PHARMeMED’s Post

Functional MR Mitra clip. Try and try again the device for dollars, still no success NEWS Conference News ESC 2024 RESHAPE-HF2 Is a Win for MitraClip in FMR—Not Even close Investigators need to understand and implement the GDMT for HFrEF. Only 20% were on all 4 drugs-SGLT-2is Only 60% on 3 drugs-MRBs 76% on 2 drugs-ACEIs 94% on one drug - ß blocker In the RESHAPE-HF2 trial, patients were treated with guideline-directed medical therapy (GDMT) as part of the study protocol. Here’s a breakdown of the percentage of patients using each of the four main GDMT drug classes: LONDON, England—Anyone hoping that a third “tiebreaker” trial of the MitraClip against optimal medical therapy (OMT) would help clarify the role of transcatheter edge-to-edge repair (TEER) in heart failure patients with functional mitral regurgitation (FMR) may leave the European Society of Cardiology (ESC) Congress 2024 still scratching their heads. RESHAPE-HF2, the investigator-initiated, 505-patient trial released Saturday at a Hot Line session, has been randomizing patients since 2015 and arrives nearly 6 years after COAPT and MITRA-FR famously delivered conflicting results. According to Stefan Anker, MD, PhD (Charité Universitätsmedizin Berlin, Germany), who presented RESHAPE-HF2 at ESC, the results are a clear win for the MitraClip (Abbott), which was superior to OMT alone across all three of the trial’s primary endpoints, including the combined endpoint of death or heart failure (HF) hospitalizations. No significant differences, however, were seen for mortality alone. The multiple simultaneous publications in the Journal of the American College of Cardiology to coincide with Saturday’s presentation speak to both the enormous interest in this trial and the persistent unknowns. One editorial, by COAPT principal investigator Gregg Stone, MD, and Bhavanadhar Penta, MBBS (both Icahn School of Medicine at Mount Sinai, New York, NY), describes RESHAPE-HF2 as “erasing all doubt” that MitraClip trumps OMT in patients with moderate-to-severe MR. While a number of key limitations of RESHAPE-HF2 warrant a cautious interpretation, this latest study relegates MITRA-FR to being “the ‘outlier’ trial”—potentially because the earlier French study enrolled patients with greater left ventricular dilation, they posit. By contrast, a second editorial by MITRA-FR lead investigator Jean-François Obadia, MD, PhD (Hôpital Cardiovasculaire Louis Pradel, Bron, France), and colleagues questions whether “RESHAPE-HF2 is good enough to be a tiebreaker.” An intervention which had significant adverse effects, at high expense compared to non GDMT omt ( only 20% on all 4 drugs ) shows no MR reduction seems inferior to standard of care OMT- All 4 pillars

Genentech’s Subcutaneous Ocrevus One-Year Data Demonstrates Near-Complete Suppression of Clinical Relapses and Brain Lesions in Patients With Progressive and Relapsing Forms of MS – Results from the Phase III study showed that subcutaneous (SC) injection was consistent with IV infusion and demonstrated near-complete suppression of relapse activity (97%) and MRI lesions (97.2%) through 48 weeks – – The twice-yearly, 10-minute SC injection has the potential to expand the usage of Ocrevus to treatment centers without IV infrastructure or with IV capacity limitations – – U.S. FDA and EMA accepted filings based on the data from OCARINA II, with EU approval anticipated mid-2024 and U.S. approval anticipated September 2024 – “Updated results from OCARINA II further underline the potential benefits of subcutaneous Ocrevus for patients with both relapsing and progressive forms of MS,” said Scott Newsome, D.O., lead author, Johns Hopkins University School of Medicine. “Patients treated with subcutaneous Ocrevus experienced appropriate B-cell suppression and impressive near-complete suppression of new inflammatory disease activity. These results demonstrate the potential of subcutaneous Ocrevus as a treatment option that can be matched to the individual needs of people with MS and healthcare professionals.” Additional data continued to show that the safety profile of Ocrevus SC injection was consistent with the well-established safety profile of Ocrevus IV infusion. No new safety signals were identified for Ocrevus SC. The most common adverse events in the Ocrevus SC group were injection reactions (51.5% of all exposed patients), including erythema (34.8%; skin redness or irritation), pain (17.2%), swelling (9.4%) and pruritus (5.6%; skin itching), all of which were either mild or moderate and none of which led to treatment withdrawal. A total of seven serious AEs were experienced by three (2.6%) and four (3.4%) patients in the Ocrevus SC injection and IV infusion groups, respectively. The OCARINA II abstract was selected as an abstract of distinction by the AAN, based on the quality of the study and the interest to the neurology community. https://lnkd.in/eShr75YM

Dosing in #PRP is a hot topic. We should strive to stay current, but remember foundational principles so we do not go too far with current trends. Heavy emphasis on hot topics has a history of swinging the pendulum too far in the field of #orthobiologics Here is a brief list of #orthobiologics trends that were at one time associated with strong (nearly dogmatic) beliefs, but now those views have softened as we have learned. 1) Activation- some believed PRP needed activation with calcium chloride or thrombin. Interestingly, without any gold-standard study to reference, this topic seems to have all but disappeared from present discussions. 2) Leukocytes- there was a belief that leukocytes must be avoided in the joint. But when BMAC or APS were brought forward, leukocytes were again absent from the conversation. Now, we've come back to admitting maybe some WBCs are helpful. There are at least 2 comparative studies demonstrating that there is no difference between LP- vs LR-PRP for knee OA (both by Filardo et al). 3) Mesenchymal stem cells- early adopters of BMAC touted the MSC content. Then came the realization that BMAC has almost no MSCs in it and that any therapeutic benefit came from sources like IRAP (which comes from the leukocytes!) Present day, there is a strong emphasis on "PRP dosing". Those advocating "high dose" only are not addressing a very large body of literature including the only positive FDA study for knee OA that used a series of lower concentration PRP injections (https://lnkd.in/egkKTqVw) Not only are there multiple RCTs showing that a series of low concentration PRP injections improves outcomes for knee OA (see previous posts for references), but there's more to PRP than the platelet count. I'll cover these other important variables in future posts. Have a great week and keep learning! *PRP for OA is off-label. These posts are intended for education only and do not constitute medical advice*

Etomidate Introduction, Contraindications, Etomidate is an ultrashort-acting, non-barbiturate hypnotic intravenous anesthetic agent. It is administered only by intravenous route. Etomidate has a favorable hemodynamic profile on induction, with minimal blood pressure depression, making it ideal for shock trauma, hypovolemic patients, or patients with significant cardiovascular disease. Etomidate has been approved for use during induction of general anesthesia, rapid sequence intubation, and other indications where short-term anesthesia is warranted. In addition, etomidate is indicated for procedural sedation, maintenance of anesthesia, and short operative procedures such as reducing dislocated joints, tracheal intubation, cardioversion, dilation, curettage, or cervical conization.This activity outlines the indications, mechanism of action, methods of administration, significant adverse effects, contraindications, toxicity, and other key factors (e.g., off-label uses, dosing, pharmacodynamics, pharmacokinetics, monitoring, relevant interactions) of etomidate so that providers can use it appropriately. Contraindications Etomidate is contraindicated in any patient with a known hypersensitivity reaction. Adrenal Suppression: Etomidate is a commonly used sedative during rapid sequence intubation (RSI). In some studies, septic patients have an increased risk of developing adrenal suppression, associated with increased mortality. Since etomidate affects cortisol production, its use in septic patients is controversial.However, data are still lacking to prove that etomidate should be avoided in this patient population. Pediatric Neurotoxicity: Published preclinical studies demonstrate that administering anesthetic and sedation drugs that potentiate GABA activity and block NMDA receptors increase neuronal apoptosis in the developing brain and result in cognitive deficits.Decisions regarding the timing of any elective procedures requiring anesthesia should consider the procedure's benefits weighed against the potential risks.

"Exploring the Role of Evogliptin in Aortic Valvular Calcification Progression" A recent study led by Jae-Kwan Song, Sahmin Lee, and a team of researchers explored whether evogliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, could slow the progression of aortic stenosis (AS) by reducing aortic valve calcification. As medical therapy for AS remains an elusive goal, this study brings important insights to the field. This study, which utilized CorelineSoft’s AVIEW:CAC, randomized 228 patients with AS to receive either a placebo or evogliptin (5 mg or 10 mg). After 96 weeks, no significant difference in aortic valve calcium volume (AVCV) was observed between the evogliptin groups and the placebo. However, the increase in AVCV seen in the second half of the study period in the placebo group was attenuated in the evogliptin groups, hinting at a potential longer-term benefit with evogliptin. Additionally, a significant reduction in active calcification volume was observed at 48 weeks in both evogliptin groups using 18F-NaF PET imaging. While the study did not conclusively show a protective effect of evogliptin, these promising PET imaging results and the potential for slowing calcification over time suggest that larger confirmatory trials are needed to determine the efficacy of DPP-4 inhibitors like evogliptin for patients with calcific aortic valve disease. Additionally, we're excited to announce that AVIEW:CAC will soon include a feature for aortic valvular calcification assessment, enabling more comprehensive evaluations in clinical settings. 📢 For those interested in conducting further research on aortic valve calcification or collaborating on AI-powered diagnostic tools, feel free to reach out to me directly. 📢 We're always open to exploring new research opportunities! You can find the full paper in the Journal of the American College of Cardiology: https://lnkd.in/g5R3jjgs Authors: Jae-Kwan Song MD, Sahmin Lee MD, Yong-Jin Kim MD, Hyung-Kwan Kim MD, Jong-Won Ha MD, Eui-Young Choi MD, Seung-Woo Park MD, Sung-Ji Park MD, Yong-Hyun Park MD, Jae-Hyeong Park MD, Dong Heon Yang MD, Kye Hun Kim MD, Dong Hyun Yang MD, Sangwon Han MD, Sun Young Chae MD, Ji Sung Lee PhD, Jong-Min Song MD, Goo-Yeong Cho MD Journal: Journal of the American College of Cardiology (JACC) "Effect of Evogliptin on the Progression of Aortic Valvular Calcification" by Jae-Kwan Song, Sahmin Lee, Yong-Jin Kim, and others. #Cardiology #AorticStenosis #Evogliptin #Coreline #CalcificAorticValveDisease #ClinicalTrials #ASResearch #AVIEWCAC #AIinHealthcare

Benign Prostatic Hypertrophy (BPH) is a noncancerous condition that causes the prostate gland to enlarge in size which can make it difficult to urinate (Mayo Clinic, 2024). Most patients complain of difficulty starting urination, weak urine stream, frequent urination (Mayo Clinic, 2024). First line pharmacologic treatment for BPH is Tamsulosin which is an Alpha adrenergic antagonist (2020 Nurse's Drug Handbook). Tamsulosin’s initial dose is 0.4mg capsules daily, patient should take pill 30 minutes after a meal for 2-4 weeks and then increase to 0.8 mg daily if there is no response to initial dose (2020 Nurse's Drug Handbook). Another option could be Tadalafil which can also help to treat benign prostatic hyperplasia (2020 Nurse's Drug Handbook). The most common adverse effect are arrhythmia, A-Fib, chest pain, angioedema (2020 Nurse's Drug Handbook). It is important to educate the patient on the risks related to the cardiovascular system, patient should avoid potentially hazardous activities until effects are known, educate patient on the importance of changing position slowly (2020 Nurse's Drug Handbook). References 2020 Nurse’s Drug Handbook. (2020). . Jones & Bartlett Learning, LLC. Mayo Foundation for Medical Education and Research. (2024a, March 1). Benign prostatic hyperplasia (BPH). Mayo Clinic. https://lnkd.in/e5jAznXt 

🌟Introducing Edulis Therapeutics: Revolutionizing Gastrointestinal Medicine🌟 Join me on an exciting journey as we explore groundbreaking innovations in healthcare. Edulis Therapeutics is developing an endoscopic drug delivery system to further their mission of transforming care for millions of patients worldwide in the field of gastrointestinal medicine. Let's dive into how Edulis is reshaping the landscape of healthcare with precision, innovation, and a commitment to improving lives. Their roadmap showcases a promising future, with ongoing developments in therapeutic devices and programs targeting various disease areas, including Crohn's Disease and Inflammatory Bowel Disease. While some projects are still in the preclinical phase, Edulis is dedicated to advancing these innovations to bring meaningful solutions to patients in need. Let's delve into the future of gastrointestinal medicine together! Company Name: Edulis Therapeutics Innovative Solutions: Edulis Therapeutics introduces a groundbreaking endoscopic drug delivery system for gastrointestinal disorders. Problem: Traditional drug administration methods often lack precision, leading to systemic side effects and high costs for gastrointestinal patients. Solutions: Edulis' solution: a thin, bioresorbable implant delivers medication directly to the affected gastrointestinal areas, ensuring optimal outcomes with minimal side effects. Target Audience: Over 1 million patients globally, alongside healthcare specialists in gastroenterology, endoscopy, and gastrointestinal surgery. Innovative Aspects: Precise Drug Delivery: Thin design and bioresorbable polymer ensure accurate medication delivery. Long-term Management: Edulis implants offer sustained therapeutic management for up to 12 months, reducing interventions. Reduced Complications and Costs: Minimizing side effects, Edulis lowers healthcare costs for gastrointestinal disorders. Doctor-Friendly Innovation: User-friendly design ensures accessibility for GI clinicians. Impact: Edulis' system aims to improve the lives of millions suffering from gastrointestinal disorders by advancing solutions that are currently in the trial stage, promising transformative benefits. Related Facts: Globally, millions suffer from inflammatory bowel diseases. Edulis addresses these challenges with precise drug delivery and long-term management solutions. Website: https://www.edulis.xyz/ #HealthcareInnovation #GastrointestinalMedicine #EdulisTherapeutics

Part 1/3 THE 4 PILLARS OF GUIDELINE DIRECTED MEDICAL THERAPY−GDMT The following medication classes are crucial, each contributing to the REDUCTION of Morbidity (worsening Heart failure/ hospitalization) & Mortality in patients with SYSTOLIC cardiac dysfunction or symptomatic HEART FAILURE w/ reduced Ejection Fraction (HFrEF) PILLAR 1: β1 SELECTIVE RECEPTOR BLOCKERS •Clinical trials support the effectiveness specifically of Metoprolol succinate, Carvedilol & Bisoprolol. However, some experts believe that the benefits can be generalized as a class effect, whereas others do not •Titrate gradually to the maximum tolerated dose, even over other first line treatments w/ ARNI, ACEi, ARB &/or ARA, if they become limiting… as beta blockade appears to be the MOST EFFECTIVE treatment for survival in patients w/ SYSTOLIC disease PILLAR 2: ANGIOTENSIN 2 RECEPTOR/ NEPRILYSIN INHIBITORS (ARNIs) •Preferred over ACEi or ARB treatment, due to its greater effect on Morbidity & Mortality. However, if not tolerated, the preferred sequence for a replacement is ARNI > ACEi > ARB •Although dual K sparing treatment is often used, do NOT combine as triple therapy (ARNI, ACEi, ARB &/or ARA) due to HYPERkalemia risk. Also, do not combine an ACEi & ARNI due to Angioedema risk via dual inhibition of Bradykinin metabolism •If transitioning a patient from an ACEi to an ARNI, allow for a 36hour wash−out period off the ACEi in order to ↓ the risk of Angioedema. This wash−out period is not needed if transitioning from an ARB PILLAR 3: SODIUM−GLUCOSE COTRANSPORTER 2 (SGLT2) INHIBITORS •Although the effects are not explained by glucose lowering, it is likely a class effect. Currently, only Dapagloflozin & Empagliflozin are FDA approved for this indication, irrespective of having Diabetes mellitus •This is the only pillar currently understood to also ↓Mortality for patients w/ DIASTOLIC cardiac dysfunction or symptomatic HEART FAILURE w/ preserved Ejection Fraction (HFpEF) PILLAR 4: ALDOSTERONE RECEPTOR ANTAGONISTS (ARAs), functioning as K Sparing diuretics •Eplerenone is preferred to Spironolactone, as it avoids gynecomastia & sexual side effects Visit our Website/ Medical wards app knowmedicine.net #medicalstudent #medicalresident #meded #medicalschool #internalmedicine #medicaleducation #medstudent #imresidency #medicalapp #foamed #hospitalist #hospitalmedicine #gdmt

The 2024 Transcatheter Cardiovascular Therapeutics (TCT) conference showcased cutting-edge innovations in cardiovascular care, with updates from major companies on technologies like heart valves, drug-eluting implants, and more.   Here’s are the updates from the #MedTech giants at TCT 2024:   Boston Scientific: The Acurate neo2 aortic valve system, aimed at treating patients with severe symptomatic aortic stenosis, failed to meet the primary endpoint when compared to Edwards Sapien and Medtronic Evolut. Despite this, Boston Scientific officials are optimistic that the findings will aid in optimising future TAVR procedures as the field develops.   Edwards Lifesciences: Shared favourable outcomes from two TAVR trials: one showing superior results for asymptomatic severe aortic stenosis patients treated with Edwards TAVR over clinical surveillance, and another demonstrating the Evoque system’s advantage over optimal medical therapy in treating structural heart disease.   Inari Medical: Showcased the FlowTriever device, designed for pulmonary embolism treatment, in the PEERLESS trial. The device outperformed catheter-directed thrombolytics, demonstrating quicker recovery, fewer ICU admissions, and shorter hospital stays, highlighting FlowTriever as a less invasive and effective PE treatment option.   Shockwave Medical(Johnson & Johnson MedTech): completed the all-female Empower CAD IVL trial, which investigates the unique cardiovascular needs of women in PCI. This study addresses the critical need for gender-specific data, aiming to improve procedural outcomes for women with complex coronary disease.   Abiomed (Johnson & Johnson): The Impella ECP pump achieved its primary endpoint with a 6.3% major adverse event rate in high-risk PCI patients, a promising outcome. The device’s closure success rate also emphasises its potential role in challenging coronary interventions.   Medtronic: released two-year data on the Symplicity Spyral RDN system, a minimally invasive device using radiofrequency energy to treat hypertension by targeting renal nerves. Results showed lasting reductions in both ambulatory and office-based blood pressure, further supporting the system’s effectiveness.   These presentations collectively underscore the innovation and evolution in cardiovascular care. https://lnkd.in/gzbQ3TMJ #MedTechNews #MedicalDevices #HealthcareInnovation #MedTechIndustry #HealthTech #HealthcareTechnology #MedDeviceNews #HealthcareNews #MedTechTrends

As May draws to a close, the LSI Alumni are ending the month on a high note with another week of impressive milestones. This week the #LSIAlumni received Breakthrough Device Designation, granted FDA clearance, shared pivotal trial results, and much more on the road to #LSIEurope24. Atraverse Medical, Inc. — John Slump → Raised a $12.5M Seed funding round and received FDA clearance for its HOTWIRE™ radiofrequency (RF) guidewire. → The company's proprietary HOTWIRE™ system aims to enhance outcomes and streamline workflows for physicians treating cardiovascular disease in millions of patients worldwide. Canary Medical Inc. — Bill Hunter → Received FDA Breakthrough Device Designation for its Canturio® Lumbar Cartridge (canturio®lc) with Canary Health Implanted Reporting Processor (CHIRP®) System. → The canturio®lc, used with a Lumbar Interbody System for spinal fusion from L1-S1, provides objective kinematic data during post-surgical treatment. Ceretrieve — Maysa Mustafa → Announced the successful results of the company's multicenter, single-arm study, showcasing the capabilities of its state-of-the-art aspiration catheter. → Ceretrieve's vision is to be the doctor's first-choice device in treating ischemic stroke offering complete treatment with superior performance in one device. Colospan Ltd. — Boaz Assaf → The FDA has approved a product line extension to its Intraluminal Bypass Device as part of the company’s investigational device exemption (IDE) application. → Colospan’s CG-100 is an investigational device for patients with colorectal cancer requiring an anastomosis and are to receive a protective stoma under routine clinical practice. Galvanize Therapeutics, Inc. — Jonathan Waldstreicher, MD → Received FDA 510(k) clearance for its INUMI Flex endoscopic needle for use with the Aliya® PEF System. → Aliya, with the INUMI Flex needle, is the first commercially available system to deliver PEF energy through an endoscope, enabling physicians to reach and non-thermally ablate soft tissue lesions. Linshom Medical, Inc. — Richard H. → Awarded a $100K grant from the MIPS program to support a clinical study of its respiratory monitoring device. → The study will evaluate the Linshom Medical device's ability for early detection of patient respiratory decline in the Post Anesthesia Care Unit. US Medical Innovations, LLC — Jerome Canady → Received FDA 510(k) clearance for the Canady Helios Cold Plasma™ Ablation System for the ablation of soft tissue during surgery. → The Canady Helios Cold Plasma™ System introduces a novel approach to soft tissue ablation using plasma. Vitestro — Toon Overbeeke → Shared its Pivotal Trial results confirming performance, safety, and patient acceptance of its autonomous blood draw technology. → Vitestro's device combines AI-based, ultrasound-guided imaging with robotic needle insertion, ensuring accurate and secure blood collection. Congratulations to all the LSI Alumni who made major news this week!