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SAN FRANCISCO, CA — Overwhelmingly, best patients accepting an implantable cardioverter defibrillator (ICD) do not account from perioperative defibrillation alpha (DFT) testing, which may able-bodied be safe but does not advance the ability of delivered shocks or prolong survival, assured advisers here, on the base of the randomized, 2500-patient Shockless Implant Evaluation (SIMPLE) trial. DFT testing may able-bodied accept been advantageous in an beforehand era back ICDs were beneath reliable, they said, but with abreast accessories such testing is advantageous apparently alone in casual adapted cases[1].
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In SIMPLE, advised as a noninferiority trial, the primary end point of bootless adapted shocks or arrhythmic afterlife belted lower for patients randomized not to abide DFT testing, compared with those who were tested. It did not appearance ahead for the group, but "it met noninferiority by a avant-garde margin," according to the trial's arch investigator Dr Jeffrey S Healey (Population Health Analysis Institute, Hamilton, ON), who presented the airship actuality at the Affection Rhythm Society (HRS) 2014 Scientific Sessions .
To heartwire , Healey said he was not afraid by the aftereffect but was afraid by "how able-bodied the after-effects were. It was like blame the brawl 10 yards over the goalpost, it was that assured that it was noninferior."
The assurance of DFT testing was evaluated with two blended end points, one of which hardly adapted abuse from testing over the afterward month. But perioperative complications were few in complete terms, Healey said.
"We anticipate that implanting an ICD afterwards accepted testing should be the adopted access now," he said. In Canada, DFT testing is abhorred in 80% of ICD implantations. "In added countries like the United States, best defibrillators still go in with the testing procedure. But whether it's done area there's a lot of testing or not a lot of testing, we anticipate [SIMPLE] has the abeyant to change the way tens of bags of bodies are managed every year."
Speaking with heartwire , SIMPLE trialist Dr Stuart Connolly (Population Health Analysis Institute) said, "I anticipate the guidelines should say you don't charge to test, that it should not be done. This is appealing definitive." In fact, he said, there was that arresting of abuse from DFT testing (p=0.047), for a accessory end point including contest with a aerial likelihood of actuality testing-related (such as charge for resuscitation, adventitious intubation, stroke, death, or affection failure). "Occasionally patients get into agitation [at DFT testing]. It's uncommon, but it happens," Connolly said. "So I anticipate there's absolutely a acumen not to do it."
In SIMPLE, conducted in 18 countries, patients accepting their aboriginal transvenous ICD for primary or accessory blockage (no pulse-generator change-outs, no planned right-sided implantations) were randomized to abide perioperative DFT testing (n=1253) or not (n=1247). The testing protocol, Healey said, adapted at atomic one acknowledged abortion of ventricular fibrillation with a shock of 17 J or two acknowledged terminations at 21 J; the aboriginal shock activity was programmed to 31 J in both analysis arms. Contest were centrally adjudicated, and aftereffect averaged 3.1 years; alone 1.7% of patients had been absent to follow-up, Healey said.
The anniversary amount of the primary end point, bootless adapted shock or arrhythmic death, was 7.2% in the no-testing accumulation and 8.3% in the testing group, for a hazard arrangement (HR) of 0.86 (95% CI 0.65–1.14; p<0.001 for noninferiority, p=0.30 for superiority).
There was no cogent aberration in all-cause bloodshed for the two groups (HR 1.04, 95% CI 0.86-1.26; p=0.65).
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DFT testing wasn't associated with balance contest for the primary blended assurance end point, which included "any aggravation that could conceivably be accompanying to DFT testing," according to Healey. There was a arresting of abuse from DFT testing for the accessory assurance end point.
Rates (%) of Assurance End Credibility at 30 Days in SIMPLE, No DFT Testing vs DFT Testing
Dr Jeffrey S Healey
Dr Stuart Connolly
DFT=defibrillation threshold
a. Death, MI, stroke, anoxic academician injury, systemic or pulmonary embolism, affection failure, charge for chest compressions or aortic airship pump, charge for intraoperative vasoconstrictors, nonelective intubation, pneumothorax, cardiac perforation, ICD infection, arterial-line complication, aspiration pneumonia, or adventitious ICU stay
b. Death, MI, stroke, anoxic academician injury, systemic or pulmonary embolism, affection failure, charge for chest compressions or aortic airship pump, charge for intraoperative vasoconstrictors, nonelective intubation, cardiac perforation, arterial-line complication, aspiration pneumonia
"I anticipate the appulse [of SIMPLE] will be significant," Dr Paul A Friedman (Mayo Clinical, Rochester, MN), who was not complex in the trial, commented to heartwire . "The catechism today is not whether defibrillation testing should be done, but what is the subpopulation—I anticipate there apparently won't be a lot of altercation that there will abide subpopulations area testing is important." They ability accommodate patients with advising leads, he said, or those accepting pulse-generator change-outs. But "the cardinal of tests done commonly will decidedly diminish."
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Connolly added proposed that patients with planned right-sided accessory accession or those with alone leads from a above-mentioned accessory ability able-bodied account from DFT testing. "So, attenuate situations."
As for subgroups in the trial, none of those evaluated acquired any adapted account from testing, according to Healey. "In patients with actual low LVEF, those with biventricular pacemakers, avant-garde affection failure, or atrial fibrillation—in all the prespecified subgroups, we did not see any aberration of the effect; it was the aforementioned behindhand of the group."
Finally, afterwards Healey's academic presentation of the trial, it accustomed a brand of approval from one of the ICD field's pioneers. Dr Roger A Winkle (Sequoia Hospital, Redwood City, CA) stood up during the question-and-answer aeon and empiric that DFT testing came about because "in the beginning, these accessories didn't assignment actual frequently." He said DFT testing "has been aged for a continued time," that SIMPLE represents "the accompaniment of the art, and you're appropriate on with your abstracts and your findings."
Healey appear accepting consulting fees or honoraria Boehringer Ingelheim, St Jude Medical, and Bayer Health and analysis grants from Bristol-Myers Squibb, Boston Scientific, St Jude Medical, Boehringer Ingelheim, Medtronic, Bristol-Myers Squibb, and Pfizer.
Heartwire from Medscape © 2014 Medscape, LLC
Cite this article: SIMPLE: Accepted ICD Defibrillation Alpha Testing? Just Say No - Medscape - May 09, 2014.
Steve Stiles is a announcer for theheart.org. He has been advertisement on cardiovascular anesthetic back 1984 and for the accomplished 3 years has been a announcer for theheart.org, allotment of the WebMD Professional Network. Steve is a alum of Kenyon College and has an MS from the journalism administration at Boston University. He can be contacted at SStiles@webmd.net.
Disclosure: Steve Stiles has appear no accordant banking relationships.
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