The so-called "leadless" implantable cardiac defibrillator made by Cameron Health made its debut at the Heart Rhythm Society’s annual meeting this week, generating considerable excitement among physicians here in Boston.
Two studies presented at the conference, 1 sponsored by Cameron Health to back its investigational device exemption application with the FDA and a 2nd, "real-world" evaluation of European patients, both showed that the subcutaneous ICD has comparable safety and effectiveness rates as more traditional transvenous ICDs.
Results from a study presented at the HRS conference yesterday found the device safe and effective for treating patients with life-threatening ventricular arrhythmias.
"This has been an exciting study," co-author Dr. Martin Burke told reporters. "It’s a joy to work with [the S-ICD] and [the patients] all love it. … This particular trial demonstrated that both [safety and efficacy] endpoints were met."
The S-ICD successfully converted 100% of the ventricular fibrillations in the 304 patients who completed the trial. The rate of major complications was 4.4% at 30 days and 7.9% after 6 months. Twenty-three patients, or 7.2%, needed repeat surgeries to correct problems such as electrode movement, device movement or discomfort. Four devices (1.2%) were pulled for infections and 2 (0.6%) underwent "premature battery depletion." There were 8 deaths (2.5%), according to the researchers, with 1 associated with an "appropriate" shock and another unable to be defined because the device wasn’t available to examine.
The European "Effortless" S-ICD registry trial followed 230 patients for 5 years, finding that the device "is functioning appropriately and is emerging as a viable option for a significant proportion of standard ICD patients."
If that holds true, the S-ICD could be the game-changer Burke and Cameron Health CEO Kevin Hykes believe it to be.
"I fail to see any niche for this device. It’s a broad spectrum device that’s actually beginning to expand, not the indications, but the application of ICDS to indicated populations that currently don’t get them," Burke told MassDevice.com yesterday afternoon in Beantown. "This is a huge issue. We need to do it. There’s a person dying every 13 seconds from sudden card death. Fifty percent of them know they have heart disease, but they don’t have a defibrillator because their doctors are afraid of putting a transvenous lead system in them – or they’re afraid to get a lead system. We need to change that paradigm and make [ICDs] an available system."
"It’s a very interesting device. It’s very nice. As a device, it seems to work well – it’s easy to implant, patients tolerate it well," Dr. Vivek Reddy of the Mount Sinai School of Medicine in New York told us today. "There are certainly going to be patients who are bad candidates for transvascular devices, but that’s a minority. The interesting question is, for the bigger potential population who could have a transvascular ICD, would this ICD be better? There are reasons to think it might. The most vulnerable part of the defibrillator is the lead. That’s why we have lead complications, we have fractures and shocks and articles in the New York Times.
"The point is that the devices do work, but they have significant rates of complications. If we could get around that with a subcutaneous, ICD, that would be a huge thing. The study I’d really like to see is a comparison between these 2 devices in most patients. It’s a very nice device, but it’s going to be for a select population. It’s not going to be for that 50% of the population or so that needs pacing," Reddy said.
Burke counters that the data from his IDE trial and from the Effortless registry show that, in fact, the device could address those under-served populations.
"If you really look at Effortless, you can see that the utilization of the device is actually broadening out to groups that are typically shunned, like the chronic renal failure group," he told us. "There’s a very high preponderance of chronic renal failure implants [in Effortless] and the data holds strong, in terms of safety and efficacy. Even in sicker populations, the complication rates hold at a very low rate over time."
Other critics, including at least 1 competitor speaking to MassDevice.com on background, say the S-ICD is a niche device because it doesn’t provide anti-tachycardia pacing or anti-Bradycardia pacing. But Burke argued that the patient population that needs ATP is the real niche.
"There’s a place for ATP in a very small part of the population," he said. "Most cardiac arrests in the field are patients who have known cardiac disease, but their heart failure is not that bad, where they’re getting routine medical treatment. Those patients die of ventricular fibrillation, they don’t die of ventricular tachycardia.
"I guarantee you a patient doesn’t want a lead in their heart, and I can say that after enrolling 13% of the patients in this particular [IDE] trial, because I offered them both transvenous and subcutaneous – and not just subcutaneous versus transvenous, but versus subcutaneous in an IDE trial which has the patient taking on risk. It’s very clear that the patient populations understands this," Burke said.
For the last word, we turned to Dr. Hugh Calkin of Johns Hopkins University’s cardiology division, who’s the president-elect of the Heart Rhythm Society.
"No matter how you slice it, this is a game-changer. How much of the game is changed is unclear," Calkin told us. "But there’s a reason that Boston Scientific took their option to acquire this device at a very hefty price. And that’s because they realize, and I think everyone in the space realizes, this is very, very significant. This is a game-changer."