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Peripheral Vascular Bypass Surgery for Diabetic Foot

A peripheral vascular bypass, also called a lower extremity bypass, is the surgical rerouting of blood flow around an obstructed artery that supplies blood to the legs and feet. This surgery is performed when the buildup of fatty deposits (plaque) in an artery has blocked the normal flow of blood that carries oxygen and nutrients to the lower extremities. Bypass surgery reroutes blood from above the obstructed portion of an artery to another vessel below the obstruction.


A bypass surgery is named for the artery that will be bypassed and the arteries that will receive the rerouted blood. The three common peripheral vascular bypass surgeries are:


Aortobifemoral bypass surgery, which reroutes blood from the abdominal aorta to the two femoral arteries in the groin.
Femoropopliteal bypass (fem-pop bypass) surgery, which reroutes blood from the femoral artery to the popliteal arteries above or below the knee.
Femorotibial bypass surgery, which reroutes blood between the femoral artery and the tibial artery.

A substitute vessel or graft must be used in bypass surgeries to reroute the blood. The graft may be a healthy segment of the patient’s own saphenous vein (autogenous graft), a vein that runs the entire length of the thigh. A synthetic graft may be used if the patient’s saphenous vein is not healthy or long enough, or if the vessel to be bypassed is a larger artery that cannot be replaced by a smaller vein.





Purpose


Peripheral vascular bypass surgery is performed to restore blood flow (revascularization) in the veins and arteries of people who have peripheral arterial disease (PAD), a form of peripheral vascular disease (PVD). People with PAD develop widespread hardening and narrowing of the arteries (atherosclerosis) from the gradual build-up of plaque. In advanced PAD, plaque accumulations (atheromas) obstruct arteries in the lower abdomen, groin, and legs, blocking the flow of blood, oxygen, and nutrients to the lower extremities (legs and feet). Rerouting blood flow around the blockage is one way to restore circulation. It relieves symptoms in the legs and feet, and helps avoid serious consequences such as heart attack, stroke, limb amputation , or death.





Description


The circulatory system delivers blood, oxygen, and vital nutrients to the limbs, organs, and tissues throughout the body. This is accomplished via arteries that deliver oxygen-rich blood from the heart to the tissues and veins that return oxygen-poor blood from organs and tissues back to the heart and lungs for re-oxygenation. In PAD, the gradual accumulation of plaque in the inner lining (endothelium) of the artery walls results in widespread atherosclerosis that can occlude the arteries and reduce or cut off the supply of blood, oxygen, and nutrients to organ systems or limbs.


Peripheral vascular bypass surgery is a treatment option when PAD affects the legs and feet. PAD is similar to coronary artery disease (CAD), which leads to heart attacks and carotid artery disease (CAD), which causes stroke. Atherosclerosis causes each of these diseases. Most often, atherosclerotic blockage or narrowing (stenosis) occurs in the femoral arteries that supply the thighs with blood or in the common iliac arteries, which are branches of the lower abdominal aorta that also supplies the legs. The popliteal arteries (a portion of the femoral arteries near the surface of the legs) or the posterior tibial and peroneal arteries below the knee (portions of the popliteal artery) can be affected.


Just as coronary artery disease can cause a heart attack when plaque blocks the arteries of the heart, or blockage in the carotid artery leading to the brain can cause a stroke, occlusion of the peripheral arteries can create life-threatening conditions. Plaque accumulation in the peripheral arteries blocks the flow of oxygen-carrying blood, causing cells and tissue in the legs and feet to die from lack of oxygen (ischemia) and nutrition. Normal growth and cell repair cannot take place, which can lead to gangrene in the limbs and subsequent amputation. If pieces of the plaque break off, they can travel from the legs to the heart or brain, causing heart attack, stroke, or death.


The development of atherosclerosis and PAD is influenced by heredity and also by lifestyle factors, such as dietary habits and levels of exercise . The risk factors for atherosclerosis include:


high levels of blood cholesterol and triglycerides.
high blood pressure (hypertension)
cigarette smoking or exposure to tobacco smoke
diabetes, types 1 and 2
obesity
inactivity, lack of exercise
family history of early cardiovascular disease

Sometimes the body will attempt to change the flow of blood when a portion of an artery is narrowed by plaque. Smaller arteries around the blockage begin to take over some of the blood flow. This adaptation of the body (collateral circulation) is one reason for the absence of symptoms in some people who have PAD. Another reason is that plaque develops gradually as people age. Symptoms usually don’t occur until a blockage is over 70%, or when a piece of plaque breaks off and blocks an artery completely. Blockage in the legs reduces or cuts off circulation, causing painful cramping during walking, which is relieved on rest (intermittent claudication). The feet may ache even when lying down at night.


When narrowing of an artery occurs gradually, symptoms are not as severe as they are when sudden, complete blockage occurs. Sudden blockage does not allow time for collateral vessels to develop, and symptoms can be severe. Gradual blockage creates muscle aches and pain, cramping, and sensations of fatigue or numbness in the limbs; sudden blockage may cause severe pain, coldness, and numbness. At times, no pulse can be felt, a leg may become blue (cyanotic) from lack of oxygen, or paralysis may occur.


When the lower aorta, femoral artery, and common iliac arteries (all in the lower abdominal and groin areas) are blocked, gradual narrowing may produce cramping pain and numbness in the buttocks and thighs, and men may become impotent. Sudden blockage will cause both legs to become painful, pale, cold, and numb, with no pulse. The feet may become painful, infected, or even gangrenous when gradual or complete blockage limits or cuts off circulation. Feet may become purple or red, a condition called rubor that indicates severe narrowing. Pain in the feet or legs during rest is viewed as an indication for bypass surgery because circulation is reduced to a degree that threatens survival of the limb.


Early treatment for PAD usually includes medical intervention to reduce the causes of atherosclerosis, such as lowering cholesterol and blood pressure, smoking cessation , and reducing the likelihood of clot formation. When these measures are not effective, or an artery becomes completely blocked, lower extremity bypass surgery may be performed to restore circulation, reduce foot and leg symptoms, and prevent limb amputation.

Bypass surgery is an open procedure that requires general anesthesia. In femoropopliteal bypass or femorotibial bypass, the surgeon makes an incision in the groin and thigh to expose the affected artery above the blockage, and another incision (behind the knee for the popliteal artery, for example) to expose the artery below the blockage. The arteries are blocked off with vascular clamps. If an autogenous graft is used, the surgeon passes a dissected (cut and removed) segment of the saphenous vein along the artery that is being bypassed. If the saphenous vein is not long enough or is not of good quality, a tubular graft of synthetic (prosthetic) material is used. The surgeon sutures the graft into an opening in the side of one artery and then into the side of the other. In a femoropopliteal bypass, for example, the graft extends from the femoral artery to the popliteal artery. The clamps are then removed and the flow of blood is observed to make sure it bypasses the blocked portion of the affected artery.



Aortobifemoral bypass surgery is conducted in much the same way, although it requires an abdominal incision to access the lower portion of the abdominal aorta and both femoral arteries in the groin. This is generally a longer and more difficult procedure. Synthetic grafts are used because the lower abdominal aorta is a large conduit, and its blood flow cannot be handled by the smaller saphenous vein. Vascular surgeons prefer the saphenous vein graft for femoropopliteal or femorotibial bypass surgery because it has proven to stay open and provide better performance for a longer period of time than synthetic grafts. Bypass surgery patients will be given heparin, a blood thinner, immediately after the surgery to prevent clotting in the new bypass graft.

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FAQ

A NPP provides access to post-approval drugs that are approved and commercially available in one or more country, other than the patient’s home country.

 

No. Companies are not required to provide their products through a formal NPP.

 

  • Dealing with unsolicited patient request for drug in an ethical and regulatory controlled manner
  • Providing exposure to, and experience with, company products to physicians in additional countries and build a larger KOL network and future advocates
  • Providing new products to patients who would move to commercial drug when it becomes available in these countries
  • Generating additional revenues in countries that allow you to charge for drugs supplied on a named patient basis

Companies can provide drug to patients in any country in which they have not yet received marketing approval. This includes countries in which a company plans to seek marketing approval, as well as those countries in which a company does not plan to seek marketing approval.

 
 

INFORMATION FOR PATIENTS

As a named patient medicines you may find yourself in the frightening position that you have a serious condition or illness and the treatment you need is not available in your home country. It is possible that the medicines are available outside your country and if your physician decides that these drugs would be suitable for the treatment of your illness, they then face the challenge of obtaining them for you. We help physicians across the world access medicines which are not approved or licensed in their country, but may be required to meet the special needs of an individual patient. The service we provide not only locates and supplies the required medicines but ensures that the physician has all the quality assurance and supporting clinical information they will need to safely prescribe it to you. If you are confronted with a situation where a drug is not available to you, talk to your physician or healthcare professional about Named Patient Program and ask them to contact us. We will then work directly with your physician to help them in patient access program and understand what options are available.

 

 

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Orphan Drugs

1.

Request for medicine

Patient who has serious problem request for medicine

 

2.

Drug Verify

Internal processing of drug verifications at GM Global

 

3.

Prescription

Recognizing best source for the specific prescription

 

4.

GDP Instruction

Import medicine under the GDP instruction

 

5.

QA check

Supply drugs to concerned healthcare provider after QA check

 

5.

QA check

Supply drugs to concerned healthcare provider after QA check

 

FAQ

A NPP provides access to post-approval drugs that are approved and commercially available in one or more country, other than the patient’s home country.

 

No. Companies are not required to provide their products through a formal NPP.

 

  • Dealing with unsolicited patient request for drug in an ethical and regulatory controlled manner
  • Providing exposure to, and experience with, company products to physicians in additional countries and build a larger KOL network and future advocates
  • Providing new products to patients who would move to commercial drug when it becomes available in these countries
  • Generating additional revenues in countries that allow you to charge for drugs supplied on a named patient basis

Companies can provide drug to patients in any country in which they have not yet received marketing approval. This includes countries in which a company plans to seek marketing approval, as well as those countries in which a company does not plan to seek marketing approval.

 
 

INFORMATION FOR PATIENTS

As a named patient medicines you may find yourself in the frightening position that you have a serious condition or illness and the treatment you need is not available in your home country. It is possible that the medicines are available outside your country and if your physician decides that these drugs would be suitable for the treatment of your illness, they then face the challenge of obtaining them for you. We help physicians across the world access medicines which are not approved or licensed in their country, but may be required to meet the special needs of an individual patient. The service we provide not only locates and supplies the required medicines but ensures that the physician has all the quality assurance and supporting clinical information they will need to safely prescribe it to you. If you are confronted with a situation where a drug is not available to you, talk to your physician or healthcare professional about Named Patient Program and ask them to contact us. We will then work directly with your physician to help them in patient access program and understand what options are available.