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INTRODUCTION: Limited data is available on the rates of bleeding and thromboembolic events for patients undergoing low bleeding risk procedures while taking direct oral anticoagulants (DOAC). METHODS: Adults taking DOAC in the Michigan Anticoagulation Quality Improvement Initiative (MAQI2) database who underwent a low bleeding risk procedure between May 2015 and Sep 2019 were included. Thirty-day bleeding (of any severity), thromboembolic events, and death were compared between DOAC temporarily interrupted and continued uninterrupted groups. Adverse event rates were compared using an inverse probability weighting propensity score. RESULTS: There were 820 patients who underwent 1412 low risk procedures. DOAC therapy was temporarily interrupted in 371 (45.2%) patients (601 [42.6%] procedures) and continued uninterrupted in 449 (54.8%) patients (811 [57.4%] procedures). DOAC patients with temporary interruptions were more likely to have diabetes, prior stroke or TIA, prior bleeding, higher CHA2DS2-VASc, and higher modified HAS-BLED scores. DOAC interruption was common for gastrointestinal endoscopy, electrophysiology device implantation, and cardiac catheterization while it was less common for cardioversion, dermatologic procedures, and subcutaneous injection. After propensity score adjustment, bleeding risk was lower in the DOAC temporary interruption group (OR 0.62, 95% CI 0.41-0.95) as compared to the group with continuous DOAC use. Rates of thromboembolic events and death did not differ significantly between the two groups. CONCLUSIONS: DOAC-treated patients undergoing low bleeding risk procedures may experience lower rates of bleeding when DOAC is temporarily interrupted. Prospective studies focused on low bleeding risk procedures are needed to identify the safety DOAC management strategy.
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Fibrilación Atrial , Tromboembolia , Administración Oral , Anticoagulantes/efectos adversos , Fibrilación Atrial/tratamiento farmacológico , Hemorragia/inducido químicamente , Humanos , Estudios Prospectivos , Tromboembolia/prevención & controlRESUMEN
OBJECTIVES: We applied the cardiovascular angiography and interventions (SCAI) shock staging system to patients presenting with acute myocardial infarction and cardiogenic shock (AMI-CS) who were enrolled in the National Cardiogenic Shock Initiative (NCSI). BACKGROUND: The SCAI shock staging system provides a framework for evaluation of patients with CS based on clinical and hemodynamic parameters, but has not been validated in patients with AMI-CS managed with a contemporary treatment algorithm that incorporates early use of Impella. METHODS: Consecutive patients enrolled in NCSI were identified, all of whom were managed with invasive hemodynamic guidance and supported with Impella. Patients were retrospectively categorized into appropriate SCAI shock stages, and outcomes were assessed accordingly. RESULTS: A total of 300 patients were included in the analysis; 182 patients (61%) presented in Stage C shock, 25 (8%) in Stage D, and 93 (31%) in Stage E. Survival to hospital discharge was 76, 76, and 58%, respectively (p = .006). Survival was <20% among patients in Stage E at 24 hr, regardless of baseline stage. There was near perfect agreement in shock staging between two independent clinicians at baseline (kappa = 0.975, 95% CI, 0.95-1.00, p < .001) and at 24 hr (kappa = 0.985, 95% CI, 0.77-1.00, p < .001). CONCLUSION: In patients with AMI-CS enrolled in NCSI, SCAI Shock classification was reproducible, and predicted survival when applied at presentation and at 24 hr.
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Técnicas de Apoyo para la Decisión , Hemodinámica , Infarto del Miocardio sin Elevación del ST/diagnóstico , Infarto del Miocardio con Elevación del ST/diagnóstico , Choque Cardiogénico/diagnóstico , Anciano , Femenino , Corazón Auxiliar , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio sin Elevación del ST/mortalidad , Infarto del Miocardio sin Elevación del ST/fisiopatología , Infarto del Miocardio sin Elevación del ST/terapia , Valor Predictivo de las Pruebas , Pronóstico , Reproducibilidad de los Resultados , Estudios Retrospectivos , Infarto del Miocardio con Elevación del ST/mortalidad , Infarto del Miocardio con Elevación del ST/fisiopatología , Infarto del Miocardio con Elevación del ST/terapia , Índice de Severidad de la Enfermedad , Choque Cardiogénico/mortalidad , Choque Cardiogénico/fisiopatología , Choque Cardiogénico/terapia , Terminología como Asunto , Estados UnidosRESUMEN
BACKGROUND/PURPOSE: General Anesthesia (GA) and conscious sedation (CS) are anesthetics for transfemoral transcatheter aortic valve replacement (TF-TAVR). We compared TF-TAVR outcomes using a novel anesthetic approach with fascia iliaca block (FIB) plus minimal CS (MCS) versus GA. METHODS: This retrospective propensity-matched study included consecutive TF-TAVR patients from January 2013 to December 2017 and dichotomized into FIB-MCS vs. GA. Data were collected from electronic records, Society of Thoracic Surgery (STS) database, and the Transcatheter Valve Therapies (TVT) Registry. Primary endpoints were operating room (OR) time, intensive care unit (ICU) and hospital length of stay (LOS). Secondary endpoints were 30-day, 1-year mortality, quality of life, 30-day re-hospitalization rate, failure of FIB-MCS, and hospital safety outcomes. RESULTS: A total of 304 TF-TAVR patients; FIB-MCS (nâ¯=â¯219) vs. GA (nâ¯=â¯85). Propensity matched 162 patients; FIB-MCS (nâ¯=â¯108) vs. GA (nâ¯=â¯54). FIB-MCS had shorter OR time (197.6⯱â¯56.3 vs. 248.2⯱â¯46.3â¯min, pâ¯<â¯0.001), ICU (67.8⯱â¯71.7 vs. 84.9⯱â¯72.1â¯h, pâ¯=â¯0.004) and hospital LOS (3.2⯱â¯3.7 vs. 5.9⯱â¯3.5 d, pâ¯<â¯0.001). FIB-MCS had lower rate of blood transfusion. FIB-MCA vs. GA 30-day and 1-year mortality were similar in the entire (2.3 vs. 2.4%, pâ¯=â¯1.0; and 8.2 vs. 5.9%, pâ¯=â¯0.49) and matched cohorts (0 vs. 3.7%, pâ¯=â¯0.11 and 7.4 vs. 5.6%, pâ¯=â¯0.75). FIB-MCS were less likely to be re-hospitalized [Odd Ratio: 0.32, CI:0.13-0.76] and 2% to 3% higher KCCQ-12 score. CONCLUSION: TF-TAVR using FIB-MCS is feasible and safe with shorter OR time, ICU and hospital LOS, lower risk of 30-day re-hospitalization, similar 30-day and 1-year mortality with better quality of life at 1-year follow-up.
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Anestesia General , Estenosis de la Válvula Aórtica/cirugía , Cateterismo Periférico , Sedación Consciente , Arteria Femoral , Bloqueo Nervioso , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Anestesia General/efectos adversos , Anestesia General/mortalidad , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/mortalidad , Cateterismo Periférico/efectos adversos , Cateterismo Periférico/mortalidad , Sedación Consciente/efectos adversos , Sedación Consciente/mortalidad , Bases de Datos Factuales , Registros Electrónicos de Salud , Femenino , Humanos , Tiempo de Internación , Masculino , Bloqueo Nervioso/efectos adversos , Bloqueo Nervioso/mortalidad , Tempo Operativo , Readmisión del Paciente , Punciones , Calidad de Vida , Sistema de Registros , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Resultado del TratamientoAsunto(s)
Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Cateterismo Cardíaco , Ecocardiografía Doppler , Hemodinámica , Reemplazo de la Válvula Aórtica Transcatéter , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/fisiopatología , Humanos , Valor Predictivo de las Pruebas , Estudios Retrospectivos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del TratamientoRESUMEN
Importance: It is not clear how often patients receive aspirin (acetylsalicylic acid) while receiving oral anticoagulation with warfarin sodium without a clear therapeutic indication for aspirin, such as a mechanical heart valve replacement, recent percutaneous coronary intervention, or acute coronary syndrome. The clinical outcomes of such patients treated with warfarin and aspirin therapy compared with warfarin monotherapy are not well defined to date. Objective: To evaluate the frequency and outcomes of adding aspirin to warfarin for patients without a clear therapeutic indication for combination therapy. Design, Setting, and Participants: A registry-based cohort study of adults enrolled at 6 anticoagulation clinics in Michigan (January 1, 2010, to December 31, 2017) who were receiving warfarin therapy for atrial fibrillation or venous thromboembolism without documentation of a recent myocardial infarction or history of valve replacement. Exposure: Aspirin use without therapeutic indication. Main Outcomes and Measures: Rates of any bleeding, major bleeding events, emergency department visits, hospitalizations, and thrombotic events at 1, 2, and 3 years. Results: Of the study cohort of 6539 patients (3326 men [50.9%]; mean [SD] age, 66.1 [15.5] years), 2453 patients (37.5%) without a clear therapeutic indication for aspirin were receiving combination warfarin and aspirin therapy. Data from 2 propensity score-matched cohorts of 1844 patients were analyzed (warfarin and aspirin vs warfarin only). At 1 year, patients receiving combination warfarin and aspirin compared with those receiving warfarin only had higher rates of overall bleeding (cumulative incidence, 26.0%; 95% CI, 23.8%-28.3% vs 20.3%; 95% CI, 18.3%-22.3%; P < .001), major bleeding (5.7%; 95% CI, 4.6%-7.1% vs 3.3%; 95% CI, 2.4%-4.3%; P < .001), emergency department visits for bleeding (13.3%; 95% CI, 11.6%-15.1% vs 9.8%; 95% CI, 8.4%-11.4%; P = .001), and hospitalizations for bleeding (8.1%; 6.8%-9.6% vs 5.2%; 4.1%-6.4%; P = .001). Rates of thrombosis were similar, with a 1-year cumulative incidence of 2.3% (95% CI, 1.6%-3.1%) for those receiving combination warfarin and aspirin therapy compared with 2.7% (95% CI, 2.0%-3.6%) for those receiving warfarin alone (P = .40). Similar findings persisted during 3 years of follow-up as well as in sensitivity analyses. Conclusions and Relevance: Compared with warfarin monotherapy, receipt of combination warfarin and aspirin therapy was associated with increased bleeding and similar observed rates of thrombosis. Further research is needed to better stratify which patients may benefit from aspirin while anticoagulated with warfarin for atrial fibrillation or venous thromboembolism; clinicians should be judicious in selecting patients for combination therapy.
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Aspirina/administración & dosificación , Fibrilación Atrial/tratamiento farmacológico , Hemorragia/epidemiología , Sistema de Registros , Medición de Riesgo/métodos , Tromboembolia/prevención & control , Warfarina/administración & dosificación , Anciano , Anticoagulantes/administración & dosificación , Fibrilación Atrial/complicaciones , Relación Dosis-Respuesta a Droga , Quimioterapia Combinada , Femenino , Estudios de Seguimiento , Hemorragia/inducido químicamente , Humanos , Masculino , Persona de Mediana Edad , Inhibidores de Agregación Plaquetaria/administración & dosificación , Estudios Retrospectivos , Factores de Riesgo , Tromboembolia/etiología , Estados Unidos/epidemiologíaRESUMEN
Use of bridging anticoagulation has been shown to be harmful and without benefit in warfarin-treated patients with atrial fibrillation. We performed a quasi-experimental interrupted time series analysis between 2010 and 2017 in the Michigan Anticoagulation Quality Improvement Initiative (MAQI2) collaborative before and after the BRIDGE trial publication (July 2015). Predicted use of bridging at the end of the study period was calculated with and without the effect of the BRIDGE trial after adjustment for patient-level clustering. Predictors of bridging anticoagulation use in the post-BRIDGE trial period were analyzed. In adjusted analyses, the use of bridging anticoagulation declined from a predicted 27.8% (95% confidence interval, 20.5%-35.1%) to 13.6% (95% confidence interval, 9.0%-18.2%) at the end of 2017 (Pâ¯=â¯.001) in response to the BRIDGE trial. Use of bridging anticoagulation declined similarly among atrial fibrillation patients at low risk for stroke (29.0% to 14.4%) and intermediate or high risk for stroke (38.0%-20.3%). Younger age and a prior history of stroke were independent predictors of bridging anticoagulation use following the BRIDGE trial publication. The BRIDGE trial publication is associated with a rapid and significant decline in the use of periprocedural bridging anticoagulation.
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Anticoagulantes/administración & dosificación , Medicina Basada en la Evidencia , Heparina de Bajo-Peso-Molecular/administración & dosificación , Atención Perioperativa , Pautas de la Práctica en Medicina/estadística & datos numéricos , Sistema de Registros , Anciano , Anciano de 80 o más Años , Anticoagulantes/efectos adversos , Femenino , Heparina de Bajo-Peso-Molecular/efectos adversos , Humanos , Masculino , Persona de Mediana Edad , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
OBJECTIVE: The 'Detroit Cardiogenic Shock Initiative' is a single-arm, multicenter study to assess the feasibility of early mechanical circulatory support (MCS) in patients who present with acute myocardial infarction complicated by cardiogenic shock (AMICS) who undergo percutaneous coronary intervention. METHODS: Between July 2016 and February 2017, 4 metro Detroit sites participated in the study. The centers agreed to treat patients with AMICS using a mutually agreed-upon protocol emphasizing invasive hemodynamic monitoring and rapid initiation of MCS. Inclusion and exclusion criteria mimicked those from the 'SHOCK' trial with an additional exclusion criteria being use of intra-aortic balloon pump counter pulsation prior to MCS. RESULTS: A total of 41 consecutive patients were included. Patients had an average age of 65 ± 14 years, 71% were male and 59% of patients were admitted to the hospital in cardiogenic shock. Prior to receiving MCS, 93% of patients were on vasopressors or inotropes, 15% of patients had a witnessed out of hospital cardiac arrest, 27% of patients had an in-hospital cardiac arrest, and 17% were under active cardiopulmonary resuscitation while MCS was being implanted. In accordance to the protocol recommendation, 66% of patients had a MCS device inserted prior to PCI. Right heart catheterization and hemodynamic monitoring was performed in 83% of patients. Door to support times averaged 83 ± 58 minutes and 71% of patients were able to reduce the levels of inotropes and vasopressors within the first 24-hours of their index procedure. Pre-procedure cardiac power output (CPO) was 0.57 W and post-procedure CPO was 0.95 W, a 67% increase (p < 0.001). Survival to explant for the entire cohort was 85% a significant improvement from institutional historical controls (85% vs 51% p < 0.001) and survival to discharge was 76%. CONCLUSION: Centers who adopted a regional shock protocol emphasizing the delivery of early MCS with invasive hemodynamic monitoring can achieve rapid door to support times and can improve survival in patients who present with AMICS. Larger national studies will be needed to further validate this pilot feasibility study.
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Oxigenación por Membrana Extracorpórea/instrumentación , Corazón Auxiliar , Contrapulsador Intraaórtico/instrumentación , Infarto del Miocardio/cirugía , Intervención Coronaria Percutánea , Choque Cardiogénico/terapia , Anciano , Remoción de Dispositivos , Oxigenación por Membrana Extracorpórea/efectos adversos , Oxigenación por Membrana Extracorpórea/mortalidad , Estudios de Factibilidad , Femenino , Hemodinámica , Humanos , Contrapulsador Intraaórtico/efectos adversos , Contrapulsador Intraaórtico/mortalidad , Masculino , Michigan , Persona de Mediana Edad , Infarto del Miocardio/diagnóstico , Infarto del Miocardio/mortalidad , Infarto del Miocardio/fisiopatología , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Proyectos Piloto , Diseño de Prótesis , Recuperación de la Función , Factores de Riesgo , Choque Cardiogénico/diagnóstico , Choque Cardiogénico/mortalidad , Choque Cardiogénico/fisiopatología , Factores de Tiempo , Tiempo de Tratamiento , Resultado del TratamientoAsunto(s)
Corazón Auxiliar , Infarto del Miocardio/terapia , Intervención Coronaria Percutánea , Choque Cardiogénico/terapia , Tiempo de Tratamiento , Adulto , Anciano , Anciano de 80 o más Años , Estudios de Factibilidad , Femenino , Hemodinámica , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/complicaciones , Infarto del Miocardio/diagnóstico , Infarto del Miocardio/fisiopatología , Proyectos Piloto , Datos Preliminares , Diseño de Prótesis , Recuperación de la Función , Choque Cardiogénico/diagnóstico , Choque Cardiogénico/etiología , Choque Cardiogénico/fisiopatología , Factores de Tiempo , Resultado del Tratamiento , Estados UnidosAsunto(s)
Apéndice Atrial/diagnóstico por imagen , Fibrilación Atrial/cirugía , Procedimientos Quirúrgicos Cardíacos/métodos , Ecocardiografía Transesofágica/métodos , Imagenología Tridimensional , Tomografía Computarizada Multidetector/métodos , Accidente Cerebrovascular/prevención & control , Anciano de 80 o más Años , Apéndice Atrial/cirugía , Fibrilación Atrial/complicaciones , Fibrilación Atrial/diagnóstico , Humanos , Masculino , Periodo Preoperatorio , Impresión Tridimensional , Accidente Cerebrovascular/etiologíaRESUMEN
Clinical factors and patient preferences are important for selecting oral anticoagulants for venous thromboembolism (VTE) and atrial fibrillation (AF). The relative association of sociodemographic factors with anticoagulant use is unknown. We evaluated a prospective cohort to compare sociodemographic variables in patients who continued on warfarin for AF or VTE to those who transitioned to 1 of the direct oral anticoagulants (DOACs). Adult patients, newly started on warfarin, were enrolled through 6 anticoagulation clinics across Michigan. Of 8468 patients, 53.3% had AF, 45.6% had VTE, and 1.1% had both. Of these, 696 (8.2%) switched from warfarin to a DOAC. There were no significant differences between switchers and nonswitchers for percentage of time with a therapeutic international normalized ratio on warfarin, urban-rural residence status, or health insurance. Switchers were more often white (83.3% vs 77.7%; P < .001), partnered (67.3% vs 59.2%; P < .001), or resided in a zip code with a higher median household income (P < .001). The results show that sociodemographic factors, such as race, partnered status, and income are associated with a patient's likelihood of switching to a DOAC vs remaining on warfarin therapy. Although clinical factors predominate, the reason for, and impact of, these observed variations in care requires further investigation.
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AIMS: We report the use of a novel endovascular approach using chemical neurolysis, via periadventitial injection of dehydrated ethanol (EtOH) to perform renal artery denervation. METHODS AND RESULTS: A novel, three-needle delivery device was introduced into the renal arteries of adult swine using fluoroscopic guidance. EtOH was injected bilaterally with one injection per artery, via the three needles into the adventitial and periadventitial space, using EtOH doses 0.15 ml/artery; n=3, 0.30 ml/artery; n=3, and 0.60 ml/artery; n=3, with saline injection as a sham control (0.4 ml/artery; n=3), and naive subjects (n=7) as a true negative control. The renal parenchymal norepinephrine (NE) concentration at two-week follow-up was the primary efficacy endpoint. The mean renal NE reduction was 54%, 78% and 88% at doses of 0.15 ml, 0.30 ml and 0.60 ml, respectively (p<0.0001 vs. controls). Histological examination revealed marked, and deep, circumferential renal nerve injury at depths of 2-8 mm from the intimal surface. There was no evidence of device-related or EtOH-induced injury to the intimal layers. In some samples at the higher EtOH doses, there was focal loss of smooth muscle cells in the outer media. Angiography at 45 days demonstrated normal appearing renal arteries with no detectable stenoses (n=8). CONCLUSIONS: Circumferential adventitial delivery of very low doses of EtOH may be a promising alternative to energy-based systems to achieve dose-dependent, and predictable renal denervation. Further study is warranted.
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Técnicas de Ablación , Procedimientos Endovasculares , Etanol/administración & dosificación , Riñón/irrigación sanguínea , Riñón/inervación , Simpatectomía Química/métodos , Animales , Relación Dosis-Respuesta a Droga , Riñón/metabolismo , Riñón/patología , Modelos Animales , Norepinefrina/metabolismo , Arteria Renal , Porcinos , Factores de TiempoAsunto(s)
Cardiomiopatías/diagnóstico , Divertículo/diagnóstico , Aneurisma Cardíaco/diagnóstico , Cardiomiopatías/diagnóstico por imagen , Angiografía Coronaria , Divertículo/complicaciones , Divertículo/diagnóstico por imagen , Aneurisma Cardíaco/complicaciones , Aneurisma Cardíaco/diagnóstico por imagen , Ventrículos Cardíacos/diagnóstico por imagen , Humanos , Imagen por Resonancia Magnética , Masculino , Persona de Mediana EdadRESUMEN
The diagnosis of an acute coronary syndrome associated with heparin-induced thrombocytopenia is an increasingly recognized complication of heparin exposure. We describe a case of an acute myocardial infarction 2 weeks after elective aortobifemoral bypass surgery, subsequent subacute coronary artery stent thrombosis, and the treatment strategies available.
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Anticoagulantes/efectos adversos , Vasos Coronarios , Heparina/efectos adversos , Stents/efectos adversos , Trombocitopenia/inducido químicamente , Trombocitopenia/complicaciones , Trombosis/etiología , Anticoagulantes/uso terapéutico , Femenino , Heparina/uso terapéutico , Humanos , Persona de Mediana Edad , Procedimientos Quirúrgicos VascularesRESUMEN
Assessment of coronary lesion length using visual estimation or quantitative coronary angiography can be unreliable. We tested the accuracy of a new handheld caliper device to measure lesion length in a bench-top model and in eight patients undergoing percutaneous coronary intervention (PCI). Caliper-derived length measurements were compared to the known reference distance in the bench-top model and visual or intravascular ultrasound (IVUS)-derived measurements in vivo. In the coronary model, caliper-derived measurements were accurate and correlated well with known reference distances regardless of the angiographic projection. During PCI, there was a poor correlation between the best visual estimate of length and IVUS-derived measurements. In contrast, caliper-derived measurements correlated closely with IVUS-derived measurements. This handheld caliper provides a simple and accurate method of assessing intracoronary lesion length and may be particularly useful during coronary stenting and when adjunctive brachytherapy is performed.
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Angioplastia Coronaria con Balón , Angiografía Coronaria/instrumentación , Enfermedad Coronaria/patología , Vasos Coronarios/patología , Radiografía Intervencional/instrumentación , Angiografía Coronaria/métodos , Enfermedad Coronaria/diagnóstico por imagen , Enfermedad Coronaria/terapia , Humanos , Variaciones Dependientes del Observador , Radiografía Intervencional/métodosRESUMEN
Preview Medical clearance for patients who need surgery is commonly requested of primary care physicians. A focused evaluation of the cardiovascular and other major body systems is the key to assessing preoperative risk. Which diagnostic tools and laboratory tests are most helpful? And which findings are most significant? The authors answer these questions and suggest ways primary care doctors can help minimize complications in the perioperative period.