Aortic valve disease, a condition affecting millions worldwide, has seen a revolutionary shift in treatment options over the past few years. With the advent of minimally invasive aortic valve replacement (MIAVR), patients now have access to safer, more effective, and less traumatic treatment options.
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.
Understanding Aortic Valve Disease
The aortic valve plays a crucial role in cardiovascular health, regulating blood flow from the heart to the aorta. Diseases like aortic stenosis and regurgitation can impede this function, leading to severe health complications. Traditionally, open-heart surgery was the standard treatment, posing significant risks and a lengthy recovery.
Evolution of Aortic Valve Replacement
Aortic valve replacement has evolved dramatically. From open-heart surgery requiring extensive recovery time and posing considerable risks, the medical field has progressed towards less invasive techniques. This evolution reflects a broader trend in medicine towards procedures that minimize patient discomfort and recovery time while maximizing success rates.
Minimally Invasive Aortic Valve Replacement (MIAVR)
What is MIAVR?
MIAVR is a cutting-edge technique offering aortic valve replacement through smaller incisions and often using catheter-based approaches. This method significantly reduces recovery time, hospital stays, and postoperative complications.
Techniques and Technologies
MIAVR techniques include transcatheter aortic valve replacement (TAVR) and endoscopic approaches. Technological advancements in imaging, device design, and surgical tools have been pivotal in enhancing the precision and success of these procedures.
What are the risks of minimally invasive aortic valve replacement?
There are certain risks with any type of surgery. Your risks will vary based on your medical condition, your age, and other factors. Be sure to talk with your healthcare provider about any concerns that you have.
Most people with minimally invasive aortic valve replacement will have a successful outcome. However, there are some possible risks. These include:
- Infection
- Bleeding
- Irregular heart rhythms
- Blood clots leading to stroke or heart attack
- Complications from anesthesia
Certain factors increase the risk of complications. Some of these are:
- Chronic illness
- Other heart conditions
- Lung problems
- Increased age
- Being overweight
- Being a smoker
- Infections
Comparing Available Medical Devices
Sapien 3 Valve by Edwards
Edwards Lifesciences Corp’s Sapien 3 transcatheter heart valve is a third-generation bioprosthetic valve derived from cow heart tissue. It replaced the second-generation Sapien XT valve on the market.
The Sapien 3 is associated with a reduced rate of pacemaker insertion in follow-up visits than other transcatheter heart valves.3 It also necessitates a shorter hospital stay after TAVR, owing to a significant reduction in the incidence of paravalvular regurgitation (PVL), or leakage around the valve.
Evolut R
The CoreValve Evolut R device (Medtronic) (currently available in four device sizes of 23, 26, 29, and 34 mm, allowing the treatment of native valves with a perimeter of 56.5–94.2 mm) consists of a tricuspid valve obtained from porcine pericardial tissue, mounted and sutured inside a self-expandable nitinol frame.
The lower part of the device has a high radial force that allows for the self-expansion and exclusion of native calcified valve leaflets. The central portion of the stent supports the valve.
As compared with the previous generation of CoreValve devices, the Evolut R provides several refinements to improve anatomical fit, annular sealing, and durability. In particular, the device is designed to enable recapturability and repositionability.
The Evolut R frame is tailored to reduce the overall height while preserving the height of the pericardial skirt (13 mm) with an extended skirt of the inflow tract to provide a seal against PVR. In addition, cell geometry has been redesigned to achieve optimized radial force.
Recently, two studies conducted in Europe and the United States showed low rates of 30-day mortality (< 2.5%) and stroke (< 5%). The frequency of permanent pacemaker implantation remained < 17% in both studies, while the rate of mild PVR was identified in 7.7% and 5.3% of cases, respectivelyÂ
Portico
The Portico valve (St. Jude Medical, Inc.) is composed of a self-expanding stent, bovine leaflets, and a porcine pericardial sealing cuff. The large cell area and the annular positioning allow easy engagement of the coronary ostia after implantation. The large cell area also minimizes the risk of paravalvular leakage by allowing valve tissue to conform around calcific nodules at the annulus.
Clinical studies have been reported on alternative access sites including transaxillary, transaortic, and subclavian access, and case studies are currently underway to support this issue. The Portico valve is designed to be recaptured and repositioned at the implantation site until it is fully deployed.
The Portico Valve TF EU study studied patients in Europe and Australia. The 30-day results of this large trial (n = 222) demonstrated excellent safety and efficacy of the complete Portico valve family.
The valve had exceptional hemodynamic performance (8.3 mm Hg) as well as improvement in New York Heart Association class functional status. There were also lower rates of mortality (3.6%), disabling stroke (3.2%), and 94.7% of patients had less than mild paravalvular leak, and no patients had severe paravalvular leak.
Accurate Neo
The Acurate Neo aortic bioprosthesis (Symetis) is a second-generation valve with flaps composed of porcine pericardium sewn onto a stent made of self-expanding nitinol, covered both externally and internally by a porcine pericardium skirt antileak
The device includes three stabilization arches for the axial alignment to the aortic annulus, a top crown for capping the aortic annulus, and a bottom that is open to the full distribution on the native valve.
The prosthesis can be implanted through both the transapical (28 F) and the transfemoral (18 F) routes using a simple two-step deployment and stable positioning. The Acurate Neo comes in three different sizes: small (21- to 23-mm aortic annulus), medium (23- to 25-mm aortic annulus), and large (25- to 27-mm aortic annulus)
After first-in-human and small single-center studies,20-22 the results of the post-CE SAVI 2 registry, which enrolled 1,000 patients, were presented at the EuroPCR 2016 meeting. At 30 days, the mortality rate was 1.3%, stroke, and pacemaker implantation rates were very low (1.9% and 8.2%, respectively), and more than mild paravalvular leak was reported in 4% of patients (Figure 3).23
Benefits of MIAVR
MIAVR offers numerous benefits over traditional surgery. These include reduced trauma and pain, lower risk of infection, shorter hospital stays, and quicker return to normal activities. Additionally, MIAVR is particularly advantageous for high-risk patients who may not be suitable for open-heart surgery.
Verdict
There are numerous FDA-approved transcatheter aortic valves available on the market for your TAVR treatment. Now that you have a general understanding of these possibilities, we hope you can make a better-informed decision with your doctor.
To summarize, no single valve is appropriate for every patient, however, clinical studies indicate that the Sapien 3 series of valves has the most favorable profile today
“The SAPIEN 3 valve has demonstrated 99% freedom from death and disabling stroke at one year, 90% survival at five years, and is the only valve with a THV-in-THV indication,” said Larry Wood, Edwards’ corporate vice president and group president, transcatheter aortic valve replacement and surgical structural heart.
Conclusion
The advancements in minimally invasive aortic valve replacement represent a significant leap forward in cardiac care. By offering a safer, less invasive, and highly effective option, MIAVR is transforming the lives of patients with aortic valve disease. As technology continues to advance, we can anticipate further improvements in these procedures and devices, enhancing patient care and outcomes.
References
- https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/aortic-valve-replacement-minimally-invasive
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6652095/
- https://citoday.com/articles/2017-mar-apr/current-tavr-devices
- https://www.prnewswire.com/news-releases/five-year-data-from-partner-3-trial-demonstrate-excellent-survival-for-patients-receiving-edwards-sapien-3-valve-301965283.html#:~:text=%22The%20SAPIEN%203%20valve%20has,replacement%20and%20surgical%20structural%20heart.
