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 Valvuloplasty for Mitral Stenosis
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.
Percutaneous 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, as patients must be carefully screened and selected to ensure the procedure is appropriate for them to achieve satisfactory results.
A Mitral Repair Option for High-Surgical Risk Patients
Mitral regurgitation is a common heart disorder that causes blood to leak backwards through a normally one-way valve. Surgery is the gold standard for treating it, but now there could be a viable option for patients who are not candidates for surgery.
An ongoing clinical trial is studying the effectiveness of a new device called MitraClip, which essentially tethers the flapping mitral valve leaflets together to reduce the leak and improve forward blood flow. It is implanted during a percutaneous procedure using a catheter and balloon rather than requiring an open-heart operation
Mitral Valve Clip
Percutaneous Valve Repair System
Images used with permission from Abbott Vascular, Inc.
MitraClip is a viable alternative for patients who are too high-risk to undergo surgery, says Dr. Patrick Whitlow, Cleveland Clinic, lead author of the EVEREST II trial with MitraClip. While surgery is still superior in patients who have a low-surgical risk, results from the study suggest reduced mitral leak and improvement in clinical symptoms occur after successful clip implantation in the inoperable patient group.
“We know it is not as effective as surgery,” Dr. Whitlow says, noting that the MitraClip device reduces but does not stop regurgitation—that’s the blood flow back through the mitral valve into the heart. “[MitraClip] can reduce regurgitation to 2+ or less but not to 1+ or less. But even if it just reduces the leak by one grade, this still seems to be associated with improvements in the size and shape of the left ventricle, or pumping chamber of the heart – and an improvement in symptoms compared to medically-treated patients that cannot have surgery..”
The MitraClip is not yet approved for use in the United States, but there are several research trials going on to further evaluate the device. Cleveland Clinic is a leader in this new technology.