Angiogenesis

[Don From Florida]

I would like to know how the trials are going with the Angiogenesis (gene therapy injection of VEGF). I have read that the outcome of some trial facilities are not that promising, due to the results of some of the patients. Is it true that the placebo patients averaged the same relief of angina as the patients that recieved the injections of the VEGF gene? Are there any results to date showing an improvement in perfusion along with relief of angina?

Most of the reports that i have read seem to be from 1998 and not current. Are the results any better, and if so does the Cleveland Clinic in Florida participate in these trials?

Thank You & Best Wishes To Everyone,
Don

[Cleveland Clinic, MD]

Dear Don,

Yes, you are correct.  The results of VEGF trials so far have been disappointing.  The largest trial to date has been the VIVA trial which showed no improvement in symptoms or perfusion.  There is at least one trial now ongoing using a different delivery system for the VEGF that includes the use of TMR but the Clinic is not participating in this trial.  So for now we are still looking for better answers for people like you. Good to hear from you and best wishes.

[Don From Florida]

Thank you for your quick response to my questions and concerns on Angiogenesis.

This is the first that i have heard on including VEGF somehow during the laser procedure transmyocardial revascularization (TMR). The concept sounds good to me being both procedures are done to create channels for new bloodflow to area's of the heart that are deprived due to CAD.

My situation indeed will require one or both of these procedures (or something simular) in an effort to relieve the angina. I only have the "LIMA" left at this time, as all other graphs have completly occluded & are to diseased to bypass again. It was attempted in August 1999 but could not be done at all.

I have researched TMR over the last few years, and have come to the conclusion that it would not benefit me other than a possible relief of the angina only. The reports i've read indicate that perfusion does not improve, and how long the channels remain patent is still unknown.

I look at this procedure of relieving only angina with caution. To me, angina is a warning to your body that you are overloading your heart. If the TMR removes this warning by creating small cappillary arteries, and killing the nerve endings in that portion of the heart, it would be the same to me as:

(Removing the "Stop Signs" from a 4 way intersection. The danger of oncoming traffic would still be there, but you would have nothing to warn you of the danger you are approaching.)

I apoligize for the simple analogy, but that's where at i'm at to date with this research.

Hopefuly soon something will turn up for patients such as myself who have no other options for revascularization.

Thank You Again, And Best Wishes To Everyone,
Don

[Bill Serrahn]

I had a failed angioplasty last July after suffering an M.I.  I was left with a totally occluded RCA, which according to my cardiologist, had been blocked for some time.  The options given to me at the time were bypass surgery or live with it.

The interesting thing, and probably the reason that I didn't know that I had this blockage, was that a moderate network of collateral vascularization had developed in response to this blockage.  There is a small artery going from my LDA across to the lower right and a natural bypass, following a tortured route around the RCA blockage.

I believe that this vascularization developed (via VEGF production) as a response to ischemia, so I have been hoping that I could keep it going by exercising up to a slightly ischemic condition without going far enough to have another M.I. or cause further damage to the myocardium.

My RX for this condition has been walking uphill everyday.

I bought a heart rate monitor and started doing daily hikes.  At first, I found that I would start encountering angina symptoms at any steady exersion producing a HR over 110 BPM, so I would hike uphill until my HR was 100-105 and maintain that.  If I went over 110, I would stop for a few seconds.

I was able to steadily increase my ability over the last year and now rarely have symptoms of angina, and those occurances are usually due to stress.  I can now hike or back-country ski 10 or 12 miles and go up and down a few thousand feet without overdoing it.  I can now do a lot more with a H.R. under 110, and still rarely exceed that.

I have also found that a very small amount of Atenolol (15 MG) each morning is helpful, but more was counterproductive.

Of course I am on a Statin drug (Lipitor) and on a BP med (I choose the ACE inhibitor Accupril, because of it's purported rejuvenating effect on the Endothelial cells).

Whether I have enhanced my natural bypass or not, I really don't know at this time.  I do feel a lot better and can do a lot more.  I assume that this may mean that I have better perfusion beyond my occluded RCA.  

I had an opportunity to have my RCA occlusion removed in Canada with a new laser angioplasty designed to get through lengthy total occlusions, but I guess that I no longer feel that it's that important to remove it.

Anyway this summer, after some training to further build up my high altitude endurance, I plan on climbing Mt. Adams (12,276').  I expect to do that without pushing my H.R. past 110, one step at a time.  

If you have blocked arteries, exerting yourself at higher altitudes is a risky practice.  I do believe that the cardiovascular system responds and compensates for high altitude, if it is given enough time to acclimate.  I am hoping that spending about six weeks slowly building up high altitude endurance will enhance this neo-vascularization.

I realize that it may be dangerous for someone with advanced left main disease to do what I have done, and that they may not be able to increase their exercise endurance significantly.  And of course the jury is still out on my case - I could drop dead on my afternoon walk today.  I do believe that walking uphill every day as much as you can tolerate and as slowly as you have to go, is about the best thing currently available to stimulate VEGF production.

[Don From Florida]

Bill S.......Thank you for the response. It seems your doing pretty good with your cardiovascular improvement with the up hill walking, and i wish you continued success.

However, my case differs somewhat from yours, and it leaves me in a difficult situation. Having only 1 artery left (the mammary) for blood-supply makes it just a little short of impossible to do much walking for any distance without having severe angina. This was the reason for the "Re-Op" attempt in August 1999. At that time the surgery was started, along with the removal of the vien graphs (back of both legs)before it was discovered that the disease was to advanced to continue, and i was just closed back up. The surgeon explained to me that he tried every way he could, but there was just nothing to graph to. This was a surgeon that normaly operates on small children, and is used to working with very tiny arteries.

To add to this, i also have 3 herniated disc in the lower back from a work injury in 1990 which limits my mobility. I do have various excersise equipment here though, and one of them being a tread-mill. I try to use it to some degree, but as expected the time is very limited before the angina & back pain are to much to continue.

Hopefuly soon medical science will figure out how to attach the VEGF gene to the perfect virus gene, and will be able to help patients with this condition.

Good luck to you again & best wishes to everyone,
Don

[Bill Serrahn]

Hi Don,

I'm sorry to hear about the failure of your surgeons to do further bypass.  It must have been very disappointing.

When my cardiologist told me that the bypass would be good for an average of 7 years, but could be good for a long as 15, I wasn't too impressed.  Being 50 years old, I certainly didn't look forward to the fact that, my odds were, having that done again at age 57.

Perhaps you could still benefit from laser angioplasty.  I investigated the Prima FX Laser Wire, which is approved in Europe and Canada, but not here in the U.S.  Dr. David Hilton, in Vancouver, BC seems to be very skilled at using this and is having very good success with it.

If it does come to that, I will go for the laser angioplasty before bypass.  Hopefully, I will be able to stay away from cardiologists and cardiac surgeons altogether.

[Tom Riedman]

Dear Bill and Don:
Sorry to here of your chronic angina. I would suggest that you investigate EECP, enhanced external counterpulsation. It is a non-invasive therapy for improving collateral coronary circulation, especially for people suffering with chronic angina. Visit www.eecp.com or www.naturalbypass.com for more information. About 5000 people have been treated since 1995 and about 75% improve with less chest pain, and a greater exercise capacity. Most of the patients treated have had previous bypass surgery and/or angioplasty. Medicare pays for it as do a number  of of other health insurances. Maybe it can help you.Good luck. Sincerely Tom

[Don From Florida]

I have looked in to the procedures both of you have mentioned. The laser angioplasty can't be done on arteries with occlusions the total length (or i was told this in an email reply).

The EECP was sent to me about a 2 years ago, and i looked through all the information i could find on it, including sending the links to (1) of my cardiologist. He wasn't to impressed with the idea of cups applying pressure to break loose the occlusion.

All of the (4) cardiologist that are envolved in my case (2 just for review) agree now that TMR or VEGF gene therapy might be the only option left, if the investigational trials prove to benefit heart perfusion along with relief from angina. To date their is no documentation that supports the perfusion improvement, but we're hopeful.

Thaks again for the response, and as always best wishes for everyone.

Don

[Thomas Riedman]

Dear Don: Glad you looked into EECP. To clarify though, EECP involves 3 sets of bladders that inflate increasing the flow of blood into the coronary arteries, then cuffs deflate before the heart contracts, reducing cardiac workload. The premise behind its action is by enhancing coronary collateral blood flow to induce a natural bypass effect around arterial blockages. EECP does NOT break loose the occlusion as you stated. It stimulates and improves collateral blood flow in the heart muscle. Improved perfusion has been demosntrated on thallium stress tests. There has been a lot of new research on EECP in the last two years including the multicenter, randomized, sham-controlled study which was released last summer. The treatment is totally non-invasive and is very low risk. Maybe your cardiologist should take another look. Good luck. Tom

[John]

What is EECP? Teweb site eecp.com does not seem to explain the procedure

[Thomas Riedman]

Dear John:
EECP stands for enhanced external counterpulsation which is a non-invasive treatment for chronic stable angina, chest pain caused by coronary artery disease.Try www.naturalbypass.com for an explanation.Take care, Tom

[Richard]

Don:  I have been following TMR and EECP, am not a doctor or enven in the medical field, for some time and suggest that your cardiologists revisit both procedures.  The cupping thing breaking loose clots just doesn't sound like EECP. As for perfusion and TMR, there are actually two TMR systems approved by the FDA,each one uses a different type laser.  One is marketed by Eclipse Surgical and the other by PLC Medical Systems.  Some of the trials with the PLC system indicate increased perfusion.  Your cardiologist can best determine what is best for you, and perhaps neither TMR or EECP is appropraite in your case, but I strongly suggest that you ask the that he or she expain the basis for their opinions.  In general, I belelieve that EECP, the less invasive option, should be persued in a non CABG situation such as yours.

By the way, all three of these procedures have been approved during the last year by the FDA, HCFA and many private insurance companies. Good Luck.

Richard

[Richard]

Don:  I have been following TMR and EECP, am not a doctor or enven in the medical field, for some time and suggest that your cardiologists revisit both procedures.  The cupping thing breaking loose clots just doesn't sound like EECP. As for perfusion and TMR, there are actually two TMR systems approved by the FDA,each one uses a different type laser.  One is marketed by Eclipse Surgical and the other by PLC Medical Systems.  Some of the trials with the PLC system indicate increased perfusion.  Your cardiologist can best determine what is best for you, and perhaps neither TMR or EECP is appropraite in your case, but I strongly suggest that you ask the that he or she expain the basis for their opinions.  In general, I belelieve that EECP, the less invasive option, should be persued in a non CABG situation such as yours.

By the way, all three of these procedures have been approved during the last year by the FDA, HCFA and many private insurance companies. Good Luck.

Richard