Medical Device Daily Washington Editor

WASHINGTON – Fistulas that occur during radio frequency (RF) ablation to treat atrial fibrillation are anything but common, but are deadly more often than not when they do occur. One team at the University of Pennsylvania Hospital (UPH; Philadelphia) proposes that echo-cardiography and a sharp pair of eyes can reduce the incidence of this condition, but the idea is not well tested and other ablation methods could eventually replace RF ablation, potentially rendering the question moot.

These adhesions are typically due to damage to one or more organs and are seen in a number of areas of the body. However, a fistula between the heart and the esophagus as small as 1 mm in size can trigger fever and esophageal hemorrhage even in patients who, with the exception of their fibrillation, are healthy. According to at least one researcher at the Johns Hopkins University School of Medicine (Baltimore), the “resultant mortality [is] in excess of 75%.”

The team at UPH approached the problem by using intracardiac echocardiography (ICE) to keep tabs on fistula formation, and their results are included in the September edition of Heart Rhythm, a publication of the Heart Rhythm Society (HRS; Washington).

In that article, Jian-Fang Ren, MD; Francis Marchlinski, MD, and several others at UPH reviewed existing ICE scans from 79 patients and tracked perioperatively another 73 patients and concluded that by watching for the development of fistulas while operating, a surgeon can proactively shorten the duration and reduce level of the RF energy and that as a result, “lesion size can be controlled and limited to the left atrium posterior wall.”

The unexpected death of a 47-year-old patient prompted the UPH doctors to find a way to prevent fistulas. The woman had a history of Crohn's disease, which can cause inflammation of the esophagus in addition to the rest of the gastrointestinal tract. The procedure “was uneventful and well tolerated,” and an episode of post-surgical pain on the second day following the procedure was successfully treated with non-steroidal anti-inflammatories.

Two weeks later, the patient was readmitted with a tear in the esophagus at the junction with the stomach as well as water and air in the skull, the origins of which were not explained. The woman's circulatory system collapsed and she died before physicians could intervene.

The UPH team says that on ICE scans, fistula formation is preceded by the appearance of “accelerated bubble formation and a strong, bright echodensity.” By keeping an eye on the condition of the tissue surrounding the ablation site, a surgeon can modify the treatment and “prevent intramural superheating and sudden 'popping' since the popping results in crater-like lesions” that can lead to the perforations that are the source of fistulas.

The article notes that “a reduction in power from 70 to 50 watts and duration from 60 to 30 seconds were the primary changes that resulted in a dramatic reduction in depth of RF lesions depicted on echo imaging,” but added that real-time monitoring for morphological changes via ICE is more effective than “standard approaches to power delivery and monitoring.”

However, the UP team acknowledged that “because of the low incidence of esophageal fistula formation, it is difficult to be certain that our ablation delivery strategies will completely eliminate the risk.”

In an editorial appearing in the same edition of Heart Rhythm, Hugh Calkins, MD, director of the electrophysiology lab at Johns Hopkins, congratulates the authors “for this excellent contribution to the literature.” However, Caulkins seconds one of the points made by Jan, et al., on the rarity of the condition, and insists that, as a consequence, the inferential power of a study of such small numbers “is hardly compelling.”

Caulkins makes note of a paper by Pappone, et al., of San Raffaele University Hospital (Milan, Italy), that “reported only one patient with an atrial esophageal fistula among more than 5,000 procedures.” The Italian team evidently obtained this outcome by repositioning the ablation catheter “every 10 to 20 seconds rather than delivering a prolonged 60-second application of RF energy at a single ablation site.” The Hopkins physician also reminds the reader that other procedures, such as cryoablation, might reduce or eliminate the fistula problem altogether. He closes by noting that perioperative ICE monitoring could yet prove a vital tool, but insists that “the jury is still out.”

AAH raids rival association

The metropolitan Washington area is well known as a hotbed of intrigues, even for the hundreds of association that make their homes in the area. This includes a series of ongoing recruiting wars that facilitates the job-hopping that is characteristic of career-minded association executives.

Thus it was no surprise when the American Association for Homecare (AAH; Alexandria, Virginia) announced Monday that Tyler Wilson will take the offices of president and CEO of the association on Sept. 18. The 3,000-plus member association plucked Wilson from a smaller rival also located in Alexandria, the American Orthotic and Prosthetic Association (AOPA), which has nearly 2,000 members.

“We are pleased to bring such a veteran of the Washington association world on board,” said Tom Ryan, the board chairman of AAH and CEO of Homecare Concepts (Farmingdale, New York). Wilson spent six years as the executive director at AOPA.

According to an AAH press release, Wilson's r sum lists a stint at the U.S. Chamber of Commerce (Washington) as counsel for legal and regulatory affairs. He migrated to the Automotive Aftermarket Industry Association (Bethesda, Maryland), where he rose to the position of vice president.

Wilson said that he looks forward to zeroing in on “areas where we can better serve our members and build unity in the industry in these critical times.”

He added, “I look forward to leading AA Homecare and its members as the industry tackles critical issues with one voice.”