Senior vice president of leading medical technology company Medtronic Tony Semedo speaks about company's robust product portfolio highlighting the need to develop a protocol for screening aortic disease patients in a timely manner considering the asymptomatic nature of the disease taking into account the lack of healthcare infrastructure for the same in India. In an interview with Shardul Nautiyal, he also gives a low down about the treatment options available which include drug-coated balloons, atherectomy, stents, PTA balloons and a wide variety of accessories to aid the delivery of therapy. Excerpts:  

Kindly give a perspective on the scenario of aortic disease globally and in India.
Aortic aneurysm is among the top 10 leading cause of death in the US and around 600,000 people are affected with Aortic diseases in India.  Given Medtronic robust product portfolios, there is a need to first develop a protocol to screen patients who fall within the high risk factors for aortic diseases. Lack of adequate infrastructure in the country also need to be addressed on a priority basis. Very few hospitals in India have a dedicated cath lab or Operating Room (OR) for aortic endovascular repairs to be performed. Physicians generally depend on utilizing a cath lab to do their procedures.  Lack of facilities which limit the ability of treating physicians to perform Aortic endovascular procedures is also one of the biggest barriers among others.

As many vascular surgeons do not have the opportunity to perform endo-vascular procedures, majority of procedures are performed with open surgical procedure. Therefore, there are only around 40 to 60 vascular surgeons in India who perform endovascular surgeries as their primary procedure for patients who present with an Abdominal Aortic Aneurysm (AAA) or Thoracic Aortic Aneurysm.

A vascular surgeon is usually the physician that makes this determination. Typically if an aneurysm is less than 3 to 4 cm in size, then doctors recommend to keep it under observation and get it screened every 6 to12 months. If the size is 4.5 to 5 cm, then usually the patients are advised to go for surgeries.

What is aortic aneurysm and its scenario in India in particular?
The aortic aneurysms can either be abdominal (occurring in the abdomen) or thoracic (occurring in the thoracic region) of the body. The aorta, about the thickness of a garden hose, runs from your heart through the center of your chest and abdomen. The aorta is the main conduit and reservoir of oxygenated blood in the body. A large elastic artery, it is composed of three layers.  Because the aorta is the body's main supplier of blood, a ruptured abdominal aortic aneurysm can cause life-threatening bleeding.  

An aortic aneurysm is a bulging, dilation or ballooning in the wall of a blood vessel, usually an artery, that is due to weakness or degeneration that develops in a portion of the artery wall. Just like a balloon, the aneurysm enlarges, stretching the walls of the artery thinner which compromises the artery wall's ability to stretch any further. At this point, an aneurysm is at risk of rupturing and causing potentially fatal bleeding.

India has no statistical evidence on the prevalence of this disease but going by US statistics, it affects about 1% of the population above 60 years with one or more risk factors such as smoking, hypertension, age (men over 60; women over 65) suffering from coronary artery disease (CAD), people who have already undergone coronary artery bypass grafting (CABG)  and have a family history of aneurysm.

Since this disease is asymptomatic before rupture, a majority of patients are undiagnosed. In the US, around 250,000 people are affected with Aortic diseases. Out of these, only around 70,000 patients receive treatment.  On the other hand in India, around 600,000 people are affected with Aortic diseases, but only 4,000 receive treatment. Awareness is low for aortic, peripheral and endovenous therapies as the diseases generally affect older adults. Access to health insurance coverage is also a key challenge.  

Kindly elaborate how Medtronic is planning to address the disease and also its severity taking the global scenario into account.
Leveraging decades of clinical experiences and data, Medtronic’s core technologies for treating abdominal aortic aneurysm (AAA) and descending thoracic disease are the Endurant and Valiant product lines which have also proven in more than 280,000 patients globally.

Around 2,00,000 patients globally are treated with Endurant stent graft. It can be used in 1 out of every 2 vascular procedures. Our mission to improve patient outcomes drives our commitment to build on our success and invest in complementary innovative technology that will allow physicians to treat more complex aortic disease.

Chronic Venous Insufficiency (CVI) occurs when valves in the veins of the leg no longer function properly.  This disease allows blood to flow backward, or reflux, resulting in enlarged, or varicose veins that become painful and can limit quality of life. Left untreated, venous insufficiency, in some cases, can progress, and cause leg pain, leg and ankle swelling, leg heaviness and fatigue, skin changes or rashes, ulcers and open wounds.

Globally venous insufficiency affects more than 192 million people and is common in women who have had two or more pregnancies. CVI disease has risk factors that include age, pregnancy, obesity, extended periods of standing and sitting. This is a new and emerging therapy in India. Some of key symptoms include varicose veins, leg pain, aching, cramping, leg or ankle swelling, leg heaviness and fatigue, skin changes or rashes, ulcers, open wounds, or sores.