Clinical outcomes of MANTA vs suture-based vascular closure devices after transcatheter aortic valve replacement: An updated meta-analysis

Objective: A recently published randomized control trial showed different results with suture-based vascular closure device (VCD) than plug-based VCD in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). The learning curve for MANTA device is steep, while the learning curve for suture based VCD is shallow as the devices are quite different. In this meta-analysis, we have compared suture-based (ProGlide and Prostar XL) vs plug-based VCDs (MANTA). Methods: We performed a meta-analysis of all published studies (using PubMed/Medline and Cochrane databases) reporting the clinical outcome of plug-based vs suture-based VCDs in transfemoral TAVR patients. Results: We included nine studies with a total of 2865 patients (plug-based n ¼ 1631, suture-based n ¼ 1234). There was no significant difference in primary outcome of all bleeding when using plugbased as opposed to suture-based VCDs (RR 1.14 [0.62e2.06] I2 ¼ 72%). There was no significant difference in the incidence of secondary outcomes between two groups including major life threatening bleeding (RR 1.16 [0.38e3.58] I2 ¼ 65%), major vascular complications (RR 0.84 [0.35e2.00] I2 ¼ 55%), minor vascular complications (RR 1.05 [0.56e1.95] I2 ¼ 42%), pseudo aneurysm (RR 1.84 [0.11e29.98] I 2 ¼ 44%), stenosis-dissection (RR 0.98 [0.66e1.47] I2 ¼ 0%), VCD failure (RR 1.71 [0.96e3.04] I2 ¼ 0%), and blood transfusion (RR 1.01 [0.38e2.71], I2 ¼ 61%). Conclusion: Large bore arteriotomy closure with plug-based VCD was not superior to suture-based VCDs in this transfemoral TAVR population. There was very frequent use of secondary VCDs in suture-based VCD group which is not practical when using MANTA. Additional high-powered studies are required to determine the safety and efficacy of MANTA device.

Clinical Retrospective and Prospective Evaluation of Efficacy and Safety of Reteplase in STEMI Patients.

Reteplase is a third-generation recombinant form of t- PA (tissue plasminogen activator). A phase–III prospective, multi-centric trial and retrospective, post-marketing surveillance (PMS) of reteplase have been conducted to evaluate the efficacy and safety of reteplase in patients with ST segment Elevation Myocardial Infarction (STEMI). Phase-III trial was a prospective, multi-centric, open-label study conducted across 15 centers in India. 80 patients out of 83 screened were enrolled in the study. Patients with STEMI admitted to an intensive care unit in a hospital within 6 hours of onset of symptoms and meeting all eligibility criteria were enrolled in the study. Each patient received a total dose of 20 units of reteplase. The dose was given as two 10 unit intravenous injections each over two minutes, no more than 30 minutes apart. The primary objective of the study was to evaluate the all cause mortality rate at 30 days post-dosing in patients with STEMI following treatment with reteplase. Safety assessment was based on treatment emergent adverse events, physical examinations, vital signs, ECGs, echocardiography and safety laboratory tests. A Post Marketing Surveillance (PMS) following the marketing approval in India was undertaken to assess the safety profile of reteplase in patients with STEMI and/or recent left bundle branch block. Reteplase was administered as two bolus injections of 10 units each. Each bolus was administered as a slow intravenous injection over 2 minutes. Total 204 patients’ data has been considered for the analysis in present post-marketing study. The results of both these studies are discussed. In both these studies, reteplase efficacy and safety were well established in treatment of patients with ST segment elevation Myocardial Infarction (STEMI).

Original research paper radiological study of disappearance of tri-radiate cartilage in pelvic-bone in Gujarati population.

For medico-legal purposes evidence of age is very essential in various types of cases such as Identification, Consent, Rape, Attainment of Majority, and Eligibility for Employment, etc. Various work done on the study of age determination by the study of appearance of ossification centers and epiphyseal union of different bones in India as well as abroad indicate a reasonable variation. Majority of them conclude that, the ossification and epiphyseal union of a bone vary in different part of the world. To the best of our knowledge very little work has been done on the study of disappearance of tri-radiate cartilage out of various bony parts useful for age estimation. The present study comprising of 50 subjects ( male=35; female=15),was carried out during the period January 2000 to July 2001 at the Forensic Medicine department and Department of radiology, B.J. Medical College, Ahmedabad.