RESUMEN
OBJECTIVES: This study sought to evaluate the 30-day and 1-year safety and performance of the Hydra transcatheter aortic valve (THV) (in the treatment of symptomatic severe aortic stenosis in patients at high or extreme surgical risk. BACKGROUND: The Hydra THV is a novel repositionable self-expanding system with supra-annular bovine pericardial leaflets. METHODS: The Hydra CE study was a premarket, prospective, multicenter, single-arm study conducted across 18 study centers in Europe and Asia-Pacific countries. The primary endpoint was all-cause mortality at 30 days. All endpoints were adjudicated by an independent clinical events committee. RESULTS: A total of 157 patients (79.2 ± 7.1 years of age, 58.6% female; Society of Thoracic Surgeons score 4.7 ± 3.4%) were enrolled. Successful implantation was achieved in 94.3% cases. At 30 days, there were 11 (7.0%) deaths, including 9 (5.7%) cardiovascular deaths, of which 5 (3.2%) were device related. At 1 year, there were 23 (14.6%) deaths, including 13 (8.3%) cardiovascular deaths. At 30 days, there were significant improvement of effective orifice area (from 0.7 ± 0.2 cm2 to 1.9 ± 0.6 cm2) and mean aortic valve gradient (from 49.5 ± 18.5 mm Hg to 8.1 ± 3.7 mm Hg), which were sustained up to 1 year. Moderate or severe paravalvular leak was observed in 6.3% of patients at 30 days and 6.9% of patients at 1 year. The rate of new permanent pacemaker implantation was 11.7% at 30 days and 12.4% at 1 year. CONCLUSIONS: The Hydra CE study demonstrated that transcatheter aortic valve replacement with Hydra THV offered favorable efficacy at 1 year, providing large effective orifice area and low transvalvular gradient as well as acceptable complication rates with regard to new permanent pacemaker and paravalvular leak. (A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve; NCT02434263).
Asunto(s)
Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Animales , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Bovinos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Diseño de Prótesis , Factores de Riesgo , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del TratamientoRESUMEN
Patients with isolated functional or recurrent tricuspid regurgitation are often denied surgery because they are considered to be at high risk. Transcatheter valve therapy provides a less invasive alternative for tricuspid regurgitation associated with right heart failure. We have evaluated the feasibility of transcatheter tricuspid valve implantation of the NaviGate valved stent in a long-term swine model. The valved stent was successfully implanted through transjugular and transatrial approaches on the beating heart with excellent hemodynamic and valve performance. No conduction disturbance or coronary obstruction was observed. This technology could provide an alternative treatment for patients who are at high surgical risk with severe tricuspid regurgitation and compromised right ventricular function.
Asunto(s)
Cateterismo Cardíaco , Cardiopatías/terapia , Tomografía Computarizada Multidetector , Anciano , Ecocardiografía Transesofágica , Endofuga/terapia , Femenino , Cardiopatías/diagnóstico por imagen , Implantación de Prótesis de Válvulas Cardíacas , Humanos , Persona de Mediana Edad , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/cirugía , Infarto del Miocardio/terapia , Dispositivo Oclusor SeptalRESUMEN
Right heart failure is a common presentation to both general physicians and cardiologists. Echocardiography is a useful investigation, and usually imaging of the liver is confined to helping estimate the right atrial pressure. We report a case of right heart failure where incidental imaging of the liver architecture during transoesophageal echocardiography helped in establishing the final diagnosis.
Asunto(s)
Cardiopatía Carcinoide/diagnóstico por imagen , Ecocardiografía Transesofágica , Cardiopatía Carcinoide/tratamiento farmacológico , Humanos , Masculino , Síndrome Carcinoide Maligno/diagnóstico por imagen , Síndrome Carcinoide Maligno/tratamiento farmacológico , Persona de Mediana Edad , Somatostatina/análogos & derivados , Somatostatina/uso terapéuticoRESUMEN
Both heavily calcified and ostial lesions are difficult to deal with by percutaneous transluminal coronary angioplasty (PTCA) alone. Acute results are often sub-optimal, complications are more frequent, and long-term results are disappointing. Optimal stent deployment may not be possible unless satisfactory lesion dilatation is achieved and the lesion made more compliant. The use of rotational atherectomy and cutting balloon angioplasty to a calcified ostial lesion in the left circumflex coronary artery prior to stent implantation is reported.