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Concern Over Heart Devices Hindering National Study: Only One Patient From Heart Clinic Willing to Enroll in Experiment

Posted on: Monday, 8 May 2006, 06:04 CDT

By Jeremy Olson, Pioneer Press, St. Paul, Minn.

May 8--Safety concerns over locally made pacemakers and defibrillators appear to be slowing efforts by the St. Paul Heart Clinic to study whether a new implantable device can treat heart failure.

The clinic, adjacent to United Hospital, has contributed only one patient to a 418-person national study of the Optimizer III, which, when implanted, is supposed to strengthen a weak heartbeat. The experimental device gives off an electrical charge that is believed to draw in calcium, a mineral that encourages a stronger beat.

Sales of implantable cardiac devices have slowed in the past year after recalls and warnings issued on certain devices made by Guidant, Medtronic and St. Jude Medical. The struggles of the St. Paul study suggest that these warnings have affected research involving cardiac implants as well, though a researcher at the Mayo Clinic in Rochester believes the stringent standards of the Optimizer study are more to blame.

Until now, St. Paul Heart's Dr. Stuart Adler could recall few patients who declined to participate in studies that he recommended. But patients seem worried about receiving this experimental implant.

"If I'm already concerned about the stuff" that has met federal safety standards, patients tell him, "then how bad could the new stuff be?"

St. Paul doctors said it is challenging to enroll patients in the first place, because fewer than one in 10 patients with heart failure meet the criteria for the Optimizer study. Patients are excluded, for example, if their heart failure can be treated with biventricular pacemakers, which synchronize the lower chambers of the heart when they aren't pumping in unison.

Those pacemakers are suitable for patients whose hearts experience too much down time between beats. The Optimizer doesn't affect the pace of a heartbeat, so it isn't being tested on patients with that problem. The device appears suitable for patients whose hearts are beating at an acceptable pace but aren't squeezing hard enough to pump an adequate supply of blood to the body.

The selective nature of this study is like "threading a needle," said Dr. Robert Rea of the Mayo Clinic, which has enrolled three patients.

Heart failure's primary symptoms include fatigue, breathlessness and a chronic cough. In earlier testing in Europe, the Optimizer showed an ability to reduce these symptoms and even reverse heart failure, said Omid Souresrafil of Impulse Dynamics, the company that makes the device. The company's efforts are largely funded by Johnson & Johnson.

If U.S. studies can reproduce these results, Souresrafil believes the Optimizer can gain federal approval within two years. He doubts the devices will ever be sold on their own but will instead be incorporated into existing cardiac implants sold by other companies.

Souresrafil said the stringent standards exist in all 50 sites taking part in the U.S. study. He believes the recall news is having a greater effect in the Twin Cities, which is home to Medtronic and St. Jude and to Guidant's cardiac rhythm management division (now part of Boston Scientific).

"Patients in Minnesota are a lot more aware because Minnesota is the medical alley," he said. "The news gets amplified a lot more here than it does in other states."

Jeremy Olson can be reached at jolson@pioneerpress.com or 651-228-5583.

FYI

St. Paul Heart Clinic's 24-hour research hot line is 651-726-2777. The study of the Optimizer III device is referred to as Fix-HF. See the clinic's Web site at www.stphc.com for more information on this or other clinical trials.

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Copyright (c) 2006, Pioneer Press, St. Paul, Minn.

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Source: Saint Paul Pioneer Press (St. Paul, Minn.)

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