RESUMEN
OBJECTIVES: The aim of this study is to describe the initial experience with versacross transseptal (TS) system for transseptal puncture for the transcatheter mitral valve repair using the MitraClip device. BACKGROUND: Transeptal puncture is a key step in transcatheter mitral valve repair (MVR) and the use of the VersaCross system comprised of a sheath, a dilator and a radiofrequency wire has not been previously described. METHODS: Prospective single center study of consecutive patients undergoing transcatheter mitral valve repair with the MitraClip device were included. Targeted TS puncture was performed under transesophageal echocardiographic (TEE) guidance. Baseline demographics, procedural characteristics, and major adverse procedural events were collected. RESULTS: Twenty-five consecutive patients underwent transseptal puncture using the VersaCross TS system. Transseptal puncture was successful in 100% of patients. The mean time for TS puncture was 3 3 ± 1.6 min with no major adverse procedural events. The mean time from insertion of the VersaCross system to insertion of the MitraClip guide catheter was 3.8 ± 3.0 minutes. CONCLUSION: The VersaCross TS system was successful in all patients for MitraClip procedure with no adverse procedural events and may be associated with increased procedural efficiency.
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Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Cateterismo Cardíaco/efectos adversos , Ecocardiografía Transesofágica , Humanos , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/cirugía , Estudios Prospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: The COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) demonstrated that edge-to-edge transcatheter mitral valve repair (TMVr) with the MitraClip resulted in reduced mortality and heart failure hospitalizations and improved quality of life compared with maximally tolerated guideline-directed medical therapy (GDMT) in patients with heart failure and 3 to 4+ secondary mitral regurgitation. Whether TMVr is cost-effective compared with GDMT in this population is unknown. METHODS: We used data from the COAPT trial to perform a formal patient-level economic analysis of TMVr+GDMT versus GDMT alone for patients with heart failure and 3 to 4+ secondary mitral regurgitation from the perspective of the US healthcare system. Costs for the index TMVr hospitalization were assessed using a combination of resource-based accounting and hospital billing data (when available). Follow-up medical care costs were estimated on the basis of medical resource use collected during the COAPT trial. Health utilities were estimated for all patients at baseline and 1, 6, 12, and 24 months with the Short Form Six-Dimension Health Survey. RESULTS: Initial costs for the TMVr procedure and index hospitalization were $35 755 and $48 198, respectively. Although follow-up costs were significantly lower with TMVr compared with GDMT ($26 654 versus $38 345; P=0.018), cumulative 2-year costs remained higher with TMVr because of the upfront cost of the index procedure ($73 416 versus $38 345; P<0.001). When in-trial survival, health utilities, and costs were modeled over a lifetime horizon, TMVr was projected to increase life expectancy by 1.13 years and quality-adjusted life-years by 0.82 years at a cost of $45 648, yielding a lifetime incremental cost-effectiveness ratio of $40 361 per life-year gained and $55 600 per quality-adjusted life-year gained. CONCLUSIONS: For symptomatic patients with heart failure and 3 to 4+ secondary mitral regurgitation, TMVr increases life expectancy and quality-adjusted life expectancy compared with GDMT at an incremental cost per quality-adjusted life-year gained that represents acceptable economic value according to current US thresholds. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01626079.
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Cateterismo Cardíaco/economía , Procedimientos Endovasculares/economía , Insuficiencia Cardíaca/cirugía , Insuficiencia de la Válvula Mitral/cirugía , Válvula Mitral/cirugía , Anciano , Anciano de 80 o más Años , Cateterismo Cardíaco/métodos , Comorbilidad , Análisis Costo-Beneficio , Procedimientos Endovasculares/instrumentación , Procedimientos Endovasculares/métodos , Femenino , Estudios de Seguimiento , Insuficiencia Cardíaca/tratamiento farmacológico , Insuficiencia Cardíaca/economía , Hospitalización/economía , Humanos , Masculino , Persona de Mediana Edad , Insuficiencia de la Válvula Mitral/tratamiento farmacológico , Insuficiencia de la Válvula Mitral/economía , Estudios Multicéntricos como Asunto/estadística & datos numéricos , Prótesis e Implantes/economía , Calidad de Vida , Años de Vida Ajustados por Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto/estadística & datos numéricos , Volumen Sistólico , Insuficiencia de la Válvula Tricúspide/complicaciones , Estados UnidosRESUMEN
BACKGROUND: Older adults undergoing aortic valve replacement (AVR) are at risk for malnutrition. The association between preprocedural nutritional status and midterm mortality has yet to be determined. METHODS: The FRAILTY-AVR (Frailty in Aortic Valve Replacement) prospective multicenter cohort study was conducted between 2012 and 2017 in 14 centers in 3 countries. Patients ≥70 years of age who underwent transcatheter or surgical AVR were eligible. The Mini Nutritional Assessment-Short Form was assessed by trained observers preprocedure, with scores ≤7 of 14 considered malnourished and 8 to 11 of 14 considered at risk for malnutrition. The Short Performance Physical Battery was simultaneously assessed to measure physical frailty, with scores ≤5 of 12 considered severely frail and 6 to 8 of 12 considered mildly frail. The primary outcome was 1-year all-cause mortality, and the secondary outcome was 30-day composite mortality or major morbidity. Multivariable regression models were used to adjust for potential confounders. RESULTS: There were 1158 patients (727 transcatheter AVR and 431 surgical AVR), with 41.5% females, a mean age of 81.3 years, a mean body mass index of 27.5 kg/m2, and a mean Society of Thoracic Surgeons-Predicted Risk of Mortality of 5.1%. Overall, 8.7% of patients were classified as malnourished and 32.8% were at risk for malnutrition. Mini Nutritional Assessment-Short Form scores were modestly correlated with Short Performance Physical Battery scores (Spearman R=0.31, P<0.001). There were 126 deaths in the transcatheter AVR group (19.1 per 100 patient-years) and 30 deaths in the surgical AVR group (7.5 per 100 patient-years). Malnourished patients had a nearly 3-fold higher crude risk of 1-year mortality compared with those with normal nutritional status (28% versus 10%, P<0.001). After adjustment for frailty, Society of Thoracic Surgeons-Predicted Risk of Mortality, and procedure type, preprocedural nutritional status was a significant predictor of 1-year mortality (odds ratio, 1.08 per Mini Nutritional Assessment-Short Form point; 95% CI, 1.01-1.16) and of the 30-day composite safety end point (odds ratio, 1.06 per Mini Nutritional Assessment-Short Form point; 95% CI, 1.001-1.12). CONCLUSIONS: Preprocedural nutritional status is associated with mortality in older adults undergoing AVR. Clinical trials are needed to determine whether pre- and postprocedural nutritional interventions can improve clinical outcomes in these vulnerable patients.
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Estenosis de la Válvula Aórtica/patología , Desnutrición/patología , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/complicaciones , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/cirugía , Índice de Masa Corporal , Estudios de Cohortes , Femenino , Anciano Frágil , Humanos , Estimación de Kaplan-Meier , Modelos Logísticos , Masculino , Desnutrición/complicaciones , Estado Nutricional , Oportunidad Relativa , Estudios Prospectivos , Factores de Riesgo , Índice de Severidad de la EnfermedadRESUMEN
BACKGROUND/OBJECTIVE: Prostar XL (PS) and ProGlide (PG) are common vascular closure devices (VCD) used in TAVR via transfemoral vascular approach. The impact of these VCD on vascular and bleeding complications remains unclear. METHODS: The BRAVO-3 trial randomized 802 patients undergoing transfemoral TAVR. We stratified patients according to type of VCD used and examined the 30-day incidence of major or minor vascular complications, major bleeding (BARC ≥3b), AKI and major adverse cardiac and cerebrovascular events (MACCE; death, myocardial infarction or stroke). RESULTS: A total of 746 (93%) patients were treated with either PS (n = 352, 47%) or PG (n = 394, 53%) VCD, without significant differences in successful deployment rate (PS 322 [91.2%] vs. PG 373 [94.2%] respectively, p = .20). PG was associated with a significantly lower incidence of major or minor vascular complications, compared to PS (adjusted OR: 0.54; 95% CI: 0.37-0.80; p < .01). Rates of acute kidney injury were also lower with the PG device. There was no significant difference between bleeding, MACCE, and death. CONCLUSIONS: Compared to PS, the PG VCD was associated with a lower rate of major or minor vascular complications and lower rates of AKI after transfemoral TAVR.
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Estenosis de la Válvula Aórtica/cirugía , Hemorragia/prevención & control , Técnicas Hemostáticas/instrumentación , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Dispositivos de Cierre Vascular , Enfermedades Vasculares/prevención & control , Lesión Renal Aguda/etiología , Lesión Renal Aguda/prevención & control , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/mortalidad , Canadá , Diseño de Equipo , Europa (Continente) , Femenino , Hemorragia/etiología , Hemorragia/mortalidad , Técnicas Hemostáticas/efectos adversos , Técnicas Hemostáticas/mortalidad , Humanos , Masculino , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de Riesgo , Factores de Tiempo , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Resultado del Tratamiento , Enfermedades Vasculares/etiología , Enfermedades Vasculares/mortalidadRESUMEN
BACKGROUND: Bioresorbable vascular scaffolds (BVS) implantation in selected patients with stable angina has been demonstrated feasible and safe. However, limited data are currently available on long-term outcomes after BVS implantation for ST-elevation myocardial infarction (STEMI). Therefore, we sought to assess the safety, efficacy and long-term results of BVS implantation in STEMI patients. METHODS: Retrospective review of all STEMI patients treated with the Absorb® BVS (Abbott Vascular, Santa Clara, CA) or conventional drug eluting stent (DES) between 1 April 2013 and 30 March 2014. Primary outcomes were procedural success, device thrombosis and device-oriented composite endpoint (DOCE) including cardiac death, target vessel myocardial infarction and target lesion revascularization. The study included 54 BVS patients and 121 DES patients. RESULTS: Patients were slightly younger in the BVS group (60 vs. 63 years old, p = .03). Other baseline characteristics were comparable between the two groups. Procedural success was achieved in all patients. Median follow-up was 901 days and 849 days for BVS and DES patients, respectively (p = .01). The cumulative incidence of DOCE was not significantly different between the BVS and DES groups (7.5% vs. 9.1%, hazard ratio [HR]: 0.74 [95% confidence interval (CI): 0.26-2.2], p = NS). Rate of probable/definite device thrombosis were not statistically different between both groups (3.7% vs. 3.3%, p = NS). CONCLUSIONS: The results of this single-centre retrospective study, one of the first assessing long-term safety and efficacy of BVS in STEMI, seems reassuring with similar long-term results as compared with patients treated with conventional DES.
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Implantes Absorbibles , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea/métodos , Infarto del Miocardio con Elevación del ST/cirugía , Andamios del Tejido , Anciano , Angiografía Coronaria , Electrocardiografía , Femenino , Estudios de Seguimiento , Oclusión de Injerto Vascular/epidemiología , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Diseño de Prótesis , Quebec/epidemiología , Estudios Retrospectivos , Infarto del Miocardio con Elevación del ST/diagnóstico , Factores de Tiempo , Resultado del TratamientoRESUMEN
Edge to edge transcatheter mitral valve repair with MitraClip (Abbott Vascular, Menlo Park, CA) is increasing for high-risk surgical patients with significant mitral regurgitation. Patients with congenitally corrected transposition of the great arteries (CCTGA) presenting with tricuspid valve regurgitation of a systemic right ventricle may represent particularly challenging candidates for MitraClip given their anatomy. We report the case of a 67-year-old gentleman with CCTGA and severe tricuspid regurgitation who was referred for MitraClip implantation after heart team consensus. Successful implantation of one clip was performed, achieving a significant reduction of the regurgitation. Similarly, favorable findings were confirmed at 6 months, 1 and 2 years follow-up and the patient had no recurrent heart failure admissions after 2-year follow-up. We describe the technical considerations and the importance of 3D-transoesophageal echocardiography for performing the MitraClip of a trileaflet systemic atrioventricular valve. © 2016 Wiley Periodicals, Inc.
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Cateterismo Cardíaco/instrumentación , Transposición de los Grandes Vasos/complicaciones , Insuficiencia de la Válvula Tricúspide/terapia , Válvula Tricúspide/fisiopatología , Anciano , Transposición Congénitamente Corregida de las Grandes Arterias , Ecocardiografía Doppler en Color , Ecocardiografía Tridimensional , Ecocardiografía Transesofágica , Humanos , Masculino , Recuperación de la Función , Índice de Severidad de la Enfermedad , Factores de Tiempo , Transposición de los Grandes Vasos/diagnóstico , Resultado del Tratamiento , Válvula Tricúspide/diagnóstico por imagen , Insuficiencia de la Válvula Tricúspide/diagnóstico por imagen , Insuficiencia de la Válvula Tricúspide/fisiopatología , Función Ventricular DerechaRESUMEN
OBJECTIVES: To report the initial clinical experience with a novel atrial septal defect (ASD) closure device, the GORE® CARDIOFORM ASD Occluder (GCO). BACKGROUND: Transcatheter closure has become the treatment of choice for secundum ASD. A wide range of occluder devices are available, but concern has been raised about the risk of cardiac erosion associated with rigid devices and future access to the left atrium METHODS: Retrospective chart review of patients treated with the GCO at three Canadian centers. Primary outcomes were procedural success and residual shunting at follow-up, as well as 30-day major adverse events. Secondary outcomes included new onset atrial arrhythmias, wire frame fractures (WFF), and all cause mortality. Clinical, echocardiographic, procedural data, and follow-up outcome variables were collected in each participating hospital. RESULTS: Between February and December 2015, 26 patients (5 children and 21 adults) underwent transcatheter ASD closure with the GCO and were included in the study cohort. Procedural success was achieved in 22 of 26 patients (85%) and no major procedural complications were observed. Two patients (8%) presented new onset atrial tachyarrhythmia during early follow-up (0-30 days). Follow-up echocardiography (median of 119 days [IQR: 92-146]) demonstrated no residual shunt in all implanted patients. After a median clinical follow-up of 174 days (IQR: 135-239), one patient died of an unrelated cause, there were no documented major adverse cardiovascular events. Fluoroscopic imaging of the device was performed in 20 patients (91%), and WFF was noted in five cases. No clinical consequence or device dysfunction was observed in these patients. CONCLUSIONS: In this first-in-man multicenter study, the GCO was safe and effective for ASD closure, with no major adverse events or residual shunt at follow-up. © 2017 Wiley Periodicals, Inc.
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Cateterismo Cardíaco/instrumentación , Defectos del Tabique Interatrial/terapia , Dispositivo Oclusor Septal , Adolescente , Adulto , Aleaciones , Arritmias Cardíacas/etiología , Cateterismo Cardíaco/efectos adversos , Niño , Preescolar , Ecocardiografía Doppler en Color , Ecocardiografía Transesofágica , Femenino , Defectos del Tabique Interatrial/diagnóstico por imagen , Defectos del Tabique Interatrial/fisiopatología , Humanos , Masculino , Persona de Mediana Edad , Ontario , Politetrafluoroetileno , Diseño de Prótesis , Quebec , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Vascular complications (VC) are a serious and frequent complication of transfemoral transcatheter aortic valve implantation (TAVI) and result in increased morbidity and mortality. It has been suggested that newly developed vascular sheaths may increase the ability to perform transfemoral TAVI in patients with normal and access-limiting peripheral artery disease (PAD) and reduce vascular complications. AIMS: We sought to assess the safety and efficacy of the 19 French (F) SoloPath balloon-expandable transfemoral vascular access system in patients who underwent transfemoral TAVI at our center between 2011 and 2014. METHODS AND RESULTS: Single-center retrospective study of 90 patients who underwent transfemoral TAVI with the use of the SoloPath sheath. Patients were categorized into two groups according to a sheath to femoral artery ratio (SFAR) of less than or equal to 1.05, or greater than 1.05. Overall, the incidence of major bleeding complications was low, 4.4%. No significant differences were found in technical or procedural success rates (100% in both groups and 100% vs. 91.3; P = 0.09; respectively), total vascular complications (20.8 vs. 21.7; P = 0.92) or total bleeding complications (20.8 vs. 30.4; P = 0.36 between those with SFAR greater or less than 1.05. CONCLUSIONS: The use of the SoloPath balloon-expandable sheath is feasible and safe even in patients with SFAR > 1.05, showing no increased vascular or bleeding complications compared to patients with larger vascular access. © 2016 Wiley Periodicals, Inc.
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Angioplastia de Balón/instrumentación , Válvula Aórtica , Cateterismo Cardíaco , Cateterismo Periférico/instrumentación , Arteria Femoral , Enfermedades de las Válvulas Cardíacas/terapia , Implantación de Prótesis de Válvulas Cardíacas , Enfermedad Arterial Periférica/terapia , Dispositivos de Acceso Vascular , Anciano , Anciano de 80 o más Años , Angioplastia de Balón/efectos adversos , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/métodos , Cateterismo Periférico/efectos adversos , Cateterismo Periférico/métodos , Diseño de Equipo , Estudios de Factibilidad , Femenino , Arteria Femoral/diagnóstico por imagen , Arteria Femoral/lesiones , Arteria Femoral/fisiopatología , Enfermedades de las Válvulas Cardíacas/complicaciones , Enfermedades de las Válvulas Cardíacas/diagnóstico por imagen , Enfermedades de las Válvulas Cardíacas/fisiopatología , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Hemorragia/etiología , Humanos , Masculino , Enfermedad Arterial Periférica/complicaciones , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/fisiopatología , Punciones , Quebec , Estudios Retrospectivos , Factores de Riesgo , Resultado del Tratamiento , Lesiones del Sistema Vascular/etiologíaRESUMEN
OBJECTIVES: To evaluate the impact of baseline left ventricular (LV) function on the clinical outcomes of patients with functional mitral regurgitation (FMR) treated with MitraClip. BACKGROUND: It is unknown whether patients with significant FMR and severe LV dysfunction benefit from MitraClip. METHODS: A cohort of 77 patients with significant FMR undergoing MitraClip procedure between December 2010 and January 2015 was categorized by baseline LV ejection fraction (LVEF) into tertiles: LVEF <27% (n = 27), LVEF 27-37% (n = 25), and LVEF >37% (n = 25). We sought to evaluate the impact of LVEF on all-cause mortality at follow-up. RESULTS: There were no significant differences in baseline comorbidities, medical treatment and MR severity among tertiles of LVEF. Overall procedural success was 94%, with no differences among groups (LVEF <27%: 89%; LVEF 27-37%: 100%; LVEF >37%: 92%; P = 0.25). Median follow-up was 372 days (interquartile range: 128-627 days). MR severity improved in all three groups, as compared to baseline. There were no differences in the prevalence of MR ≤2+ on follow-up (P = 0.40). Mortality was highest in patients with LVEF <27% (41%), as compared with LVEF 27-37% (16%) and LVEF >37% (4%), P = 0.004. Patient who died had a lower baseline LVEF compared to those who survived (24.8 ± 7.7% versus 35.5 ± 13.7%, P < 0.001). An LVEF <27% was an independent predictor of mortality after adjusting for procedural success: hazard ratio 3.4 (95% CI: 1.1 to 10.0; P = 0.030). CONCLUSIONS: MitraClip is effective in FMR patients regardless of the severity of LV dysfunction. However, low baseline LVEF is associated with increased mortality, despite procedural success. © 2016 Wiley Periodicals, Inc.
Asunto(s)
Cateterismo Cardíaco , Insuficiencia de la Válvula Mitral/terapia , Válvula Mitral/fisiopatología , Disfunción Ventricular Izquierda/fisiopatología , Función Ventricular Izquierda , Anciano , Anciano de 80 o más Años , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/instrumentación , Cateterismo Cardíaco/mortalidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/complicaciones , Insuficiencia de la Válvula Mitral/mortalidad , Insuficiencia de la Válvula Mitral/fisiopatología , Recuperación de la Función , Estudios Retrospectivos , Factores de Riesgo , Índice de Severidad de la Enfermedad , Volumen Sistólico , Factores de Tiempo , Resultado del Tratamiento , Disfunción Ventricular Izquierda/complicaciones , Disfunción Ventricular Izquierda/diagnóstico por imagen , Disfunción Ventricular Izquierda/mortalidadRESUMEN
OBJECTIVES: The objective of the present study was to assess if the presence and severity of CAD is associated with decreased LVEF recovery after TAVI. BACKGROUND: Coronary artery disease (CAD) and low left ventricular ejection fraction (LVEF) are common findings in patients undergoing transcatheter aortic valve implantation (TAVI). The impact of CAD on LVEF recovery after TAVI has not been specifically evaluated. METHODS: All patients with LVEF≤50% who underwent TAVI between March 2006 and May 2012 were included in the study. The presence and severity of coronary artery disease was measured using the Duke Myocardial Jeopardy Score (DMJS). A DMJS = 0 corresponds to patients without CAD or complete revascularization and a DMJS > 0 to those with incomplete revascularization. LVEF recovery was assessed by transthoracic echocardiography, measuring the change in LVEF from baseline to 3-months post-TAVI. Myocardial viability was evaluated in a subgroup of patients using cardiac magnetic resonance (CMR) imaging pre-TAVI. RESULTS: Fifty-six patients were included in the study. Twenty-eight patients (50%) had a DMJS > 0. At 3 months, patients with incomplete revascularization (DMJS > 0) demonstrated less LVEF recovery post-TAVI (2.0 ± 9.2% versus 11.7 ± 8.9% if DMJS = 0; P = 0.001). On multivariate analysis, DMJS and presence of significant delayed-enhancement were found to be independent predictors of LVEF recovery. Patients with incomplete revascularization exhibited a worse prognosis with higher mortality at 30-days (22.2% versus 0% if DMJS = 0; P = 0.010) and 1-year (25.9% versus 3.5% if DMJS = 0; P = 0.019). CONCLUSIONS: The present study demonstrates an independent association between incomplete revascularization and decreased LVEF recovery in patients with left ventricular dysfunction undergoing TAVI for severe aortic stenosis.
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Estenosis de la Válvula Aórtica/terapia , Cateterismo Cardíaco/métodos , Enfermedad de la Arteria Coronaria/terapia , Implantación de Prótesis de Válvulas Cardíacas/métodos , Intervención Coronaria Percutánea , Volumen Sistólico , Función Ventricular Izquierda , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/complicaciones , Estenosis de la Válvula Aórtica/diagnóstico , Estenosis de la Válvula Aórtica/fisiopatología , Cateterismo Cardíaco/efectos adversos , Distribución de Chi-Cuadrado , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/complicaciones , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/fisiopatología , Ecocardiografía , Femenino , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Humanos , Modelos Lineales , Imagen por Resonancia Magnética , Masculino , Análisis Multivariante , Intervención Coronaria Percutánea/efectos adversos , Valor Predictivo de las Pruebas , Recuperación de la Función , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del TratamientoAsunto(s)
Cateterismo Cardíaco , Cardiólogos/educación , Cardiología/educación , Educación de Postgrado en Medicina , Cardiopatías Congénitas/terapia , Internado y Residencia , Radiología Intervencionista/educación , Sobrevivientes , Competencia Clínica , Consenso , Continuidad de la Atención al Paciente , Curriculum , Cardiopatías Congénitas/diagnóstico , Cardiopatías Congénitas/fisiopatología , HumanosRESUMEN
Mitral regurgitation (MR) is one of the most prevalent types of valvular heart disease and is expected to increase in the next decade. Transcatheter therapies for MR are constantly being developed and studied for use in this population. In this review, the author describes the phenotypes of functional or secondary mitral regurgitation, discusses the potential therapeutic targets for transcatheter intervention, and reviews the results of such technology in the literature.
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Enfermedades de las Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Humanos , Insuficiencia de la Válvula Mitral/cirugía , TecnologíaRESUMEN
We present a case of a patient known for dextrotransposition of the great arteries corrected with a Mustard procedure, in whom severe mitral valve regurgitation secondary to transvenous lead extraction was successfully repaired with transcatheter edge-to-edge repair using the TriClip device (Abbott Vascular).
RESUMEN
OBJECTIVES: The SavvyWire(OpSens Medical) is a support wire for transcatheter aortic valve replacement (TAVR) procedures that, in addition to its dedicated left ventricle (LV) pacing capabilities, has a distal pressure sensor that measures live transvalvular hemodynamics during the procedure. We aimed to determine the safety, efficacy, and functionality of the SavvyWire during TAVR procedures in an all-comer population. METHODS: We performed a multicentric, prospective, observational, single-arm, all-comers registry of patients with symptomatic, severe aortic stenosis undergoing TAVR in 3 Canadian centers. Data were collected in a dedicated database, and pre-specified questionnaires were fulfilled by the heart team implanters after each procedure. RESULTS: A total of 60 patients were included (mean age: 78.6 ± 7.2 years; 51% women; mean Society of Thoracic Surgeons score: 2.2 ± 1.6%). TAVR was performed through a transfemoral approach in 90% of cases, and balloon- and self-expandable valves were used in 73% and 27% of patients, respectively. There were no cases of LV perforation, guidewire deformation, significant loss of capture, or major software malfunction. The rate of successful delivery of the TAVR system was 100%, and effective LV pacing was achieved in 98% of patients. The pre-TAVR mean gradient was 39 ± 14 mm Hg while the final post-TAVR gradient was 8 ± 5 mm Hg; the mean aortic systolic pressure during rapid pacing was 54 ± 12 mm Hg. In 97% of the TAVR procedures, SavvyWire's functionality was reported to be better or similar to other TAVR workhorse support wires. CONCLUSIONS: SavvyWire was safe, effective, and functional for live transvalvular hemodynamic evaluation and rapid pacing during TAVR procedures. More studies with larger sample sizes and comparison against different wires and gradient measurement methods are warranted.
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Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico , Estenosis de la Válvula Aórtica/cirugía , Canadá , Hemodinámica , Estudios Prospectivos , Diseño de Prótesis , Factores de Riesgo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Resultado del TratamientoRESUMEN
Cardiovascular conditions are among the most frequent causes of impairment to drive, because they might induce unpredictable mental state alterations via diverse mechanisms like myocardial ischemia, cardiac arrhythmias, and vascular dysfunction. Accordingly, health professionals are often asked to assess patients' fitness to drive (FTD). The Canadian Cardiovascular Society previously published FTD guidelines in 2003-2004; herein, we present updated FTD guidelines. Because there are no randomized trials on FTD, observational studies were used to estimate the risk of driving impairment in each situation, and recommendations made on the basis of Canadian Cardiovascular Society Risk of Harm formula. More restrictive recommendations were made for commercial drivers, who spend longer average times behind the wheel, use larger vehicles, and might transport a larger number of passengers. We provide guidance for individuals with: (1) active coronary artery disease; (2) various forms of valvular heart disease; (3) heart failure, heart transplant, and left ventricular assist device situations; (4) arrhythmia syndromes; (5) implantable devices; (6) syncope history; and (7) congenital heart disease. We suggest appropriate waiting times after cardiac interventions or acute illnesses before driving resumption. When short-term driving cessation is recommended, recommendations are on the basis of expert consensus rather than the Risk of Harm formula because risk elevation is expected to be transient. These recommendations, although not a substitute for clinical judgement or governmental regulations, provide specialists, primary care providers, and allied health professionals with a comprehensive list of a wide range of cardiac conditions, with guidance provided on the basis of the level of risk of impairment, along with recommendations about ability to drive and the suggested duration of restrictions.
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Sistema Cardiovascular , Enfermedad de la Arteria Coronaria , Demencia Frontotemporal , Isquemia Miocárdica , Humanos , Canadá/epidemiología , Arritmias Cardíacas/terapiaRESUMEN
Transcatheter closure of an atrial septal defect (ASD) is considered the standard of care for most of the patients with secundum ASD. The existence of multiple or fenestrated ASD may constitute a challenge to achieve a satisfactory result. Data on the usage of multiple devices for closing multiple defects are limited. The GORE Septal Occluder (GSO) represents a new generation of transcatheter ASD occluders with a design that provides superior conformability, apposition, and closure performance compared with the previous GORE HELEX device. The present case report describes the first clinical experience with the implantation of two GSO devices in a patient with multiple ASDs and fenestrated septum.
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Cateterismo Cardíaco/instrumentación , Defectos del Tabique Interatrial/terapia , Dispositivo Oclusor Septal , Anciano , Ecocardiografía Tridimensional , Ecocardiografía Transesofágica , Fluoroscopía , Defectos del Tabique Interatrial/diagnóstico , Humanos , Masculino , Diseño de Prótesis , Resultado del TratamientoRESUMEN
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.
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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 adversosRESUMEN
BACKGROUND: Anatomical and clinical criteria to define mitral transcatheter edge-to-edge repair (TEER) "unsuitability" have been proposed on the basis of a Heart Valve Collaboratory consensus opinion from physician experience with early-generation TEER devices but lacked an evidence-based approach. OBJECTIVES: The aim of this study was to explore the spectrum of TEER suitability using echocardiographic and clinical outcomes from the EXPAND G4 real-world postapproval study. METHODS: EXPAND G4 is a global, prospective, multicenter, single-arm study that enrolled 1,164 subjects with mitral regurgitation (MR) treated with the MitraClip G4 System. Three groups were defined using the Heart Valve Collaboratory TEER unsuitability criteria: 1) risk of stenosis (RoS); 2) risk of inadequate MR reduction (RoIR); and 3) subjects with baseline moderate or less MR (MMR). A TEER-suitable (TS) group was defined by the absence of these characteristics. Endpoints included independent core laboratory-assessed echocardiographic characteristics, procedural outcomes, MR reduction, NYHA functional class, Kansas City Cardiomyopathy Questionnaire score, and major adverse events through 30 days. RESULTS: Subjects in the RoS (n = 56), RoIR (n = 54), MMR (n = 326), and TS (n = 303) groups had high 30-day MR reduction rates (≤1+: RoS 97%, MMR 93%, and TS 91%; ≤2+: RoIR 94%). Thirty-day improvements in functional capacity (NYHA functional class I or II at 30 days vs baseline: RoS 94% vs 29%, RoIR 88% vs 30%, MMR 79% vs 26%, and TS 83% vs 33%) and quality of life (change in Kansas City Cardiomyopathy Questionnaire score: RoS +27 ± 26, RoIR +16 ± 26, MMR +19 ± 26, and TS +19 ± 24) were safely achieved in all groups, with low major adverse events (<3%) and all-cause mortality (RoS 1.8%, RoIR 0%, MMR 1.5%, and TS 1.3%). CONCLUSIONS: Patients previously deemed TEER unsuitable can be safely and effectively treated with the mitral TEER fourth-generation device.
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Cardiomiopatías , Insuficiencia de la Válvula Mitral , Humanos , Estudios Prospectivos , Calidad de Vida , Especies Reactivas de Oxígeno , Resultado del Tratamiento , Constricción Patológica , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/cirugíaRESUMEN
BACKGROUND: Although >150,000 mitral TEER procedures have been performed worldwide, the impact of MR etiology on MV surgery after TEER remains unknown. OBJECTIVES: The authors sought to compare outcomes of mitral valve (MV) surgery after failed transcatheter edge-to-edge repair (TEER) stratified by mitral regurgitation (MR) etiology. METHODS: Data from the CUTTING-EDGE registry were retrospectively analyzed. Surgeries were stratified by MR etiology: primary (PMR) and secondary (SMR). MVARC (Mitral Valve Academic Research Consortium) outcomes at 30 days and 1 year were evaluated. Median follow-up was 9.1 months (IQR: 1.1-25.8 months) after surgery. RESULTS: From July 2009 to July 2020, 330 patients underwent MV surgery after TEER, of which 47% had PMR and 53.0% had SMR. Mean age was 73.8 ± 10.1 years, median STS risk at initial TEER was 4.0% (IQR: 2.2%-7.3%). Compared with PMR, SMR had a higher EuroSCORE, more comorbidities, lower LVEF pre-TEER and presurgery (all P < 0.05). SMR patients had more aborted TEER (25.7% vs 16.3%; P = 0.043), more surgery for mitral stenosis after TEER (19.4% vs 9.0%; P = 0.008), and fewer MV repairs (4.0% vs 11.0%; P = 0.019). Thirty-day mortality was numerically higher in SMR (20.4% vs 12.7%; P = 0.072), with an observed-to-expected ratio of 3.6 (95% CI: 1.9-5.3) overall, 2.6 (95% CI: 1.2-4.0) in PMR, and 4.6 (95% CI: 2.6-6.6) in SMR. SMR had significantly higher 1-year mortality (38.3% vs 23.2%; P = 0.019). On Kaplan-Meier analysis, the actuarial estimates of cumulative survival were significantly lower in SMR at 1 and 3 years. CONCLUSIONS: The risk of MV surgery after TEER is nontrivial, with higher mortality after surgery, especially in SMR patients. These findings provide valuable data for further research to improve these outcomes.