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BACKGROUND: Evaluating outcomes of concurrent Cox-Maze procedures in elderly patients undergoing high-risk cardiac surgery. MEHODS: We retrospectively identified patients aged over 70 years with Atrial Fibrillation (AF) from 2011 to 2017 who had two or more other cardiac procedures. They were subdivided into two groups: 1. Cox-Maze IV AF ablation. 2. No-Surgical AF treatment. A propensity match score was used to generate a homogeneous cohort and to eliminate confounding variables. Heart rhythm was assessed from Holter reports or 12-lead ECG. Follow-up data was collected through telephone consultations and medical records. RESULTS: There were 239 patients. Median follow up was 61 months. 70 patients had Cox-Maze IV procedures (29.3%). Demographic, intra- and post-operative outcomes were similar between groups although duration of pre-operative AF was shorter in Cox-Maze group (p = 0.001). There was no significant 30-day mortality difference in propensity matched cohorts (n = 84. P = 0.078). Sinus rhythm at annual and latest follow-up was 84.9% and 80.0% respectively in Maze group - 160 patients (66.9%) were alive at long-term follow-up with good survival outcomes in Cox Maze group. There was a high proportion of patients in NYHA 1 status in Cox-Maze group. No differences observed in freedom from stroke (p = 0.80) or permanent pacemaker (p = 0.33) between the groups. CONCLUSIONS: Surgical ablation is beneficial in elderly patients undergoing high-risk surgery - promoting excellent long-term freedom from AF and symptomatic / prognostic benefits, without added risk. Therefore, surgical risk should not be reason to deny benefits of concomitant AF-ablation. CLINICAL TRIAL REGISTRATION: Not required.
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Fibrilação Atrial , Procedimentos Cirúrgicos Cardíacos , Humanos , Fibrilação Atrial/cirurgia , Masculino , Idoso , Feminino , Estudos Retrospectivos , Procedimentos Cirúrgicos Cardíacos/métodos , Idoso de 80 Anos ou mais , Ablação por Cateter/métodos , Procedimento do Labirinto , Resultado do Tratamento , Seguimentos , Fatores de RiscoRESUMO
Background/Objectives: In an era of growing evidence for transaortic valve implantation (TAVI), our research topic was the evaluation of how surgical aortic valve replacements (SAVRs) are performing in terms of short- and long-term outcomes in different risk categories. Methods: This was a single centre, prospective, and observational cohort study of consecutive patients with aortic valve stenosis, undergoing isolated aortic valve replacement using a biological or mechanical prosthesis, Freestyle™ (Medtronic, Minneapolis, MN, USA) graft, homograft, or Ross procedure. The participant data were collected by review of an internal database. The primary endpoints were all-cause operative mortality (in hospital and at 30 days) and late mortality at the follow-up date. The secondary composite endpoint was the incidence of postoperative complications. Results: 1501 patients underwent SAVR; the mean age was 67 years (SD: 12.6). The in-hospital mortality was 1% (n = 16). At a median follow-up of 60 months, the survival rate was 98.7%. The main predictors for mortality were operative urgency and cardiogenic shock. The overall incidence of PPM was 2.3% (n = 34). Patients who underwent Ross procedure were younger (mean age: 20 years (SD: 1.7)), had a lower incidence of postoperative complications, and were all alive at follow-up. Conclusions: SAVR shows an excellent survival rate and a low rate of postoperative complications despite an increasing surgical risk. Recent advancements in technology, like sutureless/rapid deployment prostheses and minimally invasive techniques, are shown to have favourable effects on outcomes.
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BACKGROUND: Nutrition exerts a fundamental role in the prevention of obesity (OB). The aim of this study was to assess the extent to which well recognized risk factors for early OB can be associated to overweight (OW) or OB under a standardized nutritional approach and surveillance in toddlers. METHODS: The eligible population was represented by 676 toddlers aged 24-36 months, assigned to 18 primary care pediatricians trained on nutritional issues who shared a standardized nutritional approach. Six-hundred-twenty-nine children (333 boys), mean age 27.8 ± 4.2 months were effectively included in this observational study. Parents received nutritional advice with particular emphasis to proteins and sugar composition supported by leaflets and reinforced at each visit. Body mass index was assessed at the age of 24-36 months. The following individual and family risk factors were considered: gestational age, birth weight, eutocic/caesarean delivery, milk feeding history, household smoking or antibiotics exposure, parents' weight, height and educational level. Prevalence of OW/OB was compared to a group of 742 toddlers (373 boys) under usual care. RESULTS: Under a standardized nutritional counselling, 28.1% toddlers were classified as OW/OB compared to 36.9% toddlers under usual care (p = 0.005). In unadjusted models, parental OW/OB was significantly associated to OW/OB in toddlers (p < 0.01), while high birth weight did not reach statistical significance (p = 0.07). In adjusted models, including all the explanatory variables studied, only paternal OW/OB vs. normal weight was significantly associated to OW/OB in toddlers (OR 2.035, 95% confidence interval 1.206-3.436). No protective effect of exclusive breast feeding during the first 6 months of age was demonstrated. CONCLUSIONS: Toddlers under a standardized nutrition counselling focused to limit protein and simple sugars, showed lower prevalence of OW/OB compared to usual care. Healthy promotion activities should take into account the influence of paternal BMI on the offspring adiposity.
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Obesidade Infantil , Humanos , Masculino , Feminino , Fatores de Risco , Obesidade Infantil/prevenção & controle , Obesidade Infantil/epidemiologia , Pré-Escolar , Índice de Massa Corporal , Aconselhamento , Prevalência , Itália/epidemiologiaRESUMO
Proximal humerus fractures account for about 5% of fragility fractures. These involve a significant burden of disability and a reduced quality of life. This study aims to compare functional results and surgical outcomes (closed reduction and internal fixation with the internal closure system of the proximal humerus) and the conservative management of proximal humerus fractures by 2-, 3-, 4-parts, in patients older than 55 years. Between January 2017 and April 2019, 65 patients with 2, 3 or 4-part fractures were retrospectively analyzed: 29 patients (5 males and 24 females) with an average age of 70.8 ± 9.9 years treated non-surgically (conservative group (CG)) and 36 patients (11 males and 25 females) with an average age of 66.2 ± 7.1 years treated surgically with plate fixation (operating group (OG)). Using different evaluation scores, we compared the OG and the CG. Through the DASH score we have seen how at 12 months there is a satisfactory result in patients with conservative treatment (p = 0.0019). Constant-Murley scale shows no difference between the two treatments (p = 0.2300). BARTHEL scale and SST score did not give statistically satisfactory results. Also, after one year of follow-up, patients treated with conservative therapy had a higher improvement in their Range of Motion (ROM) values than patients treated with surgical treatment. The results in terms of pain in NPRS at 3, 6, 12 months are better for conservative groups (p = 0,0000). Our findings suggest that conservative treatment in proximal humeral fractures, particularly in multi-fragmented fractures in patients over 55 years of age, designs an excellent alternative to the surgical option.
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Background and Objectives: Pulmonary hypertension (PH) secondary to left-sided valvular heart disease is associated with poor cardiac surgical outcome compared with patients without PH. Our objective was to investigate the prognostic factors of surgical outcome in patients with PH undergoing mitral valve (MV) and tricuspid valve (TV) surgery, in order to risk stratify their management. Materials and Methods: This is a retrospective observational study on patients with PH who underwent MV and TV surgery from 2011 to 2019. The primary outcome was all-cause mortality. The secondary outcomes were post-op respiratory and renal complications, length of intensive care unit stay and length of hospital stay. Results: Seventy-six patients were included in this study. The all-cause mortality was 13% (n = 10), with mean survival of 92.6 months. Among the patients, 9.2% (n = 7) had post-op renal failure requiring renal replacement therapy and 6.6% (n = 5) had post-op respiratory failure requiring intubation. Univariate analysis demonstrated that pre-operative left ventricular ejection fraction (LVEF), peak systolic tissue velocity at the tricuspid annulus (S') and etiology of MV disease were associated with respiratory and renal failure. Tricuspid annular plane systolic excursion (TAPSE) was associated with respiratory failure only. S', type of operation, LVEF, urgency of surgery, and etiology of MV disease were found to be predictive of mortality. After excluding redo mitral surgery, all statistically significant findings remain unchanged, with the addition of right ventricular (RV) size being associated with respiratory failure. In the subgroup analysis of routine cases (n = 56), patients with primary mitral regurgitation who underwent mitral valve repair had better survival outcome. Conclusions: Urgency of surgery, etiology of MV disease, type of operation (replacement or repair), S' and pre-op LVEF are prognostic indicators in this small cohort of patients with PH undergoing MV and TV surgery. A larger prospective study is warranted to validate our findings.
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Cardiopatias , Hipertensão Pulmonar , Valva Mitral , Valva Tricúspide , Humanos , Hipertensão Pulmonar/complicações , Valva Tricúspide/cirurgia , Valva Mitral/cirurgia , Cardiopatias/cirurgia , Estudos Retrospectivos , Tempo de Internação , Mortalidade , Função Ventricular Esquerda , Resultado do Tratamento , Ecocardiografia , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Análise de Sobrevida , Insuficiência Renal/complicações , Doenças Respiratórias/complicaçõesRESUMO
Background: ß-thalassemia is a hereditary blood disorder resulting in ineffective erythropoiesis and anemia. Management of anemia with regular blood transfusions is associated with complications including iron overload. Here, we report long-term safety and efficacy results of the first clinical study of luspatercept in ß-thalassemia, initiated in 2013, enrolling adults with both nontransfusion-dependent (NTD) and transfusion-dependent (TD) ß-thalassemia. Objectives: The objective was to report long-term safety data, for up to 5 years of treatment, for 64 patients with TD or NTD ß-thalassemia, and long-term efficacy data for a subset of 63 patients with ß-thalassemia who received high-dose luspatercept (0.6-1.25 mg/kg): 31 NTD and 32 TD patients. Design: The study was a phase 2, noncontrolled, open-label trial comprising a dose-finding base phase and a 5-year extension phase. Methods: Endpoints include safety; erythroid response over a continuous 12-week period [NTD: hemoglobin increase from baseline ⩾1.0 or ⩾1.5 g/dl; TD: red blood cell (RBC) transfusion burden reduction, ⩾20%, ⩾33%, or ⩾50%]; and changes in biomarkers of ineffective erythropoiesis, iron metabolism parameters, Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) scores, and 6-min walking distance. Results: Median duration of luspatercept exposure for NTD and TD patients was 910 days (range, 40-1850) and 433 days (range, 21-1790), respectively. Seventeen of 31 (54.8%) NTD patients achieved a mean hemoglobin increase of ⩾1.5 g/dl and 19 of 32 (59.4%) TD patients achieved ⩾50% reduction in RBC transfusion burden, during any continuous 12-week period. Median cumulative duration of response was 1126 days (range, 127-1790) for NTD patients and 909 days (range, 87-1734) for TD patients. The most common treatment-related adverse events of any grade were bone pain, headache, and myalgia. Conclusion: Long-term assessment of patients with ß-thalassemia showed luspatercept was associated with sustained increases in hemoglobin levels in NTD patients and sustained transfusion burden reductions in TD patients. Trial registration: (ClinicalTrials.gov Identifiers: NCT01749540 and NCT02268409). Plain Language Summary: Long-term safety and erythroid response with luspatercept treatment in patients with ß-thalassemia Background: ß-thalassemia is a genetic blood disorder caused by mutations in the ß-globin gene, which encodes one of the proteins that comprise hemoglobin, a key constituent of red blood cells. Patients with ß-thalassemia experience anemia, the main treatment for which is blood transfusions. Long-term repeated blood transfusions lower patients' quality of life, use hospital resources, and the resulting accumulation of excess iron can cause organ failure and decrease life expectancy. The severity of the anemia experienced by patients with ß-thalassemia varies; patients with transfusion-dependent ß-thalassemia require regular blood transfusions, compared with those with nontransfusion-dependent ß-thalassemia who require infrequent transfusions, or even none at all, to manage their symptoms. Luspatercept (Reblozyl®) is an agent that stimulates the production of red blood cells and is used to treat anemia caused by ß-thalassemia. However, the long-term effects of luspatercept treatment on patients with ß-thalassemia are not known.Objective: In this study, we report the long-term safety of luspatercept in 64 adult patients with either transfusion-dependent or nontransfusion-dependent ß-thalassemia, and the long-term efficacy of high-dose luspatercept (0.6-1.25 mg/kg) in a subset of 63 patients.Results: The average time period that patients were treated with luspatercept was 910 days for nontransfusion-dependent ß-thalassemia and 433 days for transfusion-dependent ß-thalassemia. We report that in patients with nontransfusion-dependent ß-thalassemia, luspatercept treatment was associated with sustained increases, just over 3 years, in hemoglobin levels. Likewise, in transfusion-dependent ß-thalassemia, luspatercept treatment was associated with a sustained reduction, 2.5 years, in the amount of blood transfusion required to manage their anemia. Long-term treatment with luspatercept was not associated with any new side effects compared with previous short-term treatment studies. The most common side effects were headache (27 patients), bone pain (20 patients), and muscle pain (14 patients) with more than 90% of these patients experiencing these side effects as mild severity.Conclusion: The results of this study show that in patients with either transfusion-dependent or nontransfusion-dependent ß-thalassemia, luspatercept provides lasting reduction in anemia with mostly mild and predictable side effects.
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Background: Proximal humerus fractures (PHFs) are one of the most frequent fractures in the elderly and are the third most fractures after those of the hip and wrist. PHFs are assessed clinically through conventionally standard imaging (X-ray and computed tomography (CT) scans). The present study aims to conduct the diagnostic evaluation and therapeutic efficacy of the 3D-printed models (3DPMs) for the PHFs, compared with the standard imaging. Objectives: In terms of fracture classification and surgical indication, PHFs have poor interobserver agreement between orthopedic surgeons using traditional imaging such as X-rays and CT scan. Our objective is to compare interobserver reliability in diagnostic evaluation of PHFs using 3DPMs compared to traditional imaging. Methods: The inclusion criteria were elders aged >65 years, fracture classification AO/OTA 11 B and 11 C, and no pathological fractures or polytrauma. In addition, 9 PHFs were assessed by 6 evaluators through a questionnaire and double-blinded administered for each imaging (X-ray and CT scan) and 3DPMs for each fracture. The questionnaire for each method regarded Neer classification, Hertel classification, treatment indication (IT), and surgical technique (ST). Interobserver reliability was calculated through the intraclass correlation coefficient (ICC). Results: Nine patients with PHF were included in the study (66% female). The Neer and Hertel classifications between imaging types had similar ICC values between raters with no statistical differences. IT reliability using CT scan and 3DPMs (ICC = 1; (p=0.116)) assessed better agreement compared with X-rays IT. The ST reliability using 3DPMs (ICC = 0.755; p=0.002) was statistically superior to traditional imaging (ST-RX ICC = -0.004 (p=0.454); ST-CT ICC = 0.429 (p=0.116)). Conclusion: Classification systems like Neer and Hertel offer poor reliability between operators. The 3DPMs for evaluating diagnostics are comparable to CT images but superior to the surgical technique agreement. The application of 3DPMs is effective for preoperative fracture planning and the modeling of patient-specific hardware.
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This report describes the case of a 64-year-old Caucasian woman presenting with hypertransaminasemia during treatment with teriparatide for postmenopausal osteoporosis. The patient was also receiving food supplements containing red yeast rice (RYR) to lower her cholesterol levels. RYR has been reported to cause hepatoxicity because it contains monacolin K. According to the results of a causality assessment, carried out via several probability scales, teriparatide was defined as a 'possible' cause of the adverse drug reaction (ADR). Following progressive normalisation of the levels of transaminases after the teriparatide was discontinued, we therefore postulated that teriparatide was the main cause of the ADR. In addition to this, based on a literature review, we considered RYR as a concomitant agent in the aetiology of the ADR. Further post-marketing surveillance studies on teriparatide seem to be necessary.
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Teriparatida , Transaminases , Suplementos Nutricionais/análise , Feminino , Humanos , Lovastatina/uso terapêutico , Pessoa de Meia-Idade , Teriparatida/efeitos adversosRESUMO
AIM: To determine the safety and feasibility of an early (12 h) waking and extubation protocol for out-of-hospital cardiac arrest (OHCA) patients receiving targeted temperature management (TTM). METHODS: This was a single-centre, prospective, non-randomised, observational, safety and feasibility pilot study which included successfully resuscitated OHCA patients, of presumed cardiac cause. Inclusion criteria were: OHCA patients aged over 18 years with a return of spontaneous circulation, who were going to receive TTM33 (TTM at 33 °C for 24 h and prevention of hyperthermia for 72 h) as part of their post cardiac arrest care. Clinical stability was measured against physiological and neurological parameters as well as clinical assessment. RESULTS: 50 consecutive patients were included (median age 65.5 years, 82% male) in the study. Four (8%) patients died within the first twelve hours and were excluded from the final cohort (n = 46). Twenty-three patients (46%) were considered clinically stable and suitable for early waking based on the intention to treat analysis; 12 patients were extubated early based on a variety of clinical factors (21.4 ± 8.6 h) whilst continuing to receive TTM33 with a mean core temperature of 34.2 °C when extubated. Of these, five patients were discharged from the intensive care unit (ICU) <48 h after admission with a mean ICU length of stay 1.8 ± 0.4 days. Twenty-eight patients (56%) were discharged from the ICU with a modified Rankin Score of 0-2. The overall intra-hospital mortality was 50% (n = 25). CONCLUSIONS: It is safe and feasible to wake selected comatose OHCA patients at 12 h, allowing for earlier positive neuro-prognostication and reduced ICU stay.
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Hipotermia Induzida , Parada Cardíaca Extra-Hospitalar , Adulto , Idoso , Estudos de Viabilidade , Feminino , Humanos , Hipotermia Induzida/efeitos adversos , Hipotermia Induzida/métodos , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Estudos ProspectivosRESUMO
BACKGROUND AND AIM: Proximal humeral fracture is one of the most common osteoporotic fractures in elderly people. The proper treatment choice is controversial. Open reduction and internal fixation (ORIF) with plate and screws is currently the most common treatment for the majority of displaced proximal humeral fractures. The aim of this systematic review is to investigate the surgical treatment outcomes of PHFs, focusing on main used devices and surgical approaches. METHODS: From the earliest record up to 21 July 2020, two independent authors conducted a systematic review of two medical electronic database (PubMed and Science Direct). To achieve the maximum sensitivity of the search strategy, the following terms were combined: "(proximal NOT shaft NOT distal) AND humeral AND fracture AND (plate OR locking plate OR osteosynthesis NOT nail NOT arthroplasty)" as either key words or MeSH terms. The risk of bias of the included studies was assessed, agreeing to the Cochrane Handbook guidelines. RESULTS: Thirty-four articles were initially noticed after the term string research in the two electronic databases. Finally, after full-text reading and analyzing the reference list, 8 studies were selected. The mean age recorded was 69.5 years (Range 67-72). All the studies included two-, three-, four-fragments fracture. Seven studies investigated PHILOS (Synthes, Bettlach, Switzerland) implants results, while one investigated CFR-PEEK plate (PEEK Power Humeral Fracture Plate; Arthrex, Naples, Florida, USA) outcomes or other plates. Deltopectoral and Transdeltoid approaches were the more common used. CONCLUSIONS: Both deltopectoral and transdeltoid approaches are valid approach in plating after proximal humerus fractures, for these reasons, the surgeon experience is crucial in the choice. The more valid implant is still unclear. The develop of prospective randomized comparative studies is strongly encourages.
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Fraturas do Úmero , Fraturas do Ombro , Adulto , Idoso , Placas Ósseas , Fixação Interna de Fraturas , Humanos , Fraturas do Úmero/cirurgia , Úmero , Estudos Prospectivos , Fraturas do Ombro/cirurgia , Resultado do TratamentoRESUMO
An aneurysm of a single sinus of Valsalva is rare. It is usually asymptomatic and rarely discovered, unless it compresses the adjacent cardiac structures, or it presents in association with other pathology. We herein describe a case of a male, with known ischemic heart disease, collapsing after sudden back pain. A computed tomography scan demonstrated an aneurysm of the right sinus of Valsalva. The surgical repair aimed to exclude the aneurysm, preserving and reconstructing the aortic root.
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Papillary fibroelastomas have a range of clinical presentations. The surgical removal of these tumors should always be considered as best alternative to a conservative approach.
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Colonoscopy is generally considered a safe procedure, with a low rate of complications. Although rare, the migration of the colonoscope may represent life-threatening events, requiring emergency treatment. We, herein, describe the case of an elective colonoscopy complicated by an irretrievable colonoscope that migrated, through a previous traumatic diaphragmatic hernia, in the chest cavity. This hernia was likely a chronic complication of a previous abdominal trauma. Several attempts to retrieve the scope were unsuccessful. After further investigations and collegial discussion, a left thoracotomy was performed, with the aim to retrieve the colonoscope and to reduce the hernia.
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Colonoscópios/efeitos adversos , Colonoscopia/efeitos adversos , Corpos Estranhos/cirurgia , Migração de Corpo Estranho/cirurgia , Cavidade Torácica , Toracotomia/métodos , Traumatismos Abdominais/complicações , Idoso , Hérnia Diafragmática/etiologia , Humanos , MasculinoRESUMO
Injury or distortion of the circumflex coronary artery can occur during mitral valve surgery, due to its proximity to the mitral valve annulus. We present the case of a 72-year-old male patient with symptomatic mitral regurgitation, who underwent minimally invasive mitral valve surgery. The initial reparative gesture was complicated by intraoperative infarct due to a distortion of the circumflex artery (CX) caused by the rigidity of the ring used; the mainstay of the treatment was the removal of the previous device implanted in favor of a flexible one with restitutio ad integrum of the CX patency.
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Vasos Coronários/lesões , Vasos Coronários/cirurgia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Anuloplastia da Valva Mitral/efeitos adversos , Anuloplastia da Valva Mitral/métodos , Insuficiência da Valva Mitral/cirurgia , Valva Mitral/cirurgia , Idoso , Angiografia por Tomografia Computadorizada , Ponte de Artéria Coronária , Vasos Coronários/diagnóstico por imagem , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Masculino , Procedimentos Cirúrgicos Minimamente Invasivos/efeitos adversos , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Tomografia Computadorizada por Raios X , Resultado do TratamentoRESUMO
Traumatic tricuspid regurgitation (TR) is a rare cause of acute right ventricular dysfunction. The surgical technique could be complex and the reparative gesture has a lower success rate when compared with functional TR. We present the case of a 26-year-old male patient with traumatic TR who underwent tricuspid valve repair, with an initial satisfactory result. Later, the onset of acute severe residual TR was observed and the valve needed to be replaced. Surgery is the mainstay of treatment for traumatic TR, either in the form of repair or replacement. It requires an early diagnosis and concomitant treatment of injuries.
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Anuloplastia da Valva Cardíaca/métodos , Implante de Prótese de Valva Cardíaca/métodos , Insuficiência da Valva Tricúspide/etiologia , Insuficiência da Valva Tricúspide/cirurgia , Valva Tricúspide/cirurgia , Ferimentos e Lesões/complicações , Acidentes por Quedas , Adulto , Diagnóstico Precoce , Humanos , Masculino , Resultado do Tratamento , Insuficiência da Valva Tricúspide/diagnósticoRESUMO
OBJECTIVE: To provide, with the use of preoperative coronary computed tomography angiography, an in vivo anatomical characterization of the relationship between the circumflex artery and mitral valve annulus to identify different risk classes and to increase the surgical awareness of those anatomical relations. METHODS: Ninety-five (mean age: 64.2 ± 11.7) consecutive patients, initially referred for elective minimally invasive mitral valve surgery, underwent preoperative coronary computed tomography angiography. The distance between the circumflex artery and mitral annulus was assessed using 6 points designed on the posterior mitral annulus, starting from the anterolateral to the posteromedial commissure; this design created an ideal 5-zone system. High-risk anatomy was defined as a distance less than 3 mm between the circumflex artery and the mitral valve annulus. RESULTS: The shortest distance between the circumflex artery and mitral valve annulus was observed at the area between the anterolateral commissure and the midpoint of P1 scallop, so-called zone 1 (5.49 ± 3.13 mm), whereas the longest distance occurred at zone 5 (12.03 ± 4.93). Twenty-four patients (25%) were identified with high-risk anatomy (mean distance 1.94 ± 0.8 mm). Left dominant and co-dominant hearts demonstrated a shorter circumflex artery-mitral valve annulus distance at all the zones. At multinomial logistic regression, the pattern of coronary dominance and the size of the circumflex artery were independent factors for high-risk anatomy. CONCLUSIONS: Coronary computed tomography angiography is a useful investigation to identify patients at risk of circumflex artery flow disturbance; for high-risk anatomy, this knowledge may enhance a safer operative technique.
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ß-thalassemia is a hereditary disorder with limited approved treatment options; patients experience anemia and its complications, including iron overload. The study aim was to determine whether luspatercept could improve anemia and disease complications in patients with ß-thalassemia. This open-label, nonrandomized, uncontrolled study consisted of a 24-week dose-finding and expansion stage (initial stage) and a 5-year extension stage, currently ongoing. Sixty-four patients were enrolled; 33 were non-transfusion dependent (mean hemoglobin, <10.0 g/dL; <4 red blood cell [RBC] units transfused per 8 weeks), and 31 were transfusion dependent (≥4 RBC units per 8 weeks). Patients received 0.2 to 1.25 mg/kg luspatercept subcutaneously every 21 days for ≥5 cycles (dose-finding stage) and 0.8 to 1.25 mg/kg (expansion cohort and 5-year extension). The primary end point was erythroid response, defined as hemoglobin increase of ≥1.5 g/dL from baseline for ≥14 consecutive days (without RBC transfusions) for non-transfusion-dependent patients or RBC transfusion burden reduction ≥20% over a 12-week period vs the 12 weeks before treatment for transfusion-dependent patients. Eighteen non-transfusion-dependent patients (58%) receiving higher dose levels of luspatercept (0.6-1.25 mg/kg) achieved mean hemoglobin increase ≥1.5 g/dL over ≥14 days vs baseline. Twenty-six (81%) transfusion-dependent patients achieved ≥20% reduction in RBC transfusion burden. The most common grade 1 to 2 adverse events were bone pain, headache, and myalgia. As of the cutoff, 33 patients remain on study. In this study, a high percentage of ß-thalassemia patients receiving luspatercept had hemoglobin or transfusion burden improvements. These findings support a randomized clinical trial to assess efficacy and safety. This study was registered at www.clinicaltrials.gov as #NCT01749540 and #NCT02268409.
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Ativinas/uso terapêutico , Transfusão de Eritrócitos/estatística & dados numéricos , Hemoglobinas/análise , Fragmentos Fc das Imunoglobulinas/uso terapêutico , Proteínas Recombinantes de Fusão/uso terapêutico , Talassemia beta/tratamento farmacológico , Receptores de Activinas Tipo II , Adulto , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Adulto JovemRESUMO
Mild therapeutic hypothermia (MTH 33°C) post out-of-hospital cardiac arrest (OHCA) is widely accepted as standard of care. However, uncertainty remains around the dose and therapy duration. OHCA patients are usually kept sedated±paralyzed and ventilated for the first 24-36 hours, which allows for targeted temperature management, but makes neurological prognostication challenging. The aim of this study is to investigate the feasibility and safety of assessing the unconscious OHCA patient after 12 hours for early waking/extubation while continuing to provide MTH for 24 hours, and fever prevention for 72 hours by using an intravenous temperature management (IVTM) system and established conscious MTH anti-shiver regimens. This is a single-center, prospective, non-randomized observational study that will compare the results of early awakening (at 12 hours) with historical controls. A total of 50 consecutive unconscious survivors of OHCA, treated with MTH, who meet the Therapeutic Hypothermia and eArly Waking (THAW) inclusion criteria will be enrolled. The patient will receive MTH by using IVTM. After 12 hours of MTH, patients will be assessed by using strict clinical criteria to determine suitability for early waking and extubation. Once awake and extubated, MTH will continue for 24 hours with skin counter-warming and anti-shiver regimen followed fever prevention up to 72 hours. All patients will have serial electroencephalogram (EEG), somatic sensory potential, and neuro-biomarkers performed on admission to intensive care unit, 6 and 12 hours, then every 24 hours until 72 hours. The study has been approved by the National Research Ethics Service, Health Research Authority.
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Hipotermia Induzida/métodos , Exame Neurológico , Parada Cardíaca Extra-Hospitalar/terapia , Estudos de Viabilidade , Humanos , Estudos ProspectivosRESUMO
Aims: Cardiovascular magnetic resonance (CMR) has dramatically changed the clinical practice in thalassemia major (TM), lowering cardiac complications. We prospectively reassessed the predictive value of CMR parameters for heart failure (HF) and arrhythmias in TM. Methods and results: We considered 481 white TM patients (29.48 ± 8.93 years, 263 females) enrolled in the Myocardial Iron Overload in Thalassemia (MIOT) network. Myocardial and liver iron overload were measured by T2* multiecho technique. Atrial dimensions and biventricular function were quantified by cine images. Late gadolinium enhancement images were acquired to detect myocardial fibrosis. Mean follow-up was 57.91 ± 18.23 months. After the first CMR scan 69.6% of the patients changed chelation regimen. We recorded 18 episodes of HF. In the multivariate analysis the independent predictive factors were myocardial fibrosis (HR = 10.94, 95% CI = 3.28-36.43, P < 0.0001), homogeneous MIO (compared with no MIO) (HR = 5.56, 95% CI = 1.37-22.51, P = 0.016), ventricular dysfunction (HR = 4.33, 95% CI = 1.39-13.43, P = 0.011). Arrhythmias occurred in 16 patients. Among the CMR parameters only the atrial dilation was identified as univariate prognosticator (HR = 4.26 95% CI=1.54-11.75, P = 0.005). Conclusions: CMR guided the change of chelation therapy in nearly 70% of patients, leading to a lower risk of iron-mediated HF and of arrhythmias than previously reported. Homogeneous MIO remained a risk factor for HF but also myocardial fibrosis and ventricular dysfunction identified patients at high risk. Arrhythmias were independent of MIO but increased with atrial dilatation. CMR by a multi-parametric approach dramatically improves cardiac outcomes and provides prognostic information beyond cardiac iron estimation.