Hauser: Don’t 'improve' reliable ICD leads

Implantable cardioverter-defibrillator (ICD) leads that are durable over the long term are available, and physicians should use them and “demand that industry leave them alone,” Robert G. Hauser, MD, of the Minneapolis Heart Institute Foundation, recommended in a viewpoint published online Feb. 15 in HeartRhythm.

Hauser reviewed the success of ICDs in preventing sudden cardiac death, but lamented the eagerness of some physicians to adopt leads of smaller diameter without evidence that they were more effective. He wrote that innovations and improvements in ICDs have focused on design—making the devices smaller, more flexible, etc.—rather than reliability and efforts to gain market share spurred manufacturers to introduce new leads without sufficient human studies or data on long-term performance.

Noting that ICD implantation is a safe procedure if performed by an experienced operator, Hauser pointed out that the limited durability of the leads is the major driver of poor outcomes, and that “ICD lead extraction has become a subspecialty, including centers of excellence and a thriving industry that supplies the tools.”  

He named Quattro Secure (Medtronic) and the Endotak Reliance (Boston Scientific) as leads with a history of reliability and durability, with more than 95 percent still operational after eight years. “These leads appear capable of providing the reliability needed to achieve the ‘one lead one lifetime’ goal we desire for patients, and their manufacturers should continue to supply them without modification,” Hauser emphasized.

As for lead development in the future, Hauser suggested that correlating bench testing with knowledge gained from clinical studies and known mechanisms of failure may obviate the need for clinical trials. He also recommended that registries and post-market surveys make use of cutting-edge statistical analysis techniques to identify potential failures or problems before large numbers of patients have received the devices.

Hauser was critical of the FDA’s approval of “class 3 life-supporting devices as supplements to obsolete devices that were discarded years ago,” and cautioned against “experimenting with new leads outside the context of investigational studies that require institutional review board approval and informed consent.” He exhorted physicians to limit their implantations to leads with well-established records of reliability and durability and called for manufacturers to continue to supply them.