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Leadless cardiac pacemaker safe, effective in first-in-man study
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DENVER — A novel leadless cardiac pacemaker for right ventricular pacing appears to be safe, effective and feasible.
The first-in-man, prospective, nonrandomized, single-arm, multicenter LEADLESS study evaluated in vivo implantation of an intracardiac leadless pacemaker (Nanostim, Inc.) in 33 patients (mean age, 75 years) requiring a permanent VVI(R) pacemaker.
Vivek Y. Reddy, MD, professor of medicine at Mount Sinai School of Medicine in New York, presented findings from the feasibility study at the Heart Rhythm Society’s Annual Scientific Sessions.
Vivek Y. Reddy
The single-chamber leadless pacemaker was successfully implanted in 32 of the 33 patients via the right ventricular apex using a deflectable 18F sheath under fluoroscopic guidance. The implant success rate was 97%. In two cases, the device had to be removed after implantation. In both cases the device was re-implanted successfully.
“The device is able to be implanted successfully and retrieved successfully,” Reddy said at a press conference.
Electrical primers were evaluated post-implant at 2 days, 2 weeks, 6 weeks and 3 months. Results show that pacing threshold, R-wave amplitude and impedance were similar to traditional pacemakers with leads, Reddy said.
No significant groin complications emerged. One patient experienced a minor hematoma that required no treatment or extended hospitalization. In the one patient in whom implantation was unsuccessful, cardiac perforation during device deployment resulted in tamponade; surgical intervention was successful, but the patient sustained an in-hospital stroke and died.
Implant procedure time averaged 28 minutes and decreased with experience (range, 11 minutes to 74 minutes). Most patients were discharged from the hospital within 1 day after the procedure (range, 1 to 4 days). Average catheter delivery time was 16 minutes (range, 3 minutes to 57 minutes). Mean number of times the catheter required repositioning was 0.5; 23 patients did not require repositioning; in two patients it was possible to reposition up to three times.
Battery life of the device is expected to be 8 to 17 years.
“This study represents a real paradigm shift in how we will look at pacemakers. The intracardiac leadless pacemaker seems to function just like a traditional pacemaker,” Reddy said. “The major benefit is avoiding the complication of fractured leads and the risk of infection in high-risk patients.” – by Deb Dellapena
For more information:
Reddy V. LB02-01. Presented at: Heart Rhythm Society’s Annual Scientific Sessions; May 8-11, 2013; Denver.
Disclosure: Reddy reports equity/stock in Nanostim.
Perspective
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Michael R. Gold, MD, PhD
The results clearly support the hypothesis that we can implant a miniature, fully functional pacemaker without leads in a patient. This is the first time it has ever been shown in humans. The study went very well for a new type of device; these are very nice results.
Once it is shown that the device is safe and efficacious in these first-in-human studies, a clinical trial will be developed. It is not yet clear whether that design will be an observational trial or a randomized trial against a transvenous pacemaker with leads, but it will likely require longer follow-up.
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