Little Implant Makes Big Difference

A walk down the hall is no small step for Donna Byerley.

"I couldn't carry on a conversation. I would have to sit and rest to take a shower. Walking was almost impossible," she recalls

At 51-years old, the registered nurse was disabled with end-stage chronic obstructive pulmonary disease. Without a lung transplant, her doctor gave her six months to live.

"On days, I did run out of air," she said. "It was like drowning."

That's when Dr. William Leeds told her about the Emphasys VENT trial. It aims to see if implanting a special device, the size of a pencil eraser, can help patients like Donna catch the breath they've lost as COPD has literally dissolved the connective tissue in their lung.

"It would be like a balloon just overinflating - the lung turns into a balloon that overinflates," Dr. Leeds describes the problem. "If you try to blow more air into it, it's very difficult."

Doctors use a bronchoscope, sort of like a small telescope, to place the device into the affected lung passage. The device blocks air from going into that overinflated area of the lung, while still allowing gasses to escape. By blocking air from getting in, the volume of the lung will shrink.

Dr. Leeds says "that will allow the good lung underneath it to expand and take over the space."

The procedure is done under mild sedation, with no general anesthesia and no scalpel required. Because it's a trial, Dr. Leeds and the entire staff he's working with at Stormont-Vail, where he does the procedure, underwent special training to take part.

He says it's worth it.

"This is a spectacular technology," he said. "It's the first time that people with end-stage emphysema have something dramatic that can affect their lives."

Donna says she's proof. Two months after her implant, she needs just a fraction of the oxygen she used to. While it's not a cure, she's back at work, and back on her feet.

"It's just been a lifesaver," she said. "I have my life back."

To find out about the trials, call Veritas Clinical Specialties at (785) 234-5480.

WIBW Expanded Coverage
from www.emphasysmedical.com

Study Description: The VENT research study is being conducted to assess the safety and efficacy of the Emphasys Endobronchial Valve (EBV). Patients will be randomized to receive either standard optimal medical management (with pulmonary rehabilitation) (control group) or the Emphasys Endobronchial Valve and procedure (with pulmonary rehabilitation) (treatment group).

Treatment: The Emphasys Endobronchial procedure is performed bronchoscopically under routine anesthesia using the EBV implantable device.

Inclusions:
*Age: 40-75
*BMI<31.1 kg/m² (men) or, 32.3 kg/m² (women)
*FEV1 (must be less than 45% of predicted value)
*6MWT must be greater than or equal to 140 meters (you must be able to walk at least 140 meters without stopping)
*No smoking for past 4 months prior to initial interview and throughout the screening process

Exclusions include:
*FEV1 must be greater than 15% of predicted value
*Prior lung transplant, LVRS, lobectomy or other procedure requiring a median sternotomy
*Pulmonary nodule requiring surgery
*History of recurrent infections requiring hospitalization (more than 1 hospitalization due to a respiratory infection within the last year)
*More than 4 tablespoons (60ml) per day of sputum production
*Heart attack or congestive heart failure within the last 6 months
*Exercise related syncope (fainting)
*Other life threatening disease or condition that compromises survival during a 5 year period or interferes with follow-up assessments
*Enrollment in another clinical trial
*Unplanned significant weight loss
*Alpha-1 antitrypsin deficiency

Note: Patient must be willing and able to participate in a Pulmonary Rehabilitation throughout the duration of study participation (both in-home and therapist assisted sessions are required).


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