Head and Neck Tumours - Resection and Primary Reconstruction

INTRODUCTION: Reconstruction after extirpation of Head and Neck cancers continue to be a surgical challenge. Majority of patients are debilitated and present with locally advanced disease. Poor long term survival and the need for adjuvant Radiotherapy demand that in most cases the reconstruction should be immediate and single stage, should allow a rapid restoration of function and should have a low morbidity. Edgerton introduced the concept of immediate reconstruction after resection of Head & Neck Cancers in 1951. We have reached an era in which we must deal with one stage, recurrence preventing operations and primary reconstructions with respect to surgeons pride but also considering justifiable economic concerns. There are now individuals and teams with enormous experience in Head and Neck tumour surgery. Improvements in imaging techniques have resulted in better delineation of tumour extent, better selection of approach and more precise planning of reconstruction. Imaging modalities as axial and coronal two dimensional CT, Interactive three dimensional CT, MR imaging, Angiography, Spiral CT and software packages enabling interactive CT and MRI manipulation allow mock resections to be performed on the screen. If ablative surgery has been carried out elsewhere, the ability to use mirror imaging to superimpose the normal side as the deformed side provides real insight into the volume of hard and soft tissue needed to reconstruct the defect. AIM OF STUDY: The main objectives of this clinical study are 1. To discuss the age and sex incidence in our study. 2. To discuss the anatomical site of tumour. 3. To discuss the pathology and grading of tumour. 4. To discuss the type of resection done. 5. To discuss the previous modalities of treatment as chemotherapy and radiotherapy. 6. To study the type of reconstructions done. 7. To study the post operative complications. 8. To discuss the post operative management. MATERIALS AND METHODS: MATERIALS: This work includes the study of 50 patients with a diagnosis of tumour of the head and neck region who were subjected to surgical extirpation of the disease either curative or palliative and the defect was reconstructed primarily. The patients who were admitted in Government Rajaji Hospital, Madurai Medical College , Madurai to Plastic Surgery, Surgical Oncology and General Surgery wards were studied between August 2003 – October 2005. METHODS: The methods include obtaining information from patients, thorough clinical examination and doing necessary investigations for management. All informations were entered in a proforma specially designed for this study. METHODOLOGY: The patient’s name,age, sex, symptoms and its duration were obtained. Personal history like smoking, alcohol consumption and diet pattern were obtained. Patients were examined in detail for secondaries and operability. Basic investigations like blood Hb estimation, urine examination, blood sugar and renal parameters like urea, creatinine were done. Serum protein levels were assessed. X ray chest and ECG were taken. The extent of the disease is noted by X ray of the local region, CT scan and MRI as indicated. Tissue diagnosis and its grading were assessed. Cardiac status was examined by specialist of our institution. Diabetic patients were treated on Diabetologist opinion. Based on the above investigations, patients were assessed for general anaesthesia and managed surgically. Intraoperative, post operative complications were noted and managed accordingly. All the patients were reviewed in our OP department. OBSERVATIONS: Total of 1508 cases of cancer were admitted in our hospital. Out of this 151 cases were head and neck malignancies. 50 of this cases were taken up for study. All cases were in the age group from 6 – 80 years. 48 % cases were male and 52 % were female in our study. In this study, 4 % of cases had lesions over scalp, 2 % in forehead, 14 % in eyelid, 2 % in the eye, 12 % in the nose, 10 % in the lip, 12 % in the oral cavity, 38 % in the cheek, 2 % in the submandibular region and 4 % in the neck region. Most of the lesions were in the cheek. In this study 52 % were squamous cell carcinoma, 28 % were basal cell carcinoma, 6% were meibomian carcinoma, 4 % were haemangioma, 4% were neurofibroma, 2 % were papilloma, 2% were adamantinoma , 2 % were retinoblastoma and 2% were Rhabdomyo sarcoma. In this study, 82 % were well differentiated and 18 % were poorly differentiated tumours. In this study, 56 % of cases were cured and 44 % were given palliative treatment. Out of 50 cases 34 % had cardiology opinion before surgery. Patients on antihypertensive / anti anginal drugs were examined for cardiac status by clinical outlook, ECG and ECHO. 4 % had diabetologist opinion, 12 % had opthal opinion, 4 % had neurosurgery opinion, 2% had cardiothoracic, 2 % had radiotherapist opinion and 2% had ENT opinion. In this study, 16 % had orocutaneous fistula , 8 % had flap dehiscence at business end, 8 % had wound infection, 4 % had bone nonunion and 2 % had delayed healing as immediate complications. 68 % had no complications. As late complications, 10 % had orocutaneous fistula, 2 % had corneal adhesions, 2% had loss of vision, 2 % had flap returned, 2 % wound dehiscence and 82 % had no complications. CONCLUSION: Collaboration and Communication of multidisciplinary teams have had a profound effect in the treatment of head and neck cancers. The ability to surgically extirpate large tumours without fear of compromising the surgical margins and to provide adequate and reliable reconstruction methods improve local and regional control of disease. The concept of maintaining quality of life has become particularly important in overall care and treatment of cancer patients. Thus even patients with a very limited life expectancy should be offered resection and reconstruction, if it is expected that their quality of remaining life would be enhanced significantly. Teams of Oncologic and Reconstructive surgeons provide state of art judgement and skill for patients, even with advanced head and neck malignancies. Above all it upholds the surgeons pride and success in human care

Wu lun shu : [62 juan] / [Ming Xuanzong chi zhuan] 五倫書 : [62卷] / [明宣宗敕撰]

Contents: [v.1] juan zhi san 卷之三 -- [v.2] juan zhi si 卷之三四 -- [v.3] juan zhi wu 卷之五 -- [v.4] juan zhi liu 卷之六 -- [v.5] juan zhi qi 卷之七 -- [v.6] juan zhi ba 卷之八 -- [v.7] juan zhi shi san 卷之十三 -- [v.8] juan zhi shi liu 卷之十六 -- [v.9] juan zhi shi ba 卷之十八 -- [v.10] juan zhi er shi yi 卷之二十一 - [v.11] juan zhi er shi er 卷之二十二 -- [v.12] juan zhi san shi san 卷之三十三 -- [v.13] juan zhi san shi qi 卷之三十七 -- [v.14] juan zhi san shi ba 卷之三十八 -- [v.15] juan zhi san shi jiu 卷之三十九

Influence of endpoint definitions on the effect of empagliflozin on major renal outcomes in the EMPEROR-Preserved trial.

RESEARCH LETTER - No abstract available

Concentration-dependent clinical and prognostic importance of high-sensitivity cardiac troponin T in heart failure and a reduced ejection fraction and the influence of empagliflozin: the EMPEROR-Reduced trial.

AIMS: Circulating troponin is an important measure of risk in patients with heart failure, but it has not been used to determine if disease severity influences the responses to drug treatments in randomized controlled trials. METHODS AND RESULTS: In the EMPEROR-Reduced trial, patients with class II-IV heart failure and a reduced ejection fraction were randomly assigned to placebo or empagliflozin 10 mg daily and followed for the occurrence of serious heart failure and renal events. High-sensitivity cardiac troponin T (hs-cTnT) was measured in 3636 patients (>97%) at baseline, and patients were divided into four groups based on the degree of troponin elevation. With increasing concentrations of hs-cTnT, patients were progressively more likely to have diabetes and atrial fibrillation, to have New York Heart Association class III-IV symptoms and been hospitalized for heart failure within the prior year, and to have elevated levels of natriuretic peptides and worse renal function (P-trend < 0.0001 for all comparisons), but importantly, the troponin groups did not differ with respect to ejection fraction. A linear relationship was observed between the logarithm of hs-cTnT and the combined risk of cardiovascular death or hospitalization for heart failure (P = 0.0015). When treated with placebo, patients with the highest levels of hs-cTnT had risks of cardiovascular death and hospitalization for heart failure that were 3-5 fold greater than those with values in the normal range. Patients with higher levels of hs-cTnT were also more likely to experience worsening of renal function and serious adverse renal events and showed the least improvement in health status (as measured by the Kansas City Cardiomyopathy Questionnaire). When compared with placebo, empagliflozin reduced the combined risk of cardiovascular death or hospitalization for heart failure, regardless of the baseline level of hs-cTnT, whether the effects of treatment were analysed as hazard ratios or absolute risk reductions. CONCLUSIONS: Elevations in hs-cTnT reflect the clinical severity, stability and prognosis of patients with heart failure and a reduced ejection fraction, with biomarkers, comorbidities, clinical course and risks that are proportional to the magnitude of hs-cTnT elevation. Empagliflozin exerted favourable effects on heart failure and renal outcomes, regardless of the baseline concentration of hs-cTnT

Empagliflozin Improves Cardiovascular and Renal Outcomes in Heart Failure Irrespective of Systolic Blood Pressure.

BACKGROUND: Empagliflozin reduces the risk of cardiovascular death or heart failure (HF) hospitalization in patients with reduced ejection fraction. Its interplay with systolic blood pressure (SBP) is not known. OBJECTIVES: The goal of this study was to evaluate the interplay of SBP and the effects of empagliflozin in EMPEROR-Reduced (Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Reduced Ejection Fraction). METHODS: Study patients (N = 3,730) were randomly assigned to groups according to SBP at baseline (130 mm Hg, n = 1,047). This study explored the influence of SBP on the effects of empagliflozin on cardiovascular death or HF hospitalization (primary outcome), as well as on total HF hospitalizations, rate of decline in estimated glomerular filtration rate, renal outcomes, and empagliflozin's effects and significance on SBP. RESULTS: Over a median of 16 months considering only patients receiving placebo, baseline SBP and the risk of cardiovascular death or hospitalization for HF (P trend = 0.0015) were inversely related. Corrected for placebo, a slight early increase was observed in SBP at 130 mm Hg. These between-group differences were of borderline significance (P for interaction trend = 0.05-0.10) after 4 and 12 weeks but were not significant later. SBP at baseline did not influence the effect of empagliflozin to reduce the risk of HF events or renal endpoints. When treated with empagliflozin, patients with SBP <110 mm Hg did not have an increased rate of symptomatic hypotension. CONCLUSIONS: Empagliflozin was effective and safe, with no meaningful interaction between SBP and the effects of empagliflozin in the EMPEROR-Reduced trial. (Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Reduced Ejection Fraction [EMPEROR-Reduced]; NCT03057977)

Effects of empagliflozin on cardiovascular and renal outcomes in heart failure with reduced ejection fraction according to age: A secondary analysis of EMPEROR-Reduced

Aims Empagliflozin improves cardiovascular and renal outcomes in patients with heart failure (HF) and reduced ejection fraction (HFrEF), but its efficacy and safety across patient's age is not well established. Methods and results We assessed the effects of empagliflozin (10 mg daily) versus placebo, on top of standard HF therapy, in symptomatic HFrEF patients with a left ventricular ejection fraction = 75 years). The primary endpoint was a composite of cardiovascular death or HF hospitalization. Key secondary endpoints included first and recurrent HF hospitalizations and slope of change in estimated glomerular filtration rate (eGFR); the latter was supported by an analysis of a renal composite endpoint (chronic dialysis or renal transplantation or profound and sustained reduction in eGFR). Of 3730 patients, 38% were = 75 years. Compared with placebo, empagliflozin reduced the primary endpoint consistently across the three age groups (hazard ratio 0.71 [95% confidence interval 0.57-0.89] for = 75 years, interaction p-trend test = 0.24). The effects of empagliflozin were also consistent across age groups for key secondary endpoints of first and recurrent HF hospitalization (p-trend = 0.30), the rate of decline in eGFR (p-trend = 0.78) and the renal composite (p-trend = 0.94). Adverse events (AEs), serious AEs and AEs leading to drug discontinuation increased with age in both treatment arms, but empagliflozin did not increase their incidence over placebo within each age group. Conclusion The efficacy and safety of empagliflozin in improving cardiovascular and renal outcomes in HFrEF was consistent across the spectrum of age, including older patients (aged >= 75)

Evaluation of the effects of sodium-glucose co-transporter 2 inhibition with empagliflozin on morbidity and mortality in patients with chronic heart failure and a preserved ejection fraction: rationale for and design of the EMPEROR-Preserved Trial.

BACKGROUND: The principal biological processes that characterize heart failure with a preserved ejection fraction (HFpEF) are systemic inflammation, epicardial adipose tissue accumulation, coronary microcirculatory rarefaction, myocardial fibrosis and vascular stiffness; the resulting impairment of left ventricular and aortic distensibility (especially when accompanied by impaired glomerular function and sodium retention) causes increases in cardiac filling pressures and exertional dyspnoea despite the relative preservation of left ventricular ejection fraction. Independently of their actions on blood glucose, sodium-glucose co-transporter 2 (SGLT2) inhibitors exert a broad range of biological effects (including actions to inhibit cardiac inflammation and fibrosis, antagonize sodium retention and improve glomerular function) that can ameliorate the pathophysiological derangements in HFpEF. Such SGLT2 inhibitors exert favourable effects in experimental models of HFpEF and have been found in large-scale trials to reduce the risk for serious heart failure events in patients with type 2 diabetes, many of whom were retrospectively identified as having HFpEF. STUDY DESIGN: The EMPEROR-Preserved Trial is enrolling ≈5750 patients with HFpEF (ejection fraction >40%), with and without type 2 diabetes, who are randomized to receive placebo or empagliflozin 10 mg/day, which is added to all appropriate treatments for HFpEF and co-morbidities. STUDY AIMS: The primary endpoint is the time-to-first-event analysis of the combined risk for cardiovascular death or hospitalization for heart failure. The trial will also evaluate the effects of empagliflozin on renal function, cardiovascular death, all-cause mortality and recurrent hospitalization events, and will assess a wide range of biomarkers that reflect important pathophysiological mechanisms that may drive the evolution of HFpEF. The EMPEROR-Preserved Trial is well positioned to determine if empagliflozin can have a meaningful impact on the course of HFpEF, a disorder for which there are currently few therapeutic options