I Went The Endovascular Route
3 November 1997
First, I want to express my gratitude to Dr. Maples of the State University of west Georgia and to Dr. Tilson of Columbia University. Their Home Pages were invaluable in my search for data on Abdominal Aorta Aneurysms (AAA). The opportunity to read about other patients' experiences and their answers to my e-mail questions put me on the path to find alternatives to conventional surgery.
On 24 July 1997, I departed home 9:00am and drove 200 miles to the Miami Vascular Institute Baptist Hospital, Miami, Florida where I checked in for my Procedure (operation) to correct my 7cm. abdominal aorta aneurysm. I was "prepped" about 1:30 and about 2:00 Dr. Barry Katzen, an Interventional Radiologist arrived with a vascular surgeon to begin the Procedure. I was given an epidural sedation and was awake listening to the Procedure conversation. The vascular surgeon made the small incision in the groin area of my right leg to open the femoral artery so Dr. Katzen, the Interventional Radiologist could insert the sheath containing the Endograft made by the Endovascular Technology Company of Menlo Park, California. At 3:45, Dr.Katzen put two X-ray pictures on a large screen and asked me to look at them. One was my large distorted AAA at 2:30, and the other was my corrected AAA at 3:45----IT WAS A NORMAL APPEARING AORTA!
I was then taken to a private room for the night. My wife and daughter visited with me until it was sleep time. I had a good night's sleep. The only discomfort were staples used to close the small incision made by the vascular surgeon. The next morning I had to wait around for a follow up CT scan, blood test and checkup by doctors. The CT scan showed no leaks and everything looked great. I was ready to leave but Dr. Katzen asked me to remain another night because he wanted to look at the aorta with ultrasound. Everything looked fine and I left about 11:30 for the 200 mile drive home. I took it easy for 8 days until the incision staples were removed. Since that time there have been no restrictions placed on myself, and I have been back to playing strenuous singles tennis once and twice a day. In compliance with the FDA/Endovascular Technologies, Inc. test program, I returned to the Miami Vascular Institute 29 August for a 6 week follow up blood test and check of the pulses. On 31 October I had follow up X-rays and ultrasound. So far everything is perfect. The test program further requires that in December 1997, July 1998, and July 1999, I undergo follow up X-ray, Ultrasound, leg blood flow test, and CT scan. All of the follow up tests are paid for by Endovascular Technologies, Inc.
In 1991, a blood test indicated my bilirubin level was slightly on the high side and my doctor suggested an ultrasound to see if the liver was O.K., which it was. However, the technician said, "Do you know that you have an abdominal aorta aneurysm about 4.5 centimeters ?" A few months later I visited with the Chief of Vascular Surgery at one of our large military medical centers. A CT scan showed the AAA to be 5 centimeters and of fusiform shape. I chose to wait and have ultrasounds every 6 to 12 months to watch for any growth. By December 1996, the AAA had increased to 6cm and in May 1997 the size had increased to 6.5cm and the distance between the renal arteries and the neck (proximal) of the aneurysm was decreasing in size. I knew the time had come to make my decision.
In May 1997, I intensified my research using the Internet sources. The Endovascular Journals were most helpful. Several doctors answered my questions via Email. I visited the factory in Sunrise Florida that makes an endograft and saw the TALENT graft (not yet approved by the FDA). Since 1991, I had consulted with 5 different vascular surgeons with experience with AAA surgery. They impressed on me that because of my excellent physical condition that the best course of action was conventional surgery. the Internet made me well aware of the statistics and complications possible from this route.
From the Internet, Journals of Endovascular Surgery, etc., I became knowledgeable about the FDA approved AAA Test Program being conducted at 20 Medical Centers in the US. Although being used for several years in Europe and other countries, the only FDA approved (for test) AAA endograft was the one developed by Endovascular Technologies Inc. The test program had been underway for over 2 years and considerable statistical test results were available. I visited one of the 20 centers and consulted with the vascular surgeon conducting the FDA Endograft Test. He completely discouraged me about the graft route and felt because of my excellent physical condition, surgery was the route to take.
Back to the Internet. I discovered, just 200 miles away, another Test Center, the Miami Vascular Institute. I made an appointment for June 5, 1997 and met with Dr. Barry Katzen who had inserted the minimally invasive endograft in about 20 patients. His first words to me were "You know I am not a surgeon—I am an Interventional Radiologist". He showed me the Dacron graft, and his answers to my questions gave me the assurance that the minimally invasive endograft procedure would work. Back to the Internet to check the credentials of Dr. Katzen, the Miami Vascular Institute, and the Baptist Hospital. I was impressed and 16 June 1997 returned to the Institute for a CT scan and Angiogram. Dr. Katzen said the aneurysm and arteries looked very suitable for inserting the endograft.
On 24 July 1997, my abdominal aorta aneurysm no longer existed. The short term results have been perfect, and there is no reason to believe that the long term results should not be as good or better than the Dacron graft installed by conventional surgery.
In summary my personal observations:
The FDA Test of the endovascular graft made by
the Endovascular Technologies should be completed in less than a
year and the test results to date indicate full approval will be
granted.
To date, the testing of the graft procedure has been used mostly on
patients who were not physically fit for the the risks of
conventional surgery.
The graft material is essentially the same as used in conventional
surgery and should hold up just as well. The top of the graft is
held in place by small metal hooks that are embedded in the
aorta--much like the synthetic thread and needle used by a
surgeon.
Optimum time to correct an AAA is in the early stages of an
aneurysm, i.e. before the space just below the renal arteries
becomes too small (at least 1.5cm is desirable) and before the AAA
carrying the blood flow becomes twisted. The femoral artery where
the incision is to be made should be at least 8-9mm. All of these
measurements can be determined by standard imaging. Each person
must of course be evaluated on an individual basis.
From my personal experience I would recommend everyone around 50
years old obtain an ultrasound. the cost is usually less than $500
and will reveal the general state of the abdomen area, kidneys,
gallstone, liver cyst, and size of the aorta near the naval
area.
From my personal experience, I believe the minimally invasive
endograft will, when fully approved by FDA, become the standard
procedure to correct the "normal" abdominal aorta aneurysm. From my
layman's viewpoint it appears that the doctor best qualified to
perform the Procedure will be an experienced Interventional
Radiologist who is best qualified to read the imaging devices and
to operate the insertion devices. The vascular surgeon will always
be needed to standby in event the unusual happens.
Update 8 Dec 97
As one who is a firm believer in the noninvasive endovascular treatment for an abdominal aorta aneurysm, I will from to time give an update on my status. Before my 24 July 1997 procedure I could feel near my navel the pulsing of my aorta and a distinct bulge where the aneurysm existed. Today, I can barely feel a very small bulge where the graft is located. The substance in the aneurysm surrounding the graft has essentially been accommodated by the body. The loud pulsing of the abdomen aorta with each beat of my heart can barely be felt with the hand. The aorta in the abdomen area appears normal. I continue to fill each day with activities and aggressive tennis. I am scheduled for late December to return to Miami Vascular Institute for followup checks to include a CT Scan.
Update 28 Mar 98
On February 6, 1998 I reported in to the Miami Cardiac and Vascular Institute for my 6 month tests as required by the Federal Drug Administration(FDA). At 9:30am I had an ULTRASOUND which showed the graft was perfectly attached as in July 1997. The blood flow through the aorta was fine. at 10:30 I had an abdominal XRAY which was taken with the same measurements as the 3 month xrays taken in October 1997. The xrays showed the graft to be the same as when installed in July 1997. At 12:00 I had a CT SCAN which is the best way to observe and verify the condition of the graft inside the abdominal portion of the aorta. Again the graft was shown to be in the position as installed in July 1997. THERE WAS A DISCREPANCY: The Dr.'s report is quoted: "Endoprosthesis in place. Findings consistent with endoleak. The contrast materiel is only seen in the inferior aspect of the aneurysm sac suggestive that this leak may be arising from patent lumbar artery." This Means: At the lower part of the aneurysm sac outside of the graft there was evidence of a small trace o blood into the sac of the old aneurysm part of the aorta. This was most likely from the small branch artery that went from the aorta to the lumbar area. Prior to my decision to go the endovascular route my research revealed that during regular surgery the Aorta is opened up and the several branches leading from the abdominal aorta to the several organs, stomach, colon, spinal, etc. are cauterized or embolized off to prevent any retrograde flow of blood from the organs back into the aneurysm sac. Within a few weeks the organs develop new sources of blood. This cannot be done at this time with the endograft. However, any retrograde back flow is expected to, and usually does, seal itself by the coagulation of the slowflow of blood.
At 2:00 I had the scheduled consultation with Dr. Katzen to review the followup tests results. We were pleased to know that the graft was firmly in place and functioning as specified. We were disappointed that there was any retrograde blood flow back into the aneurysm sac at all. We agreed that there was no immediate danger and that the blood flow into the sac should seal itself off by action of coagulation or thrombosis. The FDA required followup is a CT SCAN in July 1998. At time if the retrograde leak has not sealed itself off and, it it appears to be of major concern then we will look at several courses of action to seal off the leak.
In the meantime, while I am mentally aware of the discrepancy, I fill each day with those activities essential to good health: vigorous exercise, eat the proper food, no smoking, keep mentally active, and maintain good fellowship.
Update 13 Aug 98
On 21 July 1998 I returned to the Miami Cardiac and Vascular Institute for my 12 month followup as the protocol for the EVT-FDA test program required.
Checking in at 0830, I first had a blood test
— OK.
A CTSCAN to check for any leaks — There were none. Apparently
the small one in January had sealed itself off.
An XRAY — it showed the graft materiel to be in the position
as originally installed.
An ULTRASOUND to check the bloodflow and any leaks — there
were no leaks.
1:30 PM CONSULTATION — with Dr. Barry Katzen to review the
tests. We were both pleased.
My next scheduled followup is July 1999. However, I may have an ultrasound about December to double check that everything is OK. An ultrasound is so reasonable in price and shows so very much of the abdomen area.
While in the waiting room I ran into another patient that was getting his 6 month checkup. In January while at the Institute I visited with the patient who had just the day before had the same AAA EVT procedure. Everything is apparently fine.
Just a personal observation that I expressed to Dr. Katzen. How does a person with AAA problem find skilled experienced Interventional Radiologist teams in other parts of the country like he has in Miami . It seems there is no good answer. Vascular surgeons are easy to find. I am still of the opinion that the way of the future is the minimally invasive route and the use of stents for most vascular problems. The technology is improving everyday.
Update 19 Aug 1999
Two Year Followup Update
On August 10, 1999 I returned to Miami Cardiac and Vascular Institute(MCVI) for my 2 years later followup exams. Starting at 0830 I had a blood test, ultrasound, xray, and ctscan followed by a physical exam and consultation with Dr. Barry Katzen. I am happy to report that everything pertaining to the EVT endograft I received on July 24, 1997 is performing perfectly with no problems at all. My quality of life has in no way been affected by the AAA and the procedure performed on July 24, 1999 to eliminate the AAA deficiency.
It might be of interest to know that the EVT endograft made by Endovascular Technologie, Menlo Calif. is now know as the ANCURE ENDOGRAFT SYSTEM since the company was merged with Guidant Corporation. The endograft has completed its experimental status and on 23 June 1999 at a meeting in D.C. the FDA gave approval for the use in the United States. It is no longer experimental.
You can read the entire transcript of the Board Meeting by going to this FDA page. P990017 is the premarket approval application of the Guidant Endovascular Technologies
Three Year Followup Update
On July 18, 2000 I returned to MCVI for my 3 year followup exam. As with my 2 year followup, I had a blood test for creatine levels, ultrasound to check the blood flow, an x-ray to compare the location of the endograft with the original, a CT scan to check for leaks, etc. and followup consultation.
I am happy to report that all is fine with no problems at all.
I am still glad I went the endograft route. I, of course , was one of the first to enter the FDA approved test program.
Discussion, comments, or questions: Eugene Sterling
© Copyright 2005 Eugene
Sterling
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