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3.
Clin Case Rep ; 11(11): e8052, 2023 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-37927980

RESUMEN

We present a case of a quadriplegic male who developed ventricular fibrillation associated with an anomalous aortic origin of the right coronary artery. Successful revascularization was achieved with percutaneous coronary intervention. This case highlights the application of an unconventional approach to resolve ischemia in a patient with prohibitive surgical risk.

8.
Catheter Cardiovasc Interv ; 97(3): 503-508, 2021 02 15.
Artículo en Inglés | MEDLINE | ID: mdl-32608175

RESUMEN

BACKGROUND: Medical procedures are traditionally taught informally at patients' bedside through observation and practice using the adage "see one, do one, teach one." This lack of formalized training can cause trainees to be unprepared to perform procedures independently. Simulation based education (SBE) increases competence, reduces complications, and decreases costs. We developed, implemented, and evaluated the efficacy of a right heart catheterization (RHC) SBE curriculum. METHODS: The RHC curriculum consisted of a pretest, video didactics, deliberate practice, and a posttest. Pre-and posttest skills examinations consisted of a dichotomous 43-item checklist on RHC skills and a 14-item hemodynamic waveform quiz. We enrolled two groups of fellows: 6 first-year, novice cardiology fellows at Northwestern University in their first month of training, and 11 second- and third-year fellows who had completed traditional required, level I training in RHC. We trained the first-year fellows at the beginning of the 2018-2019 year using the SBE curriculum and compared them to the traditionally-trained cardiology fellows who did not complete SBE. RESULTS: The SBE-trained fellows significantly improved RHC skills, hemodynamic knowledge, and confidence from pre- to posttesting. SBE-trained fellows performed similarly to traditionally-trained fellows on simulated RHC skills checklists (88.4% correct vs. 89.2%, p = .84), hemodynamic quizzes (94.0% correct vs. 86.4%, p = .12), and confidence (79.4 vs. 85.9 out of 100, p = .15) despite less clinical experience. CONCLUSIONS: A SBE curriculum for RHC allowed novice cardiology fellows to achieve level I skills and knowledge at the beginning of fellowship and can train cardiology fellows before patient contact.


Asunto(s)
Cardiología , Competencia Clínica , Cateterismo Cardíaco , Cardiología/educación , Curriculum , Educación de Postgrado en Medicina , Becas , Humanos , Resultado del Tratamiento
9.
J Card Surg ; 36(1): 89-96, 2021 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-33170533

RESUMEN

OBJECTIVE: Surgical reoperation for aortic homograft structural valve degeneration (SVD) is a high-risk procedure. Transcatheter aortic valve replacement (TAVR) for homograft-SVD is an alternative to reoperation, but descriptions of implantation techniques are limited. This study compares outcome in patients undergoing into two groups by the type of previously implanted aortic valve prosthesis: TAVR for failed aortic homografts (TAVR-H) or for stented aortic bioprostheses (TAVR-BP). METHODS: From 2015 to 2017, TAVR was performed in 41 patients with SVD. Thirty-three patients in the TAVR-BP group (six for SVD of valved conduits), and eight patients in the TAVR-H group. The Valve Academic Research Consortium criteria were used for outcome reporting purposes. RESULTS: The patients with TAVR-BP had predominant prosthetic stenosis (94%, p = .002), whereas TAVR-H individuals presented mostly with regurgitation (88%, p = <.001). Patients with TAVR-H received: Sapien-3 (6), Sapien-XT (1), and CoreValve (1) devices. Low, 40% ventricular fixation in relation to homograft annulus was attempted to anchor the prosthesis on the homograft suture-line. One patient with TAVR-BP experienced intraoperative distal prosthesis migration and Type-B aortic dissection, and two patients in the TAVR-H group had late postoperative proximal device migration. In both groups, there was zero 30-day mortality, stroke, or pacemaker implantation. CONCLUSIONS: TAVR for failing aortic homografts may be a feasible and safe alternative to high-risk surgical reintervention. Precise, 40%-ventricular device positioning appears crucial for prevention of late paravalvular leak/late prosthesis migration and minimizing the risk of repeat surgical intervention.


Asunto(s)
Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Aloinjertos , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Humanos , Diseño de Prótesis , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
10.
Am J Cardiol ; 131: 67-73, 2020 09 15.
Artículo en Inglés | MEDLINE | ID: mdl-32723557

RESUMEN

The use of LDT may signify significant hemodynamic changes and left ventricular remodeling in severe aortic stenosis (AS). Therefore, we sought to determine whether loop diuretic therapy (LDT) is associated with adverse outcomes following transcatheter aortic valve implantation (TAVI) in patients with severe symptomatic AS. Subjects undergoing TAVI at a single institution from June 2008 to December 2017 were analyzed. LDT doses were normalized to oral furosemide daily equivalents. All outcomes were adjudicated using VARC2 criteria. Descriptive statistics, multivariate logistic regression, and propensity score matching were used. Of the 804 subjects studied, 48.3% were on pre-TAVI LDT with a mean dose of 51.1 mg furosemide dose-equivalents. Subjects on LDT were higher risk, frail patients with more co-morbidities including chronic kidney disease, coronary artery disease requiring prior bypass grafting, peripheral arterial disease, atrial fibrillation or flutter, and diabetes with more severe heart failure symptoms. Those on LDT also had worse left ventricular systolic function, lower transvalvular gradients, and markers of adverse left ventricular remodeling, including increased left ventricular mass index and higher rates of concentric and eccentric hypertrophy. On propensity-score matching, death within one year post-TAVI was borderline significantly higher in the pre-LDT as compared with no-LDT group (16.9% vs 10.4 %, p = 0.068). In conclusion, use of pre-TAVI LDT for severe symptomatic AS is associated with a trend towards worse 1-year mortality and is a marker of high-risk, frail individuals with advanced left ventricular remodeling.


Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Inhibidores del Simportador de Cloruro Sódico y Cloruro Potásico/uso terapéutico , Reemplazo de la Válvula Aórtica Transcatéter , Remodelación Ventricular/efectos de los fármacos , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/mortalidad , Femenino , Anciano Frágil , Humanos , Masculino , Puntaje de Propensión , Medición de Riesgo , Tasa de Supervivencia
11.
Cardiovasc Revasc Med ; 21(10): 1305-1310, 2020 10.
Artículo en Inglés | MEDLINE | ID: mdl-32192912

RESUMEN

AIMS: Chronic total occlusion (CTO) has been linked to worse survival. While controversial and limited to observational data, successful CTO percutaneous coronary intervention (PCI) has been associated with improved left ventricular (LV) function and mortality. However, the role of CTO PCI prior to transcatheter aortic valve replacement (TAVR) is not clear. We sought to explore the prognostic impact of a pre-TAVR CTO on post-TAVR outcomes. METHODS AND RESULTS: We retrospectively reviewed 783 consecutive TAVR cases performed at a single tertiary care medical center. Pre-TAVR angiograms were analyzed for the presence of a CTO. At the time of TAVR, 12.6% (n = 99) patients had a CTO. At one-year post-TAVR, there was no significant association between the presence of a CTO and death (14.2% vs 13.1%, p = 0.75), functional status, quality of life, or adverse events. There was also no difference in long-term survival (4.1 years vs 4.1 years, p = 0.55). LV ejection fraction was lower in the CTO group at baseline and one year (p < 0.01). CONCLUSIONS: The presence of a CTO did not have any prognostic impact on mortality, change in LV function, or improvement in functional status and angina scores following TAVR in our cohort of elderly, high-risk patients. CTO before TAVR was associated with decreased ejection fraction at baseline and at one year.


Asunto(s)
Estenosis de la Válvula Aórtica , Intervención Coronaria Percutánea , Reemplazo de la Válvula Aórtica Transcatéter , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Humanos , Estudios Observacionales como Asunto , Calidad de Vida , Estudios Retrospectivos , Factores de Riesgo , Resultado del Tratamiento
13.
Innovations (Phila) ; 14(5): 436-444, 2019 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-31671042

RESUMEN

OBJECTIVE: Transcatheter aortic valve replacement is a safe, minimally invasive treatment for severe aortic stenosis in patients with moderate-to-high surgical risk. Monitored anesthesia is administered by an anesthesiologist. This study compares transcatheter aortic valve outcomes under monitored anesthesia vs general anesthesia. METHODS: Data were prospectively collected for 286 patients undergoing transcatheter aortic valve replacement at a single academic hospital from March 2012 to August 2016. The patients were grouped by type of anesthesia: monitored vs general. A propensity score match was performed to compare intraoperative and post-operative outcomes between groups. RESULTS: General anesthesia was used in 102 patients and moderate sedation in 184. Propensity score matching produced 80 pairs. Compared to procedures under general anesthesia, patients receiving monitored anesthesia had shorter procedure (1.6 [1.4, 2.0] vs 2.0 [1.6, 2.5] hours;P < 0.001) and fluoroscopy times (17 [14.5, 22.5] vs 25 [17.9, 30.3] minutes;P < 0.001) and shorter hospital length-of-stay (3 [2.0, 4.0] vs 5 [3.0, 7.0] days;P < 0.001) but no difference in intensive care unit length-of-stay. Blood transfusion was more common in patients undergoing general anesthesia, but there was no difference in stroke, renal failure, postoperative atrial fibrillation, or need for permanent pacemaker. More patients were discharged to home after monitored anesthesia (90% vs 64%;P < 0.001). There was no difference in 30-day mortality (0% vs 3%;P = 0.15). CONCLUSIONS: Transcatheter aortic valve replacement under monitored anesthesia provides the safety of anesthesia-led sedation without intubation and general anesthetic. We found no compromise in patient safety or clinical outcomes.


Asunto(s)
Anestesia General/métodos , Sedación Consciente/métodos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Anciano de 80 o más Años , Anestesia General/mortalidad , Anestesia Intravenosa/métodos , Sedación Consciente/mortalidad , Femenino , Humanos , Estimación de Kaplan-Meier , Masculino , Monitoreo Intraoperatorio/métodos , Puntaje de Propensión , Análisis de Supervivencia , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Resultado del Tratamiento
14.
JAMA Cardiol ; 3(4): 280-287, 2018 04 01.
Artículo en Inglés | MEDLINE | ID: mdl-29490333

RESUMEN

Importance: Prior studies have demonstrated lower all-cause mortality in individuals who are overweight compared with those with normal body mass index (BMI), but whether this may come at the cost of greater burden of cardiovascular disease (CVD) is unknown. Objective: To calculate lifetime risk estimates of incident CVD and subtypes of CVD and to estimate years lived with and without CVD by weight status. Design, Setting, and Participants: In this population-based study, we used pooled individual-level data from adults (baseline age, 20-39, 40-59, and 60-79 years) across 10 large US prospective cohorts, with 3.2 million person-years of follow-up from 1964 to 2015. All participants were free of clinical CVD at baseline with available BMI index and CVD outcomes data. Data were analyzed from October 2016 to July 2017. Exposures: World Health Organization-standardized BMI categories. Main Outcomes and Measures: Total CVD and CVD subtype, including fatal and nonfatal coronary heart disease, stroke, congestive heart failure, and other CVD deaths. Heights and weights were measured directly by investigators in each study, and BMI was calculated as weight in kilograms divided by height in meters squared. We performed (1) modified Kaplan-Meier analysis to estimate lifetime risks, (2) adjusted competing Cox models to estimate joint cumulative risks for CVD or noncardiovascular death, and (3) the Irwin restricted mean to estimate years lived free of and with CVD. Results: Of the 190 672 in-person examinations included in this study, the mean (SD) age was 46.0 (15.0) years for men and 58.7 (12.9) years for women, and 140 835 patients (73.9%) were female. Compared with individuals with a normal BMI (defined as a BMI of 18.5 to 24.9), lifetime risks for incident CVD were higher in middle-aged adults in the overweight and obese groups. Compared with normal weight, among middle-aged men and women, competing hazard ratios for incident CVD were 1.21 (95% CI, 1.14-1.28) and 1.32 (95% CI, 1.24-1.40), respectively, for overweight (BMI, 25.0-29.9), 1.67 (95% CI, 1.55-1.79) and 1.85 (95% CI, 1.72-1.99) for obesity (BMI, 30.0-39.9), and 3.14 (95% CI, 2.48-3.97) and 2.53 (95% CI, 2.20-2.91) for morbid obesity (BMI, ≥40.0). Higher BMI had the strongest association with incident heart failure among CVD subtypes. Average years lived with CVD were longer for middle-aged adults in the overweight and obese groups compared with adults in the normal BMI group. Similar patterns were observed in younger and older adults. Conclusions and Relevance: In this study, obesity was associated with shorter longevity and significantly increased risk of cardiovascular morbidity and mortality compared with normal BMI. Despite similar longevity compared with normal BMI, overweight was associated with significantly increased risk of developing CVD at an earlier age, resulting in a greater proportion of life lived with CVD morbidity.


Asunto(s)
Enfermedades Cardiovasculares/etiología , Obesidad/complicaciones , Sobrepeso/complicaciones , Adulto , Factores de Edad , Anciano , Índice de Masa Corporal , Enfermedades Cardiovasculares/epidemiología , Enfermedades Cardiovasculares/mortalidad , Femenino , Humanos , Longevidad , Masculino , Persona de Mediana Edad , Factores de Riesgo , Factores Sexuales , Adulto Joven
15.
Catheter Cardiovasc Interv ; 91(6): 1054-1059, 2018 05 01.
Artículo en Inglés | MEDLINE | ID: mdl-28766876

RESUMEN

OBJECTIVES: The aim of this study is to determine whether simulation-based education (SBE) translates into reduced procedure time, radiation, and contrast use in actual clinical care. BACKGROUND: As a high volume procedure often performed by novice cardiology fellows, diagnostic coronary angiography represents an excellent target for SBE. Reports of SBE in interventional cardiology are limited and there is little understanding of the potential downstream clinical impact of these interventions. METHODS: All diagnostic coronary angiograms performed at a single center between January 1, 2011 and June 30, 2015 were analyzed. Random effects linear regression models were used to compare outcomes between procedures performed by 12 cardiology fellows who underwent simulation-based training and those performed by 20 traditionally trained fellows. RESULTS: Thirty-two cardiology fellows performed 2,783 diagnostic coronary angiograms. Procedures performed by fellows trained with SBE were shorter (mean of 23.98 min vs. 24.94 min, P = 0.034) and were performed with decreased radiation (mean of 56,348 mGycm2 vs. 66,120 mGycm2 , P < 0.001). After controlling for year in training, procedure year, access site, and supervising attending physician, training on the simulator was independently associated with 117 fewer seconds of fluoroscopy time per procedure (P = 0.04). CONCLUSIONS: Diagnostic coronary angiography SBE is associated with decreased use of fluoroscopy in downstream clinical care. SBE may be a useful tool to reduce radiation exposure in the cardiac catheterization laboratory.


Asunto(s)
Cardiólogos/educación , Cardiología/educación , Angiografía Coronaria , Educación de Postgrado en Medicina/métodos , Internado y Residencia , Entrenamiento Simulado/métodos , Competencia Clínica , Angiografía Coronaria/efectos adversos , Fluoroscopía , Humanos , Seguridad del Paciente , Dosis de Radiación , Exposición a la Radiación/efectos adversos , Exposición a la Radiación/prevención & control , Análisis y Desempeño de Tareas , Factores de Tiempo
16.
Am J Cardiol ; 119(11): 1832-1838, 2017 06 01.
Artículo en Inglés | MEDLINE | ID: mdl-28395888

RESUMEN

Statin therapy is associated with improved survival in patients at high risk for cardiovascular mortality, but the impact of statin therapy in patients treated with transcatheter aortic valve replacement (TAVR) is unknown. We reviewed 294 consecutive cases of TAVR performed at a single tertiary care medical center. We defined high-intensity statin therapy as atorvastatin 40 to 80 mg/day or rosuvastatin 20 to 40 mg/day. Study outcomes included post-TAVR adverse events, 30-day mortality, and overall survival. At the time of TAVR, 14% (n = 41) were on high-intensity statin therapy, 59% (n = 173) were on low- or moderate-intensity statin therapy, and 27% (n = 80) were not on statin therapy. There was no association between statin therapy and the rate of post-TAVR stroke, myocardial infarction, acute kidney injury, in-hospital mortality, or 30-day mortality. At 2 years, 83% of patients in the high-intensity statin group were alive, 70% in the low/moderate-intensity statin group were alive, and 57% in the no statin group were alive (log-rank p = 0.016). In a risk-adjusted model, high-intensity statin therapy was associated with a 64% reduction in all-cause mortality (hazard ratio 0.36, 95% CI 0.14 to 0.90, p = 0.029) compared with no statin therapy. In conclusion, statin therapy is associated with improved overall survival after TAVR in a dose-dependent manner.


Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Prótesis Valvulares Cardíacas , Inhibidores de Hidroximetilglutaril-CoA Reductasas/administración & dosificación , Complicaciones Posoperatorias/prevención & control , Sistema de Registros , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/mortalidad , Causas de Muerte/tendencias , Relación Dosis-Respuesta a Droga , Femenino , Estudios de Seguimiento , Mortalidad Hospitalaria/tendencias , Humanos , Incidencia , Masculino , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos , Factores de Riesgo , Tasa de Supervivencia/tendencias , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos/epidemiología
17.
J Am Soc Echocardiogr ; 30(6): 541-551, 2017 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-28314622

RESUMEN

BACKGROUND: Little is known about baseline diastolic dysfunction and changes in diastolic dysfunction grade after transcatheter aortic valve replacement (TAVR) for aortic stenosis (AS) and its impact on overall outcomes. The aim of this study was to describe baseline diastolic dysfunction and changes in diastolic dysfunction grade that occur with TAVR and their relationship to mortality and rehospitalization. METHODS: This was a single-center study evaluating all TAVRs from January 2012 to June 2014. We compared parameters of diastolic dysfunction grade on pre-TAVR and 1 month post-TAVR echocardiograms for all patients undergoing the procedure. Descriptive statistics, Kaplan-Meier time-to-event analysis, and multivariate logistic regression were used. RESULTS: Of a sample size of 120 patients undergoing TAVR for symptomatic severe AS, 90 were included in the final analysis after excluding significant mitral valve disease. There were improvements in individual parameters of diastolic dysfunction grade such as lateral e' velocity, E/lateral e', and left atrial volume index (nonsignificant trend) in the setting of improvement in aortic valve area and gradients and functional class pre- and post-TAVR. Multivariate analysis revealed that baseline diastolic dysfunction grade, but not post-TAVR or changes in diastolic dysfunction grade, was associated with 1-year death (hazard ratio, 1.163; 95% CI, 1.049-1.277, P = .005) and combined death/cardiovascular hospitalization (hazard ratio, 1.174; 95% CI, 1.032-1.318; P = .018). CONCLUSIONS: In this single-center retrospective study of patients with symptomatic severe AS who underwent TAVR, several diastolic function parameters improved on echocardiography, but baseline diastolic dysfunction grade remained the most important echocardiographic factor associated with adverse 1-year outcomes.


Asunto(s)
Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/cirugía , Readmisión del Paciente/estadística & datos numéricos , Complicaciones Posoperatorias/mortalidad , Volumen Sistólico , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Disfunción Ventricular Izquierda/mortalidad , Adolescente , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Causalidad , Chicago/epidemiología , Comorbilidad , Ecocardiografía/estadística & datos numéricos , Femenino , Humanos , Incidencia , Estudios Longitudinales , Masculino , Complicaciones Posoperatorias/diagnóstico por imagen , Estudios Retrospectivos , Factores de Riesgo , Tasa de Supervivencia , Reemplazo de la Válvula Aórtica Transcatéter/estadística & datos numéricos , Resultado del Tratamiento , Disfunción Ventricular Izquierda/diagnóstico por imagen , Disfunción Ventricular Izquierda/prevención & control
18.
Catheter Cardiovasc Interv ; 89(5): 860-865, 2017 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-27468705

RESUMEN

OBJECTIVES: We studied the impact of operator experience on trans-radial (TR) cardiac catheterization performance in contemporary practice. BACKGROUND: TR cardiac catheterization offers advantages over trans-femoral (TF) cardiac catheterization, but the TR approach has been slowly adopted in the United States. METHODS: We reviewed all cases of attempted TR cardiac catheterization at a single tertiary care medical center from May 2008 until April 2015. We classified the attending operator TR case experience at the time of each case, and the control group constituted cases performed by operators with >300 TR cases. Study endpoints were TR cannulation failure, TF cross-over, contrast medium dose, and fluoroscopy time. RESULTS: Over the study period, 4177 attempted TR cardiac catheterization cases were performed. The percentage of TR cases performed with percutaneous coronary intervention (PCI) increased from 14.0% in 2009 to 30.2% in 2015 (P-trend <0.001). The rate of TR cannulation failure decreased from 4.3% in 2009 to 2.0% in 2015 (P-trend = 0.071), and the rate of TF cross-over decreased from 4.3% in 2009 to 3.2% in 2015 (P-trend = 0.034). Operators with over 100 cases had the lowest odds of TR cannulation failure, while operators with over 200 cases had the lowest odds of TF cross-over. Operators with over 200 cases used the lowest mean contrast medium dose and mean fluoroscopy time. CONCLUSIONS: Increasing operator TR experience is associated with lower odds of TR cannulation failure and TF cross-over, as well as lower contrast medium dose and fluoroscopy time. © 2016 Wiley Periodicals, Inc.


Asunto(s)
Cateterismo Cardíaco/métodos , Cardiología/educación , Competencia Clínica , Enfermedad de la Arteria Coronaria/diagnóstico , Educación Médica Continua/métodos , Intervención Coronaria Percutánea/educación , Enfermedad de la Arteria Coronaria/cirugía , Femenino , Estudios de Seguimiento , Humanos , Curva de Aprendizaje , Masculino , Persona de Mediana Edad , Arteria Radial , Estudios Retrospectivos , Factores de Tiempo
19.
Catheter Cardiovasc Interv ; 89(7): 1286-1291, 2017 Jun 01.
Artículo en Inglés | MEDLINE | ID: mdl-27566989

RESUMEN

OBJECTIVES: We assessed whether post-operative delirium is associated with healthcare utilization and overall survival after trans-catheter aortic valve replacement. BACKGROUND: Delirium, a common syndrome among hospitalized older adults, is associated with increased morbidity and mortality. METHODS: We reviewed 294 transcatheter aortic valve replacement cases between June 2008 and February 2015 at a tertiary care academic medical center. Post-operative delirium was identified by confusion assessment method screening and clinician diagnosis. RESULTS: Delirium was identified in 61 patients (21%). Non-femoral access for trans-catheter aortic valve replacement was more common in delirious patients than in non-delirious patients (41% vs. 27%, P = 0.04). Delirious patients had diminished overall survival after trans-catheter aortic valve replacement compared to non-delirious patients (1-year survival 59% vs. 84%, log-rank P = 0.002). After adjusting for age, Society of Thoracic Surgeons predicted 30-day mortality, and access type; delirium remained independently associated with diminished overall survival (hazard ratio 2.01, 95% confidence interval 1.21-3.33, P = 0.007). The delirium group had longer mean hospital stay (13.3 ± 9.5 days vs. 6.7 ± 3.8 days, P < 0.001) and a higher rate of discharge to a rehabilitation facility (61% vs. 27%, P < 0.001), but there was no difference in 30-day hospital re-admission rates or 30-day mortality based on delirium status. CONCLUSIONS: Delirium occurs in one out of five patients after trans-catheter aortic valve replacement and is associated with diminished survival and increased healthcare utilization. Further studies are needed to clarify whether strategies aimed at reducing delirium after trans-catheter aortic valve replacement may improve outcomes in this high-risk subset. © 2016 Wiley Periodicals, Inc.


Asunto(s)
Delirio/terapia , Recursos en Salud/estadística & datos numéricos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Anciano , Anciano de 80 o más Años , Delirio/diagnóstico , Delirio/etiología , Delirio/mortalidad , Femenino , Humanos , Tiempo de Internación , Masculino , Alta del Paciente , Modelos de Riesgos Proporcionales , Centros de Rehabilitación , Estudios Retrospectivos , Factores de Riesgo , Centros de Atención Terciaria , Factores de Tiempo , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Resultado del Tratamiento
20.
JAMA Cardiol ; 1(2): 163-71, 2016 05 01.
Artículo en Inglés | MEDLINE | ID: mdl-27437887

RESUMEN

IMPORTANCE: Gene transfer has rarely been tested in randomized clinical trials. OBJECTIVE: To evaluate the safety and efficacy of intracoronary delivery of adenovirus 5 encoding adenylyl cyclase 6 (Ad5.hAC6) in heart failure. DESIGN, SETTING, AND PARTICIPANTS: A randomized, double-blind, placebo-controlled, phase 2 clinical trial was conducted in US medical centers (randomization occurred from July 19, 2010, to October 30, 2014). Participants 18 to 80 years with symptomatic heart failure (ischemic and nonischemic) and an ejection fraction (EF) of 40% or less were screened; 86 individuals were enrolled, and 56 were randomized. Data analysis was of the intention-to-treat population. Participants underwent exercise testing and measurement of left ventricular EF (echocardiography) and then cardiac catheterization, where left ventricular pressure development (+dP/dt) and decline (-dP/dt) were recorded. Participants were randomized (3:1 ratio) to receive 1 of 5 doses of intracoronary Ad5.hAC6 or placebo. Participants underwent a second catheterization 4 weeks later for measurement of dP/dt. Exercise testing and EF were assessed 4 and 12 weeks after randomization. INTERVENTIONS: Intracoronary administration of Ad5.hAC6 (3.2 × 109 to 1012 virus particles) or placebo. MAIN OUTCOMES AND MEASURES: Primary end points included exercise duration and EF before and 4 and 12 weeks after randomization and peak rates of +dP/dt and -dP/dt before and 4 weeks after randomization. Fourteen placebo participants were compared (intention to treat) with 24 Ad5.hAC6 participants receiving the highest 2 doses (D4 + 5). RESULTS: Fifty-six individuals were randomized and monitored for up to 1 year. Forty-two participants (75%) received Ad5.hAC6 (mean [SE] age, 63 [1] years; EF, 30% [1%]), and 14 individuals (25%) received placebo (age, 62 [1] years; EF, 30% [2%]). Exercise duration showed no significant group differences (4 weeks, P = .27; 12 weeks, P = .47, respectively). The D4 + 5 participants had increased EF at 4 weeks (+6.0 [1.7] EF units; n = 21; P < .004), but not 12 weeks (+3.0 [2.4] EF units; n = 21; P = .16). Placebo participants showed no increase in EF at 4 weeks or 12 weeks. Exercise duration showed no between-group differences (4-week change from baseline: placebo, 27 [36] seconds; D4 + 5, 44 [25] seconds; P = .27; 12-week change from baseline: placebo, 44 [28] seconds; D4 + 5, 58 [29 seconds, P = .47). AC6 gene transfer increased basal left ventricular peak -dP/dt (4-week change from baseline: placebo, +93 [51] mm Hg/s; D4 + 5, -39 [33] mm Hg/s; placebo [n = 21]; P < .03); AC6 did not increase arrhythmias. The admission rate for patients with heart failure was 9.5% (4 of 42) in the AC6 group and 28.6% (4 of 14) in the placebo group (relative risk, 0.33 [95% CI, 0.08-1.36]; P = .10). CONCLUSIONS AND RELEVANCE: AC6 gene transfer safely increased LV function beyond standard heart failure therapy, attainable with one-time administration. Larger trials are warranted. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00787059.


Asunto(s)
Adenoviridae/genética , Adenilil Ciclasas/administración & dosificación , Técnicas de Transferencia de Gen/tendencias , Terapia Genética/métodos , Insuficiencia Cardíaca/diagnóstico , Volumen Sistólico/efectos de los fármacos , Función Ventricular Izquierda/efectos de los fármacos , Adenilil Ciclasas/uso terapéutico , Anciano , Cateterismo Cardíaco/métodos , Ecocardiografía , Prueba de Esfuerzo/métodos , Femenino , Insuficiencia Cardíaca/diagnóstico por imagen , Insuficiencia Cardíaca/genética , Insuficiencia Cardíaca/fisiopatología , Insuficiencia Cardíaca/terapia , Humanos , Masculino , Persona de Mediana Edad , Admisión del Paciente/estadística & datos numéricos , Resultado del Tratamiento , Estados Unidos/epidemiología
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