Abstract:
Importance:Physicians have been criticized for having an overly enthusiastic response to new device approvals, especially for novel technologies. However, to our knowledge, the rates of new product adoption and patterns of new device usage in clinical practice have not been well described. Objective:To characterize the patterns of uptake of bioresorbable vascular scaffolds (BVS) within the United States following device approval and to describe changes in response to subsequent releases of data and US Food and Drug Administration (FDA) warnings. Design, Setting, and Participants:This analysis of the uptake of BVS between January 2016 and June 2017 used CathPCI Registry data; all percutaneous coronary intervention (PCI) procedures with an implant of either a BVS or conventional stent were included. Data analysis was performed in October 2017. Exposures:Implant of BVS. Main Outcomes and Measures:The primary outcome was monthly use of BVS in the United States. In addition, the characteristics of patients who received BVS and of hospitals that used BVS were assessed and comparisons of patient characteristics between BVS recipients and patients who were treated contemporaneously with metallic stents were made. Results:Of 682 951 procedures, 471 064 (69.0%) were done in men, 587 301 (86.0%) were among white people, and the mean (SD) age of those undergoing procedures with BVS vs conventional stents was 62.6 (11.4) years vs 65.7 (11.9) years. Of these, 4265 procedures (0.6%) used BVS overall (after FDA approval of BVS). Procedures with implants of BVS occurred among patients with fewer comorbidities and lower-acuity presentations compared with procedures with implants of conventional stents. The patient characteristics for BVS use were not dissimilar to the inclusion criteria of the ABSORB III FDA approval trial, with notable differences based on trial eligibility (eg, excluding patients with myocardial infarctions). The maximum monthly use of BVS was 1.25% of all PCI procedures that occurred 90 days after FDA approval, but with site-to-site variability. Declines in use were observed coincident with the scientific presentation of adverse event data as well as FDA warnings. Conclusions and Relevance:Most US physicians and hospitals were selective in their use of BVS, primarily using them in patients similar to those in the device's FDA approval trial. In addition, declines in use were evident in the subsequent month following the release of data that reported negative outcomes. These results illustrate an example of an appropriate physician response to adverse data updates and FDA warnings.
journal_name
JAMA Cardioljournal_title
JAMA cardiologyauthors
Chau KH,Kennedy KF,Messenger JC,Garratt KN,Maddox TM,Yeh RW,Kirtane AJdoi
10.1001/jamacardio.2019.0388subject
Has Abstractpub_date
2019-06-01 00:00:00pages
564-568issue
6eissn
2380-6583issn
2380-6591pii
2732486journal_volume
4pub_type
杂志文章相关文献
JAMA Cardiology文献大全abstract:Importance:Recent data support percutaneous revascularization as an alternative to coronary artery bypass grafting in unprotected left main (ULM) coronary lesions. However, the relevance of these trials to current practice is unclear, as patterns and outcomes of ULM percutaneous coronary intervention (PCI) in contempor...
journal_title:JAMA cardiology
pub_type: 杂志文章,多中心研究
doi:10.1001/jamacardio.2018.4376
更新日期:2019-02-01 00:00:00
abstract:Importance:Long-term blood pressure (BP) variability has emerged as a reproducible measure that is associated with heart failure independent of systemic BP. Visit-to-visit BP variability may be associated with the risk of heart failure early in the life course and thus may be reflected in subclinical alterations in car...
journal_title:JAMA cardiology
pub_type: 杂志文章,多中心研究
doi:10.1001/jamacardio.2020.0799
更新日期:2020-07-01 00:00:00
abstract:Importance:Depression is increasingly recognized as a risk factor for adverse outcomes in cardiovascular disease. However, little is known about depression in older adults undergoing transcatheter (TAVR) or surgical (SAVR) aortic valve replacement. Objective:To determine the prevalence of depression and its associatio...
journal_title:JAMA cardiology
pub_type: 杂志文章,多中心研究
doi:10.1001/jamacardio.2017.5064
更新日期:2018-03-01 00:00:00
abstract:Importance:The period following heart failure hospitalization (HFH) is a vulnerable time with high rates of death or recurrent HFH. Objective:To evaluate clinical characteristics, outcomes, and treatment response to vericiguat according to prespecified index event subgroups and time from index HFH in the Vericiguat Gl...
journal_title:JAMA cardiology
pub_type: 杂志文章
doi:10.1001/jamacardio.2020.6455
更新日期:2020-11-13 00:00:00
abstract:Importance:Low-density lipoprotein cholesterol (LDL-C)-lowering therapies are a cornerstone of prevention in atherosclerotic cardiovascular disease. With the introduction of generic formulations and the release of new therapies, including proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, contemporary Me...
journal_title:JAMA cardiology
pub_type: 杂志文章
doi:10.1001/jamacardio.2020.3723
更新日期:2021-01-01 00:00:00
abstract:Importance:Cardiac dysfunction is a leading cause of morbidity and mortality in Duchenne muscular dystrophy (DMD). This case highlights the importance of steroids in treating cardiac complications of DMD and the dangers of discontinuing or switching between steroid classes. Objective:To recognize the presentation of a...
journal_title:JAMA cardiology
pub_type: 杂志文章
doi:10.1001/jamacardio.2018.2695
更新日期:2018-10-01 00:00:00
abstract:Importance:Cardiac stress testing is often performed prior to noncardiac surgery, although trends in use of preoperative stress testing and the effect of testing on cardiovascular outcomes are currently unknown. Objective:To describe temporal trends and outcomes of preoperative cardiac stress testing from 2004 to 2017...
journal_title:JAMA cardiology
pub_type: 杂志文章
doi:10.1001/jamacardio.2020.4311
更新日期:2021-01-01 00:00:00
abstract:Importance:Only 1 class of glucose-lowering agents-sodium-glucose cotransporter 2 (SGLT2) inhibitors-has been reported to decrease the risk of cardiovascular events primarily by reducing the risk of the development or progression of heart failure. In a landmark trial called Empagliflozin, Cardiovascular Outcomes, and M...
journal_title:JAMA cardiology
pub_type: 杂志文章
doi:10.1001/jamacardio.2017.2275
更新日期:2017-09-01 00:00:00
abstract:Importance:Hospitalizations for worsening heart failure (WHF) represent an enormous public health and financial burden, with physicians, health systems, and payers placing increasing emphasis on hospitalization prevention. In addition, maximizing time out of the hospital is an important patient-centered outcome. In thi...
journal_title:JAMA cardiology
pub_type: 杂志文章
doi:10.1001/jamacardio.2017.5250
更新日期:2018-03-01 00:00:00
abstract:Importance:Women are at higher risk of drug-induced torsade de pointes (TdP) than men. Androgens are protective. Influence of oral contraception on drug-induced TdP and QT prolongation is controversial. Objective:To determine if the extent of sotalol-induced corrected QT (QTc) prolongation and specific T-wave morpholo...
journal_title:JAMA cardiology
pub_type: 杂志文章
doi:10.1001/jamacardio.2018.2251
更新日期:2018-09-01 00:00:00
abstract:Importance:Observational studies have reported an association between low serum vitamin D levels and elevated risk of cardiovascular disease (CVD) events, but such studies cannot prove causation because of possible unmeasured confounding. Objective:We conducted a meta-analysis of randomized clinical trials that tested...
journal_title:JAMA cardiology
pub_type: 杂志文章,meta分析
doi:10.1001/jamacardio.2019.1870
更新日期:2019-08-01 00:00:00
abstract:IMPORTANCE:Dyslipidemia in young adults in the United States during their childbearing years is common, and the consequences for the next generation are poorly understood. Further understanding of the harmful consequences of elevated low-density lipoprotein cholesterol (LDL-C) levels in young adults may help to inform ...
journal_title:JAMA cardiology
pub_type: 杂志文章
doi:10.1001/jamacardio.2015.0304
更新日期:2016-04-01 00:00:00
abstract:IMPORTANCE:Although survival of patients with in-hospital cardiac arrest varies markedly among hospitals, specific resuscitation practices that distinguish sites with higher cardiac arrest survival rates remain unknown. OBJECTIVE:To identify resuscitation practices associated with higher rates of in-hospital cardiac a...
journal_title:JAMA cardiology
pub_type: 杂志文章
doi:10.1001/jamacardio.2016.0073
更新日期:2016-05-01 00:00:00
abstract:Importance:Increasing cardiology workforce diversity will expand the talent of the applicant pool and may reduce health care disparities. Objective:To assess US cardiology physician workforce demographics by sex and race/ethnicity in the context of the US population and the available pipelines of trainees. Design, Se...
journal_title:JAMA cardiology
pub_type: 杂志文章
doi:10.1001/jamacardio.2019.3247
更新日期:2019-10-01 00:00:00
abstract:Importance:Cardiac biomarkers provide insights into pathophysiologic processes and offer an attractive strategy for the assessment of cardiovascular risk. Objective:To assess the incremental prognostic value of biomarkers that reflect different pathophysiologic processes in patients with type 2 diabetes. Design, Sett...
journal_title:JAMA cardiology
pub_type: 杂志文章
doi:10.1001/jamacardio.2016.3030
更新日期:2016-12-01 00:00:00
abstract:Importance:Acute mental stress can result in transient endothelial dysfunction, but the prognostic relevance of this phenomenon is unknown. Objective:To determine the association between mental stress-induced impairment in endothelium-dependent relaxation as assessed by brachial artery flow-mediated vasodilation and a...
journal_title:JAMA cardiology
pub_type: 杂志文章
doi:10.1001/jamacardio.2019.3252
更新日期:2019-10-01 00:00:00
abstract:Importance:Accurate, real-time case identification is needed to target interventions to improve quality and outcomes for hospitalized patients with heart failure. Problem lists may be useful for case identification but are often inaccurate or incomplete. Machine-learning approaches may improve accuracy of identificatio...
journal_title:JAMA cardiology
pub_type: 杂志文章
doi:10.1001/jamacardio.2016.3236
更新日期:2016-12-01 00:00:00
abstract:Importance:Strategies for reliable selection of high-risk patients with hypertrophic cardiomyopathy (HCM) for prevention of sudden cardiac death (SCD) with implantable cardioverter/defibrillators (ICDs) are incompletely resolved. Objective:To assess the reliability of SCD prediction methods leading to prophylactic ICD...
journal_title:JAMA cardiology
pub_type: 杂志文章
doi:10.1001/jamacardio.2019.1391
更新日期:2019-07-01 00:00:00
abstract:Importance:Cohort studies have reported increased incidence of cardiovascular disease (CVD) among individuals with low vitamin D status. To date, randomized clinical trials of vitamin D supplementation have not found an effect, possibly because of using too low a dose of vitamin D. Objective:To examine whether monthly...
journal_title:JAMA cardiology
pub_type: 杂志文章,随机对照试验
doi:10.1001/jamacardio.2017.0175
更新日期:2017-06-01 00:00:00
abstract::P values and hypothesis testing methods are frequently misused in clinical research. Much of this misuse appears to be owing to the widespread, mistaken belief that they provide simple, reliable, and objective triage tools for separating the true and important from the untrue or unimportant. The primary focus in inter...
journal_title:JAMA cardiology
pub_type: 杂志文章
doi:10.1001/jamacardio.2016.3312
更新日期:2016-12-01 00:00:00
abstract:Importance:Bioresorbable scaffolds were designed to provide clinical benefits after their complete bioresorption. Prior studies demonstrated early risks with the Absorb polymeric bioresorbable vascular scaffold (BVS). Whether this risk profile changes over time during the course of its bioresorption is unknown. Object...
journal_title:JAMA cardiology
pub_type: 杂志文章,meta分析
doi:10.1001/jamacardio.2019.4101
更新日期:2019-12-01 00:00:00
abstract:Importance:Echocardiographic left ventricular global longitudinal strain (GLS) detects early subclinical ventricular dysfunction and can be used in patients receiving potentially cardiotoxic chemotherapy. A meta-analysis of the prognostic value of GLS for cancer therapy-related cardiac dysfunction (CTRCD) has not been ...
journal_title:JAMA cardiology
pub_type: 杂志文章,meta分析
doi:10.1001/jamacardio.2019.2952
更新日期:2019-10-01 00:00:00
abstract:Importance:Transcatheter aortic valve replacement (TAVR) is an established alternative to surgery for patients with severe symptomatic aortic stenosis. Adjunctive antithrombotic therapy used to mitigate thrombotic risks in patients undergoing TAVR must be balanced against bleeding complications, since both are associat...
journal_title:JAMA cardiology
pub_type: 杂志文章,评审
doi:10.1001/jamacardio.2019.4367
更新日期:2020-01-01 00:00:00
abstract:Importance:In clinical trials, transcatheter aortic valve replacement (TAVR) has been shown to improve symptoms and quality of life. As this technology moves into general clinical practice, evaluation of the health status outcomes among unselected patients treated with TAVR is of critical importance. Objective:To exam...
journal_title:JAMA cardiology
pub_type: 杂志文章,多中心研究
doi:10.1001/jamacardio.2016.5302
更新日期:2017-04-01 00:00:00
abstract:Importance:Despite considerable improvements in heart failure care, mortality rates among patients in high-income countries have changed little since the early 2000s. Understanding the reasons underlying these trends may provide valuable clues for developing more targeted therapies and public health strategies. Object...
journal_title:JAMA cardiology
pub_type: 杂志文章
doi:10.1001/jamacardio.2019.3593
更新日期:2019-11-01 00:00:00
abstract:Importance:The Systolic Blood Pressure Intervention Trial (SPRINT) demonstrated the benefit of lowering systolic blood pressure (SBP) to 120 mm Hg, yet other trials, such as Heart Outcomes Prevention Evaluation-3 (HOPE-3), did not find consistent benefit. How to incorporate these results into the treatment of those wit...
journal_title:JAMA cardiology
pub_type: 杂志文章
doi:10.1001/jamacardio.2016.2861
更新日期:2016-11-01 00:00:00
abstract:Importance:Little is known about the influence of comprehensive public health initiatives according to out-of-hospital cardiac arrest (OHCA) location, particularly at home, where resuscitation efforts and outcomes have historically been poor. Objective:To describe temporal trends in bystander cardiopulmonary resuscita...
journal_title:JAMA cardiology
pub_type: 杂志文章
doi:10.1001/jamacardio.2017.3471
更新日期:2017-11-01 00:00:00
abstract:Importance:As many as 10% of women experience natural menopause by the age of 45 years. If confirmed, an increased risk of cardiovascular disease (CVD) and all-cause mortality associated with premature and early-onset menopause could be an important factor affecting risk of disease and mortality among middle-aged and o...
journal_title:JAMA cardiology
pub_type: 杂志文章,meta分析,评审
doi:10.1001/jamacardio.2016.2415
更新日期:2016-10-01 00:00:00
abstract:Importance:Quality of percutaneous coronary intervention (PCI) is commonly assessed by risk-adjusted mortality. However, this metric may result in procedural risk aversion, especially for high-risk patients. Objective:To determine correlation and reclassification between hospital-level disease-specific mortality and P...
journal_title:JAMA cardiology
pub_type: 杂志文章,多中心研究
doi:10.1001/jamacardio.2020.0753
更新日期:2020-07-01 00:00:00
abstract:Importance:It is unknown whether coronary revascularization, when added to optimal medical therapy, improves prognosis in patients with stable ischemic heart disease (SIHD) at increased risk of cardiovascular events owing to moderate or severe ischemia. Objective:To describe baseline characteristics of participants en...
journal_title:JAMA cardiology
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1001/jamacardio.2019.0014
更新日期:2019-03-01 00:00:00