A Leadless Intracardiac Transcatheter Pacing System
Dwight Reynolds, Gabor Z Duray, Razali Omar, Kyoko Soejima, Petr Neuzil, Shu Zhang, Calambur Narasimhan, Clemens Steinwender, Josep Brugada, Michael Lloyd, Paul R Roberts, Venkata Sagi, John Hummel, Maria Grazia Bongiorni, Reinoud E Knops, Christopher R Ellis, Charles C Gornick, Matthew A Bernabei, Verla Laager, Kurt Stromberg, Eric R Williams, J Harrison Hudnall, Philippe Ritter, Micra Transcatheter Pacing Study Group, Gabor Zoltan Duray, Josep Brugada, Clemens Steinwender, Petr Neuzil, Philippe Ritter, Michael Lloyd, Venkata Sagi, Paul Roberts, John Hummel, Razali Omar, Reinoud E Knops, Charles Gornick, Maria Grazia Bongiorni, Christopher Ellis, Efrain Gonzalez, Lucas V A Boersma, Larry Chinitz, Matthew Bernabei, Kyoko Soejima, Timothy Shinn, Randy Jones, John Schoenhard, Calambur Narasimhan, Kengo Kusano, Francois Philippon, Brett Atwater, Andrew Voigt, Taku Asano, Robert Kowal, Timothy Alexander Simmers, Goran Milasinovic, Vinay Kumar Bahl, John Seger, Michael Shehata, Bernard T Thibault, Toshiyuki Ishikawa, Jasbir Sra, Michael Giocondo, Eric Johnson, Shu Zhang, Bruce Wilkoff, Jack Collier, John Hill, Panos E Vardas, Suneet Mittal, Eric Grubman, John Ferguson, Jesper Hastrup Svendsen, Ashley Chin, John Rogers, Ram Jadonath, Sanjay Tyagi, Magdi Ghali, Robert Coyne, Dwight Reynolds, Douglas Esberg, Dwight Reynolds, Philippe Ritter, Gabor Duray, Shu Zhang, Calambur Narasimhan, Razali Omar, Kyoko Soejima, Dwight Reynolds, Gabor Z Duray, Razali Omar, Kyoko Soejima, Petr Neuzil, Shu Zhang, Calambur Narasimhan, Clemens Steinwender, Josep Brugada, Michael Lloyd, Paul R Roberts, Venkata Sagi, John Hummel, Maria Grazia Bongiorni, Reinoud E Knops, Christopher R Ellis, Charles C Gornick, Matthew A Bernabei, Verla Laager, Kurt Stromberg, Eric R Williams, J Harrison Hudnall, Philippe Ritter, Micra Transcatheter Pacing Study Group, Gabor Zoltan Duray, Josep Brugada, Clemens Steinwender, Petr Neuzil, Philippe Ritter, Michael Lloyd, Venkata Sagi, Paul Roberts, John Hummel, Razali Omar, Reinoud E Knops, Charles Gornick, Maria Grazia Bongiorni, Christopher Ellis, Efrain Gonzalez, Lucas V A Boersma, Larry Chinitz, Matthew Bernabei, Kyoko Soejima, Timothy Shinn, Randy Jones, John Schoenhard, Calambur Narasimhan, Kengo Kusano, Francois Philippon, Brett Atwater, Andrew Voigt, Taku Asano, Robert Kowal, Timothy Alexander Simmers, Goran Milasinovic, Vinay Kumar Bahl, John Seger, Michael Shehata, Bernard T Thibault, Toshiyuki Ishikawa, Jasbir Sra, Michael Giocondo, Eric Johnson, Shu Zhang, Bruce Wilkoff, Jack Collier, John Hill, Panos E Vardas, Suneet Mittal, Eric Grubman, John Ferguson, Jesper Hastrup Svendsen, Ashley Chin, John Rogers, Ram Jadonath, Sanjay Tyagi, Magdi Ghali, Robert Coyne, Dwight Reynolds, Douglas Esberg, Dwight Reynolds, Philippe Ritter, Gabor Duray, Shu Zhang, Calambur Narasimhan, Razali Omar, Kyoko Soejima
Abstract
Background: A leadless intracardiac transcatheter pacing system has been designed to avoid the need for a pacemaker pocket and transvenous lead.
Methods: In a prospective multicenter study without controls, a transcatheter pacemaker was implanted in patients who had guideline-based indications for ventricular pacing. The analysis of the primary end points began when 300 patients reached 6 months of follow-up. The primary safety end point was freedom from system-related or procedure-related major complications. The primary efficacy end point was the percentage of patients with low and stable pacing capture thresholds at 6 months (≤2.0 V at a pulse width of 0.24 msec and an increase of ≤1.5 V from the time of implantation). The safety and efficacy end points were evaluated against performance goals (based on historical data) of 83% and 80%, respectively. We also performed a post hoc analysis in which the rates of major complications were compared with those in a control cohort of 2667 patients with transvenous pacemakers from six previously published studies.
Results: The device was successfully implanted in 719 of 725 patients (99.2%). The Kaplan-Meier estimate of the rate of the primary safety end point was 96.0% (95% confidence interval [CI], 93.9 to 97.3; P<0.001 for the comparison with the safety performance goal of 83%); there were 28 major complications in 25 of 725 patients, and no dislodgements. The rate of the primary efficacy end point was 98.3% (95% CI, 96.1 to 99.5; P<0.001 for the comparison with the efficacy performance goal of 80%) among 292 of 297 patients with paired 6-month data. Although there were 28 major complications in 25 patients, patients with transcatheter pacemakers had significantly fewer major complications than did the control patients (hazard ratio, 0.49; 95% CI, 0.33 to 0.75; P=0.001).
Conclusions: In this historical comparison study, the transcatheter pacemaker met the prespecified safety and efficacy goals; it had a safety profile similar to that of a transvenous system while providing low and stable pacing thresholds. (Funded by Medtronic; Micra Transcatheter Pacing Study ClinicalTrials.gov number, NCT02004873.).
Source: PubMed