Patrick Campbell

This article was originally published in Practical Cardiology.

The US Food and Drug Administration (FDA) has announced Medtronic, Inc. would cease sale and distribution of the HeartWare Ventricular Assist Device (HVAD) System and issued a warning to clinicians to stop new implants of the device.

Data show instances of internal pump delay or failure to restart had an association with increased risk of adverse events and mortality.

There were more than 100 complaints received by Medtronic, Inc. including 14 reports involving mortality and 13 patients requiring explant.

Urgent Medical Device Communication Notification Letter

 to provide information for clinicians and patients.

The device was approved in 2017 for destination therapy as the world smallest centrifugal-flow VAD designed to reduce surgical invasiveness, improve recovery times, and enhance patient outcomes.

Approximately 2000 patients in the US and 4000 patients worldwide have been implanted with the HVAD system.

Prior to the decision to halt sale and distribution of the HVAD system, the company made a voluntary recall of a subset of the pumps In December 2020.

Bram Zuckerman, MD, director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, noted in the 

 that the FDA’s highest priority is patient health and safety.

“We have been carefully monitoring the adverse events associated with this device and support its removal from the marketplace,” Zuckerman said. “The FDA is working closely with both Medtronic and Abbott to ensure patient care is optimized during this transition period and that there is an adequate supply of devices available to provide this patient population with options for end-stage heart failure treatment.”

The FDA has called for clinicians to consider alternative systems and urged advisement to patients with the HVAD system to continue normal use and contact the company for replacement items.

“The FDA’s alert is designed to quickly inform health care providers of this critical information so that patients with the current HVAD System continue to receive appropriate care and management,” Zuckerman continued.

Nnamdi Njoku, President of Mechanical Circulatory Support at Medtronic noted that safety and well-being of patients was their main concern.

“We know the greatest commitment we make to doctors and patients is to consistently make safe medical technologies that alleviate pain, restore health, and extend life,” Njoku said.

Both the FDA and Medtronic ask patients and clinicians to report adverse events or safety problems with the HVAD system to the FDA MedWatch Adverse Event Reporting Program.

Articles

Medtronic has halted sale of the HeartWare Ventricular Assist Device System after more than 100 complaints were filed, including 14 reports of mortality.

FDA Issues Warning to Stop New Implants of Medtronic HVAD System

This article was originally published on EndocrinologyNetwork.com.

Semaglutide could help reduce negative cardiovascular events for patients with type 2 diabetes, according to new research presented at the American Heart Association’s (AHA) Scientific Sessions 2020.

An analysis of data from the SUSTAIN 6 and PIONEER 6 trials indicates use of semaglutide was associated with consistent reductions in major adverse cardiovascular events regardless of baseline triglyceride levels in patients with 

The analysis, which was conducted by investigators from St. Michael’s Hospital in Toronto and Brigham and Women’s Hospital, aggregated data from the SUSTAIN 6 and PIONEER 6 trials and concluded semaglutide reduced the risk of major adverse cardiovascular events across multiple levels of baseline triglycerides.

“We found that the incidence rate for MACE in the placebo arm increased across increasing triglyceride levels as evaluated categorically in this analyses. Semaglutide generally reduced the risk of MACE and its components versus placebo across all triglyceride groups,” said Subodh Verma, MD, PhD, a cardiac surgeon-scientist at St. Michael’s Hospital, in his AHA 2020 presentation. “Results were consistent when evaluating triglycerides categorically or as a continuous variable.”

The current study was designed as a posthoc analysis of the trials to assess effects of semaglutide on MACE and its components across triglyceride levels. Briefly, SUSTAIN 6 enrolled 2735 patients and randomized to either 0.5 or 1g semaglutide once weekly or placebo therapy and PIONEER 6 enrolled 3183 and randomized them to daily oral semaglutide or placebo.

The main outcome of interest for the analysis was change in triglyceride levels over time with semaglutide versus placebo in both trials. Additionally, Investigators hoped to determine the risk of first MACE and its components by baseline triglyceride levels and time to first MACE by triglyceride levels at baseline for semaglutide and placebo when pooling data from both trials.

Upon analysis, investigators identified 6417 patients from the trials with information related to baseline triglyceride measurements, These groups were defined as triglycerides 151 mg/dL or less, 151 mg/dL to 205 mg/dL, and more than 205 mg/dL. Results indicated the mean triglycerides for each of the 3 groups were 107.3 (26.0), 176.6 (15.6), and 326.5 (197.1) mg/dL, respectively.

Investigators estimated the effect of semaglutide versus placebo on primary endpoints using Cox regression by triglyceride level categorically and continuously when adjusted for baseline triglycerides and HDL cholesterol. Investigators also noted the analysis was designed to assess impact of statin treatment in these patients as well.

After analysis, investigators determined semaglutide reduced triglycerides versus placebo by 5% in the SUSTAIN 6 trial and 6% in the PIONEER 6 trial (

Further analysis indicated the incidence of MACE with placebo increased across the increasing triglyceride groups. In comparison, semaglutide generally reduced the risk of MACE and its components across all triglyceride groups versus placebo. Additionally, results appeared to be consistent when evaluating triglycerides as a continuous variable and regardless of statin treatment among patients.

“This posthoc analysis of SUSTAIN 6 and PIONEER 6 trials pooled demonstrated that semaglutide reduced triglyceride levels versus placebo in both trials, in which over half of the patients had elevated levels at baseline,” Verma added.

Semaglutide Reduces Mace Consistently Across Baseline Triglyceride Levels in Patients With Type 2 Diabetes: A Post Hoc Analysis of the Sustain 6 and Pioneer 6 Trials

Researchers present new data from the SUSTAIN 6 and PIONEER 6 trials during the virtual AHA 2020 conference. 

Semaglutide Reduces Triglyceride Levels in Diabetic Patients

This article, "LIVMOR Halo AF Detection System Receives 510(k) Clearance from FDA," was originally published in Practical Cardiology.

The US Food and Drug Administration (FDA) has approved the LIVMOR Halo AF Detection System, making it the first prescriptible wearable for continuous 

LIVMOR Inc announced the 510(k) clearance for their wearable solution for continuous heart monitoring.

Deployed through a Samsung wearable device, the LIVMOR Halo System provides continuous monitoring of pulse rhythms for detecting 

 (AF) and is backed by on the results of a clinical trial with more than 250 patients.

"The FDA 510(k) clearance of our LIVMOR Halo™ AF detection system (deployed as an integrated part of the LIVMOR Halo+™ Home Monitoring system powered by Samsung) is a significant milestone for LIVMOR and serves as a foundational cornerstone in our Samsung-based digital health platform,” said Ken Persen, founder and chief executive officer with LIVMOR, in 

. “Starting today, medical professionals across the US can prescribe our LIVMOR Halo™, a patient-engaging and extendable system, for their at-risk patients. This is major step toward achieving our vision of a transformative patient-provider ecosystem that more proactively prevents, detects, and manages chronic conditions."

According to LIVMOR, the Halo System was examined in a multicenter trial comprised of 269 patients that compared the system to concurrently record electrocardiograms. In the trial, ECG recordings were reviewed for accuracy by ECG technicians, cardiologists, and automated algorithms. Results of the trial suggest LIVMOR Halo was 100% sensitive in identifying patients with AF and 93% specific in identifying patients without AF.

“The goal of LIVMOR’s AF detection monitor is to provide cost-effective systemic population monitoring for patients susceptible to having atrial fibrillation, particularly those with paroxysmal or asymptomatic forms of AF and also for those with a prior diagnosis of AF, to provide monitoring clinically useful for the management of the condition.”

The LIVMOR Halo AF Detection System has received 510(k) clearance from the US FDA and becomes the first prescriptible wearable for continuous heart monitoring in patients with atrial fibrillation.

FDA Approves Wearable for Heart Monitoring

An original version of this article was published by sister publication Practical Cardiology

New research indicates incorporating high-sensitivity troponin (hsTn) testing into an American Heart Association/American College of Cardiology (AHA/ACC) cholesterol management guideline-based algorithm for patients with 

atherosclerotic cardiovascular disease (ASCVD)

 could improve risk stratification and care optimization.

Investigators determined incorporation of hsTn testing resulted in the reclassification of 11.9% of patients into a more appropriate risk group when examining use of the biomarker-testing approach in patients from the PEGASUS-TIMI 54 trial.

In an effort to understand whether addition of hsTn testing to guideline-derived ASCVD risk classification, a team led by investigators of the TIMI study group designed and conducted a prospective cohort biomarker substudy of patients from the PEGASUS-TIMI 54 trial. From the 21,162 patients included in the original trial, 8635 were included in the current substudy

The median age of the study cohort was 65 years (IQR, 58-71 years), 76.6% were men, and 96.6% were White individuals. All patients included in the study experienced myocardial infarction 1-3 years prior to enrollment, were at least 50 years of age, and had at least 1 high-risk feature.

For the analysis, patients were assigned to AHA/ACC guideline-derived risk groups classified as very-high risk ASCVD or a lower-risk ASCVD based on their cardiovascular history and comorbidity. Patients were also classified according to hsTnI levels, with threshold points of 2 ng/L and 6 ng/L, which was defined as an undetectable level and the increased risk threshold, respectively. 

This was followed by a joint classification on the basis of clinical features and hsTnI level.

The primary end point of the analysis was a composite of cardiovascular death, myocardial infarction, or stroke. Upon analysis, patients meeting the criteria for the very high-risk ASCVD group had a 3-year event rate of 8.8% when assessing for the primary end point. In comparison, the rate among patients in the lower-risk group was 5.0% (HR, 2.01; 95% CI, 1.58-2.57; 

When stratifying patients according to hsTnI level, 9.0% of patients in the very high-risk group had an undetectable hsTnI level and these patients had a corresponding 3-year event rate of 2.7%, which investigates noted was lower than the overall rate in the lower-risk group. Among patients in the lower-risk group, 22.6% had an hsTnI level exceeding the 6 ng/L risk threshold and these patients had a corresponding 3-year event rate of 9.1%, which investigators noted was comparable to the rate seen in the very high-risk group.

Based on these results, investigators determined the addition of hsTnI levels to guideline-derived ASCVD risk assessments led to a net reclassification index at event rate of 0.15 (95% CI, 0.10-0.21). Furthermore, results indicated use of hsTnI led to reclassification of 11.9% of patients in the substudy.

 Harvey White, DSc, of the Auckland City Hospital and University of Auckland in New Zealand, highlights the potential of adding the biomarker to risk assessment algorithms but also warns against over-interpretation of results.

“It is not clear from the study by Marston and coworkers why increased hs-troponins within the normal range were associated with increased CVD risk," White wrote. "However, even without a complete understanding of the underlying mechanisms for the increased hs-troponin levels, the incremental information on CVD risk makes it very useful for improving risk assessment."

Troponin levels, he explained, should not be viewed solely as a marker for myocardial injury and diagnosis of MI in acute coronary syndrome, but for the frequent use of assessing CVD risk in stable patients with IHD.

Clinical Application of High-Sensitivity Troponin Testing in the Atherosclerotic Cardiovascular Disease Framework of the Current Cholesterol Guidelines

New data shows an adherence to troponin testing could complement optimized care.