Early performance of a miniaturized leadless cardiac pacemaker: the Micra Transcatheter Pacing Study

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023884%3A_____%2F15%3A00007807" target="_blank" >RIV/00023884:_____/15:00007807 - isvavai.cz</a>

Result on the web

<a href="http://dx.doi.org/10.1093/eurheartj/ehv214" target="_blank" >http://dx.doi.org/10.1093/eurheartj/ehv214</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1093/eurheartj/ehv214" target="_blank" >10.1093/eurheartj/ehv214</a>

Result language

angličtina

Original language name

Early performance of a miniaturized leadless cardiac pacemaker: the Micra Transcatheter Pacing Study

Original language description

Aims Permanent cardiac pacing is the only effective treatment for symptomatic bradycardia, but complications associated with conventional transvenous pacing systems are commonly related to the pacing lead and pocket. We describe the early performance of a novel self-contained miniaturized pacemaker. Methods and results Patients having Class I or II indication for VVI pacing underwent implantation of a Micra transcatheter pacing system, from the femoral vein and fixated in the right ventricle using four protractible nitinol tines. Prespecified objectives were >85% freedom from unanticipated serious adverse device events (safety) and <2 V 3-month mean pacing capture threshold at 0.24 ms pulse width (efficacy). Patients were implanted (n = 140) from 23 centres in 11 countries (61% male, age 77.0 +/- 10.2 years) for atrioventricular block (66%) or sinus node dysfunction (29%) indications. During mean follow-up of 1.9 +/- 1.8 months, the safety endpoint was met with no unanticipated serious adverse device events. Thirty adverse events related to the system or procedure occurred, mostly due to transient dysrhythmias or femoral access complications. One pericardial effusion without tamponade occurred after 18 device deployments. In 60 patients followed to 3 months, mean pacing threshold was 0.51 +/- 0.22 V, and no threshold was >= 2 V, meeting the efficacy endpoint (P < 0.001). Average R-wave was 16.1 +/- 5.2 mV and impedance was 650.7 +/- 130 ohms. Conclusion Early assessment shows the transcatheter pacemaker can safely and effectively be applied. Long-term safety and benefit of the pacemaker will further be evaluated in the trial.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

30201 - Cardiac and Cardiovascular systems

Project

—

Continuities

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Publication year

2015

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

European Heart Journal

ISSN

0195-668X

e-ISSN

—

Volume of the periodical

36

Issue of the periodical within the volume

37

Country of publishing house

GB - UNITED KINGDOM

Number of pages

10

Pages from-to

2510-2519

UT code for WoS article

000362824500011

EID of the result in the Scopus database

2-s2.0-84940476913