Breaking News
March 19, 2018 - AcelRx Announces Receipt of Type A FDA Meeting Minutes and Plans to Resubmit the DSUVIA New Drug Application in Q2 2018
March 19, 2018 - Eye Docs Adopt EHRs Despite Reservations
March 19, 2018 - CRISPR enhances cancer immunotherapy
March 19, 2018 - Study finds first evidence of delayed aging among Americans
March 19, 2018 - Essential oils linked to abnormal breast development in boys
March 19, 2018 - ‘Tummy Tuck’ Relieved Postpartum Back Pain/Incontinence
March 19, 2018 - New biomarkers for neuroblastoma, a type of cancer in children
March 19, 2018 - Hookah Smoking Carries a Poisoning Risk
March 19, 2018 - Do Mood and Anxiety Affect MS Disability?
March 19, 2018 - Mean depth of ultrasonographic penetration greater in autism
March 19, 2018 - Platypus milk may help combat antibiotic resistance
March 19, 2018 - U.S. IDE study of THERMOCOOL SMARTTOUCH SF Catheter completes patient enrollment
March 18, 2018 - E-cigarette use exposes adolescents to potentially cancer-causing chemicals
March 18, 2018 - GOP Senator: Solve Opioid Crisis Through Community, Not Policy
March 18, 2018 - Why is ADHD more common in boys than girls?
March 18, 2018 - Measles alert after two passengers with the disease fly into US
March 18, 2018 - FDA looks to remove nicotine from cigarettes
March 18, 2018 - FDA moves to cut nicotine in cigarettes, helping smokers kick habit
March 18, 2018 - Athenex Announces Phase II Clinical Study Results for KX2-391 Ointment for the Treatment of Actinic Keratosis
March 18, 2018 - Surgery Tied to Better Outcomes in Kids with T2D
March 18, 2018 - Scientists use nanotechnology to detect molecular biomarker for osteoarthritis
March 18, 2018 - Research establishes use of chimeric cells as potential therapy for Duchenne muscular dystrophy
March 18, 2018 - Researcher working to develop improved endoscopic probe for colonoscopies
March 18, 2018 - Researchers develop way to sequence entire fetal genome by modifying prenatal testing method
March 18, 2018 - FDA Approves PDUFA Fee Waiver for Gimoti New Drug Application
March 18, 2018 - P2Y12 Tx Subsidy Yields Positive Response from Docs, Patients
March 18, 2018 - Are Proteins in Formula Linked to Type 1 Diabetes?
March 18, 2018 - Exercise does not seem to increase bone marrow edema in healthy people
March 18, 2018 - Researchers delineate architecture of nuclear pore complex in yeast cells
March 18, 2018 - ‘It’s Just Ghetto-izing People’: What We Heard This Week
March 18, 2018 - Alzheimer’s disease: Neuronal loss very limited
March 18, 2018 - Study reveals impact of intense, changing work schedules experienced by medical interns
March 18, 2018 - Jobs That Keep the Mind Sharp … Even Into Retirement
March 18, 2018 - Facial Scarring Improved with Botulinum Toxin
March 18, 2018 - Data detectives shift suspicions in Alzheimer’s to inside villain
March 18, 2018 - Shorter Preventive TB Tx Effective for HIV+ Patients
March 18, 2018 - New technique for identifying alcoholism puts treatment options at patients’ and providers’ fingertips
March 18, 2018 - Researchers uncover four microRNAs as potential biomarkers for atrial fibrillation
March 18, 2018 - IRX Therapeutics Announces Initiation of Phase 2 Clinical Trial of IRX-2 in Squamous Cervical or Vulvar Intraepithelial Neoplasia 3
March 18, 2018 - OncoBreak: Learning from Silence; ‘Rigged’ Drug System; NCCN Guidelines Questioned
March 18, 2018 - The coffee cannabis connection
March 18, 2018 - Novel centrifugal-flow pump for heart failure patients provides improved long-term outcomes
March 18, 2018 - U.S. FDA Accepts New Drug Application for Prucalopride (SHP555) for Chronic Idiopathic Constipation
March 18, 2018 - Cath Lab Recap: iFR vs FFR $$; Ridaforolimus-Eluting Stent
March 18, 2018 - Tree care workers need better training to handle dangers on the job, study finds
March 18, 2018 - Dementia patients do not undergo diagnostic evaluation at onset of disease, study finds
March 18, 2018 - Transplanting enhanced interneurons restores brain rhythms in mouse model of Alzheimer’s
March 18, 2018 - Gene Therapy Flops for Critical Limb Ischemia
March 17, 2018 - Study spotlights risks in anesthesiologist handoffs
March 17, 2018 - Verb fluency test may be useful tool for differential diagnosis of cognitive failure
March 17, 2018 - Health Tip: Suggestions to Improve Your Cholesterol
March 17, 2018 - Fructans Suspect in Non-Celiac Gluten Sensitivity
March 17, 2018 - Aspirin therapy appears safe before thyroid surgery
March 17, 2018 - Minimally invasive surgical device may one day provide lasting heart repair
March 17, 2018 - UIH and RaySearch enter into new partnership
March 17, 2018 - Is BMI Too Inexact? | Medpage Today
March 17, 2018 - Sleep apnea study finds male-female differences in cerebral cortex thickness, symptoms
March 17, 2018 - Leicester research could help identify people with asthma of different severities
March 17, 2018 - Biosense Webster enrolls and treats first AF patient in clinical study of new RF balloon catheter
March 17, 2018 - Participants in rogue herpes vaccine research take legal action
March 17, 2018 - Imara Doses First Patient in Phase 2a Clinical Trial of IMR-687 for Sickle Cell Disease
March 17, 2018 - AAP: Prevent Medication Errors by Improving Processes
March 17, 2018 - Severe sleep apnea during REM sleep tied to acute CV events
March 17, 2018 - Alzheimer’s disease also affects small blood vessels
March 17, 2018 - Jazz Pharmaceuticals Announces FDA Acceptance of NDA for Solriamfetol (JZP-110) for Excessive Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea
March 17, 2018 - Switching Biologics in Psoriasis Care
March 17, 2018 - Polygenic risk score may identify alzheimer’s risk in younger populations
March 17, 2018 - Genetic heart mutations account for fewer sudden and unexplained infant deaths
March 17, 2018 - Clinical trial to test efficacy of stem cell transplants in stopping ALS muscle deterioration
March 17, 2018 - Researchers team up to improve life for children with microcephaly
March 17, 2018 - Health guide for young women regarding labiaplasty
March 17, 2018 - Inhaled Nitrite Flops as HFpEF Therapy
March 17, 2018 - California mental health tax providing services to needy in L.A. County, study finds
March 17, 2018 - Cancer survivors become fatigued more quickly than their peers, study finds
March 17, 2018 - Study finds common presence of nightmares among U.S. military personnel
March 17, 2018 - Yellow fever outbreak in Brazil necessitates vaccination for travelers
March 17, 2018 - Health Tip: Waist Size May Help Predict Heart Attack
March 17, 2018 - Low-Dose Combo Pill Successfully Takes Down High BP
March 17, 2018 - Most children with sickle cell anemia not receiving key medication to stay healthy
March 17, 2018 - YCC launches new Yale Center for Immuno-Oncology
Wearable defibrillator reduces overall mortality, but not sudden cardiac death

Wearable defibrillator reduces overall mortality, but not sudden cardiac death

image_pdfDownload PDFimage_print

Wearing a lightweight vest equipped with a cardioverter defibrillator that detects abnormal heart rhythms in addition to taking recommended medications is associated with a reduction in the likelihood of dying during the first 90 days following a heart attack in people whose heart function was also impaired, according to a study presented at the American College of Cardiology’s 67th Annual Scientific Session. People who wore the wearable cardioverter defibrillator (WCD) during the study timeframe were 35 percent less likely to die for any reason compared with those who received medications alone.

While the study did not find a significant benefit in terms of reducing sudden cardiac death, the primary endpoint, the study did find that the wearable defibrillator was associated with fewer overall deaths.  

“It is possible that sudden deaths were misclassified as it’s difficult to define sudden death with accuracy when a death is unwitnessed and there is little documentation,” said Jeffrey E. Olgin, MD, professor and chief of cardiology, University of California San Francisco and lead author of the study. “But the cause of death is irrelevant if we can prevent it. This study found that the device was associated with fewer deaths among people recovering from a heart attack with low ejection fraction. It’s also the first therapy associated with a mortality benefit above and beyond standard medical therapy immediately after heart attack.”

The Vest Prevention of Early Sudden Death Trial (VEST) is the first randomized, controlled, multi-center trial of the wearable cardioverter defibrillator. It was designed to test whether this device could effectively reduce sudden death in patients who had recently suffered a heart attack and had reduced heart function (defined as a low ejection fraction of 35 percent or less) where the heart wasn’t able to pump sufficient blood to the rest of the body, which is indicative of a sizable heart attack.

Generally, the three-month mortality rate for people recovering from a heart attack who also have reduced heart function is around 5 percent, Olgin said, and that is with optimal medical management. Similarly, in VEST, 4.9 percent of participants in the control group died compared with only 3.2 percent of those wearing the WCD—an absolute difference of 1.7 percent.  

“There is a very high risk of death immediately after a heart attack that tails off after about three months,” Olgin said. “The challenge is that we don’t currently have a good way of preventing deaths during this very vulnerable period.”

Despite the high rate of sudden death in the months following a heart attack, implantable cardioverter defibrillators (ICDs) placed in the chest aren’t currently indicated for this patient population before 40-90 days for several reasons. First, large studies have failed to show that implanting an ICD during this period results in long-term reductions in mortality. Second, in many cases someone’s ejection fraction will improve in the ensuing months post-heart attack. In VEST, for example, 60 percent of people with low ejection fraction in the first three months after heart attack recovered and no longer met the criteria for an ICD at 90 days. Lastly, there is competing risk of death from other causes not preventable with a defibrillator—for example, another heart attack or cardiac rupture.

According to Olgin, these new findings suggest WCDs could fill the gap in cardiac therapy until patients can be evaluated for an ICD. Current guidelines recommend the WCD as a potential tool that practitioners can use, but the researchers believe findings from this large randomized trial will add important data to further inform these guideline recommendations.

The LifeVest WCD is worn under clothing, directly against the skin and works by continuously monitoring a patient’s heart and sounding alarms and/or giving verbal commands to encourage people to seek medical care, if needed. If a life-threatening heart rhythm is detected, the device delivers a shock to restore a normal heart rhythm.

“What’s nice about the wearable defibrillator is that it’s non-invasive and it’s not permanent,” Olgin said. “Based on our results, I think we’ll see more widespread use of this device in these patients.”

The trial enrolled 2,300 adult patients admitted to the hospital for heart attack with an ejection fraction of ≤ 35 percent across more than 100 trial sites in four countries. Upon discharge, patients were randomized 2 to 1 to either receive the WCD plus guideline-directed medical therapy or guideline-directed medical therapy alone for 90 days to determine the potential mortality benefit of the WCD.

Patients were advised and reminded to wear the WCD as much as possible and only take it off for bathing; participants who wore the WCD did so for an average of 21 hours a day. The primary outcome was sudden death at three months and secondary outcomes were total and cause-specific mortality, non-fatal ventricular arrhythmias and hospitalizations. Participants and sites were not blinded to the treatment arm, but they were blinded to any arrhythmia detections during the follow-up. Un-blinding could be requested if a participant had a shock, cardiac arrest or syncopal event. Outcomes were adjudicated by an independent, blinded panel.

The vast majority of patients in both groups—upwards of 85 percent—received appropriate guideline-directed treatment for post-heart attack management, as well as heart failure management given patients’ reduced ejection fraction. At the end of the study, researchers searched the National Death Index for participants lost to follow up. The rate of cardiovascular-related re-hospitalizations was 25 percent and was similar in both groups.

The study was originally designed with a primary outcome of total mortality. However, because of enrollment difficulties early in the study, the estimated sample size of 4,500 participants became infeasible. After the first 213 participants were enrolled in 2010, the primary outcome was changed to sudden death with a pre-specified secondary outcome of total mortality, Olgin said.

He and his team are working on a number of additional analyses from this study. They also plan on transitioning patients into a registry for longer-term follow up.

Tagged with:

About author

Related Articles