FDA expands use of Xarelto to treat, reduce recurrence of blood clots (DVT)

November 2, 1012- The U.S. Food and Drug Administration today expanded the approved use of Xarelto (rivaroxaban) to include treating deep vein thrombosis (DVT) or pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE following initial treatment.

Blood clots occur when blood thickens and clumps together. DVT is a blood clot that forms in a vein deep in the body. Most deep vein blood clots occur in the lower leg or thigh. When a blood clot in a deep vein breaks off and travels to an artery in the lungs and blocks blood flow, it results in a potentially deadly condition called PE.

Xarelto is already FDA-approved to reduce the risk of DVTs and PEs from occurring after knee or hip replacement surgery (July 2011), and to reduce the risk of stroke in people who have a type of abnormal heart rhythm called non-valvular atrial fibrillation (November 2011).

The FDA reviewed Xarelto’s new indication under the agency’s priority review program, which provides an expedited six-month review for drugs that offer major advances in treatment or that provide treatment when no adequate therapy exists.

“Xarelto is the first oral anti-clotting drug approved to treat and reduce the recurrence of blood clots since the approval of warfarin nearly 60 years ago,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
Other drugs approved by FDA to treat or reduce the risk of blood clots include Lovenox (enoxaparin), generic versions of enoxaparin, Arixtra (fondaparinux), Fragmin (dalteparin), Coumadin (warfarin), and heparin.

The safety and effectiveness of Xarelto for the new indications were evaluated in three clinical studies. A total of 9,478 patients with DVT or PE were randomly assigned to receive Xarelto, a combination of enoxaparin and a vitamin K antagonist (VKA), or a placebo. The studies were designed to measure the number of patients who experienced recurrent symptoms of DVT, PE or death after receiving treatment.

Results showed Xarelto was as effective as the enoxaparin and VKA combination for treating DVT and PE. About 2.1 percent of patients treated with Xarelto compared with 1.8 percent to 3 percent of patients treated with the enoxaparin and VKA combination experienced a recurrent DVT or PE. Additionally, results from a third study showed extended Xarelto treatment reduced the risk of recurrent DVT and PE in patients. About 1.3 percent of patients treated with Xarelto compared with 7.1 percent of patients receiving placebo experienced a recurrent DVT or PE.

The major side effect observed with Xarelto is bleeding, similar to other anti-clotting drugs.
Xarelto is marketed by Raritan, N.J.-based Janssen Pharmaceuticals Inc.

November is Diabetes Awareness Month. Do you know that people with diabetes are at an increased risk for Cardiovascular Disease?

According to the American Heart Association (AHA), diabetes affects nearly 24 million Americans (7.8 percent of the population). The AHA also considers diabetes to be one of the six major controllable risk factors for cardiovascular disease.

In the U.S., a new case of diabetes is diagnosed every 30 seconds; more than 1.6 million people are diagnosed each year.

•  Forty-one children are diagnosed with type 1 diabetes each and every day.
•  More than $174 billion is spent annually on healthcare costs related to diabetes in the United States.
•  Diabetes kills one American every three minutes.

 
Why are people with diabetes at increased risk for Cardiovascular Disease?

Heart disease and  stroke are the #1 causes of death and disability among people with type 2 diabetes. In fact, at least 65 percent of people with diabetes die from some form of heart disease or stroke.

 Adults with diabetes are two to four times more likely to have heart disease or a stroke than adults without diabetes.

Diabetes is treatable, but even when glucose levels are under control it greatly increases the risk of heart disease and stroke. People with diabetes, particularly type 2 diabetes, often have conditions that contribute to their risk for developing cardiovascular disease.

While poor health habits aren’t good for anyone, they’re especially destructive for people with diabetes, making it harder to manage the condition and increasing your risk for dangerous complications such as peripheral artery disease, critical limb ischemia, and loss of limbs.


Common Risk Factors
 
High blood pressure (hypertension) -has long been recognized as a major risk factor for cardiovascular disease. When patients have both hypertension and diabetes, which is a common combination, their risk for cardiovascular disease doubles.

Obesity- Obesity is a major risk factor for cardiovascular disease and has been strongly associated with insulin resistance. Weight loss can improve cardiovascular risk.

Lack of physical activity- Exercising and losing weight can prevent or delay the onset of type 2 diabetes and  reduce blood pressure and help reduce the risk for heart attack and stroke. Studies show that exercise lowers blood sugar and keeps it down for several hours afterward.

Smoking can increase your risk of developing serious diabetic complications: coronary heart disease, stroke, and peripheral vascular disease Smoking puts individuals, whether or not they have diabetes, at higher risk for heart disease and stroke.

Diabetes can be well-managed if you implement a healthier lifestyle. By controlling your risk factors, diabetes patients may avoid or delay the development of heart and blood vessel disease which can ultimately save your life..

South Florida Vascular Associates Announces Its First In-Office Surgical Placement of the Newly Approved Flexible iDev Supera Stent for PAD

iDev Supera® Stent Is The First Flexible Artery Stent Allowing Endovascular Surgeons To  Restore Blood Flow To Parts Of The Body Never Before Possible


 Drs. Warren Swee and William Julien, board certified and fellowship trained interventional radiologists, are pleased to announce that they recently implanted their first iDev Flexible Supera Stent in their office - based catherization lab. South Florida Vascular Associates is one of the first office-based cath labs in South Florida to do this procedure. The stent was used to treat a patient who had critical stenosis, or blockage of the superficial femoral artery and the popliteal artery, which is located behind the knee and supplies blood to the knee joint and muscles in the thigh and calf.

“Until recently, stents were hard, inflexible cylinders that could only be used in certain areas of the body, but if a stent was needed in an area such as behind a knee which bends, the older hard, inflexible stents would not hold”, said Dr. Warren Swee. Prior to the development of the new titanium flexible stent, this area was very difficult to treat.

According to the American Heart Association, peripheral artery disease (PAD) of the lower extremities affects approximately 8 million -12 million people in the United States alone. People suffering from PAD have pain, or claudication while walking, often limiting their life-style activities. In order for doctors to open-up the diseased arteries and re-establish blood blow to the lower extremities, stents are often used to keep the arteries open. Stents are a less invasive alternative to surgery for some conditions, which results in a lower procedure-related complication rate and potentially have better outcomes.

“The iDev Stent is a relatively new stent that has good data accumulating about its efficacy”, said Dr. William Julien. This stent is approved for use in the billary ducts of the liver, but we often use it off-label to treat hard to reach areas in the body that require a stent with flexibility needed for areas that bend, such as behind the knee. The new stent’s unique design and composition is improving patient outcomes.

Alberto's Story: Varicoceles

IS SEX PAINFUL?

IS YOUR SCROTUM SWOLLEN AND HURTS?

IS YOUR WIFE HAVING TROUBLE GETTING PREGNANT?

ANSWER YES TO ANY OF THESE QUESTIONS AND YOU MAY SUFFER FROM A COMMON PROBLEM KNOWN AS VARICOCELES WHICH IS OFTEN MISTREATED PUTTING MEN THROUGH UNNECESSARY PAIN AND SURGERY

 It is estimated that 15-percent of men between the ages of 25-40, at some point in their lives will suffer from varicocele. Simply put, its pain and swelling of the testicles caused by tangled blood vessels and weak defective valves in the scrotum resulting in blood pooling.  When the valves in the testis work properly, they only allow the blood to flow away from the testicle, but sometimes these one-way valves can fail and reverse the flow of blood.

“It’s often described as feeling like a bag of worms,” says Dr. William Julien, interventional radiologist and medical director of South Florida Vascular Associates. Sometimes varicocele causes no symptoms and is harmless, but sometimes it causes pain, testicular shrinkage and low sperm count resulting in fertility problems.

39-year-old Alberto Gonzalez, a grounds maintenance worker suffered with it for five excruciating months. “The pain became so severe I was unable to sit for any length of time and driving the tractor for work was excruciating for me.  Even sex was painful,”

This extremely active man, who works out regularly and takes long walks with his wife, could no longer enjoy the lifestyle he was accustomed to.

“I could barely do anything without experiencing pain.”

After many tests and seeing numerous doctors, Alberto was finally diagnosed with varicocele and underwent a procedure called Minimally Invasive Varicocele Embolization.

Dr. Julien says, “This procedure is done on an outpatient basis, requires light anesthesia known as twilight sedation, is less painful, has fewer complications and recovery is much faster.”

Performed by an interventional radiologist, first a tiny incision is made in the groin. Then using x-ray guided imaging a small catheter is inserted to close off the vein with small metal coils and sclerosant medication may be injected to shrink it. The procedure takes about 30 minutes and the patient goes home shortly afterwards with only a band aid at the puncture site.

While this procedure is the gold standard for treating varicocele, unfortunately many urological surgeons still do it the old fashioned way, making a large incision in the scrotum, requiring general anesthesia and a long, painful recovery. It’s called Varicocele Ligation Surgery.

Dr. Julien says minimally invasive varicocele embolization is underutilized and patients need to educate themselves and find an interventional radiologist who performs the procedure which is much easier on the patient.

Alberto feels lucky he found Dr. Julien. “I was back to my old active self within 10 days. My wife and I have been trying to start a family, but she hasn’t gotten pregnant. Maybe now she will.”

Frank's Story: Peripheral Artery Disease

NEWER ILIAC ARTERY STENTS PROVE TO BE SAFE, EFFECTIVE & LIFE PROLONGING

Clogged leg arteries, or peripheral arterial disease (PAD) affects up to 20% of Americans 65 or older.

William Julien, M.D., medical director of South Florida Vascular Associates says, “As the population ages that number is expected to climb even higher.” Aging, smoking, high blood pressure, diabetes, and obesity are the key risk factors.

PAD often occurs in the iliac arteries, the main arteries which carry blood from the abdominal aorta to the legs and feet. Often, the first sign of iliac artery disease is leg cramps or pain when walking. In its most severe form, PAD can cause painful sores on a patient’s toes and feet. If left untreated, the blood circulation to the lower extremities will diminish causing ulcers that can become dry, gray or black, and eventually gangrenous, which can lead to amputation of a limb.

67 year-old Frank Bartilotta was forced to retire from the grocery business, in part because of PAD. His quality of life was miserable and he was unable couldn’t do anything that required walking. He even had to sit in a chair to shower.

Unloading grocery trucks for years and smoking a pack of cigarettes a day took its toll. on Bartilotta. His walking capability was only a couple of minutes at the most.

His PAD was so severe, treatment required angioplasty and iliac stenting in both legs.


 “Treating PAD with stents is not new. We’ve been doing it more than 20 years, says Dr. Julien, but the technique and the stents are more durable and better constructed these days.”
Mounting research confirms iliac stenting is safe, highly effective and life  extending.

Nearly 100-percent of all patients with PAD can be successfully treated. The procedure, which takes roughly up to 90 minutes and is performed with local anesthesia, is fairly simple and similar to placing stents in clogged arteries in other parts of the body. Most patients are usually up on their feet roughly two to six hours after the procedure and can immediately go back to normal activities.

In Bartilotta’s case, the iliac stents originally put in place by another doctor were too small. Bartilotta was referred to Dr. Julien who fixed the problem by doing balloon angioplasty to open up the stents wider, replacing normal blood flow to his legs. And it worked!

Bartilotta  never thought he would be back to normal, but now he is able to do whatever he wants. He can walk a good 10-to-15 minutes at a time and it’s getting better all the time. Life is pretty close to back to normal. he even went on a cruise on the biggest ship in the world and was able to walk the entire length of the ship.Barlotta now swims again, goes to the gym, takes long walks and is able to resume his fulfilling active life as he once knew it.

If you have been diagnosed or suspect that PAD is your problem, take our survey to see if you are at risk and make an appointment at our Broward or Palm Beach office with one of our physicians to discuss the best treatment option for you.

Are You At Risk For Peripheral Artery Disease (PAD) ?

 According to the Society of Interventional Radiologists, peripheral arterial disease (PAD) affects an estimated 8 to 10 million people in the United States. Individuals with PAD are at greater risk for heart attack, stroke and loss of limbs, yet awareness among the general public and primary care physicians regarding diagnosis, treatment and prevention of this disease is extremely low. 

The most common symptom of PAD is painful cramping in the hips, thighs, or calves when walking, climbing stairs or exercising.

Get Tested for PAD If You
•    Are over age 50
•    Have a family history of vascular disease, such as PAD, aneurysm, heart attack or stroke
•    Have high cholesterol and/or high lipid blood test
•    Have diabetes
•    Have ever smoked or smoke now
•    Have an inactive lifestyle
•    Have a personal history of high blood pressure, heart disease, or other vascular disease
•    Have trouble walking that involves cramping or tiredness in the muscle with walking or exercising, which is relieved by resting
•    Have pain in the legs or feet that awaken you at night

We invite you to answer a few yes or no questions on our questionnaire to get a baseline indication whether you are at potential risk for peripheral artery disease.  Fill out your contact information and if your score indicates that you may be at risk please contact our office for a consultation with one of our board certified interventional radiologists.

Minimally Invasive Procedure Saves Limbs and Lives for Those Suffering From Peripheral Artery Disease

Peripheral Artery Disease(PAD) is the hardening or narrowing of the arteries in the leg caused by fatty deposits or calcium which accumulate in the blood vessels of the buttocks, legs, and feet blocking normal blood flow.


Early signs of PAD can include pain to the hips, legs, and feet during normal activities such as walking. When PAD advances, it can lead to Critical Limb Ischemia (CLI) which includes leg pain at rest, wounds that are slow to heal, and gangrene. This puts a patient at risk for amputation. Depending on the severity of PAD, it can be treated through lifestyle changes, medication, or minimally invasive procedures such as an atherectomy.


An atherectomy is a minimally invasive procedure that utilizes a catheter with a sharp blade on the end to remove plaque from a blood vessel. The catheter is inserted into the artery through a small puncture in the artery and is navigated under x-ray guidance. It is designed to pulverize the plaque and sands it into tiny particles that are washed away with the patient’s blood flow. By restoring blood flow in the legs, a significant outcome can be achieved for most patients. Interventional radiologists have been using minimally invasive atherectomy procedures for the treatment of PAD for several years, however the technology continues to improve allowing doctors to treat many more people. Atherectomy has been a breakthrough in the treatment of PAD and has proven to improve a patient’s quality of life by alleviating pain, enhancing mobility, re-establishing blood flow to non-healing wounds and reducing the number of amputations.


If you have been diagnosed with PAD there are many treatments that can help you regain your quality of life. If you have any questions or would like to schedule an appointment for a consultation with Dr. William Julien or Dr. Warren Swee.