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 Andrew Friedman, N. A Mark Estes, John Ip, Imran Niazi, Kenneth Plunkitt, Rajesh Banker, James Porterfield, James E. Ip, Srinivas R. Dukkipati

Research output: Contribution to journalArticle

198 Citations (Scopus)

Abstract

BACKGROUND Cardiac pacemakers are limited by device-related complications, notably infection and problems related to pacemaker leads. We studied a miniaturized, fully selfcontained 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 followup (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.).

Original languageEnglish (US)
Pages (from-to)1125-1135
Number of pages11
JournalNew England Journal of Medicine
Volume373
Issue number12
DOIs
StatePublished - Sep 17 2015

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Equipment and Supplies
Safety
Confidence Intervals
Multicenter Studies
Heart Ventricles
Catheters
Infection

ASJC Scopus subject areas

  • Medicine(all)

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Reddy, V. Y., Exner, D. V., Cantillon, D. J., Doshi, R., Bunch, T. J., Tomassoni, G. F., ... Dukkipati, S. R. (2015). Percutaneous implantation of an entirely intracardiac leadless pacemaker. New England Journal of Medicine, 373(12), 1125-1135. https://doi.org/10.1056/NEJMoa1507192

Percutaneous implantation of an entirely intracardiac leadless pacemaker. / Reddy, Vivek Y.; Exner, Derek V.; Cantillon, Daniel J.; Doshi, Rahul; Bunch, T. Jared; Tomassoni, Gery F.; Friedman, Paul Andrew; Estes, N. A Mark; Ip, John; Niazi, Imran; Plunkitt, Kenneth; Banker, Rajesh; Porterfield, James; Ip, James E.; Dukkipati, Srinivas R.

In: New England Journal of Medicine, Vol. 373, No. 12, 17.09.2015, p. 1125-1135.

Research output: Contribution to journalArticle

Reddy, VY, Exner, DV, Cantillon, DJ, Doshi, R, Bunch, TJ, Tomassoni, GF, Friedman, PA, Estes, NAM, Ip, J, Niazi, I, Plunkitt, K, Banker, R, Porterfield, J, Ip, JE & Dukkipati, SR 2015, 'Percutaneous implantation of an entirely intracardiac leadless pacemaker', New England Journal of Medicine, vol. 373, no. 12, pp. 1125-1135. https://doi.org/10.1056/NEJMoa1507192
Reddy VY, Exner DV, Cantillon DJ, Doshi R, Bunch TJ, Tomassoni GF et al. Percutaneous implantation of an entirely intracardiac leadless pacemaker. New England Journal of Medicine. 2015 Sep 17;373(12):1125-1135. https://doi.org/10.1056/NEJMoa1507192
Reddy, Vivek Y. ; Exner, Derek V. ; Cantillon, Daniel J. ; Doshi, Rahul ; Bunch, T. Jared ; Tomassoni, Gery F. ; Friedman, Paul Andrew ; Estes, N. A Mark ; Ip, John ; Niazi, Imran ; Plunkitt, Kenneth ; Banker, Rajesh ; Porterfield, James ; Ip, James E. ; Dukkipati, Srinivas R. / Percutaneous implantation of an entirely intracardiac leadless pacemaker. In: New England Journal of Medicine. 2015 ; Vol. 373, No. 12. pp. 1125-1135.
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abstract = "BACKGROUND Cardiac pacemakers are limited by device-related complications, notably infection and problems related to pacemaker leads. We studied a miniaturized, fully selfcontained 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 followup (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.).",
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T1 - Percutaneous implantation of an entirely intracardiac leadless pacemaker

AU - Reddy, Vivek Y.

AU - Exner, Derek V.

AU - Cantillon, Daniel J.

AU - Doshi, Rahul

AU - Bunch, T. Jared

AU - Tomassoni, Gery F.

AU - Friedman, Paul Andrew

AU - Estes, N. A Mark

AU - Ip, John

AU - Niazi, Imran

AU - Plunkitt, Kenneth

AU - Banker, Rajesh

AU - Porterfield, James

AU - Ip, James E.

AU - Dukkipati, Srinivas R.

PY - 2015/9/17

Y1 - 2015/9/17

N2 - BACKGROUND Cardiac pacemakers are limited by device-related complications, notably infection and problems related to pacemaker leads. We studied a miniaturized, fully selfcontained 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 followup (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.).

AB - BACKGROUND Cardiac pacemakers are limited by device-related complications, notably infection and problems related to pacemaker leads. We studied a miniaturized, fully selfcontained 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 followup (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.).

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