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May 5, 2011 (San Francisco, California) — Burgeoning acquaintance with an implantable cardioverter-defibrillator (ICD) that has an absolutely subcutaneous advance arrangement (S-ICD, Cameron Health, San Clemente, CA) continues to advance that it's as able at endlessly potentially baleful arrhythmias as a transvenous-lead ICD, but it's additionally highlighting some limitations to antithesis its actual attributes.
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In a 98-patient acquaintance from three centers in the Netherlands, appear actuality at the Heart Rhythm Society (HRS) 2011 Scientific Sessions, the accessory auspiciously concluded all 42 episodes of abiding and nonsustained ventricular tachycardia (VT) in the accomplice over an boilerplate of nine months [1].
Moreover, the arrangement is easier to implant than transvenous systems, as it doesn't crave vascular access, it seems to affectation little if any accident of cardiovascular complications, and it's so accessible to abolish that "a accepted practitioner could do it," Dr Lara Dabiri Abkenari (Erasmus Medical Center, Rotterdam, the Netherlands), who afterwards formally presented the new data, told heartwire .
In a development that some assemblage at the HRS sessions begin a little disquieting, bristles patients in the alternation developed cutaneous infections that were allegedly accessory related. Such infections with transvenous leads can be added serious, as they can accommodate sepsis or endocarditis; but their accident is far beneath than 5%.
Acknowledging that 98 patients is still a baby experience, Abkenari went as far in comparing the S-ICD to accepted transvenous-lead ICDs as to say that "it's a applicable alternative."
The device's primary limitation, she said, is that it can't accommodate connected pacing, although it can convention "backup" transthoracic pacing for 30 abnormal afterwards a shock. But the S-ICD isn't an advantage for patients who accept or who are at added accident of developing bradycardia or added accepted break for pacing. It additionally can't accommodate antitachycardia pacing (ATC) as an addition to shocks.
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"It won't alter transvenous systems; it's an addition for alleged patients. We use it in about 10% of our implants," Abkenari said. "We exclude patients who accept higher-degree [atrioventricular] AV block or any affectionate of appropriate bradycardia. And patients with nonsustained or abiding VT--they would apparently account from ATC and would not get the subcutaneous system. Additionally actual decompensated patients or those with a abeyant for resynchronization analysis in the approaching would not get it, either."
The S-ICD delivers shocks that are about four times as able as those from transvenous-lead systems, and currently its architect box is 30% larger, she said. The beyond admeasurement is in allotment to accommodate a higher-capacity battery, which makes its constancy aggressive with accepted devices.
Abkenari acknowledges that patients are generally taken ashamed by the device's size. "It's bulky, but nobody's banned it because of the bulkiness."
The device's architect "can" is built-in subcutaneously in the crabbed position, while the leads are threaded beneath the bark in a agreement agreed with X-rays; the action itself is not guided by fluoroscopy or added imaging.
More than 80% of the cohort, she said, accustomed the accessory afterwards it becoming CE mark approval in Europe. Those built-in with the S-ICD afore that point were amid those appear at aftermost year's HRS meeting, additionally covered by heartwire .
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Assigned to animadversion on Abkenari's academic presentation, Dr Bruce L Wilkoff (Cleveland Clinic, OH), who is the HRS president-elect, said the Dutch acquaintance exemplifies "what artlessly happens as you cycle out a technology." Unusual affiance conceivably approved in aboriginal series, with few patients, may not abide as acquaintance grows. "You alpha to accept it a little better, and you alpha to see some of the warts."
On the added hand, he acknowledged, fair appraisal of a new technology shouldn't be based alone on the ancient acquaintance with it or alone on the average experience. And the Dutch series, he seemed to imply, represents an average experience.
Of the 98 patients, 62 accustomed the accessory for primary prevention; 41% had ischemic cardiomyopathy. There were 14 episodes of nonsustained VT in bristles patients and 28 episodes of abiding VT in four patients. Eight patients accomplished 22 inappropriate shocks; in all cases, the botheration was "fixed" with a programming amend or by advance repositioning, according to Abkenari.
She said she isn't abiding why their amount of infection was so high. She speculated that the bristles patients who developed infections could accept been amid those built-in with the S-ICD instead of a transvenous-lead accessory because they were at added accident for infection: one of them was diabetic and addition had an advancing bark infection at the time of implantation, for example. For some of the group, she said, "we knew that if an infection did occur, there wouldn't be a accident for endocarditis or sepsis. It would aloof break skin-deep." Patients alleged for S-ICD therapy, she noted, wouldn't necessarily be acceptable candidates for transvenous-lead systems.
Wilkoff alleged the about 5% infection amount "disturbing," accustomed that there were hopes that infections "would be added calmly managed" with the subcutaneous-lead arrangement than with transvenous-lead systems. "Maybe there were beneath [lead] extractions, but absolutely there weren't beneath infections."
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He additionally bidding misgivings about the four patients in the alternation who accomplished 28 episodes of abiding VT that were brash by shocks. "It's adamantine to brainstorm that those patients couldn't accept benefited a little from antitachycardia pacing. Although I don't accept all the capacity [on the Dutch series], antitachycardia pacing may be an important basic to what's bare in a device."
Abkenari acicular out types of patients who assume decidedly ill-fitted to accepting an S-ICD rather than a transvenous-lead ICD. "People who accept had explants of transvenous systems due to advance fracture, for example, or who don't accept vascular access, those are actual nice patients for this."
Also: patients who appetite to be active. "We've had patients who accept absolutely begged for it." Some are golfers, she said, and "I accept a semiprofessional hockey amateur who aloof capital to accumulate arena hockey. A adolescent accommodating with a transvenous lead--hockey, golf? Not advised. There's abundant beneath limitation to your movements because it's absorbed to your thorax."
Neither Abkenari nor Wilkoff had disclosures.
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