Biventricular assistance with 2 hm3 in a small chest patient: extra-pericardial implant.

We describe the clinical course and treatment of a 53-year-old female, with small chest dimensions, referred to our institution for a primary cardiogenic shock. The patient underwent an on-pump left ventricular assist-device (VAD) implantation with the aid of immediate post-operative paracorporeal right-VAD assistance for an acute right ventricular failure. After two unsuccessful weaning attempts, she underwent extrapericardial HM 3 RVAD implantation.

Outcomes after common arterial trunk repair: Impact of the surgical technique.

OBJECTIVES: We compared the risk of mortality and reintervention after common arterial trunk (CAT) repair for different surgical techniques, in particular the reconstruction of the right ventricle outflow tract with left atrial appendage (LAA) without a monocusp. METHODS: The study population comprised 125 patients with repaired CAT who were followed-up at our institution between 2000 and 2018. Statistical analysis included Cox proportional hazard models. RESULTS: Median follow-up was 10.6 years. The 10-year survival rate was 88.2% (95% confidence interval [CI], 80.6-92.4) with the poorest outcome for CAT type IV (64.3%; 95% CI, 36.8-82.3; P < .01). In multivariable analysis, coronary anomalies (hazard ratio [HR], 11.63 [3.84-35.29], P < .001) and CAT with interrupted aortic arch (HR, 6.50 [2.10-20.16], P = .001) were substantial and independent risk factors for mortality. Initial repair with LAA was not associated with an increased risk of mortality (HR, 0.37 [0.11-1.24], P = .11). The median age at reintervention was 3.6 years [7.3 days-13.1 years]. At 10 years, freedom from reintervention was greater in the group with LAA repair compared with the valved conduit group, 73.3% (95% CI, 41.3-89.4) versus 17.2% (95% CI, 9.2-27.4) (P < .001), respectively. Using a valved conduit for repair (HR, 4.79 [2.45-9.39], P < .001), truncal valve insufficiency (HR, 2.92 [1.62-5.26], P < .001) and DiGeorge syndrome (HR, 2.01 [1.15-3.51], P = .01) were independent and clinically important risk factors for reintervention. CONCLUSIONS: For the repair of CAT, the LAA technique for right ventricle outflow tract reconstruction was associated with comparable survival and greater freedom from reintervention than the use of a valved conduit.

Eficacia y seguridad del drenaje torácico de silicona acanalado en espiral después de la cirugía cardiaca y/o torácica / Efficacy and safety of corrugated spiral silicone chest drain after cardiac and/or thoracic surgery

INTRODUCCIÓN: El presente dictamen expone la evaluación de eficacia y seguridad del drenaje torácico de silicona acanalado en espiral, en comparación con el drenaje torácico convencional, en pacientes sometidos a cirugía cardiaca y/o torácica que requieren drenaje torácico postoperatorio. Un drenaje torácico es un tubo insertado a través de la pared torácica entre las costillas y dentro de la cavidad pleural para permitir el drenaje de aire o fluidos desde el tórax debido a una variedad de condiciones, como neumotórax, hemotórax, derrame pleural y situaciones posoperatorias, como las cirugías cardiacas y/o torácicas. El drenaje efectivo del espacio pleural requiere un drenaje colocado adecuadamente y un sistema de drenaje unidireccional. Los objetivos del drenaje torácico después de la cirugía cardiaca y/o pulmonar son monitorear el sangrado postoperatorio, extraer la sangre y el aire de los espacios mediastínicos y pleurales, permitir la expansión completa del pulmón, restablecer la mecánica ventilatoria correcta mediante la reinstitución de la presión intrapleural negativa, evaluar las fugas de aire o, en el caso de neumonectomía, el mantenimiento del mediastino en el eje. En EsSalud, los drenajes torácicos postoperatorios son realizados con tubos torácicos semirrígidos (cloruro de polivinilo siliconizado) de gran calibre (28 a 36 Fr), sin embargo, se postula que los tubos torácicos de silicona acanalados en espiral de pequeño calibre (19 o 24 Fr) podrían conferir un beneficio adicional en términos de nivel de dolor en los pacientes después de la cirugía cardiotorácica. METODOLOGÍA: Se realizó una búsqueda sistemática de literatura con el objetivo de identificar evidencia sobre la eficacia y seguridad del drenaje torácico de silicona acanalado en espiral, en comparación con el drenaje torácico convencional, en pacientes sometidos a cirugía cardiaca y/o torácica que requieren drenaje torácico postoperatorio. Se utilizaron las bases de datos PubMed, Cochrane Library y LILACS, priorizándose la evidencia proveniente de ensayos clínicos controlados aleatorizados. Asimismo, se realizó una búsqueda dentro de bases de datos pertenecientes a grupos que realizan evaluación de tecnologías sanitarias (ETS) y guías de práctica clínica (GPC), incluyendo el Healthcare Improvement Scotland, el National Institute for Health and Care Excellence (NICE), la Canadian Agency for Drugs and Technologies in Health (CADTH), la Haute Autorité de Santé (HAS), el Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG), además de la Base Regional de Informes de Evaluación de Tecnologías en Salud de las Américas (BRISA) y páginas web de sociedades especializadas en cirugía torácica y cardiovascular o manejo de enfermedades pulmonares como British Thoracic Society, American Thoracic Society, American College of Chest Physicians, European Society of Thoracic Surgeons, y Enhanced Recovery After Surgery Society. Además, se realizó una búsqueda de literatura gris en el motor de búsqueda Google, a fin de poder identificar GPC y ETS de relevancia que pudiesen haber sido omitidas por la estrategia de búsqueda o que no hayan sido publicadas en las bases de datos consideradas. Se hizo una búsqueda adicional en la página web del Registro administrado por la Biblioteca Nacional de Medicina de los Estados Unidos (https://clinicaltrials.gov/) e International Clinical Trial Registry Platform (ICTRP) (https://apps.who.int/trialsearch/), para poder identificar ensayos clínicos en curso o que no hayan sido publicados para, de este modo, disminuir el riesgo de sesgo de publicación. La búsqueda sistemática se basó en una metodología escalonada, la cual consistió en la búsqueda inicial de estudios secundarios (tipo revisiones sistemáticas de ensayos clínicos) que respondan a la pregunta PICO, seguido de la búsqueda de estudios primarios (tipo ensayos clínicos aleatorizados). RESULTADOS: Se realizó una búsqueda de la literatura con respecto a la eficacia y seguridad del drenaje torácico de silicona acanalado en espiral, en comparación con el drenaje torácico convencional, en pacientes sometidos a cirugía cardiaca y/o torácica que requieren drenaje torácico postoperatorio. A continuación, se describe la evidencia disponible según el orden jerárquico del nivel de evidencia o pirámide de Haynes 6S6, siguiendo lo indicado en los criterios de elegibilidad. CONCLUSIONES: El presente dictamen preliminar tuvo como objetivo evaluar la mejor evidencia sobre la eficacia y seguridad del drenaje torácico de silicona acanalado en espiral, en comparación con el drenaje torácico convencional, en pacientes sometidos a cirugía cardiaca y/o torácica que requieren drenaje torácico postoperatorio. Los desenlaces de interés fueron el volumen de sangre evacuado por día, la restauración de la presión negativa intratorácica, el nivel de dolor, el tiempo hasta el retiro del drenaje, la mortalidad y los eventos adversos. La evidencia de una único ECA que evaluó los drenajes torácicos de silicona acanalados en espiral en comparación con los drenajes torácicos convencionales después de la cirugía torácica es exploratoria y no permite realizar conclusiones sobre la eficacia y seguridad comparativa de ambos dispositivos considerando el alto riesgo de sesgo detectado, que podría influenciar significativamente en los resultados del estudio. Además, la evidencia de un estudio observacional alerta sobre la ocurrencia de eventos adversos asociados con la insuficiencia en la evacuación del aire, así como también de casos de rupturas de drenajes durante las maniobras de extracción. Así, se concluye que con la evidencia disponible al momento no es posible afirmar que exista un beneficio neto asociado con el uso de los drenajes torácicos de silicona acanalados en espiral. Además, los resultados de los estudios incluidos en la presente evaluación advierten sobre la posible ocurrencia de eventos adversos de relevancia clínica para el paciente, asociados con el uso del dispositivo de interés, lo que genera incertidumbre respecto a la seguridad del dispositivo. De este modo, se requieren ECA bien diseñados y con adecuado tamaño de muestra que permitan determinar de manera rigurosa si existen diferencias clínicamente importantes entre el uso de drenajes de silicona acanalados en espiral y el uso de drenajes convencionales después de la cirugía cardiaca y/o torácica. Por lo expuesto, el IETSI no aprueba la incorporación del drenaje torácico de silicona acanalado en espiral al catálogo de bienes de EsSalud.

A generalized predictive control for remote cardiovascular surgical systems.

Robot-assisted cardiovascular surgery is used to avoid surgeon suffering from X-ray radiation and relieve fatigue caused by long-time standing wearing protective clothing. Its remote surgery can alleviate the lack of experienced doctors in remote areas. Due to the existence of time-delay phenomena, flexible deformation and nonlinearity of interventional instruments, it is difficult to ensure system transparency. This paper analyzes the evaluation index of system transparency. A generalized predictive control (GPC) is developed to suppress the effect of time-varying delay and parameter identification error. Moreover, a terminal sliding mode controller (SMC) is designed to improve the robustness of the system under consideration. Simulation results are provided to show that the proposed control strategy can improve transparency of the remote vascular interventional surgery system.

Lesão aguda da parede arterial provocada pelo método de interrupção temporária de fluxo em diferentes vias de cirurgia aórtica: estudo morfológico e biomecânico da aorta de porcos / Acute aortic wall injury caused by aortic cross-clamping: morphological and biomechanical study of the aorta in a swine model of three aortic surgery approaches

Resumo Contexto O clampeamento aórtico e a oclusão da aorta com balão poderiam levar a lesões na parede aórtica. Objetivo O objetivo deste estudo foi verificar as alterações da parede aórtica relacionadas ao método de interrupção de fluxo (cample ou balão) em diferentes técnicas disponíveis para cirurgia de aorta. Métodos Os experimentos foram realizados em 40 porcos fêmeas pesando de 25-30 kg, alocados para quatro grupos: S (n = 10), nenhuma intervenção (sham); C (n = 10), laparotomia mediana transperitoneal para acesso à aorta abdominal infrarrenal com tempo de clampeamento de 60 minutos; L (n = 10), cirurgia laparoscópica da aorta abdominal infrarrenal com tempo de clampeamento de 60 minutos; EV (n = 10), controle aórtico proximal com inserção de cateter-balão para oclusão aórtica por acesso femoral, inflado a fim de promover oclusão aórtica contínua por 60 minutos. Após a eutanásia, as aortas foram removidas e seccionadas para obtenção de espécimes histológicos destinados a análises morfométricas e por microscopia de luz. Os fragmentos longitudinais restantes foram estirados até a ruptura, e determinaram-se padrões mecânicos. Resultados Observou-se redução do limite de proporcionalidade da aorta abdominal, diminuição da rigidez e da carga de ruptura nos grupos submetidos a campleamento aórtico (C e L) em comparação ao grupo EV. Conclusões O campleamento aórtico durante cirurgia aberta ou laparoscópica pode afetar as propriedades mecânicas da aorta, ocasionando redução de resistência da parede aórtica sem desencadear alterações na estrutura histológica da parede aórtica.

Abstract Background Aortic cross-clamping and balloon occlusion of the aorta could lead to damage to the aorta wall. Objective The aim of this study was to investigate changes to the aorta wall related to the method used to interrupt flow (clamping or balloon) in the different techniques available for aortic surgery. Methods Experiments were performed on 40 female pigs, weighing 25-30kg, which were randomly allocated to 4 study groups: S (n=10), no intervention (sham group); C (n=10), midline transperitoneal laparotomy for infrarenal abdominal aortic access with 60 min of cross-clamping; L (n=10), laparoscopic infrarenal abdominal aortic surgery with 60 min of cross-clamping; EV (n=10), remote proximal aortic control with transfemoral arterial insertion of aortic occlusion balloon catheter, inflated to provide continued aortic occlusion for 60min. After euthanasia, the aortas were removed and cross-sectioned to obtain histological specimens for light microscopic and morphometric analyses. The remaining longitudinal segments were stretched to rupture and mechanical parameters were determined. Results We observed a reduction in the yield point of the abdominal aorta, decrease in stiffness and in failure load in the aortic cross-clamping groups (C and L) compared with the EV group. Conclusions Aortic cross-clamping during open or laparoscopic surgery can affect the mechanical properties of the aorta leading to decrease in resistance of the aorta wall, without structural changes in aorta wall histology.

A Flow Induced Autoimmune Response and Accelerated Senescence of Red Blood Cells in Cardiovascular Devices.

Red blood cells (RBCs) passing through heart pumps, prosthetic heart valves and other cardiovascular devices undergo early senescence attributed to non-physiologic forces. We hypothesized that mechanical trauma accelerates aging by deformation of membrane proteins to cause binding of naturally occurring IgG. RBCs isolated from blood of healthy volunteers were exposed to high shear stress in a viscometer or microfluidics channel to mimic mechanical trauma and then incubated with autologous plasma. Increased binding of IgG was observed indicating forces caused conformational changes in a membrane protein exposing an epitope(s), probably the senescent cell antigen of band 3. The binding of immunoglobulin suggests it plays a role in the premature sequestration and phagocytosis of RBCs in the spleen. Measurement of IgG holds promise as a marker foreshadowing complications in cardiovascular patients and as a means to improve the design of medical devices in which RBCs are susceptible to sublethal trauma.

Defibrillator-Heart Pump: An Implantable Ventricular Assist Device With Integrated Defibrillator Component-The First In Vitro Testing.

Left ventricular assist devices (LVADs) are an important therapeutic option for patients with end-stage heart failure waiting for heart transplantation or in older patients as definite therapy for heart failure. Interestingly, about 62% of patients receiving LVADs do not have an automatic implantable cardioverter-defibrillator (AICD) at the time of implantation, although these patients have increased risk of being confronted with dangerous arrhythmia. Therefore, an LVAD system including AICD function is a reasonable alternative for such heart failure patients thereby avoiding a second surgical intervention for AICD implantation. In this article, a newly developed system including LVAD and AICD function is introduced, and we also report its first in vitro testing.

Robotic repair of left-sided partial anomalous pulmonary venous connection to the coronary sinus.

Left-sided partial anomalous pulmonary venous connection to the coronary sinus is a rare congenital cardiac defect. Surgical repair is indicated to prevent cardiopulmonary morbidities that may occur in later age. Although the conventional median sternotomy or thoracotomy incisions are used during surgical repair, robotic surgery can be a feasible alternative approach to this pathology. In this case, we report a 14-year-old child, who was diagnosed with left partial anomalous pulmonary venous connection to the coronary sinus. A total endoscopic robotic repair was successfully done via right atriotomy approach. After routing of the pulmonary venous return from the left lung to the left atrium, the interatrial septum was reconstructed with a pericardial patch. We report a successful use of totally endoscopic robotic approach in a patient diagnosed with left-sided partial anomalous pulmonary venous connection.

Quality of reporting in randomized controlled trials of therapeutic cardiovascular medical devices.

BACKGROUND: Therapeutic medical devices play an important role in the treatment of cardiovascular diseases. The reliability of the randomized controlled trial, which is the best design for assessing treatment effects, largely depends on the information found in published reports. Limited information regarding the quality of reporting about therapeutic medical devices in trials was provided. METHOD: A cross-sectional study was conducted to assess the reporting quality of randomized controlled trials that tested the effects of therapeutic cardiovascular medical devices. The quality of reporting was assessed against a modified Consolidated Standards of Reporting Trials checklist, including 47 items from the Consolidated Standards of Reporting Trials statement and Consolidated Standards of Reporting Trials extension. We also examined the specific items regarding medical devices. Univariable and multivariable linear regressions were undertaken to explore potential factors associated with Consolidated Standards of Reporting Trials scores. RESULT: Some 115 randomized controlled trials were identified. The mean (standard deviation) Consolidated Standards of Reporting Trials score was 20.5 (5.0). The extent of compliance with the Consolidated Standards of Reporting Trials reporting guideline differed substantially across items: 5 of the 47 items were reported adequately across trials (more than 90%), and 10 were reported adequately in less than 5% of trials. Less than 50% of the trials reported additional items related to the medical device. Multivariable regression analysis showed that trials published in general journals (coefficient 7.44, 95% confidence interval [CI]: 5.50-9.38), with larger sample sizes (coefficient 2.30, 95% CI: 0.76-3.83), and multiple-center studies (coefficient 3.14, 95% CI: 1.27-5.01) were associated with a higher quality of reporting. CONCLUSION: The overall reporting quality in randomized controlled trials of therapeutic medical device trials is suboptimal, particularly in terms of items regarding surgeons and hospitals. We suggest that the existing Consolidated Standards of Reporting Trials and extension should be modified to be more applicable to therapeutic medical devices.

Safety and efficacy of the reducer: A multi-center clinical registry - REDUCE study.

BACKGROUND: The coronary sinus (CS) Reducer is a novel device designed to aid in the management and to improve quality of life of patients with severe angina symptoms refractory to optimal medical and interventional therapies. This study aims to assess the safety and efficacy of the Reducer in a real-world cohort of patients presenting with refractory angina. METHODS: One hundred forty-one consecutive patients were treated with CS Reducer implantation. The primary efficacy endpoint was reduction in angina symptoms from baseline as assessed by Canadian Cardiovascular Society (CCS) class status and Seattle Angina Questionnaire (SAQ) scores. The primary safety endpoint was successful Reducer device delivery and deployment in the absence of any device-related events. RESULTS: Procedural success was achieved in 139 (98.6%) patients. Reducer implantation was not obtained in 2 (1.4%) patients because of unfavorable anatomy of the CS. There were no CS perforations, cardiac tamponade, peri-procedural death or myocardial infarction during a median follow-up of 14 months (range from 6- to 70-month). In patients undergoing Reducer implantation, mean CCS class improved from 3.05 ±â€¯0.53 at baseline to 1.63 ±â€¯0.98 at follow-up (p < 0.001). Overall, 113 (81%) patients experienced at least 1 CCS improvement, and 63 (45%) patients at least 2 CCS-class improvement. All SAQ items improved significantly (p < 0.001 for all) and translated into a significant reduction in the mean number of anti-ischemic drugs prescribed (2.37 ±â€¯0.97 vs 2.17 ±â€¯0.95; p = 0.003). CONCLUSIONS: In a real-world multi-center experience, implantation of the CS Reducer appears safe, and efficacious in reducing symptoms of angina and improving quality of life.

[Modern polyurethanes in cardiovascular surgery]. / Sovremennye poliuretany v serdechno-sosudistoi khirurgii.

Currently, there is great clinical demand for synthetic tissue-engineered cardiovascular prostheses with good long-term patency. Polyurethanes belong to the class of polymers with excellent bio- and hemocompatibility. They are known to possess good mechanical properties, but are prone to processes of degradation in conditions of functioning in living organisms. Attempts at solving this problem have resulted in the development of various new subclasses of polyurethanes such as thermoplastic polyether polyurethanes, polyurethanes with a silicone segment, polycarbonate polyurethanes and nanocomposite polyurethanes. This was accompanied and followed by offering a series of new technologies of production of implantable medical devices such as vascular grafts, heart valves and others. In the presented review, we discuss biological and mechanical properties of modern subclasses of polyurethanes, as well as modern methods of manufacturing implantable medical devices made of polyurethanes, especially small-diameter vascular prostheses.

Intraoperative customized double-patch device with twin sutures for multiple muscular septal defects.

OBJECTIVES: Closure of multiple muscular ventricular septal defects (VSDs) remains a challenge because of anatomical complexity. METHODS: We mapped all the VSDs using en face reconstruction of the right ventricular septal surface through echocardiography and then performed an 'Intraoperative Customized Double-Patch Device' technique to surgically close them in 39 patients (male:female = 25:14). The median age of the patients was 6 months (2 months-10 years), and mean weight was 5.98 ± 4.21 kg. A patch of polytetrafluoroethylene was placed on the left ventricular side of the defect and another on the right ventricular side, and they were anchored to each other using 2 polypropylene sutures. Residual shunts were evaluated using intraoperative echocardiography and measurements of right atrial-pulmonary arterial saturation were taken in all patients. RESULTS: The distribution of muscular VSDs was as follows: anterior muscular 12, posterior muscular 18, mid-muscular 11 and apical 9. The associated lesions included perimembranous VSD (n = 28), tetralogy of Fallot (n = 6), double-outlet right ventricle (n = 2) and supramitral membrane (n = 2). Mean clamp time and bypass time were 93 ± 19 min and 147 ± 26 min, respectively. Mean hospital stay was 11 ± 3.39 days with no in-hospital mortality. Five patients with significant residual shunts needed concomitant PA banding. All patients remained in New York Heart Association Class I. There was either no residual shunt (n = 3) or trivial shunt (n = 2) among the banded patients. All patients remained symptom-free and continued to thrive well at the most recent follow-up (3.48 ± 1.51 years). CONCLUSIONS: Muscular VSDs can be mapped through en face reconstruction and closed using intraoperative customized double-patch device technique in a variety of situations with satisfactory immediate and short-term results.

The Reducer device in patients with angina pectoris: mechanisms, indications, and perspectives.

Despite available pharmacological and interventional therapies, refractory angina is a common and disabling clinical condition, and a major public health problem, which affects patients' quality-of-life, and has a significant impact upon health care resources. Persistent angina is common not only in patients who are not good candidates for revascularization, but also in patients following successful revascularization. Clearly, there is a need for additional treatment options for refractory angina beyond currently available pharmacological and interventional therapies. It is of pivotal importance, in this condition, to practice a patient-centred health assessment approach, measuring success of a new therapy by its effects on patients' symptoms, functional status, and quality-of-life, rather than hard clinical endpoints as used in clinical studies. The coronary sinus Reducer is a novel technology designed to reduce disabling symptoms and improve quality-of-life of patients suffering from refractory angina. This review serves to update the clinician as to current evidence and future perspectives of the optimal utilization of this innovative technology.

Adoption Decisions for Medical Devices in the Field of Cardiology: Results from a European Survey.

Decisions to adopt medical devices at the hospital level have consequences for health technology assessment (HTA) on system level and are therefore important to decision makers. Our aim was to investigate the characteristics of organizations and individuals that are more inclined to adopt and utilize cardiovascular devices based on a comprehensive analysis of environmental, organizational, individual, and technological factors and to identify corresponding implications for HTA. Seven random intercept hurdle models were estimated using the data obtained from 1249 surveys completed by members of the European Society of Cardiology. The major findings were that better manufacturer support increased the adoption probability of 'new' devices (i.e. in terms of CE mark approval dates), and that budget pressure increased the adoption probability of 'old' devices. Based on our findings, we suggest investigating the role of manufacturer support in more detail to identify diffusion patterns relevant to HTA on system level, to verify whether it functions as a substitute for medical evidence of new devices, and to receive new insights about its relationship with clinical effectiveness and cost-effectiveness. © 2017 The Authors. Health Economics published by John Wiley & Sons, Ltd.

[IMAGING SUPPORT SYSTEMS FOR CARDIOVASCULAR SURGERY].

Because of its low invasiveness, endovascular aneurysmal repair was established as a new method of treatment for aortic aneurysms, revolutionizing the treatment of this condition. With the continuing development of technology and devices, endovascular aneurysmal repair has become safer than before. Innovations in imaging support systems including navigation systems have contributed greatly to the development of endovascular procedures, making transcatheter aortic valve implantation a safe surgical option. We discuss such innovations and the future development of imaging support systems for safe cardiovascular surgery.

Medical Devices; Cardiovascular Devices; Classification of the Apical Closure Device. Final order.

The Food and Drug Administration (FDA) is classifying the apical closure device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the apical closure device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.