Transcatheter Aortic Valve Replacement (TAVR)
A) Balloon catheter in the diseased valve; B) Balloon with valve in place; C) Balloon inflation to secure the valve
Also called transcatheter aortic valve implantation (TAVI)
Transcatheter aortic valve replacement (TAVR) is a procedure for select patients with severe symptomatic aortic stenosis (narrowing of the aortic valve opening) who are not candidates for traditional open chest surgery or are high-risk operable candidates. TAVR is performed on a beating heart and does not require cardio-pulmonary bypass.
The TAVR valve is made of bovine (cow) pericardium and is supported with a metal stent.
Transcatheter valve in place
Transcatheter valve inflation
There are currently three approaches:
A catheter is placed in the femoral artery (in the groin) similar to angioplasty, and guided into the chambers of the heart. A compressed tissue heart valve is placed on the balloon catheter and is positioned directly inside the diseased aortic valve. Once in position, the balloon is inflated to secure the valve in place.
This procedure is performed with general anesthesia in a hybrid suite (which has both catheterization and surgical capabilities). A team of interventional cardiologists and imaging specialists, heart surgeons and cardiac anesthesiologists work together, utilizing fluoroscopy and echocardiography to guide the valve to the site of the patient’s diseased heart valve.
Cleveland Clinic was one of three early pioneering centers in the USA and one of more than 20 centers involved in the randomized PARTNER trials (Placement of Aortic Transcatheter Valve) of TAVR. The one-year results of the PARTNER-B trial were released in September 2010. The inoperable patients involved in the PARTNER-B trial had severe symptomatic aortic stenosis and were not candidates for surgery. The patients were randomly selected to receive either TAVR or standard medical care. Among the inoperable patients who had TAVR, the procedure reduced their absolute risk of dying within a year by 20% (the risk of mortality at one year went from 50% to 30%).
The transfemoral approach is now approved by the FDA for patients who have severe, symptomatic aortic stenosis who are ineligible for open surgical replacement, based on the PARTNER-B trial results. It is not approved for patients who are eligible for traditional aortic valve surgery, patients with bicuspid aortic valves, endocarditis, or cannot tolerate anticoagulation/antiplatelet therapy.
Investigational Transfemoral Approach
TAVR via femoral artery is now being tested for moderately high risk and high risk operable patients as well as inoperable patients in a new research trial PARTNER-II.
The transfemoral approach requires the use of catheters large enough to place the transcatheter aortic valve replacement through. Patients with peripheral artery disease may not have arteries large enough to support the transfemoral approach. In this case, patients can be evaluated to participate in a research study (PARTNER-II) which uses the alternative transapical approach.
During the transapical procedure, the surgeon makes a 4 inch incision between the ribs. A compressed tissue heart valve is placed on the balloon catheter, inserted through the ribs into the apex of the left ventricle and positioned directly inside the diseased aortic valve. Once in position, the balloon is inflated to secure the valve in place.
This procedure is performed under general anesthesia, in a hybrid operating room. A team of imaging and interventional cardiologists and heart surgeons work together, utilizing fluoroscopy and echocardiography to guide the valve to the site of the patient’s diseased heart valve.
Investigational Transaortic Approach
During the transaortic procedure, the surgeon makes a J shaped incision at the top of the sternum in between the manubrium and the sternum.
A compressed tissue heart valve is placed on the balloon catheter, inserted into the aorta and positioned directly inside the diseased aortic valve. Once in position, the balloon is inflated to secure the valve in place.
What you should know about TAVR
- TAVR is performed in high-risk and inoperable patients with aortic stenosis. All patients are carefully evaluated to see if they are candidates for traditional surgical aortic valve replacement and then TAVR can be considered for treatment. The goal is to provide the best treatment for each individual patient.
- Cleveland Clinic was involved in TAVR research since 2006 and has evaluated around 2000 patients and performed more than 220 procedures
- Transfemoral TAVR was recently approved by the FDA for inoperable patients.
- There are ongoing research trials for TAVR for high-risk operable, moderate risk operable and inoperable patients.
- The positive results seen in the PARTNER trial were related to procedures performed at valve centers where there is a team approach between interventional cardiologists and surgeons.
- The one year survival results for PARTNER-A, the high-risk patient population were similar in those who received surgery vs. those who received TAVR.
- There are still risks associated with TAVR as there is with surgical AVR. These should be taken into consideration in decision making.
Please contact us if you would like to be evaluated for TAVR.
- Smith CR, Leon MB, et. al. Transcatheter versus Surgical Aortic-Valve Replacement in High-Risk Patients, N Engl J Med 2011; 364:2187-2198, (see video in article)
- Leon, MB, Smith CR, et al. Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery, N Engl J Med 2010; 363:1597-1607October 21, 2010
- Svensson, LG, Dewey T, et al. United States Feasibility Study of Transcatheter Insertion of a Stented Aortic Valve by the Left Ventricular Apex, Ann Thorac Surg 2008;86:46-55.
- First TAVR with FDA nod, www.thebeatingedge.org, 11/2011
- FDA approves first artificial aortic heart valve placed without open-heart surgery, FDA, 11/2011
- Questions and answers about percutaneous transcatheter aortic valve replacement can be found at our previous web chat transcripts.
- ClinicalTrials.gov PARTNER trial information
TAVR Team: Drs. Svensson, Roselli, Kapadia, and Tuzcu with Dr. Sale, R. Schroder RNFA, S. Godley RN, R. Mitchell CST, J. Horfath RN, Dr. Canale, N. Sharaba ST, K Bitner RT, R Cox RN, J Howerton CRNA, and Dr. Kumar
"This effort has been an unprecedented collaboration between cardiologists and surgeons. It also involved critical contributions from imagers, anesthesiologists, critical care experts, nurse technicians, OR technicians and others – coming together as a single team to save lives."Dr. E. Murat Tuzcu
Percutaneous Mitral Valve Interventions
Mitral Regurgitation (Leaky valve)
Mitral regurgitation (MR) is a common heart disorder that causes blood to leak backwards through the heart’s mitral valve. There are two types of MR ─ degenerative and functional.
Degenerative MR – Commonly called mitral valve prolapse or myxomatous mitral valve disease. The leaflet(s) (the flaps inside the valve that open and close to let blood flow through) and chordae (tough, fibrous strings attached to the leaflets) become stretchy. The leaflets become floppy and they do not close tightly. When this happens, surgery is the best treatment option. However, surgery is too risky for some patients. A new treatment option, called the MitraClip, was recently approved by the FDA to treat these high-risk patients.
Functional MR – The mitral valve leaks due a secondary cause such as dilatation (widening) of the annulus (a ring attached to the leaflets) or damage to the papillary muscles or chordae that support the leaflets. This damage can be caused by changes in how well the left ventricle works as a result of a heart attack or cardiomyopathy. The left ventricle is the bottom left chamber of the heart that does the majority of pumping. If you have functional MR, your valve leaflets may be normal. Many patients with functional MR also develop heart failure.
Although it has been shown that surgery is the best treatment for patients with degenerative MR, there isn’t the same type of recommendation for patients with functional MR. The American College of Cardiology (ACC), American Heart Association (AHA), Heart Failure, and Society of Thoracic Surgeons (STS) treatment guidelines consider surgery as a treatment option but do not recommend it for all patients.
A new study is designed to study how well the MitraClip works compared with medical therapy to treat patients who have heart failure with functional MR and who are extremely high-risk for surgery. The study is called the COAPT trial. Cleveland Clinic will be taking part in this study.
Treatment with the MitraClip
To see if you are a possible candidate for treatment with the MitraClip, you’ll have a comprehensive evaluation (based on ACC and STS guidelines) by a multidisciplinary team. The evaluation focuses on your condition, current management, and quality of life.
Cleveland Clinic’s Interventional Mitral Valve physician team
- Heart failure (Drs. Jacob, Taylor, Starling)
- Interventional cardiology (Drs. Kapadia, Tuzcu, Krishnaswamy)
- Cardiac Surgery (Drs. Mick, Gillinov, Smedira)
You will have a transthoracic echo (TTE) and transesophageal echo (TEE) to determine if treatment with the MitraClip is possible and to check for MR. The testing is also used to see if your leaflets are normal, if the leak or jet is central (not broad), and to evaluate how well your left ventricle is working.
The team will evaluate how well your condition has been managed with medications or devices (biventricular pacing). They will determine whether you need other surgical interventions, if surgery is right for you, and if you would benefit from treatment with the MitraClip.
Mitral Valve Clip
Percutaneous Valve Repair System
Images used with permission from Abbott Vascular, Inc.
Preparation for treatment with the MitraClip starts a day or two before the procedure. You will come to Cleveland Clinic to meet your team (nurse practitioners, surgeon, cardiologist, and anesthesiologist) and learn about what to expect.
You will receive a detailed explanation at the hospital, but here are some general notes:
- The procedure is done under general anesthesia.
- The actual procedure takes about 2 to 4 hours. Preparation and recovery require additional time.
- The MitraClip is inserted using a catheter (a thin tube that is inserted through a small incision in your groin).
- The catheter with the MitraClip attached is threaded through the femoral vein to the mitral valve.
- The clip is put into place and the catheter is removed.
- The clip stays in the heart to allow the valve to close tightly.
- You will stay in the hospital for about 4 days after the procedure.
- You should be able to go back to your normal routine in about 2 weeks.
- You will see your doctor for three follow-up visits: 30 days after the procedure, 6 months after the procedure and one year after the procedure.
Mitral Stenosis (Narrowed Valve)
Balloon Mitral Valvuloplasty is used to treat patients with mitral valve and pulmonic valve stenosis (narrowing of the valve). The procedure can also be used to treat stenosis of the aortic valve; however, this treatment is not as widely used. All patients must be carefully screened and selected to make sure the procedure will provide satisfactory results.
During mitral valvuloplasty, a catheter is placed in the femoral vein (in the groin) and guided into the chambers of the heart. The cardiologist then creates a tiny hole in the wall between the heart’s two upper chambers (atria). This hole provides an opening for the cardiologist to access the left atrium using a special catheter that has a balloon at the tip.
The catheter is positioned so the balloon tip is directly inside the narrowed mitral valve. The valve opening is widened (dilated) by rapidly inflating and deflating the balloon. Once the cardiologist has determined that the opening has been widened sufficiently, the balloon is deflated and removed.
The procedure is similar when performed to treat aortic and pulmonic valve stenosis.