Cardiac Health: Implantable Cardiac Devices – number of procedures on the rise, but is the technology really there to handle this boom?

It is reported that an estimated 650,000 people in the United States currently have implanted cardiac devices (ICD’s) designed for defibrillation (cardiac electro-shock therapy) or combination defibrillation and heart pacing.  For you  Baby Boomers rounding (or having passed) the 60’s bend, these numbers are expected to grow exponentially.  Cardiovascular Business posted an article on April 20 advising that hospital admissions for implantation of ICD’s increased ten-fold from 1990 to 2005.

This same article was quite alarming in its lack of scientific data on factors that determine the best results.  While it may be comforting to know that several large patient-studies have recently shown that centers performing the greatest numbers of procedures have the lowest rates of procedural complications, it is important to also note that authorities in this area of medicine warn that more data and study are needed on individual operator volume, specialty identification, training, performance and outcomes.

Cardiovascular Business News released a feature on April 20, 2010, citing an article published in 2009 by the Journal of the American Medical Association.  The data suggest that your odds of having procedural complications were greater if the device was implanted by a non-electrophysiologist. In short, does this mean you have better odds with an electrophysiology cardiologist? What about a general cardiologist? Or a thoracic surgeon? The study data apparently did not adjust for underlying health conditions or patients who are more ill. Why not? Are we to assume the latter groups of patients may have merely been more prone to complications? Or do the non-electrophysiologists just have less experience and training in implanting ICD devices? As of this time, Boomers, the medical profession has not published answers to these questions.

Perhaps we should be encouraged that Medicare is requiring implant and performance outcome data. As of June 2009, the agency had collected information on more then 380,000 implants.  Yet almost a year later, with many more procedures entered into that same database, the medical specialty communities are still unable to let us know which are the safest specialists and hospitals performing ICD implant procedures.  Physicians say longer term outcomes are needed.

In the meantime, are Medicare and other payors paying for all procedures regardless of the quality of practitioner or hospital performance?

More alarming, on May 17, 2010, Dr. Westby G. Fisher, a cardiologist at North Shore University Hospital Health System wrote in medcitynews.com that the medical system currently can no longer sustain the volume to maintain the implanted devices safely. He complains that physicians are unable to re-program ICD devices remotely.  Is this true? Due to the growing volume of implanted devices now occurring, technicians with no medical degree are programing patient devices from remote locations with sometimes no documentation or notification to the patient’s physician. Physicians are supposed to be overseeing the process according to Dr. Foster. However, he is of the opinion that due to the high maintenance these devices require, along with the growing number of patients, managing the technology will be of great concern to the boomer population and their physicians.  Once again, how are the pressing issues of quality, safety, and cost going to be timely addressed in this burgeoning aspect of our healthcare?

Finally, perhaps we can be comforted by the recent news release from the Heart Rhythm Society. Apparently, the medical profession had never previously determined parameters on how and when to stop these devices at the end of one’s life.  The study cited a dying patient whose defibrillator went-off  greater than 12 times, causing the patient needless suffering. Several groups of medical societies have now have published a consensus statement outlining ethical and legal issues, a decision-making algorithm for withdrawing/deactivating the device(s), and rights/responsibilities for those physicians who have ethical conflicts. The Heart Rhythm Society is encouraging and educating physicians and patients on what needs to happen in this algorithm for ending ICD-sustained life.

One can only hope that a physician is not placed into a remote call-waiting voicetree for dying boomers when the time comes to deactivate. It’s bad enough that we don’t yet know how to choose the best physician and/or hospital to have these devices implanted. Now there is growing concern that simple but critical issues of maintenance, remote re-programming and the like will get out-of-hand due to the ever increasing volume of these devices being implanted.

Contributor: Sharon M. Stabile

Cerebral Palsy: Cord Blood Stem Cell Research and Treatment in Clinical Trials – Update

For those of  you who follow our blogs, you know well that this is a topic of interest for us.  It bears repeating – our job as lawyers is to properly investigate potential claims of malpractice in areas such as cerebral palsy and seek redress for our clients when the evidence demonstrates a connection between birth injuries and medical care, but the much more important topic for our clients and victims of cerebral palsy is in the field of medical research. It is through research efforts – including clinical trials – that this dreaded condition will be ameliorated and hopefully eradicated. Trust me, after practicing law for over 35 years, I’m not worried about job security – the frailties of the human condition will more than suffice to fill our file cabinets with people to help due to the negligence of others.

We have reported previously on various topics involving cord blood and stem cell research as they relate to a number of conditions, including cerebral palsy.  It seems that months have passed since there has been any significant news about two programs underway: one at the Medical College of Georgia and the other at Duke.  Earlier this month, an update came across the social media network via a post by Singularity Hub – Cord Blood Stem Cell Treatment for Cerebral Palsy in Clinical Trial | Singularity Hub.

Here’s our encapsulated version regarding the studies and Singularity Hub’s report.

Photo provided by MSNBC

Duke University

According to the website ClincalTrials.gov, Duke began a clinical therapeutic trial – identifier: NCT00593242 – in January 2008 (estimated completion date of January 2011) whose primary purpose is listed as treatment of newborns with hypoxic ischemic encephalopathy (HIE) – inadequate oxygenation in the perinatal period for purposes of this study – through the controlled “collection, preparation and infusion of a baby’s own (autologous) umbilical cord blood in the first 14 days after birth if the baby is born with signs of brain injury.” For information concerning the inclusion and exclusion criteria for participation in this clinical trial, see the online posting. Essentially, the babies are then to be “followed for neurodevelopmental outcome at 4 – 6 and 9 – 12 months at Duke’s Special Infant Care Clinic. MRI’s will be obtained between postnatal weeks 1 and 4, and, for study purposes at 4 – 6 postnatal months.”

While other aspects of processing and administration are no doubt part of the key components of this project, it is readily apparent that the end-point goal is discovery of an effective treatment of cerebral palsy for the identified neonates in the study and then development of a second stage clinical trial to take such treatment modality to a greater number of potential beneficiaries.

Medical College of Georgia

For detailed information on this study, which began in February of this year, similar information is available through ClinicalTrials.gov under identifier NCT01072370.  This clinical trial investigation has a patient population consisting of children from ages of 2 to 12, “whose parents have saved their infant’s cord blood, who have non-progressive motor disability, and whose parents intend to have a cord blood infusion.”  Again – for full details regarding inclusion and exclusion criteria, see the full online posting.

For those parents who may be interested in determining if their child would qualify to participate, the study is still recruiting participants.  The contact information is also available at this link: Contact: James E Carroll, M.D.     706-721-3371     jcarroll@mcg.edu

Today’s report from Singularity Hub provides some encouraging – albeit anecdotal – news of potential progress.

The anecdotal evidence in support of treating cerebral palsy with cord blood stem cells is astounding. Much of it has actually been been performed at Duke University by one of the investigators in the pilot study: Joanne Kurtzberg. Among those that have been successfully treated at Duke include Ryan Schneider, Maia Friedlander, Chloe Levine, and Dallas Hextell. All had CP or CP-like symptoms and all made remarkable recoveries after cord blood stem cell treatments. Dallas Hextell, who showed improvements just 5 days after his therapy was featured on the Today show (the original report contains video compliments of MSNBC).

In addition to the early good news coming out of these projects, one other lesson is learned – for the time being, the storage of cord blood is an important component for those hoping to participate in such studies – particularly that being conducted at the Medical College of Georgia.  We have earlier reported on this topic as well.  You may want to refer to our early posting for some basic information if you are interested.

Obviously, the implications – if these projects prove to be successful – are far-reaching. The enthusiasm of the participants in these research projects is not limited to them alone. The words of the author, Aaron Saenz, from Singularity Hub somewhat tells it all:

So we have some exciting news for cerebral palsy, and some exciting news for those thinking about cord blood. What about the rest of us? Well the MCG and Duke work has some far reaching implications. Neurological damage, whether it’s caused by oxygen deprivation or some other injury, is one of the most difficult things to heal in the body. Work in animals (like that done by Carroll on rats) show that stem cells can not only help damaged brain cells recover, but they can also replace cells that have died. We may find that stem cells therapies have a wide range of applications for many different forms of brain damage. Kurtzberg is researching many different ways cord blood could be used (autologous or through donors) to treat a variety of conditions. In other words, today stem cells conquer cerebral palsy…tomorrow, the world.

Let’s all hope that Mr. Saenz is a prophet.

Computer May Be Better Than Your Doctor in Providing Information for Obtaining Your Informed Consent

When most people think about medical malpractice, they think about a doctor making a mistake during surgery, or failing to order a necessary test, or making the wrong diagnosis. In other words, a mistake in the actual rendering of medical care. However, a doctor can also be negligent in his or her communications with a patient even before the doctor undertakes the treatment at issue.

Under the law, a doctor is required to explain to the patient the risks, benefits and alternatives of treatment so that the patient can make an informed decision about whether to proceed with treatment. This is called “informed consent” and is a critical step in the process of getting competent medical care.  

While some doctors and hospitals have generic consent forms that you sign before surgery, the actual informed consent process is typically handled by the doctor, usually in the doctor’s office. At this time, the doctor is required to explain the treatment, what it entails, the risks involved (i.e., death, infection, etc.), and whether there are any less  invasive alternatives or other available options for care. If the doctor fails to thoroughly explain these issues, then he or she can be held liable if the patient did not understand the full ramifications of the procedure and suffered injury as a result.

One of the difficulties of informed consent is that it is usually done verbally, and we all know the difficulty of trying to remember all the details when someone is explaining something to us, whether it’s directions to a local store, or how to program a new cell phone. It can be especially difficult in the context of a doctor’s office when the patient is already under stress and is being bombarded with complicated medical terminology. It is not surprising that many patients have little or no recall of the actual risks of treatment that doctors routinely say they explain to their patients.

One method that is currently being explored to improve this process is the use of computer programs to help educate patients. In a new study, researchers at the University of Melbourne and Austin Hospital in Australia tested a computer program in forty patients scheduled to undergo surgery to remove the prostate gland.

The computer program included slides with animations detailing the procedure, its potential complications and the post-surgery recovery. Each slide contained questions for the patient to answer, and he could move on to the next slide only after he gave the correct responses.

Patients were randomly assigned to one of two groups. One group received standard informed consent verbally from their doctor. The second group got to use the computer. The study found that the patients in the computer group scored much higher on test questions about the procedure – 78% correct answers versus 57% in the standard group. Why the difference?

Having patients answer questions helps turn the process into an “education and knowledge tool,” according to Dr. Nathan Lawrentschuk, one of the researchers on the study, which appears in the urology journal BJU International.  It may also allow doctors and nurses to “hone in on areas not understood, rather than assuming our patients understand what we say,” Lawrentschuk told Reuters Health in an email.

We look forward to further advances in this technology so that patients can make informed decisions about their medical treatment. Let us know if you have ever given ‘informed consent’ after being advised of the risks and alternatives by a computer.  We would appreciate you sharing with us how, if at all, that process improved your understanding of the surgery you were about to undergo.

Hundreds of Donor Kidneys That Could Save Lives Tossed Away Each Year

An article published on April 1, 2010, by MedlinePlus reports that each year hundreds of  kidneys are thrown away because they are found to be infected with Hepatitis C.  According to the article, since 1995, more than 3,500 have been discarded.

The use of such kidneys has been reported as controversial “due to a 1 percent difference in one-year survival and a 2 percent difference in three-year survival among these patients.”      

Dr. Dorry L. Segev, an associate professor of surgery at Johns Hopkins, the lead researcher of a published study dealing with this problem, determined that more than 1,000 of these discarded kidneys were from “what would be considered perfect donors.”

“Using hepatitis C-positive kidneys in people who are infected with the virus could help those with hepatitis C and also expand the organ supply for everyone,” Segev said.

Among patients with kidney failure, about 12 percent are infected with hepatitis C. These patients are at increased risk of death on dialysis compared with those without the virus, the researchers said.

According to the study, “Segev’s group found that one-third of the transplant centers in the United States do not use any kidneys infected with hepatitis C for hepatitis C-infected patients. On the other hand, 13 percent of transplant centers transplanted more than 50 percent of their hepatitis C-infected patients with kidneys infected with the disease.”

Having represented clients, who are in dire need of kidney transplantation, this study will hopefully go a long way toward a new awareness in the transplantation community that disposing of these critical organs makes no sense.

We are told stories by our clients of their desperate wait for the call from the transplant center.  We hear from others how sometimes 3 to 5 times a week they might get a call that ‘tonight might be the night – stay ready” – but the night comes and goes without the call to come to the hospital for their new kidney.

Kudos to Dr. Segev and his research team.  Hopefully the transplantation community will heed his advice and more patients will benefit by this rational approach to an ever-growing problem – a shortage of vital organs for transplantation.

MRI Beats X-Ray for Spotting Fractures in ER

A recent article in Medline Plus reports that the National Institute of Health (NIH) announced recently the results of a new study, which called into question the accuracy of x-rays in detecting hip and pelvic fractures.  In the study, researchers at the Duke University Medical Center analyzyed data on 92 patients who received both an x-ray and an MRI (magnetic resonance imaging) to evaluate hip and pelvic pain.  The results:

“Thirteen patients with normal X-ray findings were found to collectively have 23 fractures at MRI,” the study’s lead author, Dr. Charles Spritzer, said in a news release from the American College of Radiology/American Roentgen Ray Society.  In addition, the study found that, “in 11 patients, MRI showed no fracture after X-rays had suggested the presence of a fracture,” Spritzer said. “In another 15 patients who had abnormal X-ray findings, MRI depicted 12 additional pelvic fractures not identified on X-rays.”

While x-rays tend to be the front-line study in the emergency room setting (primarily because of cost), this new study suggests that MRI may be a better approach for suspected fractures, which will hopefully lead to more patients getting an accurate diagnosis and proper treatment.

Cerebral Palsy: new research to improve dexterity by home therapy using modified gaming instruments.

Today I came across yet another interesting and common sense concept in the quest to help those with cerebral palsy for performing important dexterity exercises in the comfort of their home.  The article – Daily Targum – Researchers spawn new therapy for cerebral palsy patients – recounts a small study (3 teenage patients) taking place over the last year at Rutgers University and Indiana University using a modified Sony PlayStation 3 gaming glove to improve dexterity for victims of cerebral palsy.  

One of the keys in this research project is to find a way to move therapy into the patient’s home utilizing an activity that all kids enjoy – gaming.  The basic goal is to not only move important therapy into the home but to provide a method for young cerebral palsy patients to perform this therapy without the need of costly and time-contrained supervision.

The program is the product of a collaborative effort of these universities headed by Grigore Burdea, a University professor of electrical and computer engineering, and Moustafa Abdelbaky, an electrical and computer engineering graduate student.  Another key player in this endeavor is Meredith Golomb, an associate professor of neurology at Indiana University School of Medicine.  She found out about Burdea’s work through the Internet and said the combination of her skills with Burdea’s was perfect.

“I’m a pediatric neurologist and know how to assess the kids medically,” Golomb said. “He is an engineer and knows how to get the systems working — it has been a great collaboration so far.”

Some weeks ago, I posted a story about research underway at the University of Michigan in the use of a treadmill to help improve the neuromotor development of younger children with cerebral palsy.

It is through the work of such researchers and many others devoted to helping discover the causes of cerebral palsy that key progress in making the lives of these people with special needs better will be made.  We will  keep you posted on similar studies and research efforts.  Hopefully, if you are the parent of a child with cerebral palsy, you will find one of these techniques of interest and potentially useful in maximizing the chances of a better life for your child.

Study Finds Stents as Effective as Surgery to Prevent Strokes; European Study Finds Otherwise

A few weeks ago, the NY Times published a story about a recent North American study designed to examine the efficacy of stenting versus surgery of the carotid artery for the prevention of strokes. Known as the Crest (Carotid Revascularization Endarterectomy versus Stenting Trial) Study, the project was designed to determine if the less invasive procedure known as stenting (i.e. placing a small tube inside the carotid artery) was an equally safe and effective treatment option to surgery for the prevention of stroke.  

Strokes are reported to be “the third leading cause of death in the United States and a major cause of disability among adults. Each year, almost 800,000 Americans suffer a stroke, and more than 140,000 die.”

Of concern, however, is a European study published online in the Lancet the day before the announcement of the Crest Study results.  According to Dr. Martin M. Brown, chief investigator for the European trial, the International Carotid Stenting Study, their investigation showed “dismal results” from stenting versus surgery in their study group population of 1,173 randomly selected patients (the Crest study involved 2,502 patients from more than 100 hospitals in North America).

Dr. Brown said that although differences in the groups studied might explain the disparate results, “nobody has really shown stenting is better than surgery, so why choose a stent?”

Dr. Brown added, “Even if Crest shows little difference between the two, there are three other trials that suggest surgery is safer.”

On the other side of the debate, however, are the statements of the lead author of the Crest Study, Dr. Thomas  Brott, who is quoted in the NY Times article as saying:

“We had outstanding results, and our study, we think, is representative of these treatments in the United States and Canada. Prior to the Crest trial, we really did not have the best evidence, but these results indicate that we have two very safe and effective methods to prevent stroke.” Though there are differences in risk between the two procedures and individual variations, he said, “the results from stenting are very comparable to those for carotid surgery.”

The differences in the two studies in terms of mortality and morbidity are summarized in the Times article.

What to make out of all this remains the question.  Hopefully further studies will provide a clearer answer.

I am not a doctor, and I suspect, you, the reader, are probably not either.  What I can say is this – and it is what I have been advocating throughout many of our blogs – be an educated patient.  Ask questions if you find yourself or a loved one presented with this option of surgery versus stenting and ask the right questions of your doctor.  Why is one option being suggested by your doctor over the other?  What are the risks of each procedure?  While one procedure may be “less invasive” than the other, there are still risks associated with each.  “Less invasive” is not always the answer.   I further encourage you to ask your doctor what his or her experience is in performing carotid artery stenting.  Remember, the Crest Study had one key element – “carefully screened … doctors doing the stenting procedure, including only highly skilled physicians with a lot of experience.”  Make sure your doctor fits that description.

Strokes – Family History a Significant Risk Factor

According to an article published by WebMD, individuals whose parents have had a stroke by age 65 are more likely to have a stroke.

Strokes are generally defined as disturbances of blood flow in the brain as a result of a ruptured blood vessel, a blockage within the lumen of the blood vessel, or some other ischemic process. The ischemic process can cause brain tissue to die, resulting in death or permanent brain injury. In all respects, strokes represent medical emergencies.

Among other things, the following are generally considered to be risk factors for developing a stroke: previous history of strokes, brain trauma, advanced age, increased lipid levels, increased blood pressure, diabetes, atrial fibrillation, and smoking.

The results of the study suggest that a person’s family history of strokes should also be considered in assessing the risk for developing a stroke.

Researchers studied 3,443 people who initially were stroke free and second-generation participants in the Framingham Heart Study. The participants’ parents had reported 106 strokes by age 65, and offspring 128, over the 40-year study. People with a parent who had a stroke by age 65 had twice the risk of having a stroke at any age and four times the risk by 65, after adjusting for conventional risk factors.

Contributing author: Jon Stefanuca

Ovarian Cancer – The Smear Test Won’t Tell You Much

According to an article published by the UK Press Association, a UK study revealed that one in three women mistakenly believe that a smear test can diagnose ovarian cancer. The test is also known as Papanicolaou test, Pap smear, Pap test, or cervical smear.

[The smear test] is a screening test used in gynecology to detect premalignant and malignant (cancerous) processes in the ectocervix. … In taking a Pap smear, a tool is used to gather cells from the outer opening of the cervix (Latin for “neck”) of the uterus and the endocervix. The cells are examined under a microscope to look for abnormalities. The test aims to detect potentially pre-cancerous changes (called cervical intraepithelial neoplasia (CIN) or cervical dysplasia), which are usually caused by sexually transmitted human papillomaviruses (HPVs). The test remains an effective, widely used method for early detection of pre-cancer and cervical cancer. The test may also detect infections and abnormalities in the endocervix and endometrium.

While the smear test is customarily used to diagnose cervical cancer, it is not very helpful in diagnosing ovarian cancer. Cervical cancer and ovarian cancer are distinct medical conditions with distinct symptoms. Cervical cancer refers to malignant tissue developing in the cervix – the organ, which connects the uterus and the vagina. Last year, there were about 4,070 deaths associates with cervical cancer. The smear test is effective in diagnosing cervical cancer.

Ovarian cancer refers to malignant tissue in one or both of the ovaries. Last year, there were about 14,600 deaths associated with ovarian cancer – a much higher mortality rate when compared to that of cervical cancer. Symptoms of ovarian cancer include, but are not limited to : abdominal pressure, abdominal distention, urinary urgency, abdominal pain and discomfort, indigestion, constipation, changes in menstruation, lethargy, and pain during intercourse.

According to the article,

Almost one in three women (29%) mistakenly believe a smear test will pick up signs of ovarian cancer. …  Only 4% are confident they could spot symptoms of the disease themselves and many believe it is less common than cervical cancer. … The poll of more than 1,000 women found that twice as many (66%) had been given information about cervical cancer as those who had details on ovarian cancer (33%). Of women diagnosed with ovarian cancer, more than half (56%) did not know anything about the disease beforehand.

These numbers reveal a dangerous misconception about ovarian cancer. Many more women are diagnosed with ovarian cancer than cervical cancer. Moreover, many more women die as a result of ovarian cancer than as a result of cervical cancer. Early diagnosis is key in both instances. In this regard, being knowledgeable about these medical conditions can be a matter of life and death. Be mindful that a smear test is not helpful in diagnosing ovarian cancer.

Contributing author: Jon Stefanuca

New Research : Treadmill may help tots with neuromotor delays (such as cerebral palsy) walk

While the study group was a small one (15), researchers at the University of Michigan’s School of Kinesiology have reported supervised treadmill walking may help children with neuromotor delays.   This study was reported yesterday in an article published in The Hindu.

Rosa Angulo-Barroso, Associate Professor of movement science  at the School, and her colleagues followed 15 infants at risk for neuromotor delays over a period of two years.  They tested the changes in physical activity and treadmill-stepping performed with parental supervision in the children’s  homes.   Six of these children had been diagnosed with cerebral palsy.

“We found that in those with neuromotor delays, the pattern of development through time was parallel (but less) than normal kids.” said Angulo-Barroso. “We also found less toe-walking, so foot placement improved.” Angulo-Barroso added. The study also suggests a critical intervention window. Both children without a diagnosis and kids with cerebral palsy improved the most between 10 months and 18 months.

As The Hindu article notes, “The study, “Treadmill Responses and Physical Activity Levels of Infants at Risk for Neuromotor Delay” appears in the journal Pediatric Physical Therapy.

It would be most interesting to see if a larger, multi-center, double-blind  study could produce the same or similar results.  I haven’t personally seen the ‘tot’ version of a treadmill, but a quick search on Google images does show some interesting devices (see picture on left).  As researchers in the etiology and treatment of cerebral palsy keep working, the efforts of others such as reported here will potentially provide a wonderful interim measure toward helping these kids with special needs.  We’ll try to keep an eye on this story and will report should more information become available.