Vivek Y Reddy1, Derek V Exner, Daniel J Cantillon, Rahul Doshi, T Jared Bunch, Gery F Tomassoni, Paul A Friedman, N A Mark Estes, John Ip, Imran Niazi, Kenneth Plunkitt, Rajesh Banker, James Porterfield, James E Ip, Srinivas R Dukkipati. 1. From the Icahn School of Medicine at Mount Sinai (V.Y.R., S.R.D.) and Weill Cornell Medical Center (J.E.I.) - both in New York; Libin Cardiovascular Institute of Alberta, Calgary, Canada (D.V.E.); Cleveland Clinic, Cleveland (D.J.C.); Keck Hospital of University of Southern California, Los Angeles (R.D.), and Premier Cardiology, Newport Beach (R.B.) - both in California; Intermountain Medical Center Heart Institute, Salt Lake City, (T.J.B.); Central Baptist Hospital, Lexington, KY (G.F.T.); Mayo Clinic, Rochester, MN (P.A.F.); Tufts University School of Medicine, Boston (N.A.M.E.); Sparrow Clinical Research Institute, Lansing, MI (J.I.); Aurora Medical Group, Milwaukee (I.N.); Naples Community Hospital, Naples, FL (K.P.); and Methodist University Hospital, Memphis, TN (J.P.).
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.).
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.).
Authors: Ammar M Killu; Niyada Naksuk; Zdeněk Stárek; Christopher V DeSimone; Faisal F Syed; Prakriti Gaba; Jiří Wolf; Frantisek Lehar; Martin Pesl; Pavel Leinveber; Michal Crha; Dorothy Ladewig; Joanne Powers; Scott Suddendorf; David O Hodge; Gaurav Satam; Miroslav Novák; Tomas Kara; Charles J Bruce; Paul A Friedman; Samuel J Asirvatham Journal: JACC Clin Electrophysiol Date: 2017-07
Authors: Chin C Lee; Khuyen Do; Sati Patel; Steven K Carlson; Tomas Konecny; Philip M Chang; Rahul N Doshi Journal: J Interv Card Electrophysiol Date: 2019-08-20 Impact factor: 1.900
Authors: Jonathan S Gordon; Elizabeth J Maynes; Thomas J O'Malley; Behzad B Pavri; Vakhtang Tchantchaleishvili Journal: J Interv Card Electrophysiol Date: 2021-01-12 Impact factor: 1.900