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1.
JACC: Cardiovascular Interventions ; 15(4):S58-S59, 2022.
Article in English | EMBASE | ID: covidwho-1757494

ABSTRACT

Background: TAVR has emerged as a revolutionary treatment for patients with symptomatic and severe AS, irrespective of surgical-risk profile. Novel transcatheter heart valves (THV) with a lower profile, ease of use and expected longer durability are being developed to target younger and low-risk population. Myval is a 14Fr-balloon expandable THV with a skirt to minimize the occurrence of paravalvular leak (PVL), and has been recently approved for commercial use in Brazil. We sought to report our initial experience with this novel device. Methods: Single-center, single arm, open label prospective registry encompassing all consecutive patients referred to TAVR in our Institution between December 2020 and November 2021. Indication for TAVR was according to current international guidelines. Clinical and echocardiographic outcomes were defined accordingly to VARC-III criteria. Results: A total of 39 patients were enrolled so far. Mean age was 79.5 years, 42% were female and mean STS score was 4%. Pre-procedures mean gradient and aortic valve area were 53.3 mmHg and 0.7cm2, respectively. All procedures were performed under minimalist approach using percutaneous, femoral access. Two patients were treated for bicuspid aortic stenosis and four patients underwent a valve-in-valve procedure. Procedure success was achieved in 100% of the cases, and post-procedure echocardiogram revealed a mean residual gradient of 5 mmHg, with PVL greater than mild in a single case. Permanent pacemaker was required in only 2 patients, and mean hospital stay was 3.1 days. At 30-days, there were two deaths, one due to COVID in a patient who presented major access bleeding requiring prolonged hospital stay, and another one a cardiovascular death. Conclusion: In our initial experience with the Myval THV, valve performance and 30-day clinical results were encouraging. Low rates of complications were observed, comparable to the best last-generation THV. At the time of the meeting, three-month clinical and echocardiographic FU will be available.

2.
European Respiratory Journal ; 58:2, 2021.
Article in English | Web of Science | ID: covidwho-1708410
3.
Blood ; 138:4271, 2021.
Article in English | EMBASE | ID: covidwho-1582233

ABSTRACT

Introduction: The management of bleeding associated with direct oral anticoagulants (DOACs) is challenging and associated with high risk of morbidity/mortality despite the use of various reversal agents (Gomez-Outes et al. 2021). Routine tests cannot determine the level of DOAC anticoagulation and reversal agents carry potential prothrombotic complications (Garcia & Crowther 2021). We present an unusual case of a patient requiring emergent surgery with significant post-op bleeding due to profoundly delayed apixaban elimination. Case Description: A 63-year-old female presented to the emergency department (ED) with a 10-day history of worsening abdominal pain, distension, nausea and constipation. Her past medical history was notable for right sided heart failure, COVID-19 pneumonia requiring intubation, tissue mitral valve replacement, and post-op atrial fibrillation for which she was prescribed apixaban 5 mg BID. Her last dose of apixaban had been the night prior to ED presentation. In the ED, a CT of the abdomen revealed a 6 cm partially obstructing lesion involving the mid-sigmoid colon. Findings were consistent with evolving peritonitis and the patient underwent an emergent exploratory laparotomy, sigmoid resection, and end colostomy. Pre-op labs revealed WBC 12.4 x10 9/L, hemoglobin (hgb) 9.2 g/dL, and platelets 318 x10 9/L. Coagulation studies revealed a PT of 28 sec and INR of 2.5. The patient was given prothrombin complex concentrate (PCC) 25 units/kg and 1 mg of vitamin K prior to surgery. Postoperatively, the INR remained elevated, 2.0, and her hgb downtrended from 8.8 g/dL to 7.8 g/dL. On post-op day 1 the patient became hypotensive, with increased abdominal pain/distension, she also started bleeding from her ostomy. The INR was 2.4 and her hgb dropped to 6.0 g/dL. Red blood cells were given along with FFP, vitamin K and a 2 nd dose of PCC. The patient continued to decline, was transferred to the ICU where she was intubated and placed on CRRT. Hematology was consulted for the persistently prolonged PT/INR in the setting of bleeding despite multiple interventions to correct the INR. The patient's last dose of apixaban was ~48 h prior to ICU admission. A rapid heparin anti-Xa assay was performed and upon comparison with an in-house nomogram the result, 1.78 IU/mL, correlated to an apixaban dose between 180-200 ng/ml (average peak levels 2-4 h after administration are 171 ng/mL). This result was confirmed the following day by an apixaban anti-Xa assay, 190 ng/mL. A repeat test performed 11 h later showed a minimal decrease in apixaban indicating impaired clearance. Therapeutic plasma exchange (TPE) was considered for rapid removal of apixaban. We performed a 1.0 plasma volume exchange, using plasma as the replacement fluid, to remove apixaban. Pre and post TPE drug levels were 172 and 108 ng/mL, respectively. Due to an elevated apixaban level the next day, a second TPE was performed which dropped the level to 87 ng/mL. The patient began to improve clinically, with hgb stabilization ~10 g/dL. She was extubated and transferred to a medical floor for further management. Apixaban levels were still measurable, 16 ng/mL, on post op day 8, 11 days after her last dose. Discussion: Apixaban is a highly protein-bound drug (~90%) that is rapidly absorbed in the small intestine with a large Vd (21 L) and a t1/2 of ~12 h. Elimination primarily occurs through the fecal route (Byon et al. 2019). The factors impairing the elimination of the drug in this patient were the following: 1. Pre-op constipation resulting in 10 days without a bowel movement;2. Minimal bowel function post-op;and 3. Renal failure requiring CRRT after admission to the ICU. This case illustrates the profound effect intestinal obstruction/dysfunction can have on apixaban clearance. It also highlights the importance of laboratory test interpretation when managing coagulopathic patients. TPE is an effective way to remove drugs with high protein binding affinity (Mahmoud et al. 2021). TPE significantly reduced apixaban levels in our patient allowing for he ostasis and clinical improvement. To our knowledge, there are only two case reports regarding the effect of TPE on DOACs, one for apixaban, the other rivaroxaban (Hodulik et al. 2019). Conclusion: TPE can be considered as an option for rapid clearance of apixaban, or other highly protein bound anti-Xa inhibitors, in the setting of delayed elimination or when specific reversal agents are not safe/available. Disclosures: No relevant conflicts of interest to declare.

4.
Annals of Oncology ; 32:S1147, 2021.
Article in English | EMBASE | ID: covidwho-1432892

ABSTRACT

Background: Cancer patients (pts) have higher risk of severe COVID-19 infection. However, observations are based on non-comparative retrospective studies. Evidence regarding vaccination in cancer pts is limited, but there is enough evidence to support COVID-19 vaccination, even under active treatment. Data on humoral and cellular immune response to antiviral vaccination in cancer pts are scarce. In pts receiving immunosuppressive therapies (IST) like chemotherapy and targeted therapies, seroconversion/protection rates are expected to be lower than general population, but not in pts receiving immune checkpoint inhibitors (ICI). Serum antibodies against an infectious agent may be an immunity indicator. Methods: Prospective observational longitudinal study with the intent of evaluating the humoral response of cancer pts to COVID-19 vaccination. The study includes pts diagnosed in any stage, without or under active treatment, or survivors followed in Hospital Prof. Dr. Fernando Fonseca, in partnership with Instituto Gulbenkian de Ciência. Pts are divided into 4 arms, independently of the vaccine: A – IST;B – ICI;C –Hormone therapy (HT);D – Cancer survivors. Recruitment started in March 2021, expecting at least 50 pts per arm. IgG, IgA and IgM anti-SARS-CoV-2 antibodies ELISA determination in 9 timepoints: before 1st dose and at the 3rd, 6th, 12th, 15th, 24th, 36th, 48th and 60th weeks post 1st dose. Side effects’ questionnaire will be implemented after 1st and 2nd doses. Results: Recruitment is ongoing and a total of 202 pts were enrolled, of which 178 pts have 3-weeks post 1st dose evaluated: 101 in arm A: 11 in B: 31 in C;and 35 in D.The mean age is 61.6 years, with 53.4% females. Regarding vaccines, 55 pts were submitted to ChAdOx1-S/nCoC-19, 5 to Ad26.COV2.S, 89 to BNT162b2 and 12 to mRNA-1273 vaccines. At 3 weeks, 33/97 pts (34%) in arm A, 2/11 pts (18%) in B, 14/28 pts (50%) in C and 15/35 pts (43%) in D already generated anti-spike IgG. Most common side effects were local inflammatory reaction (47%), generalized muscle pain (17%), fatigue (11%), and chills (10%). Conclusions: Efficacy and safety profiles of vaccines against COVID-19 infection in cancer pts is still unknown.This study hopes to assess differences in immunization between pts’ treatment profiles and duration profiles and safety profiles. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.

5.
Sistemas & Gestao ; 16(2):187-195, 2021.
Article in Portuguese | Web of Science | ID: covidwho-1399722

ABSTRACT

Periods of interruption of activities, such as the COVID-19 pandemic, directly impact several economic sectors, the flow of goods, services, and information, as well as the supply chains. In this context, this paper aims to analyze the flow of information in the supply chain of pizza restaurants that operate in a certain city in the interior of the state of Sao Paulo. To this end, a multiple case study was conducted using a qualitative exploratory approach with questionnaires applied to four companies in this sector. The data collected was tabulated and showed that this supply chain suffered a negative impact, considering the comparison between the period before the pandemic and during the quarantine. These companies maintained their normal operations and supply;however, there was a need to readjust the prices of their products. Furthermore, cost and stock management needed to be reviewed, searching for new suppliers and products, agility in delivery, and more favorable payment terms. As a limitation of the research, we point out its qualitative nature and the low number of interviewees. Its value consists in contributing to the knowledge in terms of informational management in the foodservice supply chain in atypical situations such as the current global health crisis.

6.
Angiologia e Cirurgia Vascular ; 16(3):125-129, 2020.
Article in English | EMBASE | ID: covidwho-1106970

ABSTRACT

Introduction: Ever since the first positive case was identified on March 2nd in Lousada, a region close to the border of our catchment area, we reacted immediately by systematically repurposing our surgical wards. Objective: Describe the changed made by our Vascular Surgery Department from March 13 to May 14. Methods: We collected clinical, operative, and consultation volume data from March 13 to May 14 and we compared it with the historical averages. We also reviewed the documents related to the planification activity. Results: At the peak of the outbreak, weadopted a split-team policy and encouraged completeteam segregation to reduce the risk of intradepartmental cross-contamination. Non-ambulatory surgical volume decreased by 54.8% (from 31 cases to 14 cases), and the ambulatory surgical activity was cancelled. Our in-person consultation volume decreased 86.4%;73 consultations were completed by phone, in which the patient was never evaluated in-person. In the emergency room the main difference between the pre-pandemic to the pandemic was in the number of patients observed without vascular pathology (82 versus 28). Conclusions: The adaptation to C0VID-19 pandemic reduced significantly the surgical production of our Vascular Surgery Department.

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