Clinical Outcomes With a Repositionable Self-Expanding Transcatheter Aortic Valve Prosthesis: The International FORWARD Study

Background Clinical outcomes in large patient populations from real-world clinical practice with a next-generation self-expanding transcatheter aortic valve are lacking. Objectives This study sought to document the clinical and device performance outcomes of transcatheter aortic valve replacement (TAVR) with a next-generation, self-expanding transcatheter heart valve (THV) system in patients with severe symptomatic aortic stenosis (AS) in routine clinical practice. Methods The FORWARD (CoreValve Evolut R FORWARD) study is a prospective, single-arm, multinational, multicenter, observational study. An independent clinical events committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions. An independent echocardiographic core laboratory evaluated all echocardiograms. From January 2016 to December 2016, TAVR with the next-generation self-expanding THV was attempted in 1,038 patients with symptomatic, severe AS at 53 centers on 4 continents. Results Mean age was 81.8 ± 6.2 years, 64.9% were women, the mean Society of Thoracic Surgeons Predicted Risk of Mortality was 5.5 ± 4.5%, and 33.9% of patients were deemed frail. The repositioning feature of the THV was applied in 25.8% of patients. A single valve was implanted in the proper anatomic location in 98.9% of patients. The mean aortic valve gradient was 8.5 ± 5.6 mm Hg, and moderate or severe aortic regurgitation was 1.9% at discharge. All-cause mortality was 1.9%, and disabling stroke occurred in 1.8% at 30 days. The expected-to-observed early surgical mortality ratio was 0.35. A pacemaker was implanted in 17.5% of patients. Conclusions TAVR using the next-generation THV is clinically safe and effective for treating older patients with severe AS at increased operative risk. (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369

Impact of COVID-19 Pandemic on TAVR Activity: A Worldwide Registry

Background: The COVID-19 pandemic had a considerable impact on the provision of structural heart intervention worldwide. Our objectives were: 1) to assess the impact of the COVID-19 pandemic on transcatheter aortic valve replacement (TAVR) activity globally; and 2) to determine the differences in the impact according to geographic region and the demographic, development, and economic status of diverse international health care systems. Methods: We developed a multinational registry of global TAVR activity and invited individual TAVR sites to submit TAVR implant data before and during the COVID-19 pandemic. Specifically, the number of TAVR procedures performed monthly from January 2019 to December 2021 was collected. The adaptive measures to maintain TAVR activity by each site were recorded, as was a variety of indices relating to type of health care system and national economic indices. The primary subject of interest was the impact on TAVR activity during each of the pandemic waves (2020 and 2021) compared with the same period pre–COVID-19 (2019). Results: Data were received from 130 centers from 61 countries, with 14 subcontinents and 5 continents participating in the study. Overall, TAVR activity increased by 16.7% (2,337 procedures) between 2018 and 2019 (ie, before the pandemic), but between 2019 and 2020 (ie, first year of the pandemic), there was no significant growth (–0.1%; –10 procedures). In contrast, activity again increased by 18.9% (3,085 procedures) between 2020 and 2021 (ie, second year of the pandemic). During the first pandemic wave, there was a reduction of 18.9% (945 procedures) in TAVR activity among participating sites, while during the second and third waves, there was an increase of 6.7% (489 procedures) and 15.9% (1,042 procedures), respectively. Further analysis and results of this study are ongoing and will be available at the time of the congress. Conclusion: The COVID-19 pandemic initially led to a reduction in the number of patients undergoing TAVR worldwide, although health care systems subsequently adapted, and the number of TAVR recipients continued to grow in subsequent COVID-19 pandemic waves. Categories: STRUCTURAL: Valvular Disease: Aorti

Plan de gestión integral de los residuos sólidos en los hospitales de la ciudad de Cartagena

Tesis (Administrador Industrial) -- Universidad de Cartagena. Facultad de Ciencias Económicas. Programa de Administración Industrial, 2007Las instituciones prestadoras de salud IPS y demás generadores de residuos hospitalarios, así como las personas que identifiquen separen, desactiven, empaquen, recolecten, transporten, almacenen, manejen, aprovechen, recuperen, transformen, traten y/o dispongan finalmente los residuos hospitalarios, desarrollan actividades de alto riesgo de contaminación dentro de su infraestructura física y fuera de ella, ya que el inadecuado manejo y disposición final de estos residuos se constituye en una fuente importante de contaminación de los recursos naturales y un factor de riesgo para la salud humana. Algunos residuos generados en los servicios de salud, son residuos peligrosos por su carácter infeccioso, reactivo, radiactivo, inflamable, entre otros, tales como los generados en las salas de atención de enfermedades infectocontagiosas, salas de emergencia, laboratorios clínicos, bancos de sangre, salas de maternidad, cirugía, morgues, radiología y demás. En Colombia se estima que tan solo en los hospitales de nivel 1, 2 y 3, sin contar las instituciones privadas y con base en el número de camas1, se generan aproximadamente 9.400 toneladas año de residuos hospitalarios y similares,2 los cuales son agentes causantes de la transmisión de enfermedades virales como la hepatitis B o C a través de lesiones con agujas hipodérmicas contaminadas con sangre humana infectada, generando riesgo para los trabajadores de la salud y para quienes manipulen este tipo de residuos tanto al interior como al exterior del establecimiento del generador

EL PROYECTO AUTONÓMICO CUBANO DE 1882 Y SUS IMPLICACIONES EN LA IDENTIDAD NACIONAL

Durante el siglo XIX, se manifestó claramente un movimiento político con tendencias autonómicas dentro del espectro político creado en Cuba. En los inicios del programa autonómico, hacia los primeros años de la centuria decimonónica, el pensamiento cubano carecía de un basamento práctico en el orden de un radicalismo independentista y el sentimiento de nacionalidad era incipiente. El estudio de dicho contexto histórico implica dilucidar una problemática medular que se erige sobre el análisis y significación del Autonomismo perteneciente al período entre guerras, con sus postulados predicantes todavía de una atadura a la metrópoli. En consonancia, este trabajo pretende centrar su atención, específicamente, en las implicaciones del proyecto autonómico de 1882 en la identidad nacional.proyecto autonómico cubano de 1882, identidad nacional

First Colombian tricuspid endovascular valve in valve using kissing balloon technique for failed bioprosthesis annular cracking

We present the first case in Colombia of tricuspid endovascular valve in valve for failed bioprosthesis in a 40-year-old patient with very high operative risk with great results, proposing kissing balloon annulus cracking technique as a practical solution for the Colombian specialists

Suprasternal direct aortic approach transcatheter aortic valve replacement avoids sternotomy and thoracotomy: first-in-man experience

Direct aortic deployment of a transcatheter aortic valve eliminates the need to traverse the aortic arch with the valve delivery system, enables placement of large sheaths in the aorta and innominate artery, provides maximal precision during deployment and ensures a safe, conventional surgical aortotomy closure. We describe the initial experience with the Suprasternal Aortic Access System (SuprAA System, Aegis Surgical Ltd, Dublin, Ireland) for direct transaortic/innominate valve delivery. Patients with severe, symptomatic aortic stenosis who were candidates for transcatheter aortic valve replacement (TAVR) via a direct transaortic approach were enrolled in the SuprAA-TAVR First-in-Man Study. Under general anaesthesia, the innominate artery and aortic arch were exposed in each patient, using the SuprAA System via a 2.5-cm incision directly above the sternal notch. The TAVR delivery sheath was positioned and the transcatheter valve deployed routinely under fluoroscopic guidance. Upon sheath removal, haemostasis at the aortotomy site was confidently secured using a double purse-string suture closure. All were extubated immediately. A meta-analysis of the direct aortic approach was done for comparison. Four male patients (mean 82.5 years) underwent SuprAA-TAVR (2 CoreValve; 2 SAPIEN). Anatomical visualization was excellent and suprasternal valve deployment was accurate regardless of sheath size with 100% Valve Academic Research Consortium-2 procedural success. The average total procedure time was 109.5 min without perioperative wound or vascular complications. The SuprAA System provides direct aortic/innominate access without sternal or thoracotomy incision. Patient recovery to normal activity is maximized, sheath size limitations are eliminated and valve deployment is precise. This innovative system creates a new and exciting minimally invasive approach for high-risk patients with aortic stenosis

Valve-in-Valve-in-Valve Transcatheter Aortic Valve Implantation to Treat a Degenerated Surgical Bioprosthesis in a Subaortic Position

Transcatheter aortic valve implantation for aortic stenosis has evolved as an alternative treatment for patients who are at high or excessive surgical risk. We report the case of an 84-year-old man with a degenerated surgically implanted valve in a subaortic position (9 mm below the native annulus) who underwent “valve-in-valve” transcatheter aortic valve implantation with use of a Medtronic CoreValve system. We planned to deploy the CoreValve at a conventional depth in the left ventricular outflow tract; we realized that this might result in paravalvular regurgitation, but it would also afford a “deep” landing site for a second valve, if necessary. Ultimately, we implanted a second CoreValve deep in the left ventricular outflow tract to seal a paravalvular leak. The frame of the first valve—positioned at the conventional depth—enabled secure anchoring of the second valve in a deeper position, which in turn effected successful treatment of the failing subaortic surgical prosthesis without paravalvular regurgitation

Implante valvular aórtico percutáneo

El propósito de este consenso es presentar un resumen de los principales estudios que han evaluado el implante valvular aórtico percutáneo como terapia alternativa en pacientes con estenosis aórtica sintomática severa, quienes no pueden ser sometidos a cirugía por un alto riesgo quirúrgico, o que se consideran inoperables por el “equipo cardiológico”, condiciones consideradas como indicación para dispositivos “off label”. Luego se describen métodos diagnósticos para la estenosis aórtica y ayudas para saber con cuál equipo de cardiología estructural contar en la planificación, se revisa el procedimiento y finalmente se mencionan las complicaciones y los riesgos del mismo