June 14, 2014

Anytime a new technology comes with the suffix “less,” I get interested. Less, as in leadless implanted devices, may indeed be the future of cardiac pacing. Multiple studies presented here at CardioStim 2014 lend credence to such a bold statement.

The stuffy and small conference room was as packed as I have ever seen one. Attendees lined the walls, aisles, and even sat on the floor. As I sat there in a rickety chair, I worried about a vasovagal episode, falling onto my lap and laptop.

The session was given the provocative title, “Revolutionary Technologies for Implantable Devices.” The first presentation included the terms, “First-in-man . . . ”

The tech-hungry crowd, therefore, was not surprising.

The driving force for devising a way to stimulate the heart without permanent transvenous leads is the impossibility of engineering the perfect lead. I had a student with me recently during an implant, and she asked a question that many of us experienced electrophysiologists easily forget: “Does that lead do damage going through the veins and heart valves?” It was striking that even a novice could recognize the weak link of current pacing systems.

So it is that companies big and small are entering the race to develop a wireless pacing system.

heartwire journalist Michael O’Riordan has this coverage of the very early (as in four patients early) experience with the Medtronic Micra self-contained leadless RV pacing device[1]Dr Clemens Steinwender (Linz General Hospital, Austria) presented their experience with the 2-g self-contained device, which is delivered through a deflectable sheath placed via a femoral approach. Much like the St Jude Medical NanoStim leadless pacemaker, except with tines instead of a screw, the Micra device provides excellent acute pacing performance. The one-month follow-up pacing parameters remained unchanged, and no complications were observed.

In the following presentation, Dr Fleur Tjong (Academic Medical Center, Amsterdam, the Netherlands) presented one-year follow-up of their eight patients from the original 33 patients enrolled in theLEADLESS trial, which enrolled 33 patients implanted with the NanoStim leadless pacemaker[2]. This trial was last updated at Heart Rhythm Society Sessions last month. The Dutch team reported today that their eight patients had excellent pacing parameters, rate-responsive functionality, and no adverse effects.

The St Jude NanoStim device has a clear head start in the leadless pacing race, with two trials, one inNorth America and another in Europe, currently enrolling patients.

Leadless in the LV?

Leadless pacing isn’t just going on in the right ventricle. Remarkably, the technology is also being considered and studied in the left ventricle (LV). That’s right, a metal lead on the arterial side of the circulation.

The idea is to offer cardiac resynchronization to the 10% to 20% of CRT-eligible patients who are not suitable for transvenous coronary sinus leads. These patients have a problem because the only option at this point is to surgically place an epicardial lead, which, despite some surgeons’ opinion, is far from “less” invasive.


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