TREATING

Methods of treating aortic stenosis

Aortic stenosis can only be treated “mechanically.” Medications can relieve the symptoms but cannot correct the malfunction of the heart valve. There are only two ways of treating aortic stenosis that improve both the patient’s prognosis and their quality of life:
 
  • Open-heart surgery
  • Transcatheter aortic valve implantation (TAVI)

Method 1: Open-heart surgery

In open-heart surgery, the malfunctioning natural cardiac valve is replaced by an artificial valve. The patient is put under general anesthesia, the rib cage is opened, and the heart is artificially stopped. The heart-lung machine keeps the patient alive while the stenotic aortic valve is removed and replaced by a bioprosthesis or artificial valve.
 
For many years, this was the only treatment option. However, it had a high mortality rate amongst risk patients. As a result, up to a third of patients were rejected as candidates for surgery and could not be treated.

Method 2: Transkatheter aortic valve implantation (TAVI)

Transcatheter aortic valve implantation is a minimally invasive therapeutic option for patients; in recent years it has received more and more attention. The biological replacement valve is folded over itself and guided to the correct position via a catheter inserted through the groin. Once in position, it is unfolded, presses the natural valve against the wall of the heart and immediately takes over its function.
 
Studies have shown that in comparison to open-heart surgery, this method yields at least comparable outcomes in patients at high and moderate risk, and in many respects is even superior.
 
Consequently, the indication is being steadily expanded and is currently also being studied in patients at lower risk.
 
The ALLEGRA™ bioprosthesis by New Valve Technology consists of bovine pericardium, a material known for its ruggedness and durability. The valve leaflets are sewn into a stent made of nitinol.

Please talk to your doctor about this option. He or she is the only one who can help decide which treatment option is best for you. They will give you comprehensive information, assess all of the risks and benefits, and work with you to make a decision.


Treatment phases

Below we have provided an overview of the phases of undergoing an ALLEGRA™ transcatheter aortic valve implantation (TAVI). This information may change somewhat depending on your overall health and the extent of your disease. Please make sure you talk to your doctor about these details.


Phase 1
Patients are given either twilight anesthesia or local anesthesia in the groin where the incision will be made.

Phase 2
The ALLEGRA™ bioprosthesis is folded over itself and loaded into a catheter. In a procedure known as the transfemoral approach, a small incision is made into the groin, and an introducer sheath is used to guide the bioprosthesis into the femoral artery and to the aorta. This transfemoral approach leads the catheter with the ALLEGRA™ bioprosthesis to the damaged cardiac valve.


Phase 3
A special x-ray monitor allows the team of physicians to position the catheter with the biological heart valve at the site of the calcified aortic valve. The ALLEGRA™ bioprosthesis is released, unfolds to reach its full size, and presses the defective valve to the side. The new valve takes over its function immediately.


Phase 4
The catheter and introducer sheath are removed. The small incision into the groin is closed, and the procedure is complete. Depending on their overall health, patients may be able to leave the hospital within only a few days.

 


Living with a cardiac valve

Back home again quickly
In most cases, patients are back on their feet within 24 to 48 hours after receiving an ALLEGRA™ transcatheter aortic valve implantation and can leave the hospital after only a few days. Your doctor will decide on an individual basis whether you need cardiac rehabilitation measures as well.
 
 

Please note
Always make sure you consult with your doctor when it comes to your diagnosis, treatment and recovery, especially if you suddenly experience pain, fever or other complaints during your recovery. All of the content on this web page is for information purposes only; it is no substitute for a personal consultation with your physician.


Follow-up care
Usually patients take blood thinners for a few months immediately after the procedure. Regular monitoring needs to be done by a cardiologist or family doctor.
 

Please note
Always make sure you consult with your doctor when it comes to your diagnosis, treatment and recovery, especially if you suddenly experience pain, fever or other complaints during your recovery. All of the content on this web page is for information purposes only; it is no substitute for a personal consultation with your physician.


Medical interventions and operations
Always inform your doctors and dentists if you have had an aortic valve prosthesis implanted. Preventive measures against endocarditis are required before certain procedures. MRIs can be safely conducted up to 3.0 Tesla in patients with an ALLEGRA™ bioprosthesis.

Please note
Always make sure you consult with your doctor when it comes to your diagnosis, treatment and recovery, especially if you suddenly experience pain, fever or other complaints during your recovery. All of the content on this web page is for information purposes only; it is no substitute for a personal consultation with your physician.


Diet and exercise
Regular exercise and a balanced diet are both important parts of a healthy lifestyle. And patients who undergo aortic valve replacement should make a point of increasing their stamina by getting exercise, especially in the form of endurance sports. However, extreme exertion or performance athletics are not advised after this procedure. Your limits will be determined by the extent of prior heart damage and any related illnesses.
Please note
Always make sure you consult with your doctor when it comes to your diagnosis, treatment and recovery, especially if you suddenly experience pain, fever or other complaints during your recovery. All of the content on this web page is for information purposes only; it is no substitute for a personal consultation with your physician.
 

Please note
Always make sure you consult with your doctor when it comes to your diagnosis, treatment and recovery, especially if you suddenly experience pain, fever or other complaints during your recovery. All of the content on this web page is for information purposes only; it is no substitute for a personal consultation with your physician.


11881-000-EN - Rev.04

CAUTION: Please note that the following pages are exclusively reserved for Health Care Professionals in countries with applicable health authority product registrations. To the extent this site contains information intended for use by licensed medical professionals, such materials are not intended to offer professional medical advice. Prior to use, please consult device labeling for prescriptive information and operating instructions. Please contact your Biosensors International representative for availability or the products and registration status.

The law restricts these devices to sale by or on the order of a physician. Prior to use, it is important to read the "Instructions for Use" supplied with these devices for indications, contraindications, suggested procedures, warnings, and precautions.

Biosensors’ interventional cardiology products, including BioMatrix NeoFlex™, BioMatrix™ Alpha, BioFreedom™, BioFreedom™ Ultra, BMX-J® and RISE™ NC, are not available for sale in the United States and certain other countries. ALLEGRA™ is a product of NVT GmbH. Blue Sail Medical Co., Ltd is the ultimate parent company of NVT GmbH and Biosensors International Group, Ltd. and its subsidiaries are collaborating for the commercialization of the ALLEGRA™ device.

BioMatrix NeoFlex, BioMatrix Alpha, BioFreedom, BioFreedom Ultra, BMX-J, Juno, S-Stent and Rise NC are trademarks or registered trademarks of Biosensors International Group, Ltd. ALLEGRA is a trademark or registered trademark of NVT AG. All other cited trademarks are the property of their respective owners.