In The Deep Freeze - Genesis Participates in Clinical Trial to Treat Atrial Fibrillation    (Posted 5/30/06)

Joe Carstensen's heart was sending him a distress signal.  There would be a few rapid beats, a few slower beats, and then a few seconds of no beats at all.  

"It was like Morse Code.  There would be beats at different speeds, and then nothing," explained the 57-year-old Carstensen.  "I couldn't exercise like other people because my heart rate was always high.  I would get so tired if I tried to do anything strenuous."

Carstensen is one of 2.3 million Americans who experience cardiac arrhythmias, or irregular heartbeats. 

For some patients with cardiac arrhythmias, medication is effective.  Pacemakers are another option but patients who have the devices implanted often still require medication.  Catheter ablation procedures developed in recent years are another accepted and successful treatment. 

In his meeting with cardiologist Michael Giudici, M.D., of Cardiovascular Medicine, P.C. of Davenport, Carstensen heard about another alternative - cryoablation to treat atrial fibrillation.  

On April 25, 2006, Carstensen became part of a clinical trial to have his arrhythmia treated by cryoablation, or freezing of tissue.  Dr. Giudici performed the first-in-the-region procedure at Genesis Medical Center, Davenport. 

Dr. Giudici and Genesis are participating in a clinical trial sponsored by California-based CryoCor.  CryoCor is a company marketing the equipment necessary for cardiac cryoablation procedures. 

The patented system available from CryoCor is approved in Europe, where it is commercially available for use in treating atrial fibrillation, atrial flutter and other supraventricular tachycardias.  

Giudici: Safe and Effective Procedure
"Cryoablation is considered to be an improvement because of safety and efficacy," said Dr. Giudici, who specializes in the treatment of abnormal heart rhythms.  "Catheter ablation for atrial fibrillation is a procedure that, in the best of hands, is 80 percent effective.  We would like to be at 100 percent effectiveness, which is why the cryoablation is being tested. 

"Any tool that can take care of a condition that is miserable for the people who have it is worth considering.  People are looking for a permanent cure that is safe."  

Catheter ablation uses radiofrequency to burn, or cauterize, the tissue areas that are generating the irregular heartbeat.  The hot-tip catheter procedure has been available from Genesis Medical Center since 2004.  

The cryoablation technique uses a cold-tip cardiac catheter that can freeze at temperatures as cold as -130 F.  The tool is used to repair the abnormal electrical signals causing the arrhythmia without damaging surrounding tissue. 

"The problem with the radiofrequency procedure is that patients can end up with scarred or blocked veins," Dr. Giudici added.  "Using cryoablation is potentially safer for the patient, although the actual procedure is the same with both catheters.  It's the same procedure, but with a different, potentially better, tool.  

"The three main differences between the cryo and radiofrequency are that cryo penetrates deeper and can result in a deeper, larger lesion; cryo covers a larger area so there are fewer and fewer gaps; cryo doesn't damage or scar veins."  

Carstensen, the owner of a Clinton, Iowa, real estate business, has been happy with the results.  He was back at work quickly and has noticed improved stamina. 

The messages, or beats, from his heart are much more normal. 

"It went very well.  I went home after the procedure, took the next day off, then returned to work the next day," said Carstensen.  "When I told people about my arrhythmia, I kept hearing that I should talk with Dr. Giudici; that he is the best around."  

"When Dr. Giudici first talked about this procedure, my wife and I went home and did our own research on the computer.  We thought the procedure looked effective, but without some of the complications.  We also found out that the procedure had been available in Europe with good results."  

Not for Everyone
Over the past two years, Carstensen's symptoms were severe enough that during an executive physical at the Mayo Clinic in Rochester, Minn., he was hospitalized to undergo treatment to regulate his heartbeat.  He says all of the symptoms he experienced are now gone. 

"I'm doing well and feeling a lot better," Carstensen said. 

Dr. Giudici, a member of the Genesis Heart Institute, emphasized that the procedure will not match every patient's needs.  He said some patients may not be bothered enough by the symptoms to be candidates for the procedure and others may have a problem that is more severe and would not be best treated by cryoablation. 

"But for a lot of patients who are miserable because of their arrhythmia, this may be the best option we've found so far," Giudici said. 

In 2005, Dr. Giudici was selected as one of the top cardiologists in the country by a group called Best Doctors.  He has participated in research and development of numerous devices and techniques using pacemakers.  He is the author of more than 150 articles and abstracts and has presented his research at national and international conferences. 

Cryoablation for atrial fibrillation is available as an FDA-approved clinical trial sponsored by CryoCor. 

- Story by Craig Cooper, Genesis 

More About Atrial Fibrillation
Atrial fibrillation is by far the most commonly occurring cardiac arrhythmia affecting more than 23 million people in the U.S. each year. 

Atrial fibrillation causes the upper chambers of the heart (atria) to beat at an irregular rate and in an irregular rhythm.  This chaotic activity interrupts normal blood flow; predisposes the heart to the formation f blood clots; and results in a six times increase in stroke and a two times increase in mortality.  Over 80,000 strokes annually are causes by atrial fibrillation.  Each year, atrial fibrillation strikes more people than Parkinson's disease, epilepsy, and Alzheimer's disease combined.  

Patients with atrial fibrillation report symptoms, such as heart palpitations (a racing heart), fatigue, weakness, shortness of breath, chest pain, and light-headedness.  The current standard of care in the treatment of atrial fibrillation is life-long drug therapy - typically agents used in the attempt to restore the heart to its normal rate and rhythm, and blood thinners to prevent blood clot formation.  Unfortunately these drugs do not cure atrial fibrillation, and they have sometimes severe side effects which include arrhythmias, blindness, depression, impotence, lung toxicity (pulmonary fibrosis), skin discoloration, hemorrhage, liver damage, thyroid damage, and even death. 

Since episodes of atrial fibrillation are unpredictable, patients will often avoid travel, stop exercise, and shun visits with family and friends.  This loss of quality of life affects not only atrial fibrillation patients, but their family and friends as well.