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Eight Subcellular Pathologies driving Chronic Metabolic Diseases – Methods for Mapping Bioelectronic Adjustable Measurements as potential new Therapeutics: Impact on Pharmaceuticals in Use

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Eight Subcellular Pathologies driving Chronic Metabolic Diseases – Methods for Mapping Bioelectronic Adjustable Measurements as potential new Therapeutics: Impact on Pharmaceuticals in Use

Curators:

• Cardiovascular Expertise – Dr. Justin D. Pearlman, MD, PhD, FACC
• Pharmacology and Oncology Expertise – Dr. Stephen J. Williams, PhD
• Principal Investigator, initiator of the project – Aviva Lev-Ari, PhD, RN

 

THE VOICE of Aviva Lev-Ari, PhD, RN

In this curation we wish to present two breaking through goals:

Goal 1:

Exposition of a new direction of research leading to a more comprehensive understanding of Metabolic Dysfunctional Diseases that are implicated in effecting the emergence of the two leading causes of human mortality in the World in 2023: (a) Cardiovascular Diseases, and (b) Cancer

Goal 2:

Development of Methods for Mapping Bioelectronic Adjustable Measurements as potential new Therapeutics for these eight subcellular causes of chronic metabolic diseases. It is anticipated that it will have a potential impact on the future of Pharmaceuticals to be used, a change from the present time current treatment protocols for Metabolic Dysfunctional Diseases.

According to Dr. Robert Lustig, M.D, an American pediatric endocrinologist. He is Professor emeritus of Pediatrics in the Division of Endocrinology at the University of California, San Francisco, where he specialized in neuroendocrinology and childhood obesity, there are eight subcellular pathologies that drive chronic metabolic diseases.

These eight subcellular pathologies can’t be measured at present time.

In this curation we will attempt to explore methods of measurement for each of these eight pathologies by harnessing the promise of the emerging field known as Bioelectronics.

Unmeasurable eight subcellular pathologies that drive chronic metabolic diseases

1. Glycation
2. Oxidative Stress
3. Mitochondrial dysfunction [beta-oxidation Ac CoA malonyl fatty acid]
4. Insulin resistance/sensitive [more important than BMI], known as a driver to cancer development
5. Membrane instability
6. Inflammation in the gut [mucin layer and tight junctions]
7. Epigenetics/Methylation
8. Autophagy [AMPKbeta1 improvement in health span]

Diseases that are not Diseases: no drugs for them, only diet modification will help

Image source

Robert Lustig, M.D. on the Subcellular Processes That Belie Chronic Disease

https://www.youtube.com/watch?v=Ee_uoxuQo0I

 

Exercise will not undo Unhealthy Diet

Image source

Robert Lustig, M.D. on the Subcellular Processes That Belie Chronic Disease

https://www.youtube.com/watch?v=Ee_uoxuQo0I

 

These eight Subcellular Pathologies driving Chronic Metabolic Diseases are becoming our focus for exploration of the promise of Bioelectronics for two pursuits:

1. Will Bioelectronics be deemed helpful in measurement of each of the eight pathological processes that underlie and that drive the chronic metabolic syndrome(s) and disease(s)?
2. IF we will be able to suggest new measurements to currently unmeasurable health harming processes THEN we will attempt to conceptualize new therapeutic targets and new modalities for therapeutics delivery – WE ARE HOPEFUL

In the Bioelecronics domain we are inspired by the work of the following three research sources:

1. Biological and Biomedical Electrical Engineering (B2E2) at Cornell University, School of Engineering https://www.engineering.cornell.edu/bio-electrical-engineering-0
2. Bioelectronics Group at MIT https://bioelectronics.mit.edu/
3. The work of Michael Levin @Tufts, The Levin Lab

Michael Levin is an American developmental and synthetic biologist at Tufts University, where he is the Vannevar Bush Distinguished Professor. Levin is a director of the Allen Discovery Center at Tufts University and Tufts Center for Regenerative and Developmental Biology. Wikipedia

Born: 1969 (age 54 years), Moscow, Russia

Education: Harvard University (1992–1996), Tufts University (1988–1992)

Affiliation: University of Cape Town

Research interests: Allergy, Immunology, Cross Cultural Communication

Awards: Cozzarelli prize (2020)

Doctoral advisor: Clifford Tabin

Fields: Developmental biology, synthetic biology

SOURCE

https://www.google.com/search?q=Michael+Levin+%40Tufts&oq=Michael+Levin+%40Tufts&aqs=chrome..69i57j69i58.894128314j0j15&sourceid=chrome&ie=UTF-8

Most recent 20 Publications by Michael Levin, PhD

SOURCE

https://facultyprofiles.tufts.edu/michael-levin-1/publications

SCHOLARLY ARTICLE

The nonlinearity of regulation in biological networks

1 Dec 2023npj Systems Biology and Applications9(1)

Co-authorsManicka S, Johnson K, Levin M…1 more

VIEW PDF10.1038/S41540-023-00273-W

3

SCHOLARLY ARTICLE

Toward an ethics of autopoietic technology: Stress, care, and intelligence

1 Sep 2023BioSystems231

Co-authorsWitkowski O, Doctor T, Solomonova E…2 more

VIEW PDF10.1016/J.BIOSYSTEMS.2023.104964

SCHOLARLY ARTICLE

Closing the Loop on Morphogenesis: A Mathematical Model of Morphogenesis by Closed-Loop Reaction-Diffusion

14 Aug 2023Frontiers in Cell and Developmental Biology11:1087650

Co-authorsGrodstein J, McMillen P, Levin M

VIEW PDF10.3389/FCELL.2023.1087650

SCHOLARLY ARTICLE

Correcting instructive electric potential patterns in multicellular systems: External actions and endogenous processes.

30 Jul 2023Biochim Biophys Acta Gen Subj1867(10):130440

Co-authorsCervera J, Levin M, Mafe S

VIEW MORE INFO10.1016/J.BBAGEN.2023.130440

SCHOLARLY ARTICLE

Regulative development as a model for origin of life and artificial life studies

1 Jul 2023BioSystems229

Co-authorsFields C, Levin M

10.1016/J.BIOSYSTEMS.2023.104927

1

SCHOLARLY ARTICLE

The Yin and Yang of Breast Cancer: Ion Channels as Determinants of Left–Right Functional Differences

1 Jul 2023International Journal of Molecular Sciences24(13)

Co-authorsMasuelli S, Real S, McMillen P…3 more

VIEW PDF10.3390/IJMS241311121

SCHOLARLY ARTICLE

Bioelectricidad en agregados multicelulares de células no excitables- modelos biofísicos

Jun 2023Revista Española de Física32(2)

Co-authorsCervera J, Levin M, Mafé S

SCHOLARLY ARTICLE

Bioelectricity: A Multifaceted Discipline, and a Multifaceted Issue!

1 Jun 2023Bioelectricity5(2):75

Co-authorsDjamgoz MBA, Levin M

10.1089/BIOE.2023.0022.EDITORIAL

SCHOLARLY ARTICLE

Control Flow in Active Inference Systems – Part I: Classical and Quantum Formulations of Active Inference

1 Jun 2023IEEE Transactions on Molecular, Biological, and Multi-Scale Communications9(2):235-245

Co-authorsFields C, Fabrocini F, Friston K…4 more

10.1109/TMBMC.2023.3272150

2

SCHOLARLY ARTICLE

Control Flow in Active Inference Systems – Part II: Tensor Networks as General Models of Control Flow

1 Jun 2023IEEE Transactions on Molecular, Biological, and Multi-Scale Communications9(2):246-256

Co-authorsFields C, Fabrocini F, Friston K…4 more

10.1109/TMBMC.2023.3272158

2

SCHOLARLY ARTICLE

Darwin’s agential materials: evolutionary implications of multiscale competency in developmental biology

1 Jun 2023Cellular and Molecular Life Sciences80(6)

Co-authorsLevin M

VIEW PDF10.1007/S00018-023-04790-Z

1

SCHOLARLY ARTICLE

Morphoceuticals: Perspectives for discovery of drugs targeting anatomical control mechanisms in regenerative medicine, cancer and aging

1 Jun 2023Drug Discovery Today28(6)

Co-authorsPio-Lopez L, Levin M

VIEW PDF10.1016/J.DRUDIS.2023.103585

1

SCHOLARLY ARTICLE

Morphoceuticals: Perspectives for discovery of drugs targeting anatomical control mechanisms in regenerative medicine, cancer and aging

Jun 2023DRUG DISCOVERY TODAY28(6):1-13

Co-authorsPio-Lopez L, Levin M

VIEW MORE INFO10.1016/J.DRUDIS.2023.103585THIS

SCHOLARLY ARTICLE

Cellular signaling pathways as plastic, proto-cognitive systems: Implications for biomedicine

12 May 2023Patterns4(5)

Co-authorsMathews J, Chang A, Devlin L…1 more

VIEW PDF10.1016/J.PATTER.2023.100737

3

SCHOLARLY ARTICLE

Making and breaking symmetries in mind and life

14 Apr 2023Interface Focus13(3)

Co-authorsSafron A, Sakthivadivel DAR, Sheikhbahaee Z…3 more

VIEW PDF10.1098/RSFS.2023.0015

SCHOLARLY ARTICLE

The scaling of goals from cellular to anatomical homeostasis: an evolutionary simulation, experiment and analysis

14 Apr 2023Interface Focus13(3)

Co-authorsPio-Lopez L, Bischof J, LaPalme JV…1 more

VIEW PDF10.1098/RSFS.2022.0072

1

SCHOLARLY ARTICLE

The collective intelligence of evolution and development

Apr 2023Collective Intelligence2(2):263391372311683SAGE Publications

Co-authorsWatson R, Levin M

VIEW PDF10.1177/26339137231168355

SCHOLARLY ARTICLE

Bioelectricity of non-excitable cells and multicellular pattern memories: Biophysical modeling

13 Mar 2023Physics Reports1004:1-31

Co-authorsCervera J, Levin M, Mafe S

10.1016/J.PHYSREP.2022.12.003

2

SCHOLARLY ARTICLE

There’s Plenty of Room Right Here: Biological Systems as Evolved, Overloaded, Multi-Scale Machines

1 Mar 2023Biomimetics8(1)

Co-authorsBongard J, Levin M

VIEW PDF10.3390/BIOMIMETICS8010110

4

SCHOLARLY ARTICLE

Transplantation of fragments from different planaria: A bioelectrical model for head regeneration

7 Feb 2023Journal of Theoretical Biology558

Co-authorsCervera J, Manzanares JA, Levin M…1 more

VIEW PDF10.1016/J.JTBI.2022.111356

SCHOLARLY ARTICLE

Bioelectric networks: the cognitive glue enabling evolutionary scaling from physiology to mind

1 Jan 2023Animal Cognition

Co-authorsLevin M

VIEW PDF10.1007/S10071-023-01780-3

2

SCHOLARLY ARTICLE

Biological Robots: Perspectives on an Emerging Interdisciplinary Field

1 Jan 2023Soft Robotics

Co-authorsBlackiston D, Kriegman S, Bongard J…1 more

10.1089/SORO.2022.0142

1

SCHOLARLY ARTICLE

Cellular Competency during Development Alters Evolutionary Dynamics in an Artificial Embryogeny Model

1 Jan 2023Entropy25(1)

Co-authorsShreesha L, Levin M

VIEW PDF10.3390/E25010131

5

SCHOLARLY ARTICLE

Endless forms most beautiful 2.0: teleonomy and the bioengineering of chimaeric and synthetic organisms (July, blac073, 2022)

1 Jan 2023BIOLOGICAL JOURNAL OF THE LINNEAN SOCIETY138(1):141

Co-authorsClawson WP, Levin M

VIEW PDFVIEW MORE INFO10.1093/BIOLINNEAN/BLAC116

SCHOLARLY ARTICLE

Future medicine: from molecular pathways to the collective intelligence of the body

1 Jan 2023Trends in Molecular Medicine

Co-authorsLagasse E, Levin M

10.1016/J.MOLMED.2023.06.007

THE VOICE of Dr. Justin D. Pearlman, MD, PhD, FACC

PENDING

THE VOICE of  Stephen J. Williams, PhD

Ten TakeAway Points of Dr. Lustig’s talk on role of diet on the incidence of Type II Diabetes

 

1. 25% of US children have fatty liver
2. Type II diabetes can be manifested from fatty live with 151 million  people worldwide affected moving up to 568 million in 7 years
3. A common myth is diabetes due to overweight condition driving the metabolic disease
4. There is a trend of ‘lean’ diabetes or diabetes in lean people, therefore body mass index not a reliable biomarker for risk for diabetes
5. Thirty percent of ‘obese’ people just have high subcutaneous fat.  the visceral fat is more problematic
6. there are people who are ‘fat’ but insulin sensitive while have growth hormone receptor defects.  Points to other issues related to metabolic state other than insulin and potentially the insulin like growth factors
7. At any BMI some patients are insulin sensitive while some resistant
8. Visceral fat accumulation may be more due to chronic stress condition
9. Fructose can decrease liver mitochondrial function
10. A methionine and choline deficient diet can lead to rapid NASH development

 

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Experimental Therapy (Left inter-atrial shunt implant device) for Heart Failure: Expert Opinion on a Preliminary Study on Heart Failure with preserved Ejection Fraction 

Posted in congestive heart failure, Frontiers in Cardiology and Cardiovascular Disorders, Heart Failure (HF), Mechanical Assist Devices: LVAD, RVAD, BiVAD, Artificial Heart, Medical Devices R&D and Inventions, Origins of Cardiovascular Disease on May 9, 2018| 1 Comment »

Experimental Therapy (Left inter-atrial shunt implant device) for Heart Failure: Expert Opinion on a Preliminary Study on Heart Failure with preserved Ejection Fraction 

Article Curator: Aviva Lev-Ari, PhD, RN

UPDATED on 5/11/2022

For heart failure patients with mildly reduced or preserved ejection fraction in the DELIVER trial, dapagliflozin (Farxiga) helped reduce the risk of cardiovascular death and worsening heart failure, AstraZeneca announced, paving the way for a new indication in the future.

But how many real-world heart failure patients would actually be eligible for SGLT2 inhibitors based on trial criteria? (Journal of Cardiac Failure)

SOURCE

https://www.medpagetoday.com/cardiology/prevention/98631?xid=nl_mpt_DHE_2022-05-10&eun=g99985d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=Daily%20Headlines%20Evening%202022-05-10&utm_term=NL_Daily_DHE_dual-gmail-definition

UPDATED on 8/28/2021

Empagliflozin in Heart Failure with a Preserved Ejection Fraction

List of authors.

• Stefan D. Anker, M.D., Ph.D.,
• Javed Butler, M.D.,
• Gerasimos Filippatos, M.D., Ph.D.,
• João P. Ferreira, M.D.,
• Edimar Bocchi, M.D.,
• Michael Böhm, M.D., Ph.D.,
• Hans-Peter Brunner–La Rocca, M.D.,
• Dong-Ju Choi, M.D.,
• Vijay Chopra, M.D.,
• Eduardo Chuquiure-Valenzuela, M.D.,
• Nadia Giannetti, M.D.,
• Juan Esteban Gomez-Mesa, M.D.,
• et al.,
•  for the EMPEROR-Preserved Trial Investigators^*

Abstract

BACKGROUND

Sodium–glucose cotransporter 2 inhibitors reduce the risk of hospitalization for heart failure in patients with heart failure and a reduced ejection fraction, but their effects in patients with heart failure and a preserved ejection fraction are uncertain.

METHODS

In this double-blind trial, we randomly assigned 5988 patients with class II–IV heart failure and an ejection fraction of more than 40% to receive empagliflozin (10 mg once daily) or placebo, in addition to usual therapy. The primary outcome was a composite of cardiovascular death or hospitalization for heart failure.

RESULTS

Over a median of 26.2 months, a primary outcome event occurred in 415 of 2997 patients (13.8%) in the empagliflozin group and in 511 of 2991 patients (17.1%) in the placebo group (hazard ratio, 0.79; 95% confidence interval [CI], 0.69 to 0.90; P<0.001). This effect was mainly related to a lower risk of hospitalization for heart failure in the empagliflozin group. The effects of empagliflozin appeared consistent in patients with or without diabetes. The total number of hospitalizations for heart failure was lower in the empagliflozin group than in the placebo group (407 with empagliflozin and 541 with placebo; hazard ratio, 0.73; 95% CI, 0.61 to 0.88; P<0.001). Uncomplicated genital and urinary tract infections and hypotension were reported more frequently with empagliflozin.

CONCLUSIONS

Empagliflozin reduced the combined risk of cardiovascular death or hospitalization for heart failure in patients with heart failure and a preserved ejection fraction, regardless of the presence or absence of diabetes. (Funded by Boehringer Ingelheim and Eli Lilly; EMPEROR-Preserved ClinicalTrials.gov number, NCT03057951. opens in new tab).

SOURCE

August 27, 2021
DOI: 10.1056/NEJMoa2107038

https://www.nejm.org/doi/full/10.1056/NEJMoa2107038

UPDATED on 2/12/2019

Almost 25% of HFrEF patients prescribed drugs that could worsen their condition

February 11, 2019 | Anicka Slachta | Heart Failure

Prescription of Potentially Harmful Drugs in Young Adults With Heart Failure and Reduced Ejection Fraction

Paulino A. Alvarez, MDCorrespondence information about the author MD Paulino A. AlvarezEmail the author MD Paulino A. AlvarezEmail the author MD Paulino A. Alvarez

,

Chau N Truong, MPH

,

Alexandros Briasoulis, MD PhD

,

Cecilia Ganduglia-Cazaban, MD PhD

DOI: https://doi.org/10.1016/j.amjcard.2019.01.052

The Voice of Dr. Justin D. Pearlman

The selection of medications for patients with multiple conditions (co-morbidities) always raises conflicts. This is true in general, and especially true for patients with heart failure. 

For example, patients with heart failure with reduced ejection fraction (HFrEF) have increased risk of atrial fibrillation, whereby sustained rapid ventricular response may worsen the failure due to tachycardiomyopathy. In essence, sustained high heatrates deplete supplies and weaken the heart, which can take months of controlled rates to recover.  

Medications to control the rate are problematic. Digoxin increases the death rate. Beta blockers and diltiazem decrease the heartrate but also decrease contractility (EF), and in combination may stop the heart (complete heart clock, cardiac arrest). Anti-arrhythmic agents also decrease contractility. Use of beta blockers is encouraged because benefits often outweigh the harm, though in some cases the decline in contractility results in unacceptably low blood pressure. Some patients with rate control issues do not tolerate beta blockers but do better on diltiazem instead. Thus the list of medications that may worsen heart failure constitute “relative contraindications” which means concerning but still possibly useful. 

In other words, some of the medications that may worsen ejection fraction have net benefit, and may be used with caution. 

Non-steroidal anti inflammatory agents (NSAIDs) are another example.  They relieve pain and add function to patients limited by arthritis.  High dose ibuprofen tapered over one month can stop pericarditis, as an alternative to colchicine which may be limited by causing intractable diarrhea. Nonsteroidal anti-inflammatory drugs (NSAIDs) decrease prostaglandin synthesis and, thus, may precipitate fluid retention in patients with heart failure. They also increase blood pressure, impair renal function and promote thrombosis (clotting). Use of NSAIDS has not been shown to curtail joint damage to joints, and daily use for 18 months or more promotes coronary disease. Overall, NSAIDs appear to be over utilized. 

The high incidence of use of medications that may cause or worsen reduced EF heart failure is a concern of caution.  Such use merits continual monitoring for net harm versus benefit on an individual basis.  The study in AJC documenting the high incidence of use of medications that worsen heart failure in patients already known to have reduced ejection fraction is helpful as a reminder of caution highlighting the importance of individualizing medication choices, but should not be rigidly interpreted as absolute contraindication or presumed error. 

SOURCE

From: Justin MDMEPhD <jdpmdphd@gmail.com>

Date: Tuesday, February 12, 2019 at 7:53 AM

To: Aviva Lev-Ari <aviva.lev-ari@comcast.net>

Subject: Re: Almost 25% of HFrEF patients prescribed drugs that could worsen their condition

UPDATED on 1/15/2019

Andrew Perry, MD, interviews John Gorcsan III, MD

by Andrew Perry, MDJanuary 12, 2019

In this episode, Andrew Perry, MD, discusses the utility of ejection fraction (EF) with John Gorcsan III, MD, an expert in echocardiography and strain imaging at Washington University School of Medicine in St. Louis.

They explore how EF came to be used in clinical practice, the importance of it in heart failure and the variation in measurement. The interview also covers strain imaging and what it adds to ejection fraction, particularly in the setting of severe mitral regurgitation.

A transcript of the podcast follows:

https://www.medpagetoday.com/cardiology/arrhythmias/77390?xid=nl_mpt_DHE_2019-01-15&eun=g99985d0r&pos=111111&utm_source=Sailthru&utm_medium=email&utm_campaign=Daily%20Headlines%202019-01-15&utm_term=NL_Daily_DHE_Active

UPDATED on 1/9/2019

HFrEF: NT-proBNP decrease marks reverse remodeling, better outcomes

Source: JACC Heart Fail

Curated by: Jenny Blair, MD

January 08, 2019

Takeaway

• In heart failure (HF) with reduced ejection fraction (HFrEF), a drop in pro-B-type natriuretic peptide (NT-proBNP) to <1000 mg/mL reflects reverse remodeling and improved ejection fraction (EF).
• Authors suggest that response to treatment based on change in NT-proBNP might outweigh treatment strategy.

Why this matters

• Whether lower NT-proBNP levels reflect changes in cardiac structure and function has been unclear.

Key results

• 12-month changes with guided therapy vs without:
  • No significant between-group differences in left ventricular (LV) end-systolic volume index (ESVi), NT-proBNP, EF.
• Changes among subgroup whose NT-proBNP fell to <1000 pg/mL (n=52):
  • ESVi and end-diastolic volume index (EDVi) reductions: 17.3 and 15.7 mL/m², respectively;
  • EF: 9.9%±8.8% vs 2.9%±7.9% in nontarget achievers (P<.001);
  • Death or HF hospitalization: 0% vs 30% in nontarget achievers (P<.001);
  • Greater improvement in global longitudinal strain, less mitral regurgitation.
• Greater reduction in NT-proBNP correlated with significantly greater EF, ESVi, EDVi improvements.

Study design

• Randomized parallel-group multicenter GUIDE-IT Echo Substudy.
• 268 adults with HFrEF, EF ≤40%, NT-proBNP >2000 pg/mL randomly assigned to NT-proBNP-guided therapy vs usual care.
• Outcome: 12-month change in LV ESVi on echocardiography.
• Funding: Roche Diagnostics.

Limitations

• Duration of NT-proBNP <1000 not assessed.

SOURCE

http://univadis.com/player/ymdmniqsi?m=unv_eml_essentials_enl_v4-q42018_20190109&partner=unl&rgid=5wrwznernxgefmacwqyebgmyb&ts=2019010900&o=tile_1_id&utm_source=Retention&utm_medium=newsletter&utm_campaign=unv_eml_essentials_enl_v4-q42018_20190109_01

Expert Opinion by Cardiologist Justin D. Pearlman MD PhD FACC

Pearls From: Ted Feldman, MD – A glimmer of hope for HFpEF treatment?

Evanston Hospital in Illinois

by Nicole Lou, Contributing Writer, MedPage TodayMay 08, 2018

SOURCE ARTICLE

https://www.medpagetoday.com/cardiology/chf/72759?xid=nl_mpt_DHE_2018-05-09

WATCH VIDEO

https://www.medpagetoday.com/cardiology/chf/72759?xid=nl_mpt_DHE_2018-05-09

Heart Failure with preserved Ejection Fraction (or HFpEF) – Experimental Therapy: Inter-atrial shunt implantable device for relieving pressure overload and improve the prognosis of patients with a 50% ejection fraction

vs

Heart Failure with reduced Ejection Fraction (HFrEF)

• HFpEF is similar in frequency and sadly, similar in prognosis to heart failure with reduced ejection fraction, and everybody thinks about the EF 20% or 30% patient as having a poor prognosis and doesn’t realize that the EF 40% or 45% or 50% patient with clinical heart failure has the same prognosis.
• Patients with mitral stenosis and elevated left atrial pressure, which is the genesis of HFpEF, if they had an ASD historically, this decompressed the left atrium and they presented much, much later in the course of the disease with any signs of heart failure.
• Inspiration for design of the Left inter-atrial shunt implant device

Minimally invasive transcatheter closure is the primary treatment option for secundum atrial septal defects (ASD). The AMPLATZER™ Septal Occluder is the proven standard of care in transcatheter ASD closure

• Left inter-atrial shunt implant device, Dr. Ted Feldman calls IASD.

It’s like an ASD occluder, a little nitinol disc, but it has a hole in the middle. We did some baseline hemodynamic modeling using a simulator and calculated that we would get a small shunt with an eight millimeter opening, that that would be enough to reduce left atrial pressure overload during exercise without overloading the right side of the heart, without creating too big a shunt.

Preliminary results: We found that peak exercise wedge pressure was significantly decreased in the patients with the device compared to those without a shunt. We found that the shunt ratio, the amount of flow across the shunt was a Qp:Qs, pulmonary to systemic flow ratio, of 1.2 preserved at 30 days and 6 months and that most of these patients feel better.

Ted Feldman, MD, Evanston Hospital in Illinois

The mechanism, I think we’ve established, that we do decompress the left atrium with exertion and now we need to demonstrate that the clinical outcomes in a larger population are robust enough to carry this into practice.

Expert Opinion by Cardiologist Justin D. Pearlman MD PhD FACC

• The assertion of “no treatment for HFpEF” (elevated left ventricular diastolic filling pressure) does not give credit to evidence and support for benefit from triple therapy of beta blocker, acei/arb/arni, and aldosterone inhibitor, plus tight blood pressure control and additional afterload reduction if valve leaks contribute to the elevated diastolic filling pressures.
• It is an interesting proposition to induce an 8 mm intra-atrial septum (IAS) shunt, which may indeed unload high pressure in the left atrium and hence unload the left ventricle during diastole (when the mitral valve is open so the left ventricle and left atrium equalize pressures) if patients are very carefully selected and do not have high pressures in the right atrium. 
• However, elevated left ventricular pressure is associated with reduced compliance (stiffness) of the left ventricle, for example due to high blood pressure, muscle hypertrophy and fibrosis. Adverse consequences include not only the high pressure which can back up to the lungs, making them boggy and therefore impair oxygen uptake resulting in shortness of breath worse laying down whereby more lung area is affected. The “back pressure” also promotes hepatic congestion and leg swelling. Each of those features of “diastolic failure” which underlies “HFpEF” may benefit from the proposed shunt if right atrial pressures are low, with or without preserved ejection fraction (pEF). However, there is an additional adverse consequence of a stiff left ventricle called “filling dependence” – if pressure is relieved, the left ventricle may under fill, reducing stroke volume and blood pressure, cardiac output (stroke volume times heart rate), thereby reducing organ perfusion. Low blood pressure with lightheaded spells is a common consequence. Over time, metarterioles to the brain can adjust to accommodate lower pressures. The kidneys as well as the brain are very sensitive to adequacy of cardiac output. A marked decline in renal function due to “pre-renal azotemia” is a common consequence that can limit any approach at lowering the diastolic filling pressure, which is seen commonly with use of diuretics to lower pressures.
• The small opening is intended to allow pressure unloading without clots crossing over, but may still pose a risk for paradoxical emboli, which have been associated with

1. visual field cuts,
2. TIA and
3. migraine headaches

Paradoxical Embolism

Updated: Jun 10, 2016

• Author: Igor A Laskowski, MD; Chief Editor: Vincent Lopez Rowe, MD  more…

 Background

The clinical manifestations of paradoxical embolism (PDE) are nonspecific, ^[1] and the diagnosis is difficult to establish. Patients with PDE may present with neurologic abnormalities or features suggesting arterial embolism. The disease starts with the formation of emboli within the venous system, which traverse a patent foramen ovale (PFO) and enter the systemic circulation. ^[2, 3, 4] PFOs have been found on autopsy in up to 35% of the healthy population.

PDE originates in the veins of the lower extremities and occasionally in the pelvic veins. Emboli may be of various types, such as clots, air, tumor, fat, and amniotic fluid. ^[5] Septic emboli have led to brain abscesses. Projectile embolization is rare (eg, from a shotgun pellet).

Management of PDE is both medical and surgical in nature. PDE is considered the major cause of cerebral ischemic events in young patients. On rare occasions, it may occlude the pelvic aortic bifurcation. The largest documented thrombus in a PFO (impending PDE) was 25 cm in length.

PDE is confirmed by the presence of thrombus within an intracardiac defect on contrast echocardiography or at autopsy. It may be presumed in the presence of arterial embolism with no evidence of left-side circulation thrombus, deep venous thrombosis (DVT) with or without pulmonary embolism (PE), and right-to-left shunting through an intracardiac communication, commonly the PFO. ^[6]

SOURCE for Paradoxical Embolism

https://emedicine.medscape.com/article/460607-overview

SOURCE for Dr. Pearlman’s Expert Opinion

From: Justin MDMEPhD <jdpmdphd@gmail.com>

Date: Wednesday, May 9, 2018 at 2:25 PM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Cc: “Dr. Larry Bernstein” <larry.bernstein@gmail.com>

Subject: Re: WHICH of our Heart Failure ARTICLES I should UPDATE with the following Pearls From: Ted Feldman, MD | Medpage Today

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