Matters of the Heart: A Mixed Bag of Valentine's Day Cardiograms

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

Originally Published February 2000

A sampling of recent heart-care news reveals a mélange of the predictable, the unexpected, and the downright bizarre.

With this issue due to arrive around Valentine's Day, I thought it appropriate to transmit a few myocardial missives—both heartening and disheartening—that have been in the news lately.

It appears that studies are continuing to support the observations of practitioners that "beating-heart" or "off-pump" coronary bypass surgery confers demonstrable benefits for patients. Results of the largest retrospective observational study to date of beating-heart cases showed a less than 1% incidence of stroke following surgery, a less than 15% incidence of postoperative atrial fibrillation, and an operative mortality rate of 1%. Multivessel grafting was required in the majority of the 1582 procedures reported from six medical centers, and was successfully performed using the beating-heart technique. All six of the lead surgeons in the study have steadily increased their percentage of beating-heart cases versus traditional coronary artery bypass grafting (CABG) over the last several years.

Although the study claims to draw no definitive conclusions about the ultimate safety or advantages of the off-pump procedure, one participating surgeon commented that "the size of the study seems to indicate that beating-heart surgery can be safely applied to a wide range of CABG patients, with early outcomes as good or better than those surgeries undertaken with the traditional approach."

The cases performed in the study were done using Medtronic's Octopus family of tissue stabilizers—instruments with maneuverable arms and suction pods that immobilize a portion or the heart during the operation. The company's name for the devices is certainly descriptive, though one wonders how patients would react to the image of slowly squeezing tentacles. The brand name chosen by rival Guidant for its own recently launched vacuum-assist stabilization system—the Vortex—is hardly more reassuring. Perhaps the two products could be combined: after we open your chest, you spin down the whirlpool, then the big mollusk grabs you . . .

Another recent development shows that while everyone may want a heart of gold, having one of silver might not be such a great idea. On January 21, St. Jude Medical announced that it had initiated a worldwide voluntary recall of all field inventory of heart valve replacement and repair products incorporating its proprietary silver-based Silzone coating on the sewing cuff fabric. The recall was ordered for what the company termed "an unacceptable level of product explants as a result of a specific postoperative complication known as paravalvular leak."

The leakage problems came to light in the wake of a large-scale, company-sponsored trial designed to evaluate the effectiveness of the antimicrobial coating in reducing the incidence of endocarditis. As it should, the randomized, prospective trial also captured other normally reported complications common to valve-replacement surgery, and the company acted promptly in issuing the recall, while emphasizing that the leaks were unrelated to the design, manufacture, or function of the valve mechanism itself.

Although the data were undoubtedly a rude shock to St. Jude, the episode is an example of institutional oversight procedures working as they were intended. Such was definitely not the case in a hospital in Australia, where an unfortunate heart-attack victim crawled back into his bed only to be bitten by a tiger snake—reputedly the world's fourth-most-venomous serpent. The luckless patient somehow survived both the clot and the unconventional anticoagulant. I suppose the hospital's quality department could claim that it managed to keep out snakes number one, two, and three . . .

Here's wishing you Cupid's arrows, not those of outrageous fortune . . .

Jon Katz
[email protected]

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