Have you been diagnosed with Aortic valve stenosis and experiencing severe symptoms such as:
- Shortness of breath
- Fatigue
- Swelling in your legs
- Dizziness
- Chest pain
- Passing out
- An unpleasant awareness of your heartbeat
- Fainting episodes
If yes, your heart doctor might have advised a Transcatheter Aortic Valve Replacement (TAVR) procedure for you instead of an open heart surgery (OHS).
Or, you might be having another health condition, such as kidney or lung disease or diabetes, which would make open-heart valve replacement surgery risky for you. In this case as well, your doctor might advise Transcatheter Aortic Valve Replacement (TAVR) for your aortic stenosis.
Our review of available scientific research on the safety and efficacy of the various options leads us to conclude that patients recommended for aortic valve replacement should seek consultation with a surgeon or cardiologist who utilizes the Sapien 3 line of prosthetic aortic valves.
Sapien 3 has equivalent or superior outcomes compared with other contemporary TAVR valves used to treat aortic stenosis in patients at high surgical risk. This is according to meta-analyses of many randomized controlled trials (RCTs) and large nonrandomized research studies. Furthermore, other high quality research studies suggest Sapien 3 is a safer alternative to Open Surgical Aortic Valve Replacement in patients at low surgical risk.1,2,3
We’re here to help you have a more informed conversation with your doctor about the right Aortic Valve Replacement for you.
What is Minimally Invasive Aortic valve replacement?
A minimally invasive aortic valve replacement is a surgery to replace a poorly working aortic valve with an artificial valve. The aortic valve is one of the heart’s 4 valves. The valves help blood flow through the heart’s 4 chambers and out to your body normally. The surgery is called “minimally invasive” because it uses a smaller incision than a traditional open repair. This may lead to easier and faster recovery from surgery.
Quick Reviewer
Below is a quick review of the main factors used in comparing the various valve systems.
| Valve Options for TAVR | Sapien 3 & Sapien 3 Ultra | Sapien XT | CoreValve | Evolut R | Evolut Pro | Evolut Pro+ | Portico | Acurate neo & Acurate neo2 | ||
|---|---|---|---|---|---|---|---|---|---|---|
| Age Group | 65-80 years | 65-80 years | 65-80 years | 65-80 years | 65-80 years | 65-80 years | 65-80 years | 65-80 years | ||
| FDA Approval | Yes | Yes | Yes | Yes | Yes | Yes | Yes | No for Acurate neo2 | ||
| Risk of Bleeding, Stroke, PVL & Death | Less than OHS | More than Sapien 3 & Sapien 3 Ultra | More than Sapien 3 valves | Overall: less PVL: Less than Sapien 3 | Less than Evolut R | PVL: less Bleeding & Stroke: More | Similar to other valves | Neo: More Neo2:less | ||
| Need for Pacemaker Implantation | Less than other valves in the market | Less than Sapien 3 & Sapien 3 Ultra | More than Sapien Valves | More than Sapien Valves | Less than Evolut R | Less | Similar to other valves | Less |
TAVR is the latest advancement in the treatment options for aortic stenosis. Aortic valve stenosis is a heart disease in which the aortic valve of the heart thickens (calcifies) with age and becomes narrow. This leads to decreased blood flow from the heart, through to the aortic valve, and into the rest of the body.
Normally, the aortic valve keeps blood flowing out of your heart and into your aorta (the main artery in your body) without blood flowing backward into your heart.
In the developed world, aortic stenosis is the most prevalent form of valvular heart disease. It is strongly age-related, with a prevalence of only 0.2% among people in their 50s but 9.8% among people in their 80s.
Why is TAVR Preferred Over Open Heart Surgery (OHS)?
Now to the main part! Aortic valve stenosis is a mechanical impairment in the functioning of the aortic valve. This means it cannot be managed by medications alone and requires an interventional procedure to fix or replace the valve.
For a long time, open-heart surgery (OHS) for the replacement of an aortic valve with a mechanical artificial valve has been the treatment of choice in patients both over and under 65 years of age. It is a highly invasive and risky procedure associated with increased complications and requires longer hospital stays and regular follow-up checkups.
With time, there has been a need for an alternative option for older patients (>65 years) who have severe aortic stenosis exhibiting signs and symptoms or those who are at high risk of complications from Surgical Aortic Valve Replacement (SAVR) due to advancing age, an underlying health condition, or suppressed immune system. And this is where transcatheter aortic valve replacement (TAVR) comes in!
Although TAVR is now the treatment of choice for high-risk patients in the older age group, studies are still underway to employ this procedure, as a first-line treatment option, for patients younger than 65 years of age. If you would like us to alert you when TAVR receives approval for patients under age 65, sign up here.
What Exactly Happens During a TAVR Procedure?
TAVR has revolutionized the treatment for aortic stenosis so more and more patients in the older age group are benefiting from it.
It is a minimally invasive procedure, requiring sedation as opposed to general anesthesia, in which a flexible tube (catheter) loaded with the prosthetic valve, made from cow or pig heart tissue, is inserted into a blood vessel in your groin or chest area and guided to your heart through repetitive X-ray images or echocardiogram. Once it reaches the location of your natural aortic valve, the new valve is positioned there correctly and is fixed into place.
The best part? For TAVR, there are a variety of options for bioprosthetic heart valves available in the market! And we are here to give you a comparison of such options so that when you visit your doctor, you can make an informed decision regarding the valve option that you would want to go for.
So, let’s begin!
What are Your Options for Transcatheter Heart Valve Systems
There are different FDA-approved market options for transcatheter heart valves. But before diving deep into each of them, it’s important to know when are these valves indicated for use and in which patients should these not be used.
Who are the transcatheter heart valves indicated for?
These valves are indicated for patients who:
- Have severe aortic stenosis due to age-related calcification of the aortic valve and exhibit signs and symptoms of the disease
- Are at high risk of complications from OHS due to other health conditions or advancing age
- Experience failure of a previous surgical bioprosthetic valve
When should the transcatheter heart valves not be used?
- The transcatheter heart valves are not indicated for patients who:
- Are allergic to the material of the prosthetic valve—for example, Nitinol (titanium or nickel) in the case of the CoreValve series
- Cannot tolerate blood-thinning medications
- Have an active infection of the heart, like active bacterial endocarditis, or other active infections
Transcatheter Heart Valves for TAVR
Now, let’s look at some details of each individual transcatheter heart valve for TAVR.
Sapien 3 (third generation) valve
Paravalvular regurgitation
Paravalvular regurgitation or paravalvular leak is a common complication seen in heart valve transplantation procedures. It occurs due to a space left between the natural heart tissue and the new artificial valve. As a result, blood flows back into the heart chamber during pumping or there is turbulent blood flow.
Systematic reviews have also documented lower rates of bleeding, stroke, and death with Sapien 3 as compared to OHS.
The correct sizing and placement of the Sapien 3 valve are essential because once deployed, the valve cannot be repositioned. A surgeon who is very experienced with this particular valve is critical.
Sapien 3 Ultra valve
It shows the same success rates as Sapien 3 but is associated with a reduced incidence of paravalvular regurgitation.
Sapien XT (second generation) valve
It has exhibited lower incidences of pacemaker implantation as compared to the third-generation Sapien 3 valve.
Sapien XT valve is associated with higher rates of stroke, vascular complications, and paravalvular regurgitation.
CoreValve series
CoreValve
CoreValve was the first-generation self-expandable valve introduced by Medtronic.
Although self-expandable valves allow for correct placement and easier repositioning as compared to balloon-expandable valves, the CoreValve has been associated with increased incidence of paravalvular regurgitation, bleeding complications, and stroke.
Evolut R
Unlike the Sapien series, Evolut R can be repositioned after the TAVR procedure and is associated with fewer vascular complications like bleeding, stroke, etc. Multiple systematic reviews have documented decreased incidences of paravalvular regurgitation with Evolut R than with Sapien 3 valve.
The use of Evolut R valve for TAVR has shown an increased rate of permanent pacemaker installation in the long term.
Evolut Pro
Evolut R has been succeeded by Evolut Pro.
Some studies have shown that Evolut Pro valves offer significant improvement against paravalvular leak and higher rates of pacemaker implantation seen with Evolut R valves. However, more large-scale studies are still needed to confirm this.
Evolut Pro+
Evolut Pro+ is a further improvement in the self-expandable CoreValve Series.
It is associated with fewer pacemaker installations and less paravalvular leaks.
There is increased risk of vascular complications such as bleeding and stroke with Evolut Pro+ valve.
Portico valve
The FDA-approved Portico valve by Abbott is a self-expandable valve that is implanted using the Abbott’s FlexNav delivery system. The sleek design of the delivery system caters to patients with different structural sizes of their aortic valves and small vessels. Its flexibility allows it to work through the calcified valves and vessels easily. This delivery system also ensures precise placement of the Portico valve during TAVR.
The advantages of using Portico valves, especially the decreased risk of developing stroke after the TAVR procedure, are similar to those seen with other transcatheter aortic valves. However, in long-term follow-up, patients implanted with Portico valve show improved heart health and physical strength and mobility.
Accurate neo2 valve
The Boston Scientific Acurate neo2 is a modified version of the self-expandable Acurate neo valve. It has received the Conformite Europeenne (CE) Mark but has not yet been approved for sale in the USA by FDA.
The first-generation Acurate neo has been associated with increased incidences of stroke, paravalvular regurgitation, and kidney injury. Therefore, the Acurate neo2 has been developed to address all these issues and it has delivered excellent results in clinical trials. However, if you are residing in the USA, you will have to wait for some time before you can opt for this valve!
Frequently Asked Questions
Can an aortic valve be replaced with minimally invasive surgery?
A minimally invasive aortic valve replacement is a surgery to replace a poorly working aortic valve with an artificial valve without the need for open heart surgery. The surgery is called minimally invasive because it uses a smaller cut (incision) than a traditional open repair.
What is the success rate of minimally invasive aortic valve replacement?
In the NIHR study, bioprosthetic valves appeared safe, and they were linked to average lifespans when matched to the population having surgery. Ten years after replacement, the great majority of people (94%) had a functioning valve. After 20 years, more valves had failed, with 48% of valves deteriorating.
What is the recovery time for minimally invasive aortic valve replacement?
Most heart procedures – even those that are called minimally invasive – require that the patient be under anesthesia for four to six hours and for the surgeon to cut through part or all of the patient’s breastbone. The recovery time after these surgeries is six to eight weeks to allow the bone to heal.
How long is hospital stay after minimally invasive heart surgery?
Once you are able, your care team will encourage you to move around as much as possible during your hospital stay. Most patients can expect a two to five-day hospital stay following minimally invasive heart surgery.
What is the average age for aortic valve replacement?
Average patient age was 53 to 92 years.
What can We Conclude From This?
There are many different FDA-approved transcatheter aortic valves available in the market for your TAVR procedure. Now that you have a general idea of these options, we hope you will be able to make a more informed decision together with your doctor.
To sum it up, no one valve is right for every patient, but the clinical studies suggest that the Sapien 3 series of valves has the most favorable profile at the time of this posting.
Selected References
- Boskovski MT, Gleason TG. Current therapeutic options in aortic stenosis. Circ Res. 2021;128(9):1398-1417. doi:10.1161/CIRCRESAHA.121.318040
- Medtronic. Transcatheter aortic heart valves – indications, safety, warnings. Medtronic.com. Accessed May 19, 2022. https://www.medtronic.com/us-en/healthcare-professionals/products/cardiovascular/transcatheter-aortic-heart-valves/indications-safety-and-warnings.html
- Yasgur BS, MA, LMSW. Transcatheter aortic valve replacement: Current and emerging approaches. The Cardiology Advisor. Published December 14, 2015. Accessed May 19, 2022. https://www.thecardiologyadvisor.com/home/topics/heart-failure/transcatheter-aortic-valve-replacement-current-and-emerging-approaches/2/
- Htun NM, Webb JG. Evaluation of the Edwards SAPIEN 3 transcatheter valve for aortic stenosis. Expert Rev Med Devices. 2016;13(3):225-232. doi:10.1586/17434440.2016.1149288
- Nazif TM, Cahill TJ, Daniels D, et al. Real-world experience with the SAPIEN 3 ultra transcatheter heart valve: A propensity-matched analysis from the United States. Circ Cardiovasc Interv. 2021;14(9):e010543. doi:10.1161/CIRCINTERVENTIONS.121.010543
- Alperi, A, Faroux, L, Muntané-Carol, G, and Rodés-Cabau, J. Meta-analysis Comparing Early Outcomes Following Transcatheter Aortic Valve Implantation With the Evolut Versus Sapien 3 Valves. Am J Cardiol. 2021;139:87-96. PubMed abstract
- Choudhury T, Solomonica A, Bagur R. The Evolut R and Evolut PRO transcatheter aortic valve systems. Expert Rev Med Devices. 2019;16(1):3-9. doi:10.1080/17434440.2019.1557045
- McDiarmid M, Kroboth S, Moreno ACP, et al. Comparison of self-expanding evolut pro+ and evolut r in the 34mm tavr, a single-center experience. J Am Coll Cardiol. 2021;77(18):1159. doi:10.1016/s0735-1097(21)02518-3
- dfornell. FDA clears Abbott Portico TAVR system to treat aortic valve disease. DAIC. Published September 20, 2021. Accessed May 19, 2022. https://www.dicardiology.com/article/fda-clears-abbott-portico-tavr-system-treat-aortic-valve-disease
- Center for Devices, Radiological Health. Portico Transcatheter Aortic Valve Implantation System – P190023. U.S. Food and Drug Administration. Published December 2, 2021. Accessed May 19, 2022. https://www.fda.gov/medical-devices/recently-approved-devices/portico-transcatheter-aortic-valve-implantation-system-p190023
- Takagi, H, Hari, Y, Nakashima, K, Kuno, T, Ando, T, and Group, A. Network meta-analysis of new-generation valves for transcatheter aortic valve implantation. Heart Vessels. 2019;34(12):1984-1992.
- Leon, MB, Mack, MJ, Hahn, RT, Thourani, VH, Makkar, R, Kodali, SK, Alu, MC, Madhavan, MV, et al. Outcomes 2 Years After Transcatheter Aortic Valve Replacement in Patients at Low Surgical Risk. J Am Coll Cardiol. 2021;77(9):1149-1161.
- Mack, MJ, Leon, MB, Thourani, VH, Makkar, R, Kodali, SK, Russo, M, Kapadia, SR, Malaisrie, SC, et al. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019;380(18):1695-1705.
- F, Bruno, F, Baldetti, L, De Filippo, O, Marengo, G, Breviario, S, Melillo, F, Thyregod, HGH, et al. Aortic valve replacement vs. balloon-expandable and self-expandable transcatheter implantation: A network meta-analysis. Int J Cardiol. 2021;337:90-98.
- Dagan, M, Yeung, T, Stehli, J, Stub, D, Walton, AS, and Duffy, SJ. Transcatheter Versus Surgical Aortic Valve Replacement: An Updated Systematic Review and Meta-Analysis With a Focus on Outcomes by Sex. Heart Lung and Circulation. 2021;30(1):86-99.
