Medicine - Published
- 2022
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22. Time Course of Microvascular Stunning in ST-Segment–Elevation Myocardial Infarction
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Timothy D. Henry, Odayme Quesada, and Robert F. Wilson
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Cardiology and Cardiovascular Medicine - Published
- 2022
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23. Effects of a Community Population Health Initiative on Blood Pressure Control in Latinos
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James R. Langabeer, Timothy D. Henry, Carlos Perez Aldana, Larissa DeLuna, Nora Silva, and Tiffany Champagne‐Langabeer
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blood pressure measurement/monitoring ,ethnicity ,hypertension ,population ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Background Hypertension remains one of the most important, modifiable cardiovascular risk factors. Yet, the largest minority ethnic group (Hispanics/Latinos) often have different health outcomes and behavior, making hypertension management more difficult. We explored the effects of an American Heart Association–sponsored population health intervention aimed at modifying behavior of Latinos living in Texas. Methods and Results We enrolled 8071 patients, and 5714 (65.7%) completed the 90‐day program (58.5 years ±11.7; 59% female) from July 2016 to June 2018. Navigators identified patients with risk factors; initial and final blood pressure (BP) readings were performed in the physician's office; and interim home measurements were recorded telephonically. The intervention incorporated home BP monitoring, fitness and nutritional counseling, and regular follow‐up. Primary outcomes were change in systolic BP and health‐related quality of life. Using a univariate paired‐samples pre–post design, we found an average 5.5% (7.6‐mm Hg) improvement in systolic BP (139.1 versus 131.5, t=10.32, P
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- 2018
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24. Characteristics and Long-term Mortality in Patients with ST-Segment Elevation Myocardial Infarction with Non-Obstructive Coronary Arteries (STE-MINOCA): A High Risk Cohort
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Odayme Quesada, Mehmet Yildiz, Timothy D. Henry, Brynn K. Okeson, Jenny Chambers, Ananya Shah, Larissa Stanberry, Lucas Volpenhein, Dalia Aziz, Rebekah Lantz, Cassady Palmer, Justin Ugwu, Muhammad J. Ahsan, Ross F. Garberich, Heather S. Rohm, Frank V. Aguirre, Santiago Garcia, and Scott W. Sharkey
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Article - Abstract
BackgroundThe prognosis of ST-segment elevation myocardial infarction with non-obstructive coronaries (STE-MINOCA) is largely unknown.MethodsThe objective of this study is to evaluate the prevalence, characteristics, and 5-year mortality of patients with STE-MINOCA compared to STEMI with coronary artery obstruction (STEMI-Obstruction) using a multicenter cohort of consecutive STEMI patients at 3 regional Midwest STEMI programs from 2003 to 2020. STE-MINOCA was defined based on (1) coronary stenosis < 60% by visual estimation, (2) ischemia with elevated troponin, and (3) no alternative diagnosis. STE-MINOCA was further classified based on American Heart Association (AHA) definition as AHA STE-MINOCA and AHA STE-MINOCA Mimicker.Results8,566 STEMI patients, including 420 (4.9%) STE-MINOCA (26.9% AHA STE-MINOCA and 73.1% AHA STE-MINOCA Mimicker) were followed for a median of 7.1 years. Compared to STEMI-Obstruction, STE-MINOCA were younger, more often female, had fewer cardiovascular risk factors, and were less likely to be discharged on cardiac medications. At five years, mortality was higher in STE-MINOCA compared with STEMI-Obstruction (18% vs. 15%, p=0.033). In propensity score-matched analysis, STE-MINOCA had a 1.4-fold (95% CI: 1.04-1.89, p=0.028) higher risk of 5-year all-cause mortality compared with STEMI-Obstruction. Furthermore, 5-year mortality risk was significantly higher in AHA STE-MINOCA Mimicker (19% vs. 15%, p=0.043) but similar in AHA STE-MINOCA (17% vs. 15%, p=0.42) compared with STEMI-Obstruction.ConclusionsIn this large multicenter STEMI cohort, nearly 5% of patients presented with STE-MINOCA. At five years, mortality approached 20% among patients with STE-MINOCA. Despite the lower risk profile, STE-MINOCA patients were at 40% higher risk of 5-year all-cause mortality compared with STEMI-Obstruction. Additionally, 5-year all-cause mortality risk was higher in AHA STE-MINOCA Mimicker but similar in AHA STE-MINOCA compared to STEMI-Obstruction.
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- 2023
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25. Reproducibility of CMR in Patients With Cardiac Implantable Electrical Devices
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Mohammad R. Ostovaneh, Caroline Ward, Bharath Ambale-Venkatesh, Elzbieta Chamera, Yoko Kato, Roberto Bolli, Raul Mitrani, Emerson C. Perin, Timothy D. Henry, Joshua M. Hare, Lem Moyé, Saman Nazarian, and João A.C. Lima
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Radiology, Nuclear Medicine and imaging ,Cardiology and Cardiovascular Medicine - Published
- 2022
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26. Reducing system delays in treatment of ST elevation myocardial infarction and confronting the challenges of late presentation in low and middle-income countries
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Sameer Mehta, Christopher B. Granger, Timothy D. Henry, Cindy Lee Grines, Alexandra Lansky, Ivan Rokos, Roberto Botelho, Andreas Baumbach, Sundeep Mishra, Tan Huay Cheem, Damras Tresukosol, Robaayah Zambahari, Alexandra Ferré, and Marco Castillo
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Surgery ,RD1-811 ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Published
- 2017
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27. On-Treatment Platelet Reactivity and Ischemic Outcomes in Patients With Diabetes Mellitus: Two-Year Results From ADAPT-DES
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Bahira Shahim, Björn Redfors, Thomas D. Stuckey, Mengdan Liu, Zhipeng Zhou, Bernhard Witzenbichler, Giora Weisz, Michael J. Rinaldi, Franz‐Josef Neumann, D. Christopher Metzger, Timothy D. Henry, David A. Cox, Peter L. Duffy, Bruce R. Brodie, Iva Srdanovic, Mahesh V. Madhavan, Ernest L. Mazzaferri, Roxana Mehran, Ori Ben‐Yehuda, Ajay J. Kirtane, and Gregg W. Stone
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Cardiology and Cardiovascular Medicine - Abstract
Background Diabetes mellitus and high platelet reactivity (HPR) on clopidogrel are both associated with increased risk of ischemic events after percutaneous coronary intervention, but whether the HPR‐associated risk of adverse ischemic events differs by diabetes mellitus status is unknown. Methods and Results ADAPT‐DES (Assessment of Dual Antiplatelet Therapy With Drug‐Eluting Stents) was a prospective, multicenter registry of patients treated with coronary drug‐eluting stents. HPR was defined as P2Y12 reaction units >208 by the VerifyNow point‐of‐care assay. Cox multivariable analysis was used to assess whether HPR‐associated risk of major adverse cardiac events (MACE; cardiac death, myocardial infarction, or stent thrombosis) varied for patients with insulin‐treated diabetes mellitus (ITDM), non–ITDM, and no diabetes mellitus. Diabetes mellitus and HPR were included in an interaction analysis. Of 8582 patients enrolled, 2429 (28.3%) had diabetes mellitus, of whom 998 (41.1%) had ITDM. Mean P2Y12 reaction units were higher in patients with diabetes mellitus versus without diabetes mellitus, and HPR was more frequent in patients with diabetes mellitus. HPR was associated with consistently increased 2‐year rates of MACE in patients with and without diabetes mellitus ( P interaction =0.36). A significant interaction was present between HPR and non–insulin‐treated diabetes mellitus versus ITDM for 2‐year MACE (adjusted hazard ratio [HR] for non–ITDM, 2.28 [95% CI, 1.39–3.73] versus adjusted HR for ITDM, 1.02 [95% CI, 0.70–1.50]; P interaction =0.01). Conclusions HPR was more common in patients with diabetes mellitus and was associated with an increased risk of MACE in both patients with and without diabetes mellitus. In patients with diabetes mellitus, a more pronounced effect of HPR on MACE was present in lower‐risk non–ITDM patients than in higher‐risk patients with ITDM. Registration URL: https://clinicaltrials.gov/ct2/show/NCT00638794 ; Unique identifier: NCT00638794. ADAPT‐DES (Assessment of Dual Antiplatelet Therapy With Drug‐Eluting Stents).
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- 2022
28. 761 PRASUGREL OR CLOPIDOGREL IN PATIENTS WITH ACUTE CORONARY SYNDROMES AT DIFFERENT THROMBOTIC RISK: RESULTS FROM THE PROMETHEUS STUDY
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Mauro Chiarito, Davide Cao, Samantha Sartori, Zhongjie Zhang, Birgit Vogel, Johny Nicholas, Carlo Andrea Pivato, Alessandro Spirito, Annerieke Tavenier, Mark Effron, Giulio G Stefanini, Usman Baber, Samir Kapadia, Sunil Rao, Timothy D Henry, Stuart Pocock, George Dangas, Annapoorna Kini, and Roxana Mehran
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Cardiology and Cardiovascular Medicine - Abstract
Background Potent P2Y12 inhibitors are recommended in patients with acute coronary syndrome (ACS), although the optimal antithrombotic strategy should be tailored based on patients thrombotic and hemorrhagic risk profile. We evaluated if the benefits associated with prasugrel vs. clopidogrel in ACS patients undergoing percutaneous coronary intervention (PCI) are similar in patients with different thrombotic risk profiles. Methods PROMETHEUS was a multicenter observational study comparing prasugrel vs. clopidogrel in ACS patients undergoing PCI. Patients were defined at high thrombotic risk if presenting with a clinical and a procedural risk feature. The primary endpoint was major adverse cardiac events (MACE), composite of death, myocardial infarction, stroke, or unplanned revascularization. Hazard ratio (HR) and 95% confidence intervals (CI) were calculated using propensity-stratified analysis and with multivariable Cox regression. Results Among 16,065 patients, 4,293 were defined at high and 11,772 at low-to-moderate thrombotic risk. Patients receiving prasugrel had less comorbidities and risk factors than those treated with clopidogrel, both in the high and low-to-moderate thrombotic risk strata. High thrombotic risk patients had increased rates of ischemic and bleeding events at 90-day and 1-year follow-up. Patients treated with prasugrel had a lower adjusted 1-year risk of MACE (HR 0.86, 95% CI 0.77-0.96), irrespective of their thrombotic risk (pinteraction =0.32). Stratifying the study population by number of risk factors there was a significant interaction (pinteraction =0.026) for a greater reduction in MACE with prasugrel among patients with ≤1 thrombotic risk factor. The risk of clinically significant bleeding was similar in patients treated with prasugrel and clopidogrel. Conclusions Patients with ACS at high thrombotic risk who undergo PCI are at increased risk of adverse events at 1 year. Prasugrel, mainly reserved to patients with less comorbidities, reduced the risk of ischemic events both in patients at high and low-to-moderate thrombotic risk as compared with clopidogrel.
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- 2022
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29. Personalized vascular healthcare: insights from a large international survey
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Nick E J West, Maneesh Juneja, Natalia Pinilla, Koen R De Loose, Timothy D Henry, Connie S Baumgard, and Olga Kraineva
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Cardiology and Cardiovascular Medicine - Abstract
Fragmentation of healthcare systems through limited cross-speciality communication and intermittent, intervention-based care, without insight into follow-up and compliance, results in poor patient experiences and potentially contributes to suboptimal outcomes. Data-driven tools and novel technologies have the capability to address these shortcomings, but insights from all stakeholders in the care continuum remain lacking. A structured online questionnaire was given to respondents (n = 1432) in nine global geographies to investigate attitudes to the use of data and novel technologies in the management of vascular disease. Patients with coronary or peripheral artery disease (n = 961), physicians responsible for their care (n = 345), and administrators/healthcare leaders with responsibility for commissioning/procuring cardiovascular services (n = 126) were included. Narrative themes arising from the survey included patients’ desire for more personalized healthcare, shared decision-making, and improved communication. Patients, administrators, and physicians perceived and experienced deficiencies in continuity of care, and all acknowledged the potential for data-driven techniques and novel technologies to address some of these shortcomings. Further, physicians and administrators saw the ‘upstream’ segment of the care journey—before diagnosis, at point of diagnosis, and when determining treatment—as key to enabling tangible improvements in patient experience and outcomes. Finally, despite acceptance that data sharing is critical to the success of such interventions, there remains persistent issues related to trust and transparency. The current fragmented care continuum could be improved and streamlined through the adoption of advanced data analytics and novel technologies, including diagnostic and monitoring techniques. Such an approach could enable the refocusing of healthcare from intermittent contacts and intervention-only focus to a more holistic patient view.
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- 2022
30. Does the Effectiveness of a Medicine Copay Voucher Vary by Baseline Medication Out-Of-Pocket Expenses? Insights From ARTEMIS
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Jennifer A. Rymer, Lisa A. Kaltenbach, Eric D. Peterson, David J. Cohen, Gregg C. Fonarow, Niteesh K. Choudhry, Timothy D. Henry, Christopher P. Cannon, and Tracy Y. Wang
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Treatment Outcome ,Myocardial Infarction ,Purinergic P2Y Receptor Antagonists ,Humans ,Health Expenditures ,Cardiology and Cardiovascular Medicine ,Medication Adherence - Abstract
Background Persistence to P2Y12 inhibitors after myocardial infarction (MI) remains low. Out‐of‐pocket cost is cited as a factor affecting medication compliance. We examined whether a copayment intervention affected 1‐year persistence to P2Y12 inhibitors and clinical outcomes. Methods and Results In an analysis of ARTEMIS (Affordability and Real‐World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study), patients with MI discharged on a P2Y12 inhibitor were stratified by baseline out‐of‐pocket medication burden: low ($0–$49 per month), intermediate ($50–$149 per month), and high (≥$150 per month). The impact of the voucher intervention on 1‐year P2Y12 inhibitor persistence was examined using a logistic regression model with generalized estimating equations. We assessed the rates of major adverse cardiovascular events among the groups using a Kaplan–Meier estimator. Among 7351 MI‐treated patients at 282 hospitals, 54.2% patients were in the low copay group, 32.0% in the middle copay group, and 13.8% in the high copay group. Patients in higher copay groups were more likely to have a history of prior MI, heart failure, and diabetes compared with the low copay group (all P P interaction=0.42). Patients in the high copay group without a voucher had similar risk of 1‐year major adverse cardiovascular events compared with patients in the high copay group with a voucher (adjusted hazard ratio, 0.89 [95% CI, 0.66–1.21]). Conclusions Medication copayment vouchers were associated with higher medication persistence at 1 year following an MI, regardless of out‐of‐pocket medication burden. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02406677.
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- 2022
31. Cardiology Research Internship for Undergraduate Students Provides Unique Opportunity for Next Generation of Health Care Professionals
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Jay H. Traverse, Kevin M. Harris, Scott W. Sharkey, Monique North, Timothy D. Henry, Maia Hendel, Ross Garberich, David G. Hurrell, and Jan Dick
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education ,undergraduate ,Medical education ,research ,business.industry ,Quality Improvement Project ,Viewpoint ,female ,Internship ,Health care ,premedical ,Medicine ,Cardiology and Cardiovascular Medicine ,business - Published
- 2021
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32. A Phase <scp>II</scp> study of autologous mesenchymal stromal cells and c‐kit positive cardiac cells, alone or in combination, in patients with ischaemic heart failure: the <scp>CCTRN CONCERT‐HF</scp> trial
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Michael P. Murphy, Ketty Bacallao, Lara M. Simpson, Aisha Khan, Joshua M. Hare, Bharath Ambale-Venkatesh, Judy Bettencourt, Dejian Lai, David P. Lee, Gregory D. Lewis, Timothy D. Henry, Bangon Longsomboon, Ray F. Ebert, Keith L. March, Mohammad R. Ostovaneh, Michelle Cohen, Ivonne Hernandez Schulman, Rachel W. Vojvodic, Carl J. Pepine, Krystalenia Valasaki, Lem Moyé, Shelly L. Sayre, Sohail Ikram, Robert D. Simari, Doris A. Taylor, Catalin Loghin, James T. Willerson, Roberto Bolli, Phillip C. Yang, David Aguilar, Barry R. Davis, Emerson C. Perin, Connor O'Brien, Adrian P. Gee, Sara Richman, Joao A.C. Lima, Raul D. Mitrani, and Jay H. Traverse
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medicine.medical_specialty ,Minnesota ,Phases of clinical research ,030204 cardiovascular system & hematology ,Mesenchymal Stem Cell Transplantation ,Placebo ,Ventricular Function, Left ,03 medical and health sciences ,0302 clinical medicine ,Quality of life ,Internal medicine ,Humans ,Medicine ,Heart Failure ,Ejection fraction ,business.industry ,Mesenchymal stem cell ,Mesenchymal Stem Cells ,Stroke Volume ,medicine.disease ,Clinical trial ,Treatment Outcome ,Heart failure ,Quality of Life ,Cardiology ,Cardiology and Cardiovascular Medicine ,business ,Mace - Abstract
AIMS CONCERT-HF is an NHLBI-sponsored, double-blind, placebo-controlled, Phase II trial designed to determine whether treatment with autologous bone marrow-derived mesenchymal stromal cells (MSCs) and c-kit positive cardiac cells (CPCs), given alone or in combination, is feasible, safe, and beneficial in patients with heart failure (HF) caused by ischaemic cardiomyopathy. METHODS AND RESULTS Patients were randomized (1:1:1:1) to transendocardial injection of MSCs combined with CPCs, MSCs alone, CPCs alone, or placebo, and followed for 12 months. Seven centres enrolled 125 participants with left ventricular ejection fraction of 28.6 ± 6.1% and scar size 19.4 ± 5.8%, in New York Heart Association class II or III. The proportion of major adverse cardiac events (MACE) was significantly decreased by CPCs alone (-22% vs. placebo, P = 0.043). Quality of life (Minnesota Living with Heart Failure Questionnaire score) was significantly improved by MSCs alone (P = 0.050) and MSCs + CPCs (P = 0.023) vs. placebo. Left ventricular ejection fraction, left ventricular volumes, scar size, 6-min walking distance, and peak oxygen consumption did not differ significantly among groups. CONCLUSIONS This is the first multicentre trial assessing CPCs and a combination of two cell types from different tissues in HF patients. The results show that treatment is safe and feasible. Even with maximal guideline-directed therapy, both CPCs and MSCs were associated with improved clinical outcomes (MACE and quality of life, respectively) in ischaemic HF without affecting left ventricular function or structure, suggesting possible systemic or paracrine cellular mechanisms. Combining MSCs with CPCs was associated with improvement in both these outcomes. These results suggest potential important beneficial effects of CPCs and MSCs and support further investigation in HF patients.
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- 2021
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33. Initial Findings From the North American COVID-19 Myocardial Infarction Registry
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Santiago Garcia, Payam Dehghani, Cindy Grines, Laura Davidson, Keshav R. Nayak, Jacqueline Saw, Ron Waksman, John Blair, Bagai Akshay, Ross Garberich, Christian Schmidt, Hung Q. Ly, Scott Sharkey, Nestor Mercado, Carlos E. Alfonso, Naoki Misumida, Deepak Acharya, Mina Madan, Abdul Moiz Hafiz, Nosheen Javed, Jay Shavadia, Jay Stone, M. Chadi Alraies, Wah Htun, William Downey, Brian A. Bergmark, Jospeh Ebinger, Tareq Alyousef, Houman Khalili, Chao-Wei Hwang, Joshua Purow, Alexander Llanos, Brent McGrath, Mark Tannenbaum, Jon Resar, Rodrigo Bagur, Pedro Cox-Alomar, Ada C. Stefanescu Schmidt, Lindsey A. Cilia, Farouc A. Jaffer, Michael Gharacholou, Michael Salinger, Brian Case, Ameer Kabour, Xuming Dai, Osama Elkhateeb, Taisei Kobayashi, Hahn-Ho Kim, Mazen Roumia, Frank V. Aguirre, Jeffrey Rade, Aun-Yeong Chong, Hurst M. Hall, Shy Amlani, Alireza Bagherli, Rajan A.G. Patel, David A. Wood, Frederick G. Welt, Jay Giri, Ehtisham Mahmud, and Timothy D. Henry
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medicine.medical_specialty ,medicine.medical_treatment ,Myocardial Infarction ,030204 cardiovascular system & hematology ,Revascularization ,outcomes ,D2B, door to balloon ,PPCI, primary percutaneous coronary intervention ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Epidemiology ,PUI, person under investigation ,medicine ,Humans ,cardiovascular diseases ,030212 general & internal medicine ,Myocardial infarction ,Registries ,Young adult ,Prospective cohort study ,Stroke ,IQR, interquartile range ,Original Investigation ,COVID-19, coronavirus disease 2019 ,SCAI, Society for Cardiac Angiography and Interventions ,business.industry ,SARS-CoV-2 ,Percutaneous coronary intervention ,COVID-19 ,STEMI, ST-segment elevation myocardial infarction ,medicine.disease ,United States ,MI, myocardial infarction ,ST Elevation Myocardial Infarction ,Observational study ,ACC, American College of Cardiology ,Cardiology and Cardiovascular Medicine ,business ,ST-segment myocardial infarction - Abstract
Background The coronavirus disease 2019 (COVID-19) pandemic has impacted many aspects of ST-segment elevation myocardial infarction (STEMI) care, including timely access to primary percutaneous coronary intervention (PPCI). Objectives The goal of the NACMI (North American COVID-19 and STEMI) registry is to describe demographic characteristics, management strategies, and outcomes of COVID-19 patients with STEMI. Methods A prospective, ongoing observational registry was created under the guidance of 3 cardiology societies. STEMI patients with confirmed COVID+ (group 1) or suspected (person under investigation [PUI]) (group 2) COVID-19 infection were included. A group of age- and sex-matched STEMI patients (matched to COVID+ patients in a 2:1 ratio) treated in the pre-COVID era (2015 to 2019) serves as the control group for comparison of treatment strategies and outcomes (group 3). The primary outcome was a composite of in-hospital death, stroke, recurrent myocardial infarction, or repeat unplanned revascularization. Results As of December 6, 2020, 1,185 patients were included in the NACMI registry (230 COVID+ patients, 495 PUIs, and 460 control patients). COVID+ patients were more likely to have minority ethnicity (Hispanic 23%, Black 24%) and had a higher prevalence of diabetes mellitus (46%) (all p, Central Illustration
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- 2021
34. Increasing myocardial edema is associated with greater microvascular obstruction in ST-segment elevation myocardial infarction
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Nicole L. Bonfig, Chase R. Soukup, Ananya A. Shah, Susan Olet, Sarah J. Davidson, Christian W. Schmidt, Rose Peterson, Timothy D. Henry, and Jay H. Traverse
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Percutaneous Coronary Intervention ,Treatment Outcome ,Physiology ,Physiology (medical) ,Coronary Circulation ,Microcirculation ,Myocardium ,Reperfusion Injury ,Myocardial Infarction ,Edema ,Humans ,ST Elevation Myocardial Infarction ,Cardiology and Cardiovascular Medicine - Abstract
Patients with STEMI ( n = 385) had cardiac MRIs 2 to 3 days following reperfusion with primary PCI to determine the relationship between myocardial edema, LV mass, and MVO. We observed that MVO increased linearly with LV mass and that myocardial edema measured by T2-imaging also increased linearly with LV mass. Patients with MVO had greater edema and LVEDP than subjects without MVO. These findings suggest that myocardial edema which arises from ischemia-reperfusion injury may result in extravascular compression of the microcirculation manifested as MVO on cardiac MRI.
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- 2022
35. Position Statement on Vascular Access Safety for Percutaneous Devices in AMI Complicated by Cardiogenic Shock
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Abdulla A. Damluji, Behnam Tehrani, Shashank S. Sinha, Marc D. Samsky, Timothy D. Henry, Holger Thiele, Nick E.J. West, Fortunato F. Senatore, Alexander G. Truesdell, George D. Dangas, Nathaniel R. Smilowitz, Amit P. Amin, Adam D. deVore, Nader Moazami, Joaquin E. Cigarroa, Sunil V. Rao, Mitchell W. Krucoff, David A. Morrow, and Ian C. Gilchrist
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Treatment Outcome ,Shock, Cardiogenic ,Myocardial Infarction ,Humans ,Hemorrhage ,Heart-Assist Devices ,Cardiology and Cardiovascular Medicine ,United States - Abstract
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.
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- 2022
36. ALLogeneic Heart STem Cells to Achieve Myocardial Regeneration (ALLSTAR) Trial: Rationale and Design
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Tarun Chakravarty, Raj R. Makkar, Deborah D. Ascheim, Jay H. Traverse, Richard Schatz, Anthony Demaria, Gary S. Francis, Thomas J. Povsic, Rachel R. Smith, Joao A. Lima, Janice M. Pogoda, Linda Marbán, and Timothy D. Henry
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Medicine - Abstract
Autologous cardiosphere-derived cells (CDCs) were the first therapeutic modality to demonstrate myocardial regeneration with a decrease in scar size and an increase in viable, functional tissue. Widespread applicability of autologous CDC therapy is limited by the need for patient-specific myocardial biopsy, cell processing, and quality control, resulting in delays to therapy and inherent logistical and economic constraints. Preclinical data had demonstrated equivalent efficiency of allogeneic to autologous CDCs. The ALLogeneic Heart STem Cells to Achieve Myocardial Regeneration (ALLSTAR) trial is a multicenter randomized, double-blind, placebo-controlled phase 1/2 safety and efficacy trial of intracoronary delivery of allogeneic CDCs (CAP-1002) in patients with myocardial infarction (MI) and ischemic left ventricular dysfunction. The phase 1 safety cohort enrolled 14 patients in an open-label, nonrandomized, dose-escalation safety trial. The phase 2 trial is a doubleblind, randomized, placebo-controlled trial that will compare intracoronary CDCs to placebo in a 2:1 allocation and will enroll up to 120 patients. The primary endpoint for both phases is safety at 1 month. For phase 2, the primary efficacy endpoint is relative change from baseline in infarct size at 12 months, as assessed by magnetic resonance imaging. The ALLSTAR trial employs a “seamless” WOVE 1 design that enables continuous enrollment from phase 1 to phase 2 and will evaluate the safety of intracoronary administration of allogeneic CDCs and its efficacy in decreasing infarct size in post-MI patients.
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- 2017
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37. Ticagrelor Monotherapy Versus Dual-Antiplatelet Therapy After PCI
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Marco Valgimigli, Roxana Mehran, Anna Franzone, Bruno R. da Costa, Usman Baber, Raffaele Piccolo, Eùgene P. McFadden, Pascal Vranckx, Dominick J. Angiolillo, Sergio Leonardi, Davide Cao, George D. Dangas, Shamir R. Mehta, Patrick W. Serruys, C. Michael Gibson, Gabriel P. Steg, Samin K. Sharma, Christian Hamm, Richard Shlofmitz, Christoph Liebetrau, Carlo Briguori, Luc Janssens, Kurt Huber, Maurizio Ferrario, Vijay Kunadian, David J. Cohen, Aleksander Zurakowski, Keith G. Oldroyd, Han Yaling, Dariuz Dudek, Samantha Sartori, Brian Kirkham, Javier Escaned, Dik Heg, Stephan Windecker, Stuart Pocock, Peter Jüni, Patrick Serruys, Shamir Mehta, Michael C. Gibson, Adnan Kastrati, Mitchel Krucoff, Magnus E. Ohman, Paul Gurbel, Timothy D. Henry, David Moliterno, Dierik Heg, Eugene McFadden, Steven O. Marx, Bruce Darrow, Nicola Corvaja, Douglas DeStefano, Newsha Ghodsi, Jose Meller, Theresa Franklin-Bond, Jin Young Cha, Zaha Waseem, Giora Weisz, Ran Kornowski, Keith Oldroyd, Upendra Kaul, Bernhard Witzenbichler, Vladimir Dzavik, Robert Gil, Gennaro Sardella, Edouard Benit, Roberto Diletti, Marcello Dominici, Ton Slagboom, Paweł Buszman, Leonardo Bolognese, Carlo Tumscitz, Krzysztof Bryniarski, Adel Aminian, Mathias Vrolix, Ivo Petrov, Scot Garg, Christoph Naber, Janusz Prokopczuk, and Philippe Gabriel Steg
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medicine.medical_specialty ,Aspirin ,animal structures ,business.industry ,medicine.medical_treatment ,Hazard ratio ,Percutaneous coronary intervention ,030204 cardiovascular system & hematology ,Lower risk ,medicine.disease ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Internal medicine ,Conventional PCI ,medicine ,030212 general & internal medicine ,Cardiology and Cardiovascular Medicine ,business ,Ticagrelor ,Stroke ,medicine.drug - Abstract
Objectives The aim of this study was to compare ticagrelor monotherapy with dual-antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with drug-eluting stents. Background The role of abbreviated DAPT followed by an oral P2Y12 inhibitor after PCI remains uncertain. Methods Two randomized trials, including 14,628 patients undergoing PCI, comparing ticagrelor monotherapy with standard DAPT on centrally adjudicated endpoints were identified, and individual patient data were analyzed using 1-step fixed-effect models. The protocol was registered in PROSPERO ( CRD42019143120 ). The primary outcomes were the composite of Bleeding Academic Research Consortium type 3 or 5 bleeding tested for superiority and, if met, the composite of all-cause death, myocardial infarction, or stroke at 1 year, tested for noninferiority against a margin of 1.25 on a hazard ratio (HR) scale. Results Bleeding Academic Research Consortium type 3 or 5 bleeding occurred in fewer patients with ticagrelor than DAPT (0.9% vs. 1.7%, respectively; HR: 0.56; 95% confidence interval [CI]: 0.41 to 0.75; p Conclusions Ticagrelor monotherapy was associated with a lower risk for major bleeding compared with standard DAPT, without a concomitant increase in ischemic events.
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- 2021
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38. The ixCELL-DCM Trial: Rationale and Design
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Timothy D. Henry M.D., Gary L. Schaer, Anthony Demaria, David Recker, Ann E. Remmers, James Goodrich, and Amit N. Patel
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Medicine - Abstract
Ixmyelocel-T is an investigational patient-specific, expanded, multicellular therapy produced from a patient's own bone marrow. It is produced by selectively expanding two key types of bone marrow mononuclear cells (BM-MNCs), CD90 + mesenchymal stem cells (MSCs), and CD45 + CD14 + autofluorescent, alternatively activated macrophages. Earlier clinical trials suggested that intramyocardial ixmyelocel-T might improve clinical, functional, symptomatic, and quality of life outcomes in patients with ischemic dilated cardiomyopathy (IDCM). This ongoing randomized, double-blinded, placebo-controlled phase 2b trial (ixCELL-DCM) was designed to assess the efficacy, safety, and tolerability of catheter-based transendocardial injection of ixmyelocel-T in patients with heart failure due to IDCM. Patients ( N = 114) with New York Heart Association class III or IV symptomatic heart failure due to IDCM, who have left ventricular ejection fraction ≤35% and an automatic implantable cardioverter defibrillator, but are ineligible for revascularization procedures, were randomly assigned (1:1 ratio) to ixmyelocel-T or placebo (vehicle control). The primary efficacy endpoint is a composite of the total number of deaths, cardiovascular hospitalizations, or unplanned clinic visits to treat acutely decompensated heart failure during the 12 months following treatment administration. Secondary endpoints include the win ratio analysis for hierarchical occurrences of clinical events in the primary endpoint, total numbers of clinical events, left ventricular structure and function, and quality-of-life assessments. ixCELL-DCM is one of the largest cell therapy trials in heart failure patients to date and the first double-blinded, placebo-controlled study of ixmyelocel-T administered via transendocardial catheter-based injections in patients with heart failure secondary to IDCM.
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- 2016
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39. Advances in Cardiac Biological Therapies 2016
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Amit N. Patel and Timothy D. Henry
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Medicine - Published
- 2016
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40. Allogeneic Mesenchymal Cell Therapy in Anthracycline-Induced Cardiomyopathy Heart Failure Patients
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Sohail Ikram, Kathy D. Miller, Adrian P. Gee, Joshua M. Hare, Jay H. Traverse, Bharath Ambale-Venkatesh, Emerson C. Perin, Connor O'Brien, Judy Bettencourt, Ray F. Ebert, Timothy D. Henry, Roberto Bolli, Joao A.C. Lima, Carl J. Pepine, Dejian Lai, David P. Lee, Phillip C. Yang, Shelly L. Sayre, Keith L. March, Michelle Cohen, Lara M. Simpson, Sara Richman, Michael P. Murphy, Doris A. Taylor, Mohammad R. Ostovaneh, Lem Moyé, Raul D. Mitrani, Rachel W. Vojvodic, Robert D. Simari, Catalin Loghin, Jean-Bernard Durand, James T. Willerson, David Aguilar, and Barry R. Davis
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Oncology ,medicine.medical_specialty ,Chemotherapy ,Poor prognosis ,Anthracycline ,business.industry ,medicine.medical_treatment ,Mesenchymal stem cell ,Cardiomyopathy ,medicine.disease ,Internal medicine ,Heart failure ,medicine ,Stem cell ,Young adult ,Cardiology and Cardiovascular Medicine ,business - Abstract
Background Anthracycline-induced cardiomyopathy (AIC) may be irreversible with a poor prognosis, disproportionately affecting women and young adults. Administration of allogeneic bone marr...
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- 2020
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41. Management of Acute Myocardial Infarction During the COVID-19 Pandemic
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Timothy D. Henry, Amal Mattu, Frederick G.P. Welt, Ivan C. Rokos, Cindy L. Grines, John S. Rumsfeld, Perwaiz Meraj, Harold L. Dauerman, Rajiv Jauhar, Ajay J. Kirtane, Sunil V. Rao, Ehtisham Mahmud, and John C. Messenger
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education.field_of_study ,medicine.medical_specialty ,Referral ,business.industry ,Population ,Cardiomyopathy ,General Medicine ,Emergency department ,Disease ,030204 cardiovascular system & hematology ,medicine.disease ,03 medical and health sciences ,0302 clinical medicine ,Radiology Nuclear Medicine and imaging ,Conventional PCI ,Health care ,Emergency medicine ,medicine ,cardiovascular diseases ,030212 general & internal medicine ,Myocardial infarction ,Cardiology and Cardiovascular Medicine ,business ,education - Abstract
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.
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- 2020
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42. Intracoronary ALLogeneic heart STem cells to Achieve myocardial Regeneration (ALLSTAR): a randomized, placebo-controlled, double-blinded trial
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Eduardo Marbán, Linda Marbán, Rachel R Smith, Glenn Kowalchuk, Tarun Chakravarty, Thomas J. Povsic, Janice M. Pogoda, Konstantinos Malliaras, Gary S. Francis, Anthony N. DeMaria, Deborah D. Ascheim, Dean J. Kereiakes, Mohammad R. Ostovaneh, Joao A.C. Lima, Richard A. Schatz, Frank V. Aguirre, Timothy D. Henry, Raj Makkar, and Jay H. Traverse
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medicine.medical_specialty ,Cardiomyopathy ,030204 cardiovascular system & hematology ,Ventricular tachycardia ,Sudden death ,Ventricular Function, Left ,03 medical and health sciences ,0302 clinical medicine ,Double-Blind Method ,Internal medicine ,medicine ,Clinical endpoint ,Humans ,Myocardial infarction ,030304 developmental biology ,0303 health sciences ,Ejection fraction ,business.industry ,Hematopoietic Stem Cell Transplantation ,Heart ,Stroke Volume ,Dilated cardiomyopathy ,medicine.disease ,Treatment Outcome ,Heart failure ,Cardiology ,Cardiology and Cardiovascular Medicine ,business - Abstract
Aims Cardiosphere-derived cells (CDCs) are cardiac progenitor cells that exhibit disease-modifying bioactivity in various models of cardiomyopathy and in previous clinical studies of acute myocardial infarction (MI), dilated cardiomyopathy, and Duchenne muscular dystrophy. The aim of the study was to assess the safety and efficacy of intracoronary administration of allogeneic CDCs in the multicentre, randomized, double-blinded, placebo-controlled, intracoronary ALLogeneic heart STem cells to Achieve myocardial Regeneration (ALLSTAR) trial. Methods and results We enrolled patients 4 weeks to 12 months after MI, with left ventricular ejection fraction (LVEF) ≤45% and LV scar size ≥15% of LV mass by magnetic resonance imaging (MRI). A pre-specified interim analysis was performed when 6-month MRI data were available. The trial was subsequently stopped due to the low probability of detecting a significant treatment effect of CDCs based on the primary endpoint. Patients were randomly allocated in a 2:1 ratio to receive CDCs or placebo in the infarct-related artery by stop-flow technique. The primary safety endpoint was the occurrence, during 1-month post-intracoronary infusion, of acute myocarditis attributable to allogeneic CDCs, ventricular tachycardia- or ventricular fibrillation-related death, sudden unexpected death, or a major adverse cardiac event (death or hospitalization for heart failure or non-fatal MI or need for left ventricular assist device or heart transplant). The primary efficacy endpoint was the relative percentage change in infarct size at 12 months post-infusion as assessed by contrast-enhanced cardiac MRI. We randomly allocated 142 eligible patients of whom 134 were treated (90 to the CDC group and 44 to the placebo group). The mean baseline LVEF was 40% and the mean scar size was 22% of LV mass. No primary safety endpoint events occurred. There was no difference in the percentage change from baseline in scar size (P = 0.51) between CDCs and placebo groups at 6 months. Compared with placebo, there were significant reductions in LV end-diastolic volume (P = 0.02), LV end-systolic volume (P = 0.02), and N-terminal pro b-type natriuretic peptide (NT-proBNP) (P = 0.02) at 6 months in CDC-treated patients. Conclusion Intracoronary infusion of allogeneic CDCs in patients with post-MI LV dysfunction was safe but did not reduce scar size relative to placebo at 6 months. Nevertheless, the reductions in LV volumes and NT-proBNP reveal disease-modifying bioactivity of CDCs. Trial registration Clinicaltrials.gov identifier: NCT01458405.
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- 2020
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43. Cardiac Imaging in the Post-ISCHEMIA Trial Era
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Donna M. Polk, Raymond Y. Kwong, Farouc A. Jaffer, Mouaz H. Al-Mallah, Rob S. Beanlands, Ehtisham Mahmud, Sven Plein, Eike Nagel, Michael Salerno, David A. Cox, Timothy D. Henry, Colin Berry, Ron Blankstein, Patricia A. Pellikka, Partho P. Sengupta, Vasken Dilsizian, Paul A. Grayburn, John P Greenwood, Madhav Swaminathan, Kirk N. Garrett, Andrew E. Arai, Sunil V. Rao, Cindy Grines, William A. Zoghbi, Venkatesh L. Murthy, Dennis A. Calnon, James C. Carr, Sharmila Dorbala, Frank A. Flachskampf, Peter L. Duffy, Chiara Bucciarelli-Ducci, Leslee J. Shaw, Koen Nieman, Y S Chandrashekhar, Randall C. Thompson, Terrence D. Ruddy, Prem Soman, Thomas H. Marwick, Subha V. Raman, and Jonathan Leipsic
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medicine.medical_specialty ,business.industry ,Ischemia ,MEDLINE ,030204 cardiovascular system & hematology ,medicine.disease ,030218 nuclear medicine & medical imaging ,Clinical trial ,03 medical and health sciences ,Management strategy ,0302 clinical medicine ,medicine ,Radiology, Nuclear Medicine and imaging ,Cardiology and Cardiovascular Medicine ,business ,Intensive care medicine ,Medical therapy ,Cardiac imaging - Abstract
The highly anticipated ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) trial, the largest study to-date conducted to assess for the incremental clinical benefits of an initial invasive management strategy over an initial medical therapy
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- 2020
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44. Temporary Emergency Guidance to STEMI Systems of Care During the COVID-19 Pandemic
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Timothy D. Henry, Hani Jneid, Abhinav Goyal, Christopher B. Granger, Venu Menon, Michael Redlener, Mark Bieniarz, James G. Jollis, Jason N. Katz, Patricia J.M. Best, Alice K. Jacobs, General Cardiology, Gregg C. Fonarow, Murtuza J. Ali, Lori Hollowell, Jessica K. Zègre-Hemsey, Jacqueline E. Tamis-Holland, William J. French, Mauricio G. Cohen, and Peter J. Mason
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Consensus ,Coronavirus disease 2019 (COVID-19) ,medicine.medical_treatment ,Pneumonia, Viral ,Cardiology ,Risk Assessment ,STEMI ,Betacoronavirus ,Risk Factors ,Physiology (medical) ,Pandemic ,medicine ,Humans ,Pandemics ,Occupational Health ,Host Microbial Interactions ,SARS-CoV-2 ,business.industry ,percutaneous coronary intervention ,COVID-19 ,Percutaneous coronary intervention ,Frame of Reference ,American Heart Association ,Prognosis ,medicine.disease ,United States ,Perspective ,ST Elevation Myocardial Infarction ,Cardiology Service, Hospital ,Patient Safety ,Medical emergency ,Coronavirus Infections ,Emergency Service, Hospital ,Cardiology and Cardiovascular Medicine ,business ,Delivery of Health Care - Published
- 2020
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45. <scp>SCAI</scp> position statement on the performance of percutaneous coronary intervention in ambulatory surgical centers
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Joaquin E. Cigarroa, Timothy D. Henry, Richard W. Snyder, John C. Messenger, Peter L. Duffy, Jeffrey Carr, Sunil V. Rao, Deepali N. Tukaye, Binita Shah, Lyndon C. Box, James C. Blankenship, Issam D. Moussa, Lawrence Ang, and Ehtisham Mahmud
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Consensus ,Quality Assurance, Health Care ,Surgicenters ,medicine.medical_treatment ,Cardiology ,Psychological intervention ,Coronary Artery Disease ,030204 cardiovascular system & hematology ,Risk Assessment ,law.invention ,03 medical and health sciences ,Percutaneous Coronary Intervention ,0302 clinical medicine ,Randomized controlled trial ,Risk Factors ,law ,Humans ,Medicine ,Radiology, Nuclear Medicine and imaging ,cardiovascular diseases ,030212 general & internal medicine ,Reimbursement ,Quality Indicators, Health Care ,business.industry ,Percutaneous coronary intervention ,General Medicine ,medicine.disease ,Treatment Outcome ,surgical procedures, operative ,Conventional PCI ,Position paper ,Observational study ,Patient Safety ,Medical emergency ,Cardiology and Cardiovascular Medicine ,business ,Medicaid - Abstract
The Centers for Medicare & 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.
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- 2020
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46. Management of acute myocardial infarction during the <scp>COVID</scp> ‐19 pandemic
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Rajiv Jauhar, Sunil V. Rao, Amal Mattu, Cindy L. Grines, Perwaiz Meraj, John C. Messenger, Ivan C. Rokos, Ehtisham Mahmud, Ajay J. Kirtane, Frederick G.P. Welt, John S. Rumsfeld, Harold L. Dauerman, and Timothy D. Henry
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medicine.medical_specialty ,education.field_of_study ,business.industry ,medicine.medical_treatment ,Population ,Percutaneous coronary intervention ,General Medicine ,Emergency department ,030204 cardiovascular system & hematology ,medicine.disease ,03 medical and health sciences ,0302 clinical medicine ,Emergency medicine ,Health care ,medicine ,Myocardial infarction complications ,Radiology, Nuclear Medicine and imaging ,cardiovascular diseases ,030212 general & internal medicine ,Myocardial infarction ,Myocardial infarction diagnosis ,Disease management (health) ,Cardiology and Cardiovascular Medicine ,education ,business - Abstract
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 US population remains unknown with risk of asymptomatic spread. This document addresses the care of these patients focusing on (a) varied clinical presentations; (b) appropriate personal protection equipment (PPE) for health care workers; (c) the roles of the emergency department, emergency medical system, and the cardiac catheterization laboratory (CCL); and (4) regional STEMI systems of care. During the COVID-19 pandemic, primary percutaneous coronary intervention (PCI) remains the standard of care for STEMI patients at PCI-capable hospitals when it can be provided in a timely manner, 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.
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- 2020
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47. Catheterization Laboratory Considerations During the Coronavirus (COVID-19) Pandemic
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Sabeeda Kadavath, Michael N. Young, Anna E. Bortnick, Timothy D. Henry, Laura Davidson, Ajay J. Kirtane, Matthew W. Sherwood, Pinak B. Shah, Frederick G.P. Welt, Ehtisham Mahmud, and Herbert D. Aronow
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Cardiac Catheterization ,2019-20 coronavirus outbreak ,Infectious Disease Transmission, Patient-to-Professional ,Coronavirus disease 2019 (COVID-19) ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,Pneumonia, Viral ,coronavirus ,Myocardial Infarction ,Disease ,Suction ,030204 cardiovascular system & hematology ,medicine.disease_cause ,Article ,Resource Allocation ,STEMI ,03 medical and health sciences ,Percutaneous Coronary Intervention ,0302 clinical medicine ,catheterization laboratory ,Pandemic ,Health care ,Disease Transmission, Infectious ,Intubation, Intratracheal ,Humans ,Medicine ,030212 general & internal medicine ,Pandemics ,Personal Protective Equipment ,Coronavirus ,Aerosols ,Infection Control ,business.industry ,Patient Selection ,COVID-19 ,Virology ,Cardiopulmonary Resuscitation ,NSTEMI ,Practice Guidelines as Topic ,Coronavirus Infections ,business ,Cardiology and Cardiovascular Medicine ,Hospital Units - Abstract
Coronavirus disease 2019 (COVID-19) has placed an enormous strain on the health care systems of the nations where it has spread widely, with specific implications of the disease on practice in the catheterization laboratory. These implications include how we might modify practice for standard
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- 2020
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48. Clinical Characteristics and Outcomes of STEMI Patients With Cardiogenic Shock and Cardiac Arrest
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Timothy D. Henry, Mohamed Omer, Nicholas Burke, Michael Mooney, Emmanouil S. Brilakis, Ivan Chavez, Michael Megaly, Peter Eckman, Scott W. Sharkey, Yale Wang, Christian W. Schmidt, Jay H. Traverse, Ross Garberich, K. Hryniewicz, Mario Gössl, Santiago Garcia, Jason T. Henry, Paul Sorajja, and Jeffrey Tyler
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Male ,medicine.medical_specialty ,Time Factors ,medicine.medical_treatment ,Electric Countershock ,Shock, Cardiogenic ,Hospital mortality ,030204 cardiovascular system & hematology ,Risk Assessment ,03 medical and health sciences ,Percutaneous Coronary Intervention ,0302 clinical medicine ,Heart Rate ,Risk Factors ,Internal medicine ,Humans ,Medicine ,In patient ,Hospital Mortality ,Registries ,cardiovascular diseases ,030212 general & internal medicine ,Myocardial infarction ,Symptom onset ,Aged ,Retrospective Studies ,Aged, 80 and over ,Bundle branch block ,business.industry ,Cardiogenic shock ,Percutaneous coronary intervention ,Arrhythmias, Cardiac ,Middle Aged ,medicine.disease ,Heart Arrest ,Treatment Outcome ,surgical procedures, operative ,Conventional PCI ,Cardiology ,ST Elevation Myocardial Infarction ,Female ,Cardiology and Cardiovascular Medicine ,business - Abstract
This study sought to compare the clinical characteristics and long-term outcomes of patients with ST-segment elevation myocardial infarction (STEMI) with and without cardiogenic shock (CS) or cardiac arrest (CA) before percutaneous coronary intervention (PCI).Patients with STEMI complicated by CS or CA are underrepresented in STEMI registries.Consecutive patients with STEMI or new left bundle branch block within 24 h of symptom onset were included in a regional STEMI program comprising a PCI center (Minneapolis Heart Institute at Abbott Northwestern Hospital), 11 hospitals 60 miles from PCI center (zone 1), and 19 hospitals 60 to 210 miles from PCI center (zone 2). No patients were excluded. Patients were stratified based on the presence (+) or absence (-) of CS or CA before PCI. Patients with CA were further classified based on initial rhythm. Primary outcomes were in-hospital and 5-year mortality.Between March 2003 and December 2014, 4,511 STEMI patients were included in the regional program, including 398 (9%) with CS and 499 (11%) with CA. Hospital mortality was: CS+ and CA+, 44%; CS+ and CA-, 23%; CS- and CA+, 19%; and CS- and CA-, 2% (p 0.001). The 5-year survival probability for CS+ and CA+ patients was 0.69 (95% confidence interval: 0.61 to 0.76) and 0.89 (95% confidence interval: 0.84 to 0.93), respectively (p 0.01). Compared with patients with shockable rhythms, CA patients with nonshockable rhythms had significantly lower odds of survival at hospital discharge and at 5 years (both p 0.001).The combination of CS and CA significantly increases short-term mortality in patients with STEMI. After 5 years of follow-up, CS patients remained at high risk of fatal events, whereas the prognosis of CA patients was determined by initial rhythm at presentation.
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- 2020
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49. Definitions and Standardized Endpoints for Treatment of Coronary Bifurcations
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Mattia Lunardi, Yves Louvard, Thierry Lefèvre, Goran Stankovic, Francesco Burzotta, Ghassan S. Kassab, Jens F. Lassen, Olivier Darremont, Scot Garg, Bon-Kwon Koo, Niels R. Holm, Thomas W. Johnson, Manuel Pan, Yiannis S. Chatzizisis, Adrian Banning, Alaide Chieffo, Dariusz Dudek, David Hildick-Smith, Jérome Garot, Timothy D. Henry, George Dangas, Gregg W. Stone, Mitchell W. Krucoff, Donald Cutlip, Roxana Mehran, William Wijns, Faisal Sharif, Patrick W. Serruys, and Yoshinobu Onuma
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Heart Valve Prosthesis Implantation ,clinical trials ,Cardiac Catheterization ,Asia ,Academic Research Consortium ,endpoints ,Heart ,Coronary Artery Disease ,Coronary Angiography ,United States ,Europe ,Treatment Outcome ,bifurcation ,Settore MED/11 - MALATTIE DELL'APPARATO CARDIOVASCOLARE ,Humans ,Academic research consortium ,Cardiology and Cardiovascular Medicine - Abstract
The Bifurcation Academic Research Consortium (Bif-ARC) project originated from the need to overcome the paucity of standardization and comparability between studies involving bifurcation coronary lesions. This document is the result of a collaborative effort between academic research organizations and the most renowned interventional cardiology societies focused on bifurcation lesions in Europe, the United States, and Asia. This consensus provides standardized definitions for bifurcation lesions; the criteria to judge the side branch relevance; the procedural, mechanistic, and clinical endpoints for every type of bifurcation study; and the follow-up methods. Considering the complexity of bifurcation lesions and their evaluation, detailed instructions and technical aspects for site and core laboratory analysis of bifurcation lesions are also reported. The recommendations included within this consensus will facilitate pooled analyses and the effective comparison of data in the future, improving the clinical relevance of trials in bifurcation lesions, and the quality of care in this subset of patients.
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- 2022
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50. North American COVID-19 Myocardial Infarction (NACMI) Risk Score for Prediction of In-Hospital Mortality
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Payam Dehghani, Christian W. Schmidt, Santiago Garcia, Brynn Okeson, Cindy L. Grines, Avneet Singh, Rajan A.G. Patel, Jose Wiley, Wah Wah Htun, Keshav R. Nayak, M. Chadi Alraies, Nima Ghasemzadeh, Laura J. Davidson, Deepak Acharya, Jay Stone, Tareq Alyousef, Brian C. Case, Xuming Dai, Abdul Moiz Hafiz, Mina Madan, Faoruc A. Jaffer, Jay S. Shavadia, Ross Garberich, Akshay Bagai, Jyotpal Singh, Herbert D. Aronow, Nestor Mercado, and Timothy D. Henry
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In-hospital mortality in patients with ST-segment elevation myocardial infarction (STEMI) is higher in those with COVID-19 than in those without COVID-19. The factors that predispose to this mortality rate and their relative contribution are poorly understood. This study developed a risk score inclusive of clinical variables to predict in-hospital mortality in patients with COVID-19 and STEMI.Baseline demographic, clinical, and procedural data from patients in the North American COVID-19 Myocardial Infarction registry were extracted. Univariable logistic regression was performed using candidate predictor variables, and multivariable logistic regression was performed using backward stepwise selection to identify independent predictors of in-hospital mortality. Independent predictors were assigned a weighted integer, with the sum of the integers yielding the total risk score for each patient.In-hospital mortality occurred in 118 of 425 (28%) patients. Eight variables present at the time of STEMI diagnosis (respiratory rate of35 breaths/min, cardiogenic shock, oxygen saturation of93%, age of55 years, infiltrates on chest x-ray, kidney disease, diabetes, and dyspnea) were assigned a weighted integer. In-hospital mortality increased exponentially with increasing integer risk score (Cochran-Armitage χThe risk of in-hospital mortality in patients with COVID-19 and STEMI can be accurately predicted and discriminated using readily available clinical information.
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- 2022
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