Microwave Ablation promising treatment alternative for patients with multifocal papillary thyroid carcinoma: Study

A recent study published in the Radiology journal illuminated the effectiveness of Microwave Ablation (MWA) as a promising treatment alternative for patients with multifocal papillary thyroid carcinoma (PTC). PTC is traditionally managed with surgical resection (SR) which often leads to a loss of thyroid function that raises concern about the quality of life of the patients post-treatment. This study compared the outcomes of MWA with SR and suggested that MWA preserves thyroid function and presents a minimally invasive option for patients.

This study was conducted across 10 medical centers from May 2015 to December 2021 and included a total of 775 patients who were diagnosed with T1N0M0 multifocal PTC through preoperative ultrasonography (US). This research utilized the propensity score matching and meticulously compared the progression-free survival (PFS) rates and complication rates between the patients who underwent MWA and the individuals who were subjected to SR.

The outcomes were observed over a median span of 20 to 26 months which revealed compelling evidence in favor of MWA. The procedure demonstrated significant advantages that included less blood loss, shorter incision lengths and reduced durations of both the procedure itself and hospital stays that highlighted its efficiency and patient-friendly nature. Also, the study found no significant difference in overall and 1-, 3- and 5-year PFS rates between the two groups that indicated the efficacy of MWA in controlling the disease progression is comparable to that of the traditional surgical approach. The results found low complication rates associated with MWA. SR resulted in permanent hoarseness and hypoparathyroidism in a small percentage of patients, whereas, MWA showed a relatively safe profile with low postoperative complications.

The conclusion of this extensive comparison highlights the potential of MWA as a critical treatment option for selected patients with multifocal T1N0M0 PTC. Overall, this study offers a less invasive treatment pathway that paves the way for improved quality of life and disease management strategies. Further research and comparative analyses is imperative which will solidify the role of MWA in the comprehensive management of thyroid cancer for the patients who face the bad prospect of thyroid surgery.

Source:

Zhao, Z.-L., Wang, S.-R., Dong, G., Liu, Y., He, J.-F., Shi, L.-L., Guo, J.-Q., Wang, Z.-H., Cong, Z.-B., Liu, L.-H., Yang, B.-B., Qu, C.-P., Niu, W.-Q., Wei, Y., Peng, L.-L., Li, Y., Lu, N.-C., Wu, J., & Yu, M.-A. (2024). Microwave Ablation versus Surgical Resection for US-detected Multifocal T1N0M0 Papillary Thyroid Carcinoma: A 10-Center Study. In Radiology (Vol. 311, Issue 1). Radiological Society of North America (RSNA). https://doi.org/10.1148/radiol.230459

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Preventive PCI shows clinical benefit for Vulnerable non-flow-limiting Coronary Plaque in PREVENT trial

South Korea: Preventive percutaneous coronary intervention (PCI) reduces major adverse cardiac events arising from high-risk vulnerable plaques, compared with optimal medical therapy alone in patients with non-flow-limiting vulnerable coronary plaques, PREVENT trial has shown.

“Focal preventive PCI resulted in a large reduction in target vessel failure at two years (0.4% vs 3.4%; HR 0.11) — the benefit persisting out to 7 years (6.5% vs 9.4%; HR 0.54), compared with standard therapy alone,” the researchers reported that the American College of Cardiology (ACC) meeting. The findings were subsequently published in The Lancet.

Target vessel failure was defined as a composite of target vessel myocardial infarction (MI), cardiac death, ischemia-driven target vessel revascularization, and hospitalization for unstable or progressive angina — the benefit of PCI was driven by the latter two endpoint components.

The study stated, “Given that PREVENT is the first large trial to show the potential effect of the focal treatment for vulnerable plaques, these findings support consideration to expand indications for PCI to include non-flow-limiting, high-risk vulnerable plaques.”

Sudden cardiac death and acute coronary syndrome are often caused by rupture and thrombosis of lipid-rich atherosclerotic coronary plaques (known as vulnerable plaques), many of which are non-flow-limiting. The effectiveness and safety of focal preventive therapy with PCI of vulnerable plaques in reducing adverse cardiac events are unknown.

To fill this knowledge gap, Prof Seung-Jung Park, University of Ulsan College of Medicine, Seoul, South Korea, and colleagues aimed to assess whether preventive PCI of non-flow-limiting vulnerable plaques improves clinical outcomes versus optimal medical therapy alone.

For this purpose, the researchers conducted a PREVENT trial at 15 research hospitals in four countries. Patients aged 18 years or older with non-flow-limiting (fractional flow reserve >0·80) vulnerable coronary plaques identified by intracoronary imaging were included. They were randomly assigned in a 1:1 ratio to either PCI plus optimal medical therapy or optimal medical therapy alone. In all enrolled patients, follow-up continued annually until the last enrolled patient reached two years after randomization.

The study’s primary outcome was a composite of death from cardiac causes, ischemia-driven target-vessel revascularization, target-vessel myocardial infarction, or hospitalization for unstable or progressive angina.

The study led to the following findings:

· 5627 patients were screened for eligibility between 2015 and 2021, 1606 of whom were enrolled and randomly assigned to PCI (n=803) or optimal medical therapy alone (n=803). 73% of patients were men.

· Two-year follow-up for the primary outcome assessment was completed in 97% of patients (percutaneous coronary intervention group n=780; optimal medical therapy group n=776).

· At 2 years, the primary outcome occurred in 0·4% of patients in the percutaneous coronary intervention group and 3·4% of patients in the medical therapy group.

· The effect of preventive percutaneous coronary intervention was directionally consistent for each component of the primary composite outcome.

· Serious clinical or adverse events did not differ between the percutaneous coronary intervention group and the medical therapy group: at two years, 0·5% versus 1·3% patients died, and 1·1% versus 1·7% patients had a myocardial infarction.

The researchers of the PREVENT trial acknowledged that their open-label study design left room for a placebo effect and ascertainment bias. Lower-than-expected event rates also limited them.

They pointed to multiple ongoing randomized trials — INTERCLIMA, COMBINE-INTERVENE, FAVOR V AMI, and VULNERABLE– for more answers about preventive PCI on vulnerable plaques.

Reference:

DOI: https://doi.org/10.1016/S01406736(24)00413-6

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Preventive ablation of ventricular tachycardia may effectively prevent ICD shocks and hospitalization: Study

The first randomised trial to investigate preventive ablation of a potential arrhythmogenic substrate associated with coronary chronic total occlusion (CTO) in patients at high risk of ventricular arrhythmias (VAs) reduces the risk of appropriate implantable cardioverter-defibrillator (ICD) therapy and unplanned hospitalisation in patients with no previously recorded VAs. The late-breaking science is presented at EHRA 2024, a scientific congress of the European Society of Cardiology (ESC).

Principal investigator Dr. David Zizek of the University Medical Centre Ljubljana, Slovenia said: “In everyday clinical practice, ventricular tachycardia (VT) ablation is still often regarded as a last resort in the management of patients with ischaemic cardiomyopathy. We hypothesised that ablation early in the course of the disease, when patients have a lower burden of comorbidities, might be associated with fewer periprocedural complications and improved clinical outcomes compared to withholding the procedure until several ICD shocks have occurred. Our study shows that a primary prevention ablation strategy can be a safe and effective treatment option to prevent ICD interventions and arrhythmia-related hospitalisations.”

ICD therapy is recommended for primary prevention of sudden cardiac death in ischaemic cardiomyopathy patients with reduced ejection fraction despite optimal medical treatment. Approximately one in three ischaemic cardiomyopathy patients with previous myocardial infarction have infarct-related coronary CTO. Infarct-related CTO is a strong and independent predictor of VAs in ischaemic patients with a primary prevention ICD. Appropriate ICD shocks are live-saving, but are linked with reduced quality of life, physiological distress, pain, heart failure hospitalisation, and cardiovascular death. However, the optimal time to perform VT ablation is uncertain.

The PREVENTIVE VT trial investigated the impact of preventive VT ablation on ICD interventions in patients with ischaemic cardiomyopathy and infarct-related coronary CTO. The trial was conducted at four centres in Slovenia between September 2017 and January 2024. It enrolled patients with ischaemic cardiomyopathy, reduced ejection fraction (≤40%), angiographically proven coronary CTO associated with previous myocardial infarction, and no previously documented sustained VAs. In addition, patients were not eligible for revascularisation, were on optimal medical therapy, and had an indication for primary prevention ICD implantation.

Participants were randomly assigned 1:1 to preventive substrate ablation before ICD implantation (preventive ablation group) or ICD implantation only (standard therapy group). The purpose of ablation was to abolish abnormal ventricular electrograms within the scar and its border and achieve non-inducibility of monomorphic VT after a uniform stimulation protocol. High-density voltage mapping with a 3D electroanatomical mapping system was used to delineate the infarct-related CTO and the border zone, and scar homogenisation was performed. Primary prevention ICD settings for arrhythmia detection and therapy were recommended for both groups.

The primary outcome was a composite of appropriate ICD therapy or unplanned hospital admission for symptomatic VAs. Secondary outcomes included the incidence of appropriate ICD therapies, unplanned VA-related hospitalisation, cardiac hospitalisation (due to VA or worsening heart failure), electrical storm, and cardiovascular mortality.

A total of 60 patients were enrolled (30 in each group). The average age was 67.5 ± 8.1 years and 91.7% were male. In the preventive ablation group, total elimination of abnormal electrograms was achieved in 26 (86.7%) patients and VT was not inducible in 27 (90%) patients. There were 2 (6.6%) major complications associated with the ablation procedure.

During a mean follow-up of 44.73 months, the primary endpoint occurred in 5 (16.7%) patients undergoing ablation and 13 (43.3%) patients receiving an ICD only (multivariate hazard ratio [HR] 0.32, 95% confidence interval [CI] 0.11-0.91; p=0.032). Univariate analyses showed that patients in the ablation group had fewer appropriate ICD therapies (17% vs. 40%; HR 0.37, 95% CI 0.13-1.05, p=0.051), unplanned VA-related hospitalisations (0% vs. 30%; p=0.001), and cardiac hospitalisations (13% vs. 53%; HR 0.21, 95% CI 0.07-0.63, p=0.002). While preventive ablation reduced the number of electrical storms (0% vs. 20%; p=0.01), it had no significant impact on cardiovascular mortality (13.3% vs. 26.7%; HR 0.41, 95% CI 0.12-1.38, p=0.139). Multivariate analyses were performed when events were recorded in both arms and yielded similar results.

Dr. Zizek said: “Our study also highlights the importance of identifying ischaemic cardiomyopathy patients with a high risk of VAs in whom substrate ablation might prevent arrhythmias and consequent debilitating ICD shocks, while outweighing the potential for procedural complications.”

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Vitamin D concentration above 30 ng/mL may protect against gestational diabetes in twin pregnancy: Study

China: A recent study revealed a significantly lowered risk of gestational diabetes mellitus (GDM) in twin pregnant women with vitamin D concentrations ≥ 30 ng/mL in the second trimester. The findings were published online in Nutrition Journal on April 10, 2024.

Gestational diabetes is a common complication of pregnancy, with significant short-term and long-term effects for both mothers and their offspring. Previous studies have shown the potential benefits of vitamin D in reducing GDM risk, yet not much is known about this association in twin pregnancies. To fill this knowledge gap, Li Wen, Chongqing Health Center for Women and Children, Chongqing, China, and colleagues aimed to investigate maternal vitamin D status in the second trimester and determine its association with the risk of GDM in twin pregnancies.

For this purpose, they conducted a prospective cohort study based on Chongqing Longitudinal Twin Study (LoTiS) data. To measure 25(OH)D concentrations, peripheral blood serum was collected from the mothers in the second trimester. Gestational diabetes was diagnosed at 23–26 weeks of gestation using a 75-g 2-h oral glucose tolerance test. The correlations between vitamin D status and GD risk were also examined.

The study revealed the following findings:

· Of the total participants, 29.9% of women were diagnosed with GDM.

· The mean serum 25(OH)D concentration in the second trimester was 31.1 ± 11.2 ng/mL, and the rate of vitamin D insufficiency and deficiency were 23.5% and 18.7%, respectively.

· Compared to women with a 25(OH)D concentration < 30 ng/mL, those with a 25(OH)D concentration ≥ 30 ng/mL had a significantly lower risk of GDM (RR 0.61), especially those who were overweight before pregnancy (RR 0.32).

· The restricted cubic splines model showed an inverted J-shaped relationship between vitamin D concentrations and GDM risk.

In conclusion, the risk of GDM was significantly reduced in those with vitamin D levels ≥ 30 ng/mL in the second trimester in twin pregnant women with vitamin D concentrations < 30 ng/mL in the second trimester. The researchers found a nonlinear association between vitamin D concentrations and GDM incidence, with 30 ng/mL considered as the cutoff for the vitamin D concentration that could significantly reduce GDM risk in twin pregnancies.

“There is a need for further multicenter research to provide more evidence elucidating the relationship between vitamin D and GDM in twin pregnancies,” the researchers concluded.

One limitation was the study’s single-center design, which limits the findings generalizability of the findings. Another limitation was the lack of accurate data on vitamin D supplementation during the second trimester.

Reference:

Li, Dy., Wang, L., Li, L. et al. Maternal vitamin D status and risk of gestational diabetes mellitus in twin pregnancies: a longitudinal twin pregnancies birth cohort study. Nutr J 23, 41 (2024). https://doi.org/10.1186/s12937-024-00944-2

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Vaccinations Do Not Increase Graft Rejection Risk in Corneal Transplant Recipients: Study

A comprehensive study published in the American Journal of Ophthalmology suggest that vaccinations do not significantly increase the risk of corneal graft rejection among transplant recipients. This research from Kaiser Permanente Southern California spanned from January 2008 to August 2022. This study by Jennifer H. Ku involved the examination of the health records of a total of 601 corneal transplant recipients who experienced graft rejection and matched them with 1,803 controls.

Corneal transplantation (also known as keratoplasty) is a surgical procedure that replaces a damaged or diseased cornea with healthy donor tissue. One of the main complications following this surgery is the graft rejection. And so this study evaluated whether receiving vaccinations within 12 weeks prior to the index date of graft rejection could be a contributing factor to this major complication.

The key findings of the study were;

Approximately 23% of the cases and 22% of the controls received one or more vaccinations within the 12-week period leading up to the index date. The adjusted odds ratios (aORs) were calculated to measure the association between receiving vaccinations and experiencing a graft rejection. The results showed that the overall risk did not increase significantly after vaccination, with an aOR of 1.17 (95% CI: 0.91, 1.50).

A more detailed analysis revealed that the aOR was 1.09 for individuals who received one vaccination, 1.53 for those who received two vaccinations, and 1.79 for those who received three or more. Additionally, the study evaluated the impact of different types of vaccines, including mRNA vaccines and adjuvanted or high-dose vaccines. The aOR for mRNA vaccines was 1.60, while for adjuvanted or high-dose vaccines the aOR was 1.19.

These findings are crucial as they suggest that completing recommended vaccinations poses no significant risk to corneal graft viability. This research supports the ongoing vaccination of corneal transplant recipients. We believe that maintaining vaccination schedules is crucial for this population, without increasing the risk of corneal graft rejection. The outcomes of this study provide critical data that can help guide clinical decisions regarding the vaccination of corneal transplant recipients. Overall, these results reassure that adhering to recommended vaccination schedules is a safe practice which should not be deferred.

Reference:

KU, J. H., NANJI, A. A., TUBERT, J. E., JOE, C., SRIKUMARAN, D., WINTHROP, K. L., BRUNTON, A. E., FLOREA, A., FRAUNFELDER, F., TSENG, T., & LUO, Y. (2024). Risk of Corneal Graft Rejection and Vaccination: A Matched Case-Control Study From a United States Integrated Health Care System. In American Journal of Ophthalmology (Vol. 263, pp. 133–140). Elsevier BV. https://doi.org/10.1016/j.ajo.2024.02.015

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Submit global regulatory status of Atezolizumab for IV, SC route: CDSCO Panel Tells Roche Products India

New Delhi: In response to the proposal presented by the drug major Roche Products India for granting permission to import and market Atezolizumab injection (1875mg/15ml vial) (Tecentriq) by new route of administration i.e., subcutaneous route, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to submit the global regulatory status of the drug Atezolizumab for IV and SC route of administration along with indication.

This came after the proposal of the firm has been re-deliberated for the grant of permission to import and market Atezolizumab injection (1875mg/15ml vial) (Tecentriq) by new route of administration i.e., subcutaneous route for indications of Atezolizumab injection approved for Intravenous (IV) route for sale or for distribution in India with local Phase III clinical trial waiver under unmet need in India and commitment to conduct Phase IV study.

Atezolizumab is a monoclonal antibody used to treat advanced or metastatic urothelial carcinoma with disease progression during or up to 12 months after platinum-containing chemotherapy. Atezolizumab injection is used alone to help prevent non-small cell lung cancer (NSCLC) from coming back in patients whose tumors have been removed by surgery and who have received other cancer medicines (eg, platinum). It is given to patients who have stage 2 to stage 3A NSCLC and whose tumors express PD-L1.

Inhibition of PD-L1 by atezolizumab can remove this inhibitor effect and thereby engender an anti-tumor response. It is one of several ways to block inhibitory signals related to T-cell activation, a more general strategy known as “immune checkpoint inhibition.”

At an earlier SEC meeting dated 09.01.2024, the drug major Roche Products India presented a proposal for granting permission to import and market Atezolizumab Injection (1875mg/15ml vial) (Tecentriq) by new route of administration i.e., Subcutaneous route for indications of Atezolizumab injection approved for Intravenous (IV) route for sale or distribution in India with local Phase III and Phase IV clinical trial waiver for under unmet need in India.

The committee noted that the i.v formulation of Atezolizumab was already available in the market and the formulation and dose of the proposed s.c route was different from the i.v route. Furthermore, the committee found that India was not part of the global clinical study conducted to establish safety and efficacy data for the new route of administration i.e. s.c route.

In line with the above observation, the expert panel opined the firm to conduct a Phase III study to establish the safety and efficacy of the product for the proposed SC route.

Now, in continuation with the above, at the recent SEC meeting dated 19.03.2024 and 20.03.2024, the proposal of the firm has been redeliberated.

After detailed deliberation, the committee recommended the following:

1. The firm should submit the global regulatory status of the drug for IV and SC route of administration along with indication.

2. The firm should clarify the reason for the withdrawal of indications by USFDA along with its current status.

Accordingly, the expert panel suggested that the firm should submit the above clarifications to CDSCO for further evaluation by the committee.

Also Read: Eli Lilly Gets CDSCO Panel Nod To Import, Market Anti-cancer Drug Selpercatinib

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Reconsider on lengthy declaration form for NMC inspections: Doctors urges NMC

Pointing out that the current declaration forms are difficult and time-consuming to fill, the doctors have urged the National Medical Commission (NMC) to reconsider the need for these extensive forms required to be filled by residents and faculty during NMC inspections.

As per the current rules, at the time of inspection by the Apex Medical Regulator, all the faculties and resident doctors are required to submit a declaration form for the purpose of verification.

For more information, click on the link below:

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NBE set to unveil NEET MDS 2024 individual scorecard

The National Board of Examinations In Medical Sciences, New Delhi, is set to unveil the NEET MDS 2024 Individual Scorecard today, April 12, 2024. Aspiring candidates can procure their NBEMS NEET MDS 2024 Individual Scorecard from the official websites https://natboard.edu.in/ and https://nbe.edu.in/. Accessing the scorecard necessitates entering the application number and date of birth.

Upon visiting the aforementioned websites, applicants should locate the link labeled “Download NEET MDS 2024 Result.” Subsequently, they must input their login credentials, comprising the application number and date of birth. The NEET MDS 2024 Scorecard will then be displayed on the screen.

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Health Bulletin 12/ April/ 2024

Here are the top health news for the day:

NEET MDS 2024 individual scorecard released today

The National Board of Examinations In Medical Sciences, New Delhi, is set to unveil the NEET MDS 2024 Individual Scorecard today, April 12, 2024. Aspiring candidates can procure their NBEMS NEET MDS 2024 Individual Scorecard from the official websites https://natboard.edu.in/ and https://nbe.edu.in/. Accessing the scorecard necessitates entering the application number and date of birth.

Upon visiting the aforementioned websites, applicants should locate the link labeled “Download NEET MDS 2024 Result.” Subsequently, they must input their login credentials, comprising the application number and date of birth. The NEET MDS 2024 Scorecard will then be displayed on the screen.


Doctors raise concerns over lengthy NMC inspection declaration Form

 Pointing out that the current declaration forms are difficult and time-consuming to fill, the doctors have urged the National Medical Commission (NMC) to reconsider the need for these extensive forms required to be filled by residents and faculty during NMC inspections.

As per the current rules, at the time of inspection by the Apex Medical Regulator, all the faculties and resident doctors are required to submit a declaration form for the purpose of verification.

For more information, click on the link below:

How many leaves allowed for PG medical students?
The National Medical Commission (NMC) has recently specified how many leaves a medico can take while pursuing PG medical courses.
According to a recent NMC notification, PG medical students are allowed “weekly one-day off (subject to exigencies of work). In addition, they are eligible for twenty days of Paid Casual Leave. Five days of Academic Leave per year, if availed by a student will be counted as duty. Thus, a student is entitled to 52 weekly offs and 20 Paid Casual Leave per year.”
For more information, click on the link below:

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Can normothermic regional perfusion increase the number of patients receiving lung transplants?

Re-perfusing the lungs of an organ donor with a technique called normothermic regional perfusion (TA-NRP) after the heart has irreversibly stopped beating could potentially increase the number of patients receiving lung transplants, according to researchers at the Annual Meeting and Scientific Sessions of the International Society for Heart and Lung Transplantation (ISHLT) in Prague.

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