Transcatheter “Valve-in-Valve” Procedures: What Should Patients Know?
Published: September 24, 2020
In a perfect world, patients who undergo heart valve surgery will never need another operation. Unfortunately, this is not a perfect world.
The reality is that heart valve re-operations may be a vital part of the lifelong treatment of valvular disease as both mechanical and tissue valve replacements can fail. For this reason, I wanted to answer your questions about the latest advances specific to the use of “Valve-in-Valve” therapies for heart valve replacement re-operations. As you may know, these next-generation transcatheter devices have already helped several patients in our community including Paul Powers and Jesse McBride.
In our new “Surgeon Q&A” video below, I was lucky to interview Dr. Chris Malaisrie about Valve-in-Valve procedures. Dr. Malaisrie is a leading cardiac surgeon at Northwestern Medicine that specializes in the use and research of transcatheter devices. In our community, Dr. Malaisrie is a long-time supporter who has successfully treated many patients including Janis Kielbasa, Nicolas Busch and Ronald Rock.
Key Learnings from Dr. Malaisrie
There were so many great points about Valve-in-Valve procedures shared by Dr. Malaisrie in this video. Here are some key learnings that I jotted down:
- On a personal note… Dr. Malaisrie has specialized in heart valve disease given the evolution of therapies that include new, minimally-invasive technologies that can be “life-restoring” for patients struggling with valvular defects. Innovation is a core part of Dr. Malaisrie’s practice that integrates many advances including smaller incisions, auto-knotting techniques, sutureless valves and transcatheter devices.
- Less-invasive therapies have created benefits for patients including accelerated recovery, lower exercise restrictions and shorter hospital stays.
- Transcatheter therapies – including transcatheter aortic valve replacement (TAVR) – have transformed Dr. Malaisrie’s approach to treating valve disease. Specifically, Dr. Malaisrie believes that Transcatheter Valve-in-Valve devices are an excellent therapy for patients with failing tissue heart valve replacements.
- Valve-in-Valve therapies can be used for failing aortic, mitral, tricuspid and pulmonary valves and is the preferred treatment choice for Dr. Malaisrie. The most common Valve-in-Valve-therapy performed by Dr. Malaisrie is an aortic Valve-in-Valve procedure.
- The Valve-in-Valve therapy is not an open heart surgery and does not require an incision to the patient’s chest or ribs. During a Valve-in-Valve procedure, patients do not need to be on the heart-lung machine and patients are not required to be under general anesthesia.
- Not all patients are candidates for a Valve-in-Valve procedures. Patients who have a previously implanted mechanical valve, infected valve, and/or leakage around the failing valve are not candidates for a Valve-in-Valve procedure.
- Valve-in-Valve procedures are currently FDA approved for failing tissue valves in high-risk patients. Several clinical trials are underway for lower-risk patients. Dr. Malaisrie and the team at Northwestern Medicine are currently working on those research studies.
- Dr. Malaisrie advises patients with failing tissues valves to consult their cardiologist and previous cardiac surgeon to get the appropriate tests (e.g. echocardiogram) performed to determine if a Valve-in-Valve procedure may be appropriate for them.
Thanks Dr. Malaisrie & Northwestern Medicine!
On behalf of our patient community, I would like to extend a tremendous “Thank You!” to Dr. Malaisrie and the entire team at Northwestern Medicine for their ongoing pursuit of healthy heart valves using transformative technologies including Valve-in-Valve therapies.
- From Bedrest to a “Valve-in-Valve” Procedure, This Is Jesse’s Story
- 10 Years & 3 Heart Surgeries Later, Paul Celebrates His Mitral “Valve-in-Valve” Replacement
Keep on tickin!
P.S. For the hearing impaired members of our community, I have provided a written transcript of my interview with Dr. Malaisrie below.
Adam Pick: Hi, everybody, it’s Adam with heartvalvesurgery.com. We have a special surgeon Q&A for you today all about the advances in heart valve therapy. Specifically, we’re going to be talking in valve-in-valve therapies. Very fortunate to have on the line with me, I’m going to bring him in, Dr. Chris Malaisrie from Northwester Medicine Chicago. Great to have you with us, as always, Dr. Malaisrie – so everybody out there knows, Dr. Malaisrie is a leading cardiac surgeon at Northwestern Memorial Hospital.
He’s also a Professor of Surgery at Northwestern University. In our community, Dr. Malaisrie has helped many patients. Particular to this discussion, he has really helped out folks like John Gerlits, who had transcatheter valve therapy and Paul Powers who had valve in valve therapy. To get started, Dr. Malaisrie, could you maybe talk about why, out of all the things in cardiac surgery, why have you focused on valve therapy to be such an important part of your practice?
Dr. Chris Malaisrie: The treatment of valve disease is constantly evolving with new techniques for valve repair and minimally invasive approaches. This is why I’m most drawn to valve surgery within cardiac surgery. Valve replacement has been a life-changing therapy for patients with aortic stenosis and tight valves. Recently, valve repair is now a life restoring procedure for patients with leaky valves, particularly for the aortic valves.
Now, reproducible techniques for valve repair and devices to stabilize and restore the shape of the aortic valve has allowed many patients to live without the need for an artificial one. Moreover, the approach for valve surgery becomes less and less invasive with minimally invasive techniques as well as transcatheter therapies. The opportunity to innovate is the reason that I focus on valve disease in my practice.
Adam Pick: Dr. Malaisrie, how have all these new medical advances change the way that you are able to treat defective valves with smaller incisions?
Dr. Chris Malaisrie: Technology has allowed us to innovate in cardiac surgery. Where previously patients had to have a full sternotomy scar, which is about an eight to nine-inch incision sometimes down the middle of the chest, we often need to do minimally invasive cardiac surgery through keyhole incisions. Just to put some light on some new devices, several devices have made minimally invasive cardiac surgery safer and reproducible.
These include new generation tissue valves, also called sutureless or rapid deployment valves, which would be placed with as little as three sutures. In addition, auto-knotting devices, which secure stitches without the need to hand tie greatly facilitate a valve implantation for the cardiac surgeon. I think the most transformative device is the TAVR procedure with transcatheter heart valves. These valves can be delivered on a thin tube through the groin without the need for open heart surgery. These technologic advances have made the approached cardiac surgery a lot less invasive.
Adam Pick: Dr. Malaisrie, can you talk about the patient benefits of these new, minimally invasive approaches?
Dr. Chris Malaisrie: A minimally invasive cardiac surgery and transcatheter heart valve is associated with an accelerated recovery. In particular, patients don’t need to adhere to exercise restrictions that are often associated with a typical sternotomy incision. This means that patients can be discharged as early as three days after open heart surgery. and as little as one day after a transcatheter valve procedure and return to full activity after just two weeks.
Adam Pick: Dr. Malaisrie, how have transcatheter devices changed your thinking specific to the long-term management of valvular disease for patients specific to their valve selection.
Dr. Chris Malaisrie: Now, TAVR or transcatheter valve replacement has emerged as the preferred choice for elderly and otherwise high-risk patients with aortic valve disease. What some people don’t know is that TAVR has now become the preferred treatment for patients who previously had an open valve replacement with a tissue valve, but now has seen that tissue valve degenerate over time. This is otherwise called the valve-in-valve procedure because it entails placing a brand new transcatheter heart valve within the previous tissue valve, which is now failing. The TAVR valve-in-valve procedure I think is an excellent choice for our patients who previously had a tissue valve replacement who now need that valve replaced.
Adam Pick: Dr. Malaisrie, what exactly is a valve-in-valve procedure?
Dr. Chris Malaisrie: The valve-in-valve procedure resembles the TAVR procedure in that it involves a valve, which is loaded on a small, plastic catheter that is delivered through the groin without open heart surgery. The valve-in-valve procedure is meant to be placed within an old tissue valve, in particular either the aortic, mitral, tricuspid, or pulmonary position. The most common valve that is affected is the aortic valve. That’s probably the number one procedure that we perform the valve-in-valve procedure for.
Adam Pick: Are these valve-in-valve procedures performed regularly at a leading cardiac center like Northwestern?
Dr. Chris Malaisrie: The valve-in-valve procedure can be performed in the aortic, mitral, pulmonary, and tricuspid position. It is the preferred treatment choice at our center at Northwest Memorial Hospital for patients who previously had a valve replacement in the aortic and mitral position. We see these patients regularly, and for those with a degenerating tissue valve and appropriate anatomy as evaluated by a CT scan, the valve-in-valve procedure is our preferred treatment choice. Not all patients can get the valve-in-valve procedure, and we should keep these in mind. These include patients who previously had a mechanical valve, or patients who have now an infected valve, or patients who have a leakage around the valve itself. These are patients that would be excluded from the valve-in-valve procedure.
Adam Pick: Dr. Malaisrie, I’m sure patients want to know how other patients are doing after they have a valve-in-valve procedure. Can you maybe share some of your surgical outcomes after these valve-in-valve procedures are performed?
Dr. Chris Malaisrie: The valve-in-valve procedure has led to a much-reduced recovery time. Most of our patients get discharged the next day. The procedure, itself, can be done not only without open heart surgery or 0:07:25 bypass. We do these procedures without general anesthesia, otherwise known as twilight medication. The patient is awake, sedated, but awake. I think that greatly facilitates discharge to home. Patients can expect a return to full activity within two weeks.
Adam Pick: It’s amazing what you and your team are doing over there with the transcatheter technology and now the valve-in-valve technology. I guess I’ve just got to ask you this question. What else should patients know about valve-in-valve procedures?
Dr. Chris Malaisrie: The valve-in-valve procedure is currently FDA approved for patients with failing tissue valves who are considered high risk for open heart surgery. For those patients who are at lower risks for repeat open heart surgery, trials have recently completed for aortic valve-in-valve but are still underway for patients with failing mitral valves. These trials seek to demonstrate the safety and efficacy of TAVR for this patient group. We are an investigator in the Partner 3 valve-in-valve Trial. Our group will be presenting data on the low risk patients undergoing aortic valve-in-valve later this year and really excited to see those results.
Adam Pick: Dr. Malaisrie, I’m sure that patients are wondering what might be your best piece of advice for those folks who might have a tissue valve that’s failing and are considering a valve-in-valve procedure?
Dr. Chris Malaisrie: I think patients should consult their cardiologist and cardiac surgeon who previously did their operation, but also get tested to see if they’re anatomically suitable for the valve-in-valve procedure. What’s most important is to find a Center that can both offer a valve-in-valve procedure, which is FDA approved and commercially available, but also offer innovative new devices, which can be offered under a clinical trial.
Adam Pick: Dr. Malaisrie, on behalf of all the patients with heart valve disease, I’d like to thank you and the entire team at Northwestern Medicine for your ongoing pursuit of healthy heart valves through new technologies, new advances, and new techniques like valve-in-valve procedures. As we always say here, keep on ticking.
Dr. Chris Malaisrie: Thank you very much, Adam.