Behind the Scenes at the Structural and Congenital Heart Disease Program at Lenox Hill Heart and Vascular Institute-North Shore LIJ Health System

What does it mean to treat a patient with a heart team?

It means a truly integrated team. It is not just the different silos of cardiothoracic surgery, cardiology, interventionalists and so forth, and once in a while they get together to discuss a case. Instead, a heart team approach means that the evaluation of the patients, the assessment, the decision-making process, the analysis, everything, is done from beginning to end in a joint manner and the procedures are done together. That is what we emphasize and I think we are one of the very few centers where we don’t just talk the talk, but we walk the walk. Our team and program has been in place for the past several years. We have a common clinic space and we see the patients together with imaging specialists such as echocardiograpy and computed tomography (CT). Surgeons, anesthesiologists and any different specialists required, like nephrologists, are part of our team.

Could you describe your hybrid lab?

We have six cath labs with one currently dedicated structural suite. Probably by the beginning of May, we will have completed a hybrid biplane structural catheterization lab. We are also building two new hybrid cath lab/OR suites with a robotic system.

Is the structural and valvular program its own entity or is it under the umbrella of the cath lab?

The program is its own entity, and integrates cardiology, pediatric cardiology, cardiothoracic surgery, imaging (including echocardiography and CT), cardiac anesthesiology, and cardiac critical care medicine.

What are the other procedures are you performing?

We are one of the largest volume centers for percutaneous paravalvular leak and pseudoaneurysm closure. We also perform post-surgical/post-infarction ventricular septal defect (VSD) closures, left atrial appendage exclusions, all congenital procedures, percutaneous valve-in-valve and valve-in-ring implantations, etc. In addition, we perform pulmonary emboli extractions via vacuum thrombectomy. We have other teams in cardiology that do coronary and peripheral work, as well as the surgeons who do coronary artery bypass. We are truly dedicated to the treatment of structural, valvular and congenital heart disease.

Our program has the oldest dedicated structural heart disease fellowship in the U.S. Our fellowship program trains fellows in only structural and congenital heart disease, 100% dedicated to non-coronary, non-peripheral interventions.

Is there a need for more education and changes in the treatment for congenital and structural heart disease, as more and more patients are surviving longer?

Absolutely. The American College of Cardiology (ACC) and the Society for Cardiovascular Angiography and Interventions (SCAI) are both very aware of this need.

There is a council both on the SCAI and the ACC that addresses these issues. We are very conscious at the level of writing guidelines, and that is why, on the new guidelines for valvular heart disease, you will see the strong recommendation that structural and valvular procedures be performed by integrated teams with specialists, rather than relying on the concept of individual operators. Individuals can be extremely skillful and well trained, but if there is not a team behind them, the procedures will not be reimbursed by CMS. An individual operator scenario will be viewed as an outlier by everyone.

Can you share your history with the CoreValve?

The first two CoreValves implanted in the world were done in India and both patients died. Nine years ago, I did the third patient, in Venezuela. This patient was the first survival and is still alive today. It is the longest survival of a patient with a prosthetic valve. The patient is doing well. So our history goes from the very inception of the CoreValve; I was part of the animal trials in Europe, and now we are obviously on the clinical trials in the United States.

How would you differentiate the CoreValve from the Edwards Sapien valve?

Basically, the main difference is the mechanism of expansion. One is balloon-expandable (Sapien); the other (CoreValve) is self-expandable. One has pros and cons, and vice versa. The leaks seem to be more prominent with the Sapien valve; however, the CoreValve has much higher incidence of conduction abnormalities like heart block, requiring pacemakers. The indications for each cannot be attested to at this time, because there has not been a randomized trial of one against the other. There is no clear data. But it does seem there will be a subset of patients who will benefit more from a balloon-expandable valve than they would with a self-expandable valve.

I would not call the CoreValve repositionable, because it is not. However, if you have not deployed more than two-thirds of the valve, it can still be retrieved and removed, and a new one can be placed. With the balloon-expandable Sapien valve, it is a one-shot event. You inflate the balloon and that is it. The CoreValve can be deployed without rapid pacing, and has the advantage of retrieving the valve if something was not done correctly. I think the new generation of CoreValve will be repositionable, but there are also additional valves under research. There is an upcoming trial for St. Jude Medical’s Portico valve, which is repositionable, and other valves that are truly repositionable will hopefully be coming soon. These include the Lotus valve (Sadra Medical) and the Direct Flow valve (Direct Flow Medical). There have also been several iterations of the Sapien as well. Edwards now has the XT valve, and in Europe, they are starting to trial the Sapien 3 valve, which has a mantle around the valve to prevent paravalvular leaks; it is absolutely fantastic.

In light of the valve-in-valve case presented to readers, can you talk about the issues with denerative bioprosthetic aortic valves?

The surgically implanted valves are all glutaraldehyde-preserved valves, and any glutaraldehyde-preserved valve tends to degenerate and calcify. Today, there are many different processes by which the valves are pretreated to minimize calcification and degeneration, and that is why bioprostheses today have a much longer lifespan. Having said that, however, there are still bioprosthetic valves implanted that degenerate very fast. As a matter of fact, one of our recent patients had a degenerated mitral valve within six months after implant. This patient had already undergone two previous mitral valve replacements. So, it happens. It is not common, but it happens. When it happens, if the patient is high risk, one option we can now offer is a percutaneous transcatheter valve-in-valve implant, in any valve position.

We have had experience with aortic, mitral, and pulmonic valve-in-valve implants. To date, we have performed 20 valve-in-valve procedures here at Lenox Hill. We are very proud to say that we were the first to implant a CoreValve in a surgically implanted valve here in the U.S.; it has been done in Europe, but we were the first ones in the U.S.

What are the challenges with valve-in-valve cases?

There are many technical issues to be aware of regarding correct placement. Those valves that are stented valves have the tendency to ‘milk’ the valve prosthesis towards the ventricle during deployment, so you have to be very conscious of that mechanism when deploying the CoreValve. Also, depending on the bioprosthetic valve, the leaflets can occlude the ostium of the native coronary arteries. This risk requires a very in-depth understanding of the anatomy. The use of very sophisticated imaging is essential for a safe procedure.

Are there issues with pieces of the bioprosthetic valve breaking off during the procedure?

It is always a possibility. That is why we never recommend ballooning those valves pre implant. We go with a primary implant, so one of the advantages of the CoreValve, as opposed to the Sapien or the Melody, is the way that the stent is built. If there is a fragment of the bioprosthetic valve released at the time of deployment, it will be encased and trapped by the stent, and will not embolize distally.

Could you share the imaging tools you use during the procedure and how they help you?

We are very fortunate. I think we are the only lab in the world today that has two fusion imaging technologies, simultaneous in the same lab. By fusion imaging technology, I mean the ability to import the DICOM data from one imaging modality that you can then fuse and overlay on fluoroscopy. We have the ability for real-time 3D transesophageal echocardiography (TEE) imaging to be overlaid on top of fluoroscopy. As a result, we can put precise markers or landmarks on those images, whether in CT or echo, and the system will transmit that landmark onto the fluoroscopy, so when you are executing your intervention, you have very precise landmarks. In our lab, that has translated into an amazing benefit, improving accuracy whether we are deploying paravalvular leak closures, putting in devices to close pseudoaneurysms, or deploying valves.

With valve-in-valve cases, how many physicians and staff are in the room?

There are a lot of people! You have cardiac anesthesia, an echocardiographer, nurses, techs, perfusionists, and two or three interventionalists or surgeons (here I don’t differentiate backgrounds, because we operate indistinctively in the cath lab). Plus we have the CT/fusion imaging specialist. All of these people are inside the lab, approximately eight people altogether.

My philosophy is that complications are proportionate to the number of people in the room, a direct relationship. The higher the number of people, the higher the chance of complications. We keep our room as lean as possible. Everybody in the room is part of the team. Everybody knows exactly what to do and how to do it. There is true integration among team members. We have superb technologists and nurses. They are very familiar with what we do and how we do it. It is a very well-oiled machine that integrates well with the anesthesiologist.

Carlos Ruiz, MD, PhD, can be contacted at cruiz@nshs.edu.

Read more at:

First Successful Implant of a CoreValve Inside a Degenerative Aortic Bioprosthesis (Valve-in-Valve) in the United States