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Clinical Background

Mitral regurgitation occurs when the mitral valve does not close completely, resulting in blood leaking back across the valve. Patients with moderate to severe mitral regurgitation are at greater risk of death and cardiovascular and respiratory complications.

There is no generally accepted pharmacological treatment for mitral regurgitation. Surgical treatment is strongly recommended for severe mitral regurgitation: either repairing the faulty mitral valve or replacing it with an artificial valve. In practice, however, only a fraction of the patients needing the surgery are able to access it [1].

Over four million people suffer from and 250,000 new patients are diagnosed each year with moderate to severe mitral regurgitation in the United States alone [2]. Annually, only approximately 50,000 of these patients undergo surgery in the United States [3].
The prevalence and incidence statistics are similar in Europe [3].

Mitral valve replacements and repairs account for approximately 35% and 65%, respectively, of the mitral valve operations [4]. The mitral valve repair is clinically superior to valve replacement in terms of both mortality and morbidity, and is therefore preferable whenever feasible [2]. Mitral repair is technically more demanding than mitral valve replacement, and may require longer extracorporeal circulation time [5].

Surgical repair is the preferred option, when the mitral valve is structurally repairable and when appropriate surgical skills are available [5].

However, mitral repair is technically more demanding than mitral valve replacement, and may require longer extracorporeal circulation time [5]. It is the invasiveness and complexity of the current procedures as well as the lack of surgical skills and expertise that hinder the surgical treatment [5].

Based on above we at Medtentia believe that there is a real need for simpler, faster and less traumatizing treatment methods for mitral valve dysfunction. We are convinced that the answer is Medtentia’s patented Helix concept.

 

 

Terminology

Mitral Valve
The mitral valve as one of the four valves in heart lies between the left atrium and the left ventricle. The mitral valve controls the blood flow from lungs between the left atrium and left ventricle. The mitral valve consists of two triangular-shaped flaps of tissue called leaflets that guard the opening of the valve. The leaflets of the mitral valve connect to the heart muscle through a ring called the annulus. Anchoring the mitral valve to the left ventricle are tendon-like cords, resembling the strings of a parachute, called chordae tendinae.

Mitral Regurgitation
Mitral valve regurgitation (or "leaky valve", “mitral insufficiency” or “mitral incompetence”) occurs when the mitral valve does not close tightly, letting blood leak backward in the heart. As a result, blood flow to the rest of the body decreases.

Mitral regurgitation can result from a variety of mechanisms related to degenerative or functional abnormalities of the mitral apparatus. Treatment of mitral valve regurgitation depends on severity of the conditions, progress of the disease and signs & symptoms. If not treated severe mitral regurgitation symptoms may lead to serious heart problems.

Mitral regurgitation may also be acute in case of e.g. chordal rupture. Acute severe mitral regurgitation is almost always symptomatic and requires surgical treatment, often immediate.

Mitral Regurgitation Symptoms
Mitral regurgitation symptoms depend on how severe the condition is and how fast the disease has developed. Typical mitral valve regurgitation symptoms include:

  • Tired and out of breath feeling
  • Fatigue often in conjunction with physical activity
  • Cough, during night time or in general when lying
  • Fast or irregular heart beats (palpitations)
  • Turbulent flow of blood through the heart
  • Turbulent flow of blood through the heart

Invasive Procedure/Operation
In heart surgery also called as “open heart surgery”. Refers to traditional method to perform heart surgery where patient is connected to the heart-lung machine while heart is arrested, chest is opened with an up to 14 inch incision (as in cardiac bypass operation) and the heart is arrested and opened to enable the surgeon to operate the heart.

 

 

References
  1. Mirabel et al. European Heart Journal 2007; 28:1358-1365
  2. Pedrazzini, GB, et al. Swiss Med Wkly, 2010. 140(3-4):36-43. Nkomo VT, et al. Lancet, 2006. 368:1005-11. Iung B, et al. Eur Heart J, 2003. 24:1231-43.
  3. STS U.S. Cardiac Surgery Database. Mitral Valve Repair and Replacement Patients: Incidence of Complications Summary. 2008. www.sts.org2. STS U.S. Cardiac Surgery Database. Mitral Valve Repair and Replacement Patients: Incidence of Complications Summary. 2008. www.sts.org
  4. Gummert J.F. et al. Thorac Cardiov Surg 2010; 58:379-386.
  5. Robert O. Bonow et al. JACC, ACC/AHA 2006 Guidelines for the management of Patients With Valvular Heart Desease, J. Am. Coll. Cardiol. 2006;48;el-el48 doi:10.1016/j.jacc.2006.05.021