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- Late Gadolinium Enhancement in the Left Ventricular Wall Is Associated with Atrial Fibrillation in Patients with Hypertrophic CardiomyopathyPublication . Castelo, A; Aguiar Rosa, S; Fiarresga, A; Jalles, N; Vaz Ferreira, V; Garcia Brás, P; Branco, L; Oliveira, M; Cruz Ferreira, RPurpose: Atrial fibrillation (AF) is the most common arrhythmia in patients with hypertrophic cardiomyopathy (HCM). The aim of this study was to evaluate the relation between AF and left ventricular (LV) late gadolinium enhancement (LGE). Methods: 55 patients with HCM were retrospectively included. Patients were divided in HCM with AF and HCM without AF. Baseline clinical, echocardiographic and cardiovascular magnetic resonance (CMR) characteristics were collected and compared between groups. Results: In univariable analysis, the factors related to AF development were HCM risk score for sudden cardiac death (SCD) > 2.29% (p = 0.002), left atrium (LA) diameter > 42.5 mm (p = 0.014) and LGE in the mid anterior interventricular septum (IVS) (p = 0.021), basal inferior IVS (p = 0.012) and mid inferior IVS (p = 0.012). There were no differences in LV diastolic function and LA strain between groups. Independent predictors of AF were LA diameter (p = 0.022, HR 5.933) and LGE in mid inferior IVS (p = 0.45, HR 3.280). Combining LA diameter (> 42.5 mm or < 42.5 mm) and LGE in mid inferior IVS (present or absent) in a model with four groups showed a statistically significant difference between groups (p = 0.013 for the model). Conclusions: LGE in mid inferior IVS is an independent predictor for AF occurrence in patients with HCM. Combining both LGE in mid inferior IVS and enlarged LA improves prediction of AF and may be preferred for risk stratification.
- Prognosis after Myocardial Infarction - A Deep Look into Myocardial TissuePublication . Aguiar Rosa, S
- Early Versus Late Initiation of Direct Oral Anticoagulants in Post-Ischaemic Stroke Patients with Atrial FibrillatioN (ELAN): Protocol for an International, Multicentre, Randomised-Controlled, Two-Arm, Open, Assessor-Blinded TrialPublication . Fischer, U; Trelle, S; Branca, M; Salanti, G; Paciaroni, M; Ferrari, C; Abend, S; Beyeler, S; Strbian, D; Thomalla, G; Ntaios, G; Bonati, L; Michel, P; Nedeltchev, K; Gattringer, T; Sandset, E; Kelly, P; Lemmens, R; Koga, M; Sylaja, P; Aguiar de Sousa, D; Bornstein, N; Gdovinova, Z; Seiffge, D; Gralla, J; Horvath, T; Dawson, JRationale: Direct oral anticoagulants (DOAC) are highly effective in preventing ischaemic strokes in people with atrial fibrillation (AF). However, it is unclear how soon they should be started after acute ischaemic stroke (AIS). Early initiation may reduce early risk of recurrence but might increase the risk of haemorrhagic complications. Aim: To estimate the safety and efficacy of early initiation of DOACs compared to late guideline-based initiation in people with AIS related to AF. Methods and design: An international, multicentre, randomised (1:1) controlled, two-arm, open, assessor-blinded trial is being conducted. Early treatment is defined as DOAC initiation within 48 h of a minor or moderate stroke, or at day 6-7 following major stroke. Late treatment is defined as DOAC initiation after day 3-4 following minor stroke, after day 6-7 following moderate stroke and after day 12-14 following major stroke. Severity of stroke is defined according to imaging assessment of infarct size. Sample size: ELAN will randomise 2000 participants 1:1 to early versus late initiation of DOACs. This assumes a risk difference of 0.5% favouring the early arm, allowing an upper limit of the 95% confidence interval up to 1.5% based on the Miettinen & Nurminen formula. Outcomes: The primary outcome is a composite of symptomatic intracranial haemorrhage, major extracranial bleeding, recurrent ischaemic stroke, systemic embolism or vascular death at 30 ± 3 days after randomisation. Secondary outcomes include the individual components of the primary outcome at 30 ± 3 and 90 ± 7 days and functional status at 90 ± 7 days. Discussion: ELAN will estimate whether there is a clinically important difference in safety and efficacy outcomes following early anticoagulation with a DOAC compared to late guideline-based treatment in neuroimaging-selected people with an AIS due to AF.
- Remote versus In-Office Monitoring for Implantable Cardioverter Defibrillators: Results from a Randomized Pragmatic Controlled Study in PortugalPublication . Martins Oliveira, M; Fernandes, M; Reis, H; Primo, J; Sanfins, V; Silva, V; Silva Cunha, P; Silva, M; Nicola, P; PORTLink Study InvestigatorsIntroduction: Remote monitoring (RM) is a safe and effective alternative to in-office conventional follow-up. Objective: We aimed to evaluate patient satisfaction with RM and its impact on healthcare resources in a population with cardiac implantable electronic devices. Methods: Randomized, pragmatic, open-label controlled trial, with adult wearers of implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy with ICD (CRT-D), eligible for the CareLink® system. Patients newly implanted or with previous conventional follow-up were randomized to RM or conventional follow-up (control), and followed for 12 months, according to the centers' practice. The number of in-office visits and adverse events were compared between groups. Patient and healthcare professionals' satisfaction with RM were described. Results: Of the 134 randomized patients (69 RM; 65 control, aged 60±13 years), 80% were male, 23% employed, 72% ICD wearers and 54% newly implanted. Most patients (70%) reported travel costs less than 15€/visit, and 46% daily routine interference with in-office visits. Median physician/technician time with patient was 15 min/15 min, per in-office visit. Excluding baseline and final visits, control patients had more in-office visits in total: median 1 vs. 0, p<0.001. In 81% of the in-office visits, no clinical measures were taken. There were 10 adverse events, with no differences between groups. At the final visit, 95% of RM patients considered RM easy/very easy to use, and would all prefer to maintain RM and recommend it to others. All professionals found the CareLink website easy/very easy to use and were satisfied with transmission data. Conclusions: In a Portuguese population with ICD and CRT-D, RM safely reduced the burden of in-office visits, with high levels of satisfaction among patients and healthcare professionals.
- Scaling-Up Digital Follow-Up Care Services: Collaborative Development and Implementation of Remote Patient Monitoring Pilot Initiatives to Increase Access to Follow-Up CarePublication . Azevedo, S; Guede-Fernández, F; Hafe, F; Dias, P; Lopes, I; Cardoso, N; Coelho, P; Santos, J; Fragata, J; Vital, C; Semedo, H; Gualdino, A; Londral, ABackground: COVID-19 increased the demand for Remote Patient Monitoring (RPM) services as a rapid solution for safe patient follow-up in a lockdown context. Time and resource constraints resulted in unplanned scaled-up RPM pilot initiatives posing risks to the access and quality of care. Scalability and rapid implementation of RPM services require social change and active collaboration between stakeholders. Therefore, a participatory action research (PAR) approach is needed to support the collaborative development of the technological component while simultaneously implementing and evaluating the RPM service through critical action-reflection cycles. Objective: This study aims to demonstrate how PAR can be used to guide the scalability design of RPM pilot initiatives and the implementation of RPM-based follow-up services. Methods: Using a case study strategy, we described the PAR team's (nurses, physicians, developers, and researchers) activities within and across the four phases of the research process (problem definition, planning, action, and reflection). Team meetings were analyzed through content analysis and descriptive statistics. The PAR team selected ex-ante pilot initiatives to reflect upon features feedback and participatory level assessment. Pilot initiatives were investigated using semi-structured interviews transcribed and coded into themes following the principles of grounded theory and pilot meetings minutes and reports through content analysis. The PAR team used the MoSCoW prioritization method to define the set of features and descriptive statistics to reflect on the performance of the PAR approach. Results: The approach involved two action-reflection cycles. From the 15 features identified, the team classified 11 as must-haves in the scaled-up version. The participation was similar among researchers (52.9%), developers (47.5%), and physicians (46.7%), who focused on suggesting and planning actions. Nurses with the lowest participation (5.8%) focused on knowledge sharing and generation. The top three meeting outcomes were: improved research and development system (35.0%), socio-technical-economic constraints characterization (25.2%), and understanding of end-user technology utilization (22.0%). Conclusion: The scalability and implementation of RPM services must consider contextual factors, such as individuals' and organizations' interests and needs. The PAR approach supports simultaneously designing, developing, testing, and evaluating the RPM technological features, in a real-world context, with the participation of healthcare professionals, developers, and researchers.
- Functional Outcome of Endovascular Treatment in Patients With Acute Ischemic Stroke With Large Vessel Occlusion: Mothership Versus Drip-and-Ship Model in a Portuguese Urban RegionPublication . Ferreira Cristina, S; Fior, A; Alves, M; Papoila, AL; Paiva Nunes, AIntroduction Endovascular treatment (EVT) with mechanical thrombectomy and acute carotid stenting has become an integral part of the treatment of acute ischemic stroke with large vessel occlusion. Despite being included in the most recent stroke guidelines, only comprehensive centers can offer EVT and thus patients frequently need to be transferred from primary hospitals. We aimed to assess which pre-hospital model of care - direct admission to a comprehensive stroke center (mothership) or transfer to a comprehensive stroke center after the first admission to the nearest hospital (drip-and-ship) - had the most benefit in stroke patients in a Portuguese urban region. Methods We selected patients admitted to a comprehensive stroke center who underwent EVTs between January 2018 and December 2020, in Lisbon, Portugal. We used data from the Safe Implementation of Treatments in Stroke (SITS) International registry on stroke severity, previous modified Rankin Scale (mRS), time from symptom onset to the first admission, time from symptom onset to the procedure, and mRS three months post stroke. We defined an unfavorable outcome as having an mRS >2 at three months post stroke. For patients with previous mRS >2, an unfavorable outcome was defined as any increase in mRS at three months post stroke. Results We analyzed the data of 1154 patients, of which 407 were admitted through a mothership approach and 747 through a drip-and-ship approach. Both groups were similar regarding sociodemographic characteristics, stroke risk factors, previous disability, and stroke severity. Median onset-to-door time was higher (126 vs 110 minutes, p-value=0.002) but onset-to-procedure time was lower (199 vs 339 minutes, p-value<0.001) in the mothership group. The mothership group had a higher proportion of patients with mRS <3 at three months post stroke than the drip-and-ship group (41.3% vs 34.9%, p-value=0.035). Mortality was similar in both groups. A multivariate logistic regression model confirmed a lower probability of unfavorable outcomes with the mothership approach (OR = 0.677, 95% CI 0.514-0.892, p-value=0.006). Surprisingly, onset-to-procedure time did not have an impact on functional outcomes. Conclusion Our findings show that the mothership model results in better functional outcomes for patients with acute ischemic stroke with large vessel occlusion. Further studies are needed to better define patient selection for this strategy and the impact of a mothership model in comprehensive stroke centers.
- Fingolimod Treatment Modulates PPARγ and CD36 Gene Expression in Women with Multiple SclerosisPublication . Ferret-Sena, V; Capela, C; Macedo, A; Salgado, AV; Derudas, B; Staels, B; Sena, AFingolimod is an oral immunomodulatory drug used in the treatment of multiple sclerosis (MS) that may change lipid metabolism. Peroxisome proliferator-activated receptors (PPAR) are transcription factors that regulate lipoprotein metabolism and immune functions and have been implicated in the pathophysiology of MS. CD36 is a scavenger receptor whose transcription is PPAR regulated. The objective of this study was to evaluate whether fingolimod treatment modifies PPAR and CD36 gene expression as part of its action mechanisms. Serum lipoprotein profiles and PPAR and CD36 gene expression levels in peripheral leukocytes were analysed in 17 female MS patients before and at 6 and 12 months after fingolimod treatment initiation. Clinical data during the follow-up period of treatment were obtained. We found that fingolimod treatment increased HDL-Cholesterol and Apolipoprotein E levels and leukocyte PPARγ and CD36 gene expression. No correlations were found between lipid levels and variations in PPARγ and CD36 gene expression. PPARγ and CD36 variations were significantly correlated during therapy and in patients free of relapse and stable disease. Our results suggest that PPARγ and CD36-mediated processes may contribute to the mechanisms of action of fingolimod in MS. Further studies are required to explore the relation of the PPARγ/CD36 pathway to the clinical efficacy of the drug and its involvement in the pathogenesis of the disease.
- Periodontoid Pseudotumor in Tuberous Sclerosis Associated With Neck Diffuse LipomatosisPublication . Pinto, E; Veiga, M; Sagarribay, A; Conceição, CTuberous sclerosis (TS) is a genetic multisystem disorder associated with the development of benign tumors in many organs. Diffuse lipomatosis, which represents the overgrowth of fatty tissue in one part of the body, is a very rare finding reported in patients with tuberous sclerosis. We describe the case of a patient with diffuse lipomatosis in the right scapular, posterior cervical and perivertebral regions, associated with a space-occupying lesion adjacent to the odontoid process of C2 that appeared to be a pseudotumor, and discuss possible relation between these entities.
- Tumor Burden Score and Serum Alpha-fetoprotein Subclassify Intermediate-Stage Hepatocellular CarcinomaPublication . Lima, H; Endo, Y; Alaimo, L; Moazzam, Z; Munir, M; Shaikh, C; Resende, V; Guglielmi, A; Pinto Marques, H; Cauchy, F; Lam, V; Poultsides, G; Popescu, I; Alexandrescu, S; Martel, G; Hugh, T; Endo, I; Kitago, M; Shen, F; Pawlik, TBackground: Resection of Barcelona Clinic Liver Cancer (BCLC) intermediate-stage hepatocellular carcinoma (HCC) remains controversial. While not recommended by the BCLC algorithm, some patients may indeed benefit from hepatectomy. We sought to identify that subset of patients who might derive long-term survival benefit from resection. Methods: Intermediate-stage HCC patients who underwent curative-intent resection were identified from an international multi-institutional database. Factors associated with long-term prognosis were identified using multivariate analysis and a risk score was developed and assessed. Results: Among 194 patients, most individuals had two tumors (n = 123, 63.4%) with a median size of 6.0 cm (IQR, 4.0-8.4) for a median tumor burden score (TBS) of 6.5 (IQR, 5.0-9.1); median alpha-fetoprotein (AFP) was 23.9 ng/mL (IQR, 5.0-503.2), and median overall survival (OS) was 69 months (IAR, 60.7-77.3). Factors associated with OS included AFP (referent ≤ 20 ng/mL, > 20 ng/mL: HR 1.78 95%CI, 1.09-2.89) and TBS (referent TBS ≤ 8.0, TBS > 8.0: HR 1.72 95%CI, 1.07-2.75). While 71 (36.6%) patients had neither risk factor, 79 (40.7%) and 44 (22.7%) had 1 or 2, respectively. A simplified score stratified patients relative to recurrence-free survival (RFS) (0: 33.6% vs. 1: 18.0% vs. 2: 14.7%) (AUC 0.60) and recurrence time (i.e., < 6 months after surgery) (0: 21.3% vs. 1: 43.1% vs. 2: 68.6%) (AUC 0.69) (both p < 0.001). Of note, a higher score was also associated with incrementally worse 5-year OS (0: 68.1% vs. 1: 61.0% vs. 2: 29.9%) (AUC 0.62) (p < 0.001). Conclusion: Long-term OS and RFS outcomes varied considerably. Using a simple risk score, patients with low AFP and low TBS were identified as the subset of individuals most likely to benefit from resection.
- A Comprehensive Preoperative Predictive Score for Post-Hepatectomy Liver Failure After Hepatocellular Carcinoma Resection Based on Patient Comorbidities, Tumor Burden, and Liver Function: the CTF Score.Publication . Alaimo, Laura; Endo, Yutaka; Lima, Henrique A; Moazzam, Zorays; Shaikh, Chanza Fahim; Ruzzenente, Andrea; Guglielmi, Alfredo; Ratti, Francesca; Aldrighetti, Luca; Pinto Marques, Hugo; Cauchy, François; Lam, Vincent; Poultsides, George A; Popescu, Irinel; Alexandrescu, Sorin; Martel, Guillaume; Hugh, Tom; Endo, Itaru; Pawlik, Timothy MBackground: Post-hepatectomy liver failure (PHLF) is a dreaded complication following liver resection for hepatocellular carcinoma (HCC) with a high mortality rate. We sought to develop a score based on preoperative factors to predict PHLF. Methods: Patients who underwent resection for HCC between 2000 and 2020 were identified from an international multi-institutional database. Factors associated with PHLF were identified and used to develop a preoperative comorbidity-tumor burden-liver function (CTF) predictive score. Results: Among 1785 patients, 106 (5.9%) experienced PHLF. On multivariate analysis, several factors were associated with PHLF including high Charlson comorbidity index (CCI ≥ 5) (OR 2.80, 95%CI, 1.08-7.26), albumin-bilirubin (ALBI) (OR 1.99, 95%CI, 1.10-3.56), and tumor burden score (TBS) (OR 1.06, 95%CI, 1.02-1.11) (all p < 0.05). Using the beta-coefficients of these variables, a weighted predictive score was developed and made available online ( https://alaimolaura.shinyapps.io/PHLFriskCalculator/ ). The CTF score (c-index = 0.67) performed better than Child-Pugh score (CPS) (c-index = 0.53) or Barcelona clinic liver cancer system (BCLC) (c-index = 0.57) to predict PHLF. A high CTF score was also an independent adverse prognostic factor for survival (HR 1.61, 95%CI, 1.12-2.30) and recurrence (HR 1.36, 95%CI, 1.08-1.71) (both p = 0.01). Conclusion: Roughly 1 in 20 patients experienced PHLF following resection of HCC. Patient (i.e., CCI), tumor (i.e., TBS), and liver function (i.e., ALBI) factors were associated with risk of PHLF. These preoperative factors were incorporated into a novel CTF tool that was made available online, which outperformed other previously proposed tools.