Patient's Quality of Life Returns After Clinical Trial

February 23, 2015

Narrated animation of the procedure.

Nanostim™ leadless pacemaker.

Simply getting out of her chair was difficult for Marilyn Gould. She recently participated in a clinical trial for an innovative leadless pacemaker; now she has more energy and can move more freely than before.

In 2013, 69-year-old Gould, who struggles with a variety of ongoing health concerns, had a heart attack and stroke. She was diagnosed with bradycardia, otherwise known as a slow heart rate. To improve her condition, Gould had a temporary pacemaker implanted at another hospital. However, it did just the opposite.

“I could barely move because of the leads,” Gould said. “I ended up with a bad infection, had the pacemaker removed and was in the hospital for months recovering.”

Once she finally went home, she was still weak and her pulse rate continued to drop from the 50s to the 30s. Because of other health conditions, Gould was at higher risk for a traditional pacemaker. “My quality of life was terrible,” Gould said. “I was told I could live with low pulse, but I felt so bad.”

Janet Dietrich, Gould’s caregiver, spoke about her symptoms when her pulse was in the 30s. “She could hardly eat, couldn’t lift her arms up and couldn’t transition out of her wheelchair. Her pulse would drop every time she got up and her nose would go white while she was sitting in her chair. You could tell she wasn’t getting good circulation.”

Gould sought a second opinion at Mercy Clinic Heart and Vascular. She was warned against a traditional pacemaker, and offered an alternative - to be part of a clinical trial for the NanostimTM leadless pacemaker.

Mercy Hospital St. Louis is the first and only hospital in Missouri to implant the Nanostim™ leadless pacemaker as part of the LEADLESS II Clinical Trial. The device, smaller than an AAA battery and less than 10 percent the size of conventional pacemaker, is the world’s first retrievable, non-surgical pacing technology.

“The doctor told me about the bullet,” Gould recalled. “My family and I read over the booklet, but I was wary. I had just been in the hospital for four months and didn’t want to take any chances.” However, she just couldn’t stop thinking about it. “I kept reading over the information and just felt so terrible, I decided to give it a try.”

Gould had the leadless pacemaker implanted in January 2015. Developed for patients with bradycardia, the Nanostim device is designed to be placed directly in a patient’s heart without the visible lump, scar and insulated wires (called leads) required for conventional pacemakers. 

Gould started feeling better immediately after the leadless pacemaker was implanted and symptoms related to her bradycardia nearly disappeared. She said she has more energy, less shortness of breath, her lightheadedness went away and she no longer has to take blood pressure medication.

“I feel great; there’s no comparison,” Gould said. “Anyone considering it should go for it. The doctors have been really pleased, and so have I.”

Dietrich commented, “It’s been like night and day. Surgery is a risk no matter what, but not to have the recovery when you’re older is really important.”

For questions or to see if you qualify, call Mercy Cardiovascular Research at 314-251-3920. For more information about the Nanostim leadless pacemaker and the LEADLESS II Clinical trial, click here.

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