Patient Outcomes for Anterior Multi-level Cervical Fusions: A Comparative Analysis of AO and DOC Instrumentation

The purpose of this study is to compare the efficacy of the DePuy-Acromed DOC implant with the Synthes AO plate by means of analysis of subjective and objective data. A retrospective review of 56 consecutive instrumented, anterior multi-level cervical fusions by two orthopedic spine specialists was completed. Biographical, clinical, surgical and radiographic data was collected for patients who underwent anterior multi-level cervical fusions between 12/13/96 and 4/8/99. Twenty-five of the patients received a DOC implant and 31 received the AO plate. No major complications occurred during or following surgery directly related to either implant. Both groups however, did contain cases of transient dysphasia and lingering pain. Generally, patients that received the DOC implant experienced a greater percent decrease in post-operative pain levels though both study groups exhibited significant improvement. The use of a DOC implant was also correlated with a loss of fewer working days amongst those in the study group. Psuedoarthrosis and a return to pre-operative pain levels occurred in patients using the AO implant at higher frequencies than in those with the DOC. Screw loosening occurred less frequently with the AO plate than with the DOC implant. However, the one case of AO screw loosening required subsequent hardware removal. The DOC also appears to have the added benefit of offering a dynamic system that can reduce the amount of load shielding of the bone graft during the time that it is fusing. It appears that the newer DOC implant offers desirable benefits over the traditional AO locking plate. The dysphasia and cost were liabilities that seem to be offset by the patient satisfaction level with surgeries involving the DOC implant

The Chattanooga Procedure: A New Technique Used for Anterior Multi-level Cervical Fusions

STUDY DESIGN: A preliminary assessment of anterior cervical fusion performed with interbody cage and DOC plate. OBJECTIVES: To describe and evaluate the efficacy and safety of the Chattanooga Procedure , a modified technique in achieving anterior cervical fusion. SUMMARY OF BACKGROUND DATA: Anterior cervical fusion with interbody bone graft and anterior plating is connnonly performed. Unfortunately, the plate has been reported to shield the graft from loading thus reducing fusion rates. The use of interbody fusion cages has been effective in the lumbar spine and has gained acceptance in the cervical spine. METHODS:. Twenty-five patients received The Chattanooga Procedure between 7/24/98 and 4/8/99. All patients had anterior discectomies and carpectomies, placement of a Harms cage packed with carpectomy bone, and application ofDePuy-Acromed DOC. Fusion was defined by radiographic evidence of trabecular bone bridging across the Harms cage. CT scans were performed on twelve randomly chosen patients to verify fusion. No external bracing was used except a soft collar as needed. Pre- and post-operative pain and functional capacity data were collected and statistically analyzed using paired t-tests. RESULTS: There were no cases of pseudoarthrosis, major neurological, vascular, or wound complications. Only one case of unresolved dysphasia was noted. The average operative time (11 0 minutes) was comparable to standard instrumented multi-level anterior cervical fusion surgeries. The average estimated blood loss was 113 ml (range, 50-750 ml). Both visual analog pain scale and Oswestry functional capacity data were significantly improved post-operatively (p\u3c 0.01). DISCUSSION: Advantages of the Chattanooga Procedure include immediate stability, support, elimination of donor site pain to iliac crest bone autograft, and a decrease in pseudoarthrosis by dividing the fusion surfaces by half. Concerns regarding this technique include an increased risk for dysphasia due to the DOC\u27s high profile. Pseudoarthrosis or instrumentation migration could also become problematic since the removal of the Harms cage could be difficult if necessary

Prognostic significance of precordial ST segment depression during inferior myocardial infarction in the thrombolytic era: Results in 16,521 patients

Objectives. We examined the prognostic significance of precordial ST segment depression among patients with an acute inferior myocardial infarction. Background. Although precordial ST segment depression has been associated with a poor prognosis, this correlation has not been adequately quantified, partly because of small sample sizes and methodologic limitations in previous studies. Methods. We examined the clinical and angiographic outcomes of 16,521 patients with an acute inferior myocardial infarction who underwent thrombolysis in the Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO-I) study. Patients were classified into those without precordial ST segment depression (n = 6,422 [38.9%]), those with ST segment depression in leads V1 to V3 only (n = 5,850 [35.4%]), those with ST segment depression in leads V4 to V6 only (n = 876 [5.3%]) and those with ST segment depression in both leads V1 to V3 and leads V4 to V6 (n = 3,373 [20.4%]) on initial electrocardiography. Outcome measures included postinfarction complications (second- or third-degree heart block, congestive heart failure or shock) and 30-day and 1-year mortality. Results. Patients with precordial ST segment depression had larger infarctions, more postinfarction complications and a higher mortality rate than those without precordial ST segment depression (4.7% vs. 3.2% at 30 days; 5.0% vs. 3.4% at 1 year; both p < 0.001), regardless of whether ST segment depression was noted in leads V1 to V6 or in leads V4 to V6. The magnitude of precordial ST segment depression (sum of leads V1 to V6) added significant independent prognostic information after adjustment for clinical risk factors; the risk of 30-day mortality increased by 36% for every 0.5 mV of precordial ST segment depression. Conclusions. Assessment of the magnitude of precordial ST segment depression is useful for acute risk stratification in patients with an inferior myocardial infarction

HIV and COVID-19 co-infection : mild infection or prolonged transmission

BACKGROUND. Comorbid conditions may be associated with severe COVID-19. However, there is no evidence to suggest that people living with HIV have a higher risk of contracting SARS-CoV-2 or, if infected, have more severe disease. OBJECTIVE. To describe three patients with HIV and COVID-19 co-infection. METHOD. The study was conducted in a private hospital in Gauteng Province, South Africa. All three patients were known to have HIV disease and were treated with chronic antiretroviral medication. All patients admitted to the unit were screened for chronic conditions such as HIV, tuberculosis, diabetes and hypertension. They were admitted to the hospital after being diagnosed with COVID-19, this being confirmed by positive reverse transcription polymerase chain reaction (RT-PCR) tests. RESULTS. The combination of HIV and SARS-CoV-2 (HIVCO) with comorbidities in case 1 (dialysis-dependent end-stage renal failure and hypertension) resulted in severe illness, a long hospital stay and protracted viral shedding. The protracted shedding pattern (>60 days) was confirmed by multiple positive RT-PCR tests and positive viral cultures obtained after 60 days. Despite comorbidities, case 2 (Takayasu’s disease in remission, dyslipidaemia and previous deep vein thrombosis) and case 3 (hypertension and diabetes) presented with mild illness. The mild clinical course and negative RT-PCR tests in cases 2 and 3 indicated resolution of infection. CONCLUSION. Patients with HIVCO and comorbidities may present with mild or severe illness. Unusually long SARS-CoV-2 shedding is a risk for disease transmission, and its association with HIV, other immunocompromised conditions and comorbidities is unclear. We describe a shedding classification that may assist in identifying and managing infectious subsets of patients. Multiple SARS-CoV-2 tests and viral cultures may be necessary to confirm protracted shedding.http://www.samj.org.za/index.php/samjam2021School of Health Systems and Public Health (SHSPH

Maternal vitamin D deficiency and developmental origins of health and disease (DOHaD)

Vitamin D is an essential nutrient that is metabolized in the body to generate an active metabolite (1, 25(OH)2D) with hormone-like activity and highly diverse roles in cellular function. Vitamin D deficiency (VDD) is a prevalent but easily p reventable nutritional disturbance. Emerging evidence demonstrates the importance of s ufficient vitamin D concentrations during fetal life with deficiencies leading to long-term effects into adulthood. Here, we provide a detailed review and perspective of evidence for the role of maternal VDD in offspring long-term health, particularly as it relates to developmental origins of health and disease (DOHaD). We focus on the roles in neurobehavioral and cardiometabolic disorders in humans and highlight recent finding s from zebrafish and rodent models that probe potential mechanisms linking early life VDD to later life health outcomes. Moreover, we explore evidence implicating epigenetic mechanisms as a mediator of this link. Gaps in our current understanding of how maternal VDD might result in deleterious offspring outcomes later in life are also addressed

Hypertension Control in Adults with Diabetes Mellitus and Recurrent Cardiovascular Events: Global Results from the Trial Evaluating Cardiovascular Outcomes with Sitagliptin

Systolic blood pressure (SBP) treatment targets for adults with diabetes mellitus remain unclear. SBP levels among 12 275 adults with diabetes mellitus, prior cardiovascular disease, and treated hypertension were evaluated in the TECOS (Trial Evaluating Cardiovascular Outcomes With Sitagliptin) randomized trial of sitagliptin versus placebo. The association between baseline SBP and recurrent cardiovascular disease was evaluated using multivariable Cox proportional hazards modeling with restricted cubic splines, adjusting for clinical characteristics. Kaplan-Meier curves by baseline SBP were created to assess time to cardiovascular disease and 2 potential hypotension-related adverse events: worsening kidney function and fractures. The association between time-updated SBP and outcomes was examined using multivariable Cox proportional hazards models. Overall, 42.2% of adults with diabetes mellitus, cardiovascular disease, and hypertension had an SBP ≥140 mm Hg. The association between SBP and cardiovascular disease risk was U shaped, with a nadir ≈130 mm Hg. When the analysis was restricted to those with baseline SBP of 110 to 150 mm Hg, the adjusted association between SBP and cardiovascular disease risk was flat (hazard ratio per 10-mm Hg increase, 0.96; 95% confidence interval, 0.91-1.02). There was no association between SBP and risk of fracture. Above 150 mm Hg, higher SBP was associated with increasing risk of worsening kidney function (hazard ratio per 10-mm Hg increase, 1.10; 95% confidence interval, 1.02-1.18). Many patients with diabetes mellitus have uncontrolled hypertension. The U-shaped association between SBP and cardiovascular disease events was largely driven by those with very high or low SBP, with no difference in cardiovascular disease risk between 110 and 150 mm Hg. Lower SBP was not associated with higher risks of fractures or worsening kidney function

Sitagliptin and risk of fractures in type 2 diabetes: Results from the TECOS trial

Aim: To examine fracture incidence among participants in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS). Research design and methods: We used data from 14 671 participants in the TECOS study who were randomized double-blind to sitagliptin (n = 7332) or placebo (n = 7339). Cumulative fracture incidence rates were calculated and their association with study treatment assignment was examined using multivariable Cox proportional hazards regression. Results: The baseline mean (standard deviation) participant age was 65.5 (8.0) years, diabetes duration was 11.6 (8.1) years and glycated haemoglobin level was 7.2 (0.5)% [55.2 (5.5) mmol/mol], and 29.3% of participants were women and 32.1% were non-white. During 43 222 person-years’ follow-up, 375 (2.6%; 8.7 per 1000 person-years) had a fracture; 146 were major osteoporotic fractures (hip, n = 34; upper extremity, n = 81; and clinical spine, n = 31). Adjusted analyses showed fracture risk increased independently with older age (P <.001), female sex (P <.001), white race (P <.001), lower diastolic blood pressure (P <.001) and diabetic neuropathy (P =.003). Sitagliptin, compared with placebo, was not associated with a higher fracture risk [189 vs 186 incident fractures: unadjusted hazard ratio (HR) 1.01, 95% confidence interval (CI) 0.82 to 1.23, P =.944; adjusted HR 1.03, P =.745], major osteoporotic fractures (P =.673) or hip fractures (P =.761). Insulin therapy was associated with a higher fracture risk (HR 1.40, 95% CI 1.02-1.91; P =.035), and metformin with a lower risk (HR 0.76, 95% CI 0.59-0.98; P =.035). Conclusion: Fractures were common among people with diabetes in the TECOS study, but were not related to sitagliptin therapy. Insulin and metformin treatment were associated with higher and lower fracture risks, respectively

Longitudinal medical resources and costs among type 2 diabetes patients participating in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS)

Aims: TECOS, a cardiovascular safety trial (ClinicalTrials.gov identifier: NCT00790205) involving 14 671 patients with type 2 diabetes and cardiovascular disease, demonstrated that sitagliptin was non-inferior to placebo for the primary composite cardiovascular outcome when added to best usual care. This study tested hypotheses that medical resource use and costs differed between these 2 treatment strategies. Materials and methods: Information concerning medical resource use was collected on case report forms throughout the trial and was valued using US costs for: Medicare payments for hospitalizations, medical procedures and outpatient visits, and wholesale acquisition costs (WAC) for diabetes-related medications. Hierarchical generalized linear models were used to compare resource use and US costs, accounting for variable intercountry practice patterns. Sensitivity analyses included resource valuation using English costs for a UK perspective. Results: There were no significant differences in hospitalizations, inpatient days, medical procedures, or outpatient visits during follow-up (mean and median 3.0 years in both groups). Hospitalization rates appeared to diverge after 2 years, with lower rates among sitagliptin-treated vs placebo patients after 2.5 years (relative rate, 0.90 [95% CI, 0.83-0.97]; P =.01). Mean medical costs, exclusive of study medication, were 11 937 USD in the sitagliptin arm and 12 409 USD in the placebo arm (P =.06). Mean sitagliptin costs based on undiscounted WAC were 9978 USD per patient. Differential UK total costs including study drug costs were smaller (911 GBP), primarily because of lower mean costs for sitagliptin (1072 GBP). Conclusions: Lower hospitalization rates across time with sitagliptin slightly offset sitagliptin treatment costs over 3 years in type 2 diabetes patients at high risk for cardiovascular events

Cluster Analysis of Cardiovascular Phenotypes in Patients With Type 2 Diabetes and Established Atherosclerotic Cardiovascular Disease: A Potential Approach to Precision Medicine

OBJECTIVE Phenotypic heterogeneity among patients with type 2 diabetes mellitus (T2DM) and atherosclerotic cardiovascular disease (ASCVD) is ill defined. We used cluster analysis machine-learning algorithms to identify phenotypes among trial participants with T2DM and ASCVD. RESEARCH DESIGN AND METHODS We used data from the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) study (n = 14,671), a cardiovascular outcome safety trial comparing sitagliptin with placebo in patients with T2DM and ASCVD (median follow-up 3.0 years). Cluster analysis using 40 baseline variables was conducted, with associations between clusters and the primary composite outcome (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina) assessed by Cox proportional hazards models. We replicated the results using the Exenatide Study of Cardiovascular Event Lowering (EXSCEL) trial. RESULTS Four distinct phenotypes were identified: Cluster I included Caucasian men with a high prevalence of coronary artery disease; cluster II included Asian patients with a low BMI; cluster III included women with noncoronary ASCVD disease; and cluster IV included patients with heart failure and kidney dysfunction. The primary outcome occurred, respectively, in 11.6%, 8.6%, 10.3%, and 16.8% of patients in clusters I to IV. The crude difference in cardiovascular risk for the highest versus lowest risk cluster (cluster IV vs. II) was statistically significant (hazard ratio 2.74 [95% CI 2.29–3.29]). Similar phenotypes and outcomes were identified in EXSCEL. CONCLUSIONS In patients with T2DM and ASCVD, cluster analysis identified four clinically distinct groups. Further cardiovascular phenotyping is warranted to inform patient care and optimize clinical trial designs

Causes of death in a contemporary cohort of patients with type 2 diabetes and atherosclerotic cardiovascular disease: Insights from the TECOS trial

Objective: We evaluated the specific causes of death and their associated risk factors in a contemporary cohort of patients with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD). Research Design and Methods: We used data from the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) study (n = 14,671), a cardiovascular (CV) safety trial adding sitagliptin versus placebo to usual care in patients with type 2 diabetes and ASCVD (median follow-up 3 years). An independent committee blinded to treatment assignment adjudicated each cause of death. Cox proportional hazards models were used to identify risk factors associated with each outcome. Results: A total of 1,084 deaths were adjudicated as the following: 530 CV (1.2/100 patientyears [PY], 49% of deaths), 338 non-CV (0.77/100 PY, 31% of deaths), and 216 unknown (0.49/100 PY, 20% of deaths). Themost common CV death was sudden death (n = 145, 27% of CV death) followed by acute myocardial infarction (MI)/stroke (n = 113 [MI n = 48, stroke n = 65], 21% of CV death) and heart failure (HF) (n = 63, 12% of CV death). Themost common non-CV deathwas malignancy (n = 154, 46% of non-CV death). The risk of specific CV death subcategories was lower among patients with no baseline history of HF, including sudden death (hazard ratio [HR] 0.4; P = 0.0036), MI/stroke death (HR 0.47; P = 0.049), and HF death (HR 0.29; P = 0.0057). Conclusions: In this analysis of a contemporary cohort of patients with diabetes and ASCVD, sudden death was the most common subcategory of CV death. HF prevention may represent an avenue to reduce the risk of specific CV death subcategories