Landmark COAPT trial Demonstrates the Benefit of Transcatheter Mitral-Valve Repair Using MitraClip in Patients with Heart Failure TCT 2018: Findings of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) trial

The spectacular results of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) trial, presented at TCT 2018, show that transcatheter mitral valve approximation using the MitraClip, on a background of maximally tolerated guideline-directed medical therapy (GDMT) was superior to GDMT alone in the reduction of Heart Failure (HF) hospitalization and mortality in symptomatic HF patients with grade 3-4+ Mitral regurgitation (MR). These landmark findings were simultaneously published today in the New England Journal of Medicine. Continue reading

Polymer-Free Amphilimus-Eluting stents: A Novel Elution Technology Results of the ReCre8 study, TCT 2018

Polymer-free amphilimus-eluting stents (PF-AES) are non-inferior to permanent-polymer zotarolimus-eluting stents (PP-ZES) in terms of target-lesion failure at 12 months, according to the results of the ReCre8 study, presented by Pieter R. Stella, MD, Ph.D. (University Medical Center, Utrecht, the Netherlands) at TCT 2018. The results for the first RCT comparing PF-AES versus latest generation PP ZES in an all-comers PCI population were simultaneously published in Circulation. Continue reading

Polymer coated sustained-release Eluvia DES outshines non-polymer coated Zilver DES for femoropopliteal artery stenosis Clinical outcomes at 1 year presented at TCTMD 2018

A randomized global, prospective, multi-center, single-blind trial comparing the Eluvia paclitaxel-eluting stent (Boston Scientific) to  Zilver PTX paclitaxel-eluting stent (Cook Medical) has shown that the Eluvia stent outperformed Zilver in terms of efficacy, which was defined as primary patency at 12 months. These findings, published in The Lancet, were presented by Dr. William Gray at the annual TCT 2018 conference held in San Diego today. Continue reading

SORT-OUT and BIONYX Successfully Demonstrate Non-Inferiority in the World of Drug-Eluting Stents Results from the 30th Annual TCT Conference 2018, San Diego

Findings from the SORT-OUT trial, presented at the 30th annual Transcatheter Cardiovascular Therapeutics (TCT) conference 2018 held at San Diego, showed that at 12 months, polymer free Biolimus A9-coated BioFreedom stent was non-inferior to the thin strut, biodegradable polymer cobalt-chromium sirolimus-eluting Orsiro stent in an all-comers patient population. Continue reading

Physician burnout: An Emerging National Epidemic

Results of two studies published in the latest issue of the JAMA have focussed on the syndrome of physician burnout and rates of career choice regret within the US medical establishment. While findings from one study showed that a high prevalence of symptoms of burnout was present with substantial variation with differing specialties, a systematic review found marked variation in the prevalence estimates of burnout among physicians and inconsistency in burnout definitions, thereby underscoring the dilemmas in the assessment of this fast-growing problem. Continue reading

Apple Watch Series 4 Receives FDA Approval as a Class II Medical Device

The Apple watch series 4 received FDA approval as a class II medical device. Apple claims that the device can detect falls and arrhythmias. It can also record an electrocardiogram (ECG) in 30 seconds “anytime and anywhere,” according to Apple. Continue reading

Early Discharge Following Uncomplicated TAVR Safe, According to a Meta-Analysis

A recent meta-analysis published in the Journal of American College of Cardiology has shown that early discharge (ED) after uncomplicated Transaortic valve replacement (TAVR) is safe and has no negative impact on discharge to 30-day mortality or the need for permanent pacemaker insertion (PPI). Continue reading

ASPREE: Another Warning Bell for Aspirin, “Wonder Drug”Fails to Work Wonders Results of Aspirin in Reducing Events in the Elderly (ASPREE trial)

The results of the Aspirin in Reducing Events in the Elderly (ASPREE) trial published in the New England Journal of Medicine showcase higher all-cause mortality among apparently healthy older adults receiving daily aspirin as compared to placebo, coupled with the shocking finding of mortality being attributed primarily to cancer, thereby painting a bleak picture of Aspirin (ASA) and heralding an end to its use in primary prevention. Continue reading

Do Valsartan Contaminants NDMA and NDEA Bear A Potential Cancer Risk? Danish nationwide cohort study on N-nitrosodimethylamine (NDMA) contaminated valsartan products and risk of cancer, FDA notes second contaminant

The discovery of Valsartan products that were contaminated with NDMA, in July 2018, in drug products manufactured in China, triggered the withdrawal of all affected products by medical agencies across Europe and the United States. Being one of the most well characterized and potent animal carcinogens known, Pottegard and his colleagues conducted an expedited observational cohort study using the nationwide Danish healthcare registry. They aimed to quantify the potential effects of NDMA contaminated valsartan products in terms of increased cancer risk, in order to provide timely information for regulatory bodies evaluating its carcinogenic effects. Results from this Danish cohort study, published in the BMJ, however, failed to show a significant increase in overall short-term cancer risk due to consumption of NDMA contaminated valsartan. Continue reading

Can TTR levels Determine Long-term Prognosis in AFib Patients on Vitamin K Antagonists? Outcomes Among Patients With Atrial Fibrillation and Appropriate Anticoagulation Control

Findings from a Danish nationwide registry conducted among patients with Atrial Fibrillation (AF), initiated on Vitamin K Antagonists (VKA) for stroke prevention between 1997 and 2011, found that almost one-half of patients with prior good level of VKA control (TTR ≥70%) had TTR <70% during the following year. Additionally, those with a prior TTR of ≥70% had a limited long-term prognostic value for stroke, thromboembolism or major bleeding risk, according to the online publication in JACC. Continue reading

Operator Experience of Atleast 225 Procedures Associated With Improved TAVR Outcomes The Learning Curve and Annual Procedure Volume Standards for Optimum Outcomes of Transcatheter Aortic Valve Replacement

Findings from an international TAVR registry involving 16 centers and spanning over a decade have important implications for operator training and patient care at centers performing TAVR. The study, published in JACC Cardiovascular Interventions, is a testament to the learning curve that still exists with both greater procedural safety and lower mortality rates reported when TAVR is performed by experienced operators. Additionally, TAVR performed at low annual volume (<50 procedures) institutions is associated with decreased procedural safety and higher patient mortality. This stepwise improvement in patient outcomes bears important implications for operator training and patient care at centers performing TAVR. Continue reading

Angiographic Completeness Not Associated With Outcomes Following FFR-guided PCI Prognostic Value of the Residual SYNTAX Score After Functionally Complete Revascularization in ACS

Researchers have confirmed that the extent of residual angiographic disease calculated using the residual SYNTAX score (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) or RSS has no association with ischemic events occurring subsequently in patients presenting with ACS. The study, published in JACC, reinforces the concept that functionally complete revascularization is applicable even in ACS patients. Continue reading

UK based RCT Emphasizes on Long Term Cardiovascular Benefits of Antihypertensives and Statins Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) Legacy Study: 16 year follow up results

The Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) Legacy Study is a UK based trial that reports long-term beneficial effects of antihypertensives and statins in terms of mortality and cardiovascular outcomes after 16 years of follow-up in patients with hypertension. Continue reading

Biodegradable Polymer Sirolimus- Eluting Stent Proven Non-Inferior to Durable-Polymer, Everolimus-Eluting Stent BIOSCIENCE 5 Year Outcomes: Results from ESC 2018

Results of the BIOSCIENCE study that were presented at the ESC Annual Congress by Dr. Thomas Pilgrim, University Clinic for Cardiology, Bern, Switzerland, show that the 5-year risk of target lesion failure among patients undergoing percutaneous coronary intervention (PCI) is similar after implantation of the ultrathin-strut, biodegradable-polymer sirolimus-eluting stents as compared with thin-strut, durable-polymer, everolimus-eluting stents. However, higher incidence of all-cause and non-cardiovascular mortality in patients treated with the biodegradable polymer sirolimus-eluting-stents as compared with the durable-polymer stents eluting everolimus warrant careful scrutiny in ongoing clinical trials. The announcement of the results of this trial at the ESC was accompanied by a publication in the Lancet. Continue reading

Treating the culprit lesion associated with decreased mortality versus immediate multi-vessel PCI in cardiogenic shock Galvanizing results from the CULPRIT-SHOCK trial: 1 year follow-up results presented at ESC 2018

 In a randomized multi-center clinical trial that enrolled more than 700 patients with multi-vessel coronary artery disease and acute myocardial infarction (MI) with cardiogenic shock, it was shown that percutaneous coronary intervention (PCI) of the culprit lesion only (with the option of staged revascularization of nonculprit lesions) was associated with better clinical outcomes compared to immediate multi-vessel PCI. It was found that at 30 days, there was a 9.5% absolute reduction in the rate of the primary endpoint of death or renal replacement therapy in patients randomized to culprit-lesion only revascularization. Previously DANAMI-3-PRIMULTI, PRAMI, and CvLPRIT trials have suggested that there may be a benefit to complete revascularization but those studies did not enroll patients with hemodynamic instability or cardiogenic shock. Consequently, this led to the inclusion of immediate multi-vessel PCI in the 2015 ACC/AHA/SCAI STEMI guidelines as a Class II-b recommendation (can be considered). Continue reading

Coronary Microvascular Dysfunction: A Promising Therapeutic Target in Heart Failure with Preserved EF? PROMIS-HFpEF: Results from ESC 2018

PROMIS-HFpEF (PRevalence Of MIcrovascular dySfunction in Heart Failure with Preserved Ejection Fraction) is an echocardiographic trial showcasing a high prevalence of coronary microvascular dysfunction (CMD) in HFpEF and its association with systemic endothelial dysfunction (RHI, UACR) and markers of HF severity (NT-proBNP and RV dysfunction). The results of the trial were recently published in the European Heart Journal. Continue reading

Lorcaserin proven safe as weight loss agent in obese patients CAMELLIA-TIMI 61 trial: Results from ESC 2018, Munich

The selective serotonin 2c receptor agonist, Lorcaserin has been proven to be effective in the promotion of sustained weight loss through appetite suppression in obese and overweight patients, with no increase in cardiovascular events, according to the CAMELLIA-TIMI 61 (Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients–Thrombolysis in Myocardial Infarction 61) trial, presented at the ESC conference in Munich. Continue reading

Cancelled Cath Lab Activation Based on Prehospital EKG, A Single Center Study

A new single-center study has shown that the catheterization laboratory (CCL) activation in response to a prehospital ECG interpreted as ST-segment elevation myocardial infarction (STEMI) can be frequently canceled which represents an economic burden and affects the patient satisfaction negatively. Continue reading

Transcatheter Interatrial shunt device appears safe at 1 year for heart failure with preserved ejection fraction ESC 2018: REDUCE LAP HF-1, 1 year results from phase 2

The 1-year results of a phase 2, sham-controlled RCT have confirmed the safety of a transcatheter interatrial shunt device (IASD; Corvia Medical) with no significant cardiovascular or renal events as compared to those receiving sham control treatment. It has also confirmed the long-term patency of the device. The findings were presented at the ESC and have also been simultaneously published in JAMA Cardiology. Continue reading

Omega-3 fatty acid Supplements Show No Benefit in Cardiovascular Prevention in Diabetes Says ASCEND, the largest and longest placebo controlled trial of omega-3 fatty acids

A randomized trial in patients with diabetes without evidence of cardiovascular disease has shown there to be no significant difference in the risk of serious cardiovascular events in those administered omega−3 fatty acids as compared to placebo. Continue reading