Transcatheter Mitral Valve Repair: Nursing Considerations from a U.K. Hospital

Sally Madden’s “An alternative treatment approach to mitral regurgitation” appeared in the November 2011 issue of Nursing Standard.¹ Ms. Madden discusses transcatheter mitral valve repair and her experiences in taking care of these patients.

The MitraClip (Abbott Vascular) received CE Mark approval in 2008. It is not yet approved for use in the United States.

Tell us about your background and current position.

I have been a registered nurse for approximately 28 years. Following my nurse training in England, I worked on a medical ward and then the I.C.U. I was fortunate enough to work in the United States in the late 1980’s to the early 1990’s at a critical care unit in Florida before returning to England, where I worked as a recruitment manager, recruiting for a number of U.S. hospitals, from California down to Florida and across the U.S.

I joined the University Hospital of South Manchester, which is approximately a 900-bed facility, about 20 years ago, and have been working in cardiology or nursing quality ever since. The majority of my time has been spent in cardiology, and as part of my masters, I focused on cardiac valve treatments. I have spent three to four years looking at patient care quality across the hospital site while project managing improvement initiatives. The University Hospital of South Manchester is a large teaching hospital; one of its specialties is in the field of cardiac intervention and heart surgery, in addition to a very successful heart and lung transplant program.

Your hospital participated in a clinical trial for the MitraClip mitral valve repair system (Abbott Vascular) for mitral valve regurgitation.

Yes, our first mitral valve procedure was done in May 2010.

What is mitral valve regurgitation?

The mitral valve lies between the left atrium and the left ventricle, and its purpose is to support one-directional blood flow through the heart. A healthy functional valve will open just before and during atrial contraction, allow passive filling of the left ventricle with blood from the left atrium, and then close tightly during ventricular systole. This prevents blood from flowing backwards into the left atrium during ventricular contraction.

Mitral regurgitation occurs when the valve doesn’t completely close together during ventricular contraction, and a portion of the blood in the left ventricle is propelled back through the leaflets of the mitral valve into the left atrium. This reverse blood flow is known as a regurgitant jet and is graded according to its severity. It can occur as a result of valve degeneration, or be functional, where the valve itself appears normal in structure, but due to other changes in the heart’s structure such as a dilated left ventricle or a dilated mitral annulus, or even papilliary muscle displacement, the valve fails to close properly.

How are mitral regurgitation patients identified?

Initially, mitral regurgitation can be well tolerated, if the left ventricular function is preserved, so it can go undiagnosed for some years. However, once the left ventricle and atrium are involved, mitral regurgitation can give rise to symptoms of heart failure such as dyspnea, lethargy and fluid retention. Cardiac arrhythmias such as atrial fibrillation and chest discomfort may also result.

Mitral regurgitation may be discovered by chance, during a medical examination. On oscillation, the intensity and duration of systolic murmur, and the presence of a third heart sound, which is often heard loudest at the apex and radiates to the left lateral axilla, may be heard. The presence of a third heart sound can trigger further investigations of the patient, such as an echocardiogram.

How does the MitraClip help with mitral regurgitation?

When the leaflets of the mitral valve don’t fully close and a small orifice remains across the valve during ventricular systole, this allows a regurgitant jet to pass through into the left atrium. The MitraClip clips the portion of the mitral valve which is failing to close tightly together, so that during systole it reduces the level of mitral regurgitation from perhaps a grade of three or four, to a grade of one or two.

Trials have included EVEREST, EVEREST II, and a high-risk registry. Currently ongoing are ACCESS-Europe and REALISM in the United States. At the moment, our facility is not actually part of the ACCESS-Europe, but we do perform other transcatheter valve implants. The REALISM study follows EVEREST II in the U.S., which is enlisting similar patients to those in ACCESS-Europe. It is comparing the MitraClip against medical management and mitral valve surgery, and is a postmark observational study of two phases. Phase I looks at the MitraClip, medical management and mitral valve surgery in heart failure patients with functional mitral regurgitation. Phase II takes a closer look at the MitraClip, looking at core lab values and echo values after 12 months. I believe the primary data is due in December 2012, but the actual trial end is December 2013.

Tell us about starting transcatheter mitral valve repair at the University Hospital of South Manchester.

Obviously, there is a steep learning curve for everyone involved when you take on a new procedure at any facility. The MitraClip procedure involved a diverse group of people with specialist knowledge in interventional cardiology, echocardiography and cath lab skills. These are the key interventions required to carry out the procedure in the lab. The team supported the whole patient journey by producing detailed, written guidance around pre- and post-op nursing, and medical care. The patients and the families were supported and prepared throughout the selection process by medical and nursing consultations, and patient information leaflets. Patients are nursed in critical care areas, and looked after by registered nurses following the procedure. It does require quite a lot of groundwork and prep before the procedure goes ahead.

Where did the MitraClip procedure take place?

In the cath lab at the hospital, which is actually adjacent to the cardiac operating rooms and intensive care units. We had a full complement of cath lab staff: nursing, radiographers, technologists and anesthetists, and they worked alongside three cardiologists with great expertise in interventional cardiology and echocardiography, with particular attention to the three-dimensional imaging. Truly a multi-disciplinary effort.

Tables 1-2 show some of the post procedure nursing care considerations for MitraClip patients.

Creating these documents was quite time-consuming, because obviously it was a new procedure. There was very limited data at the time we started to do the MitraClip procedure at University Hospital South Manchester. We identified that the possible complications or risks, and discomforts were those associated with percutaneous implantations and in-heart valve surgeries. We took a close look at how we should monitor these patients, as we wanted to develop an overall package to support the procedure, one that incorporated pre-op and post-op guidance. We developed patient information leaflets, which relatives and patients could utilize to aid them in making informed decisions during the critical time of making important treatment choices. We also wanted to make sure that nursing and medical staff members were fully supported in providing safe, quality care for these patients on their journey.

For the first case, as the nurse that led the development of these documents, I was fortunate to be included in the complete patient journey. I escorted the patients to the cath lab, remained in the cath lab to watch the procedure live, and then went with the patient into the critical care area to support those nurses immediately post procedure, just to talk them through and help them re-familiarize themselves with all the paperwork and the after care that these patients were going to require. I made myself available most of the day for that first procedure, because even though people had read about the MitraClip, and had information in the clinical areas about the MitraClip, we felt that the nursing staff and junior doctors involved in the first live case should be supported, in addition to providing support for the patient and family members.

What are some of the immediate post procedure nursing concerns?

Generally, the same possible risks and discomfort that can occur in association with percutaneous implantations and heart valve surgery. These may include device failure, thrombus on the clip or clip detachment. We also identified heart attack or abnormal heartbeat, impaired blood clotting, stroke or mini-stroke, post implantation bleeding, bruising, pain at the puncture site, and damage to the femoral vein, which is used to introduce the MitraClip. Heart infection, cardiac tamponade, heart failure, and allergic reaction to anesthetic or medications would be the main points for facilities to note when they take on this procedure. That list isn’t exhaustive, however; much of the literature will show the real terms of risk following the procedure.

What is the importance of transesophageal echocardiography (TEE) during the procedure?

With fluoro, only the tip of the catheters can be visualized, so the TEE is critical, as it allows visualization of the heart’s structures and functions, allowing the cardiologist to guide clip placement, and provides real-time and motion images for the interventionalist. It is used throughout the procedure until the clip is locked into place, in order to make sure that there is optimal clipping of the failing portion of the valve, reducing the mitral regurgitation to the minimum amount. The first one I watched onscreen was absolutely amazing.

Is TEE also used post procedure?

Yes, it is, again, critical. Following the procedure, once the patient is back in the clinical area, the physician then performs another echo to check for any pericardial effusions, tamponade, and to see how the mitral valve is working with the newly positioned clip in place.

Any recommendations for facilities who one day might be implementing this procedure?

It is a challenging and skilled specialist procedure where expertise in echocardiography and interventional cardiology are required to deliver the clip. It does require a truly multi-disciplinary approach to support all aspects of the patient journey. The complete patient journey needs to be evaluated and provided for, from the critical patient evaluation and selection, pre procedure care, clip delivery in the cath lab, and post procedure care and follow up. All aspects of nursing and medical care need to be addressed and prepared for ahead of the first case, so staff can confidently support quality care and patient safety.

Would you say that the transcatheter mitral valve repair procedure is as equally complex as transcatheter aortic valve replacement (TAVR)?

They are equally complex procedures. They do have different potential complications that can occur post procedure, but once again, there are trials and registries that would give a truer picture of what the complications have actually been. However, because there are some similarities, our facility found the MitraClip procedure easier to adopt as it had already run a successful TAVR program.

It is such an exciting time for cardiology. I can remember what a big deal it was to put in an ICD in the early 1990’s. I am watching the development of percutaneous and transthoracic delivery with close interest.

Figure 1.  The Abbott MitraClip.

Figure 2. Pre-MitraClip Procedure: The MitraClip device being positioned in the heart during the procedure. The blue color represents the mitral regurgitation or MR.

Figure 3. During MitraClip Procedure: During the MitraClip procedure, the mitral valve leaflets are clipped together to reduce mitral regurgitation.

Figure 4. Post-MitraClip Procedure: After the procedure, the MitraClip device is designed to remain and move with the heart, allowing blood to flow through each opening.

Sally Madden can be contacted at Sally.Madden@uhsm.nhs.uk or ladymadden1@gmail.com 

Reference

1. Madden S. An alternative treatment approach to mitral regurgitation. Nurs Stand 2011 Nov 30-Dec 6;26(13):40-46.