July 17th, 2014

SIMPLE Can Be Complicated


The two of us, Joe on the west side of the Atlantic and Johnny across the pond, have always differed in our opinions about routine intraoperative defibrillation testing (DT) of implantable cardioverter-defibrillators (ICDs). Finally, though, we have reached a consensus. In our opinion, results from the SIMPLE trial, reported at the Heart Rhythm Society meeting in May, settle the issue in favor of no DT. However, the SIMPLE findings now expose a 64,000-pound gorilla in the room that may limit the adoption of this strategy in the U.S.

The value of routine DT has been controversial. The vast majority of randomized trials that underpin ICD guidelines have used routine DT, but growing clinical experience suggests that eliminating its routine use is safe and effective. Proponents of each approach have held strong and passionate opinions, prompting a real difference in clinical practice patterns. Many physicians routinely perform DT, but many practitioners, especially outside the U.S., are abandoning the practice.

In the SIMPLE trial, 2500 patients undergoing initial ICD implantation in 18 countries were randomly assigned either to a strategy of intraoperative DT or no DT. A lack of DT was not associated either with greater mortality risk or with worse clinical outcomes. Very notably, the strategy of no DT was associated with fewer perioperative complications (3.0%, vs. 4.5% with testing; P=0.047).

We believe that these results conclusively show that abandoning routine DT is safe for the majority of patients undergoing ICD implantation. But time will tell whether the transatlantic debate is finally over. As with all practice-changing trials, various challenges hinder widespread dissemination and adoption of the results. This is particularly true of SIMPLE because the stakes of a failed shock are high.

With SIMPLE there is also an additional economic challenge that is unique to the U.S.: Intraoperative DT carries a reimbursement code that is separate and independent of the code for the ICD implant procedure itself. This could serve as a financial disincentive for abandoning routine DT.

In effect, the SIMPLE trial has put the spotlight on thorny questions that are not so simple after all:

  • To what degree will reimbursement rules impede adoption of SIMPLE’s results?
  • Will the Center for Medicare & Medicaid Services bundle ICD implantation with DT, to prevent reimbursement considerations from influencing medical decision making?

Share your thoughts about the SIMPLE dilemma here on CardioExchange.

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