TY - JOUR
T1 - A Leadless Intracardiac Transcatheter Pacing System
AU - Reynolds, Dwight
AU - Duray, Gabor Z.
AU - Omar, Razali
AU - Soejima, Kyoko
AU - Neuzil, Petr
AU - Zhang, Shu
AU - Narasimhan, Calambur
AU - Steinwender, Clemens
AU - Brugada, Josep
AU - Lloyd, Michael
AU - Roberts, Paul R.
AU - Sagi, Venkata
AU - Hummel, John
AU - Bongiorni, Maria Grazia
AU - Knops, Reinoud E.
AU - Ellis, Christopher R.
AU - Gornick, Charles C.
AU - Bernabei, Matthew A.
AU - Laager, Verla
AU - Stromberg, Kurt
AU - Williams, Eric R.
AU - Hudnall, J. Harrison
AU - Ritter, Philippe
AU - AUTHOR GROUP
AU - Duray, Gabor Zoltan
AU - Roberts, Paul
AU - Gornick, Charles
AU - Ellis, Christopher
AU - Gonzalez, Efrain
AU - Boersma, Lucas V. A.
AU - Chinitz, Larry
AU - Bernabei, Matthew
AU - Shinn, Timothy
AU - Jones, Randy
AU - Schoenhard, John
AU - Kusano, Kengo
AU - Philippon, Francois
AU - Atwater, Brett
AU - Voigt, Andrew
AU - Asano, Taku
AU - Kowal, Robert
AU - Simmers, Timothy Alexander
AU - Milasinovic, Goran
AU - Bahl, Vinay Kumar
AU - Seger, John
AU - Shehata, Michael
AU - Thibault, Bernard T.
AU - Ishikawa, Toshiyuki
AU - Sra, Jasbir
AU - Giocondo, Michael
AU - Johnson, Eric
PY - 2016
Y1 - 2016
N2 - A leadless intracardiac transcatheter pacing system has been designed to avoid the need for a pacemaker pocket and transvenous lead. 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. 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). 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.)
AB - A leadless intracardiac transcatheter pacing system has been designed to avoid the need for a pacemaker pocket and transvenous lead. 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. 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). 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.)
U2 - https://doi.org/10.1056/NEJMoa1511643
DO - https://doi.org/10.1056/NEJMoa1511643
M3 - Article
C2 - 26551877
SN - 0028-4793
VL - 374
SP - 533
EP - 541
JO - New England journal of medicine
JF - New England journal of medicine
IS - 6
ER -