RESUMO
AIMS: The optimal strategy of monitoring for conduction disturbances in patients undergoing transcatheter aortic valve implantation (TAVI) is uncertain. We evaluated a pre- and post-TAVI remote ambulatory cardiac monitoring (rACM) strategy for identification of conduction disturbances and to reduce unplanned pre-discharge post-TAVI permanent pacemaker implantation (PPMI). METHODS AND RESULTS: REdireCT TAVI (NCT0381820) was a prospective cohort study of patients referred for outpatient TAVI. Patients with prior PPMI were excluded. Remote ambulatory cardiac monitoring consisted of 2 weeks of continuous electrocardiogram (ECG) monitoring (Pocket-ECGTM) both before and after TAVI. Compliance to monitoring, frequency of notifications, unplanned PPMI post-TAVI, and length of hospitalization were measured. Between June 2018 and March 2020, in 192 undergoing TAVI (mean age: 81.8 years; female sex 46%; balloon-expandable valve 95.3%), compliance to rACM was 91.7% pre-TAVI (mean duration: 12.8 days), and 87.5% post-TAVI (mean duration: 12.9 days). There were 24 (12.5%) rACM notifications (13 pre-TAVI; 11 post-TAVI) resulting in 14 (7.3%) planned PPMI: seven pre-TAVI [due to sinus pauses n = 2 or atrio-ventricular block (AVB) n = 5] and seven post-TAVI [due to sinus pauses n = 1 or AVB n = 5 or ventricular tachycardia (VT) n = 1]. In addition, nine (4.7%) patients received pre-TAVI PPMI due to high-risk baseline ECG (right bundle branch block with hemi-block or prolonged PR interval). Unplanned PPMI post-TAVI during index hospitalization occurred in six (3.1%) patients due to AVB and in one patient readmitted with AVB. The median length of stay post-TAVI was 1 day. CONCLUSION: A strategy of routine rACM was feasible and frequently led to PPMI. Our approach of 2-week rACM both pre- and post-TAVI achieves both high patient compliance and sufficient surveillance. CLINICAL TRIAL REGISTRATION: Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT03810820.
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Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Marca-Passo Artificial , Substituição da Valva Aórtica Transcateter , Idoso de 80 Anos ou mais , Valva Aórtica , Estenose da Valva Aórtica/cirurgia , Bloqueio de Ramo , Doença do Sistema de Condução Cardíaco , Eletrocardiografia/métodos , Feminino , Próteses Valvulares Cardíacas/efeitos adversos , Humanos , Marca-Passo Artificial/efeitos adversos , Estudos Prospectivos , Fatores de Risco , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Resultado do TratamentoRESUMO
Workplace violence is a common safety concern for hospital staff. The Behaviour Safety Risk Communication and Care Planning program identifies, manages and cares for patients at risk of exhibiting unsafe behaviours. This paper reports on a mixed-methods evaluation consisting of staff surveys, focus groups and open forums, screening audits, patient interviews and assessment of effectiveness measures at five hospital sites. Staff perceptions about safety risk imposed by a patient's behaviour significantly improved after this program was implemented. Opportunities exist to improve staff adherence to screening processes and communication with patients. This study provides insight for teams implementing similar interventions.
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Comunicação , Violência no Trabalho , Grupos Focais , Hospitais , Humanos , Violência no Trabalho/prevenção & controleRESUMO
Workplace violence prevention of patient behaviours is a primary safety focus in hospital settings. In response to provincial mandates, a multi-site tertiary care hospital system developed the Behaviour Safety Risk Communication and Care Planning Program. Components include patient risk screening, communication tools and care plans that outline mitigation strategies. The program has been implemented at six sites using the following strategies: educational and planning meetings, formation of steering committees, identification of champions, educational materials/training, facilitation and consultation, and audit and feedback. Our paper can guide program development and implementation in similar contexts.
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Medição de Risco/métodos , Violência/psicologia , Violência no Trabalho/prevenção & controle , Agressão , Humanos , Pacientes Internados/psicologia , Ontário , Centros de Atenção Terciária , Violência no Trabalho/legislação & jurisprudênciaRESUMO
BACKGROUND: Hypertension is the leading cause of cardiovascular disease globally. Despite proven benefits, hypertension control is poor. We hypothesised that a comprehensive approach to lowering blood pressure and other risk factors, informed by detailed analysis of local barriers, would be superior to usual care in individuals with poorly controlled or newly diagnosed hypertension. We tested whether a model of care involving non-physician health workers (NPHWs), primary care physicians, family, and the provision of effective medications, could substantially reduce cardiovascular disease risk. METHODS: HOPE 4 was an open, community-based, cluster-randomised controlled trial involving 1371 individuals with new or poorly controlled hypertension from 30 communities (defined as townships) in Colombia and Malaysia. 16 communities were randomly assigned to control (usual care, n=727), and 14 (n=644) to the intervention. After community screening, the intervention included treatment of cardiovascular disease risk factors by NPHWs using tablet computer-based simplified management algorithms and counselling programmes; free antihypertensive and statin medications recommended by NPHWs but supervised by physicians; and support from a family member or friend (treatment supporter) to improve adherence to medications and healthy behaviours. The primary outcome was the change in Framingham Risk Score 10-year cardiovascular disease risk estimate at 12 months between intervention and control participants. The HOPE 4 trial is registered at ClinicalTrials.gov, NCT01826019. FINDINGS: All communities completed 12-month follow-up (data on 97% of living participants, n=1299). The reduction in Framingham Risk Score for 10-year cardiovascular disease risk was -6·40% (95% CI 8·00 to -4·80) in the control group and -11·17% (-12·88 to -9·47) in the intervention group, with a difference of change of -4·78% (95% CI -7·11 to -2·44, p<0·0001). There was an absolute 11·45 mm Hg (95% CI -14·94 to -7·97) greater reduction in systolic blood pressure, and a 0·41 mmol/L (95% CI -0·60 to -0·23) reduction in LDL with the intervention group (both p<0·0001). Change in blood pressure control status (<140 mm Hg) was 69% in the intervention group versus 30% in the control group (p<0·0001). There were no safety concerns with the intervention. INTERPRETATION: A comprehensive model of care led by NPHWs, involving primary care physicians and family that was informed by local context, substantially improved blood pressure control and cardiovascular disease risk. This strategy is effective, pragmatic, and has the potential to substantially reduce cardiovascular disease compared with current strategies that are typically physician based. FUNDING: Canadian Institutes of Health Research; Grand Challenges Canada; Ontario SPOR Support Unit and the Ontario Ministry of Health and Long-Term Care; Boehringer Ingelheim; Department of Management of Non-Communicable Diseases, WHO; and Population Health Research Institute. VIDEO ABSTRACT.
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Doenças Cardiovasculares/prevenção & controle , Participação da Comunidade/métodos , Hipertensão/complicações , Idoso , Colômbia , Feminino , Humanos , Hipertensão/tratamento farmacológico , Hipertensão/prevenção & controle , Hipertensão/terapia , Malásia , Masculino , Comportamento de Redução do RiscoRESUMO
Current global health policy goals include a 25% reduction in premature mortality from noncommunicable diseases by 2025. In this 2-part review, we provide an overview of the current epidemiological data on cardiovascular diseases (CVD), its risk factors, and describe strategies aimed at reducing its burden. In part 1, we examine the global epidemiology of cardiac conditions that have the greatest impact on CVD mortality; the predominant risk factors; and the impact of upstream, societal health determinants (eg, environmental factors, health policy, and health systems) on CVD. Although age-standardized mortality from CVD has decreased in many regions of the world, the absolute number of deaths continues to increase, with the majority now occurring in middle- and low-income countries. It is evident that multiple factors are causally related to CVD, including traditional individual level risk factors (mainly tobacco use, lipids, and elevated blood pressure) and societal level health determinants (eg, health systems, health policies, and barriers to CVD prevention and care). Both individual and societal risk factors vary considerably between different regions of the world and economic settings. However, reliable data to estimate CVD burden are lacking in many regions of the world, which hampers the establishment of nationwide prevention and management strategies. A 25% reduction in premature CVD mortality globally is feasible but will require better implementation of evidence-based policies (particularly tobacco control) and integrated health systems strategies that improve CVD prevention and management. In addition, there is a need for better health information to monitor progress and guide health policy decisions.
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Doenças Cardiovasculares/epidemiologia , Carga Global da Doença , HumanosRESUMO
In this second part of a 2-part series on the global burden of cardiovascular disease, we review the proven, effective approaches to the prevention and treatment of cardiovascular disease. We specifically review the management of acute cardiovascular diseases, including acute coronary syndromes and stroke; the care of cardiovascular disease in the ambulatory setting, including medical strategies for vascular disease, atrial fibrillation, and heart failure; surgical strategies for arterial revascularization, rheumatic and other valvular heart disease, and symptomatic bradyarrhythmia; and approaches to the prevention of cardiovascular disease, including lifestyle factors, blood pressure control, cholesterol-lowering, antithrombotic therapy, and fixed-dose combination therapy. We also discuss cardiovascular disease prevention in diabetes mellitus; digital health interventions; the importance of socioeconomic status and universal health coverage. We review building capacity for conduction cardiovascular intervention through strengthening healthcare systems, priority setting, and the role of cost effectiveness.
Assuntos
Doenças Cardiovasculares/epidemiologia , Carga Global da Doença , Doenças Cardiovasculares/prevenção & controle , Doenças Cardiovasculares/terapia , HumanosRESUMO
BACKGROUND: Cardiovascular disease is the leading cause of death throughout the world, with the majority of deaths occurring in low- and middle-income countries. Despite clear evidence for the benefits of blood pressure reduction and availability of safe and low-cost medications, most individuals are either unaware of their condition or not adequately treated. OBJECTIVE: The primary objective of this study is to evaluate whether a community-based, multifaceted intervention package primarily provided by nonphysician health workers can improve long-term cardiovascular risk in people with hypertension by addressing identified barriers at the patient, health care provider, and health system levels. METHODS/DESIGN: HOPE-4 is a community-based, parallel-group, cluster randomized controlled trial involving 30 communities (1,376 participants) in Colombia and Malaysia. Participants ≥50 years old and with newly diagnosed or poorly controlled hypertension were included. Communities were randomized to usual care or to a multifaceted intervention package that entails (1) detection, treatment, and control of cardiovascular risk factors by nonphysician health workers in the community, who use tablet-based simplified management algorithms, decision support, and counseling programs; (2) free dispensation of combination antihypertensive and cholesterol-lowering medications, supervised by local physicians; and (3) support from a participant-nominated treatment supporter (either a friend or family member). The primary outcome is the change in Framingham Risk Score after 12 months between the intervention and control communities. Secondary outcomes including change in blood pressure, lipid levels, and Interheart Risk Score will be evaluated. SIGNIFICANCE: If successful, the study could serve as a model to develop low-cost, effective, and scalable strategies to reduce cardiovascular risk in people with hypertension.
Assuntos
Anti-Hipertensivos/uso terapêutico , Pressão Sanguínea/fisiologia , Gerenciamento Clínico , Hipertensão/terapia , Avaliação de Resultados em Cuidados de Saúde , Comportamento de Redução do Risco , Causas de Morte/tendências , Colômbia/epidemiologia , Feminino , Seguimentos , Humanos , Hipertensão/mortalidade , Hipertensão/fisiopatologia , Malásia/epidemiologia , Masculino , Pessoa de Meia-Idade , Fatores de TempoRESUMO
OBJECTIVE: The association between body mass index (BMI) and mortality after acute coronary syndromes (ACS) is controversial. The objective of this analysis is to summarize the available evidence of this association and perform meta-analysis using adjusted estimates. METHODS AND RESULTS: Systematic review from MEDLINE and EMBASE through May 2015 was performed. Studies were considered eligible if they described the association between BMI and all-cause mortality after ACS, and those reporting adjusted estimates were included in the meta-analysis. We included 35 articles with 316,455 participants, with overall poor to moderate quality. No study reported that overweight, type-I or type-II obesity was related to an increased risk of mortality compared to normal weight. Pooled adjusted estimates from 18 studies (137,975 participants) showed lower adjusted mortality both overweight (RR: 0.83; 95% CI: 0.75-0.91; p < .001; I2 51%) and obese (RR: 0.79; 95% CI: 0.71-0.88; p < .001; I2 33%) categories when compared to normal weight. Heterogeneity was not explained in pre-specified subgroups analysis. CONCLUSIONS: Increased BMI was associated with increased adjusted survival after ACS when compared to normal BMI. Unexplained heterogeneity and suboptimal quality of studies limit the strength of the results. This seemingly paradoxical finding needs to be confirmed with further research.
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Síndrome Coronariana Aguda/mortalidade , Índice de Massa Corporal , Obesidade/complicações , Síndrome Coronariana Aguda/etiologia , Causas de Morte/tendências , Saúde Global , Humanos , Fatores de Risco , Taxa de Sobrevida/tendênciasAssuntos
Doenças Cardiovasculares , Sistema Cardiovascular , Hipertensão , Humanos , Fatores de RiscoRESUMO
BACKGROUND: The Wellcome Trust, the World Health Organization, and cardiologists have advocated for the idea of a "polypill" containing multiple cardiovascular drugs to be co-formulated into a single pill for over a decade. Some cardiologists have asserted that the drugs commonly considered for inclusion into such a polypill are older and therefore free of patent protection. We tested this assertion. This project was requested by the World Heart Federation (WHF). METHODS, DATA AND MATERIALS: Two cardiologists from the WHF provided a list of 48 cardiovascular drugs for evaluation. We designated the United States and Canada as the base jurisdictions for this patent study. We linked patent data from these countries' national medicine patent registers to patent information in over 96 other countries using Derwent and INPADOC via Thomson Innovation. We expanded our study beyond the aforementioned data linkage through a systematic search of the World Intellectual Property Organization's PatentScope, which was based primarily upon the drugs' active ingredient names. RESULTS: In the United States and Canada, eight of the drugs were only available in the patent-protected, brand name formulation in one or both countries. Another 21 drugs had relevant patents, but generic equivalents were nevertheless available. Only 19 drugs (40 %) appeared entirely post-patent. Broadening the co-formulation searches globally, the overwhelming majority of drugs (40/48) were mentioned in patent applications for cardiovascular drug combinations. CONCLUSION: The assertion that most of these cardiovascular drugs are post-patent is accurate, but only in the sense that many of the original patents on these active ingredients have expired and that generic alternatives are usually available. The landscape of patents covering novel (co-) formulations is far more complex, however. Most research and development for cardiovascular combination medicines are likely to be undertaken by companies whose original patents on the active ingredient will soon expire or have recently expired. Cardiologists looking to accelerate polypill development may consider approaching such companies to partner.
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Doenças Cardiovasculares/tratamento farmacológico , Descoberta de Drogas , Patentes como Assunto , Polimedicação , Canadá , Química Farmacêutica , Medicamentos Genéricos/uso terapêutico , Humanos , Internacionalidade , Estados UnidosRESUMO
BACKGROUND: Discontinuation of guideline-recommended cardiac medications post-ST-elevation myocardial infarction (STEMI) is common and associated with increased mortality. DERLA-STEMI tested an intervention to improve long-term adherence to cardiac medications post-STEMI. METHODS AND RESULTS: Between September 2011 and December 2012, STEMI patients from one health region in Ontario, who underwent an angiogram during their admission and survived to discharge, were cluster randomized (by primary care provider) to intervention or control. The intervention was an automated system of personalized, educational-reminders sent to the patient and their family physician, urging long-term use of secondary-prevention medications. Interventions were mailed at 1, 2, 5, 8, and 11 months after discharge. A total of 852 eligible participants were randomized to intervention (n = 424, 287 clusters) and control (n = 428, 295 clusters); 87% completed a 12-month follow-up. The primary outcome, defined as the proportion of participants taking (persistence) all 4-cardiovascular medication classes (acetylsalicylic acid, angiotensin blockers, statin, and ß-blocker) at 12 months, was 58.4% (intervention) and 58.9% (control; adjusted odds ratio 1.03, 95% CI 0.77-1.36). Medication adherence, as assessed by the Morisky Medication Adherence Score, was statistically significantly better in the intervention group as compared with control (65.3% vs 58.0%, adjusted odds ratio 1.35, 95% CI 1.01-1.81). CONCLUSION: The results suggest suboptimal use of 4 of 4 cardiac medication classes at 12 months. There was no significant difference compared with usual care in the persistence to guideline-recommended medications post-STEMI when participants (and their family physicians) receive repeated postal reminders.
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Fármacos Cardiovasculares/uso terapêutico , Eletrocardiografia , Adesão à Medicação , Infarto do Miocárdio/tratamento farmacológico , Educação de Pacientes como Assunto/métodos , Análise por Conglomerados , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/fisiopatologia , Sistema de Registros , Fatores de TempoRESUMO
Worldwide, there are ~18 million deaths each year from cardiovascular disease and at least 2-3 times as many experience non-fatal cardiovascular events. Numerous evidence-based prevention and management guideline recommendations for cardiovascular disease are available. However, significant gaps between the evidence and its implementation persist ('evidence-practice gap'). There exist 'under-use' gaps with lack of implementation of proven effective strategies and 'over-use' gaps with inappropriate use of strategies with strong evidence against, or insufficient evidence for their effectiveness and safety. To better tackle the global burden of cardiovascular disease (CVD), more effective strategies are needed. We discuss three selected areas where advances in implementation research for CVD could provide improvements. First, a better assessment and understanding of the most important modifiable context-specific barriers to evidence-based care will allow optimal tailoring of interventions to overcome them. Second, novel community intervention strategies from outside current CVD research should be considered, especially for CVD areas where major barriers exist and little progress has been made. Examples of such interventions include cell phone text messaging, non-physician health workers for the delivery community CVD care in areas of need, and low-cost single-pill combination CVD therapy. Third, increasing our understanding of successful implementation and sustainability of improvements is essential for CVD as a widespread chronic disease. Learning how to better implement effective therapies for CVD will have a larger effect on patient outcomes than most single new drugs and is a priority for tackling the global burden of CVD.
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Doenças Cardiovasculares/terapia , Medicina Baseada em Evidências/normas , Previsões , Humanos , Adesão à Medicação , Guias de Prática Clínica como Assunto , Prática Profissional/normas , Pesquisa Translacional Biomédica , Procedimentos DesnecessáriosRESUMO
BACKGROUND: The learning curve for new operators performing ultrasound-guided transfemoral access (TFA) remains uncertain. METHODS: We performed a pooled analysis of the FAUST (Femoral Arterial Access With Ultrasound Trial) and UNIVERSAL (Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures) trials, both multicenter randomized controlled trials of 1:1 ultrasound-guided versus non-ultrasound-guided TFA for coronary procedures. Outcomes included the composite of major bleeding or vascular complications and successful common femoral artery cannulation. Participants were stratified by the operators' accrued case volume. We used adjusted repeated-measurement logistic regression, with random intercepts for operator clustering, for comparison against the non-ultrasound-guided TFA group and to model the learning curve. RESULTS: The FAUST and UNIVERSAL trials randomized a total of 1624 patients, of which 810 were randomized to non-ultrasound-guided TFA and 814 to ultrasound-guided TFA (cases 1-10, 391; 11-20, 183; and >20, 240). Participants who had operators who performed >20 ultrasound-guided TFAs had a decreased risk for the primary end point (5/240 [2.1%] versus 64/810 [7.9%]; adjusted odds ratio, 0.26 [95% CI, 0.09-0.61]) compared with non-ultrasound-guided TFA. Operators who performed >20 ultrasound-guided procedures had increased odds of successfully cannulating the common femoral artery (224/246 [91.1%] versus 327/382 [85.6%]; adjusted odds ratio, 1.76 [95% CI, 1.08-2.89]) compared with non-ultrasound-guided TFA. The learning curve plots demonstrated growing competence with increasing accrued cases. CONCLUSIONS: New operators should perform at least 20 ultrasound-guided TFA to decrease access site complications and increase proper cannulation compared with non-ultrasound-guided TFA. Additional accrued cases may lead to increased proficiency. Training programs should consider these findings in the transradial era.
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Cateterismo Periférico , Competência Clínica , Artéria Femoral , Curva de Aprendizado , Intervenção Coronária Percutânea , Punções , Ensaios Clínicos Controlados Aleatórios como Assunto , Ultrassonografia de Intervenção , Humanos , Artéria Femoral/diagnóstico por imagem , Ultrassonografia de Intervenção/efeitos adversos , Masculino , Feminino , Cateterismo Periférico/efeitos adversos , Pessoa de Meia-Idade , Idoso , Fatores de Risco , Intervenção Coronária Percutânea/educação , Intervenção Coronária Percutânea/efeitos adversos , Resultado do Tratamento , Hemorragia/prevenção & controle , Hemorragia/etiologia , Cateterismo Cardíaco/efeitos adversos , Estudos Multicêntricos como AssuntoRESUMO
BACKGROUND: Whether ultrasound (US)-guided femoral access compared to femoral access without US guidance decreases access site complications in patients receiving a vascular closure device (VCD) is unclear. AIMS: We aimed to compare the safety of VCD in patients undergoing US-guided versus non-US-guided femoral arterial access for coronary procedures. METHODS: We performed a prespecified subgroup analysis of the UNIVERSAL trial, a multicentre randomised controlled trial of 1:1 US-guided femoral access versus non-US-guided femoral access, stratified for planned VCD use, for coronary procedures on a background of fluoroscopic landmarking. The primary endpoint was a composite of major Bleeding Academic Research Consortium 2, 3 or 5 bleeding and vascular complications at 30 days. RESULTS: Of 621 patients, 328 (52.8%) received a VCD (86% ANGIO-SEAL, 14% ProGlide). In patients who received a VCD, those randomised to US-guided femoral access compared to non-US-guided femoral access experienced a reduction in major bleeding or vascular complications (20/170 [11.8%] vs 37/158 [23.4%], odds ratio [OR] 0.44, 95% confidence interval [CI]: 0.23-0.82). In patients who did not receive a VCD, there was no difference between the US- and non-US-guided femoral access groups, respectively (20/141 [14.2%] vs 13/152 [8.6%], OR 1.76, 95% CI: 0.80-4.03; interaction p=0.004). CONCLUSIONS: In patients receiving a VCD after coronary procedures, US-guided femoral access was associated with fewer bleeding and vascular complications compared to femoral access without US guidance. US guidance for femoral access may be particularly beneficial when VCD are used.
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Doenças Cardiovasculares , Dispositivos de Oclusão Vascular , Humanos , Técnicas Hemostáticas/efeitos adversos , Artéria Femoral , Dispositivos de Oclusão Vascular/efeitos adversos , Hemorragia/etiologia , Hemorragia/prevenção & controle , Ultrassonografia de Intervenção , Resultado do TratamentoRESUMO
BACKGROUND: In patients with ST-segment elevation myocardial infarction (STEMI), early initiation of high-intensity statin therapy, regardless of low-density lipoprotein (LDL) cholesterol levels, is the standard of practice worldwide. Aims: We sought to determine the effect of a similar early initiation strategy, using a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor added to the high-intensity statin, on LDL cholesterol in acute STEMI. METHODS: In a randomised, double-blind trial we assigned 68 patients with STEMI undergoing primary percutaneous coronary intervention (PCI) to early treatment with alirocumab 150 mg subcutaneously or to a matching sham control. The first injection was given before primary PCI regardless of the baseline LDL level, then at 2 and 4 weeks. The primary outcome was the percent reduction in direct LDL cholesterol up to 6 weeks, analysed using a linear mixed model. Results: High-intensity statin use was 97% and 100% in the alirocumab and sham-control groups, respectively. At a median of 45 days, the primary outcome of LDL cholesterol decreased by 72.9% with alirocumab (2.97 mmol/L to 0.75 mmol/L) versus 48.1% with the sham control (2.87 mmol/L to 1.30 mmol/L), for a mean between-group difference of -22.3% (p<0.001). More patients achieved the European Society of Cardiology/European Atherosclerosis Society dyslipidaemia guideline target of LDL ≤1.4 mmol/L in the alirocumab group (92.1% vs 56.7%; p<0.001). Within the first 24 hours, LDL declined slightly more rapidly in the alirocumab group than in the sham-control group (-0.01 mmol/L/hour; p=0.03) with similar between-group mean values. Conclusions: In this randomised trial of routine early initiation of PCSK9 inhibitors in patients undergoing primary PCI for STEMI, alirocumab reduced LDL cholesterol by 22% compared with sham control on a background of high-intensity statin therapy. A large trial is needed to determine if this simplified approach followed by long-term therapy improves cardiovascular outcomes in patients with acute STEMI. (ClinicalTrials.gov: NCT03718286).
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Inibidores de Hidroximetilglutaril-CoA Redutases , Hipercolesterolemia , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST , Humanos , Inibidores de PCSK9 , LDL-Colesterol , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Pró-Proteína Convertase 9 , Infarto do Miocárdio com Supradesnível do Segmento ST/tratamento farmacológico , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Método Duplo-Cego , Resultado do TratamentoRESUMO
Background: A significant limitation of femoral artery access for cardiac interventions is the increased risk of vascular complications and bleeding compared to radial access. Ultrasound (US)-guided femoral access may reduce major vascular complications and bleeding. We aim to determine whether routinely using US guidance for femoral arterial access for coronary angiography or intervention will reduce Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding or major vascular complications. Methods: The Ultrasound Guidance for Vascular Access for Cardiac Procedures: A Randomized Trial (UNIVERSAL) is a multicentre, prospective, open-label, randomized trial with blinded outcomes assessment. Patients undergoing coronary angiography with or without intervention via a femoral approach with fluoroscopic guidance will be randomized 1:1 to US-guided femoral access, compared to no US. The primary outcome is the composite of major bleeding based on the BARC 2, 3, or 5 criteria or major vascular complications within 30 days. The trial is designed to have 80% power and a 2-sided alpha level of 5% to detect a 50% relative risk reduction for the primary outcome based on a control event rate of 14%. Results: We completed enrollment on April 29, 2022, with 621 randomized patients. The patients had a mean age of 71 years (25.4% female), with a high rate of comorbidities, as follows: 45% had a prior percutaneous coronary intervention; 57% had previous coronary artery bypass surgery; and 18% had peripheral vascular disease. Conclusions: The UNIVERSAL trial will be one of the largest randomized trials of US-guided femoral access and has the potential to change guidelines and increase US uptake for coronary procedures worldwide.
Introduction: Par rapport à l'abord radial, la limitation importante de l'abord artériel fémoral lors des interventions au cÅur pose un risque accru de complications vasculaires et de saignements. L'abord fémoral guidé par ultrasons (US) peut contribuer à réduire les complications vasculaires majeures et les saignements. Nous avons pour objectif de déterminer si l'utilisation systématique du guidage par US pour l'abord artériel fémoral lors des angiographies ou des interventions coronariennes contribuera à réduire les saignements de type 2, 3 ou 5 selon le B leeding A cademic R esearch C onsortium (BARC) ou les complications vasculaires majeures. Méthodes: L' U ltrasou n d Gu i dance for V ascular Acc e ss fo r Cardiac Procedure s : A Randomized Tria l (UNIVERSAL) est un essai multicentrique, prospectif, ouvert, à répartition aléatoire, réalisé par une évaluation à l'insu des résultats. Les patients subissant une angiographie coronarienne avec ou sans intervention par voie fémorale sous guidage fluoroscopique seront répartis de façon aléatoire 1:1 à l'abord fémoral guidé par US ou sans US. Le principal critère d'évaluation est le critère composite de saignements majeurs de type 2, 3 ou 5 selon les critères du BARC ou de complications vasculaires majeures dans les 30 jours. L'essai est conçu de façon à avoir une puissance de 80 % et un seuil alpha bilatéral de 5 % pour déterminer la réduction du risque relatif de 50 % du critère d'évaluation principal selon un taux d'événements dans le groupe témoin de 14 %. Résultats: Le 29 avril 2022, nous avons terminé le recrutement de 621 patients choisis aléatoirement. Les patients avaient un âge moyen de 71 ans (25,4 % de femmes) et un taux élevé de comorbidités : 45 % avaient déjà subi une intervention coronarienne percutanée, 57 % avaient déjà subi un pontage aorto-coronarien et 18 % avaient une maladie vasculaire périphérique. Conclusions: L'essai UNIVERSAL qui sera l'un des plus vastes essais à répartition aléatoire sur l'abord fémoral guidé par US a le potentiel de faire changer les lignes directrices et de faire augmenter le recours aux US lors des interventions coronariennes dans le monde entier.
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Importance: A significant limitation of femoral artery access for cardiac interventions is the increased risk of vascular complications and bleeding compared with radial access. Strategies to make femoral access safer are needed. Objective: To determine whether routinely using ultrasonography guidance for femoral arterial access for coronary angiography/intervention reduces bleeding or vascular complications. Design, Setting, and Participants: The Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures (UNIVERSAL) randomized clinical trial is a multicenter, prospective, open-label trial of ultrasonography-guided femoral access vs no ultrasonography for coronary angiography or intervention with planned femoral access. Patients were randomized from June 26, 2018, to April 26, 2022. Patients with ST-elevation myocardial infarction were not eligible. Interventions: Ultrasonography guidance vs no ultrasonography guidance for femoral arterial access on a background of fluoroscopic landmarking. Main Outcomes and Measures: The primary composite outcome is the composite of major bleeding based on the Bleeding Academic Research Consortium 2, 3, or 5 criteria or major vascular complications within 30 days. Results: A total of 621 patients were randomized at 2 centers in Canada (mean [SD] age, 71 [10.24] years; 158 [25.4%] female). The primary outcome occurred in 40 of 311 patients (12.9%) in the ultrasonography group vs 50 of 310 patients (16.1%) without ultrasonography (odds ratio, 0.77 [95% CI, 0.49-1.20]; P = .25). The rates of Bleeding Academic Research Consortium 2, 3, or 5 bleeding were 10.0% (31 of 311) vs 10.7% (33 of 310) (odds ratio, 0.93 [95% CI, 0.55-1.56]; P = .78). The rates of major vascular complications were 6.4% (20 of 311) vs 9.4% (29 of 310) (odds ratio, 0.67 [95% CI, 0.37-1.20]; P = .18). Ultrasonography improved first-pass success (277 of 311 [86.6%] vs 222 of 310 [70.0%]; odds ratio, 2.76 [95% CI, 1.85-4.12]; P < .001) and reduced the number of arterial puncture attempts (mean [SD], 1.2 [0.5] vs 1.4 [0.8]; mean difference, -0.26 [95% CI, -0.37 to -0.16]; P < .001) and venipuncture (10 of 311 [3.1%] vs 37 of 310 [11.7%]; odds ratio, 0.24 [95% CI, 0.12-0.50]; P < .001) with similar times to access (mean [SD], 114 [185] vs 129 [206] seconds; mean difference, -15.1 [95% CI, -45.9 to 15.8]; P = .34). All prerandomization prespecified subgroups were consistent with the overall finding. Conclusions and Relevance: In this randomized clinical trial, use of ultrasonography for femoral access did not reduce bleeding or vascular complications. However, ultrasonography did reduce the risk of venipuncture and number of attempts. Larger trials may be required to demonstrate additional potential benefits of ultrasonography-guided access. Trial Registration: ClinicalTrials.gov Identifier: NCT03537118.
Assuntos
Artéria Femoral , Artéria Radial , Humanos , Feminino , Idoso , Masculino , Estudos Prospectivos , Angiografia Coronária/métodos , Fluoroscopia/efeitos adversos , Hemorragia/epidemiologia , Hemorragia/etiologiaRESUMO
BACKGROUND: Anomalous right coronary artery (RCA) from the pulmonary artery (ARCAPA) is a rare congenital heart abnormality with varying clinical presentations, for which multiple imaging modalities are often required for diagnosis. CASE SUMMARY: We present a case of a 76-year-old female presenting with 2 weeks of palpitations and shortness of breath who was found to be in rapid atrial fibrillation (AF) with congestive heart failure. Despite initial medical management, the patient developed cardiogenic shock with anuric renal failure. Emergent right and left heart catheterization did not demonstrate any significant obstructive coronary artery disease but showed severe right ventricular (RV) failure and raised the possibility of an ARCAPA. This diagnosis was further corroborated by findings on a subsequent transoesophageal echocardiogram. In view of profound decline and limited anticipated improvement, the patient ultimately decided to pursue comfort measures in a hospice setting. DISCUSSION: We postulate that the underlying aetiology of our patient's shock state was multifactorial, notably progressive RCA-territory ischaemia and RV failure, sepsis, and new-onset uncontrolled AF. In adults, unrecognized congenital heart disease can uncommonly cause cardiogenic shock. In our case, echocardiography and invasive angiography were integrated for the diagnosis of ARCAPA given the clinical circumstances that limited the use of cardiac computed tomography angiography.
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A survey evaluation was conducted in the division of cardiology at a tertiary care academic centre to assess barriers, facilitators, acceptability, and feasibility of virtual care during the COVID-19 pandemic. Survey responses from 26 health care providers, 45 patients, and 2 caregivers showed that virtual visits (primarily by telephone) were feasible and generally acceptable to most respondents. Key opportunities for improvement included availability of easy-to-use video platforms, space and equipment in clinics, provision of information to patients before visits, and appropriate selection of patients for virtual visits. Results will inform optimization of virtual care during this pandemic and beyond.
Une enquête a été menée dans la division de cardiologie d'un centre universitaire de soins tertiaires pour évaluer les facteurs qui entravent ou facilitent les soins virtuels pendant la pandémie de COVID-19, ainsi que l'acceptabilité et la faisabilité de ces soins. Selon les réponses fournies par 26 dispensateurs de soins de santé, 45 patients et deux aidants sondés, les visites virtuelles (principalement par téléphone) sont réalisables et généralement acceptables pour la plupart des répondants. Les principales possibilités d'amélioration concernent l'offre de plateformes vidéo conviviales, l'espace et l'équipement dans les cliniques, la fourniture de renseignements aux patients avant les visites et la sélection appropriée des patients pour les visites virtuelles. Les résultats permettront d'optimiser les soins virtuels au cours de cette pandémie et par la suite.
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BACKGROUND: Guidelines recommend both acetylsalicylic acid and ticagrelor following acute coronary syndrome (ACS), but appropriate prescription practices lag. We analyzed the impact of government medication approval, national guideline updates, and publicly funded drug coverage plans on P2Y12 inhibitor utilization. METHODS: Accessing provincial databases, we obtained data for elderly ACS patients in Ontario, Canada, between 2008 and 2018. Using interrupted-time series with descriptive statistics and segmented regression analysis, we evaluated types of P2Y12 inhibitors prescribed at discharge and changes to their utilization in patients managed with percutaneous intervention (PCI), coronary artery bypass grafting (CABG) or medically, following national antiplatelet therapy guidelines (by the Canadian Cardiovascular Society), ticagrelor's national approval by Health Canada, and ticagrelor's coverage by a publicly funded medication plan. RESULTS: We included 114,142 patients (49.4%-PCI; mean age 75.71±6.94 and 62.3% male and 7.7%-CABG; mean age 74.11±5.63 and 73.5% male). Among PCI patients, clopidogrel utilization declined monthly after 2010 national guidelines were published (p<0.0001) and within the first month after ticagrelor's national approval by Health Canada (p=0.03). Among PCI patients, ticagrelor utilization increased within the first month (p<0.0001) and continued increasing monthly (p<0.0001) after its coverage by a publicly funded medication plan. Among PCI patients, clopidogrel utilization declined within the first month (p=0.003) and ticagrelor utilization increased monthly (p=0.05) after 2012 CCS guidelines. Among CABG patients, ticagrelor's coverage was associated with a monthly increase in its utilization (p<0.0001). CONCLUSION: National guideline updates and drug coverage by a publicly funded medication plan significantly improved P2Y12 inhibitor utilization. Barriers to appropriate antiplatelet therapy in the surgical population must be explored.