Percutaneous Implantation of an Entirely Intracardiac Leadless Pacemaker
Vivek Y Reddy, Derek V Exner, Daniel J Cantillon, Rahul Doshi, T Jared Bunch, Gery F Tomassoni, Paul A Friedman, N A Mark Estes 3rd, John Ip, Imran Niazi, Kenneth Plunkitt, Rajesh Banker, James Porterfield, James E Ip, Srinivas R Dukkipati, LEADLESS II Study Investigators, John Ip, Srinivas R Dukkipati, Kenneth Plunkitt, Gery Tomassoni, Imran Niazi, Rajesh Banker, Kent Nilsson, James Porterfield, James Allred, Mayer Rashtian, Sri Sundaram, James E Ip, Rob Patrawala, Judith Mackall, Sohail Hassan, Daniel Cantillon, Jihn Han, Harish Doppalapudi, Brian Jaffe, Amit Doshi, Steven Higgins, Dhanunjaya Lakkireddy, Joseph Levine, T Jared Bunch, Quan Pham, Sammy Lane Cox, Rahul Doshi, Jay Dinerman, Paul Friedman, Robert Styperek, Gearoid O'Neill, Ashish Patel, Manoj Duggal, Mohamad Sinno, Scott Pollak, Michael Bernard, Moussa Mansour, Bruce Hook, Brett Atwater, Bing Liem, Sandeep Jain, Charles Machell, Michael Mirro, Lyle Siddoway, Richard Lane, Ramesh Hariharan, Martin Burke, Adam Strickberger, Jonathan Weinstock, David Bello, Derek Exner, Matthew Bennett, Bernice Tsang, Bernard Thibault, Prashanthan Sanders, John Hill, Vivek Y Reddy, Derek V Exner, Daniel J Cantillon, Rahul Doshi, T Jared Bunch, Gery F Tomassoni, Paul A Friedman, N A Mark Estes 3rd, John Ip, Imran Niazi, Kenneth Plunkitt, Rajesh Banker, James Porterfield, James E Ip, Srinivas R Dukkipati, LEADLESS II Study Investigators, John Ip, Srinivas R Dukkipati, Kenneth Plunkitt, Gery Tomassoni, Imran Niazi, Rajesh Banker, Kent Nilsson, James Porterfield, James Allred, Mayer Rashtian, Sri Sundaram, James E Ip, Rob Patrawala, Judith Mackall, Sohail Hassan, Daniel Cantillon, Jihn Han, Harish Doppalapudi, Brian Jaffe, Amit Doshi, Steven Higgins, Dhanunjaya Lakkireddy, Joseph Levine, T Jared Bunch, Quan Pham, Sammy Lane Cox, Rahul Doshi, Jay Dinerman, Paul Friedman, Robert Styperek, Gearoid O'Neill, Ashish Patel, Manoj Duggal, Mohamad Sinno, Scott Pollak, Michael Bernard, Moussa Mansour, Bruce Hook, Brett Atwater, Bing Liem, Sandeep Jain, Charles Machell, Michael Mirro, Lyle Siddoway, Richard Lane, Ramesh Hariharan, Martin Burke, Adam Strickberger, Jonathan Weinstock, David Bello, Derek Exner, Matthew Bennett, Bernice Tsang, Bernard Thibault, Prashanthan Sanders, John Hill
Abstract
Background: Cardiac pacemakers are limited by device-related complications, notably infection and problems related to pacemaker leads. We studied a miniaturized, fully self-contained leadless pacemaker that is nonsurgically implanted in the right ventricle with the use of a catheter.
Methods: In this multicenter study, we implanted an active-fixation leadless cardiac pacemaker in patients who required permanent single-chamber ventricular pacing. The primary efficacy end point was both an acceptable pacing threshold (≤2.0 V at 0.4 msec) and an acceptable sensing amplitude (R wave ≥5.0 mV, or a value equal to or greater than the value at implantation) through 6 months. The primary safety end point was freedom from device-related serious adverse events through 6 months. In this ongoing study, the prespecified analysis of the primary end points was performed on data from the first 300 patients who completed 6 months of follow-up (primary cohort). The rates of the efficacy end point and safety end point were compared with performance goals (based on historical data) of 85% and 86%, respectively. Additional outcomes were assessed in all 526 patients who were enrolled as of June 2015 (the total cohort).
Results: The leadless pacemaker was successfully implanted in 504 of the 526 patients in the total cohort (95.8%). The intention-to-treat primary efficacy end point was met in 270 of the 300 patients in the primary cohort (90.0%; 95% confidence interval [CI], 86.0 to 93.2, P=0.007), and the primary safety end point was met in 280 of the 300 patients (93.3%; 95% CI, 89.9 to 95.9; P<0.001). At 6 months, device-related serious adverse events were observed in 6.7% of the patients; events included device dislodgement with percutaneous retrieval (in 1.7%), cardiac perforation (in 1.3%), and pacing-threshold elevation requiring percutaneous retrieval and device replacement (in 1.3%).
Conclusions: The leadless cardiac pacemaker met prespecified pacing and sensing requirements in the large majority of patients. Device-related serious adverse events occurred in approximately 1 in 15 patients. (Funded by St. Jude Medical; LEADLESS II ClinicalTrials.gov number, NCT02030418.).
Source: PubMed