My FDA clinical trial

***Warning: long rambling backstory***


About 9 years ago, my family and I drove to Myrtle Beach. We stopped for the night at Smithfield, NC. just a few hours away from our destination. We had a nice dinner, then went to bed. About midnight, I got up to pee, and felt a stabbing pain in my groin that dropped me to my knees. I have never felt such intense pain, and thought I had somehow been shot. The actual cause was much lass dramatic: kidney stones, the result of untreated high blood pressure, uncontrolled blood sugar and a slight bladder infection. I spent the night in a hospital, complete with urinary catheter. The next day they pumped me full of drugs and sent me on my way. Two weeks later, I was still having residual pain in my kidney, so my Dr. ordered a CT scan. At which point he discovered that my kidney was fine, but I had an Thoracic/abdominal aortic aneurysm. Basically, a bulge in the main artery from your heart to your major organs and legs. Mine is large and hourglass shaped. Pushing 5.2cm - normal is 2cm, and it's considered aneurysm at 3cm.

Since that time, I have had to undergo a ultrasound scan of the aorta, every six months. Not much more than mildly uncomfortable, and it gets me off work for a few hours (plus the techs are usually fairly attractive women). Then I meet with a vascular surgeon, and we talk about how much it has grown, and how long before it needs to be fixed. Well, the last scan I had was labeled "results inconclusive" by the ultrasound tech. Simply put, the numbers were too close to call with this type of scan. So, they sent me off for yet another CT scan. That was last week. Then the doctor called me. His first words to me were, "it's time". I won't bore anyone with the details of the surgery, but it's not like I have a choice. They call it the 85% club: something like 85% fatality if it ruptures, and something like 85% over 5.3cm will rupture. So, fix it or die.

That all happened last fall. My vascular surgeon, in describing the traditional method of repair (called open surgery), said it would take 3-9 months of recovery and be quite painful. It basically involves cutting your entire abdomen open, pushing everything aside, and sewing the aneurism together like a quilt. 6-8 hours of very dangerous surgery. It is considered the most complicated operation performed here in Rochester, and this is the home of heart transplants.

He then mentioned a colleague of his up in UMass at Worcester, MA that had a new method of repair. Using custom made stents, they would go in through the groin and put tubes in place. Stents are proven, and this new, custom made part using CT scans means it's tailored just for me. Since it's so new, it is an FDA sponsored clinical trial, and they just passed 100 patients last December. 91.5% success, which doesn't sound all they great until you realize this surgery entails patients where open surgery would kill them. So last resort type of thing.

Anyway, first surgery for me was in December. Two small (1/4") cuts in my groin, and 6 days later I'm back at work like nothing happened. Then, earlier this month I had the second, more serious surgery. Two large incisions in my groin (~6" long), one in my right shoulder, a lumbar/spinal drain, and lots of IV insertion sites. Here it is not quite 2 weeks later and I'm doing fairly well. Up and about, not a lot of pain, and hopefully my aorta is fixed. That's a hell of a trade-off from 3-9 months of recovery.

I will continue to have CT scans on a regular basis to make sure everything is holding up. Most of that will be accomplished here in my hometown, so no more 5.5 hour drives to Mass.

Oh, and one last thing: the #1 cause of aneurisms is tobacco use. STOP smoking!