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    • First Spinal Cord Stimulator Implant

First Spinal Cord Stimulator Implant

St. Luke's Neurosurgeon Performs Region's First Spinal Cord Stimulator Implant on December 14

Patient Lauds Results to Help Manage Chronic Pain


Dr. Steven Falowski greets Jeff Hardick
with his wife, Terri and his daughter,

Bethlehem, PA (1/5/2012) – Jeff Hardick lay in bed, staring at the ceiling of his bedroom. He had spent three years this way -- three long years engulfed in the despair that only someone in chronic, excruciating pain can feel.

He had no hope. He only felt pain - the physical pain that coursed down his spine and from which he had no relief, no matter what position he lay, and the mental anguish from living this way after having a full, active life for 47 years. Waking up was disappointing. He took 270 pain pills a month. He passed out once or twice a week when he tried to do simple tasks. His wife or daughter would come home to find him bloody and passed out on top of a shattered water glass or to find him at the bottom of the stairs with cuts on his face, gashes on his head and bruises on his arms. He threw up regularly from the pain and from the medications.

"The pain overrode my life," Jeff said. "That’s all I thought about. I didn’t really hear when people spoke to me. All I could hear was the pain. It controlled me – I didn’t control it."

Jeff’s back issues started in 2001 while he was bending sheet metal on a hydraulic press, and he felt a pop in his back. The pain injection at the hospital helped, and he returned to work six weeks later, managing his pain with over the counter medication. Two years later, the pain worsened, and he underwent surgery to remove the bulging disk. For the next four years, he continued to work until 2007 when another disk ruptured. He underwent another surgery, where his spine was fused with metal bars. The pain was constant, but manageable.

But nearly eight years after his first injury, Jeff was lifting heavy sheet metal when he felt the sharpest pain he ever experienced and passed out. After spending two weeks in the hospital and seeing a multitude of specialists, he was told that he would probably be spending the rest of his life in a wheelchair and on heavy pain medications. The couple sought second, third and fourth opinions, only to be told the same sobering news. Depression became his only companion, as he continued to withdraw. "I had given up," Jeff said. His wife Terri and daughter Nicole had not. They struggled to get him to get out to dinner or to talk with friends. He was not interested. All he heard and felt was screaming pain.

A Chance Meeting Changes Everything

While at the grocery store one day, Jeff and Terri ran into a former coworker of Jeff’s who observed him in walking with a cane and hunched over in pain. She told the couple about an article she read about pain management through spinal cord implants and sent Jeff the article about the FDA approval of Medtronic, the medical device company that researched and developed the technology. After Jeff’s inquiry, Jeff’s pain management physician put Jeff in touch with St. Luke’s neurosurgeon Dr. Steven Falowski.

NeuroStimulator Surgery and Technology

Terri encouraged Jeff to pursue the neurostimulation surgery. Jeff was apathetic but with Terri’s encouragement went to see Dr. Falowski, the region’s only fellowship-trained neurosurgeon specializing in functional neurosurgery in the Lehigh Valley.

"Jeff was a good candidate for this procedure," explained Dr. Falowski. "His pain was no longer managed by medications and his once-active life was impacted severely by the pain he experienced."

The procedure involves an electrode implanted in the patient’s back near the source of the nerve pain and a movement sensor under the skin of the buttock. The implanted electrode produces mild electrical impulses to block the transmission of pain from the nerve endings before the pain impulse reaches the brain. The surgery is used in conjunction with pain medication for some people, but some patients are able to stop all medications.

The RestoreSensor Neurostimulator® device by Medtronic that Dr. Fawloski uses was approved by the FDA in the middle of November, 2011. St. Luke’s was one of thirteen original sites selected throughout the country to receive the first devices immediately following FDA approval.

Although the technology has been around for years (the first type was FDA approved in 1986), the level electrical impulses had to be manually changed for the differing levels of pain patients would feel when they moved. For example, if a patient felt more pain during sitting than lying down, the patient would have to manually change the amount of stimulation when they sat. Every time a patient moved, the patient would have to adjust the level of therapy.

The disadvantage of the former technology, said Dr. Falowski, is that some patients would not change the level of therapy based on their movement, which would under-stimulate the nerves during some movements and over-stimulate the nerves during others. This can result in what patients describe as a jolt during certain movements.

The newly-approved RestoreSensor Neurostimulator® has a sensor/battery pack that is implanted in the gluteus muscle in the buttock that senses the patient movement and automatically adjusts the appropriate amount of stimulation for the level of pain experienced by the patient. Simply, the device senses when the patient is standing, sitting, lying down, or moving left or right and adjusts the level of therapy as needed. The technology uses an accelerometer, which is the same technology used by smart phones and tablets to adjust images from vertical to horizontal.

"This is the first implantable device that actually can learn what an individual patient’s body tolerates and prefers - then can automatically change the therapy levels based on the body’s reaction," said Dr. Falowski. Dr. Falowski has performed nearly 250 of the neurostimulators placement surgeries – some with the patients asleep and some awake. He has co-published a paper "Awake vs. Asleep Placement of Spinal Cord Stimulators: A Cohort Analysis of Complications Associated with Placement" that was published in the January 2011 edition of Neuromodulation: Technology at the Neural Interface medical journal.

Dr. Falowski stressed that the procedure is not a "last resort" for patients – and recommends patients try it when they are not able to relieve pain with anti-inflammatories, physical therapy, injections and/or pain medications. In fact, he recommends patients undergo the procedure earlier in the disease state. If someone has suffered chronic pain for more than 6 months, the patient may be considered for the procedure.

"This surgery has been proved safe and effective through the clinical trials that lead to the FDA approval," said Dr. Falowski. The procedure is covered by most insurances.

Two-Day Trial

Patients who are considering the neurostimulation surgery participate in a trial with a stimulator that is connected to the patient by pain management physicians in an outpatient procedure. The trial determines which patients are appropriate candidates for the actual permanent surgery with Dr. Falowski. During the trial, the patient manually adjusts the amount of therapy.

Patients who experience at least a 50% reduction in pain during the trial and who find the "warm water" feeling of the nerve stimulation pleasant are good candidates for surgery, said Dr. Falowski. During the trial, Jeff’s pain was reduced to such a low level that he felt even more hope of success.

After two days trying the technology, Jeff was ready to commit to the surgery.

Surgery Day – December 14, 2011

Prior to surgery, Jeff told Dr. Falowski, "Let’s rock and roll," For the first time in three years, he had a glimmer of hope.

Dr. Falowski performed the surgery on December 14, 2011 – the first time a neurostimulator device with an automatic position adjustment was implanted in the Lehigh Valley and in Northeastern Pennsylvania and the second such procedure in the country. (The first surgery was performed in Virginia two days prior.)

Jeff’s surgery lasted almost two hours, a typical time frame for this procedure, said Dr. Falowski. After the surgery, the patient goes home the same day and is restricted for 6 – 8 weeks with no bending, reaching or lifting so that the location of the electrode on the spinal cord is not changed. Once the surgeon is assured the electrode has remained in the optimal position to block as much pain transmission as possible, the patient is cleared for activity.

During the first four weeks, the patient manually manages the amount of stimulation until the battery pack heals in place. The patient returns to the surgeon afterwards to have the new movement sensor technology turned on.

Although the surgery and implant is not a cure for Jeff’s back problems, the surgery can control the pain that debilitated Jeff’s daily activities, allows him to stop taking medication and provides better quality of life, said Dr. Falowski, since pain impacts driving, working, thinking and may create fatigue and cause depression for patients.

The newly-FDA-approved technology has had an 88% patient satisfaction response – nearly unheard of in the medical field, according to Dr. Falowski. The satisfaction rate means that 88 out of 100 patients said that they could not live without the technology.

Three Weeks Postsurgery

Three weeks later, Jeff and Terri’s life has changed. The medication and pain fog has cleared, and Jeff now looks forward to waking up.

"I love my life now," Jeff said. "Terri told me I wake up with a smile. When the implant was turned on, it was like a light switch – the pain went away. We got a Christmas miracle!"

Friends and family remarked over the holidays about how Jeff had changed in a few short weeks. Out of the wheelchair, Jeff was proud he could stand straight again. "My family and friends said 'We forgot how tall you are'," said the six-footer. “And we all cried, because after being hunched over from the pain and in the wheelchair for so long, I had forgotten, too.”

"My family sacrificed a lot – we lost a lot of time the past three years. We didn’t take vacation to the beach or go anywhere. I couldn’t, it hurt too much and if I went out to eat, I would have to be slumped in a wheelchair."

Jeff has stopped taking pain medication and the anti-depressant prescribed for him. He can stand up from sitting or lying by himself – no assistance needed and no shooting pain. He has not passed out, fallen or thrown up in three weeks. He wants to lose the 30 pounds he gained while bed-ridden and is setting small goals for himself.

"When I’m cleared for activity, I am going to do physical therapy – I want to get back in shape so I can walk the beach with my wife this summer and hike some trails in Jim Thorpe in the fall," he said. "The last three weeks, my wife has had to hold me back from doing too much because I have a few more weeks of limited activity. But I can’t wait to get started!"

Learn more about St. Luke’s Neurosurgery.

Functional Neurosurgery:

Functional neurosurgery is a subspecialty of neurosurgery. Functional neurosurgeons study and treat conditions where central nervous system (brain and spinal cord) function is abnormal although the structure or anatomy is normal. Conditions include movement disorders (like Parkinson’s disease and tremors), chronic pain and epilepsy. Dr. Falowski completed a neurosurgery residency and a functional neurosurgery fellowship. He is the only fellowship-trained functional neurosurgeon in the Lehigh Valley. He is a faculty member of the North American Neuromodulation Society and trains other neurosurgeons to perform the procedures.

According to Dr. Falowski, fewer than ten functional neurosurgeons to complete fellowship training annually in the United States.