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Steps to minimise replacement of cardiac implantable electronic devices

Posted in Atrial Fibrilation (a-Fib), Cardiac Pacing and Arrhythmias, Cardiac and Cardiovascular Surgical Procedures, CE Mark & Global Regulatory Affairs: process management and strategic planning - GCP, Electrophysiology, FDA, CE Mark & Global Regulatory Affairs: process management and strategic planning - GCP, GLP, ISO 14155, Frontiers in Cardiology and Cardiovascular Disorders, Mechanical Assist Devices: LVAD, RVAD, BiVAD, Artificial Heart, Medical Devices R&D and Inventions on February 4, 2016| Leave a Comment »

UPDATED on 2/25/2019

https://www.medpagetoday.com/cardiology/prevention/78202?xid=nl_mpt_SRCardiology_2019-02-25&eun=g99985d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=CardioUpdate_022519&utm_term=NL_Spec_Cardiology_Update_Active

Medtronic recalled its dual chamber pacemakers (Adapta, Versa, Sensia, Relia, Attesta, Sphera, and Vitatron A, E, G, and Q series) due to a possible software error that can stop pacing.

Steps to minimise replacement of cardiac implantable electronic devices

Reporter: Aviva Lev-Ari, PhD, RN

Pacemaker battery scandal

SOURCE

http://www.bmj.com/content/352/bmj.i228

BMJ 2016; 352 doi: http://dx.doi.org/10.1136/bmj.i228 (Published 04 February 2016)Cite this as: BMJ 2016;352:i228
  1. John Dean, consultant cardiologist 1,
  2. Neil Sulke, consultant cardiologist 2

Author affiliations

  1. Correspondence to: J Dean john.dean2@nhs.net

Much can and should be done to maximise the longevity of existing devices

Imagine spending £3000 on a new watch with a battery embedded in the mechanism that cannot be replaced or recharged. Although the battery is predicted to last 10 years or more, after six years you discover that it is running flat and you’re advised to replace the watch immediately, even though it may keep good time for a year or more.

This mirrors the dilemma faced by all patients with cardiac implantable electronic devices such as pacemakers and implantable cardioverter defibrillators (ICD). But for them the stakes are much higher as replacing the battery exposes them to a risk of serious complications, including life threatening infection.

Over half of all patients with pacemakers require a replacement procedure because the batteries have reached their expected life.1 Some 11-16% need multiple replacements.2 The situation is worse for recipients of an ICD, since the risks of infection at the time of implant and device replacement are higher than with pacemakers and the batteries have a shorter life.3

What is the risk of infection?

With no standard definition or reporting system, infection rates vary widely, and the commonly quoted risk of 0.5% for new implants and 1-5% for replacement procedures may be wrong.4 Infection, even if it seems superficial, usually necessitates extraction of the entire system. Simply treating the infection with antibiotics results in a much poorer outcome.5 The increased risk of infection associated with battery replacement makes it critical that we prolong the life of implantable devices as much as possible. The health economic grounds for minimising the number of replacements are also compelling.6

The current financial model discourages the development of longer life devices. Increasing longevity would reduce profits for manufacturers, implanting physicians, and their institutions. With financial disincentives for both manufacturers and purchasers it is hardly surprising that longer life devices do not exist.

Patients are often assumed to prefer smaller devices, but when offered the choice, over 90% would opt for a larger, longer lasting device over a smaller one that would require more frequent operations to change the battery.7 And given the risks that patients are exposed to during replacement, there is an urgent need to improve longevity by developing longer life batteries and using those in current devices more prudently.

What can be done now?

At present the main drive to improving longevity of pacemakers has been through programming changes aimed at reducing the amount of pacing8 or minimising the drain of current during pacing—for example, using high impedance leads. But devices are usually replaced when there is still substantial life left in the battery. For example, when a pacemaker reaches elective replacement indication, it is usually 3-12 months before it will reach its end of life. And even then, the battery may continue to function for several months. Early replacement may be reasonable for high risk patients (such as those who are entirely dependent on their pacemaker). However, we could delay replacement of the pulse generator until the batteries are virtually depleted in lower risk patients. The increasingly popular innovation of home monitoring of devices would facilitate this.

For ICDs the waste is even more striking; devices reach their elective replacement indication when they are still capable of delivering at least six full energy shocks. Each shock reduces the battery longevity by about 30 days. So for patients who receive no shock therapy we are prematurely discarding a device costing up to £25 000 (€33 000; $36 000), which could last at least another six months (current devices last four to seven years on average). We need to review the timing of replacement of implantable devices in all patients.

CONTINUE READING

http://www.bmj.com/content/352/bmj.i228

REFERENCES

  1. ↵
    Kinderman M, Schwaab B, Berg M, Frohlig G. Longevity of dual chamber pacemakers: device and patient related determinants. Pacing Clin Electrophysiol2001;24:810-5.
    CrossRefMedline
  2. ↵
    Kurtz SM, Ochoa JA, Lau E, et al. Implantation trends and patient profiles for pacemakers and implantable cardioverter defibrillators in the United States: 1993-2006. Pacing Clin Electrophysiol2010;33:705-11.
    CrossRefMedline
  3. ↵
    Ramachandra I. Impact of ICD battery longevity on need for device replacements–insights from a Veterans Affairs database. Pacing Clin Electrophysiol2010;33:314-9.
    CrossRefMedline
  4. ↵
    Uslan DZ, Gleva MJ, Warren DK, et al, Cardiovascular implantable electronic device replacement infections and prevention: results from the REPLACE registry. Circulation2010;122:1553-61.
    Abstract/FREE Full Text
  5. ↵
    Gould PA, Krahn AD. Complications associated with implantable cardioverter-defibrillator replacement in response to device advisories. JAMA2006;295:1907-11.
    CrossRefMedlineWeb of Science
  6. ↵
    Boriani G, Braunschweig F, Deharo JC, Leyva F, Lubinski A, Lazzaro C. Impact of extending device longevity on the long-term costs of implantable cardioverter defibrillator therapy: a modelling study with a 15-year time horizon.Europace2013;15:1453-62.
    Abstract/FREE Full Text
  7. ↵
    Wild DM, Fisher JD, Kim SG, Ferrick KJ, Gross JN, Palma EC. Pacemakers and implantable cardioverter defibrillators: device longevity is more important than smaller size: the patient’s viewpoint. Pacing Clin Electrophysiol2004;27:1526-9.
    CrossRefMedline
  8. ↵
    Benkemoun H, Sacrez J, Lagrange P, et al. Optimizing pacemaker longevity with pacing mode and settings programming: results from a pacemaker multicenter registry. Pacing Clin Electrophysiol2012;35:403-8.
    CrossRefMedline

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A Magnetically controlled Mechanical Propeller for Immotile Sperm

Posted in Bio Instrumentation in Experimental Life Sciences Research, Bioengineering & reverse engineering design, Biomarkers & Medical Diagnostics, Biomedical Measurement Science, Cell Biology, Innovations, Medical Devices R&D and Inventions, Population Health Management, Reproductive Biology & Bio Instrumentation, tagged , , , , , , , , , , , on January 30, 2016| Leave a Comment »

A Magnetically controlled Mechanical Propeller for Immotile Sperm

Reporter and Curator: Dr. Sudipta Saha, Ph.D.

Researchers from the Institute for Integrative Nanosciences, IFW Dresden, Germany and Material Systems for Nanoelectronics, Chemnitz University of Technology, Germany have developed something known as the spermbot, a remotely controlled sperm movement controlling robot that could help create babies of the future. It is a magnetically powered robotic “suit” that can strap itself to individual sperm and help guide it faster towards the egg. According to the inventors all the initial tests with the spermbot have delivered promising results.

The purpose of the spermbot is to solve one of the widely talked about causes of infertility in men which is poor motility of sperm. Low sperm motility, or otherwise healthy sperm that just can’t swim, can be a big factor in infertility. While the development of the spermbot is in its early stages, this is already being talked about as a promising alternative to existing popular techniques that are expensive and come with a high failure rate. These include methods like in-vitro fertilization and artificial insemination. Only 30 percent of the traditional “spray-and-pray” approach ends up with success, which warranted the need for an alternative procedure like the spermbot. According to the report, initial experiments show a marked increase in the probability of the spermbot-assisted sperm to reach its intended destination. The process of fertilization can be completed inside the body or in the lab, inside a petri-dish.

The spermbot is a coat of microscopic metal polymers shaped into a helix. It can attach itself to the tail of the spermatozoid, and then, using a hybrid micromotor, it can help propel the sperm faster towards the egg. The direction the sperm needs to take is controlled using a rotating magnetic field. In fact, even the motion of the sperm can be remote-controlled by simply adjusting this magnetic field. Once the spermbot propels the sperm towards the egg and the sperm manages to implant itself into the egg, the bionic part of the spermbot detaches itself from the tail.

While the initial experiments look promising, there is still some way to go before the spermbot technique is regularly used. To start off, scientists have very few sample size to correctly evaluate the results, and unless more comprehensive tests are carried out, it would not be possible to start using them on human subjects. Another major stumbling block is that there is currently no way to film the spermbot in action while it is moving inside the body. This also means that doctors would not be able to correctly direct it towards the egg. Another concern is the response of the body’s own immune system to the spermbot. The use of the spermbot could trigger a reaction from the body’s immune system, the results of which cannot be predicted without comprehensive clinical trials. The idea of the spermbot looks promising right now, but it is still too early to call it a replacement to the tried and tested methods like in-vitro fertilization and artificial insemination. In fact, it would take a few years for the procedure to be made available to patients if clinical trials are successfully completed.

References:

http://pubs.acs.org/doi/abs/10.1021/acs.nanolett.5b04221

http://www.acs.org/content/acs/en/pressroom/presspacs/2016/acs-presspac-january-13-2016/spermbots-could-help-women-trying-to-conceive-video.html

http://www.inquisitr.com/2711435/spermbot-robot-sperm-infertility-treatment/#utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+google%2FyDYq+%28The+Inquisitr+-+News%29

http://www.slate.com/articles/video/video/2016/01/spermbot_attached_to_sperm_and_delivers_it_quickly_to_an_egg_video.html

http://www.sciencemag.org/news/2016/01/video-motorized-spermbot-helps-sperm-reach-egg

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Top 10 Medical Innovations for 2016 by Cleveland Clinic

Posted in CANCER BIOLOGY & Innovations in Cancer Therapy, CRISPR/Cas9 & Gene Editing, Frontiers in Cardiology and Cardiovascular Disorders, Genetics & Pharmaceutical, Genome Biology, Immuno-Oncology & Genomics, Infectious Disease & New Antibiotic Targets, Innovation in Immunology Diagnostics, PCI, Population Health Management, Genetics & Pharmaceutical, Preimplantation Genetic Diagnosis and Reproductive Genomics, Stents & Tools on October 28, 2015| Leave a Comment »

Top 10 Medical Innovations for 2016 by Cleveland Clinic

Reporter: Aviva Lev-Ari, PhD, RN

2.2.21

2.2.21   Top 10 Medical Innovations for 2016 by Cleveland Clinic, Volume 2 (Volume Two: Latest in Genomics Methodologies for Therapeutics: Gene Editing, NGS and BioInformatics, Simulations and the Genome Ontology), Part 2: CRISPR for Gene Editing and DNA Repair

What are the up-and-coming technologies and which will have the biggest impact on healthcare in 2016?

Cleveland Clinic’s culture of innovation naturally fosters a good deal of discussion about new “game changing” technologies and which ones will have the greatest impact each year. The passion of our clinicians and researchers for getting the best care for patients drives a continuous dialogue on what state-of-the art medical technologies are just over the horizon.

This content was developed to share outside Cleveland Clinic what our clinical leaders are saying to each other and what innovations they feel will help shape healthcare over the next 12 months.

#10 Neurovascular Stent Retrievers
The immediate hours after suffering an ischemic stroke are critical. The clot that occurs within a blood vessel must be removed within 3-6 hours in order to prevent long term disability, brain damage or death. For years, the only FDA-approved treatment for removing clots has been a tissue plasminogen activator, or tPA. The medicine, delivered intravenously, travels to the clot and dissolves and restores blood flow to the brain. When an occlusion forms in a major vessel, however, tPA has been effective in less than a third of all patients. Scientists for years have been looking for reinforcements that could aid tPA in eliminating main-stem clots as quickly and as safely as possible. The result is the Stent Retriever.

VIEW VIDEO

http://www.mdtmag.com/news/2015/10/top-10-medical-innovations-2016?et_cid=4908636&et_rid=461755519&type=image

#9 Frictionless Remote Monitoring
The wearable technology market has been skyrocketing in recent years. A recent study has estimated that 20% of American adults are wearing a device that collects data on anything from exercise and sleep habits to heart rate and blood pressure. The wide adoption has led to excitement about a potentially healthier population in the coming years. In addition to wellness, there are millions of sick patients that can benefit directly from wearables that are monitoring data at every breath, bead of sweat, or chemical change in the body. In many cases the reaction to these alterations can mean life or death.

VIEW VIDEO

http://www.mdtmag.com/news/2015/10/top-10-medical-innovations-2016?et_cid=4908636&et_rid=461755519&type=image

#8 First Treatment for HSDD
Sexual desire is different from sexual performance. There are several medications that address male sexual dysfunction. But none that address loss of sexual desire in women. Until now. In 2015, the FDA approved flibanserin, the first medication designed to treat female hypoactive sexual desire disorder (HSDD), or loss of sexual desire in premenopausal women.

VIEW VIDEO

http://www.mdtmag.com/news/2015/10/top-10-medical-innovations-2016?et_cid=4908636&et_rid=461755519&type=image

#7 Naturally Controlled Artificial Limbs
There have been numerous innovations in prosthetics over the years that have been able to mimic the natural movement, and provide a large boost to the quality of life of amputees and paralyzed individuals. But with over 6 million people paralyzed and 100,000 Americans living with an upper arm amputation, there is a large patient population that is paying close attention to an innovation that will yet again revolutionize the use of prosthetics.

VIEW VIDEO

http://www.mdtmag.com/news/2015/10/top-10-medical-innovations-2016?et_cid=4908636&et_rid=461755519&type=image

#6 Cancer Screening via Protein Biomarker Analysis
To understand the risk of cancer, scientists for years have focused narrowly on changes in the concentration of a single protein in biological fluids such as blood or urine or, alternatively, on genetic mutations. However, relatively poor sensitivity, specificity and predictive value generally limit the diagnostic accuracy and clinical utility of these tests.

VIEW VIDEO

http://www.mdtmag.com/news/2015/10/top-10-medical-innovations-2016?et_cid=4908636&et_rid=461755519&type=image

#5 Cell-free Fetal DNA Testing
The market in pregnancy wellness has grown to almost $2 billion as new parents increasingly invest in books, diets, and yoga classes all dedicated to ensuring their baby will be as healthy as possible when arriving. The potential for genetic diseases, like Down’s Syndrome, Edwards Syndrome, and Patau Syndrome however, are out of the control of the mother, and can therefore cause a great deal of stress, especially due to the vague and uncertain results of present tests.

VIEW VIDEO

http://www.mdtmag.com/news/2015/10/top-10-medical-innovations-2016?et_cid=4908636&et_rid=461755519&type=image

#4 Water Purification Systems for Prevention of Infectious Diseases
In the developing world, it is not uncommon to see sewage pile up in the streets with nowhere to go but into the local drinking water. This is an issue that contributes to more than 10% of the disease burden on the entire world. It is estimated that more than 700 million people in the world are drinking unsafe water every day, and according to the World Health Organization, more than a million children under the age of five in developing nations die each year as a result of contaminated water and poor sanitation.

VIEW VIDEO

http://www.mdtmag.com/news/2015/10/top-10-medical-innovations-2016?et_cid=4908636&et_rid=461755519&type=image

#3 Gene Editing using CRISPR
Not long ago, the ability to alter DNA of any organisms, including human embryos, was an idea thought up by science fiction authors and movie directors. A new technique, called CRISPR, however is proving not only that it’s possible, but that it can be done very easily and at very little cost when compared to prior gene editing attempts. And as a result — it is being adopted in labs everywhere.

VIEW VIDEO

http://www.mdtmag.com/news/2015/10/top-10-medical-innovations-2016?et_cid=4908636&et_rid=461755519&type=image

#2 Genomics-based Clinical Trials
Genomics-based clinical trials are speeding the development of new targeted therapies. They sort potential research participants by genetic criteria, and match them with the experimental therapy that targets the particular molecule associated with their disease. Genetic profiling shortens the time it takes to enroll patients and increases the chance that patients will benefit from the therapy being studied.

VIEW VIDEO

http://www.mdtmag.com/news/2015/10/top-10-medical-innovations-2016?et_cid=4908636&et_rid=461755519&type=image

#1 Vaccines to Prevent Public Health Epidemics
The number one spot in the 2015 Top Ten Medical Innovation goes to the scientists, physicians and public health officials who are developing safe, efficient and effective vaccines faster than ever to prevent disease epidemics. These efforts were given new urgency by the 2014 Ebola epidemic in Africa and of bacterial meningococcal (Meningococcal B) outbreaks in the United States. In both cases, physicians, scientists, companies and government agencies innovated with unprecedented speed to move new vaccines from laboratories to clinical testing in large populations.

VIEW VIDEO

http://www.mdtmag.com/news/2015/10/top-10-medical-innovations-2016?et_cid=4908636&et_rid=461755519&type=image

SOURCE

http://www.mdtmag.com/news/2015/10/top-10-medical-innovations-2016?et_cid=4908636&et_rid=461755519&type=image

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Abbott’s Bioabsorbable Stent met its Primary Endpoint in a U.S. Clinical Trial, applications for FDA Approval follows

Posted in Cardiac and Cardiovascular Surgical Procedures, Frontiers in Cardiology and Cardiovascular Disorders, PCI, Stents & Tools on October 13, 2015| Leave a Comment »

Abbott’s Bioabsorbable Stent met its Primary Endpoint in a U.S. Clinical Trial, applications for FDA Approval follows

Reporter: Aviva Lev-Ari, PhD, RN

 

Absorb device is designed to fully dissolve after delivering its anti-restenosis drug payload, unlike conventional drug-eluting stents what leave behind a metal scaffold.

 

Update  on 10/9/2020
Bioresorbable Stent Clinical Trials with New Esprit Below-the-knee Scaffold
Reporter: Irina Robu

 

TCT 2015: Abbott’s Absorb meets endpoint in U.S. pivotal trial

OCTOBER 12, 2015 BY

TCT 2015The Absorb bioabsorbable stent made by Abbott(NYSE:ABT) met its primary endpoint in a U.S. clinical trial that will be used to back a bid for FDA approval, researchers said today at the annual Transcatheter Cardiovascular Therapeutics conference in San Francisco.

One-year data from the Absorb III trial of 2,008 patients showed that the Absorb device was non-inferior to Abbott’s flagship Xience drug-eluting stent. The Absorb device is designed to fully dissolve after delivering its anti-restenosis drug payload, unlike conventional drug-eluting stents what leave behind a metal scaffold.

The trial showed a rate of target lesion failure of 7.8% for the Absorb arm and 6.1% for the Xience arm and no significant difference in rates of cardiac death (0.6% for the Absorb stent and 0.1% for the Xience stent); target vessel myocardial infarction (6.0% and 4.6%, respectively); or ischemia-driven target-lesion revascularization (3.0% and 2.5%, respectively. Device thrombosis occurred in 1.5% of Absorb patients and 0.7% of Xience patients, according to the study, which was also published in the New England Journal of Medicine.

“The Absorb III data shows that there are no statistically significant 1-year differences between Absorb and Xience, which is a major accomplishment given Xience’s strong performance as the current standard of care,” co-principal investigator Dr. Dean Kereiakes of Cincinnati’s Christ Hospital Heart & Vascular Center said in prepared remarks. “Naturally dissolving heart stents are the next revolution in percutaneous coronary intervention, and Absorb is leading the way as an innovative option. Absorb does its job and then restores the vessel to its natural state over time, which cannot be achieved with a permanent drug eluting stent.”

During a press conference discussing the results, Kereiakes cited Absorb’s performance in the context of a 1st-generation device going up against what he called the “gold standard” in Xience.

“The remarkable thing is that a gen-1 device really goes toe to toe [with Xience],” he said. “Longer-term evaluation is ongoing to determine if Absorb improves late outcomes compared with Xience.”

Asked about the value proposition for Absorb versus Xience, Dr. Daniel Simon of Cleveland’s Harrington Heart & Vascular Institute said providers are usually willing to pay a little more for new technologies.

“In medicine, in general, when you have technological iterations and innovations, one tends to pay more,” Simon said, noting that . “Health systems allow for companies to make fair profit, [in order] to have advances in medicine. … The long and the short of it is, we’ll pay a little more for a device that patients are asking for.”

Data from 2 other studies presented today at TCT 2015, Absorb II and Absorb China, also showed that the Absorb device functions similarly to Xience.

“The trial met all its major endpoints, and given all the attributes my opinion is that it should be approvable,” said Dr. Gregg Stone of New York’s Columbia University Medical Center, global chairman of the study. “We’ve got good reason to be very hopeful that the long-term outcomes for patients will be improved with this device compared with a normal metallic drug-eluting stent.

“A lot of patients would much rather have a dissolving stent that returns arteries back to their normal condition,” Stone said. “It will be very good for young patients who will live 30 or 40 years with this decision.”

“Results of the Absorb III pivotal trial show that Absorb is comparable to the best-in-class metallic stent. However, because Absorb leaves nothing behind it may provide significant longterm benefits, such as a restored vessel in a natural state and renewed possibilities for people treated with Absorb,” added Abbott vice president Dr. Charles Simonton in a press release. “At Abbott we will continue to study Absorb in our robust clinical trials to show the long-term benefits of Absorb that differentiate it from permanent, metallic stents.”

Material from Reuters was used in this report.

SOURCE

http://www.massdevice.com/tct-2015-abbotts-absorb-meets-endpoint-in-u-s-trial/?utm_source=newsletter-151013

 

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Protected: INVENTION: 3D Reparative Transforming BioStent – Concept Description

Posted in 3D Printing for Medical Application, Cardiac and Cardiovascular Surgical Procedures, CE Mark & Global Regulatory Affairs: process management and strategic planning - GCP, Frontiers in Cardiology and Cardiovascular Disorders, PCI, Stents & Tools on September 3, 2015|

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Protected: INVENTION: 3D Reparative Transforming BioStent – Concept Description

Posted in 3D Printing for Medical Application, Cardiac and Cardiovascular Surgical Procedures, CE Mark & Global Regulatory Affairs: process management and strategic planning - GCP, Frontiers in Cardiology and Cardiovascular Disorders, PCI, Stents & Tools on August 27, 2015|

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Ablation techniques in Interventional Oncology

Posted in Biomarkers & Medical Diagnostics, Cancer and Current Therapeutics, CANCER BIOLOGY & Innovations in Cancer Therapy, Cancer Surgery of the Heart, Clinical Diagnostics, Health Economics and Outcomes Research, Health Law & Patient Safety, Healthcare Reform, Human Immune System in Health and in Disease, Imaging-based Cancer Patient Management, Interventional Oncology: Radiofrequency Ablation, Transarterial Chemoembolization, Microwave Ablation and Irreversible Electroporation (IRE), Medical Devices R&D and Inventions, Medical Imaging Technology, Microwave Ablation and Irreversible Electroporation (IRE), Nuclear Medicine, Personalized and Precision Medicine & Genomic Research, Technology Capital Expenses, Transarterial Chemoembolization, tagged , , , , , , , , , , , , , , , , , , on August 5, 2015| Leave a Comment »

Ablation Techniques in Interventional Oncology

Author and Curator: Dror Nir, PhD

“Ablation is removal of material from the surface of an object by vaporization, chipping, or other erosive processes.”; WikipediA.

The use of ablative techniques in medicine is known for decades. By the late 90s, the ability to manipulate ablation sources and control their application to area of interest improved to a level that triggered their adaptation to cancer treatment. To date, ablation  is still a controversial treatment, yet steadily growing in it’s offerings to very specific cancer patients’ population.

The attractiveness in ablation as a form of cancer treatment is in the promise of minimal invasiveness, focused tissue destruction and better quality of life due to the ability to partially maintain viability of affected organs.  The main challenges preventing wider adaptation of ablative treatments are: the inability to noninvasively assess the level of cancerous tissue destruction during treatment; resulting in metastatic recurrence of the disease and the insufficient isolation of the treatment area from its surrounding.   This frequently results In addition, post-ablation salvage treatments are much more complicated. Since failed ablative treatment represents a lost opportunity to apply effective treatment to the primary tumor the current trend is to apply such treatments to low-grade cancers.

Nevertheless, the attractiveness of treating cancer in a focused way that preserves the long-term quality of life continuously feeds the development efforts and investments related to introduction of new and improved ablative treatments giving the hope that sometime in the future focused ablative treatment will reach its full potential.

The following paper reviews the main ablation techniques that are available for use today: Percutaneous image-guided ablation of bone and soft tissue tumours: a review of available techniques and protective measures.

Abstract

Background

Primary or metastatic osseous and soft tissue lesions can be treated by ablation techniques.

Methods

These techniques are classified into chemical ablation (including ethanol or acetic acid injection) and thermal ablation (including laser, radiofrequency, microwave, cryoablation, radiofrequency ionisation and MR-guided HIFU). Ablation can be performed either alone or in combination with surgical or other percutaneous techniques.

Results

In most cases, ablation provides curative treatment for benign lesions and malignant lesions up to 3 cm. Furthermore, it can be a palliative treatment providing pain reduction and local control of the disease, diminishing the tumor burden and mass effect on organs. Ablation may result in bone weakening; therefore, whenever stabilization is undermined, bone augmentation should follow ablation depending on the lesion size and location.

Conclusion

Thermal ablation of bone and soft tissues demonstrates high success and relatively low complication rates. However, the most common complication is the iatrogenic thermal damage of surrounding sensitive structures. Nervous structures are very sensitive to extremely high and low temperatures with resultant transient or permanent neurological damage. Thermal damage can cause normal bone osteonecrosis in the lesion’s periphery, surrounding muscular atrophy and scarring, and skin burns. Successful thermal ablation requires a sufficient ablation volume and thermal protection of the surrounding vulnerable structures.

Teaching points

• Percutaneous ablations constitute a safe and efficacious therapy for treatment of osteoid osteoma.

• Ablation techniques can treat painful malignant MSK lesions and provide local tumor control.

• Thermal ablation of bone and soft tissues demonstrates high success and low complication rates.

• Nerves, cartilage and skin are sensitive to extremely high and low temperatures.

• Successful thermal ablation occasionally requires thermal protection of the surrounding structures.

For the purpose of this chapter we picked up three techniques:

Radiofrequency ablation

Straight or expandable percutaneously placed electrodes deliver a high-frequency alternating current, which causes ionic agitation with resultant frictional heat (temperatures of 60–100 ˚C) that produces protein denaturation and coagulation necrosis [8]. Concerning active protective techniques, all kinds of gas dissection can be performed. Hydrodissection is performed with dextrose 5 % (acts as an insulator as opposed to normal saline, which acts as a conductor). All kinds of skin cooling, thermal and neural monitoring can be performed.

 

Microwave ablation

Straight percutaneously placed antennae deliver electromagnetic microwaves (915 or 2,450 MHz) with resultant frictional heat (temperatures of 60–100 ˚C) that produces protein denaturation and coagulation necrosis [8]. Concerning active protective techniques, all kinds of gas dissection can be performed, whilst hydrodissection is usually avoided (MWA is based on agitation of water molecules for energy transmission). All kinds of skin cooling, thermal and neural monitoring can be performed.

Percutaneous ablation of malignant metastatic lesions is performed under imaging guidance, extended local sterility measures and antibiotic prophylaxis. Whenever the ablation zone is expected to extend up to 1 cm close to critical structures (e.g. the nerve root, skin, etc.), all the necessary thermal protection techniques should be applied (Fig. 3).

13244_2014_332_Fig3_HTML

a Painful soft tissue mass infiltrating the left T10 posterior rib. b A microwave antenna is percutaneously inserted inside the mass. Due to the proximity to the skin a sterile glove filled with cold water is placed over the skin. c CT axial scan 3 months …

Irreversible Electroporation (IRE)

Each cell membrane point has a local transmembrane voltage that determines a dynamic phenomenon called electroporation (reversible or irreversible) [16]. Electroporation is manifested by specific transmembrane voltage thresholds related to a given pulse duration and shape. Thus, a threshold for an electronic field magnitude is defined and only cells with higher electric field magnitudes than this threshold are electroporated. IRE produces persistent nano-sized membrane pores compromising the viability of cells [16]. On the other hand, collagen and other supporting structures remain unaffected. The IRE generator produces direct current (25–45 A) electric pulses of high voltage (1,500–3,000 V).

Lastly we wish to highlight a method that is mostly used on patients diagnosed at intermediate or advanced clinical stages of Hepatocellular Carcinoma (HCC); transarterial chemoembolization  (TACE)

“Transcatheter arterial chemoembolization (also called transarterial chemoembolization or TACE) is a minimally invasive procedure performed in interventional radiology  to restrict a tumor’s blood supply. Small embolic particles coated with chemotherapeutic agents are injected selectively into an artery directly supplying a tumor. TACE derives its beneficial effect by two primary mechanisms. Most tumors within the liver are supplied by the proper hepatic artery, so arterial embolization preferentially interrupts the tumor’s blood supply and stalls growth until neovascularization. Secondly, focused administration of chemotherapy allows for delivery of a higher dose to the tissue while simultaneously reducing systemic exposure, which is typically the dose limiting factor. This effect is potentiated by the fact that the chemotherapeutic drug is not washed out from the tumor vascular bed by blood flow after embolization. Effectively, this results in a higher concentration of drug to be in contact with the tumor for a longer period of time. Park et al. conceptualized carcinogenesis of HCC as a multistep process involving parenchymal arterialization, sinusoidal capillarization, and development of unpaired arteries (a vital component of tumor angiogenesis). All these events lead to a gradual shift in tumor blood supply from portal to arterial circulation. This concept has been validated using dynamic imaging modalities by various investigators. Sigurdson et al. demonstrated that when an agent was infused via the hepatic artery, intratumoral concentrations were ten times greater compared to when agents were administered through the portal vein. Hence, arterial treatment targets the tumor while normal liver is relatively spared. Embolization induces ischemic necrosis of tumor causing a failure of the transmembrane pump, resulting in a greater absorption of agents by the tumor cells. Tissue concentration of agents within the tumor is greater than 40 times that of the surrounding normal liver.”; WikipediA

A recent open access research paper: Conventional transarterial chemoembolization versus drug-eluting bead transarterial chemoembolization for the treatment of hepatocellular carcinoma is discussing recent clinical approaches  related to this techniques.

Abstract

Background

To compare the overall survival of patients with hepatocellular carcinoma (HCC) who were treated with lipiodol-based conventional transarterial chemoembolization (cTACE) with that of patients treated with drug-eluting bead transarterial chemoembolization (DEB-TACE).

Methods

By an electronic search of our radiology information system, we identified 674 patients that received TACE between November 2002 and July 2013. A total of 520 patients received cTACE, and 154 received DEB-TACE. In total, 424 patients were excluded for the following reasons: tumor type other than HCC (n = 91), liver transplantation after TACE (n = 119), lack of histological grading (n = 58), incomplete laboratory values (n = 15), other reasons (e.g., previous systemic chemotherapy) (n = 114), or were lost to follow-up (n = 27). Therefore, 250 patients were finally included for comparative analysis (n = 174 cTACE; n = 76 DEB-TACE).

Results

There were no significant differences between the two groups regarding sex, overall status (Barcelona Clinic Liver Cancer classification), liver function (Child-Pugh), portal invasion, tumor load, or tumor grading (all p > 0.05). The mean number of treatment sessions was 4 ± 3.1 in the cTACE group versus 2.9 ± 1.8 in the DEB-TACE group (p = 0.01). Median survival was 409 days (95 % CI: 321–488 days) in the cTACE group, compared with 369 days (95 % CI: 310–589 days) in the DEB-TACE group (p = 0.76). In the subgroup of Child A patients, the survival was 602 days (484–792 days) for cTACE versus 627 days (364–788 days) for DEB-TACE (p = 0.39). In Child B/C patients, the survival was considerably lower: 223 days (165–315 days) for cTACE versus 226 days (114–335 days) for DEB-TACE (p = 0.53).

Conclusion

The present study showed no significant difference in overall survival between cTACE and DEB-TACE in patients with HCC. However, the significantly lower number of treatments needed in the DEB-TACE group makes it a more appealing treatment option than cTACE for appropriately selected patients with unresectable HCC.

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Stenting Provides Better Early Outcomes vs Angioplasty Alone for PAD – TCTMD

Posted in Cardiac and Cardiovascular Surgical Procedures, Frontiers in Cardiology and Cardiovascular Disorders, Medical Devices R&D and Inventions, PCI, Stents & Tools on June 8, 2015| Leave a Comment »

 

Stenting Provides Better Early Outcomes vs Angioplasty Alone for PAD – TCTMD

Reporter: Aviva Lev-Ari, PhD, RN

Stenting Provides Better Early Outcomes vs Angioplasty Alone for PAD TCTMD The reduction in amputation with stenting was observed across various high-risk subgroups, including elderly patients and those with acute or chronic limb ischemia, chronic…

Sourced through Scoop.it from: www.tctmd.com

See on Scoop.it – Cardiovascular and vascular imaging

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Protecting Your Biotech IP and Market Strategy: Notes from Life Sciences Collaborative 2015 Meeting

Posted in Academic Publishing, Affordable Care Act, Bio Instrumentation in Experimental Life Sciences Research, BioSimilars, BioTechnology - Venture Creation, Venture Capital, Commercialization, Conference Coverage with Social Media, Diagnostics and Lab Tests, Drug Delivery Platform Technology, Ecosystems & Industrial Concentration in the Medical Device Sector, FDA, FDA Regulatory Affairs, Global Partnering & Biotech Investment, Health Economics and Outcomes Research, Health Law & Patient Safety, Healthcare costs and reimbursement, HealthCare IT, Healthcare Reform, Intellectual Property, Intellectual Property, Innovations, Commercialization, Investment in technological breakthrough, Interviews with Scientific Leaders, Investment in Technological Breakthrough, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Medicare and Medicaid, Patents, Personal Health Applications: Tech Innovations serves HealhCare, Pharmaceutical Discovery, Pharmaceutical Industry Competitive Intelligence, Pharmaceutical R&D Investment, Population Health Management, Prescription Drugs Costs, Scientific & Biotech Conferences: Press Coverage, Scientist: Career considerations, Technology Capital Expenses, Uncategorized, Venture Capital, tagged , , , , , , , , , , , , , , , , , , , , , , , , , , , , , on March 11, 2015| Leave a Comment »

 

Protecting Your Biotech IP and Market Strategy: Notes from Life Sciences Collaborative 2015 Meeting

Reporter: Stephen J. Williams, PhD

Article ID #169: Protecting Your Biotech IP and Market Strategy: Notes from Life Sciences Collaborative 2015 Meeting. Published on 3/11/2015

WordCloud Image Produced by Adam Tubman

Achievement Beyond Regulatory Approval – Design for Commercial Success

philly2nightStephen J. Williams, Ph.D.: Reporter

The Mid-Atlantic group Life Sciences Collaborative, a select group of industry veterans and executives from the pharmaceutical, biotechnology, and medical device sectors whose mission is to increase the success of emerging life sciences businesses in the Mid-Atlantic region through networking, education, training and mentorship, met Tuesday March 3, 2015 at the University of the Sciences in Philadelphia (USP) to discuss post-approval regulatory issues and concerns such as designing strong patent protection, developing strategies for insurance reimbursement, and securing financing for any stage of a business.

The meeting was divided into three panel discussions and keynote speech:

  1. Panel 1: Design for Market Protection– Intellectual Property Strategy Planning
  2. Panel 2: Design for Market Success– Commercial Strategy Planning
  3. Panel 3: Design for Investment– Financing Each Stage
  4. Keynote Speaker: Robert Radie, President & CEO Egalet Corporation

Below are Notes from each PANEL Discussion:

For more information about the Life Sciences Collaborative SEE

Website: http://www.lifesciencescollaborative.org/

Or On Facebook

Or On Twitter @LSCollaborative

Panel 1: Design for Market Protection; Intellectual Property Strategy Planning

Take-home Message: Developing a very strong Intellectual Property (IP) portfolio and strategy for a startup is CRITICALLY IMPORTANT for its long-term success. Potential investors, partners, and acquirers will focus on the strength of a startup’s IP so important to take advantage of the legal services available. Do your DUE DIGILENCE.

Panelists:

John F. Ritter, J.D.., MBA; Director Office Tech. Licensing Princeton University

Cozette McAvoy; Senior Attorney Novartis Oncology Pharma Patents

Ryan O’Donnell; Partner Volpe & Koenig

Panel Moderator: Dipanjan “DJ” Nag, PhD, MBA, CLP, RTTP; President CEO IP Shaktl, LLC

Notes:

Dr. Nag:

  • Sometimes IP can be a double edged sword; e.g. Herbert Boyer with Paul Berg and Stanley Cohen credited with developing recombinant technology but they did not keep the IP strict and opened the door for a biotech revolution (see nice review from Chemical Heritage Foundation).
  • Naked patent licenses are most profitable when try to sell IP

John Ritter: Mr. Ritter gave Princeton University’s perspective on developing and promoting a university-based IP portfolio.

  • 30-40% of Princeton’s IP portfolio is related to life sciences
  • Universities will prefer to seek provisional patent status as a quicker process and allows for publication
  • Princeton will work closely with investigators to walk them through process – Very Important to have support system in place INCLUDING helping investigators and early startups establish a STRONG startup MANAGEMENT TEAM, and making important introductions to and DEVELOPING RELATIONSHIOPS with investors, angels
  • Good to cast a wide net when looking at early development partners like pharma
  • Good example of university which takes active role in developing startups is University of Pennsylvania’s Penn UPstart program.
  • Last 2 years many universities filing patents for startups as a micro-entity

Comment from attendee: Universities are not using enough of their endowments for purpose of startups. Princeton only using $500,00 for accelerator program.

Cozette McAvoy: Mrs. McAvoy talked about monetizing your IP from an industry perspective

  • Industry now is looking at “indirect monetization” of their and others IP portfolio. Indirect monetization refers to unlocking the “indirect value” of intellectual property; for example research tools, processes, which may or may not be related to a tangible product.
  • Good to make a contractual bundle of IP – “days of the $million check is gone”
  • Big companies like big pharma looks to PR (press relation) buzz surrounding new technology, products SO IMPORTANT FOR STARTUP TO FOCUS ON YOUR PR

Ryan O’Donnell: talked about how life science IP has changed especially due to America Invests Act

  • Need to develop a GLOBAL IP strategy so whether drug or device can market in multiple countries
  • Diagnostics and genes not patentable now – Major shift in patent strategy
  • Companies like Unified Patents can protect you against the patent trolls – if patent threatened by patent troll (patent assertion entity) will file a petition with the USPTO (US Patent Office) requesting institution of inter partes review (IPR); this may cost $40,000 BUT WELL WORTH the money – BE PROACTIVE about your patents and IP

Panel 2: Design for Market Success; Commercial Strategy Planning

Take-home Message: Commercial strategy development is defined market facing data, reimbursement strategies and commercial planning that inform labeling requirements, clinical study designs, healthcare economic outcomes and pricing targets. Clarity from payers is extremely important to develop any market strategy. Develop this strategy early and seek advice from payers.

Panelists:

David Blaszczak; Founder, Precipio Health Strategies

Terri Bernacchi, PharmD, MBA; Founder & President Cambria Health Advisory Professionals

Paul Firuta; President US Commercial Operations, NPS Pharma

 

Panel Moderator: Matt Cabrey; Executive Director, Select Greater Philadelphia

 

Notes:

David Blaszczak:

  • Commercial payers are bundling payment: most important to get clarity from these payers
  • Payers are using clinical trials to alter marketing (labeling) so IMPORTANT to BUILD LABEL in early clinical trial phases (phase I or II)
  • When in early phases of small company best now to team or partner with a Medicare or PBM (pharmacy benefit manager) and payers to help develop and spot tier1 and tier 2 companies in their area

Terri Bernacchi:

  • Building relationship with the payer is very important but firms like hers will also look to patients and advocacy groups to see how they respond to a given therapy and decrease the price risk by bundling
  • Value-based contracting with manufacturers can save patient and payer $$
  • As most PBMs formularies are 80% generics goal is how to make money off of generics
  • Patent extension would have greatest impact on price, value

Paul Firuta:

  • NPS Pharma developing a pharmacy benefit program for orphan diseases
  • How you pay depends on mix of Medicare, private payers now
  • Most important change which could affect price is change in compliance regulations

Panel 3: Design for Investment; Financing Each Stage

Take-home Message: VC is a personal relationship so spend time making those relationships. Do your preparation on your value and your market. Look to non-VC avenues: they are out there.

Panelists:

Ting Pau Oei; Managing Director, Easton Capital (NYC)

Manya Deehr; CEO & Founder, Pediva Therapeutics

Sanjoy Dutta, PhD; Assistant VP, Translational Devel. & Intl. Res., Juvenile Diabetes Research Foundation

 

Panel Moderator: Shahram Hejazi, PhD; Venture Partner, BioAdvance

  • In 2000 his experience finding 1st capital was what are your assets; now has changed to value

Notes:

Ting Pau Oei:

  • Your very 1st capital is all about VALUE– so plan where you add value
  • Venture Capital is a PERSONAL RELATIONSHIP
  • 1) you need the management team, 2) be able to communicate effectively                  (Powerpoint, elevator pitch, business plan) and #1 and #2 will get you important 2nd Venture Capital meeting; VC’s don’t decide anything in 1st meeting
  • VC’s don’t normally do a good job of premarket valuation or premarket due diligence but know post market valuation well
  • Best advice: show some phase 2 milestones and VC will knock on your door

Manya Deehr:

  • Investment is more niche oriented so find your niche investors
  • Define your product first and then match the investors
  • Biggest failure she has experienced: companies that go out too early looking for capital

Dr. Dutta: funding from a non-profit patient advocacy group perspective

  • Your First Capital: find alliances which can help you get out of “valley of death”
  • Develop a targeted product and patient treatment profile
  • Non-profit groups ask three questions:

1) what is the value to patients (non-profits want to partner)

2) what is your timeline (we can wait longer than VC; for example Cystic Fibrosis Foundation waited long time but got great returns for their patients with Kalydeco™)

3) when can we see return

  • Long-term market projections are the knowledge gaps that startups have (the landscape) and startups don’t have all the competitive intelligence
  • Have a plan B every step of the way

Other posts on this site related to Philadelphia Biotech, Startup Funding, Payer Issues, and Intellectual Property Issues include:

PCCI’s 7th Annual Roundtable “Crowdfunding for Life Sciences: A Bridge Over Troubled Waters?” May 12 2014 Embassy Suites Hotel, Chesterbrook PA 6:00-9:30 PM
The Vibrant Philly Biotech Scene: Focus on KannaLife Sciences and the Discipline and Potential of Pharmacognosy
The Vibrant Philly Biotech Scene: Focus on Computer-Aided Drug Design and Gfree Bio, LLC
The Vibrant Philly Biotech Scene: Focus on Vaccines and Philimmune, LLC
The Bioscience Crowdfunding Environment: The Bigger Better VC?
Foundations as a Funding Source
Venture Capital Funding in the Life Sciences: Phase4 Ventures – A Case Study
10 heart-focused apps & devices are crowdfunding for American Heart Association’s open innovation challenge
Funding, Deals & Partnerships
Medicare Panel Punts on Best Tx for Carotid Plaque
9:15AM–2:00PM, January 27, 2015 – Regulatory & Reimbursement Frameworks for Molecular Testing, LIVE @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA
FDA Commissioner, Dr. Margaret A. Hamburg on HealthCare for 310Million Americans and the Role of Personalized Medicine
Biosimilars: Intellectual Property Creation and Protection by Pioneer and by Biosimilar Manufacturers
Litigation on the Way: Broad Institute Gets Patent on Revolutionary Gene-Editing Method
The Patents for CRISPR, the DNA editing technology as the Biggest Biotech Discovery of the Century

 

 

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Fractional Flow Reserve vs. Angiography in Non-ST-segment Elevation Myocardial Infarction

Posted in Acute Myocardial Infarction, CABG, Cardiac & Vascular Repair Tools Subsegment, Cardiac and Cardiovascular Surgical Procedures, Frontiers in Cardiology and Cardiovascular Disorders, Myocardial metabolism, Myocardial ischemia, myocardial perfusion, Myocardial adenine nucleotide metabolism, Origins of Cardiovascular Disease, PCI, Stents & Tools on February 24, 2015| Leave a Comment »

Fractional Flow Reserve vs. Angiography in Non-ST-segment Elevation Myocardial Infarction

Reporter: Aviva Lev-Ari, PhD, RN

 

Jamie Layland, Keith G. Oldroyd, Nick Curzen, Arvind Sood, Kanarath Balachandran, Raj Das, Shahid Junejo, Nadeem Ahmed, Matthew M.Y. Lee, Aadil Shaukat, Anna O’Donnell, Julian Nam, Andrew Briggs, Robert Henderson, Alex McConnachie, Colin Berry

Disclosures

Eur Heart J. 2015;36(2):100-111. 

Aim

We assessed the management and outcomes of non-ST segment elevation myocardial infarction (NSTEMI) patients randomly assigned to fractional flow reserve (FFR)-guided management or angiography-guided standard care.

Methods and results

We conducted a prospective, multicentre, parallel group, 1 : 1 randomized, controlled trial in 350 NSTEMI patients with ≥1 coronary stenosis ≥30% of the lumen diameter assessed visually (threshold for FFR measurement) (NCT01764334).

Enrolment took place in six UK hospitals from October 2011 to May 2013. Fractional flow reserve was disclosed to the operator in the FFR-guided group (n 1/4 176). Fractional flowreserve was measured but not disclosed in the angiography guided group (n 1/4 174). Fractional flowreserve ≤0.80was an indication for revascularization by percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG). The median (IQR) time from the index episode of myocardial ischaemia to angiographywas 3 (2, 5) days. For the primary outcome, the proportion of patients treated initially by medical therapy was higher in the FFR-guided group than in the angiography-guided group [40 (22.7%) vs. 23 (13.2%), difference 95% (95% CI: 1.4%, 17.7%), P 1/4 0.022]. Fractional flow reserve disclosure resulted in a change in treatment between medical therapy, PCI or CABG in 38 (21.6%) patients. At 12 months, revascularization remained lower in the FFR-guided group [79.0 vs. 86.8%, difference 7.8% (20.2%, 15.8%), P 1/4 0.054]. There were no statistically significant differences in health outcomes and quality of life between the groups.

Conclusion

In NSTEMI patients, angiography-guided management was associated with higher rates of coronary revascularization compared with FFR-guided management. A larger trial is necessary to assess health outcomes and cost-effectiveness.

SOURCE

http://eurheartj.oxfordjournals.org/content/ehj/36/2/100.full.pdf 

 

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