**4. The right time for a heart valve replacement**

While still 79 years old, my cardiologist was beginning to be concerned that the time was getting right for a replacement aortic valve. I was having more angina-like discomfort in my chest when I went for my daily walks. The echocardiogram (echo) showed that my ejection fraction had dropped from its previous reading of 55 to 45. Also, the valve opening had narrowed, due to calcification, to a dangerously narrow number using echo readings. Finally, the valve had become stenotic, that is, it was not opening and closing as it had previously. However, to my way of thinking, my cardiologist seemed slow to pursue valve replacement. He put me through a whole series of tests, including my fifth catheterization (not counting the ablation). In a discussion with him about the procedure, he explained that a team of three physicians, including himself, had been put together to access my situation. All three physicians had concerns about how successful an aortic heart valve procedure might be in my case. Some of the following parts of my story that follows at times involve my assumptions and projections about what happened, so none of the physicians involved can be held to account exactly for my views as stated below.

The surgeon on the team had determined that surgery was not an option. I met with her, and I do not recall her using the term "inoperable," but someone may have used it at least once. In any event, my understanding was that she ruled out surgery due to the extensive calcification of the valve. This is concerning because a part of her role is to be present during the TAVR procedure in case something goes wrong, and it becomes necessary to move me from the procedure room directly into the operating room. So now I'm uncomfortable knowing that if something goes wrong during my TAVR procedure that surgery is not a promising backup plan. However, the surgeon did agree that a TAVR procedure was the best option for treating my condition. Not doing anything about the valve was not a good option either. One physician estimated I had only 6 months to a year to live given the condition of my valve and the deteriorating condition of my heart as shown in the echo results.

In addition to the team's concern about surgery not being an option, the team had five other concerns about implanting a new aortic valve in my heart using the TAVR procedure. Any one of the five would be a good reason for not performing the procedure, so I'll discuss each of the five and explain why each was problematic in terms of a favorable outcome.

#### **4.1 The size of my existing aortic valve was unusually large**

My team planned to use a replacement valve they regularly used for such procedures, but the largest valve made by their preferred maker of TAVR valves was 20 percent smaller than my valve opening (i.e., the largest valve was only 80 percent in size of

what they preferred). Using the right sized valve is critically important to the success of the procedure. If the replacement valve is too large for the patient's aortic valve opening, it could severely damage the heart muscle and even cause death right there on the table. If the replacement valve is too small (my case), it could slide out of position and have a fatal outcome.

A process called hemodynamics [7] helps hold the stent supporting the valve in place in the aorta. As a normal heart pumps blood out through the aortic valve, it does so with a fair degree of velocity and force, but there is not a lot of pressure on the valve itself because the cusps are open, and the blood is flowing right through the open valve. Likewise, when the valve closes, there is not a lot of backflow pressure because the backflow of blood is not being pumped, it is simply stopped from flowing back into the heart. Still, replacement valve slippage is a concern.

Also, a process known as reendothelialization (where cells lining the blood vessels grow in and around the stent) helps hold the valve in place [8]. Finally, the metal valve frame or stent will be pressing out against the old tissue valve which is squeezed between the stent or frame of the valve and the lining of the aorta, and this will help hold the valve in place. Despite all this, a valve can slip out of place, and therefore, proper size is important. The nearest thing I can compare the importance of valve size to is clothing, a new pair of shoes for example. Even when we buy "our size" in a different shoe it can be too long, or too short, or too wide, or too narrow, or have the wrong arch support or just not feel right. For these reasons, we usually try on a new pair of shoes before we buy them to make sure they are the right size. The same goes for a pair of gloves and other clothing items. The outcome of an improperly sized replacement heart valve may come with more deadly consequences. During a catheterization procedure, physicians carefully measure the size of the old valve opening in choosing the proper replacement size. Interestingly, the replacement valves are not made to order. They are premade in a very limited number of sizes and are either available from the maker or stocked in the TAVR Centers where implantation will be taking place.

My team knew that another maker of aortic heart valves happened to make a larger size valve that would be much better for my situation. The team contacted the maker of that replacement heart valve and described my case to the maker and explained why the team wanted to implant the larger valve in my heart. The maker of the larger valve declined to allow their valve to be placed in my heart fearing that my situation was too dangerous for a replacement valve to be successful.

If the team was to go ahead and attempt my aortic valve replacement procedure, they would need to use a valve they regularly used and had access to even if the valve was too small. There were a couple of advantages in the team's favor. The valve they usually used had a section in the middle of the frame that allowed for expansion of the valve using a balloon catheter. In other words, once the valve had been deployed in my heart, they could then insert a balloon catheter into the valve and expand it outwards in the middle of the valve. However, they could not make up being 20 percent too small. In addition, the valve comes with a "skirt" designed to expand and lessen blood around the outside of the frame. The "skirt" could prove helpful should they go ahead with the procedure. Finally, the team reasoned that the extensive calcification would likely hold the valve in place even if all else failed.

#### **4.2 My aortic valve had an unusual shape prone to leakage**

As opposed to being round or somewhat oval shaped, like most aorta valves, my valve is elongated and shaped more like a football. My team was worried that if they put a round replacement valve inside an elongated space that there would be an unacceptable amount of blood leaking back into the heart around the frame of the valve. This is commonly referred to as regurgitation or aortic insufficiency (AI). My team did not want to operate and create a new major issue due to an unacceptable amount of blood leaking back into the heart with each heartbeat.

## **4.3 The cusps of my valve were deformed**

The newer and higher quality echo device at the hospital where my cardiologist performed my last echocardiogram to help determine if I was a candidate for a TAVR for my aorta valve, finally showed the deformity of my valve from birth. Typically, the aorta valve has three cusps that open and close with each heartbeat. I only had two cusps. The third cusp was missing. I was not a classic bicuspid valve case. In addition, my two cusps were fused together, so I really had only one double-sized cusp that was opening and closing with each heartbeat. Instead of the valve opening and closing normally, it was moving more like a small door opening and closing in a large door frame. The team was concerned about how compliant the large and fused cusps might be when the replacement valve was deployed.

#### **4.4 My aortic valve had extensive calcification**

My team was especially concerned about how pliant the calcification in the aortic valve would be. They were worried that if it was too hard that it might damage the heart muscle when the replacement valve was deployed. However, as previously mentioned, the team thought the calcification might help hold the undersized replacement valve in place.
