Innovative heart rhythm technologies that do away with the leads that "tether" the device to the heart may be the next big thing for heart failure patients, but the technology has a way to go before disrupting the market, according to panelists at the Cardiostim 2012 conference in France this week.
Getting rid of the leads that weave through the body to deliver shocks to the heart would mean doing away with risks including lead fractures, erosion and infections, Cleveland Clinic’s Dr. Bruce Wilkoff told an audience at a popular presentation.
But the technology has a ways to go before lead-free pacemakers and implantable cardioverter defibrillators can overtake their tethered predecessors.
Innovators will initially need to overcome battery power hurdles, TheHeart.org reported. Luckily for device makers, several companies are already working on new power sources, including a self-recharging battery that harnesses the natural movement of the heart and technologies that could wirelessly deliver energy from outside of the body.
The other hurdle lead-free device makers will face is that the devices can’t deliver antitachycardia pacing, which many heart failure patients need in addition to pacing.
The technology to bridge that gap doesn’t exist yet, but patients may 1 day get separate implants for the individual therapies, some panelists said. Others remained skeptical that doctors should pin their hopes on lead-free technology, especially given the dearth of clinical evidence demonstrating that they can truly keep up with implants using leads.
"We simply do not have very good long-term data," University of Würzburg’s Dr. Johannes Brachmann said. "They’re just assuming this system can provide the same information and the same effectiveness as the existing devices, but this has never been proven."
"We need sound evidence to use this technology," he added. "This will not be technology that can be easily implemented. It will require major investments on the part of industry."
Brachmann’s not alone in his skepticism. Some analysts have warned that Cameron Health’s lead-free ICD may be more of a niche product than a game-changer.
The Cameron S-ICD, which is slightly larger than traditional ICDs, is implanted under the arm. Its major innovation is that the leads that transmit electricity to the heart are implanted in a surgically created channel along the patient’s chest, rather than being threaded through blood vessels.
"Our view remains that the Cameron [device] … is likely to be niche product," Goldman Sachs analyst David Roman wrote in a note to investors in April. J.P. Morgan analyst Michael Weinstein agreed, writing in a separate note that the larger S-ICD device, which also delivers larger and potentially more painful shocks, may not be so alluring to patients.
"For the vast majority of patients, the transvenous lead is still [a technology] we can apply with a great deal of certainty," Brachmann said during the panel. "The vast majority of patients do very well with transvenous leads today."