CLEVELAND, Ohio — The Cleveland Clinic is one of more than two dozen hospitals in the United States and Europe treating patients suffering from severe emphysemawith a nonsurgical device designed to help them breathe more easily.So far, two patients at the Clinic have each undergone two procedures – the most recent one on April 29 – in which 10 tiny metal coils were implanted in each lung. Six other patients are currently being evaluated at the Clinic for the clinical trial, which has an overall target enrollment of 300 people.
The coils are made of nitinol, a type of metal commonly used in medical implants. Nitinol is a “shape-memory” material. That allows the coils to be stretched as they are inserted through either the mouth or nose, and then bounce back to their original shape.
The procedure to implant the coils lasts less than an hour.
Emphysema – a form of Chronic Obstructive Pulmonary Disease, or COPD — causes air to become trapped inside of the lungs, causing them to over-inflate. Patients with emphysema have difficulty expelling the air, which causes shortness of breath. Emphysema is chronic and causes irreversible damage to lung tissue.
The implanted coils compress the damaged tissue and restore elasticity in healthier tissue, letting other parts of the lung work more effectively.
Clinical trials of the Lung Volume Reduction Coils (also called RePneu Coils), made by California-based medical device company PneumRx, began in Europe in 2009. The trial opened in the U.S. in 2013.
Arthur Greiner of Lorain was diagnosed with emphysema in 1997. A former smoker, Greiner, 65, kicked a 40-year habit in 1998 and started exercising and taking medications.
Over time, however, he began getting weaker. In 2000, his doctor put him on oxygen at night to keep his heart from becoming overworked.
Three years ago, the same doctor broached the topic of a lung transplant to Greiner.
So far, though, his condition has not worsened enough to be placed on the transplant wait list, on which there are about 1,660 people. Those with other lung diseases such as idiopathic pulmonary fibrosis (a rare disease that causes thickening, stiffening and scarring of lung tissue) often receive higher priority.
Last fall, during one of his pulmonary rehabilitation sessions at Mercy Regional Medical Center in Lorain, a nurse told Greiner about a new clinical trial that had opened at the Clinic.
Not long afterward, Greiner had his first meeting with Dr. Atul Mehta, a pulmonologist with the Clinic’s Respiratory Institute. It was pure coincidence; a last-minute appointment change meant seeing Mehta, principal investigator of the trial, instead of his regular pulmonary physician.
Having successfully passed the required physical tests, Greiner had 10 coils implanted in his right lung on Dec. 17.
The first thing he noticed after coming out of the anesthesia was his breathing. He was able to take a deep breath without his stomach hurting.
“That was amazing,” he said.
Others noticed that he no longer looked ashen. The color in his face had returned. When he talked, he didn’t have to stop to take a breath after just a few words.
Over time, Greiner began to notice that he was able to walk farther, and faster, on the treadmill during his rehab sessions.
The day after Mehta placed coils in his left lung, Greiner noticed even more changes.
The simplest things that once were taxing on his body – walking up the stairs, taking a shower, getting dressed – were no longer difficult.
“I wasn’t out of breath,” Greiner said.
One of the biggest advantages to the coil procedure is that it is not as risky as surgery, Mehta said.
“In the past, surgery for emphysema – lung volume reduction surgery – would cut out 50 percent of both upper lobes in an attempt to reduce hyper-inflating,” he said. But the high rate of complication has caused patients and physicians alike to shy away from it, he said.
Studies of other surgical and non-surgical procedures have either failed or not shown enough improvement for patients.
While the coil procedure shows a lot of promise in improving a patient’s quality of life, it’s not a cure, Mehta said.
“This does not stop the progression of emphysema,” he said. “Requiring a lung transplantation is still possible.”
For Greiner, the coil implants have been a “magical opportunity” that has allowed him to enjoy being active with his 12-year-old son.
“My COPD will never get better, but at least I can stay consistent,” he said. “My goal is to prolong and postpone a transplant.”