2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS guideline for the diagnosis and management of patients with stable ischemic heart disease

The recommendations listed in this document are, whenever possible, evidence based. An extensive evidence review was conducted as the document was compiled through December 2008. Repeated literature searches were performed by the guideline development staff and writing committee members as new issues were considered. New clinical trials published in peer-reviewed journals and articles through December 2011 were also reviewed and incorporated when relevant. Furthermore, because of the extended development time period for this guideline, peer review comments indicated that the sections focused on imaging technologies required additional updating, which occurred during 2011. Therefore, the evidence review for the imaging sections includes published literature through December 2011

Monitoring Device Safety in Interventional Cardiology

Objective: A variety of postmarketing surveillance strategies to monitor the safety of medical devices have been supported by the U.S. Food and Drug Administration, but there are few systems to automate surveillance. Our objective was to develop a system to perform real-time monitoring of safety data using a variety of process control techniques. Design: The Web-based Data Extraction and Longitudinal Time Analysis (DELTA) system imports clinical data in real-time from an electronic database and generates alerts for potentially unsafe devices or procedures. The statistical techniques used are statistical process control (SPC), logistic regression (LR), and Bayesian updating statistics (BUS). Measurements: We selected in-patient mortality following implantation of the Cypher drug-eluting coronary stent to evaluate our system. Data from the University of Michigan Consortium Bare-Metal Stent Study was used to calculate the event rate alerting boundaries. Data analysis was performed on local catheterization data from Brigham and Women's Hospital from July 1, 2003, shortly after the Cypher release, to December 31, 2004, including 2,270 cases with 27 observed deaths. Results: The single-stratum SPC had alerts in months 4 and 10. The multistrata SPC had alerts in months 5, 10, and 18 in the moderate-risk stratum, and months 1, 4, 7, and 10 in the high-risk stratum. The only cumulative alerts were in the first month for the high-risk stratum of the multistrata SPC. The LR method showed no monthly or cumulative alerts. The BUS method showed an alert in the first month for the high-risk stratum. Conclusion: The system performed adequately within the Brigham and Women's Hospital Intranet environment based on the design goals. All three cumulative methods agreed that the overall observed event rates were not significantly higher for the new medical device than for a closely related medical device and were consistent with the observation that the initial concerns about this device dissipated as more data accumulated

A comparison of in-hospital acute myocardial infarction management between Portugal and the United States : 2000–2010

© The Author 2017. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: [email protected]: To compare healthcare in acute myocardial infarction (AMI) treatment between contrasting health systems using comparable representative data from Europe and USA. Design: Repeated cross-sectional retrospective cohort study. Setting: Acute care hospitals in Portugal and USA during 2000-2010. Participants: Adults discharged with AMI. Interventions: Coronary revascularizations procedures (percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) surgery). Main Outcome Measures: In-hospital mortality and length of stay. Results: We identified 1 566 601 AMI hospitalizations. Relative to the USA, more hospitalizations in Portugal presented with elevated ST-segment, and fewer had documented comorbidities. Age-sex-adjusted AMI hospitalization rates decreased in USA but increased in Portugal. Crude procedure rates were generally lower in Portugal (PCI: 44% vs. 47%; CABG: 2% vs. 9%, 2010) but only CABG rates differed significantly after standardization. PCI use increased annually in both countries but CABG decreased only in the USA (USA: 0.95 [0.94, 0.95], Portugal: 1.04 [1.02, 1.07], odds ratios). Both countries observed annual decreases in risk-adjusted mortality (USA: 0.97 [0.965, 0.969]; Portugal: 0.99 [0.979, 0.991], hazard ratios). While between-hospital variability in procedure use was larger in USA, the risk of dying in a high relative to a low mortality hospital (hospitals in percentiles 95 and 5) was 2.65 in Portugal when in USA was only 1.03. Conclusions: Although in-hospital mortality due to an AMI improved in both countries, patient management in USA seems more effective and alarming disparities in quality of care across hospitals are more likely to exist in Portugal.This paper was funded by the Harvard Medical School—Portugal Program [HMSP-ICT/0013/2011]. Armando Teixeira-Pinto was partially supported by National Health and Medical Research Council through the Screening & Test Evaluation Program [grant number 633003]. Project Macro-to-Nano human sensing: towards integrated multimodal health monitoring and analytics (NanoSTIMA) [NORTE-01-0145-FEDER-000016] is financed by the North Portugal Regional Operational Programme (NORTE 2020), under the PORTUGAL 2020 Partnership Agreement, and through the European Regional Development Fund (ERDF).info:eu-repo/semantics/publishedVersio

A Prospective Feasibility Trial Investigating the Use of the Impella 2.5 System in Patients Undergoing High-Risk Percutaneous Coronary Intervention (The PROTECT I Trial) Initial U.S. Experience

ObjectivesWe sought to evaluate the safety and feasibility of the Impella 2.5 system (Abiomed Inc., Danvers, Massachusetts) in patients undergoing high-risk percutaneous coronary intervention (PCI).BackgroundThe Impella 2.5 is a miniaturized percutaneous cardiac assist device, which provides up to 2.5 l/min forward flow from the left ventricle into the systemic circulation.MethodsIn a prospective, multicenter study, 20 patients underwent high-risk PCI with minimally invasive circulatory support employing the Impella 2.5 system. All patients had poor left ventricular function (ejection fraction ≤35%) and underwent PCI on an unprotected left main coronary artery or last patent coronary conduit. Patients with recent ST-segment elevation myocardial infarction or cardiogenic shock were excluded. The primary safety end point was the incidence of major adverse cardiac events at 30 days. The primary efficacy end point was freedom from hemodynamic compromise during PCI (defined as a decrease in mean arterial pressure below 60 mm Hg for >10 min).ResultsThe Impella 2.5 device was implanted successfully in all patients. The mean duration of circulatory support was 1.7 ± 0.6 h (range: 0.4 to 2.5 h). Mean pump flow during PCI was 2.2 ± 0.3 l/min. At 30 days, the incidence of major adverse cardiac events was 20% (2 patients had a periprocedural myocardial infarction; 2 patients died at days 12 and 14). There was no evidence of aortic valve injury, cardiac perforation, or limb ischemia. Two patients (10%) developed mild, transient hemolysis without clinical sequelae. None of the patients developed hemodynamic compromise during PCI.ConclusionsThe Impella 2.5 system is safe, easy to implant, and provides excellent hemodynamic support during high-risk PCI. (The PROTECT I Trial; NCT00534859

A divisão atlântica na doença coronária : epidemiologia e cuidados de saúde nos Estados Unidos e Portugal

© 2017 Sociedade Portuguesa de Cardiologia. Published by Elsevier España, S.L.U. All rights reserved.Introduction and Objectives: We aimed to compare access to new health technologies to treat coronary heart disease (CHD) in the health systems of Portugal and the US, characterizing the needs of the populations and the resources available. Methods: We reviewed data for 2000 and 2010 on epidemiologic profiles of CHD and on health care available to patients. Thirty health technologies (16 medical devices and 14 drugs) introduced during the period 1980-2015 were identified by interventional cardiologists. Approval and marketing dates were compared between countries. Results: Relative to the US, Portugal has lower risk profiles and less than halfthe hospitalizations per capita, but fewer centers per capita provide catheterization and cardiothoracic surgery services. More than 70% of drugs were available sooner in the US, whereas 12 out of 16 medical devices were approved earlier in Portugal. Nevertheless, at least five of these devices were adopted first or diffused fasterin the US. Mortality due to CHD and myocardial infarction (MI) was lower in Portugal (CHD: 72.8 vs. 168 and MI: 48.7 vs. 54.1 in Portugal and the US, respectively; age- and gender-adjusted deaths per 100 000 population, 2010); but only CHD deaths exhibited a statistically significant difference between the countries. Conclusions: Differences in regulatory mechanisms and price regulations have a significant impact on the types of health technologies available in the two countries. However, other factors may influence their adoption and diffusion, and this appears to have a greater impact on mortality, due to acute conditions.Introdução e objetivos: O objetivo deste estudo é comparar o acesso a novas tecnologias em saúde no tratamento da doença coronária (CHD), entre os sistemas de saúde de Portugal e dos Estados Unidos (US), caracterizando as necessidades das populações e disponibilidade de recursos. Métodos:Foram comparados dados (2000 e 2010) de Portugal e US para descrever perfis epidemiológicos e recursos disponíveis na prestação cuidados de saúde na CHD. Trinta tecnologias de saúde (16 dispositivos médicos e 14 medicamentos), introduzidas durante 1980-2015, foram identificadas por cardiologistas de intervenção e calcularam-se as diferenças entre as datas de autorização de introdução no mercado/comercialização nos dois países. Resultados: Relativamente aos US, Portugal apresenta perfis de risco mais baixos, menos hospitalizações per capita, menor número de centros per capita com valência para cateterismo coronário e cirurgia cardiotorácica. Mais de 70% dos medicamentos foram comercializados mais cedo nos US, enquanto 12 dos 16 dispositivos médicos obtiveram autorização para comercialização mais cedo em Portugal. Contudo, pelo menos cinco destes dispositivos foram adotados primeiro ou sofreram uma difusão mais rápida nos US. A mortalidade por CHD e enfarte agudo do miocárdio (EAM) foi inferior em Portugal (CHD: 72,8 [Portugal] versus 168 [US]; AMI: 48,7 [Portugal] versus 54,1 [US]; mortes por 100 000 habitantes, padronizada por idade e sexo, 2010), tendo-se apenas verificado uma diferença significativa entre os países na mortalidade por CHD. Conclusões: Diferenças nos mecanismos de regulação e controlo de preços têm um impacto significativo no tipo de tecnologias disponíveis nos dois países. Contudo, outros fatores influenciam a sua adoção e difusão, tendo um maior impacto na mortalidade em condições mais agudas.This work was supported by the Harvard Medical School - Portugal Program (HMSP-ICT/0013/2011). Armando Teixeira-Pinto was partially supported by National Health and Medical Research Council program grant 633003 to the Screening and Test Evaluation Program (STEP).info:eu-repo/semantics/publishedVersio

A prospective feasibility trial investigating the use of the Impella 2.5 system in patients undergoing high-risk percutaneous coronary intervention (The PROTECT I Trial): initial U.S. experience

We sought to evaluate the safety and feasibility of the Impella 2.5 system (Abiomed Inc., Danvers, Massachusetts) in patients undergoing high-risk percutaneous coronary intervention (PCI). The Impella 2.5 is a miniaturized percutaneous cardiac assist device, which provides up to 2.5 l/min forward flow from the left ventricle into the systemic circulation. In a prospective, multicenter study, 20 patients underwent high-risk PCI with minimally invasive circulatory support employing the Impella 2.5 system. All patients had poor left ventricular function (ejection fraction 10 min). The Impella 2.5 device was implanted successfully in all patients. The mean duration of circulatory support was 1.7 +/- 0.6 h (range: 0.4 to 2.5 h). Mean pump flow during PCI was 2.2 +/- 0.3 l/min. At 30 days, the incidence of major adverse cardiac events was 20% (2 patients had a periprocedural myocardial infarction; 2 patients died at days 12 and 14). There was no evidence of aortic valve injury, cardiac perforation, or limb ischemia. Two patients (10%) developed mild, transient hemolysis without clinical sequelae. None of the patients developed hemodynamic compromise during PCI. The Impella 2.5 system is safe, easy to implant, and provides excellent hemodynamic support during high-risk PCI. (The PROTECT I Trial; NCT00534859