With a rapidly growing population in demand for EP services, more technologies are coming to market to meet this patient need. Simultaneously, as traditional CV businesses decline, hospital executives are shifting their strategy towards EP to catalyze service line growth.
As a result, a wide range of physician specialties providers intend to enter this service. But as technology advancement continues, the question remains—who will actually perform these procedures in the future?
Leadless pacemakers a novel, optimistic approach to cardiac pacing
Within the EP device portfolio, leads are commonly touted as the “weakest link” of the CRM system due to challenges with durability, longevity, and extraction. While design innovation has addressed many of these difficulties, the larger goal is to ultimately eliminate leads altogether.
The Nanostim (St. Jude Medical), CE-marked in October 2013, is the first leadless cardiac pacemaker on the market. Initially revealed at HRS’s 2013 conference, the Nanostim technology uses a single unit for both pulse generation and sensing. This transvenous device is so small that it easily rests inside the heart’s right atrium.
Though not FDA approved, one-year follow-up results of the LEADLESS study presented at a HRS 2014 late-breaking trial session showed the device’s short procedure time, minimal infection risk, and pacing capabilities.
Leadless devices raise concerns regarding procedure ownership
Without leads complicating implantation, questions regarding physician ownership will inevitably surface. EP physicians have historically performed device implants, but the fully percutaneous approach to leadless pacemaker expands the number of specialties with the skillset to perform CRM device implantations. Any specialist with basic cardiac interventional skills—most notably interventional cardiologists—will likely have the expertise to perform this procedure.
Hospitals leaders interested in adopting this technology must anticipate potential turf wars between these specialties. Early planning and protocol creation will aid in establishing firm guidelines for physician ownership. Additionally, facilitating open lines of communication between administrators and all relevant stakeholders through regular meetings will be essential to addressing conflicts as they arise.
New devices may open appropriate use floodgates
Meanwhile, as a more efficient, less risky implant procedure, CRM implants will likely invite heightened scrutiny over appropriate utilization. If the leadless technology becomes FDA approved, it will be vital to proactively mitigate inappropriate use. Strategies such as embedding appropriate use criteria into routine clinical care and ensuring complete, accurate documentation can help alleviate these concerns.
Pending FDA approval, this technology can serve as a market differentiator and branding tool for EP programs eager to pave the way for an entirely new product line—one likely to be the way of the future for EP CRM devices.
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