Mitchell Wolfe Krucoff CV

Journal Article Cardiovasc Revasc Med · December 2024 In 2020, the NIH and FDA issued guidance documents that laid the foundation for human subject research during an unprecedented pandemic. To bridge these general considerations to actual applications in cardiovascular interventional device trials, the PAnde ... Full text Link to item Cite

Quantifying patients' preferences on tradeoffs between mortality risk and reduced need for target vessel revascularization for claudication.

Journal Article Vasc Med · December 2024 BACKGROUND: In 2019, the US Food and Drug Administration issued a warning that symptomatic relief from claudication using paclitaxel-coated devices might be associated with an increase in mortality over 5 years. We designed a discrete-choice experiment (DC ... Full text Link to item Cite

ACTION-ARC Pediatric and Adult Congenital Heart Disease Ventricular Assist Device Adverse Event Definitions-2023.

Journal Article ASAIO J · November 1, 2024 Adverse events (AEs) experienced by children and adults with congenital heart disease (CHD) on ventricular assist devices (VADs) are sometimes unique to these populations. The Advanced Cardiac Therapies Improving Outcomes Network (ACTION) and the Academic ... Full text Link to item Cite

Definitions of adverse events associated with extracorporeal membrane oxygenation in children: results of an international Delphi process from the ECMO-CENTRAL ARC.

Journal Article Lancet Child Adolesc Health · October 2024 Extracorporeal membrane oxygenation (ECMO) is a high-risk and low-volume life support with increasing clinical study. However, heterogenous outcome definitions impede data assimilation into evidence to guide practice. The Academic Research Consortium (ARC) ... Full text Link to item Cite

One-Month Versus Three-Month Dual-Antiplatelet Therapy in High Bleeding Risk Patients With Chronic Kidney Disease.

Journal Article Am J Cardiol · August 15, 2024 Shortening the duration of dual-antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) was shown to be effective and safe in patients at high bleeding risk (HBR). We aimed to investigate the effect of 1 versus 3-month DAPT on outcomes a ... Full text Link to item Cite

American Heart Association Cardiogenic Shock Registry: Design and Implementation.

Journal Article Circ Cardiovasc Qual Outcomes · July 2024 BACKGROUND: Cardiogenic shock is a morbid complication of heart disease that claims the lives of more than 1 in 3 patients presenting with this syndrome. Supporting a unique collaboration across clinical specialties, federal regulators, payors, and industr ... Full text Link to item Cite

Clinical outcomes with thin versus thick strut polymer-free biolimus-coated stents at 3 years.

Journal Article Open Heart · June 18, 2024 BACKGROUND: For high bleeding-risk patients (HBR) undergoing percutaneous coronary intervention (PCI), the LEADERS FREE (LF) and LEADERS FREE II (LF II) trials established the safety and efficacy of a stainless steel polymer-free biolimus-coated stent (SS- ... Full text Link to item Cite

Ticagrelor with or without aspirin following percutaneous coronary intervention in high-risk patients with concomitant peripheral artery disease: A subgroup analysis of the TWILIGHT randomized clinical trial.

Journal Article Am Heart J · June 2024 BACKGROUND: The optimal antiplatelet regimen after percutaneous coronary intervention (PCI) in patients with peripheral artery disease (PAD) is still debated. This analysis aimed to compare the effect of ticagrelor monotherapy versus ticagrelor plus aspiri ... Full text Link to item Cite

One- versus three-month dual antiplatelet therapy in high bleeding risk patients undergoing percutaneous coronary intervention for non-ST-segment elevation acute coronary syndromes.

Journal Article EuroIntervention · May 20, 2024 BACKGROUND: A short dual antiplatelet therapy (DAPT) duration has been proposed for patients at high bleeding risk (HBR) undergoing drug-eluting coronary stent (DES) implantation. Whether this strategy is safe and effective after a non-ST-segment elevation ... Full text Link to item Cite

Defining high bleeding risk in patients undergoing transcatheter aortic valve implantation: a VARC-HBR consensus document.

Journal Article EuroIntervention · May 10, 2024 The identification and management of patients at high bleeding risk (HBR) undergoing transcatheter aortic valve implantation (TAVI) are of major importance, but the lack of standardise ... Full text Link to item Cite

Prehospital crushed versus integral prasugrel loading dose in STEMI patients with a large myocardial area.

Journal Article EuroIntervention · April 1, 2024 BACKGROUND: The effect of administering a crushed prasugrel loading dose is uncertain in patients presenting with a large myocardial infarction and ST-segment elevation myocardial infarction (STEMI). AIMS: The aim of this study was to investigate if patien ... Full text Link to item Cite

1- Versus 3-Month DAPT in Older Patients at a High Bleeding Risk Undergoing PCI: Insights from the XIENCE Short DAPT Global Program.

Journal Article Am J Cardiol · March 1, 2024 This analysis aimed to evaluate the effect of 1- versus 3-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in older patients. Data from 3 prospective, single-arm studies (XIENCE Short DAPT Program), including patients w ... Full text Link to item Cite

Outcomes After Complex PCI With COMBO Stent Implantation: Insights from a Real-World Pooled Dataset.

Journal Article Am J Cardiol · December 15, 2023 Full text Link to item Cite

Clinically Driven Revascularization in High-Risk Patients Treated With Ticagrelor Monotherapy After PCI: Insights from the Randomized TWILIGHT Trial.

Journal Article Am J Cardiol · December 1, 2023 Repeat coronary revascularization is a common adverse event after successful percutaneous coronary intervention. This analysis aimed to assess the effects of ticagrelor monotherapy on repeat clinically driven revascularization (CDR). In the TWILIGHT (Ticag ... Full text Link to item Cite

Consensus minimum core data elements adapted to peripheral vascular intervention in the drug-eluting era: Consensus report from the Registry Assessment of Peripheral Interventional Devices (RAPID) Pathways "LEAN" working group.

Journal Article J Vasc Surg · November 2023 Registry Assessment of Peripheral Interventional Devices (RAPID) initiated the Pathways Program to provide a transparent, collaborative forum in which to pursue insights into multiple unresolved questions on benefit-risk of paclitaxel-coated devices, inclu ... Full text Link to item Cite

1- or 3-Month DAPT in Patients With HBR With or Without Oral Anticoagulant Therapy After PCI.

Journal Article JACC Cardiovasc Interv · October 23, 2023 BACKGROUND: The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in patients on long-term oral anticoagulation (OAC) therapy is still uncertain. OBJECTIVES: The aim of this analysis was to assess the effec ... Full text Link to item Cite

Dyspnea-Related Ticagrelor Discontinuation After Percutaneous Coronary Intervention.

Journal Article JACC Cardiovasc Interv · October 23, 2023 BACKGROUND: Nearly 20% of patients on ticagrelor experience dyspnea, which may lead to treatment discontinuation in up to one-third of cases. OBJECTIVES: The authors sought to evaluate the incidence, predictors, and outcomes of dyspnea-related ticagrelor d ... Full text Link to item Cite

Direct Stenting versus Conventional Stenting in Patients with ST-Segment Elevation Myocardial Infarction-A COMPARE CRUSH Sub-Study.

Journal Article J Clin Med · October 20, 2023 BACKGROUND: Direct stenting (DS) compared with conventional stenting (CS) after balloon predilatation may reduce distal embolization during percutaneous coronary intervention (PCI), thereby improving tissue reperfusion. In contrast, DS may increase the ris ... Full text Link to item Cite

Standardized Definitions for Cardiogenic Shock Research and Mechanical Circulatory Support Devices: Scientific Expert Panel From the Shock Academic Research Consortium (SHARC).

Journal Article Circulation · October 3, 2023 The Shock Academic Research Consortium is a multi-stakeholder group, including representatives from the US Food and Drug Administration and other government agencies, industry, and payers, convened to develop pragmatic consensus definitions useful for the ... Full text Link to item Cite

The 'chessboard of healing strategies': A cardiological application.

Journal Article J Eval Clin Pract · October 2023 RATIONALE: The question of how to adaptively cope with chronic illnesses, aging, and other sources of bodily impairment is crucial for patients and clinicians alike, though sometimes overlooked in the focus on biomedical treatment. AIMS AND OBJECTIVES: To ... Full text Link to item Cite

Bleeding and Ischemic Risks of Ticagrelor Monotherapy After Coronary Interventions.

Journal Article J Am Coll Cardiol · August 22, 2023 BACKGROUND: In TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention), among high-risk patients undergoing percutaneous coronary intervention (PCI), ticagrelor monotherapy vs continuation of dual antiplatelet therapy ... Full text Link to item Cite

Biolimus-eluting vs. other limus-eluting stents in NSTE-ACS: A pooled analysis of GLASSY and TWILIGHT.

Journal Article Int J Cardiol · July 15, 2023 BACKGROUND: Biodegradable polymer biolimus-eluting stents (BP-BES) may be associated with better outcomes in patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI) compared to other current-generation limus-eluting ... Full text Link to item Cite

Global Medical Device Clinical Trials Involving Both the United States and Japan: Key Considerations for Development, Regulatory Approval, and Conduct.

Journal Article Cardiovasc Revasc Med · July 2023 As medical device development becomes increasingly global, the opportunities and potential advantages offered by international clinical trial and regulatory approval strategies are also growing. In particular, medical device clinical trials involving sites ... Full text Link to item Cite

Minimum Core Data Elements for Transcatheter Mitral Therapies: Scientific Statement by PASSION CV, HVC, and TVTR.

Journal Article JACC Cardiovasc Interv · June 26, 2023 Mitral regurgitation is the most common valvular disease and is estimated to affect over 5 million Americans. Real-world data collection contributes to safety and effectiveness evidence for the U.S. Food and Drug Administration, quality evaluation for the ... Full text Link to item Cite

Defining Strategies of Modulation of Antiplatelet Therapy in Patients With Coronary Artery Disease: A Consensus Document from the Academic Research Consortium.

Journal Article Circulation · June 20, 2023 Antiplatelet therapy is the mainstay of pharmacologic treatment to prevent thrombotic or ischemic events in patients with coronary artery disease treated with percutaneous coronary intervention and those treated medically for an acute coronary syndrome. Th ... Full text Link to item Cite

Sex-stratified differences in early antithrombotic treatment response in patients presenting with ST-segment elevation myocardial infarction.

Journal Article Am Heart J · April 2023 BACKGROUND: The mechanisms underlying the increased risk of bleeding that female patients with ST-segment Elevation Myocardial Infarction (STEMI) exhibit, remains unclear. The present report assessed sex-related differences in response to pre-hospital dual ... Full text Link to item Cite

The mega COMBO collaboration: An individual patient data pooled analysis of patients undergoing PCI with COMBO stent.

Journal Article Int J Cardiol · January 1, 2023 BACKGROUND: COMBO (OrbusNeich Medical, Hong Kong) is a dual-therapy coronary stent featuring sirolimus as antiproliferative drug and an anti-CD34+ antibody coating to attract endothelial progenitor cells favoring rapid stent re-endothelization. The Mega CO ... Full text Link to item Cite

Ticagrelor with and without aspirin in patients with a prior coronary artery bypass graft undergoing percutaneous coronary intervention: the TWILIGHT-CABG study.

Journal Article EuroIntervention · December 2, 2022 BACKGROUND: Prior coronary artery bypass graft surgery (CABG) patients undergoing percutaneous coronary intervention (PCI) are often older and present with multiple comorbidities. Ticagrelor monotherapy after a short course of dual antiplatelet therapy (DA ... Full text Link to item Cite

One-Year Follow-Up of Vascular Intervention Trials Disrupted by the COVID-19 Pandemic: A Use-Case landscape.

Journal Article Cardiovasc Revasc Med · December 2022 INTRODUCTION: The COVID-19 pandemic had an unprecedented impact on cardiovascular clinical research. The decision-making and state of study operations in cardiovascular trials 1-year after interruption has not been previously described. METHODS: In the spr ... Full text Link to item Cite

Position Statement on Vascular Access Safety for Percutaneous Devices in AMI Complicated by Cardiogenic Shock.

Journal Article JACC Cardiovasc Interv · October 24, 2022 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 biv ... Full text Link to item Cite

Bleeding and Ischemic Outcomes With Ticagrelor Monotherapy According to Body Mass Index.

Journal Article JACC Cardiovasc Interv · October 10, 2022 BACKGROUND: There is a paucity of data regarding the safety and efficacy of different antiplatelet regimens according to standardized body mass index (BMI) categories. OBJECTIVES: The aim of this study was to investigate bleeding and ischemic outcomes acco ... Full text Link to item Cite

Pre-hospital treatment with crushed versus integral tablets of prasugrel in patients presenting with ST-Segment Elevation Myocardial Infarction-1-year follow-up results of the COMPARE CRUSH trial.

Journal Article Am Heart J · October 2022 The present research letter reports the 1-year clinical outcomes of the randomized COMPARE CRUSH trial, which allocated STEMI patients at first medical contact in the ambulance to receive either crushed or integral tablets of prasugrel loading dose. This t ... Full text Link to item Cite

Ticagrelor monotherapy after PCI in patients with concomitant diabetes mellitus and chronic kidney disease: TWILIGHT DM-CKD.

Journal Article Eur Heart J Cardiovasc Pharmacother · September 29, 2022 AIMS: We aimed to evaluate the treatment effects of ticagrelor monotherapy in the very high risk cohort of patients with concomitant diabetes mellitus (DM) and chronic kidney disease (CKD) undergoing percutaneous coronary intervention (PCI). METHODS AND RE ... Full text Link to item Cite

ARC-HBR criteria and TAVR: not all high bleeding risk patients look alike.

Journal Article EuroIntervention · August 19, 2022 Full text Link to item Cite

Reply: Improving the Patient Relevance and Generalizability of TAVR Core Data Elements.

Journal Article JACC Cardiovasc Interv · July 11, 2022 Full text Link to item Cite

Definitions and Standardized Endpoints for Treatment of Coronary Bifurcations.

Journal Article J Am Coll Cardiol · July 5, 2022 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 effo ... Full text Link to item Cite

Randomized evaluation of vessel preparation with orbital atherectomy prior to drug-eluting stent implantation in severely calcified coronary artery lesions: Design and rationale of the ECLIPSE trial.

Journal Article Am Heart J · July 2022 BACKGROUND: Severe coronary artery calcification has been associated with stent underexpansion, procedural complications, and increased rates of early and late adverse clinical events in patients undergoing percutaneous coronary intervention. To date, no l ... Full text Link to item Cite

Conversations in cardiology: Late career transitions-Retool, retire, refocus.

Journal Article Catheter Cardiovasc Interv · June 2022 Full text Link to item Cite

Minimum Core Data Elements for Evaluation of TAVR: A Scientific Statement by PASSION CV, HVC, and TVT Registry.

Journal Article JACC Cardiovasc Interv · April 11, 2022 Transcatheter aortic valve replacement (TAVR) is the standard of care for severe, symptomatic aortic stenosis. Real-world TAVR data collection contributes to benefit/risk assessment and safety evidence for the U.S. Food and Drug Administration, quality eva ... Full text Link to item Cite

Device and Procedure Relatedness: Viewpoint From Members of the ARC Steering Group.

Journal Article JACC Cardiovasc Interv · April 11, 2022 Full text Link to item Cite

Japan-USA Orbital Atherectomy for Calcific Coronary Lesions: COAST Study, Harmonization by Doing Proof-of-Concept.

Journal Article Cardiovasc Revasc Med · April 2022 Effective treatment strategies and medical devices continue to be needed in Japan and the United States of America (US) to mitigate the growing burden of cardiovascular disease and coronary heart disease. Unfortunately, there can be a delay in gaining card ... Full text Link to item Cite

Ticagrelor With or Without Aspirin in Chinese Patients Undergoing Percutaneous Coronary Intervention: A TWILIGHT China Substudy.

Journal Article Circ Cardiovasc Interv · April 2022 BACKGROUND: The risk/benefit tradeoff of dual antiplatelet therapy after percutaneous coronary intervention may vary in East Asian patients as compared with their non-East Asian counterparts. METHODS: The double-blind, placebo-controlled, randomized TWILIG ... Full text Link to item Cite

Safety and efficacy of ticagrelor monotherapy according to drug-eluting stent type: the TWILIGHT-STENT study.

Journal Article EuroIntervention · March 18, 2022 BACKGROUND: In the TWILIGHT trial, ticagrelor monotherapy after a short course of dual antiplatelet therapy (DAPT) was shown to be a safe bleeding avoidance strategy in high-risk patients undergoing percutaneous coronary intervention (PCI) with drug-elutin ... Full text Link to item Cite

Clinical Trial Design Principles and Outcomes Definitions for Device-Based Therapies for Hypertension: A Consensus Document From the Hypertension Academic Research Consortium.

Journal Article Circulation · March 15, 2022 The clinical implications of hypertension in addition to a high prevalence of both uncontrolled blood pressure and medication nonadherence promote interest in developing device-based approaches to hypertension treatment. The expansion of device-based thera ... Full text Link to item Cite

Ticagrelor Monotherapy After PCI in High-Risk Patients With Prior MI: A Prespecified TWILIGHT Substudy.

Journal Article JACC Cardiovasc Interv · February 14, 2022 OBJECTIVES: The aim of this study was to evaluate if patients with prior myocardial infarction (MI) could benefit from ticagrelor monotherapy in terms of bleeding reduction without any compromise in ischemic event prevention. BACKGROUND: Patients with hist ... Full text Link to item Cite

Quantifying Benefit-Risk Preferences for Heart Failure Devices: A Stated-Preference Study.

Journal Article Circ Heart Fail · January 2022 BACKGROUND: Regulatory and clinical decisions involving health technologies require judgements about relative importance of their expected benefits and risks. We sought to quantify heart-failure patients' acceptance of therapeutic risks in exchange for imp ... Full text Link to item Cite

Developing minimum core data structure for the obesity devices Coordinated Registry Network (CRN).

Journal Article BMJ Surg Interv Health Technol · 2022 Obesity continues to be a major public health issue, with more than two-thirds of adults in the USA categorized as overweight or obese. Bariatric surgery is effective and yields durable weight loss; however, few qualified candidates choose to undergo surgi ... Full text Open Access Link to item Cite

Ticagrelor monotherapy in patients with chronic kidney disease undergoing percutaneous coronary intervention: TWILIGHT-CKD.

Journal Article Eur Heart J · December 1, 2021 AIMS: The aim of this study was to assess the impact of chronic kidney disease (CKD) on the safety and efficacy of ticagrelor monotherapy among patients undergoing percutaneous coronary intervention (PCI). METHODS AND RESULTS: In this prespecified subanaly ... Full text Link to item Cite

Ticagrelor monotherapy in patients at high bleeding risk undergoing percutaneous coronary intervention: TWILIGHT-HBR.

Journal Article Eur Heart J · December 1, 2021 AIMS: Patients at high bleeding risk (HBR) represent a prevalent subgroup among those undergoing percutaneous coronary intervention (PCI). Early aspirin discontinuation after a short course of dual antiplatelet therapy (DAPT) has emerged as a bleeding avoi ... Full text Link to item Cite

Duration of Dual Antiplatelet Therapy for Patients at High Bleeding Risk Undergoing PCI.

Journal Article J Am Coll Cardiol · November 23, 2021 BACKGROUND: The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) among patients at high bleeding risk (HBR) is unknown. OBJECTIVES: The purpose of this analysis was to compare 1 vs 3 months of DAPT in HBR ... Full text Link to item Cite

Comparative influence of bleeding and ischemic risk factors on diabetic patients undergoing percutaneous coronary intervention with everolimus-eluting stents.

Journal Article Catheter Cardiovasc Interv · November 15, 2021 OBJECTIVE: To investigate the impact of ischemic and bleeding risk factors on long-term clinical outcomes of patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention (PCI) with everolimus-eluting stents. BACKGROUND: Second-generat ... Full text Link to item Cite

3- or 1-Month DAPT in Patients at High Bleeding Risk Undergoing Everolimus-Eluting Stent Implantation.

Journal Article JACC Cardiovasc Interv · September 13, 2021 OBJECTIVES: The aim of this study was to evaluate 2 abbreviated dual-antiplatelet therapy (DAPT) regimens in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI). BACKGROUND: Current-generation drug-eluting stents are pr ... Full text Link to item Cite

Sex Differences Among Patients With High Risk Receiving Ticagrelor With or Without Aspirin After Percutaneous Coronary Intervention: A Subgroup Analysis of the TWILIGHT Randomized Clinical Trial.

Journal Article JAMA Cardiol · September 1, 2021 IMPORTANCE: Shortened dual antiplatelet therapy followed by potent P2Y12 receptor inhibitor monotherapy reduces bleeding without increasing ischemic events after percutaneous coronary intervention (PCI). OBJECTIVE: To explore sex differences and evaluate t ... Full text Link to item Cite

Toward a better system for the sustainable development of objective performance goals for peripheral vascular interventions.

Journal Article J Vasc Surg · September 2021 Full text Link to item Cite

Impact of renal function in high bleeding risk patients undergoing percutaneous coronary intervention: a patient-level stratified analysis from four post-approval studies.

Journal Article J Thromb Thrombolysis · August 2021 Data on ischemic and bleeding outcomes after percutaneous coronary intervention (PCI) in high bleeding risk (HBR) patients with chronic kidney disease (CKD) are scarce. We aimed to evaluate the association between CKD and ischemic and bleeding outcomes in ... Full text Link to item Cite

Impact of Age on the Safety and Efficacy of Ticagrelor Monotherapy in Patients Undergoing PCI.

Journal Article JACC. Cardiovascular interventions · July 2021 ObjectivesThe aim of this study was to assess the impact of age on the safety and efficacy of ticagrelor monotherapy after percutaneous coronary intervention (PCI).BackgroundAs the risk for bleeding and ischemic complications after PCI in ... Full text Cite

Pharmacodynamic Effects of Pre-Hospital Administered Crushed Prasugrel in Patients With ST-Segment Elevation Myocardial Infarction.

Journal Article JACC Cardiovasc Interv · June 28, 2021 OBJECTIVES: This study sought to compare the pharmacodynamic effects of pre-hospitally administered P2Y12 inhibitor prasugrel in crushed versus integral tablet formulation in patients with ST-segment elevation myocardial infarction (STEMI) undergoing prima ... Full text Link to item Cite

Drug-coated stents versus bare metal stents in Academic Research Consortium-defined high bleeding risk patients.

Journal Article EuroIntervention · June 25, 2021 BACKGROUND: More effective and progressively safer generations of drug-elut-ing stents (DES) have replaced bare metal stents (BMS) in rou-tine clinical practice. However, patients considered to be at high bleeding risk (HBR) have traditionally been underre ... Full text Link to item Cite

Registry Assessment of Peripheral Interventional Devices objective performance goals for superficial femoral and popliteal artery peripheral vascular interventions.

Journal Article J Vasc Surg · May 2021 BACKGROUND: The Superficial Femoral Artery-Popliteal EvidencE Development Study Group developed contemporary objective performance goals (OPGs) for peripheral vascular interventions (PVI) for superficial femoral artery (SFA)-popliteal artery disease using ... Full text Link to item Cite

Assessing the Risks of Bleeding vs Thrombotic Events in Patients at High Bleeding Risk After Coronary Stent Implantation: The ARC-High Bleeding Risk Trade-off Model.

Journal Article JAMA Cardiol · April 1, 2021 IMPORTANCE: Patients who are candidates for percutaneous coronary intervention (PCI) and are at high bleeding risk constitute a therapeutic challenge because they often also face an increased risk of thrombotic complications. OBJECTIVES: To develop and val ... Full text Link to item Cite

Ticagrelor Monotherapy Versus Dual-Antiplatelet Therapy After PCI: An Individual Patient-Level Meta-Analysis.

Journal Article JACC Cardiovasc Interv · February 22, 2021 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 inhibi ... Full text Link to item Cite

Survival and Causes of Death Among Veterans With Lower Extremity Revascularization With Paclitaxel-Coated Devices: Insights From the Veterans Health Administration.

Journal Article J Am Heart Assoc · February 16, 2021 BACKGROUND The long-term safety of paclitaxel-coated devices (PCDs; drug-coated balloon or drug-eluting stent) for peripheral endovascular intervention is uncertain. We used data from the Veterans Health Administration to evaluate the association between P ... Full text Link to item Cite

Definitions and Clinical Trial Design Principles for Coronary Artery Chronic Total Occlusion Therapies: CTO-ARC Consensus Recommendations.

Journal Article Circulation · February 2, 2021 Over the past 2 decades, chronic total occlusion (CTO) percutaneous coronary intervention has developed into its own subspecialty of interventional cardiology. Dedicated terminology, techniques, devices, courses, and training programs have enabled progress ... Full text Link to item Cite

Important considerations for trials for peripheral arterial disease: Lessons learned from the paclitaxel mortality signal: A report on behalf of the registry assessment for peripheral interventional Devices (RAPID) Paclitaxel Pathways Program.

Journal Article Am Heart J · February 2021 The Registry Assessment of Peripheral Devices (RAPID) convened a multidisciplinary group of stakeholders including clinicians, academicians, regulators and industry representatives to conduct an in-depth review of limitations associated with the data avail ... Full text Link to item Cite

Effect of Prehospital Crushed Prasugrel Tablets in Patients With ST-Segment-Elevation Myocardial Infarction Planned for Primary Percutaneous Coronary Intervention: The Randomized COMPARE CRUSH Trial.

Journal Article Circulation · December 15, 2020 BACKGROUND: Early treatment with a potent oral platelet P2Y12 inhibitor is recommended in patients presenting with ST-segment-elevation myocardial infarction scheduled to undergo primary percutaneous coronary intervention (pPCI). The impact on coronary rep ... Full text Link to item Cite

Standardized definitions for evaluation of heart failure therapies: scientific expert panel from the Heart Failure Collaboratory and Academic Research Consortium.

Journal Article Eur J Heart Fail · December 2020 The Heart Failure Academic Research Consortium is a partnership between the Heart Failure Collaboratory (HFC) and Academic Research Consortium (ARC), comprised of leading heart failure (HF) academic research investigators, patients, United States (US) Food ... Full text Link to item Cite

Cardiac safety research consortium "shock II" think tank report: Advancing practical approaches to generating evidence for the treatment of cardiogenic shock.

Journal Article American heart journal · December 2020 Full text Cite

Standardized Definitions for Evaluation of Heart Failure Therapies: Scientific Expert Panel From the Heart Failure Collaboratory and Academic Research Consortium.

Journal Article JACC. Heart failure · December 2020 The Heart Failure Academic Research Consortium is a partnership between the Heart Failure Collaboratory (HFC) and Academic Research Consortium (ARC), comprised of leading heart failure (HF) academic research investigators, patients, United States (US) Food ... Full text Cite

Methodological and Regulatory Considerations for Updated Guidance on the Pressor Effects of Drugs.

Journal Article Ther Innov Regul Sci · November 2020 Elevated blood pressure increases the risk of adverse cardiovascular events and death. Accordingly, characterizing the off-target blood pressure effects of drugs is an important component of regulatory benefit-risk assessment and post-marketing clinical de ... Full text Link to item Cite

Ticagrelor alone vs. ticagrelor plus aspirin following percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes: TWILIGHT-ACS.

Journal Article European heart journal · October 2020 AimsThe aim of this study was to determine the effect of ticagrelor monotherapy on clinically relevant bleeding and major ischaemic events in relation to clinical presentation with and without non-ST elevation acute coronary syndromes (NSTE-ACS) a ... Full text Cite

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

Journal Article J Am Coll Cardiol · September 22, 2020 Investigating the balance of risk for thrombotic and bleeding events after percutaneous coronary intervention (PCI) is especially relevant for patients at high bleeding risk (HBR). The Academic Research Consortium for HBR recently proposed a consensus defi ... Full text Link to item Cite

SUPPORT-1 (Subjects Undergoing PCI and Perioperative Reperfusion Treatment): A Prospective, Randomized Trial of CMX-2043 in Patients Undergoing Elective Percutaneous Coronary Intervention.

Journal Article J Cardiovasc Pharmacol · August 2020 OBJECTIVE: The natural molecule α-lipoic acid has been shown to be partially cytoprotective through antioxidant and antiapoptotic mechanisms. To obtain an initial assessment of the safety and potential efficacy of a synthetic derivative, CMX-2043, in preve ... Full text Link to item Cite

Validation of the Academic Research Consortium High Bleeding Risk Definition in Contemporary PCI Patients.

Journal Article J Am Coll Cardiol · June 2, 2020 BACKGROUND: Bleeding following percutaneous coronary intervention has important prognostic implications. The Academic Research Consortium (ARC) recently proposed a list of clinical criteria to define patients at high bleeding risk (HBR). OBJECTIVES: This s ... Full text Link to item Cite

COMPARison of pre-hospital CRUSHed vs. uncrushed Prasugrel tablets in patients with STEMI undergoing primary percutaneous coronary interventions: Rationale and design of the COMPARE CRUSH trial.

Journal Article Am Heart J · June 2020 BACKGROUND: Dual antiplatelet therapy constitutes the cornerstone of medical treatment in patients with ST elevation myocardial infarction (STEMI). However, oral antiplatelet agents, such as prasugrel or ticagrelor, are characterized by slow gastrointestin ... Full text Link to item Cite

Defining the path ahead for NOAC use in the pediatric population: A Cardiac Safety Research Consortium Think Tank.

Journal Article Am Heart J · June 2020 Full text Link to item Cite

Cardiac remodeling after large ST-elevation myocardial infarction in the current therapeutic era.

Journal Article Am Heart J · May 2020 BACKGROUND: The evolution and clinical impact of cardiac remodeling after large ST-elevation myocardial infarction (STEMI) is not well delineated in the current therapeutic era. METHODS: The PRESERVATION I trial longitudinally assessed cardiac structure an ... Full text Link to item Cite

Sex-Related Differences in Patients at High Bleeding Risk Undergoing Percutaneous Coronary Intervention: A Patient-Level Pooled Analysis From 4 Postapproval Studies.

Journal Article J Am Heart Assoc · April 7, 2020 Background Women have been associated with higher rates of recurrent events after percutaneous coronary intervention than men, possibly attributable to advanced age at presentation and greater comorbidities. These factors also put women at higher risk of b ... Full text Link to item Cite

Bleeding Risk, Dual Antiplatelet Therapy Cessation, and Adverse Events After Percutaneous Coronary Intervention: The PARIS Registry.

Journal Article Circ Cardiovasc Interv · April 2020 BACKGROUND: Whether the underlying risk of bleeding influences the associations between patterns of dual antiplatelet therapy (DAPT) cessation and adverse events after percutaneous coronary intervention is unknown. METHODS: Patients enrolled in the prospec ... Full text Link to item Cite

Global Approach to High Bleeding Risk Patients With Polymer-Free Drug-Coated Coronary Stents: The LF II Study.

Journal Article Circ Cardiovasc Interv · April 2020 BACKGROUND: High bleeding risk (HBR) patients undergoing percutaneous coronary intervention have been widely excluded from randomized device registration trials. The LF study (LEADERS FREE) reported superior outcomes of HBR patients receiving 30-day dual a ... Full text Link to item Cite

Long-Term Safety and Efficacy of Durable Polymer Cobalt-Chromium Everolimus-Eluting Stents in Patients at High Bleeding Risk: A Patient-Level Stratified Analysis From Four Postapproval Studies.

Journal Article Circulation · March 17, 2020 BACKGROUND: Long-term outcomes in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention with a drug-eluting stent are unclear. Therefore, we aimed to evaluate long-term adverse events in HBR patients undergoing percutaneous cor ... Full text Link to item Cite

Defining device success for percutaneous coronary intervention trials: a position statement from the European Association of Percutaneous Cardiovascular Interventions of the European Society of Cardiology.

Journal Article EuroIntervention · January 17, 2020 Percutaneous coronary intervention with implantation of drug-eluting stents has become the most commonly performed revascularisation procedure in patients with symptomatic coronary artery disease. Continuous iterations of coronary devices incorporating cha ... Full text Link to item Cite

Clinical and regulatory landscape for cardiogenic shock: A report from the Cardiac Safety Research Consortium ThinkTank on cardiogenic shock.

Journal Article Am Heart J · January 2020 Full text Link to item Cite

Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention for Acute Coronary Syndrome

Conference CIRCULATION · December 17, 2019 Link to item Cite

Percutaneous coronary intervention outcomes in patients with stable coronary disease and left ventricular systolic dysfunction.

Journal Article ESC Heart Fail · December 2019 AIMS: We sought to better understand the role of percutaneous coronary intervention (PCI) in patients with stable coronary artery disease (CAD) and moderate or severe left ventricular systolic dysfunction. METHODS AND RESULTS: Using data from the Duke Data ... Full text Open Access Link to item Cite

Opportunities for enhancing the care of older patients with ST-elevation myocardial infarction presenting for primary percutaneous coronary intervention: Rationale and design of the SAFE-STEMI for Seniors trial.

Journal Article Am Heart J · December 2019 Advanced age is directly related to worse outcomes following ST-elevation myocardial infarction (STEMI) and higher complication rates from antithrombotic therapies and primary percutaneous coronary intervention (PCI). Often excluded from clinical trials, s ... Full text Link to item Cite

Claims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials.

Journal Article Am Heart J · December 2019 BACKGROUND: Medicare insurance claims may provide an efficient means to ascertain follow-up of older participants in clinical research. We sought to determine the accuracy and completeness of claims- versus site-based follow-up with clinical event committe ... Full text Link to item Cite

Patients' Willingness to Accept Mitral Valve Procedure-Associated Risks Varies Across Severity of Heart Failure Symptoms.

Journal Article Circ Cardiovasc Interv · December 2019 BACKGROUND: The Food and Drug Administration's Center for Drugs and Radiological Health issued Guidance in 2016 on generating patient preference information to aid evaluation of medical devices. Consistent with this guidance, we aimed to provide quantitati ... Full text Link to item Cite

Ticagrelor with or without Aspirin in High-Risk Patients after PCI.

Journal Article N Engl J Med · November 21, 2019 BACKGROUND: Monotherapy with a P2Y12 inhibitor after a minimum period of dual antiplatelet therapy is an emerging approach to reduce the risk of bleeding after percutaneous coronary intervention (PCI). METHODS: In a double-blind trial, we examined the effe ... Full text Link to item Cite

Implanted Monitor Alerting to Reduce Treatment Delay in Patients With Acute Coronary Syndrome Events.

Journal Article J Am Coll Cardiol · October 22, 2019 BACKGROUND: Increased pre-hospital delay during acute coronary syndrome (ACS) events contributes to worse outcome. OBJECTIVES: The purpose of this study was to assess the effectiveness of an implanted cardiac monitor with real-time alarms for abnormal ST-s ... Full text Link to item Cite

Geographical Variations in Patterns of DAPT Cessation and Two-Year PCI Outcomes: Insights from the PARIS Registry.

Journal Article Thromb Haemost · October 2019 BACKGROUND: Data on geographical variations in dual antiplatelet therapy (DAPT) cessation and the impact on outcomes after percutaneous coronary intervention (PCI) are limited. We sought to evaluate geographical patterns of DAPT cessation and associated ou ... Full text Link to item Cite

Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk.

Journal Article Eur Heart J · August 14, 2019 Identification and management of patients at high bleeding risk undergoing percutaneous coronary intervention are of major importance, but a lack of standardization in defining this population limits trial design, data interpretation, and clinical decision ... Full text Link to item Cite

Conversation in cardiology: Is there a need for clinical trials for the nonhyperemic pressure ratios?

Journal Article Catheter Cardiovasc Interv · August 1, 2019 Full text Link to item Cite

Patients Accept Mortality Risk for Improvements in Physical Functioning in Secondary Mitral Regurgitation

Conference Journal of Cardiac Failure · August 2019 Full text Cite

Defining High Bleeding Risk in Patients Undergoing Percutaneous Coronary Intervention.

Journal Article Circulation · July 16, 2019 Identification and management of patients at high bleeding risk undergoing percutaneous coronary intervention are of major importance, but a lack of standardization in defining this population limits trial design, data interpretation, and clinical decision ... Full text Link to item Cite

Incidence, predictors, and outcomes of DAPT disruption due to non-compliance vs. bleeding after PCI: insights from the PARIS Registry.

Journal Article Clin Res Cardiol · June 2019 BACKGROUND: The disruption of dual antiplatelet therapy (DAPT) due to non-compliance or bleeding is known to significantly increase the risk of adverse outcomes after percutaneous coronary intervention (PCI). However, it is currently unknown if there are d ... Full text Link to item Cite

Dual-Antiplatelet Therapy Cessation and Cardiovascular Risk in Relation to Age: Analysis From the PARIS Registry.

Journal Article JACC Cardiovasc Interv · May 27, 2019 OBJECTIVES: The aim of this study was to examine the association between dual-antiplatelet therapy (DAPT) cessation and cardiovascular risk after percutaneous coronary intervention in relation to age. BACKGROUND: Examination of outcomes by age after percut ... Full text Link to item Cite

Association of Preoperative Renin-Angiotensin System Inhibitors With Prevention of Postoperative Atrial Fibrillation and Adverse Events: A Systematic Review and Meta-analysis.

Journal Article JAMA Netw Open · May 3, 2019 IMPORTANCE: Postoperative atrial fibrillation (POAF) is a well-known complication after cardiac surgery. Renin-angiotensin system inhibitors (RASIs) have been suggested as an upstream therapy for selected patients with AF; however, evidence in the surgical ... Full text Link to item Cite

Comparison of Rates of Bleeding and Vascular Complications Before, During, and After Trial Enrollment in the SAFE-PCI Trial for Women.

Journal Article Circ Cardiovasc Interv · May 2019 BACKGROUND: SAFE-PCI for Women (Study of Access Site for Enhancement of PCI for Women), a randomized controlled trial comparing radial and femoral access in women undergoing cardiac catheterization or percutaneous coronary intervention (PCI), was terminate ... Full text Link to item Cite

Implantable Cardiac Alert System for Early Recognition of ST-Segment Elevation Myocardial Infarction.

Journal Article J Am Coll Cardiol · April 23, 2019 Featured Publication BACKGROUND: Symptoms remain a poor prompt for acute coronary syndromes (ACS). Timely restoration of perfusion in ST-segment elevation myocardial infarction is associated with improved left ventricular function and survival. OBJECTIVES: This report details ... Full text Link to item Cite

Age, STEMI, and Cardiogenic Shock: Never Too Old for PCI?

Journal Article J Am Coll Cardiol · April 23, 2019 Full text Link to item Cite

Influence of Baseline Anemia on Dual Antiplatelet Therapy Cessation and Risk of Adverse Events After Percutaneous Coronary Intervention.

Journal Article Circ Cardiovasc Interv · April 2019 BACKGROUND: Anemia is a well-recognized risk factor for both bleeding and ischemic events after percutaneous coronary intervention (PCI). We sought to determine the impact of baseline anemia on dual antiplatelet therapy (DAPT) cessation patterns ≤2 years a ... Full text Link to item Cite

Patterns and Impact of Dual Antiplatelet Cessation on Cardiovascular Risk After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndromes.

Journal Article Am J Cardiol · March 1, 2019 The aim of this study was to examine the patterns and clinical impact of differing modes of dual-antiplatelet therapy (DAPT) cessation after percutaneous coronary intervention (PCI) in patients presenting with and without acute coronary syndromes (ACS). Th ... Full text Link to item Cite

Tailoring Antiplatelet Therapy Intensity to Ischemic and Bleeding Risk.

Journal Article Circ Cardiovasc Qual Outcomes · January 2019 BACKGROUND: Balancing ischemic and bleeding risk is an evolving framework. METHODS AND RESULTS: Our objectives were to simulate changes in risks for adverse events and event-driven costs with use of ticagrelor or prasugrel versus clopidogrel according to v ... Full text Link to item Cite

Determining value of Coordinated Registry Networks (CRNs): a case of transcatheter valve therapies.

Journal Article BMJ Surg Interv Health Technol · 2019 BACKGROUND: The Transcatheter Valve Therapy (TVT) Coordinated Registry Network (CRN) supported 23 regulatory decisions and ensured evidence-based evaluation of the application of TVT technology. However, there are cost concerns that require value assessmen ... Full text Link to item Cite

The Impact of a Rigorous Quality Program on 3D Echocardiography Data Quality in an International Multisite Randomized Trial.

Conference JACC Cardiovasc Imaging · December 2018 Full text Link to item Cite

The East-West late lumen loss study: Comparison of angiographic late lumen loss between Eastern and Western drug-eluting stent study cohorts.

Journal Article Am Heart J · December 2018 BACKGROUND: Regulatory decisions approving new coronary drug-eluting stent (DES) require mechanistic observations of angiographic late lumen loss (LLL). Patient safety and device approval times could be enhanced if angiographic follow-up data were found to ... Full text Link to item Cite

Bursts of reperfusion arrhythmias occur independently of area at risk size and are the first marker of reperfusion injury.

Journal Article Int J Cardiol · November 15, 2018 BACKGROUND: The presence of reperfusion ventricular arrhythmias (VA) has been shown to correlate with larger infarct size (IS). However it is unclear whether the initial area at risk (AAR), also a determining factor for IS, is responsible for this correlat ... Full text Link to item Cite

Dual Antiplatelet Therapy Cessation and Adverse Events After Drug-Eluting Stent Implantation in Patients at High Risk for Atherothrombosis (from the PARIS Registry).

Journal Article Am J Cardiol · November 15, 2018 The impact of dual antiplatelet therapy (DAPT) cessation after percutaneous coronary intervention with drug eluting stent implantation in patients at high atherothrombotic risk remains unclear. We aimed to characterize the risk for adverse events, and its ... Full text Link to item Cite

Performance Goal Criteria for Device Evaluation in Lower Extremity Peripheral Vascular Intervention and the Need for Standardized Data Structure: What Is the Sound of One Hand Clapping?

Journal Article JACC Cardiovasc Interv · October 8, 2018 Full text Link to item Cite

A Path Forward for Regenerative Medicine.

Journal Article Circ Res · August 3, 2018 Although clinical trials of cell-based approaches to cardiovascular disease have yielded some promising results, no cell-based therapy has achieved regulatory approval for a cardiovascular indication. To broadly assess the challenges to regulatory approval ... Full text Link to item Cite

The Second Annual Think Tank on Prevention of Sudden Cardiac Death in the Young: Developing a rational, reliable, and sustainable national health care resource. A report from the Cardiac Safety Research Consortium.

Journal Article Am Heart J · August 2018 Sudden cardiac death in the young (SCDY) spans gender, race, ethnicity, and socioeconomic class. The loss of any pediatric patient is a matter of national and international public health concern, and focused efforts should be aimed at preventing these burd ... Full text Link to item Cite

Japan-United States of America Harmonized Assessment by Randomized Multicentre Study of OrbusNEich's Combo StEnt (Japan-USA HARMONEE) study: primary results of the pivotal registration study of combined endothelial progenitor cell capture and drug-eluting stent in patients with ischaemic coronary disease and non-ST-elevation acute coronary syndrome.

Journal Article Eur Heart J · July 7, 2018 AIMS: Harmonized Assessment by Randomized Multicentre Study of OrbusNEich's Combo StEnt (HARMONEE) (NCT02073565) was a randomized pivotal registration trial of the Combo stent, which combined sirolimus and an abluminal bioabsorbable polymer with a novel en ... Full text Link to item Cite

Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document.

Journal Article Eur Heart J · June 14, 2018 The Academic Research Consortium (ARC)-2 initiative revisited the clinical and angiographic end point definitions in coronary device trials, proposed in 2007, to make them more suitable for use in clinical trials that include increasingly complex lesion an ... Full text Link to item Cite

Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document.

Journal Article Circulation · June 12, 2018 The Academic Research Consortium (ARC)-2 initiative revisited the clinical and angiographic end point definitions in coronary device trials, proposed in 2007, to make them more suitable for use in clinical trials that include increasingly complex lesion an ... Full text Link to item Cite

Drug-eluting stents versus bare-metal stents in saphenous vein grafts: a double-blind, randomised trial.

Journal Article Lancet · May 19, 2018 BACKGROUND: Few studies have examined the efficacy of drug-eluting stents (DES) for reducing aortocoronary saphenous vein bypass graft (SVG) failure compared with bare-metal stents (BMS) in patients undergoing stenting of de-novo SVG lesions. We assessed t ... Full text Link to item Cite

Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative.

Journal Article Eur Heart J · May 14, 2018 Surgical and catheter-based cardiovascular procedures and adjunctive pharmacology have an inherent risk of neurological complications. The current diversity of neurological endpoint definitions and ascertainment methods in clinical trials has led to uncert ... Full text Link to item Cite

Reperfusion ventricular arrhythmia bursts identify larger infarct size in spite of optimal epicardial and microvascular reperfusion using cardiac magnetic resonance imaging.

Journal Article Eur Heart J Acute Cardiovasc Care · April 2018 AIMS: Ventricular arrhythmia (VA) bursts following recanalisation in acute ST-elevation myocardial infarction (STEMI) are related to larger infarct size (IS). Inadequate microvascular reperfusion, as determined by microvascular obstruction (MVO) using card ... Full text Link to item Cite

Incidence, Patterns, and Impact of Dual Antiplatelet Therapy Cessation Among Patients With and Without Chronic Kidney Disease Undergoing Percutaneous Coronary Intervention: Results From the PARIS Registry (Patterns of Non-Adherence to Anti-Platelet Regimens in Stented Patients).

Journal Article Circ Cardiovasc Interv · March 2018 BACKGROUND: Patients with chronic kidney disease (CKD) experience high rates of ischemic and bleeding events after percutaneous coronary intervention (PCI), complicating decisions surrounding dual antiplatelet therapy (DAPT). This study aims to determine t ... Full text Link to item Cite

Registry Assessment of Peripheral Interventional Devices (RAPID): Registry assessment of peripheral interventional devices core data elements.

Journal Article J Vasc Surg · February 2018 OBJECTIVE: The current state of evaluating patients with peripheral artery disease and more specifically of evaluating medical devices used for peripheral vascular intervention (PVI) remains challenging because of the heterogeneity of the disease process, ... Full text Link to item Cite

Registry Assessment of Peripheral Interventional Devices (RAPID)　- Registry Assessment of Peripheral Interventional Devices Core Data Elements.

Journal Article Circ J · January 25, 2018 BACKGROUND: The current state of evaluating patients with peripheral artery disease and more specifically of evaluating medical devices used for peripheral vascular intervention (PVI) remains challenging because of the heterogeneity of the disease process, ... Full text Link to item Cite

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

Journal Article The Journal of invasive cardiology · January 2018 ObjectivesThis study was conducted to determine the association between radial access, guided femoral access, and non-guided femoral access on postprocedural bleeding and vascular complications after percutaneous coronary intervention (PCI).Ba ... Cite

Advancing medical device innovation through collaboration and coordination of structured data capture pilots: Report from the Medical Device Epidemiology Network (MDEpiNet) Specific, Measurable, Achievable, Results-Oriented, Time Bound (SMART) Think Tank.

Journal Article Healthc (Amst) · December 2017 The Medical Device Epidemiology Network (MDEpiNet) is a public private partnership (PPP) that provides a platform for collaboration on medical device evaluation and depth of expertise for supporting pilots to capture, exchange and use device information fo ... Full text Link to item Cite

Understanding operator stent choice in the catheterization laboratory using a pre-procedure survey: Opportunities for quality improvement.

Journal Article Cardiovasc Revasc Med · December 2017 OBJECTIVES: We sought to characterize how the perceived risk of early dual antiplatelet therapy (DAPT) discontinuation is incorporated into operator decision-making regarding stent choice, using a simple pre-procedure survey screening for clinical variable ... Full text Open Access Link to item Cite

Enabling social listening for cardiac safety monitoring: Proceedings from a drug information association-cardiac safety research consortium cosponsored think tank.

Journal Article Am Heart J · December 2017 This white paper provides a summary of the presentations and discussions from a think tank on "Enabling Social Listening for Cardiac Safety Monitoring" trials that was cosponsored by the Drug Information Association and the Cardiac Safety Research Consorti ... Full text Link to item Cite

White Blood Cell Count and Major Adverse Cardiovascular Events After Percutaneous Coronary Intervention in the Contemporary Era: Insights From the PARIS Study (Patterns of Non-Adherence to Anti-Platelet Regimens in Stented Patients Registry).

Journal Article Circ Cardiovasc Interv · September 2017 BACKGROUND: Elevated white blood cell (WBC) count is associated with increased major adverse cardiovascular events (MACE) in the setting of acute coronary syndrome. The aim of this study was to evaluate whether similar associations persist in an all-comers ... Full text Link to item Cite

Prevention of sudden cardiac death in the young: Developing a rational, reliable, and sustainable national health care resource. A report from the Cardiac Safety Research Consortium.

Journal Article Am Heart J · August 2017 This White Paper, prepared by members of the Cardiac Safety Research Consortium, discusses important issues regarding sudden cardiac death in the young (SCDY), a problem that does not discriminate by gender, race, ethnicity, education, socioeconomic level, ... Full text Link to item Cite

Cardiovascular events and hospital resource utilization pre- and post-transcatheter mitral valve repair in high-surgical risk patients.

Journal Article Am Heart J · July 2017 UNLABELLED: MitraClip is an approved therapy for mitral regurgitation (MR); however, health care resource utilization pre- and post-MitraClip remains understudied. METHODS: Patients with functional and degenerative MR at high surgical risk in the EVEREST I ... Full text Link to item Cite

Rationale and design of the Japan-USA harmonized assessment by randomized, multicenter study of OrbusNEich's combo StEnt (Japan-USA HARMONEE): Assessment of a novel DES platform for percutaneous coronary revascularization in patients with ischemic coronary disease and non-ST-elevation acute coronary syndrome.

Journal Article Am Heart J · May 2017 Tissue trauma associated with stent implantation continues to generate early thrombosis rates of 0.9% to 1.3% for both bare-metal and drug-eluting stent platforms. The Combo sirolimus-eluting stent combines an abluminal, bioabsorbable polymer with a lumina ... Full text Link to item Cite

Incidence, Patterns, and Associations Between Dual-Antiplatelet Therapy Cessation and Risk for Adverse Events Among Patients With and Without Diabetes Mellitus Receiving Drug-Eluting Stents: Results From the PARIS Registry.

Journal Article JACC Cardiovasc Interv · April 10, 2017 OBJECTIVES: The aim of this study was to examine the frequency and clinical impact of different cessation patterns of dual-antiplatelet therapy (DAPT) after percutaneous coronary intervention with drug-eluting stents among patients with and those without d ... Full text Link to item Cite

ST-elevation no myocardial infarction.

Journal Article J Thromb Thrombolysis · April 2017 Full text Link to item Cite

Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative.

Journal Article J Am Coll Cardiol · February 14, 2017 Surgical and catheter-based cardiovascular procedures and adjunctive pharmacology have an inherent risk of neurological complications. The current diversity of neurological endpoint definitions and ascertainment methods in clinical trials has led to uncert ... Full text Link to item Cite

Editorial: Radial to Coronary: Ideal Catheter for the Ideal Approach.

Journal Article J Interv Cardiol · February 2017 Full text Link to item Cite

What is the best ST-segment recovery parameter to predict clinical outcome and myocardial infarct size? Amplitude, speed, and completeness of ST-segment recovery after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction.

Journal Article J Electrocardiol · 2017 AIMS: ST-segment recovery (STR) is a strong mechanistic correlate of infarct size (IS) and outcome in ST-segment elevation myocardial infarction (STEMI). Characterizing measures of speed, amplitude, and completeness of STR may extend the use of this noninv ... Full text Link to item Cite

Rationale and design of the East-West late lumen loss study: Comparison of late lumen loss between Eastern and Western drug-eluting stent study cohorts.

Journal Article Am Heart J · December 2016 BACKGROUND: The contemporary evaluation of novel drug-eluting stents (DES) includes mechanistic observations that characterize postdeployment stent behavior. Quantification of late lumen loss due to neointimal hyperplasia 8-13 months after stent implantati ... Full text Link to item Cite

Ticagrelor with aspirin or alone in high-risk patients after coronary intervention: Rationale and design of the TWILIGHT study.

Journal Article Am Heart J · December 2016 BACKGROUND: Dual antiplatelet therapy (DAPT) is necessary to prevent thrombosis yet increases bleeding after percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Antiplatelet monotherapy with a potent P2Y12 receptor antagonist may reduc ... Full text Link to item Cite

Coronary Artery Complication in Kawasaki Disease and the Importance of Early Intervention : A Systematic Review and Meta-analysis.

Journal Article JAMA Pediatr · December 1, 2016 IMPORTANCE: The timing and selection of patients with Kawasaki disease for corticosteroid use to prevent coronary artery complications remain controversial. OBJECTIVE: To evaluate the effect of corticosteroid therapy in KD. DATA SOURCES: Databases of Medli ... Full text Link to item Cite

The Changing Landscape of Randomized Clinical Trials in Cardiovascular Disease.

Journal Article J Am Coll Cardiol · October 25, 2016 Large randomized clinical trials in cardiovascular disease have proliferated over the past 3 decades, with results that have influenced every aspect of cardiology practice. Despite these advances, there remains a substantial need for more high-quality evid ... Full text Link to item Cite

Bioabsorbable Intracoronary Matrix for Prevention of Ventricular Remodeling After Myocardial Infarction.

Journal Article J Am Coll Cardiol · August 16, 2016 BACKGROUND: Bioabsorbable cardiac matrix (BCM) is a novel device that attenuates adverse left ventricular (LV) remodeling after large myocardial infarctions in experimental models. OBJECTIVES: This study aimed to analyze whether BCM, compared with saline c ... Full text Link to item Cite

Cardiac pacing strategies and post-implantation risk of atrial fibrillation and heart failure events in sinus node dysfunction patients: a collaborative analysis of over 6000 patients.

Journal Article Clin Res Cardiol · August 2016 BACKGROUND: Pacing-modes selection in sinus-node-dysfunction (SND) patients continues to be a subject of debate. Atrial fibrillation (AF) and cardiac dysfunction remain significant problems following cardiac-pacing therapy. Prevention of these complication ... Full text Link to item Cite

Radial Versus Femoral Access for Coronary Interventions Across the Entire Spectrum of Patients With Coronary Artery Disease: A Meta-Analysis of Randomized Trials.

Journal Article JACC Cardiovasc Interv · July 25, 2016 OBJECTIVES: The aim of this study was to provide a quantitative appraisal of the effects on clinical outcomes of radial access for coronary interventions in patients with coronary artery disease (CAD). BACKGROUND: Randomized trials investigating radial ver ... Full text Link to item Cite

Sex-Based Differences in Cessation of Dual-Antiplatelet Therapy Following Percutaneous Coronary Intervention With Stents.

Journal Article JACC Cardiovasc Interv · July 25, 2016 OBJECTIVES: The aim of this study was to compare the incidence and impact of cessation of dual-antiplatelet therapy (DAPT) in women and men treated with percutaneous coronary intervention. BACKGROUND: Nonadherence to cardiovascular medications and female s ... Full text Link to item Cite

Economic Outcomes With Anatomical Versus Functional Diagnostic Testing for Coronary Artery Disease.

Journal Article Ann Intern Med · July 19, 2016 BACKGROUND: PROMISE (PROspective Multicenter Imaging Study for Evaluation of Chest Pain) found that initial use of at least 64-slice multidetector computed tomography angiography (CTA) versus functional diagnostic testing strategies did not improve clinica ... Full text Open Access Link to item Cite

Time-Dependent Associations Between Actionable Bleeding, Coronary Thrombotic Events, and Mortality Following Percutaneous Coronary Intervention: Results From the PARIS Registry.

Journal Article JACC Cardiovasc Interv · July 11, 2016 OBJECTIVES: The aim of this study was to examine the independent associations between actionable bleeding (AB) and coronary thrombotic events (CTE) on mortality risk after percutaneous coronary intervention (PCI). BACKGROUND: The independent impact of AB a ... Full text Link to item Cite

Clinical outcomes in real-world patients with bifurcation lesions receiving Xience V everolimus-eluting stents: Four-year results from the Xience V USA study.

Journal Article Catheter Cardiovasc Interv · July 2016 BACKGROUND: The Xience V USA Study demonstrated safety and efficacy of the XIENCE V(®) everolimus-eluting stent (EES) in a large, prospective study of a real-world, unselected patient population. There is limited long-term data regarding EES performance in ... Full text Link to item Cite

The Cardiac Safety Research Consortium enters its second decade: An invitation to participate.

Journal Article Am Heart J · July 2016 The Cardiac Safety Research Consortium (CSRC), a transparent, public-private partnership established in 2005 as a Critical Path Program and formalized in 2006 under a Memorandum of Understanding between the United States Food and Drug Administration and Du ... Full text Link to item Cite

Coronary Thrombosis and Major Bleeding After PCI With Drug-Eluting Stents: Risk Scores From PARIS.

Journal Article J Am Coll Cardiol · May 17, 2016 BACKGROUND: Dual-antiplatelet therapy with aspirin and clopidogrel after percutaneous coronary intervention reduces the risk for coronary thrombotic events (CTEs) at the expense of increasing risk for major bleeding (MB). Metrics to accurately predict the ... Full text Link to item Cite

Maximum likelihood estimation of time to first event in the presence of data gaps and multiple events.

Journal Article Stat Methods Med Res · April 2016 We propose a novel likelihood method for analyzing time-to-event data when multiple events and multiple missing data intervals are possible prior to the first observed event for a given subject. This research is motivated by data obtained from a heart moni ... Full text Link to item Cite

Benefits and Risks of Extended Dual Antiplatelet Therapy After Everolimus-Eluting Stents.

Journal Article JACC Cardiovasc Interv · January 25, 2016 OBJECTIVES: The purpose of this study was to characterize outcomes for everolimus-eluting stent (EES)-treated subjects according to treatment with continued thienopyridine plus aspirin versus aspirin alone 12 to 30 months after stenting. BACKGROUND: In the ... Full text Link to item Cite

Predictable and SuStainable Implementation of National Cardiovascular Registries (PASSION) infrastructure: A think tank report from Medical Device Epidemiological Network Initiative (MDEpiNet).

Journal Article Am Heart J · January 2016 The MDEpiNet is a public-private partnership between the US Food and Drug Administration's Center for Devices and Radiological Health and participating partners. The PASSION program is an MDEpiNet-sponsored program that aims to demonstrate the goals of MDE ... Full text Link to item Cite

Ventricular arrhythmia burst is an independent indicator of larger infarct size even in optimal reperfusion in STEMI.

Journal Article J Electrocardiol · 2016 OBJECTIVE: We hypothesized that ventricular arrhythmia (VA) bursts during reperfusion phase are a marker of larger infarct size despite optimal epicardial and microvascular perfusion. METHODS: 126 STEMI patients were studied with 24h continuous, 12-lead Ho ... Full text Link to item Cite

Embedding clinical interventions into observational studies.

Journal Article Contemp Clin Trials · January 2016 Novel approaches to observational studies and clinical trials could improve the cost-effectiveness and speed of translation of research. Hybrid designs that combine elements of clinical trials with observational registries or cohort studies should be consi ... Full text Link to item Cite

The MitraClip and survival in patients with mitral regurgitation at high risk for surgery: A propensity-matched comparison.

Journal Article Am Heart J · November 2015 BACKGROUND: We compared 30-day and 1-year survival among high-risk mitral regurgitation (MR) patients treated with the MitraClip (Abbott Vascular, Abbott Park, IL) with matched non-surgically treated patients from the Duke Echocardiography Laboratory Datab ... Full text Link to item Cite

A randomized, double-blind, placebo-controlled trial to evaluate the safety and effectiveness of intracoronary application of a novel bioabsorbable cardiac matrix for the prevention of ventricular remodeling after large ST-segment elevation myocardial infarction: Rationale and design of the PRESERVATION I trial.

Journal Article Am Heart J · November 2015 Postinfarction left ventricular (LV) remodeling can result in chronic heart failure and functional impairment. Although pharmacological strategies for established heart failure can be beneficial, preventing remodeling remains a challenge. Injectable bioabs ... Full text Link to item Cite

Bridging Unmet Medical Device Ecosystem Needs With Strategically Coordinated Registries Networks.

Journal Article JAMA · October 27, 2015 Full text Link to item Cite

Prospective evaluation of where reperfusion ventricular arrhythmia "bursts" fit into optimal reperfusion in STEMI.

Journal Article Int J Cardiol · September 15, 2015 BACKGROUND: Early reperfusion of ischemic myocytes is essential for optimal salvage in acute myocardial infarction. VA (ventricular arrhythmia) bursts after recanalization of the culprit vessel have been found to be related to larger infarct size (IS), usi ... Full text Link to item Cite

Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: part 1: clinical trial design principles: A consensus document from the mitral valve academic research consortium.

Journal Article Eur Heart J · August 1, 2015 Mitral regurgitation (MR) is one of the most prevalent valve disorders and has numerous aetiologies, including primary (organic) MR, due to underlying degenerative/structural mitral valve (MV) pathology, and secondary (functional) MR, which is principally ... Full text Link to item Cite

Comparison of quality-of-life measures after radial versus femoral artery access for cardiac catheterization in women: Results of the Study of Access Site for Enhancement of Percutaneous Coronary Intervention for Women quality-of-life substudy.

Journal Article Am Heart J · August 2015 BACKGROUND: In the SAFE-PCI for Women trial, patient preference for radial access for future procedures was greater than for femoral access. We sought to assess whether radial or femoral access impacts formal measures of quality-of-life (QOL) among women u ... Full text Link to item Cite

Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 1: Clinical Trial Design Principles: A Consensus Document From the Mitral Valve Academic Research Consortium.

Journal Article J Am Coll Cardiol · July 21, 2015 Mitral regurgitation (MR) is one of the most prevalent valve disorders and has numerous etiologies, including primary (organic) MR, due to underlying degenerative/structural mitral valve (MV) pathology, and secondary (functional) MR, which is principally c ... Full text Link to item Cite

Relationship Between Cancer and Cardiovascular Outcomes Following Percutaneous Coronary Intervention.

Journal Article J Am Heart Assoc · July 6, 2015 BACKGROUND: Cardiovascular disease and cancer increasingly coexist, yet relationships between cancer and long-term cardiovascular outcomes post-percutaneous coronary intervention (PCI) are not well studied. METHODS AND RESULTS: We examined stented PCI pati ... Full text Open Access Link to item Cite

Cardiac Safety Research Consortium (CSRC): Cardiovascular Safety and Adverse Event Case Report Forms.

Journal Article Ther Innov Regul Sci · July 2015 Detection of off-target cardiovascular (CV) effects remains a significant challenge to drug development. Documentation of CV events in non-CV trials is often inadequate to interpret imbalances between treatment arms, which may lead to concerns about potent ... Full text Link to item Cite

Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes.

Journal Article N Engl J Med · June 18, 2015 BACKGROUND: Statin therapy reduces low-density lipoprotein (LDL) cholesterol levels and the risk of cardiovascular events, but whether the addition of ezetimibe, a nonstatin drug that reduces intestinal cholesterol absorption, can reduce the rate of cardio ... Full text Link to item Cite

Erratum: Evaluation and treatment of patients with lower extremity peripheral artery disease: Consensus definitions from Peripheral Academic Research Consortium (PARC) (Journal of the American College of Cardiology (2015) 65:(931-41))

Journal Article Journal of the American College of Cardiology · June 16, 2015 Full text Cite

Novel oral anticoagulants and reversal agents: Considerations for clinical development.

Other Am Heart J · June 2015 This white paper provides a summary of presentations and discussions that were held at an Anticoagulant-Induced Bleeding and Reversal Agents Think Tank co-sponsored by the Cardiac Safety Research Consortium and the US Food and Drug Administration (FDA) at ... Full text Link to item Cite

Stent Thrombosis and Dual Antiplatelet Therapy Interruption With Everolimus-Eluting Stents: Insights From the Xience V Coronary Stent System Trials.

Journal Article Circ Cardiovasc Interv · May 2015 BACKGROUND: Whether premature dual antiplatelet therapy (DAPT) interruption is safe in patients receiving cobalt chromium everolimus-eluting stents remains controversial. We sought to examine the relationship between DAPT discontinuation and stent thrombos ... Full text Link to item Cite

Reply: Transradial PCI in Women: Zeroing in on Crossovers.

Journal Article JACC Cardiovasc Interv · April 20, 2015 Full text Link to item Cite

Outcomes of anatomical versus functional testing for coronary artery disease.

Journal Article N Engl J Med · April 2, 2015 BACKGROUND: Many patients have symptoms suggestive of coronary artery disease (CAD) and are often evaluated with the use of diagnostic testing, although there are limited data from randomized trials to guide care. METHODS: We randomly assigned 10,003 sympt ... Full text Link to item Cite

Evaluation and treatment of patients with lower extremity peripheral artery disease: consensus definitions from Peripheral Academic Research Consortium (PARC).

Journal Article J Am Coll Cardiol · March 10, 2015 The lack of consistent definitions and nomenclature across clinical trials of novel devices, drugs, or biologics poses a significant barrier to accrual of knowledge in and across peripheral artery disease therapies and technologies. Recognizing this proble ... Full text Link to item Cite

Response to letter regarding article, "The learning curve for transradial percutaneous coronary intervention among operators in the United States: a study from the National Cardiovascular Data Registry".

Journal Article Circulation · February 24, 2015 Full text Link to item Cite

Implications of ventricular arrhythmia "bursts" with normal epicardial flow, myocardial blush, and ST-segment recovery in anterior ST-elevation myocardial infarction reperfusion: a biosignature of direct myocellular injury "downstream of downstream".

Journal Article Eur Heart J Acute Cardiovasc Care · February 2015 AIMS: Establishing epicardial flow with percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) is necessary but not sufficient to ensure nutritive myocardial reperfusion. We evaluated whether adding myocardial blush ... Full text Link to item Cite

Cardiac troponin I for prediction of clinical outcomes and cardiac function through 3-month follow-up after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction.

Conference Am Heart J · February 2015 BACKGROUND: Circulating levels of cardiac troponin I (cTnI) after ST-segment elevation myocardial infarction (STEMI) are associated with infarct size and chronic left ventricular dysfunction, but the relation to clinical end points and biochemical measures ... Full text Link to item Cite

Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents.

Journal Article N Engl J Med · December 4, 2014 BACKGROUND: Dual antiplatelet therapy is recommended after coronary stenting to prevent thrombotic complications, yet the benefits and risks of treatment beyond 1 year are uncertain. METHODS: Patients were enrolled after they had undergone a coronary stent ... Full text Link to item Cite

Risk and Benefit of Prolonged Dual Antiplatelet Therapy After Drug-eluting Coronary Stents: Primary Endpoint Results from the Dual Antiplatelet Therapy Study

Conference CIRCULATION · December 2, 2014 Link to item Cite

Generalizability of Quantitative Angiographic In-Segment Late Lumen Loss Imaging in Eastern and Western Populations: Can We Facilitate Global Drug Eluting Stent Evaluation?

Conference CIRCULATION · November 25, 2014 Link to item Cite

Outcomes After Percutaneous Coronary Intervention for Patients With Stable Coronary Disease and Left Ventricular Systolic Dysfunction

Conference CIRCULATION · November 25, 2014 Link to item Cite

Design and rationale of the ANALYZE ST study: a prospective, nonrandomized, multicenter ST monitoring study to detect acute coronary syndrome events in implantable cardioverter-defibrillator patients.

Journal Article Am Heart J · October 2014 BACKGROUND: In the setting of ST-segment elevation myocardial infarction, timely restoration of normal blood flow is associated with improved myocardial salvage and survival. Despite improvements in door-to-needle and door-to-balloon times, there remains a ... Full text Link to item Cite

Inhibition of delta-protein kinase C by delcasertib as an adjunct to primary percutaneous coronary intervention for acute anterior ST-segment elevation myocardial infarction: results of the PROTECTION AMI Randomized Controlled Trial.

Journal Article Eur Heart J · October 1, 2014 AIMS: Delcasertib is a selective inhibitor of delta-protein kinase C (delta-PKC), which reduced infarct size during ischaemia/reperfusion in animal models and diminished myocardial necrosis and improved reperfusion in a pilot study during primary percutane ... Full text Link to item Cite

Clinical outcomes in the percutaneous coronary intervention of in-stent restenosis with everolimus-eluting stents.

Journal Article J Invasive Cardiol · September 2014 BACKGROUND: Although percutaneous coronary intervention with everolimus-eluting stent (EES) implantation for native coronary artery disease has favorable results compared to first-generation drug-eluting stents, outcomes with EES for the treatment of in-st ... Link to item Cite

Rationale and design of the AngeLmed for Early Recognition and Treatment of STEMI trial: a randomized, prospective clinical investigation.

Journal Article Am Heart J · August 2014 Significant improvements in door-to-balloon times have led to a reduction in mortality in ST-segment elevation myocardial infarction; however, mean symptom-to-door times remain at 2 to 3 hours. An intracardiac electrogram monitoring device may be beneficia ... Full text Link to item Cite

A registry-based randomized trial comparing radial and femoral approaches in women undergoing percutaneous coronary intervention: the SAFE-PCI for Women (Study of Access Site for Enhancement of PCI for Women) trial.

Journal Article JACC Cardiovasc Interv · August 2014 OBJECTIVES: This study sought to determine the effect of radial access on outcomes in women undergoing percutaneous coronary intervention (PCI) using a registry-based randomized trial. BACKGROUND: Women are at increased risk of bleeding and vascular compli ... Full text Link to item Cite

Clinical outcomes in real-world patients with small vessel disease treated with XIENCE V® everolimus-eluting stents: one year results from the XIENCE V® USA condition of approval post-market study.

Journal Article Catheter Cardiovasc Interv · July 1, 2014 OBJECTIVES: The purpose of this study was to evaluate the 1-year clinical outcomes of more complex XIENCE V USA real-world patients with small versus nonsmall vessel lesions. BACKGROUND: Patients with small vessel lesions undergoing coronary stent placemen ... Full text Link to item Cite

The learning curve for transradial percutaneous coronary intervention among operators in the United States: a study from the National Cardiovascular Data Registry.

Journal Article Circulation · June 3, 2014 BACKGROUND: Adoption of transradial percutaneous coronary intervention (TRI) in the United States is low and may be related to challenges learning the technique. We examined the relationships between operator TRI volume and procedural metrics and outcomes. ... Full text Link to item Cite

PROspective Multicenter Imaging Study for Evaluation of chest pain: rationale and design of the PROMISE trial.

Journal Article Am Heart J · June 2014 BACKGROUND: Suspected coronary artery disease (CAD) is one of the most common, potentially life-threatening diagnostic problems clinicians encounter. However, no large outcome-based randomized trials have been performed to guide the selection of diagnostic ... Full text Link to item Cite

"Take your pill": the role and fantasy of pills in modern medicine.

Journal Article J Altern Complement Med · June 2014 The pharmaceutical industry has undergone a vast expansion in the 20th and 21st centuries. This article explores the central role now played by pills in clinical practice, but also in the public imagination. First, this article analyzes four properties tha ... Full text Link to item Cite

A reevaluation of the costs of heart failure and its implications for allocation of health resources in the United States.

Journal Article Clinical cardiology · May 2014 The annual cost of heart failure (HF) is estimated at $39.2 billion. This has been acknowledged to underestimate the true costs for care. The objective of this analysis is to more accurately assess these costs. Publicly available data sources were used. Co ... Full text Cite

Conversations in cardiology: bridging antiplatelet therapy before surgery.

Journal Article Catheter Cardiovasc Interv · April 1, 2014 Bridging for antiplatelet therapy remains a subject of debate with data favoring GP blockers but at a risk of bleeding. This Conversation in Cardiology addresses a key and often asked question about use of alternatives to P2Y12 agents in patients requiring ... Full text Link to item Cite

Short and long term effect of adjunctive intra-aortic balloon pump use for patients undergoing high risk reperfusion therapy: a meta-analysis of 10 international randomised trials.

Journal Article Heart · February 2014 OBJECTIVE: Current literature shows there is widespread controversy regarding the indications and outcomes of using an intra-aortic balloon pump (IABP); furthermore, little is known about the late effects of IABP use. DESIGN: To determine whether IABP use ... Full text Link to item Cite

Best practices for transradial angiography and intervention: a consensus statement from the society for cardiovascular angiography and intervention's transradial working group.

Journal Article Catheter Cardiovasc Interv · February 2014 Full text Link to item Cite

Cessation of dual antiplatelet treatment and cardiac events after percutaneous coronary intervention (PARIS): 2 year results from a prospective observational study.

Journal Article Lancet · November 23, 2013 BACKGROUND: Dual antiplatelet therapy (DAPT) cessation increases the risk of adverse events after percutaneous coronary intervention (PCI). Whether risk changes over time, depends on the underlying reason for DAPT cessation, or both is unknown. We assessed ... Full text Link to item Cite

Electrocardiographic safety of cangrelor, a new intravenous antiplatelet agent: a randomized, double-blind, placebo- and moxifloxacin-controlled thorough QT study.

Journal Article J Cardiovasc Pharmacol · November 2013 Cangrelor is an intravenous P2Y12 inhibitor under investigation as an antiplatelet drug in the setting of acute coronary syndromes. To determine the electrophysiologic safety of parenteral cangrelor, cardiac repolarization effects were measured in 67 healt ... Full text Link to item Cite

Clinical outcomes in real-world patients with acute myocardial infarction receiving XIENCE V® everolimus-eluting stents: one-year results from the XIENCE V USA study.

Journal Article Catheter Cardiovasc Interv · October 1, 2013 OBJECTIVES: The objective of this analysis was to evaluate the safety and effectiveness of XIENCE V in acute myocardial infarction (AMI). BACKGROUND: The XIENCE V(®) Everolimus-eluting coronary stent was superior to the TAXUS(®) paclitaxel-eluting stent in ... Full text Link to item Cite

Embedding a randomized clinical trial into an ongoing registry infrastructure: unique opportunities for efficiency in design of the Study of Access site For Enhancement of Percutaneous Coronary Intervention for Women (SAFE-PCI for Women).

Journal Article Am Heart J · September 2013 Women are at higher risk than men for bleeding and vascular complications after percutaneous coronary intervention (PCI). Compared with femoral access, radial access reduces these complications but may be more challenging in women because of higher rates o ... Full text Link to item Cite

Conversation in cardiology: should FFR and IVUS be counted as PCI?

Journal Article Catheter Cardiovasc Interv · July 1, 2013 Full text Link to item Cite

The efficacy and safety of cardiac resynchronization therapy combined with implantable cardioverter defibrillator for heart failure: a meta-analysis of 5674 patients.

Journal Article Europace · July 2013 AIMS: The purpose of this study was to evaluate the efficacy and safety of cardiac resynchronization plus implantable cardioverter defibrillator (CRT-D) therapy and implantable cardioverter defibrillator (ICD) therapy in treating heart failure by systemati ... Full text Link to item Cite

Radial first: paradox+proficiency=opportunity.

Journal Article J Am Heart Assoc · June 7, 2013 Full text Link to item Cite

Paced QRS duration as a predictor for clinical heart failure events during right ventricular apical pacing in patients with idiopathic complete atrioventricular block: results from an observational cohort study (PREDICT-HF).

Journal Article Eur J Heart Fail · March 2013 AIMS: The aim of this study was to investigate the predictive ability of paced QRS duration (pQRSd) for heart failure events among patients receiving right ventricular apical pacing (RVAP). METHODS AND RESULTS: A total of 194 patients with complete atriove ... Full text Link to item Cite

TransRadial Education and Therapeutics (TREAT): shifting the balance of safety and efficacy of antithrombotic agents in percutaneous coronary intervention: a report from the Cardiac Safety Research Consortium.

Journal Article Am Heart J · March 2013 Percutaneous coronary intervention (PCI) is an integral part of the treatment of coronary artery disease. The most common complication of PCI, bleeding, typically occurs at the vascular access site and is associated with short-term and long-term morbidity ... Full text Link to item Cite

Global cardiovascular device innovation: Japan-USA synergies: Harmonization by Doing (HBD) program, a consortium of regulatory agencies, medical device industry, and academic institutions.

Journal Article Circ J · 2013 BACKGROUND: Global medical devices have become more popular, but investment money for medical device development is not easily available in the market. Worldwide health-care budget constraints mean that efficient medical device development has become essen ... Full text Link to item Cite

Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.

Journal Article J Thorac Cardiovasc Surg · January 2013 OBJECTIVES: The aim of the current Valve Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI) clinical endpoints to make them more suitable to the present and future ... Full text Link to item Cite

Intravenous immunoglobulin plus corticosteroid to prevent coronary artery abnormalities in Kawasaki disease: a meta-analysis.

Journal Article Heart · January 2013 OBJECTIVE: To summarise clinical trials that compared the incidence of coronary abnormality between intravenous immune globulin (IVIG) plus corticosteroid therapy and IVIG therapy alone, and to determine the overall efficacy and safety of IVIG plus cortico ... Full text Link to item Cite

Sustained low clinical event rates in real-world patients receiving everolimus-eluting coronary stent system from a large, prospective, condition of approval study: 2-year clinical outcomes from the XIENCE V USA Study.

Journal Article J Interv Cardiol · December 2012 OBJECTIVES: This 2-year follow-up of the XIENCE V USA study examines both the long-term safety and effectiveness of the everolimus-eluting coronary stent system (EECSS) in real-world patients. BACKGROUND: The safety and effectiveness of EECSS at 1 year in ... Full text Link to item Cite

Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.

Journal Article EuroIntervention · November 22, 2012 OBJECTIVES: The aim of the current Valvular Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI)- clinical endpoints to make them more suitable to the present and fu ... Full text Link to item Cite

Anatomic and Physiologic Determinants of the Area-at-Risk Differentiate in Range of Infarct Size among Patients Undergoing Primary Percutaneous Coronary Intervention

Conference CIRCULATION · November 20, 2012 Link to item Cite

Lower Education Level is Associated with Non-Adherence to Dual Antiplatelet Therapy After PCI: 6-Month Results from PARIS

Conference CIRCULATION · November 20, 2012 Link to item Cite

Current approaches to prevention and management of reperfusion injury

Chapter · November 1, 2012 As our understanding of the pathophysiological underpinnings of reperfusion injury has increased, many therapies directed at preventing the detrimental effects of this phenomenon have been tested. For primary PCI, this has ranged from mechanical protection ... Full text Cite

Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document (VARC-2).

Journal Article Eur J Cardiothorac Surg · November 2012 OBJECTIVES: The aim of the current Valve Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI) clinical endpoints to make them more suitable to the present and future ... Full text Link to item Cite

Effect of cardiac resynchronization therapy and implantable cardioverter defibrillator on quality of life in patients with heart failure: a meta-analysis.

Journal Article Europace · November 2012 AIMS: To compare the improvement of quality of life (QoL) in cardiac resynchronization therapy plus implantable cardioverter defibrillator (CRT-D) therapy with that in implantable cardioverter defibrillator (ICD) therapy alone for patients with heart failu ... Full text Link to item Cite

Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.

Journal Article J Am Coll Cardiol · October 9, 2012 OBJECTIVES: The aim of the current Valve Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI) clinical endpoints to make them more suitable to the present and future ... Full text Link to item Cite

Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.

Journal Article Eur Heart J · October 2012 OBJECTIVES: The aim of the current Valve Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI)clinical endpoints to make them more suitable to the present and future ... Full text Link to item Cite

Pediatric cardiovascular safety: challenges in drug and device development and clinical application.

Journal Article Am Heart J · October 2012 Development of pediatric medications and devices is complicated by differences in pediatric physiology and pathophysiology (both compared with adults and within the pediatric age range), small patient populations, and practical and ethical challenges to de ... Full text Link to item Cite

Should rhythm control be preferred in younger atrial fibrillation patients?

Journal Article J Interv Card Electrophysiol · October 2012 PURPOSE: Rate- and rhythm control are two fundamental strategies to treat atrial fibrillation (AF). However, there are inconsistent results between clinical trials about which treatment should be preferred. The aims of this study were to systematically sum ... Full text Link to item Cite

The comparison of epicardial focused ultrasound circumferential pulmonary vein ablation and BOX ablation--results from experimental acute atrial fibrillation.

Journal Article J Interv Card Electrophysiol · August 2012 PURPOSE: The purpose of this study was to compare the efficacy of focused ultrasound circumferential pulmonary vein ablation (CPVa) and BOX ablation (BOXa) in an acute atrial fibrillation (AF) model. METHODS: Twenty mongrel dogs were divided into either CP ... Full text Link to item Cite

Percutaneous atrial septal occluder devices and cardiac erosion: a review of the literature.

Journal Article Catheter Cardiovasc Interv · August 1, 2012 OBJECTIVE: To systematically review all cases in the literature of erosion associated with atrial septal defect (ASD) occluder devices. BACKGROUND: Delayed erosion of the aortic or atrial wall is an infrequent but potentially lethal complication of percuta ... Full text Link to item Cite

Medical device innovation: prospective solutions for an ecosystem in crisis. Adding a professional society perspective.

Journal Article JACC Cardiovasc Interv · July 2012 Barriers to medical device innovation compromise timelines and costs from bench to bedside. Fragmented strategies by individual competitors are no longer sustainable. Pragmatically focused pre-competitive collaboration across stakeholders approaches innova ... Full text Link to item Cite

Contemporary incidence and predictors of stent thrombosis and other major adverse cardiac events in the year after XIENCE V implantation: results from the 8,061-patient XIENCE V United States study.

Journal Article JACC Cardiovasc Interv · June 2012 OBJECTIVES: The aim of this study was to identify predictors of clinical events after XIENCE V (Abbott Vascular, Santa Clara, California) stenting. BACKGROUND: The XIENCE V USA (XIENCE V Everolimus Eluting Coronary Stent System [EECSS] USA Post-Approval) s ... Full text Link to item Cite

Multiple biomarkers at admission are associated with angiographic, electrocardiographic, and imaging cardiovascular mechanistic markers of outcomes in patients undergoing primary percutaneous coronary intervention for acute ST-elevation myocardial infarction.

Journal Article Am Heart J · May 2012 BACKGROUND: The multimarker risk score, based on estimated glomerular filtration rate, glucose, and N-terminal probrain natriuretic peptide (NT-proBNP), has been shown to predict mortality in patients with ST-segment elevation myocardial infarction (STEMI) ... Full text Link to item Cite

Detection of QT prolongation using a novel electrocardiographic analysis algorithm applying intelligent automation: prospective blinded evaluation using the Cardiac Safety Research Consortium electrocardiographic database.

Journal Article Am Heart J · March 2012 BACKGROUND: The Cardiac Safety Research Consortium (CSRC) provides both "learning" and blinded "testing" digital electrocardiographic (ECG) data sets from thorough QT (TQT) studies annotated for submission to the US Food and Drug Administration (FDA) to de ... Full text Link to item Cite

Randomized, controlled study of telcagepant in patients with migraine and coronary artery disease.

Journal Article Headache · February 2012 OBJECTIVE: To evaluate the efficacy of telcagepant in patients with migraine and coronary artery disease. BACKGROUND: Calcitonin gene-related peptide receptor antagonists, such as telcagepant, may be useful for acute migraine treatment in patients with car ... Full text Link to item Cite

Arterial and Venous Access and Hemostasis for PCI

Chapter · January 1, 2012 Full text Cite

Comparison of an automated algorithm to expert physician interpretation of 80-lead body surface mapping in the evaluation of acute myocardial ischemia and infarction in patients presenting to the emergency department with chest pain: results from the Optimal Cardiovascular Diagnostic Evaluation Enabling Faster Treatment of Myocardial Infarction trial.

Journal Article J Electrocardiol · 2012 INTRODUCTION/BACKGROUND: Eighty-lead (80 L) body surface map (BSM) technology provides electrocardiogram data for the clinician to interpret. A BSM device also offers an automated interpretation. Little information is available about the performance of aut ... Full text Link to item Cite

Intravascular ultrasound insights from the Cobalt Chromium Stent With Antiproliferative for Restenosis II (COSTAR II) trial comparing CoStar and Taxus paclitaxel-eluting stents.

Journal Article Cardiovasc Revasc Med · 2012 BACKGROUND: Dedicated IVUS analyses of the second CObalt chromium STent with Antiproliferative for Restenosis (COSTAR II) trial have not been documented. We aim to compare IVUS findings between CoStar paclitaxel-eluting stent (PES) and Taxus PES in patient ... Full text Link to item Cite

A new era of prospective real-world safety evaluation primary report of XIENCE V USA (XIENCE V Everolimus Eluting Coronary Stent System condition-of-approval post-market study).

Journal Article JACC Cardiovasc Interv · December 2011 OBJECTIVES: The XIENCE V USA (XIENCE V Everolimus Eluting Coronary Stent System Condition-of-Approval Post-Market study) sought to: 1) evaluate the safety of everolimus-eluting coronary stent systems (EECSS) in a contemporary cohort of real-world subjects; ... Full text Link to item Cite

Prediction of Myocardial Infarct Size Using Multiple Concomitant Angiographic, Biochemical and Electrocardiographic Biomarkers in Patients with ST-Segment Elevation Myocardial Infarction Treated with Primary Percutaneous Coronary Intervention

Journal Article CIRCULATION · November 22, 2011 Link to item Cite

Diastolic Heart Failure - Innovative Extra and Intra Ventricular Solutions

Conference JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY · November 8, 2011 Link to item Cite

Post-Procedural ST-segment Deviation is an Independent Predictor of Long-Term Mortality in Patients Undergoing Primary Percutaneous Coronary Intervention for ST-segment Elevation Myocardial Infarction

Conference JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY · November 8, 2011 Link to item Cite

One-Year Clinical Outcomes and Multivariate Predictors Following XIENCE V (R) Everolimus Eluting Coronary Stent System Implantation in Real-World Clinical Settings

Conference JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY · November 8, 2011 Link to item Cite

Stent Thrombosis and Dual Antiplatelet Interruption: Insights from the XIENCE V Everolimus-Eluting Coronary Stent System Trials

Conference JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY · November 8, 2011 Link to item Cite

The Impact of XIENCE V (R) Everolimus-Eluting Coronary Stents on Health Status in COURAGE-Like Patients

Conference JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY · November 8, 2011 Link to item Cite

Stent Thrombosis after Implantation of XIENCE V Everolimus-Eluting Coronary Stent Systems in On-label and Off-label Populations: Pooled Two-Year Results from Seven XIENCE V Coronary Stent Trials

Conference JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY · November 8, 2011 Link to item Cite

Reply

Journal Article JACC: Cardiovascular Interventions · October 1, 2011 Full text Cite

Toward a more materialistic medicine: the value of authentic materialism within current and future medical practice.

Journal Article J Altern Complement Med · September 2011 Modern medicine is often accused by diverse critics of being "too materialistic" and therefore insufficiently holistic and effective. Yet, this critique can be misleading, dependent upon the ambiguous meanings of "materialism." The term can refer to the pr ... Full text Link to item Cite

Learning to walk before we run: the mechanics of medical intervention for peripheral arterial disease.

Journal Article J Am Coll Cardiol · August 30, 2011 Full text Link to item Cite

Troponin measurements during drug development--considerations for monitoring and management of potential cardiotoxicity: an educational collaboration among the Cardiac Safety Research Consortium, the Duke Clinical Research Institute, and the US Food and Drug Administration.

Journal Article Am Heart J · July 2011 Drug-induced cardiac toxicity is a recognized challenge in development and implementation of pharmacotherapy. Appropriate biomarkers are needed to detect these abnormalities early in development and to manage the risk of potentially cardiotoxic drugs or bi ... Full text Link to item Cite

Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform. Report of a policy conference of the European Society of Cardiology.

Journal Article Eur Heart J · July 2011 The European Commission announced in 2008 that a fundamental revision of the medical device directives is being considered in order to clarify and strengthen the current legal framework. The system for testing and approving devices in Europe was establishe ... Full text Link to item Cite

Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium.

Journal Article Circulation · June 14, 2011 Full text Link to item Cite

Effect of telcagepant on spontaneous ischemia in cardiovascular patients in a randomized study.

Journal Article Headache · June 2011 OBJECTIVE: The primary purpose of the study was to explore the safety and tolerability of telcagepant in patients with stable coronary artery disease. BACKGROUND: Triptans are effective acute anti-migraine drugs whose vasoconstrictive effects limit their u ... Full text Link to item Cite

Commentary: International collaboration needed on device clinical standards.

Journal Article BMJ · May 13, 2011 Full text Link to item Cite

Autopsy validation study of the academic research consortium stent thrombosis definition.

Journal Article JACC Cardiovasc Interv · May 2011 OBJECTIVES: This study sought to validate the sensitivity and specificity of the Academic Research Consortium's (ARC) classification of stent thrombosis. BACKGROUND: Classification of stent thrombosis according to ARC criteria has become widely accepted. T ... Full text Link to item Cite

The academic research consortium governance charter.

Journal Article JACC Cardiovasc Interv · May 2011 Full text Link to item Cite

Focus on the cardiac safety research consortium

Journal Article Drug Information Journal · May 1, 2011 This is the first in a series of "Focus On" columns that will appear in the journal from time to time. Each column will present an overview of an academic center, not-for-profit organization, or public-private partnership in the health care domain. The Car ... Full text Cite

PREDICTION OF DEATH AND CONGESTIVE HEART FAILURE USING MULTIPLE CONCOMITANT ANGIOGRAPHIC BIOCHEMICAL AND ELECTROCARDIOGRAPHIC BIOMARKERS IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION TREATED WITH PRIMARY PERCUTANEOUS CORONARY INTERVENTION

Conference Journal of the American College of Cardiology · April 2011 Full text Cite

CLINICAL OUTCOMES IN REAL-WORLD PATIENTS RECEIVING THE XIENCE V® EVEROLIMUS-ELUTING STENT PRESENTING WITH CHRONIC KIDNEY DISEASE: ONE-YEAR RESULTS FROM THE XIENCE V USA STUDY

Conference Journal of the American College of Cardiology · April 2011 Full text Cite

Transradial PCI in women: problem solved or clinical equipoise?

Journal Article J Invasive Cardiol · March 2011 Link to item Cite

Differences in the approval process for interventional devices in Europe and USA: IN MEDIO STAT VIRTUS.

Journal Article EuroIntervention · March 2011 Full text Link to item Cite

Computer-assisted quantification of myocardial reperfusion after primary percutaneous coronary intervention predicts functional and contrast-enhanced cardiovascular magnetic resonance outcomes in patients with ST-segment elevation myocardial infarction.

Journal Article Catheter Cardiovasc Interv · February 1, 2011 OBJECTIVE: We investigated whether the Quantitative Blush Evaluator (QuBE) value predicts functional and contrast-enhanced cardiovascular magnetic resonance (CMR) outcomes at 4-6 months after primary percutaneous coronary intervention (PCI) inpatients with ... Full text Link to item Cite

Standardized endpoint definitions for Transcatheter Aortic Valve Implantation clinical trials: a consensus report from the Valve Academic Research Consortium.

Journal Article J Am Coll Cardiol · January 18, 2011 OBJECTIVES: To propose standardized consensus definitions for important clinical endpoints in transcatheter aortic valve implantation (TAVI), investigations in an effort to improve the quality of clinical research and to enable meaningful comparisons betwe ... Full text Link to item Cite

The clinical evaluation of the Endeavor zotarolimus-eluting coronary stent in Japanese patients with de novo native coronary artery lesions: primary results and 3-year follow-up of the Endeavor Japan study.

Journal Article Cardiovasc Revasc Med · 2011 BACKGROUND: Angiographic and clinical outcomes associated with coronary stents eluting the new molecular entity zotarolimus have been well characterized in a variety of geographies and patient subsets. The Endeavor Japan study is the first prospective clin ... Full text Link to item Cite

Transradial PCI in women: Problem solved or clinical equipoise?

Journal Article Journal of Invasive Cardiology · January 1, 2011 Cite

Impact of early, late, and no ST-segment resolution measured by continuous ST Holter monitoring on left ventricular ejection fraction and infarct size as determined by cardiovascular magnetic resonance imaging.

Journal Article J Electrocardiol · 2011 BACKGROUND: The goal of this study is to determine the predictive value of ST-segment resolution (STR) early after percutaneous coronary intervention (PCI), late STR, and no STR for left ventricular ejection fraction (LVEF) and infarct size (IS) by cardiov ... Full text Link to item Cite

Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium.

Journal Article Eur Heart J · January 2011 OBJECTIVES: To propose standardized consensus definitions for important clinical endpoints in transcatheter aortic valve implantation (TAVI), investigations in an effort to improve the quality of clinical research and to enable meaningful comparisons betwe ... Full text Link to item Cite

The Cardiac Safety Research Consortium electrocardiogram warehouse: thorough QT database specifications and principles of use for algorithm development and testing.

Journal Article Am Heart J · December 2010 This document examines the formation, structure, and principles guiding the use of electrocardiogram (ECG) data sets obtained during thorough QT studies that have been derived from the ECG Warehouse of the Cardiac Safety Research Consortium (CSRC). These p ... Full text Link to item Cite

Predictors of 1-Year Clinical Outcomes in Real World Patients from XIENCE V (R) USA Study.

Conference CIRCULATION · November 23, 2010 Link to item Cite

Low Clinical Event Rates in Real-World Patients with Acute Myocardial Infarction Receiving XIENCE V (R) Everolimus-Eluting Stents: One-Year Results from the XIENCE V USA Study

Conference CIRCULATION · November 23, 2010 Link to item Cite

Proximal embolic protection in patients undergoing primary angioplasty for acute myocardial infarction (PREPARE): core lab adjudicated angiographic outcomes of a randomised controlled trial.

Journal Article Neth Heart J · November 2010 BACKGROUND: Patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI) with the Proxis system (St. Jude Medical, St. Paul, MN, USA) achieved significantly better microvascular flow as meas ... Full text Link to item Cite

Developing the Safety of Atrial Fibrillation Ablation Registry Initiative (SAFARI) as a collaborative pan-stakeholder critical path registry model: a Cardiac Safety Research Consortium "Incubator" Think Tank.

Journal Article Am Heart J · October 2010 Although several randomized clinical trials have demonstrated the safety and efficacy of catheter ablation of atrial fibrillation (AF) in experienced centers, the outcomes of this procedure in routine clinical practice and in patients with persistent and l ... Full text Link to item Cite

Electrocardiographic assessment for therapeutic proteins--scientific discussion.

Journal Article Am Heart J · October 2010 Electrocardiographic monitoring is an integral component of the clinical assessment of cardiac safety of all compounds in development. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use ... Full text Link to item Cite