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

Kód výsledku v 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>

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

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

Popis výsledku anglicky

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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30201 - Cardiac and Cardiovascular systems

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2015

Kód důvěrnosti údajů

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

Název periodika

European Heart Journal

ISSN

0195-668X

e-ISSN

—

Svazek periodika

36

Číslo periodika v rámci svazku

37

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

10

Strana od-do

2510-2519

Kód UT WoS článku

000362824500011

EID výsledku v databázi Scopus

2-s2.0-84940476913