A leadless pacemaker in the real-world setting: The Micra Transcatheter Pacing System Post-Approval Registry
Por:
Roberts, PR, Clementy, N, Al Samadi, F, Garweg, C, Martinez-Sande, JL, Iacopino, S, Johansen, JB, Prat, XV, Kowal, RC, Klug, D, Mont, L, Steffel, J, Li, S, Van Osch, D, El-Chami, MF
Publicada:
1 sep 2017
Resumen:
BACKGROUND First-in-man studies of leadless pacemakers have demonstrated high rates of implant success, and safety and efficacy objectives were achieved. Outside of the investigational setting, there are concerns, particularly over cardiac effusion and perforation, device dislodgement, infection, telemetry, and battery issues. OBJECTIVE The acute performance of the Micra transcatheter pacemaker from a worldwide Post-Approval Registry is reported.
METHODS The registry is an ongoing prospective single-arm observational study designed to assess the safety and effectiveness of Micra in the post-approval setting. The safety end point was systemor procedure-related major complications at 30 days post implant. We compared the major complication rate with that of the 726 patients from the investigational study. Electrical performance was also characterized.
RESULTS The device was successfully implanted in 792 of 795 registry patients (99.6%) by 149 implanters at 96 centers in 20 countries. Through 30 days post implant, a total of 13 major complications occurred in 12 patients, for a major complication rate of 1.51% (95% confidence interval, 0.78%-2.62%). Major complications included cardiac effusion/ perforation (1, 0.13%), device dislodgement (1, 0.13%), and sepsis (1, 0.13%). After adjusting for baseline differences, the rate ofmajor complications in the registry trended lower than the investigational trial (odds ratio, 0.58, 95% confidence interval, 0.27-1.25; P - .16). Early pacing capture thresholds were low and stable.
CONCLUSION Performance of the Micra transcatheter pacemaker in a real-world setting demonstrates a high rate (99.6%) of implant success and low rate (1.51%) of major complications through 30 days post implant. In particular, the rates of pericardial effusion, device dislodgement, and infection were low, reinforcing the positive results seen in the investigational study.
Filiaciones:
Roberts, PR:
Univ Hosp Southampton NHS Fdn Trust, Southampton Gen Hosp, Southampton, Hants, England
Clementy, N:
Ctr Hosp Reg Univ Tours, Hop Trousseau, Tours, France
Al Samadi, F:
King Fahad Med City, King Salman Heart Ctr, Riyadh, Saudi Arabia
Garweg, C:
Univ Ziekenhuizen Leuven, Campus Gasthuisberg, Leuven, Belgium
Martinez-Sande, JL:
Univ Clin Hosp Santiago de Compostela, Santiago De Compostela, Spain
Iacopino, S:
Maria Cecilia Hosp, Arrhythmol Dept, Electrophysiol Unit, Cotignola, Italy
Johansen, JB:
Odense Univ Hosp, Dept Cardiol, Odense, Denmark
Prat, XV:
Hosp Santa Creu & Sant Pau, Arrhythmia Unit, Barcelona, Spain
Kowal, RC:
Baylor Univ, Baylor Scott & White Healthcare, Dallas, TX USA
Medtronic, Mounds View, MN USA
Klug, D:
Ctr Hosp Reg Univ Lille, Lille, France
Mont, L:
Hosp Univ Clin Barcelona, Barcelona, Spain
Steffel, J:
Univ Spital Zurich, Zurich, Switzerland
Li, S:
Medtronic, Mounds View, MN USA
Van Osch, D:
Medtron Bakken Res Ctr, Maastricht, Netherlands
El-Chami, MF:
Emory Univ, Div Cardiol, Sect Electrophysiol, Atlanta, GA 30322 USA
Green Published, hybrid
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