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Archive for the ‘Frontiers in Cardiology and Cardiovascular Disorders’ Category


Cardiovascular (CV) Disease and Diabetes: New ACC Guidelines for use of two major new classes of diabetes drugs — sodium-glucose cotransporter type 2 (SGLT2) inhibitors and glucagon-like peptide 1 receptor agonists (GLP-1RAs) for reduction of adverse outcomes

Reporter: Aviva Lev-Ari, PhD, RN

 

“The main aim for this report is to educate cardiologists, who might not otherwise think about prescribing diabetes drugs, about these two new classes of medications that have important cardiovascular benefits for their patients,” cochair of the writing committee for the new consensus document, Brendan Everett, MD, assistant professor of medicine, Brigham and Women’s Hospital, Boston, commented to theheart.org | Medscape Cardiology.

We hope to help them understand which of their patients might benefit, and to help them understand how to prescribe these new drugs appropriately to their patients with both atherosclerotic cardiovascular disease and diabetes.”

The document is published online November 26 in the Journal of the American College of Cardiology, and is endorsed by the American Diabetes Association.

Journal of the American College of Cardiology

2018 ACC Expert Consensus Decision Pathway on Novel Therapies for Cardiovascular Risk Reduction in Patients With Type 2 Diabetes and Atherosclerotic Cardiovascular Disease

A Report of the American College of Cardiology Task Force on Expert Consensus Decision Pathways Writing Committee: 

4 Pathway Summary Graphic

Figure 1 provides an overview of what is covered in the Expert Consensus Decision Pathway. See each section for more detailed considerations and guidance.

Figure 1

Summary Graphic

Figure 2 offers 1 approach to deciding which drug to use in which patient, Table 11 outlines patient and clinician preferences to consider when selecting an SGLT2 inhibitor or GLP-1RA. Table 12 provides an overview of considerations for initiating and monitoring an SGLT2 inhibitor. Table 13 provides an overview of considerations for initiating and monitoring a GLP-1RA.

Figure 2

Approach to Managing Patients With Established ASCVD and T2D

SOURCE

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VIDEO: Editor’s Choice of the Most Innovative New Cardiac Technology at AHA 2018

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Heart Murmur Detection done by AI Algorithm (Eko Core and Eko Duo) Devices Outperform most Auscultatory Skills of Cardiologists

Reporter: Aviva Lev-Ari, PhD, RN

 

AI Algorithm Outperforms Most Cardiologists in Heart Murmur Detection

Eko’s heart murmur detection algorithm outperformed four out of five cardiologists in recent clinical study

“Artificial Intelligence Detects Pediatric Heart Murmurs With Cardiologist-Level Accuracy,” the study demonstrates the power of machine learning and artificial intelligence (AI) to enhance cardiac care.

The neural network AI algorithm was trained on thousands of heart sound recordings. The algorithm was then tested on an independent dataset of pediatric heart sounds and compared to gold-standard echocardiogram imagery. Five pediatric cardiologists also listened to the heart sound recordings and independently made a determination whether a recording contained a murmur. This advancement will help narrow the clinical skill gap between the 27,000 cardiologists in the U.S. — the experts at murmur detection — and the 3.8 million other clinicians who are less experienced in the identification of heart murmurs through a stethoscope.

A study published in the Journal of the American Medical Association revealed that, on average, internal medicine and family practice physician residents misdiagnose 80 percent of common cardiac events.1 Cardiologists on the other hand, can effectively diagnose 90 percent of cardiac events using a stethoscope.2

Eko’s murmur screening algorithm, when coupled with the company’s U.S. Food and Drug Administration (FDA)-cleared Eko Core and Eko Duo devices, will enable any and all clinicians to more accurately screen for heart murmurs.

Eko is currently pursuing FDA clearance for the algorithm and will be rolling it out with its existing cardiac monitoring devices upon securing regulatory clearance.

For more information: http://www.ekohealth.com

References

1. Mangione S., Nieman L.Z. Cardiac auscultatory skills of internal medicine and family practice trainees. A comparison of diagnostic proficiency. Journal of the American Medical Association, Sept. 3, 1997. doi:10.1001/jama.1997.03550090041030

2. Thompson W.R. In defence of auscultation: a glorious future? Heart Asia, Feb. 1, 2017. doi:  [10.1136/heartasia-2016-010796]

 

SOURCE

https://www.dicardiology.com/content/ai-algorithm-outperforms-most-cardiologists-heart-murmur-detection?eid=333021707&bid=2308309

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Individuals without angiographic CAD but with hiPRS remain at significantly elevated risk of mortality after cardiac catheterization

Reporter: Aviva Lev-Ari, PhD, RN

 

A genome-wide Polygenic risk scores (PRS) improves risk stratification when added to traditional risk factors and coronary angiography. Individuals without angiographic CAD but with hiPRS remain at significantly elevated risk of mortality.

 

Background:

Coronary artery disease (CAD) is influenced by genetic variation and traditional risk factors. Polygenic risk scores (PRS), which can be ascertained before the development of traditional risk factors, have been shown to identify individuals at elevated risk of CAD. Here, we demonstrate that a genome-wide PRS for CAD predicts all-cause mortality after accounting for not only traditional cardiovascular risk factors but also angiographic CAD itself.

Methods:

Individuals who underwent coronary angiography and were enrolled in an institutional biobank were included; those with prior myocardial infarction or heart transplant were excluded. Using a pruning-and-thresholding approach, a genome-wide PRS comprised of 139 239 variants was calculated for 1503 participants who underwent coronary angiography and genotyping. Individuals were categorized into high PRS (hiPRS) and low-PRS control groups using the maximally selected rank statistic. Stratified analysis based on angiographic findings was also performed. The primary outcome was all-cause mortality following the index coronary angiogram.

Results:

Individuals with hiPRS were younger than controls (66 years versus 69 years; P=2.1×10-5) but did not differ by sex, body mass index, or traditional risk-factor profiles. Individuals with hiPRS were at significantly increased risk of all-cause mortality after cardiac catheterization, adjusting for traditional risk factors and angiographic extent of CAD (hazard ratio, 1.6; 95% CI, 1.2–2.2; P=0.004). The strongest increase in risk of all-cause mortality conferred by hiPRS was seen among individuals without angiographic CAD (hazard ratio, 2.4; 95% CI, 1.1–5.5; P=0.04). In the overall cohort, adding hiPRS to traditional risk assessment improved prediction of 5-year all-cause mortality (area under the receiver-operating curve 0.70; 95% CI, 0.66–0.75 versus 0.66; 95% CI, 0.61–0.70; P=0.001).

Conclusions:

A genome-wide PRS improves risk stratification when added to traditional risk factors and coronary angiography. Individuals without angiographic CAD but with hiPRS remain at significantly elevated risk of mortality.

Footnotes

https://www.ahajournals.org/journal/circgen

*A list of all Regeneron Genetics Center members is given in the Data Supplement.

Guest Editor for this article was Christopher Semsarian, MBBS, PhD, MPH.

The Data Supplement is available at https://www.ahajournals.org/doi/suppl/10.1161/CIRCGEN.118.002352.

Scott M. Damrauer, MD, Department of Surgery, Hospital of the University of Pennsylvania, 3400 Spruce St, Silverstein 4, Philadelphia, PA 19104. Email 
SOURCE
https://www.ahajournals.org/doi/10.1161/CIRCGEN.118.002352

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The HFE H63D variant confers an increased risk for hypertension, no increased risk for adverse cardiovascular events or substantial left ventricular remodeling

Reporter: Aviva Lev-Ari, PhD, RN

Conclusion:

The HFE H63D variant confers an increased risk for hypertension per allele and, given its frequency, accounts for a significant number of cases of hypertension. However, there was no increased risk for adverse cardiovascular events or substantial left ventricular remodeling.

 

HFE H63D Polymorphism and the Risk for Systemic Hypertension, Myocardial Remodeling, and Adverse Cardiovascular Events in the ARIC Study

Originally publishedHypertension. 2018;0:HYPERTENSIONAHA.118.11730

H63D has been identified as a novel locus associated with the development of hypertension. The quantitative risks for hypertension, cardiac remodeling, and adverse events are not well studied. We analyzed white participants from the ARIC study (Atherosclerosis Risk in Communities) with H63D genotyping (N=10 902). We related genotype status to prevalence of hypertension at each of 5 study visits and risk for adverse cardiovascular events. Among visit 5 participants (N=4507), we related genotype status to echocardiographic features. Frequencies of wild type (WT)/WT, H63D/WT, and H63D/H63D were 73%, 24.6%, and 2.4%. The average age at baseline was 54.9±5.7 years and 47% were men. Participants carrying the H63D variant had higher systolic blood pressure (P=0.004), diastolic blood pressure (0.012), and more frequently had hypertension (P<0.001). Compared with WT/WT, H63D/WT and H63D/H63D participants had a 2% to 4% and 4% to 7% absolute increase in hypertension risk at each visit, respectively. The population attributable risk of H63D for hypertension among individuals aged 45 to 64 was 3.2% (95% CI, 1.3–5.1%) and 1.3% (95% CI, 0.0–2.4%) among individuals >65 years. After 25 years of follow-up, there was no relationship between genotype status and any outcome (P>0.05). H63D/WT and H63D/H63D genotypes were associated with small differences in cardiac remodeling. In conclusion, the HFE H63D variant confers an increased risk for hypertension per allele and, given its frequency, accounts for a significant number of cases of hypertension. However, there was no increased risk for adverse cardiovascular events or substantial left ventricular remodeling.

Footnotes

The online-only Data Supplement is available with this article at https://www.ahajournals.org/doi/suppl/10.1161/HYPERTENSIONAHA.118.11730.

Correspondence to Scott D. Solomon, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, 75 Francis St, Boston, MA 02115. Email 

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NHLBI decision to halt Heart Stem-Cell Study (CONCERT-HF trial) due to concerns about Anversa’s Animal Studies, not due to any Data generated by the Clinical trial itself, no compromised patient safety by trial

Reporter: Aviva Lev-Ari, PhD, RN

Doubts about Anversa’s work arose in the early 2000s after other researchers failed to replicate his findings and questioned whether cardiac stem cells existed2,3,4.

Paper of Former HMS Prof. Withdrawn, Clinical Trial Paused after Harvard Requests Retractions

https://www.thecrimson.com/article/2018/10/31/medical-school-paper-retracted/

NHLBI NEWS

Statement

Statement on NHLBI decision to pause the CONCERT-HF trial

The National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health, is pausing the CONCERT-HF trialexternal link, which involves patients with chronic heart failure. Recent calls for the retraction of journal articles in related fields of cell therapy research have raised concerns about the scientific foundations of this trial.  While none of the articles in question derive from the CONCERT-HF trial itself, the NHLBI convened CONCERT-HF’s Data and Safety Monitoring Board (DSMB) out of an abundance of caution to ensure the study continues to meet the highest standards for participant safety and scientific integrity. Informed by the DSMB recommendations of October 25, 2018, the NHLBI is pausing the trial. While the DSMB did not have any participant safety concerns, this pause enables the DSMB to complete its review.

The safety of all clinical trial participants is paramount to NHLBI. NHLBI will honor its commitment to CONCERT-HF participants and continue the follow-up protocol during this pause for all participants who have already been treated in the study. Participants are being notified of the status of the trial and how to request additional information.

The CONCERT-HF trial seeks to determine whether c-kit+ cells, either alone or in combination with mesenchymal stem cells derived from the bone marrow, are safe and benefit patients with chronic heart failure, who have very limited treatment options. Despite significant medical and surgical advances, patients with heart failure continue to experience a low quality of life and about half of them will die within five years of receiving a diagnosis.

The scientific basis of CONCERT-HF is supported by a body of evidence in several preclinical models in a number of studies in a variety of laboratories and was reviewed by a Protocol Review Committee (PRC) independent of the trial. The cell therapies that CONCERT-HF is testing are under an investigational new drug (IND) designation which is overseen by the U.S. Food and Drug Administration (FDA). The cells are produced by an accredited laboratory independent of the clinical sites. In addition, as part of standard oversight of clinical trials, the DSMB routinely reviews and monitors CONCERT-HF to ensure participant safety and that the study continues to ask compelling scientific questions with implications for patient care.

The DSMB’s review will be conducted as expeditiously as possible and will inform NHLBI’s future actions that will ensure the highest standards of participant safety and scientific integrity.

SOURCE

https://www.nhlbi.nih.gov/news/2018/statement-nhlbi-decision-pause-concert-hf-trial

References

  1. Quaini, F. et al. N. Engl. J. Med. 346, 5–15 (2002).
  1. Murry, C. E. et al. Nature 428, 664–668 (2004).
  1. Balsam, L. B. Nature 428, 668–673 (2004).
  1. Nygren, J. M. et al. Nature Med. 10, 494–501 (2004).

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Cardiac Medical Devices Pioneer, Earl E. Bakken, Medtronic Co-founder, the developer of the first external, battery-powered, transistorized pacemaker, died at 94 on 10/21/2018 in Hawaii

Reporter: Aviva Lev-Ari, PhD, RN

 

Earl Bakken was born to Florence and Osval Bakken on January 10, 1924, in Minneapolis. After serving as a radar instructor in World War II, Bakken earned a degree in electrical engineering at the University of Minnesota.

In the late 1950’s, Bakken developed the first external, wearable, battery-powered, transistorized heart pacemaker, and commercialized the first implantable pacemaker in 1960. Medtronic grew rapidly from there; today its medical products and devices improve the lives of two people every second.

Earl with five-year-old pacemaker recipient Lyla Koch in 1984

Image Sourcehttp://www.medtronic.com/us-en/about/news/celebrating-earl-bakken.html

CELEBRATING EARL BAKKEN

Legendary Medtronic co-founder passes away in Hawaii.

Earl Bakken, Co-founder, Medtronic, died at 94

Image Sourcehttp://www.medtronic.com/us-en/about/news/celebrating-earl-bakken.html

The business struggled, but while servicing medical equipment, Bakken and Hermundslie built relationships with doctors at university hospitals in Minneapolis. There they met C. Walton Lillehei, a young staff surgeon who would later become famous for pioneering open-heart surgery. Following a blackout in the Twin Cities that caused the death of an infant, Lillehei asked Bakken to come up with a solution. He responded by adapting a circuit described in Popular Electronics magazine to create the first external wearable, battery-powered pacemaker, replacing the large, alternating current-powered pacemakers that were in use at the time.

The original Medtronic "Garage Gang" poses in front of Medtronic Operational Headquarters in Fridley, Minnesota.

The Garage Gang

Standing: Dale Blosberg, Norman Hagfors, Earl Hatten. Seated: John Bravis, Earl Bakken, Louis Leisch

They expanded services to other medical technology. Then in 1960, the first implantable pacemaker was implanted in a human patient. Bakken and Hermundslie reached a licensing agreement with the inventors, giving their small company exclusive manufacturing and marketing rights to the device, and Medtronic took off.

“Earl always had a vision of healthcare of not being about devices, about drugs, but about restoring people to full health,” said former Medtronic CEO Bill George. “And so from the very start he was focused on not implanting a device, but enabling people to live a full active life and he delivered that point of view to all Medtronic employees through The Mission.

A lifelong aspiration came true for Bakken in 2013, when Medtronic Philanthropy launched The Bakken Invitation to honor people who received medical devices, and who made an impact on the lives of others, through service and volunteerism. Bakken, who in his later years became a medical device patient, with a pacemaker, coronary stents and insulin pump, was fond of asking patients what they planned to do with their gift of “extra life.” Each year Bakken met with the honorees. “Their stories are a powerful reminder that we can all give back-no matter our current situation,” he said after meeting them in 2014.

Earl poses with recipients of the Bakken Invitation in 2013.Earl with Bakken Invitation recipients in 2013

Every year in December, Medtronic employees gather to mark another Bakken inspiration — the employee holiday program. The company invites patients from all over the world to share their stories of how medical technology has improved their lives. Hundreds of employees fill the Medtronic conservatory for the event, while thousands of others listen or watch via Medtronic TV.

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