Experimental drug Olezarsen may reduce hypertriglyceridemia in high-risk patients: NEJM

Hypertriglyceridemia, or high levels of lipids (fats) in the blood, increases the risk of heart attack, stroke and acute pancreatitis. Currently available medications, including statins, ezetimibe, fibrates and prescription omega 3 fatty acids, typically lower triglyceride levels by anywhere from below 10% to up to 40%. These therapies help, but they are not enough to prevent cardiovascular events in everyone.

An experimental treatment could further lower triglycerides in the blood, according to a placebo-controlled and double-blind trial led by researchers at Brigham and Women’s Hospital, a founding member of the Mass General Brigham healthcare system. Results were presented at the 2024 American College of Cardiology’s Annual Scientific Session & Expo and simultaneously published in the New England Journal of Medicine.

The trial randomized 154 adults on lipid-lowering therapy with moderate or severe hypertriglyceridemia to receive either 50mg olezarsen, 80mg olezarsen or placebo. Olezarsen is an antisense oligonucleotide that inhibits APOC3, a gene associated with higher levels of triglycerides, by targeting its mRNA. The subcutaneous medication was administered every four weeks, for a period of a year.

Olezarsen reduced triglyceride levels by 49% at the 50mg dose and 53% at the 80mg dose, compared with placebo. The experimental drug also reduced apolipoprotein B and non-HDL cholesterol, which are important in plaque formation, by 18 to 18.5% and 23% to 25%, respectively.

While larger and longer-term studies are needed to further assess the efficacy and safety of olezarsen in preventing heart attacks and strokes, the research opens up new avenues for improving the health of people with high cardiovascular risk. “These findings indicate that targeting APOC3 mRNA is a promising new pathway for lowering triglycerides and potentially reducing the risk of heart attack and stroke,” said corresponding author Brian Bergmark, MD, of the Division of Cardiovascular Medicine at Brigham and Women’s Hospital.

Reference:

Brian A. Bergmark, Nicholas A. Marston, ThoNew England Journal of Medicinemas A. Prohaska, Veronica J. Alexander,  André Zimerman, Filipe A. Moura, Sabina A. Murphy, Olezarsen for Hypertriglyceridemia in Patients at High Cardiovascular Risk, New England Journal of Medicine, DOI: 10.1056/NEJMoa2402309.

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Liver transplantation: Normothermic regional perfusion tied to better DCD liver allograft outcome, study reveals

USA: A recent study published in JAMA Surgery reports US liver transplant outcomes after normothermic regional perfusion (NRP) versus standard super rapid recovery.

The findings suggest that NRP improves controlled donation after circulatory death (DCD) liver allograft outcomes and holds the potential to increase DCD organ use.

“The multicenter cohort study comprisng136 livers recovered with super rapid recovery (SRR) and 106 livers recovered with NRP showed comparable patient and graft survival in liver transplant recipients of DCD donors recovered by NRP versus SRR, with reduced ischemic cholangiopathy rates in NRP recipients,” the researchers reported.

Normothermic regional perfusion is an emerging recovery modality for transplantable allografts from controlled donation after circulatory death (cDCD) donors. In the US, only 11.4% of liver recipients transplanted from a deceased donor receive a cDCD liver.

NRP holds the potential to safely expand the US donor pool with improved transplant outcomes versus standard super rapid recovery. Considering this, Aleah L. Brubaker, University of California San Diego, La Jolla, California, and colleagues aimed to assess outcomes of US liver transplants using controlled donation after circulatory death livers recovered with NRP versus standard SRR.

For this purpose, the researchers conducted a retrospective, observational cohort study to compare liver transplant outcomes from cDCD donors recovered by NRP versus SRR. They collated outcomes of cDCD liver transplants from 2017 to 2023 from 17 US transplant centers. The livers recovered by SRR and NRP (thoracoabdominal NRP [TA-NRP] and abdominal NRP [A-NRP]) were included.

Seven transplant centers used NRP, allowing liver allografts to be transplanted at 17 centers; 10 centers imported livers recovered via NRP from other centers.

The study’s primary outcome was ischemic cholangiopathy (IC). Secondary endpoints were early allograft dysfunction (EAD), primary nonfunction (PNF), posttransplant length of stay (LOS), biliary anastomotic strictures, and patient and graft survival.

The study included 242 cDCD livers: 136 recovered by SRR and 106 recovered by NRP (TA-NRP, 79 and A-NRP, 27). Median NRP and SRR donor age was 30.5 years and 36 years, respectively.

The findings of the study were as follows:

  • Median (IQR) posttransplant LOS was significantly shorter in the NRP cohort (7 days vs 10 days).
  • PNF occurred only in the SRR allografts group (n = 2). EAD was more common in the SRR cohort (56.1% versus 36.4%).
  • Biliary anastomotic strictures were increased 2.8-fold in SRR recipients (6.7% vs 22.4%).
  • Only SRR recipients had IC (9.0%); IC-free survival by Kaplan-Meier was significantly improved in NRP recipients.
  • Patient and graft survival were comparable between cohorts.

In conclusion, there was comparable patient and graft survival in liver transplant recipients of cDCD donors recovered by NRP vs SRR, with reduced rates of IC, EAD, and biliary complications in NRP recipients.

The feasibility of TA-NRP and A-NRP implementation across multiple US transplant centers supports increasing NRP adoption to improve organ use, risk of wait-list mortality, and access to transplants.

Reference:

Brubaker AL, Sellers MT, Abt PL, et al. US Liver Transplant Outcomes After Normothermic Regional Perfusion vs Standard Super Rapid Recovery. JAMA Surg. Published online April 03, 2024. doi:10.1001/jamasurg.2024.0520

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MRI imaging in prostate cancer screening reduces number of unnecessary prostate biopsies: JAMA

Austria: Findings from a recent meta-analysis published in JAMA Oncology support the integration of prostate magnetic resonance imaging (MRI) in prostate cancer (PCa) screening to improve the balance of patient harms and benefits.

The systematic review and meta-analysis of 80 114 screened men from 12 studies revealed that MRI-based screening is associated with a reduced number of unnecessary prostate biopsies and detection of clinically insignificant prostate cancer while maintaining the detection of clinically significant prostate cancer versus prostate-specific antigen–only strategies. To balance these benefits and risks, clinical practice guidelines recommend shared decision-making strategies to identify informed candidates who are most likely to benefit from early detection of prostate cancer.

Prostate MRI is increasingly integrated within the prostate cancer early detection pathway. Therefore, Tamás Fazekas, Medical University of Vienna, Vienna, Austria, and colleagues systematically evaluate the existing evidence regarding screening pathways incorporating MRI with targeted biopsy and assess their diagnostic value compared with PSA–based screening with systematic biopsy strategies.

For this purpose, the researchers searched the online databases through May 2023. Randomized clinical trials (RCTs) and prospective cohort studies were eligible if they reported data on prostate MRI’s diagnostic utility in the setting of PCa screening.

The researchers extracted data on biopsy indications, the number of screened individuals, clinically significant PCa (csPCa) defined as International Society of Urological Pathology (ISUP) grade 2 or higher, biopsies performed, and insignificant (ISUP1) prostate cancers detected.

The study’s primary outcome was the detection rate of csPCa. Secondary outcomes included biopsy indication rates, clinically insignificant PCa detection rates, and the positive predictive value for the detection of csPCa.

The MRI-based and PSA-only screening strategies were compared. Based on the timing of MRI (primary/sequential after a PSA test) and cutoff (Prostate Imaging Reporting and Data System [PI-RADS] score ≥3 or ≥4) for biopsy indication, separate analyses were performed.

Data were synthesized from 80 114 men from 12 studies. Based on the analyses, the researchers reported the following findings:

  • Compared with standard PSA-based screening, the MRI pathway (sequential screening, PI-RADS score ≥3 cutoffs for biopsy) was associated with higher odds of csPCa when test results were positive (OR, 4.15), insignificant cancers detected (OR, 0.34), and decreased odds of biopsies (OR, 0.28) without significant differences in the detection of csPCa (OR, 1.02).
  • Implementing a PI-RADS score of 4 or greater threshold for biopsy selection was associated with a further reduction in the odds of detecting insignificant PCa (OR, 0.23) and biopsies performed (OR, 0.19) without differences in csPCa detection (OR, 0.85).

In conclusion, integrating MRI in prostate cancer screening pathways is tied to a reduced number of unnecessary biopsies and overdiagnosis of insignificant PCa while maintaining csPCa detection as compared with PSA-only screening.

“Our results highlight the need to reassess our approach to population-based screening; however, further evaluation is required on the optimal setup of MRI and biopsy scheme in the screening process,” the researchers wrote.

Reference:

Fazekas T, Shim SR, Basile G, et al. Magnetic Resonance Imaging in Prostate Cancer Screening: A Systematic Review and Meta-Analysis. JAMA Oncol. Published online April 05, 2024. doi:10.1001/jamaoncol.2024.0734

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Cannabis use during pregnancy may increase risk of ADHD, autism and intellectual disability in children: Study

A new study presented at the European Psychiatric Association Congress 2024 reveals a significant association between prenatal cannabis use disorder (CUD) and an increased risk of neurodevelopmental disorders in offspring, including attention deficit hyperactivity disorder (ADHD), autism spectrum disorder (ASD), and intellectual disability (ID).

Cannabis remains by far the most consumed illicit drug in Europe. Around 1.3% of adults in the European Union (3.7 million people) are estimated to be daily or almost daily users of cannabis. Though males have a typically higher prevalence with regards to cannabis use, the latest statistics show that women are catching up with men in drug use, especially in the younger population. There is increasing concern around the increase in cannabis use observed in younger females in the EU, especially among pregnant and breastfeeding women. This concern is amplified by recent studies that have shown that the content of delta9-tetrahidrocannabinol (THC) is currently around 2-fold higher than it was 15-20 years ago, therefore increasing the risk of adverse effects for young women and their offspring following use when pregnant. Additionally, it has been noted that the prevalence of ADHD and ASD in children and adolescents is on the rise with estimates of 5.3% to 5.9% worldwide and 4.6% for Europe for ADHD and 1 in 2000 for ASD across the EU. 

This large-scale study, conducted by researchers at Curtin University in Australia, analysed data from over 222,000 mother-offspring pairs in New South Wales, Australia. The research team utilised an innovative approach, leveraging linked data from health registries, ensuring both the exposure (prenatal CUD) and outcomes (neurodevelopmental disorders) were confirmed using diagnostic tools based on the ICD-10-AM classification system.

Key findings from the study include:

  • Children born to mothers with prenatal CUD displayed a 98% increased risk of ADHD, a 94% increased risk of ASD, and a 46% increased risk of ID compared to offspring without such exposure.
  • The study also identified a significant interaction effect between prenatal CUD and maternal smoking. Children born to mothers with both prenatal CUD and a history of smoking during pregnancy exhibited an even higher risk of developing ADHD, ASD, and ID.
  • Additionally, the research found synergistic effects between prenatal CUD and other pregnancy complications, such as low birth weight and premature birth, further increasing the risk of neurodevelopmental disorders in offspring.

These findings highlight the potential long-term consequences of cannabis use during pregnancy and emphasise the importance of preventive strategies.

Abay Woday Tadesse, lead researcher of the study at the Curtin School of Population Health commented on the findings, stating “The increased risk of neurodevelopmental disorders in children of mothers diagnosed with prenatal cannabis use that we have observed in this study underscores the critical needs for preventive measures, including preconception counselling, to mitigate the potential adverse outcomes.”

Professor Rosa Alati, Head of the Curtin School of Population Health and senior author of the study, added “These findings highlight the need to increase awareness of the risks associated with cannabis use during pregnancy among women planning to become pregnant.”

“This study is unique because it utilises linked data with confirmed diagnoses, providing a more robust picture of the potential risks associated with prenatal cannabis use. The results underscore the need for public health education campaigns and clinical interventions to raise awareness about the potential risks of cannabis use during pregnancy and to support women in making informed decisions regarding their health and the well-being of their children,” explains Dr Julian Beezhold, the Secretary General of the European Psychiatric Association.

Reference:

Cannabis use during pregnancy linked to increased risk of ADHD, autism and intellectual disability in children, European Psychiatric Association, Meeting:32nd European Congress of Psychiatry.

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Plasma Aldosterone levels may not predict ICU mortality in patients treated for COVID-19: Study

Poland: Plasma aldosterone levels do not predict 28-day mortality in patients treated for COVID-19 in the ICU, a recent study published in Scientific Reports has revealed.

Other factors, including the patient’s age, C-reactive protein (CRP), or creatinine contribute to the prognosis and severity of the disease.

In this study, the researchers attempted to find an association between the serum aldosterone levels measured on days 1, 3, 5, and 7 and the overall survival in the intensive care unit (ICU) for 28 days. They found higher mean plasma aldosterone levels in the patients who did not survive for 28 days, however, the results were not statistically significant, suggesting that aldosterone is not associated with ICU mortality.

Aldosterone’s immunotropic effects might play a role in COVID-19, as SARS-CoV-2 reportedly uses angiotensin-converting enzyme 2 receptors as an entry point into cells. The function of aldosterone closely relates to its action on mineralocorticoid receptors in the kidneys; it increases the renal retention of sodium and the excretion of potassium, which raises blood pressure (BP). Despite several studies investigating the effect of Ang-II and its blockers on the course of COVID-19 infection, there is no clarity on the role of aldosterone.

Against the above background, Jarosław Janc, Hospital of the Ministry of the Interior and Administration, Wrocław, Poland, and colleagues aimed to assess the correlation of aldosterone, creatinine, urea, CRP, and procalcitonin (PCT) levels with 28 days of mortality in patients treated for COVID19 in an ICU.

For this purpose, the researchers conducted a cross-selection study comprising 115 adult patients. They were divided into two groups: those who died within 28 days (n = 82) and those who survived (n = 33).

The researchers performed a correlation of urea, aldosterone, PCT, and CRP levels with 28 days of mortality in patients treated for COVID-19. They also analyzed patient’s sex, age, scores from the SAPS II, APACHE II, and SOFA scales, and comorbidities like hypertension (HA), ischemic heart disease (IHD), and diabetes (DM).

The investigation employed univariate and multivariate Cox proportional hazard regression models to explore mortality-related factors.

The study led to the following findings:

  • The individuals who survived for 28 days were of significantly lower mean age and achieved notably lower scores on the APACHE II, SAPS II, and SOFA assessment scales.
  • Statistically significantly higher CRP levels were observed on days 3, 5, and 7 in individuals who survived for 28 days.
  • Creatinine levels in the same group were also statistically significantly lower on days 1, 3, and 5 than those of individuals who died within 28 days.
  • In the univariate analysis, variables with a p-value of less than 0.50 were included in the multivariate model.
  • Age, APACHE II, SAPS II, and SOFA demonstrated significance in univariate analysis and were considered to be associated with mortality.
  • The outcomes of the multivariate analysis indicated that age (HR = 1.03) served as a robust predictor of mortality in the entire study population.

In conclusion, the plasma aldosterone level is not associated with ICU mortality in COVID-19 patients. Other factors, including the age, CRP, and creatinine of the patients’ contribute to the severity and prognosis of the disease.

“More research is needed to reach a definite conclusion,” the researchers wrote.

Reference:

Janc, J., Janc, J. J., Suchański, M., Fidut, M., & Leśnik, P. (2024). Aldosterone levels do not predict 28-day mortality in patients treated for COVID-19 in the intensive care unit. Scientific Reports, 14(1), 1-8. https://doi.org/10.1038/s41598-024-58426-8

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Pilocarpine may prevent radiation-induced xerostomia in head and neck cancer patients: Study

Pilocarpine may prevent radiation-induced xerostomia in head and neck cancer patients suggests a study published in the Oral Diseases.

To assess long-term efficacy and side effects of pilocarpine on irradiated head and neck cancer (HNC) patients in both for prevention and treatment of radiation-induced xerostomia (RIX). Retrospective observational study was conducted. Eligibility criteria included irradiated HNC patients who received pilocarpine at least 12 weeks either for prevention (group A) or for treatment (group B) of radiation-induced xerostomia. They collected the documented Late Effect Normal Tissue Task Force-Subjective, Objective, Management, Analytics subjective/objective grades of radiation-induced xerostomia before (only group B) and the latest visit for pilocarpine prescription, dosage, side effects, duration of treatment, and the cause of discontinuation. Results: Between December 2007 and June 2022, 182 patients were enrolled including 95 patients (52%) in group A and 87 patients (48%) in group B. Group A patients reported grades 1, 2, 3, and 4 objective radiation-induced xerostomia in 0%, 7%, 93%, and 0%. Grade 1, 2, and 3 subjective radiation-induced xerostomia were 57%, 28%, and 15%. All patients in group B had grade 3 both objective/subjective radiation-induced xerostomia. The overall improvement of objective/subjective radiation-induced xerostomia was found in 40%/83%. Discontinuation was found in 51% of patients due to tolerable symptoms or deterioration of the patient’s status. Based on this retrospective analysis, long-term use of pilocarpine in irradiated HNC appears feasible for both the prevention and treatment of radiation-induced xerostomia.

Reference:

Kittichet, R., Chitapanarux, I., Kittidachanan, K., & Sripan, P. (2024). A real-life experience of long-term use of pilocarpine in irradiated head and neck cancer patients. Oral Diseases, 00, 1–8. https://doi.org/10.1111/odi.14905

Keywords:

Pilocarpine, prevent, radiation-induced, xerostomia, head and neck, cancer patients, Study, Kittichet, R., Chitapanarux, I., Kittidachanan, K., & Sripan, P, Oral Diseases

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Alternate day oral iron more effective than daily use among diabetes patients with anemia, suggests study

Alternate-day oral iron is more effective than daily use among diabetes patients with anaemia suggests a new study published in the Annals of Medicine and Surgery.

Iron deficiency anaemia (IDA) and diabetes mellitus (DM) are the most prevalent diseases, and diabetic patients are more prone to IDA. Therefore, the main aim of this study was to investigate the relationship between patients with diabetes and IDA about taking iron pills daily and every other day to reduce the effects related to it. Ninety-one participants were enrolled and randomly divided into two groups, with a final analysis cohort of 72 patients. The primary focus was on changes in serum Hb and Ferritin levels. The screening phase lasted 24 weeks, leading to 72 eligible participants meeting the criteria for entry into the study. Additionally, the study examined alternations in Hb and Hb A1C levels after treating patients with iron deficiency. The Hb and ferritin level contrasts between groups were not significant (P = 0.096 and P = 0.500, respectively). The relationship between Hb A1C and Hb levels before and after treatment was positive and significant (r 2 = 0.187). The results of the present study show that although the effectiveness of using oral iron supplements did not have a significant difference in terms of increasing haemoglobin and ferritin, the use of oral iron once every other day was more effective than the use of oral iron every day, and also in this study Like other studies, this result concluded that there is a negative correlation between Hb A1C and Hb, and to check the status of Hb A1C in diabetics, the level of Hb should be considered first.

Reference:

Taati B, Ganji R, Moradi L, Vosoughi T, Gisouei A. Therapeutic effect of ferrous sulfate in diabetic patients with iron deficiency anaemia: a randomised controlled trial. Ann Med Surg (Lond). 2024;86(4):1989-1996. Published 2024 Feb 15. doi:10.1097/MS9.0000000000001838

Keywords:

Alternate day , oral iron, effective, daily use, diabetes patients, anemia, study, Taati B, Ganji R, Moradi L, Vosoughi T, Gisouei A, Annals of Medicine and Surgery, diabetes, ferritin, haemoglobin, iron deficiency anaemia, Iron supplements

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Vitamin C Supplementation in Pregnancy Linked to Reduced Wheeze in Offspring: JAMA

Maternal smoking during pregnancy is known to have detrimental effects on offspring respiratory health, including an increased risk of wheeze. A recent secondary analysis of clinical trial data investigated the association between vitamin C supplementation during pregnancy and wheeze occurrence in children exposed to maternal smoking. This study was published in the JAMA Pediatrics journal. The study was conducted by McEvoy C. T. and colleagues.

Children exposed to maternal smoking during pregnancy face an elevated risk of respiratory issues, including wheeze, later in life. Vitamin C supplementation has shown promise in mitigating some of these adverse effects, possibly by improving airway function. However, the specific mechanisms underlying this association remain unclear.

Researchers conducted a longitudinal analysis of data from the Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) trial, which randomized pregnant women who smoked to receive either vitamin C or placebo. Children’s forced expiratory flow measurements and wheeze occurrences were assessed at ages 3, 12, and 60 months.

The key findings of the study were as follows:

  • Children whose mothers received vitamin C supplementation during pregnancy exhibited significantly higher forced expiratory flow values compared to those whose mothers received placebo.

  • Wheeze occurrence was significantly lower in children whose mothers received vitamin C supplementation, particularly between ages 4 and 6 years.

  • Approximately 54.2% of the association between vitamin C supplementation and reduced wheeze was mediated through improved forced expiratory flow.

  • Maternal smoking during pregnancy was directly associated with wheeze occurrence in offspring.

The study provides evidence supporting the beneficial effects of vitamin C supplementation during pregnancy on children’s respiratory health, particularly in the context of maternal smoking. Improved airway function mediated the association between vitamin C supplementation and reduced wheeze, highlighting a potential mechanism of action.

Vitamin C supplementation during pregnancy may offer protective effects against wheeze in offspring exposed to maternal smoking. These findings underscore the importance of prenatal interventions in mitigating the adverse respiratory effects of maternal smoking and the potential role of vitamin C supplementation in improving children’s respiratory outcomes. Further research is warranted to elucidate the long-term effects and mechanisms of action of vitamin C supplementation on respiratory health in children.

Reference:

McEvoy, C. T., Shorey-Kendrick, L. E., MacDonald, K. D., Park, B. S., Spindel, E. R., Morris, C. D., & Tepper, R. S. (2024). Vitamin C supplementation among pregnant smokers and airway function trajectory in offspring: A secondary analysis of a randomized clinical trial. JAMA Pediatrics. https://doi.org/10.1001/jamapediatrics.2024.0430

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Obesity linked to poor response to treatment in RA patients during 48-week follow-up period: Study

Obesity linked to poor response to treatment in RA patients during 48-week follow-up period suggests a new study published in the RMD Open.

This report from the NORD-STAR (Nordic Rheumatic Diseases Strategy Trials and Registries) trial aimed to determine if obesity is associated with response to conventional and biological antirheumatic treatment in early rheumatoid arthritis (RA). This report included 793 participants with untreated early RA from the randomised, longitudinal NORD-STAR trial, all of whom had their body mass index (BMI) assessed at baseline. Obesity was defined as BMI ≥30 kg/m2. All participants were randomised 1:1:1:1 to one of four treatment arms: active conventional treatment, certolizumab-pegol, abatacept and tocilizumab. Clinical and laboratory measurements were performed at baseline and at 8, 12, 24 and 48-week follow-up. The primary endpoint for this report was response to treatment based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) remission and Disease Activity Score with 28 joints using C-reactive protein (DAS28-CRP) <2.6 stratified by BMI. Results: Out of 793 people included in the present report, 161 (20%) had obesity at baseline. During follow-up, participants with baseline obesity had higher disease activity compared with those with lower BMI, despite having similar disease activity at baseline. In survival analyses, obesity was associated with a lower likelihood of achieving response to treatment during follow-up for up to 48 weeks (CDAI remission, HR 0.84, 95% CI 0.67 to 1.05; SDAI, HR 0.77, 95% CI 0.62 to 0.97; DAS28-CRP <2.6, HR 0.78, 95% CI 0.64 to 0.95). The effect of obesity on response to treatment was not influenced by the treatment arms. In people with untreated early RA followed up for up to 48 weeks, obesity was associated with a lower likelihood of good treatment response, irrespective of the type of randomised treatment received.

Reference:

Dubovyk V, Vasileiadis GK, Fatima T, et al. Obesity is a risk factor for poor response to treatment in early rheumatoid arthritis: a NORD-STAR study. RMD Open. 2024;10(2):e004227. Published 2024 Apr 4. doi:10.1136/rmdopen-2024-004227

Keywords:

Dubovyk V, Vasileiadis GK, Fatima T, Obesity, poor response, treatment, rheumatoid arthritis, RA patients, 48-week follow-up period, RMD Open

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Cardiology team performs transcatheter edge-to-edge repair with newly approved device

UC Davis Health cardiology team members are among the first in the country to treat patients with tricuspid regurgitation, or a leaky heart valve, by using a groundbreaking catheter.

The minimally invasive procedure, a transcatheter edge-to-edge repair (TEER), is made possible with a new medical device called the Abbott TriClip™ system.

UC Davis Medical Center is one of the first sites nationwide to have commercial access to TriClip and is the first hospital in Western United States to utilize the system since it was approved by the U.S. Food and Drug Administration (FDA) last week. UC Davis also hosted clinical trials for the procedure in 2023.

“We are excited to offer our patients this novel treatment that offers meaningful improvement in quality of life without the high procedural risk often associated with tricuspid surgery,” said Gagan D. Singh, associate professor of cardiovascular medicine and the surgeon who performed the first procedure at UC Davis Medical Center.

Tricuspid regurgitation is a condition in which the tricuspid valve of the heart fails to close completely. This can allow blood to leak backward into the atrium from the tricuspid valve, causing the patient’s heart to pump harder to move blood through the valve.

Tricuspid regurgitation affects an estimated 1.6 million Americans. Symptoms include active pulsing in the neck veins, enlarged liver, fatigue and swelling throughout the body.

Current nonsurgical treatments include diuretics (medicines that help remove excess fluid and salt) and drugs aimed at easing symptoms. Left untreated, tricuspid regurgitation can lead to atrial fibrillation, heart failure, kidney disease and even death.

“Severe tricuspid regurgitation is a debilitating condition that is associated with substantial morbidity,” said Jason H. Rogers, professor of cardiovascular medicine. “Patients with tricuspid regurgitation are extremely high risk for any type of surgical intervention, so historically they have just been monitored and treated with diuretics.”

Tricuspid transcatheter edge-to-edge repair procedure

The human heart has four valves, and if any of them leak, there is no universal way to repair them. For example, the mitral valve can be repaired with a catheter-based system. But the same catheter can’t be used on the tricuspid valve due to the valve’s its location, thinness and variability.

The new system is designed specifically for the tricuspid valve’s position, location and shape. With the patient under general anesthesia, the device is delivered to the heart through a catheter, starting in the groin and guided by X-ray and ultrasound. Once in place, the clip brings together portions of the leaflets (flaps of the valve), improving the seal and reducing the leaking.

The device was tested for its safety and clinical efficacy as part of the TRILUMINATE Pivotal trial. UC Davis Health was one of the sites with the highest enrollment rates in the national trial.

“This minimally invasive approach allows the heart to pump blood more efficiently and relieve symptoms of tricuspid regurgitation,” said Rogers, who will be performing additional tricuspid TEER procedures.

A leader in transcatheter edge-to-edge repair

UC Davis Health has been a leader in transcatheter edge-to-edge repair for nearly two decades. In addition to the transcatheter tricuspid valve repair procedure, the medical center’s cardiac services offer several minimally invasive catheter-based mitral valve procedures.

“Being one of the first centers in the country to offer commercial availability of the TriClip system is a true honor and a testament to the outstanding team-based approach to patient care at UC Davis Health,” added Singh. “The UC Davis Structural Heart Team is among the best and most comprehensive in the nation. Our mission of providing complete, efficient and high-quality care to the patients we care for is what drives us to lead the field.”

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