Background

The patient is a 17-year-old male diagnosed with ventricular preexcitation since the age of 9. Initially he complained of only intermittent palpitations, but more recently demonstrated an adenosine-sensitive sustained supraventricular tachycardia (SVT). Although he was well-controlled on beta-blocker therapy, he was a competitive swimmer and preferred nonpharmacologic curative therapy.

He underwent diagnostic electrophysiology testing eight months prior to the curative ablation. This evaluation diagnosed a manifest posteroseptal pathway (Figure 1) and a concealed right free wall pathway. Unfortunately, ablation attempts were unsuccessful. Repeat procedure six months later was also unsuccessful, despite the use of a unidirectional cooled tipped catheter.

Eight months after the initial procedure, he presented for repeat electrophysiology testing and ablation at our institution.

Electrophysiology Study

Summary of Recent Advisories

Medtronic, Inc. (Minneapolis, MN) issued a physician advisory letter in February 2005 regarding an increased risk of sudden battery failure in some of its ICDs in the Marquis family. This involved a shorting mechanism attributed to a specific battery design. Some devices were explanted, but the majority was followed closely. The initial response of the medical community was to exchange these devices; however, more patients were likely harmed by the explantation approach than helped by it. In our practice, two patients were referred from other centers for device infection after generator exchanges, for ICD and lead removal. A follow-up analysis showed an anode grid short rate of 0.01-0.07% during the first half of battery life.

To understand where risk management is going, we need to appreciate its past. Historically, risk identification/ management was instituted in the corporate world in the 1940 s as a quality control technique. In the 1970 s, the nation faced a medical malpractice crisis, with a dramatic rise in the number of malpractice claims being filed and given staggering jury awards. The large awards affected professional liability insurance markets. Faced with potential bankruptcy, insurers either withdrew from the market or demanded heightened accountability in reporting and managing risks from insureds. Healthcare providers responded by creating coverage options and initiating programs to identify and control professional liability risks. Risk management efforts focused on retrospective reviews of incidents, loss reduction, and claims management.