Standard Heart Therapiesverses

Stem Cell Heart Therapies

Proposal By: Djinni Yancey

July 2014

My eleven year old son Isaac was born with several birth defects, his heart is the most serious of all defects. His heart defects include, Hypoplastic Right Ventricle, with Dextrocardia, Pulmonary Stenosis, VSD, and Tricuspid Valve Regurgitation. Isaac has already endured three heart surgeries. Someday in the future Isaac and I may be faced with the decision to have Isaac undergo treatment to repair his leaky tricuspid valve, or possibly have him listed for a heart transplant. At this time there are only a few options available for treating Isaac’s heart issues since he is still a child. Isaac’s cardiologist currently believes that fixing Isaac’s leaky tricuspid valve is not worth the risk of repairing unless it becomes more severe. The more choices that are offered to Isaac as a patient, allows Isaac more control of his own health and quality of life. As I have been looking into various options heart patients like Isaac have, I believe stem cell heart therapies, are a better alternative than standard heart therapies.

Heart TherapiesI have chosen a few Heart Therapies as soluti onsout of many available remedies. The treatments

l isted were chosen with Isaac and his currentheart conditi on in mind.

Standard

• Pacemaker• Stent• Tricuspid Valve Repair• Heart Transplant• Comfort Care

Stem Cell

• Biological Pacemaker from Pig Heart

• Stem Cell Injection• Ghost Heart

Standard Heart TherapiesO ft e n p e o p l e a s s o c i a t e h e a r t p r o b l e m s w i t h a d u l t s . A c c o r d i n g t o t h e A m e r i c a n H e a r t A s s o c i a ti o n , “A n e s ti m a t e d m i n i m u m o f 3 2 , 0 0 0 i n f a n t s a r e e x p e c t e d t o b e a ff e c t e d e a c h y e a r i n t h e U n i t e d S t a t e s . O f t h e s e , a n a p p r o x i m a t e 2 5 % , o r 2 . 4 p e r 1 , 0 0 0 l i v e b i r t h s , r e q u i r e i n v a s i v e t r e a t m e n t i n t h e fi r s t y e a r o f l i f e .” C o n g e n i t a l H e a r t D e f e c t s a r e t h e m o s t c o m m o n b i r t h d e f e c t . C u r r e n t l y s t a n d a r d h e a r t t h e r a p i e s a r e t h e m o s t c o m m o n p r o c e d u r e s f o r a d u l t s a n d c h i l d r e n . ( “ S t a ti s ti c a l F a c t S h e e t o n C o n g e n i t a l C a r d i o v a s c u l a r D e f e c t s ” 2 0 1 3 U p d a t e , A m e r i c a n H e a r t A s s o c i a ti o n )

Pacemaker

Pick, Adam. “Pacemaker Heart Valve Surgery,” Illustration, Nov 8, 2010.http://www.heart-valve-surgery.com/heart-surgery-blog/2010/11/08/pacemaker-maze-procedure-after-heart-valve

The Nati onal Heart Lung and Blood Insti tute explains that a pacemaker is a device used to control abnormal heart rhythms. The device sends electronic pulses to the heart to keep it beati ng at a normal pace. Permanent Pacemakers are surgical ly placed inside a pati ent. Usual ly pati ents recover in a couple of days (“What is a Pacemaker?” ). Some of the r isks include a col lapsed lung, nerve or blood vessel damage, bleeding, swel l ing , bruising , and infecti on (“What are the Risks of Pacemaker Surgery ”).

The Pros and Cons of PacemakersPros• A regular heartbeat• Living a more active lifestyle.• The battery can last up to 15

years.• The surgery is minimally invasive.• Most patients only need an

overnight stay at the hospital.• Many patients return to their

normal activities within a few days of surgery.

Cons• The average battery life is

approximately 6-7 years.• Other devices such as microwaves,

cell phones and MP3 players, can interfere with its operation.

• The wires can become broken or dislodged.

• The patient may need to avoid contact sports.

• Some medical equipment can interfere, such as MRI’s and Electro cauterization used in surgery to control bleeding.

“Pacemakers” National Heart, Lung and Blood Institute

Stent

“Restenosis of a Stent-Widened Coronary Artery.” Figure A shows the coronary arteries located on the surface of the heart. Figure B shows a stent-widened artery with normal blood flow. The inset image shows a cross-section of the stent-widened artery. In figure C, tissue grows through and around the stent over time. This causes a partial blockage of the artery and abnormal blood flow. The inset image shows a cross-section of the tissue growth around the stent. http://www.nhlbi.nih.gov/health/health-topics/topics/stents/printall-index.html

The Heart, Lung and Blood Institute describes a stent as either a metal coil, or a mesh tube made out of fabric or metal. The purpose of a stent is to improve blood flow through an artery, by widening the narrow or blocked areas. Stents can also strengthen weak areas of an artery. Some stents have medication on them that is released continuously to prevent blockage. Stents are placed surgically through a catheter in the groin or neck. Risks include bleeding at the site of insertion, infection, the dye can cause an allergic reaction and/or damage to the kidneys (“What is a Stent?”).

Pros and Cons of Stents• Increase in oxygen saturation.• Improved energy for patient.• Lowers the risk of stoke and heart

attack.

• May require changes in lifestyle such as diet, exercise and smoking cessation.

• Blood Thinners will be required for most patients.

• May develop blood clots around stent if blood thinners are not used.

• Risk of damage to artery.• Risk of bleeding during or after

surgery.• Dyes used during procedure can

cause an allergic reaction.

Tricuspid Valve RepairThe Heart and Vascular Institute at John Hopkins Medicine explains how the Tricuspid valve can become damaged from a variety of causes such as pulmonary stenosis or an enlarged heart ventricle. According to Dr. Patrick McCarthy a tricuspid valve surgeon from Northwestern Medicine, a leaky tricuspid valve gradually develops heart failure. The disease is quiet at first, but over time the patient develops heart failure.” The tricuspid valve is usually treated when symptoms become severe, due to the high risks associated with surgically repairing the valve. Cardiologists at Cleveland Clinic state that an annuloplasty ring is most common surgical approach for tricuspid valve regurgitation (“Surgical Management Tricuspid Valve Repair”).

Illustrations courtesy of Cleveland clinic http://my.clevelandclinic.org/heart/services/surgery/tricuspid-valve-surgery.aspx

Pros and Cons of Tricuspid Valve Repair

Pros• It can prevent further heart

damage.• Since a patients own tissue is

used, there is no rejection.• Better survival rates than

mechanical valve replacement.• Improved quality of life.• Live a more active lifestyle.

Cons• It is a open heart surgery, which

means the patients heart has to be stopped during surgery and placed on a heart-lung bypass machine.

• Open Heart surgery is a very major surgery with many risks.

http://www.hopkinsmedicine.org/heart_vascular_institute/conditions_treatments/treatments/valve_tricuspid.html http://www.heart-valve-surgery.com/heart-surgery-blog/2013/11/05/tricuspid-disease-dr-patrick-mccarthy/http://www.heart.org/HEARTORG/Conditions/More/HeartValveProblemsandDisease/Problem-Tricuspid-Valve-Regurgitation_UCM_450617_Article.jsp http://my.clevelandclinic.org/heart/disorders/valve/tricuspid.aspx

Heart Transplant

The University of Southern California Keck School of Medicine explains that when a patient is in congestive heart failure, they may be listed on the list for a heart transplant. When a donor with a matching organ dies, the patient is contacted and the transplant process begins. The new heart surgically replaces the existing heart with the donor heart within a few hours (“Patients Guide to Heart Transplant Surgery” ).

Pros and Cons of Heart Transplant

Cons• Someone else has to die in order

for the patient to live.• Patients need to take

immunosuppressant drugs to reduce chance of heart rejection.

• Immunosuppressant's can increase the odds of cancer.

• The side effects from the various prescriptions can greatly affect the quality of life for a patient.

• Most Insurance companies do not pay for the heart to be harvested from the donor and transported.

“Patients Guide to Heart Transplant Surgery” The University of Southern California Keck School of Medicine “Heart Transplant Education Manual” Children’s Hospital of Philadelphia, Cardiac Center

Pros• Quality of life can improve.• Patient can enjoy an active

lifestyle.• Some patients have very few side

effects.• The new heart can allow a patient

to feel better than ever before.• The heart of a deceased donor

continues to beat inside the recipient until the heart fails, or the patient dies allowing the grieving family to hear the heartbeat.

Cons continued

• The cost to harvest and transport is usually over $25,000, which must be paid in advance.

• The patient usually has to make some extreme lifestyle changes.

• Some of the prescriptions required, lower the bodies ability to fight off infection and disease.

• Biopsies of the heart are a standard procedure each time a transplant patient has symptoms of possible rejection.

• The high cost of the prescriptions required are not always covered by insurance.

Pros and Cons of Heart Transplant

“Patients Guide to Heart Transplant Surgery” The University of Southern California Keck School of Medicine “Heart Transplant Education Manual” Children’s Hospital of Philadelphia, Cardiac Center

Comfort Care

The National Institute on Aging defines Comfort Care as a compassionate, end of life stage of medical care. It caters to the needs of the patients, mental and emotional needs, as well as physical comfort. It is a personal way to live the end of an individuals life. The health care providers can give medicine for pain, or oxygen to help breathing. A patient may need counseling or other therapy such as music or massage, to deal with end of life issues (“End of life: Helping With Comfort and Care, Providing Comfort at the End of Life).

Stem Cell Heart TherapiesAs research progresses, gradually stem cell therapies will increase. Adults are usually the first humans to be involved with clinical trials. Currently I could not find any stem cell heart therapies being done on children. However, there is a possibility stem cell therapy will be available for children in the future, although it is very difficult to predict at this time. Due to the main fact that much of the stem cell heart therapies are in the early stages of development, It is not possible to list all of the Pros and Cons for the research which currently has not been tested on humans.

Biological Pacemaker from Pig HeartOn December 16,2012, researchers at the Cedars-Sinai Heart Institute in Los Angeles, California, announced a new replacement for the electronic pacemaker in humans. Researchers discovered a way to create a “Biological Pacemaker, ”using gene therapy. The researchers used very small section of a pig heart smaller than the size of a pea, created a ”sino-atrial node,” which acts as the group of neurons normally serving as the natural pacemaker of the heart. They injected a new gene called TBX18 into the pig heart, converting ordinary heart cells into specialized cell which changed the heart cells into a new pacemaker. Pigs were used in the study due to similar shape and size of human hearts. After approximately two days of the treatment, the pigs hearts were already much stronger than the group of pigs untreated. In approximately three years, researchers hope to begin trials in humans, although results can be different. These new “biological pacemakers,” could replace the mechanical ones in humans in the future (“Ordinary Heart Cells Become "Biological Pacemakers" with Injection of a Single Gene”)

Ghost Heart“Ghost Heart” Photo. Courtesy of Dr. Doris Taylor. Texas Heart Institute. http://www.stemcellcite.com/stemcell/texas-heart-institute

PBS NOVA Video that inspired me to do this research. (Length 13:35 min) https://www.youtube.com/watch?v=jLs8DeHVkec

Dr. Doris Taylor, Director of Regenerative Medicine at Texas Heart Institute has been working with pig hearts to find a better alternative to the traditional Heart Transplant. Dr. Taylor and her team of researchers discovered that cells can be washed away from a donor pig heart, creating a framework for a new heart. This framework can be injected with hundred of millions of stem cells from the patient needing the transplant, and after a period of several days A new heart beats, ready for a transplant. Dr. Taylor states that due to a patients own stem cells being used, there is no chance for rejection, which eliminates the need for biopsies and immunosuppressant drugs after the transplant (“Ghost Heart, a Framework for Growing New Human Hearts”).

Stem Cell Injection

In a set of online videos at University of Utah Health Care, cardiovascular Center Dr. Amit Patel discusses the human stem cell trials going on currently in cardiology at the University of Utah Hospital. The patients involved in the trials are generally experiencing cardiomyopathy , or congestive heart failure. Dr. Patel says that stem cell therapy is sometimes a patients last hope, since they do not meet the criteria for a heart transplant. Dr. Patel explains how only about two tablespoons of stem cell blood is collected from the patient for the stem cell treatment. A patients own stem cells are injected into the heart, allowing the patients own stem cells to heal the damaged heart. He explains that the healing process is much quicker than other standard heart procedures and very little risk to the patient. (“Heart Stem Cell Therapy”).

Dr. Amit Patel discusses Stem Cell Therapy. Photo is courtesy of kannadigaworld.com

Pros and Cons of Stem Cell Therapy

Pros• Using a patients own cells

eliminates the possibility of rejection.

• No need for the immunosuppressant drugs.

• Quicker recovery time• No waiting on a transplant

list for a perfect match.• Fewer medications required.

Cons• There is always criteria for a

patient to be a candidate for any heart therapy.

• This therapy will be available for adults only for an undetermined length of time.

• Many children needing a new heart will die before this is available .

Why Stem Cell Heart Therapies are better

•Stem Cells come from a patients own body, eliminating rejection of the foreign object implanted such as a mechanical device or a transplanted organ or part.•Stem Cells allow the body to heal itself.•Stem Cells are more of a natural way of healing.•Recovery from stem cell heart therapy is usually quicker.•Less chance of repeating a surgical procedure.•No stress from waiting for the perfect organ.•Less guilt about someone dying in order to save my childs life.•No need to raise a large sum of money to pay for some of the transplant costs.•Less likely for my son to need a heart biopsy.•Stem Cell therapy is much less invasive.

ConclusionAs I reflect upon the many alternatives available in standard and stem cell heart therapies, I realize that if stem cell therapy is not available when my son Isaac is in heart failure, I will possibly choose comfort care. Comfort Care is a difficult choice in some ways, although it is comforting to know that it can be a beautiful way to bring closure at the end of a long journey. I am also prepared to travel to another hospital where Isaac will get the best care for his individual needs. The decision will be Isaac’s ultimately, he will decide what he feels is best along with consideration from his doctors, parents, siblings and his personal feelings. Whether Isaac ever needs any of these treatments or not, the information is valuable to the heart community we belong to. Many children can be saved through the research and developments in standard heart therapies as well as stem cell research. Health care is as unique as the individuals who use it. I know Isaac well enough to know that if the opportunity arises for stem cells to have a chance to heal Isaac, we will consider it with great thought and consideration.

Works Cited• “End of life: Helping With Comfort and Care, Providing Comfort at the End of Life,” National Institute on

Aging. U.S. Department of Health and Human Services, 19 May. 2014. Web. 30 July. 2014• “Heart Transplant Education Manual” Children’s Hospital of Philadelphia, Cardiac Center. Web 30 July.

2014.• “Ordinary Heart Cells Become "Biological Pacemakers" with Injection of a Single Gene,” Cedars-Sinai

Institute. 8 Jan. 2013. Web. 30 July. 2014.• “Patients Guide to Heart Transplant Surgery” University of Southern California Keck School of Medicine,

Web 30 July. 2014• Suchetka, Diane, The Plain Dealer, “Ghost Heart, a Framework for Growing New Human Hearts, could be

answer for thousands waiting for a new heart.” Texas Heart Institute, Stem Cell Cite. 19 Aug. 2012. Web 30 July. 2014

• “Tricuspid Valve Surgery,” John Hopkins Medicine, Heart and Vascular Institute. Web. 30 July. 2014.• “What are the Risks of Having a Stent?” National Heart ,and Blood Institute, U.S. Department of Health

and Human Services, 17 Dec. 2013. Web. 30 July. 2014.• “What are the Risks of Pacemaker Surgery?” National Heart, Lung and Blood Institute. U.S. Department of

Health and Human Services, 28 Feb. 2012. Web. 30 July. 2014.• “What is a Pacemaker?” National Heart ,Lung and Blood Institute. U.S. Department of Health and Human

Services, 28 Feb. 2012 Web. 30 July 2014.• “What is a Stent?” National Heart ,and Blood Institute, U.S. Department of Health and Human Services, 17

Dec. 2013. Web. 30 July. 2014.• “Heart Stem Cell Therapy,” University of Utah Health Care, Cardiovascular Center.