NOTTO Guidelines for Vaccine Induced Thrombotic Thrombocytopenia in Organ Donation and Transplantation.

From the context of organ donation, COVID-19 vaccine-induced thrombotic thrombocytopenia (VITT) is important as there is an ethical dilemma in utilizing versus discarding organs from potential donors succumbing to VITT. This consensus statement is an attempt by the National Organ and Tissue Transplant Organization (NOTTO) apex technical committees India to formulate the guidelines for deceased organ donation and transplantation in relation to VITT to help in appropriate decision making. VITT is a rare entity, but a meticulous approach should be taken by the Organ Procurement Organization's (OPO) team in screening such cases. All such cases must be strictly notified to the national authorities like NOTTO, as a resource for data collection and ensuring compliance withprotocols in the management of adverse events following immunization. Organs from any patient who developed thrombotic events up to 4 weeks after adenoviral vector-based vaccination should be linked to VITT and investigated appropriately. The viability of the organs must be thoroughly checked by the OPO, and the final decision in relation to organ use should be decided by the expert committee of the OPO team consisting of a virologist, a hematologist, and atreating team. Considering the organ shortage, in case of suspected/confirmed VITT, both clinicians and patients should consider the risk-benefit equationbased on available experience, and an appropriate written informed consent of potential recipients and family members should be obtained before transplantation of organs from suspected or proven VITT donors.

Simulation of non-Newtonian flow of blood in a modified laparoscopic forceps used in minimally invasive surgery.

During surgeries, blood often oozes out of the operated tissue and this has to be sucked out by the S-I device. Blood is more viscous than saline, the cleaning fluid is used in the S-I process. Therefore, for a more comprehensive CFD flow analysis of the improved forceps is simulated in the present work for different driving pressures. The resulting flow rate of blood is compared among the prospective designs and the S-I device currently in use. The new surgical forceps eliminates re-insertion of dissector with suction-irrigator and is reusable, multi-functional, non-toxic, corrosion resistant, toughened, and cost-effective.

Design and fluid flow simulation of modified laparoscopic forceps.

Laparoscopic surgery has gained prominence in recent decades and employed in minimally invasive surgeries to avoid massive cuts resulting in a reduction in pain, the chance of infection, and duration of stay in the hospital. Maryland forceps, which belongs to the category of grasper instruments, are often used in minimally invasive surgeries to hold, pull, push, manipulate, and perform dissection operations. During laparoscopic surgeries, often blood and other body fluids ooze from the site of surgery. Typically, suction-irrigation (SI) devices are used to periodically clear these fluids to get a better view of the site of surgery. To achieve this, the removal and insertion of multiple instruments are required. This process has to be repeated numerous times, which significantly increases the time needed for surgery. Literature survey and feedback from practicing surgeons suggest that this can be avoided by improving the current design of forceps. In this article, a modified design is proposed by combining the SI feature with the existing form of Maryland forceps. The modified design is first modeled in SolidWorks and then analyzed for fluid flow using ANSYS Fluent. Parametric analysis is performed to obtain the optimal design for the proposed multi-functional instrument, which can potentially improve the overall efficiency of the laparoscopic surgical process.

Early hemodynamic performance of the Trifecta™ surgical bioprosthesis aortic valve in Indian patient population: 12 month outcomes of the EVEREST post-market study.

BACKGROUND: Indian patients undergoing surgical aortic valve replacement (SAVR) differ from western populations with respect to aortic annulus size and valve disease morphology. The purpose of this post-market, non-randomized observational study was to evaluate the early hemodynamic performance of the Trifecta™ bioprosthesis (Abbott, previously St. Jude Medical, Minneapolis, US) in an Indian patient population. METHODS: From January 2014 to September 2015, 100 patients (mean age 64.4 ± 7.1 years, 62% male) undergoing SAVR for valve disease (68% stenosis, 7% insufficiency, 25% mixed pathology) were enrolled across 10 centers in India. Patients implanted with a 19-27 mm Trifecta™ valve were eligible to participate and were prospectively followed for 12-months post-implantation. Echocardiographic hemodynamic performance was evaluated at pre-implant, pre-discharge and at 12-months by an independent core laboratory. Adverse events were adjudicated by the study sponsor. Functional status at 12-months was assessed according to NYHA classification. Continuous data was summarized using descriptive statistics (mean &standard deviation,) and categorical data was summarized using frequencies and percentages. RESULT: Ninety patients (mean age 64.5, 62.2% male) completed the 12-month follow up. Significant improvements in hemodynamic valve performance were reported in 81 patients with available echocardiographic data at 12 months. Compared to baseline at 12-month follow up visit, mean effective orifice area increased from 0.75cm2 to 1.61cm2 (p < 0.0001), mean pressure gradient reduced to 10.42 mmHg from 51.47 mmHg (p < 0.0001), cardiac output increased from 4.46 l/min to 4.85 l/min (P 0.9254). Compared to baseline, functional status improved by ≥1 NYHA class in 75% of patients at 12 months (95% Clopper-Pearson (Exact) confidence limit [64.6%, 83.6%]). No instances of early mortality (< 30 days from index procedure) or structural valve dysfunction were reported. CONCLUSION: In an Indian patient population, implantation of the Trifecta™ bioprosthesis is shown to be safe and associated with favorable early hemodynamic performance and improved functional status at 12 months. TRIAL REGISTRATION: The clinical study has been registered under Clinical Trial Registry-India ( http://www.ctri.nic.in ) and registration number is CTRI/2014/02/004434 registered on 25 February 2014 retrospectively registered.

Evaluation of the autologous bone marrow mononuclear therapy and functional restoration in the scarred myocardium by imaging analysis.

A 62-year-old male patient with previous history of myocardial infarction, akinetic myocardial segments, and an ejection fraction of 31% with the NYHA class III category was selected for the autologous bone marrow (ABM)-derived mononuclear cell fraction injection during CABG surgery. Nitrate augmented myocardial tracer uptake was imaged by ECG gated SPECT pre- and 1 year post-ABM therapy, using radiotracer Tc99m Sestamibi. The baseline gated SPECT demonstrated full thickness infarct in 40% area of LAD territory. Bone marrow aspirate of 20.0 ml from sternum yielding a mono nuclear cell fraction of 4.5 × 10(7) cells/ml was suspended in 2.0 ml of sterile normal saline to be injected at eight sites of the injured myocardium. There were no apparent side effects due to the procedure, i.e., life threatening events, major bleeds, reaction, or shock. The case was followed at the end of 1, 3, 6 months by ECG and Holter monitor and ECG gated SPECT at the end of 12 months. The gated SPECT images demonstrated mild but definitely improved tracer uptake within part of the infarcted segments along with improvement in ejection fraction to 45%, and a clinical change in the NYHA Class to II. Cell-based therapy may offer benefits of induction of normal tissue microenvironment.