Archive for month: April, 2024

“The U.S. approval of TriClip is a significant advancement for people suffering from tricuspid regurgitation, a heart condition that negatively impacts their quality of life and puts them at grave risk of serious health issues,” said Paul Sorajja, M.D., the Roger L. and Lynn C. Headrick Family Chair of the Valve Science Center for the Minneapolis Heart Institute Foundation and director of the Center for Valve and Structural Heart Disease for the Minneapolis Heart Institute at Abbott Northwestern Hospital and co-principal investigator of the TRILUMINATE Pivotal trial. “With TriClip, physicians can offer patients a therapy option backed by excellent safety and effectiveness to help restore tricuspid native valve performance without subjecting them to high-risk open-heart surgery that may not be feasible for individuals with TR who are generally older and sicker.”

The tricuspid valve controls blood as it flows from the heart’s right atrium to the right ventricle. TR occurs when the valve doesn’t close properly, causing a leak and allowing blood to flow backward in the heart. TR can force the heart to work harder, causing debilitating symptoms such as fatigue and shortness of breath. When left untreated, TR can lead to atrial fibrillation, heart failure, and ultimately, death. For those who continue to have symptoms or persistent TR despite treatment with medical therapy and are not considered good candidates for surgery, TriClip represents an option that can improve a person’s quality of life.

Delivered through a vein in the leg, TriClip’s TEER technology works by clipping together a portion of the leaflets – or flaps of tissue – to repair the tricuspid valve and help blood flow in the right direction without the need for open-heart surgery. On average, people who receive TriClip only need one day in the hospital before they recover and can return home.

As part of its approval process, the FDA reviewed findings from the TRILUMINATE Pivotal trial, the world’s first randomized, controlled clinical study to evaluate the safety and effectiveness of the TriClip system compared to medical therapy in people with severe TR who are at intermediate or greater risk for open-heart surgery. In the study, 90% of patients who received the TriClip system experienced a marked improvement in their TR grade, reducing from severe or higher to moderate or less at 30 days – a reduction that was sustained at one year. The trial also demonstrated a highly favorable safety profile, with 98% of patients being free of major adverse events through 30 days, and a significant improvement in quality of life.

“This approval helps address a treatment gap for people with tricuspid regurgitation who previously had few options to treat a disease that adversely impacted their daily lives and could lead to other deadly conditions,” said Sandra Lesenfants, senior vice president of Abbott’s structural heart business. “With the addition of TriClip to our broad structural heart therapy offerings in the U.S., we are continuing to bring meaningful, life-enhancing benefits to patients with cardiovascular conditions.”

TriClip leverages the same clip-based technology as Abbott’s MitraClip device – which has treated more than 200,000 people with leaky mitral valves (mitral regurgitation) – but was specifically designed to treat the tricuspid valve’s complex anatomy.

TriClip has been approved for use in more than 50 countries, including in Europe and Canada, since its initial CE Mark approval in 2020. The device has already been used to treat more than 10,000 people with TR.

In addition to TriClip, the company’s minimally invasive therapies include first-of-its-kind technologies MitraClip and Amplatzer Piccolo Occluder (to close a hole in the heart of babies), as well as the Navitor transcatheter aortic valve implantation system (to treat aortic stenosis). 

Read also: Abbott gets USFDA clearance for whole blood rapid test to help with assessment of concussion at patient bedside

This DNB and DRNB Final Theory Examination for May 2024 will be conducted on 15, 16, 17 and 18 May 2024 at various examination centres across the country. Candidates can submit applications for the said examination online from 2 April 2024 (3 PM onwards) to 22 April 2024 (11:55 PM onwards).

HOW TO FILL APPLICATION FORM

1 Applicants have to register themselves online on the Online Exit Examination Portal (OEEP) to submit the DNB/DRNB Final Examination application to the National Board of Examination in Medical Sciences. The online exit examination portal can be accessed through the official website of NBEMS.

2 After successful registration and application submission, candidates can log in to their OEEP account to check the status of the online application submitted for DNB/DRNB final examinations, any deficiencies will inform them about downloading the admit card.

3 Application for DNB/DRNB Final Theory Examination- May 2024 can be submitted online only through the official website of the National Board of Examination in Medical Sciences. There is no other mode of submission of application and if it is submitted through any other mode it will be summarily rejected.

4 Following steps shall be required to be completed in sequence for application submission to NBEMS:

A. Register a User.

B. Complete the Application form, Examination City Selection and Upload Prescribed Documents.

C. Pay Examination Fee.

5 The applicant candidate shall register a username and create his/her online profile with the Online Exit Examinations Portal. On successful creation of the candidate profile, the applicant shall be required to complete the DNB/DrNB Final Examinations application form, pay the prescribed examination fee and upload the prescribed documents online. Candidates shall be able to preview the application form for any corrections required before final submission.

6 The applicant candidate may save and print the application form submitted online for future reference. There is no requirement to submit the hard copy of the application form and documents uploaded to NBEMS.

TIME TABLE OF DNB FINAL (BROAD SPECIALITY)

TIME TABLE OF DrNB FINAL (SUPER SPECIALITY)

TIME TABLE OF SUPER SPECIALITY DIRECT 6 YEARS COURSE-PART-I

EXAMINATION FEE

ELIGIBILITY CRITERIA OF DNB BROAD SPECIALITY

1 Candidates who have undergone training as a DNB trainee at any of the National Board of Examinations in Medical Sciences accredited institutes after having registered with NBEMS as a DNB trainee and are completing their prescribed training as a DNB trainee by the date mentioned below & on submission of a certificate to this effect, can undertake the DNB Final Examination in the same speciality.

2 Submission of Training Completion Certificate indicating details of leave taken during DNB training for DNB trainees is an essential pre-requisite. In case the candidate does not submit the training Completion certificate along with the application form, his/her application shall be rejected and fees forfeited.

3 Request for extension in cutoff date for completion of training for eligibility determination for DNB final Examination shall not be considered.

4 Candidates who have completed their DNB training while applying for the DNB Final Examination shall be required to submit a Final Training Completion Certificate (FTCC).

5 Candidates whose DNB training is ongoing while applying for the DNB Final Examination shall be required to submit a Provisional Training Completion Certificate (PTCC). The PTCC must confirm that the candidate would be able to complete his/her training by the prescribed cut-off after taking into consideration all leave taken vis-a-vis the maximum permissible leave as per NBEMS leave rules and the required period of extension, if any. Such candidates are required to submit a Final Training Completion Certificate (FTCC) as per the format in Annexure-IV immediately upon completion of their training. Such candidates shall be provisionally allowed to appear for the DNB Final Examination subject to completion of their DNB training by the prescribed cut-off date.

6 Candidates who submit their Provisional TCC with correct leave details projecting their training completion on/before the prescribed cut-off date for the examination, happen to avail more leave after applying for the examination due to some unforeseen reasons which might take their training beyond the prescribed cutoff date, shall NOT be declared INELIGIBLE for the examination.

7 If such a candidate qualifies for the theory and practical examination, his/her Provisional Pass Certificate shall only be issued on completion of his/her DNB training and submission of Final TCC to this effect.

8 If such a candidate qualifies theory examination but fails to qualify for the practical examination, his/her candidature for the theory examination shall remain valid and he/she shall be allowed to appear in the next remaining attempt(s) of the practical examination, provided that he/she completes his/her DNB training before the next attempt of practical examination.

9 However, candidates who at any stage are found to have misrepresented/failed to disclose the complete details of leave taken by them, in their Provisional TCC, shall be declared INELIGIBLE on failing to complete their training on/before the prescribed cut-off date for the examination. Candidature of such candidates for the DNB Final Examination shall stand cancelled and the result, if any declared, shall be treated as null and void.

10 In terms of the NBEMS notice dated 26th November 2019, appearance in the minimum required numbers of Formative Assessment Tests (FATs) during the DNB/DrNB training shall be mandatory towards eligibility for appearing in DNB/DrNB Final Examinations. This compulsory participation in FATs shall apply to candidates who have joined their training in or after the July 2019 admission session.

ELIGIBILITY CRITERIA OF DrNB SUPER SPECIALITY

1 Candidates who have undergone training as a DrNB trainee at any of the National Board of Examinations in Medical Sciences accredited institutes after having registered with NBEMS as a DrNB trainee and are completing their prescribed training as a DrNB trainee by the date mentioned below, & on submission of a certificate to this effect, can undertake the DrNB Final Examination in the same speciality.

2 Submission of Training Completion Certificate indicating details of leave taken during DrNB training for DrNB trainees is an essential pre-requisite. In case the candidate does not submit the training Completion certificate along with the application form, his/her application shall be rejected and fees forfeited.

3 Request for extension in cutoff date for completion of training for eligibility determination for DrNB final Examination shall not be considered.

4 Candidates who have completed their DrNB training while applying for the DrNB Final Examination shall be required to submit a Final Training Completion Certificate (FTCC).

5 Candidates whose DrNB training is ongoing while applying for the DrNB Final Examination shall be required to submit a Provisional Training Completion Certificate (PTCC). The PTCC must confirm that the candidate would be able to complete his/her training by the prescribed cut-off after taking into consideration all leave taken vis-a-vis the maximum permissible leave as per NBEMS leave rules and the required period of extension, if any. Such candidates are required to submit a Final Training Completion Certificate (FTCC) as per the format in Annexure-IV immediately upon completion of their training. Such candidates shall be provisionally allowed to appear for the DrNB Final Examination subject to completion of their DrNB training by the prescribed cut-off date.

6 Candidates who submit their Provisional TCC with correct leave details projecting their training completion on/before the prescribed cut-off date for the examination, happen to avail more leave after applying for the examination due to some unforeseen reasons which might take their training beyond the prescribed cutoff date, shall NOT be declared INELIGIBLE for the examination.

7 If such a candidate qualifies for the theory and practical examination, his/her Provisional Pass Certificate shall only be issued on completion of his/her DrNB training and submission of Final TCC to this effect.

8 If such a candidate qualifies theory examination but fails to qualify for the practical examination, his/her candidature for the theory examination shall remain valid and he/she shall be allowed to appear in the next remaining attempt(s) of the practical examination, provided that he/she completes his/her DrNB training before the next attempt of practical examination.

9 However, candidates who at any stage are found to have misrepresented/failed to disclose the complete details of leave taken by them, in their Provisional TCC, shall be declared INELIGIBLE on failing to complete their training on/before the prescribed cut-off date for the examination. Candidature of such candidates for the DrNB Final Examination shall stand cancelled and the result, if any is declared, shall be treated as null and void.

10 In terms of the NBEMS notice dated 26th November 2019, appearance in a minimum required number of Formative Assessment Tests (FATs) during the DNB/DrNB training shall be mandatory towards eligibility for appearing in DNB/DrNB Final Examinations. This compulsory participation in FATs shall apply to candidates who have joined their training in or after the July 2019 admission session.

EXAMINATION SCHEME OF DNB BROAD SPECIALITY

1 The theory examination comprises of four papers, a maximum mark of 100 each.

2 There are 10 short notes of 10 marks each, in each of the papers.

3 The number of short notes and their respective marks weightage may vary in some subjects/some papers.

4 Maximum time permitted is 3 hours.

5 Candidate must score at least 200/400 in the aggregate of 4 papers to qualify the theory examination. Grace marks of up to 2% of maximum marks i.e. 8/400 shall be given only to the candidates falling in the zone of consideration i.e. securing between 192-199 marks out of 400. 6 Only those candidates who have qualified the theory examination are permitted to take the practical examination.

EXAMINATION SCHEME OF DrNB SUPER SPECIALITY

1 Maximum Marks: 300

2 The theory exam comprises of three question papers.

3 There are 10 short notes of 10 marks each in the question paper.

4 The number of short notes and their respective marks weightage may vary in some subjects/some papers.

5 Maximum time permitted is 3 hours for each question paper.

6 Candidate must score at least 50% of maximum marks to qualify the theory exam i.e. candidate scoring 150 or more marks out of 300 shall be declared ‘pass’ in the theory examination.

7 Candidate must score at least 150/300 in the aggregate of 3 papers to qualify the theory examination. Grace marks of up to 2% of maximum marks i.e. 6/300 shall be given only to the candidates falling in the zone of consideration i.e. securing between 144-149 marks out of 300. 8 Candidates who have qualified the theory examination are permitted to take up the practical examination.

To view the information Bulletin, click the link below

A study was done to investigate the associations of excessive dietary sodium with all-cause and cause-specific mortality among predominantly low-income Black and White Americans. This cohort study included participants aged 40 to 79 years from the Southern Community Cohort Study who were recruited at Community Health Centers in 12 southeastern states from 2002 to 2009. Analyses were conducted between March 2022 and June 2023. Dietary sodium intake was assessed using a validated food frequency questionnaire at baseline. Multivariable-adjusted Cox regression was used to estimate hazard ratios (HRs) and 95% CIs for mortality outcomes (all-cause, cardiovascular disease [CVD], coronary heart disease [CHD], stroke, heart failure, cancer, and other) associated with sodium intake. Nonlinear associations and population-attributable risk (PAR) of the mortality burden associated with excess sodium were further assessed. RESULTS: Among the 64 329 participants, 46 185 (71.8%) were Black, 18 144 (28.2%) were White, and 39 155 (60.9%) were female. The mean (SD) age at study enrollment was 51.3 (8.6) years for Black participants and 53.3 (9.3) years for White counterparts. Mean (SD) dietary sodium intake was 4512 (2632) mg/d in Black individuals and 4041 (2227) mg/d in White individuals; 37 482 Black individuals (81.2%) and 14 431 White individuals (79.5%) exceeded the current dietary recommendations of 2300 mg/d. During a median (IQR) follow-up of 13.8 (11.3-15.8) years, 17 811 deaths were documented, including 5701 from CVD. After adjustment for potential confounders, in Black individuals, HRs per 1000-mg increase in daily sodium intake were 1.07 (95% CI, 1.03-1.10) and 1.08 (95% CI, 1.02-1.14) for deaths from total CVD and CHD, respectively; while in White individuals, the corresponding HRs were 1.08 (95% CI, 1.02-1.14) and 1.13 (95% CI, 1.03-1.23). No significant associations were found for cancer mortality. PAR estimates suggest that sodium intake above the recommended threshold may account for 10% of total CVD, 13% of CHD, and 30% of heart failure deaths in this low-income southern population. In this cohort study of 64 329 low-income Americans, nearly 80% of study participants consumed sodium exceeding the current recommended daily amount, which was associated with 10% to 30% of CVD mortality. Public health programs targeted to reduce sodium intake among this underserved population may be beneficial.

Reference:

Yoon H, Cai Q, Yang JJ, et al. Sodium Intake and Cause-Specific Mortality Among Predominantly Low-Income Black and White US Residents. JAMA Netw Open. 2024;7(3):e243802. doi:10.1001/jamanetworkopen.2024.3802

Keywords:

Sodium intake, raises, mortality risks, vulnerable populations, Yoon H, Cai Q, Yang JJ,JAMA

Guidelines recommend withholding antibiotics in asymptomatic bacteriuria (ASB), including among patients with altered mental status (AMS) and no systemic signs of infection. However, ASB treatment remains common. A study was done to determine prevalence and factors associated with bacteremia from a presumed urinary source in inpatients with ASB with or without AMS and estimate antibiotics avoided if a 2% risk of bacteremia were used as a threshold to prompt empiric antibiotic treatment of ASB. This cohort study assessed patients hospitalized to nonintensive care with ASB (no immune compromise or concomitant infections) in 68 Michigan hospitals from July 1, 2017, to June 30, 2022. Data were analyzed from August 2022 to January 2023. The primary outcome was prevalence of bacteremia from a presumed urinary source (ie, positive blood culture with matching organisms within 3 days of urine culture). To determine factors associated with bacteremia, we used multivariable logistic regression models. We estimated each patient’s risk of bacteremia and determined what percentage of patients empirically treated with antibiotics had less than 2% estimated risk of bacteremia. Results: Of 11 590 hospitalized patients with ASB (median [IQR] age, 78.2 [67.7-86.6] years; 8595 female patients [74.2%]; 2235 African American or Black patients [19.3%], 184 Hispanic patients [1.6%], and 8897 White patients [76.8%]), 8364 (72.2%) received antimicrobial treatment for UTI, and 161 (1.4%) had bacteremia from a presumed urinary source. Only 17 of 2126 patients with AMS but no systemic signs of infection (0.7%) developed bacteremia. On multivariable analysis, male sex (adjusted odds ratio [aOR], 1.45; 95% CI, 1.02-2.05), hypotension (aOR, 1.86; 95% CI, 1.18-2.93), 2 or more systemic inflammatory response criteria (aOR, 1.72; 95% CI, 1.21-2.46), urinary retention (aOR, 1.87; 95% CI, 1.18-2.96), fatigue (aOR, 1.53; 95% CI, 1.08-2.17), log of serum leukocytosis (aOR, 3.38; 95% CI, 2.48-4.61), and pyuria (aOR, 3.31; 95% CI, 2.10-5.21) were associated with bacteremia. No single factor was associated with more than 2% risk of bacteremia. If 2% or higher risk of bacteremia were used as a cutoff for empiric antibiotics, antibiotic exposure would have been avoided in 78.4% (6323 of 8064) of empirically treated patients with low risk of bacteremia. In patients with ASB, bacteremia from a presumed urinary source was rare, occurring in less than 1% of patients with AMS. A personalized, risk-based approach to empiric therapy could decrease unnecessary ASB treatment.

Reference:

Advani SD, Ratz D, Horowitz JK, et al. Bacteremia From a Presumed Urinary Source in Hospitalized Adults With Asymptomatic Bacteriuria. JAMA Netw Open. 2024;7(3):e242283. doi:10.1001/jamanetworkopen.2024.2283

Keywords:

Bacteremia, urinary source, hospitalized patients, asymptomatic, bacteriuria, Advani SD, Ratz D, Horowitz JK