Medico-Legal Implications and Regulatory Frameworks of Regenerative Orthopaedics.

Regenerative orthopaedics has revolutionized traditional medicine, which represents a giant leap in science and research. The knowledge of the medico-legal implications and regulatory framework of this branch is vital for clinicians and researchers to go forward smoothly. This systematic review of the literature should shed light on these considerations and provide a comprehensive knowledge of the various implications and laws governing practice and research. The wide plethora of knowledge in the use of regenerative orthopaedics should be complemented by updated regulations and clinicians' grasp of knowledge on regenerative medicine. The review focused on peer-reviewed published articles concerned with the topic and outlined common medico-legal issues and the current regulatory frameworks in various countries. The articles suggest that developed nations like the US have faced several lawsuits in this field, and a few countries in Europe like Italy and Germany, which were frontrunners in this field based on research, have fallen back due to emerging legal and regulatory policies. Undoubtedly, regenerative orthopaedics holds the key to future orthopaedics, but the world is skeptical of this concept, and laws and regulatory frameworks can curb it if not guided well. In India, this field has received prime attention, but at a slow pace when compared to the laws. After reviewing 113 articles, we analysed eight critically in this systematic review to emphasize the comparative global frameworks, daily medico-legal problems, and solutions for the branch of regenerative orthopaedics.

Clinical Characteristics, Complications, and Treatment Practices in Patients With RHD: 6-Year Results From HP-RHD Registry.

BACKGROUND: Despite the high prevalence of rheumatic heart disease (RHD) in developing countries such as India, data on characteristics, complications, and treatment practices are lacking. The HP-RHD (Himachal Pradesh Rheumatic Heart Disease) registry aimed at reporting these parameters in patients with RHD from a northern state of India. METHODS: A total of 2,005 consecutive patients of RHD were enrolled over a period of 6 years (2011 to 2016) in the present study. The clinical characteristics, complications, and treatment practices were systematically recorded. RESULTS: The mean age for patients with RHD was 40.3 ± 14.3 (range 5 to 83 years). RHD predominantly affected females (72.3%) and population from rural background (92%). Multivalvular involvement was frequent (43.2%), mitral valve was the commonest affected valve (83.3%). The majority of the patients had moderate-to-severe valvular dysfunction (69.3%). Mitral and tricuspid valve involvement was more frequent in female subjects compared with more frequent aortic valve involvement in male subjects (p < 0.001). The major adverse cardiovascular events were recorded in 23.4% patients at the time of registry and comprised mainly advanced heart failure (15.6%), peripheral embolism (4.1%), and stroke (3.9%). The independent risk determinants of major adverse cardiovascular events (were advanced age (odds ratio [OR]: 1.01; 95% confidence interval [CI]: 1.00-1.02), severe mitral stenosis (OR: 1.73; 95% CI: 1.34-2.20), severe tricuspid regurgitation (OR: 2.11; 95% CI: 1.48-3.02), presence of pulmonary artery hypertension (OR: 1.33; 95% CI: 1.04-1.69), and atrial fibrillation (OR: 1.64; 95% CI: 1.28-2.11). Evidence-based use of oral anticoagulant therapy was documented in 77.7% of high-risk patients. Only 28.5% of study population was receiving secondary prophylaxis. CONCLUSIONS: Complications in patients with RHD increase with age and worsening valvular dysfunction. Programs focused on early detection and evidence-based management will assist in improving outcomes.

Prevalence, risk factors, and significance of iron deficiency and anemia in nonischemic heart failure patients with reduced ejection fraction from a Himachal Pradesh heart failure registry.

BACKGROUND: The study aimed to estimate the prevalence, risk determinants, and its clinical significance of iron deficiency and anemia in patients of nonischemic heart failure with reduced ejection fraction (HFrEF). METHODS: Serum ferritin, transferrin saturation, and the hemoglobin (Hb) levels were measured in 226 consecutive patients with HFrEF diagnosed based on the left ventricular ejection fraction ≤ 45% and absence of coronary artery luminal narrowing of more than 50%, in a prospective tertiary care hospital-based heart failure registry. Patients with the New York Heart Association functional class III/IV were classified as patients with advanced heart failure. Multivariable logistic regression modeling was performed to assess the risk determinants of iron deficiency and anemia and their clinical significance as the risk factors for advanced heart failure. Odds ratio with 95% confidence interval (CI) was reported as the estimates of the strength of association between exposure and outcome variables. RESULTS: Iron deficiency and anemia were prevalent in 58.8% (52.2%-65.1%) and 35.8% (29.8%-42.3%) of patients, respectively. Female gender [OR 3.5 (95% CI 1.9-6.5)], history of bleeding [OR 11.7 (95% CI 1.4-101.2)], and vegetarian diet [OR 2.5 (95% CI 1.4-4.6)] were significantly associated with iron deficiency, while diabetes [OR 3.0 (95% CI 1.40-6.5)], estimated glomerular filtration rate [OR 0.98 (95% CI 0.97-0.99)], history of bleeding [OR 13.0 (95% CI 2.3-70.9)], and female gender [OR 2.9 (95% CI 1.5-5.7)] had significant association with anemia. The Hb level (OR 0.82 (95% CI 0.70-0.96) and transferrin saturation (OR 0.98 (95% CI 0.96-0.99)] had a significant inverse association with symptoms of advanced heart failure. CONCLUSION: Iron deficiency and anemia are common comorbidities associated with HFrEF. Low Hb and transferrin saturation are significantly associated with advanced heart failure. The findings have important implications in the management of heart failure.