RESUMO
AIMS: The REFLECT I trial investigated the safety and effectiveness of the TriGuard™ HDH (TG) cerebral embolic deflection device in patients undergoing transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: This prospective, multicentre, single-blind, 2:1 randomized (TG vs. no TG) study aimed to enrol up to 375 patients, including up to 90 roll-in patients. The primary combined safety endpoint (VARC-2 defined early safety) at 30 days was compared with a performance goal. The primary efficacy endpoint was a hierarchical composite of (i) all-cause mortality or any stroke at 30 days, (ii) National Institutes of Health Stroke Scale (NIHSS) worsening at 2-5 days or Montreal Cognitive Assessment worsening at 30 days, and (iii) total volume of cerebral ischaemic lesions detected by diffusion-weighted magnetic resonance imaging at 2-5 days. Cumulative scores were compared between treatment groups using the Finkelstein-Schoenfeld method. A total of 258 of the planned, 375 patients (68.8%) were enrolled (54 roll-in and 204 randomized). The primary safety outcome was met compared with the performance goal (21.8% vs. 35%, P < 0.0001). The primary hierarchical efficacy endpoint was not met (mean efficacy score, higher is better: -5.3 ± 99.8 TG vs. 11.8 ± 96.4 control, P = 0.31). Covert central nervous system injury was numerically lower with TG both in-hospital (46.1% vs. 60.3%, P = 0.0698) and at 5 days (61.7 vs. 76.2%, P = 0.054) compared with controls. CONCLUSION: REFLECT I demonstrated that TG cerebral protection during TAVR was safe in comparison with historical TAVR data but did not meet the predefined effectiveness endpoint compared with unprotected TAVR controls.
Assuntos
Estenose da Valva Aórtica , Dispositivos de Proteção Embólica , Substituição da Valva Aórtica Transcateter , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Humanos , Estudos Prospectivos , Desenho de Prótese , Fatores de Risco , Método Simples-Cego , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do TratamentoRESUMO
Dual antiplatelet therapy (DAPT) is key for the prevention of recurrent ischemic events after percutaneous coronary intervention (PCI); however, it increases the risk of bleeding complications. While new generation drug-eluting stents have been shown superior to bare-metal stents after a short DAPT course, the optimal DAPT duration in patients at high bleeding risk (HBR) remains to be determined. TRIAL DESIGN: The XIENCE Short DAPT program consists of three prospective, single-arm studies (XIENCE 90, XIENCE 28 Global and XIENCE 28 USA) investigating 3- or 1-month DAPT durations in HBR patients undergoing PCI with the XIENCE stent. The XIENCE 90 study is being conducted in the US and enrolled 2047 subjects who discontinued DAPT at 3 months if they were free from myocardial infarction (MI), repeat coronary revascularization, stroke, or stent thrombosis. The XIENCE 28 program includes the USA study, enrolling 642 patients in US and Canada, and the Global study, enrolling 963 patients in Europe and Asia. In XIENCE 28, patients were to discontinue DAPT at 1 month post-PCI if event-free. The primary hypothesis for both XIENCE 90 and XIENCE 28 is that a short DAPT regimen will be non-inferior to a conventional DAPT duration with respect to the composite of all-cause death or MI. Patients enrolled in the prospective multicenter post-market XIENCE V USA study will be used as historical control group in a stratified propensity-adjusted analysis. CONCLUSIONS: The XIENCE Short DAPT Program will provide insights into the safety and efficacy of 2 abbreviated DAPT regimens of 3- and 1-month duration in a large cohort of HBR patients undergoing PCI with the XIENCE stent.
Assuntos
Síndrome Coronariana Aguda/tratamento farmacológico , Aspirina/administração & dosagem , Stents Farmacológicos , Everolimo/administração & dosagem , Imunossupressores/administração & dosagem , Infarto do Miocárdio/prevenção & controle , Inibidores da Agregação Plaquetária/administração & dosagem , Antagonistas do Receptor Purinérgico P2Y/administração & dosagem , Aspirina/efeitos adversos , Canadá , Causas de Morte , Esquema de Medicação , Stents Farmacológicos/efeitos adversos , Hemorragia/induzido quimicamente , Hemorragia/prevenção & controle , Humanos , Intervenção Coronária Percutânea , Inibidores da Agregação Plaquetária/efeitos adversos , Estudos Prospectivos , Antagonistas do Receptor Purinérgico P2Y/efeitos adversos , Acidente Vascular Cerebral , Trombose , Estados UnidosRESUMO
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-generation drug-eluting stents have substantially improved outcomes after PCI in the general population; however, DM patients continue to experience high rates of ischemic and bleeding complications. METHODS: DM patients from the pooled XIENCE V registry were divided into high or low bleeding and ischemic risk groups (HBR, LBR, HIR, and LIR) based on established bleeding (age ≥ 75 years; chronic kidney disease; anemia; prior stroke; oral anticoagulation; thrombocytopenia; prior major bleeding) and ischemic (acute coronary syndrome; prior myocardial infarction [MI]; ≥3 stents implanted; ≥3 vessels treated; ≥3 lesions treated; stent length > 60 mm; bifurcation treated with ≥2 stents; chronic total occlusion) risk factors. The primary outcomes were major adverse cardiac events (MACE; cardiac death, MI, or stent thrombosis) and major bleeding at 4-year follow-up. RESULTS: A total of 3,704 DM patients were divided into four groups (21.5% LBR/LIR; 39.0% LBR/HIR; 15.6% HBR/LIR; 23.9% HBR/HIR). Compared with LBR/LIR patients, those at HBR/HIR and HBR/LIR had a significantly higher risk of MACE (HR (95% CI) 2.7 (1.9-3.9) and 2.2 (1.5-3.2), respectively) and major bleeding (2.7 (1.6-4.8) and 2.6 (1.4-4.7), respectively), while LBR/HIR patients did not. CONCLUSIONS: Among DM patients undergoing PCI, presence of bleeding risk factors was associated with a higher risk of both ischemic and bleeding events, whereas commonly used features of ischemic risk did not impact long-term clinical outcomes.
Assuntos
Doença da Artéria Coronariana , Diabetes Mellitus , Stents Farmacológicos , Intervenção Coronária Percutânea , Idoso , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Diabetes Mellitus/epidemiologia , Everolimo , Hemorragia/induzido quimicamente , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação Plaquetária/efeitos adversos , Fatores de Risco , Stents , Resultado do TratamentoRESUMO
Background: Transcatheter aortic valve replacement (TAVR) is an important treatment option for patients with severe symptomatic aortic stenosis. It is important to identify predictors of excellent outcomes (good clinical outcomes, more time spent at home) after TAVR that are potentially amenable to improvement. Objectives: The purpose of the study was to use machine learning to identify potentially modifiable predictors of clinically relevant patient-centered outcomes after TAVR. Methods: We used data from 8,332 TAVR cases (January 2016-December 2021) from 21 hospitals to train random forest models with 57 patient characteristics (demographics, comorbidities, surgical risk score, lab values, health status scores) and care process parameters to predict the end point, a composite of parameters that designated an excellent outcome and included no major complications (in-hospital or at 30 days), post-TAVR length of stay of 1 day or less, discharge to home, no readmission, and alive at 30 days. We used recursive feature elimination with cross-validation and Shapley Additive Explanation feature importance to identify parameters with the highest predictive values. Results: The final random forest model retained 29 predictors (15 patient characteristics and 14 care process components); the area under the curve, sensitivity, and specificity were 0.77, 0.67, and 0.73, respectively. Four potentially modifiable predictors with relatively high Shapley Additive Explanation values were identified: type of anesthesia, direct movement to stepdown unit post-TAVR, time between catheterization and TAVR, and preprocedural length of stay. Conclusions: This study identified four potentially modifiable predictors of excellent outcome after TAVR, suggesting that machine learning combined with hospital-level data can inform modifiable components of care, which could support better delivery of care for patients undergoing TAVR.
RESUMO
Platypnea-orthodeoxia is an uncommon syndrome characterized by positional dyspnea and hypoxia when upright that improves with lying down. We present a 75-year-old man with platypnea-orthodeoxia in the setting of a patent foramen ovale (PFO) and a 2.1 cm highly mobile atrial septal aneurysm with 2 cm bowing. Prior reports have established the use of three-dimensional echocardiography to facilitate percutaneous closure of PFO and atrial septal defect, but its use in patients with platypnea-orthodeoxia is unclear. We document three-dimensional echocardiographic images that accurately estimated PFO defect size and confirmed placement of the occluder device.
Assuntos
Anormalidades Múltiplas/diagnóstico por imagem , Dispneia/diagnóstico por imagem , Ecocardiografia Tridimensional/métodos , Forame Oval Patente/diagnóstico por imagem , Comunicação Interatrial/diagnóstico por imagem , Hipóxia/diagnóstico por imagem , Idoso , Diagnóstico Diferencial , Dispneia/etiologia , Forame Oval Patente/complicações , Comunicação Interatrial/complicações , Humanos , Hipóxia/etiologia , Masculino , PosturaAssuntos
Estenose da Valva Aórtica/cirurgia , Taquicardia Ventricular/etiologia , Substituição da Valva Aórtica Transcateter/efeitos adversos , Idoso de 80 Anos ou mais , Amiodarona/uso terapêutico , Antiarrítmicos/uso terapêutico , Eletrocardiografia , Humanos , Masculino , Complicações Pós-Operatórias/etiologiaRESUMO
BACKGROUND: Stroke and other clinically significant embolic complications are well documented in the early period following transcatheter aortic valve replacement (TAVR). The CAPTIS device is an embolic protection system, designed to provide neurovascular and systemic protection by deflecting debris away from the brain's circulation, capturing the debris and thus avoiding systemic embolisation. AIMS: We aimed to study the safety and feasibility study of the CAPTIS complete cerebral and full-body embolic protection system during TAVR. METHODS: A first-in-human study investigated the safety, feasibility and debris capturing ability of CAPTIS during TAVR. Patients were followed for 30 days. The primary endpoints were device safety and cerebrovascular events at 72 hours. RESULTS: Twenty patients underwent TAVR using balloon-expandable or self-expanding valve systems. CAPTIS was successfully delivered, positioned, deployed, and retrieved in all cases, and TAVR was successfully completed without device-related complications. No cerebrovascular events were observed. High numbers of debris particles were captured in all patients. CONCLUSIONS: The use of the CAPTIS full-body embolic protection system during TAVR was safe, and it captured a substantial number of debris particles. No patient suffered from a cerebrovascular event. A randomised clinical trial is warranted to prove its efficacy.
Assuntos
Estenose da Valva Aórtica , Dispositivos de Proteção Embólica , Embolia , Embolia Intracraniana , Acidente Vascular Cerebral , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/complicações , Desenho de Prótese , Embolia Intracraniana/etiologia , Embolia Intracraniana/prevenção & controle , Resultado do Tratamento , Acidente Vascular Cerebral/etiologia , Embolia/etiologia , Embolia/prevenção & controle , Fatores de RiscoRESUMO
BACKGROUND: The American College of Cardiology/American Heart Association guidelines recommend the assessment and grading of severity of aortic stenosis (AS) as mild, moderate, or severe, per echocardiogram, and recommend aortic valve replacement (AVR) when the AS is severe. OBJECTIVES: The authors sought to describe mortality rates across the entire spectrum of untreated AS from a contemporary, large, real-world database. METHODS: We analyzed a deidentified real-world data set including 1,669,536 echocardiographic reports (1,085,850 patients) from 24 U.S. hospitals (egnite Database, egnite). Patients >18 years of age were classified by diagnosed AS severity. Untreated mortality and treatment rates were examined with Kaplan-Meier (KM) estimates, with results compared using the log-rank test. Multivariate hazards analysis was performed to assess associations with all-cause mortality. RESULTS: Among 595,120 patients with available AS severity assessment, the KM-estimated 4-year unadjusted, untreated, all-cause mortality associated with AS diagnosis of none, mild, mild-to-moderate, moderate, moderate-to-severe, or severe was 13.5% (95% CI: 13.3%-13.7%), 25.0% (95% CI: 23.8%-26.1%), 29.7% (95% CI: 26.8%-32.5%), 33.5% (95% CI: 31.0%-35.8%), 45.7% (95% CI: 37.4%-52.8%), and 44.9% (95% CI: 39.9%-49.6%), respectively. Results were similar when adjusted for informative censoring caused by treatment. KM-estimated 4-year observed treatment rates were 0.2% (95% CI: 0.2%-0.2%), 1.0% (95% CI: 0.7%-1.3%), 4.2% (95% CI: 2.0%-6.3%), 11.4% (95% CI: 9.5%-13.3%), 36.7% (95% CI: 31.8%-41.2%), and 60.7% (95% CI: 58.0%-63.3%), respectively. After adjustment, all degrees of AS severity were associated with increased mortality. CONCLUSIONS: Patients with AS have high mortality risk across all levels of untreated AS severity. Aortic valve replacement rates remain low for patients with severe AS, suggesting that more research is needed to understand barriers to diagnosis and appropriate approach and timing for aortic valve replacement.
Assuntos
Estenose da Valva Aórtica , Implante de Prótese de Valva Cardíaca , Substituição da Valva Aórtica Transcateter , Humanos , Resultado do Tratamento , Implante de Prótese de Valva Cardíaca/métodos , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Ecocardiografia , Índice de Gravidade de Doença , Fatores de RiscoRESUMO
OBJECTIVES: The REFLECT II (Randomized Evaluation of TriGuard 3 Cerebral Embolic Protection After Transcatheter Aortic Valve Implantation) trial was designed to investigate the safety and efficacy of the TriGUARD 3 (TG3) cerebral embolic protection in patients undergoing transcatheter aortic valve replacement. BACKGROUND: Cerebral embolization occurs frequently following transcatheter aortic valve replacement and procedure-related ischemic stroke occurs in 2% to 6% of patients at 30 days. Whether cerebral protection with TriGuard 3 is safe and effective in reducing procedure-related cerebral injury is not known. METHODS: This prospective, multicenter, single-blind, 2:1 randomized (TG3 vs. no TG3) study was designed to enroll up to 345 patients. The primary 30-day safety endpoint (Valve Academic Research Consortium-2 defined) was compared with a performance goal (PG). The primary hierarchical composite efficacy endpoint (including death or stroke at 30 days, National Institutes of Health Stroke Scale score worsening in hospital, and cerebral ischemic lesions on diffusion-weighted magnetic resonance imaging at 2 to 5 days) was compared using the Finkelstein-Schoenfeld method. RESULTS: REFLECT II enrolled 220 of the planned 345 patients (63.8%), including 41 roll-in and 179 randomized patients (121 TG3 and 58 control subjects) at 18 US sites. The sponsor closed the study early after the U.S. Food and Drug Administration recommended enrollment suspension for unblinded safety data review. The trial met its primary safety endpoint compared with the PG (15.9% vs. 34.4% (p < 0.0001). The primary hierarchal efficacy endpoint at 30 days was not met (mean scores [higher is better]: -8.58 TG3 vs. 8.08 control; p = 0.857). A post hoc diffusion-weighted magnetic resonance imaging analysis of per-patient total lesion volume above incremental thresholds showed numeric reductions in total lesion volume >500 mm3 (-9.7%) and >1,000 mm3 (-44.5%) in the TG3 group, which were more pronounced among patients with full TG3 coverage: -51.1% (>500 mm3) and -82.9% (>1,000 mm3). CONCLUSIONS: The REFLECT II trial demonstrated that the TG3 was safe compared with a historical PG but did not meet its pre-specified primary superiority efficacy endpoint.
Assuntos
Estenose da Valva Aórtica , Dispositivos de Proteção Embólica , Acidente Vascular Cerebral , Substituição da Valva Aórtica Transcateter , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Humanos , Estudos Prospectivos , Fatores de Risco , Método Simples-Cego , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do TratamentoRESUMO
BACKGROUND: Damage to the cardiac conduction system requiring permanent pacemaker (PPM) implantation is a known adverse outcome of transcatheter aortic valve replacement (TAVR). A permanent-temporary pacemaker (PTPM) is a device that involves an active-fixation lead attached to an external pulse generator taped to the skin. We reviewed the utility of PTPMs as a temporary bridge measure after TAVR in patients with conduction abnormalities that do not meet conventional criteria for PPM placement. METHODS: Between January 01, 2013 and December 31, 2015, we analyzed 67 patients who received PTPM after TAVR. Baseline demographics, comorbidities, type and size of the valve, pre-TAVR electrocardiograms (ECGs), post-TAVR ECGs at 1 day, 1 month, and 6 months, and pacemaker interrogation results were reviewed for each patient if available. RESULTS: The mean age of patients was 80.5 ± 9.1 years. PTPM were placed for 2.3 ± 2.4 days. Among these patients, 44.8% (n = 30) received a PPM prior to discharge. Male gender (OR 2.84, 95% CI 1.05-7.69, p = 0.05) and an increase in QRS duration post-TAVR (p = 0.01) were associated with PPM placement. Pacemaker interrogation data of 11 patients with PPM revealed that 27% (n = 3) had < 1% V-pacing requirements and < 10% A-pacing requirements. CONCLUSIONS: In post-TAVR patients who develop conduction abnormalities that do not meet conventional PPM implantation indications, PTPM safely provides a time period for further assessment and may prevent unnecessary PPM implantation. Male gender and an increase in QRS duration post-TAVR are associated with PPM implantation. Additionally, some patients may recover from their conduction disturbances and demonstrate low pacemaker utilization.
Assuntos
Estenose da Valva Aórtica/cirurgia , Estimulação Cardíaca Artificial/métodos , Bloqueio Cardíaco/terapia , Marca-Passo Artificial , Complicações Pós-Operatórias/terapia , Substituição da Valva Aórtica Transcateter/métodos , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico por imagem , Estudos de Coortes , Eletrocardiografia/métodos , Desenho de Equipamento , Feminino , Seguimentos , Bloqueio Cardíaco/diagnóstico por imagem , Bloqueio Cardíaco/etiologia , Humanos , Masculino , Complicações Pós-Operatórias/fisiopatologia , Estudos Retrospectivos , Medição de Risco , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do TratamentoRESUMO
The standard of care for patients with acute coronary syndrome is antithrombotic and antiplatelet therapies along with early percutaneous coronary intervention. Because of the limitations of heparin, there has been an interest in direct thrombin inhibitors, such as bivalirudin, which is now the anticoagulant of choice in percutaneous coronary intervention.
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Angioplastia Coronária com Balão/métodos , Anticoagulantes/uso terapêutico , Doença das Coronárias/terapia , Fragmentos de Peptídeos/uso terapêutico , Trombose/prevenção & controle , Doença Aguda , Hirudinas , Humanos , Proteínas Recombinantes/uso terapêuticoRESUMO
Single-vessel, intracoronary infusion of stem cells under stop-flow conditions has proven safe but achieves only limited myocardial coverage. Continuous flow intracoronary delivery to one or more coronary vessels may achieve broader coverage for treating cardiomyopathy, but has not been investigated. Using nonocclusive coronary guiding catheters, we infused allogeneic cardiosphere-derived cells (CDCs) either in a single vessel or sequentially in all three coronary arteries in porcine ischemic cardiomyopathy and used magnetic resonance imaging (MRI) to assess structural and physiological outcomes. Vehicle-infused animals served as controls. Single-vessel stop-flow and continuous-flow intracoronary infusion revealed equivalent effects on scar size and function. Sequential infusion into each of the three major coronary vessels under stop-flow or continuous-flow conditions revealed equal efficacy, but less elevation of necrotic biomarkers with continuous-flow delivery. In addition, multi-vessel delivery resulted in enhanced global and regional tissue function compared to a triple-vessel placebo-treated group. The functional benefits after global cell infusion were accompanied histologically by minimal inflammatory cellular infiltration, attenuated regional fibrosis and enhanced vessel density in the heart. Sequential multi-vessel non-occlusive delivery of CDCs is safe and provides enhanced preservation of left ventricular function and structure. The current findings provide preclinical validation of the delivery method currently undergoing clinical testing in the Dilated cardiomYopathy iNtervention With Allogeneic MyocardIally-regenerative Cells (DYNAMIC) trial of CDCs in heart failure patients.
Assuntos
Mioblastos Cardíacos/citologia , Isquemia Miocárdica/patologia , Isquemia Miocárdica/terapia , Transplante de Células-Tronco , Células-Tronco/citologia , Animais , Cardiomiopatia Hipertrófica/diagnóstico , Cardiomiopatia Hipertrófica/etiologia , Cardiomiopatia Hipertrófica/patologia , Cardiomiopatia Hipertrófica/fisiopatologia , Terapia Baseada em Transplante de Células e Tecidos , Modelos Animais de Doenças , Imuno-Histoquímica , Imageamento por Ressonância Magnética , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/patologia , Infarto do Miocárdio/fisiopatologia , Infarto do Miocárdio/terapia , Isquemia Miocárdica/diagnóstico , Isquemia Miocárdica/mortalidade , Isquemia Miocárdica/fisiopatologia , Fenótipo , Volume Sistólico , Suínos , Remodelação VentricularRESUMO
We assessed aortic regurgitation (AR) severity by utilizing multiple echo-Doppler variables in comparison with AR severity by aortic root angiography. Patients were divided into 3 groups: mild, moderate, and severe. An AR index (ARI) was developed, comprising 5 echocardiographic parameters: ratio of color AR jet height to left ventricular outlet flow diameter, AR signal density from continuous-wave Doppler, pressure half-time, left ventricular end-diastolic diameter, and aortic root diameter. There was a strong correlation between AR severity by angiography and the calculated echo-Doppler ARI (r = 0.84, p = 0.0001). As validated by aortic angiography, the ARI is an accurate reflection of AR severity.
Assuntos
Insuficiência da Valva Aórtica/diagnóstico por imagem , Aortografia/métodos , Cineangiografia/métodos , Ecocardiografia Doppler/métodos , Ecocardiografia Transesofagiana/métodos , Índice de Gravidade de Doença , Adulto , Idoso , Idoso de 80 Anos ou mais , Análise de Variância , Insuficiência da Valva Aórtica/classificação , Aortografia/normas , Cineangiografia/normas , Análise Discriminante , Ecocardiografia Doppler/normas , Ecocardiografia Transesofagiana/normas , Feminino , Hemodinâmica , Humanos , Modelos Lineares , Masculino , Pessoa de Meia-Idade , Variações Dependentes do Observador , Sensibilidade e Especificidade , Método Simples-Cego , Volume Sistólico , Função Ventricular EsquerdaRESUMO
OBJECTIVE: To review the clinical and economic impact of atherothrombosis, the use of antiplatelet therapy for patients with atherothrombosis, and the impact of disease management programs on quality improvement and health care costs. SUMMARY: Atherothrombosis is a new term that describes the formation of a thrombus on an existing atherosclerotic plaque. While simple, this pathophysiologic mechanism underlies a vast array of vascular diseases, including myocardial infarction, ischemia, peripheral arterial disease, vascular death, and many forms of stroke. In fact, atherothrombosis is the leading cause of death worldwide. Treatment approaches include lifestyle modification and the use of pharmacologic agents such as lipid-lowering therapy, antihypertensive agents, hypoglycemic therapy, ACE inhibitors, and beta-blockers. Despite these treatments, studies have indicated that not all patients receive recommended therapies. The continuing upward spiral in health care costs in the United States has spurred numerous initiatives aimed at improving the quality of care while maintaining or reducing costs. Among these approaches to quality improvement are programs that promote adherence to evidence-based clinical data, including published guidelines, and improve the appropriate use of pharmaceuticals. Although expenditures for prescription drugs are rising, they remain a minority of overall health care expenditures, and evidence suggests that improved usage of medications can reduce other direct costs, such as hospitalizations and inpatient care, which may account for a far greater proportion of total costs. CONCLUSION: The utilization of quality improvement techniques and disease management tools can be used to improve the quality of care of patients with atherothrombosis. A key component of this strategy is pharmacologic therapy. The appropriate use of prescription drugs involves several key factors, including the proper selection of the agent based on available clinical evidence, choosing regimens that enhance patient compliance, and sound methodologies to evaluate outcomes. Improvements in the quality of care for patients with atherothrombosis can have a significant impact on the overall quality of health care as well as total costs.
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Arteriosclerose/tratamento farmacológico , Continuidade da Assistência ao Paciente , Gerenciamento Clínico , Programas de Assistência Gerenciada , Inibidores da Agregação Plaquetária/uso terapêutico , Garantia da Qualidade dos Cuidados de Saúde , Trombose/tratamento farmacológico , HumanosRESUMO
Transradial (TR) access is increasingly being used in percutaneous coronary intervention (PCI). However, its role in PCI for ST-segment elevation myocardial infarction remains controversial because of concerns of procedural complexity adversely affecting the promptness of reperfusion. In this study, 150 consecutive patients who underwent PCI for acute ST-segment elevation myocardial infarction over a period of 24 months were prospectively evaluated; 46 had TR access (31%) and 104 (69%) had transfemoral (TF) access. All patients received thienopyridines, aspirin, and heparin per routine management. There were no significant differences between the TR access and TF access groups with respect to age (62.2 ± 11.6 vs 64.7 ± 14.1, p = 0.28), gender (76.1% vs 72.1% men, p = 0.69), or incidence of diabetes (23.9% vs 26.9%, p = 0.84). The TR and TF access groups were comparable with respect to door-to-balloon time (79.2 ± 32.3 vs 86.8 ± 51.8 minutes, p = 0.67) and amount of contrast used (190.5 ± 101.5 vs 172.2 ± 81.7 ml, p = 0.24). Total fluoroscopy time was longer in the TR access group compared to the TF access group (21.7 ± 12.7 vs 14.4 ± 10.4 minutes, p <0.0001). Postprocedural Thrombolysis In Myocardial Infarction (TIMI) grade 3 flow was comparable for the 2 groups (87% for the TF group and 96% for the TR group, p = 0.15). There were no vascular complications in the TR access group compared to the TF access group (0% vs 5.8%, p = 0.18). In conclusion, this single-center observational study shows that TR access for PCI in STEMI is feasible and that it has fewer vascular complications and shorter length of hospital stay than the TF approach.
Assuntos
Angioplastia Coronária com Balão/métodos , Artéria Femoral , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/terapia , Artéria Radial , Idoso , Angioplastia Coronária com Balão/mortalidade , Estudos de Coortes , Angiografia Coronária/métodos , Eletrocardiografia/métodos , Feminino , Fibrinolíticos/uso terapêutico , Seguimentos , Humanos , Modelos Lineares , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/diagnóstico , Intervenção Coronária Percutânea/métodos , Intervenção Coronária Percutânea/mortalidade , Estudos Prospectivos , Medição de Risco , Índice de Gravidade de Doença , Estatísticas não Paramétricas , Análise de Sobrevida , Resultado do TratamentoRESUMO
Clinical trials of stem cell therapy in cardiology are based upon a reasonably solid foundation in animal laboratory research. The most widely used cell source in clinical trials has been the patient's own reconstituted bone marrow cell (BMC) aspirate. Cell sources in human bone marrow include hematopoietic stem cells, mesenchymal progenitor cells, and other cell types with many desirable characteristics. In vitro, they can be induced to become typical sarcomeres with centrally positioned nuclei and abundant mitochondria and to express atrial natriuretic peptide (ANP), brain natriuretic peptide (BNP), and contractile proteins including myosin heavy chain, myosin light chain, and alpha actin. Intracoronary BMC infusion significantly decreases infarct size, increases myocardial perfusion, and improves regional and global cardiac function. Meta-analyses of clinical trials of intracoronary autologous BMC infusion following acute myocardial infarction (MI) report that the mean absolute increase in ejection fraction (EF) is approximately 3% to 4%. This modest improvement in function appears to persist for 1 year. Some trials have shown that clinical events are reduced at 12 months, but others have reported no long-term clinical benefit, and the only 5-year follow-up suggests persistent benefit with decreased mortality, but also little evidence of significant myocardial regeneration in humans. These results have led to efforts to identify better cell sources and to create more conducive myocardial environment for cell proliferation. Among the cell types are skeletal myoblasts, cardiac stem cells, and induced pluripotent stem cells. Environmental modifiers are designed to increase cell survival, persistence, and proliferation.
Assuntos
Transplante de Medula Óssea , Infarto do Miocárdio/terapia , Miocárdio , Regeneração , Transplante de Células-Tronco , Animais , Fator Natriurético Atrial/metabolismo , Células da Medula Óssea/citologia , Células da Medula Óssea/fisiologia , Proliferação de Células , Sobrevivência Celular , Ensaios Clínicos como Assunto , Humanos , Infarto do Miocárdio/fisiopatologia , Miocárdio/metabolismo , Peptídeo Natriurético Encefálico/metabolismo , Células-Tronco/citologia , Células-Tronco/fisiologia , Transplante Autólogo , Função Ventricular Esquerda , Remodelação VentricularRESUMO
OBJECTIVES: To examine the effects of coronary artery vasodilators on coronary arterial distensibility using intravascular coronary ultrasound (IVUS). BACKGROUND: There is limited information on the effect of coronary artery vasodilators on coronary arterial distensibility. METHODS: We studied 20 patients using IVUS. Patients received 100 microg of nitroglycerin (10 patients) or 1 mg of verapamil (10 patients) intravenously. We measured coronary arterial elasticity, the distensibility index, compliance and stiffness index. There were no differences in patient characteristics, lesion characteristics or baseline coronary arterial distensibility between the two groups. RESULTS: Systolic and diastolic blood pressure decreased in both groups (p < 0.05). Maximal coronary arterial cross-sectional luminal area (LA) during the cardiac cycle showed similar dilation in both groups. Nitroglycerin increased maximal LA by 5%, and verapamil increased it by 4% (p < 0.05; p < 0.0001, respectively). However, the degree of dilation of the minimal LA during the cardiac cycle showed a different pattern. Nitroglycerin dilated the minimal LA by 8%, while verapamil dilated the minimal LA by 2% (p < 0.001, p < 0.05, respectively). Consequently, the degree of expansion of LA during each cardiac cycle increased in the verapamil group and decreased in the nitroglycerin group. Thus, nitroglycerin decreased elasticity by 31% (p < 0.001), with no change in compliance, stiffness index or distensibility index. While, verapamil increased elasticity by 37%, the distensibility index by 48% and compliance by 53%, and decreased the stiffness index by 27% (all, p < 0.0001). CONCLUSIONS: While both drugs acutely dilate the coronary arteries, nitroglycerin reduced local coronary arterial distensibility; however, verapamil increased local coronary arterial distensibility.
Assuntos
Bloqueadores dos Canais de Cálcio/farmacologia , Nitroglicerina/farmacologia , Ultrassonografia de Intervenção , Vasodilatadores/farmacologia , Verapamil/farmacologia , Análise de Variância , Bloqueadores dos Canais de Cálcio/uso terapêutico , Complacência (Medida de Distensibilidade)/efeitos dos fármacos , Angiografia Coronária , Diástole/efeitos dos fármacos , Elasticidade/efeitos dos fármacos , Indicadores Básicos de Saúde , Hemodinâmica/efeitos dos fármacos , Humanos , Nitroglicerina/uso terapêutico , Sístole/efeitos dos fármacos , Vasodilatadores/uso terapêutico , Verapamil/uso terapêuticoRESUMO
OBJECTIVES: This study sought to assess the ability of coronary computed tomography angiography (CTA) in identifying complex coronary stenosis morphology before invasive coronary angiography (ICA) and percutaneous coronary intervention (PCI). BACKGROUND: Complexity of stenosis morphology affects PCI success. Whether CTA can detect the entire spectrum of recognized complex stenosis morphologies has not been investigated. METHODS: All nonbypassed, nonstented, >or=2-mm-diameter native coronary arterial segments in 85 consecutive patients who underwent ICA
Assuntos
Angiografia Coronária/métodos , Estenose Coronária/diagnóstico por imagem , Tomografia Computadorizada por Raios X , Idoso , Angioplastia Coronária com Balão , Meios de Contraste , Estenose Coronária/terapia , Reações Falso-Positivas , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Estudos Retrospectivos , Índice de Gravidade de Doença , Fatores de TempoRESUMO
Name and manufacturer: There are two versions of the AdvancedBifurcation Systems (ABS) (ABS, Los Angeles, CA, USA) motherdaughter(MD) platforms: the ABS MD-P (bifurcation stent - provisional),and the ABS MD-Bi (bifurcating stent).Approval status: Not yet approved for clinical use.Platform: Stainless steel.Strut thickness: 105 microns.Coating: Not coated, available in bare metal only.Specific stent design: The MD platform consists of two catheters,a mother catheter (MC) and a daughter catheter (DC). On themother catheter (MC), a mother-daughter stent (MDS) is mountedwhich is positioned as main branch stent. On the DC, a daughterstent (DS) is mounted in cases where the operator prefers to performan upfront two-stent strategy (the MD-Bi) or, in cases wherethe operator prefers the provisional single stenting strategy, there isno stent mounted on the DC (MD-P)...