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1.
Echocardiography ; 34(4): 625-626, 2017 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-28378353

RESUMEN

Many patients with severe mitral regurgitation cannot undergo conventional mitral valve surgery due to prohibitive surgical risk and are candidates for transcatheter repair with an edge-to-edge technique. Prior reports suggest efficacy with this approach for mitral regurgitation due to hypertrophic cardiomyopathy with left ventricular outflow obstruction. We present a case report of transcatheter mitral valve repair for posterior leaflet prolapse with concomitant left ventricular outflow tract obstruction due to systolic anterior motion of the mitral valve in the absence of hypertrophic cardiomyopathy.


Asunto(s)
Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral/cirugía , Válvula Mitral/cirugía , Obstrucción del Flujo Ventricular Externo/cirugía , Anciano de 80 o más Años , Ecocardiografía , Femenino , Humanos , Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/complicaciones , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Resultado del Tratamiento , Obstrucción del Flujo Ventricular Externo/complicaciones , Obstrucción del Flujo Ventricular Externo/diagnóstico por imagen
2.
Health Expect ; 19(5): 1036-43, 2016 10.
Artículo en Inglés | MEDLINE | ID: mdl-26275070

RESUMEN

BACKGROUND: Patients with severe aortic stenosis (AS) at high risk for aortic valve replacement are a unique population with multiple treatment options, including medical therapy, surgical aortic valve replacement and transcatheter aortic valve replacement (TAVR). Traditionally, in elderly populations, goals of treatment may favour quality of life over survival. Professional guidelines recommend that clinicians engage patients in shared decision making, a process that may lead to decisions more aligned with patient-defined goals of care. Goals of care for high-risk patients with AS are not well defined in the literature, and patient-reported barriers to shared decision making highlight the need for explicit encouragement from clinicians for patient involvement. OBJECTIVE: The purpose of this study was to elicit and report patient-defined goals from elderly patients facing treatment decisions for severe AS. METHODS: This analysis was conducted at Dartmouth-Hitchcock Medical Center, an academic medical institution. In a retrospective manner, we qualitatively analysed goal statements reported by high-risk, elderly patients with severe AS evaluated for TAVR between June 2012 and August 2014. RESULTS: Forty-six patients provided treatment goals during consideration of TAVR and defined preferred outcomes as maintaining independence, staying alive, reducing symptoms or, most commonly, increasing their ability to do a specific activity or hobby. CONCLUSIONS: In the high-risk patient population considering TAVR, patient-reported goals may be obtained with a simple question delivered during the clinical encounter. Encouraging patients to define their goals may lead to a greater degree of shared decision making, as advocated in current professional guidelines.


Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Toma de Decisiones , Objetivos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Relaciones Médico-Paciente , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Investigación Cualitativa , Estudios Retrospectivos , Riesgo , Índice de Severidad de la Enfermedad , Estados Unidos
3.
Front Cardiovasc Med ; 10: 1290024, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-38099223

RESUMEN

Background: Final kissing balloon inflation (FKBI) is a percutaneous coronary intervention (PCI) technique that is considered mandatory to improve outcomes in two-stent strategies, but its use in single-stent bifurcation PCI remains controversial. Methods: In this retrospective cohort study, we identified patients with coronary bifurcation lesions treated with one stent from January 2012 to March 2021 at a single academic medical center. Incidence rates per 1,000 patient-years (IR1000) were calculated for the outcomes of all-cause mortality, myocardial infarction (MI), stent thrombosis (ST), target lesion revascularization (TLR), coronary artery bypass graft (CABG), and cardiac readmission between patients who received FKBI and those who did not over a median follow up of 2.3 years. Studied outcomes were adjusted for all baseline clinical and procedural characteristics. Results: This study included 893 consecutive patients of which 256 received FKBI and 637 did not. The IR1000 for MI were 51.1 and 27.6 for patients who received FKBI and patients who did not, respectively (adjusted HR = 2.44, p = 0.001). The IR1000 for death were 31.2 and 52.3 for patients who received FKBI and patients who did not, respectively (adjusted HR = 0.68, p = 0.141). The incidence rates of ST, TLR, CABG, and cardiac readmissions were similar between patients who received FKBI and those who did not. Conclusions: These results suggest that performing FKBI in a one-stent technique was associated with higher rates of myocardial infarction, particularly in the first 6 months, and no difference in death, ST, TLR, CABG, and cardiac readmission rates.

4.
Semin Thromb Hemost ; 38(8): 893-904, 2012 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-23041981

RESUMEN

The genes encoding the cytochrome P450 2C9 enzyme (CYP2C9) and vitamin K-epoxide reductase complex unit 1 (VKORC1) are major determinants of anticoagulant response to warfarin. Together with patient demographics and clinical information, they account for approximately one-half of the warfarin dose variance in individuals of European descent. Recent prospective and randomized controlled trial data support pharmacogenetic guidance with their use in warfarin dose initiation and titration. Benefits from pharmacogenetics-guided warfarin dosing have been reported to extend beyond the period of initial dosing, with supportive data indicating benefits to at least 3 months. The genetic effects of VKORC1 and CYP2C9 in African and Asian populations are concordant with those in individuals of European ancestry; however, frequency distribution of allelic variants can vary considerably between major populations. Future randomized controlled trials in multiethnic settings using population-specific dosing algorithms will allow us to further ascertain the generalizability and cost-effectiveness of pharmacogenetics-guided warfarin therapy. Additional genome-wide association studies may help us to improve and refine dosing algorithms and potentially identify novel biological pathways.


Asunto(s)
Anticoagulantes/efectos adversos , Hidrocarburo de Aril Hidroxilasas/genética , Oxigenasas de Función Mixta/genética , Warfarina/efectos adversos , Anticoagulantes/farmacología , Hidrocarburo de Aril Hidroxilasas/metabolismo , Citocromo P-450 CYP2C9 , Variación Genética , Genotipo , Humanos , Relación Normalizada Internacional , Oxigenasas de Función Mixta/metabolismo , Vitamina K Epóxido Reductasas , Warfarina/farmacología
5.
Catheter Cardiovasc Interv ; 75(3): 378-86, 2010 Feb 15.
Artículo en Inglés | MEDLINE | ID: mdl-19937779

RESUMEN

BACKGROUND: The long-term prognostic implication of post-procedural hematocrit drops in patients undergoing cardiac catheterization outside the clinical trial setting is not well defined. METHODS: Data was prospectively collected from 12,661 patients undergoing diagnostic or interventional cardiac catheterization between July 1998 and July 2006. Patients were divided into three cohorts based upon the degree of hematocrit change: drop greater than 6, drop between 3 and 6, and drop less than 3. In-hospital major adverse events, 30-day mortality, and long-term all-cause mortality were recorded. RESULTS: Patients with larger reductions in hematocrit were more likely to be older, female, and have a higher baseline hematocrit, present with acute myocardial infarction, develop cardiogenic shock, require emergent catheterization, develop retroperitoneal bleeds and large hematomas, receive transfusions, have longer index hospitalizations, develop subacute stent thrombosis, and have higher 30-day and long-term mortality. An increase in long-term mortality was observed with progressive hematocrit drop. This finding is largely driven by early (30 day) mortality, as trends were no longer significant after rezeroing mortality. Hematocrit drop was not an independent risk factor for 30-day mortality. Transfusion and low baseline hematocrit were identified as independent predictors of near and long-term mortality. CONCLUSIONS: Periprocedural bleeding, defined by hematocrit drop, is associated with increased near-term and long-term mortality in patients undergoing diagnostic and therapeutic cardiac catheterization procedures. Long-term mortality is largely driven by up front 30-day mortality. Hematocrit drop was not an independent predictor for near-term mortality. Transfusion and low baseline hematocrit were independent predictors for near and long-term mortality.


Asunto(s)
Cateterismo Cardíaco/mortalidad , Angiografía Coronaria/mortalidad , Hematócrito , Hemorragia Posoperatoria/mortalidad , Anciano , Anciano de 80 o más Años , Cateterismo Cardíaco/efectos adversos , Angiografía Coronaria/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Hemorragia Posoperatoria/etiología , Pronóstico , Sistema de Registros , Factores de Riesgo , Análisis de Supervivencia , Factores de Tiempo
6.
Catheter Cardiovasc Interv ; 76(4): 473-81, 2010 Oct 01.
Artículo en Inglés | MEDLINE | ID: mdl-20882647

RESUMEN

OBJECTIVES: We sought to determine if differences existed in in-hospital outcomes, long-term rates of target vessel revascularization (TVR), and/or long-term mortality trends between patients with diabetes mellitus undergoing percutaneous coronary intervention (PCI) with either a drug-eluting stent(s) (DES) or a bare metal stent(s) (BMS). BACKGROUND: Short- and long-term clinical outcomes of patients with diabetes mellitus undergoing PCI with DES versus BMS remain inconsistent between randomized-controlled trials (RCTs) and observational studies. METHODS: Data were collected prospectively on diabetics undergoing PCI with either DES or BMS from January 2000 to June 2008. Demographic information, medical histories, in-hospital outcomes, and long-term TVR and mortality trends were obtained for all patients. RESULTS: A total of 1,319 patients were included in the study. Diabetics receiving DES had a significant reduction in index admission MACE compared to diabetics receiving BMS. Using multivariable adjustment, after a mean follow-up of 2.5 years (maximum 5 years), diabetics who received DES had a 38% decreased risk of TVR compared to diabetics with BMS [HR 0.62 (95% CI: 0.43-0.90)]; diabetics with DES had an insignificant adjusted improvement in long-term survival compared to diabetics with BMS [HR 0.72 (95% CI: 0.52-1.00)]. These long-term survival and TVR rates were confirmed using propensity scoring. CONCLUSIONS: The use of DES when compared with BMS among diabetics undergoing PCI is associated with significant improvement in long-term TVR, with an insignificant similar trend in all-cause mortality. The long-term results of this observational study are consistent with prior RCTs after adjusting for confounding variables.


Asunto(s)
Angioplastia Coronaria con Balón/instrumentación , Diabetes Mellitus Tipo 1/complicaciones , Diabetes Mellitus Tipo 2/complicaciones , Stents Liberadores de Fármacos , Cardiopatías/terapia , Metales , Stents , Anciano , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/mortalidad , Diabetes Mellitus Tipo 1/mortalidad , Diabetes Mellitus Tipo 2/mortalidad , Femenino , Cardiopatías/complicaciones , Cardiopatías/mortalidad , Humanos , Estimación de Kaplan-Meier , Modelos Logísticos , Masculino , Persona de Mediana Edad , New England , Puntaje de Propensión , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Diseño de Prótesis , Sistema de Registros , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
7.
J Interv Cardiol ; 23(2): 167-75, 2010 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-20236213

RESUMEN

We compare real-world, extended target vessel revascularization (TVR)-free survival following percutaneous coronary intervention (PCI) for patients receiving either sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES) following an index drug-eluting stent (DES) supported procedure. We analyzed 2,363 consecutive patients having first DES-supported PCI at receiving PES (n = 1,012) or SES (n = 1,332) from April 2004 to July 2006. Baseline clinical and procedural characteristics and in-hospital outcomes were recorded during the time of the index procedure and extended clinical outcomes data were obtained thereafter. TVR and all cause mortality were identified during the study period. Adjusted Kaplan-Meier and Cox's proportional hazard survival methods were performed. TVR-free survival at 2.3 years was 91.3% for SES compared with 88.9% for PES (P = 0.06). Kaplan-Meier survival curves did not significantly differ (adjusted hazard ratio -1.39 [95% CI 0.99-1.97]) between the SES and PES patient cohorts. TVR was similar between the stent platforms at one (96.6% for SES [95% CI 95.3-97.6] vs. 95.7% for PES [95% CI 94.1-96.9]) and two (95.0%[95% CI 93.0-96.4] for SES vs. 93.7% for PES [95% CI 91.6-95.3]) years. Overall survival at 2 years was 96.2% for SES (95% CI 94.7-97.3) and 95.3% for PES (95% CI 93.7-96.5). SES and PES drug-eluting stent platforms have good and similar extended outcomes in this real world registry of unselected patients having PCI.


Asunto(s)
Angioplastia Coronaria con Balón , Enfermedad Coronaria/terapia , Stents Liberadores de Fármacos , Paclitaxel/administración & dosificación , Sirolimus/administración & dosificación , Anciano , Estudios de Cohortes , Angiografía Coronaria , Enfermedad Coronaria/diagnóstico por imagen , Femenino , Estudios de Seguimiento , Humanos , Pacientes Internos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Sistema de Registros , Resultado del Tratamiento
8.
J Interv Cardiol ; 22(5): 431-6, 2009 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-19627431

RESUMEN

OBJECTIVE: The purpose of this investigation was to characterize clinical variables and angiographic distribution of coronary atherosclerosis to classify patients with de novo left main (LM) disease in a real-world population presenting for coronary angiography. BACKGROUND: Limited quantitative and angiographic published data exist that provide detailed quantitative information to classify potential target population for elective LM percutaneous coronary intervention (PCI) and guide development of dedicated LM PCI platforms. METHODS: Medical history and clinical presentation were prospectively collected on 177 consecutive patients with LM stenosis > or =50% by coronary angiography. Blinded quantitative coronary angiography (QCA) was performed on all LM stenoses to classify LM-A (ostial), LM-B (nonostial, non-bifurcation), and LM-C (bifurcation involvement). QCA was performed on the left anterior descending (LAD), left circumflex (LCx), and right coronary arteries (RCA) and branches (> or =2.5 mm) to identify lesions with > or =60% stenosis or occlusion. RESULTS: No differences in baseline clinical history or presentation discriminated the distribution patterns of LM stenosis. QCA revealed 66% of LM stenoses were LM-C. Mean LM reference vessel diameter was 4.65 mm and average lesion length was 11.12 mm. Around 88.7% of patients had at least one lesion > or =60% in a major epicardial artery and 32.2% of patients had RCA chronic total occlusion. Right-to-left coronary collateralization was only identified in patients with obstructive stenosis in the LAD or LCx in addition to the LM stenosis. CONCLUSION: Dedicated LM stent platforms may need to be developed to accommodate larger vessel size and bifurcation distributions. A majority of patients with LM stenosis will require adjunctive epicardial vessel PCI to achieve complete anatomic revascularization.


Asunto(s)
Enfermedad de la Arteria Coronaria/clasificación , Enfermedad de la Arteria Coronaria/diagnóstico , Anciano , Angiografía Coronaria , Vasos Coronarios/patología , Femenino , Humanos , Masculino
10.
Am Heart J ; 155(2): 260-6, 2008 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-18215595

RESUMEN

BACKGROUND: A prediction rule for determining the post-percutaneous coronary intervention (PCI) risk of developing contrast-induced nephropathy (> or = 25% or > or = 0.5 mg/dL increase in creatinine) has been reported. However, little work has been done on predicting pre-PCI patient-specific risk for developing more serious renal dysfunction (SRD; new dialysis, > or = 2.0 mg/dL absolute increase in creatinine, or a > or = 50% increase in creatinine). We hypothesized that preprocedural patient characteristics could be used to predict the risk of post-PCI SRD. METHODS: Data were prospectively collected on a consecutive series of 11141 patients undergoing PCI without dialysis in northern New England from 2003 to 2005. Multivariate logistic regression model was used to identify the combination of patient characteristics most predictive of developing post-PCI SRD. The ability of the model to discriminate was quantified using a bootstrap validated C-Index (area under the receiver operating characteristic [ROC] curve). Its calibration was tested with a Hosmer-Lemeshow statistic. The model was validated on PCI procedures in 2006. RESULTS: Serious renal dysfunction occurred in 0.74% of patients (83/11141) with an associated inhospital mortality of 19.3% versus 0.9% in those without SRD. The model discriminated well between patients who did and did not develop SRD after PCI (ROC 0.87, 95% CI 0.82-0.91). Preprocedural creatinine (37%), congestive heart failure (24%), and diabetes (15%) accounted for 76% of the predictive ability of the model. The other factors contributed 24%: urgent and emergent priority (10%), preprocedural intra-aortic balloon pump use (8%), age > or = 80 years (5%), and female sex (1%). Validation of the model was successful with ROC: 0.84 (95% CI 0.80-0.89). CONCLUSIONS: Although infrequent, the occurrence of SRD after PCI is associated with a very high inhospital mortality. We developed and validated a robust clinical prediction rule to determine which patients are at high risk for SRD. Use of this model may help physicians perform targeted interventions to reduce this risk.


Asunto(s)
Angioplastia Coronaria con Balón/efectos adversos , Medios de Contraste/efectos adversos , Enfermedades Renales/epidemiología , Anciano , Anciano de 80 o más Años , Área Bajo la Curva , Femenino , Humanos , Enfermedades Renales/etiología , Enfermedades Renales/mortalidad , Modelos Logísticos , Masculino , Persona de Mediana Edad , Modelos Estadísticos , Valor Predictivo de las Pruebas , Estudios Prospectivos , Curva ROC , Sistema de Registros , Medición de Riesgo , Factores de Riesgo
11.
Catheter Cardiovasc Interv ; 72(3): 347-354, 2008 Sep 01.
Artículo en Inglés | MEDLINE | ID: mdl-18729173

RESUMEN

OBJECTIVES: We sought to determine if transient and persistent elevations in creatinine following percutaneous coronary intervention (PCI) resulted in poor survival. BACKGROUND: Limited survival data exist that defines the natural survival history of transient and persistent renal dysfunction following interventional PCI cases. METHODS: Data were collected prospectively on 7,856 consecutive patients undergoing PCI from January 1, 2000 to July 31, 2006. Ninety-three patients were excluded due to pre-PCI dialysis. Patients were stratified into three categories of renal dysfunction: no renal dysfunction from baseline (<0.5 mg/dL increase in creatinine within 48 hr of the procedure), transient renal dysfunction (> or =0.5 mg/dL increase in creatinine within 48 hr with return to normal within 2 weeks), and persistent renal dysfunction (> or =0.5 mg/dL increase in creatinine without returning to normal within 2 weeks of the procedure). Mortality was determined by comparing with the Social Security Death Master File. RESULTS: Median survival was 3.2 years (mean 3.4). Renal dysfunction occurred in 250 patients (0.5 mg/dL increase in creatinine). Survival was significantly different between patients at 1, 3.2, and 7.5 years (P-value < 0.001): no renal dysfunction (95%, 88%, 75%), with transient (61%, 42%, 0%), and with persistent (58%, 44%, 36%) renal dysfunction. Patients with transient or persistent renal dysfunction had a twofold-threefold increased risk of 7.5-year mortality compared with patients with no renal dysfunction. CONCLUSIONS: Both transient and persistent postprocedural renal dysfunction are prognostically significant for mortality during extended follow-up. Renal dysfunction should be closely monitored before and after PCI.


Asunto(s)
Angioplastia Coronaria con Balón , Medios de Contraste/efectos adversos , Enfermedad de la Arteria Coronaria/terapia , Creatinina/sangre , Enfermedades Renales/etiología , Riñón/fisiopatología , Anciano , Anciano de 80 o más Años , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/mortalidad , Enfermedad de la Arteria Coronaria/mortalidad , Enfermedad de la Arteria Coronaria/fisiopatología , Femenino , Humanos , Estimación de Kaplan-Meier , Enfermedades Renales/mortalidad , Enfermedades Renales/fisiopatología , Pruebas de Función Renal , Masculino , Persona de Mediana Edad , New Hampshire/epidemiología , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Sistema de Registros , Medición de Riesgo , Factores de Riesgo , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del Tratamiento , Regulación hacia Arriba
12.
Anesth Analg ; 104(1): 15-26, 2007 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-17179239

RESUMEN

The American College of Cardiology/American Heart Association (ACC/AHA) Task Force on Practice Guidelines makes every effort to avoid any actual, potential, or perceived conflict of interest that might arise as a result of an industry relationship or personal interest of the writing committee. Specifically, all members of the writing committee, as well as peer reviewers of the document, were asked to provide disclosure statements of all such relationships that might be perceived as real or potential conflicts of interest. These statements are reviewed by the parent task force, reported orally to all members of the writing committee at each meeting, and updated and reviewed by the writing committee as changes occur. Please see Appendix 1 for author relationships with industry and Appendix 2 for peer reviewer relationships with industry. These guidelines attempt to define practices that meet the needs of most patients in most circumstances. These guideline recommendations reflect a consensus of expert opinion after a thorough review of the available, current scientific evidence and are intended to improve patient care. If these guidelines are used as the basis for regulatory/payer decisions, the ultimate goal is quality of care and serving the patient's best interests. The ultimate judgment regarding care of a particular patient must be made by the healthcare provider and patient in light of all the circumstances presented by that patient.


Asunto(s)
Antagonistas Adrenérgicos beta/uso terapéutico , American Heart Association , Cardiopatías/prevención & control , Complicaciones Intraoperatorias/prevención & control , Atención Perioperativa , Cardiología , Humanos , Estados Unidos
13.
Matrix Biol ; 63: 69-90, 2017 11.
Artículo en Inglés | MEDLINE | ID: mdl-28126521

RESUMEN

The HS3ST1 gene controls endothelial cell production of HSAT+ - a form of heparan sulfate containing a specific pentasaccharide motif that binds the anticoagulant protein antithrombin (AT). HSAT+ has long been thought to act as an endogenous anticoagulant; however, coagulation was normal in Hs3st1-/- mice that have greatly reduced HSAT+ (HajMohammadi et al., 2003). This finding indicates that HSAT+ is not essential for AT's anticoagulant activity. To determine if HSAT+ is involved in AT's poorly understood inflammomodulatory activities, Hs3st1-/- and Hs3st1+/+ mice were subjected to a model of acute septic shock. Compared with Hs3st1+/+ mice, Hs3st1-/- mice were more susceptible to LPS-induced death due to an increased sensitivity to TNF. For Hs3st1+/+ mice, AT treatment reduced LPS-lethality, reduced leukocyte firm adhesion to endothelial cells, and dilated isolated coronary arterioles. Conversely, for Hs3st1-/- mice, AT induced the opposite effects. Thus, in the context of acute inflammation, HSAT+ selectively mediates AT's anti-inflammatory activity; in the absence of HSAT+, AT's pro-inflammatory effects predominate. To explore if the anti-inflammatory action of HSAT+ also protects against a chronic vascular-inflammatory disease, atherosclerosis, we conducted a human candidate-gene association study on >2000 coronary catheterization patients. Bioinformatic analysis of the HS3ST1 gene identified an intronic SNP, rs16881446, in a putative transcriptional regulatory region. The rs16881446G/G genotype independently associated with the severity of coronary artery disease and atherosclerotic cardiovascular events. In primary endothelial cells, the rs16881446G allele associated with reduced HS3ST1 expression. Together with the mouse data, this leads us to conclude that the HS3ST1 gene is required for AT's anti-inflammatory activity that appears to protect against acute and chronic inflammatory disorders.


Asunto(s)
Antitrombinas/fisiología , Aterosclerosis/genética , Enfermedades de las Arterias Carótidas/genética , Sulfotransferasas/genética , Animales , Antitrombinas/farmacología , Aterosclerosis/enzimología , Aterosclerosis/inmunología , Enfermedades de las Arterias Carótidas/enzimología , Enfermedades de las Arterias Carótidas/inmunología , Femenino , Estudios de Asociación Genética , Genotipo , Humanos , Inmunomodulación , Desequilibrio de Ligamiento , Lipopolisacáridos/farmacología , Masculino , Ratones de la Cepa 129 , Ratones Endogámicos C57BL , Ratones Noqueados , Polimorfismo de Nucleótido Simple , Factor de Necrosis Tumoral alfa/fisiología , Vasodilatación
14.
Circulation ; 112(18): 2883-6, 2005 Nov 01.
Artículo en Inglés | MEDLINE | ID: mdl-16267261

RESUMEN

The Second Dartmouth Device Development Symposium held in October 2004 brought together leaders from the medical device community, including clinical investigators, senior representatives from the US Food and Drug Administration, large and small device manufacturers, and representatives from the financial community to examine difficult issues confronting device development. The role of the Humanitarian Use Device/Humanitarian Device Exemption (HUD/HDE) pathway in the development of new cardiovascular devices was discussed in this forum. The HUD/HDE pathway was created by Congress to facilitate the availability of medical devices for "orphan" indications, ie, those affecting <4000 individuals within the United States each year. The HUD/HDE pathway streamlines the approval process and permits less well-characterized devices to enter the market. HDE approval focuses primarily on issues of safety and scientific soundness and does not require demonstration of efficacy. In the 7 years since the first device was approved in 1997, a total of 35 HDEs have been granted (23 devices, 6 diagnostic tests). As the costs to gain regulatory approval for commonly used devices increase, companies often seek alternative ways to gain market access, including the HUD/HDE pathway. For a given device, there may be multiple legitimate and distinct indications, including indications that meet the HUD criteria. Companies must choose how and when to pursue each of these indications. The consensus of symposium participants was for the HUD/HDE pathway to be reserved for true orphan indications and not be viewed strategically as part of the clinical development plan to access a large market.


Asunto(s)
Altruismo , Cardiología/normas , Enfermedades Cardiovasculares/cirugía , Aprobación de Recursos/normas , Cateterismo Cardíaco/normas , Cardiopatías/cirugía , Humanos , Estados Unidos , United States Food and Drug Administration
15.
Circulation ; 112(9 Suppl): I371-6, 2005 Aug 30.
Artículo en Inglés | MEDLINE | ID: mdl-16159849

RESUMEN

BACKGROUND: Randomized trials comparing coronary artery bypass graft surgery (CABG) with percutaneous coronary interventions (PCIs) for patients with multivessel coronary disease (MVD) report similar long-term survival for CABG and PCI. These studies used a highly selected population of patients and providers, and their results may not be generalizable to actual care. Our goal in this study was to compare long-term survival of MVD patients treated with CABG vs PCI in contemporary practice. METHODS AND RESULTS: From our northern New England registries of consecutive coronary revascularizations, we identified 10,198 CABG and 4,295 PCI patients with MVD who may have been eligible for either procedure between 1994 and 2001. Vital status was obtained by linkage to the National Death Index. Proportional-hazards regression was used to calculate hazard ratios (HRs) for survival in CABG vs PCI patients after adjustment for comorbidities and disease characteristics. CABG patients were older; had more comorbidities, more 3-vessel disease, and lower ejection fractions; and were more completely revascularized. Adjusted long-term survival for patients with 3-vessel disease was better after CABG than PCI (HR, 0.60; P<0.01) but not for patients with 2-vessel disease (HR, 0.98; P=0.77). The survival advantage of CABG for 3-vessel disease patients was present in all patient populations, including women, diabetics, and the elderly and in the era of high stent utilization. CONCLUSIONS: In contemporary practice, survival for patients with 3-vessel coronary disease is better after CABG than PCI, an observation that patients and physicians should carefully consider when deciding on a revascularization strategy.


Asunto(s)
Angioplastia Coronaria con Balón/estadística & datos numéricos , Puente de Arteria Coronaria/estadística & datos numéricos , Enfermedad Coronaria/terapia , Anciano , Estudios de Cohortes , Comorbilidad , Enfermedad Coronaria/mortalidad , Enfermedad Coronaria/cirugía , Diabetes Mellitus/epidemiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , New England/epidemiología , Modelos de Riesgos Proporcionales , Sistema de Registros/estadística & datos numéricos , Estudios Retrospectivos , Volumen Sistólico , Análisis de Supervivencia
18.
J Am Coll Cardiol ; 40(12): 2092-101, 2002 Dec 18.
Artículo en Inglés | MEDLINE | ID: mdl-12505219

RESUMEN

OBJECTIVES: We sought to determine whether the changing practice of interventional cardiology has been associated with improved outcomes for women, and how these outcomes compare with those for men. BACKGROUND: Previous work from the early 1990s suggested women are at a higher risk than men for adverse outcomes after percutaneous coronary interventions (PCIs). From 1994 to 1999 data were collected on 33,666 consecutive hospital admissions for a PCI in Northern New England. Multivariate models were used to adjust for differences in case-mix across year of procedure when comparing outcomes. Direct standardization was used to calculate adjusted rates. RESULTS: From 1994 to 1999, the case-mix worsened for both women and men, although women had more co-morbidities than did men throughout the period. Stent use increased over time (>75% in 1999). Concomitantly, the need for emergency coronary artery bypass graft surgery (CABG) decreased significantly (p(trend) < or = 0.001; in 1999: 0.06% for women, 0.05% for men). Although the emergency CABG rates were higher for women at the beginning of the study, by the end, they were comparable (adjusted odds ratio 1.34, 95% confidence interval 0.76 to 2.38, p = 0.315). The myocardial infarction (MI) rates decreased over time for both women (by 29.7%, p(trend) = 0.378) and men (by 37.6%, p(trend) = 0.009) and did not differ by gender. The mortality rates did not decrease significantly over time and were not significantly different between the genders (mean 1.21% for women, 1.06% for men; p = 0.096). CONCLUSIONS: Concurrent with the changing practice of PCI, and despite treating sicker patients, there have been important improvements in post-PCI CABG and MI rates for women, as well as for men. Unlike in earlier years, there are no longer significant differences in outcomes by gender.


Asunto(s)
Angioplastia Coronaria con Balón/tendencias , Evaluación de Resultado en la Atención de Salud , Anciano , Anciano de 80 o más Años , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/estadística & datos numéricos , Puente de Arteria Coronaria/tendencias , Enfermedad Coronaria/terapia , Femenino , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Mortalidad , New England , Evaluación de Resultado en la Atención de Salud/tendencias , Sistema de Registros , Factores de Riesgo , Factores Sexuales , Stents , Resultado del Tratamiento
19.
Am J Cardiol ; 96(5): 668-72, 2005 Sep 01.
Artículo en Inglés | MEDLINE | ID: mdl-16125492

RESUMEN

Limited published data exist about how the introduction of drug-eluting stents (DESs) has affected the technical aspects of percutaneous coronary intervention and in-hospital patient outcomes in clinical practice. A total of 2,215 consecutive patients who underwent percutaneous coronary intervention for de novo coronary artery disease were divided into 2 cohorts: the pre-DES era (May 1, 2002 to April 30, 2003) and the DES era (May 1, 2003 to April 30, 2004). The procedural success rates (94.9% vs 96.4%, respectively; p = 0.075) and the in-hospital major adverse events (6.4% vs 5.7%, respectively; p = 0.53) were similar between the pre-DES and DES eras. The DES percentage of use increased from 49.5% in the first quarter to 84.1% in the final quarter of the first year after the introduction of this technology (p <0.0001). The results of our study have shown that despite more complex percutaneous coronary intervention procedures with tendencies for more complete lesion coverage and anatomic revascularization, the procedural success and in-hospital outcomes have been comparable since the introduction of DESs.


Asunto(s)
Angioplastia Coronaria con Balón/instrumentación , Materiales Biocompatibles Revestidos , Enfermedad Coronaria/terapia , Metales , Stents , Angiografía Coronaria , Enfermedad Coronaria/diagnóstico por imagen , Reestenosis Coronaria/epidemiología , Reestenosis Coronaria/prevención & control , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del Tratamiento , Estados Unidos/epidemiología
20.
Am Heart J ; 145(6): 1022-9, 2003 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-12796758

RESUMEN

OBJECTIVES: Using a large, current, regional registry of percutaneous coronary interventions (PCI), we identified risk factors for postprocedure vascular complications and developed a scoring system to estimate individual patient risk. BACKGROUND: A vascular complication (access-site injury requiring treatment or bleeding requiring transfusion) is a potentially avoidable outcome of PCI. METHODS: Data were collected on 18,137 consecutive patients undergoing PCI in northern New England from January 1997 to December 1999. Multivariate regression was used to identify characteristics associated with vascular complications and to develop a scoring system to predict risk. RESULTS: The rate of vascular complication was 2.98% (541 cases). Variables associated with increased risk in the multivariate analysis included age >or=70, odds ratio (OR) 2.7, female sex (OR 2.4), body surface area <1.6 m(2) (OR 1.9), history of congestive heart failure (OR 1.4), chronic obstructive pulmonary disease (OR 1.5), renal failure (OR 1.9), lower extremity vascular disease (OR 1.4), bleeding disorder (OR 1.68), emergent priority (OR 2.3), myocardial infarction (OR 1.7), shock (1.86), >or=1 type B2 (OR 1.32) or type C (OR 1.7) lesions, 3-vessel PCI (OR 1.5), use of thienopyridines (OR 1.4) or use of glycoprotein IIb/IIIa receptor inhibitors (OR 1.9). The model performed well in tests for significance, discrimination, and calibration. The scoring system captured 75% of actual vascular complications in its highest quintiles of predicted risk. CONCLUSION: Predicting the risk of post-PCI vascular complications is feasible. This information may be useful for clinical decision-making and institutional efforts at quality improvement.


Asunto(s)
Angioplastia Coronaria con Balón/efectos adversos , Puente de Arteria Coronaria/efectos adversos , Enfermedades Vasculares/etiología , Anciano , Anciano de 80 o más Años , Análisis de Varianza , Índice de Masa Corporal , Enfermedad Coronaria/terapia , Estudios de Factibilidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Oportunidad Relativa , Curva ROC , Sistema de Registros , Estudios Retrospectivos , Factores de Riesgo , Factores Sexuales , Stents
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