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1.
N Engl J Med ; 378(22): 2069-2077, 2018 May 31.
Artículo en Inglés | MEDLINE | ID: mdl-29708851

RESUMEN

BACKGROUND: The use of radial-artery grafts for coronary-artery bypass grafting (CABG) may result in better postoperative outcomes than the use of saphenous-vein grafts. However, randomized, controlled trials comparing radial-artery grafts and saphenous-vein grafts have been individually underpowered to detect differences in clinical outcomes. We performed a patient-level combined analysis of randomized, controlled trials to compare radial-artery grafts and saphenous-vein grafts for CABG. METHODS: Six trials were identified. The primary outcome was a composite of death, myocardial infarction, or repeat revascularization. The secondary outcome was graft patency on follow-up angiography. Mixed-effects Cox regression models were used to estimate the treatment effect on the outcomes. RESULTS: A total of 1036 patients were included in the analysis (534 patients with radial-artery grafts and 502 patients with saphenous-vein grafts). After a mean (±SD) follow-up time of 60±30 months, the incidence of adverse cardiac events was significantly lower in association with radial-artery grafts than with saphenous-vein grafts (hazard ratio, 0.67; 95% confidence interval [CI], 0.49 to 0.90; P=0.01). At follow-up angiography (mean follow-up, 50±30 months), the use of radial-artery grafts was also associated with a significantly lower risk of occlusion (hazard ratio, 0.44; 95% CI, 0.28 to 0.70; P<0.001). As compared with the use of saphenous-vein grafts, the use of radial-artery grafts was associated with a nominally lower incidence of myocardial infarction (hazard ratio, 0.72; 95% CI, 0.53 to 0.99; P=0.04) and a lower incidence of repeat revascularization (hazard ratio, 0.50; 95% CI, 0.40 to 0.63; P<0.001) but not a lower incidence of death from any cause (hazard ratio, 0.90; 95% CI, 0.59 to 1.41; P=0.68). CONCLUSIONS: As compared with the use of saphenous-vein grafts, the use of radial-artery grafts for CABG resulted in a lower rate of adverse cardiac events and a higher rate of patency at 5 years of follow-up. (Funded by Weill Cornell Medicine and others.).


Asunto(s)
Puente de Arteria Coronaria/métodos , Enfermedad de la Arteria Coronaria/cirugía , Arteria Radial/trasplante , Vena Safena/trasplante , Grado de Desobstrucción Vascular , Anciano , Angiografía Coronaria , Puente de Arteria Coronaria/efectos adversos , Enfermedad de la Arteria Coronaria/mortalidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/epidemiología , Complicaciones Posoperatorias/epidemiología , Modelos de Riesgos Proporcionales , Ensayos Clínicos Controlados Aleatorios como Asunto , Reoperación/estadística & datos numéricos , Insuficiencia del Tratamiento
2.
Eur Heart J Suppl ; 22(Suppl Pt t): P56-P59, 2020 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-33390873

RESUMEN

The global COVID-19 pandemic has led to unprecedented change throughout society.1 As the articles in this supplement outline, all segments of the broader cardiovascular community have been forced to adapt, to change models of care delivery, and to evolve and innovate in order to deliver optimal management for cardiovascular patients. The medtech/device industry has not been exempt from such change and has been forced to navigate direct and indirect COVID-associated disruption, with effects felt from supply chain logistics to the entire product lifecycle, from the running of clinical trials to new device approvals and managing training, proctoring and congresses in an increasingly-online world. This sea-change in circumstances itself has enforced the industry, in effect, to disrupt its own processes, models and activities. Whilst some of these changes may be temporary, many will endure for some time and some will doubtless become permanent; one thing is for sure: the healthcare ecosystem, including the medical device industry, will never look quite the same again. Although the pandemic has brought a short- to medium-term medical crisis to many countries, its role as a powerful disruptor cannot be underestimated, and may indeed prove to be a force for long-term good, given the accelerated innovation and rapid adaptation that it has cultivated.

3.
JAMA ; 324(2): 179-187, 2020 07 14.
Artículo en Inglés | MEDLINE | ID: mdl-32662861

RESUMEN

Importance: Observational studies have suggested that the use of radial artery grafts for coronary artery bypass grafting may improve clinical outcomes compared with the use of saphenous vein grafts, but this has not been confirmed in randomized trials. Objective: To compare clinical outcomes between patients receiving radial artery vs saphenous vein grafts for coronary artery bypass grafting after long-term follow-up. Design, Setting, and Participants: Patient-level pooled analysis comparing radial artery vs saphenous vein graft in adult patients undergoing isolated coronary artery bypass grafting from 5 countries (Australia, Italy, Serbia, South Korea, and the United Kingdom), with enrollment from 1997 to 2009 and follow-up completed in 2019. Interventions: Patients were randomized to undergo either radial artery (n = 534) or saphenous vein (n = 502) grafts for coronary artery bypass grafting. Main Outcomes and Measures: The primary outcome was a composite of death, myocardial infarction, or repeat revascularization and the secondary outcome was a composite of death or myocardial infarction. Results: A total of 1036 patients were randomized (mean age, 66.6 years in the radial artery group vs 67.1 years in the saphenous vein group; 376 [70.4%] men in the radial artery group vs 351 [69.9%] in the saphenous vein group); 942 (90.9%) of the originally randomized patients completed 10 years of follow-up (510 in the radial artery group). At a median (interquartile range) follow-up of 10 (10-11) years, the use of the radial artery, compared with the saphenous vein, in coronary artery bypass grafting was associated with a statistically significant reduction in the incidence of the composite outcome of death, myocardial infarction, or repeat revascularization (220 vs 237 total events; 41 vs 47 events per 1000 patient-years; hazard ratio, 0.73 [95% CI, 0.61-0.88]; P < .001) and of the composite of death or myocardial infarction (188 vs 193 total events; 35 vs 38 events per 1000 patient-years; hazard ratio, 0.77 [95% CI, 0.63-0.94]; P = .01). Conclusions and Relevance: In this individual participant data meta-analysis with a median follow-up of 10 years, among patients undergoing coronary artery bypass grafting, the use of the radial artery compared with the saphenous vein was associated with a lower risk of a composite of cardiovascular outcomes.


Asunto(s)
Puente de Arteria Coronaria/métodos , Arteria Radial/trasplante , Vena Safena/trasplante , Anciano , Puente de Arteria Coronaria/mortalidad , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Masculino , Infarto del Miocardio/epidemiología , Complicaciones Posoperatorias/epidemiología , Ensayos Clínicos Controlados Aleatorios como Asunto , Reoperación/estadística & datos numéricos , Factores de Tiempo , Resultado del Tratamiento
4.
Circulation ; 137(4): 388-399, 2018 01 23.
Artículo en Inglés | MEDLINE | ID: mdl-29358344

RESUMEN

Bioprostheses are prone to structural valve degeneration, resulting in limited long-term durability. A significant challenge when comparing the durability of different types of bioprostheses is the lack of a standardized terminology for the definition of a degenerated valve. This issue becomes especially important when we try to compare the degeneration rate of surgically inserted and transcatheter bioprosthetic valves. This document, by the VIVID (Valve-in-Valve International Data), proposes practical and standardized definitions of valve degeneration and provides recommendations for the timing of clinical and imaging follow-up assessments accordingly. Its goal is to improve the quality of research and clinical care for patients with deteriorated bioprostheses by providing objective and strict criteria that can be utilized in future clinical trials. We hope that the adoption of these criteria by both the cardiological and surgical communities will lead to improved comparability and interpretation of durability analyses.


Asunto(s)
Bioprótesis/clasificación , Enfermedades de las Válvulas Cardíacas/cirugía , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Prótesis Valvulares Cardíacas/clasificación , Válvulas Cardíacas/cirugía , Falla de Prótesis , Terminología como Asunto , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Remoción de Dispositivos , Enfermedades de las Válvulas Cardíacas/diagnóstico por imagen , Enfermedades de las Válvulas Cardíacas/fisiopatología , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Válvulas Cardíacas/diagnóstico por imagen , Válvulas Cardíacas/fisiopatología , Humanos , Valor Predictivo de las Pruebas , Diseño de Prótesis , Factores de Tiempo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del Tratamiento
5.
Lancet ; 387(10025): 1312-23, 2016 Mar 26.
Artículo en Inglés | MEDLINE | ID: mdl-27025437

RESUMEN

The management of aortic valve disease has been improved by accurate diagnosis and assessment of severity by echocardiography and advanced imaging techniques, efforts to elicit symptoms or objective markers of disease severity and progression, and consideration of optimum timing of aortic valve replacement, even in elderly patients. Prevalence of calcific aortic stenosis is growing in ageing populations. Conventional surgery remains the most appropriate option for most patients who require aortic valve replacement, but the transcatheter approach is established for high-risk patients or poor candidates for surgery. The rapid growth of transcatheter aortic valve replacement has been fuelled by improved technology, evidence-based clinical research, and setting up of multidisciplinary heart teams. Aortic regurgitation can be difficult to diagnose and quantify. Left ventricular dysfunction often precedes symptoms, needing active surveillance by echocardiography to determine the optimum time for aortic valve replacement. Development of transcatheter approaches for aortic regurgitation is challenging, owing to the absence of valvular calcification and distortion of aortic root anatomy in many patients.


Asunto(s)
Cardiopatías Congénitas/diagnóstico , Cardiopatías Congénitas/cirugía , Enfermedades de las Válvulas Cardíacas/diagnóstico , Enfermedades de las Válvulas Cardíacas/cirugía , Válvula Aórtica/cirugía , Insuficiencia de la Válvula Aórtica/diagnóstico , Insuficiencia de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico , Estenosis de la Válvula Aórtica/cirugía , Enfermedad de la Válvula Aórtica Bicúspide , Procedimientos Quirúrgicos Cardíacos/métodos , Predicción , Prótesis Valvulares Cardíacas , Humanos , Diseño de Prótesis
6.
Am Heart J ; 184: 97-105, 2017 02.
Artículo en Inglés | MEDLINE | ID: mdl-28224933

RESUMEN

BACKGROUND: The performance of emerging transcatheter aortic valve implantation (TAVI) clinical prediction models (CPMs) in national TAVI cohorts distinct from those where they have been derived is unknown. This study aimed to investigate the performance of the German Aortic Valve, FRANCE-2, OBSERVANT and American College of Cardiology (ACC) TAVI CPMs compared with the performance of historic cardiac CPMs such as the EuroSCORE and STS-PROM, in a large national TAVI registry. METHODS: The calibration and discrimination of each CPM were analyzed in 6676 patients from the UK TAVI registry, as a whole cohort and across several subgroups. Strata included gender, diabetes status, access route, and valve type. Furthermore, the amount of agreement in risk classification between each of the considered CPMs was analyzed at an individual patient level. RESULTS: The observed 30-day mortality rate was 5.4%. In the whole cohort, the majority of CPMs over-estimated the risk of 30-day mortality, although the mean ACC score (5.2%) approximately matched the observed mortality rate. The areas under ROC curve were between 0.57 for OBSERVANT and 0.64 for ACC. Risk classification agreement was low across all models, with Fleiss's kappa values between 0.17 and 0.50. CONCLUSIONS: Although the FRANCE-2 and ACC models outperformed all other CPMs, the performance of current TAVI-CPMs was low when applied to an independent cohort of TAVI patients. Hence, TAVI specific CPMs need to be derived outside populations previously used for model derivation, either by adapting existing CPMs or developing new risk scores in large national registries.


Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Técnicas de Apoyo para la Decisión , Mortalidad , Sistema de Registros , Reemplazo de la Válvula Aórtica Transcatéter , Adulto , Anciano , Anciano de 80 o más Años , Causas de Muerte , Femenino , Humanos , Masculino , Persona de Mediana Edad , Curva ROC , Medición de Riesgo , Reino Unido
7.
Circulation ; 131(13): 1181-90, 2015 Mar 31.
Artículo en Inglés | MEDLINE | ID: mdl-25637628

RESUMEN

BACKGROUND: We assessed trends in the performance of transcatheter aortic valve implantation in the United Kingdom from the first case in 2007 to the end of 2012. We analyzed changes in case mix, complications, outcomes to 6 years, and predictors of mortality. METHODS AND RESULTS: Annual cohorts were examined. Mortality outcomes were analyzed in the 92% of patients from England and Wales for whom independent mortality tracking was available. A total of 3980 transcatheter aortic valve implantation procedures were performed. In successive years, there was an increase in frequency of impaired left ventricular function, but there was no change in Logistic EuroSCORE. Overall 30-day mortality was 6.3%; it was highest in the first cohort (2007-2008), after which there were no further significant changes. One-year survival was 81.7%, falling to 37.3% at 6 years. Discharge by day 5 rose from 16.7% in 2007 and 2008 to 28% in 2012. The only multivariate preprocedural predictor of 30-day mortality was Logistic EuroSCORE ≥40. During long-term follow-up, multivariate predictors of mortality were preprocedural atrial fibrillation, chronic obstructive pulmonary disease, creatinine >200 µmol/L, diabetes mellitus, and coronary artery disease. The strongest independent procedural predictor of long-term mortality was periprocedural stroke (hazard ratio=3.00; P<0.0001). Nonfemoral access and postprocedural aortic regurgitation were also significant predictors of adverse outcome. CONCLUSIONS: We analyzed transcatheter aortic valve implantation in an entire country, with follow-up over 6 years. Although clinical profiles of enrolled patients remained unchanged, longer-term outcomes improved, and patients were discharged earlier. Periprocedural stroke, nonfemoral access, and postprocedural aortic regurgitation are predictors of adverse outcome, along with intrinsic patient risk factors.


Asunto(s)
Reemplazo de la Válvula Aórtica Transcatéter/estadística & datos numéricos , Anciano , Anciano de 80 o más Años , Enfermedades Cardiovasculares/epidemiología , Comorbilidad , Diabetes Mellitus/epidemiología , Grupos Diagnósticos Relacionados , Femenino , Estudios de Seguimiento , Humanos , Estimación de Kaplan-Meier , Enfermedades Renales/epidemiología , Curva de Aprendizaje , Enfermedades Pulmonares/epidemiología , Masculino , Complicaciones Posoperatorias/epidemiología , Pronóstico , Modelos de Riesgos Proporcionales , Recurrencia , Sistema de Registros/estadística & datos numéricos , Factores de Riesgo , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Reemplazo de la Válvula Aórtica Transcatéter/tendencias , Resultado del Tratamiento , Reino Unido/epidemiología
9.
Am J Med Genet A ; 164A(2): 386-91, 2014 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-24311407

RESUMEN

Osteogenesis imperfecta (OI) type I is a hereditary disorder of connective tissue (HDCT) characterized by blue or gray sclerae, variable short stature, dentinogenesis imperfecta, hearing loss, and recurrent fractures from infancy. We present four examples of OI type I complicated by valvular heart disease and associated with tissue fragility. The diagnosis of a type I collagen disorder was confirmed by abnormal COL1A1 or COL1A2 gene sequencing. One patient was investigated with electrophoresis of collagens from cultured skin fibroblasts, showing structurally abnormal collagen type I, skin biopsy showed unusual histology and abnormal collagen fibril ultra-structure at electron microscopy. The combined clinical, surgical, histological, ultra-structural, and molecular genetic data suggest the type I collagen defect as contributory to cardiac valvular disease. The degree of tissue fragility experienced at cardiac surgery in these individuals, also reported in a small number of similar case reports, suggests that patients with OI type I need careful pre-operative assessment and consideration of the risks and benefits of cardiac surgery.


Asunto(s)
Huesos/patología , Colágeno Tipo I/genética , Enfermedades de las Válvulas Cardíacas/etiología , Enfermedades de las Válvulas Cardíacas/patología , Mutación , Osteogénesis Imperfecta/complicaciones , Osteogénesis Imperfecta/genética , Adulto , Niño , Femenino , Enfermedades de las Válvulas Cardíacas/diagnóstico , Ventrículos Cardíacos/patología , Humanos , Inestabilidad de la Articulación/diagnóstico , Inestabilidad de la Articulación/etiología , Masculino , Persona de Mediana Edad , Osteogénesis Imperfecta/diagnóstico , Linaje , Esclerótica/anomalías , Piel/patología , Piel/ultraestructura
10.
J Interv Cardiol ; 27(1): 86-95, 2014 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-24373048

RESUMEN

OBJECTIVES: To determine whether outcomes from transcatheter aortic valve implantation (TAVI) vary according to access route and valve type in a real-world population. BACKGROUND: Registry and uncontrolled trial data have found that patients undergoing nonfemoral TAVI have higher early and late mortality. It is not clear whether worse outcomes relate directly to access route. There have been no direct comparisons of outcomes according to valve type. METHODS: Data were collected prospectively on 1,620 patients undergoing TAVI in the UK and compared in 4 groups: SAPIEN transfemoral (TF); SAPIEN transapical (TA); CoreValve TF, CoreValve subclavian. Univariable and multivariable regression analysis was performed to identify independent predictors of mortality. RESULTS: Mortality in patients undergoing SAPIEN TAVI via a TA approach was higher than with TF at 30 days (11.2% vs. 4.4%, P < 0.01), 1 year (28.7% vs. 18.1%, P = 0.01), and 2 years (56.0% vs. 43.5%, P = 0.01). Logistic EuroSCORE was higher in TA patients (22.5 ± 12.9% vs. 17.7 ± 11.1%, P < 0.0001). After multivariable analysis TA access was associated with increased mortality at 30 days (OR 2.56, 95% CI 1.46-4.48, P < 0.01) and 2 years (OR 1.75, 1.08-2.74, P = 0.02). There was no significant difference in mortality at any time-point between patients treated with SAPIEN (n = 812) and CoreValve (n = 808) prostheses. CoreValve-treated patients had a higher rate of permanent pacemaker implantation (23.1% vs. 7.2%, P < 0.0001), and grade ≥2 aortic regurgitation on postprocedure echocardiography (13.0% vs. 7.3%, P < 0.01). CONCLUSIONS: Patients undergoing TA TAVI experienced increased early and late mortality compared to a TF approach. Survival was not influenced by valve type.


Asunto(s)
Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas/métodos , Anciano , Anciano de 80 o más Años , Cateterismo , Femenino , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Humanos , Masculino , Estudios Prospectivos , Sistema de Registros , Resultado del Tratamiento
11.
JAMA ; 312(2): 162-70, 2014 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-25005653

RESUMEN

IMPORTANCE: Owing to a considerable shift toward bioprosthesis implantation rather than mechanical valves, it is expected that patients will increasingly present with degenerated bioprostheses in the next few years. Transcatheter aortic valve-in-valve implantation is a less invasive approach for patients with structural valve deterioration; however, a comprehensive evaluation of survival after the procedure has not yet been performed. OBJECTIVE: To determine the survival of patients after transcatheter valve-in-valve implantation inside failed surgical bioprosthetic valves. DESIGN, SETTING, AND PARTICIPANTS: Correlates for survival were evaluated using a multinational valve-in-valve registry that included 459 patients with degenerated bioprosthetic valves undergoing valve-in-valve implantation between 2007 and May 2013 in 55 centers (mean age, 77.6 [SD, 9.8] years; 56% men; median Society of Thoracic Surgeons mortality prediction score, 9.8% [interquartile range, 7.7%-16%]). Surgical valves were classified as small (≤21 mm; 29.7%), intermediate (>21 and <25 mm; 39.3%), and large (≥25 mm; 31%). Implanted devices included both balloon- and self-expandable valves. MAIN OUTCOMES AND MEASURES: Survival, stroke, and New York Heart Association functional class. RESULTS: Modes of bioprosthesis failure were stenosis (n = 181 [39.4%]), regurgitation (n = 139 [30.3%]), and combined (n = 139 [30.3%]). The stenosis group had a higher percentage of small valves (37% vs 20.9% and 26.6% in the regurgitation and combined groups, respectively; P = .005). Within 1 month following valve-in-valve implantation, 35 (7.6%) patients died, 8 (1.7%) had major stroke, and 313 (92.6%) of surviving patients had good functional status (New York Heart Association class I/II). The overall 1-year Kaplan-Meier survival rate was 83.2% (95% CI, 80.8%-84.7%; 62 death events; 228 survivors). Patients in the stenosis group had worse 1-year survival (76.6%; 95% CI, 68.9%-83.1%; 34 deaths; 86 survivors) in comparison with the regurgitation group (91.2%; 95% CI, 85.7%-96.7%; 10 deaths; 76 survivors) and the combined group (83.9%; 95% CI, 76.8%-91%; 18 deaths; 66 survivors) (P = .01). Similarly, patients with small valves had worse 1-year survival (74.8% [95% CI, 66.2%-83.4%]; 27 deaths; 57 survivors) vs with intermediate-sized valves (81.8%; 95% CI, 75.3%-88.3%; 26 deaths; 92 survivors) and with large valves (93.3%; 95% CI, 85.7%-96.7%; 7 deaths; 73 survivors) (P = .001). Factors associated with mortality within 1 year included having small surgical bioprosthesis (≤21 mm; hazard ratio, 2.04; 95% CI, 1.14-3.67; P = .02) and baseline stenosis (vs regurgitation; hazard ratio, 3.07; 95% CI, 1.33-7.08; P = .008). CONCLUSIONS AND RELEVANCE: In this registry of patients who underwent transcatheter valve-in-valve implantation for degenerated bioprosthetic aortic valves, overall 1-year survival was 83.2%. Survival was lower among patients with small bioprostheses and those with predominant surgical valve stenosis.


Asunto(s)
Insuficiencia de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Bioprótesis , Implantación de Prótesis de Válvulas Cardíacas/métodos , Adulto , Anciano , Anciano de 80 o más Años , Cateterismo Cardíaco , Femenino , Humanos , Masculino , Persona de Mediana Edad , Diseño de Prótesis , Falla de Prótesis , Sistema de Registros , Análisis de Supervivencia , Resultado del Tratamiento
12.
Circulation ; 126(19): 2335-44, 2012 Nov 06.
Artículo en Inglés | MEDLINE | ID: mdl-23052028

RESUMEN

BACKGROUND: Transcatheter aortic valve-in-valve implantation is an emerging therapeutic alternative for patients with a failed surgical bioprosthesis and may obviate the need for reoperation. We evaluated the clinical results of this technique using a large, worldwide registry. METHODS AND RESULTS: The Global Valve-in-Valve Registry included 202 patients with degenerated bioprosthetic valves (aged 77.7±10.4 years; 52.5% men) from 38 cardiac centers. Bioprosthesis mode of failure was stenosis (n=85; 42%), regurgitation (n=68; 34%), or combined stenosis and regurgitation (n=49; 24%). Implanted devices included CoreValve (n=124) and Edwards SAPIEN (n=78). Procedural success was achieved in 93.1% of cases. Adverse procedural outcomes included initial device malposition in 15.3% of cases and ostial coronary obstruction in 3.5%. After the procedure, valve maximum/mean gradients were 28.4±14.1/15.9±8.6 mm Hg, and 95% of patients had ≤+1 degree of aortic regurgitation. At 30-day follow-up, all-cause mortality was 8.4%, and 84.1% of patients were at New York Heart Association functional class I/II. One-year follow-up was obtained in 87 patients, with 85.8% survival of treated patients. CONCLUSIONS: The valve-in-valve procedure is clinically effective in the vast majority of patients with degenerated bioprosthetic valves. Safety and efficacy concerns include device malposition, ostial coronary obstruction, and high gradients after the procedure.


Asunto(s)
Válvula Aórtica/cirugía , Bioprótesis/efectos adversos , Falla de Equipo/estadística & datos numéricos , Salud Global/estadística & datos numéricos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Prótesis Valvulares Cardíacas/efectos adversos , Sistema de Registros , Anciano , Anciano de 80 o más Años , Insuficiencia de la Válvula Aórtica/epidemiología , Insuficiencia de la Válvula Aórtica/etiología , Insuficiencia de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/epidemiología , Estenosis de la Válvula Aórtica/etiología , Estenosis de la Válvula Aórtica/cirugía , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/métodos , Femenino , Estudios de Seguimiento , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Humanos , Incidencia , Masculino , Reoperación , Estudios Retrospectivos , Resultado del Tratamiento
13.
Catheter Cardiovasc Interv ; 82(2): 328-32, 2013 Aug 01.
Artículo en Inglés | MEDLINE | ID: mdl-22517798

RESUMEN

Balloon predilatation has been regarded as an essential step before implanting the self-expandable prosthesis during transcatheter aortic valve implantation (TAVI). Recent evidence showed that without balloon predilatation, an implantation success rate of >95% could be achieved. We report two cases in which balloon predilatation was not performed initially during TAVI but eventually required it to facilitate device crossing and implantation. They illustrated the importance of case selection and alerted us the potential limitation in performing TAVI without balloon predilatation.


Asunto(s)
Estenosis de la Válvula Aórtica/terapia , Válvula Aórtica/patología , Valvuloplastia con Balón , Calcinosis/terapia , Cateterismo Cardíaco , Implantación de Prótesis de Válvulas Cardíacas/métodos , Anciano , Estenosis de la Válvula Aórtica/diagnóstico , Calcinosis/diagnóstico , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/instrumentación , Femenino , Prótesis Valvulares Cardíacas , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Humanos , Masculino , Selección de Paciente , Diseño de Prótesis , Radiografía Intervencional , Factores de Riesgo , Índice de Severidad de la Enfermedad , Resultado del Tratamiento
14.
J Am Heart Assoc ; 12(4): e027504, 2023 02 21.
Artículo en Inglés | MEDLINE | ID: mdl-36752231

RESUMEN

Background The current standard of care for the treatment of patients with primary mitral regurgitation (MR) is surgical mitral valve repair. Transcatheter edge-to-edge repair with the MitraClip device provides a less invasive treatment option for patients with both primary and secondary MR. Worldwide, >150 000 patients have been treated with the MitraClip device. However, in the United States, MitraClip is approved for use only in primary patients with MR who are at high or prohibitive risk for mitral valve surgery. The REPAIR MR (Percutaneous MitraClip Device or Surgical Mitral Valve Repair in Patients With Primary Mitral Regurgitation Who Are Candidates for Surgery) trial is designed to compare early and late outcomes associated with transcatheter edge-to-edge repair with the MitraClip and surgical repair of primary MR in older or moderate surgical risk patients. Methods and Results The REPAIR MR trial is a prospective, randomized, parallel-controlled, open-label multicenter, noninferiority trial for the treatment of severe primary MR (verified by an independent echocardiographic core laboratory). Patients with severe MR and indications for surgery because of symptoms (New York Heart Association class II-IV), or without symptoms with left ventricular ejection fraction ≤60%, pulmonary artery systolic pressure >50 mm Hg, or left ventricular end-systolic diameter ≥40 mm are eligible for the trial provided they meet the moderate surgical risk criteria as follows: (1) ≥75 years of age, or (2) if <75 years of age, then the subject has a Society of Thoracic Surgeons Predicted Risk Of Mortality score of ≥2% for mitral repair (or Society of Thoracic Surgeons replacement score of ≥4%), or the presence of a comorbidity that may introduce a surgery-specific risk. The local surgeon must determine that the mitral valve can be surgically repaired. Additionally, an independent eligibility committee will confirm that the MR can be reduced to mild or less with both the MitraClip and surgical mitral valve repair with a high degree of certainty. A total of 500 eligible subjects will be randomized in a 1:1 ratio to receive the MitraClip device or to undergo surgical mitral valve repair (control group). There are 2 co-primary end points for the trial, both of which will be evaluated at 2 years. Each subject will be followed for 10 years after enrollment. The study has received approval from both the Food and Drug Administration and the Centers for Medicare and Medicaid Services, and enrolled its first subject in July 2020. Conclusions The REPAIR MR trial will determine the safety and effectiveness of transcatheter edge-to-edge repair with the MitraClip in patients with primary MR who are at moderate surgical risk and are candidates for surgical MV repair. The trial will generate contemporary comparative clinical evidence for the MitraClip device and surgical MV repair. Registration https://clinicaltrials.gov/ct2/show/NCT04198870; NCT04198870.


Asunto(s)
Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Humanos , Anciano , Estados Unidos , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/etiología , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Volumen Sistólico , Estudios Prospectivos , Resultado del Tratamiento , Función Ventricular Izquierda , Medicare , Implantación de Prótesis de Válvulas Cardíacas/métodos , Cateterismo Cardíaco/efectos adversos
15.
Circ J ; 76(10): 2488-93, 2012.
Artículo en Inglés | MEDLINE | ID: mdl-22785461

RESUMEN

BACKGROUND: Percutaneous edge-to-edge mitral valve repair with the MitraClip(®) was shown to be a safe and feasible alternative compared to conventional surgical mitral valve repair. Herein is reported our experience on MitraClip(®) for high-risk surgical candidates with severe mitral regurgitation (MR). METHODS AND RESULTS: Patients with severe MR (3 or 4+) and high operative risk were considered for MitraClip(®) implantation. Device success was defined as placement of 1 or more MitraClips(®) with reduction of MR to ≤2+. Patients were followed up clinically and with echocardiography at 1 year. A total of 27 patients with severe MR (age, 74±12 years; 17 male; logistic EuroSCORE, 27±12; left ventricular ejection fraction, 40±17%) were treated. Fifty-six percent of MR was degenerative and 44% was functional. Device success was 93% with 14 patients receiving 2 clips. MR severity was reduced from 3.5±0.5 to 1.7±0.8 (P<0.001); New York Heart Association class improved from 3.1±0.4 to 2.0±0.8 (P<0.001). In 45% of functional and in 29% of degenerative MR patients, to avoid mitral stenosis, additional MitraClip(®) implantation was not attempted, with resultant transmitral mean gradient of 4.9±1.6mmHg vs. 3.1±1.4mmHg, respectively (P=0.01). CONCLUSIONS: MitraClip(®) was shown to be an effective and safe treatment for patients with both functional and degenerative MR. Inability to obtain a greater reduction of MR was the consequence of borderline transmitral gradient requiring a compromise to avoid mitral stenosis, particularly in the functional MR patients.


Asunto(s)
Procedimientos Quirúrgicos Cardíacos/instrumentación , Procedimientos Quirúrgicos Cardíacos/métodos , Insuficiencia de la Válvula Mitral/cirugía , Válvula Mitral/cirugía , Anciano , Anciano de 80 o más Años , Ecocardiografía , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/fisiopatología , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/fisiopatología , Índice de Severidad de la Enfermedad , Volumen Sistólico
16.
Circ J ; 76(4): 801-8, 2012.
Artículo en Inglés | MEDLINE | ID: mdl-22374149

RESUMEN

MitraClip® therapy is a percutaneous edge-to-edge plication of the mitral leaflets, mimicking the Alfieri surgical technique. MitraClip® implantation is a safe procedure, and survival outcomes in high-surgical-risk patients are superior to historical controls. Despite these results, questions remain concerning long-term efficacy and durability. The MitraClip® device has been studied in a safety and feasibility trial in the USA, a randomized pivotal trial against surgical mitral valve repair. Moreover, MitraClip® now has over 2 years of CE-mark approval and a rapidly expanding clinical experience in Europe, primarily in patients at high risk for surgery. A dedicated multidisciplinary team is necessary, as well as thoughtful patient selection, familiarity with the technical aspects of the procedure, including transesophageal ultrasound imaging and post-procedure monitoring. Currently available clinical data and procedural steps are herein reviewed. Because the MitraClip® procedure is still relatively new, continued investigation is required to further better define the patient populations that will benefit most.


Asunto(s)
Cateterismo Cardíaco/instrumentación , Insuficiencia de la Válvula Mitral/terapia , Válvula Mitral/fisiopatología , Instrumentos Quirúrgicos , Anciano , Cateterismo Cardíaco/efectos adversos , Ecocardiografía Tridimensional , Ecocardiografía Transesofágica , Diseño de Equipo , Medicina Basada en la Evidencia , Femenino , Humanos , Masculino , Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/diagnóstico , Insuficiencia de la Válvula Mitral/fisiopatología , Selección de Paciente , Recuperación de la Función , Medición de Riesgo , Factores de Riesgo , Índice de Severidad de la Enfermedad , Resultado del Tratamiento
18.
J Am Coll Cardiol ; 80(5): 527-544, 2022 08 02.
Artículo en Inglés | MEDLINE | ID: mdl-35902177

RESUMEN

A virtual workshop was organized by the Heart Valve Collaboratory to identify areas of expert consensus, areas of disagreement, and evidence gaps related to bioprosthetic aortic valve hemodynamics. Impaired functional performance of bioprosthetic aortic valve replacement is associated with adverse patient outcomes; however, this assessment is complicated by the lack of standardization for labelling, definitions, and measurement techniques, both after surgical and transcatheter valve replacement. Echocardiography remains the standard assessment methodology because of its ease of performance, widespread availability, ability to do serial measurements over time, and correlation with outcomes. Management of a high gradient after replacement requires integration of the patient's clinical status, physical examination, and multimodality imaging in addition to shared patient decisions regarding treatment options. Future priorities that are underway include efforts to standardize prosthesis sizing and labelling for both surgical and transcatheter valves as well as trials to characterize the consequences of adverse hemodynamics.


Asunto(s)
Estenosis de la Válvula Aórtica , Bioprótesis , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Ecocardiografía , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Hemodinámica , Humanos , Diseño de Prótesis , Falla de Prótesis , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del Tratamiento
19.
Circulation ; 122(9): 861-7, 2010 Aug 31.
Artículo en Inglés | MEDLINE | ID: mdl-20713903

RESUMEN

BACKGROUND: Radial artery (RA) aortocoronary bypass grafts anastomosed to a branch of the circumflex coronary artery have significantly better patency rates than saphenous vein (SV) grafts at 5 years, but the physiological characteristics and mechanisms involved are not clearly defined. We compared RA and SV graft vasomotor and flow responses to endothelium-dependent and -independent stimuli 5 years after surgery in a subgroup of patients enrolled in the Radial artery versus Saphenous Vein Patency (RSVP) trial. METHODS AND RESULTS: Twenty-seven patients were included in the study (RA, n=15; SV, n=12). Graft blood flow was calculated from flow velocity, measured by intracoronary Doppler, and luminal diameter, measured by quantitative coronary angiography, before and after intragraft infusions of adenosine, acetylcholine, and isosorbide dinitrate. At rest, RA luminal diameters were significantly smaller than SV luminal diameters (P=0.029), blood flow velocity was greater in RA than SV (P=0.008), and volume blood flows were similar. RA but not SV dilated in response to adenosine and isosorbide dinitrate (all P<0.05, RA versus SV, percent change from baseline), and there were no significant differences in the diameter responses to acetylcholine. Volume blood flow responses to adenosine, acetylcholine, and isosorbide dinitrate were comparable. CONCLUSIONS: Five years after surgery, RA coronary bypass conduits grafted to a single coronary territory demonstrated preserved flow-mediated vasodilatation, whereas SV grafts did not. Our results may provide insight into the more favorable patency of RA grafts over SV grafts. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov. Unique identifier: NCT00139399.


Asunto(s)
Puente de Arteria Coronaria/métodos , Enfermedad de la Arteria Coronaria/cirugía , Arteria Radial/trasplante , Vena Safena/trasplante , Adenosina , Velocidad del Flujo Sanguíneo/efectos de los fármacos , Velocidad del Flujo Sanguíneo/fisiología , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Endotelio Vascular/fisiología , Estudios de Seguimiento , Humanos , Dinitrato de Isosorbide , Factores de Tiempo , Ultrasonografía Intervencional , Grado de Desobstrucción Vascular/efectos de los fármacos , Grado de Desobstrucción Vascular/fisiología , Resistencia Vascular/efectos de los fármacos , Resistencia Vascular/fisiología , Vasodilatación/efectos de los fármacos , Vasodilatadores
20.
Ann Thorac Surg ; 109(3): 688-694, 2020 03.
Artículo en Inglés | MEDLINE | ID: mdl-31470012

RESUMEN

BACKGROUND: We used a large patient-level data set including 6 angiographic randomized controlled trials (RCTs) on coronary artery bypass conduits to explore incidence and determinants of coronary graft failure. METHODS: Patient-level angiographic data of 6 RCTs comparing long-term outcomes of the radial artery and other conduits were joined. Primary outcome was graft occlusion at maximum follow-up. The analysis was divided as (1) left anterior descending coronary (LAD) distribution and (2) non-LAD distribution (circumflex and right coronary artery). Mixed-model multivariable Cox regression including all baseline characteristics with stratification by individual trials was used to identify predictors of graft occlusion. RESULTS: Included were 1091 patients and 2281 grafts, consisting of 921 left internal mammary arteries, 74 right internal mammary arteries, 710 radial arteries, and 576 saphenous veins. All left internal mammary arteries were used on the LAD, the other conduits were used on the non-LAD distribution. Mean angiographic follow up was 65 ± 29 months. Occlusion rates were 2.3% for the left internal mammary arteries, 13.5% for the left internal mammary arteries, 9.4% for the right internal mammary arteries, and 17.5% for the saphenous veins. At multivariable analysis, type of conduit used, age, female sex, left ventricular ejection fraction of less than 0.50, and use of the Y graft were significantly associated with graft occlusion in the non-LAD distribution. CONCLUSIONS: Our analyses showed that failure of the left internal mammary arteries-to-LAD bypass is a very uncommon event. For the non-LAD distribution, the nonuse of radial artery, age, female sex, left ventricular ejection fraction of less than 0.50, and use of the Y graft configuration were significantly associated with midterm graft failure.


Asunto(s)
Angiografía Coronaria , Puente de Arteria Coronaria , Oclusión de Injerto Vascular/epidemiología , Anciano , Puente de Arteria Coronaria/métodos , Bases de Datos Factuales , Femenino , Humanos , Incidencia , Anastomosis Interna Mamario-Coronaria , Masculino , Arterias Mamarias/trasplante , Persona de Mediana Edad , Arteria Radial/trasplante , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de Riesgo , Vena Safena/trasplante , Volumen Sistólico , Insuficiencia del Tratamiento , Grado de Desobstrucción Vascular
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