Experience achieved after implementation of the Veno-Venous ExtraCorporeal Membrane Oxygenation(ECMO) retrieval program in the region of Madrid (Spain). Hospital Universitario 12 de Octubre

Objectives: The objetive of this study is to describe the cases trasferred to an ECMO referral;s centre (Hospital Universitario 12 de Octubre, Madrid (Spain)), to investigate characteristics before ECMO and while the patient was on ECMO, to analyse the presence or not of complications secondary to transfer and cannulation and finally to analyse the ICU outcome. Method(s): This is a Prospective study done from November 1st, 2020 to December 31st, 2022. The cases were accepted either for emergency ECMO cannulation in the hospital of origin and retrieval or for conventional transfer. We analysed basic decriptive variables such as male proportion, age, IMC and etiology of ARDS and variables before ECMO such as prone position, duration of non-invasive ventilation, invasive ventilation and ICU leght of stay before ECMO. We recorded ELSO, SOFA and APACHE Severity Scores. We also analysed several variables on ECMO: if prone position on ECMO was done, median days of ECMO and succesfull weaning from ECMO. We also recorded whether there were complications or not in the transfer and cannulation. Finally ICU survival was examined. Result(s): 31 cases were accepted. 22 (71 %) were male. 29 cases were accepted for emergency ECMO cannulation. Median age was 47 years and IMC 31.1. The etiology of SDRA was COVID 19 infection in 23 cases (74% cases). Lenght of non invasive and invasive ventilation before ECMO were 4 days and 3 days respectively and lenght of ICU admission before ECMO was 2 days. Prone position was 1 day and 2 prone sessions were done before ECMO. Severity scores: APACHE 10 , SOFA 4 , ELSO 3 . On ECMO Prone position was done on 15 cases(48.4%) . Median days on ECMO were 13.5 days. Succesfull weaning from ECMO were achieved on 20 cases(61%), 2 cases remain on ECMO. No complications were seen on transfer or cannulation. ICU Survivors were 16(51.6%). Conclusion(s): After 2 years of experience on ECMO retrieval in the region of Madrid ECMO availability was achieved. Our results are similar than ELSO mortality.

Lessons from COVID-19 for future disasters: an opinion paper.

A "Pandemic/Disaster Law" is needed to condense and organize the current dispersed and multiple legislation. The State must exercise a single power and command appropriate to each situation, with national validity. The production of plans for the use of land and real estate as potential centers for health care, shelter or refuge is recommended. There should be specific disaster plans at least for Primary Health Care, Hospitals and Socio-sanitary Centers. The guarantee of the maintenance of communication and supply routes is essential, as well as the guarantee of the autochthonous production of basic goods. The pandemic has highlighted the need to redefine the training plans for physicians who, in their different specialties, have to undertake reforms that allow a more versatile and transversal training. National research must have plans to be able to respond quickly to questions posed by the various crises, using all the nation's resources and in particular, all the data and capabilities of the health sector. Contingency plans must consider ethical aspects, and meet the needs of patients and families with a humanized approach. In circumstances of catastrophe, conflicts increase and require a bioethical response that allows the best decisions to be made, with the utmost respect for people's values. Rapid, efficient and truthful communication systems must be contained in a special project for this sector in critic circumstances. Finally, we believe that the creation of National Coordination Centers for major disasters and Public Health can contribute to better face the crises of the future.

Insights for COVID-19 in 2023.

Predictions for a near end of the pandemic by the World Health Organization should be interpreted with caution. Current evidence indicates that the efficacy of a fourth dose of classical mRNA vaccines (BT162b2 or mRNA-1273) is low and short-lived in preventing SARS-CoV-2 infection in its predominant variant (Omicron). However, its efficacy is high against severe symptomatic infection, hospitalization and death. The new vaccines being introduced are bivalent and active against the Omicron variants. Potential new vaccines to be introduced in the coming year include a vaccine based on a recombinant protein that emulates the receptor binding domain of the Spike protein under development by the Spanish company Hipra, as well as vaccines for nasal or oral administration. Available information suggests that vaccines against COVID-19 can be administered in association with influenza vaccination without particular complications. New drugs against COVID-19, both antiviral and anti-inflammatory, are under investigation, but this does not seem to be the case with monoclonal antibodies. The indication to use masks in some circumstances will be maintained next year in view of the accumulation of scientific data on their efficacy. Finally, the long COVID or Post-COVID syndrome may continue to affect a very high proportion of patients who have had the disease, requiring combined diagnostic and therapeutic resources.

COVID in Pediatric Age: an opinion paper.

The incidence of COVID in pediatrics was underestimated during the first months of the pandemic due to the oligosymptomatic nature of the infection in many children and the scarcity of diagnostic tests applied to this population. It is now accepted that children are infected and transmit the disease in the same way as adults. On the contrary, children have less severe and less lethal COVID, probably due to a lower maturity of the child's immune system, a lower number of ACE2 receptors and the lower presence of comorbidities in this population group. The development of a multisystemic inflammatory syndrome after SARS-CoV-2 infection in children, despite its rarity, is a very serious condition that frequently requires intensive care. Other less severe post-COVID manifestations have been described in children but are not yet well defined. COVID has had and continues to have a significant psychological impact on the children themselves, on their caregivers and on the exacerbation of pre-existing psychiatric conditions. We apply adult therapeutic principles to children but with very low levels of evidence. Information on the tolerability of the available medications in this population group is still scarce. The mortality of COVID in children is very low and generally affects children with significant comorbidities. There are, at present, three vaccines licensed for pediatric use which are compatible with all other vaccines applicable to children. In these circumstances, there has been much speculation about the indication for vaccination in the pediatric age group, but given its good tolerance, there are clinical and ethical reasons that, in our opinion, justify it.

COVID-19: Some unresolved issues.

Two years after the COVID-19 pandemic, many uncertainties persist about the causal agent, the disease and its future. This document contains the reflection of the COVID-19 working group of the Official College of Physicians of Madrid (ICOMEM) in relation to some questions that remain unresolved. The document includes considerations on the origin of the virus, the current indication for diagnostic tests, the value of severity scores in the onset of the disease and the added risk posed by hypertension or dementia. We also discuss the possibility of deducing viral behavior from the examination of the structure of the complete viral genome, the future of some drug associations and the current role of therapeutic resources such as corticosteroids or extracorporeal oxygenation (ECMO). We review the scarce existing information on the reality of COVID 19 in Africa, the uncertainties about the future of the pandemic and the status of vaccines, and the data and uncertainties about the long-term pulmonary sequelae of those who suffered severe pneumonia.

Pharmacological treatment of COVID-19: an opinion paper.

The precocity and efficacy of the vaccines developed so far against COVID-19 has been the most significant and saving advance against the pandemic. The development of vaccines has not prevented, during the whole period of the pandemic, the constant search for therapeutic medicines, both among existing drugs with different indications and in the development of new drugs. The Scientific Committee of the COVID-19 of the Illustrious College of Physicians of Madrid wanted to offer an early, simplified and critical approach to these new drugs, to new developments in immunotherapy and to what has been learned from the immune response modulators already known and which have proven effective against the virus, in order to help understand the current situation.

Impact of the COVID-19 pandemic on the diagnosis and treatment of onco-hematologic patients: a discussion paper.

We do not know the precise figure for solid organ tumors diagnosed each year in Spain and it is therefore difficult to calculate whether there has been a decrease in cancer diagnoses as a consequence of the pandemic. Some indirect data suggest that the pandemic has worsened the stage at which some non-hematological neoplasms are diagnosed. Despite the lack of robust evidence, oncology patients seem more likely to have a poor outcome when they contract COVID-19. The antibody response to infection in cancer patients will be fundamentally conditioned by the type of neoplasia present, the treatment received and the time of its administration. In patients with hematological malignancies, the incidence of infection is probably similar or lower than in the general population, due to the better protective measures adopted by the patients and their environment. The severity and mortality of COVID-19 in patients with hematologic malignancies is clearly higher than the general population. Since the immune response to vaccination in hematologic patients is generally worse than in comparable populations, alternative methods of prevention must be established in these patients, as well as actions for earlier diagnosis and treatment. Campaigns for the early diagnosis of malignant neoplasms must be urgently resumed, post-COVID manifestations should be monitored, collaboration with patient associations is indisputable and it is urgent to draw the right conclusions to improve our preparedness to fight against possible future catastrophes.

New variants of SARS-CoV-2.

The emergence and spread of new variants of SARS-CoV-2 has produced enormous interest due to their possible implication in the improved transmissibility of the virus, their consequences in the individual evolution of the infection, as well as in the possible escape from the immunity generated by the current vaccines. The variants that attract most attention are those of public health concern, including B.1.1.7 (UK), P.1 (Brazilian) and B.1.351 (South African). This list is extended by the variants of interest that emerge and are expanding in certain countries but are found sporadically in others, such as B.1.427 and B.1.429 (Californians) or B.1.617 (Indian). Whole genome sequencing or strategies specifically targeting the spicule gene are used in the microbiology laboratories for characterization and detection. The number of infected individuals, the sanitary situation of each country, epidemiological measures and vaccination strategies influence its dispersion and new variants are expected to emerge. This emergence can only be avoided today by increasing the vaccinated population in all countries and by not relaxing epidemiological containment measures. It is not excluded that in the future it will be necessary to revaccinate against new variants.

Recommendations for the management of critically ill patients with COVID-19 in Intensive Care Units☆ Recomendaciones para el manejo de los pacientes críticos con COVID-19 en las Unidades de Cuidados Intensivos

The COVID-19 pandemic has led to the admission of a high number of patients to the ICU, generally due to severe respiratory failure. Since the appearance of the first cases of SARS-CoV-2 infection, at the end of 2019, in China, a huge number of treatment recommendations for this entity have been published, not always supported by sufficient scientific evidence or with methodological rigor necessary. Thanks to the efforts of different groups of researchers, we currently have the results of clinical trials, and other types of studies, of higher quality. We consider it necessary to create a document that includes recommendations that collect this evidence regarding the diagnosis and treatment of COVID-19, but also aspects that other guidelines have not considered and that we consider essential in the management of critical patients with COVID-19. For this, a drafting committee has been created, made up of members of the SEMICYUC Working Groups more directly related to different specific aspects of the management of these patients.

Recommendations for the management of critically ill patients with COVID-19 in Intensive Care Units.

The COVID-19 pandemic has led to the admission of a high number of patients to the ICU, generally due to severe respiratory failure. Since the appearance of the first cases of SARS-CoV-2 infection, at the end of 2019, in China, a huge number of treatment recommendations for this entity have been published, not always supported by sufficient scientific evidence or with methodological rigor necessary. Thanks to the efforts of different groups of researchers, we currently have the results of clinical trials, and other types of studies, of higher quality. We consider it necessary to create a document that includes recommendations that collect this evidence regarding the diagnosis and treatment of COVID-19, but also aspects that other guidelines have not considered and that we consider essential in the management of critical patients with COVID-19. For this, a drafting committee has been created, made up of members of the SEMICYUC Working Groups more directly related to different specific aspects of the management of these patients.

Booster or additional vaccination doses in patients vaccinated against COVID-19.

Several health organizations, mainly in Western countries, have recently authorized the use of a booster dose of the COVID-19 vaccine for patients previously vaccinated with mRNA vaccines, with criteria that do not always coincide. The COVID Scientific Committee of the Illustrious College of Physicians of Madrid (ICOMEM) has received and asked several questions about this situation, to which the group has tried to give answers, after deliberation and consensus. The efficacy of the vaccines administered so far is beyond doubt and they have managed to reduce, fundamentally, the severe forms of the disease. The duration of this protection is not well known, is different in different individuals and for different variants of the virus and is not easily predictable with laboratory tests. Data on the real impact of a supplementary or "booster" dose in the scientific literature are scarce for the moment and its application in large populations such as those in the state of Israel may be associated with a decrease in the risk of new and severe episodes in the short observation period available. We also lack sufficient data on the safety and potential adverse effects of these supplementary doses and we do not know the ideal time to administer them in different situations. In this state of affairs, it seems prudent to administer supplemental doses to those exposed to a higher risk, such as immunocompromised individuals and the elderly. On the other hand, we consider that this is not the time to accelerate, on the spur of the moment, a massive administration of a third dose to other population groups that are less exposed and at lower risk, without waiting for adequate scientific information, which will undoubtedly arrive gradually. We do not believe that this position is incompatible with the practical and ethical warnings made by the World Health Organization in this respect.

Actions and attitudes on the immunized patients against SARS-CoV-2.

The access to COVID vaccines by millions of human beings and their high level of protection against the disease, both in its mild and severe forms, together with a plausible decrease in the transmission of the infection from vaccinated patients, has prompted a series of questions from the members of the College of Physicians of Madrid (ICOMEM) and the society. The ICOMEM Scientific Committee on this subject has tried to answer these questions after discussion and consensus among its members. The main answers can be summarized as follows: The occurrence of new SARS-CoV-2 infections in both vaccinated and previously infected patients is very low, in the observation time we already have. When breakthrough infections do occur, they are usually asymptomatic or mild and, purportedly, should have a lower capacity for transmission to other persons. Vaccinated subjects who have contact with a SARS-CoV-2 infected patient can avoid quarantine as long as they are asymptomatic, although this decision depends on variables such as age, occupation, circulating variants, degree of contact and time since vaccination. In countries with a high proportion of the population vaccinated, it is already suggested that fully vaccinated persons could avoid the use of masks and social distancing in most circumstances. Systematic use of diagnostic tests to assess the immune response or the degree of protection against reinfection after natural infection or vaccination is discouraged, since their practical consequences are not known at this time. The existing information precludes any precision regarding a possible need for future revaccination. This Committee considers that when mass vaccination of health care workers and the general population is achieved, SARS-CoV-2 screening tests could be avoided at least in outpatient care and in the case of exploratory procedures that do not require hospitalization.

Persistence and viability of SARS-CoV-2 in primary infection and reinfections.

Since the beginning of the SARS-CoV-2 epidemic, virus isolation in the infected patient was only possible for a short period of time and it was striking that this occurred constantly and did not provide guidance on the clinical course. This fact led to confusion about the efficacy of some of the drugs initially used, which seemed to have a high efficiency in viral clearance and proved ineffective in modifying the course of the disease. The immune response also did not prove to be definitive in terms of evolution, although most of the patients with very mild disease had a weak or no antibody response, and the opposite was true for the most severe patients. With whatever the antibody response, few cases have been re-infected after a first infection and generally, those that have, have not reproduced a spectrum of disease similar to the first infection. Among those re-infected, a large number have been asymptomatic or with very few symptoms, others have had a moderate picture and very few have had a poor evolution. Despite this dynamic of rapid viral clearance, laboratory tests were still able to generate positive results in the recovery of genomic sequences and this occurred in patients who were already symptom-free, in others who were still ill and in those who were very seriously ill. There was also no good correlate. For this reason and with the perspective of this year and the half of pandemic, we compiled what the literature leaves us in these aspects and anticipating that, as always in biology, there are cases that jump the limits of the general behavior of the dynamics of infection in general.

[Recommendations for the management of critically ill patients with COVID-19 in Intensive Care Units]. / Recomendaciones para el manejo de los pacientes críticos con COVID-19 en las Unidades de Cuidados Intensivos.

The COVID-19 pandemic has led to the admission of a high number of patients to the ICU, generally due to severe respiratory failure. Since the appearance of the first cases of SARS-CoV-2 infection, at the end of 2019, in China, a huge number of treatment recommendations for this entity have been published, not always supported by sufficient scientific evidence or with methodological rigor necessary. Thanks to the efforts of different groups of researchers, we currently have the results of clinical trials, and other types of studies, of higher quality. We consider it necessary to create a document that includes recommendations that collect this evidence regarding the diagnosis and treatment of COVID-19, but also aspects that other guidelines have not considered and that we consider essential in the management of critical patients with COVID-19. For this, a drafting committee has been created, made up of members of the SEMICYUC Working Groups more directly related to different specific aspects of the management of these patients.

[Post-COVID syndrome: A reflection and opinion paper]. / Síndrome post-COVID: Un documento de reflexión y opinión.

A high proportion of people who have suffered from COVID-19 report, after recovery from the acute phase of the disease, clinical manifestations, both subjective and objective, that continue beyond 3 weeks or even 3 months after the original clinical disease. There is still no agreed nomenclature to refer to this condition, but perhaps the most commonly used is post-COVID syndrome. The Scientific Committee on COVID of the Madrid College of Physicians (ICOMEM) has discussed this problem with a multidisciplinary approach in which internists, infectious disease specialists, psychiatrists, pneumologists, surgeons, geriatricians, pediatricians, microbiologists, family physicians and other specialists have participated, trying to gather the existing information and discussing it in the group. The clinical manifestations are very variable and range from simple fatigue to persistent fibrosing lung lesions with objective alterations of pulmonary function. Post-COVID syndrome seems to be particularly frequent and severe in adults who have required admission to Intensive Care Units and has a peculiar behavior in a very small group of children. The post-COVID syndrome, which undoubtedly exists, is at first sight not clearly distinguishable from clinical manifestations that which occur after other acute viral diseases and after prolonged stays in ICUs due to other diseases. Therefore, it offers excellent research opportunities to clarify its pathogenesis and possibly that of other related entities. It is possible that progressively there will be an increased demand for care among the millions of people who have suffered and overcome acute COVID for which the health authorities should design mechanisms for the agile management of care that will possibly require well-coordinated multidisciplinary groups. This paper, structured in questions on different aspects of the post-COVID syndrome, attempts to stage the current state of this problem.

[COVID-19 vaccination: the reality after clinical trials]. / Vacunación anti-COVID-19: La realidad tras los ensayos clínicos.

After the start of vaccination against SARS-CoV-2, enough clinical experience is already accumulating, in the real world and outside clinical trials, to resolve some of the questions that are still pending about this problem. The Scientific Committee on COVID-19 of the Madrid College of Physicians has discussed and reviewed some of these issues with a multidisciplinary approach. The following document is an attempt to answer some of these questions with the information available so far. This document is structured in questions on different aspects of the indications, efficacy and tolerance of anti-COVID-19 vaccination.

[Consensus document of the Spanish Society of Intensive and Critical Care Medicine and Coronary Units (SEMICYUC), the Spanish Society of Otorhinolaryngology and Head and Neck Surgery (SEORL-CCC) and the Spanish Society of Anesthesiology and Resuscitation (SEDAR) on tracheotomy in patients with COVID-19 infection]. / Documento de consenso de la Sociedad Española de Medicina Intensiva, Crítica y Unidades Coronarias (SEMICYUC), la Sociedad Española de Otorrinolaringología y Cirugía de Cabeza y Cuello (SEORL-CCC) y la Sociedad Española de Anestesiología y Reanimación (SEDAR) sobre la traqueotomía en pacientes con COVID-19.

The current COVID-19 pandemic has rendered up to 15% of patients under mechanical ventilation. Because the subsequent tracheotomy is a frequent procedure, the three societies mostly involved (SEMICYUC, SEDAR and SEORL-CCC) have setup a consensus paper that offers an overview about indications and contraindications of tracheotomy, be it by puncture or open, clarifying its respective advantages and enumerating the ideal conditions under which they should be performed, as well as the necessary steps. Regular and emergency situations are displayed together with the postoperative measures.