RESUMEN
SOURCE CITATION: Sorajja P, Whisenant B, Hamid N, et al; TRILUMINATE Pivotal Investigators. Transcatheter repair for patients with tricuspid regurgitation. N Engl J Med. 4 Mar 2023. [Epub ahead of print]. 36876753.
Asunto(s)
Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Tricúspide , Humanos , Insuficiencia de la Válvula Tricúspide/cirugía , Resultado del Tratamiento , Calidad de Vida , Cateterismo CardíacoRESUMEN
BACKGROUND: There are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aortic-valve replacement in patients with severe aortic stenosis and intermediate surgical risk. METHODS: We enrolled 2032 intermediate-risk patients with severe, symptomatic aortic stenosis at 57 centers. Patients were stratified according to intended transfemoral or transthoracic access (76.3% and 23.7%, respectively) and were randomly assigned to undergo either TAVR or surgical replacement. Clinical, echocardiographic, and health-status outcomes were followed for 5 years. The primary end point was death from any cause or disabling stroke. RESULTS: At 5 years, there was no significant difference in the incidence of death from any cause or disabling stroke between the TAVR group and the surgery group (47.9% and 43.4%, respectively; hazard ratio, 1.09; 95% confidence interval [CI], 0.95 to 1.25; P = 0.21). Results were similar for the transfemoral-access cohort (44.5% and 42.0%, respectively; hazard ratio, 1.02; 95% CI, 0.87 to 1.20), but the incidence of death or disabling stroke was higher after TAVR than after surgery in the transthoracic-access cohort (59.3% vs. 48.3%; hazard ratio, 1.32; 95% CI, 1.02 to 1.71). At 5 years, more patients in the TAVR group than in the surgery group had at least mild paravalvular aortic regurgitation (33.3% vs. 6.3%). Repeat hospitalizations were more frequent after TAVR than after surgery (33.3% vs. 25.2%), as were aortic-valve reinterventions (3.2% vs. 0.8%). Improvement in health status at 5 years was similar for TAVR and surgery. CONCLUSIONS: Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.).
Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas/métodos , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Insuficiencia de la Válvula Aórtica/etiología , Insuficiencia de la Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/complicaciones , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/mortalidad , Estudios de Cohortes , Ecocardiografía , Femenino , Estado de Salud , Humanos , Incidencia , Análisis de Intención de Tratar , Estimación de Kaplan-Meier , Masculino , Análisis Multivariante , Complicaciones Posoperatorias/mortalidad , Factores de Riesgo , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/etiología , Resultado del TratamientoRESUMEN
OBJECTIVE: To describe outcomes of patients who underwent transcatheter aortic valve replacement (TAVR) in a native valve or failed bioprosthetic valve or transcatheter heart valve (THV) and a transcatheter mitral valve replacement procedure (TMVR; valve-in-valve [mViV], valve-in-ring [mViR], and valve in mitral annulus calcification [ViMAC]) either concomitantly (same procedure) or staged (different procedures). BACKGROUND: Patient characteristics, procedural details, and outcomes of concomitant or staged TAVR and TMVR procedures are largely unknown. METHODS: Data were extracted from the STS/ACC TVT Registry™ for patients undergoing concomitant or staged TAVR and TMVR with SAPIEN XT, SAPIEN 3, or SAPIEN 3 Ultra (Edwards Lifesciences) THVs. Descriptive results were reported for procedural, index hospitalization, 30-day, and 1-year outcomes. RESULTS: A total of 257 patients underwent TAVR and TMVR in concomitant (n = 135) or staged (n = 122) procedures. Device success was 82.9% and 83.9% for concomitant TAVR and TMVR procedures and 83.8% and 82.5% for staged TAVR and TMVR procedures. Significant improvements in aortic and mitral valve function remained stable through 1 year. All-cause mortality for concomitant and staged groups was 14.7% and 10.5% at 30 days, and 32.8% and 24.6% at 1 year, respectively. Stroke rate for concomitant and staged groups was 0.8% and 3.6% at 30 days and 3.9% and 5.6% at 1 year, respectively. Improvements from baseline to 1 year in NYHA class and KCCQ overall summary scores were observed for all patients. CONCLUSIONS: Concomitant or staged transcatheter treatment of patients with aortic and mitral valve disease can be performed in select high-risk patients in experienced centers.
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Estenosis de la Válvula Aórtica , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Diseño de Prótesis , Resultado del Tratamiento , Factores de Tiempo , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugíaRESUMEN
BACKGROUND: Previous trials have shown that among high-risk patients with aortic stenosis, survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. We evaluated the two procedures in a randomized trial involving intermediate-risk patients. METHODS: We randomly assigned 2032 intermediate-risk patients with severe aortic stenosis, at 57 centers, to undergo either TAVR or surgical replacement. The primary end point was death from any cause or disabling stroke at 2 years. The primary hypothesis was that TAVR would not be inferior to surgical replacement. Before randomization, patients were entered into one of two cohorts on the basis of clinical and imaging findings; 76.3% of the patients were included in the transfemoral-access cohort and 23.7% in the transthoracic-access cohort. RESULTS: The rate of death from any cause or disabling stroke was similar in the TAVR group and the surgery group (P=0.001 for noninferiority). At 2 years, the Kaplan-Meier event rates were 19.3% in the TAVR group and 21.1% in the surgery group (hazard ratio in the TAVR group, 0.89; 95% confidence interval [CI], 0.73 to 1.09; P=0.25). In the transfemoral-access cohort, TAVR resulted in a lower rate of death or disabling stroke than surgery (hazard ratio, 0.79; 95% CI, 0.62 to 1.00; P=0.05), whereas in the transthoracic-access cohort, outcomes were similar in the two groups. TAVR resulted in larger aortic-valve areas than did surgery and also resulted in lower rates of acute kidney injury, severe bleeding, and new-onset atrial fibrillation; surgery resulted in fewer major vascular complications and less paravalvular aortic regurgitation. CONCLUSIONS: In intermediate-risk patients, TAVR was similar to surgical aortic-valve replacement with respect to the primary end point of death or disabling stroke. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.).
Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas/métodos , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/mortalidad , Femenino , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Humanos , Estimación de Kaplan-Meier , Masculino , Análisis Multivariante , Complicaciones Posoperatorias/mortalidad , Factores de Riesgo , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/mortalidad , UltrasonografíaRESUMEN
The development of transcatheter interventions to provide a minimally invasive alternative to open surgical repair has revolutionized the care of patients with valvular heart disease. Recently, this technology has been expanded to allow for the treatment of pathology of the mitral valve. This review discusses the anesthetic considerations for patients presenting for transcatheter management of mitral valve disease, including transcatheter mitral valve replacement (TMVR) and transcatheter mitral valve repair (TMVRep). The initial focus is on the current literature on transcatheter interventions for mitral valve pathologies as well as current and developing technology for TMVR and TMVRep. The authors' institutional experience with anesthetic management for the TMVR and TMVRep procedures is described, including potential pitfalls and complications, concluding with a discussion of the role of transesophageal echocardiography in the care of this patient population.
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Anestesia/métodos , Anestésicos/administración & dosificación , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Cateterismo Cardíaco/métodos , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Anestesia/normas , Anestésicos/normas , Estenosis de la Válvula Aórtica/tratamiento farmacológico , Estenosis de la Válvula Aórtica/cirugía , Cateterismo Cardíaco/normas , Prótesis Valvulares Cardíacas/normas , Humanos , Insuficiencia de la Válvula Mitral/tratamiento farmacológico , Insuficiencia de la Válvula Mitral/cirugíaRESUMEN
Aims: In patients randomized to transcatheter or surgical aortic valve replacement (TAVR, SAVR), we sought to determine whether SAVR is associated with worsening right ventricular (RV) function and whether RV deterioration is associated with mortality. Methods and results: In 1376 patients from PARTNERIIA with paired baseline and 30-day core lab echocardiograms, worsening RV function was defined as decline by at least one grade from baseline to 30 days. Our primary outcome was all-cause mortality from 30 days to 2 years. Among 744 patients with TAVR, 62 (8.3%) had worsening RV function, compared with 156 of 632 patients with SAVR (24.7%) (P < 0.0001). In a multivariable model, SAVR [odds ratio (OR) 4.05, 95% confidence interval (CI) 2.55-6.44], a dilated RV (OR 2.38, 95% CI 1.37-4.14), and more than mild tricuspid regurgitation (TR) (OR 2.58, 95% CI 1.25-5.33) were associated with worsening RV function. There were 169 deaths, and patients with worsening RV function had higher all-cause mortality [hazard ratio (HR) 1.98, 95% CI 1.40-2.79]. This association remained robust after adjusting for clinical and echocardiographic variables. Among patients with worsening RV function, there was no mortality difference between TAVR and SAVR (HR 1.16, 95% CI 0.61-2.18). The development of moderate or severe RV dysfunction from baseline normal RV function conferred the worst prognosis (HR 2.87, 95% CI 1.40-5.89). Conclusion: After aortic valve replacement, worsening RV function is more common in patients with baseline RV dilation, more than mild TR, and in patients treated with SAVR. Worsening RV function and the magnitude of deterioration have important prognostic implications.
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Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas/métodos , Complicaciones Posoperatorias/epidemiología , Disfunción Ventricular Derecha/epidemiología , Anciano de 80 o más Años , Progresión de la Enfermedad , Femenino , Humanos , Incidencia , Masculino , Complicaciones Posoperatorias/mortalidad , Pronóstico , Estudios Prospectivos , Reemplazo de la Válvula Aórtica Transcatéter , Disfunción Ventricular Derecha/mortalidadRESUMEN
Pulmonary valve replacement (PVR) is indicated in patients with significant pulmonary regurgitation (PR), stenosis (PS), or mixed pulmonary valve disease. While once an exclusively surgical procedure, many patients can undergo transcatheter PVR (TPVR) with excellent early outcomes (Haas et al. 2013, Clin. Res. Cardiol. Off. J. German Cardiac Soc. 102:119-128; Kenny et al. 2011, J. Am. Coll. Cardiol. 58:2248-2256; Cheatham et al. Circulation 2015, 131:1960-1970). The available transcatheter options continue to expand, but the majority of cases performed in the United States involve the use of FDA approved Melody valve (Medtronic; Minneapolis, MN) or the SAPIEN (Edwards Lifesciences; Irvine, CA) family of valves. The SAPIEN 3 valve (S3) recently received FDA approval for transcatheter aortic valve replacement. We report the first S3 implantation in the pulmonary position for treatment of chronic pulmonary regurgitation and progressive right ventricular dilation in an 18 year old male with repaired Tetralogy of Fallot. © 2016 Wiley Periodicals, Inc.
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Cateterismo Cardíaco/instrumentación , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Prótesis Valvulares Cardíacas , Insuficiencia de la Válvula Pulmonar/terapia , Tetralogía de Fallot/cirugía , Obstrucción del Flujo Ventricular Externo/terapia , Adolescente , Cateterismo Cardíaco/métodos , Enfermedad Crónica , Implantación de Prótesis de Válvulas Cardíacas/métodos , Humanos , Masculino , Diseño de Prótesis , Insuficiencia de la Válvula Pulmonar/diagnóstico por imagen , Insuficiencia de la Válvula Pulmonar/etiología , Índice de Severidad de la Enfermedad , Resultado del Tratamiento , Obstrucción del Flujo Ventricular Externo/diagnóstico por imagen , Obstrucción del Flujo Ventricular Externo/etiologíaRESUMEN
OBJECTIVES: To evaluate the long-term outcomes of patients with ostial lesions who underwent percutaneous coronary intervention (PCI) with and without the use of intravascular ultrasound (IVUS). BACKGROUND: A higher rate of adverse cardiac events is associated with PCI of ostial lesions as compared with nonostial disease. METHODS: From 7/2002 to 8/2010, 225 patients with 233 coronary ostial lesions underwent PCI with (n = 82) and without (n = 143) IVUS guidance. Ostial lesions included both native aorto-ostial or major coronary vessel (left anterior descending, left circumflex, and ramus intermedius) lesions. Clinical outcomes [cardiovascular death, myocardial infarction (MI), and target lesion revascularization (TLR)] at a mean follow-up of 4.2 ± 2.5 years were compared between patients undergoing PCI of an ostial lesion with and without use of IVUS using univariate and propensity score adjusted analyses. RESULTS: Aorto-ostial lesions (n = 109) comprised 47% of lesions, whereas the remaining lesions (53%) involved major coronary vessels. After propensity score adjustment, IVUS use was associated with lower rates of the composite of cardiovascular death, MI, or TLR (HR 0.54, 95% CI 0.29-0.99; P = 0.04), composite MI or TLR (HR 0.39, 95% CI 0.18-0.83; P = 0.01), and MI (HR 0.31, 95% CI 0.11-0.85; P = 0.02) as compared with no IVUS. The use of IVUS was also associated with a trend towards a lower rate of TLR (HR 0.42, 95% CI 0.17-1.02; P = 0.06). CONCLUSIONS: PCI of coronary ostial lesions with the use of IVUS was associated with significantly lower rates of adverse cardiac events.
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Enfermedad de la Arteria Coronaria/terapia , Intervención Coronaria Percutánea/métodos , Ultrasonografía Intervencional/métodos , Anciano , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/mortalidad , Femenino , Humanos , Estimación de Kaplan-Meier , Modelos Logísticos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Infarto del Miocardio/etiología , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Puntaje de Propensión , Modelos de Riesgos Proporcionales , Factores Protectores , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Ultrasonografía Intervencional/efectos adversos , Ultrasonografía Intervencional/mortalidadRESUMEN
AIMS: Although lesions deferred revascularization following fractional flow reserve (FFR) assessment have a low risk of adverse cardiac events, variability in risk for deferred lesion intervention (DLI) has not been previously evaluated. The aim of this study was to develop a prediction model to estimate 1-year risk of DLI for coronary lesions where revascularization was not performed following FFR assessment. METHODS AND RESULTS: A prediction model for DLI was developed from a cohort of 721 patients with 882 coronary lesions where revascularization was deferred based on FFR between 10/2002 and 7/2010. Deferred lesion intervention was defined as any revascularization of a lesion previously deferred following FFR. The final DLI model was developed using stepwise Cox regression and validated using bootstrapping techniques. An algorithm was constructed to predict the 1-year risk of DLI. During a mean (±SD) follow-up period of 4.0 ± 2.3 years, 18% of lesions deferred after FFR underwent DLI; the 1-year incidence of DLI was 5.3%, while the predicted risk of DLI varied from 1 to 40%. The final Cox model included the FFR value, age, current or former smoking, history of coronary artery disease (CAD) or prior percutaneous coronary intervention, multi-vessel CAD, and serum creatinine. The c statistic for the DLI prediction model was 0.66 (95% confidence interval, CI: 0.61-0.70). CONCLUSION: Patients deferred revascularization based on FFR have variation in their risk for DLI. A clinical prediction model consisting of five clinical variables and the FFR value can help predict the risk of DLI in the first year following FFR assessment.
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Enfermedad de la Arteria Coronaria/terapia , Revascularización Miocárdica , Estudios de Cohortes , Puente de Arteria Coronaria , Enfermedad de la Arteria Coronaria/fisiopatología , Reserva del Flujo Fraccional Miocárdico/fisiología , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea , Medición de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
AIM: The impact of paravalvular regurgitation (PVR) following transcatheter aortic valve replacement (TAVR) remains uncertain. In this analysis, we sought to evaluate the impact of varying degrees of PVR on both mortality and changes in ventricular geometry and function. METHODS AND RESULTS: Clinical and echocardiographic outcomes of patients who underwent TAVR from the randomized cohorts and continued access registries in the PARTNER trial were analysed after stratifying by severity of post-implant PVR, which was graded as none/trace in 52.9% (n = 1288), mild in 38.0% (n = 925), and moderate/severe in 9.1% (n = 221). There were significant differences in baseline clinical and echocardiographic characteristics. After TAVR, all the patients demonstrated increase in left ventricular (LV) function and reduction in the LV mass index, although the magnitude of mass regression was lower in the moderate/severe PVR group. The 30-day mortality (3.1 vs. 3.4 vs. 4.5%, P = 0.56) and stroke (3.4 vs. 3.7 vs. 2.3%, P = 0.59) were similar in all groups (none/trace, mild, and moderate/severe). At 1 year, there was increased all-cause mortality (15.9 vs. 22.2 vs. 35.1%, P < 0.0001), cardiac mortality (6.1 vs. 7.4% vs. 16.3%, P < 0.0001) and re-hospitalization (14.4 vs. 23.0 vs. 31.3%, P < 0.0001) with worsening PVR. A multivariable analysis indicated that the presence of moderate/severe PVR (HR: 2.18, 95% CI: 1.57-3.02, P < 0.0001) or mild PVR (HR: 1.37, 95% CI: 1.14-1.90, P = 0.012) was associated with higher late mortality. CONCLUSION: Differences in baseline characteristics in patients with increasing severities of PVR may increase the risk of this complication. Despite these differences, multivariable analysis demonstrated that both mild and moderate/severe PVR predicted higher 1-year mortality.
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Estenosis de la Válvula Aórtica/cirugía , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Anciano de 80 o más Años , Insuficiencia de la Válvula Aórtica/etiología , Insuficiencia de la Válvula Aórtica/mortalidad , Insuficiencia de la Válvula Aórtica/patología , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/patología , Ecocardiografía , Femenino , Prolapso de las Válvulas Cardíacas , Humanos , Masculino , Insuficiencia de la Válvula Mitral/etiología , Insuficiencia de la Válvula Mitral/mortalidad , Insuficiencia de la Válvula Mitral/patología , Tamaño de los Órganos , Reoperación/estadística & datos numéricos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Resultado del TratamientoRESUMEN
BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a less invasive option for treatment of high-risk patients with severe aortic stenosis. We sought to identify patients at high risk for poor outcome after TAVR using a novel definition of outcome that integrates quality of life with mortality. METHODS AND RESULTS: Among 2137 patients who underwent TAVR in the PARTNER (Placement of Aortic Transcatheter Valve) trial or its associated continued access registry, quality of life was assessed with the Kansas City Cardiomyopathy Questionnaire-Overall Summary Scale (KCCQ-OS; range 0-100, where a higher score equates to a better quality of life) at baseline and at 1, 6, and 12 months after TAVR. A poor 6-month outcome (defined as death, KCCQ-OS score <45, or ≥10-point decrease in KCCQ-OS score compared with baseline) occurred in 704 patients (33%). Using a split-sample design, we developed a multivariable model to identify a parsimonious set of covariates to identify patients at high risk for poor outcome. The model demonstrated moderate discrimination (c-index=0.66) and good calibration with the observed data, performed similarly in the separate validation cohort (c-index=0.64), and identified 211 patients (10% of the population) with a ≥50% likelihood of a poor outcome after TAVR. A second model that explored predictors of poor outcome at 1 year identified 1102 patients (52%) with ≥50% likelihood and 178 (8%) with ≥70% likelihood of a poor 1-year outcome after TAVR. CONCLUSIONS: Using a large, multicenter cohort, we have developed and validated predictive models that can identify patients at high risk for a poor outcome after TAVR. Although model discrimination was moderate, these models may help guide treatment choices and offer patients realistic expectations of outcomes based on their presenting characteristics. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.
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Estenosis de la Válvula Aórtica/diagnóstico , Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas , Modelos Estadísticos , Anciano , Anciano de 80 o más Años , Estudios de Cohortes , Femenino , Estudios de Seguimiento , Humanos , Masculino , Análisis Multivariante , Pronóstico , Calidad de Vida , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Encuestas y Cuestionarios , Resultado del TratamientoRESUMEN
BACKGROUND: The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that among high-risk patients with aortic stenosis, the 1-year survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical replacement. However, longer-term follow-up is necessary to determine whether TAVR has prolonged benefits. METHODS: At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either surgical aortic-valve replacement or TAVR. All patients were followed for at least 2 years, with assessment of clinical outcomes and echocardiographic evaluation. RESULTS: The rates of death from any cause were similar in the TAVR and surgery groups (hazard ratio with TAVR, 0.90; 95% confidence interval [CI], 0.71 to 1.15; P=0.41) and at 2 years (Kaplan-Meier analysis) were 33.9% in the TAVR group and 35.0% in the surgery group (P=0.78). The frequency of all strokes during follow-up did not differ significantly between the two groups (hazard ratio, 1.22; 95% CI, 0.67 to 2.23; P=0.52). At 30 days, strokes were more frequent with TAVR than with surgical replacement (4.6% vs. 2.4%, P=0.12); subsequently, there were 8 additional strokes in the TAVR group and 12 in the surgery group. Improvement in valve areas was similar with TAVR and surgical replacement and was maintained for 2 years. Paravalvular regurgitation was more frequent after TAVR (P<0.001), and even mild paravalvular regurgitation was associated with increased late mortality (P<0.001). CONCLUSIONS: A 2-year follow-up of patients in the PARTNER trial supports TAVR as an alternative to surgery in high-risk patients. The two treatments were similar with respect to mortality, reduction in symptoms, and improved valve hemodynamics, but paravalvular regurgitation was more frequent after TAVR and was associated with increased late mortality. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.).
Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Cateterismo Cardíaco , Implantación de Prótesis de Válvulas Cardíacas/métodos , Anticoagulantes/efectos adversos , Anticoagulantes/uso terapéutico , Válvula Aórtica/diagnóstico por imagen , Insuficiencia de la Válvula Aórtica/clasificación , Insuficiencia de la Válvula Aórtica/etiología , Estenosis de la Válvula Aórtica/complicaciones , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/terapia , Cateterismo Cardíaco/efectos adversos , Femenino , Estudios de Seguimiento , Prótesis Valvulares Cardíacas , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Hemorragia/etiología , Heparina/efectos adversos , Heparina/uso terapéutico , Humanos , Estimación de Kaplan-Meier , Masculino , Inhibidores de Agregación Plaquetaria/efectos adversos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Complicaciones Posoperatorias , Falla de Prótesis , Accidente Cerebrovascular/etiología , Tasa de Supervivencia , Resultado del Tratamiento , UltrasonografíaRESUMEN
BACKGROUND: The effect of preoperative mitral regurgitation (MR) on clinical outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) is controversial. This study sought to examine the impact of moderate and severe MR on outcomes after TAVR and surgical aortic valve replacement (SAVR). METHODS AND RESULTS: Data were drawn from the randomized Placement of Aortic Transcatheter Valve (PARTNER) Trial cohort A patients with severe, symptomatic aortic stenosis undergoing either TAVR (n=331) or SAVR (n=299). Both TAVR and SAVR patients were dichotomized according to the degree of preoperative MR (moderate/severe versus none/mild). At baseline, moderate or severe MR was reported in 65 TAVR patients (19.6%) and 63 SAVR patients (21.2%). At 30 days, among survivors who had isolated SAVR/TAVR, moderate/severe MR had improved in 25 SAVR patients (69.4%) and 30 TAVR patients (57.7%), was unchanged in 10 SAVR patients (27.8%) and 19 TAVR patients (36.5%), and worsened in 1 SAVR patient (2.8%) and 4 TAVR patients (5.8%; all P=NS). Mortality at 2 years was higher in SAVR patients with moderate or severe MR than in those with mild or less MR (49.8% versus 28.1%; adjusted hazard ratio, 1.73; 95% confidence interval, 1.01-2.96; P=0.04). In contrast, MR severity at baseline did not affect mortality in TAVR patients (37.0% versus 32.7%, moderate/severe versus none/mild; hazard ratio, 1.14; 95% confidence interval, 0.72-1.78; P=0.58; P for interaction=0.05). CONCLUSIONS: Both TAVR and SAVR were associated with a significant early improvement in MR in survivors. However, moderate or severe MR at baseline was associated with increased 2-year mortality after SAVR but not after TAVR. TAVR may be a reasonable option in selected patients with combined aortic and mitral valve disease. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.
Asunto(s)
Estenosis de la Válvula Aórtica/terapia , Válvula Aórtica , Cateterismo Cardíaco/métodos , Procedimientos Quirúrgicos Cardíacos/métodos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Insuficiencia de la Válvula Mitral/complicaciones , Índice de Severidad de la Enfermedad , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/mortalidad , Estudios de Cohortes , Ecocardiografía , Femenino , Estudios de Seguimiento , Prótesis Valvulares Cardíacas , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Humanos , Estimación de Kaplan-Meier , Masculino , Tasa de Supervivencia , Resultado del TratamientoRESUMEN
BACKGROUND: Transcatheter mitral valve-in-valve replacement offers a less-invasive alternative for high-risk patients with bioprosthetic valve failure. Limited experience exists in intermediate-risk patients. We aim to evaluate 1-year outcomes of the PARTNER 3 mitral valve-in-valve study. METHODS: This prospective, single-arm, multicenter study enrolled symptomatic patients with a failing mitral bioprosthesis demonstrating greater than or equal to moderate stenosis and regurgitation and Society of Thoracic Surgeons score ≥3% and <8%. A balloon-expandable transcatheter heart valve (SAPIEN 3, Edwards Lifesciences) was used via a transeptal approach. The primary end point was the composite of all-cause mortality and stroke at 1 year. RESULTS: A total of 50 patients from 12 sites underwent mitral valve-in-valve from 2018 to 2021. The mean age was 70.1±9.7 years, mean Society of Thoracic Surgeons score was 4.1%±1.6%, and 54% were female. There were no primary end point events (mortality or stroke) through 1 year, and no left-ventricular outflow tract obstruction, endocarditis, or mitral valve reintervention was reported. Six patients (12%) required rehospitalization, including heart failure (n=2), minor procedural side effects (n=2), and valve thrombosis (n=2; both resolved with anticoagulation). An additional valve thrombosis was associated with no significant clinical sequelae. From baseline to 1 year, all subjects with available data had none/trace or mild (grade 1+) mitral regurgitation and the New York Heart Association class improved in 87.2% (41/47) of patients. CONCLUSIONS: Mitral valve-in-valve with a balloon-expandable valve via transseptal approach in intermediate-risk patients was associated with improved symptoms and quality of life, adequate transcatheter valve performance, and no mortality or stroke at 1-year follow-up. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03193801.
Asunto(s)
Bioprótesis , Cateterismo Cardíaco , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Insuficiencia de la Válvula Mitral , Válvula Mitral , Diseño de Prótesis , Falla de Prótesis , Recuperación de la Función , Humanos , Femenino , Masculino , Válvula Mitral/cirugía , Válvula Mitral/fisiopatología , Válvula Mitral/diagnóstico por imagen , Anciano , Estudios Prospectivos , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Factores de Tiempo , Resultado del Tratamiento , Factores de Riesgo , Persona de Mediana Edad , Cateterismo Cardíaco/instrumentación , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/mortalidad , Medición de Riesgo , Anciano de 80 o más Años , Insuficiencia de la Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/fisiopatología , Insuficiencia de la Válvula Mitral/mortalidad , Estados Unidos , Estenosis de la Válvula Mitral/cirugía , Estenosis de la Válvula Mitral/fisiopatología , Estenosis de la Válvula Mitral/mortalidad , Estenosis de la Válvula Mitral/diagnóstico por imagen , Hemodinámica , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/mortalidadRESUMEN
BACKGROUND: Frailty associates with worse outcomes after transcatheter aortic valve replacement (TAVR). Sarcopenia underlies frailty, but the association between a comprehensive assessment of sarcopenia-muscle mass, strength, and performance-and outcomes after TAVR has not been examined. METHODS: From a multicenter prospective registry of patients with symptomatic severe aortic stenosis undergoing TAVR, 445 who had a preprocedure computed tomography and clinical assessment of frailty were included. Cross-sectional muscle (psoas and paraspinal) areas were measured on computed tomography and indexed to height. Gait speed and handgrip strength were obtained, and patients were dichotomized into fast versus slow; strong versus weak; and normal versus low muscle mass. As measures of body composition, cross-sectional fat (subcutaneous and visceral) was measured and indexed to height. RESULTS: The frequency of patients who were slow, weak, and had low muscle mass was 56%, 59%, and 42%, respectively. Among the 3 components of sarcopenia, only slower gait speed (muscle performance) was independently associated with increased post-TAVR mortality (adjusted hazard ratio, 1.12 per 0.1 m/s decrease [95% CI, 1.04-1.21]; P=0.004; adjusted hazard ratio, 1.38 per 1 SD decrease [95% CI, 1.11-1.72]; P=0.004). Meeting multiple sarcopenia criteria was not associated with higher mortality risk than fewer. Lower indexed visceral fat area (adjusted hazard ratio, 1.48 per 1 SD decrease [95% CI, 1.15-1.89]; P=0.002) was associated with mortality but indexed subcutaneous fat was not. Death occurred in 169 (38%) patients. CONCLUSIONS: Among patients with symptomatic severe aortic stenosis and comprehensive sarcopenia and body composition phenotyping, gait speed was the only sarcopenia measure associated with post-TAVR mortality. Lower visceral fat was also associated with increased risk pointing to an obesity paradox also observed in other patient populations. These findings reinforce the clinical utility of gait speed as a measure of risk and a potential target for adjunctive interventions alongside TAVR to optimize clinical outcomes.
Asunto(s)
Estenosis de la Válvula Aórtica , Fragilidad , Sarcopenia , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Sarcopenia/diagnóstico por imagen , Sarcopenia/complicaciones , Fragilidad/diagnóstico , Fragilidad/complicaciones , Resultado del Tratamiento , Fuerza de la Mano , Estudios Transversales , Medición de Riesgo , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/complicaciones , Composición Corporal , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Factores de RiesgoRESUMEN
BACKGROUND: Pressure overload resulting from aortic stenosis causes maladaptive ventricular and vascular remodeling that can lead to pulmonary hypertension, heart failure symptoms, and adverse outcomes. Retarding or reversing this maladaptive remodeling and its unfavorable hemodynamic consequences has the potential to improve morbidity and mortality. Preclinical models of pressure overload have shown that phosphodiesterase type 5 inhibition is beneficial; however, the use of phosphodiesterase type 5 inhibitors in patients with aortic stenosis is controversial because of concerns about vasodilation and hypotension. METHODS AND RESULTS: We evaluated the safety and hemodynamic response of 20 subjects with severe symptomatic aortic stenosis (mean aortic valve area, 0.7 ± 0.2 cm(2); ejection fraction, 60 ± 14%) who received a single oral dose of sildenafil (40 or 80 mg). Compared with baseline, after 60 minutes, sildenafil reduced systemic (-12%; P<0.001) and pulmonary (-29%; P=0.002) vascular resistance, mean pulmonary artery (-25%; P<0.001) and wedge (-17%; P<0.001) pressures, and increased systemic (13%; P<0.001) and pulmonary (45%; P<0.001) vascular compliance and stroke volume index (8%; P=0.01). These changes were not dose dependent. Sildenafil caused a modest decrease in mean systemic arterial pressure (-11%; P<0.001) but was well tolerated with no episodes of symptomatic hypotension. CONCLUSIONS: This study shows for the first time that a single dose of a phosphodiesterase type 5 inhibitor is safe and well tolerated in patients with severe aortic stenosis and is associated with improvements in pulmonary and systemic hemodynamics resulting in biventricular unloading. These findings support the need for longer-term studies to evaluate the role of phosphodiesterase type 5 inhibition as adjunctive medical therapy in patients with aortic stenosis.
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Estenosis de la Válvula Aórtica/tratamiento farmacológico , Estenosis de la Válvula Aórtica/fisiopatología , Fosfodiesterasas de Nucleótidos Cíclicos Tipo 5/metabolismo , Inhibidores de Fosfodiesterasa 5/administración & dosificación , Piperazinas/administración & dosificación , Circulación Pulmonar/efectos de los fármacos , Sulfonas/administración & dosificación , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Presión Sanguínea/efectos de los fármacos , Adaptabilidad/efectos de los fármacos , Femenino , Humanos , Masculino , Inhibidores de Fosfodiesterasa 5/efectos adversos , Piperazinas/efectos adversos , Purinas/administración & dosificación , Purinas/efectos adversos , Índice de Severidad de la Enfermedad , Citrato de Sildenafil , Volumen Sistólico/efectos de los fármacos , Sulfonas/efectos adversos , Resultado del Tratamiento , Ultrasonografía , Resistencia Vascular/efectos de los fármacos , Función Ventricular Izquierda/efectos de los fármacos , Función Ventricular Derecha/efectos de los fármacosRESUMEN
OBJECTIVES: To assess the long-term clinical outcomes associated with treatment of nonleft main coronary bifurcation lesions using a modified provisional jailed-balloon technique (JBT). BACKGROUND: Percutaneous coronary intervention (PCI) of bifurcation lesions is associated with a higher risk of adverse events, including the risk of side branch (SB) loss during main branch (MB) stenting. METHODS: From 4/2003 to 8/2010, 406 patients with 424 nonleft main coronary bifurcation lesions underwent PCI with (n = 95) and without (n = 311) the use of JBT. Rates of SB loss and long term clinical outcomes [death, myocardial infarction (MI), and target lesion revascularization (TLR)] were compared between patients undergoing PCI with and without JBT using univariate and propensity score adjusted and matched analyses. RESULTS: The majority of patients presented with acute coronary syndrome (63%) and 90% of lesions were Medina class 1,1,1. Patients were followed for a mean of 2.7 ± 2.1 years. After propensity score matching (n = 81 in each group), JBT was associated with a significantly lower composite rate of death, MI, or TLR (HR 0.22, 95% CI 0.06-0.76; P = 0.02) and TLR (HR 0.20, 95% 0.04-0.92; P = 0.04) compared with no JBT. Permanent SB loss was significantly lower in the JBT group compared with no JBT group (OR 0.22, 95% CI 0.10-0.49; P = 0.0001). CONCLUSIONS: The use of JBT for the treatment of nonleft main coronary bifurcation lesions was associated with significantly lower rates of SB loss and major adverse cardiac events at late follow-up.
Asunto(s)
Síndrome Coronario Agudo/terapia , Angioplastia Coronaria con Balón/métodos , Enfermedad de la Arteria Coronaria/terapia , Síndrome Coronario Agudo/diagnóstico , Síndrome Coronario Agudo/mortalidad , Anciano , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/mortalidad , Distribución de Chi-Cuadrado , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/mortalidad , Reestenosis Coronaria/etiología , Reestenosis Coronaria/prevención & control , Femenino , Humanos , Estimación de Kaplan-Meier , Modelos Logísticos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/etiología , Infarto del Miocardio/prevención & control , Oportunidad Relativa , Puntaje de Propensión , Modelos de Riesgos Proporcionales , Estudios Retrospectivos , Factores de Riesgo , Stents , Factores de Tiempo , Resultado del TratamientoRESUMEN
A 38-year-old with Turner syndrome presented with acute myocardial infarction due to multivessel spontaneous coronary artery dissection (SCAD) complicated by left ventricular free wall rupture. Conservative management for SCAD was pursued. She underwent sutureless repair for an oozing-type left ventricular free wall rupture. SCAD has not been previously reported in Turner syndrome. (Level of Difficulty: Advanced.).
RESUMEN
A 31-year-old woman with a mechanical aortic valve for congenital aortic stenosis presented to the cardiology clinic for preconception counseling. After experiencing an acute stroke 4 weeks prior, she was subsequently discovered to have prosthetic valve thrombosis requiring replacement of the aortic valve. We discuss her clinical course and preconception considerations.
RESUMEN
Nontraumatic exertional syncope can be an ominous event reflecting profound arterial hypotension, cerebral hypoperfusion, and transient loss-of consciousness that occurs most commonly in patients with underlying cardiovascular disease. In contradistinction, transient loss-of-consciousness in "healthy adults" is typically vasovagal syncope related to exaggerated orthostatic cardiovascular responses attributed to a hyper-reactive autonomic nervous system. In the present report, a 34 yo male presents to the hospital emergency department (ED) for a sudden loss of consciousness and fall ultimately related to cardiac syncope ascribed to chronic recreational marijuana use complicated by coronary vasospasm.