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2.
ESC Heart Fail ; 11(1): 390-399, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-38011913

RESUMEN

AIMS: The multi-systemic effects of heart failure (HF) resemble the spread observed during cancer. We propose a new score, named HLM, analogous to the TNM classification used in oncology, to assess the prognosis of HF. HLM refers to H: heart damage, L: lung involvement, and M: systemic multiorgan involvement. The aim was to compare the HLM score to the conventional New York Heart Association (NYHA) classification, American College of Cardiology/American Heart Association (ACC/AHA) stages, and left ventricular ejection fraction (LVEF), to assess the most accurate prognostic tool for HF patients. METHODS AND RESULTS: We performed a multicentre, observational, prospective study of consecutive patients admitted for HF. Heart, lung, and other organ function parameters were collected. Each patient was classified according to the HLM score, NYHA classification, ACC/AHA stages, and LVEF assessed by transthoracic echocardiography. The follow-up period was 12 months. The primary endpoint was a composite of all-cause death and rehospitalization due to HF. A total of 1720 patients who completed the 12 month follow-up period have been enrolled in the study. 520 (30.2%) patients experienced the composite endpoint of all-cause death and rehospitalization due to HF. 540 (31.4%) patients were female. The mean age of the study population was 70.5 ± 12.9. The mean LVEF at admission was 42.5 ± 13%. Regarding the population distribution across the spectrum of HLM score stages, 373 (21.7%) patients were included in the HLM-1, 507 (29.5%) in the HLM-2, 587 (34.1%) in the HLM-3, and 253 (14.7%) in the HLM-4. HLM was the most accurate score to predict the primary endpoint at 12 months. The area under the receiver operating characteristic curve (AUC) was greater for the HLM score compared with the NYHA classification, ACC/AHA stages, or LVEF, regarding the composite endpoint (HLM = 0.645; NYHA = 0.580; ACC/AHA = 0.589; LVEF = 0.572). The AUC of the HLM score was significantly better compared with the LVEF (P = 0.002), ACC/AHA (P = 0.029), and NYHA (P = 0.009) AUC. CONCLUSIONS: The HLM score has a greater prognostic power compared with the NYHA classification, ACC/AHA stages, and LVEF assessed by transthoracic echocardiography in terms of the composite endpoint of all-cause death and rehospitalization due to HF at 12 months of follow-up.


Asunto(s)
Insuficiencia Cardíaca , Neoplasias , Femenino , Humanos , Masculino , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/epidemiología , Pronóstico , Estudios Prospectivos , Volumen Sistólico , Estados Unidos , Función Ventricular Izquierda , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años
3.
Am J Med Qual ; 38(1): 29-36, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-36579962

RESUMEN

Financial incentives are often used to encourage and reward clinicians for achieving specific outcomes; however, there is limited data on their effectiveness. This study evaluates the impact of NewYork Quality Care's Clinician Incentive Program on improving quality measure performance over 4 years. Clinicians including primary care physicians and specialists actively opted-in to an incentive program where their quality performance was evaluated and rewarded biannually. Using Medicare Shared Savings Program data extracted for quality measures (2016-2019), this study analyzes quality measure performance between clinicians who opted-in to the program compared to those who did not. Additional analysis was performed comparing primary care clinician and specialist performance. The analysis revealed that clinicians in the incentive program significantly outperform (P < 0.05) clinicians who chose not to join the program in 6 of the 7 quality measures. In addition, the program helped facilitate discussions with clinicians more broadly in population health efforts.


Asunto(s)
Organizaciones Responsables por la Atención , Medicare , Anciano , Humanos , Estados Unidos , Indicadores de Calidad de la Atención de Salud , Motivación , Ahorro de Costo , Reembolso de Incentivo
5.
Am J Med Qual ; 36(3): 139-144, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33941721

RESUMEN

The coronavirus pandemic catalyzed a digital health transformation, placing renewed focus on using remote monitoring technologies to care for patients outside of hospitals. At NewYork-Presbyterian, the authors expanded remote monitoring infrastructure and developed a COVID-19 Hypoxia Monitoring program-a critical means through which discharged COVID-19 patients were followed and assessed, enabling the organization to maximize inpatient capacity at a time of acute bed shortage. The pandemic tested existing remote monitoring efforts, revealing numerous operating challenges including device management, centralized escalation protocols, and health equity concerns. The continuation of these programs required addressing these concerns while expanding monitoring efforts in ambulatory and transitions of care settings. Building on these experiences, this article offers insights and strategies for implementing remote monitoring programs at scale and improving the sustainability of these efforts. As virtual care becomes a patient expectation, the authors hope hospitals recognize the promise that remote monitoring holds in reenvisioning health care delivery.


Asunto(s)
COVID-19/terapia , Continuidad de la Atención al Paciente/organización & administración , Monitoreo Fisiológico/estadística & datos numéricos , Telemedicina/organización & administración , Sistemas de Apoyo a Decisiones Clínicas , Humanos , Monitoreo Ambulatorio/estadística & datos numéricos , Ciudad de Nueva York , Evaluación de Resultado en la Atención de Salud
6.
JAMA Cardiol ; 3(1): 77-83, 2018 01 01.
Artículo en Inglés | MEDLINE | ID: mdl-29167886

RESUMEN

Importance: The US health care system faces an unsustainable trajectory of high costs and inconsistent outcomes. The fee-for-service payment model has contributed to inefficiency, and new payment methods are a promising approach to improving value. Health reforms are needed to increase patient access, reduce costs, and improve health care quality, and the landmark Medicare Access and CHIP Reauthorization Act presents a roadmap for reform. The product of a collaboration between primary care and cardiology clinicians, this review describes a conceptual approach to delivery and payment reforms that aim to better support primary care-cardiology comanagement of chronic cardiovascular disease (CVD). Observations: Few existing alternative payment models specifically address long-term management of CVD. Primary care medical homes and accountable care organizations come closest, but both emphasize primary care, and cardiologists have often not been well engaged. A collaborative care framework should articulate distinct roles and responsibilities for primary care and cardiology in CVD comanagement. Finally, a series of payment models aim to better support clinicians in providing accountable, seamless, and patient-centered cardiac care. Conclusions & Relevance: Clinical leadership is essential during this time of change in the health care system. Patients often struggle to navigate a fragmented and expensive system, whereas clinicians often practice with incomplete information about tests, treatments, and recommendations by their colleagues. The payment models described in this review offer an opportunity to create more satisfying approaches to patient care while improving value. These models have potential to support more effective coordination and to facilitate broader health care system transformation.


Asunto(s)
Cardiología/organización & administración , Relaciones Interprofesionales , Atención Primaria de Salud/organización & administración , Cardiología/economía , Enfermedades Cardiovasculares/economía , Enfermedades Cardiovasculares/terapia , Humanos , Colaboración Intersectorial , Atención Dirigida al Paciente/economía , Relaciones Médico-Paciente , Administración de la Práctica Médica , Atención Primaria de Salud/economía , Mecanismo de Reembolso
7.
JAMA Cardiol ; 2(2): 210-217, 2017 02 01.
Artículo en Inglés | MEDLINE | ID: mdl-27851858

RESUMEN

Importance: Recent health care reforms aim to increase patient access, reduce costs, and improve health care quality as payers turn to payment reform for greater value. Cardiologists need to understand emerging payment models to succeed in the evolving payment landscape. We review existing payment and delivery reforms that affect cardiologists, present 4 emerging examples, and consider their implications for clinical practice. Observations: Public and commercial payers have recently implemented payment reforms and new models are evolving. Most cardiology models are modified fee-for-service or address procedural or episodic care, but population models are also emerging. Although there is widespread agreement that payment reform is needed, existing programs have significant limitations and the adoption of new programs has been slow. New payment reforms address some of these problems, but many details remain undefined. Conclusions and Relevance: Early payment reforms were voluntary and cardiologists' participation is variable. However, conventional fee-for-service will become less viable, and enrollment in new payment models will be unavoidable. Early participation in new payment models will allow clinicians to develop expertise in new care pathways during a period of relatively lower risk.


Asunto(s)
Cardiología/economía , Planes de Aranceles por Servicios/economía , Reforma de la Atención de Salud , Calidad de la Atención de Salud , Humanos
10.
J Am Coll Cardiol ; 65(19): 2118-36, 2015 May 19.
Artículo en Inglés | MEDLINE | ID: mdl-25975476

RESUMEN

The mission of the American College of Cardiology is "to transform cardiovascular care and improve heart health." Cardiovascular team-based care is a paradigm for practice that can transform care, improve heart health, and help meet the demands of the future. One strategic goal of the College is to help members successfully transition their clinical practices to the future, with all its complexity, challenges, and opportunities. The ACC's strategic plan is aligned with the triple aim of improved care, improved population health, and lower costs per capita. The traditional understanding of quality, access, and cost is that you cannot improve one component without diminishing the others. With cardiovascular team-based care, it is possible to achieve the triple aim of improving quality, access, and cost simultaneously to also improve cardiovascular health. Striving to serve the best interests of patients is the true north of our guiding principles. Cardiovascular team-based care is a model that can improve care coordination and communication and allow each team member to focus more on the quality of care. In addition, the cardiovascular team-based care model increases access to cardiovascular care and allows expansion of services to populations and geographic areas that are currently underserved. This document will increase awareness of the important components of cardiovascular team-based care and create an opportunity for more discussion about the most creative and effective means of implementing it. We hope that this document will stimulate further discussions and activities within the ACC and beyond about team-based care. We have identified areas that need improvement, specifically in APP education and state regulation. The document encourages the exploration of collaborative care models that should enable team members to optimize their education, training, experience, and talent. Improved team leadership, coordination, collaboration, engagement, and efficiency will enable the delivery of higher-value care to the betterment of our patients and society.


Asunto(s)
Cardiología/normas , Enfermedades Cardiovasculares/terapia , Personal de Salud/normas , Política de Salud , Grupo de Atención al Paciente/normas , Guías de Práctica Clínica como Asunto , Sociedades Médicas , Conducta Cooperativa , Humanos
11.
J Am Coll Cardiol ; 64(21): 2183-92, 2014 Dec 02.
Artículo en Inglés | MEDLINE | ID: mdl-25447259

RESUMEN

BACKGROUND: In a significant update, the 2013 American College of Cardiology/American Heart Association (ACC/AHA) cholesterol guidelines recommend fixed-dose statin therapy for those at risk and do not recommend nonstatin therapies or treatment to target low-density lipoprotein cholesterol (LDL-C) levels, limiting the need for repeated LDL-C testing. OBJECTIVES: The goal of this study was to examine the impact of the 2013 ACC/AHA cholesterol guidelines on current U.S. cardiovascular practice. METHODS: Using the NCDR PINNACLE (National Cardiovascular Data Registry Practice Innovation and Clinical Excellence) registry data from 2008 to 2012, we assessed current practice patterns as a function of the 2013 cholesterol guidelines. Lipid-lowering therapies and LDL-C testing patterns by patient risk group (atherosclerotic cardiovascular disease [ASCVD], diabetes, LDL-C ≥190 mg/dl, or an estimated 10-year ASCVD risk ≥7.5%) were described. RESULTS: Among a cohort of 1,174,545 patients, 1,129,205 (96.1%) were statin-eligible (91.2% ASCVD, 6.6% diabetes, 0.3% off-treatment LDL-C ≥190 mg/dl, 1.9% estimated 10-year ASCVD risk ≥7.5%). There were 377,311 patients (32.4%) not receiving statin therapy and 259,143 (22.6%) receiving nonstatin therapies. During the study period, 20.8% of patients had 2 or more LDL-C assessments, and 7.0% had more than 4. CONCLUSIONS: In U.S. cardiovascular practices, 32.4% of statin-eligible patients, as defined by the 2013 ACC/AHA cholesterol guidelines, were not currently receiving statins. In addition, 22.6% were receiving nonstatin lipid-lowering therapies and 20.8% had repeated LDL-C testing. Achieving concordance with the new cholesterol guidelines in patients treated in U.S. cardiovascular practices would result in significant increases in statin use, as well as significant reductions in nonstatin therapies and laboratory testing.


Asunto(s)
LDL-Colesterol/sangre , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Hipercolesterolemia/tratamiento farmacológico , Guías de Práctica Clínica como Asunto , Adulto , Anciano , Enfermedad de la Arteria Coronaria/tratamiento farmacológico , Enfermedad de la Arteria Coronaria/epidemiología , Enfermedad de la Arteria Coronaria/prevención & control , Diabetes Mellitus/epidemiología , Femenino , Humanos , Hipercolesterolemia/sangre , Masculino , Persona de Mediana Edad , Sistema de Registros , Medición de Riesgo , Estados Unidos/epidemiología
12.
J Am Coll Cardiol ; 62(21): 1931-1947, 2013 Nov 19.
Artículo en Inglés | MEDLINE | ID: mdl-24036027

RESUMEN

OBJECTIVES: The aim of this report was to characterize the patients, participating centers, and measures of quality of care and outcomes for 5 NCDR (National Cardiovascular Data Registry) programs: 1) ACTION (Acute Coronary Treatment and Intervention Outcomes Network) Registry-GWTG (Get With The Guidelines) for acute coronary syndromes; 2) CathPCI Registry for coronary angiography and percutaneous coronary intervention; 3) CARE (Carotid Artery Revascularization and Endarterectomy) Registry for carotid revascularization; 4) ICD Registry for implantable cardioverter defibrillators; and the 5) PINNACLE (Practice INNovation And CLinical Excellence) Registry for outpatients with cardiovascular disease (CVD). BACKGROUND: CVD is a leading cause of death and disability in the United States. The quality of care for patients with CVD is suboptimal. National registry programs, such as NCDR, permit assessments of the quality of care and outcomes for broad populations of patients with CVD. METHODS: For the year 2011, we assessed for each of the 5 NCDR programs: 1) demographic and clinical characteristics of enrolled patients; 2) key characteristics of participating centers; 3) measures of processes of care; and 4) patient outcomes. For selected variables, we assessed trends over time. RESULTS: In 2011 ACTION Registry-GWTG enrolled 119,967 patients in 567 hospitals; CathPCI enrolled 632,557 patients in 1,337 hospitals; CARE enrolled 4,934 patients in 130 hospitals; ICD enrolled 139,991 patients in 1,435 hospitals; and PINNACLE enrolled 249,198 patients (1,436,328 individual encounters) in 74 practices (1,222 individual providers). Data on performance metrics and outcomes, in some cases risk-adjusted with validated NCDR models, are presented. CONCLUSIONS: The NCDR provides a unique opportunity to understand the characteristics of large populations of patients with CVD, the centers that provide their care, quality of care provided, and important patient outcomes.


Asunto(s)
Enfermedades Cardiovasculares/cirugía , Adhesión a Directriz , Intervención Coronaria Percutánea , Sistema de Registros , Humanos , Factores de Riesgo , Estados Unidos
13.
J Surg Res ; 159(1): 595-602, 2010 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-20194053

RESUMEN

BACKGROUND: Carotid endarterectomy (CEA) is one of the most frequently performed surgical procedures in the United States. Traditionally, this procedure has been performed by surgeons in at least four specialties. The purpose of this study was to examine the effect of surgeon specialty on the long-term outcomes of CEA among patients receiving the procedure in Pennsylvania. MATERIALS AND METHODS: Data included 17,635 patient admissions for CEA performed between 1995 and 1997, and patient readmission data for the 5-y follow-up period ending in 2002. Five-y outcomes for these patients were compared between vascular, cardiothoracic, general, and neurosurgeons. The primary outcome measures were mortality, stroke, combined stroke and mortality, transient ischemic attack (TIA), and re-occlusion of the ipsilateral artery. Secondary outcomes measured were length of stay and total charges. RESULTS: Using general surgeon as the reference group, and controlling for age, race, severity, and admission type, we found no significant difference across surgical specialties in overall mortality at 5 y post-CEA. Patients treated by vascular surgeons were found to have significantly fewer (P=0.012) strokes and significantly lower re-occlusion rate (P=0.021) at 5 y compared with patients of general surgeons. Patients treated by vascular surgeons also had significantly shorter hospital stay (P<0.0001) but significantly higher charges (P<0.0001) relative to general surgeons. CONCLUSIONS: These results suggest that there are significant differences in outcomes following carotid endarterectomy according to surgeon training. Additional research is needed to explore differences across specialties that may be driving outcomes and to explore the role of surgeon volume at the profession level and cross-volume effects on CEA outcomes.


Asunto(s)
Endarterectomía Carotidea/estadística & datos numéricos , Ataque Isquémico Transitorio/epidemiología , Complicaciones Posoperatorias/epidemiología , Especialidades Quirúrgicas/estadística & datos numéricos , Accidente Cerebrovascular/epidemiología , Anciano , Femenino , Estudios de Seguimiento , Humanos , Ataque Isquémico Transitorio/prevención & control , Masculino , Pennsylvania/epidemiología , Accidente Cerebrovascular/prevención & control , Resultado del Tratamiento
14.
Am J Cardiol ; 105(5): 745-52, 2010 Mar 01.
Artículo en Inglés | MEDLINE | ID: mdl-20185027

RESUMEN

This report presents data describing a large cohort of closed cardiovascular medical professional liability (MPL) claims. The Physician Insurers Association of America established a registry of closed MPL claims in 1985. This registry contains data describing 230,624 closed claims for 28 medical specialties through 2007. The registry is maintained to support educational programs designed to improve the quality of care and to reduce patient injury and MPL claims. In this report, descriptive techniques are used to present summary information for the medical cardiovascular claims in the registry. Of 230,624 closed claims, 4,248 (1.8%) involved cardiovascular medical physicians. Of the 4,248 closed cardiovascular medical claims, 770 (18%) resulted in indemnity payments, and the average indemnity payment was $248,291. In the entire database, 30% of closed claims were paid, and the average indemnity payment was $204,268. The most common allegation among cardiovascular closed claims was diagnostic error, and the most prevalent diagnosis was coronary atherosclerosis. Claims involving cardiac catheterization and coronary angioplasty represented 12% and 7% of the cardiovascular closed claims. Aortic aneurysms and dissections, although relatively infrequent as clinical events, represent a substantial MPL risk because of the high percentage of paid claims (30%) and the very high average indemnity payment of $417,298. In conclusion, MPL issues are common and are important to all practicing cardiologists. Detailed knowledge of risks associated with liability claims should assist practicing cardiologists in improving the quality of care, reducing patient injury, and reducing the incidence of claims.


Asunto(s)
Enfermedades Cardiovasculares , Formulario de Reclamación de Seguro/estadística & datos numéricos , Seguro de Responsabilidad Civil/estadística & datos numéricos , Responsabilidad Legal/economía , Errores Médicos/estadística & datos numéricos , Sistema de Registros , Enfermedades Cardiovasculares/diagnóstico , Enfermedades Cardiovasculares/epidemiología , Enfermedades Cardiovasculares/terapia , Estudios de Cohortes , Compensación y Reparación/legislación & jurisprudencia , Humanos , Formulario de Reclamación de Seguro/economía , Formulario de Reclamación de Seguro/legislación & jurisprudencia , Seguro de Responsabilidad Civil/economía , Seguro de Responsabilidad Civil/legislación & jurisprudencia , Errores Médicos/economía , Errores Médicos/legislación & jurisprudencia , Medicina/estadística & datos numéricos , Estados Unidos/epidemiología
15.
JACC Cardiovasc Interv ; 2(7): 594-600, 2009 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-19628179

RESUMEN

OBJECTIVES: The aim of this study was to determine 5-year clinical status for patients treated with percutaneous left atrial appendage transcatheter occlusion with the PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) system. BACKGROUND: Anticoagulation reduces thromboembolism among patients with nonvalvular atrial fibrillation (AF). However, warfarin is a challenging medication due to risks of inadequate anticoagulation and bleeding. Thus, PLAATO was evaluated as a treatment strategy for nonwarfarin candidate patients with AF at high risk for stroke. METHODS: Sixty-four patients with permanent or paroxysmal AF participated in this observational, multicenter prospective study. Primary end points were: new major or minor stroke, cardiac or neurological death, myocardial infarction, or requirement for cardiovascular surgery related to the procedure within 1 month of the index procedure. Patients were followed for up to 5 years. RESULTS: Thirty-day freedom from major adverse events rate was 98.4% (95% confidence interval: 90.89% to >99.99%). One patient, who did not receive a PLAATO implant, experienced 2 events within 30 days (cardiovascular surgery, death). Treatment success was 100% 1 month after device implantation. At 5-year follow-up, there were 7 deaths, 5 major strokes, 3 minor strokes, 1 cardiac tamponade requiring surgery, 1 probable cerebral hemorrhage/death, and 1 myocardial infarction. Only 1 event (cardiac tamponade) was adjudicated as related to the implant procedure. After up to 5 years of follow-up, the annualized stroke/transient ischemic attack (TIA) rate was 3.8%. The anticipated stroke/TIA rate (with the CHADS(2) scoring method) was 6.6%/year. CONCLUSIONS: The PLAATO system is safe and effective. At 5-year follow-up the annualized stroke/TIA rate in our patients was 3.8%/year, less than predicted by the CHADS(2) scoring system.


Asunto(s)
Anticoagulantes/uso terapéutico , Fibrilación Atrial/terapia , Cateterismo Cardíaco/métodos , Accidente Cerebrovascular/prevención & control , Tromboembolia/prevención & control , Warfarina/uso terapéutico , Adulto , Anciano , Anciano de 80 o más Años , Apéndice Atrial , Fibrilación Atrial/complicaciones , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/mortalidad , Canadá/epidemiología , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/instrumentación , Cateterismo Cardíaco/mortalidad , Procedimientos Quirúrgicos Cardíacos , Cineangiografía , Ecocardiografía Doppler en Color , Ecocardiografía Transesofágica , Diseño de Equipo , Estudios de Factibilidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/etiología , Estudios Prospectivos , Medición de Riesgo , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/mortalidad , Tromboembolia/etiología , Tromboembolia/mortalidad , Factores de Tiempo , Insuficiencia del Tratamiento , Estados Unidos/epidemiología
16.
J Interv Cardiol ; 18(4): 233-41, 2005 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-16115151

RESUMEN

The purpose of this prospective, multicenter trial was to evaluate the safety and effectiveness of the TRAP Vascular Filtration System (VFS) to reduce embolic complications during stenting of diseased saphenous vein grafts (SVGs). Patients with SVG lesions were randomly assigned to undergo stenting with or without the TRAP device. The trial was designed to enroll 752 randomized patients. However, the sponsor terminated the study after a total of 467 patients (358 randomized) were enrolled because of poor recruitment once another distal protection device was approved for clinical use. The primary study endpoint, major adverse cardiac events at 30 days, occurred in 17.3% of control patients and 12.7% of patients treated with the TRAP device (P = 0.24). There was a trend toward a lower incidence of myocardial infarction in the TRAP group compared with the control group (16.2% vs 10.5%, P = 0.12). This difference was predominantly due to a lower incidence of moderate-large infarction (CKMB >5x) in the TRAP group. Use of the TRAP VFS during SVG intervention was safe and was associated with a trend toward a lower incidence of adverse events, however, due to low enrollment the study lacked sufficient power to detect a significant benefit with the device.


Asunto(s)
Cateterismo/instrumentación , Embolia/prevención & control , Oclusión de Injerto Vascular/terapia , Vena Safena/trasplante , Anciano , Femenino , Humanos , Masculino , Estudios Prospectivos , Stents
17.
J Am Coll Cardiol ; 46(1): 9-14, 2005 Jul 05.
Artículo en Inglés | MEDLINE | ID: mdl-15992628

RESUMEN

OBJECTIVES: These studies were conducted to evaluate the feasibility of percutaneous left atrial appendage (LAA) occlusion using the PLAATO system (ev3 Inc., Plymouth, Minnesota). BACKGROUND: Patients with atrial fibrillation (AF) have a five-fold increased risk for stroke. Other studies have shown that more than 90% of atrial thrombi in patients with non-rheumatic AF originate in the LAA. Transvenous closure of the LAA is a new approach in preventing embolism in these patients. METHODS: Within two prospective, multi-center trials, LAA occlusion was attempted in 111 patients (age 71 +/- 9 years). All patients had a contraindication for anticoagulation therapy and at least one additional risk factor for stroke. The primary end point was incidence of major adverse events (MAEs), a composite of stroke, cardiac or neurological death, myocardial infarction, and requirement for procedure-related cardiovascular surgery within the first month. RESULTS: Implantation was successful in 108 of 111 patients (97.3%, 95% confidence interval [CI] 92.3% to 99.4%) who underwent 113 procedures. One patient (0.9%, 95% CI 0.02% to 4.9%) experienced two MAEs within the first 30 days: need for cardiovascular surgery and in-hospital neurological death. Three other patients underwent in-hospital pericardiocentesis due to a hemopericardium. Average follow-up was 9.8 months. Two patients experienced stroke. No migration or mobile thrombus was noted on transesophageal echocardiogram at one and six months after device implantation. CONCLUSIONS: Closing the LAA using the PLAATO system is feasible and can be performed at acceptable risk. It may become an alternative in patients with AF and a contraindication for lifelong anticoagulation treatment.


Asunto(s)
Fibrilación Atrial/complicaciones , Fibrilación Atrial/terapia , Oclusión con Balón/instrumentación , Isquemia Encefálica/prevención & control , Cateterismo Cardíaco/instrumentación , Accidente Cerebrovascular/prevención & control , Anciano , Anciano de 80 o más Años , Anticoagulantes , Apéndice Atrial , Isquemia Encefálica/etiología , Contraindicaciones , Estudios de Factibilidad , Femenino , Estudios de Seguimiento , Humanos , Masculino , Estudios Prospectivos , Accidente Cerebrovascular/etiología , Resultado del Tratamiento
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