Key Points:

• The MitraClip system has been established as a robust platform for transcatheter repair of both degenerative and functional mitral regurgitation. However, it has not been compared against more novel therapies (such as the PASCAL system). The CLASP IID trial is the first RCT to directly compare two transcatheter valve repair therapies for degenerative MR.
• The PASCAL system met the primary safety and effectiveness endpoints of this pivotal noninferiority trial. There was a low composite MAE rate (3.4%) at 30 days, and 97.7% of patients achieved sustained reduction of MR (≤ 2+) at 6 months.
• This trial establishes the PASCAL system as a safe, beneficial therapy for patients with significant symptomatic DMR and prohibitive surgical risk.

Continue reading →

Key Points:

• Stroke is a feared complication of TAVR. However, the potential impact of cerebral embolic protection (CEP) devices is unclear. The PROTECTED TAVR study was a post-market RCT to examine the utility of CEP devices in TAVR patients across all risk categories.
• CEP device use did not result in a significant difference in all strokes at 72 hours or discharge, but it did reduce the rate of disabling strokes in secondary analysis.
• CEP device use was safe, with no difference in the safety composite of all-cause mortality and stroke and only a 0.1% risk of vascular complication related to CEP.

Continue reading →

RESCUE, a phase II, trial presented by Paul M. Ridker, MD, Director of the Center for Cardiovascular Disease Prevention, Brigham and Women’s Hospital, at the American College of Cardiology 2021 meeting and simultaneously published in The Lancet , revealed that the use of ziltivekimab, a fully human monoclonal antibody targeting interleukin-6 (IL-6) ligand and developed specifically for atherosclerosis, was associated with a decrease in the serum level of multiple anti-inflammatory biomarkers among patients with an elevated risk of atherosclerotic disease. Of note, this IL-6 inhibitor was not associated with adverse effects observed with other agents in its class. Continue reading →

Key Points:

• Survivors of out of hospital cardiac arrest (OHCA) suffer very poor outcomes including high rates of mortality and neurologic dysfunction, with optimal protocol for therapeutic hypothermia (TH) unknown
• CAPITAL CHILL is the first double-blinded, randomized trial to evaluate outcomes of moderate hypothermia (31 degrees Celsius) as opposed to mild hypothermia (34 degrees Celsius) after suffering OHCA
• Trial results showed that patients who were cooled below 31 degrees Celsius for 24 hours (moderate TH) showed no difference in terms of death or poor neurological outcomes at six months compared with patients receiving guideline-recommended cooling of 34 degrees Celsius (mild TH)

Continue reading →

KEY POINTS:

• An experimental new therapeutic for heart failure, omecamtiv mecarbil is a novel, selective cardiac myosin activator that was previously shown in the GALACTIC-HF trial to improve heart failure (HF) outcomes amongst patients with heart failure with reduced ejection fraction (HFrEF)
• This extended analysis of the GALACTIC-HF trial showed that omecamtiv mecarbil exerts a greater relative and absolute therapeutic benefit in patients with worsening ejection fraction (EF), in keeping with the drug’s mechanism of selectively improving cardiac function
• The relative and absolute benefits from omecamtiv mecarbil significantly improved with progressively lower EF
• No clear benefit of omecamtiv mecarbil among patients with EF >30% was shown, with more research into this subgroup forthcoming
• The potential role for omecamtiv mecarbil is to be additive to other guideline-directed medical therapies (GDMT) for all patients with LVEF <35% and 1+ heart failure hospitalization in the prior year

Continue reading →

Key Points:

• ISCHEMIA trial patients in the invasive management arm were assessed for completeness in revascularization.
• Patients who achieved complete revascularization were found to have better outcomes at 4 years than those who did not.
• If all patients in the invasive arm were to have achieved complete revascularization, the primary endpoint of ISCHEMIA would have favored invasive management even more strongly at 4 years.

Continue reading →

Presented as a Late Breaking Clinical Trial at the American College of Cardiology 2021 Scientific Sessions by Gregory M. Marcus MD, Professor of Medicine, UCSF, demonstrated that acute alcohol consumption was associated with an elevated risk of discrete atrial fibrillation (AF) event. This event may appear within several hours of the drink and even one drink may increase the risk of such events.
Continue reading →

During the third and last day of the 2021 American College of Cardiology Scientific Sessions, Dr. Marjan Boerma, PhD, Associate Professor, University of Arkansas for Medical Sciences, delivered a presentation on radiation-induced heart disease as a panelist during session 748, “Cardio-Oncology: Today’s Standard of Practice.” Aptly entitled “Unchain My Heart,” the presentation began with a focus on studies demonstrating the now well-known increased risk of heart disease as a late effect of cancer treatment in long-term survivors of Hodgkin’s lymphoma as well as in breast cancer patients who received radiotherapy for left-sided compared with right-sided breast cancers.

Continue reading →

It goes without saying that refractory out of hospital cardiac arrest (OHCA) is associated with very poor outcomes. In recent decades, E-CPR, or the combination of veno-arterial ECMO and mechanical CPR, has emerged as a potential mitigator of refractory OHCA to improve survival. Given the difficulties in design and enrollment of randomized trials in the OHCA space, however, definitive data favoring the use of E-CPR had yet to be established.

In a Late Breaking Clinical Trials Session at the 2021 American College of Cardiology Scientific Sessions, Dr. J. Belohlavek of the Charles University in Prague presented the results of Prague OHCA, a 7-year trial comparing E-CPR to standard ACLS in refractory OHCA. Patients with a presumed cardiac cause of their OHCA were electronically randomized to a hyperinvasive or standard approach to ACLS during bystander chest compressions. The hyperinvasive approach consisted of a rapid transfer to a hospital center with mechanical CPR and/or the implantation of veno-arterial ECMO could be implemented. Standard of care remained at the discretion of the responders but would include manual chest compressions and progression of ACLS.
Continue reading →

Atrial fibrillation and heart failure are two common, costly medical conditions that are increasing in prevalence and incidence in the United States. These two comorbidities often accompany one another in the advanced heart failure population. While goal directed medical therapy for those with heart failure with reduced ejection fraction exists, there is limited evidence of therapy for those with concurrent heart failure and atrial fibrillation.
Continue reading →

Key Points:

• CONNECT-HF, one of the largest heart failure (HF) implementation science trials performed to date, was performed to evaluate how the principles of audit and feedback with personalized feedback by HF and quality improvement experts might impact HF outcomes
• Results showed that this hospital-level intervention did not meaningfully improve clinical outcomes or quality of care delivery at 12 months compared to usual care
• According to the investigators, new approaches are needed to improve care above current quality improvement efforts for patients with HFrEF and next steps include finding alternative QI systems that do improve HF outcomes and rigorously studying those practices

Continue reading →

Key Points:

Myocardial fibrosis has previously been associated with death and repeat hospitalization in patients with heart failure with preserved ejection fraction.

In a phase II clinical trial, Pirfenidone, an oral antifibrotic agent used in the treatment of idiopathic pulmonary fibrosis, was found to significantly decrease myocardial fibrosis when compared to placebo. Dr. Christopher Miller of the University of Manchester presented the results of the PIROUETTE trial (NCT02932566) at a Late Breaking Clinical Trial session at the 2021 American College of Cardiology Scientific Sessions meeting. Given its effect in reducing pulmonary fibrosis, investigators hypothesized that the TGF-B1 antagonist would work similarly in the myocardium and hoped for a clinical benefit in volume status and quality of life as well.
Continue reading →

KEY POINTS:

• Trials for those with heart failure with preserved ejection fraction have not previously demonstrated significant evidence of benefit to date
• The use of the SGLT1/2 inhibitor, sotagliflozin, results in consistent, significant benefit in those with diabetes and reduced, midrange, and preserved ejection fraction

Continue reading →

A restrictive transfusion strategy may no longer be inferior to a liberal transfusion strategy in preventing one-year MACE rates in acute MI and anemia patients, results of a REALITY study analysis presented at the 70th annual meeting of the American College of Cardiology (ACC), found. Continue reading →

Key Points:

• This is the first study to assess the effects of Sacubitril/Valsartan in patients with advanced heart failure with reduced ejection fraction.
• No difference was found between Valsartan and Sacubitril/Valsartan when assessing the change in NT-proBNP levels from baseline in this sicker population.
• The two drugs had similar efficacy and tolerability profiles, with the exception of higher rates of hyperkalemia in the Sacubitril/Valsartan arm.

Continue reading →

Key Points:

• Among patients with suspected acute coronary syndromes (ACS) and ischemia excluded on an initial electrocardiogram, randomized allocation of unmasked hs-cTnT within a 0/1-hour protocol as opposed to a 0/3-hour protocol with troponin T results masked at <29 ng/L was associated with:
  • Reduction in functional stress testing
  • Increase in coronary angiography and revascularization
• Unmasked reporting of hs-cTnT was not associated with a reduction in late death or myocardial infarction (MI) over 12 months of follow up
• Among those presenting with troponins within the masked range (≤29 ng/L), a significant increase in death or MI emerged within 12 months of follow up

Continue reading →

INSPIRATION-S led by Behnood Bikdeli, MD, MS, and presented at the American College of Cardiology 2021 Meeting, failed to show the efficacy of atorvastatin in reducing thrombotic events and all-cause mortality.  According to the presenter, the subgroup analysis demonstrated some hypothesis-generating signals that need to be further investigated in future research.

Continue reading →

ACTION presented at the American College of Cardiology 2021 meeting by Renato D. Lopes, MD, PhD, demonstrated that among patients hospitalized with COVID-19 and elevated D-dimer levels, therapeutic anticoagulation with full-dose anticoagulant did not improve clinical outcomes and increased bleeding compared with prophylactic dose anticoagulation. Continue reading →

Paclitaxel-coated balloons had come under fire in recent years, after a meta-analysis of randomized control trials involving their use for the treatment of peripheral artery disease found an associated with higher mortality when compared to non-drug coated devices. The study led to a letter of caution published by the FDA, leading to hesitance on the part of both physicians and patients to use the devices ever since. In June of 2019, the FDA called for additional long-term safety data to allow Paclitaxel-coated balloons to remain on the market. Continue reading →

Key Points:

• While FFR-guided PCI is superior in chronic coronary syndrome, its role in primary PCI of acute coronary syndrome remained unknown.
• Patients with STEMI and multivessel disease, were randomized to undergo FFR-guided PCI versus angiography-guided PCI of non-culprit lesions after treatment of the culprit.
• There was no difference in MACE at one year between the two intervention arms at one year.

Continue reading →